As
filed with the Securities and Exchange Commission on July 24, 2023
Registration Statement No 333-
UNITED STATES |
SECURITIES AND EXCHANGE COMMISSION |
Washington, D.C. 20549 |
|
|
FORM
S-1 |
REGISTRATION STATEMENT |
UNDER |
THE SECURITIES ACT OF 1933 |
|
|
Cadrenal
Therapeutics, Inc. |
(Exact name of Registrant as specified in its charter) |
|
Delaware | | 2834 | | 88-0860746 |
(State or other jurisdiction of
incorporation or organization) | | (Primary Standard Industrial
Classification Code Number) | | (I.R.S. Employer
Identification Number) |
822 A1A North, Suite 306
Ponte Vedra, Florida 32082
(904) 300-0701
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices) |
|
Quang Pham
President, Chief Executive Officer and Director
Cadrenal Therapeutics, Inc.
822 A1A North, Suite 306
Ponte Vedra, Florida 32082
(904) 300-0701
(Name, address, including zip code, and telephone number, including area code, of agent for service) |
|
Copies to:
Leslie Marlow, Esq.
Hank Gracin, Esq.
Patrick J. Egan, Esq.
Blank Rome LLP
1271 Avenue of the Americas
New York, New York 10020
Tel: (212) 885-5000
Approximate date of commencement of proposed
sale to the public: As soon as practicable after the effective date of this registration statement.
If any of the securities being registered on this
form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following
box. ☒
If this form is filed to register additional securities
for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. ☐
If this form is a post-effective amendment filed
pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number
of the earlier effective registration statement for the same offering. ☐
If this form is a post-effective amendment filed
pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number
of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | Emerging growth company | ☒ |
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The information contained
in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement
filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities
and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
PRELIMINARY
PROSPECTUS |
SUBJECT
TO COMPLETION |
DATED
JULY 24, 2023 |
8,850,001 Shares
Common Stock
Cadrenal Therapeutics, Inc.
This prospectus relates to the resale from time
to time of up to 8,850,001 shares of Common Stock, par value $0.001 per share (the “Common Stock”), of Cadrenal Therapeutics,
Inc. by the selling stockholders identified in this prospectus (the “Selling Stockholders”), including their pledgees, assignees,
donees, transferees or their respective successors-in-interest consisting of (i) 1,300,000 shares of Common Stock purchased by a Selling
Stockholder (the “Investor Selling Stockholder”) in a private placement transaction that closed on July 14, 2023 (the “Private
Placement”) (the “Shares”), (ii) 2,985,715 shares of Common Stock issuable upon the exercise of outstanding pre-funded
warrants (the “Pre-Funded Warrants”) to purchase shares of Common Stock purchased by the Investor Selling Stockholder in the
Private Placement, (iii) 4,285,715 shares of Common Stock issuable upon the exercise of outstanding warrants to purchase shares of Common
Stock purchased by the Investor Selling Stockholder in the Private Placement (the “Common Warrants”) and (iv) 278,571 shares
of Common Stock issuable upon the exercise of outstanding warrants issued to designees of H.C. Wainwright & Co., LLC (“H.C.W.”)
in the Private Placement as compensation for acting as placement agent (the “Placement Agent Warrants”).
We are filing the registration statement on Form
S-1, of which this prospectus forms a part, to fulfill our contractual obligations with the Selling Stockholders to provide for the resale
by the Selling Stockholders of the shares of Common Stock offered hereby. See “Selling Stockholders” beginning on page 103
of this prospectus for more information about the Selling Stockholders. The registration of the shares of Common Stock to which this prospectus
relates does not require the Selling Stockholders to sell any of their shares of our Common Stock.
We are not offering any shares of Common Stock
under this prospectus and will not receive any proceeds from the sale or other disposition of the shares covered hereby. See “Use
of Proceeds” beginning on page 43 of this prospectus.
The Selling Stockholders identified in this prospectus,
or their pledgees, assignees, donees, transferees or their respective successors-in-interest, from time to time may offer and sell through
public or private transactions at prevailing market prices, at prices related to prevailing market prices or at privately negotiated prices
the shares held by them directly or through underwriters, agents or broker-dealers on terms to be determined at the time of sale, as described
in more detail in this prospectus. See “Plan of Distribution” beginning on page 106
of this prospectus for more information about how the Selling Stockholders may sell their respective shares of Common Stock. The Selling
Stockholders may be deemed “underwriters” within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended.
In connection with the Private Placement, we have
agreed, pursuant to a certain registration rights agreement that we have entered into with the Investor Selling Stockholder, to bear all
of the expenses in connection with the registration of the shares of Common Stock pursuant to this prospectus. The Selling Stockholders
will pay or assume all commissions, discounts, fees of underwriters, selling brokers or dealer managers and similar expenses, if any,
attributable to its sales of the shares of Common Stock.
Our Common Stock is listed on the Nasdaq Capital
Market (“Nasdaq”) under the symbol “CVKD.” On July 21, 2023, the last reported sale price of our Common Stock
was $1.1978 per share.
We are an “emerging growth company”
under the federal securities laws and have elected to comply with certain reduced public company reporting requirements.
Investing
in our Common Stock is involves a high degree of risk. See “Risk Factors” beginning on page 9. Neither the Securities and
Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus
is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is ,
2023
TABLE
OF CONTENTS
ABOUT THIS PROSPECTUS
You should rely only on the information we have
provided or incorporated by reference into this prospectus, any applicable prospectus supplement and any related free writing prospectus.
We have not authorized anyone to provide you with information different from that contained in this prospectus, any applicable prospectus
supplement or any related free writing prospectus. No dealer, salesperson or other person is authorized to give any information or to
represent anything not contained in this prospectus, any applicable prospectus supplement or any related free writing prospectus. You
must not rely on any unauthorized information or representation. This prospectus is an offer to sell only the shares of Common Stock offered
hereby, but only under circumstances and in jurisdictions where it is lawful to do so. You should assume that the information in this
prospectus, any applicable prospectus supplement or any related free writing prospectus is accurate only as of the date on the front of
the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by
reference, regardless of the time of delivery of this prospectus or any sale of a security.
This prospectus includes statistical and other
industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry
publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed
to be reliable, although they do not guarantee the accuracy or completeness of such information. We believe that the data obtained from
these industry publications and third-party research, surveys and studies are reliable. The Company is ultimately responsible for all
disclosure included in this prospectus.
The Selling Stockholders are offering the shares
of Common Stock only in jurisdictions where such issuances are permitted. The distribution of this prospectus and the issuance of the
shares of Common Stock in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of
this prospectus must inform themselves about, and observe any restrictions relating to, the issuance of the Shares and the distribution
of this prospectus outside the United States. This prospectus does not constitute, and may not be used in connection with, an offer to
sell, or a solicitation of an offer to buy, the shares of Common Stock offered by this prospectus by any person in any jurisdiction in
which it is unlawful for such person to make such an offer or solicitation.
This prospectus is part of a registration statement
that we filed with the U.S. Securities and Exchange Commission (the “SEC”), under which the Selling Stockholders may offer
from time-to-time securities described herein in one or more offerings. If required, each time a Selling Stockholder offers shares, we
will provide you with, in addition to this prospectus, a prospectus supplement that will contain specific information about the terms
of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain material information
relating to that offering. We may also use a prospectus supplement and any related free writing prospectus to add, update or change any
of the information contained in this prospectus or in documents we have incorporated by reference. This prospectus, together with any
applicable prospectus supplements, any related free writing prospectuses and the documents incorporated by reference into this prospectus,
includes all material information relating to this offering. To the extent that any statement that we make in a prospectus supplement
is inconsistent with statements made in this prospectus, the statements made in this prospectus will be deemed modified or superseded
by those made in a prospectus supplement. Please carefully read both this prospectus and any prospectus supplement before buying any of
the securities offered.
This prospectus contains summaries of certain
provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information.
All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have
been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a
part, and you may obtain copies of those documents as described below under the section entitled “Where You Can Find Additional
Information.”
This prospectus provides you with a general description
of the shares of Common Stock the Selling Stockholders may offer. A prospectus supplement may also add, update or change information contained
in this prospectus. To the extent that any statement made in an accompanying prospectus supplement is inconsistent with statements made
in this prospectus, the statements made in this prospectus will be deemed modified or superseded by those made in the accompanying prospectus
supplement. You should read both this prospectus and any accompanying prospectus supplement together with the additional information described
under the heading “Where You Can Find More Information” beginning on page 107 of
this prospectus.
Neither we nor any Selling Stockholder has authorized
anyone to provide you with information different from that contained in this prospectus, any accompanying prospectus supplement or in
any related free-writing prospectus filed by us with the SEC. Neither we nor any Selling Stockholder takes any responsibility for, or
provide any assurance as to the reliability of, any information other than the information in this prospectus, any accompanying prospectus
supplement or in any related free-writing prospectus filed by us with the SEC. This prospectus and any accompanying prospectus supplement
do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the securities described in this prospectus
or any accompanying prospectus supplement or an offer to sell or the solicitation of an offer to buy such securities in any circumstances
in which such offer or solicitation is unlawful. You should assume that the information appearing in this prospectus, any prospectus supplement,
the documents incorporated by reference and any related free-writing prospectus is accurate only as of their respective dates. Our business,
financial condition, results of operations and prospects may have changed materially since those dates.
Except as otherwise indicated herein or as the
context otherwise requires, references in this prospectus to “Cadrenal,” “the company,” “we,” “us,”
“our” and similar references refer to Cadrenal Therapeutics, Inc., an entity incorporated under the laws of the State of Delaware.
TRADEMARKS
We own directly, or have rights to, trademarks,
service marks, and trade names that we use in connection with the operation of our business, such as Cadrenal Therapeutics. In addition,
our names, logos, and website names and addresses are our service marks or trademarks. Other trademarks, service marks, and trade names
appearing in this prospectus are the property of their respective owners. Solely for convenience, the trademarks, service marks, trade
names, and copyrights referred to in this prospectus are listed without the ©, ®, and ™ symbols, but we will assert, to
the fullest extent under applicable law, our rights, the rights of our parent company, or the rights of the applicable licensors to these
trademarks, service marks, and trade names.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated
by reference into this prospectus include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,
as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other
factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results,
levels of activity, performance or achievements expressed or implied by these forward-looking statements. Words such as, but not limited
to, “anticipate,” “aim,” “believe,” “contemplate,” “continue,” “could,”
“design,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,”
“predict,” “poise,” “project,” “potential,” “suggest,” “should,”
“strategy,” “target,” “will,” “would,” and similar expressions or phrases, or the negative
of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain
these identifying words. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to
differ materially from those expressed in the forward-looking statements. Accordingly, any such statements are qualified in their entirety
by reference to the information described under the caption “Risk Factors” and elsewhere in this prospectus.
The forward-looking statements contained in this
prospectus are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current
conditions, expected future developments, and other factors we believe are appropriate under the circumstances. As you read and consider
this prospectus, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties
(many of which are beyond our control), and assumptions. Although we believe that these forward-looking statements are based on reasonable
assumptions, you should be aware that many factors could affect our actual operating and financial performance and cause our performance
to differ materially from the performance anticipated in the forward-looking statements. We believe these factors include, but are not
limited to, those described under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition
and Results of Operations.” Should one or more of these risks or uncertainties materialize, or should any of these assumptions prove
incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking
statements.
Further, any forward-looking statement speaks
only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement
contained in this prospectus to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated
or unanticipated events or circumstances. New factors that could cause our business not to develop as we expect emerge from time to time,
and it is not possible for us to predict all of them. Further, we cannot assess the impact of each currently known or new factor on our
results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from
those contained in any forward-looking statements.
Our current product candidate is undergoing clinical
development and have not been approved by the Food and Drug Administration (“FDA”) or the European Commission. These product
candidates have not been, nor may they ever be, approved by any regulatory agency or competent authorities nor marketed anywhere in the
world.
We may not actually achieve the plans, intentions
or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements.
Forward-looking statements should be regarded solely as our current plans, estimates and beliefs. We have included important factors in
the cautionary statements included in this document, particularly in the section entitled “Risk Factors” of this prospectus
that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Moreover,
we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management
to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these
risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements
are qualified in their entirety by this cautionary statement. Our forward-looking statements do not reflect the potential impact of any
future acquisitions, mergers, dispositions, joint ventures or investments we may make. You should read this prospectus and the documents
that we have filed as exhibits to this prospectus and incorporated by reference herein completely and with the understanding that our
actual future results may be materially different from the plans, intentions and expectations disclosed in the forward-looking statements
we make. The forward-looking statements contained in this prospectus are made as of the date of this prospectus and we do not assume any
obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required
by applicable law.
PROSPECTUS SUMMARY
This summary highlights selected
information that is presented in greater detail elsewhere in this prospectus. This summary does not contain all of the information you
should consider before investing in our Common Stock. You should read this entire prospectus carefully, including the sections titled
“Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
and our audited financial statements and the related notes included elsewhere in this prospectus, before making an investment decision.
Unless the context otherwise requires, the terms “Cadrenal,” “the Company,” “we,” “us”
and “our” in this prospectus refer to Cadrenal Therapeutics, Inc.
Overview
We are focused on developing tecarfarin, a novel
therapy with orphan drug indication, designed for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients
with end-stage renal disease, or ESRD, and atrial fibrillation (irregular heartbeat), or AFib. We secured the rights to tecarfarin on
April 1, 2022 via an asset purchase agreement from HESP LLC, a wholly owned subsidiary of Horizon Technology Finance Corporation. HESP
LLC acquired the assets of Espero BioPharma, Inc., or Espero, including tecarfarin, in an assignment for the benefit of creditors in which
the creditor, Horizon Technology Finance Corporation and Horizon Credit II LLC (collectively, Horizon), a secured lender of Espero, designated
HESP LLC as the assignee of Espero’s assets.
Tecarfarin is an anticoagulant (blood thinner)
that uses a drug design process which targets a different pathway than the most commonly prescribed drugs used in the treatment of thrombosis
and AFib. Tecarfarin has been evaluated in eleven (11) human clinical trials conducted by its previous owners and other third parties
in over 1,003 individuals (269 patients were treated for at least six months and 129 patients were treated for one year or more). In Phase
1, Phase 2 and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with
chronic kidney disease, or CKD. In the Phase 2/3 trial, EMBRACE-AC, the largest tecarfarin trial with 607 patients having completed it,
only 1.6% of the blinded tecarfarin subjects suffered from major bleeding and there were no thrombotic events. Five patients died during
the trial, but only one death due to intracerebral hemorrhage was considered to be possibly related to the tecarfarin.
In 2019, the United States Food and Drug Administration,
or FDA, provided input on the Phase 3 trial design for tecarfarin, which was submitted by Espero, the previous owner of tecarfarin. We
intend to submit our Phase 3 trial design to the FDA using the same protocol that was submitted by Espero. Assuming the FDA accepts our
Phase 3 trial design, we intend to commence the Phase 3 pivotal trial in the first half of 2024. However, there can be no assurance that
the trial design will be accepted by the FDA. We are pursuing regulatory approval of tecarfarin as an individual treatment, although we
intend to evaluate, in consultation with the FDA, other potential uses in the future, including the treatment of patients with Left Ventricular
Assist Devices (“LVAD”) and antiphospholipid syndrome (“APS”) who require chronic anticoagulation.
In March 2019, the FDA granted orphan drug designation,
or ODD, for tecarfarin for the prevention of systemic thromboembolism of cardiac origin in patients with ESRD and AFib. The FDA grants
ODD status to drugs that are intended for the treatment, diagnosis, or prevention of rare diseases or conditions, which are defined as
a disease or condition that affects fewer than 200,000 people in the U.S. The ODD program provides a drug developer with certain benefits
and incentives, including a seven-year period of U.S. marketing exclusivity from the date of marketing authorization, waiver of FDA user
fees, and tax credits for clinical research. The granting of an orphan drug designation does not alter the FDA’s regulatory requirements
to establish safety and effectiveness of a drug through adequate and well-controlled studies to support approval and commercialization.
Furthermore, orphan drug designation does not indicate or guarantee FDA approval of the New Drug Application, or NDA, and we might not
receive exclusivity.
Tecarfarin was developed by researchers using
a retrometabolic drug design process which targets a different metabolic pathway than the most commonly prescribed drugs for the treatment
of thrombosis and AFib. “Drug metabolism” refers to the process by which a drug is inactivated by the body and rendered easier
to eliminate or to be cleared by the body. Most approved drugs, including warfarin, the only FDA-approved Vitamin K antagonists, or VKAs,
which is a prescribed drug for the treatment of thrombosis, are metabolized in the liver through a pathway known as the Cytochrome CYP450
system, or CYP450, by the enzymes known as CYP2C9 and CYP3A4. By using a different metabolic pathway, tecarfarin eliminates or minimizes
the CYP450 metabolism in the liver. Patients taking multiple medications that interact with CYP2C9, or CYP3A4 or those with impaired kidney
function, can experience an overload in the pathway, creating a bottleneck that often leads to insufficient clearance, which results in
a toxic build-up of one or more drugs. In some instances, patients taking multiple medications metabolized by the same CYP450 pathway
may experience decreased efficacy of one or more of the medications due to rapid metabolism or increased drug effect and/or toxicity due
to enzyme induction. Patient-specific genetic differences can also hinder drug clearance in the CYP450 pathway. Our product candidate
tecarfarin was designed to follow a metabolic pathway distinct from the CYP450 pathway and is metabolized by both CYP450 and non-CYP450
pathways. We believe this may allow elimination by large capacity and non-saturable tissue esterase pathways that exist throughout the
body rather than just in the liver.
Tecarfarin is an orphan designated, vitamin K
antagonist, oral, once-daily anticoagulant in the same drug class as warfarin designed for use in patients requiring chronic VKA anticoagulation,
to prevent systemic thromboembolism of cardiac origin in patients with ESRD and AFib. The prevailing treatment for thrombosis is with
an oral anticoagulant, either a VKA, like warfarin, or non-vitamin K oral anticoagulant (“NOAC”). VKAs block the production
of vitamin K-dependent blood clotting factors, such that the blood is “thinned,” preventing clots, while NOACs directly block
the activity of certain of these clotting factors. Tecarfarin, like warfarin, is a VKA.
Vitamin K epoxide Reductase Complex subunit 1
(VKORC1) is a significant enzyme for effective clotting. VKORC1 reduces vitamin K epoxide to its active form (Vitamin K), which is the
rate-limiting step in the physiological process of vitamin K recycling. Vitamin K serves as a cofactor for normal function of several
clotting/anticoagulation factors including Factors II, VII, IX and X and Proteins C, S, and Z. VKORC1 genetic deficiencies result in increased
sensitivity to VKAs, which results in an increase in the risk of significant hemorrhaging. We believe tecarfarin has similar potency for
VKORC1 inhibition as warfarin, but it is an investigational new drug, and we must demonstrate it is safe and effective for its proposed
indication.
AFib is the most common arrhythmia, with its incidence
and prevalence increasing over the last 20 years. AFib is associated with an approximate five-fold increased risk of stroke. The risk
of developing AFib increases in patients with CKD. According to 2021 estimates by the Centers for Disease Control and Prevention, or CDC,
approximately 15% of the U.S. adult population, or 37 million people, have CKD. An estimated 0.4% of people in the U.S. suffer from Stage
4 CKD and 0.1% of people in the U.S. have ESRD.
Patients with ESRD and AFib represent a spectrum
of disorders involving both the heart and kidneys (known as cardiorenal syndrome or CRS) in which acute or chronic dysfunction in one
organ may induce acute or chronic dysfunction in the other organ. These patients have typically been excluded from randomized clinical
trials because the approved therapies for AFib have metabolic profiles that may increase drug exposures thereby increasing the known risks
and challenges in managing these patients. The presence of either CKD or AFib, increases the risk of serious thromboembolic adverse clinical
outcomes, such as stroke and death. Antithrombotic therapy is typically recommended to decrease this risk in AFib patients, but there
are no approved treatment options for patients with ESRD and AFib. Warfarin may cause substantial harm in these patients. Low-dose apixaban
(Eliquis) was approved by the FDA for use in ESRD patients on hemodialysis based upon limited pharmacokinetic data by 8 subjects, despite
that randomized trials to date of apixaban versus warfarin for AFib excluded patients with severe and end-stage kidney disease. The RENAL-AF
(Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation) was terminated early in 2019 by its sponsor.
There are more than 809,000 Americans with ESRD,
with approximately 70% on dialysis, according to the United States Renal Data System. Approximately 150,000 ESRD patients also have AFib.
AFib nearly doubles the anticipated mortality and increases the stroke risk by approximately five-fold in these patients. There is evidence
that AFib is an independent risk factor for developing ESRD in CKD patients. Both diseases share common risk factors including hypertension,
diabetes, vascular disease, and advancing age. Cardiovascular disease contributes to more than half of all deaths among patients with
ESRD. According to the Annual Data Report published by the United States Renal Data System, total Medicare spending for patients with
ESRD reached $51 billion in 2019, accounting for approximately 7% of the Medicare paid claims costs.
We have licensed out the rights to tecarfarin
for several Asian markets including China, to Lee’s Pharmaceutical Holdings Limited, an integrated research-driven and market-oriented
biopharmaceutical publicly listed company based in Hong Kong with over 25 years’ experience in the pharmaceutical industry in China.
Lee’s Pharmaceutical Holdings Limited is developing tecarfarin as an anti-thrombotic for patients with mechanical heart valves.
In 2020 and 2021, Lee’s Pharmaceutical Holdings Limited completed two Phase 1 studies in China and Hong Kong and is currently preparing
for its Phase 2 trial.
| * | The
rights to tecarfarin for several Asian markets including China have been out licensed to Lee’s Pharmaceutical, a publicly listed
company based in Hong Kong, who is developing tecarfarin as an anti-thrombotic for patients with mechanical heart valves. |
Members of our management team have extensive
experience in drug discovery, development and commercialization and have held senior leadership positions at a number of pharmaceutical
and biotechnology companies. We also benefit from our broad network of established relationships with leaders in the industry and medical
community.
As more fully set forth in our risk factors, we
are a clinical development biopharmaceutical company with a limited operating history. We have a history of operating losses and expect
to continue to incur substantial losses for the foreseeable future. Our cash and the proceeds from our initial public offering and the
private placement offering that we consummated in July 2023 will only fund our operations for a limited time. The proceeds from our financings
to date are insufficient to allow us to fully fund our planned pivotal Phase 3 clinical trial. We will need to raise additional capital
for the initiation of enrollment of patients and completion of the planned pivotal Phase 3 trial.
With respect to tecarfarin, we have two issued
U.S. patents directed to tecarfarin. While the patents currently expire in 2024, we expect to seek extensions of patent terms. In the
United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years
beyond the normal expiration of the patent, which is limited to the approved indication (or any additional indications approved during
the period of extension). We also intend to seek exclusivity for our proprietary product candidates through market and data exclusivity
granted by regulatory agencies in the United States and other countries. Further, as discussed above, the ODD program provides a drug
developer with certain benefits and incentives, including a seven-year period of U.S. marketing exclusivity from the date of marketing
authorization.
While we have engaged intellectual property counsel
to assist in protecting our patent ownership rights, to date, we have not had intellectual property counsel conduct a freedom to operate
analysis regarding our tecarfarin product. As a result, we cannot be certain that we will not be exposed to third party legal claims,
liabilities and/or litigation actions when we seek to develop, make and market products using our tecarfarin technology.
Clinical Trials
Tecarfarin has been evaluated in 11 human clinical
trials in over 1,003 individuals which includes eight Phase 1 trials, two Phase 2 trials and one Phase 2/3 trial evaluating the efficacy
and safety of tecarfarin.
In a Phase 2/3 randomized and blinded trial sponsored
by ARYx Therapeutics, Inc. in 2008, 607 patients with indications for chronic anticoagulation were treated with either tecarfarin or warfarin.
The Time in Therapeutic Range, or TTR, with tecarfarin was similar to that with well-managed warfarin and tecarfarin appeared to have
a favorable safety profile and be well tolerated with only 1.6% of the blinded tecarfarin subjects suffering from major bleeding and no
thrombotic events. When thrombotic and major bleeding events during the blinded period were combined, a numerical imbalance favoring tecarfarin
over warfarin was seen (warfarin 11 subjects, 3.6%; tecarfarin 5 subjects, 1.6%). The trial however did not meet its primary endpoint
as superiority of tecarfarin over warfarin as measured by TTR was not demonstrated.
In a subsequent Phase 1 study with 23 patients
with CKD sponsored by Armetheon, Inc. in 2016, the metabolism of warfarin was inhibited, but not tecarfarin. The safety of repeated dosing
of tecarfarin in CKD patients remained unknown. However, if the pharmacokinetic findings of this single-dose study are present with repeated
dosing, tecarfarin may lead to dosing that is more predictable than warfarin in CKD patients who require anticoagulation therapy.
Recent Events
Fast Track Designation
On January 13, 2023, the FDA designated as a Fast
Track development program the investigation of tecarfarin for the prevention of systemic thromboembolism of cardiac origin in patients
with ESRD and AFib. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions
and fill an unmet medical need.
Initial Public Offering
On January 24, 2023, we completed our initial
public offering of 1,400,000 shares of our Common Stock at a public offering price of $5.00 per share, generating gross proceeds of $7,000,000.
Our shares of Common Stock commenced trading on the Nasdaq Capital Market (“Nasdaq”) on January 20, 2023 under the symbol
“CVKD.”
In connection with our initial public offering,
on January 19, 2023, we entered into the Underwriting Agreement with the Representative, pursuant to which we issued to the Representative
the Representative’s Warrant to purchase an aggregate of 84,000 shares of our Common Stock, which is equal to six percent (6%) of
the shares of Common Stock sold in the initial public offering. Such Representative’s Warrant has an exercise price of $6.00, which
is equal to 120% of the public offering price of the Common Stock in the initial public offering.
In connection with the closing of the initial
public offering, we entered into separate indemnification agreements with each of our directors (we had previously entered into separate
indemnification agreements with each of our executive officers). The indemnification agreements, in addition to our Amended and Restated
Certificate of Incorporation and Amended and Restated Bylaws, require us to indemnify our directors, executive officers and certain controlling
persons to the fullest extent permitted by Delaware law.
Private Placement
On July 12, 2023, we entered into a securities
purchase agreement (the “Purchase Agreement”) with the Investor Selling Stockholder pursuant to which we sold to the Investor
Selling Stockholder in the Private Placement priced at-the-market consistent with the rules of the Nasdaq Stock Market LLC, (i) an aggregate
of 1,300,000 Shares, (ii) in lieu of additional Shares, the Pre-Funded Warrants to purchase up to an aggregate of 2,985,715 shares of
Common Stock, and (iii) accompanying Common Warrants to purchase up to an aggregate of 4,285,715 shares of Common Stock. The combined
purchase price of each Share and accompanying Common Warrants is $1.75. The combined purchase price of each Pre-Funded Warrant and accompanying
Common Warrants is $1.7499.
The Private Placement closed on July 14, 2023.
We received aggregate gross proceeds from the Private Placement of approximately $7.5 million, before deducting the placement agent commissions
and estimated offering expenses payable by us. We intend to use the net proceeds from the Private Placement for working capital purposes.
H.C.W. acted as the placement agent in the Private Placement and as part of its compensation we issued to designees of H.C.W. Placement
Agent Warrants to purchase up to 278,571 shares of Common Stock.
Appointment of Robert Lisicki To the Board
of Directors
On July 23, 2023, the Board of Directors increased
the size of the Board from four directors to five directors and appointed Robert Lisicki to serve as a Class II director to hold office
until the first annual meeting of stockholders to be held in 2024. Mr. Lisicki was also appointed to serve as a member of the Compensation
Committee of the Board of Directors and the Nominating and Corporate Governance Committee of the Board of Directors.
Our Strategy
Our goal is to build a biopharmaceutical company
with a foundation of product candidates that significantly advance patient care in cardiovascular diseases. Key elements of our strategy
are as follows:
| ● | Complete
the clinical development of and seek FDA approval for tecarfarin. We intend to initiate our pivotal Phase 3 clinical trial in the first
half of 2024, subject to funding from additional financings, which we believe will be our remaining pivotal trial based upon the latest
feedback that the prior owner of tecarfarin had with the FDA in 2019. ACTOR AF: Anti-Coagulation with Tecarfarin on Outcomes in Renal
disease and Atrial Fibrillation is designed as a Phase 3, 492-patient, Randomized, Double-Blind, Placebo-Controlled Outcomes Study of
Tecarfarin vs. Placebo in Subjects with End-Stage Renal Disease and Atrial Fibrillation not Currently Treated with Chronic Oral Anticoagulation.
If we are able to complete the Phase 3 clinical trial and we are able to obtain FDA approval of our NDA, we believe tecarfarin can be
an alternative treatment for patients who are currently without an approved treatment. |
| ● | If
we obtain FDA approval of our NDA for our first indication, we intend to seek to expand the label for tecarfarin through a supplemental
NDA. We intend to explore the full potential of tecarfarin in additional indications, including the treatment of patients with LVADs,
APS and Mechanical Heart Valves (MHVs) who require chronic anticoagulation. An LVAD is an implantable pump attached to the heart, connecting
the apex of the left ventricle to the ascending aorta. LVADs are intended to treat patients suffering from advanced heart failure. APS
is an autoimmune disorder characterized by an increased tendency to form abnormal blood clots, which can form in nearly any blood vessel
in the body, and which can also cause miscarriages in women. MHVs are a type of prosthetic heart valve constructed of durable materials
such as titanium or carbon that can potentially last a patient’s lifetime. Despite their high durability, MHVs are associated with
an increased risk of developing blood clots that may interrupt blood flow and travel to various organs (thromboembolism). Oral anticoagulation
therapy with a vitamin K antagonist (warfarin) continues to be the recommended treatment option for patients implanted with an MHV based
on the 2014 American Heart Association/American College of Cardiology Guidelines. |
| ● | We
intend to partner and/or in-license and/or acquire clinical and pre-clinical stage cardiovascular products to augment our current pipeline
which consists of one investigational product. |
| ● | Create
a commercial infrastructure for our product candidates. If tecarfarin is approved by the FDA, we intend to expand our commercial infrastructure
and hire and train a focused and dedicated specialty cardiorenal salesforce which we believe can efficiently cover the top prescribing
physicians and approximately 3,000 anticoagulation clinics in the U.S., which presently monitor patients on warfarin. If approved, we
intend to initially target our tecarfarin commercialization efforts at the two largest dialysis providers in the U.S., DaVita Kidney
Care and Fresenius Medical Care. DaVita maintains more than 2,800 brick-and-mortar dialysis centers in the U.S., while Fresenius’
North America subsidiary owns more than 2,500 on the continent — together accounting for more than 70% of the entire U.S. market. |
Implications of Being an Emerging
Growth Company and a Smaller Reporting Company
We qualify as an “emerging growth
company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. As an “emerging growth
company,” we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to
public companies. These provisions include, but are not limited to:
| ● | requiring
only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly
reduced “Management’s discussion and analysis of financial condition and results of operations” in our Securities Act
filings; |
| ● | reduced
disclosure about our executive compensation arrangements; |
| ● | no
non-binding advisory votes on executive compensation or golden parachute arrangements; and |
| ● | exemption
from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant
to Section 404(b) of the Sarbanes Oxley Act of 2002, or SOX. |
We may take advantage of these exemptions
for up to five years or such earlier time that we are no longer an “emerging growth company.” We will continue to remain an
“emerging growth company” until the earliest of the following: (i) the last day of the fiscal year following the fifth
anniversary of the date of the completion of our August 2022 IPO; (ii) the last day of the fiscal year in which our total annual
gross revenue is equal to or more than $1.235 billion; (iii) the date on which we have issued more than $1 billion in nonconvertible
debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules
of the SEC.
We are also a “smaller reporting
company” as defined in the Securities Exchange, and have elected to take advantage of certain of the scaled disclosures available
to smaller reporting companies. To the extent that we continue to qualify as a “smaller reporting company” as such term is
defined in Rule 12b-2 under the Exchange Act, after we cease to qualify as an emerging growth company, certain of the exemptions
available to us as an “emerging growth company” may continue to be available to us as a “smaller reporting company,”
including exemption from compliance with the auditor attestation requirements pursuant to SOX and reduced disclosure about our executive
compensation arrangements. We will continue to be a “smaller reporting company” until we have $250 million or more in
public float (based on our Common Stock) measured as of the last business day of our most recently completed second fiscal quarter or,
in the event we have no public float (based on our Common Stock) or a public float (based on our Common Stock) that is less than $700
million, annual revenues of $100 million or more during the most recently completed fiscal year.
We may choose to take advantage of some,
but not all, of these exemptions. We have taken advantage of reduced reporting requirements in this prospectus. Accordingly, the information
contained herein may be different from the information you receive from other public companies in which you hold stock. In addition, the
JOBS Act provides that an emerging growth company may take advantage of an extended transition period for complying with new or revised
accounting standards, delaying the adoption of these accounting standards until they would apply to private companies. We have elected
to avail ourselves of the extended transition period for complying with new or revised financial accounting standards. As a result of
the accounting standards election, we will not be subject to the same implementation timing for new or revised accounting standards as
other public companies that are not emerging growth companies which may make comparison of our financials to those of other public companies
more difficult.
Summary Risk Factors
Our business faces significant risks and uncertainties
of which investors should be aware before making a decision to invest in our Common Stock. If any of the following risks are realized,
our business, financial condition and results of operations could be materially and adversely affected. The following is a summary of
the more significant risks relating to the Company. A more detailed description of our risk factors is set forth below under the caption
“Risk Factors” in this prospectus.
Risks Related to Our Financial Position
and Need for Capital
| ● | We
have a limited operating history, a history of losses and expect to continue to incur losses; |
| ● | Our
cash and the proceeds from our initial public offering and July 2023 private placement offering will only fund our operations for a limited
time; |
| ● | We
will need to raise additional capital. |
Risks Related to Product Development, Regulatory
Approval, Manufacturing and Commercialization
| ● | Our
business is dependent upon the success of tecarfarin, which requires additional clinical testing; |
| ● | All
of our current data for tecarfarin are the results of clinical trials conducted by third parties; |
| ● | Our
development efforts may not generate data sufficient to support regulatory approval; |
| ● | Even
if we complete our clinical trials, we may not receive regulatory approval for tecarfarin; |
| ● | Fast
Track designation and Orphan Drug Designation by the FDA does not assure FDA approval; |
| ● | Even
if we obtain regulatory approval, we may not enjoy marketing exclusivity and we may face development, regulatory or labeling difficulties; |
| ● | Clinical
trials are very expensive, time-consuming and difficult to design and implement. |
| ● | We
may experience delays in the enrollment of patients in any or all of our clinical trials; |
| ● | If
tecarfarin is approved, our success depends on our commercialization efforts and market acceptance; |
| ● | We
have never submitted an NDA to the FDA or comparable applications to other regulatory authorities; |
| ● | After
approval of tecarfarin, it will remain subject to regulatory obligations and other restrictions; |
| ● | We
are subject to federal and state obligations and regulations applicable to our marketing practices; |
| ● | We
currently do not have an agreement with a third-party manufacturer to produce tecarfarin; |
| ● | If
the manufacturer fails to comply with stringent regulations, we may face delays; |
| ● | We
face substantial competition; |
| ● | Serious
adverse effects may be identified with respect to our products, which may harm our business; |
| ● | Recently
enacted and future legislation may affect marketing approval and commercialization of tecarfarin; |
| ● | We
may be subject to penalties if we violate healthcare fraud and abuse laws or price reporting laws; |
| ● | Our
ability to generate product revenues will be diminished if our products sell for inadequate prices; |
| ● | We
will rely on third parties to conduct all of our clinical trials; |
| ● | We
currently have limited distribution, marketing, support and sales capabilities; |
| ● | Our
employees, contractors, consultants, commercial partners and vendors may engage in misconduct; |
| ● | If
we are not successful establishing a sales force, our ability to generate sales and profits will be limited; |
| ● | We
plan to rely on collaborations with third parties to commercialize, market and promote our products; |
| ● | Our
future growth depends, in part, on our ability to penetrate foreign markets; |
| ● | The
ongoing COVID-19 global health crisis may impact our planned operations; |
| ● | Compliance
with regulations regarding the treatment of animals could increase our costs. |
General Company-Related Risks
| ● | Our
business depends upon our ability to attract and keep senior management and key scientific personnel; |
| ● | We
will need to increase the size of our organization, and we may experience difficulties managing this; |
| ● | If
product liability lawsuits are brought against us, we may incur substantial liabilities; |
| ● | Computer
system failures could be costly and expose us to litigation and government enforcement actions; |
| ● | Acquisitions
of other businesses could harm our operating results; |
| ● | Declining
general economic or business conditions may have a negative impact on our business. |
Risks Related to Our Intellectual Property
| ● | We
may be unable to obtain and maintain market exclusivity or patent protection for tecarfarin; |
| ● | To
date, we have not engaged intellectual property counsel to conduct a freedom to operate analysis; |
| ● | We
may become involved in intellectual property lawsuits, which could be costly and time consuming; |
| ● | Patent
law changes in the United States and other jurisdictions could diminish the value of patents; |
| ● | Patent
protection depends on compliance with requirements imposed by governmental patent agencies; |
| ● | We
may not be able to enforce our intellectual property rights throughout the world; |
| ● | Patent
terms may be inadequate to protect our competitive position on our products; |
Risks Related to Ownership of Our Common
Stock
| ● | An
active public trading market for our Common Stock may not develop or be sustained; |
| ● | We
cannot be assured that we will be able to maintain our listing on the Nasdaq Capital Market; |
| ● | Our
stock price has been extremely volatile; |
| ● | If
favorable research or reports about us are not published our stock price could decline; |
| ● | Our
officers, directors, and principal stockholders exercise significant control over our Company; |
| ● | Future
sales of Common Stock could depress the market price of our Common Stock; |
| ● | Our
charter documents have anti-takeover provisions; |
| ● | Claims
for indemnification by our directors and officers may reduce our available funds; |
| ● | We
do not intend to pay dividends in the foreseeable future; |
| ● | Certain
members of our management team have limited experience managing a public company; |
| ● | We
will incur significant increased costs as a result of operating as a public company; and |
| ● | We are an emerging growth company and may avail ourselves
of reduced disclosure requirements or extended transition periods for complying with new or revised accounting standards. |
Risks Related to the Private Placement
and Ownership of the Warrants
| ● | Our management will have broad discretion over the use of
the proceeds to us from the Private Placement and may apply it to uses that do not improve our operating results or the value of our
securities; |
| ● | There is no public market for the Pre-Funded Warrants, Common
Warrants or Placement Agent Warrants; |
| ● | We may not receive any additional funds upon the exercise
of the Pre-Funded Warrants, Common Warrants or Placement Agent Warrants; |
| ● | The Pre-Funded Warrants, Common Warrants and Placement Agent
Warrants are speculative in nature; |
| ● | Holders of the Common Warrants, Pre-Funded Warrants and Placement
Agent Warrants offered hereby will have no rights as common stockholders with respect to the shares our common stock underlying the warrants
until such holders exercise their warrants and acquire our common stock, except as otherwise provided in the Common Warrants, Pre-Funded
Warrants and Placement Agent Warrants; and |
THE OFFERING
Shares
of Common Stock offered by the Selling Stockholders |
|
8,850,001
shares (consisting of 1,300,000 Shares, 2,985,715 shares of our Common Stock issuable upon the exercise of the Pre-Funded Warrants,
4,285,715 shares of our Common Stock issuable upon the exercise of the Common Warrants and 278,571 shares of Common Stock issuable
upon exercise of the Placement Agent Warrants. |
|
|
|
Use of proceeds |
|
The Selling Stockholders will receive all of the proceeds of the sale of shares of Common Stock offered from time to time pursuant to this prospectus. Accordingly, we will not receive any proceeds from the sale of shares of Common Stock that may be sold from time to time pursuant to this prospectus; however, we will receive proceeds from the any cash exercise of the Pre-Funded Warrants, Common Warrants and Placement Agent Warrants. See “Use of Proceeds.” We intend to use the proceeds from the any cash exercise of the Pre-Funded Warrants, Common Warrants and the Placement Agent Warrants for working capital purposes |
|
|
|
Risk Factors |
|
See “Risk Factors” beginning on page 9 and
the other information included in this prospectus for a discussion of factors you should carefully consider before investing in our securities. |
|
|
|
Nasdaq Capital Market trading symbol |
|
Our Common Stock is listed on the Nasdaq Capital Market under the symbol “CVKD.” |
| (1) | The number of shares of our Common Stock to be outstanding after this
offering is based on the 13,022,754 shares of our Common Stock outstanding as of July 24, 2023 including 1,300,000 Shares sold in the
Private Placement and excludes the following: |
|
● |
1,175,000 shares of Common Stock issuable upon the exercise of options to purchase shares of Common Stock outstanding as of July 24, 2023, with a weighted-average exercise price of $0.86 per share; |
|
● |
110,500 shares of Common Stock issuable upon the exercise of warrants to purchase shares of Common Stock outstanding as of July 24, 2023, with a weighted-average exercise price of $5.01 per share; |
| ● | 7,550,001
shares of Common Stock issuable upon exercise of the Common Warrants, the Pre-Funded Warrants and the Placement Agent Warrants; and |
|
● |
685,000 shares of Common Stock reserved for future issuance under our 2022 Stock
Incentive Plan. |
RISK FACTORS
Investing in our Common Stock involves a high
degree of risk. You should carefully consider the risks described below, as well as the other information in this prospectus, including
our financial statements and the related notes and the section titled “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” in this prospectus, before deciding whether to invest in our Common Stock. The occurrence of any of the
events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such
an event, the market price of our Common Stock could decline and you may lose all or part of your investment. Additional risks and uncertainties
not presently known to us or that we currently deem immaterial also may impair our business operations.
Risks Related to Our Financial Position and
Need for Capital
We are a clinical development biopharmaceutical
company with a limited operating history.
We are a recently formed company and have had
limited operations to date. We have to complete clinical trials and receive regulatory approval of new drug applications, or NDAs, before
commercial sales of our product candidates can commence. The likelihood of success of our business plan must be considered in light of
the problems, substantial expenses, difficulties, complications and delays frequently encountered in connection with building and expanding
clinical development pharmaceutical businesses and the regulatory and competitive environment in which we operate. Pharmaceutical product
development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive business.
Accordingly, you should consider our prospects
in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the later stage of development, especially
clinical pharmaceutical companies such as ours. Potential investors should carefully consider the risks and uncertainties that a company
with a limited operating history will face. In particular, potential investors should consider that we cannot assure you that we will
be able to:
| ● | successfully
complete the clinical trials necessary to obtain regulatory approval for the marketing of our product candidate, tecarfarin; |
| ● | secure
acceptance of our product candidate in the medical community and with third-party payors and consumers; |
| ● | if
approved for commercial sale, launch commercial sales of our product candidate, whether alone or in collaboration with others; |
| ● | successfully
build an internal sales force meeting our requirements for the marketing and sale of our product candidate, tecarfarin; |
| ● | successfully
manufacture our clinical product and establish commercial drug supply; |
| ● | secure
market exclusivity and/or adequate intellectual property protection for our product candidate; |
| ● | attract
and retain an experienced management, board and scientific advisory team; |
| ● | successfully
implement or execute our current business plan, and we cannot assure you that our business plan is sound; and |
| ● | raise
sufficient funds in the capital markets to effectuate our business plan. |
If we cannot successfully execute any one of the
foregoing, our business may not succeed and your investment will be adversely affected.
We have a limited operating history upon
which to evaluate our ability to commercialize our product candidate.
We are a development-stage company and our success
is dependent upon our ability to obtain regulatory approval for and commercialize our product candidate, tecarfarin, and we have not demonstrated
an ability to perform the functions necessary for the approval or successful commercialization of any product candidate. We have yet to
demonstrate our ability to overcome the risks frequently encountered in our industry and are still subject to many of the risks common
to such enterprises, including our ability to implement our business plan, market acceptance of our proposed business and lead product,
under-capitalization, cash shortages, limitations with respect to personnel, financing and other resources, competition from better funded
and experienced companies, and uncertainty of our ability to generate revenues. In fact, though individual team members have experience
running clinical trials and our Chief Executive Officer has been involved with the development of tecarfarin for five years, as a company
we have yet to prove that we can successfully run a clinical trial. There is no assurance that our activities will be successful or will
result in any revenues or profit, and the likelihood of our success must be considered in light of the stage of our development. In addition,
no assurance can be given that we will be able to consummate our business strategy and plans, or that financial, technological, market,
or other limitations may force us to modify, alter, significantly delay, or significantly impede the implementation of such plans. We
have insufficient results for investors to use to identify historical trends. Investors should consider our prospects in light of the
risk, expenses and difficulties we will encounter as an early stage company. Our revenue and income potential is unproven and our business
model is continually evolving. We are subject to the risks inherent to the operation of a new business enterprise, and cannot assure you
that we will be able to successfully address these risks.
We have a history of operating losses and
expect to continue to incur substantial losses for the foreseeable future. We may never become profitable or, if achieved, be able to
sustain profitability.
To date, we have not generated any revenue from
operations and we expect to continue to incur significant operating losses in connection with the development and sale of tecarfarin.
We may continue to incur operating losses until such time, if ever, as we are able to achieve sufficient levels of revenue from operations.
Our ability to achieve profitability will depend on regulatory approval of our product candidate and if approved, the market acceptance
of our product offering and our capacity to develop, introduce and sell our product to our targeted markets. There can be no assurance
that we will ever generate significant sales or achieve profitability. Accordingly, the extent of future losses and the time required
to achieve profitability, if ever, cannot be predicted at this point.
Even if we succeed in developing and commercializing
one or more product candidates, we expect to incur substantial losses for the foreseeable future and may never become profitable. We also
expect to continue to incur significant operating and capital expenditures and anticipate that our expenses will increase substantially
in the foreseeable future as we:
| ● | continue
to undertake the pivotal clinical trial for our product candidate; |
| ● | seek
regulatory approvals for our product candidate; |
| ● | implement
additional internal systems and infrastructure; and |
| ● | hire
additional personnel. |
We may not be able to generate revenue or achieve
profitability in the future. Our failure to achieve or maintain profitability would likely negatively impact the value of our securities
and could prevent us from continuing as a going concern.
Even if we can secure such arrangements, we may
continue to have obligations and expenses that exceed the revenue generated by these marketed products. In addition, we could incur significant
development and other expenses if we were to make alterations to the manufacturing process for tecarfarin, for preparation and submission
of a supplemental NDA for such alterations, if required by the FDA, and in connection with the launch of tecarfarin, if approved. Further,
as we pursue FDA approval for tecarfarin, we expect that our research and development expenses will continue to increase significantly
as we advance our pivotal Phase 3 clinical trial.
Our cash and the proceeds of our initial
public offering and the private placement offering that we consummated in July 2023 will only fund our operations for a limited time,
and we will need to raise additional capital to fund our planned pivotal Phase 3 clinical trial and to support our development and commercialization
efforts for our product candidate, tecarfarin.
If we do not succeed in raising additional funds
on acceptable terms, we will be unable to commence our planned Phase 3 pivotal clinical trial or obtain approval of our product candidate
from the FDA and other regulatory authorities. In addition, we could be forced to delay, discontinue or curtail product development, forego
sales and marketing efforts, and forego licensing in attractive business opportunities. We estimate that we will require a total of $45
million for the completion of our planned pivotal Phase 3 clinical trial and other expenditures that we will need to incur in order to
file our NDA.
We will also need to raise additional capital
to expand our business to meet our long-term business objectives.
We believe that our existing cash, which includes
the net proceeds from our initial public offering and the private placement offering that we consummated in July 2023, will be sufficient
in the aggregate to meet our anticipated cash requirements for at least the next twelve months. We will, however, require additional financing
as we continue to execute our business strategy, including that we will require additional funds for the initiation of enrollment of patients
and completion of the planned pivotal Phase 3 trial. Our liquidity may be negatively impacted as a result of a research and development
cost increases in addition to general economic and industry factors. We anticipate that, to the extent that we require additional liquidity,
it will be funded through the incurrence of other indebtedness, additional equity financings or a combination of these potential sources
of liquidity. In addition, we may raise additional funds to finance future cash needs through grant funding and/or corporate collaboration
and licensing arrangements. If we raise additional funds by issuing equity securities or convertible debt, our stockholders will experience
dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants
limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring
dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish
valuable rights to our products, future revenue streams or product candidates or to grant licenses on terms that may not be favorable
to us. The covenants under future credit facilities may limit our ability to obtain additional debt financing. We cannot be certain that
additional funding will be available on acceptable terms, or at all. Any failure to raise capital in the future could have a negative
impact on our financial condition and our ability to pursue our business strategies.
Our present and future capital requirements will
depend on many factors, including:
| ● | the
outcome, timing and cost of our Phase 3 clinical trial to obtain regulatory approval for tecarfarin in the United States; |
| ● | the
degree and rate of market adoption of our products, if approved; |
| ● | the
emergence of new, competing technologies and products; |
| ● | the
costs of R&D activities we undertake to develop new products and indications; |
| ● | the
costs of commercialization activities, including sales, marketing and manufacturing; |
| ● | the
costs of building an internal sales force meeting our requirements for the marketing and sale of our product candidates, if approved; |
| ● | our
ability to collaborate with third parties on the development and commercialization of our product candidates and products; |
| ● | the
level of working capital required to support our growth; and |
| ● | our
need for additional personnel, information technology or other operating infrastructure to support our growth and operations as a public
company. |
We do not currently have any arrangements or credit
facilities in place as a source of funds, and there can be no assurance that we will be able to raise sufficient additional capital on
acceptable terms, or at all. We anticipate that the additional funding we require will be funded through the incurrence of other indebtedness,
additional equity financings or a combination of these potential sources of liquidity We may seek additional capital through a combination
of private and public equity offerings, debt financings and strategic collaborations. Debt financing, if obtained, may involve agreements
that include covenants limiting or restricting our ability to take specific actions, including issuing shares of our Common Stock or other
securities and incurring additional debt, and could increase our expenses and require that our assets secure such debt. Equity financing,
if obtained, could result in dilution to our then existing stockholders and/or require such stockholders to waive certain rights and preferences.
If such financing is not available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate
the development of business opportunities and our operations and financial condition may be materially adversely affected. We can provide
no assurances that any additional sources of financing will be available to us on favorable terms, if at all. In addition, if we are unable
to secure sufficient capital to fund our operations, we might have to enter into strategic collaborations that could require us to share
commercial rights to our products or product candidates with third parties in ways that we currently do not intend or on terms that may
not be favorable to us. If we choose to pursue additional indications and/or geographies for any of our products or product candidates
or otherwise expand more rapidly than we presently anticipate, we may also need to raise additional capital sooner than expected.
Risks Related to Product Development, Regulatory
Approval, Manufacturing and Commercialization
Our business is dependent upon the success
of our investigational product candidate, tecarfarin, which requires additional clinical testing before we can seek regulatory approval
and potentially launch commercial sales. We do not own any other product candidates or have any other products in clinical development.
Our business and future success depends upon our
ability to obtain regulatory approval of and then successfully commercialize our product candidate, tecarfarin. Tecarfarin is in late
clinical stage development. Our main focus and the investment of a significant portion of our efforts and financial resources is expected
to be in the development of our only product candidate, tecarfarin, for which we are currently planning a Phase 3 clinical trial with
approximately 492 patients in the United States. We believe that the proceeds from our initial public offering and the private placement
offering that we consummated in July 2023 will not provide us with sufficient funds to initiate or complete this pivotal Phase 3 clinical
trial. Even though we are pursuing a registration pathway based on specific FDA input and guidance, there are many uncertainties known
and unknown that may affect the outcome of the trial. These include adequate patient enrollment, adequate supply of our product candidate,
potential changes in the regulatory landscape, the results of the trial being successful, and FDA acceptance of the data to support approval.
We also rely on third parties to conduct the appropriate clinical trials, and their failure to perform in accordance with applicable law
would have a negative effect on our regulatory submission.
Our future success depends heavily on our ability
to successfully manufacture, develop, obtain regulatory approval, and commercialize tecarfarin, which may never occur. We currently generate
no revenues from our product candidate, and we may never be able to develop or commercialize a marketable drug.
All of our current data for our product
candidate are the results of clinical trials conducted by third parties and do not necessarily provide sufficient evidence that our products
are viable as potential pharmaceutical products.
We possess toxicology, pharmacokinetic, and other
preclinical data and clinical data on tecarfarin from studies and trials conducted several years ago by third parties. As of now, tecarfarin
has been tested in eleven clinical trials and is now in preparations to enter a pivotal Phase 3 trial. There is no guarantee that Phase
1 or Phase 2 results can or will be replicated by the pivotal Phase 3 study. Further, as the clinical trials were conducted by third parties,
and were completed prior to our ownership of the technology, we cannot be assured that such trials were conducted in compliance with applicable
statutes, rules, regulations and guidelines applicable to such trials. Although the FDA concurred with our recommended endpoints in correspondence
that it had with Espero in 2019, and Espero submitted the protocol we plan to use to FDA in 2019, we have not received FDA input on our
Phase 3 protocol. The FDA agreed in principle that “a single registration trial that combines these populations may be acceptable.”
However, there can be no assurance that the planned protocol will be accepted by FDA.
Previous clinical trials using tecarfarin have
had different trial designs, doses, parameters and endpoints than the planned Phase 3 clinical trial that is expected to serve as a basis
for approval of tecarfarin. We plan to use a fixed dose in future clinical trials that we believe provides good coverage given the dose
ranges tested clinically; however, it is possible that the dose selected will not be the optimal dose and so drug effects may be limited
or not be demonstrated sufficiently in clinical testing.
As all of our clinical trials to date were
conducted by third parties, we cannot be assured that such clinical trials were in compliance with applicable laws, rules and regulations.
We did not acquire tecarfarin until April of 2022,
and do not have first-hand knowledge of how the Phase 1 and Phase 2 clinical trials were completed. As such, we cannot be assured that
such clinical trials were conducted in full compliance with applicable laws, rules and regulations. While we are not aware of any issues
in relation to such trials and the performance thereof, we cannot be assured that we may learn in the future that there was a failure
to abide by such laws, rules and regulations, which could potentially expose us to issues with regards to our Phase 3 clinical trials
or otherwise create risks unknown to us with regards to our technology.
Our efforts to develop our product candidate
may not generate data sufficient to support an application for regulatory approval.
Despite the global burden of cardiovascular disease,
investment in cardiovascular drug development has stagnated over the past two decades, with relative underinvestment compared with other
therapeutic areas. The reasons for this trend are multifactorial, but of primary concern is the high cost of conducting cardiovascular
outcome trials in the current regulatory environment that demands a direct assessment of risks and benefits, using clinically meaningful
cardiovascular endpoints. In addition, clinical trials are difficult to design and implement, can take many years to complete and are
uncertain as to outcome. Success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be
successful, and interim results of a clinical trial do not necessarily predict final results. For example, in the Phase 2/3 EMBRACE-AC
trial of tecarfarin conducted by ARYx Therapeutics, Inc., a predecessor company to Espero, tecarfarin did not reach statistical significance
on its primary endpoint, superiority to warfarin as measured by time in TTR. There is no guarantee that later trials, including ACTOR
AF, will reach statistical significance on their endpoints, or demonstrate superiority to warfarin or any other therapy. A failure of
one or more of clinical trials can occur at any stage of testing. Our product candidate may prove to have undesirable or unintended side
effects, toxicities or other characteristics that may preclude our obtaining regulatory approval or prevent or limit commercial use with
respect to one or all intended indications. In addition, we may experience other numerous unforeseen events during, or as a result of,
the clinical trial process that could delay or prevent our ability to continue development. Development stage risks include the following:
| ● | although
we have FDA minutes documenting Espero’s correspondence with the FDA regarding tecarfarin, the FDA minutes are from 2019, are not
binding on FDA, and our expectations regarding such plans may be out of date and not be in line with current market dynamics and the
FDA or comparable foreign regulatory authorities or institutional review boards, or IRBs, may disagree with the design or implementation
of our clinical trial and refuse to let them proceed; |
| ● | we
may not be able to provide acceptable evidence of the safety and efficacy of our product candidates or an acceptable benefit/risk profile
for our product candidate; |
| ● | we
may not be able to successfully manufacture drug supplies for our clinical trial; |
| ● | the
results of our clinical trial may not be satisfactory or may not meet the level of statistical or clinical significance required by the
FDA, European Medicines Agency, or EMA, or other comparable foreign regulatory authorities to demonstrate effectiveness; |
| ● | we
may not be able to determine the optimal dosing of our product candidates; and |
| ● | patients
in our clinical trial may suffer adverse effects that are deemed related to our product candidates, leading us or regulatory authorities
to stop clinical trial temporarily or permanently. |
If unacceptable safety concerns or other adverse
events arise in the development of a product candidate, our clinical trials could be suspended or terminated or the FDA or comparable
foreign regulatory authorities could order us to cease clinical trials or deny approval of such product candidate for any or all targeted
indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the
trial or result in potential product liability claims. Inadequate training in recognizing or managing the potential side effects of a
product candidate could result in patient deaths. Any of these occurrences may harm our business, financial condition and prospects significantly.
Even if we successfully complete our clinical
trials, we may not receive regulatory approval for tecarfarin, and we may not be able to commercialize our product candidate and our ability
to generate revenue will be limited.
The research, testing, manufacturing, labeling,
packaging, storage, approval, sale, marketing, advertising and promotion, pricing, export, import and distribution of drug products are
subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, which regulations
differ from country to country. We are not permitted to market our product candidate in the United States until we receive approval of
an NDA from the FDA and in non-U.S. markets until we receive the requisite approval from comparable regulatory agencies in such countries.
Of the large number of drugs in development, only a small number are submitted for approval to the FDA through an NDA and even fewer are
eventually approved for commercialization. In 2020 and 2021, the FDA approved only three new molecular entities to treat cardiovascular/vascular
diseases. We may not succeed at gaining regulatory approval, which would materially harm our business.
Receipt of necessary regulatory approval is subject
to a number of risks, including the following:
| ● | the
data collected from pre-clinical and clinical trials may not be sufficient to support the submission of an NDA or other submission or
to obtain regulatory approval in the United States or elsewhere; |
| ● | the
FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers
with which we contract for clinical and commercial supplies; and |
| ● | the
relevant laws, approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a
manner rendering our clinical data insufficient for approval. |
We cannot guarantee that regulators will agree
with our assessment of the results of our clinical trials or that such trials will be considered by regulators to have shown safety or
efficacy of our product candidates. For example, while we currently intend to conduct future clinical trials of tecarfarin with a primary
endpoint of reduction of major cardiac adverse events (MACE), we cannot assure you that the FDA will consider it to be a clinically meaningful
endpoint. The FDA, EMA and other regulators have substantial discretion in the approval process and may refuse to accept any application
or may decide that our data are insufficient for approval and require additional clinical trials, or pre-clinical or other trials. In
addition, varying interpretations of the data obtained from pre-clinical and clinical testing could delay, limit or prevent regulatory
approval of a product candidate. Failure to obtain regulatory marketing approval for our product candidates in any indication will prevent
us from commercializing the product candidate, and our ability to generate revenue will be materially impaired.
The process of obtaining regulatory approvals
is expensive, often takes many years, if approval is obtained at all, and can vary substantially based upon, among other things, the type,
complexity and novelty of the product candidates involved, the jurisdiction in which regulatory approval is sought and the substantial
discretion of the regulatory authorities. Changes in regulatory review for a submitted product application may cause delays in approval
or rejection of an application. Regulatory approval obtained in one jurisdiction does not necessarily mean that a product candidate will
receive regulatory approval in all jurisdictions in which we may seek approval, but the failure to obtain approval in one jurisdiction
may negatively impact our ability to seek or gain approval in a different jurisdiction. Obtaining foreign regulatory approvals and compliance
with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the
introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or
fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential
of tecarfarin or any future product candidates will be harmed.
Fast Track designation by the FDA may not
actually lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidate.
If a product candidate is intended for the treatment
of a serious or life-threatening condition and the product candidate demonstrates the potential to address unmet medical need for this
condition, the sponsor may apply for FDA Fast Track designation. However, a Fast Track designation does not ensure that the product candidate
will receive marketing approval or that approval will be granted within any particular timeframe. As a result, while we have received
Fast Track designation for tecarfarin for the prevention of systemic thromboembolism of cardiac origin in patients with ESRD and AFib,
we may not experience a faster development process, review or approval compared to conventional FDA procedures. In addition, the FDA may
withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program.
Fast Track designation alone does not guarantee qualification for the FDA’s priority review procedures.
Even if we obtain regulatory approval, we
will still face ongoing regulatory requirements and tecarfarin may face future development and regulatory difficulties.
Even if we receive regulatory approval of tecarfarin
or any future product candidates, we will be subject to ongoing regulatory obligations, such as post market surveillance and current good
manufacturing practice (“GMP”) requirements, and continued regulatory review, which may result in significant additional expense.
We may also be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with product
candidates. In addition, third parties on whom we rely must comply with regulatory requirements, and any non-compliance on their part
may negatively impact our business, assuming we obtain regulatory authorization at all.
Any regulatory approvals that we receive for product
candidates will require surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a Risk Evaluation
and Mitigation Strategy (“REMS”) program in order to approve product candidates, which could entail requirements for a medication
guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries
and other risk minimization tools. The FDA could also require a boxed warning, sometimes referred to as a Black Box Warning on the product
label to identify a particular safety risk, which could affect commercial efforts to promote and sell the product. In addition, if the
FDA or a comparable foreign regulatory authority approves product candidates, the manufacturing processes, labeling, packaging, distribution,
adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for product candidates will be subject to extensive
and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports,
registration, as well as continued compliance with current GMPs and current good clinical practices (“GCPs”) for any clinical
trials that we conduct post-approval. We are also subject to certain user fees imposed by the regulatory agencies. Later discovery of
previously unknown problems with product candidates, including adverse events of unanticipated severity or frequency, or with our third-party
manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:
| ● | import
alerts or automatic detentions; |
| ● | restrictions
on the marketing or manufacturing of product candidates, withdrawal of the product from the market, or product recalls; |
| ● | fines,
warning letters or holds on clinical trials; |
| ● | refusal
by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of approvals; |
| ● | product
seizure or detention, or refusal to permit the import or export of product candidates; |
| ● | injunctions
or the imposition of civil or criminal penalties; and |
| ● | inability
to obtain government contracts. |
The FDA’s and other regulatory authorities’
policies may change, such as those required by the 21st Century Cures Act, and additional government regulations may be enacted
that could prevent, limit or delay regulatory approval of tecarfarin or any future product candidates. In addition, it is unclear what
changes, if any, the new presidential administration may bring. We cannot predict the likelihood, nature or extent of government regulation
that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt
to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance,
we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.
Clinical trials are very expensive, time-consuming
and difficult to design and implement.
As part of the regulatory process, we must conduct
clinical trials for each product candidate to demonstrate safety and efficacy to the satisfaction of the FDA and other regulatory authorities.
As we advance tecarfarin or any future product candidates we expect that our expenses will increase. The number and design of the clinical
trials that will be required varies depending upon product candidate, the condition being evaluated, current medical strategies and the
trial results themselves. Therefore, it is difficult to accurately estimate the cost of the clinical trials. Clinical trials are very
expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial
process is also time consuming. We estimate that clinical trials of product candidates including tecarfarin, will take at least several
years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon
or repeat clinical trials. The commencement and completion of clinical trials may be delayed or prevented by several factors, including:
| ● | unforeseen
safety issues; |
| ● | failure
to determine appropriate dosing; |
| ● | greater
than anticipated cost of our clinical trials; |
| ● | failure
to demonstrate effectiveness during clinical trials; |
| ● | slower
than expected rates of subject recruitment or difficulty obtaining investigators, particularly during COVID-19; |
| ● | subject
drop-out or discontinuation; |
| ● | import
delays of clinical trial materials; |
| ● | inability
to monitor subjects adequately during or after treatment; |
| ● | third
party contractors, including, without limitation, CROs and manufacturers, failing to comply with regulatory requirements or meet their
contractual obligations to us in a timely manner |
| ● | reaching
agreements with prospective CROs, and trial sites, both of which can be subject to extensive negotiation and may vary significantly among
different CROs and trial sites; |
| ● | insufficient
or inadequate supply or quality of product candidates or other necessary materials to conduct our trials; |
| ● | potential
additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory authorities regarding the scope or
design of our clinical trials, or other studies requested by regulatory agencies; |
| ● | problems
engaging Institutional Review Boards (“IRBs”), to oversee trials or in obtaining and maintaining IRB approval of studies; |
| ● | imposition
of clinical hold or suspension of our clinical trials by regulatory authorities; and |
| ● | inability
or unwillingness of medical investigators to follow our clinical protocols. |
In addition, we or the FDA may suspend or terminate
our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies
in our Investigational New Drug, or IND, submissions or the conduct of these trials. Therefore, we cannot predict with any certainty when,
if ever, future clinical trials will commence or be completed.
Delays in the enrollment of patients in
any or all of our clinical trials could increase our development costs and delay completion of our clinical trials and associated regulatory
submissions.
We may not be able to initiate or continue clinical
trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these
trials as required by the FDA or other regulatory authorities. COVID-19 will likely make this even more challenging. Even if we are able
to enroll a sufficient number of patients in our clinical trials, if the pace of enrollment is slower than we expect, the development
costs for our product candidates may increase, and the completion of our trials may be delayed or our trials could become too expensive
to complete.
Even if approved, tecarfarin may not have
labeling that allows us to successfully commercialize it.
The commercial success of tecarfarin and any of
our future product candidates will depend in significant measure upon our ability to obtain approval from the FDA and other regulatory
authorities of labeling describing a product candidate’s expected features or benefits. Regulatory authorities may approve tecarfarin
for fewer or more limited indications than we request or may approve tecarfarin with labeling that does not include the labeling claims
necessary or desirable for the successful commercialization of that indication. Failure to achieve approval from the FDA or other regulatory
authorities of product labeling containing certain types of information on features or benefits of our products will prevent or substantially
limit our advertising and promotion of such features in order to differentiate our product candidates or any future product candidates
from those products already existing in the market. This may make it difficult or impossible to achieve commercial success.
If our product candidate is approved, our
success depends on our commercialization efforts, which may not be achieved. If we are unable to commercialize our product candidate,
or experience significant delays in doing so, our business could be materially harmed.
We will invest a significant portion of our efforts
and financial resources into the development and commercialization of tecarfarin. Product revenues from our product candidate, tecarfarin,
which will not be realized until after regulatory approval, if ever, will depend on the successful development, regulatory approval and
eventual commercialization of these product candidates. The success of our product candidate will depend on several factors, including
the following:
| ● | receipt
of marketing approvals for our product candidate from the FDA and similar regulatory authorities outside the United States; |
| ● | obtaining
product indications, other labeling information and product attributes that are acceptable and attractive to the medical community, third-party
payors and patients; |
| ● | our
ability to manufacture product commercially at acceptable costs; |
| ● | establishing
and maintaining commercial manufacturing arrangements with third parties; |
| ● | successfully
commercializing our product candidate, if approved, whether alone or in collaboration with others; |
| ● | a
continued acceptable safety profile of the product candidate following approval; and |
| ● | obtaining,
maintaining, enforcing and defending intellectual property rights and claims and available product exclusivities. |
If we do not achieve one or more of these factors
in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidate,
which would materially harm our business. In addition, even if we obtain regulatory approvals for tecarfarin, the timing or scope of any
approval may prohibit or reduce our ability to commercialize tecarfarin successfully. For example, if the approval process takes too long,
we may miss market opportunities and give other companies the ability to develop competing products or establish market dominance. Also,
any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render tecarfarin
not commercially viable. For example, regulatory authorities may grant approval contingent on the performance of costly post-marketing
clinical trials or, outside the U.S., they may not accept or approve the price we intend to charge for tecarfarin. Further, the FDA or
comparable foreign regulatory authorities may place conditions on approvals, such as risk management plans and Risk Evaluation and Mitigation
Strategies, or REMS, to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed
REMS; the FDA will not approve the NDA without an approved REMS, if required. A REMS could include medication guides, physician communication
plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.
The FDA may also require a REMS for an approved product when new safety information emerges. Any of these limitations on approval or marketing
could restrict the commercial promotion, distribution, prescription or dispensing of tecarfarin. Moreover, product approvals may be withdrawn
for non-compliance with regulatory standards or if problems occur following the initial marketing of the product. Any of the foregoing
scenarios could materially harm the commercial success of tecarfarin.
Our potential future product candidate,
tecarfarin, may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community
necessary for commercial success.
The commercial success of any potential future
product candidates, including tecarfarin, for which we may obtain marketing approval from the FDA or other regulatory authorities will
depend upon their acceptance by the medical community and third-party payors as clinically useful, cost-effective and safe. The degree
of market acceptance of any drug depends on a number of factors, such as:
| ● | effectively
competing with other therapies; |
| ● | the
prevalence and severity of any side effects; |
| ● | success
of patients in well-controlled clinical trials compared to real-world success of patients post FDA approval; |
| ● | our
ability to educate and increase physician awareness of the benefits of our products relative to competing drugs; |
| ● | the
willingness of physicians and healthcare organizations to change their current treatment practices, especially with respect to warfarin,
a drug that is dominant in the market and with which physicians and healthcare organizations have 60 years of familiarity; |
| ● | the
willingness of hospitals and hospital systems to include our product candidates as treatment options; |
| ● | efficacy
and potential advantages compared to alternative treatments; |
| ● | the
price we charge for our product candidates; |
| ● | interpretations
of the results of our clinical trials; |
| ● | the
status of our products on the formularies of third-party payers; |
| ● | convenience
and ease of administration compared to alternative treatments; |
| ● | the
willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
| ● | the
willingness of the target patient population to pay for our products, including co-pays under their health coverage plans; |
|
● |
the accuracy of the international normalized ratio, or INR, testing and whether such testing can be conducted at home or in a medical facility such as a doctor’s office. A prothrombin time, or PT, is a test used to help detect and diagnose a bleeding disorder or excessive clotting disorder; the INR is calculated from a PT result and is used to monitor how well an anticoagulant medication such as tecarfarin is working to prevent thrombosis; |
| ● | the
strength of marketing and distribution support; and |
| ● | the
availability of third-party coverage and adequate reimbursement. |
The failure to attain market acceptance among
the medical community, patients and third-party payors may have an adverse impact on our operations and profitability.
We have never submitted an NDA to the FDA
or comparable applications to other regulatory authorities and we may not be successful in achieving approval of our product candidates.
We have never submitted an NDA to the FDA or comparable
applications to other regulatory authorities and expect to rely on consultants and third-party contract research organizations, or CROs,
with expertise in this area to assist us in this process. Securing FDA approval requires the submission of pre-clinical, clinical and/or
pharmacokinetic data, information about product manufacturing processes and inspection of facilities and supporting information to the
FDA for each therapeutic indication to establish a product candidate’s safety and efficacy for each indication. Regulatory authorities
in other jurisdictions impose similar requirements. If we are unable to successfully complete the approval process with the FDA or comparable
applications of other regulatory authorities, our business will not be successful.
Orphan Drug Designation does not translate
to approval and, even if we obtain FDA approval, we may not enjoy marketing exclusivity or other expected benefits.
Although we have been granted orphan drug designation
for tecarfarin, this does not mean FDA will approve the NDA. Even if we obtain FDA approval, we may not be able to obtain or maintain
orphan drug exclusivity for tecarfarin. We may not be the first to obtain marketing approval of tecarfarin designation for the orphan-designated
indication due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the
United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the
FDA later determines that the request for designation was materially defective or if we are unable to assure sufficient quantities of
the product to meet the needs of patients with the rare disease or condition. Further, even if we obtain orphan drug exclusivity for a
product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties
may be approved for the same condition, or the competitive product is otherwise outside the scope of exclusivity. Even after an orphan
drug is approved, the FDA can subsequently approve the same drug with the same active moiety for the same condition if the FDA concludes
that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care
or the manufacturer of the product with orphan exclusivity is unable to maintain sufficient product quantity. Orphan drug designation
neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or
approval process, nor does it prevent competitors from obtaining approval of the same product candidate for indications other than those
in which orphan drug designation have been granted.
After approval of tecarfarin, tecarfarin
will remain subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional risk
and expense.
Drug products remain subject to the jurisdiction
of the FDA and non-U.S. regulatory authorities after they have been approved. Even if we obtain regulatory approval of tecarfarin, the
FDA and other regulatory authorities may impose significant restrictions on its indicated uses or marketing or the conditions of approval,
or impose ongoing requirements for potentially costly and time-consuming post-approval trials, including Phase 4 clinical trials, and
post-market surveillance to monitor safety and efficacy. Our product candidate, if approved, as well as our marketed products are subject
to ongoing regulatory requirements governing the manufacturing, labeling, packaging, storage, distribution, safety surveillance, advertising,
promotion, sampling, recordkeeping and reporting of adverse events and other post-market information. These requirements include registration
with the FDA and continued compliance with current Good Manufacturing Practices requirements, or cGMPs, and current Good Clinical Practices
requirements, or GCPs, for any clinical trials that we conduct post-approval.
After approval, our products could be subject
to labeling and other restrictions and we may be required to withdraw from the market or be subject to penalties if we fail to comply
with regulatory requirements.
The product labeling, advertising and promotion
of our products and our product candidates, if approved, are subject to regulatory requirements and continuing regulatory review. Government
authorities, including the FDA and the Office of the Inspector General of the Department of Health and Human Services, or OIG, strictly
regulate the promotional claims and activities that may be made about prescription products. A drug product may not be promoted for uses
that are inconsistent with the product’s approved labeling. If we receive marketing approval for tecarfarin, physicians may nevertheless
legally prescribe our products to their patients in a manner that is inconsistent with the approved labeling. However, if we are found
to have promoted such off-label uses, we may become subject to significant liability and government fines. The federal government has
extracted very large settlements and levied very large civil and criminal fines against companies for alleged improper promotion, has
enjoined companies from engaging in off-label promotion, and made companies agree to onerous multi-year corporate integrity agreements.
The FDA has also requested that companies enter into consent decrees of permanent injunctions under which specified promotional conduct
is changed or curtailed. The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates
and generate revenue. Adverse regulatory action, whether pre- or post-approval, can also potentially lead to product liability claims
and increase our product liability exposure.
We are subject, directly or indirectly,
to federal and state obligations and regulations applicable to our marketing practices. If we are unable to comply, or have not complied,
with such laws, we could face substantial penalties.
Our marketing and sales operations are subject
to various federal and state fraud and abuse laws, including, without limitation, the federal and state anti-kickback statutes and false
claims laws. With respect to sales and marketing activities by us or any future partner, advertising and promotional materials must comply
with FDA rules in addition to other applicable federal, state and local laws in the United States and similar legal requirements in other
countries. We also are subject, directly or indirectly through our customers and partners, to various fraud and abuse laws, including,
without limitation, the U.S. Federal Healthcare Program Anti-Kickback Statute, U.S. False Claims Act, and similar state laws, which impact,
among other things, most of our interactions with customers, including our proposed sales, marketing, and scientific/educational grant
programs. We are also subject to complex laws and regulation regarding reporting and payment obligations as a result of our participation
in the U.S. Medicaid Drug Rebate Program, the Federal Supply Schedule of the U.S. Department of Veterans Affairs, and other government
drug programs. All of these activities are also potentially subject to U.S. federal and state consumer protection and unfair competition
laws. Similar requirements exist in many of these areas in other countries. If investigated, we could be forced to incur substantial expense
responding to the investigation and defending our actions. If unsuccessful in our defense, we could be found to be in violation and subject
to substantial fines and penalties,
We currently do not have an agreement with
a third-party manufacturer for the production of tecarfarin and intend to rely upon third parties to produce our product candidate.
We currently do not have an agreement with any
third-party manufacturers for the production of tecarfarin and there can be no assurance that we will be able to enter into an agreement
on acceptable terms. If an agreement is not entered into, we may experience longer manufacturing lead times for any purchase orders we
place with a manufacturer under purchase orders. We intend to rely on third-party manufacturers to produce tecarfarin for our clinical
studies who are expected to purchase materials from third-party vendors and transport the materials necessary to produce tecarfarin, such
as the required reagents and containers. If a third-party manufacturer was to experience any prolonged disruption for our manufacturing,
or face enforcement scrutiny by regulatory authorities, we could be forced to seek additional third-party manufacturing contracts, thereby
increasing our development costs and negatively impacting our timelines and any commercialization costs. If we change manufacturers at
any point during the development process or after approval of a product candidate, we will be required to demonstrate comparability between
the product manufactured by the old manufacturer and the product manufactured by the new manufacturer. If we are unable to do so, we may
need to conduct additional clinical trials with product manufactured by the new manufacturer, thereby delaying our NDA submission or approval.
If the manufacturer upon which we rely fails
to comply with stringent regulations, we may face delays in the development and commercialization of, or be unable to meet demand for,
our product candidates and may lose potential revenues.
Any problems or delays our contract manufacturers
experience in preparing for commercial-scale manufacturing of a product candidate or component may result in a delay in product development
timelines and FDA or comparable foreign regulatory authority approval of the product candidate or may impair our ability to manufacture
commercial quantities or such quantities at an acceptable cost and quality, which could result in the delay, prevention, or impairment
of clinical development and commercialization of our product candidates and may materially harm our business, financial condition, results
of operations, stock price and prospects.
In addition, manufacturers of drug products and
their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with
cGMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents. Although we do
not have day-to-day control over our contract manufacturers’ compliance with these requirements, we are responsible for ensuring
compliance with such requirements. Our failure, or the failure of our contract manufacturers, to comply with applicable regulations could
result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal
of approvals, revocation of licenses, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any
of which would significantly and adversely affect supplies of our product candidates and our business. If a contract manufacturer’s
facilities do not pass a pre-approval inspection or do not have a cGMP compliance status acceptable to the FDA or a comparable foreign
regulatory authority, our product candidate will not be approved.
In addition, application holders must obtain FDA
approval for product and manufacturing changes, depending on the nature of the change. Moreover, in the United States, the distribution
of product samples to physicians must comply with the requirements of the U.S. Prescription Drug Marketing Act. In addition, our marketed
products will have to comply with the Drug Supply Chain Security Act of 2013, which requires drug companies to enable electronic tracking
of their products though the U.S. supply chain.
Any deviations from regulatory requirements may
also require remedial measures that may be costly and/or time-consuming for us or a third-party to implement and that may include the
temporary or permanent suspension of a clinical trial or the temporary or permanent closure of a facility. Any such remedial measures
imposed upon us or third parties with whom we contract could materially harm our business. Any delays in obtaining products or product
candidates that comply with the applicable regulatory requirements may result in delays to product approvals, and commercialization. It
may also require that we conduct additional trials.
We face substantial competition, which may
result in others discovering, developing or commercializing competing products more successfully than we do, or, perhaps obtaining approval
before our product and, potentially delaying our approval.
The development and commercialization of new drugs
is highly competitive. We face competition with respect to developing our current product candidates, and we will face competition with
respect to any products that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical
companies and biotechnology companies worldwide. We are seeking to develop tecarfarin as a marketable VKA, once-daily OAC designed to
treat and prevent thrombosis for ESRD patients with AFib. If we succeed in developing tecarfarin, we shall face substantial competition.
Traditionally, the drug of choice for CKD/ESRD patients has been warfarin. The reasoning for such therapy is that warfarin undergoes extensive
hepatic metabolism into inactive compounds, theoretically posing less risk to the renally impaired patient. Randomized trials to date
of apixaban versus warfarin for AFib excluded patients with severe and end-stage kidney disease, calculated creatinine clearance <25
mL per minute. The FDA cautiously extended apixaban use to patients with ESRD on hemodialysis based on limited pharmacokinetic data by
8 subjects. Additionally, the lower limit for creatinine clearance has been adjusted for rivaroxaban for stroke prevention in AFib, thereby
permitting use in the ESRD population. The remaining two DOACs, dabigatran and edoxaban, are approved for use with dosage adjustment in
moderate-severe CKD for stroke prevention. However, the net benefit of anticoagulation with apixaban or warfarin in the ESRD population
is controversial.
In 2019, RENal Hemodialysis Patients Allocated
Apixaban Versus Warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial was terminated early by the sponsor.
AXADIA is an investigator-driven, prospective,
parallel-group, single country, multi-center phase IIIb trial to assess the safety of apixaban versus the VKA phenprocoumon in patients
with non-valvular AFib and ESRD on hemodialysis treatment. The trial will be conducted in about 25-30 sites in Germany with an estimated
completion date of July 2023.
Strategies for the Management of Atrial Fibrillation
in patients Receiving Dialysis (SAFE-D) is a pilot trial in Toronto, Canada to evaluate the feasibility of conducting a randomized controlled
trial comparing anticoagulation strategies in patients with AFib receiving dialysis (either hemodialysis or peritoneal dialysis). The
trial was estimated to have been completed by December 31, 2022 (final data collection date for primary outcome measure).
Many of these named products are marketed by some
of the largest and most successful pharmaceutical companies. The companies that market these products have substantially more resources
than we do and substantially more experience developing and marketing pharmaceuticals. We may not be able to successfully compete with
these existing products. Potential competitors also include academic institutions, government agencies and other public and private research
organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing
and commercialization of competing drugs and potentially competing drugs. Our competitors are or may be attempting to develop therapeutics
for our target indications.
Factors affecting competition in these markets
include the financial, research and development, testing, and marketing strengths of individual competitors, trends in industry consolidation,
consumers’ product options, product quality, price and technology, reputation, customer service capabilities and access to market
partners and customers. Eliquis is manufactured and distributed by Bristol Myers Squibb, amiodarone is manufactured and distributed by
several companies including Sanofi, Baxter, and Pfizer, Pradaxa is manufactured and distributed by Boehringer Ingelheim, Xarelto is manufactured
and distributed by Janssen Pharmaceuticals, and Savaysa is manufactured and distributed by Daiichi Sankyo. Each of these organizations
has a long operating history, extensive resources, strong brand recognition and large customer bases. As a result, we expect they will
be able to devote greater resources than we can to the manufacture, promotion and sale of their products; receive greater resources and
support than we will from market partners and independent distributors; initiate and withstand substantial price competition; and take
advantage more readily than we could of acquisition and other strategic market opportunities. In addition, these or other organizations
could succeed in developing new products that perform better or more cost-effectively than our products and product candidates in their
respective markets. Moreover, changes in health trends, diet or other factors could substantially reduce the commercial attractiveness
or viability of the markets for anti-anginal, anticoagulant, anti-arrhythmic and anti-platelet products.
The high level of competition in these markets
could result in pricing pressure, reduced margins, the inability of our product candidates to achieve market acceptance and other impediments
to commercial success. As a result, there can be no assurance that we will be able to complete the development of competitive products
and commercialize them on a competitive basis.
Mergers and acquisitions in the pharmaceutical,
biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large
and established companies. These companies compete with us in recruiting and retaining qualified scientific and management personnel,
establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to,
or necessary for, our programs.
If serious adverse effects are identified
with respect to any of our product candidates or any of our approved products, we may need to modify or abandon our development of that
product candidate, discontinue sale of an approved product, or change our labeling to reflect new safety risks.
It is impossible to guarantee when, or if, any
of our product candidates will prove safe enough to receive regulatory approval. It is impossible to guarantee that safety issues that
may arise during development will not significantly decrease the commercial potential of our product candidates. In addition, there can
be no assurance that our clinical trials will identify all relevant safety issues. Known or previously unidentified adverse effects can
adversely affect regulatory approvals or marketing of approved products. In such an event, we might need to abandon marketing efforts
or development of that product or product candidate or enter into a partnership to continue development.
Serious adverse events have occurred in the clinical
trials of our product candidate. For example, major hemorrhages occurred in 1.6% of the blinded tecarfarin patients randomized in the
EMBRACE-AC trial. We expect that additional patients will experience serious adverse events in our future clinical trials and during marketing
if our products are approved. Design features of ACTOR AF, such as using a smaller number of patients and using MACE clinical outcomes
as an endpoint, may produce results that show an imbalance in adverse events between treatment groups, when no such imbalance truly exists,
or may not permit an assessment of the risk of rare events (due to the overall reduced size of the safety database), either of which could
lead the FDA to require additional studies to demonstrate the safety of tecarfarin.
If a regulatory agency discovers adverse events
of unanticipated severity or frequency it may impose restrictions on that product or us, including requiring withdrawal of the product
from the market. Among other legal and administrative actions, a regulatory agency may:
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mandate modifications to product labelling or promotional materials or require us to provide corrective information to healthcare practitioners; |
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withdraw any regulatory approvals; |
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place any ongoing clinical trials on clinical hold; |
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refuse to approve pending applications or supplements to approved applications filed by us, our partners or our potential future partners; |
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impose restrictions on operations, including costly new manufacturing, licensing or packaging requirements; or |
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seize or detain products or require a product recall. |
In addition, the occurrence of any of the foregoing,
even if promptly remedied, could (1) negatively impact the perception of us or the relevant product among the medical community, patients
or third-party payors and (2) result in product liability litigation that could result in the company paying substantial amounts of money
in settlements or verdicts.
Recently enacted and future legislation
may increase the difficulty and cost for us to obtain marketing approval of and commercialize tecarfarin and affect the prices we may
obtain.
In the United States and some foreign jurisdictions,
there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent
or delay marketing approval for tecarfarin, restrict or regulate post-approval activities and affect our ability to profitably sell tecarfarin.
Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities
for pharmaceutical products. We do not know whether additional legislative changes will be enacted, or whether the FDA regulations, guidance
or interpretations will be changed, or what the impact of such changes on the marketing approvals of tecarfarin, if any, may be. In addition,
increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as
well as subject us to more stringent product labeling and post-marketing testing and other requirements.
In the United States, under the Medicare Modernization
Act, or MMA, Medicare Part D provides coverage to the elderly and disabled for outpatient prescription drugs by approving and subsidizing
prescription drug plans offered by private insurers. The MMA also authorizes Medicare Part D prescription drug plans to use formularies
where they can limit the number of drugs that will be covered in any therapeutic class. The Part D plans use their formulary leverage
to negotiate rebates and other price concessions from drug manufacturers. Also under the MMA, Medicare Part B provides coverage to the
elderly and disabled for physician-administered drugs on the basis of the drug’s average sales price, a price that is calculated
according to regulatory requirements and that the manufacturer reports to Medicare quarterly.
Both Congress and the Centers for Medicare &
Medicaid Services, or CMS, the agency that administers the Medicare program, from time to time consider legislation, regulations, or other
initiatives to reduce drug costs under Medicare Parts B and D. For example, under the 2010 Affordable Care Act, drug manufacturers are
required to provide a 50% discount on prescriptions for branded drugs filled while the beneficiary is in the Medicare Part D coverage
gap, also known as the “donut hole.” The Bipartisan Budget Act of 2018 increased the manufacturer’s subsidy under the
program from 50% to 70% of the negotiated price, beginning in 2019. There have been legislative proposals to repeal the “non-interference”
provision of the MMA to allow CMS to leverage the Medicare market share to negotiate larger Part D rebates. Further cost reduction efforts
could decrease the coverage and price that we receive for tecarfarin and could seriously harm our business. Private payors often follow
Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement under the
Medicare program may result in a similar reduction in payments from private payors.
The 2010 Affordable Care Act is intended to broaden
access to health Insurance and reduce or constrain the growth of healthcare spending. Further, the Affordable Care Act imposes a significant
annual fee on companies that manufacture or import branded prescription drug products. It also increased the amount of the rebates drug
manufacturers must pay to state Medicaid programs, required that Medicaid rebates be paid on managed Medicaid utilization, and increased
the additional rebate on “line extensions” (such as extended-release formulations) of solid oral dosage forms of branded products.
The law also contains substantial provisions affecting fraud and abuse compliance and transparency, which may require us to modify our
business practices with healthcare practitioners, and incur substantial costs to ensure compliance.
Many members of the Republican Party have consistently
opposed the Affordable Care Act since it was signed. Efforts to repeal the Act have been attempted numerous times and some portions of
the Act have been amended in 2017 and 2018. It is unclear whether further amendments or repeal will be effectuated and what the effect
on the healthcare sector will be. In addition to potential changes to the Affordable Care Act, there are indications that the Medicaid
and Medicare programs may be restructured, which could lead to revisions in coverage and reimbursement of prescription drugs. While we
are unable to predict what legislation, if any, may potentially be enacted, to the extent that future changes affect how our product candidates
could be paid for and/or reimbursed by the government and private payers, our business could be adversely affected.
In addition, other legislative changes have been
proposed and adopted in the United States since the Affordable Care Act was enacted. For example, the Budget Control Act of 2011 included,
among other things, provisions that have led to 2% across-the-board reductions in Medicare payment amounts. Several states have adopted
or are considering adopting laws that require pharmaceutical companies to provide notice prior to raising prices and to justify price
increases. We expect that additional healthcare reform measures will be adopted in the future, any of which could limit the amounts that
federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value
of certain development projects and reduce our profitability.
If we market any of our products in a manner
that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal
penalties.
The FDA and other government authorities enforce
laws and regulations that require that the promotion of pharmaceutical products be consistent with the approved prescribing information.
While physicians may prescribe an approved product for a so-called “off-label” use under the practice of medicine, it is unlawful
for a pharmaceutical company to promote its products in a manner that is inconsistent with its approved label and any company which engages
in such conduct may be subject to significant liability. Similarly, industry codes in the European Union and other foreign jurisdictions
prohibit companies from engaging in off-label promotion and regulatory agencies in various countries enforce violations of the code with
civil penalties. While we intend to ensure that our promotional materials are consistent with our label, regulatory agencies may disagree
with our assessment and may issue untitled letters, warning letters or may institute other civil or criminal enforcement proceedings.
In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal healthcare fraud and
abuse laws have been applied in recent years to restrict certain marketing practices in the pharmaceutical industry. These laws include
the U.S. Federal Healthcare Program Anti-Kickback Statute, U.S. False Claims Act and similar state laws. Because of the breadth of these
laws and the narrowness of the safe harbors, it is possible that some of our business activities could be subject to challenge under one
or more of these laws.
The U.S. Federal Healthcare Program Anti-Kickback
Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in
return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable
under Medicare, Medicaid or other federally financed healthcare programs. This statute has been interpreted broadly to apply to arrangements
between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Although there are
several statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe
harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be
subject to scrutiny if they do not qualify for an exemption or safe harbor. Our practices may not, in all cases, meet all of the criteria
for safe harbor protection from anti-kickback liability. Moreover, recent health care reform legislation has strengthened these laws.
For example, the Affordable Care Act, among other things, amends the intent requirement of the U.S. Federal Healthcare Program Anti-Kickback
Statute and criminal health care fraud statutes; a person or entity no longer needs to have actual knowledge of this statute or specific
intent to violate it. In addition, the Affordable Care Act provides that the government may assert that a claim including items or services
resulting from a violation of the U.S. Federal Healthcare Program Anti-Kickback Statute constitutes a false or fraudulent claim for purposes
of the U.S. False Claims Act. Federal false claims laws, including the U.S. False Claims Act, impose criminal and civil penalties, including
through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented,
to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an
obligation to pay money to the federal government.
Over the past few years, pharmaceutical and other
healthcare companies have been prosecuted under these laws for a variety of alleged promotional and marketing activities, such as: allegedly
providing free trips, free goods, sham consulting fees and grants and other monetary benefits to prescribers; reporting to pricing services
inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in off-label promotion
that caused claims to be submitted to Medicare or Medicaid for non-covered, off-label uses; using a charity as an illegal conduit to cover
the copays of Medicare patients; and submitting inflated best price information to the Medicaid Drug Rebate Program to reduce liability
for Medicaid rebates.
Other restrictions under applicable U.S. federal
and state healthcare laws and regulations may include the following:
| ● | the
federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for, among other
things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program or making false
statements relating to healthcare matters; |
| ● | HIPAA,
as amended by the Health Information Technology for Economic and Clinical Health, or HITECH, Act and its implementing regulations, also
imposes obligations, including mandatory contractual terms, on certain types of people and entities with respect to safeguarding the
privacy, security and transmission of individually identifiable health information; |
| ● | the
federal Physician Payment Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics, and medical supplies for
which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report
payments and other transfers of value to physicians and teaching hospitals, as well as certain ownership and investment interests held
by physicians and their immediate family, which includes annual data collection and reporting obligations; and |
| ● | analogous
state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements
and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. |
Some state laws require pharmaceutical companies
to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by
the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians
and other healthcare providers or marketing expenditures to federal and state agencies. State and foreign laws also govern the privacy
and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted
by HIPAA, thus complicating compliance efforts. Tracking and reporting may be burdensome and require a significant expenditure to comply
with applicable requirements.
Our ability to generate product revenues
will be diminished if our products sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement.
Our ability to commercialize our products, alone
or with collaborators, will depend in part on the extent to which reimbursement will be available from:
| ● | government
and health administration authorities; |
| ● | private
health maintenance organizations and health insurers; and |
| ● | other
healthcare payers. |
Patients generally expect that products such as
ours are covered and reimbursed by third-party payors for all or part of the costs and fees associated with their use. If such products
are not covered and reimbursed then patients may be responsible for the entire cost of the product, which can be substantial. Therefore,
health care providers generally do not prescribe products that are not covered and reimbursed by third-party payors in order to avoid
subjecting their patients to such financial liability. The existence of adequate coverage and reimbursement for the products by government
and private insurance plans is central to the acceptance of tecarfarin and any future products we provide.
During the past several years, third-party payors
have undertaken cost-containment initiatives including different payment methods, monitoring health care expenditures, and anti-fraud
initiatives. For some governmental programs, such as Medicaid, coverage and reimbursement differ from state to state, and some state Medicaid
programs may not pay an adequate amount for tecarfarin or any of our other products or may make no payment at all. Furthermore, the health
care industry in the United States has experienced a trend toward cost containment as government and private insurers seek to control
health care costs by imposing lower payment rates and negotiating reduced contract rates with service providers. Therefore, we cannot
be certain that our services will be reimbursed at a level that is sufficient to meet our costs.
Obtaining coverage and reimbursement approval
of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to the
payor supporting scientific, clinical and cost-effectiveness data for the use of our products. Even if we obtain coverage for a given
product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments
that patients find unacceptably high. Patients are unlikely to use tecarfarin or any future product candidates unless coverage is provided
and reimbursement is adequate to cover a significant portion of the cost of tecarfarin or any future product candidates.
We intend to seek approval to market tecarfarin
and future product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign
jurisdictions for tecarfarin or any future product candidates, we will be subject to rules and regulations in those jurisdictions. In
some foreign countries, particularly those in the European Union, the pricing of drugs is subject to governmental control. In these countries,
pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate.
In addition, market acceptance and sales of product candidates will depend significantly on the availability of adequate coverage and
reimbursement from third-party payors for product candidates and may be affected by existing and future health care reform measures.
Third-party payors, whether domestic or foreign,
or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In both the United States
and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could
impact our ability to sell our products profitably. In particular, in the Affordable Care Act, as amended by the Health Care and Education
Affordability Reconciliation Act, among other things, revised the methodology by which rebates owed by manufacturers to the state and
federal government for covered outpatient drugs, including product candidates, under the Medicaid Drug Rebate Program are calculated,
increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate
program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, subjected manufacturers to new
annual fees and taxes for certain branded prescription drugs, and provided incentives to programs that increase the federal government’s
comparative effectiveness research.
There have been, and likely will continue to be,
legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and
containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future, particularly in light
of the new presidential administration in the United States, and any proposed changes to healthcare laws that could potentially affect
our clinical development or regulatory strategy. The continuing efforts of the government, insurance companies, managed care organizations
and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:
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demand for tecarfarin, or future product candidates, if we obtain regulatory approval; |
| ● | our
ability to set a price that we believe is fair for our products; |
| ● | our
ability to generate revenue and achieve or maintain profitability; |
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level of taxes that we are required to pay; and |
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availability of capital. |
Any reduction in reimbursement from Medicare,
Medicaid or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our
future profitability.
We will rely on third parties and consultants
to conduct all of our clinical trials. If these third parties or consultants do not successfully carry out their contractual duties, comply
with regulatory requirements, or meet expected deadlines, we may be unable to obtain regulatory approval for any future product candidates.
We will rely on medical institutions, clinical
investigators, contract laboratories, collaborative partners and other third parties, such as CROs, to conduct clinical trials on our
product candidates. The third parties with whom we may contract for execution of any of our future clinical trials may play a significant
role in the conduct of these trials and the subsequent collection and analysis of data. These third parties would not be our employees,
and except for contractual duties and obligations, we would have limited ability to control the amount or timing of resources that they
devote to any of our future programs. Although we may rely on these third parties to conduct our clinical trials, we would remain responsible
for ensuring that each of our preclinical trials and clinical trials is conducted in accordance with applicable legal requirements, the
investigational plan and the protocol. Moreover, whether we conduct trials ourselves or hire third parties to do so, the FDA and other
similar regulatory authorities require us to comply with GCPs when we conduct, monitor, record and report the results of clinical trials
to ensure that the data and results are scientifically credible and accurate, and that the trial subjects are adequately informed of the
potential risks of participating in clinical trials.
In addition, the execution of clinical trials,
and the subsequent compilation and analysis of the data produced, requires coordination among various parties. In order for these functions
to be carried out effectively and efficiently, it is imperative that these parties communicate and coordinate with one another. Moreover,
these third parties may also have relationships with other commercial entities, some of which may compete with us. If the third parties
or consultants conducting our clinical trials do not perform their contractual duties or obligations, experience work stoppages, do not
meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy of the clinical data
they obtain is compromised due to the failure to adhere to our clinical trial protocols or GCPs, or for any other reason, we may need
to conduct additional clinical trials or enter into new arrangements with alternative third parties, which could be difficult, costly
or impossible, and our clinical trials may be extended, delayed or terminated or may need to be repeated. If any of the foregoing were
to occur, we may not be able to obtain, or may be delayed in obtaining, regulatory approval for and will not be able to, or may be delayed
in our efforts to, successfully commercialize any future product candidates being tested in such trials.
We currently have limited distribution,
marketing, support and sales capabilities and plan to rely on third-party distribution partners for the distribution, marketing, support
and sales of our products which could delay or limit our ability to generate revenue.
We plan to utilize third-party service providers
for the distribution and marketing and sales of our product candidates, if approved. Upon launch, we intend to promote utilizing third
party collaborations in addition to building our own commercial infrastructure in anticipation of the approval of tecarfarin. Reliance
on third-party service providers may prevent our direct control of key aspects of those critical functions including regulatory compliance,
import and export operations, supply chain security, warehousing and inventory management, distribution, contract administration, invoicing,
sales deductions administration, accounts receivable management and call center management. Any future distribution partners may hold
significant control over important aspects of the commercialization of our products, including market identification, regulatory compliance,
marketing methods, pricing, composition of sales force and promotional activities.
We may not be able to control the amount and timing
of resources that any future third-party distribution partners may devote to our products, or prevent any third-party from pursuing the
development of alternative technologies or products that compete with our products, except to the extent our contractual arrangements
protect us against such activities. Also, we may not be able to prevent any other third-party from withdrawing its support of our products.
If third-party service providers fail to comply
with applicable laws and regulations, fail to meet expected deadlines, encounter natural or other disasters at their facilities or otherwise
fail to perform their services to us in a satisfactory or predicted manner, or at all, our ability to deliver product to meet commercial
demand could be significantly impaired. In addition, we may use third parties to perform various other services for us relating to sample
accountability and regulatory monitoring, including adverse event reporting, safety database management and other product maintenance
services. If the quality or accuracy of the data maintained by these service providers is insufficient, our ability to continue to market
our products could be jeopardized or we could be subject to regulatory sanctions, and any indemnity we may receive from such third-party
service providers could be limited by such provider’s ability to pay and otherwise might not be sufficient to cover all losses we
may experience.
Our employees, independent contractors,
consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory
standards and requirements.
We are exposed to the risk of employee fraud or
other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties
could include intentional, reckless and/or negligent conduct that fails to: (i) comply with the laws of the FDA and other similar foreign
regulatory bodies; (ii) provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies; (iii)
comply with manufacturing standards we have established; (iv) comply with healthcare fraud and abuse laws in the United States and similar
foreign fraudulent misconduct laws; or (v) report financial information or data accurately or to disclose unauthorized activities to us.
Any such misconduct or noncompliance could negatively affect the FDA’s review of our regulatory submission, including delaying approval
or disallowance of certain information to support the submission, and/or delay a federal or state healthcare programs or a commercial
insurer’s determination regarding the availability of future reimbursement for product candidates. If we obtain FDA approval of
any product candidates and begin commercializing those products in the United States, our potential exposure under such laws will increase
significantly, and our costs associated with compliance with such laws are also likely to increase. These laws may impact, among other
things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and
education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements
in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices.
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s),
certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper
use of information obtained in the course of patient recruitment for clinical trials.
It is not always possible to identify and deter
employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown
or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure
to be in compliance with such laws or regulations. Efforts to ensure that our business arrangements will comply with applicable healthcare
laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices
may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws
and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights,
those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties,
damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs,
contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could
adversely affect our ability to operate our business and our results of operations. In addition, the approval and commercialization of
any product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above,
among other foreign laws.
We intend to establish a sales force to
market our product candidates. If we are not successful in doing so, our ability to generate sales and profits will be limited.
Although certain of our employees have commercialization
experience, as a company we do not have an internal sales force and we currently have only limited commercial capabilities. We intend
to establish an internal specialty cardiorenal sales force for the promotion and sale of tecarfarin, if approved. Establishing a pharmaceutical
sales force is a difficult undertaking. Experienced and competent sales representatives and sales managers must be recruited, hired, trained,
assigned appropriate territories, managed and compensated in such a way that they can achieve success in selling products to a sophisticated
audience of healthcare professionals who frequently have little or no time to spend with sales personnel. In addition, our prospective
sales force must compete against the sales forces of some of the largest and most successful pharmaceutical companies in the world, who
will be promoting competing products. If we fail to hire and field a high-quality sales force, we may be unable to generate expected revenues
and profits.
In addition, there are significant expenses and
risks involved with establishing our own sales and marketing capabilities, including our ability to hire, retain and appropriately incentivize
qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage
a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution
capabilities could delay any product launch, which would adversely impact the commercialization of our product candidates. For example,
if we recruit any sales representatives or establish marketing capabilities prior to commercial launch and the commercial launch is delayed
or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly,
and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.
In addition to our own internal sales force, we
may choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment our
own sales force and distribution systems or in lieu of our own sales force and distribution systems. If we are unable to enter into such
arrangements on acceptable terms or at all, we may not be able to successfully commercialize our product candidates. To the extent we
commercialize our product candidates by entering into agreements with third-party collaborators, we may have limited or no control over
the sales, marketing and distribution activities of these third parties, in which case our future revenues would depend heavily on the
success of the efforts of these third parties. If we are not successful in commercializing tecarfarin or any future product candidates,
either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we could incur
significant additional losses.
We plan to rely on collaborations and license
arrangements with third parties to commercialize, market and promote our marketed products which may limit our ability to generate revenue
and adversely affect our profitability.
We plan to rely on collaboration and other agreements
with third parties with third parties with respect to our product candidates and future marketed products. Our current or any future collaborations
or license arrangements may not be successful. With respect to the product candidates we have licensed, including our rights to tecarfarin
in China, we depend upon collaborations with third parties to develop these product candidates in the licensed territories and we will
depend substantially upon third parties to commercialize these product candidates. If we are unable to maintain current collaborations
or enter into additional collaborations with established pharmaceutical or pharmaceutical service companies to provide the services we
need, we may not be able to successfully commercialize our products.
Our future growth depends, in part, on our
ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
Although our focus as this time is primarily on
the U.S. market, our future profitability will depend, in part, on our ability to commercialize tecarfarin in foreign markets for which
we intend to rely on collaborations with third parties. If we commercialize tecarfarin in foreign markets, we would be subject to additional
risks and uncertainties, including:
| ● | our
customers’ ability to obtain reimbursement in foreign markets; |
| ● | our
inability to directly control commercial activities because we are relying on third parties; |
| ● | the
burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements; |
| ● | different
medical practices and customs in foreign countries affecting acceptance in the marketplace; |
| ● | import,
export and foreign licensing requirements; |
| ● | different
packaging and labeling requirements; |
| ● | longer
accounts receivable collection times; |
| ● | longer
lead times for shipping; |
| ● | language
barriers for technical training; |
| ● | differing
and/or reduced protection of intellectual property rights in some foreign countries; |
| ● | foreign
currency exchange rate fluctuations; and |
| ● | the
interpretation of contractual provisions governed by foreign laws in the event of a contract dispute. |
Foreign sales of tecarfarin could also be adversely
affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs, any
of which may adversely affect our results of operations.
The ongoing COVID-19 global health crisis
may impact our planned operations, including our pivotal Phase 3 clinical trial
In January 2020, the World Health Organization
declared a global pandemic for the novel strain of coronavirus, COVID-19. Since then, the COVID-19 coronavirus has spread to multiple
countries, including throughout the United States. We may experience disruptions as a result of the pandemic if the pandemic continues
or increases in severity, including:
| ● | unwillingness
of potential study participants to enroll in our pivotal Phase 3 clinical trial and/or visit healthcare facilities; |
| ● | postponement
of enrollment in our pivotal Phase 3 clinical trial |
| ● | postponement
of the initiation of our pivotal Phase 3 clinical trial; |
| ● | diversion
of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial
sites and hospital staff supporting the conduct of our clinical trial; |
| ● | interruption
of key clinical trial activities, such as clinical site visits by study participants and clinical trial site monitoring, due to limitations
on travel imposed or recommended by federal or state governments, employers and others; |
| ● | limitations
in employee resources that would otherwise be focused on the conduct of our pivotal Phase 3 clinical trial, including because of sickness
of employees or their families or the desire of employees to avoid contact with large groups of people; |
| ● | delays
in receiving approval from local regulatory authorities to initiate our pivotal Phase 3 clinical trial; |
| ● | delays
in clinical sites receiving the supplies and materials needed to conduct our pivotal Phase 3 clinical trial; |
| ● | interruption
in global shipping that may affect the manufacture and transport of clinical trial materials, such as investigational drug product used
in our clinical trial; |
| ● | changes
in local regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in which our
pivotal Phase 3 clinical trial is conducted, which may result in unexpected costs, or to discontinue the clinical trial altogether; |
| ● | delays
in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in
employee resources or forced furlough of government employees; and |
| ● | delay
in the timing of interactions with the FDA due to absenteeism by federal employees or by the diversion of their efforts and attention
to approval of other therapeutics or other activities related to COVID-19. |
Our business and the business of the suppliers
of our clinical product candidate is expected to be materially and adversely affected by the pandemic. While we are currently not experiencing
material delays, such events could result in the delay or complete or partial closure of clinical trial sites or one or more manufacturing
facilities which could impact our supply of our clinical product candidate. In addition, it could impact economies and financial markets,
resulting in an economic downturn that could impact our ability to raise capital or slow down potential partnering relationships.
The effects of the governmental orders may negatively
impact productivity, disrupt our business and delay our pivotal Phase 3 clinical trial program and timelines, the magnitude of which will
depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary
course.
In addition, the COVID-19 outbreak could disrupt
our operations due to absenteeism by infected or ill members of management or other employees, or absenteeism by members of management
and other employees who elect not to come to work due to the illness affecting others in our office, or due to quarantines. The COVID-19
illness could also impact members of our Board of Directors resulting in absenteeism from meetings of the directors or committees of directors,
and making it more difficult to convene the quorums of the full Board of Directors or its committees needed to conduct meetings for the
management of our affairs.
The global outbreak of the virus continues to
rapidly evolve. The extent to which the virus may continue to impact our business and clinical trials will depend on future developments,
which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration
of the outbreak, travel restrictions and social distancing in the United States, business closures or business disruptions and the effectiveness
of actions taken in the United States and other countries to contain and treat the disease. We do not yet know the full extent of potential
delays or impacts on our business, operations, or the global economy as a whole. While the spread of COVID-19 may eventually be contained
or mitigated, there is no guarantee that a future outbreak of this or any other widespread epidemics will not occur, or that the global
economy will recover, either of which could seriously harm our business.
While we are currently not experiencing any delays,
we may in the future experience delays. These delays may result in the need for trials to be redesigned and may impact whether they will
be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including the COVID-19 pandemic, delays
in obtaining regulatory approval to commence a clinical trial, in securing clinical trial agreements with prospective sites with acceptable
terms, in obtaining institutional review board approval to conduct a clinical trial at a prospective site, in recruiting patients to participate
in a clinical trial or in obtaining sufficient supplies of clinical trial materials. Manufacturing considerations for clinical development
candidates may include an expected several month lead time following a decision to commence any clinical trial(s) and capacity considerations
of our third-party contract manufacturers to provide clinical supply of our product candidates could cause delays in clinical trials.
Furthermore, due to the COVID-19 pandemic, many manufacturers have been prioritizing the manufacture of COVD-19 related products, increasing
the manufacturing lead times for non-COVID-19 related products. Many factors affect patient enrollment, including the size of the patient
population, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, competing clinical trials and
new drugs approved for the conditions we are investigating. Clinical investigators will need to decide whether to offer their patients
enrollment in clinical trials of our product candidates versus treating these patients with commercially available drugs that have established
safety and efficacy profiles. Any delays in completing our clinical trials will increase our costs, slow down our product development
and timeliness and approval process and delay our ability to generate revenue.
Compliance with governmental regulations
regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization
of our products.
The Animal Welfare Act, or AWA, is the federal
law that covers the treatment of certain animals used in research. Currently, the AWA imposes a wide variety of specific regulations that
govern the humane handling, care, treatment and transportation of certain animals by producers and users of research animals, most notably
relating to personnel, facilities, sanitation, cage size, and feeding, watering and shipping conditions. Third parties with whom we contract
are subject to registration, inspections and reporting requirements under the AWA. Furthermore, some states have their own regulations,
including general anti-cruelty legislation, which establish certain standards in handling animals. Comparable rules, regulations, and
or obligations exist in many foreign jurisdictions. If we or our contractors fail to comply with regulations concerning the treatment
of animals used in research, we may be subject to fines and penalties and adverse publicity, and our operations could be adversely affected.
General Company-Related Risks
If we fail to attract and keep senior management
and key scientific personnel, we may be unable to successfully develop tecarfarin or any future product candidates, conduct our clinical
trials and commercialize our product candidates or any future products we develop.
Our management team has expertise in many different
aspects of fundraising, drug development and commercialization. We believe that our future success is highly dependent upon the contributions
of our senior management, particularly Quang Pham, our Chief Executive Officer. We do not have an insurance policy on the life of our
Chief Executive Officer and we do not have “key person” life insurance policies for any of our other officers or advisors.
The loss of services of any of these individuals could delay or prevent the successful development of our product pipeline, completion
of our planned clinical trials or the commercialization of tecarfarin or any other future products we develop, which could adversely affect
our operating results.
We will need to hire additional personnel, including
experienced marketing and sales representatives, as we expand our clinical development and commercial activities. We could experience
difficulties attracting and retaining qualified employees in the future. For example, competition for qualified personnel in the pharmaceuticals
field is intense due to the limited number of individuals who possess the skills and experience required by our industry. Other pharmaceutical
companies with which we compete for qualified personnel have greater financial and other resources, different risk profiles, and a longer
history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of
these characteristics may be more appealing to high-quality candidates than what we have to offer. We may not be able to attract and retain
quality personnel on acceptable terms, or at all. In addition, to the extent we hire personnel from competitors, we may be subject to
allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information or that
their former employers own their research output. If we are unable to continue to attract and retain high-quality personnel, the rate
and success at which we can develop and commercialize product candidates could be limited.
We will need to increase the size of our
organization, and we may experience difficulties in managing this growth.
As of July 23, 2023, we had three employees who
work full-time as well as several independent contractors. We will need to continue to expand our managerial, operational, finance and
other resources to manage our operations, commercialize tecarfarin or any other product candidates, if approved, and continue our development
activities. Our management and personnel systems and facilities currently in place may not be adequate to support this future growth.
Our need to effectively execute our growth strategy requires that we:
| ● | manage
any of our future clinical trials effectively; |
| ● | identify,
recruit, retain, incentivize and integrate additional employees; |
| ● | manage
our internal development efforts effectively while carrying out our contractual obligations to third parties; and |
| ● | continue
to improve our operational, financial and management controls, reporting systems and procedures. |
Due to our limited financial resources and our
limited experience in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations
or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs and may divert
our management and business development resources. Any inability to manage growth could delay the execution of our development and strategic
objectives or disrupt our operations.
If product liability lawsuits are brought
against us, we may incur substantial liabilities and may be required to limit commercialization of any future products we develop.
We face an inherent risk of product liability
as a result of the clinical testing of tecarfarin and any of our future product candidates. We will face further risk if we commercialize
tecarfarin or any of our product candidates. For example, we may be sued if any product we sell or any product we develop allegedly causes
injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims
may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence,
strict liability and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully
defend ourselves against product liability claims, we may incur substantial losses or be required to limit commercialization of our products.
Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome,
liability claims may result in:
| ● | decreased
demand for our product candidates or products we develop, including tecarfarin; |
| ● | termination
of clinical trial sites or entire trial programs; |
| ● | injury
to our reputation and significant negative media attention; |
| ● | withdrawal
of clinical trial participants or cancellation of clinical trials; |
| ● | significant
costs to defend the related litigation; |
| ● | a
diversion of management’s time and our resources; |
| ● | substantial
monetary awards to trial participants or patients; |
| ● | regulatory
investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions; |
| ● | the
inability to commercialize any products we develop; and |
| ● | a
decline in our share price. |
Our inability to obtain and maintain sufficient
product liability insurance at an acceptable cost and scope of coverage to protect against potential product liability claims could prevent
or inhibit the commercialization of tecarfarin or any future products that we develop. We currently carry product liability insurance
covering our marketed products and our clinical trials. Although we maintain such insurance, any claim that may be brought against us
could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess
of the limits of our insurance coverage. Our insurance policies also have various exclusions and deductibles, and we may be subject to
a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement
that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital
to pay such amounts. Moreover, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient
amounts to protect us against losses. If and when we obtain approval for marketing tecarfarin, we intend to expand our insurance coverage
to include the sale of tecarfarin, however, we may be unable to obtain this liability insurance on commercially reasonable terms.
Our business and operations would suffer
in the event of computer system failures.
Despite the implementation of security measures,
our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural
disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the internet, attachments
to emails, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach or
disruption, particularly through cyber-attacks or cyber-intrusions, including by computer hackers, foreign governments, and cyber-terrorists,
has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.
If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our current or future
product development programs. For example, the loss of clinical trial data from completed or any future ongoing or planned clinical trials
could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the
extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure
of confidential or proprietary information, we could incur material legal claims and liability, damage to our reputation, and the further
development of our product candidates could be delayed.
Any failure to maintain the security of
information relating to our patients, customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise, could
expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm our reputation.
In connection with the pre-clinical and clinical
development, sales and marketing of our products and services, we may from time to time transmit confidential information. We also have
access to, collect or maintain private or confidential information regarding our clinical trials and the patients enrolled therein, employees,
and suppliers, as well as our business. Cyberattacks are rapidly evolving and becoming increasingly sophisticated. It is possible that
computer hackers and others might compromise our security measures, or security measures of those parties that we do business with now
or in the future, and obtain the personal information of patients in our clinical trials, vendors, employees and suppliers or our business
information. A security breach of any kind, including physical or electronic break-ins, computer viruses and attacks by hackers, employees
or others, could expose us to risks of data loss, litigation, government enforcement actions, regulatory penalties and costly response
measures, and could seriously disrupt our operations. Any resulting negative publicity could significantly harm our reputation, which
could cause us to lose market share and have an adverse effect on our results of operations.
We may acquire other businesses or form
joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’
ownership, increase our debt or cause us to incur significant expense.
As part of our business strategy, we may pursue
acquisitions of businesses and assets. We also may pursue strategic alliances and joint ventures that leverage our technology and industry
experience to expand our offerings or other capabilities. Though certain company personnel have business development and corporate transaction
experience, including with licensing, mergers and acquisitions, and strategic partnering, as a company we have no experience with acquiring
other companies and limited experience with forming strategic alliances and joint ventures. We may not be able to find suitable partners
or acquisition candidates, and we may not be able to complete such transactions on favorable terms, if at all. If we make any acquisitions,
we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent
liabilities. Any future acquisitions also could result in significant write-offs or the incurrence of debt and contingent liabilities,
any of which could have a material adverse effect on our financial condition, results of operations and cash flows. Integration of an
acquired company also may disrupt ongoing operations and require management resources that would otherwise focus on developing our existing
business. We may experience losses related to investments in other companies, which could have a material negative effect on our results
of operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may
not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.
To finance any acquisitions or joint ventures,
we may choose to issue shares of our Common Stock as consideration, which would dilute the ownership of our stockholders. If the price
of our Common Stock is low or volatile, we may not be able to acquire other companies or fund a joint venture project using our stock
as consideration. Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or private financings.
Additional funds may not be available on terms that are favorable to us, or at all.
Declining general economic or business conditions
may have a negative impact on our business.
Continuing concerns over U.S. health care reform
legislation and energy costs, geopolitical issues, the availability and cost of credit and government stimulus programs in the United
States and other countries have contributed to increased volatility and diminished expectations for the global economy. These factors,
combined with low business and consumer confidence, could precipitate an economic slowdown and recession. Additionally, political changes
in the U.S. and elsewhere in the world have created a level of uncertainty in the markets. If the economic climate does not improve or
deteriorate, our business, as well as the financial condition of our suppliers and our third-party payors, could be adversely affected,
resulting in a negative impact on our business, financial condition and results of operations.
Further, due to increasing inflation, operating
costs for many businesses have increased and, in the future, could impact demand or pricing manufacturing of our drug candidates or services
providers, employee wages. Inflation rates, particularly in the United States, have increased recently to levels not seen in years,
and increased inflation may result in increases in our operating costs (including our labor costs), reduced liquidity and limits on our
ability to access credit or otherwise raise capital. In addition, the Federal Reserve has raised, and may again raise, interest rates
in response to concerns about inflation, which coupled with reduced government spending and volatility in financial markets may have the
effect of further increasing economic uncertainty and heightening these risks.
Actual events involving reduced or limited liquidity,
defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services
industry or the financial services industry generally, or concerns or rumors about any events of these kinds, have in the past and may
in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank, was closed by the California
Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation as receiver. Although
we did not have any cash or cash equivalent balances on deposit with Silicon Valley Bank, uncertainty and liquidity concerns in the broader
financial services industry remain and the failure of Silicon Valley Bank and its potential near- and long-term effects on the biotechnology
industry and its participants such as our vendors, suppliers, and investors, may also adversely affect our operations and stock price.
We are actively monitoring the effects these disruptions
and increasing inflation could have on our operations.
These conditions make it extremely difficult for
us to accurately forecast and plan future business activities.
Risks Related to Our Intellectual Property
If we are unable to obtain and maintain
sufficient exclusivity and/or patent protection for our product candidates, or if the scope of the exclusivity or patent protection is
not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to commercialize
our product candidates successfully may be adversely affected.
Our success depends in large part on our ability
to obtain and maintain exclusivity for our proprietary product candidates through market and data exclusivity granted by regulatory agencies
in the United States and other countries with respect to our proprietary product candidates as well as through patent protection. If we
do not adequately protect our intellectual property, competitors may be able to erode or negate any competitive advantage we may have,
which could harm our business and ability to achieve profitability. To protect our proprietary position, we file patent applications in
the United States and abroad related to our novel product candidates that are important to our business. The patent application and approval
process are expensive and time-consuming. We may not be able to file and prosecute all necessary or desirable patent applications at a
reasonable cost or in a timely manner.
The patent position of pharmaceutical companies
generally is highly uncertain. No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date
in the United States or in many foreign jurisdictions. In addition, the determination of patent rights with respect to pharmaceutical
compounds commonly involves complex legal and factual questions, which has in recent years been the subject of much litigation. As a result,
the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.
Assuming the other requirements for patentability
are met, currently, the first to file a patent application is generally entitled to the patent. However, prior to March 16, 2013, in the
United States, the first to invent was entitled to the patent. Publications of discoveries in the scientific literature often lag behind
the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months
after filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our
patents, or that we were the first to file for patent protection of such inventions.
Moreover, because the issuance of a patent is
not conclusive as to its inventorship, scope, validity or enforceability, our patents may be challenged in the courts or patent offices
in the United States and abroad. For example, we may be subject to a third-party preissuance submission of prior art to the U.S. Patent
and Trademark Office, or USPTO, or become involved in post-grant review procedures, oppositions, derivations, reexaminations, inter
partes review or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights of
others. An adverse determination in any such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated
or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical
technology and products, or limit the duration of the patent protection of our technology and products. In addition, given the amount
of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might
expire before or shortly after such candidates are commercialized.
Our future patent applications may not result
in patents being issued which protect our product candidates, in whole or in part, or which effectively prevent others from commercializing
competitive products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries
may diminish the value of our patents or narrow the scope of our patent protection. In addition, the laws of foreign countries may not
protect our rights to the same extent or in the same manner as the laws of the United States. For example, European patent law restricts
the patentability of methods of treatment of the human body more than United States law does.
Even if our patent applications issue as patents,
they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise
provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative
technologies or products in a non-infringing manner. Our competitors may also seek approval to market their own products similar to or
otherwise competitive with our products. Alternatively, our competitors may seek to market generic versions of any approved products by
submitting ANDAs to the FDA in which they claim that patents owned or licensed by us are invalid, unenforceable or not infringed. In these
circumstances, we may need to defend or assert our patents, or both, including by filing lawsuits alleging patent infringement. In any
of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid or unenforceable, or that our competitors
are competing in a non-infringing manner. Thus, even if we have valid and enforceable patents, these patents still may not provide protection
against competing products or processes sufficient to achieve our business objectives.
Depending upon the timing, duration and conditions
of FDA marketing approval of our product candidates, one or more of our U.S. patents may be eligible for limited patent term extension
under the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved
product as compensation for effective patent term lost during product development and the FDA regulatory review process. However, we may
not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise
fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. If we are unable to obtain
patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights
for that product will be shortened compared to expectations and our competitors may obtain approval to market competing products sooner.
As a result, our revenue from applicable products could be reduced, possibly materially. Further, if this occurs, our competitors may
take advantage of our investment in development and trials by referencing our clinical and preclinical data and launch their product earlier
than might otherwise be the case.
To date, we have not engaged intellectual
property counsel to conduct a freedom to operate analysis.
While we have engaged intellectual property counsel
to assist in protecting our patent ownership rights, to date, we have not had intellectual property counsel conduct a freedom to operate
analysis regarding our tecarfarin product. As a result, we cannot be certain that we will not be exposed to third party legal claims,
liabilities and/or litigation actions when we seek to develop, make and market products using our tecarfarin technology.
We may become involved in lawsuits to protect
or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
Competitors may infringe our patents, trademarks,
copyrights or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims,
which can be expensive and time consuming and divert the time and attention of our management and scientific personnel. Any claims we
assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents,
in addition to counterclaims asserting that our patents are invalid or unenforceable, or both. In any patent infringement proceeding,
there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or in part, and that we do not have
the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents is
upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from
using the invention at issue on the grounds that our patent claims do not cover the invention. An adverse outcome in a litigation or proceeding
involving our patents could limit our ability to assert our patents against those parties or other competitors, and may curtail or preclude
our ability to exclude third parties from making and selling similar or competitive products. Any of these occurrences could adversely
affect our competitive business position, business prospects and financial condition.
Similarly, if we assert trademark infringement
claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted
trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such
trademarks.
Even if we establish infringement, the court may
decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be
an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation,
there is a risk that some of our confidential information could be compromised by disclosure during litigation. There could also be public
announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive
these results to be negative, it could have a material adverse effect on the price of shares of our Common Stock. Moreover, there can
be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically
last for years before they are concluded. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion
of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings.
If we are sued for infringing intellectual
property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or
commercializing our product candidates.
Our commercial success depends, in part, on our
ability to develop, manufacture, market and sell our product candidates without infringing the intellectual property and other proprietary
rights of third parties. If any third-party patents or patent applications are found to cover our product candidates or their methods
of use, we may not be free to manufacture or market our product candidates as planned without obtaining a license, which may not be available
on commercially reasonable terms, or at all.
There is a substantial amount of intellectual
property litigation in the pharmaceutical industry, and we may become party to, or threatened with, litigation or other adversarial proceedings
regarding intellectual property rights with respect to our product candidates, including interference and other administrative proceedings
before the USPTO. Third parties may assert infringement claims against us based on existing or future intellectual property rights. The
outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance. The pharmaceutical
industry has produced a significant number of patents, and it may not always be clear to industry participants, including us, which patents
cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation
is not always uniform. If we were sued for patent infringement, we would need to demonstrate that our product candidates, products or
methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and we
may not be able to do this. In the United States, proving invalidity (except in proceedings before the USPTO) requires a showing of clear
and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings,
we may incur substantial costs and the time and attention of our management and scientific personnel could be diverted in pursuing these
proceedings, which could significantly harm our business and operating results. In addition, we may not have sufficient resources to bring
these actions to a successful conclusion.
If we are found to infringe a third-party’s
intellectual property rights, we could be forced, including by court order, to cease developing, manufacturing or commercializing the
infringing product candidate or product. Alternatively, we may be required to obtain a license from such third-party in order to use the
infringing technology and continue developing, manufacturing or marketing the infringing product candidate. However, we may not be able
to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive,
thereby giving our competitors access to the same technologies licensed to us. In addition, we could be found liable for monetary damages,
including treble damages and attorney’’ fees if we are found to have willfully infringed a patent. A finding of infringement
could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially
harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar
negative impact on our business.
Changes to the patent law in the United
States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
As is the case with other pharmaceutical companies,
our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical
industry involves both technological and legal complexity and is therefore costly, time consuming and inherently uncertain. Recent patent
reform legislation in the United States and other countries, including the Leahy-Smith America Invents Act, or the Leahy-Smith Act, signed
into law in September 2011, could increase those uncertainties and costs. The Leahy-Smith Act includes a number of significant changes
to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more
efficient and cost-effective avenues for competitors to challenge the validity of patents. In addition, the Leahy-Smith Act has transformed
the U.S. patent system into a “first to file” system. The first-to-file provisions, however, only became effective in March
2013. Accordingly, it is not yet clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the
Leahy-Smith Act and its implementation could make it more difficult to obtain patent protection for our inventions and increase the uncertainties
and costs surrounding the enforcement or defense of our or our collaboration partner’’ issued patents, all of which could
harm our business, results of operations and financial condition.
The U.S. Supreme Court has ruled on several patent
cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent
owners in certain situations. Additionally, there have been recent proposals for additional changes to the patent laws of the United States
and other countries that, if adopted, could impact our ability to enforce our proprietary technology. Depending on future actions by the
U.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patents
could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents
that we might obtain in the future.
Obtaining and maintaining our patent protection
depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent
agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
Periodic maintenance fees on any issued patent
are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign
governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during
the patent application process. While an inadvertent lapse can, in many cases, be cured by payment of a late fee or by other means in
accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or
patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could
result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions
within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we fail to maintain
the patents and patent applications covering our product candidates, our competitive position would be adversely affected.
We may not be able to enforce our intellectual
property rights throughout the world.
Filing, prosecuting and defending patents on our
product candidates in all countries throughout the world would be prohibitively expensive. The requirements for patentability may differ
in certain countries, particularly in developing countries. Competitors may use our technologies in jurisdictions where we have not obtained
patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may obtain
patent protection, but where patent enforcement is not as strong as that in the United States. These products may compete with our products
in jurisdictions where we do not have any issued or licensed patents or where any future patent claims or other intellectual property
rights may not be effective or sufficient to prevent them from competing with us.
Moreover, our ability to protect and enforce our
intellectual property rights may be adversely affected by unforeseen changes in foreign intellectual property laws. Additionally, laws
of some countries outside of the United States and Europe do not afford intellectual property protection to the same extent as the laws
of the United States and Europe. Many companies have encountered significant problems in protecting and defending intellectual property
rights in certain foreign jurisdictions. This could make it difficult for us to stop the infringement of our patents or the misappropriation
of our other intellectual property rights. For example, many foreign countries have compulsory licensing laws under which a patent owner
must grant licenses to third parties. Consequently, we may not be able to prevent third parties from practicing our inventions in certain
countries outside the United States and Europe. Competitors may use our technologies in jurisdictions where we have not obtained patent
protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection,
if our ability to enforce our patents to stop infringing activities is inadequate. These products may compete with our products, and our
patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Proceedings to enforce our patent rights in foreign
jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and resources from other aspects of
our business. Furthermore, while we intend to protect our intellectual property rights in major markets for our products, we cannot ensure
that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our products. Accordingly,
our efforts to protect our intellectual property rights in such countries may be inadequate.
Patent terms may be inadequate to protect
our competitive position on our products for an adequate amount of time.
Given the amount of time required for the development,
testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such
candidates are commercialized. With respect to tecarfarin, we have two issued U.S. patents directed to tecarfarin. The expiration dates
of the patents are 2024 for both a composition of matter patent and a method of treatment patent. We expect to seek extensions of patent
terms in the United States and, if available, in other countries where we are prosecuting patents. In the United States, the Drug Price
Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the normal expiration of
the patent, which is limited to the approved indication (or any additional indications approved during the period of extension). However,
the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries,
may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may
grant more limited extensions than we request. If this occurs, our competitors may be able to take advantage of our investment in development
and clinical trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case.
We may be subject to claims by third parties
asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own
intellectual property.
We anticipate that many of the people that we
expect to hire as employees, including our one current employee, were previously employed at other pharmaceutical companies. Some of these
employees may have executed proprietary rights, non-disclosure and non-competition agreements, or similar agreements, in connection with
such previous employment. Although we try to ensure that our employees do not use the proprietary information or know-how of others in
their work for us, we may be subject to claims that we or these employees have used or disclosed intellectual property, including trade
secrets or other proprietary information, of any such third-party. Litigation may be necessary to defend against such claims. If we fail
in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel or
sustain damages. Such intellectual property rights could be awarded to a third-party, and we could be required to obtain a license from
such third-party to commercialize our technology or products. Such a license may not be available on commercially reasonable terms or
at all. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction
to management.
In addition, while we typically require our employees,
consultants and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual
property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that
we regard as our own, which may result in claims by or against us related to the ownership of such intellectual property. If we fail in
prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. Even
if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction
to our senior management and scientific personnel.
Risks Related to Ownership of Our Common Stock
An active public trading market for our
Common Stock may not be maintained.
Prior to our initial public offering consummated
on January 24, 2023, there was no public market or active private market for trading shares of our Common Stock. Our Common Stock is currently
traded on the Nasdaq Capital Market, but we can provide no assurance that we will be able to maintain an active trading market. The lack
of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable.
The lack of an active market may also reduce the price of shares of Common Stock. An inactive market may impair our ability to raise capital
by selling shares and our ability to use our capital stock to acquire other companies or technologies. We cannot predict the prices at
which our Common Stock will trade.
We cannot be assured that we will be able
to maintain our listing on the Nasdaq Capital Market.
Our securities are listed on The Nasdaq Capital
Market, a national securities exchange. We cannot be assured that we will continue to comply with the rules, regulations or requirements
governing the listing of our Common Stock on Nasdaq or that our securities will continue to be listed on Nasdaq in the future. If Nasdaq
should determine at any time that we fail to meet Nasdaq requirements, we may be subject to a delisting action by Nasdaq.
If Nasdaq delists our securities from trading
on its exchange at some future date, we could face significant material adverse consequences, including:
| ● | a
limited availability of market quotations for our securities; |
| ● | reduced
liquidity with respect to our securities; |
| ● | a determination that our Common Stock is a “penny stock”
which will require brokers trading in our Common Stock to adhere to more stringent rules, possibly resulting in a reduced level of trading
activity in the secondary trading market for our Common Stock; |
| ● | a
limited amount of news and analyst coverage for our company; and |
| ● | a
decreased ability to issue additional securities or obtain additional financing in the future. |
Our stock price has fluctuated in the past,
has recently been volatile and may be volatile in the future, and as a result, investors in our Common Stock could incur substantial losses.
Investors should consider an investment in our
Common Stock risky and invest only if they can withstand a significant loss and wide fluctuations in the market value of their investment.
Investors who purchase our Common Stock may not be able to sell their shares at or above the purchase price. Our stock price has been
volatile and may be volatile in the future. In addition, the ongoing COVID-19 pandemic has caused broad stock market and industry fluctuations.
The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often
been unrelated to the operating performance of particular companies. As a result of this volatility, investors may experience losses on
their investment in our Common Stock. Some of the factors that may cause the market price of our Common Stock to fluctuate include:
| ● | adverse
results or delays in our clinical trials; |
| ● | the
timing or delay of achievement of our clinical, regulatory, partnering and other milestones, such as the commencement of clinical development,
the completion of a clinical trial, the receipt of regulatory approval or the establishment or termination of a commercial partnership
for one or more of our product candidates; |
| ● | announcement
of FDA approval or non-approval of our product candidates or delays in the FDA review process; |
| ● | actions
taken by regulatory agencies with respect to our product candidates, our clinical trials or our sales and marketing activities; |
| ● | the
commercial success of any product approved by the FDA or its foreign counterparts; |
| ● | regulatory
developments in the United States and foreign countries; |
| ● | changes
in the structure of healthcare payment systems; |
| ● | any
intellectual property infringement lawsuit involving us; |
| ● | announcements
of technological innovations or new products by us or our competitors; |
| ● | market
conditions for the biotechnology or pharmaceutical industries in general; |
| ● | changes
in financial estimates or recommendations by securities analysts; |
|
● |
sales of large blocks of our Common Stock; |
|
● |
sales of our Common Stock by our executive officers, directors and significant stockholders; |
|
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direct sales of our Common Stock through financing arrangements; |
|
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restatements of our financial results and/or material weaknesses in our internal controls; |
|
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the loss of any of our key scientific or management personnel; and |
|
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announcements regarding the ongoing exploration of the strategic options available to us. |
The stock markets in general, and the markets
for biotechnology stocks in particular, have experienced extreme volatility and price and volume fluctuations that have often been unrelated
or disproportionate to the operating performance of particular companies. These broad market and industry factors may seriously harm the
market price of our Common Stock, regardless of our operating performance. In the past, class action litigation has often been instituted
against companies whose securities have experienced periods of volatility in market price. Any such litigation brought against us could
result in substantial costs, which would hurt our financial condition and results of operations, divert management’s attention and
resources, and possibly delay our clinical trials or commercialization efforts.
If financial or industry analysts do not
publish research or reports about our business or if they issue inaccurate or unfavorable commentary or downgrade our Common Stock, our
stock price and trading volume could decline.
The trading market for our Common Stock will be
influenced by the research and reports that industry or financial analysts publish about us or our business. We do not control these analysts
or the content and opinions included in their reports. As a new public company, we may be slow to attract research coverage, and the analysts
who publish information about our Common Stock will have had relatively little experience with our company, which could affect their ability
to accurately forecast our results and make it more likely that we fail to meet their estimates. In the event we obtain industry or financial
analyst coverage, if any of the analysts who cover us issue an inaccurate or unfavorable opinion regarding our stock price, our stock
price would likely decline. In addition, the stock prices of many companies in the biopharmaceutical industry have declined significantly
after those companies have failed to meet, or often times failed to exceed, the financial guidance publicly announced by the companies
or the expectations of analysts. If our financial results fail to meet, or significantly exceed, our announced guidance or the expectations
of analysts or public investors, analysts could downgrade our Common Stock or publish unfavorable research about us. If one or more of
these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets,
which in turn could cause our stock price or trading volume to decline.
Our officers, directors, and principal stockholders
exercise significant control over our Company, and may be able to control our management and operations, acting in their best interests
and not necessarily those of other stockholders.
Our executive officers, directors and principal
stockholders who beneficially own more than 5% or more of our outstanding Common Stock, in the aggregate, beneficially own shares representing
approximately 67.96% of our outstanding capital stock. Quang Pham, our Chief Executive Officer, beneficially owns 48.38% of our outstanding
capital stock. As a result, Mr. Pham alone and together with these other stockholders, acting together, may be able to significantly influence
any matters requiring approval by our stockholders, including the election of directors, the approval of mergers or other business combination
transactions. The interests of this group of stockholders may not always coincide with our interests or the interests of other stockholders.
The significant concentration of stock ownership may adversely affect the trading price of our Common Stock due to the perception that
conflicts of interest may exist or arise. Therefore, you should not invest in reliance on your ability to have any control over our company.
Future sales of Common Stock by our officers
and directors and principal stockholders or others of our Common Stock, or the perception that such sales may occur, could depress the
market price of our Common Stock.
Sales of a substantial number of shares of our
Common Stock, particularly sales by our directors, executive officers and principal stockholders could adversely affect the market price
of our Common Stock and may make it more difficult to sell Common Stock at a time and price that you deem appropriate.
All of the shares of Common Stock sold in our
initial public offering and the shares of our Common Stock by the Selling Stockholders in this offering will be freely tradable without
restrictions or further registration under the Securities Act, except for any shares held by our affiliates as defined in Rule 144 under
the Securities Act.
A substantial majority our outstanding shares
of Common Stock are currently restricted from resale as a result of market standoff and “lock-up” agreements with our officers
and directors. These shares will become available to be sold 60 days after following the effective date of the registration statement
of which this prospectus is a part. Shares held by directors, executive officers and other affiliates will be subject to volume limitations
under Rule 144 under the Securities Act and various vesting agreements. In addition, the underwriters may, in their sole discretion, release
all or some portion of the shares subject to market standoff or lock-up agreements prior to the expiration of the lock-up period. Sales
of a substantial number of such shares upon expiration of the market standoff and lock-up agreements, or the perception that such sales
may occur, or early release of these agreements, could cause our market price to fall or make it more difficult for you to sell your Common
Stock at a time and price that you deem appropriate.
We have registered the offer and sale of shares
of Common Stock that have been issued or reserved for future issuance under our equity compensation plans on a Form S-8 registration statement.
As a result, such shares can be freely sold in the public market upon issuance, subject to the market standoff or lock-up agreements or
unless they are held by “affiliates,” as that term is defined in Rule 144 of the Securities Act. If the holders of these shares
choose to sell a large number of shares, they could adversely affect the market price for our Common Stock.
We may also issue shares of our Common Stock or
securities convertible into shares of our Common Stock from time to time in connection with a financing, acquisition, investment or otherwise.
Any such issuance could result in substantial dilution to our existing stockholders and cause the trading price of our Common Stock to
decline.
Anti-takeover provisions in our charter
documents, and under Delaware law, could make an acquisition of our company, which may be beneficial to our stockholders, more difficult,
limit attempts by our stockholders to replace or remove our current management and limit the market price of our Common Stock.
Provisions in our amended and restated certificate
of incorporation and amended and restated bylaws may have the effect of delaying or preventing a merger, acquisition or other change of
control that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares.
These provisions could also limit the price that investors might be willing to pay in the future for shares of our Common Stock, thereby
depressing the market price of our Common Stock. In addition, because our board of directors is responsible for appointing the members
of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management
by making it more difficult for stockholders to replace members of our board of directors. Among other things, our amended and restated
certificate of incorporation and amended and restated bylaws include provisions that:
|
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authorize our board of directors to issue, without further action by the stockholders, shares of undesignated preferred stock with terms, rights, and preferences determined by our board of directors that may be senior to our Common Stock; |
|
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require that any action to be taken by our stockholders be effected at a duly called annual or special meeting and not by written consent; |
|
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specify that special meetings of our stockholders can be called only by our board of directors, the chairperson of our board of directors, or our Chief Executive Officer; |
|
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establish an advance notice procedure for stockholder proposals to be brought before an annual meeting, including proposed nominations of persons for election to our board of directors; |
|
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prohibit cumulative voting in the election of directors; |
|
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establish that our board of directors is divided into three classes — Class I, Class II, and Class III — with each class serving staggered three-year terms; |
|
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provide that, so long as our board of directors is classified, directors may only be removed for cause; |
|
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provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; and |
|
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require the approval of our board of directors or the holders of two-thirds of our outstanding shares of voting stock to amend our bylaws and certain provisions of our certificate of incorporation. |
These provisions may frustrate or prevent any
attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members
of our board of directors, which is responsible for appointing the members of our management. In addition, we are governed by the provisions
of Section 203 of the Delaware General Corporation Law, which generally, subject to certain exceptions, prohibits a Delaware corporation
from engaging in any of a broad range of business combinations with any “interested” stockholder for a period of three years
following the date on which the stockholder became an “interested” stockholder. Any of the foregoing provisions could limit
the price that investors might be willing to pay in the future for shares of our Common Stock, and they could deter potential acquirers
of our company, thereby reducing the likelihood that you would receive a premium for your shares of our Common Stock in an acquisition.
Our amended and restated certificate of
incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware or the federal district court
for the District of Delaware is the exclusive forum for certain disputes between us and our stockholders, which could result in increased
costs for our stockholders to bring a claim and could limit our stockholders’ ability to obtain a favorable judicial forum for disputes
with us or our directors, officers or employees.
Our amended and restated certificate of incorporation
and amended and restated bylaws provide that, unless the Company consents in writing to the selection of an alternative forum, the Court
of Chancery of the State of Delaware (or, in the event that the Court of Chancery does not have jurisdiction, the federal district court
for the District of Delaware or other state courts of the State of Delaware) is the exclusive forum for (i) any derivative action or proceeding
brought on our behalf; (ii) any action asserting a claim of breach of fiduciary duty owed by, any director, officer, employee or agent
of the Company to the Company or our stockholders; (iii) any action asserting a claim arising pursuant to any provision of the Delaware
General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws; or (iv) any action
asserting a claim against us or any director, officer of employee that is governed by the internal affairs doctrine of the law of the
State of Delaware; provided that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of
subject matter jurisdiction, or the Company consents in writing to the selection of an alternative forum, such action may be brought in
another state or federal court sitting in the State of Delaware. Our amended and restated certificate of incorporation and amended and
restated bylaws also provide that the federal district courts of the United States of America is the exclusive forum for the resolution
of any complaint asserting a cause of action arising under the Securities Act. Notwithstanding the foregoing, the exclusive forum provision
will not apply to claims brought to enforce any liability or duty created by the Exchange Act. Nothing in our amended and restated certificate
of incorporation or amended and restated bylaws preclude stockholders that assert claims under the Exchange Act from bringing such claims
in state or federal court, subject to applicable law.
We believe these provisions may benefit us by
providing increased consistency in the application of Delaware law and federal securities laws by chancellors and judges, as applicable,
particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other
forums and protection against the burdens of multi-forum litigation. However, this choice of forum provision could result in increased
costs for our stockholders to bring a claim and could may limit a stockholder’s ability to bring a claim in a judicial forum that
it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits
with respect to such claims, although our stockholders will not be deemed to have waived our compliance with federal securities laws and
the rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies’
certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisions
to be inapplicable or unenforceable. While the Delaware courts have determined that such choice of forum provisions are facially valid,
a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions, and there
can be no assurance that such provisions will be enforced by a court in those other jurisdictions. If a court were to find the choice
of forum provision that is contained in our amended and restated certificate of incorporation and amended and restated bylaws to be inapplicable
or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could
adversely affect our business and financial condition.
Claims for indemnification by our directors
and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available
to us.
Our amended and restated bylaws, provide that
we will indemnify our directors and executive officers, in each case to the fullest extent permitted by Delaware law.
In addition, as permitted by Section 145 of the
DGCL, our amended and restated bylaws and the indemnification agreements that we have entered into with each of our current executive
officers and intend to enter into with our directors and certain other officers, among other things provide that:
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We will indemnify our directors and executive officers for serving us in those capacities, or for serving as a director, officer, employee or agent of other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that we may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to our best interest and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful. |
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We may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law. |
|
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We will be required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification. |
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The rights conferred in our bylaws will not be exclusive. We may not retroactively amend our bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents. |
As a result, claims for indemnification by our
directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of
money available to us.
We do not intend to pay dividends in the
foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the price of our Common
Stock.
We have never declared or paid any cash dividends
on our Common Stock. We currently intend to retain all available funds and any future earnings for use in the operation of our business
and do not anticipate paying any dividends on our Common Stock in the foreseeable future. Any determination to pay dividends in the future
will be at the discretion of our board of directors. Consequently, your only opportunity to achieve a return on your investment in our
company will be if the market price of our Common Stock appreciates and you sell your shares at a profit. There is no guarantee that the
price of our Common Stock that will prevail in the market will ever exceed the price that you pay. For additional information about our
dividend policy, see the section entitled “Dividend policy” elsewhere in this prospectus.
Certain members of our management team have
limited experience managing a public company.
Some of the members of our management team have
limited experience managing a publicly traded company, interacting with public company investors, and complying with laws pertaining to
public companies. Our management team may not successfully or efficiently manage our transition to being a public company subject to significant
regulatory oversight and reporting obligations under the federal securities laws and the continuous scrutiny of securities analysts and
investors. These new obligations and constituents will require significant attention from our senior management and could divert their
attention away from the day-to-day management of our business, which could adversely affect our business, financial condition, and operating
results.
We have incurred significant increased costs
as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.
As a public company, we have incurred and will
continue to incur legal, accounting and other expenses that we did not incur as a private company. We are subject to the reporting requirements
of the Securities Exchange Act, and are required to comply with the applicable requirements of the Sarbanes-Oxley Act of 2002, or SOX,
and the Dodd-Frank Wall Street Reform and Consumer Protection Act, or Dodd-Frank. The listing requirements of the Nasdaq Stock Market,
and the rules of the SEC require that we satisfy certain corporate governance requirements. Our management and other personnel are required
to devote a substantial amount of time to ensure that we comply with all of these requirements. Moreover, the reporting requirements,
rules and regulations have increased our legal and financial compliance costs and will make some activities more time-consuming and costly.
Any changes we make to comply with these obligations may not be sufficient to allow us to satisfy our obligations as a public company
on a timely basis, or at all. These reporting requirements, rules and regulations, coupled with the increase in potential litigation exposure
associated with being a public company, could also make it more difficult for us to attract and retain qualified persons to serve on our
board of directors or board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’
and officers’ insurance, on acceptable terms.
As a public company, we will be required to maintain
internal control over financial reporting and to report any material weaknesses in such internal controls. Beginning with the second annual
report on Form 10-K that we will be required to file with the SEC, Section 404 requires an annual management assessment of the effectiveness
of our internal control over financial reporting. The rules governing the standards that must be met for management to assess our internal
control over financial reporting are complex and require significant documentation, testing, and possible remediation.
To date, we have not identified any material weaknesses
in our review of our internal controls for the purpose of providing the reports required by these rules. In the future, if we identify
material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of Section 404
of the Sarbanes-Oxley Act in a timely manner, or if we are unable to assert that our internal control over financial reporting is effective,
investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our Common Stock could
decline, and we could also become subject to investigations by the stock exchange on which our Common Stock is listed, the SEC or other
regulatory authorities, which could require additional financial and management resources. In addition, as a public company we will be
required to file accurate and timely quarterly and annual reports with the SEC under the Exchange Act. Any failure to report our financial
results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from Nasdaq or other adverse consequences
that would materially harm our business and reputation.
For so long as we remain an emerging growth company
as defined in the JOBS Act, we intend to take advantage of certain exemptions from various reporting requirements that are applicable
to public companies that are not emerging growth companies, including, but not limited to, not being required to comply with the auditor
attestation requirements of Section 404. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal
year (i) following the fifth anniversary of the completion of our initial public offering, (ii) in which we have total annual gross revenue
of at least $1.235 billion, or (iii) in which we are deemed to be a large accelerated filer, which means the market value of our Common
Stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, and (2) the date on which we have issued
more than $1.0 billion in non-convertible debt during the prior three-year period.
We are an emerging growth company and we
cannot be certain if (i) the reduced disclosure requirements or (ii) extended transition periods for complying with new or revised accounting
standards applicable to emerging growth companies will make our Common Stock less attractive to investors. In addition, as a smaller reporting
company we will also have reduced disclosure requirements.
We qualify as an emerging growth company. Under
the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply
to private companies. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent
to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to use this extended transition
period for complying with new or revised accounting standards that have different effective dates for public and private companies until
the earlier of the date we (i) are no longer an emerging growth company, or (ii) affirmatively and irrevocably opt out of the extended
transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with
new or revised accounting pronouncements as of public company effective dates.
In addition, for as long as we continue to be
an emerging growth company, we intend to take advantage of certain exemptions from various reporting requirements that are applicable
to other public companies including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic
reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and
stockholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our Common Stock
less attractive because we will rely on these exemptions. If some investors find our Common Stock less attractive as a result, there may
be a less active trading market for our Common Stock and our stock price may be more volatile.
We are also a “smaller reporting company”
as defined in the Securities Exchange Act, and have elected to take advantage of certain of the scaled disclosures available to smaller
reporting companies. To the extent that we continue to qualify as a “smaller reporting company” as such term is defined in
Rule 12b-2 under the Exchange Act, after we cease to qualify as an emerging growth company, certain of the exemptions available to us
as an “emerging growth company” may continue to be available to us as a “smaller reporting company,” including
exemption from compliance with the auditor attestation requirements pursuant to SOX and reduced disclosure about our executive compensation
arrangements. We will continue to be a “smaller reporting company” until we have $250 million or more in public float (based
on our Common Stock) measured as of the last business day of our most recently completed second fiscal quarter or, in the event we have
no public float (based on our Common Stock) or a public float (based on our Common Stock) that is less than $700 million, annual revenues
of $100 million or more during the most recently completed fiscal year.
We have broad discretion in the use of the
net proceeds from this offering and may not use them effectively.
Our management has broad discretion in the application
of the net proceeds from that offering, and you do not have the opportunity to assess whether the net proceeds are being used appropriately.
Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use
may vary substantially from their currently intended use. The failure by our management to apply those funds effectively could harm our
business.
Our need for future financing may result
in the issuance of additional securities, which will cause investors to experience dilution.
Our cash requirements may vary from those now
planned, depending upon numerous factors, including the results of future research and development activities. We expect our expenses
to increase if and when we initiate and conduct additional clinical trials, and seek marketing approval for our product candidates. In
addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses
related to product sales, marketing, manufacturing and distribution. Accordingly, we will need to obtain substantial additional funding
in connection with our continuing operations. There are no other commitments by any person for future financing. Our securities may be
offered to other investors at a price lower than the price per share offered to current stockholders, or upon terms which may be deemed
more favorable than those offered to current stockholders. In addition, the issuance of securities in any future financing may dilute
an investor’s equity ownership and have the effect of depressing the market price for our securities. Moreover, we may issue derivative
securities, including options and/or warrants, from time to time, to procure qualified personnel or for other business reasons. The issuance
of any such derivative securities, which is at the discretion of our board of directors, may further dilute the equity ownership of our
stockholders.
We have additional securities available
for issuance, which, if issued, could adversely affect the rights of the holders of our Common Stock.
Our Amended and Restated Certificate of Incorporation,
as amended, authorizes the issuance of 75,000,000 shares of our Common Stock and 7,500,000 shares of preferred stock. In certain circumstances,
the Common Stock, as well as the awards available for issuance under our equity incentive plans, can be issued by our board of directors,
without stockholder approval. Any future issuances of such stock would further dilute the percentage ownership of us held by holders of
preferred stock and Common Stock. In addition, the issuance of certain securities, including pursuant to the terms of our stockholder
rights plan, may be used as an “anti-takeover” device without further action on the part of our stockholders, and may adversely
affect the holders of the Common Stock.
Future sales of our Common Stock could cause
the market price for our Common Stock to decline.
We cannot predict the effect, if any, that market
sales of shares of our Common Stock or the availability of shares of our Common Stock for sale will have on the market price of our Common
Stock prevailing from time to time. Sales of substantial amounts of shares of our Common Stock in the public market, or the perception
that those sales will occur, could cause the market price of our Common Stock to decline or be depressed.
The shares of Common Stock issued in connection
with this offering will be freely tradable without restriction or further registration under the Securities Act.
Because we will not declare cash dividends
on our Common Stock in the foreseeable future, stockholders must rely on appreciation of the value of our Common Stock for any return
on their investment.
We have never declared or paid cash dividends
on our Common Stock. We currently anticipate that we will retain any future earnings from the development, operation and expansion of
our business and will not declare or pay any cash dividends in the foreseeable future. As a result, only appreciation of the price of
our Common Stock, if any, will provide a return to investors in this offering. See “Dividend Policy.”
Risks Related to the Private Placement and
Ownership of the Warrants
Our management will have broad discretion
over the use of the net proceeds from the Private Placement and may apply it to uses that do not improve our operating results or the
value of our securities.
Our management will have broad discretion over
the use of proceeds from the Private Placement. We intend to use the net proceeds from the Private Placement for working capital and other
general corporate purposes. Our management will have considerable discretion in the application of the net proceeds, and shareholders
will not have the opportunity, as part of their investment decision, to assess whether the proceeds are being used appropriately. The
net proceeds, if any, may be used for corporate purposes that do not improve our operating results or enhance the value of our Common
Stock. The failure of our management to use these funds effectively could have a material adverse effect on our business, cause the market
price of our Common Stock to decline and impair the commercialization of our products and/or delay the development of our product candidates.
Pending their use, we may invest the net proceeds from this offering in short-term, investment-grade, interest-bearing instruments and
U.S. government securities. These investments may not yield a favorable return to our stockholders.
There is no public market for the Pre-Funded Warrants, Common
Warrants or Placement Agent Warrants.
There is no established public trading market
for the Pre-Funded Warrants, Common Warrants or Placement Agent Warrants, and we do not expect a market to develop. In addition, we do
not intend to apply to list the Pre-Funded Warrants, Common Warrants or Placement Agent Warrants on Nasdaq or any national securities
exchange or other nationally recognized trading system. Without an active market, the liquidity of the Pre-Funded Warrants, Common Warrants
and Placement Agent Warrants will be limited.
We may not receive any additional funds
upon the exercise of the Pre-Funded Warrants, Common Warrants or Placement Agent Warrants.
Each Pre-Funded Warrant, Common Warrant and Placement
Agent Warrant may be exercised by way of a cashless exercise, meaning that the holder may not pay a cash purchase price upon exercise,
but instead would receive upon such exercise the net number of shares of our common stock determined according to the formula set forth
in the Pre-Funded Warrant, Common Warrant or Placement Agent Warrant. Accordingly, we may not receive any additional funds upon the exercise
of the Pre-Funded Warrants, Common Warrants or Placement Agent Warrants.
The Pre-Funded Warrants, Common Warrants
and Placement Agent Warrants are speculative in nature.
The Pre-Funded Warrants, Common Warrants and Placement
Agent Warrants do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends,
but rather merely represent the right to acquire shares of common stock at a fixed price for a limited period of time. Specifically, commencing
on the date of issuance, holders of the Common Warrants may exercise their right to acquire common stock and pay an exercise price of
$1.75 per share, subject to certain adjustments, prior to five and a half years from the date on which such Common Warrants were issued,
after which date any unexercised Common Warrants will expire and have no further value. Holders of Placement Agent Warrants may exercise
their right to acquire common stock and pay an exercise price of $2.1875 per share, subject to certain adjustments, prior to five and
a half years from the date on which such Placement Agent Warrants were issued, after which date any unexercised Placement Agent Warrants
will expire and have no further value. Holders of Pre-Funded Warrants have identical rights, except that the Pre-Funded Warrants have
an exercise price of $0.0001 and do not expire until exercised in full. The market value of the Pre-Funded Warrants, Common Warrants and
Placement Agent Warrants, if any, is uncertain and there can be no assurance that the market value of the Pre-Funded Warrants, Common
Warrants and Placement Agent Warrants will equal or exceed their imputed offering price. The Pre-Funded Warrants, Common Warrants and
Placement Agent Warrants will not be listed or quoted for trading on any market or exchange. There can be no assurance that the market
price of the common stock will ever equal or exceed the exercise price of the Common Warrants or Placement Agent Warrants and consequently,
whether it will ever be profitable for holders of the Common Warrants or Placement Agent Warrants to exercise the warrants.
Holders of the Common Warrants, Pre-Funded
Warrants and Placement Agent Warrants will have no rights as common stockholders with respect to the shares our Common Stock underlying
the warrants until such holders exercise their warrants and acquire our Common Stock, except as otherwise provided in the Common Warrants,
and Pre-Funded Warrants and Placement Agent Warrants.
Until holders of the Common Warrants, Pre-Funded
Warrants and/or and Placement Agent Warrants acquire shares of our Common Stock upon exercise thereof, such holders will have no rights
with respect to the shares of our Common Stock underlying such warrants, except to the extent that holders of such Common Warrants, Pre-Funded
Warrants and Placement Agent Warrants will have certain rights to participate in distributions or dividends paid on our common stock as
set forth in such warrants. Upon exercise of the Common Warrants, Pre-Funded Warrants and Placement Agent Warrants, the holders will be
entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.
USE OF PROCEEDS
The Selling Stockholders will receive all of the
proceeds of the sale of shares of Common Stock offered from time to time pursuant to this prospectus. Accordingly, we will not receive
any proceeds from the sale of shares of Common Stock that may be sold from time to time pursuant to this prospectus; however, we will
receive proceeds from the cash exercise of the Pre-Funded Warrants, Common Warrants and Placement Agent Warrants.
We will bear the out-of-pocket costs, expenses
and fees incurred in connection with the registration of shares of our Common Stock to be sold by the Selling Stockholders pursuant to
this prospectus. Other than registration expenses, the Selling Stockholders will bear any underwriting discounts, commissions, placement
agent fees or other similar expenses payable with respect to sales of shares of our Common Stock.
DIVIDEND POLICY
We presently intend to retain our earnings, if
any, to finance the development and growth of our business and operations and do not anticipate declaring or paying cash dividends on
our Common Stock in the foreseeable future.
Any future determination as to the declaration
and payment of dividends, if any, will be at the discretion of our board of directors and will depend on then-existing conditions, including
our operating results, financial condition, contractual restrictions, capital requirements, business prospects, and other factors our
board of directors may deem relevant. See “Risk Factors — Risks Related to Ownership of Our Common Stock — We do not
intend to pay dividends in the foreseeable future.”
MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis
of our financial condition and results of operations together with our financial statements and the related notes to those statements
included elsewhere in this prospectus. This discussion and analysis and other parts of this prospectus contain forward-looking statements
based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties
and assumptions, such as statements regarding our intentions, plans, objectives, expectations, forecasts and projections. Our actual results
and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several
factors, including those set forth under the section titled “Risk Factors” and elsewhere in this prospectus. You should carefully
read the “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially
from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”
Company Overview
We are focused on developing tecarfarin, a novel
therapy with orphan drug indication, designed for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients
with end-stage renal disease, or ESRD, and atrial fibrillation (irregular heartbeat), or AFib. We secured the rights to tecarfarin on
April 1, 2022 via an asset purchase agreement from HESP LLC, a wholly owned subsidiary of Horizon Technology Finance Corporation. HESP
LLC acquired the assets of Espero BioPharma, Inc., or Espero, including tecarfarin, in an assignment for the benefit of creditors in which
the creditor, Horizon Technology Finance Corporation and Horizon Credit II LLC (collectively, Horizon), a secured lender of Espero, designated
HESP LLC as the assignee of Espero’s assets.
Tecarfarin is an anticoagulant (blood thinner)
that uses a drug design process which targets a different pathway than the most commonly prescribed drugs used in the treatment of thrombosis
and AFib. Tecarfarin has been evaluated in eleven (11) human clinical trials conducted by its previous owners and other third parties
in over 1,003 individuals (269 patients were treated for at least six months and 129 patients were treated for one year or more). In Phase
1, Phase 2 and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with
chronic kidney disease, or CKD. In the Phase 2/3 trial, EMBRACE-AC, the largest tecarfarin trial with 607 patients having completed it,
only 1.6% of the blinded tecarfarin subjects suffered from major bleeding and there were no thrombotic events. Five patients died during
the trial, but only one death due to intracerebral hemorrhage was considered to be possibly related to the tecarfarin.
In 2019, the United States Food and Drug Administration,
or FDA, provided input on the Phase 3 trial design for tecarfarin, which was submitted by Espero, the previous owner of tecarfarin. We
intend to submit our Phase 3 trial design to the FDA using the same protocol that was submitted by Espero. Assuming the FDA accepts our
Phase 3 trial design, we intend to commence the Phase 3 pivotal trial in the second half of 2023. However, there can be no assurance that
the trial design will be accepted by the FDA. We are pursuing regulatory approval of tecarfarin as an individual treatment, although we
intend to evaluate, in consultation with the FDA, other potential uses in the future, including the treatment of patients with LVADs and
APS who require chronic anticoagulation.
In March 2019, the FDA granted orphan drug designation,
or ODD, for tecarfarin for the prevention of systemic thromboembolism of cardiac origin in patients with ESRD and AFib. The FDA grants
ODD status to drugs that are intended for the treatment, diagnosis, or prevention of rare diseases or conditions, which are defined as
a disease or condition that affects fewer than 200,000 people in the U.S. The ODD program provides a drug developer with certain benefits
and incentives, including a seven-year period of U.S. marketing exclusivity from the date of marketing authorization, waiver of FDA user
fees, and tax credits for clinical research. The granting of an orphan drug designation does not alter the FDA’s regulatory requirements
to establish safety and effectiveness of a drug through adequate and well-controlled studies to support approval and commercialization.
Furthermore, orphan drug designation does not indicate or guarantee FDA approval of the New Drug Application, or NDA, and we might not
receive exclusivity.
Tecarfarin was developed by researchers using
a retrometabolic drug design process which targets a different metabolic pathway than the most commonly prescribed drugs for the treatment
of thrombosis and AFib. “Drug metabolism” refers to the process by which a drug is inactivated by the body and rendered easier
to eliminate or to be cleared by the body. Most approved drugs, including warfarin, the only FDA-approved Vitamin K antagonists, or VKAs,
which is a prescribed drug for the treatment of thrombosis, are metabolized in the liver through a pathway known as the Cytochrome CYP450
system, or CYP450, by the enzymes known as CYP2C9 and CYP3A4. By using a different metabolic pathway, tecarfarin eliminates or minimizes
the CYP450 metabolism in the liver. Patients taking multiple medications that interact with CYP2C9, or CYP3A4 or those with impaired kidney
function, can experience an overload in the pathway, creating a bottleneck that often leads to insufficient clearance, which results in
a toxic build-up of one or more drugs. In some instances, patients taking multiple medications metabolized by the same CYP450 pathway
may experience decreased efficacy of one or more of the medications due to rapid metabolism or increased drug effect and/or toxicity due
to enzyme induction. Patient-specific genetic differences can also hinder drug clearance in the CYP450 pathway. Our product candidate
tecarfarin was designed to follow a metabolic pathway distinct from the CYP450 pathway and is metabolized by both CYP450 and non-CYP450
pathways. We believe this may allow elimination by large capacity and non-saturable tissue esterase pathways that exist throughout the
body rather than just in the liver.
Tecarfarin is an orphan designated, vitamin K
antagonist, oral, once-daily anticoagulant in the same drug class as warfarin designed for use in patients requiring chronic VKA anticoagulation,
to prevent systemic thromboembolism of cardiac origin in patients with ESRD and AFib. The prevailing treatment for thrombosis is with
an oral anticoagulant, either a VKA, like warfarin, or non-vitamin K oral anticoagulant (“NOAC”). VKAs block the production
of vitamin K-dependent blood clotting factors, such that the blood is “thinned,” preventing clots, while NOACs directly block
the activity of certain of these clotting factors. Tecarfarin, like warfarin, is a VKA.
Vitamin K epoxide Reductase Complex subunit 1
(VKORC1) is a significant enzyme for effective clotting. VKORC1 reduces vitamin K epoxide to its active form (Vitamin K), which is the
rate-limiting step in the physiological process of vitamin K recycling. Vitamin K serves as a cofactor for normal function of several
clotting/anticoagulation factors including Factors II, VII, IX and X and Proteins C, S, and Z. VKORC1 genetic deficiencies result in increased
sensitivity to VKAs, which results in an increase in the risk of significant hemorrhaging. We believe tecarfarin has similar potency for
VKORC1 inhibition as warfarin, but it is an investigational new drug, and we must demonstrate it is safe and effective for its proposed
indication.
AFib is the most common arrhythmia, with its incidence
and prevalence increasing over the last 20 years. AFib is associated with an approximate five-fold increased risk of stroke. The risk
of developing AFib increases in patients with CKD. According to 2021 estimates by the Centers for Disease Control and Prevention, or CDC,
approximately 15% of the U.S. adult population, or 37 million people, have CKD. An estimated 0.4% of people in the U.S. suffer from Stage
4 CKD and 0.1% of people in the U.S. have ESRD.
Patients with ESRD and AFib represent a spectrum
of disorders involving both the heart and kidneys (known as cardiorenal syndrome or CRS) in which acute or chronic dysfunction in one
organ may induce acute or chronic dysfunction in the other organ. These patients have typically been excluded from randomized clinical
trials because the approved therapies for AFib have metabolic profiles that may increase drug exposures thereby increasing the known risks
and challenges in managing these patients. The presence of either CKD or AFib, increases the risk of serious thromboembolic adverse clinical
outcomes, such as stroke and death. Antithrombotic therapy is typically recommended to decrease this risk in AFib patients, but there
are no approved treatment options for patients with ESRD and AFib. Warfarin may cause substantial harm in these patients. Low-dose apixaban
(Eliquis) was approved by the FDA for use in ESRD patients on hemodialysis based upon limited pharmacokinetic data by 8 subjects, despite
that randomized trials to date of apixaban versus warfarin for AFib excluded patients with severe and end-stage kidney disease. The RENAL-AF
(Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation) was terminated early in 2019 by its sponsor.
There are more than 809,000 Americans with ESRD,
with approximately 70% on dialysis, according to the United States Renal Data System. Approximately 150,000 ESRD patients also have AFib.
AFib nearly doubles the anticipated mortality and increases the stroke risk by approximately five-fold in these patients. There is evidence
that AFib is an independent risk factor for developing ESRD in CKD patients. Both diseases share common risk factors including hypertension,
diabetes, vascular disease, and advancing age. Cardiovascular disease contributes to more than half of all deaths among patients with
ESRD. According to the Annual Data Report published by the United States Renal Data System, total Medicare spending for patients with
ESRD reached $51 billion in 2019, accounting for approximately 7% of the Medicare paid claims costs.
We have licensed out the rights to tecarfarin
for several Asian markets including China, to Lee’s Pharmaceutical Holdings Limited, an integrated research-driven and market-oriented
biopharmaceutical publicly listed company based in Hong Kong with over 25 years’ experience in the pharmaceutical industry in China.
Lee’s Pharmaceutical Holdings Limited is developing tecarfarin as an anti-thrombotic for patients with mechanical heart valves.
In 2020 and 2021, Lee’s Pharmaceutical Holdings Limited completed two Phase 1 studies in China and Hong Kong and is currently preparing
for its Phase 2 trial.
As more fully set forth in our risk factors, we
are a clinical development biopharmaceutical company with a limited operating history. We have a history of operating losses and expect
to continue to incur substantial losses for the foreseeable future. Our cash and the proceeds of our initial public offering and the private
placement offering that we consummated in July 2023 will only fund our operations for a limited time. The proceeds from our financings
to date are insufficient to allow us to commence and complete our planned Phase 3 clinical trial and submit our NDA. We will need
to raise additional capital for the initiation of enrollment of patients and completion of the planned pivotal Phase 3 trial.
With respect to tecarfarin, we have two issued
U.S. patents directed to tecarfarin. While the patents currently expire in 2024, we expect to seek extensions of patent terms. In the
United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years
beyond the normal expiration of the patent, which is limited to the approved indication (or any additional indications approved during
the period of extension). We also intend to seek exclusivity for our proprietary product candidates through market and data exclusivity
granted by regulatory agencies in the United States and other countries. Further, as discussed above, the ODD program provides a drug
developer with certain benefits and incentives, including a seven-year period of U.S. marketing exclusivity from the date of marketing
authorization.
While we have engaged intellectual property counsel
to assist in protecting our patent ownership rights, to date, we have not had intellectual property counsel conduct a freedom to operate
analysis regarding our tecarfarin product. As a result, we cannot be certain that we will not be exposed to third party legal claims,
liabilities and/or litigation actions when we seek to develop, make and market products using our tecarfarin technology.
Clinical Trials
Tecarfarin has been evaluated in 11 human clinical
trials in over 1,003 individuals which includes eight Phase 1 trials, two Phase 2 trials and one Phase 2/3 trial evaluating the efficacy
and safety of tecarfarin.
In a Phase 2/3 randomized and blinded trial sponsored
by ARYx Therapeutics, Inc. in 2008, 607 patients with indications for chronic anticoagulation were treated with either tecarfarin or warfarin.
The Time in Therapeutic Range, or TTR, with tecarfarin was similar to that with well-managed warfarin and tecarfarin appeared to have
a favorable safety profile and be well tolerated with only 1.6% of the blinded tecarfarin subjects suffering from major bleeding and no
thrombotic events. When thrombotic and major bleeding events during the blinded period were combined, a numerical imbalance favoring tecarfarin
over warfarin was seen (warfarin 11 subjects, 3.6%; tecarfarin 5 subjects, 1.6%). The trial however did not meet its primary endpoint
as superiority of tecarfarin over warfarin as measured by TTR was not demonstrated.
In a subsequent Phase 1 study with 23 patients
with CKD sponsored by Armetheon, Inc. in 2016, the metabolism of warfarin was inhibited, but not tecarfarin. The safety of repeated dosing
of tecarfarin in CKD patients remained unknown. However, if the pharmacokinetic findings of this single-dose study are present with repeated
dosing, tecarfarin may lead to dosing that is more predictable than warfarin in CKD patients who require anticoagulation therapy.
Recent Events
Fast Track Designation
On January 13, 2023, the FDA designated as a Fast
Track development program the investigation of tecarfarin for the prevention of systemic thromboembolism of cardiac origin in patients
with ESRD and AFib. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions
and fill an unmet medical need.
Initial Public Offering
On January 24, 2023, we consummated our initial
public offering of 1,400,000 shares of our Common Stock at a public offering price of $5.00 per share, generating gross proceeds of $7,000,000.
Our shares of Common Stock commenced trading on the Nasdaq on January 20, 2023 under the symbol “CVKD.”
In connection with our initial public offering,
on January 19, 2023, we entered into the Underwriting Agreement with the Representative, a form of which was previously filed as an exhibit
to the Registration Statement, which was declared effective by the SEC on January 19, 2023. Pursuant to the Underwriting Agreement,
we agreed to issue to the underwriters the Representative’s Warrant to purchase an aggregate of 84,000 shares of our Common Stock,
which is equal to six percent (6%) of the shares of Common Stock sold in the initial public offering. Such Representative’s Warrant
has an exercise price of $6.00, which is equal to 120% of the public offering price of the Common Stock in the initial public offering.
In connection with the closing of the initial
public offering, we entered into separate indemnification agreements with each of our directors (we had previously entered into separate
indemnification agreements with each of our executive officers). The indemnification agreements, in addition to our Amended and Restated
Certificate of Incorporation and Amended and Restated Bylaws, require us to indemnify our directors, executive officers and certain controlling
persons to the fullest extent permitted by Delaware law.
Private Placement
On July 12, 2023, we entered into the Purchase
Agreement with the Investor Selling Stockholder pursuant to which we sold to the Investor Selling Stockholder in the Private Placement
priced at-the-market consistent with the rules of the Nasdaq Stock Market LLC, (i) an aggregate of 1,300,000 Shares, (ii) in lieu of additional
Shares, the Pre-Funded Warrants to purchase up to an aggregate of 2,985,715 shares of Common Stock, and (iii) accompanying Common Warrants
to purchase up to an aggregate of 4,285,715 shares of Common Stock. The combined purchase price of each Share and accompanying Common
Warrants is $1.75. The combined purchase price of each Pre-Funded Warrant and accompanying Common Warrants is $1.7499.
The Private Placement closed on July 14, 2023.
We received aggregate gross proceeds from the Private Placement of approximately $7.5 million, before deducting the placement agent commissions
and estimated offering expenses payable by us. We intend to use the net proceeds from the Private Placement for working capital purposes.
H.C.W. acted as the placement agent in the Private Placement and as part of its compensation we issued to designees of H.C.W. Placement
Agent Warrants to purchase up to 278,571 shares of Common Stock.
Appointment of Robert Lisicki To the
Board of Directors
On July 23, 2023, the Board of Directors increased
the size of the Board from four directors to five directors and appointed Robert Lisicki to serve as a Class II director to hold office
until the first annual meeting of stockholders to be held in 2024. Mr. Lisicki was also appointed to serve as a member of the Compensation
Committee of the Board of Directors and the Nominating and Corporate Governance Committee of the Board of Directors.
Results of Operations
Comparison of the Three Months Ended March 31, 2023 and period
from January 25, 2022 (inception) through March 31, 2022
The following table summarizes our results of
operations for the three months ended March 31, 2023 and the period from January 25, 2022 (inception) through March 31, 2022.
| |
Three Months Ended March 31, 2023 |
| |
January 25, 2022 (inception) through March 31, 2022 |
|
Operating expenses: | |
| |
|
General and administrative expenses | |
$ | 964,732 | | |
$ | 152,661 | |
Research and development expenses | |
| 3,235,317 | | |
| 17,860 | |
Depreciation expense | |
| 190 | | |
| - | |
Total operating expenses | |
| 4,200,239 | | |
| 170,521 | |
Loss from operations | |
| (4,200,239 | ) | |
| (170,521 | ) |
Other expense: | |
| | | |
| | |
Interest expense | |
| 3,534 | | |
| 2,081 | |
Interest expense, amortization of debt discount | |
| 13,567 | | |
| 2,508 | |
Change in fair value of derivative liabilities | |
| 216,095 | | |
| 1,538 | |
Loss on extinguishment of debt | |
| 740,139 | | |
| - | |
Total other expenses | |
| 973,335 | | |
| 6,127 | |
Net loss and comprehensive loss | |
$ | (5,173,574 | ) | |
$ | (176,648 | ) |
General and administrative expenses
General and administrative expenses were $964,732
for the three months ended March 31, 2023. General and administrative expenses included $439,304 of personnel-related expenses, $194,140
of stock-based compensation, $120,305 in professional fees, $49,278 of contract labor, and $161,705 of other expenses.
General and administrative expenses were $152,661
for the period January 25, 2022 (inception) to March 31, 2022. General and administrative expenses for this period included $37,661 of
personnel-related expenses and $115,000 in consulting fees.
Research and development expenses
Research and development expenses were $3,235,317
for the three months ended March 31, 2023. This included the issuance of 600,000 shares of Common Stock (valued at $3.0 million)
in January 2023 to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase Agreement. Research and development expenses
for the three months ended March 31, 2023 also included $92,256 of stock-based compensation and the remaining expenses related to personnel
costs.
Research and development expenses were $17,860
for the period January 25, 2022 (inception) to March 31, 2022. Research and development expenses consisted of $17,860 of transaction costs
which were expensed as in-process research and development.
Change in fair value of derivative liabilities
We determined that the redemption features in
the convertible notes that we issued in March 2022, June 2022, July 2022, August 2022 and September 2022 in the aggregate principal amount
of $1,125,000 contained rights and obligations for conversion contingent upon a potential future financing event or a change in control.
Thus, the embedded put options were bifurcated from the face value of the convertible notes and accounted for as derivative liabilities
to be remeasured at the end of each reporting period with the change in the fair value included in other expense, in the accompanying
statement of operations and comprehensive loss.
Concurrent with the closing of the IPO in January
2023, the note holders converted the debt into Common Stock, accordingly, the derivative financial liabilities were de-recognized and
reclassified to stockholders’ equity (deficit) on January 24, 2023.
The derivative liabilities were considered a level
3 fair value financial instrument and were remeasured up to January 24, 2023 which was the date of derecognition. We recorded a non-cash
charge of $216,095 in January 2023. This charge represented the increase in the fair value of the derivative liabilities since the previous
measurement date of December 31, 2022.
Loss on extinguishment of debt
We recorded a $740,139 loss on the extinguishment
of debt during the three months ended March 31, 2023. This loss represents the unamortized debt discount associated with the convertible
notes and the November promissory notes, which were settled concurrent with the IPO.
Results of Operations for the Fiscal Year
Ended December 31, 2022
The following table summarizes our results of
operations for the period January 25, 2022 (inception) to December 31, 2022.
| |
January 25, 2022 (inception) through December 31, 2022 |
|
Operating expenses: | |
|
General and administrative expenses | |
$ | 2,307,503 | |
Research and development expenses | |
| 392,859 | |
Depreciation expense | |
| 1,266 | |
Total operating expenses | |
| 2,701,628 | |
Loss from operations | |
| (2,701,628 | ) |
Other expense: | |
| | |
Interest expense | |
| 40,192 | |
Interest expense, amortization of debt discount | |
| 66,913 | |
Change in fair value of derivative liabilities | |
| 3,905,596 | |
Total other expenses | |
| 4,012,701 | |
Net loss and comprehensive loss | |
$ | (6,714,329 | ) |
General and administrative expenses
General and administrative expenses were $2,307,503
for the period January 25, 2022 (inception) to December 31, 2022. General and administrative expenses included $791,247 of stock-based
compensation, $936,437 of personnel-related expenses, $180,536 of contract labor, $115,000 in consulting fees, $30,871 of patent renewal
fees, $68,226 in accounting fees, and $185,186 of other expenses.
Research and development expenses
Research and development expenses were $392,859
for the period January 25, 2022 (inception) to December 31, 2022. Research and development expenses included $200,000 of acquired intangible
assets, $20,095 of transaction costs which are expensed as in-process research and development, $136,802 of stock-based compensation,
and $35,962 of consulting services.
Change in fair value of derivative liabilities
We determined that the redemption features in
the convertible notes contained rights and obligations for conversion contingent upon a potential future financing event or a change in
control. Thus, the embedded put options were bifurcated from the face value of the convertible notes and accounted for as derivative liabilities
to be remeasured at the end of each reporting period with the change in the fair value included in other expense, in the accompanying
statement of operations and comprehensive loss.
The derivative liabilities were considered a level
3 fair value financial instrument and were measured at the reporting period ended December 31, 2022. We recorded a non-cash charge of
$3,905,596 for the period January 25, 2022 (inception) to December 31, 2022. This charge represented the increase in the fair value of
the derivative liabilities since the issuance of the respective financial instruments.
Concurrent with the closing of the initial public
offering in January 2023, the note holders converted the debt into Common Stock, accordingly, the derivative financial liabilities will
be de-recognized and reclassified to stockholders’ equity (deficit) on January 24, 2023.
Liquidity and Capital Resources
Since inception, we have incurred losses and negative
cash flows from operations. To date, we have funded our operations from the proceeds of the sale of convertible notes, and the nonconvertible
notes and warrants issued in November 2022, as well as our recently completed IPO in January 2023 and our private placement transaction
that we consummated in July 2023. We had a net loss of $5,173,574 for the three months ended March 31, 2023 which included $4,256,475
of non-cash expenses. We had a net loss of $6,714,329 for the period January 25, 2022 (inception) to December 31, 2022 which included
$4,901,824 of non-cash expenses. Cash used in operating activities for the three months ended March 31, 2023 totaled $1,412,794. Cash
used in operations for the period January 25, 2022 (inception) to December 31, 2022 totaled $1,204,770. As of March 31, 2023, we
had cash of approximately $4.0 million and no debt. As of July 19, 2023 we had cash and cash equivalents of approximately $9.7 million.
Our current cash is sufficient to fund our operations for at least the twelve months , however, we expect to require additional funding
to commence and complete our planned Phase 3 clinical trial and submit our NDA, the cost of which we anticipate will be approximately
$45 million. In order to fund the commencement and completion of our Phase 3 clinical trial, we intend to raise additional funds
through equity and debt financings as well as potential partnering relationships. However, there can be no assurance that we will be able
to complete any additional financings on terms acceptable to the Company or at all. If we are unable to raise additional funding to meet
our working capital needs in the future, we will be forced to delay or reduce the scope of our research programs and/or limit or cease
our operations.
Cash Flows
The following table summarizes our cash flows
for the three months ended March 31, 2023, for the period from January 25, 2022 (inception) to March 31, 2022, and for the period from
January 25, 2022 (inception to December 31, 2022):
| |
Three Months Ended March 31, 2023 |
| |
January 25, 2022 (inception) through March 31, 2022 |
| |
January 25, 2022
(Inception) to December 31, 2022
|
|
Cash used in operating activities | |
$ | (1,412,794 | ) | |
$ | (43,699 | ) | |
| (1,204,770 | ) |
Cash used in investing activities | |
| - | | |
| - | | |
| (2,279 | ) |
Cash provided by financing activities | |
| 5,408,575 | | |
| 506,040 | | |
| 1,239,635 | |
Net increase in cash | |
| 3,995,781 | | |
| 462,341 | | |
| 32,586 | |
Cash, beginning of period | |
| 32,586 | | |
| - | | |
| — | |
Cash, end of period | |
$ | 4,028,367 | | |
$ | 462,341 | | |
| 32,586 | |
Operating activities
During the three months ended March 31, 2023,
cash used in operating activities was $1,412,794. Net loss adjusted for the non-cash items as detailed on the statement of cash flows,
used $917,099 in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $495,695
in cash primarily from a $285,330 decrease in accounts payable and a $604,945 decrease in accrued liabilities partially offset by a $672,295
decrease in deferred equity offering costs.
During the period from January 25, 2022 (inception)
to March 31, 2022, cash used in operating activities was $43,699. Net loss adjusted for the non-cash items, as detailed on the statement
of cash flows, used $172,602 in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows,
provided $128,903 in cash primarily from a $117,083 increase in accrued liabilities.
During the period January 25, 2022 (inception)
to December 31, 2022, cash used in operating activities was $1,204,770. Net loss adjusted for the non-cash items as detailed on the statement
of cash flows used $1,812,505 in cash, and the changes in operating assets and liabilities as detailed on the statement of cash flows
provided $607,735 in cash primarily from a $404,897 increase in accounts payable and an $863,622 increase in accrued liabilities partially
offset by a $672,295 increase in deferred equity offering costs.
Financing activities
During the three months ended March 31, 2023,
net cash provided by financing activities totaled $5,408,575 as we completed our IPO of 1,400,000 shares of our Common Stock at a public
offering price of $5.00 per share, generating gross proceeds of $7,000,000 and net proceeds of $5,408,575. We also received $250,000 from
the exercise of warrants that we issued in November 2022, which proceeds were used to repay the notes that were issued in November, with
accrued interest on the notes being paid in cash.
During the period January 25, 2022 (inception)
to March 31, 2022, net cash provided by financing activities was $506,490, primarily consisting of the $498,540 of net proceeds from the
issuance of a convertible note in March 2022.
During the period January 25, 2022 (inception)
to December 31, 2022, net cash provided by financing activities was $1,239,635, primarily consisting of the $1,011,964 of net proceeds
from the issuance of convertible notes and $219,721 of net proceeds from the issuance of a non-convertible promissory note and warrants.
Critical Accounting Estimates
This discussion and analysis of our financial
condition and results of operations are based on our financial statements, which have been prepared in accordance with generally accepted
accounting principles in the United States, or GAAP. The preparation of these financial statements requires us to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at
the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based
on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.
Actual results may differ from these estimated under different assumptions or conditions. While our significant accounting policies are
described in more detail in the notes to our financial statements, we believe that the following accounting policies are critical to understanding
our historical and future performance, as these policies relate to the more significant areas involving management’s judgements
and estimates.
Acquisitions
We evaluate acquisitions of assets and other similar
transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first
applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single
identifiable asset or group of similar identifiable assets. If so, the transaction is accounted for as an asset acquisition. If not, further
determination is required as to whether or not we have acquired inputs and processes that have the ability to create outputs, which would
meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition
is a business combination or an acquisition of assets.
Acquisitions meeting the definition of business
combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the
net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair
values of the net assets acquired is recorded as goodwill.
For asset acquisitions, a cost accumulation model
is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition.
We also evaluate which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted
for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities
assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an
asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative
fair values. When a transaction accounted for as an asset acquisition includes an in-process research and development (“IPR&D”)
asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development
project. For an IPR&D asset to have an alternative future use: (a) we must reasonably expect that we will use the asset acquired
in the alternative manner and anticipate economic benefit from that alternative use, and (b) our use of the asset acquired is not
contingent on further development of the asset subsequent to the acquisition date (that is, the asset can be used in the alternative manner
in the condition in which it existed at the acquisition date). Otherwise, amounts allocated to IPR&D that have no alternative use
are expensed to research and development. Asset acquisitions may include contingent consideration arrangements that encompass obligations
to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration is not recognized
until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated
to the assets acquired on a relative fair value basis.
Research and Development Expenses
Research and development costs are expensed as
incurred and consist of fees paid to other entities that conduct certain research and development activities on our behalf. Acquired intangible
assets are expensed as research and development costs if, at the time of payment, the technology is under development; is not approved
by the FDA or other regulatory agencies for marketing; has not reached technical feasibility; or otherwise has no foreseeable alternative
future use. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities
are capitalized and then expensed as the related goods are delivered or the services are performed.
Derivative Financial Instruments
We evaluate all of our agreements to determine
if such instruments have derivatives or contain features that qualify as embedded derivatives. We account for certain redemption features
that are associated with convertible notes as liabilities at fair value and adjust the instruments to their fair value at the end of each
reporting period. Derivative financial liabilities are initially recorded at fair value, with gains and losses arising from changes in
the fair value recognized in other income (expense) in the accompanying statements of operations and comprehensive loss for each reporting
period while such instruments are outstanding. The embedded derivative liability is valued using a probability-weighted expected return
model. If we repay the note holders or if, during the next round of financing, the note holders convert the debt into equity, the derivative
financial liability will be de-recognized on that date. Derivative instrument liabilities are classified in the balance sheet as current
or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the
balance sheet date.
Stock-Based Compensation
We measure our stock-based awards granted to employees,
consultants and directors based on the estimated fair values of the awards and recognize the compensation over the requisite service period.
We use the Black-Scholes option-pricing model to estimate the fair value of our stock option awards. Stock-based compensation is recognized
using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is reduced by forfeitures.
We account for forfeitures as they occur.
Use of Estimates
The preparation of financial statements in conformity
with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting
period. Significant estimates and assumptions made in the accompanying financial statements include but are not limited to the fair value
of financial instruments, the fair value of Common Stock prior to our IPO, deferred tax assets and valuation allowance, income tax uncertainties,
and certain accruals. We evaluate our estimates and assumptions on an ongoing basis using historical experience and other factors and
adjusts those estimates and assumptions when facts and circumstances change. Actual results could differ from those estimates.
OFF-BALANCE SHEET ARRANGEMENTS
We did not have during the period presented, and
we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.
JOBS Act
The JOBS Act permits an emerging growth company
such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public
companies until those standards would otherwise apply to private companies. We have elected to avail ourselves of the extended transition
period for complying with new or revised financial accounting standards.
We will remain an emerging growth company until
the earliest of (i) the last day of our first fiscal year in which we have total annual gross revenues of $1.235 billion
or more; (ii) the date on which we are deemed to be a “large accelerated filer” under the rules of the SEC with at least
$700.0 million of outstanding equity securities held by non-affiliates; (iii) the date on which we have issued more than $1.0 billion
in non-convertible debt securities during the previous three years; or (iv) the last day of our fiscal year following
the fifth anniversary of the date of the completion of this offering.
BUSINESS
We are focused on developing tecarfarin, a novel
therapy with orphan drug indication, designed for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients
with end-stage renal disease, or ESRD, and atrial fibrillation (irregular heartbeat), or AFib. We secured the rights to tecarfarin on
April 1, 2022 via an asset purchase agreement from HESP LLC, a wholly owned subsidiary of Horizon Technology Finance Corporation. HESP
LLC acquired the assets of Espero BioPharma, Inc., or Espero, including tecarfarin, in an assignment for the benefit of creditors in which
the creditor, Horizon Technology Finance Corporation and Horizon Credit II LLC (collectively, Horizon), a secured lender of Espero, designated
HESP LLC as the assignee of Espero’s assets.
Tecarfarin is an anticoagulant that uses a drug
design process which targets a different pathway than the most commonly prescribed drugs used in the treatment of thrombosis and AFib.
Tecarfarin has been evaluated in eleven (11) human clinical trials conducted by its previous owners and other third parties in over 1,003
individuals (269 patients were treated for at least six months and 129 patients were treated for one year or more). In Phase 1, Phase
2 and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic
kidney disease, or CKD. In the Phase 2/3 trial, EMBRACE-AC, the largest tecarfarin trial with 607 patients having completed it, only 1.6%
of the blinded tecarfarin subjects suffered from major bleeding and there were no thrombotic events. Five patients died during the trial,
but only one death due to intracerebral hemorrhage was considered to be possibly related to the tecarfarin.
In 2019, the United States Food and Drug Administration,
or FDA, provided input on the Phase 3 trial design for tecarfarin, which was submitted by Espero, the previous owner of tecarfarin. We
intend to submit our Phase 3 trial design to the FDA using the same protocol that was submitted by Espero. Assuming the FDA accepts our
Phase 3 trial design, we intend to commence the Phase 3 pivotal trial in the first half of 2024. However, there can be no assurance that
the trial design will be accepted by the FDA. We are pursuing regulatory approval of tecarfarin as an individual treatment, although we
intend to evaluate, in consultation with the FDA, other potential uses in the future, including the treatment of patients with Left Ventricular
Assist Devices (LVADs) and antiphospholipid syndrome (APS) who require chronic anticoagulation.
In March 2019, the FDA granted orphan drug designation,
or ODD, for tecarfarin for the prevention of systemic thromboembolism of cardiac origin in patients with ESRD and AFib. The FDA grants
ODD status to drugs that are intended for the treatment, diagnosis, or prevention of rare diseases or conditions, which are defined as
a disease or condition that affects fewer than 200,000 people in the U.S. The ODD program provides a drug developer with certain benefits
and incentives, including a seven-year period of U.S. marketing exclusivity from the date of marketing authorization, waiver of FDA user
fees, and tax credits for clinical research. The granting of an orphan drug designation does not alter the FDA’s regulatory requirements
to establish safety and effectiveness of a drug through adequate and well-controlled studies to support approval and commercialization.
Furthermore, orphan drug designation does not indicate or guarantee FDA approval of the New Drug Application, or NDA, and we might not
receive exclusivity.
Tecarfarin was developed by researchers using
a retrometabolic drug design process which targets a different metabolic pathway than the most commonly prescribed drugs for the treatment
of thrombosis and AFib. “Drug metabolism” refers to the process by which a drug is inactivated by the body and rendered easier
to eliminate or to be cleared by the body. Most approved drugs, including warfarin, the only FDA-approved Vitamin K antagonists, or VKAs,
which is a prescribed drug for the treatment of thrombosis, are metabolized in the liver through a pathway known as the Cytochrome CYP450
system, or CYP450, by the enzymes known as CYP2C9 and CYP3A4. By using a different metabolic pathway, tecarfarin eliminates or minimizes
the CYP450 metabolism in the liver. Patients taking multiple medications that interact with CYP2C9, or CYP3A4 or those with impaired kidney
function, can experience an overload in the pathway, creating a bottleneck that often leads to insufficient clearance, which results in
a toxic build-up of one or more drugs. In some instances, patients taking multiple medications metabolized by the same CYP450 pathway
may experience decreased efficacy of one or more of the medications due to rapid metabolism or increased drug effect and/or toxicity due
to enzyme induction. Patient-specific genetic differences can also hinder drug clearance in the CYP450 pathway. Our product candidate
tecarfarin was designed to follow a metabolic pathway distinct from the CYP450 pathway and is metabolized by both CYP450 and non-CYP450
pathways. We believe this may allow elimination by large capacity and non-saturable tissue esterase pathways that exist throughout the
body rather than just in the liver.
Tecarfarin is an orphan designated, vitamin K
antagonist, oral, once-daily anticoagulant in the same drug class as warfarin designed for use in patients requiring chronic VKA anticoagulation,
to prevent systemic thromboembolism of cardiac origin in patients with ESRD and AFib. The prevailing treatment for thrombosis is with
an oral anticoagulant, either a VKA, like warfarin, or non-vitamin K oral anticoagulant (“NOAC”). VKAs block the production
of vitamin K-dependent blood clotting factors, such that the blood is “thinned,” preventing clots, while NOACs directly block
the activity of certain of these clotting factors. Tecarfarin, like warfarin, is a VKA.
Vitamin K epoxide Reductase Complex subunit 1
(VKORC1) is a significant enzyme for effective clotting. VKORC1 reduces vitamin K epoxide to its active form (Vitamin K), which is the
rate-limiting step in the physiological process of vitamin K recycling. Vitamin K serves as a cofactor for normal function of several
clotting/anticoagulation factors including Factors II, VII, IX and X and Proteins C, S, and Z. VKORC1 genetic deficiencies result in increased
sensitivity to VKAs, which results in an increase in the risk of significant hemorrhaging. We believe tecarfarin has similar potency for
VKORC1 inhibition as warfarin, but it is an investigational new drug, and we must demonstrate it is safe and effective for its proposed
indication.
AFib is the most common arrhythmia, with its incidence
and prevalence increasing over the last 20 years. AFib is associated with an approximate five-fold increased risk of stroke. The risk
of developing AFib increases in patients with CKD. According to 2021 estimates by the Centers for Disease Control and Prevention, or CDC,
approximately 15% of the U.S. adult population, or 37 million people, have CKD. An estimated 0.4% of people in the U.S. suffer from Stage
4 CKD and 0.1% of people in the U.S. have ESRD.
Patients with ESRD and AFib represent a spectrum
of disorders involving both the heart and kidneys (known as cardiorenal syndrome or CRS) in which acute or chronic dysfunction in one
organ may induce acute or chronic dysfunction in the other organ. These patients have typically been excluded from randomized clinical
trials because the approved therapies for AFib have metabolic profiles that may increase drug exposures thereby increasing the known risks
and challenges in managing these patients. The presence of either CKD or AFib, increases the risk of serious thromboembolic adverse clinical
outcomes, such as stroke and death. Antithrombotic therapy is typically recommended to decrease this risk in AFib patients, but there
are no approved treatment options for patients with ESRD and AFib. Warfarin may cause substantial harm in these patients. Low-dose apixaban
(Eliquis) was approved by the FDA for use in ESRD patients on hemodialysis based upon limited pharmacokinetic data by 8 subjects, despite
that randomized trials to date of apixaban versus warfarin for AFib excluded patients with severe and end-stage kidney disease. The RENAL-AF
(Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation) was terminated early in 2019 by its sponsor.
There are more than 809,000 Americans with ESRD,
with approximately 70% on dialysis, according to the United States Renal Data System. Approximately 150,000 ESRD patients also have AFib.
AFib nearly doubles the anticipated mortality and increases the stroke risk by approximately five-fold in these patients. There is evidence
that AFib is an independent risk factor for developing ESRD in CKD patients. Both diseases share common risk factors including hypertension,
diabetes, vascular disease, and advancing age. Cardiovascular disease contributes to more than half of all deaths among patients with
ESRD. According to the Annual Data Report published by the United States Renal Data System, total Medicare spending for patients with
ESRD reached $51 billion in 2019, accounting for approximately 7% of the Medicare paid claims costs.
We have licensed out the rights to tecarfarin
for several Asian markets including China, to Lee’s Pharmaceutical Holdings Limited, an integrated research-driven and market-oriented
biopharmaceutical publicly listed company based in Hong Kong with over 25 years’ experience in the pharmaceutical industry in China.
Lee’s Pharmaceutical Holdings Limited is developing tecarfarin as an anti-thrombotic for patients with mechanical heart valves.
In 2020 and 2021, Lee’s Pharmaceutical Holdings Limited completed two Phase 1 studies in China and Hong Kong and is currently preparing
for its Phase 2 trial.
* |
The rights to tecarfarin for several Asian markets including China have been out licensed to Lee’s Pharmaceutical, a publicly listed company based in Hong Kong, who is developing tecarfarin as an anti-thrombotic for patients with mechanical heart valves. |
Members of our management team have extensive
experience in drug discovery, development and commercialization and have held senior leadership positions at a number of pharmaceutical
and biotechnology companies. We also benefit from our broad network of established relationships with leaders in the industry and medical
community.
As more fully set forth in our risk factors, we
are a clinical development biopharmaceutical company with a limited operating history. We have a history of operating losses and expect
to continue to incur substantial losses for the foreseeable future. Our cash and the proceeds from our initial public offering and the
private placement offering that we consummated in July 2023 will only fund our operations for a limited time. The proceeds from our financings
to date are insufficient to allow us to fully fund our planned pivotal Phase 3 clinical trial. We will need to raise additional capital
for the initiation of enrollment of patients and completion of the planned pivotal Phase 3 trial.
With respect to tecarfarin, we have two issued
U.S. patents directed to tecarfarin. While the patents currently expire in 2024, we expect to seek extensions of patent terms. In the
United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years
beyond the normal expiration of the patent, which is limited to the approved indication (or any additional indications approved during
the period of extension). We also intend to seek exclusivity for our proprietary product candidates through market and data exclusivity
granted by regulatory agencies in the United States and other countries. Further, as discussed above, the ODD program provides a drug
developer with certain benefits and incentives, including a seven-year period of U.S. marketing exclusivity from the date of marketing
authorization.
While we have engaged intellectual property counsel
to assist in protecting our patent ownership rights, to date, we have not had intellectual property counsel conduct a freedom to operate
analysis regarding our tecarfarin product. As a result, we cannot be certain that we will not be exposed to third party legal claims,
liabilities and/or litigation actions when we seek to develop, make and market products using our tecarfarin technology.
Clinical Trials
Tecarfarin has been evaluated in 11 human clinical
trials in over 1,003 individuals which includes eight Phase 1 trials, two Phase 2 trials and one Phase 2/3 trial evaluating the efficacy
and safety of tecarfarin.
In a Phase 2/3 randomized and blinded trial sponsored
by ARYx Therapeutics, Inc. in 2008, 607 patients with indications for chronic anticoagulation were treated with either tecarfarin or warfarin.
The Time in Therapeutic Range, or TTR, with tecarfarin was similar to that with well-managed warfarin and tecarfarin appeared to have
a favorable safety profile and be well tolerated with only 1.6% of the blinded tecarfarin subjects suffering from major bleeding and no
thrombotic events. When thrombotic and major bleeding events during the blinded period were combined, a numerical imbalance favoring tecarfarin
over warfarin was seen (warfarin 11 subjects, 3.6%; tecarfarin 5 subjects, 1.6%). The trial however did not meet its primary endpoint
as superiority of tecarfarin over warfarin as measured by TTR was not demonstrated.
In a subsequent Phase 1 study with 23 patients
with CKD sponsored by Armetheon, Inc. in 2016, the metabolism of warfarin was inhibited, but not tecarfarin. The safety of repeated dosing
of tecarfarin in CKD patients remained unknown. However, if the pharmacokinetic findings of this single-dose study are present with repeated
dosing, tecarfarin may lead to dosing that is more predictable than warfarin in CKD patients who require anticoagulation therapy.
Recent Events
Fast Track Designation
On January 13, 2023, the FDA designated as a Fast
Track development program the investigation of tecarfarin for the prevention of systemic thromboembolism of cardiac origin in patients
with ESRD and AFib. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions
and fill an unmet medical need.
Initial Public Offering
On January 24, 2023, we completed our initial
public offering of 1,400,000 shares of our Common Stock at a public offering price of $5.00 per share, generating gross proceeds of $7,000,000.
Our shares of Common Stock commenced trading on the Nasdaq on January 20, 2023 under the symbol “CVKD.”
In connection with our initial public offering,
on January 19, 2023, we entered into the Underwriting Agreement with Boustead Securities, LLC, as representative of the underwriters (the
“Representative”), a form of which was previously filed as an exhibit to the IPO Registration Statement. Pursuant to
the Underwriting Agreement, we agreed to issue to a five-year Representative’s Warrant to purchase an aggregate of 84,000 shares
of our Common Stock, which is equal to six percent (6%) of the shares of Common Stock sold in the initial public offering. Such Representative’s
Warrant has an exercise price of $6.00, which is equal to 120% of the public offering price of the Common Stock in the initial public
offering.
In connection with the closing of the initial
public offering, we entered into separate indemnification agreements with each of our directors (we had previously entered into separate
indemnification agreements with each of our executive officers). The indemnification agreements, in addition to our Amended and Restated
Certificate of Incorporation and Amended and Restated Bylaws, require us to indemnify our directors, executive officers and certain controlling
persons to the fullest extent permitted by Delaware law.
Private Placement
On July 12, 2023, we entered into the Purchase
Agreement with the Investor Selling Stockholder pursuant to which we sold to the Investor Selling Stockholder in the Private Placement
priced at-the-market consistent with the rules of the Nasdaq Stock Market LLC, (i) an aggregate of 1,300,000 Shares, (ii) in lieu of additional
Shares, the Pre-Funded Warrants to purchase up to an aggregate of 2,985,715 shares of Common Stock, and (iii) accompanying Common Warrants
to purchase up to an aggregate of 4,285,715 shares of Common Stock. The combined purchase price of each Share and accompanying Common
Warrants is $1.75. The combined purchase price of each Pre-Funded Warrant and accompanying Common Warrants is $1.7499.
The Private Placement closed on July 14, 2023.
We received aggregate gross proceeds from the Private Placement of approximately $7.5 million, before deducting the placement agent commissions
and estimated offering expenses payable by us. We intend to use the net proceeds from the Private Placement for working capital purposes.
H.C.W acted as the placement agent in the Private Placement and as part of its compensation we issued to designees of H.C.W. Placement
Agent Warrants to purchase up to 278,571 shares of Common Stock.
Appointment of Robert Lisicki To the
Board of Directors
On July 23, 2023, the Board of Directors increased
the size of the Board from four directors to five directors and appointed Robert Lisicki to serve as a Class II director to hold office
until the first annual meeting of stockholders to be held in 2024. Mr. Lisicki was also appointed to serve as a member of the Compensation
Committee of the Board of Directors and the Nominating and Corporate Governance Committee of the Board of Directors.
Our Strategy
Our goal is to build a biopharmaceutical company
with a foundation of product candidates that significantly advance patient care in cardiovascular diseases. Key elements of our strategy
are as follows:
|
● |
Complete the clinical development of and seek FDA approval for tecarfarin. We intend to initiate our pivotal Phase 3 clinical trial in the first half of 2024, subject to funding from additional financings, which we believe will be our remaining pivotal trial based upon the latest feedback that the prior owner of tecarfarin had with the FDA in 2019. ACTOR AF: Anti-Coagulation with Tecarfarin on Outcomes in Renal disease and Atrial Fibrillation is designed as a Phase 3, 492-patient, Randomized, Double-Blind, Placebo-Controlled Outcomes Study of Tecarfarin vs. Placebo in Subjects with End-Stage Renal Disease and Atrial Fibrillation not Currently Treated with Chronic Oral Anticoagulation. If we are able to complete the Phase 3 clinical trial and we are able to obtain FDA approval of our NDA, we believe tecarfarin can be an alternative treatment for patients who are currently without an approved treatment. |
|
● |
If we obtain FDA approval of our NDA for our first indication, we intend to seek to expand the label for tecarfarin through a supplemental NDA. We intend to explore the full potential of tecarfarin in additional indications, including the treatment of patients with LVADs, APS and MHVs who require chronic anticoagulation. An LVAD is an implantable pump attached to the heart, connecting the apex of the left ventricle to the ascending aorta. LVADs are intended to treat patients suffering from advanced heart failure. APS is an autoimmune disorder characterized by an increased tendency to form abnormal blood clots, which can form in nearly any blood vessel in the body, and which can also cause miscarriages in women. MHVs are a type of prosthetic heart valve constructed of durable materials such as titanium or carbon that can potentially last a patient’s lifetime. Despite their high durability, MHVs are associated with an increased risk of developing blood clots that may interrupt blood flow and travel to various organs (thromboembolism). Oral anticoagulation therapy with a vitamin K antagonist (warfarin) continues to be the recommended treatment option for patients implanted with an MHV based on the 2014 American Heart Association/American College of Cardiology Guidelines. |
|
● |
We intend to partner and/or in-license and/or acquire clinical and pre-clinical stage cardiovascular products to augment our current pipeline which consists of one investigational product. |
|
● |
Create a commercial infrastructure for our product candidates. If tecarfarin is approved by the FDA, we intend to expand our commercial infrastructure and hire and train a focused and dedicated specialty cardiorenal salesforce which we believe can efficiently cover the top prescribing physicians and approximately 3,000 anticoagulation clinics in the U.S., which presently monitor patients on warfarin. If approved, we intend to initially target our tecarfarin commercialization efforts at the two largest dialysis providers in the U.S., DaVita Kidney Care and Fresenius Medical Care. DaVita maintains more than 2,800 brick-and-mortar dialysis centers in the U.S., while Fresenius’ North America subsidiary owns more than 2,500 on the continent — together accounting for more than 70% of the entire U.S. market. |
Retrometabolic Drug Design Process
We utilize a retrometabolic drug design process
to design product candidates that follow a metabolic pathway that we believe will confer significant clinical advantages over existing
drugs metabolized by the CYP450 pathway. “Drug metabolism” refers to the process by which a drug is inactivated by the body
and rendered easier to eliminate or to be cleared by the body. Most approved drugs are metabolized in the liver through the CYP450 pathway
by the enzymes known as CYP2C9 and CYP3A4. The CYP450 metabolic pathway has limited capacity, and patients taking multiple medications
that interact with CYP2C9, or those with impaired kidney function, can experience an overload in the pathway, creating a bottleneck causing
insufficient clearance, which results in a toxic build-up of one or more drugs. In some instances, patients taking multiple medications
that interact with CYP2C9 may also experience that a drug is eliminated too quickly from the body, reducing the efficacy of the drug.
Patient-specific genetic differences can also hinder drug clearance in the CYP450 pathway. Our product candidates were designed so
that they follow a metabolic pathway distinct from or in addition to the CYP450 pathway, eliminating or minimizing the CYP450 metabolism
by the liver, and are instead or additionally eliminated by large capacity and non-saturable tissue esterase pathways that exist
throughout the body rather than just in the liver. We believe that the use of these alternative pathways can minimize the impact of drug-to-drug interactions,
impaired kidney function and genetic variability, on the metabolism of our drugs, thereby ultimately minimizing clearance-related safety
issues.
As part of the retrometabolic design process,
we first design a metabolite, which we refer to as the “ideal metabolite,” that is non-toxic, pharmacologically inactive,
water soluble and rapidly eliminated from the body through a pathway distinct from the CYP450 pathway. This ideal metabolite becomes the
foundation upon which we develop a limited series of potential molecular drug candidates that have the same pharmacology and function
as the original drug. We then test the potential drug candidates we have created preclinically to assess whether the candidates have the
same activity as the original drug and to ensure the candidates break down properly to the ideal metabolite. This process allows us to
identify the drug candidates that would be best suited for further clinical development.
By designing drugs that break down to the ideal
metabolite, and accordingly, are not cleared through the CYP450 pathway, we create product candidates that we believe would reduce many
of the safety risks and complications that patients experience with drugs that are cleared through the CYP450 pathway. As a result, we
believe there may be better compliance with a tecarfarin treatment regimen, if approved by FDA, which may also result in increased efficacy
for the patients taking our drug product candidates.
Our Investigational Product Candidate
Tecarfarin for Use in Patients with ESRD
and AFib
ESRD and AFib Current Treatment Landscape
Thrombosis is the formation or presence of a blood
clot (a thrombus) within a blood vessel that blocks normal blood flow. A formed thrombus can detach from the vessel or heart atrium wall,
resulting in a thromboembolism that causes a blockage of the blood flow to vital organs, such as the brain, heart and lungs. According
to the CDC, each year, approximately 800,000 people in the U.S. experience a new or recurrent stroke, of which approximately 87%
are ischemic strokes, which are caused by either a thrombotic event or embolism, in which blood flow to the brain is blocked. In addition,
the CDC estimates that as many as 900,000 people in the U.S. could be affected by venous thromboembolism (blood clotting in the veins)
or a pulmonary embolism (blood clotting in the lungs) each year.
The American Heart Association estimates that
5 million Americans suffer from heart-valve disease, which forces the heart to work harder to pump blood and can lead to heart
failure and sudden death. The disease can be present at birth or result from infections, heart attacks or other heart conditions. Further,
more than 182,000 heart valve replacements are performed every year in the U.S. Mechanical heart valves also create a risk of thrombotic
events.
The prevailing treatment for patients at risk
of thrombosis is an oral anticoagulant, or OAC, of which there are two common types: vitamin K antagonists, or VKAs, and non-vitamin K
oral anticoagulants, or NOACs.
Vitamin K Antagonists: Warfarin
Vitamin K antagonists, or VKAs, are substances
that block the production of vitamin K-dependent blood clotting factors such that the blood is “thinned,” preventing
clots. VKAs are used as anticoagulants in the treatment of thrombosis. For patients treated with a VKA, the international normalized ratio,
or INR, a system established by the World Health Organization and the International Committee on Thrombosis and Hemostasis, is a commonly
available, inexpensive measure of the body’s coagulation status. Each VKA patient’s dose must be individualized, based on
a target range for his or her INR test. The percentage of time that a patient’s INR is maintained within his or her target range
is known as the time in therapeutic range, or TTR. TTR is a well-established FDA metric used to evaluate anticoagulation control
(safety and efficacy) of a VKA based on prothrombin time and the INR. When used as a therapy, VKAs are titrated to a patient’s
individual INR range and that patient is expected to visit a clinic for regular INR monitoring. A higher TTR reflects better anticoagulation
control and is related to improved clinical outcomes, including rates of death, bleeding, myocardial infarction, stroke and systemic embolism,
and a TTR measure of ≥ 70% is generally accepted as the goal for stable anticoagulation with a VKA. When patients are above their
individual INR range, they are at higher risk for bleeding, due to reduced clotting ability, while patients are below their target INR
range are at higher risk for thrombotic events. Potential benefits of monitoring INR include ascertaining patient compliance with their
drug treatment regimen, the ability to detect when dose adjustments are needed and maintaining safety and efficacy of the drug treatment.
TTR is predictive of adverse events, including mortality, stroke and myocardial infarction.
As depicted in the chart below, higher TTR is
generally correlated with higher survival rates.
Source: Currie et al. Heart 2006 (92) 196-200
Higher TTR levels are also associated with better
kidney functioning, as measured by estimated glomerular filtration rate (eGFR), as reported by the Journal of the American Heart Association
in 2017.
VKAs are reversible, meaning that in cases of
over-anticoagulation, vitamin K or fresh frozen plasma, or a combination, can be administered to bring patients back down into their INR
range.
Warfarin is currently one VKA treatment option
for thrombosis in the U.S. and has been in use since the 1950s. However, as reported by the National Center for Biotechnology Information,
there are many adverse events associated with warfarin, including bleeding, skin necrosis and hair loss, and warfarin has been reported
as number three on the list of drugs implicated in adverse effects causing hospital admission due to its many drug-to-drug interactions.
Due to these side effects and the increasing use of NOACs, the use of warfarin has decreased during the last decade.
Limitations of Warfarin Treatment
Warfarin has significant safety risks stemming
from its metabolic process, including its elimination pathway. Other drawbacks of warfarin are widely recognized such as narrow therapeutic
range, slow onset and offset of action causing difficulty to manage during peri-invasive procedures, and multiple drug and food interactions.
Warfarin’s efficacy and safety profile are
affected by its metabolism and elimination characteristics and various interactions with other drugs. Warfarin is metabolized through
the CYP450 pathway, primarily by the CYP2C9 enzyme, and approximately 15% of clinically used drugs are metabolized by the same enzyme,
including certain anticoagulants, antiplatelets and non-steroidal anti-inflammatory drugs, or NSAIDS. Patients taking warfarin
and on CYP2C9 interacting drugs may experience either or both of, warfarin being eliminated by the body too quickly, thereby decreasing
its anticoagulation effect, or warfarin being eliminated by the body too slowly, resulting in excessive and dangerous thinning of the
blood. In both of these situations, increased monitoring is required and dose adjustments are often necessary. Patients who take both
warfarin and these CYP2C9 interacting drugs also have an increased risk of being outside their individual INR target range and experiencing
lower or higher TTR. For these patients, their CYP2C9 interacting drugs must be used with caution, or at times, their use must cease.
Warfarin’s efficacy and safety profile are
also affected by genetic mutations that lead to a lower activity of the CYP2C9 enzyme, the primary enzyme used to eliminate warfarin from
the body. Clinical studies have shown that these persons require lower dosages of warfarin and are at an increased risk of anticoagulation.
Currently, warfarin is commonly used in patients
with non-valvular AFib and in patients with valvular heart diseases (VHD) with AFib. However, as reported by an article published
by the Egyptian Heart Journal on March 28, 2022, an analysis of 6,454 patients with AFib taking warfarin showed that almost 50% of
the time the INR was outside the target range of 2–3, leading to a higher risk of bleeding and thrombotic complications. The major
adverse effect associated with warfarin is bleeding. Major and fatal bleeding events occur at rates of 7.2 and 1.3 per 100 patient-years,
respectively, according to a meta-analysis of 33 studies.
INR should be more frequently monitored in patients
with impaired kidney function. Patients with impaired kidney function have a decreased ability to metabolize drugs through the CYP450
pathway, and accordingly have an increased risk of being outside their individual INR target range and experiencing lower TTR. Further,
according to an article published by Frontiers in Medicine in January 2021, warfarin was associated with an increase in the risk
of major bleeding without reduction in stroke/thromboembolism or mortality in patients with end-stage CKD requiring dialysis.
As a result of some or all of the above, and other
factors, trials have shown that patients treated with warfarin often experience TTRs lower than 70%, the generally accepted TTR threshold
representing stable anticoagulation. In a 2019 study conducted to evaluate the TTR of 300 patients on long-term warfarin for non-valvular AFib,
as reported by an article published in Health and Quality of Life Outcomes on October 20, 2020, 75.5% of patients had a poor TTR
with a mean of only 39.5%, with the mean TTR of all patients in the study being 47%. In another study of 406 AFib patients conducted in
Lithuania to evaluate the quality of warfarin as anticoagulation therapy, more than half (57.3%) of INR values were outside of the target
range and the median TTR was only 40%, with only 20% of patients having a TTR greater than or equal to 65%.
Non-Vitamin K Oral Anticoagulants (NOACs)
or Direct Acting Oral Anticoagulants (DOACs)
Non-vitamin K oral anticoagulants, or NOACs,
or DOACs, are a form of OAC treatment that inhibits certain blood clotting factors. While VKAs block the synthesis of vitamin K-dependent blood
clotting factors, NOACs block the activity of these clotting factors. There are two classes of NOACs, oral direct thrombin inhibitors
and oral direct factor Xa inhibitors. Currently, there are only four NOACs approved by the FDA for use outside of a hospital setting:
apixaban (the generic name for Eliquis), dabigatran (the generic name for Pradaxa), rivaroxaban (the generic name for Xarelto) and edoxaban
(the generic name for Savaysa). NOACs are generally more rapid in onset and offset of action than VKAs, have few strong drug-to-drug interactions
and do not require INR monitoring.
Limitations of NOAC Treatment for Patients
with ESRD and AFib
NOACs have been approved in the U.S. for
the treatment of specific oral anticoagulation indications; however, there are anticoagulation indications for which NOACs are warned
against use or are not recommended for use, including for anticoagulation treatment in patients with mechanical heart valves. NOACs do
not have the same broad label indication as warfarin and are only indicated for some thrombosis indications.
Our Proposed Solution: Tecarfarin for Treatment
of ESRD and AFib
Tecarfarin, our lead investigational product candidate,
is a VKA, once-daily OAC designed for use in patients with ESRD and AFib. Tecarfarin was designed using a retrometabolic drug design
which targets a different metabolic pathway than the most commonly prescribed drugs for the treatment of thrombosis and AFib. Like warfarin,
tecarfarin will also require INR monitoring. Due to its retrometabolic design, tecarfarin is eliminated by large capacity and non-saturable tissue
esterase pathways that exist throughout the body, rather than just in the liver. This is a metabolic pathway that is distinct from the
CYP450 pathway and infrequently used by other medications, which could potentially reduce the risk for drug-to-drug interactions.
Moreover, unlike warfarin, we do not believe tecarfarin’s metabolism is affected by CYP2C9 genetic variant alleles or by kidney
function.
Given the metabolic process and related safety
issues with warfarin and the limited treatment indications for which NOACs are approved, we believe there is a significant thrombosis
patient population in need of an alternative anticoagulation treatment. The lack of stable and predictable anticoagulation control is
particularly problematic in large underserved patient subpopulations with risk factors such as:
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Patients treated with CYP2C9 interacting drugs; |
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Patients with severely impaired kidney function; |
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Patients with genetic variant alleles for CYP2C9; and |
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Patients with mechanical heart valve implants. |
Tecarfarin Clinical Program
Tecarfarin has been evaluated in eleven clinical
trials: eight Phase 1 trials, two Phase 2 trials and one Phase 2/3 trial evaluating the efficacy and safety of tecarfarin.
We are currently planning to commence what we believe to be our remaining pivotal Phase 3 trial in the first half of 2024. A readout
of the two-year animal carcinogenicity study is expected to be completed in first half of 2024. We will also conduct any further
trials as may be required by the FDA.
A summary of the clinical trials conducted to
date with tecarfarin is shown below.
Study Number |
|
Study Description |
|
Study
Population |
|
Number
Exposed |
|
Date started |
|
Date completed |
|
Sponsor |
ZK-TEK-201905 |
|
Multiple-dose tolerance and PK-PD study of tecarfarin |
|
Healthy Chinese Volunteers |
|
|
40 |
|
|
2020 |
|
January 2021 |
|
Zhaoke Pharmaceutical (Guangzhou) Co., Ltd |
LP-HK-001 |
|
Phase 1, Sequential Cohort, Single-dose escalation study |
|
Healthy Chinese Volunteers |
|
|
40 |
|
|
June 2018 |
|
July 2019 |
|
Lee’s Pharmaceutical (Hong Kong) Limited |
CLN-512 |
|
Phase 1 pharmacokinetic study in chronic kidney disease subjects |
|
Chronic kidney disease subjects; healthy volunteers |
|
|
23 |
|
|
November 2015 |
|
May 2016 |
|
Armetheon, Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CLN-505 |
|
Phase 2/3 randomized, blinded head-to-head anticoagulation in broad indications (EMBRACE-AC) |
|
Patients (all indications) |
|
|
609 |
|
|
June 2008 |
|
December 2009 |
|
ARYx
Therapeutics, Inc. |
CLN-509 |
|
Pilot Phase 2 study for trial methodology to be used in CLN-505 |
|
Patients (all indications) |
|
|
50 |
|
|
January 2008 |
|
August 2008 |
|
ARYx
Therapeutics, Inc. |
CLN-504 |
|
Phase 2a open-label anticoagulation in AFib |
|
Patients Requiring Oral Anticoagulation |
|
|
66 |
|
|
December 2006 |
|
October 2007 |
|
ARYx
Therapeutics, Inc. |
CLN-508 |
|
Phase 1 DDI study with amiodarone |
|
Healthy volunteers |
|
|
19 |
|
|
July 2007 |
|
September 2007 |
|
ARYx
Therapeutics, Inc. |
CLN-507 |
|
Phase 1 DDI study with fluconazole |
|
Healthy volunteers |
|
|
20 |
|
|
June 2007 |
|
August 2007 |
|
ARYx
Therapeutics, Inc. |
CLN-503 |
|
Phase 1 Dose titration to target |
|
Healthy volunteers |
|
|
28 |
|
|
October 2006 |
|
January 2007 |
|
ARYx
Therapeutics, Inc. |
CLN-502 |
|
Phase 1 Effect on INR in multiple dose response |
|
Healthy volunteers |
|
|
42 |
|
|
November 2005 |
|
July 2006 |
|
ARYx
Therapeutics, Inc. |
CLN-501 & CLN-501.X |
|
Phase 1 Safety and human pharmacokinetics |
|
Healthy volunteers |
|
|
66 |
|
|
August 2005 |
|
April 2006 |
|
ARYx
Therapeutics, Inc. |
Phase 2 Trials
CLN-504: Trial CLN-504 was an open-label study
in which 66 patients with AFib were treated with tecarfarin for a period of six weeks, with the option of continuing treatment for
an additional six weeks. The trial, which was conducted by our predecessor company that owned the rights to tecarfarin, was primarily
designed to determine an optimal dosing regimen and monitoring schedule and to describe the efficacy and explore the quality of anticoagulation
as measured by TTR for INR. Before the trial, warfarin-treated patients had a mean TTR of 59.4%. After the initial three weeks
of dose titration, the tecarfarin-treated patients were within the target INR range 71.4% of the time (p<0.001). The most commonly
reported treatment-related adverse events, or TEAEs, were mild hemorrhagic complications of anticoagulation, such as bruising and
nosebleed.
There were two deaths after trial drug treatment
was completed: one patient died due to idiopathic pulmonary fibrosis and pneumonia two weeks following his last dose of tecarfarin,
and one patient died due to bronchial carcinoma two weeks following his last dose of tecarfarin. These deaths were not attributed
to tecarfarin.
CLN-509: The CLN-509 trial was a pilot
Phase 2 study to assess clinical trial methodology to be used in CLN-505, in patients having a variety of clinical indications requiring
chronic oral anticoagulation, as measured by INR. Fifty patients, including patients with AFib, some of whom were already taking warfarin
and some of whom had not, received daily doses of tecarfarin ranging from 1 mg to 60 mg to maintain their INR value (the INR varied based
upon the patient’s condition). The objectives of evaluating safety and INR control in patients with a variety of clinical indications
for chronic oral anticoagulation and assessing the feasibility of tecarfarin treatment in multiple dose strengths were met. INR control
was shown for patients with atrial fibrillation, venous thromboembolic disease, prosthetic heart valves, and cardiomyopathy. There were
no off-target adverse events due to tecarfarin and there were no clinically important safety signals in other measures of safety.
The results of this trial resulted in the development of the clinical trial methodology for the Phase 2/3 trial (EMBRACE-AC).
CLN-505 (EMBRACE-AC): The Phase 2/3
CLN-505 trial, referred to as the EMBRACE-AC trial, was a multi-center, randomized, stratified, double-blind, parallel group,
active control trial for a minimum period of six months and up to one year designed to compare the quality of anticoagulation of
tecarfarin and warfarin as determined by TTR. Dosing of study drugs was managed by a centralized dose control center. In total, 609
patients were enrolled and of those, 607 patients completed the trial and of these, 304 patients received warfarin and 303 patients received
tecarfarin. The EMBRACE-AC trial did not achieve statistical significance on its primary endpoint and the results of the primary
analysis showed that tecarfarin was not superior to warfarin as measured by TTR. However, the TTR observed in patients taking tecarfarin
(72.3%) was numerically similar to patients taking warfarin (71.5%) (difference of 0.8%; p=0.51).
As part of its original design, the EMBRACE-AC trial
included analyses of INR measurements while patients were temporarily off their trial drug due to other medical reasons. Subsequently
a post-hoc analysis was conducted in which we excluded INR values collected during these periods and showed that the percentage of
TTR was higher on tecarfarin (68.8%) than on warfarin (66.4%) (difference of 2.3%; p<0.04).
Post-hoc analyses were conducted in other
patient subgroups in our EMBRACE-AC trial. The following chart depicts the findings of the analysis of the study and the degree to
which TTR% on tecarfarin was higher than on warfarin:
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In the 179 patients taking CYP2C9 interacting drugs, the TTR of patients taking tecarfarin was similar to that of patients taking warfarin (72.2% and 69.9%, respectively; p=0.15). |
|
● |
In the 55 patients taking CYP2C9 interacting drugs who also had a CYP2C9 genetic variant allele, the TTR of patients taking tecarfarin was similar to that of patients taking warfarin (76.5% and 69.5%, respectively; p=0.09). |
|
● |
In the 84 patients with mechanical heart valve implants, the TTR of patients taking tecarfarin was similar to that of patients taking warfarin (68.4% and 66.3%, respectively; p=0.51). |
The potential benefit of tecarfarin over warfarin
as measured by TTR was not demonstrated in EMBRACE-AC. However, the TTR observed in patients taking tecarfarin in the trial, and
in the subpopulations described above, were numerically similar to the TTR observed in the patients taking warfarin, and the TTR observed
in patients taking tecarfarin demonstrated stable anticoagulation. The TTR in patients treated with warfarin exceeded previously reported
TTR rates observed in patients taking warfarin, which are typically in the 50% to 65% range, which we believe was due to the use of dose
control centers in the administration of the trial. When dose control centers are used in the administration of warfarin, large teams
of medical professionals are able to closely monitor patients and mitigate many of the drug-to-drug and genetic variant-related limitations
of the drug that are not easily managed in real world settings.
EMBRACE-AC also provided information for
dosing and dose adjustments for tecarfarin. The average daily doses required of both tecarfarin and warfarin was analyzed in patients
who had poor, intermediate or extensive metabolism capacity of the CYP2C9 enzyme. Patients with poor metabolism capacity of the CYP2C9
enzyme who were treated with warfarin required a significantly lower average daily dose compared to those patients with extensive CY2C9
enzyme metabolism capacity. In contrast, as depicted below, the required dosage of tecarfarin did not vary significantly based on the
patient’s CYP2C9 activity level.
Tecarfarin appeared to be well tolerated with
only 1.6% of the blinded tecarfarin subjects suffering from major bleeding and no thrombotic events. When thrombotic and major bleeding
events during the blinded period were combined, a numerical imbalance favoring tecarfarin over warfarin was seen (warfarin 11 subjects,
3.6%; tecarfarin 5 subjects, 1.6%). The safety data from EMBRACE-AC showed comparable rates of adverse events between the two treatment
groups. TEAEs were reported for 93.2% of patients who received tecarfarin and 90.5% of patients who received warfarin. TEAEs reported
by ≥10% of patients in either treatment group were nasopharyngitis (18.6% and 19.3%, blinded tecarfarin and warfarin, respectively),
contusion (15.6% and 14.8%, respectively), epistaxis (8.1% and 11.1%, respectively), upper respiratory tract infection (10.7% and 10.8%,
respectively), diarrhea (10.1% and 9.2%, respectively) and headache (10.7% and 8.9%, respectively). Most TEAEs were mild (32.2%, tecarfarin
and 30.2%, warfarin) or moderate (45.0% and 46.6%, respectively) in severity.
The trial had some limitations. The TTR with warfarin
achieved in Embrace-AC was much higher than that typically seen in clinical trials and as compared to “real-world practice,”
exceeding 71% on an interpolated basis in both treatment arms. The most likely reason stemmed from the dosing of study drugs which was
managed by a centralized dose control center, which had access to genotyping.
Five patients died during the trial, with four
deaths occurring during the double-blind period: one patient (tecarfarin; off drug) died due to mantle cell lymphoma, pneumonia and
sepsis; one patient (tecarfarin; on drug) died due to cardiorespiratory arrest and myocardial infarction; one patient (warfarin; off drug)
died due to metastatic colon cancer; one patient (warfarin; off drug) died due to lung cancer; and one patient (not randomized) died due
to intracerebral hemorrhage. The patient who died due to intracerebral hemorrhage was considered to be possibly related to the study drug,
but the remaining four deaths were not attributed to the drug.
During the blinded period of the trial, five patients
on tecarfarin and six patients on warfarin experienced major bleeding events. The occurrence of major bleeding events for both tecarfarin
and warfarin was lower when compared to prior anticoagulation trials. Among warfarin-treated patients, there were five thrombotic
events (two ischemic strokes, two deep vein thromboses and one pulmonary embolism), while there were no such events among tecarfarin-treated patients.
Phase 1 Trials
CLN-501: Trials CLN-501 and CLN-501.X
evaluated the safety tolerability of tecarfarin in a total of 64 healthy volunteers. The studies were sufficiently similar in their requirements
and study populations to be combined and analyzed together. The primary differences between the studies were the study drug formulation
(CLN-501 used a solution formulation while study 501.X used tablets) and the range of single doses studied. In CLN-501, cohorts of
6 eligible subjects were randomly assigned to receive tecarfarin at one of eight ascending dose levels between 0.2 and 10.0 mg or placebo.
In CLN-501.X, similar cohorts received tecarfarin at one of three ascending dose levels (20.0, 30.0, or 40.0 mg) or placebo. The studies
demonstrated that there were no apparent differences between pharmacokinetics parameters after tecarfarin was administered at single doses
from 0.2 to 10.0 mg as an oral solution or at single doses from 20.0 to 40.0 mg as an oral solid tablet formulation and that tecarfarin
was well-tolerated.
CLN-502: Trial CLN-502 evaluated tecarfarin
pharmacokinetics, dose range, and duration of dosing that would attain a stead steady state INR of 1.7 to 2.0 and would give stead-state plasma
concentrations of tecarfarin. Forty-two healthy volunteer subjects were randomized and received either 1, 3, 6, 10, 20, 30,
or 40 mg of tecarfarin or placebo (the 3 and 6 mg cohorts were discontinued after one week due to lack of pharmacodynamic effect). The
study successfully determined the active dose of tecarfarin and provided the pharmacokinetic and pharmacodynamic basis for subsequent
multidose trials. Doses of 20 mg and above brought subjects into the target INR range of 1.7 to 2.0, with the 40 mg dose bringing all
subjects into the target range within one week of dosing. The trial demonstrated that tecarfarin was well-tolerated at all doses
studied as assessed by adverse events, vital signs, electrocardiography, and laboratory testing, and that a loading dose of 40 mg could
be appropriate for initiating anticoagulation in Phase II trials.
CLN-503: Trial CLN-503 evaluated the
safety and tolerability of tecarfarin versus warfarin when administered alone and in combination with amiodarone as measured by INR in
28 healthy subjects. During the first phase, subjects were administered tecarfarin or warfarin for 10 days, with doses titrated daily
to achieve a target INR range of 1.5 to 2.0. Subjects who remained within the target INR range without requiring a dose change continued
to the next phase with amiodarone, with all subjects receiving 200 mg amiodarone twice daily in addition to tecarfarin or warfarin. The
primary objectives of the trial were completely met. Both tecarfarin and warfarin were well-tolerated, both alone and in the presence
of amiodarone. There were no safety signals as ascertained by adverse event reports, clinical laboratory testing, vital sign measurement,
and by electrocardiography. The quality of anticoagulation was good for both cohorts and a target INR was reached and maintained during
the 3-day maintenance period. The results of the trial suggested the use of the same INR therapeutic range for tecarfarin as is recommended
for warfarin.
CLN-507: Trial CLN-507 evaluated the
effects of co-administration of fluconazole, a drug that blocks the activity of the CYP450 enzyme, with either 50 mg tecarfarin
or 17.5 mg warfarin in 20 healthy volunteers. The trial demonstrated that co-administration of fluconazole did not affect the
metabolism or elimination of tecarfarin. In contrast, the co-administration of fluconazole prolonged the half-life of warfarin.
CLN-512: Trial CLN-512 evaluated the
effects of severe chronic kidney dysfunction on the metabolism and elimination of tecarfarin and warfarin. Thirteen patients with severe
kidney dysfunction (stage 4 chronic kidney disease, or CKD) and 10 healthy volunteers (matched for age, weight, gender and CYP2C9 genotype)
were administered 30 mg tecarfarin and 10 mg warfarin in a randomized crossover design. The trial demonstrated that tecarfarin’s
elimination from the body was not affected by severe kidney dysfunction: the half-life and the amount of drug in the body were similar
in people with CKD and healthy patients. In contrast, the plasma concentration and half-life of warfarin was increased in patients
with CKD, with warfarin’s exposure increasing 44% in these patients. These effects were exaggerated in patients with CYP2C9 genetic
variant alleles and in those who required concomitant CYP2C9 interacting drugs. At the conclusion of the trial, the safety of repeated
dosing of tecarfarin in CKD patients remained unknown. However, overall, the results of this study suggest that no adjustment in the dose
of tecarfarin is needed for patients with CKD.
CLN-508: Trial CLN-508 evaluated the
effects of co-administration of 400 mg amiodarone with either 50 mg tecarfarin or 17.5 mg warfarin in 19 healthy volunteers,
nine on tecarfarin and 10 on warfarin. Amiodarone, a drug used to treat irregular heartbeat, is a moderately potent inhibitor of CYP2C9
metabolism and is frequently used as a treatment for AFib in combination with warfarin. The effects of amiodarone on the pharmacokinetics
of warfarin and tecarfarin showed that the exposure was increased to about the same extent for both drugs. The exposure of R-warfarin increased
by 27% and the exposure for S-warfarin increased by 38%. The exposure of tecarfarin increased by approximately 31%. These changes
in exposure did not result in any changes in INR in either the tecarfarin or the warfarin cohorts and demonstrated that tecarfarin behaved
similarly to warfarin when administered in combination with amiodarone.
An Open-label, Phase 1, Sequential
Cohort, Single-Dose Escalation Study to Assess the Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers
Study Protocol: LP-HK-001 completed in July 2019
This was an open-label, phase 1, sequential
cohort, single-dose escalation study conducted in China to assess the safety and tolerability of tecarfarin (ATI-5923) in healthy
Chinese volunteers. The study site enrolled up to a total of 40 subjects. Ten (10) healthy Chinese subjects received tecarfarin (ATI-5923)
at each dose level (i.e., 10 mg, 20 mg, 30 mg and 40 mg).
The safety assessment results of this study were
consistent with the results of CLN-501 study, and there was no safety risk after single dose administration of 10mg~40mg tecarfarin.
AEs with higher incidence rate included headache and dizziness, and such AEs were graded as mild in severity. Tecarfarin showed a promising
safety and tolerability profile in Chinese subjects.
Based on the results in this open-labelled, single-dose escalation,
phase 1 study of tecarfarin, the following conclusions were made:
Single dose administration of tecarfarin in dose
level ranging from 10 mg to 40 mg had no clinically significant effect on coagulation function. However, a slightly increasing
trend in INR and PT values were observed with dose escalation. A slightly decreasing trend in coagulation factors II, VII and X
were observed with dose escalation. Tecarfarin showed a promising safety and tolerability profile in Chinese subjects. The results of
this study warrant further multiple-dose pharmacokinetic studies in the Chinese population. We do not believe we can extrapolate
this data to other populations, including the United States, but other trials were performed in the U.S.
A Multiple-Dose, Safety and Tolerability
PK/PD Study of Tecarfarin in Healthy Chinese Volunteers
Study Protocol: ZK-TEK-201905 completed
in January 2021
This was a multiple-dose phase 1 pharmacokinetic-pharmacodynamic study
conducted in China to assess the safety and tolerability of tecarfarin in healthy Chinese volunteers. The study site enrolled up to a
total of 40 subjects. Ten (10) healthy Chinese subjects received tecarfarin once-daily on fasting every morning for 14 days
at each dose level (i.e., 10 mg, 20 mg, 30 mg and 40 mg).
Tecarfarin was well tolerated in Chinese volunteers
without serious adverse events in both single ascending dose and multiple ascending dose (“MAD”) studies. There was only one
treatment related adverse event (hematochezia) that resulted in early withdrawal in the MAD 40mg cohort. Exposure levels of tecarfarin
were generally dose proportional.
Summary of Tecarfarin Clinical Trials
Clinical and preclinical trials of tecarfarin
have demonstrated lack of drug-to-drug interactions with tecarfarin, predictable clearance that is independent of CYP450 blood clotting
factors and any genetic variation in these factors, and the lack of impact of kidney function on clearance of tecarfarin. In the largest
and longest of the clinical trials, EMBRACE-AC, tecarfarin and warfarin were found to have similar major and overall bleeding risks. In
EMBRACE-AC, warfarin-treated patients had five thrombotic events, while there were no such events among tecarfarin-treated patients.
When thrombotic and major bleeding events were combined, a trend favoring tecarfarin over warfarin was seen (five tecarfarin patients
(1.6%) compared to 11 warfarin patients (3.6%)). We will conduct further studies and intend to submit this data to FDA in the NDA.
Upcoming Pivotal Phase 3 Trial: CLN-515
(ACTOR AF)
In the second half of 2023, we intend to commence
our Phase 3, randomized, double-blind, placebo-controlled study of tecarfarin in subjects with ESRD and AFib not currently treated
with chronic oral anticoagulation. The study will assess the safety and efficacy of evaluate the efficacy and safety of tecarfarin (target
INR 2.0-3.0) in subjects with ESRD (stage 5 — eGFR < 15 mL/min/1.73 mm2) and AFib. Subjects must have chronic paroxysmal,
persistent or permanent AFib documented. All subjects will undergo genetic testing for VKORC1 prior to randomization, which will also
be used for stratification at the time of randomization. Subjects will be randomly assigned to receive either blinded tecarfarin or placebo
in a 1:1 ratio. Approximately 540 subjects (270 per arm) will be enrolled in the study.
An enrollment period of 15 months is anticipated.
A 10% dropout rate (48 subjects) is anticipated resulting in 492 evaluable subjects. All subjects enrolled in the study will remain on
study drug until the last subject enrolled completes a minimum of 12 months of therapy or until the required number of adjudicated
major adverse cardiovascular events (death, ischemic stroke, pulmonary embolus, and/or myocardial infarction) have been obtained, whichever
is later. The primary efficacy assessment is time to first major adverse cardiovascular event, or MACE. There will be approximately
125 study sites in the United States and Canada, with other trial sites to be determined. Based upon internal statistical projections,
assuming the Phase 3 clinical trial is powered at 80%, the study is expected to demonstrate a treatment effect of 25%.
Sub-License
Lee’s Pharmaceutical Holdings Limited
License
In September 2015, China Cardiovascular Focus
Ltd., a wholly owned subsidiary of Lee’s Pharmaceutical Holdings Limited, or LPH, entered into an agreement (the “LPH License”)
with Armetheon for the license, development and commercialization of our tecarfarin compound in China, Hong Kong, Macau, Taiwan and
Thailand (the “Territory”). In October 2017, Armetheon merged with Espero BioPharma, Inc., or Espero. The assets owned
by Espero were assigned to HESP LLC in a court-approved assignment for the benefit of creditors. On April 1, 2022 we acquired
from HESP LLC, pursuant to an asset purchase agreement, the assets related to tecarfarin, including the LPH License. Under the terms of
the LPH License, LPH provided a non-refundable up-front payment of $1 million and agreed, during the term of the agreement,
not to develop, manufacture or commercialize a competitive product in the Territory. Conversely, we agreed not to develop, manufacture
or commercialize a competitive product in the Territory. If all potential development, regulatory and commercial milestones under the
LPH License are met, we are entitled to receive payments of approximately $52.0 million. In addition, we are also entitled to receive
royalties between 9% to 15% of the net sales of tecarfarin in certain specified markets. The LPH License expires on a country-by-country basis
within the Territory, upon the latest of the expiration of the last intellectual property covering the tecarfarin compound in such country
of the Territory, or the twelfth anniversary of the first commercial sale of tecarfarin in such country of the Territory.
Manufacturing
We do not have a manufacturing infrastructure
and do not intend to develop one. We intend to contract with third parties for the production and packaging of our products and product
candidates. With respect to tecarfarin, we are negotiating a contract with a third-party contract pharmaceutical manufacturer to
perform the work necessary to develop a validated manufacturing process and to scale up for commercial production. However, we have not
entered into any long-term supply agreements or commercialization partnership with these vendors. We anticipate that certain of the
manufacturing sites for our products and product candidates may be in locations outside of the U.S.
While the drug substances used in our product
candidate are manufactured by more than one supplier, the number of manufacturers is limited. In the event it is necessary or advisable
to acquire supplies from an alternative supplier, we might not be able to obtain them on commercially reasonable terms, if at all. It
could also require significant time and expense to redesign our manufacturing processes to work with another company. If approved by the
FDA, we anticipate that we will be able to enter into agreements with suppliers to formulate and distribute tecarfarin on commercially
reasonable terms.
Sales and Marketing
If any of our product candidates are approved
by the FDA or other regulatory authorities, we intend to commercialize our products by leveraging our existing commercial infrastructure
and hiring and training a small and dedicated cardiorenal salesforce to commercialize our products in the U.S., and possibly other major
markets. In addition, we anticipate entering into a variety of distribution agreements and commercial partnerships in those territories
where we do not establish an internal sales force, including if we expand outside of the U.S. We expect that our specialized commercial
cardiovascular team would be comprised of experienced marketing and sales management professionals.
Market Opportunity
Based upon data of untreated patients with ESRD
and AFib (40,823) and orphan drug pricing of $65 per day (or $23,400 annually) derived from a 2019 study commissioned by us (adjusted
for inflationary increases in the per day pricing), and assuming that we receive FDA approval of tecarfarin, we estimate that the
annual U.S. market revenue potential for tecarfarin is approximately $1 billion.
Competition
There have been several randomized trials to definitively
assess the treatment effects of apixaban compared with VKAs in the population dependent on dialysis. The RENAL-AF (Trial to Evaluate
Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation) was terminated early in 2019 by its sponsor. In addition, the
AXADIA study (Compare Apixaban and Vitamin-K Antagonists in Patients With Atrial Fibrillation and End-Stage Kidney Disease),
which is currently recruiting patients, will randomize patients to apixaban 2.5 mg twice daily versus phenprocoumon. The randomization
of study drug and blinded event adjudication in these trials will help to minimize bias and confounding, and will better elucidate the
risks and benefits of standard versus low-dose apixaban. Neither of these trials are adequately powered to address the important
questions relating to intracerebral hemorrhage.
The development and commercialization of new drugs
is highly competitive. We face competition with respect to developing our current product candidate, and we will face competition with
respect to any products that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical
companies and biotechnology companies worldwide. We are seeking to develop tecarfarin as a marketable VKA, once-daily OAC for chronic
anticoagulation, and we are seeking to develop as a marketable oral drug for the treatment and prevention of refractory AFib. If we succeed
in developing the lead indication or additional indications, we will face substantial competition. Existing anticoagulant treatments for
thrombosis include warfarin and NOACs such as Pradaxa (dabigatran), Xarelto (rivaroxaban), Eliquis (apixaban) and Savaysa (edoxaban) for
specific indications. The entry of the first generic NOACs, starting with Boehringer Ingelheim’s loss of U.S., Japanese and Canadian
patent protection for Pradaxa (dabigatran) in November 2018 and the remaining NOACs by 2024, could increase competition and reduce
the total dollars spent on the treatment of thrombosis, as a result of lower generic drug pricing. The next generation of anticoagulants
in development, Factor XI inhibitors, are currently in Phase 2 studies.
Many of these named products are marketed by some
of the largest and most successful pharmaceutical companies worldwide. The companies that market these products have substantially more
resources than we do and substantially more experience developing and marketing pharmaceuticals. We may not be able to successfully compete
with these existing products. Potential competitors also include academic institutions, government agencies and other public and private
research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development,
manufacturing and commercialization of competing drugs and potentially competing drugs. Our competitors are developing or may be attempting
to develop therapeutics for our target indications.
Factors affecting competition in these markets
include the financial, research and development, testing, and marketing strengths of individual competitors, trends in industry consolidation,
consumers’ product options, product quality, price, technology, reputation, customer service capabilities and access to market partners
and customers. Eliquis is manufactured and distributed by Bristol Myers Squibb, amiodarone is manufactured and distributed by several
companies, including Sanofi, Baxter, and Pfizer, Pradaxa is manufactured and distributed by Boehringer Ingelheim, Xarelto is manufactured
and distributed by Janssen Pharmaceuticals, and Savaysa is manufactured and distributed by Daiichi Sankyo. Each of these organizations
has a long operating history, extensive resources, strong brand recognition and large customer base. As a result, we expect they will
be able to devote greater resources than we can to the manufacture, promotion and sale of their products, receive greater resources and
support than we will from market partners and independent distributors, initiate and withstand substantial price competition, and take
advantage more readily than we could of acquisition and other strategic market opportunities. In addition, these or other organizations
could succeed in developing new products that perform better or more cost-effectively than our products and product candidates in
their respective markets. Moreover, changes in health trends, diet or other factors could substantially reduce the commercial attractiveness
or viability of anti-anginal, anticoagulant, anti-arrhythmic and anti-platelet products.
The high level of competition in these markets
could result in pricing pressure, reduced margins, the inability of our product candidates to achieve market acceptance and other impediments
to commercial success. As a result, there can be no assurance that we will be able to complete the development of competitive products
and commercialize them on a competitive basis.
Mergers and acquisitions in the pharmaceutical,
biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with
large and established companies. These companies compete with us in recruiting and retaining qualified scientific and management personnel,
establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to,
or necessary for, our programs.
Intellectual Property
Our success will significantly depend upon our
ability to obtain and maintain patent and other intellectual property and proprietary protection for our drug candidates, including market
and data exclusivity granted by regulatory agencies and composition-of-matter, dosage and formulation patents, as well as patent and other
intellectual property and proprietary protection for our novel biological discoveries and other important technology inventions and know-how.
In addition to patents, we rely upon unpatented trade secrets, know-how, and continuing technological innovation to develop and maintain
our competitive position. We protect our proprietary information, in part, using confidentiality agreements with our commercial partners,
collaborators, employees and consultants and invention assignment agreements with our employees. We also have confidentiality agreements
or invention assignment agreements with our commercial partners and selected consultants. Despite these measures, any of our intellectual
property and proprietary rights could be challenged, invalidated, circumvented, infringed or misappropriated, or such intellectual property
and proprietary rights may not be sufficient to permit us to take advantage of current market trends or otherwise to provide competitive
advantages. For more information, please see “Risk Factors — Risks Related to Our Intellectual Property.”
We have two issued U.S. patents directed
to tecarfarin. The expiration dates of the patents are 2024 for both our composition of matter patent and our method of treatment patent,
not including any possible patent term extension. Foreign patents corresponding to the tecarfarin patents expire in 2025. If our patents
expire, we may not be able to adequately protect our intellectual property, and competitors may be able to erode or negate any competitive
advantage we may have, which could harm our business and ability to achieve profitability.
However, in the U.S., the term of a patent covering
an FDA-approved drug may be eligible for a patent term extension under the Hatch-Waxman Act as compensation for the loss of
patent term during the FDA regulatory review process. The period of extension may be up to five years beyond the expiration of the
patent, but cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. Only one patent
among those eligible for an extension may be extended. For patents that might expire during the application phase, the patent owner may
request an interim patent extension. An interim patent extension increases the patent term by one year and may be renewed up to four times.
For each interim patent extension granted, the post-approval patent extension is reduced by one year. The director of the United States
Patent and Trademark Office must determine that approval of the drug covered by the patent for which a patent extension is being sought
is likely. Interim patent extensions are not available for a drug for which an NDA has not been submitted. Provisions are available in
certain other jurisdictions to extend the term of a patent that covers an approved drug or to provide data exclusivity. For example, data
exclusivity in the EU may be available for 10 years from approval and in Japan for eight years from approval. It is possible
that issued U.S. patents covering tecarfarin may be entitled to patent term extensions. If our product candidates receive FDA approval,
we intend to apply for patent term extensions, if available, to extend the term of patents that cover the approved product candidates.
We also intend to seek patent term extensions in any jurisdictions where they are available, however, there is no guarantee that the applicable
authorities, including the FDA, will agree with our assessment of whether such extensions should be granted, and even if granted, the
length of such extensions.
The following is a list of our U.S. and foreign
patents:
Tecarfarin Patents |
Country |
|
Patent No.
(Application No.) |
|
Grant Date |
|
Type of Patent
Protection |
|
Expiration Date |
U.S.A. |
|
|
7666902 |
|
02/23/2010 |
|
Method of treatment |
|
April 8, 2024 |
U.S.A. |
|
|
7253208 |
|
08/07/2007 |
|
Composition of matter |
|
April 8, 2024 |
U.S.A. |
|
|
7285671 |
|
10/23/2007 |
|
Composition of matter
(chloro derivative)(1) |
|
April 8, 2024 |
Australia |
|
|
2005233614 |
|
7/12/2012 |
|
Composition of matter |
|
April 8, 2025 |
Austria |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Belgium |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Belgium |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Brazil |
|
|
PI0508392-3 |
|
|
|
Composition of matter |
|
April 8, 2025 |
Canada |
|
|
2559568 |
|
5/28/2013 |
|
Composition of matter |
|
April 8, 2025 |
China |
|
|
1950353-B
(200580012074.6) |
|
6/1/2011 |
|
Composition of matter |
|
April 8, 2025 |
Cyprus |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Denmark |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Denmark |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Europe |
|
|
1735296
(05733799.0) |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Europe |
|
|
2161261
(09175606.4) |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Finland |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Finland |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
France |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
France |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Germany |
|
|
602005018181.4 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Germany |
|
|
602005041073.2 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Great Britain |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Great Britain |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Greece |
|
|
3071104 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Hong Kong |
|
|
1105200 |
|
3/9/2012 |
|
Composition of matter |
|
April 8, 2025 |
Hong Kong |
|
|
1138265 |
|
5/23/2014 |
|
Use |
|
April 8, 2025 |
India |
|
|
250594
(2793/KOLNP/2006) |
|
1/11/2012 |
|
Composition of matter |
|
April 8, 2025 |
Ireland |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Ireland |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Israel |
|
|
178122 |
|
5/4/2013 |
|
Composition of Matter |
|
April 8, 2025 |
Italy |
|
|
502010901815570 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Italy |
|
|
502013902212109 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Japan |
|
|
5036532 |
|
7/13/2012 |
|
Composition of matter |
|
April 8, 2025 |
Luxembourg |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Luxembourg |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Mexico |
|
|
274321
(PA/a/2006/011637) |
|
3/3/2010 |
|
Composition of matter |
|
April 8, 2025 |
Monaco |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Monaco |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
(1) |
This patent is not directed to tecarfarin, but rather is a derivative of tecarfarin. |
Country |
|
Patent No.
(Application No.) |
|
Grant Date |
|
Type of Patent
Protection |
|
Expiration Date |
Netherlands |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Netherlands |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Norway |
|
|
338837 |
|
10/24/2016 |
|
Composition of matter |
|
April 8, 2025 |
Philippines |
|
|
1-2006-501866 |
|
11/19/2010 |
|
Composition of matter |
|
April 8, 2025 |
Portugal |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Russia |
|
|
2335501-C2 |
|
10/10/2008 |
|
Composition of matter |
|
April 8, 2025 |
Russia |
|
|
2495034-C2 |
|
10/10/2013 |
|
Method of Treatment |
|
April 8, 2025 |
South Africa |
|
|
2006/07667 |
|
11/28/2007 |
|
Composition of matter |
|
April 8, 2025 |
South Korea |
|
|
10-1203124 |
|
11/14/2012 |
|
Composition of matter |
|
April 8, 2025 |
Spain |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Spain |
|
|
09175606.4 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Sweden |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Sweden |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Switzerland |
|
|
1735296 |
|
12/9/2009 |
|
Composition of matter |
|
April 8, 2025 |
Switzerland |
|
|
2161261 |
|
8/28/2013 |
|
Use |
|
April 8, 2025 |
Data Exclusivity
If tecarfarin is approved by the FDA, we expect
to receive five years of data exclusivity, often referred to as new chemical entity exclusivity, for our tecarfarin NDA, so long as FDA
has not approved a drug containing the same active moiety as tecarfarin. It is possible that the FDA may disagree with our position and
not approve tecarfarin or grant new chemical exclusivity to our NDA for tecarfarin. Assuming the FDA approves tecarfarin and new chemical
entity exclusivity is granted, during the five-year period, no generic applicant can file an abbreviated drug application referencing
our NDA for tecarfarin, unless the generic applicant challenges a patent listed in the FDA Orange Book for the referenced NDA, in which
case the generic applicant can file after four years. If the patent is asserted against the generic applicant within 45 days of receipt
of a required notice letter by the generic applicant, the generic abbreviated drug application cannot be approved by FDA for up to thirty
months.
Government Regulation
The process of obtaining regulatory approvals
and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial
time and financial resources. Failure to comply with the applicable requirements at any time during the product development process, approval
process or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s
refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning or untitled letters, product recalls or withdrawals
from the market, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government
contracts, restitution, disgorgement, or civil or criminal penalties.
Product development and marketing activities are
subject to extensive regulation by various government authorities, including the FDA, other federal, state and local agencies and comparable
regulatory authorities in other countries, which regulate the design, research, clinical and non-clinical development, testing, manufacturing,
storage, distribution, import, export, labeling, advertising and marketing of pharmaceutical products and devices. Generally, before a
new drug can be sold, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific
to each regulatory authority, submitted for review and approved by the regulatory authority. The data are often generated in two distinct
development states: pre-clinical and clinical.
Among other matters, U.S. and foreign anti-corruption,
anti-money laundering, export control, sanctions, and other trade laws and regulations, which are collectively referred to as Trade
Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors,
and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper
payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial
criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud
litigation, reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of government
agencies or government-affiliated hospitals, universities, and other organizations. We also expect our non-U.S. activities to
increase in time. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations,
and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents, or partners,
even if we do not explicitly authorize or have prior knowledge of such activities.
Development of Drugs in the United States
Pharmaceutical products must be approved by the
FDA before they may be legally marketed in the United States. Pharmaceutical product development for a new product or certain changes
to an approved product in the U.S. typically involves pre-clinical laboratory and animal tests, the submission to the FDA of
an investigational new drug application, or IND, which must become effective before clinical testing may commence, and adequate and well-controlled clinical
trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought. Satisfaction of FDA
pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the
type, complexity and novelty of the product or disease.
The pre-clinical development stage generally
involves synthesizing the active component, developing the formulation and determining the manufacturing process, as well as carrying
out non-human toxicology, pharmacology and drug metabolism trials that support subsequent clinical testing. These pre-clinical laboratory
and animal tests must comply with federal regulations and requirements, including the FDA’s good laboratory practices regulations.
A drug’s sponsor must submit the result of the pre-clinical tests, together with manufacturing information, analytical data
and any available clinical data or literature and a proposed clinical protocol to the FDA as part of an IND application. A 30-day waiting
period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has neither commented
on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.
Clinical trials involve the administration of
the investigational new drug to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must
be conducted (i) in compliance with federal regulations, including good clinical practices, or GCPs, an international standard meant
to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors; and (ii) under
protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be
evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part
of the IND.
Clinical trials to support NDAs for marketing
approval can generally be divided into three sequential phases that may overlap, Phase 1, Phase 2 and Phase 3 clinical
trials. In Phase 1, generally, small numbers of healthy volunteers are initially exposed to single escalating doses and then multiple
escalating doses of the product candidate. The primary purpose of these trials is to assess the metabolism, pharmacologic action and general
safety of the drug. Phase 2 trials typically involve trials in disease-affected patients to determine the dose required to produce
the desired benefits, common short-term side effects and risks. Phase 2 trials are typically well-controlled, closely monitored,
and conducted in a relatively small number of patients, usually involving no more than several hundred patients. Phase 3 trials are
intended to gather the additional information about effectiveness and safety in a larger number of patients, typically at geographically
dispersed clinical trial sites, that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate
basis for physician labeling. Phase 3 trials usually include from several hundred to several thousand patients and are closely controlled
and monitored. In many cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy
of the drug. A single Phase 3 trial with other confirmatory evidence may be sufficient in some instances. In addition to these Phase 1-3 trials,
other trials may be conducted to gather additional safety, pharmacokinetic and pharmacodynamic information. Pharmaceutical products with
active ingredients that are the same as or similar to those already approved by the FDA may have more streamlined development programs
than new chemical entities.
The FDA may order the temporary, or
permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either
is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. Trials
must be conducted in accordance with GCPs and reporting of study progress and any adverse experiences is required. The study
protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board,
or IRB, responsible for overseeing trials at particular sites and protecting human research trial patients. An independent
institutional review board may also suspend or terminate a trial once initiated, for failure to comply with the IRB’s
requirements, or may impose other conditions. Accordingly, we cannot be sure that submission of an IND, will result in the FDA
allowing clinical trials to begin, or that once begun, issues will not arise that could cause the trial to be suspended or
terminated.
Post-approval trials, sometimes referred
to as Phase 4 clinical trials, may be conducted after initial marketing approval. Sometimes, these trials are used to gain additional
experience from the treatment of patients in the intended therapeutic condition. In certain instances, the FDA may mandate the performance
of Phase 4 trials. In other situations, post-approval trials aim to gain additional indications for a medication.
Changes to some of the conditions established
in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and
FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a new indication typically requires
clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements
as it does in reviewing NDAs.
Review and Approval in the United States
Following Phase 3 trial completion, data
are analyzed to determine safety and efficacy, with any final such determination to be made by the FDA. Data are then submitted to
the FDA in an NDA, along with proposed labeling for the product and information about the manufacturing and testing processes and facilities
that will be used to ensure product quality. The cost of preparing and submitting an NDA is substantial. Manufacturers may be assessed
up to five program fees for a fiscal year for prescription drug products identified in a single approved NDA. These fees are typically
increased annually. In the United States, FDA approval of an NDA must be obtained before marketing a new drug.
The FDA has 60 days from its receipt of an
NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that the application
is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review.
The FDA has agreed to certain performance goals in the review of NDAs. Most applications for standard review drug products are reviewed
within 10 to 12 months; most applications for priority review drugs are reviewed in six to eight months. Priority review can
be applied to drugs that the FDA determines offer major advances in treatment, or provide a treatment where no adequate therapy exists.
The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain
late-submitted information, or information intended to clarify information already provided in the submission.
The FDA may also refer applications for novel
drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee — typically
a panel that includes clinicians and other experts — for review, evaluation, and a recommendation as to whether the application
should be approved. The FDA is not bound by the recommendations of advisory committees, but it generally follows such recommendations.
Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the
FDA will inspect the facility or the facilities at which the drug is manufactured.
The FDA may conduct a pre-approval inspection
of the manufacturing facilities for the new product to determine whether they comply with current good manufacturing practice requirements.
The FDA will not approve the product unless compliance with current good manufacturing practices, or GMPs, is satisfactory and the NDA
contains data that provide substantial evidence that the drug is safe and effective in the indication studied.
After the FDA evaluates the NDA and the manufacturing
facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies
in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application.
If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an
approval letter. The FDA has committed to reviewing such resubmissions in two to six months depending on the type of information
included.
An approval letter authorizes commercial marketing
of the drug with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a risk
evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the drug outweigh the potential risks. REMS can include
medication guides, communication plans for healthcare professionals, and elements to assure safe use, or ETASU. ETASU can include,
but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances,
special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability
of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s
safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems
are identified following initial marketing.
Pediatric Information
Under the Pediatric Research Equity Act, or PREA,
NDAs or supplements to NDAs must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant
pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective.
The FDA may grant full or partial waivers, or deferrals, for submission of data. Unless otherwise required by regulation, PREA does not
apply to any drug for an indication for which orphan designation has been granted.
The Best Pharmaceuticals for Children Act, or
BPCA, provides NDA holders a six-month extension of any exclusivity — patent or non-patent — for
a drug if certain conditions are met. Conditions for exclusivity include the FDA’s determination that information relating to the
use of a new drug in the pediatric population may produce health benefits in that population, the FDA’s written request for pediatric
studies, and the applicant’s agreeing to perform, and reporting on, the requested studies within the statutory timeframe. Applications
under the BPCA are treated as priority applications, with all of the benefits that designation confers.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan
drug designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer
than 200,000 individuals in the United States. Orphan product designation must be requested before submitting an NDA. After
the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the
FDA. Orphan product designation does not convey any advantage in or shorten the duration of regulatory review and approval process.
It also does not suggest FDA approval or exclusivity. The first NDA applicant to receive FDA approval for a particular active ingredient
to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for
that product, for that indication. In addition to the potential period of exclusivity, orphan designation makes a company eligible for
grant funding of up to $500,000 per year for four years to defray costs of clinical trial expenses, tax credits for clinical research
expenses and potential exemption from the FDA application user fee.
Orphan drug exclusivity means the FDA may not
approve any other applications to market the same drug for the same indication for seven years, except in limited circumstances,
such as (i) the drug’s orphan designation is revoked; (ii) its marketing approval is withdrawn; (iii) the orphan
exclusivity holder consents to the approval of another applicant’s product; (iv) the orphan exclusivity holder is unable to
assure the availability of a sufficient quantity of drug; or (v) a showing of clinical superiority to the product with orphan exclusivity
by a competitor product. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition,
or the same drug for a different disease or condition. If a drug designated as an orphan product receives marketing approval for an indication
broader than what is designated, it may not be entitled to orphan drug exclusivity. There has been recent litigation concerning FDA’s
interpretation of the orphan drug exclusivity provisions.
Accelerated Approval
There are a variety of pathways under which applicants
may seek expedited approval from FDA, including Fast Track, breakthrough therapy, priority review and accelerated approval. Fast Track
is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill
an unmet medical need. Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the
FDA to discuss the drug’s development plan, including the design of the proposed clinical trials, use of biomarkers and the extent
of data needed to support approval. Drugs with Fast Track designation may also qualify for accelerated approval and priority review of
new drug applications if relevant criteria are met. However, Fast Track designation may be withdrawn by the FDA if the FDA believes that
the designation is no longer supported by data emerging in the clinical trial process.
The FDA accelerated approval program provides
for early approval of drugs based on a drug on a clinical trial(s) showing that the drug meets a surrogate or an intermediate clinical
endpoint rather than a clinical benefit endpoint. Accelerated approval is possible for drugs for serious conditions that fill an unmet
medical need. Under priority review, the FDA reviews an application in six months rather than ten months after it is accepted for filing.
A surrogate endpoint used for accelerated approval
is a marker, such as a laboratory measurement, that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.
Likewise, an intermediate clinical endpoint is a measure of a therapeutic effect that is considered reasonably likely to predict the clinical
benefit of a drug, such as an effect on irreversible morbidity and mortality. Because it sometimes can take many years for a drug
trial to show a clinical benefit, the use of a surrogate endpoint or an intermediate clinical endpoint can significantly shorten the time
required to complete clinical trials and obtain FDA approval.
If a drug receives an accelerated approval, the
company that sponsored the application must conduct a post-approval trial to confirm the anticipated clinical benefit. These trials
are known as Phase 4 or post-approval confirmatory trials. If the confirmatory trial shows that the drug actually provides a
clinical benefit, then the FDA grants traditional approval for the drug. Failure to conduct required post-approval studies, or confirm
a clinical benefit during post-marketing studies, will allow the FDA to withdraw the drug from the market on an expedited basis.
All promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA. If the
confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing
the drug from the market.
Drug Development in Europe
In the European Union, our future products may
also be subject to extensive regulatory requirements. Similar to the United States, the marketing of medicinal products is subject
to the granting of marketing authorizations by regulatory agencies. Also, as in the United States, the various phases of pre-clinical and
clinical research in the European Union are subject to significant regulatory controls.
Review and Approval in the European Union
In the European Union, approval of new medicinal
products can be obtained through one of three processes: the mutual recognition procedure, the centralized procedure and the decentralized
procedure. We intend to determine which process we will follow, if any, in the future.
Mutual Recognition Procedure: An applicant
submits an application in one European Union member state, known as the reference member state. Once the reference member state has granted
the marketing authorization, the applicant may choose to submit applications in other concerned member states, requesting them to mutually
recognize the marketing authorizations already granted. Under this mutual recognition process, authorities in other concerned member states
have 55 days to raise objections, which must then be resolved by discussion among the concerned member states, the reference member
state and the applicant within 90 days of the commencement of the mutual recognition procedure. If any disagreement remains, all
considerations by authorities in the concerned member states are suspended and the disagreement is resolved through an arbitration process.
The mutual recognition procedure results in separate national marketing authorizations in the reference member state.
Centralized Procedure: This procedure is
currently mandatory for products developed by means of a biotechnological process and optional for new active substances and other “innovative
medicinal products with novel characteristics.” Under this procedure, an application is submitted to the European Agency for the
Evaluation of Medical Products. Two European Union member states are appointed to conduct an initial evaluation of each application. These
countries each prepare an assessment report that is then used as the basis of a scientific opinion of the Committee on Proprietary Medical
Products. If this opinion is favorable, it is sent to the European Commission, which drafts a decision. After consulting with the member
states, the European Commission adopts a decision and grants a marketing authorization, which is valid throughout the European Union and
confers the same rights and obligations in each of the member states as a marketing authorization granted by that member state.
Decentralized Procedure: The most recently
introduced of the three processes for obtaining approval of new medicinal processes in the European Union, the decentralized procedure
is similar to the mutual recognition procedure described above, but with differences in the timing that key documents are provided to
concerned member states by the reference member state, the overall timing of the procedure and the possibility of, among other things,
“clock stops” during the procedure.
Post-Marketing Requirements
Following approval of a new product, a pharmaceutical
company and the approved product are subject to continuing regulation by the FDA and other regulatory authorities, including, among other
things, monitoring and recordkeeping activities, reporting to applicable regulatory authorities of adverse experiences with the product,
providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and
complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising,
restrictions on promoting drugs for uses or in patient populations not described in the drug’s approved labeling (known as “off-label use”),
and limitations on industry-sponsored scientific and educational activities. Although physicians may prescribe legally available
drugs for off-label uses, drugs may be marketed only for the approved indications and in accordance with the provisions of the approved
labeling. Modifications or enhancements to the products or labeling or changes of site of manufacture are often subject to the approval
of the FDA and other regulators, which may or may not be received or may result in a lengthy review process. The FDA regulations require
the products be manufactured in specific approved facilities and in accordance with current good manufacturing practices, and NDA holders
must list their products and register their manufacturing establishments with the FDA. These regulations also impose certain organizational,
procedural and documentation requirements with respect to manufacturing and quality assurance activities. Drug manufacturers and other
entities involved in the manufacture and distribution of approved drugs are subject to periodic unannounced inspections by the FDA and
certain state agencies for compliance with current good manufacturing practice and other laws. NDA holders using contract manufacturers,
laboratories or packagers are responsible for the selection and monitoring of qualified firms. These firms are subject to inspections
by the FDA at any time, and the discovery of violative conditions could result in enforcement actions that interrupt the operation of
any such facilities or the ability to distribute products manufactured, processed or tested by them.
Other Regulatory Matters
Manufacturing, sales, promotion and other activities
following product approval are also subject to regulation by numerous regulatory authorities in addition to the FDA, including, in the
United States, the Centers for Medicare & Medicaid Services, or CMS, other divisions of the Department of Health and Human
Services, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational
Safety & Health Administration, the Environmental Protection Agency, and state and local governments. These laws and regulations
include:
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The federal healthcare program anti-kickback law which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; |
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Federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other government reimbursement programs that are false or fraudulent. The government may assert that a claim including items or services resulting from a violation of the federal healthcare program anti-kickback law or related to off-label promotion constitutes a false or fraudulent claim for purposes of the federal false claims laws; |
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The Federal Physician Payments Sunshine Act within the Affordable Care Act, or the ACA, and its implementing regulations, require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report on an annual basis information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and certain ownership and investment interests held by physicians and their immediate family members, with the information made publicly available on a searchable website; and |
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The Health Insurance Portability and Accountability Act, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates” — independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. |
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Applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act. |
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The Lanham Act and federal antitrust laws. |
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State law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts. In addition, several states now require prescription drug companies to report expenses relating to the marketing and promotion of drug products and to report gifts and payments to individual physicians in these states. Other states prohibit various other marketing-related activities, and still other states require the posting of information relating to clinical studies and their outcomes. In addition, California, Connecticut, Massachusetts and Nevada require pharmaceutical companies to implement compliance programs and/or marketing codes. Several additional states are considering similar proposals. Compliance with these laws is difficult and time consuming, and companies that do not comply with these state laws face civil penalties. |
Distribution of pharmaceutical products is subject
to additional requirements and regulations, including extensive record-keeping, licensing, traceability, and storage and security requirements
intended to prevent the unauthorized sale of pharmaceutical products.
Third-Party Payer Coverage and Reimbursement
Significant uncertainty exists as to the coverage
and reimbursement status of any of our drug candidates that ultimately may obtain regulatory approval. In both the United States
and foreign markets, our ability to commercialize our product candidates successfully, and to attract commercialization partners for our
product candidates, depends in significant part on the availability of adequate financial coverage and reimbursement from third-party payers,
including, in the United States, governmental payers such as the Medicare and Medicaid programs, managed care organizations, and
private health insurers. Medicare is a federally funded program managed by the CMS, through local fiscal intermediaries and carriers that
administer coverage and reimbursement for certain healthcare items and services furnished to the elderly and disabled. Medicaid is an
insurance program for certain categories of patients whose income and assets fall below state defined levels and who are otherwise uninsured
that is both federally and state funded and managed by each state. The federal government sets general guidelines for Medicaid and each
state creates specific regulations that govern its individual program. Each payer has its own process and standards for determining whether
it will cover and reimburse a procedure or particular product. Private payers often rely on the lead of the governmental payers in rendering
coverage and reimbursement determinations. Therefore, achieving favorable CMS coverage and reimbursement is usually a significant gating
issue for successful introduction of a new product. The competitive position of some of our products will depend, in part, upon the extent
of coverage and adequate reimbursement for such products and for the procedures in which such products are used. Prices at which we or
our customers seek reimbursement for our products can be subject to challenge, reduction or denial by the government and other payers.
The United States Congress and state legislatures
may, from time to time, propose and adopt initiatives aimed at cost containment, which could impact our ability to sell our products and
product candidates profitably. For example, in the first quarter of 2018, President Trump signed a law requiring pharmaceutical companies
to pay for a substantially larger percentage of the coverage gap, or the so-called “donut hole,” between regular and
catastrophic Medicare Part D prescription drug coverage, a change that is estimated to have a multi-billion-dollar effect on
brand-name drug companies. Additional changes could be made in the future to governmental healthcare programs and many other laws
that could significantly impact the success of our products.
The cost of pharmaceuticals continues to generate
substantial governmental and third-party payer interest. We expect that the pharmaceutical industry will experience pricing pressures
due to the trend toward managed healthcare, the increasing influence of managed care organizations and additional legislative proposals.
Our results of operations could be adversely affected by current and future healthcare reforms.
Some third-party payers also require pre-approval of
coverage for new or innovative devices or drugs before they will reimburse healthcare providers that use such drugs. While we cannot predict
whether any proposed cost-containment measures will be adopted or otherwise implemented in the future, the announcement or adoption
of these proposals could have a material adverse effect on our ability to obtain adequate prices for our products and product candidates
and operate profitably.
In addition, in some foreign countries, the proposed
pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country
to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which
their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member
state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability
of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement
limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically,
products launched in the European Union do not follow price structures of the United States and generally tend to be significantly
lower.
Trade Laws
Among other matters, U.S. and foreign anti-corruption,
anti-money laundering, export control, sanctions, and other trade laws and regulations, which are collectively referred to as Trade
Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors,
and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper
payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial
criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud
litigation, reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of government
agencies or government-affiliated hospitals, universities, and other organizations. We also expect our non-U.S. activities to
increase in time. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations,
and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents, or partners,
even if we do not explicitly authorize or have prior knowledge of such activities.
Human Capital-Employees
As of July 23, 2023, we had three employees, all
of which are full-time. Our employees are not represented by labor unions or covered by collective bargaining agreements. We consider
our relationship with our employees to be good.
Corporate Information
We were incorporated as a Delaware corporation
in January 2022 and secured the rights to tecarfarin on April 1, 2022 via an asset purchase agreement (the “Asset Purchase
Agreement”) from HESP LLC. HESP LLC acquired the assets of Espero BioPharma, Inc., or Espero, from Horizon Technology Finance Corporation
and Horizon Credit II LLC (collectively, Horizon), a secured lender of Espero, including tecarfarin and the other assets of Espero in
an assignment for the benefit of creditors. Quang Pham, our Chief Executive Officer, was the Chief Executive Officer of Espero, and served
as a consultant to HESP LLC from July 2020 until December 2021.
Our principal executive offices are located at
822 A1A North, Suite 306, Ponte Vedra, Florida 32082, and our telephone number is (904) 300-0701. Our website address is www.cadrenal.com.
The information contained on, or that can be accessed through, our website is not incorporated by reference into this prospectus, and
you should not consider any information contained on, or that can be accessed through, our website as part of this prospectus or in deciding
whether to purchase our Common Stock.
Facilities
Our corporate headquarters are located at 822
A1A North, Suite 306, Ponte Vedra, Florida 32082, which are leased pursuant to a Lease Agreement dated October 15, 2022 with Veranda
III Partners, Ltd. (the “Lease Agreement”). The Lease Agreement has an initial term of 24 months commencing on November 1,
2022. The monthly rent is $2,167. We believe that these headquarters are adequate for our current operations and needs.
Legal Proceedings
We are not currently a party to any material legal
proceedings. We may, however, in the ordinary course of business face various claims brought by third parties, and we may, from time to
time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relating to employment
matters and the safety or efficacy of our products. Any of these claims could subject us to costly litigation. If this were to happen,
the payment of any such awards could have a material adverse effect on our business, financial condition and results of operations. Additionally,
any such claims, whether or not successful, could damage our reputation and business.
MANAGEMENT
The following table sets forth information concerning
our directors and executive officers, including their ages, as of July 23, 2023. There are no family relationships among any of our directors
or executive officers.
Name |
|
Age |
|
Position |
Executive Officers and Directors |
|
|
|
|
Quang Pham |
|
58 |
|
Chairman and Chief Executive Officer |
Matthew Szot |
|
49 |
|
Chief Financial Officer |
Douglas Losordo |
|
65 |
|
Chief Medical Officer |
|
|
|
|
|
Non-Employee Directors
|
|
|
|
|
Robert Lisicki |
|
56 |
|
Director |
John R. Murphy |
|
73 |
|
Director |
Glynn Wilson |
|
76 |
|
Director |
Steven Zelenkofske |
|
64 |
|
Director |
Quang Pham, Chairman and Chief Executive
Officer
Quang Pham has served as our Chief Executive Officer
since he formed the Company on January 25, 2022. He previously served as Chief Executive Officer, Chairman of the Board of Directors and
founder of Espero BioPharma, Inc. (“Espero”), the previous sponsor of the tecarfarin IND, since its formation in March 2015
until July 2020, at which time a petition for assignment for the benefit of creditors was filed in the Delaware Chancery Court, seeking
an assignment of Espero’s assets. He then served as a consultant to HESP LLC, the assignee of Espero, from July 2020 until December
2021. From February 2012 to August 2015, Mr. Pham was a partner with D+R LATHIAN, LLC, a life sciences multichannel marketing agency.
Prior to joining D+R LATHIAN, he founded and served as Chairman and Chief Executive Officer of Lathian Systems, Inc., a digital and database
marketing company serving the pharmaceutical industry from 2000 until 2003 and from 2008 until 2012 when the company was acquired by D&R
Communications, LLC in February 2012. He has a Bachelor of Arts in Economics from UCLA, and served as a U.S. Marine Corps Officer. We
believe Mr. Pham is qualified to serve on our Board of Directors because of his significant business, mergers and acquisitions, and fundraising
experience, numerous interactions with the FDA, continuous five-year history with tecarfarin development, and his extensive knowledge
of the pharmaceutical industry and our competitors.
Matthew Szot, Chief Financial Officer
Matthew Szot has served as our Chief Financial
Officer since May 2022. From March 2010 to November 2021, Mr. Szot served as Executive Vice President and Chief Financial Officer of S&W
Seed Company, a Nasdaq-listed agricultural seed biotechnology company. Since September 2020, Mr. Szot has served on the Board of Directors
and as Chairman of the Audit and Compensation Committees of INVO Bioscience, Inc., a Nasdaq-listed commercial-stage fertility company.
He also serves on the Board of Directors and serves as Chairman of the Audit Committee of SenesTech, Inc., a Nasdaq-listed life science
company with next-generation technologies for managing animal pest populations through fertility control. From June 2018 to August 2019,
Mr. Szot served on the Board of Directors and as Chairman of the Audit Committee of Eastside Distilling, a Nasdaq-listed craft spirits
company. From 2007 until 2011, Mr. Szot served as the Chief Financial Officer for Cardiff Partners, LLC, a strategic consulting company
that provided executive financial services to various publicly traded and privately held companies. From 2003 to 2006, he served as Chief
Financial Officer of Rip Curl, Inc., a market leader in wetsuit and action sports apparel products. From 1996 to 2003, Mr. Szot was a
Certified Public Accountant with KPMG in the San Diego and Chicago offices and served as an Audit Manager for various publicly traded
companies. Mr. Szot graduated from the University of Illinois, Champaign-Urbana with a BS in Agricultural Economics/Accountancy. He is
a Certified Public Accountant in the State of California. Mr. Szot brings a wealth of knowledge in mergers and acquisitions, corporate
strategy, equity and debt financings, corporate governance, SEC reporting and compliance, and developing and implementing financial and
operational workflows and process improvements. He also has extensive experience in international operations, joint ventures, and technology
license agreements.
Douglas Losordo, M.D., Chief Medical Officer
Douglas Losordo has served as our Chief Medical
Officer since August 8, 2022. Dr. Losordo has worked in the biotech industry developing cell-based therapies for over twenty years. Since
February 2021, he has served on the Board of Directors of Longeveron Inc., a clinical-stage biotechnology company developing cellular
therapies for aging-related and life-threatening conditions. Dr. Losordo also served as Global Head Clinical Development and Operations
of American Regent, Inc., a clinical development pharmaceutical company from June 2021 until August 2022. Prior thereto he served as Chief
Medical Officer of KBP Biosciences Co., Ltd., a biotechnology research and development company, from November 2020 until June 2021 and
as Executive Vice President, Global Head of Research and Development, Chief Medical Officer of Caladrius Biosciences, a clinical-stage
biopharmaceutical company dedicated to the development of cellular therapies designed to reverse chronic disease, from August 2013 until
November 2020. Dr. Losordo has extensive knowledge of clinical, regulatory, manufacturing, supply chain and commercial factors unique
to cellular therapy technologies as a result of his prior industry experience. Dr. Losordo also previously served as a Professor of Medicine
at NYU Langone Medical Center and Northwestern University’s Feinberg School of Medicine. He received his MD from the University
of Vermont College of Medicine, and his B.A. in Zoology from the University of Vermont.
Robert Lisicki
Mr. Lisicki, has served on our Board of Directors
since July 23, 2023. Mr. Lisicki currently serves as an independent consultant and advisor to both public and private pharmaceutical and
biotechnology companies. From October 2022 until March 2023, he served as the Chief Executive Officer and board member of InCarda Therapeutics,
Inc., a privately held clinical stage biopharmaceutical company focused on cardiovascular diseases. Previously, he served as Executive
Vice President and Chief Commercial Officer of Arena Pharmaceuticals (“Arena”) from November 2018 until March 2022, when Arena
was acquired by Pfizer, Inc. Prior to joining Arena, Mr. Lisicki served as General Manager, Vice President Cardio-Metabolic and Inflammation
at Regeneron Pharmaceuticals, Inc. from June 2018 to November 2018, leading the Company’s U.S.-based cardiovascular and inflammation
business, and Senior Vice President of Sales and Marketing and Chief Customer Officer at Daiichi Sankyo, Inc. from August 2014 until February
2018, with responsibility for the company’s U.S.-based cardiovascular and oncology therapeutics. Mr. Lisicki also held several management
positions at Amgen Inc. between 2005 and 2014, including Vice President and General Manager, responsible for a 700+ person sales force
in the U.S. His U.S. leadership experiences included such market shaping products Enbrel and Prolia. During his tenure he also covered
several ex-U.S. regions, and worked as an International Franchise Lead running the development and international strategies and business
plans across Amgen’s portfolio including Nephrology, Cardiology, Bone and Oncology. Mr. Lisicki held various sales and marketing
positions at Johnson & Johnson Corporation. Mr. Lisicki brings over 25 years of experience in biopharmaceutical management, sales
and marketing to the Company. Mr. Lisicki holds a Bachelor of Science degree in Finance and Business Administration from the State University
of New York at Albany. We believe Mr. Lisicki’s substantial experience with cardiovascular therapeutics and commercial experience
in biopharmaceuticals will assist us as we work to complete our drug development and commercialization activities.
John R. Murphy
John R. Murphy has served on our Board of Directors since January 19,
2023. Since 2003, John R. Murphy has served on the Board of Directors of O’Reilly Automotive, Inc., where he served as Chairman
of the Audit Committee from 2003 until 2019. Currently, he serves on the Audit Committee and Human Capital and Compensation Committee
(Chair). Mr. Murphy has also served on the Board of Directors of Summit Materials, Inc. since 2012, where he is currently the Chair of
the Audit Committee. Previously he served as a Director, Audit Committee Chairman, and Member of the Nominating and Governance Committee
of Apria, Inc. (“Apria”) from August 2019 until April 2022. He also served on the Board of Directors of Alight Solutions LLC
and Audit Committee Chairman from February 2020 until May 2022 and DJO Global, Inc. from 2012 until March 2019. Mr. Murphy also previously
served on the Board of Directors of Graham Packaging, Inc. and Accuride Corporation, Inc. He previously served as Interim Chief Financial
Officer of Summit Materials, Inc. in 2013, Senior Vice President and Chief Financial Officer of Smurfit-Stone Container Corporation from
2009 to 2010, and Chief Financial Officer, then President and Chief Operating Officer, then President and Chief Executive Officer with
Accuride Corporation, Inc. from 1998 to 2008. Mr. Murphy holds a Bachelor of Science in Accounting from Pennsylvania State University
and a Master of Business Administration from the University of Colorado, and is a Certified Public Accountant. We believe Mr. Murphy’s
substantial experience guiding public company boards and knowledge and experience as chief financial officer will assist us in navigating
the public reporting process.
Glynn Wilson, Ph.D.
Dr. Glynn Wilson has served on our Board of Directors
since January 19, 2023. He has served on the Board of Directors of Jupiter Wellness, Inc. (“Jupiter”) since November 2018,
serving as Chairman since October 2019. Dr. Wilson also serves as Jupiter’s Chief Scientific Officer since April 2021 and served
as its Head of Research and Development from October 2019 to July 2021. Dr. Wilson previously served as a Director of TapImmune, Inc.
from February 2005 until October, 2018 and as Chief Executive Officer from July 2009 through September 2017. Dr. Wilson also served as
President of Auriga Laboratories, Inc. from June 1, 2005 through March 13, 2006, and as Chief Scientific Officer from March 13, 2016 through
August 25, 2006. He was the Chief Scientific Officer at Tacora Corporation from 1994 to 1997 and was the Vice-President, R&D, at Access
Pharmaceuticals from 1997 to 1998. Dr. Wilson was Research Area Head, Cell and Molecular Biology in Advanced Drug Delivery at Ciba-Geigy
Pharmaceuticals from 1984 – 1989 and Worldwide Head of Drug Delivery at SmithKline Beecham from 1989 to 1994. He was a faculty member
at Rockefeller University, New York, in the laboratory of the Nobel Laureates, Sanford Moore and William Stein, from 1974 to 1979. Dr.
Wilson is a recognized leader in the development of drug delivery systems and has been involved in taking lead products & technologies
from concept to commercialization.
Dr. Wilson has a Ph.D. in Biochemistry and conducted
medical research at The Rockefeller University, New York. We believe that Dr. Wilson’s extensive background of success in corporate
management and product development, with tenures in both multinational and start-up biotech organizations, will assist us as we work to
complete our drug development and commercialization activities.
Steven Zelenkofske, D.O.
Dr. Steven Zelenkofske has served on our Board
of Directors since January 19, 2023. Dr. Zelenkofske has served on the Board of Directors of Dinaqor AG since May 2020. He has served
as Chief Medical Officer of SwanBio Therapeutics since June 1, 2020. Dr. Zelenkofske is also an advisor to Veralox Therapeutics, Inc.,
as Chair of the Scientific Advisory Board, a position he has held since March 2020. Previously, he served as Executive Vice President
and Chief Medical Officer of Achillion Pharmaceuticals, Inc. from August 2018 until April 2020. Dr. Zelenkofske also served as Chief Medical
Officer of uniQure N.V., from June 2017 to August 2018. Prior to joining uniQure, N.V., Dr. Zelenkofske was Vice President and Therapeutic
Head of Cardiovascular/Metabolism for AstraZeneca, a biopharmaceutical company, from November 2014 to June 2017. From January 2009 to
November 2014, Dr. Zelenkofske was Senior Vice President Clinical and Medical Affairs and Chief Medical Officer of Regado Biosciences,
Inc., a biotechnology company. Dr. Zelenkofske has held leadership positions at Sanofi-Aventis, Boston Scientific, a medical device company,
and Novartis Pharmaceuticals, a global healthcare company. Dr. Zelenkofske holds Bachelor of Science and Master of Science degrees from
Emory University and a Doctor of Osteopathic Medicine degree from the Philadelphia College of Osteopathic Medicine. He conducted his graduate
medical education at the Philadelphia College of Osteopathic Medicine and is board-certified in internal medicine, cardiology and cardiac
electrophysiology. We believe that Dr. Zelenkofske’s knowledge and experience working in the biotech and pharmaceutical space will
assist us as we work to complete our drug development and commercialization activities.
Selection of Officers
Our executive officers serve at the discretion
of our Board of Directors. There are no familial relationships among our directors and executive officers.
Board Composition
Pursuant to our amended and restated certificate of incorporation,
our Board of Directors is divided into three classes — Class I, Class II, and Class III — with each class serving staggered
three-year terms and subject to the terms of our amended and restated certificate of incorporation and amended and restated bylaws, our
Board of Directors consists of five members, as a classified board of directors. As a result, only one class of directors will be elected
at each annual meeting of our stockholders, with the other classes continuing for the remainder of their respective three-year terms.
The terms of the directors will expire upon the election and qualification of successor directors at the annual meeting of stockholders
to be held during 2023 for the Class I directors, 2024 for the Class II directors and 2025 for the Class III directors. Our directors
are divided among the three classes as follows:
|
● |
the Class I directors are Quang Pham and Glynn Wilson and their terms will expire at the annual meeting of stockholders to be held in 2023; |
|
● |
the Class II directors are Robert Lisicki and John
Murphy and their terms will expire at the annual meeting of stockholders to be held in 2024; and |
|
● |
the Class III director is Steven Zelenkofske and his term will expire at the annual meeting of stockholders to be held in 2025. |
Upon expiration of the term of a class of directors,
new directors for that class will be elected for three-year terms at the annual meeting of stockholders during the year in which that
term expires. Each director’s term shall continue until the election and qualification of his or her successor, or the director’s
earlier death, resignation or removal. Any additional directorships resulting from an increase in the number of authorized directors will
be distributed among the three classes so that, as nearly as possible, each class will consist of one-third of the directors.
The classification of our Board of Directors may
have the effect of delaying or preventing a change of our management, a change of control or other corporate actions. Under Delaware law,
our amended and restated certificate of incorporation our directors may be removed only for cause.
Principal Investigator
Sean Pokorney, M.D.
Sean Pokorney has been designated as our Principal
Investigator. Dr. Pokorney is a cardiologist, electrophysiologist and researcher specializing in patients with ESRD and AFib. He is an
Assistant Professor of Medicine at Duke University and is a member of the Duke Clinical Research Institute. We entered into a Scientific
Advisory Board and Consulting Agreement with Dr. Pokorney (“Pokorney Agreement”), dated June 15, 2022, which provides that
he shall be granted stock options, pursuant to the Cadrenal Therapeutics, Inc. 2022 Equity Incentive Plan, to purchase 100,000 shares
of our Common Stock at an exercise price per share equal to the fair market value per share of the Company’s Common Stock on the
date of the grant, which stock options will vest over a three-year vesting schedule. The Pokorney Agreement further provides that we shall
pay Dr. Pokorney at the rate of $650 per hour for services that exceed the scope of work of general members of the Scientific Advisory
Board.
Scientific Advisory Board (SAB)
We intend that our Scientific Advisory Board will
work with our management team in planning, developing and executing further scientific, clinical, and research and development initiatives
and strategies. Our scientific advisory board is comprised of the following individuals, who have significant experience in the field
of cardiovascular medicine:
Christopher Granger, MD
|
● |
Professor of Medicine in the Division of Cardiology at Duke University |
|
● |
Director of Cardiac Care Unit for Duke University Medical Center |
|
● |
Member, Duke Clinical Research Institute (DCRI) |
C. Michael Gibson, MS, MD
|
● |
CEO of not-for profit Baim/PERFUSE Research Institutes |
|
● |
Harvard University Professor |
|
● |
Cardiologist at Beth Israel Deaconess Medical Center of Boston |
|
● |
Founder and Chairman WikiDoc.org |
Richard Whitlock, MD, PhD
|
● |
Cardiac Surgeon and Associate Professor at Population Health Research Institute, McMaster University Medical Center |
|
● |
Investigator, Population Health Research Institute |
A. Michael Lincoff, MD
|
● |
Vice Chairman, Department of Cardiovascular Medicine, Cleveland Clinic |
|
● |
Director of Clinical Research, Lerner Research Institute |
Wolfgang C. Winkelmayer, MD, MPH, ScD
|
● |
Chief, Section of Nephrology and Professor of Medicine, Baylor College of Medicine |
|
● |
Director, Selzman Institute for Kidney Health at Baylor College of Medicine |
Elaine Hylek, MD, MPH
|
● |
Professor of Medicine at the Boston University School of Medicine |
|
● |
Director, Thrombosis and Anticoagulation Service at Boston Medical Center |
|
● |
Researcher focused on anticoagulation and stroke prevention in AFib |
Director Independence
Under the rules of the Nasdaq Stock Market, independent directors must
comprise a majority of our Board of Directors. The rules of the Nasdaq Stock Market, as well as those of the SEC, impose several requirements
with respect to the independence of our directors. Our Board of Directors has conducted a review of its proposed composition, the composition
of its proposed committees and the independence of each director in accordance with these rules. Based upon information requested from
and provided by each director concerning his or her background, employment and affiliations, including family relationships, our Board
of Directors has determined that Robert Lisicki, John R. Murphy, Dr. Steven Zelenkofske, and Dr. Glynn Wilson do not have relationships
that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director and that each of these
directors is “independent” as that term is defined under the rules of the Nasdaq Stock Market and the SEC. In making this
determination, our Board of Directors considered relationships that each director has with the Company, including the transactions described
under the section entitled “Certain Relationships and Related Party Transactions.”
Committees of the Board of Directors
Our Board of Directors has established an Audit
Committee, a Compensation Committee and a Nominating and Corporate Governance Committee, each of which has the composition and responsibilities
described below. Each committee operates under a written charter that satisfies the applicable rules of the SEC and the listing standards
of the Nasdaq Stock Market, copies of which are available on our website at www.cadrenal.com. Members will serve on these committees
until their resignation or until otherwise determined by our Board of Directors. From time to time, our Board of Directors may establish
other committees to facilitate the management of our business as it sees fit and in accordance with applicable law and our corporate governance
documents.
The following table shows the directors who are
currently members or Chairman of each of the Audit Committee, Compensation Committee, and Nominating and Governance Committee.
Board Members |
|
Audit
Committee |
|
Compensation
Committee |
|
Nominating
and
Governance
Committee |
Quang Pham |
|
— |
|
— |
|
— |
Robert Lisicki |
|
— |
|
Member |
|
Member |
John Murphy |
|
Chair |
|
Member |
|
— |
Glynn Wilson |
|
Member |
|
— |
|
Chair |
Steven Zelenkofske |
|
Member |
|
Chair |
|
Member |
Audit Committee. Our Audit Committee
consists of John Murphy, Dr. Steven Zelenkofske and Dr. Glynn Wilson, with John Murphy serving as the Chair of the Audit Committee. Our
Board of Directors has determined that all of the directors who serve on our Audit Committee are independent within the meaning of the
rules and regulations of the Nasdaq Stock Market and Rule 10A-3 under the Exchange Act. In addition, our Board of Directors has determined
that John Murphy qualifies as an audit committee financial expert within the meaning of SEC regulations and meets the financial sophistication
requirements of the Nasdaq Stock Market. The primary purpose of the audit committee is to oversee the quality and integrity of our accounting
and financial reporting processes and the audit of our financial statements. Specifically, the audit committee will:
|
● |
select and hire the independent registered public accounting firm to audit our financial statements; |
|
● |
help to ensure the independence and performance of the independent registered public accounting firm; |
|
● |
approve audit and non-audit services and fees; |
|
● |
review financial statements and discuss with management and the independent registered public accounting firm our annual audited and quarterly financial statements, the results of the independent audit and the quarterly reviews and the reports and certifications regarding internal controls over financial reporting and disclosure controls; |
|
● |
prepare the audit committee report that the SEC requires to be included in our annual proxy statement; |
|
● |
review reports and communications from the independent registered public accounting firm; |
|
● |
review the adequacy and effectiveness of our internal controls and disclosure controls and procedure; |
|
● |
review our policies on risk assessment and risk management; |
|
● |
review and approve related party transactions; and |
|
● |
establish and oversee procedures for the receipt, retention and treatment of accounting related complaints and the confidential submission by our employees of concerns regarding questionable accounting or auditing matters. |
Compensation Committee. Our Compensation
Committee consists of Dr. Steven Zelenkofske, Robert Lisicki, and John Murphy, with Dr. Steven Zelenkofske serving as the Chair of the
Compensation Committee. Our Board of Directors has determined that all of the directors who serve on our compensation committee are independent
under the listing standards, are “non-employee directors” as defined in rule 16b-3 promulgated under the Exchange Act and
are “outside directors” as that term is defined in Section 162(m) of the Internal Revenue Code of 1986, as amended, or the
Code. Our compensation committee oversees our compensation policies, plans and benefits programs. The compensation committee will also:
|
● |
oversee our overall compensation philosophy and compensation policies, plans and benefit programs; |
|
● |
review and recommend to our board of directors for approval compensation for our executive officers and directors; |
|
● |
prepare the compensation committee report that the SEC would require to be included in our annual proxy statement if we were no longer deemed to be an emerging growth company or a smaller reporting company; and |
|
● |
administer our equity compensation plans. |
Nominating and Corporate Governance Committee.
Our Nominating and Corporate Governance Committee consists of Dr. Glynn Wilson, Robert Lisicki and Dr. Steven Zelenkofske, with
Dr. Glynn Wilson serving as the Chair of the Nominating and Corporate Governance Committee. The Nominating and Corporate Governance Committee
oversees and assists our Board of Directors in reviewing and recommending nominees for election as directors. All members who serve on
the Nominating and Corporate Governance Committee are independent directors as defined under the listing standards of the Nasdaq Stock
Market. Specifically, the corporate governance and nominating committee will:
|
● |
identify, evaluate and make recommendations to our board of directors regarding nominees for election to our board of directors and its committees, including consideration of recommendations for election to the Board of Directors by stockholders if submitted in a timely manner in accordance with the procedures set forth in our bylaws; |
|
● |
consider and make recommendations to our board of directors regarding the composition of our board of directors and its committees; |
|
● |
review developments in corporate governance practices; |
|
● |
evaluate the adequacy of our corporate governance practices and reporting; and |
|
● |
evaluate the performance of our board of directors and of individual directors. |
Candidates for director should have certain minimum
qualifications, including the ability to understand basic financial statements, being over 21 years of age, having relevant business experience
(taking into account the business experience of the other directors), and having high moral character. The Nominating and Corporate Governance
Committee retains the right to modify these minimum qualifications from time to time.
In evaluating an incumbent director whose term
of office is set to expire, the Nominating and Corporate Governance Committee reviews such director’s overall service to the Company
during such director’s term, including the number of meetings attended, level of participation, quality of performance, and any
transactions with the Company engaged in by such director during his term.
When selecting a new director nominee, the Nominating
and Corporate Governance Committee first determines whether the nominee must be independent for Nasdaq purposes or whether the candidate
must qualify as an “audit committee financial expert.” The Nominating and Corporate Governance Committee then uses its network
of contacts to compile a list of potential candidates, but may also engage, if it deems appropriate, a professional search firm to assist
in the identification of qualified director candidates. The Nominating and Corporate Governance Committee also will consider nominees
recommended by our stockholders. The Nominating and Corporate Governance Committee does not distinguish between nominees recommended by
our stockholders and those recommended by other parties. The Nominating and Corporate Governance Committee evaluates the suitability of
potential nominees, taking into account the current board composition, including expertise, diversity and the balance of inside and independent
directors. The Nominating and Corporate Governance Committee does not have a set policy or process for considering diversity in identifying
nominees, but endeavors to establish a diversity of background and experience in a number of areas of core competency, including business
judgment, management, accounting, finance, knowledge of our industry, strategic vision, research and development and other areas relevant
to our business. In considering any person recommended by one of our stockholders, the Nominating and Corporate Governance Committee will
look for the same qualifications that it looks for in any other person that it is considering for a position on the Board of Directors.
Compensation Committee Interlocks and Insider
Participation
No member of our Compensation Committee will be
serving, or will have ever served, as an officer or employee of ours. None of our executive officers currently serves, or has served during
the last completed year, as a member of the Board of Directors, Compensation Committee or other board committee performing equivalent
functions of any entity that has one or more executive officers who served as a member of our Board of Directors during the last completed
year.
Code of Business Conduct and Ethics
We have adopted a code of business conduct and
ethics that is applicable to all of our employees, officers and directors. The full text of our code of business conduct and ethics will
be available on our website at www.cadrenal.com. If we amend or grant any waiver from a provision of our code of ethics that applies
to our directors or executive officers, we will publicly disclose such amendment or waiver on our website and as required by applicable
law, including by filing a Current Report on Form 8-K.
Limitation of Liability and Indemnification
Our amended and restated bylaws provide indemnification
for our directors and executive officers to the fullest extent permitted by the Delaware General Corporation Law. The indemnification
agreements that we have entered into with each of our current executive officers and directors may, in some cases, be broader than the
specific indemnification provisions contained under Delaware law.
In addition, as permitted by Delaware law, our
amended and restated certificate of incorporation includes provisions that eliminate the personal liability of our directors and officers
for monetary damages resulting from breaches of certain fiduciary duties as a director or officer, as applicable, except to the extent
such an exemption from liability thereof is not permitted under the Delaware General Corporation Law. The effect of these provisions is
to restrict our rights and the rights of our stockholders in derivative suits to recover monetary damages against a director or officer
for breach of fiduciary duties as a director or officer, subject to certain exceptions in which case the director or officer would be
personally liable. An officer may not be exculpated for any action brought by or in the right of the corporation. A director may not be
exculpated for improper distributions to stockholders. Further, pursuant to Delaware law a director or officer may not be exculpated for:
|
● |
any breach of his or her duty of loyalty to us or to our stockholders; |
|
● |
acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law; and |
|
● |
any transaction from which the director or officer derived an improper personal benefit. |
If Delaware law is amended to authorize corporate
action further eliminating or limiting the personal liability of directors and officers, then the liability of our directors and officers
will be eliminated or limited to the fullest extent permitted by Delaware law, as so amended. Our certificate of incorporation does not
eliminate the duty of care owed by our directors and officers and, in appropriate circumstances, equitable remedies, such as injunctive
or other forms of non-monetary relief, remain available under Delaware law. This provision also does not affect the responsibilities of
directors and officers under any other laws, such as the federal securities laws or other state or federal laws. Under our amended and
restated bylaws, we will also be empowered to purchase insurance on behalf of any person whom we are required or permitted to indemnify.
In the case of an action or proceeding by or in
the right of our company or any of our subsidiaries, no indemnification will be provided for any claim where a court determines that the
indemnified party is prohibited from receiving indemnification. We believe that these charter and bylaw provisions are necessary to attract
and retain qualified persons as directors and officers.
The limitation of liability and indemnification
provisions in our amended and restated certificate of incorporation and amended and restated bylaws may discourage stockholders from bringing
a lawsuit against directors and officers for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigation
against directors and officers, even though an action, if successful, might benefit us and our stockholders. Moreover, a stockholder’s
investment may be harmed to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these
indemnification provisions.
Insofar as indemnification for liabilities arising
under the Securities Act may be permitted to our directors, officers and controlling persons pursuant to the foregoing provisions, or
otherwise, we have been advised that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities
Act, and is, therefore, unenforceable. There is no pending litigation or proceeding naming any of our directors or officers as to which
indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification
by any director or officer.
We have entered into separate indemnification
agreements with each of our current executive officers and intend to enter, into separate indemnification agreements with each of our
directors and executive officers, in addition to the indemnification that will be provided for in our amended and restated bylaws. The
indemnification agreements and our amended and restated bylaws require us to indemnify our directors and executive officers to the fullest
extent permitted by Delaware law. See the section titled “Description of Securities — Limitations on Liability and Indemnification
of Officers and Directors” for additional information.
EXECUTIVE COMPENSATION
Executive Officers and Directors
Our named executive officers for the year ended
December 31, 2022, which consist of our principal executive officer and the next most highly compensated executive officers, are:
|
● |
Quang Pham, Chairman and Chief Executive Officer |
|
● |
Matthew Szot, Chief Financial Officer |
|
● |
Douglas Losordo, Chief Medical Officer |
Summary Compensation Table
The following table shows compensation awarded
to or earned by our named executive officers, for the period from January 25, 2022 (inception) to December 31, 2022.
Name and Principal Position | |
Salary ($) | | |
Bonus ($)(1) | | |
Stock Award ($)(2) | | |
Option Awards ($)(2) | | |
Non-Equity Incentive Plan Compensation ($) | | |
All Other Compensation ($) | | |
Total ($) | |
Quang Pham Chief Executive Officer(6) | |
$ | 350,000 | | |
$ | 337,500 | | |
| — | | |
$ | — | | |
$ | — | | |
$ | 128,723 | (3) | |
$ | 816,223 | |
Matthew Szot Chief Financial Officer(7) | |
$ | — | | |
$ | 187,500 | | |
| — | | |
$ | — | | |
$ | — | | |
$ | 172,105 | (4) | |
$ | 359,605 | |
Douglas Losordo Chief Medical Officer(8) | |
$ | — | | |
| — | | |
| — | | |
$ | 625,200 | | |
$ | — | | |
$ | 23,360 | (5) | |
$ | 648,560 | |
(1) |
Bonuses were accrued as of December 31, 2022, but such bonuses were paid in February 2023. |
(2) |
In accordance with SEC rules, this column reflects the aggregate fair value of the stock and option awards granted as of their respective grant dates in accordance with Financial Accounting Standard Board Accounting Standards Codification Topic 718 for stock-based compensation transactions (ASC 718). The valuation assumptions used in determining such amounts are described in Note 1 and Note 10 to our audited financial statements included elsewhere in this prospectus. These amounts do not correspond to the actual value that may be realized by the Named Executive Officers upon vesting or exercise of such awards. |
(3) |
All other compensation for Mr. Pham includes $115,000 of accrued but unpaid consulting fees due to Phamace, LLC, a consulting firm of which Quang Pham, our Chief Executive Officer, is the sole member. Other compensation also includes $13,723 for the cost of his monthly premiums for health insurance. |
(4) |
Amount represents Mr. Szot’s monthly consulting fee of $22,500 from May 17, 2022 through December 31, 2022 plus $2,836 of premiums for health insurance. |
(5) |
Amount represents Mr. Losordo’s consulting fees from August 8, 2022 through December 31, 2022. |
(6) |
Mr. Pham became our Chief Executive Officer on January 25, 2022 (inception). |
(7) |
Mr. Szot became our Chief Financial Officer on May 17, 2022. |
(8) |
Mr. Losordo became our Chief Medical Officer on August 8, 2022. |
Agreements with Our Named Executive Officers
Quang Pham Employment Agreement
We entered into an employment agreement with Quang
Pham, our Chief Executive Officer, on March 1, 2022. Mr. Pham’s employment is at-will. Mr. Pham’s annual base salary pursuant
to the employment agreement was initially $420,000, which increased to $675,000 upon the completion of our initial public offering. Mr.
Pham is eligible for an annual target bonus of up to 50% of his base salary, with the actual amount of the bonus, if any, based upon the
achievement by Mr. Pham and us of the applicable performance targets and goals as set by our board of directors or our compensation committee,
with individual performance targets determined in consultation with Mr. Pham. A bonus of $337,500 was paid to Mr. Pham in February 2023.
Pursuant to Mr. Pham’s employment agreement,
we will need to provide 90 days’ written notice to terminate his employment without cause. If Mr. Pham resigns for Good Reason,
as such term is defined in the employment agreement, or is terminated without cause (as such terms are defined below), he is entitled
to (i) a lump sum payment equal to 24 months of his base salary, (ii) a lump sum payment equal to his target bonus for the calendar year
in which his termination date occurs, (iii) full acceleration of any outstanding equity or equity-based awards that he has with respect
to us or any of our affiliates as of his termination date, (iv) extension of exercisability for the full term of any stock option, and
(v) payment of his full COBRA premiums for 24 months following his termination date, if applicable conditions are met.
Mr. Pham is required to provide us 90 days’
written notice of the condition that qualifies as a Good Reason for his resignation and we will have 30 days from receipt of such notice
to remedy such condition. If Mr. Pham fails to provide the required notice such that we have the opportunity to cure the condition prior
to his resignation, or if he resigns more than nine months after the initial existence of the condition, his resignation shall not be
deemed for Good Reason.
If we terminate Mr. Pham’s employment for
Cause, as such term is defined in the employment agreement, or if Mr. Pham voluntarily terminates his employment without Good Reason upon
30 days written notice to us, Mr. Pham shall be entitled to receive Accrued Obligations, as such term is defined in the employment agreement
and which includes earned, but unpaid, base salary, accrued, but unused, vacation, and vested benefits, as of the date of termination.
Pursuant to Mr. Pham’s employment agreement,
if his employment is terminated due to his death or disability (as defined in the employment agreement), he is entitled to (i) a lump
sum payment equal to twelve months of his base salary, (ii) full acceleration of any outstanding equity or equity-based awards that he
has with respect to us or any of our affiliates as of his termination date, and (iii) Accrued Obligations.
Matthew Szot Employment Agreement
Upon completion of the initial public offering,
we entered into an employment agreement with Matthew Szot, our Chief Financial Officer, dated January 24, 2023. Pursuant to the employment
agreement, as amended on May 25, 2023, he receives an annual salary of $415,000 and is eligible for an annual target bonus of up to 50%
of his base salary, with the actual amount of the bonus, if any, based upon the achievement of Mr. Szot and us of the applicable performance
targets and goals as set by our board of directors. A cash bonus of $187,500 was paid to Mr. Szot in February 2023.
Pursuant to Mr. Szot’s employment agreement,
we will need to provide 90 days’ written notice to terminate his employment without Cause, as such term is defined in the employment
agreement. If Mr. Szot resigns for Good Reason, as such term is defined in the employment agreement, or is terminated without Cause, unrelated
to a Change of Control, as such term is defined in the employment agreement, he is entitled to (i) continuation of his base salary in
effect immediately prior to termination for a period of 12 months, (ii) a lump sum payment equal to his target bonus for the calendar
year in which his termination date occurs, (iii) full acceleration of any outstanding equity or equity-based awards as of his termination
date, (iv) extension of exercisability for the full term of any stock option, and (v) payment of his full COBRA premiums for 12 months
following his termination date, if applicable conditions are met.
Mr. Szot will be required to provide us 90 days’
written notice of the condition that qualifies as a Good Reason for his resignation and we will have 30 days from receipt of such notice
to remedy such condition. If Mr. Szot fails to provide the required notice such that we do not have the opportunity to cure the condition
prior to his resignation, or if he resigns more than nine months after the initial existence of the condition, his resignation shall not
be deemed for Good Reason.
If at any time during a Change of Control Period,
as such term is defined in the employment agreement, Mr. Szot’s employment is terminated without Cause or Mr. Szot resigns for Good
Reason, he is entitled to: (i) a lump sum payment equal to 12 months of his base salary in effect immediately prior to termination plus
his target bonus for the fiscal year in which his termination date occurs; (ii) full acceleration of any outstanding equity or equity-based
awards as of his termination date; (iii) extension of exercisability for the full term of any stock option; and payment of his full COBRA
premiums for 12 months following his termination date, if applicable conditions are met.
If we terminate Mr. Szot’s employment for
Cause, or if Mr. Szot voluntarily terminates his employment without Good Reason upon 30 days written notice to us, Mr. Szot shall be entitled
to receive Accrued Obligations, as such term is defined in the employment agreement, as of the date of termination.
Pursuant to Mr. Szot’s employment agreement,
if his employment is terminated due to his death or Disability (as defined in the employment agreement), he is entitled to (i) a lump
sum payment equal to twelve months of his base salary, (ii) full acceleration of any outstanding equity or equity-based awards that he
has with respect to us or any of our affiliates as of his termination date; and (iii) Accrued Obligations.
Douglas Losordo Employment Agreement
Upon completion of the initial public offering,
the Company entered into an employment agreement with Douglas Losordo, effective January 24, 2023. Pursuant to the employment agreement,
Dr. Losordo continues to serve as our Chief Medical Officer and receives an annual base salary of $425,000, with an annual targeted cash
bonus of 40% of his base salary.
Pursuant to Dr. Losordo’s employment agreement,
we need to provide 90 days’ written notice to terminate his employment without Cause, as such term is defined in the employment
agreement. If Dr. Losordo resigns for Good Reason, as such term is defined in the employment agreement, or is terminated without Cause,
unrelated to a Change of Control, as such term is defined in the employment agreement, he is entitled to (i) continuation of his base
salary in effect immediately prior to termination for a period of 6 months, (ii) a lump sum payment equal to 50% of his target bonus for
the calendar year in which his termination date occurs, (iii) full acceleration of any outstanding equity or equity-based awards as of
his termination date, (iv) extension of exercisability for the full term of any stock option, and (v) payment of his full COBRA premiums
for 6 months following his termination date, if applicable conditions are met.
Dr. Losordo will be required to provide us 90
days’ written notice of the condition that qualifies as a Good Reason for his resignation and we will have 30 days from receipt
of such notice to remedy such condition. If Dr. Losordo fails to provide the required notice such that we do not have the opportunity
to cure the condition prior to his resignation, or if he resigns more than nine months after the initial existence of the condition, his
resignation shall not be deemed for Good Reason.
If at any time during a Change of Control Period,
as such term is defined in the employment agreement, Dr. Losordo’s employment is terminated without Cause or Dr. Losordo resigns
for Good Reason, he is entitled to: (i) a lump sum payment equal to 12 months of his base salary in effect immediately prior to termination
plus his target bonus for the fiscal year in which his termination date occurs; (ii) full acceleration of any outstanding equity or equity-based
awards as of his termination date, (iii) extension of exercisability for the full term of any stock option; and (iv) payment of his full
COBRA premiums for 12 months following his termination date, if applicable conditions are met.
If we terminate Dr. Losordo’s employment
for Cause, or if Dr. Losordo voluntarily terminates his employment without Good Reason upon 30 days written notice to us, Dr. Losordo
shall be entitled to receive Accrued Obligations, as such term is defined in the employment agreement, as of the date of termination.
Outstanding Equity Awards at Fiscal Year End
The following table sets forth information concerning
the number of shares of Common Stock underlying outstanding equity incentive awards for each of our executive officers as of December
31, 2022:
| |
Option Awards | |
Stock Awards | |
Name | |
Grant Date | |
| Number of Securities Underlying Unexercised Options Exercisable (#) | | |
| Number of Securities Underlying Unexercised Options Unexercisable (#) | | |
| Option Exercise Price ($) | |
Option Expiration Date | |
Number of Shares or Units of Stock
not yet
Vested (#) | |
| Market Value of Shares or Units not yet Vested ($) | |
Douglas Losordo | |
08/18/2022(1) | |
| 50,000 | | |
| 250,000 | | |
| 0.64 | |
08/17/2032 | |
— | |
| — | |
(1) |
These options vest quarterly over a period of three years commencing October 1, 2022. |
Equity Incentive Plans
2022 Initial Equity Incentive Plan
We adopted the Cadrenal Therapeutics, Inc. 2022
Equity Incentive Plan, or the Initial Plan, on July 11, 2022, which was later amended and restated on October 16, 2022, for purposes of
clarifying the application of certain of the rules of the Initial Plan to awards approved before such amendment and restatement of the
Initial Plan and to facilitate the transition to the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan for the issuance
and approval of awards. The principal provisions of the Initial Plan are summarized below. On October 16, 2022, the Board adopted, and
our stockholders approved, the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan, (the “2022 Plan”), which
is a successor to and continuation of the Initial Plan and became effective on January 19, 2023. The 2022 Plan replaced the Initial Plan,
except with respect to awards outstanding under the Initial Plan, and no further awards will be available for grant under the Initial
Plan.
Administration
The Initial Plan vested broad powers in a committee
to administer and interpret the Initial Plan. Our board of directors has initially been designated to administer the Initial Plan. Except
when limited by the terms of the Initial Plan, our board of directors has the authority to, among other things, accelerate the vesting
or exercisability of an award. In its discretion, board of directors may delegate all or part of its authority and duties with respect
to granting awards to one or more of our officers, subject to certain limitations and provided applicable law so permits.
Our board of directors may amend any outstanding
award at any time; provided, however, that no such amendment or termination may adversely affect awards then outstanding without the holder’s
permission. Additionally, as described more fully below, neither the board of directors nor any committee designated to administer the
Initial Plan, or the Administrator, is permitted to reprice outstanding options or stock appreciation rights without shareholder consent.
Eligibility
Any of our employees, directors, consultants,
and other service providers, or those of our affiliates, were eligible to participate in the Initial Plan and could have been selected
by the Administrator to receive an award.
Vesting
The Administrator determines the vesting conditions
for awards. These conditions may include the continued employment or service of the participant, the attainment of specific individual
or corporate performance goals, or other factors as determined in the Administrator’s discretion.
Shares of Stock Available for Issuance
Subject to certain adjustments, the maximum number
of shares of Common Stock that could have been issued under the Initial Plan in connection with awards was 2,000,000 shares, of which
810,000 remained available for issuance as of the date the 2022 Plan became effective. All outstanding awards under the Initial Plan remain
outstanding but no further grants will be made under the Initial Plan.
In the event of any merger, consolidation, reorganization,
recapitalization, stock split, reverse stock split, split up, spin-off, combination of shares, exchange of shares, stock dividend, dividend
in kind, or other like change in capital structure (other than ordinary cash dividends), or other similar corporate event or transaction
that affects our Common Stock, the Administrator shall make adjustments to the number and kind of shares covered under outstanding Initial
Plan awards as it determines appropriate and equitable.
Shares subject to Initial Plan awards that expire
without being fully exercised or that are otherwise forfeited, cancelled or terminated may be made available for issuance under the 2022
Plan. In addition, shares withheld in settlement of a tax withholding obligation, or in satisfaction of the exercise price payable upon
exercise of an option, will become available for issuance under the 2022 Plan.
Change of Control
In the event of a change of control, unless otherwise
provided in a grant agreement, employment agreement or other agreement between the Company and the participant, and unless otherwise determined
by an affirmative vote of a majority of the board of directors prior to the occurrence of such change of control: (i) all outstanding
stock options and stock appreciation rights which have been outstanding for at least six months shall become exercisable in full, whether
or not otherwise exercisable at such time, and any such stock option and stock appreciation right shall remain exercisable in full thereafter
until it expires pursuant to its terms; and (ii) all restrictions and deferral limitations contained in restricted stock and restricted
stock unit awards granted under the Initial Plan shall lapse and the shares of stock subject to such awards shall be distributed to the
participant within thirty (30) days of the change of control to the extent permitted under Section 409A of the Code. In addition, in the
event of a change of control, unless otherwise specifically prohibited under applicable laws or by the rules and regulations of any governing
governmental agencies or national securities exchanges, or unless the board of directors or the Administrator shall specify otherwise
in the applicable award agreement, the Administrator is authorized (but not obligated) to make any of the following adjustments (or any
combination thereof) in the terms and conditions of outstanding awards: (a) continuation or assumption of such outstanding awards under
the Initial Plan by the Company (if it is the surviving company or corporation) or by the surviving company or corporation or its parent;
(b) substitution by the surviving company or corporation or its parent of equity, equity-based and/or cash awards with substantially the
same terms for outstanding awards (to the extent permitted under Section 409A of the Code), including, in the case of options, substitution
by the surviving company or corporation or its parent of restricted stock or other equity in an amount equal to the intrinsic value of
such options; (c) accelerated exercisability, vesting and/or lapse of restrictions under outstanding awards immediately prior to the occurrence
of such event; (d) upon written notice, provide that any outstanding awards must be exercised, to the extent then exercisable, during
a reasonable period of time immediately prior to the scheduled consummation of the event or such other period as determined by the Administrator
(contingent upon the consummation of the event), and at the end of such period, such awards shall terminate to the extent not so exercised
within the relevant period; and (e) cancellation of all or any portion of outstanding awards for fair value (in the form of cash, stock,
other property or any combination thereof) as determined in the sole discretion of the Administrator and which value (for example, in
the case of options that are not in the money) may be zero.
Repricing
The Administrator cannot without obtaining prior
approval of our stockholders, reduce the exercise price in effect for outstanding options under the Initial Plan.
Miscellaneous
Generally, awards granted under the Initial Plan
shall be nontransferable except by will or by the laws of descent and distribution. No participant shall have any rights as a stockholder
with respect to shares covered by options or restricted stock units, unless and until such awards are settled in shares of Common Stock.
The Company’s obligation to issue shares or to otherwise make payments in respect of Initial Plan awards will be conditioned on
the Company’s ability to do so in compliance with all applicable laws and exchange listing requirements. The awards will be subject
to our recoupment and stock ownership policies, as may be in effect from time to time.
2022 Successor Equity Incentive Plan
In October 2022, the Board adopted, and our stockholders
approved, the 2022 Successor Equity Incentive Plan, as a successor to and continuation of the Initial Plan, which became effective on
January 19, 2023. All outstanding awards under the Initial Plan remain outstanding but no further grants will be made under the Initial
Plan. The shares of Common Stock underlying any awards under the 2022 Plan and the Initial Plan that are forfeited, canceled or otherwise
terminated, other than by exercise, will be added back to the shares of Common Stock available for issuance under the 2022 Plan. In addition,
if any shares subject to an award under the 2022 Plan and the Initial Plan are tendered or withheld by the Company to satisfy any exercise
price or tax withholding obligation, such tendered or withheld shares will be added back to the shares of Common Stock available for issuance
under the 2022 Plan. Shares of Common Stock repurchased on the open market will not be added back to the shares of Common Stock available
for issuance under the 2022 Plan. The principal purpose of the 2022 Plan is to attract, retain and incentivize the Company’s employees
and other service providers through the granting of certain stock-based awards, including performance-based awards. The material terms
of the 2022 Plan are summarized below.
Administration
The 2022 Plan vests broad powers in a committee
to administer and interpret the 2022 Plan. Our board of directors has initially designated the compensation committee to administer the
2022 Plan. Except when limited by the terms of the 2022 Plan, the compensation committee has the authority to, among other things: select
the persons to be granted awards; determine the type, size and term of awards; establish performance objectives and conditions for earning
awards; determine whether such performance objectives and conditions have been met; and accelerate the vesting or exercisability of an
award. In its discretion, the compensation committee may delegate all or part of its authority and duties with respect to granting awards
to one or more of our officers, subject to certain limitations and provided applicable law so permits.
Our board of directors may amend, alter or discontinue
the 2022 Plan and the compensation committee is able to amend any outstanding award at any time; provided, however, that no such amendment
or termination may adversely affect awards then outstanding without the holder’s permission. In addition, any amendments seeking
to increase the total number of shares reserved for issuance under the 2022 Plan or modifying the classes of participants eligible to
receive awards under the 2022 Plan requires ratification by our stockholders in accordance with applicable law. Additionally, as described
more fully below, neither the compensation committee nor the board of directors is permitted to reprice outstanding options or stock appreciation
rights without shareholder consent.
Eligibility
Any of our employees, directors, and consultants,
or those of our affiliates, are eligible to participate in the 2022 Plan and may be selected by the compensation committee to receive
an award.
Vesting
The compensation committee determines the vesting
conditions for awards. These conditions may include the continued employment or service of the participant, the attainment of specific
individual or corporate performance goals, or other factors as determined in the compensation committee’s discretion (collectively,
“Vesting Conditions”).
Shares of Stock Available for Issuance
Subject to certain adjustments, as of the date
of this prospectus, the maximum number of shares of Common Stock that may be issued under the 2022 Plan in connection with awards is 1,860,000
shares, consisting of (i) the 685,000 shares of Common Stock reserved and available for issuance pursuant to the grant of new awards under
the 2022 Plan, and (ii) the 1,175,000 shares subject to outstanding stock options or other awards granted under our Initial Plan or the
2022 Plan that terminate or expire prior to exercise or settlement; are not issued because the award is settled in cash; are forfeited
because of the failure to vest; or are reacquired or withheld (or not issued) to satisfy a tax withholding obligation or the purchase
or exercise price, if any, as such shares become available from time to time. In addition, the maximum number of shares of Common Stock
that may be issued under the 2022 Plan will automatically increase on January 1 of each calendar year for a period of ten years commencing
on January 1, 2024 and ending on (and including) January 1, 2033, to a number of shares of Common Stock equal to 20% of the total number
of shares of Common Stock outstanding on December 31 of the preceding calendar year; provided, however that the board of directors, or
the compensation committee, may act prior to January 1 of a given calendar year to provide that the increase for such year will be a lesser
number of shares of Common Stock. All available shares may be utilized toward the grant of any type of award under the 2022 Plan. The
2022 Plan imposes a $100,000 limitation on the total grant date fair value with respect to which incentive stock options are exercisable
for the first time by an individual optionee during any single calendar year.
In the event of any merger, consolidation, sale
or disposition of all or substantially all our assets, sale or disposition of at least 50% of our outstanding securities, or other similar
corporate transaction that affects our Common Stock, the board of directors or compensation committee shall make adjustments to the number
and kind of shares authorized by the 2022 Plan and covered under outstanding 2022 Plan awards as it determines appropriate and equitable.
Shares subject to 2022 Plan awards that expire
without being fully exercised or that are otherwise forfeited, cancelled or terminated may again be made available for issuance under
the 2022 Plan. In addition, shares withheld in settlement of a tax withholding obligation, or in satisfaction of the exercise price payable
upon exercise of an option, will again become available for issuance under the 2022 Plan.
Types of Awards
The following types of awards may be granted to
participants under the 2022 Plan: (i) incentive stock options, or ISOs; (ii) nonqualified stock options, or NQOs and together with ISOs,
options, (iii) stock appreciation rights, (iv) restricted stock, or (v) restricted stock units.
Stock Options. An option entitles the holder
to purchase from us a stated number of shares of Common Stock. An ISO may only be granted to an employee of ours or our eligible affiliates.
The compensation committee will specify the number of shares of Common Stock subject to each option and the exercise price for such option,
provided that the exercise price may not be less than the fair market value of a share of Common Stock on the date the option is granted.
Notwithstanding the foregoing, if ISOs are granted to any 10% stockholder, the exercise price shall not be less than 110% of the fair
market value of Common Stock on the date the option is granted.
Generally, options may be exercised in whole or
in part through a cash payment. The compensation committee may, in its sole discretion, permit payment of the exercise price of an option
pursuant to a “cashless exercise,” in the form of previously owned shares of Common Stock based on the fair market value of
the shares on the date the option is exercised, or through means of “net settlement,” which involves the cancellation of a
portion of the option to cover the cost of exercising the balance of the option or by such other means as it deems acceptable.
All options shall be or become exercisable in
accordance with the terms of the applicable award agreement. The maximum term of an option shall be determined by the compensation committee
on the date of grant but shall not exceed 10 years (5 years in the case of ISOs granted to any 10% stockholder). In the case of ISOs,
the aggregate fair market value (determined as of the date of grant) of Common Stock with respect to which such ISOs become exercisable
for the first time during any calendar year cannot exceed $100,000. ISOs granted in excess of this limitation will be treated as non-qualified
stock options.
Stock Appreciation Rights. A stock appreciation
right represents the right to receive, upon exercise, any appreciation in a share of Common Stock over a particular time period. The base
price of a stock appreciation right shall not be less than the fair market value of a share of Common Stock on the date the stock appreciation
right is granted. This award is intended to mirror the benefit the participant would have received if the compensation committee had granted
the participant an option. The maximum term of a stock appreciation right shall be determined by the compensation committee on the date
of grant but shall not exceed 10 years. Distributions with respect to stock appreciation rights may be made in cash, shares of Common
Stock, or a combination of both, at the board of director’s discretion.
Unless otherwise provided in an award agreement
or determined by the compensation committee, if a participant terminates employment with us (or our affiliates) for any reason other than
cause, the participant may exercise his or her unexercised options and stock appreciation rights, to the extent they were exercisable
on the termination date, within the following period of time, provided however that in no event may any award be exercised after termination
of its maximum term: (i) three months following the date of such termination if such termination is a termination without cause (other
than any termination due to the participant’s disability or death); (ii) 12 months following the date of such termination if such
termination is due to the participant’s disability; (iii) 18 months following the date of such termination if such termination is
due to the participant’s death; or (iv) 18 months following the date of the participant’s death if such death occurs following
the date of such termination but during the period such Award is otherwise exercisable. If the participant terminates employment with
us (or our affiliates) for cause, all unexercised options and stock appreciation rights (whether vested or unvested) shall terminate and
be forfeited on the termination date. Unless otherwise provided by the compensation committee, any options and stock appreciation rights
that are not exercisable at the time of termination of employment shall terminate and be forfeited on the termination date.
Restricted Stock. A restricted stock award
is a grant of shares of Common Stock, which are subject to forfeiture restrictions during a restriction period. The compensation committee
will determine the price, if any, to be paid by the participant for each share of Common Stock subject to a restricted stock award. The
restricted stock may be subject to Vesting Conditions. If the specified Vesting Conditions are not attained, the participant will forfeit
the portion of the restricted stock award with respect to which those conditions are not attained, and the underlying Common Stock will
be forfeited to us. At the end of the restriction period, if the Vesting Conditions have been satisfied, the restrictions imposed will
lapse with respect to the applicable number of shares. Unless otherwise provided in an award agreement or determined by the compensation
committee, upon termination a participant will forfeit all restricted stock that then remains subject to forfeiture restrictions.
Restricted Stock Units. Restricted stock
units are granted in reference to a specified number of shares of Common Stock and entitle the holder to receive, on the achievement of
applicable Vesting Conditions, shares of Common Stock. Unless otherwise provided in an award agreement or determined by the compensation
committee, upon termination a participant will forfeit all restricted stock units that then remain subject to forfeiture.
Change of Control
In the event of a change of control, unless otherwise
provided in a grant agreement, employment agreement or other agreement between the Company and the participant, and unless otherwise determined
by an affirmative vote of a majority of the board of directors prior to the occurrence of such change of control: (i) the vesting and
settlement of all outstanding awards to non-employee directors will be automatically accelerated and the shares immediately issued to
the participant (or the Board may direct the payment of a cash settlement equal to the fair market value of the shares that would otherwise
be issued to the participant); (ii) the settlement of vested awards to employees and consultants will automatically be accelerated and
the shares immediately issued to the participant; and (iii) unvested awards to employees and consultants shall be terminated and forfeited
unless the acquiring entity assumes, continues or substitutes any such awards. Notwithstanding the foregoing, to the extent permitted
and in compliance with the requirements of Section 409A of the Code, the Board may in its discretion determine to elect to accelerate
the vesting and settlement of the unvested awards to employees and consultants upon a Change of Control, or direct the payment of a cash
settlement equal to the fair market value of the shares that would otherwise be issued to the participant).
Repricing
Neither our board of directors nor the compensation
committee may reduce the exercise price in effect for outstanding options under the 2022 Plan without obtaining the consent of any participant
whose award would be materially impaired by such action.
Miscellaneous
Generally, awards granted under the 2022 Plan
shall be nontransferable except by will or by the laws of descent and distribution. No participant shall have any rights as a stockholder
with respect to shares covered by options or restricted stock units, unless and until such awards are settled in shares of Common Stock.
Our obligation to issue shares or to otherwise make payments in respect of 2022 Plan awards will be conditioned on our ability to do so
in compliance with all applicable laws and exchange listing requirements. The awards will be subject to our recoupment and stock ownership
policies, as may be in effect from time to time. The 2022 Plan expires 10 years after it becomes effective.
Equity Compensation
Plan Information
The following table presents
information as of December 31, 2022 with respect to shares of our Common Stock that may be issued under our existing equity compensation
plans, which as of December 31, 2022 was only the Initial Plan.
Plan Category | |
Number
of Securities to be Issued upon Exercise of
Outstanding Equity Compensation Plan Options | | |
Weighted- Average Exercise Price of Outstanding Equity Compensation Plan Options | | |
Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (excluding securities reflected in the first column) | |
Equity compensation plans approved by security holders | |
| 1,100,000 | | |
$ | 0.84 | | |
| 810,000 | |
Equity compensation plans not approved by security holders | |
| -- | | |
| -- | | |
| -- | |
Total | |
| 1,100,000 | | |
$ | 0.84 | | |
| 810,000 | |
DIRECTOR COMPENSATION
The following table shows certain information
with respect to the compensation of all of our non-employee directors for the fiscal year ended December 31, 2022, all of whom were
director nominees at the time of grant, in anticipation of director services to be provided:
Name | |
Fees Earned or Paid in Cash ($) | | |
Stock Awards ($)(1) | | |
Option Awards ($)(1) | | |
Total ($) | |
John R. Murphy | |
$ | — | | |
$ | 187,500 | (2) | |
$ | 37,500 | (3) | |
$ | 225,000 | |
Steven Zelenkofske, D.O. | |
$ | — | | |
$ | 100,000 | (4) | |
$ | 18,750 | (4) | |
$ | 118,750 | |
Glynn Wilson, Ph.D. | |
$ | — | | |
$ | — | | |
$ | 149,650 | (5) | |
$ | 149,650 | |
(1) | In
accordance with SEC rules, this column reflects the aggregate fair value of the stock and option awards granted as of their respective
grant dates in accordance with Financial Accounting Standard Board Accounting Standards Codification Topic 718 for stock-based compensation
transactions (ASC 718). The valuation assumptions used in determining such amounts are described in Note 1 and Note 10 to our audited
financial statements included elsewhere in this prospectus. These amounts do not correspond to the actual value that may be realized
by the Directors upon vesting or exercise of such awards. |
(2) | Represents
50,000 shares of Common Stock issued to John Murphy on September 16, 2022. |
(3) | Represents
100,000 stock options issued to John Murphy on July 11, 2022, which options have an at an exercise price of $0.64 per common share and
will vest over a period of three (3) years, with 33.33% vesting on the first anniversary of the effective date and thereafter 1/36 on
a monthly basis. |
(4) | Represents
40,000 shares of Common Stock issued to Steven Zelenkofske, D.O. on August 18, 2022. |
(5) | Represents
50,000 stock options issued to Steven Zelenkofske, D.O. on July 11, 2022, which options have an at an exercise price of $0.64 per common
share and will vest over a period of three (3) years, with 33.33% vesting on the first anniversary of the effective date and thereafter
1/36 on a monthly basis. |
(6) | Represents
50,000 stock options issued to Glynn Wilson, Ph.D. on October 3, 2022, which options have an at an exercise price of $5.00 per common
share and will vest over a period of three (3) years, with 33.33% vesting on the first anniversary of the effective date and thereafter
1/36 on a monthly basis. |
For the fiscal year ended December 31, 2023, our directors will each
receive annual cash compensation in the amount of $35,000 and the Chair of the Audit Committee will receive additional annual cash compensation
of $15,000 per year. From time to time, we may grant additional stock options to certain of our non-employee directors as compensation
for their services as directors. In addition to the annual cash compensation of $35,000, for his services as a director Mr. Lisicki was
issued options to purchase 75,000 shares of common stock vesting 1/3 on August 1, 2024 and thereafter monthly pro rata over 24 months.
The table below shows the aggregate number of
option awards outstanding at fiscal year-end of our non-employee directors.
Name | |
Number of Shares Subject to Outstanding Options as of December 31, 2022 | |
John R. Murphy | |
| 100,000 | |
Steven Zelenkofske, D.O. | |
| 50,000 | |
Glynn Wilson, Ph.D. | |
| 50,000 | |
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Each of the related party transactions described
below was negotiated on an arm’s length basis. We believe that the terms of such agreements are as favorable as those we could have
obtained from parties not related to us. The following are summaries of certain provisions of our related party agreements and are qualified
in their entirety by reference to all of the provisions of such agreements. Because these descriptions are only summaries of the applicable
agreements, they do not necessarily contain all of the information that you may find useful. We therefore urge you to review the agreements
in their entirety. Copies of the forms of the agreements have been filed as exhibits to the Registration Statement and are available electronically
on the website of the SEC at www.sec.gov.
In addition to the compensation arrangements,
including employment, termination of employment and change in control arrangements, with our directors and executive officers, including
those discussed in the sections titled “Management” and “Executive Compensation,” the following is a description
of each transaction since January 25, 2022 or any currently proposed transaction in which:
|
● |
we have been or are to be a party to; |
|
● |
the amount involved exceeded or exceeds $120,000 or 1% of the average of our total assets as of the end of the last two completed fiscal years; and |
|
● |
any of our directors, executive officers or holders of more than 5% of our outstanding capital stock, or any immediate family member of, or person sharing the household with, any of these individuals or entities, had or will have a direct or indirect material interest. |
For information on our compensation arrangements,
including employment, termination of employment and change in control arrangements, with our directors and executive officers, see the
sections titled “Management” and “Executive Compensation.”
On January 25, 2022, we entered into an agreement
with Phamace, LLC, a consulting firm of which Quang Pham, our Chief Executive Officer, is the sole member, for an initial term of January
25, 2022 through February 28, 2022 to provide advisory and administrative services relating to preparing the Company to launch as an operating
company. Pursuant to the agreement, the Company shall pay the sum of $115,000 to Phamace, LLC for services rendered, which was paid in
January 2023.
On January 25, 2022, we issued 7,500,000 shares
of Common Stock, pursuant to a subscription agreement, to Quang Pham, our Chief Executive Officer. Mr. Pham paid a total of $7,500 for
such founders shares.
On March 1, 2022, we issued a convertible promissory
note in the amount of $500,000 to John Murphy, a director, which bears interest at 5% and matures on March 1, 2025. The note, as amended
in December 2022, converted into 514,792 shares of Common Stock at a conversion price equal to $1.00 upon consummation of the initial
public offering.
On May 17, 2022, we issued 450,000 shares of restricted
Common Stock, pursuant to a restricted stock purchase agreement, to Matthew Szot, our Chief Financial Officer, which shares shall vest
quarterly over a period of two (2) years, subject to certain adjustments, as provided in the Restricted Stock Purchase Agreement dated
May 17, 2022.
On July 11, 2022, we issued stock options to purchase
an aggregate of 150,000 shares of Common Stock to two (2) directors. The options have an exercise price of $0.64 per common share and
will vest over a period of three (3) years, with 33.33% vesting on the first anniversary of the effective date, and thereafter 1/36 on
a monthly basis.
On August 18, 2022, we issued stock options to
purchase 300,000 shares of Common Stock to Douglas Losordo, our Chief Medical Officer. The options have an exercise price of $0.64 per
common share and will vest quarterly over a period of three (3) years, subject to certain adjustments.
On August 18, 2022, we issued 40,000 shares of
Common Stock to Steven Zelenkofske, a director.
On August 22, 2022, we issued a convertible promissory
note in the amount of $50,000 to Glynn Wilson, a director, which bears interest at 6% and matures on September 13, 2025. The note was
converted into 50,000 shares of Common Stock at a conversion price equal to $1.00 upon consummation of the initial public offering.
On September 16, 2022, we issued 50,000 shares
of Common Stock to John Murphy, a director.
On October 3, 2022, we issued stock options to
purchase 50,000 shares of Common Stock to Glynn Wilson, a director. The options have an exercise price of $5.00 per common share and will
vest over a three-year period, with 33.33% vesting on the first anniversary of the effective date, and thereafter 1/36 on a monthly basis.
On January 19, 2023,
we issued 600,000 shares of Common Stock to HESP LLC, pursuant to the terms an Amendment to the Asset Purchase Agreement, dated as of
August 18, 2022, between the Company and HESP LLC.
On January 24, 2023, we issued 50,000 shares of
Common Stock to Matthew Szot, our Chief Financial Officer.
On July 23, 2023, we issued stock options to purchase
75,000 shares of Common Stock to a director. The options have an exercise price of $1.20 per common share and will vest over a period
of three (3) years, with 33.33% vesting on August 1, 2024, and thereafter 1/36 on a monthly basis.
Indemnification Agreements
We have entered into separate indemnification
agreements with each of our current executive officers and intend to enter into separate indemnification agreements with each of our directors
and executive officers, in addition to the indemnification that will be provided for in our amended and restated bylaws. The indemnification
agreements and our amended restated bylaws require us to indemnify our directors and executive officers to the fullest extent permitted
by Delaware law. See the section titled “Description of Securities — Limitations on Liability and Indemnification of Officers
and Directors” for additional information.
Our Policy Regarding Related Party Transactions
Our board of directors recognizes the fact that
transactions with related persons present a heightened risk of conflicts of interest and/or improper valuation (or the perception thereof).
Our board of directors adopted a written policy on transactions with related persons that is in conformity with the requirements for issuers
having publicly held Common Stock that is listed on the Nasdaq Stock Market. Under the new policy:
|
● |
any related person transaction, and any material amendment or modification to a related person transaction, must be reviewed and approved or ratified by the Audit Committee; and |
|
● |
any employment relationship or transaction involving an executive officer and any related compensation must be approved by the compensation committee of the board of directors or recommended by the compensation committee to the board of directors for its approval. |
In connection with the review and approval or
ratification of a related person transaction:
|
● |
management must disclose to the committee or disinterested directors, as applicable, the name of the related person and the basis on which the person is a related person, the material terms of the related person transaction, including the approximate dollar value of the amount involved in the transaction, and all the material facts as to the related person’s direct or indirect interest in, or relationship to, the related person transaction; |
|
● |
management must advise the committee or disinterested directors, as applicable, as to whether the related person transaction complies with the terms of our agreements governing our material outstanding indebtedness that limit or restrict our ability to enter into a related person transaction; |
|
● |
management must advise the committee or disinterested directors, as applicable, as to whether the related person transaction will be required to be disclosed in our applicable filings under the Securities Act or the Exchange Act, and related rules, and, to the extent required to be disclosed, management must ensure that the related person transaction is disclosed in accordance with the Securities Act and the Exchange Act and related rules; and |
|
● |
management must advise the committee or disinterested directors, as applicable, as to whether the related person transaction constitutes a “personal loan” for purposes of Section 402 of the Sarbanes-Oxley Act. |
In addition, the related person transaction policy
provides that the committee or disinterested directors, as applicable, in connection with any approval or ratification of a related person
transaction involving a non-employee director, should consider whether such transaction would compromise the director’s status as
an “independent,” “outside,” or “non-employee” director, as applicable, under the rules and regulations
of the SEC, the Nasdaq Stock Market, and the Code.
DESCRIPTION OF SECURITIES
The following description of our securities
and the provisions of our amended and restated certificate of incorporation and our amended and restated bylaws are summaries and are
qualified by reference to the amended and restated certificate of incorporation and the amended and restated bylaws. We have filed copies
of these documents with the SEC as exhibits to our registration statement of which this prospectus forms a part.
General
On December 5, 2022, we filed an amended
and restated certificate of incorporation with the Secretary of State of the State of Delaware, pursuant to which our authorized capital
stock consists of:
| ● | 75,000,000 shares of Common Stock, par value $0.001 per
share; and |
| ● | 7,500,000 shares of preferred stock, par value $0.001
per share. |
We are selling shares of Common Stock in this
offering based on an assumed initial public offering price of $5.00 per share. All of our Common Stock outstanding upon consummation of
this offering will be fully paid and non-assessable.
The following description of our capital stock
and provisions of our amended and restated certificate of incorporation and amended and restated bylaws, both of which became effective
on December 5, 2022, are summaries of material terms and provisions and are qualified by reference to our amended and restated certificate
of incorporation and amended and restated bylaws, copies of which have been filed with the SEC as exhibits to the registration statement
of which this prospectus is a part. The descriptions of our Common Stock and preferred stock reflect the content of the amended and restated
certificate of incorporation and amended and restated bylaws.
Certain provisions of our amended and restated
certificate of incorporation and our amended and restated bylaws summarized below, and under Delaware law, may be deemed to have an anti-takeover effect
and may delay or prevent a tender offer or takeover attempt that a stockholder might consider in its best interest, including those attempts
that might result in a premium over the market price for the shares of Common Stock.
Common Stock
We are authorized to issue one class of Common
Stock. Holders of our Common Stock are entitled to one vote for each share of Common Stock held of record for the election of our directors
and all other matters requiring stockholder action, except with respect to amendments to our certificate of incorporation that alter or
change the powers, preferences, rights or other terms of any outstanding preferred stock if the holders of such affected series of preferred
stock are entitled to vote on such an amendment. Our directors are elected by a plurality of the votes cast by the stockholders entitled
to vote at our annual meeting of stockholders, and are not entitled to cumulative voting rights. Holders of Common Stock are entitled
to receive such dividends, if any, as may be declared from time to time by our Board of Directors in its discretion out of funds legally
available therefor. The payment of dividends, if any, on shares of our Common Stock are subject to the prior payment of dividends on any
outstanding preferred stock, of which there is none. Upon our liquidation or dissolution, the holders of our Common Stock are entitled
to receive a pro rata portion of all assets remaining available for distribution to stockholders after payment of all liabilities and
provision for the liquidation of any shares of preferred stock outstanding at that time. The holders of our Common Stock have no preemptive,
subscription or redemption rights, and have no rights to convert their Common Stock into any other securities. The absence of preemptive
rights could result in a dilution of the interest of the existing stockholders should additional shares of our Common Stock be issued.
In addition, the rights of holders of our Common Stock are subject to, and may be adversely affected by, the rights of holders of shares
of any series of preferred stock that we may designate and issue in the future.
Preferred Stock
No shares of preferred stock are outstanding as
of the date of this offering. Our Board of Directors is authorized, without action by our stockholders, to designate and issue up to 7,500,000 shares
of preferred stock in one or more series. Our Board of Directors has the right to fix the voting rights, if any, designations, powers,
preferences, the relative, participating, optional or other special rights, if any, and any qualifications, limitations and restrictions
thereof, applicable to the shares of each series of designated preferred stock. Our Board of Directors is able to, without stockholder
approval, issue shares of preferred stock with voting and other rights that could adversely affect the voting power and other rights of
the holders of our Common Stock and could have anti-takeover effects. The ability of our Board of Directors to issue preferred stock
without stockholder approval could have the effect of delaying, deferring or preventing a change of control of us or the removal of existing
management. Although we do not currently intend to issue any shares of preferred stock, we cannot assure you that we will not do so in
the future.
Warrants
Placement Agent Warrants
On July 14, 2022, August 22, 2022, and September
13, 2022, we issued to Boustead Securities, LLC, as placement agent, five-year warrants, as amended, to purchase an aggregate of
up to 11,500 shares of our Common Stock at an exercise price equal to 60% of the initial public offering price per share.
On November 30, 2022, we issued to Boustead Securities,
LLC, as placement agent, a five-year warrant to purchase up to 15,000 shares of our Common Stock at an exercise price of $1.00 per share.
Representative’s Warrants
In connection with our initial public offering,
on January 19, 2023, we issued to Boustead Securities, LLC, as representative of the underwriters, warrants (the “Representative’s
Warrants”) to purchase up to 84,000 shares of our Common Stock as a portion of the underwriting compensation payable to the
underwriters in connection with our initial public offering. The Representative’s Warrants are exercisable at $6.00 per share for
five years; however such warrants may not be sold, transferred, assigned, pledged or hypothecated until July 18, 2023 (180 days following
the commencement of sales in the initial public offering). The warrants are not redeemable by us.
Warrants Issued in the Private Placement
See “Description of the Transaction”
for a description of the Common Warrants, Pre-Funded Warrants and Placement Agent Warrants issued in the Private Placement.
Registration Rights
The Representative’s Warrants provide for
a one-time demand registration of the shares of Common Stock underlying the Representative’s Warrants (the “Representative’s
Warrant Shares”) until January 19, 2028, as well as immediate “piggyback” registration rights with respect to the Representative’s
Warrant Shares until January 19, 2026.
For a description of the registration rights pursuant
to the Registration Rights Agreement entered into with the Investor Selling Stockholder see “Description of the Transaction-Registration
Rights Agreement.”
Stock Options
As of the date of this prospectus, the maximum
number of shares of Common Stock that may be issued under the 2022 Plan in connection with awards is 1,860,000 shares, consisting of (i)
the 685,000 shares of Common Stock reserved and available for issuance pursuant to the grant of new awards under the 2022 Plan, and (ii)
the 1,175,000 shares subject to outstanding stock options granted under our Initial Plan or the 2022 Plan that terminate or expire prior
to exercise or settlement; are not issued because the award is settled in cash; are forfeited because of the failure to vest; or are reacquired
or withheld (or not issued) to satisfy a tax withholding obligation or the purchase or exercise price, if any, as such shares become available
from time to time.
Forum Selection
Our amended and restated certificate of incorporation
and amended and restated bylaws provide that unless we consent in writing to the selection of an alternative forum, the Court of Chancery
of the State of Delaware (or, in the event that the Court of Chancery does not have jurisdiction, the federal district court for the District
of Delaware or other state courts of the State of Delaware) is the exclusive forum for (i) any derivative action or proceeding brought
on our behalf; (ii) any action asserting a claim of breach of fiduciary duty owed by any director, officer, employee or agent of
the Company to the Company or our stockholders; (iii) any action asserting a claim arising pursuant to the provisions of the Delaware
General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws; or (iv) any action
asserting a claim against us that is governed by the internal affairs doctrine of the State of Delaware; provided that, if and only if
the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, or the Company consents
in writing to the selection of an alternative forum, such action may be brought in another state or federal court sitting in the State
of Delaware. Our amended and restated certificate of incorporation and amended and restated bylaws also provide that the federal district
courts of the United States of America is the exclusive forum for the resolution of any complaint asserting a cause of action against
under the Securities Act. Notwithstanding the foregoing, the exclusive forum provision does not apply to suits brought to enforce any
liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. Nothing in
our amended and restated certificate of incorporation or amended and restated bylaws preclude stockholders that assert claims under the
Exchange Act from bringing such claims in state or federal court, subject to applicable law.
Anti-Takeover Provisions
Our amended and restated certificate of incorporation
and amended and restated bylaws contain provisions that may delay, defer, or discourage another party from acquiring control of us. We
expect that these provisions, which are summarized below, will discourage coercive takeover practices or inadequate takeover bids. These
provisions are also designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors, which
we believe may result in an improvement of the terms of any such acquisition in favor of our stockholders. However, they also give our
board of directors the power to discourage acquisitions that some stockholders may favor.
Section 203 of the Delaware General
Corporation Law
We are subject to Section 203 of the Delaware
General Corporation Law. Subject to certain exceptions, Section 203 prevents a publicly held Delaware corporation from engaging in
a “business combination” with any “interested stockholder” for three years following the date that the person
became an interested stockholder, unless the interested stockholder attained such status with the approval of our board of directors or
unless the business combination is approved in a prescribed manner. A “business combination” includes, among other things,
a merger or consolidation involving us and the “interested stockholder” and the sale of more than 10% of our assets. In general,
an “interested stockholder” is any entity or person beneficially owning 15% or more of our outstanding voting stock and any
entity or person affiliated with or controlling or controlled by such entity or person.
Classified Board of Directors
Our board of directors is divided into three classes
serving three-year terms, with one class being elected each year by a plurality of the votes cast by the stockholders entitled to vote
on the election.
Proposals of Business and Nominations
Our amended and restated bylaws generally regulates
proposals of business and nominations for election of directors by stockholders. In general, Section 5 requires stockholders intending
to submit proposals or nominations at a stockholders’ meeting to provide the Company with advance notice thereof, including information
regarding the stockholder proposing the business or nomination as well as information regarding the proposed business or nominee. Section
5 also provides a time period during which business or nominations must be provided to the Company that creates a predictable window for
the submission of such notices, eliminating the risk that the Company finds a meeting will be contested after printing its proxy materials
for an uncontested election and providing the Company with a reasonable opportunity to respond to nominations and proposals by stockholders.
Blank Check Preferred Stock
Our board of directors has the right to issue
preferred stock in one or more series and to determine the designations, rights, preferences of such preferred stock without stockholder
approval.
Board Vacancies
Our amended and restated bylaws generally provide
that only our board of directors (and not the stockholders) may fill vacancies and newly created directorships.
Stockholder Action by Written Consent
Our amended and restated certificate of incorporation
and our amended and restated bylaws provide that any action required or permitted to be taken by our stockholders at an annual meeting
or special meeting of stockholders may only be taken if it is properly brought before such meeting.
Special Meetings of Stockholders
Our amended and restated certificate of incorporation
and amended and restated bylaws also provide that, except as otherwise required by law, special meetings of the stockholders may only
be called by our board of directors, Chairman of the board of directors, or our Chief Executive Officer.
Amendment of Certificate of Incorporation
or Bylaws
The Delaware General Corporation Law provides
generally that the affirmative vote of a majority of the shares entitled to vote on any matter is required to amend a corporation’s
certificate of incorporation or bylaws, unless a corporation’s certificate of incorporation or bylaws, as the case may be, requires
a greater percentage. Our bylaws may be amended or repealed by a majority vote of our board of directors or by the affirmative vote of
the holders of at least 66 2/3% of the votes which all our stockholders would be eligible to cast in an election of directors.
Limitations on Liability and Indemnification
of Officers and Directors
Our amended and restated bylaws provide indemnification
for our directors and executive officers to the fullest extent permitted by the Delaware General Corporation Law. The indemnification
agreements that we have entered into with each of our current executive officers and that we intend to enter into with each of our directors
and executive officers may, in some cases, be broader than the specific indemnification provisions contained under Delaware law. In addition,
as permitted by Delaware law, our amended and restated certificate of incorporation includes provisions that eliminate the personal liability
of our directors and officers for monetary damages resulting from breaches of certain fiduciary duties as a director or officer, as applicable,
except to the extent such an exemption from liability thereof is not permitted under the Delaware General Corporation Law. The effect
of these provisions is to restrict our rights and the rights of our stockholders in derivative suits to recover monetary damages against
a director or officer for breach of fiduciary duties as a director or officer, subject to certain exceptions in which case the director
or officer would be personally liable. An officer may not be exculpated for any action brought by or in the right of the corporation.
A director may not be exculpated for improper distributions to stockholders. Further, pursuant to Delaware law a director or officer may
not be exculpated for:
|
● |
any breach of his or her duty of loyalty to us or our stockholders; |
|
● |
acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law; and |
|
● |
any transaction from which the director or officer derived an improper personal benefit. |
These limitations of liability do not apply to
liabilities arising under the federal or state securities laws and do not affect the availability of equitable remedies such as injunctive
relief or rescission.
Our amended and restated bylaws provide that we
will indemnify our directors and executive officers to the fullest extent permitted by law, and may indemnify other officers, employees
and other agents. Our amended and restated bylaws also provide that we are obligated to advance expenses incurred by a director or executive
officer in advance of the final disposition of any action or proceeding.
We have entered into separate indemnification
agreements with each of our current executive officers and plan to enter into separate indemnification agreements with our directors and
executive officers. These agreements, among other things, require us to indemnify our directors and officers for any and all expenses
(including reasonable attorneys’ fees, retainers, court costs, transcript costs, fees of experts, witness fees, travel expenses,
duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees) judgments, fines and amounts paid in
settlement actually and reasonably incurred by such directors or officers or on his or her behalf in connection with any action or proceeding
arising out of their services as one of our directors or officers, or any of our subsidiaries or any other company or enterprise to which
the person provides services at our request provided that such person follows the procedures for determining entitlement to indemnification
and advancement of expenses set forth in the indemnification agreement. We believe that these bylaw provisions and indemnification agreements
are necessary to attract and retain qualified persons as directors and officers.
The limitation of liability and indemnification
provisions in our amended and restated certificate of incorporation and amended and restated bylaws may discourage stockholders from bringing
a lawsuit against directors for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigation against
directors and officers, even though an action, if successful, might provide a benefit to us and our stockholders. Our results of operations
and financial condition may be harmed to the extent we pay the costs of settlement and damage awards against directors and officers pursuant
to these indemnification provisions.
Insofar as indemnification for liabilities arising
under the Securities Act may be permitted to directors, officers or persons controlling us, we have been informed that, in the opinion
of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
At present, there is no pending litigation or
proceeding involving any of our directors or officers as to which indemnification is required or permitted, and we are not aware of any
threatened litigation or proceeding that may result in a claim for indemnification.
Dissenters’ Rights of Appraisal and Payment
Under the Delaware General Corporation Law, with
certain exceptions, our stockholders will have appraisal rights in connection with a merger or consolidation of Cadrenal Therapeutics,
Inc. Pursuant to the Delaware General Corporation Law, stockholders who properly request and perfect appraisal rights in connection with
such merger or consolidation will have the right to receive payment of the fair value of their shares as determined by the Delaware Court
of Chancery.
Stockholders’ Derivative Actions
Under the Delaware General Corporation Law, any
of our stockholders may bring an action in our name to procure a judgment in our favor, also known as a derivative action, provided that
the stockholder bringing the action is a holder of our shares at the time of the transaction to which the action relates or such stockholder’s
stock thereafter devolved by operation of law.
Transfer Agent and Registrar
The transfer agent and registrar for our Common
Stock is Transfer Online, Inc., 512 SE Salmon Street, Portland, Oregon 97214.
Trading Symbol and Market
Our Common Stock is listed on the Nasdaq Capital
Market under the symbol “CVKD.”
DESCRIPTION OF THE TRANSACTION
On July 12, 2023, we entered into the Purchase
Agreement with the Investor Selling Stockholder pursuant to which the Company agreed to issue and sell to the Investor Selling Stockholder
in the Private Placement priced at-the-market consistent with the rules of the Nasdaq Stock Market LLC, an aggregate of 8,751,430 shares
(the “Shares”) of Common Stock consisting of: (i) 1,300,000 shares of Common Stock, (ii) in lieu of additional Shares, Pre-Funded
Warrants to purchase up to an aggregate of 2,985,715 shares of Common Stock, and (iii) accompanying Common Warrants to purchase up to
an aggregate of 4,285,715 shares of Common Stock. The combined purchase price of each Share and accompanying Common Warrants was $1.75.
The combined purchase price of each Pre-Funded Warrant and accompanying Common Warrants was $1.7499, which is equal to the Investor Selling
Stockholder’s combined purchase price per Share and accompanying Common Warrants, minus the per share exercise price of each Pre-Funded
Warrant of $0.0001.
The Private Placement closed on July 14, 2023.
We received aggregate gross proceeds from the Private Placement of approximately $7.5 million, before deducting the placement agent commissions
and estimated offering expenses payable by us. We intend to use the net proceeds from the Private Placement for working capital purposes.
Each Pre-Funded Warrant has
an exercise price equal to $0.0001 per share. The Pre-Funded Warrants are exercisable at any time after their original issuance and will
not expire until exercised in full. Each Common Warrant will have an exercise price equal to $1.75 per share. The Common Warrants are
exercisable at any time after their original issuance and will expire on the five and one-half (5.5) year anniversary of their issuance.
The exercise price and number of shares of Common Stock issuable upon exercise of the Common Warrant and pre-Funded Warrant are subject
to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events.
The Pre-Funded Warrants and the Common Warrants
issued in the Private Placement provide that a holder of Pre-Funded Warrants or Common Warrants, as applicable, will not have the right
to exercise any portion of its Pre-Funded Warrants or Warrants if such holder, together with its affiliates, and any other party whose
holdings would be aggregated with those of the holder for purposes of Section 13(d) or Section 16 of the Exchange Act would beneficially
own in excess of 9.99% for the Pre-Funded Warrants and 4.99% for the Common Warrants of the number of shares of Common Stock outstanding
immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however, that
the holder may increase or decrease the Beneficial Ownership Limitation by giving notice to the Company, with any such increase not taking
effect until the sixty-first day after such notice is delivered to the Company but not to any percentage in excess of 9.99%. The Common
Warrants may be exercised on a cashless basis if a registration statement registering the shares of Common Stock underlying the Common
Warrants is not effective. The Pre-Funded Warrants may be exercised on a cashless basis.
Subject to applicable laws, a Common Warrant and
Pre-Funded Warrant may be transferred at the option of the holder upon surrender of the applicable warrant to us together with the appropriate
instruments of transfer.
There is no trading market available for the Common
Warrants or Pre-Funded Warrants on any securities exchange or nationally recognized trading system. We do not intend to list the Common
Warrants or Pre-Funded Warrants on any securities exchange or nationally recognized trading system.
In the event of a fundamental transaction,
as described in the Common Warrants and Pre-Funded Warrants and generally including any reorganization, recapitalization or reclassification
of our Common Stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation
or merger with or into another person, the acquisition of more than 50% of our outstanding Common Stock, or any person or group becoming
the beneficial owner of 50% of the voting power represented by our outstanding Common Stock, the holders of the Common Warrants and Pre-Funded
Warrants will be entitled to receive upon exercise of the Common Warrants and Pre-Funded Warrants the kind and amount of securities, cash
or other property that the holders would have received had they exercised the Common Warrants and Pre-Funded Warrants immediately prior
to such fundamental transaction. In addition, in certain circumstances, upon a fundamental transaction, the holder will have the right
to require us to repurchase its Common Warrants at the Black Scholes value; provided, however, that, if the fundamental transaction is
not within our control, including not approved by our board of directors, then the holder shall only be entitled to receive the same type
or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of the Common Warrant, that
is being offered and paid to the holders of Common Stock in connection with the fundamental transaction.
Pursuant to a letter agreement dated July
12, 2023 (the “Engagement Agreement”), H.C.W. acted as placement agent for the Private Placement. Boustead Securities,
LLC (“Boustead”) served as the financial advisor to the Company. The Company agreed to pay H.C.W. a cash fee of 7.5% of
the aggregate gross proceeds raised in the Private Placement, of which 25% was paid to Boustead, in addition to other advisory fees
paid to Boustead, plus H.C.W. was paid a management fee equal to 1.0% of the gross proceeds raised in the Private Placement and
reimbursement of certain expenses and legal fees. Pursuant to the terms of the Engagement Agreement, the Company issued H.C.W. the
Placement Agent Warrants to purchase an aggregate of 278,571 shares of Common Stock, which is equal to 6.5% of the shares of Common
Stock (and Pre-Funded Warrants, if any) sold in the Private Placement. The Placement Agent Warrants have substantially the same
terms as the Common Warrants, except that the Placement Agent Warrants have an exercise price of $2.1875, which is equal to 125% of
the offering price of the Shares and accompanying Common Warrants sold in the Private Placement and expire on the five and one-half
(5.5) year anniversary of the date of issuance.
The Purchase Agreement prohibits, with certain
limited exceptions, the Company for 60 days following the Effectiveness Deadline (defined below) from issuing any shares of Common Stock
or Common Stock Equivalents (as defined in the Purchase Agreement) or filing any registration statement (other than a registration statement
on Form S-8 and this registration statement).
The Purchase Agreement contains customary representations,
warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, including for liabilities
arising under the Securities Act, other obligations of the parties and termination provisions. The representations, warranties and covenants
contained in the Purchase Agreement were made only for the purposes of such agreements and as of the specific dates, were solely for the
benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties.
Registration Rights Agreement
In connection with the Private Placement, we entered
into a registration rights agreement (the “Registration Rights Agreement”) with the Investor Selling Stockholder, dated July
12, 2023, pursuant to which we agreed to register for resale the Shares and the issuance of the shares of Common Stock underlying the
Common Warrants and Pre-Funded Warrants held by the Investor (the “Registrable Securities”). Under the Registration
Rights Agreement, we agreed to file a registration statement covering the resale of the Shares and issuance of the shares of Common Stock
issuable upon exercise of the Pre-Funded Warrants and Warrants by the Investor Selling Stockholder of the Registrable Securities
within 15 days following the date of the Registration Rights Agreement (the “Filing Deadline”). We agreed to use commercially
reasonable efforts to cause such registration statement to become effective (the “Effectiveness Deadline”) as soon as practicable
(but no later than the 45th calendar day following the date of the Registration Rights Agreement or, in the event the SEC reviews and
has written comments to the registration statement, the 75th calendar day following the date of the Registration Rights Agreement) and
to keep such registration statement effective until the date the Shares and the shares of Common Stock underlying the Common Warrants
and Pre-Funded Warrants covered by such registration statement have been sold or may be resold pursuant to Rule 144 without
restriction. We agreed to be responsible for all fees and expenses incurred in connection with the registration of the Registrable Securities.
In the event (i) the registration statement
has not been filed by the Filing Deadline, including filing the registration statement without affording the Investor the opportunity
to review and common thereon or the Company subsequently withdraws the filing of the registration statement (ii) the Company fails to
file with the SEC a request for acceleration of a registration statement within five (5) trading days of the date that the Company is
notified by the SEC that such Registration Statement will not be “reviewed” or will not be subject to further review, (iii)
prior to the effective date of a registration statement, the Company fails to file a pre-effective amendment and otherwise respond in
writing to comments made by the SEC in respect of such registration statement within twenty (20) calendar days after the receipt of comments
by or notice from the SEC that such amendment is required in order for such registration statement to be declared effective; (iv) the
registration statement has not been declared effective prior to Effectiveness Deadline, or (v) after the registration statement has
been declared effective by the SEC, sales cannot be made pursuant to the registration statement for any reason including by reason of
a stop order or our failure to update such registration statement, subject to certain limited exceptions, then the Company has agreed
to make pro rata payments to the Investor as liquidated damages in an amount equal to 1% of the aggregate amount invested by the Investor
in the Registrable Securities per 30-day period or pro rata for any portion thereof for each such month during which such event
continues, subject to an aggregate maximum cap of 6%.
We have granted the Investor Selling Stockholder
and H.C.W. customary indemnification rights in connection with the registration statement. The Investor Selling Stockholder also granted
to us customary indemnification rights in connection with the registration statement.
Lock-Up Agreement
In connection with the Private Placement, we and
our directors and officers have entered into a lock-up agreement (the “Lock-Up Agreement”) which restricts the sale, pledge
or transfer of the shares of common stock held by such directors and officers for a period of 60 days following the effective date of
the registration statement of which this prospectus is a part.
The foregoing descriptions of the Purchase Agreement,
the Pre-Funded Warrants, the Common Warrants, the Placement Agent Warrants, the Registration Rights Agreement, and the Lock-Up Agreement
do not purport to be complete and are qualified in their entirety by reference to such agreements, copies of which are filed as exhibits
to this registration statement, and incorporated by reference herein.
SELLING STOCKHOLDERS
The Common Stock being offered by the Selling
Stockholders are those previously issued to the Selling Stockholders and those issuable to the Selling Stockholders, upon exercise of
the Common Warrants, Pre-Funded Warrants and Placement Agent Warrants. For additional information regarding the issuances of those Shares,
Common Warrants, Pre-Funded Warrants and Placement Agent Warrants, see “Description of the Transaction” above. We are registering
the shares of Common Stock in order to permit the Selling Stockholders to offer the shares for resale from time to time. Except for the
ownership of the Shares, the Common Warrants, the Pre-Funded Warrants and the Placement Agent Warrants, the Selling Stockholders have
not had any material relationship with us within the past three years provided, however, each
of Michael Vasinkevich, Noam Rubinstein, Craig Schwabe and Charles Worthman are associated persons of H.C.W., which served as our placement
agent in connection with the Private Placement for which H.C.W. received compensation.
The table below lists the Selling Stockholders
and other information regarding the beneficial ownership of the shares of Common Stock by each of the Selling Stockholders. The second
column lists the number of shares of Common Stock beneficially owned by the Selling Stockholders, based on its ownership of the shares
of Common Stock, the Common Warrants, the Pre-Funded Warrants and the Placement Agent Warrants, as of July 20, 2023, assuming exercise
of the Common Warrants, Pre-Funded Warrants and the Placement Agent Warrants held by the Selling Stockholders on that date, without regard
to any limitations on exercises.
The third column lists the shares of Common Stock
being offered by this prospectus by the Selling Stockholders.
In accordance with the terms of the Registration
Rights Agreement with the Investor Selling Stockholder, this prospectus generally covers the resale of the sum of (i) the number of shares
of Common Stock issued to the Selling Stockholders in the Private Placement described above and (ii) the maximum number of shares of Common
Stock issuable upon exercise of the related Common Warrants, Pre-Funded Warrants and the Placement Agent Warrants, determined as if the
outstanding Common Warrants, Pre-Funded Warrants and the Placement Agent Warrants were exercised in full as of the trading day immediately
preceding the date this registration statement was initially filed with the SEC, each as of the trading day immediately preceding the
applicable date of determination and all subject to adjustment as provided in the registration right agreement, without regard to any
limitations on the exercise of the Common Warrants, the Pre-Funded Warrants and the Placement Agent Warrants. The fourth column assumes
the sale of all of the Shares offered by the Selling Stockholders pursuant to this prospectus.
Under the terms of the Common Warrants, Pre-Funded
Warrants and the Placement Agent Warrants, the Selling Stockholders may not exercise the Common Warrants, the Pre-Funded Warrants or the
Placement Agent Warrants to the extent such exercise would cause such Selling Stockholder, together with its affiliates and attribution
parties, to beneficially own a number of shares of Common Stock which would exceed 4.99% or 9.99%, as applicable, of our then outstanding
Common Stock following such exercise, excluding for purposes of such determination shares of Common Stock issuable upon exercise of such
warrants which have not been exercised. The number of shares in the second and fourth columns do not reflect this limitation. The Selling
Stockholders may sell all, some or none of their shares in this offering. See “Plan of Distribution.”
Name of Selling Shareholder | |
Number of shares of Common Stock Owned Prior to Offering | | |
Maximum Number of shares of Common Stock to be Sold Pursuant to this Prospectus | | |
Number of shares of Common Stock Owned After Offering | |
Armistice Capital Master, LLC(1) | |
| 8,571,430 | | |
| 8,571,430 | | |
| — | |
Noam Rubinstein(2) | |
| 87,750 | | |
| 87,750 | | |
| — | |
Craig Schwabe(2) | |
| 9,402 | | |
| 9,402 | | |
| — | |
Michael Vasinkevich(2) | |
| 178,634 | | |
| 178,634 | | |
| — | |
Charles Worthman(2) | |
| 2,785 | | |
| 2,785 | | |
| | |
| (1) | Consists of (i) 1,300,000 Shares,
(ii) 2,985,715 shares issuable upon exercise of the Pre-Funded Warrants and (iii) 4,285,715 shares issuable upon the exercise of the Common
Warrants. The securities are directly held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (the “Master
Fund”), and may be deemed to be beneficially owned by: (i) Armistice Capital, LLC (“Armistice Capital”), as the investment
manager of the Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. The Pre-Funded Warrants are subject to
a beneficial ownership limitation of 9.99% and the Common Warrants are subject to a beneficial ownership limitation of 4.99%, which in
each case restricts the selling shareholder from exercising that portion of the warrants that would result in the Selling Stockholder
and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The number
of shares set forth in the above table does not reflect the application of this limitation. The address of Armistice Capital Master Fund
Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022. |
| (2) | Each of these Selling
Stockholders is affiliated with H.C. Wainwright & Co., LLC. H.C. Wainwright & Co., LLC is a registered broker dealer
and has a registered address of c/o H.C. Wainwright & Co., LLC 430 Park Ave, 3rd Floor, New York, NY 10022. H.C. Wainwright &
Co., LLC has sole voting and dispositive power over the securities held. The number of shares beneficially owned prior to this offering
consist of shares of common stock issuable upon exercise of Placement Agent Warrants, which were received as compensation for our July
2023 private placement. H.C. Wainwright & Co., LLC acquired the placement agent warrants in the ordinary course of business and,
at the time the placement agent warrants were acquired, H.C. Wainwright & Co., LLC had no agreement or understanding, directly or
indirectly, with any person to distribute such securities. |
PRINCIPAL STOCKHOLDERS
The following table sets forth the beneficial ownership of our Common
Stock as of July 23, 2023, by:
|
● |
each person, or group of affiliated persons, who is known by us to beneficially own more than 5% of our Common Stock; |
|
● |
each of the named executive officers; |
|
● |
each of our directors and director; and |
|
● |
all of our current executive officers and directors as a group |
As of July 23, 2023, we had 13,022,754 shares
of Common Stock outstanding.
We have determined beneficial ownership in accordance
with the rules of the SEC, and thus it represents sole or shared voting or investment power with respect to our securities. Unless otherwise
indicated below, to our knowledge, the persons and entities named in the table have sole voting and sole investment power with respect
to all shares that they beneficially owned, subject to community property laws where applicable. The information does not necessarily
indicate beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of the Exchange Act.
We have based our calculation of the percentage
of beneficial ownership on 13,022,754 shares of our Common Stock outstanding as of July 23, 2023. We have deemed shares of our Common
Stock subject to securities that are currently convertible or exercisable into shares of Common Stock, or convertible or exercisable into
shares of our Common Stock within 60 days of July 23, 2023, to be outstanding and to be beneficially owned by the person holding the stock
option for the purpose of computing the percentage ownership of that person. We did not deem these shares outstanding, however, for the
purpose of computing the percentage ownership of any other person. Unless otherwise indicated, the address of each beneficial owner listed
in the table below is c/o Cadrenal Therapeutics, Inc., 822 A1A North, Suite 306, Ponte Vedra, Florida 32082.
Name of Beneficial Owner |
|
Shares Beneficially Owned |
|
|
Percentage |
|
Named Executive Officers and Directors |
|
|
|
|
|
|
|
|
Quang Pham |
|
|
6,300,000 |
(1) |
|
|
48.38 |
% |
Matthew Szot |
|
|
500,000 |
(2) |
|
|
3.84 |
% |
Douglas Losordo |
|
|
100,000 |
(3) |
|
|
* |
|
John Murphy |
|
|
630,904 |
(4) |
|
|
4.83 |
% |
Steven Zelenkofske |
|
|
58,056 |
(5) |
|
|
* |
|
Glynn Wilson |
|
|
50,000 |
(6) |
|
|
* |
|
Robert Lisicki |
|
|
-- |
(7) |
|
|
-- |
|
All executive officers and directors as a group (6 persons) |
|
|
7,638,960 |
|
|
|
57.97 |
% |
|
|
|
|
|
|
|
|
|
5% Stockholders other than executive officers and directors |
|
|
|
|
|
|
|
|
The PVBQ Living Trust |
|
|
3,000,000 |
(1) |
|
|
23.04 |
% |
Armistice Capital Master Fund Ltd |
|
|
1,300,000 |
(8) |
|
|
9.99 |
% |
* | Represents
beneficial ownership of less than one percent. |
(1) | Includes
(i) 3,300,000 shares of Common Stock owned by Quang Pham; and (ii) 3,000,000 shares of Common Stock owned by The PVBQ Living Trust. The
beneficiary of The PVBQ Living Trust (the “Trust”) is Mr. Pham’s child and Mr. Pham is the trustee of the Trust and
has sole voting and disposition power with respect to the shares owned by the Trust. The address for the Trust is 822 A1A North, Suite
306, Ponte Vedra, Florida 32082. |
(2) |
Consists of 450,000 shares of restricted Common Stock, which shares shall vest quarterly over a period of two (2) years, subject to certain adjustments, and 50,000 shares of Common Stock. |
(3) |
Includes 100,000 shares of Common Stock issuable upon the exercise of options held by Dr. Losordo that are exercisable within the 60-day period following July 23, 2023. Does not include 200,000 shares of Common Stock issuable upon the exercise of options held by Dr. Losordo that are not exercisable within the 60-day period following July 23, 2023. |
(4) |
Includes: (i) 594,792 shares of Common Stock; and (ii) 36,112 shares of Common Stock issuable upon the exercise of options held by Mr. Murphy that are exercisable within the 60-day period following July 23, 2023. Does not include 63,888 shares of Common Stock issuable upon the exercise of options held by Mr. Murphy that are not exercisable within the 60-day period following July 23, 2023. |
(5) |
Includes: (i) 40,000 shares of Common Stock; and (ii) 18,056 shares of Common Stock issuable upon the exercise of options held by Dr. Zelenkofske that are exercisable within the 60-day period following July 23, 2023. Does not include 31,944 shares of Common Stock issuable upon the exercise of options held by Dr. Zelenkofske that are not exercisable within the 60-day period following July 23, 2023. |
(6) | Includes
50,000 shares of Common Stock. Does not include 50,000 shares of Common Stock issuable upon the exercise of options held by Dr. Wilson
that are not exercisable within the 60-day period following July 23, 2023. |
(7) |
Does not include 75,000 shares of Common Stock issuable upon the exercise of options held by Mr. Lisicki that are not exercisable within the 60-day period following July 23, 2023. |
|
|
(8) |
Includes 1,300,000 shares of Common Stock held by Armistice Capital Master Fund Ltd. (the “Master Fund”). Does not include: (i) 2,985,715 shares of Common Stock issuable upon exercise of Pre-Funded Warrants; and (iii) 4,285,715 shares of Common Stock issuable upon exercise of Common Warrants. All of the foregoing securities are directly held by the Master Fund, a Cayman Islands exempted company, and may be deemed to be indirectly beneficially owned by (i) Armistice Capital, LLC (“Armistice”), as the investment manager of the Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. Armistice and Steven Boyd disclaim beneficial ownership of the reported securities except to the extent of their respective pecuniary interest therein. Under the terms of the Common Warrants and Pre-Funded Warrants, Armistice may not exercise the Common Warrants or the Pre-Funded Warrants to the extent such exercise would cause Armistice, together with its affiliates and attribution parties, to beneficially own a number of shares of Common Stock which would exceed 4.99% or 9.99%, as applicable, of our then outstanding Common Stock following such exercise, excluding for purposes of such determination shares of Common Stock issuable upon exercise of such warrants which have not been exercised. The address for Armistice is 510 Madison Avenue, New York, New York 10022. |
Changes In Control
None.
PLAN OF DISTRIBUTION
Each Selling Stockholder of the securities and
any of its pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities covered hereby on
the Nasdaq Capital Market or any other stock exchange, market or trading facility on which the securities are traded or in private transactions.
These sales may be at fixed or negotiated prices. The Selling Stockholders may use any one or more of the following methods when selling
securities:
| ● | ordinary brokerage transactions and transactions in which the broker-dealer
solicits purchasers; |
| ● | block trades in which the broker-dealer will attempt to sell the securities
as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
| ● | purchases by a broker-dealer as principal and resale by the broker-dealer
for its account; |
| ● | an exchange distribution in accordance with the rules of the applicable exchange; |
| ● | privately negotiated transactions; |
| ● | settlement of short sales; |
| ● | in transactions through broker-dealers that agree with the Selling Stockholders
to sell a specified number of such securities at a stipulated price per security; |
| ● | through the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise; |
| ● | a combination of any such methods of sale; or |
| ● | any other method permitted pursuant to applicable law. |
The Selling Stockholders may also sell securities
under Rule 144 or any other exemption from registration under the Securities Act, if available, rather than under this prospectus.
Broker-dealers engaged by the Selling Stockholders
may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders
(or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except
as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary brokerage commission
in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.
In connection with the sale of the securities
or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions,
which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The Selling Stockholders
may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers
that in turn may sell these securities. The Selling Stockholders may also enter into option or other transactions with broker-dealers
or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other
financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may
resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The Selling Stockholders and any broker-dealers
or agents that are involved in selling the securities may be deemed to be “underwriters” within the meaning of the Securities
Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale
of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each Selling Stockholder
has informed us that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute
the securities.
We are required to pay certain fees and expenses
incurred by us incident to the registration of the securities. We have agreed to indemnify the Selling Stockholders against certain losses,
claims, damages and liabilities, including liabilities under the Securities Act.
We agreed to keep this prospectus effective until
the earlier of (i) the date on which the securities may be resold by the Selling Stockholders without registration and without regard
to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for us to be in compliance with the current
public information under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the securities have been
sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will
be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain
states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable
state or an exemption from the registration or qualification requirement is available and is complied with.
Under applicable rules and regulations under the
Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities
with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution.
In addition, the Selling Stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder,
including Regulation M, which may limit the timing of purchases and sales of the common stock by the Selling Stockholders or any other
person. We will make copies of this prospectus available to the Selling Stockholders and have informed them of the need to deliver a copy
of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).
LEGAL MATTERS
The validity of the securities being offered by
this prospectus will be passed upon for us by Blank Rome LLP, New York, New York.
EXPERTS
The financial statements of Cadrenal Therapeutics,
Inc. as of December 31, 2022, and for the period from January 25, 2022 (inception) to December 31, 2022, have been audited by WithumSmith+Brown,
PC, independent registered public accounting firm, as stated in their report, which includes an explanatory paragraph as to the Company’s
ability to continue as a going concern, appearing herein. Such financial statements have been included herein in reliance on the report
of such firm given upon their authority as experts in accounting and auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We have filed with the SEC a registration statement
on Form S-1 under the Securities Act with respect to the shares of our Common Stock offered by this prospectus. This prospectus, which
constitutes a part of the registration statement, does not contain all of the information set forth in the registration statement, as
permitted by the rules and regulations of the SEC. For further information with respect to us and our Common Stock, we refer you to the
registration statement, including the exhibits filed as a part of the registration statement. Statements contained in this prospectus
concerning the contents of any contract or any other document are not necessarily complete. If a contract or document has been filed as
an exhibit to the registration statement, please see the copy of the contract or document that has been filed. Each statement in this
prospectus relating to a contract or document filed as an exhibit is qualified in all respects by the filed exhibit. The SEC also maintains
an Internet website that contains the registration statement of which this prospectus forms a part, as well as the exhibits thereto. These
documents, along with future reports, proxy statements and other information about us, are available at the SEC’s website, www.sec.gov.
We are subject to the information and reporting
requirements of the Exchange Act, and, in accordance with this law, we file periodic reports, proxy statements and other information with
the SEC. These periodic reports, proxy statements and other information will be available at the SEC’s website, www.sec.gov. We
also maintain a website www.cadrenal.com. You may access these materials free of charge as soon as reasonably practicable after they are
electronically filed with, or furnished to, the SEC. Information contained on our website is not a part of this prospectus, and the inclusion
of our website address in this prospectus is an inactive textual reference only.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION
FOR
SECURITIES ACT LIABILITIES
Insofar as indemnification
for liabilities arising under the Securities Act may be permitted to our directors, officers, and controlling persons, we have been informed
that in the opinion of the SEC this indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
INDEX TO FINANCIAL STATEMENTS
INDEX TO UNAUDITED FINANCIAL STATEMENTS
Unaudited
Financial Statements of Cadrenal Therapeutics, Inc.: |
|
FINANCIAL STATEMENTS (UNAUDITED): |
|
BALANCE SHEETS AT MARCH
31, 2023 AND DECEMBER 31, 2022 |
F-22 |
STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND FOR THE PERIOD FROM JANUARY 25, 2022 (INCEPTION) THROUGH MARCH
31, 2022 |
F-23 |
STATEMENTS OF CHANGES IN
STOCKHOLDER’S DEFICIT FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND FOR THE PERIOD FROM JANUARY 25, 2022 (INCEPTION) THROUGH
MARCH 31, 2022 |
F-24 |
STATEMENTS
OF CASH FLOWS FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND FOR THE PERIOD FROM JANUARY 25, 2022 (INCEPTION) THROUGH MARCH 31, 2022 |
F-25 |
NOTES TO THE FINANCIAL
STATEMENTS |
F-26 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Stockholders and Board of Directors of
Cadrenal Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheet of Cadrenal Therapeutics,
Inc. as of December 31, 2022, and the related statements of operations and comprehensive loss, changes in stockholders’ deficit
and cash flows for the period from January 25, 2022 (inception) to December 31, 2022, and the related notes (collectively referred to
as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial
position of the Company at December 31, 2022, and the results of its operations and its cash flows for the period from January 25, 2022
(inception) to December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the entity’s
management. Our responsibility is to express an opinion on the entity’s financial statements based on our audit. We are a public
accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to
be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations
of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB.
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free
of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit
of its internal control over financial reporting. As part of our audit we are required to obtain an understanding of internal control
over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control
over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material
misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures
included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation
of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ WithumSmith+Brown, PC
We have served as the Company's auditor since 2022.
East Brunswick, New Jersey
March 29, 2023
PCAOB ID No. 100
CADRENAL THERAPEUTICS, INC.
BALANCE SHEET
| |
December 31,
2022 | |
Assets: | |
| |
Current assets: | |
| |
Cash | |
$ | 32,586 | |
Prepaid expenses | |
| 22,715 | |
Deferred offering costs | |
| 672,295 | |
Total current assets | |
| 727,596 | |
Property, plant and equipment | |
| 1,013 | |
Right of use assets | |
| 43,578 | |
Other assets | |
| 5,987 | |
Total assets | |
$ | 778,174 | |
Liabilities: | |
| | |
Current liabilities: | |
| | |
Accounts payable | |
$ | 404,897 | |
Accrued liabilities | |
| 863,564 | |
Operating lease liability | |
| 22,288 | |
Promissory note payable, net of debt discount | |
| 43,728 | |
Total current liabilities | |
| 1,334,477 | |
Convertible note payable, net of debt discount - related party | |
| 442,960 | |
Convertible note payable, net of debt discount | |
| 110,380 | |
Derivative liabilities | |
| 4,379,944 | |
Accrued interest | |
| 40,213 | |
Operating lease liability, noncurrent | |
| 21,350 | |
Total liabilities | |
| 6,329,324 | |
Stockholders’ deficit: | |
| | |
Common stock, $0.001 par value; 75,000,000 shares authorized, 8,193,875 issued and outstanding as of December 31, 2022 | |
| 8,194 | |
Additional paid-in capital | |
| 1,154,985 | |
Accumulated deficit | |
| (6,714,329 | ) |
Total stockholders’ deficit | |
| (5,551,150 | ) |
Total liabilities and stockholders’ deficit | |
$ | 778,174 | |
The accompanying notes are an integral part
of these financial statements.
CADRENAL THERAPEUTICS, INC.
STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS
| |
January 25, 2022
(inception) through
December 31,
2022 | |
Operating expenses: | |
| |
General and administrative expenses | |
$ | 2,307,503 | |
Research and development expenses | |
| 392,859 | |
Depreciation expense | |
| 1,266 | |
Total operating expenses | |
| 2,701,628 | |
Loss from operations | |
| (2,701,628 | ) |
Other expense: | |
| | |
Interest expense | |
| 40,192 | |
Interest expense, amortization of debt discount | |
| 66,913 | |
Change in fair value of derivative liabilities | |
| 3,905,596 | |
Total other expenses | |
| 4,012,701 | |
Net loss and comprehensive loss | |
$ | (6,714,329 | ) |
| |
| | |
Net loss per common share, basic and diluted | |
$ | (0.85 | ) |
Weighted average number of common shares used in computing net loss per common share, basic and diluted | |
| 7,890,507 | |
The accompanying notes are an integral part
of these financial statements.
CADRENAL THERAPEUTICS, INC.
STATEMENT OF CHANGES IN STOCKHOLDERS’ DEFICIT
| |
Common Stock | | |
Additional
Paid-In
| | |
Accumulated
| | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Deficit | |
Balance, January 25, 2022 (inception) | |
| - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
Issuance of founder shares | |
| 7,950,000 | | |
| 7,950 | | |
| - | | |
| - | | |
| 7,950 | |
Equity-based compensation - options, restricted stock and RSUs | |
| 243,875 | | |
| 244 | | |
| 927,805 | | |
| - | | |
| 928,049 | |
Issuance of placement agent warrants | |
| - | | |
| - | | |
| 51,621 | | |
| - | | |
| 51,621 | |
Issuance of investor warrants | |
| - | | |
| - | | |
| 175,559 | | |
| - | | |
| 175,559 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (6,714,329 | ) | |
| (6,714,329 | ) |
Balance, December 31, 2022 | |
| 8,193,875 | | |
$ | 8,194 | | |
$ | 1,154,985 | | |
$ | (6,714,329 | ) | |
$ | (5,551,150 | ) |
The accompanying notes are an integral part
of these financial statements.
CADRENAL THERAPEUTICS, INC.
STATEMENT OF CASH FLOWS
| |
January 25, 2022
(inception) through
December 31,
2022 | |
Cash flows from operating activities: | |
| |
Net loss | |
$ | (6,714,329 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | |
Depreciation | |
| 1,266 | |
Stock based compensation | |
| 928,049 | |
Amortization of debt discount | |
| 66,913 | |
Change in fair value of derivative liabilities | |
| 3,905,596 | |
Changes in operating assets and liabilities: | |
| | |
Prepaid expenses | |
| (22,715 | ) |
Deferred offering costs | |
| (672,295 | ) |
Other assets | |
| (5,987 | ) |
Accounts payable | |
| 404,897 | |
Accrued liabilities | |
| 863,622 | |
Accrued interest | |
| 40,213 | |
Net cash used in operating activities | |
| (1,204,770 | ) |
Cash flows used in investing activities: | |
| | |
Investment in property and equipment | |
| (2,279 | ) |
Net cash used in investing activities | |
| (2,279 | ) |
Cash flows from financing activities: | |
| | |
Proceeds from issuance of convertible notes, net of debt issuance costs | |
| 1,011,964 | |
Proceeds from issuance of promissory notes, net of debt issuance costs | |
| 219,721 | |
Proceeds from sale of common stock | |
| 7,950 | |
Net cash provided by financing activities | |
| 1,239,635 | |
Net change in cash | |
| 32,586 | |
Cash – beginning of the period | |
| - | |
Cash – end of the period | |
$ | 32,586 | |
| |
| | |
Supplemental disclosure of non-cash investing activity: | |
| | |
Non-cash right of use assets and operating lease liabilities | |
$ | 47,090 | |
Supplemental disclosure of non-cash financing activity: | |
| | |
Non-cash debt issuance costs - placement agent warrants | |
$ | 51,621 | |
Fair value of financial instruments at issuance | |
$ | 474,349 | |
Issuance of investor warrants | |
$ | 175,559 | |
The accompanying notes are an integral part
of these financial statements.
CADRENAL THERAPEUTICS, INC.
Notes to Financial Statements
Note 1. Description of Business and Summary
of Significant Accounting Policies
Cadrenal Therapeutics, Inc. (the “Company”
or “Cadrenal”) was incorporated on January 25, 2022 (inception) in the State of Delaware and is headquartered in Ponte
Vedra, Florida. Cadrenal is focused on developing a novel therapy with orphan drug indication, tecarfarin, for the prevention of systemic
thromboembolism (blood clots) of cardiac origin in patients with end-stage renal disease (on dialysis) and atrial fibrillation (irregular
heartbeat) or AFib. Tecarfarin is an anticoagulant designed using a drug design process which targets a different pathway than most commonly
prescribed drugs for the treatment of thrombosis and AFib.
Basis of Presentation
The accompanying financial statements have been
prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and applicable rules
and regulations of the U.S. Securities and Exchange Commission (“SEC”) for the fair presentation of the Company’s
financial statements for the period from January 25, 2022 (inception) through December 31, 2022. The Company’s date of inception
was January 25, 2022 and the fiscal year-end is December 31.
Liquidity
In accordance with Accounting Standards Codification (“ASC”)
205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial
doubt about its ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation
initially does not take into consideration the potential mitigating effect of the Company’s plans that have not been fully implemented
as of the date the financial statements are issued. When substantial doubt exists under this methodology, the Company evaluates whether
the mitigating effect of its plans sufficiently alleviates substantial doubt about its ability to continue as a going concern. The mitigating
effect of the Company plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within
one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate
the relevant conditions or events that raise substantial doubt about its ability to continue as a going concern within one year after
the date that the financial statements are issued.
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities
and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability
and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since
inception, the Company has incurred operating losses, and negative cash flows from operations. For the period from January 25, 2022
(inception) to December 31, 2022, the Company had a net loss of $6,714,329 which included $4,901,824 of non-cash expenses. Cash used in
operations for the period January 25, 2022 (inception) to December 31, 2022 totaled $1,204,770. As of December 31, 2022, the Company
had cash of $32,586, negative working capital of $606,881, and an accumulated deficit of $6,714,329. On January 24, 2023, the Company
consummated its initial public offering (the “IPO”) of 1,400,000 shares of its common stock at a public offering price of
$5.00 per share, generating gross proceeds of $7.0 million and net proceeds of $5.4 million.
The Company is projecting that its existing cash
balances as of March 2023 is sufficient to fund its operations for at least the next twelve months from the date of the filing of
its Annual Report on Form 10-K, however, the Company will require additional funding to commence and complete its planned Phase 3
clinical trial and submit its NDA.
Management intends to raise additional funds through
equity and debt financings. However, there can be no assurance that the Company will be able to complete any additional equity or debt
financings on terms acceptable to the Company or at all. If the Company is unable to raise additional funding to meet its working capital
needs in the future, it will be forced to delay or reduce the scope of its research programs and/or limit or cease its operations.
Emerging Growth Company Status
As an “emerging growth company” (“EGC”)
under the Jumpstart Our Business Startups Act (“JOBS Act”), the Company may elect to take advantage of certain forms of relief
from various reporting requirements that are applicable to public companies. The relief afforded under the JOBS Act includes an extended
transition period for the implementation of new or revised accounting standards. The Company has elected to take advantage of this extended
transition period and, as a result, the Company’s financial statements may not be comparable to those of companies that implement
accounting standards as of the effective dates for public companies. The Company may take advantage of the relief afforded under the
JOBS Act up until the last day of the fiscal year following the fifth anniversary of an offering or such earlier time that it is
no longer an EGC.
Use of Estimates
The preparation of financial statements in conformity
with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting
period. Significant estimates and assumptions made in the accompanying financial statements include but are not limited to the fair value
of financial instruments, the fair value of common stock, deferred tax assets and valuation allowance, income tax uncertainties, and
certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors
and adjusts those estimates and assumptions when facts and circumstances change. Actual results could differ from those estimates.
Concentration of Credit and other Risks
and Uncertainties
Financial instruments, which potentially subject
the Company to significant concentrations of credit risk, consist primarily of cash. Cash is maintained at high credit quality financial
institutions and, at times, balances may exceed federally insured limits. All interest-bearing and non-interest-bearing cash balances
are insured up to $250,000 per depositor at each financial institution. The Company has never experienced any losses related to these
balances.
The Company is subject to a number of risks common
for early-stage biopharmaceutical companies including, but not limited to, dependency on the clinical and commercial success of its product
candidates, ability to obtain regulatory approval of its product candidates, the need for substantial additional financing to achieve
its goals, uncertainty of broad adoption of its approved products, if any, by physicians and patients, significant competition and untested
manufacturing capabilities.
Segments
Operating segments are defined as components
of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker
(CODM) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief
Executive Officer. The Company has determined it operates in a single operating segment and has one reportable segment.
Cash and Cash Equivalents
The Company considers all highly liquid investments
purchased with original maturities of three months or less from the purchase date to be cash equivalents. The Company did not have
any cash equivalents at December 31, 2022.
Derivative Financial Instruments
The Company evaluates all of its agreements to
determine if such instruments have derivatives or contain features that qualify as embedded derivatives. The Company accounts for certain
redemption features that are associated with convertible notes as liabilities at fair value and adjusts the instruments to their fair
value at the end of each reporting period. Derivative financial liabilities are initially recorded at fair value, with gains and losses
arising from changes in the fair value recognized in other income (expense) in the accompanying statements of operations and comprehensive
loss for each reporting period while such instruments are outstanding. The embedded derivative liabilities are valued using a probability-weighted
expected return model. If the Company repays the noteholders or if, during the next round of financing, the note holders convert the debt
into equity, the derivative financial liabilities will be de-recognized and reclassified to stockholders’ equity (deficit) on that
date. Derivative instrument liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash
settlement of the derivative instrument could be required within 12 months of the balance sheet date.
Stock-Based Compensation
The Company measures its stock-based awards granted
to employees, consultants and directors based on the estimated fair values of the awards and recognizes the compensation over the requisite
service period. The Company uses the Black-Scholes option-pricing model to estimate the fair value of its stock option awards. Stock-based
compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to
vest, it is reduced by forfeitures. The Company accounts for forfeitures as they occur.
Determination of the Fair Value of Common
Stock
The fair value of the Company’s common
stock for purposes of stock-based awards has been determined by its board of directors. Because there has been no public market for the
Company’s common stock, and in the absence of arm’s-length transactions in the Company’s common stock with independent
third parties, the board of directors has determined the fair value of its common stock with the assistance of an independent third-party
valuation prepared in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid,
Valuation of Privately-Held-Company Equity Securities Issued as Compensation. In assessing the fair value of the Company’s common
stock on each grant date, the Company considered numerous objective and subjective factors, including, but not limited to, the following:
| ● | independent third-party valuation as of May 31, 2022; |
| ● | the Company’s current and expected operating and financial
performance, including our level of available capital resources; |
| ● | the value of the Company’s tangible and intangible
assets; |
| ● | market conditions affecting comparable public companies,
as reflected in comparable companies’ market trading multiples, initial public offering valuations, comparable sales or merger
transactions, and other metrics; |
| ● | the illiquidity of the Company’s common stock by virtue
of being a private company, and the resulting discount for lack of marketability; |
| ● | the business risks we face; |
| ● | the likelihood of achieving a particular liquidity event,
such as a sale, a merger, or an initial public offering, given prevailing pharmaceutical and biotechnology industry and capital markets
conditions; and |
| ● | the experience of management and the board of directors |
Deferred Offering Costs
The Company capitalizes certain legal, professional,
and other third-party costs that are directly associated with in-process equity financings until such financings are consummated at which
time such costs are recorded against the gross proceeds of the offering. Should an in-process equity financing be abandoned, the deferred
offering costs will be expensed immediately as a charge to operating expenses in the statements of operations and comprehensive loss.
As of December 31, 2022, deferred offering costs were $672,295 and are included on the accompanying balance sheet.
Acquisitions
The Company evaluates acquisitions of assets
and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition
by first applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated
in a single identifiable asset or group of similar identifiable assets. If so, the transaction is accounted for as an asset acquisition.
If not, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to
create outputs, which would meet the definition of a business. Significant judgment is required in the application of the screen test
to determine whether an acquisition is a business combination or an acquisition of assets.
Acquisitions meeting the definition of business
combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the
net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair
values of the net assets acquired is recorded as goodwill.
For asset acquisitions, a cost accumulation model
is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition.
The Company also evaluates which elements of a transaction should be accounted for as a part of an asset acquisition and which should
be accounted for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired
and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between
the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based
on their relative fair values. When a transaction accounted for as an asset acquisition includes an in-process research and development
(“IPR&D”) asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular
research and development project. For an IPR&D asset to have an alternative future use: (a) the Company must reasonably expect
that it will use the asset acquired in the alternative manner and anticipate economic benefit from that alternative use, and (b) the
Company’s use of the asset acquired is not contingent on further development of the asset subsequent to the acquisition date (that
is, the asset can be used in the alternative manner in the condition in which it existed at the acquisition date). Otherwise, amounts
allocated to IPR&D that have no alternative use are expensed to research and development. Asset acquisitions may include contingent
consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial
targets. Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of
payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis.
Income Taxes
Income taxes are accounted for under the asset
and liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial
statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected
to affect taxable income. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. A
valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.
Due to the Company’s historical operating performance and net losses, the net deferred tax assets have been fully offset by a valuation
allowance.
The Company recognizes uncertain income tax positions
at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax
position will not be recognized if it has less than a 50% likelihood of being sustained. Changes in recognition or measurement are reflected
in the period in which judgment occurs. The Company’s policy is to recognize interest and penalties related to the underpayment
of income taxes as a component of the provision for income taxes.
Net Loss Per Common Share
Basic net loss per common share is calculated
by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for
potential dilutive shares of common stock. Diluted net loss per common share is computed by dividing net loss by the weighted average
number of shares of common stock and common stock equivalents of potentially dilutive securities outstanding for the period determined
using the treasury stock or if-converted methods. Since the Company was in a loss position for all periods presented, basic net loss
per common share is the same as diluted net loss per common share since the effects of potentially dilutive securities are anti-dilutive.
Shares of common stock subject to repurchase are excluded from the weighted-average shares.
Comprehensive Loss
Comprehensive loss is defined as the change in
equity during a period from transactions and other events or circumstances from non-owner sources. Net loss and comprehensive loss were
the same for the period presented in the accompanying financial statements.
Research and Development Expenses
Research and development costs are expensed as
incurred and consist of fees paid to other entities that conduct certain research and development activities on the Company’s behalf.
Acquired intangible assets are expensed as research and development costs if, at the time of payment, the technology is under development;
is not approved by the FDA or other regulatory agencies for marketing; has not reached technical feasibility; or otherwise has no foreseeable
alternative future use. Non-refundable advance payments for goods or services to be received in the future for use in research and development
activities are capitalized and then expensed as the related goods are delivered or the services are performed.
For the period from January 25, 2022 (inception)
through December 31, 2022, the Company’s research and development expenses were comprised primarily of the cost of the acquired
tecarfarin asset and related transaction costs, as well as stock-based compensation and consulting services.
Patents
Patent costs are comprised primarily of external
legal fees, filing fees incurred to file patent applications, and periodic renewal fees to keep the patent in force and are expensed
as incurred as a component of general and administrative expense.
Note 2. Recent Accounting Guidance
Recent Accounting Pronouncements
In August 2020, the FASB issued ASU No. 2020-06,
Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts
in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity, which simplifies
the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and
contracts on an entity’s own equity.
ASU 2020-06 is effective on a prospective
basis for annual reporting periods beginning after December 15, 2023 and for interim periods within those periods. Early adoption
is permitted. The Company adopted ASU 2020-06 on January 25, 2022 (inception). The adoption of ASU 2020-06 did not have a material
impact on the Company’s financial position and results of operations.
Note 3. Fair Value Measurements
Assets and liabilities recorded at fair value
on a recurring basis in the balance sheet are categorized based upon the level of judgment associated with the inputs used to measure
their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid
to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market
participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and
minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy
for disclosure of fair value measurements as follows:
| ● | Level 1 — |
Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. |
| ● | Level 2 — |
Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability. These
include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities
in markets that are not active. |
| ● | Level 3 — |
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
The Company classifies its embedded derivative
liability as a Level 3 financial instrument and measures and reports its embedded derivatives at fair value.
Financial liabilities subject to fair value measurements
on a recurring basis and the level of inputs used in such measurements by major security type as of December 31, 2022 are presented
in the following table:
| |
December 31, 2022 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Financial Liabilities: | |
| | | |
| | | |
| | | |
| | |
Derivative liabilities | |
$ | — | | |
$ | — | | |
$ | 4,379,944 | | |
$ | 4,379,944 | |
Total Financial Liabilities | |
$ | — | | |
$ | — | | |
$ | 4,379,944 | | |
$ | 4,379,944 | |
| |
Derivative
liabilities | |
Balance at January 25, 2022 | |
$ | - | |
Fair value of financial instruments at issuance | |
| 474,348 | |
Change in fair value | |
| 3,905,596 | |
Balance at December 31, 2022 | |
$ | 4,379,944 | |
The carrying amounts of cash, prepaid expenses,
deferred offering costs, accounts payable, and accrued liabilities approximate their fair values due to their short-term nature. There
were no transfers of liabilities among the fair value measurement categories during any of the periods presented.
Note 4. Accrued Liabilities
Accrued liabilities consist of the following:
| |
December 31, 2022 | |
Accrued consulting fees | |
$ | 165,192 | |
Accrued compensation | |
| 605,290 | |
Other | |
| 93,082 | |
Total accrued liabilities | |
$ | 863,564 | |
Note 5. Asset Purchase Agreement
On April 1, 2022, the Company completed
an asset purchase agreement with HESP LLC, the assignee of tecarfarin and related assets (the “Asset Purchase Agreement”).
Pursuant to the terms of the Asset Purchase Agreement, the Company acquired all of the assets of HESP LLC, including all intellectual
property and other rights related to tecarfarin, the tecarfarin IND 77041, all rights under the license, development and commercialization
agreement dated as of September 16, 2015 by and between Armetheon, Inc. (“Armetheon”) (which was later assigned by Armetheon
to Espero BioPharma, Inc. (“Espero”), and China Cardiovascular Focus Ltd, an affiliate of Lee’s Pharmaceutical Holdings
Limited (“Lee’s Pharmaceutical”), relating to tecarfarin and related trademarks. In consideration of the purchase of
the assets, the Company paid HESP LLC $100,000 on the closing date and paid an additional $100,000 on June 1, 2022. As additional
consideration, the Company agreed to pay HESP LLC the following development milestone payments:
Development Milestones | |
Milestone Payments | |
Completion of enrollment of Lee’s Pharmaceutical Phase 3 clinical trial | |
$ | 250,000 | |
First MAA submitted in the People’s Republic of China | |
| 350,000 | |
First Commercial Sale to a Third Party | |
$ | 1,200,000 | |
Financing Milestones
As additional consideration, the Company agreed
to pay the following amounts, up to $2,000,000, upon each financing milestone as follows (i) 35% of any proceeds received from any
licensing or partnering revenue; and (ii) IPO proceeds. The aggregate payments under the development milestone payments and financing
milestone payments shall not exceed $2,000,000.
The Company accounted for the transaction as
an asset acquisition as substantially all of the estimated fair value of the gross assets acquired was concentrated in a single identified
in-process research and development asset, the tecarfarin asset, thus satisfying the requirements of the screen test in accordance with
the criteria under ASC 805-10-55-5C. The assets acquired in the transaction were measured based on the fair value of the consideration
paid including the direct transaction costs of $20,095, as the fair value of the consideration paid was more readily determinable than
the fair value of the assets acquired. The following table summarizes the purchase price of the assets acquired:
In process research and development | |
$ | 200,000 | |
Transaction costs | |
| 20,095 | |
Total | |
$ | 220,095 | |
All costs the Company incurred in connection
with this Asset Purchase Agreement were recognized as research and development expenses in the Company’s statement of operations
and comprehensive loss as these assets had no alternative future use at the time of the acquisition transaction. Due to the nature of
the regulatory, sales and financing-based milestones, the contingent consideration was not included in the initial cost of assets purchased
as they are contingent upon events that are outside the Company’s control.
However, upon achievement or anticipated achievement
of each milestone, the Company will recognize the related appropriate payment as additional research and development expense. Contingent
consideration will not be recorded until it is probable the milestone events occur.
On August 18, 2022, the Company entered
into an Amendment to Asset Purchase Agreement, whereby in lieu of the $1,800,000 cash payment that would have been due to HESP LLC pursuant
to the Asset Purchase Agreement as a result of an initial public offering, HESP LLC agreed to accept shares of the Company’s common
stock, such number of shares to be calculated based upon a 40% discount to the price of the Company’s common stock sold in the
initial public offering. If and when it is determined that it is probable this financing-based milestone (initial public offering) will
be achieved, the Company will recognize the payment of $3.0 million as research and development expense.
As of December 31, 2022, none of the contingent
events have occurred.
Note 6. Debt
Debt outstanding is presented on the balance
sheet as follows:
| |
December 31,
2022 | |
Convertible notes payable - related parties | |
$ | 550,000 | |
Debt issuance costs | |
| (107,040 | ) |
| |
| 442,960 | |
| |
| | |
Convertible note payable | |
| 575,000 | |
Debt issuance costs | |
| (464,620 | ) |
| |
| 110,380 | |
| |
| | |
Promissory note payable | |
| 250,000 | |
Debt issuance costs | |
| (206,272 | ) |
| |
| 43,728 | |
| |
| | |
Total debt, net | |
$ | 597,068 | |
March 2022 Convertible Note
In March 2022, the Company entered into
a convertible promissory note agreement (the “March 2022 Note”) and received cash proceeds of $500,000. The March 2022
Note bears interest at a rate equal to simple interest of 5.0% per annum computed on the basis of the 360-day year of twelve (12) 30-day months.
The March 2022 Note is due and payable on March 1, 2025, unless earlier converted or repaid.
Pursuant to the March 2022 Note, the principal
and accrued but unpaid interest will be automatically converted into equity securities sold in the Next Equity Financing of the Company
comprising a single transaction or a series of related transactions in which total proceeds of at least $3.0 million is raised.
The principal and unpaid and accrued interest of the March 2022 Note at the date of conversion will be converted into shares at
a conversion price equal to 80% of the price per share paid by investors purchasing such shares in the Next Equity Financing. If the
Company consummates a Change of Control prior to repayment in full of the March 2022 Note, immediately prior to the Change of Control,
the outstanding principal and any unpaid and accrued interest will automatically convert into common equity of the Company (or directly
into proceeds paid to the holders of common equity in connection with the Change of Control) at a price per share that is 80% of the
price per share of common equity paid at the Change of Control.
The Company evaluated whether the March 2022
Note contains embedded features that meet the definition of derivatives under FASB ASC 815, Derivatives and Hedging. The Company
determined that these redemption features contained rights and obligations for conversion contingent upon a potential future financing
event or a change in control. Thus, the embedded put options were bifurcated from the face value of the March 2022 Note and accounted
for as a derivative liability to be remeasured at the end of each reporting period with the change in the fair value included in other
expense, in the accompanying statement of operations and comprehensive loss. The fair value of the put option derivative liability at
issuance was $104,883, with the offsetting amount being recorded as a debt discount. Debt issuance costs totaled $1,460. The debt discount
and debt issuance costs are being amortized to interest expense using the effective interest method over the expected term of the March 2022
Note. The effective interest rate of the March 2022 Note is 12.1% compared to a stated interest rate of 5.0%.
June 2022 Convertible Note
In June 2022, the Company entered into a
convertible promissory note agreement (the “June 2022 Note”) and received cash proceeds of $50,000. The June 2022
Note bears interest at a rate equal to simple interest of 6.0% per annum computed on the basis of the 360-day year of twelve (12) 30-day months.
The June 2022 Note is due and payable on June 13, 2025, unless earlier converted or repaid.
Pursuant to the June 2022 Note, the principal
and accrued but unpaid interest will be automatically converted into equity securities sold in the Next Equity Financing of the Company
comprising a single transaction or a series of related transactions in which total proceeds of at least $3.0 million is raised.
The principal and unpaid and accrued interest of the June 2022 Note at the date of conversion will be converted into shares at a
conversion price equal to 60% of the price per share paid by investors purchasing such shares in the Next Equity Financing. If the Company
consummates a Change of Control prior to repayment in full of the June 2022 Note, immediately prior to the Change of Control, the
outstanding principal and any unpaid and accrued interest will automatically convert into common equity of the Company (or directly into
proceeds paid to the holders of common equity in connection with the Change of Control) at a price per share that is 60% of the price
per share of common equity paid at the Change of Control.
The Company evaluated whether the June 2022
Note contains embedded features that meet the definition of derivatives under FASB ASC 815, Derivatives and Hedging. The Company
determined that these redemption features contained rights and obligations for conversion contingent upon a potential future financing
event or a change in control. Thus, the embedded put options were bifurcated from the face value of the June 2022 Note and accounted
for as a derivative liability to be remeasured at the end of each reporting period with the change in the fair value included in other
expense, in the accompanying statement of operations and comprehensive loss. The fair value of the put option derivative liability at
issuance was $29,532, with the offsetting amount being recorded as a debt discount. The debt discount is amortized to interest expense
using the effective interest method over the expected term of the June 2022 Note. The effective interest rate of the June 2022
Note is 25.7% compared to a stated interest rate of 6.0%.
Boustead Private Placement Notes
In July 2022, the Company issued convertible
promissory notes in the aggregate amount of $450,000 (the “July 2022 Notes”), in August 2022, the Company
issued a convertible promissory note in the amount of $50,000 (the “August 2022 Note”) and in September 2022, the
Company issued convertible promissory notes in the aggregate amount of $75,000 (the “September 2022 Notes”). The July 2022
Notes, the August 2022 Note and the September 2022 Note bear interest at 6% and mature on September 13, 2025 (“Maturity
Date”).
The principal amount due under the July 2022
Notes, the August 2022 Note and the September 2022 Notes (and, at the Company’s option, any accrued but unpaid interest
under the July 2022 Notes, the August 2022 Note and the September 2022 Notes) will be automatically converted, on or before
the Maturity Date, into Next Equity Securities in the Next Equity Financing. The July 2022 Notes, the August 2022 Note and
September 2022 Notes are convertible into shares of common stock at a conversion price equal to the quotient obtained by dividing
(i) the entire principal amount of the July 2022 Notes, the August 2022 Note and the September 2022 Notes, plus (if
applicable) any accrued but unpaid interest under the July 2022 Notes, the August 2022 Note and the September 2022 Notes
by (ii) sixty percent (60%) of the price per share of the Next Equity Securities sold in the Next Equity Financing. In the event
of a Change of Control which occurs prior to repayment in full of the July 2022 Notes, the August 2022 Note or the September 2022
Notes, immediately prior to the Change of Control, the outstanding principal and any accrued but unpaid interest on the July 2022
Notes, the August 2022 Note and the September 2022 Notes will convert directly into our common equity (or directly into proceeds
paid to the holders of our common equity in connection with the Change of Control) at a price per share that is 60% of the price per
share of common equity paid at the Change of Control. Boustead Securities, LLC acted as the placement agent for the private placement
and received as part of its compensation and five-year warrants to purchase shares of our common stock at a price equal to the conversion
price of the Private Placement Notes in an amount equal to 6% of the shares of common stock underlying the Private Placement Notes. The
Company has determined that the warrants issued to the placement agent receive equity treatment. The warrants were recorded at fair value
at issuance and recorded as debt issuance costs associated with the Boustead Private Placement Notes.
The Company has determined the redemption features
in the July 2022 Notes, August 2022 Note and September 2022 Notes contain rights and obligations for conversion contingent
upon a potential future financing event or a change in control, and that such features are required to be bifurcated from the host debt
instrument and accounted for as a derivative liability to be remeasured at the end of each reporting period.
The Company evaluated whether the July, August,
and September 2022 Notes contain embedded features that meet the definition of derivatives under FASB ASC 815, Derivatives
and Hedging. The Company determined that these redemption features contained rights and obligations for conversion contingent upon a
potential future financing event or a change in control. Thus, the embedded put options were bifurcated from the face value of the July,
August and September Notes and accounted for as a derivative liabilities to be remeasured at the end of each reporting period with the
change in the fair value included in other expense, in the accompanying statements of operations and comprehensive loss. The fair value
of the put option derivative liabilities at issuance was $339,934, with the offsetting amount being recorded as a debt discount. The
debt discount is being amortized to interest expense using the effective interest method over the expected term of the July, August and
September 2022 Notes. The effective interest rates of the July, August and September 2022 Notes were 36.3%, 26.1%, and 28.8%,
respectively, compared to a stated interest rate of 6.0%.
Non-Convertible Promissory Note
On November 30, 2022, the Company closed a $250,000
note offering (the “November Private Placement”) pursuant to which the Company sold to two accredited investors units consisting
of (i) notes in the aggregate principal amount of $250,000, which bear interest at the rate of 10%, repayable at the earlier of the time
of the completion of the IPO or November 30, 2023 (the “November Notes”) and (ii) warrants to purchase up to an aggregate
of 250,000 shares of common stock exercisable at $1.00 per common share, which are exercisable at any time and are automatically exercised
into shares of the Company’s common stock upon the consummation of the IPO (the “November Warrants”). At the time the
November Notes and November Warrants were sold, it was intended that the principal amount of the November Notes would be repaid upon
the consummation of the IPO out of the proceeds of the November Warrants exercise.
The issuance of the November Warrants triggered
an adjustment to the conversion price of the Private Placement Notes (the July 2022, August 2022 and September 2022 Notes) to $1.00 per
share, pursuant to down-round protection included in those notes. As a result of the adjustment of the conversion price of the Private
Placement Notes, the five-year warrants issued to Boustead Securities, LLC in connection with the Private Placement, were amended to
provide for the purchase of an aggregate of 11,500 shares of the Company’s common stock at an exercise price equal to 60% of the
initial public offering price per share.
The Company also issued 15,000 warrants to Boustead
for the placement of the November financing. The November placement agent warrants have an exercise price of $1.00 per common share.
In December 2022, the Company entered into amendments
to the March 2022 Note and the June 2022 Note to adjust the conversion price of the March 2022 Note and the June 2022 Note to $1.00 per
common share. The March 2022 Note and June 2022 Note originally had a conversion price equal to 80% and 60%, respectively, of the IPO
price. While this amendment was not required, as the March 2022 Note and June 2022 did not have down-round protection like the Private
Placement Notes, the amendment was entered into to provide the investors in the March and June Notes with the same conversion price as
the Private Placement notes.
The Company incurred debt issuance costs attributed to the November
Notes, which were recorded as a debt discount.
Note 7. Related Party Transactions
On January 25, 2022, the Company into an
agreement with Phamace, LLC, a consulting firm of which Quang Pham, the Company’s Chief Executive Officer, is the sole member,
for an initial term of January 25, 2022 through February 28, 2022. Pursuant to the agreement, the Company shall pay the sum
of $115,000 to Phamace, LLC for advisory and administrative services rendered relating to preparing the Company to launch as an operating
company, which is due and payable on September 30, 2022.
On January 25, 2022, the Company issued 7,500,000
shares of common stock, pursuant to a subscription agreement, to Quang Pham, our Chief Executive Officer, of which 3,000,000 were subsequently
transferred to a related trust, of which Mr. Pham’s child is a beneficiary and Mr. Pham is the trustee with sole voting
and disposition power with respect to the shares owned by the trust, 1,100,000 were subsequently transferred to friends, family and a
trust of which Mr. Pham’s child is a beneficiary, but of which Mr. Pham has no voting or disposition power, and 125,000 were transferred
to non-profit organizations. Mr. Pham paid a total of $7,500 for such founders shares.
On March 1, 2022, the Company issued a convertible
promissory note in the amount of $500,000 to John Murphy, a member of the Company’s board of directors, which bears interest at
5% and matures on March 1, 2025. The note is convertible into shares of Common Stock at a conversion price equal to the quotient
obtained by dividing (i) the entire principal amount of the note plus (if applicable) any accrued but unpaid interest under the
Note by (ii) eighty percent (80%) of the price per share of the equity securities issued and sold at the initial closing of our
next equity financing. See Note 6 for further discussion.
On May 17, 2022, the Company issued 450,000
shares of restricted common stock, pursuant to a restricted stock purchase agreement, to Matthew Szot its Chief Financial Officer, which
shares shall vest quarterly over a period of two years, subject to certain adjustments, as provided in the Restricted Stock Purchase
Agreement dated May 17, 2022.
On August 22, 2022, the Company issued a convertible
promissory note in the amount of $50,000 to Glynn Wilson, a member of the Company’s board of directors, which bears interest at
6% and matures on September 13, 2025. See Note 6 for further discussion.
Note 8. Leases, Commitments, and Contingencies
Leases
At lease inception, the Company determines if
an arrangement is an operating or capital lease. For operating leases, the Company recognized rent expense, inclusive of rent escalation,
on a straight-line basis over the lease term.
In accordance with ASC 842, Leases, the Company
determines if an arrangement is or contains a lease at inception. A contract is or contains a lease if the contract conveys the right
to control the use of an identified asset for a period of time in exchange for consideration. The Company classifies leases at the lease
commencement date as operating or finance leases and records a right-of-use asset and a lease liability on the balance sheet for all
leases with an initial lease term of greater than 12 months. Leases with an initial term of 12 months or less are not recorded in the
balance sheet, but payments are recognized as expenses on a straight-line basis over the lease term. The Company has elected not to recognize
leases with terms of 12 months or less.
A lease qualifies as a finance lease if any of
the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company
by the end of the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise,
(iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease
payments equals or exceeds substantially all of the fair value of the leased asset, or (v) the nature of the leased asset is specialized
to the point that it is expected to provide the lessor no alternative use at the end of the lease term. All other leases are recorded
as operating leases.
The Company enters into contracts that contain
both lease and non-lease components. Non-lease components may include maintenance, utilities, and other operating costs. The Company
combines the lease and non-lease components of fixed costs in its lease arrangements as a single lease component. Variable costs, such
as utilities or maintenance costs, are not included in the measurement of right-of-use assets and lease liabilities but rather are expensed
when the event determining the amount of variable consideration to be paid occurs.
Finance and operating lease assets and liabilities
are recognized at the lease commencement date based on the present value of the lease payments over the lease term using the discount
rate implicit in the lease. If the rate implicit is not readily determinable, the Company utilizes an estimate of its incremental borrowing
rate based upon the available information at the lease commencement date. Operating lease assets are further adjusted for prepaid or
accrued lease payments. Operating lease payments are expensed using the straight-line method as an operating expense over the lease term.
The Company’s operating lease ROU assets
and liabilities as of December 31, 2022 are as follows:
| |
December 31,
2022 | |
Assets | |
| |
Operating lease ROU assets | |
$ | 43,578 | |
Liabilities | |
| | |
Current | |
| | |
Operating lease liabilities | |
$ | 22,288 | |
Noncurrent | |
| | |
Operating lease liabilities | |
| 21,350 | |
Total operating lease liabilities | |
$ | 43,638 | |
Operating lease expense was $4,394 for the year ended December 31,
2022. Cash paid for amounts included in the measurement of operating lease liabilities included in operating cash flows was $4,334 for
the year ended December 31, 2022. The remaining operating lease term was 22 months, and the operating lease discount rate was 12% as
of December 31, 2022.
Future annual lease payments under non-cancellable
operating leases as of December 31, 2022 were as follows:
2023 | |
$ | 26,068 | |
2024 | |
| 22,319 | |
Total lease payments | |
| 48,387 | |
Less: Imputed interest | |
| 4,749 | |
Total operating lease liabilities | |
$ | 43,638 | |
Contingencies
In the normal course of business, the Company
enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications.
The Company’s exposure under these agreements is unknown, because it involves claims that may be made against the Company in the
future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will
be made and such expenditures can be reasonably estimated.
Indemnification
In accordance with the Company’s certificate
of incorporation and bylaws, the Company indemnifies its officers and directors for certain events or occurrences, subject to certain
limits, while they are serving in such capacity. There have been no claims to date, and the Company has a directors and officers liability
insurance policy that may enable it to recover a portion of any amounts paid for future claims.
Note 9. Stockholders’ Equity and
Warrants
Common Stock
Pursuant to the Certificate of Incorporation
filed on January 25, 2022, the Company was authorized to issue a total of 10,000,000 shares of common stock with a par value of
$0.001 per share. On December 5, 2022, the Company filed an Amended and Restated Certificate of Incorporation to increase the authorized
capital stock of the Company to 82,500,000 shares, consisting of 75,000,000 shares of common stock, par value $0.001 per share, and 7,500,000
shares of preferred stock, par value $0.001 per share, which was approved by the Company’s Board of Directors, as well as a majority
of the Company’s shareholders, on December 5, 2022.
Holders of common stock are entitled to one vote
for each share of common stock held of record for the election of the Company’s directors and all other matters requiring stockholder
action. Holders of common stock will be entitled to receive such dividends, if any, as may be declared from time to time by the Company’s
Board in its discretion out of funds legally available therefor.
As of December 31, 2022, 8,193,875 shares
of common stock were issued and outstanding.
Warrants
The following table summarizes the total warrants
outstanding at December 31, 2022:
| |
Issue
Date | |
Exercise
Price
Per Share | | |
Expiration
Date | | |
Outstanding
as of
January 25, 2022 | | |
New
Issuance | | |
Expired | | |
Outstanding
as of
December 31,
2022 | |
Placement
agent warrants | |
July - Sept 2022 | |
$ | 3.00 | | |
| July - Sept 2027 | | |
| - | | |
| 11,500 | | |
| - | | |
| 11,500 | |
Placement
agent warrants | |
Nov 2022 | |
$ | 1.00 | | |
| Nov 2027 | | |
| - | | |
| 15,000 | | |
| - | | |
| 15,000 | |
Investor
warrants | |
Nov 2022 | |
$ | 1.00 | | |
| Earlier of IPO or Nov 2027 | | |
| - | | |
| 250,000 | | |
| - | | |
| 250,000 | |
| |
| |
| | | |
| | | |
| - | | |
| 276,500 | | |
| - | | |
| 276,500 | |
Note 10. Equity-Based Compensation
The Company adopted the Cadrenal Therapeutics,
Inc. 2022 Equity Incentive Plan, or the Initial Plan, on July 11, 2022, which was later amended and restated on October 16,
2022, for purposes of clarifying the application of certain of the rules of the Initial Plan to awards approved before such amendment
and restatement of the Initial Plan and to facilitate the transition to the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive
Plan (the “Successor Plan”) for the issuance and approval of awards after consummation of this offering. On October 16,
2022, the Board adopted and the Company’s stockholders approved the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive
Plan, or the 2022 Plan, which will be a successor to and continuation of the Initial Plan and became effective on January 19, 2023. Upon
the effectiveness of the 2022 Plan, it replaced the Initial Plan, except with respect to awards outstanding under the Initial Plan, and
no further awards will be available for grant under the Initial Plan.
Subject to certain adjustments, the maximum number
of shares of common stock that could have been issued under the Plans in connection with awards was 2,000,000 shares, of which 810,000
remained available for issuance as December 31, 2022. The maximum number of shares of common stock that may be issued under the 2022
Plan will automatically increase on January 1 of each calendar year for a period of ten years commencing on January 1,
2023 and ending on (and including) January 1, 2032, to a number of shares of common stock equal to 20% of the total number of shares
of common stock outstanding on December 31 of the preceding calendar year; provided, however that the board of directors, or the
compensation committee, may act prior to January 1 of a given calendar year to provide that the increase for such year will be a
lesser number of shares of common stock. All available shares may be utilized toward the grant of any type of award under the 2022 Plan.
The Company measures its stock-based awards granted
to employees, consultants and directors based on the estimated fair values of the awards and recognizes the compensation over the requisite
service period. The Company uses the Black-Scholes option-pricing model to estimate the fair value of its stock option awards. Stock-based
compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to
vest, it is reduced by forfeitures. The Company accounts for forfeitures as they occur.
Weighted average assumptions used in the Black-Scholes
model are set forth below:
|
|
December 31,
2022 |
Risk-free
interest rate |
|
2.98% – 4.10% |
Dividend
yield |
|
— |
Expected
term (years) |
|
5.27 – 5.81 |
Volatility |
|
62.4% – 62.5% |
On July 11, 2022, the Company granted stock
options to purchase 650,000 shares of common stock at an exercise price of $0.64 per common share. The stock option grants were issued
to directors, members of the Scientific Advisory Board, and other consultants to the Company and vest in periods ranging from one to
three years.
On August 18, 2022, the Company issued stock
options to purchase 300,000 shares of common stock to our Chief Medical Officer. The options have an exercise price of $0.64 per common
share and will vest quarterly over a period of three years, subject to certain adjustments.
On August 18, 2022, the Company granted
stock options to purchase 100,000 shares of common stock at an exercise price of $0.64 per common share. The stock option grants were
issued to members of the Scientific Advisory Board and vest over three years.
Activity under the Plans for the period from
January 25, 2022 (inception) to December 31, 2022 is set forth below:
| |
Number Outstanding | | |
Weighted- Average Exercise Price Per Share | | |
Weighted- Average Remaining Contractual Life (Years) | | |
Aggregate Intrinsic Value | |
Outstanding at January 25, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Granted | |
| 1,100,000 | | |
| 0.84 | | |
| 9.57 | | |
| 4,578,000 | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Canceled/forfeited/expired | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding at December 31, 2022 | |
| 1,100,000 | | |
$ | 0.84 | | |
| 9.57 | | |
$ | 4,578,000 | |
Options vested and exercisable at December 31, 2022 | |
| 108,330 | | |
$ | 0.64 | | |
| 9.55 | | |
$ | 427,629 | |
Options vested and expected to vest as of December 31, 2022 | |
| 1,100,000 | | |
$ | 0.84 | | |
| 9.57 | | |
$ | 4,578,000 | |
The weighted average grant date fair value of
options granted to date was $1.11. At December 31, 2022, the Company had $1,048,151 of unrecognized stock-based compensation expense
related to stock options which will be recognized over the weighted average remaining requisite service period of 2.2 years. The
Company settles employee stock option exercises with newly issued shares of common stock.
On July 11, 2022, the Company issued restricted
stock of 46,875 shares of common stock to a consultant. These shares fully vested on October 1, 2022.
On August 18, 2022, the Company issued 40,000
shares of common stock to a consultant. These shares were fully vested upon the date of grant.
On August 18, 2022, the Company issued 40,000
shares of common stock to Steven Zelenkofske, a director, for recruiting services performed. These shares were fully vested upon the
date of grant.
On September 16, 2022, the Company issued
50,000 shares of common stock to John Murphy, a director. These shares were fully vested upon the date of grant.
On October 3, 2022, the Company issued 137,000
shares of common stock to various consultants for services rendered. 70,000 of the shares were subsequently returned and canceled. These
shares were fully vested upon the date of grant.
On October 3, 2022, the Company issued stock
options to purchase 50,000 shares of common stock to a director. The options have an exercise price of $5.00 per common share and vest
over a three-year period, with 33.33% vesting on the first anniversary of the effective date, and thereafter 1/36 on a monthly basis.
Total stock compensation expense for the period
from January 25, 2022 (inception) to December 31, 2022 was $928,049.
The allocation of stock-based compensation for
the period presented below was as follows:
| |
January 25, 2022 (Inception) to December 31, 2022 | |
General and administrative | |
$ | 791,247 | |
Research and development | |
| 136,802 | |
Total stock-based compensation | |
$ | 928,049 | |
Note 11. Net Loss Per Share
The following table sets forth the computation
of the basic and diluted net loss per common share:
| |
January 25, 2022 (Inception) to December 31, 2022 | |
Numerator: | |
| |
Net loss | |
$ | (6,714,329 | ) |
Denominator: | |
| | |
Weighted average common shares outstanding | |
| 7,890,507 | |
Net loss per share, basic and diluted | |
$ | (0.85 | ) |
Since the Company was in a loss position for
the period presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive securities
would have been anti-dilutive. For the period from inception to December 31, 2022, there were no potential dilutive securities other
than the convertible notes, stock options, and warrants.
Note 12. Income Taxes
The Company’s income (loss) before provision
(benefit) for income taxes for the period ended December 31, 2022 was generated in the following jurisdictions:
| |
January 25, 2022 (Inception) to December 31, 2022 | |
Domestic | |
$ | (6,714,329 | ) |
Foreign | |
| — | |
Loss before income taxes | |
$ | (6,714,329 | ) |
The Company’s provision is $0, which is
primarily driven by the federal and state statutory income tax rates on current year losses, offset by the Company’s full valuation
allowance.
The components of income tax expense (benefit)
were as follows:
| |
| January 25, 2022 (Inception) to December 31, 2022 | |
Current | |
| | |
Federal | |
$ | — | |
State | |
| — | |
Foreign | |
| — | |
Total current provision | |
| — | |
Deferred: | |
| | |
Federal | |
| — | |
State | |
| — | |
Foreign | |
| — | |
Total deferred provision | |
| — | |
Provision for income taxes | |
$ | — | |
A reconciliation of income tax expense to the
amount computed by applying the statutory federal income tax rate to the loss from operations is summarized for the period ended December
31, 2022, as follows:
| |
January 25, 2022 (Inception) to December 31, 2022 | |
Tax benefit at statutory tax rate | |
$ | (1,410,009 | ) |
State benefit, net of federal benefit | |
| (263,978 | ) |
Permanent differences | |
| 8,910 | |
Equity-based compensation | |
| 125,248 | |
Derivatives | |
| 1,003,603 | |
Increase in valuation allowance | |
| 536,226 | |
| |
$ | — | |
Deferred income taxes reflect the net tax effects
of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used
for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities at December 31, 2022 are shown
below. The Company has established a full valuation allowance against net deferred tax assets due to the uncertainty that such assets
will be realized. The Company periodically evaluates the recoverability of its deferred tax assets. At such time as it is determined
that it is more likely than not that the deferred tax asset will be realized, the valuation allowance will be reduced. The increase in
the valuation allowances of $479,000 for the period from January 25, 2022 (inception) to December 31, 2022 was primarily due to
the Company’s net operating losses and basis differences in intangible assets generated during the current year.
The components of deferred tax assets and liabilities
consisted of the following at December 31, 2022:
| |
December 31, 2022 | |
Deferred tax assets: | |
| |
Net operating loss carry forwards | |
$ | 298,000 | |
Equity-based compensation | |
| 44,000 | |
Capitalized research costs | |
| 55,000 | |
Accruals and other temporary differences | |
| 135,000 | |
Total deferred tax assets | |
| 532,000 | |
Convertible debt | |
| (53,000 | ) |
Valuation allowance for deferred tax assets | |
| (479,000 | ) |
Net deferred tax asset | |
$ | — | |
As of December 31, 2022, the Company has net
operating loss carryforwards of approximately $1.2 million and $1.2 million available to reduce future taxable income, if any, for federal
and state income tax purposes, respectively. The Company’s US federal and state net operating loss carryovers can be carried forward
indefinitely, but the deduction related to these net operating losses is limited to 80% of taxable income when utilized in future years.
The utilization of net operating loss carryforwards
and tax credit carryovers could be subject to annual limitations under Section 382 and 383 of the Internal Revenue Code of 1986,
and similar state tax provisions, due to ownership change limitations that may have occurred previously or that could occur in the future.
These ownership changes limit the amount of net operating loss carryforwards and other deferred tax assets that can be utilized to offset
future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382 and 383, results from transactions
increasing ownership of certain stockholders or public groups in the stock of the corporation by more than 50 percentage points over
a three-year period. The Company has not conducted an analysis of an ownership change under section 382. To the extent that a study is
completed and an ownership change is deemed to occur, the Company’s net operating losses and tax credits could be limited.
The Company applies the two-step approach to
recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the
weight of available evidence indicates it is more likely than not that the position will be sustained upon audit, including resolution
of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount, which is more
than 50% likely of being realized upon ultimate settlement. Income tax positions must meet a more likely than not recognition threshold
to be recognized under ASC 740 upon initial measurement and in subsequent periods. ASC 740-10 also provides guidance on measurement,
derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition.
At December 31, 2022, the Company did not have
any significant uncertain tax positions. The Company will recognize interest and penalties related to uncertain tax positions in income
tax expense. As of December 31, 2022, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts
have been recognized in the Company’s statement of operations and comprehensive loss. The Company does not anticipate a material
change to unrecognized tax benefits in the next twelve months.
All of the Company’s tax years will
remain open for examination by the federal and state taxing authorities to the extent that the Company’s tax attributes are utilized
in future years to offset income or income taxes.
Note 13.
Subsequent Events
The Company
has evaluated events that occurred through March 29, 2023, the date that the financial statements were issued and determined that there
have been no events that have occurred that would require adjustments to our disclosures in the financial statements except for the transactions
described below:
On January
24, 2023, the Company consummated its initial public offering (the “IPO”) of 1,400,000 shares of its common stock at a public
offering price of $5.00 per share, generating gross proceeds of $7,000,000. The Company’s shares of common stock commenced trading
on the Nasdaq Capital Market on January 20, 2023, under the symbol “CVKD.”
In connection
with the IPO, on January 19, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with
Boustead Securities, LLC, as representative of the underwriters (the “Representative”). Pursuant to the Underwriting
Agreement, the Company agreed to issue to the underwriters a five-year warrant (the “Representative’s Warrant”) to
purchase an aggregate of 84,000 shares of the Company’s common stock, which is equal to six percent (6%) of the shares of
common stock sold in the IPO. Such Representative’s Warrant has an exercise price of $6.00, which is equal to 120% of the public
offering price of the common stock in the IPO.
On January
19, 2023, the Company issued 600,000 shares of common stock to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase
Agreement, dated August 18, 2022, between the Company and HESP LLC. The Company recognized the payment of $3.0 million as research
and development expense in January 2023. See Note 5 for further discussion.
On January
24, 2023, concurrent with the consummation of the IPO, the Company issued 1,140,700 shares of common stock upon conversion of the convertible
promissory notes. See Note 6 for further discussion.
On January
24, 2023, the Company issued 250,000 shares of common stock upon the exercise of the November Warrants. The $250,000 of proceeds of the
warrant exercise were used to pay off the $250,000 November Notes. See Note 6 for further discussion.
After the
closing of the IPO, the Company granted 50,000 shares of the Company’s common stock to the Company’s Chief Financial Officer.
CADRENAL
THERAPEUTICS, INC.
BALANCE
SHEETS
| |
March 31, 2023 | | |
December 31, 2022 | |
| |
(unaudited) | | |
| |
Assets: | |
| | |
| |
Current assets: | |
| | |
| |
Cash | |
$ | 4,028,367 | | |
$ | 32,586 | |
Prepaid expenses | |
| 410,903 | | |
| 22,715 | |
Deferred offering costs | |
| - | | |
| 672,295 | |
Total current assets | |
| 4,439,270 | | |
| 727,596 | |
Property, plant and equipment | |
| 823 | | |
| 1,013 | |
Right of use assets | |
| 38,180 | | |
| 43,578 | |
Other assets | |
| 3,791 | | |
| 5,987 | |
Total assets | |
$ | 4,482,064 | | |
$ | 778,174 | |
Liabilities: | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 119,567 | | |
$ | 404,897 | |
Accrued liabilities | |
| 258,906 | | |
| 863,564 | |
Operating lease liability | |
| 23,162 | | |
| 22,288 | |
Promissory note payable, net of debt discount | |
| - | | |
| 43,728 | |
Total current liabilities | |
| 401,635 | | |
| 1,334,477 | |
Convertible note payable, net of debt discount - related parties | |
| - | | |
| 442,960 | |
Convertible note payable, net of debt discount | |
| - | | |
| 110,380 | |
Derivative liabilities | |
| - | | |
| 4,379,944 | |
Accrued interest | |
| - | | |
| 40,213 | |
Operating lease liability, noncurrent | |
| 15,167 | | |
| 21,350 | |
Total liabilities | |
| 416,802 | | |
| 6,329,324 | |
Stockholders’ equity (deficit): | |
| | | |
| | |
Common stock, $0.001 par value; 75,000,000 shares authorized, 11,722,754 shares issued and outstanding as of March 31, 2023; 8,193,875 shares issued and outstanding as of December 31, 2022 | |
| 11,722 | | |
| 8,194 | |
Additional paid-in capital | |
| 15,941,443 | | |
| 1,154,985 | |
Accumulated deficit | |
| (11,887,903 | ) | |
| (6,714,329 | ) |
Total stockholders’ equity (deficit) | |
| 4,065,262 | | |
| (5,551,150 | ) |
Total liabilities and stockholders’ equity (deficit) | |
$ | 4,482,064 | | |
$ | 778,174 | |
The
accompanying notes are an integral part of these financial statements.
CADRENAL
THERAPEUTICS, INC.
STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
| |
Three Months Ended
March 31, 2023 | | |
January 25, 2022
(inception) through
March 31, 2022 | |
Operating expenses: | |
| | |
| |
General and administrative expenses | |
$ | 964,732 | | |
$ | 152,661 | |
Research and development expenses | |
| 3,235,317 | | |
| 17,860 | |
Depreciation expense | |
| 190 | | |
| - | |
Total operating expenses | |
| 4,200,239 | | |
| 170,521 | |
Loss from operations | |
| (4,200,239 | ) | |
| (170,521 | ) |
Other expense: | |
| | | |
| | |
Interest expense | |
| 3,534 | | |
| 2,081 | |
Interest expense, amortization of debt discount | |
| 13,567 | | |
| 2,508 | |
Change in fair value of derivative liabilities | |
| 216,095 | | |
| 1,538 | |
Loss on extinguishment of debt | |
| 740,139 | | |
| - | |
Total other expenses | |
| 973,335 | | |
| 6,127 | |
Net loss and comprehensive loss | |
$ | (5,173,574 | ) | |
$ | (176,648 | ) |
| |
| | | |
| | |
Net loss per common share, basic and diluted | |
$ | (0.48 | ) | |
$ | (0.02 | ) |
Weighted average number of common shares used in computing net loss per common share, basic and diluted | |
| 10,772,493 | | |
| 7,500,000 | |
The
accompanying notes are an integral part of these financial statements.
CADRENAL
THERAPEUTICS, INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
(unaudited)
|
|
Common Stock |
|
|
Additional Paid-In |
|
|
Accumulated |
|
|
Total
Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Equity (Deficit) |
|
Balance, December 31, 2022 |
|
|
8,193,875 |
|
|
$ |
8,194 |
|
|
$ |
1,154,985 |
|
|
$ |
(6,714,329 |
) |
|
$ |
(5,551,150 |
) |
Issuance of common shares in initial public offering, net of offering costs |
|
|
1,400,000 |
|
|
|
1,400 |
|
|
|
5,407,175 |
|
|
|
- |
|
|
|
5,408,575 |
|
Issuance of common shares to settle convertible debt |
|
|
1,140,700 |
|
|
|
1,140 |
|
|
|
1,139,560 |
|
|
|
- |
|
|
|
1,140,700 |
|
De-recognition of derivative liabilities |
|
|
- |
|
|
|
- |
|
|
|
4,596,039 |
|
|
|
- |
|
|
|
4,596,039 |
|
Issuance of common shares from exercise of warrants |
|
|
250,000 |
|
|
|
250 |
|
|
|
249,750 |
|
|
|
- |
|
|
|
250,000 |
|
Issuance of common shares to settle asset purchase obligation |
|
|
600,000 |
|
|
|
600 |
|
|
|
2,999,400 |
|
|
|
- |
|
|
|
3,000,000 |
|
Issuance of restricted common shares for prepaid consulting services |
|
|
77,340 |
|
|
|
77 |
|
|
|
108,199 |
|
|
|
- |
|
|
|
108,276 |
|
Equity-based compensation - options, restricted stock and RSUs |
|
|
60,839 |
|
|
|
61 |
|
|
|
286,335 |
|
|
|
- |
|
|
|
286,396 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5,173,574 |
) |
|
|
(5,173,574 |
) |
Balance, March 31, 2023 |
|
|
11,722,754 |
|
|
$ |
11,722 |
|
|
$ |
15,941,443 |
|
|
$ |
(11,887,903 |
) |
|
$ |
4,065,262 |
|
| |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity (Deficit) | |
Balance, January 25, 2022 | |
| - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
Issuance of founder shares | |
| 7,500,000 | | |
| 7,500 | | |
| - | | |
| - | | |
| 7,500 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (176,648 | ) | |
| (176,648 | ) |
Balance, March 31, 2022 | |
| 7,500,000 | | |
$ | 7,500 | | |
$ | - | | |
$ | (176,648 | ) | |
$ | (169,148 | ) |
The
accompanying notes are an integral part of these financial statements.
CADRENAL
THERAPEUTICS, INC.
STATEMENTS OF CASH FLOWS
(unaudited)
| |
Three Months Ended March 31, 2023 | | |
January 25, 2022 (inception) through March 31, 2022 | |
Cash flows from operating activities: | |
| | |
| |
Net loss | |
$ | (5,173,574 | ) | |
$ | (176,648 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation expense | |
| 190 | | |
| - | |
Equity-based compensation | |
| 286,396 | | |
| - | |
Amortization of debt discount | |
| 13,567 | | |
| 2,508 | |
Change in fair value of derivative liabilities | |
| 216,095 | | |
| 1,538 | |
Loss on extinguishment of debt | |
| 740,139 | | |
| - | |
Non-cash lease expense | |
| 89 | | |
| - | |
Issuance of shares to settle asset purchase agreement | |
| 3,000,000 | | |
| - | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses | |
| (279,912 | ) | |
| (2,206 | ) |
Deferred offering costs | |
| 672,295 | | |
| - | |
Other assets | |
| 2,196 | | |
| (1,097 | ) |
Accounts payable | |
| (285,330 | ) | |
| 15,123 | |
Accrued liabilities | |
| (604,945 | ) | |
| 117,083 | |
Net cash used in operating activities | |
| (1,412,794 | ) | |
| (43,699 | ) |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from issuance of convertible notes, net of debt issuance costs | |
| - | | |
| 498,540 | |
Proceeds from issuance of founder shares | |
| - | | |
| 7,500 | |
Proceeds from exercise of warrants | |
| 250,000 | | |
| - | |
Repayment of promissory notes | |
| (250,000 | ) | |
| - | |
Proceeds from sale of common stock in initial public offering, net of offering costs | |
| 5,408,575 | | |
| - | |
Net cash provided by financing activities | |
| 5,408,575 | | |
| 506,040 | |
Net change in cash | |
| 3,995,781 | | |
| 462,341 | |
Cash – beginning of the period | |
| 32,586 | | |
| - | |
Cash – end of the period | |
$ | 4,028,367 | | |
$ | 462,341 | |
| |
| | | |
| | |
Supplemental disclosure of non-cash financing activity: | |
| | | |
| | |
Issuance of common shares to settle convertible debt | |
$ | 1,140,700 | | |
$ | - | |
De-recognition of derivative liabilities | |
$ | 4,596,039 | | |
$ | - | |
Issuance of common shares for prepaid consulting services | |
$ | 108,276 | | |
$ | - | |
The
accompanying notes are an integral part of these financial statements.
CADRENAL
THERAPEUTICS, INC.
Notes to Financial Statements
Note 1.
Description of Business and Summary of Significant Accounting Policies
Cadrenal Therapeutics, Inc. (the “Company”
or “Cadrenal”) was incorporated on January 25, 2022 (inception) in the State of Delaware and is headquartered in Ponte
Vedra, Florida. Cadrenal is focused on developing a novel therapy with orphan drug and fast-track designations, tecarfarin, for the prevention
of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage renal disease and atrial fibrillation (irregular
heartbeat) or AFib. Tecarfarin is an anticoagulant designed using a drug design process which targets a different pathway than most commonly
prescribed drugs for the treatment of thrombosis and AFib.
Basis
of Presentation
The
accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States
of America (GAAP) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for the
fair presentation of the Company’s financial statements for the periods presented. The Company’s date of inception was January 25,
2022 and the fiscal year-end is December 31.
Liquidity
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the
realization of assets and settlement of liabilities and commitments in the normal course of business. The financial statements do not
reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the
Company is unable to continue as a going concern. Since inception, the Company has incurred operating losses, and negative cash flows
from operations. For the three months ended March 31, 2023, the Company had a net loss of $5,173,574, which included $4,256,475 of non-cash
expenses. Cash used in operations for the three months ended March 31, 2023 totaled $1,412,794. As of March 31, 2022, the Company had
cash of $4,028,367, working capital of $4,037,635, and an accumulated deficit of $11,887,903.
The Company is projecting that its existing cash
balance as of May 9, 2023 is sufficient to fund its operations for at least the next twelve months from the date of the filing of
its Quarterly Report on Form 10-Q, however, the Company will require additional funding to commence and complete its planned Phase 3
clinical trial and submit its NDA.
Management intends to raise additional funds through
partnering and equity and debt financings. However, there can be no assurance that the Company will be able to complete partnering transactions
or financings on terms acceptable to the Company or at all. If the Company is unable to raise additional funding to meet its working capital
needs in the future, it will be forced to delay or reduce the scope of its research programs and/or limit or cease its operations.
Emerging
Growth Company Status
As
an “emerging growth company” (“EGC”) under the Jumpstart Our Business Startups Act (“JOBS Act”),
the Company may elect to take advantage of certain forms of relief from various reporting requirements that are applicable to public
companies. The relief afforded under the JOBS Act includes an extended transition period for the implementation of new or revised accounting
standards. The Company has elected to take advantage of this extended transition period and, as a result, the Company’s financial
statements may not be comparable to those of companies that implement accounting standards as of the effective dates for public companies.
The Company may take advantage of the relief afforded under the JOBS Act up until the last day of the fiscal year following the
fifth anniversary of an offering or such earlier time that it is no longer an EGC.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and
the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial
statements include but are not limited to the fair value of financial instruments, the fair value of common stock, deferred tax assets
and valuation allowance, income tax uncertainties, and certain accruals. The Company evaluates its estimates and assumptions on an ongoing
basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances change.
Actual results could differ from those estimates.
Concentration
of Credit and other Risks and Uncertainties
Financial instruments, which potentially subject
the Company to significant concentrations of credit risk, consist primarily of cash. Cash is maintained at high credit quality financial
institutions and, at times, balances may exceed federally insured limits. All interest-bearing and non-interest-bearing cash balances
are insured up to $250,000 per depositor at each financial institution. The Company has never experienced any losses related to these
balances. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial
condition, results of operations, and cash flows.
The
Company is subject to a number of risks common for early-stage biopharmaceutical companies including, but not limited to, dependency
on the clinical and commercial success of its product candidate, ability to obtain regulatory approval of its product candidate, the
need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians
and patients, significant competition and untested manufacturing capabilities.
Segments
Operating
segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed
by the Chief Operating Decision Maker (CODM) in deciding how to allocate resources to an individual segment and in assessing performance.
The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in a single operating segment and has
one reportable segment.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date
to be cash equivalents. The Company did not have any cash equivalents at March 31, 2023 or December 31, 2022.
Derivative
Financial Instruments
The
Company evaluates all of its agreements to determine if such instruments have derivatives or contain features that qualify as embedded
derivatives. The Company accounts for certain redemption features that are associated with convertible notes as liabilities at fair value
and adjusts the instruments to their fair value at the end of each reporting period. Derivative financial liabilities are initially recorded
at fair value, with gains and losses arising from changes in the fair value recognized in other income (expense) in the accompanying
statements of operations and comprehensive loss for each reporting period while such instruments are outstanding. The embedded derivative
liabilities are valued using a probability-weighted expected return model. If the Company repays the noteholders or if, during the next
round of financing, the noteholders convert the debt into equity, the derivative financial liabilities will be de-recognized and reclassified
to stockholders’ equity (deficit) on that date. Derivative instrument liabilities are classified in the balance sheet as current
or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the
balance sheet date.
Concurrent
with the closing of the initial public offering in January 2023, the note holders converted the debt into common stock, accordingly,
the derivative financial liabilities were de-recognized and reclassified to stockholders’ equity (deficit) on January 24, 2023.
Stock-Based
Compensation
The
Company measures its stock-based awards granted to employees, consultants, and directors based on the estimated fair values of the awards
and recognizes the compensation over the requisite service period. The Company uses the Black-Scholes option-pricing model to estimate
the fair value of its stock option awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation
expense is based on awards ultimately expected to vest, it is reduced by forfeitures. The Company accounts for forfeitures as they occur.
Deferred
Offering Costs
The
Company capitalizes certain legal, professional, and other third-party costs that are directly associated with in-process equity financings
until such financings are consummated, at which time such costs are recorded against the gross proceeds of the offering. Should an in-process
equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements
of operations and comprehensive loss. The Company completed its initial public offering on January 24, 2023, and the offering costs were
recorded against the proceeds of the offering. As of March 31, 2022, there were no deferred offering costs.
Acquisitions
The
Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted
for as a business combination or asset acquisition by first applying a screen test to determine whether substantially all of the fair
value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If so, the
transaction is accounted for as an asset acquisition. If not, further determination is required as to whether or not the Company has
acquired inputs and processes that have the ability to create outputs, which would meet the definition of a business. Significant judgment
is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of
assets.
Acquisitions
meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the
purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the
purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.
For
asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized
as part of the cost of an asset acquisition. The Company also evaluates which elements of a transaction should be accounted for as a
part of an asset acquisition and which should be accounted for separately. The cost of an asset acquisition, including transaction costs,
is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized
in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated
to the non-monetary identifiable assets based on their relative fair values. When a transaction accounted for as an asset acquisition
includes an in-process research and development (“IPR&D”) asset, the IPR&D asset is only capitalized if it has an
alternative future use other than in a particular research and development project. For an IPR&D asset to have an alternative future
use: (a) the Company must reasonably expect that it will use the asset acquired in an alternative manner and anticipate economic
benefit from that alternative use, and (b) the Company’s use of the asset acquired is not contingent on the further development
of the asset subsequent to the acquisition date (that is, the asset can be used in an alternative manner in the condition in which it
existed at the acquisition date). Otherwise, amounts allocated to IPR&D that have no alternative use are expensed to research and
development. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments
to sellers contingent upon the achievement of future financial targets. Contingent consideration is not recognized until all contingencies
are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired
on a relative fair value basis.
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based
on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year
in which the differences are expected to affect taxable income. Management makes an assessment of the likelihood that the resulting deferred
tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred
tax asset will not be realized. Due to the Company’s historical operating performance and net losses, the net deferred tax assets
have been fully offset by a valuation allowance.
The
Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the
relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained.
Changes in recognition or measurement are reflected in the period in which judgment occurs. The Company’s policy is to recognize
interest and penalties related to the underpayment of income taxes as a component of the provision for income taxes.
Net
Loss Per Common Share
Basic
net loss per common share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding
for the period, without consideration for potential dilutive shares of common stock. Diluted net loss per common share is computed by
dividing net loss by the weighted average number of shares of common stock and common stock equivalents of potentially dilutive securities
outstanding for the period determined using the treasury stock or if-converted methods. Since the Company was in a loss position for
all periods presented, basic net loss per common share is the same as diluted net loss per common share since the effects of potentially
dilutive securities are anti-dilutive. Shares of common stock subject to repurchase are excluded from the weighted-average shares.
Comprehensive
Loss
Comprehensive
loss is defined as the change in equity during a period from transactions and other events or circumstances from non-owner sources. Net
loss and comprehensive loss were the same for the periods presented in the accompanying financial statements.
Research
and Development Expenses
Research
and development costs are expensed as incurred and consist of fees paid to other entities that conduct certain research and development
activities on the Company’s behalf. Acquired intangible assets are expensed as research and development costs if, at the time of
payment, the technology is under development; is not approved by the FDA or other regulatory agencies for marketing; has not reached
technical feasibility; or otherwise has no foreseeable alternative future use. Non-refundable advance payments for goods or services
to be received in the future for use in research and development activities are capitalized and then expensed as the related goods are
delivered or the services are performed.
Patents
Patent
costs are comprised primarily of external legal fees, filing fees incurred to file patent applications, and periodic renewal fees to
keep the patent in force and are expensed as incurred as a component of general and administrative expenses.
Note 2.
Recent Accounting Guidance
Recent
Accounting Pronouncements
In
August 2020, the FASB issued ASU No. 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20)
and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible
Instruments and Contracts in an Entity, which simplifies the accounting for certain financial instruments with characteristics of liabilities
and equity, including convertible instruments and contracts on an entity’s own equity.
ASU 2020-06
is effective on a prospective basis for annual reporting periods beginning after December 15, 2023 and for interim periods within
those periods. Early adoption is permitted. The Company adopted ASU 2020-06 on January 25, 2022 (inception). The adoption of ASU 2020-06
did not have a material impact on the Company’s financial position and results of operations.
Note 3.
Fair Value Measurements
Assets
and liabilities recorded at fair value on a recurring basis in the balance sheet are categorized based upon the level of judgment associated
with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or
an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an
orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize
the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes
a three-tier fair value hierarchy for disclosure of fair value measurements as follows:
|
● |
Level
1 — |
Observable
inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. |
|
● |
Level
2 — |
Inputs
(other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability. These include
quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities
in markets that are not active. |
|
● |
Level
3 — |
Unobservable
inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
The
Company classified its embedded derivative liability as a Level 3 financial instrument and measured and reported its embedded derivatives
at fair value. Concurrent with the closing of the initial public offering in January 2023, the note holders converted the debt into common
stock, accordingly, the derivative financial liabilities were de-recognized and reclassified to stockholders’ equity (deficit)
on January 24, 2023.
Financial
liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security
type are presented in the following table:
| |
| March 31, 2023 | |
| |
| Level 1 | | |
| Level 2 | | |
| Level 3 | | |
| Fair Value | |
Financial Liabilities: | |
| | | |
| | | |
| | | |
| | |
Derivative liabilities | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
Total Financial Liabilities | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| |
December 31, 2022 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Financial Liabilities: | |
| | |
| | |
| | |
| |
Derivative liabilities | |
$ | - | | |
$ | - | | |
$ | 4,379,944 | | |
$ | 4,379,944 | |
Total Financial Liabilities | |
$ | - | | |
$ | - | | |
$ | 4,379,944 | | |
$ | 4,379,944 | |
| |
Derivative
liabilities | |
Balance at January 25, 2022 | |
$ | - | |
Fair value of financial instruments at issuance | |
| 474,348 | |
Change in fair value | |
| 3,905,596 | |
Balance at December 31, 2022 | |
$ | 4,379,944 | |
| |
Derivative
liabilities | |
Balance at December 31, 2022 | |
$ | 4,379,944 | |
Change in fair value | |
| 216,095 | |
Settlement of derivative liability | |
| (4,596,039 | ) |
Balance at March 31, 2023 | |
$ | - | |
The
carrying amounts of cash, prepaid expenses, deferred offering costs, accounts payable, and accrued liabilities approximate their fair
values due to their short-term nature. There were no transfers of liabilities among the fair value measurement categories during any
of the periods presented.
Note 4.
Accrued Liabilities
Accrued
liabilities consist of the following:
| |
March 31, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Accrued consulting fees | |
$ | 49,560 | | |
$ | 165,192 | |
Accrued compensation | |
| 170,283 | | |
| 605,290 | |
Other | |
| 39,063 | | |
| 93,082 | |
Total accrued liabilities | |
$ | 258,906 | | |
$ | 863,564 | |
Note 5.
Asset Purchase Agreement
On
April 1, 2022, the Company completed an asset purchase agreement with HESP LLC, the assignee of tecarfarin and related assets (the
“Asset Purchase Agreement”). Pursuant to the terms of the Asset Purchase Agreement, the Company acquired all of the assets
of HESP LLC, including all intellectual property and other rights related to tecarfarin, the tecarfarin IND 77041, all rights under
the license, development and commercialization agreement dated as of September 16, 2015 by and between Armetheon, Inc. (“Armetheon”)
(which was later assigned by Armetheon to Espero BioPharma, Inc. (“Espero”), and China Cardiovascular Focus Ltd, an affiliate
of Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharmaceutical”), relating to tecarfarin and related trademarks.
In consideration of the purchase of the assets, the Company paid HESP LLC $100,000 on the closing date and paid an additional $100,000
on June 1, 2022. As additional consideration, the Company agreed to pay HESP LLC the following development milestone payments:
Development Milestones | |
Milestone Payments | |
Completion of enrollment of Lee’s Pharmaceutical Phase 3 clinical trial | |
$ | 250,000 | |
First MAA submitted in the People’s Republic of China | |
| 350,000 | |
First Commercial Sale to a Third Party | |
$ | 1,200,000 | |
Financing
Milestones
As
additional consideration, the Company agreed to pay the following amounts, up to $2,000,000, upon each financing milestone as follows
(i) 35% of any proceeds received from any licensing or partnering revenue; and (ii) IPO proceeds. The aggregate payments under
the development milestone payments and financing milestone payments shall not exceed $2,000,000.
The
Company accounted for the transaction as an asset acquisition as substantially all of the estimated fair value of the gross assets acquired
was concentrated in a single identified in-process research and development asset, the tecarfarin asset, thus satisfying the requirements
of the screen test in accordance with the criteria under ASC 805-10-55-5C. The assets acquired in the transaction were measured
based on the fair value of the consideration paid including the direct transaction costs of $20,095, as the fair value of the consideration
paid was more readily determinable than the fair value of the assets acquired. The following table summarizes the initial purchase price
of the assets acquired:
In process research and development | |
$ | 200,000 | |
Transaction costs | |
| 20,095 | |
Total | |
$ | 220,095 | |
All
costs the Company incurred in connection with this Asset Purchase Agreement were recognized as research and development expenses in the
Company’s statement of operations and comprehensive loss as these assets had no alternative future use at the time of the acquisition
transaction. Due to the nature of the regulatory, sales and financing-based milestones, the contingent consideration was not included
in the initial cost of assets purchased as they are contingent upon events that are outside the Company’s control.
However,
upon achievement or anticipated achievement of each milestone, the Company will recognize the related appropriate payment as additional
research and development expense. Contingent consideration will not be recorded until it is probable the milestone events occur.
On August 18, 2022, the Company entered into
an Amendment to Asset Purchase Agreement, whereby in lieu of the $1,800,000 cash payment that would have been due to HESP LLC pursuant
to the Asset Purchase Agreement as a result of an initial public offering, HESP LLC agreed to accept shares of the Company’s common
stock, such number of shares to be calculated based upon a 40% discount to the price of the Company’s common stock sold in the initial
public offering.
As
of December 31, 2022, none of the contingent events have occurred. On January 19, 2023, the Company issued 600,000 shares of common
stock to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase Agreement, dated August 18, 2022, between the Company
and HESP LLC. The Company recognized the stock payment of $3.0 million as research and development expense on January 19, 2023.
Note 6.
Debt
Debt
outstanding is presented on the balance sheet as follows:
| |
March 31, 2023 | | |
December 31, 2022 | |
Convertible notes payable - related parties | |
$ | - | | |
$ | 550,000 | |
Debt issuance costs | |
| - | | |
| (107,040 | ) |
| |
| - | | |
| 442,960 | |
| |
| | | |
| | |
Convertible note payable | |
| - | | |
| 575,000 | |
Debt issuance costs | |
| - | | |
| (464,620 | ) |
| |
| - | | |
| 110,380 | |
| |
| | | |
| | |
Promissory note payable | |
| - | | |
| 26,404 | |
Debt issuance costs | |
| - | | |
| 250,000 | |
| |
| - | | |
| 276,404 | |
| |
| | | |
| | |
Total debt, net | |
$ | - | | |
$ | 829,744 | |
March 2022
Convertible Note
In
March 2022, the Company entered into a convertible promissory note agreement (the “March 2022 Note”) and received
cash proceeds of $500,000. The March 2022 Note bore interest at a rate equal to simple interest of 5.0% per annum computed on the
basis of the 360-day year of twelve (12) 30-day months. The March 2022 Note was due and payable on March 1, 2025,
unless earlier converted or repaid.
Pursuant
to the March 2022 Note, the principal and accrued but unpaid interest was to be automatically converted into equity securities sold
in the Next Equity Financing of the Company comprising a single transaction or a series of related transactions in which total proceeds
of at least $3.0 million is raised. The principal and unpaid and accrued interest of the March 2022 Note at the date of conversion
was to be converted into shares at a conversion price equal to 80% of the price per share paid by investors purchasing such shares in
the Next Equity Financing. If the Company consummated a Change of Control (as defined in the March 2022 Note) prior to repayment in full
of the March 2022 Note, immediately prior to the Change of Control, the outstanding principal and any unpaid and accrued interest
would be automatically converted into common equity of the Company (or directly into proceeds paid to the holders of common equity in
connection with the Change of Control) at a price per share that is 80% of the price per share of common equity paid at the Change of
Control.
The
Company evaluated whether the March 2022 Note contained embedded features that met the definition of derivatives under FASB ASC 815,
Derivatives and Hedging. The Company determined that these redemption features contained rights and obligations for conversion contingent
upon a potential future financing event or a change in control. Thus, the embedded put options were bifurcated from the face value of
the March 2022 Note and accounted for as a derivative liability to be remeasured at the end of each reporting period with the change
in the fair value included in other expense, in the accompanying statement of operations and comprehensive loss. The fair value of the
put option derivative liability at issuance was $104,883, with the offsetting amount being recorded as a debt discount. Debt issuance
costs totaled $1,460. The debt discount and debt issuance costs were being amortized to interest expense using the effective interest
method over the expected term of the March 2022 Note. The effective interest rate of the March 2022 Note was 12.1% compared
to a stated interest rate of 5.0%.
June 2022
Convertible Note
In
June 2022, the Company entered into a convertible promissory note agreement (the “June 2022 Note”) and received
cash proceeds of $50,000. The June 2022 Note bore interest at a rate equal to simple interest of 6.0% per annum computed on the
basis of the 360-day year of twelve (12) 30-day months. The June 2022 Note was due and payable on June 13, 2025,
unless earlier converted or repaid.
Pursuant
to the June 2022 Note, the principal and accrued but unpaid interest was to be automatically converted into equity securities sold
in the Next Equity Financing of the Company comprising a single transaction or a series of related transactions in which total proceeds
of at least $3.0 million is raised. The principal and unpaid and accrued interest of the June 2022 Note at the date of conversion
was to be converted into shares at a conversion price equal to 60% of the price per share paid by investors purchasing such shares in
the Next Equity Financing. If the Company consummated a Change of Control (as defined in the June 2022 Note) prior to repayment in full
of the June 2022 Note, immediately prior to the Change of Control, the outstanding principal and any unpaid and accrued interest
would automatically convert into common equity of the Company (or directly into proceeds paid to the holders of common equity in connection
with the Change of Control) at a price per share that is 60% of the price per share of common equity paid at the Change of Control.
The
Company evaluated whether the June 2022 Note contained embedded features that meet the definition of derivatives under FASB ASC 815,
Derivatives and Hedging. The Company determined that these redemption features contained rights and obligations for conversion contingent
upon a potential future financing event or a change in control. Thus, the embedded put options were bifurcated from the face value of
the June 2022 Note and accounted for as a derivative liability to be remeasured at the end of each reporting period with the change
in the fair value included in other expenses, in the accompanying statement of operations and comprehensive loss. The fair value of the
put option derivative liability at issuance was $29,532, with the offsetting amount being recorded as a debt discount. The debt discount
was amortized to interest expense using the effective interest method over the expected term of the June 2022 Note. The effective
interest rate of the June 2022 Note was 25.7% compared to a stated interest rate of 6.0%.
Boustead
Private Placement Notes
In
July 2022, the Company issued convertible promissory notes in the aggregate amount of $450,000 (the “July 2022 Notes”),
in August 2022, the Company issued a convertible promissory note in the amount of $50,000 (the “August 2022 Note”)
and in September 2022, the Company issued convertible promissory notes in the aggregate amount of $75,000 (the “September 2022
Notes” and together with the July 2022 Note and the August 2022 Note, the “Private Placement Notes”). The July 2022
Notes, the August 2022 Note and the September 2022 Note bore interest at 6% and mature on September 13, 2025 (“Maturity
Date”).
The
principal amount due under the July 2022 Notes, the August 2022 Note and the September 2022 Notes (and, at the Company’s
option, any accrued but unpaid interest under the July 2022 Notes, the August 2022 Note and the September 2022 Notes)
was to be automatically converted, on or before the Maturity Date, into Next Equity Securities in the Next Equity Financing. The July 2022
Notes, the August 2022 Note and September 2022 Notes were convertible into shares of common stock at a conversion price equal
to the quotient obtained by dividing (i) the entire principal amount of the July 2022 Notes, the August 2022 Note and
the September 2022 Notes, plus (if applicable) any accrued but unpaid interest under the July 2022 Notes, the August 2022
Note and the September 2022 Notes by (ii) sixty percent (60%) of the price per share of the Next Equity Securities sold in
the Next Equity Financing. In the event of a Change of Control (as defined in the Private Placement Notes) which occurred prior to repayment
in full of the July 2022 Notes, the August 2022 Note or the September 2022 Notes, immediately prior to the Change of Control,
the outstanding principal and any accrued but unpaid interest on the July 2022 Notes, the August 2022 Note and the September 2022
Notes was to convert directly into our common equity (or directly into proceeds paid to the holders of our common equity in connection
with the Change of Control) at a price per share that is 60% of the price per share of common equity paid at the Change of Control. Boustead
Securities, LLC acted as the placement agent for the private placement and received as part of its compensation and five-year warrants
to purchase shares of the Company’s common stock at a price equal to the conversion price of the Private Placement Notes in an
amount equal to 6% of the shares of common stock underlying the Private Placement Notes. The Company has determined that the warrants
issued to the placement agent receive equity treatment. The warrants were recorded at fair value at issuance and recorded as debt issuance
costs associated with the Boustead Private Placement Notes.
The
Company has determined the redemption features in the Private Placement Notes contained rights and obligations for conversion contingent
upon a potential future financing event or a change in control, and that such features were required to be bifurcated from the host debt
instrument and accounted for as a derivative liability to be remeasured at the end of each reporting period.
The
Company evaluated whether the July, August, and September 2022 Notes contained embedded features that meet the definition of derivatives
under FASB ASC 815, Derivatives and Hedging. The Company determined that these redemption features contained rights and obligations
for conversion contingent upon a potential future financing event or a change in control. Thus, the embedded put options were bifurcated
from the face value of the July, August and September Notes and accounted for as derivative liabilities to be remeasured at the end of
each reporting period with the change in the fair value included in other expenses, in the accompanying statements of operations and
comprehensive loss. The fair value of the put option derivative liabilities at issuance was $339,934, with the offsetting amount being
recorded as a debt discount. The debt discount was being amortized to interest expense using the effective interest method over the expected
term of the July, August and September 2022 Notes. The effective interest rates of the July, August and September 2022 Notes
were 36.3%, 26.1%, and 28.8%, respectively, compared to a stated interest rate of 6.0%.
Non-Convertible
Promissory Note
On
November 30, 2022, the Company closed a $250,000 note offering (the “November Private Placement”) pursuant to which the Company
sold to two accredited investors units consisting of (i) notes in the aggregate principal amount of $250,000, which bore interest at
the rate of 10%, repayable at the earlier of the time of the completion of the IPO or November 30, 2023 (the “November Notes”)
and (ii) warrants to purchase up to an aggregate of 250,000 shares of common stock exercisable at $1.00 per common share, which were
exercisable at any time and were automatically exercised into shares of the Company’s common stock upon the consummation of the
IPO (the “November Warrants”). At the time the November Notes and November Warrants were sold, it was intended that the principal
amount of the November Notes would be repaid upon the consummation of the IPO out of the proceeds of the November Warrants exercise.
The
issuance of the November Warrants triggered an adjustment to the conversion price of the Private Placement Notes (the July 2022, August
2022 and September 2022 Notes) to $1.00 per share, pursuant to down-round protection included in those notes. As a result of the adjustment
of the conversion price of the Private Placement Notes, the five-year warrants issued to Boustead Securities, LLC in connection with
the Private Placement, were amended to provide for the purchase of an aggregate of 11,500 shares of the Company’s common stock
at an exercise price equal to 60% of the initial public offering price per share.
The
Company also issued 15,000 warrants to Boustead for the placement of the November financing. The November placement agent warrants have
an exercise price of $1.00 per common share.
In
December 2022, the Company entered into amendments to the March 2022 Note and the June 2022 Note to adjust the conversion price of the
March 2022 Note and the June 2022 Note to $1.00 per common share. The March 2022 Note and June 2022 Note originally had a conversion
price equal to 80% and 60%, respectively, of the IPO price. While this amendment was not required, as the March 2022 Note and June 2022
did not have down-round protection like the Private Placement Notes, the amendment was entered into to provide the investors in the March
and June Notes with the same conversion price as the Private Placement Notes.
The
Company incurred debt issuance costs attributed to the November Notes, which were recorded as a debt discount.
January
2023 Settlement of Debt
On
January 24, 2023, concurrent with the consummation of the IPO, the Company issued 1,140,700 shares of common stock upon conversion of
the convertible promissory notes. All convertible notes and related accrued interest were settled in full on January 24, 2023.
On
January 24, 2023, the Company issued 250,000 shares of common stock upon the exercise of the November Warrants. The $250,000 of proceeds
of the warrant exercise were used to concurrently pay off the $250,000 November Notes. All of the November Notes were settled in full
on January 24, 2023.
Upon
pay-off and settlement of the convertible promissory notes and November Notes, the Company had $740,139 of unamortized debt discount
costs remaining on the balance sheet. During the three months ended March 31, 2023, the Company recorded a $740,139 loss on the extinguishment
of debt for the unamortized debt issuance costs.
Note 7.
Related Party Transactions
On
January 25, 2022, the Company into an agreement with Phamace, LLC, a consulting firm of which Quang Pham, the Company’s Chief
Executive Officer, is the sole member, for an initial term of January 25, 2022 through February 28, 2022. Pursuant to the agreement,
the Company shall pay the sum of $115,000 to Phamace, LLC for advisory and administrative services rendered relating to preparing the
Company to launch as an operating company, which was due and payable on September 30, 2022. The Company settled this obligation
in January 2023.
On
January 25, 2022, the Company issued 7,500,000 shares of common stock, pursuant to a subscription agreement, to Quang Pham, the
Company’s Chief Executive Officer, of which 3,000,000 were subsequently transferred to a related trust, of which Mr. Pham’s
child is a beneficiary and Mr. Pham is the trustee with sole voting and disposition power with respect to the shares owned by the
trust, 1,100,000 were subsequently transferred to friends, family and a trust of which Mr. Pham’s child is a beneficiary, but of
which Mr. Pham has no voting or disposition power, and 125,000 were transferred to non-profit organizations. Mr. Pham paid a total
of $7,500 for such founders shares.
On
March 1, 2022, the Company issued a convertible promissory note in the amount of $500,000 to John Murphy, a member of the Company’s
board of directors, which bears interest at 5% and matures on March 1, 2025. The note, as amended in December 2022, converted into
514,792 shares of the Company’s common Stock at a conversion price equal to $1.00 upon consummation of the initial public offering.
See Note 6 for further discussion.
On
May 17, 2022, the Company issued 450,000 shares of restricted common stock, pursuant to a restricted stock purchase agreement, to
Matthew Szot its Chief Financial Officer, which shares shall vest quarterly over a period of two years, subject to certain adjustments,
as provided in the Restricted Stock Purchase Agreement dated May 17, 2022.
On
August 22, 2022, the Company issued a convertible promissory note in the amount of $50,000 to Glynn Wilson, a member of the Company’s
board of directors, which bears interest at 6% and matures on September 13, 2025. The note was converted into 50,000 shares of the Company’s
common Stock at a conversion price equal to $1.00 upon consummation of the initial public offering. See Note 6 for further discussion.
Note 8.
Leases, Commitments, and Contingencies
Leases
At
lease inception, the Company determines if an arrangement is an operating or capital lease. For operating leases, the Company recognized
rent expense, inclusive of rent escalation, on a straight-line basis over the lease term.
In
accordance with ASC 842, Leases, the Company determines if an arrangement is or contains a lease at inception. A contract is or contains
a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration.
The Company classifies leases at the lease commencement date as operating or finance leases and records a right-of-use asset and a lease
liability on the balance sheet for all leases with an initial lease term of greater than 12 months. Leases with an initial term of 12
months or less are not recorded in the balance sheet, but payments are recognized as expenses on a straight-line basis over the lease
term. The Company has elected not to recognize leases with terms of 12 months or less.
A
lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of
ownership of the leased asset to the Company by the end of the lease term, (ii) the Company holds an option to purchase the leased asset
that it is reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset,
(iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, or (v)
the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of
the lease term. All other leases are recorded as operating leases.
The
Company enters into contracts that contain both lease and non-lease components. Non-lease components may include maintenance, utilities,
and other operating costs. The Company combines the lease and non-lease components of fixed costs in its lease arrangements as a single
lease component. Variable costs, such as utilities or maintenance costs, are not included in the measurement of right-of-use assets and
lease liabilities but rather are expensed when the event determining the amount of variable consideration to be paid occurs.
Finance
and operating lease assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments
over the lease term using the discount rate implicit in the lease. If the rate implicit is not readily determinable, the Company utilizes
an estimate of its incremental borrowing rate based upon the available information at the lease commencement date. Operating lease assets
are further adjusted for prepaid or accrued lease payments. Operating lease payments are expensed using the straight-line method as an
operating expense over the lease term.
The
Company’s operating lease ROU assets and liabilities as of March 31, 2023 and December 31, 2022 are as follows:
| |
March 31, 2023 | | |
December 31, 2022 | |
Assets | |
| | |
| |
Operating lease ROU assets | |
$ | 38,180 | | |
$ | 43,578 | |
Liabilities | |
| | | |
| | |
Current | |
| | | |
| | |
Operating lease liabilities | |
$ | 23,162 | | |
$ | 22,288 | |
Noncurrent | |
| | | |
| | |
Operating lease liabilities | |
| 15,167 | | |
| 21,350 | |
Total operating lease liabilities | |
$ | 38,329 | | |
$ | 43,638 | |
Operating
lease expense was $6,636 for the three months ended March 31, 2023. Cash paid for amounts included in the measurement of operating
lease liabilities included in operating cash flows was $6,501 for the three months ended March 31, 2023. The remaining operating
lease term was 19 months, and the operating lease discount rate was 12% as of March 31, 2023.
Future
annual lease payments under non-cancellable operating leases as of March 31, 2023 were as follows:
2023 | |
$ | 19,567 | |
2024 | |
| 22,319 | |
Total lease payments | |
| 41,886 | |
Less: Imputed interest | |
| 3,557 | |
Total operating lease liabilities | |
$ | 38,329 | |
Contingencies
In
the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties
and provide for general indemnifications. The Company’s exposure under these agreements is unknown, because it involves claims
that may be made against the Company in the future, but have not yet been made. The Company accrues a liability for such matters when
it is probable that future expenditures will be made and such expenditures can be reasonably estimated.
Indemnification
In
accordance with the Company’s certificate of incorporation and bylaws, the Company indemnifies its officers and directors for certain
events or occurrences, subject to certain limits, while they are serving in such capacity. In addition, the Company has entered into
indemnification agreements with its officers and directors. There have been no claims to date, and the Company has a directors and officers
liability insurance policy that may enable it to recover a portion of any amounts paid for future claims.
Note 9.
Stockholders’ Equity and Warrants
Common
Stock
Pursuant
to the Certificate of Incorporation filed on January 25, 2022, the Company was authorized to issue a total of 10,000,000 shares
of common stock with a par value of $0.001 per share. On December 5, 2022, the Company filed an Amended and Restated Certificate of Incorporation
to increase the authorized capital stock of the Company to 82,500,000 shares, consisting of 75,000,000 shares of common stock, par value
$0.001 per share, and 7,500,000 shares of preferred stock, par value $0.001 per share, which was approved by the Company’s Board
of Directors, as well as a majority of the Company’s shareholders, on December 5, 2022.
Holders
of common stock are entitled to one vote for each share of common stock held of record for the election of the Company’s directors
and all other matters requiring stockholder action. Holders of common stock will be entitled to receive such dividends, if any, as may
be declared from time to time by the Company’s Board in its discretion out of funds legally available therefor.
On
January 24, 2023, the Company consummated its initial public offering (the “IPO”) of 1,400,000 shares of its common stock
at a public offering price of $5.00 per share, generating gross proceeds of $7,000,000 and net proceeds of $5,408,575. The Company’s
shares of common stock commenced trading on the Nasdaq Capital Market on January 20, 2023, under the symbol “CVKD.”
In
connection with the IPO, on January 19, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”)
with Boustead Securities, LLC, as representative of the underwriters (the “Representative”). Pursuant to the Underwriting
Agreement, the Company agreed to issue to the underwriters a five-year warrant (the “Representative’s Warrant”) to
purchase an aggregate of 84,000 shares of the Company’s common stock, which is equal to six percent (6%) of the shares of
common stock sold in the IPO. Such Representative’s Warrant has an exercise price of $6.00, which is equal to 120% of the public
offering price of the common stock in the IPO.
Warrants
The
following table summarizes the total warrants outstanding at March 31, 2023:
| |
Issue Date | |
Exercise Price
Per Share | | |
Expiration
Date | |
Outstanding
as of
December 31,
2022 | | |
New
Issuance | | |
Exercised | | |
Outstanding
as of
March 31,
2023 | |
Placement agent warrants | |
July - Sept 2022 | |
$ | 3.00 | | |
July - Sept 2027 | |
| 11,500 | | |
| - | | |
| - | | |
| 11,500 | |
Placement agent warrants | |
Nov 2022 | |
$ | 1.00 | | |
Nov 2027 | |
| 15,000 | | |
| - | | |
| - | | |
| 15,000 | |
Investor warrants | |
Nov 2022 | |
$ | 1.00 | | |
Earlier of IPO or Nov 2027 | |
| 250,000 | | |
| - | | |
| (250,000 | ) | |
| - | |
Representative warrants | |
Jan 2023 | |
$ | 6.00 | | |
Jan 2028 | |
| - | | |
| 84,000 | | |
| - | | |
| 84,000 | |
| |
| |
| | | |
| |
| 276,500 | | |
| 84,000 | | |
| (250,000 | ) | |
| 110,500 | |
Note 10.
Equity-Based Compensation
The Company adopted the Cadrenal Therapeutics,
Inc. 2022 Equity Incentive Plan (the “Initial Plan”), on July 11, 2022, which was later amended and restated on October 16,
2022, for purposes of clarifying the application of certain of the rules of the Initial Plan to awards approved before such amendment
and restatement of the Initial Plan and to facilitate the transition to the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive
Plan (the “Successor Plan”) for the issuance and approval of awards after consummation of the IPO. On October 16, 2022,
the Board adopted and the Company’s stockholders approved the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (the
“2022 Plan”), which is a successor to and continuation of the Initial Plan and became effective on January 19, 2023. Upon
the effectiveness of the 2022 Plan, it replaced the Initial Plan, except with respect to awards outstanding under the Initial Plan, and
no further awards will be available for grant under the Initial Plan.
Subject
to certain adjustments, the maximum number of shares of common stock that could have been issued under the Plans in connection with awards
was 2,000,000 shares, of which 760,000 remained available for issuance as March 31, 2023. The maximum number of shares of common stock
that may be issued under the 2022 Plan will automatically increase on January 1 of each calendar year for a period of ten years
commencing on January 1, 2024 and ending on (and including) January 1, 2033, to a number of shares of common stock equal to
20% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year; provided, however that
the board of directors, or the compensation committee, may act prior to January 1 of a given calendar year to provide that the increase
for such year will be a lesser number of shares of common stock. All available shares may be utilized toward the grant of any type of
award under the 2022 Plan.
The
Company measures its stock-based awards granted to employees, consultants and directors based on the estimated fair values of the awards
and recognizes the compensation over the requisite service period. The Company uses the Black-Scholes option-pricing model to estimate
the fair value of its stock option awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation
expense is based on awards ultimately expected to vest, it is reduced by forfeitures. The Company accounts for forfeitures as they occur.
Weighted
average assumptions used in the Black-Scholes model are set forth below:
| |
| March 31,
2023 | |
Risk-free
interest rate | |
| 2.98% – 4.10% | |
Dividend
yield | |
| — | |
Expected
term (years) | |
| 5.27 – 5.81 | |
Volatility | |
| 62.4% – 62.5% | |
Activity under the Plans for the period from December 31,
2022 to March 31, 2023 is set forth below:
| |
Number
Outstanding | | |
Weighted-Average
Exercise Price Per Share | | |
Weighted-Average
Remaining
Contractual Life
(Years) | | |
Aggregate Intrinsic
Value | |
Outstanding at December 31, 2022 | |
| 1,100,000 | | |
$ | 0.84 | | |
| 9.57 | | |
$ | 4,578,000 | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Canceled/forfeited/expired | |
| - | | |
| - | | |
| - | | |
| - | |
Outstanding at March 31, 2023 | |
| 1,100,000 | | |
$ | 0.84 | | |
| 9.33 | | |
$ | 808,500 | |
Options vested and exercisable at March 31, 2023 | |
| 183,328 | | |
$ | 0.64 | | |
| 9.31 | | |
$ | 84,002 | |
Options vested and expected to vest as of March 31, 2023 | |
| 1,100,000 | | |
$ | 0.84 | | |
| 9.33 | | |
$ | 808,500 | |
The
weighted average grant date fair value of options granted to date was $1.11. At March 31, 2023, the Company had $935,190 of unrecognized
stock-based compensation expense related to stock options which will be recognized over the weighted average remaining requisite service
period of 2.0 years. The Company settles employee stock option exercises with newly issued shares of common stock.
On
January 24, 2023, the Company granted 50,000 shares of the Company’s common stock to the Company’s Chief Financial Officer.
The shares were fully vested on the date of grant.
On March 30, 2023, the Company issued 10,839 shares
of its common stock to a consultant for services rendered.
On March 31, 2023, the Company issued 77,340 shares
of its common stock for services to be performed from April through September 2023.
Total
stock-based compensation expense and the allocation of stock-based compensation for the periods presented below were as follows:
| |
Three Months Ended March 31, 2023 | | |
January 25, 2022 (Inception) to March 31, 2022 | |
General and administrative | |
$ | 194,140 | | |
$ | - | |
Research and development | |
| 92,256 | | |
| - | |
Total stock-based compensation | |
$ | 286,396 | | |
$ | - | |
Note 11.
Net Loss Per Share
The
following table sets forth the computation of the basic and diluted net loss per common share:
| |
Three Months Ended March 31, 2023 | | |
January 25, 2022 (Inception) to March 31, 2022 | |
| |
| | |
| |
Numerator: | |
| | |
| |
Net loss | |
$ | (5,173,574 | ) | |
$ | (176,648 | ) |
Denominator: | |
| | | |
| | |
Weighted average common shares outstanding | |
| 10,772,493 | | |
| 7,500,000 | |
Net loss per share, basic and diluted | |
$ | (0.48 | ) | |
$ | (0.02 | ) |
Since
the Company was in a loss position for the periods presented, basic net loss per share is the same as diluted net loss per share as the
inclusion of all potential dilutive securities would have been anti-dilutive. For the periods presented, there were no potential dilutive
securities other than the convertible notes, stock options, and warrants.
Note 12.
Subsequent Events
The
Company has evaluated events that occurred through May 9, 2023, the date that the financial statements were issued and determined
that there have been no events that have occurred that would require adjustments to our disclosures in the financial statements.
8,850,001 Shares of Common
Stock
Cadrenal Therapeutics, Inc.
, 2023
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 13. Other Expenses of Issuance
and Distribution
The following table sets forth the expenses to
be incurred in connection with the offering described in this Registration Statement, other than underwriting discounts and commissions,
all of which will be paid by us. All amounts are estimates except the SEC’s registration fee and the Financial Industry Regulatory
Authority, Inc.’s filing fee.
|
|
Amount to
be Paid |
|
SEC Registration Fee |
|
$ |
1,500 |
|
Legal fees and expenses |
|
|
120,000 |
|
Accounting fees and expenses |
|
|
10,000 |
|
Miscellaneous expenses |
|
|
170,000 |
|
Total |
|
$ |
301,500 |
|
Item 14. Indemnification of Directors
and Officers
Section 145 of the Delaware General Corporation
Law empowers a corporation to indemnify its directors and officers and to purchase insurance with respect to liability arising out of
their capacity or status as directors and officers, provided that the person acted in good faith and in a manner the person reasonably
believed to be in our best interests, and, with respect to any criminal action, had no reasonable cause to believe the person’s
actions were unlawful. The Delaware General Corporation Law further provides that the indemnification permitted thereunder shall not be
deemed exclusive of any other rights to which the directors and officers may be entitled under the corporation’s bylaws, any agreement,
a vote of stockholders or otherwise. The certificate of incorporation of the registrant provides for the indemnification of the registrant’s
directors and officers to the fullest extent permitted under the Delaware General Corporation Law. In addition, the bylaws of the registrant
require the registrant to fully indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending
or completed action, suit or proceeding (whether civil, criminal, administrative or investigative) by reason of the fact that such person
is or was a director or officer of the registrant, or is or was a director or officer of the registrant serving at the registrant’s
request as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against
expenses (including attorney’s fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person
in connection with such action, suit or proceeding, to the fullest extent permitted by applicable law.
Section 102(b)(7) of the Delaware General
Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally
liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except (i) for any
breach of the director’s duty of loyalty to the corporation or its stockholders; (ii) for acts or omissions not in good faith
or which involve intentional misconduct or a knowing violation of law; (iii) for payments of unlawful dividends or unlawful stock
repurchases or redemptions; or (iv) for any transaction from which the director derived an improper personal benefit. The registrant’s
certificate of incorporation provides that the registrant’s directors shall not be personally liable to it or its stockholders for
monetary damages for breach of fiduciary duty as a director and that if the Delaware General Corporation Law is amended to authorize corporate
action further eliminating or limiting the personal liability of directors, then the liability of the registrant’s directors shall
be eliminated or limited to the fullest extent permitted by the Delaware General Corporation Law, as so amended.
As permitted by the Delaware General Corporation
Law, the registrant intends to enter into separate indemnification agreements with each of the registrant’s directors and certain
of the registrant’s officers which require the registrant, among other things, to indemnify them against certain liabilities which
may arise by reason of their status as directors, officers or certain other employees.
The registrant expects to obtain and maintain
insurance policies under which its directors and officers are insured, within the limits and subject to the limitations of those policies,
against certain expenses in connection with the defense of, and certain liabilities which might be imposed as a result of, actions, suits
or proceedings to which they are parties by reason of being or having been directors or officers. The coverage provided by these policies
may apply whether or not the registrant would have the power to indemnify such person against such liability under the provisions of the
Delaware General Corporation Law.
These indemnification provisions and the indemnification
agreements entered into between the registrant and the registrant’s officers and directors may be sufficiently broad to permit indemnification
of the registrant’s officers and directors for liabilities (including reimbursement of expenses incurred) arising under the Securities
Act.
Item 15. Recent Sales of Unregistered
Securities
Since January 25, 2022, the Company has not
issued unregistered securities to any person, except as described below. None of these transactions involved any underwriters, underwriting
discounts or commissions, except as specified below, or any public offering, and, unless otherwise indicated below, the Company believes
that each transaction was exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof
and/or Rule 506 of Regulation D promulgated thereunder, and/or Regulation S promulgated thereunder regarding offshore offers
and sales. All recipients had adequate access, though their relationships with the Company, to information about the Company.
Original Issuance of Stock
On January 25, 2022, the Company issued 7,500,000 shares
of Common Stock, pursuant to a subscription agreement, to Quang Pham, our Chief Executive Officer, of which 4,500,000 were subsequently
transferred to related trusts, of which Mr. Pham’s child is a beneficiary and Mr. Pham is the trustee with sole voting
and disposition power with respect to the shares owned by the Trusts. Mr. Pham paid a total of $7,500 for such founders shares.
On May 17, 2022, the Company issued 450,000 shares
of restricted Common Stock, pursuant to a restricted stock purchase agreement, to Matthew Szot, our Chief Financial Officer, which shares
shall vest quarterly over a period of two (2) years, subject to certain adjustments, as provided in the Restricted Stock Purchase Agreement
dated May 17, 2022.
On July 11, 2022, the Company issued a restricted
stock grant of 46,875 shares of Common Stock to a consultant, which fully vested on October 1, 2022.
On July 11, 2022, the Company granted stock
options to purchase 650,000 shares of Common Stock at an exercise price of $0.64 per common share. The stock option grants were issued
to directors, members of the Scientific Advisory Board, and other consultants to the Company and vest in periods ranging over one to three
years.
On August 18, 2022, the Company issued stock
options to purchase 300,000 shares of Common Stock to Douglas Losordo, our Chief Medical Officer. The options have an exercise price
of $0.64 per common share and will vest quarterly over a period of three (3) years, subject to certain adjustments.
On August 18, 2022, the Company issued 40,000 shares
of Common Stock to a consultant.
On August 18, 2022, the Company issued 40,000 shares
of Common Stock to a director nominee.
On August 18, 2022, the Company issued stock
options to purchase an aggregate of 100,000 shares of Common Stock to members of the Scientific Advisory Board. The options have
an at an exercise price of $0.64 per common share and will vest over a period of three (3) years, with 33.33% vesting on the first anniversary
of the effective date and thereafter 1/36 on a monthly basis.
On September 16, 2022, we issued 50,000 shares
of Common Stock to John Murphy, a director nominee.
On October 3, 2022, the Company issued stock
grants totaling 137,000 shares of Common Stock to various consultants for services. These shares were fully vested upon the date
of grant. 70,000 of the shares were subsequently returned and cancelled.
On October 3, 2022, the Company issued stock
options to purchase 50,000 shares of Common Stock to a director nominee. The options have an exercise price of $5.00 per common share
and will vest over a three-year period, with 33.33% vesting on the first anniversary of the effective date, and thereafter 1/36 on
a monthly basis.
On January
19, 2023, the Company issued 600,000 shares of Common Stock to HESP LLC, pursuant to the terms an Amendment to the Asset Purchase Agreement,
dated as of August 18, 2022, between the Company and HESP LLC.
On January
24, 2023, concurrently with the consummation of the Company’s initial public offering, the Company issued the following securities:
(i) 1,140,700 shares of Common Stock upon conversion of certain convertible promissory notes; and (ii) 250,000 shares of Common Stock
upon the exercise of certain outstanding warrants. The shares of Common Stock issued upon conversion of the convertible promissory notes
were issued in reliance on the exemption from the registration requirements of the Securities Act pursuant to Section 3(a)(9) as
they were issued to existing security holders for no additional consideration.
On March 30, 2023, the
Company issued 10,839 shares of our Common Stock to a consultant for services rendered.
On March 31, 2023, the
Company issued 77,340 shares of our Common Stock to a consultant for services to be performed from April through September 2023.
Convertible Promissory Notes and Related
Warrants
On March 1, 2022, we issued a convertible
promissory note in the amount of $500,000 (the “March 2022 Note”). The March 2022 Note bears interest at 5% and
matures on March 1, 2025 (“March Note Maturity Date”). The principal amount due under the March 2022 Note (and,
at the Company’s option, any accrued but unpaid interest under the March 2022 Note) will be automatically converted, on or
before the March Note Maturity Date, into equity securities issued and sold at the initial closing of our next equity financing (“Next
Equity Securities”) in a single transaction or a series of related transactions yielding gross proceeds to us of at least $3,000,000
(the “Next Equity Financing”). The March 2022 Note was initially convertible into shares of Common Stock at a conversion
price equal to the quotient obtained by dividing (i) the entire principal amount of the March 2022 Note plus (if applicable)
any accrued but unpaid interest under the March 2022 Note by (ii) eighty percent (80%) of the price per share of the Next Equity
Securities sold in the Next Equity Financing. In the event of a Change of Control which occurs prior to repayment in full of the March 2022
Note, immediately prior to the Change of Control, the outstanding principal and any accrued but unpaid interest on the March 2022
Note will convert directly into our common equity (or directly into proceeds paid to the holders of our common equity in connection with
the Change of Control) at a price per share that is 80% of the price per share of common equity paid at the Change of Control. In December
2022 we amended the conversion price of the March 2022 Note to $1.00 per share.
On June 13, 2022, we issued a convertible
promissory note in the amount of $50,000 (the “June 2022 Note”). The June 2022 Note bears interest at 6% and matures
on June 13, 2025 (“June Note Maturity Date”). The principal amount due under the June 2022 Note (and, at the Company’s
option, any accrued but unpaid interest under the June 2022 Note) will be automatically converted, on or before the June Note Maturity
Date, into Next Equity Securities in the Next Equity Financing. The June 2022 Note was initially convertible into shares of Common
Stock at a conversion price equal to the quotient obtained by dividing (i) the entire principal amount of the June 2022 Note
plus (if applicable) any accrued but unpaid interest under the June 2022 Note by (ii) sixty percent (60%) of the price per share
of the Next Equity Securities sold in the Next Equity Financing. In the event of a Change of Control which occurs prior to repayment in
full of the June 2022 Note, immediately prior to the Change of Control, the outstanding principal and any accrued but unpaid interest
on the June 2022 Note will convert directly into our common equity (or directly into proceeds paid to the holders of our common equity
in connection with the Change of Control) at a price per share that is 60% of the price per share of common equity paid at the Change
of Control. In December 2022 we amended the conversion price of the June 2022 Note to $1.00 per share.
The March 2022 Note and the June 2022
Note (collectively, the “Notes”) may be prepaid at any time without penalty. For the purposes of the Notes, the term “Change
of Control” means (i) a sale of all or substantially all of our assets other than to an Excluded Entity (as defined), (ii) a
merger, consolidation or other capital reorganization or business combination transaction of us with or into another corporation, limited
liability company or other entity other than an Excluded Entity, or (iii) the consummation of a transaction, or series of related
transactions, in which any “person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act)
becomes the “beneficial owner” (as defined in Rule 13d-3 of the Exchange Act), directly or indirectly, of all
of our then outstanding voting securities.
On July 16, 2022, we closed the first tranche
of a private placement (the “Private Placement”) pursuant to which we issued convertible promissory notes in the aggregate
principal amount of $450,000 (the “First Tranche Private Placement Notes”) and received gross proceeds of $450,000. The private
placement offering was for up to $2,000,000 of convertible promissory notes and was to terminate upon the sale of all $2,000,000 of convertible
promissory notes or July 31, 2022 subject to extension until August 31, 2022, in the sole discretion of the placement agent
and us. We, together with the placement agent, determined to extend the Private Placement to August 31, 2022. On August 22,
2022, we issued a convertible promissory note pursuant to the Private Placement in the principal amount of $50,000 (the “Second
Tranche Private Placement Note”) and received gross proceeds of $50,000. The Private Placement was further extended to September 30,
2022, after obtaining the consent of the investors in the Private Placement to date. On September 13, 2022, we issued convertible
promissory notes in the aggregate principal amount of $75,000 (together with the First Tranche Private Placement Notes, and the Second
Tranche Private Placement Note the “Private Placement Notes”) and received gross proceeds of $75,000. The Private Placement
Notes bear interest at 6% and mature on the third anniversary of the last closing of the Private Placement Notes, i.e. September 13,
2025. The principal amount due under the Private Placement Notes (and, at our option, any accrued but unpaid interest under the Private
Placement Notes) will be automatically converted into shares of our Common Stock upon the consummation of this offering. The Private Placement
Notes were initially convertible into shares of Common Stock at a conversion price equal to the quotient obtained by dividing (i) the
entire principal amount of the Private Placement Notes plus (if applicable) any accrued but unpaid interest under the Private Placement
Notes by (ii) sixty percent (60%) of the initial offering price per share subject to adjustment in the event of a subsequent issuance
of securities by us at a price per share less than the conversion price. Upon the issuance of the November Notes and November Warrants
the conversion price was reduced to $1.00 per share. Boustead Securities, LLC acted as the placement agent for the private placement and
received as part of its compensation and five-year warrants, as amended, to purchase an aggregate of 11,500 shares of our Common
Stock at an exercise price equal to 60% of the initial public offering price per share.
Non-Convertible Promissory Notes and Related
Warrants
On November 30, 2022, we closed a $250,000
note offering (the “November Private Placement”) pursuant to which we sold to two accredited investors units consisting of
(i) notes in the aggregate principal amount of $250,000, which bear interest at the rate of 10%, repayable at the time of the completion
of this offering (the “November Notes”) and(ii) warrants to purchase up to an aggregate of 250,000 shares of Common Stock
exercisable at $1.00 per share which are automatically exercisable into shares of our Common Stock upon the consummation of this offering
(the “November Warrants”). The principal amount of the November Notes will be repaid upon the consummation of this offering
out of the proceeds of the automatic exercise of the November Warrants, with any interest owed on the November Notes to be payable in
cash.
Boustead Securities, LLC acted as the placement
agent for the November Private Placement and received a commission equal to 7% of the gross proceeds received by us from the sale of the
November Notes, a non-accountable expense allowance equal to 1% of the gross proceeds received by us from the sale of the November
Notes and five-year warrants to purchase shares of our Common Stock in an amount equal to 6% of the shares of Common Stock underlying
the securities issued in the November Private Placement at an exercise price of $1.00 per share.
July 2023 Private Placement
On July 14, 2023, we issued and sold 1,300,000
shares of Common Stock, Pre-Funded Warrants to purchase 2,985,715 shares of Common Stock and Common Warrants to purchase 4,285,715 shares
of Common Stock to one institutional investor for gross proceeds of $7,500,001.25. The Common Warrants are immediately exercisable for
five and one-half (5.5) years and have an exercise price of $1.75. The Pre-Funded Warrants have an exercise price of $0.0001 and do not
expire until exercised in full.
In connection with the Private Placement, we issued
warrants (the “Placement Agent Warrants”) to purchase an aggregate of 278,571 shares of Common Stock to the placement
agent, which is equal to 6.5% of the shares of Common Stock sold in the Private Placement. The Placement Agent Warrants are immediately
exercisable for five and one-half (5.5) years and have an exercise price of $2.1875, which is equal to 125% of the offering price of the
Shares and accompanying Common Warrants sold in the Private Placement.
Item 16. Exhibit and Financial Statement
Schedules
(a) Exhibits.
The exhibit index attached hereto is incorporated
herein by reference.
(b) Financial Statement Schedules.
(a)
Exhibits. See the Exhibit Index immediately preceding the signature pages hereto, which is incorporated by reference as if fully
set forth herein.
Item 17. Undertakings
The undersigned Registrant hereby undertakes:
To file, during any period in which offers or
sales are being made, a post-effective amendment to this Registration Statement:
(i) to include
any prospectus required by Section 10(a)(3) of the Securities Act;
(ii) to reflect
in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered and any deviation from the low or high
end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b)
if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price
set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii) to include
any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material
change to such information in the registration statement;
provided, however, that paragraphs
(i), (ii) and (iii) do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained
in reports filed with or furnished to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Exchange Act that
are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that
is part of the registration statement.
That, for the purpose of determining any liability
under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
To remove from registration by means of a post-effective
amendment any of the securities being registered which remain unsold at the termination of the offering.
That, for the purpose of determining liability
under the Securities Act to any purchaser:
(A) Each prospectus
filed by a Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus
was deemed part of and included in the registration statement; and
(B) Each prospectus
required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating
to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a)
of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form
of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the
prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date
shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which
that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering
thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is
part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or
modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in
any such document immediately prior to such effective date.
That, for purposes of determining any liability
under the Securities Act, each filing of Registrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and,
where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is
incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising
under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions,
or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed
in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other
than the payment by a Registrant of expenses incurred or paid by a director, officer or controlling person of a Registrant in the successful
defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities
being registered, that Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit
to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities
Act and will be governed by the final adjudication of such issue.
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933, as amended, the registrant has duly caused this registration statement on Form S-1 to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Ponte Vedra, State of Florida, on the 24th day of July, 2023.
|
CADRENAL THERAPEUTICS, INC. |
|
|
|
|
By: |
/s/ Quang Pham |
|
Name: |
Quang Pham |
|
Title: |
President and Chief Executive Officer |
|
|
(Principal Executive Officer) |
POWER OF ATTORNEY
KNOW ALL BY THESE PRESENTS that each individual
whose signature appears below constitutes and appoints Quang Pham and Matthew Szot our true and lawful attorneys and agents with full
power of substitution and resubstitution, with full power to sign for us, and in our names in the capacities indicated below, any and
all amendments to this registration statement, any subsequent registration statements pursuant to Rule 462 of the Securities Act of 1933,
as amended, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorney-in-fact and agent, full power and authority to do and perform each and every act and thing
requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person,
hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause
to be done by virtue hereof. This power of attorney may be executed in counterparts.
Pursuant to the requirements of the Securities
Act of 1933, as amended, this registration statement on Form S-1 has been signed by the following persons in the capacities and on the
dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/
Quang Pham |
|
Chairman
of the Board and Chief Executive Officer |
|
July
24, 2023 |
Quang Pham |
|
|
|
|
|
|
|
|
|
/s/
Matthew Szot |
|
Chief Financial Officer
(Principal Financial Officer |
|
July
24, 2023 |
Matthew Szot |
|
and
Principal Accounting Officer) |
|
|
|
|
|
|
|
/s/
Robert Lisicki |
|
Director |
|
July
24, 2023 |
Robert
Lisicki |
|
|
|
|
|
|
|
|
|
/s/
John R. Murphy |
|
Director |
|
July
24, 2023 |
John R. Murphy |
|
|
|
|
|
|
|
|
|
/s/
Glynn Wilson |
|
Director |
|
July
24, 2023 |
Glynn Wilson |
|
|
|
|
|
|
|
|
|
/s/
Steven Zelenkofske |
|
Director |
|
July
24, 2023 |
Steven Zelenkofske |
|
|
|
|
EXHIBIT INDEX
Exhibit No. |
|
Description |
|
|
|
1.1 |
|
Underwriting Agreement, dated January 19, 2023, by and between Cadrenal Therapeutics, Inc. and Boustead Securities, LLC, as representative of the underwriters (Incorporated by reference as Exhibit 1.1 to the Current Report on Form 8-K (001-41596), as filed with the SEC on January 25, 2023) |
3.1 |
|
Amended and Restated Certificate of Incorporation (Incorporated by reference as Exhibit 3.1 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022) |
3.2 |
|
Amended and Restated Bylaws (Incorporated by reference as Exhibit 3.2 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022) |
4.1 |
|
Specimen Common Stock Certificate (Incorporated by reference as Exhibit 4.1 to the Registration Statement on Form S-1 (333-267562) filed on October 7, 2022) |
4.2# |
|
Convertible Promissory Note dated March 1, 2022 issued to John Murphy (Incorporated by reference as Exhibit 4.3 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
4.3 |
|
Form of Convertible Note dated June 13, 2022 (Incorporated by reference as Exhibit 4.4 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
4.4 |
|
Form of Private Placement Convertible Note (Incorporated by reference as Exhibit 4.5 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
4.5 |
|
Form of November Private Placement Promissory Note (Incorporated by reference as Exhibit 4.6 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022) |
4.6 |
|
Form of Amended and Restated November Warrant (Incorporated by reference as Exhibit 4.7 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022) |
4.7 |
|
Form of Amended and Restated Placement Agent Warrant from Private Placement (Incorporated by reference as Exhibit 4.8 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022) |
4.8 |
|
Form of Placement Agent Warrant from November Private Placement (Incorporated by reference as Exhibit 4.9 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022) |
4.9 |
|
Form of Amendment to Convertible Promissory Note (Incorporated by reference as Exhibit 4.10 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022) |
4.10 |
|
Representative’s Warrant issued to Boustead Securities, LLC dated January 19, 2023 (Incorporated by reference as Exhibit 4.1 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023) |
4.11 |
|
Description of Securities (Incorporated by reference as Exhibit 4.11 to the Annual Report on Form 10-K (001-41596) filed with the SEC on March 30, 2023) |
4.12 |
|
Form of Pre-Funded Warrant (Incorporated herein by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K (001-41596), as filed with the SEC on July 14, 2023) |
4.13 |
|
Form of Common Stock Warrant (Incorporated herein by reference to Exhibit 4.2 of the Registrant’s Current Report on Form 8-K (001-41596), as filed with the SEC on July 14, 2023) |
4.14 |
|
Form of Placement Agent Warrant (Incorporated herein by reference to Exhibit 4.3 of the Registrant’s Current Report on Form 8-K (001-41596), as filed with the SEC on July 14, 2023) |
5.1* |
|
Opinion of Blank Rome LLP |
10.1# |
|
Cadrenal Therapeutics, Inc. 2022 Equity Incentive Plan and form of Incentive Stock Option Agreement, Non-Qualified Stock Option Agreement for Officers and Other Employees, Non-Qualified Stock Option Agreement for Directors and Consultants, Restricted Stock Agreement, and Restricted Stock Unit Agreement (Incorporated by reference as Exhibit 10.1 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
10.2# |
|
Consulting Agreement, dated January 25, 2022, with Phamace LLC (Quang Pham) from company formation until initiation of payroll (Incorporated by reference as Exhibit 10.2 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
10.3# |
|
Employment Agreement, dated March 1, 2022 with Quang Pham (Incorporated by reference as Exhibit 10.3 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
10.4# |
|
Restricted Stock Purchase Agreement with Matthew Szot (Incorporated by reference as Exhibit 10.5 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
10.5 |
|
Asset Purchase Agreement dated as of April 1, 2022, between Cadrenal Therapeutics, Inc. and HESP LLC (Incorporated by reference as Exhibit 10.7 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
10.6 |
|
Patent Assignment Agreement dated as of April 1, 2022, between Cadrenal Therapeutics, Inc. and HESP LLC (Incorporated by reference as Exhibit 10.8 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
10.7 |
|
Subscription Agreement with Quang Pham, dated January 25, 2022 (Incorporated by reference as Exhibit 10.9 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
10.8 |
|
Form of Investor Rights and Lockup Agreement (Incorporated by reference as Exhibit 10.10 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022) |
10.9+ |
|
License, Development and Commercialization Agreement Effective as of September 16, 2015 by and between Armetheon, Inc. and China Cardiovascular Focus Ltd. (Incorporated by reference as Exhibit 10.13 to the Registration Statement on Form S-1 (333-267562) filed on October 11, 2022) |
10.10# |
|
Cadrenal Therapeutics, Inc. 2022 Amended and Restated Equity Incentive Plan (Incorporated by reference as Exhibit 10.14 to the Registration Statement on Form S-1 (333-267562) filed on October 17, 2022) |
10.11# |
|
Form of Stock Option Grant Notice, Stock Option Agreement and Notice of Exercise under the 2022 Amended and Restated Equity Incentive Plan (Incorporated by reference as Exhibit 10.15 to the Registration Statement on Form S-1 (333-267562) filed on October 17, 2022) |
10.12# |
|
Form of Indemnification Agreement (Incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023) |
10.13 |
|
Amendment to Asset Purchase Agreement, dated as of August 18, 2022, between Cadrenal Therapeutics, Inc. and HESP LLC (Incorporated by reference as Exhibit 10.2 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023) |
10.14# |
|
Employment Agreement with Matthew Szot (Incorporated by reference as Exhibit 10.3 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023) |
10.15# |
|
Employment Agreement with Douglas Losordo (Incorporated by reference as Exhibit 10.4 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023) |
10.16# |
|
Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (Incorporated by reference as Exhibit 10.5 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023) |
10.17# |
|
Form of Stock Option Grant Notice, Stock Option Agreement and Notice of Exercise under the 2022 Successor Equity Incentive Plan (Incorporated by reference as Exhibit 10.6 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023) |
10.18# |
|
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the 2022 Successor Equity Incentive Plan (Incorporated by reference as Exhibit 10.7 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023) |
10.19# |
|
Amendment No. 1 to Employment
Agreement by and between Cadrenal Therapeutics, Inc. and Matthew Szot, dated May 25, 2023 (Incorporated by reference
as Exhibit 10.1 to the Current Report on Form 8-K (001-41596) filed with the SEC on May 26, 2023) |
10.20 |
|
Form of Securities Purchase Agreement (Incorporated herein by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K (001-41596), as filed with the SEC on July 14, 2023) |
10.21 |
|
Form of Registration Rights Agreement (Incorporated herein by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K (001-41596), as filed with the SEC on July 14, 2023) |
|
|
Form of Lock-Up Agreement (Incorporated herein by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K (001-41596), as filed with the SEC on July 14, 2023) |
21.1 |
|
Subsidiaries of Registrant (Incorporated by reference as Exhibit 21.1 to the Annual Report on Form 10-K (001-41596) filed with the SEC on March 30, 2023) |
23.1* |
|
Consent of Independent Registered Public Accounting Firm |
23.2* |
|
Consent of Blank Rome LLP (contained in Exhibit 5.1) |
24.1 |
|
Power of Attorney (included on the signature page of the initial Registration Statement) |
107* |
|
Calculation of Filing Fees Table |
| # | Management
contract or compensatory plan or arrangement. |
| + | Certain
portions of this exhibit indicated therein by [***] have been omitted in accordance with Item 601(b)(10) of Regulation S-K. |
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Cadrenal Therapeutics, Inc.
This opinion is furnished
to you in connection with a Registration Statement on Form S-1 (the “Registration Statement”) filed with the Securities and
Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended (the “Securities Act”), for
the registration of the resale of an aggregate of 8,850,001, shares (the “Securities”) of common stock, par value $0.001 per
share (the “Common Stock”), of Cadrenal Therapeutics, Inc., a Delaware corporation (the “Company”). All of the
Securities are being registered on behalf of certain stockholders of the Company (each a “Selling Stockholder” and collectively,
the “Selling Stockholders”). The Securities consist of (i) 1,300,000 shares of Common Stock purchased by a Selling Stockholder
(the “Investor Selling Stockholder”) in a private placement transaction that closed on July 14, 2023 (the “Private Placement”)
(the “Shares”); (ii) 2,985,715 shares of Common Stock issuable upon the exercise of outstanding pre-funded warrants (the “Pre-Funded
Warrants”) to purchase shares of Common Stock purchased by the Investor Selling Stockholder in the Private Placement (the “Pre-Funded
Warrant Shares”); (iii) 4,285,715 shares of Common Stock issuable upon the exercise of outstanding warrants (the “Common Warrants”)
to purchase shares of Common Stock purchased by the Investor Selling Stockholder in the Private Placement (the “Common Warrant Shares”);
and (iv) 278,571 shares of Common Stock issuable upon the exercise of outstanding warrants issued to designees of H.C. Wainwright &
Co., LLC (“H.C.W.”) in the Private Placement as compensation for acting as placement agent (the “Placement Agent Warrant
Shares”)
As counsel to the Company,
we have examined the Registration Statement, the Pre-Funded Warrants, the Warrants and the Placement Agent Warrants and the originals
or copies, certified or otherwise identified to our satisfaction, of such other documents, corporate records, certificates of public officials
and other instruments as we have deemed necessary for the purposes of rendering this opinion and we are familiar with the proceedings
taken and proposed to be taken by the Company in connection with the filing of the Registration Statement as it relates to the Pre-Funded
Warrant Shares, Common Warrant Shares and Placement Agent Warrant Shares. In our examination, we have assumed the genuineness of all signatures,
the authenticity of all documents submitted to us as originals and the conformity with the originals of all documents submitted to us
as copies.
We have assumed that, at
or prior to the time of the delivery of any of the shares of Common Stock, there will not have occurred any change in the law or the facts
affecting the validity of the shares of Common Stock.
Based upon and subject to
the foregoing, we are of the opinion that (i) the Shares have been duly authorized for issuance and are validly issued, fully paid and
nonassessable, (ii) the Pre-Funded Warrant Shares have been duly authorized for issuance and, when issued, delivered and paid for in accordance
with the terms of the Pre-Funded Warrants, including the payment of the exercise price therefor, will be validly issued, fully paid and
nonassessable, (iii) the Common Warrant Shares have been duly authorized for issuance and, when issued, delivered and paid for in accordance
with the terms of the Warrants, including the payment of the exercise price therefor, will be validly issued, fully paid and nonassessable
and (iv) the Placement Agent Warrant Shares have been duly authorized for issuance and, when issued, delivered and paid for in accordance
with the terms of the Placement Agent Warrants, including the payment of the exercise price therefor, will be validly issued, fully paid
and nonassessable.
We express no opinion as
to matters governed by any laws other than the General Corporation Law of the State of Delaware (including all related provisions of the
Delaware Constitution and all reported judicial decisions interpreting the General Corporation Law of the State of Delaware and the Delaware
Constitution) and the federal laws of the United States of America, as in effect on the date hereof.
We hereby consent to the
filing of this opinion as Exhibit 5.1 to the Registration Statement and to the reference to our firm under the caption “Legal Matters”
in the Registration Statement. In giving our consent, we do not thereby admit that we are in the category of persons whose consent is
required under Section 7 of the Securities Act or the rules and regulations of the Commission thereunder.
We hereby consent to the use in the Prospectus
constituting a part of this Registration Statement on Form S-1 of our report dated March 29, 2023, relating to the financial statements
of Cadrenal Therapeutics, Inc., which is contained in that Prospectus. We also consent to the reference to our Firm under the caption
“Experts” in the Prospectus.
Cadrenal Therapeutics, Inc.