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As
filed with the Securities and Exchange Commission on January 12, 2023
Registration
No. 333-268194
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-1/A
( Amendment
No. 4 )
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
Curative Biotechnology, Inc.
(Exact
name of registrant as specified in its charter)
| Florida |
|
2836 |
|
26-1412177 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(Primary
Standard Industrial
Classification
Code Number) |
|
(I.R.S.
Employer
Identification
Number) |
1825
NW Corporate Blvd, Suite 110
Boca
Raton, FL 33431
(561)
907-8990
(Address,
including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Paracorp
Incorporated
155
Office Plaza Drive, 1st Floor
Tallahassee,
FL 32301
1-800-533-7272
(Name,
address, including zip code, and telephone number, including area code, of agent for service)
Copies
to:
Joseph
M. Lucosky, Esq.
Amit
Hazan, Esq.
Lucosky
Brookman LLP
101
Wood Avenue South
Woodbridge,
NJ 08830
(732) 690-8515
|
|
Anthony
W. Basch, Esq.
J.
Britton Williston, Esq.
Kaufman
& Canoles, P.C.
Two
James Center, 14th Floor
1021
E. Cary St.,
Richmond,
VA 23219
(804)
771-5700 |
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, 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, a 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 (check one):
| 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 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 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 JANUARY 12, 2023
1,333,333 Units With Each Unit Consisting
of:
One Share of Common Stock
One Warrant to Purchase
One Share of Common Stock
This is a firm commitment public offering of
1,333,333 units of securities (each, a “Unit”), with each Unit consisting of one share of common stock, $0.0001 par
value per share (“Common Stock”), and one warrant (“Warrant(s)”) to purchase one (1) share of Common Stock
of Curative Biotechnology, Inc., a Florida corporation, at a public offering price of $6.00 per Unit based on a reverse stock split
ratio of 1-for-400. On September 26, 2022, we filed an amendment to our amended and restated articles of incorporation with the
Secretary of State of the State of Florida (the “Secretary of State”) to effect a reverse stock split at a ratio of
1-for-400. While the amendment was approved by the Secretary of State, our Common Stock has not yet begun trading on a reverse stock
split basis. The reverse split will be effected following the effectiveness of the registration statement of which this prospectus
forms a part and prior to the completion of the offering contemplated by this prospectus. Each Warrant is
immediately exercisable for one (1) share of Common Stock at an exercise price of $9.00 per share (or 150% of the price of each Unit
sold in this offering, based on a public offering price of $6.00 per Unit, on a reverse stock split basis) and will expire five
(5) years from the date of issuance. The shares of Common Stock and Warrants are immediately separable and will be issued
separately. The Warrants will be issued in book-entry form pursuant to a warrant agency agreement between us and Issuer Direct
Corporation as warrant agent.
All references to share and per share amounts
in this Prospectus have been retroactively adjusted to reflect the 1-for-400 reverse stock split.
Our
Common Stock is presently traded on the OTC Pink Marketplace operated by OTC Markets Group Inc. (“OTC Pink”) under the symbol
“CUBT.” Our shares of Common Stock offered pursuant to this prospectus have been approved for listing on the NYSE American
under the symbol “CUBT”. We have applied to have our Warrants listed on the NYSE American under the symbol “CUBT WS”.
The listing of the Common Stock and the Warrants is a condition to this offering. No assurance can be given that our Warrant application
will be approved. On January 9, 2023, the last reported sales price for our Common Stock as quoted on the OTC Pink was $0.02 per
share or $8.00 on a post reverse split basis.
The Units will not be certificated. The Common
Stock and the Warrants included in the Units can only be purchased together in this offering, but the securities contained in the Units
are immediately separable and will be issued separately.
Management
and certain company insiders own an aggregate of 30,000,000 shares of our Series C Preferred Stock, which will automatically convert
into shares of Common Stock immediately prior to the closing of this offering. For a further description, please see the section of this
prospectus entitled “Description of Securities”, “Series C Preferred Stock.”
IN
REVIEWING THIS PROSPECTUS, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DESCRIBED IN THE SECTION TITLED “RISK FACTORS”
BEGINNING ON PAGE 7 OF THIS PROSPECTUS. INVESTORS SHOULD ONLY CONSIDER AN INVESTMENT IN THESE SECURITIES IF THEY CAN AFFORD THE LOSS
OF THEIR ENTIRE INVESTMENT.
We
are an “emerging growth company” under the federal securities laws and may elect to comply with certain reduced public company
reporting requirements for future filings.
We have determined that we are not a controlled
company within the meaning of the NYSE American rules, and we are not requesting any exemption related thereto.
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.
| | |
Per Unit | | |
Total | |
| Public offering price | |
$ | | | |
$ | | |
| Underwriting discounts (1) | |
$ | | | |
$ | | |
| Underwriter’s Warrants (2) | |
$ | | | |
$ | | |
| Proceeds to us before offering expenses (3) | |
$ | | | |
$ | | |
| (1) |
In
addition to the underwriting discounts and commissions, we have agreed to reimburse the underwriter for certain expenses, including
a non-accountable expense allowance equal to 1.0% of the gross proceeds we receive in this offering. See “Underwriting”
on page 74 of this prospectus for a description of these arrangements. |
| (2) |
The Underwriter’s Warrants will represent the
right to purchase 5.0% of the aggregate number of shares of common stock sold in this offering, excluding the overallotment option,
at an exercise price equal to 125% of the offering price per share |
| (3) |
We
estimate the total expenses of this offering will be approximately $960,000. Upon closing, we have also agreed to reimburse
$100,000 of the underwriter’s expenses relating to the offering, including for road show, diligence, and legal expenses. |
We have granted the underwriter a 45-day option
to purchase up to 199,999 additional Units at the initial public offering price less applicable underwriting discounts,
based on the reverse stock split ratio of 1-for-400. The amount
of offering proceeds to us presented in the table above does not give effect to any exercise of this over-allotment option (if any).
See “Underwriting” on page 74 of this prospectus for a description of these arrangements.
The
underwriter expects to deliver our shares and warrants to purchasers in this offering on or about
, 2023, subject to satisfaction of customary closing conditions.
Aegis
Capital Corp.
The
date of this prospectus is , 2023
TABLE
OF CONTENTS
You
should rely only on information contained in this prospectus. We have not, and the underwriter has not, authorized anyone to provide
you with additional information or information different from that contained in this prospectus. Neither the delivery of this prospectus
nor the sale of our securities means that the information contained in this prospectus is correct after the date of this prospectus.
This prospectus is not an offer to sell or the solicitation of an offer to buy our securities in any circumstances under which the offer
or solicitation is unlawful or in any state or other jurisdiction where the offer is not permitted.
The
information in this prospectus is accurate only as of the date on the front cover of this prospectus. Our business, financial condition,
results of operations and prospects may have changed since that date.
No
person is authorized in connection with this prospectus to give any information or to make any representations about us, the securities
offered hereby or any matter discussed in this prospectus, other than the information and representations contained in this prospectus.
If any other information or representation is given or made, such information or representation may not be relied upon as having been
authorized by us.
Neither
we nor the underwriter have done anything that would permit this offering or possession or distribution of this prospectus in
any jurisdiction where action for that purpose is required, other than the United States. You are required to inform yourself about,
and to observe any restrictions relating to, this offering and the distribution of this prospectus.
Until
, all dealers that effect transactions in these securities, whether or not participating in this offering,
may be required to deliver a prospectus. This is in addition to the dealer’s obligation to deliver a prospectus when acting
as underwriter and with respect to their unsold allotments or subscriptions.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some
of the statements in this prospectus contain “forward-looking statements.” Forward-looking statements are made based on our
management’s expectations and beliefs concerning future events impacting our company and are subject to uncertainties and factors
relating to our operations and economic environment, all of which are difficult to predict and many of which are beyond our control.
You can identify these statements from our use of the words “estimate,” “project,” “believe,” “intend,”
“anticipate,” “expect,” “target,” “plan,” “may” and similar expressions.
These forward-looking statements may include, among other things:
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statements
relating to projected growth and management’s long-term performance goals; |
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statements
relating to the anticipated effects on results of operations or our financial condition from expected developments or events; |
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statements
relating to our business and growth strategies; and |
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any
other statements which are not historical facts. |
Forward-looking
statements involve known and unknown risks, uncertainties and other important factors that could cause our actual results, performance
or achievements, or industry results, to differ materially from our expectations of future results, performance or achievements expressed
or implied by these forward-looking statements. These forward-looking statements may not be realized due to a variety of factors, including
without limitation:
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our
current and anticipated cash needs and our need for additional financing; |
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federal,
state and foreign regulatory requirements; |
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our
future ability to conduct clinical trials with respect to our products and services; |
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our
ability to develop and commercialize our products and services; |
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our
ability to enter into agreements to implement our business strategy; |
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the
acceptance of our products and services by patients and the medical community; |
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our
manufacturing capabilities to produce our products; |
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our
ability to maintain exclusive rights with respect to our licensed technology; |
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our
ability to protect our intellectual property; |
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our
ability to obtain and maintain an adequate level of insurance; |
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our
ability to obtain third party reimbursement for our products and services from private and governmental insurers; |
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the
effects of competition in our market areas; |
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our
reliance on certain key personnel; |
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further
sales or other dilution of our equity, which may adversely affect the market price of our Common Stock; and |
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other
factors and risks described under “Risk Factors” beginning on page 7 of this prospectus. |
You
should not place undue reliance on any forward-looking statement. We undertake no obligation to update any forward-looking statement
to reflect events or circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events.
PROSPECTUS
SUMMARY
This
summary is not complete and does not contain all of the information you should consider before investing in the securities offered by
this prospectus. Before making an investment decision, you should read the entire prospectus, and any prospectus supplement, carefully,
including the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” and our financial statements and the notes to the financial statements included elsewhere in this prospectus.
Prior
to purchasing our securities in this offering, we strongly urge each potential investor to obtain legal and tax advice as to the potential
tax and other effects to the investor as a result of purchasing such securities.
Unless
the context of this prospectus indicates otherwise, the terms “Curative Biotechnology,” “the Company,” “we,”
“us” or “our” refer to Curative Biotechnology, Inc. and the number of shares of Common Stock to be outstanding
after this offering excludes shares issuable upon any exercise of the Warrants offered by this prospectus.
What
We Do
We
are a life science company seeking to develop, in-license, sub-license or otherwise acquire early mid- or late-stage assets in the therapeutic
and medical device areas. We focus on development stage products that can be acquired at advantageous valuations and terms and assets
that we believe either already have, or possess the possibility for significant intellectual property. Additionally, we seek to acquire
assets that lend themselves to an accelerated clinical and/or regulatory development path. As of the date of this prospectus, we have
not submitted any INDs with the FDA for any of our product candidates.
We
have licensed four (4) pre-clinical assets and are initially focused on the following four (4) indications: (i) Rabies, (ii) Glioblastoma,
(iii) Age-Related Macular Degeneration, and (iv) COVID-19 vaccinations in patients with kidney failure.
Historically,
we have devoted our efforts and financial resources primarily to our general operations and the research and acquisition of our product
candidates.
Based
on our cash position, and assuming the receipt of approximately $6.8 million in net proceeds from this offering, we anticipate
utilizing the funds for the repayment of our outstanding secured convertible promissory note issued in March 2022, pre-clinical research,
including toxicology, pharmacokinetics, and safety studies in animals and manufacturing in anticipation for the regulatory submissions
of one or more investigational new drug application or IND with the United States Food and Drug Administration (FDA). If any of our proposed
INDs are approved, we will utilize the balance of the funds for manufacturing (for certain of our therapeutics as described herein),
to conduct our clinical trials (for certain of our therapeutics as described herein) and for general corporate working capital purposes.
It is still too early to determine if our product candidates will meet the requirements for IND approval.
Our development pipeline focuses on three (3) therapeutic areas: infectious
diseases, oncology, and degenerative eye disease. Under these therapeutic areas, we are focusing on four (4) programs: (i) Rabies, (ii)
COVID 19 Vaccines in Kidney Failure Patients, (iii) Glioblastoma, and (iv) Degenerative Eye Diseases Even if we are able to raise the
net proceeds described above, management has determined that it will still need to make a determination on what indications within those
four (4) programs to pursue as we will not have sufficient capital to pursue all of the below indications.
| (1) | Each
of these therapeutics have undergone certain toxicology and pharmacokinetics animal studies.
Please see further description in “Product Development” below for a further description
of the development of each indicated therapeutic. |
| (2) | Each
of these therapeutics have not undergone pre-clinical development. Please see further description
in “Product Development” below for a further description of the development of
each indicated therapeutic. |
Our
licensed assets target the following indications:
Infectious
Diseases
Rabies
— Rabies is a viral disease that causes inflammation of the brain in humans and other mammals. Early symptoms can include fever
and tingling at the site of exposure. These symptoms are followed by one or more of the following symptoms: nausea, vomiting, violent
movements, uncontrolled excitement, fear of water, an inability to move parts of the body, confusion, and loss of consciousness. Once
symptoms appear, the result is virtually always death. According
to the CDC, from 1960 to 2018, 127 human rabies cases were reported in the United States, with roughly a quarter resulting from dog bites
received during international travel. Of the infections acquired in the United States, 70% were attributed to bat exposures. We have
acquired an exclusive license to certain assets for the treatment of rabies. For a further description please see the sections of this
prospectus entitled “Our business – Product Development”, “Our Business – Licenses”, “Our
Business – Market” and “Risk Factors.”
COVID-19
in Patients with Kidney Failure — COVID-19 is a contagious disease caused by severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease has since spread worldwide, leading
to an ongoing pandemic.
Symptoms
of COVID-19 are variable, but often include fever, cough, headache, fatigue, breathing difficulties, and loss of smell and taste. At
least a third of people who are infected do not develop noticeable symptoms. Of those people who develop symptoms noticeable enough to
be classed as patients, most (81%) develop mild to moderate symptoms (up to mild pneumonia), while 14% develop severe symptoms (dyspnea,
hypoxia, or more than 50% lung involvement on imaging), and 5% suffer critical symptoms (respiratory failure, shock or multiorgan dysfunction).
Older people are at a higher risk of developing severe symptoms.
Patients
that received kidney transplants have impaired responses to mRNA COVID-19 vaccines – even after 4 vaccine shots. Additionally,
Kidney failure patients on dialysis do not initially respond as well to current vaccines and rapidly lose measurable antibodies when
compared to the general population.
We
have acquired an exclusive license to certain assets in order to develop and commercialize a COVID-19 vaccine. For a further description
please see the sections of this prospectus entitled “Our business – Product Development”, Our Business- Licenses”,
“Our Business – Market” and “Risk Factors.”
Oncology
Glioblastoma
— Glioblastoma is an aggressive type of cancer that begins within the brain. Initially, signs and symptoms of glioblastoma
are nonspecific. They may include headaches, personality changes, nausea, and symptoms similar to those of a stroke. Symptoms often worsen
rapidly and may progress to unconsciousness. Glioblastomas represent 15% of all brain tumors. The typical duration of survival following
diagnosis and treatment is 12–15 months, with fewer than 3–7% of people surviving longer than five years. About 3 in 100,000
people develop the disease per year. We have acquired an exclusive evaluation license (for evaluation purposes only) to certain assets
for the treatment of Glioblastoma. For a further description please see the sections of this prospectus entitled “Our business
– Product Development”, “Our Business – License”, “Our Business – Market”
and “Risk Factors.”
Retinal
Degenerative Disease
There
are numerous degenerative eye diseases that cause blindness or low vision. The Center for Disease Control or CDC states that more than
4.2 million Americans aged 40 or older are either legally blind or have low vision. The leading cause of blindness and low vision in
the United States are primarily age-related eye diseases such as age-related macular degeneration or diabetic retinopathy, among others.
We
have entered into an exclusive license agreement to develop and commercialize therapeutics for retinal degenerative diseases with certain
licensed assets. Additionally, on March 15, 2022, we entered into a cooperative research and development agreement (“CRADA”)
with the National Eye Institute. For a further description please see the sections of this prospectus entitled “Our Business
– Product Development”, “Our Business – Licenses”, “Our Business – Market”
and “Risk Factors.” While our current focus is on Intermediate Dry Macular Degeneration and Geographic Atrophy,
the Company does have the right under the license to pursue other indications with Metformin but has no plans to undertake any development
related to such indications at this time.
Age-Related
Macular Degeneration — Age-Related Macular Degeneration is a visually threatening condition, most often found in patients over
age 60. Early and Intermediate AMD are characterized by enlarged drusen behind the eye’s retina. Currently there are no approved
drug treatments for Dry AMD or Geographic Atrophy (late-stage dry AMD).
Impact
of COVID-19 on our Company
Based
upon our early stage of development we have not been materially impacted by COVID-19. However, in general, the biotech and pharmaceutical
industries have been negatively impacted by the COVID-19 pandemic. From recruitment of patients and the conduct of clinical trials to
manufacturing, CRO functions and patient travel, virtually every part of the drug development system has been negatively impacted. In
the event we receive approval for one of our anticipated INDs, the manufacturing and testing of our drug candidates will undoubtedly
be more challenging than it would have been had there been no pandemic.
Additionally,
our ability to carry out any of the programs and indications described above will be contingent on our being able to raise capital
as described in the Section of this prospectus entitled “Use of Proceeds”; without which some or all of the
programs and indications will not be able to move forward. Please additionally see the sections of this prospectus entitled
“Risk Factors” and “Our Business” for a further description.
Orphan
Designation
An
Orphan drug is defined as one “intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one
that affects less than 200,000 persons in the US” (which equates to approximately 6 cases per 10,000 population) “or meets
cost recovery provisions of the act.” In the European Union (EU), the European Medicines Agency (EMA) defines a drug as “orphan”
if it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically and seriously debilitating condition
affecting not more than 5 in 10,000 EU people. EMA also qualifies a drug as orphan if – without incentives – it would be
unlikely that the drug in the EU would generate sufficient benefit for the affected people and for the drug manufacturer to justify
the investment.
We
have received Orphan drug designation with respect to our proposed Rabies therapeutic from the U.S. FDA on November 24, 2014. We have
not received Orphan drug designation from the European Medicines Agency or EMA.
Going
Concern
Our
auditors’ report on our December 31, 2021 audited financial statements expressed an opinion that our capital
resources as of the date of their audit report were not sufficient to sustain operations or complete our planned activities for the upcoming
year unless we raised additional funds. Additionally, we have had a history of net losses and our current cash level raises substantial
doubt about our ability to continue as a going concern. If we do not obtain additional funds, we may no longer be able to continue as
a going concern and will cease operation which means that our shareholders will lose their entire investment.
Listing
on the NYSE American Market
Our
shares of Common Stock offered pursuant to this prospectus have been approved for listing on the NYSE American under the symbol “CUBT”.
We have applied to have our Warrants listed on the NYSE American under the symbol “CUBT WS”. The listing of the Common Stock
and the Warrants is a condition to this offering. Upon consummation of this offering, we expect to list our Common Stock and Warrants
on the NYSE American, at which point our Common Stock will cease to be traded on the OTC Pink. No assurance can be given that our Warrant
application will be approved. NYSE American listing requirements include, among other things, a stock price threshold. As a result, prior
to effectiveness, we will need to take the necessary steps to meet the NYSE American listing requirements, including but not limited
to a reverse split of our Common Stock. If NYSE American does not approve the listing of our Warrants, we will not proceed with this
offering.
Reverse
Stock Split
On
October 8, 2021, our stockholders approved a reverse stock split within the range of 1-for-2 to 1-for-10,000 of our issued and
outstanding shares of Common Stock and authorized the board of directors (the “Board”), in its discretion, to determine
the final ratio, effective date, and date of filing of the certificate of amendment to our articles of incorporation in connection
with the reverse stock split. On September 26, 2022, we filed an amendment to our amended and restated articles of
incorporation with the Secretary of State to effect a reverse stock split at a ratio of 1-for-400. While the amendment was
approved by the Secretary of State, our Common Stock has not yet begun trading on a reverse stock split basis. The reverse split
will be effected following the effectiveness of the registration statement of which this prospectus forms a part and prior to the completion of the offering contemplated by this prospectus. The purpose of the reverse stock split is to meet the NYSE American minimum stock price requirement for
listing our Common Stock, which is a condition to the completion of this Offering. The reverse stock split will not change the
number of authorized shares of Common Stock which will remain at 1,100,000,000 shares.
Corporate
History
We
were incorporated in 1995 in the State of Nevada, under the name Frozen Assets, Inc. Since we incorporated, we have changed our name
a number of times: (i) in March 1998 to Growth Industries, Inc., (ii) in July 1998 to Fragrance Express, Inc., (ii) in October 1998 to
National Boston Medical Inc., and (iii) in May 2004, to Storage Innovation Technologies, Inc. In October of 2007 we reincorporated in
the State of Florida under the name Connectyx Technologies Holdings Group Inc. In February of 2020 the Company changed the composition
of its Board of Directors and the current management as majority shareholders acquired voting control of the Company. In November of
2020 we changed our name to Curative Biotechnology, Inc. and adopted our current business plan.
Implications
of Being an Emerging Growth Company
As
an emerging growth company, we intend to take advantage of an extended transition period for complying with new or revised accounting
standards as permitted by The JOBS Act.
To
the extent that we continue to qualify as a “smaller reporting company,” as such term is defined in Rule 12b-2 under the
Securities Exchange Act of 1934, as amended (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: (i) not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes Oxley Act; (ii)
scaled executive compensation disclosures; and (iii) the requirement to provide only two years of audited financial statements, instead
of three years.
Corporate
Information
Our
headquarters are located at 1825 NW Corporate Blvd, Suite 110, Boca Raton, FL 33431. Our telephone number is (561) 907-8990. We maintain
certain information on our website at www.curativebiotech.com. The information on our website is not (and should not be considered) part
of this prospectus and is not incorporated into this prospectus by reference.
Summary
of Risk Factors
Our
business is subject to a number of risks and uncertainties, including those highlighted in the section titled “Risk Factors”
immediately following this prospectus summary. Some of these risks are:
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We
have a limited operating history and may be unable to predict future operations; |
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Our
independent auditor’s report for the years ended December 31, 2021, and 2020, contains a qualification as to our ability to
continue as a going concern, and management, in consultation with our independent auditor has also determined there is a going concern
as of September 30, 2022; |
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We
are an early-stage company, have no product revenues, are not profitable and may never be profitable; |
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We
will need to obtain a significant amount of financing to initiate and complete our clinical trials and implement our business plan;
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We
have incurred significant losses in prior periods, and losses in the future could have a material adverse effect on our financial
condition, our ability to pay our debts as they become due, and on our cash flows; |
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We
expect to rely on third parties to conduct our clinical trials and all or most aspects of our research and preclinical testing, and
those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research,
or testing; |
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We
may rely entirely on third parties for the manufacturing of our product candidates or other product candidates that we may develop
for preclinical studies and clinical trials and expect to continue to do so for commercialization. Our business could be harmed if
those third parties fail to provide us with sufficient quantities of drug product, or fail to do so at acceptable quality levels
or prices; |
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If
we fail to comply with the obligations of our licensing agreements or these agreements are terminated or we otherwise experience
disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our
business; |
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If
we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected
and our business would be harmed. |
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The
insurance coverage and reimbursement status of newly-approved products is uncertain. Our product candidates may become subject to
unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would
harm our business. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our
ability to market those products and decrease our ability to generate revenue. |
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We
have paid no dividends and we do not anticipate paying any cash dividends in the foreseeable future. |
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Investors
in this offering will experience immediate and substantial dilution in net tangible book value. |
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If,
following this offering, our Common Stock becomes classified again as a “penny stock,” the restrictions of the penny
stock regulations of the Securities and Exchange Commission, or SEC, may result in less liquidity for our Common Stock. |
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A
reverse stock split could cause our stock price to decline relative to its value before the split. |
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Even
if the reverse stock split achieves the requisite increase in the market price of our Common Stock, we cannot assure you that we
will be able to continue to comply with the minimum trading price requirement of NYSE American. |
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Following
the reverse stock split, the resulting market price of our Common Stock may not attract new investors, including institutional investors,
and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our Common Stock may not
improve. |
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Assuming
the conversion of our Series C Preferred Stock, the holders of our Series B Preferred Stock will still have certain rights, preferences,
and privileges over our shares of Common Stock, including the right to approve certain transactions. |
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In
order to have our securities continue to be listed on the NYSE American, among other requirements, we will need to add independent
qualified persons to our Board. |
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In
connection with the reverse stock split, we will have additional authorized shares of Common Stock available for issuance; the issuance
of such additional shares would dilute the percentage ownership of existing stockholders. |
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The Common Stock purchase warrant
issued in our March 2022 secured note offering may be adjusted in the number of shares underlying the warrant upon completion of
this offering, which would result in further dilution to our shareholders. |
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As
of January 9, 2023, our management team and Board of Directors have unilateral control over key decision making as a result
of their control of a majority of our voting stock. |
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Our
amended and restated Bylaws provide that the state of Florida is the sole and exclusive forum for substantially all disputes between
us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with
us or our directors, officers, or employees. |
If
we are unable to adequately address these and other risks we face, our business, financial condition, operating results and prospects
may be adversely affected.
Summary
of the Offering
| Securities Offered: |
|
1,333,333 Units, each consisting of one share of Common Stock and one Warrant to purchase one share of Common Stock.
The Units will not be certificated or issued in stand-alone form. The shares of our Common Stock and the Warrants comprising the Units
are immediately separable upon issuance and will be issued separately; but will be purchased together in this offering. |
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Description of Warrants included in Units: |
|
The exercise price of the Warrants is $9.00 per share (150% of
the public offering price per Unit). Each Warrant is exercisable for one share of Common
Stock. Each Warrant will be exercisable immediately upon issuance and will expire five years
after the initial issuance date. The terms of the Warrants will be governed by a warrant
agency agreement, dated as of the effective date of this offering, between us and Issuer
Direct Corporation as the warrant agent (the “Warrant Agent”). The Warrants will
be subject to redemption at a redemption price of $0.01 per Warrant commencing six months from issuance subject to the condition
that the volume weighted average price of the Company’s common stock exceeds 200% of
the initial exercise price for twenty (20) consecutive trading days and subject to certain other
conditions set forth in the Warrants. This
prospectus also relates to the offering of the shares of Common Stock issuable upon exercise
of the Warrants. For more information regarding the warrants, you should carefully read the
section titled “Description of Our Securities—Warrants” in this prospectus. |
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| Common Stock Outstanding prior to the Offering: |
|
1,448,177 shares based
on the reverse stock split ratio of 1-for-400 (which amount does not include the conversion of Series C Preferred Stock). |
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| Common Stock Outstanding Immediately after the Offering: |
|
3,402,157 shares, including
the conversion of Series C Preferred Stock into 620,647 shares of Common Stock (or 3,602,156 shares, if the underwriter
exercises its over-allotment option in full), based on a public offering price of $6.00 per share. |
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| Underwriter’s Over-Allotment Option: |
|
The underwriting agreement provides that we will grant to the underwriter,
an option, exercisable within 45 days after the date of this prospectus, to acquire up to an additional 15% of the total number of
shares of Common Stock and Warrants sold by us pursuant to this offering, solely for the purpose of covering over-allotments,
if any. |
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| Use of Proceeds: |
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We estimate that we will receive net proceeds of approximately $6.8
million from our sale of Units in this offering assuming the sale of all Units at $6.00 per share (based on the reverse split
ratio as described on the cover page of this prospectus), after deducting underwriting discounts and estimated offering expenses
payable by us. We intend to use the net proceeds of this offering, including any over-allotment amount, as follows: (i) for the repayment
of amounts due under our March 2022 secured convertible promissory note and May 2022 unsecured promissory note, and (ii) for our
programs, we will complete necessary preclinical trials, IND-enabling studies, manufacturing, and other necessary costs related to
submitting IND applications for our product candidates. In the event we receive approval of one or more of our proposed INDs, we
intend to proceed with up to two (2) clinical trials (Rabies and Dry-Age Macular Degeneration). The remainder of funds will be used
for general corporate and business purposes; however, the use of the net proceeds is subject to change at the complete and absolute
discretion of our management. For a more complete description of our anticipated use of proceeds from this offering, see “Use
of Proceeds.” |
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| Proposed Trading Symbol: |
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Our shares of Common Stock offered
pursuant to this prospectus have been approved for listing on the NYSE American under the symbol
“CUBT”. We have applied to have our Warrants listed on the NYSE American under the symbol
“CUBT WS”. The listing of the Common Stock and the Warrants is a condition to this offering.
If our Warrant listing application is not approved, we will not complete this offering. |
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| Series C Preferred Stock Conversion and anti-dilution rights: |
|
Immediately prior to the closing of the offering, the holders of the
issued and outstanding shares of Series C Preferred Stock have agreed to convert their shares of Series C Preferred Stock into shares
of Common Stock. The Series C Preferred Stock will collectively convert into thirty percent (30%) of the total issued and outstanding
shares of Common Stock on a post conversion basis immediately prior to the closing of the offering, or approximately 620,647
shares of Common Stock, without the payment of any additional consideration by the holders, based on the reverse stock split ratio
as described on the cover page of this prospectus. |
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| Risk Factors: |
|
Investing in our securities involves substantial risks. You should carefully review and consider the “Risk Factors” section of this prospectus beginning on page 7 and the other information in this prospectus for a discussion of the factors you should consider before you decide to invest in this offering. |
The number of shares of Common
Stock that will be outstanding after this offering set forth above (3,402,157 shares) is based upon 1,448,177 shares of Common Stock
outstanding as of January 9, 2023, and gives effect to the reverse stock split at a ratio of 1-for-400, the issuance of 620,647
shares of Common Stock upon conversion of the Series C Preferred Stock, as well as the sale of 1,333,333 shares of Common Stock underlying
the Units in the offering but does not include, as of that date:
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176,246
shares of Common Stock issuable upon the exercise of outstanding warrants having an average weighted exercise price of $31.86. Notwithstanding,
such amount of warrants will increase by 262,432 shares of Common Stock (assuming the $6.00 offering price and utilizing the
1-for-400 reverse stock split as set forth on the cover page of this Prospectus) underlying the warrant issued to the lender in our
March 2022 convertible note offering pursuant to an adjustment feature in the number of shares underlying the warrant upon the consummation
of an offering at least $7.2 million at a price per share in such offering that if multiplied by 75%, would be less than $20.00; |
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18,641
shares of Common Stock issuable upon the exercise of outstanding equity awards pursuant to our 2021 Equity Incentive Plan; and |
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the exercise of the Warrants contained in the Units; and |
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the
exercise by the underwriter of its option to purchase additional Units. |
RISK
FACTORS
In
addition to the other information included in this prospectus, the following factors should be carefully considered before making a decision
to invest in our securities. Any of the following risks, either alone or taken together, could materially and adversely affect our business,
financial condition, liquidity, results of operations and prospects. If one or more of these or other risks or uncertainties materialize,
or if our underlying assumptions prove to be incorrect, we could be materially and adversely affected. There may be additional risks
that we do not presently know or that we currently believe are immaterial that could also materially and adversely affect our business,
financial condition, liquidity, results of operations and prospects. In any such case, the market price of our Common Stock could decline
substantially and you could lose all or a part of your investment.
Risks
Related to Our Company and Stage of Development
We
may not be able to continue as a going concern if we do not obtain additional financing.
We have incurred losses
since our inception and have not demonstrated an ability to generate revenues from the development and sales of our proposed therapeutic
products. Our ability to continue as a going concern is dependent on raising capital from the sale of our Common Stock and/or obtaining
debt financing. Our cash balance at September 30, 2022 was $636. Based on our current expected level of operating expenditures, we expect
to be able to fund our operations until February of 2023. Our ability to remain a going concern past such time is wholly
dependent upon our ability to continue to obtain sufficient capital to fund our operations. Despite our ability to secure capital in
the past, there can be no assurance that additional equity or debt financing will be available to us when needed or that we may be able
to secure funding from any other sources. In the event that we are not able to secure funding, we may be forced to curtail operations,
delay or stop ongoing clinical trials, cease operations altogether or file for bankruptcy.
Our
independent auditor’s report for the years ended December 31, 2021, and 2020, contains a qualification as to our ability to continue
as a going concern, and management, in consultation with our independent auditor has also determined there is a going concern as of September
30, 2022.
Due
to the uncertainty of our ability to meet our current operating and capital expenses, in our audited annual consolidated financial statements
for the years ended December 31, 2021, and 2020, our independent auditor’s report included a paragraph in their opinion to our
financial statements regarding concerns about our ability to continue as a going concern. Recurring losses from operations raise substantial
doubt about our ability to continue as a going concern. The presence of the going concern paragraph and footnote to our financial statements
may have an adverse impact on the relationships we are developing and plan to develop with third parties as we continue the development
of our products and could make it challenging and difficult for us to raise additional financing, all of which could have a material
adverse impact on our business and prospects and result in a significant or complete loss of your investment.
Management,
in consultation with our independent auditor has determined that there is a going concern as of September 30, 2022. Assuming the
receipt of net proceeds of $6.8 million in the offering described in this Prospectus, the going concern may be mitigated in the
short term. Notwithstanding, given that the Company does not anticipate generating significant revenues in the short term, the Company
may be subject to a future going concern in the event that the Company is unable to raise additional capital or otherwise sufficiently
fund its operations.
We
have a limited operating history, which may make it difficult for investors to predict future performance based on current operations.
We have a limited operating history upon which investors
may base an evaluation of our potential future performance. In particular, our limited staff and operating history means that
there is a high degree of uncertainty regarding our ability to (i) develop and commercialize our technologies
and proposed products (ii) obtain regulatory approval to commence the marketing of our products, (iii) manage growth,
(iv) achieve market acceptance or insurance reimbursement for any of our proposed products, if successfully developed, or (v)
respond to competition. As a result, there can be no assurance that we will be able to develop or maintain consistent revenue
sources, or that our operations will be profitable and/or generate positive cash flows.
Any
forecasts we make about our operations may prove to be inaccurate. We must, among other things, determine appropriate risks, rewards,
and level of investment in our product lines, respond to economic and market variables outside of our control, respond to competitive
developments and continue to attract, retain, and motivate qualified employees. There can be no assurance that we will be successful
in meeting these challenges and addressing such risks and the failure to do so could have a materially adverse effect on our business,
results of operations, and financial condition. Our prospects must be considered in light of the risks, expenses, and difficulties frequently
encountered by companies in the early stage of development. As a result of these risks, challenges, and uncertainties, the value of your
investment could be significantly reduced or completely lost.
We
are an early-stage company, have no product revenues, are not profitable and may never be profitable.
Since the implementation
of the Curative Biotechnology business plan in January 2020 through September 30, 2022, we have raised approximately $3.9 million
through the sale of our securities. During this same period, we have recorded an accumulated deficit of approximately $27.6 million.
Our net loss for the two most recent fiscal years ended December 31, 2021 and 2020 were $5,340,354 and $4,670,255, respectively. None
of our products in development have received approval from the FDA, or other regulatory authorities; we have no sales and have never
generated revenues, nor do we expect to generate revenues for the foreseeable future from the sales of our therapeutic products. We are
currently focusing our efforts on the development of our product candidates. We expect to incur significant operating losses for the
foreseeable future as we continue the research, pre-clinical and clinical development of our product candidates as well as the possible
in-licensing of additional clinical and pre-clinical assets. Accordingly, we will need additional capital to fund our continuing operations
and any expansion plans. Since we do not generate any revenue, the most likely sources of such additional capital include the sale of
our securities, a strategic licensing collaboration transaction or joint venture involving the rights to one or more of our product candidates,
or from grants. To the extent that we raise additional capital by issuing equity securities, our stockholders are likely to experience
dilution with regard to their percentage ownership of the company, which may be significant. If we raise additional funds through collaborations
or licensing arrangements, we may be required to relinquish some or all the rights to our technologies, product candidates, or grant
licenses on terms that are not favorable to us. If we raise additional capital by incurring debt, we could incur significant interest
expense and become subject to covenants that could affect the manner in which we conduct our business, including securing such debt obligations
with our assets.
Our
product candidates are at various stages of early development and significant financial resources are required to develop commercially
viable products and obtain regulatory approval to market and sell such products. We will need to devote significantly more research and
development efforts, financial resources and personnel to develop commercially viable products and obtain regulatory approvals. We may
encounter hurdles and unexpected issues as we proceed in the development of our other product candidates.
We
will need to obtain a significant amount of financing to initiate and complete our clinical trials and implement our business plan.
Since
the implementation of the Curative Biotechnology business plan in January 2020, we have not generated revenues from our operations and
have funded our operations through the sale of our equity securities and debt securities. The implementation of our business plan, as
discussed in this prospectus under the caption “Business,” will require the receipt of sufficient equity and/or debt financing
to fund our clinical trials and other research and development efforts and provide for general working capital to otherwise fund our
operations. We anticipate that we will need approximately $38 million and a period of two (2) years to reach inflection points in all
current indications underlying programs that we are actively pursuing. An inflection point, as used herein, is a point in product development
where we believe we have enough significant value to reasonably expect to be able to partner out, license, and/or sell the program to
an entity with the appetite and resources to take it to launch and commercialization. We will also require a substantial amount of additional
funding to implement our other indications described in this prospectus under the caption “Business,” including our in-licensing
strategy if such other programs are acquired. Although we believe the net proceeds from this offering will be sufficient to reach certain
inflection points related to our current development plans, as applicable to the specific programs and indications, we do not believe
it will be sufficient to receive FDA approval to market such products. Accordingly, we will need additional capital in the future. No
assurance can be given that the anticipated amounts of required funding are correct or that we will be able to accomplish our goals within
the timeframes projected. In addition, no assurance can be given that we will be able to obtain any required financing on commercially
reasonable terms or otherwise. In the event we do not obtain the financing required for the above purposes, we may have to curtail our development, marketing and promotional activities, which would have a material adverse effect on our business, financial
condition and results of operations, and ultimately, we could be forced to discontinue our operations and liquidate.
We
have incurred significant losses in prior periods, and losses in the future could have a material adverse effect on our financial condition,
our ability to pay our debts as they become due, and on our cash flows.
We have incurred significant losses in prior
periods. For the nine months ended September 30, 2022 and 2021, we incurred net losses of $4,102,134 and $4,404,418,
respectively, and as of September 30, 2022 had an accumulated deficit of $31.0 million. For the years ended December
31, 2021 and 2020, we incurred net losses of $5,340,354 and, $4,670,255, respectively. Any losses in the future could have a material
adverse effect on our financial condition, our ability to pay our debts as they become due, and on our cash flows.
We
require additional financing to sustain our operations and execute our business plan. If we fail to secure the required additional financing
on acceptable terms and in a timely manner, our ability to implement our business plan will be compromised and we may be unable to sustain
our operations.
We
have limited capital resources and operations. To date, our operations have been funded entirely from the proceeds of debt and equity
financings. We will require substantial additional capital in the near future to acquire or in-license assets, develop our intellectual
property base, and complete our pre-clinical and clinical stage studies. We may be unable to obtain additional financing on terms acceptable
to us, or at all. Even if we obtain financing for our near-term operations, we expect that we will require additional capital thereafter.
Our capital needs will depend on numerous factors including: (a) the level of our investment in research and development; (b) clinical
trials and (c) the amount of our capital expenditures, including acquisitions. We cannot assure you that we will be able to obtain capital
in the future to meet our needs. If we raise additional funds through the issuance of equity or convertible debt securities, the percentage
ownership held by our existing shareholders will be reduced and our shareholders may experience significant dilution. In addition, new
securities may contain rights, preferences, or privileges that are senior to those of our Common Stock. If we raise additional capital
by incurring debt, this will result in increased interest expense. If we raise additional funds through the issuance of securities, market
fluctuations in the price of our shares of Common Stock could limit our ability to obtain equity financing. We cannot give any assurance
that any additional financing will be available to us, or if available, will be on terms favorable to us. If we are unable to raise capital
when needed, our business, financial condition, and results of operations would be materially adversely affected, and we could be forced
to reduce or discontinue our operations.
Our
company relies heavily upon a limited number of key employees.
We
have been, and continue to be, heavily dependent upon the expertise and management of I Richard Garr, Paul Michaels and Barry Ginsberg,
and our future performance will depend upon their continued services. The loss of any of these individuals could seriously interrupt
our business operations and could have a very negative impact on our ability to fulfill our business plan and to carry out our existing
development stage operations. We currently do not maintain key man life insurance. There can be no assurance that suitable replacements
could be found for any of these individuals upon retirement, resignation, or upon death or disability.
The
limited public company experience of our management could adversely impact our ability to comply with the reporting requirements of U.S.
securities laws.
Our
management has limited public company experience, which could impair our ability to comply with legal and regulatory requirements such
as those imposed by Sarbanes-Oxley Act of 2002. A majority of our senior management has never had sole responsibility for managing a
publicly traded company. Such responsibilities include complying with federal securities laws and making required disclosures on a timely
basis. Our management may not be able to implement programs and policies in an effective and timely manner that adequately respond to
such increased legal, regulatory compliance and reporting requirements, including the establishing and maintaining internal controls
over financial reporting. Any such deficiencies, weaknesses or lack of compliance could have a materially adverse effect on our ability
to comply with the reporting requirements of the Exchange Act, which is necessary to maintain our public company status. If we were to
fail to fulfill those obligations, our ability to continue as a U.S. public company would be in jeopardy in which event you could lose
your entire investment in our company.
The
impact of COVID-19 and related risks could materially affect our results of operations and prospects.
Beginning
in March 2020, the global pandemic related to the novel coronavirus COVID-19 began to impact the global economy. Because of the size
and breadth of this pandemic, all of the direct and indirect consequences of COVID-19 are not yet known and may not emerge for some time.
Risks presented by the ongoing effects of COVID-19 include, among others, the following:
Pre-Clinical
and Clinical Studies. We anticipate that the COVID-19 pandemic may negatively impact our contemplated pre-clinical and clinical trials.
Due to the worldwide efforts being taken to combat COVID-19 and the increased pre-clinical and clinical work being done in this respect,
we believe that it may be difficult for certain needed laboratory supplies, equipment and other materials to be obtained in order to
conduct our pre-clinical and clinical studies. We also anticipate that, due to a fear of COVID-19 transmission, there may be a hesitancy
on the part of certain individuals to become clinical trial participants. We hope that these possible negative effects will lessen as
more of the population becomes vaccinated; however, the impact that the vaccinations will have is uncertain at this time.
Adverse
Legislative and/or Regulatory Action. Federal, state and local government actions to address and contain the impact of COVID-19 may
adversely affect us. For example, we may be subject to legislative and/or regulatory action that negatively impacts the manner in which
the clinical trials may be conducted.
Operational
Disruptions and Heightened Cybersecurity Risks. Our operations could be disrupted if key members of our senior management or a significant
percentage of our workforce are unable to continue to work because of illness, government directives or otherwise. In addition, in connection
with increased remote working arrangements, we face a heightened risk of cybersecurity attacks or data security incidents and are more
dependent on internet and telecommunications access and capabilities.
Risks
Related to Our Business
Drug
development is a highly uncertain undertaking and involves a substantial degree of risk.
Pharmaceutical
and biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. To date, we
have focused principally on identifying, acquiring or in-licensing and developing our product candidates. Our product candidates are
at the discovery, lead optimization and preclinical stage or in preparation to begin early-stage clinical trials.
Our
product candidates will require substantial additional development time, including extensive clinical research, and resources before
we would be able to apply for or receive regulatory approvals and begin generating revenue from product sales. Because of the numerous
risks and uncertainties associated with drug development, we are unable to predict the timing or amount of our expenses, or when we will
be able to generate revenue. In addition, our expenses could increase beyond our current expectations if we are required by the FDA,
or comparable foreign regulatory authorities, to perform nonclinical or preclinical studies or clinical trials in addition to those that
we currently anticipate, or if there are any delays in any of our or our future collaborators’ clinical trials or the development
of our product candidates that we may identify. Even if our future product candidates that we may identify are approved for commercial
sale, we may incur significant costs associated with commercializing any approved product candidate and ongoing compliance efforts.
We
may never be able to develop or commercialize some of our drugs or obtain marketing authority. Revenue from the sale of any product candidate
for which regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories for which we gain
regulatory approval, the accepted price for the product, the ability to obtain reimbursement at any price and whether we own the commercial
rights for that territory. Our growth strategy depends, in part, on our ability to generate revenue. In addition, if the number of addressable
patients is not as anticipated, the indication approved by regulatory authorities is narrower than expected, or the reasonably accepted
population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue
from sales of such products, even if approved.
Our
product candidates are in varying stages of development, all of which may require a lengthy and expensive development process with uncertain
outcomes and the potential for substantial delays. We cannot give any assurance that any of our product candidates will receive regulatory
approval, which is necessary before they can be commercialized.
Before
obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials
to demonstrate the safety and efficacy of the product candidates in humans. To date, we have focused substantially all of our efforts
and financial resources on identifying, acquiring, and developing our product candidates, and providing general and administrative support
for these operations. We cannot be certain that any clinical trials will be conducted as planned or completed on schedule, if at all.
Our inability to successfully complete preclinical and clinical development could result in additional costs to us and negatively impact
our ability to generate revenue. Our future success is dependent on our ability to successfully develop, obtain regulatory approval for,
and then successfully commercialize product candidates. We currently have no products approved for sale and have not generated any revenue
from sales of drugs, and we may never be able to develop or successfully commercialize a marketable drug.
All
of our product candidates require additional development; management of preclinical, clinical, and manufacturing activities; and regulatory
approval. In addition, we will need to obtain adequate manufacturing supply; build a commercial organization; commence marketing efforts;
and obtain reimbursement before we generate any significant revenue from commercial product sales, if ever, for any products we commercialize
ourselves. Many of our product candidates are in early-stage research or translational phases of development, and the risk of failure
for these programs could be high. We cannot be certain that any of our product candidates will be successful in clinical trials or receive
regulatory approval. Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials.
If we do not receive regulatory approvals for our product candidates, we may not be able to continue operations, which may result in
us dissolving the Company, out-licensing the technology or pursuing an alternative strategy.
If
we are unable to obtain regulatory approval in one or more jurisdictions for any product candidates that we may identify and develop,
our business will be substantially harmed.
We
cannot commercialize a product until the appropriate regulatory authorities have reviewed and approved the product candidate. Approval
by the FDA and comparable foreign regulatory authorities is lengthy and unpredictable, and depends upon numerous factors, including substantial
discretion of the regulatory authorities. Approval policies, regulations, or the type and amount of nonclinical or clinical data necessary
to gain approval may change during the course of a product candidate’s development and may vary among jurisdictions, which may
cause delays in the approval or the decision not to approve an application. We have not obtained regulatory approval for any product
candidates, and it is possible that our current product candidates and any other product candidates which we may seek to develop in the
future will not ever obtain regulatory approval. We cannot be certain that any of our product candidates will receive regulatory approval
or be successfully commercialized even if we receive regulatory approval.
Obtaining
marketing approval is an extensive, lengthy, expensive and inherently uncertain process, and regulatory authorities may delay, limit
or deny approval of our product candidates for many reasons, including but not limited to:
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the
inability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that the applicable product
candidate is safe and effective as a treatment for our targeted indications; |
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the
FDA or comparable foreign regulatory authorities may disagree with the design, endpoints or implementation of our clinical trials; |
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the
population studied in the clinical program may not be sufficiently broad or representative to assure safety or efficacy in the full
population for which we seek approval; |
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the
FDA or comparable foreign regulatory authorities may require additional preclinical studies or clinical trials beyond those that
we currently anticipate; |
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the
FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical
trials; |
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the
data collected from clinical trials of product candidates that we may identify and pursue may not be sufficient to support the submission
of an NDA or BLA, or other submission for regulatory approval in the United States or elsewhere; |
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we
may be unable to demonstrate to the FDA or comparable foreign regulatory authorities that a product candidate’s risk-benefit
ratio for its proposed indication is acceptable; |
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the
FDA or comparable foreign regulatory authorities may identify deficiencies in the manufacturing processes, test procedures and specifications,
or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and |
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the
approval policies or regulations of the FDA or comparable foreign regulatory authorities may change in a manner that renders the
clinical trial design or data insufficient for approval. |
The
lengthy approval process, as well as the unpredictability of the results of clinical trials and evolving regulatory requirements, may
result in our failure to obtain regulatory approval to market product candidates that we may pursue in the United States or elsewhere,
which would significantly harm our business, prospects, financial condition and results of operations.
We
may encounter substantial delays in pre-clinical studies and clinical trials or may not be able to conduct or complete clinical trials
on the expected timelines, if at all.
Pre-clinical
studies and clinical testing is expensive, time consuming, and subject to uncertainty. We cannot guarantee that any of our planned studies
or clinical trials will be conducted as planned or completed on schedule, if at all. Moreover, even if these studies and/or trials are
initiated or conducted on a timely basis, issues may arise that could result in the suspension or termination of such studies or trials.
A failure can occur at any stage of testing, and our ongoing and future clinical trials may not be successful. Failure to successfully
complete any pre-clinical studies or clinical trials could have a material adverse effect on our company, business and prospects.
Our
clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of product candidates that we may identify
and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory approval and commercialization.
Before
obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex
and expensive nonclinical studies, preclinical studies and clinical trials that the applicable product candidate is both safe and effective
for use in each target indication, and in the case of our product candidates regulated as biological products, that the product candidate
is safe, pure, and potent for use in its targeted indication. Each product candidate must demonstrate an adequate risk versus benefit
profile in its intended patient population and for its intended use.
Clinical
testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during
the clinical development process. Most product candidates that begin clinical trials are never approved by regulatory authorities for
commercialization. We have limited experience in designing clinical trials and may be unable to design and execute a clinical trial to
support marketing approval.
Use
of our product candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay
or halt their clinical development, prevent their regulatory approval, cause us to suspend or discontinue clinical trials, abandon a
product candidate, limit their commercial potential, if approved, or result in other significant negative consequences that could severely
harm our business, prospects, operating results and financial condition.
As
is the case with pharmaceuticals generally, it is likely that there may be side effects and adverse effects associated with our product
candidates’ use. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or
unexpected characteristics. Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt,
delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or
comparable foreign regulatory authorities. The drug-related side effects could affect patient recruitment or the ability of enrolled
patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial
condition and prospects significantly.
Even
if we obtain FDA approval for product candidates that we may identify and pursue in the United States, we may never obtain approval to
commercialize any product candidates outside of the United States, which would limit our ability to realize their full market potential.
In
order to market any products outside of the United States, we must establish and comply with numerous and varying regulatory requirements
of other countries regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities
in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country.
Approval processes vary among countries and can involve additional product testing and validation and additional or different administrative
review periods from those in the United States, including additional preclinical studies or clinical trials, as clinical trials conducted
in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States,
a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price
that we intend to charge for our products is also subject to approval.
Seeking
foreign regulatory approval could result in difficulties and costs and require additional nonclinical studies or clinical trials which
could be costly and time-consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction
of our product candidates in those countries. The foreign regulatory approval process may include all of the risks associated with obtaining
FDA approval. We do not have any product candidates approved for sale in any jurisdiction, including international markets, and we do
not have experience in obtaining regulatory approval in international markets. If we fail to comply with regulatory requirements in international
markets or to obtain and maintain required approvals, or if regulatory approval in international markets is delayed, our target market
will be reduced and our ability to realize the full market potential of our products will be harmed.
Even
though we may apply for orphan drug designation for our product candidates, we may not be able to obtain orphan drug marketing exclusivity.
Our
business strategy includes the development of product candidates for the treatment of diseases, which may be eligible for FDA or EMA
orphan drug designation. Regulatory authorities in some jurisdictions, including the United States and European Union, may designate
drugs or biologics for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug
as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer
than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there
is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In order to obtain
orphan drug designation, the request must be made before submitting an NDA or BLA. In the United States, orphan drug designation entitles
a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers.
After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by
the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
If
a product that has orphan drug designation subsequently receives the first FDA approval of that particular product for the disease for
which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other
applications, including an NDA or BLA, to market the same drug or biologic for the same indication for seven years, except in limited
circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of
the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the
needs of patients with the disease or condition for which the drug was designated. As a result, even if one of our product candidates
receives orphan exclusivity, the FDA can still approve other drugs or biologics for use in treating the same indication or disease or
the same biologic for a different indication or disease during the exclusivity period. Furthermore, the FDA can waive orphan exclusivity
if we are unable to manufacture sufficient supply of our product or if a subsequent applicant demonstrates clinical superiority over
our product.
In
the European Union, the Committee for Orphan Medicinal Products of the EMA grants orphan drug designation to promote the development
of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition
affecting not more than five in 10,000 persons in the European Union (or where it is unlikely that the development of the medicine would
generate sufficient return to justify the investment) and for which no satisfactory method of diagnosis, prevention, or treatment is
authorized or, if a method exists, the product would be of significant benefit to those affected by the condition.
Although
we have received Orphan drug designation with respect to our proposed Rabies therapeutic from the U.S. FDA on November 24, 2014, there
can be no assurance that will be able to receive orphan drug designation with respect to the European Medicines Agency for our Rabies
therapeutics or that we will be able to receive Orphan Drug Designation in the US or Europe with respect to any of our other therapeutics.
Even
if we obtain regulatory approval for a product candidate, we will be subject to ongoing regulatory obligations and continued regulatory
review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements
or experience unanticipated problems with our product candidates.
If
any of our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging,
storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and
other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign
regulatory authorities.
Manufacturers
and manufacturers’ facilities are required to comply with extensive requirements imposed by the FDA and comparable foreign regulatory
authorities, including ensuring that quality control and manufacturing procedures conform to current good manufacturing practices, or
other applicable, regulations. As such, we will be subject to continual review and inspections to assess compliance with and adherence
to commitments made in any NDA, BLA or marketing authorization application, or “MAA.” Accordingly, we and others with whom
we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production and
quality control.
Any
regulatory approvals that we may receive for our product candidates will be subject to limitations on the approved indicated uses for
which the product may be marketed and promoted or to the conditions of approval, or contain requirements for potentially costly post-marketing
testing, including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. We will be required
to report certain adverse reactions and production problems, if any, to the FDA and comparable foreign regulatory authorities. Any new
legislation addressing drug safety issues could result in delays in product development or commercialization, or increased costs to assure
compliance.
The
FDA and other agencies, including the Department of Justice, closely regulate and monitor the post-approval marketing, labeling, advertising
and promotion of products to ensure that they are manufactured, marketed and distributed only for the approved indications and in accordance
with the provisions of the approved label. We will have to comply with requirements concerning advertising and promotion for our products.
Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must
be consistent with the information in the product’s approved label. As such, we may not promote our products for indications or
uses for which they do not have approval.
The
holder of an approved NDA, BLA or MAA must submit new or supplemental applications and obtain approval for certain changes to the approved
product, product labeling, or manufacturing process. We could also be asked to conduct post-marketing clinical trials to verify the safety
and efficacy of our products in general or in specific patient subsets. If original marketing approval was obtained via the accelerated
approval pathway, we could be required to conduct a successful post-marketing clinical trial to confirm clinical benefit for our products.
An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of marketing approval.
If
a regulatory agency discovers previously unknown problems with a product, such as adverse events or AEs of unanticipated severity or
frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of
a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the
market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:
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issue
warning letters that would result in adverse publicity; |
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impose
civil or criminal penalties; |
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suspend
or withdraw regulatory approvals; |
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suspend
any of our ongoing clinical trials; |
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refuse
to approve pending applications or supplements to approved applications submitted by us; |
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impose
restrictions on our operations, including closing our CMOs’ facilities; |
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seize
or detain products; or |
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require
a product recall. |
Any
government investigation of alleged violations of law could require us to expend significant time and resources in response, and could
generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability
to commercialize and generate revenue from our products. If regulatory sanctions are applied or if regulatory approval is withdrawn,
the value of our company and our operating results will be adversely affected.
The
FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could
prevent, limit or delay regulatory approval of our product candidates.
We
also 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.
The
FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
If
any of our product candidates are approved and we are found to have improperly promoted off-label uses of those products, we may become
subject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about
prescription products, if approved. In particular, while FDA permits the dissemination of truthful and non-misleading information about
an approved product, a manufacturer may not promote a product for uses that are not approved by the FDA or such other regulatory agencies
as reflected in the product’s approved labeling. If we are found to have promoted such off-label uses, we may become subject to
significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion
of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter
into consent decrees, corporate integrity agreements or permanent injunctions under which specified promotional conduct must be changed
or curtailed. If we cannot successfully manage the promotion of our product candidates, if approved, we could become subject to significant
liability, which would materially adversely affect our business and financial condition.
Risks
Related to Reliance on Third Parties
We
expect to rely on third parties to conduct our clinical trials and all or most aspects of our research and preclinical testing, and those
third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research, or testing.
We
currently rely and expect to continue to rely on third parties, such as subject matter experts, clinical research organizations or CROs,
clinical data management organizations, medical institutions, and clinical investigators, to conduct all or most aspects of research
and preclinical testing and clinical trials. Any of these third parties may terminate their engagements with us or be unable to fulfill
their contractual obligations. If any of our relationships with these third parties terminate, we may not be able to enter into arrangements
with alternative third parties on commercially reasonable terms, or at all. If we need to enter into alternative arrangements, it would
delay product development activities.
Our
reliance on these third parties for research and development activities reduces control over these activities but does not relieve us
of our responsibilities. For example, we remain responsible for ensuring that each of our respective clinical trials is conducted in
accordance with the general investigational plan and protocols for the trial and applicable legal, regulatory, and scientific standards,
and our reliance on third parties does not relieve us of our regulatory responsibilities. In addition, the FDA and comparable foreign
regulatory authorities require compliance with good clinical practice regulations (GCPs) for conducting, recording, and reporting the
results of clinical trials to assure that data and reported results are credible, reproducible and accurate and that the rights, integrity,
and confidentiality of trial participants are protected. Regulatory authorities enforce these GCPs through periodic inspections of trial
sponsors, principal investigators, and trial sites. If we or any of these third parties fail to comply with applicable GCP regulations,
some or all of the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory
authorities may require us to perform additional nonclinical or clinical trials or to enroll additional patients before approving our
marketing applications. We cannot be certain that, upon inspection, such regulatory authorities will determine that any of our clinical
trials complies with the GCP regulations. For any violations of laws and regulations during the conduct of clinical trials, we could
be subject to untitled and warning letters or enforcement action that may include civil penalties up to and including criminal prosecution.
We also are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored
database within certain timeframes. Failure to do so can result in fines, adverse publicity, and civil and criminal sanctions.
If
these third parties do not successfully carry out their contractual duties, meet expected deadlines, or conduct clinical trials in accordance
with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals
for any product candidates we may develop and will not be able to, or may be delayed in our efforts to, successfully commercialize our
medicines. Our failure or the failure of these third parties to comply applicable regulatory requirements or our stated protocols could
also subject us to enforcement action.
We
also expect to rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on
the part of our distributors could delay clinical development or marketing approval of any product candidates we may develop or commercialization
of our medicines, producing additional losses and depriving us of potential product revenue.
We
may rely entirely on third parties for the manufacturing of our product candidates or other product candidates that we may develop for
preclinical studies and clinical trials and expect to continue to do so for commercialization. Our business could be harmed if those
third parties fail to provide us with sufficient quantities of drug product, or fail to do so at acceptable quality levels or prices.
We
do not currently have, nor do we plan to acquire, the infrastructure or capability internally to manufacture drug supplies for our ongoing
clinical trials or any future clinical trials that we may conduct, and we lack the resources to manufacture any product candidates on
a commercial scale. We rely, and expect to continue to rely, on third-party manufacturers to produce our current product candidates or
other product candidates that we may identify for clinical trials, as well as for commercial manufacture if any product candidates that
receive marketing approval. Although we generally do not begin a clinical trial unless we believe we have a sufficient supply of a product
candidate to complete the trial, any significant delay or discontinuity in the supply of a product candidate, or the raw material components
thereof, for an ongoing clinical trial due to the need to replace a third-party manufacturer could considerably delay the clinical development
and potential regulatory approval of our product candidates, which could harm our business and results of operations. We also expect
to rely primarily on third parties for the manufacturing of commercial supply of our product candidates, if approved.
We
may be unable to identify and appropriately qualify third-party manufacturers or establish agreements with third-party manufacturers
or do so on acceptable terms. This is especially true in the time of COVID where much of the world’s biomanufacturing capacity
is committed to creating vaccines and vaccine related essential materials. Even if we are able to establish agreements with third-party
manufacturers, reliance on third-party manufacturers entails additional risks, including:
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reliance
on the third party for sourcing of raw materials, components, and such other goods as may be required for execution of its manufacturing
processes and the oversight by the third party of its suppliers; |
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reliance
on the third party for regulatory compliance and quality assurance for the manufacturing activities each performs; |
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the
possible breach of the manufacturing agreement by the third party; |
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the
possible misappropriation of proprietary information, including trade secrets and know-how; and |
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the
possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us. |
Furthermore,
all of our contract manufacturing organizations (CMO)s are engaged with other companies to supply and/or manufacture materials or products
for such companies, which exposes our manufacturers to regulatory risks for the production of such materials and products. The facilities
used by our contract manufacturers to manufacture our product candidates are subject to review by the FDA pursuant to inspections that
will be conducted after we submit an NDA or BLA to the FDA. We do not control the manufacturing process of, and are completely dependent
on, our contract manufacturing partners for compliance with the regulatory requirements, known as current good manufacturing practice,
or cGMP, requirements for manufacture of drug and biologic products. If our contract manufacturers cannot successfully manufacture material
that conforms to our specifications and the strict regulatory requirements of the FDA or others, we will not be able to secure or maintain
regulatory approval for our product candidates manufactured at these manufacturing facilities. In addition, we have no control over the
ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or
a comparable foreign regulatory agency does not approve these facilities for the manufacture of our product candidates or if any agency
withdraws its approval in the future, we may need to find alternative manufacturing facilities, which would negatively impact the ability
to develop, obtain regulatory approval for or market our product candidates, if approved.
Our
product candidates may compete with other product candidates and marketed drugs for access to manufacturing facilities. Any performance
failure on the part of our existing or future manufacturers could delay clinical development, marketing approval or commercialization.
Our current and anticipated future dependence upon others for the manufacturing of our product candidates may adversely affect our future
profit margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.
If
the contract manufacturing facilities on which we rely do not continue to meet regulatory requirements or are unable to meet our supply
demands, our business will be harmed.
All
entities involved in the preparation of product candidates for clinical trials or commercial sale, including our existing CMOs for all
of our product candidates, are subject to extensive regulation. Components of a finished therapeutic product approved for commercial
sale or used in late-stage clinical trials must be manufactured in accordance with cGMP, or similar regulatory requirements outside the
United States. These regulations govern manufacturing processes and procedures, including recordkeeping, and the implementation and operation
of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production
processes can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of our product candidates.
Our failure, or the failure of third-party 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, license revocation,
suspension of production, seizures or recalls of product candidates or marketed drugs, operating restrictions and criminal prosecutions,
any of which could significantly and adversely affect clinical or commercial supplies of our product candidates.
We
or our CMOs must supply all necessary documentation in support of an NDA, BLA or MAA on a timely basis and must adhere to regulations
enforced by the FDA and other regulatory agencies through their facilities inspection program. Some of our CMOs have never produced a
commercially approved pharmaceutical product and therefore have not obtained the requisite regulatory authority approvals to do so. The
facilities and quality systems of some or all of our third-party contractors must pass a pre-approval inspection for compliance with
the applicable regulations as a condition of regulatory approval of our product candidates or any of our other potential products. In
addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of our
product candidates or our other potential products or the associated quality systems for compliance with the regulations applicable to
the activities being conducted. Although we oversee the CMOs, we cannot control the manufacturing process of, and are completely dependent
on, our CMO partners for compliance with the regulatory requirements. If these facilities do not pass a pre-approval plant inspection,
regulatory approval of the products may not be granted or may be substantially delayed until any violations are corrected to the satisfaction
of the regulatory authority, if ever.
The
regulatory authorities also may, at any time following approval of a product for sale, audit the manufacturing facilities of our third-party
contractors. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product
specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may
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 study or commercial sales 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.
Additionally,
if supply from one approved manufacturer is interrupted, an alternative manufacturer would need to be qualified through an NDA, BLA supplement
or MAA variation, or equivalent foreign regulatory filing, which could result in further delay. The regulatory agencies may also require
additional studies if a new manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial costs
and is likely to result in a delay in our desired clinical and commercial timelines.
These
factors could cause us to incur higher costs and could cause the delay or termination of clinical trials, regulatory submissions, required
approvals, or commercialization of our product candidates. Furthermore, if our suppliers fail to meet contractual requirements and we
are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical trials
may be delayed or we could lose potential revenue.
Collaborative
relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance
of financial return.
We
anticipate relying upon strategic collaborations for marketing and commercializing our existing product candidates, and we may rely even
more on strategic collaborations for R&D of other product candidates. We may sell product offerings through strategic partnerships
with pharmaceutical and biotechnology companies. If we are unable to establish or manage such strategic collaborations on terms favorable
to us in the future, our R&D efforts and potential to generate revenue may be limited.
If
we enter into R&D collaborations during the early phases of product development, success will in part depend on the performance of
research collaborators. We will not directly control the amount or timing of resources devoted by research collaborators to activities
related to product candidates. Research collaborators may not commit sufficient resources to our R&D programs. If any research collaborator
fails to commit sufficient resources, the preclinical or clinical development programs related to the collaboration could be delayed
or terminated. Also, collaborators may pursue existing or other development-stage products or alternative technologies in preference
to those being developed in collaboration with us. Finally, if we fail to make required milestone or royalty payments to collaborators
or to observe other obligations in agreements with them, the collaborators may have the right to terminate or stop performance of those
agreements.
Establishing
strategic collaborations is difficult and time-consuming. Our discussions with potential collaborators may not lead to the establishment
of collaborations on favorable terms, if at all. Potential collaborators may reject collaborations based upon their assessment of our
financial, regulatory or intellectual property position. In addition, there have been a significant number of recent business combinations
among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Even if we successfully
establish new collaborations, these relationships may never result in the successful development or commercialization of product candidates
or the generation of sales revenue. To the extent that we enter into collaborative arrangements, the related product revenues are likely
to be lower than if we directly marketed and sold products. Such collaborators may also consider alternative product candidates or technologies
for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one
with us for any future product candidate.
Management
of our relationships with collaborators will require:
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significant
time and effort from our management team; |
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coordination
of our marketing and R&D programs with the marketing and R&D priorities of our collaborators; and |
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effective
allocation of our resources to multiple projects. |
We
are parties to and may seek to enter into additional collaborations, licenses and other similar arrangements and may not be successful
in maintaining existing arrangements or entering into new ones, and even if we are, we may not realize the benefits of such relationships.
The
success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborations are
subject to numerous risks, which may include risks that:
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collaborators
may have significant discretion in determining the efforts and resources that they will apply to collaborations; |
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collaborators
may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization
programs based on clinical trial results, changes in their strategic focus due to their acquisition of competitive products or their
internal development of competitive products, availability of funding or other external factors, such as a business combination that
diverts resources or creates competing priorities; |
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collaborators
may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial, abandon a product candidate,
repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; |
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collaborators
could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product
candidates; |
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a
collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to
or otherwise not perform satisfactorily in carrying out these activities; |
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we
could grant exclusive rights to our collaborators that would prevent us from collaborating with others; |
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collaborators
may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information
in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary
information or expose us to potential liability; |
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disputes
may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of
our current or future product candidates or that results in costly litigation or arbitration that diverts management attention and
resources; |
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collaborations
may be terminated, which may result in a need for additional capital to pursue further development or commercialization of the applicable
current or future product candidates; |
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collaborators
may own or co-own intellectual property covering products that result from our collaboration with them, and in such cases, we would
not have the exclusive right to develop or commercialize such intellectual property; |
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disputes
may arise with respect to the ownership of any intellectual property developed pursuant to our collaborations; and |
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a
collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in
civil or criminal proceedings. |
Additionally,
we may seek to enter into additional collaborations, joint ventures, licenses and other similar arrangements for the development or commercialization
of our product candidates, due to capital costs required to develop or commercialize the product candidate or manufacturing constraints.
We may not be successful in our efforts to establish such collaborations for our product candidates because our research and development
pipeline may be insufficient, our product candidates may be deemed to be at too early of a stage of development for collaborative effort
or third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy or significant
commercial opportunity. In addition, we face significant competition in seeking appropriate strategic partners, and the negotiation process
can be time consuming and complex.
Further,
any future collaboration agreements may restrict us from entering into additional agreements with potential collaborators. We cannot
be certain that, following a strategic transaction or license, we will achieve an economic benefit that justifies such transaction.
Even
if we are successful in our efforts to establish such collaborations, the terms that we agree upon may not be favorable to us, and we
may not be able to maintain such collaborations if, for example, development or approval of a product candidate is delayed, the safety
of a product candidate is questioned or sales of an approved product candidate are unsatisfactory.
In
addition, any potential future collaborations may be terminable by our strategic partners, and we may not be able to adequately protect
our rights under these agreements. Furthermore, strategic partners may negotiate for certain rights to control decisions regarding the
development and commercialization of our product candidates, if approved, and may not conduct those activities in the same manner as
we do. Any termination of collaborations we enter into in the future, or any delay in entering into collaborations related to our product
candidates, could delay the development and commercialization of our product candidates and reduce their competitiveness if they reach
the market, which could have a material adverse effect on our business, financial condition and results of operations.
Risks
Related to our Intellectual Property
If
we are unable to obtain and maintain sufficient intellectual property for our product candidates that we may identify, or if the scope
of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize product candidates
similar or identical to ours, and our ability to successfully commercialize some product candidates that we may pursue may be impaired.
As
is the case with other pharmaceutical and biopharmaceutical companies, our success depends in large part on our ability, or our licensors,
to obtain and maintain protection of the intellectual property that we may license or own solely and jointly with others, particularly
patents, in the United States and other countries with respect to our product candidates and technology. We seek to protect our proprietary
position by filing patent applications in the United States and abroad related to product candidates that we may identify.
Obtaining
and enforcing pharmaceutical and biopharmaceutical patents is costly, time consuming and complex, and we may not be able to file and
prosecute necessary or desirable patent applications, or maintain, enforce and license patents that may issue from such patent applications,
at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and
development output before it is too late to obtain patent protection. We may not have the right to control the preparation, filing and
prosecution of patent applications, or to maintain the rights to patents licensed from third parties. Therefore, these patents and applications
may not be prosecuted and enforced in a manner consistent with the best interests of our business.
The
patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal, technological and
factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect
our rights to the same extent as the laws of the United States, or vice versa. Further, we may not be aware of all third-party intellectual
property rights potentially relating to our licensed product candidates. 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 know with certainty whether if we make an inventions claimed
in our future patents or pending patent applications, or that we are the first to file for patent protection of such inventions. Furthermore,
the scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s
prosecution history and can involve other factors such as expert opinion. Our analysis of these issues, including interpreting the relevance
or the scope of claims in a future or licensed patent or a pending application, determining applicability of such claims to our proprietary
technologies or product candidates, predicting whether a third party’s pending patent application will issue with claims of relevant
scope, and determining the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which
may negatively impact our ability to develop and market our product candidates. We do not always conduct independent reviews of pending
patent applications of and patents issued to third parties. As a result, the issuance, scope, validity, enforceability and commercial
value of our licensed patent rights are highly uncertain. Our pending and future patent applications may not result in patents being
issued that protect our product candidates, in whole or in part, or which effectively prevent others from commercializing competitive
product candidates. Even if our future or licensed 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 product candidates in a non-infringing manner.
Our
ability to enforce licensed patent and future patent rights also depends on our ability to detect infringement. It may be difficult to
detect infringers who do not advertise the components or methods that are used in connection with their products and services. Moreover,
it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product
or service. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded if we were to prevail may not
be commercially meaningful. If we initiate lawsuits to protect or enforce our licensed or future patents, or litigate against third-party
claims, such proceedings would be expensive and would divert the attention of our management and technical personnel. Such proceedings
could also provoke third parties to assert claims against us, including that some or all of the claims in one or more of our patents
are invalid or otherwise unenforceable.
In
addition, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our licensed or future
patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity
or freedom to operate 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 product candidates to ours, or limit the duration of the patent
protection of our product candidates. Given the amount of time required for the development, testing and regulatory review of new product
candidates, licensed or future patents protecting such candidates might expire before or shortly after such candidates are commercialized.
As a result, our intellectual property portfolio may not provide us with sufficient rights to exclude others from commercializing drugs
similar or identical to ours.
Our
rights to develop and commercialize our product candidates are subject in part to the terms and conditions of licenses granted to us
by others, and the patent protection, prosecution and enforcement for some of our product candidates may be dependent on our licensors.
We
currently are reliant upon licenses of certain intellectual property rights and proprietary technology from third parties that are important
or necessary to the development of our proprietary technology, including technology related to our product candidates. These licenses,
and other licenses we may enter into in the future, may not provide adequate rights to use such intellectual property rights and proprietary
technology in all relevant fields of use or in all territories in which we may wish to develop or commercialize technology and product
candidates in the future. Licenses to additional third-party proprietary technology or intellectual property rights that may be required
for our development programs may not be available in the future or may not be available on commercially reasonable terms. In that event,
we may be required to expend significant time and resources to redesign our proprietary technology or product candidates or to develop
or license replacement technology, which may not be feasible on a technical or commercial basis. If we are unable to do so, we may not
be able to develop and commercialize technology and product candidates in fields of use and territories for which we are not granted
rights pursuant to such licenses, which could harm our competitive position, business, financial condition, results of operations and
prospects significantly.
In
some circumstances, we may not have the right to control the preparation, filing, prosecution and enforcement of patent applications,
or to maintain the patents, covering technology that we license from third parties. In addition, some of our agreements with our licensors
require us to obtain consent from the licensor before we can enforce patent rights, and our licensor may withhold such consent or may
not provide it on a timely basis. Therefore, we cannot be certain that our licensors or collaborators will prosecute, maintain, enforce
and defend such intellectual property rights in a manner consistent with the best interests of our business, including by taking reasonable
measures to protect the confidentiality of know-how and trade secrets, or by paying all applicable prosecution and maintenance fees related
to intellectual property registrations for any of our product candidates. We also cannot be certain that our licensors have drafted or
prosecuted the patents and patent applications licensed to us in compliance with applicable laws and regulations, which may affect the
validity and enforceability of such patents or any patents that may issue from such applications. This could cause us to lose rights
in any applicable intellectual property that we in-license, and as a result our ability to develop and commercialize product candidates
may be adversely affected and we may be unable to prevent competitors from making, using and selling competing products.
In
addition, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject
to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights. In addition, while we
cannot currently determine the amount of the royalty obligations we would be required to pay on sales of future products, if any, the
amounts may be significant. The amount of our future royalty obligations will depend on the technology and intellectual property we use
in product candidates that we successfully develop and commercialize, if any. Therefore, even if we successfully develop and commercialize
product candidates, we may be unable to achieve or maintain profitability. In addition, we may seek to obtain additional licenses from
our licensors and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more
favorable to the licensors, including by agreeing to terms that could enable third parties (potentially including our competitors) to
receive licenses to a portion of the intellectual property rights that are subject to our existing licenses. Any of these events could
have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.
If
we fail to comply with the obligations of our licensing agreements or these agreements are terminated or we otherwise experience disruptions
to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.
We
are party to various agreements that we depend on to operate our business, and our rights to use currently licensed intellectual property,
or intellectual property to be licensed in the future, are or will be subject to the continuation of and our compliance with the terms
of these agreements. Such license agreements may impose, and we expect that future license agreements will impose, various development,
diligence, commercialization, and other obligations on us. For example, we may be required to use commercially reasonable efforts to
engage in various development and commercialization activities with respect to licensed products, and must satisfy specified milestone
and royalty payment obligations. In spite of our efforts, our licensors might conclude that we have materially breached our obligations
under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop
and commercialize products and technology covered by these license agreements. In addition, certain provisions in our license agreements
may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow
what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be
our financial or other obligations under the agreement, either of which could have a material adverse effect on our business, financial
condition, results of operations and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair
our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop
and commercialize the affected product candidates, which could have a material adverse effect on our competitive position, business,
financial conditions, results of operations and prospects.
Third-party
claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
Our
commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. However, our
research, development and commercialization activities may be subject to claims that we infringe or otherwise violate patents or other
intellectual property rights owned or controlled by third parties. There is a substantial amount of litigation, both within and outside
the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including
patent infringement lawsuits, interferences, oppositions and inter partes reexamination proceedings before the USPTO, and corresponding
foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist
in the fields in which we are pursuing development candidates. As the biotechnology and pharmaceutical industries expand and more patents
are issued, the risk increases that some of our product candidates that we may identify may be subject to claims of infringement of the
patent rights of third parties.
Patent
terms may be inadequate to protect our competitive position on product candidates for an adequate amount of time.
Patents
have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
20 years from its earliest U.S. non-provisional or international patent application filing date. Various extensions may be available,
but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once
the patent life has expired, we may be open to competition from competitive products, including generics or biosimilars. 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. As a result, our owned and licensed patent portfolio may not provide
us with sufficient rights to exclude others from commercializing products similar or identical to ours.
If
we or our licensors are not able to obtain patent term extension or non-patent exclusivity in the United States under the Hatch-Waxman
Act and in foreign countries under similar legislation, thereby potentially extending the marketing exclusivity term of our product candidates,
our business may be materially harmed.
Depending
upon the timing, duration and specifics of FDA marketing approval of our product candidates, one of the U.S. patents covering each of
such product candidates or the use thereof may be eligible for up to five years of patent term extension under the Hatch-Waxman Act.
The Hatch-Waxman Act allows a maximum of one patent to be extended per FDA approved product as compensation for the patent term lost
during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years
from the date of product approval and only those claims covering such approved drug product, a method for using it or a method for manufacturing
it may be extended. Patent term extension also may be available in certain foreign countries upon regulatory approval of our product
candidates. Nevertheless, neither we nor our licensees may not be granted patent term extension either in the United States or in any
foreign country because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing
to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable
requirements. Moreover, the term of extension, as well as the scope of patent protection during any such extension, afforded by the governmental
authority could be less than we request.
If
we or our licensors are unable to obtain patent term extension or restoration, or the term of any such extension is less than we request,
the period during which we will have the right to exclusively market our product may be shortened and our competitors may obtain approval
of competing products following our patent expiration sooner, and our revenue could be reduced, possibly materially.
If
we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected
and our business would be harmed.
We
seek to protect our confidential proprietary information, in part, by confidentiality agreements and invention assignment agreements
with our employees, consultants, scientific advisors, contractors and collaborators. These agreements are designed to protect our proprietary
information. However, we cannot be certain that such agreements have been entered into with all relevant parties, and we cannot be certain
that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain
access to our trade secrets or independently develop substantially equivalent information and techniques. For example, any of these parties
may breach the agreements and disclose proprietary information, including trade secrets, and we may not be able to obtain adequate remedies
for such breaches. We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining
physical security of our premises and physical and electronic security of our information technology systems, but it is possible that
these security measures could be breached. If any of our confidential proprietary information were to be lawfully obtained or independently
developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete with
us, which could harm our competitive position.
Unauthorized
parties may also attempt to copy or reverse engineer certain aspects of our products that we consider proprietary. We may not be able
to obtain adequate remedies in the event of such unauthorized use. Enforcing a claim that a party illegally disclosed or misappropriated
a trade secret can be difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and
outside the United States are less willing or unwilling to protect trade secrets. Trade secrets will also over time be disseminated within
the industry through independent development, the publication of journal articles and the movement of personnel skilled in the art from
company to company or academic to industry scientific positions. Though our agreements with third parties typically restrict the ability
of our advisors, employees, collaborators, licensors, suppliers, third-party contractors and consultants to publish data potentially
relating to our trade secrets, our agreements may contain certain limited publication rights. In addition, if any of our trade secrets
were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using
that technology or information to compete with us, which could harm our competitive position. Despite employing the contractual and other
security precautions described above, the need to share trade secrets increases the risk that such trade secrets become known by our
competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements.
If any of these events occurs or if we otherwise lose protection for our trade secrets, the value of this information may be greatly
reduced and our competitive position, business, financial condition, results of operations, and prospects would be harmed.
We
may become involved in lawsuits to protect or enforce our licensed patents or other intellectual property, which could be expensive,
time consuming and unsuccessful.
Competitors
may infringe on our licensed patents or other intellectual property. If we were to initiate legal proceedings against a third party to
enforce a patent covering one or more of our product candidates, the defendant could counterclaim that the patent covering our product
candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or
unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements,
including novelty, non-obviousness, written description or enablement. Grounds for an unenforceability assertion could be an allegation
that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during
prosecution. The outcome following legal assertions of invalidity and unenforceability is unpredictable. Interference or derivation proceedings
provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect
to our licensed patents or patent applications. An unfavorable outcome could require us to cease using the related technology or to attempt
to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on
commercially reasonable terms or at all, or if a non-exclusive license is offered and our competitors gain access to the same technology.
Our defense of litigation or interference or derivation proceedings may fail and, even if successful, may result in substantial costs
and distract our management and other employees. In addition, the uncertainties associated with litigation could have a material adverse
effect on our ability to raise the funds necessary to continue clinical trials, continue research programs, license necessary technology
from third parties, or enter into development partnerships that would help us bring product candidates to market. 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 this type of 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 our Common Stock.
We
may be subject to claims challenging the inventorship of our patents and other intellectual property.
Our
agreements with employees and our personnel policies provide that any inventions conceived by an individual in the course of rendering
services to us shall be our exclusive property. Although our policy is to have all such individuals complete these agreements, we may
not obtain these agreements in all circumstances, and individuals with whom we have these agreements may not comply with their terms.
The assignment of intellectual property may not be automatic upon the creation of an invention and despite such agreement, such inventions
may become assigned to third parties. In the event of unauthorized use or disclosure of our trade secrets or proprietary information,
these agreements, even if obtained, may not provide meaningful protection, particularly for our trade secrets or other confidential information.
We
or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in our owned or
in-licensed patents, trade secrets, or other intellectual property as an inventor or co-inventor. For example, we or our licensors may
have inventorship disputes arise from conflicting obligations of employees, consultants or others who are involved in developing our
product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or our or our licensors’
ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we or our licensors fail in defending
any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership
of, or right to use, intellectual property that is important to our product candidates. Even if we are successful in defending against
such claims, litigation could result in substantial costs and be a distraction to management and other employees.
Any
of the foregoing could have a material adverse effect on our competitive position, business, financial condition, results of operations
and prospects.
Issued
patents covering our product candidates could be found invalid or unenforceable if challenged in court.
If
we or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering one or more of our
product candidates, the defendant could counterclaim that the patent covering the relevant product candidate is invalid and/or unenforceable.
In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds
for a validity challenge could be an alleged failure to meet any of several statutory requirements, including novelty, non-obviousness,
written description or enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution
of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may also
raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms
include re-examination, post grant review, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings
could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates. The outcome following
legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be
certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant
were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent
protection on our product candidates. Such a loss of patent protection would have a material adverse impact on our business.
We
may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information
of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
As
is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at universities or other
biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees,
consultants and independent contractors 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 our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed
intellectual property, including trade secrets or other proprietary information, of any of our employee’s former employer or other
third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying
monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if
we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and
other employees.
Obtaining
and maintaining our patent protection depends on our licensing partner’s compliance with various procedural, document submission,
fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated
for non-compliance with these requirements.
Periodic
maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid
to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents
and/or applications. Although there are systems developed to remind patent holders when to pay these fees, as well as outside firms and
counsel that pay these fees due to non-U.S. patent agencies, we cannot guarantee that our licensors have such systems and procedures
in place to pay such fees.
We
may not be able to protect 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, and
our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In
addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws
in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside
the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.
Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and
may also export infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United
States. 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. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate
to obtain a significant commercial advantage from the intellectual property that we develop or license.
Risks
Related to Commercialization
Even
if any product candidates we develop receive marketing approval, they 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 our product candidates will depend upon their degree of market acceptance by physicians, patients, third-party
payors, and others in the medical community. Even if any product candidates we may develop receive marketing approval, they may nonetheless
fail to gain sufficient market acceptance by physicians, patients, healthcare payors, and others in the medical community. The degree
of market acceptance of any product candidates we may develop, if approved for commercial sale, will depend on a number of factors, including:
| |
● |
the
efficacy and safety of such product candidates as demonstrated in pivotal clinical trials and published in peer-reviewed journals; |
| |
● |
the
potential and perceived advantages compared to alternative treatments, including any similar generic treatments; |
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● |
the
ability to offer these products for sale at competitive prices; |
| |
● |
the
ability to offer appropriate patient access programs, such as co-pay assistance; |
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● |
convenience
and ease of dosing and administration compared to alternative treatments; |
| |
● |
the
clinical indications for which the product candidate is approved by FDA or comparable regulatory agencies; |
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● |
product
labeling or product insert requirements of the FDA or other comparable foreign regulatory authorities, including any limitations,
contraindications or warnings contained in a product’s approved labeling; |
| |
● |
restrictions
on how the product is distributed; |
| |
● |
the
timing of market introduction of competitive products; |
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● |
publicity
concerning these products or competing products and treatments; |
| |
● |
the
strength of marketing and distribution support; |
| |
● |
favorable
third-party coverage and sufficient reimbursement; and |
| |
● |
the
prevalence and severity of any side effects or AEs. |
Sales
of medical products also depend on the willingness of physicians to prescribe the treatment, which is likely to be based on a determination
by these physicians that the products are safe, therapeutically effective and cost effective. In addition, the inclusion or exclusion
of products from treatment guidelines established by various physician groups and the viewpoints of influential physicians can affect
the willingness of other physicians to prescribe the treatment. We cannot predict whether physicians, physicians’ organizations,
hospitals, other healthcare providers, government agencies or private insurers will determine that our product is safe, therapeutically
effective and cost effective as compared with competing treatments. If any product candidates we develop do not achieve an adequate level
of acceptance, we may not generate significant product revenue, and we may not become profitable.
If,
in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market
any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved.
We
do not have a sales or marketing infrastructure and have little experience in the sale, marketing, or distribution of pharmaceutical
products. To achieve commercial success for any approved product for which we retain sales and marketing responsibilities, we must either
develop a sales and marketing organization or outsource these functions to third parties. In the future, we may choose to build a focused
sales, marketing, and commercial support infrastructure to market and sell our product candidates, if and when they are approved. We
may also elect to enter into collaborations or strategic partnerships with third parties to engage in commercialization activities with
respect to selected product candidates, indications or geographic territories, including territories outside the United States, although
there is no guarantee we will be able to enter into these arrangements even if the intent is to do so. If we do not establish commercialization
capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our
product candidates, if approved.
The
insurance coverage and reimbursement status of newly approved products is uncertain. Our product candidates may become subject to
unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would
harm our business. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our
ability to market those products and decrease our ability to generate revenue.
The
regulations that govern marketing approvals, pricing, coverage, and reimbursement for new drugs vary widely from country to country.
In the United States, recently enacted legislation may significantly change the approval requirements in ways that could involve additional
costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed.
In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets,
prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result,
we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay our commercial
launch of the product, possibly for lengthy time periods, and negatively impact the revenue we are able to generate from the sale of
the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates,
even if we receive marketing approval, which would have an adverse material impact on our operations and financial resources.
If
we fail to comply with healthcare laws, we could face substantial penalties and our business, operations and financial conditions could
be adversely affected.
Healthcare
providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription
of pharmaceutical products. Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable
fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal
False Claims Act, which may constrain the business or financial arrangements and relationships through which such companies sell, market
and distribute pharmaceutical products. 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 ownership, pricing, discounting, marketing
and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Failure
to comply with these laws could result in regulatory or civil action against us which could have a material adverse effect on our operations
and financial condition.
Failure
to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil
or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.
We
and any potential collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations
that address privacy and data security). In the United States, numerous federal and state laws and regulations, including federal health
information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer
protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of
health-related and other personal information could apply to our operations or the operations of our collaborators. In addition, we may
obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject
to privacy and security requirements under HIPAA, as amended by HITECH. Depending on the facts and circumstances, we could be subject
to civil, criminal, and administrative penalties if we knowingly obtain, use, or disclose individually identifiable health information
maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. Failure to comply with these laws and
regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private
litigation, and/or adverse publicity and could negatively affect our operating results and business.
European
data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.
In
the event we decide to conduct clinical trials or continue to enroll subjects in our ongoing or future clinical trials in the European
Union, we may be subject to additional privacy restrictions. The collection and use of personal health data in the European Union is
governed by the provisions of the General Data Protection Regulation 2016/679, or GDPR. This directive imposes several requirements relating
to the consent of the individuals to whom the personal data relates, the information provided to the individuals, notification of data
processing obligations to the competent national data protection authorities and the security and confidentiality of the personal data.
The GDPR also imposes strict rules on the transfer of personal data out of the European Union to the United States. Failure to comply
with the requirements of the Data Protection Directive, which governs the collection and use of personal health data in the European
Union, the GDPR, and the related national data protection laws of the European Union Member States may result in fines and other administrative
penalties. The GDPR introduced new data protection requirements in the European Union and substantial fines for breaches of the data
protection rules. The GDPR regulations may impose additional responsibility and liability in relation to personal data that we process
and we may be required to put in place additional mechanisms ensuring compliance with these and/or new data protection rules which may
result in a negative effect to our business and financial results. This may be onerous and adversely affect our business, financial
condition, prospects and results of operations.
Healthcare
legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
The
United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system
that could prevent or delay marketing approval of our product candidates or any future product candidates, restrict or regulate post-approval
activities and affect our ability to profitably sell any product for which we obtain marketing approval. Changes in regulations, statutes
or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing
arrangements; (ii) additions or modifications to product labelling; (iii) the recall or discontinuation of our products; or (iv)
additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business.
We
face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors
may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may negatively
impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition.
The
development and commercialization of new drug products is highly competitive. We may face competition with respect to any product candidates
that we seek to develop or commercialize in the future from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology
companies worldwide. 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. There are a number of large pharmaceutical and biotechnology companies that are currently pursuing the development
and commercialization of products for the treatment of the indications that our key drivers are pursuing. If any of these competitors
or competitors for our product candidates receive FDA approval before we do, our product candidates would not be the first treatment
on the market, and our market share may be limited. In addition to competition from other companies targeting our target indications,
any products we may develop may also face competition from other types of therapies. Many of our current or potential competitors, either
alone or with their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing,
preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do.
Risks
Related to this Offering and Our Common Stock and Warrants
We
have paid no dividends and we do not anticipate paying any cash dividends in the foreseeable.
We
have never paid cash dividends in the past, and currently do not intend to pay any cash dividends in the foreseeable future. We intend
to retain earnings, if any, to finance the development and expansion of our business. Our future dividend policy will be subject to the
discretion of our Board of Directors and will be contingent upon future earnings, if any, our financial condition, capital requirements,
general business conditions, and other factors. Therefore, we can give no assurance that any dividends of any kind will ever be paid
to holders of our Common Stock.
Investors
in this offering will experience immediate and substantial dilution in net tangible book value.
The
public offering price will be substantially higher than the net tangible book value per share of our outstanding shares of Common Stock.
As a result, investors in this offering will incur immediate dilution of $5.06 per share, based on the assumed public offering
price of $6.00 per share of Common Stock and Warrant. Investors in this offering will pay a price per share that substantially exceeds
the book value of our assets after subtracting our liabilities. See “Dilution” for a more complete description of how the
value of your investment will be diluted upon the completion of this offering.
The Warrants are speculative in nature.
The Warrants offered pursuant to this
prospectus 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 our Common Stock at a fixed price (subject to adjustment as
set forth in the Warrants) for a limited period of time. Specifically, commencing on the date of issuance, holders of the Warrants
may exercise their right to acquire the Common Stock and pay an exercise price equal to 150% of the public offering price of the
Units in this offering), prior to five (5) years from the date of issuance for the Warrants, after which date any unexercised
Warrants will expire and have no further value. Moreover, following this offering, the market value of the Warrants is uncertain and
there can be no assurance that the market value of the Warrants will equal or exceed their public offering price. There can be no
assurance that the market price of the Common Stock will ever equal or exceed the exercise price of the respective Warrants, and,
consequently, whether it will ever be profitable for holders of the Warrants to exercise the Warrants.
The Warrants will be subject to
redemption by the Company under certain conditions.
The Warrants will be subject to redemption at
a redemption price of $0.01 per Warrant commencing six (6) months from issuance subject to the condition that the volume
weighted average price of the Company’s Common Stock exceeds 200% of the initial exercise price for twenty (20) consecutive
trading days and subject to certain other conditions set forth in the Warrants. This redemption provision may reduce the value
of the Warrants because such redemption, if it occurs, will result in the holders no longer having the
opportunity to benefit from further increases in the price of our Common Stock.
You
may experience future dilution as a result of future equity offerings or the achievement of certain milestones pursuant to our
various licensing agreements.
To
the extent that we raise additional funds through the sale of equity or convertible debt securities, the issuance of such securities
will result in dilution to our stockholders. We may sell shares or other securities in any other offering at a price per share that is
less than the price per share paid by investors in this offering, and investors purchasing shares or other securities in the future could
have rights superior to existing stockholders. The price per share at which we sell additional shares of our common stock, or securities
convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by investors
in this offering. Additionally, we are a party to certain licensing agreement for our Rabies program with Mid-Atlantic BioTherapeutics,
Inc. whereby we will be required to issue (i) 16,250 shares of Common Stock upon the submission of an IND application to the FDA
that is accepted for our Rabies program and (ii) an additional 16,250 shares of Common Stock upon the successful completion of
the first Rabies clinical trial conducted pursuant to such IND application. Furthermore, pursuant to a separate licensing agreement for
our COVID-19 program with Mid-Atlantic BioTherapeutics, Inc. whereby we will be required to issue an additional 43,750 shares
of Common Stock upon the submission of an IND application to the FDA that is accepted for our COVID-19 program. If and when such shares
of Common Stock are issued pursuant to the terms of each respective license and the milestones thereunder, our shareholders will experience
immediate dilution upon such respective issuances.
Substantially all of our assets are secured
as collateral for repayment of a secured convertible promissory note. In the event we default on the terms of such convertible promissory
note, the lender will have the right to seize and sell the collateral.
On March 4, 2022, we issued a secured convertible
promissory note in aggregate principal of $1,142,857, in exchange for $1,000,000 in cash to Puritan Partners, LLC, an institutional investor.
The note has a maturity date of March 2, 2023, accrues interest at 12.5% annually, with interest payments to be made monthly. As security
for such indebtedness, we have pledged as collateral substantially all of our assets, including our intellectual property. Upon an occurrence
of an event of default under the note, the lender may enforce certain rights against us, including taking possession of substantially
all of our assets and selling them. Accordingly, any default would have a material adverse effect on our business, operating results,
and financial condition. While we intend to use certain of the proceeds from the sale of the Units pursuant to this Prospectus
to pay-off the note, there can be no guarantee that we will receive sufficient proceeds to do so. In the event that we are unable to
refinance or repay our indebtedness as it becomes due or upon an event of default, we may become insolvent and be unable to continue
operations.
You may experience substantial future dilution
upon the conversion of the secured convertible promissory note and exercise of the common stock purchase warrant issued in our March
2022 secured note offering.
If an event of default occurs under the secured
convertible promissory note issued in our March 2022 offering, the lender will have the right to convert the secured convertible note
into shares of our Common Stock at a price per share equal to the lowest trading price of our Common stock for the twenty (20) prior
trading days. In the event we default on the note, our shareholders may experience substantial dilution upon the lender electing to convert
the promissory note into Common Stock at a substantial discount to the market price.
Additionally, in connection with the issuance of
the secured convertible note, we issued the lender a warrant to purchase 57,142 shares of Common Stock at an exercise price of
$0.0001 and a term of five (5) years. Accordingly, the warrant holder initially had the right to purchase approximately four percent
(4%) of our issued and outstanding shares of Common Stock as of the date of this Prospectus for approximately $2,286. Additionally, the
warrant contains certain provisions that provide for an increase in the shares underlying the warrant upon the occurrence of an offering
of $10,000,000 or more in an offering of equity or debt securities at a price per share, which multiplied by 75% is less than $0.05 (subject
to splits, etc.). Upon an event of a default on our secured convertible promissory note, the exercise of this warrant, including any
adjustment to the warrant share amount, our shareholders will experience substantial dilution.
On August 18, 2022, the parties to this convertible
note agreed to an amendment of this note and accompanying transaction documents. The first principal repayment was amended to be due
on October 2, 2022, instead of September 1, 2022. We additionally amended the warrant to increase the number of shares of common stock
underlying the warrant by 4,762, reduced the qualified offering from $10 million to $7.2 million and each principal payment is
increased from 1/7 of the outstanding note principal balance to 1/6 of the outstanding note principal balance.
Additionally, on October 14, 2022, the parties
to this convertible note agreed to an amendment of this note and accompanying transaction documents. As a result of the amendment, the
first principal repayment was amended to be due on November 2, 2022, instead of October 2, 2022. We additionally amended the warrant
to increase the number of shares of common stock underlying the warrant by another 4,762 (resulting in total shares underlying the
warrant of 66,666), and each principal payment is increased from 1/6 of the outstanding note principal balance to 1/5 of the outstanding
note principal balance.
Additionally,
on November 16, 2022, the parties to this convertible note agreed to an amendment of the Note. As a result of the amendment, the first
principal repayment was amended to be due on December 17, 2022, instead of November 17, 2022. The Company also amended the warrant to
increase the number of shares of common stock underlying the warrant by another 4,762 (resulting in total shares underlying the warrant
of 71,428), and each principal payment is increased from 1/5 of the outstanding note principal balance to 1/4 of the outstanding note
principal balance.
On December 16, 2022, the parties to this convertible
note agreed to another amendment, which further delayed the first principal payment until January 17, 2023. The Company also amended
the warrant to increase the number of shares of common stock underlying the warrant by another 4,762 (resulting in total shares underlying
the warrant of 76,190) and each principal payment is increased from 1/4 of the outstanding note principal balance to 1/3 of the
outstanding principal amount.
On January 11, 2023, the parties to this convertible
note agreed to another amendment, which further delayed the first principal payment until January 31, 2023. The Company also amended
the Note to increase each principal payment from 1/3 of the outstanding note principal balance to 1/2 of the outstanding principal
amount. In connection with the amendment the Company agreed to pay the lender $5,000 of the unpaid interest due on the Note.
The common stock purchase warrant issued
in our March 2022 secured note offering may be adjusted in the number of shares underlying the warrant upon completion of this offering,
which would result in further dilution to our shareholders.
As of January 10, 2023, the lender in our
March 2022 offering owns a warrant to purchase 76,190 shares of our Common Stock. The warrant is subject to adjustment in the number
of shares underlying the warrant in the event that (i) a qualified offering occurs, which is defined, subject to an amendment to the
March 2022 transaction documents, as an offering of $7.2 million or greater of equity or debt securities, and (ii) such qualified offering
occurs at a price per share that when multiplied by 75%, is less than $0.05 per share (or $20.00 based on the reverse split of 1-for-400
as set forth on the cover page of this Prospectus). Accordingly, assuming the completion of the offering of $8,000,000 at an assumed
offering price of $6.00 per Unit (as adjusted for the reverse stock split of 1-for-400 as set forth on the cover page of this Prospectus),
then such number of shares of common stock underlying the lender’s warrant will increase to an aggregate of approximately 338,622
shares or a multiplier of approximately 4.44 times the number of shares underlying the warrant prior to the offering contemplated
by this Prospectus. Notwithstanding, the reverse stock split, as described on the cover page of this Prospectus, reduces the number of
shares underlying such warrant proportionately. In the event such warrant adjusts as described herein, our shareholders would experience
substantial dilution upon the exercise of the warrant, which has an exercise price of $0.0001, and which the aggregate exercise price
(assumed on an exercise for cash), will be substantially less than the price per Unit to be paid for by investors in the offering contemplated
by this Prospectus. Further, the exercise price of the warrant, equal to $0.0001 per share, does not proportionately increase in the
event of a reverse stock split.
Our financing documents related to the secured
convertible promissory note offering contain covenants that could restrict our ability to implement our business plan.
Pursuant to the terms of the offering documents with
the holder of our secured convertible promissory note, we must first obtain the consent of such lender before entering into certain transactions
or undertaking certain activities including, without limitation, entering into certain types of indebtedness, incurring certain types
of liens on our assets, amending our articles of incorporation in a manner that adversely affects the lender’s rights, repurchasing
shares of our Common Stock, repaying certain types of indebtedness, paying dividends or distributions on our securities, or entering
into certain transactions with any of our affiliates. While any amount is due under the secured promissory note, we will be subject to
these restrictions, unless the lender, in its sole discretion, approves such matters.
The Warrants in this offering contain
price protection for a period of 2 years from the date of issuance, which may result in the reduction of the exercise price of the
Warrants and cause future dilution to our shareholders.
The Warrants will contain certain adjustments
to the exercise price for the first 2 years of issuance, based on the then current market price in effect. As a result, the Warrants
may have their exercise prices reduced for no additional consideration. Such provisions may impair our ability to raise additional
capital on terms acceptable to us or result in greater dilution to our shareholders, each of which may materially impact our
shareholders’ ownership of our securities.
Risks
Associated with Our Contemplated Reverse Stock Split and NYSE American Listing
Even
if the reverse stock split achieves the requisite increase in the market price of our Common Stock, we cannot assure you that we will
be able to continue to comply with the minimum trading price requirement of NYSE American.
Even
if the reverse stock split achieves the requisite increase in the market price of our Common Stock to be in compliance with the minimum
bid price requirement of NYSE American, there can be no assurance that the market price of our Common Stock following the reverse stock
split will remain at a price per share sufficient to meet the continued listing standards on the NYSE American, which such price is determined
at the discretion of the NYSE American, but which has historically been a trading price of below $0.20 per share price average over a
thirty trading day period. Maintaining a low price per share for a substantial period, will result in a notice from the NYSE American
requiring the Company to complete a reverse split or be subject to delisting if not completed in a reasonable time. It is not uncommon
for the market price of a company’s Common Stock to decline in the period following a reverse stock split. If the market price
of our Common Stock declines following the effectuation of the reverse stock split, the percentage decline may be greater than would
occur in the absence of a reverse stock split. In any event, other factors unrelated to the number of shares of our Common Stock outstanding,
such as negative financial or operational results, could adversely affect the market price of our Common Stock and jeopardize our ability
to meet or maintain the NYSE American’s minimum trading price requirement.
Even
if the reverse stock split increases the market price of our Common Stock, there can be no assurance that we will be able to comply with
other continued listing standards of the NYSE American.
Even
if the market price of our Common Stock increases sufficiently so that we comply with the minimum bid price requirement, we cannot assure
you that we will be able to comply with the other standards, including the corporate governance requirements that we must satisfy in
order to maintain a listing of our Common Stock and/or Warrants on the NYSE American. Our failure to meet these requirements may
result in our Common Stock and/or Warrants sold in this offering being delisted from the NYSE American, irrespective of our compliance
with the minimum bid price requirement.
The
reverse stock split may decrease the liquidity of the shares of our Common Stock.
Once
the reverse stock split is effected, the
liquidity of the shares of our Common Stock may be affected adversely by the contemplated reverse stock split given the reduced
number of shares that will be outstanding following the reverse stock split, especially if the market price of our Common Stock does
not increase correspondingly as a result of the reverse stock split. In addition, the reverse stock split may increase the number of
stockholders who own odd lots (i.e., fewer than 100 shares) of our common stock, creating the potential for such stockholders to
experience an increase in the cost of selling their shares and greater difficulty effecting such sales.
Following
the reverse stock split, the resulting market price of our Common Stock may not attract new investors, including institutional investors,
and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our Common Stock may not improve.
Although
we believe that a higher market price of our Common Stock may help generate greater or broader investor interest, there can be no assurance
that the reverse stock split will result in a share price that will attract new investors, including institutional investors. In addition,
there can be no assurance that the market price of our Common Stock will satisfy the investing requirements of those investors. As a
result, the trading liquidity of our Common Stock may not necessarily improve.
Assuming
the conversion of our Series C Preferred Stock, the holders of our Series B Preferred Stock will still have certain rights, preferences,
and privileges over our shares of Common Stock, including the right to approve certain transactions.
As
of the date hereof, there are 227,000 shares of Series B Preferred Stock outstanding. The Series B Preferred Stock is convertible,
at the option of the holder into shares of Common Stock at $3.00 per share, or a total of 75,666 shares. The Series B Preferred
stock also has the right to receive $400.00 per share upon a liquidation, dissolution or winding up in preference to the holders of Common
Stock. The Series B Preferred Stock votes on an as converted to Common Stock basis, except that the vote of a majority of the Series
B Preferred Stock is required for (i) any amendment to the Articles of Incorporation resulting in an adverse effect to the voting powers,
preferences, or special rights of the Series B Preferred Stock (ii) the creation and issuance of securities senior to the rights, preferences,
and privileges of the Series B Preferred Stock with respect to the payment of dividends or the distribution of assets on liquidation,
dissolution or winding up, or (iii) extraordinary corporate events, including mergers, except where the Series B Preferred Stock remains
outstanding post-merger with its same rights, preferences, and privileges, or the Series B Preferred stock is converted into preferred
securities of the surviving entity in the merger not having less favorable rights, preferences, privileges and voting power. As a result
of the foregoing, we may not be able (i) to enter into certain transactions or (ii) create a senior class of preferred stock, each without
the approval of the Series B Preferred Stock holders.
Notwithstanding,
the Series B Preferred Stock automatically converts on certain fundamental transactions as described in the Articles of Incorporation,
and we have the right, at any time, to redeem some or all of the issued and outstanding shares of Series B Preferred Stock at the greater
of (i) 125% of the purchase price paid for such shares or an aggregate of approximately $283,750, or (ii) the book value for such
shares as determined by an independent auditing firm.
In
order to have our securities continue to listed on the NYSE American, among other requirements, we will need to add independent
qualified persons to our Board.
One
of the requirements for a NYSE American listing is that at least 50% of our Board be independent. Notwithstanding, the NYSE American
authorizes a “phase-in” period whereby we will be required to have, within one (1) year of listing, 50% of our Board
members be independent. While the Company is currently undertaking a search for qualified Board members, there can be no assurances that
we will be able to find qualified Board members willing to serve on our Board. Currently, we have a five (5) member Board and
only two Board members qualify as independent under NYSE American rules. In the event we are unable to attract a sufficient number of
independent qualified persons to serve on our Board, we may be unable maintain our Common Stock or Warrant listing on the NYSE American even if we are initially listed subject to
the foregoing “phase-in” period. In the event that our Common Stock or Warrant is not initially listed on the NYSE
American, we would not proceed with the offering described in this Prospectus.
In
connection with the reverse stock split, we will have additional authorized shares of Common Stock available for issuance; the issuance
of such additional shares would dilute the percentage ownership of existing stockholders.
On
October 8, 2021, our shareholders voted via written consent to authorize the Board of Directors to effect a reverse stock split at
its discretion at any time before April 8, 2023 at a ratio of not less than 1-for-2 and not more than 1-for-10,000. On September
26, 2022, we filed an amendment to our amended and restated articles of incorporation with the Secretary of State to effect a
reverse stock split at a ratio of 1-for-400. While the amendment was approved by the Secretary of State, our Common Stock has not
yet begun trading on a reverse stock split basis. The reverse split will be effected following the effectiveness of the registration
statement of which this prospectus forms a part and prior to the completion of the offering contemplated by this prospectus. Such reverse stock split
does not reduce the number of authorized shares of Common Stock, and accordingly, we have, in effect, have additional shares of
Common Stock available for issuance. Any such issuance of shares would result in a dilution of the percentage ownership of existing
stockholders.
Risks
Related to our Corporate Structure
Our
management team and Board of Directors have unilateral control over key decision making as a result of their control of a majority of
our voting stock.
As a result of
their ownership of approximately 52.3% of the voting power of our capital stock as of January 9, 2023, Richard Garr (our CEO and
CFO), Paul Michaels (our President and Director) and Dr. Barry Ginsberg (our Chief Strategy Officer and Director), were historically
able to exercise voting control of our capital stock (including capital stock owned by entities in which Controlling Shareholders control)
(collectively, (the “Controlling Shareholders”). In addition to owning common stock, the Controlling Shareholders own 18,000,000
out of 30,000,000 of our issued and outstanding shares of Series C Preferred Stock, with each such share having the right to approximately
81.66 votes as of January 9, 2023. As a result, the Controlling Shareholders, as of January 9, 2023, had the ability to
control the outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation,
or sale of all or substantially all of our assets (except where our Series B Preferred stock has certain protective provisions requiring
such series to vote as a single class for approval of certain fundamental transactions). This concentrated control could delay, defer,
or prevent a change of control, merger, consolidation, or sale of all or substantially all of our assets that our other stockholders
support, or conversely this concentrated control could result in the consummation of such a transaction that our other stockholders do
not support. This concentrated control could also discourage a potential investor from acquiring our Common Stock due to the limited
voting power of such stock relative to the voting power of our Series C Preferred Stock held by the Controlling Shareholders, and might
harm the market price of our Common Stock. Notwithstanding, all of the holders of Series C Preferred Stock have agreed to convert all
of such Series C Preferred Stock into Common Stock of the Company prior to the offering. In addition, the Controlling Shareholders have
historically had the ability to control the management and major strategic investments of our company as a result of their positions
as officers and directors and their ability to control the election or replacement of our directors. In the event of the death of the
Controlling Shareholders, the shares of our capital stock that they own will be transferred to the persons or entities that they designate
and whom may not be familiar with our business or personnel. As members of the Board and officers, the Controlling Shareholders owe a
fiduciary duty to our stockholders and must act in good faith in a manner they reasonably believe to be in the best interests of our
stockholders. As stockholders, even as controlling stockholders, the Controlling Shareholders are entitled to vote their shares, and
shares over which they have voting control, in their own interests, which may not always be in the interests of our stockholders generally.
Notwithstanding the foregoing, assuming the completion of the conversion of the outstanding Series C Preferred Stock and the completion
of the offering pursuant to this prospectus, the Controlling Shareholders ownership percentage will be reduced under 50% of the voting
power of our capital stock. Notwithstanding, the Controlling Shareholders will still hold a significant ownership interest in the Company
and will be able to vote a large percentage of our capital stock, albeit less than a controlling interest.
General Risk
Factors
Our
future success depends on our ability to attract, retain, and motivate qualified personnel.
Our
future success largely depends upon our continuing ability to attract and retain highly qualified personnel as our business grows. There
can be no assurance that we will be able to attract or retain highly qualified personnel. We face significant competition for skilled
personnel in our industry. This competition may make it more difficult and expensive to attract, hire, and retain qualified managers
and employees. Because of these factors, we may not be able to effectively manage or grow our business, which could adversely affect
our financial condition or business. As a result, the value of your investment could be significantly reduced or completely lost.
There
is no assurance that an active trading market for our Common Stock will be sustained; there is no market for our warrants and there
is no assurance that an active trading market for our warrants will develop.
While
our Common Stock listing application has been approved, we
have applied for the listing of our Warrants being offered pursuant to this prospectus on the NYSE American. However, no assurance can
be given that such application will be approved, or, if approved, that an active market for our Common Stock will be sustained or
that any active market for our Warrants will develop, or if developed, will be sustained. In addition, although there have been market
makers in our Common Stock, we cannot assure that these market makers will continue to make a market in our securities or that other
factors outside of our control will not cause them to stop market making in our securities. Making a market in securities involves maintaining
bid and ask quotations and being able to effect transactions in reasonable quantities at those quoted prices, subject to various securities
laws and other regulatory requirements. Furthermore, the development and maintenance of a public trading market depends upon the existence
of willing buyers and sellers, the presence of which is not within our control or that of any market maker. Market makers are not required
to maintain a continuous two-sided market, are required to honor firm quotations for only a limited number of securities, and are free
to withdraw firm quotations at any time. Even with a market maker, factors such as our past losses from operations and the small size
of our company mean that there can be no assurance of an active and liquid market for our securities developing in the foreseeable future.
Even if there is a market for our securities, we cannot assure that security holders will be able to resell their securities at any price.
We
have incurred, and will continue to incur, increased costs as a result of being an SEC reporting company.
The
Sarbanes-Oxley Act of 2002, as well as a variety of related rules implemented by the SEC, have required changes in corporate governance
practices and generally increased the disclosure requirements of public companies. As a reporting company, we will incur significant
legal, accounting and other expenses in connection with our public disclosure and other obligations, particularly when we no longer qualify
as an “emerging growth company”. Based upon SEC regulations currently in effect, we are required to establish, evaluate and
report on our internal control over financial reporting. We believe that compliance with the myriad of rules and regulations applicable
to reporting companies and related compliance issues will continue to require a significant amount of time and attention from our management.
If,
following this offering, our Common Stock becomes classified again as a “penny stock,” the restrictions of the penny stock
regulations of the Securities and Exchange Commission, or SEC, may result in less liquidity for our Common Stock.
The
SEC has adopted regulations which define a “penny stock” to be any equity security that has a market price (as therein defined)
of less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. Unless exempt, the rules
require the delivery, prior to any transaction involving a penny stock by a retail customer, of a disclosure schedule prepared by the
SEC relating to the penny stock market. Disclosure is also required to be made about commissions payable to both the broker/dealer and
the registered representative and current quotations for the securities. Finally, monthly statements are required to be sent disclosing
recent price information for the penny stock held in the account and information on the limited market in penny stocks. If, following
this offering, the market price for shares of our Common Stock falls below $5.00, and we do not satisfy any of the exceptions to the
SEC’s definition of penny stock, our Common Stock will be classified as a penny stock. If such should occur, as a result of the
penny stock restrictions, brokers or potential investors may be reluctant to trade in our securities, which may result in less liquidity
for our securities.
We
may invest or spend the proceeds from this offering in ways with which you may not agree.
We
intend to use the net proceeds of this offering for the following purposes: (i) the repayment of our outstanding secured convertible
promissory note issued in March 2022, (ii) the undertaking of clinical trials with respect to, our product candidates, as well as
(iii) pre-clinical research and development including manufacturing of the clinical products and (iv) general corporate
and working capital purposes. However, we will retain broad discretion over the use of the proceeds from this offering and may use them
for purposes other than those contemplated at the time of this offering. You may not agree with the ways we decide to use these proceeds.
See “Use of Proceeds.”
We
are an “emerging growth company” and are able to avail ourselves of reduced disclosure requirements applicable to emerging
growth companies, which could make our common stock less attractive to investors.
We
are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”),
and we have elected to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies
that are not “emerging growth companies” including not being required to comply with the auditor attestation requirements
of Section 404(b) of the Sarbanes-Oxley Act, 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 shareholder
approval of any golden parachute payments not previously approved. In addition, pursuant to Section 107 of the JOBS Act, as an “emerging
growth company” we have elected to take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities
Act, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption
of certain accounting standards until those standards would otherwise apply to private companies. As such, our financial statements may
not be comparable to companies that comply with public company effective dates.
We
cannot predict if investors will find our Common Stock less attractive because we may 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 may take advantage of these reporting exemptions until we are no longer an “emerging growth company.”
We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the
completion of this offering; (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.
Our
amended and restated Bylaws provide that the state of Florida is the sole and exclusive forum for substantially all disputes between
us and our stockholders, which 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 Bylaws, provide that, unless we consent to an alternative forum, courts in the State of Florida will be the sole
and exclusive forum for: (i) any derivative action or proceeding brought by or on behalf of the Company; (ii) any action asserting a
claim of breach of a fiduciary duty owed by any director, officer, or other employee of the Company to the Company or the Company’s
stockholders; (iii) any action asserting a claim arising pursuant to any provision of the FBCA or the Company’s Articles of Incorporation
or Bylaws (as either may be amended from time to time); or (iv) any action asserting a claim governed by the internal affairs doctrine.
This exclusive forum provision may limit a stockholder’s ability to choose its preferred judicial forum for disputes with us or
our directors, officers, and employees, which may discourage the filing of lawsuits with respect to such claims. There is uncertainty
as to whether a court would enforce such provision and that investors cannot waive compliance with federal securities laws and the rules
and regulations thereunder. If a court were to find this exclusive forum provision to be inapplicable or unenforceable in an action,
we may incur additional costs associated with resolving such action in another jurisdiction, which could adversely affect our business
and financial condition.
We
have identified a material weakness in our internal control over financial reporting, and the failure to remediate this material weakness
may adversely affect our business, investor confidence in our company, our financial results and the market value of our common stock.
A
material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is
a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected
on a timely basis. The material weakness we identified is our lack of maintaining a sufficient complement of personnel commensurate with
the accounting and financial reporting requirements in order to have adequate segregation of key duties and responsibilities, which affected
the operation of controls over the recording of journal entries and the reconciliation of key accounts. This material weakness did not
result in a material misstatement to the financial statements. We have begun exploring remedial efforts to address the underlying causes
of the material weakness. There can be no assurance that any remedial efforts we take, if any, will be sufficient to remediate the control
deficiencies that led to our material weakness in our internal controls over financial reporting or prevent future material weaknesses
or control deficiencies from occurring.
We
are not currently required to comply with Section 404 of the Sarbanes-Oxley Act and, therefore, are not required to make a
formal assessment of the effectiveness of our internal control over financial reporting for that purpose. Upon completion of this
offering, we will be required to comply with the requirements of Sections 302 and 404 of the Sarbanes-Oxley Act, which will
require our management to certify financial and other information in our annual reports and provide an annual management report on
the effectiveness of control over financial reporting. Though we will be required to disclose material changes in internal control
over financial reporting on an annual basis, we will not be required to make our first annual assessment of our internal control
over financial reporting pursuant to Section 404 until the year following our first filing of an annual report on Form 10-K.
Additionally, while we remain an emerging growth company, we will not be required to include an attestation report on internal
control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with
Section 404 within the prescribed period, we will be engaged in a process to document and evaluate our internal
control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate
internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of
internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that
controls are functioning as documented and implement a continuous reporting and improvement process for internal control over
financial reporting.
USE
OF PROCEEDS
We estimate that the net proceeds from this offering,
after deducting underwriting discounts and offering expenses payable by us, will be approximately $6.8 million. If the underwriter’s
over-allotment option is exercised in full, we estimate that our net proceeds will be approximately $7.8 million.
We intend to use the net proceeds of this offering
(including any over-allotment) as follows:
For required interest and redemption payments of
the secured promissory note we issued in March of 2022 to Puritan Partners, LLC an institutional investor. The secured convertible
promissory note bears interest at a rate of 12.5% per annum and has a maturity date of March 2, 2023. We anticipate that full repayment
of the secured note will be approximately $1,515,000 based on a straight-line amortization with interest and redemption payments until
the maturity date. The proceeds that we received from the secured convertible promissory were used for working capital purposes.
Additionally,
we also plan to use the proceeds to repay the outstanding promissory note issued in May 2022, which we anticipate full repayment of the
note will be approximately $208,284 with interest due and payable assuming the note is paid off on September 30, 2022. The proceeds that
we received from the promissory note were used for working capital purposes.
For
each of our programs described below, we anticipate such costs to be over the two (2) year period immediately following the receipt of
proceeds in the offering. Notwithstanding, there can be no assurances that such estimated capital needs are accurate or that we are able
to meet our budgetary estimates.
With
regard to the below estimates, we intend to use the funds to further research, develop and begin manufacturing our development stage
therapeutics. As described below, we will begin preparation for toxicology studies, animal studies, and other preliminary work
to prepare for regulatory submissions with the goal of filing one or more INDs.
Rabies
We
estimate that it will cost approximately $6.1 million to get through a combined phase I / II clinical trial. Of this amount,
we will first need to spend approximately $2.3 million in costs related to pre-clinical trials, IND-enabling studies, manufacturing,
and other costs related to submitting IND applications. Provided we are able to receive IND approval, we estimate that it will cost approximately
an additional $3.8 million to conduct and complete a combined phase I / II clinical trial.
Glioblastoma
We
estimate that it will cost approximately $4.4 million in pre-clinical, IND-enabling studies, manufacturing, and other costs related
to submitting an IND application
Retinal
Degeneration
We
estimate that it will cost approximately $2.0 million in pre-clinical, IND-enabling studies, manufacturing, and other costs related to
submitting an IND application. Provided we are able
to receive IND approval, we estimate that it will cost approximately an additional $1.0 million to conduct and complete
a phase 1 clinical trial of dry age-related macular degeneration (AMD) and Geographic Atrophy. Pursuant to the CRADA (see section of this Prospectus entitled “Product
Development” – Degenerative Eye Diseases” for more information), our contribution to the first clinical trial will be
a maximum of $115,000, with the balance to be covered by the National Eye Institute.
COVID-19
We
estimate that it will cost approximately $18 million in pre-clinical, IND-enabling studies, manufacturing, and other costs related
to submitting an IND application.
General
and Administrative
We
estimate that we will spend approximately $200,000 per month on general and administrative expenses based on the level of operations
that we estimate that the Company will need to undertake our business plan. We additionally anticipate spending at least $200,000 on
the filing and review of patent applications for our programs and indications.
The
amounts and timing of our actual expenditures will depend upon numerous factors, including the status of our research and development
efforts. We, therefore, cannot predict the relative allocation of net proceeds that we receive in this offering and may allocate it differently
than indicated above. As a result, management will have broad discretion over the use of the net proceeds from this offering.
In
the event we are not able to raise sufficient capital in this offering, or if the costs associated with our development projects exceeds
our estimates, we will require raising additional capital to pursue our pre-clinical and clinical development plans and to continue to
fund our operations. We anticipate raising additional cash through the private and public sales of equity or debt securities, collaborative
arrangements, licensing agreements or a combination thereof. Although management believes that such funding sources will be available,
there can be no assurance that any such collaborative arrangement will be entered into or that financing will be available to us when
needed in order to allow us to continue our operations, or if available, on terms acceptable to us. If we do not raise sufficient funds
in a timely manner, we may be forced to curtail operations, delay or stop our ongoing clinical trials, cease operations altogether, or
file for bankruptcy. We currently do not have commitments for future funding from any source. We cannot assure you that we will be able
to secure additional capital or that the expected income will materialize. Several factors will affect our ability to raise additional
funding, including, but not limited to market conditions, interest rates and, more specifically, our progress in our exploratory, preclinical
and future clinical development programs.
CAPITALIZATION
The following table sets forth our consolidated capitalization
as of September 30, 2022 (i) on an actual basis, (ii) on a pro forma basis assuming the conversion of all Series C Preferred Stock
to Common Stock and (iii) on a pro forma as adjusted basis to give effect to both the conversion of all Series C Preferred stock to Common
Stock and the offering at the assumed public offering price of $6.00 per Unit, based on a pro forma reverse stock split ratio of 1-for-400,
for total net proceeds of approximately $6.8 million (assuming no exercise of the underwriter’s over-allotment option).
This
information should be read together with our consolidated financial statements and other financial information set forth in our financial
statements and related notes included elsewhere in this prospectus.
| |
|
At
September 30, 2022 |
|
|
|
|
| |
|
Actual |
|
|
Pro
Forma |
|
|
Pro
Forma, as Adjusted |
|
| |
|
|
|
|
|
|
|
|
|
| Cash |
|
$ |
636 |
|
|
$ |
636 |
|
|
$ |
6,825,634 |
|
| Warrant
Liability |
|
|
- |
|
|
|
- |
|
|
|
606,533 |
|
| Preferred
stock, Series C, $.0001 par value; 30,000,000 shares authorized, issued and outstanding on an actual basis and no shares issued and
outstanding on a pro forma and proforma as adjusted basis |
|
|
18,065,735 |
|
|
|
- |
|
|
|
- |
|
| Stockholders’
(Deficit) Equity |
|
|
|
|
|
|
|
|
|
|
|
|
| Preferred
stock, Series B, $.0001 par value; 1,000,000 shares authorized, 81,000 shares issued and outstanding on an actual, pro forma and
pro forma as adjusted basis |
|
|
8 |
|
|
|
8 |
|
|
|
8 |
|
| Common
stock, $.0001 par value; 1,100,000,000 shares authorized; 1,429,129 shares issued and outstanding on an actual basis; 2,041,612 issued
and outstanding on a pro forma basis and 3,374,945 shares issued and outstanding on pro forma as adjusted basis, respectively |
|
|
143 |
|
|
|
204 |
|
|
|
337 |
|
| Additional
paid-in capital |
|
|
11,922,430 |
|
|
|
29,988,104 |
|
|
|
36,206,436 |
|
| Accumulated
deficit |
|
|
(31,041,348 |
) |
|
|
(31,041,348 |
) |
|
|
(31,041,348 |
) |
| Total
stockholders’ (deficit) equity |
|
|
(19,118,767 |
) |
|
|
(1,053,032 |
) |
|
|
5,165,433 |
|
| Total
capitalization |
|
$ |
(1,053,032) |
|
|
$ |
(1,053,032 |
) |
|
$ |
5,771,966 |
|
The
discussion and table above assume no exercise of the Underwriter’s warrants which we will issue to the Underwriter upon completion
of this offering. See “Underwriting—Underwriter Warrants” for details of the Underwriter’s warrants.
DILUTION
If you invest in the Units offered by
this prospectus, you will suffer immediate and substantial dilution in the net tangible book value per share of Common Stock.
As of September 30, 2022, we had a deficiency
in net tangible book value of $(21,096,505), or ($14.76) per share. The net tangible book value (deficit) per share of
Common Stock is determined by subtracting total liabilities from the total book value of the tangible assets and dividing the difference
by the number of shares of post reverse split Common Stock deemed to be outstanding as of September 30, 2022. After giving effect
to the conversion of Series C Preferred Stock to Common Stock, our pro forma deficiency in net tangible book value would have been $(3,030,770)
or $(1.48) per share. After giving effect to the sale of 1,333,333 Units offered by us in this offering at an assumed offering
price of $6.00 per Unit based on a pro forma reverse stock split ratio of 1-for-400, and the application of the estimated net proceeds
from this offering, our as adjusted net tangible book value as of September 30, 2022 would have be $3,187,695 or $0.94
per share. This represents an immediate increase in net tangible book value to existing stockholders of $2.42 per share and
an immediate dilution to new investors of $5.06 per share. The following table illustrates this per share dilution to new investors
purchasing shares in this offering.
| Assumed
offering price per share |
|
|
|
|
|
$ |
6.00 |
|
| Deficiency
in net tangible book value per share as of September 30, 2022 |
|
$ |
(13.86 |
) |
|
|
|
|
| Increase
per share attributable to the conversion of preferred stock |
|
$ |
13.28 |
|
|
|
|
|
| Pro
forma deficiency in net tangible book value per share as of September 30, 2022, before giving effect to this offering |
|
$ |
(1.48 |
) |
|
|
|
|
| Increase
attributable to new investors in this offering |
|
$ |
2.42 |
|
|
|
|
|
| As
adjusted, net tangible book value per share after the offering |
|
|
|
|
|
$ |
0.94 |
|
| Dilution
per share to new investors |
|
|
|
|
|
$ |
5.06 |
|
If the underwriter exercises in full their over-allotment
option to purchase additional Units in this offering, the pro forma net tangible book value per share after the offering would be $1.18
per share, the increase in net tangible book value per share to existing stockholders would be $0.24 per share and the dilution
to new investors purchasing Units in this offering would be $4.82 per share.
The following table sets forth, on an unaudited as
adjusted basis, as of September 30, 2022, the difference between the total consideration paid and the average price per share
of Common Stock paid by existing stockholders and by the new investors purchasing share in this offering at an assumed offering price
of $6.00 per share, based on a pro forma reverse stock split ratio of 1-for-400, before deducting underwriting discounts and estimated
offering expenses payable by us:
| |
|
Shares Purchased* |
|
|
Total Consideration |
|
|
Average
Price Per |
|
| |
|
Number |
|
|
Percent |
|
|
Amount |
|
|
Percent |
|
|
Share |
|
| |
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
|
|
| Existing stockholders |
|
|
2,041,612 |
|
|
|
60.5 |
% |
|
$ |
30,163,102 |
|
|
|
79.0 |
% |
|
$ |
14.77 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| New investors |
|
|
1,333,333 |
|
|
|
39.5 |
% |
|
$ |
7,999,998 |
|
|
|
21.0 |
% |
|
$ |
6.00 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Totals |
|
|
3,374,945 |
|
|
|
100.0 |
% |
|
|
38,163,100 |
|
|
$ |
100.0 |
% |
|
$ |
11.31 |
|
*
Presented on a pro forma basis, reflecting a 1-for-400 reverse stock split of our Common Stock which will become effective for
trading purposes after this Registration Statement is declared effective by the SEC and simultaneously with the closing of
this offering
The above discussion and table
are based on 2,041,612 shares of Common Stock outstanding as of September 30, 2022, after giving effect to the conversion of the
Series C Preferred Stock, but excludes (based on the 1-for-400 reverse stock split ratio as described on the cover page of this prospectus):
| |
● |
176,246 shares of our common stock issuable upon the exercise of Warrants.
Notwithstanding, such amount of warrants will increase by 262,432 shares of Common Stock (assuming the $5.80 offering price
and 1-for-400 reverse stock split as set forth on the cover page of this Prospectus) underlying the warrant issued to the lender
in our March 2022 convertible note offering pursuant to an adjustment feature in the number of shares underlying the warrant upon
the consummation of an offering at least $7.2 million at a price per share in such offering that if multiplied by 75%, would be less
than $20.00; |
| |
|
|
| |
● |
18,641 shares of our common stock issuable upon exercise of options
to purchase shares of our common stock outstanding as of September 30, 2022, under our Stock Option Plan, with a weighted-average
exercise price of $20.70 per share; |
| |
|
|
| |
● |
121,521 shares of our common stock reserved for future issuance under
our Stock Option Plan; and |
| |
|
|
| |
● |
The exercise of Warrants contained in the Units. |
To
the extent that outstanding options and warrants are exercised, investors will experience further dilution. In addition, we may choose
to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our
current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities,
the issuance of these securities may result in further dilution to our stockholders.
The discussion and tables above assume no exercise
of the Underwriter’s warrants which we will issue to the Underwriter upon completion of this offering. See “Underwriting—Underwriter
Warrants” for details of the Underwriter’s warrants. To the extent that any of these Underwriter’s warrants are exercised,
there will be further dilution to new investors.
DETERMINATION
OF OFFERING PRICE
The
offering price for the Units offered by this prospectus and the exercise price for the warrants forming of a portion of the Units have
been negotiated between the underwriter and us. In determining such offering price and exercise price, the following factors were considered:
| |
● |
prevailing
market conditions; |
| |
|
|
| |
● |
our
historical performance and capital structure; |
| |
|
|
| |
● |
estimates
of our business potential and earnings prospects; |
| |
|
|
| |
● |
an
overall assessment of our management; and |
| |
|
|
| |
● |
the
consideration of these factors in relation to the market valuation of companies in related businesses. |
Transactions
in our Common Stock are currently reported under the symbol “CUBT” on the OTC Pink. Any over-the-counter market quotations
reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may not necessarily represent actual transactions.
As of January 9, 2023, there were 215 record
holders of our shares of Common Stock.
DIVIDEND
POLICY
Holders
of our shares of Common Stock are entitled to dividends when, as and if declared by our Board of Directors out of legally available funds.
We
have not declared or paid any dividends in the past to the holders of our Common Stock and do not currently anticipate declaring or paying
any dividends in the foreseeable future. We intend to retain earnings, if any, to finance the development and expansion of our business.
Future dividend policy will be subject to the discretion of our Board of Directors and will be contingent upon future earnings, if any,
our financial condition, capital requirements, general business conditions, and other factors. Therefore, we can give no assurance that
any dividends of any kind will ever be paid to holders of our Common Stock.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements
regarding our business development plans, pre-clinical and clinical studies, regulatory reviews, timing, strategies, expectations, anticipated
expenses levels, business prospects and positioning with respect to market, demographic and pricing trends, business outlook, technology
spending and various other matters (including contingent liabilities and obligations and changes in accounting policies, standards and
interpretations) and express our current intentions, beliefs, expectations, strategies or predictions. These forward-looking statements
are based on a number of assumptions and currently available information and are subject to a number of risks and uncertainties. Our
actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including
those set forth under “Special Note Regarding Forward-Looking Statements” and under “Risk Factors” and elsewhere
in this Prospectus. The following discussion should be read in conjunction with our financial statements and related notes thereto
included elsewhere in this Prospectus.
Our
Management’s Discussion and Analysis of Financial Condition and Results of Operations, (MD&A), is provided in addition
to the accompanying audited annual and unaudited financial statements and notes to assist readers in understanding our results
of operations, financial condition and cash flows. Our MD&A is organized as follows:
| |
● |
Executive
Overview — Overview discussion of our business in order to provide context for
the remainder of MD&A. |
| |
● |
Critical
Accounting Policies— Accounting policies that we believe are important to understanding
the assumptions and judgments incorporated in our reported financial results and forecasts. |
| |
● |
Results
of Operations— Analysis of our financial results comparing the: (i) year ended December
31, 2021 to the year ended December 31, 2020, and (ii) three and nine months ended
September 30, 2022 to the three and nine months ended September 30,
2021 |
| |
● |
Liquidity
and Capital Resources—Analysis of cash flows and discussion of our financial condition and future liquidity needs. |
Executive
Overview
The
Company is a Florida Corporation that conducts business from its headquarters in Boca Raton, Florida. The Company was formerly known
as Connectyx Technologies Holdings Group, Inc., which was formed as a Nevada corporation on June 29, 1995, reincorporated in Florida
on October 30, 2007, with a name change in November 2020 under completely new management with a completely different business plan and
mission. The Company is a development stage biomedical company that seeks to develop, in-license, sub-license and bring to market products
in both the Pharmaceutical and Medical Device space. The Company focuses, but not exclusively on products that are targeted at FDA-defined
“Orphan Diseases” which are diseases with patient populations under 200,000 in the United States. The Company leverages management’s
experience and business relationships in the Life Science community to acquire therapeutic candidates that fit within the company’s
business model; finding programs that can be acquired at appropriate valuations; programs that have some accelerated path to commercialization;
and programs where material inflexion points can be created within a two-year window. The Company has to date in licensed 4 therapeutic
programs: The reformulation of metformin to treat degenerative eye diseases, from the National Eye Institute (NEI) at the National Institutes
of Health (NIH); CD56 monoclonal antibody drug conjugate technology from the National Cancer Institute (NCI) to treat newly diagnosed
glioblastoma; IMT504 which is a synthetic immunotherapy to treat late stage rabies as a stand-alone therapy; and IMT504 as an adjuvant
to be added to protein vaccines to provide pan variant protection from Covid viruses. The Company has worldwide exclusive rights to the
intellectual property in licensed in all four programs and can provide the following updates on these programs.
Using reformulated (into an eye drop) metformin to
treat Intermediate Dry Age-Related Macular degeneration is the company’s lead program. The Company has announced the completion
of the non GLP tolerability and toxicology testing, and the initiation of IND enabling GLP tolerability and toxicology studies. The Company
has also announced that it will be developing this therapy in collaboration with the NEI, where the first clinical trial will be conducted
after FDA approval of an IND, under the direction of Dr. Emily Chew. Dr. Chew is the Director of the Division of Epidemiology
and Clinical Applications (DECA), at the National Eye Institute, the National Institutes of Health.
The Company has begun the process manufacturing
of its Monoclonal antibody drug conjugate to treat newly diagnosed Glioblastoma and is targeting non glp animal safety and proof of principle
animal studies in Q1 2023 at Emory University conducted by Clinical and Scientific Advisory Board Member Dr. Nick Boulis.
The Company is targeting the end of this year
to submit a pre IND meeting briefing book to the FDA for its proposed clinical trial of IMT504 to treat late stage rabies.
Additionally, the Company has also announced that
(i) Cary Sucoff Esq. has joined the Board of Directors as an Independent Director and Chairman of the Audit Committee and (ii) Lawrence
Zaslow joined the Board of Directors as an Independent director and Chairman of the Compensation Committee.
It
is our plan after reaching key inflection points in each program to then partner the assets with companies that have the
appetite and resources for commercial launch. The company has established a clinical and scientific advisory board with a successful
track record of bringing pharmaceuticals to market across multiple disease areas. The Company is virtually distributed with a small group
of executives managing a worldwide consortium of outsourced vendors in order to mitigate the costs and risks of internal infrastructure.
Components
of Results
Revenue
We
have generated no revenues from the sale, licensing or other development of our proposed product candidates presented.
On
a long-term basis, we anticipate that our revenue will be derived primarily from licensing fees and/or outright sales of our therapeutic
program assets. Because we are at such an early stage in the development process, we are not yet able to accurately predict when we will
have a product ready for commercialization, if ever, and whether any product can generate sufficient revenue, if at all.
Research
and Development Expenses
We
are just beginning our research and development efforts. Our research and development expenses are expected to consist primarily of manufacturing
and pre-clinical studies, clinical trial expenses, including payments to clinical trial sites that perform our clinical trials and clinical
research organizations (CROs) that help us manage our clinical trials.
General
and Administrative Including Salaries and Professional Fees Expenses
General
and administrative, salaries and professional fees expenses are primarily composed of salaries, benefits and other costs associated with
our operations including, finance, human resources, information technology, public relations and costs associated with maintaining a
public company including listing, legal, audit and compliance fees, facilities and other external general and administrative services.
Additionally, expenses include non-cash share-based compensation expenses resulting from granting of equity awards to both employees
and consultants in return for services.
Critical
Accounting Policies and Significant Judgments and Estimates
The preparation of these
financial statements in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”)
requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses. Note
2 of the Notes to the Financial Statements included elsewhere herein describes the
significant accounting policies used in the preparation of the financial statements. Certain of these significant accounting policies
and estimates have a higher degree of inherent uncertainty and required our most significant judgments.
A
critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management
to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations.
Specifically, critical accounting estimates have the following attributes: (1) we are required to make assumptions about matters that
are highly uncertain at the time of the estimate; and (2) different estimates we could reasonably have used, or changes in the estimate
that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.
Estimates
and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience
and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new
events occur, as additional information is obtained and as our operating environment changes. These changes have historically been minor
and have been included in the financial statements as soon as they became known. Based on a critical assessment of our accounting policies
and the underlying judgments and uncertainties affecting the application of those policies, management believes that our financial statements
are fairly stated in accordance with U.S. GAAP, and present a meaningful presentation of our financial condition and results of operations.
We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation
of our consolidated financial statements:
Intangible
Assets – The useful life of intangible assets is assessed as either finite or indefinite. Following the initial
recognition, intangible assets are carried at cost less any accumulated amortization and accumulated impairment losses, if any. Intangible
assets with finite useful lives are carried at cost less accumulated amortization. Amortization is calculated using the straight-line
method over the estimated useful lives. Intangible assets with indefinite useful lives are not amortized, but are tested for impairment
annually. The assessment of indefinite life is reviewed annually to determine whether the indefinite life continues to be supportable.
If not, the change in useful life from indefinite to finite is made on a prospective basis. If impairment indicators are present, these
assets are subject to an impairment review. Any loss resulting from impairment of intangible assets is expensed in the period the impairment
is identified.
Share-Based
Compensation – Stock-based compensation is accounted for based on the
requirements of the Share-Based Payment Topic of ASC 718 which requires recognition in the
consolidated financial statements of the cost of employee and director services received
in exchange for an award of equity instruments over the shorter of period the employee or
director is required to perform the services in exchange for the award or the vesting period.
The ASC also requires measurement of the cost of employee and director services received
in exchange for an award based on the grant-date fair value of the award. Pursuant to ASC
505-50, for share-based payments to non-employees, compensation expense is determined at
the “measurement date.” The expense is recognized over the service period of
the award. Until the measurement date is reached, the total amount of compensation expense
remains uncertain. The Company initially records compensation expense based on the fair value
of the award at the reporting date.
Our
determination of the fair value of stock options with time-based vesting on the date of grant utilizes the Black-Scholes option pricing
model, and is impacted by our common stock price as well as other variables including, but not limited to, expected term that options
will remain outstanding, expected common stock price volatility over the term of the option awards, risk-free interest rates and expected
dividends. Estimating the fair value of equity-settled awards as of the grant date using valuation models, such as the Black-Scholes
option pricing model, is affected by assumptions regarding a number of complex variables. Changes in the assumptions can materially affect
the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require
significant analysis and judgment to develop.
Results
of Operations
Comparison
of Our Results of Operations for the Three Months Ended September 30, 2022 and 2021
Revenue
We
have not recognized revenue in any of the periods presented.
Operating
Expenses
Operating
expenses for three months ended September 30, 2022 and 2021 were as follows:
| |
|
Three
Months Ended
September 30, |
|
|
Increase
(Decrease) |
|
| |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| General
and administrative (G&A) expenses, salaries and share based compensation and professional fees separately stated below |
|
$ |
77,504 |
|
|
$ |
10,275 |
|
|
$ |
67,229 |
|
|
|
654.3 |
% |
| Salaries
and share based compensation – G&A |
|
|
279,206 |
|
|
|
611,839 |
|
|
|
(332,633 |
) |
|
|
(54.4 |
)% |
| Professional
fees and share based compensation – G&A |
|
|
265,542 |
|
|
|
116,253 |
|
|
|
149,289 |
|
|
|
128.4 |
% |
| Research
and development |
|
|
456,377 |
|
|
|
125,947 |
|
|
|
330,430 |
|
|
|
262.4 |
% |
| Depreciation
and amortization |
|
|
1,988 |
|
|
|
1,990 |
|
|
|
(2 |
) |
|
|
(0.1 |
)% |
| Total
operating expenses |
|
$ |
1,080,617 |
|
|
$ |
866,304 |
|
|
$ |
214,313 |
|
|
|
24.7 |
% |
General
and Administrative Expenses
General
and administrative expenses (excluding salaries, professional fees and share based compensation) for the three months ended September
30, 2022, primarily consists of office expenses and supplies.
Salaries
and share-based compensation – G&A include approximately ($20,000) and $343,000 of non-cash, share-based compensation
for the three months ended September 30, 2022, and 2021, respectively. Excluding share-based compensation, G&A salaries increased
approximately $30,000, as a result of us continuing to increase our operations as we shift our focus to the development of our
product candidates
Professional
fees and share based compensation for the three months ended September 30, 2022, and 2021, include approximately $250,000
and $19,000, respectively, of non-cash share-based compensation. Excluding this, professional fees increased approximately $82,000,
which related to the building the business as we shift our focus to the development of our product candidates.
Research
and development
Research
and development activities during the three months ended September 30, 2022 increased by 262.4% (from approximately $125,947
to $265,542). The was primarily the result of additional spending on manufacturing and testing on our metformin formulation
and creating preclinical data for our CRADA with NIH to treat Dry Age Related Macular Degeneration. Under the CRADA our primary responsibility
is to deliver the IND to the NEI and the drug for the trial. The company is dedicating almost all of its R&D spending to this program.
Interest
expense
Interest
expense was approximately $341,873 and $0 for the three months ended September 30, 2022, and 2021, respectively,
including the amortization of debt discount. The increase is due to the additional loans obtained in the first and second quarters
of 2022.
Comparison of Our Results of Operations for the
Nine Months Ended September 30, 2022 and 2021
Revenue
We have not recognized
revenue in any of the periods presented.
Operating Expenses
Operating expenses for nine months ended September
30, 2022 and 2021 were as follows:
| |
|
Nine
Months Ended
September 30, |
|
|
Increase
(Decrease) |
|
| |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| General
and administrative (G&A) expenses, salaries and share-based compensation and professional fees separately stated below |
|
$ |
170,303 |
|
|
$ |
37,271 |
|
|
$ |
133,032 |
|
|
|
356.9 |
% |
| Salaries
and share-based compensation – G&A |
|
|
1,184,719 |
|
|
|
2,964,089 |
|
|
|
(1,779,370 |
) |
|
|
(60.0 |
)% |
| Professional
fees and share based compensation – G&A |
|
|
422,574 |
|
|
|
836,194 |
|
|
|
(413,620 |
) |
|
|
(49.5 |
)% |
| Research
and development |
|
|
1,548,830 |
|
|
|
221,087 |
|
|
|
1,327,743 |
|
|
|
600.6 |
% |
| Impairment
of long-lived assets |
|
|
- |
|
|
|
15,000 |
|
|
|
(15,000 |
) |
|
|
(100.0 |
)% |
| Depreciation
and amortization |
|
|
5,967 |
|
|
|
4,755 |
|
|
|
1,212 |
|
|
|
25.5 |
% |
| Total
operating expenses |
|
$ |
3,332,393 |
|
|
$ |
4,078,396 |
|
|
$ |
(746,003 |
) |
|
|
(18.3 |
)% |
General and Administrative
Expenses
Overall general and administrative
expenses for the nine months ended September 30, 2022, primarily consists of share-based compensation, salaries, legal
fees and other consulting fees. The increase (excluding share-based compensation) over the comparable nine month period ending
September 30, 2021 is the result of us continuing to increase our operations as we shift our focus to the development of our product
candidates. We expect these expenses to continue to increase as we increase our development and operating activities and the support
for those activities also increases. We also expect increased expenses related to becoming an exchange-listed company.
General and administrative
expenses (excluding salaries, professional fees and share based compensation) for the nine months ended September 30, 2022,
primarily consists of office expenses and supplies.
Salaries and share-based
compensation – G&A primarily include approximately $223,000 and $2,260,000 of non-cash, share-based compensation
for the nine months ended September 30, 2022, and 2021, respectively. The decrease was caused by compensation expense incurred
related to the conversion of Series A preferred stock during the nine months ended September 30, 2021. Excluding share-based
compensation, G&A salaries increased approximately $258,000, as a result of us continuing to increase our operations as we
shift our focus to the development of our product candidates
Professional fees and share
based compensation for the nine months ended September 30, 2022, and 2021, include approximately $268,000 and $654,000,
respectively, of non-cash share-based compensation. Excluding this, professional fees increased by a modest $28,000.
We also intend to bring
in highly experienced and qualified advisors to help our Clinical and Scientific Advisory Board oversee the development of our therapeutic
programs.
Research and development
Research and development activities during the nine
months ended September 30, 2022 increased by over 600.6% (from approximately $221,000 to just under $1,549,000.
The was primarily the result of additional spending on manufacturing and testing on our metformin formulation and creating preclinical
data for our CRADA with NIH to treat Dry Age Related Macular Degeneration. Under the CRADA our primary responsibility is to deliver the
IND to the NEI and the drug for the trial. The company is dedicating almost all of its R&D spending to this program.
Impairment of long-lived
assets
During the nine months ended September
30, 2021, we recognized zero and $15,000 impairment charges, attributable to the write-off of certain assets that we deemed not recoverable.
No such impairment charge was taken during the nine months ended September 30, 2022.
Interest expense
Interest expense was approximately
$773,801 and $176,672 for nine months ended September 30, 2022, and 2021, respectively, including the amortization
of debt discount. The increase is due to the additional loans obtained in the first and second quarters of 2022.
Comparison of Our Results of Operations for the
Years Ended December 31, 2021 and 2020
Revenue
We
have not recognized revenue in any of the periods presented.
Operating
Expenses
Operating
expenses for 2021 and 2020 were as follows:
| | |
Year Ended December 31, | | |
Increase (Decrease) | |
| | |
2021 | | |
2020 | | |
$ | | |
% | |
| | |
| | |
| | |
| | |
| |
| General and administrative (G&A) expenses, salaries and share-based compensation
and professional fees separately stated below | |
$ | 79,523 | | |
$ | 26,689 | | |
$ | 52,834 | | |
| 198.0 | % |
| Salaries and share-based compensation – G&A | |
| 3,214,987 | | |
| 4,446,043 | | |
| (1,231,056 | ) | |
| (27.7 | )% |
| Professional fees and share-based compensation – G&A | |
| 916,845 | | |
| 125,570 | | |
| 791,275 | | |
| 630.2 | % |
| Research and development | |
| 779,275 | | |
| - | | |
| 779,275 | | |
| NM | |
| Impairment of long-lived assets | |
| 16,958 | | |
| 32,136 | | |
| (15,178 | ) | |
| (47.2 | )% |
| Depreciation and amortization | |
| 6,744 | | |
| 5,301 | | |
| 1,443 | | |
| 27.2 | % |
| Total operating expenses | |
$ | 5,014,332 | | |
$ | 4,635,739 | | |
$ | 378,593 | | |
| 8.2 | % |
NM – not meaningful
General
and Administrative Expenses
General
and administrative fees for the year ended December 31, 2021, primarily consists of share-based compensation, salaries, legal fees and
other consulting fees. The increase over the comparable period of 2020 (excluding share-based compensation) is the result of us
continuing to increase our operations as we shift our focus to the development of our product candidates. We expect these expenses to
continue to increase as we increase our development and operating activities and the support for those activities also increases. We
also expect increased expenses related to becoming an exchange-listed company.
Salaries
and share-based compensation reflect our expansion of our executive management team in the fourth quarter of 2020 as we undertake our
development and operating activities. Salaries and share-based compensation primarily include approximately $2,198,106 and $4,214,043
of non-cash, share-based compensation for the years ended December 31, 2021, and 2020, respectively. We expect the addition of a
limited number of additional employees to support the growing complexity of running three or possibly four clinical programs simultaneously,
although we anticipate continuing to manage the programs through our network of outsourced vendors.
Professional
fees and share based compensation for the year ended December 31, 2021, and 2020, primarily consist of $691,461 and $88,335, respectively,
of non-cash share-based compensation provided to services related to the building the business as we shift our focus to the development
of our product candidates. We expect this number to increase in the event we become an exchange-listed company. We would also expect
patent legal costs to increase, as we add value to our therapeutic programs through intellectual property and as we continue to prosecute
the existing patent applications that we have in-licensed.
We
also intend to bring in highly experienced and qualified advisors to help our Clinical and Scientific Advisory Board oversee the development
of our therapeutic programs.
Research
and development
We
had no research and development activities in 2020 as we were focused on acquiring licenses and setting up our business and corporate
structure. During 2021, many of our product candidates were in early-stage research or translational phases of development. As
a result, we began using outside consultants for research and development activities in 2021. We expect research and development
costs to increase significantly going forward as we continue our development efforts primarily through outsourced vendors.
Impairment
of long-lived assets
In
the years ended December 31, 2021, and 2020, we recognized impairment charges of $16,958 and $32,136, respectively, attributable
to the write-off of certain assets that we deemed not recoverable.
Other expense
Other
expense of approximately $326,022 and $34,516 for the
years ended December 31, 2021, and 2020, respectively, consisted of $176,672 and $34,500
of interest expense, including the amortization of debt discount and $149,350 of loss on debt extinguishment for the year ended December
31, 2021.
Liquidity
and Capital Resources
Since
our inception, we have financed our operations through the sales of our equity securities, issuance of debt and the exercise of stock
purchase warrants.
We had cash and cash equivalents of $636 at
September 30, 2022. In the fourth quarter of 2020 and the first quarter of 2021, we raised approximately $385,000 and $180,000,
respectively of net proceeds from the issuance of notes payable and warrants. In 2021, we received proceeds of approximately $525,000
from the exercise of outstanding stock purchase warrants and we received approximately $1,573,000 through the sale of our common stock
and stock purchase warrants. In the first quarter of 2022, we raised approximately $870,000 of net proceeds from the issuance of a senior
secured note payable. The Note carries a 12.5% interest rate with interest-only payments payable monthly from April through August 2022.
Beginning in September 2022, we were required to make monthly redemptions at the rate of 110% of one seventh of the
original principal amount ($179,592), plus interest. The Note also carries a mandatory prepayment at 125% of the original principal
amount, or $1,428,571, less any redemptions made, upon the completion of a debt or equity offering resulting in gross proceeds to us
of at least $10 million. On August 18, 2022, the note parties agreed to an extension of this note whereby beginning in October 2022,
we were required to make monthly redemptions at the rate of 110% of one sixth of the original principal amount, ($179,592), plus
interest. On October 14, 2022, the parties to this convertible note agreed to an amendment of the Note. As a result of the amendment,
the first principal repayment was amended to be due on November 2, 2022, instead of October 2, 2022. The Company also amended the warrant
to increase the number of shares of common stock underlying the warrant by another 4,761 (resulting in total shares underlying the warrant
of 66,666), and each principal payment was increased from 1/6 of the outstanding note principal balance to 1/5 of the outstanding note
principal balance. On November 2, 2022, the parties to this convertible note agreed to another amendment, which further delayed the first
principal payment until November 17, 2022. There was no change to the number of warrants as a result of this amendment.
On November 16, 2022, the parties to this convertible
note agreed to another amendment, which further delayed the first principal payment until December 17, 2022. The Company also amended
the warrant to increase the number of shares of common stock underlying the warrant by another 4,762 (resulting in total shares underlying
the warrant of 71,428) and each principal payment is increased from 1/5 of the outstanding note principal balance to 1/4 of the
outstanding principal amount.
On December 16, 2022, the parties to this convertible
note agreed to another amendment, which further delayed the first principal payment until January 17, 2023. The Company also amended
the warrant to increase the number of shares of common stock underlying the warrant by another 4,762 (resulting in total shares underlying
the warrant of 76,190) and each principal payment is increased from 1/4 of the outstanding note principal balance to 1/3 of the outstanding
principal amount.
On January 11, 2023, the parties to this convertible
note agreed to another amendment, which further delayed the first principal payment until January 31, 2023. The Company also amended
the Note to increase each principal payment from 1/3 of the outstanding note principal balance to 1/2 of the outstanding principal
amount. In connection with the amendment the Company agreed to pay the lender $5,000 of the unpaid interest due on the Note.
In December 2022, the Company sold 146,000 shares
of Series B Preferred Stock for $146,000 and issued 19,048 shares of common stock upon the exercise of warrants, which resulted in $152,390
of cash proceeds.
In May 2022 we issued a promissory note in
exchange for $200,000 in cash. This note carries a 12% interest rate, and a 6 month maturity. This note is extendible at the lender’s
option and the second six months carries an 18% interest rate.
Based on our expected operating cash requirements
we anticipate our current cash on hand will not be sufficient to fund our operations for at least 12 months after this filing. Assuming
the successful completion of the offering of $8.0 million of gross proceeds as contemplated in this Prospectus, we expect to be
able to fund our operations for approximately 18 months. Consequently, we will require additional
capital to fund our operations. Despite our ability to secure capital in the past, there can be no assurance that additional equity
or debt financing will be available to us when needed or that we may be able to secure funding from any other sources. Consequently,
as explained in Note 3 to our condensed, consolidated financial statements, management has determined that there is substantial doubt
about our ability to continue as a going concern.
We will require additional capital to pursue
our product development plans. To continue to fund our operations and the development of our product candidates we anticipate raising
additional cash through the private and public sales of equity or debt securities, collaborative arrangements and licensing agreements.
Although management believes that such funding sources will be available, there can be no assurance that any such financing will be available
to us when needed in order to allow us to continue our operations, or if available, on terms acceptable to us. If we do not raise sufficient
funds in a timely manner, we may be forced to curtail operations, delay or stop our ongoing development, cease operations altogether,
or file for bankruptcy. We cannot assure you that we will be able to secure additional capital or that any license revenue will materialize.
Several factors will affect our ability to raise additional funding, including, but not limited to market conditions, interest rates and,
more specifically, our progress in our exploratory, preclinical and future clinical development programs.
Comparisons of Nine Months Ended September
30, 2022 compared to 2021
| |
|
Nine
Months Ended
September 30, |
|
|
Increase
(Decrease) |
|
| |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Net
cash used in operating activities |
|
$ |
(1,671,386 |
) |
|
$ |
(1,024,263 |
) |
|
$ |
(647,123 |
) |
|
|
(63.2 |
)% |
| Net
cash used in investing activities |
|
$ |
(76,905 |
) |
|
$ |
(14,500 |
) |
|
$ |
(62,405 |
) |
|
|
(430.4 |
)% |
| Net
cash provided by financing activities |
|
$ |
1,078,664 |
|
|
$ |
1,610,000 |
|
|
$ |
(531,336 |
) |
|
|
(33.0 |
)% |
Net Cash Used in Operating Activities
Cash used in operating activities for the
nine months ended September 30, 2022, reflects our $4,102,134 net loss for the nine months adjusted for certain
non-cash items including: (i) 491,641 of share-based compensation, (ii) $680,255 of non-cash interest expense, and (iii)
$1,252,885 of net changes in our operating assets and liabilities.
Cash used in operating activities for the
nine months ended September 30, 2021, reflects our $4.404,418 net loss for the nine months adjusted for certain
non-cash items including: (i) $2,913,676 of share-based compensation, (ii) $174,722 of non-cash interest expense, (iii)
$15,000 write-off of abandoned assets and (iv) $122,652 of net changes in our operating assets and liabilities.
Net Cash Used in Investing
Activities
Cash used in investing activities
during the nine months ended September 30, 2022, and 2021 consisted of our acquisition of intangible assets of $76,905
and $14,500, respectively.
Net Cash Provided by
Financing Activities
For the nine months ended September
30, 2022, net cash provided by financing activities of $1,078,664 primarily consisted of proceeds received for the
issuance of notes payable.
For the nine months ended September
30, 2021, cash from financing activities of $1,610,000 primarily consisted of cash received from the issuance of common
stock and exercise of warrants.
Comparisons
of Cash Flows – Years Ended
December 31, 2021 compared to 2020
| | |
Years
Ended
December 31, | | |
Increase
(Decrease) | |
| | |
2021 | | |
2020 | | |
$ | | |
% | |
| | |
| | |
| | |
| | |
| |
| Net
cash used in operating activities | |
$ | (1,604,035 | ) | |
$ | (190,093 | ) | |
$ | (1,413,942 | ) | |
| (743.8 | )% |
| Net
cash used in investing activities | |
$ | (21,334 | ) | |
$ | (34,300 | ) | |
$ | 12,966 | | |
| 37.8 | % |
| Net
cash provided by financing activities | |
$ | 2,135,025 | | |
$ | 385,000 | | |
$ | 1,750,025 | | |
| (454.6 | )% |
Net
Cash Used in Operating Activities
Cash
used in operating activities for the year ended December 31, 2021, reflects our $5,340,354 net loss for the
year adjusted for certain non-cash items including: (i) $2,889,567 of share-based compensation, (ii) $124,674 of
non-cash interest expense, (iii) $549,026 of net changes in our operating assets and liabilities, (iv) $16,958 of
impairment losses and (v) $149,350 loss on debt extinguishment.
Cash
used in operating activities for the year ended December 31, 2020, reflects our $4,670,255 net
loss for the year adjusted for certain non-cash items including: (i) $4,302,978 of share-based compensation,
(ii) $30,616 of non-cash interest expense, and (iii) $106,751 of net changes in our operating assets and
liabilities.
Net
Cash Used in Investing Activities
Cash
used in investing activities during the year ended December 31, 2021, consisted of our acquisition of fixed and intangible assets.
We used $34,300 to acquire intangible assets during the year ended December 31, 2020.
Net
Cash Provided by Financing Activities
For
the year ended December 31, 2021, net cash provided by financing activities of approximately $2,135,000 consisted
of (i) $1,573,000 of proceeds from the sale of our common stock and warrants, (ii) $525,000 of proceeds from the exercise
of common stock purchase warrants, (iii) $110,000 of proceeds from debt issuances and (iv) $70,000 received for the issuance of notes
payable, partially offset by $50,000 of repayments of outstanding debt and $93,000 payments of deferred offering costs.
For
the year ended December 31, 2020, cash from financing activities of $385,000 consisted of (i) approximately $48,000 of proceeds from
related party advances, (ii) $20,000 received from issuance of related party notes, (iii) $365,000 proceeds of third-party notes,
partially offset by repayment of approximately $48,000 of related party advances.
Future
Liquidity and Needs
We
have incurred significant operating losses and negative cash flows since inception. We have not been able to generate significant revenues
nor achieved profitability and may not be able to do so in the future. We do not expect to be profitable in the next several years, but
rather expect to incur additional operating losses. We have limited liquidity and capital resources and must obtain significant additional
capital resources in order to sustain our product development efforts, for acquisition of technologies and intellectual property rights,
for preclinical and clinical testing of our anticipated products, pursuit of regulatory approvals, acquisition of capital equipment,
laboratory and office facilities, establishment of production capabilities, for general and administrative expenses and other working
capital requirements. We have relied on cash balances and the proceeds from the offering of our securities, and exercise of outstanding
warrants to fund our operations.
We
intend to pursue opportunities to obtain additional funds through the future through the sale of our securities.
As
explained in the notes to our financial statements, there continues to be substantial doubt as to our ability
to continue as a going concern. The source, timing and availability of any future financing will depend principally upon market conditions,
interest rates and, more specifically, current and future progress in our exploratory, preclinical and clinical development programs.
Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things,
to delay, scale back or eliminate some or all of our research and product development programs, planned clinical trials, and/or our capital
expenditures or to license our potential products or technologies to third parties.
JOBS
Act
Please
see the section of this prospectus entitled “Prospectus Summary — Implications of Being an Emerging Growth Company.”
OUR
BUSINESS
Overview
We
are a development stage biomedical company seeking to develop, in-license, sub-license and commercialize products in both the pharmaceutical
and medical device areas. We have in-licensed four technologies
which form the core of our current development efforts.
Product
Development.
All
of our assets have been acquired from licenses as described below. As of the date of this prospectus, we plan to undertake further research
efforts on our preclinical assets. In the event that we are able to generate sufficient data from our preclinical studies, we will attempt
to file IND applications as we determine. There is no guarantee that we’ll be able to manufacture compliant with current good manufacturing
practices (cGMP), and even if we are able to comply, there can be no assurances that we’ll be able to manufacture significant enough
quantities to ever conduct a clinical trial. As of the date of this Prospectus, we have not submitted any INDs with the FDA for any
of our product candidates.
Our development pipeline focuses on three (3) therapeutic areas: infectious
diseases, oncology, and degenerative eye disease. Under these therapeutic areas, we are focusing on four (4) programs: (i) Rabies, (ii)
COVID 19 Vaccines in Kidney Failure Patients, (iii) Glioblastoma, and (iv) Degenerative Eye Diseases. Even if we are able to raise the
net proceeds described above, management has determined that it will still need to make a determination on what indications within those
four (4) programs to pursue as we will not have sufficient capital to pursue all of the below indications.
| Therapeutic
Area |
|
Candidate |
|
Indication |
|
Research
and Pre-Clinical |
|
Phase
1 |
|
Phase
2 |
|
Phase
3 |
| Infectious
Diseases |
|
IMT505 |
|
Rabies |
|
(1) |
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Infectious
Diseases |
|
COVID
Vaccine with IMT504 Adjuvant |
|
COVID
19 in Kidney Failure Patients |
|
(2) |
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Oncology |
|
CUBT906-
CD56 Monoclonal Antibody ADC |
|
Glioblastoma |
|
(2) |
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Degenerative
Eye Disease |
|
Metformin
Reformulation |
|
Age-Related
Macular Degeneration |
|
(1) |
|
|
|
|
|
|
| (1) | Each
of these therapeutics have undergone certain toxicology and pharmacokinetics animal studies.
Please see further description in “Product Development” below for a further description
of the development of each indicated therapeutic. |
| (2) | Each
of these therapeutics have not undergone pre-clinical development. Please see further description
in “Product Development” below for a further description of the development of
each indicated therapeutic. |
We
anticipate focusing on the following indications under our three (3) therapeutic areas:
Infectious
Diseases
Rabies
In
October 2020, we entered into an exclusive licensing and co-development agreement to develop a novel immunotherapy, IMT504, to
treat late-stage rabies from Mid-Atlantic BioTherapeutics, Inc. If successful IMT504 will be the first drug ever approved to treat rabies
in humans once the disease has passed the window in time where vaccination can prevent the onset of the disease and the disease has moved
into the brain. We plan on conducting further research and preclinical studies on IMT504 to determine if we will be able to file IND
applications with the FDA.
Our
Rabies treatment is a patented immunostimulatory agent to be administered after the window of time where current Rabies vaccines can
be effective, licensed on an exclusive basis from Mid Atlantic Biotherapeutics, a private biotechnology company. As a result of the relatively
low rates of Rabies in the United States and large number of affected people outside the United States, our path of development for this
treatment will likely be conducted outside of the U.S. which may raise additional challenges, and particularly so in the age of COVID-19.
As
of the date of this Prospectus, we have completed IND-enabling toxicology and pharmacokinetics in two species (monkeys and rates)
using clinical grade drug. We
now need to complete a manufacturing plan as part of our IND application process. Thereafter, we will need to manufacture clinical grade
drug in large enough quantities to conduct and complete our proposed clinical trial.
COVID-19
in Kidney Failure Patients
In
October of 2021 we entered into a licensing agreement with Mid-Atlantic BioTherapeutics, Inc. to license Mid-Atlantic’s COVID-19
vaccine which is composed of a recombinant S1 and S2 protein from SARS-CoV-2 plus an IMT504 adjuvant.
This
is a novel COVID-19 vaccine using IMT504 as an adjuvant; initially as a vaccine to protect kidney failure patients. Kidney failure patients,
whether recipients of transplants or on dialysis, are an extremely vulnerable population when it comes to infectious disease in general,
and specifically with respect to the COVID variations that have spread throughout the world. They appear to have received significantly
less protection against COVID infections than the rest of the vaccinated population at large. We believe that our novel vaccine and adjuvant
could provide additional protection for this vulnerable population. This asset is patent pending.
As
of the date of this Prospectus, we have not yet commenced pre-clinical development and we will need to complete animal studies
with toxicology pharmacokinetics and receive approval of our manufacturing plan as part of our IND application process.
Oncology
Glioblastoma
In
October of 2020 we entered into a worldwide exclusive agreement with the National Cancer Institute (NCI) a part of the National Institutes
of Health (NIH) to license and develop a novel Monoclonal Antibody Drug Conjugate to treat Glioblastoma. There are currently no
effective long-term treatments for glioblastoma.
Our
Glioblastoma treatment is a Monoclonal Antibody Drug Conjugate (MADC) utilizing a patented
CD56 monoclonal antibody conjugated with a cancer killing drug to treat newly diagnosed solid brain tumors. Glioblastoma patients
have poor outcomes as a group with life expectancy under 5 years and often considerably shorter periods of time. We will attempt to
deliver our MADC focally, that is directly to the tumor via a surgical route of administration to try to avoid the systemic toxicity
associated with cancer drugs which are potent enough to kill the tumor(s). We are currently in the process of testing and expanding
the cell lines sent to us by NCI as part of the license agreement and have identified facilities in the U.S., Ireland, and the
Netherlands, potentially for both the non-clinical and clinical grade manufacturing of the drug if and when we
determine that we are ready to begin manufacturing.
As
of the date of this Prospectus, we have not yet commenced pre-clinical development and we will need to complete animal studies
with toxicology pharmacokinetics and receive approval of our manufacturing plan as part of our IND application process.
Degenerative
Eye Diseases
In
February of 2021 we entered into a worldwide exclusive agreement with the National Eye Institute (NEI), a part of the National Institute
of Health (NIH), for inventions including the repurposing of Metformin to treat retinal degenerative diseases. The Company plans on repurposing
Metformin as a topical eye application (daily eye drop) and focusing on its development. We are targeting several different degenerative
eye diseases, none of which have an approved drug which is considered to provide significant benefits to patients. The largest disease
markets in this space are wet and dry AMD (age related macular degeneration), which dry AMD is currently our primary focus. Further indications
described below may be explored after further preclinical research and development. On March 15, 2022, we entered into a cooperative
research and development agreement (“CRADA”) with the NEI as the next step in commercializing our Metformin license. The
NEI will conduct clinical studies under their protocols, and we will provide the proprietary drug for the clinical studies. We will provide
funding not to exceed $115,000 for the clinical trials, with the balance paid by the NEI.
While
our current focus is on Intermediate Dry Macular Degeneration and Geographic Atrophy, the Company does have the right under the license
to pursue other indications with Metformin but has no plans to undertake any development related to such indications at this time.
As
of the date of this Prospectus, we have completed preliminary toxicology, pharmacokinetics and tolerance studies in one species
(rabbit) with a non-clinical grade drug. We will need to replicate these studies under Good Laboratory Practice conditions in rabbits
and potentially dogs and we will need to complete a manufacturing plan as part of our IND application process. Thereafter, we will need
to manufacture clinical grade drug in large enough quantities to conduct and complete the proposed clinical trial.
Intermediate
Dry Macular Degeneration and Geographic Atrophy
We
are primarily focusing on developing a treatment for Intermediate Dry Macular Degeneration and Geographic Atrophy (late-stage Dry
AMD) from our license of a pending patent with NEI at the NIH. There are currently no FDA approved drug treatments for either. The
main thrust of the invention(s) covered by our license is the use of reformulated Metformin, one of the worlds most prescribed drugs
to treat diabetes, into an eye drop to treat degenerative eye diseases. We have assembled a quality and regulatory and manufacturing
team, and have completed preliminary nonclinical grade animal toxicology and pharmacokinetics (PK) and have contracted for IND
enabling toxicology and PK testing.
Mechanisms
of Action
Metformin
(Degenerative Eye Disease) – Research from the National Eye Institute has shown that metformin can activate AMP activated
protein kinase (AMPK) activity, reduce extreme vascular endothelial growth factor (VEGF) secretion, and correct baseline calcium
levels in patient derived retinal pigment epithelium (RPE) cells. The new treatment indications will require reformulating the drug
into an eye drop, injectable or other topical delivery method to be able to deliver sufficient drug to the RPE layer to have a
therapeutic effect.
CUBT906
– CD56 Monoclonal Antibody ADC (Glioblastoma) – CUBT906 is a fully humanized CD56 monoclonal antibody carrying
a PBD (Pyrrolobenzodiazepine dimer) directly to the tumor site to kill the tumor by inhibiting tumor growth and migration of the tumor.
IMT504
(Rabies / COVID-19) – IMT504 is a synthetic immunotherapy that stimulates different kinds of cells of the immune system
in humans and has been studied as a vaccine adjuvant, as well as in cancer and infectious disease immunotherapies.
Licenses
Mid-Atlantic
BioTherapeutics, Inc. Immunotherapy for Symptomatic
Rabies
Effective
September 30, 2021, we received an exclusive license to a pharmaceutical compound IMT504 for the development of an immunotherapy for
symptomatic rabies. Pursuant to an amendment to the license entered into on October 13, 2021, the licensor will have a right to terminate
the agreement and accompanying license if we do not raise a minimum of $6.5 million of net proceeds within 180 days of the SEC declaring
our initial Form S-1 Registration Statement effective. The licensor previously had the right to terminate the agreement and accompanying
license if we failed to raise $1,000,000 by March 31, 2022, which was satisfied. The agreement and accompanying license are additionally
subject to termination in the event of a material breach of either party on 60 days’ notice with a right to cure. In exchange for
the license, we (i) issued the licensor 17,500 shares of Common Stock on the effective date, (ii) will be required to issue an
additional 16,250 shares of Common Stock upon the submission of an IND application to the FDA that is accepted, (iii) will issue
an additional 16,250 shares of Common Stock upon the successful completion of the first rabies clinical trial conducted pursuant
to such IND application and (iv) will pay half of all Net Profits (as described in the license) from the licensed products to licensor.
In the event we are required to issue the additional shares pursuant to the license, our shareholders may experience substantial dilution.
NIH
License L-009-2021-0 “Antibody-Drug Conjugates for targeting glioblastoma CD56 Positive”
Effective
October 15, 2020, we licensed US Provisional Patent Application No. 62/199,707, PCT Application No. PCT/US2016/044777, and US. Patent
No. 10,548,987 from the National Cancer Institute, whereby we received an exclusive evaluation license, for evaluation purposes only
and to make and use, but not sell materials or licensed products, for a term of two (2) years. We have a right to exercise an exclusive
option, upon submitting a written notice to the National Cancer Institute one month prior to the termination date, which will include
an application and commercial development plan and will initiate a three (3) month negotiation period to receive an exclusive commercial
license. In exchange for the license, we (i) paid a $5,000 up front license fee, and (ii) will be required to pay a $5,000 payment on
the one-year anniversary of effective date, which has been paid. The agreement expires 24 months from the effective date. Within
60 days of the termination or expiration of the agreement, unless a licensor exclusive or non-exclusive commercial patent license has
been executed for the licensed patents in the licensed field of use, we will be required to return all materials and licensed products
under the agreement to the licensor or certify their destruction. Further, the licensor has the right to terminate the agreement and
accompanying license at its sole option if they determine that we (i) fail to adhere to a required commercial evaluation plan contained
in Appendix E of the agreement (as described below), (ii) have not performed reasonable commercial efforts through certain benchmarks
set forth in Appendix D of the agreement (as described below), (iii) have willfully made a false statement or willfully omitted a material
fact in the license application or any report, (iv) have committed a material breach of a covenant or agreement contained in the agreement,
or (v) cannot reasonably satisfy unmet health and safety needs. In the event we are in default in the performance of any material obligation
under the license, including, but not limited to, the adherence to the commercial evaluation plan in Appendix X and/or the performance
of the benchmarks set forth in Appendix D, we will provide licensor with written notice within 30 days of such default. Upon written
approval that shall not be unreasonably withheld by licensor, we may be permitted to remedy such default within 60 days after the date
of such written notice. Notwithstanding, licensor will have the right to terminate if such default is not remedied within 90 days after
the date of such default.
We
will be required to provide annual updates regarding our progress under the license, including, without limitation, the benchmarks and
commercial development plan.
Benchmarks
required to be met in the license agreement
Under
our license with the National Cancer Institute, we agreed to meet certain benchmarks, which are contained in Appendix D to the license
as follows:
| 1. | Initiate
preclinical IND-enabling studies within 6 months of the Effective Date of the license agreement. |
| | | |
| 2. | Select
at least one lead ADC candidate within eighteen (18) months of the Effective Date of the
license agreement. |
| | | |
| 3. | Raise
at least a total of $500,000 within twenty-two (22) months of the Effective Date of the license
agreement. |
| | | |
| 4. | IND
submission within twenty-four (24) months of the Effective Date of the license agreement. |
Commercial
Development Plan required to be met in the license agreement
Under
our license with the National Cancer Institute, we agreed to a Commercial Development Plan with the licensor, which is contained in Appendix
E to the license. A summary of the Commercial Development Plan is as follows:
| 1. | Evaluate
m900 and m906 to further character the ADCs and determine their stability, solubility, etc. |
| | | |
| 2. | Select
one of the two antibodies for further development and select one or two leads for IND consideration
by the expiration of the license agreement. |
The
Commercial evaluation plan is also a generalized good faith estimate not a group of specific milestones. The commitment here is to demonstrate
the steps required to choose between the two monoclonals covered by the patent. We have already done that. The inventor on the patent,
dr. Dimiter Dimitrov has joined our SAB and had done a good bit of the characterization work while in his lab at NCI allowing us to move
directly to begin the manufacture and conjugation of the drug and the anti-body; and plan the preclinical animal studies which are expected
to be conducted by Nick Boulis at Emory in Q3 2022.
NIH
License L-088-20210 – “Druggable target to treat retinal degeneration”
Effective
February 2, 2021, we licensed US Provisional Patent Application No. 62/899,899 and PCT Application No. PCT/US2020/050540 from the National
Eye Institute (U.S. Department of Health and Human Services) whereby we received an exclusive license worldwide for therapeutics to treat
retinal degenerative diseases, including the right to sublicense, pursuant to certain restrictions for a term of three (3) years, subject
to an extension for the life of the licensed patents as described below. In the event we are in default in the performance of any
material obligations under the agreement and if the default is not remedied within 90 days after notice, licensor may terminate this
agreement and the accompanying license. Additionally, licensor may terminate or modify the agreement if it determines that we (i) are
not executing the commercial development plan contained in the agreement as Appendix E (as described below), (ii) have not achieved
certain benchmarks set forth in Appendix D of the agreement (as described below), (iii) have willfully made a false
statement or willful omission of a material fact in the license application or in any report required under the agreement, (iv) have
committed a material breach of a covenant or agreement contained in the agreement, (v) is not keeping the licensed products and processes
reasonably available to the public after commercial use commences, (vi) cannot reasonably satisfy unmet health and safety needs, (vii)
cannot reasonably justify a failure to comply with the domestic production requires contained in the agreement, or (viii) have been found
by a court to have violated federal antitrust laws in connection with the agreement. Further, we will have the unilateral right to terminate
the agreement or any licenses in any country or territory on 60 days’ notice. We will be required to provide annual updates
with our progress under the license, including, without limitation, the benchmarks and commercial development plan. The licensed
products relate to any direct ocular administered formulations of metformin – including injections to the eye, eye drops and other
topical formulations related to the licensed patents. In exchange for the license, we (i) paid $5,000 upon execution and an additional
past prosecution royalty payment of $8,500, (ii) are required to pay an annual royalty of $5,000 per year, (iii) are required to pay
3.5% of Net Sales related to the licensed assets, and (iv) may choose to extend the term for the life of the patents (which life of such
patents, which we will be able to ascertain if and when the patent is granted) underlying the licensed assets upon (i) payment of $45,000
and (ii) written evidence of commercially reasonable progress toward licensee (Company) sponsored clinical studies of a Licensed Product
(as defined in the license) and adherence with the Commercial Development Plan (as defined in the license). Additionally, we are required
to pay certain milestone royalties as follows: (i) $75,000 upon first Phase 2 Clinical Study for a licensed product in the licensed field
of use. (Retinal degenerative diseases in humans), (ii) $300,000 upon first completion of a Phase 3 Clinical Study for a licensed product
in licensed field of use, (iii) $600,000 upon FDA approval of the first licensed product in the licensed field of use, (iv) $100,000
for each first commercial sale in each of the following countries: USA, Canada, European Union (including U.K., and Asia (including Japan,
China, Korea and Australia).
Benchmarks
required to be met in the license agreement
Under
our license with the National Eye Institute, we agreed to meet certain benchmarks, which are contained in Appendix D to the license.
Notwithstanding, in the event that we deviate from the benchmarks, we will need to provide the licensor with suitable reasoning. Further,
we may amend the benchmarks from time to time upon approval from the licensor, which will not be unreasonably withheld by the licensor.
Additionally, the licensor may not unreasonably withhold approval of any request by us to extend the time periods of the benchmarks if
the request is supported by a reasonable showing of our diligence in our performance under the commercial Development Plan as described
below. The initial benchmarks are as follows (with defined terms having their meaning as set forth in the license):
| 1. | On
or before five (5) months from the Effective Date (February 2, 2021), initiate any pre-clinical
study activities, as needed, under target points 2.1 and 3.1 in the Commercial Development
Plan (described below). This has been completed by the Company. |
| | | |
| 2. | On
or before twenty-four (24) months from the Effective Date, complete a Phase 1 Clinical Study
for initiate a Phase 2 Clinical Study for treatment of a first indicated disease within the
Field of Use using a Licensed Product. |
| | | |
| 3. | On
or before thirty-six (36) months from the Effective Date, complete a Phase 2 Clinical Study
or initiate a Phase 3 Clinical Study for the treatment of a first indicated disease within
the Field of Use using a Licensed Product. |
| | | |
| 4. | On
or before forty-eight (48) months from the Effective Date, complete a First Commercial Sale
of a Licensed Product to treat a first indicated disease within a Field of Use. |
| | | |
| 5. | On
or before sixty (60) months from the Effective Date, initiate clinical studies for treatment
of an at least second indicated disease within the Field of Use using a Licensed Product. |
| | | |
| 6. | On
or before one hundred and twenty (120) months, complete a First commercial Sale of a Licensed
Product to treat at least a second indicated disease with the Field of Use. |
Commercial
Development Plan required to be met in the license agreement
Under
our license with the National Eye Institute, we agreed to a Commercial Development Plan with the licensor, which are contained in Appendix
E to the license. Notwithstanding, we may propose amendments to the Commercial Development Plan, which cannot be unreasonably denied
by the licensor. A summary of the initial Commercial Development Plan is as follows:
| 1. | Gap
analysis will be performed on the information provided by the National Eye Institute too
assess development requirements for pre-IND and IND preparation. |
| | | |
| 2. | We
are required to utilize certain consultants with sufficient training to perform certain chemistry,
manufacturing and control processes. |
| | | |
| 3. | Create
and analyze a clinical development strategy. |
| | | |
| 4. | Target
point 2.1 of the Commercial Development Plan sets forth certain process development, analytics
and formulation for first in human GMP manufacturing. |
| | | |
| 5. | Target
points 3.1 and 3.2 of the Commercial Development Plan set forth certain manufacturing, IND
and clinical initiation plans. |
| | | |
| 6. | Target
point 4.1 sets forth future manufacturing and development plans, including Phase 1. |
| | | |
| 7. | Target
point 4.2 through 7.1 sets forth future manufacturing and development plans, including potential
Phase 2, Phase 3, and NDA (New Drug Application) submissions |
Cooperative Research and Development Agreement
for Intramural-PHS Clinical Research
Under the CRADA, the NEI will assist in the evaluation
and of the Company’s proprietary ocular metformin in clinical studies for the treatment of AMD. The purpose of the CRADA is to
assist in commercializing our Metformin license. Pursuant to the terms of the CRADA, we are responsible for manufacturing drug and
delivering it in an acceptable form to the clinician. NEI is responsible for conducting the trial and collecting the data. The NEI
will conduct clinical studies under their protocols, and we will provide the proprietary drug for the clinical studies. We will provide
funding not to exceed $115,000 for the clinical trials, with the balance paid by the NEI.
The CRADA expires on March 15, 2025.
Under the terms of the CRADA, either party has
the right to unilaterally terminate the CRADA at any time by providing at least sixty (60) days written notice. In the event that we
terminate the CRADA, the NEI, at its option, may retain funds transferred to it before such termination. Additionally, in the event that
we terminate the CRADA before the completion of all approved or active protocols, we will supply enough drug to complete the protocols,
unless such termination was due to safety concerns.
IEM,
Inc. License US Patent # 8,287,505 –
“Ophthalmic Drop Dispensing Tip Assembly”
Effective
September 30, 2020, we received an option to pay $50,000 for an exclusive royalty-free license to US Patent #8,287,505 relating to an
ophthalmic drop dispending tip assembly. Pursuant to the license, we were able to exercise the option right at any time upon written
notice one month prior to September 30, 2021. We provided such notice prior to such date to extend the option period for an additional
six (6) months or until March 31, 2022 and in March of 2022, we additionally extended the option for another six (6) months or until
September 30, 2022. Upon such extensions we were required to pay $1,000 fee for each extension to licensor. We additionally
agreed to pay $1,800 of maintenance fees to the USPTO for the license as well as any future payments for maintenance and defense rights
of the patents. In the event we materially breach our obligations under the agreement and fail to cure within 30 days’ written
notice, the party providing us the option will have the right to terminate the agreement.
Mid-Atlantic
BioTherapeutics, Inc. COVID-19 vaccine License
Effective
October 1, 2021, we received an exclusive license to a pharmaceutical compound IMT504 for the development of a COVID-19 vaccine composed
of recombinant S1 and S2 proteins from SARS-CoV—2 plus IMT504 adjuvant. The licensor will have a right to terminate the agreement
and accompanying license if we have not raised $10,000,000 within 90 days of the SEC declaring our initial Form S-1 Registration Statement
effective to fund the development of projects related to the license (which will be overseen by a joint steering committee including
licensor and our personnel). Additionally, pursuant to an amendment to the license agreement entered into on December 31, 2021, the licensor
will have the right to terminate the agreement if we do not provide at least $10,000,000 for the initial funding of projects under the
license in a reasonable time frame to accomplish the initiation of the projects in a timely fashion. The agreement and accompanying license
are additionally subject to termination in the event of a material breach of either party on 60 days’ notice with a right to cure.
In exchange for the license, we (i) issued the licensor 31,250 shares of Common Stock on the effective date, (ii) will be required
to issue an additional 43,750 shares of Common Stock upon the submission of an IND application to the FDA that is accepted, and
(iii) will pay half of all Net Profits (as described in the license) from the licensed products to licensor. In the event we are required
to issue the additional shares pursuant to the license, our shareholders may experience substantial dilution.
Market
Infectious Diseases
Rabies
Rabies is a viral
disease that causes inflammation of the brain in humans and other mammals. Early symptoms can include fever and
tingling at the site of exposure. These symptoms are followed by one or more of the following symptoms: nausea, vomiting, violent
movements, uncontrolled excitement, fear of water, an inability to move parts of the body, confusion, and loss of consciousness.
Once symptoms appear, the result is virtually always death.
It is extremely rare in the U.S. when patients
do not get vaccinated in time. However unfortunately this is not the case outside of the U.S. particularly in large population
areas of the near and far east and northern Africa, which are poorly served by modern “western” medicine.
According
to the CDC, from 1960 to 2018, 127 human rabies cases were reported in the United States, with roughly a quarter resulting from dog bites
received during international travel. Of the infections acquired in the United States, 70% were attributed to bat exposures.
According
to the WHO, every year, more than 29 million people worldwide receive a post-bite vaccination. This is estimated to prevent hundreds
of thousands of rabies deaths annually. Globally, the economic burden of dog-mediated rabies is estimated at USD 8.6 billion per
year.
The
WHO reports that rabies is present on all continents, except Antarctica, with over 95% of human deaths occurring in the Asia and Africa
regions. Rabies is one of the Neglected Tropical Diseases (NTD) that predominantly affects poor and vulnerable populations who live in
remote rural locations. Approximately 80% of human cases occur in rural areas. Although effective human vaccines and immunoglobulins
exist for rabies, they are not readily available or accessible to those in need. According to the WHO, globally, rabies deaths are rarely
reported and children between the ages of 5–14 years are frequent victims.
Notwithstanding,
the rabies market worldwide contains no drug / vaccine which can be administered after the standard window for treatment of (sometimes
days, usually weeks, and occasionally a few months) and the disease has moved into the brain. There are no approved drugs anywhere in
the world that can treat patients after this window has closed.
COVID-19
COVID-19 is a contagious disease caused by severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease
has since spread worldwide, leading to an ongoing pandemic.
COVID-19 has been declared a pandemic by the World
Health Organization (WHO). As of November 3, 2021, more than 245 million people have been infected and COVID-19 has caused more
than 4.9 million deaths.
Many biopharmaceutical companies and academic
centers have been in a race to develop a prophylactic vaccine by using several platforms including mRNA, adenoviral vectors and recombinant
proteins. As of October 1, 2021, four vaccines have been approved by US or European regulatory authorities.
According to Kidney.org, there are an estimated
37 million people in the U.S. with some type of kidney disease. Further, according to niddk.nih.gov, approximately 800,000 people in
the U.S. are living with end stage kidney disease with 71% on dialysis and 29% with a kidney transplant.
Oncology
Glioblastoma
Glioblastoma is the most aggressive type of cancer
that begins within the brain. Initially, signs and symptoms of glioblastoma are nonspecific. They may include headaches, personality
changes, nausea, and symptoms similar to those of a stroke. Symptoms often worsen rapidly and may progress to unconsciousness.
The cause of most cases of glioblastoma is not
known. Uncommon risk factors include genetic disorders, such as neurofibromatosis and Li-Fraumeni syndrome, and previous radiation therapy.
Glioblastomas represent 15% of all brain tumors. They can either start from normal brain cells or develop from an existing low-grade
astrocytoma. The diagnosis typically is made by a combination of a CT scan, MRI scan, and tissue biopsy.
Despite maximum treatment, the cancer always
recurs. The typical duration of survival following diagnosis is 12–15 months, with fewer than 3–7% of people surviving
longer than five years. Without treatment, survival is typically three months. It is the most common cancer that begins within the
brain and the second-most common brain tumor, after meningioma. About 3 in 100,000 people in the U.S. develop the disease per year.
The average age at diagnosis is 64, and the disease occurs more commonly in males than females.
Globally,
over 241,000 people die each year as a result of brain or nervous system cancer, with Glioblastoma being the most common form of the
disease and the most common primary malignant form of brain cancer. According to an iHealthcare Analyst: GBM has an incidence
of two to three per 100,000 adults per year, and accounts for 52 percent of all primary brain tumors. Glioblastoma multiforme (GBM) is
the most common and deadly brain tumor in adults. The incidence of GBM in the USA and Europe is 2-3 per 100,000. By definition, an orphan
disease is one affecting 200,000 persons in the USA (one in every 1,500). In Europe, the definition is narrower, with fewer than five
in 10,000 (one in every 2,000) people affected. The global GBM drugs market is projected to reach nearly $1.8 billion by 2027 driven
by rising geriatric population, growing incidence of cases, and a rich clinical pipeline of new products. Despite technological
advances in surgery and radio-chemotherapy, glioblastoma remains largely resistant to treatment. Active biotech and pharma companies
in the markets include CSN Pharmaceuticals, Inc. (Nasdaq: CNSP), Intellia Therapeutics, Inc. (Nasdaq: NTLA), Anavex Life Sciences Corp.
(Nasdaq: AVXL), Bristol Myers Squibb (NYSE: BMY), and Clovis Oncology, Inc. (Nasdaq: CLVS). Almost all of the current attempts to treat
GBM involve attempts to expand the labels of drugs already approved to treat some other type of cancer, as standalone treatments or in
combination with existing chemotherapies.
Retinal
Degenerative Diseases
Nearly 10% of the world’s population
is over 60, increasing the prevalence of age-related macular degeneration. Dry AMD accounts for 80-90% of AMD cases, while wet AMD is
10-20% of cases. Currently there are no approved drug treatments for Dry AMD or Geographic Atrophy (late-stage dry AMD).
According
to eyewire.news, in 2019, annual anti-VEGF (Vascular Endothelial Growth Factor) sales reported for the treatment of retinal diseases
was estimated to exceed $11 billion in 2019 globally. The current AMD market is limited, comprising only five available drugs in the US, EU, and Japan and four
in China. A main drawback for all
these drugs and many gene therapies being developed for these indications is the requirement of continued periodic direct injections
into the eye which creates issues of compliance.
Despite
the significant benefits of existing therapeutic options, the need for frequent intravitreal injections is burdensome for both patients
and retinal specialists. Retinal practitioners surveyed by the American Society of Retinal Specialists responded that their three greatest
unmet needs are availability of long-acting sustained drug delivery, therapies that reduce treatment burden and new treatment mechanisms
of action. According to a 2019 study of patient interviews in the United States, France and Australia, the factors affecting adherence
from the patient perspective included the psychological burden of repeated intravitreal injections, the time burden of both treatment
and monitoring visits for both patients and caregivers.
Patents
The
intellectual property underlying our technology is covered by certain patents and patent applications licensed pursuant to our licensing
agreements as described above. The following table describes our patent portfolio and the rights contained thereunder.
| Program |
|
Country |
|
Appl.
No./ Patent No. |
|
Filing
Date |
|
Issuance
Date |
|
Recorded
Owner |
|
Owned
or Licensed by Curative Biotechnology |
|
Status |
|
Expiration |
| COVID-19 |
|
U.S. |
|
10/309,775
7,038,029 |
|
12/4/2002 |
|
5/2/2006 |
|
David
Horn, LLC |
|
Licensed |
|
Issued |
|
Standard
expiration Apr. 1, 2023 (+ 118 day PTA) |
| COVID-19 |
|
U.S. |
|
11/178,086
7,381,807 |
|
7/8/2005 |
|
6/3/2008 |
|
David
Horn, LLC |
|
Licensed |
|
Issued |
|
Standard
expiration Nov. 25, 2023 (+ 356 days PTA) |
| COVID-19 |
|
U.S. |
|
12/111,006
7,943,316 |
|
4/28/2008 |
|
5/17/2011 |
|
David
Horn, LLC |
|
Licensed |
|
Issued |
|
Standard
expiration Dec. 4, 2022 (+ 0 days PTA) |
| COVID-19 |
|
U.S. |
|
13/099,778
8,871,436 |
|
5/3/2011 |
|
10/28/2014 |
|
David
Horn, LLC |
|
Licensed |
|
Issued |
|
Standard
Expiration June 28, 2024 (+ 572 days PTA) |
| COVID-19 |
|
Australia |
|
2003250334
2003250334 |
|
5/30/2003 |
|
11/25/2005 |
|
David
Horn, LLC |
|
Licensed |
|
Issued |
|
4/20/2023 |
| COVID-19 |
|
European
Patent Convention |
|
03755959.8
1511845 |
|
5/30/2003 |
|
3/9/2005 |
|
David
Horn, LLC |
|
Licensed |
|
Issued |
|
5/30/2023 |
| COVID-19 |
|
India |
|
3773/DLNP72004
252038 |
|
11/29/2004 |
|
4/23/2012 |
|
David
Horn, LLC |
|
Licensed |
|
Issued |
|
11/29/2024 |
| COVID-19 |
|
Mexico |
|
2004/011937 |
|
11/30/2004 |
|
3/9/2005 |
|
David
Horn, LLC |
|
Licensed |
|
Issued |
|
11/30/2024 |
| COVID-19 |
|
New
Zealand |
|
20030536962
536962 |
|
11/25/2004 |
|
1/11/2007 |
|
David
Horn, LLC |
|
Licensed |
|
Issued |
|
11/25/2024 |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Retinal
Degeneration |
|
U.S. |
|
PCT/US
2020/050540 |
|
9/11/2020
|
|
N/A |
|
National
Institute of Health |
|
License |
|
Pending |
|
N/A |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Rabies |
|
U.S. |
|
10/309,775
7,038,029 |
|
12/4/2002 |
|
5/2/2006 |
|
David
Horn, LLC |
|
License |
|
Issued |
|
12/4/2022 |
| Rabies |
|
U.S. |
|
11/178,086
7,381,807 |
|
7/8/2005 |
|
6/3/2008 |
|
David
Horn, LLC |
|
License |
|
Issued |
|
7/8/2025 |
| Rabies |
|
U.S. |
|
12/111,006
7,943,316 |
|
4/28/2008 |
|
5/17/2011 |
|
David
Horn, LLC |
|
License |
|
Issued |
|
4/28/2028 |
| Rabies |
|
U.S. |
|
13/099,778
8,871,436 |
|
5/3/2011 |
|
10/28/2014 |
|
David
Horn, LLC |
|
License |
|
Issued |
|
5/3/2031 |
| Rabies |
|
Australia |
|
2003250334
2003250334 |
|
5/30/2003 |
|
11/25/2004 |
|
David
Horn, LLC |
|
License |
|
Issued |
|
5/30/2023 |
| Rabies |
|
European
Patent Convention |
|
03755959.8
1511845 |
|
5/30/2003 |
|
3/9/2005 |
|
David
Horn, LLC |
|
License |
|
Issued |
|
5/30/2023 |
| Rabies |
|
India |
|
3773/DLNP7
2004
252038 |
|
11/29/2004 |
|
4/23/2012 |
|
David
Horn, LLC |
|
License |
|
Issued |
|
11/29/2024 |
| Rabies |
|
Mexico |
|
2004/011937 |
|
11/30/2004 |
|
3/9/2005 |
|
David
Horn, LLC |
|
License |
|
Issued |
|
11/30/2024 |
| Rabies |
|
New
Zealand |
|
20030536962
536962 |
|
11/25/2004 |
|
1/11/2007 |
|
David
Horn, LLC |
|
License |
|
Issued |
|
11/24/2024 |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Glioblastoma |
|
U.S. |
|
15/747/620 |
|
1/25/2018 |
|
2/4/2020 |
|
National
Cancer Institute |
|
License |
|
Issued |
|
10/25/2036 |
Note
– All issued patents contain composition of matter claims, as well as process claims and claims for the treatment of disease.
When
appropriate, we will continue to seek patent protection for inventions in our core technologies and in ancillary technologies that support
our core technologies or which we otherwise believe will provide us with a competitive advantage. We will accomplish this by filing and
maintaining patent applications for discoveries we make, either alone or in collaboration with scientific collaborators and strategic
partners. In addition, we plan to obtain licenses or options to acquire licenses to patent filings from other individuals and organizations
that we anticipate could be useful in advancing our research, development, and commercialization initiatives and our strategic business
interest.
Consultant
Agreement with Sohn Health Strategies
On
September 27, 2021, the Company entered into an agreement with Sohn Health Strategies, LLC (“Sohn Health”) to serve as a
special advisor to the Board of Directors and CEO of the Company for a term of two (2) years from the effective date. Sohn Health will
provide the following services: (i) monthly review sessions with the CEO, (ii) assistance in quarterly joint steering committees, including
meetings with the National Eye Institute Joint Steering Committee and Infectious Disease Joint Steering Committee, (iii) serve as Chairperson
and participate in the Infections Disease and National Eye institute Joint Steering Committees (iii) preparation of minutes for both
Steering Committees, and (iv) attending key scientific meetings as a representative of the Company. As compensation, we agreed to issue
the consultant (i) 625 shares of Common Stock on the grant date and (ii) an option to purchase 1% of the issued and outstanding
capital stock of the Company on a fully diluted basis, or an aggregate of 20,202 options to purchase Common Stock. The option
has an exercise price of $44.00 per share, a term of 10 years, and vests (i) 50% on issuance and (ii) 50% on the one (1) year
anniversary of the issuance date, subject to Sohn Health’s continued service to the Company. Additionally, upon the Company completing
a reverse stock split and capital raising transaction of at least $5,000,000, Sohn Health will receive additional options such that the
total option including such additional options will remain as 1% of the fully diluted capital stock of the Company. As of the date of
this prospectus, the consultant is currently providing services to the Company.
Manufacturing
We
do not own or intend to own or operate any manufacturing facilities. We currently and anticipate that we will continue to rely on third-party
contract manufacturing organizations (“CMOs”) to manufacture and supply our preclinical and potentially clinical materials
to be used during the development of our drug candidates. As our product candidates advance through development, we expect to enter into
longer-term commercial supply agreements with key suppliers and manufacturers to fulfill and secure our production needs. There can
be no assurances that we will be able to successfully manufacturer our product candidates pursuant to cGMP or that we will be able to
produce sufficient quantities to advance our preclinical product candidates to clinical trials.
Competition
Drug
development is highly competitive and subject to rapid and significant technological advancements. Our ability to compete will greatly
depend upon our ability to complete necessary preclinical, IND applications, clinical trials and other related regulatory
approval processes, and successfully market any product that we may successfully develop. The key competitive factors that will affect
the commercial success of any product candidate for which we may receive marketing approval include efficacy, safety, tolerability, dosing
convenience, price, coverage and reimbursement.
We
are at a significant disadvantage at competing with our various product candidates because we are still in the preclinical stage of research
with all of our product candidates. As a result, other companies looking to create products for the same indications would likely be
further along in their drug development and would likely have access to greater resources given our limited operating history and going
concern opinion from our independent registered public accounting firm. It is still too early to determine the competitive landscape
of our product candidates at this time.
Our
current and potential future competitors are diverse. There are many public and private biopharmaceutical companies, universities, governmental
agencies and other research organizations actively engaged in the research and development of products that may be similar to our product
candidates or address similar markets. In addition, the number of companies seeking to develop and commercialize products and therapies
similar to our product candidates may increase during the period of our product development.
Intellectual
Property
Our
commercial success depends in part on our ability to (i) obtain and maintain proprietary protection to protect our current and future
product candidates, novel discoveries, product development technologies, improvements, and know-how; (ii) preserve the confidentiality
of our trade secrets and confidential information; (iii) maintain our co-development agreements and licenses for exclusive commercial
rights to intellectual property, including patent rights co-owned with third parties; (iv) defend and enforce our proprietary rights,
including our patents; and (v) operate without infringing valid and enforceable patents and other proprietary rights of third parties.
We
seek to protect our proprietary position by, among other methods, filing or in-licensing U.S. and foreign patents and patent applications
related to technology, inventions and improvements that are important to the development and implementation of our business. As for the
product candidates we develop and plan to commercialize, as a normal course of business, we generally have pursued, or intend to pursue,
composition and therapeutic use patents, as well as patents directed to dosing regimens and additional prospective indications. We also
rely, as needed, on trademarks, trade secrets, copyright protection, know-how, continuing technological innovation and confidential information
to develop and maintain our proprietary position. We also will pursue data exclusivity, market exclusivity, and other regulatory exclusivities,
as applicable and available.
Regardless
of the coverage we seek under our existing patent families, there is always a risk that an alteration to our products, methods, or processes
may provide sufficient basis for a competitor to avoid infringement claims. In addition, the coverage claimed in a patent application
can be significantly reduced before a patent is issued, and courts can reinterpret patent scope after issuance. Moreover, many jurisdictions,
including the United States, permit third parties to challenge issued patents in administrative proceedings, which may result in further
narrowing or even cancellation of patent claims. Moreover, we cannot provide any assurance that any patents will be issued from our pending
or any future applications or that any current or future issued patents will adequately protect our intellectual property.
While
we seek broad coverage under our existing patent applications, there is always a risk that an alteration to the products or processes
may provide sufficient basis for a competitor to avoid infringing our patent claims. In addition, patents, if granted, expire and we
cannot provide any assurance that any patents will be issued from our pending or any future applications or that any potentially issued
patents will adequately protect our products or product candidates.
Individual
patents extend for varying periods depending on the date of filing of the patent application or the date of patent issuance and the legal
term of patents in the countries in which they are obtained. Generally, patents issued for regularly filed applications in the United
States are granted a term of 20 years from the earliest effective non-provisional filing date. In addition, in certain instances, a patent
term can be extended to recapture a period due to delay by the USPTO in issuing the patent as well as a portion of the term effectively
lost as a result of the FDA regulatory review period. However, as to the FDA component, the restoration period cannot be longer than
five years and the total patent term including the restoration period must not exceed 14 years following FDA approval. The duration of
foreign patents varies in accordance with provisions of applicable local law, but typically is also 20 years from the earliest effective
non-provisional filing date. However, the actual protection afforded by a patent varies on a product-by-product basis, from country to
country, and depends upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related
extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patent.
Our
commercial success will also depend in part on not infringing upon the proprietary rights of third parties. It is uncertain whether the
issuance of any third-party patent would require us to alter our development or commercial strategies for our products, if approved,
or processes, or to obtain licenses or cease certain activities. Our breach of any license agreements or failure to obtain a license
to proprietary rights that we may require to develop or commercialize our future products may have an adverse impact on us. If third
parties prepare and file patent applications in the United States that also claim technology to which we have rights, we may have to
participate in interference or derivation.
Trade
Secrets and Confidentiality
We
rely, in some circumstances, on trade secrets and other confidential information to protect our unpatented technology. However, trade
secrets can be difficult to protect. We seek to protect our trade secrets and proprietary technology and processes, in part, by entering
into non-disclosure and confidentiality agreements with our employees, consultants, collaborators, scientific advisors, suppliers, contractors
and other third parties. In addition, we enter into consulting agreements and employment agreements that require employees and consultants
to assign to us any inventions, trade secrets or know-how that they develop while employed or contracted by us.
We
also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises
and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations
and systems, agreements or security measures may be breached, and our trade secrets and other proprietary information may be disclosed.
We may not have adequate remedies for any breach and could lose our trade secrets and other proprietary information through such a breach.
In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our consultants,
contractors or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related
or resulting trade secrets, know-how and inventions.
Government
Regulation and Product Approval
The
FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among
other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging,
storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting
of drugs and biologics such as those we are developing.
Small
molecule drugs are subject to regulation under the Food, Drug, and Cosmetic Act (“FDCA”) and biological products are additionally
subject to regulation under the Public Health Service Act (“PHSA”) and both are subject to additional federal, state, local
and foreign statutes and regulations. We, along with third-party contractors, will be required to navigate the various preclinical, clinical
and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek
approval or licensure of our product candidates.
U.S.
Biopharmaceuticals Regulation
The
process required by the FDA before drug and biologic product candidates may be marketed in the United States generally involves the following:
| |
● |
completion
of extensive preclinical laboratory tests and animal studies performed in accordance with applicable regulations, including the FDA’s
Good Laboratory Practice (“GLP”) regulations; |
| |
● |
submission
to the FDA of an investigational new drug application (“IND”) which must become effective before clinical trials may
begin; |
| |
● |
approval
by an independent institutional review board or ethics committee at each clinical site before the trial is commenced; |
| |
● |
performance
of adequate and well-controlled human clinical trials in accordance with FDA’s Good Clinical Practice (“GCP”) regulations
to establish the safety and efficacy of a drug candidate and safety, purity and potency of a proposed biologic product candidate
for its intended purpose; |
| |
● |
preparation
of and submission to the FDA of a new drug application (“NDA”) or biologics license application (“BLA”),
as applicable, after completion of all pivotal clinical trials; |
| |
● |
satisfactory
completion of an FDA Advisory Committee review, if applicable; |
| |
● |
a
determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review; |
| |
● |
satisfactory
completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced
to assess compliance with current Good Manufacturing Practice requirements, or cGMPs, and of selected clinical investigation sites
to assess compliance with GCPs; and |
| |
● |
FDA
review and approval of an NDA, or licensure of a BLA, to permit commercial marketing of the product for particular indications for
use in the United States. |
Preclinical
and Clinical Development
Prior
to beginning the first clinical trial with a product candidate, we must submit an IND to the FDA. An IND is a request for authorization
from the FDA to administer an investigational new drug product to humans. The central focus of an IND submission is on the general investigational
plan and the protocol or protocols for preclinical studies and clinical trials. The IND also includes results of animal and in vitro
studies assessing the toxicology, pharmacokinetics, pharmacology and pharmacodynamic characteristics of the product, chemistry, manufacturing
and controls information, and any available human data or literature to support the use of the investigational product. An IND must become
effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the
FDA, within the 30-day period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be
placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial
can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.
Clinical
trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in
accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation
in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the
parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND
must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore,
an independent institutional review board for each site proposing to conduct the clinical trial must review and approve the plan for
any clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed.
Regulatory authorities, the institutional review board or the sponsor may suspend a clinical trial at any time on various grounds, including
a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives.
Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a
data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based
on access to certain data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for
subjects or other grounds, such as no demonstration of efficacy.
For
purposes of biopharmaceutical development, human clinical trials are typically conducted in three sequential phases that may overlap
or be combined:
| |
● |
Phase
1. The investigational product is initially introduced into patients with the target disease or condition. These studies are
designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans,
the side effects associated with increasing doses, and, if possible, to gain early indications of effectiveness. |
| |
|
|
| |
● |
Phase
2. The investigational product is administered to a limited patient population to evaluate the preliminary efficacy, optimal
dosages and dosing schedule and to identify possible adverse side effects and safety risks. |
| |
|
|
| |
● |
Phase
3. The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically
significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical
trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to
provide an adequate basis for product approval |
In
some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain
more information about the product. These so-called “Phase 4” studies may be made a condition to approval of the application.
Concurrent with clinical trials, companies may complete additional animal studies and develop additional information about the characteristics
of the product candidate, and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP
requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among
other things, must develop methods for testing the identity, strength, quality and purity of the final product, or for biologics, the
safety, purity and potency. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to
demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
During all phases of clinical development, regulatory
agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical study investigators. The FDA
or the sponsor or its data safety monitoring board may suspend a clinical study at any time on various grounds, including a finding that
the research patients or patients are being exposed to an unacceptable health risk. Similarly, an institutional review board can suspend
or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the institutional
review board’s requirements or if the biological product candidate has been associated with unexpected serious harm to patients.
There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries.
Sponsors of clinical trials of FDA-regulated products are required to register and disclose certain clinical trial information, which
is publicly available at www.clinicaltrials.gov.
NDA/BLA
Submission and Review
Assuming
successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development,
nonclinical studies and clinical trials are submitted to the FDA as part of an NDA or BLA, as applicable, requesting approval to market
the product for one or more indications. The application must include all relevant data available from pertinent preclinical studies
and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating
to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things. The submission of an application
requires payment of a substantial application user fee to the FDA, unless a waiver or exemption applies. The FDA has sixty days from
the applicant’s submission to either issue a refusal to file letter or accept the application for filing, indicating that it is
sufficiently complete to permit substantive review.
Once
an NDA or BLA has been accepted for filing, the FDA’s goal is to review standard applications within 10 months after it accepts
the application for filing, or, if the application qualifies for priority review, six months after the FDA accepts the application for
filing. In both standard and priority reviews, the review process is often significantly extended by FDA requests for additional information
or clarification. The FDA reviews an NDA to determine whether a drug is safe and effective for its intended use and a BLA to determine
whether a biologic is safe, pure and potent. FDA also reviews whether the facility in which the product is manufactured, processed, packed
or held meets standards designed to assure and preserve the product’s identity, safety, strength, quality, potency and purity.
The FDA may convene an advisory committee to provide clinical insight on application review questions. Before approving an NDA or BLA,
the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application
unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure
consistent production of the product within required specifications. Additionally, before approving an application, the FDA will typically
inspect one or more clinical sites to assure compliance with GCPs. If the FDA determines that the application, manufacturing process
or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional
testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the
application does not satisfy the regulatory criteria for approval.
After
the FDA evaluates an application and conducts inspections of manufacturing facilities where the investigational product and/or its drug
substance will be manufactured, the FDA may issue an approval letter or a Complete Response letter. An approval letter authorizes commercial
marketing of the product with specific prescribing information for specific indications. A Complete Response letter will describe all
of the deficiencies that the FDA has identified in the application, except that where the FDA determines that the data supporting the
application are inadequate to support approval, the FDA may issue the Complete Response letter without first conducting required inspections,
testing submitted product lots and/or reviewing proposed labeling. In issuing the Complete Response letter, the FDA may recommend actions
that the applicant might take to place the application in condition for approval, including requests for additional information or clarification,
which may include the potential requirement for additional clinical studies. The FDA may delay or refuse approval of an application if
applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and
surveillance to monitor safety or efficacy of a product.
If
regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the
indicated uses for which such product may be marketed. For example, the FDA may approve the application with a risk evaluation and mitigation
strategy (“REMS”), to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known
or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their
safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution
methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to
proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval
if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace.
The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety
and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing
studies.
Expedited
Development and Review Programs
The
FDA offers a number of expedited development and review programs for qualifying product candidates. The fast track program is intended
to expedite or facilitate the process for reviewing new products that meet certain criteria. Specifically, new products are eligible
for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential
to address unmet medical needs for the disease or condition. Fast track designation applies to the combination of the product and the
specific indication for which it is being studied. The sponsor of a fast track product has opportunities for frequent interactions with
the review team during product development and, once an NDA or BLA is submitted, the product may be eligible for priority review. A fast
track product may also be eligible for rolling review, where the FDA may consider for review sections of the NDA or BLA on a rolling
basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the application,
the FDA agrees to accept sections of the application and determines that the schedule is acceptable, and the sponsor pays any required
user fees upon submission of the first section of the application.
A
product intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy designation
to expedite its development and review. A product can receive breakthrough therapy designation if preliminary clinical evidence indicates
that the product, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
The designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance beginning as
early as Phase 1 and an organizational commitment to expedite the development and review of the product, including involvement of senior
managers.
Any
marketing application for a drug or biologic submitted to the FDA for approval, including a product with a fast track designation and/or
breakthrough therapy designation, may be eligible for other types of FDA programs intended to expedite the FDA review and approval process,
such as priority review and accelerated approval. A product is eligible for priority review if it has the potential to provide a significant
improvement in the treatment, diagnosis or prevention of a serious disease or condition. Priority review designation means the FDA’s
goal is to take action on the marketing application within six months of the 60-day filing date.
Additionally,
products studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated
approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit,
or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict
an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of
the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally
require the sponsor to perform adequate and well-controlled post-marketing clinical studies to verify and describe the anticipated effect
on irreversible morbidity or mortality or other clinical benefit. In addition, the FDA currently requires as a condition for accelerated
approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.
Fast
track designation, breakthrough therapy designation and priority review do not change the standards for approval but may expedite the
development or approval process. Even if a product qualifies for one or more of these programs, the FDA may later decide that the product
no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
Orphan
Drug Act
Under
the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which
is a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United
States for which there is no reasonable expectation that the cost of developing and making available in the United States a drug or biologic
for this type of disease or condition will be recovered from sales in the United States for that drug or biologic. Orphan drug designation
must be requested before submitting an NDA or BLA. After the FDA grants orphan drug designation, the generic identity of the therapeutic
agent and its potential orphan use are disclosed publicly by the FDA. The orphan drug designation does not convey any advantage in, or
shorten the duration of, the regulatory review or approval process.
If
a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation,
the product is entitled to orphan drug exclusive approval (or exclusivity), which means that the FDA may not approve any other applications,
including a full NDA or BLA, to market the same drug or biologic for the same indication for seven years, except in limited circumstances,
such as a showing of clinical superiority to the product with orphan drug exclusivity or if the FDA finds that the holder of the orphan
drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients
with the disease or condition for which the drug was designated. Orphan drug exclusivity does not prevent the FDA from approving a different
drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other
benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA or BLA application fee.
A
designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which
it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines
that the request for designation was materially defective.
Post-Approval
Requirements
Any
products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including,
among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and
distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new
indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing user fee requirements,
under which the FDA assesses an annual program fee for each product identified in an approved NDA or BLA. Biopharmaceutical manufacturers
and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic
unannounced inspections by the FDA and certain state agencies for compliance with cGMPs, which impose certain procedural and documentation
requirements upon us and our third-party manufacturers. Changes to the manufacturing process are strictly regulated, and, depending on
the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and
correction of any deviations from cGMPs and impose reporting requirements upon us and any third-party manufacturers that we may decide
to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain
compliance with cGMPs and other aspects of regulatory compliance.
The
FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product
reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity
or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved
labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition
of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:
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restrictions
on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls; |
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fines,
warning or untitled letters or holds on post-approval clinical studies; |
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refusal
of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product
approvals; |
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product
seizure or detention, or refusal of the FDA to permit the import or export of products; |
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consent
decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; |
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mandated
modification of promotional materials and labeling and the issuance of corrective information; |
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the
issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other
safety information about the product; or |
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injunctions
or the imposition of civil or criminal penalties. |
The
FDA closely regulates the marketing, labeling, advertising and promotion of biopharmaceutical products. A company can make only those
claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the
approved label. However, companies may share truthful and not misleading information that is otherwise consistent with a product’s
FDA approved labeling. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising
and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the
product’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical
specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA
does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications
on the subject of off-label use of their products.
Biosimilars
and Exclusivity
The
Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively the “ACA”),
signed into law in 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”),
which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed
reference biological product.
Biosimilarity,
which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of
safety, purity and potency, can be shown through analytical studies, animal studies and a clinical study or studies. Interchangeability
requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the
same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual,
the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety
risks or risks of diminished efficacy relative to exclusive use of the reference biologic. However, complexities associated with the
larger, and often more complex, structures of biological products, as well as the processes by which such products are manufactured,
pose significant hurdles to implementation of the abbreviated approval pathway that are still being worked out by the FDA.
Under
the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference
product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12
years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may
still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s
own preclinical data and data from adequate and well-controlled clinical studies to demonstrate the safety, purity and potency of its
product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it
is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which
are governed by state pharmacy law.
The
BPCIA is complex and continues to be interpreted and implemented by the FDA. In addition, recent government proposals have sought to
reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions,
have also been the subject of recent litigation. As a result, the ultimate impact, implementation, and impact of the BPCIA is subject
to significant uncertainty.
Hatch-Waxman
Amendments and Exclusivity
Section
505 of the FDCA describes three types of marketing applications that may be submitted to the FDA to request marketing authorization for
a new drug. A Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and efficacy. A 505(b)(2)
NDA is an application that contains full reports of investigations of safety and efficacy but where at least some of the information
required for approval comes from investigations that were not conducted by or for the applicant and for which the applicant has not obtained
a right of reference or use from the person by or for whom the investigations were conducted. This regulatory pathway enables the applicant
to rely, in part, on the FDA’s prior findings of safety and efficacy for an existing product, or published literature, in support
of its application. Section 505(j) establishes an abbreviated approval process for a generic version of approved drug products through
the submission of an Abbreviated New Drug Application (“ANDA”). An ANDA provides for marketing of a generic drug product
that has the same active ingredients, dosage form, strength, route of administration, labeling, performance characteristics and intended
use, among other things, to a previously approved product. ANDAs are termed “abbreviated” because they are generally not
required to include preclinical (animal) and clinical (human) data to establish safety and efficacy. Instead, generic applicants must
scientifically demonstrate that their product is bioequivalent to, or performs in the same manner as, the innovator drug through in vitro,
in vivo or other testing. The generic version must deliver the same amount of active ingredient(s) in the same amount of time as the
innovator drug and can often be substituted by pharmacists under prescriptions written for the reference listed drug. In seeking approval
for a drug through an NDA, applicants are required to list with the FDA each patent with claims that cover the applicant’s drug
or a method of using the drug. Upon approval of a drug, each of the patents listed in the application for the drug is then published
in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in
the Orange Book can, in turn, be cited by potential competitors in support of approval of an ANDA or 505(b)(2) NDA.
Upon
submission of an ANDA or a 505(b)(2) NDA, an applicant must certify to the FDA that (1) no patent information on the drug product that
is the subject of the application has been submitted to the FDA; (2) such patent has expired; (3) the date on which such patent expires;
or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the application
is submitted. Generally, the ANDA or 505(b)(2) NDA cannot be approved until all listed patents have expired, except where the ANDA or
505(b)(2) NDA applicant challenges a listed patent through the last type of certification, also known as a paragraph IV certification.
If the applicant does not challenge the listed patents, or indicates that it is not seeking approval of a patented method of use, the
ANDA or 505(b)(2) NDA application will not be approved until all of the listed patents claiming the referenced product have expired.
The
FDA also cannot approve an ANDA or 505(b)(2) application until all applicable non-patent exclusivities listed in the Orange Book for
the branded reference drug have expired. For example, a pharmaceutical manufacturer may obtain five years of non-patent exclusivity upon
NDA approval of a new chemical entity, or NCE, which is a drug containing an active moiety that has not been approved by FDA in any other
NDA. An “active moiety” is defined as the molecule responsible for the drug substance’s physiological or pharmacologic
action. During that five-year exclusivity period, the FDA cannot accept for filing (and therefore cannot approve) any ANDA seeking approval
of a generic version of that drug or any 505(b)(2) NDA that relies on the FDA’s approval of the drug, provided that that the FDA
may accept an ANDA four years into the NCE exclusivity period if the ANDA applicant also files a paragraph IV certification.
Drugs
and biologics can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to
existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or
patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request”
for such a study.
Federal
and State Fraud and Abuse, Data Privacy and Security, and Transparency Laws and Regulations
In
addition to FDA restrictions on marketing of pharmaceutical products, federal and state healthcare laws and regulations restrict business
practices in the biopharmaceutical industry. These laws may impact, among other things, our current and future business operations, including
our clinical research activities, and proposed sales, marketing and education programs and constrain the business or financial arrangements
and relationships with healthcare providers and other parties through which we market, sell and distribute our products for which we
obtain marketing approval. These laws include anti-kickback and false claims laws and regulations, data privacy and security, and transparency
laws and regulations, including, without limitation, those laws described below.
The
U.S. federal Anti-Kickback Statute prohibits any person or entity from, among other things, knowingly and willfully offering, paying,
soliciting or receiving remuneration to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase,
lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term “remuneration”
has been broadly interpreted to include anything of value. The U.S. federal Anti-Kickback Statute has been interpreted to apply to arrangements
between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Although there
are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and
safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases
or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. Several courts have interpreted
the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals
of federal healthcare covered business, the statute has been violated.
A
person or entity does not need to have actual knowledge of this statute or specific intent to violate it in order to have committed a
violation. In addition, the government may assert that a claim including items or services resulting from a violation of the U.S. federal
Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act or the civil monetary
penalties laws.
Federal
civil and criminal false claims laws, including the federal civil False Claims Act, which can be enforced by individuals through civil
whistleblower and qui tam actions, and civil monetary penalties laws, prohibit any person or entity from, among other things, knowingly
presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, using or causing to
be made or used a false record or statement material to a false or fraudulent claim to the federal government. A claim includes “any
request or demand” for money or property presented to the U.S. government. Several pharmaceutical and other healthcare companies
have been prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would
bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of the companies’
marketing of products for unapproved, and thus non-reimbursable, uses.
The
federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created additional federal criminal statutes
that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private
third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false,
fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Also, many
states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state
programs, or, in several states, apply regardless of the payor.
In
addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct
our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and
their respective implementing regulations, impose specified requirements on certain types of individuals and entities relating to the
privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s security
standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities,
which include certain healthcare providers, healthcare clearinghouses and health plans, that create, receive, maintain or transmit individually
identifiable health information in connection with providing a service for or on behalf of a covered entity. HITECH also increased the
civil and criminal penalties that may be imposed against covered entities, 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 HIPAA and seek attorney’s
fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information
in certain circumstances, many of which are not pre-empted by HIPAA, differ from each other in significant ways and may not have the
same effect, thus complicating compliance efforts.
The
federal Physician Payments Sunshine Act requires certain manufacturers of 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 annually
to the Centers for Medicare & Medicaid Services (“CMS”), information related to payments or other transfers of value
made to physicians, as defined by such law, and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations
to report annually to CMS ownership and investment interests held by physicians and their immediate family members.
We
may also be subject to state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary
compliance guidelines and the relevant compliance guidance promulgated by the federal government, state laws that require drug manufacturers
to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures
or drug pricing, and state and local laws that require the registration of pharmaceutical sales representatives.
Because
of the breadth of these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some
of our business activities could be subject to challenge under one or more of such laws. If our operations are found to be in violation
of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject to significant
criminal, civil and administrative penalties including damages, fines, imprisonment, disgorgement, additional reporting requirements
and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with
these laws, contractual damages, reputational harm, diminished profits and future earnings, exclusion from participation in government
healthcare programs and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate
our business and our results of operations. To the extent that any of our products are sold in a foreign country, we may be subject to
similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance,
anti-fraud and abuse laws, implementation of corporate compliance programs, reporting of payments or transfers of value to healthcare
professionals, and additional data privacy and security requirements.
Coverage
and Reimbursement
The
future commercial success of our product candidates, if approved, will depend in part on the extent to which third-party payors, such
as governmental payor programs at the federal and state levels, including Medicare and Medicaid, private health insurers and other third-party
payors, provide coverage of and establish adequate reimbursement levels for our product candidates. Third-party payors generally decide
which products they will pay for and establish reimbursement levels for those products. In particular, in the United States, no uniform
policy for coverage and reimbursement exists. Private health insurers and other third-party payors often provide coverage and reimbursement
for products based on the level at which the government, through the Medicare program, provides coverage and reimbursement for such products,
but also on their own methods and approval process apart from Medicare determinations. Therefore, coverage and reimbursement can differ
significantly from payor to payor.
In
the United States, the European Union (“EU”), and other potentially significant markets for our product candidates, government
authorities and third-party payors are increasingly attempting to limit or regulate the price of products, particularly for new and innovative
products, which often has resulted in average selling prices lower than they would otherwise be. Further, the increased emphasis on managed
healthcare in the United States and on country and regional pricing and reimbursement controls in the EU will put additional pressure
on product pricing, reimbursement and usage. These pressures can arise from rules and practices of managed care groups, judicial decisions
and laws and regulations related to Medicare, Medicaid and healthcare reform, pharmaceutical coverage and reimbursement policies and
pricing in general.
Third-party
payors are increasingly imposing additional requirements and restrictions on coverage and limiting reimbursement levels for products.
For example, federal and state governments reimburse products at varying rates generally below average wholesale price. These restrictions
and limitations influence the purchase of products. Third-party payors may limit coverage to specific products on an approved list, or
formulary, which might not include all of the FDA-approved products for a particular indication. Similarly, because certain of our product
candidates are physician-administered, separate reimbursement for the product itself may or may not be available. Instead, the administering
physician may only be reimbursed for providing the treatment or procedure in which our product is used. Third-party payors are increasingly
challenging the price and examining the medical necessity and cost-effectiveness of products, in addition to their safety and efficacy.
We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our
product candidates, in addition to the costs required to obtain the FDA approvals. Our product candidates may not be considered medically
necessary or cost-effective. A payor’s decision to provide coverage for a product does not imply that an adequate reimbursement
rate will be approved. Adequate third-party payor reimbursement may not be available to enable us to realize an appropriate return on
our investment in product development. Legislative proposals to reform healthcare or reduce costs under government insurance programs
may result in lower reimbursement for our product candidates, if approved, or exclusion of our product candidates from coverage and reimbursement.
The cost containment measures that third-party payors and providers are instituting and any healthcare reform could significantly reduce
our revenue from the sale of any approved product candidates.
Healthcare
Reform
The
United States and some foreign jurisdictions are considering enacting or have enacted a number of additional legislative and regulatory
proposals to change the healthcare system in ways that could affect our ability to sell our product candidates profitably, if approved.
Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems
with the stated goals of containing healthcare costs, improving quality and expanding access. In the United States, the pharmaceutical
industry has been a particular focus of these efforts, which include major legislative initiatives to reduce the cost of care through
changes in the healthcare system, including limits on the pricing, coverage, and reimbursement of pharmaceutical and biopharmaceutical
products, especially under government-funded healthcare programs, and increased governmental control of drug pricing.
There
have been several U.S. government initiatives over the past few years to fund and incentivize certain comparative effectiveness research,
including creation of the Patient-Centered Outcomes Research Institute under the ACA. It is also possible that comparative effectiveness
research demonstrating benefits in a competitor’s product could adversely affect the sales of our product candidates.
The
ACA became law in March 2010 and substantially changed the way healthcare is financed by third-party payors, and significantly impacts
the U.S. pharmaceutical industry. Among other measures that may have an impact on our business, the ACA established an annual, nondeductible
fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents; a new Medicare Part D coverage
gap discount program; and a new formula that increased the rebates a manufacturer must pay under the Medicaid Drug Rebate Program. Additionally,
the ACA extended manufacturers’ Medicaid rebate liability, expands eligibility criteria for Medicaid programs, and expanded entities
eligible for discounts under the Public Health Service Act. At this time, we are unsure of the full impact that the ACA will have on
our business.
There
has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices. Specifically, there
have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other
things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform
government program reimbursement methodologies for drugs. At the federal level, the Trump administration’s budget proposal for
fiscal year 2021 includes a $135 billion allowance to support legislative proposals seeking to reduce drug prices, increase competition,
lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic and biosimilar drugs. Additionally, the
Trump administration previously released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that
contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs,
incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers.
The U.S. Department of Health and Human Services has solicited feedback on some of these measures and has implemented others under its
existing authority. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage plans the option to use step therapy
for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019. Congress
and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control
drug costs. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical
and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access
and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and
bulk purchasing. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine
which drugs and suppliers will be included in their healthcare programs. Furthermore, there has been increased interest by third party
payors and governmental authorities in reference pricing systems and publication of discounts and list prices. These measures could reduce
future demand for our products or put pressure on our pricing.
Foreign
Regulation
In
order to market any product outside of the United States, we would need to comply with numerous and varying regulatory requirements of
other countries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial
sales and distribution of our product candidates. For example, in the EU, we must obtain authorization of a clinical trial application
(“CTA”) in each member state in which we intend to conduct a clinical trial. Whether or not we obtain FDA approval for a
drug, we would need to obtain the necessary approvals by the comparable regulatory authorities of foreign countries before we can commence
clinical trials or marketing of the drug in those countries. The approval process varies from country to country and can involve additional
product testing and additional administrative review periods. The time required to obtain approval in other countries might differ from
and be longer than that required to obtain FDA approval. Regulatory approval in one country does not ensure regulatory approval in another,
but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others.
Further,
some countries outside of the United States, including the EU member states, Switzerland and the United Kingdom, have also adopted data
protection laws and regulations, which impose significant compliance obligations. In the EU, the collection and use of personal health
data is governed by the provisions of the General Data Protection Regulation (“GDPR”). The GDPR became effective on May 25,
2018, repealing its predecessor directive and increasing responsibility and liability of pharmaceutical companies in relation to the
processing of personal data of EU subjects. The GDPR, together with the national legislation of the EU member states governing the processing
of personal data, impose strict obligations and restrictions on the ability to process personal data, including health data from clinical
trials and adverse event reporting. In particular, these obligations and restrictions concern potentially burdensome documentation requirements,
granting certain rights to individuals to control how we collect, use, disclose, retain and process information about them, the information
provided to the individuals, the transfer of personal data out of the EU, security breach notifications, and security and confidentiality
of the personal data. The processing of sensitive personal data, such as physical health condition, may impose heightened compliance
burdens under the GDPR and is a topic of active interest among foreign regulators. In addition, the GDPR provides for more robust regulatory
enforcement and fines of up to €20 million or 4% of the annual global revenue of the noncompliant company, whichever is greater.
Data protection authorities from the different EU member states may interpret the GDPR and national laws differently and impose additional
requirements, which add to the complexity of processing personal data in the EU. Guidance on implementation and compliance practices
are often updated or otherwise revised.
Employees
We
have four (4) employees as of January 9, 2023. As a virtually distributed company, we maintain
a small number of employees that oversee the outside contractors and consultants responsible for specific projects and services. We currently
have outside CRO’s, CMO’s, KOL’s, accountants, and legal personnel performing services under the supervision of our
employees. While the Company intends to hire and retain additional employees as needed if and when we are able to grow as an organization,
it anticipates continuing to use the services of outside consultants and contractors and to maintain its near virtual structure.
Corporate
Information
Our principal executive offices are located at 1825
NW Corporate Blvd Suite 110, Boca Raton, FL 33431; our telephone number is (561)-907-8990; our corporate website is located at www.curativebiotech.com.
No information found on our company’s website is part of this Prospectus.
We
were incorporated in the state of Nevada on June 29th, 1995, as Frozen Assets, Inc. Subsequently the Company changed
its name to Growth Industries, Inc. in March 1998, Fragrance Express, Inc. in June 1998, National Boston Medical in
October 1998, Storage Innovation Technologies in May 2004, and Connectyx Technologies in October 2007, and as of October 31, 2007
reincorporated in the state of Florida. In April 2017, the Company voluntarily dissolved its wholly owned subsidiary USA Medical Monitoring,
LLC (“USA Medical”), which was a Florida Limited Liability Company. In May 2019, the Company voluntarily dissolved its wholly
owned subsidiary Connectyx Technologies Corp. (“CTP”), which was a Florida Corporation. The Company remains active in the
state of Florida. On November 23, 2020, the Company changed its name to Curative Biotechnology, Inc.
DESCRIPTION
OF SECURITIES
General
Our authorized capital stock consists of 1,100,000,000
shares of Common Stock, $0.0001 par value per share, and 200,000,000 shares of preferred stock, $0.0001 par value per share. As of January
9, 2023, there were (i) 1,448,177 shares of our Common Stock issued and outstanding, (ii) 227,000 shares of Series B Preferred
Stock issued and outstanding and (iii) 30,000,000 shares of Series C Preferred Stock issued and outstanding.
Set
forth below is a summary description of all of the material terms of our securities, including those being registered hereunder. These
descriptions are qualified their entirety by reference to our amended and restated articles of incorporation, bylaws and forms of
warrants, each of which is filed as an exhibit to the Prospectus, of which this prospectus forms a part.
Units in this Offering
Each Unit being offered in this offering consists
of (i) one share of Common Stock and (ii) one Warrant, each whole Warrant exercisable for one share of common stock at an exercise price
of $9.00 per share (based on the reverse stock split ratio as described on the cover page of this prospectus). The Warrants have
a term of five (5) years from the date of issuance. The Common Stock and Warrants that are part of the Units are immediately separable
and will be issued separately in this offering, although they will have been purchased together in this offering.
Common
Stock
Voting
Each
holder of record of Common Stock shall have the right to one vote for each share of Common Stock registered in their name on the books
of the Corporation on all matters submitted to a vote of shareholders except as the right to exercise such vote may be limited by the
provisions of the Company’s Articles of Incorporation.
Dividends
The
holders of Common Stock shall be entitled to such dividends as may be declared by the Board of Directors from time to time, provided
that required dividends, if any, on the Preferred Stock have been paid or provided for.
Liquidation
Preference
In
the event of the liquidation, dissolution, or winding up, whether voluntary or involuntary of the Corporation, the assets and funds of
the Corporation available for distribution to shareholders and remaining after the payment to holders of Preferred Stock of the amounts
(if any) to which they are entitled, shall be divided and paid to the holders of the Common Stock according to their respective shares.
Warrants
The
Warrants will be issued as part of the Units in the offering pursuant to this Prospectus. For each Unit purchased, each purchaser will
receive one (1) Warrant to purchase one (1) share of Common Stock.
The
following is a brief summary of certain terms and conditions of the Warrants and is subject in all respects to the provisions contained
in the Warrants.
Form.
The Warrant will be issued as part of the Units, and each whole Warrant shall be exercisable for one share of common stock. You should
review a copy of the form of Warrant, which will be attached as Exhibit 4.19 to this Registration Statement, for a complete description
of the terms and conditions of the Warrants.
Exercisability.
The Warrants are exercisable at any time after their original issuance and at any time up to the date that is five years after their
original issuance. The Warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed
exercise notice and, at any time a registration statement registering the issuance of the shares of common stock underlying the Warrants
under the Securities Act is effective and available for the issuance of such shares, or an exemption from registration under the Securities
Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of shares of Common
Stock purchased upon such exercise. If a registration statement registering the issuance of the shares of Common Stock underlying the
Warrants under the Securities Act is not effective or available and an exemption from registration under the Securities Act is not available
for the issuance of such shares, the holder may elect to exercise the Warrant through a cashless exercise, in which case the holder would
receive upon such exercise the net number of shares of Common Stock determined according to the formula set forth in the Warrant. No
fractional shares of Common Stock will be issued in connection with the exercise of a Warrant. In lieu of fractional shares, we will
pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price.
Exercise
Limitation. A holder will not have the right to exercise any portion of the Warrant if the holder (together with its affiliates) would
beneficially own in excess of 4.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise,
as such percentage ownership is determined in accordance with the terms of the warrants. However, any holder may increase or decrease
such percentage to any other percentage not in excess of 9.99%, provided that any increase in such percentage shall not be effective
until 61 days following notice from the holder to us.
Exercise
Price; Adjustments. Each Warrant is exercisable at a price of $9.00 per whole share (based on the reverse stock split ratio
as described on the cover page of this prospectus), subject to adjustment. The exercise price, and the number of shares underlying the
Warrants is subject to customary adjustments in the event of subsequent financings, stock dividends and distributions, stock splits,
stock combinations, reclassifications or similar events affecting our shares of Common Stock, distributions of assets, including cash,
stock or other property to our stockholders, and Fundamental Transactions to be defined in the Warrants.
Subject to certain
exemptions outlined in the Warrant, for a period until the later of: (i) two years from the date of issuance of the Warrant, or (ii)
on the date no Warrants remain outstanding, if the Company issues or sells or is deemed to have sold or issued at an effective price
per share less than the exercise price of the Warrant then in effect (a “Dilutive Issuance”), the exercise price of the
Warrant shall be reduced to equal the effective price per share in such Dilutive Issuance; provided, however, that in no event shall
the exercise price of the Warrant be reduced to an exercise price lower than $3.00 (50% of the public offering price).
On the date that is 90 calendar days immediately following the initial issuance date of the Warrants, the exercise price of the
Warrants will adjust to be equal to (if such amount is less than the exercise price then in effect) 100% of the lowest closing price
of the Company’s Common Stock on a trading day occurring during the ninety (90) calendar days following the date of issuance
(the “Reset Price”). The lowest Reset Price is $3.50.
Redemption.
The Warrants will be subject to redemption at a
redemption price of $0.01 per Warrant commencing six (6) months after issuance subject to the condition that the volume weighted
average price of the Company’s Common Stock exceeds 200% of the initial exercise price for twenty (20) consecutive trading days
and subject to certain other conditions set forth in the Warrants.
Transferability.
Subject to applicable laws, a Warrant in book entry form may be transferred at the option of the holder through the facilities of the
Depository Trust Company and Warrants in physical form may be transferred upon surrender of the Warrant to the Warrant Agent together
with the appropriate instruments of transfer. Pursuant to a warrant agency agreement between us and the Warrant Agent, the Warrants initially
will be issued in book-entry form and will be represented by one or more global certificates deposited with The Depository Trust Company
(“DTC”) and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.
Fundamental
Transactions. In the event of a fundamental transaction, as described in the 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 Warrants will be entitled to receive upon exercise of the Warrants the kind and amount of securities, cash or other property
that the holders would have received had they exercised the warrants immediately prior to such fundamental transaction.
Exchange
Listing. There is no established public trading market for the Warrants, and there is no assurance that a market will develop. We
have applied to have the warrants listed on the NYSE American under the symbol “CUBT WS”. We will not consummate this offering
unless our Warrants are approved for listing on NYSE American.
Rights
as a Stockholder. Except as otherwise provided in the Warrants or by virtue of such holder’s ownership of shares of our Common
Stock, the holder of a Warrant does not have the rights or privileges of a holder of our Common Stock, including any voting rights, until
the holder exercises the Warrant.
Warrant Agent. Issuer
Direct Corporation will be the warrant agent for our Warrants. Issuer Direct Corporation’s address is One Glenwood Ave, Suite 1001,
Raleigh, NC 27603; its telephone number is (919) 481-4000.
Governing
Law. The Warrants are governed by New York law.
Underwriter
Warrants
We have agreed to issue
to Aegis Capital Corp., or its designees warrants to purchase up to a total of 5.0% of the shares of Common Stock sold in this
offering (excluding the shares sold through the exercise of the over-allotment option). Such warrants and underlying shares of Common
Stock are included in this prospectus.
The following is a brief
summary of certain terms and conditions of the warrants and is subject in all respects to the provisions contained in the warrants.
Form. Each warrant will
be exercisable for one share of common stock. You should review a copy of the form of the underwriter warrant, which will be attached
as Exhibit 4.18 to this Registration Statement, for a complete description of the terms and conditions of the warrant.
Exercisability.
The warrants are exercisable commencing on a date which is six (6) months from the commencement of sales of the offering under this
prospectus and expiring on a date which is five (5) years from the commencement of sales in the offering. No fractional shares of Common
Stock will be issued in connection with the exercise of a warrant. In lieu of fractional shares, we will pay the holder an amount in
cash equal to the fractional amount multiplied by the exercise price.
Exercise
Price; Adjustments. The warrants are exercisable at a price of $7.50 per whole share (based on the reverse stock split ratio
as described on the cover page of this prospectus), subject to adjustment. The exercise price, and the number of shares underlying the
warrants is subject to customary adjustments in the event of stock dividends, stock splits, stock combinations, reclassifications or
similar events affecting our shares of Common Stock.
Transferability. The
holder agrees may not: (a) sell, transfer, assign, pledge or hypothecate this warrant for a period of one hundred eighty (180) days following
the issuance date to anyone other than: (i) the holder or an underwriter, placement agent, or a selected dealer participating in the
offering, or (ii) a bona fide officer or partner of holder or of any such underwriter, placement agent or selected dealer, in each case
in accordance with FINRA Conduct Rule 5110(g)(1), or (b) for a period of one hundred eighty (180) days following the issuance date of
the warrant, cause the warrant or the securities issuable hereunder to be the subject of any hedging, short sale, derivative, put or
call transaction that would result in the effective economic disposition of the warrant or the securities hereunder, except as provided
for in FINRA Rule 5110(g)(2). After 180 days of issuance, transfers to others may be made subject to compliance with or exemptions from
applicable securities laws.
Rights as a Stockholder.
Except as otherwise provided in the warrants or by virtue of such holder’s ownership of shares of our Common Stock, the holder
does not have the rights or privileges of a holder of our Common Stock, including any voting rights, until the holder exercises the warrant.
Governing Law. The warrants
are governed by New York law.
Series
A Preferred Stock
The
Articles of Incorporation have a class of Preferred Stock designated as Series A Preferred Stock. Prior to the date hereof, all of the
shares of Series A Preferred Stock have been converted into Common Stock of the Company. Previously, the Company had authorized 134,109,750
shares of Series A Preferred Stock which have been deducted from the number of shares of Preferred Stock that the Company is entitled
to designate, authorize and issue, pursuant to its Articles of Incorporation.
Series
B Preferred Stock
The
Articles of Incorporation have a class of Preferred Stock designated as Series B Preferred Stock. The Company has authorized 1,000,000
shares of Series B Preferred Stock. As of the date hereof, the Company has issued 439,000 shares of Series B Preferred Stock,
of which 227,000 are currently outstanding as of January 9, 2023.
Voting
Except
as otherwise required by law, each holder of record of the Series B Preferred Stock shall be entitled to notice of any and all meetings
of the shareholders of the Corporation and shall be entitled to one (1) vote for each full share of Common Stock into which each share
of Series B Preferred Stock registered in his/her/its name on the books of the Corporation would be convertible on the record date for
any matter submitted to the shareholders of the Corporation for a vote, or, if no such record date is established, at the date such vote
is taken or any written consent of shareholders is solicited.
Further,
so long as any share of Series B Preferred Stock remains outstanding, in addition to any other vote or consent of shareholders required
by law or the Article of Incorporation of the Company, the vote or consent of the holders of at least 50. L% of the shares of Series
B Preferred Stock at the time outstanding, voting together as a single class, given in person or by proxy, either in writing without,
a meeting or by vote at any meeting called for the purpose, shall be necessary for effecting or validating (i) any change that
would adversely affect Series B Preferred Stock, (ii) the creation and issuance of securities senior to the rights, preferences, and
privileges of the Series B Preferred Stock, and (iii) extraordinary corporate events, including mergers, except where the
Series B Preferred Stock remains outstanding post-merger with its same rights, preferences, and privileges, or the Series B Preferred
stock is converted into preferred securities of the surviving entity in the merger not having less favorable rights, preferences, privileges
and voting power. As a result of the foregoing, we may not be able (i) to enter into certain transactions or (ii) create a senior class
of preferred stock, each without the approval of the Series B Preferred Stock holders.
Dividends
The
holders of the Series B Preferred Stock are not entitled to receive dividends on account of their Series B Preferred Stock.
Liquidation
Preference
In
the event of any liquidation, dissolution or winding up of the affairs of the Corporation, whether voluntary or otherwise, after payment
or provision for payment of the debts and other liabilities of the Corporation, the holders of the Series B Preferred Stock shall be
entitled to receive, prior to the holders of any Series B Junior Stock (as defined in the Article of Incorporation of the Company) and/or
Series B Parity Stock (as defined in the Article of Incorporation of the Company) and prior and in preference to any distribution of
the assets or surplus funds of the Corporation to the holders of any other shares of stock of the Corporation by reason of their ownership
of such stock, an amount equal to $1.00 per share with respect to each share of Series B Preferred Stock.
Conversion
Series
B Preferred Stock is convertible into shares of Common Stock as follows. The Conversion price for the Series B Preferred Stock is $3.00
per share.
Each
share of Series B Preferred Stock shall be convertible at the option of the holder in whole or in part, at the option of the holder
thereof, into that number of fully paid and non-assessable shares of Common Stock as may be purchased for the Conversion Price based
on the aggregate purchase price paid for the shares of Series B Preferred Stock (the “Series B Conversion Right”). The
Series B Conversion Right shall be exercised by a holder submitting written notice to the Corporation informing the Corporation of
his/her/its intent to exercise its Series B Conversion Right, specifying the date for such conversion (the “Series B
Conversion Date”) and identify which shares of Series B Preferred Stock such holder has elected to be converted into
Common Stock in accordance with the Series B Conversion Right.
In
addition, Series B Preferred Stock is subject to mandatory conversion. In the event that there be a Fundamental Change (as defined in
the Company’s Articles of Incorporation), the Series B Preferred Stock will automatically convert into that number of shares of
Common Stock as may be purchased for the Conversion Price, calculated as of the close of business the day immediately prior to such Fundamental
Change, based on the aggregate purchase price paid for the shares of Series B Preferred Stock.
Redemption
Subject
at all times to the Series B Conversation Right set forth above, the issued and outstanding shares of Series B Preferred Stock shall
be redeemable, in whole or in part, at the option of the Corporation by resolution of the Board of Directors, from time to time and at
any time, commencing any time after the date of issuance of the Series B Preferred Stock as follows. The redemption price per share of
Series B Preferred Stock shall be equal to the greater of: (i) one hundred and twenty five percent (125%) of the purchase price paid
for such share or (ii) the book value for such share as determined by an independent auditing firm.
Series
C Preferred Stock
The
Articles of Incorporation have a class of Preferred Stock designated as Series C Preferred Stock. The Company has authorized 30,000,000
shares of Series C Preferred Stock. As of the date hereof, the Company has issued 30,000,000 shares of Series C Preferred Stock, all
of which are currently outstanding and fully vested as of January 9, 2023.
Voting
Except
as otherwise required by law, each holder of Series C Preferred Stock is entitled to notice of any and all meetings of the shareholders
of the Corporation and shall be entitled to ten (10) votes for each full share of Common Stock on an as converted basis on the record
date for any matter submitted to the shareholders of the Corporation for a vote, or, if no such record date is established, at the date
such vote is taken or any written consent of shareholders is solicited.
Further,
so long as any share of Series C Preferred Stock remains outstanding, in addition to any other vote or consent of shareholders required
by law or the Article of Incorporation of the Company, the vote or consent of the holders of at least 50.1% of the shares of
Series C Preferred Stock at the time outstanding, voting together as a single class, given in person or by proxy, either in writing without,
a meeting or by vote at any meeting called for the purpose, shall be necessary for effecting or validating any change that would adversely
affect Series C Preferred Stock and in order for the Company to consummate what the Articles of Incorporation of the Company define as
Extraordinary Corporate Transactions.
Dividends
The
holders of the Series C Preferred Stock shall not be entitled to receive dividends on account of their Series C Preferred Stock.
Liquidation
Preference
In
the event of any liquidation, dissolution or winding up of the affairs of the Corporation, whether voluntary or involuntary or otherwise,
after payment or provision for payment of the debts and other liabilities of the Corporation, the holders of the Series C Preferred Stock
shall be entitled to receive, prior to the holders of any Series C Junior Stock (as defined in the Articles of Incorporation of the Company)
and/or Series C Parity Stock (as defined in the Articles of Incorporation of the Company) and prior and in preference to any distribution
of the assets or surplus funds of the Corporation to the holders of any other shares of stock of the Corporation by reason of their ownership
of such stock, an amount per share equal to the Conversion Rate described immediately below with respect to each share of Series C Preferred
Stock.
Conversion
The
Series C Preferred Stock shall be convertible into shares of Common Stock, as follows.
All
of the issued and outstanding shares of Series C Preferred Stock (the “Total Series C Shares”) shall collectively be convertible
into thirty percent (30%) of the total issued and outstanding shares of Common Stock at the time of such conversion (the “Conversion
Rate”) without any additional consideration by the holders to effectuate the conversion. For the avoidance of doubt, and as an
example, in the event of a conversion of Series C Preferred Stock, Series C Preferred Shareholders whose shares have vested will own
no more than 30% of all Common Stock post conversion, and the remaining 70% of Common Stock will be held by Common Stock shareholders.
Each
share of Series C Preferred Stock that has vested is voluntarily convertible in whole or in part, at the option of the holder thereof,
into that number of fully paid and non-assessable shares of Common Stock as may be converted pursuant to the Conversion Rate for the
shares of Series C Preferred Stock.
Further,
in the event Fundamental Change (as described in the Article of Incorporation of the Company), all Series C Preferred Stock shall automatically
vest, regardless of any longer vesting schedule set forth in an award document, and will, upon acceleration of vesting, automatically
convert into that number of shares of Common Stock as may be issued at the Conversion Rate described above.
All
of the holders of the Series C Preferred Stock have agreed to convert their shares of Series C Stock for Common Stock immediately prior
to the closing of the offering contemplated by this Prospectus.
Common
Stock Purchase Warrants
As of October 20, 2022, the Company had an
aggregate of 176,246 Common Stock purchase warrants issued and outstanding with a range of exercise prices from $0.0001 to $80.00
per share and an average weighted exercise price of $31.86 per share, consisting of:
| Description of Securities |
|
Exercise Price |
|
|
Expiration Date |
|
Price Adjustment |
| Consultant / Employee Warrants |
|
|
|
|
|
|
|
|
| 10,000 Warrants |
|
$ |
40.00 |
|
|
5/20/2026 |
|
Stock Splits and Dividends |
| 12,500 Warrants |
|
$ |
80.00 |
|
|
6/11/2024 |
|
Stock Splits and Dividends |
| 1,250 Warrants (1) |
|
$ |
49.60 |
|
|
7/14/2024 |
|
Stock Splits and Dividends |
| Offering Warrants |
|
|
|
|
|
|
|
|
| 1,000 Warrants |
|
$ |
20.00 |
|
|
12/3/2023 |
|
Stock Splits, Dividends and Fundamental Transactions |
| 12,500 Warrants |
|
$ |
44.00 |
|
|
5/21/2026 |
|
Stock Splits and Dividends |
| 312 Warrants |
|
$ |
60.00 |
|
|
7/9/2024 |
|
Stock Splits and Dividends |
| 7,500 Warrants |
|
$ |
60.00 |
|
|
8/18/2024 |
|
Stock Splits and Dividends |
| 2,777 Warrants |
|
$ |
56.00 |
|
|
8/19/2024 |
|
Stock Splits and Dividends |
| 1,008 Warrants |
|
$ |
44.00 |
|
|
11/12/2024 |
|
Stock Splits and Dividends |
| 30,365 Warrants |
|
$ |
36.00 |
|
|
Dec. 2024 |
|
Stock Splits and Dividends |
| 30,365 Warrants |
|
$ |
60.00 |
|
|
Dec. 2024 |
|
Stock Splits and Dividends |
| 66,666 Warrants |
|
$ |
0.0001 |
|
|
3/4/2027 |
|
N/A |
Of the warrants listed above, the 66,666 warrants
that expire on 3/4/2027, are subject to an increase in the number of shares underlying such warrants upon an offering of $7,200,000 or
greater in equity or debt securities of the Company at a price per share which multiplied by 75% is less than $20.00 per share.
Accordingly, based on the assumed offering price and reverse split ratio of 1-for-400 as set forth on the cover page of this Prospectus,
these warrants would adjust in number such that the number of shares of common stock exercisable under the warrant will increase to 296,293
shares, with no adjustment to the exercise price on a reverse stock split. Notwithstanding, upon the effective trading of the
reverse stock split, as described on the cover page of this Prospectus, the number of shares underlying such warrant will be proportionately
reduced.
Common Stock Purchase Options
On August 26, 2021, the Company’s Board approved
our 2021 Equity Incentive Plan. The plan was approved by our shareholders on October 8, 2021. The plan is described below under the heading
“Securities authorized for issuance under equity compensation plans”.
As of January 9, 2023, the Company has issued
options to purchase 18,641 shares of Common Stock and 2,500 shares of restricted Common Stock under our 2021 Equity Incentive Plan.
On
September 27, 2021, the Company issued Sohn Health Strategies, LLC, a consultant a non-qualified Common Stock purchase option to purchase
1% of the issued and outstanding capital stock of the Company on a fully diluted basis, or an aggregate of 20,202 options at September
27, 2021. The option has an exercise price of $44.00 per share, a term of 10 years, and vests (i) 50% on issuance and (ii) 50%
on the one (1) year anniversary of the issuance date, subject to the consultant’s continued service to the Company. Additionally,
upon the Company completing a reverse stock split and capital raising transaction of at least $5,000,000, the consultant will receive
additional options such that the total option including such additional options will remain as 1% of the fully diluted capital stock
of the Company. As of the date of this prospectus, the consultant is currently providing services to the Company.
Registration Rights
On August 9, 2021, pursuant to a settlement agreement,
the Company issued 5,000 shares of Common Stock with such shares having piggyback registration rights, with such rights not including
participation in this registration statement without underwriter approval.
Between August 18, 2021 and December 14, 2021, the
Company sold 41,651 shares of Common Stock and warrants to purchase 41,651 shares of Common Stock to investors. The shares
of Common Stock have piggyback registration rights, with such rights not including participation in this registration statement without
underwriter approval.
The Company granted piggyback registration
rights to the investor holder of the original issue discount senior secured debenture and shares underlying common stock purchase
warrants issued in the offering on March 4, 2022, with such rights not including participation in this registration statement
provided that prior notice is provided to the investor.
Choice
of Forum
Our
amended and restated Bylaws provides that, unless we consent in writing to the selection of an alternative forum, the State of Florida
is the exclusive forum for:
| ● |
any
derivative action or proceeding brought on our behalf; |
| |
|
| ● |
any
action asserting a claim of breach of a fiduciary duty; |
| |
|
| ● |
any
action asserting a claim against us arising pursuant to any provision of the Florida Business Corporation Act (“FBCA”),
our amended and restated certificate of incorporation or our amended and restated bylaws; or |
| |
|
| ● |
any
action asserting a claim against us that is governed by the internal affairs doctrine. |
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, in connection with any action, a court could find the choice of forum provisions contained in our
amended and restated Bylaws to be inapplicable or unenforceable in such action. These provisions would not apply to suits brought
to enforce a duty or liability created by the Exchange Act, Securities Act or any other claim for which the federal courts have exclusive
or concurrent jurisdiction. Any person or entity purchasing or otherwise acquiring any interest in our securities shall be deemed to
have notice of and consented to these provisions. Our exclusive forum provision will not relieve us of our duties to comply with the
federal securities laws and the rules and regulations thereunder, and our shareholders will not be deemed to have waived our compliance
with these laws, rules and regulations.
The
provisions of the FBCA, our amended and restated Bylaws could have the
effect of discouraging others from attempting hostile takeovers and may also have the effect of preventing changes in our management.
It is possible that these provisions could make it more difficult to accomplish transactions that stockholders may otherwise deem to
be in their best interests.
Transfer
Agent
Issuer
Direct Corporation is the transfer agent for our Common Stock. Issuer Direct Corporation’s address is One Glenwood Ave, Suite 1001,
Raleigh, NC 27603; its telephone number is (919) 481-4000; its website is issuerdirect.com. No information found on Issuer Direct Corporation’s
website is part of this Registration Statement.
PROPERTIES
Currently,
the Company utilizes a virtual office space at 1825 NW Corporate Blvd, Suite 110, Boca Raton, FL 3343 at a cost of $99 per month on a
month-to-month basis. We feel that our office space is adequate for our current and future needs as we are a virtually distributed company
with our employees and consultants around the USA.
LEGAL
PROCEEDINGS
We
are not currently subject to any material legal proceedings.
MARKET
PRICE OF AND DIVIDENDS ON THE REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market
Information
Our
common shares are quoted on the OTC Pink under the symbol CUBT. Any over-the-counter market quotations reflect inter-dealer prices,
without retail mark-up, mark-down or commission and may not necessarily represent actual transactions.
Holders
As
of January 9, 2023, we had approximately 215 record holders of our Common Stock. Because many of our shares of Common Stock are
held by brokers and other institutions on behalf of stockholders, we are unable to estimate the total number of beneficial holders represented
by these record holders, but it is well in excess of the number of record holders.
Dividend
Policy
We
have never declared or paid any cash dividends on our capital stock and we do not currently anticipate declaring or paying cash dividends
on our capital stock in the foreseeable future. We currently intend to retain all of our future earnings, if any, to finance the operation
and expansion of our business. Any future determination relating to our dividend policy will be made at the discretion of our Board and
will depend on a number of factors, including future earnings, capital requirements, financial conditions, future prospects, contractual
restrictions and covenants, applicable law and other factors that our Board may deem relevant. If we do not pay dividends, a return on
your investment will occur only if the market price of our Common Stock appreciates.
Securities
authorized for issuance under equity compensation plans
On
August 26, 2021, our Board approved the 2021 Equity Incentive Plan (“2021 Plan”). On October 8, 2021, a majority of the voting
power of our capital stock approved the 2021 Plan. The 2021 Plan is administered by our Board or such committee appointed by the Board.
The 2021 Plan provides for the grant of incentive stock options, nonstatutory stock options, restricted stock, performance units, performance
shares, restricted stock units, and other stock-based awards to our employees, directors, and consultants. The purpose of the 2021 Plan
is to attract and retain the best available personnel for positions of substantial responsibility, to provide additional incentive to
our employees, directors and consultants, and to promote the success of the Company’s business. Under the terms of the 2021 Plan,
the Company initially reserved 134,630 shares of Common Stock, subject to an automatic increase on the first day of each calendar year
such that the number of shares available for issuance under the 2021 Plan will be 10% of the outstanding shares of Common Stock of the
company. The 2021 Plan further authorizes the administrator to amend the exercise price and terms of certain awards thereunder. As of
January 1, 2023, the number of shares authorized under the 2021 Plan increased to 144,818 shares of Common Stock. As of January 9,
2023, the Company has issued 2,500 shares of restricted Common Stock and options to purchase 18,641 shares of Common Stock.
Securities
Authorized for Issuance under Equity Compensation Plans
The
following table sets forth securities authorized for issuance under any equity compensation plans approved by our shareholders as well
as any equity compensation plans not approved by our stockholders as of January 9, 2023.
| Plan
category |
|
|
Number
of securities to
be
issued
upon
exercise
of outstanding options, warrants
and
rights(a) |
|
|
|
Weighted
average
exercise
price
of
outstanding
options, warrants and rights ($) |
|
|
|
Number
of securities remaining available for future
issuance
under
equity compensation plans
(excluding
securities reflected in column (a) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Plans
approved by our stockholders: |
|
|
— |
|
|
|
— |
|
|
|
— |
|
| 2021
Equity Incentive Plan (1) |
|
|
21,141 |
|
|
|
20.70 |
|
|
|
123,677 |
|
| Plans
not approved by stockholders |
|
|
|
|
|
|
|
|
|
|
|
|
| |
(1) |
The
2021 Equity Incentive Plan was adopted on August 26, 2021, by the Board and approved by our stockholders on October 8, 2021. On January
1 of each year, the number of shares available for issuance under the 2021 Equity Incentive Plan will increase, if necessary, to
be equal to 10% of the outstanding shares of Common Stock of the Company. We initially reserved 134,630 shares of Common Stock under
the 2021 Equity Incentive Plan. Pursuant to the automatic increase, as of January 1, 2023, there were 144,818 shares of Common Stock
authorized under the Plan. As of January 9, 2023, we have issued awards or grants under the plan in the aggregate of 21,141
awards underlying shares. |
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
We
have not had a change in or disagreement with our accountants within twenty four (24) months prior to the date of our most recent financial
statements or in any period subsequent to such date.
OUR
MANAGEMENT
Directors,
Executive Officers and Significant Employees
The
names of our directors and executive officers and their ages, positions, and biographies as of the date of this Prospectus are
set forth below. Our executive officers are appointed by, and serve at the discretion of the Board. There are no family relationships
among any of our directors or executive officers. For a description of the employment agreements and other ancillary agreements entered
into between our officers and directors and the Company, please refer to the section entitled Executive Compensation below.
Executive
Officers and Directors
| Name |
|
Age |
|
Positions |
|
Officer
/ Director
Since |
| I
Richard Garr |
|
68 |
|
CEO
(Principal Executive Officer, CFO (Principal Accounting Officer) and General Counsel |
|
2020 |
| Paul
Michaels |
|
56 |
|
President,
Chairman of the Board of Directors |
|
2020 |
| Michael Fish |
|
64 |
|
Director |
|
2021 |
| Barry
A. Ginsberg, O.D. |
|
65 |
|
Chief
Strategy Officer, Director |
|
2020 |
| Cary Sucoff * |
|
70 |
|
Director |
|
2022 |
| Lawrence Zaslow + |
|
60 |
|
Director |
|
2022 |
* Mr. Sucoff was appointed to the Board of Directors
on May 16, 2022.
+ Mr. Zaslow was appointed to the Board of Directors
on June 16, 2022
I
Richard Garr, joined as our chief executive officer and general counsel in 2021. In 2021 he was further appointed to serve as chief
financial officer. Mr. Garr has over 24 years of experience in the biotechnology industry. For the last five (5) years, he has
served as the managing partner of Access Hope, a CRO focused on expanded access clinical programs. Prior to that, Mr. Garr served
as chief executive officer, general counsel, and as a member of the Board of Directors for Neuralstem, Inc. a publicly traded biotechnology
company (NASDAQ: formerly CUR – now PALI). Mr. Garr also previously served as the chief financial and principal accounting officer
for Neuralstem as well. Mr. Garr is a graduate of Drew University (1976) and the Columbus School of Law, The Catholic University of America
(1979).
Paul
M. Michaels, serves as the Company’s president and chairman of the Board of Directors since September 1, 2020. For
the past five (5) years, Mr. Michaels has been an active investor in small cap and private companies. Prior to that, Mr. Michaels
cofounded Nobelpharma, Ltd. Japan, an affiliate of Inabata & Co. Ltd. That is now one of Japan’s orphan drug companies. Mr.
Michaels has provided financial leadership and business development to biotechnology companies for more than 20 years, including structuring
major pharma transactions. Mr. Michaels attended Tulane University. In evaluating Mr. Michael’s specific experience, qualifications,
attributes, and skills in connection with his appointment to the Board, the Board took into account his experience in the biotechnology
industry, including his financial and capital markets knowledge
Michael
Fish, is a licensed CPA and founder of a certified public accounting firm in Florida,
He has been the principal of such accounting firm for the previous 30 years. He has
expertise in all areas of accounting, finance, and taxes regarding corporate entities in
various industries. Mr. Fish earned his bachelor of arts degree in accounting from Florida
Atlantic University. In evaluating Mr. Fish’s specific experience, qualifications,
attributes, and skills in connection with his appointment to the Board, the Board took into
account his experience in financial matters, accounting, taxes, and capital markets.
Barry
A. Ginsberg, serves as Chief Strategy Officer and as a member of the Board of Directors of the Company since September
1, 2020. For the past five (5) years, Dr. Ginsberg has been an active investor in small cap and private companies. For more than 10 years,
Dr. Ginsberg has consulted with healthcare companies to develop global strategies and operating models in the health and wellness
industries. Dr. Ginsberg is a Board-Certified Optometric Physician who has practiced in Florida since 1983. Dr. Ginsberg earned a bachelor’s
degree in Chemistry with a minor in economics from Yeshiva University and bachelor’s and doctorate degree from Pennsylvania College
of Optometry. He also attended the MBA program at LaSalle College in Philadelphia. In evaluating Dr. Ginsberg’s specific experience,
qualifications, attributes, and skills in connection with his appointment to the Board, the Board took into account his wide knowledge
of pharmaceuticals, the medical field, and development of healthcare companies.
Cary
Sucoff, has more than 40 years of legal and
securities industry experience. Since 2011, Mr. Sucoff has owned and operated Equity Source Partners LLC, an advisory and consulting
firm. He has participated in the financing of hundreds of public and private healthcare companies. Since 2010, Mr. Sucoff has served
on the board of directors of Contrafect Corp. (Nasdaq: CFRX) (audit, nom/gov and pricing committees) and since 2020 he has served on
the board of IMAC Holdings, Inc. (Nasdaq: IMAC) (audit, compensation and nom/gov committees). Additionally, Mr. Sucoff currently serves
on the boards of First Wave Technologies, Inc. (since 2016), and Galimedix Therapeutics (since 2018). He previously served as a director
of Legacy Education Alliance, Inc. (OTC: LEAI) from 2015 to 2021. Mr. Sucoff, a former New York City prosecutor, is the past President
of New England Law/Boston and has been a member of the Board of Trustees for over 30 years. He has been Chairman of the Endowment Committee
for over ten years. Mr. Sucoff received a B.A. from SUNY Binghamton in 1974 and a J.D. from New England School of Law in 1977, where
he was the Managing Editor of the Law Review and graduated magna cum laude. He has been a member of the Bar of the State of New York
since 1978. We believe that Mr. Sucoff’s broad financial and legal experience qualifies him to serve as a member of our board of
directors.
Lawrence
Zaslow, has over 30 years experience in the biotechnology industry. Between 2014 through 2020, he served as President, Director,
Treasurer, and Secretary of BioTheryX, Inc., a private biotechnology company, which he cofounded. In 2020, Mr. Zaslow transitioned to
a senior advisor of the company until 2021. While employed by BioTheryX, Mr. Zaslow was responsible for strategic and operational planning,
capital raising, finance and budgeting, and corporate and business development. Prior to working for BioTheryX, Mr. Zaslow was a founding
member and managing director of Amphion PLC, a company focused on the financing and managing of life science and technology companies.
Mr. Zaslow holds a B.A. in economics from Brandeis University and an MBA in finance from Columbia Business School. We believe
that Mr. Zaslow’s experience in financing and managing biotechnology and life science companies qualifies him to serve as a member
of our board of directors.
Family
Relationships
There
are no family relationships between any director, executive officer, or person nominated or chosen by the registrant to become a director
or executive officer.
Involvement
in Certain Legal Proceedings
None
of our management or directors are currently subject to any legal proceedings.
CORPORATE
GOVERNANCE
Independent
Directors
For purposes of determining independence, the Company
has adopted the definition of independence as contained in Section 803(A) of the NYSE American LLC Company Guide. Pursuant
to the definition, the Company has determined that as of the date hereof, that Messrs. Sucoff and Zaslow qualify as independent. Under
the NYSE American LLC Company Guide, we are required, as a Smaller Reporting Company, to have at least 50% of our directors
be independent. Currently, three of our five directors are not independent. Notwithstanding the foregoing, pursuant to Section
809 of the NYSE American LLC Company Guide, we will have a one (1) year grace period to comply with the foregoing independent
director requirements.
Committees
The
Board of Directors has established three standing committees: (1) an Audit Committee, (2) a Governance and Nominating Committee, and
(3) a Compensation Committee. Each of the committees operates under a written charter adopted by the Board of Directors. A copy of each
respective committee’s charter can be viewed as Exhibits 99.01, 99.02, and 99.03 to this Registration Statement. On August 6,
2022, the Board reconstituted the Committees and adopted new Committee Charters in compliance with NYSE American rules.
The
table below identifies the Board’s standing committees and committee membership as of January 9, 2023:
| Director | |
| Independent | | |
Audit
Committee | |
Corporate
Governance
and
Nominating
Committee | |
Compensation
Committee |
| Michael Fish | |
| No | | |
No | |
No | |
No |
| Dr. Barry Ginsberg | |
| No | | |
No | |
No | |
No |
| Paul Michaels | |
| No | | |
No | |
No | |
No |
| Cary Sucoff | |
| Yes | | |
Yes (1) | |
Yes | |
Yes |
| Lawrence Zaslow | |
| Yes | | |
Yes | |
Yes (1) | |
Yes (1) |
| (1) |
Denotes
Chairperson of the applicable committee. |
Only
Cary Sucoff and Lawrence Zaslow are considered independent under the NYSE American LLC Company Guide pursuant to the Board’s
determination. The NYSE American LLC Company Guide requires:
| |
(1) |
A
Smaller Reporting Company to maintain an audit committee of at least two members, composed solely of independent directors who also
meet the requirements of Rule 10A-3 under the Securities Exchange Act of 1934, as amended. Both members: |
| |
a. |
Should
satisfy the independence standards specified
in Section 803(A) of the NYSE American LLC Company Guide; |
| |
|
|
| |
b. |
Must
not have participated in the preparation of the financial statements of the issuer or any current subsidiary of the issuer at any
time during the past three years; |
| |
|
|
| |
c. |
Should
be able to read and understand fundamental financial
statements, including a company’s balance sheet, income statement, and cash flow statement. Additionally, each issuer must
certify that it has, and will continue to have, at least one member of the audit committee who is financially sophisticated, in that
or she has past employment experience in finance or accounting, requisite professional certification in accounting, or any other
comparable experience or background which results in the individual’s financial sophistication, including but not limited to
being or having been a chief executive officer, chief financial officer, other senior officer with financial oversight responsibilities.
A director who qualifies as an audit committee financial expert under Item 407(d)(5)(ii) and (iii) of Regulation S-K or Item 3 of
Form N-CSR (in the case of a registered management investment company) is presumed to qualify as financially sophisticated; |
| |
(2) |
A
Compensation Committee (composed of independent directors or simply a majority of the independent directors of its Board can serve
in such capacity) that: |
| |
a. |
In
addition to satisfying the independence requirements of Section 803(A) of the NYSE American LLC Company Guide, the Board affirmatively
determines that all of the members of the Compensation Committee are independent. |
| |
(3) |
A
Nominating Committee responsible for Board nominations that is either a committee composed solely of independent directors, or the
function can be performed by a majority of the independent directors. Section 804 of the NYSE American LLC Company Guide
further require: |
| |
a. |
That
each listed company adopt a formal written charter or board resolutions, as applicable, addressing the nominations process and such
related matters as may be required under federal securities laws. |
The Board has determined that pursuant to Section
809 of the NYSE American LLC Company Guide, the Company will meet the required 50% independent members of the Board within
one year of listing. All of the Company’s committees comply with the NYSE American independence requirements.
Audit
Committee
We
have a designated an audit committee in accordance with section 3(a)(58)(A) of the Securities Exchange Act of 1934, as amended. The Audit
Committee assists the board in fulfilling its oversight responsibility relating to:
| |
● |
the
integrity of our financial statements; |
| |
|
|
| |
● |
our
compliance with legal and regulatory requirements; and |
| |
|
|
| |
● |
the
qualifications and independence of our independent registered public accountants. |
The
Audit Committee has the ultimate authority to select, evaluate and, where appropriate, replace the independent auditor, approve all audit
engagement fees and terms, and engage outside advisors, including its own counsel, as it deems necessary to carry out its duties. The
Audit Committee is also responsible for performing other related responsibilities set forth in its charter.
Pursuant
to NYSE American LLC Company Guide, as a smaller reporting company, our Audit Committee must be comprised of two (2)
independent, financially sophisticated, members. The Audit Committee currently consists of Cary Sucoff (chairperson), and
Lawrence Zaslow. Cary Sucoff and Lawrence Zaslow have been determined to be independent and Cary Sucoff has been determined to be financially
sophisticated by NYSE American Company Guide.
The
Board has determined that Cary Sucoff qualifies as an “audit committee financial expert” within the meaning of SEC rules.
An audit committee financial expert is a person who can demonstrate the following attributes: (1) an understanding of generally accepted
accounting principles and financial statements; (2) the ability to assess the general application of such principles in connection with
the accounting for estimates, accruals and reserves; (3) experience preparing, auditing, analyzing or evaluating financial statements
that present a breadth and level of complexity of accounting issues that are generally comparable to the breadth and complexity of issues
that can reasonably be expected to be raised by the Company’s financial statements, or experience actively supervising one or more
persons engaged in such activities; (4) an understanding of internal controls and procedures for financial reporting; and (5) an understanding
of audit committee functions. Mr. Sucoff and Mr. Zaslow qualify as independent as such term is defined in the NYSE American LLC Company
Guide.
A
copy of the Audit Committee Charter is contained in Exhibit 99.01 to this Registration Statement.
Compensation
Committee
The
Compensation Committee assists the Board in:
| |
● |
Recommending,
in executive session at which our chief executive officer is not present, the compensation and awards / bonuses for our CEO or president,
if such person is acting as the CEO, as well as other executive officers; |
| |
|
|
| |
● |
discharging
its responsibilities for approving and evaluating our officer compensation plans, policies and programs; |
| |
● |
reviewing
and recommending to the Board, compensation to be provided to our employees and directors; and |
| |
|
|
| |
● |
administering
our equity compensation plan(s). |
The
Compensation Committee is charged with ensuring that our compensation programs are competitive, designed to attract and retain highly
qualified directors, officers and employees, encourage high performance, promote accountability and assure that employee interests are
aligned with the interests of our stockholders. The Compensation Committee is composed of two (2) directors, Lawrence Zaslow (chairperson)
and Cary Sucoff. Mr. Sucoff and Mr. Zaslow qualify as independent.
A
copy of the Compensation Committee Charter is contained in Exhibit 99.02 to this Registration Statement.
Corporate
Governance and Nominating Committee
The
Corporate Governance and Nominating Committee:
| |
● |
assists
the Board in selecting nominees for election to the Board; |
| |
|
|
| |
● |
monitor
the composition of the Board; |
| |
|
|
| |
● |
develops
and recommends to the Board, and annually reviews, a set of effective corporate governance policies and procedures applicable to
our company; and |
| |
|
|
| |
● |
regularly
review the overall corporate governance of the Company and recommends improvements to the Board as necessary. |
The
purpose of the Corporate Governance and Nominating Committee is to assess the performance of the Board and to make recommendations to
the Board from time to time, or whenever it shall be called upon to do so, regarding nominees for the Board and to ensure our compliance
with appropriate corporate governance policies and procedures. The Corporate Governance and Nominating Committee is composed of two (2)
directors, Cary Sucoff and Lawrence Zaslow (chairperson). Mr. Sucoff and Mr. Zaslow qualify as independent within the meaning of NYSE
American LLC Company Guide.
A
copy of the Corporate Governance and Nominating Committee Charter is contained in Exhibit 99.03 to this Registration Statement.
Scientific and Clinical Advisory Board
The Company has a Scientific and Clinical Advisory
Board (“SAB”) that consists of (i) Michael Grace PhD, (ii) Ronald Bordens, PhD, (iii) Dr. Barry Ginsberg, (iv) Dr. Kapil
Bharti, (v) Dr. Dimiter Dimitrov; and (vi) Dr. Nicholas Boulis. Our SAB is not subject to a charter or any specific rules or procedures
governing the SAB. We have compensated members of our SAB through ad hoc grants of Common Stock and Series C Preferred Stock in the past.
The Company plans on adopting a formal policy for remuneration of our SAB in the future. The main role of our SAB is to advise our Board
and management regarding scientific and intellectual property matters related to the Company’s assets, anticipated research, and
product candidates.
Section
16(a) Beneficial Ownership Reporting Compliance
N/A
Stockholder
Recommendation of Board Nominees
We
currently do not have a formal policy on the submission of recommendations for candidates to the Board from stockholders. While the Board
has not adopted a formal diversity policy or specific standards with regard to the selection of director nominees, due to the nature
of our business, the Board believes it is important to consider diversity of race, ethnicity, gender, age, education, cultural background,
and professional experiences in evaluating board candidates. Additionally, although the Board has not formally established any specific,
minimum qualifications that must be met by each candidate for the Board or specific qualities or skills that are necessary for one or
more of the members of the Board to possess, when considering a potential non-incumbent candidate, the Board will factor into its determination
the following qualities of a candidate: educational background, diversity of professional experience, including whether the person is
a current or former chief executive officer or chief financial officer of a public company or the head of a division of a large international
organization, knowledge of our business, integrity, professional reputation, independence, and ability to represent the best interests
of our stockholders.
Code
of Ethics
We
are committed to maintaining the highest standards of honest and ethical conduct in running our business efficiently, serving our stockholders
interests and maintaining our integrity in the marketplace. To further this commitment, we have adopted our Code of Ethics and Business
Conduct, which applies to all our directors, officers and employees. A copy of our Code of Ethics and Business Conduct is attached to
this Registration Statement as Exhibit 14.01. If you would like to receive a copy of our Code of Ethics and Business Conduct, we will
provide you a copy free of charge. Please see the section of the Registration Statement entitled “Where to Find More Information”
for directions on how to request such information.
Limitation
on Liability and Indemnification of Directors and Officers
Our
directors and officers are indemnified as provided by the FBCA and our Bylaws. Please
see the section entitled “Indemnification of Directors and Officers” beginning on page II-1 hereof.
EXECUTIVE
COMPENSATION
Summary
Compensation Table
The following table provides disclosure concerning
all compensation paid for services to us in all capacities for our fiscal years ended December 31, 2022 and 2021 provided
by (i) each person serving as our principal executive officer, or PEO, or acting in a similar capacity during our fiscal year ended December
31, 2021 (ii) our most highly compensated executive officers other than our PEO who were serving as executive officers on December
31, 2022 and whose total compensation exceeded $100,000 (collectively with the PEO referred to as the “named executive officers”
in this Executive Compensation section); and (iii) our Principal Financial Officer.
Name
and
principal
position |
|
Year |
|
|
Salary
($) |
|
|
Bonus
($) |
|
|
Stock
Awards
($) |
|
|
Option
Awards ($) |
|
|
Non-equity
incentive plan compensation ($) |
|
|
Non-qualified
deferred
compensation
earnings
($) |
|
|
All
other compensation ($) |
|
|
Total
($) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Paul
Michaels |
|
|
2022 |
|
|
|
100,000 |
(1) |
|
|
10,000 |
|
|
|
51,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
225,393 |
(1)
|
|
|
387,143 |
|
| President |
|
|
2021 |
|
|
|
150,000 |
(4) |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,888,660 |
(4) |
|
|
3,038,660 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| I
Richard Garr |
|
|
2022 |
|
|
|
157,500 |
(2) |
|
|
10,000 |
|
|
|
|
|
|
|
51,750 |
|
|
|
|
|
|
|
|
|
|
|
287,893 |
(2)
|
|
|
507,143 |
|
| CEO,
CFO, General Counsel |
|
|
2021 |
|
|
|
170,000 |
(5) |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,896,411 |
(5) |
|
|
3,066,411 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Barry
Ginsberg |
|
|
2022 |
|
|
|
100,000 |
(3)
|
|
|
10,000 |
|
|
|
|
|
|
|
51,750 |
|
|
|
|
|
|
|
|
|
|
|
225,393 |
(3)
|
|
|
387,143 |
|
| Chief
Strategy Officer |
|
|
2021 |
|
|
|
150,000 |
(6) |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,801,411 |
(6) |
|
|
2,951,411 |
|
| |
(1)
|
Includes
(i) $100,000 of cash compensation paid as a W-2 employee, (ii) $200,000 of deferred salary,
(iii) $18,000 in Company paid medical benefits (including $12,000 deferred) and (iv)
$7,393 in deemed dividend for additional common shares value to be received upon conversion
of the Series C Preferred stock to common stock.
|
| |
(2)
|
Includes
(i) $157,500 of cash compensation paid as a W-2 employee, (ii) $262,500 of deferred salary,
(iii) $18,000 in Company paid medical benefits (including $12,000 deferred) and (iv)
$7,393 in deemed dividend for additional common shares value to be received upon conversion
of the Series C Preferred stock to common stock.
|
| |
(3) |
Includes
(i) $100,000 of cash compensation paid as a W-2 employee, (ii) $200,000 of deferred salary,
(iii) $18,000 in Company paid medical benefits (including $12,000 deferred) and (iv)
$7,393 in deemed dividend for additional common shares value to be received upon conversion
of the Series C Preferred stock to common stock.
|
| |
(4) |
Includes
(i) $100,000 of cash compensation paid as an independent contractor, (ii) $150,000 of cash compensation paid as a W-2 employee, (iii)
$6,000 in Company paid medical benefits and (iv) $2,695,411 in deemed dividend for additional common shares value to be received
upon conversion of the Series C Preferred stock to common stock. |
| |
(5) |
Includes
(i) $195,000 of cash compensation paid as an independent contractor, (ii) $170,000 of cash compensation paid as a W-2 employee, (iii)
$6,000 in Company paid medical benefits and (iv) $2,695,411 in deemed dividend for additional common shares value to be received
upon conversion of the Series C Preferred stock to common stock. |
| |
(6) |
Includes
(i) $100,000 of cash compensation paid as an independent contractor, (ii) $150,000 of cash compensation paid as a W-2 employee, (iii)
$6,000 in Company paid medical benefits and (iv) $2,695,411 in deemed dividend for additional common shares value to be received
upon conversion of the Series C Preferred stock to common stock. |
Employment
Agreement of Paul Michaels
On
October 1, 2020, the Company entered into an employment agreement with Paul Michaels to serve as President for a term of three (3) years
beginning on September 1, 2020, and expiring on August 31, 2023 (“Michaels Employment Agreement”). Pursuant to the
Michaels Employment Agreement, Mr. Michaels receives an annual salary of $240,000 per annum, which was increased by the Board to $300,000
per annum, effective September 1, 2021. The Michaels Employment Agreement states that the Company will accrue his outstanding salary
until such time as the Company receives adequate funding. Mr. Michaels received all compensation as an independent contractor until June
15, 2021, when Mr. Michaels began receiving his salary as an employee. Effective September 30, 2021, the Board agreed to provide an additional
$1,500 per month healthcare / transportation stipend to all employees, including Mr. Michaels.
The
Company may terminate Mr. Michaels’ employment at any time for “Cause” as such term is defined in the Michaels Employment
Agreement without any further compensation due to Mr. Michaels. In the event that the Company terminates Mr. Michaels’ employment
without “Cause”, the Company will pay within 15 days of such termination, an amount equal to one year’ salary at the
current base salary, plus continued medical coverage, if any, for the remainder of the term of the Michaels Employment Agreement. The
Michaels Employment Agreement further stipulates that Mr. Michaels will not directly or indirectly solicit any customers of the Company.
There
are no family relationships between Mr. Michaels and any of the directors or officers of the Company.
The
following table shows the required severance payments to be paid to Mr. Michaels upon a termination without “Cause” as of
December 31, 2022:
| Officer | |
Severance(1) | | |
Medical
Payments / Premiums (2) | | |
Total | |
| Paul
Michaels | |
$ | 300,000 | | |
$ | 12,000 | | |
$ | 312,000 | |
| |
(1) |
Effective Base Salary of $300,000 as of December 31, 2022. |
| |
(2) |
Represents
continued medical coverage cost for remainder of Term (8 months as of 12/31/2022) based on the $1,500 per month healthcare
stipend effective September 30, 2021. |
Employment
Agreement of I Richard Garr
On
October 1, 2020, the Company entered into an employment agreement with I Richard Garr to serve as CEO and General Counsel for a term
of three (3) years beginning on September 1, 2020 and expiring on August 31, 2023 (“Garr Employment Agreement”). On August
26, 2021, the Board additionally appointed Mr. Garr to serve as CFO of the Company. Pursuant to the Garr Employment Agreement, Mr. Garr
receives an annual salary of $360,000 per annum, which was increased by the Board to $420,000 per annum, effective September 1, 2021.
The Garr Employment Agreement states that the Company will accrue his outstanding salary until such time as the Company receives adequate
funding. Mr. Garr received all compensation as an independent contractor until August 1, 2021, when Mr. Garr began receiving his salary
as an employee. Effective September 30, 2021, the Board agreed to provide an additional $1,500 per month healthcare / transportation
stipend to all employees, including Mr. Garr.
The
Company may terminate Mr. Garr’s employment at any time for “Cause” as such term is defined in the Garr Employment
Agreement without any further compensation due to Mr. Garr. In the event that the Company terminates Mr. Garr’s employment without
“Cause”, the Company will pay within 15 days of such termination, an amount equal to one year’ salary at the current
base salary, plus continued medical coverage, if any, for the remainder of the term of the Garr Employment Agreement. The Garr Employment
Agreement further stipulates that Mr. Garr will not directly or indirectly solicit any customers of the Company.
There
are no family relationships between Mr. Garr and any of the directors or officers of the Company.
The
following table shows the required severance payments to be paid to Mr. Garr upon a termination without “Cause” as of December
31, 2022:
| Officer | |
Severance(1) | | |
Medical
Payments / Premiums (2) | | |
Total | |
| I
Richard Garr | |
$ | 420,000 | | |
$ | 12,000 | | |
$ | 432,000 | |
| |
(1) |
Effective Base Salary of $420,000 as of December 31, 2022. |
| |
(2) |
Represents
continued medical coverage cost for remainder of Term (8 months as of 12/31/2022) based on the $1,500 per month healthcare
stipend effective September 30, 2021. |
Employment
Agreement of Barry Ginsberg
On
October 1, 2020, the Company entered into an employment agreement with Dr. Barry Ginsberg to serve as Chief Strategy Officer for a term
of three (3) years beginning on September 1, 2020, and expiring on August 31, 2023 (“Ginsberg Employment Agreement”).
Pursuant to the Ginsberg Employment Agreement, Dr. Ginsberg receives an annual salary of $240,000 per annum, which was increased by the
Board to $300,000 per annum, effective September 1, 2021. The Ginsberg Employment Agreement states that the Company will accrue his outstanding
salary until such time as the Company receives adequate funding. Dr. Ginsberg received all compensation as an independent contractor
until June 15, 2021, when Dr. Ginsberg began receiving his salary as an employee. Effective September 30, 2021, the Board agreed to provide
an additional $1,500 per month healthcare / transportation stipend to all employees, including Dr. Ginsberg.
The
Company may terminate Mr. Ginsberg’s employment at any time for “Cause” as such term is defined in the Ginsberg Employment
Agreement without any further compensation due to Dr. Ginsberg. In the event that the Company terminates Dr. Ginsberg’s employment
without “Cause”, the Company will pay within 15 days of such termination, an amount equal to one year’ salary at the
current base salary, plus continued medical coverage, if any, for the remainder of the term of the Ginsberg Employment Agreement. The
Ginsberg Employment Agreement further stipulates that Dr. Ginsberg will not directly or indirectly solicit any customers of the Company.
There
are no family relationships between Dr. Ginsberg and any of the directors or officers of the Company.
The
following table shows the required severance payments to be paid to Dr. Ginsberg upon a termination without “Cause” as of
December 31, 2022:
| Officer | |
Severance(1) | | |
Medical
Payments / Premiums (2) | | |
Total | |
| Dr.
Barry Ginsberg | |
$ | 300,000 | | |
$ | 12,000 | | |
$ | 312,000 | |
| |
(1) |
Effective Base Salary of $300,000 as of December 31, 2022. |
| |
(2) |
Represents
continued medical coverage cost for remainder of Term (8 months as of 12/31/2022) based on the $1,500 per month healthcare
stipend effective September 30, 2021. |
Outstanding
Equity Awards Value at Fiscal Year-End
Please
see Stock Awards for Executive Compensation Table above.
Our
Equity Compensation Plans
On August 26, 2021, our Board approved the 2021 Equity
Incentive Plan (“2021 Plan”). On October 8, 2021, a majority of the voting power of our capital stock approved the 2021 Plan.
The 2021 Plan is administered by our Board or such committee appointed by the Board. The 2021 Plan provides for the grant of incentive
stock options, nonstatutory stock options, restricted stock, performance units, performance shares, restricted stock units, and other
stock-based awards to our employees, directors, and consultants. The purpose of the 2021 Plan is to attract and retain the best available
personnel for positions of substantial responsibility, to provide additional incentive to our employees, directors and consultants, and
to promote the success of the Company’s business. Under the terms of the 2021 Plan, the Company initially reserved 134,630
shares of Common Stock, subject to an automatic increase on the first day of each calendar year such that the number of shares available
for issuance under the 2021 Plan will be 10% of the outstanding shares of Common Stock of the company. As of January 1, 2022, there were
142,662 shares reserved for issuance under the 2021 Plan, none of which were outstanding. The 2021 Plan further authorizes the
administrator to amend the exercise price and terms of certain awards thereunder. As of August 24, 2022, the Company has issued options
to purchase 18,641 shares of Common Stock and 2,500 shares of restricted Common Stock under our 2021 Equity Incentive Plan.
Securities
Authorized for Issuance under Equity Compensation Plans
The
following table sets forth securities authorized for issuance under any equity compensation plans approved by our shareholders as well
as any equity compensation plans not approved by our stockholders as of January 9, 2023.
| Plan
category |
|
Number of securities to
be issued
upon
exercise of outstanding options, warrants
and
rights(a)
|
|
|
Weighted average
exercise price
of
outstanding options, warrants and rights ($)
|
|
|
Number of securities remaining available for future
issuance
under equity compensation plans
(excluding securities reflected in column (a)
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Plans
approved by our stockholders: |
|
|
— |
|
|
|
— |
|
|
|
— |
|
| 2021
Equity Incentive Plan (1) |
|
|
21,141 |
|
|
$ |
20.70 |
|
|
|
123,677 |
|
| Plans
not approved by stockholders |
|
|
|
|
|
|
|
|
|
|
|
|
| |
(1) |
The
2021 Equity Incentive Plan was adopted on August 26, 2021, by the Board and approved by our stockholders on October 8, 2021. On January
1 of each year, the number of shares available for issuance under the 2021 Equity Incentive Plan will increase, if necessary, to
be equal to 10% of the outstanding shares of common stock of the Company. We initially reserved 134,630 shares of Common Stock under
the 2021 Equity Incentive Plan. Pursuant to the automatic increase, as of January 1, 2023, there were 144,818 shares of Common Stock
authorized under the Plan. As of January 9, 2023, we have issued awards or grants under the plan in the aggregate of 21,141. |
Director
Compensation
Current
Board Compensation Policy
The
Board does not have a formal compensation policy regarding its non-employee directors. The Board has previously awarded its non-employee
directors with ad hoc equity based awards upon joining the Board. The Board anticipates continuing to issue equity grants for its non-employee
directors until such time that it implements a formal compensation policy for its non-employee Board members.
The
following table provides information concerning the compensation paid to our non-executive directors for their services as members of
our board of directors for the year ended December 31, 2022.
| Name | |
Fees
earned or
paid in
cash ($) | | |
Stock
awards ($) | | |
Option
awards ($) | | |
Non-equity
incentive plan compensation ($) | | |
Nonqualified
deferred compensation earnings ($) | | |
All
other compensation ($) | | |
Total
($) | |
| Michael
Fish (1) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
| Cary Sucoff (2) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
| Lawrence Zaslow (3) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
| |
(1) |
Mr. Fish resigned as a member of the Board of Directors effective September 1, 2021. On November 12, 2021, Mr. Fish was reappointed to the Board to fill the vacancy created by Mr. Drimer’s passing. |
| |
|
|
| |
(2) |
Mr. Sucoff was appointed to the Board effective May 16, 2022. |
| |
|
|
| |
(3) |
Mr. Zaslow was appointed to the Board effective June 16, 2022. |
PRINCIPAL
STOCKHOLDERS
Security
ownership of certain beneficial owners.
Beneficial
ownership for the purposes of the following table is determined in accordance with the rules and regulations of the SEC. These rules
generally provide that a person is the beneficial owner of securities if they have or share the power to vote or direct the voting thereof,
or to dispose or direct the disposition thereof or have the right to acquire such powers within 60 days. Accordingly, the following tables
do not include options or warrants to purchase our common stock that are not exercisable within the next 60 days.
COMMON
STOCK
| Name
and Address of Beneficial Owner (1) |
|
Shares |
|
|
Shares
Underlying Convertible Securities |
|
|
Total |
|
|
Percent
of Class (2) |
|
| Directors
and named executive officers |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Paul
Michaels (9) |
|
|
74,024 |
(3) |
|
|
13,000 |
(4) |
|
|
87,024 |
|
|
|
5.96 |
% |
| I
Richard Garr (9) |
|
|
36,375 |
|
|
|
6,213 |
(5) |
|
|
42,588 |
|
|
|
2.93 |
% |
| Barry
Ginsberg (9) |
|
|
179,190 |
(6) |
|
|
6,713 |
(7) |
|
|
185,903 |
|
|
|
12.78 |
% |
| Michael
Fish (8) |
|
|
1,250 |
|
|
|
- |
|
|
|
1,250 |
|
|
|
* |
|
| Cary
Sucoff (10) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
| Lawrence
Zaslow (11) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| All
directors and named executive officers as a group (6) individuals) |
|
|
290,839 |
|
|
|
25,926 |
|
|
|
316,765 |
|
|
|
21.56 |
% |
| * |
Represents
less than one percent. |
| |
|
| (1) |
Except
as otherwise indicated, the persons named in this table have sole voting and investment power with respect to all shares of common
stock shown as beneficially owned by them, subject to community property laws where applicable and to the information contained in
the footnotes to this table. Unless otherwise indicated, the address of the beneficial owner is c/o Curative Biotechnology, Inc.,
1825 NW Corporate Blvd., Suite 110, Boca Raton, FL 33431. |
| |
|
| (2) |
Pursuant
to Rules 13d-3 and 13d-5 of the Exchange Act, beneficial ownership includes any shares as to which a shareholder has sole or shared
voting power or investment power, and also any shares which the shareholder has the right to acquire within 60 days, including upon
exercise of common share purchase options or warrants. There are 1,448,177 shares of common stock issued and outstanding as of January
9, 2023. |
| |
|
| (3) |
Represents
Shares owned personally by Mr. Michaels and further includes 27,414 shares out of 54,829 shares owned by SunMed Advisors,
an entity that is owned 50% by Mr. Michaels. |
| (4) |
Represents (i) a warrant to purchase 12,500 shares of Common
Stock issued on June 11, 2021, having an exercise price of $80.00 per share and term of three years from issuance, (ii) a
warrant to purchase 500 shares of Common stock issued on December 3, 2020, having an exercise price of $20.00 per share
and a term of three (3) years. |
| |
|
| (5) |
Represents an option to purchase 6,213 shares of Common Stock
issued on January 14, 2022, having an exercise price of $20.68, and a term of five (5) years. |
| |
|
| (6) |
Represents shares owned personally by Dr. Ginsberg and further includes
27,414 shares out of 54,829 shares owned by SunMed Advisors, an entity that is owned 50% by Dr. Ginsberg |
| |
|
| (7) |
Represents (i) a warrant to purchase 500 shares of Common stock
issued on December 3, 2020, having an exercise price of $20.00 per share and a term of three (3) years and (ii) an option
to purchase 6,213 shares of Common Stock issued on January 14, 2022, having an exercise price of $20.68, and a term
of five (5) years. |
| |
|
| (8) |
Mr. Fish resigned from the Board of Directors effective September 1, 2021. Effective November 12, 2021, Mr. Fish was reappointed to the Board to fill the vacancy created by Mr. Drimer’s passing. |
| |
|
| (9) |
Does not include 6,000,000 shares of Series C Preferred Stock owned
by such person. All 6,000,000 shares of Series C Preferred Stock are convertible into approximately 122,496 shares of Common
Stock as of August 24, 2022. Such ownership on conversion is not reflected in the above “Totals” or “Percent of
Class” columns. 100% of the Series C Preferred Stock converts into 30% of the issued and outstanding Common Stock in the aggregate
on a post conversion basis. For a further description of the beneficial ownership of the Series C Preferred Stock, please see the
beneficial ownership table of “Series C Preferred Stock” below. |
| |
|
| (10) |
Mr. Sucoff joined the Board effective May 16, 2022. |
| |
|
| (11) |
Mr. Zaslow joined the Board effective June 16, 2022. |
SERIES
B PREFERRED STOCK
The
Company also has 227,000 shares of Series B Preferred Stock issued and outstanding. Each Share of Series B Preferred Stock converts
into Common Stock at a price per share of $3.00. The Series B Preferred Stock votes on an as converted to Common Stock basis or approximately
133.33 votes per share of Series B Preferred Stock. Except as otherwise indicated, the address of each of the shareholders listed below
is: c/o Curative Biotechnology, Inc., 1825 NW Corporate Blvd, Suite 110, Boca Raton, FL 33431.
| Name and Address of Beneficial Owner (1) | |
Shares | | |
Shares Underlying Convertible Securities | | |
Total | | |
Percent of
Class (2) | |
| 5% owners | |
| | | |
| | | |
| | | |
| | |
| Charma Larkin
| |
| 26,000 | | |
| - | | |
| 26,000 | | |
| 13.20 | % |
Navare,
Girish | |
| 35,000 | | |
| - | | |
| 35,000 | | |
| 17.77 | % |
| Turner, Glen | |
| 35,000 | | |
| - | | |
| 35,000 | | |
| 17.77 | % |
| Spiegel, Irnest | |
| 15,000 | | |
| - | | |
| 15,000 | | |
| 7.61 | % |
| Big Apple LLC (3) | |
| 45,000 | | |
| - | | |
| 45,000 | | |
| 22.84 | % |
| Red Tie Financial, Inc. (4) | |
| 10,000 | | |
| - | | |
| 10,000 | | |
| 5.08 | % |
| All 5% owners as a group (6 individuals) | |
| 166,000 | | |
| - | | |
| 166,000 | | |
| 84.26 | % |
| (1) |
Except
as otherwise indicated, the persons named in this table have sole voting and investment power with respect to all shares of Series
B Preferred Stock shown as beneficially owned by them, subject to community property laws where applicable and to the information
contained in the footnotes to this table. |
| |
|
| (2) |
Pursuant
to Rules 13d-3 and 13d-5 of the Exchange Act, beneficial ownership includes any shares as to which a shareholder has sole or shared
voting power or investment power, and also any shares which the shareholder has the right to acquire within 60 days, including upon
exercise of common share purchase options or warrants. There are 227,000 shares of Series B Preferred Stock issued and outstanding
as of January 9, 2023. |
| |
|
| (3) |
C/O
850 North West Federal Highway #411, Stuart, Florida 33494 |
| |
|
| (4) |
95 Wekaiva Spring Road #320, Longwood, Florida 32779 |
SERIES
C PREFERRED STOCK
The
Company also has 30,000,000 shares of Series C Preferred Stock issued and outstanding. The Series C Preferred Stock votes such that each
share of Common Stock upon conversion of a share of Series C Preferred Stock will have 10 votes. The Series C Preferred Stock in the
aggregate converts into 30% of the issued and outstanding shares of Common Stock on the date of conversion. All of the holders have
agreed to convert their shares of Series C Preferred stock into Common Stock immediately prior to the closing of the offering contemplated
by this Prospectus.
| Name
and Address of Beneficial Owner (1) | |
Shares | | |
Shares
Underlying Convertible Securities | | |
Total | | |
Percent
of Class (2) | |
| 5%
owners | |
| | | |
| | | |
| | | |
| | |
| Paul
Michaels | |
| 6,000,000 | | |
| - | | |
| 6,000,000 | | |
| 20.00 | % |
| Barry
Ginsberg | |
| 6,000,000 | | |
| - | | |
| 6,000,000 | | |
| 20.00 | % |
| Michael
Grace | |
| 6,000,000 | | |
| - | | |
| 6,000,000 | | |
| 20.00 | % |
| Ronald
Bordens | |
| 6,000,000 | | |
| - | | |
| 6,000,000 | | |
| 20.00 | % |
| I
Richard Garr | |
| 6,000,000 | | |
| - | | |
| 6,000,000 | | |
| 20.00 | % |
| All
5% owners as a group (5 individuals) | |
| 30,000,000 | | |
| - | | |
| 30,000,000 | | |
| 100 | % |
| (1) |
Except
as otherwise indicated, the persons named in this table have sole voting and investment power with respect to all shares of common
stock shown as beneficially owned by them, subject to community property laws where applicable and to the information contained in
the footnotes to this table. Unless otherwise indicated, the address of the beneficial owner is c/o Curative Biotechnology, Inc.,
1825 NW Corporate Blvd., Suite 110, Boca Raton, FL 33431. |
| |
|
| (2) |
Pursuant
to Rules 13d-3 and 13d-5 of the Exchange Act, beneficial ownership includes any shares as to which a shareholder has sole or shared
voting power or investment power, and also any shares which the shareholder has the right to acquire within 60 days, including upon
exercise of common share purchase options or warrants. There are 30,000,000 shares of Series C Preferred Stock issued and outstanding
as of January 9, 2023. |
| |
|
| (3) |
All
30,000,000 shares of Series C Preferred Stock of beneficial owner are convertible into 620,647 shares of Common Stock as of
October 20, 2022. The Series C Preferred Stock converts into 30% of the issued and outstanding Common Stock in the aggregate on a
post conversion basis. |
Change
of Control
None.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
Related
Party Transactions
Information
regarding disclosure of an employment relationship or transaction involving an executive officer and any related compensation solely
resulting from that employment relationship or transaction is incorporated by reference from the section of this Prospectus entitled
“Executive Compensation.”
Information
regarding disclosure of compensation to a director is incorporated by reference from the section of this Prospectus entitled “Director
Compensation.”
Summarized
below are certain transactions and business relationships between the Company and persons who are or were an executive officer, director
or holder of more than five percent of any class of our securities (at the time of the transaction) since January 1, 2020:
| |
● |
On
February 24, 2020, SunMed Advisors, Inc. purchased 54,829 shares of Series A Preferred Stock from former principals of the
Company in exchange for $60,000. SunMed Advisors is owned (i) 50% by Barry Ginsberg, our Chief Strategy Officer and director and
(ii) 50% by Paul Michaels, our president. On March 30, 2021, SunMed Advisors converted all of its Series A Preferred Stock into 54,829
shares of Common Stock. |
| |
|
|
| |
● |
On
May 18, 2020, the Board granted Richard Garr, our chief executive officer, 625 shares of restricted stock valued at $7,500. |
| |
|
|
| |
● |
On
November 8, 2020, the Board granted Michael Fish, a member of our Board, 250 shares of restricted stock valued at $3,000. Mr. Fish
resigned from the Board in August 2021. On November 12, 2021, Mr. Fish was reappointed to the Board to fill the vacancy created
by Mr. Drimer’s passing. |
| |
|
|
| |
● |
On
November 11, 2020, the Company issued 100,000,000 shares Series A Preferred Stock in exchange for services related to corporate restructuring
and in-licensing of technology to the Company to Paul Michaels and Barry Ginsberg, our president and Chief Strategy Officer, respectively.
Each of Dr. Ginsberg and Mr. Michaels received 50,000,000 shares of Series A Preferred Stock valued at $775,420 each. The Series
A Preferred Stock in the aggregate, including other outstanding shares of which there were 34,109,750 already outstanding, was convertible
at any time into 35% of the issued and outstanding Common Stock post conversion. On April 7, 2021, Mr. Michaels and Dr. Ginsberg
converted all of their outstanding shares of Series A Preferred Stock into 253,219 shares of Common Stock. |
| |
● |
On November 11, 2020, the Company issued an aggregate of 30,000,000
shares of Series C Preferred Stock to certain employee and service providers of the Company. The Series C Preferred Stock is collectively
convertible into such number of shares of Common Stock as will equal 30% of the issued and outstanding Common Stock post conversion.
The Series C Preferred Stock votes 10 votes for every 1 share of Common Stock that the Series C Stock is convertible into. Of the
30,000,000 shares of Series C Preferred Stock issued, 6,000,000 were issued to each of (i) Paul Michaels, our Chairman and President,
(ii) Barry Ginsberg, our Chief Strategy Officer and Director, and (iii) Richard Garr, our Chief Executive Officer, Chief Financial
Officer, and General Counsel, for services related to corporate restructuring and in-licensing of technology. Such 18,000,000 shares
of Series C Preferred Stock are valued at an aggregate of $2,735,437. Pursuant to the ownership of 18,000,000 shares of Series C
Preferred Stock, Richard Garr, Barry Ginsberg, and Paul Michaels collectively, have the right to exercise voting control with respect
to their Series C Preferred Stock only, of approximately 48.47% of the voting power of all capital stock of the Company as of January
9, 2023. |
| |
|
|
| |
● |
On December 3, 2020, the Company sold $40,000 of promissory notes to
Paul Michaels and Barry Ginsberg ($20,000 each), our president and Chief Strategy Officer. The Notes have an original issue discount
such that an aggregate of $50,000 is due under the Notes within six (6) months from issuance. The Company paid back $50,000 in satisfaction
of the Notes on June 3, 2021. Additionally, Mr. Michaels and Dr. Ginsberg were each issued warrants to purchase 500 shares
of Common Stock with an exercise price of $20.00 per share and a term of three (3) years. |
| |
|
|
| |
● |
On June 11, 2021, the Board granted Paul Michaels, our president and
a director, warrants to purchase 12,500 shares of Common Stock. The exercise price of the warrant is $80.00 per share,
and the warrant has a term of 3 years from issuance. The warrant grant was valued at $87,249. |
| |
|
|
| |
● |
On July 14, 2021, upon joining the Board, Marc Drimer was granted a
warrant to purchase 2,500 shares of Common Stock. The warrant has an exercise price of $49.60 per share, a term of 3 years
from issuance and vests in 4 equal quarterly installments beginning July 14, 2021 and ending on July 14, 2022. The warrant was valued
at $34,382. Pursuant to Mr. Drimer’s passing, 1,250 shares underlying warrants vested and the remaining 1,250 that were unvested
were cancelled. |
| |
|
|
| |
● |
On September 1, 2021, in conjunction with his initial resignation from
the Board, Michael Fish was granted 750 shares of Common Stock valued at $36,750. |
| |
|
|
| |
● |
On January 14, 2022, the Board granted 2,500 shares of common
stock valued at $51,750, to Paul Michaels and Options to purchase 6,213 shares of common stock at an exercise price of $20.70
to each of Barry Ginsberg and Richard Garr, with each such grant valued at $51,750. |
INDEMNIFICATION
OF DIRECTORS AND OFFICERS
Florida
law permits, under certain circumstances, the indemnification of any person with respect to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative, to which such person was or is a party or is threatened
to be made a party, by reason of his or her being an officer, director, employee or agent of the corporation or is or was serving at
the request of such corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or
other enterprise, against liability incurred in connection with such proceeding, including appeals thereof; provided, however, that the
officer, director, employee or agent acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed
to, the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe
his or her conduct was unlawful. The termination of any such third-party action by judgment, order, settlement, or conviction or upon
a plea of nolo contendere or its equivalent does not, of itself, create a presumption that the person (i) did not act in good faith and
in a manner which he or she reasonably believed to be in, or not opposed to, the best interests of the corporation or (ii) with respect
to any criminal action or proceeding, had reasonable cause to believe that his or her conduct was unlawful. In the case of proceedings
by or in the right of the corporation, Florida law permits indemnification of any person by reason of the fact that such person is or
was a director, officer, employee or agent of the corporation or is or was serving at the request of such corporation as a director,
officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against liability incurred
in connection with such proceeding, including appeals thereof; provided, however, that the officer, director, employee or agent acted
in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, the best interests of the corporation,
except that no indemnification is made where such person is adjudged liable, unless a court of competent jurisdiction determines that,
despite the adjudication of liability but in view of all circumstances of the case, such person is fairly and reasonably entitled to
indemnity for such expenses which such court shall deem proper.
To
the extent that such person is successful on the merits or otherwise in defending against any such proceeding, Florida law provides that
he or she shall be indemnified against expenses actually and reasonably incurred by him or her in connection therewith.
Also,
under Florida law, expenses incurred by an officer or director in defending a civil or criminal proceeding may be paid by the corporation
in advance of the final disposition of such proceeding upon receipt of an undertaking by or on behalf of such director or officer to
repay such amount if he or she is ultimately found not to be entitled to indemnification by the corporation pursuant to this section.
Expenses incurred by other employees and agents may be paid in advance upon such terms or conditions that the Board of Directors deems
appropriate.
Our
Bylaws provides that we shall indemnify our officers, directors, and employees, and agents unless specifically approved in writing by
the Board of Directors, to the fullest extent authorized by Section 607.0850 of the Florida Business Corporation Act, or the FBCA, as
it existed when the Bylaws were adopted or as it may hereafter be amended, but, in the case of any such amendment, only to the extent
that such amendment permits us to provide broader indemnification rights than were permitted prior to such amendment. Such indemnification
shall continue as to a person who has ceased to be a director, officer, employee, or agent; provided, however, that we shall indemnify
any such person seeking indemnity in connection with an action, suit, or proceeding (or part thereof) initiated by such person only if
such action, suit, or proceeding (or part thereof) was authorized by our Board of Directors.
The
Bylaws also provide that such rights of indemnification shall be a contract right and shall include the right to be paid by us for all
reasonable expenses incurred in defending any such proceeding in advance of final disposition; provided, however, that the payment of
such expenses incurred by a director or officer in his or her capacity as a director or officer in advance of the final disposition of
such proceeding shall be made only upon delivery to us of an undertaking, by or on behalf of such director or officer, to repay amounts
so advanced if it should be determined ultimately that such director or officer is not entitled to be indemnified under the Bylaws or
otherwise.
In
addition to the authority granted to us by Florida law to indemnify our directors, certain other provisions of the Florida Act have the
effect of further limiting the personal liability of our directors. Pursuant to Florida law, a director of a Florida corporation cannot
be held personally liable for monetary damages to the corporation or any other person for any act or failure to act regarding corporate
management or policy except in the case of certain qualifying breaches of the director’s duties.
Prior
to the completion of the offering, the Company anticipates entering into indemnification agreements with our officers and directors.
Insofar
as indemnification for liabilities arising under the Securities Act, as amended, may be permitted to our directors and officers, or to
persons controlling us, pursuant to our charter documents and Florida law, we have been informed that in the opinion of the Securities
and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933, as amended and is therefore
unenforceable.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers or persons controlling
the Company pursuant to the foregoing provisions, the Securities and Exchange Commission’s position is that such indemnification
is against public policy as expressed in the Securities Act of 1933 and is therefore unenforceable.
UNDERWRITING
Aegis
Capital Corp. (“Aegis) is acting as the sole underwriter of the offering. We have entered into an underwriting agreement dated
, 2022, with Aegis. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to the underwriter
named below and the underwriter named below have agreed to purchase, at the public offering price less the underwriting discounts and
commissions set forth on the cover page of this prospectus, the following number of shares of our common stock and Warrants:
| Underwriter |
|
Number
of Shares |
|
|
Number
Of Warrants |
|
| Aegis
Capital Corp. |
|
|
|
|
|
|
|
|
The
underwriter is committed to purchase all the shares of common stock and Warrants offered by us other than those covered by the
option to purchase additional shares described below, if they purchase any shares. The obligations of the underwriter may be terminated
upon the occurrence of certain events specified in the underwriting agreement. Furthermore, pursuant to the underwriting agreement, the
underwriter’s obligations are subject to customary conditions, representations and warranties contained in the underwriting agreement,
such as receipt by the underwriter of officers’ certificates and legal opinions.
We
have agreed to indemnify the underwriter against specified liabilities, including liabilities under the Securities Act of 1933, as amended,
and to contribute to payments the underwriter may be required to make in respect thereof.
The
underwriter is offering the common stock and Warrants, subject to prior sale, when, as and if issued to and accepted by them,
subject to approval of legal matters by their counsel and other conditions specified in the underwriting agreement. The underwriter reserves
the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.
The
underwriter proposes to offer the Common Stock and Warrants offered by us to the public at the public offering price set forth
on the cover of this prospectus. In addition, the underwriter may offer some of the common stock and/or Warrants to other securities
dealers at such price less a concession of $
per share or Warrant. After the initial offering, the public offering price and concession to dealers may be changed.
Discounts
and Commissions. The following table shows the public offering price, underwriting discount, non-accountable underwriter’s
expense allowance and proceeds, before expenses, to us. The information assumes either no exercise or full exercise by the underwriter
of its over-allotment option.
| |
|
|
|
|
|
|
|
Total |
|
| |
|
Per
Share |
|
|
Warrant |
|
|
Without
Over-
Allotment |
|
|
With
Over-
Allotment |
|
| Public
offering price |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
| Underwriting
discount (7.0%) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
| Non-accountable
expense allowance (1.0%) |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
| Proceeds,
before expenses, to us |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
We
have agreed to pay a non-accountable expense allowance to the underwriter equal to 1.0% of the gross proceeds we received in this offering.
In addition, we have also agreed to pay all expenses relating to the offering, including (a) all filing fees and expenses relating to
the registration of the shares to be sold in the offering (including shares sold upon exercise of the underwriter’ over-allotment
option) with the Commission; (b) all FINRA Public Offering filing fees; (c) all fees and expenses relating to the listing of the Company’s
equity or equity-linked securities on an Exchange; (d) all fees, expenses and disbursements relating to the registration or qualification
of the Securities under the “blue sky” securities laws of such states and other jurisdictions as the underwriter
may reasonably designate (including, without limitation, all filing and registration fees, and the reasonable fees and disbursements
of the Company’s “blue sky” counsel, which will be underwriter’s counsel) unless such filings are not required
in connection with the Company’s proposed Exchange listing; (e) all fees, expenses and disbursements relating to the registration,
qualification or exemption of the shares under the securities laws of such foreign jurisdictions as underwriter may reasonably designate;
(f) the costs of all mailing and printing of the offering documents; (g) transfer and/or stamp taxes, if any, payable upon the transfer
of shares from the Company to underwriter; and (h) the fees and expenses of the Company’s accountants; and (i) fees and expenses
including “road show”, diligence, and reasonable legal fees and disbursements for Aegis’s counsel.
We
estimate that the total expenses of the offering, excluding underwriting discount and non-accountable expense allowance, will be approximately
$300,000. Upon closing, we have also agreed to reimburse $100,000 of the underwriter’s expenses relating to the offering,
including for road show, diligence, and legal expenses.
Over-Allotment
Option
We
have granted the underwriter an over-allotment option. This option, which is exercisable for up to 45 days after the date of this prospectus,
permits the underwriter to purchase additional shares of common stock and/or Warrants, representing 15% of the Units sold
in the offering. If the underwriter exercises all or part of this option, they will purchase shares of common stock covered by the option
at the public offering price that appears on the cover page of this prospectus, less the underwriting discount.
Stabilization
In
accordance with Regulation M under the Exchange Act, the underwriter may engage in activities that stabilize, maintain or otherwise
affect the price of our common stock, including short sales and purchases to cover positions created by short positions, stabilizing
transactions, syndicate covering transactions, penalty bids and passive market making.
| |
● |
Short
positions involve sales by the underwriter of shares in excess of the number of shares the underwriters are obligated to purchase,
which creates a syndicate short position. The short position may be either a covered short position or a naked short position. In
a covered short position, the number of shares involved in the sales made by the underwriters in excess of the number of shares they
are obligated to purchase is not greater than the number of shares that they may purchase by exercising their option to purchase
additional shares. In a naked short position, the number of shares involved is greater than the number of shares in their option
to purchase additional shares. The underwriter may close out any short position by either exercising its option to purchase
additional shares or purchasing shares in the open market. |
| |
● |
Stabilizing
transactions permit bids to purchase the underlying security as long as the stabilizing bids do not exceed a specific maximum price. |
| |
|
|
| |
● |
Syndicate
covering transactions involve purchases of our common stock in the open market after the distribution has been completed to cover
syndicate short positions. In determining the source of shares to close out the short position, the underwriter will consider, among
other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase shares
through the underwriter’s option to purchase additional shares. If the underwriter sells more shares than could
be covered by the underwriter’s option to purchase additional shares, thereby creating a naked short position, the position
can only be closed out by buying shares in the open market. A naked short position is more likely to be created if the underwriters
are concerned that there could be downward pressure on the price of the shares in the open market after pricing that could adversely
affect investors who purchase in the offering. |
| |
|
|
| |
● |
Penalty
bids permit the underwriter to reclaim a selling concession from a syndicate member when the common stock originally sold
by the syndicate member is purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions. |
| |
|
|
| |
● |
In
passive market making, market makers in our common stock who are underwriters or prospective underwriters may, subject to limitations,
make bids for or purchase shares of our common stock until the time, if any, at which a stabilizing bid is made. |
These
activities may have the effect of raising or maintaining the market price of our common stock or preventing or retarding a decline in
the market price of our common stock. As a result of these activities, the price of our common stock may be higher than the price that
might otherwise exist in the open market. These transactions may be effected on the NYSE American or otherwise and, if commenced,
may be discontinued at any time.
Neither
we nor the underwriter make any representation or prediction as to the direction or magnitude of any effect that the transactions described
above may have on the price of our common stock. In addition, neither we nor the underwriter make any representation that the underwriter
will engage in these stabilizing transactions or that any transaction, once commenced, will not be discontinued without notice.
Offering
Price Determination
The
public offering price was negotiated between the underwriter and us. In determining the public offering price of our common stock,
the underwriter considered:
| ● |
the
history and prospects for the industry in which we compete; |
| |
|
| ● |
our
financial information; |
| |
|
| ● |
the
ability of our management and our business potential and earning prospects; |
| |
|
| ● |
the
prevailing securities markets at the time of this offering; and |
| |
|
| ● |
the
recent market prices of, and the demand for, publicly traded shares of generally comparable companies, as well as the recent market
price of our Company’s common stock. |
Indemnification
We
have agreed to indemnify Aegis, its affiliates and each person controlling Aegis against any losses, claims, damages, judgments, assessments,
costs, and other liabilities, as the same are incurred (including the reasonable fees and expenses of counsel), relating to or arising
out of the offering, undertaken in good faith.
Discretionary
Accounts
The
underwriter has informed us that they do not expect to make sales to accounts over which they exercise discretionary authority
in excess of 5% of the shares of our common stock being offered in this offering.
Lock-Up
Agreements
We
and all of our directors and executive officers have agreed that, for a period of one hundred eighty (180) days, respectively, after
the date of the offering, subject to certain limited exceptions, not to directly or indirectly, without the prior written consent of
Aegis, (a) offer, sell, or otherwise transfer or dispose of, directly or indirectly, any shares of capital stock of the Company or any
securities convertible into or exercisable or exchangeable for shares of capital stock of the Company; or (b) file or caused to be filed
any registration statement with the Commission relating to the offering of any shares of capital stock of the Company or any securities
convertible into or exercisable or exchangeable for shares of capital stock of the Company.
The
prior sentence will not apply to (i) the shares to be sold pursuant to the Underwriting Agreement, (ii) any shares of common stock issued
upon the exercise of an option or other security outstanding on the date of the Offering, (iii) such issuances of options or grants of
restricted stock or other equity-based awards under the Company’s 2021 Equity Incentive Plan and the issuance
of shares issuable upon exercise of any such equity-based awards, (iv) the filing of registration statements on Form S-8, (v) the issuance
of securities to affiliates and subsidiaries of the Company, and, (vi) the issuance of securities in connection with mergers, acquisitions,
joint ventures, licensing arrangements or any other similar non-capital raising transactions.
Aegis,
in its sole discretion, may release the common stock and other securities subject to the lock-up agreements described above in whole
or in part at any time. When determining whether or not to release common stock and other securities from lock-up agreements, Aegis will
consider, among other factors, the holder’s reasons for requesting the release, the number of shares of common stock and other
securities for which the release is being requested and market conditions at the time.
Underwriter
Warrants
We
have agreed to issue to Aegis or its designees warrants to purchase up to a total of 5.0% of the shares of Common Stock sold in this
offering (excluding the shares sold through the exercise of the over-allotment option). Such warrants and underlying shares of Common
Stock are included in this prospectus. The warrants are exercisable at $7.50 per share (125% of the public offering price per
share of Common Stock) commencing on a date which is six (6) months from the commencement of sales of the offering under this
prospectus and expiring on a date which is no more than five (5) years from the commencement of sales of the offering in compliance with
FINRA Rule 5110. The warrants have been deemed compensation by FINRA and are therefore subject to a 6-month lock-up pursuant to Rule
5110 of FINRA. The underwriter (or its permitted assignees under the Rule) will not sell, transfer, assign, pledge, or hypothecate these
warrants or the shares of Common Stock underlying these warrants, nor will it engage in any hedging, short sale, derivative, put, or
call transaction that would result in the effective economic disposition of the warrants or the underlying securities for a period of
180 days from the commencement of sales of the offering. The warrants may be exercised as to all, or a lesser number of shares of Common
Stock and will provide for cashless exercise for the underlying shares. Such warrants will provide for registration rights upon request,
in certain cases. The sole demand registration right provided will not be greater than five years from the commencement of sales of the
public offering in compliance with FINRA Rule 5110(g)(8)(C). The piggyback registration rights provided will not be greater than seven
years from the commencement of sales of the public offering in compliance with FINRA Rule 5110(g)(8)(D). The warrants will have anti-dilution
terms that are consistent with FINRA Rule 5110(g)(8)(E) and (F). We will bear all fees and expenses attendant to registering the securities
issuable on exercise of the warrants other than underwriting commissions incurred and payable by the holders. The exercise price and
number of shares issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend,
extraordinary cash dividend or our recapitalization, reorganization, merger or consolidation. However, the warrant exercise price or
underlying shares will not be adjusted for issuances of shares of Common Stock at a price below the warrant exercise price.
Tail Financing
We have agreed to pay the above cash compensation
to the extent that any fund which the underwriter contacted and introduced to us during the term of our engagement agreement with the
underwriter provides financing or capital in any public or private offering or capital raising transaction during the four (4)-month
period following expiration or termination of our engagement letter with the underwriter. Notwithstanding anything to the contrary
contained herein, the Company has the right to terminate the underwriting agreement for cause in compliance with FINRA Rule 5110(g)(5)(B)(i).
The exercise of such right of termination for cause eliminates the Company’s obligations with respect to the provisions relating
to the tail fees.
Securities Issuance Standstill
We have agreed, subject to certain exceptions,
for a period of eighteen (18) months after the closing date of this offering, that we will not, without the prior written consent of
the underwriter, offer, sell, issue, enter into any agreement to issue or announce the issuance or proposed issuance of any common stock,
shares or share equivalents.
Other
Relationships
Aegis
may in the future provide us and our affiliates with investment banking and financial advisory services for which Aegis may in the future
receive customary fees. Aegis may release, or authorize us to release, as the case may be, the common stock and other securities subject
to the lock-up agreements described above in whole or in part at any time with or without notice.
Offer
restrictions outside the United States
Other
than in the United States, no action has been taken by us or the underwriter that would permit a public offering of the securities offered
by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be
offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with
the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result
in compliance with the applicable rules and regulations of that jurisdiction. Persons who come into possession of this prospectus are
advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus.
This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in
any jurisdiction in which such an offer or a solicitation is unlawful.
Electronic
Distribution
A
prospectus in electronic format may be made available on the websites maintained by the underwriter or selling group members, if any,
participating in the offering. The underwriter may allocate a number of shares to the underwriter and selling group members, if
any, for sale to their online brokerage account holders. Any such allocations for online distributions will be made by the underwriter
on the same basis as other allocations.
Listing
Our
Common Stock listed on the OTC Pink under the symbol “CUBT.”
Transfer
Agent and Registrar
The
transfer agent and registrar for our Common Stock is Issuer Direct Corporation, One Glenwood Ave, Suite 1001, Raleigh, NC 27603; (919)
481-4000.
LEGAL
MATTERS
Certain
legal matters concerning this offering will be passed upon for us by Lucosky Brookman LLP, Woodbridge, New Jersey. Certain legal
matters related to the offering will be passed upon for the underwriter by Kaufman & Canoles, P.C., Richmond, Virginia.
EXPERTS
The
financial statements included in this prospectus and in the registration statement of which it forms a part, have been so included in
reliance on the reports of Daszkal Bolton LLP, our independent registered public accounting firm for the years ended December
31, 2021, and 2020, appearing elsewhere in this prospectus and the registration statement of which it forms a part, given on the authority
of said firms as experts in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We
will file annual, quarterly and other reports, proxy statements and other information with the SEC. You may read and copy any document
we file at the public reference facilities of the SEC at 100 F Street, NE, Washington, D.C. 20549. Our SEC filings are available
to the public at the SEC’s web site at http://www.sec.gov and at our website at http://www.curativebiotech.com. The information
on our website is not (and should not be considered) part of this prospectus and is not incorporated into this prospectus by reference.
We will furnish our stockholders with annual reports containing audited financial statements.
This
prospectus is part of a registration statement on Form S-1 that we filed with the SEC. Certain information in the registration statement
has been omitted from this prospectus in accordance with the rules and regulations of the SEC. We have also filed exhibits and schedules
with the registration statement that are excluded from this prospectus. For further information you may:
| |
● |
read
a copy of the registration statement, including the exhibits and schedules, at sec.gov; or |
| |
|
|
| |
● |
obtain
a copy from the SEC upon payment of the fees prescribed by the SEC. |
INDEX
TO FINANCIAL STATEMENTS
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and
Stockholders
of Curative Biotechnology, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying balance sheets of Curative Biotechnology, Inc. (the Company) at December 31, 2021 and 2020, and the related
statements of operations, deficiency in stockholder’s equity, and cash flows for each of the years in the two-year period ended
December 31, 2021, 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, 2021 and 2020, and the results of its
operations and its cash flows for each of the years in the two-year period ended December 31, 2021, in conformity with accounting principles
generally accepted in the United States of America.
Going
Concern Uncertainty
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As described in Note
3 to the financial statements, the Company has sustained net losses and has accumulated and working capital deficits, which raise substantial
doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are described in Note 3.
The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our opinion is not modified
with respect to this matter.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. 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 audits 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 audits,
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 Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits 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 audits 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 audits
provide a reasonable basis for our opinion.
Critical
Audit Matters
The
critical audit matter communicated below is a matter arising from the current period audit of the financial statements that were communicated
or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial
statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matter
does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
matter below, providing separate opinions on the critical audit matter or on the account or disclosures to which it relates.
Intangible
Assets Impairment Assessments
As
described in Note 4 to the financial statements, the Company has intangible assets of $1.6 million at December 31, 2021, which includes
a non-assignable licensed rights for the development and commercialization of a COVID-19 vaccine. The value of intangible assets makes
up approximately 65% of total assets. In most cases, no directly observable market inputs are available to measure the fair value to
determine if the assets are impaired. Therefore, an estimate is derived indirectly and is based on net present value techniques utilizing
post-tax cash flows and discount rates. The estimates that management used in calculating the net present values depend on assumptions
specific to the nature of the development activities with regard to the amount and timing of projected future cash flows; long-term forecasts;
actions of competitors, future tax and discount rates.
The
principal consideration for our determination that performing procedures relating to the intangible assets impairment assessment is a
critical audit matter is the significant judgment by management when developing the net present value of the intangible assets. This,
in turn, led to a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating management’s
significant assumptions related to the amount and timing of projected future cash flows.
Addressing
the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the financial
statements. These procedures included evaluating the significant assumptions used by management, including the amount and timing of projected
future cash flows. Evaluating management’s assumptions related to the amount and timing of projected future cash flows involved
evaluating whether the assumptions used by management were reasonable considering the current and past performance of similar intangible
assets, the consistency with external market and industry data, and whether these assumptions were consistent with evidence obtained
in other areas of the audit.
/s/
Daszkal Bolton LLP
Daszkal
Bolton LLP
March
25, 2022 (except for Note 2, as to which the date is September 26, 2022)
Boca Raton, Florida
We have served as the Company’s
auditor since 2021
Curative
Biotechnology, Inc
Balance
Sheets
December
31,
The
accompanying notes are an integral part of the financial statements
Curative
Biotechnology, Inc
Statements
of Operations
Year
ended December 31,
The
accompanying notes are an integral part of the financial statements
Curative
Biotechnology, Inc
Statement
of Deficiency in Stockholders’ Equity
| * | | Series A and Series
C Preferred Stock amounts reflected in mezzanine equity |
The
accompanying notes are an integral part of the financial statements
Curative
Biotechnology, Inc
Statements
of Cash Flows
Year
ended December 31,
| | |
2021 | | |
2020 | |
| CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
| Net loss | |
$ | (5,340,354 | ) | |
$ | (4,670,255 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
| Depreciation and amortization | |
| 6,744 | | |
| 5,301 | |
| Share based compensation | |
| 2,889,567 | | |
| 4,302,978 | |
| Amortization of warrant discount | |
| 2,545 | | |
| 11,495 | |
| Amortization of Original Issue Discount | |
| 122,129 | | |
| 19,121 | |
| Amortization of debt discounts | |
| - | | |
| - | |
| Loss on debt extinguishment | |
| 149,350 | | |
| - | |
| Impairment of long lived assets | |
| 16,958 | | |
| 32,136 | |
| Changes in operating assets and liabilities | |
| | | |
| | |
| (Increase) in stock subscription receivable | |
| (25,000 | ) | |
| - | |
| Decrease in other receivable | |
| - | | |
| - | |
| (Increase) in prepaid expenses | |
| (18,294 | ) | |
| - | |
| Increase in accrued interest | |
| - | | |
| - | |
| Increase in accounts payable and accrued expenses | |
| 592,320 | | |
| 109,131 | |
| | |
| | | |
| | |
| Net cash used in operating activities | |
| (1,604,035 | ) | |
| (190,093 | ) |
| | |
| | | |
| | |
| CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
| Purchase of fixed assets | |
| (6,834 | ) | |
| - | |
| Purchase of intangible assets | |
| (14,500 | ) | |
| (34,300 | ) |
| | |
| | | |
| | |
| Net cash used in investing activities | |
| (21,334 | ) | |
| (34,300 | ) |
| | |
| | | |
| | |
| CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
| Cash received for issuance of common stock | |
| 1,573,000 | | |
| - | |
| Cash received for exercise of warrants | |
| 525,000 | | |
| - | |
| Cash received for amounts receivable on notes payable | |
| 70,000 | | |
| - | |
| Cash paid for deferred offering costs | |
| (92,975 | ) | |
| - | |
| Advances from related party | |
| - | | |
| 48,083 | |
| Payments on related party advances | |
| - | | |
| (48,083 | ) |
| Payments on related party notes payable | |
| (50,000 | ) | |
| - | |
| Cash received from related party notes payable | |
| - | | |
| 20,000 | |
| Cash received from third party notes payable | |
| 110,000 | | |
| 365,000 | |
| Repayments of related party notes payable | |
| | | |
| (48,083 | |
| Repayments of note payable | |
| | | |
| | |
| | |
| | | |
| | |
| Net cash provided by financing activities | |
| 2,135,025 | | |
| 385,000 | |
| | |
| | | |
| | |
| Net increase in cash | |
| 509,656 | | |
| 160,607 | |
| Net (decrease) increase in cash | |
| 509,656 | | |
| 160,607 | |
| | |
| | | |
| | |
| CASH, beginning of year | |
| 160,607 | | |
| - | |
| | |
| | | |
| | |
| CASH, end of year | |
$ | 670,263 | | |
$ | 160,607 | |
| SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | |
| | | |
| | |
| Interest paid in cash | |
$ | 10,000 | | |
$ | - | |
| Income taxes paid in cash | |
$ | - | | |
$ | - | |
| Non-Cash Financing Activities: | |
| | | |
| | |
| Common shares issued for intangible assets | |
$ | 1,425,000 | | |
$ | 106,000 | |
| Amortization of noncash prepaid expenses | |
| | | |
| | |
| Warrants issued in conjunction with debt | |
| | | |
| | |
| Deferred offering costs in accounts payable | |
| | | |
| | |
| Common shares issued upon conversion of debt | |
$ | 656,250 | | |
$ | - | |
| Common shares issued upon conversion of preferred stock | |
$ | 1,564,251 | | |
$ | - | |
| Warrants issued as debt discount | |
$ | 9,533 | | |
$ | 54,555 | |
| Series C preferred stock deemed dividend | |
$ | 13,477,055 | | |
$ | 4,440 | |
| Common shares issued to settle liabilities | |
$ | 198,650 | | |
$ | - | |
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
1 - NATURE OF OPERATIONS
Curative
Biotechnology Inc. (f/k/a Connectyx Technologies Holdings Group, Inc.), (CUBT), is a Florida corporation, formed as a Nevada corporation
on June 29, 1995, reincorporated in Florida on October 30, 2007, with a name change November 30, 2020, which conducts business from its
headquarters in Boca Raton, Florida. Curative Biotechnology, Inc. is a development stage biomedical company that seeks to develop, in-license,
sub-license and bring to market products in both the Pharmaceutical and Medical Device space. The Company focuses on products that are
targeted at FDA-defined “Orphan Diseases” with patient populations under 200,000 in the United States. The company leverages
management’s experience and business relationships with Life Science research institutions as well as Life Science industry members
to acquire Life Science candidates that fit within the company’s business model. The company has established a scientific advisory
board with a successful track record of bringing pharmaceuticals to market.
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES
a)
Basis of Presentation The accompanying financial statements have been prepared in accordance with Generally Accepted Accounting Principles
(“GAAP”) in the United States of America (“U.S.”) as promulgated by the Financial Accounting Standards Board
(“FASB”) Accounting Standards Codification (“ASC”).
On
September 26, 2022, the Company effected a 1-for-400 reverse stock split of its common stock and adjusted the ratio at which the Company’s
preferred stock is convertible into common. This also impacts the number of stock options and warrants and their respective exercise
prices. All common shares, stock options, warrants, and per share information presented in the accompanying financial statements and
notes have been adjusted, where applicable, to reflect the reverse split on a retroactive basis for all periods presented. There was
no change in the par value of the Company’s common stock
b)
Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United
States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from these estimates.
(c)
Cash and equivalents The Company considers all highly liquid investments with maturity of three months or less when purchased to
be cash equivalents.
(d)
Prepaid expenses From time to time, the Company may prepay expenses either through the transfer of cash, assets or the issuance of
securities. Prepaid expenses are amortized over the period of benefit.
(e)
Property and equipment All property and equipment are recorded at cost and depreciated over their estimated useful lives, using the
straight-line method. Upon sale or retirement, the cost and related accumulated depreciation are eliminated from their respective accounts,
and the resulting gain or loss is included in the results of operations. Repairs and maintenance charges, which do not increase the useful
lives of the assets, are charged to operations as incurred.
(f)
Intangible Assets The useful life of intangible assets is assessed as either finite or indefinite. Following the initial recognition,
intangible assets are carried at cost less any accumulated amortization and accumulated impairment losses, if any.
Intangible
assets with finite useful lives are carried at cost less accumulated amortization. Amortization is calculated using the straight line
method over the estimated useful lives.
Intangible
assets with indefinite useful lives are not amortized, but are tested for impairment annually. The assessment of indefinite life is reviewed
annually to determine whether the indefinite life continues to be supportable. If not, the change in useful life from indefinite to finite
is made on a prospective basis. If impairment indicators are present, these assets are subject to an impairment review. Any loss resulting
from impairment of intangible assets is expensed in the period the impairment is identified.
(g)
Impairment of Long-Lived Assets A long-lived asset is tested for impairment whenever events or changes in circumstances indicate
that its carrying value amount may not be recoverable. An impairment loss is recognized when the carrying amount of the asset exceeds
the sum of the undiscounted cash flows resulting from its use and eventual disposition. The impairment loss is measured as the amount
by which the carrying amount of the long-lived assets exceeds its fair value.
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES, continued
(h)
Financial Instruments and Fair Value Measurements
ASC
825-10 “Financial Instruments”, allows entities to voluntarily choose to measure certain financial assets and liabilities
at fair value (fair value option). The fair value option may be elected on an instrument-by-instrument basis and is irrevocable, unless
a new election date occurs. If the fair value option is elected for an instrument, unrealized gains and losses for that instrument should
be reported in earnings at each subsequent reporting date. The Company did not elect to apply the fair value option to any outstanding
instruments.
ASC
825 also requires disclosures of the fair value of financial instruments. The carrying value of the Company’s current financial
instruments, which include cash and cash equivalents, accounts payable and accrued liabilities approximates their fair values because
of the short-term maturities of these instruments.
FASB
ASC 820 “Fair Value Measurement” clarifies that fair value is an exit price, representing the amount that would be received
to sell an asset or paid to transfer a liability in an orderly transaction between market participants. It also requires disclosure about
how fair value is determined for assets and liabilities and establishes a hierarchy for which these assets and liabilities must be grouped,
based on significant levels of inputs as follows:
Level
1: Quoted prices in active markets for identical assets or liabilities.
Level
2: Quoted prices in active markets for similar assets and liabilities and inputs that are observable for the asset or liability.
Level
3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
The
determination of where assets and liabilities fall within this hierarchy is based upon the lowest level of input that is significant
to the fair value measurement.
(i)
Related Party Transactions All transactions with related parties are in the normal course of operations and are measured at the exchange
amount.
(j)
Revenue Recognition The Company adopted Accounting Standards Codification, (“ASC”), 606, “Revenue from Contracts
with Customer” on January 1, 2018. This revenue recognition standard has a five step process: a) Determine whether a contract exists;
b) Identify the performance obligations; c) Determine the transaction price; d) Allocate the transaction price; e) Recognize revenue
when (or as) performance obligations are satisfied. The Company’s financial statements are prepared under the accrual method of
accounting. Revenues will be recognized when pervasive evidence of an arrangement exists, services have been rendered (product delivered),
the sales price is fixed or determinable, and collectability is reasonably assured. This occurs only when the product(s) is ordered and
subsequently delivered.
(k)
Stock based compensation Stock-based compensation is accounted for based on the requirements of the Share-Based Payment Topic of
ASC 718 which requires recognition in the consolidated financial statements of the cost of employee and director services received in
exchange for an award of equity instruments over the period the employee or director is required to perform the services in exchange
for the award. The ASC also requires measurement of the cost of employee and director services received in exchange for an award based
on the grant-date fair value of the award. Pursuant to ASC 505-50, for share-based payments to non-employees, compensation expense is
determined at the “measurement date.” The expense is recognized over the service period of the award. Until the measurement
date is reached, the total amount of compensation expense remains uncertain. The Company initially records compensation expense based
on the fair value of the award at the reporting date.
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES, continued
(l)
Income Taxes Provisions for income taxes are based on taxes payable or refundable for the current year and deferred taxes on temporary
differences between the amount of taxable income and pretax financial income, and between the tax bases of assets and liabilities and
their reported amounts in the financial statements. Deferred tax assets and liabilities are included in the consolidated financial statements
at currently enacted income tax rates applicable to the period in which the deferred tax assets and liabilities are expected to be realized
or settled as prescribed in FASB ASC 740. As changes in tax laws or rates are enacted, deferred tax assets and liabilities are adjusted
through the provision for income taxes. Tax positions initially need to be recognized in the financial statements when it is more-likely-than-not
the positions will be sustained upon examination by the tax authorities.
(m)
Net income (loss) per share Basic loss per share is computed by dividing the net income (loss) by the weighted average number of
common shares outstanding during the period. Diluted loss per share reflects the potential dilution that could occur if securities or
other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that
shared in the earnings of the Company. Diluted loss per share is computed by dividing the loss available to stockholders by the weighted
average number of shares outstanding for the period and dilutive potential shares outstanding unless consideration of such dilutive potential
shares would result in anti-dilution. There were no dilutive common stock equivalents for the years ended December 31, 2021 and 2020.
(n)
Recent Accounting Pronouncements The Company has considered recent accounting pronouncements during the preparation of these financial
statements.
NOTE
3 - LIQUIDITY AND GOING CONCERN CONSIDERATIONS
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company’s
financial position and operating results raise substantial doubt about the Company’s ability to continue as a going concern, as
reflected by the net loss of approximately $5.3 million and accumulated deficit of approximately $26.9 million through December 31, 2021.
The ability of the Company to continue as a going concern is dependent upon commencing operations, developing sales and obtaining additional
capital and financing. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue
as a going concern. The Company is currently seeking additional capital to allow it to grow its operations
NOTE
4 - INTANGIBLE ASSETS
During
the 4th quarter 2021, the Company acquired the following intangible asset:
(a)
MABT Covid-19 license The Company entered into a licensing agreement with Mid-Atlantic BioTheraputics, Inc., (MABT), to license MABT’s
COVID-19 vaccine which is composed of a recombinant S1 and S2 protein from SARS-CoV-2 plus an IMT504 adjuvant. The Company issued 31,250
shares of common stock valued at $1,425,000 to acquire this license.
During
the 4th quarter 2020, the Company acquired the following intangible assets:
(b)
Website In December 2020, the Company contracted with a third party to develop and produce a new website for the Company for a contract
price of $22,500,
one-half in cash and one-half in common stock of the Company. The Company is amortizing this cost over 3
years. This website was
placed into service in March 2021. Amortization expense for the year ended December 31, 2021 was $6,250.
In
March 2020, the Company contracted with a third party to develop and produce a new website for the Company for a contract price of $15,000,
for which the Company issued 3,750 shares of common stock.
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
4 - INTANGIBLE ASSETS, continued
(c)
Patent rights option In October 2020, the Company entered into an agreement for the option to purchase certain exclusive license
rights for US Patent No. 8,287,505 Ophthalmic Drop Dispensing Tip Assembly, issued October 16, 2012, from IEM, Inc., (IEM), the sole
owner of this patent. The cost of this option was $1,800.
The
Company had until September 30, 2021, to advise IEM in writing that it wishes to exercise this Option Right and pay IEM $50,000 in exchange
for an exclusive world-wide, royalty free perpetual license. In September 2021, the Company exercised the option to extend the deadline
for notification in the contract with IEM, from September 30, 2020 to March 31, 2022, in exchange for the payment of $1,000. The Company
is evaluating the Patent rights, potential products and markets under this Patent.
(d)
IMT504 Patent license In October 2020, the Company entered into a license agreement with MidAtlantic BioTheraputics, Inc., (MABT),
to license the development of a pharmaceutical compound known as IMT504, as immununotherapy for late stage symptomatic rabies. The license
is for worldwide use. There are certain conditions to the license, principally that the Company raise $6.5 million to fund the development.
There is not a time limit on raising these funds unless the Company utilizes a public offering process, such as Regulation A.
The
total cost for this license is 50,000
shares of the Company’s common stock, issuable in three tranches - 1-
17,500
shares upon execution of the license (which have been issued, valued at $91,000),
2-
16,250
shares upon the submission of an Investigational New Drug (IND) to the FDA and 3-
16,250
shares upon the successful completion of the first rabies clinical trial of this IND. This license calls for royalties of 50% of the
net profit, after reimbursement for development costs, of successfully marketed products utilizing IMT504.
(e)
National Institute of Health (NIH) Patent license #1 In October 2020, the Company entered into an exclusive 24 month evaluation license
of Provisional Patent Application No. 62/199,707, filed July 31, 2015; PCT Application No. PCT/US2016/044777 filed July 29, 2016 and
Patent No. 10,548,987 issued February 4, 2020. This license is for the evaluation of and development of an anti-CD56 antibody drug conjugate
for the treatment of glioblastoma. Should the Company develop a marketable product, the Company is then required to negotiate a new license
with appropriate royalties.
This
license calls for the payment of a non-creditable non-refundable license issue royalty of $10,000, paid ½ at issuance and ½
on the one year anniversary.
(f)
National Institute of Health (NIH) Patent license #2 In January 2021 the Company entered into an NIH exclusive 36 month worldwide
license of Provisional Patent Application No. 62/899,899, filed September 13, 2019 and PCT Application No. PCT/US2020/050540 filed September
11, 2020. This license is for the development of ocular metformin formulation for the treatment of retinal degenerative diseases.
This
license requires two separate royalty streams of payments:
First
is a royalty equal to the unreimbursed patent expenses paid by NIH, with an initial amount of $8,500 due within 30 days of execution
of the license. At the first anniversary of the license NIH will supply a statement of additional unreimbursed patent expenses paid by
NIH during the year, of which the Company is required to pay 50%, with the remaining balance due on the third anniversary.
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
4 - INTANGIBLE ASSETS, continued
(f)
National Institute of Health (NIH) Patent license #2, continued
Second
is an ongoing royalty schedule: an initial royalty of $5,000 upon execution of the license, and annually thereafter as the minimum royalty
amount. The license can be extended on the third anniversary to the remaining life of the licensed patent by the payment of a one-time non-refundable, non-creditable royalty of $45,000. There are three benchmark royalties - $75,000 upon the initiation of the first Phase 2 Clinical Study; $300,000 upon the completion of Phase 3 Clinical Study and $600,000 upon the FDA approval of the first Licensed Product. Upon first commercial sale there is a royalty of $100,000 each for the United States, Canada, European Union and Asian region. Last is a 3.5% of net sales royalty.
The
patent rights and patent licenses are under development, therefore amortization of the costs has not commenced, as these patent rights
and licenses have not been placed in service.
NOTE
5 - RELATED PARTY TRANSACTIONS
From
time to time the Company may enter into non-arm’s length transactions with related parties, however the Company exercises
its best efforts to ensure that such transactions are valued on a basis comparable to a true arm’s length transaction.
During
2020, one officer advanced $48,083 to the Company, carrying no stated interest rate nor maturity. This advance was repaid during 2020.
During
the second quarter of 2021, the remaining two notes from officers of the Company, totaling $40,000 of principal and $10,000 of OID, were
repaid in cash.
NOTE
6 - NOTES PAYABLE
During
the first quarter 2021, 13 of the 15 total notes were converted into 27,343 shares of common stock.
In
January 2021, the amounts receivable for notes payable were received.
During
the first quarter of 2021, the Company entered into two (2) notes payable with a face amount of $137,500, including 25% Original Issue
Discount (OID), for a total amount of cash received of $110,000. The notes are identical and carry a maturity of six months from inception
and a 25% OID. The maturity is extendable at the Company’s option for up to three months with a 3% per month extension fee. In
connection with the notes, the Company issued warrants to purchase 2,750 shares of common stock of the Company, which were recorded
as a discount in the amount of $9,533, which is being amortized over the term of the notes. These notes are collateralized by Preferred
C shares representing 9.24% of the issued and outstanding common stock shares. Two officers holding Preferred C shares have pledged the
Preferred C shares as this collateral.
During
2020, the Company issued thirteen (13) notes payable with a face amount of $568,750,
including 25%
OID, for a total amount of cash received of $455,000.
The notes are identical and carry a six-month maturity. The
maturity is extendable at the Company’s option for up to three months with a 3% per month extension fee.
In connection with the notes, the Company issued warrants to purchase 11,375 shares of common stock of the Company, which
were recorded as a discount in the amount of $54,555,
which is being amortized over the term of the notes.
These notes are collateralized by Preferred C shares representing 9.24%
of the issued and outstanding common stock shares. Two officers holding Preferred C shares have pledged the Preferred C shares as this
collateral. During the first quarter of 2021, 13 of the 15 note holders converted their notes into shares of common stock at the rate
of $24.00 per share, for a total of 27,343 shares of common stock for a total of $656,250
convertible debt.
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
7 - CONVERTIBLE NOTE PAYABLE
CONVERTIBLE SENIOR SECURED NOTE PAYABLE
In
April 2013, the Company entered into a convertible note in the principal amount of $97,500, which carried a 4% interest rate. This note
was convertible at a conversion price equal to the lesser of 90% of the previous 10 day closing price or $0.40 per share. The balance
of the convertible note, including accrued interest, was $128,700 at December 31, 2020. During 2021, the note holder filed a lawsuit
to enforce the conversion of this note, which was settled in August 2021, via the payment of $100,000 and the issuance of 5,000 shares
of common stock. (See Note 9)
NOTE
8 - LIABILITY TO ISSUE COMMON STOCK
In
March 2020, the Company entered into an agreement to issue 2,500 shares of the Company’s common stock in exchange for services
valued at $7,400. These shares were issued in June 2021.
NOTE
9 – DEFICIENCY IN STOCKHOLDERS EQUITY
At
December 31, 2021 and 2020, the Company has 1,100,000,000 shares of par value $0.0001 common stock authorized and 1,426,629 and 832,500
issued and outstanding, respectively. At December 31, 2021 and 2020, the Company has 200,000,000 shares of $0.0001 par value preferred
stock authorized.
The
Company accounts for the Series A and Series C preferred stock in accordance with FASB Accounting Standards Codification (ASC) 480, as
mezzanine equity due to Series A having a redemption provision and Series C being convertible into a variable number of common shares.
SCHEDULE
OF STOCKHOLDERS EQUITY
| | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | |
| | |
Series A | | |
Series B | | |
Series C | | |
Total | |
| | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | |
| January 1, 2020 | |
| 34,109,750 | | |
$ | 3,411 | | |
| 293,000 | | |
$ | 29 | | |
| - | | |
$ | - | | |
| 34,402,750 | | |
$ | 3,440 | |
| Issuance of shares for services | |
| 100,000,000 | | |
| 10,000 | | |
| - | | |
| - | | |
| 30,000,000 | | |
| 3,000 | | |
| 130,000,000 | | |
| 13,000 | |
| December 31, 2020 | |
| 134,109,750 | | |
| 13,411 | | |
| 293,000 | | |
| 29 | | |
| 30,000,000 | | |
| 3,000 | | |
| 164,402,750 | | |
| 16,440 | |
| Beginning Balance | |
| 134,109,750 | | |
| 13,411 | | |
| 293,000 | | |
| 29 | | |
| 30,000,000 | | |
| 3,000 | | |
| 164,402,750 | | |
| 16,440 | |
| Conversion to common shares | |
| (134,109,750 | ) | |
| (13,411 | ) | |
| (212,000 | ) | |
| (21 | ) | |
| - | | |
| - | | |
| (134,321,750 | ) | |
| (13,432 | ) |
| no transactions | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| no transactions, shares | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| December 31, 2021 | |
| - | | |
$ | - | | |
| 81,000 | | |
$ | 8 | | |
| 30,000,000 | | |
$ | 3,000 | | |
| 30,081,000 | | |
$ | 3,008 | |
| Ending Balance | |
| - | | |
$ | - | | |
| 81,000 | | |
$ | 8 | | |
| 30,000,000 | | |
$ | 3,000 | | |
| 30,081,000 | | |
$ | 3,008 | |
The
preferred shares have the following respective rights and privileges:
Series
A Preferred carry 10 votes for each share of common stock that each Series A shares are convertible into at the record date; is convertible
into common stock aggregating 35% of the total issued and outstanding common shares at conversion date post conversion; are redeemable
at the Company’s option for the greater of 45% of the total market value of the common shares or the calculation of the book value
of the Company made by an independent audit firm or $5,000,000.
Series
B Preferred are convertible in common shares of common stock at a conversion price of $3.00 per share; are redeemable at the Company’s
option at a price of 125% of the purchase price paid for the shares; carry one vote for each common share that the Series B is convertible
into at the record date; are senior to all other securities in the event of a liquidation.
Series
C Preferred are convertible into common stock aggregating 30% of the total issued and outstanding common shares at conversion date post
conversion; carry ten votes for each common share that the Series C is convertible into at the record date.
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
9 – DEFICIENCY IN STOCKHOLDERS EQUITY, continued
During
the fourth quarter 2021, the Company issued 32,898 shares of common stock and 64,788 warrants for the purchase of common stock
in exchange for $523,000 in cash and $25,000 in deposit in transit. During the fourth quarter 2021, the Company issued 500 shares
of common stock, valued at $21,960 for services. During the fourth quarter 2021, the Company issued 31,250 shares of common stock,
valued at $1,425,000 for the license to MABT’s COVID-19 vaccine.
During
the third quarter 2021, the Company issued 10,902 shares of common stock and 10,590 warrants for the purchase of common stock in
exchange for $425,000 in cash. During the third quarter 2021, the Company issued 625 shares of common stock, valued at $22,500, to
an individual for services to be rendered as a member of the Company’s Advisory Board. These shares vest 150 immediately, 150
in December 2021, 150 in April 2022 and 175 in August 2022. During the third quarter 2021, the Company issued 750 shares of
common stock, valued at $36,720, to an individual for services rendered as a member of the Company’s Board of Directors. During
the third quarter 2021, the Company issued 625 shares of common stock, valued at $28,475, to an individual for services to be rendered
as a member of the Company’s Advisory Board. These shares vested immediately. During the third quarter the Company issued 5,000
shares of common stock, valued at $180,000, to settle the lawsuit brought to enforce the convertible note. During the third quarter 2021,
9,000 shares of the Series B preferred stock was converted into 3,000 shares of common stock.
During
the second quarter 2021, the Company issued 25,000 shares of common stock and 12,500 warrants for the purchase of common stock
in exchange for $600,000 in cash. The warrants mature in May 2026, and carry an exercise price of $44.00 per share. During the second
quarter 2021, the Company issued 2,500 shares of common stock to settle the liability to issue shares.
During
the second quarter 2021, the Company issued 625 shares of common stock to an individual for services to be rendered as a member of
the Company’s Advisory Board. These shares vest 150 immediately, 150 in August 2021, 150 in December 2021 and 175 in
April 2022. During the second quarter 2021, the Company issued 2,100 shares of common stock to an employee for services to be rendered.
These shares vest 525 immediately, 525 in September 2021, 525 in December 2021 and 525 in March 2022. 2,100 of these
shares to the two (2) individuals were issued and recorded as a prepaid expense to be amortized as they vest.
During
the first quarter 2021, the Company issued 312 shares of common stock in exchange for services valued at $5,575, or $17.84 per share.
During the first quarter 2021, the Company issued 937 shares of common stock to settle a payable in the amount of $11,250. During
the first quarter 2021, all of the Series A preferred stock was converted into 339,591 shares of common stock. During the first quarter
2021, 203,000 shares of the Series B preferred stock was converted into 67,666 shares of common stock. During the first quarter of
2021, 13 of the 15 note holders converted their note receivable into shares of common stock at the rate of $24.00 per share, for a total
of 27,343 shares of common stock for a total of $656,250 convertible debt. During the first quarter 2021, the Company issued 26,250
shares of common stock upon receipt of $525,000 in cash for the exercise of 26,250 warrants. During the first quarter 2021, the Company
issued 16,250 shares of common stock for the exercise of 16,250 warrants in exchange for services valued at $325,000.
During
the 4th quarter 2020, the Company issued 4,250 shares of common stock in exchange for services valued at $36,800, or $8.64
per share. During the 4th quarter 2020, the Company issued 21,250 shares of common stock to acquire intangible assets valued
at $106,000, or $5.00 per share.
During
the 4th quarter 2020, the Company issued 100,000,000 shares of Series A preferred stock in exchange for services valued at
$1,560,840, or $0.0156 per share. During the 4th quarter 2020, the Company issued 30,000,000 shares of Series C preferred
stock in exchange for services valued at $4,562,062, or $0.152 per share. 50% of the Series C shares vested upon issuance and the other
50% vest in May 2021. The Company recorded 50% of the compensation expense upon issuance and 50% as a prepaid expense which will be amortized
over the remaining of the six month service period.
During
the 2nd quarter 2020, the Company issued 3,125 shares of common stock in exchange for services valued at $23,300, or $7.46 per
share.
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
9 – DEFICIENCY IN STOCKHOLDERS EQUITY, continued
During
the 1st quarter 2020, the Company issued 3,750 shares of common stock in exchange for services valued at $15,000, or $4.00 per share.
A
deemed dividend for the Series C preferred stock is calculated and recorded as shares of common stock are issued. This is calculated
as the increase in common shares that the Series C would receive upon conversion, as a result of the change in the number of common shares
issued and outstanding during the period multiplied by the closing price of the common stock at the end of the period. The deemed dividend
was $13,477,055 and $4,440 for the year ended December 31, 2021 and 202, respectively.
NOTE
10 - WARRANTS
During
the fourth quarter 2021, the Company issued 1,008 warrants for the purchase of common stock of the Company in conjunction with the
sale of 1,008 shares of common stock for cash. These warrants expire in December 2024 and have an exercise price of $44.00 per share.
During the fourth quarter 2021, the Company issued 63,780 warrants for the purchase of common stock of the Company in conjunction
with the sale of 31,890 shares of common stock for cash and subscription receivable. These warrants expire in December 2024 and have
an exercise price of $36.00 and $60.00 per share.
During
the third quarter 2021, the Company issued 10,590 warrants for the purchase of common stock of the Company in conjunction with the
sale of 10,902 shares of common stock for cash. These warrants expire in July and August 2026 and have an exercise price of $60.00
and $56.00 per share. During the third quarter 2021, the Company issued 2,500 warrants for the purchase of common stock of the Company
in exchange for services as a member of the Board of Directors. These warrants expire in July 2024 and have an exercise price of $49.60
per share and have a cash-less exercise provision. These warrants were recorded at a total value of $34,382.
During
the second quarter 2021, the Company issued 12,500 warrants for the purchase of common stock of the Company in conjunction with the
sale of 25,000 shares of common stock for cash. These warrants expire in May 2026 and have an exercise price of $44.00 per share.
During the second quarter 2021, the Company issued 12,500 warrants for the purchase of common stock of the Company in exchange for
services as a member of the Board of Directors. These warrants expire in June 2024 and have an exercise price of $80.00 per share. The
warrants were recorded at a total value of $87,249. During the second quarter 2021, the Company issued 7,500 warrants for the purchase
of common stock of the Company in exchange for legal services. These warrants expire in May 2026 and have an exercise price of $40.00
per share. The warrants were recorded at a total value of $155,717.
During
the second quarter 2021, the Company issued 2,500 warrants for the purchase of common stock of the Company in exchange for services.
These warrants expire in May 2026 and have an exercise price of $40.00 per share. The warrants were recorded at a total value of $51,906
and vest 625 shares on May 20, 2021 and September 20, 2021, January 20, 2022 and May 20, 2022.
During
the first quarter 2021, the Company issued 26,250 shares of common stock upon receipt of $525,000 in cash for the exercise of 26,250
warrants. During the first quarter 2021, the Company issued 16,250 shares of common stock in exchange for services valued at $325,000
for the exercise of 16,250 warrants.
In
the first quarter 2021, the Company issued 2,750 warrants
for the purchase of common stock of the Company in conjunction with the short-term debt at the rate of 2.5 warrants for each $100
loaned. These warrants carry an expiration of thirty-six months from issuance; an exercise price of $20.00 per
share and are exercisable immediately. The warrants were recorded at a total value of $9,533.
In
the first quarter 2021, the Company issued 12,500 warrants for services. These warrants carry an expiration of 60 months from issuance
and an exercise price of $20.00 per share. The warrants were recorded at a total value of $40,600.
The
method utilized to value the warrants was the Black-Scholes model with the following assumption ranges: Expected life - three or five
years; stock price between $16.00 and $40.00; volatility between 60.51 and 31.56; exercise price between $20.00 and $80.00 and bond equivalent
yield rate between 0.09% and 0.83%.
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
10 - WARRANTS, continued
During
the 4th quarter 2020, the Company issued 11,375 warrants
for the purchase of common stock of the
Company in conjunction with the issuance of short-term debt at the rate of 2.5 warrants for each $100 loaned.
These warrants carry an expiration of thirty-six months from issuance; an exercise price of $20.00 per
share and are exercisable immediately. These warrants were valued at $54,555,
and are being amortized to the maturity of the related debt.
During
the 4th quarter 2020, the Company issued 16,875 warrants to two people for services. These warrants carry an expiration
of 60 months from issuance and an exercise price of $20.00 per share. These warrants were valued at $44,135, and are being amortized over
the service period.
The
method utilized to value the warrants was the Black-Scholes model with the following assumption ranges: Expected life three years; stock
price $12.00; volatility between 109.96 and 30.22; exercise price $20.00 and bond equivalent yield rate between 0.08% and 0.11%.
NOTE
11 - OPTIONS
In
the third quarter of 2021, the Company issued options in conjunction with an agreement for Board of Advisor services and the evaluation
of certain potential intangible asset acquisitions. These options call for an undivided 1% of the fully diluted issued and outstanding
shares upon exercise. These options amounted to 20,202 shares at issuance date. These option s contain a single recalculation upon
the completion of a reverse split of the existing common stock and the Company raising a minimum of $5 million in an offering. These
options carry an exercise price of $44.00 per share and expire in September 2031. These options were valued at $436,908 and vest 50% upon
issuance and 50% in September 2022.
The
method utilized to value the options was the Black-Scholes model with the following assumption ranges: Expected life - ten
years; stock price $45.60;
volatility 35.13;
exercise price $44.00
and bond equivalent yield rate 1.47%.
NOTE
11 - EQUITY INCENTIVE PLAN
On
August 26, 2021, the Company adopted a equity incentive plan providing for the issuance of shares of common stock, options or SARs with
a rolling maximum number equal to 10% of the issued and outstanding Common Shares set at the beginning of each fiscal year. The Company
may grant incentives to its directors, officers, employees and service providers. The options are exercisable for a maximum of up to
ten years from the date of grant and may be subject to vesting provisions as set by the Plan Administrator.
During
the quarter ended March 31, 2022, a total of 2,500 shares of common stock and 18,641 options at a weighted-average exercise price
of $20.70 per share were granted to employees exercisable for a period of five years with immediate vesting. The weighted-average fair
value attributable to options granted in 2022 was $8.32.
The
fair value of the stock options recognized in the period has been estimated using the Black-Scholes option pricing model.
Assumptions
used in the pricing model are as provided below.
SCHEDULE
OF FAIR VALUE OF STOCK OPTION ASSUMPTIONS
| Risk-free interest rate | |
| 1.55 | % |
| Exercise price | |
$ | 20.70 | |
| Expected life | |
| 5 years | |
| Expected volatility | |
| 44.12 | % |
| Expected dividends | |
| - | |
The
Company recognized a equity incentive expense of $243,435 for the six months ended June 30, 2022.
As
of June 30, 2022, there were 18,641
fully vested options outstanding with a weighted average exercise price of $20.70
per share. There were no
non-vested options outstanding.
A
summary of the Company’s stock option plan and changes during the six months ended June 30, 2022 is as follows:
SCHEDULE
OF STOCK OPTION ACTIVITY
| | |
Number of options | | |
Weighted average exercise price | |
| Balance - beginning of the year | |
| - | | |
$ | - | |
| Granted | |
| 18,641 | | |
| 20.70 | |
| Exercised | |
| - | | |
| - | |
| Cancelled | |
| - | | |
| - | |
| Balance - end of period | |
| 18,641 | | |
$ | 20.70 | |
The
aggregate intrinsic value of vested share options (the market value less the exercise price) at June 30, 2022 was zero.
NOTE
12 - FINANCIAL INSTRUMENTS
(a)
Liquidity Risk Liquidity risk is the risk that the Company will not be able to meet its obligations associated with financial liabilities.
The Company relies on cash flows generated from operations, as well as injections of capital through the issuance of the Company’s
capital stock to settle its liabilities when they become due.
(b)
Interest Rate Risk The Company is not exposed to significant interest rate risk due to the short-term maturity of its monetary current
assets and current liabilities.
NOTE
13 - GENERAL AND ADMINISTRATIVE EXPENSES
SCHEDULE
OF GENERAL AND ADMINISTRATIVE EXPENSE
| | |
2021 | | |
2020 | |
| | |
Year ended December 31, | |
| | |
2021 | | |
2020 | |
| Salaries | |
$ | 1,016,881 | | |
$ | 143,065 | |
| Share based compensation | |
| 2,889,567 | | |
| 4,302,978 | |
| Professional fees | |
| 225,384 | | |
| 117,860 | |
| Other | |
| 79,523 | | |
| 34,399 | |
| Total general and administrative expenses | |
$ | 4,211,355 | | |
$ | 4,598,302 | |
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
14 - IMPAIRMENT OF LONG-LIVED ASSETS
NOTE
12 - IMPAIRMENT OF LONG LIVED ASSETS
In
the fourth quarter the Company determined that its fixed assets were obsolete and wrote off the undepreciated balance of $1,958.
In
March 2021, when the Company’s new website was placed in service, the remaining unamortized cost of the Company’s old website
was written off, for a total of $15,000.
During
the 4th quarter 2020, the Company elected to abandon certain intangible assets it had been attempting to commercialize under
previous management. As such the Company recorded a $34,516 impairment charge.
NOTE
15 - INCOME TAXES
The
Company recognizes deferred tax assets and liabilities for the tax effects of differences between the financial statements and tax basis
of assets and liabilities. A valuation allowance is established to reduce the deferred tax assets if it is more likely than not that
a deferred tax asset will not be realized.
The
components of income tax provision (benefit) related to continuing operations are as follows at December 31:
SCHEDULE
OF COMPONENTS OF INCOME TAX EXPENSE
| | |
| 2021 | | |
| 2020 | |
| Current | |
$ | - | | |
$ | - | |
| Deferred | |
$ | - | | |
$ | - | |
| Total tax provisions | |
$ | - | | |
$ | - | |
The
following is a reconciliation of the effective income tax rate with the statutory income tax rate at December 31:
SCHEDULE
OF EFFECTIVE RECONCILIATION INCOME TAX RATE
| | |
2021 | | |
2020 | |
| U.S. Federal statutory income tax rate | |
| (21 | )% | |
| (21 | )% |
| State income tax, net of federal benefit | |
| (4.5 | )% | |
| (4.5 | )% |
| Valuation allowance | |
| 25.5 | % | |
| 25.5 | % |
| Total | |
| 0.0 | % | |
| 0.0 | % |
The
net deferred tax assets and liabilities included in the financial statements consist of the following amounts at December 31:
SCHEDULE
OF DEFERRED TAX ASSETS AND LIABILITIES
| | |
2021 | | |
2020 | |
| Deferred tax assets: | |
| | | |
| | |
| Net operating loss carry forwards | |
$ | 1,337,957 | | |
$ | 831,988 | |
| Stock based compensation | |
| 1,600,548 | | |
| 958,197 | |
| Other | |
| - | | |
| (10,061 | ) |
| Total | |
| 2,938,505 | | |
| 1,780,124 | |
| Deferred tax liabilities: | |
| - | | |
| - | |
| Less: valuation allowance | |
| (2,938,505 | ) | |
| (1,780,124 | ) |
| Net deferred tax assets | |
$ | - | | |
$ | - | |
Curative
Biotechnology, Inc
Notes
to Financial Statements
NOTE
15 - INCOME TAXES, continued
The
change in valuation allowance was ($1,158,381) and ($1,021,331) for the years ended December 31, 2021 and 2020, respectively. We have
recorded a 100% valuation allowance related to the deferred tax asset for the income from operations.
The
ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the period in which temporary
differences become deductible. In accordance with the provisions of ASC 740: Income Taxes, we record a liability for uncertain tax positions
when it is probable that a loss has been incurred and the amount can be reasonably estimated. At December 31, 2021 and 2020, we have
no liabilities for uncertain tax positions. We continually evaluate expiring statutes of limitations, audits, proposed settlements, changes
in tax law and new authoritative rulings.
NOTE
16 - COMMITMENTS AND CONTINGENCIES
(a)
Other The Company is subject to asserted claims and liabilities that arise in the ordinary course of business. The Company maintains
insurance policies to mitigate potential losses from these actions. In the opinion of management, the amount of the ultimate liability
with respect to those actions will not materially affect the Company’s financial position or results of operations.
NOTE
17 - CONCENTRATIONS OF CREDIT RISK
(a)
Cash The Company maintains its cash in bank deposit accounts, which may, at times, may exceed federally insured limits. The Company
had $416,178 and no cash balance in excess of FDIC insured limits at December 31, 2021 and 2020.
NOTE
18 - COVID-19 PANDEMIC AND VARIANTS
The
full extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and financial condition,
will depend on future developments that are uncertain, including as a result of new information that may emerge concerning COVID-19 and
the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international customers
and markets. We have made estimates of the impact of COVID-19 within our financial statements, and although there is currently no major
impact, there may be changes to those estimates in future periods.
NOTE
19 - SUBSEQUENT EVENTS
(a)
Intangible Assets In March 2022, the Company entered into a Cooperative Research and Development Agreement, (CRADA) with the National
Institute of Health, (NIH). This is the next step in the process to commercialize NIH Patent License #2. The CRADA is for the
clinical evaluation of the Company’s proprietary ocular metformin formulation. The National Eye Institute, (NEI), will conduct
clinical studies under NIH protocols and the Company will provide the proprietary drug for the clinical studies. The terms of the CRADA
are confidential.
(b)
Senior Secured Note In March 2022, the Company issued a 12 month Senior Secured Note with a face amount of $1,142,857,
with a stated 12.5%
original issue discount (OID). The Note carries a 12.5% interest rate with interest only payable monthly from April through August 2022. The
Company received $874,286
in cash, net of the OID of $142,857and
legal and other fees in the amount of $125,714.
The Note was issued to Puritan Partners, LLC, an institutional investor.
Beginning
in September 2022, the Company is required to make monthly redemptions at the rate of 110% of one seventh of the original principal amount,
($179,592), plus interest. It also carries a mandatory prepayment at 125% of the original principal amount, or $1,428,571, less any redemptions
made, upon the completion of a Qualified Offering, as defined.
The
Note is convertible into common stock of the Company upon an event of default, as defined.
The
lender received five-year warrants to purchase 57,142 shares of common stock of the Company, with an
exercise price of $0.0001
per share. These warrants were recorded as debt
discount in the amount of $1.0
million which will be amortized over the term
of the Note. The warrants can be exercised on a cash-less basis if a registration statement for the common shares underlying the warrants
is not declared effective by September 2022.
The
Note is secured by all the tangible and intangible assets of the Company.
(c)
Deficiency in Stockholders Equity Subsequent to December 31, 2021 the Company issued 2,500
shares of common stock valued at $51,750,
as a bonus to an officer of the Company.
In
January 2022, the $25,000 common stock subscription was received.
(d)
Options In January 2022, the Company issued to three employees an aggregate of 18,663 five-year term Options at a strike price
of $20.70 to purchase $155,250 worth of common shares, as a bonus to Company officers and employees.
(e) Reverse Stock Split On September
26, 2022, the Company effected a 1-for-400 reverse stock split of its common stock and adjusted the ratio at which the Company’s
preferred stock is convertible into common. This also impacts the number of stock options and warrants and their respective exercise
prices. All common shares, stock options, warrants, and per share information presented in the accompanying financial statements and
notes have been adjusted, where applicable, to reflect the reverse split on a retroactive basis for all periods presented. There was
no change in the par value of the Company’s common stock.
Curative
Biotechnology, Inc
Condensed
Balance Sheets
The
accompanying notes are an integral part of the unaudited condensed financial statements
Curative
Biotechnology, Inc
Condensed
Statements of Operations
(Unaudited)
The
accompanying notes are an integral part of the financial statements
Curative
Biotechnology, Inc
Condensed
Statement of Deficiency in Stockholders’ Equity
(Unaudited)
Nine
months ended September 30, 2022
Series
C Preferred Stock amounts reflected in mezzanine equity
The
accompanying notes are an integral part of the unaudited condensed financial statements
Curative
Biotechnology, Inc
Condensed
Statement of Deficiency in Stockholders’ Equity
(Unaudited)
Nine
months ended September 30, 2021
| | |
Number of Shares | | |
Par Value | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| | |
Common | | |
Preferred | | |
Common | | |
Preferred | | |
Capital | | |
Deficit | | |
Deficit | |
| Balance, January 1, 2021 | |
| 832,500 | | |
| 164,402,750 | | |
$ | 83 | | |
$ | 29 | | |
$ | 3,577,875 | | |
$ | (8,099,627 | ) | |
$ | (4,521,640 | ) |
| Series B preferred converted to common | |
| 70,666 | | |
| (212,000 | ) | |
| 7 | | |
| (21 | ) | |
| 14 | | |
| - | | |
| - | |
| Series A preferred converted to common | |
| 339,591 | | |
| (134,109,750 | ) | |
| 34 | | |
| - | | |
| 1,564,217 | | |
| - | | |
| 1,564,251 | |
| Warrants issued with notes payable | |
| - | | |
| - | | |
| - | | |
| - | | |
| 9,533 | | |
| - | | |
| 9,533 | |
| Warrants issued for services | |
| - | | |
| - | | |
| - | | |
| - | | |
| 343,902 | | |
| - | | |
| 343,902 | |
| Common shares issued for cash | |
| 35,904 | | |
| - | | |
| 4 | | |
| - | | |
| 1,024,966 | | |
| - | | |
| 1,025,000 | |
| Common shares issued to settle payable | |
| 937 | | |
| - | | |
| - | | |
| - | | |
| 11,249 | | |
| - | | |
| 11,249 | |
| Common shares issued for services | |
| 21,288 | | |
| - | | |
| 2 | | |
| - | | |
| 518,175 | | |
| - | | |
| 518,177 | |
| Common shares issued to settle debt | |
| 32,344 | | |
| - | | |
| 3 | | |
| - | | |
| 836,247 | | |
| - | | |
| 836,250 | |
| Common shares issued for warrant exercise | |
| 26,250 | | |
| - | | |
| 3 | | |
| - | | |
| 524,997 | | |
| - | | |
| 525,000 | |
| Shares issued to settle liability issue shares | |
| 2,500 | | |
| - | | |
| - | | |
| - | | |
| 7,400 | | |
| - | | |
| 7,400 | |
| Option issued for services | |
| - | | |
| - | | |
| - | | |
| - | | |
| 218,454 | | |
| - | | |
| 218,454 | |
| Deemed dividend | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (12,521,190 | ) | |
| (12,521,190 | ) |
| Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,404,418 | ) | |
| (4,404,418 | ) |
| Balance, September 30, 2021 | |
| 1,361,980 | | |
| 30,081,000 | | |
$ | 136 | | |
$ | 8 | | |
$ | 8,637,029 | | |
$ | (25,025,235 | ) | |
$ | (16,388,032 | ) |
Series
C Preferred Stock amounts reflected in mezzanine equity
The
accompanying notes are an integral part of the unaudited condensed financial statements
Curative
Biotechnology, Inc
Condensed
Statements of Cash Flows
(Unaudited)
Nine
months ended September 30,
The
accompanying notes are an integral part of the unaudited condensed financial statements
Curative
Biotechnology, Inc
Notes
to Condensed Financial Statements
(Unaudited)
NOTE
1 - NATURE OF OPERATIONS
Curative
Biotechnology Inc. (f/k/a Connectyx Technologies Holdings Group, Inc.), (CUBT), is a Florida corporation, formed as a Nevada corporation
on June 29, 1995, reincorporated in Florida on October 30, 2007, with a name change November 30, 2020, which conducts business from its
headquarters in Boca Raton, Florida. Curative Biotechnology, Inc. is a development stage biomedical company that seeks to develop, in-license,
sub-license and bring to market products in both the Pharmaceutical and Medical Device space. The Company focuses on products that are
targeted at FDA-defined “Orphan Diseases” with patient populations under 200,000 in the United States. The company leverages
management’s experience and business relationships with Life Science research institutions as well as Life Science industry members
to acquire Life Science candidates that fit within the company’s business model. The company has established a scientific advisory
board with a successful track record of bringing pharmaceuticals to market.
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES
(a)
Basis of Presentation The accompanying condensed interim financial statements have been prepared without audit in accordance with
Generally Accepted Accounting Principles (“GAAP”) in the United States of America (“U.S.”) as promulgated by
the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”). In our opinion,
the accompanying unaudited interim financial statements contain all adjustments (which are of a normal recurring nature) necessary for
a fair presentation. Operating results for the nine months ended September 30, 2022 are not necessarily indicative of the results that
may be expected for the year ending December 31, 2022. Certain comparative period items have been reclassified to conform with the current
period presentation.
On
September 26, 2022, the Company effected a 1-for-400 reverse stock split of its common stock and adjusted
the ratio at which the Company’s preferred stock is convertible into common. This also impacts the number of stock options and
warrants and their respective exercise prices. All common shares, stock options, warrants, and per share information presented in the
accompanying condensed financial statements and notes have been adjusted, where applicable, to reflect the reverse split on a retroactive
basis for all periods presented. There was no change in the par value of the Company’s common stock
(b)
Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United
States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from these estimates.
(c)
Cash and equivalents For purposes of the statement of cash flows, the Company considers all highly liquid investments with maturity
of three months or less when purchased to be cash equivalents. The Company had no cash equivalents at September 30, 2022 and December
31, 2021.
(d)
Prepaid expenses From time to time, the Company may prepay expenses either through the transfer of cash, assets or the issuance of
securities. Prepaid expenses are amortized over the period of benefit.
(e)
Property and equipment All property and equipment are recorded at cost and depreciated over their estimated useful lives, using the
straight-line method. Upon sale or retirement, the cost and related accumulated depreciation are eliminated from their respective accounts,
and the resulting gain or loss is included in the results of operations. Repairs and maintenance charges, which do not increase the useful
lives of the assets, are charged to operations as incurred.
Curative
Biotechnology, Inc
Notes
to Condensed Financial Statements
(Unaudited)
(f)
Intangible Assets The useful life of intangible assets is assessed as either finite or indefinite. Following the initial recognition,
intangible assets are carried at cost less any accumulated amortization and accumulated impairment losses, if any.
Intangible
assets with finite useful lives are carried at cost less accumulated amortization. Amortization is calculated using the straight-line
method over the estimated useful lives.
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES, continued
Intangible
assets with indefinite useful lives are not amortized, but are tested for impairment annually. The assessment of indefinite life is reviewed
annually to determine whether the indefinite life continues to be supportable. If not, the change in useful life from indefinite to finite
is made on a prospective basis. If impairment indicators are present, these assets are subject to an impairment review. Any loss resulting
from impairment of intangible assets is expensed in the period the impairment is identified.
(g)
Impairment of Long-Lived Assets A long-lived asset is tested for impairment whenever events or changes in circumstances indicate
that its carrying value amount may not be recoverable. An impairment loss is recognized when the carrying amount of the asset exceeds
the sum of the undiscounted cash flows resulting from its use and eventual disposition. The impairment loss is measured as the amount
by which the carrying amount of the long-lived assets exceeds its fair value.
(h)
Financial Instruments and Fair Value Measurements ASC 825-10 “Financial Instruments”, allows entities to voluntarily
choose to measure certain financial assets and liabilities at fair value (fair value option). The fair value option may be elected on
an instrument-by-instrument basis and is irrevocable, unless a new election date occurs. If the fair value option is elected for an instrument,
unrealized gains and losses for that instrument should be reported in earnings at each subsequent reporting date. The Company did not
elect to apply the fair value option to any outstanding instruments.
ASC
825 also requires disclosures of the fair value of financial instruments. The carrying value of the Company’s current financial
instruments, which include cash and cash equivalents, accounts payable and accrued liabilities approximates their fair values because
of the short-term maturities of these instruments.
FASB
ASC 820 “Fair Value Measurement” clarifies that fair value is an exit price, representing the amount that would be received
to sell an asset or paid to transfer a liability in an orderly transaction between market participants. It also requires disclosure about
how fair value is determined for assets and liabilities and establishes a hierarchy for which these assets and liabilities must be grouped,
based on significant levels of inputs as follows:
Level
1: Quoted prices in active markets for identical assets or liabilities.
Level
2: Quoted prices in active markets for similar assets and liabilities and inputs that are observable for the asset or liability.
Level
3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
The
determination of where assets and liabilities fall within this hierarchy is based upon the lowest level of input that is significant
to the fair value measurement.
(i)
Related Party Transactions All transactions with related parties are in the normal course of operations and are measured at the exchange
amount.
Curative
Biotechnology, Inc
Notes
to Condensed Financial Statements
(Unaudited)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES, continued
(j)
Revenue Recognition The Company adopted Accounting Standards Codification, (“ASC”), 606, “Revenue from Contracts
with Customer” on January 1, 2018. This revenue recognition standard has a five step process: a) Determine whether a contract exists;
b) Identify the performance obligations; c) Determine the transaction price; d) Allocate the transaction price; e) Recognize revenue
when (or as) performance obligations are satisfied. The Company’s financial statements are prepared under the accrual method of
accounting. Revenues will be recognized when pervasive evidence of an arrangement exists, services have been rendered (product delivered),
the sales price is fixed or determinable, and collectability is reasonably assured. This occurs only when the product(s) is ordered and
subsequently delivered.
(k)
Stock based compensation Stock-based compensation is accounted for based on the requirements of the Share-Based Payment Topic of
ASC 718 which requires recognition in the consolidated financial statements of the cost of employee and director services received in
exchange for an award of equity instruments over the period the employee or director is required to perform the services in exchange
for the award. The ASC also requires measurement of the cost of employee and director services received in exchange for an award based
on the grant-date fair value of the award. Pursuant to ASC 505-50, for share-based payments to non-employees, compensation expense is
determined at the “measurement date.” The expense is recognized over the service period of the award. Until the measurement
date is reached, the total amount of compensation expense remains uncertain. The Company initially records compensation expense based
on the fair value of the award at the measurement date.
(l)
Income Taxes Provisions for income taxes are based on taxes payable or refundable for the current year and deferred taxes on temporary
differences between the amount of taxable income and pretax financial income, and between the tax bases of assets and liabilities and
their reported amounts in the financial statements. Deferred tax assets and liabilities are included in the consolidated financial statements
at currently enacted income tax rates applicable to the period in which the deferred tax assets and liabilities are expected to be realized
or settled as prescribed in FASB ASC 740. As changes in tax laws or rates are enacted, deferred tax assets and liabilities are adjusted
through the provision for income taxes. Tax positions initially need to be recognized in the financial statements when it is more-likely-than-not
the positions will be sustained upon examination by the tax authorities.
(m)
Net loss per share Basic loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding
during the period. Diluted loss per share reflects the potential dilution that could occur if securities or other contracts to issue
common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of
the Company. Diluted loss per share is computed by dividing the loss available to stockholders by the weighted average number of shares
outstanding for the period and dilutive potential shares outstanding unless consideration of such dilutive potential shares would result
in anti-dilution. There were no dilutive common stock equivalents for the periods ended September 30, 2022 and 2021.
NOTE
3 - LIQUIDITY AND GOING CONCERN CONSIDERATIONS
The
accompanying interim condensed financial statements have been prepared assuming that the Company will continue as a going concern. The
Company’s financial position and operating results raise substantial doubt about the Company’s ability to continue as a going
concern, as reflected by the net loss of approximately $4.1 million for the nine months ended September 30, 2022, accumulated deficit
of approximately $31.0 million as of September 30, 2022 and a deficiency in working capital of approximately $3.0 million at September
30, 2022. The ability of the Company to continue as a going concern is dependent upon commencing operations, developing sales and obtaining
additional capital and financing. The financial statements do not include any adjustments that might be necessary if the Company is unable
to continue as a going concern. The Company is currently seeking additional capital to allow it to grow its operations
Curative
Biotechnology, Inc
Notes
to Condensed Financial Statements
(Unaudited)
NOTE
4 - INTANGIBLE ASSETS
During
the 4th quarter 2021, the Company acquired the following intangible asset:
(a)
MABT Covid-19 license The Company entered into a licensing agreement with Mid-Atlantic BioTheraputics, Inc., (MABT), to license MABT’s
COVID-19 vaccine which is composed of a recombinant S1 and S2 protein from SARS-CoV-2 plus an IMT504 adjuvant. The Company issued 31,250
shares of common stock valued at $1,425,000 to acquire this license.
During
the 4th quarter 2020, the Company acquired the following intangible assets:
(b)
Website In December 2020, the Company contracted with a third party to develop and produce a new website for the Company for a contract
price of $22,500, one-half in cash and one-half in common stock of the Company. The Company is amortizing this cost over 3 years. This
website was placed into service in March 2021. Amortization expense for the nine months ended September 30, 2022 was $5,625.
(c)
Patent rights option In October 2020, the Company entered into an agreement for the option to purchase certain exclusive license
rights for US Patent No. 8,287,505 Ophthalmic Drop Dispensing Tip Assembly, issued October 16, 2012, from IEM, Inc., (IEM), the sole
owner of this patent. The cost of this option was $1,800.
The
Company had until September 30, 2021, to advise IEM in writing that it wishes to exercise this Option Right and pay IEM $50,000 in exchange
for an exclusive world-wide, royalty free perpetual license. In September 2021, the Company exercised the option to extend the deadline
for notification in the contract with IEM, from September 30, 2020 to March 31, 2022, in exchange for the payment of $1,000. In April
2022 the Company paid $1,000 for an additional six month extension. The Company is evaluating the Patent rights, potential products and
markets under this Patent.
(d)
IMT504 Patent license In October 2020, the Company entered into a license agreement with MidAtlantic BioTheraputics, Inc., (MABT),
to license the development of a pharmaceutical compound known as IMT504, as immununotherapy for late stage symptomatic rabies. The license
is for worldwide use. There are certain conditions to the license, principally that the Company raise $6.5 million to fund the development.
There is not a time limit on raising these funds unless the Company utilizes a public offering process, such as Regulation A.
The
total cost for this license is 50,000 shares of the Company’s common stock, issuable in three tranches - (1) 17,500 shares upon
execution of the license (which have been issued, valued at $91,000), (2) 16,250 shares upon the submission of an Investigational New
Drug (IND) to the FDA and (3) 16,250 shares upon the successful completion of the first rabies clinical trial of this IND. This license
calls for royalties of 50% of the net profit, after reimbursement for development costs, of successfully marketed products utilizing
IMT504.
A
principal goal of this license is to obtain a Priority Review Voucher (PRV) issued by the US FDA, and subsequently sell the PRV to a
major pharmaceutical company. The Company and MABT will split the proceeds from the sale of such PRV equally.
(e)
National Institute of Health (NIH) Patent license #1 In October 2020, the Company entered into an exclusive 24 month evaluation license
of Provisional Patent Application No. 62/199,707, filed July 31, 2015; PCT Application No. PCT/US2016/044777 filed July 29, 2016 and
Patent No. 10,548,987 issued February 4, 2020. This license is for the evaluation of and development of an anti-CD56 antibody drug conjugate
for the treatment of glioblastoma. Should the Company develop a marketable product, the Company is then required to negotiate a new license
with market based royalties.
Curative
Biotechnology, Inc
Notes
to Condensed Financial Statements
(Unaudited)
NOTE
4 - INTANGIBLE ASSETS, continued
This
license calls for the payment of a non-creditable non-refundable license issue royalty of $10,000, paid ½ at issuance and ½
on the one year anniversary.
(f)
National Institute of Health (NIH) Patent license #2 In January 2021 the Company entered into an NIH exclusive 36 month worldwide
license of Provisional Patent Application No. 62/899,899, filed September 13, 2019 and PCT Application No. PCT/US2020/050540 filed September
11, 2020. This license is for the development of ocular metformin formulation for the treatment of retinal degenerative diseases.
This
license requires two separate royalty streams of payments.
First
is a royalty equal to the unreimbursed patent expenses paid by NIH, with an initial amount of $8,500 due within 30 days of execution
of the license. At the first anniversary of the license NIH will supply a statement of additional unreimbursed patent expenses paid by
NIH during the year, of which the Company is required to pay 50%, with the remaining balance due on the third anniversary.
(f)
National Institute of Health (NIH) Patent license #2, continued
Second
is an ongoing royalty schedule: an initial royalty of $5,000 upon execution of the license, and annually thereafter as the minimum royalty
amount. The license can be extended on the third anniversary to the remaining life of the licensed patent by the payment of a one-time
non-refundable non-creditable royalty of $45,000. There are three benchmark royalties - $75,000 upon the initiation of the first Phase
2 Clinical Study; $300,000 upon the completion of Phase 3 Clinical Study and $600,000 upon the FDA approval of the first Licensed Product.
Upon first commercial sale there is a royalty of $100,000 each for the United States, Canada, European Union and Asian region. Last is
a 3.5% of net sales royalty.
NOTE
5 - RELATED PARTY TRANSACTIONS
From
time to time the Company may enter into non-arms length transactions with related parties, however the Company exercises its best efforts
to ensure that such transactions are valued on a basis comparable to a true arms length transaction.
During
the second quarter of 2021, the remaining two notes from officers of the Company, totaling $40,000 of principal and $10,000 of OID, were
repaid in cash.
NOTE
6 - NOTES PAYABLE
During
the second quarter of 2022, the Company issued a promissory note in exchange for $200,000 in cash. This note carries a 12% interest rate,
interest payable monthly, and a six month maturity.
During
the quarter ended March 31, 2022, the Company entered into a financing for the purchase of a Directors and Officers (D&O) Liability
Insurance policy. This financing carries a 5.65% interest rate and is payable monthly for 10 months. At September 30, 2022, the outstanding
balance on this note was zero.
During
the second quarter of 2021, the then remaining two notes, totaling $40,000 of principal and $10,000 of OID, were repaid in cash.
During
the first quarter of 2021, 13 of the 15 note holders converted their note receivable into shares of common stock at the rate of $24.00
per share, for a total of 27,343 shares of common stock for a total of $656,250 convertible debt.
Curative
Biotechnology, Inc
Notes
to Condensed Financial Statements
(Unaudited)
NOTE
7 - CONVERTIBLE SENIOR SECURED NOTE PAYABLE
During
the first quarter of 2021, the Company entered into 2 notes payable for a total amount of cash received of $110,000. The notes are identical
and carry a maturity of six months from inception and a 25% original issue discount (OID). The maturity was extendable at the Company’s
option for up to three months with a 3% per month extension fee. The notes also carried 10 warrants for each $1 loaned. These notes were
collateralized by Preferred C shares representing 2.64% of the issued and outstanding common stock shares. Two officers holding Preferred
C shares have pledged the Preferred C shares as this collateral.
In
March 2022, the Company issued a 12-month Senior Secured Note with a face amount of $1,142,857, with a stated 12.5% original issue discount
(OID). The Note carries a 12.5% interest rate with interest-only payable monthly from April through August 2022. The Company received
$869,972 in cash, net of the OID of $142,857 and legal and other fees in the amount of $125,714.
Beginning
in September 2022, the Company was required to make monthly redemptions at the rate of 110% of one seventh of the original principal amount,
($179,592), plus interest. It also carries a mandatory prepayment at 125% of the original principal amount, or $1,428,571, less any redemptions
made, upon the completion of a Qualified Offering, as defined. See August 2022 amendment described below and Subsequent Events note.
The
Note is convertible into common stock of the Company upon an event of default, as defined.
The
lender received five year warrants to purchase 57,142 shares of common stock of the Company, with an exercise price of $0.0001 per share.
These warrants were recorded as debt discount in the amount of $0.9 million which is being amortized over the term of the Note. The warrants
can be exercised on a cash-less basis given a registration statement for the common shares underlying the warrants was not declared effective
by September 2022.
The
Note is secured by all the tangible and intangible assets of the Company.
In
August 2022, the Company and the lender agreed to a modification of the Note. In exchange for a one month extension to begin the principal
payments under this Note, the parties agreed to reduce the qualified offering amount from $10 million to $7.2 million; modify the payment
schedule from seven (7) months to six (6) months. In addition, the lender received 4,761 additional warrants having a fair value of $58,884,
which will be recorded as an additional debt discount and amortized over the remaining life of the Note.
Subsequent
to September 30, 2022, certain of the terms of the Note were modified. See Subsequent Events.
NOTE
8 – DEFICIENCY IN STOCKHOLDERS EQUITY
At
September 30, 2022 and December 31, 2021, the Company has 1,100,000,000 shares of par value $0.0001 common stock authorized and 1,429,129
and 1,426,629 issued and outstanding, respectively. At September 30, 2022 and December 31, 2021, the Company has 200,000,000 shares of
$0.0001 par value preferred stock authorized.
Curative
Biotechnology, Inc.
Notes
to Condensed Financial Statements
(Unaudited)
NOTE
8 – DEFICIENCY IN STOCKHOLDERS EQUITY, continued
The
Series A and Series C preferred stock has been accounted for in accordance with FASB Accounting Standards Codification (ASC) 480, as
mezzanine equity due to Series A having a redemption provision by the holder and Series C being convertible into a variable number of
common shares.
SCHEDULE
OF STOCKHOLDERS EQUITY
| | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | |
| | |
Series A | | |
Series B | | |
Series C | | |
Total | |
| | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | | |
No. Shares | | |
Par | |
| January 1, 2021 | |
| 134,109,750 | | |
$ | 13,411 | | |
| 293,000 | | |
$ | 29 | | |
| 30,000,000 | | |
$ | 3,000 | | |
| 164,402,750 | | |
$ | 16,440 | |
| Conversion to common shares | |
| (134,109,750 | ) | |
| (13,411 | ) | |
| (212,000 | ) | |
| (21 | ) | |
| - | | |
| - | | |
| (134,321,750 | ) | |
| (13,432 | ) |
| December 31, 2021 | |
| - | | |
| - | | |
| 81,000 | | |
| 8 | | |
| 30,000,000 | | |
$ | 3,000 | | |
| 30,081,000 | | |
| 3,008 | |
| Beginning balance, value | |
| - | | |
| - | | |
| 81,000 | | |
| 8 | | |
| 30,000,000 | | |
$ | 3,000 | | |
| 30,081,000 | | |
| 3,008 | |
| no transactions | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| September 30, 2022 | |
| - | | |
$ | - | | |
| 81,000 | | |
$ | 8 | | |
| 30,000,000 | | |
$ | 3,000 | | |
| 30,081,000 | | |
$ | 3,008 | |
| Ending balance, value | |
| - | | |
$ | - | | |
| 81,000 | | |
$ | 8 | | |
| 30,000,000 | | |
$ | 3,000 | | |
| 30,081,000 | | |
$ | 3,008 | |
The
preferred shares have the following respective rights and privileges:
Series
A Preferred carry 10 votes for each share of common stock that each Series A shares are convertible into at the record date; is convertible
into common stock aggregating 35% of the total issued and outstanding common shares at conversion date post conversion; are redeemable
for the greater of 45% of the total market value of the common share or the calculation of the book value of the Company made by an independent
audit firm or $5,000,000. During the first quarter of 2021, all of the Series A was converted into 339,591 shares of common stock.
Series
B Preferred are convertible in common shares of common stock at a conversion price of $3.00 per share; are redeemable at a price of 125%
of the purchase price paid for the shares; carry one vote for each common share that the Series B is convertible into at the record date;
are senior to all other securities in the event of a liquidation. During the first quarter of 2021, 203,000 shares of the Series B was
converted into 67,666 shares of common stock.
Series
C Preferred are convertible into at the record date; is convertible into common stock aggregating 30% of the total issued and outstanding
common shares at conversion date post conversion; carry one vote for each common share that the Series C is convertible into at the record
date.
Quarter
ended March 31, 2022: The Company issued 2,500 shares of common stock to one employee for past services valued at $51,750.
Quarter
ended December 31, 2021: The Company issued 32,898 shares of common stock and 64,788 warrants for the purchase of common stock in exchange
for $523,000 in cash and $25,000 in deposit in transit. The Company issued 500 shares of common stock, valued at $21,960 for services.
The Company issued 31,250 shares of common stock, valued at $1,425,000 for the license to MABT’s COVID-19 vaccine.
Quarter
ended September 30, 2021: The Company issued 10,902 shares of common stock and 10,590 warrants for the purchase of common stock in exchange
for $425,000 in cash. The Company issued 625 shares of common stock, valued at $22,500, to an individual for services to be rendered
as a member of the Company’s Advisory Board. These shares vest 150 immediately, 150 in December 2021, 150 in April 2022 and 175
in August 2022. The Company issued 750 shares of common stock, valued at $36,720, to an individual for services rendered as a member
of the Company’s Board of Directors. The Company issued 625 shares of common stock, valued at $28,475, to an individual for services
to be rendered as a member of the Company’s Advisory Board. These shares vested immediately. The Company issued 5,000 shares of
common stock, valued at $180,000, to settle the lawsuit brought to enforce the convertible note. 9,000 shares of the Series B preferred
stock was converted into 3,000 shares of common stock.
Curative
Biotechnology, Inc.
Notes
to Condensed Financial Statements
(Unaudited)
NOTE
8 – DEFICIENCY IN STOCKHOLDERS EQUITY, continued
Quarter
ended June 30, 2021: The Company issued 25,000 shares of common stock and 12,500 warrants for the purchase of common stock in exchange
for $600,000 in cash. The warrants mature in May 2026, and carry an exercise price of $44.00 per share. The Company issued 2,500 shares
of common stock to settle the liability to issue shares.
Quarter
ended March 31, 2021: The Company issued 312 shares of common stock in exchange for services valued at $5,575, or $17.84 per share. The
Company issued 937 shares of common stock to settle a payable in the amount of $11,250. All of the Series A preferred stock was converted
into 339,591 shares of common stock. 203,000 shares of the Series B preferred stock was converted into 67,666 shares of common stock.
13 of the 15 note holders converted their note receivable into shares of common stock at the rate of $24.00 per share, for a total of
27,343 shares of common stock for a total of $656,250 convertible debt. The Company issued 26,250 shares of common stock upon receipt
of $525,000 in cash for the exercise of 26,250 warrants. The Company issued 16,250 shares of common stock for the exercise of 16,250
warrants in exchange for services valued at $325,000.
NOTE
9 - WARRANTS
Quarter
ended March 31, 2022: The lender of the Convertible Senior Secured Note received five year warrants to purchase 57,142 shares of common
stock of the Company, with an exercise price of $0.0001 per share. These warrants were recorded as debt discount in the amount of $0.9
million which will be amortized over the term of the Note. The warrants can be exercised on a cash-less basis given a registration statement
for the common shares underlying the warrants was not declared effective by September 2022.
Quarter ended September 30, 2022: In August 2022, the Company and the lender agreed to a modification of the Note described in previous
paragraph, which resulted in the lender receiving 4,761 additional warrants.
Quarter
ended December 31, 2021: The Company issued 1,008 warrants for the purchase of common stock of the Company in conjunction with the sale
of 1,008 shares of common stock for cash. These warrants expire in December 2024 and have an exercise price of $44.00 per share. The
Company issued 63,780 warrants for the purchase of common stock of the Company in conjunction with the sale of 31,890 shares of common
stock for cash and subscription receivable. These warrants expire in December 2024 and have an exercise price of $36.00 and $60.00 per
share.
Quarter
ended September 30, 2021: The Company issued 10,590 warrants for the purchase of common stock of the Company in conjunction with the
sale of 10,902 shares of common stock for cash. These warrants expire in July and August 2026 and have an exercise price of $60.00 and
$56.00 per share. The Company issued 2,500 warrants for the purchase of common stock of the Company in exchange for services as a member
of the Board of Directors. These warrants expire in July 2024 and have an exercise price of $49.60 per share and have a cash-less exercise
provision. These warrants were recorded at a total value of $34,382.
Quarter
ended June 30, 2021: The Company issued 12,500 warrants for the purchase of common stock of the Company in conjunction with the sale
of 25,000 shares of common stock for cash. These warrants expire in May 2026 and have an exercise price of $44.00 per share. The Company
issued 12,500 warrants for the purchase of common stock of the Company in exchange for services as a member of the Board of Directors.
These warrants expire in June 2024 and have an exercise price of $80.00 per share. The warrants were recorded at a total value of $87,249.
The Company issued 7,500 warrants for the purchase of common stock of the Company in exchange for legal services. These warrants expire
in May 2026 and have an exercise price of $40.00 per share. The warrants were recorded at a total value of $155,717. The Company issued
2,500 warrants for the purchase of common stock of the Company in exchange for services. These warrants expire in May 2026 and have an
exercise price of $40.00 per share. The warrants were recorded at a total value of $51,906 and vest 625 shares on May 20, 2021 and September
20, 2021, January 20, 2022 and May 20, 2022.
Curative
Biotechnology, Inc
Notes
to Condensed Financial Statements
(Unaudited)
NOTE
9 – WARRANTS, continued
Quarter
ended March 31, 2021: The Company issued 26,250 shares of common stock upon receipt of $525,000 in cash for the exercise of 26,250 warrants.
The Company issued 16,250 shares of common stock in exchange for services valued at $325,000 for the exercise of 16,250 warrants. The
Company issued 2,750 warrants for the purchase of common stock of the Company in conjunction with the short term debt at the rate of
2.5 warrants for each $100 loaned. These warrants carry an expiration of thirty six months from issuance; an exercise price of $20.00
per share and are exercisable immediately. The warrants were recorded at a total value of $9,533. The Company issued 12,500 warrants
for services. These warrants carry an expiration of 60 months from issuance and an exercise price of $20.00 per share. The warrants were
recorded at a total value of $40,600.
The
method utilized to value the warrants was the Black-Scholes model with the following assumption ranges: Expected life - three or five
years; stock price between $16.00 and $40.00; volatility between 60.51 and 31.56; exercise price between $0.0001 and $80.00 and bond
equivalent yield rate between 0.09% and 0.83%.
NOTE
10 - OPTIONS
Quarter
ended March 31, 2022: The Company issued 18,641 options to purchase shares of common stock equally to three employees for past services,
valued at $155,250. These options have an exercise price of $20.70 and a five year life.
Quarter
ended September 30, 2021: The Company issued options in conjunction with an agreement for Board of Advisor services and the
evaluation of certain potential intangible asset acquisitions. These options call for an undivided 1%
of the fully diluted issued and outstanding shares upon exercise. These options amounted to 20,202
shares at issuance date. These option s contain a single recalculation upon the completion of a reverse split of the existing common
stock and the Company raising a minimum of $5
million in an offering. These options carry an exercise price of $44.00
per share and expire in September 2031. These options were valued at $436,908
and vest 50%
upon issuance and 50%
in September 2022. As a result, the Company recognized approximately $218,000 of compensation expense related to these options during
the three and nine months ended September 30, 2022.
The
method utilized to value the options was the Black-Scholes model with the following assumption ranges: Expected life - ten years; stock
price $45.60; volatility 35.13; exercise price $44.00 and bond equivalent yield rate 1.47%.
NOTE
11 - EQUITY INCENTIVE PLAN
On
August 26, 2021, the Company adopted a equity incentive plan providing for the issuance of shares of common stock, options or SARs with
a rolling maximum number equal to 10% of the issued and outstanding Common Shares set at the beginning of each fiscal year. The Company
may grant incentives to its directors, officers, employees and service providers. The options are exercisable for a maximum of up to
ten years from the date of grant and may be subject to vesting provisions as set by the Plan Administrator.
During
the quarter ended March 31, 2022, a total of 2,500 shares of common stock and 18,641 options at a weighted-average exercise price of
$20.70 per share were granted to employees exercisable for a period of five years with immediate vesting. The weighted-average fair value
attributable to options granted in 2022 was $8.32.
The
fair value of the stock options recognized in the period has been estimated using the Black-Scholes option pricing model.
Curative
Biotechnology, Inc
Notes
to Condensed Financial Statements
(Unaudited)
Assumptions
used in the pricing model are as provided below.
SCHEDULE
OF FAIR VALUE OF STOCK OPTION ASSUMPTIONS
| Risk-free interest rate | |
| 1.55 | % |
| Exercise price | |
$ | 20.70 | |
| Expected life | |
| 5 years | |
| Expected volatility | |
| 44.12 | % |
| Expected dividends | |
| - | |
The
Company recognized equity incentive expense of approximately $207,000 for the nine months ended September 30, 2022.
As
of September 30, 2022, there were 18,641 fully vested options outstanding with a weighted average exercise price of $20.70 per share.
There were no non-vested options outstanding.
A
summary of the Company’s stock option plan and changes during the nine months ended September 30, 2022 is as follows:
SCHEDULE
OF STOCK OPTION ACTIVITY
| | |
Number of options | | |
Weighted average exercise price | |
| Balance - beginning of the year | |
| - | | |
$ | - | |
| Granted | |
| 18,641 | | |
| 20.70 | |
| Exercised | |
| - | | |
| - | |
| Cancelled | |
| - | | |
| - | |
| Balance - end of period | |
| 18,641 | | |
$ | 20.70 | |
The
aggregate intrinsic value of vested share options (the market value less the exercise price) at September 30, 2022 was zero.
NOTE
12 - FINANCIAL INSTRUMENTS
(a)
Liquidity Risk Liquidity risk is the risk that the Company will not be able to meet its obligations associated with financial liabilities.
The Company relies on cash flows generated from operations, as well as injections of capital through the issuance of the Company’s
capital stock to settle its liabilities when they become due.
(b)
Interest Rate Risk The Company is not exposed to significant interest rate risk due to the short-term maturity of its monetary assets
and liabilities.
Curative
Biotechnology, Inc
Notes
to Condensed Financial Statements
(Unaudited)
NOTE
13 - IMPAIRMENT OF LONG LIVED ASSETS
In
the fourth quarter 2021 the Company determined that its fixed assets were obsolete and wrote off the undepreciated balance of $1,958.
In
March 2021, when the Company’s new website was placed in service, the remaining unamortized cost of the Company’s legacy
website was written off, for a total charge of $15,000.
NOTE
14 - COMMITMENTS AND CONTINGENCIES
(a)
Other The Company is subject to asserted claims and liabilities that arise in the ordinary course of business. The Company maintains
insurance policies to mitigate potential losses from these actions. In the opinion of management, the amount of the ultimate liability
with respect to those actions will not materially affect the Company’s financial position or results of operations.
NOTE
15 - CONCENTRATIONS OF CREDIT RISK
(a)
Cash The Company maintains its cash in bank deposit accounts, which may, at times, may exceed federally insured limits. The Company
had zero and $416,178 cash balance in excess of FDIC insured limits at September 30, 2022 and December 31, 2021, respectively.
NOTE
16 - COVID-19 PANDEMIC AND VARIANTS
The
full extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and financial condition,
will depend on future developments that are uncertain, including as a result of new information that may emerge concerning COVID-19 and
the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international customers
and markets. We have made estimates of the impact of COVID-19 within our financial statements, and although there is currently no major
impact, there may be changes to those estimates in future periods.
NOTE
17 - SUBSEQUENT EVENTS
(a)
Convertible Senior Secured Note Payable and Warrants On October 14, 2022, the parties to this convertible note agreed to an amendment
of the Note. As a result of the amendment, the first principal repayment was amended to be due on November 2, 2022, instead of October
2, 2022. The Company also amended the warrant to increase the number of shares of common stock underlying the warrant by another 4,761
(resulting in total shares underlying the warrant of 66,666), and each principal payment is increased from 1/6 of the outstanding note
principal balance to 1/5 of the outstanding note principal balance. The additional warrants had a fair value of approximately $60,000,
which will be recorded as an additional debt discount and amortized over the remaining life of the Note.
On November 16, 2022, the
parties to this convertible note agreed to another amendment, which further delayed the first principal payment until December 17, 2022.
The
Company also amended the warrant to increase the number of shares of common stock underlying the warrant by another 4,762
(resulting
in total shares underlying the warrant of 71,428)
and each principal payment is increased from 1/5 of the outstanding note principal balance to 1/4 of the outstanding principal
amount.
On December 16, 2022, the
parties to this convertible note agreed to another amendment, which further delayed the first principal payment until January 17, 2023.
The
Company also amended the warrant to increase the number of shares of common stock underlying the warrant by another 4,762
(resulting in total shares underlying the warrant of 76,190)
and each principal payment is increased from 1/4 of the outstanding note principal balance to 1/3 of the outstanding principal
amount.
On January 11, 2023, the parties to this convertible
note agreed to another amendment, which further delayed the first principal payment until January 31, 2023. The Company also amended
the Note to increase each principal payment from 1/3 of the outstanding note principal balance to 1/2 of the outstanding principal
amount. In connection with the amendment the Company agreed to pay the lender $5,000 of the unpaid interest due on the Note.
In
December 2022, the Company sold 146,000
shares of Series B Preferred Stock for $146,000
and issued 19,048
shares of common stock upon the exercise of warrants,
which resulted in $152,390
of cash proceeds.
1,333,333 Units With Each Unit Consisting
of:
One Share of Common Stock
One Warrant to Purchase One Share of Common
Stock
,
2023
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
13. Other Expenses of Issuance and Distribution.
The
following table sets forth the estimated costs and expenses in connection with the sale and distribution of the securities being registered,
other than placement agent fees. All expenses incurred will be paid by the Company. All of the amounts shown are estimates other than
the Securities and Exchange Commission, or SEC, registration fees.
| |
|
|
To be Paid by the
Registrant |
|
| SEC registration fees |
|
$ |
2,587.87 |
|
| FINRA Filing Fee |
|
$ |
5,000 |
|
| NYSE Listing Fee |
|
$ |
50,000 |
|
| Legal fees and expenses |
|
$ |
314,000 |
|
| Accounting fees and expenses |
|
$ |
114,000 |
|
| Printing and engraving expenses |
|
$ |
5,000 |
|
| Transfer agent’s fees |
|
$ |
10,000 |
|
| Blue Sky fees and expenses |
|
$ |
3,000 |
|
| Miscellaneous fees and expenses |
|
$ |
12,248 |
|
| Total |
|
$ |
515,835.87 |
|
Item
14. Indemnification of Directors and Officers.
Florida
law permits, under certain circumstances, the indemnification of any person with respect to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative, to which such person was or is a party or is threatened
to be made a party, by reason of his or her being an officer, director, employee or agent of the corporation or is or was serving at
the request of such corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or
other enterprise, against liability incurred in connection with such proceeding, including appeals thereof; provided, however, that the
officer, director, employee or agent acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed
to, the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe
his or her conduct was unlawful. The termination of any such third-party action by judgment, order, settlement, or conviction or upon
a plea of nolo contendere or its equivalent does not, of itself, create a presumption that the person (i) did not act in good faith and
in a manner which he or she reasonably believed to be in, or not opposed to, the best interests of the corporation or (ii) with respect
to any criminal action or proceeding, had reasonable cause to believe that his or her conduct was unlawful. In the case of proceedings
by or in the right of the corporation, Florida law permits indemnification of any person by reason of the fact that such person is or
was a director, officer, employee or agent of the corporation or is or was serving at the request of such corporation as a director,
officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against liability incurred
in connection with such proceeding, including appeals thereof; provided, however, that the officer, director, employee or agent acted
in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, the best interests of the corporation,
except that no indemnification is made where such person is adjudged liable, unless a court of competent jurisdiction determines that,
despite the adjudication of liability but in view of all circumstances of the case, such person is fairly and reasonably entitled to
indemnity for such expenses which such court shall deem proper.
To
the extent that such person is successful on the merits or otherwise in defending against any such proceeding, Florida law provides that
he or she shall be indemnified against expenses actually and reasonably incurred by him or her in connection therewith.
Also,
under Florida law, expenses incurred by an officer or director in defending a civil or criminal proceeding may be paid by the corporation
in advance of the final disposition of such proceeding upon receipt of an undertaking by or on behalf of such director or officer to
repay such amount if he or she is ultimately found not to be entitled to indemnification by the corporation pursuant to this section.
Expenses incurred by other employees and agents may be paid in advance upon such terms or conditions that the Board of Directors deems
appropriate.
Our
Bylaws provides that we shall indemnify our officers, directors, and employees, and agents unless specifically approved in writing by
the Board of Directors, to the fullest extent authorized by Section 607.0850 of the Florida Business Corporation Act, or the FBCA, as
it existed when the Bylaws were adopted or as it may hereafter be amended, but, in the case of any such amendment, only to the extent
that such amendment permits us to provide broader indemnification rights than were permitted prior to such amendment. Such indemnification
shall continue as to a person who has ceased to be a director, officer, employee, or agent; provided, however, that we shall indemnify
any such person seeking indemnity in connection with an action, suit, or proceeding (or part thereof) initiated by such person only if
such action, suit, or proceeding (or part thereof) was authorized by our Board of Directors.
The
Bylaws also provide that such rights of indemnification shall be a contract right and shall include the right to be paid by us for all
reasonable expenses incurred in defending any such proceeding in advance of final disposition; provided, however, that the payment of
such expenses incurred by a director or officer in his or her capacity as a director or officer in advance of the final disposition of
such proceeding shall be made only upon delivery to us of an undertaking, by or on behalf of such director or officer, to repay amounts
so advanced if it should be determined ultimately that such director or officer is not entitled to be indemnified under the Bylaws or
otherwise.
In
addition to the authority granted to us by Florida law to indemnify our directors, certain other provisions of the Florida Act have the
effect of further limiting the personal liability of our directors. Pursuant to Florida law, a director of a Florida corporation cannot
be held personally liable for monetary damages to the corporation or any other person for any act or failure to act regarding corporate
management or policy except in the case of certain qualifying breaches of the director’s duties.
As
a general policy, the Company anticipates entering into indemnification agreements with our officers and directors.
Insofar
as indemnification for liabilities arising under the Securities Act, as amended, may be permitted to our directors and officers, or to
persons controlling us, pursuant to our charter documents and Florida law, we have been informed that in the opinion of the Securities
and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933, as amended and is therefore
unenforceable.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers or persons controlling
the Company pursuant to the foregoing provisions, the Securities and Exchange Commission’s position is that such indemnification
is against public policy as expressed in the Securities Act of 1933 and is therefore unenforceable.
Item
15. Recent Sales of Unregistered Securities.
The
following information is given with regard to unregistered securities sold during the preceding three years including the dates and amounts
of securities sold, the persons or class of persons to whom we sold the securities, the consideration received in connection with such
sales and, if the securities were issued or sold other than for cash, the description of the transaction and the type and amount of consideration
received. The descriptions contained below are a summary and qualified by the agreements, if applicable, included as Exhibits to this
Registration Statement. The following securities were issued in private offerings pursuant to the exemption from registration contained
in Section 4(2) of the Securities Act of 1933, as amended, or the Securities Act and the rules promulgated thereunder.
| |
● |
On March 5, 2020, the Company issued a consultant 3,750 shares
of Common Stock for services. The shares were valued at $15,000. |
| |
|
|
| |
● |
On April 28, 2020, the Company issued a consultant 1,250 shares
of Common Stock for services. The shares were valued at $800. |
| |
|
|
| |
● |
On May 18, 2020, the Company issued consultants 1,250 shares
of Common Stock for services. The shares were valued at $15,000. |
| |
|
|
| |
● |
On May 18, 2020, the Company granted Richard Garr, our chief executive
officer, 625 shares of Common Stock valued at $7,500. |
| |
|
|
| |
● |
On October 8, 2020, the Company issued Mid-Atlantic Biotherapeutics,
Inc 17,500 shares of Common Stock pursuant to the licensing of certain assets on September 30, 2020. The shares were valued
at $91,000. |
| |
|
|
| |
● |
On November 8, 2020, the Company granted Michael Fish, our former director,
250 shares of restricted stock valued at $3,000. |
| |
|
|
| |
● |
On November 11, 2020, the Company issued 100,000,000 shares Series
A Preferred Stock in exchange for services to Paul Michaels and Barry Ginsberg, our president and Chief Strategy Officer, respectively.
Each person received 50,000,000 shares of Series A Preferred Stock valued at $775,420 each. The Series A Preferred Stock in the aggregate,
including other outstanding shares of which there were 34,109,750 already outstanding, was convertible at any time into 35% of the
issued and outstanding Common Stock post conversion. During the first quarter of 2021, all of the Series A Preferred Stockholders
(all of the Series A Preferred Stock consisted of 134,109,750) converted their shares into an aggregate of 339,591 shares
of Common Stock. |
| |
|
|
| |
● |
On November 11, 2020, the Company issued an aggregate of 30,000,000 shares of Series C Preferred Stock to certain employee and service providers of the Company. The Series C Preferred Stock is collectively convertible into such number of shares of Common Stock as will equal 30% of the issued and outstanding Common Stock post conversion. The Series C Preferred Stock votes 10 votes for every 1 share of Common Stock that the Series C Stock is convertible into. All 30,000,000 shares of Series C Preferred Stock are valued at an aggregate of $4,559,062. Of the 30,000,000 shares of Series C Preferred Stock issued, 6,000,000 were issued to each of (i) Paul Michaels, our Chairman and President, (ii) Barry Ginsberg, our Chief Strategy Officer and Director, and (iii) Richard Garr, our Chief Executive Officer, Chief Financial Officer, and General Counsel. |
| |
● |
Between November 18, 2020 and January 14, 2021, the Company sold an
aggregate of $525,000 in original issue discount promissory notes (the “Notes”) to third party investors. The Notes were
issued at a 25% original issue discount and accordingly, the Company was required to pay back an aggregate of $656,250 by the six
(6) month anniversary of each respective Note. The Company additionally had the right to extend the maturity dates of the Notes in
exchange for a 3% monthly penalty against the total amount payable under the respective Note. As additional consideration for the
Company extending the Notes, Paul Michaels and Barry Ginsberg agreed to pledge certain of their Series C Preferred Stock as collateral
for ensure the payment of the Notes. All of the Notes were exchanged for Common Stock pursuant to a Note Exchange Agreement at a
price of $24.00 per share on March 10, 2021 resulting in the issuance of 27,343 shares of Common Stock. Additionally,
on the dates that the respective Notes were issued, the Company issued each Note holder such number of warrants equal to ten (10)
shares for every dollar in cash loaned on the Note. As a result, the Company issued the Note holders an aggregate of 13,750
warrants to purchase Common Stock, having an exercise price of $20.00 per share, and a term of three (3) years from issuance.
All 13,750 warrants were exercised in the first quarter of 2021 for cash. |
| |
|
|
| |
● |
On December 3, 2020, the Company sold an additional $40,000 of Notes
to Paul Michaels and Barry Ginsberg ($20,000 each). The Company paid back $50,000 on the Notes, pursuant to their terms on June 3,
2021. Additionally, Mr. Michaels and Dr. Ginsberg were each issued warrants to purchase 500 shares of Common Stock with an
exercise price of $20.00 per share and a term of three (3) years. |
| |
|
|
| |
● |
On December 3, 2020, the Company issued a consultant (i) 625
shares of Common Stock and (ii) a warrant to purchase 625 shares of Common Stock, with an exercise price per share of $20.00
and a term of five (5) years. The Shares were valued at $7,500 and the warrant was valued at $1,635. |
| |
|
|
| |
● |
On December 9, 2020, the Company issued consultants an aggregate of
250 shares of Common Stock for services. The shares were valued at $3,000. |
| |
|
|
| |
● |
On January 14, 2021, the Company issued consultants an aggregate of
250 shares of Common Stock for services. The shares were valued at $4,400. |
| |
|
|
| |
● |
Between December 9, 2020 and January 14, 2021, the Company issued a
consultant warrants to purchase 28,750 shares of Common Stock with an exercise price of $20.00 and a term of five (5)
years (“Service Provider Warrants”). The Service Provider Warrants were valued at $83,100. |
| |
|
|
| |
● |
On January 25, 2021, the Company issued a consultant 1,000 shares
of Common Stock for services. The shares were valued at $12,425. |
| |
|
|
| |
● |
On February 10, 2021, the holder of the Service Provider Warrant exercised
12,500 shares at $20.00 per share for aggregate proceeds to the Company of $250,000. |
| |
|
|
| |
● |
On March 10, 2021, the Company issued the holder of the Service Provider
Warrant 16,250 shares of Common Stock in exchange for the cancellation of 16,250 shares underlying the Service Provider
Warrant described above and issued previously on January 14, 2021. The shares were valued at $325,000. |
| |
|
|
| |
● |
On April 26, 2021, the Company issued a consultant 625 shares
of Common Stock for services that vest (i) 150 shares at issuance, (ii) 150 shares on the 4 month anniversary of issuance,
(iii) 150 on the 8 month of issuance and (iv) 175 shares on the 1 year anniversary of issuance. The shares were valued
at $34,500. |
| |
|
|
| |
● |
On May 20, 2021, the Company issued a consultant a warrant to purchase
2,500 shares of Common Stock, with an exercise price of $40.00 per share and a term of five (5) years. The warrant
vests (i) 25% on May 20, 2020, (ii) 25% on September 20, 2021, (iii) 25% on January 20, 2022, and (iv) 25% on May 20, 2022. The warrant
was valued at $51,906. |
| |
|
|
| |
● |
On May 20, 2021, the Company issued a consultant a warrant to purchase
7,500 shares of Common Stock, with an exercise price of $40.00 per share and a term of five (5) years. The warrant
was valued at $155,717. |
| |
|
|
| |
● |
On May 21, 2021, the Company sold 25,000 units at a price per
unit of $24.00 or an aggregate of $600,000. Each unit consisted of (i) one (1) share of Common Stock and (ii) a warrant to
purchase one half (1/2) of one share of Common Stock. The warrants have an exercise price per share of $44.00 per share and
a term of five (5) years. As a result of the offering, the Company issued 25,000 shares of Common Stock and warrants to purchase
12,500 shares of Common Stock. |
| |
|
|
| |
● |
On June 11, 2021, the Board granted Paul Michaels, our president and
a director, warrants to purchase 12,500 shares of Common Stock. The exercise price of the warrant is $40.00 per share,
and the warrant has a term of 3 years from issuance. The warrant grant was valued at $87,249. |
| |
|
|
| |
● |
On June 11, 2021, the Company issued a consultant 2,500 shares
of Common Stock for services. The shares were valued at $7,400. |
| |
|
|
| |
● |
On June 23, 2021, the Company issued an employee 2,100 shares
of Common Stock with (i) 525 shares vested on the grant date, (ii) 525 shares vesting on September 28, 2021, (iii)
525 shares vesting on December 28, 2021, and (iv) 525 shares vesting on March 8, 2022, The Shares were valued at $65,352
on the grant date. |
| |
|
|
| |
● |
On July 9, 2021, a holder of 9,000 shares of Series B Preferred Stock converted such shares into 1,200,000 shares of Common Stock |
| |
|
|
| |
● |
On July 9, 2021, the Company sold 625 units at a price per unit
of $40.00 or an aggregate of $25,000. Each unit consisted of (i) one (1) share of Common Stock and (ii) a warrant to purchase
one half (1/2) of one share of Common Stock. The warrants have an exercise price per share of $60.00 per share and a term
of three (3) years. As a result of the offering, the Company issued 625 shares of Common Stock and warrants to purchase 312
shares of Common Stock. |
| |
|
|
| |
● |
On July 14, 2021, upon joining the Board, Marc Drimer was granted a
warrant to purchase 2,500 shares of Common Stock. The warrant has an exercise price of $49.60 per share, a term of
3 years from issuance and vests in 4 equal quarterly installments beginning July 14, 2021, and ending on July 14, 2022. The warrant
was valued at $34,382. Pursuant to Mr. Drimer’s passing, 1,250 shares underlying warrants vested and the remaining 1,250
that were unvested were cancelled. |
| |
● |
On August 9, 2021, pursuant to a settlement agreement, the Company
settled a lawsuit against the Company in exchange for (i) the payment of $100,000 in cash and (ii) the issuance of 5,000 shares
of Common Stock. The shares have piggyback registration rights and were valued at $180,000 on the date of grant. |
| |
|
|
| |
● |
On August 18, 2021, the Company sold 7,500 units at a price
per unit of $40.00 or an aggregate of $300,000. Each unit consisted of (i) one (1) share of Common Stock and (ii) a warrant
to purchase one (1) share of Common Stock. The warrants have an exercise price per share of $0.15 per share and a term of three (3)
years. As a result of the offering, the Company issued 7,500 shares of Common Stock and warrants to purchase 7,500
shares of Common Stock. |
| |
|
|
| |
● |
On August 19, 2021, the Company sold 2,777 units at a price
per unit of $36.00 or an aggregate of $100,000. Each unit consisted of (i) one (1) share of Common Stock and (ii) a warrant
to purchase one (1) share of Common Stock. The warrants have an exercise price per share of $56.00 per share and a term of
three (3) years. As a result of the offering, the Company issued 2,777 shares of Common Stock and warrants to purchase 2,777
shares of Common Stock. |
| |
|
|
| |
● |
On August 26, 2021, the Company issued a consultant 625 shares
of Common Stock for services that vest (i) 150 shares on the grant date, (ii) 150 shares on the 4-month anniversary
of issuance, (iii) 150 shares on the 8-month anniversary of issuance, and (iv) 175 shares on the 1-year anniversary
of issuance. The warrant was valued at $22,500. |
| |
|
|
| |
● |
On September 1, 2021, in conjunction with his resigning from the Board,
Michael Fish was granted 750 shares of Common Stock valued at $36,750. |
| |
|
|
| |
● |
On September 27, 2021, the Company entered into a consulting agreement
with a third-party advisor. Pursuant to the agreement, we agreed to issue the consultant (i) 625 shares of Common Stock valued
at $28,500 on the grant date and (ii) an option to purchase 1% of the issued and outstanding capital stock of the Company on a fully
diluted basis, or an aggregate of 20,202 options to purchase Common Stock (the “Consultant Option”). The Consultant
Option has an exercise price of $44.00 per share, a term of 10 years, and vests (i) 50% on issuance and (ii) 50% on the one
(1) year anniversary of the issuance date, subject to the consultant’s continued service to the Company. Additionally, upon
the Company completing a reverse stock split and capital raising transaction of at least $5,000,000, the consultant will receive
additional options such that the total Consultant Option including such additional options will remain as 1% of the fully diluted
capital stock of the Company. The option was valued at $436,908. |
| |
|
|
| |
● |
On October 1, 2021, the Company entered into a licensing agreement
with Mid-Atlantic Biotherapeutics, Inc. (“MABT”). Pursuant to the terms of the agreement we issued MABT 31,250
shares of Common Stock and agreed to issue MABT another 43,750 shares of Common Stock upon a successful IND Application with
the FDA as set forth in the agreement. The Common Stock grant issued on October 1, 2021 was valued at $1,425,000. |
| |
|
|
| |
● |
On November 12, 2021, the Company sold 1,008 units at a price
per unit of $0.062 or an aggregate of $25,000. Each unit consisted of (i) one (1) share of Common Stock and (ii) a warrant to purchase
one (1) share of Common Stock. The warrants have an exercise price per share of $44.00 per share and a term of three (3) years.
As a result of the offering, the Company issued 1,008 shares of Common Stock and warrants to purchase 1,008 shares
of Common Stock |
| |
|
|
| |
● |
Between December 10 and 15 of 2021, the Company sold an aggregate of
30,365 units to twelve (12) accredited investors at a price per unit of $16.40 or an aggregate of $498,000. Each unit
consisted of (i) one (1) share of Common Stock (ii) a warrant to purchase one (1) share of Common Stock with an exercise price of
$36.00 per share, and (iii) one (i) warrant to purchase one (1) share of Common Stock with an exercise price of $60.00
per share. The warrants have a term of three (3) years. As a result of the offering, the Company issued 30,365 shares
of Common Stock and warrants to purchase 60,731 shares of Common Stock. |
| |
|
|
| |
● |
On January 14, 2022, the Board granted 2,500 shares of common
stock valued at $51,750 to Paul Michaels and Options to purchase an aggregate of 18,641 shares of common stock at exercise
prices of $20.70 each to Barry Ginsberg, Richard Garr, and another employee. Each of the three option grants were valued at
$51,750. |
| |
|
|
| |
● |
On March 4, 2022, the Company issued a secured
convertible promissory note to Puritan Partners, LLC, an institutional investor, in aggregate principal of $1,142,857.14 for $1,000,000
in gross proceeds. The Note has a maturity date of March 2, 2023, accrues interest at 12.5% annually, with payments to be made monthly.
The investor received a first priority lien on substantially all of the Company’s assets. The Company also issued a warrant
to purchase 57,142 shares of Common Stock at an exercise price of $0.0001 and a term of five (5) years. The Company paid its
placement agent $102,500 upon completion of the transaction.
|
| |
|
|
| |
● |
On
August 18, 2022, pursuant to an amendment of the terms of the March 4, 2022 convertible promissory note and associated transaction
documents, the Company increased the number of shares of common stock underlying the warrant by 4,762. |
| |
|
|
| |
● |
On
October 14, 2022, pursuant to an amendment of the terms of the March 4, 2022, convertible promissory note and associated transaction
documents, as amended, the Company increased the number of shares of common stock underlying the warrant by 4,762. |
| |
|
|
| |
● |
On
November 16, 2022, pursuant to an amendment of the terms of the March 4, 2022, convertible promissory note and associated transaction
documents, as amended, the Company increased the number of shares of common stock underlying the warrant by 4,762. |
| |
|
|
| |
● |
On
December 16, 2022, pursuant to an amendment of the terms of the March 4, 2022, convertible promissory note and associated transaction
documents, as amended, the Company increased the number of shares of common stock underlying the warrant by 4,762. |
| |
|
|
| |
● |
Between
December 15 and 29 of 2022, the Company sold 146,000 shares of Series B Preferred Stock for $146,000. |
| |
|
|
| |
● |
Between
December 12 and 19 of 2022, there were 19,048 shares of common stock issued upon the exercise of warrants, which resulted in $152,390
of cash proceeds to the Company. |
Item
16. Exhibits.
See
Exhibit Index beginning on page II-7 of this Registration Statement.
Item
17. Undertakings.
The
undersigned registrant hereby undertakes:
(1)
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 (if the total dollar value of securities
offered would not exceed that which was registered) 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 SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and
price represent no more than a 20% 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 (1)(i), (ii) and (iii) above do not apply if the information required to be included in a post-effective
amendment by those paragraphs is contained in periodic reports filed with or furnished to the SEC by the registrant pursuant to Section
13 or Section 15(d) of the Exchange Act that are incorporated by reference in this registration statement, or is contained in a form
of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
(2)
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.
(3)
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.
(4)
That, for the purpose of determining liability under the Securities Act to any purchaser:
(i)
if the registrant is relying on Rule 430B:
(A)
Each prospectus filed by the 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; or
(ii)
if the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating
to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall
be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. 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 first use, 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 date of first
use.
(5)
That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution
of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant
to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities
are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to
the purchaser and will be considered to offer or sell such securities to such purchaser:
(i)
any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule
424;
(ii)
any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by
the undersigned registrant;
(iii)
the portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant
or its securities provided by or on behalf of the undersigned registrant; and
(iv)
any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
(6)
That:
| |
(i) |
For
purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part
of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant
to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time
it was declared effective. |
| |
|
|
| |
(ii) |
For
the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus
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 the registrant of expenses incurred or paid by a director, officer
or controlling person of the 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, the 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, this registration statement has been signed by the following persons in the capacities and
on the dates indicated.
| Signature |
|
Title |
|
Date |
| |
|
|
|
|
| /S/
I Richard Garr |
|
Chief
Executive Officer, Chief Financial Officer |
|
January
12, 2023 |
| I
Richard Garr |
|
(Principal
Executive Officer)
(Principal Financial and Accounting Officer) |
|
|
| |
|
|
|
|
| * |
|
President,
Director |
|
January
12, 2023 |
| Paul
Michaels |
|
|
|
|
| |
|
|
|
|
| * |
|
Chief
Strategy Officer, Director |
|
January
12, 2023 |
| Dr.
Barry Ginsberg |
|
|
|
|
| |
|
|
|
|
| * |
|
Director |
|
January
12, 2023 |
| Michael
Fish |
|
|
|
|
| |
|
|
|
|
| * |
|
Director |
|
January
12, 2023 |
| Cary Sucoff |
|
|
|
|
| |
|
|
|
|
| * |
|
Director |
|
January
12, 2023 |
| Lawrence Zaslow |
|
|
|
|
| *By: |
/S/
I Richard Garr |
|
| |
I
Richard Garr |
|
| |
Attorney-in-Fact |
|
INDEX
TO EXHIBITS
| |
|
|
|
|
|
Incorporated
by Reference |
| |
|
|
|
Filed/ |
|
|
|
|
|
|
|
|
| Exhibit |
|
|
|
Furnished |
|
|
|
Exhibit |
|
|
|
Filing |
| No. |
|
Description |
|
Herewith |
|
Form |
|
No. |
|
File
No. |
|
Date |
| |
|
|
|
|
|
|
|
|
|
|
|
|
| 1.01 |
|
Form of Underwriting Agreement |
|
|
|
S-1 |
|
1.01 |
|
333-268194 |
|
11/07/2022 |
| 3.01 |
|
Fourth Amended and Restated Articles of Incorporation dated January 27, 2021 |
|
|
|
S-1 |
|
3.01 |
|
333-268194 |
|
11/07/2022 |
| 3.02 |
|
Articles of Amendment to the Articles of Incorporation, dated September 26, 2022 |
|
|
|
S-1 |
|
3.02 |
|
333-268194 |
|
11/07/2022 |
| 3.03 |
|
Amended and Restated Bylaws of Curative Biotechnology, Inc. dated March 29, 2021 |
|
|
|
S-1 |
|
3.03 |
|
333-268194 |
|
11/07/2022 |
| 4.01 |
|
Specimen of Common Stock Certificate |
|
|
|
S-1 |
|
4.01 |
|
333-268194 |
|
11/07/2022 |
| 4.02 |
|
Specimen Series A Preferred Stock |
|
|
|
S-1 |
|
4.02 |
|
333-268194 |
|
11/07/2022 |
| 4.03 |
|
Specimen of Series B Preferred Stock |
|
|
|
S-1 |
|
4.03 |
|
333-268194 |
|
11/07/2022 |
| 4.04 |
|
Specimen of Series C Preferred Stock |
|
|
|
S-1 |
|
4.04 |
|
333-268194 |
|
11/07/2022 |
| 4.05 |
|
Form of Common Stock Purchase Warrant issued to Certain Consultants in May 2021 |
|
|
|
S-1 |
|
4.05 |
|
333-268194 |
|
11/07/2022 |
| 4.06 |
|
Form of Common Stock Purchase Warrant issued to Investors in August 2021 |
|
|
|
S-1 |
|
4.06 |
|
333-268194 |
|
11/07/2022 |
| 4.07 |
|
Form of Warrant issued to investors on May 21, 2021 |
|
|
|
S-1 |
|
4.07 |
|
333-268194 |
|
11/07/2022 |
| 4.08 |
|
Form of Warrant issued to Investors in Note Offering from November 2020 through January 2021 |
|
|
|
S-1 |
|
4.08 |
|
333-268194 |
|
11/07/2022 |
| 4.09 |
|
Form of Common Stock Purchase warrant issued to Consultant on December 3, 2020 |
|
|
|
S-1 |
|
4.09 |
|
333-268194 |
|
11/07/2022 |
| 4.10 |
|
Form of Consultant Warrants issued between December 2020 and January 2021 |
|
|
|
S-1 |
|
4.10 |
|
333-268194 |
|
11/07/2022 |
| 4.11 |
|
Form of Common Stock Purchase Warrant issued to Paul Michaels on June 11, 2021 |
|
|
|
S-1 |
|
4.11 |
|
333-268194 |
|
11/07/2022 |
| 4.12 |
|
Form of Common Stock Purchase Warrant issued to Marc Drimer on July 14, 2021 |
|
|
|
S-1 |
|
4.12 |
|
333-268194 |
|
11/07/2022 |
| 4.13 |
|
Form of Common Stock Purchase Option issued to Catherine Sohn pursuant to Consulting Agreement dated September 27, 2021 |
|
|
|
S-1 |
|
4.13 |
|
333-268194 |
|
11/07/2022 |
| 4.14** |
|
2021 Equity Incentive Plan |
|
|
|
S-1 |
|
4.14 |
|
333-268194 |
|
11/07/2022 |
| 4.15 |
|
Form of Stock Option Grant for 2021 Equity Incentive Plan |
|
|
|
S-1 |
|
4.15 |
|
333-268194 |
|
11/07/2022 |
| 4.16** |
|
Form of Restricted Stock Award Agreement for 2021 Equity Incentive Plan |
|
|
|
S-1 |
|
4.16 |
|
333-268194 |
|
11/07/2022 |
| 4.17 |
|
Form of Restricted Stock Unit Agreement for 2021 Equity Incentive Plan |
|
|
|
S-1 |
|
4.17 |
|
333-268194 |
|
11/07/2022 |
| 4.18 |
|
Form of Underwriter Warrant |
|
|
|
S-1 |
|
4.18 |
|
333-268194 |
|
11/07/2022 |
| 4.19 |
|
Form of warrant to be issued in Underwritten Offering |
|
|
|
S-1 |
|
4.19 |
|
333-268194 |
|
11/07/2022 |
| 5.01 |
|
Opinion of Lucosky Brookman LLP |
|
|
|
S-1 |
|
5.01 |
|
333-268194 |
|
11/16/2022 |
| 10.01 |
|
Form of Subscription Agreement for Investor Offerings in August 2021 |
|
|
|
S-1 |
|
10.01 |
|
333-268194 |
|
11/07/2022 |
| 10.02 |
|
Form of Subscription Agreement for Investor Offerings on May 21, 2021 |
|
|
|
S-1 |
|
10.02 |
|
333-268194 |
|
11/07/2022 |
| 10.03 |
|
Form of Note Issued to Investors between November 2020 and January 2021 |
|
|
|
S-1 |
|
10.03 |
|
333-268194 |
|
11/07/2022 |
| 10.04 |
|
Settlement Agreement dated August 9, 2021 |
|
|
|
S-1 |
|
10.04 |
|
333-268194 |
|
11/07/2022 |
| 10.05 |
|
Consulting Agreement dated September 27, 2021 |
|
|
|
S-1 |
|
10.05 |
|
333-268194 |
|
11/07/2022 |
| 10.06** |
|
Employment Agreement with Richard Garr dated October 1, 2020 |
|
|
|
S-1 |
|
10.06 |
|
333-268194 |
|
11/07/2022 |
| 10.07** |
|
Employment Agreement with Barry Ginsberg dated October 1, 2020 |
|
|
|
S-1 |
|
10.07 |
|
333-268194 |
|
11/07/2022 |
| 10.08** |
|
Employment Agreement with Paul Michaels dated October 1, 2020 |
|
|
|
S-1 |
|
10.08 |
|
333-268194 |
|
11/07/2022 |
| 10.09 |
|
License, Funding and Operational Agreement dated October 1, 2021 between Curative Biotechnology, Inc., David Horn, LLC, and Mid-Atlantic BioTherapeutics, Inc. |
|
|
|
S-1 |
|
10.09 |
|
333-268194 |
|
11/07/2022 |
| 10.10 |
|
Exclusive Option Agreement for Purchase of Patent Rights dated September 30, 2020 between Curative Biotechnology (fka Connectyx Technologies Holdings Group) and IEM Inc. |
|
|
|
S-1 |
|
10.10 |
|
333-268194 |
|
11/07/2022 |
| 10.11 |
|
Patent
License Agreement dated February 2, 2021 between National Institute of Health and Curative Biotechnology, Inc. (fka Connectyx Technologies
Holdings Group) |
|
|
|
S-1 |
|
10.11 |
|
333-268194 |
|
11/07/2022 |
| 10.12 |
|
Patent
License Agreement -Exclusive Evaluation Option License dated October 15, 2020 between National Institute of Health and Curative Biotechnology,
Inc. (fka Connectyx Technologies Holdings Group) |
|
|
|
S-1 |
|
10.12 |
|
333-268194 |
|
11/07/2022 |
| 10.13 |
|
License,
Funding and Operational Agreement dated September 30, 2020 between Mid-Atlantic BioTherapeutics, Inc., David Horn, LLC, and Curative
Biotechnology, Inc. (fka Connectyx Technologies Holdings Group) |
|
|
|
S-1 |
|
10.13 |
|
333-268194 |
|
11/07/2022 |
| 10.14 |
|
First
Amendment to License, Funding and Operational Agreement dated December 30, 2021 between Mid-Atlantic BioTherapeutics and Curative
Biotechnology, Inc. |
|
|
|
S-1 |
|
10.14 |
|
333-268194 |
|
11/07/2022 |
| 10.15 |
|
First
Amendment to License, Funding and Operational Agreement dated December 31, 2021 between Mid-Atlantic BioTherapeutics, Inc. and Curative
Biotechnology, Inc. |
|
|
|
S-1 |
|
10.15 |
|
333-268194 |
|
11/07/2022 |
| 10.16 |
|
Securities
Purchase Agreement for March 2022 Offering |
|
|
|
S-1 |
|
10.16 |
|
333-268194 |
|
11/07/2022 |
| 10.17 |
|
Secured
Convertible Promissory Note for March 2022 Offering |
|
|
|
S-1 |
|
10.17 |
|
333-268194 |
|
11/07/2022 |
| 10.18 |
|
Security
Agreement for March 2022 Offering |
|
|
|
S-1 |
|
10.18 |
|
333-268194 |
|
11/07/2022 |
| 10.19 |
|
Intellectual
Property Security Agreement for March 2022 Offering |
|
|
|
S-1 |
|
10.19 |
|
333-268194 |
|
11/07/2022 |
| 10.20 |
|
Warrant
for March 2022 Offering |
|
|
|
S-1 |
|
10.20 |
|
333-268194 |
|
11/07/2022 |
| 10.21 |
|
Form
of Lock Up Agreement for March 2022 Offering |
|
|
|
S-1 |
|
10.21 |
|
333-268194 |
|
11/07/2022 |
| 10.22*** |
|
Cooperative
Research and Development Agreement for Intramura-PhS Clinical Research |
|
|
|
S-1 |
|
10.22 |
|
333-268194 |
|
11/07/2022 |
| 10.23 |
|
First
Amendment to March 2022 Convertible Note Transaction Documents |
|
|
|
S-1 |
|
10.23 |
|
333-268194 |
|
11/07/2022 |
| 10.24 |
|
Second Amendment to March 2022 Convertible Note Transaction Documents |
|
|
|
S-1 |
|
10.24 |
|
333-268194 |
|
11/30/2022 |
| 10.25 |
|
Third Amendment to March 2022 Convertible Note Transaction Documents |
|
|
|
S-1 |
|
10.25 |
|
333-268194 |
|
11/30/2022 |
| 10.26 |
|
Fourth Amendment to March 2022 Convertible Note Transaction Documents |
|
|
|
S-1 |
|
10.26 |
|
333-268194 |
|
11/30/2022 |
| 10.27 |
|
Fifth Amendment to March 2022 Convertible Note Transaction Documents |
|
|
|
S-1 |
|
10.27 |
|
333-268194 |
|
11/30/2022 |
| 10.28 |
|
Sixth Amendment to March 2022 Convertible Note Transaction Documents |
|
|
|
S-1 |
|
10.28 |
|
333-268194 |
|
01/09/2023 |
| 10.29 |
|
Seventh Amendment to March 2022 Convertible Note Transaction Documents |
|
X |
|
|
|
|
|
|
|
|
| 10.30 |
|
Form
of Warrant Agency Agreement |
|
|
|
S-1 |
|
10.24 |
|
333-268194 |
|
11/07/2022 |
| 14.01 |
|
Code
of Ethics and Business Conduct |
|
|
|
S-1 |
|
14.01 |
|
333-268194 |
|
11/07/2022 |
| 23.01 |
|
Consent of Daszkal Bolton LLP |
|
X |
|
|
|
|
|
|
|
|
| 23.02 |
|
Consent of Lucosky Brookman LLP (contained in Exhibit 5.01 hereto) |
|
|
|
S-1 |
|
23.02 |
|
333-268194 |
|
11/16/2022 |
| 24.01 |
|
Power of Attorney (included on the signature page) |
|
|
|
S-1 |
|
24.01 |
|
333-268194 |
|
11/07/2022 |
| 99.01 |
|
Audit
Committee Charter |
|
|
|
S-1 |
|
99.01 |
|
333-268194 |
|
11/07/2022 |
| 99.02 |
|
Compensation
Committee Charter |
|
|
|
S-1 |
|
99.02 |
|
333-268194 |
|
11/07/2022 |
| 99.03 |
|
Governance
and Nominating Committee Charter |
|
|
|
S-1 |
|
99.03 |
|
333-268194 |
|
11/07/2022 |
| 107 |
|
Registration
Fee Table |
|
|
|
S-1 |
|
107 |
|
333-268194 |
|
11/07/2022 |
| 101.INS |
|
XBRL
Instance Document |
|
|
|
|
|
|
|
|
|
|
| 101.SCH |
|
XBRL
Taxonomy Extension Schema |
|
|
|
|
|
|
|
|
|
|
| 101.CAL |
|
XBRL
Taxonomy Extension Calculation Linkbase |
|
|
|
|
|
|
|
|
|
|
| 101.DEF |
|
XBRL
Taxonomy Extension Definition Linkbase |
|
|
|
|
|
|
|
|
|
|
| 101.LAB |
|
XBRL
Taxonomy Extension Label Linkbase |
|
|
|
|
|
|
|
|
|
|
| 101.PRE |
|
XBRL
Taxonomy Extension Presentation Linkbase |
|
|
|
|
|
|
|
|
|
|
**
Management contracts or compensation plans or arrangements in which directors or executive officers are eligible to participate.
***
Certain portions of this exhibit (indicated by “[***]”) have been omitted as we have determined (i) the omitted information
is not material and (ii) the omitted information would likely cause harm to us if publicly disclosed.
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