UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K/A
(Amendment
No. 1)
(Mark
One)
☒ ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the Fiscal Year Ended December 31, 2023
or
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission
file number: 001-40064
VIRPAX
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
| Delaware | | 82-1510982 |
(State
or other jurisdiction of
incorporation or organization) | | (I.R.S.
Employer
Identification No.) |
1055
Westlakes Drive, Suite 300 Berwyn,
PA | | 19312 |
| (Address
of principal executive offices) | | (Zip
Code) |
(610)
727-4597
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class: | | Trading
Symbol(s) | | Name
of each exchange on which registered |
| Common
Stock, par value $0.00001 per share | | VRPX | | The Nasdaq Capital Market |
Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No
☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes ☐ No ☒
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such
files). Yes ☒ No ☐
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 definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large
accelerated filer | ☐ | Accelerated
filer | ☐ |
| Non-accelerated
filer | ☒ | Smaller
reporting company | ☒ |
| | | Emerging
growth company | ☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to Section 240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
As
of March 22, 2024 the number of outstanding shares of the registrant’s common stock, par value $0.00001 per share, was 1,171,233.
As
of October 10, 2024, the number of outstanding shares of the registrant’s common stock, par value $0.00001 per share, was 1,171,233.
EXPLANATORY NOTE
Virpax Pharmaceuticals, Inc. (the “Company”) is filing this Amendment
No. 1 (this “Amendment”) to its Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “Form 10-K”)
to include the Report of Independent Registered Public Accounting Firm from Bush & Associates CPA LLC (“Bush & Associates
CPA”) for the consolidated financial statements for the fiscal year ended December 31, 2023. No other material changes have been
made to the Form 10-K. The consent of Bush & Associates CPA, dated as of the date of this Amendment, is included as an exhibit.
This Amendment does not reflect
events occurring after the original filing of the Form 10-K, nor does it update or revise the disclosures contained in the Form 10-K,
except as specifically noted above. In accordance with Rule 12b-15 under the Securities Exchange Act of 1934, as amended, this Amendment
includes the complete text of Item 8. Financial Statements, as well as the certifications of the Company’s Principal Executive Officer
and Principal Financial Officer required under Sections 302 and 906 of the Sarbanes-Oxley Act of 2002, as amended, dated as of the date
of this Amendment.
DOCUMENTS INCORPORATED BY REFERENCE
None.
VIRPAX PHARMACEUTICALS, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023
TABLE OF CONTENTS
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking
statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements
include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or
strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future
events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,”
“contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,”
“may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,”
“should,” “will,” “would” and similar expressions may identify forward-looking statements, but the
absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this report on Annual Report
on Form 10-K may include, for example, statements about:
| ● | our
lack of operating history; |
| ● | the
expectation that we will incur significant operating losses for the foreseeable future and will need significant additional capital; |
| |
● |
our current and future
capital requirements to support our development and commercialization efforts for our product candidates and our ability to satisfy
our capital needs; |
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|
|
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● |
the outcome of certain current litigation in which
we and our former Chief Executive Officer are named as defendants (See Part 1-Item 1A-Risk Factors, Item 3-Legal Proceedings);
|
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● |
our ability to raise additional
capital; |
|
● |
our dependence on our product
candidates, which are still in preclinical or early stages of clinical development; |
| |
|
|
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● |
our, or that of our third-party manufacturers,
ability to manufacture current good manufacturing practice (“cGMP”) quantities of our product candidates as required
for preclinical and clinical trials and, subsequently, our ability to manufacture commercial quantities of our product candidates; |
| |
● |
our ability to complete
required clinical trials for our product candidates and obtain approval from the US Food and Drug Administration (“FDA”)
or other regulatory agencies in different jurisdictions; |
| |
● |
our lack of a sales and
marketing organization and our ability to commercialize our product candidates if we obtain regulatory approval; |
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● |
our dependence on third-parties to
manufacture our product candidates; |
| |
● |
our reliance on third-party contract
research organizations (“CROs”) to conduct our clinical trials; |
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● |
our ability to maintain
or protect the validity of our intellectual property; |
| |
● |
our ability to internally
develop new inventions and intellectual property; |
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● |
interpretations of current
laws and the passages of future laws; |
| |
● |
acceptance of our business
model by investors; |
| |
● |
the accuracy of our estimates
regarding expenses and capital requirements; |
| |
● |
our ability to maintain
our Nasdaq listing; and |
| |
● |
our ability to adequately
support organizational and business growth |
The foregoing does not represent an exhaustive
list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may
cause our actual results to differ from those anticipated in such forward-looking statements. Please see “Part I—Item 1A—Risk
Factors” for additional risks which could adversely impact our business and financial performance.
All forward-looking statements are expressly
qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements,
which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation,
and expressly disclaims any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new
information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and believe they have
a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.
PART I
ITEM 1. BUSINESS
Forward-Looking Statements
This Annual Report contains forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E
of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve substantial risks and uncertainties.
The forward-looking statements are contained principally in Part I, Item 1. “Business,” Part I, Item 1A.
“Risk Factors,” and Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and
Results of Operations,” but are also contained elsewhere in this Annual Report and in some cases you can identify forward-looking
statements by terminology such as “may,” “should,” “potential,” “continue,” “expects,”
“anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions.
These statements are based on our current beliefs, expectations, and assumptions and are subject to a number of risks and uncertainties,
many of which are difficult to predict and generally beyond our control, that could cause actual results to differ materially from those
expressed, projected or implied in or by the forward-looking statements.
You should refer to Item 1A. “Risk
Factors” section of this Annual Report for a discussion of important factors that may cause our actual results to differ materially
from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking
statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the
inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these
statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time
frame, or at all. We do not undertake any obligation to update any forward-looking statements. Unless the context requires otherwise,
references to “we,” “us,” “our,” and “Virpax,” refer to Virpax Pharmaceuticals, Inc.
and its subsidiaries.
Summary Risk Factors
Risks Related to Our Financial Position and
Need for Additional Capital
| ● | We
are a preclinical stage biopharmaceutical company with a limited operating history. |
| ● | We
have incurred losses since inception and anticipate that we will continue to incur losses
for the foreseeable future. We are not currently profitable, and we may never achieve or
sustain profitability. |
| ● | The
report of our independent registered public accounting firm for the fiscal years ended December
31, 2023 and 2022 contains an explanatory paragraph regarding substantial doubt about our
ability to continue as a going concern. |
| ● |
We will require additional capital to fund our operations, we may not
be able to raise additional capital, and if we fail to obtain necessary financing, we will not be able to complete the development and
commercialization of our drugs. |
| ● |
Raising additional capital will cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. |
| ● |
Our ability to use our net operating loss carryforwards to offset future taxable income will be subject to certain limitations. |
| ● |
Our ability to further develop our product candidates will be adversely
affected by the terms of the Settlement Agreement (See Part 1-Item 1A-Risk Factors, Item 3-Legal Proceedings and Recent Developments –
Litigation). |
| ● |
The Company has been affected by significant litigation which requires the Company to pay an additional $2.5M by July 1, 2024, as part of the Settlement Agreement, and may in the future be affected by new litigation and indemnification and contribution claims related to our recently settled litigation with Sorrento Therapeutics, Inc. and Scilex Pharmaceuticals, Inc., which such claims may be material, and potential estimated separation payments that we make to our former Chief Executive Officer, which may be material. In addition, our officers and directors may be subject to various types of litigation in the future, and our insurance may not be sufficient to cover damages related to those claims. See “Risk Factor- Our business, financial condition and results of operations could be adversely affected by indemnification and other claims related to the damages awarded in our recently settled litigation with Sorrento Therapeutics, Inc. and Scilex Pharmaceuticals, Inc”, (See Part 1-Item 1A-Risk Factors, and Item 3-Legal Proceedings and Recent Developments – Litigation). |
Risks Related
to Development, Clinical Testing, Manufacturing and Regulatory Approval
| ● | Clinical
trials are expensive, time-consuming and difficult to design and implement, and involve an
uncertain outcome. |
| ● | Disruptions
in the global economy and supply chains may have a material adverse effect on our business,
financial condition and results of operations. |
| ● | Adverse
global conditions, including economic uncertainty, may negatively impact our financial results. |
| ● | Our
development activities for Probudur are conducted in Israel. The war in the Middle East,
may affect our operations. |
| ● | The
regulatory approval processes of the FDA and comparable foreign authorities are lengthy,
time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory
approval for our Product Candidates or any other product candidates, our business will be
substantially harmed. |
| ● | If
we are unable to file for approval of Epoladerm and Probudur under Section 505(b)(2)
of the FDCA or if we are required to generate additional data related to safety and efficacy
in order to obtain approval under Section 505(b)(2), we will be unable to meet our anticipated
development and commercialization timelines. |
| ● | Enrollment
and retention of patients in clinical trials is an expensive and time-consuming process and
could be made more difficult or rendered impossible by multiple factors outside our control. |
| ● | The
COVID-19 pandemic has adversely affected our business and a resurgence of COVID-19 or another
health epidemic or pandemic may have an adverse impact on our business in the future. |
| ● | Results
of preclinical studies, early clinical trials or analyses may not be indicative of results
obtained in later trials. |
| ● | Interim
“top-line” and preliminary data from our clinical trials that we announce or
publish from time to time may change as more patient data become available and are subject
to audit and verification procedures that could result in material changes in the final data. |
| ● | Our
product candidates may cause serious adverse events or undesirable side effects, which may
delay or prevent marketing approval, or, if approved, require them to be taken off the market,
require them to include safety warnings or otherwise limit their sales. |
| ● | The
market opportunities for our Product Candidates, if approved, may be smaller than we anticipate. |
| ● | We
have never obtained marketing approval for a product candidate and we may be unable to obtain,
or may be delayed in obtaining, marketing approval for any of our product candidates. |
| ● | Even
if we obtain FDA approval for our Product Candidates or any other product candidate in the
United States, we may never obtain approval for or commercialize our Product Candidates
or any other product candidate in any other jurisdiction, which would limit our ability to
realize their full market potential. |
| ● | Even
if we obtain regulatory approval for our Product Candidates or any product candidate, we
will still face extensive and ongoing regulatory requirements and obligations and any product
candidates, if approved, may face future development and regulatory difficulties. |
| ● | Potential
product liability lawsuits against us could cause us to incur substantial liabilities and
limit commercialization of any products that we may develop. |
Risks Related
to Commercialization
| ● | We
face significant competition from other biotechnology and pharmaceutical companies and our
operating results will suffer if we fail to compete effectively. |
| ● | The
successful commercialization of our Product Candidates and any other product candidate we
develop will depend in part on the extent to which governmental authorities and health insurers
establish adequate coverage, reimbursement levels, and pricing policies. Failure to obtain
or maintain coverage and adequate reimbursement for our product candidates, if approved,
could limit our ability to market those products and decrease our ability to generate revenue. |
| ● | Even
if our Product Candidates or any product candidate we develop receives marketing approval,
it may fail to achieve market acceptance by physicians, patients, third-party payors or others
in the medical community necessary for commercial success. |
| ● | If
we are unable to establish sales, marketing, and distribution capabilities either on our
own or in collaboration with third parties, we may not be successful in commercializing our
Product Candidates, if approved. |
| ● | A
variety of risks associated with operating internationally could materially adversely affect
our business. |
Risks Related
to Our Dependence on Third Parties
| ● | Our
employees and independent contractors, including principal investigators, CROs, consultants,
vendors, and any third parties we may engage in connection with development and commercialization,
may engage in misconduct or other improper activities, including noncompliance with regulatory
standards and requirements, which could have a material adverse effect on our business. |
| ● | We
currently rely on third-party contract manufacturing organizations (“CMOs”) for
the production of clinical supply of our Product Candidates and intend to rely on CMOs for
the production of commercial supply of our Product Candidates, if approved. Our dependence
on CMOs may impair the development and commercialization of the drug, which would adversely
impact our business and financial position. |
| ● | We
intend to rely on third parties to conduct, supervise and monitor our clinical trials. If
those third parties do not successfully carry out their contractual duties, or if they perform
in an unsatisfactory manner, it may harm our business. |
Risks Related
to Healthcare Laws and Other Legal Compliance Matters
| ● | Enacted
and future healthcare legislation may increase the difficulty and cost for us to obtain marketing
approval of and commercialize our product candidates, if approved, and may affect the prices
we may set. |
| ● | Our
business operations and current and future relationships with investigators, healthcare professionals,
consultants, third-party payors, patient organizations, and customers will be subject to
applicable healthcare regulatory laws, which could expose us to penalties. |
| ● | Any
clinical trial programs we conduct or research collaborations we enter into in the European
Economic Area may subject us to the General Data Protection Regulation. |
| ● | We
are subject to environmental, health and safety laws and regulations, and we may become exposed
to liability and substantial expenses in connection with environmental compliance or remediation
activities. |
Risks Related
to Our Intellectual Property
| ● | If
we fail to comply with our obligations under our existing intellectual property licenses,
we risk losing the rights to our intellectual property. |
| ● | If
we are unable to obtain and maintain patent protection for our technology, products, and
product candidates or if the scope of the patent protection obtained is not sufficiently
broad, we may not be able to compete effectively in our markets. |
| ● | We
may become subject to third parties’ claims alleging infringement of their patents
and proprietary rights, or we may need to become involved in lawsuits to protect or enforce
our patents, which could be costly, time consuming, delay or prevent the development and
commercialization of our products and product candidates or put our patents and other proprietary
rights at risk. |
| ● | We
may not identify relevant third-party patents or may incorrectly interpret the relevance,
scope or expiration of a third-party patent, which might adversely affect our ability to
develop, manufacture and market our products and product candidates. |
| ● | Changes
in patent laws or patent jurisprudence could diminish the value of patents in general, thereby
impairing our ability to protect our products and product candidates. |
| ● | Obtaining
and maintaining our patent protection depends on 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. |
| ● | We
enjoy only limited geographical protection with respect to certain patents and we may not
be able to protect our intellectual property rights throughout the world. |
| ● | If
we do not obtain patent term extension in the United States under the Hatch-Waxman Act
and in foreign countries under similar legislation, thereby potentially extending the term
of marketing exclusivity for our products, our business may be materially harmed. |
| ● | Intellectual
property rights do not address all potential threats to our competitive advantage. |
| ● | Our
reliance on third parties requires us to share our trade secrets, which increases the possibility
that our trade secrets will be misappropriated or disclosed, and confidentiality agreements
with employees and third parties may not adequately prevent disclosure of trade secrets and
protect other proprietary information. |
| ● | If
our trademarks and trade names are not adequately protected, then we may not be able to build
name recognition in our markets of interest and our business may be adversely affected. |
| ● | We
may need to license certain intellectual property from third parties, and such licenses may
not be available or may not be available on commercially reasonable terms. |
| ● | We
may be subject to claims that our employees, consultants, collaborators contractors or advisors
have wrongfully used or disclosed confidential information of their former employers or other
third parties. |
| ● | Our
proprietary information may be lost, or we may suffer security breaches. |
Risks Related
to Our Employees, Managing Our Growth and Our Operations
| ● | We
have experienced turnover in our senior management team, and the loss of one or more of our
executive officers or key employees or an inability to attract and retain highly skilled
employees could adversely affect our business. |
| ● | We
expect to expand our development, regulatory, and sales and marketing capabilities, and as
a result, we may encounter difficulties in managing our growth, which could disrupt our operations. |
| ● | We
may engage in acquisitions that could disrupt our business, cause dilution to our stockholders
or reduce our financial resources. |
| ● | Our
business and operations would suffer in the event of system failures. |
| ● | We
are increasingly dependent on information technology, and our systems and infrastructure
face certain risks, including cybersecurity and data leakage risks. |
Risks Related
to Our Common Stock
| ● |
Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a de-listing of our common stock. |
| ● | The
market price of our common stock has been volatile and can fluctuate substantially, which
could result in substantial losses for purchasers of our common stock. |
| ● | We
could be subject to securities class action litigation. |
| ● | Our
directors, executive officers and certain stockholders (one of which is an affiliate of our
former Chief Executive Officer) will continue to own a significant percentage of our common
stock and, if they choose to act together, will be able to exert significant control over
matters subject to stockholder approval. |
| ● | If
securities or industry analysts do not publish research or reports about our business, or
if they issue an adverse or misleading opinion regarding our common stock, our stock price
and trading volume could decline. |
| ● | Because
we do not anticipate paying any cash dividends on our common stock in the foreseeable future,
capital appreciation, if any, will be your sole source of gain. |
| ● | We
have incurred and will continue to incur increased costs as a result of operating as a public
company, and our management will be required to devote substantial time to new compliance
initiatives and corporate governance practices. |
| ● | We
are an “emerging growth company,” and the reduced reporting requirements applicable
to emerging growth companies may make our common stock less attractive to investors. |
| ● | Anti-takeover
provisions contained in our certificate of incorporation and bylaws, as well as provisions
of Delaware law, could impair a takeover attempt. |
| ● | Our
certificate of incorporation, as amended, designates the Court of Chancery of the State of
Delaware as the sole and exclusive forum for certain types of actions and proceedings that
may be initiated by our stockholders, which could limit our stockholders’ ability to
obtain a favorable judicial forum for disputes with us or our directors, officers or other
employees. |
Our Company
We are a preclinical-stage pharmaceutical company
focused on developing novel and proprietary drug delivery systems across various pain indications in order to enhance compliance and
optimize each product candidate in our pipeline. Our drug-delivery systems and drug-releasing technologies being developed are focused
on advancing non-opioid and non-addictive pain management treatments and treatments for central nervous system (“CNS”) disorders
to enhance patients’ quality of life.
We have exclusive global rights to the following
proprietary patented technologies: (i) Molecular Envelope Technology (“MET”) that uses an intranasal device to deliver enkephalin
for the management of severe pain, including post cancer pain (Envelta™) and post-traumatic stress disorder (“PTSD”),
(ii) Injectable “local anesthetic” Liposomal Technology for postoperative pain management (Probudur™), and (iii) Investigational
formulation delivered via the nasal route to enhance pharmaceutical-grade cannabidiol (“CBD”) transport to the brain (“NobrXiol™”,
formerly VRP324) to potentially treat epileptic seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in pediatric
patients two years of age and older. We are also exploring value creative opportunities for our two nonprescription product candidates
including seeking regulatory approval for commercialization of such products: AnQlarTM, which is being developed as a 24 hour
prophylactic viral barrier to inhibit viral infection by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac
epolamine metered dosed spray film formulation being developed to manage pain associated with osteoarthritis.
Recent Developments
Reverse Stock Split
On February 29, 2024, we filed a certificate
of amendment to our Amended and Restated Certificate of Incorporation for purposes of effecting a 1-for-10 reverse stock split (the “Reverse
Split”) of our outstanding shares of common stock such that, effective upon March 1, 2024, the day after the filing thereof, every
10 issued and outstanding shares of our common stock were subdivided and reclassified into one validly issued, fully paid and non-assessable share
of our common stock.
Litigation
On February 29, 2024, Sorrento Therapeutics, Inc.
(“Sorrento”), and Scilex Pharmaceuticals Inc. (“Scilex” and together with Sorrento, the “Plaintiffs”)
and the Company entered into a Settlement Agreement and Mutual Release (the “Settlement Agreement”) to fully resolve all issues
related to the litigation with Plaintiffs captioned Sorrento Therapeutics, Inc. and Scilex
Pharmaceuticals Inc. v. Anthony Mack and Virpax Pharmaceuticals, Inc., Case No. 2021-0210-PAF (the “Action”), subject
to the entry by the United States Bankruptcy Court for the Southern District of Texas, which is handling the Sorrento bankruptcy filing
(the “Bankruptcy Court”), of an order approving the Settlement Agreement (the “Settlement Order”). On March 1,
2024, the Plaintiffs filed a motion to approve the Settlement Agreement and grant the related relief with the Bankruptcy Court. On March
14, 2024, the Bankruptcy Court entered an order approving the Settlement Agreement and on March 20th the Plaintiffs filed a Stipulation
of Dismissal with the Chancery Court dismissing the Action. See “Part I—Item 3—Legal Proceedings” for additional
information regarding the litigation with the Plaintiffs.
As settlement consideration, the Company agreed
to pay Sorrento and Scilex a total cash payment of $6 million, of which $3.5 million was paid two business days after the date that the
Settlement Order was entered by the Bankruptcy Court (the “Effective Date”), which payment was made on March 18, 2024 and
the remaining $2.5 million is to be paid on or before July 1, 2024. Additionally, the Company agreed to pay to Plaintiffs royalties of
6% of annual net sales of products developed from drug candidates Epoladerm, Probudur and Envelta until the earlier of the expiration
of the last-to-expire valid patent claim of such product and the expiration of any period of regulatory exclusivity for such product.
Pursuant to the Settlement Agreement, each of
the Plaintiffs and the Company provided mutual releases of all claims as of the Effective Date, whether known or unknown, arising from
any allegations set forth in the Action. Plaintiffs’ release relates to claims against the Company only. Plaintiffs’ release
as to the Company was effective upon the Company’s initial payment of $3.5 million, and the Company’s release of the Plaintiffs
was effective on the Effective Date.
Our Portfolio
Our portfolio currently consists of multiple
preclinical stage product candidates: Epoladerm, Probudur, Envelta, AnQlar and NobrXiol. In the accompanying section we will describe
each product candidate, its benefits, and our market strategy for each product candidate. The dates reflected in the below table are
estimates only, and there can be no assurances that the events included in the table will be completed on the anticipated timeline presented,
or at all.
Long-acting Bupivacaine 3.0% (LBL100 or Probudur™)
Probudur is a drug product candidate based on
a unique liposomal delivery system utilizing multi-lamellar vesicles (“MLV”) encapsulating a high dose of the local anesthetic
bupivacaine. Early preclinical animal studies produced data which demonstrated that Probudur provided significantly improved onset and
duration of analgesic effect as compared to a similar product on the market. The animal studies were conducted by infiltrating the surgical/wound
site with Probudur. Probudur’s prolonged effectiveness is due to the formulation’s ability to keep the local anesthetic at
the surgical/wound site for an extended period of time (at least 96 hours). Four nonclinical trials were conducted using three animal
models. Data from these animal studies showed that after treatment with Probudur (50 mg/kg), statistically demonstrated significant analgesic
activity (measured as threshold pressure at animal’s withdrawal of the treated extremity) was observed in comparison to control
(vehicle), for as long as 96 hours post-treatment (22.33±3.67g vs 5.00±0.58g; p<0.05), which is 24 hours longer than
the leading product on the market.
If we are able to demonstrate a successful Phase
III clinical trial, we believe Probudur may represent the first long-acting local anesthetic with an opioid sparing label. The slow release
of the drug from the liposomal depot reduces the peak plasma levels, reducing toxicity while also potentially providing longer-lasting
postoperative pain control. We believe this property may permit administration of higher bupivacaine doses (3% versus 1.3% in leading
market product); however, there can be no assurances, based on these animal studies, that Probudur will be safe and effective as these
determinations are solely within the authority of the FDA. Further, there can be no assurance that Probudur will receive FDA approval.
Image 2 below illustrates the results of the
early animal studies of Probudur:
Image 2
In September 2023, we announced results of two pre-clinical Probudur
dose escalation studies, where superior efficacy was demonstrated in head-to-head animal studies against Exparel®. The
first study compared Probudur to Exparel utilizing a planar incision model. Two doses of Probudur, at 3 mg and 6 mg, were administered
to rats. The results demonstrated three times longer efficacy for Probudur than Exparel. In the second study, two different formulations
at the same dose of Probudur were compared to Exparel in rat incision models. In this study, Probudur demonstrated a four to five times
longer effect than the comparable product.
In the studies, Probudur demonstrated longer
duration and higher peak activity compared to Exparel. Persistent analgesia (sustained pain control) with Probudur was noted at 96 hours,
which is 24 hours longer than claims of our competitors. Probudur also demonstrated biphasic release for fast onset and duration and
peak activity at 6 hours with a single injection. Additional studies for efficacy, toxicity, and pharmacokinetics are ongoing. Assuming
the success of our Phase 3 trials, we believe that Probudur has the potential to receive Opioid Sparing Label.
We plan to market Probudur to general surgeons,
anesthesiologists, and orthopedic surgeons within the $35 billion postoperative pain management market. Based on head-to-head preclinical
studies compared to an approved liposomal bupivacaine formulation, if used appropriately, we believe Probudur has the potential to eliminate
or significantly reduce the need to prescribe opioids for postoperative pain relief. As a result of our pre-IND meeting, the FDA has indicated
that it is reasonable for us to pursue a 505(b)(2) NDA for Probudur. There can be no assurance that we will be successful in securing
regulatory approval under the 505(b)(2) pathway or that we will be successful in mitigating risks associated with the clinical development
of this product candidate. The development of the Probudur formulation was successfully completed in the third quarter of 2023. We anticipate
relevant provisional patents will be filed in the first half of 2024. Lipocure RX, Ltd. (“Lipocure”) is currently in the process
of working through the scale up of Probudur to a larger batch size. IND enabling studies have started. The FDA minutes indicated that
we are to initiate our clinical studies in targeted patient populations following the completion of our nonclinical toxicity studies.
We anticipate filing an IND in 2024; however, we may need to adjust this timeline if Lipocure, a company based in Israel, becomes unable
to continue development work due to the war in the Middle East.
Image 3, below, displays the planned delivery
of Probudur at the wound site:
Image 3
Current Development Status
Our research and development activities for our
product candidates are performed for us by third parties that we contract with.
On June 30, 2021, we entered into an Agreement
for Rendering of Research Services with Yissum Research Development Company of the Hebrew University of Jerusalem Ltd (“Yissum”)
(the “June 2021 Yissum Research Agreement”). Under the June 2021 Yissum Research Agreement, we provided funding for research
and development studies performed by researchers at Hebrew University related to the optimization of the Liposomal Bupivacaine formulation
of Probudur and to increase stability for manufacturing purposes. In consideration for the research services, we paid research service
fees of $337,500. On January 31, 2023, we entered into an Agreement for Rendering of Research Services with Yissum (the “January
2023 Yissum Research Agreement”) on substantially similar terms and conditions as detailed above under the June 2021 Yissum Research
Agreement. In consideration for the research services, we paid research service fees of $326,000. On January 1, 2024, we entered into
an Agreement for Rendering of Research Services with Yissum (the “January 2024 Yissum Research Agreement”) for additional
work on formulation, method development, animal studies and patent related work. In consideration for the research services, we will pay
research service fees of $343,467 in four equal quarterly installments. We may terminate the agreement at any time and will only be responsible
to pay Yissum for work performed through the date of termination.
On June 29, 2021, we entered into an Agreement
for Rendering of Research Services with Lipocure RX, Ltd. (the “June 2021 Lipocure Research Agreement”). Under the June 2021
Lipocure Research Agreement, we provided funding for research and development related to the optimization of the Liposomal Bupivacaine
formulation of Probudur and eventual manufacturing of preclinical batches including for stability testing, animal studies, toxicology,
and patent related work. In consideration for the research services, we paid research service fees of $1,890,000. On February 1, 2023,
we entered into an Agreement for Rendering of Research Services (the “February 2023 Lipocure Research Agreement”) with Lipocure
on similar terms and conditions and for similar services - optimization of the Liposomal Bupivacaine formulation, manufacture of pre-clinical
batches including batches for stability testing, animal studies and toxicology work. In consideration for the research services, we paid
research service fees of $1,453,000 for the year ended December 31, 2023.
On April 28, 2022, we entered into a cooperative
research and development agreement (“CRADA”) with the U.S. Army Institute of Surgical Research (“USAISR”) to
evaluate Probudur as a potential novel analgesics for battlefield injury-induced pain solution. The current research project will evaluate
the analgesic effectiveness and physiologic effects of Probudur. The initial term of the agreement was to expire on September 30, 2023
unless it was revised by mutual written agreement. The CRADA was modified and signed on October 10, 2023, and extended the terms of the
agreement until September 2024. No funding is being provided by either party to the other party under the agreement. Each party is responsible
for funding its own work performed and other activities undertaken for the research project under this agreement. The parties may elect
to terminate this agreement, or portions thereof, at any time by mutual consent. Either party may unilaterally terminate this entire
agreement at any time by giving the other party written notice, not less than thirty (30) days prior to the desired termination date.
Molecular Envelope Technology Enkephalin Intranasal
Spray (Envelta™)
Envelta™ is a nanotechnology-based
intranasal spray drug product candidate which enables the delivery of a metabolically labile peptide drug (Enkephalin) into the brain.
It is manufactured using high pressure homogenization and spray drying. There is pharmacological evidence of activity of MET enabled
enkephalin in morphine-tolerant animals. Preclinical studies were conducted in animals for between 6 and 28 days through intravenous,
oral and intranasal dosing. Twelve studies were conducted using three animal models whereby the animal studies were aimed at determining
safety pharmacology and genetic toxicology. The preliminary data from these early animal studies of Envelta have shown that Envelta exhibited
pain control in morphine tolerant animals, without the development of tolerance itself. These animal models tested the anti-hyperalgesic
effects in rats against evoked stimuli in a model of chronic inflammatory pain and against ongoing neuropathic pain in a conditioned
placement preference model with spinal nerve ligation. Envelta and morphine were compared at the same dose level of 7.5 mg kg-1
in this model and Envelta was determined to have a similar analgesic effect. With respect to respiratory depression, delta opioid
receptor agonists may actually reverse the respiratory depression caused by morphine agonists, meaning that we believe Envelta will be
unlikely to cause respiratory depression. However, there can be no assurances, based on these preclinical animal studies, that Envelta
will be safe and effective. Further, there can be no assurance that Envelta will receive FDA approval.
We believe we have identified a large unmet need
and market opportunity for current prescribers of opioids, including pain and hospice treatment centers. Currently, these prescribers
may be using morphine-like opioids, which target three opioid receptors: mu, delta and kappa. Most analgesics used clinically target
mu receptor, however, this receptor is also responsible for the majority of undesirable side effects associated with opioids. Currently,
enkephalins are limited in their therapeutic potential by their pharmacokinetic profiles due to their inability to cross the blood-brain
barrier to reach opioid receptors located in the central nervous system. However, we believe Envelta’s novel nasally delivered
formulation, based on early animal studies, enhances enkephalin transport to the brain by protecting the drug in a MET, facilitating
its crossing of the blood-brain barrier. Enkephalins, which are naturally occurring analgesics that are quickly metabolized in the body
and lack an endogenous mechanism to allow them to cross the blood-brain barrier and reach their target delta-receptor, bind predominantly
to the delta-receptor which is typically not associated with the dangers associated with opioids. Envelta has many competitive advantages
including naturally occurring analgesics in our body, delta receptor agonist, the absence of liver first pass effect, and a comparable
efficacy to morphine. We believe Envelta may have analgesic potential without opioid tolerance, and has not exhibited any indications
of withdrawal, respiratory depression, euphoria, or addiction in the early animal studies. A study published in Proceedings of the National
Academy of Sciences (PNAS) indicates, “Delta opioid receptors have a built-in mechanism for pain relief and can be precisely targeted
with drug-delivering nanoparticles, making them a promising target for treating chronic inflammatory pain with fewer side effects.”
There can be no assurances, based on these preclinical animal studies, that Envelta will be safe and effective in human trials.
Additionally, we believe Envelta may significantly
reduce constipation and early animal clinical trials have not demonstrated any opioid dependence, drug seeking or respiratory depression.
We plan to use the endogenous NCE regulatory pathway to bring this product candidate to market. We plan to target our marketing and selling
efforts to pain specialists, anesthesiologists, orthopedics, surgeons, PCPs, Nurse Practitioners (“NPs”), oncologists, and
neurologists treating patients with severe pain, including post cancer pain, which market is valued at approximately $20 billion.
Envelta is a neuroactive peptide drug product
(enkephalin) with a proprietary composition formulated for administration by all routes except the topical route. A preassembled device
and cartridge would be used to propel the enkephalin formulation through the nose to the brain via the olfactory nerve/bulb route of
transmission. MET will encapsulate the drug product, protecting it from degradation, and help to carry the drug across the blood-brain
barrier to promptly suppress pain.
Image 4 and Image 5, below, display the planned
delivery of enkephalin peptide nanoparticles to the brain via the olfactory route:
Image 4
Image 5
Image 6 below illustrates the concept Envelta delivery device:
Image 6
Current Development Status
On August 25, 2020, we entered into the CRADA
with NCATS. This collaboration is for the continued development of our product candidate, Envelta, an intranasal peptide, to control severe
pain, including post cancer pain. The term of the CRADA is for a period of four years from the effective date of the agreement and can
be terminated by both parties at any time by mutual written consent. In addition, either party may unilaterally terminate the CRADA at
any time by providing written notice of at least sixty (60) days before the desired termination date. The agreement provides for studies
that are focused on the pre-clinical characterization of Envelta as a novel analgesic to control severe pain, including post cancer pain.,
and for studies to further develop Envelta through IND enabling studies. There are certain development “Go/No Go” provisions
within the agreement whereby, if certain events occur, or do not occur, NCATS may terminate the CRADA. These “No GO” provisions
include: i) lack of efficacy in all animal pain models, ii) no reliable and sensitive bioanalytical method can be developed, iii) manufacturing
failure due to inherent process scalability issues, iv) unacceptable toxicity or safety profile to enable clinical dosing, and v)
inability to manufacture the Envelta dosage form. As of March 25, 2024, we have not received any Go/No Go notifications from NCATS.
With respect to NCATS rights to any invention
made solely by an NCATS employee(s) or made jointly by an NCATS employee(s) and our employee(s), the CRADA grants to us an exclusive
option to elect an exclusive or nonexclusive commercialization license. For inventions owned solely by NCATS or jointly by NCATS and
us, and licensed pursuant to our option, we must grant to NCATS a nonexclusive, nontransferable, irrevocable, paid-up license to practice
the invention or have the invention practiced throughout the world by or on behalf of the United States government. For inventions
made solely by an employee of ours, we grant to the United States government a nonexclusive, nontransferable, irrevocable, paid-up
license to practice the invention or have the invention practiced throughout the world by or on behalf of the United States government
for research or other government purposes.
We believe Envelta may provide prescribers, regulators,
and patients alternative non-addictive treatment options to control severe pain, including post cancer pain and potentially manage symptoms
related to PTSD. We plan to utilize these delivery technologies to selectively develop a portfolio of patented NCE candidates for commercialization.
Four planned in vitro studies were successfully completed as well as the in vivo acute efficacy studies. In February 2022, we completed
a 14-day intranasal dose range finding toxicity study of Envelta in rats with a 14-day recovery period which showed no adverse related
findings in hematology, coagulation and serum chemistry data, with no treatment related toxicology findings or mortality noted. A 14-day
intranasal dose range finding toxicity study of Envelta in dogs with a 14-day recovery period was also conducted and showed no adverse
toxicologic findings. The preclinical studies under the CRADA are expected to continue over the next nine months. We anticipate filing
an IND in 2024. However, the IND timing is subject to risks in manufacturing of the MET/LENK, COA for GMP material and filling of cartridges
for a 28-day dog bridging study and may be extended into 2025.
Cannabidiol Nanoparticles with Molecular Envelope
Technology (NobrXiol™)
NobrXiol™ is being developed by Nanomerics
Ltd. (‘Nanomerics”) as an investigational formulation delivered via the nasal route that uses MET as its delivery system
to enhance Cannabidiol (“CBD”) transport to the brain. CBD acts on CB receptors of the endocannabinoid system in the brain,
which regulates neuronal excitability response relevant to the pathophysiology of epilepsy. NobrXiol uses a proprietary preassembled
delivery device that holds single-use cartridges that are sealed in inert gas and pressurized for easy activation that can be self-administered.
Activation of the cartridge propels the CBD powder formulation into the nose and to the brain via the olfactory nerve/bulb. This product
candidate will be formulated to potentially treat epileptic seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome
(DS) in pediatric patients two years of age and older. Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) are rare central nervous
system diseases considered serious epileptic encephalopathies that cause different types of epileptic seizures, as well as cognitive
and behavioral changes, and are generally resistant to treatment. The FDA previously granted Orphan Drug Designation for another drug
for the treatment of the same diseases. Therefore, NobrXiol may also be able to receive Orphan Drug Designation for the treatment of
Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in pediatric patients. NobrXiol has many potential competitive advantages including
fast onset of action, reduced peripheral side effects, no liver first-pass metabolism, avoidance of drug to drug interactions, no gastrointestinal
interaction, and the potential to eliminate enzymatic deactivation. On September 17, 2021, we entered into a collaboration and license
agreement with Nanomerics (the “Nanomerics License Agreement – NobrXiol”) for the exclusive worldwide license to develop
and commercialize the product candidate. We plan to target our marketing and selling efforts to healthcare practitioners specializing
in pediatric epilepsy within the $16.915 billion market for managing epilepsy in pediatrics. We have engaged Destum Partners to search
for a Global Animal Healthcare sublicensing partner.
On April 21, 2022, we notified Nanomerics that
the study aim of demonstrating the ability of Nanomerics platform technology delivering CBD to the brain via nasal administration in
an animal model was met. Pursuant to the Nanomerics License Agreement - NobrXiol, we paid a milestone payment of $500,000 upon meeting
this study aim in April 2022. We submitted the pre-IND Briefing Book with the FDA in October 2022 and received comments back from the
FDA in December 2022. Upon our review of the FDA minutes, we now believe we have the appropriate guidance from the FDA to move forward
with our overall development plan for this new product candidate and the ability to identify any need for further data prior to submitting
the IND. Our current plan is to utilize potential grant awards to fund the development of NobrXiol through to an IND filing. In April
2023, we entered into a participation agreement with the National Institute of Neurological Disorders and Stroke (“NINDS”),
a part of NIH, to supply our product candidate compounds to the NINDS’s Epilepsy Therapy Screening Program (“ETSP”).
NINDS ETSP will test our compounds in epilepsy animal models to determine whether our compounds have activity against resistant epilepsy
and related disorders.
Current Development Status
An acute seizure model study, Maximal Electroshock
Seizures (MES) in rats, is currently ongoing at NINDS ETSP. Once that study is complete, NINDS plans to explore behavioral tolerability
screens, and chronic seizure models. There are also plans to examine the differentiation with various models for acute and sub-chronic
dosing and to explore ancillary drug resistant epilepsy models.
Diclofenac Epolamine Spray Film (Epoladerm™)
We believe the Topical Spray Film Delivery Technology,
which we refer to as Epoladerm™, could provide a pathway for additional proprietary spray formulations with strong adhesion and
accessibility properties upon application, especially around active joints and contoured body surfaces to manage pain associated with
osteoarthritis. Osteoarthritis, which we believe to be a significant global market opportunity for us, is a painful condition that results
in reduced physical function and quality of life and increased risk of all-cause mortality. On June 6, 2017, the Company entered into
a license agreement, as amended on September 2, 2017 and October 31, 2017 (the “MedPharm License Agreement”), with MedPharm
Limited (“MedPharm”) for the exclusive global rights to discover, develop, make, sell, market, and otherwise commercialize
any pharmaceutical composition or preparation (in any and all dosage forms) in final form containing one or more compounds, including
Diclofenac Epolamine (“Epoladerm”), that was developed, manufactured or commercialized utilizing MedPharm’s spray formulation
technology (“MedPharm Product”), to be used for any and all uses in humans (including all diagnostic, therapeutic and preventative
uses).
Image 7, below, displays the expected delivery
system of Epoladerm for the treatment of chronic osteoarthritis:
Image 7
When discussing nonopioid treatments for chronic
pain, the Centers for Disease Control (“CDC”) notes clinicians should consider topical agents as alternative first-line analgesics,
thought to be safer than systemic medications. In an August 18, 2020 article appearing in the Annals of Internal Medicine, the American
College of Physicians and the American Academy of Family Physicians announced a joint clinical guideline, “Nonpharmacologic and
Pharmacologic Management of Acute Pain from Non-Low Back, Musculoskeletal Injuries in Adults,” whereby they recommend topical NSAIDs
as first-line therapy for patients experiencing pain from non-low back, musculoskeletal injuries. The clinical guideline also recommends
that clinicians not prescribe opioids for these injuries except in cases of severe injury or if patients cannot tolerate first-line therapeutic
options. A recent large meta-analysis research report published in October 2021 on pharmacologic treatments for knee and hip osteoarthritis
indicated that topical diclofenac had the largest effect on pain and physical function with a better safety profile than oral diclofenac.
Based on this meta-analysis it was recommended that topical diclofenac should be considered as a first-line pharmacological treatment
for knee osteoarthritis.
As a result of our pre-investigational new drug
(“IND”) meeting, we believe it is reasonable for us to pursue a 505(b)(2) or OTC accelerated new drug application (“NDA”)
for Epoladerm. There can be no assurance that we will be successful in securing regulatory approval under the 505(b)(2) pathway or that
we will be successful in mitigating risks associated with the clinical development of this product candidate.
Current Development Status
In December 2021, we completed a single dose
pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the required IND enabling trials. Single-dose transdermal
delivery of Epoladerm was well-tolerated in all minipigs and no treatment-related clinical observations, changes in body weight, or dermal
irritation were observed. All Epoladerm treated animals had plasma levels of Epoladerm confirming transdermal absorption. The maximum
plasma concentration (“Cmax”) was reached at 4 hours post-dose, and plasma Epoladerm remained at 24-hour post-dose for all
animals.
In January 2022, we reported positive results
of four preclinical dermal safety studies for Epoladerm. Researchers concluded that once daily dermal administration of Epoladerm for
28 days was well-tolerated with no serious adverse findings. The studies included a skin irritation study in rabbits; a dermal sensitization
assessment in guinea pigs; and a phototoxicity assay in mouse fibroblasts. Epoladerm was well tolerated in each of the studies and no
reportable dermal irritation, dermal sensitization or phototoxicity was observed.
In June 2022, we announced our intention to pursue
a direct to Over-the-Counter (“OTC”) regulatory pathway for Epoladerm. The direct to OTC, non-prescription regulatory pathway
is expected to provide a faster drug development timeline and faster global approval track than the prescription pathway we had originally
pursued for Epoladerm. To support the OTC application, Epoladerm’s completed dermal toxicity, sensitization, irritation, phototoxicity
studies and its pharmacokinetic characteristics will need to be submitted to the FDA. In addition, we will have to complete a consumer
preference assessment and a pivotal study required by the FDA’s Office of Non-prescription Drugs. The originally scheduled preclinical
toxicology studies for an osteoarthritis of the knee indication that were to run in parallel with our anticipated pilot study for Epoladerm
will not be required for our direct to OTC regulatory pathway.
We made the determination to delay our First-in-Human
study investigating Epoladerm for pain associated with chronic osteoarthritis due to: (i) a delay in procuring the active pharmaceutical
ingredient necessary for the drug product candidate, (ii) delays related to supply chain disruptions, and (iii) an extensive review of
the formulation and potential degradants resulting in MedPharm replacing the potential degradant. Additional formulation work and in-vitro
permeation testing may enable the patent coverage of this asset to be extended until at least 2042 and provide an Over the Counter (“OTC”)
pathway. MedPharm is anticipated to complete the formulation work and permeation testing in the first half of 2024.
We are seeking to license out or partner this
asset as we continue to focus our efforts on our prescription drug pipeline.
High-Density Molecular Masking Spray Formulation
for the Prevention of Respiratory Viruses (AnQlar™)
AnQlar is a high-density molecular masking spray
we plan to develop as an anti-viral barrier to potentially prevent, or reduce the risk or the intensity of, viral infections in humans.
We intend for this formulation to be delivered using a metered dose nasal spray to propel the high-density molecular formulation into
the nose and potentially prevent viral binding to epithelial cells in the nasal cavity and the upper respiratory tract, potentially reducing
respiratory related infections.
AnQlar could potentially be marketed to first
responders, healthcare workers, clinics, military forces, transplant and other immune compromised or at risk patients within the $13
billion (as of 2019) anti-viral market.
Image 8 below illustrates the results of the AnQlar
IND-enabling toxicology studies ex-vivo:
Image 8
A lower viral yield was detected in the cultures
treated with AnQlar than in the control with Phosphate Buffered Saline (“PBS”) after 72 hours of infection.
Current Development Status
We submitted and received a written pre-investigational
new drug (“pre-IND”) response from the FDA for AnQlar. In its pre-IND response, the FDA provided guidance on our pathway
to pursue prophylactic treatment against SARS-CoV-2 and influenza for daily use as an OTC product. We believe the results of the pre-IND
response support further research on AnQlar as a once daily intranasal prophylactic treatment of viral infections. The FDA has indicated
that, upon successful completion of all necessary preclinical and clinical trials, we may pursue an NDA drug approval with the Office
of Non-Prescription Drugs.
In August 2021, we engaged Syneos Health to assist
with the design of the optimal clinical trial to facilitate an efficient regulatory and development timeline for AnQlar.
On August 25, 2021, we entered into a commercial
manufacturing and supply agreement with Seqens, an integrated global leader in pharmaceutical solutions with 24 manufacturing sites worldwide
and seven research and development facilities throughout the U.S. and Europe. The agreement with Seqens provides for both the supply
material for our clinical studies as well as the long-term commercial supply of AnQlar.
On September 29, 2021,
we engaged a research and development firm to conduct a series of IND enabling toxicity studies for AnQlar. These studies have been completed
without an analysis of the pharmacokinetics (PK) data.
On July 5, 2022, we
announced our intention to pursue an OTC Intranasal Medical Device Consumer regulatory pathway for AnQlar. The FDA has indicated
that, upon successful completion of all necessary preclinical and clinical trials, we may pursue an NDA drug approval with the Office
of Non-Prescription Drugs.
On July 27, 2022, Virpax conducted an initial review
of the results from a preclinical virology study evaluating the viral barrier properties of AnQlar™ versus two variants of the SARS
CoV-2 virus. This review conducted by our external consultants indicates that the test article (AnQlar) shows an appropriate level
of virus deactivation for a prophylactic viral barrier product candidate which was the outcome we were expecting. We have completed a
validated bioanalytical method for the samples on February 12, 2024.
We are seeking to license out or partner this
asset as we continue to focus our efforts on our prescription drug pipeline.
Intellectual Property
We strive to protect and enhance the proprietary
technologies, inventions and improvements that we believe are important to our business, including seeking, maintaining and defending
patent rights, whether developed internally or licensed from third parties. Our policy is to seek to protect our proprietary position
by, among other methods, pursuing and obtaining patent protection in the United States and in jurisdictions outside of the United States
related to our proprietary technology, inventions, improvements, platforms and our product candidates that are important to the development
and implementation of our business.
As of March 15, 2024 our portfolio of owned and licensed patents and
pending patent applications consisting of 27 issued patents of which 11 are issued U.S. patents, 13 pending patent applications, of which
3 are pending U.S. patent applications, 1 pending Patent Cooperation Treaty (“PCT”) application, and 2 provisional patent
applications. These patent rights include issued US Patent Nos. 7,741,474, 8,470,371, 10,213,474, 8,278,277, 8,920,819, 9,713,591, 8,349,297
8,695,592, 10.213.474, 10,842,745 and 11,839685 as well as patents and patent applications in Europe (Germany, France, UK), Canada, Japan,
China, Israel, Australia, New Zealand, and South Korea. Below is a breakdown of patents by product, with unextended patent expiration
dates indicated:
Epoladerm
The product candidate is covered by US Patent
No. 8,349,297 (expires December 4, 2028) as well as issued patents in South Africa, Russian Federation, New Zealand, Norway, Mexico,
Republic of Korea, Japan, China, Canada, Australia, Turkey, Slovakia, Slovenia, Sweden, Portugal, Poland, Netherlands, Latvia, Luxembourg,
Lithuania, Italy, Ireland, Hungary, Greece, United Kingdom, France, Finland, Spain, Denmark, Germany, Czech Republic, Switzerland, Belgium
and Austria (all of which expire September 14, 2026). The patents contain broad composition claims to a platform of pharmaceutical formulations
which form a film on spray administration where the active agent is present at least 80% saturation and there is no undissolved active
agent in the formulation. The claims also include a method of treatment and an aerosol dispenser containing the formulation. There is
one pending provisional patent application that relates to specific spray formulations of diclofenac.
Probudur
The product candidate is covered by US Patent
No. 9,713,591 (expires July 24, 2030) and US Patent No. 10,842,745 and 11,839685 (expires October 10, 2029) as well as a European patent
(expires October 11, 2029) and a Chinese patent (expires October 11, 2029). There is also a pending US application which is a continuation
of US Patent No. 11,839685. The patents contain composition claims to pharmaceutical compositions having an external storage solution
containing an active pharmaceutical ingredient and particles of liposomes embedded in a polymeric matrix contained within the storage
solution.
Envelta
The product candidate is covered by the following
patent families which protect the chemistry of the MET polymer and its use in pharmaceutical products: Patent Family 1 includes US Patent
No. 7,741,474 (expires March 18, 2026). This patent family covers carbohydrate polymers with hydrophobic and hydrophilic side-groups
suitable for solubilizing, for example, hydrophobic drugs.
Patent Family 2 includes US Patent No. 8,470,371
(expires July 29, 2029) and a Japanese Patent (expires August 8, 2027) and a European Patent (which expires August 8, 2027). This family
covers both composition and method claims for amphiphilic carbohydrate polymers which are capable of self-assembling to form micellar
clusters in which the carbohydrate amphiphiles aggregate into hierarchically organized micellar clusters of individual aggregates. These
micellar clusters formed by the aggregation of individual micelles may be transformed into stable nanoparticles with drugs, especially
hydrophobic drugs that have poor aqueous solubility. This provides molar polymer/drug ratios that are greater than the ratios observed
with block copolymers and improve the transfer of hydrophobic drugs across biological barriers.
Patent Family 3 includes US Patent Nos. 8,278,277 (expires August 16,
2030) and 8,920,819 (expires April 29, 2029), a Canadian patent (expires March 1, 2030) and a European patent (expires March 1, 2030).
This family covers lipophilic derivatives of hydrophilic drugs comprising a hydrophilic drug and a cleavable linker as well as methods
of treatment using these compositions. In particular, the patents relate to compositions of a lipophilic derivative of the hydrophilic
neuropeptide Leucine [5]-Enkephalin and an amphiphile compound, where the derivative includes a lipophilic linker attached to the side
chain oxygen of the tyrosine in the Leucine [5]-Enkephalin, and where the amphiphile compound is quaternary palmitoyl glycol chitosan
(GCPQ).
Patent Family 4 includes US Patent No. 10,213,474
(expires November 3, 2034), a Japanese patent (expires November 3, 2034), a European patent (expires November 3, 2034) and a Canadian
patent (expires November 3, 2034). The patents cover methods for treating pain, comprising intranasally administering to a human or animal
a composition comprising a therapeutically effective amount of a hydrophilic neuroactive peptide and an amphiphilic quaternary ammonium
palmitoyl glycol chitosan (GCPQ); wherein the amphiphilic GCPQ is capable of self-assembly in aqueous media into particles having a mean
particle size between 20-500 nm; where intranasally administering the composition delivers the hydrophilic neuroactive peptide to the
brain of the human or animal.
Patent Family 5 includes national phase filings
of WO 2021/1234413 which includes patent applications in the United States, Canada, Europe, Japan, and China. These patent applications
cover acetylated amphiphilic carbohydrate compounds of average molecular weight 1-50 kDa which is based on a glycol chitosan, wherein
the levels of acetylation can be modified. The compound can be formulated with hydrophobic compounds where the degree of acetylation
of the carbohydrate compound is optimized to maximize solubilization of the compounds.
Patent Family 6 comprises US Provisional Patent
Application No. 63/524764 which covers delivering leucine-5-enkephalin encapsulated in GCPQ intranasally via a drug or medicine dispersion
and delivery system. Patents from this provisional application, if issued, would expire in 2044.
In addition to the patent families which protect
the chemistry of the MET polymer and its use in pharmaceutical products there is a patent family which covers the delivery device that
can be used to administer the pharmaceutical compositions including US Patent No. 8,695,592 (expires October 11, 2029), and a European
patent (expires October 11, 2029). This family covers a capsule for use in dispensing a drug which has a pressurized container for a
fluid, a chamber for containing a particulate, at least one channel running between the container and the chamber to provide fluidic
communication and at least two distinct concave surfaces which impart rotational motion to a fluid flow so that within the chamber a
rotationally turbulent flow of fluid is produced in order to engage with the particulate and to produce a mobile fluid comprising the
particulate.
AnQlar
This product candidate is specifically covered
by a PCT application WO 2022/043678A1 by a family of patent applications (United States, Canada, Japan, China, Europe and Australia)
which describes a molecular masking spray for use as an anti-viral barrier to potentially prevent, or reduce the risk or the intensity
of, viral infections in humans. Depending on the formulation and mode of administration of AnQlar, the product candidate may also be
covered by many of the patents and patent application which cover Envelta.
NobrXiol
This product candidate is specifically covered
by a PCT patent application which describes compositions containing an amphiphilic carbohydrate compound and a cannabinoid which may
be intranasally delivered. Depending on the formulation and of NobrXiol, the product candidate may also be covered by many of the patents
and patent application which cover Envelta.
Individual patents extend for varying periods depending on the date
of filing of the patent application 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 portion of the U.S. Patent and Trademark Office,
or USPTO, delay 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 filing date. Many foreign jurisdictions also offer patent term extensions
based on regulatory delays. 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.
Furthermore, we rely upon trade secrets and know-how
and continuing technological innovation to develop and maintain our competitive position. We seek to protect our proprietary information,
in part, using confidentiality agreements with our collaborators, employees, contractors, consultants and advisors and invention assignment
agreements with our employees. We also have confidentiality agreements or invention assignment agreements with our collaborators, contractors
and selected consultants. These agreements are designed to protect our proprietary information and, in the case of the invention assignment
agreements, to grant us ownership of technologies that are developed through a relationship with a third party. These agreements may
be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently
discovered by competitors. To the extent that our collaborators, employees, contractors and consultants use intellectual property owned
by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
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, or our drugs 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 drugs may have an adverse impact on us. If third parties have prepared and filed patent applications prior to the date of
our earliest filed patent applications in the United States that also claim technology to which we have rights, we may have to participate
in interference proceedings in the USPTO, to determine priority of invention. For more information, please see “Risk Factors —
Risks Related to Our Intellectual Property.”
Material Agreements
MedPharm Limited
Research and Option Agreement
On April 11, 2017, we entered into a research
and option agreement, as amended on May 30, 2018 (the “MedPharm Research and Option Agreement”), with MedPharm Limited, a
company organized and existing under the laws of the United Kingdom (“MedPharm”), pursuant to which MedPharm granted
us an option to obtain an exclusive, world-wide, royalty bearing license to use certain technology developed by MedPharm. Pursuant to
the agreement, MedPharm will conduct certain research and development of proprietary formulations incorporating certain MedPharm technologies
and certain of our proprietary molecules.
Under the MedPharm Research and Option Agreement,
MedPharm granted us an option (the “MedPharm Option”) to obtain an exclusive (even to MedPharm), worldwide, sub-licensable
(through multiple tiers), royalty bearing, irrevocable license to research, develop, market, commercialize, and sell any product utilizing
MedPharm’s spray formulation technology which is the result of the activities performed under the MedPharm Research and Option
Agreement, subject to our entry into a definitive license agreement with MedPharm. In order to exercise the MedPharm Option, we must
provide MedPharm with written notice of such exercise before the end of the Option Period (as defined in the MedPharm Research and Option
Agreement). The Option Period is subject to extension upon our mutual agreement with MedPharm.
Pursuant to the MedPharm Research and Option
Agreement, we have a right of first refusal with respect to any license or commercial arrangement involving any Licensed Intellectual
Property (as defined in the MedPharm Research and Option Agreement) in combination with any Virpax Molecule (as defined in the MedPharm
Research and Option Agreement). In the event that MedPharm reaches an agreement with respect to a license or other commercial arrangement
that involves technology or molecules covered by the right of first refusal, we have ten business days from the date of notice to notify
MedPharm of our intention to exercise the right of first refusal and our intention to match the financial terms of the other license
or commercial arrangement.
License Agreement (Epoladerm)
On June 6, 2017, as a result of the Company’s
exercise of the MedPharm Option under the MedPharm Research and Option Agreement, the Company entered into a license agreement, as amended
on September 2, 2017 and October 31, 2017 (the “MedPharm License Agreement”), with MedPharm for the exclusive global rights
to discover, develop, make, sell, market, and otherwise commercialize any pharmaceutical composition or preparation (in any and all dosage
forms) in final form containing one or more compounds, including Diclofenac Epolamine (“Epoladerm”), that was developed, manufactured
or commercialized utilizing MedPharm’s spray formulation technology (“MedPharm Product”), to be used for any and all
uses in humans (including all diagnostic, therapeutic and preventative uses). Under the MedPharm License Agreement, the Company is required
to make future milestone and royalty payments to MedPharm. The Company is obligated to make aggregate milestone payments to MedPharm
of up to GBP 1.150 million upon the achievement of specified development milestones (payable in Great British Pounds). Additional milestone
payments are due upon the achievement of certain development and commercial milestones achieved outside the United States, payable on
a country-by-country basis. Royalty payments must be paid to MedPharm in an amount equal to a single-digit percentage of net sales of
all MedPharm Product sold by us during the royalty term in the territory. Royalties shall be payable, on a country-by-country basis,
during the period of time commencing on the first commercial sale and ending upon the expiration of the last-to-expire patent claim on
the licensed product, which is set to expire on December 4, 2028. Each party has the right to terminate the agreement in its entirety
upon written notice to the other party if (a) such other party is in material breach of the agreement and has not cured such breach within
ninety (90) days after notice from the terminating party indicating the nature of such breach or (b) if the other party is dissolved
or liquidated or takes any corporate action for such purpose; makes a general assignment for the benefit of creditors; or has a receiver,
trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material
portion of its property or business. We have the right to terminate the agreement on a country by country basis for any reason
or for no reason at any time upon ninety (90) days’ prior written notice to MedPharm and MedPharm has the right to terminate
the agreement if we commence any interference or opposition proceeding with respect to, challenge the validity or enforceability of,
or oppose any extension of term or the MedPharm Patent Rights (as such term is defined in the agreement) or we acquire or develop a Generic
Version(as such term is defined in the agreement) of a MedPharm Product.
LipoCureRX, Ltd. (Probudur)
On March 19, 2018, we entered into a license
and sublicense agreement (the “LipoCure Agreement”) with LipoCureRX, Ltd., a company organized and existing under the laws
of Israel (“LipoCure”), for the sole and exclusive global license and sub-license rights to discover, develop, make, sell,
market, and otherwise commercialize bupivacaine liposome, in injectable gel or suspension (“Licensed Compound”) or any pharmaceutical
composition or preparation (in any and all dosage forms) in final form, including any combination product, containing a Licensed Compound
(“Licensed Product”), including Probudur. Under the LipoCure Agreement, we were required to pay an upfront fee upon signing
of $150,000 and are required to make future milestone and royalty payments to LipoCure. We are obligated to make aggregate milestone
payments of up to $19.8 million upon the achievement of specified development and commercial milestones. Royalty payments must be paid
in an amount equal to a single digit to low double-digit percentage of annual net sales of royalty qualifying products, subject to certain
adjustments. Royalties shall be payable during the period of time, on a country-by-country basis, commencing on the first commercial
sale and ending upon the expiration of the last-to-expire patent claim on the licensed product, which is set to expire on July 24, 2030.
Each party has the right to terminate the agreement in its entirety upon written notice to the other party (a) if such other party is
in material breach of the agreement and has not cured such breach within ninety (90) days after notice from the terminating party indicating
the nature of such breach or (b) with immediate effect if such other party passes a resolution for voluntary winding up or a winding
up application is made against it and not set aside within 60 days; or (ii) a receiver of a liquidator is appointed for the other party;
or (iii) the other party enters into winding up or insolvency or bankruptcy proceedings; or (iv) the other party enters into a scheme
or arrangement in contemplation of the foregoing with its creditors.
Nanomerics Ltd.
Nanomerics Collaboration Agreement (Envelta)
On April 11, 2019, we entered into an exclusive
collaboration and license agreement, as amended (the “Nanomerics Collaboration Agreement”), with Nanomerics Ltd. (“Nanomerics”),
a company organized and existing under the laws of United Kingdom, for the exclusive world-wide license to develop and commercialize
products, including Envelta, which contain hydrophilic neuropeptide Leucin5-Enkephalin and an amphiphile compound which is quaternary
ammonium palmitoyl glycol chitosan, and to engage in a collaborative program utilizing Nanomerics’ knowledge, skills and expertise
in the clinical development of products and in attracting external funding for such development. The Nanomerics Collaboration Agreement
was also amended to include a program for the pre-clinical development of a product for post-traumatic stress disorder.
Under the Nanomerics Collaboration Agreement,
we are required to make royalty payments equal to a single digit percentage of annual net sales of royalty qualifying products. We are
also required to make aggregate milestone payments of up to $103 million upon the achievement of specified development and commercial
milestones, and sublicense fees for any sublicense relationships we enter into subsequent to the Nanomerics Collaboration Agreement.
Our obligation to pay royalties, on a country-by-country basis, shall commence on the date of first commercial sale of our licensed products
and shall expire with respect to each separate licensed product, on the latest to occur of (a) the tenth (10th) anniversary
of the first commercial sale of the first licensed product; (b) the expiration date of the last to expire of any valid claim (patent
is set to expire on November 3, 2034); and, (c) the date upon which a generic product has been on the market for a period of no fewer
than ninety (90) days. We have the right to terminate the agreement upon 180 days’ prior written notice to Nanomerics. Upon
termination, we shall assign to Nanomerics all its right title and interest in all results other than results specific to (a) the
Device (as defined in the Nanomerics Collaboration Agreement), its manufacture or use; and (b) the Technology, but excluding any
clinical results relating to the Compound or Licensed Products (all terms as defined in the Nanomerics Collaboration Agreement).
Nanomerics License Agreement (AnQlar)
On August 7, 2020, we entered into a collaboration
and license agreement with Nanomerics (the “Nanomerics License Agreement”) for the exclusive North American license to develop
and commercialize a High-Density Molecular Masking Spray (AnQlar) as an anti-viral barrier to prevent or reduce the risk or the intensity
of viral infections in humans. Under the Nanomerics License Agreement, we were required to make royalty payments and milestone payments
upon the achievement of specified development and commercial milestones, and sublicense fees for any sublicense relationships we enter
into subsequent to the Nanomerics License Agreement (any patent that issues from the currently filed provisional patent application would
expire on August 24, 2041).
On March 9, 2022, we entered into an Amended
and Restated Collaboration and License Agreement with Nanomerics (the “Amended Nanomerics License Agreement”) which amended
and restated the August 7, 2020, Nanomerics License Agreement and expanded our North American rights for AnQlar to include exclusive
global rights to develop and commercialize AnQlar as an anti-viral barrier to prevent or reduce the risk or the intensity of viral infections.
The Amended Nanomerics License Agreement provides for payments up to $5.5 million upon the achievement of specified development milestones
and profit share payments equal to between 30% to 40% of certain profits (as set forth in the Amended Nanomerics License Agreement),
payable to Nanomerics upon the achievement of specified commercial milestones. The profit share payments are triggered upon determination
by the FDA that AnQlar may be marketed as an Over-the-Counter product in the United States. In the event the profit share payments are
not triggered as defined above, we would be obligated to pay royalties within a range of 5% to 15% of annual net sales of royalty qualifying
products and commercial milestones on a worldwide basis amounting to aggregate milestone payments of up to $112.5 million upon the achievement
of these commercial milestones. The Amended Nanomerics License Agreement also provides for additional aggregate milestone payments totaling
$999,999 upon first receipt of regulatory approval for a licensed product in the European Union, Asia/Pacific region and South America/Middle
East region. The Company’s obligation to pay royalties, on a country-by-country basis, shall commence on the date of first commercial
sale of its licensed products and shall expire with respect to each separate licensed product, on the latest to occur of (a) the tenth
(10th) anniversary of the first commercial sale of the first licensed product; (b) the expiration date of the last to expire of any valid
claim; and, (c) the date upon which a generic product has been on the market for a period of no fewer than ninety (90) days. The Company
has the right to terminate the Nanomerics License Agreement upon sixty (60) days’ prior written notice to Nanomerics. Each party
has the right to terminate the agreement in its entirety upon written notice to the other party (a) if such other party is in material
breach of the agreement and has not cured such breach within ninety (90) days after notice from the terminating party indicating the
nature of such breach or (b) in the event that the other party shall file in any court or agency, pursuant to any statute or regulation
of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an the appointment of a receiver or trustee
of such other Party or of its assets, or if the other Party proposes a written agreement of composition or extension of its debts of
its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, or if the
other Party shall propose or be a party to any dissolution or liquidation, or if the other Party shall make an assignment for the benefit
of its creditors. Upon termination, the Company shall assign to Nanomerics all its rights, title and interest in all of its results.
Nanomerics has the right to terminate the agreement upon sixty (60) days’ prior written notice. In consideration for entering into
this Amended Nanomerics License Agreement, the Company paid Nanomerics $1,500,000 during the year ended December 31, 2022.
Nanomerics License Agreement (NobrXiol)
On September 17, 2021, we entered into a collaboration
and license agreement with Nanomerics (the “Nanomerics License Agreement - NobrXiol”) for the exclusive worldwide license
to develop and commercialize an investigational formulation delivered via the nasal route to enhance pharmaceutical-grade cannabidiol
(“CBD”) transport to the brain to potentially treat seizures associated with tuberous sclerosis complex (“TSC”),
Lennox-Gastaut syndrome and Dravet syndrome in patients one year of age and older. Under the Nanomerics License Agreement – NobrXiol,
we are required to make royalty payments within a range of 5% to 15% of annual net sales of royalty qualifying products. Our obligation
to pay royalties, on a country-by-country basis, shall commence on the date of first commercial sale of licensed products (as defined
in the Nanomerics License Agreement – NobrXiol) and shall expire with respect to each separate licensed product, on the latest
to occur of (a) the fifteen (15th) anniversary of the first commercial sale of the first licensed product; (b) the expiration date of
the last to expire of any valid claim; and, (c) the date upon which a generic product has been on the market for a period of no fewer
than ninety (90) days. We paid an upfront milestone payment upon signing of $200,000 and are required to make future milestone and royalty
payments of up to $41 million upon the achievement of specified development and commercial milestones, and sublicense fees for any sublicense
relationships we enter into subsequent to the Nanomerics License Agreement – NobrXiol (any patent that issues from the currently
filed PCT patent application would expire on September 9, 2043). We have the right to terminate the Nanomerics License Agreement –
NobrXiol upon one hundred and eighty (180) days’ prior written notice to Nanomerics. Upon termination, we shall assign to Nanomerics
all its rights, title and interest in all of its results. Nanomerics has the right to terminate the agreement upon thirty (30) days’
prior written notice if we conclude in writing to Nanomerics that the study aim has not been achieved or we notify Nanomerics that we
have decided against proceeding with a Phase 3 Clinical trial.
On April 21, 2022, the Company notified Nanomerics
that the study aim of demonstrating the ability of Nanomerics platform technology delivering CBD to the brain via nasal administration
in an animal model was met. Pursuant to the Nanomerics License Agreement - NobrXiol, the Company paid and incurred a milestone payment
of $500,000 upon meeting this study aim in April 2022.
Sales and Marketing
If Epoladerm, Probudur, Envelta, AnQlar and/or
NobrXiol are approved, we plan to enter into sales and marketing agreements with one or several pharmaceutical companies to sell to pain
management clinics and specialists, general and orthopedic surgeons, anesthesiologists, primary care physicians (“PCPs”),
Nurse Practitioners (“NPs”), oncologists, and neurologists.
On August 30, 2018, we entered into a Master
Service Agreement (the “MSA”) with INC Research, LLC, a Syneos Health™ group company (“Syneos Health”)
to operate as our Contract Sales Organization (“CSO”). Services provided by Syneos Health include clinical research services,
bioanalytical analysis, statistics, validations, pharmacokinetics, and/or consulting, advertising, and public relations (communications),
field team sales and education recruiting and deployment, and patient adherence services.
Manufacturing
We rely on third-party contractors for manufacturing
clinical supplies and plan to do so for commercial amounts also.
We continue to explore manufacturing sources,
in order to ensure that we have access to sufficient manufacturing capacity in order to meet potential demand for any of our product
candidates in a cost-efficient manner. We plan to secure supply sources and contract with these or other parties to manufacture commercial
quantities of any products we successfully develop. Among the conditions for FDA approval of a pharmaceutical product is the requirement
that the manufacturer’s quality control and manufacturing procedures conform to cGMP, which must be followed at all times. The
FDA typically inspects manufacturing facilities on an ongoing basis. In complying with Current Good Manufacturing Practice (“cGMP”)
regulations, pharmaceutical manufacturers must expend resources and time to ensure compliance with product specifications as well as
production, record keeping, quality control, reporting, and other requirements.
Competition
The pharmaceutical industry is intensely competitive
and subject to rapid and significant technological change. We will continue to face competition from various global pharmaceutical, biotechnology,
specialty pharmaceutical and generic drug companies that engage in drug development activities. Many of our competitors have similar
products that focus on the same diseases and conditions that our current and future pipeline product candidates address. Many of our
competitors have greater financial flexibility to deploy capital in certain areas as well as more commercial and other resources, marketing
and manufacturing organizations, and larger research and development staff. As a result, these companies may be able to pursue strategies
or approvals that we are not able to finance or otherwise pursue and may receive FDA, or other applicable regulatory approvals more efficiently
or rapidly than us. Also, our competitors may have more experience in marketing and selling their products post-approval and gaining
market acceptance more quickly. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large, established companies. Our product candidates could become less competitive if our competitors are able to license
or acquire technology that is more effective or less costly and thereby offer an improved or a cheaper alternative to our product candidates.
We expect any product candidates that we develop
and commercialize will compete on the basis of, among other things, efficacy, safety, convenience of administration and delivery, price
and the availability of reimbursement from government and other third-party payors. We also expect to face competition in our efforts
to identify appropriate collaborators or partners to help commercialize our product candidate portfolio in our target commercial markets.
Government Regulation and Approval Process
Government authorities in the United States
at the federal, state and local level, including the FDA, the FTC and the DEA, extensively regulate, among other things, the research,
development, testing, manufacture, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising, distribution,
marketing and export and import of products such as those we market. For both currently marketed and future products, failure to comply
with applicable regulatory requirements can, among other things, result in suspension of regulatory approval and possible civil and criminal
sanctions. Regulations, enforcement positions, statutes and legal interpretations applicable to the pharmaceutical industry are constantly
evolving and are not always clear. Significant changes in regulations, enforcement positions, statutes and legal interpretations could
have a material adverse effect on our financial condition and results of operations.
Additionally, future healthcare legislation or
other legislative proposals at the federal and state levels could bring about major changes in the affected health care systems, including
statutory restrictions on the means that can be employed by brand and generic pharmaceutical companies to settle Paragraph IV patent
litigations. We cannot predict the outcome of such initiatives, but such initiatives, if passed, could result in significant costs to
us in terms of costs of compliance and penalties associated with failure to comply.
Law enforcement and regulatory agencies may apply
policies that seek to limit the availability of opioids. This creates the potential for aggressive enforcement, unfavorable publicity
regarding the use or misuse of opioid drugs or the limitations of abuse-deterrent formulations, litigation, public inquiries or investigations
related to the abuse, sales, marketing, distribution or storage of opioid products.
In addition, efforts by the FDA and other regulatory
bodies to combat the abuse of opioids will positively impact the market for our novel non-opioid and non-addictive product candidates.
We expect that the FDA will continue to evaluate the impact of abuse-deterrent opioids in the future, and this could impose further restrictions
to opioid products currently on the market, which may include changing labeling, imposing additional prescribing restrictions, or seeking
a product’s removal from the market.
Coinciding with Helping to End Addiction Long
Term (HEAL), a NIH initiative, there is new FDA guidance that are part of a larger effort to reduce the use of opioid analgesic drugs.
The first guidance, issued in June 2019, focuses on assessing the benefits and risks of developing new opioid pain drugs, including an
updated framework for evaluating the risks associated with intentional or illicit misuse or abuse of these substances. In connection
with the SUPPORT for Patients and Communities Act (SUPPORT Act), the purpose of this guidance is to spur the development of alternatives
to opioids for the management of acute pain by providing information about product development-related issues, “opioid-sparing”
claims, and expedited programs. The second guidance, issued in February 2022, addresses medications that can reduce the use of opioids
in the treatment of acute pain, including how sponsors can demonstrate a clinically meaningful reduction in the use of opioid pain medications
in the acute setting. The third guidance, issued March 2023, outlines a path for developing extended-release local anesthetics,”
including clinical pharmacology, proper evaluation of safety and efficacy, and the types of studies that may support approval of these
product candidates. Finally, FDA will issue guidance on the development of “new non-opioid pain medications for acute and chronic
pain that can provide therapeutic alternatives to the use of opioids.”
Pharmaceutical Regulation in the United States
In the United States, the FDA regulates
drugs under the FDCA and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with
appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.
Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after
approval may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve
pending applications, withdrawal of an approval, a clinical hold, Warning Letters, product recalls, product seizures, total or partial
suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or
criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.
FDA approval is required before any new unapproved
drug or dosage form, including a new use of a previously approved drug or a generic version of a previously approved drug, can be marketed
in the United States.
The process required by the FDA before a new
drug may be marketed in the United States generally involves:
| ● | Completion
of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s current GLP regulations; |
| ● | Submission
to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin in the United States; |
| ● | Approval
by an IRB at each clinical site before each trial may be initiated; |
| ● | Performance
of adequate and well-controlled human clinical trials in accordance with the FDA to establish the safety and efficacy of the proposed
drug product for each intended use; |
| ● | Satisfactory
completion of an FDA pre-approval inspection of the facility or facilities at which the product is manufactured to assess compliance
with the FDA’s cGMP regulations to assure that the facilities, methods and controls are adequate to preserve the drug’s identity,
strength, quality and purity; |
| ● | Submission
to the FDA of an NDA; |
| ● | Satisfactory
completion of a potential review by an FDA advisory committee, if applicable; and |
| ● | FDA
review and approval of the NDA. |
Preclinical Studies
When developing a branded product and bringing
it to market, the first step in proceeding to clinical studies is preclinical testing. Preclinical tests are intended to provide a laboratory
or animal study evaluation of the product to determine its chemistry, formulation and stability. Toxicology studies are also performed
to assess the potential safety of the product. The conduct of the preclinical tests must comply with federal regulations and requirements,
including GLPs. The results of these studies are submitted to the FDA as part of an IND application along with other information, including
information about product chemistry, manufacturing and controls and a proposed clinical trial protocol. Long-term preclinical tests,
such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND application is submitted.
Clinical Trials
Clinical trials involve the administration of
the investigational new drug to human subjects under the supervision of qualified investigators in accordance with GCP requirements,
which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical
trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be
used in monitoring safety, and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol
amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each institution participating in the clinical trial
must review and approve the plan for any clinical trial before it initiates at that institution. Information about certain clinical trials
must be submitted within specific timeframes to the NIH for public dissemination on their website, www.ClinicalTrials.gov.
Human clinical trials are typically conducted
in three sequential phases, which may overlap or be combined:
| ● | Phase
I: The drug is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety,
dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness. |
| ● | Phase
II: The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily
evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. |
| ● | Phase
III: The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled
clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the
overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product. |
Progress reports detailing the results of the
clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. Phase 1, Phase 2,
and Phase 3 trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the sponsor may
suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed
to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical
trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious
harm to patients.
Disclosure of Clinical Trial Information
Sponsors of certain clinical trials of FDA-regulated
products, including drugs, are required to register and disclose certain clinical trial information on www.ClinicalTrials.gov.
Information related to the product, subject population, phase of investigation, study sites and investigators, and other aspects of the
clinical trial is then made public as part of the registration. Sponsors are also obligated to discuss certain results of their clinical
trials after completion. Disclosure of the results of these trials can be delayed until the new product or new indication being studied
has been approved. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.
Marketing Approval
After completion of the required clinical testing,
an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the United States.
The NDA must include, among other things, the results of all preclinical, clinical and other testing and a compilation of data relating
to the product’s pharmacology, chemistry, manufacture and controls. Under federal law, the submission of most NDAs is subject to
a substantial application user fee, and the manufacturer or sponsor under an approved NDA is also subject to annual program fees. The
FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s
threshold determination that it is sufficiently complete to permit substantive review. The FDA may request additional information rather
than accept an NDA for filing. In this event, the NDA must be resubmitted with the additional information and is subject to payment of
additional user fees. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission
is accepted for filing, the FDA begins an in-depth substantive review. Under the Prescription Drug User Fee Act, as amended, the FDA
has agreed to certain performance goals in the review of NDAs through a two-tiered classification system, Standard Review and Priority
Review. Priority Review designation is given to drugs that are intended to treat a serious condition and, if approved, would provide
a significant improvement in safety or effectiveness over existing therapies. The FDA endeavors to review most applications subject to
Standard Review within ten to twelve months whereas the FDA’s goal is to review most Priority Review applications within six to
eight months, depending on whether the drug is a new molecular entity.
The FDA may refer applications for novel drug
products or drug products which present difficult questions of safety or efficacy to an advisory committee for review, evaluation and
recommendation as to whether the application should be approved and under what conditions. Before approving an NDA, the FDA may inspect
one or more clinical sites to assure compliance with GCP requirements. Additionally, the FDA will inspect the facility or the facilities
at which the drug is manufactured. The FDA will not approve the NDA unless it determines that the manufacturing process and facilities
are in compliance with cGMP requirements and are adequate to assure consistent production of the product within required specifications
and the NDA contains data that provide substantial evidence that the drug is safe and effective for the labeled indication.
After the FDA evaluates the NDA and the manufacturing
facilities, it issues either an approval letter or a complete response letter to indicate that the application is not ready for approval.
A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information,
in order for the FDA to reconsider the application. Even with submission of this additional information, the FDA may ultimately decide
that an application does not satisfy the regulatory criteria for approval. If, or when, the deficiencies have been addressed to the FDA’s
satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. An approval letter authorizes commercial marketing
of the drug with specific prescribing information for specific indications.
As a condition of NDA approval, the FDA may require
a REMS to help ensure that the benefits of the drug outweigh the potential risks. If the FDA determines a REMS is necessary during review
of the application, the drug sponsor must agree to the REMS plan at the time of approval. A REMS may be required to include various elements,
such as a medication guide or patient package insert, a communication plan to educate healthcare providers of the drug’s risks,
limitations on who may prescribe or dispense the drug, or other elements to assure safe use, such as special training or certification
for prescribing or dispensing, dispensing only under certain circumstances, special monitoring and the use of patient registries. In
addition, the REMS must include a timetable to periodically assess the strategy. The requirement for a REMS can materially affect the
potential market and profitability of a drug.
Moreover, as a condition of product approval,
the FDA may require substantial post-approval testing, known as Phase IV testing, and/or surveillance to monitor the drug’s
safety or efficacy, and the FDA has the authority to prevent or limit further marketing of a product based on the results of these post-marketing
programs. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or certain problems
are identified following initial marketing. Drugs may be marketed only for the approved indications and in accordance with the provisions
of the approved labeling, and, even if the FDA approves a product, it may limit the approved indications for use for the product or impose
other conditions, including labeling or distribution restrictions or other risk-management mechanisms.
Further changes to some of the conditions established
in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission
and FDA approval of a new NDA or NDA supplement before the change can be implemented, which may require us to develop additional data
or conduct additional preclinical studies and clinical trials. An NDA supplement for a new indication typically requires clinical data
similar to that in the original application, and the FDA uses the similar procedures in reviewing NDA supplements as it does in reviewing
NDAs.
Post-Approval Requirements
Once an NDA is approved, a product will be subject
to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to drug listing and registration,
recordkeeping, periodic safety reporting, product sampling and distribution, adverse event reporting and advertising, marketing and promotion,
including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational
activities and promotional activities involving the Internet. Drugs may be marketed only for the approved indications and in a manner
consistent with the provisions of the approved labeling. While physicians may prescribe for off-label uses, manufacturers may only promote
for the approved indications and in accordance with the provisions of the approved labeling. The FDA and other agencies actively enforce
the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label
uses may be subject to significant liability. There also are extensive DEA regulations applicable to controlled substances.
Adverse event reporting and submission of periodic
reports is also required following FDA approval of an NDA. Additionally, the FDA may place conditions on an approval, in addition to
REMS programs of Phase IV testing, that could restrict the distribution or use of the product. Drug manufacturers and certain of their
subcontractors are required to register their establishments and list their marketed products with the FDA and certain state agencies.
Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency inspects manufacturing
facilities to assess compliance with cGMPs. Accordingly, manufacturers must continue to expend time, money, and effort in the areas of
production and quality-control to maintain compliance with cGMPs, including quality control and manufacturing processes. Regulatory authorities
may withdraw product approvals or request product recalls if a company fails to comply with regulatory standards, if it encounters problems
following initial marketing or if previously unrecognized problems are subsequently discovered. The FDA may also impose a REMS requirement
on a drug already on the market if the FDA determines, based on new safety information, that a REMS is necessary to ensure that the drug’s
benefits outweigh its risks. In addition, regulatory authorities may take other enforcement action, including, among other things, Warning
Letters, the seizure of products, injunctions, consent decrees placing significant restrictions on or suspending manufacturing operations,
refusal to approve pending applications or supplements to approved applications, civil penalties and criminal prosecution.
The Hatch-Waxman Amendments
505(b)(2) NDAs
The FDA is authorized to approve an alternative
type of NDA under Section 505(b)(2) of the FDCA. Section 505(b)(2) permits the filing of an NDA where at least some of the
information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained
a right of reference from the data owner. The applicant may rely upon the FDA’s findings of safety and efficacy for an approved
product that acts as the “listed drug.” The FDA may also require 505(b)(2) applicants to perform additional studies or measurements
to support the change from the listed drug. The FDA may then approve the new product candidate for all, or some, of the conditions of
use for which the branded reference drug has been approved, or for a new condition of use sought by the 505(b)(2) applicant.
Abbreviated New Drug Applications (“ANDAs”)
The Hatch-Waxman amendments to the FDCA established
a statutory procedure for submission and FDA review and approval of ANDAs for generic versions of listed drugs. An ANDA is a comprehensive
submission that contains, among other things, data and information pertaining to the active pharmaceutical ingredient (“APII”),
drug product formulation, specifications and stability of the generic drug, as well as analytical methods, manufacturing process validation
data and quality control procedures. Premarket applications for generic drugs are termed abbreviated because they generally do not include
clinical data to demonstrate safety and effectiveness. However, a generic manufacturer is typically required to conduct bioequivalence
studies of its test product against the listed drug. Bioequivalence is established when there is an absence of a significant difference
in the rate and extent for absorption of the generic product and the reference listed drug. For some drugs, other means of demonstrating
bioequivalence may be required by the FDA, especially where rate or extent of absorption are difficult or impossible to measure. The
FDA will approve an ANDA application if it finds that the generic product does not raise new questions of safety and effectiveness as
compared to the reference listed drug. A product is not eligible for ANDA approval if the FDA determines that it is not bioequivalent
to the reference listed drug if it is intended for a different use or if it is not subject to, and requires, an approved Suitability
Petition.
Patent Exclusivity and Orange Book Listing
In seeking approval for a drug through an NDA,
including a 505(b)(2) NDA, applicants are required to list with the FDA certain patents whose claims cover the applicant’s product.
Upon approval of an NDA, each of the patents listed in the application for the drug is then published in the Orange Book. Any applicant
who files an ANDA seeking approval of a generic equivalent version of a drug listed in the Orange Book or a 505(b)(2) NDA referencing
a drug listed in the Orange Book must certify to the FDA (i) that there is no patent listed with the FDA as covering the relevant
branded product, (ii) that any patent listed as covering the branded product has expired, (iii) that the patent listed as covering
the branded product will expire prior to the marketing of the generic product, in which case the ANDA will not be finally approved by
the FDA until the expiration of such patent or (iv) that any patent listed as covering the branded drug is invalid or will not be
infringed by the manufacture, sale or use of the generic product for which the ANDA is submitted. A notice of the Paragraph IV certification
must be provided to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which
the ANDA or 505(b)(2) application refers. The applicant may also elect to submit a “section viii” statement certifying that
its proposed label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed
method-of-use patent.
If the reference NDA holder and patent owners
assert a patent challenge directed to one of the Orange Book listed patents within 45 days of the receipt of the Paragraph IV certification
notice, the FDA is prohibited from approving the application until the earlier of 30 months from the receipt of the Paragraph IV certification,
expiration of the patent, settlement of the lawsuit or a decision in the infringement case that is favorable to the applicant. The ANDA
or 505(b)(2) application also will not be approved until any applicable non-patent exclusivity listed in the Orange Book for the branded
reference drug has expired as described in further detail below.
Non-Patent Exclusivity
In addition to patent exclusivity, the holder
of the NDA for the listed drug may be entitled to a period of non-patent exclusivity, during which the FDA cannot approve an ANDA or
505(b)(2) application that relies on the listed drug.
For example, a drug that is considered new chemical
entity (NCE) at the time of approval may be awarded a five-year period of marketing exclusivity, starting at the time of product approval.
An ANDA or 505(b)(2) application referencing that drug may not be approved until the five-year period expires. Also, an ANDA or 505(b)(2)
application referencing that drug may not filed with the FDA until the expiration of five years, unless the submission is accompanied
by a Paragraph IV certification, in which case the applicant may submit its application four years following the original product approval.
A drug, including one approved under Section 505(b)(2),
may obtain a three-year period of exclusivity for a particular condition of approval, or change to a marketed product, such as a new
formulation for a previously approved product, if one or more new clinical studies (other than bioavailability or bioequivalence studies)
was essential to the approval of the application and was conducted/sponsored by the applicant.
DEA Regulation
Our product candidates may be regulated as “controlled
substances” as defined in the Controlled Substances Act of 1970, as amended, which establishes registration, security, recordkeeping,
reporting, storage, distribution and other requirements administered by the U.S. Drug Enforcement Agency (the “DEA”). The
DEA is concerned with, among other things, the control of handlers of controlled substances and with the equipment and raw materials
used in their manufacture and packaging, in order to prevent loss and diversion into illicit channels of commerce.
The DEA regulates controlled substances as Schedule
I, II, III, IV or V substances. A pharmaceutical product may be listed as Schedule II, III, IV or V, with Schedule II substances considered
to present the highest risk of abuse and Schedule V substances the lowest relative risk of abuse among such substances. The manufacture,
shipment, storage, sale and use of Schedule II drugs are subject to a high degree of regulation. For example, Schedule II drug prescriptions
generally must be signed by a physician and may not be refilled without a new prescription. Substances in Schedule IV are considered
to have a lower potential for abuse relative to substances in Schedule II. A prescription for controlled substances in Schedule III and
IV may be issued by a practitioner through oral communication, in writing or by facsimile to the pharmacist and may be refilled if so,
authorized on the prescription or by call-in. In the future, our other potential products may also be listed by the DEA as controlled
substances.
Annual registration is required for any facility
that manufactures, distributes, dispenses, imports or exports any controlled substance. The registration is specific to the particular
location, activity and controlled substance schedule. For example, separate registrations are needed for import and manufacturing, and
each registration will specify which schedules of controlled substances are authorized.
The DEA typically inspects a facility to review
its security measures prior to issuing a registration. Security requirements vary by controlled substance schedule, with the most stringent
requirements applying to Schedule I and Schedule II substances. Required security measures include background checks on employees and
physical control of inventory through measures such as cages, surveillance cameras and inventory reconciliations. Records must be maintained
for the handling of all controlled substances and periodic reports must be made to the DEA, including, for example, distribution reports
for Schedule II controlled substances, Schedule III substances that are narcotics and other designated substances. Reports must also
be made for thefts or losses of any controlled substance and authorization must be obtained to destroy any controlled substance. In addition,
special authorization and notification requirements apply to imports and exports.
In addition, a DEA quota system controls and
limits the availability and production of controlled substances in Schedule II. Distributions of any Schedule II controlled substance
must also be accompanied by special order forms, with copies provided to the DEA. The DEA establishes annually an aggregate quota for
how much of a Schedule II substance may be produced in total in the United States based on the DEA’s estimate of the quantity
needed to meet legitimate scientific and medicinal needs. This limited aggregate amount of any particular Schedule II substance that
the DEA allows to be produced in the United States each year is allocated among individual companies, who must submit applications
annually to the DEA for individual production and procurement quotas. We and our contract manufacturers must receive an annual quota
from the DEA in order to produce or procure any Schedule II substance for use in manufacturing. The DEA may adjust aggregate production
quotas and individual production and procurement quotas from time to time during the year, although the DEA has substantial discretion
in whether or not to make such adjustments. Our and our contract manufacturers’ quota of an active ingredient may not be sufficient
to meet commercial demand or complete clinical trials. Any delay or refusal by the DEA in establishing our and our contract manufacturers’
quota for controlled substances could delay or stop our clinical trials or product launches, which could have a material adverse effect
on our business, financial position and results of operations.
To meet its responsibilities, the DEA conducts
periodic inspections of registered establishments that handle controlled substances. Failure to maintain compliance with applicable requirements,
particularly as manifested in loss or diversion, can result in enforcement action that could have a material adverse effect on our business,
results of operations and financial condition. The DEA may seek civil penalties, refuse to renew necessary registrations or initiate
proceedings to revoke those registrations. In certain circumstances, violations could result in criminal proceedings.
Individual states also regulate controlled substances,
and we and our contract manufacturers will be subject to state regulation on distribution of these products.
Pricing and Reimbursement
Successful commercialization of our products
depends, in part, on the availability of governmental and third-party payor reimbursement for the cost of our products. Government authorities
and third-party payors increasingly are challenging the price of medical products and services. On the government side, there is a heightened
focus, at both the federal and state levels, on decreasing costs and reimbursement rates for Medicaid, Medicare and other government
insurance programs. This has led to an increase in federal and state legislative initiatives related to drug prices, which could significantly
influence the purchase of pharmaceutical products, resulting in lower prices and changes in product demand. If enacted, these changes
could lead to reduced payments to pharmaceutical manufacturers. Many states have also created preferred drug lists and include drugs
on those lists only when the manufacturers agree to pay a supplemental rebate. If our current products or future drug candidates are
not included on these preferred drug lists, physicians may not be inclined to prescribe them to their Medicaid patients, thereby diminishing
the potential market for our products.
In addition, third-party payors have been imposing
additional requirements and restrictions on coverage and limiting reimbursement levels for pharmaceutical products. Third-party payors
may require manufacturers to provide them with predetermined discounts from list prices and limit coverage to specific pharmaceutical
products on an approved list, or formulary, which might not include all of the FDA-approved pharmaceutical products for particular indications.
Third-party payors may challenge the price and examine the medical necessity and cost-effectiveness of pharmaceutical products in addition
to their safety and efficacy. Manufacturers may need to conduct expensive pharmaco-economic studies in order to demonstrate the medical
necessity and cost-effectiveness of pharmaceutical products in addition to the costs required to obtain the FDA approvals. Adequate third-party
reimbursement may not be available to enable manufacturers to maintain price levels sufficient to realize an appropriate return on their
investment in drug development.
Healthcare Reform
In the United States, there have been a number
of federal and state proposals during the last several years regarding the pricing of pharmaceutical products, government control and
other changes to the healthcare system of the United States. It is uncertain what other legislative proposals may be adopted or
what actions federal, state, or private payors may take in response to any healthcare reform proposals or legislation. We cannot predict
the effect such reforms may have on our business, and no assurance can be given that any such reforms will not have a material adverse
effect.
By way of example, in March 2010, the ACA
was signed into law, which, among other things, includes changes to the coverage and payment for drug products under government health
care programs. The law includes measures that (i) significantly increase Medicaid rebates through both the expansion of the program
and significant increases in rebates, (ii) substantially expand the Public Health System (340B) program to allow other entities
to purchase prescription drugs at substantial discounts, (iii) extend the Medicaid rebate rate to a significant portion of Managed
Medicaid enrollees, (iv) assess a rebate on Medicaid Part D spending in the coverage gap for branded and authorized generic prescription
drugs, and (v) levy a significant excise tax on the industry to fund the healthcare reform.
Additionally, there has been heightened governmental
scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. On
September 9, 2021, the Biden Administration published a wide-ranging list of policy proposals, most of which would need to be carried
out by Congress, to reduce drug prices and drug payment. The United States Department of Health and Human Services (“HHS”)
plan includes, among other reform measures, proposals to lower prescription drug prices, including by allowing Medicare to negotiate
prices and disincentivizing price increases, and to support market changes that strengthen supply chains, promote biosimilars and generic
drugs, and increase price transparency. These initiatives recently culminated in the enactment of the Inflation Reduction Act (the
“IRA”) in August 2022, which will, among other things, allow the HHS to negotiate the selling price of certain drugs and
biologics that the Centers for Medicare & Medicaid Services (“CMS”) reimburses under Medicare Part B and Part D, although
only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for biologics) can be selected by CMS
for negotiation, with the negotiated price taking effect two years after the selection year. The negotiated prices, which will first
become effective in 2026, will be capped at a statutory ceiling price beginning in October 2023, penalize drug manufacturers that increase
prices of Medicare Part B and Part D drugs at a rate greater than the rate of inflation. The IRA permits the Secretary of HHS to implement
many of these provisions through guidance, as opposed to regulation, for the initial years. Manufacturers that fail to comply with the
IRA may be subject to various penalties, including civil monetary penalties. The IRA also extends enhanced subsidies for individuals
purchasing health insurance coverage in ACA marketplaces through plan year 2025. These provisions will take effect progressively starting
in 2023, although they may be subject to legal challenges.
Healthcare Regulations
Pharmaceutical companies are subject to various
federal and state laws that are intended to combat health care fraud and abuse and that govern certain of our business practices, especially
our interactions with third-party payors, healthcare providers, patients, customers and potential customers through sales and marketing
or research and development activities. These include anti-kickback laws, false claims laws, sunshine laws, privacy laws and FDA regulation
of advertising and promotion of pharmaceutical products.
Anti-kickback laws, including the federal Anti-Kickback
Statute, make it a criminal offense knowingly and willfully to offer, pay, solicit, or receive any remuneration to induce or reward referral
of an individual for, or the purchase, order or recommendation of, any good or service reimbursable by, a federal health care program
(including our products). The 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 several statutory exceptions and
regulatory safe harbors protecting certain common activities from prosecution, the exceptions and safe harbors are drawn narrowly, and
practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do
not qualify for an exception or safe harbor. In addition, a person or entity does not need to have actual knowledge of the statute or
specific intent to violate it to have committed a violation. Moreover, the government may assert that a claim including items or services
resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims
Act. The penalties for violating the federal Anti-Kickback Statute include administrative civil money penalties, imprisonment for up
to five years, fines of up to $25,000 per violation and possible exclusion from federal healthcare programs such as Medicare and Medicaid.
The federal civil and criminal false claims laws,
including the civil False Claims Act, prohibit knowingly presenting, or causing to be presented, claims for payment to the federal government
(including Medicare and Medicaid) that are false or fraudulent (and, under the Federal False Claims Act, a claim is deemed false or fraudulent
if it is made pursuant to an illegal kickback). Manufacturers can be held liable under these laws if they are deemed to “cause”
the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting
a product off-label. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual
in the name of the government. Violations of the False Claims Act can result in significant monetary penalties, including fines ranging
from $11,181 to $22,363 for each false claim, and treble damages. The federal government is using the False Claims Act, and the accompanying
threat of significant liability, in its investigation and prosecution of pharmaceutical companies throughout the country, for example,
in connection with the promotion of products for unapproved uses and other improper sales and marketing practices. The government has
obtained multi-million and multi-billion dollar settlements under the False Claims Act in addition to individual criminal convictions
under applicable criminal statutes. In addition, companies have been forced to implement extensive corrective action plans and have often
become subject to consent decrees or corporate integrity agreements, severely restricting the manner in which they conduct their business.
Given the significant size of actual and potential settlements, it is expected that the government will continue to devote substantial
resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws.
The Federal Civil Monetary Penalties Law prohibits,
among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should
know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.
Noncompliance can result in civil money penalties of up to $15,270 for each wrongful act, assessment of three times the amount claimed
for each item or service and exclusion from the federal healthcare programs.
Federal criminal statutes prohibit, among other
actions, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including private
third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal
investigation of a healthcare offense, 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. Like the federal Anti-Kickback Statute, the ACA amended the intent standard for certain healthcare fraud statutes under HIPAA
such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have
committed a violation.
Analogous state and foreign laws and regulations,
including state anti-kickback and false claims laws, may apply to products and services reimbursed by non-governmental third-party payors,
including commercial payors. Additionally, there are 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 or that otherwise
restrict payments that may be made to healthcare providers as well as state and foreign laws that require drug manufacturers to report
marketing expenditures or pricing information.
Sunshine laws, including the Federal Open Payments
law enacted as part of the ACA, require pharmaceutical manufacturers to disclose payments and other transfers of value to physicians
and certain other health care providers or professionals, and in the case of some state sunshine laws, restrict or prohibit certain such
payments. Pharmaceutical manufacturers are required to submit reports to the government by the 90th day of each calendar year.
Failure to submit the required information may result in civil monetary penalties of up to an aggregate of $165,786 per year (or up to
an aggregate of $1.105 million per year for “knowing failures”) for all payments, transfers of value or ownership or investment
interests not reported in an annual submission and may result in liability under other federal laws or regulations. Certain states and
foreign governments require the tracking and reporting of gifts, compensation and other remuneration to physicians.
Privacy laws, such as the privacy regulations
implemented under HIPAA, restrict covered entities from using or disclosing protected health information. Covered entities commonly include
physicians, hospitals and health insurers from which we may seek to acquire data to aid in our research, development, sales and marketing
activities. Although pharmaceutical manufacturers are not covered entities under HIPAA, our ability to acquire or use protected health
information from covered entities may be affected by privacy laws. Specifically, HIPAA, as amended by HITECH, and their respective implementing
regulations, including the final omnibus rule published on January 25, 2013, imposes specified requirements relating to the privacy,
security and transmission of individually identifiable health information.
Among other things, HITECH makes HIPAA’s
privacy and security standards directly applicable to “business associates,” defined as independent contractors or agents
of covered entities that create, receive, maintain or transmit protected 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 the federal HIPAA laws 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 differ from each
other in significant ways, thus complicating compliance efforts.
The FDA regulates the sale and marketing of prescription
drug products and, among other things, prohibits pharmaceutical manufacturers from making false or misleading statements and from promoting
products for unapproved uses. There has been an increase in government enforcement efforts at both the federal and state level. Numerous
cases have been brought against pharmaceutical manufacturers under the Federal False Claims Act, alleging, among other things, that certain
sales or marketing-related practices violate the Anti-Kickback Statute or the FDA’s regulations, and many of these cases have resulted
in settlement agreements under which the companies were required to change certain practices, pay substantial fines and operate under
the supervision of a federally appointed monitor for a period of years. Due to the breadth of these laws and their implementing regulations
and the absence of guidance in some cases, it is possible that our practices might be challenged by government authorities. Violations
of fraud and abuse laws may be punishable by civil and criminal sanctions including fines, civil monetary penalties, as well as the possibility
of exclusion of our products from payment by federal health care programs.
Government Price Reporting
Government regulations regarding reporting and
payment obligations are complex, and we are continually evaluating the methods we use to calculate and report the amounts owed with respect
to Medicaid and other government pricing programs. Our calculations are subject to review and challenge by various government agencies
and authorities, and it is possible that any such review could result either in material changes to the method used for calculating the
amounts owed to such agency or the amounts themselves. Because the process for making these calculations, and our judgments supporting
these calculations, involve subjective decisions, these calculations are subject to audit. In the event that a government authority challenges
or finds ambiguity with regard to our report of payments, such authority may impose civil and criminal sanctions, which could have a
material adverse effect on our business. From time to time we conduct routine reviews of our government pricing calculations. These reviews
may have an impact on government price reporting and rebate calculations used to comply with various government regulations regarding
reporting and payment obligations.
Many governments and third-party payors reimburse
the purchase of certain prescription drugs based on a drug’s AWP. In the past several years, state and federal government agencies
have conducted ongoing investigations of manufacturers’ reporting practices with respect to AWP, which they have suggested have
led to excessive payments by state and federal government agencies for prescription drugs. We and numerous other pharmaceutical companies
have been named as defendants in various state and federal court actions alleging improper or fraudulent practices related to the reporting
of AWP.
Drug Pedigree Laws
State and federal governments have proposed or
passed various drug pedigree laws which can require the tracking of all transactions involving prescription drugs from the manufacturer
to the pharmacy (or other dispensing) level. Companies are required to maintain records documenting the chain of custody of prescription
drug products beginning with the purchase of such products from the manufacturer. Compliance with these pedigree laws requires implementation
of extensive tracking systems as well as heightened documentation and coordination with customers and manufacturers. While we fully intend
to comply with these laws, there is uncertainty about future changes in legislation and government enforcement of these laws. Failure
to comply could result in fines or penalties, as well as loss of business that could have a material adverse effect on our financial
results.
Federal Regulation of Patent Litigation
Settlements and Authorized Generic Arrangements
As part of the Medicare Prescription Drug Improvement
and Modernization Act of 2003, companies are required to file with the U.S. Federal Trade Commission (“FTC”) and the U.S.
Department of Justice (the “DOJ”) certain types of agreements entered into between brand and generic pharmaceutical companies
related to the settlement of patent litigation or manufacture, marketing and sale of generic versions of branded drugs. This requirement
could affect the manner in which generic drug manufacturers resolve intellectual property litigation and other disputes with brand pharmaceutical
companies and could result generally in an increase in private-party litigation against pharmaceutical companies or additional investigations
or proceedings by the FTC or other governmental authorities.
Other
The U.S. federal government, various states and
localities have laws regulating the manufacture and distribution of pharmaceuticals, as well as regulations dealing with the substitution
of generic drugs for branded drugs. Our operations are also subject to regulation, licensing requirements and inspection by the states
and localities in which our operations are located or in which we conduct business.
Certain of our activities are also subject to
FTC enforcement actions. The FTC also enforces a variety of antitrust and consumer protection laws designed to ensure that the nation’s
markets function competitively, are vigorous, efficient and free of undue restrictions. Federal, state, local and foreign laws of general
applicability, such as laws regulating working conditions, also govern us.
In addition, we are subject to numerous and increasingly
stringent federal, state and local environmental laws and regulations concerning, among other things, the generation, handling, storage,
transportation, treatment and disposal of toxic and hazardous substances, the discharge of pollutants into the air and water and the
cleanup of contamination. We are required to maintain and comply with environmental permits and controls for some of our operations,
and these permits are subject to modification, renewal and revocation by the issuing authorities. Our environmental capital expenditures
and costs for environmental compliance may increase in the future as a result of changes in environmental laws and regulations or increased
manufacturing activities at any of our facilities. We could incur significant costs or liabilities as a result of any failure to comply
with environmental laws, including fines, penalties, third-party claims and the costs of undertaking a clean-up at a current or former
site or at a site to which our wastes were transported. In addition, we have grown in part by acquisition, and our diligence may not
have identified environmental impacts from historical operations at sites we have acquired in the past or may acquire in the future.
Human Capital Resources
As of March 15, 2024, we have a total of 7 full
time employees. We have no collective bargaining agreements with our employees, and none are represented by labor unions. We consider
our current relations with our employees to be good.
We believe that our future success will depend,
in part, on our continued ability to attract, hire and retain qualified personnel. In particular, we depend on the skills, experience
and performance of our senior management and research personnel. We compete for qualified personnel with other medical pharmaceutical,
and healthcare companies, as well as universities and non-profit research institutions.
We provide competitive compensation and benefits
programs to help meet the needs of our employees. In addition to salaries, these programs (which vary by country/region and employment
classification) include incentive compensation plans, healthcare and insurance benefits, retirement investments, paid time off, and family
leave, among others. We also use targeted equity-based grants with vesting conditions to facilitate retention of personnel, particularly
for our key employees.
The success of our business is fundamentally
connected to the well-being of our people. Accordingly, we are committed to the health and safety of our employees. In response to the
COVID-19 pandemic, we implemented significant changes that we determined were in the best interest of our employees, as well as the communities
in which we operate, and which comply with government regulations.
Facilities
Our principal address is 1055 Westlakes Drive,
Suite 300, Berwyn, Pennsylvania 19312. We believe our facilities are adequate to meet our current needs, although we may seek to negotiate
new leases or evaluate additional or alternate space for our operations. We believe appropriate alternative space would be readily available
on commercially reasonable terms.
Our telephone number is (610) 727-4597 and our
website address is www.virpaxpharma.com. The information on our website is not incorporated by reference into this Annual Report on Form
10-K.
Item 1A. RISK FACTORS
Risks Related to Our Financial Position and
Need for Additional Capital
We are a preclinical stage biopharmaceutical
company with a limited operating history.
We were established
and began operations in 2017. Our operations to date have been limited to financing and staffing our company, licensing product candidates,
conducting preclinical studies of Epoladerm for chronic osteoarthritis of the knee, Probudur for postoperative pain management, Envelta
to control severe pain, including post cancer pain, AnQlar as an anti-viral barrier to potentially prevent or reduce the risk or the
intensity of viral infections in humans, including, but not limited to, influenza and SARS-CoV-2 (COVID 19), and NobrXiol to potentially
treat epileptic seizures associated with, Lennox-Gastaut syndrome and Dravet syndrome in pediatric patients two years of age and older.
We have not yet demonstrated the ability to successfully complete a large-scale, pivotal clinical trial, obtain marketing approval, manufacture
a commercial scale product, arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for
successful product commercialization. Consequently, predictions about our future success or viability may not be as accurate as they
could be if we had a history of successfully developing and commercializing pharmaceutical products.
Accordingly, you should consider our prospects
in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the early stages of development,
especially preclinical stage pharmaceutical companies such as ours. Potential investors should carefully consider the risks and uncertainties
that a company with a limited operating history will face. In particular, potential investors should consider that we cannot assure you
that we will be able to, among other things:
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successfully
implement or execute our current business plan, and we cannot assure you that our business plan is sound; |
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successfully manufacture
our clinical product candidates and establish commercial supply; |
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● |
successfully complete the
clinical trials necessary to obtain regulatory approval for the marketing of our product candidates; |
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secure market exclusivity
and/or adequate intellectual property protection for our product candidates; |
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attract and retain an experienced
management and advisory team; |
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● |
secure acceptance of our
product candidates in the medical community and with third-party payors and consumers; |
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raise sufficient funds
in the capital markets or otherwise to effectuate our business plan; and |
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utilize the funds that
we do have and/or raise in the future to efficiently execute our business strategy. |
If we cannot successfully execute any one of
the foregoing, our business may fail and your investment will be adversely affected.
We have incurred losses since inception
and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve
or sustain profitability.
We are a preclinical stage biopharmaceutical company
with a limited operating history and have incurred losses since our formation. We incurred net losses of approximately $15.2 million and
$21.7 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, we had an accumulated deficit of
approximately $59.5 million. We have not commercialized any product candidates and have never generated revenue from the commercialization
of any product. To date, we have devoted most of our financial resources to research and development, including our preclinical work,
general and administrative expenses which have primarily consisted of legal defense costs, legal settlement, and general corporate purposes.
We expect to incur significant additional operating
losses for the next several years, at least, as we advance Epoladerm, Probudur, Envelta, AnQlar and NobrXiol through preclinical development,
complete clinical trials, seek regulatory approval and commercialize Epoladerm, Probudur, Envelta, AnQlar and NobrXiol (collectively,
“Product Candidates”), if approved. The costs of advancing product candidates into each clinical phase tend to increase substantially
over the duration of the clinical development process. Therefore, the total costs to advance any of our product candidates to marketing
approval in even a single jurisdiction will be substantial. Because of the numerous risks and uncertainties associated with pharmaceutical
product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to
begin generating revenue from the commercialization of any products or achieve or maintain profitability. Our costs and expenses will
also increase substantially if and as we:
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Fund the remaining portion $2.5 million pursuant to the Settlement
Agreement, make related indemnification and/or contribution payments, which payment, if any, may be material, or estimated separation
payments we agree to make to our former Chief Executive Officer, which may be material (See Item 3-Legal Proceedings); |
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are required by the FDA,
to complete Phase 2 trials to support an NDA for our Product Candidates; |
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are required by the FDA
to complete Phase 3 trials to support NDAs for our Product Candidates; |
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establish a sales, marketing
and distribution infrastructure to commercialize our drugs, if approved, and for any other product candidates for which we may obtain
marketing approval; |
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maintain, expand and protect
our intellectual property portfolio; |
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hire additional clinical,
scientific and commercial personnel; |
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add operational, financial
and management information systems and personnel, including personnel to support our product development and planned future commercialization
efforts, as well as to support our transition to a public reporting company; and |
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acquire or in-license or
invent other product candidates or technologies. |
Furthermore, our ability to successfully develop,
commercialize and license any product candidates and generate product revenue is subject to substantial additional risks and uncertainties,
as described under “Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval” and “Risks
Related to Commercialization.” As a result, we expect to continue to incur net losses and negative cash flows for the foreseeable
future. These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity
and working capital. The amount of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability
to generate revenues. If we are unable to develop and commercialize one or more product candidates, either alone or through collaborations,
or if revenues from any product that receives marketing approval are insufficient, we will not achieve profitability. Even if we do achieve
profitability, we may not be able to sustain profitability or meet outside expectations for our profitability. If we are unable to achieve
or sustain profitability or to meet outside expectations for our profitability, the value of our common stock will be materially and
adversely affected.
The report of
our independent registered public accounting firm for the fiscal years ended December 31, 2023 and 2022 contains an explanatory paragraph
regarding substantial doubt about our ability to continue as a going concern.
The report of our independent
registered public accounting firm on our financial statements as of and for the years ended December 31, 2023 and December 31, 2022 includes
an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern. Due to our continuing
losses and the anticipated significant decrease in our cash position from the payments to be made to the Plaintiffs pursuant to the Settlement
Agreement, there exists substantial doubt about our ability to continue as a going concern. Pursuant to the Settlement Agreement, we have
paid the Plaintiffs $3.5 million on March 18, 2024, and agreed to make an additional $2.5 million payment on or before July 1, 2024. The
financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses
that may be necessary if we were unable to continue as a going concern.
We will require additional financings to fund
our operations, including completing clinical development of and to commercially develop all of our product candidates and/or to fund
litigation costs and expenses, including the required payment of the $2.5 million on or before July 1, 2024, related indemnification and/or
contribution payments, if any, and which such payments may be material, as well as other potential estimated separation payments to our
former Chief Executive Officer, which also may be material. There is no assurance that such financing will be available when needed or
on acceptable terms. We also may be forced to curtail spending in research and development activities in order to conserve cash.
We will require additional capital to fund
our operations, and if we fail to obtain necessary financing, we will not be able to complete the development and commercialization of
our drugs.
Our operations have consumed
substantial amounts of cash since inception. In addition, due to the $3.5 million payment that has been made, and the $2.5 million payment
that will be required to be made on or before July 1, 2024, to the Plaintiffs pursuant to the Settlement Agreement our cash position has
been and will be significantly decreased. The payment of the royalties to the Plaintiffs pursuant
to the terms of the Settlement Agreement, will significantly impact our future revenue and may make it more difficult to engage in collaborations,
licenses or the acquisition of certain product candidates, and may result in us ceasing to develop certain product candidates or
all of our product candidates if we determine that it will not be financially profitable to do so.
In addition, litigation related indemnification and/or contribution payments, if any, and which
may be material, and any cash estimated separation payments, which may be material, that
we make to our former Chief Executive Officer will further reduce our cash position. We expect to continue to spend substantial
amounts to advance the clinical development of and launch and commercialize our product candidates if we receive regulatory approval.
In addition, the damages that we are required to pay in connection with our litigation have and will impact the amount of cash available
for clinical development of our product candidates. Our current cash position is not sufficient to enable us to fund our operations, including
making the second payment under the Settlement Agreement. If we are unable to raise additional capital in the next few months, of which
there can be no certainty, we may be forced to liquidate assets or initiate bankruptcy proceedings.
We will require additional
capital for the further development and potential commercialization of our Product Candidates and may also need to raise additional funds
sooner to pursue a more accelerated development of our Product Candidates. If we are unable to raise capital when needed or on attractive
terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts.
In addition, our strategy for AnQlar and Epoladerm is to license out or partner these assets as we continue to focus our efforts on our
prescription drug pipeline. If we are unsuccessful in our partnering activities and/or financing activities, we may be unable to develop
AnQlar and Epoladerm.
At December 31, 2023, we had cash of approximately
$9.1 million. On March 18, 2024, we paid $3.5 million to the Plaintiffs and we have agreed to pay the Plaintiffs an additional $2.5 million
on or before July 1, 2024. In addition, litigation related indemnification and/or contribution
payments, if any, and which may be material, and any cash estimated separation payments
that we make to our former Chief Executive Officer, which may be material, will further reduce our cash position. See Note 5 to
the Notes to Financial Statements included in this Annual Report on Form 10-K for additional information regarding these payments. We
have incurred losses since inception, including a loss of $15.2 million for the year ended December 31, 2023. Our future funding requirements,
both near and long-term, will depend on many factors, including, but not limited to the:
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costs associated with litigation, adverse remedy judgments and/or settlements; |
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initiation, progress, timing,
costs and results of preclinical studies and clinical trials, including patient enrollment in such trials, for our Product Candidates
or any other future product candidates; |
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clinical development plans
we establish for our Product Candidates and any other future product candidates; |
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obligation to make royalty
and non-royalty sublicense receipt payments to third-party licensors, if any, under our licensing agreements; |
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number and characteristics
of product candidates that we discover or in-license and develop; |
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outcome, timing and cost
of regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable
foreign regulatory authorities to require that we perform more studies than those that we currently expect; |
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costs of filing, prosecuting,
defending and enforcing any patent claims and maintaining and enforcing other intellectual property rights; |
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effects of competing technological
and market developments; |
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costs and timing of the
implementation of commercial-scale manufacturing activities; |
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costs and timing of establishing
sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval; and |
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cost associated with being
a public company. |
If we are unable to expand our operations or otherwise
capitalize on our business opportunities due to a lack of capital, our ability to become profitable or survive will be compromised.
Our business, financial condition and results
of operations could be adversely affected by indemnification and other claims related to the damages awarded in our recently settled
litigation with Sorrento Therapeutics, Inc. and Scilex Pharmaceuticals, Inc.
Per the Settlement Agreement, the Plaintiff’s
have released all claims against us. The Plaintiffs, however, can still pursue claims against Mr. Mack. Our Amended and Restated
Bylaws dated November 18, 2020 (“Bylaws”) require us to “indemnify any person who was or is a party or is threatened
to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative
(other than an action by or in the right of the Corporation) by reason of the fact that such person is or was a director or officer of
the Corporation, or, while a director or officer of the Corporation….” Such indemnification, however, is limited to
circumstances where the covered person “acted in good faith and in a manner such person reasonably believed to be in or not opposed
to the best interests of the Corporation….” Mr. Mack may attempt to claim he is entitled to indemnification, should
the Chancery Court find him liable for damages in the Action. Given the findings in the Memorandum Opinion issued in the Action,
we believe we have a strong position that Mr. Mack would not be entitled to indemnification. There is a risk, however, that a court could
find he is entitled to such indemnification. Additionally, per Section 7.6 of the Bylaws, we have been advancing Mr. Mack’s
attorneys’ fees and costs for the Action. It is likely Mr. Mack will contend he is still entitled to advancement of any fees
and/or costs for the Action going forward and may seek judicial intervention. However, as per the Bylaws, Mr. Mack is only entitled to
advancement of expenses for indemnifiable actions. As noted above, given the Memorandum Opinion in the Action, we believe that we have
a strong position that Mr. Mack is not entitled to indemnification, and therefore, not entitled to advancement of expenses. However, there
is a risk that a court could find that Mr. Mack is entitled to such advancement. Further, Mr. Mack may attempt to seek damages from
us based on the Chancery Court’s final judgment on damages under the theory of joint and several liability and seek contribution
from us for any monetary judgment.
The Chancery Court is aware that Plaintiffs have
settled with us and that the Settlement Agreement fully releases us from any claims or damages the Plaintiffs have against us related
to the Action. Given the Settlement Agreement does not release Mr. Mack from liability related to the Action, the Chancery Court has requested
supplemental briefing as to whether the Chancery Court can dismiss us from the lawsuit, as well as any claims Mr. Mack has against us
arising from the Action. While we believe that any damages assessed may be awarded against Mr. Mack alone, Plaintiffs cannot seek additional
damages from Virpax. However, there is a risk that Mr. Mack will still seek contribution from us for any damages claim arising from the
Action. And, there is a risk that the Chancery Court will rule in Mr. Mack’s favor.
No further reimbursements are permitted from our insurance policy
with respect to the litigation. Accordingly, if Mr. Mack was successful in seeking indemnification from us, we would have to pay such
amounts in cash which would further reduce our cash position.
Raising additional capital may cause dilution
to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
Until such time, if ever, as we can generate
substantial revenue, we may finance our cash needs through a combination of equity offerings, debt financings, marketing and distribution
arrangements and other collaborations, strategic alliances and licensing arrangements or other sources. We do not currently have any
committed external source of funds. In addition, we may seek additional capital due to favorable market conditions or strategic considerations,
even if we believe that we have sufficient funds for our current or future operating plans.
To the extent that we raise additional capital
through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities
may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity
financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such
as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations,
strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable
rights to our technologies, intellectual property, future revenue streams or product candidates or grant licenses on terms that may not
be favorable to us. If we are unable to raise additional funds through equity or debt financing when needed, we may be required to delay,
limit, reduce or terminate product candidate development or future commercialization efforts.
In addition, our strategy
for AnQlar and Epoladerm is to license out or partner this asset as we continue to focus our efforts on our prescription drug pipeline,
which may result in shared revenue.
Our ability to use our net operating loss
carryforwards to offset future taxable income may be subject to certain limitations.
Our net operating loss carryforwards (“NOLs”),
and certain other tax attributes could expire unused and be unavailable to offset future income tax liabilities because of their limited
duration or because of restrictions under U.S. tax law. As of December 31, 2023, we had NOLs of approximately $35.2 million for federal
and $37.1 million for state income tax purposes. Our federal NOL of $35.2 million includes $326,000 which expires in 2037, and the remaining
NOL has an indefinite carryover period subject to limitation, and our state NOL’s of $37.1 million expire from 2037 through
2043. Additionally, we have $654,000 of R&D credits which have a 20-year carryforward period, which will expire from 2038 to 2043.
Under TCJA (defined below), federal NOLs generated
in tax years ending after December 31, 2017 may be carried forward indefinitely. Under the CARES Act, NOL carryforwards arising in tax
years beginning after December 31, 2017 and before January 1, 2021 may be carried back to each of the five tax years preceding the tax
year of such loss. Due to our cumulative losses through December 31, 2023, we do not anticipate that such provision of the CARES Act
will be relevant to us. The deductibility of federal NOLs, particularly for tax years beginning after December 31, 2022, may be limited.
It is uncertain if and to what extent various states will conform to TCJA or the CARES Act.
In addition, our NOLs are subject to review and
possible adjustment by the IRS, and state tax authorities. In general, under Sections 382 and 383 of the Code, a corporation that
undergoes an “ownership change” is subject to limitations on its ability to use its pre-change NOLs and research & development
credit to offset future taxable income. Due to previous ownership changes, or if we undergo an ownership change, our ability to use our
NOLs and research & development credit could be limited by Section 382 of the Code. Future changes in our stock ownership, inclusive
of a public offering and some of which are outside of our control, could result in an ownership change under Sections 382 and 383
of the Code. Furthermore, our ability to use NOLs and research & development credit of companies that we may acquire in the future
may be subject to limitations. For these reasons, we may not be able to use a material portion of the NOLs and research & development
credit, even if we attain profitability.
We examined the application of Section 382 and
Section 383 with respect to ownership changes that took place during 2021, as well as the limitation on the application of net operating
loss carry forwards. We determined that a more than 50% ownership change occurred on September 16, 2021. We also determined that the
recent change in ownership limits our usage of net operating loss, other carry forwards and tax credits as of the change in ownership
date to an annual amount of $4.1 million. Our net carryforwards and tax credits may be further limited in the future if additional ownership
changes occur.
Our ability to further develop our product
candidates may be adversely affected by the terms of the Settlement Agreement.
The cash payments as well as the royalty payments
that we have agreed to pay to the Plaintiffs pursuant to the Settlement Agreement as well as any payments we may be required to make to
our former Chief Executive Officer, may result in us ceasing to develop certain product candidates or all of our product candidates if
we determine that it will not be financially profitable to do so. The payment of these royalties
will significantly impact our future revenue and may make it more difficult to engage in collaborations, licenses or the acquisition of
certain product candidates.
The Company and our officers and directors
may be subject to various types of litigation, and our insurance may not cover or be sufficient to cover damages related to
those claims.
From time-to-time we may be involved in lawsuits
or other claims arising in the ordinary course of business, including those related to product liability, consumer protection, employment,
intellectual property, tort, privacy and data protection, and other matters. Although we maintain insurance in accordance with customary
practice of companies of similar size and stage of development, our insurance may only cover us against some, and not all, of these potential
claims. We may incur losses relating to claims filed against us or our directors and officers, including costs associated with defending
against such claims, and there is risk that any such claims or liabilities will exceed our insurance coverage, or affect our
ability to retain adequate liability insurance in the future. We may elect not to obtain insurance if we believe
that the cost of available insurance is excessive relative to the risks presented. The levels of insurance we maintain
may not be adequate to fully cover any and all losses or liabilities. Further, we may not be able to maintain insurance at
commercially acceptable premium levels or at all. If any significant judgment, claim (or a series of claims), a settlement or other event
is not fully insured or indemnified against, it could have a material adverse impact on our business, financial condition and results
of operations. There can be no assurance as to the actual amount of these liabilities or the timing thereof. We cannot be certain that
the outcome of current or future litigation will not have a material adverse impact on our business and results of operations.
Risks Related to Development, Clinical Testing,
Manufacturing and Regulatory Approval
Clinical trials are expensive, time-consuming
and difficult to design and implement, and involve an uncertain outcome.
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 trial process. Because
the results of preclinical studies and early clinical trials are not necessarily predictive of future results, our Product Candidates
may not have favorable results in later preclinical and clinical studies or receive regulatory approval. We may experience delays in
initiating and completing any clinical trials that we intend to conduct, and we do not know whether planned clinical trials will begin
on time, need to be redesigned, enroll patients on time or be completed on schedule, or at all. Clinical trials can be delayed for a
variety of reasons, including delays related to:
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the FDA or comparable foreign
regulatory authorities disagreeing as to the design or implementation of our clinical studies; |
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obtaining regulatory approval
to commence a trial; |
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reaching an agreement on
acceptable terms with prospective CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and
may vary significantly among different CROs and trial sites; |
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obtaining Institutional
Review Board (“IRB”), approval at each site, or Independent Ethics Committee (“IEC”), approval at sites outside
the United States; |
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recruiting suitable patients
to participate in a trial in a timely manner and in sufficient numbers; |
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having patients complete
a trial or return for post-treatment follow-up; |
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imposition of a clinical
hold by regulatory authorities, including as a result of unforeseen safety issues or side effects or failure of trial sites to adhere
to regulatory requirements or follow trial protocols; |
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clinical sites deviating
from trial protocol or dropping out of a trial; |
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addressing patient safety
concerns that arise during the course of a trial; |
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adding a sufficient number
of clinical trial sites; or |
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manufacturing sufficient
quantities of product candidate for use in clinical trials. |
We could also encounter delays if a clinical
trial is suspended or terminated by us, the IRBs or IECs of the institutions in which such trials are being conducted, the Data Safety
Monitoring Board (“DSMB”) for such trial or the FDA or other regulatory authorities. Such authorities may impose such a suspension
or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements
or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting
in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a
drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. Furthermore,
we rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and, while we have agreements
governing their committed activities, we have limited influence over their actual performance, as described in “Risks Related to
Our Dependence on Third Parties”.
Disruptions in the global economy and supply
chains may have a material adverse effect on our business, financial condition and results of operations.
The disruptions to the global economy which began
in 2020 have impeded global supply chains, resulting in longer lead times and also increased critical component costs and freight expenses.
We have encountered disruptions in our supply of various materials. We have taken and may have to take steps to minimize the impact of
these disruptions in lead times and increased costs by working closely with our suppliers and other third parties on whom we rely for
the conduct of our business. Despite the actions we have undertaken or may have to undertake to minimize the impacts from disruptions
to the global economy, there can be no assurances that unforeseen future events in the global supply chain will not have a material adverse
effect on our business, financial condition and results of operations.
We rely on, and expect to continue to rely on, third-party providers
for the supply of materials and for research. The circumstances relating to the the Russian invasion of Ukraine, the war in the Middle
East, as well as other global conditions, have caused significant shortages in the supply chain. We are continuously evaluating alternative
and secondary source suppliers in order to ensure that we are able to source sufficient materials. In the event we are unable source sufficient
materials from our current suppliers, or to develop relationships with additional suppliers, our business operations could suffer. To
the extent our current suppliers, or any suppliers that we engage in the future, are unable to meet our requirements in a timely and cost-effective
manner, including as a result of circumstances relating to the the Russian invasion of Ukraine, the war in the Middle East, we may not
be able to obtain an adequate supply of materials. Any shortage of materials caused by any disruption or unavailability of supply could
harm our business operations, delay the development of our product candidates, or increase our costs and decrease our revenue. Any such
impacts or delays could adversely affect our financial condition and our business may be adversely affected. Our efforts to mitigate supply
chain weaknesses may not be successful or may have unfavorable effects.
Furthermore, inflation can adversely affect us
by increasing the costs of clinical trials, the research and development of our product candidates, as well as administration and other
costs of doing business. We may experience increases in the prices of labor and other costs of doing business. In an inflationary environment,
cost increases may outpace our expectations, causing us to use our cash and other liquid assets faster than forecasted. If this happens,
we may need to raise additional capital to fund our operations, which may not be available in sufficient amounts or on reasonable terms,
if at all, sooner than expected.
Adverse global conditions, including economic
uncertainty, may negatively impact our financial results.
Global conditions, dislocations in the financial
markets, any negative financial impacts affecting United States as a result of tax reform or changes to existing trade agreements or
tax conventions, may adversely impact our business.
In addition, the global macroeconomic environment
could be negatively affected by, among other things, resurgence of COVID-19 or other pandemics or epidemics, instability in global economic
markets, increased U.S. trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain
weaknesses, instability in the geopolitical environment as a result of the Russian invasion of Ukraine, the war in the Middle East, other
political tensions, and foreign governmental debt concerns. Such challenges have caused, and may continue to cause, uncertainty and instability
in local economies and in global financial markets.
Our development activities for Probudur
are conducted in Israel. The war in the Middle East, may affect our operations.
Lipocure, the company performing all of the development
work for Probudur, is located in Israel. If Lipocure were to be unable to continue to perform development work for us or were to be delayed
in its performance of development work due to the war in the Middle East, our development timelines will be adversely impacted and we
may not be able to develop Probudur within the timeline anticipated, if at all. There can be no assurance that we will be able to find
alternative developers at favorable prices.
The regulatory approval processes of the
FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain
regulatory approval for our Product Candidates or any other product candidates, our business will be substantially harmed.
The time required to obtain approval by the FDA
and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and
depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations
or the type and amount of clinical data necessary to gain regulatory approval may change during the course of a product candidate’s
clinical development and may vary among jurisdictions. We have not obtained regulatory approval for any product candidate and it is possible
that we will never obtain regulatory approval for our Product Candidates or any other product candidate. We are not permitted to market
any of our product candidates in the United States until we receive regulatory approval of an NDA from the FDA. Our product candidates
could fail to receive regulatory approval for many reasons, including the following:
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we may be unable to demonstrate
to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its
proposed indication; |
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serious and unexpected
drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product
candidates, or other products containing the active ingredient in our product candidates; |
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negative or ambiguous results
from our clinical trials or results that may not meet the level of statistical significance required by the FDA or comparable foreign
regulatory authorities for approval; |
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we may be unable to demonstrate
that a product candidate’s clinical and other benefits outweigh its safety risks; |
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the FDA or comparable foreign
regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
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the data collected from
clinical trials of our product candidates may not be acceptable or sufficient to support the submission of an NDA or other submission
or to obtain regulatory approval in the United States or elsewhere, and we may be required to conduct additional clinical trials; |
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the FDA or comparable foreign
authorities may disagree regarding the formulation, labeling and/or the specifications of our product candidates; |
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the FDA or comparable foreign
regulatory authorities may fail to approve or find deficiencies with the manufacturing processes 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 significantly change in a manner rendering our clinical data
insufficient for approval. |
Prior to obtaining approval to commercialize
a product candidate in the United States or abroad, we must demonstrate with substantial evidence from well-controlled clinical
trials, and to the satisfaction of the FDA or foreign regulatory agencies, that such product candidates are safe and effective for their
intended uses. Results from preclinical studies and clinical trials can be interpreted in different ways. Even if we believe the preclinical
or clinical data for our product candidates are promising, such data may not be sufficient to support approval by the FDA and other regulatory
authorities.
The FDA or any foreign regulatory bodies can
delay, limit or deny approval of our product candidates or require us to conduct additional preclinical or clinical testing or abandon
a program for many reasons, including:
| |
● |
the FDA or comparable foreign
regulatory authorities may disagree with the design or implementation of our clinical trials; |
| |
● |
the FDA or comparable foreign
regulatory authorities may disagree with our safety interpretation of our product candidate; |
| |
● |
the FDA or comparable foreign
regulatory authorities may disagree with our efficacy interpretation of our product candidate; |
| |
● |
the FDA or comparable foreign
regulatory authorities may regard our CMC package as inadequate. |
Of the large number of drugs in development,
only a small percentage successfully complete the regulatory approval processes and are commercialized. This lengthy approval process,
as well as the unpredictability of future clinical trial results, may result in our failing to obtain regulatory approval to market our
Product Candidates or another product candidate, which would significantly harm our business, results of operations and prospects.
In addition, the FDA or the applicable foreign
regulatory agency also may approve a product candidate for a more limited indication or patient population than we originally requested,
and the FDA or applicable foreign regulatory agency may approve a product candidate with a label that does not include the labeling claims
necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially
harm the commercial prospects for our product candidates.
If we are unable to file for approval of
Epoladerm and Probudur under Section 505(b)(2) of the FDCA or if we are required to generate additional data related to safety and
efficacy in order to obtain approval under Section 505(b)(2), we may be unable to meet our anticipated development and commercialization
timelines.
Our current plans for filing NDAs for Epoladerm
and Probudur include efforts to minimize the data we will be required to generate in order to obtain marketing approval and therefore
reduce the development time. We intend to file Section 505(b)(2) NDAs for Epoladerm and Probudur that might, if accepted by the
FDA, save time and expense in the development and testing of these indications.
The timeline for filing and review of our NDAs
for Epoladerm and Probudur is based on our plan to submit each of the NDAs under Section 505(b)(2) of the FDCA, which would enable
us to rely in part on data in the public domain or elsewhere. We have not yet filed an NDA under Section 505(b)(2) for any of our
product candidates. Depending on the data that may be required by the FDA for approval, some of the data may be related to products already
approved by the FDA. If the data relied upon is related to products already approved by the FDA and covered by third-party patents, we
would be required to certify that we do not infringe the listed patents or that such patents are invalid or unenforceable. As a result
of the certification, the third-party would have 45 days from notification of our certification to initiate an action against us.
In the event that an action is brought in response to such a certification, the approval of our NDA could be subject to a stay of up
to 30 months or more while we defend against such a suit. Approval of our product candidates under Section 505(b)(2) may therefore
be delayed until patent exclusivity expires or until we successfully challenge the applicability of those patents to our product candidates.
Alternatively, we may elect to generate sufficient additional clinical data so that we no longer rely on data which triggers a potential
stay of the approval of our product candidates. Even if no exclusivity periods apply to our applications under Section 505(b)(2),
the FDA has broad discretion to require us to generate additional data on the safety and efficacy of our product candidates to supplement
third-party data on which we may be permitted to rely. In either event, we could be required, before obtaining marketing approval for
any of our product candidates, to conduct substantial new research and development activities beyond those we currently plan to engage
in order to obtain approval of our product candidates. Such additional new research and development activities would be costly and time
consuming.
We may not be able to realize a shortened development
timeline for Epoladerm and Probudur, and the FDA may not approve either of our NDAs based on their review of the submitted data. Moreover,
if products containing the reference drug are withdrawn from the market by the FDA for any safety reason, we may not be able to reference
such products to support a 505(b)(2) NDA for our product candidates, and we may need to fulfill the more extensive requirements of Section 505(b)(1).
If we are required to generate additional data to support approval, we may be unable to meet our anticipated development and commercialization
timelines, may be unable to generate the additional data at a reasonable cost, or at all, and may be unable to obtain marketing approval
of our lead product candidate.
Enrollment and retention of patients in
clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors
outside our control.
The timely completion of clinical trials in accordance
with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until
its conclusion. We may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our
clinical trials, and even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our trials. Patient
enrollment and retention in clinical trials depends on many factors, including:
| |
● |
the patient eligibility
criteria defined in the protocol; |
| |
● |
the size of the patient
population required for analysis of the trial’s primary endpoints; |
| |
● |
the nature of the trial
protocol; |
| |
● |
the existing body of safety
and efficacy data with respect to the product candidate; |
| |
● |
the proximity of patients
to clinical sites; |
| |
● |
our ability to recruit
clinical trial investigators with the appropriate competencies and experience; |
| |
● |
clinicians’ and patients’
perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including
any new drugs that may be approved for the indications we are investigating; |
| |
● |
competing clinical trials
being conducted by other companies or institutions; |
| |
● |
our ability to maintain
patient consents; and |
| |
● |
the risk that patients
enrolled in clinical trials will drop out of the trials before completion. |
The resurgence of COVID-19 pandemic could
adversely affect our business or another health epidemic or pandemic may have an adverse impact on our business in the future.
Our business, including our workforce, supply chain and disruption
of our preclinical studies and clinical trials, could be adversely affected by a resurgence of COVID-19 or another health epidemic or
pandemic may adversely affect us in the future. It is possible that a resurgence of COVID-19 or another epidemic or pandemic will adversely
affect our business, our workforce, our supply chains, preclinical studies and clinical trials or otherwise impact our ability to conduct
business in the future. In addition, we rely on independent clinical investigators, contract research organizations and other third-party
service providers to assist us in managing, monitoring and otherwise carrying out our preclinical studies and clinical trials, and a resurgence
of COVID-19 or another epidemic pandemic may affect their ability to devote sufficient time and resources to our programs. We also rely
on third party suppliers and contract manufacturers to produce the drug product we utilize in our clinical trials, and to the extent their
businesses are adversely affected by such occurrences, they might cause delays in the delivery of raw materials and drug product or impact
our ability to meet development timelines, which could adversely affect our results of operations. Temporary closure of facilities at
which our clinical or preclinical trials are conducted, or restrictions on the ability of our employees, clinicians or patients enrolled
in our trials to travel could adversely affect our operations and our ability to conduct and complete our preclinical and clinical trials.
The effects of ongoing or future health epidemics on our business remain uncertain and subject to change.
Results of preclinical studies, early clinical
trials or analyses may not be indicative of results obtained in later trials.
The results of preclinical studies, early clinical
trials or analyses of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates
in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical
studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced
clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. In addition,
conclusions based on promising data from analyses of clinical results may be shown to be incorrect when implemented in prospective clinical
trials. Even if our clinical trials for our Product Candidates are completed as planned, we cannot be certain that their results will
support the safety and efficacy sufficient to obtain regulatory approval.
Interim “top-line” and preliminary
data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are
subject to audit and verification procedures that could result in material changes in the final data.
From time to time, we may publish interim “top-line”
or preliminary data from our clinical studies. Interim data from clinical trials that we may complete are subject to the risk that one
or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary
or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially
different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution
until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our
business prospects.
Our product candidates may cause serious
adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken
off the market, require them to include safety warnings or otherwise limit their sales.
Serious adverse events or undesirable side effects
caused by our Product Candidates or any other 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 other comparable
foreign authorities. Results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects
or unexpected characteristics. Any clinical trials for our drug product candidates which include our Product Candidates to date may fail
to demonstrate acceptable levels of safety and efficacy which could prevent or significantly delay their regulatory approval or result
in a more restrictive label by the FDA or other comparable foreign authorities.
If unacceptable side effects arise in the development
of our product candidates, we, the FDA or the IRBs at the institutions in which our studies are conducted, or the DSMB, if constituted
for our clinical trials, could recommend a suspension or termination of our clinical trials, or the FDA or comparable foreign regulatory
authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications.
In addition, drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete a trial or result
in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating
medical staff. We expect to have to train medical personnel using our product candidates to understand the side effect profiles for our
clinical trials and upon any commercialization of any of our product candidates. Inadequate training in recognizing or managing the potential
side effects of our product candidates could result in patient injury or death. Any of these occurrences may harm our business, financial
condition and prospects significantly.
Additionally, if one or more of our product candidates
receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially
significant negative consequences could result, including:
| |
● |
regulatory authorities
may withdraw approvals of such product; |
| |
● |
regulatory authorities
may require additional warnings on the label, such as a “black box” warning or contraindication; |
| |
● |
additional restrictions
may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof; |
| |
● |
we may be required to implement
a Risk Evaluation and Mitigation Strategy (“REMS”) or create a medication guide outlining the risks of such side effects
for distribution to patients; |
| |
● |
we could be sued and held
liable for harm caused to patients; |
| |
● |
the product may become
less competitive; and |
| |
● |
our reputation may suffer. |
Any of these events could prevent us from achieving
or maintaining market acceptance of a product candidate, if approved, and could significantly harm our business, results of operations
and prospects.
The market opportunities for our Product
Candidates, if approved, may be smaller than we anticipate.
We expect to initially seek approval for Probudur for postoperative
pain management, Envelta for severe pain including post cancer pain, NobrXiol to potentially treat seizures associated with Lennox-Gastaut
syndrome and Dravet syndrome in pediatric patients two years of age and older in the United States, AnQlar as an antiviral barrier
to potentially prevent or reduce the risk or the intensity of viral infections in humans, including, but not limited to, influenza and
SARS-CoV-2 (COVID 19), and Epoladerm for Osteoarthritis pain. Our estimates of market potential have been derived from a variety of sources,
including scientific literature, patient foundations, and market research, and may prove to be incorrect. Even if we obtain significant
market share for any product candidate, if approved, if the potential target populations are smaller than we anticipate, we may never
achieve profitability without obtaining marketing approval for additional indications. In addition, our strategy for AnQlar and Epoladerm
is to license out or partner this asset as we continue to focus our efforts on our prescription drug pipeline, which may result in shared
revenue.
We have never obtained marketing approval
for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates.
We have never obtained marketing approval for
a product candidate. It is possible that the FDA may refuse to accept for substantive review any NDAs that we submit for our product
candidates or may conclude after review of our data that our application is insufficient to obtain marketing approval of our product
candidates. If the FDA does not accept or approve our NDAs for our product candidates, it may require that we conduct additional clinical,
preclinical, or manufacturing validation studies and submit that data before it will reconsider our applications. Depending on the extent
of these or any other FDA-required studies, approval of any NDA that we submit may be delayed or may require us to expend more resources
than we have available. It is also possible that additional studies, if performed and completed, may not be considered sufficient by
the FDA to approve our NDAs.
Any delay in obtaining, or an inability to obtain,
marketing approvals would prevent us from commercializing our product candidates, generating revenues, and achieving and sustaining profitability.
If any of these outcomes occur, we may be forced to abandon our development efforts for our product candidates, which could significantly
harm our business.
Even if we obtain FDA approval for our
Product Candidates or any other product candidate in the United States, we may never obtain approval for or commercialize our Product
Candidates or any other product candidate in any other jurisdiction, which would limit our ability to realize their full market potential.
In order to market any products in any particular
jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding
safety and efficacy. Approval by the FDA in the United States does not ensure approval by regulatory authorities in other countries
or jurisdictions. However, the failure to obtain approval in one jurisdiction may negatively impact our ability to obtain approval elsewhere.
In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory
approval in one country does not guarantee regulatory approval in any other country.
Approval processes vary among countries and can
involve additional product testing and validation and additional administrative review periods. Seeking foreign regulatory approval could
result in difficulties and increased costs for us and require additional preclinical 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
products in those countries. We do not have any product candidates approved for sale in any jurisdiction, including in 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 approvals in international markets
are delayed, our target market will be reduced and our ability to realize the full market potential of any product we develop will be
unrealized.
Even if we obtain regulatory approval for
our Product Candidates or any product candidate, we will still face extensive and ongoing regulatory requirements and obligations and
any product candidates, if approved, may face future development and regulatory difficulties.
Any product candidate for which we obtain marketing
approval, along with the manufacturing processes, post-approval clinical data, labeling, packaging, distribution, adverse event reporting,
storage, recordkeeping, export, import, advertising and promotional activities for such product, among other things, will be subject
to extensive and ongoing requirements of and review by the FDA and other regulatory authorities. These requirements include submissions
of safety and other post-marketing information and reports, establishment registration and drug listing requirements, continued compliance
with cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents,
requirements regarding the distribution of samples to physicians and recordkeeping and Good Clinical Practice (“GCP”) requirements
for any clinical trials that we conduct post-approval.
Even if marketing approval of a product candidate
is granted, the approval may be subject to limitations on the indicated uses for which the product candidate may be marketed or to the
conditions of approval, including a requirement to implement a REMS. If any of our product candidates receive marketing approval, the
accompanying label may limit the approved indicated use of the product candidate, which could limit sales of the product candidate. The
FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy
of a product. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the
approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’
communications regarding off-label use, and if we market our products for uses beyond their approved indications, we may be subject to
enforcement action for off-label marketing. Violations of the FDCA relating to the promotion of prescription drugs may lead to FDA enforcement
actions and investigations alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer protection
laws.
In addition, later discovery of previously unknown
adverse events or other problems with our products, manufacturers or manufacturing processes or failure to comply with regulatory requirements,
may yield various results, including:
| |
● |
restrictions on manufacturing
such products; |
| |
● |
restrictions on the labeling
or marketing of products; |
| |
● |
restrictions on product
distribution or use; |
| |
● |
requirements to conduct
post-marketing studies or clinical trials; |
| |
● |
warning letters or untitled
letters; |
| |
● |
withdrawal of the products
from the market; |
| |
● |
refusal to approve pending
applications or supplements to approved applications that we submit; |
| |
● |
fines, restitution or disgorgement
of profits or revenues; |
| |
● |
suspension or withdrawal
of marketing approvals; |
| |
● |
refusal to permit the import
or export of our products; |
| |
● |
injunctions or the imposition
of civil or criminal penalties. |
Further, the FDA’s policies may change,
and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not
able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our
business, prospects and ability to achieve or sustain profitability.
We also cannot predict the likelihood, nature
or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States
or abroad. For example, certain policies of the current presidential administration may impact our business and industry. Namely, the
current presidential administration has taken several executive actions, including the issuance of a number of Executive Orders, that
could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight
activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications.
It is difficult to predict how these executive actions will be implemented, and the extent to which they will impact the FDA’s
ability to exercise its regulatory authority. If these executive actions impose constraints on FDA’s ability to engage in oversight
and implementation activities in the normal course, our business may be negatively impacted.
Potential product liability lawsuits against
us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
The use of our Product Candidates or any other
product candidates we may develop in clinical trials and the sale of any products for which we obtain marketing approval exposes us to
the risk of product liability claims. Product liability claims might be brought against us by patients, healthcare providers, pharmaceutical
companies or others selling or otherwise coming into contact with our products. On occasion, large judgments have been awarded in class action
lawsuits based on drugs that had unanticipated adverse effects. If we cannot successfully defend against product liability claims, we
could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result
in:
| |
● |
impairment of our business
reputation and significant negative media attention; |
| |
● |
withdrawal of participants
from our clinical trials; |
| |
● |
significant costs to defend
the litigation; |
| |
● |
distraction of management’s
attention from our primary business; |
| |
● |
substantial monetary awards
to patients or other claimants; |
| |
● |
inability to commercialize
our Product Candidates or any other product candidate; |
| |
● |
product recalls, withdrawals,
or labeling, marketing, or promotional restrictions; |
| |
● |
decreased market demand
for any product; and |
Risks Related to Commercialization
We face significant competition from other
biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
The biopharmaceutical and pharmaceutical industries
are highly competitive and subject to significant and rapid technological change. Our success is highly dependent on our ability to acquire,
develop, and obtain marketing approval for new products on a cost-effective basis and to market them successfully. If any of our Product
Candidates are approved, we will face intense competition from a variety of businesses, including large, fully integrated pharmaceutical
companies, specialty pharmaceutical companies and biopharmaceutical companies in the United States and other jurisdictions. These
organizations may have significantly greater resources than we do and may conduct similar research; seek patent protection; and establish
collaborative arrangements for research, development, manufacturing and marketing of products that may compete with us.
Our competitors may, among other things:
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have significantly greater
name recognition, financial, manufacturing, marketing, drug development, technical, and human resources than we do, and future mergers
and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors; |
| |
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develop and commercialize
products that are safer, more effective, less expensive, more convenient, or easier to administer, or have fewer or less severe effects; |
| |
● |
obtain quicker regulatory
approval; |
| |
● |
implement more effective
approaches to sales and marketing; or |
| |
● |
form more advantageous
strategic alliances. |
Smaller and other early-stage companies may also
prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third
parties compete with us in recruiting and retaining qualified scientific and management personnel; establishing clinical trial sites
and patient registration; and in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunity
could be reduced or eliminated if our competitors develop and commercialize products that are more effective, have fewer or less severe
side effects, or are more convenient or are less expensive than our Product Candidates. Our competitors may also obtain FDA or other
regulatory approval for their product candidates more rapidly than we may obtain approval for our Product Candidates, which could result
in our competitors establishing or strengthening their market position before we are able to enter the market.
The successful commercialization of our
Product Candidates and any other product candidate we develop will depend in part on the extent to which governmental authorities and
health insurers establish adequate coverage, reimbursement levels, and pricing policies. Failure to obtain or maintain coverage and adequate
reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate
revenue.
The availability and adequacy of coverage and
reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party payors
are essential for most patients to be able to afford prescription medications such as our Product Candidates, if approved. Our ability
to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other
organizations will have an effect on our ability to successfully commercialize our drug and any other product candidates we develop.
Assuming we obtain coverage for our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate
or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the United States
or elsewhere will be available for our product candidates or any product that we may develop, and any reimbursement that may become available
may be decreased or eliminated in the future.
Third-party payors increasingly are challenging
prices charged for pharmaceutical products and services, and many third-party payors may refuse to provide coverage and reimbursement
for particular drugs or biologics when an equivalent generic drug, biosimilar, or a less expensive therapy is available. It is possible
that a third-party payor may consider our product candidates as substitutable and offer to reimburse patients only for the less expensive
product. Even if we show improved efficacy or improved convenience of administration with our product candidates, pricing of existing
drugs may limit the amount we will be able to charge for our product candidates. These payors may deny or revoke the reimbursement status
of a given product or establish prices for new or existing marketed products at levels that are too low to enable us to realize an appropriate
return on our investment in our product candidates. If reimbursement is not available or is available only at limited levels, we may
not be able to successfully commercialize our product candidates and may not be able to obtain a satisfactory financial return on our
product candidates.
There is significant uncertainty related to the
insurance coverage and reimbursement of newly approved products. In the United States, third-party payors, including private and
governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs
and biologics will be covered. The Medicare and Medicaid programs increasingly are used as models in the United States for how private
payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. Some third-party payors
may require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers
who use such therapies. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and
reimbursement for our product candidates.
No uniform policy for coverage and reimbursement
for products exists among third-party payors in the United States. Therefore, coverage and reimbursement for products can differ
significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that
will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance
that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Furthermore, rules and regulations
regarding reimbursement change frequently, in some cases at short notice, and we believe that changes in these rules and regulations
are likely.
We may also be subject to extensive governmental
price controls and other market regulations outside of the United States, and we believe the increasing emphasis on cost-containment
initiatives in other countries have and will continue to put pressure on the pricing and usage of medical products. In many countries,
the prices of medical products are subject to varying price control mechanisms as part of national health systems. Other countries allow
companies to fix their own prices for medical products but monitor and control company profits.
Additional foreign price controls or other changes
in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside
the United States, the reimbursement for our product candidates may be reduced compared with the United States and may be insufficient
to generate commercially reasonable revenue and profits.
Moreover, increasing efforts by governmental
and third-party payors in the United States to cap or reduce healthcare costs may cause such organizations to limit both coverage
and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product
candidates. We expect to experience pricing pressures in connection with the sale of our product candidates due to the trend toward managed
health care, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on
healthcare costs in general, particularly prescription drugs and biologics and surgical procedures and other treatments, has become intense.
As a result, increasingly high barriers are being erected to the entry of new products.
Even if our Product Candidates or any product
candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors
or others in the medical community necessary for commercial success.
If our Product Candidates or any product candidate
we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party
payors, and others in the medical community. If it does not achieve an adequate level of acceptance, we may not generate significant
product revenues or become profitable. The degree of market acceptance of our product candidates, if approved, will depend on a number
of factors, including but not limited to:
| |
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the efficacy and potential
advantages compared to alternative treatments; |
| |
● |
effectiveness of sales
and marketing efforts; |
| |
● |
the cost of treatment in
relation to alternative treatments, including any similar generic treatments; |
| |
● |
our ability to offer our
products for sale at competitive prices; |
| |
● |
the convenience and ease
of administration compared to alternative treatments; |
| |
● |
the willingness of the
target patient population to try new therapies and of physicians to prescribe these therapies; |
| |
● |
the strength of marketing
and distribution support; |
| |
● |
the availability of third-party
coverage and adequate reimbursement; |
| |
● |
the prevalence and severity
of any side effects; and |
| |
● |
any restrictions on the
use of our product together with other medications. |
Because we expect sales of our product candidates,
if approved, to generate substantially all of our revenues for the foreseeable future, the failure of our product candidates to find
market acceptance would harm our business and could require us to seek additional financing.
If we are unable to establish sales, marketing,
and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing our
Product Candidates, if approved.
We do not have any infrastructure for the sales,
marketing, or distribution of our Product Candidates, and the cost of establishing and maintaining such an organization may exceed the
cost-effectiveness of doing so. In order to market and successfully commercialize our drug or any product candidate we develop, if approved,
we must build our sales, distribution, marketing, managerial and other non-technical capabilities or make arrangements with third parties
to perform these services. We expect to build a focused sales distribution and marketing infrastructure to market our Product Candidates,
if approved, in the United States and Europe. There are significant expenses and risks involved with establishing our own sales,
marketing and distribution capabilities, including our ability to hire, retain and appropriately incentivize qualified individuals, generate
sufficient sales leads, provide adequate training to sales and marketing personnel and effectively manage a geographically dispersed
sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities could
delay any product launch, which would adversely impact the commercialization of that product. For example, if the commercial launch of
our Product Candidates for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason,
we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be
lost if we cannot retain or reposition our sales and marketing personnel.
Factors that may inhibit our efforts to commercialize
our product candidates on our own include:
| |
● |
our inability to recruit,
train and retain adequate numbers of effective sales and marketing personnel; |
| |
● |
the inability of sales
personnel to obtain access to physicians or attain adequate numbers of physicians to prescribe our products; and |
| |
● |
unforeseen costs and expenses
associated with creating an independent sales and marketing organization. |
We do not anticipate having the resources in
the foreseeable future to allocate to the sales and marketing of our product candidates, if approved, in certain markets overseas. Therefore,
our future success will depend, in part, on our ability to enter into and maintain collaborative relationships for such capabilities,
the collaborator’s strategic interest in a product and such collaborator’s ability to successfully market and sell the product.
We intend to pursue collaborative arrangements regarding the sale and marketing of our Product Candidates, if approved, for certain markets
overseas; however, we cannot assure you that we will be able to establish or maintain such collaborative arrangements, or if able to
do so, that they will have effective sales forces. To the extent that we depend on third parties for marketing and distribution, any
revenues we receive will depend upon the efforts of such third parties, and there can be no assurance that such efforts will be successful.
If we are unable to build our own sales force
or negotiate a collaborative relationship for the commercialization of our Product Candidates, we may be forced to delay the potential
commercialization of the drug or reduce the scope of our sales or marketing activities. If we need to increase our expenditures to fund
commercialization activities for our Product Candidates we will need to obtain additional capital, which may not be available to us on
acceptable terms, or at all. We may also have to enter into collaborative arrangements for our Product Candidates at an earlier stage
than otherwise would be ideal and we may be required to relinquish rights to it or otherwise agree to terms unfavorable to us. Any of
these occurrences may have an adverse effect on our business, operating results, and prospects.
If we are unable to establish adequate sales,
marketing, and distribution capabilities, either on our own or in collaboration with third parties, we will not be successful in commercializing
our product candidates and may never become profitable. We will be competing with many companies that currently have extensive and well-funded
marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, we
may be unable to compete successfully against these more established companies.
A variety of risks associated with operating
internationally could materially adversely affect our business.
We currently have no international operations,
aside from the development of our product candidates by companies that operate internationally, but our business strategy includes potentially
expanding internationally if any of our product candidates receive regulatory approval. Doing business internationally involves a number
of risks, including but not limited to:
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multiple, conflicting and
changing laws and regulations, such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory
requirements and other governmental approvals, permits and licenses; |
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failure by us to obtain
and maintain regulatory approvals for the use of our products in various countries; |
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additional potentially
relevant third-party patent rights; |
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complexities and difficulties
in obtaining protection and enforcing our intellectual property; |
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difficulties in staffing
and managing foreign operations; |
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complexities associated
with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; |
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limits in our ability to
penetrate international markets; |
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financial risks, such as
longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and
payment for our products and exposure to foreign currency exchange rate fluctuations; |
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natural disasters, political
and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and
other business restrictions; |
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certain expenses including,
among others, expenses for travel, translation and insurance; and |
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regulatory and compliance
risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the
U.S. Foreign Corrupt Practices Act, its books and records provisions, or its anti-bribery provisions. |
Any of these factors could significantly harm
any future international expansion and operations and, consequently, our results of operations.
Risks Related to Our Dependence on Third Parties
Our employees and independent contractors,
including principal investigators, CROs, consultants, vendors, and any third parties we may engage in connection with development and
commercialization, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements,
which could have a material adverse effect on our business.
Our employees and independent contractors, including
principal investigators, consultants, vendors and any third parties we may engage in connection with development and commercialization
of our product candidates, could engage in misconduct, including intentional, reckless or negligent conduct or unauthorized activities
that violate: the laws and regulations of the FDA or other similar regulatory requirements of other authorities, including those laws
that require the reporting of true, complete and accurate information to such authorities; manufacturing standards; data privacy, security,
fraud and abuse and other healthcare laws and regulations; or laws that require the reporting of true, complete and accurate financial
information and data. Specifically, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws
and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations
may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs
and other business arrangements. Activities subject to these laws could also involve the improper use or misrepresentation of information
obtained in the course of clinical trials, creation of fraudulent data in preclinical studies or clinical trials or illegal misappropriation
of drug product, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify
and deter misconduct by employees and other third parties, and the precautions We take to detect and prevent this activity may not be
effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or
lawsuits stemming from a failure to comply with such laws or regulations. Additionally, we are subject to the risk that a person or government
could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us and we are not successful
in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations,
including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgements, possible
exclusion from participation in Medicare, Medicaid, other U.S. federal healthcare programs or healthcare programs in other jurisdictions,
individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings, and curtailment
of our operations.
We currently rely on third-party contract
manufacturing organizations (“CMOs”) for the production of clinical supply of our Product Candidates and intend to rely on
CMOs for the production of commercial supply of our Product Candidates, if approved. Our dependence on CMOs may impair the development
and commercialization of the drug, which would adversely impact our business and financial position.
We have limited personnel with experience in
manufacturing, and we do not own facilities for manufacturing. Instead, we rely on and expect to continue to rely on CMOs for the supply
of cGMP grade clinical trial materials and commercial quantities of our Product Candidates and any product candidates we develop, if
approved. Reliance on CMOs may expose us to more risk than if we were to manufacture our product candidates ourselves. We intend to have
manufactured a sufficient clinical supply of our Product Candidates drug substance to enable us to complete our clinical trials, and
we have engaged or intend to engage a CMO to provide clinical and commercial supplies of the drug products.
The facilities used to manufacture our product
candidates must be inspected by the FDA and comparable foreign authorities. While we provide oversight of manufacturing activities, we
do not and will not control the execution of manufacturing activities by, and are or will be essentially dependent on, our CMOs for compliance
with cGMP requirements for the manufacture of our product candidates. As a result, we are subject to the risk that our product candidates
may have manufacturing defects that we have limited ability to prevent. If a CMO cannot successfully manufacture material that conforms
to our specifications and the regulatory requirements, we will not be able to secure or maintain regulatory approval for the use of our
product candidates in clinical trials, or for commercial distribution of our product candidates, if approved. In addition, we have limited
control over the ability of our CMOs to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or comparable
foreign regulatory authority finds deficiencies with or does not approve these facilities for the manufacture of our product candidates
or if it withdraws any such approval or finds deficiencies in the future, we may need to find alternative manufacturing facilities, which
would delay our development program and significantly impact our ability to develop, obtain regulatory approval for or commercialize
our product candidates, if approved. In addition, any failure to achieve and maintain compliance with these laws, regulations and standards
could subject us to the risk that we may have to suspend the manufacture of our product candidates or that obtained approvals could be
revoked. Furthermore, CMOs may breach existing agreements they have with us because of factors beyond our control. They may also terminate
or refuse to renew their agreement at a time that is costly or otherwise inconvenient for us. If we were unable to find an adequate CMO
or another acceptable solution in time, our clinical trials could be delayed, or our commercial activities could be harmed.
We rely on and will continue to rely on CMOs
to purchase from third-party suppliers the raw materials necessary to produce our product candidates. We do not and will not have control
over the process or timing of the acquisition of these raw materials by our CMOs. Moreover, we currently only have one agreement for
the production of these raw materials (for AnQlar). Supplies of raw material could be interrupted from time to time and we cannot be
certain that alternative supplies could be obtained within a reasonable timeframe, at an acceptable cost, or at all. In addition, a disruption
in the supply of raw materials could delay the commercial launch of our product candidates, if approved, or result in a shortage in supply,
which would impair our ability to generate revenues from the sale of our product candidates. Growth in the costs and expenses of raw
materials may also impair our ability to cost effectively manufacture our product candidates. There are a limited number of suppliers
for the raw materials that we may use to manufacture our product candidates and we may need to assess alternative suppliers to prevent
a possible disruption of the manufacture of our product candidates.
Finding new CMOs or third-party suppliers involves
additional cost and requires our management’s time and focus. In addition, there is typically a transition period when a new CMO
commences work. Although we generally have not, and do not intend to, begin a clinical trial unless we believe we have on hand, or will
be able to obtain, a sufficient supply of our product candidates to complete the clinical trial, any significant delay in the supply
of our product candidates or the raw materials needed to produce our product candidates, could considerably delay conducting our clinical
trials and potential regulatory approval of our product candidates.
As part of their manufacture of our product candidates,
our CMOs and third-party suppliers are expected to comply with and respect the proprietary rights of others. If a CMO or third-party
supplier fails to acquire the proper licenses or otherwise infringes the proprietary rights of others in the course of providing services
to us, we may have to find alternative CMOs or third-party suppliers or defend against claims of infringement, either of which would
significantly impact our ability to develop, obtain regulatory approval for or commercialize our product candidates, if approved.
We intend to rely on third parties to conduct,
supervise and monitor our clinical trials. If those third parties do not successfully carry out their contractual duties, or if they
perform in an unsatisfactory manner, it may harm our business.
We rely, and will continue to rely, on CROs,
CRO-contracted vendors and clinical trial sites to ensure the proper and timely conduct of our clinical trials. Our reliance on CROs
for clinical development activities limits our control over these activities, but we remain responsible for ensuring that each of our
trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards.
We and our CROs will be required to comply with
the Good Laboratory Practice (“GLP”) requirements for our preclinical studies and GCP requirements for our clinical trials,
which are regulations and guidelines enforced by the FDA and are also required by comparable foreign regulatory authorities. Regulatory
authorities enforce GCP requirements through periodic inspections of trial sponsors, principal investigators and clinical trial sites.
If we or our CROs fail to comply with GCP requirements, 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 clinical trials before approving our marketing
applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that
any of our clinical trials comply with GCP requirements. In addition, our clinical trials must be conducted with product produced under
cGMP requirements. Accordingly, if our CROs fail to comply with these requirements, we may be required to repeat clinical trials, which
would delay the regulatory approval process.
Our CROs are not our employees, and we do not
control whether or not they devote sufficient time and resources to our clinical trials. Our CROs may also have relationships with other
commercial entities, including our competitors, for whom they may also be conducting clinical trials, or other drug development activities,
which could harm our competitive position. We face the risk of potential unauthorized disclosure or misappropriation of our intellectual
property by CROs, which may reduce our trade secret protection and allow our potential competitors to access and exploit our proprietary
technology. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if
the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory
requirements or for any other reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory
approval for, or successfully commercialize any product candidate that we develop. As a result, our financial results and the commercial
prospects for any product candidate that we develop would be harmed, our costs could increase, and our ability to generate revenue could
be delayed.
If our relationship with any CROs terminate,
we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms. Switching or adding additional
CROs involves substantial cost and requires management’s time and focus. In addition, there is a natural transition period when
a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development
timelines. Though we intend to carefully manage our relationships with our CROs, there can be no assurance that we will not encounter
challenges or delays in the future or that these delays or challenges will not have an adverse impact on our business, financial condition
and prospects.
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the number and type of
our collaborations could adversely affect our attractiveness to future collaborators or acquirers; and |
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the loss of, or a disruption
in our relationship with, any one or more collaborators could harm our business. |
If any collaborations do not result in the successful
development and commercialization of products or if one of our collaborators terminates its agreement with us, we may not receive any
future research and development funding or milestone or royalty payments under such collaborations. If we do not receive the funding
we expect under these agreements, our continued development of our product candidates could be delayed, and we may need additional resources
to develop additional product candidates. All of the risks relating to product development, regulatory approval and commercialization
described in this Annual Report on Form 10-K also apply to the activities of any collaborators and there can be no assurance that our
collaborations will produce positive results or successful products on a timely basis or at all.
In addition, subject to its contractual obligations
to us, if one of our collaborators is involved in a business combination or otherwise changes its business priorities, the collaborator
might deemphasize or terminate the development or commercialization of our product candidates. If a collaborator terminates its agreement
with us, we may find it more difficult to attract new collaborators and the perception of our business and our stock price could be adversely
affected.
We may in the future collaborate with additional
pharmaceutical and biotechnology companies for development and potential commercialization of therapeutic products. We face significant
competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for a collaboration will depend, among
other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration
and the proposed collaborator’s evaluation of a number of factors. If we are unable to reach agreements with suitable collaborators
on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its
development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any
sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.
If we elect to fund and undertake development or commercialization activities on our own, we may need to obtain additional expertise
and additional capital, which may not be available to us on acceptable terms or at all. If we fail to enter into collaborations and do
not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to
further develop our product candidates or bring them to market or continue to develop our programs, and our business may be materially
and adversely affected.
Risks Related to Healthcare Laws and Other
Legal Compliance Matters
Enacted and future healthcare legislation
may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and
may affect the prices we may set.
In the United States and other jurisdictions,
there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the
healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives
at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, in March
2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively the
“ACA”) was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers.
Among the provisions of the ACA, those of greatest importance to the pharmaceutical and biotechnology industries include the following:
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an annual, non-deductible
fee payable by any entity that manufactures or imports certain branded prescription drugs and biologic agents (other than those designated
as orphan drugs), which is apportioned among these entities according to their market share in certain government healthcare programs; |
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a new Medicare Part D coverage
gap discount program, in which manufacturers must agree to offer point-of-sale discounts off negotiated prices of applicable brand
drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to
be covered under Medicare Part D; |
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new requirements to report
certain financial arrangements with physicians and teaching hospitals, including reporting “transfers of value” made
or distributed to prescribers and other healthcare providers and reporting investment interests held by physicians and their immediate
family members; |
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an increase in the statutory
minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; |
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a new methodology by which
rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs and biologics that are inhaled, infused,
instilled, implanted, or injected; |
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extension of a manufacturer’s
Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; |
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expansion of eligibility
criteria for Medicaid programs thereby potentially increasing a manufacturer’s Medicaid rebate liability; |
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a new Patient-Centered
Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with
funding for such research; |
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establishment of a Center
for Medicare Innovation at the Centers for Medicare & Medicaid Services, or CMS, to test innovative payment and service delivery
models to lower Medicare and Medicaid spending, potentially including prescription drug spending; |
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expansion of the entities
eligible for discounts under the Public Health Service program; and |
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a licensure framework for
follow on biologic products. |
Other legislative changes have been proposed
and adopted in the United States since the ACA was enacted. For example, the Budget Control Act of 2011, resulted in aggregate reductions
of Medicare payments to providers of 2% per fiscal year. These reductions went into effect in April 2013 and, due to subsequent legislative
amendments to the statute, will remain in effect through 2027 unless additional action is taken by Congress. In January 2013, the American
Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers,
including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government
to recover overpayments to providers from three to five years. Additionally, the orphan drug tax credit was reduced as part of a broader
tax reform. These new laws or any other similar laws introduced in the future may result in additional reductions in Medicare and other
health care funding, which could negatively affect our customers and accordingly, our financial operations.
Additionally, there has been heightened governmental
scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. On
September 9, 2021, the Biden Administration published a wide-ranging list of policy proposals, most of which would need to be carried
out by Congress, to reduce drug prices and drug payment. The United States Department of Health and Human Services (“HHS”)
plan includes, among other reform measures, proposals to lower prescription drug prices, including by allowing Medicare to negotiate
prices and disincentivizing price increases, and to support market changes that strengthen supply chains, promote biosimilars and generic
drugs, and increase price transparency. These initiatives recently culminated in the enactment of the Inflation Reduction Act (the
“IRA”) in August 2022, which will, among other things, allow the HHS to negotiate the selling price of certain drugs and
biologics that the Centers for Medicare & Medicaid Services (“CMS”) reimburses under Medicare Part B and Part D, although
only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for biologics) can be selected by CMS
for negotiation, with the negotiated price taking effect two years after the selection year. The negotiated prices, which will first
become effective in 2026, will be capped at a statutory ceiling price beginning in October 2023, penalize drug manufacturers that increase
prices of Medicare Part B and Part D drugs at a rate greater than the rate of inflation. The IRA permits the Secretary of HHS to implement
many of these provisions through guidance, as opposed to regulation, for the initial years. Manufacturers that fail to comply with the
IRA may be subject to various penalties, including civil monetary penalties. The IRA also extends enhanced subsidies for individuals
purchasing health insurance coverage in ACA marketplaces through plan year 2025. These provisions will take effect progressively starting
in 2023, although they may be subject to legal challenges.
Individual states in the United States have also
become increasingly aggressive in passing legislation and implementing 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.
Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations,
financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding
procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare
programs. This could reduce the ultimate demand for our product candidates or put pressure on our product pricing.
In markets outside of the United States, reimbursement
and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products
and therapies. We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or
administrative action in the United States or any other jurisdiction. If we or any third parties we may engage are slow or unable to
adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able
to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not
achieve or sustain profitability.
Our business operations and current and
future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers
will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
Our business operations and current and future
arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers, may
expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial
arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our product
candidates, if approved. Such laws include:
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the U.S. federal Anti-Kickback
Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving, or
providing any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, in cash
or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order, or recommendation
of, any good, facility, item, or service, for which payment may be made, in whole or in part, under U.S. federal and state healthcare
programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent
to violate it in order to have committed a violation. 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 hand; |
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the U.S. federal false
claims and civil monetary penalties laws, including the civil False Claims Act (the “FCA”) which, among other things,
impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for
knowingly presenting, or causing to be presented, to the U.S. federal government, claims for payment or approval that are false or
fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent
claim, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government.
In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback
Statute constitutes a false or fraudulent claim for purposes of the FCA. A claim includes “any request or demand” for
money or property presented to the federal government. In addition, manufacturers can be held liable under the FCA even when they
do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent
claims; |
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the U.S. federal Health
Insurance Portability and Accountability Act of 1996 (“HIPAA”), which imposes criminal and civil liability for, among
other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or
obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under
the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully
falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of,
or payment for, healthcare benefits, items or services. Similar to the U.S. federal Anti-Kickback Statute, a person or entity does
not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; |
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HIPAA, as amended by the
Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their respective implementing
regulations, which impose, among other things, specified requirements relating to the privacy, security and transmission of individually
identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans,
healthcare clearinghouses and healthcare providers as well as their business associates that perform certain services involving the
use or disclosure of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended
HIPAA to make civil and criminal penalties directly applicable to business associates and gave state attorneys general new authority
to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees
and costs associated with pursuing federal civil actions; |
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the FDCA, which prohibits,
among other things, the adulteration or misbranding of drugs, biologics and medical devices; |
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the U.S. federal legislation
commonly referred to as the Physician Payments Sunshine Act, enacted as part of the ACA, and its implementing regulations, which
requires certain manufacturers of drugs, devices, biologics, and medical supplies that are reimbursable under Medicare, Medicaid,
or the Children’s Health Insurance Program to report annually to the government information related to certain payments and
other transfers of value to physicians and teaching hospitals, as well as ownership and investment interests held by the physicians
described above and their immediate family members; and |
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analogous U.S. state laws
and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not
limited to, research, distribution, sales, and marketing arrangements and claims involving healthcare items or services reimbursed
by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical
industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government,
or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations
that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and
other remuneration and items of value provided to healthcare professionals and entities; and state laws governing the privacy and
security of health information in certain circumstances, many of which differ from each other in significant ways and often are not
preempted by HIPAA, thus complicating compliance efforts. |
Because of the breadth of these laws and the
narrowness of the statutory exceptions and regulatory safe harbors available under such laws, it is possible that some of our business
activities, including our consulting agreements and other relationships with physicians and other healthcare providers, some of whom
receive stock or stock options as compensation for their services, could be subject to challenge under one or more of such laws. Ensuring
that our current and future internal operations and business arrangements with third parties comply with applicable healthcare laws and
regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do
not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare
laws and regulations.
If our operations are found to be in violation
of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to the imposition
of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare,
Medicaid and other federal healthcare programs, individual imprisonment, contractual damages, reputational harm, diminished profits and
future earnings, additional reporting requirements or oversight if we become subject to a corporate integrity agreement or similar agreement
to resolve allegations of non-compliance with these laws, and curtailment or restructuring of our operations, any of which could adversely
affect our ability to operate our business and our results of operations. If any of the physicians or other providers or entities with
whom we expect to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative
sanctions, including exclusions from government funded healthcare programs and imprisonment, which could affect our ability to operate
our business. Further, defending against any such actions can be costly, time-consuming and may require significant personnel resources.
Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.
Any clinical trial programs we conduct
or research collaborations we enter into in the European Economic Area may subject us to the General Data Protection Regulation.
If we conduct clinical trial programs or enter
into research collaborations in the European Economic Area, we may be subject to the General Data Protection regulation (“GDPR”).
The GDPR applies extraterritorially and implements stringent operational requirements for processors and controllers of personal data,
including, for example, high standards for obtaining consent from individuals to process their personal data, robust disclosures to individuals,
a comprehensive individual data rights regime, data export restrictions governing transfers of data from the European Union (the “EU”)
to other jurisdictions, short timelines for data breach notifications, limitations on retention of information, increased requirements
pertaining to health data, other special categories of personal data and coded data and additional obligations if we contract third-party
processors in connection with the processing of personal data. The GDPR provides that EU member states may establish their own laws and
regulations limiting the processing of personal data, including genetic, biometric or health data, which could limit our ability to use
and share personal data or could cause our costs to increase. If our or our partners’ or service providers’ privacy or data
security measures fail to comply with the GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement
notices requiring us to change the way we use personal data and/or fines of up to 20 million Euros or up to 4% of the total worldwide
annual turnover of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, negative
publicity, reputational harm and a potential loss of business and goodwill.
We are subject to environmental, health
and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance
or remediation activities.
Our operations, including our development, testing
and manufacturing activities, are subject to numerous environmental, health and safety laws and regulations. These laws and regulations
govern, among other things, the controlled use, handling, release and disposal of and the maintenance of a registry for, hazardous materials
and biological materials, such as chemical solvents, human cells, carcinogenic compounds, mutagenic compounds and compounds that have
a toxic effect on reproduction, laboratory procedures and exposure to blood-borne pathogens. If we fail to comply with such laws and
regulations, we could be subject to fines or other sanctions.
As with other companies engaged in activities
similar to ours, we face a risk of environmental liability inherent in our current and historical activities, including liability relating
to releases of or exposure to hazardous or biological materials. Environmental, health and safety laws and regulations are becoming more
stringent. We may be required to incur substantial expenses in connection with future environmental compliance or remediation activities,
in which case, the production efforts of our third-party manufacturers or our development efforts may be interrupted or delayed.
Risks Related to Our Intellectual Property
If we fail to comply with our obligations
under our existing intellectual property license, we risk losing the rights to our intellectual property.
Each of the material license agreements in which
we have engaged, including the license agreements with MedPharm Limited, LipoCureRx Ltd. And Nanomerics Ltd. has provisions by which
each of those companies could terminate the license agreements thereby terminating our access to the intellectual property licensed under
those agreements. Termination of these license agreements would prevent the commercialization of the products we are developing.
If we are unable to obtain and maintain
patent protection for our technology, products, and product candidates or if the scope of the patent protection obtained is not sufficiently
broad, we may not be able to compete effectively in our markets.
We rely upon a combination of patents, trade
secret protection and confidentiality agreements to protect the intellectual property related to our drug development programs and product
candidates. Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other
countries with respect to our Product Candidates and any future products and product candidates. We seek to protect our proprietary position
by filing patent applications in the United States and abroad related to our development programs, and product candidates. The patent
prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications
at a reasonable cost or in a timely manner.
If the patent applications we own or license
with respect to our development programs and product candidates fail to issue, if their breadth or strength of protection is threatened,
or if they fail to provide meaningful exclusivity for our Product Candidates or any future product candidates, it could dissuade companies
from collaborating with us to develop product candidates and threaten our ability to commercialize future product candidates. Any such
outcome could have a materially adverse effect on our business.
The patent position of biotechnology and pharmaceutical
companies generally is highly uncertain, involves complex legal 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 patent rights to the same extent as the laws of the United States.
For example, European patent law restricts the patentability of methods of treatment of the human body more than U.S. law does. However,
in certain instances, the laws of the United States are more restrictive than those of foreign countries. For example, a recent
series of Supreme Court Cases has narrowed the types of subject matter considered eligible for patenting.
Accordingly, certain diagnostic methods are considered
ineligible for patenting in the U.S. because they are directed to a “law of nature”. Further, publications of discoveries
in 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
we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the
first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value
of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect
our technology, products, or product candidates, in whole or in part, or patents being issued which effectively prevent others from commercializing
competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States
and other countries may diminish the value of our patents or narrow the scope of our patent protection.
The issuance of a patent is not conclusive as
to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices
in the United States and abroad. Such challenges may result in patent claims being narrowed, invalidated, held unenforceable, in
whole or in part, or reduced patent term. Such a result could limit our ability to stop others from using or commercializing similar or
identical technologies and products to ours. Moreover, patents have a limited lifespan. In the United States, the natural expiration
of a patent is generally 20 years from the earliest effective non-provisional filing date. While various extensions may be available,
the life of a patent is limited. Without patent protection for our current or future products, we may be open to competition from generic
versions of such products. Given the amount of time required for the development, testing and regulatory review of new products, 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 using or commercializing technologies or products similar
or identical to ours.
We may become subject to third parties’
claims alleging infringement of their patents and proprietary rights, or we may need to become involved in lawsuits to protect or enforce
our patents, which could be costly, time consuming, delay or prevent the development and commercialization of our products and product
candidates or put our patents and other proprietary rights at risk.
Our commercial success depends, in part, upon
our ability to develop, manufacture, market and sell our products and product candidates without alleged or actual infringement, misappropriation
or other violation of the patents and proprietary rights of third parties. Litigation relating to infringement or misappropriation of
patent and other intellectual property rights in the pharmaceutical and biotechnology industries is common, including patent infringement
lawsuits, interferences, oppositions, reexamination, derivation and post-grant proceedings before the U.S. Patent and Trademark Office
(“USPTO”), and corresponding foreign patent offices.
The various markets in which we plan to operate
are subject to frequent and extensive litigation regarding patents and other intellectual property rights. In addition, many companies
in intellectual property-dependent industries, including the biotechnology and pharmaceutical industries, have employed intellectual
property litigation as a means to gain an advantage over their competitors. Numerous U.S., European and other foreign issued patents
and pending patent applications, which are owned by third parties, exist in the fields in which we are developing products and product
candidates. Some claimants may have substantially greater resources than we do and may be able to sustain the costs of complex intellectual
property litigation to a greater degree and for longer periods of time than we could. In addition, patent holding companies that focus
solely on extracting royalties and settlements by enforcing patent rights may target us. As the biotechnology and pharmaceutical industries
expand and more patents are issued, the risk increases that our products and product candidates may be subject to claims of infringement
of the intellectual property rights of third parties.
We may be subject to third-party claims including
infringement, interference or derivation proceedings, post-grant review and inter partes review before the USPTO or similar adversarial
proceedings or litigation in other jurisdictions. Even if we believe such claims are without merit, a court of competent jurisdiction
could hold that these third-party patents are valid, enforceable and infringed, and the holders of any such patents may be able to block
our ability to commercialize the applicable product candidate unless we obtained a license under the applicable patents, or until such
patents expire or are finally determined to be invalid or unenforceable. These proceedings may also result in our patent claims being
invalidated, held unenforceable or narrowed in scope. Similarly, if ours or our licensors’ patents or patent applications are challenged
during interference or derivation proceedings, a court may hold that a third-party is entitled to certain patent ownership rights instead
of us. Further, if any third-party patents were held by a court of competent jurisdiction to cover aspects of our compositions, formulations,
methods of manufacture, or methods of treatment, prevention or use, the holders of any such patents may be able to block our ability to
develop and commercialize the applicable products and product candidates unless we obtained a license or until such patents expire or
are finally determined to be invalid or unenforceable. In addition, defending such claims would cause us to incur substantial expenses
and, if successful, could cause us to pay substantial damages, if we are found to be infringing a third party’s patent rights. If
we are found to have infringed such rights willfully, the damages may be enhanced and may include attorneys’ fees. Further, if a
patent infringement suit is brought against us or our third-party service providers, our development, manufacturing or sales activities
relating to the product or product candidate that is the subject of the suit may be delayed or terminated. As a result of patent infringement
claims, or in order to avoid potential infringement claims, we may choose to seek, or be required to seek, a license from the third party,
which may require us to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even
if a license can be obtained on acceptable terms, the rights may be nonexclusive, which could give our competitors access to the same
intellectual property rights. If we are unable to enter into a license on acceptable terms, we could be prevented from commercializing
one or more of our products and product candidates, forced to modify such products and product candidates, or to cease some aspect of
our business operations, which could harm our business significantly. Modifying our products and product candidates to design around third-party
intellectual property rights may result in significant cost or delay to us and could prove to be technically infeasible. Any of these
events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would
otherwise be able to devote to our business. In addition, if the breadth or strength of protection provided the patents and patent applications
we own or in-license is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current
or future products and product candidates.
If we were to initiate legal proceedings against
a third party to enforce a patent covering one of our products and product candidates, the defendant could counterclaim that our patent
is invalid or unenforceable. In patent litigation in the United States and in Europe, defendant counterclaims alleging invalidity
or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements,
for example, lack of eligibility, lack of written description, lack of novelty, obviousness or non-enablement. Third parties might allege
unenforceability of our patents because someone connected with prosecution of the patent withheld relevant information, or made a misleading
statement, during patent prosecution. The outcome of proceedings involving assertions of invalidity and unenforceability during patent
litigation is unpredictable. With respect to the validity of patents, 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 or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our products and product candidates.
Furthermore, our patents and other intellectual property rights also will not protect our technology if competitors design around our
protected technology without infringing our patents or other intellectual property rights.
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 view these announcements in a negative light,
the price of common stock could be adversely affected.
Finally, even if resolved in our favor, litigation
or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our
technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results
of hearings, motions or other interim proceedings or developments and if securities analysts or investors view these announcements in
a negative light, the price of our common stock could be adversely affected. Such litigation or proceedings could substantially increase
our operating losses and reduce our resources available for development activities. We may not have sufficient financial or other resources
to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or
proceedings more effectively than we can because of their substantially greater financial resources. Uncertainties resulting from the
initiation and continuation of patent litigation or other proceedings could have an adverse effect on our ability to compete in the marketplace.
We may not identify relevant third-party
patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability
to develop, manufacture and market our products and product candidates.
We cannot guarantee that any of our or our licensors’
patent searches or analyses, including but not limited to the identification of relevant patents, the scope of patent claims or the expiration
of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending
application in the United States, Europe and elsewhere that is relevant to or necessary for the commercialization of our products
and product candidates in any jurisdiction. Patent applications in the United States, Europe and elsewhere are published approximately
18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority
date. Therefore, patent applications covering our future products and product candidates, or their manufacture or use may currently be
unpublished. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended
in a manner that could cover our products and product candidates or the use thereof. 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. Our interpretation of the relevance or the
scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our products and product
candidates. We may incorrectly determine that our products and product candidates are not covered by a third-party patent or may incorrectly
predict whether a third party’s pending application will issue with claims of relevant scope. Our determination of the expiration
date of any patent in the United States, Europe or elsewhere that we consider relevant may be incorrect, which may negatively impact
our ability to develop and market our products and product candidates. Our failure to identify and correctly interpret relevant patents
may negatively impact our ability to develop and market our products and product candidates.
From time to time we may identify patents or
applications in the same general area as our products and product candidates. We may determine these third-party patents are irrelevant
to our business based on various factors including our interpretation of the scope of the patent claims and our interpretation of when
those patents expire. If the patents are asserted against us, however, a court may disagree with our determinations. Further, while we
may determine that the scope of claims that will issue from a patent application does not present a risk, it is difficult to accurately
predict the scope of claims that will issue from a patent application, our determination may be incorrect, and the issuing patent may
be asserted against us. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims.
If we fail in any such dispute, in addition to being forced to pay monetary damages, we may be temporarily or permanently prohibited
from commercializing our products and product candidates. We might, if possible, also be forced to redesign our products and product
candidates so that we no longer infringe the third-party intellectual property rights. Any of these events, even if we were ultimately
to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our
business.
Changes in patent laws or patent jurisprudence
could diminish the value of patents in general, thereby impairing our ability to protect our products and product candidates.
As is the case with other biopharmaceutical and
pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents
in the biopharmaceutical and pharmaceutical industries involve both technological complexity and legal complexity. Therefore, obtaining
and enforcing biopharmaceutical and pharmaceutical patents is costly, time-consuming and inherently uncertain. In addition, the America
Invents Act, or the AIA, which was passed in September 2011, resulted in significant changes to the U.S. patent system.
An important change introduced by the AIA is that,
as of March 16, 2013, the United States transitioned to a “first-inventor-to-file” system for deciding which party should
be granted a patent when two or more patent applications are filed by different parties claiming the same invention. A third party that
files a patent application in the USPTO after that date but before us could therefore be awarded a patent covering an invention of ours
even if we made the invention before it was made by the third party. This will require us to be cognizant going forward of the time from
invention to filing of a patent application, but circumstances could prevent us from promptly filing patent applications on our inventions.
Among some of the other changes introduced by
the AIA are changes that limit where a patentee may file a patent infringement suit and providing opportunities for third parties to
challenge any issued patent before the USPTO. This applies to all of our U.S. patents, even those effectively filed before March 16,
2013. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary
to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold
a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action.
Accordingly, a third party may attempt to use
the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a
defendant in a district court action. It is not clear what, if any, impact the AIA will have on the operation of our business. However,
the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned and in-licensed patent
applications and the enforcement or defense of our owned and in-licensed patents.
Additionally, the U.S. Supreme Court has ruled
on several patent cases in recent years either narrowing the scope of patent protection available in certain circumstances or weakening
the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents
in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions
by Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could
weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. Similarly,
the complexity and uncertainty of European patent laws has also increased in recent years. In addition, the European patent system is
relatively stringent in the type of amendments that are allowed during prosecution. Complying with these laws and regulations could limit
our ability to obtain new patents in the future that may be important for our business.
Obtaining and maintaining our patent protection
depends on 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 and annuity fees on any
issued patent are due to be paid to the USPTO, European Patent Office (“EPO”) and other foreign patent offices over the lifetime
of a patent. In addition, the USPTO, EPO and other foreign patent offices require compliance with a number of procedural, documentary,
fee payment and other similar provisions during the patent application process. While an inadvertent failure to make payment of such
fees or to comply with such provisions can in many cases be cured by payment of a late fee or by other means in accordance with the applicable
rules, there are situations in which such noncompliance will result in the abandonment or lapse of the patent or patent application,
and the partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment
or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment
of fees and failure to properly legalize and submit formal documents within prescribed time limits. If we or our licensors fail to maintain
the patents and patent applications covering our products and product candidates or if we or our licensors otherwise allow our owned
or licensed patents or patent applications to be abandoned or lapse, our competitors might be able to enter the market, which would hurt
our competitive position and could impair our ability to successfully commercialize our products and product candidates in any indication
for which they are approved.
We enjoy only limited geographical protection
with respect to certain patents and we may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting and defending patents covering
our products and product candidates in all countries throughout the world would be prohibitively expensive. Competitors may use our owned
and in-licensed technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further,
may export otherwise infringing products to territories where we and our licensors have patent protection, but enforcement is not as
strong as that in the United States or the Europe. These products may compete with our products and product candidates, and our
owned or in-licensed patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
In addition, we may decide to abandon national
and regional patent applications before grant. The grant proceeding of each national or regional patent is an independent proceeding
which may lead to situations in which applications might in some jurisdictions be refused by the relevant patent offices, while granted
by others. For example, unlike other countries, China has a heightened requirement for patentability, and specifically requires a detailed
description of medical uses of a claimed drug. Furthermore, generic drug manufacturers or other competitors may challenge the scope,
validity or enforceability of our owned and in-licensed patents, requiring us or our licensors to engage in complex, lengthy and costly
litigation or other proceedings. Generic drug manufacturers may develop, seek approval for and launch generic versions of our products.
It is also quite common that depending on the country, the scope of patent protection may vary for the same product candidate or technology.
The laws of some jurisdictions do not protect
intellectual property rights to the same extent as the laws or rules and regulations in the United States and Europe, and many companies
have encountered significant difficulties in protecting and defending such rights in such jurisdictions. The legal systems of certain
countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property
protection, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation
of our proprietary rights generally. Proceedings to enforce our patent rights in other jurisdictions, whether or not successful, could
result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of
being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert
claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be
commercially meaningful. 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. Furthermore, while we intend to protect
our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar
efforts in all jurisdictions in which we may wish to market our product candidates. Accordingly, our efforts to protect our intellectual
property rights in such countries may be inadequate, which may have an adverse effect on our ability to successfully commercialize our
product candidates in all of our expected significant foreign markets. If we or our licensors encounter difficulties in protecting, or
are otherwise precluded from effectively protecting, the intellectual property rights important for our business in such jurisdictions,
the value of these rights may be diminished, and we may face additional competition from others in those jurisdictions.
Some countries also have compulsory licensing
laws under which a patent owner may be compelled to grant licenses to third parties. In addition, some countries limit the enforceability
of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which
could materially diminish the value of such patent. If we or any of our licensors is forced to grant a license to third parties with
respect to any patents relevant to our business, our competitive position may be impaired.
If we do not obtain patent term extension
in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending
the term of marketing exclusivity for our products, our business may be materially harmed.
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
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 products are obtained, once the patent life has expired for a product, we may be open to competition from competitive medications,
including generic medications. Given the amount of time required for the development, testing and regulatory review of new products,
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 using or commercializing technologies or products
similar or identical to ours.
Depending upon the timing, duration and conditions
of FDA marketing approval of our product candidates, we may be able to extend the term of a patent covering each product candidate under
the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments and similar legislation
in the EU. The Hatch-Waxman Amendments permit a patent term extension of up to five years for a patent covering an approved product as
compensation for effective patent term lost during product development and the FDA regulatory review process. 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 one patent that is
applicable to and covers an approved drug may be extended. Similar provisions are available in Europe, such as supplementary protection
certificates, and in certain other non-United States jurisdictions to extend the term of a patent that covers an approved drug.
However, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant
patents or otherwise fail to satisfy applicable requirements. Moreover, the length of a patent term extension could be less than we request.
If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we
can enforce our patent rights for that product will be shortened and our competitors may obtain approval to market competing products
sooner. As a result, our revenue from applicable products could be reduced, possibly materially.
Further, under certain circumstances, the term
of a patent covering our products may be extended for time spent during the pendency of the corresponding patent application in the USPTO
(referred to as Patent Term Adjustment, or PTA). The laws and regulations underlying how the USPTO calculates the PTA is subject to change
and any such PTA granted by the USPTO could be challenged by a third-party. If we do not prevail under such a challenge, the PTA may
be reduced or eliminated, resulting in a shorter patent term, which may negatively impact our ability to exclude competitors.
Because PTA added to the term of patents covering
pharmaceutical products has particular value, our business may be adversely affected if the PTA is successfully challenged by a third
party and our ability to exclude competitors is reduced or eliminated.
Intellectual property rights do not address
all potential threats to our competitive advantage.
The degree of future protection afforded by our
intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business,
or permit us to maintain our competitive advantage. The following examples are illustrative:
| |
● |
others
may be able to make products that are similar to our Product Candidates or our future products or product candidates but that are
not covered by the claims of the patents that we own or license from others; |
| |
● |
others
may independently develop similar or alternative technologies or otherwise circumvent any of our technologies without infringing
our intellectual property rights; |
| |
● |
we or
any of our collaborators might not have been the first to conceive and reduce to practice the inventions covered by the patents or
patent applications that we own, license or will own or license; |
| |
● |
we or
any of our collaborators might not have been the first to file patent applications covering certain technologies we or they own or
have obtained a license, or will own or obtain a license; |
| |
● |
it is
possible that our owned and in-licensed pending patent applications will not lead to issued patents; |
| |
● |
issued
patents that we own and in-licensed may not provide us with any competitive advantage, or may be held invalid or unenforceable, as
a result of legal challenges by our competitors; |
| |
● |
our competitors
might conduct research and development activities in countries where we do not have patent rights, or in countries where research
and development safe harbor laws exist, and then use the information learned from such activities to develop competitive products
for sale in our major commercial markets; |
| |
● |
ownership
and inventorship of our owned and in-licensed patents or patent applications may be challenged by third parties; and |
| |
● |
patents
of third parties, or pending or future applications of third parties, if issued, may have an adverse effect on our business. |
Our reliance on third parties requires
us to share our trade secrets, which increases the possibility that our trade secrets will be misappropriated or disclosed, and confidentiality
agreements with employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.
We consider proprietary trade secrets or confidential
know-how and unpatented know-how to be important to our business. We may rely on trade secrets or confidential know-how to protect our
technology, especially where patent protection is believed by us to be of limited value. Because we expect to rely on third parties to
manufacture our Product Candidates and any future products and product candidates, and we expect to collaborate with third parties on
the development of our Product Candidates and any future products and product candidates, we must, at times, share trade secrets with
them. We also conduct joint research and development programs that may require us to share trade secrets under the terms of our research
and development partnerships or similar agreements. However, trade secrets or confidential know-how can be difficult to maintain as confidential.
To protect this type of information against disclosure
or appropriation by competitors, our policy is to require our employees, consultants, collaborators, contractors and advisors to enter
into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with
us prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties
to use or disclose our confidential information, including our trade secrets. However, current or former employees, consultants, collaborators,
contractors and advisors may unintentionally or willfully disclose our confidential information to competitors, and confidentiality agreements
may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. The need to share trade secrets
and other confidential information 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. Given that our proprietary position is based,
in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure
would impair our competitive position and may have an adverse effect on our business and results of operations. Enforcing a claim that
a third party obtained illegally and is using trade secrets or confidential know-how is expensive, time consuming and unpredictable.
The enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction.
In addition, these agreements typically restrict
the ability of our employees, consultants, collaborators, contractors and advisors to publish data potentially relating to our trade
secrets, although our agreements may contain certain limited publication rights. Despite our efforts to protect our trade secrets, our
competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publication
of information by any of our third-party collaborators. A competitor’s discovery of our trade secrets would impair our competitive
position and have an adverse impact on our business.
If our trademarks and trade names are not
adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely
affected.
Our unregistered trademarks or trade names may
be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect
our rights to these trademarks and trade names, which we need to build name recognition among potential collaborators or customers in
our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build
brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims
brought by owners of other registered trademarks or trademarks that incorporate variations of our unregistered trademarks or trade names.
Over the long term, if we are unable to successfully register our trademarks and trade names and establish name recognition based on
our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected. Our efforts
to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property
may be ineffective and could result in substantial costs and diversion of resources and could adversely impact our financial condition
or results of operations.
We may need to license certain intellectual
property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
A third party may hold intellectual property,
including patent rights that are important or necessary for the development or commercialization of our Product Candidates or our future
products or product candidates. It may be necessary for us to use the patented or proprietary technology of third parties to commercialize
our Product Candidates, in which case we would be required to obtain a license from these third parties. Such a license may not be available
on commercially reasonable terms, or at all, which could materially harm our business. At this time, we are unaware of any intellectual
property that interferes with ours or is complementary and needed to commercialize our Product Candidates.
We may be subject to claims that our employees,
consultants, collaborators contractors or advisors have wrongfully used or disclosed confidential information of their former employers
or other third parties.
We employ individuals who were previously
employed at other biotechnology or pharmaceutical companies. Although we seek to protect our ownership of intellectual property
rights by ensuring that our agreements with our employees, consultants, collaborators, contractors, advisors and other third parties
with whom we do business include provisions requiring such parties to assign rights in inventions to us, we may be subject to claims
that we or our employees, consultants, collaborators, contractors and advisors have inadvertently or otherwise used or disclosed
confidential information of their former employers or other third parties. We have recently been involved in litigation involving
claims of misappropriation of trade secrets by our former chief executive officer. See “Part 1 Business – Recent
Developments – Litigation,” We may also be subject to claims that the former employers or other third parties have an
ownership interest in our patents. Litigation may be necessary to defend against these claims. There is no guarantee of success in
defending these claims, and if we 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, valuable intellectual property. Even if we are
successful, litigation could result in substantial cost and be a distraction to our management and other employees.
Our proprietary information may be lost,
or we may suffer security breaches.
In the ordinary course of our business, we collect
and store sensitive data, including intellectual property, clinical trial data, proprietary business information, personal data and personally
identifiable information of our clinical trial subjects and employees, in our data centers and on our networks. The secure processing,
maintenance and transmission of this information is critical to our operations. Despite our security measures, our information technology
and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Although,
to our knowledge, we have not experienced any such material security breach to date, any such breach could compromise our networks and
the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information
could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, significant regulatory
penalties, disrupt our operations, damage our reputation and cause a loss of confidence in us and our ability to conduct clinical trials,
which could adversely affect our reputation and delay our clinical development of our product candidates.
Risks Related to Our Employees, Managing Our
Growth and Our Operations
We have experienced turnover in our senior
management team, and the loss of one or more of our executive officers or key employees or an inability to attract and retain highly
skilled employees could adversely affect our business.
We are highly dependent on the development, regulatory,
commercialization and business development expertise of the principal members of our management, scientific and clinical teams. Although
we have employment agreements, offer letters or consulting agreements with our executive officers, these agreements do not prevent them
from terminating their services at any time. We have in the past and may in the future experience changes in our executive management
team resulting from the departure of executives, which may be disruptive to our business.
If we lose one or more of our executive officers
or key employees, our ability to implement our business strategy successfully could be seriously harmed. We have in the past and may
in the future experience changes in our executive management team resulting from the departure of executives, which may be disruptive
to our business. To continue to develop our pipeline and execute our strategy, we must attract and retain highly skilled personnel in
our industry. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because
of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop product
candidates, gain regulatory approval, and commercialize new products. Competition to hire from this limited pool is intense, and we may
be unable to hire, train, retain or motivate these additional key personnel on acceptable terms given the competition among numerous
pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical
personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical
advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be
engaged by entities other than us and may have commitments under consulting or advisory contracts with other entities that may limit
their availability to us. If we are unable to continue to attract and retain highly qualified personnel, our ability to develop and commercialize
product candidates will be limited.
We expect to expand our development, regulatory,
and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our
operations.
We expect to experience significant growth in
the number of our employees and the scope of our operations, particularly in the areas of development, regulatory affairs and sales and
marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial
systems, expand our facilities or acquire new facilities and continue to recruit and train additional qualified personnel. Due to our
limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we
may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion
of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage
growth could delay the execution of our business plans or disrupt our operations.
We may engage in acquisitions that could
disrupt our business, cause dilution to our stockholders or reduce our financial resources.
In the future, we may enter into transactions
to acquire other businesses, products or technologies. If we do identify suitable candidates, we may not be able to make such acquisitions
on favorable terms, or at all. Any acquisitions we make may not strengthen our competitive position, and these transactions may be viewed
negatively by customers or investors. We may decide to incur debt in connection with an acquisition or issue our common stock or other
equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders.
We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we
may obtain from the seller. In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations
into our existing business in an effective, timely and nondisruptive manner. Acquisitions may also divert management attention from day-to-day
responsibilities, increase our expenses and reduce our cash available for operations and other uses. We cannot predict the number, timing
or size of future acquisitions or the effect that any such transactions might have on our operating results.
Our business and operations would suffer
in the event of system failures.
Our computer systems, as well as those of our
CROs and other contractors and consultants, are vulnerable to damage from computer viruses, unauthorized access, natural disasters (including
hurricanes), terrorism, war and telecommunication and electrical failures. If such an event were to occur and cause interruptions in
our operations, it could result in a material disruption of our development programs. For example, the loss of preclinical or clinical
trial data from completed, ongoing or planned trials could result in delays in our regulatory approval efforts and significantly increase
our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage
to our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability
and the further development of our Product Candidates or any other product candidate could be delayed.
We are increasingly dependent on information
technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.
Significant disruptions to our information technology
systems or breaches of information security could adversely affect our business. In the ordinary course of business, we collect, store
and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality
and integrity of such confidential information. The size and complexity of our information technology systems, and those of our third-party
vendors with whom we contract, make such systems potentially vulnerable to service interruptions and security breaches from inadvertent
or intentional actions by our employees, partners or vendors, from attacks by malicious third parties, or from intentional or accidental
physical damage to our systems infrastructure maintained by us or by third parties. Maintaining the secrecy of this confidential, proprietary,
or trade secret information is important to our competitive business position. While we have taken steps to protect such information
and invested in information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches
in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential information that could adversely affect
our business operations or result in the loss, dissemination, or misuse of critical or sensitive information. A breach of our security
measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse of trade secrets, proprietary
information, or other confidential information, whether as a result of theft, hacking, fraud, trickery or other forms of deception, or
for any other reason, could enable others to produce competing products, use our proprietary technology or information, or adversely
affect our business or financial condition. Further, any such interruption, security breach, loss or disclosure of confidential information,
could result in financial, legal, business, and reputational harm to us and could have a material adverse effect on our business, financial
position, results of operations or cash flow.
Risks Related to Our Common Stock
The market price of our common stock has
been volatile and can fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
The market price of our common stock is highly
volatile and for the year ended December 31, 2023, the market price of our common stock has ranged from $2.40 to $12.00 per share, as
adjusted for the 1-10 reverse stock split effected March 1, 2024. The recent fluctuations in our trading price and future trading in our
common stock may be subject to wide fluctuations in response to a variety of factors, including the following:
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any delay
in the commencement, enrollment and ultimate completion of our clinical trials; |
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any delay
in submitting an NDA and any adverse development or perceived adverse development with respect to the FDA’s review of that
NDA; |
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failure
to successfully develop and commercialize our Product Candidates or any future product candidate; |
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results of ongoing litigation as previously described as well as any
new litigation, to which we are party; |
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inability
to obtain additional funding; |
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regulatory
or legal developments in the United States and other countries applicable to our Product Candidates or any other product candidate; |
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adverse
regulatory decisions; |
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changes
in the structure of healthcare payment systems; |
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inability
to obtain adequate product supply for our Product Candidates or any other product candidate, or the inability to do so at acceptable
prices; |
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introduction
of new products, services or technologies by our competitors; |
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failure
to meet or exceed financial projections we provide to the public; |
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failure
to meet or exceed the estimates and projections of the investment community; |
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changes
in the market valuations of companies similar to ours; |
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market
conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports
or recommendations; |
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announcements
of significant acquisitions, strategic collaborations, joint ventures or capital commitments by us or our competitors; |
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significant
lawsuits, including patent or stockholder litigation, and disputes or other developments relating to our proprietary rights, including
patents, litigation matters and our ability to obtain patent protection for our technologies; |
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additions
or departures of key scientific or management personnel; |
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sales
of our common stock by us or our stockholders in the future; |
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trading
volume of our common stock; |
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general
economic, industry and market conditions; |
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health
epidemics and outbreaks, including COVID-19, which could significantly disrupt our preclinical studies and clinical trials, and therefore
our receipt of necessary regulatory approvals could be delayed or prevented; and |
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the other
factors described in this “Risk Factors” section. |
In addition, the stock markets have experienced
extreme price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies.
These fluctuations have often been unrelated or disproportionate to the operating performance of those companies. Broad market and industry
factors, as well as general economic, political, regulatory and market conditions, may negatively affect the market price of our common
stock, regardless of our actual operating performance.
We could be subject to securities class action
litigation.
In the past, securities class action litigation
has often been brought against companies following a decline in the market price of their securities. This risk is especially relevant
for us because biotechnology companies have experienced significant share price volatility in recent years. If we face such litigation,
it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.
If securities or industry analysts do not
publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our common stock, our stock
price and trading volume could decline.
The trading market for our common stock will
depend, in part, on the research and reports that securities or industry analysts may publish about us or our business. We do not have
any control over these analysts. If our financial performance fails to meet analyst estimates or one or more of the analysts who cover
us downgrade our common stock or change their opinion of our common stock, our share price would likely decline. If one or more of these
analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could
cause our share price or trading volume to decline.
Because we do not anticipate paying any
cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
We have never declared or paid any cash dividends
on our common stock. We currently anticipate that we will retain future earnings for the development, operation and expansion of our
business and do not anticipate declaring or paying any cash dividends for the foreseeable future. As a result, capital appreciation,
if any, of our common stock would be your sole source of gain on an investment in our common stock for the foreseeable future. See “Dividend
Policy” for additional information.
We have incurred and will continue to incur
increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance
initiatives and corporate governance practices.
As a public company, and particularly after we
no longer qualify as an emerging growth company, we have incurred and will continue to incur significant legal, accounting and other costs.
The Sarbanes-Oxley Act of 2002 (“SOX”), the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements
of Nasdaq, and other applicable securities rules and regulations impose various requirements on U.S. reporting public companies, including
the establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and
other personnel devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations increase our
legal and financial compliance costs and make some activities more time-consuming and costly. For example, our status as a public company
makes it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial
costs to maintain the level of coverage that we believe is appropriate for a public Company. This could make it more difficult for us
to attract and retain qualified senior management personnel or members for our board of directors (the “Board of Directors”).
In addition, these rules and regulations are often subject to varying interpretations, and, as a result, their application in practice
may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding
compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
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 prepare for eventual compliance with Section 404, once we no longer qualify as an emerging growth company,
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. Despite our efforts, there is a risk that we will not be able to conclude, within
the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404.
If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence
in the reliability of our financial statements.
We are an “emerging growth company,”
and the reduced reporting requirements applicable to emerging growth companies may make our common stock less attractive to investors.
On April 5, 2012, the Jumpstart Our Business
Startups Act of 2012 (“JOBS Act”) was signed into law. The JOBS Act contains provisions that, among other things, reduce
certain reporting requirements for an “emerging growth company”. As an “emerging growth company,” we are electing
to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards,
and as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is
required for non-emerging growth companies. Section 107 of the JOBS Act provides that our decision not to take advantage of the extended
transition period is irrevocable. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,”
we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over
financial reporting pursuant to Section 404, (ii) provide all of the compensation disclosure that may be required of non-emerging growth
public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted
by the Public Company Accounting Oversight Board regarding reporting and critical audit matters, and (iv) disclose certain executive
compensation-related items such as the correlation between executive compensation and performance and comparisons of the chief executive
officer’s compensation to median employee compensation. These exemptions will apply until the last day of the fiscal year including
the fifth anniversary of the completion of our initial public offering or until we no longer meet the requirements for being an “emerging
growth company,” whichever occurs first.
In addition, under the JOBS Act, emerging growth
companies may delay adopting new or revised accounting standards until such time as those standards apply to private companies. Although
we have not done so, we may elect not to avail ourselves of this exemption from new or revised accounting standards and, therefore, may
be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
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 share price may be more volatile.
Anti-takeover provisions contained in our
certificate of incorporation and bylaws, as well as provisions of Delaware law, could impair a takeover attempt.
Our certificate of incorporation, bylaws and
Delaware law contain provisions which could have the effect of rendering more difficult, delaying or preventing an acquisition deemed
undesirable by our Board of Directors. Our corporate governance documents include provisions:
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classifying
our Board of Directors into three classes; |
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authorizing
“blank check” preferred stock, which could be issued by our Board of Directors without stockholder approval and may contain
voting, liquidation, dividend, and other rights superior to our common stock; |
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limiting
the liability of, and providing indemnification to, our directors and officers; |
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limiting
the ability of our stockholders to call and bring business before special meetings; |
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requiring
advance notice of stockholder proposals for business to be conducted at meetings of our stockholders and for nominations of candidates
for election to our Board of Directors; |
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controlling
the procedures for the conduct and scheduling of Board of Directors and stockholder meetings; and |
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providing
our Board of Directors with the express power to postpone previously scheduled annual meetings and to cancel previously scheduled
special meetings. |
These provisions, alone or together, could delay
or prevent hostile takeovers and changes in control or changes in our management.
As a Delaware corporation, we are also subject
to provisions of Delaware law, including Section 203 of the Delaware General Corporation law, which prevents some stockholders holding
more than 15% of our outstanding common stock from engaging in certain business combinations without approval of the holders of substantially
all of our outstanding common stock.
Any provision of our certificate of incorporation,
bylaws or Delaware law that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders
to receive a premium for their shares of our common stock and could also affect the price that some investors are willing to pay for
our common stock.
Our certificate of incorporation, as amended,
designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings
that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for
disputes with us or our directors, officers or other employees.
Our certificate of incorporation requires that,
unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will, to the fullest
extent permitted by law, be the sole and exclusive forum for each of the following:
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any derivative
action or proceeding brought on our behalf; |
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any action
asserting a claim for breach of any fiduciary duty owed by any director, officer or other employee of ours to the Company or our
stockholders, creditors or other constituents; |
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any action
asserting a claim against us or any director or officer of ours arising pursuant to, or a claim against us or any of our directors
or officers, with respect to the interpretation or application of any provision of, the DGCL, our certificate of incorporation or
bylaws; or |
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any action
asserting a claim governed by the internal affairs doctrine; |
provided, that, if and only if the Court of Chancery
of the State of Delaware dismisses any of the foregoing actions for lack of subject matter jurisdiction, any such action or actions may
be brought in another state court sitting in the State of Delaware.
The exclusive forum provision is limited to the
extent permitted by law, and it will not apply to claims arising under the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or for any other federal securities laws which provide for exclusive federal jurisdiction.
Furthermore, Section 22 of the Securities
Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal
courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent
or contrary rulings by different courts, among other considerations, our amended and restated certificate of incorporation provides that
the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a
cause of action arising under the Securities Act. While the Delaware courts have determined that such choice of forum provisions are
facially valid, a stockholder may nevertheless seek to bring such a claim arising under the Securities Act against us, our directors,
officers, or other employees in a venue other than in the federal district courts of the United States of America. In such instance,
we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended and restated certificate
of incorporation.
Our failure to meet the continued listing
requirements of The Nasdaq Capital Market could result in a de-listing of our common stock.
Our shares of common stock are listed for trading
on The Nasdaq Capital Market under the symbol “VRPX.” If we fail to satisfy the continued listing requirements of The Nasdaq
Capital Market such as the corporate governance requirements, the stockholder’s equity requirement or the minimum closing bid price
requirement, The Nasdaq Capital Market may take steps to de-list our common stock or warrants.
On April 10, 2023, we received a written notice (the “Notice”)
from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) indicating that we are not in compliance
with the $1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market
(the “Bid Price Requirement”). On February 29, 2024, we filed a Certificate of Amendment
to the Amended and Restated Certificate of Incorporation (the “Amendment”) with the Secretary of State of the State of Delaware
to effect a 1-for-10 reverse stock split, which was effective on March 1, 2024. Although, we have regained compliance with the
$1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) by effecting a reverse stock split there can be no assurance
that we will continue to maintain compliance with the Nasdaq continued listing requirements. Any perception that we may not regain compliance
for future noncompliance or a delisting of our common stock by Nasdaq could adversely affect our ability to attract new investors, decrease
the liquidity of the outstanding shares of our common stock, reduce the price at which such shares trade and increase the transaction
costs inherent in trading such shares with overall negative effects for our stockholder. In addition, delisting of our common stock from
Nasdaq could deter broker-dealers from making a market in or otherwise seeking or generating interest in our common stock and might deter
certain institutions and persons from investing in our common stock.
In the event of a de-listing, we would take actions
to restore our compliance with The Nasdaq Capital Market’s listing requirements, but we can provide no assurance that any such
action taken by us would allow our common stock become listed again, stabilize the market price or improve the liquidity of our common
stock, prevent our common stock from dropping below The Nasdaq Capital Market, minimum bid price requirement or prevent future non-compliance
with The Nasdaq Capital Market’s listing requirements.
The National Securities Markets Improvement Act
of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred
to as “covered securities.” Because our common stock is listed on The Nasdaq Capital Market, our common stock is covered
securities. Although the states are preempted from regulating the sale of covered securities, the federal statute does allow the states
to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate
or bar the sale of covered securities in a particular case. Further, if we were to be delisted from The Nasdaq Capital Market, our common
stock would cease to be recognized as covered securities and we would be subject to regulation in each state in which we offer our securities.
Although we believe this provision benefits us
by providing increased consistency in the application of Delaware law in the types of lawsuits to which it applies, this provision may
limit or discourage a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or
our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees.
Alternatively, if a court were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable
or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could
adversely affect our business and financial condition.
We note that there is uncertainty as to whether
a court would enforce the provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations
thereunder. Although we believe this provision benefits us by providing increased consistency in the application of Delaware law in the
types of lawsuits to which it applies, the provision may have the effect of discouraging lawsuits against our directors and officers.
ITEM 1B. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 1C. CYBERSECURITY
Risk Management and Strategy
We are a pre-clinical-stage biopharmaceutical
company, focused on developing novel and proprietary drug delivery systems across various pain indications and treatments for CNS disorders.
We have conducted a cyber security risk assessment performed by a third-party consultant and are in the process of developing a formal
cybersecurity risk management program designed to identify, assess, manage, mitigate, and respond to cybersecurity threats. The risk assessment
was performed against the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework (“CSF”)
standards.
We have implemented third-party risk management
processes to manage the risks associated with reliance on vendors, critical service providers, and other third-parties that may lead to
a service disruption or an adverse cybersecurity incident. This includes an assessment of vendors during the selection/onboarding process
and a review of SOC 1 reports on an annual basis.
In addition, we maintain policies over areas such as information security,
access on/offboarding, and access and account management, to help govern the processes put in place by management designed to protect
our IT assets, data, and services from threats and vulnerabilities. We partner with industry recognized IT providers leveraging third-party
technology and expertise. These third-party service providers are a key part of our current cybersecurity risk management and provide
services including, maintenance of an IT assets inventory, periodic vulnerability scanning, identity access management controls including
restricted access of privileged accounts, network integrity safeguarded by employing web-based software, including endpoint protection,
endpoint detection and response, and remote monitoring management on all devices, industry-standard encryption protocols and critical
data backups. Our outsourced information technology consultant conducts proactive patching and monitoring of all of our existing systems
and has implemented systems and procedures to mitigate cybersecurity risks that we believe are appropriate for a company of our size,
stage of growth and financial condition. In addition, we carry insurance with coverage for cyber events that we believe is suitable for
a company of our size, stage of growth and financial condition.
As of the date of this Annual Report on Form 10-K, we are not aware
of any cybersecurity threats, and have not experienced any cybersecurity incidents, that have materially affected us, including our business
strategy, results of operations or financial condition.
For additional information concerning risks related to cybersecurity,
see Item lA. Risk Factors: We are increasingly dependent on information technology, and our systems and infrastructure face
certain risks, including cybersecurity and data leakage risks.
Governance
Management is responsible for the day-to-day management of the risks
we face, while our Board of Directors has responsibility for the oversight of risk management, including as to risks from cybersecurity
threats. In its risk oversight role, our Board of Directors has the responsibility to satisfy itself that the risk management processes
designed and implemented by management are appropriate and functioning as designed. The Board of Directors has delegated to the Audit
Committee of the Board of Directors the responsibility for the oversight of information technology, including cybersecurity risks. Member(s)
of management assigned with cybersecurity oversight responsibility and/or third-party consultants providing cyber risk services brief
the Audit Committee on cyber vulnerabilities identified through the risk management process, emerging threat landscape and new cyber risks,
and provide updates on our processes to prevent, detect, and mitigate cybersecurity incidents.
ITEM 2. PROPERTIES
Our principal address is 1055 Westlakes Drive,
Suite 300, Berwyn, PA 19312. We believe our facilities are adequate to meet our current needs, although we may seek to negotiate new
leases or evaluate additional or alternate space for our operations. We believe appropriate alternative space would be readily available
on commercially reasonable terms.
ITEM 3. LEGAL PROCEEDINGS
On March 12, 2021, the Company and its former
Chief Executive Officer, Anthony P. Mack (together, the “Defendants”), were named as defendants in a complaint (the “Complaint”)
filed by Sorrento Therapeutics, Inc. (“Sorrento”), and Scilex Pharmaceuticals Inc. (“Scilex” and together with
Sorrento, the “Plaintiffs”) in the Court of Chancery of the State of Delaware captioned Sorrento Therapeutics, Inc. and
Scilex Pharmaceuticals Inc. v. Anthony Mack and Virpax Pharmaceuticals, Inc., Case No. 2021-0210-PAF (the “Action”).
In the Complaint, Plaintiffs alleged (i) Mr. Mack breached a Restrictive Covenants Agreement, dated as of November 8, 2016, between himself
and Sorrento (the “Restrictive Covenants Agreement”), (ii) the Company tortiously interfered with the Restrictive Covenants
Agreement, and (iii) the Company tortiously interfered with Scilex’s relationship with Mr. Mack. On May 7, 2021, Plaintiffs filed
an Amended Complaint asserting the same three causes of action. On September 28, 2021, Plaintiffs filed a Second Amended Complaint asserting
the same three causes of action as the prior complaints, as well as claims in which Plaintiffs alleged (i) Mr. Mack breached an Employment,
Proprietary Information and Inventions Agreement, dated as of October 25, 2016, between himself and Sorrento (the “Employment Agreement”),
(ii) the Company tortiously interfered with the Employment Agreement, (iii) Mr. Mack breached his fiduciary duties to Scilex, and (iv)
the Company aided and abetted Mr. Mack’s alleged breach of fiduciary duties to Scilex. On April 1, 2022, Plaintiffs filed a Third
Amended Complaint. The Third Amended Complaint asserts the same causes of action as the Second Amended Complaint, as well as claims for
(i) misappropriation of trade secrets by Defendants under Delaware law, and (ii) misappropriation of trade secrets by Defendants under
California law. On April 18, 2022, Defendants filed answers to the Third Amended Complaint. Trial was held before Vice Chancellor Paul
Fiorvanti from September 12 through September 14, 2022.
In March 2023, the Company collected $1,250,000
in reimbursement of legal costs pursuant to the Company’s directors’ and officers’ insurance policy, and recorded it
as a reduction of general and administrative expense on the consolidated statements of operations. No further reimbursements are permitted
from the insurance policy with respect to the litigation.
On September 1, 2023, the Chancery Court issued
a memorandum opinion addressing liability in the Action and found in favor of Plaintiffs on all but three counts, which the Court found
were waived. The Chancery Court found it proper to attribute Mr. Mack’s knowledge and actions to the Company, which Mr. Mack used
to effectuate the tortious interference and breach of fiduciary duty. The Chancery Court found that Mr. Mack breached the Restrictive
Covenants Agreement he entered into with Sorrento by developing EpoladermTM; the Company is liable for tortious interference
with contract; Plaintiffs were deemed to have waived their claims for breach of Mr. Mack’s Employment Agreement and for tortious
interference with prospective economic advantage; Mr. Mack breached his fiduciary duty of loyalty to Scilex; the Company aided and abetted
Mr. Mack’s breach of fiduciary duty; and Mr. Mack misappropriated certain Scilex trade secrets. The Court, however, stated that
the question of an appropriate remedy must await further briefing.
On October 18, 2023, in accordance with the Chancery
Court’s supplemental briefing schedule, Plaintiffs filed their supplemental brief requesting the following relief: an injunction,
in the first instance, enjoining Mr. Mack from having any relationship with Virpax for a period of 18 months and 27 days; enjoining Virpax
from further developing or marketing Epoladerm for a period of 18 months and 27 days; alternatively, if these two injunction requests
were not granted, Plaintiffs requested a judgement of joint and several liability against Mr. Mack and Virpax of $14,684,833. In addition
to these requests for injunctive relief (or in, the alternative, damages), Plaintiffs sought a constructive trust over the revenues of
Epoladerm, ProbudurTM and EnveltaTM, or, in the alternative to a constructive trust, a royalty of 5 per cent of
net sales of Epoladerm, 8-11 percent of net sales of Probudur and 7.5 percent of net sales of Envelta. In addition to the requests for
injunctive relief, imposition of a constructive trust and/or royalties, Plaintiffs also requested additional damages, jointly and severally,
against Mr. Mack and Virpax as follows: $1.3 million for misuse of Scilex resources, $6.7 million for misappropriation of trade secrets,
$13.4 million for exemplary damage (trade secrets damage x2) and attorney’s fees in an unspecified amount. Finally, Plaintiffs
sought injunctive relief, enjoining Mr. Mack and Virpax from further accessing Scilex’s trade secrets; requiring Mr. Mack and Virpax
to return Scilex’s trade secrets to Plaintiffs; and enjoining Mr. Mack and Virpax from marketing or selling any products derived
from or incorporating Scilex’s trade secrets.
On November 29, 2023, in accordance with the
Chancery Court’s supplemental briefing schedule, Defendants filed their supplement brief on damages rebutting Plaintiffs’
damages analysis. Throughout the brief, Defendants argued Plaintiffs failed to meet their burden to prove damages, and as such, should
be precluded from any damages award. However, given the Court’s instruction, Defendants proffered a reasonable damages analysis
as follows. As for the injunctive relief requested against Mr. Mack, the Company took no position, as the request was directed to Mr.
Mack personally. Concerning Plaintiffs’ request for an injunction against further development of Epoladerm for a period of 18 months
and 27 days, Defendants opposed this request, arguing lack of irreparable harm, given Plaintiffs’ request for money damages. Defendants
also argued a constructive trust is inappropriate, given Plaintiffs failed to articulate the parameters of such relief and, additionally,
the lack of sales for the drug candidates preclude such relief. In terms of the money damages related to the three drug candidates, Defendants
proffered a reasonable royalty rate of 1-3% of the net profits of the drug candidates, as opposed to lump sum damages, as such rate would
alleviate the speculative nature of the damages requested by Plaintiffs. As for the misappropriation of trade secrets request of $6.7
million, given the Court found only 5 of the proffered 1,182 documents were trade secrets, Defendants contend Plaintiffs should receive
no monetary damages (given the reasonable royalty would encompass use of these documents and, alternatively, Defendants would return
such documents). However, if the Court were to award damages, such damages should be pro rata for the documents, or roughly $28,382.
And, finally, Defendants opposed the request for attorneys’ fees and exemplary damages.
On December 21, 2023, Plaintiffs filed their
reply brief on damages, generally reasserting their prior arguments on damages and rebutting Defendants’ arguments. Plaintiffs
also asserted they supported their damages claims with sufficient evidence.
On February 29, 2024, Plaintiffs and the Company
entered into a Settlement Agreement to fully resolve all issues related to settlement of the litigation with Plaintiffs, subject to the
entry by the United States Bankruptcy Court for the Southern District of Texas, which is handling the Sorrento bankruptcy filing, of an
order approving the Settlement Agreement. On March 1, 2024, the Plaintiffs filed a motion to approve the Settlement Agreement and grant
the related relief with the Bankruptcy Court. On March 14, 2024, the Bankruptcy Court entered an order approving the Settlement Agreement
and on March 20th the Plaintiffs filed a Stipulation of Dismissal with the Chancery Court dismissing the Action.
As settlement consideration, the Company agreed
to pay Sorrento and Scilex a total cash payment of $6 million, of which $3.5 million was paid on March 18, 2024, two business days after
the Effective Date, and the remaining $2.5 million is to be paid on or before July 1, 2024. Additionally, the Company agreed to pay to
Plaintiffs royalties of 6% of annual net sales of products developed from drug candidates Epoladerm, Probudur and Envelta until the earlier
of the expiration of the last-to-expire valid patent claim of such product and the expiration of any period of regulatory exclusivity
for such product.
Pursuant to the Settlement Agreement, each of
the Plaintiffs and the Company provided mutual releases of all claims as of the Effective Date, whether known or unknown, arising from
any allegations set forth in the Action. Plaintiffs’ release relates to claims against the Company only. Plaintiffs’ release
as to the Company was effective upon the Company’s initial payment of $3.5 million, and the Company’s release of the Plaintiffs
was effective upon the Effective Date.
The Plaintiffs can still pursue claims
against Mr. Mack. The Company’s Bylaws require the Company to “indemnify any person who was or is a party or is
threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal,
administrative or investigative (other than an action by or in the right of the Corporation) by reason of the fact that such person
is or was a director or officer of the Corporation, or, while a director or officer of the Corporation….” Such
indemnification, however, is limited to circumstances where the covered person “acted in good faith and in a manner such
person reasonably believed to be in or not opposed to the best interests of the Corporation….” Mr. Mack may
attempt to claim he is entitled to indemnification, should the Court find him liable for damages in the Action. Given the
findings in the Memorandum Opinion issued in the Action, the Company believes it has a strong position that Mr. Mack would not be
entitled to indemnification. There is a risk, however, that a Court could find he is entitled to such indemnification.
Additionally, per Section 7.6 of the Bylaws, the Company has been advancing Mr. Mack’s attorneys’ fees and costs for the
Action. It is likely Mr. Mack will contend he is still entitled to advancement of any fees and/or costs for the Action going
forward and may seek judicial intervention. However, as per the Bylaws, Mr. Mack is only entitled to advancement of expenses for
indemnifiable actions. As noted above, given the Memorandum Opinion in the Action, the Company believes that it has a
strong position that Mr. Mack is not entitled to indemnification, and therefore, not entitled to advancement of expenses. However,
there is a risk that a Court could find that Mr. Mack is entitled to such advancement. Further, Mr. Mack may attempt to seek
damages from the Company based on the Court’s final judgment on damages under the theory of joint and several liability and
seek contribution from the Company for any monetary judgment. (See Item 1-Business and Item 1A-Risk Factors)
The Court is aware that Plaintiffs have settled
with the Company and that the Settlement Agreement fully releases the Company from any claims or damages, the Plaintiff has against the
Company, related to the Action. Given the Settlement Agreement does not release Mr. Mack from liability related to the Action, the Court
has requested supplemental briefing as to whether the Court can dismiss the Company from the lawsuit, as well as any claims Mr. Mack has
against the Company arising from the Action. While the Company believes that any damages assessed may be awarded against Mr. Mack alone,
Plaintiffs cannot seek additional damages from Virpax. However, there is a risk that Mr. Mack will still seek contribution from the Company
for any damages claim arising from the Action. And, there is a risk that the Court will rule in Mr. Mack’s favor.
No further reimbursements are permitted from our
insurance policy with respect to the litigation. Accordingly, if Mr. Mack was successful in seeking indemnification from us, we would
have to pay such amounts in cash which would further reduce our cash position.
From time to time we are subject to claims by
third parties under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have
a material adverse effect on our liquidity, financial condition and cash flows.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON
EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Our Common Stock trades
on Nasdaq under the symbol “VRPX” and began trading on February 17, 2021. Prior to that date, there was no public market for
our stock. The last reported sale price of our common stock on Nasdaq on March 22, 2024 was $4.03 per share of common stock.
Holders
As of March 22, 2024, there were approximately
38 holders of record of our Common Stock. This number does not include beneficial owners whose shares are held in street name. The actual
number of holders of our Common Stock is greater than this number of record holders and includes stockholders who are beneficial owners,
but whose shares are held in street name by brokers or held by other nominees.
Dividends
We have never declared or paid cash dividends
on our Common Stock. We do not intend to declare or pay cash dividends on our common stock for the foreseeable future, but currently
intend to retain any future earnings to fund the development and growth of our business. The payment of cash dividends if any, on the
common stock will rest solely within the discretion of our Board of Directors and will depend, among other things, upon our earnings,
capital requirements, financial condition, and other relevant factors.
Recent Sales of Unregistered Securities
None.
Issuer Purchases
of Equity Securities
None.
Equity Compensation Plan Information
The following table provides information with
respect to our compensation plans under which equity compensation was authorized as of December 31, 2023.
| | |
Number of
securities
to be
issued
upon
exercise of
outstanding
options,
warrants
and rights | | |
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) | |
| Plan category | |
(a) | | |
(b) | | |
(c) | |
| Equity compensation plans approved by security holders(1) | |
| 175,686 | (2) | |
$ | 34.60 | | |
| 116,511 | (3)(4) |
| Equity compensation plans not approved by security holders | |
| - | | |
| - | | |
| - | |
| Total | |
| 175,686 | | |
$ | 34.60 | | |
| 116,511 | |
| (1) |
The
amounts shown in this row include securities under the 2017 Plan and the 2022 Plan. |
| (2) |
Includes
98,886 and 76,800 shares of common stock issuable upon exercise of outstanding options pursuant to the 2017 Plan and the
2022 Plan, respectively, as of December 31, 2023. |
| (3) |
In
accordance with the “evergreen” provision in the 2022 Plan, an additional 23,428 shares were automatically made available
for issuance on the first day of 2023, which represents 2% of the number of shares outstanding on December 31, 2023; these shares
are excluded from this calculation. |
| (4) |
Includes
0 and 116,511 shares of common stock available for issuance under the 2017 Plan and the 2022 Plan, respectively, as of December
31, 2023. |
ITEM 6. [RESERVED]
Not applicable.
ITEM 7. MANAGEMENT’S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and
analysis of our financial condition and results of operations together with our financial statements and the related notes appearing
at the end of this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere
in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business and related financing,
includes forward-looking statements that involve risks and uncertainties. You should read “Cautionary Note Regarding Forward-Looking
Statements” and Item 1A. Risk Factors of this Annual Report on Form 10-K for a discussion of important factors that could
cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the
following discussion and analysis.
Overview
Company Overview
We are a preclinical-stage pharmaceutical company
focused on developing novel and proprietary drug delivery systems across various pain indications in order to enhance compliance and
optimize each product candidate in our pipeline. Our drug-delivery systems, and drug-releasing technologies being developed are focused
on advancing non-opioid and non-addictive pain management treatments and treatments for central nervous system (“CNS”) disorders
to enhance patients’ quality of life.
We have exclusive global rights to the following proprietary patented
technologies: (i) Molecular Envelope Technology (“MET”) that uses an intranasal device to deliver enkephalin to control severe
pain, including post cancer pain (Envelta™) and PTSD, (ii) Injectable “local anesthetic” Liposomal Technology for postoperative
pain management (Probudur™), and (iii) Investigational formulation delivered via the nasal route to enhance pharmaceutical-grade
cannabidiol (“CBD”) transport to the brain (“NobrXiol™”, formerly VRP324) to potentially treat epileptic
seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in pediatric patients two years of age and older. We are also exploring
value creative opportunities for our two nonprescription product candidates including seeking regulatory approval for commercialization
of such products: AnQlar, which is being developed as a 24 hour prophylactic viral barrier to inhibit viral infection by influenza or
SARS-CoV-2, and Epoladerm™, which is a topical diclofenac epolamine metered dosed spray film formulation being developed to manage
pain associated with osteoarthritis.
Critical Accounting Estimates
We have based our management’s discussion
and analysis of financial condition and results of operations on our financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make
estimates that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date
of the financial statements as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate
our estimates and judgments, including those related to clinical development expenses and stock-based compensation. We base our estimates
on historical experience and on various other factors that we believe to be appropriate under the circumstances. Actual results may differ
from these estimates under different assumptions or conditions.
While our significant accounting policies are
more fully discussed in Note 2 to our audited financial statements contained within this Annual Report on Form 10-K, we believe that
the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our
financial statements.
Research and Development Expenses
We rely on third parties to conduct our preclinical
studies and to provide services, including data management, statistical analysis and electronic compilation. We have initiated preclinical
trials and at the end of each reporting period, we compare the payments made to each service provider to the estimated progress towards
completion of the related project. Factors that we consider in preparing these estimates include the status of preclinical studies, milestones
achieved and other criteria related to the efforts of our vendors. These estimates are subject to change as additional information becomes
available. Depending on the timing of payments to vendors and estimated services provided, we record net prepaid or accrued expenses
related to these costs.
Stock-Based Compensation
Stock-based compensation cost is measured at
the grant date based on the fair value of the award and is recognized as expense over the requisite service period, which is generally
the vesting period. Our policy permits the valuation of stock-based awards granted to non-employees to be measured at fair value at the
grant date.
Determining the appropriate fair value of share-based awards requires
the use of subjective assumptions, including the fair value of our common shares prior to becoming a public company, and for options,
the expected life of the option and expected share price volatility. We use the Black-Scholes option pricing model to value its option
awards. The assumptions used in calculating the fair value of share-based awards represent management’s best estimates and involve
inherent uncertainties and the application of management’s judgment. As a result, if factors change and management uses different
assumptions, share-based compensation expense could be materially different for future awards. See Note 7 to notes to the consolidated
financial statements contained herein.
Legal and Other Contingencies
The outcomes of legal proceedings and claims
brought against us and other loss contingencies are subject to significant uncertainty. We accrue a charge against income when our management
determines that it is probable that an asset has been impaired, or a liability has been incurred and the amount of loss can be reasonably
estimated. In determining the appropriate accounting for loss contingencies, we consider the likelihood of loss or impairment of an asset
or the incurrence of a liability, as well as our ability to reasonably estimate the amount of loss. We regularly evaluate current information
available to us to determine whether an accrual should be established or adjusted. Estimating the probability that a loss will occur
and estimating the amount of a loss or a range of loss involves significant judgment. As noted in Note 5 Commitments and Contingencies,
the Company has recently settled litigation with the Plaintiffs and entered into a Settlement Agreement. As of December 31, 2022, the
Company had accrued $2.0 million with respect to the litigation. Based on the facts of the litigation and the Settlement Agreement that
was executed, the Company has recognized an accrual totaling $6.0 million with respect to the litigation as of December 31, 2023. The
Company recognized $4.0 million and $2.0 million for the years ended December 31, 2023 and 2022, respectively, included in general and
administrative expenses on the consolidated statements of operations. We have also accrued an estimated $711,000 for payments to be made
to our former Chief Executive Officer with respect to his separation from employment with us. While
the Company believes this estimated expense related to the separation agreement to be reasonably possible, actual results may materially
vary from these estimates. As part of the consideration for the separation agreement, Mr. Mack will be expected to release, discharge
and waive any rights to indemnification, and/or contribution related to the Action. The accrual
does not include any amounts that we may be required to pay for indemnification claims or contribution that he may seek against us.
Results of Operations
Years Ended December 31, 2023 and 2022
Operating expenses:
| | |
Year Ended December 31, | | |
Change | |
| | |
2023 | | |
2022 | | |
Dollars | | |
Percentage | |
| Operating expenses: | |
| | |
| | |
| | |
| |
| General and administrative | |
$ | 10,572,181 | | |
$ | 11,082,463 | | |
$ | (510,282 | ) | |
| (5 | )% |
| Research and development | |
| 5,117,608 | | |
| 10,762,670 | | |
| (5,645,062 | ) | |
| (52 | )% |
| Total operating expenses | |
$ | 15,689,789 | | |
$ | 21,845,133 | | |
$ | (6,155,344 | ) | |
| (28 | )% |
General and administrative expenses decreased
by $510,282, or 5%, to $10,572,181 for the year ended December 31, 2023 from $11,082,463 for the year ended December 31, 2022. This decrease
was a result of a significant decrease of legal defense costs of $2.3 million with regard to litigation, including reimbursement of legal
defense costs of $1.25 million in 2023 pursuant to our directors’ and officers’ insurance policy, and an increase of $2 million
in estimated litigation settlement expense ($2 million in 2022 and $4 million in 2023); and partially offset by an increase of $1.8 million
related to salaries and wages, severance and professional fees.
Research and development expenses decreased by
$5,645,062, or 52%, to $5,117,608 for the year ended December 31, 2023, from $10,762,670 for the year ended December 31, 2022. The decrease
was primarily attributable (i) a one-time milestone payment of $1.5 million made to Nanomerics in 2022 related to expanding AnQlar’s
territory to global rights and a decrease in AnQlar preclinical activities of approximately $3.8 million, (ii) a decrease in preclinical
activities related to Epoladerm, and (iii) a decrease in preclinical activities related to NobrXiol. This was offset by an increase of
approximately $1.3 million related to Probudur preclinical activities, which is our lead asset.
The following table presents R&D expenses
tracked on a program-by-program basis for the year ended December 31, 2023 and 2022.
| | |
Year Ended December 31, | |
| | |
2023 | | |
2022 | |
| Program expenses: | |
| | |
| |
| Envelta | |
$ | 268,868 | | |
$ | 286,793 | |
| Probudur | |
| 2,872,819 | | |
| 1,583,093 | |
| Epoladerm | |
| 714,471 | | |
| 1,830,689 | |
| AnQlar | |
| 836,629 | | |
| 6,115,916 | |
| NobrXiol | |
| 215,415 | | |
| 799,800 | |
| Total program expenses | |
| 4,908,202 | | |
| 10,616,291 | |
| Unallocated expenses: | |
| | | |
| | |
| Stock based compensation | |
| 209,406 | | |
| 146,379 | |
| Total other research and development expense | |
| 209,406 | | |
| 146,379 | |
| Total research and development expenses | |
$ | 5,117,608 | | |
$ | 10,762,670 | |
Other expenses:
| | |
Year Ended December 31, | | |
Change | |
| | |
2023 | | |
2022 | | |
Dollars | | |
Percentage | |
| Other income: | |
| | |
| | |
| |
| Other income | |
$ | 500,281 | | |
$ | 194,413 | | |
$ | 305,868 | | |
| 157 | % |
| Total other income: | |
$ | 500,281 | | |
$ | 194,413 | | |
$ | 305,868 | | |
| 157 | % |
Other income increased by $305,868 primarily
due to interest income.
Liquidity and Capital Resources
Years Ended December 31, 2023 and 2022
Capital Resources
| | |
As of December 31, | | |
Change | |
| | |
2023 | | |
2022 | | |
Dollars | | |
Percentage | |
| Current assets | |
$ | 9,628,345 | | |
$ | 19,673,649 | | |
| (10,045,304 | ) | |
| (51 | )% |
| Current liabilities | |
$ | 7,694,024 | | |
$ | 3,094,590 | | |
| 4,599,434 | | |
| 149 | % |
| Working capital | |
$ | 1,934,321 | | |
$ | 16,579,059 | | |
| (14,644,738 | ) | |
| (88 | )% |
As
of December 31, 2023, our principal source of liquidity was our cash, which totaled approximately $9.1 million. On March 18, 2024, we
paid $3.5 million to the Plaintiffs pursuant to the terms of the Settlement Agreement and we are obligated to pay an additional $2.5 million
to the Plaintiffs on July 1, 2024. We will need to raise additional capital to fund operations and make the $2.5 million payment. We accrued
$0.7 million for estimated payments to be made to our former Chief Executive Officer with respect
to his separation from employment with us, which does not include accrual for any potential indemnification or contribution claims that
he may seek from us that are related to the Action. We
have not generated revenues and have not yet achieved profitable operations, nor have we ever generated positive cash flow from operations.
There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. We are subject to those risks
associated with any preclinical stage pharmaceutical company that has substantial expenditures for research and development. There can
be no assurance that our research and development projects will be successful, that products developed will obtain necessary regulatory
approval, or that any approved product will be commercially viable.
To continue to grow
our business over the longer term, we plan to commit substantial resources to research and development, pre-clinical and clinical trials
of our product candidates, other operations and potential product acquisitions and in-licensing.
We continue to explore opportunities to acquire
or in-license and develop additional products and product candidates to augment our internal development pipeline. Strategic transaction
opportunities that we may pursue could materially affect our liquidity and capital resources and may require us to incur additional indebtedness,
seek equity capital or both. In addition, we may pursue development, acquisition or in-licensing of approved or development products
in new or existing therapeutic areas or continue the expansion of our existing operations. Accordingly, we expect to continue to opportunistically
seek access to additional capital to license or acquire additional products, product candidates or companies to expand our operations,
or for general corporate purposes. Strategic transactions may require us to raise additional capital through one or more public or private
debt or equity financings or could be structured as a collaboration or partnering arrangement. Any equity financing would be dilutive
to our stockholders. We have no arrangements, agreements, or understandings in place at the present time to enter into any acquisition,
in-licensing or similar strategic business transaction.
Cash Flows
Years Ended December 31, 2023 and 2022
The following table summarizes our cash flows
from operating activities:
| | |
For the Year Ended December 31, | |
| | |
2023 | | |
2022 | |
| Statement of cash flow data: | |
| | |
| |
| Net cash used in operating activities | |
$ | (9,853,772 | ) | |
$ | (17,846,708 | ) |
| Net change in cash | |
$ | (9,853,772 | ) | |
$ | (17,846,708 | ) |
Operating Activities
For the year ended December 31, 2023, cash used
in operations was $9,853,772 compared to $17,846,708 for the year ended December 31, 2022. The decrease in cash used in operations was
primarily the result of the decrease in net loss primarily attributable to the decrease in research and development expenses and an increase
in accounts payable and accrued expense, offset by a smaller decrease in prepaid insurance other current assets. In March 2023, we collected
$1,250,000 in reimbursement of legal costs pursuant to our directors’ and officers’ insurance policy, which decreased our
net loss during the period. No further reimbursements are permitted from the insurance policy with respect to the litigation.
Future Capital Requirements
It is difficult to predict our spending for our
product candidates prior to obtaining FDA approval. Moreover, changing circumstances may cause us to expend cash significantly faster
than we currently anticipate, and we may need to spend more cash than currently expected because of circumstances beyond our control.
We have no current understandings, agreements
or commitments for any material acquisitions or licenses of any products, businesses or technologies. We will most likely need to raise
substantial additional capital in order to engage in any of these types of transactions.
We expect to continue to incur substantial additional
operating losses for at least the next several years as we continue to develop our product candidates and seek marketing approval and,
subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for our
product candidates, we will incur significant sales, marketing and outsourced manufacturing expenses. In addition, we expect to incur
additional expenses to add operational, financial and information systems and personnel, including personnel to support our planned product
commercialization efforts. We also expect to continue to incur significant costs to comply with corporate governance, internal controls
and similar requirements applicable to us as a public company.
Our future use of operating cash and capital
requirements will depend on many forward-looking factors, including the following:
| ● | the requirement to fund the remaining portion of $2.5 million
pursuant to the Settlement Agreement as well as the ultimate resolution of any potential litigation with our former Chief Executive Officer
(See “Legal and Other Contingencies” and “Liquidity and Capital Resources” above); |
| ● | initiation,
progress, timing, costs and results of clinical trials for our product candidates; |
| |
● |
the clinical development
plans we establish for each product candidate; |
| |
● |
the number and characteristics
of product candidates that we develop or may in-license; |
| |
● |
the terms of any collaboration
agreements we may choose to execute; |
| |
● |
the outcome, timing and
cost of meeting regulatory requirements established by the U.S. Drug Enforcement Administration, the FDA, the European Medicines
Agency or other comparable foreign regulatory authorities; |
| |
● |
the cost of filing, prosecuting,
defending and enforcing our patent claims and other intellectual property rights; |
| |
● |
the cost of defending intellectual
property disputes, including patent infringement actions brought by third parties against us; |
| |
● |
costs and timing of the
implementation of commercial scale manufacturing activities; and |
| |
● |
the cost of establishing,
or outsourcing, sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval
in regions where we choose to commercialize our products on our own. |
Our capital resources are currently insufficient
to meet our future operating and capital requirements, and therefore we must finance our cash needs through public or private equity
offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. We have no committed external sources
of funds. Additional equity or debt financing or collaboration and licensing arrangements may not be available on acceptable terms, if
at all.
If we raise additional funds by issuing equity
securities, our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations
and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional
debt, making capital expenditures or declaring dividends. Any debt financing or additional equity that we raise may contain terms, such
as liquidation and other preferences that are not favorable to us or our stockholders. If we raise additional funds through collaboration
and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies, future revenue
streams or product candidates or to grant licenses on terms that may not be favorable to us.
Liquidity
Since inception, we have been engaged in organizational
activities, including raising capital and research and development activities. We have not generated revenues and have not yet achieved
profitable operations, nor have we ever generated positive cash flow from operations. There is no assurance that profitable operations,
if achieved, could be sustained on a continuing basis. We are subject to those risks associated with any preclinical stage pharmaceutical
company that has substantial expenditures for research and development. There can be no assurance that our research and development projects
will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially
viable. In addition, we operate in an environment of rapid technological change and is largely dependent on the services of its employees
and consultants. Further, our future operations are dependent on the success of our efforts to raise additional capital.
We incurred a net loss of $15.2 million and $21.7
million for the years ended December 31, 2023 and 2022, respectively, and had an accumulated deficit of $59.5 million as of December 31,
2023. We anticipate incurring additional losses until such time, if ever, that we can generate significant revenue from our product candidates
currently in development. Our primary source of capital has been from the $15.8 million that we raised from the issuance of securities
in our initial public offering that closed in February 2021 and the $37.0 million that we raised from the issuance of securities in a
follow on offering that closed in September 2021.
At December 31, 2023,
we had cash of approximately $9.1 million, on March 22, 2024, we had cash of approximately $2.5 million. We have paid the Plaintiff $3.5
million on March 18, 2024 pursuant to the terms of the Settlement Agreement, and are obligated to pay an additional $2.5 million on or
before July 1, 2024. We accrued $0.7 million for estimated payments to be made to our former Chief
Executive Officer with respect to his separation from employment with us. The accrual does not include any amounts that we may be required
to pay for indemnification claims or contribution that he may seek against us. We will need to raise additional capital to fund
operations and make the $2.5 million payment. Due to our continuing losses and our cash position, there exists substantial doubt about
our ability to continue as a going concern. Our Auditor’s report contains an emphasis of matter regarding our substantial doubt
of continuing as a going concern. The accompanying financial statements do not include any adjustments to the carrying amounts and classification
of assets, liabilities, and reported expenses that may be necessary if we were unable to continue as a going concern.
Our future operations
are dependent on the success of our efforts to raise additional capital. We currently do not have sufficient capital to fund the commercialization
of any of our product candidates. Additional financing will be needed by us to fund our operations, including making payment pursuant
to the Settlement Agreement, and to complete clinical development of and to commercially develop our product candidates. There is no assurance
that such financing will be available when needed or on acceptable terms. Our ability to raise capital to date has been impacted by the
uncertainty of the amount of damages we may be required to pay and it is likely that we will be unable to raise capital, if at all, until
all uncertainties are resolved. Further, our ability to raise additional capital may be adversely impacted by potential worsening of global
economic conditions, potential future global pandemics or health crises, and the recent disruptions to, and volatility in, the credit,
banking, and financial markets in the United States. We also may be forced to curtail spending in research and development activities
in order to conserve cash.
Additional financings will be needed by us to
fund our operations, including making the $2.5 million payment on or before July 1, 2024 pursuant to the Settlement Agreement or pursuant
to any damages awarded by the Chancery Court, and to complete clinical development of and to commercially develop our product candidates.
There is no assurance that such financing will be available when needed or on acceptable terms. We also may be forced to curtail spending
in research and development activities in order to conserve cash.
Global Macroeconomic Environment
The global macroeconomic environment could be
negatively affected by, among other things, resurgence of COVID-19 or other pandemics or epidemics, instability in global economic markets,
increased U.S. trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain weaknesses,
instability in the geopolitical environment as a result of the withdrawal of the United Kingdom from the European Union, the ongoing conflict
between Russia and Ukraine, the war in the Middle East, other political tensions, and foreign governmental debt concerns. Such challenges
have caused, and may continue to cause, uncertainty and instability in local economies and in global financial markets.
While expected to be temporary, these disruptions
may negatively impact our results of operations, financial condition, and liquidity in 2024 and potentially beyond.
Recently Issued Accounting Standards
No relevant recent accounting pronouncements
noted.
JOBS Act
On April 5, 2012, the Jumpstart Our Business
Startups Act of 2012 (“JOBS Act”) was signed into law. The JOBS Act contains provisions that, among other things, reduce
certain reporting requirements for an “emerging growth company”. As an “emerging growth company,” we are electing
to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards,
and as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is
required for non-emerging growth companies. Section 107 of the JOBS Act provides that our decision not to take advantage of the
extended transition period is irrevocable. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,”
we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls
over financial reporting pursuant to Section 404, (ii) provide all of the compensation disclosure that may be required of non-emerging
growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that
may be adopted by the Public Company Accounting Oversight Board regarding reporting and critical audit matters, and (iv) disclose
certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of
the chief executive officer’s compensation to median employee compensation. These exemptions will apply until the last day of the
fiscal year including the fifth anniversary of the completion of our initial public offering or until we no longer meet the requirements
for being an “emerging growth company,” whichever occurs first.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
Not Applicable.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY
DATA
The information required by this item appears
in a separate section of this Annual Report on Form 10-K beginning on page F-1 and is incorporated herein by reference.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH
ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our
Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December
31, 2023. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act,
means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in
the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods
specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange
Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers,
as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies
its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure
controls and procedures as of December 31, 2023, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date,
our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Annual Report on Internal
Control Over Financial Reporting
Our management is responsible for establishing
and maintaining adequate internal control over our financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and
15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial
Officer, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability
of our financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted
accounting principles, and includes those policies and procedures that:
| |
● |
Pertain to the maintenance
of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets; |
| |
● |
provide reasonable assurance
that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting
principles, and that receipts and expenditures are being made only in accordance with the authorizations of management and directors;
and |
| |
● |
provide reasonable assurance
regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material
effect on our financial statements. |
Under the supervision and with the participation
of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness
of our internal control over financial reporting based on the framework provided in Internal Control — Integrated
Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation,
our management concluded that our internal control over financial reporting was effective as of December 31, 2023.
Changes in Internal Control Over Financial
Reporting
There were no changes in our internal controls
over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) and 15d-15(d) of the
Exchange Act that occurred during the quarter ended December 31, 2023 that materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive
Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting
are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However,
our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent
all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance
that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control
systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.
These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because
of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two
or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions
about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under
all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance
with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due
to error or fraud may occur and not be detected.
ITEM 9B. OTHER INFORMATION
During the three months ended December 31, 2023,
no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non Rule 10b5-1
trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
On March 25, 2024, we
entered into our standard director and officer indemnification agreement with Vinay Shah, a copy of which has been filed as an exhibit
to this Annual Report on Form 10-K. The Indemnification Agreement provides for indemnification against expenses, judgments, fines and
penalties actually and reasonably incurred by an indemnitee in connection with threatened, pending or completed actions, suits or other
proceedings, subject to certain limitations. The Indemnification Agreement also provides for the advancement of expenses in connection
with a proceeding prior to a final, nonappealable judgment or other adjudication, provided that the indemnitee provides an undertaking
to repay to us any amounts advanced if the indemnitee is ultimately found not to be entitled to indemnification by us. The Indemnification
Agreement sets forth procedures for making and responding to a request for indemnification or advancement of expenses, as well as dispute
resolution procedures that will apply to any dispute between us and an indemnitee arising under the Indemnification Agreement.
In addition, and subject
to certain limitations, the Indemnity Agreement provides for the advancement of expenses incurred by or on behalf of the Indemnitee in
connection with any proceeding not initiated by the Indemnitee, and the reimbursement to us of the amounts advanced (without interest)
to the extent that it is ultimately determined that the Indemnitee is not entitled to be indemnified by us.
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND
CORPORATE GOVERNANCE
Executive Officers and Directors
The following sets forth certain information
with respect to our officers and directors.
| Name
|
|
Age |
|
Position |
| Executive Officers |
|
|
|
|
| Gerald Bruce |
|
67 |
|
Chief Executive Officer (Principal Executive Officer)
and Class I Director |
| Jeffrey Gudin, MD |
|
58 |
|
Executive Vice President, Chief Medical Officer, and
Class III Director |
| Vinay Shah |
|
61 |
|
Chief Financial Officer (Principal Financial and Accounting
Officer) and Corporate Secretary |
| Sheila A. Mathias, PhD, J.D., MBA |
|
56 |
|
Chief Scientific Officer |
| |
|
|
|
|
| Directors |
|
|
|
|
| Eric Floyd, PhD |
|
61 |
|
Independent Class III Chairman of the Board of Directors
and Compensation Committee Chair |
| Jerrold Sendrow, CFP |
|
79 |
|
Independent Class II Director and Audit Committee Chair |
| Thani Jambulingam, PhD |
|
60 |
|
Independent Class II Director and Corporate Governance
Committee Chair |
| Vanila M. Singh, MD |
|
53 |
|
Independent Class I Director |
| Michael F. Dubin, CPA |
|
69 |
|
Independent Class II Director |
| Barbara A. Ruskin, PhD, J.D. |
|
63 |
|
Independent Class I Director |
Executive Officers
Gerald W. Bruce has served as our
Chief Executive Officer since November 20, 2023, as a director since July 2021 and as our Executive Vice President and our Commercial
Operations Officer from August 2017 until his appointment as our Chief Executive Officer. Mr. Bruce has spent over 30 years,
including 20 years in senior leadership roles, in the Pharmaceutical and Medical Nutrition industry. He started his career in May 1983
at Johnson & Johnson Inc. where he was an award-winning sales representative and held leadership positions of increasing responsibility
in sales and marketing ending with his role as Group Product Director of Analgesics in September 1998. From September 1998 to November 2000,
he served as Vice President of Sales at Bristol-Myers Squibb Co. where he led the Cardiovascular and Metabolic sales force. From November 2000
to January 2006, he served as Vice President of Managed Markets where he led the team responsible for the development and implementation
of the reimbursement strategy for Bristol-Myers Squibb’s US portfolio. From January 2006 to June 2008, Mr. Bruce was the
Senior Vice President of Commercial Operations at NitroMed, Inc. where he was responsible for building the commercial strategy and led
the team responsible for the development and implementation of the commercial plan for the start-up company’s first product for
the treatment of heart failure. From April 2009 to November 2018, Mr. Bruce served as Vice President of Sales for Nutricia North
America, Danone Medical Nutrition Division. Mr. Bruce currently serves on the Board of Trustees for Lincoln University and is a Board
member for the National Sales Network. He received his bachelor’s degree in business administration from Lincoln University and
a master’s degree in leadership from the McDonough School of Business at Georgetown University. Mr. Bruce was selected as a director
due to his extensive experience at pharmaceutical companies and knowledge of the pharmaceutical industry.
Jeffrey Gudin, MD, one of our co-founders,
became an Executive Vice President, and our Chief Medical Officer in January 2017. Prior to joining us, Dr. Gudin, was Director
of Pain Management and Palliative Care at Englewood Hospital and Medical Center in New Jersey for almost 20 years. He is on faculty
at the University of Miami, Miller School of Medicine. Dr. Gudin is Board Certified in Pain Medicine, Anesthesiology, Addiction
Medicine and Hospice and Palliative Medicine. He is an active speaker in the field of pain management. His clinical and research focus
includes pain management, opioid abuse and potential solutions, and increasing clinician awareness of pain assessment and risk management.
Dr. Gudin completed residency in anesthesiology at Yale University School of Medicine, in New Haven, Connecticut. He continued his
training with an extended postdoctoral fellowship in pain medicine at the Yale Center for Pain Management, where he was actively involved
in research and teaching. Dr. Gudin was selected as a director due to his extensive experience in the field of pain management, opioid
abuse and palliative care.
Vinay Shah became our Chief Financial
Officer in June 2023. Previously, Mr. Shah served as the Chief Financial Officer of Aravive, Inc. from October 2018 until June 2022. Mr.
Shah also served as the Chief Financial Officer of Aravive Biologics, Inc. from 2010 until June 2022, initially as a consultant and from
2017 as an employee. Mr. Shah brings more than 20 years of financial management experience in the medical device and biopharmaceutical
industries to our company. From 2008 until 2016, he served in various positions at Pacira Pharmaceuticals Inc., a specialty pharmaceutical
company, including Executive Director of Finance and Executive Director of Strategy Analytics, initially as a consultant and since 2010
as an employee. Before Pacira Pharmaceuticals Inc., Mr. Shah worked for Cardinal Health’s medical device group in various finance
management positions. The group was subsequently consolidated and spun off as CareFusion and then sold to Becton, Dickinson and Company.
His prior work experience includes positions at Pricewaterhouse Coopers LLP and KPMG in India and the Middle East. Mr. Shah received a
Bachelor of Commerce degree from Ranchi University in India. He is a Chartered Accountant from the Institute of Chartered Accountants
in India and has an MBA from W.P. Carey School of Business at Arizona State University.
Sheila A. Mathias, PhD, JD became
our Chief Scientific Officer in April 2021. Dr. Mathias has more than 20 years of leadership experience in the pharmaceutical industry
accelerating drug development. She brings extensive global regulatory affairs strategic guidance and clinical development experience
having worked across a range of therapeutic areas, including pain management, addiction medicine, and dermatology. This experience has
spanned across big pharma, mid-sized, to start-up biotechnology companies. Most recently, she held the position Senior Director Global
Regulatory Affairs at Sun Pharma Advanced Research Company from 2018 to 2021. Since 2018 she has served on the Advisory Board for Tennessee
State University Department of Biology. Dr. Mathias has held increasing roles of responsibility, entering the pharmaceutical industry
at Merck US Human Health in the position of Medical Science Liaison. Dr. Mathias transitioned into Regulatory Affairs at Aventis Pharmaceuticals
and has successfully brought multiple products through regulatory approval. Her experience includes roles at Braeburn Pharmaceuticals
from 2015 to 2018, Otsuka Pharmaceuticals from 2013 to 2018, Actelion Clinical Research from 2012 to 2013, Cephalon from 2007 to 2011,
Novartis Pharmaceuticals from 2005 to 2007 and Aventis Pharmaceuticals from 2002 to 2005. Dr. Mathias received a B.S in Zoology from
Howard University, a PhD in Neurophysiology from Meharry Medical College, an executive MBA from Saint Joseph’s University, and
a JD from Northwestern California University School of Law.
Directors
Eric Floyd, PhD became a director
in January 2017. Dr. Floyd was appointed as the Chairman of our Board of Directors effective November 20, 2023. Dr. Floyd currently
serves as Chief Regulatory Officer at Neurogene Inc. He has nearly 21 years of regulatory experience within the pharmaceutical industry.
Most recently, from November 2018 to December 2019 he was Senior Vice President, Regulatory Affairs, for Axovant Sciences. Prior
to that, he served as President of Compliance Services and Chief Scientific Officer at Dohmen Life Science Services, Inc. from June 2015,
Senior Vice President, U.S. Regulatory Affairs and Clinical Quality Compliance at Lundbeck Inc. December 2011, Global Vice President
of Regulatory Affairs at Hospira Inc. (later acquired by Pfizer Inc.) from January 2010, Vice President of Worldwide Regulatory Affairs
and Quality Assurance at Cephalon Inc. (later acquired by Teva Pharmaceuticals Industries Ltd.) from January 2007 and VP and Global
Head of Respiratory, Dermatology, and Tropical Medicines Drug Regulatory Affairs at Novartis AG from February 2005. Dr. Floyd
has also held senior leadership roles at Bristol Myers Squibb Co., Aventis Pharma and Merck Research Laboratories (a division of Merck &
Co.). Dr. Floyd received a Ph.D. in Neurophysiology from Meharry Medical College, Nashville, an executive MBA from St. Joseph’s
University, Philadelphia, an MS from Tennessee State University, a BS from the University of Illinois and has served as an Assistant Professor
at Harvard University School of Medicine. Dr. Floyd served as an outside director on the board of directors of Scilex Pharmaceuticals
Inc. from April 2014 to November 2016. Dr. Floyd was selected as a director due to his extensive experience at pharmaceutical
companies and knowledge of the pharmaceutical industry.
Jerrold Sendrow, CFP became a director
in January 2017. Mr. Sendrow has been a Certified Financial Planner since 1986 and continues to maintain his practice. Mr. Sendrow
also served as an outside Director on the board of directors of SCILEX Pharmaceuticals Inc. from April 2014 to November 2016.
Prior to that, Mr. Sendrow was an accountant in the audit departments of Touche Ross & Co. and Peat Marwick Mitchell &
Co after returning from military service of two tours in the Vietnam conflict. Mr. Sendrow holds business degrees from Bernard Baruch
College of the City University of New York and Adelphi University. Mr. Sendrow was selected as a director due to his leadership
experience at other growth-stage companies and his financial accounting experience.
Thani Jambulingam, PhD became a
director in January 2017. Dr. Jambulingam is a Pfizer Fellow and Professor in the Department of Pharmaceutical and Healthcare
Marketing at St Joseph’s University, Erivan K. Haub School of Business, in Philadelphia, Pennsylvania. He teaches in the executive
MBA program for biopharmaceutical, medical device and physician executives. Dr. Jambulingam served as the chair of the department
for eight years, from June 2003 to June 2010. Dr. Jambulingam’s research is focused on pharmaceutical and healthcare
strategy and innovation. His research is regularly published in marketing and management journals. Dr. Jambulingam has also served
as a consultant and facilitated training sessions in innovation and strategy for senior leadership and/or brand teams within several
small, mid and large pharma and healthcare firms including Alkermes Plc, Abbott Industries, AstraZeneca plc, Cardinal Health, FMC, IQVIA,
Lancaster General Hospital, Inspira Health, Lehigh Valley Health Network, Leo Pharma, Merck & Co., Novo Nordisk, Pfizer Inc.,
Sanofi, Solvay and Procter & Gamble Inc. During his sabbatical from Saint Joseph’s University, from July 2011 to
August 2012, he joined Pfizer Inc. (NYSE: PFE) with the Prevenar Global Commercial Team contributing to development of Prevenar
franchise positioning, healthy aging platform development, vaccine business strategy for emerging markets, pediatric expanded age strategy
(life cycle management) and conducted strategy sessions for executive leadership within the specialty care division of Pfizer. Over the
years, Dr. Jambulingam has successfully mentored several entrepreneurs in the life sciences industry. Dr. Jambulingam is a pharmacist
and obtained his Ph.D. from the University of Wisconsin-Madison. Dr. Jambulingam completed the case method of teaching at Harvard.
He has been inducted to the Rho Chi, the honor society in pharmacy and Beta Gamma Sigma, the honor society for business. In 2021, Dr.
Jambuligam received the Tangelmann Award for lifetime excellence in research and teaching. For the past seven years, Dr. Jambulingam
has been a faculty member conducting Bio-Entrepreneurship Bootcamp at the annual meeting at the Biotechnology Industry Organization (BIO).
Dr. Jambulingam is also a visiting professor in the Wharton MBA Global program and teaches healthcare courses in India. Dr. Jambulingam
was selected as a director due to his expertise in innovation and strategy and his extensive knowledge of the pharmaceutical industry.
Vanila M. Singh, MD became a director
in June 2020. From June 2017 to July 2019, Dr. Singh is the former Chief Medical Officer of the U.S. Department of
Health and Human Services, where she served as the Chairperson of the highly regarded HHS Pain and Opioid Task Force in conjunction with
the Department of Defense and the Veterans Administration. Since November 2019, Dr. Singh has been a director of Biodelivery
Sciences International, Inc., and since June 2004, Dr. Singh has been a clinical associate professor of Anesthesiology, Pain
and Peri-operative Medicine at Stanford University and is a teaching mentor at Walter Reed National Military Medical Center. For over
ten years, Dr. Singh served on medical ethics as well as on scientific editorial boards, committees for the American Society of
Regional Anesthesia, American Society of Interventional Pain Physicians, California Medical Association, and the Santa Clara County Medical
Association. Dr. Singh, who is double board-certified in pain and anesthesiology, focuses her practice on regional anesthesia and
peri-operative, subacute, and the development of chronic pain, with an appreciation for complimentary and traditional medicine approaches
that emphasize an individualized patient-centered approach. Dr. Singh received her medical degree from George Washington University
Medical School and her B.A. from U.C. Berkeley in Molecular and Cell Biology and Economics. Dr. Singh was selected as a director
due to her leadership experience and her extensive knowledge of the pharmaceutical industry and the regulatory environment.
Michael F. Dubin, CPA became a
director in July 2021. From 2001 to 2016, Mr. Dubin held the title of Managing Partner, PA/SNJ Offices, with RSMUS LLP (RSM), a professional
services company. He was presented with RSM’s “National Achievement Award” in 2010 and was a finalist for the company’s
“National Integrity Award.” Prior to 2001, Mr. Dubin served as an audit partner for a regional accounting firm and a national
accounting firm. Mr. Dubin obtained a BS in Economics (magna cum laude) from the Wharton School of Business, University of Pennsylvania.
He served as a Board Member for RSM for four years. Mr. Dubin was also a board member and the Audit Committee Chairman for a privately
held business in Philadelphia engaged in supplying energy efficiency services and facilities, and is a board member and the Risk Management
Committee Chairman for a commercial bank in Pennsylvania and an advisory board member for an accounting firm in Pennsylvania. Mr. Dubin
is professionally affiliated with the PICPA and AICPA. He was also an adjunct faculty member and course teacher for the Wharton School
of Business for two years and has also been a guest lecturer at the Wharton School of the University of Pennsylvania, Temple University,
University of Scranton and Lehigh University. He also served as an expert witness/consultant for the Federal Deposit Insurance Corporation
and the Resolution Trust Corporation. Mr. Dubin was selected as a director due to his extensive leadership experience in public accounting
and risk management and exposure to manufacturing, distribution, financial services, business and professional services, pharma, technology,
retail and various other industries.
Barbara A Ruskin, PhD, JD became
a director in March 2023. Dr. Ruskin brings over 25 years of experience in life science intellectual property and corporate law. Since
May 2019, she has served as SVP, General Counsel and Chief Patent Officer and since September 2022 as Chief Intellectual Property and
Innovation Officer for Silence Therapeutics, a Nasdaq listed international biotechnology company. Prior to that, from September 2017
to February 2019 she served as General Counsel and Chief Patent Officer of Molecular Templates Inc. Prior to holding these corporate
positions, Dr. Ruskin served as outside counsel for pharmaceutical and biotechnology companies and their investors, including as an IP
Corporate Partner at Ropes & Gray LLP and as an associate at Fish & Neave LLP, both in New York City. She has advised, managed
and prosecuted worldwide patent portfolios for a number of biotech and pharmaceutical industry clients and has also worked in IP litigation
in both the U.S. and Europe. Dr. Ruskin has since April 2007 served as a member of the Board of Directors at St. Jude Children’s GMP
LLC (Memphis, TN), and served as Chairman of that Board from March 2017-March 2022. From 2016-2019, Dr. Ruskin also served on the Board
of Directors for the Burke Neurological Institute (White Plains, NY). Dr. Ruskin did her post-doctoral research at the Whitehead Institute
for Biomedical Research (MIT) and at the Institute for Neuroscience (University of Oregon). She has published numerous scientific articles
and given legal presentations that combine her knowledge of biochemistry and law. In addition to her Ph.D. in Biochemistry & Molecular
Biology, received from Harvard University, Dr. Ruskin received a B.A. in Biochemistry from the University of California, Berkeley, and
her J.D. from Fordham University School of Law. Dr. Ruskin was selected as a director due to her leadership experience in corporate
and intellectual property law with publicly listed biotechnology companies and extensive knowledge of the biotech and pharmaceutical
industry.
Corporate Governance
Our bylaws delegate the authority over our management
and officers to our Board of Directors. The Board of Directors may then delegate management of the Company to committees of the Board
of Directors, or such other persons based on its reasonable discretion. Regardless of any delegation, the Board of Directors will remain
responsible for the proper management of our affairs. The Board of Directors may create new committees or change the responsibilities
of existing committees from time to time.
Board Structure and Committee Composition
Our business and affairs are managed under the
direction of our Board of Directors. Our Board of Directors currently consists of eight directors. The Certificate of Incorporation provides
that our Board of Directors shall consist of at least one director but not more than nine directors and that the number of directors
may be fixed from time to time by resolution of our Board of Directors.
In accordance with the terms of the Certificate
of Incorporation and bylaws, our Board of Directors is divided into three classes, Class I, Class II and Class III, with each class serving
staggered three-year terms. Upon the expiration of the term of a class of directors, directors in that class are eligible to be elected
for a new three-year term at the annual meeting of stockholders in the year in which their term expires. Our directors are divided among
the three classes as follows:
| |
● |
The Class I directors are
Mr. Bruce, Dr. Singh and Dr. Ruskin; their terms will expire at the 2025 annual meeting of stockholders. |
| |
● |
The Class II directors
are Dr. Jambulingam, Mr. Sendrow and Mr. Dubin; their terms will expire at the 2026 annual meeting of stockholders. |
| |
● |
The Class III directors are Dr. Gudin and Dr. Floyd; their
terms will expire at the 2024 annual meeting of stockholders. |
We expect that any additional directorships resulting
from an increase in the number of directors will be distributed among the three classes so that, as nearly as possible, each class will
consist of one-third of the directors. The division of our Board of Directors into three classes with staggered three-year terms may
delay or prevent a change of our management or a change in control.
Under our Certificate of Incorporation, directors
have the authority to appoint one or more directors to our Board of Directors, subject to the maximum number of directors allowed for
in our Certificate of Incorporation. A vacancy on our Board of Directors may be filled by the remaining directors and any director so
appointed will hold office until our next annual general meeting. During any vacancy on our Board of Directors, the remaining directors
will have full power to act as the board.
We have an Audit Committee, a Compensation Committee,
a Nominating and Corporate Governance Committee and a Science and Technology Committee with the composition and responsibilities described
below. Each committee operates under a written charter that has been approved by our Board of Directors, the full text of which is available
on our website at www.virpaxpharma.com. The members of each committee are appointed by the Board of Directors and serve until their
successor is elected and qualified unless they are removed or resign earlier. In addition, from time to time, special committees may be
established under the direction of the Board of Directors when necessary to address specific issues.
Audit Committee
Our Audit Committee is comprised of Mr. Dubin,
Mr. Sendrow, Dr. Floyd, and Dr. Jambulingam, with Mr. Sendrow serving as Chairman of the audit committee. Our Board of Directors
has determined that each member of the Audit Committee meets the independence requirements of Rule 10A-3 under the Exchange Act
and the applicable rules of the Nasdaq Capital Market. Our Board of Directors has determined that Mr. Dubin is an “audit committee
financial expert” within the meaning of SEC regulations and the applicable rules of the Nasdaq Capital Market. The Audit Committee’s
responsibilities include:
| |
● |
appointing, approving the
compensation of, and assessing the qualifications, performance and independence of our independent registered public accounting firm,
and in particular the provision of additional services to each entity covered by the committee; |
| |
● |
pre-approving audit and
permissible non-audit services, and the terms of such services, to be provided by our independent registered public accounting firm; |
| |
● |
reviewing and discussing
with management and the independent registered public accounting firm our annual and quarterly financial statements and related disclosures
as well as critical accounting policies and practices used by us; |
| |
● |
monitoring the audit of
our financial statements; |
| |
● |
setting policies for our
hiring of employees or former employees of our independent registered public accounting firm; |
| |
● |
reviewing our significant
risks or exposures and assessing the steps that management has taken or should take to monitor and minimize such risks or exposures; |
| |
● |
reviewing the adequacy
of our internal control over financial reporting, including information system controls and security; |
| |
● |
monitoring the effectiveness
of our systems of internal control, internal audit and risk management for each entity covered by the committee; |
| |
● |
establishing policies and
procedures for the receipt and retention of accounting-related complaints and concerns; |
| |
● |
recommending, based upon
the audit committee’s review and discussions with management and the independent registered public accounting firm, whether
our audited financial statements shall be included in our Annual Report on Form 10-K; |
| |
● |
monitoring our compliance
with legal and regulatory requirements as they relate to our financial statements and accounting matters; |
| |
● |
preparing the audit committee
report required by the rules of the SEC to be included in our annual proxy statement; |
| |
● |
reviewing all related party
transactions for potential conflict of interest situations and approving all such transactions; and |
| |
● |
reviewing and discussing
with management and our independent registered public accounting firm our earnings releases and scripts. |
Compensation Committee
Our Compensation Committee is composed of Dr. Floyd,
Mr. Sendrow, and Dr. Jambulingam, with Dr. Floyd serving as Chairman of the committee. Our Board of Directors has determined
that each director serving on the Compensation Committee is “independent” in accordance with Rule 10C-1 under the Exchange
Act and as defined under the applicable listing standards of the Nasdaq Capital Market. Further, the Board of Directors has determined
that the directors serving on the Compensation Committee are “non-employee directors” as defined in rule 16b-3 promulgated
under the Exchange Act and are “outside directors” as that term is defined in Section 162(m) of the Internal Revenue
Code of 1986, as amended. The compensation committee’s responsibilities include:
| |
● |
reviewing and approving
corporate goals and objectives relevant to the compensation of our chief executive officer, the officers who report directly to the
chief executive officer and all officers who are “insiders” subject to Section 16 of the Exchange Act; |
| |
● |
evaluating the performance
of our chief executive officer and such other officers in light of such corporate goals and objectives and determining and approving,
or recommending to our Board of Directors for approval, the compensation of our chief executive officer and such other officers; |
| |
● |
appointing, compensating
and overseeing the work of any compensation consultant, legal counsel or other advisor retained by the compensation committee; |
| |
● |
conducting the independence
assessment outlined in the listing standards of the Nasdaq Capital Market with respect to any compensation consultant, legal counsel
or other advisor retained by the compensation committee; |
| |
● |
annually reviewing and
reassessing the adequacy of the committee charter; |
| |
● |
reviewing and establishing
our overall management compensation and our compensation philosophy and policy; |
| |
● |
overseeing and administering
our equity compensation and other compensatory plans; |
| |
● |
reviewing and approving
our equity and incentive policies and procedures for the grant of equity-based awards and approving the grant of such equity-based
awards; |
| |
● |
reviewing and making recommendations
to our Board of Directors with respect to non-employee director compensation; and |
| |
● |
producing a report, if
required, on executive compensation to be included in our annual proxy statement or Annual Report on Form 10-K. |
Nominating and Corporate Governance Committee
Our nominating and corporate governance committee
is composed of Dr. Jambulingam, Mr. Sendrow, and Dr. Floyd, with Dr. Jambulingam serving as Chairman of the committee. Our
Board of Directors has determined that each director serving on the Nominating and Corporate Governance Committee is “independent”
as defined in the applicable rules of the Nasdaq Capital Market. The nominating and corporate governance committee’s responsibilities
include:
| |
● |
establishing procedures
for identifying and evaluating board of director candidates, including nominees recommended by stockholder; |
| |
● |
identifying individuals
qualified to become members of our Board of Directors; |
| |
● |
recommending to our Board
of Directors the persons to be nominated for election as directors and to each of our board’s committees; |
| |
● |
developing and recommending
to our Board of Directors a set of corporate governance principles; |
| |
● |
articulating to each director
what is expected, including reference to the corporate governance principles and directors’ duties and responsibilities; |
| |
● |
reviewing and recommending
to our Board of Directors’ practices and policies with respect to directors; |
| |
● |
reviewing and recommending
to our Board of Directors the functions and duties relative to corporate governance and the composition of the committees of our
Board of Directors; |
| |
● |
reviewing and assessing
the adequacy of the committee charter and submitting any changes to our Board of Directors for approval; |
| |
● |
considering and reporting
to our Board of Directors any questions of possible conflicts of interest of Board of Directors’ members; |
| |
● |
providing for new director
orientation and continuing education for existing directors on a periodic basis; |
| |
● |
performing an evaluation
of the performance of the committee; and |
| |
● |
overseeing the evaluation
of our Board of Directors. |
Science and Technology Committee
Our Science and Technology Committee is comprised
of Dr. Floyd, Dr. Jambulingam, Dr. Singh and Dr. Ruskin, with Dr. Floyd serving as the Chairman of the committee. Our
Science and Technology Committee is responsible for, among other things:
| |
● |
periodically examining
management’s strategic direction and investment in our biopharmaceutical research and development and technology initiatives; |
| |
● |
identifying and discussing
significant emerging science and technology issues and trends; |
| |
● |
evaluating the soundness/risks
associated with the technologies in which we are investing our research and development efforts; and |
| |
● |
periodically reviewing
our overall patent strategies. |
Special Litigation Committee
Our Special Litigation Committee is comprised
of Dr. Floyd, Dr. Jambulingam, Dr. Singh, Dr. Ruskin, Dr. Gudin, Mr. Sendrow and Mr. Dubin with Dr. Floyd serving as the Chairman
of the committee. Our Special Litigation Committee was formed for the purpose of making decisions related to the litigation, the details
of which are more fully disclosed under the sections titled “Risk Factors” and “Business—Recent Developments”
elsewhere in this prospectus.
Code of Business Conduct and Ethics
We have adopted written code of business conduct
and ethics (“Code of Ethics”) that applies to our directors, officers and employees, including our principal executive officer,
principal financial officer, principal accounting officer or controller, or persons performing similar functions. The Code of Ethics
is available on our website at www.virpaxpharma.com. In addition, we intend to post on our website all disclosures that are required
by law or the Nasdaq Capital Market rules concerning any amendments to, or waivers from, any provision of the Code of Ethics. The reference
to our website address does not constitute incorporation by reference of the information contained at or available through our website,
and you should not consider it to be a part of this prospectus.
Legal Proceedings
See the disclosure under Item 3: Legal Proceedings
above for a discussion of the Complaint naming Mr. Mack and the Company as defendants.
ITEM 11. EXECUTIVE COMPENSATION
As an emerging growth company under the JOBS
Act we have opted to comply with the executive compensation disclosure rules applicable to “smaller reporting companies,”
which require compensation disclosure for each of our principal executive officers serving during the most recently completed fiscal
year, the two most highly compensated executive officers (other than our principal executive officer) serving as executive officers at
the end of our most recently completed fiscal year and up to two additional individuals for whom disclosure would have been provided
but for the fact that the individual was not serving as an executive officer of the company at the end of the most
recently completed fiscal year (collectively, our “Named Executive Officers”) for services rendered in all capacities to
us for the years ended December 31, 2023 and December 31, 2022. This section describes the executive compensation program in place for
our Named Executive Officers during the year ended December 31, 2023.
This section discusses the material components
of the executive compensation program for our executive officers who are named in the “Summary Compensation Table” below
and the non-employee members of our Board of Directors. In 2023, our “Named Executive Officers” and their positions
were:
| |
● |
Gerald Bruce, our Chief
Executive Officer; |
| |
|
|
| |
● |
Anthony Mack, our Former
Chief Executive Officer and Former Chairman of the Board of Directors; |
| |
● |
Sheila A. Mathias, PhD,
JD, our Chief Science Officer; |
| |
● |
Vinay Shah, our Chief Financial
Officer; and |
| |
|
|
| |
● |
Christopher Chipman, our
Former Chief Financial Officer. |
This discussion may contain forward-looking statements
that are based on our current plans, considerations, expectations and determinations regarding future compensation programs.
2023 Summary Compensation Table
The following table sets forth information concerning
the compensation of our Named Executive Officers for the years ended December 31, 2023 and 2022:
| Name & Principal Position | |
Year | | |
Salary | | |
Bonus | | |
Option
Awards (1) | | |
All Other Compensation | | |
Total | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| Gerald W. Bruce(2) | |
2023 | | |
$ | 38,000 | | |
$ | 29,000 | | |
$ | 61,000 | | |
$ | - | | |
$ | 128,000 | |
| Chief Executive Officer | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| Anthony Mack | |
2023 | | |
$ | 445,000 | | |
$ | - | | |
$ | 60,000 | | |
$ | 711,000 | | |
$ | 1,216,000 | |
| Former Chief Executive Officer, Chairman(3) | |
2022 | | |
$ | 467,000 | | |
$ | 238,000 | | |
$ | 79,000 | | |
$ | - | | |
$ | 784,000 | |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| Sheila A. Mathias PhD, JD | |
2023 | | |
$ | 308,000 | | |
$ | 115,000 | | |
$ | 75,000 | | |
$ | - | | |
$ | 498,000 | |
| Chief Scientific Officer | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| Vinay Shah(4) | |
2023 | | |
$ | 123,000 | | |
$ | 115,000 | | |
$ | 86,000 | | |
$ | - | | |
$ | 324,000 | |
| Chief Financial Officer | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| Christopher Chipman | |
2023 | | |
$ | 169,000 | | |
$ | - | | |
$ | 75,000 | | |
$ | 247,000 | | |
$ | 491,000 | |
| Former Chief Financial Officer(5) | |
2022 | | |
$ | 296,000 | | |
$ | 90,000 | | |
$ | 81,000 | | |
$ | - | | |
$ | 467,000 | |
| (1) |
Amounts reflect the full grant date fair value of stock options granted
during the years ended December 31, 2023 and 2022 computed in accordance with ASC Topic 718, rather than the amounts paid to or realized
by the named individual. We provide information regarding the assumptions used to calculate the value of the option awards in Note 7 to
our consolidated financial statements included in this Annual Report on Form 10-K. |
| (2) |
Mr. Gerald Bruce was appointed as our
Chief Executive Officer effective as of November 20, 2023. Amounts included in the salary and bonus columns reflect compensation received
as Chief Executive Officer between November 20, 2023 and December 31, 2023. Prior to being appointed as Chief Executive Officer, Mr.
Bruce received equity compensation as a consultant serving as our Executive Vice President of Commercial Operations. |
| (3) |
Mr. Mack resigned as our
Chief Executive Officer effective November 17, 2023. The amount reflected in all Other Compensation represents estimated separation
expense of $711,000. Refer to Note 5- Commitments and Contingencies to our consolidated financial statements included in this Annual
Report on Form 10-K. |
| (4) |
Mr. Shah was appointed
as our Chief Financial Officer effective as of June 20, 2023. Amount reflects compensation received as Chief Financial Officer between
June 20, 2023 and December 31, 2023. |
| (5) |
Mr. Chipman resigned as
our Chief Financial Officer effective June 30, 2023. Amounts reflect in all other Compensation severance paid of $234,000 and COBRA
payments of $13,000 in accordance with his separation agreement effective June 30, 2023. |
Our Board of Directors, in consultation with our
Compensation Committee, annually reviews the compensation paid to our Named Executive Officers to assess the adequacy of the compensation
paid to our Named Executive Officers. These annual assessments are done in order to periodically align our compensation practices with
what our Board of Directors believe to be compensation levels more commensurate with companies of similar size and development stage as
the Company. Pursuant to these annual assessments, on January 29, 2024, the Compensation Committee approved cash bonus awards for their
2023 performance to Mr. Bruce of $29,000 and Mr. Shah and Dr. Mathias of $115,000 each and equity awards of an option to purchase 12,500
shares of our Common Stock to Mr. Bruce and an equity award of an option to purchase 11,200 shares of our Common Stock to each of Mr.
Shah and Dr. Mathias. All of the grants were made under the 2022 Plan. The options have an exercise price of $3.18 per share, the fair
market value of the Common Stock on the date of grant and vests annually over three years commencing one year after the date of grant,
as adjusted pursuant to the 1 to 10 reverse stock split effective March 1, 2024.
On January 25, 2023, the Compensation Committee
approved cash bonus awards and increases to the base salaries for each of our Named Executive Officers based upon the Company’s
and management’s performance in 2022. Based on these assessments, Mr. Mack and Mr. Chipman were awarded bonuses of $238,000 and
$90,000, respectively. In addition, Mr. Mack’s base salary was increased to $494,000 per year and Mr. Chipman’s base salary
was increased to $312,000 per year.
Compensation Arrangements with our Named Executive Officers
Mr. Bruce
Effective November 20, 2023, Mr. Bruce was appointed
to serve as our Chief Executive Officer.
On December 6, 2023, we entered into an employment
agreement with Mr. Bruce (the “Bruce Employment Agreement”). The term of the Bruce Employment Agreement initiated upon the
commencement of the agreement and terminates upon either death, Disability, for Cause, for Good Reason (as such terms are defined in
the Bruce Employment Agreement), or for other reasons by us or Mr. Bruce. Under the Bruce Employment Agreement, Mr. Bruce will be paid
an annual base salary of $500,000 subject to annual increases at the discretion of the Board and will be eligible for an annual bonus
in an amount up to 50% of his base salary, pro-rated for 2023, which will be awarded by the Board in its sole discretion based on the
achievement of Company and personal performance metrics established by the Board on an annual basis. To receive any bonus, Mr. Bruce
must be employed by the Company at the time of payment.
If Mr. Bruce’s employment is terminated
in the event of Disability or death, the Company would have no further obligations under the Bruce Employment Agreement, except for any
Accrued Obligations (as defined in the Bruce Employment Agreement) and any portion of an earned annual bonus which remains unpaid at
the time of termination. If the Company terminates Mr. Bruce’s employment for Cause, the Company would have no further obligation
under the Bruce Employment Agreement, except for any Accrued Obligations due. If the Company’s terminates Mr. Bruce’s employment
other than for Disability or for Cause, in addition to any Accrued Obligations due, subject to Mr. Bruce executing a release, Mr. Bruce
would be entitled to receive (i) severance payments in an amount equal to Mr. Bruce’s base salary for a period of twelve months
after the effective date of the termination; (ii) reimbursement of medical insurance premiums until the earlier of (1) twelve months
or (2) the date Mr. Bruce becomes eligible for medical benefits through another employer, subject to certain conditions; (iii) if vesting
shall not have accelerated under the equity awards then held by Mr. Bruce, the Company will accelerate the vesting of the number of shares
subject to options that would have vested in the twelve (12) month period after his separation, such that, effective as immediately prior
to the separation date, he will be considered to have vested in all options granted to him through, and no later than twelve (12) months
following the date of the separation; and (iv) effective as immediately prior to the separation date, the Company shall extend the period
of time for Mr. Bruce to exercise any vested shares subject to options until the earlier of (1) the expiration date of the applicable
option, or (2) twelve (12) months after his separation date.
If Mr. Bruce terminates his employment for Good
Reason, Mr. Bruce would be entitled to receive the same payments and benefits on the same terms and conditions as would be applicable
upon termination by the Company other than for Disability or for Cause.
Notwithstanding the above description, if Mr.
Bruce’s employment is terminated by Mr. Bruce for Good Reason or by the Company without Cause (other than on account of Mr. Bruce’s
death or Disability), in each case within twelve months following a Change in Control (as defined in the Bruce Employment Agreement),
Mr. Bruce will be entitled to receive any Accrued Obligations due and, subject to Mr. Bruce’s compliance with the terms of the
Bruce Employment Agreement and Mr. Bruce’s execution of a release, the following: (i) a lump sum payment equal to two times the
sum of Mr. Bruce’s base salary for the year in which the termination date occurs (or if greater, the year immediately preceding
the year in which the Change in Control occurs), (ii) a lump sum payment equal to two times the sum of Mr. Bruce’s cash bonus for
the calendar year in which the termination date occurs (or if greater, the year in which the Change in Control occurs), and (iii) accelerated
vesting of any award granted to Mr. Bruce under the 2022 Plan.
Prior to his appointment as our Chief Executive
Officer, Mr. Bruce served as our Executive Vice President, Commercial Operations pursuant to the terms of a consulting agreement that
we entered into with him on April 25, 2023. For his services Mr. Bruce was issued stock options to purchase up to 10,000 shares of our
Common Stock upon execution of the consulting agreement.
Mr. Shah
Effective June 20, 2023, we entered into an employment
agreement with Vinay Shah (the “Shah Employment Agreement”). The term of the Shah Employment Agreement initiated upon the
commencement of the agreement and terminates upon either death, Disability, for Cause, for Good Reason (as such terms are defined in
the Shah Employment Agreement), or for other reasons by us or Mr. Shah. The Shah Employment Agreement provides for Mr. Shah to serve
as the Company’s Chief Financial Officer reporting to the Company’s Chief Executive Officer and provides for an annual base
salary of $312,000, subject to annual increases at the discretion of the Board of Directors. Under the Shah Employment Agreement, Mr.
Shah is eligible for an annual bonus with a target amount equal to 30% of his base salary which will not be pro rated for the first year,
which will be awarded by our Board in its sole discretion based on the achievement of the Company and Mr. Shah of corporate and personal
performance metrics established by the Board on an annual basis. To receive any bonus, Mr. Shah must be employed by the Company at the
time of payment. Mr. Shah may also receive, in the discretion of the Board, equity awards under the 2022 Plan, or any other equity incentive
plan that the Company may adopt in the future. Mr. Shah is also eligible to participate in all vacation and other fringe benefit programs
of the Company to the extent and on the same terms and conditions as are accorded to other senior management employees of the Company.
On June 20, 2023, Mr. Shah was awarded an option to purchase up to 10,000 shares of the Company’s common stock, 25% vesting after
12 months of his continuous services and the remaining 75% vesting in equal monthly installments over the next 24 months.
The Company may terminate the Shah Employment
Agreement upon written notice to Mr. Shah in the event of Disability (as defined in the Shah Employment Agreement), in which event the
Company would have no further obligations under the Shah Employment Agreement, except for any Accrued Obligations (as defined in the
Shah Employment Agreement) and any portion of an earned annual bonus which remains unpaid at the time of termination. The Company may
also terminate the Shah Employment Agreement for Cause (as defined in the Shah Employment Agreement) immediately upon providing written
notice of such termination to Mr. Shah. If the Company terminates the Shah Employment Agreement for Cause, the Company would have no
further obligation under the Shah Employment Agreement, except for any Accrued Obligations due. The Company may terminate the Shah Employment
Agreement other than with respect to a Disability or for Cause immediately upon written notice of termination to Mr. Shah and if it does
so subject to the Company’s receipt of a release, in addition to any Accrued Obligations due, Mr. Shah is entitled to receive (i)
severance payments in an amount equal to Mr. Shah’s base salary for a period of twelve months after the effective date of the termination
and (ii) reimbursement of medical insurance premiums until the earlier of (1) twelve months or (2) the date Mr. Shah becomes eligible
for medical benefits through another employer, subject to certain conditions.
Mr. Shah may terminate his agreement for Good
Reason (as defined in the Shah Employment Agreement) upon providing written notice of such termination to us. If Mr. Shah terminates
his employment for Good Reason, Mr. Shah will be entitled to receive the same payments and benefits on the same terms and conditions
as would be applicable upon termination by the Company other than for Disability or for Cause.
If the Shah Employment Agreement is terminated
by Mr. Shah for Good Reason or by us without Cause (other than on account of Mr. Shah’s death or Disability), subject to the Company’s
receipt of a release in each case within twelve months following a Change in Control (as defined in the Shah Employment Agreement), Mr.
Shah will be entitled to receive the Accrued Obligations and, subject to Mr. Shah’s compliance with the terms of the Shah Employment
Agreement, Mr. Shah will be entitled to receive the following: (i) a lump sum payment equal to two times the sum of Mr. Shah’s
base salary for the year in which the termination date occurs (or if greater, the year immediately preceding the year in which the Change
in Control occurs), (ii) a lump sum payment equal to two times the sum of Mr. Shah’s cash bonus for the calendar year in which
the termination date occurs (or if greater, the year in which the Change in Control occurs), and (iii) accelerated vesting of any award
granted to Mr. Shah under the 2022 Plan.
In connection with his entry into the Shah Employment
Agreement, Mr. Shah entered into a customary Confidential Disclosure Invention Assignment Agreements with the Company.
Dr.
Mathias
On
April 7, 2021, we entered into an employment agreement with Sheila Mathias, (the “Mathias Employment Agreement”). The Mathias
Employment Agreement provides for Dr. Mathias to serve as the Company’s Chief Scientific Officer reporting to the Company’s
Chief Executive Officer and provided for an initial annual base salary of $250,000 which was increased to $312,000 on January 25, 2023
and is subject to annual increases at the discretion of the Board. Under the Mathias Employment Agreement, Dr. Mathias is eligible for
an annual bonus with a target amount equal to 30% of her base salary, awarded by our Board in its sole discretion based on the achievement
of the Company and Dr. Mathias of corporate and personal performance metrics established by the Board on an annual basis. To receive
any bonus, Dr. Mathias must be employed by the Company at the time of payment. Dr. Mathias is also eligible to receive, in the discretion
of the Board, equity awards under the 2022 Plan, or any other equity incentive plan that the Company adopted. Dr. Mathias is also eligible
to receive other customary benefits described in the Mathias Employment Agreement. The Mathias Employment Agreement shall automatically
terminate effective as of the date of Dr. Mathias’ death, or immediately upon written notice to Dr. Mathias in the event of Disability
(as defined in the Mathias Employment Agreement), in which event the Company would have no further obligations under the Mathias Employment
Agreement, except for any Accrued Obligations (as defined in the Mathias Employment Agreement) and any portion of an earned annual bonus
which remains unpaid at the time of termination. We also may terminate the Mathias Employment Agreement for Cause (as defined in the
Mathias Employment Agreement) immediately upon providing written notice of such termination to Dr. Mathias. If we terminate the Mathias
Employment Agreement for Cause, we would have no further obligation under the Mathias Employment Agreement, except for any Accrued Obligations
due. We could terminate the Mathias Employment Agreement without Cause immediately upon written notice of termination to Dr. Mathias.
If we terminate the Mathias Employment Agreement without Cause, in addition to any Accrued Obligations due, Dr. Mathias is entitled to
receive (i) severance payments in an amount equal to Dr. Mathias’ base salary for a period of six months after the effective
date of the termination and (ii) reimbursement of medical insurance premiums until the earlier of (1) six months or (2) the
date Dr. Mathias becomes eligible for medical benefits through another employer, subject to certain conditions.
Dr.
Mathias may terminate her agreement for Good Reason (as defined in the Mathias Employment Agreement) upon providing written notice of
such termination to us. If Dr. Mathias terminates her employment for Good Reason, Dr. Mathias would be entitled to receive the same payments
and benefits on the same terms and conditions as would have been applicable upon termination by us without Cause.
If
the Mathias Employment Agreement is terminated by Dr. Mathias for Good Reason or by us without Cause (other than on account of Dr. Mathias’
death or Disability), in each case within twelve months following a Change in Control (as defined in the Mathias Employment Agreement),
Dr. Mathias shall be entitled to receive the Accrued Obligations and, subject to Dr. Mathias’ compliance with the terms of the
Mathias Employment Agreement, shall be entitled to receive the following: (i) a lump sum payment equal to two times the sum of Dr.
Mathias’ base salary for the year in which the termination date occurs (or if greater, the year immediately preceding the year
in which the Change in Control occurs), (ii) a lump sum payment equal to two times the sum of Dr. Mathias’ cash bonus for
the calendar year in which the termination date occurs (or if greater, the year immediately preceding the year in which the Change in
Control occurs), and (iii) accelerated vesting of any award granted to Dr. Mathias under the equity incentive plan.
The
Mathias Employment Agreement has a term of three years from the effective date and will be extended upon the expiration. In connection
with her entry into the Mathias Employment Agreement, Dr. Mathias entered into a customary Confidential Disclosure Invention Assignment
Agreements with the Company.
Former
Executive Officers
Mr.
Mack.
On
September 18, 2018, we entered into an employment agreement with Mr. Mack, as amended (the “Mack Employment Agreement”).
The term of the Mack Employment Agreement initiated upon the commencement of the agreement and terminates upon either death, disability,
for cause, for good reason, or for other reasons by us or Mr. Mack. Under the Mack Employment Agreement, as amended, Mr. Mack was initially
paid an annual base salary of $375,000 which was amended to $494,000 on January 25, 2023, and was entitled to an annual performance bonus
targeted at an amount equal to 50% of his base salary based on the achievement of our corporate objectives and Mr. Mack’s individual
performance metrics, in each case as established by the Board of Directors in consultation with Mr. Mack. Upon the recommendation of
the Compensation Committee and in consultation with Mr. Mack, the Board of Directors could have awarded Mr. Mack an annual bonus in excess
of the targeted amount. The Mack Employment Agreement could have been terminated by us immediately upon written notice to Mr. Mack, or
by Mr. Mack upon 30 days’ notice provided to us. Concurrent with the execution of his employment agreement, we and Mr.
Mack agreed to an executive confidentiality agreement (the “Executive Confidentiality Agreement”) that contains standard
non-disclosure and non-competition provisions. In the event we terminated the Mack Employment Agreement other than for cause, or Mr.
Mack terminated the employment agreement for good reason, we would have been required to pay him the then effective base salary for a
period of twelve months following the effective date of the termination. However, in the event of such termination, payment of the effective
base salary is subject to the execution of a release of claims and the compliance by Mr. Mack with such release and all terms and provisions
of the employment agreement and Executive Confidentiality Agreement that survive the termination of Mr. Mack’s employment.
Effective
August 15, 2023, we entered into an amendment to the Mack Employment Agreement, which provided that if the Mack Employment Agreement
was terminated by Mr. Mack for Good Reason or by us without Cause (other than on account of Mr. Mack’s death or disability) within
twelve months following a Change in Control (as defined in the Mack Employment Agreement), subject to the Company’s receipt of
a release in each case, Mr. Mack would have been entitled to receive his Accrued Obligations (as defined in the Mack Employment Agreement)
and, subject to Mr. Mack’s compliance with the terms of the Mack Employment Agreement, Mr. Mack would have been entitled to receive
the following: (i) a lump sum payment equal to two times the sum of Mr. Mack’s base salary for the year in which the termination
date occurs (or if greater, the year immediately preceding the year in which the Change in Control occurs), (ii) a lump sum payment equal
to two times the sum of Mr. Mack’s cash bonus for the calendar year in which the termination date occurs (or if greater, the year
in which the Change in Control occurs), and (iii) accelerated vesting of any award granted to Mr. Mack under our 2022 Plan.
Effective
November 17, 2023, Mr. Mack resigned as our Chief Executive Officer.
Mr.
Chipman
On
April 7, 2021, we entered into an employment agreement with Christopher Chipman, as amended (the “Chipman Employment Agreement”).
The Chipman Employment Agreement provided for Mr. Chipman to continue to serve as the Company’s Chief Financial Officer reporting
to the Company’s Chief Executive Officer and provided for an annual base salary of $250,000, which was increased to $312,000 on
January 25, 2023. Under the Chipman Employment Agreement, Mr. Chipman was eligible for an annual bonus with a target amount equal to
30% of his base salary, which will be awarded by our Board of Directors (the “Board”) in its sole discretion based on the
achievement of the Company and Mr. Chipman of corporate and personal performance metrics established by the Board on an annual basis.
Mr. Chipman was also eligible to receive, in the discretion of the Board, equity awards under the 2022 Plan, or any other equity incentive
plan that the Company may adopt in the future and other customary benefits described in the Chipman Employment Agreement.
We
had the right to terminate the Chipman Employment Agreement upon written notice to Mr. Chipman in the event of Disability (as defined
in the Chipman Employment Agreement), in which event we would have no further obligations under the Chipman Employment Agreement, except
for any Accrued Obligations (as defined in the Chipman Employment Agreement) and any portion of an earned annual bonus which remains
unpaid at the time of termination. We also had the right to terminate the Chipman Employment Agreement for Cause (as defined in the Chipman
Employment Agreement) immediately upon providing written notice of such termination to Mr. Chipman and we would have no further obligation
under the Chipman Employment Agreement, except for any Accrued Obligations due. We also had the right to terminate the Chipman Employment
Agreement without Cause immediately upon written notice of termination to Mr. Chipman and we would be obligated to pay Mr. Chipman any
Accrued Obligations due and (i) severance payments in an amount equal to Mr. Chipman’s base salary for a period of six months
after the effective date of the termination and (ii) reimbursement of medical insurance premiums until the earlier of (1) six months
or (2) the date Mr. Chipman becomes eligible for medical benefits through another employer, subject to certain conditions.
Mr.
Chipman had the right to terminate his agreement for Good Reason (as defined in the Chipman Employment Agreement) upon providing written
notice of such termination to us and he would be entitled to receive the same payments and benefits on the same terms and conditions
as would be applicable upon termination by us without Cause.
If
the Chipman Employment Agreement was terminated by Mr. Chipman for Good Reason or by us without Cause (other than on account of
Mr. Chipman’s death or Disability), in each case within twelve months following a Change in Control (as defined in the Chipman
Employment Agreement), Mr. Chipman would have been entitled to receive the Accrued Obligations and, subject to Mr. Chipman’s compliance
with the terms of the Chipman Employment Agreement, Mr. Chipman would be entitled to receive the following: (i) a lump sum payment
equal to two times the sum of Mr. Chipman’s base salary for the year in which the termination date occurs (or if greater, the year
immediately preceding the year in which the Change in Control occurs), (ii) a lump sum payment equal to two times the sum of Mr. Chipman’s
cash bonus for the calendar year in which the termination date occurs (or if greater, the year in which the Change in Control occurs),
and (iii) accelerated vesting of any award granted to Mr. Chipman under the 2022 Plan.
The
Chipman Employment Agreement had a term of three years from the effective date. In connection with his entry into the Chipman Employment
Agreement, Mr. Chipman entered into a customary Confidential Disclosure Invention Assignment Agreements with the Company.
On June 18, 2023, Mr. Chipman notified the Chairman
of the Board of his decision to resign from his position as our Chief Financial Officer to pursue other opportunities. Mr. Chipman’s
employment terminated on June 30, 2023. We entered into a separation agreement and release with Mr. Chipman (the “Separation Agreement”),
effective as of June 30, 2023, providing for (i) the payment to Mr. Chipman of a total of $234,000, (the “Severance Amount”)
in four equal monthly installments of $58,500; (ii) reimbursement of COBRA payments for four months; and (iii) the acceleration of the
vesting of all shares subject to option awards, such options to be exercisable until the Severance Amount was fully paid. Any options
that were not timely exercised were nullified. The Separation Agreement also contained mutual non-disparagement obligations and a mutual
standard release of claims. As of December 31, 2023, all amounts due to Mr. Chipman have been paid and all of his stock options have been
forfeited.
Severance
subject to release of claims
Our
obligation to provide an executive with severance payments and other benefits under each executive’s employment or consulting agreement,
as applicable, is conditioned on the executive signing (and not subsequently revoking) an effective release of claims in favor of us.
Clawback
Policy
The
Board has adopted a clawback policy which requires the clawback of erroneously awarded incentive-based compensation of past or current
executive officers awarded during the three full fiscal years preceding the date on which the issuer is required to prepare an accounting
restatement due to the material noncompliance of the Company with any financial reporting requirement under the federal securities laws.
There is no fault or misconduct required to trigger a clawback.
The
Compensation Committee shall determine, in its sole discretion, the timing and method for promptly recouping such erroneously awarded
compensation, which may include without limitation: (a) seeking reimbursement of all or part of any cash or equity-based award,
(b) cancelling prior cash or equity-based awards, whether vested or unvested or paid or unpaid, (c) cancelling or offsetting
against any planned future cash or equity-based awards, (d) forfeiture of deferred compensation, subject to compliance with Section 409A
of the Internal Revenue Code and the regulations promulgated thereunder, and (e) any other method authorized by applicable law or
contract. Subject to compliance with any applicable law, the Compensation Committee may affect recovery under this policy from any amount
otherwise payable to the executive officer, including amounts payable to such individual under any otherwise applicable Company plan
or program, including base salary, bonuses or commissions and compensation previously deferred by the executive officer.
Equity
compensation
Outstanding
equity awards at fiscal year-end table
The
following table sets forth information concerning the outstanding equity awards held by each of our Named Executive Officers as of December
31, 2023:
| | |
Option Awards | | |
| |
| Name | |
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable | | |
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable | | |
Option
Exercise
Price
($) | | |
Option
Expiration
Date | |
| Gerald Bruce | |
| 1,516 | | |
| — | | |
98.90 | | |
| 3/11/2030 | |
| Chief Executive Officer | |
| 3,000 | | |
| — | | |
46.20 | | |
| 4/7/2031 | |
| | |
| 6,000 | | |
| — | | |
17.60 | | |
| 4/25/2032 | |
| | |
| 10,000 | | |
| — | | |
7.30 | | |
| 4/24/2033 | |
| | |
| | | |
| | | |
| | |
| | |
| Anthony Mack(4) | |
| 2,022 | | |
| — | | |
98.90 | | |
| 2/17/2024 | |
| Former Chief Executive Officer | |
| 4,045 | | |
| — | | |
98.90 | | |
| 2/17/2024 | |
| | |
| 3,333 | | |
| — | | |
46.20 | | |
| 2/17/2024 | |
| | |
| 2,022 | | |
| — | | |
23.40 | | |
| 2/17/2024 | |
| | |
| | | |
| | | |
| | |
| | |
| Sheila A. Mathias, PhD, JD | |
| 1,667 | | |
| 833 | (1) | |
46.20 | | |
| 4/07/2031 | |
| Chief Scientific Officer | |
| 2,023 | | |
| 4,045 | (1) | |
21.30 | | |
| 1/31/2032 | |
| | |
| — | | |
| 11,200 | (1) | |
7.88 | | |
| 1/25/2033 | |
| | |
| | | |
| | | |
| | |
| | |
| Vinay Shah | |
| — | | |
| 10,000 | (2) | |
9.90 | | |
| 6/20/2033 | |
| Chief Financial Officer | |
| | | |
| | | |
| | |
| | |
| | |
| | | |
| | | |
| | |
| | |
| Christopher Chipman(3) | |
| - | | |
| - | | |
- | | |
| - | |
| Former Chief Financial Officer | |
| | | |
| | | |
| | |
| | |
| (1) |
These
options vest equally over 3 years starting one year after anniversary date. |
| (2) |
These
options vest 25% after 12 months from the hire date (June 20, 2023) and the remaining 75% will vest in equal monthly installments
over the next 24 months. |
| (3) |
All
of Mr. Chipman’s option awards were forfeited in October of 2023. |
| (4) |
All of Mr. Mack’s options awards were forfeited in February of
2024. |
Securities
Authorized for Issuance Under Equity Compensation Plans
The
following table provides information with respect to our compensation plans under which equity compensation was authorized as of December
31, 2023.
| | |
Number of
securities
to be
issued
upon
exercise of
outstanding
options,
warrants
and rights | | |
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) | |
| Plan category | |
(a) | | |
(b) | | |
(c) | |
| Equity compensation plans approved by security holders | |
| 175,686 | (1) | |
$ | 34.60 | | |
| 116,511 | (2)(3) |
| Equity compensation plans not approved by security holders | |
| - | | |
| - | | |
| - | |
| Total | |
| 175,686 | | |
$ | 34.60 | | |
| 116,511 | |
| (1) |
Includes
98,886 and 76,800 shares of common stock issuable upon exercise of outstanding options pursuant to the 2017 Plan and the
2022 Plan, respectively, as of December 31, 2023. |
| (2) |
In
accordance with the “evergreen” provision in the 2022 Plan, an additional 23,428 shares were automatically made available
for issuance on the first day of 2024, which represents 2% of the number of shares outstanding on December 31, 2023; these shares
are excluded from this calculation. |
| (3) |
Includes
0 and 116,511 shares of common stock available for issuance under the 2017 Plan and the 2022 Plan, respectively, as of December
31, 2023. |
Employee
benefits plans
We
currently provide broad-based health and welfare benefits that are available to all of our employees, including our Named Executive Officers,
including medical, dental, vision, life and disability insurance.
Director
Compensation
The
following table sets forth information concerning the compensation paid to our non-employee directors, as well as employee directors
who are not Named Executive Officers, during the year ended December 31, 2023:
| Name | |
Fees Earned or Paid in Cash ($) | | |
Option
Awards ($)(1)(3) | | |
Total
($) | |
| Eric Floyd, PhD | |
$ | 55,000 | | |
$ | 23,850 | | |
$ | 78,850 | |
| Jerrold Sendrow, CFP | |
$ | 55,000 | | |
$ | 18,550 | | |
$ | 73,550 | |
| Thani Jambulingam, PhD | |
$ | 55,000 | | |
$ | 21,200 | | |
$ | 76,200 | |
| Vanila M. Singh, MD | |
$ | 55,000 | | |
$ | 7,950 | | |
$ | 62,950 | |
| Michael F. Dubin | |
$ | 55,000 | | |
$ | 10,600 | | |
$ | 65,600 | |
| Barbara A. Ruskin, PhD, J.D. | |
$ | 46,000 | | |
$ | 17,750 | | |
$ | 63,750 | |
| Jeffrey Gudin, MD (2) | |
$ | 158,000 | | |
$ | 34,000 | | |
$ | 192,000 | |
| (1) |
Amounts
reflect the full grant date fair value of stock options granted during 2023 computed in accordance with ASC Topic 718, rather
than the amounts paid to or realized by the named individual. We provide information regarding the assumptions used to calculate
the value of the option awards in Note 7 to our financial statements included in this Annual Report on Form 10-K. |
| (2) |
The
amount shown in fees earned or paid in cash of $158,000 and options granted of $34,000 was earned in his capacity as an employee
and not as a director. |
| (3) | The
table below shows the aggregate number of option awards outstanding at fiscal year-end for each of our non-employee directors, as well
as employee directors who are not Named Executive Officers, who served as directors during the year ended December 31, 2023. |
| Name | |
Number of Shares
Subject to
Outstanding
options as of
December 31,
2023 | |
| Jeffrey Gudin, MD | |
| 20,617 | |
| Eric Floyd, PhD | |
| 11,066 | |
| Jerrold Sendrow, CFP | |
| 9,054 | |
| Thani Jambulingam, PhD | |
| 9,756 | |
| Vanila M. Singh, MD | |
| 5,549 | |
| Michael F. Dubin | |
| 5,231 | |
| Barbara Ruskin, PhD, J.D. | |
| 2,500 | |
Non-Employee
Director Compensation Policy
The
2022 Plan includes a director compensation policy which provides for:
| |
● |
on
January 1 of each year, each non-employee director will be granted Stock Options under the 2022 Plan to purchase 1,500 shares of
our common stock. |
| |
● |
each
new non-employee director will be granted Stock Options under the 2022 Plan to purchase up to 2,500 shares of our common stock,
as determined by the Compensation Committee, at the time the individual first becomes a director. |
| |
● |
on
January 1, of each year, each then serving non-Chair member of the Audit Committee, the Compensation Committee, the Nominating and
Corporate Governance Committee and the Science and Technology Committee shall automatically be granted Stock Options to purchase
500 shares of common stock under the 2022 Plan, and the Chair of the Audit Committee, the Compensation Committee, the Nominating
and Corporate Governance Committee and the Science and Technology Committee shall each be granted Stock Options to purchase 1,000
shares of common stock under the 2022 Plan. |
In
addition, our non-employee directors receive a cash payment $60,000 per year.
On
January 1, 2023, options were granted to the Non-Employee Directors pursuant to the 2022 Plan to purchase an aggregate of 15,500 shares
of Common Stock, with all grants being made under the 2022 Plan. The options have an exercise price of $6.22 per share, the fair market
value of the Common Stock on the date of grant. The options granted to the directors will vest upon the one-year anniversary of the grant
date and have a ten-year expiration date.
On
January 29, 2024, options to purchase 4,500 shares of Common Stock were granted to Dr Floyd for service as Chair of the Board of Directors
and each other the Non-Employee Directors was granted an option to purchase an aggregate of 2,500 shares of Common Stock, with all grants
being made under the 2022 Plan. The options have an exercise price of $3.18 per share, the fair market value of the Common Stock on the
date of grant. The options granted to the directors will vest upon the one-year anniversary of the grant date and have a ten-year expiration
date.
Limitation
of Directors Liability and Indemnification
The
Delaware General Corporation Law authorizes corporations to limit or eliminate, subject to certain conditions, the personal liability
of directors to corporations and their stockholder for monetary damages for breach of their fiduciary duties. Our Certificate of Incorporation
limits the liability of our directors to the fullest extent permitted by Delaware law. In addition, we have entered into indemnification
agreements with all of our directors and named executive officers whereby we have agreed to indemnify those directors and officers to
the fullest extent permitted by law, including indemnification against expenses and liabilities incurred in legal proceedings to which
the director or officer was, or is threatened to be made, a party by reason of the fact that such director or officer is or was a director,
officer, employee or agent of ours, provided that such director or officer acted in good faith and in a manner that the director or officer
reasonably believed to be in, or not opposed to, our best interests.
We have director and officer liability insurance
to cover certain liabilities our directors and officers may incur in connection with their services to us, including matters arising under
the Securities Act. Our Certificate of Incorporation and bylaws provide that we will indemnify our directors and officers who, by reason
of the fact that he or she is or was one of our officers or directors of our Company, is involved in any action, suit or proceeding, whether
civil, criminal, administrative or investigative related to their board role with us. However, there is no further director and officer
insurance coverage available with respect to the Action or potential claims by Mr. Mack related thereto as set forth under Part I. Item
3. Legal Matters.
Indemnification
Agreements
We
have entered into Indemnification Agreements with each of our current directors and executive officers. The Indemnification Agreements
provide for indemnification against expenses, judgments, fines and penalties actually and reasonably incurred by an indemnitee in connection
with threatened, pending or completed actions, suits or other proceedings, subject to certain limitations. The Indemnification Agreements
also provide for the advancement of expenses in connection with a proceeding prior to a final, nonappealable judgment or other adjudication,
provided that the indemnitee provides an undertaking to repay to us any amounts advanced if the indemnitee is ultimately found not to
be entitled to indemnification by us. The Indemnification Agreement sets forth procedures for making and responding to a request for
indemnification or advancement of expenses, as well as dispute resolution procedures that will apply to any dispute between us and an
indemnitee arising under the Indemnification Agreements.
Incentive
plans
2022
Incentive Plan
On
June 14, 2022, the Company established the 2022 Plan, at which time all new grants of awards were made under the 2022 Plan and no new
grants of awards have been made under the 2017 Plan. The Company believes that offering ownership interests in the Company is a key factor
in retaining and recruiting employees, officers, non-employee directors and other individual service providers, and aligning and increasing
their interests in the Company’s success.
2017
Incentive Plan
On
May 20, 2017, our Board of Directors adopted the 2017 Plan, and on May 21, 2018, our Board of Directors approved the Amended and Restated
2017 Plan, which was further amended on April 25, 2020. The purpose of the 2017 Plan is to encourage the participants to contribute materially
to our growth as a company, thereby benefitting our stockholders, and aligning the economic interests of the participants with those
of the stockholders. As noted above, upon the approval of the 2022 Plan, all new grants of awards are made under the 2022 Plan and no
new grants of awards will be made under the 2017 Plan.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Security
Ownership of Certain Beneficial Owners and Management
The following table sets forth information with
respect to the beneficial ownership of our common stock, as of March 22, 2024:
| |
● |
each
person or group of affiliated persons known by us to beneficially own more than 5% of our common stock; |
| |
● |
each
of our executive officers; |
| |
● |
each
of our directors; and |
| |
● |
all
of our executive officers and directors as a group. |
The number of shares beneficially owned by each
stockholder is determined under rules issued by the SEC. Under these rules, beneficial ownership includes any shares as to which the individual
or entity has sole or shared voting power or investment power. Applicable percentage ownership is based on 1,171,233 shares of common
stock outstanding as of March 22, 2024. In computing the number of shares beneficially owned by an individual or entity and the percentage
ownership of that person, shares of common stock subject to the exercise of options, warrants or other rights held by such person that
are currently exercisable or will become exercisable within 60 days of March 22, 2024 are counted as outstanding. Unless noted otherwise,
the address of all listed stockholder is 1055 Westlakes Drive, Suite 300, Berwyn, PA 19312. Each of the stockholder listed has sole voting
and investment power with respect to the shares beneficially owned by the stockholder unless noted otherwise, subject to community property
laws where applicable.
| Name of Beneficial Owner | |
Number of
Shares
Beneficially
Owned | | |
Percentage of
Shares
Beneficially
Owned | |
| 5% or Greater Stockholders | |
| | |
| |
| Virpax Pharmaceuticals, LLC | |
| 273,043 | (3) | |
| 23.3 | % |
| | |
| | | |
| | |
| Named Executive Officers and Directors Other Than 5% or Greater Stockholders | |
| | | |
| | |
| Gerald Bruce | |
| 20,920 | (1) | |
| 1.8 | % |
| Vinay Shah | |
| — | (2) | |
| — | |
| Anthony P. Mack | |
| 25,255 | (3)(4) | |
| 2.1 | % |
| Sheila Mathias, PhD, J.D., MBA | |
| 9,445 | (5) | |
| * | |
| Jeffrey Gudin, MD | |
| 14,352 | (6) | |
| * | |
| Eric Floyd, PhD | |
| 11,866 | (7) | |
| * | |
| Jerrold Sendrow, CFP | |
| 9,954 | (8) | |
| * | |
| Thani Jambulingam, PhD | |
| 9,856 | (9) | |
| * | |
| Vanila Singh, MD, MACM | |
| 5,549 | (10) | |
| * | |
| Michael F. Dubin | |
| 5,231 | (11) | |
| * | |
| Barbara A. Ruskin, PhD, J.D. | |
| 2,500 | (12) | |
| * | |
| Christopher Chipman | |
| — | (13) | |
| — | |
| Directors and Officers as a Group (12 persons) | |
| 114,927 | | |
| 9.1 | % |
| * |
Less than 1%. |
| (1) |
Includes 404 shares of common stock and 20,516 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of March 22, 2024. |
| (2) |
Does not include 10,000 shares of common stock issuable upon exercise of stock options that are not exercisable within 60 days of March 22, 2024. |
| (3) |
Anthony Mack, our Former Chief Executive Officer, and Jeffrey Gudin, our Executive Vice President and Chief Medical Officer, are the members of Virpax Pharmaceuticals, LLC. Due to Mr. Mack’s ownership of 88.8888% of the outstanding member units of Virpax Pharmaceuticals, LLC, he may be deemed to have sole voting and dispositive control over the shares of our common stock held by Virpax Pharmaceuticals, LLC. As a result, Mr. Mack may be deemed to beneficially own the shares of our common stock held by Virpax Pharmaceuticals, LLC. Mr. Mack resigned as our Chief Executive Officer and Chair of the Board, effective November 17, 2023. |
| (4) |
Includes 25,255 shares of common stock held by Mr. Mack and his spouse. |
| (5) |
Includes 9,445 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of March 22, 2024. Does not include 10,323 shares of common stock issuable upon exercise of stock options that are not exercisable within 60 days of March 22, 2024. |
| (6) |
Includes 758 shares of common stock, and 13,594 shares of common stock issuable upon exercise of stock options exercisable within 60 days of March 22, 2024. Does not include 7,023 shares of common stock issuable upon exercise of stock options that are not exercisable within 60 days of March 22, 2024. |
| (7) |
Includes 800 shares of common stock, and 11,066 shares of common stock issuable upon exercise of stock options exercisable within 60 days of March 22, 2024. |
| (8) |
Includes 900 shares of common stock and 9,054 shares of common stock issuable upon exercise of stock options exercisable within 60 days of March 22, 2024. |
| (9) |
Includes 100 shares of common stock and includes 9,756 shares of common stock issuable upon exercise of stock options exercisable within 60 days of March 22, 2024. |
| (10) |
Includes 5,549 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of March 22, 2024. |
| (11) |
Includes 5,231 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of March 22, 2024. |
| (12) |
Includes 2,500 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of March 22, 2024. |
| (13) |
Mr. Chipman resigned as our Chief Financial Officer, effective June 30, 2023. |
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The
following includes a summary of transactions since January 1, 2022 to which we have been a party in which the amount involved exceeded
or will exceed the lesser of $120,000 or 1% of the average of our total assets as of December 31, 2023 and 2022, and in which any of
our directors, executive officers or, to our knowledge, beneficial owners of more than 5% of our capital stock or any member of the immediate
family of any of the foregoing persons had or will have a direct or indirect material interest, other than equity and other compensation,
termination, change in control and other arrangements, which are described under “Executive and Director Compensation.”
There
were no related party transactions during the years ended December 31, 2023 and 2022.
Policies
and Procedures for Related Party Transactions
Our
Board of Directors has adopted a written related person transaction policy setting forth the policies and procedures for the review and
approval or ratification of related person transactions. This policy covers, with certain exceptions set forth in Item 404 of Regulation
S-K under the Securities Act, any transaction, arrangement or relationship, or any series of similar transactions, arrangements
or relationships, in which we were or are to be a participant, where the amount involved exceeds the lesser of $120,000 or 1% of the
average of our total assets as of December 31, 2023 and 2022 and a related person had, has or will have a direct or indirect material
interest, including without limitation, purchases of goods or services by or from the related person or entities in which the related
person has a material interest, indebtedness, guarantees of indebtedness and employment by us of a related person. In reviewing and approving
any such transactions, our audit committee is tasked to consider all relevant facts and circumstances, including, but not limited to (i) whether
the transaction is on terms comparable to those that could be obtained in an arm’s length transaction with an unrelated party;
(ii) the extent of the related person’s interest in the transaction; (iii) the benefits to the Company; (iv) the
impact on a director’s independence in the event the related person is a director, an immediately family member of a director or
an entity in which a director is a partner, stockholder or executive officer; (v) the availability of other sources for
comparable products or services; (vi) the terms of the transaction; and (vii) the terms available to unrelated third parties.
Director
Independence
Our
Board of Directors undertook a review of its composition, the composition of its committees and the independence of each director. Based
upon information requested from and provided by each director concerning his or her background, employment and affiliations, including
family relationships, our Board of Directors has determined that Dr. Floyd, Mr. Sendrow, Dr. Jambulingam, Dr. Singh, Mr. Dubin and
Dr. Ruskin do not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities
of a director and that each of these directors is “independent” as that term is defined under the Rules of the Nasdaq
Market and the SEC.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Fees
Paid to the Independent Registered Public Accounting Firm
The
following table summarizes the fees paid for professional services rendered by EisnerAmper LLP, our independent registered public accounting
firm, for each of the last two fiscal years.
| Year ending December 31, | |
2023 | | |
2022 | |
| Audit fees(1) | |
$ | 329,805 | | |
$ | 231,420 | |
| Audit related fees | |
| - | | |
| - | |
| Tax fees | |
| - | | |
| - | |
| All other fees | |
| - | | |
| - | |
| Total | |
$ | 329,805 | | |
$ | 231,420 | |
| (1) |
Audit
fees consist of fees incurred for professional services rendered for the audit of our annual financial statements and review of the
quarterly financial statements, assistance with registration statements filed with the SEC, and services that are normally provided
by our independent registered public accounting firm in connection with regulatory filings or engagements. Audit fees includes fees
of approximately $29,000 for consents and comfort letters in 2022. |
Auditor
Independence
In
our fiscal year ended December 31, 2023, there were no other professional services provided by EisnerAmper LLP, located in Philadelphia,
Pennsylvania, Firm ID: 274, that would have required our audit committee to consider their compatibility with maintaining the independence
of EisnerAmper LLP.
Audit
Committee Policy on Pre-Approval of Audit and Permissible Non-Audit Services of Independent Registered Public Accounting Firm
Our
audit committee has established a policy governing our use of the services of our independent registered public accounting firm. Under
this policy, our audit committee is required to pre-approve all audit and non-audit services performed by our independent registered
public accounting firm in order to ensure that the provision of such services does not impair the public accountants’ independence.
All fees paid to EisnerAmper LLP for our fiscal years ended December 31, 2023 and 2022 were pre-approved by our audit committee.
PART IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)(1)
Financial Statements
The financial statements and related notes, together with the report of Bush
& Associates CPA appear at pages F-1 through F-21 following the Exhibit List as required by “Part II-Item 8-Financial Statements
and Supplementary Data” of this Annual Report on Form 10-K.
(a)(2)
Financial Statement Schedules
All
schedules have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements
or notes thereto.
(a)(3)
Exhibits
The
following exhibits are filed as part of, or incorporated by reference into, this Annual Report on Form 10-K.
| Exhibit No. |
|
Description
of Document |
| 3.1
|
|
Amended
and Restated Certificate of Incorporation of Virpax Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.1 to the
Company’s Annual Report on Form 10-K (File No. 001-40064) filed on March 31, 2021). |
| 3.2
|
|
Amended and Restated Bylaws of Virpax Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.2 to the Company’s Annual Report on Form 10-K (File No. 001-40064) filed with the SEC on March 31, 2021). |
| 3.3 |
|
Amendment
to By-Laws dated June 5, 2023 (incorporated by reference to Exhibit 3.1 to Company’s Current Report on Form 8-K (File No.
001-40064) filed with the SEC on June 7, 2023). |
| 3.4 |
|
Certificate
of Amendment to the Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Company’s Current
Report on Form 8-K (File No. 001-40064) filed with the SEC on March 1, 2024) |
| 4.1 |
|
Specimen
Certificate representing shares of common stock of Virpax Pharmaceuticals, Inc. (incorporated by reference to Exhibit 4.1 of the
Company’s Registration Statement on Form S-1 (333-249417) filed with the SEC on October 9, 2020). |
| 4.2 |
|
Form
of Consultant Warrant (incorporated by reference to Exhibit 4.3 of the Company’s Registration Statement on Form S-1
(333-249417) filed with the SEC on October 9, 2020). |
| 4.3 |
|
Form
of Underwriter’s Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S-1/A
(333-249417) filed with the SEC on February 2, 2021). |
| 4.4 |
|
Description of Securities.+ |
| 10.1 |
|
Virpax
Pharmaceuticals, Inc. 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.2 of the Company’s Registration
Statement on Form S-1 (333-249417) filed with the SEC on October 9, 2020) † |
| 10.2 |
|
Form
of Nonqualified Stock Option Award under 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 of the
Company’s Registration Statement on Form S-1 (333-249417) filed with the SEC on October 9, 2020).† |
| 10.3 |
|
Form
of Incentive Stock Option Award under 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.4 of the Company’s
Registration Statement on Form S-1 (333-249417) filed with the SEC on October 9, 2020) † |
| 10.4 |
|
Employment
Agreement by and between Virpax Pharmaceuticals, Inc. and Anthony Mack, dated as of September 18, 2018 (incorporated by reference to
Exhibit 10.5 of the Company’s Registration Statement on Form S-1 (333-249417) filed with the SEC on October 9, 2020)
† |
| 10.5 |
|
Consulting
Agreement by and between Virpax Pharmaceuticals, Inc. and Gerald Bruce, dated as of March 11, 2020 (incorporated by reference to
Exhibit 10.6 of the Company’s Registration Statement on Form S-1 (333-249417) filed with the SEC on October 9,
2020).† |
| 10.6 |
|
Form
of Indemnification Agreement entered into by Virpax Pharmaceuticals, Inc. with its Officers and Directors (incorporated by reference
to Exhibit 10.1 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with the SEC on November 20,
2020). |
| 10.7 |
|
License
Agreement by and between MedPharm Limited and Virpax Pharmaceuticals, Inc., dated as of June 6, 2017 (incorporated by reference to
Exhibit 10.7 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with the SEC on November 20, 2020)
# |
| 10.8 |
|
First
Amendment to the License Agreement by and between MedPharm Limited and Virpax Pharmaceuticals, Inc., dated as of September 2, 2017
(incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with the
SEC on November 20, 2020) # |
| 10.9 |
|
Second
Amendment to the License Agreement by and between MedPharm Limited and Virpax Pharmaceuticals, Inc., dated as of October 31, 2017
(incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with the
SEC on November 20, 2020)# |
| 10.10 |
|
Research
and Option Agreement by and between MedPharm Limited and Virpax Pharmaceuticals, Inc., dated as of April 11, 2017 (incorporated by
reference to Exhibit 10.10 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with the SEC on November
20, 2020). # |
| 10.11 |
|
First
Amendment to the Research and Option Agreement by and between MedPharm Limited and Virpax Pharmaceuticals, Inc., dated as of May 30,
2018 (incorporated by reference to Exhibit 10.11 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with
the SEC on November 20, 2020). # |
| 10.12 |
|
License
and Sublicense Agreement by and between LipoCureRx, Ltd. and Virpax Pharmaceuticals, Inc., dated as of March 19, 2018 (incorporated
by reference to Exhibit 10.12 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with the SEC on
November 20, 2020). # |
| 10.13 |
|
Collaboration
and License Agreement by and between Nanomerics Ltd. and Virpax Pharmaceuticals, Inc., dated as of April 11, 2019 (incorporated by
reference to Exhibit 10.13 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with the SEC on November
20, 2020). # |
| 10.14 |
|
Amendment
to the Collaboration and License Agreement by and between Nanomerics Ltd. and Virpax Pharmaceuticals, Inc., dated as of December 30,
2019 (incorporated by reference to Exhibit 10.14 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with
the SEC on November 20, 2020). # |
| 10.15 |
|
Collaboration
and License Agreement between Nanomerics Ltd. and Virpax Pharmaceuticals, Inc., dated August 7, 2020 (incorporated by reference to
Exhibit 10.17 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with the SEC on February 2, 2021).
# |
| 10.16 |
|
Paycheck
Protection Program Term Note, dated May 4, 2020, between Virpax Pharmaceuticals, Inc. and PNC Bank, National Association.
(incorporated by reference to Exhibit 10.26 of the Company’s Registration Statement on Form S-1 (333-249417) filed with the
SEC on February 2, 2021). |
| 10.17 |
|
Cooperative
Research and Development Agreement, dated August 25, 2020, between the U.S. Department of Health and Human Services, as represented
by National Center for Advancing Translational Sciences an Institute or Center of the National Institutes of Health and Virpax
Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.27 of the Company’s Registration Statement on Form S-1
(333-249417) filed with the SEC on February 2, 2021). |
| 10.18 |
|
Amendment
No. 1 to the Collaboration and License Agreement between Nanomerics Ltd. and Virpax Pharmaceuticals, Inc., dated as of December 31,
2020 (incorporated by reference to Exhibit 10.31 of the Company’s Registration Statement on Form S-1/A (333-249417) filed with
the SEC on February 2, 2021). |
| 10.19 |
|
Employment
Agreement, dated as of April 7, 2021, by and between Christopher M. Chipman and Virpax Pharmaceuticals, Inc. (incorporated by
reference to Exhibit 10.1 of the Company’s current report on Form 8-K (File No. 001-40064) filed with the SEC on April 13,
2021). † |
| 10.20 |
|
Employment
Agreement, dated as of April 15, 2021, by and between Jeffrey Gudin, MD and Virpax Pharmaceuticals, Inc. (incorporated by reference
to Exhibit 10.1 of the Company’s current report on Form 8-K (File No. 001-40064) filed with the SEC on April 19, 2021).
† |
| 10.21 |
|
Amendment
to the Collaboration and License Agreement dated April 11, 2019, as amended, between Nanomerics Ltd. and Virpax Pharmaceuticals,
Inc., dated April 6, 2021 (incorporated by reference to Exhibit 10.3 of the Company’s quarterly report on Form 10-Q (File No.
001-40064) filed with the SEC on August 10, 2021). |
| 10.22 |
|
Amendment
to the Collaboration and License Agreement dated April 11, 2019, as amended, between Nanomerics Ltd. and Virpax Pharmaceuticals
Inc., dated May 5, 2021 (incorporated by reference to Exhibit 10.4 of the Company’s quarterly report on Form 10-Q (File No.
001-40064) filed with the SEC on August 10, 2021). |
| 10.23 |
|
Amendment
No. 1 to the Amended and Restated Virpax Pharmaceuticals, Inc. 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.5
of the Company’s Quarterly Report on Form 10-Q (File No. 001-40064) filed with the SEC on August 10,
2021).† |
| 10.24 |
|
Agreement
for Rendering of Research Services between LipoCureRx, Ltd. and Virpax Pharmaceuticals, Inc., dated June 29, 2021 (incorporated by
reference to Exhibit 10.16 of the Company’s Registration Statement on Form S-1 (File No. 333-259421) filed with the SEC on
September 9, 2021). |
| 10.25 |
|
Virpax
Pharmaceuticals, Inc. 2022 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K (File
No. 001-40064) filed with the SEC on July 25, 2022). |
| 10.26 |
|
Virpax
Pharmaceuticals, Inc. Form of Nonqualified Stock Option Grant Agreement (incorporated by reference to Exhibit 10.2 to the Current
Report on Form 8-K (File No. 001-40064) filed with the SEC on July 25, 2022). |
| 10.27 |
|
Virpax
Pharmaceuticals, Inc. Form of Incentive Stock Option Grant Agreement (incorporated by reference to Exhibit 10.3 to the Current
Report on Form 8-K (File No. 001-40064) filed with the SEC on July 25, 2022). |
| 10.28 |
|
Virpax
Pharmaceuticals, Inc. Form of Restricted Stock Award Agreement (incorporated by reference to Exhibit 10.4 to the Current Report on
Form 8-K (File No. 001-40064) filed with the SEC on July 25, 2022). |
| 10.29 |
|
Virpax
Pharmaceuticals, Inc. Form of Restricted Stock Unit Award Agreement (incorporated by reference to Exhibit 10.5 to the Current Report
on Form 8-K (File No. 001-40064) filed with the SEC on July 25, 2022). |
| 10.30 |
|
Amended
and Restated Collaboration and License Agreement between Nanomerics Ltd. and Virpax Pharmaceuticals, Inc., dated as of March 9,
2022.#+ (incorporated by reference to Exhibit 10.26 of the Annual Report on Form 10-K (File No. 001-40064) filed with the SEC on
March 22, 2023). |
| 10.31 |
|
Amendment No. 1, dated March 29, 2022, to the Employment Agreement by and between Virpax Pharmaceuticals, Inc. and Anthony Mack, dated September 18, 2017.†+ (incorporated by reference to Exhibit 10.7 of the Company’s annual report on Form 10-K (File No. 001-40064) filed with the SEC on March 22, 2023) |
| 10.32 |
|
Amendment No. 1, dated March 29, 2022, to the Employment Agreement by and between Virpax Pharmaceuticals, Inc. and Jeffrey Gudin, MD, dated April 15, 2021.†+ (incorporated by reference to Exhibit 10.11 of the Company’s annual report on Form 10-K (File No. 001-40064) filed with the SEC on March 22, 2023) |
| 10.33 |
|
Employment
Agreement, dated June 20, 2023, by and between Virpax Pharmaceuticals, Inc. and Vinay Shah (incorporated by reference to Exhibit
10.1 to the Current Report on Form 8-K (File No. 001-40064) filed with the SEC on June 21, 2023). |
| 10.34 |
|
Separation
Agreement, dated June 18, 2023, by and between Virpax Pharmaceuticals, Inc. and Christopher Chipman incorporated by reference to
Exhibit 10.2 to the Current Report on Form 8-K (File No. 001-40064) filed with the SEC on June 21, 2023). |
| 10.35 |
|
Amendment
No. 2 to Employment Agreement, dated August 15, 2023, by and between Virpax Pharmaceuticals, Inc. and Anthony Mack (incorporated by
reference to Exhibit 10.1 to the Current Report on Form 8-K (File No. 001-40064) filed with the SEC on August 16,
2023). |
| 10.36 |
|
Employment
Agreement, dated December 6, 2023, by and between Virpax Pharmaceuticals, Inc. and Gerald Bruce (incorporated by reference to
Exhibit 10.1 to the Current Report on Form 8-K (File No. 001-40064) filed with the SEC on December 7, 2023). |
| 10.37 |
|
Settlement Agreement and Mutual Release between Virpax Pharmaceuticals, Inc. and Sorrento Therapeutics, Inc. and Scilex Pharmaceuticals Inc. (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K (File No. 001-40064) filed with the SEC on March 1, 2024) |
| 10.38 |
|
Employment Agreement, dated April 7, 2021, by and between Virpax Pharmaceuticals, Inc. and Sheila Mathias+ |
| 10.39 |
|
Indemnification Agreement, dated March 25, 2024, by and between Virpax Pharmaceuticals, Inc. and Vinay Shah+ |
| 19.1 |
|
Insider Trading Policy+ |
| 21.1 |
|
List of Subsidiaries+ |
| 23.1 |
|
Consent of Bush & Associates CPA, Independent Registered Public Accounting Firm for the financial statements of Virpax Pharmaceuticals, Inc.* |
| 31.1 |
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a)* |
| 31.2 |
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a)* |
| 32.1 |
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350** |
| 32.2 |
|
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350** |
| 97.1 |
|
Clawback Policy+ |
| 101.INS* |
|
Inline
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within
the Inline XBRL document |
| 101.SCH* |
|
Inline
XBRL Taxonomy Extension Schema Document |
| 101.CAL* |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document |
| 101.DEF* |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document |
| 101.LAB* |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document |
| 101.PRE* |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document |
| 104* |
|
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
| + |
Previously filed. |
| * |
Filed
herewith. |
| ** |
Furnished,
not filed. |
| † |
Denotes
management compensation plan or contract. |
| # |
Certain
portions of this exhibit have been omitted because the omitted information is (i) not material and (ii) would likely
cause competitive harm to the Company if publicly disclosed. |
ITEM
16. FORM 10-K SUMMARY
None.
SIGNATURES
Pursuant
to the requirements of Section 13 and 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report
to be signed on its behalf by the undersigned thereunto duly authorized.
| |
VIRPAX PHARMACEUTICALS, INC. |
| |
(Registrant) |
| |
|
| Date: October 10, 2024 |
/s/ Jatinder Dhaliwal |
| |
Jatinder Dhaliwal |
| |
Chief Executive Officer |
| |
(Principal Executive and Financial Officer) |
| |
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on
behalf of the registrant and in the capacities and on the dates indicated.
| Signature |
|
Title |
|
Date |
| |
|
|
|
|
| /s/ Jatinder Dhaliwal |
|
Chief Executive Officer and Director |
|
October 10, 2024 |
| Jatinder Dhaliwal |
|
(Principal Executive and Financial Officer) |
|
|
| |
|
|
|
|
| /s/ Katharyn Field |
|
Vice President, Director |
|
October 10, 2024 |
| Katharyn Field |
|
|
|
|
| |
|
|
|
|
| /s/ Gary Herman |
|
Director |
|
October 10, 2024 |
| Gary Herman |
|
|
|
|
| |
|
|
|
|
| /s/ Judy Su |
|
Director |
|
October 10, 2024 |
| Judy Su |
|
|
|
|
VIRPAX
PHARMACEUTICALS, INC
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Report
of Independent Registered Public Accounting Firm
To the Board of Directors and the Stockholders of
Virpax Pharmaceuticals, Inc.
OPINION ON THE CONSOLIDATED FINANCIAL STATEMENTS
We have audited the accompanying consolidated balance sheet of Virpax Pharmaceuticals,
Inc. (the “Company”) as of December 31, 2023, and 2022, and the related consolidated statements of operations and comprehensive
loss, stockholders’ equity and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial
position of the Company as of December 31, 2023, and 2022, and the results of its operations and its cash flows for the years then ended
in conformity with accounting principles generally accepted in the United States of America.
GOING CONCERN
The accompanying consolidated financial statements have been prepared assuming
that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred
continuing losses and has obligations for significant cash payments in the next year that raise substantial doubt about its ability to
continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
BASIS FOR OPINION
These consolidated financial statements are the responsibility of the Company's
management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit. We are a public
accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to
be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations
of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated 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 audit included performing procedures to assess the risks of material
misstatement of the consolidated 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 consolidated 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 consolidated financial statements. We believe that our audit provides a reasonable basis for
our opinion.
CRITICAL AUDIT MATTERS
Critical audit matters are matters arising from the current period audit
of the consolidated 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
judgements. We determined that there are no critical audit matters.
/s/ Bush & Associates CPA LLC
We have served as the Company’s auditor since 2024.
Henderson, Nevada
October 4, 2024
PCAOB ID Number 6797
VIRPAX
Pharmaceuticals, Inc.
CONSOLIDATED
BALANCE SHEETS
| | |
December 31,
2023 | | |
December 31,
2022 | |
| ASSETS | |
| | |
| |
| Current assets | |
| | |
| |
| Cash | |
$ | 9,141,512 | | |
$ | 18,995,284 | |
| Prepaid expenses and other current assets | |
| 486,833 | | |
| 678,365 | |
| Total current assets | |
| 9,628,345 | | |
| 19,673,649 | |
| Total assets | |
$ | 9,628,345 | | |
$ | 19,673,649 | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable and accrued expenses | |
$ | 1,694,024 | | |
$ | 1,094,590 | |
| Litigation liability | |
| 6,000,000 | | |
| 2,000,000 | |
| Total current liabilities | |
| 7,694,024 | | |
| 3,094,590 | |
| Total liabilities | |
| 7,694,024 | | |
| 3,094,590 | |
| | |
| | | |
| | |
| Commitments and contingencies | |
| | | |
| | |
| | |
| | | |
| | |
| Stockholders’ equity | |
| | | |
| | |
| Preferred stock, par value $0.00001, 10,000,000 shares authorized; no shares issued and outstanding as of the years ended December 31, 2023 and 2022 | |
| — | | |
| — | |
| Common stock, $0.00001 par value; 100,000,000 shares authorized, 1,171,233 shares issued and outstanding as of the years ended December 31, 2023 and 2022 | |
| 12 | | |
| 12 | |
| Additional paid-in capital | |
| 61,478,444 | | |
| 60,933,674 | |
| Accumulated deficit | |
| (59,544,135 | ) | |
| (44,354,627 | ) |
| Total stockholders’ equity | |
| 1,934,321 | | |
| 16,579,059 | |
| Total liabilities and stockholders’ equity | |
$ | 9,628,345 | | |
$ | 19,673,649 | |
See
Notes to the Consolidated Financial Statements
VIRPAX
Pharmaceuticals, Inc.
CONSOLIDATED
STATEMENTS OF OPERATIONS
| |
|
For the Year Ended
December 31, |
|
| |
|
2023 |
|
|
2022 |
|
| OPERATING EXPENSES |
|
|
|
|
|
|
| General and administrative (net of insurance reimbursement of $1,250,000 during the year ended December 31, 2023 – See Note 5) |
|
$ |
10,572,181 |
|
|
$ |
11,082,463 |
|
| Research and development |
|
|
5,117,608 |
|
|
|
10,762,670 |
|
| Total operating expenses |
|
|
15,689,789 |
|
|
|
21,845,133 |
|
| |
|
|
|
|
|
|
|
|
| Loss from operations |
|
|
(15,689,789 |
) |
|
|
(21,845,133 |
) |
| |
|
|
|
|
|
|
|
|
| OTHER INCOME |
|
|
|
|
|
|
|
|
| Other income |
|
|
500,281 |
|
|
|
194,413 |
|
| Loss before income taxes |
|
|
(15,189,508 |
) |
|
|
(21,650,720 |
) |
| Income taxes |
|
|
— |
|
|
|
— |
|
| Net loss |
|
$ |
(15,189,508 |
) |
|
$ |
(21,650,720 |
) |
| |
|
|
|
|
|
|
|
|
| Basic and diluted net loss per share |
|
$ |
(12.97 |
) |
|
$ |
(18.49 |
) |
| Basic and diluted weighted average common stock outstanding |
|
|
1,171,233 |
|
|
|
1,171,020 |
|
See
Notes to the Consolidated Financial Statements
VIRPAX
Pharmaceuticals, Inc.
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
| |
|
Common stock |
|
|
Additional
paid-in |
|
|
Accumulated |
|
|
Total
stockholders’ |
|
| |
|
Shares |
|
|
Amount |
|
|
capital |
|
|
deficit |
|
|
equity |
|
| Balance at December 31, 2021 |
|
|
1,171,293 |
|
|
$ |
12 |
|
|
$ |
60,188,640 |
|
|
$ |
(22,703,907 |
) |
|
$ |
37,484,745 |
|
| Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
745,034 |
|
|
|
— |
|
|
|
745,034 |
|
| Restricted stock awards forfeited |
|
|
(60 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
| Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(21,650,720 |
) |
|
|
(21,650,720 |
) |
| Balance at December 31, 2022 |
|
|
1,171,233 |
|
|
|
12 |
|
|
|
60,933,674 |
|
|
|
(44,354,627 |
) |
|
|
16,579,059 |
|
| Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
544,770 |
|
|
|
— |
|
|
|
544,770 |
|
| Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(15,189,508 |
) |
|
|
(15,189,508 |
) |
| Balance at December 31, 2023 |
|
|
1,171,233 |
|
|
$ |
12 |
|
|
$ |
61,478,444 |
|
|
$ |
(59,544,135 |
) |
|
$ |
1,934,321 |
|
See
Notes to the Consolidated Financial Statements
VIRPAX
Pharmaceuticals, Inc.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
| |
|
For the Year Ended
December 31, |
|
| |
|
2023 |
|
|
2022 |
|
| CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
| Net loss |
|
$ |
(15,189,508 |
) |
|
$ |
(21,650,720 |
) |
| Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
| Stock-based compensation |
|
|
544,770 |
|
|
|
745,034 |
|
| Change in operating assets and liabilities: |
|
|
|
|
|
|
|
|
| Prepaid expenses and other current assets |
|
|
191,532 |
|
|
|
2,052,079 |
|
| Accounts payable and accrued expenses |
|
|
599,434 |
|
|
|
(993,101 |
) |
| Litigation liability |
|
|
4,000,000 |
|
|
|
2,000,000 |
|
| Net cash used in operating activities |
|
|
(9,853,772 |
) |
|
|
(17,846,708 |
) |
| |
|
|
|
|
|
|
|
|
| Net change in cash |
|
|
(9,853,772 |
) |
|
|
(17,846,708 |
) |
| Cash, beginning of year |
|
|
18,995,284 |
|
|
|
36,841,992 |
|
| Cash, end of year |
|
$ |
9,141,512 |
|
|
$ |
18,995,284 |
|
See
Notes to the Consolidated Financial Statements
VIRPAX
Pharmaceuticals, Inc.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note
1. Business, and Liquidity and Going Concern
Business
Virpax
Pharmaceuticals, Inc. (“Virpax” or the “Company”) was incorporated on May 12, 2017 in the state of Delaware.
Virpax is a preclinical stage pharmaceutical company focused on developing novel and proprietary drug-delivery systems, and drug-releasing
technologies focused on advancing non-opioid and non-addictive pain management treatments and treatments for central nervous system (“CNS”)
disorders to enhance patients’ quality of life.
On July 26, 2023, the Company formed Novvae Pharmaceuticals,
Inc., a wholly owned subsidiary of the Company, in the state of Delaware, for the purpose of developing over the counter products. No
activities have occurred during the year ended December 31, 2023.
Liquidity
and Going Concern
The
Company, since inception, has been engaged in organizational activities, including raising capital and research and development activities.
The Company has not generated revenues and has not yet achieved profitable operations, nor has it ever generated positive cash flow from
operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. The Company is subject
to those risks associated with any preclinical stage pharmaceutical company that has substantial expenditures for research and development.
There can be no assurance that the Company’s research and development projects will be successful, that products developed will
obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in
an environment of rapid technological change and is largely dependent on the services of its employees and consultants. Further, the
Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital.
The
Company incurred a net loss of $15,189,508 and $21,650,720 for the years ended December 31, 2023 and 2022, respectively, and had an accumulated
deficit of $59,544,135 as of December 31, 2023. The Company anticipates incurring additional losses until such time, if ever, that it
can generate significant revenue from its product candidates currently in development. The Company’s primary source of capital
has been the issuance of debt and equity securities.
As noted in Note 5. Commitments and Contingencies,
the Company has paid $3.5 million to the Plaintiffs on the Effective Date pursuant to the terms of the Settlement Agreement and is obligated
to pay an additional $2.5 million to the Plaintiffs on July 1, 2024. The Company will need to raise additional capital to fund operations,
make the $2.5 million payment, and, in addition, fund other required payments, if any, to its former Chief Executive Officer. Due to
the Company’s continuing losses and cash position, there exists substantial doubt about the Company’s ability to continue
as a going concern. The accompanying financial statements do not include any adjustments to the carrying amounts and classification of
assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.
Additional
financings will be needed by the Company to fund its operations, including litigation costs, and to complete clinical development of
and to commercially develop all of its product candidates. There is no assurance that such financing will be available when needed or
on acceptable terms. The Company also may be forced to curtail spending in research and development activities in order to conserve cash.
Note
2. Summary of Significant Accounting Policies
Basis
of Presentation — The accompanying financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”) and reflect the operations of the Company. Any reference
in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”)
and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Use
of Estimates — The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and liabilities,
at the date of the financial statements, and the reported amounts of expenses during the reporting period. Due to the uncertainty of
factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary
from these estimates.
Significant
items subject to such estimates and assumptions include research and development accruals and prepaid expenses, estimated litigation
liability, and the valuation of stock-based compensation. It is at least reasonably possible that the estimate of the effect of a condition,
situation or set of circumstances that existed at the date of the financial statements, which management considered in formulating its
estimate, could change in the near term due to one or more future confirming events. Accordingly, the actual results could differ from
those estimates. Accounting estimates used in the preparation of these financial statements change as new events occur, as more experience
is acquired, as additional information is obtained and as the operating environment changes.
Basic
and Diluted Loss per Share — Basic net loss per share is determined using the weighted average number of shares of
common stock outstanding during each period. Diluted net loss per share includes the effect, if any, from the potential exercise or conversion
of securities, such as stock options and warrants, which would result in the issuance of incremental shares of common stock. The computation
of diluted net loss per shares does not include the conversion of securities that would have an antidilutive effect. Equivalent common
shares are excluded from the calculation of diluted net loss per share since their effect is antidilutive due to the net loss of the
Company which consisted of the following:
| |
|
Year Ended December 31, |
|
| |
|
2023 |
|
|
2022 |
|
| Equivalent common shares |
|
|
|
|
|
|
| Stock options |
|
|
175,686 |
|
|
|
117,228 |
|
| Warrants |
|
|
1,843 |
|
|
|
1,843 |
|
| Unvested restricted stock awards |
|
|
— |
|
|
|
23 |
|
Cash —
At times, The Company deposits its cash with reputable financial institutions that are insured by the Federal Deposit Insurance
Corporation (“FDIC”). At times, the Company’s cash balances exceed the insured amounts provided by the FDIC. The
Company’s cash balances exceeded federally insured limits by approximately $8,900,000 and $18,700,000 as of December 31, 2023
and December 31, 2022, respectively.
Fair
Value of Financial Instruments — The carrying amounts of the Company’s financial instruments, including cash
and accounts payable approximate fair value due to the short-term nature of those instruments.
Research
and Development — Research and development costs are expensed as incurred. These expenses include the costs of proprietary
efforts, as well as costs incurred in connection with certain licensing arrangements and external research and development expenses incurred
under arrangements with third parties, such as contract research organizations (“CROs”) and consultants. At the end of each
reporting period, the Company compares the payments made to each service provider to the estimated progress towards completion of the
related project. Factors that the Company considers in preparing these estimates include the status of preclinical studies, milestones
achieved, and other criteria related to the efforts of its vendors. These estimates will be subject to change as additional information
becomes available.
Stock-based
Compensation — Stock-based compensation cost is measured at the grant date based on the fair value of the award and
is recognized as expense over the requisite service period, which is generally the vesting period. The Company’s policy permits
the valuation of stock-based awards granted to non-employees to be measured at fair value at the grant date and records forfeitures as
they occur.
Determining
the appropriate fair value of share-based awards requires the use of subjective assumptions, including the fair value of the Company’s
common shares prior to its initial public offering, and for options, the expected life of the option and expected share price volatility.
The Company uses the Black-Scholes option pricing model to value its option awards. The assumptions used in calculating the fair value
of share-based awards represents management’s best estimates and involve inherent uncertainties and the application of management’s
judgment. As a result, if factors change and management uses different assumptions, share-based compensation expense could be materially
different for future awards.
The
expected life of options was estimated using the simplified method, as the Company has no historical information to develop reasonable
expectations about future exercise patterns and post-vesting employment.
Income
Taxes — The Company accounts for income taxes using the asset-and-liability method in accordance with ASC 740, Income
Taxes (“ASC 740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences
between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss
and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income
in the years in which those temporary differences are expected to be recovered or settled. The effect on the deferred tax assets and
liabilities of a change in tax rate is recognized in the period that includes the enactment date. A valuation allowance is recorded if
it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized in future periods.
The
Company follows the guidance in ASC 740-10 in assessing uncertain tax positions. The standard applies to all tax positions and clarifies
the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement. The
first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical
merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely than-not threshold
are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the
taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that
the position is more likely than not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties
related to tax positions in income tax expense. As of December 31, 2023, the Company had no uncertain income tax positions.
Note
3. Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consist of the following:
| | |
December 31,
2023 | | |
December 31,
2022 | |
| Prepaid insurance | |
$ | 136,241 | | |
$ | 156,754 | |
| Prepaid research and development | |
| 283,370 | | |
| 496,270 | |
| Other prepaid expenses and current assets | |
| 67,222 | | |
| 25,341 | |
| | |
$ | 486,833 | | |
$ | 678,365 | |
Note
4. Accounts Payable and Accrued Liabilities
Accounts
payable and accrued liabilities consists of the following:
| |
|
December 31,
2023 |
|
|
December 31,
2022 |
|
| Accrued payroll |
|
$ |
493,780 |
|
|
$ |
654,765 |
|
| Estimated separation expense |
|
|
711,000 |
|
|
|
— |
|
| Research and development expenses |
|
|
143,071 |
|
|
|
254,904 |
|
| Legal expenses |
|
|
97,089 |
|
|
|
147,277 |
|
| Professional fees |
|
|
230,627 |
|
|
|
— |
|
| Other |
|
|
18,457 |
|
|
|
37,644 |
|
| |
|
$ |
1,694,024 |
|
|
$ |
1,094,590 |
|
Note
5. Commitments and Contingencies
Litigation
From
time to time the Company is subject to claims by third parties under various legal disputes. The defense of such claims, or any adverse
outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, financial condition and cash
flows.
On
March 12, 2021, the Company and its former Chief Executive Officer, Anthony P. Mack (together, the “Defendants”), were named
as defendants in a complaint (the “Complaint”) filed by Sorrento Therapeutics, Inc. (“Sorrento”), and Scilex
Pharmaceuticals Inc. (“Scilex” and together with Sorrento, the “Plaintiffs”) in the Court of Chancery of the
State of Delaware captioned Sorrento Therapeutics, Inc. and Scilex Pharmaceuticals Inc. v. Anthony Mack and Virpax Pharmaceuticals,
Inc., Case No. 2021-0210-PAF (the “Action”). In the Complaint, Plaintiffs alleged (i) Mr. Mack breached a Restrictive
Covenants Agreement, dated as of November 8, 2016, between himself and Sorrento (the “Restrictive Covenants Agreement”),
(ii) the Company tortiously interfered with the Restrictive Covenants Agreement, and (iii) the Company tortiously interfered with Scilex’s
relationship with Mr. Mack. On May 7, 2021, Plaintiffs filed an Amended Complaint asserting the same three causes of action. On September
28, 2021, Plaintiffs filed a Second Amended Complaint asserting the same three causes of action as the prior complaints, as well as claims
in which Plaintiffs alleged (i) Mr. Mack breached an Employment, Proprietary Information and Inventions Agreement, dated as of October
25, 2016, between himself and Sorrento (the “Employment Agreement”), (ii) the Company tortiously interfered with the Employment
Agreement, (iii) Mr. Mack breached his fiduciary duties to Scilex, and (iv) the Company aided and abetted Mr. Mack’s alleged breach
of fiduciary duties to Scilex. On April 1, 2022, Plaintiffs filed a Third Amended Complaint. The Third Amended Complaint asserts the
same causes of action as the Second Amended Complaint, as well as claims for (i) misappropriation of trade secrets by Defendants under
Delaware law, and (ii) misappropriation of trade secrets by Defendants under California law. On April 18, 2022, Defendants filed answers
to the Third Amended Complaint. Trial was held before Vice Chancellor Paul Fiorvanti from September 12 through September 14, 2022.
In
March 2023, the Company collected $1,250,000 in reimbursement of legal costs pursuant to the Company’s directors’ and officers’
insurance policy, and recorded it as a reduction of general and administrative expense on the consolidated statements of operations.
No further reimbursements are permitted from the insurance policy with respect to the litigation.
On
September 1, 2023, the Chancery Court issued a memorandum opinion addressing liability in the Action and found in favor of Plaintiffs
on all but three counts, which the Court found were waived. The Chancery Court found it proper to attribute Mr. Mack’s knowledge
and actions to the Company, which Mr. Mack used to effectuate the tortious interference and breach of fiduciary duty. The Chancery Court
found that Mr. Mack breached the Restrictive Covenants Agreement he entered into with Sorrento by developing EpoladermTM;
the Company is liable for tortious interference with contract; Plaintiffs were deemed to have waived their claims for breach of Mr. Mack’s
Employment Agreement and for tortious interference with prospective economic advantage; Mr. Mack breached his fiduciary duty of loyalty
to Scilex; the Company aided and abetted Mr. Mack’s breach of fiduciary duty; and Mr. Mack misappropriated certain Scilex trade
secrets. The Court, however, stated that the question of an appropriate remedy must await further briefing.
On
October 18, 2023, in accordance with the Chancery Court’s supplemental briefing schedule, Plaintiffs filed their supplemental brief
requesting the following relief: an injunction, in the first instance, enjoining Mr. Mack from having any relationship with Virpax for
a period of 18 months and 27 days; enjoining Virpax from further developing or marketing Epoladerm for a period of 18 months and 27 days;
alternatively, if these two injunction requests were not granted, Plaintiffs requested a judgement of joint and several liability against
Mr. Mack and Virpax of $14,684,833. In addition to these requests for injunctive relief (or in, the alternative, damages), Plaintiffs
sought a constructive trust over the revenues of Epoladerm, ProbudurTM and EnveltaTM, or, in the alternative to
a constructive trust, a royalty of 5 per cent of net sales of Epoladerm, 8-11 percent of net sales of Probudur and 7.5 percent of net
sales of Envelta. In addition to the requests for injunctive relief, imposition of a constructive trust and/or royalties, Plaintiffs
also requested additional damages, jointly and severally, against Mr. Mack and Virpax as follows: $1.3 million for misuse of Scilex resources,
$6.7 million for misappropriation of trade secrets, $13.4 million for exemplary damage (trade secrets damage x2) and attorney’s
fees in an unspecified amount. Finally, Plaintiffs sought injunctive relief, enjoining Mr. Mack and Virpax from further accessing Scilex’s
trade secrets; requiring Mr. Mack and Virpax to return Scilex’s trade secrets to Plaintiffs; and enjoining Mr. Mack and Virpax
from marketing or selling any products derived from or incorporating Scilex’s trade secrets.
On
November 29, 2023, in accordance with the Chancery Court’s supplemental briefing schedule, Defendants filed their supplement brief
on damages rebutting Plaintiffs’ damages analysis. Throughout the brief, Defendants argued Plaintiffs failed to meet their burden
to prove damages, and as such, should be precluded from any damages award. However, given the Court’s instruction, Defendants proffered
a reasonable damages analysis as follows. As for the injunctive relief requested against Mr. Mack, the Company took no position, as the
request was directed to Mr. Mack personally. Concerning Plaintiffs’ request for an injunction against further development of Epoladerm
for a period of 18 months and 27 days, Defendants opposed this request, arguing lack of irreparable harm, given Plaintiffs’ request
for money damages. Defendants also argued a constructive trust is inappropriate, given Plaintiffs failed to articulate the parameters
of such relief and, additionally, the lack of sales for the drug candidates preclude such relief. In terms of the money damages related
to the three drug candidates, Defendants proffered a reasonable royalty rate of 1-3% of the net profits of the drug candidates, as opposed
to lump sum damages, as such rate would alleviate the speculative nature of the damages requested by Plaintiffs. As for the misappropriation
of trade secrets request of $6.7 million, given the Court found only 5 of the proffered 1,182 documents were trade secrets, Defendants
contend Plaintiffs should receive no monetary damages (given the reasonable royalty would encompass use of these documents and, alternatively,
Defendants would return such documents). However, if the Court were to award damages, such damages should be pro rata for the documents,
or roughly $28,382. And, finally, Defendants opposed the request for attorneys’ fees and exemplary damages.
On
December 21, 2023, Plaintiffs filed their reply brief on damages, generally reasserting their prior arguments on damages and rebutting
Defendants’ arguments. Plaintiffs also asserted they supported their damages claims with sufficient evidence.
On February 29, 2024, Plaintiffs and the Company
entered into a Settlement Agreement and Mutual Release (the “Settlement Agreement”) to fully resolve all issues related to
settlement of the litigation with Plaintiffs, subject to the entry by the United States Bankruptcy Court for the Southern District of
Texas, which is handling the Sorrento bankruptcy filing (the “Bankruptcy Court”), of an order approving the Settlement Agreement
(the “Settlement Order”). On March 1, 2024, the Plaintiffs filed a motion to approve the Settlement Agreement and grant the
related relief with the Bankruptcy Court. On March 14, 2024, the Bankruptcy Court entered an order approving the Settlement Agreement
and on March 20th the Plaintiffs filed a Stipulation of Dismissal with the Chancery Court dismissing the Action.
As settlement consideration, the Company agreed
to pay Sorrento and Scilex a total cash payment of $6 million, of which $3.5 million was be paid two business days after the Effective
Date, March 18, 2024, and the remaining $2.5 million is to be paid on or before July 1, 2024. The Effective Date is defined as the date
the Settlement Order is entered into if there are no objections to Sorrento’s motion for approval of the Settlement Agreement; or
the date the Settlement Order becomes non-appealable if there are objections to Sorrento’s motion for approval of the Settlement
Agreement. Additionally, the Company agreed to pay to Plaintiffs royalties of 6% of annual net sales of products developed from drug candidates
Epoladerm, Probudur and Envelta until the earlier of the expiration of the last-to-expire valid patent claim of such product and the expiration
of any period of regulatory exclusivity for such product.
The Plaintiffs can still pursue claims against
Mr. Mack. The Company’s Amended and Restated Bylaws dated November 18, 2020 (“Bylaws”) require the Company to “indemnify
any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding,
whether civil, criminal, administrative or investigative (other than an action by or in the right of the Corporation) by reason of the
fact that such person is or was a director or officer of the Corporation, or, while a director or officer of the Corporation….”
Such indemnification, however, is limited to circumstances where the covered person “acted in good faith and in a manner such person
reasonably believed to be in or not opposed to the best interests of the Corporation….” Mr. Mack may attempt to claim
he is entitled to indemnification, should the Court find him liable for damages in the Action. Given the findings in the Memorandum
Opinion issued in the Action, the Company believes it has a strong position that Mr. Mack would not be entitled to indemnification.
There is a risk, however, that a Court could find he is entitled to such indemnification and any such award may be material. Additionally,
per Section 7.6 of the Bylaws, the Company has been advancing Mr. Mack’s attorneys’ fees and costs for the Action. It
is likely Mr. Mack will contend he is still entitled to advancement of any fees and/or costs for the Action going forward and may seek
judicial intervention. However, as per the Bylaws, Mr. Mack is only entitled to advancement of expenses for indemnifiable actions.
As noted above, given the Memorandum Opinion in the Action, the Company believes that it has a strong position that Mr. Mack is not entitled
to indemnification, and therefore, not entitled to advancement of expenses. However, there is a risk that a Court could find that Mr.
Mack is entitled to such advancement and such amounts may be material. Further, Mr. Mack may attempt to seek damages from the Company
based on the Court’s final judgment on damages under the theory of joint and several liability and seek contribution from the Company
for any monetary judgment and such amounts may be material.
The Court is aware that Plaintiffs have settled
with the Company and that the Settlement Agreement fully releases the Company from any claims or damages, the Plaintiff has against the
Company, related to the Action. Given the Settlement Agreement does not release Mr. Mack from liability related to the Action, the Court
has requested supplemental briefing as to whether the Court can dismiss the Company from the lawsuit, as well as any claims Mr. Mack has
against the Company arising from the Action. While the Company believes that any damages assessed may be awarded against Mr. Mack alone,
Plaintiffs cannot seek additional damages from Virpax. However, there is a risk that Mr. Mack will still seek contribution from the Company
for any damages claim arising from the Action. And, there is a risk that the Court will rule in Mr. Mack’s favor and such amounts
may be material.
As
of December 31, 2022, the Company had accrued $2.0 million with respect to the litigation. Based on the facts of the litigation and the
Settlement Agreement, the Company has recognized an accrual totaling $6.0 million with respect to the litigation as of December 31, 2023.
The Company recognized $4.0 million and $2.0 million for the years ended December 31, 2023 and 2022, respectively, included in general
and administrative expenses on the consolidated statements of operations.
Anthony Mack Resignation
On
November 15, 2023, the Company accepted the resignation of Anthony P. Mack as Chief Executive Officer (“CEO”) and Chair of
the Board of Directors (the “Board”) of the Company effective November 17, 2023. The resignation was not related to any disagreement
with the Company on any matter relating to its operations, policies or practices. The Company is negotiating a separation agreement
with Mr. Mack and has recorded estimated separation compensation expense related to the separation agreement of $711,000 and included
in general and administrative expenses for the year ended December 31, 2023 and in accounts payable and accrued expenses as of December
31, 2023 . While the Company believes this estimated expense related
to the separation agreement to be reasonably possible, actual results may materially vary from these estimates. As part of the consideration
for the separation agreement, Mr. Mack will be expected to release, discharge and waive any rights to indemnification, and/or contribution
related to the Action. The accrual does not include any amounts that we may be required to pay for
indemnification claims or contribution that he may seek against us.
Global
Macroeconomic Environment
The global macroeconomic environment could be
negatively affected by, among other things, resurgence of COVID-19 or other pandemics or epidemics, instability in global economic markets,
increased U.S. trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain weaknesses,
instability in the geopolitical environment as a result of the withdrawal of the United Kingdom from the European Union, the Russian
invasion of the Ukraine , the war in the Middle East, other political tensions, and foreign governmental debt concerns. Such challenges
have caused, and may continue to cause, uncertainty and instability in local economies and in global financial markets. As a result,
the Company and its third party CMOs, and CROs have and may in the future face disruptions in procuring items that are essential to the
Company’s research and development activities, including, for example, medical and laboratory supplies used in the Company’s
preclinical studies that are sourced from abroad or for which there are shortages, or potential difficulties recruiting patients, and
may cause delays and difficulties with ongoing and planned preclinical and clinical trials. The extent to which the Company’s financial
condition, liquidity or results of operations are impacted is uncertain, and may negatively impact the Company’s results of operations,
financial condition, and liquidity in 2023 and potentially beyond.
Note
6. Stockholders’ Equity
Overview
Preferred
Stock
The
Company’s Certificate of Incorporation, filed on May 12, 2017, and amended and restated on February 16, 2021, authorizes the issuance
of preferred stock. The total number of shares which the Company is authorized to issue is 10,000,000, with a par value of $0.00001 per
share.
Common
Stock
The Company’s Certificate of Incorporation, filed on May 12,
2017, and amended and restated on February 16, 2021, authorizes the issuance of common stock. The total number of shares which the Company
is authorized to issue is 100,000,000, with a par value of $0.00001 per share. As of December 31, 2023 and 2022 there were 1,171,233 common
shares issued or outstanding.
On
February 29, 2024, the Company filed a certificate of amendment to the Company’s Amended and Restated Certificate of Incorporation
for purposes of effecting a 1-for-10 reverse stock split (the “Reverse Split”) of the Company’s outstanding shares
of common stock such that, effective upon March 1, 2024, the day after the filing thereof, every 10 issued and outstanding shares of
the Company’s common stock were subdivided and reclassified into one validly issued, fully paid and non-assessable share of
the Company’s common stock.
All share and per share amounts in the consolidated
financial statements have been retroactively adjusted for all periods presented to give effect to the Reverse Split, including reclassifying
$105 equal to the reduction in par value to additional paid-in capital.
The
Reverse Split affected all issued and outstanding shares of Common Stock, as well as Common Stock underlying stock options and warrants
outstanding immediately prior to the effectiveness of the Reverse Split.
Warrants
There were warrants exercisable for 1,843 shares
of the Company’s common stock outstanding as of December 31, 2023 and 2022. There were no warrants granted, exercised, or forfeited
during the years ended December 31, 2023 and 2022. Warrants exercisable for 505 shares have an exercise price of $98.89 with expiration
date of September 22, 2030. Warrants exercisable for 1,338 shares have an exercise price of $125.00 with an expiration date of February
16, 2026.
Note
7. Stock-Based Compensation
On
May 20, 2017, the Company established the Virpax Pharmaceuticals, Inc. Amended and Restated 2017 Equity Incentive Plan (the “2017
Plan”). The Company’s Board of Directors (the “Board”), acting through its Equity Incentive Plan Committee, has
determined that it would be to the advantage and best interest of the Company and its stockholders to grant restricted stock awards to
certain individuals as compensation to serve as an employee of the Company and as an incentive for increased efforts during such service.
On June 14, 2022, the Company established the
Virpax Pharmaceuticals, Inc. 2022 Equity Incentive Plan (the “2022 Plan”) and no new grants of awards will be made under
the 2017 Plan and all new grants of awards will be made under the 2022 Plan. The 2022 Plan and 2017 Plan are administered by the Compensation
Committee of the Board (the “Compensation Committee”); provided that the entire Board may act in lieu of the Compensation
Committee on any matter. The 2022 Plan enables the Company to continue to provide equity and equity-based awards to eligible employees,
officers, non-employee directors and other individual service providers by reserving 150,000 shares of the Company’s common stock
for issuance under the 2022 Plan, as adjusted per the Reverse Split, subject to a 2% annual increase (similar to the 2017 Plan) pursuant
to an “evergreen” provision in the 2022 Plan (discussed further below). The Company believes that offering ownership interests
in the Company is a key factor in retaining and recruiting employees, officers, non-employee directors and other individual service providers,
and aligning and increasing their interests in the Company’s success.
The
2022 Plan (which is summarized below) is substantially similar to the 2017 Plan, except for (i) the increase in shares of common stock
reserved for issuance as discussed above, and (ii) the elimination of annual limitations on grants of awards to eligible individuals
and certain other provisions which had been included in the 2017 Plan in order to satisfy (now repealed) provisions of Section 162(m)
of the Internal Revenue Code of 1986, as amended.
The
2022 Plan reserves an aggregate of (i) 150,000 shares of the Company’s common stock for the issuance of awards under the 2022 Plan
(all of which may be granted as an Incentive Stock Option, or ISOs) plus (ii) an additional number of shares of common stock subject
to outstanding awards under the 2017 Plan that become forfeited or canceled without payment or which are surrendered in payment of the
exercise price and/or withholding taxes (collectively, the “Share Limit”). Pursuant to the 2022 Plan’s “evergreen”
provision, the Share Limit shall be cumulatively increased on January 1, 2023, and on each January 1 thereafter, by 2% of the number
of shares of common stock issued and outstanding on the immediately preceding December 31 or such lesser number of shares as determined
by the Board. The 2022 Plan increased by 23,428 shares on January 1, 2023.
In
applying the aggregate share limitation under the 2022 Plan, shares of common stock (i) subject to awards that are forfeited, cancelled,
returned to the Company for failure to satisfy vesting requirements or otherwise forfeited, or terminated without payment being made
thereunder and (ii) that are surrendered in payment or partial payment of the exercise price of an option or stock appreciation right
or taxes required to be withheld with respect to the exercise of Stock Options or stock appreciation rights or in payment with respect
to any other form of award are not counted and, therefore, may be made subject to new awards under the 2022 Plan. There are 116,511 shares
available for future grant under the 2022 Plan at December 31, 2023.
Total
stock based compensation, inclusive of restricted shares and stock options, consists of the following:
| | |
For the Year Ended
December 31, | |
| | |
2023 | | |
2022 | |
| General and administrative expense | |
$ | 335,363 | | |
$ | 598,655 | |
| Research and development expense | |
| 209,407 | | |
| 146,379 | |
| | |
$ | 544,770 | | |
$ | 745,034 | |
The
fair value of option awards is estimated using the Black-Scholes option-pricing model. Exercise price of each award is generally not
less than the per share fair value in effect as of that award date. The determination of fair value using the Black-Scholes model is
affected by the Company’s share fair value as well as assumptions regarding a number of complex and subjective variables, including
expected price volatility, risk-free interest rate and projected employee share option exercise behaviors. Options granted or modified
under the 2017 and 2022 Plans during the years ended December 31, 2023 and 2022 were valued using the Black-Scholes option-pricing model
with the following weighted-average assumptions:
| | |
For the Year Ended
December 31, | |
| | |
2023 | | |
2022 | |
| Expected term (years) | |
| 5.46 | | |
| 5.65 | |
| Risk-free interest rate | |
| 3.67 | % | |
| 1.96 | % |
| Expected volatility | |
| 113.12 | % | |
| 77.12 | % |
| Expected dividend yield | |
| 0 | % | |
| 0 | % |
The
Company estimates its expected volatility by using a combination of historical share price volatilities of similar companies within our
industry. The risk-free interest rate assumption is based on observed interest rates for the appropriate term of the Company’s
options on a grant date. The expected option term assumption is estimated using the simplified method and is based on the mid-point between
vest date and the remaining contractual term of the option, since the Company does not have sufficient exercise history to estimate expected
term of its historical option awards.
2017
Plan
Restricted stock
As of December 31, 2023 and 2022, there were
0 and 23 of unvested restricted stock awards issued totaling $0 and $2,342, respectively, based on a fair value of the Company’s
common stock on the respective date of grant. There were no restricted stock awards granted during the years ended December 31, 2023
and 2022. There were 0 and 60 of restricted stock awards forfeited during the years ended December 31, 2023 and 2022, respectively. The
Company recognized $2,342 and $37,520 of stock based compensation for vested restricted shares during the years ended December 31, 2023
and 2022, respectively.
As of January 1, 2023, there were a total of
117,210 options outstanding with a weighted average exercise price of $53.81. During the year ended December 31, 2023, there were a total
of 18,324 options forfeited with a weighted average exercise price of $44.56. As of December 31, 2023, there were a total of 98,886 options
outstanding with a weighted average exercise price of $55.52 and weighted average remaining contractual life of 7.1 years, of which 82,880
options are exercisable with a weighted average exercise price of $61.25 and weighted average remaining contractual life of 7.0 years.
As of December 31, 2023, $121,000 of total time-based unrecognized compensation costs related to unvested stock options within the 2017
Plan. These costs are expected to be recognized over a weighted average period of 0.9 years.
2022
Plan
The
following is a summary of stock option activity under the activity under the 2022 Plan for the year ended December 31, 2023:
| 2022 Plan: |
|
Number of
Shares
(in thousands) |
|
|
Weighted
Average
Exercise
Price |
|
|
Weighted-
Average
Remaining
Contractual
Term
(Years) |
|
|
Aggregate
Intrinsic
Value
(in thousands) |
|
| Options outstanding at January 1, 2023 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
| Forfeited |
|
|
(24,050 |
) |
|
|
8.29 |
|
|
|
— |
|
|
|
— |
|
| Exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
| Granted |
|
|
100,850 |
|
|
|
7.80 |
|
|
|
— |
|
|
|
— |
|
| Options outstanding at December 31, 2023 |
|
|
76,800 |
|
|
$ |
7.67 |
|
|
|
9.3 |
|
|
|
— |
|
| Options exercisable at December 31, 2023 |
|
|
10,000 |
|
|
$ |
7.30 |
|
|
|
9.5 |
|
|
|
— |
|
Under
the 2022 Plan, the Company may grant equity-based awards to individuals who are employees, officers, directors, or consultants of the
Company. Options issued under the 2022 Plan will generally expire ten years from the date of grant and vest over a one-year to three-year
period.
In
accordance with Mr. Chipman’s Separation Agreement with the Company, he received accelerated vesting of 23,812 of his
outstanding stock options (“Accelerated Options”) as of his separation date of June 30, 2023. Additionally, these Accelerated
Options could be exercised until severance was fully paid, which was on October 15, 2023. Accelerated Options were not exercised as of
that date and were cancelled. The accelerated vesting and increase in the time to exercise option awards after termination was treated
as a stock option modification under ASC 718, Compensation - Stock Compensation. The total incremental expense resulting
from the modification was de minimis for the year ended December 31, 2023.
The
weighted-average grant-date fair value of stock options granted during the years ended December 31, 2023 and 2022 was $6.34 and $19.80,
respectively.
As of December 31, 2023, there was $231,000 of
total time-based unrecognized compensation costs related to unvested stock options under the 2022 Plan. These costs are expected to be
recognized over a weighted average period of 2 years.
Note
8. Income Taxes
Deferred
income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting
purposes and the amounts used for income tax purposes. The Company’s deferred tax assets relate primarily to its net operating
loss carryforwards and other balance sheet basis differences. In accordance with ASC 740, the Company recorded a valuation allowance
to fully offset the deferred tax asset, because it is not more likely than not that the Company will realize future benefits associated
with these deferred tax assets at December 31, 2023 and 2022. During the years ended December 31, 2023 and 2022, there was no income
tax expense.
Significant
components of the Company’s deferred tax assets at December 31, 2023 and 2022:
| |
|
December 31,
2023 |
|
|
December 31,
2022 |
|
| Deferred tax assets: |
|
|
|
|
|
|
| Net-operating loss carryforwards |
|
$ |
8,854,000 |
|
|
$ |
8,206,000 |
|
| Capitalized R&D costs |
|
|
3,562,000 |
|
|
|
2,868,000 |
|
| Stock-based compensation |
|
|
829,000 |
|
|
|
922,000 |
|
| Accrued expenses |
|
|
1,989,000 |
|
|
|
743,000 |
|
| R&D credit |
|
|
654,000 |
|
|
|
546,000 |
|
| Other |
|
|
5,000 |
|
|
|
6,000 |
|
| Total deferred tax assets |
|
|
15,893,000 |
|
|
|
13,291,000 |
|
| Valuation allowance |
|
|
(15,893,000 |
) |
|
|
(13,291,000 |
) |
| Net deferred tax asset |
|
$ |
— |
|
|
$ |
— |
|
The Tax Cuts and Jobs Act modified the section 174 rules and beginning
in 2022, taxpayers may no longer currently deduct R&D expenditures but instead must amortize specified R&D expenditures ratably
over five years (or 15 years for foreign expenditures). Gross capitalized R&D Costs for the years ended December 31, 2023 and 2022
amounted to approximately $5,118,000 and $10,559,000, respectively.
The change in the valuation allowance for the years ended December
31, 2023 and 2022 was an increase of approximately $2,602,000 and $6,623,000, respectively.
The
Company’s reconciliation of the federal statutory tax rate and the effective tax rates for the years ended December 31, 2023 and
2022 is as follows:
| | |
December 31,
2023 | | |
December 31,
2022 | |
| Federal statutory rate | |
| 21.0 | % | |
| 21.0 | % |
| Increase (decrease) in tax expense at federal statutory rate | |
| | | |
| | |
| State income taxes | |
| 5.0 | % | |
| 7.9 | % |
| Change in state income tax rate | |
| (9.2 | )% | |
| 0.0 | % |
| Change in valuation allowance | |
| (17.1 | )% | |
| (31.0 | )% |
| Other | |
| 0.3 | % | |
| 2.1 | % |
| Effective tax rate | |
| 0.0 | % | |
| 0.0 | % |
The Company had approximately $35,164,000 of gross net operating loss
(“NOL”) carryforwards and apportioned state NOL’s of approximately $37,095,000 as of December 31, 2023. The Company
has an R&D tax credit carryforward of approximately $654,000 as of December 31, 2023.
The
Company’s ability to use net operating loss, other carry forwards and tax credits is subject to limitation in subsequent periods
under certain provisions of Section 382 and Section 383 of the Internal Revenue Code of 1986, as amended, upon a more than 50% change
in ownership of the Company’s stock by a 5% or greater shareholder. The Company examined the application of Section 382 with respect
to ownership changes that took place during 2021, as well as the limitation on the application of net operating loss carry forwards.
The Company has determined that a more than 50% ownership change occurred on September 16, 2021. The Company has determined that the
recent change in ownership limits the Company’s usage of net operating loss, other carry forwards and tax credits of approximately
$19,417,000 as of the change in ownership date to an annual amount of approximately $4.1 million which will be released by December 31,
2028. The Company’s net carryforwards and tax credits may be further limited in the future if additional ownership changes occur.
From the total of the Company’s federal NOL of $35,164,000, $326,000
expires in 2037, and the remaining NOL has an indefinite carryover period but its usage is limited to 80% of taxable income in any subsequent
year. The Company’s state NOL’s of $37,095,000 expire from 2037 through 2043. Additionally, the Company has $654,000
of R&D credits which have a 20-year carryforward period, which will expire from 2038 to 2043.
Note
9. Research and Development and License Agreements
MedPharm
Limited
Research
and Option Agreement
On
April 11, 2017, the Company entered into a research and option agreement, as amended on May 30, 2018 (the “MedPharm Research and
Option Agreement”), with MedPharm Limited, a company organized and existing under the laws of the United Kingdom (“MedPharm”),
pursuant to which MedPharm granted the Company an option to obtain an exclusive, world-wide, royalty bearing license to use certain technology
developed by MedPharm. Pursuant to the MedPharm Research and Option Agreement, MedPharm will conduct certain research and development
of proprietary formulations incorporating certain MedPharm technologies and certain of the Company’s proprietary molecules.
Under
the MedPharm Research and Option Agreement, MedPharm granted the Company an option (the “MedPharm Option”) to obtain an exclusive
(even to MedPharm), worldwide, sub-licensable (through multiple tiers), royalty bearing, irrevocable license to research, develop, market,
commercialize, and sell any product utilizing MedPharm’s spray formulation technology which is the result of the activities performed
under the MedPharm Research and Option Agreement, subject to the Company’s entry into a definitive license agreement with MedPharm.
In order to exercise the MedPharm Option, the Company must provide MedPharm with written notice of such exercise before the end of the
Option Period (as defined in the MedPharm Research and Option Agreement). The Option Period is subject to extension upon mutual agreement
with MedPharm.
Pursuant
to the MedPharm Research and Option Agreement, the Company has a right of first refusal with respect to any license or commercial arrangement
involving any Licensed Intellectual Property (as defined in the MedPharm Research and Option Agreement) in combination with any Virpax
Molecule (as defined in the MedPharm Research and Option Agreement). In the event that MedPharm reaches an agreement with respect to
a license or other commercial arrangement that involves technology or molecules covered by the right of first refusal, the Company has
ten business days from the date of notice to notify MedPharm of its intention to exercise the right of first refusal and the Company’s
intention to match the financial terms of the other license or commercial arrangement.
License
Agreement
On
June 6, 2017, as a result of the Company’s exercise of the MedPharm Option under the MedPharm Research and Option Agreement, the
Company entered into a license agreement, as amended on September 2, 2017 and October 31, 2017 (the “MedPharm License Agreement”),
with MedPharm for the exclusive global rights to discover, develop, make, sell, market, and otherwise commercialize any pharmaceutical
composition or preparation (in any and all dosage forms) in final form containing one or more compounds, including Diclofenac Epolamine
(“Epoladerm”), that was developed, manufactured or commercialized utilizing MedPharm’s spray formulation technology
(“MedPharm Product”), to be used for any and all uses in humans (including all diagnostic, therapeutic and preventative uses).
Under the MedPharm License Agreement, the Company is required to make future milestone and royalty payments to MedPharm. We are obligated
to make aggregate milestone payments to MedPharm of up to GBP 1.150 million upon the achievement of specified development milestones
(payable in Great British Pounds). Additional milestone payments are due upon the achievement of certain development and commercial milestones
achieved outside the United States, payable on a country-by-country basis. Royalty payments must be paid to MedPharm in an amount equal
to a single-digit percentage of net sales of all MedPharm Product sold by us during the royalty term in the territory. Royalties shall
be payable, on a country-by-country basis, during the period of time commencing on the first commercial sale and ending upon the expiration
of the last-to-expire patent claim on the licensed product, which is set to expire on December 4, 2028. Each party has the right to terminate
the agreement in its entirety upon written notice to the other party if such other party is in material breach of the agreement and has
not cured such breach within ninety (90) days after notice from the terminating party indicating the nature of such breach.
LipoCureRx,
Ltd.
On
March 19, 2018, the Company entered into a license and sublicense agreement (the “Lipocure Agreement”) with LipocureRx, Ltd.,
a company organized and existing under the laws of Israel (“Lipocure”), for the sole and exclusive global license and sub-license
rights to discover, develop, make, sell, market, and otherwise commercialize bupivacaine liposome, in injectable gel or suspension (“Licensed
Compound”) or any pharmaceutical composition or preparation (in any and all dosage forms) in final form, including any combination
product, containing a Licensed Compound (“Licensed Product”), including Probudur. Under the Lipocure Agreement, the Company
was required to pay an upfront fee upon signing of $150,000 and is required to make future milestone and royalty payments to Lipocure.
The Company is obligated to make aggregate milestone payments of up to $19.8 million upon the achievement of specified development and
commercial milestones. Lipocure met the development milestone of $300,000 in the third quarter of 2023 for successfully completing a
formulation for the Licensed Product. The Company paid $150,000 in the third quarter of 2023 and paid the balance in the fourth quarter
of 2023. Royalty payments must be paid in an amount equal to a single digit to low double-digit percentage of annual net sales of royalty
qualifying products, subject to certain adjustments. Royalties shall be payable during the period of time, on a country-by-country basis,
commencing on the first commercial sale and ending upon the expiration of the last-to-expire patent claim on the licensed product, which
is set to expire on July 24, 2030. Each party has the right to terminate the agreement in its entirety upon written notice to the other
party if such other party is in material breach of the agreement and has not cured such breach within ninety (90) days after notice from
the terminating party indicating the nature of such breach.
The
Company incurred $300,000 and $0 in research and development expenses, respectively, for the years ended December 31, 2023 and 2022.
associated with this Lipocure agreement.
Nanomerics
Ltd.
Nanomerics
Collaboration Agreement
On
April 11, 2019, the Company entered into an exclusive collaboration and license agreement, as amended (the “Nanomerics Collaboration
Agreement”), with Nanomerics Ltd., a company organized and existing under the laws of United Kingdom (“Nanomerics”),
for the exclusive world-wide license to develop and commercialize products, including Envelta™, which contain hydrophilic neuropeptide
Leucin5-Enkephalin and an amphiphile compound which is quaternary ammonium palmitoyl glycol chitosan, to engage in a collaborative program
utilizing Nanomerics’ knowledge, skills and expertise in the clinical development of products and to attract external funding for
such development. The Nanomerics Collaboration Agreement was also amended to include a program for the pre-clinical development of a
product for post-traumatic stress disorder (“PTSD”).
Under
the Nanomerics Collaboration Agreement, the Company is required to make royalty payments equal to a single digit percentage of annual
net sales of royalty qualifying products. The Company is also required to make aggregate milestone payments of up to $103 million upon
the achievement of specified development and commercial milestones, and sublicense fees for any sublicense relationships it enters into
subsequent to the Nanomerics Collaboration Agreement. The Company’s obligation to pay royalties, on a country-by-country basis,
shall commence on the date of first commercial sale of its licensed products and shall expire with respect to each separate licensed
product, on the latest to occur of (a) the tenth (10th) anniversary of the first commercial sale of the first licensed product; (b) the
expiration date of the last to expire of any valid claim (patent is set to expire on November 3, 2034); and, (c) the date upon which
a generic product has been on the market for a period of no fewer than ninety (90) days. The Company has the right to terminate the agreement
upon 180 days’ prior written notice to Nanomerics. Upon termination, the Company shall assign to Nanomerics all its right title
and interest in all results other than results specific to (a) the Device (as defined in the Nanomerics Collaboration Agreement), including
its manufacture or use; and (b) the Technology, but excluding any clinical Results relating to the Compound or Licensed Products (all
terms as defined in the Nanomerics Collaboration Agreement).
Nanomerics
License Agreement (AnQlar)
On
March 9, 2022, the Company entered into an Amended and Restated Collaboration and License Agreement with Nanomerics (the “Amended
Nanomerics License Agreement”) which amended and restated the August 7, 2020, Nanomerics License Agreement and expanded the Company’s
North American rights for AnQlar to include exclusive global rights to develop and commercialize AnQlar as a viral barrier to prevent
or reduce the risk or the intensity of viral infections. The Amended Nanomerics License Agreement provides for payments up to $5.5 million
upon the achievement of specified development milestones and profit share payments equal to between 30% to 40% of certain profits (as
set forth in the Amended Nanomerics License Agreement), payable to Nanomerics upon the achievement of specified commercial milestones.
The profit share payments are triggered upon determination by the FDA that AnQlar may be marketed as an Over-the-Counter product in the
United States. In the event the profit share payments are not triggered as defined above, the Company’s would be obligated to pay
royalties within a range of 5% to 15% of annual net sales of royalty qualifying products and commercial milestones on a worldwide basis
amounting to aggregate milestone payments of up to $112.5 million upon the achievement of these commercial milestones. The Amended Nanomerics
License Agreement also provides for additional aggregate milestone payments totaling $999,999 upon first receipt of regulatory approval
for a licensed product in the European Union, Asia/Pacific region and South America/Middle East region. The Company’s obligation
to pay royalties, on a country-by-country basis, shall commence on the date of first commercial sale of its licensed products and shall
expire with respect to each separate licensed product, on the latest to occur of (a) the tenth (10th) anniversary of the first commercial
sale of the first licensed product; (b) the expiration date of the last to expire of any valid claim; and, (c) the date upon which a
generic product has been on the market for a period of no fewer than ninety (90) days. The Company has the right to terminate the Nanomerics
License Agreement upon sixty (60) days’ prior written notice to Nanomerics. Upon termination, the Company shall assign to Nanomerics
all its rights, title and interest in all of its results. Nanomerics has the right to terminate the agreement upon sixty (60) days’
prior written notice. In consideration for entering into this Amended Nanomerics License Agreement, the Company paid Nanomerics a nonrefundable
fee of $1,500,000 in March 2022, which is included in research and development expenses during the year ended December 31, 2022.
Nanomerics
License Agreement (NobrXiol, formerly VRP324)
On
September 17, 2021, the Company entered into a collaboration and license agreement with Nanomerics (the “Nanomerics License Agreement
- NobrXiol”) for the exclusive worldwide license to develop and commercialize an investigational formulation delivered via the
nasal route to enhance pharmaceutical-grade cannabidiol (“CBD”) transport to the brain to potentially treat seizures associated
with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome and Dravet syndrome in patients one year of age and older. Lennox-Gastaut
syndrome and Dravet syndrome are rare central nervous system diseases considered serious epileptic encephalopathies that cause different
types of epileptic seizures as well as cognitive and behavioral changes and are generally resistant to treatment. Under the Nanomerics
License Agreement – NobrXiol, the Company is required to make royalty payments within a range of 5% to 15% of annual net sales
of royalty qualifying products. The Company’s obligation to pay royalties, on a country-by-country basis, shall commence on the
date of first commercial sale of its licensed products and shall expire with respect to each separate licensed product, on the latest
to occur of (a) the fifteenth (15th) anniversary of the first commercial sale of the first licensed product; (b) the expiration date
of the last to expire of any valid claim; and, (c) the date upon which a generic product has been on the market for a period of no fewer
than ninety (90) days. The Company paid an upfront milestone payment upon signing of $200,000 and is required to make future milestone
and royalty payments of up to $41 million upon the achievement of specified development and commercial milestones, and sublicense fees
for any sublicense relationships the Company enters into subsequent to the Nanomerics License Agreement (any patent that is issued from
the currently filed provisional patent application would expire on August 24, 2041). The Company has the right to terminate the Nanomerics
License Agreement upon one hundred and eighty (180) days’ prior written notice to Nanomerics. Upon termination, the Company shall
assign to Nanomerics all its rights, title and interest in all of its results. Nanomerics has the right to terminate the agreement upon
thirty (30) days’ prior written notice if the Company concludes in writing to Nanomerics that the study aim has not been achieved
or the Company notifies Nanomerics that the Company has decided against proceeding with a Phase 3 Clinical trial.
On
April 21, 2022, we notified Nanomerics that the study aim of demonstrating the ability of Nanomerics platform technology delivering CBD
to the brain via nasal administration in an animal model was met. Pursuant to the Nanomerics License Agreement - VRP324, we paid a milestone
payment of $500,000 upon meeting this study aim in April 2022.
Research
Agreements
Yissum
On
June 30, 2021, the Company entered into an Agreement for Rendering of Research Services with Yissum Research Development Company of the
Hebrew University of Jerusalem Ltd (“Yissum”) (the “June 2021 Yissum Research Agreement”). Under the June 2021
Yissum Research Agreement, the Company provided funding for research and development studies performed by researchers at Hebrew University
related to the optimization of the Liposomal Bupivacaine formulation (Probudur) and to increase stability for manufacturing purposes.
In consideration for the research services, the Company agreed to pay research service fees of $337,500 in six equal quarterly installments.
On
January 31, 2023, the Company entered into an Agreement for Rendering of Research Services with Yissum (the “January 2023 Yissum
Research Agreement”) on substantially similar terms and conditions as detailed above under the June 2021 Yissum Research Agreement.
Under the January 2023 Yissum Research Agreement, the Company agreed to provide funding for research and development studies to be performed
by researchers at Hebrew University related to the optimization of the Liposomal Bupivacaine formulation (Probudur) and to increase stability
for manufacturing purposes. In consideration for the research services, the Company agreed to pay research service fees of $326,000 in
four equal quarterly installments ($81,500 per calendar quarter).
The Company incurred $326,000 and $225,000 in
research and development expenses respectively for the years ended December 31, 2023 and 2022 associated with these Yissum agreements.
Lipocure
On
June 29, 2021, the Company entered into an Agreement for Rendering of Research Services (the “June 2021 Lipocure Research Agreement”)
with Lipocure RX, Ltd. (“Lipocure”). Under the June 2021 Lipocure Research Agreement, the Company agreed to provide funding
for research and development related to the optimization of the Liposomal Bupivacaine formulation and eventual manufacture of pre-clinical
batches including batches for stability testing, animal studies, toxicology, and patent related work. In consideration for the research
services, the Company agreed to pay research service fees of $200,000 upon execution, $400,000 in July 2021, $270,000 in both September
2021 and January 2022, and three additional payments of $270,000 during 2022. The Company also agreed to pay $250,000 to Lipocure upon
successful completion of a Chemistry, Manufacturing and Controls “CMC” filing with the U.S. Food and Drug Administration
(the (“FDA”).
On
February 1, 2023, the Company entered into an Agreement for Rendering of Research Services with Lipocure on similar terms and conditions
and for similar services - optimization of the Liposomal Bupivacaine formulation, manufacture of pre-clinical batches including batches
for stability testing, animal studies, toxicology, and patent related work. In consideration for the research services, the Company agreed
to pay research service fees of $1,286,000 in four equal quarterly installments ($321,500 per calendar quarter), as well as reasonable
pass-through expenses.
The Company incurred $1,453,000 and $1,220,000
in research and development expenses, respectively, for the years ended December 31, 2023 and 2022 associated with these Lipocure agreements.
NCATS-NIH
Cooperative Research and Development Agreement
On August 25, 2020, the Company entered into
a Cooperative Research and Development Agreement (“CRADA”) with the National Center for Advancing Translational Science (“NCATS”).
This collaboration is for the continued development of the Company’s product candidate, Envelta, an intranasal peptide, to control
severe pain, including post cancer pain. The term of the CRADA is for a period of four years from May 6, 2020 (the effective date of
the agreement) and can be terminated by both parties at any time by mutual written consent. In addition, either party may unilaterally
terminate the CRADA at any time by providing written notice of at least sixty (60) days before the desired termination date. The agreement
provides for studies that are focused on the pre-clinical characterization of Envelta as a novel analgesic to control severe pain, including
post cancer pain, and for studies to further develop Envelta through IND enabling studies. There are certain development “Go/No
Go” provisions within the agreement whereby, if certain events occur, or do not occur, NCATS may terminate the CRADA. These “No
GO” provisions include: i) lack of efficacy in all animal pain models, ii) no reliable and sensitive bioanalytical method can be
developed, iii) manufacturing failure due to inherent process scalability issues, iv) unacceptable toxicity or safety profile to enable
clinical dosing, and v) inability to manufacture the Envelta dosage form. As of March 25, 2024, we have not received any Go/No Go notifications
from NCATS.
With
respect to NCATS rights to any invention made solely by an NCATS employee(s) or made jointly by an NCATS employee(s) and our employee(s),
the CRADA grants to the Company an exclusive option to elect an exclusive or nonexclusive commercialization license. For inventions owned
solely by NCATS or jointly by NCATS and the Company, and licensed pursuant to the Company’s option, the Company must grant to NCATS
a nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention or have the invention practiced throughout the
world by or on behalf of the United States government. For inventions made solely by an employee of the Company, we grant to the United
States government a nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention or have the invention practiced
throughout the world by or on behalf of the United States government for research or other government purposes.
U.S
Army Institute of Surgical Research
On
April 28, 2022, the Company entered into a CRADA with the U.S. Army Institute of Surgical Research (USAISR) to evaluate Probudur as a
potential novel analgesic for battlefield injury-induced pain solution. The research project will evaluate the analgesic effectiveness
and physiologic effects of Probudur. The initial term of this agreement was to expire on September 30, 2023 unless it was revised by
mutual written agreement. The CRADA was modified and signed on October 10, 2023, and extended the terms of the agreement until September
2024. No funding is being provided by either party to the other party under the agreement. Each party is responsible for funding its
own work performed and other activities undertaken for the research project under this agreement. The parties may elect to terminate
this agreement, or portions thereof, at any time by mutual consent. Either party may unilaterally terminate this entire agreement at
any time by giving the other party written notice, not less than thirty (30) days prior to the desired termination date.
Note
10. Subsequent Events
The Company has evaluated subsequent events from
the balance sheet date through March 25, 2024. In addition to those disclosed in Note 5 and Note 6, the following are subsequent events:
On
January 1, 2024, we entered into an Agreement for Rendering of Research Services with Yissum (the “January 2024 Yissum Research
Agreement”) for additional work on formulation, method development, animal studies and patent related work. In consideration for
the research services, we will pay research service fees of $343,467 in four equal quarterly installments. We may terminate the agreement
at any time and will only be responsible to pay Yissum for work performed through the date of termination.
F-21
EXHIBIT 23.1
To Whom It May Concern:
We consent to the incorporation by reference in the Registration Statement
of Virpax Pharmaceuticals, Inc. on Form 10-K/A of our report dated October 4, 2024, on our audits of the financial statements as of December
31, 2023 and 2022 and for each of the years then ended, which report is included in this Annual Report on Form 10-K/A to be filed on or
about October 10, 2024. Our report includes an explanatory paragraph about the existence of substantial doubt concerning the Company’s
ability to continue as a going concern.
We also consent to the references to us under the headings “Experts”
in such Registration Statement.
Very truly yours,
/s/ Bush & Associates CPA LLC
Bush & Associates CPA LLC (PCAOB 6797)
Henderson, Nevada
October 10, 2024
179 N. Gibson Rd., Henderson, NV 89014 l 702.703.5979
l www.bushandassociatescpas.com
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Jatinder Dhaliwal, certify that:
| |
1. |
I
have reviewed this annual report on Form 10-K for the period ended December 31, 2023 of Virpax Pharmaceuticals, Inc.; |
| |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| |
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in the Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| |
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| |
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; ; |
| |
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| |
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| |
5. |
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s Board of Directors (or persons performing the equivalent functions): |
| |
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| |
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| |
Date: October 10, 2024 |
| |
|
| |
/s/ Jatinder Dhaliwal |
| |
Jatinder Dhaliwal |
| |
Chief Executive Officer |
| |
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Jatinder Dhaliwal, certify that:
| |
1. |
I
have reviewed this annual report on Form 10-K for the period ended December 31, 2023 of Virpax Pharmaceuticals, Inc.; |
| |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| |
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in the Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| |
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| |
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; ; |
| |
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| |
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| |
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s Board of Directors (or persons performing the equivalent functions): |
| |
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| |
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| |
Date: October 10, 2024 |
| |
|
| |
/s/ Jatinder Dhaliwal |
| |
Jatinder Dhaliwal |
| |
Principal Financial Officer |
| |
(Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND
Principal Financial Officer PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
This Certification is being filed pursuant to 18 U.S.C. Section 1350, as
adopted by Section 906 of the Sarbanes-Oxley Act of 2002. This Certification is included solely for the purposes of complying with the
provisions of Section 906 of the Sarbanes-Oxley Act and is not intended to be used for any other purpose. In connection with the accompanying
Annual Report on Form 10-K of Virpax Pharmaceuticals, Inc. (the “Company”) for the year ended December 31, 2023 (the “Annual
Report”), Jatinder Dhaliwal, as Chief Executive Officer, certifies in his capacity as such officer of the Company, that to such
officer’s knowledge:
| |
1) |
The Annual Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| |
2) |
The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| Dated: October 10, 2024 |
By: |
/s/ Jatinder Dhaliwal |
| |
Name: |
Jatinder Dhaliwal |
| |
Title: |
Chief Executive Officer |
| |
|
(Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND
Principal Financial Officer PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
This Certification is being filed pursuant to 18 U.S.C. Section 1350, as
adopted by Section 906 of the Sarbanes-Oxley Act of 2002. This Certification is included solely for the purposes of complying with the
provisions of Section 906 of the Sarbanes-Oxley Act and is not intended to be used for any other purpose. In connection with the accompanying
Annual Report on Form 10-K of Virpax Pharmaceuticals, Inc. (the “Company”) for the year ended December 31, 2023 (the “Annual
Report”), Jatinder Dhaliwal, as Principal Financial Officer, certifies in his capacity as such officer of the Company, that to such
officer’s knowledge:
| |
1) |
The Annual Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| |
2) |
The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| Dated: October 10, 2024 |
By: |
/s/ Jatinder Dhaliwal |
| |
Name: |
Jatinder Dhaliwal |
| |
Title: |
Principal Financial Officer |
| |
|
(Principal Financial Officer) |
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