Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 15, 2023

Virpax Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-40064		82-1510982
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

1055 Westlakes Drive, Suite 300

Berwyn, PA 19312

(Address of principal executive offices, including zip code)

(610) 727-4597

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class:		Trading Symbol		Name of Each Exchange on which Registered
Common Stock, par value $0.00001 per share		VRPX		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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. ☐

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On November 15, 2023, Virpax Pharmaceuticals, Inc. (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.

On November 15, 2023, the Company’s Board appointed Gerald Bruce as CEO and Dr. Eric Floyd as Chair of the Board, effective as of November 20, 2023. Dr. Floyd also serves as Chair of the Compensation Committee.

Gerald Bruce, age 67, has served as the Company’s Executive Vice President of Commercial Operations Officer since August 2017, as a member of the Company’s Board since July 2021 and as the President and CEO of the Company’s wholly owned subsidiary, Novvae Pharmaceuticals, Inc. since July 26, 2023. Mr. Bruce has spent over 30 years, in the Pharmaceutical and Medical Nutrition industry, including 20 years in senior leadership roles. 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. (“Bristol-Myers”) 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’ 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.

Dr. Eric Floyd, age 61, has served as a member of the Company’s Board since January 2017. Dr. Floyd currently serves as Senior Vice President of Regulatory Affairs & Quality Assurance at Silence Therapeutics. He has more than 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. from 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 until April 2007. 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.

The Company has not yet determined Mr. Bruce’s compensation for serving as Chief Executive Officer nor if any additional compensation will be paid to Dr. Floyd for serving as Chair of the Board.

Item 7.01. Regulation FD Disclosure.

On November 17, 2023, the Company issued a press release disclosing the foregoing. A copy of the press release is furnished with this Current Report on Form 8-K as Exhibit 99.1 and incorporated by reference into this Item 7.01.

The information in this Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with the SEC made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Exhibit Description

99.1		Press Release dated November 17, 2023 issued by Virpax Pharmaceuticals, Inc.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

Signature

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	VIRPAX PHARMACEUTICALS, INC.

Dated: November 17, 2023	By:	/s/ Vinay Shah
		Vinay Shah
		Chief Financial Officer

Exhibit 99.1

Virpax Pharmaceuticals Announces Leadership Transition

BERWYN, PA – November 17, 2023 — Virpax^® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral barrier indications, today announced that due to ongoing litigation it has accepted the resignation of Anthony P. Mack as CEO and Chairman effective immediately. The Board has appointed Gerald Bruce as CEO and Dr. Eric Floyd as Chairman.

Mr. Bruce has served as the Company’s Executive Vice President of Commercial Operations since August 2017, as a member of the Company’s Board since July 2021 and as the President and CEO of the Company’s wholly owned subsidiary, Novvae Pharmaceuticals, Inc. since July 26, 2023. Prior to Virpax, Mr. Bruce served as Vice President of sales for Danone Specialized Nutrition North America, Danone’s medical nutrition division. Prior to this position, he has held roles of increasing responsibility at Nitromed, Inc. and Bristol-Meyers Squibb. Mr. Bruce began his career at Johnson and Johnson and moved up the ranks to become a Group Marketing Director in Analgesics. He has a BA from Lincoln University and a Master’s degree in Leadership from Georgetown University’s McDonough School of Business.

Dr. Floyd is Senior Vice President of Regulatory Affairs and Quality Assurance at Silence Therapeutics. He has over 25 years of pharmaceutical and biotechnology experience in Regulatory Affairs roles of increasing responsibility at Merck, Aventis, Novartis, Lundbeck, Axovant Sciences, and Neurogene, Inc. Most recently, he served as founder and Chief Regulatory Officer at Neurogene, Inc. Neurogene is focused on developing life-changing genetic medicines for patients and their families affected by rare, devastating neurological diseases. Dr. Floyd previously served as the Global Head of Regulatory Affairs at Axovant Sciences and the U.S. Head of Regulatory Affairs at Lundbeck, where he was responsible for strategic regulatory and clinical development activities related to the company’s approvals of Sabril, Onfi, Northera (orphan approvals) as well as Anti-Depression and Schizophrenia drug approvals. Dr. Floyd serves as an adjunct faculty member in the Department of Neuroscience at Harvard Medical School and Wake Forest University School of Medicine. Aside from Virpax Pharmaceuticals, he also serves on the board of Advent Therapeutics Inc. and is a member of the Board of Trustees of Meharry Medical College. Dr. Floyd completed his undergraduate degree in Biology from the University of Illinois, a Master’s degree in Neuroscience from Tennessee State University, a Doctorate in Neurophysiology from Meharry Medical College, an Executive MBA in Pharmaceutical Marketing from Saint Josephs’ University and completed the Global Executive MBA in International Business from the INSEAD Business School in Fontainebleau, France.

“It has been an honor to lead a team of such dedicated and talented colleagues. I am proud of what we have accomplished together and confident that Virpax under Gerald and Eric’s leadership will remain on track to begin first-in-human trials in the coming year,” commented Mr. Mack.

About Virpax Pharmaceuticals

Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop two other product candidates. PES200 is a product candidate being developed to manage post-traumatic stress disorder (PTSD) and NobrXiol™ is a product candidate being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax has competitive cooperative research and development agreements (CRADAs) for all three of its prescription drug candidates, two with the National Institutes of Health (NIH) and one with the Department of Defense (DOD). Virpax is also seeking approval of two nonprescription product candidates: AnQlar™, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit virpaxpharma.com and follow us on Twitter, LinkedIn and YouTube.

Confidential data (L2). Printed copies are uncontrolled and must be destroyed after use.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s planned clinical trials, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms and include statements regarding the Company remaining on track to begin first-in-human trials in the coming year. These statements relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors, including the contribution of Mr. Bruce and Dr, Floyd to the Company and the impact of any damages or remedies awarded in the additional proceedings of the lawsuit filed in the Delaware Chancery Court against the Company; the Company’s ability to successfully begin trials when expected and complete research and further development and commercialization of Company drug candidates in current or future indications; the uncertainties inherent in clinical testing; the Company’s ability to manage and successfully complete clinical trials and the research and development efforts for multiple product candidates at varying stages of development; the timing, cost and uncertainty of obtaining regulatory approvals for the Company’s product candidates; the Company’s ability to protect its intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s product candidates; the Company’s ability to continue to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete clinical trials that the Company plans to initiate; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q that the Company files with the U.S. Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Relations Contact:

Betsy Brod

Affinity Growth Advisors

Betsy.brod@affinitygrowth.com

(917) 923-8541

Media Contact:

Robert Cavosi

RooneyPartners

rcavosi@rooneypartners.com

(646) 638-9891

Confidential data (L2). Printed copies are uncontrolled and must be destroyed after use.

Cover	Nov. 15, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 15, 2023
Entity File Number	001-40064
Entity Registrant Name	Virpax Pharmaceuticals, Inc.
Entity Central Index Key	0001708331
Entity Tax Identification Number	82-1510982
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1055 Westlakes Drive
Entity Address, Address Line Two	Suite 300
Entity Address, City or Town	Berwyn
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19312
City Area Code	610
Local Phone Number	727-4597
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.00001 per share
Trading Symbol	VRPX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false