Virpax Pharmaceuticals Announces Proposed Settlement of Litigation with Sorrento Therapeutics, Inc. and Scilex Pharmaceuticals, Inc.

By: Virpax Pharmaceuticals, Inc. via Business Wire

February 27, 2024 at 07:30 AM EST

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 it has entered into a term sheet to settle the litigation with the Company and Sorrento Therapeutics, Inc. (Sorrento) and Scilex Pharmaceuticals, Inc. (Scilex and Sorento, collectively, the “Plaintiffs”). The term sheet sets forth the principal terms of a mutual release and settlement agreement to be entered into by the Company and the Plaintiffs. However, if the parties fail to do so by or before March 1, 2024, the term sheet will become binding.

As part of the settlement, the parties have agreed to a cash payment from Virpax to the Plaintiffs of $3.5 million by March 1, 2024, and $2.5 million by July 1, 2024, to settle all claims against Virpax. Additionally, Virpax will pay the plaintiffs royalties of 6% of annual net sales of products developed from drug candidates Epoladerm^™, Probudur^™ or Envelta^™ until the expiration of the last-to-expire valid patent claim and the expiration of any period of regulatory exclusivity. Each party releases all claims against the other party and neither party admits liability for any claim including those asserted in the lawsuit. Plaintiff’s release of Virpax is conditioned upon Virpax making its initial payment.

“I am pleased that we were able to bring this litigation to a satisfactory conclusion,” stated Gerald Bruce, CEO of Virpax Pharmaceuticals. “We are now able to fully focus all of our efforts on the development of our drug product candidates as well as the Investigational New Drug Applications (IND) for our two lead programs.”

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 one other prescription product candidate, NobrXiol™, which is 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 two of its prescription drug candidates, one 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.

Forward-Looking Statements

This press release contains certain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including those described below. 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 entry into a definitive agreement, the timing of the payments, each parties releases of claims, and the extent to which any of the noted drug candidates are ever sold and related royalty payments in respect thereof. These statements relate to future events and involve known and unknown risks, uncertainties, and other factors, including the inability of the Company to satisfy the terms of the final settlement agreement, including the payment of amounts owed thereunder the Company’s ability to obtain FDA approval for its prescription drug candidates and nonprescription drug candidates; the Company’s ability to maintain competitive cooperative research and development agreements (CRADAs) for its prescription drug candidates; the Company’s ability to successfully complete research and further development and commercialization of Company drug candidates in current or future indications; the Company’s ability to obtain additional grants to help fund upcoming clinical trials; the Company’s ability to move ahead with remaining confirmational studies for Probudur and Envelta™ as planned; 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 Company’s ability 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 the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240227926537/en/

Contacts

Investor Relations:

Betsy Brod

Affinity Growth Advisors

Betsy.brod@affinitygrowth.com

(917) 923-8541

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Virpax Pharmaceuticals Announces Proposed Settlement of Litigation with Sorrento Therapeutics, Inc. and Scilex Pharmaceuticals, Inc.

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