Virpax Pharmaceuticals Announces the Formation of Novvae™ Pharmaceuticals

Rhea-AI Summary

Virpax Pharmaceuticals forms subsidiary Novvae to focus on OTC pipeline, while Virpax focuses on Rx product pipeline. Novvae's first asset, AnQlar, demonstrated 24-hour anti-viral barrier activity against Influenza and Covid. Virpax in discussions for global rights of first refusal on two non-prescription assets.

--Novvae to Focus Exclusively on OTC Product Candidates—

--Clinical Trials for Virpax Rx Pipeline are Anticipated for 2024--

BERWYN, Pa.--(BUSINESS WIRE)-- 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 viral barrier indications, today announced that it has formed a new wholly-owned subsidiary, Novvae™ Pharmaceuticals, Inc. (Novvae), which has been established to focus exclusively on advancing Virpax’s OTC pipeline.

“The formation of Novvae allows Virpax to focus exclusively on the development of its Rx product pipeline as we advance our lead product candidate, Probudur^™ and prepare to enter Phase 2 human clinical trials in 2024. We are also looking to advance Envelta™ and expect to enter Phase 1 human clinical trials next year,” commented Anthony P. Mack, Chairman and CEO of Virpax Pharmaceuticals.

AnQlar^™ will be the first asset added to the Novvae pipeline. AnQlar is being developed as a prophylactic once-a-day antiviral nasal spray. AnQlar utilizes a pre-filled intranasal device that is formulated using a chitosan derivative in a nanoparticle dispersion. Chitosan is a natural anti-microbial. In several preclinical studies, AnQlar demonstrated 24-hour anti-viral barrier activity against both Influenza and Covid. AnQlar has completed IND-enabling studies and Novvae will assume responsibility for future development leading to its first in human trials.

Additionally, Virpax is in advanced discussions for global rights of first refusal on two differentiated non-prescription assets. Should the Company acquire these product candidates, they would be added to the Novvae pipeline.

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 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 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 formation of Novvae allowing the Company to focus exclusively on the development of its Rx product pipeline, advancing Probudur^™ and preparing to enter Phase 2 human clinical trials in 2024, advancing Envelta™ and entering Phase 1 human clinical trials next year, future development by Novvae leading to first in human trials for AnQlar, the Company acquiring the global rights of first refusal on two differentiated non-prescription assets and adding the product candidates to the Novvae pipeline. These statements relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors, including the ability to be in Phase 2 human clinical trials for Probudur^™ in 2024; the ability to be in Phase 1 human clinical trials for Envelta™ in 2024; the ability to be in first in human trials for AnQlar; the ability to acquire the global rights of first refusal on two differentiated non-prescription assets as planned; the ability to continue the development of the Company’s patent portfolio; the ability of the nose to brain intranasal drug delivery pathway to lessen drug-to drug interaction and reduce drug dosing; the Company’s ability to successfully 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 the Company’s annual report on Form 10-K for the year ended December 31, 2022, and the Company’s quarterly reports on Form 10-Q, the Company’s Current Reports on Form 8-K and subsequent filings 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.

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Source: Virpax Pharmaceuticals