Virpax Pharmaceuticals Enters into CRADA with the National Advisory Neurological Disorders and Stroke Council

By: Virpax Pharmaceuticals, Inc. via Business Wire

June 21, 2023 at 08:00 AM EDT

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 indications, today announced that it has entered into a cooperative research and development agreement (CRADA) with the National Institute of Neurological Disorders and Stroke (NINDS), part of the U.S. National Institutes of Health (NIH) Division of Translational Research which conducts and funds research on brain and nervous system disorders. Virpax will be partnering with the Epilepsy Therapy Screening Program (ETSP) whose mission is to identify novel agents to address unmet medical needs in epilepsy, including the identification of next generation products focused on addressing drug resistant epilepsy, disease prevention and modification. Under the CRADA, NINDS ETSP will evaluate Virpax’s NobrXiol^™ product candidate that is being developed for the management of rare pediatric epilepsy. NobrXiol utilizes a unique intranasal Molecular Envelope Technology (MET) delivery platform for pharmaceutical-grade cannabidiol (CBD).

ETSP provides opportunities for researchers in the US and abroad to submit compounds for screening in a battery of rodent epilepsy and seizure models. There is no cost to participants for these tests and the ETSP staff provides advice on next steps for promising compounds. The Program has made important contributions to the development of numerous FDA-approved drugs for epilepsy, including Epidiolex^®, the only FDA-approved cannabidiol (CBD) for the treatment of epilepsy.

“We are developing NobrXiol for the management of rare pediatric epilepsy and believe that with our MET delivery platform we may achieve higher bioavailability via the nasal route, faster onset and reduce side effects. This is an exciting collaboration for us and we look forward to working with this extremely knowledgeable group that is solely focused on the unmet medical needs of epilepsy,” stated Anthony P. Mack, Chairman and CEO of Virpax.

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 recently acquired global rights to NobrXiol. 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 opportunities to be provided with ETSP, the MET delivery platform achieving higher bioavailability via the nasal route, faster onset and reducing side effects and continuing to work with the extremely knowledgeable group that is solely focused on the unmet medical needs of epilepsy. These statements relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors, including the Company’s ability to derive the expected benefits from the collaboration with ETSP, the ability of the MET delivery platform to achieve higher bioavailability via the nasal route, faster onset and reduced side effects , 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 effects of the outbreak of COVID-19 on the Company’s business and results of operations; 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 most recent annual report on Form 10-K and subsequent 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.