BERWYN, Pa. / Jul 13, 2023 / 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 filed a new provisional patent application with the United States Patent and Trademark Office (‘USPTO’) entitled “Intranasal Delivery” related to its Envelta™ product candidate.

Envelta utilizes Molecular Envelope Technology (‘MET’) for the delivery of Enkephalin intranasally for severe cancer pain and non-cancer pain. The enkephalin/MET formulation is delivered using a delivery device which propels the formulation into nose such that the enkephalin is delivered to the brain. MET was developed by Nanomerics Ltd., a UK-based nanotechnology research and development company. Nanomerics has licensed its technology to Virpax, which is utilizing the nose-to-brain MET platform to enhance drug delivery for certain of its product candidates including Envelta. The development program for Envelta is being funded almost exclusively through a Cooperative Research and Development Agreement (‘CRADA’) with the National Center for Advancing Translational Sciences (‘NCATS’), part of the National Institute of Health.

“We are pleased with the continued development of our patent portfolio for Envelta,” stated Anthony P. Mack, Chairman and CEO of Virpax. “Recent toxicology studies for MET performed by NCATS on dogs demonstrated evidence of delivery of Envelta to the brain. We are utilizing this technology for a number of our programs as we believe the nose to brain intranasal drug delivery pathway, which avoids the blood-brain barrier, will lessen drug-to drug interaction and reduce drug dosing.”

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 continued development of our patent portfolio for Envelta and the nose to brain intranasal drug delivery pathway, which crosses the blood-brain barrier, lessening drug-to drug interaction and reduce drug dosing. 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 continue the development of the 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 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 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.