Virpax Pharmaceuticals Enters Into CRADA With The U.S. Army Institute of Surgical Research

Rhea-AI Summary

Virpax Pharmaceuticals (NASDAQ: VRPX) has entered into a cooperative research and development agreement (CRADA) with the U.S. Army Institute of Surgical Research to evaluate Probudur, an injectable long-acting liposomal bupivacaine aimed at reducing postoperative opioid use. Probudur has demonstrated pain control for at least 96 hours in pre-clinical trials. This collaboration aligns with Virpax's strategy for non-dilutive funding and builds on prior partnership with the National Institutes of Health for another pain management product, Envelta.

Positive

• New CRADA with the U.S. Army Institute of Surgical Research could accelerate development of Probudur.
• Positive pre-clinical results showing Probudur offers pain control for at least 96 hours.
• Alignment of military research collaboration with company's non-dilutive funding strategy.

Negative

• None.

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 anti-viral indications, today announced that it has entered into a cooperative research and development agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR) to evaluate Virpax’s Probudur™, an injectable long-acting liposomal bupivacaine in a hydrogel formulation that is injected at the wound site. Probudur is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channel, preventing pain signals from reaching the brain. In pre-clinical trials, Probudur has shown long duration pain control for at least 96 hours. The USAISR is the U.S. Department of Defense’s (DOD) primary laboratory for developing solutions for trauma and critical care challenges in combat casualties.

“We are excited to announce this CRADA with the DOD as these military and government research collaborations are an integral part of our non-dilutive funding strategy,” stated Anthony P. Mack, chairman and CEO of Virpax.

In August of 2020, Virpax entered into a CRADA with the National Center for Advancing Translational Sciences, an institute of the National Institutes of Health (NIH), for the development of Envelta™, it’s intranasal spray product candidate for severe post-cancer pain and non-cancer pain. Under that agreement, multiple contracts to support the research, development, and manufacturing of Envelta have been awarded by the NIH to continue the product’s progress.

About Virpax Pharmaceuticals

Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular-Envelope Technology (MET) enkephalin formulation being developed for the management of post-cancer pain and non-cancer pain, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, Virpax’s product candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. For more information, please visit www.virpaxpharma.com.

Forward-Looking Statement

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. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors, including the potential impact of the COVID-19 pandemic and the potential impact of sustained social distancing efforts, on the Company’s operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the 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/20220505005208/en/

Christopher M. Chipman, CPA

Chief Financial Officer

cchipman@virpaxpharma.com

610-727-4597

Investor Relations:

Betsy Brod

Affinity Growth Advisors

betsy.brod@affinitygrowth.com

212-661-2231

Media:

Laura Radocaj

DGI

212-825-3210

Source: Virpax Pharmaceuticals, Inc.

FAQ

What is the recent agreement announced by Virpax Pharmaceuticals?

Virpax Pharmaceuticals announced a cooperative research and development agreement (CRADA) with the U.S. Army Institute of Surgical Research to evaluate Probudur.

What is Probudur and what are its benefits?

Probudur is an injectable long-acting liposomal bupivacaine designed to reduce the need for opioids after surgery, providing pain control for at least 96 hours.

How does the CRADA benefit Virpax Pharmaceuticals?

The CRADA allows Virpax to potentially expedite the development of Probudur while securing non-dilutive funding.

What is the significance of the collaboration with the U.S. Army?

The collaboration with the U.S. Army aids in addressing trauma and critical care challenges, enhancing the relevance of Virpax's product to military applications.