NRx Announces Publication of Topline Results of BriLife® Vaccine-Produced Antibodies Against Omicron Variant

RADNOR, Pa., January 27, 2022 /PRNewswire/ — NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company has received scientific evidence from the Israel Institute for Biological Research (IIBR) that the BriLife® vaccine can produce effective levels of neutralizing antibodies against the Omicron variant of SARS-CoV -2 viruses.¹ More importantly, numerous mutations (alterations) that cause the variant Omicron spike protein to differ from the spike protein of the original SARS-CoV-2 virus that causes COVID-19 have been identified in the spike protein of the BriLife vaccine. This natural evolution of the BriLife vaccine suggests that the vaccine could continue to evolve to address future variants of concern (COVs). Unlike current mRNA and attenuated virus vaccines, the BriLife vaccine is a live viral vector vaccine in which the spike protein from the SARS-CoV-2 virus has been added to a benign virus, called VSV. A similar viral vector was used to create the FDA-approved Ebola virus vaccine.

The results released yesterday were based on blood samples (sera) from patients vaccinated in the Phase 2 trial of the BriLife vaccine conducted in Israel. These sera indicated a mean neutralization titer (NT₅₀) of 53 against Omicron versus a titer of 152 against the original wild-type virus and 131 against the Delta variant. This 3-fold change against wild-type virus can be compared to the 20-fold decrement associated with mRNA vaccines, which helps explain the high infectivity of Omicron in currently vaccinated individuals.² The IIBR report documents that 10 of the 13 sera tested demonstrated clinically detectable levels of Omicron neutralizing antibodies.

The IIBR report concludes that “taken together, our data indicate that the antibodies elicited by BriLife® maintain neutralizing potential against all variants tested, and especially against delta and recently emerged omicron VOCs. We suggest that spontaneously acquired mutations that occurred during the development of BriLife® and correspond to natural mutations of SARS-CoV-2 variants, may increase the potential of BriLife® to maintain its efficacy against current SARS-CoV-2 variants. 2, and potentially against future VOCs. »

“We are extremely encouraged by the recent findings from the IIBR,” said the professor. Jonathan Javit, MD, MPH, CEO and President of NRx. “At a time when the majority of Western populations have been vaccinated with mRNA vaccines, there is a clear need for a booster vaccine capable of broadening immunity against current and future variants of concern. The BriLife vaccine has now demonstrated its potential to continue to evolve in a way that has the potential to protect against variants that are not yet known, and is planned to be tested as a booster in a phase 2 trial that will include Israel and other partner countries,

About NRx Pharmaceuticals

NRx Pharmaceuticals (NRx) draws on more than 300 years of collective, scientific and drug development experience to improve patient health. The Company is developing the BriLife™ Covid vaccine, developed by the Israel Institute for Biological Research, under exclusive license from the Israeli Ministry of Defense. NRx is further developing ZYESAMI® (aviptadil) for patients with COVID-19, and has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and is currently in phase trials. 3 funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, and the Medical Countermeasures Program, which is part of the US Department of defense. The FDA also granted Breakthrough Therapy Designation, Special Protocol Agreement, and Biomarker Support Letter to NRx for NRX-101, an investigational drug to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 testing, with readouts expected in 2022.

NRx is led by executives who have held leadership positions at Allergan, J&J, Lilly, Novartis, Pfizer and the US FDA. NRx is chaired by Prof. Jonathan Javit, MD, MPH, who has held executive positions at six biotech startups with public releases and served in advisory positions in four U.S. presidential administrations. NRx’s Board of Directors includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former US FDA Chief Counsel, Chaim Hurvitz, former Teva Director and Chairman of the Teva International Group, and RH General McMaster, Ph.D. (US Army, Ret.) the 26th National Security Advisor of the United States.

Caution Regarding Forward-Looking Statements

This announcement by NRx Pharmaceuticals, Inc. includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements about our financial situation. outlook, product development, business prospects and market and industry trends and conditions; and the Company’s strategies, plans, objectives and goals. These forward-looking statements are based on the Company’s management’s current beliefs, expectations, estimates, forecasts and projections, as well as assumptions made by the Company’s management and information currently available to it.

The Company undertakes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not rely on any forward-looking statements, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

CORPORATE CONTACT:	INVESTOR RELATIONS
Jack Hirschfield–	Eric Goldstein
Corporate Communications Manager, NRx	Managing Director – LifeSci Advisors
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