Heat Biologics (NightHawk Biosciences) Announces that its Elusys Therapeutics Subsidiary has Executed a Contract to Deliver ANTHIM® to the Canadian Government

On April 27, 2022 Heat Biologics, Inc. (NYSE American: HTBX) (to be renamed "NightHawk Biosciences"), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported to shareholders that its Elusys Therapeutics subsidiary has finalized a contract with the Canadian government to deliver ANTHIM (obiltoxaximab for injection), a treatment for inhalation anthrax, for use against a potential anthrax attack (Press release, NightHawk Biosciences, APR 27, 2022, View Source [SID1234613048]).

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ANTHIM will be delivered to Canada’s National Emergency Strategic Stockpile under a procurement contract totaling CAD $7.9 millioni. The goal of this program is to establish a Canadian supply of Anthim for use as a medical countermeasure against natural and man-made anthrax biothreats.

Jeff Wolf, CEO of Nighthawk and its Elusys subsidiary, commented, "We are excited to announce this first international contract to supply ANTHIM to Canada, which is particularly timely given the growing global geopolitical uncertainty and emerging threats. This agreement follows our recent acquisition of Elusys, which complements our broader biodefense initiatives. We are focused on expanding sales of ANTHIM, abroad and this first international contract is an important validation of our strategy."

According to the United States Centers for Disease Control and Prevention (CDC), if a bioterrorist attack were to happen, bacillus anthracis, the bacteria that causes anthrax, would be one of the biological agents most likely to be used, since these spores are easily found in nature, can be produced in a lab, and may remain in the environment for a prolonged period. In recent Congressional testimony, Gerald Parker, Associate Dean of Texas A&M’s College of Veterinary Medicine & Biomedical Sciences, indicated that the top three bioterrorist threats were "anthrax, anthrax, and anthrax."

Elusys has previously established a successful track record collaborating with U.S. government agencies including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), the Strategic National Stockpile (SNS) and the Department of Defense (DOD). To date, Elusys has been awarded over $400 million in research and development grants, contracts and procurement orders from BARDA and SNS through ongoing, multi-year partnerships with the U.S. government.

This latest award follows NightHawk’s recent announcement of its planned 500,000+ square foot biodefense-focused biologics biomanufacturing facility in Manhattan, Kansas, which is being designed to scale production of ANTHIM, among other uses.

About ANTHIM
Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

ANTHIM (obiltoxaximab for injection) is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. ANTHIM is indicated for post-exposure prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax.