RESEARCH TRIANGLE PARK – Morrisville-based Heat Biologics, a clinical-stage immunotherapy company, has signed a definitive merger agreement to acquire Elusys Therapeutics, a biodefense company that makes a treatment for anthrax, a deadly infectious disease potentially spread by bioterrorism or biowarfare.

“This is an important step in realizing our vision to develop and commercialize new biopharmaceuticals and vaccines for the global biodefense market,” Jeff Wolf, chief executive officer of Heat, said in a news release announcing the acquisition.

Heat Bio CEO Jeff Wolf

Elusys, a privately held company based in Parsippany, N.J., will become a wholly owned subsidiary of Heat if the deal closes as expected in the first quarter of 2022. Under the terms of the agreement, Heat will acquire all outstanding shares of Elusys with no stock or warrants being issued.

Expanding sales of Anthrax antidote

Elusys manufactures Anthim (obiltoxaximab) Injection, a monoclonal antibody that neutralizes the anthrax toxin produced by the bacterium Bacillus anthracis. The therapy is approved to treat inhalation anthrax in the U.S., Canada, Europe and the United Kingdom.

Through ongoing, multi-year partnerships with the U.S. government, Elusys has been supplying Anthim to the U.S. Strategic National Stockpile (SNS) — the government’s repository of critical medical supplies for biowarfare preparedness. To date, Elusys has been awarded over $350 million in research and development contracts and procurement orders from various federal agencies

“Our goal is to expand global sales and leverage our capabilities to supply Anthim worldwide,” Wolf said.

The addition of Anthim, together with Heat’s previously announced RapidVax, a cellular vaccine platform designed to target emerging biological threats, would significantly expand Heat’s infectious disease product portfolio for global biodefense.

“Heat brings significant core expertise and resources to accelerate the production and distribution of Anthim,” said Elizabeth Posillico, chief executive officer of Elusys. “I am very pleased that following the closing of the merger certain key members of the Elusys team will continue to manage and support the Anthim program. I believe Heat’s Biothreat Advisory Board, which includes leading global experts on biodefense, will facilitate the expansion of the product’s potential worldwide.”

Anthrax is a major ongoing threat to American biosecurity, said David Lasseter, former deputy assistant secretary of defense for countering weapons of mass destruction and a member of Heat’s Biothreat Advisory Board.

“Anthrax is the deadliest bioterrorism threat to ever hit American soil, and that threat continues to this day from foreign state actors and others,” he said.

It has been used as a weapon around the world and has significant potential for mass casualties. Inhalation anthrax is the most serious form and can kill quickly if not treated immediately.

“Anthim is a key medical countermeasure for treatment of inhalation Anthrax and is currently stockpiled at strategic locations throughout the U.S. as part of SNS,” Lasseter said. “I and my fellow Biothreat Advisory Board members look forward to working with Elusys to expand the supply of Anthim globally to meet this deadly threat.”

Additional details about the Elusys acquisition will be outlined in a Form 8-K that Heat will file with the Securities and Exchange Commission and will also be available on the company’s website.

Expanding facilities, staff

Heat announced this summer that it would double the size of its R&D facilities in Morrisville to about 15,000 square feet to better support its drug-development programs. The company also said it expected to expand its 23-person staff.

In August the company announced the launch of its wholly owned subsidiary, Skunkworx Bio, focused on rapid drug development by identifying miniature proteins that bind to critical domains of druggable targets.

Heat was spun out of the University of Miami in 2008 and relocated to an office at the North Carolina Biotechnology Center’s Landing Pad in 2011. It subsequently received various support from the Biotech Center, including a $250,000 loan when it was trying to raise $4.4 million in capital.

The company raised about $25 million in an initial public offering of stock in 2013. Its shares are traded on the Nasdaq stock market under the ticker symbol HTBX.

Heat is focused on developing first-in-class therapies and vaccines to modulate the immune system. Its gp96 platform, based on the heat shock protein gp-96, is designed to activate immune responses against cancer or infectious diseases.

The company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.

(C) N.C. Biotech Center

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