Humanetics Selects Lifecore Biomedical to Deliver CDMO Services Supporting Development of BIO 300 for the Prevention of Acute Radiation Syndrome
Humanetics' Novel Radioprotective Agent Being Developed with Funding from Department of Defense as Radiation Medical Countermeasure (MCM)
Lifecore to Carry Out Tech Transfer and Analytical Method Activities, including Filling of Pilot Batch
CHASKA, Minn. and MINNEAPOLIS, March 17, 2025 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ:LFCR) ("Lifecore"), a fully integrated contract development and manufacturing organization ("CDMO"), and Humanetics Corporation ("Humanetics"), an advanced clinical-stage pharmaceutical company, today announced that Humanetics has selected Lifecore to provide a range of CDMO services to support the continued development of BIO 300 for the prevention of acute radiation syndrome. Under the terms of the agreement, Lifecore will conduct technology transfer of the existing fill and finish process for BIO 300, including formulation development, gap assessment, and filling of a pilot batch. Lifecore will also undertake analytical method work including feasibility assessments designed to estimate future development work for the product candidate.
"This relationship represents another important example of the momentum that we are generating at Lifecore as we execute against our strategic growth plan. Humanetics' BIO 300 is the exact type of promising, cutting-edge biopharmaceutical product that we strive to support, and we are gratified to have been selected by the company to provide these services," said Paul Josephs, chief executive officer of Lifecore. "Additionally, this collaboration between two Minnesota-based life science companies helps shine a spotlight on the impressive medical innovation that is coming out of our state, and we are thrilled to be able to support the important work being advanced by Humanetics."
"We are excited about working with Lifecore in our own backyard, showcasing the exceptional talent and innovation Minnesota has to offer," said Ronald Zenk, chief executive officer of Humanetics. "Results of this collaboration will help provide critical protection against exposure to radiation for warfighters, First Responders and civilian populations worldwide."
In addition to the acute radiation syndrome program, BIO 300 is currently in late-stage clinical development for the mitigation of impaired pulmonary function in COVID-19 patients recently discharged from the hospital. Humanetics recently announced promising data from a Phase 2 clinical trial of BIO 300. The compound is also in development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy.
Acknowledgement
The U.S. Army Medical Research Acquisition Activity, 808 Schreider Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work was supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $5,132,520 through the Peer Reviewed Medical Research Program under Award Number W81XWH-22-1-0516. Opinions, interpretations, conclusions, and recommendations are those of the author(s) and are not necessarily endorsed by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense.
About Lifecore Biomedical
Lifecore Biomedical, Inc. (NASDAQ:LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the company, visit Lifecore's website at www.lifecore.com.
About Humanetics Corporation
Humanetics is an advanced clinical-stage pharmaceutical company engaged in the accelerated discovery, development, and commercialization of proprietary drugs in markets with urgent and unmet needs, with a focus on medical countermeasures, radiation modulators for oncology and inflammatory lung diseases. For more information, visit www.humaneticscorp.com.
Important Cautions Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as "anticipate", "estimate", "expect", "project", "plan", "intend", "believe", "may", "might", "will", "should", "can have", "likely" and similar expressions are used to identify forward-looking statements. In addition, all statements regarding our anticipated future operating and financial expectations, customer opportunities and relationships are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, as the company's ability to successfully enact its business strategies, including with respect to installation, capacity generation and its ability to attract demand for its services, and its ability expand its relationship with its existing customers or attract new customers; the impact of inflation on Lifecore's business and financial condition; changes in business conditions and general economic conditions both domestically and globally, including rising interest rates and fluctuation in foreign currency exchange rates; Lifecore's ability to access sufficient capital to fund its business strategies; and other risk factors set forth from time to time in Lifecore's SEC filings, including, but not limited to, the Annual Report on Form 10-K for the year ended May 26, 2024 (the "2024 10-K"). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in the 2024 10-K. Forward-looking statements represent management's current expectations as of the date hereof and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.
Lifecore Biomedical, Inc. Contact Information:
Vida Strategic Partners
Stephanie Diaz (Investors)
415-675-7401
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Tim Brons (Media)
415-675-7402
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Ryan D. Lake (CFO)
Lifecore Biomedical
952-368-6244
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