Humanetics Selects Lifecore Biomedical to Deliver CDMO Services Supporting Development of BIO 300 for the Prevention of Acute Radiation Syndrome

Rhea-AI Summary

Lifecore Biomedical (NASDAQ: LFCR) has been selected by Humanetics to provide CDMO services for the development of BIO 300, a novel radioprotective agent. The collaboration focuses on preventing acute radiation syndrome, with development funded by the Department of Defense.

Under the agreement, Lifecore will handle technology transfer of the fill and finish process for BIO 300, including formulation development, gap assessment, and pilot batch filling. The company will also conduct analytical method work and feasibility assessments for future development.

BIO 300 is currently in late-stage clinical development for multiple applications, including:

• Mitigation of impaired pulmonary function in COVID-19 patients
• Protection of cancer patients from radiation therapy side effects
• Prevention of acute radiation syndrome for warfighters, First Responders, and civilians

The project is supported by a $5,132,520 award from the Department of Defense's Peer Reviewed Medical Research Program.

Positive

• Secured major Department of Defense contract worth $5.13M
• Expanding CDMO service portfolio with radioprotective agent development
• Multiple potential commercial applications for BIO 300 product
• Promising Phase 2 clinical trial data for COVID-19 treatment

Negative

• Product still in development phase with no immediate revenue impact
• Success dependent on clinical trial outcomes and regulatory approvals

Insights

Financial Analyst

The partnership with Humanetics represents a positive business development for Lifecore, securing a new CDMO service contract for BIO 300, a novel radioprotective agent backed by $5.13 million in Department of Defense funding. While the agreement's specific financial terms aren't disclosed, the DoD backing provides program stability and reduced payment risk.

This contract demonstrates Lifecore's execution of its stated growth strategy and ability to win specialized pharmaceutical development work. The multi-indication potential of BIO 300 - being developed for acute radiation syndrome, COVID-19 pulmonary complications, and oncology applications - creates possible service expansion opportunities beyond the initial scope.

For a company with $239 million market capitalization, securing government/defense sector work could open doors to similar contracts. The partnership focuses on Lifecore's core technical capabilities in technology transfer, formulation development, and analytical method work - all high-value CDMO services that typically command stronger margins than basic manufacturing.

While a single contract doesn't transform Lifecore's financial outlook, it represents positive momentum in business development and validates their specialized capabilities in handling complex pharmaceuticals requiring stringent quality standards. The regional connection between these Minnesota-based companies may also enhance Lifecore's visibility for similar partnership opportunities.

Pharmaceutical Industry Expert

This partnership highlights Lifecore's technical capabilities in supporting specialized pharmaceutical products like BIO 300, a radioprotective agent being developed as a radiation medical countermeasure. The scope of work - including technology transfer, formulation development, gap assessment, pilot batch filling, and analytical method work - requires significant expertise, particularly for a product with national security implications.

BIO 300's development across multiple indications creates scientific complexity that benefits from experienced CDMO support. The compound has shown promising clinical progress, with Humanetics recently reporting positive Phase 2 data for its COVID-19 indication. This multi-indication approach spans government/defense applications (radiation syndrome prevention), pandemic response (COVID-19 pulmonary function), and oncology (radiation therapy protection).

Department of Defense involvement provides program stability and validates the strategic importance of the product. For Lifecore, this project demonstrates their ability to compete successfully for complex development projects against larger CDMOs. The radiation countermeasure space represents a specialized niche with ongoing government investment and competition among qualified providers.

The selection of Lifecore for these services indicates Humanetics' confidence in their technical capabilities and quality systems. Successfully executing this project could position Lifecore for additional specialized pharmaceutical development work in areas requiring similar expertise in formulation challenges and analytical method development.

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
sdiaz@vidasp.com

Tim Brons (Media)
415-675-7402
tbrons@vidasp.com

Ryan D. Lake (CFO)
Lifecore Biomedical
952-368-6244
ryan.lake@lifecore.com

FAQ

What is the value of the Department of Defense contract for Lifecore Biomedical's (LFCR) BIO 300 development?

The Department of Defense awarded $5,132,520 through the Peer Reviewed Medical Research Program for BIO 300 development.

What services will Lifecore Biomedical (LFCR) provide for BIO 300 development?

Lifecore will provide technology transfer of fill and finish process, formulation development, gap assessment, pilot batch filling, and analytical method work.

What are the main applications being developed for BIO 300 by Lifecore (LFCR)?

BIO 300 is being developed for acute radiation syndrome prevention, COVID-19 pulmonary function improvement, and protection from radiation therapy side effects in cancer patients.

What stage of development is BIO 300 at for COVID-19 treatment?

BIO 300 is in late-stage clinical development for COVID-19 treatment, with recently announced promising Phase 2 clinical trial data.