Humanetics Corp.

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. AcknowledgementThe 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 CorporationHumanetics 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 PartnersStephanie Diaz (Investors)415-675-7401sdiaz@vidasp.com Tim Brons (Media)415-675-7402tbrons@vidasp.com Ryan D. Lake (CFO)Lifecore Biomedical952-368-6244ryan.lake@lifecore.com

MINNEAPOLIS--( BUSINESS WIRE )--Humanetics Corporation (Humanetics) announced today the results of its Phase 2 clinical trial of BIO 300 Oral Suspension (BIO 300) for the mitigation of impaired pulmonary function in COVID-19 patients recently discharged from the hospital. BIO 300 is an oral drug that patients self-administer daily for 12 weeks following hospital discharge. The study compared the lung function, exercise capacity, and quality of life in COVID-19 survivors who received BIO 300 against a placebo group. The trial enrolled 38 participants across multiple U.S. sites ( NCT04482595 ). Rany Condos, MD, a clinical Professor in the Department of Medicine at NYU Grossman School of Medicine and Director of its Post-COVID Program, served as the lead investigator. Patients previously hospitalized with COVID-19 complications and discharged with residual lung complications (e.g., long COVID) were eligible if enrolled within two years of discharge. Multiple pulmonary function assessments and a patient-reported quality of life questionnaire were used to evaluate BIO 300’s efficacy. Although the study fell short of its planned enrollment of 50 participants, the 20 BIO 300-treated participants within the enrolled cohort of 38 exhibited improved lung function and participant-reported quality of life compared to placebo-treated participants. Key Trial Findings: Improvement in Pulmonary Function: Participants who received BIO 300 demonstrated a statistically significant improvement in pulmonary function at 12 weeks, which was maintained at 12 months, as measured by forced expiratory volume in one second (FEV1). Additionally, clear statistical trends for improved pulmonary function were observed in BIO 300-treated participants at 12 weeks, 6 months, and 12 months, as measured by the diffusing capacity of the lung for carbon monoxide (DLCO) and forced vital capacity (FVC). Quality of life: Participants treated with BIO 300 showed a clear trend toward an improved quality of life as measured by the St. George’s Respiratory Questionnaire at 6 months, which was maintained at 12 months. Safety Profile: BIO 300 treatment was well-tolerated, with adverse events consistent with those expected in this patient population. No new safety concerns were identified during the trial. "We are highly encouraged by the results of this clinical trial, particularly the promising trends in pulmonary function improvement among COVID-19 participants treated with BIO 300," said Michael Kaytor, PhD, Vice President of Research and Development at Humanetics. "We are continuing to evaluate the data to refine our understanding of BIO 300’s efficacy in COVID-19 and its potential applications for improving patient outcomes." BIO 300 is also in development as a medical countermeasure for use by the United States Department of Defense and for oncology applications to protect patients from side effects caused by radiation. "As BIO 300 has been shown to mitigate inflammation of the lungs and pulmonary fibrosis caused by radiation, we believe that the same effect can be shown in COVID-19 patients,” said Ronald J. Zenk, Chief Executive Officer at Humanetics. “We are optimistic that this treatment could be a valuable addition to the ongoing efforts to combat long COVID and other conditions with lung inflammation and are committed to evaluating its impact in future studies.” This project was funded by the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health, Department of Health and Human Services, under Contract HHSN272201800011C. 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 .

MINNEAPOLIS--( BUSINESS WIRE )--Humanetics Corporation (Humanetics) announced today the results of its Phase 2 clinical trial of BIO 300 Oral Suspension (BIO 300) for the mitigation of impaired pulmonary function in COVID-19 patients recently discharged from the hospital. BIO 300 is an oral drug that patients self-administer daily for 12 weeks following hospital discharge. The study compared the lung function, exercise capacity, and quality of life in COVID-19 survivors who received BIO 300 against a placebo group. The trial enrolled 38 participants across multiple U.S. sites ( NCT04482595 ). Rany Condos, MD, a clinical Professor in the Department of Medicine at NYU Grossman School of Medicine and Director of its Post-COVID Program, served as the lead investigator. Patients previously hospitalized with COVID-19 complications and discharged with residual lung complications (e.g., long COVID) were eligible if enrolled within two years of discharge. Multiple pulmonary function assessments and a patient-reported quality of life questionnaire were used to evaluate BIO 300’s efficacy. Although the study fell short of its planned enrollment of 50 participants, the 20 BIO 300-treated participants within the enrolled cohort of 38 exhibited improved lung function and participant-reported quality of life compared to placebo-treated participants. Key Trial Findings: Improvement in Pulmonary Function: Participants who received BIO 300 demonstrated a statistically significant improvement in pulmonary function at 12 weeks, which was maintained at 12 months, as measured by forced expiratory volume in one second (FEV1). Additionally, clear statistical trends for improved pulmonary function were observed in BIO 300-treated participants at 12 weeks, 6 months, and 12 months, as measured by the diffusing capacity of the lung for carbon monoxide (DLCO) and forced vital capacity (FVC). Quality of life: Participants treated with BIO 300 showed a clear trend toward an improved quality of life as measured by the St. George’s Respiratory Questionnaire at 6 months, which was maintained at 12 months. Safety Profile: BIO 300 treatment was well-tolerated, with adverse events consistent with those expected in this patient population. No new safety concerns were identified during the trial. "We are highly encouraged by the results of this clinical trial, particularly the promising trends in pulmonary function improvement among COVID-19 participants treated with BIO 300," said Michael Kaytor, PhD, Vice President of Research and Development at Humanetics. "We are continuing to evaluate the data to refine our understanding of BIO 300’s efficacy in COVID-19 and its potential applications for improving patient outcomes." BIO 300 is also in development as a medical countermeasure for use by the United States Department of Defense and for oncology applications to protect patients from side effects caused by radiation. "As BIO 300 has been shown to mitigate inflammation of the lungs and pulmonary fibrosis caused by radiation, we believe that the same effect can be shown in COVID-19 patients,” said Ronald J. Zenk, Chief Executive Officer at Humanetics. “We are optimistic that this treatment could be a valuable addition to the ongoing efforts to combat long COVID and other conditions with lung inflammation and are committed to evaluating its impact in future studies.” This project was funded by the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health, Department of Health and Human Services, under Contract HHSN272201800011C. 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 .