Lisata Therapeutics Wins 2025 BioTech Breakthrough Award for 'Overall BioPharma Solution of the Year'

BASKING RIDGE, N.J. , Nov. 06, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (NASDAQ:LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced it is the recipient of "Overall BioPharma Solution of the Year" in the fifth annual BioTech Breakthrough Awards program conducted by BioTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe. This marks the second consecutive year Lisata has been honored with a BioTech Breakthrough Award.

Lisata is recognized for its unique therapeutic approach and focused clinical development plans, designed to produce products to address the unmet medical needs of patients with advanced solid tumors. Through its proprietary CendR Platform^® technology, which enables more effective tumor-targeted and tissue-penetrating delivery of anti-cancer drugs by activating the CendR transport mechanism, Lisata aims to improve the efficacy of existing standards-of-care and emerging anti-cancer therapies, including cytotoxics, immunotherapies, RNA-based treatments, and antibody-drug conjugates (ADCs).

Over the past 12 months, Lisata has achieved remarkable clinical results across multiple trials, notably observing complete responses in indications where such outcomes are extremely rare. The ASCEND Phase 2b trial in metastatic pancreatic ductal adenocarcinoma delivered positive preliminary results, with data from the high dose group demonstrating a six-month progression-free survival of 60.8% versus 25% for placebo and an objective response rate of 45.2% compared to 19% in placebo. Additionally, the iLSTA trial in locally advanced, non-resectable pancreatic cancer achieved unprecedented results for a therapy containing an immunotherapy, with a 60% overall response rate and 100% disease control rate, including one complete response. These outcomes validate certepetide's ability to enhance both chemotherapy and immunotherapy effectiveness while maintaining an attractive safety profile.

"Winning the ‘Overall BioPharma Solution of the Year' award further validates Lisata's core mission and the groundbreaking potential of our CendR Platform^® to revolutionize the treatment of solid tumors and other diseases," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "This recognition belongs to the entire Lisata team and our partners who are dedicated to developing therapies that offer significantly better outcomes for patients."

The biotechnology sector is rapidly transforming the future of healthcare, agriculture, and life sciences – reshaping one of the world's most critical and dynamic industries. From groundbreaking gene therapies and advanced biologics to precision medicine, sustainable bio-manufacturing solutions, and more biotechnology is driving greater innovation, efficiency and global impact in improving human health and advancing scientific progress.

The mission of the annual BioTech Breakthrough Awards program is to conduct the industry's most comprehensive analysis and evaluation of the world's top companies, solutions and products in the life sciences and biotechnology markets today. This year's program attracted thousands of nominations from over 15 different countries throughout the world, serving as a global recognition platform that encourages bold ideas and solutions that will shape the future of biotechnology.

"Lisata Therapeutics exemplifies true breakthrough innovation in biopharma. A persistent challenge in oncology is the effective delivery of anti-cancer drugs to solid tumors, which are often heavily fortified by a dense extracellular matrix and an immunosuppressive TME. Limited drug penetration, off-target safety problems, and insufficient efficacy have resulted in mediocre patient outcomes across a range of aggressive cancers," stated Bryan Vaughn, Managing Director, BioTech Breakthrough. "Lisata's CendR Platform^® represents a paradigm shift in the treatment of solid tumors, which has already demonstrated favorable safety, tolerability, and activity in clinical trials. Lisata Therapeutics is our choice for ‘Overall BioPharma Solution of the Year!'"

About Certepetide

Certepetide (formerly LSTA1), an internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or conjugated anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

About Lisata Therapeutics

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata's cyclic peptide product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform^® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into the first quarter of 2027, encompassing anticipated data milestones from its ongoing clinical trials. For a comprehensive overview of certepetide's mechanism of action, please view our informative short film. For more information on the Company, please visit www.lisata.com.

About BioTech Breakthrough

Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the BioTech Breakthrough Awards program is devoted to honoring excellence in life science and biotechnology solutions, services and companies. The BioTech Breakthrough Awards provide public recognition for the achievements of biotechnology companies and products in categories including BioPharma, Genomics, Therapeutics, Immunology, Food Science and BioAgriculture, and more. For more information visit BioTechBreakthroughAwards.com.

Tech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact. Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose.

Forward-Looking Statements

This communication contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company's clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with solid tumors; our beliefs about the potential uses and benefits of certepetide; the potential of the collaboration with Catalent to develop new treatment options; the expected expiration of our patents for certepetide; our ability to obtain patent term extension on our U.S. composition of matter patent; statements relating to Lisata's continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata's capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata's product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from preclinical or preliminary data are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research, preclinical studies, and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata's product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata's clinical programs, Lisata's ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata's scientific studies, Lisata's ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata's markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata's Annual Report on Form 10-K filed with the SEC on February 27, 2025, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:

Media and Investors:

Lisata Therapeutics

John Menditto

Vice President, Investor Relations and Corporate Communications

Phone: 908-842-0084

Email: [email protected]

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