LSTA Lisata Therapeutics Inc

Lisata Therapeutics, Inc. (Nasdaq: LSTA) (or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that it has been selected as ‘Specialized BioTherapeutics Company of the Year’ in the fourth 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.

Lisata is recognized for its unique therapeutic approach and streamlined clinical development plans, designed 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, and RNA-based treatments.

By modifying the tumor microenvironment (“TME”), the Company’s investigational product candidate, certepetide, reduces the immunosuppressive nature of the TME, recruits cytotoxic T cells to the tumor, and simultaneously inhibits the metastatic cascade. Certepetide has shown favorable results in enhancing the effectiveness of chemotherapy for pancreatic cancer and has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (“FDA”) for the treatment of pancreatic ductal adenocarcinoma (“PDAC”), along with Orphan Drug designation from the FDA for cholangiocarcinoma (“CCA”), and glioblastoma multiforme (“GBM”). Lisata has also received a Rare Pediatric Disease designation for certepetide in osteosarcoma.

“Winning the ‘Specialized BioTherapeutics Company of the Year’ award is a testament to Lisata’s commitment to advancing the research and development of therapies to provide better outcomes for patients with solid tumors,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. “Thank you to BioTech Breakthrough for this acknowledgment of the entire Lisata team and our partners. We will continue our focus on advancing our robust portfolio with the goal of bringing life-changing treatments to patients as quickly as possible.”

“Lisata is continuing to transform patient lives through the discovery, development, and commercialization of innovative therapies for advanced solid tumors. The Company’s novel product candidate, certepetide, is currently being evaluated in several ongoing clinical trials for the treatment of advanced solid tumors, including PDAC, CCA, GBM, colon cancer, appendiceal cancer, and melanoma,” said Bryan Vaughn, Managing Director of BioTech Breakthrough. “Lisata is also exploring certepetide’s potential in the treatment of non-oncologic applications such as endometriosis. This further demonstrates their commitment to developing cutting-edge therapies that address critical unmet medical needs, making them our well-deserved winner of the ‘Specialized BioTherapeutics Company of the Year.’”

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 14 different countries throughout the world, serving as a global recognition platform that encourages bold ideas and solutions that will shape the future of biotechnology.

About Certepetide

Certepetide is an investigational drug designed to selectively activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer agents more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment, diminishing its immunosuppressive nature and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of various existing and emerging anti-cancer therapies, including chemotherapies, 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 demonstrate its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. 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, osteosarcoma, and cholangiocarcinoma (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 internalizing RGD, or Arginylglycylaspartic acid, (iRGD) 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 early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our 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 melanoma and other solid tumors; 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 a single patient case study 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 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 29, 2024, 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.

Lisata Therapeutics Contact:

Investors:Lisata TherapeuticsJohn MendittoVice President, Investor Relations and Corporate CommunicationsPhone: 908-842-0084Email: jmenditto@lisata.com

Media:ICR HealthcareElizabeth ColemanSenior AssociatePhone: 203-682-4783Email: elizabeth.coleman@westwicke.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0b47bc4c-3623-4fae-ba86-6addc8be007b