Lisata Therapeutics Announces Research License with Catalent

BASKING RIDGE, N.J., April 15, 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 that the Company has entered into a research license with Catalent, Inc. ("Catalent") to evaluate, in a preclinical setting, the efficacy of Lisata's iRGD cyclic peptide product candidate, certepetide, as a payload used in the context of Catalent's SMARTag^® antibody-drug conjugate ("ADC") dual-payload technology platform for the treatment of difficult-to-treat-diseases, including advanced solid tumors.   Under the terms of the agreement, Catalent will assume full responsibility for all research and development expenses and Lisata will provide consulting support. Further, Lisata will receive an upfront payment with the possibility of future considerations contingent upon the results of the preclinical evaluation.

"This is another obvious step in the development of Lisata and certepetide as we see great potential in combining both the technologies and the talents of the scientific teams at Lisata and Catalent to study the combination of certepetide and the SMARTag^® ADC platform. While ADCs utilize monoclonal antibodies to target tumor-specific antigens ensuring precise delivery of cytotoxic drugs to cancer cells while sparing healthy tissues, combining ADC's with certepetide should ensure that the targeted payload penetrates the tumor. The combination of ADCs and certepetide could revolutionize precision oncology delivering targeted therapies deep within tumors for improved efficacy with reduced systemic toxicity. Additionally, the presence of certepetide in the tumor microenvironment (TME) is expected to reduce the immunosuppressive nature of the TME further improving patient response and outcomes to the ADC therapy." stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. "This agreement furthers our strategy of exploiting certepetide's broad applicability and unlocking its full potential. We look forward to seeing results in the near future."

"We are excited to partner with Lisata to investigate how certepetide and the SMARTag^® technology might be used together to make ADCs with enhanced functions," stated Penelope Drake, Head of R&D, Bioconjugates at Catalent. "We are enthusiastic about the potential of this collaboration to deliver innovative treatment options."

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 second quarter of 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 Certepetide

Certepetide (formerly LSTA1), an internalizing RGD (arginylglycylaspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered 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.).

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 of the collaboration with Catalent to develop treatment options; the potential efficacy of certepetide as a treatment for patients with solid tumors; our beliefs about the potential uses and benefits of certepetide; 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 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.

Lisata Therapeutics Contact:

Investors:

Lisata Therapeutics

John Menditto

Vice President, Investor Relations and Corporate Communications

Phone: 908-842-0084

Email: [email protected]

Media:

ICR Healthcare

Elizabeth Coleman

Account Supervisor

Phone: 203-682-4783

Email: [email protected]

This press release was published by a CLEAR® Verified individual.