LSTA Lisata Therapeutics Inc

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 the publication of a case report detailing a complete response in a patient with metastatic gastroesophageal adenocarcinoma patient treated with LSTA1 in combination with the standard-of-care therapy in Oncology & Cancer Case Reports Journal on December 30, 2023.

The case report, entitled “LSTA1 Potentiates Complete Response in Metastatic Gastroesophageal Adenocarcinoma,” which was co-authored by Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata, details a patient with metastatic gastroesophageal adenocarcinoma who achieved a complete response when given LSTA1, Lisata’s lead investigational product, in combination with standard of care (“SoC”) FOLFIRINOX + pembrolizumab. The subject initially underwent months of SoC treatments and achieved a partial response. Upon subsequent addition of LSTA1 to such SoC therapeutic regimen, the subject achieved a complete response, confirmed both radiographically and surgically.

“To observe a complete response in a patient with gastroesophageal adenocarcinoma with bulky metastasis when given LSTA1 in combination with SoC is a reminder to all involved in the development of LSTA1 of our ultimate goal – to identify a treatment that eliminates solid tumors,” stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata. “Despite advances using immunotherapy and chemotherapy as SoC for metastatic disease and the modest survival improvement therein, the long-term prognosis for patients with metastatic gastroesophageal adenocarcinoma cancer remains poor. As detailed in the case report, LSTA1, together with the SoC therapy, demonstrated tumor targeting and penetration-enhancing capability in this patient. As this result implies, LSTA1, when administered in addition to SoC, is expected to improve outcomes for patients with a range of advanced solid tumors.”

“These unprecedented results are beyond gratifying; bolstering our confidence in LSTA1’s potential to completely alter the treatment paradigm for patients with metastatic gastroesophageal adenocarcinoma and other solid tumors,” stated Dr. Andrew Dean, MBChB, MRCP (UK), FRACP, Medical Oncologist, Principal Investigator. “We are increasingly excited to continue investigating LSTA1’s potential.”

To read the published case report, please visit https://www.lisata.com/research-technology/publications/lsta1-potentiates-complete-response-in-metastatic-gastroesophageal-adenocarcinoma/

About LSTA1

LSTA1 is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered (i.e., covalently bound) anti-cancer drugs to penetrate solid tumors more effectively. LSTA1 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. LSTA1 also has the potential to modify the tumor microenvironment, with the objective of making tumors more susceptible to immunotherapies. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies and RNA-based therapeutics. Additionally, LSTA1 has demonstrated favorable safety, tolerability, and activity in clinical trials to enhance delivery of SoC chemotherapy for pancreatic cancer. Lisata is exploring the potential of LSTA1 to enable a variety of treatment modalities to treat a range of solid tumors more effectively.

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 lead product candidate, LSTA1, 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. Based on Lisata’s CendR Platform® Technology, Lisata has already established noteworthy commercial and R&D partnerships. The Company expects to announce numerous clinical study and business milestones over the next two years and has projected that its current business and development plan is funded with available capital through these milestones and into early 2026. For more information on the Company, please visit www.lisata.com.

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 strategy, future operations, future financial position, future revenue, projected expenses and capital, prospects, plans and objectives of management 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 LSTA-1 as a treatment for patients with metastatic gastroesophageal adenocarcinoma 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 March 30, 2023, 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.

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