Certepetide

Phase 1b/2a open-label trial in the U.S. of certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers BASKING RIDGE, N.J., June 13, 2024 (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, announced today the successful completion of patient enrollment for the pancreatic cancer cohort in the Phase 1b/2a CENDIFOX trial. This investigator-initiated trial, led by Dr. Anup Kasi at The University of Kansas (“KU”) Cancer Center, is evaluating the safety and efficacy of certepetide (formerly LSTA1) in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers. “The successful enrollment of the pancreatic cancer cohort represents another significant step forward in the clinical development of certepetide,” said Dr. Kristen K. Buck, Lisata’s Executive Vice President of Research and Development and Chief Medical Officer. “We are encouraged by the progress of the CENDIFOX trial and look forward to both the completion of enrollment in the remaining two cohorts and the reporting of results.” The open-label CENDIFOX trial is designed to assess the safety and therapeutic effects of combining certepetide with neoadjuvant FOLFIRINOX regimens, with or without panitumumab, across pancreatic, colon, and appendiceal cancers. The study, conducted solely at the KU Cancer Center, aims to enroll a total of 51 patients (21 resectable and borderline resectable pancreatic cancer patients, 15 high-grade colon and appendiceal cancer patients with peritoneal metastasis, and 15 colon cancer patients with oligo-metastatic disease). It will provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. The trial is funded by the KU Cancer Center and Lisata is supplying certepetide. “We are excited to collaborate with Lisata and encouraged by certepetide’s potentially diverse applicability,” said Dr. Anup Kasi, the study’s Principal Investigator at the KU Cancer Center. “We are eager to finish enrolling participants in the remaining study cohorts and to analyze the findings of each group to determine its efficacy.” For more information on the CENDIFOX trial, please visit https://www.clinicaltrials.gov/study/NCT05121038. About Certepetide Certepetide (formerly LSTA1) is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to 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 the potential 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 lead product candidate, certepetide (formerly LSTA1), 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 two years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. 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 certepetide as a treatment for patients with metastatic pancreatic ductal 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 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. Contact: Investors: Lisata Therapeutics, Inc.John MendittoVice President, Investor Relations and Corporate CommunicationsPhone: 908-842-0084Email: jmenditto@lisata.com Media: ICR WestwickeElizabeth ColemanSenior AssociatePhone: 203-682-4783Email: elizabeth.coleman@westwicke.com

Waiver confirms that paediatric studies of certepetide in pancreatic cancer are not needed Significant clinical trial burden and costs avoided due to waiver BASKING RIDGE, N.J., May 20, 2024 (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 it has reached agreement with the European Medicines Agency (the “EMA”) on a Paediatric Investigation Plan (“PIP”) for Lisata’s lead investigational product, certepetide (formerly LSTA1), in pancreatic cancer. The EMA has agreed to a product-specific full pediatric waiver for certepetide in pancreatic cancer. The Paediatric Committee (“PDCO”) of the EMA recommended and the EMA granted a waiver for certepetide for all subsets of the pediatric population for the treatment of pancreatic cancer on the grounds that “pancreatic cancer occurs only in adults.” This waiver removes any requirement for Lisata to conduct clinical studies of certepetide in children in support of an overall marketing authorization application in Europe for pancreatic cancer. It also allows Lisata to focus its development efforts on bringing this therapy to relevant patients with pancreatic cancer as quickly as possible. By eliminating any requirement for pediatric clinical studies in pancreatic cancer, the waiver significantly reduces the clinical trial burden and overall cost of completing development and achieving market registration in Europe. “We are pleased that the European Medicines Agency has confirmed that pediatric studies evaluating certepetide are not needed to support a market authorization application in pancreatic cancer,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “With a waiver in hand, we are now able to streamline our development program as we work toward certepetide’s product registration in Europe. This full waiver is specific to pancreatic cancer and will not affect our commitment to evaluate certepetide in other pediatric solid tumors as required.” In 2007, the European Union implemented the Paediatric Regulation, a landmark change that significantly impacted the development of medicines for children. This regulation aims to increase the research and development of medicinal products; specifically, those applicable to children. A key part of the regulation was the establishment of the PDCO. The PDCO coordinates the EMA's work on pediatric medicines by determining the study(ies) companies must conduct in children as part of their overall development program for Europe. A PIP is a development plan designed to ensure that the necessary data are obtained through studies in children to support the authorization of a medicine for children. In some instances, a PIP waiver by the PDCO for certain conditions is recommended and then granted by the EMA when development of a medicine for use in children is not feasible or appropriate. About Certepetide Certepetide (formerly LSTA1) is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to 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 diminishing the immunosuppressive nature of the tumor microenvironment and inhibiting the metastatic cascade. 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 lead product candidate, certepetide (formerly LSTA1), 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 two years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For more information on the Company, please visit . 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 metastatic pancreatic ductal 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 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. Contact: Investors and Media: Lisata Therapeutics, Inc. John Menditto Vice President, Investor Relations and Corporate Communications Phone: 908-842-0084 Email: jmenditto@lisata.com Media: ICR Westwicke Elizabeth Coleman Senior Associate Phone: 203-682-4783 Email: elizabeth.coleman@westwicke.com