Lisata Therapeutics, Inc. (Nasdaq: LSTA), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced it has entered into a sponsored research agreement with the University of Cincinnati to investigate Lisata’s novel cyclic peptide product candidate, certepetide, in combination with bevacizumab (a VEGF inhibitor) in a preclinical animal model for the treatment of endometriosis. Bevacizumab has previously demonstrated efficacy in treating endometriosis; however, the required dosage levels are associated with systemic side effects, limiting its use in otherwise healthy young women. Under the agreement, the University of Cincinnati will conduct the research, while Lisata will provide both funding and certepetide.

“We are pleased to have entered into a strategic scientific partnership with the University of Cincinnati to investigate the potential therapeutic applications of certepetide beyond oncology,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “Given the selective targeting of endometrial tissue by certepetide due to its interaction with the surface integrin and neuropilin-1 receptors, we believe the combination of certepetide and bevacizumab could potentially offer an effective and targeted treatment for endometriosis.”

“We're excited to join forces with Lisata to explore the potential of certepetide for endometriosis,” stated Katherine Burns, PhD, Associate Professor at the University of Cincinnati College of Medicine. “By combining our expertise and resources, we aim to uncover insights that could change the treatment and management of endometriosis.”

Endometriosis, a debilitating condition affecting 6.5 million women in the U.S. alone¹, occurs when uterine tissue grows outside the uterus and attaches to other organs. This can result in severe pain, infertility, and other reproductive health issues, as well as nausea, depression, and anxiety. Despite its prevalence, endometriosis remains underdiagnosed and misunderstood, with limited treatment options often requiring invasive surgical procedures. Researchers are actively working to better understand its causes and develop innovative therapies, with the goal of improving the lives of those affected by this condition.
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¹ Ellis, K., Munro, D., & Clarke, J. (2022). Endometriosis Is Undervalued: A Call to Action. Frontiers in global women's health, 3, 902371. https://doi.org/10.3389/fgwh.2022.902371

About Certepetide

Certepetide is an investigational drug designed to selectively activate the C-end rule active transport mechanism in a tissue-specific manner, resulting in systemically co-administered agents more efficiently penetrating and accumulating in the tissue. To date, certepetide has demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing oncology 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. Beyond its promising applications in oncology, certepetide's unique mechanism of action has the potential to be explored in various non-oncology settings. Its ability to selectively target specific tissues could offer new therapeutic possibilities for a range of diseases. 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 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 during 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 University of Cincinnati

Founded in 1819, the University of Cincinnati ranks among the nation’s best urban public research universities. Home to more than 53,000 students, 11,000 faculty and staff and 332,000 alumni, UC combines a Top 35 public research university with a physical setting The New York Times calls “the most ambitious campus design program in the country.” With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, continuing record enrollment, global leadership in cooperative education, a dynamic academic health center and entry into the Big 12 Conference, UC’s momentum has never been stronger. UC’s annual budget tops $1.65 billion and its endowment totals $1.8 billion. Learn more at uc.edu.

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 combined with bevacizumab as a treatment for patients with endometriosis; and certepetide’s potential in oncology and non-oncology applications. 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 because of new information, future events or otherwise.

Lisata Therapeutics Contact:
Investors:
Lisata Therapeutics, Inc.
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com

Media:
ICR Healthcare
Elizabeth Coleman
Senior Associate
Phone: 203-682-4783
Email: elizabeth.coleman@westwicke.com

University of Cincinnati Contact:
Megan Burgasser
Public Information Officer
Phone: 513-545-5616
Email: megan.burgasser@uc.edu