Lisata regains full development rights to certepetide in the Greater China RegionBASKING RIDGE, N.J., Jan. 27, 2026 (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 mutually terminated the February 2021 Exclusive License and Collaboration Agreement with Qilu Pharmaceutical Co., Ltd. (“Qilu”). The or ...

Company Overview - Lisata Therapeutics is a clinical stage pharmaceutical company focused on developing innovative therapies for cancer and other serious diseases[8] - The company's mission is to rapidly develop and commercialize innovative treatments that improve outcomes for patients with cancer or other serious diseases[10] - Lisata has a proprietary field-leading technology with global IP protection extending beyond 2040[12] - The company projects multiple product and business milestones over the next 12 months[12] - Lisata has existing partnerships that validate its platform technology, with potential for many others[12] - The company's cash runway extends into 1Q 2027 with no debt[12] Certepetide Development and Clinical Trials - Certepetide is designed to optimize solid tumor treatment by converting tumor stroma, reducing immunosuppression, and inhibiting metastasis[23, 24] - In mPDAC, two Phase 1b/2a trials showed that Certepetide plus SoC chemotherapy improved overall survival[73] - In the ASCEND Phase 2b study, Cohort A showed a median overall survival of 12.68 months with Certepetide + SoC compared to 9.23 months with Standard of Care[87] - In the ASCEND Phase 2b study, Cohort B showed a median PFS of 7.46 months with Certepetide + SoC compared to 5.29 months with Standard of Care, nearing statistical significance (HR 0.61, p=0.09)[91, 92] - The iLSTA Phase 1b/2a trial in locally advanced PDAC with chemo & IO showed an Overall Response Rate of 69% in Cohort 3[110] Financial Position - As of June 30, 2025, Lisata had $22 million in cash and investments[140]

Core Points - Lisata Therapeutics has received a new composition of matter patent for certepetide, extending IP protection until March 2040, with potential for further extension [1][2] - The patent secures exclusive rights to certepetide, preventing others from manufacturing or selling the drug, thus significantly enhancing the company's IP portfolio [2][3] - The CEO of Lisata highlighted that this patent milestone boosts the value of certepetide and the company, delaying generic competition for nearly two decades and supporting commercialization efforts [3] Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [5] - Certepetide is designed to enhance the delivery of anti-cancer drugs to solid tumors by activating a novel uptake pathway, showing promise in improving treatment efficacy [4][5] - The company has established significant partnerships and expects to announce multiple milestones in the next 1.5 years, with sufficient capital projected to fund operations into Q4 2026 [5]

Core Insights - The ASCEND Phase 2b trial shows promising preliminary data for certepetide in treating metastatic pancreatic cancer, with positive signals in progression-free survival and objective response rates compared to placebo [1][2][6] - Cohort B data supports the findings from Cohort A, indicating a treatment effect and an attractive safety profile for certepetide [1][6][8] - Full study data from both cohorts is expected later this year, which may provide further insights into the efficacy of certepetide [7] Study Design and Results - The ASCEND trial is a double-blind, randomized, placebo-controlled study involving 158 patients, comparing standard-of-care gemcitabine and nab-paclitaxel with or without certepetide [3] - Cohort A utilized a single dose of 3.2 mg/kg of certepetide, while Cohort B included an additional dose administered four hours later [3] - Preliminary results from Cohort B indicate a six-month progression-free survival of 60.8% for the certepetide group versus 25% for the placebo group, with median progression-free survival of 7.5 months compared to 4.7 months [5] Clinical Significance - The addition of certepetide resulted in a clinically meaningful improvement in both progression-free survival and objective response rates for patients with metastatic pancreatic ductal adenocarcinoma [6] - The objective response rate was 45.2% for the certepetide group compared to 19% for the placebo group, and median overall survival was 10.32 months versus 9.23 months [5] Industry Context - Pancreatic cancer has a poor prognosis, being the sixth leading cause of cancer mortality globally, with a five-year survival rate of only 13%, highlighting the need for new treatment options [9] - Certepetide is designed to enhance the delivery of anti-cancer drugs to solid tumors and has shown favorable safety and tolerability in clinical trials [12][13]

Company Overview - Lisata Therapeutics is a clinical-stage therapeutics company developing a novel solid tumor targeting and penetration technology with tumor microenvironment (TME) modifying properties[7] - The company's mission is to enhance the treatment benefits of existing and emerging therapies for solid tumors without additional side effects[9] - Lisata has a cash runway extending into 3Q2026 with no debt, funding current clinical programs[11] Certepetide Technology and Partnerships - Certepetide is designed to optimize solid tumor treatment by converting tumor stroma, reducing TME immunosuppression, inhibiting metastasis, and working with any modality of anti-cancer therapeutics[23] - Lisata has existing partnerships with Qilu Pharmaceutical, Kuva Labs, and Valo Therapeutics, with potential for additional partnerships[25] - Qilu granted exclusive rights in China, Taiwan, Hong Kong and Macau, Lisata collected $15 million in milestones to date, with potential for additional $221 million in milestones plus royalties[27] Clinical Development and Regulatory Designations - Certepetide has FDA Fast Track Designation for pancreatic cancer, potentially eligible for Accelerated Approval, Priority Review and Rolling Review[93] - Certepetide has FDA Rare Pediatric Disease Designation for Osteosarcoma, eligible for Priority Review Voucher upon approval, vouchers have sold recently for $75-$100 million[94] - Lisata is pursuing rapid global registration in mPDAC, initially combined with gemcitabine/nab-paclitaxel standard-of-care (SoC)[67] Clinical Trial Data - Two Phase 1 clinical trials (CEND1-001 in Australia and CEND1-201 in China) demonstrate that certepetide plus SoC chemotherapy improves overall survival in metastatic PDAC[90] - ASCEND Phase 2 trial Cohort A data demonstrate positive trend in overall survival, including 4 complete responses observed in certepetide treatment group compared to none in placebo group[90] - In ASCEND Phase 2 trial Cohort A, the median overall survival was 1268 months for the Certepetide arm compared to 972 months for the Placebo arm[86]