Lisata Therapeutics, Inc. is engaged in the discovery, development, and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Its product, LSTA1, is designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate tumors. It also 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, while normal tissues are unlikely to be affected. The company was founded in 1980 and is headquartered in Basking Ridge, NJ.
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- Lisata Therapeutics has acquired clinical-stage biotech Marea Therapeutics in a stock-for-stock transaction paired with a $225 million private placement financing. - The combined company will focus on Marea's cardioendocrine pipeline, led by MAR001/005 for severe hypertriglyceridemia and MAR002 for acromegaly. - Both programs are expected to report topline data in the fourth quarter of 2027, with Phase 3 registrational studies planned for each. - The oversubscribed financing included RA Capital Management, Forbion, Third Rock Ventures and other institutional investors, funding operations into 2028.
- Lisata Therapeutics has entered a binding term sheet to be acquired by Kuva Labs for $4.00 per share in cash, representing an 85% premium over the most recent closing price. - Stockholders will receive two additional contingent value rights worth $1.00 each, tied to certepetide milestone achievements including rights reversion from Qilu Pharmaceutical and NDA filing. - The acquisition reflects the strategic value of Lisata's clinical pipeline, particularly certepetide, which Kuva previously licensed for use with its NanoMark MR imaging platform technology. - Certepetide is currently in multiple Phase 2 trials across various solid tumors and has received Fast Track and Orphan Drug designations from regulatory authorities.
- Lisata Therapeutics and Catalent announced a global licensing agreement allowing Catalent to incorporate certepetide into antibody-drug conjugates using its SMARTag® platform technology. - The collaboration is based on positive preclinical results showing that incorporating iRGD peptides into ADCs improves efficacy and pharmacokinetics for targeting difficult-to-treat diseases. - Lisata is eligible to receive over $10 million in tiered milestone payments plus revenue sharing, while Catalent gains worldwide rights to develop bioconjugate products containing certepetide and its analogs. - Certepetide is designed to activate a novel uptake pathway that allows anti-cancer drugs to selectively target and penetrate solid tumors more effectively.
- Lisata Therapeutics announced encouraging preliminary results from the CENDIFOX Phase 1/2a trial evaluating certepetide combined with FOLFIRINOX in pancreatic ductal adenocarcinoma patients. - Among 10 patients who completed pre-surgical therapy, the combination achieved a 50% R0 resection rate and 70% pathologic partial response rate with no serious adverse events attributed to certepetide. - The treatment demonstrated promising survival outcomes including 60% two-year overall survival and 12-month median disease-free survival in this difficult-to-treat cancer. - Tumor analysis revealed enhanced immune cell infiltration and increased expression of immune markers, suggesting potential to transform "immune-cold" tumors to "immune-hot" for improved immunotherapy response.
- Lisata Therapeutics has extended its cash runway into the fourth quarter of 2026, providing financial stability to continue research and development operations. - The company established a research agreement with Catalent to explore synergies between its lead drug candidate certepetide and Catalent's antibody drug conjugate platform. - CEO David J. Mazzo reported progress on multiple clinical and corporate milestones during the Q2 2025 earnings call, demonstrating the company's commitment to advancing its therapeutic pipeline.
- Lisata Therapeutics and WARPNINE completed enrollment in the Phase 1b/2a iLSTA trial evaluating certepetide in combination with standard-of-care therapy for locally advanced pancreatic ductal adenocarcinoma. - Updated preliminary data presented at ESMO-GI demonstrated a 60% overall response rate and 100% disease control rate, with 13 of 20 participants showing partial response and one complete response. - The study represents the first evaluation of certepetide in locally advanced non-resectable pancreatic cancer, an earlier disease stage where immunotherapy has been largely ineffective. - Certepetide is designed to enhance tumor penetration of co-administered anti-cancer drugs and has received multiple regulatory designations including Fast Track and Orphan Drug status.
- Lisata Therapeutics received a new U.S. composition of matter patent for certepetide extending intellectual property protection through March 2040, with potential for further extension. - The patent covers certepetide's chemical structure, pharmacokinetic properties, manufacturing methods, and applications for treating solid tumor cancers. - Certepetide is an investigational cyclic peptide designed to enhance tumor penetration of co-administered anti-cancer drugs and has demonstrated favorable safety and clinical activity in pancreatic cancer trials. - The patent provides exclusive manufacturing and selling rights, strengthening Lisata's negotiating position with potential partners and delaying generic competition for nearly two decades.
- The NHS in England has approved relugolix combination therapy as the first long-term daily oral treatment for endometriosis, expected to benefit around 1,000 women annually whose symptoms persist despite previous treatments. - Organon discontinued development of OG-6219 after the drug candidate failed its Phase 2 trial in July 2025, despite being acquired for $75 million and previously described as the company's "biggest potential opportunity." - Hope Medicine's HMI-115, a first-in-class monoclonal antibody targeting the prolactin receptor, reported positive interim Phase II results and received Breakthrough Therapy Designation from China's NMPA. - Multiple companies including TiumBio, Lisata Therapeutics, and Gynica are advancing novel therapeutic approaches through various clinical trial phases, representing diverse mechanisms of action for endometriosis pain management.
- Lisata Therapeutics' certepetide demonstrated significant improvements in progression-free survival and response rates when combined with standard chemotherapy in metastatic pancreatic cancer patients. - The ASCEND Phase 2b trial's Cohort B showed 60.8% six-month progression-free survival for certepetide-treated patients versus 25% for placebo, with median progression-free survival of 7.5 months versus 4.7 months. - The dual-dose regimen achieved a 45.2% objective response rate compared to 19% for placebo, supporting continued development of this novel tumor-penetrating therapy.
- The critical limb ischemia (CLI) market is expected to grow from $1.4 billion in 2024 to $2.5 billion by 2035, with a CAGR of 6.66%, fueled by advances in early detection technologies and personalized medicine approaches. - Novel therapies in development include oxygen carriers (YQ23), autologous stem cell treatments (ASCT-01, CLBS12, ACP-01), and cell-based therapies (REX-001), all aimed at promoting angiogenesis and improving tissue perfusion in ischemic limbs. - The United States represents the largest CLI market, with significant growth driven by FDA regulatory support through fast-track designations and regenerative medicine advanced therapy approvals for innovative treatments.
