Lisata Therapeutics(US:LSTA)2025-05-09 17:31Company 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]