Lisata Therapeutics(LSTA) - 2025 Q3 - Quarterly Results

Company Overview - Lisata Therapeutics is a clinical stage pharmaceutical company focused on developing innovative therapies for cancer treatment, with a mission to improve patient outcomes [8][10]. - The company has a cash runway extending into Q1 2027 and operates with no debt, indicating strong financial health [15]. - Lisata's leadership team has extensive experience in global drug development, which is crucial for navigating the complexities of the pharmaceutical industry [12][18]. Product Development and Efficacy - Certepetide, a proprietary cyclic peptide, is designed to optimize solid tumor treatment by converting tumor stroma from a barrier to a conduit for anti-cancer drugs and selectively reducing immunosuppressive T cells [28][29]. - Certepetide improved median overall survival in metastatic pancreatic ductal adenocarcinoma (mPDAC) to 12.68 months compared to 9.23 months for standard of care (SoC) [92]. - In the ASCEND Phase 2b study, Certepetide demonstrated a median progression-free survival (PFS) of 7.46 months versus 5.29 months for SoC, nearing statistical significance (HR 0.61, p=0.09) [96]. - Certepetide showed a 55% improvement in overall survival compared to the historical control of gemcitabine plus nab-paclitaxel [77]. - Certepetide achieved a 45% objective response rate (CR + PR) in Cohort B compared to 19% in the placebo group [101]. - Certepetide demonstrated internal consistency across two Phase 1b/2a trials, supporting its efficacy in mPDAC [79]. - Certepetide demonstrated improved overall survival in metastatic pancreatic ductal adenocarcinoma (mPDAC) compared to standard of care, with median overall survival (mOS) of 10.32 months versus 9.23 months for the control group [107]. - In Cohort B, the median progression-free survival (mPFS) was 7.46 months for Certepetide compared to 5.29 months for placebo, with a hazard ratio (HR) of 0.61 and a p-value of 0.09 [107]. - The overall response rate (ORR) for Certepetide treated patients was 50.0%, significantly higher than the 21.1% for placebo, with 1 complete response observed in the Certepetide group [107]. - Certepetide was well tolerated, with adverse events (AEs) similar to those of standard of care, and the most common AEs included fatigue (73.85% in Cohort A) and nausea (53.85% in Cohort A) [105]. Clinical Trials and Studies - The ASCEND Phase 2b trial for first-line mPDAC has completed enrollment with 158 participants, testing gemcitabine/nab-paclitaxel with certepetide or placebo [189]. - The BOLSTER Phase 2a trial for cholangiocarcinoma has completed enrollment for both first-line and second-line cohorts, with a total of 69 participants [171]. - The CENDIFOX Phase 1b/2a trial for pancreatic, colon, and appendiceal cancers has completed enrollment with 50 participants [171]. - The ILSTA Phase 1b/2a trial for locally advanced, non-resectable PDAC has completed enrollment with 30 participants [171]. - The company is targeting mid-2026 for the final data from the BOLSTER trial, which is expected to be achieved 6 months early [175]. - The primary endpoints included Progression Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS) metrics [193]. - A Phase 1b/2a trial in China (CEND1-201) is evaluating the safety and preliminary efficacy of certepetide in 55 patients with mPDAC, with results expected to contribute to overall survival and disease control rates [193]. - The CENDIFOX trial aims to complete enrollment by Q4 2024, focusing on drug safety and overall response rates [197]. - The intervention arm of the Phase 2b study included 63 patients receiving two IV pushes of certepetide, while the control arm had 29 patients receiving placebo [191]. - The study design includes treatment on days 1, 8, and 15 every 28 days, allowing for consistent monitoring of patient responses [191]. - The trials are being conducted across approximately 30 sites, including locations in Australia and New Zealand [191]. - Preliminary data from the trials was presented at the 2023 ASCO Annual Meeting, indicating ongoing research and development efforts in the field [193]. Strategic Partnerships and Financials - Lisata has established partnerships with organizations such as Catalent, GATC Health Corp., and Qilu Pharmaceutical, which support the development and commercialization of Certepetide [32][34]. - The company is eligible to receive over $10 million in tiered development milestone payments from Catalent, along with revenue sharing on future sales [34]. - Certepetide has a robust intellectual property portfolio, including 25 granted patents and 26 pending patents, with market exclusivity of 7 to 10 years post-approval in the U.S. and EU [30]. - Lisata's strategic partnerships are expected to enhance the development of Certepetide and its combinations with other therapies, potentially leading to significant revenue growth [34]. - The company is exploring additional commercial partnership opportunities to expand the reach of Certepetide in various oncology applications [129]. - As of September 30, 2025, the company has $19.0 million in cash and investments, with no debt, providing a projected cash runway into 2027 [178]. - The company has 8.8 million common shares outstanding and 1.5 million options outstanding, with a weighted average exercise price of $40.52 for warrants [179]. Market Context and Future Outlook - The global cancer burden is projected to increase significantly, with an estimated 35 million new cases and 18.5 million deaths by 2050, highlighting the urgent need for effective cancer therapies [22][23]. - The company anticipates multiple product and business milestones over the next 12 months, indicating a proactive approach to market expansion [13]. - Certepetide's commercial prospects are bolstered by its applicability across various treatment lines for mPDAC, including first-line, second-line, and third-line therapies [123]. - Certepetide's development strategy includes rapid global registration and combination studies with various SoC regimens [71]. - The global Phase 3 trial design for Certepetide has been agreed upon with the FDA, targeting 657 patients and focusing on overall survival as the primary endpoint [134]. - Certepetide has received FDA Fast Track Designation and Orphan Drug Designations, enhancing its regulatory advantages and potential market access [130].