Lisata Therapeutics(US:LSTA)2025-11-06 21:16Clinical Trial Results - Certepetide has shown a 41.5% overall response rate (ORR) across all doses in a Phase 1b/2a study for metastatic pancreatic ductal adenocarcinoma (mPDAC) patients[121]. - The median overall survival (mOS) for the certepetide-treated group in the ASCEND trial was 12.68 months, compared to 9.72 months for the placebo group[122]. - The median progression-free survival (mPFS) was 7.5 months for the certepetide-treated group in the ASCEND trial, compared to 4.7 months for the placebo group[122]. - Certepetide is currently being evaluated in multiple Phase 2 clinical studies globally for various solid tumor types[115]. - The ASCEND trial is a double-blind, randomized, placebo-controlled study evaluating two dosing regimens of certepetide in mPDAC patients[122]. - The drug has demonstrated favorable safety and tolerability profiles in ongoing clinical trials[119]. - Certepetide is designed to enhance the delivery of anti-cancer therapies by modifying the tumor microenvironment and improving drug penetration[120]. Financial Performance - The net loss for the three months ended September 30, 2025, was $4.2 million, an improvement from a net loss of $4.9 million in the same period in 2024[127]. - For the nine months ended September 30, 2025, revenue totaled $70 thousand, an increase from $0 for the same period in 2024[133]. - Net loss for the nine months ended September 30, 2025, was $13.6 million, an improvement from a net loss of $15.4 million in 2024[132]. Operating Expenses - Operating expenses decreased by $0.9 million or 17.3% to $4.4 million for the three months ended September 30, 2025, compared to $5.3 million for the same period in 2024[129]. - Operating expenses decreased by $2.3 million or 12.9%, totaling $15.2 million for the nine months ended September 30, 2025, compared to $17.5 million in 2024[134]. - General and administrative expenses were approximately $8.4 million for the nine months ended September 30, 2025, down $0.7 million or 7.6% from $9.1 million in 2024[135]. Research and Development Expenses - Research and development expenses were approximately $2.0 million for the three months ended September 30, 2025, a decrease of 22.9% from $2.5 million in the same period in 2024[130]. - Research and development expenses were approximately $6.8 million for the nine months ended September 30, 2025, a decrease of $1.6 million or 18.7% from $8.4 million in 2024[135]. Cash and Liquidity - Cash and cash equivalents as of September 30, 2025, were approximately $19.0 million, with working capital of approximately $17.0 million[139]. - Net cash used in operating activities was $12.7 million for the nine months ended September 30, 2025, compared to $14.8 million in 2024[140]. - Cash provided by investing activities totaled $15.1 million for the nine months ended September 30, 2025, primarily from net sales of marketable securities[143]. - The company expects to use existing cash balances and other means to meet short and long-term liquidity needs, including potential issuances of debt or equity securities[147]. - The company issued 197,980 shares of common stock under the ATM Agreement for net proceeds of $600,663 during the nine months ended September 30, 2025[148].