Lisata Therapeutics(LSTA) - 2025 Q2 - Quarterly Results

Q2 2025 Business Update and Financial Results Lisata Therapeutics reported Q2 2025 financial results, highlighting clinical development progress and a strong cash position Management Commentary and Financial Outlook Management highlighted Q2 2025 clinical advancements and positive trial results, projecting cash into Q4 2026 - The company's core mission is to utilize its drug candidate, certepetide, across a range of advanced solid tumors and other difficult-to-treat diseases[3] - Positive preliminary results were recently announced from the ASCEND and iLSTA trials, with more data expected through the remainder of 2025 and into 2026[3] - The company's cash runway is projected to extend into Q4 2026, funding all current clinical programs to their next data milestone[1][3] Development Portfolio Highlights The development portfolio focuses on certepetide, an investigational drug with regulatory designations, in global clinical trials, and patent-protected until 2040 - Certepetide is an investigational drug designed to activate a transport mechanism that helps co-administered anti-cancer agents better penetrate and accumulate in tumors[4] - Certepetide has received Fast Track and Orphan Drug designations for pancreatic cancer, and Orphan Drug designations for glioma, osteosarcoma, and cholangiocarcinoma in the U.S[5] - A new U.S. patent (No. 12,351,653) was issued for certepetide, extending its composition of matter patent protection until March 2040[7] Clinical Trials Update Certepetide clinical trials show positive preliminary data from ASCEND and iLSTA, with BOLSTER enrollment completed and CENDIFOX progressing - ASCEND (mPDAC): Preliminary data from Cohort B showed a positive signal in progression-free survival and objective response rate. Final data from both cohorts is expected later in 2025[5][6] - BOLSTER (Cholangiocarcinoma): Completed enrollment for first-line CCA ahead of schedule, accelerating the anticipated topline data readout to Q4 2025. Enrollment in the second-line cohort was stopped at ~20 patients to accelerate data readout[8] - iLSTA (PDAC): Updated interim analyses presented at ESMO-GI Congress showed compelling preliminary data, reinforcing certepetide's potential to enhance immunotherapy effectiveness. Final data is anticipated in Q1 2026[8] - CENDIFOX (Pancreatic, Colon, Appendiceal Cancers): Enrollment is complete across all three cohorts, with data expected in the coming months[8] Partnerships Lisata advances development through partnerships with Catalent, GATC Health for AI, and Qilu Pharmaceutical, with a potential $10 million milestone - A research license with Catalent, Inc. is in place to preclinically evaluate certepetide in combination with Catalent's SMARTag ADC technology[7] - An expanded collaboration with GATC Health Corp aims to use an AI platform to optimize drug discovery, analyze certepetide for new indications, and identify combination therapies[7] - Partner Qilu Pharmaceutical completed enrollment in its Phase 2 trial in China for mPDAC. Progression to Phase 3 will trigger a $10 million milestone payment to Lisata[8] Second Quarter 2025 Financial Highlights Q2 2025 saw $70 thousand revenue, $4.9 million operating expenses, a $4.7 million net loss, and $22.0 million cash projected into Q4 2026 Q2 2025 Key Financial Metrics | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $70 thousand | $0 | +$70K | | Operating Expenses | $4.9 million | $5.5 million | -10.6% | | Net Loss | $4.7 million | $5.0 million | -6.0% | | Cash & Marketable Securities | $22.0 million | N/A | N/A | Statement of Operations Q2 2025 revenue was $70 thousand, operating expenses decreased 10.6% to $4.9 million, resulting in a $4.7 million net loss Q2 2025 vs Q2 2024 Statement of Operations (in thousands, except per share data) | Line Item | Q2 2025 (unaudited) | Q2 2024 (unaudited) | | :--- | :--- | :--- | | Revenue | $70 | $— | | Research and development | $2,253 | $2,601 | | General and administrative | $2,685 | $2,922 | | Total operating expenses | $4,938 | $5,523 | | Net loss | ($4,659) | ($5,044) | | Basic and diluted loss per share | ($0.54) | ($0.61) | - The decrease in R&D expenses was primarily due to reduced patient treatment costs and CRO expenses for the Phase 2a BOLSTER trial and lower manufacturing spend[11] - The decrease in G&A expenses was mainly due to savings from an eliminated employee position and lower consulting and travel expenses[12] Balance Sheet As of June 30, 2025, Lisata reported $22.0 million cash, $25.2 million total assets, $4.4 million liabilities, and $20.8 million total equity Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $21,970 | $31,245 | | Total assets | $25,160 | $35,002 | | Total liabilities | $4,385 | $5,685 | | Total equity | $20,775 | $29,317 |