Lisata Therapeutics, Inc. Q3 FY2024 earnings call

• David Mazzo discussed progress in advancing certepetide in combination with anticancer agents for solid tumors and initiated preclinical investigation of certepetide for endometriosis.
• Kristen Buck explained certepetide's mechanism to target stroma and tumor microenvironment, its regulatory designations (orphan drug, Fast Track, rare pediatric disease), and provided updates on clinical trials like ASCEND, BOLSTER, CENDIFOX, etc.
• James Nisco provided financial results overview, noting R&D and G&A expense changes, and cash position.

For the 3 months ended September 30, 2024, operating expenses totaled $5.3 million (down 10.5% from $6 million in Q3 2023). Research and development expenses were $2.5 million (down 24.8% from $3.4 million in Q3 2023) due to reduced clinical research organization expenses and lower equity expense. General and administrative expenses were $2.8 million (up 8.1% from $2.6 million in Q3 2023) primarily due to higher consulting expenses. Net losses were $4.9 million in Q3 2024 (down from $5.3 million in Q3 2023). As of September 30, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $35.9 million, and believes this will fund operations into early 2026.

• The company believes its cash will fund current proposed operations into early 2026, covering anticipated data milestones from ongoing and planned clinical trials.
• Anticipates a data-rich period starting soon and looks forward to market reaction to upcoming data from certepetide trials.

• Forward-looking statements involve risks and uncertainties regarding operations and future results. Actual results may differ from forward-looking statements. Risks include clinical trial timelines, regulatory approvals, and market perception of share price.

Q: Sarah from H.C. Wainwright asked about enrollment in the GBM study.

A: David Mazzo said the GBM trial had a slower start due to site delays, but Estonian site has 5 patients and Latvian sites coming online.

Q: Steve Brozak from WBB Securities asked about endometriosis potential and trial enrollment.

A: Kristen Buck explained endometriosis mechanism and David Mazzo/ Kristen Buck discussed enrollment in ASCEND and BOLSTER trials.

Q: Pete Enderlin from MAZ Partners asked about prioritizing collaborations.

A: David Mazzo talked about prioritizing trials based on data timelines, unmet need, and complementary mechanisms; Valo collaboration due to in-house expertise.

Q: Will Hidell from Brookline Capital Markets asked about Cohort A data for ASCEND trial.

A: David Mazzo said to expect PFS, OS, response rates from the protocol, focusing on OS and response rates for next steps.