Lisata Therapeutics, Inc. Q2 FY2025 earnings call

• Business highlights: Signed research agreement with Catalent exploring synergies between certepetide and their antibody drug conjugate platform; formed strategic alliance with GATC Health using their MAT AI platform for drug development. - Clinical milestones: Preliminary results from ASCEND and iLSTA trials were encouraging. - Clinical trials update: ASCEND trial details, BOLSTER trial progress, CENDIFOX trial enrollment completion, iLSTA trial enrollment complete, glioblastoma study initiated. - Collaborations: Research license with Catalent and strategic collaboration with GATC Health. - Intellectual property: US Patent and Trademark Office issued new composition of matter patent for certepetide, extending protection until March 2040.

For the 3 months ended June 30, 2025, revenue totaled $70,000 from an upfront license fee related to a research license agreement with Catalent, Inc. Operating expenses for the same period were $4.9 million, a decrease of $0.6 million (10.6%) from $5.5 million in Q2 2024. Research and development expenses were $2.3 million (down from $2.6 million in Q2 2024), general and administrative expenses were $2.7 million (down from $2.9 million in Q2 2024). Net losses were $4.7 million in Q2 2025, compared to $5 million in Q2 2024.

• Available funds: Cash, cash equivalents, and marketable securities as of June 30, 2025, were approximately $22 million, and available funds are expected to support current operations into the fourth quarter of 2026. - Phase III trial: Begun preparation for Phase III protocol initiation, with capital acquisition as a gating factor. - Spending expectations: Spending may modestly decrease over time as ongoing clinical trials wrap up, depending on Phase III initiation, BOLSTER trial results, and other product advancements.

• Forward-looking statements involve risks and uncertainties. - Actual results may differ materially from those in forward-looking statements as per company's SEC filings. - Time-sensitive information accurate only as of the call date, and the company undertakes no obligation to revise or update statements after the call date.

Q: Could you provide additional insights on the Phase III protocol for ASCEND trial?

A: Had end of Phase IIb meeting with FDA, anticipate Phase III trial with 650 to 900 patients, contemplating continuous infusion and 2-dose dosing arms.

Q: Do you expect spending to remain the same?

A: Depends on Phase III initiation, BOLSTER trial results, and other product advancements; modest decrease expected as ongoing trials wrap up.

Q: Does the cash projection include future license revenues or other revenues?

A: Projections only include small final contribution from New Jersey NOL sale, no other revenues like license or tax benefits.

Q: Compare US vs China regulatory resistance?

A: Hard to compare as not a Chinese company; FDA has clear guidances, and working with them to move products forward.