Lisata Therapeutics, Inc. Q3 FY2025 earnings call

• Development milestones: Certepetide achieved encouraging preliminary results in studies like ASCEND, iLSTA, and CENDIFOX. - Business development: Strategic alliance with GATC Health for drug discovery, and nonexclusive global license agreement with Catalent for certepetide use in ADCs. - Clinical trials: ASCEND trial had preliminary positive data; BOLSTER trial enrollment completed ahead of plan; CENDIFOX trial enrollment complete with preliminary positive data; iLSTA trial enrollment complete with positive preliminary data; GBM trial enrolling with ~2/3 of target patients. - Intellectual property: U.S. Patent and Trademark Office issued new patent for certepetide.

No detailed product segment financials with revenue contribution percentages provided. Overall, operating expenses for the 3 months ended September 30, 2025, totaled $4.4 million, down from $5.3 million in 2024. Research and development expenses were $2 million, down from $2.5 million. General and administrative expenses were $2.5 million, down from $2.8 million. Net losses were $4.2 million, down from $4.9 million. Cash and cash equivalents as of September 30, 2025, were approximately $19 million, projecting support for operations into Q1 2027.

• Cash runway: Available funds project support for current operations into Q1 2027. - Future plans: Hopes to increase burn rate by doing more studies to generate more data; plans to seek partners/licensees to fund Phase III trials, leveraging existing licenses and internal efforts.

• Clinical trial timelines: Dependence on investigator-controlled timelines for studies like CENDIFOX. - Market conditions: Macro environment affecting small-cap biotech, limiting buyer interest. - Regulatory uncertainties: Uncertainties in regulatory approvals and compliance affecting development and fundraising.

Q: For CENDIFOX, when approximately should we expect the next Phase IIb data cut? And for the GBM trial, could you provide some color on the enrollment status for the target sample size?

A: On CENDIFOX, can't give precise estimate as it's investigator-controlled; GBM trial is ~2/3 of the way to enrolling 30 patients.

Q: Your cash flow runway to the first quarter of '27, what is that actually -- can you sort of run through what that really includes in terms of expenditures going into 2026?

A: Covers operating expenses and ongoing clinical trial expenses; no Phase III assumption yet.

Q: With the final analysis of the ASCEND data coming relatively soon, could you talk about your thinking for the next steps?

A: Plan to move to Phase III, seeking partners/licensees to fund it, preparing CMC, FDA discussions, etc.

Q: This biotech achievement award, breakthrough award that you got overall is the word used, does that mean that you're the only one that got that?

A: That's the only award with that title.

Q: First, this biotech achievement award... And just following up on a previous question. The -- I guess the burn rate looks like it will be roughly $3 million per quarter for the next 5 quarters. Is it going to be fairly level over that period of time?

A: Hopes burn rate goes up to do more studies; may need to raise capital, but licensing fees could help.