Lisata Therapeutics, Inc. Q4 FY2024 earnings call

• Advancement of certepetide development portfolio for advanced solid tumors and other diseases, with preliminary results from ASCEND and iLSTA trials showing potential. - Preclinical investigation of certepetide for endometriosis. - Regulatory achievements for certepetide including orphan drug, fast track, and rare pediatric designations. - Updates on clinical trials: ASCEND trial's Cohort A results, BOLSTER trial enrollment progress, CENDIFOX trial completion, Qilu Pharmaceutical's Phase 2 trial in pancreatic cancer, iLSTA trial progress, glioblastoma study initiation, and FORTIFIDE trial strategy exploration. - Preclinical collaborations for certepetide in oncology and endometriosis.

For the year ended December 31, 2024, revenue totaled $1 million from an upfront license fee. Operating expenses in 2024 were $23.4 million, a decrease of $2.3 million (8.9%) from 2023's $25.7 million. Research and development expenses in 2024 were $11.3 million, down $1.4 million (11%) from 2023's $12.7 million. General and administrative expenses in 2024 were $12.1 million, a decrease of $0.9 million (6.9%) from 2023's $13 million. Net losses were $20 million in 2024 compared to $20.8 million in 2023. As of December 31, 2024, cash, cash equivalents, and marketable securities totaled approximately $31.2 million.

• 2025 is expected to be a data-rich year with key milestones. - Anticipation of Cohort B data from the ASCEND trial to be akin to Cohort A, including progression free survival and overall survival analysis, with plans for Phase 3 assuming supportive data. - Exploration of alternative strategies to achieve FORTIFIDE trial objectives, focusing on faster and less expensive options.

• Uncertainty in data release timing for Cohort B as controlled by investigators. - Dependence on regulatory and clinical trial outcomes which may not go as planned. - Financial resources required for preclinical collaborations and further development.

Q: Regarding the ASCEND trial Cohort B data, can you give insight into what kind of data we could expect?

A: We expect something akin to Cohort A, including analysis of progression free survival and preliminary/final overall survival.

Q: Regarding the timing of Cohort B data, can you be more specific?

A: Best we can say is likely from second through third quarter of 2025, as controlled by investigators and dependent on abstract submission timelines.

Q: Regarding the Street's reaction to Cohort A results, what did the Street miss or misinterpret?

A: The Street may have misunderstood the nuances of trial design; the full trial results matter, not bits and pieces.

Q: Regarding the Kuva deal, will it lead to future diagnostics for clinical trials?

A: Intention is to use for personalized medicine, identifying patients/tumors susceptible to certepetide for better treatment regimes.

Q: What are pharmaceutical partners looking for in data?

A: Complete trial results, consistency of therapeutic effect and safety, appropriate sizing/powering of Phase 3 protocol, and no untoward safety signals.

Q: Regarding the Fortified trial, can you elaborate on alternative approaches?

A: Considering using imaging techniques and endpoints to derive information in less time and cost than original design.