Lisata Therapeutics Q2 2025: Key Contradictions in ASCEND Trial Insights and Financial Projections

Generated by AI AgentEarnings Decrypt
Friday, Aug 8, 2025 3:14 am ET1min read
Aime RobotAime Summary

- Lisata reported $70K Q2 revenue and $22M cash, extending runway to 2026 Q4 amid 10.6% operating expense reduction.

- ASCEND trial completed Cohort A enrollment with 4 complete responses, while BOLSTER and iLSTA trials accelerated data timelines.

- New certepetide patent (2040 expiry) and collaborations with Catalent/GATC Health strengthen IP and drug discovery capabilities.

- FDA Phase II end discussion and Qilu's parallel trial progress advance regulatory pathways for key programs.

ASCEND trial design and enrollment, spending and financial projections, ASCEND trial data expectations, endometriosis and cilengitide's potential, and ASCEND Cohort A data interpretation are the key contradictions discussed in Therapeutics' latest 2025Q2 earnings call.



Financial Performance and Cash Position:
- reported $70,000 in revenue for Q2 2025, primarily from an upfront license fee with Catalent.
- Operating expenses decreased by $0.6 million or 10.6% year-on-year, with research and development expenses down by $0.3 million and general and administrative expenses down by $0.2 million.
- As of June 30, 2025, the company had $22 million in cash, cash equivalents, and marketable securities, extending its cash runway into the fourth quarter of 2026.
- The decrease in operating expenses and stable cash position are attributed to prudent capital management, cost reduction, and efficiency in trial management.

Clinical Trial Progress:
- The ASCEND trial, a Phase IIb study, completed enrollment in Cohort A and presented preliminary data showing positive trends in overall survival, with 4 complete responses in the certepetide-treated group.
- The BOLSTER trial, a Phase IIa study, completed enrollment ahead of schedule, accelerating the anticipated top-line data readout to Q4 2025.
- The iLSTA trial, a Phase Ib/IIa study, completed enrollment and presented interim data indicating significant RECIST responses and improved overall response rates.
- These advancements in trial progress are due to effective trial management, investigator support, and encouraging preliminary results.

Collaboration and Intellectual Property:
- Lisata entered into a research license with Catalent to evaluate certepetide on Catalent's SMARTag platform and established a strategic collaboration with GATC Health for AI-powered drug discovery.
- The U.S. Patent and Trademark Office issued a new composition of matter patent for certepetide, extending protection until March 2040.
- These collaborations and intellectual property milestones are part of Lisata's strategy to expand its pipeline and secure its intellectual property rights.

Regulatory and Development Milestones:
- The company concluded an end-of-Phase II discussion with the FDA, agreeing on aspects of an acceptable Phase III protocol for certain trials.
- Qilu Pharmaceutical, the licensee in Greater China, completed enrollment in a parallel development program and anticipates data within 12 to 18 months.
- These milestones represent progress in regulatory clearance and development plans, reflecting Lisata's commitment to advancing its pipeline efficiently.

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