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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