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Jun 30, 2025
Sagimet Biosciences Q2 2025 Earnings Report
Estimated EPS:-$0.49
44.1% YoY
Key Takeaways
Sagimet Biosciences reported a net loss of $10.4 million for Q2 2025, an increase from $8.1 million in the same period last year. The company's cash, cash equivalents, and marketable securities stood at $135.5 million. Key developments include positive Phase 3 results for denifanstat in acne in China and the initiation of a Phase 1 trial for TVB-3567 for acne in the U.S.
Denifanstat met all primary and secondary endpoints in its Phase 3 clinical trial for moderate to severe acne in China, conducted by license partner Ascletis.
Sagimet initiated a first-in-human Phase 1 clinical trial for TVB-3567, a second FASN inhibitor, for acne in the U.S.
The company plans to initiate a Phase 1 clinical trial in 2H 2025 to evaluate the pharmacokinetics and tolerability of a combination of denifanstat and resmetirom for MASH.
Research and development expenses increased to $7.2 million in Q2 2025 from $6.3 million in Q2 2024, reflecting increased clinical trial activities.
Forward Guidance
Sagimet Biosciences anticipates initiating a Phase 1 clinical trial for a denifanstat and resmetirom combination in the second half of 2025, with data expected in the first half of 2026. Contingent on regulatory discussions and Phase 1 results, the company aims to start a Phase 2 program for TVB-3567 in moderate to severe acne patients in 2026.
Positive Outlook
- Planned initiation of Phase 1 clinical trial for denifanstat and resmetirom combination in 2H 2025, targeting MASH.
- Anticipated data readout for denifanstat and resmetirom combination in 1H 2026.
- Potential to start Phase 2 program for TVB-3567 in moderate to severe acne patients in 2026.
- Continued advancement of FASN inhibitors for multiple disease states.
- Positive Phase 3 results for denifanstat in acne in China, supporting the mechanism of action.
Challenges Ahead
- Phase 2 program for TVB-3567 is contingent on discussions with regulatory authorities and the outcome of the Phase 1 trial.
- No specific revenue guidance provided, indicating continued reliance on R&D activities.
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