Sagimet updated an investor slide presentation highlighting denifanstat Phase 3 plans for US acne in 2H 2026, clinical data and financial runway.
Key Highlights:
- Updated presentation will be used in investor meetings and is furnished as Exhibit 99.1 to the 8-K.
- Denifanstat met all primary and secondary endpoints in Ascletis Phase 3 acne trial; NDA accepted by China NMPA in Dec 2025.
- Sagimet plans to initiate a US Phase 3 denifanstat trial for moderate‑to‑severe acne in 2H 2026, pending FDA consultation; IND open July 2026.
- TVB-3567 IND cleared Mar 2025; FIH Phase 1 started June 2025 with Phase 2 targeted for 2H 2026 pending results and regulatory feedback.
- $104.5M cash as of 3/31/2026 and $175M Series A offering announced Apr 2026; company expects funding to support operations through 2028 and denifanstat Phase 3 readout.
Original SEC Filing:
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