Sagimet Biosciences Inc. filed a Current Report on Form 8-K dated September 30, 2026, to update information regarding its clinical development and financial strategy. The company attached an updated investor presentation and a press release as exhibits to the filing.
The filing details the status of the company's lead drug candidate, denifanstat, a fatty acid synthase inhibitor. According to the attached presentation, denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for moderate to severe acne vulgaris conducted by its license partner, Ascletis BioScience Co. Ltd., in China. The partner announced in December 2025 that the denifanstat New Drug Application (NDA) for this indication had been accepted by the China NMPA. The presentation notes that during the open-label extension trial (ASC40-304), patients showed further improvement in IGA success and lesion count.
Sagimet disclosed plans to advance denifanstat into a Phase 3 clinical trial in the United States for patients with moderate to severe acne in the second half of 2026. The company also highlighted its follow-on FASN inhibitor, TVB-3567, which received Investigational New Drug (IND) clearance in March 2025. A first-in-human Phase 1 clinical trial for TVB-3567 in acne was initiated in June 2025, with results anticipated in 2026.
Regarding its financial position, the company reported $257.6 million in cash, cash equivalents, and marketable securities as of June 30, 2026. This figure includes proceeds from a $175 million underwritten offering of Series A Common Stock completed in April 2026. The company stated this cash balance is expected to fund current operations through 2028 and through the readout of the denifanstat Phase 3 clinical trial.
In a separate development reported in the filing, Sagimet terminated the prospectus supplement related to its at-the-market (ATM) stock offering on September 30, 2026. The termination was effective immediately, meaning the company will not make any sales of its Common Stock pursuant to the Sales Agreement with Leerink Partners LLC unless a new prospectus is filed. The underlying Sales Agreement remains in full force and effect.
