Sagimet Biosciences (SGMT) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Strategic focus on dermatology and FASN inhibitors

• Enhanced focus on dermatology, particularly moderate to severe acne, leveraging FASN inhibitors as a novel mechanism not seen since Accutane's approval in 1982.

• Denifanstat is positioned as a safer, well-tolerated oral alternative to isotretinoin, targeting a broader patient population.

• The drug addresses three of the four main acne drivers: sebum production, inflammation, and infection.

• Positive data from Chinese partner Ascletis, with 20% placebo-adjusted lesion reduction and strong safety profile, supports U.S. development.

• NDA for denifanstat accepted in China, with regulatory decision expected between October and February.

Clinical trial design and regulatory pathway

• U.S. phase III trial will include adolescents (12–17 years) and adults, following FDA guidance, with endpoints mirroring successful Chinese studies.

• Primary endpoint is IGA success at 12 weeks; open-label extension will focus on long-term safety, especially in adolescents.

• IND filing for phase III is imminent, with study start and recruitment targeted by year-end.

• No major procedural hurdles anticipated; trial design stability and known endpoints facilitate execution.

• U.S. and Australian trials for denifanstat and 3567, respectively, will avoid site overlap to prevent recruitment conflicts.

Patient engagement and compliance strategies

• Adolescent recruitment will involve both patients and parents, with education on the importance of compliance and expected outcomes.

• Open-label extension ensures placebo patients transition to active treatment, mirroring positive results from Chinese studies.

• Communication strategies tailored for adolescents, including mobile-based engagement, are being developed.