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

Strategic focus and clinical development plans

• Enhanced focus on dermatology, particularly moderate to severe acne, leveraging FASN inhibitors as a novel mechanism after decades without innovation in the space.

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

• Upcoming phase III trial in the U.S. will include adolescents (12–17 years) and adults, with endpoints and design closely mirroring successful Chinese studies.

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

• Parallel development of next-generation molecule TVB-3567, with phase II in Australia to avoid site overlap with U.S. phase III.

Clinical data and regulatory milestones

• Chinese partner Ascletis reported consistent phase II and III results: ~20% placebo-adjusted reduction in lesion count and IGA improvement, leading to NDA acceptance in China.

• Regulatory decision in China expected between October and February, serving as a near-term milestone.

• U.S. phase III will replicate Chinese trial design but with a more diverse demographic and adolescent inclusion per FDA guidance.

• Open label extension will focus on long-term safety, especially in adolescents, with education strategies to ensure compliance.

• Safety data from over 1,000 patients at 50 mg daily shows minimal adverse events, supporting FDA's encouragement to include younger patients.

Product differentiation and lifecycle management

• Denifanstat demonstrates a favorable safety profile compared to isotretinoin, with only mild dry skin and dry eye reported at rates similar to placebo.

• TVB-3567 is more potent; phase I will determine dosing and sebum impact, with efficacy and safety to be compared in phase II.

• Topical formulations of both denifanstat and TVB-3567 are in development, targeting the larger mild acne population, with IND and first-in-human studies planned for early 2028.

• Recent financing supports advancement of oral and topical programs for both molecules.

• Patient and parent education, especially for adolescents, will leverage digital communication to maximize trial compliance.