Sagimet Biosciences (SGMT) investor relations material

Company overview and clinical focus

• Focuses on FASN overexpression as a driver in multiple diseases, with lead program in acne and additional data in liver and tumor indications.

• Lead asset, denifanstat, targets de novo lipogenesis and is advancing to phase III for moderate to severe acne.

• Pipeline includes a second oral FASN inhibitor entering phase II and a topical FASN inhibitor in formulation for mild acne, with first-in-human studies planned for 2028.

• Recent fundraising has positioned the company to advance these programs.

Clinical trial results and design

• Ascletis' phase III trial in China showed significant efficacy for denifanstat in moderate to severe acne, with a 20-point improvement in IGA success over placebo and strong lesion reduction.

• Safety profile was favorable, with mild to moderate dry skin and dry eye as the main side effects, and no serious adverse events.

• Upcoming phase III trial in the US will closely mirror the Chinese design but will include at least 300 adolescents, totaling 800 patients with 2:1 randomization.

• Primary endpoints will follow FDA standards, focusing on IGA/EGSS success and lesion reductions.

Market opportunity and positioning

• US acne market includes 50 million patients, with 10–15 million moderate to severe cases; current treatments are mainly oral antibiotics and topicals, with Accutane reserved for the most severe cases.

• Denifanstat is positioned to replace oral antibiotics and reduce topical use, especially for patients with truncal acne.

• Direct targeting of sebum production differentiates denifanstat from existing therapies.

• Commercial strategy will leverage a hybrid approach, combining direct-to-consumer and targeted dermatology outreach, with little competition expected.