Sagimet Biosciences (SGMT) Status update summary

Strategic Focus and Development Plans

• Advancing denifanstat, a novel oral FASN inhibitor, into a U.S. phase III registrational study for moderate to severe acne, with trial initiation expected in the second half of the year, pending IND clearance.

• Recent successful phase II and III trials in China showed denifanstat met all primary and secondary endpoints, supporting confidence in U.S. development; NDA accepted by the NMPA in December 2025.

• Pipeline includes a second oral FASN inhibitor, TVB-3567, in phase I, with phase II proof-of-concept study planned for the second half of the year or 2H 2026, and a topical FASN inhibitor moving toward IND submission.

• $175 million underwritten offering of Series A common stock extends cash runway through 2028, funding all current development programs.

Market Opportunity and Treatment Landscape

• The global acne market is projected to reach $20 billion by 2034, with 50 million U.S. sufferers annually, 10 million of whom have moderate to severe acne.

• Current oral treatments for moderate to severe acne, such as tetracyclines and isotretinoin, have significant side effects and prescribing restrictions, and often require chronic management and multiple annual courses.

• Denifanstat aims to address an underserved population with a once-daily oral option, potentially the first innovative oral acne treatment in over 40 years.

Mechanism of Action and Clinical Data

• Denifanstat targets sebum production and inflammation by inhibiting de novo lipogenesis, a pathway distinct from androgen-targeting therapies; FASN inhibition showed >90% reduction in sebum lipids in Phase 1 trials.

• Phase III China trial in moderate to severe acne (n=480) was double-blind, placebo-controlled, and showed statistically significant improvements in IGA success and lesion count reduction (all p<0.0001).

• 33% of patients achieved clear or almost clear skin, double the placebo rate, with efficacy exceeding typical oral antibiotics.

• Open-label extension data indicated continued improvement in efficacy endpoints beyond 12 weeks.