Sagimet Biosciences (SGMT) TD Cowen 46th Annual Health Care Conference summary

Strategic direction and development plans

• Focus on combination therapy for MASH, leveraging denifanstat as the foundational FASN inhibitor and combining it with resmetirom for synergistic effects in reducing liver fat, inflammation, and fibrosis.

• Preclinical data show synergy between denifanstat and resmetirom, with animal studies indicating enhanced efficacy; phase I studies in healthy volunteers showed safety and compatibility.

• Selection of resmetirom polymorph for combination is ongoing, prioritizing PK, PD, and solubility, with no anticipated pharmacodynamic differences from the approved form.

• Phase II factorial trial for MASH will test combinations and individual components, with a single, weight-independent, fixed-dose tablet planned for phase III.

• Regulatory discussions with FDA are scheduled for the first half of the year, gating the start of phase II; no additional confirmatory phase IIb is expected before phase III.

Clinical development and safety considerations

• Phase I combination study showed no safety signals, supporting advancement to phase II; safety data for new resmetirom polymorph will be generated as part of phase II.

• Biomarkers such as PDFF, ALT, AST, GGT, and lipids are expected to show early changes in trials.

• No new preclinical toxicology studies are anticipated due to well-characterized safety profiles of both molecules.

• The phase II trial will inform dose selection and combination formulation for phase III, with regulatory input guiding final decisions.

• The phase III proprietary formulation will be a once-daily, co-formulated tablet, independent of patient weight and outside competitor IP.

Acne program and market positioning

• FASN inhibitors are positioned as a novel oral therapy for moderate to severe acne, targeting sebum production and composition, with potential advantages over current standard of care (retinoids, antibiotics).

• Phase I study for acne began in June last year, with readout expected this year and phase II to start by year-end; phase II will be a 12-week, four-arm study mirroring successful Asian partner trials.

• Key endpoints include IGA score reduction and lesion counts, with sebum quantity and composition as relevant biomarkers.

• No genetic differences are expected to impact efficacy between Asian and U.S. populations; learnings from Asian partner's phase II/III studies inform U.S. trial design.

• Patient-reported outcomes will be collected as secondary endpoints, aligning with regulatory expectations.