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

Strategic direction and development plans

• Focus is on developing denifanstat as a foundational FASN inhibitor for MASH, with a shift toward combination therapies, particularly with resmetirom, to address unmet needs in advanced liver disease populations.

• Preclinical data show synergistic effects between denifanstat and resmetirom, enhancing anti-inflammatory and antifibrotic outcomes; animal studies demonstrated clear synergy, though human studies are pending.

• The company has licensed 20 novel forms of resmetirom API from Teva, currently evaluating these for optimal pharmacokinetics, pharmacodynamics, and solubility, aiming for a form that avoids IP overlap and is suitable for co-formulation.

• Phase I combination studies showed no safety signals and strong compatibility, supporting advancement to phase II trials.

• A regulatory meeting with the FDA is planned in the first half of the year to finalize phase II trial design, with the expectation to proceed directly to phase III upon successful completion.

Clinical trial design and biomarker strategy

• The phase II factorial study will test combinations against individual components and placebo, with a fixed, weight-independent dose planned for the proprietary phase III formulation.

• Early biomarkers expected to respond include PDFF, ALT, AST, GGT, and lipids, with gene activation and omics also being monitored.

• No new preclinical toxicology studies are anticipated for the new resmetirom polymorph; safety data will be generated as part of phase II.

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

• The phase III formulation will be a single, 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 a mechanism distinct from current standard of care.

• Phase I studies include healthy volunteers and moderate to severe acne patients, focusing on safety, dose finding, and sebum analysis; phase II is planned as a 12-week, four-arm study with top-line data expected in the second half of next year.

• Clinical endpoints will include IGA reduction and lesion counts, with PROs collected as secondary endpoints per regulatory expectations.

• Learnings from Asian partner studies inform U.S. trial design, with no anticipated genetic barriers to efficacy translation.

• The acne program benefits from a clear regulatory pathway and established clinical endpoints in the U.S.