Sagimet Widens Loss as Acne Program Advances
Cash and marketable securities reached $257.6 million after an April equity financing.
Sagimet Biosciences (SGMT), a clinical-stage biopharmaceutical company, reported a wider second-quarter net loss as research spending increased and its lead acne program moved closer to Phase 3.
Research and development expense rose 65% sequentially to $11.5 million from $7.0 million and was 59% above the year-earlier period. The increase reversed the first quarter’s 54% year-over-year decline in R&D spending, marking a shift as Sagimet prepared denifanstat for late-stage development.
The quarterly net loss widened to $14.0 million from $10.7 million in the first quarter and $10.4 million a year earlier. The loss narrowed on a per-share basis to $0.26 from $0.32 a year earlier as weighted-average shares outstanding increased 65% to 53.1 million.
General and administrative expense declined to $4.3 million from $4.7 million both sequentially and a year earlier. For the first six months, R&D expense fell 18% to $18.5 million, while the net loss narrowed 14% to $24.6 million, reflecting the lighter research spending recorded in the first quarter.
The U.S. denifanstat acne program advanced from awaiting regulatory clearance in May to operating under an open investigational new drug application in July. Sagimet continues to plan the Phase 3 launch for the second half of 2026. The study is expected to enroll about 800 patients, randomized two-to-one between 50-milligram denifanstat and placebo, with 12-week co-primary efficacy endpoints followed by a 40-week open-label extension.
Total-lesion and inflammatory-lesion counts declined approximately 75% and 80%, respectively, over a 40-week extension. Dry-eye syndrome and dry skin were the only treatment-emergent adverse-event categories reported in at least 5% of patients.
Cash, cash equivalents and marketable securities increased from $104.5 million at March 31 after the company raised $175.0 million in gross proceeds through an April equity financing. The resulting runway is expected to fund operations through 2028 and through the denifanstat Phase 3 acne readout, while a Phase 2 acne trial of TVB-3567 is targeted to begin before year-end 2026.