Sagimet Biosciences (SGMT 0.21%), a clinical-stage biotechnology developer focused on fatty acid synthase (FASN) inhibitors, delivered its second-quarter results on August 13, 2025. The most important news was the successful Phase 3 acne results from partner Ascletis in China, highlighting meaningful progress for its lead drug denifanstat. The company reported a net loss per share of $0.32, which was better than the consensus estimate of a $0.51 per share loss. Sagimet remains pre-revenue, so no revenue was recorded as expected. Overall, the quarter brought notable clinical successes and continued pipeline investment, but operating losses and elevated cash burn persisted.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.32) | $(0.51) | $(0.25) | (28.0%) |
| Revenue (GAAP) | $0.0 | $0.0 | $0.0 | 0% |
| Research & Development Expense | $7.2 million | $6.3 million | 14.3% | |
| General & Administrative Expense | $4.7 million | $4.3 million | N/A | |
| Net Loss | $10.4 million | $8.1 million | 28.4% |
Source: Analyst estimates for the quarter provided by FactSet.
Company Overview and Current Focus
Sagimet Biosciences is a U.S.-based biotechnology company developing a new class of small molecule drugs, specifically targeting fatty acid synthase (FASN). This enzyme is involved in lipid metabolism, which is linked to conditions like metabolic dysfunction-associated steatohepatitis (MASH—formerly non-alcoholic steatohepatitis), acne, and potentially some cancers. Its lead asset is denifanstat, which has advanced through mid- and late-stage clinical testing in multiple disease areas.
The company's current focus includes demonstrating denifanstat’s efficacy in large, high-need diseases like MASH and acne, using data from ongoing clinical trials. It is also expanding its FASN inhibitor pipeline with new drug candidates such as TVB-3567. Key success factors are regulatory milestones, strong safety and efficacy data, and building international partnerships to expand market reach.
Quarter in Review: Clinical, Financial, and Operational Highlights
This quarter marked a pivotal clinical achievement for Sagimet with denifanstat—its lead FASN inhibitor for acne and MASH. The most prominent news emerged from its licensing partner Ascletis in China. Denifanstat met all primary and secondary endpoints in a 480-patient Phase 3 acne trial. Patients receiving denifanstat achieved a 33.2% "treatment success" rate by IGA assessment, compared to 14.6% for placebo (p<0.0001). Significant reductions were also seen in total lesion count (down 57.4% with denifanstat vs. 35.4% with placebo). and in both inflammatory and non-inflammatory lesions, all with strong statistical significance. Importantly, Incidence rates of treatment-emergent adverse events were comparable between denifanstat and placebo, with no adverse event type exceeding a 10% incidence rate.
The company also made strategic moves in broadening its drug pipeline. In June, it began a first-in-human Phase 1 trial for TVB-3567, another FASN inhibitor targeting moderate to severe acne. A new combination study with denifanstat and resmetirom (a thyroid hormone receptor-β agonist used for metabolic liver diseases) is set to launch in the second half of 2025 (calendar year), with an anticipated data readout in the first half of 2026.
In the MASH program, Sagimet continued to highlight denifanstat’s promise, especially after positive Phase 2b data presented at the European Association for the Study of the Liver in 2025. These data contributed to the FDA granting Breakthrough Therapy designation—a status that can speed up regulatory review. Post-quarter, the company remains operationally ready for Phase 3 MASH trial enrollment but is holding off until sufficient funding is in place. This is a reminder of the complexities and financing needs typical in innovative biotechnology pipelines.
On the financial side, operating expenses rose across research, development, and administrative functions. Research and development expense (GAAP) rose 14.3% to $7.2 million compared to Q2 2024, and General and administrative expense (GAAP) increased 9.3% to $4.7 million compared to Q2 2024. The net loss (GAAP) was $10.4 million, up from $8.1 million in Q2 2024. These cost increases reflect expansion across its clinical programs and pipeline. The cash, cash equivalents, and marketable securities balance stood at $135.5 million as of June 30, 2025, down from $158.7 million as of December 31, 2024.
There were also a few notable operational updates. The company saw changes in board leadership, including the transition of former executive chairman George Kemble, Ph.D, to the non-executive chair role, and the appointment of Beth Seidenberg, M.D, as lead independent director.
Looking Ahead: Management Outlook and Investor Considerations
Sagimet did not provide formal financial guidance for the rest of fiscal 2025. This is typical for clinical-stage, pre-revenue companies focused on research and clinical trial milestones. Management did, however, highlight several upcoming milestones: initiating a Phase 1 study of a denifanstat/resmetirom combination and advancing TVB-3567 toward Phase 2 in acne, pending results from the current study. No revenue projections or commercialization timelines were shared.
In the months ahead, investors should track the pace of cash consumption, outcomes from the combination trials, and developments in funding or partnership activity that might enable the next stage of Phase 3 trials for denifanstat in MASH. Pipeline achievements, clinical milestones, and additional license agreements, especially internationally, may represent significant events for Sagimet’s future progress. SGMT does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
