Sagimet Biosciences — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities were $275.8 million as of September 30, 2026; pro forma balance including October financing proceeds was approximately $356 million.
• Research and development expenses were $16.3 million for the three months ended September 30, 2026, compared to $9.7 million in the same period in 2025; for the nine months ended September 30, 2026, expenses were $34.9 million compared to $32.3 million in 2025.
• General and administrative expenses were $5.2 million for the three months ended September 30, 2026, compared to $4.6 million in 2025; for the nine months ended September 30, 2026, expenses were $14.2 million compared to $13.8 million in 2025.
• Net loss was $19.1 million for the three months ended September 30, 2026, compared to $12.9 million in 2025; for the nine months ended September 30, 2026, net loss was $43.8 million compared to $41.5 million in 2025.
• Net loss per share (basic and diluted) was $(0.31) for the three months ended September 30, 2026, compared to $(0.40) in 2025; for the nine months ended September 30, 2026, net loss per share was $(0.88) compared to $(1.28) in 2025.
• Total assets were $282.1 million as of September 30, 2026, compared to $116.5 million as of December 31, 2025.
• Stockholders' equity was $242.2 million as of September 30, 2026, compared to $111.4 million as of December 31, 2025.

Guidance and Future Outlook:

• Pro forma cash and investments balance is expected to fund current operations through mid-2029, including the readout of data from the denifanstat AURORA Phase 3 clinical trial and potential New Drug Application (NDA) submission.
• Topline data from the U.S. AURORA Phase 3 clinical trial for denifanstat is anticipated in the second half of 2027.
• The Phase 2 clinical trial for TVB-3567 in moderate to severe acne is anticipated to initiate before the end of 2026.

Business Segments and Product Lines:

• The AURORA Phase 3 clinical trial for denifanstat in moderate to severe acne began dosing in October 2026, with plans to enroll approximately 800 patients, including 450 adolescents aged 12 to 17.
• Positive Phase 3 clinical trial results for denifanstat from license partner Ascletis in China were presented at EADV 2026 and Fall Clinical Dermatology 2026, showing sustained efficacy across all endpoints through 52 weeks.
• The Phase 1 clinical trial for FASN inhibitor TVB-3567 completed dosing for single- and multiple-ascending dose and food effect parts; Part D evaluating pharmacodynamic biomarkers is ongoing, and Phase 2 doses have been identified.
• Development continues on a topical formulation of a FASN inhibitor for the potential treatment of acne.

Market and Competitive Landscape:

• Denifanstat is being developed as the first oral acne treatment with a novel mechanism of action approved by the FDA in more than 40 years.
• Approximately 10 million Americans live with moderate to severe acne, representing 20% of acne sufferers.
• Acne affects around 85% of persons between the ages of 12 and 24.

Risks and Challenges:

• Forward-looking statements note risks regarding the clinical development and therapeutic potential of denifanstat, TVB-3567, or other drug candidates.
• Risks include the ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines.
• Potential risks involve the accuracy of capital requirement estimates and the ability to maintain and enforce adequate intellectual property protection.
• Risks include the success of development and registration efforts for denifanstat by license partner Ascletis.

Management Commentary and Tone:

• CEO David Happel stated the company is "well positioned to fund our programs through mid-2029" following the October equity financing.
• Management highlighted the initiation of the pivotal U.S. AURORA Phase 3 clinical trial building on positive Phase 3 results from Ascletis.
• The tone indicates confidence in the potential for denifanstat approval to offer a new treatment option for moderate to severe acne.

Other Key Points:

• Completed an underwritten offering of Series A Common Stock and pre-funded warrants in October 2026, generating gross proceeds of $115 million.
• Hosted a virtual Key Opinion Leader (KOL) event on September 30, 2026, featuring Dr. Julie Harper to review 52-week data from Ascletis' Phase 3 open-label extension trial.
• Denifanstat met all primary and secondary endpoints in a 12-week randomized, double-blind Phase 3 clinical trial in China conducted by Ascletis.
• In the open-label extension trial in China, denifanstat showed an Investigator's Global Assessment (IGA) success response rate of 57%, a 72% reduction in total lesions, and a 77% reduction in inflammatory lesions.