Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. planned to initiate in second half of 2026
First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing
Cumulative cash, cash equivalents and marketable securities expected to fund current operations through 2028, including through data readout of denifanstat Phase 3 trial in moderate to severe acne
SAN MATEO, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (NASDAQ:SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the quarter ended March 31, 2026, and provided corporate updates.
"Our recent strategic decision to focus on dermatology marks a turning point for Sagimet, and we are excited about the path ahead. In the near term, we are targeting the second half of 2026 to initiate a Phase 3 clinical trial of denifanstat in moderate to severe acne in the U.S. We believe that denifanstat, with its differentiated mode of action, could potentially offer a convenient oral once-daily treatment option for those living with moderate to severe acne. The clinical community caring for patients with acne has waited more than 40 years for an innovative oral treatment," said David Happel, Chief Executive Officer of Sagimet. "We recently strengthened Sagimet's ability to move forward with its innovative dermatology programs with the completion of a $175 million equity financing. Combined with our existing cash balance, we are well capitalized to fund our programs through 2028 including data readout of our planned denifanstat Phase 3 clinical trial in moderate to severe acne."
Recent Corporate Highlights
The Company recently completed an underwritten offering of 29,166,700 shares of its Series A common stock at a price of $6.00 per share, resulting in $175.0 million gross proceeds, before deducting underwriting discounts and commissions and other offering expenses.
The financing included participation from new and existing investors, including Balyasny Asset Management, Blue Owl Healthcare Opportunities, BVF Partners L.P., Caligan Partners, Coastlands Capital, Farallon Capital Management, Great Point Partners, LLC, Woodline Partners LP and a large mutual fund.
The Company currently expects that its existing cash and cash equivalents, together with the proceeds from the offering, will fund its acne programs through 2028 and the data readout of the Company's planned denifanstat Phase 3 clinical trial in moderate to severe acne.
A first-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 is ongoing.
The Company held a key opinion leader (KOL) event and webcast on April 30 (link here) featuring Julie Harper, MD (Founding Director and past President of the American Acne and Rosacea Society). In the webcast, Dr. Harper discussed the current acne treatment landscape and the unmet need for additional treatment options for moderate to severe acne. Management also discussed the planned Phase 3 clinical trial of denifanstat in moderate to severe acne for the U.S., expected to begin in the second half of 2026.
Publications and Presentations
Data showing that Sagimet's FASN inhibitors reduced de novo lipid levels (DNL) in human sebocytes will be discussed in a poster presentation at the 83rd Society for Investigative Dermatology Annual Meeting in Chicago on May 15, 2026.
Anticipated Upcoming Milestones
Sagimet plans to initiate a Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. in the second half of 2026, subject to Investigational New Drug (IND) clearance.
Upon completion of the Phase 1 clinical trial of TVB-3567, subject to consultation with regulatory authorities, Sagimet plans to initiate a Phase 2 clinical trial with TVB-3567 in moderate to severe acne patients in the second half of 2026.
The Company also plans to develop a topical formulation of a FASN inhibitor for the potential treatment of acne.
Financial Results for the Three Months Ended March 31, 2026
Cash, cash equivalents and marketable securities as of March 31, 2026, were $104.5 million.
Research and development expense for the quarter ended March 31, 2026, was $7.0 million compared to $15.3 million for the first quarter of 2025.
General and administrative expense for the quarter ended March 31, 2026, was $4.7 million, compared to $4.5 million for the first quarter of 2025.
Net loss for the quarter ended March 31, 2026, was $10.7 million compared to $18.2 million for the first quarter of 2025.
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic pathways in conditions resulting from the overproduction of the fatty acid, palmitate. FASN is a regulator of lipid synthesis, and a key pathway implicated in multiple diseases, such as acne, MASH and certain FASN-dependent tumor types. For additional information about Sagimet, please visit www.sagimet.com.
About Acne
Acne is one of the most common skin conditions in the U.S., with approximately 50 million Americans affected annually and more than 5 million seeking medical treatment for acne each year. Acne affects around 85% of persons between the ages of 12 and 24. Moderate to severe acne accounts for 20% of acne sufferers, or approximately 10 million people in the U.S. annually. There is no cure for acne; and due to its pathology, most patients require chronic management and multiple annual courses of treatment for flare control.
Forward-Looking Statements
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