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Provided by AGPSecured equity financing with gross proceeds of $175M in April 2026
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
Publications and Presentations
Anticipated Upcoming Milestones
Financial Results for the Three Months Ended March 31, 2026
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
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related timelines and anticipated development milestones, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat, TVB-3567 or any other drug candidates or combination therapies developed by Sagimet; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship with Ascletis, and the success of its development efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Contact:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
Media Contact:
Maggie Whitney
LifeSci Communications
mwhitney@lifescicomms.com
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SAGIMET BIOSCIENCES INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (in thousands, except for share and per share amounts) | |||||||||
| Source for 2023 Data | Three Months Ended March 31, | ||||||||
| 2026 | 2025 | ||||||||
| Operating expenses: | |||||||||
| Research and development | 6,995 | 15,342 | |||||||
| General and administrative | 4,718 | 4,523 | |||||||
| Total operating expenses | 11,713 | 19,865 | |||||||
| Loss from operations | (11,713 | ) | (19,865 | ) | |||||
| Total other income | 1,063 | 1,689 | |||||||
| Net loss | $ | (10,650 | ) | $ | (18,176 | ) | |||
| Net loss per share, basic and diluted | $ | (0.33 | ) | $ | (0.56 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 32,559,704 | 32,195,345 | |||||||
| Net loss | $ | (10,650 | ) | $ | (18,176 | ) | |||
| Other comprehensive loss: | |||||||||
| Net unrealized loss on marketable securities | (112 | ) | (109 | ) | |||||
| Total comprehensive loss | $ | (10,762 | ) | $ | (18,285 | ) | |||
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SAGIMET BIOSCIENCES INC. CONDENSED BALANCE SHEETS (unaudited) (in thousands) | ||||||
| As of | ||||||
| March 31, 2026 | December 31, 2025 | |||||
| Cash, cash equivalents and marketable securities | $ | 104,539 | $ | 113,124 | ||
| Total assets | $ | 107,755 | $ | 116,482 | ||
| Current liabilties | $ | 5,297 | $ | 5,101 | ||
| Stockholders' equity | $ | 102,458 | $ | 111,381 | ||
| Liabilities and stockholders' equity | $ | 107,755 | $ | 116,482 | ||
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