SGMT

Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. on track to initiate in second half of 2026 First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Secured equity financing with gross proceeds of $175.0 million in April 2026 Cash, cash equivalents and marketable securities of $257.6 million as of June 30, 2026, expected to fund current operations through 2028, including through data readout of denifanstat Phase 3 trial in moderate to severe acne FOSTER CITY, Calif., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), 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 June 30, 2026, and provided corporate updates. “The second quarter saw Sagimet building on our strategic decision to focus on dermatology. Denifanstat, if approved, could offer a convenient oral once-daily treatment option for patients aged 12 years and older living with moderate to severe acne, and would be the first innovative oral treatment approved for acne in more than forty years," said David Happel, Chief Executive Officer of Sagimet. "We plan to advance denifanstat into a registrational Phase 3 clinical trial in moderate to severe acne in the United States in the second half of 2026. With our recent equity financing, we are well positioned to fund our programs through 2028, including through data readout of the Phase 3 denifanstat trial and NDA submission.” Recent Corporate Highlights Strategic focus: In April 2026, Sagimet announced a strategic decision to advance denifanstat in moderate to severe acne for the U.S., prioritizing its dermatology programs in its capital allocation. Equity financing: In April 2026, the Company completed an underwritten equity financing resulting in $175.0 million of gross proceeds, before deducting underwriting discounts and commissions and other offering expenses. Russell Index inclusion: Sagimet was added to the broad-market Russell 3000® Index and small-cap Russell 2000® Index effective June 29, 2026. TVB-3567: A first-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 is ongoing. KOL event: On April 30, 2026, the Company hosted a Key Opinion Leader event with Julie Harper, MD, founding Director and past President of the American Acne and Rosacea Society, discussing the acne treatment landscape and Sagimet's planned Phase 3 clinical trial. A recording of the event is accessible at this link. Publications and Presentations Data showing that Sagimet's FASN inhibitors reduced de novo lipid levels in human sebocytes were presented at the 83rd Society for Investigative Dermatology Annual Meeting in May 2026 (here). In May 2026, Sagimet presented two posters at the European Association for the Study of the Liver (EASL): Anticipated Upcoming Milestones Sagimet intends to advance denifanstat into a registrational Phase 3 clinical trial in moderate to severe acne patients for the U.S. in the second half of 2026. 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 before the end 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 June 30, 2026 Cash, cash equivalents and marketable securities as of June 30, 2026, were $257.6 million. Research and development expense for the three and six months ended June 30, 2026, was $11.5 million and $18.5 million, respectively, compared to $7.2 million and $22.6 million for the three and six months ended June 30, 2025, respectively. General and administrative expense for the three and six months ended June 30, 2026, was $4.3 million and $9.0 million, respectively, compared to $4.7 million and $9.2 million for the three and six months ended June 30, 2025, respectively. Net loss for the three and six months ended June 30, 2026, was $14.0 million and $24.6 million, respectively, compared to $10.4 million and $28.6 million for the three and six months ended June 30, 2025, respectively. 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 and registration 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 [email protected] Media Contact:Maggie WhitneyLifeSci [email protected]

Secured 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 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 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 [email protected] Media Contact: Maggie Whitney LifeSci Communications [email protected]

Completed Phase 1 pharmacokinetic (PK) clinical trial of denifanstat and resmetirom combination Phase 2 trial of denifanstat/resmetirom combination in F4 MASH patients planned to initiate in 2H 2026 Secured global, exclusive license to TAPI’s innovative forms of resmetirom active pharmaceutical ingredients (API) First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Positive topline results in open-label Phase 3 trial evaluating the long-term safety of denifanstat in patients with moderate to severe acne in China reported by Ascletis China’s National Medical Products Administration (NMPA) accepted Ascletis’ New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne SAN MATEO, Calif., March 11, 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 fourth quarter and full year ended December 31, 2025, and provided recent corporate updates. “2025 saw important advances in both our MASH and acne programs,” said David Happel, Chief Executive Officer of Sagimet. “We completed our Phase 1 PK clinical trial of denifanstat and resmetirom combination and anticipate advancing the combination into a proof-of-concept Phase 2 clinical trial in F4 MASH, for which there are currently no approved treatments, in the second half of the year. In acne, positive 52-week data from our license partner Ascletis’ Phase 3 open-label acne trial with denifanstat will support Ascletis’ NDA that was accepted by the Chinese NMPA. We anticipate further exploring the potential role of FASN inhibition in acne in clinical development in 2026.” Recent Corporate Highlights Clinical and Regulatory Updates In December 2025, Sagimet announced the completion of its open-label Phase 1 pharmacokinetic (PK) clinical trial of its oral once-daily fatty acid synthase (FASN) inhibitor, denifanstat, and a thyroid hormone receptor beta (THR-β) agonist, resmetirom, to evaluate pharmacokinetics and potential drug-drug interactions (DDI), and to assess the safety and tolerability of the combination. The combination of denifanstat and resmetirom was generally well-tolerated over the duration of the study, with no safety signals. No serious adverse events occurred, and there were no clinically significant laboratory results, and no treatment discontinuations. Sagimet plans to use these data to advance the development of the combination into a Phase 2 proof-of-concept trial for patients living with MASH with F4 fibrosis. In June 2025, the Company initiated a first-in-human Phase 1 clinical trial of TVB-3567, a FASN inhibitor that is being developed for an acne indication. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TVB-3567 in healthy participants with or without acne. Publications and Presentations In November 2025, Sagimet presented two posters at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2025: In a secondary analysis of the denifanstat Phase 2b FASCINATE-2 clinical trial, denifanstat elicited a significant ≥2-stage improvement in fibrosis in F3 MASH patients, and improved liver fibrosis and several noninvasive biomarkers in a subpopulation of qFibrosis stage 4 MASH patients identified by AI-based digital pathology (here). An analysis utilizing spatial computational histology relying on baseline fibrosis features was used to predict response to denifanstat (here). Corporate Updates In January 2026, Sagimet’s license partner Ascletis Bioscience Co. Ltd. (Ascletis) reported positive topline results in the open-label Phase 3 trial evaluating the long-term safety of ASC40 (denifanstat) tablets in patients with moderate to severe acne in China. This open-label Phase 3 trial enrolled 240 subjects who received oral denifanstat 50 mg once daily for up to 40 weeks. Subjects who were originally randomized to denifanstat in the 12-week ASC40-303 trial had a total of 52 weeks of denifanstat exposure at the end of the long-term safety study. Primary endpoints evaluated safety, and secondary endpoints evaluated certain efficacy measures for up to 52 weeks of denifanstat treatment. Denifanstat was generally well tolerated. Furthermore, subjects treated with denifanstat showed improvements in all of the efficacy endpoints (secondary endpoints of the trial), beyond those observed at 12 weeks. In December 2025, Sagimet announced its entry into a license agreement with Assia Chemical Industries Ltd. (Assia), doing business as TAPI Technology & API Services (TAPI), a subsidiary of Teva Pharmaceutical Industries Ltd. Under the agreement, TAPI granted Sagimet a global, exclusive license to certain intellectual property rights covering innovative forms of TAPI’s resmetirom active pharmaceutical ingredient (API) for Sagimet’s technical evaluation and manufacture, and, if elected by Sagimet, further development of a fixed-dose combination (FDC) product containing denifanstat and resmetirom. Pending patent applications filed by Sagimet and TAPI cover the FDC and the innovative resmetirom forms, respectively. In December 2025, China’s National Medical Products Administration (NMPA) accepted Ascletis’ New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne. Anticipated Upcoming Milestones Following the completion of the Phase 1 PK clinical trial of the combination of denifanstat and resmetirom, Sagimet plans to advance the development of the combination into a Phase 2 proof-of-concept trial for patients living with MASH with F4 fibrosis, expected to initiate in the second half of 2026, subject to consultation with regulatory authorities. Upon completion of the Phase 1 clinical trial of TVB-3567, and subject to consultation with regulatory authorities, Sagimet anticipates starting a Phase 2 clinical trial with TVB-3567 in moderate to severe acne patients in 2026. Financial Results for the Full Year Ended December 31, 2025 Cash, cash equivalents and marketable securities as of December 31, 2025 were $113.1 million. Research and development expense for the three months and year ended December 31, 2025, was $6.7 million and $39.1 million, respectively, compared to $14.2 million and $38.4 million for the three months and year ended December 31, 2024, respectively. General and administrative expense for the three months and year ended December 31, 2025, was $4.0 million and $17.8 million, respectively, compared to $4.0 million and $16.0 million for the three months and year ended December 31, 2024, respectively. Net loss for the three months and year ended December 31, 2025, was $9.6 million and $51.0 million, respectively, compared to $16.2 million and $45.6 million for the three months and year ended December 31, 2024, respectively. 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. Denifanstat, an oral, once-daily pill, met all primary endpoints in its Phase 2b FASCINATE-2 clinical trial in MASH, as well as all primary and secondary endpoints in Sagimet’s license partner for China’s Phase 3 clinical trial in moderate-to-severe acne. A combination of denifanstat and resmetirom was tested in a Phase 1 PK clinical trial and is planned to be developed for patients with MASH cirrhosis (F4). TVB-3567, a second oral FASN inhibitor which is planned to be developed for acne, is currently being tested in a Phase 1 first-in-human clinical trial. For additional information about Sagimet, please visit www.sagimet.com. About MASH MASH is a progressive and severe liver disease which is estimated to impact more than 265 million people worldwide1. MASH is characterized by the build-up of fat in the liver and various degrees of inflammation and fibrosis along with systemic metabolic changes including dyslipidemia (increased fat levels in blood) and insulin resistance. Patients with moderate to severe disease who have advanced fibrosis (F3) or cirrhosis (F4) have the highest risk of liver-related outcomes such as decompensation, hepatocellular carcinoma, and liver transplantation. There are few approved treatments for non-cirrhotic MASH (stages F1, F2 and F3 fibrosis) and no approved treatments for MASH cirrhosis (F4). About Acne Over 50 million people suffer from acne in the U.S., with 5.1 million acne patients treated by dermatologists annually, making it one of the most prevalent skin diseases addressed by physicians.2,3 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. Adherence to topical therapies is lower than with oral agents, with an estimated 30% to 40% of patients not adhering to their topical treatments.4 Patients with acne vulgaris have increased sebum production compared to non-acne populations which contributes to the pathogenesis of the disease. Increased sebum production is due to increased de novo lipogenesis (DNL) locally in the sebocytes. FASN is the last committed step in the DNL pathway which produces the majority (>80%) of key sebum lipids such as palmitate and sapienic acid in acne, and FASN also contributes to inflammatory pathways, making the inhibition of FASN a potentially impactful approach to address acne. 1. Younossi ZM, et al. Hepatology. 2023;77(4): 1335-1347. 2. Bickers DR, et al. J Am Acad Dermatol. 2006;55(3):490-500. 3. American Academy of Dermatology. Burden of Skin Disease. 2017. www.aad.org/BSD. 4. Purvis CG, et al. Ann Pharmacother. 2021;55(10):1297-1299. 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, Sagimet’s cash and financial resources and expected cash runway 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 [email protected] Media Contact: Maggie Whitney LifeSci Communications [email protected]

The combination of denifanstat and resmetirom was generally well-tolerated Pharmacokinetic (PK) results support further development of the combination A Phase 2 trial of a denifanstat/resmetirom combination in F4 MASH patients is planned to initiate in 2H 2026 SAN MATEO, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced positive results in the Phase 1 pharmacokinetic (PK) trial of a combination of its oral once-daily fatty acid synthase (FASN) inhibitor, denifanstat, and a thyroid hormone receptor beta (THR-β) agonist, resmetirom. The Phase 1 PK trial (NCT07216313) of denifanstat and resmetirom was an open-label, 2-cohort study that enrolled 40 healthy adult participants. The objectives were to evaluate multiple-dose and single-dose pharmacokinetics, identify any potential drug-drug interactions (DDIs), and assess the safety and tolerability of the combination. The combination of denifanstat and resmetirom was generally well-tolerated over the duration of the study, with no safety signals. No Serious Adverse Events (SAEs) occurred, and there were no clinically significant laboratory results, and no treatment discontinuations. Sagimet plans to use these data to advance the development of the combination into a Phase 2 proof-of-concept efficacy trial for patients living with metabolic dysfunction-associated steatohepatitis (MASH) with F4 fibrosis, subject to consultation with regulatory authorities. “The successful completion of the Phase 1 PK trial is an important step in our journey to develop a new, potentially synergistic combination treatment for MASH. Patients with cirrhosis of the liver associated with MASH currently have no approved options and our goal is to combine two therapies with complementary mechanisms of action into a single tablet to address this underserved medical need,” said David Happel, Chief Executive Officer of Sagimet. “Our recent presentations at AASLD demonstrated denifanstat’s ability to address advanced fibrosis in MASH patients, including in fibrosis stage qF4 as defined by AI-based digital pathology, and we previously have presented preclinical data demonstrating the synergistic effect of a FASN inhibitor combined with resmetirom on important liver disease markers. With these Phase 1 data in hand, we plan to consult with regulators on the design of a proof-of-concept Phase 2 study, which we plan to initiate in the second half of 2026. Following our recent announcement of a global license agreement with TAPI, a TEVA affiliate, we look forward to drawing on the licensed innovative forms of resmetirom API to develop a convenient, once-daily pill fixed dose combination product to test in Phase 3 for patients living with liver cirrhosis.” Denifanstat, Sagimet's lead product candidate, is an oral, once daily selective FASN inhibitor in development for the treatment of MASH. Its anti-fibrotic mechanism of action coupled with its inhibition of liver fat synthesis and inflammation may be complementary to a fat oxidizer molecule such as resmetirom. Resmetirom is commercially available as Rezdiffra for the treatment of non-cirrhotic MASH with moderate to advanced fibrosis (F2 to F3). Pre-clinical data presented at EASL in 2024 showed in two mouse models of MASH that the combination of a FASN inhibitor (TVB-3664, a mouse surrogate for denifanstat) and resmetirom had a synergistic effect on important markers of liver disease, including improvement of NAS (NAFLD Activity Score) by histologic analysis and more robust improvement in hepatic collagen content compared to the single agents. 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. Denifanstat, an oral, once-daily pill, met all primary endpoints in its Phase 2b FASCINATE-2 clinical trial in MASH as well as all primary and secondary endpoints in Sagimet’s license partner for China’s Phase 3 clinical trial in moderate-to-severe acne. A combination of denifanstat and resmetirom was tested in a Phase 1 PK clinical trial and is planned to be developed for patients with MASH cirrhosis (F4). TVB-3567, a second oral FASN inhibitor which is planned to be developed for acne, is currently being tested in a Phase 1 first-in-human clinical trial. For additional information about Sagimet, please visit www.sagimet.com. About MASH MASH is a progressive and severe liver disease which is estimated to impact more than 265 million people worldwide. MASH is characterized by the build-up of fat in the liver and various degrees of inflammation and fibrosis along with systemic metabolic changes including dyslipidemia (increased fat levels in blood) and insulin resistance. Patients with moderate to severe disease who have advanced fibrosis (F3) or cirrhosis (F4) have the highest risk of liver-related outcomes such as decompensation, hepatocellular carcinoma, and liver transplantation. There are few approved treatments for non-cirrhotic MASH (stages F1, F2 and F3 fibrosis) and no approved treatments for MASH cirrhosis (F4). 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, Sagimet’s cash and financial resources and expected cash runway 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 [email protected] Media Contact: Michael Fitzhugh LifeSci Advisors [email protected]

Phase 1 clinical trial to evaluate the PK of a combination of denifanstat and resmetirom ongoing with data readout expected 1H 2026 First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Ascletis announced completion of its pre-NDA consultation with China’s NMPA and plans to submit an NDA for denifanstat in China for treatment of moderate-to-severe acne vulgaris SAN MATEO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the quarter ended September 30, 2025, and provided recent corporate updates. “This is a dynamic period for Sagimet as we explore the therapeutic potential of FASN inhibition across different indications,” said David Happel, Chief Executive Officer of Sagimet. “As part of our MASH development program targeting cirrhosis of the liver, we have initiated a Phase 1 PK trial evaluating the compatibility of a once-daily combination of denifanstat and resmetirom. We plan to use this data, if positive, to advance the combination to proof-of-concept studies in MASH patients with F4 fibrosis. Additionally, we initiated a Phase 1 clinical trial of our second FASN inhibitor, TVB-3567, for development of an acne indication. We continue to explore how FASN inhibition could benefit patients living with conditions that are currently underserved by approved therapies,” he concluded. Recent Corporate Highlights In September 2025, Sagimet dosed the first participants in a Phase 1 pharmacokinetic (PK) trial of a combination of its oral once-daily fatty acid synthase (FASN) inhibitor, denifanstat, and a thyroid hormone receptor beta (THR-β) agonist, resmetirom. The Phase 1 PK trial of denifanstat and resmetirom is an open-label, 2-cohort study and has enrolled approximately 40 healthy adult participants. The objectives are to evaluate multiple-dose and single-dose pharmacokinetics, identify any potential drug-drug interactions (DDI), and assess the safety and tolerability of the combination. Topline data from this trial are anticipated in the first half of 2026 and, if positive, may be used to advance the development of the combination for patients living with metabolic dysfunction associated steatohepatitis (MASH) into a Phase 2 clinical trial, subject to consultation with regulatory authorities. In October 2025, Ascletis Pharma Inc., the parent company of Sagimet’s license partner for China, Ascletis Bioscience Co. Ltd. (Ascletis), announced that it completed its pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) for denifanstat for the treatment of moderate-to-severe acne vulgaris and plans to submit an NDA soon to the NMPA. Effective November 1, Marie O’Farrell, Ph.D., was promoted to Chief Scientific Officer and Liz Rozek, J.D., was promoted to Chief Legal & Administrative Officer. Publications and Presentations In November 2025, Sagimet presented two posters at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2025: In a secondary analysis of the denifanstat phase 2b FASCINATE-2 clinical trial, denifanstat elicited a significant ≥2-stage improvement in fibrosis in F3 MASH patients, and improved liver fibrosis and several noninvasive biomarkers in a subpopulation of qFibrosis stage 4 MASH patients identified by AI-based digital pathology (here). An analysis utilizing spatial computational histology relying on baseline fibrosis features was used to predict response to denifanstat (here). In October 2025, Sagimet presented the data from Ascletis’ Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris in China at the 2025 Fall Clinical Dermatology Conference (here). As reported by Ascletis, in the clinical trial of 480 patients, once daily 50 mg denifanstat met all efficacy endpoints and was generally well-tolerated. In September 2025, Ascletis presented Phase 3 clinical trial data in acne at the European Academy of Dermatology and Venerology (EADV) 2025 Congress (here). Anticipated Upcoming Milestones Sagimet anticipates the data read out of its Phase 1 clinical trial to evaluate the PK and tolerability of a combination of denifanstat and resmetirom in the first half of 2026. Subject to consultation with regulatory authorities, Sagimet anticipates starting a Phase 2 clinical trial in moderate to severe acne patients in 2026 following its ongoing Phase 1 clinical trial of TVB-3567 for development of an acne indication. Financial Results for the Three and Nine Months Ended September 30, 2025 Cash, cash equivalents and marketable securities as of September 30, 2025 were $125.5 million. Research and development expense for the three and nine months ended September 30, 2025, was $9.7 million and $32.3 million, respectively, compared to $12.7 million and $24.2 million for the three and nine months ended September 30, 2024, respectively. General and administrative expense for the three and nine months ended September 30, 2025 was $4.6 million and $13.8 million, respectively, compared to $4.2 million and $12.0 million for the three and nine months ended September 30, 2024, respectively. Net loss for the three and nine months ended September 30, 2025 was $12.9 million and $41.5 million, respectively, compared to $14.6 million and $29.4 million for the three and nine months ended September 30, 2024, respectively. 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. Denifanstat, an oral, once-daily pill, met all primary endpoints in its Phase 2b FASCINATE-2 clinical trial in MASH as well as all primary and secondary endpoints in Sagimet’s license partner for China’s Phase 3 clinical trial in moderate-to-severe acne. A combination of denifanstat and resmetirom is currently being tested in a Phase 1 PK clinical trial and is planned to be developed for cirrhotic patients living with F4-stage MASH. TVB-3567, a second oral FASN inhibitor which is planned to be developed for acne, is currently being tested in a Phase 1 first-in-human clinical trial. For additional information about Sagimet, please visit www.sagimet.com. About MASH MASH is a progressive and severe liver disease which is estimated to impact more than 265 million people worldwide. MASH is characterized by the build-up of fat in the liver and various degrees of inflammation and fibrosis along with systemic metabolic changes including dyslipidemia (increased fat levels in blood) and insulin resistance. Patients with moderate to severe disease who have advanced fibrosis (F3) or cirrhosis (F4) have the highest risk of liver-related outcomes such as decompensation, hepatocellular carcinoma, and liver transplantation. There are few approved treatments for non-cirrhotic MASH (stages F1, F2 and F3 fibrosis) and no approved treatments for MASH cirrhosis (F4). About Acne There are 5.1 million acne patients treated by dermatologists annually in the U.S., and a total U.S. acne market of over 50 million people.1,2 There is no cure for acne; and due to its pathology, most patients require chronic management and multiple courses of treatment for flare control annually. Additionally, adherence to topical therapies is lower than with oral agents, with an estimated 30% to 40% of patients not adhering to their topical treatments.3 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 anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway 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 [email protected] Media Contact: Michael Fitzhugh LifeSci Advisors [email protected]

About Sagimet Biosciences Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S. For additional information about Sagimet, please visit www.sagimet.com. About Acne There are 5.1 million acne patients treated by dermatologists annually in the U.S., and a total U.S. acne market of over 50 million people.1,2 There is no cure for acne; and due to its pathology, most patients require chronic management and multiple courses of treatment for flare control annually. Additionally, adherence to topical therapies is lower than with oral agents, with an estimated 30% to 40% of patients not adhering to their topical treatments.3 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 anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway 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 Sagimet may develop; 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 [email protected] Media Contact: Michael Fitzhugh LifeSci Advisors [email protected]

Denifanstat met all primary and secondary endpoints in Phase 3 clinical trial in moderate to severe acne conducted by license partner Ascletis in China Initiated first-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 being developed for acne in the U.S. Phase 1 clinical trial to evaluate the pharmacokinetics (PK) of a combination of denifanstat and resmetirom expected to initiate in 2H 2025; data readout expected 1H 2026 SAN MATEO, Calif., Aug. 13, 2025 (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 June 30, 2025, and provided recent corporate updates. “We are making strong progress advancing our differentiated therapeutics, which are in development for the treatment of MASH and acne,” said David Happel, Chief Executive Officer of Sagimet. “Following our license partner Ascletis’ announcement that denifanstat met all primary and secondary endpoints in its Phase 3 clinical trial in moderate to severe acne in China, in June, we initiated a Phase 1 clinical trial of our second FASN inhibitor, TVB-3567, for development of an acne indication. Additionally, pending consultation with regulatory authorities, we plan to initiate a Phase 1 clinical trial to evaluate the PK and tolerability of a combination of our FASN inhibitor denifanstat and resmetirom in the second half of 2025 as the first step towards development of a combination product for patients living with MASH. We continue to believe in the significant therapeutic potential of FASN inhibition across multiple disease states and are pioneering the development of our FASN inhibitors to benefit underserved patients,” he concluded. Recent Corporate Highlights In June, the Company’s license partner Ascletis Bioscience Co. Ltd. (Ascletis) reported that denifanstat met all primary and secondary endpoints and was generally well-tolerated in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris in China. The randomized, double-blind, placebo-controlled, multicenter clinical trial evaluated the safety and efficacy of denifanstat for the treatment of patients with moderate to severe acne in China with 480 enrolled patients randomized 1:1 to receive denifanstat 50mg or placebo, once daily for 12 weeks. Ascletis reported that: All primary endpoints in the Phase 3 trial were met, including: the percentage of treatment success (defined as an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline) (denifanstat 33.2% vs. placebo 14.6%, p<0.0001), the percentage change in total lesion count (denifanstat -57.4% vs. placebo -35.4%, p<0.0001) and the percentage change in inflammatory lesion count (denifanstat -63.5% vs. placebo -43.2%, p<0.0001). The secondary endpoint of change in non-inflammatory lesion count was also met (denifanstat -51.9% vs. placebo -28.9%, p<0.0001). Denifanstat was generally well-tolerated and, following 12 weeks of once-daily oral administration at 50 mg, the incidence rates of treatment-emergent adverse events (TEAE) were comparable between denifanstat and placebo. No incidence rate of TEAEs in any category exceeded 10%. These Phase 3 results underline the potential of FASN inhibition as a novel mechanism of action to address acne, a condition that impacts more than 50 million people in the U.S. annually, and which has seen limited innovation over the past 40 years. In June 2025, the Company initiated a first-in-human Phase 1 clinical trial of TVB-3567 which is being developed for an acne indication in the U.S. The Phase 1 clinical trial is a randomized double-blind placebo-controlled trial designed to evaluate the safety, tolerability, PK and pharmacodynamics of TVB-3567 in healthy participants with or without acne. The trial is comprised of several parts including single ascending dose cohorts and multiple ascending dose cohorts in participants without acne, followed by testing in participants with acne including evaluation of pharmacodynamic biomarkers. The Company held a Key Opinion Leader (KOL) event and webcast on June 16 (link here) featuring Neal Bhatia, MD (Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego). In the webcast, Dr. Bhatia reviewed the results of Ascletis’ Phase 3 trial of denifanstat in moderate to severe acne and discussed the study design of our recently initiated Phase 1 clinical trial of TVB-3567. The Company also hosted a KOL event and webcast on May 29 (link here) featuring Rohit Loomba, MD, MHSc (Professor of Medicine, Chief, Division of Gastroenterology and Hepatology, and Director, MASLD Research Center, University of California San Diego), who discussed the potential for developing a combination of denifanstat, a fat synthesis inhibitor, with a fat oxidizer, such as thyroid hormone beta receptor agonist, resmetirom, to treat advanced metabolic dysfunction-associated steatohepatitis (MASH). The planned development program builds upon the successful results of the Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly in more advanced F3 stage patients, as well as on preclinical data demonstrating the synergistic effect of a FASN inhibitor combined with resmetirom on important liver disease markers. The event also provided an overview of the planned Phase 1 PK clinical trial of the denifanstat and resmetirom combination, and a discussion on the potential benefits of combination therapy to treat patients living with advanced MASH. Publications and Presentations In May 2025, Sagimet presented three poster presentations featuring additional analyses from the Phase 2b FASCINATE-2 trial of denifanstat in MASH at the European Association for the Study of Liver (EASL) Congress 2025. The posters focused on antifibrotic effects of denifanstat in difficult-to-treat patients (link here), new bile acid biomarkers to measure denifanstat response (link here) and alternative endpoints to liver biopsy such as MRI to detect patient improvement (link here). Anticipated Upcoming Milestones Sagimet plans to initiate a Phase 1 clinical trial to evaluate the PK and tolerability of a combination of denifanstat and resmetirom in the second half of 2025, with an anticipated data readout in the first half of 2026. Sagimet initiated a Phase 1 clinical trial of TVB-3567, for development of an acne indication. Contingent on discussions with regulatory authorities and the outcome of the Phase 1 trial, the Company anticipates starting the Phase 2 program in moderate to severe acne patients in 2026. Financial Results for the Three and Six Months Ended June 30, 2025 Cash, cash equivalents and marketable securities as of June 30, 2025 were $135.5 million. Research and development expense for the three and six months ended June 30, 2025, was $7.2 million and $22.6 million, respectively, compared to $6.3 million and $11.6 million for the three and six months ended June 30, 2024, respectively. General and administrative expense for the three and six months ended June 30, 2025 was $4.7 million and $9.2 million, respectively, compared to $4.3 million and $7.8 million for the three and six months ended June 30, 2024, respectively. Net loss for the three and six months ended June 30, 2025 was $10.4 million and $28.6 million, respectively, compared to $8.1 million and $14.7 million for the three and six months ended June 30, 2024, respectively. About Sagimet Biosciences Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S. For additional information about Sagimet, please visit www.sagimet.com. About MASH Metabolic-dysfunction associated steatohepatitis (MASH) is a progressive and severe liver disease which is estimated to impact more than 115 million people worldwide, for which there is only one recently approved treatment in the United States and no currently approved treatments in Europe. In 2023, global liver disease medical societies and patient groups formalized the decision to rename non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to MASH. Additionally, an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. The goal of the name change was to establish an affirmative, non-stigmatizing name and diagnosis. About Acne There are 5.1 million acne patients treated by dermatologists annually in the U.S., and a total U.S. acne market of over 50 million people.1,2 There is no cure for acne; and due to its pathology, most patients require chronic management and multiple courses of treatment for flare control annually. Additionally, adherence to topical therapies is lower than with oral agents, with an estimated 30% to 40% of patients not adhering to their topical treatments.3 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 anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway. 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 Sagimet may develop; 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 [email protected] Media Contact: Michael Fitzhugh LifeSci Advisors [email protected]

Sagimet Biosciences Inc. (NASDAQ:SGMT) said on Wednesday that denifanstat met all primary and secondary endpoints in a Phase 3 trial for moderate to severe acne vulgaris. The trial was conducted by Sagimet’s license partner, Ascletis Bioscience Co. Ltd., in China. Denifanstat is a once-daily oral small-molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for metabolic dysfunction-associated steatohepatitis (MASH) in the rest of the world. Also Read: Nano-Cap Dermata Therapeutics Unveils Positive Data From Once Weekly Drug Study For Acne Additionally, Sagimet recently initiated a Phase 1 first-in-human trial with a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the U.S. The trial randomized 480 patients in China to receive either denifanstat once daily or a placebo for 12 weeks. For the primary endpoint of treatment success, defined as an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline at week 12, the denifanstat group demonstrated a statistically significant 33.2% rate over the placebo group’s 14.6%. Additional goals further corroborated denifanstat’s efficacy versus placebo, including: Reduction in total lesion count (57.4% vs 35.4%). Reduction in inflammatory lesion count (63.5% vs 43.2%). Reduction in non-inflammatory lesion count (51.9% vs. 28.9%). Ascletis reported that denifanstat was generally well-tolerated. Following 12 weeks of once-daily oral administration at 50 mg, treatment-emergent adverse events (TEAE) incidence rates were comparable between denifanstat and placebo. All denifanstat-related adverse events (AEs) were mild or moderate. There were no denifanstat-related grade 3 or 4 AEs and no denifanstat-related serious AEs. No deaths were reported. These Phase 3 results confirm that FASN inhibition represents a potential therapeutic approach within acne. Ascletis has indicated that it plans to submit denifanstat for approval to the China National Medical Products Administration. Building on Ascletis’ Phase 3 results, Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S. In other notable pharmaceutical industry news, GSK plc (NYSE:GSK) agreed to acquire Boston Pharmaceuticals’ lead asset, efimosfermin alfa, a phase 3-ready, investigational specialty medicine for treating and preventing the progression of steatotic liver disease in May. Under the agreement, GSK will pay up to $2 billion in total cash consideration, including $1.2 billion upfront, with the potential for additional success-based milestone payments totaling $800 million. This highlights ongoing investment in the liver disease space, an area where Sagimet is also active with its MASH program. Price Action: SGMT stock is trading higher by 31.7% to $4.78 premarket at last check Wednesday. Read Next: Alto Neuroscience Adds ‘Intriguing’ Depression Asset Via Over $100 Million Deal Image via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article Sagimet's Partner Achieves Positive Results With Oral Acne Drug In Phase 3 Trial In China, Stock Jumps originally appeared on Benzinga.com © 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Denifanstat met all primary and secondary endpoints versus placebo Denifanstat was well tolerated Oral FASN inhibitors offer a novel mechanism of action for the potential treatment of moderate to severe acne Sagimet initiated first-in-human Phase 1 clinical trial of a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the U.S. SAN MATEO, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet’s license partner Ascletis Bioscience Co. Ltd. (Ascletis) in China. Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for MASH in the rest of world. Additionally, Sagimet recently initiated a Phase 1 first-in-human clinical trial with a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the US. “We are highly encouraged by the positive results from Ascletis’ Phase 3 acne trial in China,” said David Happel, Chief Executive Officer of Sagimet. “FASN inhibition represents a novel potential approach to treat moderate to severe acne vulgaris, a widespread condition impacting more than 640 million people worldwide. These positive data support the rationale for our development of our FASN inhibitor TVB-3567 for moderate-to-severe acne and add to the body of evidence of the broad consequences of unchecked overactivity of FASN.” “It is very exciting to see this novel oral acne product candidate progressing through development in light of the limited innovation within the acne space over the past 40 years,” said Dr. Neal Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego and a past Vice President of the American Academy of Dermatology. “These data demonstrate the significant clinical response that a FASN inhibitor can achieve for moderate to severe acne patients by addressing the overproduction of sebum and the inflammatory cascade, two of the primary pathways of acne, and most importantly through a novel mechanism of action. With currently available treatments either showing limited efficacy, high potential for irritation, or risks of antibiotic resistance, control of acne through new modes of action is more critical now than ever.” Over 50 million people suffer from acne in the US, making it one of the most prevalent skin diseases that physicians address annually. Patients with acne vulgaris have increased sebum production compared to non-acne populations which contributes to the pathogenesis of the disease. Increased sebum production is due to increased de novo lipogenesis (DNL) locally in the sebocytes. FASN is the last committed step in the DNL pathway which produces the majority (>80%) of key sebum lipids such as palmitate and sapienic acid in acne, and FASN also contributes to inflammatory pathways. Inhibition of FASN is therefore an attractive therapeutic approach to address acne. In two separate denifanstat Phase 1 clinical trials, Sagimet collected sebum as a non-invasive approach to assess FASN pharmacodynamic activity and showed that use of denifanstat led to significant reductions in sapienic acid, a sebum fatty acid produced only by de novo lipogenesis, confirming FASN inhibition. These results provided mechanistic proof of concept for FASN inhibition in sebum and provided a basis for Ascletis’ successful Phase 2 and 3 clinical trials of denifanstat in acne in China. Clinical Results The Phase 3 clinical trial (NCT06192264) was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat for the treatment of patients with moderate to severe acne. The 480 enrolled patients were randomized 1:1 into two treatment arms to receive denifanstat 50mg or placebo, once daily for 12 weeks. Primary endpoints included the percentage of treatment success (defined as an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline), the percentage change in total lesion count, and the percentage change in inflammatory lesion count. Ascletis reported that denifanstat met all the primary and secondary endpoints. Efficacy results are summarized in Table 1 below. Table 1: Efficacy data from Phase 3 trial of Denifanstat (ASC40) in acne vulgaris Source: Ascletis Press Release issued June 3rd, 2025 Ascletis reported that denifanstat was generally well-tolerated. Following 12 weeks of once-daily oral administration at 50 mg, the incidence rates of treatment-emergent adverse events (TEAE) were comparable between denifanstat and placebo. No incidence rate of TEAEs in any category exceeded 10%. Only two categories of TEAEs had an incidence rate of more than 5% (dry skin and dry eye reported in 6.3% and 5.9 % of denifanstat-treated subjects versus 2.9% and 3.8% in placebo-treated subjects, respectively). All denifanstat-related adverse events (AEs) were mild or moderate. There were no denifanstat-related grade 3 or 4 AEs and no denifanstat-related serious AEs (SAEs). No deaths were reported. These Phase 3 results confirm that FASN inhibition represents a potential therapeutic approach within acne. Ascletis has indicated that it plans to submit denifanstat for approval to the China National Medical Products Administration. Building on Ascletis’ positive Phase 3 results, Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S. About Sagimet Biosciences Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the US. For additional information about Sagimet, please visit www.sagimet.com. About Acne There are 5.1 million acne patients in the U.S. who are treated by dermatologists annually, and a total U.S. acne market of over 50 million people. 1,2 There is no cure for acne; and due to its pathology, most patients require chronic management and multiple courses of treatment for flare control annually. Additionally, adherence to topical therapies is lower than with oral agents, with an estimated 30% to 40% of patients not adhering to their topical treatments. 3 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 anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway. 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 or any other drug candidates Sagimet may develop; 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 [email protected] Media Contact: Michael Fitzhugh LifeSci Advisors [email protected]

Phase 1 clinical trial to evaluate the pharmacokinetics (PK) of a combination of denifanstat and resmetirom expected to initiate in 2H 2025; data readout expected 1H 2026 SAN MATEO, Calif., May 08, 2025 (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, 2025, and provided recent corporate updates. “Sagimet is committed to bringing innovative therapies to MASH patients, following the successful results of our Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly in more advanced F3 stage patients. In a Phase 1 clinical trial in patients with and without hepatic impairment, denifanstat exhibited similar pharmacokinetic characteristics and was well tolerated among all groups. Considering these strong Phase 1 and Phase 2 data, further development of denifanstat in MASH, including as part of a combination program, could potentially offer an opportunity to serve patient groups with the strongest need of treatment including those with stage 4 fibrosis,” said David Happel, Chief Executive Officer of Sagimet. “Building on our presentation of compelling preclinical data at 2024 EASL demonstrating the synergistic effect of a FASN inhibitor combined with resmetirom on important liver disease markers, we anticipate initiating a Phase 1 clinical trial to evaluate the PK and tolerability of a combination of denifanstat and resmetirom in the second half of 2025. If the outcome of this Phase 1 trial is positive, we will explore moving into the development of a combination product -- which we envision as a single tablet -- for patients living with MASH. We remain strongly convinced of the significant therapeutic potential associated with FASN inhibition across multiple disease states.” Recent Corporate Highlights Pre-clinical data presented at EASL in 2024 for two mouse models of MASH showed that the combination of a FASN inhibitor (TVB-3664, a surrogate for denifanstat) and resmetirom had a synergistic effect on important liver disease markers, including improvement of NAS (NAFLD Activity Score) by histologic analysis and more robust improvement in hepatic collagen content compared to the single agents. Synergistic activity of the combination was demonstrated in the rate of histological improvement (NAS ≥2 points). The FASN inhibitor monotherapy showed 33% improvement, resmetirom monotherapy showed 25% improvement, and the combination of the two showed an 80% improvement, a level of improvement that greatly exceeds a simple addition of the activity of the two drugs. Building on this combination data, subject to consultation with regulatory authorities, Sagimet plans to initiate a Phase 1 clinical trial to evaluate the PK of a combination of denifanstat and resmetirom in the second half of 2025, with an anticipated data readout in the first half of 2026. If the outcome of this Phase 1 clinical PK trial is positive, Sagimet anticipates exploring the development of a combination product for MASH patients. Rohit Loomba, M.D., M.H.Sc., Professor of Medicine, Chief, Division of Gastroenterology and Hepatology, and Director, MASLD Research Center, University of California San Diego, said, “I’m excited to see Sagimet initiate development of a combination of denifanstat and resmetirom with this Phase 1 PK trial which will potentially answer important questions about the compatibility of these two molecules in humans. Results of this Phase 1 trial, if successful, could lead to further development of a combination of Sagimet’s fat synthesis inhibitor, denifanstat, with a fat oxidizer in MASH patients, potentially including those with stage 4 fibrosis.” End-of-Phase 2 interactions with the FDA were successfully completed in October 2024, supporting the advancement of denifanstat into Phase 3 in MASH. While Sagimet is operationally ready to dose patients in Phase 3 trials in F2/F3 MASH patients, it does not intend to initiate these trials until such time as it has sufficient funding to do so. Sagimet is currently exploring various alternatives to fund the ongoing development of denifanstat as a monotherapy. Effective May 6, 2025, George Kemble, Ph.D. transitioned from his executive officer position as Executive Chairman and moved into the role of non-executive Chair of the Board. Also effective as of May 6, 2025, the Board appointed Beth Seidenberg, M.D. to serve as Lead Independent Director of the Board. Effective as of June 9, 2025, the date of Sagimet’s Annual Meeting, Merdad Parsey, M.D., Ph.D, will step off the Board. The Board thanks Dr. Parsey for his fifteen years of service to the Company as a Director. Publications and Presentations In May 2025, Sagimet is presenting three poster presentations featuring additional analyses from the Phase 2b FASCINATE-2 trial of denifanstat in MASH at the European Association for the Study of Liver (EASL) Congress 2025. The posters focus on antifibrotic effects of denifanstat in difficult-to-treat patients, new bile acid biomarkers to measure denifanstat response and alternative endpoints to liver biopsy such as MRI to detect patient improvement. In February 2025, Sagimet delivered an oral presentation at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium. The presentation featured lipidomic data on improvements in polyunsaturated fatty acid triglycerides and LDL cholesterol levels in advanced fibrosis patients from the Phase 2b FASCINATE-2 trial of denifanstat in MASH, and preclinical data showing reduction of LDL and chemokines in a preclinical atherosclerosis model with a FASN inhibitor (TVB-3664, a surrogate for denifanstat). In January 2025, Sagimet delivered an oral presentation at the 9th Annual MASH-TAG Conference highlighting the differentiated mechanism of action of the FASN inhibitor denifanstat and its observed anti-fibrotic effect in the Phase 2b FASCINATE-2 trial in F2/F3 MASH. Anticipated Upcoming Milestones Phase 1 clinical trial to evaluate the PK and tolerability of a combination of denifanstat and resmetirom, planned to initiate in the second half of 2025, with an anticipated data readout in the first half of 2026. In November 2024, the Company’s license partner for China, Ascletis BioScience Co. Ltd. (Ascletis) announced completion of enrollment of 480 patients in its Phase 3 clinical trial of denifanstat for acne in China, and that it expects to announce topline results in the second quarter of 2025. First-in-human Phase 1 clinical trial of TVB-3567 in acne expected to initiate in the second half of 2025, following the IND clearance in March 2025. Financial Results for the Three Months Ended March 31, 2025 Cash, cash equivalents and marketable securities as of March 31, 2025, were $144.6 million. Research and development expense for the quarter ended March 31, 2025, was $15.3 million compared to $5.3 million for the first quarter of 2024. General and administrative expense for the quarter ended March 31, 2025, was $4.5 million, compared to $3.5 million for the first quarter of 2024. Net loss for the quarter ended March 31, 2025, was $18.2 million compared to $6.6 million for the first quarter of 2024. About Sagimet Biosciences Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet’s second FASN inhibitor, TVB-3567, a potent and selective small molecule FASN inhibitor, received IND clearance in March 2025, allowing initiation of a first-in-human Phase 1 clinical trial in acne. For additional information about Sagimet, please visit www.sagimet.com. About MASH Metabolic-dysfunction associated steatohepatitis (MASH) is a progressive and severe liver disease which is estimated to impact more than 115 million people worldwide, for which there is only one recently approved treatment in the United States and no currently approved treatments in Europe. In 2023, global liver disease medical societies and patient groups formalized the decision to rename non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to MASH. Additionally, an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. The goal of the name change was to establish an affirmative, non-stigmatizing name and diagnosis. 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 anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway. 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 or any other drug candidates Sagimet may develop; 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 [email protected] Media Contact: Michael Fitzhugh LifeSci Advisors [email protected]