{"success":true,"data":{"pressRelease":{"id":"156335","rtpr_id":"nGNXbgvjGP-20260930","ticker":"SGMT","exchange":"NASDAQ","all_tickers":["SGMT"],"title":"Sagimet Announces Positive Full 52-Week Results from License Partner Ascletis' Phase 3 Open-Label Extension Clinical Trial of Denifanstat in Acne Presented at EADV 2026","author":"Globe Newswire","published_at":"2026-09-30T10:00:00.328Z","article_body":"* In the Phase 3 open-label extension clinical trial (OLE), patients with\nmoderate to severe acne received denifanstat for up to 52 weeks, including\nprior placebo patients\n* Denifanstat showed progressive and sustained improvements across all\nefficacy endpoints in the OLE, including Investigator's Global Assessment\n(IGA) success with a response rate of 57%, 72% reduction in total lesions, and\n77% reduction in inflammatory lesions, and was generally well-tolerated, with\nno adverse event-related permanent discontinuations\n* Patient screening for AURORA U.S. Phase 3 clinical trial expected to begin\nin October 2026\n* Sagimet to host a KOL event and webcast September 30, 2026 at 1 PM ET\nFOSTER CITY, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences\nInc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing\nnovel therapeutics targeting dysfunctional metabolic and fibrotic pathways,\ntoday announced positive 52-week results from the Phase 3 ASC40-304 OLE\nclinical trial of denifanstat in patients with moderate to severe acne\nvulgaris, conducted by license partner Ascletis BioScience Co. Ltd. (Ascletis)\nin China. The results were presented at the European Academy of Dermatology\nand Venereology Congress (EADV) in Vienna by Ascletis. Denifanstat is a\nonce-daily oral small molecule fatty acid synthase (FASN) inhibitor being\ndeveloped by Ascletis as ASC40 in China where it holds an exclusive license\nto denifanstat, and by Sagimet in the rest of the world.\n\nThe Phase 3 OLE clinical trial, ASC40-304, evaluated the long-term safety of\ndenifanstat in patients with moderate to severe acne vulgaris who were\npreviously enrolled in the 12-week randomized, double-blind,\nplacebo-controlled Phase 3 ASC40-303 clinical trial, conducted in China by\nAscletis. 240 patients rolled over into the OLE trial, for a total trial\nduration of up to 52 weeks. 116 of those patients had received denifanstat,\nand 124 patients had received placebo in the original 12-week double-blind\nASC40-303 trial. Primary endpoints evaluated safety, and secondary endpoints\nevaluated efficacy, including reduction in IGA from baseline and reduction in\ntotal lesion count and inflammatory lesion count from baseline.\n\nPhase 3 Open-Label Extension Results\n\nThe baseline characteristics of the OLE cohorts were consistent with the\noverall study population, as shown below:\n\nBaseline Characteristics of ASC40-304 OLE Cohorts at ASC40-303 Baseline\n\n Baseline Characteristics                  ASC40-304 Denifanstat/Denifanstat (n=116)  ASC40-304 Placebo/Denifanstat (n=124)  ASC40-303 Total   \n                                                                                                                             (n=480)           \n Age, years, mean (SD)                     22.5 (4.1)                                 22.3 (3.3)                             22.6 (3.8)        \n Male, n (%)                               31 (26.7)                                  47 (37.9)                              150 (31.3)        \n Female, n (%)                             85 (73.3)                                  77 (62.1)                              330 (68.8)        \n IGA=3 (moderate), n (%)                   101 (87.1)                                 106 (85.5)                             412 (85.8)        \n IGA=4 (severe), n (%)                     15 (12.9)                                  18 (14.5)                              68 (14.2)         \n Total lesion count, mean (SD)             102.8 (25.3)                               103.2 (24.4)                           102.1 (24.8)      \n Inflammatory lesion count, mean (SD)      42.0 (12.2)                                43.5 (11.8)                            42.6 (11.9)       \n Non-Inflammatory lesion count, mean (SD)  60.8 (19.3)                                59.7 (20.9)                            59.5 (19.9)       \n\nTreatment success was defined as at least a 2-point reduction from baseline in\nInvestigator's Global Assessment (IGA) score with a score of 0 (clear) or 1\n(almost clear). At the end of the trial, treatment success rates and mean\npercentage changes, compared to the ASC40-303 baseline, were:\n\n Efficacy Endpoints                              Denifanstat 12wk /   Placebo 12wk /      Total (n=240)  \n                                                 Denifanstat 40wk     Denifanstat 40wk                   \n                                                 (n=116)              (n=124)                            \n Treatment success rate                          57.8%                55.6%               56.7%          \n Mean % change in total lesion count             -73.0%               -70.7%              -71.8%         \n Mean % change in inflammatory lesion count      -78.1%               -75.8%              -76.9%         \n Mean % change in non-inflammatory lesion count  -68.3%               -65.5%              -66.9%         \n\nNote: Total skin lesion counts and inflammatory skin lesion counts reduced by\napproximately 75% and 80%, respectively, compared to ASC40-303 baseline for\npatients who completed the OLE trial.\n\nDenifanstat was generally well-tolerated in the OLE with patients receiving up\nto 52 weeks of exposure, with no permanent discontinuations of study drug due\nto adverse events and no drug-related serious adverse events among patients\ntreated with denifanstat. Only two categories of treatment-related adverse\nevents had an incidence of more than 5% over the 52-week period: dry skin in\n7.1% and dry eye in 5.9%.\n\n\"The positive results presented today at EADV reinforce our confidence in\ndenifanstat as we prepare to begin patient screening for our U.S. AURORA Phase\n3 clinical trial in October, with first patient enrollment expected shortly\nthereafter,\" said David Happel, Chief Executive Officer of Sagimet. \"Annually\napproximately ten million people in the U.S. live with moderate to severe\nacne. Denifanstat, if approved, could offer a convenient, once-daily oral\nmedication for this underserved patient population, and would be the first\noral treatment with a novel mechanism of action approved for acne in more than\nforty years.\"\n\n\"The open-label extension trial provides important data to support our AURORA\nPhase 3 program,\" said Andreas Grauer, MD, Chief Medical Officer of Sagimet.\n\"It is particularly encouraging that patients continued to improve with longer\ntreatment, and denifanstat remained generally well-tolerated through the\nopen-label extension trial, with exposure to denifanstat up to 52 weeks.\nNotably, patients who crossed over from placebo achieved treatment success\nrates similar to those treated with denifanstat from the start. Together,\nthese results provide meaningful long-term experience with the 50 mg\ndenifanstat dose we are taking forward in AURORA.\"\n\nVirtual Key Opinion Leader Conference Call Information\n\nSagimet Biosciences will host a virtual KOL event with Julie Harper, MD,\nFounding Director and past President of the American Acne and Rosacea Society\non September 30, 2026 at 1 PM ET.\n\nDr. Harper will join company management for a review of the 52-week data from\nlicense partner Ascletis’ Phase 3 open-label extension clinical trial of\ndenifanstat in moderate to severe acne vulgaris in China and an update on the\ncompany’s planned U.S. Phase 3 AURORA clinical trial of denifanstat for the\ntreatment of moderate to severe acne. Live webcast available: LINK\n(https://www.globenewswire.com/Tracker?data=Fg3el_MEq-_rMIP9-kvBdMov2VH23QCXqHiw41CaNCR2fgk3e4mLlMjcmA47sSbQpBtjFzJ0nsjMLzetboz-Viid8grEG6tCPaGlqvP7Y7IOeQeWR-rxVMR74XgueN-_U0SGsaaUdsTLzjRGTxxJYKQrEU6d1aB9ImryauigEfw1yecrefH8I29G9IZPt8H8zAjiXOHc5FgNgNKRDOB89qa79k3G18r_pThC9sRyG2Kg-9-fCAGR-Ig4WZvGTkiStLRfBFIduBvRMUHO6_XI0sdSZpNKmW1ztHiL63wbUTlQt4VyKHbNvrT_lpwdtyipxWNtGl3s9zZiGjK5T68xiJ-n9kcs37sPxWx57fOBn5nBbLRiLzy3_7CU44Z4_83cxzQooS8NcazHVciniaXvNTRzRlkkxmIMzcpVCDnvGaQoHrlZ5g2aOCLPo2BRVIok)\n\nAbout the Ascletis Phase 3 Clinical Trial and Open-Label Extension\n\nASC40-303 (NCT06192264) was a randomized, double-blind, placebo-controlled\n12-week Phase 3 clinical trial of denifanstat in 480 patients with moderate to\nsevere acne vulgaris, conducted in China by Ascletis. Patients were randomized\n1:1 to denifanstat 50 mg or placebo once daily. Denifanstat met all primary\nand secondary endpoints and was generally well-tolerated.\n\nASC40-304 (NCT06248008) was a multi-center, open-label Phase 3 extension\nevaluating the long-term safety of denifanstat in patients with moderate to\nsevere acne vulgaris who were previously enrolled in the double-blind,\nrandomized, placebo-controlled 12-week Phase 3 ASC40-303 trial. This\nopen-label Phase 3 trial enrolled 240 subjects that received oral denifanstat\n50 mg once daily for up to 40 weeks. Subjects who were originally randomized\nto denifanstat in ASC40-303 trial had a total of up to 52 weeks of denifanstat\nexposure. Primary endpoints evaluated safety, and secondary endpoints\nevaluated efficacy, including reduction in IGA from baseline and reduction in\ntotal lesion count and inflammatory lesion count from baseline for up to 52\nweeks of denifanstat treatment. Denifanstat was generally well-tolerated.\nSubjects treated with denifanstat showed improvements in all efficacy\nendpoints (secondary endpoints of the trial) beyond those observed at 12\nweeks. \n\nAbout the AURORA Phase 3 Clinical Trial\n\nThe AURORA multi-center, randomized, double-blind, placebo-controlled Phase 3\nclinical trial of denifanstat in moderate to severe acne is intended to enroll\napproximately 800 U.S. patients aged 12 years and older, of which 450 are\nexpected to be adolescents aged 12 to 17 years. Patients will be randomized\n2:1 to receive denifanstat 50 mg or placebo once daily for 12 weeks. The trial\nwill have three co-primary endpoints that will be assessed at week 12: the\nproportion of patients achieving treatment success in a global assessment\nscore, defined as at least a 2-point reduction from baseline with a score of 0\n(clear) or 1 (almost clear); absolute change in inflammatory skin lesion\ncounts from baseline; and absolute change in non-inflammatory skin lesion\ncounts from baseline. A subset of approximately 530 patients completing the\ndouble-blind period will be eligible to enter a 40-week open-label extension\nevaluating the long-term safety of denifanstat.\n\nAbout Denifanstat\n\nDenifanstat is an oral, once-daily FASN inhibitor in development for the\ntreatment of moderate to severe acne. In trials conducted by Sagimet’s\nlicense partner, Ascletis BioScience Co. Ltd. (Ascletis) in China,\ndenifanstat met all primary and secondary endpoints in a 12 week randomized,\ndouble-blind Phase 3 clinical trial in moderate to severe acne vulgaris and\nwas generally well-tolerated and showed improvements in all efficacy endpoints\nmeasured at 52 weeks (secondary endpoints of the trial) in an open-label\nextension clinical trial evaluating denifanstat’s long-term safety in\npatients with moderate to severe acne. Denifanstat is being developed\nby Ascletis as ASC40 for acne in China and by Sagimet in the rest of\nworld.\n\nAbout Acne\n\nAcne is one of the most common skin conditions in the U.S., with\napproximately 50 million Americans affected annually and more than 5 million\nseeking medical treatment for acne each year. Acne affects around 85% of\npersons between the ages of 12 and 24. Moderate to severe acne accounts for\n20% of acne sufferers, or approximately 10 million people in\nthe U.S. annually. There is no cure for acne, and due to its pathology, most\npatients require chronic management and multiple annual courses of treatment\nfor flare control.\n\nAbout Sagimet Biosciences\n\nSagimet is a clinical-stage biopharmaceutical company developing novel FASN\ninhibitors designed to target dysfunctional metabolic and fibrotic pathways in\nconditions resulting from the overproduction of the fatty acid, palmitate.\nFASN is a regulator of lipid synthesis, a key pathway implicated in multiple\ndiseases, such as acne, MASH and certain FASN-dependent tumor types. For\nadditional information about Sagimet, please visit www.sagimet.com.\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of,\nand made pursuant to the safe harbor provisions of, The Private Securities\nLitigation Reform Act of 1995. All statements contained in this press release,\nother than statements of historical facts or statements that relate to present\nfacts or current conditions, including but not limited to, statements\nregarding the expected timing of the presentation of data from ongoing\nclinical trials, Sagimet’s clinical development plans and related timelines\nand anticipated development milestones, are forward-looking statements. These\nstatements involve known and unknown risks, uncertainties and other important\nfactors that may cause Sagimet’s actual results, performance or achievements\nto be materially different from any future results, performance or\nachievements expressed or implied by the forward-looking statements. In some\ncases, these statements can be identified by terms such as “may,”\n“might,” “will,” “should,” “expect,” “plan,” “aim,”\n“seek,” “anticipate,” “could,” “intend,” “target,”\n“project,” “contemplate,” “believe,” “estimate,”\n“predict,” “forecast,” “potential” or “continue” or the\nnegative of these terms or other similar expressions. The forward-looking\nstatements in this press release are only predictions. Sagimet has based these\nforward-looking statements largely on its current expectations and projections\nabout future events and financial trends that Sagimet believes may affect its\nbusiness, financial condition and results of operations. These forward-looking\nstatements speak only as of the date of this press release and are subject to\na number of risks, uncertainties and assumptions, some of which cannot be\npredicted or quantified and some of which are beyond Sagimet’s control,\nincluding, among others: the clinical development and therapeutic potential of\ndenifanstat, TVB-3567 or any other drug candidates or combination therapies\ndeveloped by Sagimet; Sagimet’s ability to advance drug candidates into and\nsuccessfully complete clinical trials within anticipated timelines;\nSagimet’s relationship with Ascletis, and the success of its development and\nregistration efforts for denifanstat; the accuracy of Sagimet’s estimates\nregarding its capital requirements and Sagimet’s ability to maintain and\nsuccessfully enforce adequate intellectual property protection. These and\nother risks and uncertainties are described more fully in the “Risk\nFactors” section of Sagimet’s most recent filings with the Securities and\nExchange Commission and available at www.sec.gov. You should not rely on these\nforward-looking statements as predictions of future events. The events and\ncircumstances reflected in these forward-looking statements may not be\nachieved or occur, and actual results could differ materially from those\nprojected in the forward-looking statements. Moreover, Sagimet operates in a\ndynamic industry and economy. New risk factors and uncertainties may emerge\nfrom time to time, and it is not possible for management to predict all risk\nfactors and uncertainties that Sagimet may face. Except as required by\napplicable law, Sagimet does not plan to publicly update or revise any\nforward-looking statements contained herein, whether as a result of any new\ninformation, future events, changed circumstances or otherwise.\n\nInvestor Contact:\nJoyce Allaire \nLifeSci Advisors \nJAllaire@LifeSciAdvisors.com\n\nMedia Contact:\nMaggie Whitney\nLifeSci Communications\nmwhitney@lifescicomms.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e944daed-3f71-402b-bb23-82149e5c0d26)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXbgvjGP-20260930","title":"Sagimet Announces Positive Full 52-Week Results from License Partner Ascletis' Phase 3 Open-Label Extension Clinical Trial of Denifanstat in Acne Presented at EADV 2026","author":"Globe Newswire","ticker":"SGMT","created":"2026-09-30T10:00:00.328Z","tickers":["SGMT"],"exchange":"NASDAQ","article_body":"* In the Phase 3 open-label extension clinical trial (OLE), patients with\nmoderate to severe acne received denifanstat for up to 52 weeks, including\nprior placebo patients\n* Denifanstat showed progressive and sustained improvements across all\nefficacy endpoints in the OLE, including Investigator's Global Assessment\n(IGA) success with a response rate of 57%, 72% reduction in total lesions, and\n77% reduction in inflammatory lesions, and was generally well-tolerated, with\nno adverse event-related permanent discontinuations\n* Patient screening for AURORA U.S. Phase 3 clinical trial expected to begin\nin October 2026\n* Sagimet to host a KOL event and webcast September 30, 2026 at 1 PM ET\nFOSTER CITY, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences\nInc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing\nnovel therapeutics targeting dysfunctional metabolic and fibrotic pathways,\ntoday announced positive 52-week results from the Phase 3 ASC40-304 OLE\nclinical trial of denifanstat in patients with moderate to severe acne\nvulgaris, conducted by license partner Ascletis BioScience Co. Ltd. (Ascletis)\nin China. The results were presented at the European Academy of Dermatology\nand Venereology Congress (EADV) in Vienna by Ascletis. Denifanstat is a\nonce-daily oral small molecule fatty acid synthase (FASN) inhibitor being\ndeveloped by Ascletis as ASC40 in China where it holds an exclusive license\nto denifanstat, and by Sagimet in the rest of the world.\n\nThe Phase 3 OLE clinical trial, ASC40-304, evaluated the long-term safety of\ndenifanstat in patients with moderate to severe acne vulgaris who were\npreviously enrolled in the 12-week randomized, double-blind,\nplacebo-controlled Phase 3 ASC40-303 clinical trial, conducted in China by\nAscletis. 240 patients rolled over into the OLE trial, for a total trial\nduration of up to 52 weeks. 116 of those patients had received denifanstat,\nand 124 patients had received placebo in the original 12-week double-blind\nASC40-303 trial. Primary endpoints evaluated safety, and secondary endpoints\nevaluated efficacy, including reduction in IGA from baseline and reduction in\ntotal lesion count and inflammatory lesion count from baseline.\n\nPhase 3 Open-Label Extension Results\n\nThe baseline characteristics of the OLE cohorts were consistent with the\noverall study population, as shown below:\n\nBaseline Characteristics of ASC40-304 OLE Cohorts at ASC40-303 Baseline\n\n Baseline Characteristics                  ASC40-304 Denifanstat/Denifanstat (n=116)  ASC40-304 Placebo/Denifanstat (n=124)  ASC40-303 Total   \n                                                                                                                             (n=480)           \n Age, years, mean (SD)                     22.5 (4.1)                                 22.3 (3.3)                             22.6 (3.8)        \n Male, n (%)                               31 (26.7)                                  47 (37.9)                              150 (31.3)        \n Female, n (%)                             85 (73.3)                                  77 (62.1)                              330 (68.8)        \n IGA=3 (moderate), n (%)                   101 (87.1)                                 106 (85.5)                             412 (85.8)        \n IGA=4 (severe), n (%)                     15 (12.9)                                  18 (14.5)                              68 (14.2)         \n Total lesion count, mean (SD)             102.8 (25.3)                               103.2 (24.4)                           102.1 (24.8)      \n Inflammatory lesion count, mean (SD)      42.0 (12.2)                                43.5 (11.8)                            42.6 (11.9)       \n Non-Inflammatory lesion count, mean (SD)  60.8 (19.3)                                59.7 (20.9)                            59.5 (19.9)       \n\nTreatment success was defined as at least a 2-point reduction from baseline in\nInvestigator's Global Assessment (IGA) score with a score of 0 (clear) or 1\n(almost clear). At the end of the trial, treatment success rates and mean\npercentage changes, compared to the ASC40-303 baseline, were:\n\n Efficacy Endpoints                              Denifanstat 12wk /   Placebo 12wk /      Total (n=240)  \n                                                 Denifanstat 40wk     Denifanstat 40wk                   \n                                                 (n=116)              (n=124)                            \n Treatment success rate                          57.8%                55.6%               56.7%          \n Mean % change in total lesion count             -73.0%               -70.7%              -71.8%         \n Mean % change in inflammatory lesion count      -78.1%               -75.8%              -76.9%         \n Mean % change in non-inflammatory lesion count  -68.3%               -65.5%              -66.9%         \n\nNote: Total skin lesion counts and inflammatory skin lesion counts reduced by\napproximately 75% and 80%, respectively, compared to ASC40-303 baseline for\npatients who completed the OLE trial.\n\nDenifanstat was generally well-tolerated in the OLE with patients receiving up\nto 52 weeks of exposure, with no permanent discontinuations of study drug due\nto adverse events and no drug-related serious adverse events among patients\ntreated with denifanstat. Only two categories of treatment-related adverse\nevents had an incidence of more than 5% over the 52-week period: dry skin in\n7.1% and dry eye in 5.9%.\n\n\"The positive results presented today at EADV reinforce our confidence in\ndenifanstat as we prepare to begin patient screening for our U.S. AURORA Phase\n3 clinical trial in October, with first patient enrollment expected shortly\nthereafter,\" said David Happel, Chief Executive Officer of Sagimet. \"Annually\napproximately ten million people in the U.S. live with moderate to severe\nacne. Denifanstat, if approved, could offer a convenient, once-daily oral\nmedication for this underserved patient population, and would be the first\noral treatment with a novel mechanism of action approved for acne in more than\nforty years.\"\n\n\"The open-label extension trial provides important data to support our AURORA\nPhase 3 program,\" said Andreas Grauer, MD, Chief Medical Officer of Sagimet.\n\"It is particularly encouraging that patients continued to improve with longer\ntreatment, and denifanstat remained generally well-tolerated through the\nopen-label extension trial, with exposure to denifanstat up to 52 weeks.\nNotably, patients who crossed over from placebo achieved treatment success\nrates similar to those treated with denifanstat from the start. Together,\nthese results provide meaningful long-term experience with the 50 mg\ndenifanstat dose we are taking forward in AURORA.\"\n\nVirtual Key Opinion Leader Conference Call Information\n\nSagimet Biosciences will host a virtual KOL event with Julie Harper, MD,\nFounding Director and past President of the American Acne and Rosacea Society\non September 30, 2026 at 1 PM ET.\n\nDr. Harper will join company management for a review of the 52-week data from\nlicense partner Ascletis’ Phase 3 open-label extension clinical trial of\ndenifanstat in moderate to severe acne vulgaris in China and an update on the\ncompany’s planned U.S. Phase 3 AURORA clinical trial of denifanstat for the\ntreatment of moderate to severe acne. Live webcast available: LINK\n(https://www.globenewswire.com/Tracker?data=Fg3el_MEq-_rMIP9-kvBdMov2VH23QCXqHiw41CaNCR2fgk3e4mLlMjcmA47sSbQpBtjFzJ0nsjMLzetboz-Viid8grEG6tCPaGlqvP7Y7IOeQeWR-rxVMR74XgueN-_U0SGsaaUdsTLzjRGTxxJYKQrEU6d1aB9ImryauigEfw1yecrefH8I29G9IZPt8H8zAjiXOHc5FgNgNKRDOB89qa79k3G18r_pThC9sRyG2Kg-9-fCAGR-Ig4WZvGTkiStLRfBFIduBvRMUHO6_XI0sdSZpNKmW1ztHiL63wbUTlQt4VyKHbNvrT_lpwdtyipxWNtGl3s9zZiGjK5T68xiJ-n9kcs37sPxWx57fOBn5nBbLRiLzy3_7CU44Z4_83cxzQooS8NcazHVciniaXvNTRzRlkkxmIMzcpVCDnvGaQoHrlZ5g2aOCLPo2BRVIok)\n\nAbout the Ascletis Phase 3 Clinical Trial and Open-Label Extension\n\nASC40-303 (NCT06192264) was a randomized, double-blind, placebo-controlled\n12-week Phase 3 clinical trial of denifanstat in 480 patients with moderate to\nsevere acne vulgaris, conducted in China by Ascletis. Patients were randomized\n1:1 to denifanstat 50 mg or placebo once daily. Denifanstat met all primary\nand secondary endpoints and was generally well-tolerated.\n\nASC40-304 (NCT06248008) was a multi-center, open-label Phase 3 extension\nevaluating the long-term safety of denifanstat in patients with moderate to\nsevere acne vulgaris who were previously enrolled in the double-blind,\nrandomized, placebo-controlled 12-week Phase 3 ASC40-303 trial. This\nopen-label Phase 3 trial enrolled 240 subjects that received oral denifanstat\n50 mg once daily for up to 40 weeks. Subjects who were originally randomized\nto denifanstat in ASC40-303 trial had a total of up to 52 weeks of denifanstat\nexposure. Primary endpoints evaluated safety, and secondary endpoints\nevaluated efficacy, including reduction in IGA from baseline and reduction in\ntotal lesion count and inflammatory lesion count from baseline for up to 52\nweeks of denifanstat treatment. Denifanstat was generally well-tolerated.\nSubjects treated with denifanstat showed improvements in all efficacy\nendpoints (secondary endpoints of the trial) beyond those observed at 12\nweeks. \n\nAbout the AURORA Phase 3 Clinical Trial\n\nThe AURORA multi-center, randomized, double-blind, placebo-controlled Phase 3\nclinical trial of denifanstat in moderate to severe acne is intended to enroll\napproximately 800 U.S. patients aged 12 years and older, of which 450 are\nexpected to be adolescents aged 12 to 17 years. Patients will be randomized\n2:1 to receive denifanstat 50 mg or placebo once daily for 12 weeks. The trial\nwill have three co-primary endpoints that will be assessed at week 12: the\nproportion of patients achieving treatment success in a global assessment\nscore, defined as at least a 2-point reduction from baseline with a score of 0\n(clear) or 1 (almost clear); absolute change in inflammatory skin lesion\ncounts from baseline; and absolute change in non-inflammatory skin lesion\ncounts from baseline. A subset of approximately 530 patients completing the\ndouble-blind period will be eligible to enter a 40-week open-label extension\nevaluating the long-term safety of denifanstat.\n\nAbout Denifanstat\n\nDenifanstat is an oral, once-daily FASN inhibitor in development for the\ntreatment of moderate to severe acne. In trials conducted by Sagimet’s\nlicense partner, Ascletis BioScience Co. Ltd. (Ascletis) in China,\ndenifanstat met all primary and secondary endpoints in a 12 week randomized,\ndouble-blind Phase 3 clinical trial in moderate to severe acne vulgaris and\nwas generally well-tolerated and showed improvements in all efficacy endpoints\nmeasured at 52 weeks (secondary endpoints of the trial) in an open-label\nextension clinical trial evaluating denifanstat’s long-term safety in\npatients with moderate to severe acne. Denifanstat is being developed\nby Ascletis as ASC40 for acne in China and by Sagimet in the rest of\nworld.\n\nAbout Acne\n\nAcne is one of the most common skin conditions in the U.S., with\napproximately 50 million Americans affected annually and more than 5 million\nseeking medical treatment for acne each year. Acne affects around 85% of\npersons between the ages of 12 and 24. Moderate to severe acne accounts for\n20% of acne sufferers, or approximately 10 million people in\nthe U.S. annually. There is no cure for acne, and due to its pathology, most\npatients require chronic management and multiple annual courses of treatment\nfor flare control.\n\nAbout Sagimet Biosciences\n\nSagimet is a clinical-stage biopharmaceutical company developing novel FASN\ninhibitors designed to target dysfunctional metabolic and fibrotic pathways in\nconditions resulting from the overproduction of the fatty acid, palmitate.\nFASN is a regulator of lipid synthesis, a key pathway implicated in multiple\ndiseases, such as acne, MASH and certain FASN-dependent tumor types. For\nadditional information about Sagimet, please visit www.sagimet.com.\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of,\nand made pursuant to the safe harbor provisions of, The Private Securities\nLitigation Reform Act of 1995. All statements contained in this press release,\nother than statements of historical facts or statements that relate to present\nfacts or current conditions, including but not limited to, statements\nregarding the expected timing of the presentation of data from ongoing\nclinical trials, Sagimet’s clinical development plans and related timelines\nand anticipated development milestones, are forward-looking statements. These\nstatements involve known and unknown risks, uncertainties and other important\nfactors that may cause Sagimet’s actual results, performance or achievements\nto be materially different from any future results, performance or\nachievements expressed or implied by the forward-looking statements. In some\ncases, these statements can be identified by terms such as “may,”\n“might,” “will,” “should,” “expect,” “plan,” “aim,”\n“seek,” “anticipate,” “could,” “intend,” “target,”\n“project,” “contemplate,” “believe,” “estimate,”\n“predict,” “forecast,” “potential” or “continue” or the\nnegative of these terms or other similar expressions. The forward-looking\nstatements in this press release are only predictions. Sagimet has based these\nforward-looking statements largely on its current expectations and projections\nabout future events and financial trends that Sagimet believes may affect its\nbusiness, financial condition and results of operations. These forward-looking\nstatements speak only as of the date of this press release and are subject to\na number of risks, uncertainties and assumptions, some of which cannot be\npredicted or quantified and some of which are beyond Sagimet’s control,\nincluding, among others: the clinical development and therapeutic potential of\ndenifanstat, TVB-3567 or any other drug candidates or combination therapies\ndeveloped by Sagimet; Sagimet’s ability to advance drug candidates into and\nsuccessfully complete clinical trials within anticipated timelines;\nSagimet’s relationship with Ascletis, and the success of its development and\nregistration efforts for denifanstat; the accuracy of Sagimet’s estimates\nregarding its capital requirements and Sagimet’s ability to maintain and\nsuccessfully enforce adequate intellectual property protection. These and\nother risks and uncertainties are described more fully in the “Risk\nFactors” section of Sagimet’s most recent filings with the Securities and\nExchange Commission and available at www.sec.gov. You should not rely on these\nforward-looking statements as predictions of future events. The events and\ncircumstances reflected in these forward-looking statements may not be\nachieved or occur, and actual results could differ materially from those\nprojected in the forward-looking statements. Moreover, Sagimet operates in a\ndynamic industry and economy. New risk factors and uncertainties may emerge\nfrom time to time, and it is not possible for management to predict all risk\nfactors and uncertainties that Sagimet may face. Except as required by\napplicable law, Sagimet does not plan to publicly update or revise any\nforward-looking statements contained herein, whether as a result of any new\ninformation, future events, changed circumstances or otherwise.\n\nInvestor Contact:\nJoyce Allaire \nLifeSci Advisors \nJAllaire@LifeSciAdvisors.com\n\nMedia Contact:\nMaggie Whitney\nLifeSci Communications\nmwhitney@lifescicomms.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e944daed-3f71-402b-bb23-82149e5c0d26)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-30T10:00:00.394690926Z","server_sent_at_ms":1790762400394},"received_at":"2026-09-30T10:00:00.449Z","source_url":null},"analysis":{"id":"145033","press_release_id":"156335","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["Open-label extension data lack a placebo control; placebo/denifanstat crossover arm showed nearly identical efficacy to continuous treatment","Data are from Ascletis' China trials, not directly from Sagimet's own U.S. pivotal program"],"eventType":"clinical_trial","narrative":"Sagimet announced positive 52-week results from the Phase 3 ASC40-304 open-label extension trial of denifanstat in moderate to severe acne, conducted in China by license partner Ascletis and presented at EADV 2026.\n\nIn the 240-patient OLE, treatment success was 56.7% overall, with mean total lesion reduction of 71.8% and inflammatory lesion reduction of 76.9%; denifanstat was generally well-tolerated with no adverse event-related permanent discontinuations over up to 52 weeks.\n\nThe data support the 50 mg dose Sagimet is taking into its U.S. AURORA Phase 3 trial, with patient screening expected to begin in October 2026 and roughly 800 patients planned.\n\nCEO David Happel noted approximately ten million Americans live with moderate to severe acne and that denifanstat, if approved, would be the first oral acne treatment with a novel mechanism approved in more than forty years.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Long-term safety and sustained efficacy de-risk denifanstat ahead of Sagimet's U.S. AURORA Phase 3 screening start in October."},"keyFigures":{"drugName":"denifanstat (ASC40)","phaseOfTrial":"Phase 3","customDimensions":{"ole_enrollment":240,"ole_duration_weeks":52,"total_lesion_reduction":"-71.8% mean change","aurora_planned_enrollment":800,"iga_treatment_success_rate":"56.7% (total n=240; 57.8% denifanstat/denifanstat, 55.6% placebo/denifanstat)","discontinuations_due_to_aes":0,"inflammatory_lesion_reduction":"-76.9% mean change"}},"quotedText":"Annually approximately ten million people in the U.S. live with moderate to severe acne. Denifanstat, if approved, could offer a convenient, once-daily oral medication for this underserved patient population, and would be the first oral treatment with a novel mechanism of action approved for acne in more than forty years.","namedEntities":{"people":[{"name":"David Happel","role":"CEO of Sagimet Biosciences"},{"name":"Andreas Grauer, MD","role":"Chief Medical Officer of Sagimet Biosciences"},{"name":"Julie Harper, MD","role":"KOL, Founding Director and past President of the American Acne and Rosacea Society"}],"products":["denifanstat","ASC40","TVB-3567"],"companies":[{"name":"Sagimet Biosciences Inc.","ticker":"SGMT","relationship":"filer"},{"name":"Ascletis BioScience Co. Ltd.","relationship":"license partner (China rights)"},{"name":"LifeSci Advisors","relationship":"investor relations contact"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Positive 52-week Phase 3 OLE data from license partner Ascletis supports denifanstat's long-term safety and efficacy in acne ahead of Sagimet's own U.S. AURORA Phase 3 screening start in October 2026. Data are from an open-label trial in China, not a Sagimet-controlled pivotal readout, so impact is meaningful but not binary."},"tickerRelevance":{"others":[],"primary":"SGMT"},"globalImportance":35,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap clinical-stage biotech","eventGravity":"positive Phase 3 OLE data from partner trial, not a pivotal readout","issuerAuthored":true,"deriskingSignal":"supports AURORA Phase 3 starting October 2026"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Sagimet announced positive 52-week results from the Phase 3 ASC40-304 open-label extension trial of denifanstat in moderate to severe acne, conducted in China by license partner Ascletis and presented at EADV 2026.\n\nIn the 240-patient OLE, treatment success was 56.7% overall, with mean total lesion reduction of 71.8% and inflammatory lesion reduction of 76.9%; denifanstat was generally well-tolerated with no adverse event-related permanent discontinuations over up to 52 weeks.\n\nThe data support the 50 mg dose Sagimet is taking into its U.S. AURORA Phase 3 trial, with patient screening expected to begin in October 2026 and roughly 800 patients planned.\n\nCEO David Happel noted approximately ten million Americans live with moderate to severe acne and that denifanstat, if approved, would be the first oral acne treatment with a novel mechanism approved in more than forty years.","key_figures":{"drugName":"denifanstat (ASC40)","phaseOfTrial":"Phase 3","customDimensions":{"ole_enrollment":240,"ole_duration_weeks":52,"total_lesion_reduction":"-71.8% mean change","aurora_planned_enrollment":800,"iga_treatment_success_rate":"56.7% (total n=240; 57.8% denifanstat/denifanstat, 55.6% placebo/denifanstat)","discontinuations_due_to_aes":0,"inflammatory_lesion_reduction":"-76.9% mean change"}},"named_entities":{"people":[{"name":"David Happel","role":"CEO of Sagimet Biosciences"},{"name":"Andreas Grauer, MD","role":"Chief Medical Officer of Sagimet Biosciences"},{"name":"Julie Harper, MD","role":"KOL, Founding Director and past President of the American Acne and Rosacea Society"}],"products":["denifanstat","ASC40","TVB-3567"],"companies":[{"name":"Sagimet Biosciences Inc.","ticker":"SGMT","relationship":"filer"},{"name":"Ascletis BioScience Co. Ltd.","relationship":"license partner (China rights)"},{"name":"LifeSci Advisors","relationship":"investor relations contact"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-30T10:00:08.914Z","global_importance":35,"audience_relevance":30,"importance_components":{"tickerTier":"small-cap clinical-stage biotech","eventGravity":"positive Phase 3 OLE data from partner trial, not a pivotal readout","issuerAuthored":true,"deriskingSignal":"supports AURORA Phase 3 starting October 2026"}},"durationMs":8429,"modelName":"glm-5.3-flashx"}}