Sagimet Biosciences Inc

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Sagimet Biosciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of novel therapeutics for the treatment of infectious diseases. Its lead drug candidate, denifanstat, is an oral, once-daily pill and selective fatty acid synthase (FASN) inhibitor in development for the treatment of nonalcoholic steatohepatitis (NASH). The company was founded by Urs F. Greber, Ari Helenius, and Lucas Pelkmans on December 19, 2006 and is headquartered in San Mateo, CA.

Sagimet Biosciences Inc.'s Initiation of the phase 3 FASCINIT and FASCINATE-3 studies, using denifanstat for treatment of patients with MASH/MAFLD & MASH respectively, expected before the end of 2024. The global acne treatment market size is projected to grow from $17.48 billion by 2032. Results from phase 3 study by partner Ascletis, using denifanstat for treatment of patients with Acne Vulgaris, expected by Q2 of 2025.

Sagimet: More Than Just A MASH Drug Development Biotech

-Phase III trial enrolled a total of 480 patients with moderate to severe acne -Topline results expected in the second quarter 2025 HANGZHOU, China , Nov. 12, 2024 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces completion of enrollment of 480 patients for Phase III clinical trial of ASC40 (denifanstat) o nce-daily oral tablet for treatment of moderate to severe acne. The first patient was enrolled on January 24, 2024.

Ascletis Completes Enrollment of Phase III Trial of ASC40 (Denifanstat) Once-Daily Oral Tablet for Treatment of Acne

Sagimet Biosciences' Denifanstat shows significant potential in treating MASH, with FDA Breakthrough Therapy designation and peer-reviewed validation, supporting a "Strong Buy" rating. Denifanstat's unique FASN inhibition mechanism effectively reduces liver fibrosis, positioning it as a superior treatment for advanced MASH compared to competitors like Tirzepatide. SGMT's robust financials, including $188.5 million in liquidity and no debt, provide a solid foundation for advancing Denifanstat through Phase 3 trials.

Sagimet Soars: FDA Breakthrough Therapy Designation And Lancet Review Validate Denifanstat

- Treatment with denifanstat achieved statistically significant and clinically meaningful improvements in disease activity, MASH resolution and fibrosis - - Results support advancement of denifanstat into Phase 3 development -

Sagimet Biosciences Announces Publication of Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 MASH in The Lancet Gastroenterology & Hepatology

FDA's breakthrough therapy designation for SGMT's denifanstat for MASH with moderate-to-advanced liver fibrosis is based on phase IIb FASCINATE-2 study data.

SGMT Stock Up 12.6% on FDA Fast Track for Liver Disease Drug

Supported by positive data from Phase 2b FASCINATE-2 trial of denifanstat in patients with MASH Preparations are ongoing to initiate Phase 3 program for denifanstat by the end of 2024 SAN MATEO, Calif., Oct. 01, 2024 (GLOBE NEWSWIRE) --  Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to denifanstat for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in MASH

SAN MATEO, Calif., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced that management will participate in a virtual fireside chat at the H.C. Wainwright 8th Annual MASH Virtual Conference at 2:30 PM ET on Monday, October 7, 2024.

Sagimet Biosciences to Present at the H.C. Wainwright 8th Annual MASH Virtual Conference and Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

SAN MATEO, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced that an oral presentation highlighting denifanstat's anti-fibrotic activity in metabolic dysfunction-associated steatohepatitis (MASH) will be given at the 8th Annual MASH Drug Development Summit being held in Boston on September 24-26, 2024.

Sagimet Announces Oral Presentation at the 8th Annual MASH Drug Development Summit

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SAN MATEO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the appointments of two biotechnology industry leaders, Anne Phillips and Jennifer Jarrett, to the board of directors of the Company, effective August 1, 2024.

Sagimet Biosciences Announces Appointment of Anne Phillips and Jennifer Jarrett to its Board of Directors

Sagimet Biosciences is progressing with Denifanstat research targeting MASH, acne, and cancer with promising Phase 2b trial results. Denifanstat is progressing toward Phase 3 trials, with positive results reinforcing its potential, especially for hepatic-impaired patients. Eli Lilly's Tirzepatide presents strong competition for Denifanstat in MASH treatment, showing higher efficacy in recent trials.

Sagimet Biosciences' Denifanstat Remains A Strong Buy Despite Eli Lilly's Tirzepatide

Call scheduled on Thursday, June 13, 2024 at 9.30 AM PT / 12:30 PM ET Call scheduled on Thursday, June 13, 2024 at 9.30 AM PT / 12:30 PM ET

Sagimet Biosciences to Host Conference Call and Webcast to Discuss Recently Presented Data from ITT and F3 Patient Population in Phase 2b FASCINATE-2 Clinical Trial of Denifanstat

Denifanstat achieved statistically significant results on primary and secondary liver biopsy endpoints in the ITT population, including both histology endpoints recommended in the FDA draft guidance for accelerated approval in MASH

Sagimet Biosciences Presents Data from ITT and F3 Patient Population in Phase 2b FASCINATE-2 Clinical Trial of Denifanstat at EASL International Liver Congress 2024

Dr. Scott Friedman to present unmet need in MASH and discuss Sagimet's topline data from its FASCINATE-2 Phase 2b clinical trial of denifanstat in MASH Dr. Scott Friedman to present unmet need in MASH and discuss Sagimet's topline data from its FASCINATE-2 Phase 2b clinical trial of denifanstat in MASH

Sagimet Biosciences to Host Virtual Investor and Analyst Day on Inhibiting Fatty Acid Synthase (FASN) to Reduce Liver Fat, Inflammation and Fibrosis in MASH on May 23, 2024

Denifanstat Phase 2b FASCINATE-2 clinical data to be presented as an oral presentation at the EASL International Liver Congress 2024 taking place in Milan, Italy from June 5-8, 2024

Sagimet Biosciences Reports First Quarter 2024 Financial Results and Provides Corporate Updates

SAN MATEO, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced a General Session oral presentation of denifanstat Phase 2b FASCINATE-2 study data in metabolic dysfunction-associated steatohepatitis (MASH) will be given at the European Association for the Study of the Liver (EASL) International Liver Congress 2024 held in Milan, Italy from June 5-8, 2024.

Sagimet Announces Oral Presentation of Data from the Phase 2b FASCINATE-2 Study of Denifanstat in MASH at EASL International Liver Congress 2024

SAN MATEO, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the appointment of Thierry Chauche as Chief Financial Officer, effective today, May 6, 2024.

Sagimet Biosciences Announces Appointment of Thierry Chauche as Chief Financial Officer

Sagimet Biosciences is a clinical-stage biopharmaceutical company researching a cure for metabolic dysfunction-related diseases by inhibiting fatty acid synthase. Revenue generated so far comes from licensing agreements, and no product sales are anticipated in the near future. SGMT's leading drug candidate, denifanstat, is progressing to phase 3 with successful trial results, targeting MASH, a leading cause of liver transplants.

Sagimet Biosciences' Denifanstat Imminent Phase 3: A Promising Investment Opportunity

Sagimet announced positive topline data from its FASCINATE-2 Phase 2b clinical trial of denifanstat in MASH in January 2024 and plans to initiate Phase 3 trial in the second half of 2024 Sagimet announced positive topline data from its FASCINATE-2 Phase 2b clinical trial of denifanstat in MASH in January 2024 and plans to initiate Phase 3 trial in the second half of 2024

Sagimet Biosciences to Host Virtual Investor and Analyst Day on Inhibiting Fatty Acid Synthase (FASN) to Reduce Liver Fat, Inflammation and Fibrosis in MASH on May 3, 2024

SAN MATEO, Calif., March 27, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the completion of a Phase 1 hepatic impairment study with denifanstat, a selective FASN inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

Sagimet Biosciences Announces Completion of Phase 1 Hepatic Impairment Study with FASN Inhibitor Denifanstat

SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the appointments of two biotechnology industry leaders, Tim Walbert and Paul Hoelscher, to the board of directors of the Company, effective April 1, 2024.

Sagimet Biosciences Announces Appointment of Tim Walbert and Paul Hoelscher to its Board of Directors

Reported positive topline data from the Phase 2b FASCINATE-2 trial; at week 52 denifanstat met both primary efficacy endpoints and demonstrated statistically significant reduction in fibrosis

Sagimet Biosciences Reports Full Year 2023 Financial Results and Provides Corporate Updates

SAN MATEO, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced that management will participate in two upcoming investor conferences.

Sagimet Biosciences to Participate in Two Upcoming Investor Conferences

SAN MATEO, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (“Sagimet”) (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the pricing of its underwritten public offering of 9,000,000 shares of its Series A common stock at a public offering price of $12.50 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $112.5 million. In addition, Sagimet has granted the underwriters a 30-day option to purchase up to an additional 1,350,000 shares of its Series A common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the offering are to be sold by Sagimet. The offering is expected to close on January 30, 2024, subject to the satisfaction of customary closing conditions.

Sagimet Biosciences Announces Pricing of Public Offering of Series A Common Stock

Primary endpoints and multiple secondary endpoints met in phase 2b FASCINATE study, using denifanstat for F2-F3 NASH patients with statistical significance. An end of phase 2 meeting and phase 3 trial initiation using denifanstat for the treatment of NASH patients with related fibrosis, is expected in 2024. The global non-alcoholic steatohepatitis market is expected to reach $20 billion by 2029.

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