Financial Performance - License revenue for the three months ended September 30, 2024 was $0, a decrease of 100% compared to $2.0 million in the same period of 2023[104] - License revenue for the nine months ended September 30, 2024 was $0, a decrease of $2.0 million or 100% compared to the same period in 2023[109] - Net loss for the three months ended September 30, 2024 was $14.6 million, an increase of 130% compared to a net loss of $6.4 million in the same period of 2023[104] - Other income increased by $5.3 million for the nine months ended September 30, 2024, primarily from increased interest income related to cash proceeds from the IPO and follow-on offering[112] Operating Expenses - Total operating expenses for the three months ended September 30, 2024 were $16.9 million, an increase of 79% compared to $9.5 million in the same period of 2023[104] - Research and development expenses increased by $7.7 million, or 155%, for the three months ended September 30, 2024, primarily due to clinical trial expenses related to the Phase 3 program of denifanstat[105] - General and administrative expenses decreased by $0.2 million, or 5%, for the three months ended September 30, 2024, primarily due to a decrease in stock-based compensation and tax expenses[106] - Research and development expenses increased by $10.1 million, or 72%, for the nine months ended September 30, 2024, primarily due to increased manufacturing and clinical trial costs[110] - General and administrative expenses rose by $2.9 million, or 31%, for the nine months ended September 30, 2024, mainly due to higher professional fees and personnel-related expenses[111] Cash Flow - Net cash used in operating activities was $31.4 million for the nine months ended September 30, 2024, compared to $16.7 million for the same period in 2023[126] - Net cash used in investing activities was $71.5 million for the nine months ended September 30, 2024, primarily for purchases of marketable securities[129] - Net cash provided by financing activities was $104.8 million for the nine months ended September 30, 2024, mainly from the sale of Series A common stock in the January 2024 follow-on offering[130] - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $170.0 million[117] Future Expectations - The company expects research and development expenses to increase substantially as it advances drug candidates through clinical trials and regulatory approval[99] - The company anticipates significant expenses in the foreseeable future as it advances drug candidates through clinical trials and expands corporate infrastructure[117] - The company expects to finance future cash needs through public or private equity or debt financings, collaborations, and strategic alliances[118] Clinical Development - Denifanstat achieved a primary endpoint of ≥2-point reduction in NAS (NAFLD Activity Score) without worsening of fibrosis in 52% of patients compared to 20% in the placebo group, with a p-value of 0.0003[82] - The Phase 3 program for denifanstat is expected to comprise a minimum of 1,800 patients and is anticipated to initiate by the end of 2024[93] - The FDA granted Breakthrough Therapy designation to denifanstat for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis in October 2024[90] - Denifanstat showed a statistically significant increase in beneficial polyunsaturated triglycerides of +42% compared to -4% in the placebo group at the end of 52 weeks of treatment[89] Company Classification - The company is classified as a "smaller reporting company" with a market value of stock held by non-affiliates below $700 million and annual revenue under $100 million[137] - The company may continue to qualify as a smaller reporting company if the market value of stock held by non-affiliates remains below $250 million or if annual revenue stays under $100 million while the market value is below $700 million[137] - As a smaller reporting company, the company can present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K[137] - The company has reduced disclosure obligations regarding executive compensation due to its smaller reporting company status[137] - The company is not required to provide quantitative and qualitative disclosures about market risk as defined by Rule 12b-2 of the Securities Exchange Act of 1934[138]

Group 1 - Sagimet Biosciences Inc. (NASDAQ: SGMT) has shown significant improvement and is positioned as a potential leader in innovative therapies for metabolic dysfunction-associated steatohepatitis (MASH) [1] - The company may soon explore additional applications in dermatology and oncology [1] - A Strong Buy rating was previously issued in July, indicating positive sentiment towards the company's prospects [1]

Core Insights - Sagimet Biosciences announced significant results from the Phase 2b FASCINATE-2 clinical trial of denifanstat, showing improvements in disease activity, MASH resolution, and fibrosis, supporting its advancement to Phase 3 development [1][2][4] Company Overview - Sagimet Biosciences is a clinical-stage biopharmaceutical company focused on developing novel fatty acid synthase (FASN) inhibitors to target metabolic and fibrotic pathways [8] - Denifanstat is an oral, once-daily selective FASN inhibitor aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) [8] Clinical Trial Results - The FASCINATE-2 trial involved 168 biopsy-confirmed MASH patients with moderate-to-severe fibrosis, demonstrating statistically significant improvements in primary endpoints at week 52 [7] - Denifanstat-treated patients showed a 36% MASH resolution rate without worsening fibrosis compared to 13% in the placebo group (p=0.0044) [3] - A 52% reduction in NAS without worsening fibrosis was observed in denifanstat-treated patients versus 20% in placebo (p=0.0003) [3] Secondary Endpoints - Fibrosis improvement by ≥1 stage without worsening of steatohepatitis was seen in 41% of denifanstat-treated patients compared to 18% with placebo (p=0.0103) [5] - In patients with F3 fibrosis, 49% showed improvement with denifanstat versus 13% with placebo (p=0.0032) [5] - Non-invasive biomarkers indicated improvements in liver health, including decreased liver fat and liver enzymes [6] Safety Profile - No treatment-related serious adverse events were reported, with most adverse events being mild to moderate [6] - There were no Grade ≥3 treatment-related adverse events or signals of drug-induced liver injury [6] Future Development - Sagimet plans to initiate a Phase 3 program for denifanstat in 2024, following the positive results from the Phase 2b trial [4]

Company Overview - Sagimet Biosciences' stock increased by 12.6% following the FDA's breakthrough therapy designation for its lead candidate, denifanstat, aimed at treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1] - Denifanstat is an oral, once-daily pill that has shown statistically significant fibrosis reduction and delay in progression to cirrhosis in patients with moderate-to-advanced liver fibrosis [3] - Sagimet plans to initiate a phase III program for denifanstat by the end of 2024 [3] Industry Context - MASH, also known as nonalcoholic steatohepatitis (NASH), affects over 115 million people globally and can lead to severe liver conditions, creating a significant need for new therapies [6] - Currently, the only approved treatment for MASH is Madrigal Pharmaceuticals' Rezdiffra, which was launched in April 2023 [5] - The market for MASH is largely untapped, with several companies, including Viking Therapeutics, Akero Therapeutics, Eli Lilly, and Novo Nordisk, developing treatments for NASH/MASH [7][8][9]

Core Insights - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel fatty acid synthase (FASN) inhibitors to address metabolic dysfunction and fibrotic pathways [1][3] - The company will present data on its lead drug candidate, denifanstat, at the 8th Annual MASH Drug Development Summit, highlighting its anti-fibrotic activity in metabolic dysfunction-associated steatohepatitis (MASH) [1][2] Company Overview - Sagimet is developing denifanstat, an oral, once-daily selective FASN inhibitor aimed at treating MASH, with positive results from the completed Phase 2b clinical trial (FASCINATE-2) [3] - The company targets diseases caused by the overproduction of the fatty acid palmitate [3] Industry Context - MASH is a severe liver disease affecting over 115 million people globally, with only one recently approved treatment in the U.S. and none in Europe [4] - The renaming of non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to MASH aims to reduce stigma and provide a clearer diagnosis [4]

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. "We are thrilled to welcome Anne and Jennifer to our board as we prep ...

SAN MATEO, Calif., June 10, 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 it will host a conference call and webcast on Thursday, June 13, 2024, at 9.30 AM PT / 12:30 PM ET. Dr. Loomba will discuss positive data from Sagimet's FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in bi ...

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 Statistical significance also shown in improvement of liver fibrosis ≥2-stage without worsening of MASH in the mITT population, including in patients with baseline stage 3 fibrosis Tripalmitin, a biomarker of denifanstat activity, showed an early and sustained reduction in de nov ...

SAN MATEO, Calif., May 16, 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 it will host a virtual investor and analyst day on Thursday, May 23, 2024 at 1:00 PM ET. To register, click here. The event will feature Scott L. Friedman, MD (Icahn School of Medicine at Mount Sinai) who will discuss the unmet ne ...

SAN MATEO, Calif., May 16, 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 it will host a virtual investor and analyst day on Thursday, May 23, 2024 at 1:00 PM ET. To register, click here. The event will feature Scott L. Friedman, MD (Icahn School of Medicine at Mount Sinai) who will discuss the unmet ne ...