Sagimet Biosciences(SGMT)

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Sagimet Biosciences(SGMT) - 2025 Q1 - Quarterly Results
2025-05-08 10:05
Exhibit 99.2 Targeting Metabolic Dysfunction with Novel Therapies to Treat M ASH, Acne & Cancer May 2025 Forward-Looking Statements and Disclaimer This presentation contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Reform Act of 1995. All statements contained in this document, other than statements of historical facts or statements that relate to pre: conditions, including but not limited to, statements regarding possible or assumed fu ...
Sagimet Biosciences(SGMT) - 2025 Q1 - Quarterly Report
2025-05-08 10:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41742 Sagimet Biosciences Inc. (Exact name of registrant as specified in its charter) (State or other jurisdi ...
Sagimet Biosciences Reports First Quarter 2025 Financial Results and Provides Corporate Updates
GlobeNewswire News Room· 2025-05-08 10:00
Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on denifanstat for treating metabolic dysfunction associated steatohepatitis (MASH), with promising results from recent clinical trials and plans for further studies [2][5]. Clinical Development - The Phase 2b FASCINATE-2 trial of denifanstat in MASH patients showed successful results, especially in F3 stage patients [2]. - Denifanstat demonstrated similar pharmacokinetic characteristics and tolerability in a Phase 1 trial for patients with and without hepatic impairment [2]. - A Phase 1 clinical trial to evaluate the combination of denifanstat and resmetirom is anticipated to start in the second half of 2025, with results expected in the first half of 2026 [3][12]. Preclinical Data - Preclinical data presented at EASL 2024 indicated that the combination of a FASN inhibitor (TVB-3664) and resmetirom significantly improved liver disease markers, achieving an 80% improvement in NAS compared to 33% and 25% improvements from monotherapies [3][6]. Financial Results - For the quarter ended March 31, 2025, Sagimet reported a net loss of $18.2 million, compared to a net loss of $6.6 million for the same period in 2024 [8][16]. - Research and development expenses increased to $15.3 million from $5.3 million year-over-year, while general and administrative expenses rose to $4.5 million from $3.5 million [12][16]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $144.6 million [12][17]. Corporate Updates - The company successfully completed end-of-Phase 2 interactions with the FDA in October 2024, paving the way for Phase 3 trials in MASH [5]. - Leadership changes include George Kemble transitioning to non-executive Chair of the Board and the appointment of Beth Seidenberg as Lead Independent Director [5]. Industry Context - MASH is a severe liver disease affecting over 115 million people globally, with limited treatment options available [10]. - The renaming of NAFLD to MASLD and NASH to MASH aims to reduce stigma and improve diagnosis [10].
Sagimet Biosciences Announces Upcoming Presentations at EASL Congress 2025
Newsfilter· 2025-04-23 12:00
SAN MATEO, Calif., April 23, 2025 (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 three poster presentations featuring additional analyses from the Phase 2b FASCINATE-2 study of denifanstat in MASH will be presented at the European Association for the Study of Liver (EASL) Congress 2025 being held May 7-10, 2025 in Amsterdam, Netherlands ...
Sagimet Biosciences(SGMT) - 2024 Q4 - Annual Results
2025-03-12 11:35
Financial Performance - Sagimet reported a net loss of $45.6 million for the full year ended December 31, 2024, compared to a net loss of $27.9 million for the previous year, representing a 63.5% increase in losses[11]. - Research and development expenses for the year were $38.4 million, up from $19.8 million in 2023, indicating a 93.1% increase year-over-year[11]. - Cash, cash equivalents, and marketable securities as of December 31, 2024, were $158.7 million, expected to fund operations for at least the next 12 months[11]. - Cash, cash equivalents, and marketable securities increased to $158,658 million in December 2024 from $94,897 million in December 2023, representing a growth of 67.5% [20]. - Total assets rose to $160,259 million in December 2024, up from $96,719 million in December 2023, indicating a growth of 65.7% [20]. - Current liabilities decreased to $4,454 million in December 2024 from $5,654 million in December 2023, reflecting a reduction of 21.1% [20]. - Stockholders' equity increased significantly to $155,805 million in December 2024, compared to $91,065 million in December 2023, marking a growth of 71.1% [20]. - Liabilities and stockholders' equity totaled $160,259 million in December 2024, consistent with total assets, indicating a balanced financial position [20]. Clinical Development - The company initiated its Phase 3 denifanstat program in metabolic dysfunction-associated steatohepatitis (MASH) in Q4 2024, with patient screening expected to start in the first half of 2025[11]. - Sagimet received Breakthrough Therapy designation from the FDA for denifanstat for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis in October 2024[7]. - The Phase 3 program for denifanstat will include two trials, FASCINATE-3 and FASCINIT, with a minimum of 1,800 patients expected to be exposed to denifanstat[11]. - The Phase 2b FASCINATE-2 trial of denifanstat met its primary efficacy endpoints, demonstrating significant improvements in disease activity and fibrosis[7]. - The company plans to seek accelerated approval for denifanstat based on 52-week data from the FASCINATE-3 trial[11]. - Sagimet announced the clearance of its IND application for TVB-3567, a second FASN inhibitor, for the treatment of acne, with a Phase 1 trial anticipated to start in 2025[4]. Financing Activities - The company completed a follow-on offering of 9,000,000 shares in January 2024, resulting in net proceeds of $104.7 million[8].
Sagimet Biosciences(SGMT) - 2024 Q4 - Annual Report
2025-03-12 11:30
Financial Performance - The company incurred net losses of $45.6 million and $27.9 million for the years ended December 31, 2024, and 2023, respectively[356]. - Cash, cash equivalents, and marketable securities were $158.7 million and $94.9 million as of December 31, 2024, and 2023, respectively[356]. - The company anticipates additional losses and negative cash flows from operations for at least the next 12 months[363]. Product Development and Clinical Trials - The company currently has no products approved for commercial sale and has not generated any revenue to date[357]. - The company is exploring various funding alternatives to complete the Phase 3 program for its lead drug candidate, denifanstat[363]. - Denifanstat is currently under development for MASH, with significant uncertainties regarding its therapeutic benefits and long-term safety issues[65]. - The company is facing challenges in enrolling sufficient patients for clinical trials, which could delay the development process[370]. - A Phase 3 clinical trial for denifanstat in treating moderate to severe acne vulgaris is set to enroll 480 patients, with completion expected in November 2024[384]. - The company has identified potential additional indications for denifanstat, but further studies may reveal harmful side effects or limited efficacy[384]. - The success of denifanstat in clinical trials is uncertain, as results from earlier trials may not predict outcomes in later-stage trials[376]. - The overall drug development process is lengthy and expensive, with a high likelihood of setbacks, particularly in advanced clinical trials[376]. Regulatory and Compliance Risks - The company has received Breakthrough Therapy designation for denifanstat, but this may not expedite the development or approval process[355]. - Regulatory approval processes are lengthy and unpredictable, and the company has not yet obtained approval for any drug candidate, which could substantially harm its business[401]. - The FDA may require additional studies or impose limitations on approved labeling, which could delay approval or increase costs[402]. - Obtaining regulatory approval in one jurisdiction does not guarantee approval in others, and failure to comply with foreign regulatory requirements could harm market potential[404]. - The acceptance of data from foreign clinical trials by the FDA is subject to conditions, and there is no assurance that such data will be accepted, which could lead to costly and time-consuming additional trials[386]. - Compliance with Good Clinical Practice (GCP) regulations is mandatory, and failure to comply may result in the need for additional clinical trials, delaying the approval process[497]. Competition and Market Challenges - The future success of the company is heavily dependent on the regulatory approval and commercialization of denifanstat for MASH[366]. - The company may not be able to successfully commercialize denifanstat even if it receives regulatory approval due to competition and market acceptance issues[369]. - Competition in the pharmaceutical industry is intense, with companies like Madrigal Pharmaceuticals having received FDA approval for similar treatments[426]. - Future competition may arise from various pharmaceutical and biotechnology companies developing treatments for MASH, increasing market challenges[427]. Intellectual Property and Patent Risks - The company’s success is heavily dependent on obtaining and maintaining sufficient patent protection for its drug candidates, which is subject to various uncertainties[451]. - The patent application process is complex and costly, and there is no guarantee that pending applications will result in issued patents[452]. - The company may face challenges in protecting its intellectual property if third parties file patent applications on similar technologies[455]. - Legal disputes to protect intellectual property could be costly and time-consuming, diverting management's attention[464]. - The company may not be able to identify all relevant third-party patents, which could adversely affect product development[471]. Financial and Funding Challenges - The company is considering strategic transactions such as mergers, acquisitions, and partnerships, which could increase capital requirements and dilute stockholder equity[448]. - Future acquisitions may require additional financing, which may not be available on favorable terms, potentially affecting the company's financial condition and liquidity[449]. - Legislative changes at both federal and state levels are increasingly aimed at controlling pharmaceutical pricing, which could negatively affect the company's financial condition and prospects[431]. Cybersecurity and Data Privacy Risks - The company may face significant cybersecurity risks that could lead to data breaches, impacting its operations and reputation[534]. - Cybersecurity incidents could result in liability and reputational harm, potentially delaying the development and commercialization of drug candidates[540]. - The company relies on third-party partners for clinical trials, which introduces new cybersecurity risks and vulnerabilities[537]. - The California Consumer Privacy Act (CCPA) allows for administrative fines of up to $7,500 per violation, increasing compliance costs and potential liabilities[545]. Manufacturing and Supply Chain Risks - The company does not control the manufacturing process of its drug candidates and is dependent on third-party manufacturers, which could lead to delays and increased costs if issues arise[508]. - The company has relied on three Contract Manufacturing Organizations (CMOs) in the U.S. and China for the production of denifanstat drug substance and product, with plans for additional material for late-stage studies[504]. - Changes in manufacturing processes may incur additional costs and delays, impacting clinical trial timelines and commercialization[421].
Sagimet Biosciences Reports Full Year 2024 Financial Results and Provides Corporate Updates
Newsfilter· 2025-03-12 11:30
Denifanstat Phase 3 MASH program initiated in Q4 2024; patient screening expected to start in 1H 2025 Denifanstat received Breakthrough Therapy designation from FDA for MASH Clearance of Investigational New Drug (IND) application for FASN Inhibitor TVB-3567, to be developed for the treatment of acne SAN MATEO, Calif., March 12, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (NASDAQ:SGMT), clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic ...
Sagimet Biosciences Announces Clearance of IND for FASN Inhibitor TVB-3567, to be Developed for the Treatment of Acne
Globenewswire· 2025-03-11 12:00
Core Viewpoint - Sagimet Biosciences Inc. has received clearance for its Investigational New Drug (IND) application for TVB-3567, a fatty acid synthase (FASN) inhibitor, which is set to enter clinical trials for acne treatment in 2025 [2][3]. Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [5]. - The company's lead drug candidate, denifanstat, is an oral FASN inhibitor in development for metabolic dysfunction associated with steatohepatitis (MASH) [5]. Product Development - TVB-3567 is a potent and selective small molecule FASN inhibitor aimed at treating acne, addressing the condition's primary contributor, sebum production [2][3]. - The planned Phase 1 clinical trial for TVB-3567 will be randomized, double-blind, and placebo-controlled, evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics [4]. Market Opportunity - Over 50 million people in the US suffer from acne, making it a prevalent skin disease [3]. - FASN inhibition is seen as a significant therapeutic target for acne, with the potential for a differentiated treatment option if approved [3].
Sagimet Biosciences' Denifanstat Should Be Worth More Today
Seeking Alpha· 2025-03-07 21:27
Core Insights - Sagimet Biosciences Inc. is focused on developing fatty acid synthase (FASN) inhibitors to address conditions related to excessive fatty acid palmitate production, with Denifanstat being the primary value driver [1] Company Overview - Sagimet Biosciences Inc. trades on NASDAQ under the ticker SGMT and has been under observation since April of the previous year [1] Product Development - The company is advancing its research on FASN inhibitors, which are aimed at treating specific health conditions linked to fatty acid production [1]
Sagimet Biosciences Announces Oral Presentation at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium
Globenewswire· 2025-02-19 13:00
Core Insights - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics targeting metabolic and fibrotic pathways, with its lead drug candidate denifanstat showing promise in treating metabolic dysfunction associated steatohepatitis (MASH) [1][3] Company Overview - Sagimet is developing novel fatty acid synthase (FASN) inhibitors aimed at addressing diseases caused by the overproduction of palmitate [3] - Denifanstat is an oral, once-daily selective FASN inhibitor currently in development for MASH, having completed a successful Phase 2b clinical trial (FASCINATE-2) with positive results [3] - The FDA has granted Breakthrough Therapy designation to denifanstat for treating non-cirrhotic MASH with moderate to advanced liver fibrosis, supporting its advancement into Phase 3 development [3] Upcoming Presentation - An oral presentation on denifanstat's effects on triglycerides and LDL-cholesterol in advanced fibrosis patients will be delivered at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium on February 26, 2025 [1][2] - The presentation will include lipidomic data from a post-hoc analysis of the Phase 2b FASCINATE-2 trial [1][2] 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 improve diagnostic clarity and reduce stigma [4]