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4 hours ago
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Ascletis Announces Poster Presentations on the Study Results of ASC30 and ASC47 at the 85th Scientific Sessions of American Diabetes Association (ADA)
HONG KONG, June 8, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that poster presentations on preliminary studies of its oral small molecule GLP-1 Receptor (GLP-1R) agonist ASC30 and adipose-targeted, muscle-preserving weight loss drug candidate ASC47 will be presented at the 85th Scientific Sessions of American Diabetes Association (ADA) in Chicago, U.S. Details of the Poster Presentations Poster Number: 750-P Abstract Title: ASC30, an Oral GLP-1R Biased Small Molecule Agonist in Participants with Obesity—A First-in-Human Single Ascending Dose Study Session Type: General Poster Session Location: Poster Hall (Hall F1) Presentation Time: Sunday Jun 22, 2025 12:30 PM - 1:30 PM (Chicago Time), i.e., Monday Jun 23, 2025 1:30 AM - 2:30 AM (Beijing Time) Poster Number: 847-P Abstract Title: ASC47, a Muscle-Preserving Weight Loss Drug Candidate for Obesity, in Combination with Semaglutide, Demonstrated Superior Weight Loss to Semaglutide Monotherapy in a Preclinical Model Session Type: General Poster Session Location: Poster Hall (Hall F1) Presentation Time: Sunday Jun 22, 2025 12:30 PM - 1:30 PM (Chicago Time), i.e., Monday Jun 23, 2025 1:30 AM - 2:30 AM (Beijing Time) About ASC30 ASC30 is an investigational GLP-1R biased small molecule agonist and has unique and differentiated properties that enable the same small molecule for both oral tablet and subcutaneous injection administrations. ASC30 is a new chemical entity (NCE), with U.S. and global compound patent protection until 2044. About ASC47 ASC47 is an adipose-targeted, ultra-long-acting subcutaneously (SQ) injected thyroid hormone receptor beta (THRβ) selective small molecule agonist, discovered and developed in-house at Ascletis. ASC47 possesses unique and differentiated properties to enable adipose targeting, resulting in dose-dependent high drug concentrations in the adipose tissue. Topline data from its Phase Ib single subcutaneous injection studies in Australia in participants with elevated low-density lipoprotein cholesterol (LDL-C) (NCT06427590) have been released. The Phase I clinical trial of ASC47 in combination with semaglutide for the treatment of obesity (NCT06972992) is ongoing in the U.S., and the first participants were dosed in May 2025. About the American Diabetes Association (ADA) Established in 1940, the American Diabetes Association (ADA) is dedicated to preventing and curing diabetes and to improving the lives of all people affected by diabetes. It has grown into one of the foremost nonprofit organizations in diabetes advocacy around the world. Its annual Scientific Sessions set the agenda for clinical practice and research innovation. The 85th Scientific Sessions of ADA will be held in Chicago, U.S. from June 20 to 23, 2025. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange ( covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline. For more information, please visit Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) Ascletis Pharma Inc. PR and IR teams +86-181-0650-9129 (China) pr@ ir@ View original content: SOURCE Ascletis Pharma Inc.
Associated Press
8 hours ago
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- Associated Press
Ascletis Announces Poster Presentations on the Study Results of ASC30 and ASC47 at the 85th Scientific Sessions of American Diabetes Association (ADA)
HONG KONG, June 8, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, 'Ascletis') announces that poster presentations on preliminary studies of its oral small molecule GLP-1 Receptor (GLP-1R) agonist ASC30 and adipose-targeted, muscle-preserving weight loss drug candidate ASC47 will be presented at the 85th Scientific Sessions of American Diabetes Association (ADA) in Chicago, U.S. Details of the Poster Presentations Poster Number: 750-P Abstract Title: ASC30, an Oral GLP-1R Biased Small Molecule Agonist in Participants with Obesity—A First-in-Human Single Ascending Dose Study Session Type: General Poster Session Location: Poster Hall (Hall F1) Presentation Time: Sunday Jun 22, 2025 12:30 PM - 1:30 PM (Chicago Time), i.e., Monday Jun 23, 2025 1:30 AM - 2:30 AM (Beijing Time) Poster Number: 847-P Abstract Title: ASC47, a Muscle-Preserving Weight Loss Drug Candidate for Obesity, in Combination with Semaglutide, Demonstrated Superior Weight Loss to Semaglutide Monotherapy in a Preclinical Model Session Type: General Poster Session Location: Poster Hall (Hall F1) Presentation Time: Sunday Jun 22, 2025 12:30 PM - 1:30 PM (Chicago Time), i.e., Monday Jun 23, 2025 1:30 AM - 2:30 AM (Beijing Time) About ASC30 ASC30 is an investigational GLP-1R biased small molecule agonist and has unique and differentiated properties that enable the same small molecule for both oral tablet and subcutaneous injection administrations. ASC30 is a new chemical entity (NCE), with U.S. and global compound patent protection until 2044. About ASC47 ASC47 is an adipose-targeted, ultra-long-acting subcutaneously (SQ) injected thyroid hormone receptor beta (THRβ) selective small molecule agonist, discovered and developed in-house at Ascletis. ASC47 possesses unique and differentiated properties to enable adipose targeting, resulting in dose-dependent high drug concentrations in the adipose tissue. Topline data from its Phase Ib single subcutaneous injection studies in Australia in participants with elevated low-density lipoprotein cholesterol (LDL-C) ( NCT06427590 ) have been released. The Phase I clinical trial of ASC47 in combination with semaglutide for the treatment of obesity ( NCT06972992 ) is ongoing in the U.S., and the first participants were dosed in May 2025. About the American Diabetes Association (ADA) Established in 1940, the American Diabetes Association (ADA) is dedicated to preventing and curing diabetes and to improving the lives of all people affected by diabetes. It has grown into one of the foremost nonprofit organizations in diabetes advocacy around the world. Its annual Scientific Sessions set the agenda for clinical practice and research innovation. The 85th Scientific Sessions of ADA will be held in Chicago, U.S. from June 20 to 23, 2025. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange ( covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline. For more information, please visit Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) [email protected] Ascletis Pharma Inc. PR and IR teams +86-181-0650-9129 (China) [email protected] [email protected] View original content: SOURCE Ascletis Pharma Inc.
Yahoo
9 hours ago
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Ascletis Announces Poster Presentations on the Study Results of ASC30 and ASC47 at the 85th Scientific Sessions of American Diabetes Association (ADA)
HONG KONG, June 8, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that poster presentations on preliminary studies of its oral small molecule GLP-1 Receptor (GLP-1R) agonist ASC30 and adipose-targeted, muscle-preserving weight loss drug candidate ASC47 will be presented at the 85th Scientific Sessions of American Diabetes Association (ADA) in Chicago, U.S. Details of the Poster Presentations Poster Number: 750-P Abstract Title: ASC30, an Oral GLP-1R Biased Small Molecule Agonist in Participants with Obesity—A First-in-Human Single Ascending Dose Study Session Type: General Poster Session Location: Poster Hall (Hall F1) Presentation Time: Sunday Jun 22, 2025 12:30 PM - 1:30 PM (Chicago Time), i.e., Monday Jun 23, 2025 1:30 AM - 2:30 AM (Beijing Time) Poster Number: 847-P Abstract Title: ASC47, a Muscle-Preserving Weight Loss Drug Candidate for Obesity, in Combination with Semaglutide, Demonstrated Superior Weight Loss to Semaglutide Monotherapy in a Preclinical Model Session Type: General Poster Session Location: Poster Hall (Hall F1) Presentation Time: Sunday Jun 22, 2025 12:30 PM - 1:30 PM (Chicago Time), i.e., Monday Jun 23, 2025 1:30 AM - 2:30 AM (Beijing Time) About ASC30 ASC30 is an investigational GLP-1R biased small molecule agonist and has unique and differentiated properties that enable the same small molecule for both oral tablet and subcutaneous injection administrations. ASC30 is a new chemical entity (NCE), with U.S. and global compound patent protection until 2044. About ASC47 ASC47 is an adipose-targeted, ultra-long-acting subcutaneously (SQ) injected thyroid hormone receptor beta (THRβ) selective small molecule agonist, discovered and developed in-house at Ascletis. ASC47 possesses unique and differentiated properties to enable adipose targeting, resulting in dose-dependent high drug concentrations in the adipose tissue. Topline data from its Phase Ib single subcutaneous injection studies in Australia in participants with elevated low-density lipoprotein cholesterol (LDL-C) (NCT06427590) have been released. The Phase I clinical trial of ASC47 in combination with semaglutide for the treatment of obesity (NCT06972992) is ongoing in the U.S., and the first participants were dosed in May 2025. About the American Diabetes Association (ADA) Established in 1940, the American Diabetes Association (ADA) is dedicated to preventing and curing diabetes and to improving the lives of all people affected by diabetes. It has grown into one of the foremost nonprofit organizations in diabetes advocacy around the world. Its annual Scientific Sessions set the agenda for clinical practice and research innovation. The 85th Scientific Sessions of ADA will be held in Chicago, U.S. from June 20 to 23, 2025. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange ( covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline. For more information, please visit Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) Ascletis Pharma Inc. PR and IR teams +86-181-0650-9129 (China) pr@ ir@ View original content: SOURCE Ascletis Pharma Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
5 days ago
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Sagimet's Partner Achieves Positive Results With Oral Acne Drug In Phase 3 Trial In China, Stock Jumps
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 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: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 © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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5 days ago
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Sagimet Biosciences Announces Positive Phase 3 Results for Denifanstat for the Treatment of Moderate-to-Severe Acne from Partner Ascletis
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 Endpoints 50mg denifanstat, oral, once daily(n=240) Placebo, oral, once daily(n=240) Placeboadjusted p value % Treatment success (IGA) 33.2 14.6 18.6 <0.0001 % Change in total lesion count -57.4 -35.4 -22.0 <0.0001 % Change in inflammatory lesion count -63.5 -43.2 -20.3 <0.0001 % Change in non-inflammatory lesion count -51.9 -28.9 -23.0 <0.0001 Absolute change in total lesion count -58.3 -36.2 -22.1 <0.0001 Absolute change in inflammatory lesion count -26.6 -18.4 -8.2 <0.0001 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 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 Bickers DR, Lim HW, Margolis D, Weinstock MA, Goodman C, Faulkner E et al. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. Journal of the American Academy of Dermatology 2006;55:490-500. American Academy of Dermatology/Milliman. Burden of Skin Disease. 2017. Purvis CG, Balogh EA, Feldman SR. Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the Acne Treatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055. 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 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 JAllaire@ Media Contact:Michael FitzhughLifeSci Advisors mfitzhugh@
