AbstractBackground: ASC63 is an oral small molecule programmed cell death-ligand 1 (PD-L1) inhibitor. After oral dosing, ASC63 is rapidly absorbed and converted to its pharmacologically active metabolite ASC63-A in vivo. In vitro studies showed that ASC63-A could activate PD-L1 dimerization and internalization from cell membrane, thus interfere PD-1/PD-L1 interaction and enhance T-cell activation. Here we report the in vivo antitumor efficacy of ASC63 in a humanized mouse tumor model.Methods: 0.5×106 human PD-L1 knock in CT26 cells (CT26-hPD−L1) were implanted subcutaneously into BALB/c mice for tumor development. When the average tumor volume reached approximately 100 mm3, mice were randomly assigned (post-grouping, PG) and treated with vehicle, reference drug (10 mg/kg Atezolizumab intravenous injection twice a week [BIW]), 50 or 100 mg/kg ASC63 oral dosing twice a day (BID) for 18 days. Body weights and tumor volumes were measured regularly, and tumor growth inhibitions (TGI) of different groups were compared. TGI was calculated using the formula: TGI (%) =[1-(TRTV-1)/(CRTV-1)] ×100, where TRTV= mean relative tumor volume (RTV) of treatment group; CRTV= mean of control group.Results: At PG-D18, the tumor volume of vehicle group reached 1548 mm3, and Atezolizumab, 50 and 100 mg/kg AS63 groups showed TGI values of 35.17, 17.12 and 36.87%, respectively. Atezolizumab 10 mg/kg BIW and ASC63 100 mg/kg BID produced similar antitumor activities. One mouse in 100 mg/kg ASC63 group had body weight loss more than 10% at PG-D6, and was back to normal at PG-D9 after extra nutrition was provided, while the rest of mice showed a gradually increase in body weight during the study. No significant difference of body weight or body weight change was found among different groups of mice.Conclusion: Results of this study show that ASC63 is in general well tolerated in CT26-hPD−L1 humanized mouse tumor model, and ASC63 has comparable antitumor efficacy as the FDA-approved PD-L1 antibody, Atezolizumab. ASC63 is an oral small molecule PD-L1 inhibitor, and thus will have better patient compliance than injective PD-1/PD-L1 antibody. Results of this study support the continued investigation of ASC63.Citation Format: Jinzi J. Wu, Handan He. In vivo antitumor efficacy evaluation of ASC63, an oral small molecule PD-L1 inhibitor, in a humanized mouse tumor model [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 6360.

2022-06-15·Cancer Research

Abstract 5529: In vivo efficacy evaluation of ASC61, an oral PD-L1 inhibitor, in two tumor mouse models

作者: He, Handan ; Wu, Jinzi J.

AbstractBackground: ASC61 is an oral inhibitor prodrug of programmed cell death-ligand 1 (PD-L1). ASC61 is converted to its pharmacologically active metabolite ASC61-A in the plasma. In vitro studies showed that ASC61-A could activate PD-L1 dimerization and membrane PD-L1 protein internalization, interfere PD-1/PD-L1 interaction and enhance T-cell activation. Here we report the in vivo efficacy of ASC61 in two tumor mouse models. ASC61 was found to have the best antitumor activity among all test drugs in the syngeneic tumor mouse model, BALB/c mice bearing CT-26-hPD-L1 tumors. Then a humanized mouse model, PD-1/PD-L1 dKI HuGEMM bearing hPD-L1 MC38 tumor, was used to further validate the therapeutic efficacy of ASC61.Methods: In the BALB/c mouse model, mice were inoculated subcutaneously with CT-26-hPD-L1 cells. When the average tumor volume reached approximately 69 mm3, mice were randomly assigned and treated twice a day (BID) with vehicle, reference drug (Atezolizumab), ASC61, GLC01-589 or GLC01-633 for 19 days. In the PD-1/PD-L1 dKI HuGEMM mouse model, MC38 hPD-L1 cells were subcutaneously inoculated in the right rear flank region of mice. Once the mean tumor size reached approximately 78.3 mm3, mice were randomized and treated BID for 16 days with vehicle, Atezolizumab, ASC61 (50 or 100 mg/kg). In both models, body weights and tumor volumes were measured regularly, and tumor growth inhibitions (TGI) of different groups were compared.Results: All mice showed a gradually increase in body weight during the study and no significant difference of body weight or body weight change was found among different groups in both mouse models. In the BALB/c mouse model, ASC61 50 mg/kg showed significantly inhibitory effects on the tumor growth with the best TGI value of 52.9% (p < 0.05) on Day 19, even better than that of the reference drug (40.77%). In the PD-1/PD-L1 dKI HuGEMM mouse model, Group 2 to 4 showed TGI values of 69.62%, 33.62% and 63.15% on Day 16, respectively. Atezolizumab 5 mg/kg BIW and ASC61 100 mg/kg BID produced similar significant antitumor efficacies (both p < 0.001). Survival analysis showed significant differences between Group 1 and Group 2 to 4 (p = 0.0002, 0.0338 and 0.0027, respectively).Conclusion: Results of this study show that ASC61 is well tolerated in both mouse models, and ASC61 has comparable antitumor efficacies as the FDA-approved PD-L1 antibody, Atezolizumab. ASC61 is an oral PD-L1 inhibitor, and thus will have better patient compliance than injective PD-1/PD-L1 antibody. ASC61 first in human clinical trial will begin soon.Citation Format: Jinzi J. Wu, Handan He. In vivo efficacy evaluation of ASC61, an oral PD-L1 inhibitor, in two tumor mouse models [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5529.

2022-06-15·Cancer Research

Abstract 5466: Efficacy of ASC60, an oral fatty acid synthase inhibitor, in two tumor mouse models

作者: He, Handan ; Wu, Jinzi J.

AbstractBackground: Fatty acid synthase (FASN) is a key enzyme controlling endogenous lipid biosynthesis and overexpressed in many cancers. Studies have shown that FASN inhibition can disrupt lipid synthesis in tumor cells and disrupt tumor-associated signal transduction, suggesting FASN inhibition can serve as a potential treatment for cancer. Here we report the in vivo efficacy data of ASC60, a small molecular FASN inhibitor, either as a single agent or in combination with mouse programmed cell death-1 (mPD-1) antibody in two tumor mouse models.Methods: In the MC38 mouse model, mice were inoculated subcutaneously with MC38 cells. When the average tumor volume reached approximately 62 mm3, mice were treated with ASC60 (60, and 100 mg/kg) or vehicle once a day (QD) for 3 weeks in combination mPD-1 antibody twice a week (1 mg/kg, BIW) for 2 weeks. In patient derived orthotopic xenograft (PDOX) brain metastasis mouse model, luciferase labelled breast cancer cells (LD1-2009-362541-Luc) were transplanted into the brain of nude mice. Tumor volumes were estimated by the luciferase reporter signal. When the average signal reached 4.12X107 photon/sec, mice were treated with ASC60 (20, 60, and 100 mg/kg) or vehicle QD for 4 weeks. In both mouse models, body weights and tumor volumes were measured regularly, and tumor growth inhibitions (TGI) of different groups were compared.Results: All animals showed a gradually increase in body weight during the study and no significant difference of body weight or body weight change was found among different groups. In the MC38 colon cancer mouse model, mice treated with ASC60 (60 or 100 mg/kg) in combination with mPD-1 antibody showed higher TGI values compared to those treated with mPD-1 alone (91.86%, 99.88% vs 89.84%) on Day 13, indicating combination with ASC60 would enhance the antitumor activity of mPD-1 antibody. In PDOX mouse model, mice treated with ASC60 (20, 60, and 100 mg/kg) showed dose dependent TGI values of 10.83%, 36.95% and 49.21% on Day 13 and of 6.46%, 21.27% and 30.47% on Day 27, respectively. ASC60 also showed a significant improvement in life span (51.5 days in ASC60 60 mg/kg vs 39 days in vehicle control).Conclusion: Previous in vitro testing showed that inhibition of palmitate synthesis by ASC60 was 137-fold lower in mouse than in human (IC50: 2.05 µM in mouse vs 0.015 µM in human). However, results of the present studies showed that ASC60 could suppress tumor growth and/or expand lifespan in the two tumor mouse models either alone or in combination with mPD-1 antibody. ASC60 will possibly demonstrate better efficacies in human.Citation Format: Jinzi J. Wu, Handan He. Efficacy of ASC60, an oral fatty acid synthase inhibitor, in two tumor mouse models [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5466.

项与 Ascletis BioScience Co., Ltd. 相关的新闻（医药）

2024-03-25

·BioSpace

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

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 Presented late-breaking poster at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2023 showcasing the beneficial shift in lipid pro denifanstat-treated patients End-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA) expected in first half of 2024; preparing to initiate pivotal Phase 3 trial evaluating denifanstat in patients with metabolic dysfunction-associated steatohepatitis (MASH) in the second half of 2024 Extended anticipated cash runway through 2025 by completing follow-on offering in January 2024 for $104.7 million in net proceeds; cash, cash equivalents and marketable securities totaled $94.9 million as of December 31, 2023 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 reported financial results for the full year ended December 31, 2023, and provided corporate updates. "2023 was an outstanding year for Sagimet, as we successfully transitioned to a public company and made significant progress in further clinically validating the therapeutic potential of denifanstat in patients living with MASH,” said David Happel, Chief Executive Officer of Sagimet. "Denifanstat’s novel mechanism of action targets the three key drivers of MASH, and we are pleased that the topline results from our Phase 2b FASCINATE-2 clinical trial met both primary efficacy endpoints and demonstrated a statistically significant reduction in fibrosis. We look forward to presenting the full data set at upcoming medical conferences later this year and expect to initiate a pivotal Phase 3 trial for denifanstat in MASH in the second half of 2024." Full Year and Recent Highlights In January 2024, Sagimet sold 9,000,000 shares of its Series A common stock in an underwritten public offering and received $104.7 million in net proceeds. Proceeds from the offering, together with its existing cash, cash equivalents and marketable securities will be used (i) to advance the development of denifanstat and begin startup activities related to the pivotal Phase 3 program in MASH, formerly known as nonalcoholic steatohepatitis (NASH), including manufacturing of additional drug supply, (ii) to advance the development of TVB-3567 and submit an investigational new drug application for a Phase 1 clinical trial for the treatment of acne and (iii) for other general corporate purposes, including additional clinical development, working capital and operating expenses. In January 2024, Sagimet announced positive topline results from the Phase 2b FASCINATE-2 clinical trial, evaluating denifanstat in biopsy-confirmed MASH patients with stage F2 or F3 fibrosis compared to placebo at week 52. The study met its primary efficacy endpoints: MASH resolution without worsening of fibrosis with ≥2-point reduction in NAS (NAFLD Activity Score) in 36% of denifanstat-treated patients vs 13% with placebo (p=0.0022) ≥2-point reduction in NAS without worsening of fibrosis in 52% of denifanstat-treated patients vs 20% with placebo (p=0.0001) Multiple secondary endpoints were met, achieving statistical significance, most notably fibrosis improvement by ≥ 1 stage with no worsening of MASH in 41% of denifanstat-treated patients vs 18% with placebo (p=0.005). In November 2023, Sagimet presented preclinical data evaluating denifanstat alone or in combination with semaglutide in mouse models of MASH at the 7th Obesity and NASH Drug Development Summit. The oral presentation highlighted that the FASN inhibitor, alone, was responsible for significant reduction of liver fibrosis. Additionally, the preclinical data suggested the combination of the FASN inhibitor and semaglutide has both an additive effect and provides support that distinct mechanism of actions may provide therapeutic benefit to patients with MASH. In October 2023, Sagimet’s license partner for China, Ascletis Bioscience Co. Ltd. (Ascletis), presented Phase 2 topline results at the European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin, Germany. The presentation demonstrated denifanstat’s significant efficacy in the change of total lesion and inflammatory lesion count from baseline and was well-tolerated in patients with acne. In July 2023, Sagimet closed an upsized IPO of Series A common stock, at a public offering price of $16.00 per share. Including shares issued pursuant to the exercise of the underwriters’ option, the Company issued 6,026,772 shares of Series A common stock, and received net proceeds of approximately $86.2 million. In January 2024, Ascletis announced the dosing of the first patient in its Phase 3 registration clinical trial of denifanstat for the treatment of moderate to severe acne. In January 2024, Ascletis announced the dosing of the first patient in its Phase 3 registration clinical trial of denifanstat combined with bevacizumab for treatment of recurrent glioblastoma; in September 2023, Ascletis announced enrollment of 120 patients in the trial, which it anticipates will provide sufficient events for its planned interim analysis of progression-free survival. Anticipated Upcoming Milestones The Phase 1 clinical trial results characterizing the pharmacokinetic and tolerability pro denifanstat in patients with impaired hepatic function are anticipated in the first quarter of 2024. Sagimet expects to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024, and plans to initiate the pivotal Phase 3 clinical trial of denifanstat in the second half of 2024. Sagimet has completed IND-enabling studies for TVB-3567, a FASN inhibitor, and are evaluating the timing to investigational new drug (IND) application for a Phase 1 clinical trial evaluating TVB-3567 in acne. Financial Results for the Year Ended December 31, 2023 Cash, cash equivalents and marketable securities for the year ended December 31, 2023 were $94.9 million, and together with the $104.7 million in net proceeds from the January 2024 public offering, are expected to fund operations for at least the next 12 months based on management’s current operating plan. Revenues for the year ended December 31, 2023 were $2.0 million compared to no revenues for fiscal 2022. The increase was due to a $2.0 million milestone payment that was recognized in July 2023. Research and development (R&D) expense for the year ended December 31, 2023 was $19.8 million compared to $24.9 million for the same period in 2022. The decrease in R&D expense was primarily driven by a decrease in activities related to our FASCINATE-2 clinical trial as we completed the trial in 2023 and reported positive top-line data in January 2024. General and administrative (G&A) expense for the year ended December 31, 2023 was $13.0 million compared to $6.1 million for the same period in 2022. The increase in G&A expense was primarily driven by expenses related to operating as a public company after completion of our IPO, including an increase in headcount and non-cash stock-based compensation. Net loss for the year ended December 31, 2023 was $27.9 million compared to a net loss of $30.5 million for the same period in 2022. About Sagimet Biosciences Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic 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 MASH. FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. For additional information about Sagimet, please visit . About MASH MASH is a progressive and severe liver disease which is estimated to impact more than 115 million people worldwide, for which there is only one recently approved treatment in the United States and no currently approved treatments in Europe. In 2023, global liver disease medical societies and patient groups formalized the decision to rename non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to metabolic dysfunction-associated steatohepatitis (MASH). Additionally, an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. The goal of the name change was to establish an affirmative, non-stigmatizing name and diagnosis. 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, including its FASCINATE-2 Phase 3 clinical trial; 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. Contact: Maria Yonkoski ICR Westwicke 203-682-7167 maria.yonkoski@westwicke.com SAGIMET BIOSCIENCES INC. STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except for share and per share amounts) (unaudited) Year Ended December 31, 2023 2022 Revenue: License revenue $ 2,000 $ — Total revenue 2,000 — Operating expenses: Research and development 19,777 24,919 General and administrative 12,963 6,136 Total operating expenses 32,740 31,055 Loss from operations (30,740 ) (31,055 ) Other income, net: Change in fair value of stock warrant liability 4 3 Interest income and other 2,860 553 Total other income, net 2,864 556 Net loss $ (27,876 ) $ (30,499 ) Other comprehensive gain (loss): Net unrealized gain (loss) on marketable securities 114 (84 ) Total other comprehensive gain (loss) 114 (84 ) Comprehensive loss $ (27,762 ) $ (30,583 ) Net loss per share attributable to common stockholders, basic and diluted $ (2.66 ) $ (165.20 ) Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted 10,460,335 184,619 SAGIMET BIOSCIENCES INC. BALANCE SHEETS (in thousands, except for share and per share amounts) (unaudited) As of December 31, 2023 2022 Cash, cash equivalents and marketable securities $ 94,897 $ 32,345 Total assets 96,719 33,031 Current liabilities 5,654 5,279 Noncurrent liabilities - 82 Redeemable convertible preferred stock - 214,620 Stockholders' equity (deficit) 91,065 (186,950 ) Total liabilities, redeemable preferred stock and stockholders' equity (deficit) $ 96,719 $ 33,031

临床2期临床结果临床3期临床1期财报

2023-11-13

·GlobeNewswire-Health Care

Sagimet Biosciences Reports Third Quarter 2023 Financial Results and Provides Corporate Updates

On track to report topline week 52 liver biopsy results from Phase 2b FASCINATE-2 trial with denifanstat in the first quarter of 2024 Two abstracts, including late-breaker, accepted at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023 Enrollment of 120 patients in Phase 3 registrational trial of denifanstat in recurrent glioblastoma (GBM) announced by license partner, Ascletis Presentation of positive topline Phase 2 denifanstat monotherapy data from Ascletis’ acne program SAN MATEO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic pathways, today reported financial results for the third quarter ended September 30, 2023, and provided recent corporate updates. “The data generated to date reinforce our belief that denifanstat has the potential to treat patient populations in need across important therapeutic indications including NASH, oncology, and acne. Denifanstat, as a once-daily, oral pill, offers a convenient and well-tolerated potential treatment, particularly important for NASH, for which there are currently no approved treatments in the United States or Europe,” said Dave Happel, Chief Executive Officer of Sagimet. “The Sagimet team remains focused on delivering week 52 topline results, including liver biopsy, from our Phase 2b FASCINATE-2 clinical trial in NASH in the first quarter of next year, a crucial milestone in our clinical development of denifanstat.” Recent Corporate Highlights Two abstracts were accepted at the AASLD – The Liver Meeting® 2023, held on November 10-14, in Boston, MA. An abstract detailing preclinical data from a mouse model of diet induced NASH highlighted that the combination of Sagimet’s FASN inhibitor and semaglutide reduced body weight and showed further histological improvement on liver pathology, including NAFLD activity score and fibrosis compared to single agent treatment.An interim analysis of FASCINATE-2, a Phase 2b randomized, placebo-controlled trial, demonstrated denifanstat’s reduction of circulating saturated diacylglycerols and triacylglycerols, markers of lipotoxicity. In October, Sagimet’s license partner for China, Ascletis Bioscience Co. Ltd. (Ascletis), presented Phase 2 topline results of denifanstat in patients with acne at the European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin, Germany showing that denifanstat demonstrated significant efficacy in the change of total lesion and inflammatory lesion count from baseline and was well-tolerated.In September, Ascletis announced enrollment of 120 patients in its Phase 3 registration clinical trial of denifanstat combined with bevacizumab for treatment of recurrent GBM, which it anticipates will provide sufficient events for its planned interim analysis of progression-free survival. Anticipated Upcoming Milestones The FASCINATE-2 Phase 2b clinical trial of denifanstat in liver biopsy-confirmed F2-F3 NASH patients is fully enrolled and week 52 topline results, including liver biopsy, are expected in the first quarter of 2024.Sagimet expects to report Phase 1 clinical trial results characterizing the pharmacokinetic and safety profile of denifanstat in patients with impaired hepatic function in the first quarter of 2024. Financial Results for the Three Months Ended September 30, 2023 Cash and cash equivalents for the third quarter ended September 30, 2023 were $101.8 million, expected to fund operations for at least the next 12 months based on management’s current operating plan. Revenues for the third quarter ended September 30, 2023 were $2.0 million compared to no revenues for the third quarter of 2022. For the nine months ended September 23, 2023, Revenues were $2.0 million compared to no revenues for the same period in the prior year. The increase was due to a $2.0 million milestone payment that was recognized in July 2023. Research and development (R&D) expense for the third quarter ended September 30, 2023 was $5.0 million compared to $6.8 million for the third quarter of 2022. For the nine months ended September 30, 2023, R&D expense was $14.1 million compared to $19.1 million for the same period in the prior year. The decrease in R&D expense was primarily driven by a decrease in activities related to our FASCINATE-2 clinical trial as patients progressed through the trial. General and administrative (G&A) expense for the third quarter ended September 30, 2023 was $4.5 million compared to $0.8 million for the same period in 2022. G&A expense for the nine months ended September 30, 2023 was $9.2 million compared to $4.6 million for the same period in the prior year. The increase in G&A expense was primarily driven by expenses related to operating as a public company after completion of its IPO, including an increase in headcount and non-cash stock-based compensation. Net loss for the third quarter ended September 30, 2023 was $6.4 million compared to a net loss of $7.5 million for the third quarter of 2022. The net loss for the nine months ended September 30, 2023 totaled $19.7 million compared to $23.3 million for the same period in 2022. About Sagimet Biosciences Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic 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 NASH, for which there are no treatments currently approved in the United States or Europe. Denifanstat is currently being tested in FASCINATE-2, a Phase 2b clinical trial in NASH with liver biopsy as the primary endpoint. For additional information about Sagimet, please visit www.sagimet.com. 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, including its FASCINATE-2 Phase 2b clinical trial; 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 www.sec.gov. 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. Contact: Maria YonkoskiICR Westwicke203-682-7167maria.yonkoski@westwicke.com SAGIMET BIOSCIENCES INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (in thousands, except for share and per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Revenue: License revenue $2,000 $- $2,000 $- Total revenue 2,000 - 2,000 - Operating expenses: Research and development $4,958 $6,838 $14,121 $19,072 General and administrative 4,494 848 9,153 4,595 Total operating expenses 9,452 7,686 23,274 23,667 Loss from operations (7,452) (7,686) (21,274) (23,667)Other income, net: Change in fair value of redeemable convertible preferred stock warrants - 1 (1) 3 Change in fair value of Series A common stock warrant 4 - 4 - Interest income and other 1,095 218 1,546 360 Total other income, net 1,099 219 1,549 363 Net loss $(6,353) $(7,467) $(19,725) $(23,304) Other comprehensive gain (loss): Net unrealized gain (loss) on investments in marketable securities - (56) 84 (162) Total other comprehensive gain (loss) - (56) 84 (162) Comprehensive loss $(6,353) $(7,523) $(19,641) $(23,466)Net loss per share attributable to common stockholders, basic and diluted $- $(40.34) $- $(126.13)Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted - 185,084 - 184,756 Net loss per share attributable to Series A and Series B common stockholders, basic and diluted $(0.35) $- $(3.22) $- Weighted-average shares outstanding used in computing net loss per share attributable to Series A and Series B common stockholders, basic and diluted 18,194,682 - 6,131,541 - SAGIMET BIOSCIENCES INC. CONDENSED BALANCE SHEETS (Unaudited) (in thousands, except for share and per share amounts) As of September 30, As of December 31, 2023 2022 Cash, cash equivalents and short-term investments $101,842 $32,345 Total assets 102,925 33,031 Current liabilities 5,049 5,279 Noncurrent liabilities 1 82 Redeemable convertible preferred stock - 214,620 Stockholders' equity (deficit) 97,875 (186,950) Total liabilities, redeemable preferred stock and stockholders' equity (deficit) $102,925 $33,031

临床2期临床结果财报临床1期临床3期

2023-08-21

·GlobeNewswire-Health Care

Sagimet Biosciences Reports Second Quarter 2023 Financial Results and Provides Corporate Updates

Completed upsized initial public offering raising $96.4 million in gross proceeds Presented positive data at EASL Congress 2023 from the planned interim readout of the Phase 2b FASCINATE-2 trial in NASH showing denifanstat was well-tolerated and met week 26 liver fat response endpoint On track to report topline week 52 liver biopsy results from Phase 2b FASCINATE-2 trial in the first quarter of 2024 Implemented leadership changes with Tony Rimac assuming the position of Chief Financial Officer and Liz Rozek joining as General Counsel & Chief Compliance Officer SAN MATEO, Calif., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, today reported financial results for the second quarter ended June 30, 2023, and provided recent corporate updates. “Sagimet has entered a new era as a public company, and I am proud of our team for the successful completion of our IPO and the continued advancement of denifanstat through clinical development in NASH,” said David Happel, Chief Executive Officer of Sagimet. “At EASL, we presented statistically significant results from the planned interim readout of the Phase 2b FASCINATE-2 trial of denifanstat in NASH, and we look forward to announcing the week 52 biopsy results in the first quarter of next year.” Recent Corporate Highlights On July 18, 2023, Sagimet closed an upsized IPO of Series A common stock, at a public offering price of $16.00 per share. Including shares issued pursuant to the exercise of the underwriters’ option, the Company issued 6,026,772 shares of Series A common stock, and received gross proceeds of approximately $96.4 million before deducting underwriting discounts and commissions and other offering expenses payable by Sagimet.In June, Sagimet presented planned interim data at the EASL Congress showing that denifanstat was well-tolerated and met the liver fat response endpoint in the Phase 2b FASCINATE-2 trial in biopsy confirmed F2-F3 NASH patients. 67% of treated patients achieved ≥30% reductions in liver fat at week 26 compared to 18% for placebo (p<0.001) as assessed by MRI-PDFF.In May 2023, Sagimet’s license partner for China, Ascletis Bioscience, announced Phase 2 topline results for denifanstat in acne vulgaris, reporting a statistically significant 61.3% reduction in total lesion count in patients treated with once daily, 50mg of denifanstat for 12 weeks, compared to a 34.2% reduction with placebo. Ascletis reported a statistically significant 65.0% reduction in inflammatory lesion count at 50mg denifanstat compared to a 31.4% reduction with placebo.In April, Sagimet appointed Tony Rimac as Chief Operating Officer and Liz Rozek as General Counsel & Chief Compliance Officer. In August, following the departure of Dennis Hom, Mr. Rimac was appointed as Chief Financial Officer. Anticipated Upcoming Milestones The FASCINATE-2 Phase 2b clinical trial for denifanstat in liver biopsy-confirmed F2-F3 NASH patients is fully enrolled with biopsy results expected in the first quarter of 2024.Sagimet expects to report Phase 1 clinical trial results that characterize the pharmacokinetic profile of denifanstat in patients with impaired hepatic function in the first quarter of 2024. Financial Results for the Three Months Ended June 30, 2023 Cash and cash equivalents for the second quarter ended June 30, 2023 were $18.5 million as of June 30, 2023. The subsequent IPO raised $86.2 million in net proceeds. Based on its operating plan, management expects the combined cash balance to fund operations into the first quarter of 2025. Research and development (R&D) expense for the second quarter ended June 30, 2023 was $4.7 million compared to $6.4 million for the second quarter of 2022. For the six months ended June 30, 2023, R&D expense was $9.2 million compared to $12.2 million for the same period in the prior year. The decrease for both periods was primarily due to a decrease in clinical trial costs for the FASCINATE-2 Phase 2b trial as patients progressed through the trial. General and administrative (G&A) expense for the second quarter ended June 30, 2023 was $2.4 million compared to $0.9 million for the same period in 2022. G&A expense for the six months ended June 30, 2023 was $4.7 million compared to $3.7 million for the same period in the prior year. The increase for both periods was primarily due to an increase in stock-based compensation expense and professional services related to Sagimet’s initial public offering.Net loss for the second quarter ended June 30, 2023 was $6.8 million compared to a net loss of $7.1 million for the second quarter of 2022. The net loss for the six months ended June 30, 2023 totaled $13.4 million compared to $15.8 million for the same period in 2022. About Sagimet Biosciences Sagimet is a clinical-stage biopharmaceutical company developing novel therapeutics called fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic 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 NASH, for which there are no treatments currently approved in the United States or Europe. Denifanstat is currently being tested in FASCINATE-2, a Phase 2b clinical trial in NASH with liver biopsy as the primary endpoint. For additional information about Sagimet, please visit www.sagimet.com. 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, including its FASCINATE-2 Phase 2b clinical trial; 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 www.sec.gov. 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. Contact: Robert UhlManaging Director, ICR Westwicke858.356.5932robert.uhl@westwicke.com SAGIMET BIOSCIENCES INC.CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited)(in thousands, except for share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Operating expenses: Research and development $4,676 $6,371 $9,163 $12,234 General and administrative 2,381 867 4,659 3,747 Total operating expenses 7,057 7,238 13,822 15,981 Loss from operations (7,057) (7,238) (13,822) (15,981)Other income (expense), net: Change in fair value of redeemable convertible preferred stock warrants 1 - (1) 2 Interest income and other 271 136 451 142 Total other income, net 272 136 450 144 Net loss $(6,785) $(7,102) $(13,372) $(15,837) Comprehensive loss $(6,772) $(7,208) $(13,288) $(15,943)Net loss per share attributable to common stockholders, basic and diluted $(35.80) $(38.37) $(71.39) $(85.80)Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted 189,520 185,084 187,314 184,589 SAGIMET BIOSCIENCES INC. CONDENSED BALANCE SHEETS(Unaudited)(in thousands, except for share and per share amounts) As of June 30, As of December 31, 2023 2022 Cash, cash equivalents and short-term investments $18,508 $32,345 Total assets 21,498 33,031 Current liabilities 5,287 5,279 Noncurrent liabilities 5 82 Redeemable convertible preferred stock 214,620 214,620 Stockholders' deficit (198,414) (186,950) Total liabilities, redeemable preferred stock and stockholders' deficit $21,498 $33,031

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