Sagimet Biosciences Inc.

Previous wording

In January 2024, we announced that denifanstat had met both primary endpoints and multiple secondary endpoints in the Phase 2b FASCINATE-2 clinical trial evaluating denifanstat in 168 biopsy-confirmed MASH patients with stage F2 or F3 fibrosis compared to placebo at week 52. The trial results were published in October 2024 inThe Lancet Gastroenterology & Hepatology.

Current wording

Denifanstat met all primary and multiple secondary endpoints in the Phase 2b FASCINATE-2 clinical trial evaluating denifanstat in 168 biopsy-confirmed MASH patients with stage F2 or F3 fibrosis compared to placebo at week 52. We announced topline results in January 2024 and published the trial results inThe Lancet Gastroenterology & Hepatology in October 2024. Denifanstat also demonstrated anti-fibrotic activity, including in patients with advanced fibrosis, as seen in the F3 modified intention to treat (mITT) population and qF4 patients (qF4 patients are AI-defined F4, based on the second harmonic generation (SGH) HistoIndex platform, which may encompass late stage F3 as well as F4 patients):

Previous wording

In the second half of 2025, subject to consultation with regulatory authorities, we plan to initiate a Phase 1 clinical trial to evaluate the pharmacokinetics (PK) and tolerability of a combination of denifanstat and resmetirom with an anticipated data readout in the first half of 2026. We presented preclinical data at EASL in 2024 for two mouse models of MASH, showing that the combination of a FASN inhibitor (TVB-3664, a surrogate for denifanstat) and the thyroid hormone receptor beta (THRb) agonist, resmetirom (Rezdiffra™), had a synergistic effect on important liver disease markers, including improvement of NAS by histologic analysis and more robust improvement in hepatic collagen content compared to the single agents. Synergistic activity of the combination was demonstrated in the rate of histological improvement (NAS ≥2 points), which was 33% for FASN inhibitor monotherapy, 25% for resmetirom monotherapy, and 80% for the combination of the two, a level of improvement that greatly exceeds a simple addition of the activity of the two drugs. Given that resmetirom is currently the only product approved for treatment of MASH, the planned Phase 1 clinical PK trial would allow

Current wording

Our combination program builds upon preclinical data we presented at the European Association for the Study of the Liver (EASL) Congress in 2024 for two mouse models of MASH, showing that the combination of a FASN inhibitor (TVB-3664, a surrogate for denifanstat) and resmetirom, had a synergistic effect on important liver disease markers, including improvement of NAS by histologic analysis and more robust improvement in hepatic collagen content compared to the single agents. Synergistic activity of the combination was demonstrated in the rate of histological improvement (NAS ≥2 points), which was 33% for FASN inhibitor monotherapy, 25% for resmetirom monotherapy, and 80% for the combination of the two, a level of improvement that greatly exceeds a simple addition of the activity of the two drugs.

Previous wording

In addition to MASH, we are exploring our FASN inhibitors inacne, in which dysregulation of fatty acid metabolism also plays a key role. In a press release on June 3, 2025, our license partner, Ascletis BioScience Co. Ltd. (Ascletis), a subsidiary of Ascletis Pharma Inc. (Ascletis Pharma)announced that denifanstat met all primary and secondary endpoints in its Phase 3 trial in moderate to severe acne vulgaris, in China. The Phase 3 clinical trial 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 to receive denifanstat 50mg or placebo, once daily for 12 weeks.

Current wording

In June 2025, our license partner for China, Ascletis BioScience Co. Ltd. (Ascletis), a subsidiary of Ascletis Pharma Inc. (Ascletis Pharma)announced that denifanstat met all primary and secondary endpoints in its Phase 3 trial in moderate to severe acne vulgaris in China. The Phase 3 clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial of 480 enrolled patients randomized 1:1 to receive denifanstat 50mg or placebo, once daily for 12 weeks.

Previous wording

In its June 3, 2025 press release, Ascletis reported the following efficacy data from the Phase 3 trial of denifanstat in moderate to severe acne vulgaris:

Current wording

Ascletis reported the following efficacy data from the Phase 3 trial:

Previous wording

In its June 3, 2025 press release, 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%.

Current wording

Ascletis reported that denifanstat was generally well-tolerated. Following 12 weeks of once-daily oral administration at 50 mg, the incidence rates of TEAEs were comparable between denifanstat and placebo.

Previous wording

Ascletis indicated in its June 3, 2025 press release that it plans to submit denifanstat for approval to the China National Medical Products Administration for the treatment of moderate to severe acne.

Current wording

In October 2025, Ascletis announced that ithad completed its pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) for denifanstat for the treatment of moderate to severe acne vulgaris and plans to submit an NDA soon to the NMPA.

Previous wording

In March 2025, we announced the clearance of our Investigational New Drug (IND) application for a first-in-human Phase 1 clinical trial of our second FASN inhibitor, TVB-3567. TVB-3567 is a potent and selective small molecule FASN inhibitor, planned to enter clinical development for the treatment of acne. In June 2025, we initiated a first-in-human Phase 1 clinical trial of TVB-3567 for development of an acne indication. The Phase 1 clinical trial is a randomized double-blind placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TVB-3567 in healthy participants with or without acne. The trial is comprised of several parts, including single ascending dose cohorts and multiple ascending dose cohorts in participants without acne, followed by testing in participants with acne including evaluation of pharmacodynamic biomarkers.

Current wording

In June 2025, we initiated a first-in-human Phase 1 clinical trial of our potent and selective small molecule FASN inhibitor, TVB-3567, for development of an acne indication. The Phase 1 clinical trial is a randomized double-blind placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TVB-3567 in healthy participants with or without acne. The trial is comprised of several parts, including single ascending dose cohorts and multiple ascending dose cohorts in participants without acne, followed by testing in participants with acne including evaluation of pharmacodynamic biomarkers. Subject to consultation with regulatory authorities, and contingent on the results of the Phase 1 trial, we anticipate initiating the Phase 2 trial of TVB-3567 in 2026.

Previous wording

Research and development expenses represent costs incurred in performing research, development and manufacturing activities in support of our own product development efforts and include internal personnel-related costs (such as salaries, employee benefits and stock-based compensation) for our personnel in research and development functions; as well as external costs, including costs related to acquiring, developing and manufacturing supplies for preclinical studies, clinical trials and other studies, including fees paid to contract manufacturing organizations (CMOs); costs and expenses related to agreements with contract research organizations (CROs), investigative sites and consultants to conduct non-clinical and preclinical studies and clinical trials; professional and consulting services costs; and facility and other allocated costs.

Current wording

Research and development expenses represent costs incurred in performing research, development and manufacturing activities in support of our own product development efforts and include internal personnel-related costs (such as salaries, employee benefits and stock-based compensation) for our personnel in research and development functions; as well as external costs, including costs related to acquiring, developing and manufacturing supplies for preclinical studies, clinical trials and other studies, including fees paid to contract manufacturing organizations (CMOs); costs and expenses related to agreements with contract research organizations (CROs), investigative sites and consultants to conduct non-clinical and preclinical studies and clinical trials; professional and consulting services costs; and facility and other allocated costs. Research and development expenses also include the costs of acquired product licenses and related technology rights where there is no alternative future use.

Previous wording

*General and administrative –*General and administrative expenses increased by $1.4 million, or 18%, for the six months ended June 30, 2025, compared to the six months ended June 30, 2024 primarily due to (i) a $1.1 million increase in personnel costs, inclusive

Current wording

*General and administrative –*General and administrative expenses increased by $0.4 million, or 8%, for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 primarily due to a $0.4 million increase in consulting and professional fees, driven by legal fees and the write-off of deferred financing costs.

Previous wording

*Other income –*Other income decreased by $0.9 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024, due to a decrease in interest income earned driven by a lower cash, cash equivalents and marketable securities balance during the three months ended June 30, 2025.

Current wording

*Other income –*Other income decreased by $0.9 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024, due to a decrease in interest income earned driven by a lower cash, cash equivalents and marketable securities balance as well as lower yields during the three months ended September 30, 2025.

Previous wording

Research and development – Research and development expenses for the six months ended June 30, 2025 and 2024 were comprised of the following (in thousands):

Current wording

Research and development – Research and development expenses for the nine months ended September 30, 2025 and 2024 were comprised of the following (in thousands):

Previous wording

Research and development expenses increased by $0.9 million, or 15%, for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. This increase was primarily due to (i) a $1.0 million increase in clinical development and research expenses related primarily to clinical trial costs incurred for our Phase 3 program of denifanstat in MASH, as well as costs incurred for thefirst-in-human Phase 1 clinical trial of TVB-3567, which was initiated in June 2025, and (ii) a $0.2 million increase in personnel costs due to an increase in headcount. These increases were partially offset by a $0.2 million decrease in other internal operating expenses.

Current wording

Research and development expenses increased by $8.1 million, or 33%, for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024. This increase was primarily due to (i) a $5.3 million increase in clinical development and research expenses related primarily to clinical trial costs incurred for our Phase 3 program of denifanstat in MASH, as well as costs incurred for the Phase 1 clinical trial of TVB-3567, which was initiated in June 2025, and the Phase 1 PK clinical trial for the combination

Previous wording

Research and development expenses increased by $11.0 million, or 95%, for the six months ended June 30, 2025, compared to the six months ended June 30, 2024. This increase was primarily due to (i) a $10.7 million increase in clinical development and research expenses related primarily to clinical trial costs incurred for our Phase 3 program of denifanstat in MASH, as well as costs incurred for thefirst-in-human Phase 1 clinical trial of TVB-3567, which was initiated in June 2025, partially offset by lower clinical trial expenses for the Phase 2b FASCINATE-2 trial as the trial was substantially complete in the first quarter of 2024 and topline results for the trial were announced in January 2024, and (ii) a $0.5 million increase in personnel costs due to an increase in headcount. These increases were partially offset by a $0.5 million decrease in other internal operating expenses.

Current wording

of denifanstat and resmetirom, which was initiated in September 2025, partially offset by lower clinical trial expenses for the Phase 2b FASCINATE-2 trial as the trial was substantially complete in the first quarter of 2024 and topline results for the trial were announced in January 2024, (ii) an increase in manufacturing and non-clinical expenses of $2.2 million relating primarily to the $2.5 million up-front license fee recognized in connection with entering into the CMO Term Sheet in September 2025, and (iii) a $0.7 million increase in personnel costs due to an increase in headcount.

Previous wording

*General and administrative –*General and administrative expenses increased by $0.4 million, or 9%, for the three months ended June 30, 2025, compared to the three months ended June 30, 2024 primarily due to (i) a $0.3 million increase in personnel costs, inclusive of a $0.2 million increase in stock-based compensation driven by an increase in headcount, and (ii) a $0.1 million increase in consulting and professional fees, driven by legal fees.

Current wording

*General and administrative –*General and administrative expenses increased by $1.8 million, or 15%, for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024 primarily due to (i) a $1.1 million increase in stock-based compensation driven by an increase in headcount, and (ii) a $0.8 million increase in consulting and professional fees, driven by legal fees and the write-off of deferred financing costs.

Previous wording

*Other income –*Other income decreased by $1.4 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024, due to a decrease in interest income earned driven by a lower cash, cash equivalents and marketable securities balance during the six months ended June 30, 2025.

Current wording

*Other income –*Other income decreased by $2.2 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, due to a decrease in interest income earned driven by a lower cash, cash equivalents and marketable securities balance as well as lower yields during the nine months ended September 30, 2025.

Previous wording

In August 2024, we entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. (Cantor) to establish an at-the-market offering (ATM Offering) through which we may offer and sell, from time to time at our sole discretion, up to $75.0 million of shares of our Series A common stock through Cantor acting as our sales agent. There were no sales under the ATM Offering during the three and six months ended June 30, 2025.

Current wording

In August 2025, we entered into a Sales Agreement with Leerink Partners LLC to establish an at-the-market offering (2025 ATM Offering) through which we may sell, from time to time at our sole discretion, up to $75.0 million shares of our Series A common stock. There were no sales under the 2025 ATM Offering during the three months ended September 30, 2025.

Previous wording

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $135.5 million. We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our drug candidates, which we expect will take a number of years, if ever. We anticipate that we will continue to incur significant expenses for the foreseeable future as we continue to advance our drug candidates through preclinical and clinical trials; manufacture supplies for our preclinical studies and clinical trials; expand our corporate infrastructure, including the costs associated with being a public company; pursue regulatory approval of our drug candidates; hire additional personnel; acquire, discover, validate and develop additional drug candidates; and obtain, maintain, expand and protect our intellectual property portfolio.

Current wording

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $125.5 million. We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our drug candidates, which we expect will take a number of years, if ever. We anticipate that we will continue to incur significant expenses for the foreseeable future as we continue to advance our drug candidates through preclinical and clinical trials;

Previous wording

*Cash flows from operating activities.*Net cash used in operating activities was $23.6 million for the six months ended June 30, 2025, and primarily related to cash used to fund clinical development, manufacturing and other non-clinical activities for denifanstat, inclusive of clinical-batch manufacturing and other trial costs for our Phase 3 program of denifanstat in MASH, clinical development and manufacturing costs for TVB-3567, as well as costs associated with operating as a public company.

Current wording

*Cash flows from operating activities.*Net cash used in operating activities was $33.8 million for the nine months ended September 30, 2025, and primarily related to cash used to fund clinical development, manufacturing and other non-clinical activities for denifanstat, inclusive of trial costs for our Phase 3 program of denifanstat in MASH as well as the Phase 1 PK clinical trial for the combination of denifanstat and resmetirom, clinical development and manufacturing costs for TVB-3567, as well as costs associated with operating as a public company.

Previous wording

Net cash used in operating activities was $11.8 million for the six months ended June 30, 2024, and primarily related to cash used to fund clinical development, manufacturing and other non-clinical activities for denifanstat, inclusive of clinical-batch manufacturing and other trial start-up costs for our Phase 3 program of denifanstat in MASH, as well as costs to build out our corporate infrastructure and costs associated with being a public company.

Current wording

Net cash used in operating activities was $31.4 million for the nine months ended September 30, 2024, and primarily related to cash used to fund clinical development, manufacturing and other non-clinical activities for denifanstat, inclusive of clinical-batch manufacturing and other trial start-up costs for our Phase 3 program of denifanstat in MASH, as well as costs to build out our corporate infrastructure and costs associated with being a public company.

Previous wording

*Cash flows from investing activities -*Net cash used in investing activities was $9.9 million for the six months ended June 30, 2025 and related to purchases of marketable securities of $58.5 million, partially offset by proceeds received from the sale and maturity of marketable securities of $48.6 million.

Current wording

*Cash flows from investing activities -*Net cash used in investing activities was $9.8 million for the nine months ended September 30, 2025 and related to purchases of marketable securities of $89.8 million, partially offset by proceeds received from the sale and maturity of marketable securities of $80.0 million.

Previous wording

Net cash used in investing activities was $72.2 million for the six months ended June 30, 2024 and related to purchases of marketable securities of $83.0 million, partially offset by proceeds received from the sale and maturity of marketable securities of $10.8 million.

Current wording

Net cash used in investing activities was $71.5 million for the nine months ended September 30, 2024 and related to purchases of marketable securities of $94.3 million, partially offset by proceeds received from the sale and maturity of marketable securities of $22.8 million.

Previous wording

Cash flows from financing activities– Net cash provided by financing activities was approximately $1,000 for the six months ended June 30, 2025, relating to proceeds from stock option exercises during the period.

Current wording

Cash flows from financing activities– Net cash provided by financing activities was approximately $0.3 million for the nine months ended September 30, 2025, relating to proceeds from stock option exercises during the period.

Previous wording

Net cash provided by financing activities was $104.8 million for the six months ended June 30, 2024, which primarily related to net cash proceeds of $105.7 million received from the sale of Series A common stock in our January 2024 follow-on offering and $0.1 million in proceeds from stock option exercises during the period, offset by the payment of financing costs related to the January 2024 follow-on offering of $1.0 million.

Current wording

Net cash provided by financing activities was $104.8 million for the nine months ended September 30, 2024, which primarily related to net cash proceeds of $105.7 million received from the sale of Series A common stock in our January 2024 follow-on offering and $0.1 million in proceeds from stock option exercises during the period, offset by the payment of financing costs related to the January 2024 follow-on offering of $1.0 million.

Previous wording

During the six months ended June 30, 2025, there were no material changes to our critical accounting estimates or in the methodology used for estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024.

Current wording

During the nine months ended September 30, 2025, there were no material changes to our critical accounting estimates or in the methodology used for estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024.