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Form 8-K

sec.gov

8-K — Sagimet Biosciences Inc.

Accession: 0001104659-26-049015

Filed: 2026-04-27

Period: 2026-04-27

CIK: 0001400118

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — tm2612794d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2612794d1_ex99-1.htm)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

April 27, 2026

SAGIMET BIOSCIENCES INC.

(Exact name of registrant as specified in its

charter)

Delaware

001-41742

20-5991472

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

Sagimet Biosciences Inc.

155 Bovet Road, Suite 303,

San Mateo, California 94402

(Address of principal executive offices, including

zip code)

(650) 561-8600

(Registrant’s telephone number, including

area code)

Not Applicable

(Former Name or Former Address, if Changed Since

Last Report)

Check the appropriate box below if the Form 8-K filing is intended

to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨

Written communications pursuant

to Rule 425 under the Securities Act (17 CFR 230.425)

¨

Soliciting material pursuant

to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨

Pre-commencement communications

pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨

Pre-commencement communications

pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trade

Symbol(s)

Name of each exchange on which registered

Series A Common Stock, $0.0001 par value per share

SGMT

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth

company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities

Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging

growth company x

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 7.01

Regulation FD Disclosure.

On April 27, 2026, Sagimet

Biosciences Inc. (the “Company”) updated information reflected in a slide presentation, which is attached as Exhibit 99.1

to this Current Report on Form 8-K and is incorporated herein by reference. Representatives of the Company will use the updated presentation

in various meetings with investors from time to time.

The information in Item 7.01 of this Current

Report on Form 8-K, including the information set forth in Exhibit 99.1, is being furnished and shall not be deemed “filed”

for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall Exhibit 99.1

furnished herewith be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act,

except as shall be expressly set forth by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits

(d) Exhibits

Exhibit

No.

Document

99.1

Investor Presentation of Sagimet Biosciences Inc., dated April 27, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934,

as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Sagimet

Biosciences Inc.

Date:

April 27, 2026

By:

/s/

David Happel

David

Happel

Chief

Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2612794d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Targeting MetabolicDysfunction

with Novel Therapeutics

April 2026

April 2026 2

Forward-Looking Statements and Disclaimer

This presentation contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation

Reform Act of 1995. All statements contained in this document, other than statements of historical facts or statements that relate to present facts or current

conditions, including but not limited to, statements regarding possible or assumed future results of operations, business strategies, research and development

plans, regulatory activities, the presentation of data from clinical trials, Sagimet’s clinical development plans and related timelines and anticipated clinical

development milestones, market opportunity, competitive position and potential growth opportunities are forward-looking statements. These statements involve

known and unknown risks, uncertainties and other important factors that may cause our 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, you can identify forward-looking

statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,”

“potential,” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this presentation are only predictions.

These forward-looking statements speak only as of the date of this presentation 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 our control, including, among others: the clinical development and therapeutic potential

of denifanstat, TVB-3567 or any other drug candidates or combination therapies developed by Sagimet; our ability to advance drug candidates into and

successfully complete clinical trials, the risk the topline clinical trials may not be predictive of, and may differ from final clinical data and later-stage clinical trials;

our ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; that unfavorable new clinical trial data may

emerge in other clinical trials of our product candidates; that clinical trial data are subject to differing interpretations and assessments, including by regulatory

authorities; our relationship with Ascletis, and the success of its development efforts for denifanstat; the accuracy of our estimates regarding our capital

requirements; and our 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 our most recent filings with the Securities and ExchangeCommission (SEC) 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 our forward-looking statements

may not be achieved or occur,and actual results could differ materially from those projectedin the forward-lookingstatements.

Moreover, we operate 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 we may face. Except as required by applicable law, we do not plan to publicly update or revise any

forward-lookingstatements contained herein,whether as a result of any new information,future events,changedcircumstances or otherwise.

April 2026 3

DaveHappel President&CEO

>20 years of experience in executive leadership in biotech

and pharma

Brought multiple innovative healthcare products to the market

Andreas Grauer Chief Medical Officer

> 20 years of experience in Clinical Development and Medical

Affairs across a broad range of therapeutic areas

Deep experience in regulatory interactions around the world

resulting in multiple BLA and NDA approvals

Thierry ChaucheChief Financial Officer

>20 years of financial and operational leadership experience in

finance and healthcare companies

Elizabeth Rozek Chief Legal & Administrative Officer

>20 years of legal experience including executive leadership

of legal, IP and compliance functions in biopharma and biotech

Rob D’Urso Senior Vice President, New Products

>20 years of US and global leadership experience in

dermatology

Marie O'Farrell Chief Scientific Officer

>20 years of experience in R&D and translational medicine in

biopharma and biotech

Successfully guided development for multiple clinical programs

Leadership Team with Proven Development and Commercialization Experience

April 2026 4

TVB-3567 in Acne

Unique MOA: FASN Inhibition

Sagimet at a Glance: Differentiated Dermatology Assets with Clinical Validation

• Our lead molecule, denifanstat, is a novel fatty acid synthase (FASN) inhibitor with a differentiated

method of action with the potential to target multiple underserved diseases

• Strong clinical data demonstrates denifanstat’s proof of concept across multiple disease states

• Denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial in patients with moderate to

severe acne vulgaris conducted by Ascletis, our license partner for Greater China

• Denifanstat was generally well-tolerated in Ascletis’ Phase 3 study and open-label extension study

• Ascletis announced that denifanstat NDA for the treatment of moderate to severe acne was accepted by the

China NMPA in December 2025

• We plan to advance denifanstat into a Phase 3 clinical trial in moderate to severe acne patients for the US in

2H 2026, contingent on consultation with regulatory authorities

• Our follow-on FASN inhibitor, TVB 3567, received Investigational New Drug (IND) clearance in March 2025

• First-in-human (FIH) Phase 1 clinical trial initiated in June 2025 for development of an acne indication

• Phase 1 clinical trial results anticipated in 2026, Phase 2 proof of concept clinical trial anticipated to begin

in 2H 2026, subject to regulatory feedback

Denifanstat in Acne

April 2026 5

Denifanstat in Other

Indications

Strong IP, Cash Position, and Collaboration Potential

• Successful outcome of Phase 2b clinical trial in MASH (metabolic dysfunction-associated steatohepatitis);

met both primary endpoints with significant reduction in fibrosis

• Pre-clinical data demonstrated synergistic effect of combination of FASN inhibitor and resmetirom

• Phase 1 pharmacokinetics (PK) clinical trial of a combination of denifanstat and resmetirom completed in

December 2025

• Further MASH development to be undertaken only upon securing non-dilutive funding

• Denifanstat:

• Composition of matter patent expected to expire in 2032; potential PTE to 2037

• TVB-3567:

• Composition of matter patent expected to expire in 2035; potential PTE to 2038

• Method of use application for TVB-3567 for acne filed 2025; if granted expected to expire in 2046

• Combination of denifanstat and resmetirom:

• Application filed 2024; if granted expected to expire in 2044; potential PTE to 2048

• $113.1M cash on hand as of 12/31/2025 and $104.5M as of 3/31/2026 *

• Announced $175M underwritten offering of Series A Common Stock in April 2026. Use of proceeds,

together with existing cash, cash equivalents and marketable securities is expected to fund current

operations through 2028, and through readout of denifanstat Phase 3 trial in moderate to severe acne

*Cash, cash equivalents and marketable securities; 3/31/2026 cash on hand unaudited, preliminary and subject to change

IP Portfolio

Cash Position

April 2026 6

Therapeutic

Area Indication Stage of Development Milestone / Program Updates

Preclinical Phase 1 Phase 2 Phase 3

Dermatology Acne

Phase 3 clinical trial for the US expected to initiate in

2H 2026

Phase 1 FIH clinical trial initiated in June 2025

Topical formulation in development

Met all primary and secondary endpoints in Phase 3

clinical trial & NDA accepted by NMPA in December

2025*

Metabolic

Disease MASH

Phase 2b clinical trial met histology primary and

multiple secondary endpoints; FDA Breakthrough

Therapy designation; Phase 3 ready (F2/F3 MASH)

Phase 1 clinical trial hepatic impairment results

reported 1Q2024

Phase 1 clinical PK trial completed in December 2025

Oncology Solid tumors Identifying FASN-dependent tumor types for

potential FASN inhibitor development

Development Pipeline: Multiple Indications and Clinical Milestones

* Clinical trial conducted in China by Ascletis, who has licensed development and commercialization rights to all indications in Greater China.

Denifanstat

Denifanstat

TVB-3567

Denifanstat (ASC40)

TVB-3567

Denifanstat

Denifanstat/resmetirom

Denifanstat

FASN

inhibitor

FASN Inhibition Offers

Differentiated MOA in Acne

April 2026 8

4 key drivers of acne1:

• Increased sebum in sebaceous glands (80% of lipids produced through DNL)2

• Abnormal or excessive follicular hyper-keratinization

• Accelerated bacterial growth (C. acnes)

• Localized inflammatory response

Potential Role of FASN Inhibitors in the Pathogenesis of Acne

1. Vasam M, et al., Biochem Biophys Rep. 2023;36:101578. https://pmc.ncbi.nlm.nih.gov/articles/PMC10709101/#abs0010

2. Esler, et al., Sci. Transl. Med. 2019; 11:492.

3. A) Duke G, et al., Presented at: AASLD 2016; November 11-15, 2016; Boston, MA. https://sagimet.com/wp-content/uploads/2016/11/2016_AASLD_FASN_NASH_36x60_v10.pdf.

And B) Syed-Abdul MM et al., Hepatology. 2020;72(1):103.

4. O’Farrell M, et al. Sci Rep. 2022;12(1):15661.

FASN

Palmitate / sapienic acid

Lipid synthesis

Sebum production

Hair Skin Surface

Sebum

(oil)

Inflammation

Sebaceous

gland

Skin Without Acne Skin With Acne

Pimple

Sebaceous

gland

FASN inhibition MOA shows potential to treat acne:

• Denifanstat directly reduced cutaneous (skin) sebum DNL lipids in two

Phase 1 clinical trials3

• FASN inhibition has potential to reduce inflammation, through decreasing

cytokine secretion and Th17 activation4

April 2026 9

Blackheads Whiteheads Papules & Pustules Cysts & Nodules

Acne Market Overview

Global acne market is expected to reach $20B by 20341

50 million people suffer with acne in the US annually2

• Acne is one of the most common skin conditions in the United States, with approximately 50 million Americans affected annually and more

than 5 million seeking medical treatment for acne each year2

• Acne affects approximately 85% of persons between the ages of 12 and 243

• There is no cure for acne; and due to its pathology, most patients require chronic management and multiple annual courses of treatment for

flare control

10 million people suffer from moderate to severe acne in the US annually

• Moderate to severe acne accounts for 20% of acne sufferers, or approximately 10 million people in the US annually4

1. Acne Medication Market Size to Surpass USD 19.95 Billion by 2034 Driven by Rising Acne Prevalence, Skincare Awareness, and Innovative Treatments, Precedence Research, Sep 2025; https://finance.yahoo.com/news/acne-medication-market-size-surpass-114200888.html

2. Bickers DR, et al. J Am Acad Dermatol. 2006;55(3):490-500. 3. Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. Mar 2013;168(3):474-85. doi:10.1111/bjd.12149

4. Szepietowska M, et al., Prevalence, Intensity and Psychosocial Burden of Acne Itch: Two Different Cohorts Study. J Clin Med. 2023 Jun 12;12(12):3997. doi: 10.3390/jcm12123997. PMID: 37373690; PMCID: PMC10299123.

April 2026 10

Mild Disease Moderate to Severe Disease

Acne Treatment Algorithm

Disease management involves flare and prevention intervention

Treatment includes topical

agents used as mono or

combination therapy

Main topical therapies:

• Retinoids

• Benzoyl Peroxide

• Antibiotics

• Clascoterone

• Salicylic Acid

• Azelaic Acid

Treatment approach adds oral

products on top of topical agents

Main oral therapies:

• Antibiotics (tetracyclines, sarecycline)

• Hormonal contraceptives

• Spironolactone (off-label)

• Intralesional corticosteroids

Severe (cystic) patients are

generally managed with

isotretinoin (Accutane)

Main therapy:

• Isotretinoin

Severe (Cystic) Disease

Oral FASN Inhibitor

Topical FASN Inhibitor

Potential treatment positioning for FASN inhibitors

Source: https://www.jaad.org/article/S0190-9622(23)03389-3/fulltext

Routine

Management

Main approaches:

• OTC cleansers

• Moisturizers

• Sunscreens

Skin care routines to

address treatment-related AEs

Denifanstat’s Clinical Data

in Acne

April 2026 12

Pharmacodynamic Data Support Mechanism of Action of Denifanstat in Acne

• Demonstrated a >90% reduction in sebum lipids by

day 151,2

• Maintained the reduced level of sebum lipids

through the entire study1,2

• Demonstrated a dose responsive impact on sebum

lipids1,2

Note: denifanstat dose in this Phase 1 clinical trial in cancer patients

is several times higher than 50 mg dose tested in acne and MASH

In multiple Phase 1 clinical trials, denifanstat

demonstrated a decrease in DNL sebum lipids1-3

1. Duke G, et al. Presented at: EASL 2017; April 19-23, 2017; Amsterdam, The Netherlands. https://sagimet.com/wp-content/uploads/2017/05/3VBIO_EASLposter.pdf.

2. Falchook G, et al. EClinicalMedicine. 2021;34:100797.

3. Duke G, et al. Presented at: AASLD 2016; November 11-15, 2016; Boston, MA. https://sagimet.com/wp-content/uploads/2016/11/2016_AASLD_FASN_NASH_36x60_v10.pdf.

Days on therapy (# of subjects)

Phase 1 oncology clinical trial

Sebutape® assessment of cutaneous sebum lipids1,2

April 2026 13

Ascletis Acne Phase 3 Clinical Trial Design

• Moderate to severe acne

• Multi-center placebo controlled

• 1:1 randomization

• Double-blind

• Once daily oral dosing

• 480 patients in China

Co-primary endpoints at week 12

• % patients who achieve IGA success (defined as at least a 2-point reduction in IGA from baseline, and an IGA of 0 or 1 at week 12)

• % change in total skin lesion counts from baseline

• % change in inflammatory skin lesion counts from baseline

Key secondary endpoint at week 12

• % change in non-inflammatory skin lesion counts from baseline

Screening

Placebo

N=240

Denifanstat (50mg)

N=240

Day 1 Week 12

Primary

Efficacy

Denifanstat(50mg)

N=240

Long-Term

Safety

Ph3

Double blind clinical trial1

Ph3

Open label safety trial2

Week 12 Week 52

Denifanstat Phase 3 in acne

1. ClinicalTrials.gov. NCT06192264. Study ASC40-303. https://clinicaltrials.gov/study/NCT06192264. 2. ClinicalTrials.gov. NCT06248008. Study ASC40-304. https://clinicaltrials.gov/study/NCT06248008.

April 2026 14

Ascletis Acne Phase 3 Clinical Trial Met All Primary and Secondary Endpoints

Baseline Characteristics 50mg denifanstat

(n=240)

Placebo

(n=240)

Total lesion count 102.2 102.1

Inflammatory lesion count 42.1 43.1

IGA=3 (moderate), % 85.8 85.8

IGA=4 (severe), % 14.2 14.2

Efficacy endpoints 1 50mg denifanstat

(n=240)

Placebo

(n=240)

50mg denifanstat

(placebo adjusted) p value

% Treatment success (IGA) 2 (primary endpoint) 33.2 14.6 18.6 <0.0001

% Change in total lesion count (primary endpoint) -57.4 -35.4 -22.0 <0.0001

% Change in inflammatory lesion count (primary endpoint) -63.5 -43.2 -20.3 <0.0001

% Change in non-inflammatory lesion count (key secondary endpoint) -51.9 -28.9 -23.0 <0.0001

Absolute change in total lesion count (secondary endpoint) -58.3 -36.2 -22.1 <0.0001

Absolute change in inflammatory lesion count (secondary endpoint) -26.6 -18.4 -8.2 <0.0001

Ascletis data on file. Baseline demographics and efficacy endpoints of 50 mg denifanstat oral, once daily for 12 weeks versus Placebo (Intent-to-treat, ITT analysis change from baseline).

1. The efficacy data are LSMEANs.

2. Treatment success is 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.

April 2026 15

Ascletis Acne Phase 3 Clinical Trial Safety Data*

Denifanstat 50mg was generally well tolerated during the 12-week study

Treatment-emergent adverse events (TEAEs):

• TEAE incidence rates were comparable between denifanstat and placebo

• Only two categories of TEAEs had an incidence rate of 5% or more:

• Dry eye (investigator reported as “dry eye” or “xerophthalmia”) in 10.9% of denifanstat-treated subjects vs 9.2% in the

placebo group*

• Dry skin reported in 6.3% of denifanstat-treated subjects vs 2.9% in the placebo group

Adverse events (AEs):

• All denifanstat-related AEs were mild or moderate

• No denifanstat-related grade 3 or 4 AEs

• No denifanstat-related serious AEs (SAEs)

• No deaths were reported

* Ascletis data on file. The classifications of “dry eye” or “xerophthalmia” were not related to the AE grade.

April 2026 16

Ascletis Acne Open Label Phase 3 Trial*

Denifanstat generally well-tolerated in the open label clinical trial

* Ascletis data on file. Safety and efficacy endpoints of 50 mg denifanstat oral, once daily for 52 weeks versus placebo for 12 weeks and 50mg denifanstat oral once daily for 40 weeks

Treatment-emergent adverse events (TEAEs):

• Only two categories of TEAEs had an incidence rate of 5% or more with dry eye syndrome in 5.5% of denifanstat-treated

subjects and dry skin reported in 5.2% of denifanstat-treated subjects

Adverse events (AEs):

• All denifanstat-related AEs were mild or moderate; no denifanstat-related Grade 3 or 4 AEs; no AE-related permanent

discontinuations; Grade 1 hair thinning in the study was experienced by only 1 denifanstat-treated patient (which resolved

within eight weeks while remaining in study without a change in dose); no deaths were reported

Serious adverse events (SAEs):

• No denifanstat-related SAEs; 2 non-denifanstat-related SAEs (1 breast lump, 1 contusion), both resolved

Efficacy Endpoints (secondary endpoints of the trial) :

• Efficacy endpoints (secondary endpoints of the trial) included the number of subjects with an IGA score decrease by at least 2

points, number of subjects dropping from an IGA score of 3 down to 0 or 1, the percentage reduction in total skin lesion count

and the percentage reduction in inflammatory skin lesion count.

• Subjects treated with denifanstat showed improvements in all efficacy endpoints beyond those observed at 12 weeks

Sagimet’s Upcoming

Development Programs

April 2026 18

Phase 3 Clinical Trial Design for Denifanstat in Acne

• Moderate to severe acne

• Multi-center placebo controlled

• 2:1 randomization

• Double-blind

• Once daily oral dosing

• 800 patients in US

Co-primary endpoints at week 12

• % patients who achieve IGA success (defined as at least a 2-point reduction in IGA from baseline, and an IGA of 0 or 1)

• Absolute change in total skin lesion counts from baseline

• Absolute change in inflammatory skin lesion counts from baseline

Screening

Placebo

N=267

Denifanstat(50mg)

N= 533

Day 1 Week 12

Primary

Efficacy

Denifanstat (50mg)

N~300

Long-Term

Safety

12 week

Double blind clinical trial

40 week

Open label extension

Week 12 Week 52

Planned Phase 3 acne clinical trial

design, pending FDA agreement

April 2026 19

A double-blind, randomized, placebo-controlled clinical trial to assess the safety, tolerability, pharmacokinetics and

pharmacodynamics of single and multiple ascending doses of TVB-3567 in healthy participants with or without acne

• Includes sebum analysis as pharmacodynamic readout

1. SAD = Single ascending dose

2. MAD = Multiple ascending dose.

3. Lipidomic analysis with focus on FASN-derived lipids

ClinicalTrials.gov. NCT06989840. Study SB3567-CLIN-001. https://clinicaltrials.gov/study/NCT06989840

Initiated in June 2025

FASN Inhibitor TVB-3567 FIH Ongoing Phase 1 Clinical Trial

Sebumeter Sebutape

Quantity of Sebum Quality3 of Sebum

PART DESIGN PLANNED # of

PARTICIPANTS

A SAD1 ~56

B Food effect ~12

C MAD2 ~32

D MAD/ACNE ~28

April 2026 20

Potential Clinical Development Program for TVB-3567 in Acne

Step 1 - Phase 1 first-in-human pharmacokinetic (PK) clinical trial of TVB-3567 in healthy volunteers

• PK and pharmacodynamics (PD) evaluation to confirm profile

• Assess safety/tolerability

• Identify potential doses for an acne Phase 2 clinical trial

Step 2 - Phase 2 clinical trial in moderate to severe acne patients

• Upon completion of Phase 1 clinical trial, plan to consult with regulatory authorities regarding Phase 2 clinical trial design,

with goal of initiating Phase 2 clinical trial in 2H 2026

• Phase 2 trial design anticipated to be informed by the results of the Phase 1 clinical trial, expect a 12-week dose ranging

study in moderate to severe acne patients with lesion reduction and treatment success (IGA) as endpoints

Phase 1 clinical trial initiated in June 2025

Goal: Initiate Phase 2 clinical trial in 2026, subject to consultation with regulatory authorities and

outcome of Phase 1 clinical trial

April 2026 21

Denifanstat for Treatment of MASH

Clinical and pre-clinical data demonstrate denifanstat’s potential to treat MASH (metabolic dysfunction-associated steatohepatitis)

• MASH F2-F3:

• Denifanstat met both primary endpoints in Phase 2b clinical trial, with significant reduction in fibrosis and was

generally well-tolerated

• MASH F4:

Combination of denifanstat and resmetirom:

• Pre-clinical data demonstrated synergistic effect of combination of FASN inhibitor and resmetirom

• Phase 1 pharmacokinetics (PK) clinical trial of a combination of denifanstat and resmetirom completed in Dec 2025

• Global license agreement with TAPI enables access to innovative forms of resmetirom API for combination with

denifanstat in a fixed dose combination (FDC) tablet

Next steps

• Plan to complete all development and regulatory activities needed for denifanstat-resmetirom combination Phase 2

readiness by end of 2026

• Further MASH development to be undertaken only upon securing non-dilutive funding

April 2026 22

FASN Inhibition – Significant Opportunity for a Novel Treatment for Acne

FASN Inhibition in Acne

Potential of TVB-3567 in

Acne

• Acne market is significant (~50m people in the US) and aligned to those patients most likely to be

prescribed an oral FASN inhibitor

• Oral FASN inhibitors offer a novel mechanism of action for the potential treatment of moderate to

severe acne

• Topical formulation of a FASN inhibitor in early-stage development for the potential treatment of acne

• First-in-human Phase 1 clinical trial of TVB-3567 initiated in June 2025 for development in acne

• Upon completion of TVB-3567 Phase 1, plan to initiate TVB-3567 Phase 2 in 2026, contingent on

consultation with regulatory authorities

• TVB-3567 IP:

• Composition of matter patent expected to expire in 2035; potential PTE to 2038

• Method of use application for TVB-3567 for acne filed 2025; if granted expected to expire in 2046

Potential of Denifanstat in

Acne

• Denifanstat met all primary and secondary endpoints in Phase 3 clinical trial in patients with moderate to

severe acne vulgaris in China, and NDA accepted by NMPA in December 2025

• Denifanstat generally well-tolerated in both Phase 3 clinical trial and in open-label Phase 3 clinical trial

• Sagimet plans to advance denifanstat into a Phase 3 clinical trial in moderate to severe acne patients for

the US in 2H 2026, contingent on consultation with regulatory authorities

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