Form 8-K
8-K — Sagimet Biosciences Inc.
Accession: 0001104659-26-048971
Filed: 2026-04-27
Period: 2026-04-27
CIK: 0001400118
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Regulation FD Disclosure
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — tm2612738d2_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (tm2612738d2_ex99-1.htm)
EX-99.2 — EXHIBIT 99.2 (tm2612738d2_ex99-2.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 2.02
Results of Operations and Financial Condition.
Sagimet Biosciences, Inc. (the “Company”)
is furnishing with this Current Report on Form 8-K (the “Current Report”) certain unaudited preliminary financial information
for the Company’s fiscal quarter ended March 31, 2026.
Certain Unaudited Preliminary Financial
Information
The Company estimates that its cash, cash equivalents and marketable
securities were approximately $104.5 million as of March 31, 2026. This amount is unaudited and preliminary and is subject to completion
of financial closing procedures, including the completion of management’s reviews. As a result, this amount reflects the Company’s
preliminary estimate with respect to such information, based on information currently available for management, and may vary from the
Company’s actual financial position as of March 31, 2026. Further, this preliminary estimate is not a comprehensive statement
or estimate of the Company’s financial data or financial condition as of March 31, 2026. The unaudited preliminary financial
data included in this Current Report on Form 8-K have been prepared by, and are the responsibility of, the Company’s management
team. KPMG LLP, the Company’s independent registered public accounting firm, has not audited, reviewed, examined, compiled, nor
applied agreed-upon procedures with respect to the unaudited preliminary financial data. Accordingly, KPMG LLP does not express an opinion
or any other form of assurance with respect thereto. It is possible that the Company may identify items that require the Company to make
adjustments to the financial information set forth above. This preliminary estimate should not be viewed as a substitute for financial
statements prepared in accordance with generally accepted accounting principles in the United States and it is not necessarily indicative
of the balance to be achieved in any future period. Additional information and disclosure would be required for a more complete understanding
of the Company’s financial position and results of operations as of March 31, 2026. Accordingly, no undue reliance should be
placed on this preliminary estimate. The estimates should be read together with the Company’s audited consolidated financial statements
and related notes and the Company’s other financial information reported in the Company’s Annual Report on Form 10-K
for the fiscal year ended December 31, 2025. The Company undertake no obligation to update or revise these amounts as a result of
new information or otherwise.
The information furnished pursuant to this Item 2.02 is intended to
be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated
by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 7.01
Regulation FD Disclosure.
On April 27, 2026, 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 Exchange Act, nor shall Exhibit 99.1 furnished herewith be deemed incorporated by reference
in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01
Other Events.
On April 27, 2026, the Company issued
a press release announcing certain strategic and corporate updates. The full text of the press release is filed as Exhibit 99.2 to
this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01
Financial Statements and Exhibits
(d) Exhibits
Exhibit
No.
Document
99.1
Investor Presentation of Sagimet Biosciences Inc., dated April 27, 2026.
99.2
Press Release 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: tm2612738d2_ex99-1.htm · Sequence: 2
Exhibit 99.1
Targeting MetabolicDysfunction
with Novel Therapeutics
April 2026
Confidential and proprietary information of Sagimet Biosciences Inc.
Confidential and proprietary information of Sagimet Biosciences Inc. 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 ofrisks, 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; risks and uncertainties related to market conditions; 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 Exchange Commission (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 managementto predict allrisk factors and
uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any
new information,futureevents,changedcircumstances orotherwise.
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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 *
*Cash, cash equivalents and marketable securities; 3/31/2026 cash on hand unaudited, preliminary and subject to change
IP Portfolio
Cash Position
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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.
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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.
Confidential and proprietary information of Sagimet Biosciences Inc. 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.
Confidential and proprietary information of Sagimet Biosciences Inc. 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.
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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
Confidential and proprietary information of Sagimet Biosciences Inc. 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
EX-99.2 — EXHIBIT 99.2
EX-99.2
Filename: tm2612738d2_ex99-2.htm · Sequence: 3
Exhibit 99.2
Sagimet Biosciences
Provides Strategic and Corporate Updates
Phase
3 clinical trial of denifanstat in moderate to severe acne patients for the U.S.
planned
to initiate in second half of 2026
First-in-human
Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing
Further MASH
development to be undertaken only upon securing non-dilutive funding
Sagimet to host
a KOL event and webcast, April 30 at 2 pm ET
San
Mateo, Calif., April 27, 2026 – Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage
biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today provided strategic
and corporate updates.
“Building on the recent successful
Phase 3 clinical trial in China of our lead molecule denifanstat in moderate to severe acne, we have taken the strategic decision to
advance denifanstat in acne for the U.S., starting with a Phase 3 clinical trial expected to begin in the second half of 2026,”
said David Happel, Chief Executive Officer of Sagimet. “We believe the large moderate to severe acne patient population is
underserved by the currently approved treatments. Denifanstat, if approved, would be a convenient, once-daily oral medication and the
first innovative oral treatment for acne in more than forty years.”
Fatty acid synthase (FASN) inhibition,
with its ability to reduce sebum production and address local inflammation, represents a potential novel approach to treat moderate to
severe acne vulgaris, a condition impacting an estimated 10 million people in the U.S. annually. The Company recently announced
positive topline results in the open-label Phase 3 clinical trial conducted and reported by its license partner that evaluated the long-term
safety of denifanstat tablets in patients with moderate to severe acne in China.
“We are prioritizing our dermatology
franchise in our capital allocation,” said Thierry Chauche, Chief Financial Officer, “and we plan to pursue non-dilutive
funding options for our MASH program.”
Recent Corporate Highlights
· Sagimet
plans to initiate a Phase 3 clinical trial of denifanstat in moderate to severe acne patients
for the U.S. in the second half of 2026, subject to Investigational New Drug (IND) clearance.
· In
January 2026, positive topline results were reported in the open-label Phase 3 trial
(n=240) evaluating the long-term safety of 50 mg once-daily denifanstat in patients with
moderate to severe acne in China by Sagimet’s license partner Ascletis Bioscience Co.
Ltd. (Ascletis). Denifanstat was generally well-tolerated, and subjects treated with denifanstat
showed improvements in all efficacy endpoints measured at 52 weeks (secondary endpoints of
the trial).
· First-in-human
Phase 1 clinical trial of FASN inhibitor TVB-3567 is ongoing.
· The
Company also plans to develop a topical formulation of a FASN inhibitor for the potential
treatment of acne.
· In
relation to its development program for the combination of denifanstat and resmetirom in
metabolic dysfunction associated steatohepatitis (MASH), the Company reported the completion
of its Phase 1 PK clinical trial in December 2025. The Company anticipates that the
denifanstat and resmetirom combination program will be ready to advance into Phase 2 in the
second half of 2026. The Company will undertake no further clinical development in MASH until
non-dilutive financing is achieved.
· In
April 2026, Sagimet announced the appointment of Andreas Grauer, MD, as Chief Medical
Officer, and the retirement of its former Chief Medical Officer, Eduardo Bruno Martins, MD,
DPhil. Dr. Grauer brings more than two decades of global biopharmaceutical leadership
experience, with deep expertise spanning clinical development, medical affairs, and regulatory
strategy across multiple therapeutic areas.
Publications and Presentations
· In April 2026,
Sagimet presented analyses from the Phase 2b FASCINATE-2 trial of denifanstat in MASH of
bile acid biomarkers to measure denifanstat response at the Fueling MASH: Metabolic Drivers
and Inflammatory Crosstalk Keystone Symposium.
Anticipated Upcoming Milestones
· The
Company plans to file an IND application for denifanstat for the treatment of moderate to
severe acne in mid-2026.
· Following
IND clearance, Sagimet anticipates advancing denifanstat into a registrational Phase 3 clinical
trial in moderate to severe acne patients in the second half of 2026.
· Upon
completion of the Phase 1 clinical trial of TVB-3567, subject to consultation with regulatory
authorities, Sagimet plans to initiate a Phase 2 clinical trial with TVB-3567 in moderate
to severe acne patients in the second half of 2026.
Conference Call Information
Sagimet Biosciences will host a virtual
KOL event with Dr. Julie Harper to discuss its planned development of denifanstat for acne on April 30. 2026 at 2pm ET.
Live
webcast available : https://lifescievents.com/event/ha9t02g/
About Sagimet Biosciences
Sagimet
is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic
pathways in conditions resulting from the overproduction of the fatty acid, palmitate. FASN is a regulator of lipid synthesis, and a
key pathway implicated in multiple diseases, such as acne, MASH and certain FASN-dependent tumor types. For additional information
about Sagimet, please visit www.sagimet.com.
About Acne
Acne is one of the most common skin
conditions in the U.S., with approximately 50 million Americans affected annually and more than 5 million seeking medical treatment for
acne each year. Acne affects around 85% of persons between the ages of 12 and 24. Moderate to severe acne accounts for 20% of acne sufferers,
or approximately 10 million people in the U.S. annually. 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.
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 timelines and anticipated development milestones, are
forward-looking statements. 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, TVB-3567 or any other drug candidates or combination therapies developed by Sagimet; Sagimet’s
ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship
with Ascletis, and the success of its development efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its
capital requirements and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These
and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings
with the Securities and Exchange Commission and available at 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.
Investor Contact:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
Media Contact:
Maggie Whitney
LifeSci Communications
mwhitney@lifescicomms.com
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