Full Press Release Details
Sagimet Biosciences Reports Fourth Quarter
and Full Year 2025 Financial Results
and Provides Corporate Updates
Completed Phase 1 pharmacokinetic (PK) clinical
trial of denifanstat and resmetirom combination
Phase 2 trial of denifanstat/resmetirom combination
in F4 MASH patients planned to
Secured global, exclusive license to TAPI's
innovative forms of resmetirom active pharmaceutical
First-in-human Phase 1 clinical trial of FASN
inhibitor TVB-3567 ongoing
Positive topline results in open-label Phase
3 trial evaluating the long-term safety of denifanstat in
patients with moderate to severe acne in China reported by Ascletis
China's National Medical Products Administration
(NMPA) accepted Ascletis' New Drug Application
(NDA) for denifanstat for the treatment of moderate to severe acne
Mateo, Calif., March 11, 2026 - Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company
developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the fourth
quarter and full year ended December 31, 2025, and provided recent corporate updates.
"2025 saw important advances in both our MASH and acne programs,"
said David Happel, Chief Executive Officer of Sagimet. "We completed our Phase 1 PK clinical trial of denifanstat and resmetirom
combination and anticipate advancing the combination into a proof-of-concept Phase 2 clinical trial in F4 MASH, for which there are currently
no approved treatments, in the second half of the year. In acne, positive 52-week data from our license partner Ascletis' Phase
3 open-label acne trial with denifanstat will support Ascletis' NDA that was accepted by the Chinese NMPA. We anticipate further
exploring the potential role of FASN inhibition in acne in clinical development in 2026."
Recent Corporate Highlights
Clinical and Regulatory Updates
Publications and Presentations
Anticipated Upcoming Milestones
Financial Results for the Full Year Ended December 31, 2025
About Sagimet Biosciences
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. Denifanstat, an oral, once-daily pill, met all
primary endpoints in its Phase 2b FASCINATE-2 clinical trial in MASH, as well as all primary and secondary endpoints in Sagimet's
license partner for China's Phase 3 clinical trial in moderate-to-severe acne. A combination of denifanstat and resmetirom was
tested in a Phase 1 PK clinical trial and is planned to be developed for patients with MASH cirrhosis (F4). TVB-3567, a second oral FASN
inhibitor which is planned to be developed for acne, is currently being tested in a Phase 1 first-in-human clinical trial. For additional
information about Sagimet, please visit www.sagimet.com.
MASH is a progressive and severe liver disease
which is estimated to impact more than 265 million people worldwide1. MASH is characterized by the build-up of fat in the
liver and various degrees of inflammation and fibrosis along with systemic metabolic changes including dyslipidemia (increased fat levels
in blood) and insulin resistance. Patients with moderate to severe disease who have advanced fibrosis (F3) or cirrhosis (F4) have the
highest risk of liver-related outcomes such as decompensation, hepatocellular carcinoma, and liver transplantation. There are few approved
treatments for non-cirrhotic MASH (stages F1, F2 and F3 fibrosis) and no approved treatments for MASH cirrhosis (F4).
Over 50 million people suffer from acne in
the U.S., with 5.1 million acne patients treated by dermatologists annually, making it one of the most prevalent skin diseases addressed
by physicians.2,3 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. Adherence to topical therapies is lower than with oral agents, with an estimated 30% to
40% of patients not adhering to their topical treatments.4
Patients with acne vulgaris have increased
sebum production compared to non-acne populations which contributes to the pathogenesis of the disease. Increased sebum production is
due to increased de novo lipogenesis (DNL) locally in the sebocytes. FASN is the last committed step in the DNL pathway which produces
the majority (>80%) of key sebum lipids such as palmitate and sapienic acid in acne, and FASN also contributes to inflammatory pathways,
making the inhibition of FASN a potentially impactful approach to address acne.
1. Younossi ZM, et al. Hepatology.
2023;77(4): 1335-1347.
2. Bickers DR, et al. J Am Acad Dermatol.
3. American Academy of Dermatology. Burden
of Skin Disease. 2017. www.aad.org/BSD.
4. Purvis CG, et al. Ann Pharmacother.
2021;55(10):1297-1299.
Forward-Looking Statements
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, Sagimet's cash and financial resources and expected cash runway 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.
LifeSci Communications
SAGIMET BIOSCIENCES INC.
OPERATIONS AND COMPREHENSIVE LOSS
except for share and per share amounts)
| Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (unaudited) | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 6,734 | $ | 14,216 | $ | 39,054 | $ | 38,444 | ||||||||
| General and administrative | 4,031 | 3,979 | 17,835 | 16,010 | ||||||||||||
| Total operating expenses | 10,765 | 18,195 | 56,889 | 54,454 | ||||||||||||
| Loss from operations | (10,765 | ) | (18,195 | ) | (56,889 | ) | (54,454 | ) | ||||||||
| Total other income | 1,197 | 1,994 | 5,851 | 8,887 | ||||||||||||
| Net loss | $ | (9,568 | ) | $ | (16,201 | ) | $ | (51,038 | ) | $ | (45,567 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.29 | ) | $ | (0.50 | ) | $ | (1.58 | ) | $ | (1.45 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 32,521,599 | 32,195,345 | 32,345,525 | 31,350,725 | ||||||||||||
| Net loss | $ | (9,568 | ) | $ | (16,201 | ) | $ | (51,038 | ) | $ | (45,567 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Net unrealized gain (loss) on marketable securities | 3 | (211 | ) | (110 | ) | 200 | ||||||||||
| Total comprehensive loss | $ | (9,565 | ) | $ | (16,412 | ) | $ | (51,148 | ) | $ | (45,367 | ) |
SAGIMET BIOSCIENCES INC.
(in thousands, except for share and
| As of | ||||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Cash, cash equivalents and marketable securities | $ | 113,124 | $ | 158,658 | ||||
| Total assets | $ | 116,482 | $ | 160,259 | ||||
| Current liabilties | $ | 5,101 | $ | 4,454 | ||||
| Stockholders' equity | $ | 111,381 | $ | 155,805 | ||||
| Liabilities and stockholders' equity | $ | 116,482 | $ | 160,259 |