Recent Updates
Recently added Catalysts
SGMT Positive Sentiment Score: 75/100

Sagimet Biosciences Reports First Quarter 2025 Financial Results and Provides Corporate Updates Phase 1 clinical trial to evaluate the pharmacokinetics (PK) of a combination of denifanstat and resmetirom expected to init

Key Takeaway: Sagimet Biosciences announced its first quarter 2025 financial results and corporate updates, highlighting the anticipated initiation of a Phase 1 clinical trial for a combination therapy of denifanstat and resmetirom in the second half of 2025. Positive findings from the Phase 2b FASCINATE-2 trial bolster the company's outlook for addressing metabolic dysfunction associated steatohepatitis (MASH). However, the financial loss and rising development costs could pose challenges to its ongoing ventures.

Market Sentiment Analysis

POSITIVE FACTORS

  • Sagimet's Phase 2b FASCINATE-2 trial of denifanstat reported positive results.
  • Initiation of Phase 1 trial for the combination of denifanstat and resmetirom showcases confidence in clinical development.
  • Potential to serve patient groups with stage 4 fibrosis could expand treatment options significantly.

CONCERNS & RISKS

  • The company reported a net loss of $18,176,000 for the quarter ended March 31, 2025, indicating financial challenges.
  • Research and development expenses have increased significantly, creating concerns about resource allocation.

Full Press Release Details

Sagimet Biosciences Reports First Quarter 2025
Financial Results and Provides Corporate Updates
Phase 1 clinical trial to evaluate the pharmacokinetics (PK)
of a combination of denifanstat and resmetirom expected to initiate in 2H 2025; data readout expected 1H 2026
San Mateo, Calif., May 8, 2025 - 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 quarter ended March 31, 2025, and provided recent corporate updates.
"Sagimet is committed to bringing innovative therapies to MASH
patients, following the successful results of our Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly
in more advanced F3 stage patients. In a Phase 1 clinical trial in patients with and without hepatic impairment, denifanstat exhibited
similar pharmacokinetic characteristics and was well tolerated among all groups. Considering these strong Phase 1 and Phase 2 data, further
development of denifanstat in MASH, including as part of a combination program, could potentially offer an opportunity to serve patient
groups with the strongest need of treatment including those with stage 4 fibrosis," said David Happel, Chief Executive Officer of
Sagimet. "Building on our presentation of compelling preclinical data at 2024 EASL demonstrating the synergistic effect of a FASN
inhibitor combined with resmetirom on important liver disease markers, we anticipate initiating a Phase 1 clinical trial to evaluate the
PK and tolerability of a combination of denifanstat and resmetirom in the second half of 2025. If the outcome of this Phase 1 trial is
positive, we will explore moving into the development of a combination product -- which we envision as a single tablet -- for patients
living with MASH. We remain strongly convinced of the significant therapeutic potential associated with FASN inhibition across multiple
Recent Corporate Highlights
Rohit Loomba, M.D., M.H.Sc., Professor of Medicine,
Chief, Division of Gastroenterology and Hepatology, and Director, MASLD Research Center, University of California San Diego,
said, "I'm excited to see Sagimet initiate development of a combination of denifanstat and resmetirom with this Phase 1 PK
trial which will potentially answer important questions about the compatibility of these two molecules in humans. Results of this
Phase 1 trial, if successful, could lead to further development of a combination of Sagimet's fat synthesis inhibitor, denifanstat,
with a fat oxidizer in MASH patients, potentially including those with stage 4 fibrosis."
Publications and Presentations
Anticipated Upcoming Milestones
Financial Results for the Three Months Ended March 31, 2025
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical
company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways
in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet's lead drug candidate, denifanstat, is an oral,
once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH).
FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with
positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with
moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been
successfully completed, supporting the advancement of denifanstat into further development. Sagimet's second FASN inhibitor, TVB-3567,
a potent and selective small molecule FASN inhibitor, received IND clearance in March 2025, allowing initiation of a first-in-human
Phase 1 clinical trial in acne. For additional information about Sagimet, please visit www.sagimet.com.
Metabolic-dysfunction associated steatohepatitis
(MASH) is a progressive and severe liver disease which is estimated to impact more than 115 million people worldwide, for which there
is only one recently approved treatment in the United States and no currently approved treatments in Europe. In 2023, global
liver disease medical societies and patient groups formalized the decision to rename non-alcoholic fatty liver disease (NAFLD) to metabolic
dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to MASH. Additionally, an overarching term,
steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. The
goal of the name change was to establish an affirmative, non-stigmatizing name and diagnosis.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of
1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts
or current conditions, including but not limited to, statements regarding: the expected timing of the presentation of data from ongoing
clinical trials, Sagimet's clinical development plans and related anticipated development milestones, Sagimet's cash and financial
resources and expected cash runway. These statements involve known and unknown risks, uncertainties and other important factors that may
cause Sagimet's actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as "may,"
"might," "will," "should," "expect," "plan," "aim," "seek,"
"anticipate," "could," "intend," "target," "project," "contemplate,"
"believe," "estimate," "predict," "forecast," "potential" or "continue"
or the negative of these terms or other similar expressions.
The forward-looking statements in this press release are only predictions.
Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial
trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements
speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot
be predicted or quantified and some of which are beyond Sagimet's control, including, among others: the clinical development and
therapeutic potential of denifanstat or any other drug candidates Sagimet may develop; Sagimet's ability to advance drug candidates
into and successfully complete clinical trials 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
SAGIMET BIOSCIENCES INC.
CONDENSED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(in thousands, except for share
and per share amounts)
Three Months Ended March 31,
2025 2024
(unaudited)
Operating expenses:
Research and development 15,342 5,262
General and administrative 4,523 3,506
Total operating expenses 19,865 8,768
Loss from operations (19,865 ) (8,768 )
Total other income 1,689 2,139
Net loss $ (18,176 ) $ (6,629 )
Net loss per share, basic and diluted $ (0.56 ) $ (0.23 )
Weighted-average shares outstanding, basic and diluted 32,195,345 29,039,427
Net loss $ (18,176 ) $ (6,629 )
Other comprehensive loss:
Net unrealized loss on marketable securities (109 ) (23 )
Total comprehensive loss $ (18,285 ) $ (6,652 )
SAGIMET BIOSCIENCES INC.
CONDENSED BALANCE SHEETS
As of
March 31, 2025 December 31, 2024
Cash, cash equivalents and marketable securities $ 144,569 $ 158,658
Total assets $ 146,172 $ 160,259
Current liabilties $ 7,180 $ 4,454
Stockholders' equity $ 138,992 $ 155,805
Liabilities and stockholders' equity $ 146,172 $ 160,259

Frequently Asked Questions

What is denifanstat used for?

Denifanstat is developed for treating metabolic dysfunction associated steatohepatitis (MASH).

When will the Phase 1 trial for denifanstat and resmetirom start?

The Phase 1 trial is expected to begin in the second half of 2025.

What designation has denifanstat received from the FDA?

Denifanstat has been granted Breakthrough Therapy designation by the FDA.

What are the financial results for Sagimet for Q1 2025?

Sagimet reported a net loss of $18.176 million for the first quarter of 2025.

What is Sagimet's lead drug candidate?

Sagimet's lead drug candidate is denifanstat, an oral FASN inhibitor.

Last updated: May 8, 2025