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Sagimet Biosciences Reports Full Year 2024 Financial Results and Provides Corporate Updates Denifanstat Phase 3 MASH program initiated in Q4 2024; patient screening expected to start in 1H 2025 Denifanstat received Break

Key Takeaway: Sagimet Biosciences has reported its financial results for the year 2024, highlighting the initiation of its Phase 3 MASH program for denifanstat and receiving Breakthrough Therapy designation from the FDA. The company also provided updates on another drug candidate, TVB-3567, which has received IND clearance for clinical development targeting acne. Despite these advancements, Sagimet faced a significant net loss of $45.6 million for the year, alongside rising operating expenses, which raised concerns about its financial sustainability in the near future.

Market Sentiment Analysis

POSITIVE FACTORS

  • Denifanstat's Phase 3 MASH program has been initiated.
  • Breakthrough Therapy designation granted by the FDA for denifanstat.
  • Successful Phase 2b results for denifanstat reported in 2024.
  • TVB-3567 has received IND clearance and is moving into clinical development.

CONCERNS & RISKS

  • Sagimet reported a net loss of $45.6 million for the year 2024.
  • Operating expenses increased significantly compared to 2023.
  • Continued reliance on successful clinical trial outcomes to drive progress.
  • Management's caution around forward-looking statements and future uncertainties.

Full Press Release Details

Sagimet Biosciences Reports Full Year 2024 Financial
Results and Provides Corporate Updates
Denifanstat Phase 3 MASH program initiated in
Q4 2024; patient screening expected to start in 1H 2025
Denifanstat received Breakthrough Therapy designation
Clearance of Investigational New Drug (IND)
application for FASN Inhibitor TVB-3567, to be developed for the treatment of acne
Calif., March 12, 2025 - Sagimet Biosciences Inc. (Nasdaq: SGMT), clinical-stage biopharmaceutical company developing
novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the full year ended December 31,
2024, and provided recent corporate updates.
"2024 was a highly productive year for Sagimet, and we're
carrying that momentum into a strong start for 2025," said David Happel, Chief Executive Officer of Sagimet. "We are pleased
to have initiated our Phase 3 denifanstat program in MASH, with site activation and patient pre-screening underway and patient screening
expected to begin soon. With the successful Phase 2b FASCINATE-2 results we reported in 2024, and Breakthrough Therapy designation granted
by the FDA, we are confident in denifanstat's potential to address the significant unmet need for patients living with MASH. At
the same time, we are excited to advance a second Fatty Acid Synthase inhibitor, TVB-3567, into the clinic for the potential treatment
of moderate to severe acne, following IND clearance. Given the potential of FASN inhibition across multiple disease states, we look forward
to progressing both denifanstat and TVB-3567 in the coming year."
Full Year and Recent Corporate Highlights
Clinical and Regulatory Updates
Publications and Presentations
Anticipated Upcoming Milestones
Financial Results for the Full Year Ended December 31, 2024
About Sagimet Biosciences
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 Phase 3 development in MASH. 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.
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,
including its Phase 3 denifanstat program and Phase 1 acne program; 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.
SAGIMET BIOSCIENCES INC.
STATEMENTS OF OPERATIONS AND
(in thousands, except for share
and per share amounts)
Three Months Ended December 31, Years Ended December 31,
2024 2023 2024 2023
(unaudited)
License revenue $ - $ - $ - $ 2,000
Operating expenses:
Research and development 14,216 5,656 38,444 19,777
General and administrative 3,979 3,810 16,010 12,963
Total operating expenses 18,195 9,466 54,454 32,740
Loss from operations (18,195 ) (9,466 ) (54,454 ) (30,740 )
Total other income 1,994 1,315 8,887 2,864
Net loss $ (16,201 ) $ (8,151 ) $ (45,567 ) $ (27,876 )
Net loss per share, basic and diluted $ (0.50 ) $ (0.36 ) $ (1.45 ) $ (2.66 )
Weighted-average shares outstanding, basic and diluted 32,195,345 22,895,892 31,350,725 10,460,335
Net loss $ (16,201 ) $ (8,151 ) $ (45,567 ) $ (27,876 )
Other comprehensive (loss) income:
Net unrealized (loss) income on marketable securities (211 ) 30 200 114
Total comprehensive loss $ (16,412 ) $ (8,121 ) $ (45,367 ) $ (27,762 )
SAGIMET BIOSCIENCES INC.
As of
December 31, December 31,
2024 2023
Cash, cash equivalents and marketable securities $ 158,658 $ 94,897
Total assets $ 160,259 $ 96,719
Current liabilties $ 4,454 $ 5,654
Stockholders' equity $ 155,805 $ 91,065
Liabilities and stockholders' equity $ 160,259 $ 96,719

Frequently Asked Questions

What is the purpose of denifanstat in Sagimet's pipeline?

Denifanstat is a selective FASN inhibitor targeting metabolic dysfunction associated with MASH.

What recent recognition did denifanstat receive from the FDA?

Denifanstat was granted Breakthrough Therapy designation for treating non-cirrhotic MASH.

When is patient screening for denifanstat expected to start?

Patient screening for the denifanstat Phase 3 program is anticipated to begin in 1H 2025.

What is the new development for TVB-3567?

TVB-3567 has received IND clearance to be developed as a treatment for moderate to severe acne.

What are Sagimet's financial results for 2024?

Sagimet reported a net loss of $45.57 million for the year ended December 31, 2024.

Last updated: Mar 12, 2025