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Sagimet Biosciences Reports Third Quarter 2024 Financial Results and Provides Corporate Updates Denifanstat received Breakthrough Therapy designation from FDA for MASH Results from Phase 2b FASCINATE-2 study of denifanst

Key Takeaway: Sagimet Biosciences has reported its financial results for the third quarter of 2024, showing a net loss of $14.6 million. The company has received Breakthrough Therapy designation from the FDA for its lead drug candidate, denifanstat, aimed at treating metabolic dysfunction-associated steatohepatitis (MASH). Additionally, positive results from the Phase 2b FASCINATE-2 study were published in The Lancet, bolstering expectations for the Phase 3 program set to begin by the end of 2024. Sagimet's financial position reflects $170.0 million in cash and marketable securities as of September 30, 2024.

Market Sentiment Analysis

POSITIVE FACTORS

  • Denifanstat received Breakthrough Therapy designation from the FDA for MASH.
  • Phase 2b FASCINATE-2 study results published in The Lancet, showing strong efficacy.
  • Leadership expressed confidence in upcoming Phase 3 program initiation by end of 2024.

CONCERNS & RISKS

  • The company reported a significant net loss of $14.6 million for Q3 2024.
  • Operating expenses have risen, with R&D costs increasing notably from the previous year.

Full Press Release Details

Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
Denifanstat received
Breakthrough Therapy designation from FDA for MASH
Phase 2b FASCINATE-2 study of denifanstat published in The Lancet Gastroenterology & Hepatology
Successful completion
of end-of-Phase 2 interactions with FDA on the development of denifanstat for MASH; Phase 3 program initiation expected by end of 2024
runway through 2025, with cash, cash equivalents and marketable securities totaling $170.0 million as of September 30, 2024
Mateo, Calif., November 14, 2024 - 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 third quarter ended September 30, 2024, and provided recent corporate updates.
"As we approach the end of 2024,
the Sagimet team remains focused on advancing denifanstat towards a pivotal Phase 3 program in MASH," said David Happel, Chief
Executive Officer of Sagimet. "The publication of our Phase 2b FASCINATE-2 study results in a highly regarded Lancet journal
highlighted denifanstat's strong efficacy and tolerability data and its highly differentiated mechanism of action which enables
denifanstat to improve the key drivers of MASH: fat accumulation, inflammation, and fibrosis. In addition, we are proud to have recently
received Breakthrough Therapy designation for denifanstat in MASH from the FDA, demonstrating denifanstat's potential to address
the significant unmet need for new therapies for this serious disease, and, with the successful completion of end-of-Phase 2 interactions
with FDA, we look forward to initiating our planned Phase 3 program for denifanstat by the end of 2024."
Recent Corporate Highlights
Anticipated Upcoming Milestones
Financial Results for the Three Months
Ended September 30, 2024
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 MASH. FASCINATE-2,
a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive
results. 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.
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; 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
CONDENSED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
except for share and per share amounts)
Three Months Ended September 30, Nine Months Ended September 30,
2024 2023 2024 2023
License revenue $ - $ 2,000 $ - $ 2,000
Operating expenses:
Research and development 12,653 4,958 24,228 14,121
General and administrative 4,249 4,494 12,031 9,153
Total operating expenses 16,902 9,452 36,259 23,274
Loss from operations (16,902 ) (7,452 ) (36,259 ) (21,274 )
Total other income 2,283 1,099 6,893 1,549
Net loss $ (14,619 ) $ (6,353 ) $ (29,366 ) $ (19,725 )
Net loss per share, basic and diluted $ (0.45 ) $ (0.35 ) $ (0.95 ) $ (3.22 )
Weighted-average shares outstanding, basic and diluted 32,143,336 18,194,682 31,036,271 6,131,541
Net loss $ (14,619 ) $ (6,353 ) $ (29,366 ) $ (19,725 )
Other comprehensive income:
Net unrealized income on marketable securities 464 - 411 84
Total comprehensive loss $ (14,155 ) $ (6,353 ) $ (28,955 ) $ (19,641 )
As of
September 30, 2024 December 31, 2023
Cash, cash equivalents and marketable securities $ 169,957 $ 94,897
Total assets $ 174,775 $ 96,719
Current liabilties $ 4,092 $ 5,654
Stockholders' equity $ 170,683 $ 91,065
Liabilities and stockholders' equity $ 174,775 $ 96,719

Frequently Asked Questions

What designation did denifanstat receive from the FDA?

Denifanstat received Breakthrough Therapy designation for MASH from the FDA.

Where were the Phase 2b study results of denifanstat published?

The Phase 2b FASCINATE-2 study results were published in The Lancet Gastroenterology.

What is MASH and its significance?

MASH is a severe liver disease affecting over 115 million people globally.

What is the cash position of Sagimet as of September 2024?

Sagimet has $170.0 million in cash, cash equivalents, and marketable securities.

When does Sagimet plan to initiate its Phase 3 program?

Sagimet expects to initiate the Phase 3 program for denifanstat by late 2024.

Last updated: Nov 14, 2024