Full Press Release Details
Sagimet Biosciences Reports Second Quarter 2024
Financial Results and Provides Corporate Updates
Denifanstat Phase 2b FASCINATE-2 clinical trial
52-week data was presented in June at the European Association for the Study of the Liver (EASL) Congress
Preparations are ongoing to initiate a Phase
3 clinical development program for denifanstat in patients with metabolic dysfunction-associated steatohepatitis (MASH) in the second
Two biotechnology industry leaders, Anne Phillips
and Jennifer Jarrett, joined the Board of Directors effective August 1, 2024
Anticipated cash runway through 2025 with cash,
cash equivalents and marketable securities totaling $188.5 million as of June 30, 2024
Mateo, Calif., August 14, 2024 - Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company
developing novel therapeutics targeting dysfunctional metabolic pathways, today reported financial results for the second quarter ended
June 30, 2024, and provided recent corporate updates.
"In June, we presented the full Phase 2b FASCINATE-2 clinical
trial 52-week biopsy results at EASL showing denifanstat's statistically significant fibrosis reduction in advanced F2 and F3 patients
and a statistically significant delay in progression to cirrhosis," said David Happel, Chief Executive Officer of Sagimet. "We
believe these encouraging data, which demonstrate denifanstat's mechanism of action as the only fat synthesis inhibitor that directly
targets the three key drivers of MASH -- fat accumulation, inflammation, and fibrosis -- differentiate denifanstat from other therapeutics
in the field. We plan to initiate the Phase 3 program for denifanstat in MASH in the second half of 2024 and intend to share the Phase
3 pivotal trial design later in the year. We look forward to progressing the development of denifanstat for patients living with MASH,
a condition which has grown to epidemic levels worldwide."
Recent Corporate Highlights
Anticipated Upcoming Milestones
Financial Results for the Three and Six Months Ended June 30,
About Sagimet Biosciences
is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional
metabolic 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.
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; 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.
CONDENSED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(in thousands, except for share
and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 6,313 | $ | 4,676 | $ | 11,575 | $ | 9,163 | ||||||||
| General and administrative | 4,276 | 2,381 | 7,782 | 4,659 | ||||||||||||
| Total operating expenses | 10,589 | 7,057 | 19,357 | 13,822 | ||||||||||||
| Loss from operations | (10,589 | ) | (7,057 | ) | (19,357 | ) | (13,822 | ) | ||||||||
| Interest income and other | 2,471 | 272 | 4,610 | 450 | ||||||||||||
| Net loss | $ | (8,118 | ) | $ | (6,785 | ) | $ | (14,747 | ) | $ | (13,372 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Net unrealized income (loss) on marketable securities | (30 | ) | 13 | (53 | ) | 84 | ||||||||||
| Comprehensive loss | $ | (8,148 | ) | $ | (6,772 | ) | $ | (14,800 | ) | $ | (13,288 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.25 | ) | $ | (35.80 | ) | $ | (0.48 | ) | $ | (71.39 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 31,913,887 | 189,520 | 30,476,657 | 187,314 |
SAGIMET BIOSCIENCES INC.
CONDENSED BALANCE SHEETS
| As of | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 188,491 | $ | 94,897 | ||||
| Total assets | $ | 189,020 | $ | 96,719 | ||||
| Current liabilties | $ | 5,728 | $ | 5,654 | ||||
| Stockholders' equity | $ | 183,292 | $ | 91,065 | ||||
| Liabilities and stockholders' equity | $ | 189,020 | $ | 96,719 |