Full Press Release Details
Reports First Quarter 2024 Financial Results and Provides Corporate Updates
2b FASCINATE-2 clinical data to be presented as an oral presentation at the EASL International Liver Congress 2024 taking place in Milan, Italy
2 meeting with U.S. Food and Drug Administration (FDA) expected in the second quarter of 2024
are underway to start a pivotal Phase 3 trial evaluating denifanstat in patients with metabolic dysfunction-associated steatohepatitis
(MASH) in the second half of 2024
cash runway through 2025 with cash, cash equivalents and marketable securities totaling $193.7 million as of March 31,
San Mateo, Calif., May 13, 2024
- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid
synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today reported financial results for the
quarter ended March 31, 2024, and provided recent corporate updates.
"Sagimet continues to focus on
advancing the clinical development of denifanstat in MASH," said David Happel, Chief Executive Officer of Sagimet. "In the
first quarter of 2024, we announced the Phase 2b FASCINATE-2 clinical trial met both primary efficacy endpoints and demonstrated statistically
significant reduction in fibrosis, and our successful completion of a follow-on offering netting $104.7 million in proceeds. We look
forward to presenting the full FASCINATE-2 Phase 2b 52-week biopsy results at EASL in June 2024. We plan to start a Phase 3 clinical
trial of denifanstat in MASH in the second half of 2024 following the End-of-Phase 2 meeting with the FDA expected in the second quarter
Recent Corporate Highlights
Anticipated Upcoming Milestones
Financial Results for the Three Months
Ended March 31, 2024
Sagimet 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 metabolic dysfunction-associated steatohepatitis (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.
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, 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
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
thousands, except for share and per share amounts)
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 5,262 | $ | 4,487 | ||||
| General and administrative | 3,506 | 2,278 | ||||||
| Total operating expenses | 8,768 | 6,765 | ||||||
| Loss from operations | (8,768 | ) | (6,765 | ) | ||||
| Other income, net: | ||||||||
| Change in fair value of stock warrant liability | - | (2 | ) | |||||
| Interest income and other | 2,139 | 180 | ||||||
| Net loss | $ | (6,629 | ) | $ | (6,587 | ) | ||
| Other comprehensive gain (loss): | ||||||||
| Net unrealized gain (loss) on marketable securities | (23 | ) | 71 | |||||
| Total other comprehensive gain (loss) | (23 | ) | 71 | |||||
| Comprehensive loss | $ | (6,652 | ) | $ | (6,516 | ) | ||
| Net loss per share, basic and diluted | $ | (0.23 | ) | $ | (35.58 | ) | ||
| Weighted-average shares outstanding, basic and diluted | 29,039,427 | 185,137 |
| As of | ||||||||
| March 31, 2024 | December 31, 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 193,705 | $ | 94,897 | ||||
| Total assets | $ | 194,528 | $ | 96,719 | ||||
| Current liabilties | $ | 4,510 | $ | 5,654 | ||||
| Stockholders' equity | $ | 190,018 | $ | 91,065 | ||||
| Liabilities and stockholders' equity | $ | 194,528 | $ | 96,719 |