Full Press Release Details
Reports Third Quarter 2023 Financial Results and Provides Corporate Updates
topline week 52 liver biopsy results from Phase 2b FASCINATE-2 trial with denifanstat in the first quarter of 2024
including late-breaker, accepted at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting
120 patients in Phase 3 registrational trial of denifanstat in recurrent glioblastoma (GBM) announced by license partner, Ascletis
of positive topline Phase 2 denifanstat monotherapy data from Ascletis' acne program
Mateo, Calif., November 13, 2023 - Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT),
a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic
pathways, today reported financial results for the third quarter ended September 30, 2023, and provided recent corporate updates.
data generated to date reinforce our belief that denifanstat has the potential to treat patient populations in need across important
therapeutic indications including NASH, oncology, and acne. Denifanstat, as a once-daily, oral pill, offers a convenient and well-tolerated
potential treatment, particularly important for NASH, for which there are currently no approved treatments in the United
States or Europe," said Dave Happel, Chief Executive Officer of Sagimet. "The Sagimet team remains focused on delivering
week 52 topline results, including liver biopsy, from our Phase 2b FASCINATE-2 clinical trial in NASH in the first quarter of next year,
a crucial milestone in our clinical development of denifanstat."
Recent Corporate Highlights
Anticipated Upcoming Milestones
Financial Results for the Three Months
Ended September 30, 2023
About Sagimet Biosciences
is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors
that 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 NASH,
for which there are no treatments currently approved in the United States or Europe. Denifanstat is currently being tested in FASCINATE-2,
a Phase 2b clinical trial in NASH with liver biopsy as the primary endpoint. For additional information about Sagimet, please visit www.sagimet.com.
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, including its FASCINATE-2
Phase 2b clinical trial; 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.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
thousands, except for share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue: | ||||||||||||||||
| License revenue | $ | 2,000 | $ | - | $ | 2,000 | $ | - | ||||||||
| Total revenue | 2,000 | - | 2,000 | - | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 4,958 | $ | 6,838 | $ | 14,121 | $ | 19,072 | ||||||||
| General and administrative | 4,494 | 848 | 9,153 | 4,595 | ||||||||||||
| Total operating expenses | 9,452 | 7,686 | 23,274 | 23,667 | ||||||||||||
| Loss from operations | (7,452 | ) | (7,686 | ) | (21,274 | ) | (23,667 | ) | ||||||||
| Other income, net: | ||||||||||||||||
| Change in fair value of redeemable convertible preferred stock warrants | - | 1 | (1 | ) | 3 | |||||||||||
| Change in fair value of Series A common stock warrant | 4 | - | 4 | - | ||||||||||||
| Interest income and other | 1,095 | 218 | 1,546 | 360 | ||||||||||||
| Total other income, net | 1,099 | 219 | 1,549 | 363 | ||||||||||||
| Net loss | $ | (6,353 | ) | $ | (7,467 | ) | $ | (19,725 | ) | $ | (23,304 | ) | ||||
| Other comprehensive gain (loss): | ||||||||||||||||
| Net unrealized gain (loss) on investments in marketable securities | - | (56 | ) | 84 | (162 | ) | ||||||||||
| Total other comprehensive gain (loss) | - | (56 | ) | 84 | (162 | ) | ||||||||||
| Comprehensive loss | $ | (6,353 | ) | $ | (7,523 | ) | $ | (19,641 | ) | $ | (23,466 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | - | $ | (40.34 | ) | $ | - | $ | (126.13 | ) | ||||||
| Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted | - | 185,084 | - | 184,756 | ||||||||||||
| Net loss per share attributable to Series A and Series B common stockholders, basic and diluted | $ | (0.35 | ) | $ | - | $ | (3.22 | ) | $ | - | ||||||
| Weighted-average shares outstanding used in computing net loss per share attributable to | ||||||||||||||||
| Series A and Series B common stockholders, basic and diluted | 18,194,682 | - | 6,131,541 | - |
thousands, except for share and per share amounts)
| As of September 30, | As of December 31, | |||||||
| 2023 | 2022 | |||||||
| Cash, cash equivalents and short-term investments | $ | 101,842 | $ | 32,345 | ||||
| Total assets | 102,925 | 33,031 | ||||||
| Current liabilities | 5,049 | 5,279 | ||||||
| Noncurrent liabilities | 1 | 82 | ||||||
| Redeemable convertible preferred stock | - | 214,620 | ||||||
| Stockholders' equity (deficit) | 97,875 | (186,950 | ) | |||||
| Total liabilities, redeemable preferred stock and stockholders' equity (deficit) | $ | 102,925 | $ | 33,031 |