Sagimet Biosciences Reports Third Quarter 2023 Financial Results and Provides Corporate Updates
13 Novembre 2023 - 2:00PM
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.
“The 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
- Two abstracts were accepted at the
AASLD – The Liver Meeting® 2023, held on November 10-14, in Boston,
MA.
- An abstract detailing preclinical
data from a mouse model of diet induced NASH highlighted that the
combination of Sagimet’s FASN inhibitor and semaglutide reduced
body weight and showed further histological improvement on liver
pathology, including NAFLD activity score and fibrosis compared to
single agent treatment.
- An interim analysis of FASCINATE-2,
a Phase 2b randomized, placebo-controlled trial, demonstrated
denifanstat’s reduction of circulating saturated diacylglycerols
and triacylglycerols, markers of lipotoxicity.
- In October, Sagimet’s license
partner for China, Ascletis Bioscience Co. Ltd. (Ascletis),
presented Phase 2 topline results of denifanstat in patients with
acne at the European Academy of Dermatology and Venereology (EADV)
Congress 2023 in Berlin, Germany showing that denifanstat
demonstrated significant efficacy in the change of total lesion and
inflammatory lesion count from baseline and was
well-tolerated.
- In September, Ascletis announced
enrollment of 120 patients in its Phase 3 registration clinical
trial of denifanstat combined with bevacizumab for treatment of
recurrent GBM, which it anticipates will provide sufficient events
for its planned interim analysis of progression-free survival.
Anticipated Upcoming Milestones
- The FASCINATE-2 Phase 2b clinical
trial of denifanstat in liver biopsy-confirmed F2-F3 NASH patients
is fully enrolled and week 52 topline results, including liver
biopsy, are expected in the first quarter of 2024.
- Sagimet expects to report Phase 1
clinical trial results characterizing the pharmacokinetic and
safety profile of denifanstat in patients with impaired hepatic
function in the first quarter of 2024.
Financial Results for the Three Months Ended September
30, 2023
- Cash and cash equivalents for the third
quarter ended September 30, 2023 were $101.8 million, expected to
fund operations for at least the next 12 months based on
management’s current operating plan.
- Revenues for the third quarter ended September
30, 2023 were $2.0 million compared to no revenues for the third
quarter of 2022. For the nine months ended September 23, 2023,
Revenues were $2.0 million compared to no revenues for the same
period in the prior year. The increase was due to a $2.0 million
milestone payment that was recognized in July 2023.
- Research and development (R&D) expense for
the third quarter ended September 30, 2023 was $5.0 million
compared to $6.8 million for the third quarter of 2022. For the
nine months ended September 30, 2023, R&D expense was $14.1
million compared to $19.1 million for the same period in the prior
year. The decrease in R&D expense was primarily driven by a
decrease in activities related to our FASCINATE-2 clinical trial as
patients progressed through the trial.
- General and administrative (G&A) expense
for the third quarter ended September 30, 2023 was $4.5 million
compared to $0.8 million for the same period in 2022. G&A
expense for the nine months ended September 30, 2023 was $9.2
million compared to $4.6 million for the same period in the prior
year. The increase in G&A expense was primarily driven by
expenses related to operating as a public company after completion
of its IPO, including an increase in headcount and non-cash
stock-based compensation.
- Net loss for the third quarter ended September
30, 2023 was $6.4 million compared to a net loss of $7.5 million
for the third quarter of 2022. The net loss for the nine months
ended September 30, 2023 totaled $19.7 million compared to $23.3
million for the same period in 2022.
About Sagimet Biosciences
Sagimet 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.
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 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.
Contact:
Maria YonkoskiICR
Westwicke203-682-7167maria.yonkoski@westwicke.com
SAGIMET BIOSCIENCES INC. |
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CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
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(Unaudited) |
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(in thousands, except for share and per share
amounts) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenue: |
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License revenue |
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$ |
2,000 |
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$ |
- |
|
|
$ |
2,000 |
|
|
$ |
- |
|
Total revenue |
|
|
2,000 |
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|
|
- |
|
|
|
2,000 |
|
|
|
- |
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Operating expenses: |
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Research and development |
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$ |
4,958 |
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$ |
6,838 |
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$ |
14,121 |
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$ |
19,072 |
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|
General and administrative |
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4,494 |
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|
|
848 |
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9,153 |
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4,595 |
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Total operating expenses |
|
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9,452 |
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7,686 |
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|
23,274 |
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|
23,667 |
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Loss from operations |
|
|
(7,452 |
) |
|
|
(7,686 |
) |
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|
(21,274 |
) |
|
|
(23,667 |
) |
Other income, net: |
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Change in fair value of redeemable convertible preferred stock
warrants |
|
|
- |
|
|
|
1 |
|
|
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(1 |
) |
|
|
3 |
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Change in fair value of Series A common stock warrant |
|
|
4 |
|
|
|
- |
|
|
|
4 |
|
|
|
- |
|
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Interest income and other |
|
|
1,095 |
|
|
|
218 |
|
|
|
1,546 |
|
|
|
360 |
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Total other income, net |
|
|
1,099 |
|
|
|
219 |
|
|
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1,549 |
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|
|
363 |
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Net loss |
|
$ |
(6,353 |
) |
|
$ |
(7,467 |
) |
|
$ |
(19,725 |
) |
|
$ |
(23,304 |
) |
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Other comprehensive gain (loss): |
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Net unrealized gain (loss) on investments in marketable
securities |
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- |
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(56 |
) |
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|
84 |
|
|
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(162 |
) |
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Total other comprehensive gain (loss) |
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- |
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(56 |
) |
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84 |
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(162 |
) |
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Comprehensive loss |
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$ |
(6,353 |
) |
|
$ |
(7,523 |
) |
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$ |
(19,641 |
) |
|
$ |
(23,466 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
|
$ |
- |
|
|
$ |
(40.34 |
) |
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$ |
- |
|
|
$ |
(126.13 |
) |
Weighted-average shares outstanding used in computing net loss per
share attributable to common stockholders, basic and diluted |
|
|
- |
|
|
|
185,084 |
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|
|
- |
|
|
|
184,756 |
|
|
|
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|
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Net loss per share attributable to Series A and Series B common
stockholders, basic and diluted |
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$ |
(0.35 |
) |
|
$ |
- |
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$ |
(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 |
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|
|
- |
|
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6,131,541 |
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|
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- |
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SAGIMET BIOSCIENCES INC. |
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CONDENSED BALANCE SHEETS |
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(Unaudited) |
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(in thousands, except for share and per share
amounts) |
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As of September 30, |
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As of December 31, |
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2023 |
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2022 |
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Cash, cash equivalents and short-term investments |
|
$ |
101,842 |
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$ |
32,345 |
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Total assets |
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102,925 |
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|
|
33,031 |
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Current liabilities |
|
|
5,049 |
|
|
|
5,279 |
|
|
|
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Noncurrent liabilities |
|
|
1 |
|
|
|
82 |
|
|
|
|
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Redeemable convertible preferred stock |
|
|
- |
|
|
|
214,620 |
|
|
|
|
|
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Stockholders' equity (deficit) |
|
|
97,875 |
|
|
|
(186,950 |
) |
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|
Total liabilities, redeemable preferred stock and stockholders'
equity (deficit) |
|
$ |
102,925 |
|
|
$ |
33,031 |
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Grafico Azioni Sagiment Biosciences (NASDAQ:SGMT)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Sagiment Biosciences (NASDAQ:SGMT)
Storico
Da Set 2023 a Set 2024