Sagimet Biosciences Reports Second Quarter 2023 Financial Results and Provides Corporate Updates
21 Agosto 2023 - 5:02PM
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, 2023, and provided recent
corporate updates.
“Sagimet has entered a new era as a public company, and I am
proud of our team for the successful completion of our IPO and the
continued advancement of denifanstat through clinical development
in NASH,” said David Happel, Chief Executive Officer of Sagimet.
“At EASL, we presented statistically significant results from the
planned interim readout of the Phase 2b FASCINATE-2 trial of
denifanstat in NASH, and we look forward to announcing the week 52
biopsy results in the first quarter of next year.”
Recent Corporate Highlights
- On July 18, 2023, Sagimet closed an
upsized IPO of Series A common stock, at a public offering price of
$16.00 per share. Including shares issued pursuant to the exercise
of the underwriters’ option, the Company issued 6,026,772 shares of
Series A common stock, and received gross proceeds of approximately
$96.4 million before deducting underwriting discounts and
commissions and other offering expenses payable by Sagimet.
- In June, Sagimet presented planned
interim data at the EASL Congress showing that denifanstat was
well-tolerated and met the liver fat response endpoint in the Phase
2b FASCINATE-2 trial in biopsy confirmed F2-F3 NASH patients. 67%
of treated patients achieved ≥30% reductions in liver fat at week
26 compared to 18% for placebo (p<0.001) as assessed by
MRI-PDFF.
- In May 2023, Sagimet’s license
partner for China, Ascletis Bioscience, announced Phase 2 topline
results for denifanstat in acne vulgaris, reporting a statistically
significant 61.3% reduction in total lesion count in patients
treated with once daily, 50mg of denifanstat for 12 weeks, compared
to a 34.2% reduction with placebo. Ascletis reported a
statistically significant 65.0% reduction in inflammatory lesion
count at 50mg denifanstat compared to a 31.4% reduction with
placebo.
- In April, Sagimet appointed Tony
Rimac as Chief Operating Officer and Liz Rozek as General Counsel
& Chief Compliance Officer. In August, following the departure
of Dennis Hom, Mr. Rimac was appointed as Chief Financial
Officer.
Anticipated Upcoming Milestones
- The FASCINATE-2 Phase 2b clinical
trial for denifanstat in liver biopsy-confirmed F2-F3 NASH patients
is fully enrolled with biopsy results expected in the first quarter
of 2024.
- Sagimet expects to report Phase 1
clinical trial results that characterize the pharmacokinetic
profile of denifanstat in patients with impaired hepatic function
in the first quarter of 2024.
Financial Results for the Three Months Ended June 30,
2023
- Cash and cash equivalents for the second
quarter ended June 30, 2023 were $18.5 million as of June 30, 2023.
The subsequent IPO raised $86.2 million in net proceeds. Based on
its operating plan, management expects the combined cash balance to
fund operations into the first quarter of 2025.
- Research and development (R&D) expense for
the second quarter ended June 30, 2023 was $4.7 million compared to
$6.4 million for the second quarter of 2022. For the six months
ended June 30, 2023, R&D expense was $9.2 million compared to
$12.2 million for the same period in the prior year. The decrease
for both periods was primarily due to a decrease in clinical trial
costs for the FASCINATE-2 Phase 2b trial as patients progressed
through the trial.
- General and administrative (G&A) expense
for the second quarter ended June 30, 2023 was $2.4 million
compared to $0.9 million for the same period in 2022. G&A
expense for the six months ended June 30, 2023 was $4.7 million
compared to $3.7 million for the same period in the prior year. The
increase for both periods was primarily due to an increase in
stock-based compensation expense and professional services related
to Sagimet’s initial public offering.
- Net loss for the second quarter ended June 30,
2023 was $6.8 million compared to a net loss of $7.1 million for
the second quarter of 2022. The net loss for the six months ended
June 30, 2023 totaled $13.4 million compared to $15.8 million for
the same period in 2022.
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing
novel therapeutics called 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:
Robert UhlManaging Director, ICR
Westwicke858.356.5932robert.uhl@westwicke.com
|
SAGIMET BIOSCIENCES INC.CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited)(in
thousands, except
for share and
per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,676 |
|
|
$ |
6,371 |
|
|
$ |
9,163 |
|
|
$ |
12,234 |
|
|
General and administrative |
|
|
2,381 |
|
|
|
867 |
|
|
|
4,659 |
|
|
|
3,747 |
|
|
|
Total operating expenses |
|
|
7,057 |
|
|
|
7,238 |
|
|
|
13,822 |
|
|
|
15,981 |
|
|
|
Loss from operations |
|
|
(7,057 |
) |
|
|
(7,238 |
) |
|
|
(13,822 |
) |
|
|
(15,981 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
Change in fair value of redeemable convertible preferred stock
warrants |
|
|
1 |
|
|
|
- |
|
|
|
(1 |
) |
|
|
2 |
|
|
Interest income and other |
|
|
271 |
|
|
|
136 |
|
|
|
451 |
|
|
|
142 |
|
|
|
Total other income, net |
|
|
272 |
|
|
|
136 |
|
|
|
450 |
|
|
|
144 |
|
Net loss |
|
$ |
(6,785 |
) |
|
$ |
(7,102 |
) |
|
$ |
(13,372 |
) |
|
$ |
(15,837 |
) |
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(6,772 |
) |
|
$ |
(7,208 |
) |
|
$ |
(13,288 |
) |
|
$ |
(15,943 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
|
$ |
(35.80 |
) |
|
$ |
(38.37 |
) |
|
$ |
(71.39 |
) |
|
$ |
(85.80 |
) |
Weighted-average shares outstanding used in computing net loss per
share attributable to common stockholders, basic and diluted |
|
|
189,520 |
|
|
|
185,084 |
|
|
|
187,314 |
|
|
|
184,589 |
|
|
|
|
|
|
|
|
|
|
|
|
|
SAGIMET BIOSCIENCES INC. CONDENSED BALANCE
SHEETS(Unaudited)(in thousands,
except for share and per share amounts) |
|
|
|
|
|
As of June 30, |
|
As of December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Cash, cash equivalents and short-term investments |
|
$ |
18,508 |
|
|
$ |
32,345 |
|
|
|
|
|
|
Total assets |
|
|
21,498 |
|
|
|
33,031 |
|
|
|
|
|
|
Current liabilities |
|
|
5,287 |
|
|
|
5,279 |
|
|
|
|
|
|
Noncurrent liabilities |
|
|
5 |
|
|
|
82 |
|
|
|
|
|
|
Redeemable convertible preferred stock |
|
|
214,620 |
|
|
|
214,620 |
|
|
|
|
|
|
Stockholders' deficit |
|
|
(198,414 |
) |
|
|
(186,950 |
) |
|
|
|
|
|
Total liabilities, redeemable preferred stock and stockholders'
deficit |
|
$ |
21,498 |
|
|
$ |
33,031 |
|
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