Sagimet Biosciences Reports Full Year 2023 Financial Results and Provides Corporate Updates
25 Março 2024 - 7:15AM
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 full
year ended December 31, 2023, and provided corporate updates.
"2023 was an outstanding year for Sagimet, as we
successfully transitioned to a public company and made significant
progress in further clinically validating the therapeutic potential
of denifanstat in patients living with MASH,” said David Happel,
Chief Executive Officer of Sagimet. "Denifanstat’s novel mechanism
of action targets the three key drivers of MASH, and we are pleased
that the topline results from our Phase 2b FASCINATE-2 clinical
trial met both primary efficacy endpoints and demonstrated a
statistically significant reduction in fibrosis. We look forward to
presenting the full data set at upcoming medical conferences later
this year and expect to initiate a pivotal Phase 3 trial for
denifanstat in MASH in the second half of 2024."
Full Year and Recent
Highlights
- In January 2024, Sagimet sold 9,000,000 shares of its Series A
common stock in an underwritten public offering and received $104.7
million in net proceeds. Proceeds from the offering, together with
its existing cash, cash equivalents and marketable securities will
be used (i) to advance the development of denifanstat and begin
startup activities related to the pivotal Phase 3 program in MASH,
formerly known as nonalcoholic steatohepatitis (NASH), including
manufacturing of additional drug supply, (ii) to advance the
development of TVB-3567 and submit an investigational new drug
application for a Phase 1 clinical trial for the treatment of acne
and (iii) for other general corporate purposes, including
additional clinical development, working capital and operating
expenses.
- In January 2024, Sagimet announced
positive topline results from the Phase 2b FASCINATE-2 clinical
trial, evaluating denifanstat in biopsy-confirmed MASH patients
with stage F2 or F3 fibrosis compared to placebo at week 52.
- The study met its primary efficacy
endpoints:
- MASH resolution without worsening of
fibrosis with ≥2-point reduction in NAS (NAFLD Activity Score) in
36% of denifanstat-treated patients vs 13% with placebo
(p=0.0022)
- ≥2-point reduction in NAS without
worsening of fibrosis in 52% of denifanstat-treated patients vs 20%
with placebo (p=0.0001)
- Multiple secondary endpoints were
met, achieving statistical significance, most notably fibrosis
improvement by ≥ 1 stage with no worsening of MASH in 41% of
denifanstat-treated patients vs 18% with
placebo (p=0.005).
- In November 2023, Sagimet presented
preclinical data evaluating denifanstat alone or in combination
with semaglutide in mouse models of MASH at the 7th Obesity and
NASH Drug Development Summit. The oral presentation highlighted
that the FASN inhibitor, alone, was responsible for significant
reduction of liver fibrosis. Additionally, the preclinical data
suggested the combination of the FASN inhibitor and semaglutide has
both an additive effect and provides support that distinct
mechanism of actions may provide therapeutic benefit to patients
with MASH.
- In October 2023, Sagimet’s license
partner for China, Ascletis Bioscience Co. Ltd. (Ascletis),
presented Phase 2 topline results at the European Academy of
Dermatology and Venereology (EADV) Congress 2023 in Berlin,
Germany. The presentation demonstrated denifanstat’s significant
efficacy in the change of total lesion and inflammatory lesion
count from baseline and was well-tolerated in patients with
acne.
- In July 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 net proceeds of approximately $86.2 million.
- In January 2024, Ascletis announced the dosing of the first
patient in its Phase 3 registration clinical trial of denifanstat
for the treatment of moderate to severe acne.
- In January 2024, Ascletis announced the dosing of the first
patient in its Phase 3 registration clinical trial of denifanstat
combined with bevacizumab for treatment of recurrent glioblastoma;
in September 2023, Ascletis announced enrollment of 120
patients in the trial, which it anticipates will provide sufficient
events for its planned interim analysis of progression-free
survival.
Anticipated Upcoming
Milestones
- The Phase 1 clinical trial results
characterizing the pharmacokinetic and tolerability profile of
denifanstat in patients with impaired hepatic function are
anticipated in the first quarter of 2024.
- Sagimet expects to hold an
End-of-Phase 2 meeting with the FDA in the first half of 2024, and
plans to initiate the pivotal Phase 3 clinical trial of denifanstat
in the second half of 2024.
- Sagimet has completed IND-enabling
studies for TVB-3567, a FASN inhibitor, and are evaluating the
timing to file an investigational new drug (IND) application for a
Phase 1 clinical trial evaluating TVB-3567 in acne.
Financial Results for the Year Ended December 31,
2023
- Cash, cash
equivalents and marketable securities for the year ended
December 31, 2023 were $94.9 million, and together with the $104.7
million in net proceeds from the January 2024 public offering, are
expected to fund operations for at least the next 12 months based
on management’s current operating plan.
-
Revenues for the year ended December 31, 2023 were
$2.0 million compared to no revenues for fiscal 2022. 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 year ended
December 31, 2023 was $19.8 million compared to $24.9 million for
the same period in 2022. The decrease in R&D expense was
primarily driven by a decrease in activities related to our
FASCINATE-2 clinical trial as we completed the trial in 2023 and
reported positive top-line data in January 2024.
- General and
administrative (G&A) expense for the year ended
December 31, 2023 was $13.0 million compared to $6.1 million for
the same period in 2022. The increase in G&A expense was
primarily driven by expenses related to operating as a public
company after completion of our IPO, including an increase in
headcount and non-cash stock-based
compensation.
- Net
loss for the year ended December 31, 2023 was $27.9
million compared to a net loss of $30.5 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
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.
About MASH
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.
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 3
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.STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(in thousands,
except for share and per share
amounts)(unaudited) |
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
License revenue |
|
$ |
2,000 |
|
|
$ |
— |
|
Total revenue |
|
|
2,000 |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
19,777 |
|
|
|
24,919 |
|
General and administrative |
|
|
12,963 |
|
|
|
6,136 |
|
Total operating expenses |
|
|
32,740 |
|
|
|
31,055 |
|
Loss from operations |
|
|
(30,740 |
) |
|
|
(31,055 |
) |
Other income, net: |
|
|
|
|
|
|
Change in fair value of stock warrant liability |
|
|
4 |
|
|
|
3 |
|
Interest income and other |
|
|
2,860 |
|
|
|
553 |
|
Total other income, net |
|
|
2,864 |
|
|
|
556 |
|
Net loss |
|
$ |
(27,876 |
) |
|
$ |
(30,499 |
) |
Other comprehensive gain
(loss): |
|
|
|
|
|
|
Net unrealized gain (loss) on marketable securities |
|
|
114 |
|
|
|
(84 |
) |
Total other comprehensive gain (loss) |
|
|
114 |
|
|
|
(84 |
) |
Comprehensive loss |
|
$ |
(27,762 |
) |
|
$ |
(30,583 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(2.66 |
) |
|
$ |
(165.20 |
) |
Weighted-average shares
outstanding used in computing net loss per share attributable to
common stockholders, basic and diluted |
|
|
10,460,335 |
|
|
|
184,619 |
|
SAGIMET BIOSCIENCES INC. |
BALANCE SHEETS |
(in thousands, except for share and per share
amounts)(unaudited) |
|
As of December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
Cash, cash equivalents and
marketable securities |
|
$ |
94,897 |
|
$ |
32,345 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
|
96,719 |
|
|
33,031 |
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
5,654 |
|
|
5,279 |
|
|
|
|
|
|
|
|
|
|
Noncurrent liabilities |
|
|
- |
|
|
82 |
|
|
|
|
|
|
|
|
|
|
Redeemable convertible
preferred stock |
|
|
- |
|
|
214,620 |
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficit) |
|
|
91,065 |
|
|
(186,950 |
) |
|
|
|
|
|
|
|
|
|
Total liabilities, redeemable
preferred stock and stockholders' equity (deficit) |
$ |
96,719 |
$ |
33,031 |
|
|
|
|
|
|
|
|
|
|
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