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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
November 13, 2023
SAGIMET BIOSCIENCES INC.
(Exact name of registrant as specified in its
charter)
Delaware |
001-41742 |
20-5991472 |
(State or other jurisdiction
of incorporation) |
(Commission
File Number) |
(I.R.S. Employer
Identification No.) |
Sagimet Biosciences Inc.
155 Bovet Road, Suite 303,
San Mateo, California 94402
(Address of principal executive offices, including
zip code)
(650) 561-8600
(Registrant’s telephone number, including
area code)
Not Applicable
(Former Name or Former Address, if Changed Since
Last Report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant
to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trade
Symbol(s) |
Name of each exchange on which registered |
Series A Common Stock, $0.0001 par value per share |
SGMT |
The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging
growth company x
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
| Item 2.02 | Results of Operations and Financial Condition |
On November 13,
2023, Sagimet Biosciences Inc. (the “Company”) issued a press release announcing its financial results for the third quarter
ended September 30, 2023. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and
is incorporated herein by reference.
The information
in Item 2.02 of this Current Report on Form 8-K, including the information set forth in Exhibit 99.1, is being furnished and
shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), nor shall Exhibit 99.1 filed herewith be deemed incorporated by reference in any filing under the Securities Act of
1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
Sagimet Biosciences Inc. |
|
|
|
Date: November 13, 2023 |
By: |
/s/ David Happel |
|
|
David Happel |
|
|
Chief Executive Officer |
Exhibit 99.1
Sagimet Biosciences
Reports Third Quarter 2023 Financial Results and Provides Corporate Updates
On track to report
topline week 52 liver biopsy results from Phase 2b FASCINATE-2 trial with denifanstat in the first quarter of 2024
Two abstracts,
including late-breaker, accepted at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting®
2023
Enrollment of
120 patients in Phase 3 registrational trial of denifanstat in recurrent glioblastoma (GBM) announced by license partner, Ascletis
Presentation
of positive topline Phase 2 denifanstat monotherapy data from Ascletis’ acne program
San
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.
“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. |
| o | 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. |
| o | 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 Yonkoski
ICR Westwicke
203-682-7167
maria.yonkoski@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 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 | | |
| - | |
SAGIMET
BIOSCIENCES INC.
CONDENSED
BALANCE SHEETS
(Unaudited)
(in
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 | |
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Sagiment Biosciences (NASDAQ:SGMT)
過去 株価チャート
から 5 2024 まで 6 2024
Sagiment Biosciences (NASDAQ:SGMT)
過去 株価チャート
から 6 2023 まで 6 2024