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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):
June 5, 2024
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 5.07 |
Submission of Matters to a Vote of Security Holders. |
On June 5,
2024, Sagimet Biosciences Inc. (the “Company”) held its 2024 Annual Meeting of Stockholders (the “Annual Meeting”).
As of April 10, 2024, the record date for the Annual Meeting, there were 30,394,655 outstanding shares of the Company’s common stock.
The Annual Meeting was conducted virtually, and the following is a brief description of the final voting results for each of the proposals
submitted to a vote of the stockholders at the Annual Meeting, which are described in detail in the Company’s definitive proxy statement
for the Annual Meeting, filed with the U.S. Securities and Exchange Commission on April 18, 2024.
(a) Proposal 1 - Election of Class I Directors. Each of
Paul Hoelscher and Timothy P. Walbert were elected to the Board to serve as Class I directors until the 2027 Annual Meeting of Stockholders
and until their successors, if any, are elected or appointed, or their earlier death, resignation, retirement, disqualification or removal,
as follows:
| Name | |
For | | |
Withheld | | |
Broker Non-Votes | |
| Paul Hoelscher | |
17,078,342 | | |
89,926 | | |
6,800,117 | |
| Timothy P. Walbert | |
17,078,717 | | |
89,551 | | |
6,800,117 | |
(b) Proposal 2 - Ratification of Independent Registered Public
Accountant. The appointment of Deloitte & Touche LLP as the Company’s independent registered public accounting firm for
the 2024 fiscal year was ratified, as follows:
| For | |
Against | | |
Abstentions | | |
Broker Non-Votes | |
| 23,938,535 | |
18,346 | | |
11,504 | | |
0 | |
On June 6, 2024, the Company presented positive data from its
FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed metabolic dysfunction-associated
steatohepatitis (MASH) patients at the European Association for the Study of the Liver (EASL) Congress 2024 being held in Milan,
Italy. A copy of this press release is attached as Exhibit 99.1 to this Current
Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
Sagimet Biosciences Inc. |
| |
|
|
| Date: June 6, 2024 |
By: |
/s/ David Happel |
| |
|
David Happel |
| |
|
Chief Executive Officer |
Exhibit
99.1
Sagimet
Biosciences Presents Data from ITT and F3 Patient Population in Phase
2b FASCINATE-2 Clinical Trial of Denifanstat at EASL International
Liver Congress 2024
Denifanstat
achieved statistically significant results on primary and secondary liver biopsy endpoints in the
ITT population, including both histology
endpoints recommended in the FDA draft guidance for accelerated approval in MASH
Denifanstat
showed a statistically significant improvement in liver fibrosis ≥1-stage without worsening of
MASH in the ITT population, including
in patients with baseline stage 3 fibrosis
Statistical
significance also shown in improvement of liver fibrosis ≥2-stage without worsening of MASH in
the mITT population, including in patients
with baseline stage 3 fibrosis
Tripalmitin,
a biomarker of denifanstat activity, showed an early and sustained reduction in de novo
lipogenesis at 4-weeks
Safety
in the ITT population showed denifanstat was generally well tolerated
Management
to host live webcast with Principal Investigator Dr. Rohit Loomba at 9:30 AM PT (12:30 PM ET)
on Thursday, June 13, 2023
SAN
MATEO, Calif., June 6, 2024 (GLOBE NEWSWIRE) -- 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, presented
positive data from its FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed metabolic dysfunction-associated
steatohepatitis (MASH) patients at the European Association for the Study of the Liver (EASL) Congress being held in Milan, Italy. Sagimet’s
lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of MASH.
“Our
presentation of the FASCINATE-2 study data shows the strong impact of denifanstat, a novel therapeutic designed to reduce the three main
drivers of MASH - fat accumulation, inflammation, and fibrosis. The week 52 data on the improvement of fibrosis both by ≥ 1 and ≥
2 stages, particularly in the F3 patient population, are very encouraging and differentiate denifanstat,” said Dave Happel, Chief
Executive Officer of Sagimet. “Our focus now shifts to initiating our Phase 3 registrational program for the development of denifanstat
in MASH with fibrosis in the second half of this year.”
Positive
top line data was announced for the FASCINATE-2 Phase 2b study on January 22, 2024 (here). In the EASL presentation, additional
52-week ITT and F3 subgroup efficacy data included:
| · | The
primary endpoint of ≥2-point reduction in NAS (NAFLD Activity Score) without worsening
of fibrosis (16% placebo vs 38% with denifanstat, p=0.0035) or MASH resolution with ≥2-point
reduction in NAS resolution without worsening of fibrosis (11% placebo vs 26% with denifanstat,
p=0.0173) in the intention to treat (ITT) population. |
| · | Secondary
endpoints of fibrosis improvement by ≥ 1 stage with no worsening of MASH in the ITT (14%
placebo vs 30% with denifanstat, p=0.0199) and F3 (13% placebo vs 49% with denifanstat, p=0.0032)
populations, and fibrosis improvement by ≥ 2 stages with no worsening of MASH in the mITT
(2% placebo vs 20% with denifanstat, p=0.0065) and F3 (4% placebo vs 34% with denifanstat,
p=0.0050) populations. |
| · | Data
on significant increase in beneficial polyunsaturated triglycerides at the end of 52 week
of treatment (-4% placebo vs +42% denifanstat, p<0.001) in the mITT population. |
| · | A
biomarker of denifanstat activity (tripalmitin) showed an early and sustained reduction in
de novo lipogenesis at 4-weeks (-0.4ug/mL placebo vs -2.4ug/ml with denifanstat, p=0.001)
and 13-weeks (-0.1ug/mL placebo vs -2.1ug/mL with denifanstat, p=0.005) in the mITT population. |
“Denifanstat
is the only FASN inhibitor currently in clinical development for MASH,” commented Rohit Loomba, M.D., M.H.Sc., Professor of Medicine,
Chief, Division of Gastroenterology and Hepatology, and Director, MASLD Research Center, University of California San Diego, who serves
as a scientific advisor for Sagimet on its ongoing development of denifanstat. “After one year of treatment, denifanstat was significantly
better than placebo for both MASH resolution without worsening of fibrosis as well as 1 stage or greater improvements in fibrosis stage.
As an oral small molecule, denifanstat shows robust improvements in patients with F3 fibrosis which supports its continued development
in patients with moderate to advanced fibrosis due to MASH.”
Endpoints
and Improvements From FASCINATE-2 Reported at EASL 2024
| |
Patient
Population |
Denifanstat
50 mg |
Placebo |
P-value
vs placebo |
| Primary
Endpoints |
MASH
resolution without worsening of fibrosis with ≥2-point reduction in NAS |
ITT |
38% |
16% |
0.0035 |
≥
2-point decrease in NAS without worsening of fibrosis |
ITT |
26% |
11% |
0.0173 |
| Other
Endpoints |
Improvement
of fibrosis by ≥ 1 stage with no worsening of MASH |
ITT |
30% |
14% |
0.019 |
| mITT-
F3 |
49% |
13% |
0.0032 |
Improvement
of fibrosis by ≥ 2 stage with no worsening of MASH |
mITT |
20% |
2% |
0.0065 |
| mITT-
F3 |
34% |
4% |
0.0050 |
| Polyunsaturated
Triglycerides |
mITT |
+42% |
-4% |
<0.001 |
| Tripalmitin* |
mITT |
-2.1ug/mL |
-0.1ug/mL |
0.005 |
Modified
intent-to-treat population (mITT) includes all patients with paired biopsies, n=81 denifanstat, n=45 placebo; ITT population: n =112
denifanstat, n=56 placebo.
*52-week
timepoint
Safety
and Tolerability
As
in prior studies, no treatment-related serious adverse events (SAEs) were observed, and the majority of adverse events (AEs) were mild
to moderate in nature (Grades 1 and 2). There were no Grade ≥3 treatment-related AEs, and no drug-induced liver injury (DILI) signal
in the study. The most common treatment-related AEs by system organ class (observed in ≥5% of patients in the study) were eye disorders
(denifanstat 15.2%, placebo 16.1%), gastrointestinal disorders (denifanstat 11.6%, placebo 8.9%), and skin and subcutaneous tissue disorders
(denifanstat 22.3%, placebo 7.1%). The incidence of treatment emergent adverse events (TEAEs) leading to treatment discontinuation was
19.6% in the denifanstat group compared to 5.4% in placebo.
Webcast
Information
Management
will host a live webcast with Principal Investigator Dr. Rohit Loomba at 9:30 AM PT (12:30 PM ET) on Thursday, June 13, 2024 to discuss
the data; participants will have the opportunity to participate in a chat-based Q&A session. The webcast will be available in the
Events & Presentation section of Sagimet’s website at www.sagimet.com, with an archived replay available for approximately
90 days following the event. Dr. Loomba’s full curriculum vitae (CV) and disclosure of conflicts of interest (COI) can be found
in the EASL presentation which is available in the Posters & Publications section of Sagimet’s website at www.sagimet.com.
About
the Phase 2b FASCINATE-2 Clinical Trial
The
Phase 2b FASCINATE-2 clinical trial was a 52-week randomized, double-blind, placebo-controlled trial that evaluated the safety and histological
impact of denifanstat compared to placebo in 168 biopsy-confirmed MASH patients with moderate-to-severe fibrosis (stage F2 or F3) with
NAS ≥4. Patients were randomized 2:1 to receive 50 mg denifanstat or placebo, taken orally once daily. An end-of-trial biopsy was
assessed by a central pathologist for histological endpoints. Liver biopsies were also analyzed using AI-based digital pathology.
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.
Joyce Allaire
LifeSci Advisors
JAllaire@lifesciadvisors.com
v3.24.1.1.u2
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