0001104659-24-068817.txt : 20240606 0001104659-24-068817.hdr.sgml : 20240606 20240606060358 ACCESSION NUMBER: 0001104659-24-068817 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240605 ITEM INFORMATION: Submission of Matters to a Vote of Security Holders ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240606 DATE AS OF CHANGE: 20240606 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Sagimet Biosciences Inc. CENTRAL INDEX KEY: 0001400118 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 205991472 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-41742 FILM NUMBER: 241023779 BUSINESS ADDRESS: STREET 1: 155 BOVET RD., SUITE 303 CITY: SAN MATEO STATE: CA ZIP: 94402 BUSINESS PHONE: (650) 561-8600 MAIL ADDRESS: STREET 1: 155 BOVET RD., SUITE 303 CITY: SAN MATEO STATE: CA ZIP: 94402 FORMER COMPANY: FORMER CONFORMED NAME: 3-V Biosciences, Inc. DATE OF NAME CHANGE: 20070521 8-K 1 tm2416614d1_8k.htm FORM 8-K
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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 

 

Item 8.01 Other Events.

 

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

 

Exhibit No.   Document
     
99.1   Press Release of Sagimet Biosciences Inc., dated June 6, 2024.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

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

 

 

 

 EX-99.1 2 tm2416614d1_ex99-1.htm EXHIBIT 99.1

 

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.

 

Contact:

Joyce Allaire 

LifeSci Advisors 

JAllaire@lifesciadvisors.com

 

 

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Entity Tax Identification Number 20-5991472
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 155 Bovet Road
Entity Address, Address Line Two Suite 303
Entity Address, City or Town San Mateo
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94402
City Area Code 650
Local Phone Number 561-8600
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Series A Common Stock, $0.0001 par value per share
Trading Symbol SGMT
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
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