0001104659-23-116795.txt : 20231113 0001104659-23-116795.hdr.sgml : 20231113 20231113084012 ACCESSION NUMBER: 0001104659-23-116795 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20231113 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231113 DATE AS OF CHANGE: 20231113 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Sagimet Biosciences Inc. CENTRAL INDEX KEY: 0001400118 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] 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: 231395469 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 tm2330502d1_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): 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 2.02Results 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 9.01Financial Statements and Exhibits

 

(d) Exhibits

     

Exhibit

No.

   Document  
       
99.1   Press Release of Sagimet Biosciences Inc., dated November 13, 2023.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

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

 

 

 EX-99.1 2 tm2330502d1_ex99-1.htm EXHIBIT 99.1

 

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.

oAn 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.

 

 

 

 

oAn 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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Cover
Nov. 13, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 13, 2023
Entity File Number 001-41742
Entity Registrant Name SAGIMET BIOSCIENCES INC.
Entity Central Index Key 0001400118
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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