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Positive Phase 3 acne safety results highlighted by Sagimet (NASDAQ: SGMT)

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Sagimet Biosciences Inc. filed a current report describing new communications to investors about a key development in its partnered acne program. The company issued a press release noting that Ascletis Pharma reported positive topline results from an open-label Phase 3 trial evaluating the long-term safety of ASC40 (denifanstat) tablets in patients with moderate to severe acne.

Sagimet also refreshed its investor slide presentation, which will be used in future investor meetings. Both the press release and the updated presentation are furnished as exhibits and are not treated as filed financial statements under securities law.

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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): February 2, 2026

 

 

 

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 7.01 Regulation FD Disclosure.

 

On February 2, 2026, Sagimet Biosciences Inc. (the “Company”) issued a press release announcing that Ascletis Pharma Inc. announced on January 29th positive topline results in the open-label Phase 3 clinical trial evaluating the long-term safety of ASC40 (denifanstat) tablets in patients with moderate to severe acne. The full text of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Also on February 2, 2026, the Company updated information reflected in a slide presentation, which is attached as Exhibit 99.2 to this Current Report on Form 8-K, and is incorporated herein by reference. Representatives of the Company will use the updated presentation in various meetings with investors from time to time.

 

The information in Item 7.01 of this Current Report on Form 8-K, including the information set forth in Exhibits 99.1 and 99.2, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, nor shall Exhibits 99.1 or 99.2 furnished herewith be deemed incorporated by reference in any filing under the Securities Act 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

 

Exhibit 
No.
  Document
99.1   Press Release of Sagimet Biosciences Inc., dated February 2, 2026.
99.2   Investor Presentation of Sagimet Biosciences Inc., dated February 2, 2026.
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: February 2, 2026 By: /s/ David Happel
    David Happel
    Chief Executive Officer

 

 

 

FAQ

What did Sagimet Biosciences (SGMT) disclose in this 8-K filing?

Sagimet Biosciences reported that Ascletis Pharma announced positive topline results from an open-label Phase 3 trial of ASC40 (denifanstat) for moderate to severe acne. Sagimet also furnished an updated investor presentation it plans to use in future investor meetings.

What clinical trial update is mentioned for Sagimet Biosciences (SGMT)?

The filing notes Ascletis Pharma announced positive topline results from an open-label Phase 3 clinical trial evaluating long-term safety of ASC40 (denifanstat) tablets in patients with moderate to severe acne. These results were highlighted in a Sagimet press release furnished as an exhibit.

Which exhibits did Sagimet Biosciences (SGMT) include with this 8-K?

Sagimet attached a press release as Exhibit 99.1 and an updated investor presentation as Exhibit 99.2, both dated February 2, 2026. It also included the cover page interactive data file as Exhibit 104 embedded in the Inline XBRL document.

How will Sagimet Biosciences (SGMT) use the updated investor presentation?

The company states that representatives will use the updated slide presentation in various meetings with investors from time to time. The presentation, dated February 2, 2026, is furnished as Exhibit 99.2 and provides refreshed information for investor communications.

Are Sagimet’s press release and investor deck considered filed financial information?

No. Sagimet specifies that the information in Item 7.01, including Exhibits 99.1 and 99.2, is being furnished and not deemed filed for purposes of Section 18 of the Exchange Act or automatically incorporated into Securities Act or Exchange Act filings.

What is ASC40 (denifanstat) in Sagimet Biosciences’ 8-K disclosure?

ASC40, also called denifanstat, is described as an oral tablet evaluated in an open-label Phase 3 trial for long-term safety in moderate to severe acne. Ascletis Pharma reported positive topline results, which Sagimet highlighted through its furnished press release.
Sagimet Biosciences Inc.

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