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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):
May 12, 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
2.02 | Results
of Operations and Financial Condition. |
On May 12, 2026, Sagimet Biosciences Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026. A copy of the
press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in this Item 2.02
(including 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”), or otherwise subject to the liabilities of that section and shall not be deemed
to be 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 filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| |
|
|
Exhibit
No. |
|
Document |
| 99.1 |
|
Press Release of Sagimet Biosciences Inc., dated May 12, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
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: May 12, 2026 |
By: |
/s/ David Happel |
| |
|
David Happel |
| |
|
Chief Executive Officer |
Exhibit 99.1
Sagimet Biosciences
Reports First Quarter 2026 Financial Results and Provides Corporate Updates
Secured equity
financing with gross proceeds of $175M in April 2026
Phase 3 clinical
trial of denifanstat in moderate to severe acne patients for the U.S.
planned
to initiate in second half of 2026
First-in-human
Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing
Cumulative cash,
cash equivalents and marketable securities expected to fund current operations through 2028, including through data readout of denifanstat
Phase 3 trial in moderate to severe acne
San
Mateo, Calif., May 12, 2026 – Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage
biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial
results for the quarter ended March 31, 2026, and provided corporate updates.
“Our recent strategic decision
to focus on dermatology marks a turning point for Sagimet, and we are excited about the path ahead. In the near term, we are targeting
the second half of 2026 to initiate a Phase 3 clinical trial of denifanstat in moderate to severe acne in the U.S. We believe that denifanstat,
with its differentiated mode of action, could potentially offer a convenient oral once-daily treatment option for those living
with moderate to severe acne. The clinical community caring for patients with acne has waited more than 40 years for an innovative oral
treatment,” said David Happel, Chief Executive Officer of Sagimet. “We recently strengthened Sagimet’s ability
to move forward with its innovative dermatology programs with the completion of a $175 million equity financing. Combined with our existing
cash balance, we are well capitalized to fund our programs through 2028 including data readout of our planned denifanstat Phase 3 clinical
trial in moderate to severe acne.”
Recent
Corporate Highlights
| · | The Company recently completed an underwritten offering of 29,166,700 shares of its Series A common stock
at a price of $6.00 per share, resulting in $175.0 million gross proceeds, before deducting underwriting discounts and commissions and
other offering expenses. |
| o | The financing included participation from new and existing investors,
including Balyasny Asset Management, Blue Owl Healthcare Opportunities, BVF Partners L.P., Caligan Partners, Coastlands Capital, Farallon
Capital Management, Great Point Partners, LLC, Woodline Partners LP and a large mutual fund. |
| o | The Company currently expects that its existing cash and cash
equivalents, together with the proceeds from the offering, will fund its acne programs through 2028 and the data readout of the Company’s
planned denifanstat Phase 3 clinical trial in moderate to severe acne. |
| · | A first-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 is ongoing. |
| · | The Company held a key opinion leader (KOL) event and webcast on April 30 (link here) featuring Julie Harper, MD (Founding Director
and past President of the American Acne and Rosacea Society). In the webcast, Dr. Harper discussed the current acne treatment landscape
and the unmet need for additional treatment options for moderate to severe acne. Management also discussed the planned Phase 3 clinical
trial of denifanstat in moderate to severe acne for the U.S., expected to begin in the second half of 2026. |
Publications and Presentations
| · | Data showing that Sagimet’s FASN inhibitors reduced de novo lipid levels (DNL) in human sebocytes will be discussed in a poster
presentation at the 83rd Society for Investigative Dermatology Annual Meeting in Chicago on May 15, 2026. |
Anticipated Upcoming Milestones
| · | Sagimet plans to initiate a Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. in the second half
of 2026, subject to Investigational New Drug (IND) clearance. |
| · | Upon completion of the Phase 1 clinical trial of TVB-3567, subject to consultation with regulatory authorities, Sagimet plans to initiate
a Phase 2 clinical trial with TVB-3567 in moderate to severe acne patients in the second half of 2026. |
| · | The Company also plans to develop a topical formulation of a FASN inhibitor for the potential treatment of acne. |
Financial Results for the Three Months Ended March 31, 2026
| · | Cash, cash equivalents and marketable securities as of March 31, 2026, were $104.5 million. |
| · | Research and development expense for the quarter ended March 31, 2026, was $7.0 million compared to $15.3 million for
the first quarter of 2025. |
| · | General and administrative expense for the quarter ended March 31, 2026, was $4.7 million, compared to $4.5 million
for the first quarter of 2025. |
| · | Net loss for the quarter ended March 31, 2026, was $10.7 million compared to $18.2 million for the first quarter
of 2025. |
About Sagimet Biosciences
Sagimet
is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic
pathways in conditions resulting from the overproduction of the fatty acid, palmitate. FASN is a regulator of lipid synthesis, and a
key pathway implicated in multiple diseases, such as acne, MASH and certain FASN-dependent tumor types. For additional information
about Sagimet, please visit www.sagimet.com.
About Acne
Acne is one of the most common skin conditions in the U.S., with approximately
50 million Americans affected annually and more than 5 million seeking medical treatment for acne each year. Acne affects around 85% of
persons between the ages of 12 and 24. Moderate to severe acne accounts for 20% of acne sufferers, or approximately 10 million people
in the U.S. annually. There is no cure for acne; and due to its pathology, most patients require chronic management and multiple annual
courses of treatment for flare control.
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 timelines and anticipated development milestones, are forward-looking statements. 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,
TVB-3567 or any other drug candidates or combination therapies developed by Sagimet; Sagimet’s ability to advance drug candidates
into and successfully complete clinical trials within anticipated timelines; 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.
Investor Contact:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
Media Contact:
Maggie Whitney
LifeSci Communications
mwhitney@lifescicomms.com
SAGIMET
BIOSCIENCES INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands, except for share and per share amounts)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Operating expenses: | |
| | | |
| | |
| Research and development | |
| 6,995 | | |
| 15,342 | |
| General and administrative | |
| 4,718 | | |
| 4,523 | |
| Total operating expenses | |
| 11,713 | | |
| 19,865 | |
| Loss from operations | |
| (11,713 | ) | |
| (19,865 | ) |
| Total other income | |
| 1,063 | | |
| 1,689 | |
| Net loss | |
$ | (10,650 | ) | |
$ | (18,176 | ) |
| | |
| | | |
| | |
| Net loss per share, basic and diluted | |
$ | (0.33 | ) | |
$ | (0.56 | ) |
| Weighted-average shares outstanding, basic and diluted | |
| 32,559,704 | | |
| 32,195,345 | |
| | |
| | | |
| | |
| Net loss | |
$ | (10,650 | ) | |
$ | (18,176 | ) |
| Other comprehensive loss: | |
| | | |
| | |
| Net unrealized loss on marketable securities | |
| (112 | ) | |
| (109 | ) |
| Total comprehensive loss | |
$ | (10,762 | ) | |
$ | (18,285 | ) |
SAGIMET
BIOSCIENCES INC.
CONDENSED BALANCE SHEETS
(unaudited)
(in thousands)
| | |
As of | |
| | |
March 31, 2026 | | |
December 31, 2025 | |
| Cash, cash equivalents and marketable securities | |
$ | 104,539 | | |
$ | 113,124 | |
| Total assets | |
$ | 107,755 | | |
$ | 116,482 | |
| Current liabilties | |
$ | 5,297 | | |
$ | 5,101 | |
| Stockholders' equity | |
$ | 102,458 | | |
$ | 111,381 | |
| Liabilities and stockholders' equity | |
$ | 107,755 | | |
$ | 116,482 | |