Sagimet Biosciences Inc. Form 10-Q Quarterly Report Filed 2025-05-08

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q


(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2025

OR

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

	For the transition period from to

Commission File Number: 001-41742

Sagimet Biosciences Inc.

(Exact name of registrant as specified in its charter)


Delaware	20-5991472
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

155 Bovet Road, Suite 303
San Mateo, California	94402
(Address of principal executive offices)	(Zip Code)

(650) 561-8600

(Registrant’s telephone number, including area code)

N/A

(Former name, former address and former fiscal year, if changed since last report)


Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Series A Common Stock, $0.0001 par value per share	SGMT	Nasdaq Global Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒

No☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ◻

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer ☐	Accelerated filer ☐

Non-accelerated filer ☒	Smaller reporting company ☒

	Emerging growth company ☒

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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The number of shares of the registrant’s Series A and B common stock, $0.0001 par value per share, outstanding at May 2, 2025 was 30,674,855 and 1,520,490, respectively.

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	PART I - FINANCIAL INFORMATION	Page

Item 1.	Condensed Financial Statements	5
	Condensed Balance Sheets (unaudited)	5
	Condensed Statements of Operations and Comprehensive Loss (unaudited)	6
	Condensed Statements of Stockholders’ Equity (unaudited)	7
	Condensed Statements of Cash Flows (unaudited)	8
	Notes to Condensed Financial Statements (unaudited)	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	26

	PART II - OTHER INFORMATION

Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	27
Item 3.	Defaults Upon Senior Securities	27
Item 4.	Mine Safety Disclosures	28
Item 5.	Other Information	28
Item 6.	Exhibits	29
	Signatures	30

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FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (this Quarterly Report) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, drug candidates, planned preclinical studies and clinical trials, results of preclinical studies, clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our 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, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:

●

our financial performance;

●

our ability to obtain additional cash and the sufficiency of our existing cash, cash equivalents and marketable securities to fund our future operating expenses and capital expenditure requirements;

●

the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing;

●

the scope, progress, results and costs of developing denifanstat or any other drug candidates we may develop, and conducting preclinical studies and clinical trials;

●

our ability to advance drug candidates into, and successfully complete, clinical trials within anticipated timelines;

●

the timing and costs involved in obtaining and maintaining regulatory approval of denifanstat or any other drug candidates we may develop, and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations or accelerated approvals for our drug candidates for various indications;

●

current and future agreements with third parties in connection with the development and commercialization of denifanstat or any other future drug candidate;

●

our estimate of the number of patients in the United States who suffer from the diseases we target and the number of subjects that will enroll in our clinical trials;

●

our relationship with Ascletis BioScience Co. Ltd. (Ascletis), and its affiliate Gannex Pharma Co., Ltd. (Gannex), and the success of their development efforts for denifanstat;

●

the ability of our clinical trials to demonstrate the safety and efficacy of denifanstat and any other drug candidates we may develop;

●

our plans relating to commercializing denifanstat and any other drug candidates we may develop, if approved, including the geographic areas of focus and our ability to grow a sales team;

●

the success of competing therapies that are or may become available;

●

developments relating to our competitors and our industry, including competing drug candidates and therapies;

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●

our plans relating to the further development and manufacturing of denifanstat and any other drug candidates we may develop, including additional indications that we may pursue for denifanstat or other drug candidates;

●

our ability to obtain sufficient funding or enter into a strategic collaboration to initiate Phase 3 clinical trials for denifanstat in metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH);

●

existing regulations and regulatory developments in the United States and other jurisdictions;

●

our potential and ability to successfully manufacture and supply denifanstat and any other drug candidates we may develop for clinical trials and for commercial use, if approved;

●

the rate and degree of market acceptance of denifanstat and any other drug candidates we may develop, as well as the pricing and reimbursement of denifanstat and any other drug candidates we may develop, if approved;

●

our expectations regarding our ability to obtain, maintain, protect and enforce intellectual property protection for denifanstat and for any other future drug candidate;

●

our ability to realize the anticipated benefits of any strategic transactions;

●

our ability to attract and retain the continued service of our key personnel and to identify, hire, and then retain additional qualified personnel and our ability to attract additional collaborators with development, regulatory and commercialization expertise;

●

the impact of macroeconomic conditions and geopolitical turmoil on our business and operations;

●

our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; and

●

our anticipated use of our existing cash, cash equivalents and marketable securities.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” set forth in Part II, Item 1A “Risk Factors” in this Quarterly Report, the section titled “Risk Factors” set forth in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 and the section titled “Risk Factors” set forth in Part II, Item 1A of our subsequent Quarterly Reports on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein until after we distribute this Quarterly Report, whether as a result of any new information, future events or otherwise.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.

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PART I. FINANCIAL INFORMATION

Item 1. Condensed Financial Statements

SAGIMET BIOSCIENCES INC.

CONDENSED BALANCE SHEETS

(unaudited)

(in thousands, except for share and per share amounts)


	As of
	March 31,		December 31,
	2025		2024
Assets
Current assets:
Cash and cash equivalents	$	64,717	$	75,840
Short-term marketable securities		79,852		75,410
Prepaid expenses and other current assets		1,503		1,524
Total current assets		146,072		152,774
Long-term marketable securities		—		7,408
Operating lease right-of-use assets		38		77
Other long-term assets		62		—
Total assets	$	146,172	$	160,259
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	3,223	$	1,425
Accrued expenses and other current liabilities		3,918		2,951
Operating lease liabilities		39		78
Total current liabilities		7,180		4,454
Commitments and contingencies (Note 6)
Stockholders’ equity:
Undesignated preferred stock, $0.0001 per share: 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2025 and December 31, 2024		—		—
Series A common stock, $0.0001 per share: 500,000,000 shares authorized; 30,674,855 shares issued and outstanding at March 31, 2025 and December 31, 2024		3		3
Series B common stock, $0.0001 per share: 15,000,000 shares authorized; 1,520,490 shares issued and outstanding at March 31, 2025 and December 31, 2024		—		—
Additional paid-in capital		452,355		450,883
Accumulated deficit		(313,487)		(295,311)
Accumulated other comprehensive income		121		230
Total stockholders’ equity		138,992		155,805
Total liabilities and stockholders’ equity	$	146,172	$	160,259

The accompanying notes are an integral part of these unaudited condensed financial statements.

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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,
	2025		2024
Operating expenses:
Research and development	$	15,342	$	5,262
General and administrative		4,523		3,506
Total operating expenses		19,865		8,768
Loss from operations		(19,865)		(8,768)
Other income:
Interest income and other, net		1,689		2,139
Total other income		1,689		2,139
Net loss	$	(18,176)	$	(6,629)

Net loss per share of Series A and Series B common stock outstanding, basic and diluted	$	(0.56)	$	(0.23)
Weighted-average shares of Series A and Series B common stock outstanding, basic and diluted		32,195,345		29,039,427

Net loss	$	(18,176)	$	(6,629)
Other comprehensive loss:
Net unrealized loss on marketable securities		(109)		(23)
Total comprehensive loss	$	(18,285)	$	(6,652)

The accompanying notes are an integral part of these unaudited condensed financial statements.

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SAGIMET BIOSCIENCES INC.

CONDENSED STATEMENTS OF

STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands, except share amounts)


													Accumulated
	Series A				Series B				Additional				Other		Total
	Common Stock				Common Stock				Paid-in		Accumulated		Comprehensive		Stockholders’
	Shares		Amount		Shares		Amount		Capital		Deficit		Income (Loss)		Equity
Balance at January 1, 2025		30,674,855	$	3		1,520,490	$	—	$	450,883	$	(295,311)	$	230	$	155,805
Stock-based compensation expense		—		—		—		—		1,472		—		—		1,472
Unrealized loss on marketable securities		—		—		—		—		—		—		(109)		(109)
Net loss		—		—		—		—		—		(18,176)		—		(18,176)
Balance at March 31, 2025		30,674,855	$	3		1,520,490	$	—	$	452,355	$	(313,487)	$	121	$	138,992


													Accumulated
	Series A				Series B				Additional				Other		Total
	Common Stock				Common Stock				Paid-in		Accumulated		Comprehensive		Stockholders’
	Shares		Amount		Shares		Amount		Capital		Deficit		Income (Loss)		Equity
Balance at January 1, 2024		21,375,402	$	2		1,520,490	$	—	$	340,777	$	(249,744)	$	30	$	91,065
Sale of Series A common stock, net of issuance costs of $7,796		9,000,000		1		—		—		104,731		—		—		104,732
Issuance of Series A common stock upon exercise of stock options		17,995		—		—		—		114		—		—		114
Stock-based compensation expense		—		—		—		—		759		—		—		759
Unrealized loss on marketable securities		—		—		—		—		—		—		(23)		(23)
Net loss		—		—		—		—		—		(6,629)		—		(6,629)
Balance at March 31, 2024		30,393,397	$	3		1,520,490	$	—	$	446,381	$	(256,373)	$	7	$	190,018

The accompanying notes are an integral part of these unaudited condensed financial statements

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SAGIMET BIOSCIENCES INC.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)


	Three Months Ended March 31,
	2025		2024
Cash flows from operating activities
Net loss	$	(18,176)	$	(6,629)
Adjustments to reconcile net loss to net cash used in operating activities:
Accretion of discount on marketable securities		(535)		(193)
Non-cash operating lease expense		39		36
Stock-based compensation expense		1,472		759
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(687)		640
Accounts payable, accrued expenses and other current liabilities		3,390		(782)
Operating lease liabilities		(39)		(39)
Net cash used in operating activities		(14,536)		(6,208)
Cash flows from investing activities
Purchases of marketable securities		(15,575)		—
Sales and maturities of marketable securities		18,988		3,000
Net cash provided by investing activities		3,413		3,000
Cash flows from financing activities
Proceeds from sale of Series A common stock, net of issuance costs		—		105,750
Payment of financing costs		—		(1,018)
Proceeds from exercise of stock options		—		114
Net cash provided by financing activities		—		104,846
Net (decrease) increase in cash and cash equivalents		(11,123)		101,638
Cash and cash equivalents at beginning of period		75,840		75,139
Cash and cash equivalents at end of period	$	64,717	$	176,777

Supplemental non-cash investing and financing activities:
Deferred financing costs within accounts payable and accrued expenses	$	245	$	—

The accompanying notes are an integral part of these unaudited condensed financial statements.

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SAGIMET BIOSCIENCES INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS (unaudited)

1.	Description of Business and Basis of Presentation

Description of business

Sagimet Biosciences Inc. (the Company), a Delaware corporation headquartered in San Mateo, California, is a clinical-stage biopharmaceutical company developing novel therapeutics called fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. The Company’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for metabolic dysfunction-associated steatohepatitis (MASH), acne, and select forms of cancer. FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet’s second FASN inhibitor, TVB-3567, a potent and selective small molecule FASN inhibitor, received IND clearance in March 2025, allowing initiation of a first-in-human Phase 1 clinical trial in acne. The Company’s license partner, Ascletis BioScience Co. Ltd. (Ascletis), is currently testing denifanstat in a Phase 3 trial in moderate to severe acne vulgaris and in a Phase 3 trial in recurrent glioblastoma multiforme (GBM) in combination with bevacizumab, both in China.

Basis of presentation

The accompanying financial statements have been prepared in accordance with accounting principles generally accepted (GAAP) in the United States. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB).

These unaudited interim financial statements and accompanying notes should be read in conjunction with the Company’s annual financial statements and the notes thereto included in the Company’s Form 10-K, as filed with the Securities and Exchange Commission (SEC) on March 12, 2025. The accompanying interim financial statements as of March 31, 2025 and for the three months ended March 31, 2025 and 2024 are unaudited but include all adjustments that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2024 have been derived from the audited financial statements as of that date.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Such estimates include accruals of research and development expenses, accrued costs for services rendered under agreements with third-party contract research organizations (CROs) and stock option valuations and stock-based compensation. On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates.

Emerging growth company status

The Company is an emerging growth company (EGC) as defined in the Jumpstart Our Business Startups Acts of 2012, as amended (the JOBS Act), and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. The Company may take advantage of these exemptions until it is no longer an EGC under Section 107 of the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting standards. As a result of this election, the Company’s financial statements may not be comparable to those issued by companies that comply with the effective dates pursuant to public company FASB standards.

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Liquidity

The accompanying unaudited financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. As of March 31, 2025, the Company has relied on public and private equity and debt financings and proceeds from licensing arrangements to fund its operations. The Company has incurred recurring losses and negative cash flows from operations since inception, and, as of March 31, 2025, had an accumulated deficit of $313.5 million and cash, cash equivalents and marketable securities of $144.6 million. The Company expects to incur additional losses and negative cash flows from operations for the foreseeable future.

In July and August 2023, the Company completed its initial public offering (IPO) and, inclusive of the partial exercise of the underwriters’ overallotment option, the Company sold an aggregate of 6,026,772 shares of Series A common stock at a public offering price of $16.00 per share and received $86.2 million in net proceeds. In January 2024, the Company completed a follow-on offering whereby it sold 9,000,000 shares of its Series A common stock at a price of $12.50 per share and received $104.7 million in proceeds, net of issuance costs of $7.8 million.

In August 2024, the Company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. to establish an at-the-market offering (ATM Offering) through which the Company may sell, from time to time at its sole discretion, up to $75.0 million shares of its Series A common stock. There were no sales under the ATM Offering during the three months ended March 31, 2025.

The Company expects that its cash, cash equivalents and marketable securities as of March 31, 2025 will be sufficient to fund the Company’s operating expenses for at least the next 12 months from the issuance of these financial statements. In the future, the Company will need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or issue debt financing, may provide additional liquidity in the future, however these actions are not solely within the control of the Company and the Company is unable to predict the outcome of these actions to generate the liquidity ultimately required.

2.	Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited financial statements and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 12, 2025. Since the date of those audited financial statements, there have been no material changes to the Company’s significant accounting policies.

Net loss per share attributable to common stockholders

Basic and diluted net loss per share is computed using the two-class method required for multiple classes of common stock and participating securities. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders for all periods presented. Basic net loss per common share attributable to common stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share attributable to common stockholders’ calculation, common stock options, restricted stock units and common stock warrants are considered to be potentially dilutive securities. As the Company has reported a net loss for the periods presented, basic and diluted net loss per share attributable to common stockholders is the same as all potentially dilutive securities would have an anti-dilutive impact.

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The following table presents the calculation of basic and diluted net loss per share for the three months ended March 31, 2025 and 2024 (in thousands, except share and per share data):


	Three Months Ended March 31,
	2025		2024
Numerator:
Net loss	$	(18,176)	$	(6,629)
Denominator:
Weighted-average shares of Series A and Series B common stock outstanding, basic and diluted		32,195,345		29,039,427
Net loss per share of Series A and Series B common stock outstanding, basic and diluted	$	(0.56)	$	(0.23)

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of Series A and Series B common stock outstanding, as their effect would have been anti-dilutive:


	Three Months Ended March 31,
	2025	2024
Options to purchase Series A common stock	5,494,659	3,518,803
Warrants to purchase Series A common stock	1,000	1,000
Unvested restricted stock units	1,098,399	1,125,840
Total	6,594,058	4,645,643

New accounting pronouncements not yet adopted

The Company considers the applicability and impact of all ASUs. ASUs not discussed below were assessed and either determined to be not applicable or expected to have minimal impact on the Company’s financial statements.

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires public business entities to disclose, for interim and annual reporting periods, additional information about certain income statement expense categories. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently evaluating the impact of the adoption of this standard on its financial statements and related disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures, a final standard on improvements to income tax disclosures. The standard requires disaggregated information about a reporting entity's effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions and applies to all entities subject to income taxes. The new standard is effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of the adoption of this standard on its disclosures and will adopt the ASU for its Annual Report on Form 10-K for the year ended December 31, 2025.

3.	Fair Value Measurements and Fair Value of Financial Instruments

The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:

Level 1 - Quoted prices in active markets for identical assets or liabilities.

Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

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Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

As of March 31, 2025 and December 31, 2024, financial assets measured at fair value on a recurring basis consisted of cash equivalents and marketable securities. Cash equivalents consist primarily of money market funds and other investments that are readily convertible into cash and have maturities of three months or less at the time of acquisition. The fair value of cash equivalents was $64.2 million and $75.3 million as of March 31, 2025 and December 31, 2024, respectively. The Company considers marketable securities with maturities greater than three months at the time of acquisition to be available-for-sale securities. The fair value of available-for-sale securities was $79.9 million and $82.8 million as of March 31, 2025 and December 31, 2024, respectively. These available-for-sale securities have expected maturities ranging from 0.03 to 10.7 months. The fair value of marketable securities, which are Level 2 financial instruments, is based upon market prices quoted on the last day of the fiscal period or other observable market inputs. The Company obtains pricing information from its investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker-dealer quotes, bids and/or offers.

The Company evaluates securities with unrealized losses, if any, to determine whether the decline in fair value has resulted from credit loss or other factors, including various qualitative factors. As of March 31, 2025, the Company has not recognized any impairment or credit losses on the Company’s available-for-sale securities. While the Company classifies these securities as available-for-sale, the Company does not intend to sell its investments and based on its current plans, the Company currently believes it has the ability to hold these investments until maturity.

The carrying values of the Company’s accounts payable and accrued expenses and other current liabilities approximate their fair values due to the short-term nature of these liabilities.

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.

The Company’s Level 3 liabilities that are measured at fair value on a recurring basis consist of the Series A common stock warrant liability related to the warrant to purchase 1,000 shares of Series A common stock with an exercise price of $69.94 per share and an expiration date of July 18, 2026, the third anniversary date of the closing of the Company’s IPO. The fair value of Series A common stock warrant liability was immaterial as of March 31, 2025 and December 31, 2024, as well as the change in fair value during the three months ended March 31, 2025 and 2024. There were no transfers within the hierarchy during the periods presented.

The following tables set forth the Company’s financial assets that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):


		March 31, 2025
	Valuation	Amortized		Unrealized		Unrealized
	Hierarchy	cost		Gains		Losses		Fair Value
Assets
Cash equivalents:
Money market funds	Level 1	$	64,201	$	—	$	—	$	64,201
Total cash equivalents			64,201		—		—		64,201
Short-term marketable securities:
Commercial paper	Level 2		20,988		4		(2)		20,990
Corporate debt securities	Level 2		4,465		2		—		4,467
U.S. Treasury securities	Level 2		39,924		109		—		40,033
Agency securities	Level 2		11,868		—		(2)		11,866
Asset-backed securities	Level 2		2,486		10		—		2,496
Total short-term marketable securities			79,731		125		(4)		79,852
Total cash equivalents and marketable securities		$	143,932	$	125	$	(4)	$	144,053

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		December 31, 2024
	Valuation	Amortized		Unrealized		Unrealized
	Hierarchy	cost		Gains		Losses		Fair Value
Assets
Cash equivalents:
Money market funds	Level 1	$	72,800	$	—	$	—	$	72,800
U.S. Treasury securities	Level 2		2,477		—		—		2,477
Total cash equivalents			75,277		—		—		75,277
Short-term marketable securities:
Commercial paper	Level 2		14,447		25		(1)		14,471
Corporate debt securities	Level 2		6,909		7		—		6,916
U.S. Treasury securities	Level 2		27,493		123		—		27,616
Agency securities	Level 2		21,345		12		(2)		21,355
Asset-backed securities	Level 2		5,030		22		—		5,052
Total short-term marketable securities			75,224		189		(3)		75,410
Long-term marketable securities:
U.S. Treasury securities	Level 2		4,884		36		—		4,920
Asset-backed securities	Level 2		2,480		8		—		2,488
Total long-term marketable securities			7,364		44		—		7,408
Total cash equivalents and marketable securities		$	157,865	$	233	$	(3)	$	158,095

4.	Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):


	As of
	March 31,		December 31,
	2025		2024
Prepaid clinical costs	$	226	$	436
Prepaid research and development costs		112		48
Prepaid insurance		277		577
Deferred financing costs		625		306
Other		263		157
Total prepaid expenses and other current assets	$	1,503	$	1,524

5.	Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	As of
	March 31,		December 31,
	2025		2024
Accrued payroll-related costs	$	423	$	1,358
Accrued clinical costs		665		528
Accrued research and development costs		1,829		516
Accrued general and administrative costs		938		544
Accrued offering costs		47		—
Other		16		5
Total accrued expenses and other current liabilities	$	3,918	$	2,951

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6.	Commitments and Contingencies

License and other agreements

Ascletis BioScience Co. Ltd

In January 2019, the Company entered into a license agreement that became effective in February 2019 with Ascletis BioScience Co. Ltd. (Ascletis), a subsidiary of Ascletis Pharma Inc. (Ascletis Pharma), a biotechnology company incorporated in the Cayman Islands and headquartered in Hangzhou, China. Ascletis Pharma, through a subsidiary, was the lead investor in the Company’s Series E redeemable convertible preferred stock financing in February 2019. The parties entered into this agreement with the intention to develop, manufacture, and commercialize the Company’s proprietary FASN inhibitor, denifanstat, which Ascletis refers to as ASC40. Under the terms of the license agreement, the Company granted Ascletis and its affiliates an exclusive, royalty-bearing sublicensable right and license under the Company’s intellectual property to develop, manufacture, commercialize and otherwise exploit denifanstat and other products containing denifanstat-related compounds in Greater China, consisting of the People’s Republic of China, Hong Kong, Macau and Taiwan.

The Company is eligible to receive development and commercial milestone payments from Ascletis in aggregate of up to $122.0 million as well as tiered royalties ranging from percentages in the high single digits to mid-teens on future net sales of denifanstat in Greater China. The license and the research and development services components of this license agreement are representative of a relationship with a customer, and therefore, the Company evaluated the license agreement under the provisions of ASC 606, Revenue from Contracts with Customers. The developmental and commercial event-based milestone payments represent variable consideration, and the Company used the most likely amount method to estimate this variable consideration because the potential milestone payment is a binary event, as the Company will either receive the milestone payment or it will not. Given the high degree of uncertainty around achievement of these milestones, the Company determined the milestone amounts to be fully constrained and will not recognize revenue until the uncertainty associated with these payments is resolved. Any consideration related to royalties will be recognized if and when the related sales occur. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur.

In July 2023, the Company entered into an Assignment and Assumption Agreement with Ascletis and Ascletis’ affiliate Gannex Pharma Co., Ltd. (Gannex) under which Ascletis, while remaining responsible for performance under the license agreement, assigned all of its rights and obligations under the license agreement to Gannex and Gannex assumed such rights and obligations, effective as of October 2019.

Facility Lease Agreement

On March 12, 2019, the Company executed a 38-month non-cancelable operating lease agreement for 3,030 square feet of office space for its headquarters facility in San Mateo, California, which commenced April 1, 2019. The lease provides for monthly lease payments of approximately $12,000 with annual increases. In December, 2021, the lease agreement was amended to extend the term of the lease through June 2024; in April 2024, the Company amended the lease agreement to (i) extend the lease through June 30, 2025 and (ii) increase the monthly lease payment to approximately $13,000 beginning on July 1, 2024, which resulted in an increase in the Company’s operating lease right-of-use asset and corresponding operating lease liability of $0.1 million on the amendment date.

Operating lease costs were $39,000 and $37,000 for the three months ended March 31, 2025, and 2024, respectively.

Guarantees and indemnifications

In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. As of March 31, 2025, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.

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Legal Proceedings

From time to time, the Company may become involved in various legal proceedings that arise in the ordinary course of its business. The Company records a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Significant judgment by the Company is required to determine both probability and the estimated amount. The Company is not party to any material legal proceedings as of March 31, 2025.

7.	Stock-Based Compensation

The 2023 Stock Option and Incentive Plan (2023 Plan) was adopted by the board of directors, approved by the Company’s stockholders on July 4, 2023, and became effective on July 13, 2023, replacing the 2017 Equity Incentive Plan. The number of shares initially reserved for issuance under the 2023 Plan was 2,585,968. The number of shares will automatically increase each January 1, by (i) 4% of the outstanding number of shares of the Company’s Series A common stock on the immediately preceding December 31 or (ii) a lesser number of shares as determined by the compensation committee of the board of directors. In accordance with the 2023 Plan, the shares reserved for issuance automatically increased by 855,016 shares on January 1, 2024, and by 1,226,994 shares on January 1, 2025. As of March 31, 2025, the aggregate maximum number of shares reserved for issuance under the 2023 Plan was 4,667,978, of which 1,670,598 shares were available for future grant. Option grants issued under the 2023 Plan are exercisable for up to 10 years from the date of issuance.

In March 2024, the Company established a pool of 1,000,000 shares of Series A common stock (Inducement Pool) from which equity grants in the form of options and restricted stock units may be issued as inducement for new employees to accept employment offers from the Company or for individuals returning to employment after a bona fide period of non-employment with the Company. Inducement Pool grants are granted outside of the 2023 Plan and do not require approval from the Company’s stockholders pursuant to the Nasdaq inducement grant exception in accordance with Nasdaq Listing Rule 5635(c)(4). In February 2025, the Company increased the number of shares available for issuance by 300,000 shares, increasing the total number of shares available for issuance under the Inducement Pool to 1,300,000 shares. As of March 31, 2025, 404,017 shares were available for future grants from the Inducement Pool.

Total stock-based compensation recorded in the condensed statements of operations and comprehensive loss related to stock options and restricted stock units for employees and non-employees was as follows (in thousands):


	Three Months Ended March 31,
	2025		2024
Stock options	$	1,223	$	449
Restricted stock units		249		310
Total stock-based compensation expense	$	1,472	$	759
Included in:
General and administrative expense	$	1,248	$	513
Research and development expense		224		246
Total stock-based compensation expense	$	1,472	$	759

Stock options

The Company grants stock options which consist of (i) time-based options, which vest and become exercisable, subject to the participant’s continued employment or service through the applicable vesting date and (ii) performance-based options, which vest based on performance measures against predetermined objectives that include successful completion of qualified equity offerings or announced

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topline results for clinical trials and positive clinical results over a specified performance period. The Company’s time-based options have various vesting schedules that range from vesting immediately to vesting over a four-year period.

The following table summarizes stock option activity for the three months ended March 31, 2025 (in thousands, except share and per share data):


				Weighted-
	Number of			Average
	Shares	Weighted-		Remaining
	Underlying	Average		Contractual	Aggregate
	Outstanding	Exercise		Term	Intrinsic
	Options	Price		(in Years)	Value (1)
Outstanding, January 1, 2025	4,462,517	$	6.58	7.4	$	619
Granted	1,032,289		4.71
Forfeited/expired	(147)		23.05
Outstanding, March 31, 2025 ⁽²⁾	5,494,659	$	6.23	7.7	$	26
Vested and expected to vest, March 31, 2025	5,494,659	$	6.23	7.7	$	26
Exercisable at March 31, 2025	2,741,368	$	7.06	6.2	$	—

____________

(1)

Aggregate intrinsic value represents the difference between the fair value of the Company’s Series A common stock on the last day of the fiscal period and the exercise price, multiplied by the number of options outstanding.

(2)

Includes 492,729 performance-based options with a weighted-average exercise price of $6.42, all of which were fully vested and exercisable.

During the three months ended March 31, 2025 and 2024, the weighted average grant-date fair value per share of stock options granted was $3.71 and $4.34, respectively. The total intrinsic value of stock options exercised during the three months ended March 31, 2024, was $0.1 million. Additionally, during the three months ended March 31, 2024, cash received from the exercise of stock options was approximately $0.1 million.

As of March 31, 2025, there was $11.1 million of unrecognized compensation expense, which is expected to be recognized over a remaining weighted-average period of 2.7 years.

Restricted stock units

The Company’s restricted stock units generally vest over a four-year period in equal amounts on an annual basis, provided the employee remains continuously employed with the Company. The fair value of the restricted stock units is equal to the closing price of the Company’s Series A common stock on the grant date.

The following table summarizes restricted stock unit activity:


		Weighted-Average
	Restricted	Grant Date
	Stock Units	Fair Value
Outstanding, January 1, 2025	844,382	$	2.96
Granted	254,017		4.71
Outstanding, March 31, 2025	1,098,399	$	3.36

As of March 31, 2025, the total unrecognized compensation expense related to unvested restricted stock units was $3.1 million, which is expected to be recognized over a remaining weighted-average period of 2.9 years.

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Valuation assumptions

The fair value of each stock option granted was estimated on the date of grant using the Black-Scholes option pricing model using the following assumptions:


	Three Months Ended March 31,
	2025		2024
Expected volatility	95.0	%	96.0	%
Risk-free interest rate	4.3	%	4.1	%
Dividend yield	—		—
Expected term (in years)	6.0		6.1

The expected term is determined using the simplified method, which represents the average of the contractual term of the options and the weighted-average expected vesting period. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the option. The expected stock volatility rate is based on the volatility rates of comparable publicly held companies over a period equal to the expected term of the option. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends to stockholders and has no current intentions to pay cash dividends.

Employee stock purchase plan

The 2023 Employee Stock Purchase Plan (the ESPP) was adopted by the board of directors in July 2023 with an initial total of 215,497 shares of Series A common stock reserved for issuance. Under the ESPP plan, the amount of shares reserved automatically increases each January 1 through January 1, 2033, by the least of (i) 215,497 shares of Series A common stock, (ii) 1% of the outstanding number of shares of the Company’s Series A common stock on the immediately preceding December 31 or (iii) such lesser number of shares of Series A common stock as determined by the administrator of the ESPP. In accordance with the ESPP, the shares reserved for issuance automatically increased by 213,754 shares on January 1, 2024, and by 215,497 shares on January 1, 2025. As of March 31, 2025, the aggregate maximum number of shares reserved for issuance under the ESPP was 644,748. No shares of Series A common stock have been issued under the ESPP to date.

8.	Related Party Transactions

Jinzi J. Wu, Ph.D., a member of the Company’s board of directors until June 2024, founded and serves as the chief executive officer of Ascletis, Gannex, and Ascletis Pharma.

During the three months ended March 31, 2024, the Company recognized $96,000 of expenses under the Ascletis license agreement, inclusive of manufacturing services fees charged by Ascletis pursuant to the manufacturing agreement with Ascletis which falls under the license agreement. These expenses are recorded in research and development expense in the statements of operations and comprehensive loss.

9.	Segment Reporting

Operating segments are defined as components of an entity about which discrete financial information is evaluated regularly by the chief operating decision maker (CODM) in deciding how to allocate resources and assess performance. The Company operates and manages its business as one business segment, which is development and commercialization of therapeutics for the treatment of MASH and other diseases where FASN plays a pathogenic role. Accordingly, the Company has one reportable segment. The Company has a single management team that reports to the Chief Executive Officer, the Company's CODM, who comprehensively manages the entire Company. The accounting policies of the segment are the same as those described in the summary of significant accounting policies.

When evaluating the Company’s financial performance, the CODM is regularly provided with more detailed expense information than what is included in the Company’s statements of operations and comprehensive loss. The CODM uses net loss, as reported in the statements of operations and comprehensive loss, in evaluating the performance of the segment. Decisions regarding resource allocation are made primarily during the annual budget planning process and reallocated as needed throughout the year. The measure of segment assets is reported on the balance sheets as total assets.

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The following table shows a reconciliation of the Company’s net loss, including the significant expense categories regularly provided to and reviewed by the CODM, as computed under U.S. GAAP, to the Company’s total net loss in the statements of operations and comprehensive loss, for the three months ended March 31, 2025, and 2024 (in thousands):



	Three Months Ended March 31,
	2025		2024
External research and development expenses		14,170		4,191
External general and administrative expenses		2,252		2,097
Personnel costs		1,951		1,478
Stock-based compensation		1,472		759
Other segment items ⁽¹⁾		(1,669)		(1,896)
Segment net loss	$	18,176	$	6,629

(1)

Other segment items consist of (i) interest and other income, net and (ii) other internal operating research and development expenses.

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ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed financial statements and related notes included elsewhere in this report on Form 10-Q for the quarter ended March 31, 2025 (Quarterly Report). This discussion and analysis and other parts of this Quarterly Report contain forward-looking statements based upon our current plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and beliefs. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and elsewhere in this Quarterly Report. You should carefully read the “Risk Factors” section of this Quarterly Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements.

Overview

We are a clinical-stage biopharmaceutical company developing novel therapeutics called fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Our lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), acne, and select forms of cancer.

Denifanstat has been studied in over 740 people to date in our clinical trials, including our Phase 2 FASCINATE-1 and Phase 2b FASCINATE-2 clinical trials. In January 2024, we announced positive topline results from the Phase 2b FASCINATE-2 clinical trial evaluating denifanstat in 168 biopsy-confirmed MASH patients with stage F2 or F3 fibrosis compared to placebo at week 52. The Phase 2b FASCINATE-2 clinical trial achieved statistically significant results on primary and multiple secondary endpoints at week 52 in MASH patients in the modified intention to treat (mITT) population, including:

•

The primary endpoints of ≥2-point reduction in NAS (NAFLD Activity Score) without worsening of fibrosis (denifanstat 52% vs. placebo 20%, p=0.0003), and MASH resolution without worsening of fibrosis with ≥2-point reduction in NAS (denifanstat 36% vs. placebo 13%, p=0.0044).

•

Multiple secondary endpoints of fibrosis improvement by ≥ 1 stage with no worsening of MASH (denifanstat 41% vs. placebo 18%, p=0.0102), MASH resolution with no worsening of fibrosis (denifanstat 38% vs. placebo 16%, p=0.0043), and a greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) ≥30% responders relative to placebo (denifanstat 65% vs. placebo 21%, p<0.0001). MRI-PDFF responders are patients with ≥8% liver fat content at baseline who achieve a ≥30% relative reduction of liver fat at the end of treatment.

Denifanstat showed also statistical significance in fibrosis improvement as measured by an artificial intelligence (AI) digital pathology-based qFibrosis assessment. Additionally, our precision medicine approach is core to our development strategy in MASH and includes the identification of pharmacodynamic and predictive biomarkers to confirm target engagement and clinical response in patients treated with denifanstat.

In June 2024, we presented positive data from the Phase 2b FASCINATE-2 clinical trial of denifanstat versus placebo in biopsy-confirmed MASH patients at the European Association for the Study of the Liver (EASL) Congress. Our EASL presentation included the following 52-week data from the ITT, mITT, and F3 mITT patient populations:

•

The primary endpoint of ≥2-point reduction in NAS without worsening of fibrosis (denifanstat 38% vs. placebo 16%, p=0.0035) or MASH resolution with ≥2-point reduction in NAS without worsening of fibrosis (denifanstat 26% vs. placebo 11%, p=0.0173) in the ITT population.

•

Secondary endpoints of fibrosis improvement by ≥ 1 stage with no worsening of MASH in the ITT (denifanstat 30% vs. placebo 14%, p=0.040) and F3 mITT (denifanstat 49% vs. placebo 13%, p=0.0032) populations.

•

Fibrosis improvement by ≥ 2 stages with no worsening of MASH in the mITT (denifanstat 20% vs. placebo 2%, p=0.0065) and F3 mITT (denifanstat 34% vs. placebo 4%, p=0.0065) populations.

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•

A statistically significant difference in progression to cirrhosis (F4) in mITT population (denifanstat 5% vs. placebo 11%, p=0.0386).

•

A statistically significant difference in fibrosis improvement by ≥ 1 stage with no worsening of MASH for patients on a stable background dose of a GLP-1Receptor Agonist (denifanstat 42% vs. placebo 0%, p=0.034) in the mITT population.

•

A statistically significant increase in beneficial polyunsaturated triglycerides at the end of 52 weeks of treatment (+42% denifanstat vs. -4% placebo, 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 (-2.4ug/ml with denifanstat vs. -0.4ug/mL placebo, p=0.001) and 13-weeks (-2.2ug/mL with denifanstat vs. -0.1ug/mL placebo, p=0.005) in the ITT population.

In October 2024, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to denifanstat for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Treatments that receive Breakthrough Therapy designation must target a serious or life-threatening disease and preliminary clinical evidence must indicate that the drug may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints. Breakthrough Therapy designation of denifanstat was supported by positive data from the Phase 2b FASCINATE-2 clinical trial in biopsy-confirmed MASH patients with stage 2 or stage 3 fibrosis.

In October 2024, we announced the publication of results from the Phase 2b FASCINATE-2 clinical trial of denifanstat in The Lancet Gastroenterology & Hepatology. The publication, titled “Denifanstat for the treatment of metabolic-dysfunction associated steatohepatitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2b trial,” reported that denifanstat treatment achieved statistically significant and clinically meaningful improvements in disease activity, MASH resolution and fibrosis.

In October 2024, we completed successful end-of-Phase 2 interactions with the FDA, supporting the advancement of denifanstat into Phase 3 clinical trials in MASH. The Phase 3 program design includes two double-blind, placebo-controlled multicenter registrational trials: FASCINATE-3, evaluating patients with F2/F3 (non-cirrhotic) MASH, and FASCINIT, evaluating patients with suspected or confirmed diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH. While we are operationally ready to dose patients in the Phase 3 trials, we do not intend to initiate these trials until such time as we have sufficient funding to do so. We are currently exploring various alternatives to fund the ongoing development of denifanstat as a monotherapy.

In the second half of 2025, subject to consultation with regulatory authorities, we plan to initiate a Phase 1 clinical trial to evaluate the pharmacokinetics (PK) and tolerability of a combination of denifanstat and resmetirom with an anticipated data readout in the first half of 2026. We presented pre-clinical data at EASL in 2024 for two mouse models of MASH, showing that the combination of a FASN inhibitor (TVB-3664, a surrogate for denifanstat) and the thyroid hormone receptor beta (THRb) agonist, resmetirom, had a synergistic effect on important liver disease markers, including improvement of NAS by histologic analysis and more robust improvement in hepatic collagen content compared to the single agents. Synergistic activity of the combination was demonstrated in the rate of histological improvement (NAS ≥2 points). The FASN inhibitor monotherapy showed 33% improvement, resmetirom monotherapy showed 25% improvement, and the combination of the two showed an 80% improvement, a level of improvement that greatly exceeds a simple addition of the activity of the two drugs. Given that resmetirom (Rezdiffra™) is currently the only product approved for treatment of MASH, the planned Phase 1 clinical PK trial would allow us to explore the compatibility of resmetirom and denifanstat in humans. We anticipate building on the outcome of this Phase 1 clinical PK trial, if positive, to develop a combination product for MASH patients.

In addition to MASH, we are exploring our FASN inhibitors in acne, in which dysregulation of fatty acid metabolism also plays a key role. Denifanstat is currently being tested in China in moderate to severe acne vulgaris by our license partner, Ascletis BioScience Co. Ltd. (Ascletis), a subsidiary of Ascletis Pharma Inc. (Ascletis Pharma), in a Phase 3 clinical trial. In November 2024, Ascletis announced completion of enrollment of 480 patients in the acne Phase 3 clinical trial and that it expects to announce topline results in the second quarter of 2025.

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In March 2025, we announced the clearance of our Investigational New Drug (IND) application for a first-in-human Phase 1 clinical trial of our second FASN inhibitor, TVB-3567. TVB-3567 is a potent and selective small molecule FASN inhibitor, planned to enter clinical development for the treatment of acne. The IND clearance allows us to initiate a first-in-human Phase 1 clinical trial of TVB-3567 for development of an acne indication, which we expect to initiate in the second half of 2025. The planned Phase 1 clinical trial will be a randomized double-blind placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TVB-3567 in healthy participants with or without acne. The trial is expected to be comprised of several parts, including single ascending dose cohorts and multiple ascending dose cohorts in participants without acne, followed by testing in participants with acne including evaluation of pharmacodynamic biomarkers.

We are also exploring the use of our FASN inhibitors in select forms of cancer. Denifanstat is currently being tested in China by Ascletis in a Phase 3 clinical trial in recurrent glioblastoma multiforme (GBM) in combination with bevacizumab.

Components of results of operations

Research and development expenses

Research and development expenses represent costs incurred in performing research, development and manufacturing activities in support of our own product development efforts and include internal personnel-related costs (such as salaries, employee benefits and stock-based compensation) for our personnel in research and development functions; as well as external costs, including costs related to acquiring, developing and manufacturing supplies for preclinical studies, clinical trials and other studies, including fees paid to contract manufacturing organizations (CMOs); costs and expenses related to agreements with contract research organizations (CROs), investigative sites and consultants to conduct non-clinical and preclinical studies and clinical trials; professional and consulting services costs; and facility and other allocated costs.

All research and development expenses are charged to operations as incurred in accordance with Accounting Standards Codification 730, Research and Development. We account for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made.

We expect our research and development expenses to increase substantially for the foreseeable future as we advance our drug candidates into and through preclinical studies and clinical trials, pursue regulatory approval and expand our pipeline.

General and administrative expenses

Our general and administrative expenses consist primarily of costs and expenses related to: personnel (including salaries, employee benefits and stock-based compensation) in our executive, finance and accounting and other administrative functions; legal services, including relating to intellectual property and corporate matters; accounting, auditing, consulting and tax services; insurance; information technology; and facility and other allocated costs not otherwise included in research and development expenses.

We expect our general and administrative expenses to increase substantially for the foreseeable future as we increase our headcount and continue to grow our corporate infrastructure. We also anticipate that we will incur increased expenses as a result of operating as a public company, including expenses related to audit, legal and tax-related services associated with maintaining compliance with Securities and Exchange Commission (SEC) rules and regulations and those of any national securities exchange on which our securities are traded, additional insurance expenses, investor relations activities and other administrative and professional services.

Other income

Other income consists primarily of interest income earned on our cash, cash equivalents and marketable securities offset by accretion of discounts to maturity on our marketable securities.

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Results of operations

Comparison of the three months ended March 31, 2025 and 2024

The following table summarizes our results of operations for the periods indicated (in thousands):



	Three Months Ended March 31,
	2025		2024		$ Change		% Change
Operating expenses:
Research and development	$	15,342	$	5,262	$	10,080	192	%
General and administrative		4,523		3,506		1,017	29	%
Total operating expenses		19,865		8,768		11,097	127	%
Loss from operations		(19,865)		(8,768)		(11,097)	127	%
Total other income		1,689		2,139		(450)	(21)
Net loss	$	(18,176)	$	(6,629)	$	(11,547)	174	%

Research and development – Research and development expenses for the three months ended March 31, 2025 and 2024 were comprised of the following (in thousands):



	Three Months Ended March 31,
	2025		2024		$ Change		% Change
External expenses
Clinical development and research	$	11,479	$	1,844	$	9,635	523	%
Manufacturing and non-clinical		2,123		2,001		122	6	%
External consulting and other		568		346		222	64	%
Subtotal - external expenses	$	14,170	$	4,191	$	9,979	238	%
Internal expenses
Personnel costs	$	928	$	582	$	346	59	%
Stock-based compensation		224		246		(22)	(9)	%
Other internal operating expenses		20		243		(223)	(92)	%
Subtotal - internal expenses	$	1,172	$	1,071	$	101	9	%
Total R&D expenses	$	15,342	$	5,262	$	10,080	192	%

Research and development expenses increased by $10.1 million, or 192%, for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This increase was primarily due to (i) a $9.6 million net increase in clinical trial expenses related primarily to start-up costs incurred for our Phase 3 program of denifanstat in MASH, which was partially offset by lower clinical trial expenses for the Phase 2b FASCINATE-2 trial as the trial was substantially complete in the first quarter of 2024 and topline results for the trial were announced in January 2024, and (ii) a $0.3 million increase in personnel costs due to an increase in headcount. External research and development expenses for denifanstat represent substantially all of the external expenses for the three months ended March 31, 2025 and 2024.

General and administrative – General and administrative expenses increased by $1.0 million, or 29%, for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 primarily due to (i) a $0.3 million increase in professional fees, largely due to public company compliance activities, and (ii) a $0.7 million increase in stock-based compensation.

Other income – Other income decreased by $0.5 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, due to a decrease in interest income earned driven by a lower cash, cash equivalents and marketable securities balance during the three months ended March 31, 2025.

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Liquidity and capital resources

Sources and uses of cash

Since our inception, we have devoted substantially all of our resources to researching, discovering and developing our pipeline of proprietary FASN inhibitors and other drug targets, organizing and staffing our company, performing business planning, establishing our intellectual property portfolio, raising capital and general and administration activities to support and expand such activities. We do not have any products approved for sale and have not generated any revenue from product sales. Our revenues to date have been generated solely from the license agreement with Ascletis.

To date, we have financed our operations primarily through public and private equity and debt financings, including our IPO of Series A common stock in July 2023 and our follow-on offering in January 2024, from which we received aggregate net proceeds of $190.9 million. Prior to becoming a public company, we raised $233.3 million in gross proceeds from the sale of our redeemable convertible preferred stock and convertible notes.

In August 2024, we entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. (Cantor) to establish an at-the-market offering (ATM Offering) through which we may offer and sell, from time to time at our sole discretion, up to $75.0 million of shares of our Series A common stock through Cantor acting as our sales agent. There were no sales under the ATM Offering during the three months ended March 31, 2025.

As of March 31, 2025, we had cash, cash equivalents and marketable securities of $144.6 million. We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our drug candidates, which we expect will take a number of years, if ever. We anticipate that we will continue to incur significant expenses for the foreseeable future as we continue to advance our drug candidates through preclinical and clinical trials; manufacture supplies for our preclinical studies and clinical trials; expand our corporate infrastructure, including the costs associated with being a public company; pursue regulatory approval of our drug candidates; hire additional personnel; acquire, discover, validate and develop additional drug candidates; and obtain maintain, expand and protect our intellectual property portfolio.

Until we can generate a sufficient amount of revenue from the commercialization of our drug candidates or additional revenue from collaboration agreements with third parties, if ever, we expect to finance our future cash needs through public or private equity or debt financings, third-party funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. The sale of equity or convertible debt securities may result in dilution to our stockholders and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. Debt financings may subject us to covenant limitations or restrictions on our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Our ability to raise additional funds may be adversely impacted by macroeconomic conditions, disruptions to and volatility in the credit and financial markets and geopolitical turmoil. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable or acceptable to us. If we are unable to obtain adequate financing when needed or on terms favorable or acceptable to us, we may be forced to delay, reduce the scope of or eliminate one or more of our research and development programs.

Our future capital requirements will depend on many factors, including:

●

difficulties obtaining regulatory approval to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial;

●

conditions imposed on us by the FDA or other regulatory authorities regarding the scope or design of our clinical trials;

●

delays in reaching or failing to reach agreement on acceptable terms with prospective CROs, CMOs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly;

●

insufficient supply of our drug candidates or other materials necessary to conduct and complete our clinical trials;

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●

difficulties obtaining institutional review board (IRB) or ethics committee approval to conduct a clinical trial at a prospective site;

●

slow enrollment and retention rate of subjects in our clinical trials;

●

the FDA or other regulatory authority requiring alterations to any of our study designs, our preclinical strategy or our manufacturing plans;

●

governmental or regulatory delays and changes in regulatory requirements, policy and guidelines; serious and unexpected drug-related side effects related to the drug candidate being tested;

●

lack of adequate funding to continue clinical trials;

●

subjects experiencing severe or unexpected drug-related adverse effects;

●

occurrence of severe adverse effects in clinical trials of the same class of agents conducted by other companies;

●

any changes to our manufacturing process, suppliers or formulation that may be necessary or desired;

●

third-party vendors not performing manufacturing and distribution services in a timely manner or to sufficient quality standards;

●

third-party clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, good clinical practice (GCP), or other regulatory requirements;

●

third-party contractors not performing data collection or analysis in a timely or accurate manner;

●

third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications; and

●

failure of our third-party contractors, such as CROs and CMOs, or our investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner.

A change in the outcome of any of these or other variables could significantly change our costs and timing associated with the development of our drug candidates. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such change.

We rely and will continue to rely on third parties in the conduct of our preclinical studies and clinical trials and for manufacturing and supply of our drug candidates. We have no internal manufacturing capabilities, and we will continue to rely on third parties for our preclinical study and clinical trial materials. Given our stage of development, we do not yet have a marketing or sales organization or commercial infrastructure. Accordingly, if we obtain regulatory approval for any of our drug candidates, we also expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.

We enter into contracts in the normal course of business for products and services, including contract research and contract manufacturing services, which include provisions allowing for termination under certain conditions and timelines. These contracts generally do not include payments for early termination and are considered cancellable contracts.

Based on our current business plans, we believe that our existing cash, cash equivalents, and marketable securities as of March 31, 2025, will be sufficient for us to fund our operating expenses for at least the next 12 months from the issuance of this Quarterly Report.

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Cash flows

The following table shows a summary of our cash flows for each of the periods presented below (in thousands):


	Three Months Ended March 31,
	2025		2024
Net cash (used in) provided by:
Operating activities	$	(14,536)	$	(6,208)
Investing activities		3,413		3,000
Financing activities		—		104,846
Net (decrease) increase in cash and cash equivalents	$	(11,123)	$	101,638

Cash flows from operating activities. Net cash used in operating activities was $14.5 million for the three months ended March 31, 2025, and primarily related to cash used to fund clinical development, manufacturing and other non-clinical activities for denifanstat, inclusive of clinical-batch manufacturing and other trial start-up costs for our Phase 3 program of denifanstat in MASH, as well as costs to build out our corporate infrastructure and costs associated with operating as a public company.

Net cash used in operating activities was $6.2 million for the three months ended March 31, 2024, and primarily related to cash used to fund clinical development, manufacturing and other non-clinical activities for denifanstat, inclusive of clinical manufacturing costs related to the conduct of clinical pharmacology trials of denifanstat, as well as costs to build out our corporate infrastructure and costs associated with operating as a public company.

Cash flows from investing activities - Net cash used in investing activities was $3.4 million for the three months ended March 31, 2025 and related to proceeds received from the sale and maturity of marketable securities of $19.0 million, partially offset by purchases of marketable securities of $15.6 million.

Net cash provided by investing activities was $3.0 million for the three months ended March 31, 2024 and related to proceeds received from the sale and maturity of marketable securities.

Cash flows from financing activities - Net cash provided by financing activities was $104.8 million for the three months ended March 31, 2024, which primarily related to the net cash proceeds of $105.7 million received from the sale of our Series A common stock in the January 2024 follow-on offering and $0.1 million in proceeds from stock options exercised during the period, partially offset by the payment of financing costs related to the January 2024 follow-on offering of $1.0 million.

Critical accounting policies and estimates

We prepare our financial statements in accordance with accounting principles generally accepted in the United States of America. The preparation of financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, costs and expenses and related disclosures. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ significantly from the estimates made and changes in estimates may occur.

During the three months ended March 31, 2025, there were no material changes to our critical accounting estimates or in the methodology used for estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024.

Emerging growth company and smaller reporting status

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (the JOBS Act). Under the JOBS Act, emerging growth companies can delay the adoption of new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. Other exemptions and reduced reporting requirements under the JOBS Act for emerging growth companies include an exemption from the requirement to provide an auditor’s report on internal controls over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, as amended, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation and less

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extensive disclosure about our executive compensation arrangements. We have elected to use the extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that (i) we are no longer an emerging growth company or (ii) we affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.

We will remain an emerging growth company until the earliest of (i) the last day of our first fiscal year in which we have total annual gross revenues of $1.235 billion or more, (ii) December 31, 2028, (iii) the date on which we are deemed to be a large accelerated filer, under the rules of the SEC, which means the market value of equity securities that is held by non-affiliates exceeds $700.0 million as of the prior June 30th and (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Recently adopted accounting pronouncements

See “Notes to the Financial Statements—Note 2” included in our unaudited interim financial statements in Item 1 of this Quarterly Report for more information.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.

Item 4. Controls and Procedures

Disclosure controls and procedures

We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, (Exchange Act), that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the end of the period covered by this Quarterly Report. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of March 31, 2025, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed by us in this Quarterly Report was (a) reported within the time periods specified by the SEC rules and regulations, and (b) communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding any required disclosure.

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Changes in internal control over financial reporting

During the quarter ended March 31, 2025, there have been no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which would have a material adverse effect on our results of operations, financial condition or cash flows.

Item 1A. Risk Factors

Our business is subject to substantial risks and uncertainties. You should carefully consider the information contained in this Quarterly Report on Form 10-Q, the risks and uncertainties described below, and the risk factors and other information contained in our other public filings in evaluating our business, including our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 12, 2025.

Our business may be materially adversely affected by the imposition of tariffs and other trade barriers and retaliatory countermeasures implemented by the United States and other governments.

There is currently significant uncertainty about the future relationship between the United States and certain other countries, including China, including potential changes with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations. In April 2025, the United States imposed broad tariffs on imports from virtually all countries, with particularly high tariffs on imports from China. Since this announcement and as of the date of this Quarterly Report, most tariffs for countries other than China have been suspended temporarily. We have previously utilized CMOs outside the United States, including in the UK, EU and China, for the supply of raw materials, API and finished product, and may do so in the future. The recently announced tariffs may lead to higher manufacturing costs, which would have an adverse effect on our business, financial condition and operating results, the extent of which cannot be predicted with certainty at this time.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Recent sales of unregistered equity securities

There were no unregistered sales of equity securities during the period covered by this quarterly report on Form 10-Q.

Use of proceeds from initial public offering of common stock

On July 13, 2023, the registration statement on Form S-1 (File No. 333-256648) relating to our IPO was declared effective by the SEC. There has been no material change in the expected use of the net proceeds from our IPO as described in our final prospectus filed with the SEC pursuant to Rule 424(b) of the Securities Act and other periodic reports previously filed with the SEC.

Issuer purchases of equity securities

None.

Item 3. Defaults Upon Senior Securities

Not applicable.

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Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Rule 10b5-1 trading plans

During the quarter ended March 31, 2025, none of our directors or officers (as defined in Rule 16a-1 under the Exchange Act) adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" (as those terms are defined in Item 408 of Regulation S-K).

Board composition

Effective May 6, 2025, George Kemble, Ph.D. will transition from his executive officer position as Executive Chairman, and will move into the role of non-executive Chair of the Board. Also, on May 6, 2025, our Board appointed Beth Seidenberg, M.D. to serve as Lead Independent Director of the Board, effective May 6, 2025.

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Item 6. Exhibits


Exhibit Number	Description	Method of Filing

31.1	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002	Filed herewith

31.2	Certification of Principal Financial and Accounting Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002	Filed herewith

32.1	Certification of Principal Executive Officer and Principal Financial and Accounting Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2022	Furnished herewith

101.INS	Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document	Filed herewith

101.SCH	Inline XBRL Taxonomy Extension Schema Document	Filed herewith

101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document	Filed herewith

101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document	Filed herewith

101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document	Filed herewith

101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document	Filed herewith

104	Cover Page Interactive Data File (embedded within the Inline XBRL document)	Filed herewith

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Quarterly Report to be signed on its behalf by the undersigned, thereunto duly authorized.


	SAGIMET BIOSCIENCES, INC.

Date: May 8, 2025	By:	/s/ David Happel
		David Happel
		President and Chief Executive Officer
		(Principal Executive Officer)


Date: May 8, 2025	By:	/s/ Thierry Chauche
		Thierry Chauche
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

Exhibit 31.1

CERTIFICATION PURSUANT TO

RULES 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, David Happel, certify that:

I have reviewed this Form 10-Q for the Quarterly Period Ended March 31, 2025 of Sagimet Biosciences Inc.;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: May 8, 2025	By:	/s/ David Happel
		David Happel
		President and Chief Executive Officer
		(Principal Executive Officer)

Exhibit 31.2

CERTIFICATION PURSUANT TO

RULES 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Thierry Chauche, certify that:

I have reviewed this Form 10-Q for the Quarterly Period Ended March 31, 2025 of Sagimet Biosciences Inc.;

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

[
Date: May 8, 2025	By:	/s/ Thierry Chauche
		Thierry Chauche
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

Exhibit 32.1

CERTIFICATIONS OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER

PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of Sagimet Biosciences Inc. (the “Company”) for the quarterly period ended March 31, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned hereby certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of their knowledge:

(1)

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 8, 2025	By:	/s/ David Happel
		David Happel
		President and Chief Executive Officer
		(Principal Executive Officer)

Date: May 8, 2025	By:	/s/ Thierry Chauche
		Thierry Chauche
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

v3.25.1

Document and Entity Information - shares
3 Months Ended

Mar. 31, 2025

May 02, 2025

Document information

Document Type 10-Q

Document Quarterly Report true

Document Period End Date Mar. 31, 2025

Document Transition Report false

Securities Act File Number 001-41742

Entity Registrant Name Sagimet Biosciences Inc.

Entity Incorporation, State or Country Code DE

Entity Tax Identification Number 20-5991472

Entity Address, Address Line One 155 Bovet Road, 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

Title of 12(b) Security Series A Common Stock,$0.0001 par value per share

Trading Symbol SGMT

Security Exchange Name NASDAQ

Entity Current Reporting Status Yes

Entity Interactive Data Current Yes

Entity Filer Category Non-accelerated Filer

Entity Small Business true

Entity Emerging Growth Company true

Entity Ex Transition Period false

Entity Shell Company false

Entity Central Index Key 0001400118

Current Fiscal Year End Date --12-31

Document Fiscal Year Focus 2025

Document Fiscal Period Focus Q1

Amendment Flag false

Series A Common Stock

Document information

Entity Common Stock, Shares Outstanding 30,674,855

Series B Common Stock

Document information

Entity Common Stock, Shares Outstanding 1,520,490

v3.25.1

CONDENSED BALANCE SHEETS - USD ($)
$ in Thousands

Mar. 31, 2025

Dec. 31, 2024

Current assets:

Cash and cash equivalents $ 64,717 $ 75,840

Short-term marketable securities 79,852 75,410

Prepaid expenses and other current assets 1,503 1,524

Total current assets 146,072 152,774

Long-term marketable securities 7,408

Operating lease right-of-use assets 38 77

Other long-term assets 62

Total assets 146,172 160,259

Current liabilities:

Accounts payable 3,223 1,425

Accrued expenses and other current liabilities 3,918 2,951

Operating lease liabilities 39 78

Total liabilities 7,180 4,454

Commitments and contingencies (Note 6)

Stockholders' equity:

Undesignated preferred stock, $0.0001 per share: 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2025 and December 31, 2024

Additional paid-in capital 452,355 450,883

Accumulated deficit (313,487) (295,311)

Accumulated other comprehensive income 121 230

Total stockholders' equity 138,992 155,805

Total liabilities and stockholders' equity 146,172 160,259

Series A Common Stock

Stockholders' equity:

Common stock 3 3

Series B Common Stock

Stockholders' equity:

Common stock

v3.25.1

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares

Mar. 31, 2025

Dec. 31, 2024

Preferred stock, par value $ 0.0001 $ 0.0001

Preferred stock, shares authorized 10,000,000 10,000,000

Preferred stock, shares issued 0 0

Preferred stock, shares outstanding 0 0

Series A Common Stock

Common stock, par value $ 0.0001 $ 0.0001

Common stock, shares authorized 500,000,000 500,000,000

Common stock, shares issued 30,674,855 30,674,855

Common stock, shares outstanding 30,674,855 30,674,855

Series B Common Stock

Common stock, par value $ 0.0001 $ 0.0001

Common stock, shares authorized 15,000,000 15,000,000

Common stock, shares issued 1,520,490 1,520,490

Common stock, shares outstanding 1,520,490 1,520,490

v3.25.1

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($)
$ in Thousands
3 Months Ended

Mar. 31, 2025

Mar. 31, 2024

Operating expenses:

Research and development expenses $ 15,342 $ 5,262

General and administrative expenses 4,523 3,506

Total operating expenses 19,865 8,768

Loss from operations (19,865) (8,768)

Other income :

Interest income and other, net 1,689 2,139

Total other income 1,689 2,139

Net loss $ (18,176) $ (6,629)

Net loss per share, basic (in dollars per share) $ (0.56) $ (0.23)

Net loss per share, diluted (in dollars per share) $ (0.56) $ (0.23)

Weighted-average shares outstanding, basic (in shares) 32,195,345 29,039,427

Weighted-average shares outstanding, diluted (in shares) 32,195,345 29,039,427

Other comprehensive income:

Net loss $ (18,176) $ (6,629)

Net unrealized loss on marketable securities (109) (23)

Total comprehensive loss $ (18,285) $ (6,652)

v3.25.1

CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)

Common stock

Series A Common Stock

Common stock

Series B Common Stock

Additional paid-in capital

Accumulated deficit

Accumulated Other Comprehensive (Loss) Income

Series A Common Stock

Series B Common Stock

Total

Beginning balance at Dec. 31, 2023 $ 2,000 $ 340,777,000 $ (249,744,000) $ 30,000 $ 91,065,000

Beginning balance (in shares) at Dec. 31, 2023 21,375,402 1,520,490

Increase (Decrease) In Stockholders' Deficit

Sale of Series A common stock, net of issuance costs $ 1,000 104,731,000 104,732,000

Sale of Series A common stock, net of issuance costs (in shares) 9,000,000

Issuance of Series A Common Stock upon exercise of stock options 114,000 114,000

Issuance of Series A Common Stock upon exercise of stock options (in shares) 17,995

Stock-based compensation expense 759,000 759,000

Unrealized loss on marketable securities (23,000) (23,000)

Net loss $ 0 $ 0 0 (6,629,000) 0 (6,629,000)

Ending balance at Mar. 31, 2024 $ 3,000 446,381,000 (256,373,000) 7,000 190,018,000

Ending balance (in shares) at Mar. 31, 2024 30,393,397 1,520,490

Beginning balance at Dec. 31, 2024 $ 3,000 450,883,000 (295,311,000) 230,000 155,805,000

Beginning balance (in shares) at Dec. 31, 2024 30,674,855 1,520,490 30,674,855 1,520,490

Increase (Decrease) In Stockholders' Deficit

Stock-based compensation expense 1,472,000 1,472,000

Unrealized loss on marketable securities (109,000) (109,000)

Net loss $ 0 $ 0 0 (18,176,000) 0 (18,176,000)

Ending balance at Mar. 31, 2025 $ 3,000 $ 452,355,000 $ (313,487,000) $ 121,000 $ 138,992,000

Ending balance (in shares) at Mar. 31, 2025 30,674,855 1,520,490 30,674,855 1,520,490

v3.25.1

CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - Parenthetical
$ in Thousands
3 Months Ended

Mar. 31, 2024

USD ($)

CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY

Issuance costs $ 7,796

v3.25.1

CONDENSED STATEMENTS OF CASH FLOWS - USD ($)
$ in Thousands
3 Months Ended 12 Months Ended

Mar. 31, 2025

Mar. 31, 2024

Dec. 31, 2024

Dec. 31, 2023

Cash flows from operating activities

Net loss $ (18,176) $ (6,629)

Adjustments to reconcile net loss to net cash used in operating activities:

Accretion of discount on marketable securities (535) (193)

Non-cash operating lease expense 39 36

Stock-based compensation expense 1,472 759

Changes in operating assets and liabilities:

Prepaid expenses and other current assets (687) 640

Accounts payable, accrued expenses and other current liabilities 3,390 (782)

Operating lease liabilities (39) (39)

Net cash used in operating activities (14,536) (6,208)

Cash flows from investing activities

Purchases of marketable securities (15,575)

Sales and maturities of marketable securities 18,988 3,000

Net cash provided by investing activities 3,413 3,000

Cash flows from financing activities

Proceeds from sale of Series A common stock, net of issuance costs 105,750

Payment of financing costs (1,018)

Proceeds from exercise of stock options 114

Net cash provided by financing activities 104,846

Net (decrease) increase in cash and cash equivalents $ (11,123) $ 101,638

Cash and cash equivalents at beginning of period 75,840 75,139 75,139

Cash and cash equivalents at end of period 64,717 $ 176,777 $ 75,840 $ 75,139

Supplemental non-cash investing and financing activities:

Deferred financing costs within accounts payable and accrued expenses $ 245

v3.25.1

Description of Business and Basis of Presentation
3 Months Ended

Mar. 31, 2025

Description of Business and Basis of Presentation

Description of Business and Basis of Presentation
SAGIMET BIOSCIENCES INC.
NOTES TO THE CONDENSED FINANCIAL STATEMENTS (unaudited)
1. Description of Business and Basis of Presentation
Description of business
Sagimet Biosciences Inc. (the Company), a Delaware corporation headquartered in San Mateo, California, is a clinical-stage biopharmaceutical company developing novel therapeutics called fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. The Company’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for metabolic dysfunction-associated steatohepatitis (MASH), acne, and select forms of cancer. FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet’s second FASN inhibitor, TVB-3567, a potent and selective small molecule FASN inhibitor, received IND clearance in March 2025, allowing initiation of a first-in-human Phase 1 clinical trial in acne. The Company’s license partner, Ascletis BioScience Co. Ltd. (Ascletis), is currently testing denifanstat in a Phase 3 trial in moderate to severe acne vulgaris and in a Phase 3 trial in recurrent glioblastoma multiforme (GBM) in combination with bevacizumab, both in China.
Basis of presentation
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted (GAAP) in the United States. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB).
These unaudited interim financial statements and accompanying notes should be read in conjunction with the Company’s annual financial statements and the notes thereto included in the Company’s Form 10-K, as filed with the Securities and Exchange Commission (SEC) on March 12, 2025. The accompanying interim financial statements as of March 31, 2025 and for the three months ended March 31, 2025 and 2024 are unaudited but include all adjustments that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2024 have been derived from the audited financial statements as of that date.
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Such estimates include accruals of research and development expenses, accrued costs for services rendered under agreements with third-party contract research organizations (CROs) and stock option valuations and stock-based compensation. On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates.
Emerging growth company status
The Company is an emerging growth company (EGC) as defined in the Jumpstart Our Business Startups Acts of 2012, as amended (the JOBS Act), and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. The Company may take advantage of these exemptions until it is no longer an EGC under Section 107 of the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting standards. As a result of this election, the Company’s financial statements may not be comparable to those issued by companies that comply with the effective dates pursuant to public company FASB standards.
Liquidity
The accompanying unaudited financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. As of March 31, 2025, the Company has relied on public and private equity and debt financings and proceeds from licensing arrangements to fund its operations. The Company has incurred recurring losses and negative cash flows from operations since inception, and, as of March 31, 2025, had an accumulated deficit of $313.5 million and cash, cash equivalents and marketable securities of $144.6 million. The Company expects to incur additional losses and negative cash flows from operations for the foreseeable future.
In July and August 2023, the Company completed its initial public offering (IPO) and, inclusive of the partial exercise of the underwriters’ overallotment option, the Company sold an aggregate of 6,026,772 shares of Series A common stock at a public offering price of $16.00 per share and received $86.2 million in net proceeds. In January 2024, the Company completed a follow-on offering whereby it sold 9,000,000 shares of its Series A common stock at a price of $12.50 per share and received $104.7 million in proceeds, net of issuance costs of $7.8 million.
In August 2024, the Company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. to establish an at-the-market offering (ATM Offering) through which the Company may sell, from time to time at its sole discretion, up to $75.0 million shares of its Series A common stock. There were no sales under the ATM Offering during the three months ended March 31, 2025.
The Company expects that its cash, cash equivalents and marketable securities as of March 31, 2025 will be sufficient to fund the Company’s operating expenses for at least the next 12 months from the issuance of these financial statements. In the future, the Company will need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or issue debt financing, may provide additional liquidity in the future, however these actions are not solely within the control of the Company and the Company is unable to predict the outcome of these actions to generate the liquidity ultimately required.

v3.25.1

Summary of significant accounting policies
3 Months Ended

Mar. 31, 2025

Summary of significant accounting policies

Summary of significant accounting policies
2. Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited financial statements and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 12, 2025. Since the date of those audited financial statements, there have been no material changes to the Company’s significant accounting policies.
Net loss per share attributable to common stockholders
Basic and diluted net loss per share is computed using the two-class method required for multiple classes of common stock and participating securities. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders for all periods presented. Basic net loss per common share attributable to common stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share attributable to common stockholders’ calculation, common stock options, restricted stock units and common stock warrants are considered to be potentially dilutive securities. As the Company has reported a net loss for the periods presented, basic and diluted net loss per share attributable to common stockholders is the same as all potentially dilutive securities would have an anti-dilutive impact.
The following table presents the calculation of basic and diluted net loss per share for the three months ended March 31, 2025 and 2024 (in thousands, except share and per share data):

Three Months Ended March 31,

2025

2024
Numerator:

Net loss

$
(18,176)

$
(6,629)
Denominator:

Weighted-average shares of Series A and Series B common stock outstanding, basic and diluted

32,195,345

29,039,427
Net loss per share of Series A and Series B common stock outstanding, basic and diluted

$
(0.56)

$
(0.23)

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of Series A and Series B common stock outstanding, as their effect would have been anti-dilutive:

Three Months Ended March 31,


2025

2024
Options to purchase Series A common stock

5,494,659

3,518,803
Warrants to purchase Series A common stock

1,000

1,000
Unvested restricted stock units

1,098,399

1,125,840
Total

6,594,058

4,645,643

New accounting pronouncements not yet adopted
The Company considers the applicability and impact of all ASUs. ASUs not discussed below were assessed and either determined to be not applicable or expected to have minimal impact on the Company’s financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires public business entities to disclose, for interim and annual reporting periods, additional information about certain income statement expense categories. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently evaluating the impact of the adoption of this standard on its financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures, a final standard on improvements to income tax disclosures. The standard requires disaggregated information about a reporting entity's effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions and applies to all entities subject to income taxes. The new standard is effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of the adoption of this standard on its disclosures and will adopt the ASU for its Annual Report on Form 10-K for the year ended December 31, 2025.

v3.25.1

Fair value measurements and fair value of financial instruments
3 Months Ended

Mar. 31, 2025

Fair value measurements and fair value of financial instruments

Fair value measurements and fair value of financial instruments
3.
Fair Value Measurements and Fair Value of Financial Instruments
The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:
Level 1 - Quoted prices in active markets for identical assets or liabilities.
Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
As of March 31, 2025 and December 31, 2024, financial assets measured at fair value on a recurring basis consisted of cash equivalents and marketable securities. Cash equivalents consist primarily of money market funds and other investments that are readily convertible into cash and have maturities of three months or less at the time of acquisition. The fair value of cash equivalents was $64.2 million and $75.3 million as of March 31, 2025 and December 31, 2024, respectively. The Company considers marketable securities with maturities greater than three months at the time of acquisition to be available-for-sale securities. The fair value of available-for-sale securities was $79.9 million and $82.8 million as of March 31, 2025 and December 31, 2024, respectively. These available-for-sale securities have expected maturities ranging from 0.03 to 10.7 months. The fair value of marketable securities, which are Level 2 financial instruments, is based upon market prices quoted on the last day of the fiscal period or other observable market inputs. The Company obtains pricing information from its investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker-dealer quotes, bids and/or offers.
The Company evaluates securities with unrealized losses, if any, to determine whether the decline in fair value has resulted from credit loss or other factors, including various qualitative factors. As of March 31, 2025, the Company has not recognized any impairment or credit losses on the Company’s available-for-sale securities. While the Company classifies these securities as available-for-sale, the Company does not intend to sell its investments and based on its current plans, the Company currently believes it has the ability to hold these investments until maturity.
The carrying values of the Company’s accounts payable and accrued expenses and other current liabilities approximate their fair values due to the short-term nature of these liabilities.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
The Company’s Level 3 liabilities that are measured at fair value on a recurring basis consist of the Series A common stock warrant liability related to the warrant to purchase 1,000 shares of Series A common stock with an exercise price of $69.94 per share and an expiration date of July 18, 2026, the third anniversary date of the closing of the Company’s IPO. The fair value of Series A common stock warrant liability was immaterial as of March 31, 2025 and December 31, 2024, as well as the change in fair value during the three months ended March 31, 2025 and 2024. There were no transfers within the hierarchy during the periods presented.
The following tables set forth the Company’s financial assets that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):



March 31, 2025

Valuation

Amortized

Unrealized

Unrealized


Hierarchy

cost

Gains

Losses

Fair Value
Assets

Cash equivalents:

Money market funds

Level 1

$
64,201

$
—

$
—

$
64,201
Total cash equivalents

64,201

—

—

64,201
Short-term marketable securities:

Commercial paper


Level 2

20,988


4


(2)


20,990
Corporate debt securities

Level 2

4,465

2

—

4,467
U.S. Treasury securities

Level 2

39,924

109

—

40,033
Agency securities

Level 2

11,868

—

(2)

11,866
Asset-backed securities

Level 2

2,486

10

—

2,496
Total short-term marketable securities

79,731

125

(4)

79,852
Total cash equivalents and marketable securities

$
143,932

$
125

$
(4)

$
144,053

December 31, 2024

Valuation

Amortized

Unrealized

Unrealized


Hierarchy

cost

Gains

Losses

Fair Value
Assets

Cash equivalents:

Money market funds

Level 1

$
72,800

$
—

$
—

$
72,800
U.S. Treasury securities

Level 2

2,477

—

—

2,477
Total cash equivalents

75,277

—

—

75,277
Short-term marketable securities:

Commercial paper


Level 2

14,447


25


(1)


14,471
Corporate debt securities

Level 2

6,909

7

—

6,916
U.S. Treasury securities

Level 2

27,493

123

—

27,616
Agency securities

Level 2

21,345

12

(2)

21,355
Asset-backed securities

Level 2

5,030

22

—

5,052
Total short-term marketable securities

75,224

189

(3)

75,410
Long-term marketable securities:

U.S. Treasury securities

Level 2

4,884

36

—

4,920
Asset-backed securities

Level 2

2,480

8

—

2,488
Total long-term marketable securities

7,364

44

—

7,408
Total cash equivalents and marketable securities

$
157,865

$
233

$
(3)

$
158,095

v3.25.1

Prepaid expenses and other current assets
3 Months Ended

Mar. 31, 2025

Prepaid expenses and other current assets

Prepaid expenses and other current assets
4.
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):

As of

March 31,

December 31,

2025

2024
Prepaid clinical costs

$
226

$
436
Prepaid research and development costs

112

48
Prepaid insurance

277

577
Deferred financing costs

625

306
Other

263

157
Total prepaid expenses and other current assets

$
1,503

$
1,524

v3.25.1

Accrued expenses and other current liabilities
3 Months Ended

Mar. 31, 2025

Accrued expenses and other current liabilities

Accrued expenses and other current liabilities
5.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):

As of

March 31,

December 31,

2025

2024
Accrued payroll-related costs

$
423

$
1,358
Accrued clinical costs

665

528
Accrued research and development costs

1,829

516
Accrued general and administrative costs

938

544
Accrued offering costs

47

—
Other

16

5
Total accrued expenses and other current liabilities

$
3,918

$
2,951

v3.25.1

Commitments and contingencies
3 Months Ended

Mar. 31, 2025

Commitments and contingencies.

Commitments and contingencies
6.
Commitments and Contingencies
License and other agreements
Ascletis BioScience Co. Ltd
In January 2019, the Company entered into a license agreement that became effective in February 2019 with Ascletis BioScience Co. Ltd. (Ascletis), a subsidiary of Ascletis Pharma Inc. (Ascletis Pharma), a biotechnology company incorporated in the Cayman Islands and headquartered in Hangzhou, China. Ascletis Pharma, through a subsidiary, was the lead investor in the Company’s Series E redeemable convertible preferred stock financing in February 2019. The parties entered into this agreement with the intention to develop, manufacture, and commercialize the Company’s proprietary FASN inhibitor, denifanstat, which Ascletis refers to as ASC40. Under the terms of the license agreement, the Company granted Ascletis and its affiliates an exclusive, royalty-bearing sublicensable right and license under the Company’s intellectual property to develop, manufacture, commercialize and otherwise exploit denifanstat and other products containing denifanstat-related compounds in Greater China, consisting of the People’s Republic of China, Hong Kong, Macau and Taiwan.
The Company is eligible to receive development and commercial milestone payments from Ascletis in aggregate of up to $122.0 million as well as tiered royalties ranging from percentages in the high single digits to mid-teens on future net sales of denifanstat in Greater China. The license and the research and development services components of this license agreement are representative of a relationship with a customer, and therefore, the Company evaluated the license agreement under the provisions of ASC 606, Revenue from Contracts with Customers. The developmental and commercial event-based milestone payments represent variable consideration, and the Company used the most likely amount method to estimate this variable consideration because the potential milestone payment is a binary event, as the Company will either receive the milestone payment or it will not. Given the high degree of uncertainty around achievement of these milestones, the Company determined the milestone amounts to be fully constrained and will not recognize revenue until the uncertainty associated with these payments is resolved. Any consideration related to royalties will be recognized if and when the related sales occur. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur.
In July 2023, the Company entered into an Assignment and Assumption Agreement with Ascletis and Ascletis’ affiliate Gannex Pharma Co., Ltd. (Gannex) under which Ascletis, while remaining responsible for performance under the license agreement, assigned all of its rights and obligations under the license agreement to Gannex and Gannex assumed such rights and obligations, effective as of October 2019.
Facility Lease Agreement
On March 12, 2019, the Company executed a 38-month non-cancelable operating lease agreement for 3,030 square feet of office space for its headquarters facility in San Mateo, California, which commenced April 1, 2019. The lease provides for monthly lease payments of approximately $12,000 with annual increases. In December, 2021, the lease agreement was amended to extend the term of the lease through June 2024; in April 2024, the Company amended the lease agreement to (i) extend the lease through June 30, 2025 and (ii) increase the monthly lease payment to approximately $13,000 beginning on July 1, 2024, which resulted in an increase in the Company’s operating lease right-of-use asset and corresponding operating lease liability of $0.1 million on the amendment date.
Operating lease costs were $39,000 and $37,000 for the three months ended March 31, 2025, and 2024, respectively.
Guarantees and indemnifications
In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. As of March 31, 2025, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.
Legal Proceedings
From time to time, the Company may become involved in various legal proceedings that arise in the ordinary course of its business. The Company records a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Significant judgment by the Company is required to determine both probability and the estimated amount. The Company is not party to any material legal proceedings as of March 31, 2025.

v3.25.1

Stock-based compensation
3 Months Ended

Mar. 31, 2025

Stock-based compensation

Stock-based compensation
7.
Stock-Based Compensation
The 2023 Stock Option and Incentive Plan (2023 Plan) was adopted by the board of directors, approved by the Company’s stockholders on July 4, 2023, and became effective on July 13, 2023, replacing the 2017 Equity Incentive Plan. The number of shares initially reserved for issuance under the 2023 Plan was 2,585,968. The number of shares will automatically increase each January 1, by (i) 4% of the outstanding number of shares of the Company’s Series A common stock on the immediately preceding December 31 or (ii) a lesser number of shares as determined by the compensation committee of the board of directors. In accordance with the 2023 Plan, the shares reserved for issuance automatically increased by 855,016 shares on January 1, 2024, and by 1,226,994 shares on January 1, 2025. As of March 31, 2025, the aggregate maximum number of shares reserved for issuance under the 2023 Plan was 4,667,978, of which 1,670,598 shares were available for future grant. Option grants issued under the 2023 Plan are exercisable for up to 10 years from the date of issuance.
In March 2024, the Company established a pool of 1,000,000 shares of Series A common stock (Inducement Pool) from which equity grants in the form of options and restricted stock units may be issued as inducement for new employees to accept employment offers from the Company or for individuals returning to employment after a bona fide period of non-employment with the Company. Inducement Pool grants are granted outside of the 2023 Plan and do not require approval from the Company’s stockholders pursuant to the Nasdaq inducement grant exception in accordance with Nasdaq Listing Rule 5635(c)(4). In February 2025, the Company increased the number of shares available for issuance by 300,000 shares, increasing the total number of shares available for issuance under the Inducement Pool to 1,300,000 shares. As of March 31, 2025, 404,017 shares were available for future grants from the Inducement Pool.
Total stock-based compensation recorded in the condensed statements of operations and comprehensive loss related to stock options and restricted stock units for employees and non-employees was as follows (in thousands):


Three Months Ended March 31,


2025

2024

Stock options

$
1,223

$
449

Restricted stock units

249

310

Total stock-based compensation expense

$
1,472

$
759

Included in:

General and administrative expense

$
1,248

$
513

Research and development expense

224

246

Total stock-based compensation expense

$
1,472

$
759

Stock options

The Company grants stock options which consist of (i) time-based options, which vest and become exercisable, subject to the participant’s continued employment or service through the applicable vesting date and (ii) performance-based options, which vest based on performance measures against predetermined objectives that include successful completion of qualified equity offerings or announced
topline results for clinical trials and positive clinical results over a specified performance period. The Company’s time-based options have various vesting schedules that range from vesting immediately to vesting over a four-year period.
The following table summarizes stock option activity for the three months ended March 31, 2025 (in thousands, except share and per share data):






Weighted-


Number of

Average

Shares

Weighted-

Remaining

Underlying

Average

Contractual

Aggregate

Outstanding

Exercise

Term

Intrinsic

Options

Price

(in Years)

Value (1)
Outstanding, January 1, 2025

4,462,517

$
6.58

7.4

$
619
Granted

1,032,289

4.71

Forfeited/expired

(147)

23.05

Outstanding, March 31, 2025 ⁽²⁾

5,494,659

$
6.23

7.7

$
26
Vested and expected to vest, March 31, 2025

5,494,659

$
6.23

7.7

$
26
Exercisable at March 31, 2025

2,741,368

$
7.06

6.2

$
—
____________

(1) Aggregate intrinsic value represents the difference between the fair value of the Company’s Series A common stock on the last day of the fiscal period and the exercise price, multiplied by the number of options outstanding.
(2) Includes 492,729 performance-based options with a weighted-average exercise price of $6.42, all of which were fully vested and exercisable.
During the three months ended March 31, 2025 and 2024, the weighted average grant-date fair value per share of stock options granted was $3.71 and $4.34, respectively. The total intrinsic value of stock options exercised during the three months ended March 31, 2024, was $0.1 million. Additionally, during the three months ended March 31, 2024, cash received from the exercise of stock options was approximately $0.1 million.
As of March 31, 2025, there was $11.1 million of unrecognized compensation expense, which is expected to be recognized over a remaining weighted-average period of 2.7 years.
Restricted stock units
The Company’s restricted stock units generally vest over a four-year period in equal amounts on an annual basis, provided the employee remains continuously employed with the Company. The fair value of the restricted stock units is equal to the closing price of the Company’s Series A common stock on the grant date.
The following table summarizes restricted stock unit activity:

Weighted-Average


Restricted

Grant Date


Stock Units

Fair Value
Outstanding, January 1, 2025

844,382

$
2.96
Granted

254,017

4.71
Outstanding, March 31, 2025

1,098,399

$
3.36

As of March 31, 2025, the total unrecognized compensation expense related to unvested restricted stock units was $3.1 million, which is expected to be recognized over a remaining weighted-average period of 2.9 years.
Valuation assumptions
The fair value of each stock option granted was estimated on the date of grant using the Black-Scholes option pricing model using the following assumptions:


Three Months Ended March 31,

2025

2024
Expected volatility

95.0
%

96.0
%
Risk-free interest rate

4.3
%

4.1
%
Dividend yield

—

—

Expected term (in years)

6.0

6.1

The expected term is determined using the simplified method, which represents the average of the contractual term of the options and the weighted-average expected vesting period. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the option. The expected stock volatility rate is based on the volatility rates of comparable publicly held companies over a period equal to the expected term of the option. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends to stockholders and has no current intentions to pay cash dividends.

Employee stock purchase plan

The 2023 Employee Stock Purchase Plan (the ESPP) was adopted by the board of directors in July 2023 with an initial total of 215,497 shares of Series A common stock reserved for issuance. Under the ESPP plan, the amount of shares reserved automatically increases each January 1 through January 1, 2033, by the least of (i) 215,497 shares of Series A common stock, (ii) 1% of the outstanding number of shares of the Company’s Series A common stock on the immediately preceding December 31 or (iii) such lesser number of shares of Series A common stock as determined by the administrator of the ESPP. In accordance with the ESPP, the shares reserved for issuance automatically increased by 213,754 shares on January 1, 2024, and by 215,497 shares on January 1, 2025. As of March 31, 2025, the aggregate maximum number of shares reserved for issuance under the ESPP was 644,748. No shares of Series A common stock have been issued under the ESPP to date.

v3.25.1

Related Party Transactions
3 Months Ended

Mar. 31, 2025

Related Party Transactions

Related Party Transactions
8.
Related Party Transactions
Jinzi J. Wu, Ph.D., a member of the Company’s board of directors until June 2024, founded and serves as the chief executive officer of Ascletis, Gannex, and Ascletis Pharma.

During the three months ended March 31, 2024, the Company recognized $96,000 of expenses under the Ascletis license agreement, inclusive of manufacturing services fees charged by Ascletis pursuant to the manufacturing agreement with Ascletis which falls under the license agreement. These expenses are recorded in research and development expense in the statements of operations and comprehensive loss.

v3.25.1

Segment Reporting
3 Months Ended

Mar. 31, 2025

Segment Reporting

Segment Reporting
9.
Segment Reporting
Operating segments are defined as components of an entity about which discrete financial information is evaluated regularly by the chief operating decision maker (CODM) in deciding how to allocate resources and assess performance. The Company operates and manages its business as one business segment, which is development and commercialization of therapeutics for the treatment of MASH and other diseases where FASN plays a pathogenic role. Accordingly, the Company has one reportable segment. The Company has a single management team that reports to the Chief Executive Officer, the Company's CODM, who comprehensively manages the entire Company. The accounting policies of the segment are the same as those described in the summary of significant accounting policies.

When evaluating the Company’s financial performance, the CODM is regularly provided with more detailed expense information than what is included in the Company’s statements of operations and comprehensive loss. The CODM uses net loss, as reported in the statements of operations and comprehensive loss, in evaluating the performance of the segment. Decisions regarding resource allocation are made primarily during the annual budget planning process and reallocated as needed throughout the year. The measure of segment assets is reported on the balance sheets as total assets.

The following table shows a reconciliation of the Company’s net loss, including the significant expense categories regularly provided to and reviewed by the CODM, as computed under U.S. GAAP, to the Company’s total net loss in the statements of operations and comprehensive loss, for the three months ended March 31, 2025, and 2024 (in thousands):

Three Months Ended March 31,

2025

2024
External research and development expenses

14,170

4,191
External general and administrative expenses

2,252

2,097
Personnel costs

1,951

1,478
Stock-based compensation

1,472

759
Other segment items ⁽¹⁾

(1,669)

(1,896)
Segment net loss

$
18,176

$
6,629

(1) Other segment items consist of (i) interest and other income, net and (ii) other internal operating research and development expenses.

v3.25.1

Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended

Mar. 31, 2025

Mar. 31, 2024

Pay vs Performance Disclosure

Net Income (Loss) $ (18,176) $ (6,629)

v3.25.1

Insider Trading Arrangements
3 Months Ended

Mar. 31, 2025

Trading Arrangements, by Individual

Rule 10b5-1 Arrangement Adopted false

Non-Rule 10b5-1 Arrangement Adopted false

Rule 10b5-1 Arrangement Terminated false

Non-Rule 10b5-1 Arrangement Terminated false

v3.25.1

Summary of significant accounting policies (Policies)
3 Months Ended

Mar. 31, 2025

Summary of significant accounting policies

Basis of presentation
Basis of presentation
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted (GAAP) in the United States. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB).
These unaudited interim financial statements and accompanying notes should be read in conjunction with the Company’s annual financial statements and the notes thereto included in the Company’s Form 10-K, as filed with the Securities and Exchange Commission (SEC) on March 12, 2025. The accompanying interim financial statements as of March 31, 2025 and for the three months ended March 31, 2025 and 2024 are unaudited but include all adjustments that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2024 have been derived from the audited financial statements as of that date.
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Such estimates include accruals of research and development expenses, accrued costs for services rendered under agreements with third-party contract research organizations (CROs) and stock option valuations and stock-based compensation. On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates.

Emerging growth company status
Emerging growth company status
The Company is an emerging growth company (EGC) as defined in the Jumpstart Our Business Startups Acts of 2012, as amended (the JOBS Act), and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. The Company may take advantage of these exemptions until it is no longer an EGC under Section 107 of the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting standards. As a result of this election, the Company’s financial statements may not be comparable to those issued by companies that comply with the effective dates pursuant to public company FASB standards.

Liquidity
Liquidity
The accompanying unaudited financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. As of March 31, 2025, the Company has relied on public and private equity and debt financings and proceeds from licensing arrangements to fund its operations. The Company has incurred recurring losses and negative cash flows from operations since inception, and, as of March 31, 2025, had an accumulated deficit of $313.5 million and cash, cash equivalents and marketable securities of $144.6 million. The Company expects to incur additional losses and negative cash flows from operations for the foreseeable future.
In July and August 2023, the Company completed its initial public offering (IPO) and, inclusive of the partial exercise of the underwriters’ overallotment option, the Company sold an aggregate of 6,026,772 shares of Series A common stock at a public offering price of $16.00 per share and received $86.2 million in net proceeds. In January 2024, the Company completed a follow-on offering whereby it sold 9,000,000 shares of its Series A common stock at a price of $12.50 per share and received $104.7 million in proceeds, net of issuance costs of $7.8 million.
In August 2024, the Company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. to establish an at-the-market offering (ATM Offering) through which the Company may sell, from time to time at its sole discretion, up to $75.0 million shares of its Series A common stock. There were no sales under the ATM Offering during the three months ended March 31, 2025.
The Company expects that its cash, cash equivalents and marketable securities as of March 31, 2025 will be sufficient to fund the Company’s operating expenses for at least the next 12 months from the issuance of these financial statements. In the future, the Company will need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or issue debt financing, may provide additional liquidity in the future, however these actions are not solely within the control of the Company and the Company is unable to predict the outcome of these actions to generate the liquidity ultimately required.

Net loss per share attributable to common stockholders
Net loss per share attributable to common stockholders
Basic and diluted net loss per share is computed using the two-class method required for multiple classes of common stock and participating securities. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders for all periods presented. Basic net loss per common share attributable to common stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share attributable to common stockholders’ calculation, common stock options, restricted stock units and common stock warrants are considered to be potentially dilutive securities. As the Company has reported a net loss for the periods presented, basic and diluted net loss per share attributable to common stockholders is the same as all potentially dilutive securities would have an anti-dilutive impact.
The following table presents the calculation of basic and diluted net loss per share for the three months ended March 31, 2025 and 2024 (in thousands, except share and per share data):

Three Months Ended March 31,

2025

2024
Numerator:

Net loss

$
(18,176)

$
(6,629)
Denominator:

Weighted-average shares of Series A and Series B common stock outstanding, basic and diluted

32,195,345

29,039,427
Net loss per share of Series A and Series B common stock outstanding, basic and diluted

$
(0.56)

$
(0.23)

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of Series A and Series B common stock outstanding, as their effect would have been anti-dilutive:

Three Months Ended March 31,


2025

2024
Options to purchase Series A common stock

5,494,659

3,518,803
Warrants to purchase Series A common stock

1,000

1,000
Unvested restricted stock units

1,098,399

1,125,840
Total

6,594,058

4,645,643

Accounting pronouncements
New accounting pronouncements not yet adopted
The Company considers the applicability and impact of all ASUs. ASUs not discussed below were assessed and either determined to be not applicable or expected to have minimal impact on the Company’s financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires public business entities to disclose, for interim and annual reporting periods, additional information about certain income statement expense categories. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently evaluating the impact of the adoption of this standard on its financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures, a final standard on improvements to income tax disclosures. The standard requires disaggregated information about a reporting entity's effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions and applies to all entities subject to income taxes. The new standard is effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of the adoption of this standard on its disclosures and will adopt the ASU for its Annual Report on Form 10-K for the year ended December 31, 2025.

v3.25.1

Summary of significant accounting policies (Tables)
3 Months Ended

Mar. 31, 2025

Summary of significant accounting policies

Schedule of basic and diluted loss per share

Three Months Ended March 31,

2025

2024
Numerator:

Net loss

$
(18,176)

$
(6,629)
Denominator:

Weighted-average shares of Series A and Series B common stock outstanding, basic and diluted

32,195,345

29,039,427
Net loss per share of Series A and Series B common stock outstanding, basic and diluted

$
(0.56)

$
(0.23)

Schedule of potentially dilutive securities

Three Months Ended March 31,


2025

2024
Options to purchase Series A common stock

5,494,659

3,518,803
Warrants to purchase Series A common stock

1,000

1,000
Unvested restricted stock units

1,098,399

1,125,840
Total

6,594,058

4,645,643

v3.25.1

Fair value measurements and fair value of financial instruments (Tables)
3 Months Ended

Mar. 31, 2025

Fair value measurements and fair value of financial instruments

Schedule of marketable securities, available-for-sale
The following tables set forth the Company’s financial assets that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):



March 31, 2025

Valuation

Amortized

Unrealized

Unrealized


Hierarchy

cost

Gains

Losses

Fair Value
Assets

Cash equivalents:

Money market funds

Level 1

$
64,201

$
—

$
—

$
64,201
Total cash equivalents

64,201

—

—

64,201
Short-term marketable securities:

Commercial paper


Level 2

20,988


4


(2)


20,990
Corporate debt securities

Level 2

4,465

2

—

4,467
U.S. Treasury securities

Level 2

39,924

109

—

40,033
Agency securities

Level 2

11,868

—

(2)

11,866
Asset-backed securities

Level 2

2,486

10

—

2,496
Total short-term marketable securities

79,731

125

(4)

79,852
Total cash equivalents and marketable securities

$
143,932

$
125

$
(4)

$
144,053

December 31, 2024

Valuation

Amortized

Unrealized

Unrealized


Hierarchy

cost

Gains

Losses

Fair Value
Assets

Cash equivalents:

Money market funds

Level 1

$
72,800

$
—

$
—

$
72,800
U.S. Treasury securities

Level 2

2,477

—

—

2,477
Total cash equivalents

75,277

—

—

75,277
Short-term marketable securities:

Commercial paper


Level 2

14,447


25


(1)


14,471
Corporate debt securities

Level 2

6,909

7

—

6,916
U.S. Treasury securities

Level 2

27,493

123

—

27,616
Agency securities

Level 2

21,345

12

(2)

21,355
Asset-backed securities

Level 2

5,030

22

—

5,052
Total short-term marketable securities

75,224

189

(3)

75,410
Long-term marketable securities:

U.S. Treasury securities

Level 2

4,884

36

—

4,920
Asset-backed securities

Level 2

2,480

8

—

2,488
Total long-term marketable securities

7,364

44

—

7,408
Total cash equivalents and marketable securities

$
157,865

$
233

$
(3)

$
158,095

v3.25.1

Prepaid expenses and other current assets (Tables)
3 Months Ended

Mar. 31, 2025

Prepaid expenses and other current assets

Schedule of prepaid expenses and other current assets
Prepaid expenses and other current assets consisted of the following (in thousands):

As of

March 31,

December 31,

2025

2024
Prepaid clinical costs

$
226

$
436
Prepaid research and development costs

112

48
Prepaid insurance

277

577
Deferred financing costs

625

306
Other

263

157
Total prepaid expenses and other current assets

$
1,503

$
1,524

v3.25.1

Accrued expenses and other current liabilities (Tables)
3 Months Ended

Mar. 31, 2025

Accrued expenses and other current liabilities

Schedule of accrued expenses and other current liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):

As of

March 31,

December 31,

2025

2024
Accrued payroll-related costs

$
423

$
1,358
Accrued clinical costs

665

528
Accrued research and development costs

1,829

516
Accrued general and administrative costs

938

544
Accrued offering costs

47

—
Other

16

5
Total accrued expenses and other current liabilities

$
3,918

$
2,951

v3.25.1

Stock-based compensation (Tables)
3 Months Ended

Mar. 31, 2025

Stock-based compensation

Schedule of stock-based compensation expense


Three Months Ended March 31,


2025

2024

Stock options

$
1,223

$
449

Restricted stock units

249

310

Total stock-based compensation expense

$
1,472

$
759

Included in:

General and administrative expense

$
1,248

$
513

Research and development expense

224

246

Total stock-based compensation expense

$
1,472

$
759

Schedule of option activity transactions
The following table summarizes stock option activity for the three months ended March 31, 2025 (in thousands, except share and per share data):






Weighted-


Number of

Average

Shares

Weighted-

Remaining

Underlying

Average

Contractual

Aggregate

Outstanding

Exercise

Term

Intrinsic

Options

Price

(in Years)

Value (1)
Outstanding, January 1, 2025

4,462,517

$
6.58

7.4

$
619
Granted

1,032,289

4.71

Forfeited/expired

(147)

23.05

Outstanding, March 31, 2025 ⁽²⁾

5,494,659

$
6.23

7.7

$
26
Vested and expected to vest, March 31, 2025

5,494,659

$
6.23

7.7

$
26
Exercisable at March 31, 2025

2,741,368

$
7.06

6.2

$
—
____________

(1) Aggregate intrinsic value represents the difference between the fair value of the Company’s Series A common stock on the last day of the fiscal period and the exercise price, multiplied by the number of options outstanding.
(2) Includes 492,729 performance-based options with a weighted-average exercise price of $6.42, all of which were fully vested and exercisable.

Schedule of restricted stock unit activity

Weighted-Average


Restricted

Grant Date


Stock Units

Fair Value
Outstanding, January 1, 2025

844,382

$
2.96
Granted

254,017

4.71
Outstanding, March 31, 2025

1,098,399

$
3.36

Schedule of fair value assumptions


Three Months Ended March 31,

2025

2024
Expected volatility

95.0
%

96.0
%
Risk-free interest rate

4.3
%

4.1
%
Dividend yield

—

—

Expected term (in years)

6.0

6.1

v3.25.1

Segment Reporting (Tables)
3 Months Ended

Mar. 31, 2025

Segment Reporting

Summary of net loss reconciliation

Three Months Ended March 31,

2025

2024
External research and development expenses

14,170

4,191
External general and administrative expenses

2,252

2,097
Personnel costs

1,951

1,478
Stock-based compensation

1,472

759
Other segment items ⁽¹⁾

(1,669)

(1,896)
Segment net loss

$
18,176

$
6,629

(1) Other segment items consist of (i) interest and other income, net and (ii) other internal operating research and development expenses.

v3.25.1

Description of Business and Basis of Presentation (Details) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 2 Months Ended 3 Months Ended

Aug. 31, 2024

Jan. 31, 2024

Aug. 31, 2023

Mar. 31, 2025

Mar. 31, 2024

Dec. 31, 2024

Organization and description of business

Accumulated deficit $ 313,487 $ 295,311

Cash and cash equivalents and marketable securities 144,600

Issuance costs $ 7,796

Series A Common Stock

Organization and description of business

Shares issued (in shares) 9,000,000 6,026,772

Share price (in dollars per share) $ 12.5 $ 16

Net proceeds $ 104,700 $ 86,200

Issuance costs $ 7,800

At market arrangement

Organization and description of business

Net proceeds $ 0

Maximum value of sales under the arrangement $ 75,000

v3.25.1

Summary of significant accounting policies - EPS (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended

Mar. 31, 2025

Mar. 31, 2024

Numerator:

Net loss $ (18,176) $ (6,629)

Denominator:

Weighted-average shares outstanding, basic (in shares) 32,195,345 29,039,427

Weighted-average shares outstanding, diluted (in shares) 32,195,345 29,039,427

Net loss per share, basic (in dollars per share) $ (0.56) $ (0.23)

Net loss per share, diluted (in dollars per share) $ (0.56) $ (0.23)

v3.25.1

Summary of significant accounting policies - Dilutive (Details) - shares
3 Months Ended

Mar. 31, 2025

Mar. 31, 2024

Antidilutive securities

Potentially dilutive securities (in shares) 6,594,058 4,645,643

Stock options

Antidilutive securities

Potentially dilutive securities (in shares) 5,494,659 3,518,803

Warrants

Antidilutive securities

Potentially dilutive securities (in shares) 1,000 1,000

Restricted stock units

Antidilutive securities

Potentially dilutive securities (in shares) 1,098,399 1,125,840

v3.25.1

Fair value measurements and fair value of financial instruments - Warrants (Details) - Series A common stock warrant

Mar. 31, 2025

$ / shares

shares

Redeemable Convertible Preferred Stock Warrant Liability

Warrants issued (in shares) | shares 1,000

Exercise price of warrant (in dollars per share) | $ / shares $ 69.94

v3.25.1

Prepaid expenses and other current assets (Details) - USD ($)
$ in Thousands

Mar. 31, 2025

Dec. 31, 2024

Prepaid expenses and other current assets

Prepaid clinical expenses $ 226 $ 436

Prepaid research and development 112 48

Prepaid insurance 277 577

Deferred financing costs 625 306

Other 263 157

Total prepaid expenses and other current assets $ 1,503 $ 1,524

v3.25.1

Accrued expenses and other current liabilities (Details) - USD ($)
$ in Thousands

Mar. 31, 2025

Dec. 31, 2024

Accrued expenses and other current liabilities

Accrued payroll-related costs $ 423 $ 1,358

Accrued clinical costs 665 528

Accrued research and development costs 1,829 516

Accrued general and administrative costs 938 544

Accrued offering costs 47

Other 16 5

Total accrued expenses and other current liabilities $ 3,918 $ 2,951

v3.25.1

Commitments and contingencies - Licenses (Details)
$ in Millions
3 Months Ended

Mar. 31, 2025

USD ($)

Commitments and contingencies.

Maximum eligible development and commercial milestone payments $ 122.0

v3.25.1

Commitments and contingencies - Lease (Details)
$ in Thousands
1 Months Ended 3 Months Ended

Mar. 12, 2019

USD ($)

ft²

Apr. 30, 2024

USD ($)

Mar. 31, 2025

USD ($)

Mar. 31, 2024

USD ($)

Commitments and contingencies.

Operating lease term 38 months

Rented area (in square feet) | ft² 3,030

Monthly lease payments $ 12 $ 13

Change in operating lease liability $ 100

Operating lease cost $ 39 $ 37

v3.25.1

Stock-based compensation (Details) - shares
1 Months Ended

Jan. 01, 2025

Jan. 01, 2024

Jul. 13, 2023

Feb. 28, 2025

Mar. 31, 2025

Mar. 31, 2024

2023 Equity incentive plan

Stock-based compensation

Common stock reserved for future issuance (in shares) 2,585,968 4,667,978

Annual increase in reserved shares (as a percent) 4.00%

Increase in future issuance (in shares) 1,226,994 855,016

Available for grant (in shares) 1,670,598

Contractual term 10 years

2024 Inducement Grants

Stock-based compensation

Common stock reserved for future issuance (in shares) 1,300,000 1,000,000

Increase in future issuance (in shares) 300,000

Available for grant (in shares) 404,017

Employee Stock Purchase Plan

Stock-based compensation

Common stock reserved for future issuance (in shares) 215,497 644,748

Annual increase in reserved shares (as a percent) 1.00%

Increase in future issuance (in shares) 215,497 213,754

Employee Stock Purchase Plan | Series A Common Stock

Stock-based compensation

Common stock reserved for future issuance (in shares) 215,497

v3.25.1

Stock-based compensation - Stock options (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 12 Months Ended

Mar. 31, 2025

Mar. 31, 2024

Dec. 31, 2024

Number of Shares

Balance at the beginning 4,462,517

Options granted 1,032,289

Options forfeited/expired (147)

Balance at the end 5,494,659 4,462,517

Vested and expected to vest 5,494,659

Exercisable at the end 2,741,368

Weighted-Average Exercise Price

Balance at the beginning (in dollars per share) $ 6.58

Options granted (in dollars per share) 4.71

Options forfeited/expired (in dollars per share) 23.05

Balance at the end (in dollars per share) 6.23 $ 6.58

Vested and expected to vest (in dollars per share) 6.23

Exercisable at the end (in dollars per share) $ 7.06

Term and Intrinsic Value

Weighted- Average Remaining Contractual Term, Outstanding 7 years 8 months 12 days 7 years 4 months 24 days

Weighted Average Remaining Contractual Term - Vested and expected to vest 7 years 8 months 12 days

Weighted- Average Remaining Contractual Term, Exercisable 6 years 2 months 12 days

Aggregate Intrinsic Value, Outstanding $ 26 $ 619

Aggregate Intrinsic Value - Vested and expected to vest $ 26

Weighted average grant date fair value $ 3.71 $ 4.34

Intrinsic value options exercised $ 100

Proceeds from exercise of stock options $ 114

Time-based options

Term and Intrinsic Value

Vesting period 4 years

Total unrecognized compensation cost $ 11,100

Unrecognized compensation cost remaining period 2 years 8 months 12 days

Performance-based options

Number of Shares

Balance at the end 492,729

Weighted-Average Exercise Price

Balance at the end (in dollars per share) $ 6.42

v3.25.1

Stock-based compensation - Restricted Stock Units (Details)
$ / shares in Units, $ in Millions
3 Months Ended

Mar. 31, 2025

USD ($)

$ / shares

shares

Restricted Stock Units

Stock-based compensation

Balance at the beginning (in shares) 844,382

Granted (in shares) 254,017

Balance at the end (in shares) 1,098,399

Weighted average grant date fair value, beginning (in dollars per shares) | $ / shares $ 2.96

Weighted average grant date fair value, granted (in dollars per shares) | $ / shares 4.71

Weighted average grant date fair value, ending (in dollars per shares) | $ / shares $ 3.36

Unrecognized compensation expense | $ $ 3.1

Unrecognized compensation cost remaining period 2 years 10 months 24 days

Employee Stock Purchase Plan

Stock-based compensation

Granted (in shares) 0

v3.25.1

Stock-based compensation - Fair value input (Details) - Employee Stock Option
3 Months Ended

Mar. 31, 2025

Mar. 31, 2024

Stock-based compensation

Expected volatility 95.00% 96.00%

Risk-free interest rate 4.30% 4.10%

Dividend yield 0.00% 0.00%

Expected term 6 years 6 years 1 month 6 days

v3.25.1

Related Party Transactions (Details) - USD ($)
$ in Thousands
3 Months Ended

Mar. 31, 2025

Mar. 31, 2024

Related parties

Research and development expenses $ 15,342 $ 5,262

Related party | Ascletis

Related parties

Research and development expenses $ 96

v3.25.1

Segment Reporting (Details)
$ in Thousands
3 Months Ended

Mar. 31, 2025

USD ($)

segment

Mar. 31, 2024

USD ($)

Segment Reporting

Number of operating segments | segment 1

Number of reportable segments | segment 1

External research and development expenses $ 15,342 $ 5,262

External General and administrative expenses 4,523 3,506

Stock-based compensation expense 1,472 759

Net loss (18,176) (6,629)

Operating segment

Segment Reporting

External research and development expenses 14,170 4,191

External General and administrative expenses 2,252 2,097

Personnel costs 1,951 1,478

Stock-based compensation expense 1,472 759

Other segment items $ (1,669) (1,896)

Other income - Description Other segment items consist of (i) interest and other income, net and (ii) other internal operating research and development expenses

Net loss $ (18,176) $ (6,629)

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   "role": "http://www.xbrl.org/2009/role/commonPracticeRef",
   "Topic": "946",
   "SubTopic": "220",
   "Name": "Accounting Standards Codification",
   "Section": "S99",
   "Paragraph": "3",
   "Subparagraph": "(SX 210.6-09(7))",
   "Publisher": "FASB",
   "URI": "https://asc.fasb.org/1943274/2147479134/946-220-S99-3"
  }
 }
}

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2025	May 02, 2025
Document information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2025
Document Transition Report	false
Securities Act File Number	001-41742
Entity Registrant Name	Sagimet Biosciences Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	20-5991472
Entity Address, Address Line One	155 Bovet Road, 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
Title of 12(b) Security	Series A Common Stock,$0.0001 par value per share
Trading Symbol	SGMT
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Central Index Key	0001400118
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2025
Document Fiscal Period Focus	Q1
Amendment Flag	false
Series A Common Stock
Document information
Entity Common Stock, Shares Outstanding		30,674,855
Series B Common Stock
Document information
Entity Common Stock, Shares Outstanding		1,520,490

CONDENSED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Current assets:
Cash and cash equivalents	$ 64,717	$ 75,840
Short-term marketable securities	79,852	75,410
Prepaid expenses and other current assets	1,503	1,524
Total current assets	146,072	152,774
Long-term marketable securities		7,408
Operating lease right-of-use assets	38	77
Other long-term assets	62
Total assets	146,172	160,259
Current liabilities:
Accounts payable	3,223	1,425
Accrued expenses and other current liabilities	3,918	2,951
Operating lease liabilities	39	78
Total liabilities	7,180	4,454
Commitments and contingencies (Note 6)
Stockholders' equity:
Undesignated preferred stock, $0.0001 per share: 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2025 and December 31, 2024
Additional paid-in capital	452,355	450,883
Accumulated deficit	(313,487)	(295,311)
Accumulated other comprehensive income	121	230
Total stockholders' equity	138,992	155,805
Total liabilities and stockholders' equity	146,172	160,259
Series A Common Stock
Stockholders' equity:
Common stock	3	3
Series B Common Stock
Stockholders' equity:
Common stock

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2025	Dec. 31, 2024
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Series A Common Stock
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	500,000,000	500,000,000
Common stock, shares issued	30,674,855	30,674,855
Common stock, shares outstanding	30,674,855	30,674,855
Series B Common Stock
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	15,000,000	15,000,000
Common stock, shares issued	1,520,490	1,520,490
Common stock, shares outstanding	1,520,490	1,520,490

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Operating expenses:
Research and development expenses	$ 15,342	$ 5,262
General and administrative expenses	4,523	3,506
Total operating expenses	19,865	8,768
Loss from operations	(19,865)	(8,768)
Other income :
Interest income and other, net	1,689	2,139
Total other income	1,689	2,139
Net loss	$ (18,176)	$ (6,629)
Net loss per share, basic (in dollars per share)	$ (0.56)	$ (0.23)
Net loss per share, diluted (in dollars per share)	$ (0.56)	$ (0.23)
Weighted-average shares outstanding, basic (in shares)	32,195,345	29,039,427
Weighted-average shares outstanding, diluted (in shares)	32,195,345	29,039,427
Other comprehensive income:
Net loss	$ (18,176)	$ (6,629)
Net unrealized loss on marketable securities	(109)	(23)
Total comprehensive loss	$ (18,285)	$ (6,652)

CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Common stock Series A Common Stock	Common stock Series B Common Stock	Additional paid-in capital	Accumulated deficit	Accumulated Other Comprehensive (Loss) Income	Series A Common Stock	Series B Common Stock	Total
Beginning balance at Dec. 31, 2023	$ 2,000		$ 340,777,000	$ (249,744,000)	$ 30,000			$ 91,065,000
Beginning balance (in shares) at Dec. 31, 2023	21,375,402	1,520,490
Increase (Decrease) In Stockholders' Deficit
Sale of Series A common stock, net of issuance costs	$ 1,000		104,731,000					104,732,000
Sale of Series A common stock, net of issuance costs (in shares)	9,000,000
Issuance of Series A Common Stock upon exercise of stock options			114,000					114,000
Issuance of Series A Common Stock upon exercise of stock options (in shares)	17,995
Stock-based compensation expense			759,000					759,000
Unrealized loss on marketable securities					(23,000)			(23,000)
Net loss	$ 0	$ 0	0	(6,629,000)	0			(6,629,000)
Ending balance at Mar. 31, 2024	$ 3,000		446,381,000	(256,373,000)	7,000			190,018,000
Ending balance (in shares) at Mar. 31, 2024	30,393,397	1,520,490
Beginning balance at Dec. 31, 2024	$ 3,000		450,883,000	(295,311,000)	230,000			155,805,000
Beginning balance (in shares) at Dec. 31, 2024	30,674,855	1,520,490				30,674,855	1,520,490
Increase (Decrease) In Stockholders' Deficit
Stock-based compensation expense			1,472,000					1,472,000
Unrealized loss on marketable securities					(109,000)			(109,000)
Net loss	$ 0	$ 0	0	(18,176,000)	0			(18,176,000)
Ending balance at Mar. 31, 2025	$ 3,000		$ 452,355,000	$ (313,487,000)	$ 121,000			$ 138,992,000
Ending balance (in shares) at Mar. 31, 2025	30,674,855	1,520,490				30,674,855	1,520,490

CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - Parenthetical $ in Thousands	3 Months Ended
	Mar. 31, 2024 USD ($)
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY
Issuance costs	$ 7,796

CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended		12 Months Ended
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	Mar. 31, 2025	Mar. 31, 2024	Dec. 31, 2024	Dec. 31, 2023
Cash flows from operating activities
Net loss	$ (18,176)	$ (6,629)
Adjustments to reconcile net loss to net cash used in operating activities:
Accretion of discount on marketable securities	(535)	(193)
Non-cash operating lease expense	39	36
Stock-based compensation expense	1,472	759
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(687)	640
Accounts payable, accrued expenses and other current liabilities	3,390	(782)
Operating lease liabilities	(39)	(39)
Net cash used in operating activities	(14,536)	(6,208)
Cash flows from investing activities
Purchases of marketable securities	(15,575)
Sales and maturities of marketable securities	18,988	3,000
Net cash provided by investing activities	3,413	3,000
Cash flows from financing activities
Proceeds from sale of Series A common stock, net of issuance costs		105,750
Payment of financing costs		(1,018)
Proceeds from exercise of stock options		114
Net cash provided by financing activities		104,846
Net (decrease) increase in cash and cash equivalents			$ (11,123)	$ 101,638
Cash and cash equivalents at beginning of period	75,840	75,139	75,139
Cash and cash equivalents at end of period	64,717	$ 176,777	$ 75,840	$ 75,139
Supplemental non-cash investing and financing activities:
Deferred financing costs within accounts payable and accrued expenses	$ 245

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Mar. 31, 2025	Mar. 31, 2024
Pay vs Performance Disclosure
Net Income (Loss)	$ (18,176)	$ (6,629)

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Mar. 31, 2025
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Description of Business and Basis of Presentation (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended		2 Months Ended	3 Months Ended
	Aug. 31, 2024	Jan. 31, 2024	Aug. 31, 2023	Mar. 31, 2025	Mar. 31, 2024	Dec. 31, 2024
Organization and description of business
Accumulated deficit				$ 313,487		$ 295,311
Cash and cash equivalents and marketable securities				144,600
Issuance costs					$ 7,796
Series A Common Stock
Organization and description of business
Shares issued (in shares)		9,000,000	6,026,772
Share price (in dollars per share)		$ 12.5	$ 16
Net proceeds		$ 104,700	$ 86,200
Issuance costs		$ 7,800
At market arrangement
Organization and description of business
Net proceeds				$ 0
Maximum value of sales under the arrangement	$ 75,000

Summary of significant accounting policies - EPS (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Numerator:
Net loss	$ (18,176)	$ (6,629)
Denominator:
Weighted-average shares outstanding, basic (in shares)	32,195,345	29,039,427
Weighted-average shares outstanding, diluted (in shares)	32,195,345	29,039,427
Net loss per share, basic (in dollars per share)	$ (0.56)	$ (0.23)
Net loss per share, diluted (in dollars per share)	$ (0.56)	$ (0.23)

Summary of significant accounting policies - Dilutive (Details) - shares	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Antidilutive securities
Potentially dilutive securities (in shares)	6,594,058	4,645,643
Stock options
Antidilutive securities
Potentially dilutive securities (in shares)	5,494,659	3,518,803
Warrants
Antidilutive securities
Potentially dilutive securities (in shares)	1,000	1,000
Restricted stock units
Antidilutive securities
Potentially dilutive securities (in shares)	1,098,399	1,125,840

Fair value measurements and fair value of financial instruments - Warrants (Details) - Series A common stock warrant	Mar. 31, 2025 $ / shares shares
Redeemable Convertible Preferred Stock Warrant Liability
Warrants issued (in shares) \| shares	1,000
Exercise price of warrant (in dollars per share) \| $ / shares	$ 69.94

Fair value measurements and fair value of financial instruments - Fair value (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Fair value on a recurring basis
Cash equivalents fair value	$ 64,200	$ 75,300
Unrealized Gains	125	233
Unrealized Losses	(4)	(3)
Level 2
Fair value on a recurring basis
Marketable securities	$ 79,900	82,800
Level 2 \| Minimum
Fair value on a recurring basis
Expected maturity term	0 months
Level 2 \| Maximum
Fair value on a recurring basis
Expected maturity term	10 months 21 days
Amortized cost
Fair value on a recurring basis
Cash equivalents fair value	$ 64,201	75,277
Total assets fair value	143,932	157,865
Amortized cost \| Level 1 \| Money market funds
Fair value on a recurring basis
Cash equivalents fair value	64,201	72,800
Amortized cost \| Level 2 \| U.S. Treasury securities
Fair value on a recurring basis
Cash equivalents fair value		2,477
Short-term
Fair value on a recurring basis
Unrealized Gains	125	189
Unrealized Losses	(4)	(3)
Short-term \| Level 2 \| Commercial paper
Fair value on a recurring basis
Unrealized Gains	4	25
Unrealized Losses	(2)	(1)
Short-term \| Level 2 \| Corporate debt securities
Fair value on a recurring basis
Unrealized Gains	2	7
Short-term \| Level 2 \| U.S. Treasury securities
Fair value on a recurring basis
Unrealized Gains	109	123
Short-term \| Level 2 \| Agency securities
Fair value on a recurring basis
Unrealized Gains		12
Unrealized Losses	(2)	(2)
Short-term \| Level 2 \| Asset-backed securities
Fair value on a recurring basis
Unrealized Gains	10	22
Short-term \| Amortized cost
Fair value on a recurring basis
Marketable securities	79,731	75,224
Short-term \| Amortized cost \| Level 2 \| Commercial paper
Fair value on a recurring basis
Marketable securities	20,988	14,447
Short-term \| Amortized cost \| Level 2 \| Corporate debt securities
Fair value on a recurring basis
Marketable securities	4,465	6,909
Short-term \| Amortized cost \| Level 2 \| U.S. Treasury securities
Fair value on a recurring basis
Marketable securities	39,924	27,493
Short-term \| Amortized cost \| Level 2 \| Agency securities
Fair value on a recurring basis
Marketable securities	11,868	21,345
Short-term \| Amortized cost \| Level 2 \| Asset-backed securities
Fair value on a recurring basis
Marketable securities	2,486	5,030
Long-term
Fair value on a recurring basis
Unrealized Gains		44
Long-term \| Level 2 \| U.S. Treasury securities
Fair value on a recurring basis
Unrealized Gains		36
Long-term \| Level 2 \| Asset-backed securities
Fair value on a recurring basis
Unrealized Gains		8
Long-term \| Amortized cost
Fair value on a recurring basis
Marketable securities		7,364
Long-term \| Amortized cost \| Level 2 \| U.S. Treasury securities
Fair value on a recurring basis
Marketable securities		4,884
Long-term \| Amortized cost \| Level 2 \| Asset-backed securities
Fair value on a recurring basis
Marketable securities		2,480
Recurring \| Estimated Fair Value
Fair value on a recurring basis
Cash equivalents fair value	64,201	75,277
Total assets fair value	144,053	158,095
Recurring \| Estimated Fair Value \| Level 1 \| Money market funds
Fair value on a recurring basis
Cash equivalents fair value	64,201	72,800
Recurring \| Estimated Fair Value \| Level 2 \| U.S. Treasury securities
Fair value on a recurring basis
Cash equivalents fair value		2,477
Recurring \| Short-term \| Estimated Fair Value
Fair value on a recurring basis
Marketable securities	79,852	75,410
Recurring \| Short-term \| Estimated Fair Value \| Level 2 \| Commercial paper
Fair value on a recurring basis
Marketable securities	20,990	14,471
Recurring \| Short-term \| Estimated Fair Value \| Level 2 \| Corporate debt securities
Fair value on a recurring basis
Marketable securities	4,467	6,916
Recurring \| Short-term \| Estimated Fair Value \| Level 2 \| U.S. Treasury securities
Fair value on a recurring basis
Marketable securities	40,033	27,616
Recurring \| Short-term \| Estimated Fair Value \| Level 2 \| Agency securities
Fair value on a recurring basis
Marketable securities	11,866	21,355
Recurring \| Short-term \| Estimated Fair Value \| Level 2 \| Asset-backed securities
Fair value on a recurring basis
Marketable securities	$ 2,496	5,052
Recurring \| Long-term \| Estimated Fair Value
Fair value on a recurring basis
Marketable securities		7,408
Recurring \| Long-term \| Estimated Fair Value \| Level 2 \| U.S. Treasury securities
Fair value on a recurring basis
Marketable securities		4,920
Recurring \| Long-term \| Estimated Fair Value \| Level 2 \| Asset-backed securities
Fair value on a recurring basis
Marketable securities		$ 2,488

Prepaid expenses and other current assets (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Prepaid expenses and other current assets
Prepaid clinical expenses	$ 226	$ 436
Prepaid research and development	112	48
Prepaid insurance	277	577
Deferred financing costs	625	306
Other	263	157
Total prepaid expenses and other current assets	$ 1,503	$ 1,524

Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Accrued expenses and other current liabilities
Accrued payroll-related costs	$ 423	$ 1,358
Accrued clinical costs	665	528
Accrued research and development costs	1,829	516
Accrued general and administrative costs	938	544
Accrued offering costs	47
Other	16	5
Total accrued expenses and other current liabilities	$ 3,918	$ 2,951

Commitments and contingencies - Licenses (Details) $ in Millions	3 Months Ended
	Mar. 31, 2025 USD ($)
Commitments and contingencies.
Maximum eligible development and commercial milestone payments	$ 122.0

Commitments and contingencies - Lease (Details) $ in Thousands		1 Months Ended	3 Months Ended
	Mar. 12, 2019 USD ($) ft²	Apr. 30, 2024 USD ($)	Mar. 31, 2025 USD ($)	Mar. 31, 2024 USD ($)
Commitments and contingencies.
Operating lease term	38 months
Rented area (in square feet) \| ft²	3,030
Monthly lease payments	$ 12	$ 13
Change in operating lease liability		$ 100
Operating lease cost			$ 39	$ 37

Stock-based compensation (Details) - shares				1 Months Ended
Stock-based compensation (Details) - shares	Jan. 01, 2025	Jan. 01, 2024	Jul. 13, 2023	Feb. 28, 2025	Mar. 31, 2025	Mar. 31, 2024
2023 Equity incentive plan
Stock-based compensation
Common stock reserved for future issuance (in shares)			2,585,968		4,667,978
Annual increase in reserved shares (as a percent)			4.00%
Increase in future issuance (in shares)	1,226,994	855,016
Available for grant (in shares)					1,670,598
Contractual term			10 years
2024 Inducement Grants
Stock-based compensation
Common stock reserved for future issuance (in shares)					1,300,000	1,000,000
Increase in future issuance (in shares)				300,000
Available for grant (in shares)					404,017
Employee Stock Purchase Plan
Stock-based compensation
Common stock reserved for future issuance (in shares)			215,497		644,748
Annual increase in reserved shares (as a percent)			1.00%
Increase in future issuance (in shares)	215,497	213,754
Employee Stock Purchase Plan \| Series A Common Stock
Stock-based compensation
Common stock reserved for future issuance (in shares)			215,497

Stock-based compensation - Restricted Stock Units (Details) $ / shares in Units, $ in Millions	3 Months Ended
	Mar. 31, 2025 USD ($) $ / shares shares
Restricted Stock Units
Stock-based compensation
Balance at the beginning (in shares)	844,382
Granted (in shares)	254,017
Balance at the end (in shares)	1,098,399
Weighted average grant date fair value, beginning (in dollars per shares) \| $ / shares	$ 2.96
Weighted average grant date fair value, granted (in dollars per shares) \| $ / shares	4.71
Weighted average grant date fair value, ending (in dollars per shares) \| $ / shares	$ 3.36
Unrecognized compensation expense \| $	$ 3.1
Unrecognized compensation cost remaining period	2 years 10 months 24 days
Employee Stock Purchase Plan
Stock-based compensation
Granted (in shares)	0

Related Party Transactions (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Related parties
Research and development expenses	$ 15,342	$ 5,262
Related party \| Ascletis
Related parties
Research and development expenses		$ 96

Segment Reporting (Details) $ in Thousands	3 Months Ended
Segment Reporting (Details) $ in Thousands	Mar. 31, 2025 USD ($) segment	Mar. 31, 2024 USD ($)
Segment Reporting
Number of operating segments \| segment	1
Number of reportable segments \| segment	1
External research and development expenses	$ 15,342	$ 5,262
External General and administrative expenses	4,523	3,506
Stock-based compensation expense	1,472	759
Net loss	(18,176)	(6,629)
Operating segment
Segment Reporting
External research and development expenses	14,170	4,191
External General and administrative expenses	2,252	2,097
Personnel costs	1,951	1,478
Stock-based compensation expense	1,472	759
Other segment items	$ (1,669)	(1,896)
Other income - Description	Other segment items consist of (i) interest and other income, net and (ii) other internal operating research and development expenses
Net loss	$ (18,176)	$ (6,629)