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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, 2026


☐	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: 001-42490

MAZE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)


Delaware		82-2635018
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

171 Oyster Point Blvd., Suite 300

South San Francisco, California 94080

(Address of principal executive offices, including zip code)

(650) 850-5070

(Registrant's telephone number, including area code)

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


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock - par value $0.001 per share	MAZE	The Nasdaq Stock Market LLC

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 Act). YES ☐ NO ☒

As of May 7, 2026, the registrant had 55,345,261 shares of common stock outstanding.

TABLE OF CONTENTS


		Page Numbers

PART I	FINANCIAL INFORMATION	1
Item 1.	Financial Statements (Unaudited)	1
	Condensed Balance Sheets	1
	Condensed Statements of Operations and Comprehensive Loss	2
	Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)	3
	Condensed Statements of Cash Flows	4
	Notes to Condensed Financial Statements	5
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	26

PART II	OTHER INFORMATION	27
Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities	78
Item 3.	Defaults Upon Senior Securities	78
Item 4.	Mine Safety Disclosures	78
Item 5.	Other Information	78
Item 6.	Exhibits	79
SIGNATURES		80

Special note regarding forward-looking statements

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and the Private Securities Litigation Reform Act of 1995. These statements appear throughout this Quarterly Report on Form 10-Q and are statements regarding our intent, belief, or current expectations, primarily with respect to our business and related industry developments. In some cases, you can identify forward-looking statements by terms such as “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and similar expressions that convey uncertainty of future events or outcomes, although not all forward-looking statements contain these words. These statements appear throughout this Quarterly Report on Form 10-Q and are statements regarding our intent, belief, or current expectations, primarily with respect to our business and related industry developments. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Moreover, we operate in a competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report on Form 10-Q may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:

•

the timing of our preclinical studies and clinical trials for our therapeutic candidates, including statements regarding the anticipated timing of initiation and completion of studies or trials, the period during which the results of the trials will become available and our development plans;

•

the characteristics, safety, tolerability and efficacy of MZE829, MZE782 or any other therapeutic candidates we may develop;

•

our ability to develop, obtain and maintain regulatory approval for our therapeutic candidates or any other therapeutic candidates we may develop, including the timing of and costs involved;

•

estimates of our addressable market and market growth, including our estimates regarding the patient populations and market opportunities for our therapeutic candidates;

•

our expectations regarding demand for, and market acceptance of, our therapeutic candidates in any of the indications in which we plan to develop them, and any other therapeutic candidates we may develop;

•

our ability to use our Compass platform to identify new therapeutic targets and advance such targets into clinical development and validate such targets across multiple indications;

•

our ability to maintain and expand access to human genetics data;

•

our ability to compete effectively with existing competitors and new market entrants;

•

the potential effects of extensive government regulations in the United States and foreign countries relating to our industry;

•

our ability to obtain, maintain, protect and enforce intellectual property and proprietary rights;

•

our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights and proprietary technology of third parties;

•

our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements, including our ability to comply with our financial obligations pursuant to the terms of such agreements;

•

the timing and likelihood of the achievement of milestones pursuant to our existing collaboration and licensing agreements;

•

our reliance on and performance of third parties, including our clinical research organizations, or CROs, contract manufacturing organizations, or CMOs, suppliers and manufacturers;

•

our ability to expand our pipeline of therapeutic candidates;

•

our ability to attract and retain key management and technical personnel;

•

general economic, industry and market conditions, including fluctuating interest, inflation and tariff rates, uncertainty with respect to the federal debt ceiling and budget and the related potential for government shutdowns, uncertainty with respect to healthcare policies and regulation, instability in the global banking system, volatile market conditions, supply chain delays, and the ongoing labor shortage;

•

the impact of natural disasters, terrorist activity, pandemics, regional conflicts around the world and the global responses thereto and other events beyond our control on any of the above or any other aspect of our business operations;

•

our expectations regarding the period during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act; and

•

our expectations regarding expenses, future revenue, capital requirements, and our needs for additional financing.

The forward-looking statements made in this Quarterly Report on Form 10-Q relate only to events or information as of the date on which the statements are made in this Quarterly Report on Form 10-Q. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or to changes in our expectations, except as required by law.

You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed with the Securities and Exchange Commission, or SEC, as exhibits to this Quarterly Report on Form 10-Q with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.

iii

Summary of Risk Factors

Below is a summary of material factors that make an investment in our common stock speculative or risky. Importantly, this summary does not address all of the risks and uncertainties that we face. You should understand that it is not possible to predict or identify all such factors. Consequently, you should not consider this summary to be a complete discussion of all potential risks or uncertainties that may substantially impact our business. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, are described under the heading “Risk Factors” in this Quarterly Report on Form 10-Q, and this summary is qualified in its entirety by that discussion. Moreover, we operate in a competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible to predict the impact of all of these factors on our business, financial condition or results of operations. You should consider carefully the risks and uncertainties described below and under the heading “Risk Factors” in this Quarterly Report on Form 10-Q.

Some of the principal risks we are exposed to include:

•

We are a clinical-stage biopharmaceutical company with a limited operating history, which may make it difficult to evaluate the success of our business to date and to assess our future viability. Since our inception, we have incurred significant operating losses and have not generated any product revenue. We expect to incur continued losses for the foreseeable future and may never achieve or maintain profitability.

•

We will require substantial additional capital to finance our operations and achieve our goals. If we are unable to raise capital when needed or on terms acceptable to us, we may be forced to delay, reduce or eliminate our research or product development programs, any future commercialization efforts or other operations.

•

We are early in our development efforts and highly dependent on the success of our lead programs. If we are unable to commercialize our therapeutic candidates or experience significant delays in doing so, our business will be materially harmed.

•

Preclinical and clinical drug development is a lengthy and expensive process, with uncertain timelines and outcomes. If preclinical studies or clinical trials of our therapeutic candidates are prolonged or delayed, we may be unable to obtain required regulatory approvals, and therefore be unable to commercialize our therapeutic candidates or any of our future therapeutic candidates on a timely basis or at all.

•

We may not be successful in applying our Compass platform to identify targets with therapeutic potential or to discover and develop safe, effective or commercially viable therapeutic candidates.

•

Certain of the diseases we, or which our partners, seek to treat have low prevalence and/or have available therapies, and it may be difficult for us or our partners to identify patients with these diseases or face competition in the recruitment of these limited groups of patients, which may lead to difficulties in enrolling clinical trials.

•

Our Compass platform relies on access to high quality data repositories with paired genetic and clinical data and loss of such access, or the inability to use such data, could have a material adverse effect on our business, financial condition, results of operations and prospects.

•

We have entered, and may in the future enter, into strategic collaborations, transactions and licensing partnerships for research, development or commercialization of our programs, including our first therapeutic candidate MZE001, and we may not be able to realize the full value of these partnerships or our partnered programs.

•

We face significant competition in an environment of rapid technological change and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies or technologies that are more advanced or effective than ours, which may harm our business and financial condition, and our ability to successfully market or commercialize our therapeutic candidates.

•

Our success depends in part on our and our partners’ ability to obtain, maintain, enforce and protect our intellectual property and proprietary rights. It is difficult and costly to protect our intellectual property rights and technologies, and we may not be able to ensure their protection. If we are unable to adequately protect our technologies or obtain and maintain patent protection for our technologies and products or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technologies and products similar or identical to ours, and our ability to successfully commercialize our technologies and products may be impaired.

•

If we are sued for infringing, misappropriating or otherwise violating intellectual property or proprietary rights of third parties, such litigation or disputes could be costly and time-consuming and could prevent or delay us from developing or commercializing our therapeutic candidates.

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

Maze Therapeutics, Inc.

Condensed Balance Sheets

(unaudited)

(in thousands, except share and per share data)


	March 31,			December 31,
	2026			2025
Assets
Current assets:
Cash and cash equivalents	$	198,766		$	189,247
Marketable securities, current		153,616			152,670
Accounts receivable		20,000			—
Prepaid expenses and other current assets		7,397			7,800
Total current assets		379,779			349,717
Property and equipment, net		4,682			5,044
Restricted cash		1,088			1,088
Marketable securities, non-current		10,556			18,114
Operating lease right-of-use asset		19,285			20,116
Other assets		4,320			3,048
Total assets	$	419,710		$	397,127
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	4,013		$	1,794
Accrued expenses and other current liabilities		12,385			15,967
Operating lease liabilities, current		4,838			4,795
Total current liabilities		21,236			22,556
Operating lease liabilities, net of current portion		17,552			18,511
Term loan, non-current		38,833			—
Other liabilities, non-current		388			1,094
Total liabilities		78,009			42,161
Commitments and contingencies (Note 9)
Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of March 31, 2026 and December 31, 2025; no shares issued and outstanding as of March 31, 2026 and December 31, 2025		—			—
Common stock, $0.001 par value; 500,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 49,737,619 and 49,335,551 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively; 10,372 shares subject to repurchase as of March 31, 2026 and December 31, 2025		50			49
Additional paid-in-capital		855,541			844,354
Accumulated other comprehensive (loss) income		(135	)		110
Accumulated deficit		(513,755	)		(489,547	)
Total stockholders’ equity		341,701			354,966
Total liabilities and stockholders’ equity	$	419,710		$	397,127

See accompanying notes to these financial statements.

Maze Therapeutics, Inc.

Condensed Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except share and per share data)


	Three Months Ended March 31,
	2026			2025
License revenue	$	20,000		$	—
Operating expenses:
Research and development		34,148			27,580
General and administrative		12,405			7,821
Total operating expenses		46,553			35,401
Loss from operations		(26,553	)		(35,401	)
Other income (expense):
Interest and other income, net		3,211			2,615
Interest expense		(866	)		—
Total other income, net		2,345			2,615
Net loss	$	(24,208	)	$	(32,786	)
Net loss per share, basic and diluted (see Note 12):	$	(0.45	)	$	(1.15	)
Weighted-average shares of common stock outstanding used to compute net loss per share, basic and diluted (see Note 12):		53,897,216			28,628,430
Comprehensive loss:
Net loss	$	(24,208	)	$	(32,786	)
Other comprehensive loss:
Net unrealized loss on marketable securities		(245	)		—
Comprehensive loss	$	(24,453	)	$	(32,786	)

See accompanying notes to these financial statements.

Maze Therapeutics, Inc.

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(unaudited)

(in thousands, except share data)


	Redeemable convertible										Additional		Accumulated						Total
	preferred stock						Common stock				paid-in		other comprehensive			Accumulated			stockholders’
	Shares			Amount			Shares		Amount		capital		income (loss)			deficit			equity (deficit)
Balance as of December 31, 2024		297,205,041		$	508,087			2,446,864	$	2	$	47,242	$	—		$	(358,427	)	$	(311,183	)
Issuance of common stock in connection with initial public offering, net of issuance costs of $15,402		—			—			8,750,000		9		124,589		—			—			124,598
Conversion of redeemable convertible preferred stock to common stock upon initial public offering		(297,205,041	)		(508,087	)		32,586,823		33		508,054		—			—			508,087
Exercise of stock options		—			—			13,479		—		126		—			—			126
Stock-based compensation expense		—			—			—		—		3,226		—			—			3,226
Net loss		—			—			—		—		—		—			(32,786	)		(32,786	)
Balance as of March 31, 2025		—		$	—			43,797,166	$	44	$	683,237	$	—		$	(391,213	)	$	292,068

	Redeemable convertible										Additional		Accumulated						Total
	preferred stock						Common stock				paid-in		other comprehensive			Accumulated			stockholders’
	Shares			Amount			Shares		Amount		capital		income (loss)			deficit			equity
Balance as of December 31, 2025		—		$	—			49,335,551	$	49	$	844,354	$	110		$	(489,547	)	$	354,966
Exercise of stock options		—			—			402,067		1		4,078		—			—			4,079
Issuance of common stock upon vesting of restricted stock awards		—			—			1		—		—		—			—			—
Stock-based compensation expense		—			—			—		—		7,109		—			—			7,109
Net unrealized loss on marketable securities		—			—			—		—		—		(245	)		—			(245	)
Net loss		—			—			—		—		—		—			(24,208	)		(24,208	)
Balance as of March 31, 2026		—		$	—			49,737,619	$	50	$	855,541	$	(135	)	$	(513,755	)	$	341,701

See accompanying notes to these financial statements.

Maze Therapeutics, Inc.

Condensed Statements of Cash Flows

(unaudited)

(in thousands)


	Three Months Ended March 31,
	2026			2025
Operating activities
Net loss	$	(24,208	)	$	(32,786	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		444			684
Stock-based compensation expense		7,109			3,226
Non-cash lease expense		831			767
Accretion of discounts on marketable securities, net		(2	)		—
Amortization of debt discount and debt issuance costs		371			—
Other items, net		18			18
Changes in operating assets and liabilities:
Accounts receivable		(20,000	)		—
Prepaid expenses and other current assets		404			(474	)
Other assets		(605	)		338
Accounts payable		2,212			579
Accrued expenses and other liabilities		(4,066	)		(1,063	)
Operating lease liabilities		(915	)		(805	)
Long-term liabilities		(706	)		—
Net cash used in operating activities		(39,113	)		(29,516	)
Investing activities
Purchases of marketable securities		(23,632	)		—
Maturities of marketable securities		30,000			—
Purchases of property and equipment		(93	)		(299	)
Net cash provided by (used) in investing activities		6,275			(299	)
Financing activities
Proceeds from debt issuance, net		39,401			—
Payment of debt issuance costs		(886	)		—
Proceeds from exercise of stock option awards		4,079			126
Payment of deferred offering costs		(226	)		—
Payment of offering costs for private placement		(11	)		—
Proceeds from initial public offering, net of offering costs paid		—			127,752
Payment of success fee derivative		—			(500	)
Net cash provided by financing activities		42,357			127,378
Net increase in cash, cash equivalents and restricted cash		9,519			97,563
Cash, cash equivalents and restricted cash at beginning of the period		190,335			197,900
Cash, cash equivalents and restricted cash at end of the period	$	199,854		$	295,463
Supplemental disclosure of non-cash investing and financing activities
Purchases of property and equipment recorded in accounts payable and accrued expenses	$	6		$	48
Debt issuance costs recorded in accounts payable and accrued expenses	$	53		$	—
Deferred offering costs recorded in accrued expenses	$	441		$	—
Reconciliation to cash, cash equivalents and restricted cash:
Cash and cash equivalents	$	198,766		$	294,374
Restricted cash		1,088			1,089
Total cash, cash equivalents and restricted cash	$	199,854		$	295,463

See accompanying notes to these financial statements.

Maze Therapeutics, Inc.

Notes to Condensed Financial Statements

(Unaudited)

Organization and principal activities

Description of business

Maze Therapeutics, Inc., or the Company, is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with kidney and metabolic diseases. The Company was incorporated in Delaware in August 2017 and is located in South San Francisco, California.

2026 Sale Agreement

In February 2026, the Company entered into an Open Market Sale Agreement with Jefferies LLC, serving as sales agent, with respect to an at-the-market offering program pursuant to which the Company may elect to issue and sell shares of its common stock having an aggregate offering price of up to $200.0 million, or the 2026 Sale Agreement, in such quantities and on such minimum price terms as the Company sets from time to time through the its sales agent. The Company has agreed to pay its sales agent an aggregate commission equal to up to 3.0% of the gross proceeds of the sales under the agreement. To date, no sales of common stock have occurred under the 2026 Sale Agreement.

Hercules Loan and Security Agreement

In February 2026, the Company entered into a loan and security agreement, or the Hercules Loan Agreement, with certain lenders and Hercules Capital, Inc., in its capacity as administrative agent and collateral agent for itself and the lenders, which provides for a senior secured term loan facility in an aggregate principal amount of up to $200.0 million, or the Hercules Term Loan Facility. An initial term loan of $40.0 million was funded under the Hercules Loan Agreement and the Hercules Term Loan Facility includes up to six additional term loan tranches providing up to an aggregate $160.0 million in additional loan commitments through February 2031, so long as the Company satisfies certain conditions precedent. The final tranche of $50.0 million is subject to approval by the lenders’ investment committee. The Hercules Loan Agreement has a maturity date of February 1, 2031, and may be prepaid at any time, subject to prepayment premiums. See Note 10, Loan and security agreements, for further discussion of the Hercules Loan Agreement.

Liquidity and capital resources

The Company has incurred significant losses and negative cash flows from operations and expects to incur significant and increasing losses as a result of its continued research and development activities. As of March 31, 2026, the Company had an accumulated deficit of $513.8 million. Historically, the Company has financed its operations primarily through issuances of its equity, issuances of convertible promissory notes, debt financings and license agreements. The Company may seek to raise capital through additional term loan tranches pursuant to the Hercules Term Loan Facility, equity financings, including pursuant to the 2026 Sale Agreement, license agreements, or other sources of financing. There can be no assurance that such financing will be available or will be at terms acceptable to the Company.

As of March 31, 2026, the Company had cash, cash equivalents and marketable securities of $362.9 million. In April 2026, the Company completed an underwritten registered offering of its common stock and pre-funded warrants to purchase common stock for estimated net proceeds of approximately $144.7 million and received a $20.0 million payment from Shionogi & Co., Ltd., or Shionogi, in connection with a clinical development milestone achieved in March 2026. The Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations for at least one year from the issuance date of these unaudited condensed financial statements. See Note 13, Subsequent events, for further discussion of the underwritten registered offering and Shionogi milestone payment.

Summary of significant accounting policies

Basis of presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, for interim financial information and the instructions to Form 10-Q and Article 10 of the Securities and Exchange Commission, or SEC, Regulation S-X for interim financial information.

These unaudited condensed financial statements and notes should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 25, 2026, or the 2025 10-K. The condensed balance sheet as of December 31, 2025 was derived from the audited annual financial statements as of and for the period then ended. Certain information and footnote disclosures included in the Company’s annual financial statements have been condensed or omitted. The accompanying unaudited condensed financial statements reflect all adjustments that, in the opinion of management, are necessary for a fair presentation of the Company’s financial position, results of operations and cash flows for the periods presented. All such adjustments are of a normal recurring nature except for the impacts of adopting new accounting standards, if any, discussed below. These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period.

There were no changes to the Company’s significant accounting policies during the three months ended March 31, 2026, as described in the Company’s audited financial statements as of and for the year ended December 31, 2025 included in the 2025 10-K.

Use of estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. The Company bases its estimates on historical experience and market-specific or other relevant assumptions that it believes are reasonable under the circumstances. Assets and liabilities reported in the Company’s condensed balance sheet and revenue and expenses reported in the Company's condensed statement of operations and comprehensive loss are affected by estimates and assumptions, which are used for, but are not limited to, measuring and recognizing revenue, including any related constraints, and determining the fair value of assets and liabilities, including income tax uncertainties, the measurement of stock-based compensation expense, and certain accruals. Actual results could differ from such estimates or assumptions.

Segment reporting

The Company operates and manages its business as one reportable and operating segment, which is the business of harnessing its understanding of human genetics and variant functionalization to develop small molecule precision medicines. The Company’s chief executive officer, who is the chief operating decision maker, or CODM, reviews financial information on an aggregate basis for allocating resources and evaluating financial performance.

The CODM, in alignment with the Company’s overall corporate strategy and goals, analyzes a variety of data to guide segment resource allocation, including program and portfolio scientific data, probability of regulatory and commercial success, and the competitive environment. The CODM also reviews certain financial results included in the segment loss from operations which is reported on the condensed statements of operations and comprehensive loss as total loss from operations. The measure of segment assets is reported on the condensed balance sheets as total assets.

As of March 31, 2026 and December 31, 2025, all of the Company’s property and equipment was maintained in the United States. The Company generated license revenue of $20.0 million during the three months ended March 31, 2026. No revenue was generated during the three months ended March 31, 2025. The following table presents selected financial information with respect to the Company’s single operating segment for the three months ended March 31, 2026 and 2025 (amounts in thousands):


	Three Months Ended March 31,
	2026			2025
License revenue	$	20,000		$	—
Research and development expenses
Personnel-related costs		13,991			10,344
Clinical trial expenses		7,576			5,676
Outside research and development services		5,829			4,921
Manufacturing expenses		1,792			1,187
Facilities, depreciation and other expenses		4,960			5,452
Total research and development expenses		34,148			27,580
General and administrative expenses		12,405			7,821
Segment operating expenses		46,553			35,401
Segment loss from operations		(26,553	)		(35,401	)
Segment other income, net		2,345			2,615
Segment loss	$	(24,208	)	$	(32,786	)

Fair value measurement

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, or an exit price, in the principal or most advantageous market for that asset or liability in an orderly transaction between market participants on the measurement date, and establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value.

The Company determined the fair value of financial assets and liabilities using the fair value hierarchy that describes three levels of inputs that may be used to measure fair value, as follows:

•

Level 1—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets;

•

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; and

•

Level 3—Unobservable inputs reflecting the Company’s own assumptions incorporated in valuation techniques used to determine fair value. These assumptions are required to be consistent with market participant assumptions that are reasonably available.

For certain financial instruments, including cash and accounts payable, as well as certain accrued liabilities, the recorded amount approximates estimated fair value due to their relatively short maturity period.

Cash, cash equivalents and restricted cash

The Company considers all highly liquid financial instruments with original maturities of 90 days or less at the date of purchase to be cash equivalents. As of March 31, 2026 and December 31, 2025, cash equivalents consisted of money market funds.

Restricted cash is comprised of cash that is restricted as to withdrawal or use under the terms of certain contractual agreements. Restricted cash as of March 31, 2026 and December 31, 2025 included $1.1 million as collateral for a letter of credit related to the Company’s headquarters building lease in South San Francisco, California. Restricted cash is classified as a noncurrent asset on the balance sheet. As of March 31, 2026 and December 31, 2025, restricted cash consisted of money market funds.

Deferred offering costs

The Company defers offering costs consisting of legal, accounting and other fees and costs directly associated with in-process equity financings until such financings are consummated. After consummation of the equity financing, these costs are classified in stockholders’ equity as a reduction of the additional paid-in capital recorded as a result of the financing. If the in-process financing is abandoned, the deferred offering costs are expensed immediately as a charge to operating expenses in the condensed statements of operations and comprehensive loss. As of March 31, 2026, approximately $0.7 million of deferred offering costs related to the Company’s underwritten registered offering completed in April 2026 were recorded within other assets in the accompanying condensed balance sheets.

Debt issuance costs and debt discount

Debt issuance costs include legal fees, accounting fees, and other direct costs incurred in connection with the execution of the Company's debt financing. Debt discount represents costs paid to the lenders. Debt issuance costs and debt discount are deducted from the carrying amount of the debt liability and are amortized to interest expense over the term of the related debt using the effective interest method.

Revenue recognition

The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers, or ASC 606. To determine the appropriate amount and timing of revenue to be recognized under this guidance, the Company performs the following steps: (i) identifies the contract(s) with a customer; (ii) identifies the performance obligations in the contract; (iii) determines the transaction price, including variable consideration, if any; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when (or as) the entity satisfies a performance obligation.

The Company has entered into arrangements involving the license of intellectual property. Analyzing the license arrangements to identify performance obligations requires the use of judgment. In arrangements that include the license of intellectual property and other promised services, the Company first identifies if the licenses are distinct from the other promises in the arrangement. For the license of intellectual property that is distinct, the Company recognizes revenue from consideration allocated to the license when the license is transferred and the customer is able to benefit from the license. If the license is not distinct, the license is combined with other services into a single performance obligation and the Company recognizes revenue when (or as) the performance obligation is satisfied. Factors that are considered in evaluating whether a license is distinct from other promised services include, for example, whether the counterparty can benefit from the license without the promised service on its own or with other readily available resources and whether the promised service is expected to significantly modify or customize the intellectual property. Promised goods and services that are not material in the context of the contract are not considered performance obligations.

The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Non-refundable upfront payments are considered fixed consideration and included in the transaction price. At the inception of an arrangement and at each reporting period thereafter, the Company assesses whether it should include development, regulatory, commercial milestones or other forms of variable consideration in the transaction price using the most likely amount method. The Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price. The Company includes the amount of estimated variable consideration, including milestones, in the transaction price to the extent that it is probable that a significant reversal of cumulative revenue recognized will not occur. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of the milestones and any related constraint, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which will affect revenue in the period of adjustment. In addition, the Company is eligible to receive certain royalties on net sales of licensed products if successfully commercialized by our licensees. The royalties are dependent on future sales, which are at the full discretion of the licensee. We will recognize sales-based milestone payments in the period in which we achieve the milestone under the sales-based royalty exception allowed under accounting rules. Accordingly, we will apply a constraint to these amounts until the future sales have occurred.

For arrangements with licenses of intellectual property that include sales-based royalties, including milestone payments based on the level of sales, and if the license is deemed to be the predominant item to which the royalties relate, the Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied.

Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s balance sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to receipt are recorded as contract assets in the Company’s balance sheets. If the Company expects to have an unconditional right to receive consideration in the next twelve months, this will be classified in current assets.

Net loss per share

Net loss per share attributable to common stockholders is calculated using the two-class method required for companies with participating securities. The Company considered its convertible preferred stock to be participating securities as the holders were entitled to receive noncumulative dividends in the event that a dividend is paid on common stock.

Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period less common shares subject to vesting or forfeiture, without consideration for potentially dilutive securities. In September 2025, the Company entered into a securities purchase agreement, or the Private Placement, pursuant to which the Company issued pre-funded warrants to purchase up to an aggregate of 5,231,090 shares of its common stock at a purchase price of $16.249 per pre-funded warrant, or the 2025 Pre-Funded Warrants. The 2025 Pre-Funded Warrants are exercisable immediately at an exercise price of $0.001 per share and do not expire. The Company included the 2025 Pre-Funded Warrants in the computation of basic net loss per share, as applicable, since their exercise price is negligible and they may be exercised at any time. See Note 6, Capital structure, for further discussion of the Private Placement.

Diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares and the number of common shares that would be issued assuming exercise and conversion of all potentially dilutive instruments. In calculating diluted net loss per share, the Company applies the treasury stock method to equity awards, if dilutive. Distributed and undistributed earnings are allocated to participating securities based on their participation rights and are subtracted from net income in determining net income attributable to common stockholders for basic and diluted net income per share, only in periods of net income.

Because the Company reported a net loss for the three months ended March 31, 2026 and 2025, and the inclusion of the potentially dilutive securities would be antidilutive, diluted net loss per share is the same as basic net loss per share for the periods presented.

Recently adopted accounting pronouncements

In July 2025, the Financial Accounting Standards Board, or FASB, issued ASU No. 2025-05, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, which provides a practical expedient that assumes that current conditions as of the balance sheet date do not change for the remaining life of the asset in developing reasonable and supportable forecasts during the application of the current expected credit loss model for current accounts receivable and current contract assets arising from transactions under ASC 606. The Company adopted ASU 2025-05 effective January 1, 2026. The Company determined there is no impact to its financial statements from adopting ASU 2025-05 as it does not develop forecasts as part of estimating expected credit losses.

New accounting pronouncements—Not yet adopted

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, which will require additional expense disclosures for all public entities. The amendments require that at each interim and annual reporting period, an entity will disclose certain disaggregated expenses included in each relevant expense caption, as well as the total amount of selling expenses and, in annual periods, an entity’s definition of selling expenses. ASU 2024-03 is effective for annual reporting periods beginning with the fiscal year ending December 31, 2027, and interim periods thereafter, with early adoption permitted. The Company expects the adoption of this standard to result in increased disclosures in its financial statements.

Fair value measurements

The following tables summarize the types of assets measured at fair value on a recurring basis by level within the fair value hierarchy.


	Fair value measurements
	(in thousands)
	Total		Level 1		Level 2		Level 3
As of March 31, 2026
Assets
Cash equivalents
Money market funds	$	62,199	$	62,199	$	—	$	—
Marketable securities
U.S. treasury securities		131,778		—		131,778		—
U.S. government agency securities		15,970		—		15,970		—
Commercial paper		5,928		—		5,928		—
Corporate debt securities		10,496		—		10,496		—
Restricted cash		1,088		1,088		—		—
Total assets measured at fair value	$	227,459	$	63,287	$	164,172	$	—

As of December 31, 2025
Assets
Cash equivalents
Money market funds	$	54,154	$	54,154	$	—	$	—
Marketable securities
U.S. treasury securities		139,453		—		139,453		—
U.S. government agency securities		23,476		—		23,476		—
Commercial paper		5,876		—		5,876		—
Corporate debt securities		1,979		—		1,979		—
Restricted cash		1,088		1,088		—		—
Total assets measured at fair value	$	226,026	$	55,242	$	170,784	$	—

There were no transfers between Level 1, 2, or 3 during the three months ended March 31, 2026 and 2025.

Marketable securities

All marketable securities were considered available-for-sale as of March 31, 2026 and December 31, 2025. On a recurring basis, the Company records its marketable securities at fair value using Level 1 or Level 2 inputs as discussed in Note 3, Fair value measurements. The amortized cost, unrealized holding gains, unrealized holding losses and fair value of the Company’s marketable securities by major security type as of March 31, 2026 and December 31, 2025 are summarized in the table below:


	As of March 31, 2026
	(in thousands)
	Amortized Cost		Unrealized Gains		Unrealized Losses			Aggregate Estimated Fair Value
Marketable securities, current
U.S. treasury securities	$	122,796	$	6	$	(92	)	$	122,710
U.S. government agency securities		15,981		—		(11	)		15,970
Commercial paper		5,931		—		(3	)		5,928
Corporate debt securities		9,028		—		(20	)		9,008
Total short-term marketable securities		153,736		6		(126	)		153,616
Marketable securities, non-current
U.S. treasury securities		9,082		—		(14	)		9,068
Corporate debt securities		1,489		—		(1	)		1,488
Total long-term marketable securities		10,571		—		(15	)		10,556
Total	$	164,307	$	6	$	(141	)	$	164,172

	December 31, 2025
	(in thousands)
	Amortized Cost		Unrealized Gains		Unrealized Losses			Aggregate Estimated Fair Value
Marketable securities, current
U.S. treasury securities	$	121,246	$	93	$	—		$	121,339
U.S. government agency securities		23,467		9		—			23,476
Commercial paper		5,874		2		—			5,876
Corporate debt securities		1,979		—		—			1,979
Total short-term marketable securities		152,566		104		—			152,670
Marketable securities, non-current
U.S. treasury securities		18,108		6		—			18,114
Total long-term marketable securities		18,108		6		—			18,114
Total	$	170,674	$	110	$	—		$	170,784

Interest receivable as of March 31, 2026 and December 31, 2025 was $1.8 million and $1.5 million, respectively, and is recorded as a component of prepaid expenses and other current assets on the Company’s condensed balance sheets.

As of March 31, 2026, 34 of the Company's marketable securities were in an unrealized loss position, and no marketable securities had been in continuous unrealized loss positions for 12 months or longer. The Company had not recognized an allowance for credit losses as of March 31, 2026 or December 31, 2025. The Company determined that it had the ability and intent to hold all marketable securities that have been in a continuous loss position until maturity or recovery. Further, a majority of the Company's investments were held in U.S. government securities, and the remainder were held with investment grade, high credit quality institutions. Moreover, the Company continues to receive payments of interest and principal as they become due, and the Company's expectation is that those payments will continue to be received timely. Based on this evaluation, as of March 31, 2026, the Company determined that unrealized losses of its marketable securities were primarily attributable to changes in interest rates and non-credit related factors. As of March 31, 2026, all of the Company’s marketable securities have a remaining contractual maturity of less than two years.

Balance sheet components

Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consisted of the following:


	As of March 31,		As of December 31,
	2026		2025
	(in thousands)
Accrued compensation expenses	$	5,415	$	10,853
Accrued research and development expenses		5,043		4,305
Accrued professional expenses		1,489		660
Other accrued expenses and current liabilities		438		149
Total accrued expenses and other current liabilities	$	12,385	$	15,967

Capital structure

2026 Sale Agreement

In February 2026, the Company entered into the 2026 Sale Agreement. See Note 1, Organization and principal activities, for further discussion of the 2026 Sale Agreement.

Private placement

In September 2025, the Company completed the Private Placement, pursuant to which the Company issued and sold an aggregate of 4,000,002 shares of its common stock at a purchase price of $16.25 per share and the 2025 Pre-Funded Warrants to purchase up to an aggregate of 5,231,090 shares of its common stock at a purchase price of $16.249 per pre-funded warrant, resulting in net proceeds of approximately $141.3 million, after deducting placement fees and other offering expenses paid by the Company of approximately $8.7 million. The 2025 Pre-Funded Warrants are exercisable immediately at an exercise price of $0.001 per share each and do not expire. The 2025 Pre-Funded Warrants provide that each holder of the 2025 Pre-Funded Warrants does not have the right to exercise any portion of its 2025 Pre-Funded Warrants if such holder, together with its affiliates, would beneficially own in excess of 4.99% or 9.99%, at the holder’s election, of the number of shares of the Company's common stock outstanding immediately after giving effect to such exercise. For the three months ended March 31, 2026 no 2025 Pre-Funded Warrants were exercised, and as of March 31, 2026, 2025 Pre-Funded Warrants to purchase 4,331,090 shares of the Company's common stock remained outstanding.

Upon the issuance of the 2025 Pre-Funded Warrants, the Company evaluated the warrant terms to determine the appropriate accounting and classification pursuant to Accounting Standards Codification 480, Distinguishing Liabilities from Equity, and Accounting Standards Codification 815, Derivatives and Hedging. Warrants are classified as liabilities when the warrant terms allow settlement of the warrant exercise in cash and classified as equity when the warrant terms only allow settlement in shares of common stock. The terms of the 2025 Pre-Funded Warrants include certain provisions related to fundamental transactions and a cashless exercise provision in the event registered shares are not available, and do not include any mandatory redemption provisions. Based on its evaluation, the Company concluded the 2025 Pre-Funded Warrants should be classified as equity with no subsequent remeasurement as long as such warrants continue to be classified as equity.

Equity incentive plans and stock-based compensation expense

2025 Equity Incentive Plan

The Company’s board of directors, or Board of Directors, and stockholders approved the 2025 Equity Incentive Plan, or 2025 Plan, which became effective on January 29, 2025. The 2025 Plan replaced the 2019 Equity Incentive Plan, or 2019 Plan, and upon its effectiveness, the Company ceased granting awards under the 2019 Plan. The 2025 Plan allows the Company to make equity-based and cash-based incentive awards to its officers, employees, directors and consultants. The Company initially reserved 5,300,000 shares of its common stock under the 2025 Plan plus those shares of common stock previously reserved but unissued under the 2019 Plan. Any outstanding awards granted under the 2019 Plan will remain subject to the terms of the 2019 Plan and applicable award agreements. The number of shares reserved for issuance under the 2025 Plan will increase automatically on January 1st each year from 2026 through 2035 by the number of shares equal to the lesser of 5% of the sum of (a) the total number of outstanding shares of all classes of the Company’s common stock plus (b) the total number of shares of the Company’s common stock subject to pre-funded warrants (if any) and (c) the total number of shares of the Company’s common stock issuable upon conversion of preferred stock (if any), in each case as of the immediately preceding December 31st, or a number as may be determined by the Board of Directors or compensation committee thereof. Accordingly, the Company’s common stock reserved for future issuance under the 2025 Plan was increased by 2,683,332 shares on January 1, 2026.

As of March 31, 2026, there was an aggregate of 6,074,793 options outstanding under the 2019 Plan and 2025 Plan and 1,042,855 restricted stock units, or RSUs, outstanding under the 2025 Plan.

2025 Employee Stock Purchase Plan

The Board of Directors and stockholders approved the 2025 Employee Stock Purchase Plan, or 2025 ESPP, which became effective on January 30, 2025. The number of shares initially available for issuance pursuant to the 2025 ESPP was 450,000 shares. The purchase price of common stock purchased under the 2025 ESPP is equal to 85% of the lesser of the fair market value of the Company’s common stock on (i) the first trading day of the applicable offering period or (ii) the last trading day of each purchase period in the applicable offering period. The aggregate number of shares reserved for sale under the 2025 ESPP will increase automatically on January 1st each year from 2026 through 2035 by the number of shares equal to 1% of the sum of (a) the total number of outstanding shares of all classes of the Company’s common stock plus (b) the total number of shares of the Company’s common stock subject to pre-funded warrants (if any) and (c) the total number of shares of the Company’s common stock issuable upon conversion of preferred stock (if any), in each case outstanding as of the immediately preceding December 31st, provided that the Board of Directors or compensation committee may in its sole discretion reduce the amount of the increase in any particular calendar year. Accordingly, the number of shares reserved for future issuance under the 2025 ESPP was increased by 536,666 shares on January 1, 2026. During the three months ended March 31, 2026, no shares were issued under the 2025 ESPP.

Stock-based compensation expense

The following table summarizes the components of stock-based compensation expense recognized in the Company’s condensed statements of operations and comprehensive loss during the three months ended March 31, 2026 and 2025:


	Three Months Ended March 31,
	2026		2025
	(in thousands)
Research and development	$	3,528	$	1,858
General and administrative		3,581		1,368
Total stock-based compensation expense	$	7,109	$	3,226

As of March 31, 2026, there was $58.0 million of total unrecognized compensation cost related to unvested options for which the cost is expected to be recognized over a weighted-average period of 2.88 years. As of March 31, 2026, there was $1.4 million of total unrecognized compensation cost related to the 2025 ESPP for which the cost is expected to be recognized over a weighted-average period of one year.

Total stock-based compensation expense related to RSUs recognized during the three months ended March 31, 2026 was $2.2 million and is included in the stock-based compensation expense table above. No stock-based compensation expense related to RSUs was recognized during the three months ended March 31, 2025. As of March 31, 2026, there was $30.3 million of total unrecognized compensation cost related to outstanding RSUs that is expected to be recognized over a weighted average period of 2.50 years.

License agreements

Trace License Agreement

In March 2024, the Company entered into an exclusive license agreement with Trace Neuroscience, Inc., or Trace, pursuant to which the Company granted an exclusive worldwide license to a discovery research program targeting UNC13A for the treatment of amyotrophic lateral sclerosis, or the Trace License Agreement. As consideration for the licensed rights and the transfer of know-how and materials, the Company received an upfront payment of $15.0 million in April 2024. Thereafter, the Company is entitled to potential subsequent payments of up to an aggregate of $80.0 million based on development and regulatory milestones and up to an aggregate of $250.0 million based on sales milestones. The Company is also entitled to tiered royalties ranging from percentages in the low single-digits to sub-teens on net sales of any licensed product if successfully commercialized.

The Company assessed the Trace License Agreement in accordance with ASC 606 and concluded that it was a contract with a customer. The Company determined that there is one performance obligation relating to the license to the UNC13A discovery program, including the underlying know-how and certain related materials, and that the transaction price consisted of the $15.0 million non-refundable upfront cash payment. The potential future development and regulatory milestones represent variable consideration and were constrained, as it was concluded that it was not probable that a significant reversal in cumulative revenue recognized will not occur and therefore not included in the transaction price as of March 31, 2026. Potential sales milestones and royalties on net product sales will be recognized in the same period that the underlying net product sales occur as they were determined to relate to the license. The $15.0 million transaction price was recorded as license revenue in the condensed statements of operations and comprehensive loss during the year ended December 31, 2024, at the point in time when control of the license and related know-how was transferred to Trace.

Shionogi License Agreement

In March 2024, the Company entered into an exclusive license agreement with Shionogi, pursuant to which the Company granted Shionogi an exclusive, worldwide, sublicensable license to research, develop, manufacture and commercialize MZE001 and certain other small molecule compounds modulating glycogen synthase 1, or the Shionogi License Agreement. As consideration for the licensed rights and the transfer of know-how and materials, the Company received an upfront payment of $150.0 million in May 2024 upon the effectiveness of the Shionogi License Agreement. The Shionogi License Agreement also requires that Shionogi pay the Company up to $275.0 million in the aggregate in milestone payments upon the completion of certain clinical and regulatory milestones and up to $330.0 million in the aggregate in milestone payments if certain sales milestones are achieved. In March 2026, a $20.0 million clinical development milestone was achieved upon dosing of the first patient in Shionogi's Phase 2 study of MZE001 in patients with Pompe disease. The Company recognized $20.0 million as license revenue in the condensed statements of operations and comprehensive loss for the three months ended March 31, 2026 in connection with the achievement of the clinical development milestone and recorded a corresponding receivable on its condensed balance sheet in accounts receivable as of March 31, 2026. The Shionogi License Agreement also requires that Shionogi pay the Company tiered royalties ranging from percentages in the low double-digits to twenty on net sales of licensed products, subject to certain deductions. See Note 13, Subsequent events, for further discussion regarding the first clinical development milestone achieved under the Shionogi License Agreement.

The Company assessed the Shionogi License Agreement in accordance with ASC 606 and concluded that it was a contract with a customer. The Company determined that there is one performance obligation relating to the license to the MZE001 program, including the underlying know-how and certain related materials, and that the transaction price at the inception of the Shionogi License Agreement consisted of the $150.0 million non-refundable upfront cash payment, which was recognized as license revenue in the condensed statements of operations and comprehensive loss during the year ended December 31, 2024 at the point in time when control of the license and related know-how and materials was transferred to Shionogi. The $20.0 million clinical development milestone was recognized as license revenue upon its achievement in March 2026. The remaining potential clinical and regulatory milestones represent variable consideration and were constrained as it was concluded that it was not probable that a significant reversal in cumulative revenue recognized will not occur and therefore are not included in the transaction price as of March 31, 2026. Potential sales milestones and royalties on net product sales will be recognized in the same period that the underlying net product sales occur as they were determined to relate to the license.

Neurocrine License Agreement

In May 2024, the Company entered into an exclusive license agreement with Neurocrine Biosciences, Inc., or Neurocrine, pursuant to which the Company granted Neurocrine an exclusive worldwide license to a discovery research program targeting ATXN2, or the Neurocrine License Agreement. As consideration for the licensed rights and the transfer of know-how and materials, the Company received an upfront payment of $2.5 million in June 2024. Thereafter, the Company is entitled to potential subsequent payments of up to an aggregate of $24.8 million based on research and development milestones and up to an aggregate of $175.0 million based on sales milestones. The Company is also entitled to tiered royalties ranging in the sub-single-digit to low single-digit percentages on net sales of any licensed product if successfully commercialized.

The Company assessed the Neurocrine License Agreement in accordance with ASC 606 and concluded that it was a contract with a customer. The Company determined that there is one performance obligation relating to the license to the ATXN2 discovery program, including the underlying know-how and certain related materials, and that the transaction price consisted of the $2.5 million upfront cash payment. The potential research and development milestones represent variable consideration and were constrained as it was concluded that it was not probable that a significant reversal in cumulative revenue recognized will not occur and therefore not included in the transaction price as of March 31, 2026. Potential sales milestones and royalties on net product sales will be recognized in the same period that the underlying net product sales occur as they were determined to relate to the license. The $2.5 million transaction price was recorded as license revenue in the condensed statements of operations and comprehensive loss during the year ended December 31, 2024, at the point in time when control of the license and the related know-how and materials was transferred to Neurocrine.

Commitments and contingencies

Legal proceedings

From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. No contingent liabilities have been recorded as of March 31, 2026 and December 31, 2025.

Indemnification

In accordance with the Company’s amended and restated certificate of incorporation and amended and restated bylaws, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. There have been no claims to date, and the Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for future claims.

10.

Loan and security agreements

Hercules Loan and Security Agreement

On February 4, 2026, or the Closing Date, the Company entered into the Hercules Loan Agreement. The Hercules Loan Agreement provides for a senior secured term loan facility in an aggregate principal amount of up to $200.0 million, or the Hercules Term Loan Facility. An initial term loan of $40.0 million, or the Tranche 1A Loan, was funded under the Hercules Term Loan Facility on the Closing Date. In addition to the Tranche 1A Loan, the Hercules Term Loan Facility includes up to six additional term loan tranches providing up to an aggregate $160.0 million in additional loan commitments (collectively with the Tranche 1A Loan, the Term Loans). The final tranche of $50.0 million will be available subject to future approval by the lenders’ investment committee. The tranches will be available up to 60 months after the Closing Date, so long as the Company satisfies certain conditions precedent, including compliance with financial covenants, the continued accuracy of the representations and warranties provided in the Hercules Loan Agreement and satisfaction of certain performance and financing milestones.

The Hercules Term Loan Facility has a maturity date of February 1, 2031, or the Maturity Date. Upon repayment of the Term Loans (whether at the Maturity Date or upon earlier prepayment), the Company is required to pay an exit fee, or the End of Term Charge, equal to (i) 3.95% of the principal amount being repaid, if repaid on or within 24 months of the Closing Date, (ii) 5.75% of the principal amount being repaid, if repaid more than 24 months after the Closing Date and on or within 48 months of the Closing Date, and (iii) 6.45% of the principal amount being repaid, if repaid thereafter. In addition, the Hercules Loan Agreement required the Company to pay a facility charge of 1.00% of the funded Tranche 1A Loan, which was due at the Closing Date, and requires a facility charge of 1.00% for each subsequent term loan tranche at the time such tranche is funded. The Company also paid a draw down fee of 2.00% of the funded Tranche 1A Loan and is required to pay sequent draw down fees equal to 2.00% of each subsequent term loan tranche at the time such tranche is funded.

The Hercules Term Loan Facility will accrue interest at an annual rate determined by reference to the Prime Rate as reported in the Wall Street Journal, with interest rate floors that range from 7.95% (with respect to the Tranche 1A Loan funded on the Closing Date, among other tranches) to 9.25% depending on the tranche. The Hercules Term Loan Facility provides for payment of interest only until (a) 48 months after the Closing Date or (b) if certain performance and financing milestones are satisfied, 60 months after the Closing Date. Accrued interest on the Term Loans is payable on the first business day of each month. Upon an Event of Default (as defined in the Hercules Loan Agreement), the interest rate will automatically increase by an additional 4.00% per annum.

The Term Loans may be prepaid at any time, subject to a prepayment premium equal to (i) 3.00% of the aggregate outstanding principal amount being prepaid, if prepaid on or within 12 months of the Closing Date; (ii) 2.00% of the aggregate outstanding principal amount being prepaid, if prepaid more than 12 months after the Closing Date and on or within 24 months of the Closing Date; (iii) 1.00% of the aggregate outstanding principal amount being prepaid, if prepaid more than 24 months after the Closing Date and on or within 36 months of the Closing Date; and (iv) 0.00% thereafter, and the End of Term Charge described above.

Pursuant to the Hercules Loan Agreement, all of the Company’s obligations under the Hercules Loan Agreement are secured by a first lien perfected security interest on substantially all of the Company’s existing and after-acquired assets, subject to customary exceptions.

The Hercules Loan Agreement contains certain representations and warranties, affirmative covenants, negative covenants, financial covenants, and conditions that are customarily required for similar financings. In addition, unless either (i) the Company’s market capitalization is greater than or equal to $450.0 million and an aggregate of no more than $85.0 million in principal amount is outstanding under the Term Loans or (ii) the Company’s market capitalization is greater than or equal to $750.0 million, the Company must at all other times maintain unrestricted cash and cash equivalents of at least 50% of the outstanding loan amount, decreasing to 40% and 35% upon satisfaction of certain performance and financing milestones.

The Hercules Loan Agreement also contains certain customary Events of Default which include, among others, non-payment of principal, interest, or fees, violation of covenants, inaccuracy of representations and warranties, bankruptcy and insolvency events, material judgments, cross-defaults to material contracts, certain material regulatory-related events and events constituting a change of control. The occurrence of an Event of Default could result in, among other things, the declaration that all outstanding principal and interest under the Hercules Term Loan Facility are immediately due and payable in whole or in part. As of March 31, 2026, the Company was in compliance with the covenants under the Hercules Loan Agreement.

The Company accounted for the End of Term Charge, facility charge, and other direct costs incurred in connection with the Tranche 1A Loan of the Hercules Loan Agreement as debt discount and issuance costs, and they are being amortized over the term of the loan using the effective interest method. The weighted-average effective interest rate on the Tranche 1A Loan is 9.77%.

The Company incurred interest expense on the Tranche 1A Loan, including debt discount and issuance costs amortization, of $0.9 million during the three months ended March 31, 2026.

The Tranche 1A Loan consists of the following:


	As of March 31,
	2026
	(in thousands)
Term loan principal amount	$	40,000
End of term charge		2,580
Unamortized discount and issuance costs		(3,747	)
Total term loan		38,833
Less: current portion of term loan		—
Total term loan, net of current portion	$	38,833

Future principal loan payments on the currently outstanding Tranche 1A Loan as March 31, 2026 are as follows:


Year Ending December 31,	Amount
	(in thousands)
2026	$	—
2027		—
2028		—
2029		—
2030		33,602
2031		6,398
Total future principal payments		40,000
Add: end of term charge		2,580
Less: unamortized discount and issuance costs		(3,747	)
Less: current portion of term loan		—
Total term loan, net of current portion	$	38,833

Banc of California Loan and Security Agreement

In connection with the Company’s entry into the Hercules Loan Agreement, the loan and security agreement for a $50.0 million revolving line of credit with Banc of California dated June 27, 2022, as amended in March 2025, was terminated, effective as of February 2, 2026, and the lender’s security interest in the Company’s assets and property was released.

11.

Related party transactions

The Company has paid fees to its founders and certain board members in exchange for consulting services. During the three months ended March 31, 2026 and 2025, the Company recorded an immaterial amount of such fees in general and administrative expenses in the condensed statements of operations and comprehensive loss.

12.

Net loss per share

The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data):


	Three Months Ended March 31,
	2026			2025
Numerator:
Net loss	$	(24,208	)	$	(32,786	)
Denominator:
Weighted-average shares of common stock outstanding		53,907,588			28,638,802
Less: weighted-average shares of common stock subject to repurchase		(10,372	)		(10,372	)
Weighted-average shares of common stock outstanding used in the calculation of net loss per share, basic and diluted		53,897,216			28,628,430
Net loss per share, basic and diluted	$	(0.45	)	$	(1.15	)

The potential shares of common stock that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive are as follows:


	Three Months Ended March 31,
	2026		2025
Shares subject to outstanding stock options		6,074,793		5,277,288
Shares subject to outstanding restricted stock units		1,042,855		—
Unvested restricted stock subject to repurchase		10,372		10,372
Total		7,128,020		5,287,660

13.

Subsequent events

Underwritten Registered Offering

In April 2026, the Company completed an underwritten registered offering pursuant to which the Company issued and sold an aggregate of 5,540,000 shares of its common stock at $23.50 per share and pre-funded warrants to purchase 850,000 shares of its common stock at $23.499 per pre-funded warrant, or the 2026 Pre-Funded Warrants, which represents the per share offering price for the shares of common stock less a $0.001 per share exercise price for each 2026 Pre-Funded Warrant. The Company estimates that net proceeds from the offering will be approximately $144.7 million, after deducting underwriting discounts and commissions and estimated offering expenses.

The 2026 Pre-Funded Warrants are exercisable immediately at an exercise price of $0.001 per share and do not expire. The 2026 Pre-Funded Warrants provide that each holder of the 2026 Pre-Funded Warrants does not have the right to exercise any portion of its 2026 Pre-Funded Warrants if such holder, together with its affiliates, would beneficially own in excess of 4.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise. A holder of the 2026 Pre-Funded Warrants may increase or decrease this percentage, but not in excess of 19.99%, by providing at least 61 days’ prior notice to the Company.

Shionogi Milestone Payment

In April 2026, the Company received the $20.0 million payment from Shionogi in connection with the achievement of the clinical development milestone in March 2026 for the dosing of the first patient in Shionogi’s Phase 2 study of MZE001 in patients with Pompe disease.

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

The following discussion should be read in conjunction with the unaudited condensed financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q; and the sections entitled “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in our Annual Report on Form 10-K for the year ended December 31, 2025 as filed with the SEC on March 25, 2026, or 2025 Form 10-K.

Overview

We are a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with kidney and metabolic diseases. We are advancing a pipeline using our Compass platform, which allows us to identify and characterize genetic variants associated with health and disease and then determine how these drive risk for and protection against disease in specific patient groups through a process we refer to as variant functionalization. Our Compass platform has been purpose-built to inform all phases of our drug discovery and development process through clinical trial design. We are currently advancing two wholly-owned clinical programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach. Our goal is to bring novel precision medicines to patients with kidney and metabolic diseases, which is where we believe we can maximize our impact on human health.

Our most advanced program, MZE829, is an oral, small molecule inhibitor of apolipoprotein L1, or APOL1, for the treatment of patients with APOL1-mediated kidney disease, or AMKD, a genetically defined sub-set of chronic kidney disease, or CKD, for which there is no approved treatment today. We initiated a Phase 2 trial of MZE829 in November 2024 and dosed our first patient in February 2025. In March 2026, we announced positive topline clinical proof of concept data from our Phase 2 trial of MZE829 in patients with AMKD, in which we enrolled 15 patients. The results demonstrated that treatment with MZE829 led to a clinically meaningful mean reduction in proteinuria, as measured by urinary albumin-to-creatinine ratio. MZE829 was generally well tolerated, with no serious adverse events or severe treatment-related adverse events reported. We plan to continue enrollment in the Phase 2 trial and to advance MZE829 into a pivotal development program. We anticipate reporting additional data from the Phase 2 trial in late 2026 or early 2027.

Our second program, MZE782, is an oral, small molecule inhibitor for the treatment of patients with phenylketonuria, or PKU, an inherited metabolic disorder, and for patients with CKD. In September 2025, we reported results from our Phase 1 clinical trial of MZE782, in which we enrolled 112 healthy adult volunteers. MZE782 was well tolerated across all doses in all cohorts and demonstrated a favorable pharmacokinetics profile after single and multiple oral doses. MZE782 produced dose-dependent increases in 24-hour urinary excretion of the neutral amino acids phenylalanine and glutamine across both single ascending dose and multiple ascending dose cohorts, confirming target engagement and SLC6A19 inhibition. We also observed dose-dependent changes in estimated glomerular filtration rate in healthy individuals with MZE782, similar to those seen with SGLT2 inhibitors, suggesting a potential beneficial effect on kidney physiology in CKD patients. We plan to initiate Phase 2 proof-of-concept trials of MZE782 in patients with PKU by mid-2026 and in patients with CKD in the second half of 2026. We anticipate reporting topline data from the Phase 2 trial of MZE782 in patients with PKU in 2027.

Since our inception, we have focused substantially all of our efforts and financial resources on research and development activities for our programs and on establishing arrangements and collaborations with third parties for the development of our therapeutic candidates. To date, we have not generated any revenue from product sales and have financed our operations primarily through sales of our equity and convertible promissory notes, debt financing, as well as one-time, nonrefundable upfront payments we received pursuant to the license agreements we entered into with several biotechnology companies in 2024, including the exclusive license agreement with Shionogi & Company, Ltd., or Shionogi. We do not expect to generate any revenue from commercial sales for the foreseeable future. We expect to continue incurring significant operating losses for the foreseeable future due to the cost of research and development, clinical trials, preclinical studies and the regulatory approval process for our therapeutic candidates.

We have incurred significant losses and negative cash flows from operations and we expect to incur significant and increasing losses for the foreseeable future as a result of our continued research and development activities. During the three months ended March 31, 2026 and 2025, we incurred a net loss of $24.2 million and $32.8 million, respectively. As of March 31, 2026, we had an accumulated deficit of $513.8 million and do not expect positive cash flows from operations for the foreseeable future. Our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities, as well as upon revenue from our license agreements. We expect our research and development expenses to significantly increase in connection with the conduct of planned clinical trials for our lead programs, MZE829 and MZE782, further development of our Compass platform, planned preclinical studies, and potential Investigational New Drug Applications, or INDs, and clinical trials for future therapeutic candidates. We will also incur substantial additional expenses as we seek to expand our intellectual property portfolio, including through potential in-licensing opportunities, and hire additional personnel as we scale up our operations. In addition, we expect to incur additional costs associated with operating as a public company.

As of March 31, 2026, we had cash, cash equivalents and marketable securities of $362.9 million. Since our inception, we have financed our operations primarily through issuances of our equity and convertible promissory notes, debt financing, and license agreements with biotechnology companies.

We will require substantial additional capital to develop our therapeutic candidates and fund operations for the foreseeable future. Until such time as we can generate sufficient revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings, debt financings, collaborations and licensing arrangements.

Adequate additional financing may not be available to us on favorable terms, or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. If we are unable to raise capital when needed or on favorable terms, we could be forced to delay, reduce or eliminate our clinical and preclinical development, research and development programs, our commercialization plans or other operations. The amount and timing of our future funding requirements will depend on many factors including the pace and results of our development efforts. We cannot assure that we will ever be profitable or generate positive cash flows from operating activities.

We selectively pursue strategic collaborations related to the development of certain targets, therapeutic programs, or disease areas where we believe third-party expertise or resources could be beneficial. In 2020, we formed a spin-out company, Broadwing Bio LLC, or Broadwing, with Alloy Therapeutics, Inc., or Alloy, to develop therapeutic antibody therapies for ANGPTL7 and another undisclosed target in ophthalmic diseases, informed by our Compass platform. As of March 31, 2026, we owned approximately 48% of the outstanding equity of Broadwing, and we expect our ownership to be significantly diluted upon the conversion of outstanding convertible notes issued by Broadwing. We retain certain opt-in rights to jointly develop and commercialize certain therapeutic candidates developed through Broadwing with Alloy. We are not involved in the development of Broadwing’s therapeutic candidate.

Exclusive license agreement with Shionogi

In March 2024, we entered into an exclusive license agreement, or the License Agreement, with Shionogi, pursuant to which we granted Shionogi an exclusive, worldwide, sublicensable license to research, develop, manufacture and commercialize MZE001 and certain other small molecule compounds modulating glycogen synthase 1, or the Licensed Products. As consideration for the licensed rights and the transfer of know-how and materials, we received an upfront payment of $150.0 million in May 2024 upon the effectiveness of the License Agreement. The License Agreement also requires that Shionogi pay us up to $275.0 million in the aggregate in milestone payments upon the completion of certain clinical and regulatory milestones and up to $330.0 million in the aggregate in milestone payments if certain sales milestones are achieved. In April 2026, we received $20.0 million following the achievement of a clinical development milestone upon dosing of the first patient in Shionogi's Phase 2 study of MZE001 in patients with Pompe disease. The License Agreement also requires that Shionogi pay us tiered royalties ranging from percentages in the low double-digits to twenty on net sales of Licensed Products, subject to certain deductions.

The License Agreement will expire on a Licensed-Product by Licensed-Product and country-by-country basis upon the expiration of the royalty term for such Licensed Product, which will be the latest of the date when there are no remaining valid claims covering the applicable Licensed Product, the expiration of regulatory exclusivity for the applicable Licensed Product, or 11 years after the first commercial sale of the applicable Licensed Product, subject to earlier termination by the parties. As of March 31, 2026, we estimate that the last patent right for the only currently issued patent licensed under the License Agreement will expire in 2042, without giving effect to any potential patent term extensions, patent term adjustments, or future patents that may or may not issue with respect to the Licensed Products. Upon expiration of the License Agreement, the licenses granted to Shionogi will become fully paid-up, perpetual, irrevocable and royalty-free. Shionogi may terminate the License Agreement for convenience following a notice period and either party may terminate the License Agreement for bankruptcy or an uncured material breach. Upon termination of the License Agreement by Shionogi for convenience or by us for Shionogi’s bankruptcy or uncured material breach, Shionogi will grant us a non-exclusive, worldwide license under certain patent rights and know-how controlled by Shionogi as of the effective date of termination, solely as necessary to research, develop, manufacture and commercialize the Licensed Products in any field, and Shionogi will assign to us all regulatory materials and regulatory approvals relating to the Licensed Products. In consideration for these reversion rights, we would be required to pay to Shionogi reversion royalties on any sales of the Licensed Products determined based on the stage of clinical development of the applicable Licensed Product at the time of termination, ranging from percentages in the low-to-mid single digits if termination occurs on or after the achievement of certain Phase 2 clinical trial milestones and high single digit to mid-teens if termination occurs on or after the achievement of certain Phase 3 clinical milestones. Our obligation to pay these reversion royalties would expire on a Licensed-Product by Licensed-Product and country-by-country basis upon the latest of the date when there are no remaining valid claims covering the applicable Licensed Product, the expiration of regulatory exclusivity for the applicable Licensed Product, or ten years after the first commercial sale of the applicable Licensed Product.

Components of results of operations

License revenue

We recognize revenue from the various license agreements we have entered into as the identified performance obligations under these arrangements are satisfied. We are also eligible to receive future non-refundable, non-creditable milestone payments upon the achievement of certain development, regulatory, and commercial milestones. Additionally, we are also eligible to receive certain royalties on net sales of products developed under the license agreements.

Operating expenses

Our operating expenses since inception have consisted solely of research and development expenses and general and administrative expenses.

Research and development expenses

Our research and development expenses consist primarily of external and internal expenses incurred in connection with our research activities and preclinical and clinical development programs. These expenses include, but are not limited to:

•

salaries, benefits and other employee-related costs, including stock-based compensation expense, for personnel engaged in research and development functions;

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fees paid to vendors that conduct certain research and development activities on our behalf;

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fees paid to contract manufacturing organizations, or CMOs, in connection with the production of research products and clinical trial materials;

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fees paid to clinical research organizations, or CROs, in connection with clinical trials as well as preclinical and toxicology studies;

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other expenses associated with laboratory supplies and other materials;

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professional service fees for consulting and related services; and

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facility costs, depreciation, and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and other supplies.

We recognize research and development expenses as they are incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are capitalized and expensed as the goods are delivered or the related services are performed. We have not historically disclosed our direct costs between our clinical programs and our preclinical programs.

Additionally, our internal costs, employees and infrastructure are not directly tied to any one program and are deployed across multiple programs. As such, we do not track indirect costs on a specific program basis.

At this time, we cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, MZE829, MZE782 and any of our other potential therapeutic candidates.

Our research and development expenses may vary significantly based on a variety of factors, such as:

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the timing and progress of clinical development activities for our therapeutic candidates;

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the timing and progress of preclinical development activities;

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the number and scope of preclinical and clinical programs we decide to pursue;

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our ability to hire clinical, regulatory, manufacturing, quality assurance and scientific personnel;

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potential additional trials requested by regulatory agencies;

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the costs and fees associated with the discovery, acquisition or in-license of our products or technologies, including to maintain and expand our Compass platform;

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our ability to establish clinical manufacturing capabilities or secure adequate supply of product from third-party manufacturers;

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the extent to which we establish additional strategic collaborations or other arrangements; and

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the impact of any business interruptions to our operations or to those of the third parties with whom we work.

A change in the outcome of any of these and other variables with respect to the development of any of our therapeutic candidates could significantly change the costs and timing associated with the development of such therapeutic candidate. We expect that our research and development expenses will continue to increase substantially for the foreseeable future as we continue to identify and develop potential additional therapeutic candidates and as our existing therapeutic candidates, including MZE829 and MZE782, move into later stages of clinical development, which typically have higher development costs than those in earlier stages of clinical development or preclinical development due to the increased size and duration of later-stage clinical trials.

The process of conducting the necessary preclinical and clinical research and development to obtain regulatory approval is costly and time-consuming and the successful development of our therapeutic candidates is highly uncertain. The actual probability of success for our therapeutic candidates may be affected by a variety of factors. We may never succeed in achieving regulatory approval for any of our therapeutic candidates. Further, a number of factors, including those outside of our control, could adversely impact the timing and duration of our therapeutic candidates’ development, which could increase our research and development expenses.

General and administrative expenses

General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits, and stock-based compensation expense, for personnel in executive, finance, accounting, corporate development, and other administrative functions. General and administrative expenses also include legal fees, professional fees paid for accounting, auditing, consulting, tax, and investor relations services, insurance costs, and facility costs not otherwise included in research and development expenses, and public company expenses such as costs associated with compliance with the rules and regulations of the Securities and Exchange Commission, or SEC, and Nasdaq.

We expect that our general and administrative expenses will continue to increase significantly in the foreseeable future as additional administrative personnel and services are required to manage these functions associated with being a public company and as our pipeline of therapeutic candidates expands.

Total other income, net

Total other income, net, primarily consists of interest income earned on our cash, cash equivalents and marketable securities and interest expense recognized on the loan and security agreement, or the Hercules Loan Agreement, with certain lenders and Hercules Capital, Inc. We expect total other income, net to increase as a result of additional interest income on the proceeds received from the initial term loan of $40.0 million under the Hercules Loan Agreement and the estimated net proceeds of approximately $144.7 million from the underwritten registered offering completed in April 2026, which is expected to be partially offset by interest expense recognized on the Hercules Loan Agreement. However, other income, net may vary each reporting period depending on our average cash deposits, money market fund and other investment balances during the period, prevailing market interest rates and the amount of interest expense incurred under the Hercules Loan Agreement.

Results of operations

Comparisons of the three months ended March 31, 2026 and 2025


	Three Months Ended March 31,
	2026			2025			Change
	(in thousands)
License revenue	$	20,000		$	—		$	20,000
Operating expenses:
Research and development		34,148			27,580			6,568
General and administrative		12,405			7,821			4,584
Total operating expenses		46,553			35,401			11,152
Loss from operations		(26,553	)		(35,401	)		8,848
Other income (expense):
Interest and other income, net		3,211			2,615			596
Interest expense		(866	)		—			(866	)
Total other income, net		2,345			2,615			(270	)
Net loss	$	(24,208	)	$	(32,786	)	$	8,578

License revenue

We recognized $20.0 million in license revenue for the three months ended March 31, 2026. We recognized no license revenue for the three months ended March 31, 2025. License revenue recognized in 2026 was related to achievement of a clinical development milestone upon dosing of the first patient in Shionogi's Phase 2 study of MZE001 in patients with Pompe disease under the License Agreement with Shionogi.

Research and development expenses

Research and development expenses were $34.1 million and $27.6 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $6.6 million between the comparative three month periods was primarily due to an increase of $3.6 million in personnel-related costs due to an increase in headcount and higher non-cash stock-based compensation expense, an increase of $1.9 million in clinical trial expenses based on the progression of our Phase 2 clinical trial for MZE829 in AMKD and start-up activities for our planned Phase 2 clinical trial for MZE782 in PKU, and higher costs for outside research and development services of $0.9 million to support our research programs.


	Three Months Ended March 31,
	2026		2025		Change
	(in thousands)
Personnel-related costs	$	13,991	$	10,344	$	3,647
Clinical trial expenses		7,576		5,676		1,900
Outside research and development services		5,829		4,921		908
Manufacturing expenses		1,792		1,187		605
Facilities, depreciation and other expenses		4,960		5,452		(492	)
Total research and development expenses	$	34,148	$	27,580	$	6,568

General and administrative expenses

General and administrative expenses were $12.4 million and $7.8 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $4.6 million between the comparative three month periods was primarily due to an increase of $3.3 million in personnel-related costs due to an increase in headcount and higher non-cash stock-based compensation expense, higher costs for professional services of $0.8 million and higher facilities and other costs of $0.3 million.

Total other income, net

Total other income, net was $2.3 million and $2.6 million for the three months ended March 31, 2026 and 2025, respectively. The decrease of $0.3 million between the comparative three months periods primarily reflects interest expense recognized on the Hercules Loan Agreement, partially offset by an increase in interest income as a result of higher cash, cash equivalent, and marketable securities balances held during the three months ended March 31, 2026 resulting from the net proceeds received from the securities purchase agreement we entered into in September 2025 and proceeds from the initial term loan funded under the Hercules Loan Agreement in February 2026.

Liquidity and capital resources

Liquidity

Since our inception, we have not generated any revenue from product sales and we do not expect to generate any revenue from commercial sales for the foreseeable future, if at all. We have incurred significant operating losses and negative cash flows from operations. We anticipate that we will continue to incur net losses for the foreseeable future. To date, we have financed our operations primarily through sales of our equity and convertible promissory notes, debt financing, as well as one-time, nonrefundable upfront licensing payments. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $362.9 million and an accumulated deficit of $513.8 million.

In February 2026, we entered into an Open Market Sale Agreement with Jefferies LLC, serving as sales agent, with respect to an at-the-market offering program pursuant to which we may elect to issue and sell shares of our common stock having an aggregate offering price of up to $200.0 million, or the 2026 Sale Agreement, in such quantities and on such minimum price terms as we set from time to time through our sales agent. We have agreed to pay our sales agent an aggregate commission equal to up to 3.0% of the gross proceeds of the sales under the agreement. To date, no sales of common stock have occurred under the 2026 Sale Agreement.

Additionally, in February 2026, we entered into the Hercules Loan Agreement which provides for a senior secured term loan facility in an aggregate principal amount of up to $200.0 million. An initial term loan of $40.0 million was funded under the Hercules Loan Agreement and an aggregate of $160.0 million in additional term loans commitments will be available to us through February 2031, so long as we satisfy certain conditions precedent. The final tranche of $50.0 million is subject to approval by the lenders’ investment committee. The facility has a maturity date of February 1, 2031, and may be prepaid at any time, subject to prepayment premiums. This senior secured term facility will accrue interest at an annual rate determined by reference to the Prime Rate as reported in the Wall Street Journal, with interest rate floors that range from 7.95% to 9.25% depending on the tranche. Accrued interest is payable on the first business day of each month until (a) February 2030 or (b) if certain performance and financing milestones are satisfied, the maturity date. In connection with the Hercules Loan Agreement, we terminated an existing loan and security agreement with another bank that provided us with a line of credit of up to $50.0 million. We did not draw down any funds from this terminated debt facility. See Note 10, Loan and security agreements, of this Quarterly Report on Form 10-Q for further discussion of the Hercules Loan Agreement.

In April 2026, we completed an underwritten registered offering pursuant to which we issued and sold an aggregate of 5,540,000 shares of our common stock at $23.50 per share and pre-funded warrants to purchase 850,000 shares of our common stock at $23.499 per pre-funded warrant, which represents the per share offering price for the shares of common stock less a $0.001 per share exercise price for each pre-funded warrant, resulting in estimated net proceeds of approximately $144.7 million, after deducting underwriting discounts and commissions and estimated offering expenses, or the Underwritten Registered Offering. See Note 13, Subsequent events, of this Quarterly Report on Form 10-Q for further discussion of the Underwritten Registered Offering.

Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations for at least one year from the date of this Quarterly Report on Form 10-Q. We have based this estimate on our current assumptions, which may prove to be wrong, and we may exhaust our available capital resources sooner than we expect.

Funding requirements

We do not expect to generate any meaningful future revenue unless and until we obtain regulatory approval and commercialize any of our current or future therapeutic candidates, including MZE829 and MZE782, or receive additional potential revenue from the achievement of milestones and royalties under our existing license agreements or potential additional partnerships, and we do not know when, or if at all, that will occur. We will continue to require additional capital to develop our therapeutic candidates and fund operations for the foreseeable future. Our primary uses of cash are to fund our operations, which consist primarily of research and development expenses related to our programs, and to a lesser extent, general and administrative expenses. We expect our expenses to continue to increase in connection with our ongoing activities as we continue to develop MZE829, MZE782 and our other discovery and preclinical programs, seek to broaden the pipeline of our product candidates and further develop our Compass platform. In addition, we expect to incur additional costs associated with operating as a public company.

We may seek to raise capital through equity or debt financings, license and collaboration agreements or other arrangements, or through other sources of financing. Adequate additional funding may not be available to us on acceptable terms or at all. Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. We anticipate that we will need to raise substantial additional capital, the requirements of which will depend on many factors, including:

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the costs associated with the type, scope, progress and results of research and discovery, preclinical development, laboratory testing and clinical trials for our current or future therapeutic candidates, including MZE829 and MZE782;

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the extent to which we develop, in-license or acquire other pipeline therapeutic candidates or technologies;

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the number and development requirements of other therapeutic candidates that we may pursue, and other indications for our current therapeutic candidates that we may pursue;

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the costs related to entering into partnerships or other arrangements with third parties;

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the costs, timing and outcome of obtaining regulatory approvals of our current or future therapeutic candidates we may pursue;

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the costs and fees associated with the discovery, acquisition or in-license of our products or technologies, including to maintain and expand our Compass platform;

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the scope and costs of making arrangements with third-party manufacturers for preclinical, clinical and commercial supplies of our current or future therapeutic candidates;

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the scope and costs involved in growing our organization to the size needed to allow for the research, development and potential commercialization of our current or future therapeutic candidates;

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the cost associated with commercializing any approved therapeutic candidates, including establishing sales, marketing and distribution capabilities;

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the cost associated with completing any post-marketing studies or trials required by the U.S. Food and Drug Administration, or FDA, or other regulatory authorities;

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the revenue, if any, received from commercial sales of our current or future therapeutic candidates, if any are approved;

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the costs associated with addressing any potential interruptions or delays resulting from factors related to overall global affairs, such as conflicts overseas;

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the costs and timing of preparing, filing and prosecuting patent applications, maintaining, defending and enforcing our intellectual property and proprietary rights and defending intellectual property-related claims that we may become subject to, including any litigation costs and the outcome of such litigation;

•

the costs associated with potential product liability claims, including the costs associated with obtaining insurance against such claims and with defending against such claims; and

•

our ability to establish and maintain collaboration arrangements on favorable terms, if at all and the timing and amount of any milestone, royalty or other payments we are required to make or are eligible to receive under such collaborations, if any.

If we raise additional funds by issuing equity securities, our stockholders will experience dilution. If we raise additional capital through debt financing, we may be subject to covenants that restrict our operations including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments, and engage in certain merger, consolidation or asset sale transactions. Any debt financing that we raise or additional equity that we issue may contain terms that are not favorable to us or our stockholders.

If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our proprietary technology, future revenue streams, research programs or therapeutic candidates, including granting licenses to our proprietary technologies, on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or collaborations, strategic alliances or licensing arrangements with third parties when needed, we may be required to delay, limit, reduce and/or terminate our product development programs or any future commercialization efforts or grant rights to develop and market therapeutic candidates that we would otherwise prefer to develop and market ourselves.

Contractual obligations and commitments

We have an operating lease for a facility in South San Francisco, California with office and laboratory space, which serves as our corporate headquarters. The lease terminates in November 2030 and provides for one option to extend the lease term for an additional period of eight years.

We have entered into consortium agreements with the University of Helsinki to access genomic information from patient samples and genetic and paired clinical data. As of March 31, 2026, we are obligated to pay $3.8 million under these agreements through the year ended December 31, 2027.

We are obligated to make principal loan payments, interest payments and pay an end of term charge under the Hercules Loan Agreement. See Note 10, Loan and security agreements, of this Quarterly Report on Form 10-Q for further discussion of the Hercules Loan Agreement.

We enter into contracts in the normal course of business with third-party contract organizations for preclinical trials, non-clinical trials and testing, and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice.

Cash flows

Comparisons of the three months ended March 31, 2026 and 2025

The following table sets forth the primary sources and uses of cash, cash equivalents, and restricted cash for the periods presented below:


	Three Months Ended March 31,
	2026			2025			Change
	(in thousands)
Net cash used in operating activities	$	(39,113	)	$	(29,516	)	$	(9,597	)
Net cash provided by (used in) investing activities		6,275			(299	)		6,574
Net cash provided by financing activities		42,357			127,378			(85,021	)
Net increase in cash, cash equivalents and restricted cash	$	9,519		$	97,563		$	(88,044	)

Net cash used in operating activities

Net cash used in operating activities was $39.1 million and $29.5 million for the three months ended March 31, 2026 and 2025, respectively. The net cash used in operating activities for the three months ended March 31, 2026 was primarily due to our net loss of $24.2 million combined with a net change in our operating assets and liabilities of $23.7 million, offset by $8.8 million in non-cash charges such as depreciation, stock-based compensation, lease expense and amortization of debt discount and debt issuance costs. The net cash used in operating activities for the three months ended March 31, 2025 was primarily due to our net loss of $32.8 million, combined with a net change in our operating assets and liabilities of $1.4 million, offset by $4.7 million in non-cash charges such as depreciation, stock-based compensation and lease expense.

Net cash provided by (used in) investing activities

Net cash provided by investing activities was $6.3 million for the three months ended March 31, 2026, which consisted of maturities of marketable securities of $30.0 million, offset by purchases of marketable securities of $23.6 million and purchases of property and equipment of $0.1 million. Net cash used in investing activities for the three months ended March 31, 2025 was $0.3 million, which consisted of purchases of property and equipment.

Net cash provided by financing activities

Net cash provided by financing activities for the three months ended March 31, 2026 was $42.4 million, which consisted of net proceeds of $38.5 million from the Hercules Loan Agreement and $4.1 million from the exercise of stock option awards, partially offset by the payment of $0.2 million for deferred offering costs related to the Underwritten Registered Offering completed in April 2026. For the three months ended March 31, 2025, net cash provided by financing activities was $127.4 million, which consisted of net proceeds of $127.8 million from the issuance of common stock pursuant to our initial public offering and $0.1 million from the exercise of stock option awards, offset by the payment of $0.5 million for the success fee under the loan and security agreement with Banc of California.

Critical accounting policies, significant judgments and use of estimates

Our significant accounting policies are described in detail in the notes to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q. We described the accounting policies that we believe involve a significant level of estimation and uncertainty, which could have a material impact on our financial condition or results of operations and are therefore deemed critical accounting policies, in our “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, 2025, as filed with the SEC on March, 25, 2026. There have been no significant changes in our critical accounting policies and estimates during the three months ended March 31, 2026.

Our condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The preparation of these condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the condensed financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Emerging growth company status

We are an emerging growth company, or EGC. The Jumpstart Our Business Startups Act of 2012, or the JOBS Act permits companies with EGC status to take advantage of an extended transition period to comply with new or revised accounting standards, delaying the adoption of these accounting standards until they would apply to private companies. We have elected to use this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an EGC or (ii) 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 standards as of public company effective dates.

In addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, if, as an EGC, we intend to rely on such exemptions, we are not required to, among other things:(i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended; (ii) provide all of the compensation disclosure that may be required of non-EGCs under the Dodd-Frank Wall Street Reform and Consumer Protection Act; (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis); and (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the chief executive officer’s compensation to median employee compensation.

We will remain an EGC under the JOBS Act until the earliest of (i) the last date of our fiscal year in which we have total annual gross revenue of at least $1.235 billion, (ii) the date we qualify as a “large accelerated filer,” as defined under Rule 12b-2 of the Exchange Act, (iii) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three years, or (iv) the last day of our first fiscal year following the fifth anniversary of the closing of our initial public offering.

Recent accounting pronouncements

See Note 2, Summary of significant accounting policies, to our unaudited condensed financial statements included in Part 1, Item 1, “Financial Statements (Unaudited),” of this Quarterly Report on Form 10-Q for a description of recent accounting pronouncements applicable to our business.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are exposed to market risks that may result from changes in interest rates and foreign currency exchange rates.

Interest Rate Risk

Investments in marketable securities

As of March 31, 2026 and December 31, 2025, we had cash, cash equivalents and marketable securities of $362.9 million and $360.0 million, respectively. This consisted of interest-bearing money market accounts and investments in U.S. government securities, commercial paper, and corporate debt securities, which create an exposure to interest rate risk. Our future interest income may fall short of expectations due to changes in market conditions and in interest rates and such changes in interest rates may affect the fair value of the marketable securities held in our portfolio and cause unrealized gains or losses. Such gains or losses would not be realized unless the investments are sold. A hypothetical one percent increase in interest rates as of March 31, 2026 and December 31, 2025 would not have resulted in a material effect on the fair market value of our cash, cash equivalents and marketable securities.

Long-term debt

As of March 31, 2026 we had an outstanding term loan with a carrying value of $38.8 million bearing interest at a rate equal to the greater of (i) 7.95% or (ii) the prime rate plus 0.95%. A hypothetical one percent increase in the prime rates as of March 31, 2026 would not have resulted in a material effect on the fair market value of our debt. In addition, a hypothetical one percent increase in the prime rates as of March 31, 2026 would not result in a material impact to our income for the year ending December 31, 2026. We did not have any outstanding debt as of December 31, 2025.

Foreign Currency Exchange Risk

The majority of our transactions occur in U.S. dollars. However, we do have certain transactions that are denominated in currencies other than the U.S. dollar, primarily the euro and British pound, and we therefore are subject to foreign exchange risk. The fluctuation in the value of the U.S. dollar against other currencies affects the reported amounts of expenses, assets and liabilities primarily associated with a limited number of preclinical, clinical and manufacturing activities. We do not hedge our foreign currency exchange rate risk, however, we may do so in the future. As of March 31, 2026 and December 31, 2025, we had no material accounts payable or receivable denominated in foreign currencies, and a hypothetical 10% change in foreign currency exchange rates applicable to our business would not have a material impact on our condensed financial statements.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

As of March 31, 2026, our management, including our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in U.S. Securities and Exchange Commission, or the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosures.

Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of March 31, 2026, the design and operation of our disclosure controls and procedures were effective at a reasonable assurance level.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended March 31, 2026 that has materially affected, or is 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 litigation or other legal proceedings arising in the ordinary course of business. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are probable to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources, negative publicity and reputational harm.

Item 1A. Risk Factors

Risk Factors

Our business faces significant risks and uncertainties, and those described below may not be the only risks and uncertainties we face. We cannot assure you that any of the events discussed below will not occur. You should carefully consider the following risk factors, together with the information contained herein and in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission, or SEC, on March 25, 2026, including our financial statements and the related notes, and our other filings with the SEC, before deciding whether to invest in our common stock. Additional risks and uncertainties not presently known to us or that we currently believe are immaterial may also significantly impair our business, financial condition or results of operations. These disclosures reflect the management’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities in the future. References to past events are provided by way of example only and are not intended to be a complete listing of such events or a representation as to whether or not such factors or similar events have occurred in the past or their likelihood of occurring in the future. If any of these risks or uncertainties occur, our business, financial condition or results of operations could suffer, the market price of our common stock could decline and you could lose all or part of your investment in our common stock.

Risks related to our limited operating history, financial position and need for capital

Investment in drug development is a highly speculative undertaking and involves a substantial degree of risk. We are a clinical-stage biopharmaceutical company with a limited operating history. Our lead programs are still in early clinical development, and we are subject to the risks of failure inherent in the development of therapeutic candidates based on novel technologies. We have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biotechnology industry. Furthermore, we do not expect to generate any product revenue from commercial sales for the foreseeable future, and we expect to continue to incur significant operating losses for the foreseeable future due to the cost of clinical trials, preclinical studies, research and development, and the regulatory approval process of our therapeutic candidates. For the three months ended March 31, 2026 and 2025, we incurred a net loss of $24.2 million and $32.8 million, respectively. As of March 31, 2026, we had an accumulated deficit of $513.8 million. We expect to continue to incur significant research and development and other expenses related to our ongoing operations.

Our prior losses, combined with expected future losses, have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital. We expect our research and development expenses to significantly increase in connection with the ongoing clinical trials for our lead programs, MZE829 and MZE782, further development of our Maze Compass platform, or our Compass platform, planned preclinical studies, IND filings and clinical trials for future therapeutic candidates. We will also incur substantial additional expenses as we seek to expand our intellectual property portfolio, including through potential in-licensing opportunities, and hire additional personnel as we scale up our operations. We expect to continue to incur additional costs associated with operating as a public company. As a result, we expect to continue to incur significant and increasing operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if at all.

Our ability to become profitable depends upon our ability to generate revenue. To date, we have not generated any revenue apart from upfront licensing payments, and we do not know when, or if, we will generate any sales, milestone, or royalty revenue. We do not expect to generate additional significant revenue from licensing arrangements in the near term. We do not expect to generate significant revenue unless and until we obtain marketing approval for, and begin to sell, our therapeutic candidates.

To become and remain profitable, we must succeed in designing, developing and eventually commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including therapeutic candidate selection, preclinical testing and clinical trials of our therapeutic candidates, continuing to discover and develop additional therapeutic candidates, establishing arrangements with third parties for the manufacture of preclinical and clinical supplies, obtaining regulatory approval for any therapeutic candidates that successfully complete clinical trials, manufacturing, marketing and selling any products for which we may obtain marketing approval and obtaining coverage and adequate reimbursement from government and third-party payors for any such products. We are only in the preliminary stages of development and clinical trials, and we may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability or meet outside expectations for our profitability.

Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to accurately predict the timing or amount of increased expenses we will incur or when, or if, we will be able to achieve profitability. If we decide to or are required by the U.S. Food and Drug Administration, or FDA, or regulatory authorities in other jurisdictions to perform preclinical studies or clinical trials in addition to those currently expected, or if there are any delays in establishing appropriate manufacturing arrangements for, in initiating clinical trials or preclinical studies for, or in the development of any of our therapeutic candidates, our expenses could increase materially and profitability could be further delayed.

Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. We expect our financial condition and operating results to fluctuate significantly from quarter-to-quarter and year-to-year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of future operating performance. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

Developing pharmaceutical products, including conducting clinical trials and preclinical studies, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase substantially in connection with our ongoing research and development activities, particularly as we advance our developmental programs, advance our current clinical trial and preclinical studies, commence additional clinical trials and preclinical studies and expand the breadth of our Compass platform. In addition, even if we obtain marketing approval for any of our therapeutic candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We expect to continue to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional capital in connection with our continuing operations. Adequate additional financing may not be available to us on favorable terms, or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. If we are unable to raise capital when needed or on favorable terms, we could be forced to delay, reduce or eliminate our clinical and preclinical development, research and development programs, our commercialization plans or other operations.

As of March 31, 2026, our cash, cash equivalents and marketable securities were $362.9 million. Based on our current operating plan, we believe our existing cash, cash equivalents and marketable securities as of March 31, 2026 will enable us to fund our operating expenses and capital expenditure requirements for at least one year from the date of this Quarterly Report on Form 10-Q. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Changes beyond our control may occur that would cause us to use our available capital before that time, including changes in and progress of our development activities and changes in regulation. Our future capital requirements will depend on many factors, including, but not limited to:

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the extent to which we develop, in-license or acquire other pipeline therapeutic candidates or technologies;

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the number and development requirements of other therapeutic candidates that we may pursue, and other indications for our current therapeutic candidates that we may pursue;

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the costs related to entering into partnerships or other arrangements with third parties;

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the costs, timing and outcome of obtaining regulatory approvals of our current or future therapeutic candidates we may pursue;

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the costs and fees associated with the discovery, acquisition or in-license of our products or technologies, including to maintain and expand our Compass platform;

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the scope and costs of making arrangements with third-party manufacturers for preclinical, clinical and commercial supplies of our current or future therapeutic candidates;

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the scope and costs involved in growing our organization to the size needed to allow for the research, development and potential commercialization of our current or future therapeutic candidates;

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the costs associated with commercializing any approved therapeutic candidates, including establishing sales, marketing and distribution capabilities;

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the costs associated with completing any post-marketing studies or trials required by the FDA or other regulatory authorities;

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the revenue, if any, received from commercial sales of our current or future therapeutic candidates, if any are approved;

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the costs associated with addressing any potential interruptions or delays resulting from factors related to overall global affairs, such as conflicts overseas;

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the costs associated with potential product liability claims, including the costs associated with obtaining insurance against such claims and with defending against such claims; and

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We will require additional capital for our research and development programs. Our ability to raise additional funds will be dependent on financial, economic and market conditions, geopolitical issues and other factors, over which we may have limited or no control. If adequate funds are not available on commercially acceptable terms when needed, we may be forced to delay, reduce or terminate our research and development activities of all or part of our research programs or therapeutic candidates or we may be unable to take advantage of future business opportunities. Furthermore, any additional capital-raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our current and future therapeutic candidates, if approved. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.

Raising additional capital may cause dilution to our stockholders, cause the price of our common stock to decline, restrict our operations or require us to relinquish rights to our technologies or therapeutic candidates.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans.

We have an effective Form S-3ASR automatic shelf registration statement, or the “Shelf Registration,” on file with the Securities and Exchange Commission, or SEC, which allows us to sell any combination of common stock, preferred stock, debt securities, warrants, subscription rights, and/or units consisting of one or more of the foregoing in one or more offerings.

We have also entered into an Open Market Sale Agreement with Jefferies LLC, serving as our sales agent, with respect to an at-the-market offering program pursuant to which we may elect to issue and sell shares of our common stock having an aggregate offering price of up to $200.0 million, or the 2026 Sale Agreement, in such quantities and on such minimum price terms as we set from time to time through our sales agent. To date, no sales have occurred under the 2026 Sale Agreement.

The issuance of additional shares of our common stock pursuant to the Shelf Registration or the 2026 Sale Agreement, or issuances of securities convertible into or exercisable for our common stock or other equity-linked securities, including preferred stock, warrants, debt securities or units, would dilute the ownership interest of our existing stockholders. Further, any such sales, or the anticipation of such sales, could depress the market price of our common stock and impair our ability to raise capital through the sale of additional securities. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or therapeutic candidates, including granting licenses to our technologies, on terms that may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to third parties to develop and market therapeutic candidates that we would otherwise prefer to develop and market ourselves.

Our loan and security agreement provides our lender with a first priority lien against substantially all of our assets, except for intellectual property, and contains restrictive and financial covenants that may limit our operating flexibility.

On February 4, 2026, we entered into a loan and security agreement, or the Hercules Loan Agreement, with certain lenders and Hercules Capital, Inc., in its capacity as administrative agent and collateral agent for itself and the lenders party thereto, which provides for a senior secured term loan facility, or the Hercules Term Loan Facility, in an aggregate principal amount of up to $200.0 million. An initial term loan of $40.0 million was funded under the Hercules Loan Agreement and the Hercules Term Loan Facility includes up to six additional term loan tranches providing up to an aggregate $160.0 million in additional loan commitments through February 2031, so long as we satisfy certain conditions precedent. The final tranche of $50.0 million is subject to approval by the lenders’ investment committee. The facility has a maturity date of February 1, 2031, and may be prepaid at any time, subject to prepayment premiums. This senior secured term facility will accrue interest at an annual rate determined by reference to the Prime Rate as reported in the Wall Street Journal, with interest rate floors that range from 7.95% to 9.25% depending on the tranche. Accrued interest is payable on the first business day of each month until (a) February 2030 or (b) if certain performance and financing milestones are satisfied, the maturity date. The Federal Reserve has raised, and may in the future further raise, interest rates to combat the effects of recent high inflation. An increase in the prime rate resulting in interest rates above the set minimum rate would increase our debt service obligations, which could have a negative impact on our cash flow, financial position or operating results, or result in increased borrowing costs in the future.

All of our obligations under the Hercules Loan Agreement are secured by a first lien perfected security interest on substantially all of our existing assets and after-acquired assets, except for intellectual property, subject to customary exceptions.

The Hercules Loan Agreement contains certain representations and warranties, affirmative covenants, negative covenants, financial covenants, and conditions that are customarily required for similar financings. The affirmative covenants, among other things, require us to undertake various reporting and notice requirements and an obligation to maintain in force certain rights, approvals and assets. The negative covenants restrict or limit our ability to, among other things and subject to certain exceptions contained in the Hercules Loan Agreement, incur new indebtedness, create liens on assets, engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s business activities, and to make Investments (as defined in the Hercules Loan Agreement) or distributions, or redemptions, in each case subject to customary exceptions. The negative covenants also restrict our ability to change our fiscal year, repay certain other indebtedness, engage in certain affiliate transactions, or enter into, amend or terminate any other agreement that has the impact of restricting our ability to make loan repayments under the Hercules Loan Agreement. In addition, unless either (i) our market capitalization is greater than or equal to $450.0 million and an aggregate of no more than $85.0 million in principal amount is outstanding under the term loans or (ii) our market capitalization is greater than or

equal to $750.0 million, we must at all other times maintain unrestricted cash and cash equivalents of at least 50% of the outstanding loan amount, decreasing to 40% and 35% upon satisfaction of certain performance and financing milestones. Our ability to comply with these covenants and restrictions may be affected by events beyond our control, and breaches of these covenants and restrictions could result in a default under the Hercules Loan Agreement or under any future financing agreements that we may enter into, which would give our lenders the right to terminate their commitments to provide loans and to declare all borrowings outstanding, together with accrued and unpaid interest and fees, to be immediately due and payable. Conforming to such restrictive and financial covenants under the Hercules Loan Agreement may limit our operating flexibility and we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to third parties to develop and market therapeutic candidates that we would otherwise prefer to develop and market ourselves.

The Hercules Loan Agreement also contains certain customary Events of Default (as defined in the Hercules Loan Agreement). The occurrence of an Event of Default could result in, among other things, the declaration that all outstanding principal and interest under the Hercules Term Loan Facility are immediately due and payable in whole or in part. See Note 10, Loan and security agreement, in Part I, Item 1 of this Quarterly Report on Form 10-Q for further discussion of the Hercules Loan Agreement.

Risks related to discovery and development of our therapeutic candidates

Our therapeutic candidates are in early stages of development. We do not have any products that are approved for sale in any jurisdiction. We initiated a Phase 2 trial of MZE829, our most advanced lead program, in November 2024, dosed our first patient in February 2025 and reported positive topline clinical proof of concept data in March 2026. We initiated a Phase 1 clinical trial of our second lead program, MZE782, in September 2024 and announced initial clinical data in phenylketonuria, or PKU, and chronic kidney disease, or CKD, in September 2025. We plan to initiate two Phase 2 trials of MZE782 in PKU and CKD in 2026. Our other programs are at an early research stage, with no therapeutic candidates identified. Our research programs may not result in viable therapeutic candidates for some time, if ever, and our therapeutic candidates in development may not achieve success in our current or any future clinical trials, or obtain regulatory approval.

Our ability to generate product revenues, which may not occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our therapeutic candidates. The success of our therapeutic candidates will depend on several factors, including, but not limited to:

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timely and successful completion of, and timely enrollment of patients in, clinical trials with favorable results;

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submission of new drug applications, or NDAs, or other regulatory applications, and receipt and related terms of regulatory approvals from applicable regulatory authorities, including the completion of any required post-marketing studies or trials and available funding to perform any post-marketing commitments;

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raising additional funds necessary to complete clinical development of and commercialize our therapeutic candidates;

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timely and successful completion of preclinical studies with favorable results;

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submission of INDs or other regulatory applications, and authorizations to initiate clinical trials from the FDA and foreign regulatory agencies;

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demonstration of safety, efficacy and acceptable risk-benefit profiles of our therapeutic candidates to the satisfaction of the FDA and foreign regulatory authorities;

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obtaining, maintaining, defending and enforcing patent, trade secret and other intellectual property and proprietary protection and regulatory exclusivity for our therapeutic candidates;

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making arrangements with third-party suppliers and manufacturers for preclinical, clinical and commercial supplies of our therapeutic candidates;

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developing and implementing marketing and reimbursement strategies, as well as adequate demand forecasts for supply and sales planning;

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establishing sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone or in collaboration with others in a market where promotional sales approaches are rapidly moving to digital platforms;

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acceptance of our products, if and when approved, by patients, the medical community and third-party payors;

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effectively competing with other therapies, including those that have not yet entered the market;

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obtaining and maintaining third-party payor coverage and adequate reimbursement;

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obtaining appropriate support from patient advocacy organizations;

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addressing any delays in our clinical trials, or in the manufacture or distribution of our therapeutic candidates, if approved, resulting from any major natural disasters, health pandemics, economic conditions or significant political events; and

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maintaining a continued acceptable safety profile of the products following approval.

Many of these factors are beyond our control, and it is possible that none of our therapeutic candidates will ever obtain regulatory approval, even if we expend substantial time and resources seeking such approval. Even if we do obtain regulatory approval, it is possible that one or more of these factors could cause significant delays or an inability to successfully commercialize our therapeutic candidates, which would materially harm our business.

Additionally, clinical or regulatory setbacks to other companies developing similar products or within adjacent fields, may impact the clinical development of and regulatory pathway for our current or future therapeutic candidates, or may negatively impact the perceptions of value or risk of our technologies.

We have limited experience designing and implementing clinical trials. We initiated a Phase 2 trial of MZE829, our most advanced lead program, in November 2024, dosed our first patient in February 2025 and reported positive topline clinical proof of concept data in March 2026. We initiated a Phase 1 clinical trial of MZE782 in September 2024 and announced initial clinical data in PKU and CKD in September 2025. We plan to initiate two Phase 2 trials of MZE782 in patients with PKU and in patients with CKD in 2026. Failure to design any one of our clinical trials adequately, or incorrect assumptions about the design of the trial, could adversely affect the ability to initiate the trial, enroll patients, complete the trial, or use the clinical trial’s results to support an application for regulatory approval, as well as lead to increased or unexpected costs.

Our programs are in the early stages of development, and the risk of failure is high. Our programs may fail to identify potential therapeutic candidates for clinical development for a number of reasons. We are unable to predict when or if our programs will lead to therapeutic candidates or when or if our therapeutic candidates will prove effective and safe in humans or will obtain marketing approval. Before obtaining marketing approval from regulatory authorities for the sale of any of our therapeutic candidates, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our therapeutic candidates in humans. Our potential therapeutic candidates may be shown to have harmful side effects in animal model studies, may not show promising signals of therapeutic effect in such experiments or studies, or may have other characteristics that may make the therapeutic candidates impractical to manufacture, unmarketable, or unlikely to receive marketing approval.

We are currently focused on advancing the development of our lead programs, MZE829 and MZE782; however, even with significant investment of time and funding to advance these therapeutic candidates, we cannot guarantee that our clinical and preclinical development efforts will be successful. The start or end of a clinical trial may be delayed or halted due to delays in or failure to obtain regulatory approval to commence the trial, delays in or failure to reach agreement on acceptable terms with prospective clinical research organizations, or CROs, or clinical trial sites, delays in or failure to obtain Institutional Review Board, or IRB, approval at each site, changing regulatory requirements, manufacturing challenges, clinical sites or CROs deviating from the trial protocol or failing to comply with regulatory requirements or meet contractual obligations, slower than anticipated patient enrollment, changing standards of care, availability or prevalence of use of a comparative therapeutic or required prior therapy, clinical outcomes, failure of patients to complete the trial or return for post-treatment follow-up, or financial constraints. Delays or difficulties in patient enrollment or difficulties in retaining trial participants can result in increased costs, longer development times, requirements to manufacture additional drug supply, or termination of a clinical trial.

Clinical trials of a new therapeutic candidate require the enrollment of a sufficient number of patients, which may include patients who are suffering from the disease the therapeutic candidate is intended to treat and who meet other eligibility criteria, which may require genetic testing of prospective patients. Rates of patient enrollment are affected by many factors, including the size of the patient population, the eligibility criteria for the clinical trial, the age and condition of the patients, the stage and severity of disease, the nature of the protocol, the proximity of patients to clinical sites, and the availability of effective treatments or competing academic and other sponsored clinical trials for the relevant disease.

A therapeutic candidate can unexpectedly fail at any stage of preclinical and clinical development. The historical failure rate for therapeutic candidates is high due to scientific feasibility, safety, efficacy, changing standards of medical care, and other variables. Although our Compass platform was designed to increase the probability of developing new medicines, it may still result in high failure rates equivalent to historical norms. We will have to conduct additional trials in our proposed indications to support any future regulatory submissions. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles despite promising results in earlier, smaller clinical trials. Moreover, clinical data are often susceptible to varying interpretations and analyses. We do not know whether our clinical trials will demonstrate consistent or adequate efficacy and safety with respect to the proposed indication for use that is sufficient to receive regulatory approval or market our therapeutic candidates. To the extent that the results of the clinical trials are not satisfactory to the FDA or foreign regulatory agencies for supporting a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional clinical trials in support of potential approval of our therapeutic candidates.

We, the FDA, an IRB, an independent ethics committee, or EC, or other applicable regulatory authorities may suspend clinical trials of a therapeutic candidate at any time for various reasons, including a belief that subjects participating in such trials are being exposed to unacceptable health risks or adverse side effects. Similarly, an IRB or EC may suspend a clinical trial at a particular trial site. We may not have the financial resources to continue development of, or to enter into collaborations for, a therapeutic candidate if we experience any problems or other unforeseen events delaying or preventing clinical development or regulatory approval of, or our ability to commercialize, therapeutic candidates, including:

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Maze Therapeutics, Inc. 10-Q