What changed in this filing

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Item 1. Financial Statements

2026-05-12 compared with 2025-11-06 · 263 added, 299 removed, 255 unchanged (69% of the section changed)

3 unchanged sentences

(in thousands, except share and per share data)

September 30,

Current assets:

Cash and cash equivalents

Marketable securities

Marketable securities, current

Accounts receivable

Prepaid expenses and other current assets

2 unchanged sentences

Restricted cash

Marketable securities, non-current

Operating lease right-of-use asset

Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

Liabilities and Stockholders’ Equity

Current liabilities:

4 unchanged sentences

Operating lease liabilities, net of current portion

Term loan, non-current

Other liabilities, non-current

1 unchanged sentence

Commitments and contingencies (Note 9)

Redeemable convertible preferred stock, $ 0.001 par value;

no shares authorized,

issued and outstanding as of September 30, 2025;

298,205,027 shares authorized

and 297,205,041 shares issued and outstanding as of December 31, 2024;

aggregate liquidation preference of $ 502,390 as of December 31, 2024

Stockholders’ equity (deficit):

Stockholders’ equity:

Preferred stock, $ 0.001 par value;

10,000,000 and no shares authorized as

of September 30, 2025 and December 31, 2024, respectively;

no shares issued

and outstanding as of September 30, 2025 and December 31, 2024

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 and 410,000,000 shares authorized as

of September 30, 2025 and December 31, 2024, respectively;

500,000,000 shares authorized as of

March 31, 2026 and December 31, 2025;

49,737,619 and 49,335,551

2,446,864 shares issued and outstanding as of September 30, 2025 and

December 31, 2024, respectively;

10,372 shares subject to repurchase as of

September 30, 2025 and December 31, 2024

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

Additional paid-in-capital

Accumulated other comprehensive income

Accumulated other comprehensive (loss) income

Accumulated deficit

Total stockholders’ equity (deficit)

Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)

Total stockholders’ equity

Total liabilities and stockholders’ equity

See accompanying notes to these financial statements.

Maze Therapeutics, Inc.

Condensed Statements of Opera tions and Comprehensive (Loss) Income

Condensed Statements of Opera tions and Comprehensive Loss

(in thousands, except share and per share data)

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

License revenue

3 unchanged sentences

Total operating expenses

(Loss) income from operations

Loss from operations

Other income (expense):

Interest and other income, net

Change in fair value of convertible promissory notes

(Loss) income before income tax benefit (expense)

Income tax benefit (expense)

Net (loss) income

Allocation of undistributed earnings to participating securities (see Note 13)

Net (loss) income attributable to common stockholders, basic (see Note 13)

Net (loss) income attributable to common stockholders, diluted (see Note 13)

Net (loss) income per share attributable to common stockholders (see Note 13):

Weighted-average shares of common stock outstanding used to compute net (loss) income per share attributable to common stockholders (see Note 13):

Comprehensive income:

Net (loss) income

Other comprehensive income:

Net unrealized gain on marketable securities

Comprehensive (loss) income

Interest expense

Total other income, net

Net loss per share, basic and diluted (see Note 12):

Weighted-average shares of common stock outstanding used to compute net loss per share, basic and diluted (see Note 12):

Comprehensive loss:

Other comprehensive loss:

Net unrealized loss on marketable securities

Comprehensive loss

See accompanying notes to these financial statements.

6 unchanged sentences

stockholders’

income (loss)

equity (deficit)

Balance as of December 31, 2024

Issuance of common stock in connection with initial public offering, net of issuance costs of $ 15,402

Conversion of redeemable convertible preferred stock to common stock upon initial public offering

( 297,205,041

Exercise of stock options

Issuance of restricted stock

Vesting of restricted stock and early exercised

stock options

Stock-based compensation expense

Net loss and comprehensive loss

Balance as of March 31, 2025

Exercise of stock options

Issuance of restricted stock

Vesting of restricted stock and early exercised

stock options

Stock-based compensation expense

Net income and comprehensive income

Balance as of June 30, 2024

Exercise of stock options

Issuance of restricted stock

Repurchase of early exercised stock options

Vesting of restricted stock and early exercised

stock options

Stock-based compensation expense

Net income and comprehensive income

Balance as of September 30, 2024

Redeemable convertible

2 unchanged sentences

stockholders’

equity (deficit)

income (loss)

Balance as of December 31, 2025

Issuance of common stock in connection with initial public offering, net of issuance costs of $ 15,402

Conversion of redeemable convertible preferred stock to common stock upon initial public offering

( 297,205,041

Exercise of stock options

Issuance of common stock upon vesting of restricted stock awards

Stock-based compensation expense

Net loss and comprehensive loss

Net unrealized loss on marketable securities

Balance as of March 31, 2026

Issuance of restricted stock

Issuance of common stock under the 2025 Employee Stock Purchase Plan

Stock-based compensation expense

Net loss and comprehensive loss

Balance as of June 30, 2025

Issuance of common stock and pre-funded warrants to purchase common stock in connection with private placement, net of issuance costs of $ 8,657

Exercise of stock options

Stock-based compensation expense

Net unrealized gain on marketable securities

Balance as of September 30, 2025

See accompanying notes to these financial statements.

2 unchanged sentences

(in thousands)

Nine Months Ended September 30,

Three Months Ended March 31,

Operating activities

Net (loss) income

Adjustments to reconcile net (loss) income to net cash (used in) provided by operating

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

Depreciation expense

Stock-based compensation expense

Non-cash lease expense

Accretion of discounts on marketable securities

Change in fair value of convertible promissory notes

Accretion of discounts on marketable securities, net

Amortization of debt discount and debt issuance costs

Other items, net

Changes in operating assets and liabilities:

Accounts receivable

Prepaid expenses and other current assets

2 unchanged sentences

Operating lease liabilities

Net cash (used in) provided by operating activities

Long-term liabilities

Net cash used in operating activities

Investing activities

Purchases of marketable securities

Maturities of marketable securities

Purchases of property and equipment

Net cash used in investing activities

Net cash provided by (used) in investing activities

Financing activities

Proceeds from initial public offering, net of offering costs paid

Proceeds from private placement, net of offering costs paid

Proceeds from exercise of stock option awards, net of repurchases

Proceeds from issuance of common stock under the 2025 Employee Stock Purchase Plan

Proceeds from issuance of convertible promissory notes, net of issuance costs

Proceeds from debt issuance, net

Payment of debt issuance costs

Proceeds from exercise of stock option awards

Payment of deferred offering costs

Payment of offering costs for private placement

Proceeds from initial public offering, net of offering costs paid

Payment of success fee derivative

5 unchanged sentences

Purchases of property and equipment recorded in accounts payable and accrued expenses

Vesting of restricted stock and stock options subject to repurchase

Offering costs recorded in accounts payable and accrued expenses

Debt issuance costs recorded in accounts payable and accrued expenses

Deferred offering costs recorded in accrued expenses

Reconciliation to cash, cash equivalents and restricted cash:

2 unchanged sentences

Total cash, cash equivalents and restricted cash

Supplemental disclosure of cash flow information:

Income taxes paid

See accompanying notes to these financial statements.

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Description of business

Maze Therapeutics, Inc., or the Company, is a clinical-stage biopharmaceutical company harnessing the power of human genetics and variant functionalization with its Maze Compass platform to develop novel, small molecule precision medicines for patients living with kidney and metabolic diseases, including obesity.

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.

Reverse stock split

On January 22, 2025, the Company’s board of directors approved a 1-for-9.641 reverse stock split of its issued and outstanding shares of common stock, which was effected on January 24, 2025.

Upon the effectiveness of the reverse stock split, (i) all shares of outstanding common stock were adjusted;

(ii) the conversion ratio of the convertible preferred stock was adjusted;

(iii) the number of shares of common stock for which each outstanding option to purchase common stock is exercisable were adjusted;

and (iv) the exercise price of each outstanding option to purchase common stock was adjusted.

All of the outstanding common stock share numbers (including shares of common stock subject to the Company’s options and as converted for the outstanding convertible preferred stock), share prices, exercise prices and per share amounts contained in the condensed financial statements have been retroactively adjusted in the condensed financial statements to reflect this reverse stock split for all periods presented.

The par value per share and the authorized number of shares of common stock and preferred stock were not adjusted as a result of the reverse stock split.

Initial public offering

In February 2025, the Company completed its initial public offering, pursuant to which it issued and sold an aggregate of 8,750,000 shares of its common stock at an initial public offering price of $ 16.00 per share, resulting in net proceeds of approximately $ 127.8 million, after deducting underwriting discounts, commissions and other offering expenses paid by the Company in 2025.

Immediately prior to the closing of the initial public offering, the Company’s outstanding convertible preferred stock automatically converted into 32,586,823 shares of common stock.

Following the closing of the initial public offering, no shares of convertible preferred stock were authorized or outstanding.

In connection with the completion of the initial public offering on February 3, 2025, the Company’s certificate of incorporation was amended and restated to (i) authorize 500,000,000 shares of common stock, par value $ 0.001 per share and (ii) authorize 10,000,000 shares of undesignated preferred stock, par value $ 0.001 per share, each of which may be issued from time to time by the Company’s board of directors in one or more series.

The amended and restated certificate of incorporation eliminated all references to the previously existing series of convertible preferred stock.

Private placement

On September 10, 2025, the Company entered into a securities purchase agreement with certain investors, pursuant to which the Company issued and sold in a private placement, or the Private Placement, an aggregate of 4,000,002 shares of its common stock at a purchase price of $ 16.25 per share and 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 Pre-Funded Warrants, resulting in net proceeds of approximately $ 141.3 million, after deducting placement fees and other offering expenses payable by the Company of approximately $ 8.7 million.

Each Pre-Funded Warrant has an exercise price of $ 0.001 per share, is immediately exercisable and does not expire.

As of September 30, 2025 , no ne of the Pre-Funded Warrants have been exercised.

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 since its inception, except for the net income and cash provided by operations during the year ended December 31, 2024, and expects to incur significant and increasing losses as a result of its continued research and development activities.

As of September 30, 2025, the Company had an accumulated deficit of $ 455.0 million .

Historically, the Company has financed its operations primarily through issuances of its equity, issuances of convertible promissory notes and license agreements.

The Company may seek to raise capital through debt financings, equity financings, license agreements, or other sources of financing.

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 September 30, 2025, the Company had cash, cash equivalents and marketable securities of $ 383.9 million .

The Company believes that its cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to fund the Company’s operations for at least one year from the issuance date of these unaudited condensed financial statements.

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

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These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period.

During the nine months ended September 30, 2025, there were no significant changes to the Company’s significant accounting policies as described in the Company’s audited financial statements as of and for the year ended December 31, 2024 , as included in the 2024 10-K.

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 U.S.

GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes.

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 expenses reported are affected by estimates and assumptions, which are used for, but are not limited to, measuring and recognizing revenue, and determining the fair value of assets and liabilities, including the Company’ s convertible promissory notes, common stock valuation, income tax uncertainties, measurement of stock-based compensation expense, and certain accruals.

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.

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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) income from operations which is reported on the condensed statements of operations and comprehensive (loss) income as total (loss) income from operations.

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 September 30, 2025 and December 31, 2024 , all of the Company’s property and equipment was maintained in the United States.

No revenue was generated during the three and nine months ended September 30, 2025 .

The Company generated revenue of $ 2.5 million and $ 167.5 million during the three and nine months ended September 30, 2024 , respectively.

The following table presents selected financial information with respect to the Company’s single operating segment for the three and nine months ended September 30, 2025 and 2024 (amounts in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

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,

License revenue

8 unchanged sentences

Segment operating expenses

Segment (loss) income from operations

Segment interest and other income, net

Change in fair value of convertible promissory notes

Segment (loss) income before income taxes

Segment loss from operations

Segment other income, net

Fair value measurement

8 unchanged sentences

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 September 30, 2025 and December 31, 2024 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 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 September 30, 2025 and December 31, 2024 , restricted cash consisted of money market funds.

Marketable securities

The Company generally invests its excess cash in money market funds and investment grade short- to intermediate-term fixed income securities.

Such investments are included in cash and cash equivalents, short-term marketable securities or long-term marketable securities on the condensed balance sheets, are considered available-for-sale, and are reported at fair value with net unrealized gains and losses included as a component of stockholders’ equity.

The Company classifies investments in securities with original maturities over 90 days and remaining maturities of less than one year as short-term investments and investments in securities with remaining maturities of over one year as long-term investments.

The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest and other income, net in the condensed statements of operations and comprehensive (loss) income.

Realized gains and losses and declines in value determined to be due to credit losses on marketable securities, if any, are included in interest and other income, net.

The Company periodically evaluates the need for an allowance for credit losses.

This evaluation includes consideration of several qualitative and quantitative factors, including whether it has plans to sell the security, whether it is more likely than not it will be required to sell any marketable securities before recovery of its amortized cost basis, whether it has the ability and intent to hold the security to maturity and the portion of any unrealized loss that is the result of a credit loss.

Factors considered in making these evaluations include quoted market prices, recent financial results and operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, expected cash flows from securities, other publicly available information that may affect the value of the marketable security, duration and severity of the decline in value and the Company's strategy and intentions for holding the marketable security.

The Company excludes the applicable accrued interest from both the fair value and amortized cost basis of marketable securities for purposes of identifying and measuring an impairment.

Accrued interest receivable on marketable securities is recorded within prepaid expenses and other current assets on the condensed balance sheets.

The Company’s accounting policy is to not measure an allowance for credit loss for accrued interest receivable and to write-off any uncollectible accrued interest receivable as a reversal of interest income in a timely manner, which is considered to be in the period in which it is determined the accrued interest will not be collected.

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 (deficit) 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) income.

As of December 31, 2024 , approximately $ 4.3 million of deferred offering costs related to the Company’s initial public offering were recorded within other assets in the accompanying condensed balance sheets and upon completion of the Company’s initial public offering in February 2025, the deferred offering costs were recorded as a reduction to the additional paid-in capital within stockholders’ equity (deficit) recorded in the accompanying condensed balance sheets as of September 30, 2025 .

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

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Non-refundable upfront payments are considered fixed consideration and included in the transaction price.

If an arrangement includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method.

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.

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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.

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If the Company expects to have an unconditional right to receive consideration in the next twelve months, this will be classified in current assets.

Convertible promissory notes

From December 2023 through April 2024, the Company issued a total of $ 40.7 million aggregate principal amount of convertible promissory notes, which contained automatic conversion features triggered upon a qualified preferred stock financing or a qualified public offering.

As permitted under Accounting Standards Codification 825, Financial Instruments , or ASC 825, the Company elected the fair value option for recognition of the convertible promissory notes.

In accordance with ASC 825, the Company recorded these convertible promissory notes at fair value and remeasured the convertible promissory notes at fair value each reporting period with changes in fair value recorded in the condensed statements of operations and comprehensive (loss) income.

As a result of applying the fair value option, direct costs and fees related to the convertible promissory notes were recognized in earnings as incurred and not deferred.

The impact of interest expense on the convertible promissory notes is included within the changes in fair value.

The Company recorded a loss of $ 2.6 million and $ 7.2 million in the condensed statements of operations and comprehensive (loss) income for the three and nine months ended September 30, 2024 , respectively, reflecting the change in the fair value of the convertible promissory notes.

In connection with the private placement of Series D convertible preferred stock the Company completed in November 2024, which was a qualified preferred stock financing pursuant to the terms of the convertible promissory notes, the outstanding convertible promissory notes automatically converted into shares of Series D-1 convertible preferred stock, and no convertible promissory notes were outstanding as of December 31, 2024.

Accordingly, no change in fair value of convertible promissory notes was recorded in the condensed statements of operations and comprehensive (loss) income for the three and nine months ended September 30, 2025 .

Redeemable convertible preferred stock

The Company recorded convertible preferred stock at fair value on the dates of issuance, net of issuance costs.

Upon the occurrence of certain events that were outside the Company’s control, including a deemed liquidation event, holders of the convertible preferred stock could cause redemption for cash.

Therefore, redeemable convertible preferred stock was classified outside of stockholders’ equity (deficit) on the balance sheet as events triggering the redemption were not solely within the Company’s control.

The carrying values of the redeemable convertible preferred stock were subject to adjustment to their redemption value if and when it became probable that the preferred stock would become redeemable.

Net income (loss) per share

Net income (loss) per share attributable to common stockholders is calculated using the two-class method required for companies with participating securities.

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 income (loss) per share attributable to common stockholders is computed by dividing net income (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 completed the Private Placement, pursuant to which the Company issued the Pre-Funded Warrants to purchase 5,231,090 shares of its 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.

As of September 30, 2025, none of the Pre-Funded Warrants have been exercised.

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 income (loss) per share is computed by dividing net income (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 income (loss) per share, the Company applies the more dilutive of the two-class method or the if-converted method to the redeemable convertible preferred stock, applies the treasury stock method to equity awards, and applies the if-converted method to the convertible promissory notes, if dilutive.

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 and nine months ended September 30, 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.

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 December 2023, Financial Accounting Standards Board, or the FASB, issued ASU 2023-09, Improvements to Income Tax Disclosures , which will require incremental income tax disclosures on an annual basis for all public entities.

The amendments require that public business entities disclose specific categories in the rate reconciliation and provide additional information for reconciling items meeting a quantitative threshold.

The amendments also require disclosure of income taxes paid to be disaggregated by jurisdiction, and disclosure of income tax expense disaggregated by federal, state, and foreign.

ASU 2023-09 is effective for annual reporting beginning with the fiscal year ending December 31, 2025.

The Company is currently evaluating the incremental disclosures that will be required in its financial statements.

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.

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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 is currently evaluating the incremental disclosures that will be required in its financial statements.

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 and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy.

See Note 10, Loan and security agreement, for the Company’s methodology for measuring the fair value of the credit line success fee derivative.

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)

As of September 30, 2025

As of March 31, 2026

Cash equivalents

Money market funds

treasury securities

government agency securities

Marketable securities

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government agency securities

Commercial paper

Corporate debt securities

Restricted cash

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Money market funds

Marketable securities

treasury securities

government agency securities

Commercial paper

Corporate debt securities

Restricted cash

Total assets measured at fair value

Credit line success fee derivative

Total liabilities measured at fair value

There were no transfers between Level 1, 2, or 3 during the three and nine months ended September 30, 2025 and 2024 .

Cash equivalents and marketable securities

All marketable securities were considered available-for-sale as of September 30, 2025 .

The Company did no t hold any investments in marketable securities as of December 31, 2024.

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, gross unrealized holding gains, and fair value of the Company’s cash equivalents and marketable securities by major security type as of September 30, 2025 are summarized in the table below:

September 30, 2025

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)

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Aggregate Estimated Fair Value

Marketable securities, current

treasury securities

government agency securities

Interest receivable as of September 30, 2025 and December 31, 2024 was $ 0.7 million and zero , respectively, and is recorded as a component of prepaid expenses and other current assets on the Company’s condensed balance sheets.

As of September 30, 2025 , none of the Company's marketable securities were in an unrealized loss position.

The Company has no t recognized an allowance for credit losses as of September 30, 2025.

As of September 30, 2025 , all of the Company’s

marketable securities have a remaining contractual maturity of less than one year .

Commercial paper

Corporate debt securities

Total short-term marketable securities

Marketable securities, non-current

treasury securities

Corporate debt securities

Total long-term marketable securities

December 31, 2025

(in thousands)

Amortized Cost

Unrealized Gains

Unrealized Losses

Aggregate Estimated Fair Value

Marketable securities, current

treasury securities

government agency securities

Commercial paper

Corporate debt securities

Total short-term marketable securities

Marketable securities, non-current

treasury securities

Total long-term marketable securities

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

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Accrued expenses and other current liabilities consisted of the following:

As of September 30,

As of March 31,

As of December 31,

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Capital structure

Common stockholders are entitled to dividends if and when declared by the board of directors of the Company, subject to the prior rights of holders of all classes of stock outstanding having priority rights as to dividends.

The holder of each share of common stock is entitled to one vote.

As of September 30, 2025 and December 31, 2024 , no dividends were declared.

Common stock reserved for future issuance, on an as-converted basis, consisted of the following:

As of September 30,

As of December 31,

Series A redeemable convertible preferred stock

Series B redeemable convertible preferred stock

Series C redeemable convertible preferred stock

Series D redeemable convertible preferred stock

Series D-1 redeemable convertible preferred stock

Shares reserved under 2025 Equity Incentive Plan and 2019 Equity Incentive Plan

Stock options, issued and outstanding

Pre-funded warrants, issued and outstanding

Restricted stock units, issued and outstanding

Shares reserved under 2025 Employee Stock Purchase Plan

Initial public offering

In connection with the completion of the initial public offering, the Company’s certificate of incorporation was amended and restated to (i) authorize 500,000,000 shares of common stock, par value $ 0.001 per share and (ii) authorize 10,000,000 shares of undesignated preferred stock, par value $ 0.001 per share, each of which may be issued from time to time by the Company’s board of directors in one or more series.

The amended and restated certificate of incorporation eliminated all references to the previously existing series of convertible preferred stock.

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 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 payable by the Company of approximately $ 8.7 million.

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.

As of September 30, 2025 , no ne of the Pre-Funded Warrants have been exercised.

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 .

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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 Pre-Funded Warrants should be classified as equity with no subsequent remeasurement as long as such warrant continue to be classified as equity.

Redeemable convertible preferred stock

Immediately prior to the closing of the initial public offering in February 2025, the Company’s outstanding redeemable convertible preferred stock automatically converted into 32,586,823 shares of common stock.

No shares of convertible preferred stock were authorized, issued and outstanding at September 30, 2025 .

Equity incentive plan and stock-based compensation expense

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 and stockholders approved the 2025 Equity Incentive Plan, or 2025 Plan, which became effective on January 29, 2025.

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.

2 unchanged sentences

Any outstanding awards granted under the 2019 Plan will remain subject to the terms of the 2019 Plan and applicable award agreements.

As of September 30, 2025 , there were an aggregated 5,749,020 options outstanding under the 2019 Plan and 2025 Plan and 594,825 unvested restricted stock units, or RSUs, outstanding under the 2025 Plan.

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 Company’s board of directors and stockholders approved the 2025 Employee Stock Purchase Plan, or 2025 ESPP, which became effective on January 30, 2025.

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.

During the nine months ended September 30, 2025 , 53,716 shares were issued under the 2025 ESPP.

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) income during the three and nine months ended September 30, 2025 and 2024:

Three Months Ended September 30,

Nine Months Ended September 30,

(in thousands)

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,

(in thousands)

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Total stock-based compensation expense

As of September 30, 2025 , there was $ 30.6 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 2.72 years.

As of September 30, 2025 , there was $ 1.7 million unrecognized share-based compensation cost related to the 2025 ESPP, which is expected to be recognized over a weighted-average period of 1.19 years.

Restricted stock units

In September 2025, the Company issued 594,825 RSUs under the 2025 Plan at a grant date fair value of $ 23.67 per share.

These RSUs vest in equal annual installments over two years, subject to the holder's continued employment with, or services to, the Company on each vesting date.

Each RSU represents the right to receive one share of the Company’s common stock when and if the applicable vesting conditions are satisfied.

Total stock-based compensation expense related to RSUs recognized during the three and nine months ended September 30, 2025 was $ 0.2 million and is included in the stock-based compensation expense table above.

As of September 30, 2025, there was $ 13.9 million of total unrecognized compensation cost related to RSUs that is expected to be recognized over a weighted average period of 1.92 years.

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

6 unchanged sentences

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 September 30, 2025 .

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) income during the second quarter of 2024, at the point in time when control of the license and related know-how was transferred to Trace.

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 & Co., Ltd, or 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.

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 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 not included in the transaction price as of September 30, 2025 .

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.

The $ 150.0 million transaction price was recorded as license revenue in the condensed statements of operations and comprehensive (loss) income during the second quarter of 2024, at the point in time when control of the license and related know-how and materials was transferred to Shionogi.

Neurocrine License Agreement

5 unchanged sentences

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 September 30, 2025 .

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) income during the third quarter of 2024, at the point in time when control of the license and the related know-how and materials was transferred to Neurocrine.

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

3 unchanged sentences

Significant judgment is required to determine both probability and the estimated amount.

No contingent liabilities have been recorded as of September 30, 2025 and December 31, 2024.

No contingent liabilities have been recorded as of March 31, 2026 and December 31, 2025.

Indemnification

1 unchanged sentence

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.

Loan and security agreement

In March 2025, the Company entered into an amendment to the loan and security agreement dated June 2022, that provides for a one-year extension of the $ 50.0 million revolving line of credit maturity date to June 2026.

The revolving line of credit is secured by substantially all of the Company’s assets, except for its intellectual property.

The Company has not elected to draw down any funds from this debt facility as of September 30, 2025 .

Advances under the revolving line may be prepaid and reborrowed by the Company without penalty.

The Company has the option to convert the aggregate principal amount of advances under the line of credit, if any, into a term loan upon maturity of the revolving line of credit.

Advances under the line of credit accrue interest at a variable annum rate of the greater of (i) 0.75 % above the prime rate and (ii) 4.50 %.

The prime rate is defined as the variable rate of interest, per annum, most recently announced by the bank, as its “prime rate,” whether or not such announced rate is the lowest rate available from the bank.

Under the loan and security agreement, the Company was required to pay the bank a success fee of up to $ 2.0 million depending on if the Company closed a sale of substantially all of its assets, consummated a reorganization where the voting stockholders before such transaction held less than 50 % of the voting securities after such transaction, or completed the sale of the Company’s securities in connection with an initial public offering, reverse merger or other similar transaction wherein the Company’s securities were thereafter traded in a public market.

This success fee was deemed to be a freestanding derivative instrument that was bifurcated from the line-of-credit instrument and was initially and subsequently measured at fair value each reporting period.

The fair value of this success fee derivative was estimated utilizing a probability-weighted cash flow approach, including variables for the timing of the related events and other probability estimates, which were deemed to be Level 3 inputs in the fair value hierarchy.

The fair value of this success fee derivative was approximately $ 0.5 million as of December 31, 2024 and was recorded in accrued expenses and other current liabilities on the condensed balance sheets.

In February 2025, the Company paid a success fee of $ 0.5 million pursuant to the terms of the loan and security agreement, upon the completion of the Company’s initial public offering.

No change in fair value of the derivative was recorded for the three and nine months ended September 30, 2025 .

The change in fair value of the derivative of approximately $ 0.2 million and $ 0.3 million for the three and nine months ended September 30, 2024 , respectively, was recorded in interest and other income, net in the condensed statements of operations and comprehensive (loss) income.

Total issuance costs and the debt discount arising from the success fee amounted to $ 0.3 million and were recorded in other assets, which are amortized as interest expense over the commitment period.

The debt discount was fully amortized as of September 30, 2025 .

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,

(in thousands)

Term loan principal amount

End of term charge

Unamortized discount and issuance costs

Total term loan

current portion of term loan

Total term loan, net of current portion

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

Year Ending December 31,

(in thousands)

Total future principal payments

end of term charge

unamortized discount and issuance costs

current portion of term loan

Total term loan, net of current portion

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.

Related party transactions

The Company has paid fees to its founders and certain board members in exchange for consulting services.

During the three and nine months ended September 30, 2025 and 2024 , the Company recorded an immaterial amount of such fees in each of research and development expenses and general and administrative expenses in the condensed statements of operations and comprehensive (loss) income.

The Company’s provision for income taxes is determined using an estimate of the Company’s annual effective tax rate, adjusted for discrete items, if any.

For the three and nine months ended September 30, 2024 , the Company recorded an income tax benefit of $ 0.3 million and an income tax provision of $ 1.4 million, respectively.

No income tax provision was recorded for the three and nine months ended September 30, 2025.

The amount recognized in the comparative periods in 2024 was due to the net income generated during the periods as a result of the recognition of license revenue under the Company’s license agreements as discussed in Note 8, License agreements, resulting in taxable income to the Company.

Based on available objective evidence as of September 30, 2025 and December 31, 2024, the Company believes it is more likely than not that its net deferred tax assets may not be realized.

The primary difference between the effective tax rate and the statutory tax rate relates to the Company’s change in valuation allowance against deferred taxes.

The One Big Beautiful Bill Act of 2025, or the OBBBA, was enacted in the United States in July 2025.

The OBBBA contains several changes to corporate taxation, including permanent repeal of the requirement to capitalize domestic research and experimental expenditures for federal income tax purposes for taxable years beginning after December 31, 2024.

The OBBBA does not materially impact the Company's effective tax rate or cash flows in the current fiscal year.

Net (loss) income per share

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

Three Months Ended September 30,

Nine Months Ended September 30,

Basic (loss) income per share:

Net (loss) income

Allocation of undistributed earnings to participating

Net (loss) income attributable to common stockholders, basic

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.

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,

Weighted-average shares of common stock outstanding

weighted-average shares of common stock subject to

Weighted-average shares of common stock outstanding used in the calculation of (loss) income per share attributable to common stockholders, basic

Net (loss) income per share attributable to common stockholders, basic

Diluted (loss) income per share:

Net (loss) income attributable to common stockholders, basic

After tax effect of assumed conversion of convertible notes

Net (loss) income attributable to common stockholders, diluted

Weighted-average shares of common stock outstanding,

Weighted-average dilutive effect of convertible promissory notes

Weighted-average dilutive effect of equity awards

Weighted-average shares of common stock outstanding,

Net (loss) income per share attributable to common

stockholders, diluted

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

Nine Months Ended September 30,

Weighted-average shares of common stock outstanding used in the calculation of net loss per share, basic and diluted

Net loss per share, basic and diluted

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,

Shares subject to outstanding stock options

1 unchanged sentence

Unvested restricted stock subject to repurchase

Convertible promissory notes

The antidilutive potential common stock table above includes instruments for convertible notes and equity awards that are different tranches and are excluded from the amounts included in the table computing diluted net income (loss) per share.

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements