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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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: 001-42914

MapLight Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)


Delaware	83-2163243
( State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
800 Chesapeake Drive Redwood City, California	94063
(Address of principal executive offices)	(Zip Code)

(617) 984-6300

(Registrant's telephone number, including area code)

N/A

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

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

     Title of each class

     Trading
Symbol(s)

     Name of each exchange on which registered

     Voting Common Stock, par value $0.0001 per share

     MPLT

     Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

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

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


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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

As of May 7, 2026, the registrant had 45,345,676 shares of common stock, $0.0001 par value per share, outstanding, of which 42,618,165 shares were Voting Common Stock and 2,727,511 shares were Non-Voting Common Stock.

Table of Contents


		Page

PART I.	FINANCIAL INFORMATION

Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025 (Unaudited)	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2026 and 2025 (Unaudited)	2
	Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) for the three months ended March 31, 2026 and 2025 (Unaudited)	3
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2026 and 2025 (Unaudited)	4
	Notes to Unaudited Condensed Consolidated Financial Statements	5
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	24
Item 4.	Controls and Procedures	25

PART II.	OTHER INFORMATION	26

Item 1.	Legal Proceedings	26
Item 1A.	Risk Factors	26
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	71
Item 3.	Defaults Upon Senior Securities	71
Item 4.	Mine Safety Disclosures	71
Item 5.	Other Information	71
Item 6.	Exhibits	72
Signatures		73

Table of Contents

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

MapLight Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)


	March 31,			December 31,
	2026			2025
Assets
Current assets:
Cash and cash equivalents	$	55,707		$	46,729
Short-term investments		254,406			258,374
Prepaid expenses and other current assets		17,115			19,567
Total current assets		327,228			324,670
Property and equipment, net		968			1,095
Long-term investments		85,090			147,993
Restricted cash		207			207
Right-of-use asset		5,259			5,488
Other assets		36			59
Total assets	$	418,788		$	479,512
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	3,188		$	3,289
Accrued expenses		10,175			12,049
Lease liability - current		920			891
Total current liabilities		14,283			16,229
Lease liability - noncurrent		4,671			4,911
Total liabilities		18,954			21,140
Commitments and contingencies (Note 11)
Stockholders' equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at March 31, 2026 and December 31, 2025; no shares issued and outstanding at March 31, 2026 and December 31, 2025		—			—
Common stock, $0.0001 par value per share; 500,000,000 shares authorized at March 31, 2026 and December 31, 2025; 45,208,922 and 44,024,088 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively		5			5
Additional paid-in-capital		821,900			819,115
Accumulated other comprehensive loss		(883	)		(228	)
Accumulated deficit		(421,188	)		(360,520	)
Total stockholders' equity		399,834			458,372
Total liabilities and stockholders' equity	$	418,788		$	479,512

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

Table of Contents

MapLight Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)


	Three Months Ended March 31,
	2026			2025
Operating expenses:
Research and development	$	53,684		$	19,787
General and administrative		10,819			3,756
Total operating expenses		64,503			23,543
Loss from operations		(64,503	)		(23,543	)
Other income, net:
Interest income		2,472			811
Other income, net		1,363			392
Net loss	$	(60,668	)	$	(22,340	)
Net loss per share - basic and diluted	$	(1.34	)	$	(29.33	)
Weighted-average number of common shares outstanding - basic and diluted		45,276,763			761,598
Comprehensive loss:
Net loss	$	(60,668	)	$	(22,340	)
Other comprehensive loss:
Unrealized loss on available-for-sale investments		(655	)		(78	)
Comprehensive loss	$	(61,323	)	$	(22,418	)

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

Table of Contents

MapLight Therapeutics, Inc.

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

(in thousands, except share amounts)

(Unaudited)


	Series C Redeemable Convertible Preferred Stock				Series B-1 Redeemable Convertible Preferred Stock				Series B Redeemable Convertible Preferred Stock				Series A-1 Redeemable Convertible Preferred Stock				Series A Redeemable Convertible Preferred Stock				Common Stock				Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Total Stockholders'
	Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Capital		Income			Deficit			Deficit
Balance, December 31, 2024		147,325,527	$	224,992		4,622,496	$	11,981		45,010,383	$	51,094		14,946,844	$	15,963		5,000,000	$	4,793		761,276	$	—	$	5,577	$	163		$	(199,368	)	$	(193,628	)
Stock-based compensation expense		—		—		—		—		—		—		—		—		—		—		—		—		212		—			—			212
Issuance of common stock from exercises of stock options		—		—		—		—		—		—		—		—		—		—		884		—		5		—			—			5
Unrealized loss on available-for-sale investments		—		—		—		—		—		—		—		—		—		—		—		—		—		(78	)		—			(78	)
Net loss		—		—		—		—		—		—		—		—		—		—		—		—		—		—			(22,340	)		(22,340	)
Balance, March 31, 2025		147,325,527	$	224,992		4,622,496	$	11,981		45,010,383	$	51,094		14,946,844	$	15,963		5,000,000	$	4,793		762,160	$	—	$	5,794	$	85		$	(221,708	)	$	(215,829	)


	Common Stock				Additional Paid-In			Accumulated Other Comprehensive			Accumulated			Total Stockholders'
	Shares		Amount		Capital			Loss			Deficit			Equity
Balance, December 31, 2025		44,024,088	$	5	$	819,115		$	(228	)	$	(360,520	)	$	458,372
Stock-based compensation expense		—		—		9,636			—			—			9,636
Issuance of common stock from exercises of stock options		205		—		1			—			—			1
Settlement of restricted stock units, net of employee tax obligations		1,139,648		—		—			—			—			—
Purchases of common stock under the Employee Stock Purchase Plan		44,981		—		650			—			—			650
Payment of employee tax obligations related to vesting of restricted stock units		—		—		(7,502	)		—			—			(7,502	)
Unrealized loss on available-for-sale investments		—		—		—			(655	)		—			(655	)
Net loss		—		—		—			—			(60,668	)		(60,668	)
Balance, March 31, 2026		45,208,922	$	5	$	821,900		$	(883	)	$	(421,188	)	$	399,834

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

Table of Contents

MapLight Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)


	Three Months Ended March 31,
	2026			2025
Cash flows from operating activities
Net loss	$	(60,668	)	$	(22,340	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		162			166
Stock-based compensation expense		9,636			212
Net amortization of premiums and accretion of discounts on investments		(814	)		(257	)
Non-cash lease expense		229			212
Loss on disposal of property and equipment		4			—
Changes in operating assets and liabilities:
Prepaid expenses and other assets		2,475			(193	)
Accounts payable		(111	)		(1,050	)
Accrued expenses		(1,880	)		(2,116	)
Operating lease liabilities		(211	)		(184	)
Net cash used in operating activities		(51,178	)		(25,550	)
Cash flows from investing activities
Maturities and redemptions of investments		67,031			37,500
Purchases of property and equipment		(24	)		—
Net cash provided by investing activities		67,007			37,500
Cash flows from financing activities
Payments of deferred offering costs		—			(52	)
Proceeds from exercises of stock options and employee stock purchase plan issuances		651			5
Payment of employee tax obligations related to vesting of restricted stock units		(7,502	)		—
Net cash used in financing activities		(6,851	)		(47	)
Increase in cash, cash equivalents, and restricted cash		8,978			11,903
Cash, cash equivalents and restricted cash at beginning of period		46,936			38,460
Cash, cash equivalents and restricted cash at end of period	$	55,914		$	50,363
Supplemental disclosure of non-cash investing and financing activities:
Purchase of property and equipment included in accounts payable and accrued expenses	$	15		$	—
Deferred financing costs included in accounts payable and accrued expenses	$	—		$	202

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

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MapLight Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Unaudited)

Nature of the Business

MapLight Therapeutics, Inc. ("MapLight" or the "Company") was incorporated in November 2018 as Alvarado Therapeutics, Inc., a Delaware corporation. In August 2019, the Company changed its name to MapLight Therapeutics, Inc. The Company is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system ("CNS") disorders.

Risks and Uncertainties

The Company is subject to risks and uncertainties common to clinical-stage companies in the biotechnology industry, including, but not limited to, completing preclinical studies and clinical trials, obtaining regulatory approval for its programs, market acceptance of products, developments related to its competitors, dependence on key personnel, the ability to attract and retain qualified employees, reliance on third-party organizations, protection of intellectual property, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company's product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.

Reverse Stock Split, Initial Public Offering and Concurrent Private Placement

In October 2025, the Company effected a 1-for-16.8 reverse stock split of the Company's common stock. This also resulted in an adjustment to the conversion price for each series of the Company's redeemable convertible preferred stock, to the number of shares of common stock underlying outstanding restricted stock units, and to the exercise prices and number of shares of common stock underlying outstanding stock options. The par value per share and authorized number of shares of the Company's common stock were not adjusted as a result of the reverse stock split. All share and per share information relating to common stock for the three months ended March 31, 2025 in the accompanying condensed consolidated financial statements and notes thereto have been retroactively adjusted.

In October 2025, the Company closed its initial public offering ("IPO"), pursuant to which the Company issued and sold an aggregate of 16,962,500 shares of its common stock at a public offering price of $17.00 per share for gross proceeds of $288.4 million. The Company received aggregate net proceeds of $261.6 million from the IPO, including the exercise by the underwriters of their option to purchase additional shares, after deducting underwriting discounts and commissions and offering expenses. Concurrent with the IPO, the Company also closed a private placement, in which the Company issued and sold 476,707 shares of its common stock at a price of $17.00 per share (the "Concurrent Private Placement"). The Company received aggregate net proceeds of $7.5 million from the Concurrent Private Placement, after deducting placement agent fees and private placement expenses.

Upon the closing of the IPO, all of the Company's then-outstanding shares of redeemable convertible preferred stock converted into 25,412,974 shares of common stock, of which 2,727,511 shares were non-voting common stock, at the applicable conversion ratio then in effect. Subsequent to the closing of the IPO, there were no shares of redeemable convertible preferred stock outstanding.

Liquidity and Going Concern

The Company's unaudited condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. The Company has experienced negative operating cash flows since inception, and had an accumulated deficit of $421.2 million as of March 31, 2026. The Company expects to continue to generate operating losses for the foreseeable future. The Company's future viability is dependent on its ability to raise additional capital to finance its operations and pursue its business strategies. There can be no assurances that additional funding will be available on terms acceptable to the Company, or at all.

The Company has funded its operations primarily with proceeds from the sale of capital stock and research and development grants received. The Company's current plans include funding multiple clinical trials, including Phase 2 trials for its lead product candidate, ML-007C-MA, and ML-004, as well as continued advancement of its current and future preclinical programs. Based on its current operating plans and financial position, the Company believes that its existing cash, cash equivalents and investments of $395.2 million will be sufficient to allow the Company to fund its operations for at least twelve months from the date these condensed consolidated financial statements were issued.

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Summary of Significant Accounting Policies

The significant accounting policies and estimates used in the preparation of the accompanying condensed consolidated financial statements are described in the Company's audited consolidated financial statements for the year ended December 31, 2025. There have been no material changes to the Company's accounting policies during the three months ended March 31, 2026.

Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet at March 31, 2026, the condensed consolidated statements of operations and comprehensive loss and the statements of changes in redeemable convertible preferred stock and stockholders' equity (deficit) for the three months ended March 31, 2026 and 2025, and the statements of cash flows for the three months ended March 31, 2026 and 2025 are unaudited. The condensed consolidated interim financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the Company's financial position at March 31, 2026, the results of its operations for the three months ended March 31, 2026 and 2025, its statements of redeemable convertible preferred stock and stockholders' equity (deficit) for the three months ended March 31, 2026 and 2025 and its cash flows for the three months ended March 31, 2026 and 2025. The financial data and other information disclosed in these notes related to the three months ended March 31, 2026 and 2025 are also unaudited. The results for the three months ended March 31, 2026 are not necessarily indicative of results to be expected for the year ending December 31, 2026 or for any other subsequent interim period. The accompanying condensed consolidated balance sheet at December 31, 2025 was derived from the audited annual financial statements; however, certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted from the unaudited interim condensed consolidated financial statements, as is permitted by such rules and regulations.

Recently Issued But Not Yet Adopted Accounting Pronouncements

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires entities to disclose additional information about specific expense categories in the notes to the financial statements. The update is effective for annual periods beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. ASU 2024-03 may be applied retrospectively or prospectively. The Company is currently evaluating the effect of this update on its consolidated financial statements and related disclosures.

Investments

The following tables summarize the amortized cost and estimated fair value of the Company's available-for-sale investments that were included in short-term investments and long-term investments as of March 31, 2026 and December 31, 2025 (in thousands):


	March 31, 2026
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Short-term investments:
U.S. Treasury securities	$	93,136	$	11	$	(105	)	$	93,042
Commercial paper		112,825		2		(86	)		112,741
Corporate debt securities		48,838		2		(217	)		48,623
Long-term investments:
U.S. Treasury securities		45,441		—		(205	)		45,236
Corporate debt securities		40,139		—		(285	)		39,854
	$	340,379	$	15	$	(898	)	$	339,496

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	December 31, 2025
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Short-term investments:
U.S. Treasury securities	$	95,550	$	72	$	(13	)	$	95,609
Commercial paper		137,101		22		(19	)		137,104
Corporate debt securities		25,680		18		(37	)		25,661
Long-term investments:
U.S. Treasury securities		73,072		—		(60	)		73,012
Corporate debt securities		75,192		—		(211	)		74,981
	$	406,595	$	112	$	(340	)	$	406,367

Certain short-term debt securities with original maturities of less than 90 days are included in cash and cash equivalents on the condensed consolidated balance sheets and are not included in the tables above. As of March 31, 2026 and December 31, 2025, all short-term investments had contractual maturities within one year.

The aggregate fair value of available-for-sale securities held by the Company in an unrealized loss position for less than 12 months as of March 31, 2026 was $276.7 million and the unrealized loss associated with available for-sale securities was $0.9 million. There were no available-for-sale securities in a continuous unrealized loss position for greater than 12 months. The Company evaluated its securities for potential impairment and considered the decline in market value to be primarily attributable to current economic and market conditions. Additionally, the Company does not intend to sell the investments in an unrealized loss position and does not expect it will be required to sell the investments before recovery of their amortized cost bases, which may be at the time of maturity. Given the Company's intent and ability to hold such investments until the recovery of their amortized cost basis, and the lack of a significant change in credit risk for these investments, the Company does not consider these investments to be impaired and there were no allowances for credit losses as of March 31, 2026 or December 31, 2025.

Fair Value Measurements

The following tables summarize the Company's cash equivalents and investments (in thousands):


			Fair Value Measurements at March 31, 2026 Using:
	Total		Level 1		Level 2		Level 3
Assets:
Cash equivalents:
Money market funds	$	25,719	$	25,719	$	—	$	—
Short-term investments:
U.S. Treasury securities		93,042		93,042		—		—
Commercial paper		112,741		—		112,741		—
Corporate debt securities		48,623		—		48,623		—
Long-term investments:
U.S. Treasury securities		45,236		45,236		—		—
Corporate debt securities		39,854		—		39,854		—
	$	365,215	$	163,997	$	201,218	$	—

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			Fair Value Measurements at December 31, 2025 Using:
	Total		Level 1		Level 2		Level 3
Assets:
Cash equivalents:
Money market funds	$	30,833	$	30,833	$	—	$	—
Short-term investments:
U.S. Treasury securities		95,609		95,609		—		—
Commercial paper		137,104		—		137,104		—
Corporate debt securities		25,661		—		25,661		—
Long-term investments:
U.S. Treasury securities		73,012		73,012		—		—
Corporate debt securities		74,981		—		74,981		—
	$	437,200	$	199,454	$	237,746	$	—

The Company classifies its money market funds and U.S. Treasury securities as Level 1 assets under the fair value hierarchy as these assets have been valued using quoted market prices in active markets without any valuation adjustment. The Company classifies its commercial paper and corporate debt securities as Level 2 assets under the fair value hierarchy as these assets have been valued using information obtained through a third-party pricing service as of the balance sheet date, using observable market inputs that may include trade information, broker or dealer quotes, bids, offers, or a combination of these data sources.

During the three months ended March 31, 2026 and the year ended December 31, 2025, there were no transfers between levels. The Company uses the carrying amounts of its prepaid expenses and other current assets, restricted cash, other assets, accounts payable and accrued expenses to approximate their fair values due to the short-term nature of these amounts.

Accrued Expenses

Accrued expenses consisted of the following (in thousands):


	March 31,		December 31,
	2026		2025
Research and development	$	6,584	$	4,829
Employee compensation		2,212		6,162
Legal services		702		537
Other		677		521
	$	10,175	$	12,049

Leases

The Company leases office and laboratory space, which are classified as operating leases on the condensed consolidated balance sheets.

The Company has a lease for office and lab space in Redwood City, California, with a term that continues to June 2031. The Company and the lessor have the ability to terminate the lease with 15 months' notice.

The Company has a lease for office space in Burlington, Massachusetts, with a term that continues to May 2029, and with an option to extend the term for an additional five years.

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The following table summarizes the presentation of the Company's operating leases on its condensed consolidated balance sheets (in thousands):


	Balance Sheet Classification	March 31, 2026		December 31, 2025
Assets:
Operating lease assets	Right-of-use asset	$	5,259	$	5,488
Liabilities:
Current:
Operating lease liabilities	Lease liability - current		920		891
Noncurrent:
Operating lease liabilities	Lease liability - non-current		4,671		4,911
Total lease liabilities		$	5,591	$	5,802

The components of lease cost under Accounting Standards Codification Topic 842, Leases included within research and development expenses and general and administrative expenses in the Company's condensed consolidated statements of operations and comprehensive loss were as follows (in thousands):


	Three Months Ended March 31,
Lease Cost	2026		2025
Operating lease costs	$	346	$	346
Variable lease costs		71		70
	$	417	$	416

As of March 31, 2026 and December 31, 2025, the weighted-average remaining lease term for operating leases was 4.9 years and 5.2 years, respectively, and the weighted-average discount rate was 8.7%. During the three months ended March 31, 2026 and 2025, cash paid for amounts included in the measurement of lease liabilities was $0.3 million.

Future minimum annual lease commitments under the Company's operating leases as of March 31, 2026 were as follows (in thousands):


Year Ended December 31,	Amount
2026 (remaining 9 months)	$	1,007
2027		1,376
2028		1,419
2029		1,263
2030		1,163
Thereafter		590
Total lease payments		6,818
Less: imputed interest		(1,227	)
Present value of operating lease liabilities	$	5,591

Redeemable Convertible Preferred Stock

Prior to the IPO in October 2025, the Company had authorized 603,469,745 shares of voting redeemable convertible preferred stock, of which it had designated 5,000,000 shares as Series A Preferred Stock, 14,946,844 shares as Series A-1 Preferred Stock, 45,010,383 shares as Series B Preferred Stock, 147,325,527 shares as Series C Preferred Stock and 391,186,991 shares as Series D Preferred Stock ("Series D"), and had authorized 4,622,496 shares of non-voting redeemable convertible preferred stock, of which it had designated 4,622,496 shares as Series B-1 Preferred Stock (collectively, the "Preferred Stock").

On July 18, 2025, the Company entered into a Series D Preferred Stock Purchase Agreement with certain investors (the "Series D Agreement"). During the year ended December 31, 2025, the Company issued a total of 210,033,285 shares of Series D to investors at a purchase price of $0.95223 per share for gross proceeds of $200.0 million. The Company incurred issuance costs of $1.2 million in connection with the completion of the Series D financing.

In connection with the IPO in October 2025, all outstanding shares of the Company's Preferred Stock automatically converted into an aggregate of 25,412,974 shares of the Company's common stock, of which 2,727,511 shares were non-voting common stock.

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Common Stock

As of March 31, 2026 and December 31, 2025, the Company's amended and restated certificate of incorporation authorized the Company to issue 500,000,000 shares of common stock with a par value of $0.0001 per share, of which 497,272,489 shares were designated as voting common stock and 2,727,511 shares were designated as non-voting common stock. As of March 31, 2026 and December 31, 2025, the Company's amended and restated certificate of incorporation authorized the Company to issue 10,000,000 shares of preferred stock with a par value of $0.0001 per share.

The holders of the voting common stock have the right to one vote for each share of voting common stock held at all meetings of stockholders. Shares of non-voting common stock have no voting rights. Each share of the Company’s non-voting common stock may be converted at any time into one share of voting common stock at the option of its holder by providing written notice to the Company, provided that the holder will be prohibited from converting non-voting common stock into voting common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 4.99% of the total number of shares of the Company’s voting common stock then issued and outstanding, which percentage may be increased to such other percentage not to exceed 19.99% upon 61 days’ notice to the Company or decreased at any time upon notice to the Company. Dividends may be paid when, as and if declared by the Board, subject to the rights of the preferred stock to receive dividends prior and in preference to the common stock. As of March 31, 2026, no cash dividends had been declared or paid.

As of March 31, 2026 and December 31, 2025, the Company had reserved the following shares of voting common stock:


	March 31,		December 31,
Voting Common Stock	2026		2025
Common stock incentive awards issued and outstanding		9,590,346		9,142,493
Non-voting common stock, as converted		2,727,511		2,727,511
Common stock available for future grant under the 2025 Equity Incentive Plan		2,548,327		589,586
Common stock available for future issuance under the Employee Stock Purchase Plan		845,259		450,000
		15,711,443		12,909,590

Stock-Based Compensation

2019 Equity Incentive Plan

In February 2019, the Company adopted the 2019 Equity Incentive Plan (the "2019 Plan"). All employees, officers, directors, and consultants were eligible to be granted options to purchase common stock, restricted stock and restricted stock units under the terms of the 2019 Plan. Upon the effectiveness of the 2025 Plan (as defined below), the 2019 Plan was terminated and no further issuances were made under the 2019 Plan, although it continues to govern the terms of any equity grants that remain outstanding under the 2019 Plan.

All stock option grants were non-statutory stock options except option grants to employees (including officers and directors) intended to qualify as incentive stock options under the Internal Revenue Code of 1986, as amended. Incentive stock options could not have been granted at less than the fair market value of the Company's common stock on the date of grant, as determined in good faith by the Board at its sole discretion. Nonqualified stock options could have been granted at an exercise price established by the Board at its sole discretion (which had not been less than fair market value on the date of grant) and the vesting periods could have varied. Vesting periods were generally four years and are determined by the Board. Stock options became exercisable as they vested. Options granted under the 2019 Plan expire no more than ten years from the date of grant.

2025 Equity Incentive Plan

In October 2025, the Board adopted and approved, and the Company's stockholders approved, the 2025 Equity Incentive Plan (the "2025 Plan"), which became effective immediately prior to the execution of the underwriting agreement related to the Company's IPO. The 2025 Plan allows the Company to make equity-based and cash-based incentive awards to its employees, directors, and consultants. The 2025 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSUs and other stock-based awards. Initially, up to 11,500,000 shares were reserved for issuance under the 2025 Plan, which is the sum of: (i) 4,300,000 new shares, plus (ii) up to 7,200,000 shares of common stock subject to awards granted under the 2019 Plan that, after the effective date of the 2025 Plan, expire or otherwise terminate without having been exercised in full or are forfeited or repurchased. In addition, the number of shares reserved and available for issuance under the 2025 Plan automatically increased on January 1, 2026 by 2,201,204 shares and will increase each January 1 thereafter through January 1, 2035, by five percent of the aggregate number of shares of voting common stock and non-voting common stock issued and outstanding and shares of common stock issuable upon exercise of outstanding pre-funded warrants, if any, as of the immediately preceding December 31 or such lesser number of shares of common stock as determined by the Board. Options granted under the 2025 Plan expire no more than ten years from the date of grant.

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The shares of common stock underlying any awards under the 2025 Plan and the 2019 Plan that are forfeited, canceled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock, expire, or are otherwise terminated (other than by exercise) will be added back to the shares of common stock available for issuance under the 2025 Plan.

As of March 31, 2026, there were 2,548,327 shares of common stock available for future grants under the 2025 Plan.

2025 Employee Stock Purchase Plan

In October 2025, the Board adopted and approved, and the Company's stockholders approved, the 2025 Employee Stock Purchase Plan (the "2025 ESPP"), which became effective immediately prior to the execution of the underwriting agreement related to the Company's IPO. A total of 450,000 shares of common stock were initially reserved for issuance under the 2025 ESPP. The number of shares of common stock that may be issued under the 2025 ESPP automatically increased on January 1, 2026 by 440,240 shares and will increase each January 1 thereafter through January 1, 2035, by the lesser of (i) one percent of the outstanding number of shares of voting common stock and non-voting common stock issued and outstanding and shares of common stock issuable upon exercise of outstanding pre-funded warrants, if any, as of the immediately preceding December 31 and (ii) 900,000 shares of common stock, or such lesser number of shares as determined by the Board. As of March 31, 2026, 845,259 shares of common stock were reserved for issuance under the 2025 ESPP.

During the three months ended March 31, 2026, 44,981 shares of the Company's common stock were issued related to the 2025 ESPP. During the three months ended March 31, 2026, stock-based compensation expense recognized related to the 2025 ESPP was $0.2 million.

Stock Options

A summary of the stock option activity during the three months ended March 31, 2026 is as follows:


	Number of Options			Weighted Average Exercise Price		Weighted Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding as of December 31, 2025		3,865,381		$	14.30		8.85	$	12,625
Granted		530,555			16.37
Exercised		(205	)		5.55
Forfeited and expired		(15,359	)		16.70
Outstanding as of March 31, 2026		4,380,372		$	14.54		8.75	$	25,354
Exercisable as of March 31, 2026		874,582		$	5.35		5.39	$	13,098

Stock options generally vest over four years, with 25% vesting approximately one year after grant and 75% vesting in equal monthly installments thereafter, subject to the recipient’s continued service with the Company through each vesting date. The total fair value of options vested was $0.1 million and $0.2 million for the three months ended March 31, 2026 and 2025, respectively. The weighted-average grant date fair value of options granted during the three months ended March 31, 2026 was $12.95. As of March 31, 2026, unrecognized stock-based compensation expense related to unvested stock options was $41.9 million, which is expected to be recognized over a weighted average period of 3.47 years.

Restricted Stock Units

Restricted stock units ("RSUs") generally vest over four years, with 25% vesting approximately one year after grant and 75% vesting in equal quarterly installments thereafter, subject to the recipient’s continued service with the Company through each vesting date. RSUs issued under the 2025 Plan include a service condition. RSUs issued under the 2019 Plan included both service and performance conditions. The performance condition required a liquidity event in order to vest, which was satisfied in connection with the IPO in October 2025. The two vesting requirements needed to be satisfied on or before the expiration date (the earlier of seven years after the issue date or termination of employment) or else the RSUs would have been immediately forfeited. The RSUs could not vest in whole or in part if only one of the two requirements were satisfied on or before the expiration date.

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A summary of the RSU activity during the three months ended March 31, 2026 is as follows:


	Number of Shares			Weighted Average Grant Date Fair Value
Outstanding at December 31, 2025		5,277,112		$	13.08
Granted		174,270			16.80
Vested		(211,760	)		15.67
Cancelled		(29,648	)		13.90
Outstanding at March 31, 2026		5,209,974		$	13.09

During the three months ended March 31, 2026 and 2025, 211,760 and no RSUs vested. Of the RSUs that vested during the year ended December 31, 2025, 1,349,275 had not settled as of December 31, 2025 and a de minimis amount had not settled as of March 31, 2026. During the three months ended March 31, 2026, 1,139,648 shares were issued related to the vesting of RSUs. In connection with net settlement of vested RSUs, the Company withheld 417,355 shares to satisfy $7.5 million in tax withholding obligations. As of March 31, 2026, unrecognized stock-based compensation expense related to RSUs was $57.3 million, which is expected to be recognized over a weighted average period of 2.84 years.

Stock-Based Compensation Expense

Stock-based compensation expense is as follows (in thousands):


	Three Months Ended March 31,
	2026		2025
Research and development	$	5,415	$	147
General and administrative		4,221		65
	$	9,636	$	212

10.

Net Loss Per Share

Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts):


	Three Months Ended March 31,
	2026			2025
Numerator:
Net loss	$	(60,668	)	$	(22,340	)
Denominator:
Weighted-average number of common shares outstanding - basic and diluted		45,276,763			761,598
Net loss per share - basic and diluted	$	(1.34	)	$	(29.33	)

The Company's potentially dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following shares from the computation of diluted net loss per share as of March 31, 2026 and 2025 because including them would have had an anti-dilutive effect:


	March 31,
	2026		2025
Redeemable convertible preferred stock		—		12,911,004
RSUs		5,209,974		3,406,154
Stock options		4,380,372		954,208
		9,590,346		17,271,366

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11.

Commitments and Contingencies

Legal Proceedings

The Company may, from time to time, be party to litigation arising in the ordinary course of business. The Company was not subject to any material legal proceedings as of March 31, 2026, and no material legal proceedings are currently pending or, to the best of the Company's knowledge, threatened.

Contractual Obligations

NeuroSolis, Inc. asset purchase agreement

Pursuant to the asset purchase agreement the Company entered into with NeuroSolis, Inc. ("NeuroSolis") to acquire its proprietary M1/M4 agonist molecules and associated intellectual property, the Company had an obligation to potentially issue up to an aggregate of 62,083 shares of the Company's common stock, contingent upon the occurrence of specified development and regulatory milestones. As of March 31, 2026, the Company has made upfront and development milestone payments of $150,000 to NeuroSolis. In June 2025, the Company issued 26,607 shares of the Company's common stock to NeuroSolis upon the initiation of a Phase 2 clinical trial for ML-007C-MA. As of March 31, 2026, up to 35,476 additional shares of the Company's common stock could be issued and the issuance of these shares is reasonably possible if certain milestones are met.

Michael J. Fox Foundation grant agreements

Between February 2020 and August 2022, the Company executed four grant agreements (the "Grants") with the Michael J. Fox Foundation for the purpose of researching Parkinson's disease. The Grants consisted of two-year and three-year research programs totaling $25.7 million.

The Grants are payable in installments over the term of the grant according to certain research milestones and progress reports. Funds received for the purchase of property and equipment are accounted for as a reduction to the carrying value of the corresponding asset. Funds received for the reimbursement of expenses incurred related to research and development are accounted for as a reduction to the associated expense. Funds received prior to corresponding asset purchase or incurred expense are recorded as a deferred grant liability on the condensed consolidated balance sheets.

The Company recognized no grant earnings during the three months ended March 31, 2026 and 2025. As of March 31, 2026 and December 31, 2025, the balance of deferred grant earnings was zero.

The Company may be obligated to make future payments under the Grants, restricted to two times the grant awards received, contingent upon certain net product sales. As of March 31, 2026, the Company was unable to estimate the timing or likelihood of generating the associated future product sales.

Universities and other third parties

The Company may be obligated to make future payments, in addition to nominal annual maintenance fees, under license and collaboration agreements with Stanford University, other universities and other third parties upon the occurrence of future events such as the Company's achievement of specified regulatory and commercial milestones or royalties on net sales. As of March 31, 2026, the Company was unable to estimate the timing or likelihood of achieving these milestones or generating future product sales.

Guarantees

The Company is a party to a number of agreements entered into in the ordinary course of business that contain typical provisions that obligate the Company to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect from the date of execution of the applicable agreement for a period equal to the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain.

As of March 31, 2026, the Company had not experienced any losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves have been established.

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License Agreement

In November 2024, the Company entered into a license agreement with Vanderbilt University ("Vanderbilt") (the "Vanderbilt Agreement"), pursuant to which the Company has been granted an exclusive, royalty-bearing, worldwide sublicensable license to develop, make, have made, use, offer for sale, sell, import and exploit certain compounds and licensed products, and a non-exclusive, royalty-bearing, worldwide, sub-licensable license to use licensed know-how and tool compounds to develop, make, have made, use, offer for sale, sell, import and exploit certain compounds and licensed products.

As initial consideration for the license, the Company made a one-time, non-creditable, non-refundable upfront payment of $0.3 million upon the execution of the agreement. The Company also made a one-time, non-creditable, non-refundable payment of $0.3 million upon the execution of the agreement for the reimbursement of past patenting costs incurred by Vanderbilt. As additional consideration for the license, the Company could be required to pay to Vanderbilt aggregate development and commercial milestone payments of up to $52.4 million. The Company is also required to pay royalties at a low single digit percentage based on annual net sales of licensed products sold by the Company. Such royalty payments are subject to reductions if sales are made in calendar quarters during which there is no valid claim or no market exclusivity for a licensed product. Any such royalties are payable on a country-by-country and licensed product-by-licensed product basis until the expiration of the last to expire valid claim of the licensed patents.

As of March 31, 2026, no milestone payments or royalties have been incurred related to the Vanderbilt Agreement.

12.

Related Party Transactions

Stellaromics, Inc.

In October 2023, the Company entered into an Assignment and Assumption Agreement (the "Stellaromics Agreement") with Stellaromics, Inc. ("Stellaromics"), an entity focused on developing and commercializing a proprietary three-dimensional transcriptomic device inclusive of a confocal, probes, operating software and sample analysis software, pursuant to which in exchange for contributing an exclusive worldwide license for STARmap, a three-dimensional intact tissue sequencing, imaging and analysis technology, the Company received 9.8% of the capital stock of Stellaromics at the time of the closing. As of March 31, 2026, the Company held approximately 3.7% of the outstanding common stock of Stellaromics and approximately 3.7% of all classes of outstanding stock.

Prior to the Stellaromics Agreement, Christopher A. Kroeger, M.D., the Company's Chief Executive Officer, was designated to be a director on the board of directors of Stellaromics. Dr. Kroeger is also an equity holder of Stellaromics. Dr. Kroeger's position on the board of directors of Stellaromics is determined by the stockholders holding a majority of the shares of common stock and preferred stock outstanding of Stellaromics. The Company does not have contractual rights to nominate any members to the Stellaromics board of directors.

In October 2023, Catalyst4, Inc. ("Catalyst") became the largest stockholder of Stellaromics, holding a minority interest of its outstanding capital stock. As of March 31, 2026, Catalyst holds a controlling interest of the outstanding capital stock of Stellaromics. Catalyst is also the largest stockholder of the Company, with a minority equity ownership interest of the Company's outstanding shares as of March 31, 2026 and December 31, 2025.

The Company has significant influence over, but does not control, Stellaromics through its noncontrolling representation on Stellaromics' board of directors and the Company's equity interest in Stellaromics. The Company determined that Stellaromics is a variable interest entity because it does not have sufficient equity at risk to finance its operations without additional subordinated financial support. The Company is not the primary beneficiary as it does not have the power to direct activities that most significantly impact Stellaromics' economic performance. Accordingly, the Company does not consolidate the financial statements of Stellaromics and accounts for its investment using the equity method of accounting. The determination of whether an entity is a variable interest entity and whether the Company is the primary beneficiary of a variable interest entity is based upon the facts and circumstances and requires significant judgments such as whether the entity is a variable interest entity and whether the Company is the primary beneficiary of the entity either individually or via a related party group. The Company's maximum exposure to loss due to its involvement with Stellaromics is the carrying value of the investment. As of December 31, 2024, the carrying value of the investment was $0, and no further losses will be recorded because the Company does not have any obligation to fund future losses.

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Advisor Agreement

In February 2019, the Company entered into an advisor agreement with a member of the Board, pursuant to which the Board member received monthly payments in exchange for his service on the Company's scientific advisory board. During the three months ended March 31, 2025, the Company recorded a de minimis amount of research and development expense relating to the Board member's service on the Company's scientific advisory board. As a result of the compensation the director was to earn for service on the Board, the advisor agreement was amended, effective January 1, 2026, pursuant to which the director would not receive monetary compensation for providing services under the advisor agreement.

13.

Segment Information

The Company manages its operations as a single reportable segment focused on the research and development of product candidates. The accounting policies of the single reportable segment are identical to those described in Note 2 of the Company's audited consolidated financial statements for the year ended December 31, 2025. The chief operating decision maker, who manages the Company's operations on a consolidated basis, assesses performance for the reportable segment using consolidated net loss to monitor budget versus actual results and to determine how to effectively allocate the Company's resources. The measure of segment assets is reported on the condensed consolidated balance sheets as total consolidated assets. The following table presents certain financial data for the Company's reportable segment for the three months ended March 31, 2026 and 2025 (in thousands):


	Three Months Ended March 31,
	2026			2025
Clinical trial expenses	$	24,819		$	1,939
Employee-related research and development expenses		15,993			7,050
Chemistry, manufacturing and controls expenses		6,417			3,956
Preclinical program expenses		5,522			6,081
Other research and development expenses		933			761
Employee-related general and administrative expenses		6,990			2,060
Professional fees and other general and administrative expenses		3,829			1,696
Other segment items(1)		(3,835	)		(1,203	)
Net loss	$	60,668		$	22,340

(1)

Other segment items include interest income and other income, net.

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

You should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and related notes and other financial information included elsewhere in this Quarterly Report and with the audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2025. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, future results of operations and financial position, and our objectives for future operations, includes forward-looking statements that involve risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "might," "intend," "target," "ongoing," "project," "estimate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions intended to identify statements about the future. As a result of many factors, including those factors set forth in the section entitled "Risk Factors" of this Quarterly Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis or set forth elsewhere in this Quarterly Report.

Overview

We are a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system, or CNS, disorders. We were founded by globally recognized leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients. Our discovery platform holds the potential to fill this void by identifying neural circuits causally linked to disease and targeting those circuits for therapeutic modulation. We believe our deep understanding of these causal links between the modulation of defined neural circuits and the resulting changes in disease-specific behaviors will enable us to develop therapeutics that can deliver efficacy, safety, tolerability and ease-of-use advantages to patients and prescribers.

Our lead product candidate, ML-007C-MA, is a fixed-dose combination of an M1/M4 muscarinic agonist, ML-007, co-formulated with a peripherally acting anticholinergic, or PAC, which we are initially developing for the treatment of schizophrenia and Alzheimer's disease psychosis, or ADP. ML-007C-MA is designed to activate both M1 and M4 muscarinic receptors centrally to drive efficacy, while synchronizing the pharmacokinetics of the agonist and antagonist components to mitigate peripheral cholinergic side effects. ML-007 alone, co-administered or co-formulated with the PAC has been evaluated in four Phase 1 trials, with a total of 270 healthy participants enrolled and more than 1,500 doses of ML-007 administered. Based on our clinical and preclinical data, we believe that ML-007C-MA has demonstrated the potential to be a well-tolerated treatment option with convenient dosing, while achieving or exceeding cerebrospinal fluid, or CSF, exposures expected to result in improvement across key symptom domains. We are conducting ZEPHYR, a Phase 2 trial evaluating ML-007C-MA for the treatment of schizophrenia. We have completed enrollment in the ZEPHYR trial with 307 participants enrolled, and we expect to report topline results by mid-August 2026. We are also conducting VISTA, a Phase 2 trial evaluating ML-007C-MA for the treatment of ADP, and we expect to report topline results in the second half of 2027. In December 2025, ML-007C-MA was granted Fast Track designation by the FDA for the treatment of hallucinations and delusions associated with ADP.

Our second clinical stage product candidate, ML-004, is a 5-HT1B/1D agonist that we are developing for the treatment of social communication deficit and/or irritability in autism spectrum disorder, or ASD. We are conducting IRIS, a Phase 2 trial evaluating the efficacy, safety and tolerability of ML-004 in adults and adolescents with ASD. 161 participants were randomized in this trial, and we expect to report topline results by mid-August 2026.

Since our inception in 2018, we have devoted substantially all of our time and efforts to performing research and development activities, raising capital and recruiting management and technical staff to support our operations. To date, we have financed our operations primarily with proceeds from the sales of our redeemable convertible preferred stock and research and development grants received and most recently, with net proceeds from our initial public offering, or IPO, and our concurrent private placement, or Concurrent Private Placement.

We have incurred significant net losses since inception. Our net losses for the three months ended March 31, 2026 and 2025 were $60.7 million and $22.3 million, respectively. As of March 31, 2026, we had an accumulated deficit of $421.2 million. We expect to continue to incur significant and increasing expenses and net losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, seek regulatory approval for such product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel, expand our infrastructure and operate as a public company.

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We expect to incur additional costs associated with operating as a public company, including significant legal, accounting, insurance, investor relations and other expenses that we did not incur as a private company. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. In addition, if we obtain regulatory approval for our product candidates, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities, initially in the United States.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Our failure to raise capital or enter into such agreements as and when needed could have a material adverse effect on our business, results of operations and financial condition.

At this time, due to the inherently unpredictable nature of clinical and preclinical development and given the current stage of our product candidates, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current or future product candidates, if at all. For the same reasons, we are also unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. If we fail to become profitable or sustain profitability on a continuing basis, then we may be unable to raise additional capital, maintain our research and development efforts, expand our business or continue our operations at planned levels, and as a result we may be forced to substantially reduce or terminate our operations.

As of March 31, 2026, we had cash, cash equivalents and investments of $395.2 million. Based on our current operational plans and assumptions, we expect that our existing cash, cash equivalents and investments will be sufficient to fund our operations through 2027. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. If we are unable to raise sufficient funding, we may be unable to continue to operate in the long term. See "—Liquidity and Capital Resources—Plan of Operation and Future Funding Requirements" below.

Components of Our Results of Operations

Revenue

To date, we have not generated any revenue from any sources, including from product sales, and we do not expect to generate any revenue from the sale of products in the foreseeable future.

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for the development of our product candidates and our research activities, including our discovery efforts, and include:

•

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

•

the expenses incurred under agreements with contract research organizations, or CROs;

•

the costs of outside consultants, including their fees and travel expenses;

•

the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials;

•

the costs associated with clinical trials and preclinical studies; and

•

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

We expense research and development costs as incurred. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific activities. Payments for these activities are based on the terms of the individual agreements, which may differ from the timing of costs incurred, and are reflected in our consolidated financial statements as prepaid or accrued research and development expenses.

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We typically use our employee and infrastructure resources across our development programs and therefore we do not allocate personnel costs, license payments made under our licensing arrangements or other internal costs to specific development programs or product candidates. We also do not track external expenses by specific development program or product candidate.

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase substantially for the foreseeable future as we initiate and conduct clinical trials, advance our preclinical programs and continue to discover and develop additional product candidates.

The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time consuming. We cannot reasonably estimate the nature, timing and estimated costs of the efforts that will be necessary to complete development of our current or future product candidates. There are numerous risks and uncertainties associated with the duration and cost of successfully developing product candidates, which can vary significantly, including:

•

successful and timely completion of preclinical studies;

•

initiation and successful patient enrollment in, and completion of, clinical trials on a timely basis;

•

gaining agreement on the design, endpoints and implementation of preclinical studies and clinical trials with the U.S. Food and Drug Administration, or the FDA, or any comparable foreign regulatory authority;

•

sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;

•

receiving regulatory approvals or authorizations for conducting future clinical trials;

•

our ability to demonstrate to the satisfaction of the FDA or any comparable foreign regulatory authority that the applicable product candidate is safe and effective for its intended uses;

•

our ability to demonstrate to the satisfaction of the FDA or any comparable foreign regulatory authority that the applicable product candidate's benefit risk assessment for its proposed indication is acceptable;

•

timely receipt of marketing approvals for our product candidates from applicable regulatory authorities;

•

the extent of any required post-marketing approval commitments to applicable regulatory authorities;

•

establishing and scaling up, either alone or with third-party manufacturers, manufacturing capabilities of clinical supply for our clinical trials and commercial manufacturing, if any of our product candidates are approved;

•

effectively competing with other therapies available on the market or in development; and

•

successfully identifying and developing, acquiring or in-licensing additional product candidates to expand our pipeline.

A change in the outcome of any of these variables with respect to the development of our current and future product candidates may significantly change the costs and timing associated with the development of those product candidates and we may never succeed in achieving regulatory approval for any of our product candidates. As a result of these uncertainties, we are unable to precisely forecast the duration and completion costs of our research and development activities.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries, benefits and other related costs, including stock-based compensation, for personnel in our executive, finance, business development and administrative functions. General and administrative expenses also include legal fees relating to intellectual property and corporate matters; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.

We expect that our general and administrative expenses will increase in the future as we increase our personnel headcount to support our continued clinical development efforts, research and development activities, manufacturing activities and related expansion of our operations. We also anticipate increased expenses associated with being a public company, including costs for audit, legal, regulatory and tax-related services related to compliance with the rules and regulations of the Securities and Exchange Commission, or SEC, and the listing standards of the Nasdaq Stock Market LLC, or Nasdaq, director and officer insurance premiums and investor relations costs.

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Other Income, Net

Interest Income

Interest income consists of interest income earned on our cash, cash equivalents and investments.

Other Income, Net

Other income, net consists primarily of amortization of premiums and accretion of discounts to maturity for available-for-sale debt securities.

Income Taxes

Since our inception, we have not recorded income tax benefits for the net operating losses, or NOLs, incurred or the research and development tax credits generated in each year due to the uncertainty of realizing a benefit from those items. As of December 31, 2025, we had U.S. federal and state net operating loss carryforwards of $96.6 million and $13.1 million, respectively, which may be available to offset future taxable income. The federal net operating loss carryforwards do not expire, but may only be used to offset 80% of annual taxable income. The state net operating loss carryforwards expire beginning in 2039. As of December 31, 2025, we also had federal and state research and development tax credit carryforwards of $13.3 million and $0.2 million, respectively.

Results of Operations

Comparison of the Three Months Ended March 31, 2026 and 2025

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


	Three Months Ended March 31,
	2026			2025			Change
Operating expenses:
Research and development	$	53,684		$	19,787		$	33,897
General and administrative		10,819			3,756			7,063
Total operating expenses		64,503			23,543			40,960
Loss from operations		(64,503	)		(23,543	)		(40,960	)
Other income, net:
Interest income		2,472			811			1,661
Other income, net		1,363			392			971
Net loss	$	(60,668	)	$	(22,340	)	$	(38,328	)

Research and Development Expenses

The following table summarizes our research and development expenses for the periods indicated (in thousands):


	Three Months Ended March 31,
	2026		2025		Change
Clinical trial expenses	$	24,819	$	1,939	$	22,880
Employee-related expenses		15,993		7,050		8,943
Chemistry, manufacturing and controls expenses		6,417		3,956		2,461
Preclinical program expenses		5,522		6,081		(559	)
Other expenses		933		761		172
	$	53,684	$	19,787	$	33,897

Research and development expenses were $53.7 million for the three months ended March 31, 2026, compared to $19.8 million for the three months ended March 31, 2025. The increase in research and development expenses of $33.9 million was primarily due to ongoing advancement of our product candidates, which included an increase of $22.9 million in clinical trial expenses and $8.9 million in employee-related expenses, including an increase in stock-based compensation expense of $5.3 million.

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General and Administrative Expenses

The following table summarizes our general and administrative expenses for the periods indicated (in thousands):


	Three Months Ended March 31,
	2026		2025		Change
Employee-related expenses	$	6,990	$	2,060	$	4,930
Professional fees and other expenses		3,829		1,696		2,133
	$	10,819	$	3,756	$	7,063

General and administrative expenses were $10.8 million for the three months ended March 31, 2026, compared to $3.8 million for the three months ended March 31, 2025. The increase in general and administrative expenses of $7.1 million was primarily due to an increase of $4.9 million in employee-related expenses, including an increase in stock-based compensation expense of $4.2 million, and an increase of $2.1 million in professional fees and other expenses, including expenses related to being a publicly-traded company.

Other Income, Net

Interest Income

Interest income was $2.5 million for the three months ended March 31, 2026, compared to $0.8 million for the three months ended March 31, 2025. The increase in interest income of $1.7 million was due to an increase in investments held during the three months ended March 31, 2026 compared to the three months ended March 31, 2025.

Other Income, Net

Other income, net was $1.4 million for the three months ended March 31, 2026, compared to $0.4 million for the three months ended March 31, 2025. The increase of $1.0 million was primarily due to amortization of premiums and accretion of discounts on investments held during the three months ended March 31, 2026.

Liquidity and Capital Resources

Sources of Liquidity

We have incurred significant net losses since inception. We expect to continue to incur significant and increasing expenses and net losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, seek regulatory approval for our current and future product candidates through clinical and preclinical development, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel, scale-up our production capabilities and operate as a public company. As of March 31, 2026, we had cash, cash equivalents and investments of $395.2 million and an accumulated deficit of $421.2 million. Historically, we have financed our operations primarily through issuances of our redeemable convertible preferred stock and research and development grants, and more recently, with proceeds from our IPO and our Concurrent Private Placement.

In October 2025, we closed our IPO, pursuant to which we issued and sold an aggregate of 16,962,500 shares of our common stock at a public offering price of $17.00 per share for net proceeds of $261.6 million, after deducting underwriting discounts and commissions and offering expenses. Concurrent with our IPO, we also closed our Concurrent Private Placement, in which we issued and sold 476,707 shares of our common stock at a price of $17.00 per share for net proceeds of $7.5 million, after deducting placement agent fees and private placement expenses.

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Cash Flows

The following table summarizes our cash flows for the periods indicated (in thousands):


	Three Months Ended March 31,
	2026			2025			Change
Net cash provided by (used in):
Operating activities	$	(51,178	)	$	(25,550	)	$	(25,628	)
Investing activities		67,007			37,500			29,507
Financing activities		(6,851	)		(47	)		(6,804	)
	$	8,978		$	11,903		$	(2,925	)

Operating Activities

Our cash flows from operating activities are primarily driven by our use of cash for operating expenses and working capital required to support our business. We have historically generated negative cash flows from operating activities due to expenses incurred for our clinical trials, preclinical studies, and research and development initiatives.

During the three months ended March 31, 2026, net cash used in operating activities was $51.2 million, primarily resulting from our net loss of $60.7 million, which was primarily attributable to our research and development expenses, along with changes in our operating assets and liabilities of $0.3 million, partially offset by $9.2 million of non-cash items.

During the three months ended March 31, 2025, net cash used in operating activities was $25.6 million, primarily resulting from our net loss of $22.3 million, which was primarily attributable to our research and development expenses, along with changes in our operating assets and liabilities of $3.5 million, partially offset by $0.3 million of non-cash items.

Investing Activities

Net cash provided by investing activities was $67.0 million for the three months ended March 31, 2026, compared to net cash provided by investing activities of $37.5 million for the three months ended March 31, 2025. The increase in cash provided by investing activities during the three months ended March 31, 2026 was driven by the maturities of investments.

Financing Activities

Net cash used in financing activities was $6.9 million for the three months ended March 31, 2026, compared to net cash used in financing activities of a de minimis amount for the three months ended March 31, 2025. The increase in cash used in financing activities was due to the payment of employee tax obligations related to vesting of restricted stock units during the three months ended March 31, 2026.

Plan of Operation and Future Funding Requirements

We use our capital resources mainly to fund operating expenses, including research and development expenditures. We plan to increase our research and development expenses for the foreseeable future as we continue clinical trial activities, advance our preclinical programs into the clinic and continue to discover and develop additional product candidates. At this time, due to the inherently unpredictable nature of clinical and preclinical development and given the early stage of our product candidates, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current product candidates or any future product candidates, if any. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

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The timing and amount of our operating expenditures will depend largely on:

•

the scope, timing, progress, costs and results of discovery efforts, preclinical development and clinical trials for our current or future product candidates;

•

the number of clinical trials required for regulatory approval of our current or future product candidates;

•

the costs, timing and outcome of regulatory review of any of our current or future product candidates;

•

the costs associated with acquiring or licensing additional product candidates, technologies or assets, including the timing and amount of any milestones, royalties or other payments due in connection with our acquisitions and licenses;

•

the cost of manufacturing clinical and commercial supplies of our current or future product candidates;

•

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights;

•

the effectiveness of our platform in identifying additional targets and indications of interest;

•

our ability to maintain existing and establish new, strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;

•

the costs and timing of future commercialization activities, including manufacturing, marketing, market access, sales and distribution, for any of our product candidates for which we receive marketing approval;

•

the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;

•

the expenses to attract, hire and retain skilled personnel;

•

the costs of operating as a public company;

•

our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors;

•

our ability to address any potential supply chain interruptions or delays;

•

our ability to mitigate the impact of adverse macroeconomic or geopolitical conditions, including the ongoing conflicts between Ukraine and Russia and in the Middle East, inflation, tariffs and fluctuations in increased interest rates or other factors, on our preclinical and clinical development or operations;

•

the effect of competing technological and market developments; and

•

the extent to which we acquire or invest in business, products and technologies.

Our existing cash, cash equivalents and investments will not be sufficient to complete development of any product candidate. Accordingly, we will be required to obtain further funding to achieve our business objectives.

Until we can generate substantial revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings. We may also consider entering into collaborations, strategic alliances and licensing arrangements or selectively partnering for clinical development and commercialization as well as funding through other sources. The sale of additional equity or convertible debt may result in additional dilution to our stockholders. The incurrence of debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financial covenants that could restrict our operations or our ability to incur additional indebtedness or pay dividends, among other things. If we raise additional funds through governmental funding, collaborations, strategic partnerships and 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 product candidates or grant licenses on terms that may not be favorable to us. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible and/or suspend or curtail planned programs or cease operations. Any of these actions could materially and adversely affect our business, financial condition, results of operations and prospects.

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Contractual Obligations and Commitments

Leases

We have a lease for laboratory and office space located in Redwood City, California, with a term that extends to June 2031. We and the lessor have the ability to terminate the lease with 15 months' notice. The lease provides for escalating annualized base rent payments starting at $0.8 million and increasing to $1.2 million in the final year of the lease. Remaining lease payments from April 1, 2026 through the end of the lease term total $5.8 million.

We have a lease for office space located in Burlington, Massachusetts, with a term that extends to May 2029, and with an option to extend the term for an additional five years. Remaining lease payments from April 1, 2026 through the end of the lease term total $1.0 million.

Purchase and Other Obligations

We enter into contracts in the normal course of business with CROs and other vendors to assist in the performance of our clinical trials, CMC, research and development and other services and products for operating purposes. These contracts typically do not contain minimum purchase commitments and generally provide for termination on notice. Payments due upon cancellation consist of payments for services provided or expenses incurred to date, including payment of noncancelable obligations of our service providers, up to the date of cancellation, and may also include termination penalties. As of March 31, 2026, the timing, amount or likelihood of such payments are not known.

Grant and License Agreements

We are party to certain grant agreements with the Michael J. Fox Foundation and license and collaboration agreements with NeuroSolis, Stanford University, Vanderbilt University and other third parties. We may be obligated to make certain future payments under these agreements that are contingent upon future events such as our achievement of specified preclinical, clinical, regulatory and commercial milestones or royalties on net product sales under these agreements. As of March 31, 2026, we were unable to estimate the timing or likelihood of achieving these milestones or generating future product sales.

Critical Accounting Policies and Use of Estimates

This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements included elsewhere in this Quarterly Report, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

A summary of our critical accounting policies is presented in Note 2 to our audited consolidated financial statements as of and for the year ended December 31, 2025 included in our Annual Report on Form 10-K. There were no material changes to our critical accounting policies during the three months ended March 31, 2026.

Recent Accounting Pronouncements

For a description of recent accounting pronouncements, see Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.

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Emerging Growth Company and Smaller Reporting Company Status

The JOBS Act provides that, among other things, an "emerging growth company" can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. As an emerging growth company, we have elected to take advantage of the extended transition period to comply with new or revised accounting standards and to adopt certain of the reduced disclosure requirements available to emerging growth companies. As a result of the accounting standards election, we will not be subject to the same implementation timing for new or revised accounting standards as other public companies that are not emerging growth companies, which may make comparison of our financials to those of other public companies more difficult. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies. We intend to rely on certain of the other exemptions and reduced reporting requirements provided by the JOBS Act. As an emerging growth company, 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), and (ii) comply with any requirement that may be adopted by the PCAOB regarding a supplement to the auditor's report providing additional information about the audit and the financial statements (auditor discussion and analysis).

We will remain an emerging growth company until the earliest of (i) December 31, 2030, (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the last day of the fiscal year in which we are deemed to be a "large accelerated filer" as defined in Rule 12b-2 under the Exchange Act of 1934, as amended, or the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700 million as of the last business day of the second fiscal quarter of such year (and we have been a public company for at least 12 months and have filed one annual report on Form 10-K) or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

We are also a "smaller reporting company," as defined in Rule 12b-2 under the Exchange Act. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million.

If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our annual report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

As a "smaller reporting company" as defined by Item 10 of Regulation S-K, we are not required to provide quantitative and qualitative disclosures about market risk.

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Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, including our principal executive officer and our principal financial officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures as of March 31, 2026, the end of the period covered by this Quarterly Report on Form 10-Q. The term "disclosure controls and procedures," as set forth in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms promulgated by the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2026, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We currently are not party to any legal proceedings material to our operations or to which any of our property is the subject, nor are we aware of any such proceedings that are contemplated by a government authority. Regardless of outcome, any such proceedings or claims could have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors and there could be no assurances that any favorable outcomes would be obtained.

Item 1A. Risk Factors.

The following information sets forth risk factors that could cause our actual results to differ materially from those contained in forward-looking statements we have made in this Quarterly Report on Form 10-Q and those we may make from time to time. You should carefully consider the risks described below, in addition to the other information contained in this Quarterly Report on Form 10-Q and our other public filings. Our business, financial condition or results of operations could be harmed by any of these risks. The risks and uncertainties described below are not the only ones we face. Additional risks not presently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business operations.

Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital

We are a clinical-stage biopharmaceutical company with a limited operating history and no history of commercializing products, which may make it difficult to evaluate our approach to the discovery and development of product candidates and the prospects for our future viability.

We are a clinical-stage biopharmaceutical company with a limited operating history. We were formed in 2018 and our operations to date have been limited to organizing, staffing and financing our company, and conducting research and development activities, including developing our platform, conducting clinical trials for our product candidates and establishing our intellectual product portfolio. If we are successful in achieving regulatory approval for our product candidates, we will eventually need to transition from a company with a development focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

Our approach to the discovery and development of product candidates is unproven, and we do not know whether we will be able to develop any product candidates that succeed in clinical development or products of commercial value. Moreover, as an organization, we have not yet demonstrated an ability to obtain regulatory approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, conduct sales and marketing activities necessary for successful product commercialization or generate revenue. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives. Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in clinical development, especially clinical-stage biopharmaceutical companies such as ours. Any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products.

We have incurred substantial losses since our inception. We anticipate incurring substantial and increasing losses for the foreseeable future and may never achieve or maintain profitability.

Investment in biopharmaceutical product development is highly speculative because development efforts entail substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval and become commercially viable. We have no products approved for commercial sale and have not generated any revenue from product sales to date. As a result, we are not profitable, have incurred substantial losses in each period since our inception and expect to incur substantial losses for the foreseeable future.

For the three months ended March 31, 2026 and 2025, our net losses were $60.7 million and $22.3 million, respectively. As of March 31, 2026, we had an accumulated deficit of $421.2 million. Substantially all of our losses have resulted from expenses incurred in connection with the development of our platform, research and development, clinical trials and from general and administrative costs associated with our operations. We expect to incur substantial losses for the foreseeable future, and we expect these losses to increase as we continue the development of our product candidates. We anticipate that our expenses will increase substantially if, and as, we:

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conduct additional clinical trials for ML-007C-MA and ML-004 and advance our preclinical programs;

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seek regulatory approvals for our product candidates that complete clinical trials or any future product candidates;

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commercialize our current product candidates or any future product candidates, if approved;

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oversee, maintain and expand our external manufacturing relationships;

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attract, hire and retain qualified personnel;

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protect, maintain, enforce and defend our rights in our intellectual property portfolio;

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identify additional product candidates and acquire rights from third parties to those product candidates through licenses or other acquisitions, and conduct development activities, including preclinical studies and clinical trials; and

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incur additional costs, including legal, accounting and other expenses, associated with operating as a newly public company.

We have no product candidates approved for commercial sale and have not generated any revenue from the sale of products. Our ability to become and remain profitable depends on our ability to generate revenue. We do not expect to generate significant revenue, if any, unless and until we are able to obtain regulatory approval for, and successfully commercialize, one of our product candidates for either our initial or potential additional indications or any other product candidates we may develop.

Successful commercialization will require achievement of many key milestones, including demonstrating safety and efficacy in clinical trials, obtaining regulatory, including marketing, approval for these product candidates, manufacturing, marketing and selling those products for which we or any of our future collaborators may obtain regulatory approval, satisfying any post-marketing requirements and obtaining reimbursement for our products from private insurance or government payors. Due to the uncertainties and risks associated with these activities, we are unable to accurately and precisely predict the timing and amount of revenue we may generate, the extent of any further losses we may experience and if or when we might achieve profitability. We may never succeed in these activities and, even if we do, we may never generate revenue that is large enough for us to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Additionally, our expenses could increase if we are required by the FDA or any comparable foreign regulatory authority to perform clinical trials in addition to those currently expected, or if there are any additional delays in completing our clinical trials or the development of any of our product candidates.

Even if we succeed in commercializing one or more product candidates, we expect to incur substantial development costs and other expenditures to develop and market additional product candidates. We may also encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue in the future. Our prior losses and expected future losses have had and will continue to have a material adverse effect on our stockholders' equity and working capital and may have a material adverse effect on our business, financial condition, results of operations and prospects. Our failure to become and remain profitable may decrease the market price of our common stock and could impair our ability to raise capital, expand our business, diversify our product portfolio or continue our operations.

We will require substantial additional financing to achieve our goals, and failure to obtain additional capital when needed, or on acceptable terms, could cause us to delay, limit, reduce or terminate our product development or future commercialization efforts.

Our operations have consumed substantial amounts of cash since our inception. We expect to continue to spend substantial amounts of cash to conduct further research and development, preclinical studies and clinical trials of our current and future product candidates, to seek regulatory approvals for our product candidates and to launch and commercialize any products if we receive regulatory approval. As of March 31, 2026, we had $395.2 million of cash, cash equivalents and investments. Based on our current operational plans and assumptions, we believe our existing cash, cash equivalents and investments will be sufficient to fund our operations through 2027. This estimate is based on assumptions that may prove to be wrong, and our future capital requirements and the period through which our existing resources will support our operations may vary significantly from what we expect. We will require additional capital in order to complete clinical development of any of our current programs, and our spending levels will vary based on new and ongoing development and corporate activities. Because the length of time and activities associated with development of our programs and product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and future commercialization activities, if any. Our future capital requirements will depend on many factors, including:

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the scope, timing, progress, costs and results of discovery efforts, preclinical development and clinical trials for our current or future product candidates;

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the number of clinical trials required for regulatory approval of our current or future product candidates;

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the costs, timing and outcome of regulatory review of any of our current or future product candidates;

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the cost of manufacturing clinical and commercial supplies of our current or future product candidates;

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the effectiveness of our platform in identifying additional targets and indications of interest;

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our ability to maintain existing, and establish new, strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;

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the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;

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the expenses to attract, hire and retain skilled personnel;

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the costs of operating as a public company;

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our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors;

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our ability to address any potential supply chain interruptions or delays;

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our ability to mitigate the impact of adverse macroeconomic or geopolitical conditions, including the ongoing conflicts between Ukraine and Russia and in the Middle East, inflation, tariffs and fluctuations in interest rates or other factors, on our preclinical and clinical development or operations;

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the effect of competing technological and market developments; and

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the extent to which we acquire or invest in business, products and technologies.

We will require substantial additional capital to achieve our business objectives. Additional funds may not be available on a timely basis, on favorable terms or at all. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions, including fluctuations in interest rates, inflation and concerns of a recession in the United States or other major markets, potential tariffs and disruptions to and volatility in the credit and financial markets in the United States and worldwide. Weakness and volatility in the capital markets and the economy in general could also increase our costs of borrowing. Such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. Furthermore, to the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that may adversely affect your rights as a holder of our common stock. See "—Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates," below. Any future 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, selling or licensing our assets, making capital expenditures, declaring dividends or encumbering our assets to secure future indebtedness. Such restrictions could materially and adversely impact our business, financial condition, results of operations and prospects.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted and the terms of such securities may include liquidation or other preferences that adversely affect your rights as a common stockholder.

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If we raise additional funds through future collaborations, licenses and other similar arrangements, we may have to relinquish valuable rights to our future revenue streams or product candidates, or grant licenses on terms that may not be favorable to us and/or that may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed or on terms acceptable to us, we may be required to significantly delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Additionally, these circumstances could require that we undertake workforce reductions or restructuring activities in the future. Any of the above events could materially and adversely affect our business, financial condition, results of operations and prospects and cause the price of our common stock to decline.

Risks Related to the Design, Development, Approval and Commercialization of our Product Candidates

If we are unable to successfully identify, develop and commercialize any product candidates, or experience significant delays in doing so, our business, financial condition, results of operations and prospects will be materially and adversely affected.

Our ability to generate revenue from sales of any of our approved product candidates, which we do not expect will occur for at least the next several years, depends heavily on the successful identification, development, regulatory approval and eventual commercialization of product candidates, which may never occur. We have never generated revenue from sales of any products, and we may never be able to develop, obtain regulatory approval for or commercialize, a marketable product. All of our product candidates will require significant clinical development, regulatory approval, establishment of sufficient manufacturing supply, including commercial manufacturing supply, and may require us to build a commercial organization and make substantial investment and significant marketing efforts before we generate any revenue from product sales. We are not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approval for any of our product candidates.

The successful development of our product candidates will depend on several factors, including the following:

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successful and timely completion of preclinical studies and gaining agreement on the design, endpoints and implementation of clinical trials with the FDA or any comparable foreign regulatory authority;

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sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;

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receiving regulatory approvals or authorizations for conducting future clinical trials;

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initiation and successful patient enrollment in, and completion of, clinical trials on a timely basis;

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our ability to demonstrate to the satisfaction of the FDA or any comparable foreign regulatory authority that the applicable product candidate is safe and effective for its intended uses;

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timely receipt of marketing approvals for our product candidates from applicable regulatory authorities;

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the extent of any required post-marketing approval commitments to applicable regulatory authorities;

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effectively competing with other therapies available on the market or in development; and

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successfully identifying and developing, acquiring or in-licensing additional product candidates to expand our pipeline.

Many of these factors are beyond our control, and it is possible that none of our product candidates will ever obtain regulatory approval even if we expend substantial time and resources seeking such approval. If we experience significant delays or are otherwise unable to successfully commercialize our product candidates, our business, financial condition, results of operations and prospects could be materially and adversely affected.

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 product candidates or may negatively impact the perceptions of value or risk of our product candidates or technologies.

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The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.

We are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining regulatory approval from the FDA. Foreign regulatory authorities, such as the European Medicines Agency, impose similar requirements. The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable, but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate's clinical development and may vary among jurisdictions. To date, we have not submitted a New Drug Application, or NDA, to the FDA or similar drug approval submissions to comparable foreign regulatory authorities for any of our product candidates. We must complete additional preclinical or nonclinical studies and clinical trials to demonstrate the safety and efficacy of our product candidates in humans before we will be able to obtain these approvals.

Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. Clinical development is susceptible to the risk of failure inherent at any stage of development, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of AEs that are severe or medically or commercially unacceptable, failure to comply with protocols or applicable regulatory requirements and determination by the FDA or any comparable foreign regulatory authority that a product candidate may not continue development or is not approvable. Additionally, given that ML-007C-MA is a fixed-combination drug product, we will need to demonstrate that each component of the product candidate makes a contribution to the claimed effects (safety and tolerability) and the dosage of each component (amount, frequency, duration) in combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug. In addition, if the PAC we have selected has regulatory challenges, it may adversely impact the development of our fixed-combination drug product. It is possible that even if one of our product candidates has a beneficial effect, that effect will not be detected during clinical evaluation as a result of one or more of a variety of factors, including the size, duration, design, measurements, conduct or analysis of our clinical trials. Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect of one of our product candidates that is greater than the actual positive effect, if any. Similarly, in our clinical trials we may fail to detect toxicity of or intolerability caused by one of our product candidates, or mistakenly believe that our product candidates are toxic or not well tolerated when that is not, in fact, the case. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate.

Our current and future product candidates could fail to receive regulatory approval for many reasons, including the following:

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the FDA or comparable foreign regulatory authorities may disagree as to the design or implementation of our clinical trials;

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we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;

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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

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we may be unable to demonstrate that a product candidate's clinical and other benefits outweigh its safety risks;

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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from clinical trials or preclinical studies;

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the FDA or comparable foreign regulatory authorities may disagree with our study design, including inclusion or exclusion criteria, in our clinical trials;

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the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA to the FDA or other submission or to obtain regulatory approval in the United States, the European Union or elsewhere;

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the FDA or comparable foreign regulatory authorities may find deficiencies with or fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and

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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

This lengthy approval process as well as the unpredictability of clinical trial results may result in our failing to obtain regulatory approval to market any product candidate we develop, which would significantly harm our business, financial condition, results of operations and prospects. There is no assurance that the endpoints and trial designs used for the approval of currently approved drugs will be acceptable for future approvals, including for those of our product candidates. For example, in 2024, the FDA published

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revised draft guidance for drug development in early AD with a recommendation to use consensus diagnostic criteria intended to establish the true biological presence of AD, rather than criteria based on syndromic or other definitions. The FDA and other comparable foreign authorities have substantial discretion in the approval process and determining when or whether regulatory approval will be obtained for any product candidate that we develop. Even if we believe the data collected from our current or future clinical trials of our product candidates are promising, such data may not be sufficient to support approval by the FDA or any other regulatory authority.

In addition, even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates, and therefore materially and adversely impact our business, financial condition, results of operations and prospects.

We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

To obtain the requisite regulatory approvals to commercialize any of our product candidates, we must demonstrate through extensive preclinical studies and clinical trials that our product candidates are safe and effective in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process and our future clinical trials may not be successful.

We may experience delays in initiating or completing our clinical trials or preclinical studies. We may also experience numerous unforeseen events during our clinical trials that could delay or prevent our ability to receive marketing approval or commercialize the product candidates we develop, including:

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regulators, independent institutional review boards, or IRBs, or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial, at a prospective or existing trial site;

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we may not reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

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the number of subjects or patients required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, the number of competing clinical trials being conducted at any given time may be high and result in fewer available patients for any given clinical trial or patients may drop out of clinical trials at a higher rate than we anticipate;

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our third-party contractors, including those manufacturing our product candidates or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

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we may have to amend a clinical trial protocol submitted to regulatory authorities or conduct additional studies to reflect changes in regulatory requirements or guidance, which we may be required to resubmit to an IRB and regulatory authorities for re-examination;

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regulators, IRBs or other reviewing bodies may fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we enter into agreement for clinical and commercial supplies, the supply or quality of product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient, inadequate or not available at an acceptable cost or we may experience interruptions in supply; and

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the potential for approval policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval.

Delays, including delays caused by the above factors, can be costly and could negatively affect our ability to complete a clinical trial or obtain timely marketing approvals. We do not know whether any of our planned preclinical studies or clinical trials will begin on a timely basis or at all, will need to be restructured or will be completed on schedule, or at all. For example, in January 2022, our Phase 2 ML-004 clinical trial was placed on a partial clinical hold by the FDA with respect to the enrollment of adolescents pending submission of safety data from the adult cohorts to the FDA. This partial clinical hold was removed by the FDA in October 2024. In addition, our IND for ML-007C-MA was put on clinical hold by the FDA in May 2024 due to nonclinical findings associated with a single-agent animal study for ML-007. This hold was lifted in July 2024 after the FDA's review of additional clinical and nonclinical data, and we initiated the Phase 2 trials in the United States for ADP and schizophrenia in May 2025 and June 2025, respectively. We cannot assure you that our existing and future INDs will not be subject to additional clinical holds, whether partial or full. If we are not able to complete successful clinical trials on the schedule we expect, we will not be able to obtain regulatory approval, and will not be

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able to commercialize our product candidates, on the timelines we expect. Our product candidate development costs will also increase if we experience delays in testing or regulatory approvals, and we may be required to obtain additional funds to complete clinical trials. We cannot assure you that our clinical trials will begin as planned or be completed on schedule, if at all, or that we will not need to restructure our trials after they have begun. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates, which may harm our business and results of operations. In addition, many of the factors that cause, or lead to, delays of clinical trials may ultimately lead to the denial of regulatory approval of our product candidates, which may materially and adversely affect our business, financial condition, results of operations and prospects.

If we encounter difficulties enrolling patients in our ongoing or planned clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion.

Patient enrollment is affected by many factors, including:

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the patient eligibility criteria defined in the protocol;

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the size of the patient population required for analysis of the trial's primary endpoints;

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the proximity of patients to trial sites;

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the design of the trial;

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our ability to recruit clinical trial investigators with the appropriate competencies and experience;

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competing clinical trials;

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clinicians' and patients' perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications that we are investigating;

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our ability to obtain and maintain patient consents; and

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the risk that patients enrolled in clinical trials will drop out of the trials before completion.

Our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition may reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which may reduce the number of patients who are available for our clinical trials in such clinical trial site.

Our inability to enroll a sufficient number of patients for our clinical trials could result in significant delays or might require us to abandon one or more clinical trials altogether. Our clinical trials may face delays if we are required to restrict enrollment to a more selective group of participants based on age, disease severity or biomarkers, among other factors. For example, in 2024 the FDA published revised draft guidance for drug development in early AD with a recommendation to use consensus diagnostic criteria intended to establish the true biological presence of AD, rather than criteria based on syndromic or other definitions. Delays in patient enrollment may result in increased costs, affect the timing or outcome of the planned clinical trials, product candidate development and approval process, prevent completion of these trials and jeopardize our ability to seek and obtain the regulatory approval required to commence product sales and generate revenue, which could adversely affect our ability to advance the development of our product candidates, cause the value of our company to decline and limit our ability to obtain additional financing, if needed.

Obtaining authorization from regulatory authorities for clinical trials in adolescents and pediatric patients may require longer duration of studies than we currently anticipate, which could delay our development programs or preclude us from pursuing approval in the populations for which we are seeking approval.

Pediatric drug development, including with respect to ML-004 for the treatment of adolescents, may require additional trials to determine safe dosing and long-term safety. These additional trials may require investment of significant additional resources beyond those required for regulatory approval of the drugs in adults. We cannot guarantee that we will receive regulatory approval to commercialize our product candidates in the pediatric populations or the adult population.

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We conduct certain of our clinical trials for our product candidates outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.

We conduct certain clinical trials for our product candidates outside of the United States. The acceptance of data from clinical trials conducted outside the United States or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to Good Clinical Practice, or GCP, regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well designed and well conducted in accordance with GCP regulations and the FDA is able to validate the data from the study through an onsite inspection, if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which could be costly and time consuming and which may result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.

Even if any of our product candidates receives regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenue or become profitable.

We have never commercialized a product, and even if any of our product candidates is approved by the appropriate regulatory authorities for marketing and sale, it may nonetheless fail to achieve sufficient acceptance by physicians, patients, third-party payors and others in the medical community. Many of the indications for our product candidates have well-established standards of care that physicians, patients and payors are familiar with and, in some cases, are available generically. Even if our product candidates are successful in registrational clinical trials, they may not be successful in displacing these current standards of care if we are unable to demonstrate superior efficacy, safety, ease of administration and/or cost-effectiveness. For example, physicians may be reluctant to take their patients off their current medications and switch their treatment regimen to our product candidates. Further, patients often acclimate to the treatment regimen that they are currently taking and do not want to switch unless their physicians recommend switching products or they are required to switch due to lack of coverage and adequate reimbursement. Even if we are able to demonstrate our product candidates' safety and efficacy to the FDA and other regulators, safety or efficacy concerns in the medical community may hinder market acceptance.

Efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources, including management time and financial resources, and may not be successful. If any product candidate is approved but does not achieve an adequate level of market acceptance, we may not generate significant revenue and we may not become profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

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the efficacy and safety of the product;

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the potential advantages of the product compared to competitive therapies;

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the occurrence and severity of any side effects;

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whether the product is designated under physician treatment guidelines as a first-, second- or third-line therapy;

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our ability to offer the product for sale at competitive prices;

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the product's convenience and ease of administration compared to alternative treatments;

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the willingness of the target patient population to try, and of physicians to prescribe, the product;

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limitations or warnings, including distribution or use restrictions contained in the product's approved labeling;

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the strength of our sales, marketing and distribution support, including having sufficient staffing and financial resources;

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MapLight Therapeutics, Inc. 10-Q