alto-20250930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________________

FORM 10-Q

_________________________

(Mark One)


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

For the quarterly period ended September 30, 2025


o			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 001-41944

_________________________

Alto Neuroscience, Inc.

(Exact name of registrant as specified in its charter)

_________________________


Delaware			83-4210124
(State or Other Jurisdiction of Incorporation or Organization)			(I.R.S. Employer Identification No.)

650 Castro Street, Suite 450 Mountain View, CA			94041
(Address of Principal Executive Offices)			(Zip Code)

(650) 200-0412

Registrant’s Telephone Number, Including Area Code

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

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

ANRO

New York Stock Exchange

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 x No o

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 x No o

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

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

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

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

The number of shares of registrant’s Common Stock outstanding as of November 7, 2025 was 31,066,335.

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		Page
Part I - Financial Information
	Item 1. Financial Statements (Unaudited)	F-1
	Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations	23
	Item 3. Quantitative and Qualitative Disclosures About Market Risk	39
	Item 4. Controls and Procedures	39
Part II - Other Information
	Item 1. Legal Proceedings	40
	Item 1A. Risk Factors	40
	Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	40
	Item 3. Defaults Upon Senior Securities	41
	Item 4. Mine Safety Disclosures	41
	Item 5. Other Information	41
	Item 6. Exhibits	42
Signatures		43

Unless context otherwise requires, the terms the “Company,” “Alto,” “we,” “us,” “our,” and similar references in this Quarterly Report on Form 10-Q refer to Alto Neuroscience, Inc. and its consolidated subsidiary.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical fact contained in this Quarterly Report, including statements regarding our plans, objectives, goals, strategies, future events, future revenues or performance, financing needs, plans, or intentions relating to product candidates and markets and business trends are forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “plan,” “potential,” “predict,” “project,” “shall,” “should,” “target,” “will,” or “would,” or the negative of these words or other similar terms or expressions.

These statements involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about:

•the initiation, timing, progress, and results of our research and development programs, preclinical studies, any clinical trials, and investigational new drug, or IND, and other regulatory submissions;

•the ability of our approach to reproducibly predict treatment outcomes for product candidates amongst identified patient populations and achieve clinical success;

•our ability to continue to identify appropriate biomarkers for use in further clinical development;

•the timing of and costs involved in obtaining and maintaining regulatory approval of our current product candidates and any future product candidates that we may identify or develop;

•the beneficial characteristics, including potential safety, efficacy, and therapeutic effects, of our product candidates;

•our ability to efficiently and cost-effectively conduct our current and future clinical trials;

•our ability to obtain funding for our operations necessary to complete further development and commercialization of our product candidates, if approved;

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

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

•our ability to identify and develop product candidates for treatment of additional indications;

•the performance of our third-party service providers, including our suppliers and manufacturers;

•the rate and degree of market acceptance and clinical utility for our current product candidates and any other product candidates we may develop;

•the effects of competition with respect to our current product candidates or any of our future product candidates, as well as innovations by current and future competitors in our industry;

•our estimates regarding the potential market opportunities and the number of patients for our product candidates and any future product candidates, if approved for commercial use;

•the implementation of our strategic plans for our business, any product candidates we may develop;

•our intellectual property position, including the scope of protection we are able to establish, maintain, defend and enforce for intellectual property rights covering our product candidates and our Precision Psychiatry Platform;

•our ability to attract and retain key scientific or management personnel;

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•regulatory and legal developments in the United States and foreign countries;

•our ability to attract and retain employees and collaborators with development, regulatory, and commercialization expertise;

•our ability to comply with the terms of our loan agreements and our expectations regarding our ability to access additional tranches thereunder;

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

•the anticipated impact of global economic uncertainty, financial market conditions and geopolitical events, including the conflict between Ukraine and Russia, the regional conflict in the Middle East, geopolitical tensions, high levels of inflation, fluctuating interest rates, and tariffs on our business, results of operations, and financial condition;

•the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; and

•our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act.

These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Quarterly Report and are subject to risks and uncertainties. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

You are urged to carefully review the disclosures we make concerning risks and other factors that may affect our business and operating results under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, or Annual Report, under “Item 1A. Risk Factors” in this Quarterly Report, and in our other reports filed with the Securities and Exchange Commission, or SEC. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in such statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

Any public statements or disclosures by us following this Quarterly Report that modify or impact any of the forward-looking statements contained in this Quarterly Report will be deemed to modify or supersede such statements in this Quarterly Report. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, whether as a result of new information, future events, or otherwise.

Availability of Information on Our Website

We routinely use our investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, we encourage investors and others interested in Alto to review the information it makes public on its investor relations website.

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PART I

FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

Alto Neuroscience, Inc. and Subsidiary

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except per share amounts)


	September 30, 2025		December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	137,816	$	168,229
Prepaid expenses and other current assets	1,632		1,108
Total current assets	139,448		169,337
Restricted cash	500		500
Property and equipment, net	2,029		2,666
Operating right-of-use asset	4,459		5,035
Other assets	570		4
Total assets	$	147,006	$	177,542
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	2,059	$	1,579
Accrued expenses and other current liabilities	6,986		8,429
Total current liabilities	9,045		10,008
Term loan, non-current	20,314		10,254
Convertible Grant Agreement	2,124		1,304
Lease liability, long-term	3,966		4,516
Total liabilities	35,449		26,082
Commitments and contingencies (Note 11)
Stockholders’ equity:
Common stock (par value $0.0001), 500,000 shares authorized; 27,168 and 26,987 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively	3		3
Additional paid-in capital	296,992		289,954
Accumulated deficit	(185,452)		(138,396)
Accumulated other comprehensive income (loss)	14		(101)
Total stockholders’ equity	111,557		151,460
Total liabilities and stockholders’ equity	$	147,006	$	177,542

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

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Alto Neuroscience, Inc. and Subsidiary

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except per share amounts)


	Three months ended September 30,				Nine months ended September 30,
	2025		2024		2025		2024
Operating expenses:
Research and development	$	10,525	$	13,060	$	33,623	$	36,196
General and administrative	4,426		5,826		15,686		15,417
Total operating expenses	14,951		18,886		49,309		51,613
Loss from operations	(14,951)		(18,886)		(49,309)		(51,613)
Other income (expense):
Interest income	1,532		2,500		5,042		6,716
Interest expense	(650)		(349)		(1,894)		(1,042)
Loss on debt extinguishment	—		—		(681)		—
Other, net	(112)		(48)		(214)		(291)
Total other income, net	770		2,103		2,253		5,383
Net loss	$	(14,181)	$	(16,783)	$	(47,056)	$	(46,230)
Other comprehensive income (loss):
Change in fair value attributable to instrument specific credit risk	(12)		—		144		—
Foreign currency translation	(5)		(6)		(29)		(16)
Total other comprehensive income (loss)	(17)		(6)		115		(16)
Comprehensive loss	$	(14,198)	$	(16,789)	$	(46,941)	$	(46,246)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.52)	$	(0.62)	$	(1.74)	$	(1.94)
Weighted-average number of common shares outstanding, basic and diluted	27,104		26,959		27,075		23,878

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

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Alto Neuroscience, Inc. and Subsidiary

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

(in thousands, except per share amounts)


	Preferred Stock			Common Stock			Additional Paid-in Capital		Accumulated Deficit		Accumulated Other Comprehensive Loss		Total Stockholders’ Equity (Deficit)
(Par Value of Shares $0.0001)	Shares (#)	Amount ($)		Shares (#)	Amount ($)
Balance at December 31, 2023	29,919	$	141,477	3,832	$	—	$	5,372	$	(76,965)	$	(79)	$	(71,672)
Exercise of common stock options	—	—		69	—		10		—		—		10
Issuance of common stock for conversion of preferred stock	(29,919)	(141,477)		13,664	2		141,475		—		—		141,477
Exercise of warrant	—	—		73	—		—		—		—		—
Initial public offering of common stock, net of offering cost of $4,643	—	—		9,246	1		132,936		—		—		132,937
Reclassification of warrant to equity	—	—		—	—		1,595		—		—		1,595
Other comprehensive loss	—	—		—	—		—		—		(5)		(5)
Stock compensation expense	—	—		—	—		2,179		—		—		2,179
Net loss	—	—		—	—		—		(13,417)		—		(13,417)
Balance at March 31, 2024	—	$	—	26,884	$	3	$	283,567	$	(90,382)	$	(84)	$	193,104
Exercise of common stock options	—	—		20	—		61		—		—		61
Issuance of common stock for MedRx Agreement	—	—		47	—		735		—		—		735
Other comprehensive loss	—	—		—	—		—		—		(5)		(5)
Stock compensation expense	—	—		—	—		1,888		—		—		1,888
Settlement of initial public offering cost	—	—		—	—		23		—		—		23
Net loss	—	—		—	—		—		(16,030)		—		(16,030)
Balance at June 30, 2024	—	$	—	26,951	$	3	$	286,274	$	(106,412)	$	(89)	$	179,776
Exercise of common stock options	—	—		17	—		67		—		—		67
Other comprehensive loss	—	—		—	—		—		—		(6)		(6)
Stock compensation expense	—	—		—	—		1,998		—		—		1,998
Net loss	—	—		—	—		—		(16,783)		—		(16,783)
Balance at September 30, 2024	—	$	—	26,968	$	3	$	288,339	$	(123,195)	$	(95)	$	165,052

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

F-3

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Alto Neuroscience, Inc. and Subsidiary

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

(in thousands, except per share amounts)


	Preferred Stock			Common Stock			Additional Paid-in Capital		Accumulated Deficit	Accumulated Other Comprehensive Income (Loss)	Total Stockholders’ Equity
(Par Value of Shares $0.0001)	Shares (#)	Amount ($)		Shares (#)	Amount ($)
Balance at December 31, 2024	—	$	—	26,987	$	3	$	289,954

SEC Form 10-Q filed by Alto Neuroscience Inc.