Alto Neuroscience Reports First Quarter 2026 Financial Results and Recent Business Highlights
ANRO
– Phase 2b clinical trial of ALTO-207 in treatment-resistant depression (TRD) initiated – – New ALTO-101 analyses support significant effects on EEG markers of general cognition as well as a test of attention – – Closed $120 million PIPE in March 2026; cash balance of approximately $264 million expected to fund planned operations through 2029, including a potential NDA submission for ALTO-207 –
Published on 05/13/2026 at 07:04 am EDT
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today reported financial results for the quarter ended March 31, 2026, and highlighted recent progress across its pipeline of clinical-stage product candidates.
“2026 is off to a strong start across our pipeline, highlighted by the initiation of the Phase 2b trial of ALTO-207 in TRD,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “ALTO-207 is supported by one of the largest independently validated efficacy signals reported in TRD, and we believe the potentially registrational Phase 2b trial is designed to build on those results, and we are ahead of schedule on site initiations and patient recruitment. With $264 million on the balance sheet, Alto is well capitalized — with runway expected to extend through 2029 and, importantly, through a planned Phase 3 trial and potential NDA submission for ALTO-207.”
Pipeline Highlights
ALTO-207: Phase 2b trial in TRD initiated; potentially pivotal trial designed to replicate PAX-D antidepressant effects
ALTO-207 is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist with demonstrated antidepressant effect, and ondansetron, a selective 5-HT3 receptor antagonist. The fixed-dose combination is designed to enable rapid titration to higher pramipexole doses by mitigating the dose-limiting nausea and vomiting historically associated with pramipexole. ALTO-207 is being developed to address the significant unmet medical need in TRD, which is estimated to affect up to 7 million adults in the United States.
ALTO-101: New analyses support biomarker hypothesis
In April 2026, Alto reported topline results from the Phase 2 proof-of-concept (POC) trial of ALTO-101, a brain-penetrant PDE4 inhibitor evaluated as a transdermal formulation in cognitive impairment associated with schizophrenia (CIAS). The pre-specified primary analysis focused on electroencephalography (EEG) markers associated most strongly with CIAS. The trial did not achieve statistical significance on its primary CIAS EEG outcome, theta-band inter-trial coherence (or theta-ITC), though directional improvement was observed in this measure. Subsequent analyses focused on general EEG cognitive biomarkers, as well as exploratory analyses of cognitive test performance, yielding findings that suggest potential clinical effect of ALTO-101 in other cognitive disorders.
Enhanced eligibility review and patient quality measures implemented in ongoing Phase 2b trials for ALTO-300 and ALTO-100
Corporate Updates
Expected Upcoming Milestones
First Quarter 2026 Financial Highlights
Cash Position: As of March 31, 2026, the Company had cash, cash equivalents, and restricted cash of approximately $264.2 million, compared to approximately $177.0 million as of December 31, 2025. The increase reflects net proceeds of approximately $115 million from the March 2026 PIPE, partially offset by cash used in operations during the quarter.
The Company expects its cash balance to support planned operations — including the execution of the ALTO-207 Phase 2b trial, the planned ALTO-207 Phase 3 trial, and the ALTO-300 and ALTO-100 Phase 2b readouts — through 2029, including a potential NDA submission for ALTO-207.
R&D Expenses: Research and development expenses for the quarter ended March 31, 2026, were $20.3 million, as compared to $10.0 million for the same period in 2025.
G&A Expenses: General and administrative expenses for the quarter ended March 31, 2026, were $6.8 million, as compared to $5.7 million for the same period in 2025.
Net Loss: The Company incurred a net loss of $26.2 million for the quarter ended March 31, 2026, as compared to a net loss of $15.2 million for the same period in 2025.
About Alto Neuroscience
Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in treatment-resistant depression, major depressive disorder, bipolar depression, schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X.
Forward-Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “look forward,” “may,” “on track,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto’s expectations with regard to the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform (“Platform”); statements regarding patient compliance and the effectiveness of Alto’s clinical trial execution measures, including its eligibility review and patient and data quality measures, and the impact of those measures on patient and data quality and the timing of trial readouts; statements regarding Alto’s expectations for the design, timing, and results of its Phase 2b and planned Phase 3 trials of ALTO-207; Alto’s expectations with regard to the design and results of its research and development programs and clinical trials, including the timing of enrollment and the timing and availability of data from such trials; Alto’s clinical and regulatory development plans for its product candidates, including the timing or likelihood of regulatory filings and approvals for its product candidates; Alto’s business strategy, financial position, including anticipated cash runway, and the sufficiency of its financial resources to fund its operations through expected milestones; and other statements that are not historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation, progress and completion of clinical trials and clinical development of Alto’s product candidates; the risk that Alto may not realize the intended benefits of its Platform or its eligibility review and patient and data quality measures; availability and timing of results from clinical trials; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that clinical trials may have unsatisfactory outcomes; the risk that Alto’s projections regarding its financial position and expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Alto’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in Alto’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and other filings Alto may make with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law.
Availability of Information on Alto’s Website
Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website.
ALTO NEUROSCIENCE, INC.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share amounts)
(unaudited)
Three months ended
March 31,
2026
2025
Operating expenses:
Research and development
$
20,294
$
9,974
General and administrative
6,844
5,702
Total operating expenses
27,138
15,676
Loss from operations
(27,138
)
(15,676
)
Other income (expense):
Interest income
1,561
1,827
Interest expense
(545
)
(598
)
Loss on debt extinguishment
—
(681
)
Other, net
(115
)
(41
)
Total other income, net
901
507
Net loss
$
(26,237
)
$
(15,169
)
Other comprehensive income (loss):
Change in fair value attributable to instrument specific credit risk
7
134
Foreign currency translation
(16
)
(19
)
Total other comprehensive income (loss)
$
(9
)
$
115
Comprehensive loss
$
(26,246
)
$
(15,054
)
Net loss per share attributable to common stockholders, basic and diluted
$
(0.80
)
$
(0.56
)
Weighted-average number of common shares outstanding, basic and diluted
32,893
27,049
ALTO NEUROSCIENCE, INC.
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
March 31,
December 31,
2026
2025
Cash, cash equivalents, and restricted cash
$
264,262
$
176,984
Total assets
276,259
184,689
Total liabilities
32,890
33,547
Accumulated deficit
(227,871
)
(201,634
)
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