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Alto Neuroscience reported first quarter 2026 results, combining deeper investment in its precision psychiatry pipeline with a much stronger balance sheet. Cash, cash equivalents, and restricted cash rose to about $264.2 million as of March 31, 2026 from $177.0 million, reflecting net proceeds of roughly $115 million from a March 2026 PIPE financing.
The company advanced several key programs, including initiation of a potentially registrational Phase 2b trial of ALTO-207 in treatment-resistant depression, new supportive biomarker data for ALTO-101, and ongoing Phase 2b trials for ALTO-300 and ALTO-100 with enhanced patient-quality controls. Alto now expects topline data in 2027 across these mid‑ to late‑stage trials and guides its current cash runway to fund operations, including a potential NDA submission for ALTO-207, through 2029.
Operating expenses increased as R&D spending roughly doubled year over year, driving a larger net loss of $26.2 million (or $0.80 per share) for the quarter compared with $15.2 million (or $0.56 per share) a year earlier.
Alto Neuroscience filed a shelf registration to permit resale of up to 6,000,000 shares of common stock by recent private placement investors. The shares consist of 2,900,000 issued shares and 3,100,000 shares issuable upon exercise of pre-funded warrants. Alto received approximately $120.0 million gross proceeds from the Private Placement that closed on March 17, 2026. The company will not receive proceeds from resale by the selling stockholders, except for the nominal $0.0001 per-share exercise price if any Pre-Funded Warrants are exercised for cash. The registration covers resale mechanics, selling-stockholder tables (examples provided), and related indemnities and distribution methods. Alto common stock trades on the NYSE under ANRO (closing price shown April 9, 2026: $22.40).
Alto Neuroscience reported topline results from a Phase 2 proof-of-concept trial of ALTO-101 in cognitive impairment associated with schizophrenia. The drug did not achieve statistical significance on primary EEG or cognitive endpoints versus placebo, though directional EEG improvements were seen.
In a more cognitively impaired subgroup, ALTO-101 showed nominally significant benefits on the theta-ITC EEG measure, and several EEG signals improved between day 5 and day 10. ALTO-101 was well tolerated, with nausea and vomiting rates similar to placebo, suggesting its pharmacokinetic profile may address a key limitation of the PDE4 inhibitor class.
Alto has created a modified-release, once-daily oral formulation of ALTO-101 with improved pharmacokinetics and tolerability and plans to seek partners for this program rather than independently advancing ALTO-101 in CIAS. The company is prioritizing its lead program, ALTO-207 for treatment-resistant depression, with a Phase 2b trial in about 178 adults expected to start in the first half of 2026, supported by prior positive Phase 2a data. Management highlighted a cash position of $275 million and multiple advancing clinical programs.
Alto Neuroscience, Inc. is asking stockholders to vote at its virtual 2026 annual meeting on May 12, 2026. Stockholders of record as of March 16, 2026, when 31,945,516 common shares were outstanding, can attend and vote online using a control number.
The meeting will elect two Class II directors, Raymond Sanchez, M.D. and Gwill York, to serve until the 2029 annual meeting, ratify Deloitte & Touche LLP as independent auditor for 2026, and approve amendments to the 2024 Equity Incentive Plan and 2024 Employee Stock Purchase Plan.
The equity plan changes would amend the evergreen formulas so that outstanding pre-funded warrants are treated the same as outstanding common shares when calculating the automatic annual increases to each plan’s share reserve. The Board recommends voting “FOR” all four proposals.
Alto Neuroscience is raising new capital through a private placement of 2,900,000 common shares and pre-funded warrants to purchase 3,100,000 shares at $20.00 per share, for gross proceeds of about $120 million before expenses. The pre-funded warrants have a $0.0001 exercise price and do not expire, with a beneficial ownership cap that cannot exceed 19.9% without advance notice.
The company entered a registration rights agreement to register for resale both the shares sold and the shares underlying the pre-funded warrants, with liquidated damages of 1.0% of each investor’s purchase amount per 30-day period if filing or effectiveness deadlines are missed, subject to caps. Jefferies, BofA Securities, TD Cowen, Stifel, William Blair, and Baird are acting as placement agents.
Alto expects to use the proceeds primarily to fund development of its ALTO-207 program in treatment resistant depression, including a planned Phase 3 trial and potential NDA submission, as well as for working capital and general corporate purposes. After the expected net proceeds, Alto estimates cash and cash equivalents would have been about $275 million as of February 28, 2026.
Alto Neuroscience, Inc. describes a clinical-stage precision psychiatry business built around its proprietary biomarker-driven Platform and a pipeline of seven clinical assets targeting major depressive disorder, bipolar depression, treatment-resistant depression, schizophrenia-related cognitive impairment, and Parkinson’s disease.
Lead program ALTO-207, a fixed-dose combination of pramipexole and ondansetron, is being advanced for treatment-resistant depression with a Phase 2b trial planned for the first half of 2026 and a potential Phase 3 by early 2027. ALTO-300 (agomelatine) is in a Phase 2b adjunctive MDD study enriched by an EEG biomarker, with topline data expected mid-2026.
ALTO-100 is in a Phase 2b bipolar depression trial as adjunctive therapy, partially funded by an up to approximately $11.7 million convertible loan from Wellcome. ALTO-101, a transdermal PDE4 inhibitor for cognitive impairment associated with schizophrenia, has FDA Fast Track designation and a Phase 2 proof-of-concept study expected to read out around the end of the first quarter of 2026. Additional product candidates ALTO-203, ALTO-202, and ALTO-208 are supported by multiple in-licensing and asset purchase agreements, and the company reports a broad global patent estate with expected expiries extending into the 2040s.
Alto Neuroscience reported a full-year 2025 net loss of $63.2 million, or $2.19 per share, driven by research and development spending as its pipeline advances. Research and development expenses were $45.6 million and general and administrative expenses were $20.7 million, both slightly lower than 2024.
Cash, cash equivalents, and restricted cash totaled about $177 million as of December 31, 2025, which the company expects will fund planned operations into 2028. Alto highlighted progress across its precision psychiatry pipeline, including the acquisition and accelerated development of ALTO-207 for treatment-resistant depression, Fast Track status for ALTO-101 in CIAS, and multiple Phase 2b data readouts expected in 2026.
Alto Neuroscience, Inc. reported that President and CEO Amit Etkin had 6,227 shares of common stock withheld on March 1, 2026 to cover taxes upon vesting of previously reported restricted stock units. The shares were valued at $19.69 per share and the filing notes this was not an open market transaction. After this tax-withholding disposition, Etkin directly owned 1,233,949 common shares.