Alto Neuroscience Reports Full Year 2025 Financial Results and Recent Business Highlights

Business Wire

Mon, March 16, 2026 at 6:03 AM EDT 8 min read

– Acquisition of ALTO-207 targets Treatment-Resistant Depression (TRD) with a clinically-validated mechanism; Phase 2b trial on track to be initiated in the first half of 2026 –

– External PAX-D study published in The Lancet Psychiatry demonstrated a 0.87 effect size for the core mechanism of ALTO-207; this effect represents a significantly larger effect size than current standard-of-care treatments –

– ALTO-101 granted FDA Fast Track Designation for CIAS; Topline Phase 2 Proof-of Concept data expected around the end of 1Q 2026 –

– Year-end cash balance of $177 million expected to fund planned operations into 2028, covering four key data readouts across Alto’s precision psychiatry pipeline –

MOUNTAIN VIEW, Calif., March 16, 2026--(BUSINESS WIRE)--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 full year ended December 31, 2025, and highlighted recent progress across its pipeline of clinical-stage product candidates.

"Alto enters 2026 with a very strong clinical and financial foundation," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "The acquisition of ALTO-207 is a potential game-changer for the millions of patients who fail to respond to current depression therapies. We believe the Lancet-published PAX-D study provides robust, independent validation of our approach, and we are moving ALTO-207 into a potentially pivotal Phase 2b trial with high conviction. Our $177 million cash balance puts us in an excellent position to reach the finish line on four major data readouts, providing shareholders with multiple value-inflection points over the next 2 years."

Recent Business Highlights

• Acquisition and Accelerated Development of ALTO-207 for TRD: In June 2025, Alto acquired ALTO-207, a fixed-dose combination of pramipexole (a dopamine D3/D2 agonist) and ondansetron (an antiemetic 5-HT3 receptor antagonist). ALTO-207 is designed to overcome historic tolerability barriers associated with dopamine agonists, potentially unlocking a rapid and robust antidepressant effect for patients in need.

  • Following a successful FDA meeting and a $50 million private placement financing (PIPE) in October 2025, Alto has accelerated the program's development. The Company expects to initiate a potentially pivotal Phase 2b trial in the first half of 2026 and a Phase 3 trial by early 2027.

  • In January 2026, the Company announced the issuance of a new method-of-treatment patent for ALTO-207, which together with its broader estate of issued and pending patents, Alto expects to have patent coverage of ALTO-207 through at least the mid 2040’s.

  • The planned Phase 2b trial of ALTO-207 will be a randomized, double-blind, placebo-controlled study evaluating ALTO-207 as an adjunctive treatment in approximately 178 adults with treatment-resistant depression (TRD). Eligible patients will have experienced two to five prior treatment failures and have a MADRS score ≥25, and will remain on their baseline antidepressant medication. Participants will be randomized 1:1 to receive ALTO-207 or placebo during an eight-week double-blind treatment period, which includes dose titration to a target total daily dose of 3.2mg pramipexole/15mg ondansetron. The study will be conducted at clinical sites in the U.S. and U.K. The primary endpoint is change from baseline in MADRS. The Company expects to report topline data from the trial in the second half of 2027.