Alto Neuroscience recently released its 10-Q report. Alto Neuroscience, Inc. is a clinical-stage biopharmaceutical company based in Mountain View, California, founded in 2019. Its pipeline includes ALTO-100 for bipolar depression, ALTO-300 for major depressive disorder, ALTO-101 for cognitive impairment associated with schizophrenia, ALTO-203 for major depressive disorder with elevated anhedonia, ALTO-202 for major depressive disorder, and ALTO-208 for Parkinson’s disease.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Alto said its discussion should be read alongside its consolidated financial statements, the related notes, and its audited 2025 year-end financials and MD&A filed March 16, 2026. The company also said the section includes forward-looking statements and that actual results and timing of selected events could differ materially.
Private placements
In October 2025, Alto completed a private placement that brought in approximately $50.0 million in gross proceeds and about $49.7 million in net proceeds after offering expenses. The deal included 3,832,263 shares of common stock and pre-funded warrants for 4,622,251 additional shares, priced at $5.9140 per share and $5.9139 per warrant, respectively, with closing on October 21, 2025.
In March 2026, Alto completed another private placement that generated approximately $120.0 million in gross proceeds and about $114.9 million in net proceeds. That transaction included 2,900,000 shares of common stock and pre-funded warrants for 3,100,000 shares, priced at $20.00 per share and $19.9999 per warrant, with closing on March 17, 2026.
ALTO-207
Alto’s lead discussion in the filing centers on ALTO-207, a fixed-dose combination of pramipexole and ondansetron being developed for treatment-resistant depression. Alto said the Phase 2b trial began in April 2026, is randomized, double-blind, placebo-controlled, and is enrolling about 178 adults who have had two to five prior treatment failures.
The study uses an eight-week double-blind treatment period after a 12-day titration period to a target daily dose of 3.2 mg pramipexole and 15 mg ondansetron. Alto said the primary endpoint is change from baseline in MADRS, topline data are expected in the second half of 2027, and it expects to begin a Phase 3 trial by early 2027 after Phase 3 readiness work and FDA alignment.
Alto acquired ALTO-207 in May 2025. Before the acquisition, Chase Therapeutics’ Phase 2a trial in 32 patients with depression met its primary and secondary endpoints, and patients reached a mean dose of 4.1 mg per day. Alto also cited the PAX-D study, which reported a Cohen’s d of 0.87 for symptom reduction at 12 weeks and continuing through 48 weeks, but noted the regimen was associated with a high rate of adverse effects.
ALTO-300
Alto said ALTO-300, also known as agomelatine, is being developed as a 25 mg adjunctive treatment for MDD in patients identified by an EEG biomarker. The company said the Phase 2b trial is double-blind, placebo-controlled, and randomized, with an expected final analysis sample of about 200 biomarker-positive patients and total enrollment of about 320 patients.
Patients receive 25 mg once daily at bedtime or placebo, in addition to a background antidepressant, over a six-week treatment period, followed by an eight-week open-label extension. Alto said the primary endpoint is change in MADRS from baseline to week six in the biomarker-positive group, and topline data are expected in the first half of 2027.
In February 2025, Alto said an interim analysis supported continuing the study and increasing the biomarker-positive sample. After a blinded site and patient eligibility review, the biomarker-positive population in that interim analysis consisted of 87 patients.
ALTO-100
Alto said ALTO-100 is in a Phase 2b trial in bipolar depression as an adjunctive treatment to a stable mood stabilizer regimen over six weeks. The company said enrollment is ongoing, the target sample is about 200 patients, and topline data are expected in mid-2027.
The filing said a blinded pharmacokinetic analysis from the first cohort showed 96% of samples were PK positive. Alto said it views that result as evidence that operational adjustments made after the completion of the ALTO-100 MDD Phase 2b trial improved execution.
ALTO-101
Alto said its Phase 2 proof-of-concept trial of ALTO-101 in cognitive impairment associated with schizophrenia did not meet statistical significance on primary EEG or cognitive endpoints versus placebo. The company said the study showed directional improvements on certain EEG measures, including theta-ITC with n=83, d=0.34, and p=0.052, and in a more cognitively impaired subgroup of 59 patients, theta-ITC reached d=0.44 and p=0.03.
Alto also said ALTO-101 showed a favorable tolerability profile, with nausea and vomiting rates in line with placebo. It has developed a modified-release oral formulation that it says has improved pharmacokinetic and tolerability characteristics relative to the immediate-release version.
ALTO-203
Alto said ALTO-203 is an oral histamine H3 inverse agonist being advanced for MDD with elevated anhedonia. The filing notes the company completed an exploratory Phase 2 proof-of-concept trial in June 2025. As a result of these announcements, the company's shares have moved -6.66% on the market, and are now trading at a price of $22.99. For the full picture, make sure to review Alto Neuroscience's 10-Q report.
