Alto Neuroscience (ANRO -1.57%), a clinical-stage biotechnology company focused on precision psychiatry, released its second-quarter results on August 13, 2025. It reported a net loss of $17.7 million, translating to earnings per share (EPS) of $(0.65) (GAAP). Operating expenses were stable for research and development, while general and administrative costs showed a modest rise. Management highlighted a cash position of $148.1 million at the end of Q2 2025, stating that this will support planned activities and four major clinical study readouts into 2028, underscoring prudent expense control and a stable, if loss-making, quarter for the business.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.65) | $(0.60) | $(0.60) | 8.3% |
| Revenue (GAAP) | $0.0 million | $0.0 million | N/A | – |
| Research & Development Expenses | $13.1 million | $13.2 million | (0.8%) | |
| General & Administrative Expenses | $5.6 million | $5.2 million | 7.7% | |
| Net Loss | $17.7 million | $16.0 million | 10.6% |
Source: Analyst estimates for the quarter provided by FactSet.
About Alto Neuroscience and Its Business Focus
Alto Neuroscience develops targeted therapies for central nervous system (CNS) disorders, using its proprietary precision psychiatry platform. This platform integrates neurocognitive assessments, electroencephalogram (EEG) data, wearable devices, and genetic information. Through machine learning, it identifies biomarkers—measurable indicators—linked to psychiatric conditions and potential drug response.
The company is focused on addressing significant gaps in mental health care, including major depressive disorder, treatment-resistant depression, bipolar depression, and cognitive impairment in schizophrenia. Its approach is to design drugs for these challenging conditions by matching treatments to specific patient subgroups identified through biological markers, aiming for better treatment outcomes and scalability in routine clinical settings.
Highlights and Developments During the Quarter
In Q2 2025, Alto acquired the ALTO-207 program, a drug candidate for treatment-resistant depression, from Chase Therapeutics. This asset brings a late-stage readout opportunity to Alto's pipeline. Prior to acquisition, Phase 2a trial data for ALTO-207, a dopamine agonist combination, showed statistically significant improvement in depressive symptoms compared to placebo (measured by MADRS, a common depression rating scale, with a least squares mean difference at week 8 of -8.2, p=0.025; source: randomized, placebo-controlled Phase 2a trial in 32 patients with depression conducted by Chase Therapeutics before Alto Neuroscience acquired the program). The company plans to launch a pivotal Phase 2b trial by mid-2026, integrating experience and results from the acquired study.
Across its portfolio, Alto maintained progress in its other drug candidates. ALTO-101, a phosphodiesterase 4 (PDE4) inhibitor being tested for cognitive impairment in schizophrenia, moved closer to topline data with patient enrollment ongoing; results are expected in the second half of 2025. The candidate is positioned as a potential first approval in a field where no current treatments exist for cognitive impairment in schizophrenia. ALTO-300, an agomelatine adjunct medication for major depressive disorder, advanced with ongoing Phase 2b enrollment and continued safety monitoring. In its prior Phase 2a trial, no concerning liver enzyme changes were reported, and this positive safety profile persists in the current trial.
ALTO-100, a novel therapy candidate for bipolar depression, continued in Phase 2b testing with results targeted in the second half of 2026. Previous studies in major depressive disorder provided the signal to proceed into this population. For ALTO-203, a histamine H3 inverse agonist intended for patients with high anhedonia (loss of interest or pleasure) in major depressive disorder, Alto reported the identification of a biomarker to select patients most likely to respond, replicating promising pharmacodynamic effects observed in earlier studies. The company will decide on future development paths after all data are fully reviewed and presented.
General and administrative expenses for the quarter ended June 30, 2025, were $5.6 million, compared to $5.2 million for the same period in 2024. Management confirmed that its cash, cash equivalents, and restricted cash declined by $20.6 million over the six months from December 31, 2024, to June 30, 2025, ending at $148.1 million at the end of Q2 2025. Interest income reduced compared to the prior-year period, and the company maintained a share count of 27.07 million at the end of Q2 2025.
No dividends were announced or changed; the company does not pay a dividend. The pipeline’s progress and expense patterns align with previous periods, reflecting stable operations focused on late-stage clinical development.
Looking Ahead: Management Guidance and Investor Considerations
Management estimates its $148.1 million in available cash as of June 30, 2025, is sufficient to fund planned operations through at least 2028. This projection covers four upcoming major clinical trial readouts, including those for ALTO-101, ALTO-300, ALTO-207, and ALTO-100. No new or updated financial guidance for revenue or profit was released for the coming quarters or full year. Product revenue is not anticipated until late-stage trials are completed, regulatory approval is achieved, and the commercialization process begins.
The company emphasized continued progress in advancing its pipeline and strategic use of its precision psychiatry platform as differentiators. Investors should monitor clinical trial timelines, including the upcoming ALTO-101 topline data in the second half of 2025 and the initiation of the ALTO-207 Phase 2b trial planned for mid-2026, as disclosed by Alto Neuroscience in its Q2 2025 earnings release. Increases in administrative or research costs or changes in the pace of clinical development could affect the company’s cash runway. ANRO does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
