ANRO · Alto Neuroscience, Inc.

Alto Neuroscience's Q1 2026 results reflect accelerated investment in its precision psychiatry pipeline, with R&D expenses nearly doubling to $20.3 million from $10.0 million year-over-year, driven by clinical trial advancements including the initiation of the Phase 2b trial for ALTO-207 in treatment-resistant depression (TRD). This trial, designed to replicate strong efficacy signals from the independent PAX-D study (Cohen’s d=0.87), enrolled approximately 178 patients and uses MADRS as the primary endpoint aligned with FDA standards, positioning it as potentially pivotal. CEO Amit Etkin highlighted being ahead of schedule on site initiations and recruitment, with Phase 3 planned for early 2027. The $120 million PIPE closed in March, led by Commodore Capital, involved 2.9 million common shares at $20 and pre-funded warrants for 3.1 million shares, extending cash runway to $264.2 million through 2029, covering key milestones like Phase 2b readouts and a potential ALTO-207 NDA. ALTO-101 post-hoc analyses revealed promising EEG biomarkers (e.g., individual alpha peak frequency d=0.59, p=0.001) and attention improvements, supporting exploration of oral formulations via partnerships. Enhanced enrollment processes in ALTO-300 (MDD) and ALTO-100 (BPD) trials improved data quality, screening out 11-13% of patients and confirming 97% PK compliance, but delayed readouts to 1H/mid-2027 without impacting cash guidance. G&A rose modestly to $6.8 million, contributing to a net loss widening to $26.2 million from $15.2 million, consistent with clinical-stage biopharma dynamics amid pipeline progress.