Alto Neuroscience — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $25.1 million for the quarter ended September 30, 2026, compared to a net loss of $14.2 million for the same period in 2025.
• Research and development expenses were $18.2 million for the quarter, an increase from $10.5 million in the prior-year period, driven primarily by costs associated with the ALTO-207 PACE program.
• General and administrative expenses were $9.1 million for the quarter, up from $4.4 million in the prior-year period, due to increased headcount and related personnel costs.
• Total operating expenses were $27.2 million for the quarter, compared to $15.0 million in the prior-year period.
• Cash, cash equivalents, and restricted cash totaled $319.8 million as of September 30, 2026, compared to $177.0 million as of December 31, 2025.
• The company expects its cash position to fund planned operations through 2030.
• Net loss per share was $0.54 for the quarter, compared to $0.52 in the prior-year period.
• Total assets were $326.5 million as of September 30, 2026, compared to $184.7 million as of December 31, 2025.
• Accumulated deficit was $280.6 million as of September 30, 2026, compared to $201.6 million as of December 31, 2025.

Guidance and Future Outlook:

• Topline data for the PACE-1 trial of ALTO-207 is expected in the second half of 2027.
• Phase 1 study results on the modified-release formulation of ALTO-207 and blinded PACE-1 safety data are expected by early 2027 to inform Phase 3 planning.
• The PACE-2 (Phase 3, adjunctive TRD) trial is on track to initiate in early 2027, pending FDA alignment on trial design.
• The PACE-3 (Phase 3, monotherapy TRD) trial initiation is expected in the second half of 2027, pending FDA alignment.
• Topline data for the ALTO-300 Phase 2b trial in major depressive disorder is expected in the first half of 2027.
• Topline data for the ALTO-100 Phase 2b trial in bipolar depression is expected in the middle of 2027.
• Management anticipates a milestone-rich 2027.

Business Segments and Product Lines:

• ALTO-207: A fixed-dose combination of pramipexole and ondansetron developed for treatment-resistant depression (TRD), estimated to affect approximately 7 million adults in the United States.
• PACE Program: Advancing across three well-controlled trials in TRD; PACE-1 targets approximately 178 adults.
• Pipeline Expansion: Plans to expand ALTO-207 Phase 3 development to include both monotherapy and adjunctive trials to support a broad label.
• ALTO-300: Phase 2b trial ongoing in major depressive disorder (MDD) with enrollment continuing.
• ALTO-100: Phase 2b trial ongoing in bipolar depression (BPD) with enrollment continuing.
• Intellectual Property: Issued method-of-treatment patents cover the use of ondansetron to mitigate pramipexole-related side effects; the portfolio is expected to provide protection extending into the mid-2040s.
• Clinical Evidence: Supporting data includes the PAX-D trial (Cohen's d=0.87 vs. placebo) and the PRIME-PRAXOL trial (Hedges' g=0.62 on anhedonia).

Market and Competitive Landscape:

• No specific market share data or direct competitor comparisons were provided in the press release.
• The company focuses on the neuropsychiatric disorder market, specifically targeting TRD, MDD, and BPD.

Risks and Challenges:

• The press release includes standard forward-looking statement disclaimers regarding uncertainties in clinical trial initiation, progress, and completion.
• Risks include the potential for unsatisfactory clinical trial outcomes, the possibility that interim results may not predict final results, and the risk that financial projections regarding cash runway may be inaccurate.
• Regulatory risks include the need for FDA alignment on trial design and the timing or likelihood of regulatory filings and approvals.

Management Commentary and Tone:

• Amit Etkin, M.D., Ph.D., CEO, stated that the company continued to advance clinical programs and strengthened its financial position ahead of 2027.
• Management expressed confidence that the PACE-1 program remains on track.
• The tone indicates confidence in the expanded Phase 3 development plans for ALTO-207, which now include monotherapy and adjunctive trials.

Other Key Points:

• In July 2026, the company completed an underwritten registered direct offering of 3,776,436 shares of common stock at $26.48 per share.
• The financing generated gross proceeds of $100.0 million and net proceeds of approximately $94.6 million.
• Proceeds are intended to accelerate and expand ALTO-207 development, including the PACE-3 trial, and for general working capital.
• Management will present at the Stifel 2026 Healthcare Conference on November 11 and the Jefferies London Healthcare Conference on November 19.
• The company has implemented enhanced eligibility review and patient data quality procedures which continue to have intended effects on trial execution.