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Alto Neuroscience Reports Third Quarter 2026 Financial Results and Recent Business Highlights

  • PACE-1 trial of ALTO-207 for treatment-resistant depression remains on track with topline data expected in the second half of 2027.
  • Phase 1 data on the modified-release formulation of ALTO-207 & blinded PACE-1 safety data are expected by early 2027 to inform Phase 3 planning.
  • Alto Neuroscience completed a $100 million financing in July 2026, resulting in a cash position of $319.8 million expected to fund operations through 2030.
  • ALTO-207 is a fixed-dose combination of pramipexole & ondansetron designed to mitigate nausea & allow higher dosing for treatment-resistant depression.
  • The PACE-3 Phase 3 monotherapy trial for ALTO-207 is planned to initiate in the second half of 2027, pending FDA alignment.
  • The PACE-2 Phase 3 adjunctive trial for ALTO-207 is expected to initiate in early 2027, running in parallel with PACE-1.
  • Phase 2b trials for ALTO-300 (MDD) & ALTO-100 (bipolar depression) are ongoing, with topline data expected in the first half of 2027 & mid-2027, respectively.
  • Intellectual property for ALTO-207 includes issued patents covering the combination therapy, with protection extending into the mid-2040s.
  • Research & development expenses for the quarter ended September 30, 2026, were $18.2 million, driven by costs associated with the ALTO-207 PACE program.
  • General & administrative expenses for the quarter ended September 30, 2026, were $9.1 million due to increased headcount & personnel costs.
  • The company reported a net loss of $25.1 million for the quarter ended September 30, 2026, compared to $14.2 million in the same period in 2025.
  • Management will present at the Stifel 2026 Healthcare Conference on November 11 & the Jefferies London Healthcare Conference on November 19.