ProMIS Neurosciences (PMN) Q4 2025 earnings summary

Executive summary

• PRECISE-AD Phase 1b Alzheimer's trial fully enrolled with 144 participants, exceeding the target of 128, and showing strong patient interest in PMN310's potential.

• PMN310 continues to demonstrate a favorable safety profile, with no treatment-related serious adverse events reported after over 12 months of dosing.

• Six-month blinded interim analysis expected in early Q3 2026; top-line data anticipated in early 2027.

• Fast Track Designation granted by the FDA in July 2025, potentially expediting development.

Financial highlights

• Net loss for the year ended December 31, 2025 was $39.7 million, reflecting increased R&D investment.

• Cash position at year-end 2025 was $6.1 million.

• Research and development expenses rose to $33.4 million in 2025 from $10.6 million in 2024, driven by PRECISE-AD trial costs.

• General and administrative expenses increased to $6.8 million in 2025 from $6.2 million in 2024.

• February 2026 private placement raised $75.5 million, extending cash runway through 2027.

Outlook and guidance

• Six-month assessments for PRECISE-AD expected in Q2 2026, with blinded interim analysis in early Q3 2026.

• Full patient dosing to be completed by year-end 2026; unblinded top-line data expected in early 2027.

• Cash resources expected to fund operations through 2027, including completion of the PRECISE-AD trial.

• Strategic goal to advance directly into a single registrational study, pending trial results and FDA feedback.