ProMIS Neurosciences (PMN) H.C. Wainwright 28th Annual Global Investment Conference summary

Company overview and technology

• Focuses on neurodegenerative diseases using monoclonal antibodies to target misfolded proteins, with a platform originating from University of British Columbia and now based in Cambridge, MA.

• Lead candidate, PMN310, is in clinical trials for Alzheimer's, with additional pipeline assets for ALS and Parkinson's.

• Technology enables selective targeting of toxic oligomers, avoiding monomers and plaque, differentiating from current market therapies.

• Strong patent position and leadership team, with robust financial backing through 2027 following a $175 million financing.

Clinical trial design and interim results

• Phase I-B study in early Alzheimer's (MCI) enrolled 144 patients across 22 U.S. sites, fully enrolled and dosed by December, with top-line results expected Q1 2027.

• Study is placebo-controlled, double-blind, with three dosing arms and a 3:1 randomization, conducted over 12 months.

• Interim six-month analysis showed a superb safety profile, with zero cases of ARIA-E and no treatment-related serious adverse events or dropouts.

• Biomarker analysis indicated a 15% decline in p-tau217 and similar trends in MTBR-tau243, suggesting target engagement.

• Safety and biomarker signals were consistent even in high-risk APOE4 carriers, a population underserved by current therapies.

Market opportunity and future plans

• Current Alzheimer's drugs have modest efficacy and significant ARIA-related side effects, leaving a large unmet need for safer, more effective therapies.

• PMN310's differentiated mechanism and safety profile position it to capture significant market share, especially in preclinical and high-risk populations.

• Fast Track designation from FDA enables efficient regulatory engagement.

• Planning for a phase III registration study and development of a subcutaneous formulation is underway.

• Financial resources are sufficient to support ongoing development and pipeline expansion beyond upcoming data milestones.