ProMIS Neurosciences (PMN) H.C. Wainwright 27th Annual Global Investment Conference summary

Company overview and technology

• Focuses on protein misfolding diseases using the EpiSelect platform to generate highly selective antibodies.

• Lead program, PMN 310, targets toxic oligomers of amyloid beta in Alzheimer's disease.

• Pipeline includes candidates for ALS, Parkinson's, MSA, and a vaccine program, all targeting disease-specific misfolded proteins.

• Utilizes computational and algorithmic approaches to predict and target misfolded protein epitopes.

Clinical development and trial progress

• Phase Ib study of PMN 310 in Alzheimer's is more than halfway enrolled, with 22 U.S. sites and over 100 patients.

• Study is placebo-controlled, randomized, and spans 12 months, focusing on biomarkers, safety (especially ARIA), and clinical endpoints.

• FDA fast track designation granted; DSMB approved escalation to the final dose cohort.

• Interim analysis expected in Q2 next year, with top-line results in Q4.

Differentiation and safety profile

• PMN 310 designed to selectively target toxic oligomers, avoiding monomers and plaque, aiming for improved efficacy and safety.

• Preclinical and clinical data show no binding to plaque and no cases of ARIA to date, even at high doses.

• Mouse tox studies and Phase Ia in healthy volunteers confirmed safety and blood-brain barrier penetration.

• Robust Phase Ib design may allow skipping Phase II, moving directly to pivotal Phase III if successful.