Core Insights - ProMIS Neurosciences has received Fast Track designation from the U.S. FDA for its Alzheimer's disease treatment candidate PMN310, enhancing its potential for priority review [2][11] - The PRECISE-AD Phase 1b trial for PMN310 is progressing well, with over 50% of the planned 128 patients enrolled, no cases of amyloid-related imaging abnormalities (ARIA) reported, and no patient dropouts [2][9] - The company has strengthened its financial position by raising approximately $21.6 million in gross proceeds in July 2025 [2][14] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing antibody therapeutics targeting toxic misfolded proteins associated with neurodegenerative diseases, including Alzheimer's disease, ALS, and Parkinson's disease [10] - The company's proprietary platform, EpiSelect™, is designed to identify conformational epitopes on toxic misfolded proteins, enabling the generation of selective therapeutic antibodies [4][10] Clinical Development - PMN310 is a humanized IgG1 monoclonal antibody specifically targeting toxic amyloid-beta oligomers (AβO), which are believed to be a major driver of Alzheimer's disease [5][11] - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, and pharmacokinetics of PMN310, with interim results expected in Q2 2026 and final results in Q4 2026 [12][9] Financial Performance - As of June 30, 2025, ProMIS reported cash and cash equivalents of $4.5 million, an increase from $1.0 million a year earlier [14] - Research and development expenses for Q2 2025 were $8.7 million, significantly higher than $1.6 million in the same period of 2024, primarily due to costs associated with the PRECISE-AD trial [14][20] - The net loss for Q2 2025 was $10.1 million, compared to a net loss of $2.6 million in Q2 2024, reflecting increased clinical trial expenditures [14][20]

Core Insights - ProMIS Neurosciences Inc. is advancing its lead clinical program PMN310 for Alzheimer's disease, with significant progress in patient enrollment for the PRECISE-AD trial, which is expected to yield interim results in the first half of 2026 and topline results by the end of 2026 [1][2][4] Alzheimer's Disease Program (PMN310) - PMN310 is a humanized IgG1 antibody targeting toxic amyloid-beta oligomers, which are believed to drive Alzheimer's disease [3] - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of PMN310, with a planned enrollment of approximately 128 patients across 22 sites in the U.S. [3] - The trial aims to assess the incidence of ARIA (Amyloid-related imaging abnormalities) and other biomarkers, with a primary focus on safety [3][4] - The interim analysis in 2026 will provide early insights into PMN310's potential clinical benefits and tolerability [2][4] Financial Highlights - As of March 31, 2025, ProMIS reported cash and cash equivalents of $8.4 million, down from $13.3 million at the end of 2024 [12] - Research and development expenses increased to $5.5 million in Q1 2025, compared to $2.1 million in Q1 2024, primarily due to costs associated with the PMN310 Phase 1b clinical trial [12] - The net loss for Q1 2025 was $7.3 million, compared to a net loss of $3.6 million in the same period of 2024 [12][18] Other Programs - ProMIS is also advancing its Aβ vaccine program (PMN311) and has initiated a program targeting toxic misfolded TDP-43 for amyotrophic lateral sclerosis (PMN267) [4][5] - The company presented preclinical data at major conferences, highlighting the potential of its vaccine candidates to selectively target toxic oligomers and misfolded proteins associated with neurodegenerative diseases [7][8]