Cohort 2 fully enrolled; enrollment and dosing now underway for Cohort 3 (final dose level); No cases of amyloid-related imaging abnormalities (ARIA) observed to date; The trial, expected to enroll 128 patients, remains on track to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026. Cambridge, Massachusetts, Sept. 03, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a clinical-stage biotechnology company developing next-generation therapies for Alzheimer ...

U.S. FDA Grants Fast Track Designation for PMN310 in Alzheimer's Disease, enhancing program's potential for priority review PRECISE-AD Phase 1b Trial in Alzheimer's Disease Progressing on Schedule: Over 50% enrolled, no cases of ARIA and no patient dropouts to date Strengthened Financial Position with $21.6 Million in Gross Proceeds Raised in July 2025 Cambridge, Massachusetts, Aug. 13, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the ge ...

"The rapid enrollment in PRECISE-AD is a testament to the urgent need to bring new breakthroughs in treatment to Alzheimer's patients and providers," Dr. David Watson, Chief Executive and Founder of the Alzheimer's Research and Treatment Center and one of the treating physicians in the PRECISE-AD trial stated. "I am encouraged by the mechanism of ProMIS's PMN310, which has been designed to specifically target toxic Aβ oligomers, and has the potential to provide a more favorable product profile and significa ...

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or other jurisdiction. $2.4 million private financing plus an additional $6.8 million of proceeds due to exercise of warrants and $0.8 million from a registered offering for g ...

CAMBRIDGE, Massachusetts, July 22, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company committed to discovery and development of therapeutic antibodies targeting toxic misfolded proteins in neurodegenerative diseases, such as Alzhiemer's disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD), today announced that it has raised $0.8 million at-the-market from an existing healthcare focused institutional investor. The company has ent ...

Core Insights - ProMIS Neurosciences Inc. has received Fast Track designation from the FDA for its lead therapeutic candidate PMN310, aimed at treating Alzheimer's disease [1][2][3] - The Fast Track designation is intended to expedite the development of therapies addressing serious conditions and unmet medical needs, allowing for enhanced engagement with the FDA [2] - PMN310 is designed to selectively target toxic forms of amyloid-beta, potentially reducing serious side effects associated with current Alzheimer's treatments [3][5] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies for neurodegenerative diseases, including Alzheimer's disease, ALS, and Parkinson's disease [7] - The company utilizes its proprietary EpiSelect™ technology to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are implicated in neurodegenerative diseases [7] Clinical Trials - The ongoing PRECISE-AD Phase 1b trial is evaluating PMN310 in early Alzheimer's patients, focusing on safety, tolerability, pharmacokinetics, and biomarkers [3][6] - Interim biomarker and safety data from the trial are expected to be reported in Q2 2026, with final results anticipated in Q4 2026 [3][6] - The trial is designed to provide insights into the effects of PMN310 on biomarkers and clinical outcomes, with a particular emphasis on assessing the risk of ARIA [6] Market Context - Alzheimer's disease affects over 6 million people in the U.S. and is a leading cause of death and disability among older adults, highlighting the urgent need for safer and more effective treatment options [4] - PMN310 aims to offer a differentiated approach by selectively targeting toxic oligomers, potentially leading to improved efficacy and reduced side effects compared to existing therapies [5]

Core Insights - The FDA has granted Fast Track designation to PMN310, a therapeutic candidate by ProMIS Neurosciences for Alzheimer's disease, highlighting its potential to address an unmet medical need [1][2][3] - PMN310 is designed to selectively target toxic oligomers of amyloid-beta, potentially reducing side effects associated with current treatments [3][5] - The ongoing PRECISE-AD Phase 1b trial is evaluating PMN310's safety, tolerability, and pharmacokinetics, with interim results expected in Q2 2026 [3][6] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies for neurodegenerative diseases, including Alzheimer's, ALS, and Parkinson's [1][7] - The company utilizes its proprietary EpiSelect™ technology to identify Disease Specific Epitopes (DSEs) on misfolded proteins [7][8] Industry Context - Alzheimer's disease affects over 6 million people in the U.S. and is a leading cause of death and disability among older adults, indicating a significant need for effective treatments [4] - The Fast Track program by the FDA aims to expedite the development of therapies for serious conditions, which is crucial for addressing the urgent need for safer and more targeted Alzheimer's treatments [2][4]

Summary of ProMIS Neurosciences (PMN) FY Conference Call Company Overview - **Company**: ProMIS Neurosciences (PMN) - **Industry**: Biotechnology, focusing on neurodegenerative disorders, particularly Alzheimer's disease [1][4] Key Points and Arguments Alzheimer's Disease Opportunity - Alzheimer's disease is a significant global epidemic, especially with the aging population in developed countries [4] - There is a substantial unmet medical need in Alzheimer's treatment, with millions of patients suffering [7] - Current market products, donanemab and lecanemab, are generating revenue but are underperforming expectations [7] - Existing treatments show modest efficacy and significant side effects, particularly ARIA (amyloid-related imaging abnormalities) [8][9] ProMIS's Approach - ProMIS aims to develop differentiated therapeutics that address the underlying pathology of Alzheimer's disease [6] - The company is focused on creating antibodies that improve efficacy while reducing side effects, particularly ARIA [10][18] - The Episelect platform allows ProMIS to selectively target harmful misfolded proteins, avoiding non-pathogenic forms [21][24] ARIA and Its Impact - ARIA occurs in 15-30% of patients treated with current anti-amyloid drugs, leading to significant concerns regarding treatment [13][15] - The presence of ARIA affects physician prescribing habits and overall treatment uptake [14][16] - ProMIS believes it can develop antibodies that minimize ARIA risk while maintaining efficacy [18][41] PMN310 Development - PMN310 is currently in Phase 1b trials (PRECISE AD) with interim results expected in the first half of next year [45][51] - The study involves 100 patients with early Alzheimer's disease, measuring biomarkers, safety, and clinical signals [48][49] - The interim analysis will focus on ARIA incidents, with expectations that PMN310 will show no ARIA liability [53] Pipeline and Future Prospects - ProMIS is also developing PMN267 for ALS and PMN440 for synucleinopathies, with a focus on selectively targeting misfolded proteins [55][59] - The company is exploring a vaccine approach for Alzheimer's that could allow individuals to produce their own PMN310 [62][63] - The potential for PMN310 to become a blockbuster drug exists if it can deliver improved efficacy without ARIA [42] Other Important Content - The discussion highlighted the importance of understanding protein misfolding and the need for targeted therapies in neurodegenerative diseases [22][27] - ProMIS's unique approach to targeting toxic oligomers while avoiding plaque and beneficial monomers sets it apart from competitors [30][31] - The company is optimistic about its ability to deliver a safer and more effective treatment for Alzheimer's, which could significantly impact patient compliance and treatment outcomes [42][43]

Core Viewpoint - ProMIS Neurosciences Inc. is actively engaged in the development of therapeutic antibodies targeting toxic oligomers linked to neurodegenerative diseases, with a focus on Alzheimer's Disease, ALS, and MSA [1][3]. Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company based in Cambridge, Massachusetts, and Toronto, Ontario, specializing in the discovery and development of therapeutic antibodies for misfolded protein diseases [3]. - The company utilizes its proprietary target discovery engine, EpiSelect™, to identify Disease Specific Epitopes (DSEs) on misfolded proteins associated with various neurodegenerative diseases [3]. Product Development - PMN310 is the lead product candidate for Alzheimer's Disease, designed as a humanized monoclonal antibody that selectively targets toxic oligomers while avoiding plaque, potentially enhancing safety and efficacy compared to other therapies [4]. - The PRECISE-AD trial is a Phase 1b clinical study initiated to evaluate the safety, tolerability, and pharmacokinetics of PMN310 in patients with Mild Cognitive Impairment and mild Alzheimer's Disease [5]. - The trial aims to assess the effects of PMN310 on biomarkers related to Alzheimer's pathology and clinical outcomes, with a primary focus on safety and reduced risk of ARIA due to its non-plaque binding nature [5].

First Cohort Completed in PRECISE-AD Trial Evaluating PMN310 in Alzheimer's Disease Six Month Interim Results Expected in 1H 2026 Topline Results Anticipated by end of 2026 CAMBRIDGE, Massachusetts, May 12, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases, such as Alzheimer's disease (AD), amyotrophic lateral sclerosis (AL ...