Core Insights - ProMIS Neurosciences Inc. is advancing its lead product candidate PMN310, a humanized monoclonal antibody designed to selectively target toxic oligomers associated with Alzheimer's disease (AD), potentially improving clinical outcomes and quality of life for patients and caregivers [3][10] - The ongoing PRECISE-AD trial is expected to complete enrollment by the end of 2025, with interim results anticipated in Q2 2026 and top-line results in Q4 2026 [1][11] Group 1: Key Findings and Implications - The study published in Alzheimer's & Dementia highlights the importance of selectively targeting soluble toxic Aβ aggregates, showing a correlation between selectivity for these oligomers and clinical efficacy [2][4] - PMN310 demonstrated the highest resistance to monomer competition among tested antibodies, preserving oligomer binding, which may translate into clinical benefits for patients [6][13] Group 2: Safety and Efficacy - PMN310's lack of binding to plaque or vascular deposits suggests a potentially lower risk of amyloid-related imaging abnormalities (ARIA), a common side effect of current anti-amyloid therapies [5][10] - Preclinical studies indicated that high-dose chronic administration of PMN310 did not produce microhemorrhages in plaque-bearing mice, supporting the hypothesis of reduced ARIA risk [6][10] Group 3: Clinical Trial Design - The PRECISE-AD trial is designed to evaluate the safety, tolerability, and pharmacokinetics of PMN310 in patients with Mild Cognitive Impairment due to AD and mild AD, with a targeted enrollment of 128 patients [11] - This trial will be the first to examine the effects of a monoclonal antibody directed solely against toxic amyloid-beta oligomers on biomarkers associated with AD pathology and clinical outcomes [11][13]

ProMIS Neurosciences (NasdaqCM:PMN) FY Conference December 02, 2025 03:25 PM ET Company ParticipantsNeil Warma - CEOConference Call ParticipantsNone - AnalystNoneOf hosting Neil Warma, CEO of ProMIS Neurosciences. Neil, welcome. Thank you so much for making the trek down here to sunny Miami to be with us. But before we delve into Q&A, I would love to hear the state of the business, key data points to look out for the next 12 months or so.Neil WarmaSure. Well, thanks, Michael. And thanks to the organizers fo ...

Cross-trial analysis supports plasma pTau as a potential early predictor of clinical benefit, reinforcing the biomarker-driven design of ProMIS’ PRECISE-AD trial ProMIS on track to leverage new plasma pTau insights with planned Q2 2026 interim readout Cambridge, Massachusetts, Dec. 01, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics and vaccines targeting toxic misfolded proteins in ne ...

Cambridge, Massachusetts, Dec. 01, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a clinical-stage biotechnology company developing next-generation therapies for Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that Neil Warma, Chief Executive Officer of ProMIS Neurosciences, will be participating in a fireside chat and investor one-on-one meetings at the 8th Annual Evercore Healthcare Conference on Tuesday, December 2nd, 2025. The fireside chat will be hel ...

Core Insights - ProMIS Neurosciences Inc. is advancing its lead candidate PMN310 for Alzheimer's disease, with over 85% enrollment in the Phase 1b PRECISE-AD trial and a favorable safety profile reported [1][6][8] - The company has successfully raised capital to support its strategic goals and has strengthened its board with the addition of a new member [2] - Financial results for Q3 2025 show an increase in cash reserves and a significant rise in research and development expenses due to the ongoing clinical trial [5][11] Alzheimer's Disease Program (PMN310) - PMN310 is a humanized IgG1 antibody targeting toxic AβO, which are believed to drive Alzheimer's disease [3][8] - The drug has received Fast Track Designation from the U.S. FDA, indicating its potential to address unmet medical needs in AD [3][8] - The ongoing PRECISE-AD trial is designed to evaluate the safety, tolerability, and pharmacokinetics of PMN310, with interim data expected in Q2 2026 and final results in Q4 2026 [1][9] Financial Highlights - As of September 30, 2025, ProMIS reported cash and cash equivalents of $15.4 million, up from $13.3 million at the end of 2024, primarily due to capital-raising activities [5] - Research and development expenses for Q3 2025 were $9.8 million, a significant increase from $2.6 million in the same period of 2024, reflecting the costs associated with the PRECISE-AD trial [11] - The company reported a loss from operations of $11.8 million for Q3 2025, compared to a loss of $4.4 million in Q3 2024, driven by increased trial expenditures [11][17] Key Pipeline Programs - PMN267, targeting toxic misfolded TDP-43 for amyotrophic lateral sclerosis (ALS), is ready to progress to IND-enabling studies [6] - PMN442, aimed at Parkinson's disease and multiple system atrophy, is also prepared to move forward to IND-enabling studies [6] Company Overview - ProMIS Neurosciences is focused on developing therapeutic antibodies for neurodegenerative diseases, utilizing its proprietary EpiSelect™ platform to identify disease-specific epitopes [7][10] - The company is headquartered in Cambridge, Massachusetts, and Toronto, Ontario, and is committed to addressing the challenges posed by misfolded proteins in various neurodegenerative conditions [7]

Core Insights - ProMIS Neurosciences, Inc. is participating in the Guggenheim 2 Annual Healthcare Innovation Conference on November 10, 2025, where CEO Neil Warma will engage in a fireside chat and one-on-one investor meetings [1][2] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies and vaccines targeting toxic oligomers linked to neurodegenerative diseases, including Alzheimer's disease (AD) [3] - The company utilizes its proprietary EpiSelect™ platform to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are implicated in various neurodegenerative disorders such as AD, ALS, FTD, MSA, and PD [3] Product Development - PMN310 is the lead product candidate for AD, designed as a humanized monoclonal antibody that selectively targets toxic oligomers while avoiding plaque, potentially reducing amyloid-related imaging abnormalities (ARIA) [4] - PMN310 received Fast Track designation from the U.S. FDA in July 2025, indicating its potential for expedited development [4] Clinical Trials - Following positive results from the Phase 1a trial of PMN310, ProMIS initiated the PRECISE-AD Phase 1b clinical trial, which is a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, and pharmacokinetics of multiple ascending doses of PMN310 in patients with Mild Cognitive Impairment and mild AD [5] - The PRECISE-AD trial aims to evaluate the effects of PMN310 on biomarkers associated with AD pathology and clinical outcomes, with a primary focus on safety and reduced risk of ARIA [5] Technology Platform - The EpiSelect platform developed by ProMIS Neurosciences identifies conformational epitopes on toxic misfolded proteins, enabling the generation of selective therapeutic antibodies and vaccines [6] - PMN310 has shown high selectivity for toxic amyloid-beta oligomers without significant reactivity with other forms, potentially minimizing risks associated with targeting vascular amyloid [6]

Core Insights - ProMIS Neurosciences has appointed Slanix Paul Alex to its Board of Directors, enhancing its strategic vision and investor engagement as it advances its Alzheimer's program, PMN310 [1][2] - The company is approaching key inflection points with planned data readouts in Q2 2026 and Q4 2026 from its PRECISE-AD trial evaluating PMN310 [2] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing next-generation therapies for Alzheimer's disease and other neurodegenerative disorders [1][4] - The company utilizes its proprietary EpiSelect™ platform to discover therapeutic antibodies and vaccines targeting toxic oligomers associated with neurodegenerative diseases [4][8] Product Development - PMN310 is ProMIS's lead product candidate, a humanized monoclonal antibody designed to selectively target toxic oligomers while avoiding plaque, potentially reducing the risk of amyloid-related imaging abnormalities (ARIA) [6][7] - The PRECISE-AD trial is a Phase 1b clinical study aimed at evaluating the safety, tolerability, and pharmacokinetics of PMN310 in patients with Mild Cognitive Impairment and mild Alzheimer's disease [7] Investment and Leadership - Slanix Paul Alex, with extensive experience in healthcare investment, is expected to provide valuable insights as ProMIS approaches critical clinical milestones [2][3] - Ally Bridge Group, a significant shareholder, has been instrumental in supporting ProMIS's growth and investment strategy [2][3]

Summary of ProMIS Neurosciences FY Conference Call Company Overview - **Company Name**: ProMIS Neurosciences - **Ticker Symbol**: PMN - **Focus**: Development of antibody therapies targeting protein misfolding, particularly in neurodegenerative diseases like Alzheimer's [3][4] Core Points and Arguments - **Technology Platform**: ProMIS utilizes the EpiSelect platform to generate highly selective antibodies aimed at misfolded proteins, which are implicated in various diseases [4][10] - **Lead Program**: The lead program, PMN310, is currently in a Phase 1b/2 study for Alzheimer's disease, with over 100 patients enrolled across 22 sites in the US [7][8] - **Differentiation**: The company emphasizes the importance of having a differentiated product in the competitive Alzheimer's space, particularly regarding efficacy and safety profiles [5][6] - **Safety Profile**: ProMIS claims that PMN310 has a better safety profile compared to existing treatments, particularly concerning ARIA (Amyloid-related imaging abnormalities), which is a significant side effect associated with current Alzheimer's therapies [6][30] - **Clinical Study Design**: The Phase 1b study is designed to last 12 months, focusing on both biomarker and clinical endpoints, with an interim analysis expected in Q2 of the following year [8][34] - **FDA Fast Track Designation**: PMN310 has received fast track approval from the FDA, indicating the agency's recognition of the potential therapeutic benefit of the drug [8][35] Pipeline and Future Programs - **Additional Candidates**: Besides PMN310, ProMIS is developing other candidates targeting misfolded proteins associated with ALS (PMN267) and Parkinson's disease [12] - **Vaccine Program**: The company is also exploring a vaccine program that follows a similar approach to their therapeutic candidates [12] Market Context - **Unmet Medical Need**: There is a significant unmet medical need in Alzheimer's treatment, with existing products showing modest efficacy and challenging risk-benefit profiles [38] - **Commercial Validation**: Despite the challenges, existing Alzheimer's drugs are generating substantial revenue, indicating a market opportunity for safer and more effective treatments [37][38] Important but Overlooked Content - **Interim Analysis**: The interim analysis will focus on biomarker profiles rather than clinical endpoints, which may provide early insights into the drug's efficacy [32][34] - **Patient Population**: The current study focuses on patients with mild Alzheimer's disease and mild cognitive impairment (MCI), with plans to expand to more moderate to severe cases in future studies [41][42] - **Robust Study Design**: The Phase 1b study is designed to be more comprehensive than typical Phase 2 studies, potentially allowing ProMIS to skip a traditional Phase 2 trial if results are favorable [42] This summary encapsulates the key points discussed during the ProMIS Neurosciences FY Conference Call, highlighting the company's focus on innovative therapies for Alzheimer's disease and its strategic positioning within the market.

Core Insights - ProMIS Neurosciences has received unanimous recommendation from the Data and Safety Monitoring Board (DSMB) to proceed to the third and final dose escalation cohort in the PRECISE-AD Phase 1b clinical trial for PMN310, aimed at treating Alzheimer's disease (AD) [2][3] - The trial is on track to enroll 128 patients and is expected to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026 [1][2] - No cases of amyloid-related imaging abnormalities (ARIA) have been observed to date, indicating a favorable safety profile for PMN310 [1][2][3] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapies for neurodegenerative diseases, particularly Alzheimer's disease [5][6] - The company utilizes its proprietary EpiSelect™ platform to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are implicated in neurodegenerative diseases [5][9] - PMN310 is a humanized IgG1 antibody designed to selectively target toxic amyloid-beta oligomers while avoiding plaque, potentially reducing ARIA liability [7][8] Clinical Trial Details - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of multiple ascending doses of PMN310 in patients with Mild Cognitive Impairment due to AD and mild AD [8] - The trial aims to provide insights into the effects of PMN310 on biomarkers associated with AD pathology and clinical outcomes, with a primary focus on safety [8] - The DSMB has cleared the trial to proceed to the next dosing level, increasing the dose from 10 mg/kg in the second cohort to 20 mg/kg in the final cohort [3][7] Future Outlook - The company anticipates that the ongoing clinical trials will provide critical insights into target engagement, neuronal injury, and potential disease-modifying effects of PMN310 [3][8] - ProMIS Neurosciences plans to discuss clinical progress and corporate updates at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025 [4]

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]