Tillkännagivande • Jul 28
ProMIS Neurosciences Inc. Reports Positive Blinded Six-Month Interim Safety and Biomarker Data for PMN310 in PRECISE-AD Phase 1b Alzheimer’s Disease Trial ProMIS Neurosciences Inc. announced positive blinded six-month interim safety and biomarker results from PRECISE-AD, the Phase 1b trial of its lead drug candidate, PMN310, in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease. In the blinded interim analysis evaluating 136 Alzheimer’s disease patients, PMN310 was observed to have a favorable safety profile across all genotypes, with no cases of amyloid-related imaging abnormalities-edema (ARIA-E) reported as of the data cutoff date, and early, directionally consistent movement in disease-relevant biomarkers potentially reflective of the randomization pattern. The trial remains blinded and ongoing with topline 12-month results expected in the first quarter of 2027. No ARIA-E observed across all genotypes, including APOE4 homozygotes. ARIA-H tracking background rates. Early biomarker movement consistent with target engagement. 12-month topline results expected in the first quarter of 2027. Favorable safety profile across all genotypes: No ARIA-E and 4.4% total ARIA (all mild and asymptomatic, consisting of only amyloid-related imaging abnormalities-microhemorrhages (ARIA-H)), with no treatment-related serious adverse events and no drug-related discontinuations at the interim. Same profile in high-risk APOE4 carriers: No ARIA-E observed in any genotype in a population that included 61% APOE4 carriers, of which 11% were homozygotes. Early biomarker movement consistent with target engagement: On a blinded basis, a majority of patients showed reductions in disease-relevant biomarkers against expected increases in natural-history trajectories: 68.5% of patients had a decline from baseline (change = 0) in plasma pTau217 and 62.5% had a decline in CSF MTBR-tau243, consistent with a potential beneficial drug effect and potentially reflective of the trial’s 3:1 active-to-placebo randomization. These are blinded interim biomarker observations, meaning treatment allocations between drug and placebo groups are not known at this time. These observed biomarker trends are not a determination of efficacy, and trends in biomarkers may not ultimately be reflective of clinical effects. Differentiated, oligomer-selective mechanism: PMN310 is designed to selectively bind toxic amyloid-beta oligomers while avoiding plaque, a mechanism intended to decouple potential efficacy from ARIA risk. Clear path forward: Unblinded 12-month topline data expected in the first quarter of 2027, including efficacy data. PMN310, ProMIS’ lead product candidate for the treatment of Alzheimer’s disease, is a humanized IgG1 monoclonal antibody designed to selectively target only the toxic oligomers of amyloid-beta (AßOs), believed to be among the earliest and most damaging drivers of Alzheimer’s disease, while avoiding binding to amyloid plaques and vascular deposits. This selectivity may reduce or eliminate the risk of amyloid-related imaging abnormalities (ARIA), including brain swelling (ARIA-E) and microhemorrhages (ARIA-H), which are commonly associated with plaque-binding antibodies. PMN310 was granted Fast Track Designation by the U.S. Food and Drug Administration in July 2025. Based on encouraging results from a Phase 1a trial (NCT06105528) in healthy volunteers, ProMIS initiated the PRECISE-AD Phase 1b trial to evaluate PMN310 in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease. PRECISE-AD (NCT06750432) is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of multiple ascending doses (5, 10, and 20 mg/kg) of intravenous PMN310. The study has completed enrollment of 144 participants across the three dosing cohorts who are being treated for twelve months. It is designed to provide meaningful insight into the effects of PMN310 on biomarkers and clinical outcomes. Tillkännagivande • Jul 14
ProMIS Neurosciences Reports First Human Evidence Of Amyloid-Beta Oligomer Target Engagement By PMN310 At AAIC ProMIS Neurosciences Inc. announced the first human evidence of dose-dependent amyloid-beta oligomer (AßO) reduction by its lead Alzheimer’s drug candidate, PMN310, presented at AAIC 2026. The findings, drawn from analysis of samples collected during the Company's Phase 1a trial in healthy volunteers (NCT06105528), showed that individuals receiving PMN310 exhibited a dose-dependent reduction in detectable AßO in cerebrospinal fluid (CSF) at both three and 29 days after dosing. While healthy individuals carry lower oligomer burdens than Alzheimer's patients, amyloid-beta oligomers are detectable in CSF even in cognitively normal adults, making this a meaningful measure of target engagement. This represents one of the first quantitative demonstrations of treatment-related oligomer reduction in humans. Using CSF samples from our Phase 1a study, subjects receiving PMN310 showed a clear dose-dependent reduction in oligomer particles, which, we believe, represents direct evidence that PMN310 was able to reach the brain and engage its intended target. The company intends to deploy this assay in its ongoing PRECISE-AD Phase 1b trial to directly measure oligomer burden in Alzheimer's patients before and after treatment. A large body of evidence in Alzheimer's disease research indicates that disease pathogenesis is not directly driven by plaque burden, but rather by soluble toxic amyloid-beta oligomers. Selectively targeting oligomers while avoiding plaque could have a meaningful impact on both the efficacy and safety of treatment, reducing off-target binding that limits effective dosing and potentially limiting the ARIA side effects associated with plaque-binding antibodies. The data presented provide pharmacodynamic evidence supportive of PMN310's differentiated mechanism of action. The interim analysis will focus on blinded aggregate safety data and overall trends in selected biomarkers across study participants. Top line unblinded results are expected in early First Quarter 2027. Amyloid-beta oligomers in CSF were measured using surface-based fluorescence intensity distribution analysis (sFIDA) developed by attyloid GmbH, an assay which enables direct quantification of oligomer particles with unprecedented sensitivity. While the assay is currently exploratory, it provides pharmacodynamic evidence of target engagement by PMN310. Oligomer reduction: Placebo-treated healthy volunteers (N=40) in the Phase 1a trial exhibited low levels of AßO in CSF. PMN310 administration resulted in a dose-dependent reduction in detectable AßO particles in CSF. Strict oligomer selectivity: PMN310 demonstrated strong binding to AßO with no interaction with monomers by surface plasmon resonance (SPR), and no detectable reactivity with plaques or vascular deposits of Aß in AD brain tissue sections, representing the potential for a differentiated clinical profile. Favorable pharmacokinetics and tolerability: PMN310 was generally well-tolerated, with CSF concentrations linearly dose-dependent, reaching 100–600 times the estimated molar concentration of AßO, and a CSF half-life of approximately 27 days. Preclinical memory preservation: In a transgenic AD mouse model, PMN310 preserved memory and learning performance in the Morris Water Maze task. PMN310, ProMIS’ lead product candidate for the treatment of AD, is a humanized IgG1 monoclonal antibody designed to selectively target only the toxic oligomers of amyloid-beta (AßOs), believed to be among the earliest and most damaging drivers of Alzheimer's disease, while avoiding binding to amyloid plaques and vascular deposits. This selectivity may reduce or eliminate the risk of amyloid-related imaging abnormalities (ARIA), including brain swelling (ARIA-E) and microhemorrhages (ARIA-H), which are commonly associated with plaque-binding antibodies. PMN310 was granted Fast Track Designation by the U.S. Food and Drug Administration in July 2025. Based on encouraging results from a Phase 1a trial (NCT06105528) in healthy volunteers, ProMIS initiated the PRECISE-AD Phase 1b trial to evaluate PMN310 in patients with mild cognitive impairment due to AD or mild AD. PRECISE-AD (NCT06750432) is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of multiple ascending doses (5, 10, and 20 mg/kg) of intravenous PMN310. The study has completed enrollment of 144 participants across the three dosing cohorts who are being treated for twelve months. It is designed to provide meaningful insight into the effects of PMN310 on biomarkers and clinical outcomes. Tillkännagivande • Apr 10
ProMIS Neurosciences, Inc., Annual General Meeting, May 20, 2026 ProMIS Neurosciences, Inc., Annual General Meeting, May 20, 2026. New Risk • Nov 28
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$623.1k This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$28m free cash flow). Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (65% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$623.1k market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$51m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). New Risk • Nov 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$28m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$28m free cash flow). Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (65% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$51m net loss in 3 years). Market cap is less than US$100m (US$21.0m market cap). 
