PMN310 / ProMIS Neurosci - LARVOL DELTA

PRECISE-AD is a randomized, double-blind, placebo-controlled Phase 1b trial evaluating PMN310 in patients with mild cognitive impairment due to early AD. (GlobeNewswire) - "The trial remains blinded and ongoing. The Company expects all patients to complete 12-month dosing by the fourth quarter of 2026 and, following database lock and statistical analysis, to report unblinded 12-month topline data, including the full safety dataset, an expanded biomarker panel, and clinical cognitive outcome measures, in the first quarter of 2027."

P1 data • Trial status • Alzheimer's Disease

ProMIS Neurosciences Reports Positive Blinded Six-Month Interim Safety and Biomarker Data for PMN310 in the PRECISE-AD Phase 1b Alzheimer’s Disease Trial (GlobeNewswire) - "Favorable safety profile across all genotypes...No ARIA-E observed in any genotype in a population that included 61% APOE4 carriers, of which 11% were homozygotes, a group underserved by approved amyloid-directed therapies...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...'We look forward to our 12-month topline readout in the first quarter of 2027.'"

P1 data • Alzheimer's Disease

ProMIS Neurosciences Reports First Human Evidence of Amyloid-Beta Oligomer Target Engagement by PMN310 at AAIC 2026 (GlobeNewswire) - "'Top line unblinded results are expected in early Q1 2027.'...Oligomer reduction: Placebo-treated healthy volunteers (N=40) in the Phase 1a trial exhibited low levels of AβO in CSF. PMN310 administration resulted in a dose-dependent reduction in detectable AβO particles in CSF; Strict oligomer selectivity: PMN310 demonstrated strong binding to AβO with no interaction with monomers by surface plasmon resonance (SPR), and no detectable reactivity with plaques or vascular deposits of Aβ in AD brain tissue sections, representing the potential for a differentiated clinical profile; Favorable pharmacokinetics and tolerability: PMN310 was generally well-tolerated...In a transgenic AD mouse model, PMN310 preserved memory and learning performance in the Morris Water Maze task."

P1 data • Alzheimer's Disease

Activity And Clinical Progress Of Pmn310 Designed To Selectively Target Toxic aß Oligomers For Greater Potency In Alzheimer's Disease (AAIC 2026) - No abstract available

Clinical • Alzheimer's Disease • CNS Disorders

Company closed PIPE financing with gross proceeds of up to $175 million, including the possible exercise of warrants, from long-term global investors. (GlobeNewswire) - "Proceeds are expected to fund the Company through 2027, including completion of the ongoing Phase 1b clinical trial in Alzheimer's disease (AD)."

Financing • Alzheimer's Disease

Alzheimer’s Disease (AD) Program (PMN310) (GlobeNewswire) - "A blinded interim analysis is anticipated in early third quarter 2026, providing a mid‑study review of aggregated safety data and overall biomarker trends across all participants. As this analysis remains blinded, individual treatment assignments will not be disclosed, and results will represent combined data from both active and placebo groups...Full patient dosing is expected to be completed by year‑end 2026, with unblinded top‑line results anticipated in early 2027. At that time, the Company expects to evaluate biomarker outcomes and clinical measures by treatment group, providing a comprehensive understanding of PMN310’s potential in Alzheimer’s disease...Alzheimer’s Association International Conference (AAIC): Poster presentation....will be presented by Johanne Kaplan, Chief Development Officer."

P1 data • Trial status • Alzheimer's Disease

Alzheimer’s Disease (AD) Program (PMN310) (GlobeNewswire) - "Based on current clinical trial patient visit schedules, the Company expects to complete the six-month assessments in the second quarter of 2026. The blinded interim analysis is anticipated in early third quarter 2026. Completion of all patient visits is expected in the fourth quarter of 2026, with top-line data anticipated in early 2027 following database lock and statistical analysis...The Data and Safety Monitoring Board recommended advancement to cohort 3, the study’s highest planned dose level, with no safety concerns identified; Completed enrollment of 144 participants in PRECISE-AD Phase 1b trial."

P1 data • Trial status • Alzheimer's Disease

Drug Development. (PubMed, Alzheimers Dement) - P1 | "PRECISE-AD will be the first study to examine the effects of a monoclonal antibody directed solely against AβO on biomarkers associated with AD pathology and clinical outcomes."

Journal • Alzheimer's Disease • CNS Disorders • Aβ42 • GFAP

Drug Development. (PubMed, Alzheimers Dement) - "ProMIS has circumvented the specificity limitations of conventional immunizations to enable selective passive and active immunotherapies for neurodegenerative diseases."

Journal • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • Hematological Disorders • Movement Disorders • Parkinson's Disease • TARDBP

PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD) (clinicaltrials.gov) - P1 | N=144 | Active, not recruiting | Sponsor: ProMis Neurosciences, Inc | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2026 ➔ Dec 2026

Enrollment closed • Trial primary completion date • Alzheimer's Disease • CNS Disorders

PMN310 Is Positioned to Test the Oligomer Hypothesis Without Confounding Cross-Reactivity (GlobeNewswire) - "All other antibodies tested in the study appeared to bind monomers and/or plaque to varying degrees. PMN310 was the only antibody in the study showing strict specificity for toxic soluble oligomers while avoiding monomers and plaque; This positions the ongoing PRECISE-AD study to potentially become the first clinical test of oligomer-only targeting, which may clarify the relative contributions of oligomers vs plaque to cognitive decline, an important scientific inflection point for the field."

Trial status • Alzheimer's Disease

Key Findings and Implications for PMN310: Antibody Specificity for Toxic Oligomers May Provide Greater Potency (GlobeNewswire) - "In the studies conducted, clinical efficacy across Aβ antibodies correlated strongly with the ability to bind toxic oligomers even in the presence of overwhelming monomer concentrations, which otherwise divert antibody activity away from pathogenic species; PMN310 showed the highest resistance to monomer competition among all antibodies tested, preserving oligomer binding while pan-Aβ antibodies lost activity in in vitro models. This suggests that a higher proportion of each dose of PMN310 could be available to reach the relevant toxic targets, which could potentially translate into clinical benefit in patients; In AD mouse studies, this oligomer selectivity translated into complete protection of spatial memory, restoring performance to normal wild-type levels, reinforcing the mechanistic rationale."

Preclinical • Alzheimer's Disease

PMN310’s Lack of Plaque or Vascular Deposit Binding Suggests a Possible Lower Risk of ARIA (GlobeNewswire) - "ARIA is strongly associated with antibody binding to insoluble plaque and vascular amyloid deposits. Antibodies such as donanemab, aducanumab, and lecanemab showed significant plaque binding and correspondingly increased ARIA rates. In contrast, PMN310 exhibited no detectable plaque binding across concentrations tested, aligning with its engineered specificity for misfolded, soluble oligomers, not fibrils; Consistent with this mechanism, high-dose chronic administration of PMN310 in plaque-bearing mice (800 mg/kg for 26 weeks) produced no microhemorrhages on microscopic examination of brain tissue; Together, these findings provide preclinical evidence supporting a possible reduced ARIA risk."

Preclinical • Alzheimer's Disease

Implications for ProMIS, PMN310, and the PRECISE-AD Trial (GlobeNewswire) - "The newly published analysis is directly aligned with, and supportive of, key elements of the PRECISE-AD design: Biomarker-centric strategy: PRECISE-AD incorporates plasma pTau (including pTau217) as a central biomarker endpoint at 6 and 12 months, consistent with the timing and methodology highlighted in the publication; Early readout with potentially predictive value: By assessing plasma pTau changes as early as 6 months, PRECISE-AD is positioned to generate an early, quantitative signal of disease modification that can be used to model and predict future clinical outcomes....'Importantly, we remain on track to assess blinded 6-month biomarker data, including plasma pTau217, from our PRECISE-AD trial in Q2 2026.'"

P1 data • Trial status • Alzheimer's Disease • Tauopathies And Synucleinopathies

Relationship between efficacy and preferential targeting of soluble Aβ aggregates. (PubMed, Alzheimers Dement (N Y)) - "These results suggest that selectivity for soluble toxic oligomers correlates with clinical efficacy, potentially attenuating monomer competition and amyloid-related imaging abnormalities (ARIA)."

Journal • Alzheimer's Disease • CNS Disorders • Hematological Disorders

Alzheimer’s Disease Program (PMN310) (GlobeNewswire) - "On track to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026....As of November 12, 2025, ProMIS has fully enrolled Cohorts 1 and 2 and is well into Cohort 3, with complete enrollment expected before the end of the year. PMN310 continues to demonstrate a favorable safety profile, with respect to incidence of amyloid-related imaging abnormalities (ARIA) and serious adverse events (SAEs)."

P1 data • Trial status • Alzheimer's Disease

ProMIS Neurosciences Receives DSMB Approval to Advance to Final Dose Escalation Cohort in Phase 1b Alzheimer’s Trial of PMN310 (GlobeNewswire) - "The recommendation followed a review of available safety data through Cohort 2, which has now been fully enrolled, with no cases of amyloid-related imaging abnormalities (ARIA) observed to date. Enrollment of patients into Cohort 3 is now underway, keeping the Company on track to deliver 6-month interim data in the second quarter of 2026 and final 12-month top-line results in the fourth quarter of 2026."

DSMB • P1 data • Alzheimer's Disease

ProMIS Neurosciences to Showcase Protein-Misfolding Drug Discovery Platform & PRECISE-AD Trial Design at the 2025 Alzheimer’s Association International Conference (GlobeNewswire) - "ProMIS...announced it has been invited to present an overview of its ongoing PRECISE-AD trial in Alzheimer’s Disease (AD) and its proprietary Discovery Platform, EpiSelect, at the Alzheimer’s Association International Conference 2025 (AAIC) taking place in Toronto, Canada from July 27-31, 2025...'As of this week, more than 50% of the approximately 128 patients planned for the study have been enrolled, reflecting the pace of our clinical progress and the urgent need for new treatment options. To date, we have not observed any cases of amyloid-related imaging abnormalities (ARIA), including brain swelling or microhemorrhages...We anticipate reporting six-month interim data from the study in the second quarter of 2026, with topline results expected by the fourth quarter of 2026.'"

Diagnostic • P1 data • Trial status • Alzheimer's Disease

Alzheimer’s Disease Program (PMN310) (GlobeNewswire) - "As of August 12, 2025, ProMIS has enrolled over 50% of the planned 128 patients in the PRECISE-AD Phase 1b Alzheimer’s disease trial. No cases of ARIA, including brain swelling or microhemorrhage, have been observed to date and no patient dropouts have been reported....ProMIS expects to report blinded six-month interim results from PRECISE-AD in 2Q 2026, with topline results anticipated in 4Q 2026. The six-month interim analysis will include biomarker and safety data (including incidence of ARIA), with final analysis to include clinical outcome measures."

Enrollment status • P1 data • Alzheimer's Disease

ProMIS Neurosciences Granted Fast Track Designation by U.S. FDA for PMN310 in the Treatment of Alzheimer’s Disease (The Manila Times) - "ProMIS Neurosciences Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PMN310, the Company’s lead therapeutic candidate in development for the treatment of Alzheimer’s disease...The ongoing PRECISE-AD Phase 1b trial is evaluating PMN310 in patients with early AD. The study is focused on characterizing safety, tolerability, pharmacokinetics, and disease-relevant biomarkers. ProMIS anticipates reporting interim six-month biomarker and safety data in Q2 ‘26 and final results in Q4 ‘26."

Fast track • P1 data • Alzheimer's Disease

ProMIS Neurosciences Announces First Quarter 2025 Financial Results (GlobeNewswire) - "Alzheimer’s Disease Program (PMN310): ProMIS expects to report six-month interim results from PRECISE-AD in the first half of 2026, with topline results anticipated by the end of 2026. We anticipate the six-month interim analysis will include impact of biomarkers and safety (including incidence of ARIA), with final analysis to include clinical outcome measures."

P1 data • Alzheimer's Disease

ProMIS Neurosciences Announces First Quarter 2025 Financial Results (GlobeNewswire) - "Research and development expenses were $5.5 million for the first quarter ended March 31, 2025, compared to $2.1 million for the same period in 2024. The increase was primarily attributable to costs related to the execution of the PMN310 Phase 1b clinical trial."

Commercial • Alzheimer's Disease

RATIONAL DESIGN OF ALZHEIMER'S VACCINE TO MAXIMIZE SELECTIVE TARGETING OF TOXIC AMYLOID -BETA OLIGOMERS (ADPD 2025) - "Maximal reactivity was observed w ith immune IgG against a single epitope (peptide 301), the target of PMN310, our clinical -stage monoclonal antibody... Vaccination with oligomer -restricted conformational B cell epitopes conjugated to KLH produced strong antibody responses with no measurable pro -inflammatory T cell responses against Abeta. Immunization with epitope 301 alone was sufficient to produce maxim al reactivity against brain oligomers."

Alzheimer's Disease • CNS Disorders • Inflammation

ProMIS Neurosciences Showcases Preclinical Data on Platform Derived Vaccines for Neurodegenerative Diseases at the American Academy of Neurology 2025 Annual Meeting (GlobeNewswire) - "ProMIS Neurosciences Inc...today announced that the Company will present preclinical data on computationally-derived vaccines for neurodegenerative diseases at the American Academy of Neurology (AAN) Annual Meeting taking place from April 5-9, 2025 in San Diego...Results from the preclinical study showed that immunization with a single conformational epitope, peptide 301, the target of PMN310 antibody, was sufficient to produce maximal reactivity against AD brain oligomers...Results from the preclinical study showed that vaccination with conformational B cell epitopes produced high affinity antibodies with the desired selectivity for pathogenic ASyn and identified optimal vaccine configurations for further development."

Preclinical • Alzheimer's Disease • CNS Disorders • Dementia

Novel Approach to Optimization of Alzheimer's Vaccine Configuration for Maximal Targeting of Toxic Amyloid-Beta Oligomers (AAN 2025) - "Maximal reactivity was observed with immune IgG against a single epitope (peptide 301), the target of PMN310, our clinical-stage monoclonal antibody. Vaccination with oligomer-restricted conformational B cell epitopes conjugated to KLH produced strong antibody responses with no measurable pro-inflammatory T cell responses against Abeta. Immunization with epitope 301 alone was sufficient to produce maximal reactivity against brain oligomers."

Alzheimer's Disease • CNS Disorders • Inflammation