Core Insights - ProMIS Neurosciences Inc. has entered into a securities purchase agreement to raise approximately $175 million through the issuance of common shares and warrants, aimed at extending its cash runway into 2028 and supporting key clinical milestones in Alzheimer's disease research [1][4] Financing Details - The financing includes the sale of 6,815,296 common shares at $10.77 each, 100,000 pre-funded warrants at a similar price with a minimal exercise price, and 725,221 common shares sold at $12.13 to affiliates and insiders [2] - The common share warrants have an exercise price of $14.40, are immediately exercisable, and will expire within 60 days of a defined milestone event or on February 3, 2031 [2] - The anticipated upfront gross proceeds from the financing are approximately $75 million, with potential additional proceeds of up to $100 million if all warrants are exercised [4] Investor Participation - The private investment in public equity (PIPE) financing is co-led by Janus Henderson and Ally Bridge Group, with participation from various institutional investors including Deep Track Capital and Wellington Management [3] Clinical Development Plans - ProMIS aims to use the proceeds to complete its Phase 1b clinical study for Alzheimer's disease and to accelerate the development of a subcutaneous formulation of PMN310, with blinded top-line data expected in mid-2026 and 12-month data by the end of 2026 [4]

Core Insights - Several small-cap biotech and healthcare companies experienced notable gains in after-hours trading, driven by recent corporate updates and clinical milestones Company Updates - Inspira Technologies Oxy B.H.N. Ltd. (IINN) rose 5.88% to $1.08 following a recent definitive agreement for a registered direct offering of its ordinary shares and a Standby Equity Purchase Agreement with YA II PN, Ltd. [2] - Galectin Therapeutics Inc. (GALT) increased by 1.79% to close at $6.27, despite no new corporate developments reported [3] - MediciNova, Inc. (MNOV) advanced 4.83% to $1.52 after successfully completing patient enrollment in its Phase 2 OXTOX study, evaluating MN-166 for chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients [4] - Marker Therapeutics, Inc. (MRKR) gained 5.56% to $1.33 without any new company-specific announcements [5] - Sharps Technology, Inc. (STSS) climbed nearly 4% to $2.09, also without fresh updates [6] - DiaMedica Therapeutics Inc. (DMAC) rose 2.89% to $8.55 after a productive pre-IND meeting with the FDA regarding its planned study of DM199 in preeclampsia [6] - Corbus Pharmaceuticals Holdings, Inc. (CRBP) edged higher by 1.36% to $8.21, following the completion of its Phase 1a study of CRB-913 and initiation of the Phase 1b CANYON-1 trial [7] - ProMIS Neurosciences, Inc. (PMN) added 0.83% to $8.49, recovering slightly after a decline earlier in the day, with the completion of enrollment of 144 patients in its PRECISE-AD Phase 1b clinical trial for Alzheimer's disease [8]

Core Insights - ProMIS Neurosciences Inc. has completed enrollment of 144 patients in its PRECISE-AD Phase 1b clinical trial for PMN310, targeting early Alzheimer's disease [1][4] - The trial is designed to provide clinically and biologically meaningful insights, with interim data expected in Q2 2026 and final results in Q4 2026 [1][3] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing antibody therapeutics and vaccines for neurodegenerative diseases, including Alzheimer's disease, ALS, and Parkinson's disease [1][5] - The company utilizes its proprietary EpiSelect™ technology to identify Disease Specific Epitopes (DSEs) on misfolded proteins [5] Clinical Trial Details - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics, and clinical effects of PMN310, which selectively targets toxic soluble amyloid-beta oligomers [2][8] - PMN310 has shown a favorable safety profile with no treatment-related serious adverse events reported and minimal patient discontinuations [3][4] Future Expectations - The upcoming blinded 6-month interim analysis in Q2 2026 will evaluate key biomarkers, followed by a final unblinded top-line analysis expected in Q4 2026 [3][8] - The trial's design aims to provide sufficient power to detect effects on biomarkers and clinical outcomes, with a focus on reducing amyloid-related imaging abnormalities (ARIA) [8]

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 ...

Core Insights - ProMIS Neurosciences Inc. is advancing its clinical-stage biotechnology efforts with a focus on antibody therapeutics targeting neurodegenerative diseases, particularly Alzheimer's disease (AD) [1][8] - Recent analysis indicates that plasma phosphorylated tau (pTau181 and pTau217) can serve as a significant primary endpoint in early-stage AD clinical trials, potentially predicting clinical benefits [2][3] Group 1: Key Findings from the Publication - The analysis utilized data from several large monoclonal antibody trials in early AD, demonstrating that plasma pTau can effectively predict future clinical outcomes [3] - A strong predictive relationship was found, with treatment effects on plasma pTau at 6 months correlating approximately 0.78 with treatment effects on the Clinical Dementia Rating Sum of Boxes (CDR-SB) at 12 months [5] - The effect size on plasma pTau was about 2.6 times larger than that on CDR-SB, suggesting earlier and more robust detection of biomarker changes compared to clinical changes [5] Group 2: Implications for ProMIS and the PRECISE-AD Trial - ProMIS is conducting the PRECISE-AD trial, a Phase 1b study of PMN310, its lead amyloid-beta targeting antibody, in early AD patients [4][10] - The trial design incorporates plasma pTau as a central biomarker endpoint at 6 and 12 months, aligning with the publication's findings [6] - Simulations indicate that trials using plasma pTau as a primary endpoint may require as few as 100 participants, making them smaller and more efficient [5][6] Group 3: Mechanistic Fit for PMN310 - PMN310 is designed to neutralize toxic oligomers upstream of tau phosphorylation, which could lead to meaningful reductions in plasma pTau if successful [7] - The publication validates ProMIS's strategy of using sensitive plasma pTau biomarkers as a central element in the ongoing Phase 1b AD clinical trial [7] - The ability to link early plasma readouts to later clinical benefits allows for more informed decision-making regarding PMN310's development path [7]

Core Viewpoint - ProMIS Neurosciences, Inc. is actively engaging with investors and the healthcare community through participation in the 8th Annual Evercore Healthcare Conference, highlighting its focus on developing innovative therapies for Alzheimer's disease and other neurodegenerative disorders [1][2]. Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company dedicated to discovering and developing therapeutic antibodies and vaccines that target toxic oligomers associated with neurodegenerative diseases, including Alzheimer's disease, ALS, FTD, MSA, and PD [3]. - The company utilizes its proprietary EpiSelect™ target discovery engine to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are crucial for developing targeted therapies [3]. Product Development - PMN310 is the lead product candidate designed as a humanized monoclonal antibody that selectively targets toxic oligomers while avoiding plaque, potentially reducing the risk of amyloid-related imaging abnormalities (ARIA) [4]. - PMN310 received Fast Track designation from the U.S. FDA in July 2025, indicating its potential significance in treating Alzheimer's disease [4]. Clinical Trials - Following positive results from the Phase 1a trial, ProMIS initiated the PRECISE-AD Phase 1b clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PMN310 in patients with Mild Cognitive Impairment and mild Alzheimer's disease [5]. - The PRECISE-AD trial is designed as a randomized, double-blind, placebo-controlled study, focusing on the effects of PMN310 on biomarkers and clinical outcomes associated with Alzheimer's disease [5]. EpiSelect Drug Discovery Engine - The EpiSelect platform enables the identification of conformational epitopes on toxic misfolded proteins, facilitating the development of highly selective therapeutic antibodies and vaccines [6]. - PMN310 has demonstrated high selectivity for toxic amyloid-beta oligomers without significant reactivity with other forms, potentially minimizing adverse effects associated with conventional therapies [6].

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]