ProMIS Neurosciences (PMN) - 2025 Q2 - Quarterly Results

Executive Summary & Recent Developments Company Overview ProMIS Neurosciences Inc. is a clinical-stage biotechnology company focused on developing antibody therapies for misfolded toxic proteins in neurodegenerative diseases, including Alzheimer's, ALS, and Parkinson's disease - ProMIS Neurosciences Inc. is a clinical-stage biotechnology company focused on generating and developing antibody therapies for misfolded toxic proteins in neurodegenerative diseases such as Alzheimer's disease, amyotrophic lateral sclerosis, and Parkinson's disease[1] Key Corporate Highlights ProMIS Neurosciences achieved significant progress in Q2 2025 and July, including PMN310's FDA Fast Track designation, over 50% patient enrollment in PRECISE-AD Phase 1b trial with good safety, and strengthened financial position through financing - The US FDA granted Fast Track designation for PMN310 in Alzheimer's disease, enhancing its potential for priority review[1][2] - The PRECISE-AD Phase 1b Alzheimer's disease trial is on track, with over 50% patient enrollment and no ARIA cases or patient withdrawals observed to date, reinforcing PMN310's potentially favorable safety profile[1][2] - Financing in July 2025 generated $21.6 million in gross proceeds, strengthening the financial position[1][2] Research & Development Programs EpiSelect™ Drug Discovery Engine ProMIS's proprietary EpiSelect™ platform identifies uniquely exposed conformational epitopes on toxic misfolded proteins, generating highly selective antibodies or vaccine formulations to avoid off-target effects, successfully applied to PMN310 and candidates for α-synuclein and TDP-43 - EpiSelect™ is a computational platform used to identify uniquely exposed conformational epitopes on toxic misfolded proteins, enabling the generation of misfolding-specific antibody or vaccine formulations[3] - The platform generated PMN310, a clinical-stage humanized monoclonal antibody candidate, highly selective for toxic amyloid-beta oligomers (AβO) with no significant reactivity to amyloid-beta monomers or fibrils, thereby avoiding off-target effects and reducing the risk of ARIA (brain edema and microhemorrhages)[3] - Specific epitopes for α-synuclein toxic oligomers/soluble fibrils driving synucleinopathies, and for pathogenic TDP-43 in ALS/FTD, have been identified, with lead antibody candidates generated[3][4] Alzheimer's Disease Program (PMN310) PMN310 is ProMIS's lead candidate for Alzheimer's disease, a humanized IgG1 antibody designed to selectively target toxic AβO, aiming to reduce ARIA risk and enhance efficacy, with significant progress in clinical trials and regulatory milestones - PMN310 is the company's lead candidate for AD, a potential best-in-class humanized monoclonal antibody designed to selectively target toxic oligomers while avoiding plaques, potentially reducing or eliminating ARIA risk and improving safety[10] PRECISE-AD Phase 1b Trial Progress & Safety The PRECISE-AD Phase 1b Alzheimer's trial is progressing well, with over 50% patient enrollment and no ARIA cases or withdrawals reported to date, demonstrating PMN310's favorable safety profile; the DSMB recommended continuing the trial and advancing to the next dose level - As of August 12, 2025, the PRECISE-AD Phase 1b Alzheimer's disease trial has enrolled over 50% of the planned 128 patients[2][5] - No amyloid-related imaging abnormalities (ARIA) cases, including brain edema or microhemorrhages, or patient withdrawals have been observed to date[2][5] - In May 2025, the DSMB recommended the trial continue as planned without modifications and approved advancing from the first cohort's 5mg/kg dose to the second cohort's 10mg/kg dose[5] Regulatory Milestones & Biomarker Insights PMN310 received FDA Fast Track designation in July 2025; studies indicate plasma pT217 or pT181 as biomarkers have three times the effect size of clinical outcome CDR-SB, suggesting higher trial power or smaller sample sizes; 6-month blinded interim results for PMN310 are expected in Q2 2026, with final topline results in Q4 2026 - In July 2025, PMN310 received FDA Fast Track designation[2][5][10] Biomarker vs. Clinical Outcome Effect Size Comparison | Metric | Cohen's d Effect Size | | :------------------- | :------------------- | | Plasma pT217 or pT181 | Three times that of clinical outcome CDR-SB | | Clinical Outcome CDR-SB | Baseline | - The group-level correlation between plasma pT217 or pT181 and clinical outcome CDR-SB is approximately 0.786, with a p-value of 0.036[12] - ProMIS expects to report 6-month blinded interim results for PRECISE-AD in Q2 2026, with topline results anticipated in Q4 2026[2][12] Alzheimer's Disease Vaccine Program (PMN311) ProMIS is advancing the development of its PMN311 Aβ vaccine program for Alzheimer's disease, based on its oligomer-targeting epitopes - ProMIS continues to advance its PMN311 Aβ vaccine program in AD, based on its oligomer-targeting epitopes[6] Other Neurodegenerative Disease Programs ProMIS is developing candidates for Parkinson's disease, Multiple System Atrophy, and Amyotrophic Lateral Sclerosis, with PMN442 and PMN267 ready for IND-enabling studies Parkinson's Disease and Multiple System Atrophy (PMN442) PMN442 is ProMIS's lead candidate for Parkinson's disease, Multiple System Atrophy, and other synucleinopathies, a humanized IgG1 antibody with selective binding and protective activity against pathogenic α-synuclein, ready for IND-enabling studies - PMN442 is ProMIS's lead candidate for PD, MSA, and other synucleinopathies, a humanized IgG1 antibody based on its selective binding and protective activity against pathogenic α-synuclein[7] - PMN442 is ready for IND-enabling studies[7] Amyotrophic Lateral Sclerosis (PMN267) PMN267 is a humanized IgG1 antibody targeting toxic misfolded TDP-43, considered a potential therapeutic target for ALS, and is currently ready for IND-enabling studies - PMN267 is a humanized IgG1 antibody targeting toxic misfolded TDP-43, a potential therapeutic target for ALS[12] - PMN267 is ready for IND-enabling studies[12] Financial Performance Second Quarter 2025 Financial Highlights ProMIS saw significant year-over-year increases in Q2 2025 R&D expenses and net loss, primarily due to PRECISE-AD Phase 1b trial expenditures, while raising $21.6 million in gross proceeds through multiple transactions in July 2025, substantially strengthening its cash position Key Financial Data for Q2 2025 (Year-over-Year) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :------------------- | :---------- | :---------- | :----------- | | Cash and Cash Equivalents | $4.5 million | $1.0 million | +$3.5 million | | Research and Development Expenses | $8.7 million | $1.6 million | +$7.1 million | | General and Administrative Expenses | $1.4 million | $1.1 million | +$0.3 million | | Net Loss | $(10.1) million | $(2.6) million | $(7.5) million | - The net loss was primarily attributable to increased expenditures for the PMN310 PRECISE-AD Phase 1b trial[13] - In July 2025, ProMIS obtained $21.6 million in gross proceeds through a registered direct offering, private placement, and warrant exercises[2][13] Consolidated Balance Sheets As of June 30, 2025, ProMIS's total assets and cash balance significantly decreased from December 31, 2024, while total liabilities substantially increased, resulting in a negative total shareholders' (deficit) equity, reflecting changes in financial position due to clinical trial investments and operating losses Selected Consolidated Balance Sheet Items (As of June 30, 2025 vs. December 31, 2024) | Item | June 30, 2025 | December 31, 2024 | Change | | :--------------------------- | :------------ | :----------- | :------- | | Cash | $4,510,119 | $13,291,167 | $(8,781,048) | | Total Current Assets | $9,509,496 | $18,911,456 | $(9,401,960) | | Total Current Liabilities | $9,824,087 | $2,218,425 | +$7,605,662 | | Total Liabilities | $9,892,074 | $2,423,280 | +$7,468,794 | | Accumulated Deficit | $(108,152,005) | $(90,687,073) | $(17,464,932) | | Total Shareholders' (Deficit) Equity | $(382,578) | $16,488,176 | $(16,870,754) | Consolidated Statements of Operations In Q2 and H1 2025, ProMIS's R&D and total operating expenses significantly increased year-over-year, leading to a substantial expansion in net loss and net loss per share, primarily reflecting increased investment in clinical trials Selected Consolidated Statements of Operations Items (Q2 2025 vs. Q2 2024) | Item | Q2 2025 | Q2 2024 | YoY Change | | :--------------------------- | :---------- | :---------- | :----------- | | Research and Development Expenses | $8,749,784 | $1,625,821 | +$7,123,963 | | General and Administrative Expenses | $1,434,877 | $1,087,885 | +$346,992 | | Total Operating Expenses | $10,184,661 | $2,713,706 | +$7,470,955 | | Net Loss | $(10,117,029) | $(2,623,657) | $(7,493,372) | | Net Loss Per Share (Basic and Diluted) | $(0.29) | $(0.13) | $(0.16) | Selected Consolidated Statements of Operations Items (Six Months Ended June 30, 2025 vs. Six Months Ended June 30, 2024) | Item | H1 2025 | H1 2024 | YoY Change | | :--------------------------- | :---------- | :---------- | :----------- | | Research and Development Expenses | $14,214,034 | $3,749,599 | +$10,464,435 | | General and Administrative Expenses | $3,430,723 | $2,640,758 | +$789,965 | | Total Operating Expenses | $17,644,757 | $6,390,357 | +$11,254,400 | | Net Loss | $(17,464,932) | $(6,258,745) | $(11,206,187) | | Net Loss Per Share (Basic and Diluted) | $(0.50) | $(0.32) | $(0.18) | Company and Product Information About ProMIS Neurosciences Inc. ProMIS Neurosciences is a clinical-stage biotechnology company dedicated to discovering and developing therapeutic antibodies and vaccines targeting toxic oligomers in neurodegenerative and other misfolded protein diseases, utilizing its proprietary EpiSelect™ target discovery engine to identify disease-specific epitopes - ProMIS Neurosciences is a clinical-stage biotechnology company focused on discovering and developing therapeutic antibodies and vaccines targeting toxic oligomers in neurodegenerative and other misfolded protein diseases[9] - The company's proprietary target discovery engine, EpiSelect™, has been shown to predict novel disease-specific epitopes (DSEs) on the surface of misfolded protein molecules that cause neurodegenerative and other misfolded protein diseases, including AD, ALS, FTD, MSA, and PD[9] About PMN310 PMN310 is ProMIS's lead candidate for Alzheimer's disease, a potential best-in-class humanized monoclonal antibody designed to selectively target toxic oligomers while avoiding plaques, potentially reducing or eliminating ARIA risk and improving safety; PMN310 received FDA Fast Track designation in July 2025 - PMN310 is the company's lead candidate for AD, a potential best-in-class humanized monoclonal antibody designed to selectively target toxic oligomers while avoiding plaques, potentially reducing or eliminating ARIA risk and improving safety[10] - PMN310 received FDA Fast Track designation in July 2025[10] Forward-Looking Statements Forward-Looking Statements This press release contains forward-looking statements regarding future events, expectations, and projections, including clinical trial results, pipeline progress, and financial outlook; these statements are based on management's current expectations, assumptions, and estimates, but are subject to known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from forward-looking information, particularly that preclinical or early clinical results may not be indicative, and regarding the company's ability to continue as a going concern - This press release contains forward-looking information regarding the company's Phase 1b study in AD patients and expected results (including interim results in H1 2026 and topline results by end of 2026), potential benefits of PMN310, pipeline progress, timing of IND-enabling studies, future financial results, and ability to continue as a going concern[11][14] - Forward-looking information is necessarily based on a number of opinions, assumptions, and estimates that, while considered reasonable by the company as of the date of the press release, are subject to known and unknown risks, uncertainties, and other factors that may cause the actual results, level of activity, performance, or achievements to be materially different from those expressed or implied by such forward-looking information[14] - Important factors that could cause actual results to differ materially from forward-looking information include that preclinical or early clinical results may not be indicative, the company's ability to fund its operations and continue as a going concern, and its accumulated deficit and expectation of ongoing losses[14] Contact Information Contact Information This section provides contact details for ProMIS Neurosciences, including the company website, media inquiries email, and investor relations contact - Company Website: **www.promisneurosciences.com**[15](index=15&type=chunk) - Media Inquiries: info@promisneurosciences.com[15] - Investor Relations Contact: Kaytee Bock Zafereo (katherine.bock@promisneurosciences.com)[15]