ProMIS Neurosciences (PMN) - 2025 Q1 - Quarterly Results

Business and Clinical Highlights ProMIS Neurosciences reported rapid enrollment for its PMN310 PRECISE-AD trial, anticipating 2026 results and emphasizing PMN310's potential for improved safety by avoiding ARIA - The company achieved rapid enrollment for the first cohort in the PRECISE-AD trial for its lead candidate, PMN310, in Alzheimer's disease, which exceeded expectations[2] - Management believes PMN310 could be a best-in-class treatment due to its selective targeting of toxic Aβ oligomers, which may lead to a substantially improved safety profile by avoiding ARIA[2] - A planned interim analysis in the first half of 2026 is expected to provide early insights into PMN310's clinical benefit and tolerability, with full topline results anticipated by the end of 2026[2][4] Clinical Program Updates The company provided updates on its PMN310 Phase 1b PRECISE-AD trial and presented preclinical data for its AD, ALS, and synucleinopathy programs Alzheimer's Disease Program (PMN310) PMN310, an IgG1 antibody targeting toxic Aβ oligomers, is in a Phase 1b trial focused on safety and reduced ARIA risk, with results expected in 2026 - PMN310 is a humanized IgG1 antibody targeting toxic amyloid-beta oligomers (AβO), which are considered a primary driver of Alzheimer's disease[3] - The PRECISE-AD Phase 1b trial is a randomized, double-blind, placebo-controlled study evaluating multiple ascending doses (5, 10, 20 mg/kg) in approximately 128 patients across 22 U.S. sites. The first cohort has completed enrollment[3] - A primary outcome of the study is safety, with a specific focus on assessing the expectation that PMN310 will have a reduced risk of ARIA. The study is powered to provide 95% confidence for ARIA detection[3] - Key trial timeline: Six-month interim results are expected in the first half of 2026, with topline results anticipated by the end of 2026[4] Other Pipeline Programs The company is advancing an AD vaccine, an ALS antibody, and a synucleinopathy vaccine, with preclinical data demonstrating target selectivity and proof-of-concept - The company is advancing an Aβ vaccine program (PMN311) for Alzheimer's, an antibody for ALS (PMN267) targeting misfolded TDP-43, and a vaccine for synucleinopathies (PMN440)[4][5][6] - Preclinical data for the AD vaccine presented at the AD/PD Conference showed that a single conformational epitope was sufficient to produce maximal reactivity against AD brain oligomers[7] - Preclinical data for the synucleinopathy vaccine (PMN440) demonstrated that vaccination with conformational B cell epitopes produced high-affinity antibodies with desired selectivity for pathogenic alpha-synuclein (ASyn), supporting its development for diseases like Parkinson's[7][12] First Quarter 2025 Financial Results The company's financial position reflects increased clinical development spending, with cash decreasing to $8.4 million and net loss widening to $7.3 million due to higher R&D expenses Financial Metric | Financial Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $8.4M | N/A | -$4.9M from Dec 31, 2024 | | Research & Development Expenses | $5.5M | $2.1M | +160% | | General & Administrative Expenses | $2.0M | $1.6M | +25% | | Net Loss | $7.3M | $3.6M | +103% | | Net Loss Per Share | $(0.21) | $(0.19) | +10.5% | Consolidated Financial Statements The consolidated financial statements detail the company's financial position, showing decreased total assets to $13.6 million and a higher net loss from increased clinical trial investment Consolidated Balance Sheets The balance sheet reflects a decrease in cash and total current assets, alongside an increase in total liabilities and a reduction in total shareholders' equity Balance Sheet Item | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash | $8,364,301 | $13,291,167 | | Total current assets | $13,646,671 | $18,911,456 | | Liabilities & Equity | | | | Total current liabilities | $4,056,248 | $2,218,425 | | Total liabilities | $4,174,940 | $2,423,280 | | Total shareholders' equity | $9,471,731 | $16,488,176 | Consolidated Statements of Operations The statement of operations shows increased research and development and general and administrative expenses, resulting in a significantly wider loss from operations and net loss Income Statement Item | Income Statement Item | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Research and development | $5,464,250 | $2,123,778 | | General and administrative | $1,995,845 | $1,552,873 | | Loss from operations | $(7,460,095) | $(3,676,651) | | Net Loss | $(7,347,903) | $(3,635,088) | | Net loss per share, basic and diluted | $(0.21) | $(0.19) |