ProMIS Neurosciences (PMN) - 2024 Q4 - Annual Results

Overview and Recent Highlights Corporate Update ProMIS Neurosciences describes 2024 as a transformational year, highlighted by the initiation of a Phase 1b clinical trial for its lead Alzheimer's candidate, PMN310. The company secured significant funding of up to $122.3 million to advance its clinical programs and expanded its intellectual property portfolio with 23 new patents, positioning itself for future innovation in neurodegenerative diseases - Initiated a 100-patient Phase 1b clinical trial for PMN310, the company's lead antibody candidate for Alzheimer's Disease (AD)[2] - Secured up to $122.3 million in funding in 2024 through a PIPE financing deal, providing a strong financial foundation for advancing PMN310 and the broader pipeline[2][9] - Strengthened its intellectual property (IP) portfolio with 23 newly granted or allowed patents since January 2024, including 17 related to PMN310 and the first patent allowance for its alpha-synuclein programs (PMN442 and PMN440)[2] Pipeline and Program Updates The company is actively advancing its clinical and preclinical programs. The lead candidate, PMN310 for Alzheimer's, has entered a Phase 1b trial with interim results expected in H1 2026. Concurrently, ProMIS is progressing its preclinical programs for ALS (PMN267) and a vaccine for synucleinopathies (PMN440), with new data for both scheduled for presentation at major 2025 conferences Alzheimer's Disease Program (PMN310) - Initiated PRECISE-AD, a Phase 1b randomized, double-blind, placebo-controlled study of PMN310 in approximately 100 patients with Stage 3 and Stage 4 Alzheimer's Disease across 22 U.S. sites[3] - The PRECISE-AD trial timeline includes six-month interim results in the first half of 2026 and topline results by the end of 2026[1][3] - Successfully completed a Phase 1a study, which showed PMN310 was generally well-tolerated and crossed the blood-brain barrier in healthy volunteers in a dose-dependent manner[8] - The company continues to advance its Aβ vaccine program and will present preclinical data at the AD/PD and AAN conferences in April 2025[4] Amyotrophic Lateral Sclerosis (ALS) Program (PMN267) - PMN267 is a humanized antibody targeting toxic misfolded TDP-43 for ALS[5] - The company will present preclinical proof-of-concept data at the 2025 AD/PD Conference, supporting the selective targeting of misfolded TDP-43 aggregates[5] Multiple Synucleinopathies Vaccine Program (PMN440) - ProMIS will present preclinical data for its alpha-synuclein vaccine candidate, PMN440, at both the 2025 AD/PD International Conference and the AAN Annual Meeting[6] - The data supports the development of PMN440 as a potential treatment for synucleinopathies like Parkinson's disease (PD), dementia with Lewy bodies, and multiple system atrophy (MSA)[6] Financial Results Full Year 2024 Financial Highlights For the fiscal year 2024, ProMIS reported a significant turnaround to a net income of $2.8 million from a net loss of $13.2 million in 2023, primarily due to a $22.6 million gain on the change in fair value of warrant liabilities. Cash and cash equivalents increased to $13.3 million. R&D expenses rose to $10.6 million due to clinical trial activities, while G&A expenses saw a slight decrease | Financial Metric | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $13.3 million | $12.6 million | +$0.7 million | | Research and development expenses | $10.6 million | $7.9 million | +$2.7 million | | General and administrative expenses | $6.2 million | $6.4 million | -$0.2 million | | Net Income (Loss) | $2.8 million | ($13.2 million) | +$16.0 million | - The increase in R&D expenses was primarily driven by costs related to the execution of the Phase 1a clinical trial and the initiation of the Phase 1b clinical trial for PMN310[9] - The shift to net income was primarily attributable to a non-cash gain of $22.6 million on the change in fair value of the company's warrant liabilities[9] Consolidated Financial Statements The consolidated financial statements detail the company's financial position and performance. The balance sheet as of December 31, 2024, shows total assets of $18.9 million and total liabilities of $2.4 million, resulting in a significant increase in total shareholders' equity to $16.5 million. The statement of operations for the year ended December 31, 2024, reflects a net income of $2.8 million, or $0.11 per share, a substantial improvement from the prior year's net loss Consolidated Balance Sheets | As of December 31, | 2024 | 2023 | | :--- | :--- | :--- | | Assets | | | | Cash | $13,291,167 | $12,598,146 | | Total current assets | $18,911,456 | $13,619,145 | | Total assets | $18,911,456 | $13,619,145 | | Liabilities & Equity | | | | Total current liabilities | $2,218,425 | $9,349,662 | | Total liabilities | $2,423,280 | $9,865,849 | | Total shareholders' equity | $16,488,176 | $3,753,296 | Consolidated Statements of Operations | For the Year Ended December 31, | 2024 | 2023 | | :--- | :--- | :--- | | Research and development | $10,637,976 | $7,883,165 | | General and administrative | $6,189,502 | $6,379,568 | | Loss from operations | ($16,827,478) | ($14,262,733) | | Change in fair value of financial instruments | $22,581,477 | $866,738 | | Net income (loss) | $2,778,873 | ($13,212,482) | | Net income (loss) per share, basic | $0.11 | ($1.07) |