Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Commission File Number 001-41429 PROMIS NEUROSCIENCES INC. (Exact name of Registrant as specified in its Charter) Ontario, Canada 98-0647155 (State or other jurisdiction of incorporation or organization) Suite 200, 1920 Yonge Street (I.R.S. Employer Identification No.) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2 ...

Exhibit 99.1 ProMIS Neurosciences Announces Second Quarter 2025 Financial Results & Corporate Highlights U.S. FDA Grants Fast Track Designation for PMN310 in Alzheimer's Disease, enhancing program's potential for priority review PRECISE-AD Phase 1b Trial in Alzheimer's Disease Progressing on Schedule: Over 50% enrolled, no cases of ARIA and no patient dropouts to date Strengthened Financial Position with $21.6 Million in Gross Proceeds Raised in July 2025 Cambridge, Massachusetts – August 13, 2025 ProMIS Ne ...

Core Insights - ProMIS Neurosciences Inc. has received Fast Track designation from the FDA for its lead therapeutic candidate PMN310, aimed at treating Alzheimer's disease [1][2][3] - The Fast Track designation is intended to expedite the development of therapies addressing serious conditions and unmet medical needs, allowing for enhanced engagement with the FDA [2] - PMN310 is designed to selectively target toxic forms of amyloid-beta, potentially reducing serious side effects associated with current Alzheimer's treatments [3][5] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies for neurodegenerative diseases, including Alzheimer's disease, ALS, and Parkinson's disease [7] - The company utilizes its proprietary EpiSelect™ technology to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are implicated in neurodegenerative diseases [7] Clinical Trials - The ongoing PRECISE-AD Phase 1b trial is evaluating PMN310 in early Alzheimer's patients, focusing on safety, tolerability, pharmacokinetics, and biomarkers [3][6] - Interim biomarker and safety data from the trial are expected to be reported in Q2 2026, with final results anticipated in Q4 2026 [3][6] - The trial is designed to provide insights into the effects of PMN310 on biomarkers and clinical outcomes, with a particular emphasis on assessing the risk of ARIA [6] Market Context - Alzheimer's disease affects over 6 million people in the U.S. and is a leading cause of death and disability among older adults, highlighting the urgent need for safer and more effective treatment options [4] - PMN310 aims to offer a differentiated approach by selectively targeting toxic oligomers, potentially leading to improved efficacy and reduced side effects compared to existing therapies [5]

Core Insights - The FDA has granted Fast Track designation to PMN310, a therapeutic candidate by ProMIS Neurosciences for Alzheimer's disease, highlighting its potential to address an unmet medical need [1][2][3] - PMN310 is designed to selectively target toxic oligomers of amyloid-beta, potentially reducing side effects associated with current treatments [3][5] - The ongoing PRECISE-AD Phase 1b trial is evaluating PMN310's safety, tolerability, and pharmacokinetics, with interim results expected in Q2 2026 [3][6] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies for neurodegenerative diseases, including Alzheimer's, ALS, and Parkinson's [1][7] - The company utilizes its proprietary EpiSelect™ technology to identify Disease Specific Epitopes (DSEs) on misfolded proteins [7][8] Industry Context - Alzheimer's disease affects over 6 million people in the U.S. and is a leading cause of death and disability among older adults, indicating a significant need for effective treatments [4] - The Fast Track program by the FDA aims to expedite the development of therapies for serious conditions, which is crucial for addressing the urgent need for safer and more targeted Alzheimer's treatments [2][4]

Summary of ProMIS Neurosciences (PMN) FY Conference Call Company Overview - **Company**: ProMIS Neurosciences (PMN) - **Industry**: Biotechnology, focusing on neurodegenerative disorders, particularly Alzheimer's disease [1][4] Key Points and Arguments Alzheimer's Disease Opportunity - Alzheimer's disease is a significant global epidemic, especially with the aging population in developed countries [4] - There is a substantial unmet medical need in Alzheimer's treatment, with millions of patients suffering [7] - Current market products, donanemab and lecanemab, are generating revenue but are underperforming expectations [7] - Existing treatments show modest efficacy and significant side effects, particularly ARIA (amyloid-related imaging abnormalities) [8][9] ProMIS's Approach - ProMIS aims to develop differentiated therapeutics that address the underlying pathology of Alzheimer's disease [6] - The company is focused on creating antibodies that improve efficacy while reducing side effects, particularly ARIA [10][18] - The Episelect platform allows ProMIS to selectively target harmful misfolded proteins, avoiding non-pathogenic forms [21][24] ARIA and Its Impact - ARIA occurs in 15-30% of patients treated with current anti-amyloid drugs, leading to significant concerns regarding treatment [13][15] - The presence of ARIA affects physician prescribing habits and overall treatment uptake [14][16] - ProMIS believes it can develop antibodies that minimize ARIA risk while maintaining efficacy [18][41] PMN310 Development - PMN310 is currently in Phase 1b trials (PRECISE AD) with interim results expected in the first half of next year [45][51] - The study involves 100 patients with early Alzheimer's disease, measuring biomarkers, safety, and clinical signals [48][49] - The interim analysis will focus on ARIA incidents, with expectations that PMN310 will show no ARIA liability [53] Pipeline and Future Prospects - ProMIS is also developing PMN267 for ALS and PMN440 for synucleinopathies, with a focus on selectively targeting misfolded proteins [55][59] - The company is exploring a vaccine approach for Alzheimer's that could allow individuals to produce their own PMN310 [62][63] - The potential for PMN310 to become a blockbuster drug exists if it can deliver improved efficacy without ARIA [42] Other Important Content - The discussion highlighted the importance of understanding protein misfolding and the need for targeted therapies in neurodegenerative diseases [22][27] - ProMIS's unique approach to targeting toxic oligomers while avoiding plaque and beneficial monomers sets it apart from competitors [30][31] - The company is optimistic about its ability to deliver a safer and more effective treatment for Alzheimer's, which could significantly impact patient compliance and treatment outcomes [42][43]

Core Viewpoint - ProMIS Neurosciences Inc. is actively engaged in the development of therapeutic antibodies targeting toxic oligomers linked to neurodegenerative diseases, with a focus on Alzheimer's Disease, ALS, and MSA [1][3]. Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company based in Cambridge, Massachusetts, and Toronto, Ontario, specializing in the discovery and development of therapeutic antibodies for misfolded protein diseases [3]. - The company utilizes its proprietary target discovery engine, EpiSelect™, to identify Disease Specific Epitopes (DSEs) on misfolded proteins associated with various neurodegenerative diseases [3]. Product Development - PMN310 is the lead product candidate for Alzheimer's Disease, designed as a humanized monoclonal antibody that selectively targets toxic oligomers while avoiding plaque, potentially enhancing safety and efficacy compared to other therapies [4]. - The PRECISE-AD trial is a Phase 1b clinical study initiated to evaluate the safety, tolerability, and pharmacokinetics of PMN310 in patients with Mild Cognitive Impairment and mild Alzheimer's Disease [5]. - The trial aims to assess the effects of PMN310 on biomarkers related to Alzheimer's pathology and clinical outcomes, with a primary focus on safety and reduced risk of ARIA due to its non-plaque binding nature [5].

PART I: FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Unaudited Q1 2025 financials show a widened net loss and decreased cash, raising substantial doubt about its going concern status Condensed Consolidated Balance Sheet Data | Balance Sheet Items | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash | $8,364,301 | $13,291,167 | | Total Current Assets | $13,646,671 | $18,911,456 | | Total Assets | $13,646,671 | $18,911,456 | | 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 | Condensed Consolidated Statements of Operations Data | Operations Items | Three Months Ended March 31, 2025 | Three Months Ended March 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) | Condensed Consolidated Statements of Cash Flows Data | Cash Flow Items | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,926,866) | $(10,291,447) | | Net cash provided by financing activities | $0 | $190,274 | | Net decrease in cash | $(4,926,866) | $(10,101,173) | | Cash at end of period | $8,364,301 | $2,496,973 | - The company has a history of net losses, an **accumulated deficit of $98.0 million** as of March 31, 2025, and **negative operating cash flows of $4.9 million** for the quarter, raising substantial doubt about its ability to continue as a going concern[29](index=29&type=chunk)[30](index=30&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's net loss widened due to increased R&D for its lead candidate PMN310, with current cash deemed insufficient - The company's lead product candidate is **PMN310**, a monoclonal antibody for Alzheimer's disease, which entered a **Phase 1b clinical trial** (PRECISE-AD) in December 2024[95](index=95&type=chunk)[100](index=100&type=chunk) Results of Operations Comparison | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $5,464,250 | $2,123,778 | $3,340,472 | | General and administrative | $1,995,845 | $1,552,873 | $442,972 | | **Net loss** | **$(7,347,903)** | **$(3,635,088)** | **$(3,712,815)** | - **R&D expenses increased by $3.3 million (157%)** in Q1 2025 compared to Q1 2024, mainly due to a $3.2 million increase in costs for the PMN310 phase 1b trial[121](index=121&type=chunk) - **General and administrative expenses increased by $0.4 million (29%)**, largely due to $0.5 million in severance costs recognized in Q1 2025[122](index=122&type=chunk) - The company's **cash of $8.4 million** as of March 31, 2025, is **insufficient to fund operations for the next 12 months**, raising substantial doubt about its ability to continue as a going concern[100](index=100&type=chunk)[131](index=131&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to credit, liquidity, and inflation risks, with liquidity being a significant concern for the pre-revenue entity - The company's primary financial risks are **credit risk, liquidity risk, and market risk**[142](index=142&type=chunk) - **Liquidity risk is a major concern**, as the company is pre-revenue and relies on external fundraising to support its operations and meet commitments[146](index=146&type=chunk) - **Inflation is not considered to have had a material impact** on the company's financial condition or results for the three months ended March 31, 2025[147](index=147&type=chunk) [Item 4. Controls and Procedures](index=47&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of March 31, 2025, due to an unremediated material weakness - Management concluded that **disclosure controls and procedures were not effective** as of March 31, 2025, due to a material weakness in internal control over financial reporting[149](index=149&type=chunk) - The material weakness relates to the failure to design **sufficient review controls over certain fair value calculations**, including the July 2024 PIPE Warrant Liability[150](index=150&type=chunk) - **Remediation measures are underway**, but the material weakness was not yet remediated as of the report date[151](index=151&type=chunk)[152](index=152&type=chunk) PART II: OTHER INFORMATION [Item 1. Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material litigation or legal proceedings - As of the report date, the company is **not involved in any material legal proceedings**[155](index=155&type=chunk) [Item 1A. Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) Key risks include a history of losses, going concern uncertainty, and a material weakness in internal financial controls - The company has **incurred losses since inception** and anticipates continued losses, raising substantial doubt about its ability to continue as a going concern[157](index=157&type=chunk) - **Failure to obtain necessary additional financing** could force the company to delay, limit, reduce, or terminate its development programs and commercialization efforts[157](index=157&type=chunk)[160](index=160&type=chunk) - A **material weakness in internal control over financial reporting** has been identified, which could adversely affect investor confidence and the company's ability to report financial results accurately and timely[161](index=161&type=chunk)[162](index=162&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=50&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) No unregistered sales of equity securities, use of proceeds, or issuer purchases occurred during the period - No unregistered sales of equity securities or issuer purchases were made during the period[165](index=165&type=chunk) [Item 6. Exhibits](index=52&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including agreement amendments, officer certifications, and interactive data files - Exhibits filed include an amendment to the Collaborative Research Agreement with the University of British Columbia, **CEO and CFO certifications** pursuant to Sarbanes-Oxley Sections 302 and 906, and Inline XBRL documents[170](index=170&type=chunk)

[Business and Clinical Highlights](index=1&type=section&id=Business%20and%20Clinical%20Highlights) 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](index=2&type=chunk) - 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](index=2&type=chunk) - 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](index=2&type=chunk)[4](index=4&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) 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)](index=1&type=section&id=Alzheimer%27s%20Disease%20Program%20%28PMN310%29) 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](index=3&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk) - 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](index=4&type=chunk) [Other Pipeline Programs](index=3&type=section&id=Other%20Pipeline%20Programs) 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](index=4&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - 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](index=7&type=chunk) - 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](index=7&type=chunk)[12](index=12&type=chunk) [First Quarter 2025 Financial Results](index=4&type=section&id=First%20Quarter%202025%20Financial%20Highlights) 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](index=7&type=section&id=Consolidated%20Financial%20Statements) 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](index=7&type=section&id=Consolidated%20Balance%20Sheets) 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](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) 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) |

Overview and Recent Highlights [Corporate Update](index=1&type=section&id=Corporate%20Update) 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](index=2&type=chunk) - 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](index=2&type=chunk)[9](index=9&type=chunk) - 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](index=2&type=chunk) [Pipeline and Program Updates](index=1&type=section&id=Pipeline%20and%20Program%20Updates) 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)](index=1&type=section&id=Alzheimer%27s%20Disease%20Program%20%28PMN310%29) - 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](index=3&type=chunk) - 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](index=1&type=chunk)[3](index=3&type=chunk) - 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](index=8&type=chunk) - 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](index=4&type=chunk) [Amyotrophic Lateral Sclerosis (ALS) Program (PMN267)](index=3&type=section&id=Amyotrophic%20Lateral%20Sclerosis%20%28ALS%29%20Program%20%28PMN267%29) - PMN267 is a humanized antibody targeting toxic misfolded TDP-43 for ALS[5](index=5&type=chunk) - 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](index=5&type=chunk) [Multiple Synucleinopathies Vaccine Program (PMN440)](index=3&type=section&id=Multiple%20Synucleinopathies%20Vaccine%20Program%20%28PMN440%29) - 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](index=6&type=chunk) - 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](index=6&type=chunk) Financial Results [Full Year 2024 Financial Highlights](index=3&type=section&id=Full%20Year%202024%20Financial%20Highlights) 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](index=9&type=chunk) - 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](index=9&type=chunk) [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) 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](index=6&type=section&id=Consolidated%20Balance%20Sheets) | 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](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) | 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)** |

PART I [Business](index=7&type=section&id=Item%201.%20Business) A clinical-stage biotech firm developing therapies for neurodegenerative diseases via a proprietary computational platform - ProMIS utilizes a patented computational technology platform to discover and develop antibody therapies and vaccines for neurodegenerative diseases by **selectively targeting toxic misfolded proteins**[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) Product Pipeline Overview | Category | Product Candidate | Target Protein | Disease Indication(s) | Stage | | :--- | :--- | :--- | :--- | :--- | | **Antibody** | PMN310 | Amyloid-Beta | Alzheimer's Disease (AD) | Phase 1 | | | PMN267 | TDP-43 | Amyotrophic Lateral Sclerosis (ALS) | Pre-Clinical | | | PMN442 | Alpha-Synuclein | Multiple System Atrophy (MSA) | Pre-Clinical | | **Vaccine** | PMN440 | Alpha-Synuclein | Multiple synucleinopathies | Discovery | | | PMN311 | Amyloid-Beta | Alzheimer's Prevention | Discovery | | **Discovery** | - | Tau | FTLD, PSP, CBD | Discovery | | | - | RACK1 | ALS, HD | Discovery | | | - | DISC1+Interactome | Schizophrenia | Discovery | - The company's lead candidate, **PMN310 for Alzheimer's Disease**, initiated a **Phase 1a clinical trial** in November 2023 and a **Phase 1b study** in December 2024[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk) - Key objectives for 2025 include **advancing patient enrollment for PMN310**, expanding corporate visibility, and evaluating partnership opportunities[32](index=32&type=chunk)[34](index=34&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) The company faces risks from its early-stage products, need for funding, going concern uncertainty, and potential Nasdaq delisting - The company has incurred losses since inception, raising **substantial doubt about its ability to continue as a going concern** without additional financing[295](index=295&type=chunk) - The business is heavily dependent on its lead candidate, **PMN310**, which is in early clinical development in a historically challenging field[14](index=14&type=chunk)[248](index=248&type=chunk)[285](index=285&type=chunk) - As of January 3, 2025, the company was **not in compliance with Nasdaq's $1.00 minimum bid price requirement**, risking delisting[477](index=477&type=chunk) - The company **relies on third parties** for manufacturing, research, and clinical trials, posing risks of development delays[14](index=14&type=chunk)[315](index=315&type=chunk) - Management identified that the company's **internal controls over financial reporting are not effective**, which could adversely affect the business[20](index=20&type=chunk)[498](index=498&type=chunk) [Unresolved Staff Comments](index=98&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company has no unresolved staff comments from the Securities and Exchange Commission - There are **no unresolved staff comments**[532](index=532&type=chunk) [Cybersecurity](index=99&type=section&id=Item%201C.%20Cybersecurity) A cybersecurity program is in place with board oversight, and no material incidents have been identified to date - The company has a cybersecurity risk management program with **oversight provided by the Board's Audit Committee**[533](index=533&type=chunk)[536](index=536&type=chunk) - No cybersecurity incidents have been identified that are **reasonably likely to have a material effect** on the business[534](index=534&type=chunk) [Properties](index=99&type=section&id=Item%202.%20Properties) The company does not own or lease any material properties - The Company **does not own or lease any material properties**[537](index=537&type=chunk) [Legal Proceedings](index=99&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The Company is not a party to any legal proceedings expected to have a **material adverse effect** on its business[538](index=538&type=chunk) [Mine Safety Disclosures](index=99&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[539](index=539&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=99&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common shares trade on Nasdaq, and no dividends are planned as funds are reinvested into operations - The company's common shares are listed on the **Nasdaq Capital Market** with 103 holders of record as of March 29, 2025[541](index=541&type=chunk)[542](index=542&type=chunk) - **No dividends have been paid** in the last five years, and none are expected in the foreseeable future[543](index=543&type=chunk)[544](index=544&type=chunk) - In July 2024, the company completed a PIPE offering, raising gross proceeds of **approximately $27.7 million**[549](index=549&type=chunk) [Reserved](index=102&type=section&id=Item%206.%20Reserved) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=103&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The operating loss increased to $16.8 million in 2024, and there is substantial doubt about the company's ability to continue as a going concern Results of Operations (Years Ended December 31) | Metric | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development | $10,637,976 | $7,883,165 | $2,754,811 | | General and administrative | $6,189,502 | $6,379,568 | $(190,066) | | **Loss from operations** | **$(16,827,478)** | **$(14,262,733)** | **$2,564,745** | | Other income (expense) | $19,606,351 | $1,050,251 | $(18,556,100) | | **Net income (loss)** | **$2,778,873** | **$(13,212,482)** | **$(15,991,355)** | - The increase in operating loss was driven by a **$3.5 million increase in spending on the lead program, PMN310**[576](index=576&type=chunk) - Management concluded there is **substantial doubt about its ability to continue as a going concern** as cash of $13.3 million is insufficient[567](index=567&type=chunk)[588](index=588&type=chunk) Cash Flow Summary (Years Ended December 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(27,182,095) | $(10,843,676) | | Net cash provided by financing activities | $27,875,809 | $17,748,800 | | **Net increase in cash** | **$693,021** | **$6,722,350** | [Quantitative and Qualitative Disclosures About Market Risk](index=111&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is primarily exposed to credit and liquidity risks, while foreign currency and inflation risks are not material - The company's primary financial risks include **credit risk and significant liquidity risk**, as it relies on external financing[600](index=600&type=chunk)[601](index=601&type=chunk)[602](index=602&type=chunk) - **Foreign currency and inflation risks** are not believed to have had a material impact on financial results in 2024 or 2023[603](index=603&type=chunk)[604](index=604&type=chunk) [Financial Statements and Supplementary Data](index=200&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The auditor's report highlights a "Going Concern Uncertainty" due to the company's history of net losses and negative cash flows - The independent auditor's report includes a **"Going Concern Uncertainty"** paragraph due to accumulated deficits and net losses[608](index=608&type=chunk) Consolidated Balance Sheet Highlights (as of Dec 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Cash | $13,291,167 | $12,598,146 | | Total Current Assets | $18,911,456 | $13,619,145 | | Total Current Liabilities | $2,218,425 | $9,349,662 | | Total Liabilities | $2,423,280 | $9,865,849 | | Accumulated Deficit | $(90,687,073) | $(93,465,946) | | Total Shareholders' Equity | $16,488,176 | $3,753,296 | Consolidated Statement of Operations Highlights (Year Ended Dec 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Total operating expenses | $16,827,478 | $14,262,733 | | Loss from operations | $(16,827,478) | $(14,262,733) | | Net income (loss) | $2,778,873 | $(13,212,482) | | Net income (loss) per share, basic | $0.11 | $(1.07) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=100&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There were no changes in or disagreements with the company's accountants - None[745](index=745&type=chunk) [Controls and Procedures](index=100&type=section&id=Item%209A.%20Controls%20and%20Procedures) Disclosure controls were deemed ineffective due to a material weakness in internal control over financial reporting - Management concluded that **disclosure controls and procedures were not effective** as of December 31, 2024, due to a material weakness[747](index=747&type=chunk)[754](index=754&type=chunk) - A material weakness was identified related to **insufficient review controls over fair value calculations** for the PIPE Warrant Liability[753](index=753&type=chunk) - The company has initiated **remediation measures** to address the material weakness[755](index=755&type=chunk) [Other Information](index=101&type=section&id=Item%209B.%20Other%20Information) No directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement in Q4 2024 - No directors or officers adopted, terminated, or modified a **Rule 10b5-1 trading arrangement** during Q4 2024[758](index=758&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=102&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This section is not applicable to the company - Not applicable[759](index=759&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=102&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This information is incorporated by reference from the company's 2025 definitive proxy statement - Information for this item is **incorporated by reference** from the registrant's 2025 Proxy Statement[761](index=761&type=chunk) [Executive Compensation](index=102&type=section&id=Item%2011.%20Executive%20Compensation) This information is incorporated by reference from the company's 2025 definitive proxy statement - Information for this item is **incorporated by reference** from the registrant's 2025 Proxy Statement[765](index=765&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=102&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This information is incorporated by reference from the company's 2025 definitive proxy statement - Information for this item is **incorporated by reference** from the registrant's 2025 Proxy Statement[766](index=766&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=102&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) This information is incorporated by reference from the company's 2025 definitive proxy statement - Information for this item is **incorporated by reference** from the registrant's 2025 Proxy Statement[767](index=767&type=chunk) [Principal Accountant Fees and Services](index=103&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) This information is incorporated by reference from the company's 2025 definitive proxy statement - Information for this item is **incorporated by reference** from the registrant's 2025 Proxy Statement[768](index=768&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=103&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed as part of the Annual Report - This item lists the financial statements and exhibits filed with the Form 10-K; **all schedules are omitted**[769](index=769&type=chunk) [Form 10-K Summary](index=103&type=section&id=Item%2016.%20Form%2010-K%20Summary) This section is not applicable - Not applicable[771](index=771&type=chunk)