Summary of ProMIS Neurosciences FY Conference Call Company Overview - **Company Name**: ProMIS Neurosciences - **Ticker Symbol**: PMN - **Focus**: Development of antibody therapies targeting protein misfolding, particularly in neurodegenerative diseases like Alzheimer's [3][4] Core Points and Arguments - **Technology Platform**: ProMIS utilizes the EpiSelect platform to generate highly selective antibodies aimed at misfolded proteins, which are implicated in various diseases [4][10] - **Lead Program**: The lead program, PMN310, is currently in a Phase 1b/2 study for Alzheimer's disease, with over 100 patients enrolled across 22 sites in the US [7][8] - **Differentiation**: The company emphasizes the importance of having a differentiated product in the competitive Alzheimer's space, particularly regarding efficacy and safety profiles [5][6] - **Safety Profile**: ProMIS claims that PMN310 has a better safety profile compared to existing treatments, particularly concerning ARIA (Amyloid-related imaging abnormalities), which is a significant side effect associated with current Alzheimer's therapies [6][30] - **Clinical Study Design**: The Phase 1b study is designed to last 12 months, focusing on both biomarker and clinical endpoints, with an interim analysis expected in Q2 of the following year [8][34] - **FDA Fast Track Designation**: PMN310 has received fast track approval from the FDA, indicating the agency's recognition of the potential therapeutic benefit of the drug [8][35] Pipeline and Future Programs - **Additional Candidates**: Besides PMN310, ProMIS is developing other candidates targeting misfolded proteins associated with ALS (PMN267) and Parkinson's disease [12] - **Vaccine Program**: The company is also exploring a vaccine program that follows a similar approach to their therapeutic candidates [12] Market Context - **Unmet Medical Need**: There is a significant unmet medical need in Alzheimer's treatment, with existing products showing modest efficacy and challenging risk-benefit profiles [38] - **Commercial Validation**: Despite the challenges, existing Alzheimer's drugs are generating substantial revenue, indicating a market opportunity for safer and more effective treatments [37][38] Important but Overlooked Content - **Interim Analysis**: The interim analysis will focus on biomarker profiles rather than clinical endpoints, which may provide early insights into the drug's efficacy [32][34] - **Patient Population**: The current study focuses on patients with mild Alzheimer's disease and mild cognitive impairment (MCI), with plans to expand to more moderate to severe cases in future studies [41][42] - **Robust Study Design**: The Phase 1b study is designed to be more comprehensive than typical Phase 2 studies, potentially allowing ProMIS to skip a traditional Phase 2 trial if results are favorable [42] This summary encapsulates the key points discussed during the ProMIS Neurosciences FY Conference Call, highlighting the company's focus on innovative therapies for Alzheimer's disease and its strategic positioning within the market.

Core Insights - ProMIS Neurosciences has received unanimous recommendation from the Data and Safety Monitoring Board (DSMB) to proceed to the third and final dose escalation cohort in the PRECISE-AD Phase 1b clinical trial for PMN310, aimed at treating Alzheimer's disease (AD) [2][3] - The trial is on track to enroll 128 patients and is expected to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026 [1][2] - No cases of amyloid-related imaging abnormalities (ARIA) have been observed to date, indicating a favorable safety profile for PMN310 [1][2][3] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapies for neurodegenerative diseases, particularly Alzheimer's disease [5][6] - The company utilizes its proprietary EpiSelect™ platform to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are implicated in neurodegenerative diseases [5][9] - PMN310 is a humanized IgG1 antibody designed to selectively target toxic amyloid-beta oligomers while avoiding plaque, potentially reducing ARIA liability [7][8] Clinical Trial Details - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of multiple ascending doses of PMN310 in patients with Mild Cognitive Impairment due to AD and mild AD [8] - The trial aims to provide insights into the effects of PMN310 on biomarkers associated with AD pathology and clinical outcomes, with a primary focus on safety [8] - The DSMB has cleared the trial to proceed to the next dosing level, increasing the dose from 10 mg/kg in the second cohort to 20 mg/kg in the final cohort [3][7] Future Outlook - The company anticipates that the ongoing clinical trials will provide critical insights into target engagement, neuronal injury, and potential disease-modifying effects of PMN310 [3][8] - ProMIS Neurosciences plans to discuss clinical progress and corporate updates at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025 [4]

[DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS](index=4&type=section&id=DISCLOSURE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section outlines the nature of forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially - Forward-looking statements are based on current beliefs, expectations, or assumptions about the future of the business, plans, strategies, and operational results, rather than historical facts[7](index=7&type=chunk) - These statements are subject to known and unknown risks and uncertainties, as well as assumptions that could cause actual results to differ materially from those projected[7](index=7&type=chunk)[9](index=9&type=chunk) - Key areas covered by forward-looking statements include contingent payments, R&D costs, foreign currency risk, fair value estimates, competition, patent terms, corporate strategy, liquidity, Nasdaq listing, business growth drivers, product candidate development timelines, legal proceedings, and the impact of global events and healthcare reforms[8](index=8&type=chunk)[11](index=11&type=chunk) [PART I — FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents the company's unaudited interim financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, providing a snapshot of the company's financial position and performance [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section details the company's assets, liabilities, and shareholders' deficit at the end of the reporting period **Condensed Consolidated Balance Sheet Highlights** | Metric | 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 | | Total shareholders' (deficit) equity | $(382,578) | $16,488,176 | $(16,870,754) | | Accumulated deficit | $(108,152,005) | $(90,687,073) | $(17,464,932) | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section presents the company's operating expenses and net loss for the reported interim periods **Condensed Consolidated Statements of Operations Highlights** | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $8,749,784 | $1,625,821 | $14,214,034 | $3,749,599 | | General and administrative | $1,434,877 | $1,087,885 | $3,430,723 | $2,640,758 | | Total operating expenses | $10,184,661 | $2,713,706 | $17,644,757 | $6,390,357 | | Net loss | $(10,117,029) | $(2,623,657) | $(17,464,932) | $(6,258,745) | | Net loss per share (basic & diluted) | $(0.29) | $(0.13) | $(0.50) | $(0.32) | - Research and development expenses increased significantly by **438%** for the three months ended June 30, 2025, and **284%** for the six months ended June 30, 2025, compared to the prior year periods[17](index=17&type=chunk) [Condensed Consolidated Statements of Changes in Shareholders' Deficit](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Deficit) This section details the changes in the components of shareholders' deficit during the reporting period **Changes in Shareholders' Deficit (January 1, 2025 to June 30, 2025)** | Item | Balance, Jan 1, 2025 | Share-based compensation expense | Re-measurement of liability-classified CAD stock options | Net loss | Balance, June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | | Additional Paid-in Capital | $107,546,433 | $457,310 | $136,868 | — | $108,140,611 | | Accumulated Deficit | $(90,687,073) | — | — | $(17,464,932) | $(108,152,005) | | Total Shareholders' (Deficit) Equity | $16,488,176 | $457,310 | $136,868 | $(17,464,932) | $(382,578) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities **Condensed Consolidated Statements of Cash Flows Highlights** | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net Loss | $(17,464,932) | $(6,258,745) | | Net cash used in operating activities | $(8,781,048) | $(11,795,957) | | Net cash provided by financing activities | — | $190,274 | | Net decrease in cash | $(8,781,048) | $(11,605,683) | | Cash at end of period | $4,510,119 | $992,463 | - Cash used in operating activities decreased by **$3.0 million** for the six months ended June 30, 2025, compared to the same period in 2024, despite a higher net loss, due to favorable changes in operating assets and liabilities, particularly increases in accrued liabilities and accounts payable[24](index=24&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed disclosures and explanations of the amounts presented in the financial statements [1. DESCRIPTION OF BUSINESS](index=12&type=section&id=1.%20DESCRIPTION%20OF%20BUSINESS) This note describes the company's focus on developing therapies for neurodegenerative diseases and its current financial challenges - ProMIS Neurosciences Inc. develops antibody therapies and therapeutic vaccines for neurodegenerative diseases like Alzheimer's, MSA, and ALS, focusing on misfolded proteins[27](index=27&type=chunk) - The company's lead product candidates include PMN310 for AD, PMN267 for ALS, and PMN442 for MSA and Parkinson's disease, all designed to selectively target toxic misfolded proteins[28](index=28&type=chunk) - The company's success is dependent on obtaining regulatory approvals, marketing products, and securing additional financing, with management expressing **substantial doubt about its ability to continue as a going concern** due to ongoing losses and funding needs[30](index=30&type=chunk)[31](index=31&type=chunk) [2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=13&type=section&id=2.%20BASIS%20OF%20PRESENTATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the accounting principles and policies used in preparing the financial statements - The financial statements are prepared in conformity with U.S. GAAP and include all normal recurring adjustments necessary for fair presentation[35](index=35&type=chunk)[36](index=36&type=chunk) - The company operates as a single operating segment (life science) and consolidates its wholly-owned subsidiary, ProMIS USA[38](index=38&type=chunk)[40](index=40&type=chunk) - As an Emerging Growth Company, ProMIS has elected to use the extended transition period for complying with new or revised accounting standards[41](index=41&type=chunk) [3. FAIR VALUE MEASUREMENTS](index=17&type=section&id=3.%20FAIR%20VALUE%20MEASUREMENTS) This note provides details on the fair value hierarchy for financial assets and liabilities **Fair Value Measurements (June 30, 2025)** | Category | Level 1 | Level 2 | Level 3 | Total | | :--- | :--- | :--- | :--- | :--- | | Short-term investments | $33,051 | $— | $— | $33,051 | | Share-based compensation liability | $— | $— | $62,395 | $62,395 | | Warrant liability | $— | $— | $5,592 | $5,592 | **Fair Value Measurements (December 31, 2024)** | Category | Level 1 | Level 2 | Level 3 | Total | | :--- | :--- | :--- | :--- | :--- | | Short-term investments | $33,051 | $— | $— | $33,051 | | Share-based compensation liability | $— | $— | $199,263 | $199,263 | | Warrant liability | $— | $— | $5,592 | $5,592 | - Share-based compensation liability decreased from **$199,263** at December 31, 2024, to **$62,395** at June 30, 2025[45](index=45&type=chunk) [4. PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=17&type=section&id=4.%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) This note details the components of prepaid expenses and other current assets **Prepaid Expenses and Other Current Assets** | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Upfront research payments | $4,759,310 | $5,087,692 | | Accrued interest and other receivables | $29,484 | $78,034 | | Insurance | $89,136 | $335,976 | | License fees | $75,352 | $38,255 | | Miscellaneous | $13,044 | $47,281 | | **Total** | **$4,966,326** | **$5,587,238** | [5. ACCRUED LIABILITIES AND ACCOUNTS PAYABLE](index=17&type=section&id=5.%20ACCRUED%20LIABILITIES%20AND%20ACCOUNTS%20PAYABLE) This note details the components of accrued liabilities **Accrued Liabilities** | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Legal | $33,931 | $44,610 | | Accounting | $138,096 | $95,182 | | Research and development | $6,564,059 | $223,559 | | Severance | $303,546 | $38,328 | | Other | $4,276 | $79,283 | | **Total** | **$7,043,908** | **$480,962** | - Research and development accrued liabilities increased by over **$6.3 million** from December 31, 2024, to June 30, 2025[47](index=47&type=chunk) [6. EQUITY](index=19&type=section&id=6.%20EQUITY) This note describes the company's equity structure, including common shares, warrants, and recent financing activities **Common Shares Reserved for Future Issuance** | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Warrants | 57,141,386 | 57,141,386 | | Options issued and outstanding | 3,760,859 | 3,574,453 | | Deferred Share Units granted | 1,061 | 1,061 | | Common Shares available for grant | 2,776,979 | 2,963,385 | | **Total** | **63,680,285** | **63,680,285** | - In July 2024, the company completed a private placement (PIPE) raising **$30.3 million** gross proceeds, involving common share units and pre-funded units with various warrants[53](index=53&type=chunk)[54](index=54&type=chunk) - The Tranche A and B Warrants from the July 2024 PIPE were initially classified as liabilities due to shareholder approval requirements, then reclassified to equity after approval on October 23, 2024, resulting in a **$22.5 million** change in fair value recorded as other income (expense)[57](index=57&type=chunk)[59](index=59&type=chunk) [7. WARRANTS](index=23&type=section&id=7.%20WARRANTS) This note provides a summary of the outstanding common share warrants **Outstanding Common Share Warrants (June 30, 2025)** | Exercise Price ($) | Number of Warrants | Expiry Date | | :--- | :--- | :--- | | C$12.00 | 279,613 | November 2025 | | US$2.02 | 14,128,696 | January 2026 | | US$12.60 | 524,088 | August 2026 | | US$9.60 | 146,744 | August 2026 | | US$2.02 | 14,128,696 | January 2027 | | US$7.50 | 345,938 | April 2028 | | US$6.10 | 69,188 | April 2028 | | US$1.75 | 11,227,714 | February 2029 | | US$2.50 | 14,128,696 | July 2029 | | US$0.01 | 2,162,013 | None | | **Total** | **57,141,386** | | - No warrant exercises occurred during the three or six months ended June 30, 2025[64](index=64&type=chunk) [8. SHARE-BASED COMPENSATION](index=23&type=section&id=8.%20SHARE-BASED%20COMPENSATION) This note details the company's stock option plans and related compensation expenses - The 2025 Stock Option Plan replaced the 2015 plan, reserving **2,946,719 Common Shares** for issuance, with **2,776,979 options** available for grant as of June 30, 2025[65](index=65&type=chunk) **Share-based Compensation Expense** | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $37,883 | $3,813 | $75,557 | $7,625 | | General and administrative | $174,132 | $14,186 | $381,753 | $73,958 | | **Total** | **$212,015** | **$17,999** | **$457,310** | **$81,583** | - Total share-based compensation expense significantly increased to **$457,310** for the six months ended June 30, 2025, from **$81,583** in the prior year, with a substantial portion allocated to general and administrative expenses[72](index=72&type=chunk) [9. SEGMENT REPORTING](index=27&type=section&id=9.%20SEGMENT%20REPORTING) This note describes the company's single operating segment and related financial information - The company has one reportable segment: life science, which involves the development of clinical and preclinical product candidates[73](index=73&type=chunk) - The CODM (Chief Executive Officer) assesses segment performance based on net income (loss) and cash forecast models, as the company has not generated any product revenue to date[75](index=75&type=chunk)[76](index=76&type=chunk) **Segment Operating Expenses and Net Loss** | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | PMN310 development program costs | $8,050,610 | $1,073,864 | $12,776,951 | $2,623,174 | | Total Operating Expenses | $10,184,661 | $2,713,706 | $17,644,757 | $6,390,357 | | Net Loss | $10,117,029 | $2,623,657 | $17,464,932 | $6,258,745 | [10. RELATED PARTY TRANSACTIONS](index=28&type=section&id=10.%20RELATED%20PARTY%20TRANSACTIONS) This note discloses transactions with related parties, including a collaborative research agreement - The company has a collaborative research agreement (CRA) with UBC and Vancouver Coastal Health Authority, extended to February 2026, with aggregate funding increased to **C$5,830,000**[80](index=80&type=chunk) **Related Party Transaction Costs (UBC CRA)** | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Cash payments | $283,600 | $149,160 | | Incurred costs | $283,307 | $294,333 | [11. COMMITMENTS AND CONTINGENCIES](index=28&type=section&id=11.%20COMMITMENTS%20AND%20CONTINGENCIES) This note outlines the company's contractual commitments and potential contingencies - Compensation under research, development, and license agreements typically includes upfront fees, milestone payments, and royalty payments, with no accruals for milestone or royalty amounts required as of June 30, 2025[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) - The company has an ongoing license agreement with UBC, requiring an annual license fee of **C$25,000**, and indemnification agreements with its directors and officers[85](index=85&type=chunk)[86](index=86&type=chunk) [12. NET LOSS PER SHARE](index=30&type=section&id=12.%20NET%20LOSS%20PER%20SHARE) This note explains the calculation of basic and diluted net loss per share **Net Loss Per Share (Basic and Diluted)** | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss | $(10,117,029) | $(2,623,657) | $(17,464,932) | $(6,258,745) | | Weighted-average shares outstanding (basic and diluted) | 34,851,203 | 19,770,739 | 34,851,203 | 19,544,908 | | Net loss per share (basic and diluted) | $(0.29) | $(0.13) | $(0.50) | $(0.32) | - Stock options and warrants were excluded from diluted net loss per share calculation as their effect would be anti-dilutive[87](index=87&type=chunk)[88](index=88&type=chunk) **Potentially Dilutive Common Shares Equivalents Excluded** | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Options issued and outstanding | 3,760,859 | 1,087,493 | | Warrants | 54,979,373 | 12,793,270 | | Series 2 Convertible Preferred Shares | — | 1,166,667 | | Deferred Share Units | 1,061 | 1,061 | | **Total** | **58,741,293** | **15,048,491** | [13. SUBSEQUENT EVENTS](index=31&type=section&id=13.%20SUBSEQUENT%20EVENTS) This note describes significant events that occurred after the balance sheet date - On July 21, 2025, the company terminated its At-the-Market (ATM) Offering Agreement[89](index=89&type=chunk) - In July 2025, the company received aggregate gross proceeds of **$21.6 million** from a registered direct offering ($0.8 million), two private placements ($2.4 million and $3.0 million), and discounted warrant exercises ($15.9 million)[90](index=90&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - The July 22, 2025, and July 29, 2025, PIPE offerings involved the sale of warrants to purchase **12,616,821** and **15,616,360** Common Shares, respectively, both with an exercise price of **$1.25 per share**[91](index=91&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, results of operations, and liquidity, emphasizing significant operating losses and the need for additional funding [Overview](index=34&type=section&id=Overview) This section provides a high-level summary of the company's business, financial performance, and going concern uncertainty - ProMIS is developing antibody therapies for neurodegenerative diseases (AD, MSA, ALS) by selectively targeting misfolded toxic proteins using its patented technology platform[97](index=97&type=chunk)[98](index=98&type=chunk) - The company has incurred significant operating losses since inception, with a net loss of **$17.5 million** for the six months ended June 30, 2025, and an accumulated deficit of **$108.2 million**[100](index=100&type=chunk) - Management believes there is **substantial doubt** about the company's ability to continue as a going concern, requiring significant additional funding to support operations and growth strategy[102](index=102&type=chunk)[104](index=104&type=chunk) [Program Updates](index=36&type=section&id=Program%20Updates) This section details the progress of the company's key therapeutic development programs - PMN310, the lead product candidate for Alzheimer's disease, is in a Phase 1b clinical trial (PRECISE-AD), with all of Cohort 1 and over **50% of Cohort 2 enrolled**, and no cases of ARIA observed to date[105](index=105&type=chunk)[106](index=106&type=chunk)[108](index=108&type=chunk) - PMN310 received **FDA Fast Track Designation** on July 21, 2025, recognizing its potential to address an unmet medical need in AD[108](index=108&type=chunk) - Six-month interim data for PMN310 is anticipated in **Q2 2026**, with topline results expected in **Q4 2026**[108](index=108&type=chunk) - PMN267 (ALS) and PMN442 (MSA) have been humanized and are ready to progress to IND-enabling studies, contingent on sufficient resources[110](index=110&type=chunk)[112](index=112&type=chunk) [Recent Corporate Highlights](index=38&type=section&id=Recent%20Corporate%20Highlights) This section summarizes key corporate achievements and financing activities - PMN310 was granted **Fast Track Designation** by the FDA on July 21, 2025[118](index=118&type=chunk) - As of August 13, 2025, over **50% of planned patient enrollment** for the PMN310 trial has been achieved, with no observed cases of ARIA[118](index=118&type=chunk) - In July 2025, the company received aggregate gross proceeds of **$21.6 million** across multiple transactions, including a registered direct offering, private placements, and discounted warrant exercises[118](index=118&type=chunk) [Components of Operating Results](index=38&type=section&id=Components%20of%20Operating%20Results) This section breaks down the key components of the company's operating results [Revenue](index=38&type=section&id=Revenue) This subsection clarifies the company's current revenue status - The company has not generated any revenue since its inception and does not expect to generate significant revenue from product sales in the near future[116](index=116&type=chunk) [Operating Expenses](index=38&type=section&id=Operating%20Expenses) This subsection details the primary categories of operating expenses [Research and Development Expenses](index=38&type=section&id=Research%20and%20Development%20Expenses) This section describes the costs associated with the company's research and development activities - Research and development expenses primarily consist of employee-related expenses, external research and development expenses (e.g., CROs, consultants), costs for acquiring, developing, and manufacturing clinical study materials, and costs associated with preclinical and clinical activities[117](index=117&type=chunk)[126](index=126&type=chunk) - These expenses are expected to increase substantially as the company advances its product candidates through clinical development and seeks regulatory approvals[121](index=121&type=chunk) [General and Administrative Expenses](index=40&type=section&id=General%20and%20Administrative%20Expenses) This section describes the costs associated with administrative and corporate functions - General and administrative expenses primarily include personnel costs (salary, bonus, benefits, share-based compensation), intellectual property development and protection costs, professional service fees, and other general overhead and facility costs[123](index=123&type=chunk) - These expenses are expected to increase substantially to support business growth and ongoing research and development activities[123](index=123&type=chunk) [Other (Expense) Income](index=40&type=section&id=Other%20(Expense)%20Income) This section describes other non-operating income and expenses - Other (expense) income primarily consists of interest expense on deferred accounts payable, changes in the fair value of financial instruments, and interest income[124](index=124&type=chunk) [Results of Operations - Six Months Ended June 30, 2025 and 2024](index=40&type=section&id=Results%20of%20Operations%20-%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section provides a comparative analysis of operating results for the six-month periods **Results of Operations (Six Months Ended June 30)** | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $14,214,034 | $3,749,599 | $10,464,435 | | General and administrative | $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) | - Research and development expenses increased by **$10.5 million (284%)** for the six months ended June 30, 2025, primarily due to the PMN310 phase 1b trial[128](index=128&type=chunk) - General and administrative expenses increased by **$0.8 million (31%)**, driven by higher employee salaries and benefits (including severance costs) and facility-related costs, partially offset by decreased professional and consulting fees[129](index=129&type=chunk) [Results of Operations - Three Months Ended June 30, 2025 and 2024](index=44&type=section&id=Results%20of%20Operations%20-%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) This section provides a comparative analysis of operating results for the three-month periods **Results of Operations (Three Months Ended June 30)** | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $8,749,784 | $1,625,821 | $7,123,963 | | General and administrative | $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) | - Research and development expenses increased by **$7.1 million (438%)** for the three months ended June 30, 2025, primarily due to the PMN310 phase 1b trial[132](index=132&type=chunk) - General and administrative expenses increased by **$0.3 million (32%)**, driven by higher employee salaries, benefits, and share-based compensation, partially offset by decreased patent and professional/consulting fees[133](index=133&type=chunk)[134](index=134&type=chunk) [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial liquidity, capital resources, and funding needs [Sources of Liquidity](index=46&type=section&id=Sources%20of%20Liquidity) This subsection details the company's primary sources of funding and its current financial position - The company is a pre-revenue development stage company, financing operations through the sale of equity and debt securities and the conversion of warrants and share options[136](index=136&type=chunk) - As of June 30, 2025, cash was **$4.5 million**, with a net loss of **$17.5 million** and negative cash flow from operations of **$8.8 million** for the six months ended June 30, 2025[146](index=146&type=chunk) - In July 2025, the company received aggregate gross proceeds of **$21.6 million** from a registered direct offering, private placements, and discounted warrant exercises[145](index=145&type=chunk)[146](index=146&type=chunk) - Management believes these conditions raise **substantial doubt** about the company's ability to continue as a going concern within the next 12 months, requiring additional funding for future clinical activities and existing liabilities[146](index=146&type=chunk) [Cash Flows](index=48&type=section&id=Cash%20Flows) This subsection provides a detailed analysis of the company's cash flow activities [Cash Flows Used in Operating Activities](index=48&type=section&id=Cash%20Flows%20Used%20in%20Operating%20Activities) This section analyzes the cash used for the company's principal operations - Cash used in operating activities was **$8.8 million** for the six months ended June 30, 2025, primarily due to a net loss of **$17.5 million**, partially offset by non-cash adjustments and favorable changes in operating assets and liabilities[148](index=148&type=chunk) - For the six months ended June 30, 2024, cash used in operating activities was **$11.8 million**, driven by a net loss of **$6.3 million** and a net change of **$5.5 million** in operating assets and liabilities, including a **$5.9 million** repayment on deferred accounts payable[149](index=149&type=chunk)[150](index=150&type=chunk) [Cash Flows Used in Investing Activities](index=50&type=section&id=Cash%20Flows%20Used%20in%20Investing%20Activities) This section analyzes cash flows related to the acquisition and disposal of long-term assets - There was no cash used in investing activities during the six months ended June 30, 2025, or 2024[151](index=151&type=chunk) [Cash Flows from Financing Activities](index=50&type=section&id=Cash%20Flows%20from%20Financing%20Activities) This section analyzes cash flows related to equity and debt financing - No cash was provided by financing activities during the six months ended June 30, 2025[152](index=152&type=chunk) - Cash provided by financing activities during the six months ended June 30, 2024, was **$0.2 million** from the sale of Common Shares under the At The Market Offering Agreement[152](index=152&type=chunk) [Critical Accounting Policies and Estimates](index=50&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section highlights the accounting policies and estimates that are most critical to the financial statements - The company's financial statements are prepared in accordance with U.S. GAAP, requiring management to make significant judgments and estimates, particularly for accruals of research and development expenses[153](index=153&type=chunk) - No material changes to critical accounting estimates have occurred since December 31, 2024[154](index=154&type=chunk) [Recently Issued Accounting Pronouncements](index=50&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section discusses the potential impact of new accounting standards - The company is analyzing the impact of ASU 2024-03, which requires disaggregation of income statement expenses, effective for annual periods starting January 1, 2027[43](index=43&type=chunk)[155](index=155&type=chunk) [Emerging Growth Company Status](index=50&type=section&id=Emerging%20Growth%20Company%20Status) This section describes the company's status as an emerging growth company and its implications - The company is an "emerging growth company" under the JOBS Act and has elected to use the extended transition period for adopting new or revised accounting standards[156](index=156&type=chunk)[157](index=157&type=chunk) [Fully Diluted Share Capital](index=50&type=section&id=Fully%20Diluted%20Share%20Capital) This section provides a summary of the company's fully diluted share capital **Fully Diluted Share Capital (June 30, 2025)** | Item | Number of Common Shares and Common Share Equivalents | | :--- | :--- | | Common Shares | 32,689,190 | | Options issued and outstanding | 3,760,859 | | Warrants | 57,141,386 | | Deferred share units | 1,061 | | **Total** | **93,592,496** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to various market risks, including credit, liquidity, and inflation risk - The company is exposed to credit risk, liquidity risk, and inflation risk in its normal course of business[159](index=159&type=chunk) - Credit risk is managed by placing cash with accredited financial institutions and investing in high-quality government and corporate issuers with low credit risk[160](index=160&type=chunk) - Liquidity risk is managed by continuously monitoring actual and projected cash flows and relying on external fundraising, as the company is a pre-revenue development stage entity[161](index=161&type=chunk) - Inflation did not have a material effect on the company's business, financial condition, or results of operations during the six months ended June 30, 2025[162](index=162&type=chunk) [Item 4. Controls and Procedures](index=52&type=section&id=Item%204.%20Controls%20and%20Procedures) This section evaluates the effectiveness of the company's disclosure controls and procedures and discusses internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=52&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This subsection presents management's conclusion on the effectiveness of disclosure controls - The company's management concluded that its disclosure controls and procedures were **not effective** as of June 30, 2025, due to a previously identified material weakness in internal control over financial reporting[164](index=164&type=chunk) [Material Weakness in Internal Control Over Financial Reporting](index=52&type=section&id=Material%20Weakness%20in%20Internal%20Control%20Over%20Financial%20Reporting) This subsection describes the identified material weakness in internal controls - A **material weakness** was identified in the company's internal control over financial reporting due to the failure to design sufficient and appropriate review controls over certain fair value calculations, including the July 2024 PIPE Warrant Liability[165](index=165&type=chunk) - This material weakness could potentially result in a material misstatement of the company's annual or interim financial statements not being prevented or detected on a timely basis[165](index=165&type=chunk) [Remediation Measures](index=54&type=section&id=Remediation%20Measures) This subsection outlines the steps being taken to address the material weakness - The company has implemented measures to remediate the material weakness, including ensuring appropriate levels of review over the calculation of the fair value of its financial instruments, but there is no assurance these initiatives will ultimately have the intended effects[169](index=169&type=chunk) [Changes in Internal Control Over Financial Reporting](index=54&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) This subsection reports any changes to internal controls during the reporting period - Except for the remediation measures related to the material weakness, there have been no other changes in internal control over financial reporting during the three months ended June 30, 2025, that materially affected or are reasonably likely to materially affect it[170](index=170&type=chunk) [PART II — OTHER INFORMATION](index=54&type=section&id=PART%20II%20OTHER%20INFORMATION) This part contains other required disclosures, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) This section discloses any material pending legal proceedings - The company is not currently a party to any material litigation or legal proceedings that, in management's opinion, are likely to have a material adverse effect on its business[172](index=172&type=chunk) [Item 1A. Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) This section highlights key risks that could adversely affect the company's business, financial condition, and results of operations - There is **substantial doubt** about the company's ability to continue as a **going concern** due to incurred losses and the need for significant additional financing to fund development programs and operations[174](index=174&type=chunk)[175](index=175&type=chunk) - The company has identified a **material weakness** in its internal control over financial reporting related to insufficient review controls over fair value measurements, which could adversely affect financial reporting and investor confidence[178](index=178&type=chunk)[179](index=179&type=chunk) - Changes to U.S. fiscal, tax, and other federal policies, including tariffs and tax reforms, could materially and adversely affect the company's business[182](index=182&type=chunk)[183](index=183&type=chunk)[184](index=184&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=58&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on sales of unregistered equity securities - No unregistered sales of equity securities or use of proceeds occurred during the reporting period[187](index=187&type=chunk) [Item 3. Defaults Upon Senior Securities](index=58&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section reports any defaults on senior securities - No defaults upon senior securities occurred during the reporting period[188](index=188&type=chunk) [Item 4. Mine Safety Disclosures](index=58&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section addresses mine safety disclosures, if applicable - This item is not applicable to the company[189](index=189&type=chunk) [Item 5. Other Information](index=58&type=section&id=Item%205.%20Other%20Information) This section includes any other information not previously reported - No officer or director adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[189](index=189&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists the documents filed as exhibits to the report - The exhibits include forms of Pre-Funded Warrants and Warrants, the 2025 Stock Option and Incentive Plan, Registration Rights Agreements, and certifications required by the Sarbanes-Oxley Act[191](index=191&type=chunk) [Signatures](index=60&type=section&id=Signatures) This section contains the legally required signatures of the company's certifying officers - The report was signed by Neil Warma, Chief Executive Officer, and Daniel Geffken, Chief Financial Officer, on August 13, 2025[197](index=197&type=chunk)

[Executive Summary & Recent Developments](index=1&type=section&id=1.%20Executive%20Summary%20%26%20Recent%20Developments) [Company Overview](index=1&type=section&id=1.1%20Company%20Overview) 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](index=1&type=chunk) [Key Corporate Highlights](index=1&type=section&id=1.2%20Key%20Corporate%20Highlights) 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](index=1&type=chunk)[2](index=2&type=chunk) - 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](index=1&type=chunk)[2](index=2&type=chunk) - Financing in July 2025 generated **$21.6 million in gross proceeds**, strengthening the financial position[1](index=1&type=chunk)[2](index=2&type=chunk) [Research & Development Programs](index=1&type=section&id=2.%20Research%20%26%20Development%20Programs) [EpiSelect™ Drug Discovery Engine](index=1&type=section&id=2.1%20EpiSelect%E2%84%A2%20Drug%20Discovery%20Engine) 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](index=3&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk)[4](index=4&type=chunk) [Alzheimer's Disease Program (PMN310)](index=3&type=section&id=2.2%20Alzheimer's%20Disease%20Program%20(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](index=10&type=chunk) [PRECISE-AD Phase 1b Trial Progress & Safety](index=1&type=section&id=2.2.1%20PRECISE-AD%20Phase%201b%20Trial%20Progress%20%26%20Safety) 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](index=2&type=chunk)[5](index=5&type=chunk) - No amyloid-related imaging abnormalities (ARIA) cases, including brain edema or microhemorrhages, or patient withdrawals have been observed to date[2](index=2&type=chunk)[5](index=5&type=chunk) - 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](index=5&type=chunk) [Regulatory Milestones & Biomarker Insights](index=1&type=section&id=2.2.2%20Regulatory%20Milestones%20%26%20Biomarker%20Insights) 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](index=2&type=chunk)[5](index=5&type=chunk)[10](index=10&type=chunk) 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](index=12&type=chunk) - ProMIS expects to report 6-month blinded interim results for PRECISE-AD in **Q2 2026**, with topline results anticipated in **Q4 2026**[2](index=2&type=chunk)[12](index=12&type=chunk) [Alzheimer's Disease Vaccine Program (PMN311)](index=5&type=section&id=2.3%20Alzheimer's%20Disease%20Vaccine%20Program%20(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](index=6&type=chunk) [Other Neurodegenerative Disease Programs](index=5&type=section&id=2.4%20Other%20Neurodegenerative%20Disease%20Programs) 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)](index=5&type=section&id=2.4.1%20Parkinson's%20Disease%20and%20Multiple%20System%20Atrophy%20(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](index=7&type=chunk) - PMN442 is ready for **IND-enabling studies**[7](index=7&type=chunk) [Amyotrophic Lateral Sclerosis (PMN267)](index=5&type=section&id=2.4.2%20Amyotrophic%20Lateral%20Sclerosis%20(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](index=12&type=chunk) - PMN267 is ready for **IND-enabling studies**[12](index=12&type=chunk) [Financial Performance](index=5&type=section&id=3.%20Financial%20Performance) [Second Quarter 2025 Financial Highlights](index=5&type=section&id=3.1%20Second%20Quarter%202025%20Financial%20Highlights) 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](index=13&type=chunk) - In July 2025, ProMIS obtained **$21.6 million in gross proceeds** through a registered direct offering, private placement, and warrant exercises[2](index=2&type=chunk)[13](index=13&type=chunk) [Consolidated Balance Sheets](index=8&type=section&id=3.2%20Consolidated%20Balance%20Sheets) 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](index=9&type=section&id=3.3%20Consolidated%20Statements%20of%20Operations) 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](index=5&type=section&id=4.%20Company%20and%20Product%20Information) [About ProMIS Neurosciences Inc.](index=5&type=section&id=4.1%20About%20ProMIS%20Neurosciences%20Inc.) 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](index=9&type=chunk) - 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](index=9&type=chunk) [About PMN310](index=5&type=section&id=4.2%20About%20PMN310) 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](index=10&type=chunk) - PMN310 received **FDA Fast Track designation** in July 2025[10](index=10&type=chunk) [Forward-Looking Statements](index=5&type=section&id=5.%20Forward-Looking%20Statements) [Forward-Looking Statements](index=5&type=section&id=5.1%20Forward-Looking%20Statements) 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](index=11&type=chunk)[14](index=14&type=chunk) - 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](index=14&type=chunk) - 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](index=14&type=chunk) [Contact Information](index=7&type=section&id=6.%20Contact%20Information) [Contact Information](index=7&type=section&id=6.1%20Contact%20Information) 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](index=15&type=chunk) - Investor Relations Contact: **Kaytee Bock Zafereo (katherine.bock@promisneurosciences.com)**[15](index=15&type=chunk)

Core Insights - ProMIS Neurosciences has received Fast Track designation from the U.S. FDA for its Alzheimer's disease treatment candidate PMN310, enhancing its potential for priority review [2][11] - The PRECISE-AD Phase 1b trial for PMN310 is progressing well, with over 50% of the planned 128 patients enrolled, no cases of amyloid-related imaging abnormalities (ARIA) reported, and no patient dropouts [2][9] - The company has strengthened its financial position by raising approximately $21.6 million in gross proceeds in July 2025 [2][14] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing antibody therapeutics targeting toxic misfolded proteins associated with neurodegenerative diseases, including Alzheimer's disease, ALS, and Parkinson's disease [10] - The company's proprietary platform, EpiSelect™, is designed to identify conformational epitopes on toxic misfolded proteins, enabling the generation of selective therapeutic antibodies [4][10] Clinical Development - PMN310 is a humanized IgG1 monoclonal antibody specifically targeting toxic amyloid-beta oligomers (AβO), which are believed to be a major driver of Alzheimer's disease [5][11] - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, and pharmacokinetics of PMN310, with interim results expected in Q2 2026 and final results in Q4 2026 [12][9] Financial Performance - As of June 30, 2025, ProMIS reported cash and cash equivalents of $4.5 million, an increase from $1.0 million a year earlier [14] - Research and development expenses for Q2 2025 were $8.7 million, significantly higher than $1.6 million in the same period of 2024, primarily due to costs associated with the PRECISE-AD trial [14][20] - The net loss for Q2 2025 was $10.1 million, compared to a net loss of $2.6 million in Q2 2024, reflecting increased clinical trial expenditures [14][20]

Core Insights - ProMIS Neurosciences Inc. is advancing its Phase 1b clinical trial, PRECISE-AD, for PMN310, a therapeutic candidate targeting toxic oligomers in Alzheimer's Disease (AD) [2][6] - The company has received Fast Track designation from the FDA for PMN310, indicating its potential to address unmet medical needs in AD [2][10] - The ongoing trial has enrolled over 50% of the planned 128 patients, reflecting a swift enrollment process [2][7] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies for neurodegenerative diseases, including AD, ALS, and PD [8] - The company's proprietary platform, EpiSelect, identifies toxic misfolded proteins, enabling the design of selective therapeutic antibodies [3][8] Clinical Trial Details - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, and pharmacokinetics of PMN310 at multiple ascending doses [7] - The trial aims to evaluate the effects of PMN310 on biomarkers associated with AD pathology and clinical outcomes, with a primary focus on safety [6][7] - Interim data from the trial is expected to be reported in Q2 2026, with topline results anticipated by Q4 2026 [2][10] Presentation and Conference Participation - ProMIS Neurosciences will present its findings at the Alzheimer's Association International Conference 2025, highlighting the PRECISE-AD trial and the EpiSelect platform [1][4] - Key presentations will include discussions on the design and validation of the EpiSelect platform and the ongoing clinical trial [4][5]

Core Points - ProMIS Neurosciences, Inc. has announced a private investment in public equity (PIPE) financing, raising approximately $2.4 million through the issuance of warrants, with total gross proceeds expected to reach $9.2 million when including additional funds from existing warrant exercises [1][3] - The warrants have an exercise price of $1.25 per share, are immediately exercisable, and will expire five years from the date of issuance [2] - Proceeds from the PIPE financing will be utilized to advance the clinical development of PMN310, the company's lead therapeutic candidate, as well as for working capital and general corporate expenses [4] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies targeting toxic misfolded proteins associated with neurodegenerative diseases, including Alzheimer's disease, ALS, and Parkinson's disease [7] - The company employs a proprietary target discovery engine, EpiSelect™, to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are implicated in various neurodegenerative conditions [7]

Core Viewpoint - ProMIS Neurosciences Inc. has raised $0.8 million through the issuance of pre-funded warrants to an existing healthcare-focused institutional investor, aimed at advancing its clinical development of therapeutic antibodies for neurodegenerative diseases [1][3]. Group 1: Financial Details - The company issued pre-funded warrants to purchase 984,736 common shares at a price of $0.8124 per share, with a nominal exercise price of $0.0001 per share [2]. - The gross proceeds from this offering are expected to be approximately $0.8 million before deducting offering expenses [3]. - The closing of the offering is anticipated to occur around July 24, 2025, subject to customary closing conditions [2][3]. Group 2: Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies targeting toxic misfolded proteins associated with neurodegenerative diseases such as Alzheimer's disease, ALS, and Parkinson's disease [1][6]. - The company utilizes its proprietary target discovery engine, EpiSelect™, to identify Disease Specific Epitopes (DSEs) on misfolded proteins [6].

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]