Preclinical data showed strong antibody responses with no measurable pro-inflammatory T cell responses against AßO and support novel approach for potential Alzheimer's disease vaccine CAMBRIDGE, Massachusetts and TORONTO, Ontario, July 30, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer's disease (AD), amyotrophic late ...

CAMBRIDGE, Massachusetts and TORONTO, Ontario, July 26, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced positive top-line data from the first four cohorts of its first-in-human Phase 1a clinical trial of PMN310 in he ...

Topline results demonstrated a favorable safety profile and tolerability across four ascending dose levels in healthy volunteers and showed dose dependent levels of PMN310 antibody in Cerebrospinal fluid (CSF) suggestive of its potential for target engagement in Alzheimer's disease patients PMN310 builds on a large body of scientific evidence that points to the role of soluble amyloid-beta oligomers (AbO) as a primary driver of Alzheimer's pathology. By selectively targeting toxic oligomers, ProMIS seeks to ...

Proceeds expected to support Company beyond 6 month and 12 month data from the PMN310 Phase Ib study in Alzheimer's patients The PIPE financing included participation from new and existing healthcare specialist investors such as Great Point Partners, LLC, Armistice Capital, Ally Bridge Group, Sphera Healthcare, and other institutional and individual accredited investors. Proceeds from the PIPE financing are expected to be used to advance the clinical development of PMN310, ProMIS' lead therapeutic candidate ...

Table of Contents For the quarterly period ended March 31, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION OR Washington, D.C. 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Toronto, Ontario M4S 3E2 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: 416-847- ...

Exhibit 99.1 ProMIS Neurosciences Announces First Quarter 2024 Financial Results and Recent Highlights Top-line data from first-in-human Phase 1a clinical trial of PMN310 as a treatment for Alzheimer's disease on track for mid-2024 CAMBRIDGE, Massachusetts and TORONTO, Ontario – May 14, 2024 – ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission file number: 001-41429 PROMIS NEUROSCIENCES INC. (Exact name of registrant as specified in its charter) Ontario, Canada 98-0647155 (State of O ...

Exhibit 99.1 ProMIS Neurosciences Announces Full Year 2023 Financial Results and Recent Highlights Top-line Data from first-in-human Phase 1a clinical trial of PMN310 as a treatment for Alzheimer's disease on track for mid-2024 CAMBRIDGE, Massachusetts and TORONTO, Ontario – April 1, 2024 – ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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 September 30, 2023 Ontario, Canada 98-0647155 (State or other jurisdiction of incorporation or organization) Suite 200, 1920 Yonge Street (I.R.S. Employer Identification No.) Toronto, Ontario M4S 3E2 (Address of principal executive offices) (Zip Code) Registrant's telephone numbe ...

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The company's financial statements reflect a sharp cash decline, increased liabilities, and a growing net loss, raising going concern doubts [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets declined significantly due to decreased cash, while liabilities and the shareholders' deficit substantially increased Condensed Consolidated Balance Sheets (as of June 30, 2023 and December 31, 2022) | | June 30, 2023 (USD) | December 31, 2022 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash | $1,222,660 | $5,875,796 | | Total current assets | $1,479,224 | $6,903,487 | | Total assets | $1,498,068 | $6,924,646 | | **Liabilities and Shareholders' Deficit** | | | | Accounts payable | $7,963,108 | $2,975,398 | | Total current liabilities | $8,738,960 | $6,413,044 | | Total liabilities | $10,026,360 | $8,272,418 | | Total shareholders' deficit | $(8,528,292) | $(1,347,772) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss significantly increased due to a sharp decline in other income, despite a reduction in operating expenses Operating Results Comparison (Six Months Ended June 30) | | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Research and development | $4,515,967 | $5,132,416 | | General and administrative | $3,354,588 | $3,670,751 | | **Loss from operations** | **$(7,870,555)** | **$(8,803,167)** | | Total other income (expense), net | $599,150 | $3,963,284 | | **Net loss** | **$(7,271,405)** | **$(4,839,883)** | | Net loss per share, basic and diluted | $(0.85) | $(0.67) | Operating Results Comparison (Three Months Ended June 30) | | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Research and development | $1,005,715 | $3,229,584 | | General and administrative | $1,894,169 | $1,635,065 | | **Loss from operations** | **$(2,899,884)** | **$(4,864,649)** | | **Net loss** | **$(2,311,974)** | **$(2,745,038)** | | Net loss per share, basic and diluted | $(0.27) | $(0.38) | [Condensed Consolidated Statements of Changes in Shareholders' Equity (Deficit)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity%20(Deficit)) Shareholders' deficit significantly expanded, primarily driven by the net loss and foreign currency translation adjustments Changes in Shareholders' Deficit (For the Six Months Ended June 30, 2023) | Description | Amount (USD) | | :--- | :--- | | Balance, January 1, 2023 | $(1,347,772) | | Share-based compensation | $266,701 | | Foreign currency translation | $(175,816) | | Net loss | $(7,271,405) | | **Balance, June 30, 2023** | **$(8,528,292)** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations improved, yet the overall cash balance significantly decreased with no investing or financing activities Cash Flow Summary (Six Months Ended June 30) | | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,708,976) | $(7,844,557) | | Net cash used in investing activities | $— | $(2,048) | | Net decrease in cash | $(4,653,136) | $(8,040,129) | | **Cash at end of period** | **$1,222,660** | **$8,903,776** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's business focus, significant going concern doubt, accounting policies, equity, and R&D commitments - The company is focused on developing antibody therapies for neurodegenerative diseases, including Alzheimer's (AD), multiple system atrophy (MSA), and amyotrophic lateral sclerosis (ALS), using its proprietary technology platform[29](index=29&type=chunk) - Management has identified conditions that raise substantial doubt about the Company's ability to continue as a going concern. The company had a net loss of **$7.3 million** for the six months ended June 30, 2023, and an accumulated deficit of **$87.5 million**. Additional funding is required to continue operations[34](index=34&type=chunk) - In May 2023, the Company entered into an agreement with a vendor to defer payment on approximately **$5.3 million** of current accounts payable and accrued liabilities until March 31, 2024, with interest accruing at **5.5%** annually[50](index=50&type=chunk) - Subsequent to the quarter end, in July 2023, the company voluntarily delisted from the Toronto Stock Exchange (TSX) to consolidate its shares on Nasdaq and re-domiciled from federal Canadian jurisdiction to the Province of Ontario[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's neurodegenerative disease focus, significant losses, insufficient cash for 12 months, and dependence on future funding - The company's lead product candidate is PMN310 for Alzheimer's Disease. An Investigational New Drug (IND) application was filed with the FDA in April 2023 and cleared in May 2023. A Phase 1a clinical trial is planned, contingent on securing sufficient funding[85](index=85&type=chunk)[91](index=91&type=chunk) - The company's cash of **$1.2 million** as of June 30, 2023, is not sufficient to fund operating expenses for at least 12 months, raising substantial doubt about its ability to continue as a going concern[90](index=90&type=chunk)[116](index=116&type=chunk) R&D Expenses by Program (Six Months Ended June 30) | Program | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | PMN310 | $2,603,786 | $2,835,605 | | ALS | $— | $404,058 | | Platform and other programs | $298,915 | $308,030 | | **Total R&D Expenses** | **$4,515,967** | **$5,132,416** | General & Administrative Expenses (Six Months Ended June 30) | Category | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Professional and consulting fees | $2,573,814 | $2,807,125 | | Employee salaries and benefits | $421,933 | $378,770 | | Share-based compensation | $188,683 | $141,273 | | **Total G&A Expenses** | **$3,354,588** | **$3,670,751** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces significant liquidity and foreign currency exchange risks, with a 10% USD change impacting net loss by $0.8 million - The company's primary market risk is foreign currency exchange risk, as its functional currency is the Canadian dollar (C$) but it holds U.S. dollar (US$) denominated cash and liabilities[130](index=130&type=chunk) - As of June 30, 2023, a **10%** change in the USD exchange rate would impact the net loss by approximately **$0.8 million**[130](index=130&type=chunk) - Liquidity risk is a major concern, as the company is pre-revenue and depends on external fundraising to support operations and meet commitments[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective with no material changes to internal control over financial reporting - Management concluded that as of June 30, 2023, the company's disclosure controls and procedures were effective[133](index=133&type=chunk) - There were no material changes in the company's internal control over financial reporting during the quarter ended June 30, 2023[134](index=134&type=chunk) [PART II - OTHER INFORMATION](index=30&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[136](index=136&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) Primary risk is financial viability, with substantial doubt about going concern due to recurring losses and need for additional funding - The company has incurred losses since inception and expects them to continue, raising substantial doubt about its ability to continue as a going concern[138](index=138&type=chunk) - The company had negative working capital of approximately **($7.3) million** as of June 30, 2023, and will require substantial additional funds for R&D, clinical testing, and regulatory approvals[139](index=139&type=chunk) - A failure to obtain necessary capital could force the company to delay, limit, reduce, or terminate its development programs and commercialization efforts[138](index=138&type=chunk)[140](index=140&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the period - None[141](index=141&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the period - None[142](index=142&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[143](index=143&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) No other information to report for the period - None[143](index=143&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report, including CEO/CFO certifications and XBRL data - Exhibits filed include CEO and CFO certifications (**31.1, 31.2, 32.1**) and Inline XBRL documents (**101 series**)[145](index=145&type=chunk)