ProMIS Neurosciences (PMN) - 2025 Q1 - Quarterly Report

PART I: FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements (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][30] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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][100] 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] - General and administrative expenses increased by $0.4 million (29%), largely due to $0.5 million in severance costs recognized in Q1 2025[122] - 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][131] Item 3. Quantitative and Qualitative Disclosures About Market Risk 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] - 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] - 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] Item 4. Controls and Procedures 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] - 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] - Remediation measures are underway, but the material weakness was not yet remediated as of the report date[151][152] PART II: OTHER INFORMATION Item 1. Legal Proceedings 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] Item 1A. Risk Factors 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] - Failure to obtain necessary additional financing could force the company to delay, limit, reduce, or terminate its development programs and commercialization efforts[157][160] - 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][162] Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities 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] Item 6. Exhibits 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]