ProMIS Neurosciences (PMN) - 2025 Q3 - Quarterly Report

Financial Performance - Operating losses for the three months ended September 30, 2025, were $11.8 million, compared to $4.4 million for the same period in 2024, and for the nine months ended September 30, 2025, losses were $29.4 million, up from $10.8 million in 2024[112]. - The net loss for the nine months ended September 30, 2025, was $29.0 million, compared to a net income of $3.0 million in the same period of 2024, representing a decrease of $32.1 million[134]. - The net loss for the three months ended September 30, 2025, was $11.6 million, compared to a net income of $9.3 million in the same period of 2024, representing a decrease of $20.9 million[140]. - Other income decreased by $13.5 million for the nine months ended September 30, 2025, primarily due to a $17.0 million decrease in the gain on change in fair value of financial instruments[139]. Cash Flow and Funding - As of September 30, 2025, the accumulated deficit reached $119.7 million, with negative cash flows from operations of $18.8 million for the nine months ended September 30, 2025[112]. - The company expects cash of $15.4 million as of September 30, 2025, will not be sufficient to fund operations for at least 12 months, raising concerns about its ability to continue as a going concern[116]. - Cash provided by financing activities was $20.9 million for the nine months ended September 30, 2025, a decrease of $6.5 million compared to $27.4 million in the same period of 2024[158][159]. - The company reported a net increase in cash of $2.1 million for the nine months ended September 30, 2025, down from $8.9 million in the prior year[154]. - The company plans to seek additional funding through public and private financings, debt financings, collaboration agreements, strategic alliances, and licensing agreements to support future clinical activities[153]. Research and Development - PMN310, the lead product candidate, successfully completed its Phase 1a clinical trial and commenced the Phase 1b clinical trial ("PRECISE-AD") in December 2024, with plans to enroll approximately 100 subjects[116][117]. - Expenditures for PMN310 in the three and nine months ended September 30, 2025, were approximately $8.8 million and $21.5 million, respectively[120]. - PMN267, targeting ALS, is ready to progress to IND-enabling studies, subject to sufficient resources[121]. - PMN442, aimed at MSA and other synucleinopathies, has been humanized and is also ready for IND-enabling studies, pending resource availability[122]. - Research and development expenses increased by $17.7 million, or 280%, for the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to a $17.0 million increase related to the PMN310 phase 1b trial[135]. - For the three months ended September 30, 2025, research and development expenses increased by $7.2 million, or 282%, compared to the same period in 2024, largely due to a $6.9 million increase related to the PMN310 trial[141]. Administrative Expenses - General and administrative expenses rose by $0.9 million, or 31%, for the nine months ended September 30, 2025, driven by a $0.5 million increase in employee salaries and benefits[138]. - General and administrative expenses for the three months ended September 30, 2025, increased by $0.1 million, or 4%, compared to the same period in 2024[142]. Shareholder Information - As of September 30, 2025, the total number of issued and outstanding Common Shares and Common Share Equivalents was 124,602,290[166]. - The company sold 1,019,877 Common Shares for net proceeds of $0.7 million during the three and nine months ended September 30, 2025[147]. - The company completed a private placement in July 2024 for aggregate gross proceeds of $30.3 million, selling 9,757,669 common share units at $2.15 each[148]. - The total aggregate gross proceeds from various offerings in July 2025 amounted to $21.6 million before deducting fees and offering expenses[152]. Liquidity and Risk - The company faces liquidity risk as a pre-revenue development stage company, relying on external fundraising to support operations[169]. - The company experienced a significant increase in accrued liabilities by $7.5 million and accounts payable by $2.5 million during the nine months ended September 30, 2025[155]. - There were no cash flows used in investing activities during the nine months ended September 30, 2025 or 2024[157]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay adopting new accounting standards[164].