ProMIS Neurosciences Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001558370-25-011299
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001104659-25-109719
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 84 previous paragraphs and 83 current paragraphs.
60 unchanged; 18 reworded; 4 added; 6 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 16 previous and 16 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (4)
Current report
Nine Months Ended September 30, 2025 and 2024
Current report
Other income decreased by $13.5 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was primarily due to a decrease in the gain on change in fair value of financial instruments of $17.0 million, offset by a 2024 loss on the issuance of Common Shares, warrants, and pre-funded warrants in our July 2024 PIPE of $3.5 million.
Current report
Other income decreased by $13.5 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease was primarily due to a decrease in the gain on change in fair value of financial instruments of $17.0 million, offset by a 2024 loss on the issuance of Common Shares, warrants, and pre-funded warrants in our July 2024 PIPE of $3.5 million.
Current report
In August 2025, we filed a shelf registration statement with the SEC. In conjunction with the shelf registration, we entered into an At The Market Offering Agreement with H.C. Wainwright & Co., LLC (the “2025 ATM Agreement”) to offer up to $18.0 million of our Common Shares. During the three and nine months ended September 30, 2025, we sold 1,019,877 Common Shares for net proceeds of $0.7 million, after deducting sales commissions.
Removed paragraphs (6)
Previous report
Six Months Ended June 30, 2025 and 2024
Previous report
Interest expense decreased by $0.1 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024, offset by a reduction in the gain on change in fair value of financial instruments.
Previous report
Gain on change in fair value of financial instruments decreased by $0.1 million during the three months ended June 30, 2025 compared to the three months ended June 30, 2024, offset by an increase in interest income.
Previous report
On July 22, 2025, we entered into a securities purchase agreement (the “Purchase Agreement”) relating to the issuance and sale of a Pre-funded warrant to purchase 984,736 Common Shares (the “Pre-funded Warrant”) to such investor (the “RD Offering”). The Pre-
Previous report
On July 22, 2025, we entered into a securities purchase agreement (the “July 22, 2025 PIPE Purchase Agreement”) to raise $2.4 million in aggregate gross proceeds (the “July 22, 2025 PIPE Offering”). Fees and other expenses are currently not estimable by us, as they are still being determined. Pursuant to the terms of the July 22, 2025 PIPE Purchase Agreement, we agreed to sell a warrant to purchase 12,616,821 Common Shares (the “July 22, 2025 Warrant”). The July 22, 2025 Warrant was sold to the investor at an offering price of $0.1875 per share and has an exercise price of $1.25 per share and is immediately exercisable for a period of five years after the date of issuance.
Previous report
On July 29, 2025, we entered into a securities purchase agreement (the “July 29, 2025 PIPE Purchase Agreement”) to raise $3.0 million in aggregate gross proceeds (the “July 29, 2025 PIPE Offering”). Fees and other expenses are currently not estimable by us, as they are still being determined. Pursuant to the terms of the July 29, 2025 PIPE Purchase Agreement, we agreed to sell a warrant to purchase 15,616,360 Common Shares (the “July 29, 2025 Warrant”). The July 29, 2025 Warrant was sold to investors at an offering price of $0.1875 per share and have an exercise price of $1.25 per share, and are immediately exercisable for a period of five years after the date of issuance.
Reworded paragraphs (18)
Previous wording
All references in this management’s discussion and analysis of financial condition and results of operations, or MD&A, to the “Company”, “ProMIS”, “we”, “us”, or “our” refer to ProMIS Neurosciences Inc., unless otherwise indicated or the context requires otherwise. The following MD&A is prepared as of August 13, 2025 for the three and six months ended June 30, 2025 and should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2024 and 2023 included in the Company’s Annual Report on Form 10-K and the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2025 and 2024 included in this Quarterly Report on Form 10-Q (collectively, the “Financial Statements”), which have been prepared by management in accordance with GAAP as issued by the FASB. All dollar amounts refer to United States dollars, except as stated otherwise.
Current wording
All references in this management’s discussion and analysis of financial condition and results of operations, or MD&A, to the “Company”, “ProMIS”, “we”, “us”, or “our” refer to ProMIS Neurosciences Inc., unless otherwise indicated or the context requires otherwise. The following MD&A is prepared as of November 10, 2025 for the three and nine months ended September 30, 2025 and should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2024 and 2023 included in the Company’s Annual Report on Form 10-K and the unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2025 and 2024 included in this Quarterly Report on Form 10-Q (collectively, the “Financial Statements”), which have been prepared by management in accordance with GAAP as issued by the FASB. All dollar amounts refer to United States dollars, except as stated otherwise.
Previous wording
We have incurred significant operating losses since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual licensing and/or commercialization of our product candidates and any future product candidates. Our net losses were $10.1 million and $2.6 million for the three months ended June 30, 2025 and 2024, respectively, and $17.5 million and $6.3 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $108.2 million. We had negative cash flows from operations of $8.8 million for the six months ended June 30, 2025. We expect to continue to incur net losses for the foreseeable future and, if able to raise additional funding, would expect our research and development expenses, general and administrative expenses and capital expenditures to increase. In particular, if we are able to raise additional funding, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as initiate clinical trials, hire additional personnel, pay fees to outside consultants, lawyers and accountants, and incur other increased costs associated with being a clinical-stage public company. In addition, if we obtain marketing approval for any product candidates, we may incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We may also incur expenses should we in-license or acquire additional product candidates.
Current wording
In July 2025, we received gross proceeds of $21.6 million from discounted warrant exercises, the sale of additional warrants in private placements, and the sale of pre-funded warrants to purchase Common Shares in a registered direct offering, less transaction costs of $1.4 million. Refer to additional discussion in Note 6. However, we expect to continue to incur net losses for the foreseeable future and, if able to raise additional funding, would expect our research and development expenses, general and administrative expenses and capital expenditures to increase. In particular, if we are able to raise additional funding, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as initiate clinical trials, hire additional personnel, pay fees to outside consultants, lawyers and accountants, and incur other increased costs associated with being a clinical-stage public company. In addition, if we obtain marketing approval for any product candidates, we may incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We may also incur expenses should we in-license or acquire additional product candidates.
Previous wording
We expect that our cash of $4.5 million as of June 30, 2025, as well as the aggregate gross proceeds of $21.6 million we received in July 2025, will not be sufficient to fund the Company’s operating expenses for at least 12 months from the date these Financial Statements were issued. This raises substantial about regarding our ability to continue as a going concern. Refer to additional discussion related to going concern considerations in “Liquidity and Capital Resources.”
Current wording
We expect that our cash of $15.4 million as of September 30, 2025 will not be sufficient to fund the Company’s operating expenses for at least 12 months from the date these Financial Statements were issued. This raises substantial about regarding our ability to continue as a going concern. Refer to additional discussion related to going concern considerations in “Liquidity and Capital Resources.”
Previous wording
As of August 13, 2025, we have enrolled all of Cohort 1 and are well into Cohort 2 (greater than 50% of the total planned patient enrollment for the trial). To date, we have not observed any cases of ARIA, including brain swelling or microhemorrhages. In addition, on July 21, 2025, we announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to** **PMN310, which we believe recognizes the potential of this program to address an unmet medical need in AD. We anticipate reporting six-month interim data from the study in the second quarter of 2026, with topline results expected in the fourth quarter of 2026.
Current wording
As of November 12, 2025, we have enrolled all of Cohorts 1 and 2 and are well into Cohort 3, with complete enrollment expected before the end of the year and a continued favorable safety profile. We also announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to** **PMN310, which we believe recognizes the potential of this program to address an unmet medical need in AD. We anticipate reporting six-month interim data from the study in the second quarter of 2026, with topline results expected in the fourth quarter of 2026.
Previous wording
Expenditures for PMN310 in the three and six months ended June 30, 2025, were approximately $8.1 million and $12.8 million, respectively, not including allocations of senior management time.
Current wording
Expenditures for PMN310 in the three and nine months ended September 30, 2025, were approximately $8.8 million and $21.5 million, respectively, not including allocations of senior management time.
Previous wording
Research and development expenses increased by $10.5 million, or 284%, for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This increase is largely attributable to a $10.2 million increase in direct research and development expenses related to the PMN310 phase 1b trial, which commenced in late 2024 and is ongoing in 2025. Employee salary and benefit, share-based compensation, and consulting costs also increased by $0.1 million each.
Current wording
Research and development expenses increased by $17.7 million, or 280%, for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This increase is largely attributable to a $17.0 million increase in direct research and development expenses related to the PMN310 phase 1b trial, which commenced in late 2024 and is ongoing in 2025. Employee salary and benefits increased by $0.5 million in 2025. Share-based compensation and consulting costs also increased by $0.1 million each.
Previous wording
General and administrative expenses increased by $0.8 million, or 31%, for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. Employee salaries and benefits increased by $0.8 million due to the recognition of $0.5 million in severance costs during the six months ended June 30, 2025 and the hiring of additional employees in 2025. Professional and consulting fees decreased by $0.5 million, primarily driven by a decrease of $0.3 million in legal fees, $0.2 million in investor and shareholder relations costs, and $0.1 million in audit and tax fees, offset by an increase of $0.1 million in recruiting costs. Share-based compensation expense increased by $0.3 million. Facility-related and other costs increased by $0.2 million.
Current wording
General and administrative expenses increased by $0.9 million, or 31%, for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. Employee salaries and benefits increased by $0.9 million due to the recognition of $0.5 million in severance costs during the nine months ended September 30, 2025 and the hiring of additional employees in 2025. Professional and consulting fees decreased by $0.5 million, primarily driven by a decrease of $0.3 million in investor and shareholder relations costs, $0.2 million in insurance costs, and $0.1 million in legal fees, offset by an increase of $0.1 million in recruiting costs. Share-based compensation expense increased by $0.3 million. Facility-related and other costs increased by $0.2 million.
Previous wording
Research and development expenses increased by $7.1 million, or 438%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This increase is largely attributable to a $7.0 million increase in direct research and development expenses related to the PMN310 phase 1b trial, which commenced in late 2024 and is ongoing in 2025. Employee salary and benefit costs also increased by $0.1 million.
Current wording
Research and development expenses increased by $7.2 million, or 282%, for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. This increase is largely attributable to a $6.9 million increase in direct research and development expenses related to the PMN310 phase 1b trial, which commenced in late 2024 and is ongoing in 2025. Employee salary and benefit costs also increased by $0.3 million.
Previous wording
General and administrative expenses increased by $0.3 million, or 32%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. Employee salaries and benefits and share-based compensation each increased by $0.2 million due to additional employees in 2025. Patent expense decreased by $0.1 million.
Current wording
General and administrative expenses increased by $0.1 million, or 4%, for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. Employee salaries and benefits increased by $0.1 million due to additional employees in 2025. Professional and consulting fees decreased by $0.1 million due to a $0.2 million decrease in legal fees, offset by a $0.1 million increase in audit and tax fees.
Previous wording
On September 22, 2023, we filed a registration statement on Form S-3 (File No. 333-274658) with the SEC, which was declared effective on September 29, 2023 (Shelf Registration Statement), in relation to the registration of Common Shares, preferred shares, subscription receipts, debt securities, warrants and/or units of any combination thereof for the purposes of selling, from time to time, our Common Shares, debt securities or other equity securities in one or more offerings. On January 5, 2024, we entered into an At The Market Offering Agreement with BTIG, LLC (the “ATM Agreement”) to provide for the offering, issuance and sale of up to an aggregate amount of $25.0 million of our Common Shares from time to time in “at-the-market” offerings under the Shelf Registration Statement and subject to the limitations thereof, including limitations related to the amount we are able to sell pursuant to such ATM Agreement based on our public float as of a measuring date preceding the filing of our Annual Report. During the year ended December 31, 2024 we sold 75,862 shares for net proceeds of approximately $0.2 million. No shares have been sold in the six months ended June 30, 2025, and the ATM Agreement was terminated on July 21, 2025.
Current wording
On September 22, 2023, we filed a registration statement on Form S-3 (File No. 333-274658) with the SEC, which was declared effective on September 29, 2023 (Shelf Registration Statement), in relation to the registration of Common Shares, preferred shares, subscription receipts, debt securities, warrants and/or units of any combination thereof for the purposes of selling, from time to time, our Common Shares, debt securities or other equity securities in one or more offerings. On January 5, 2024, we entered into an At The Market Offering Agreement with BTIG, LLC (the “2023 ATM Agreement”) to provide for the offering, issuance and sale of up to an aggregate amount of $25.0 million of our Common Shares from time to time in “at-the-market” offerings under the Shelf Registration Statement and subject to the limitations thereof, including limitations related to the amount we are able to sell pursuant to such 2023 ATM Agreement based on our public float as of a measuring date preceding the filing of our Annual Report. During the year ended December 31, 2024 we sold 75,862 shares for net proceeds of approximately $0.2 million. We did not sell any Common Shares in 2025 pursuant to the 2023 ATM Agreement and the 2023 ATM Agreement was terminated in July 2025.
Previous wording
funded Warrant was sold at an offering price of $0.8124 per share, which represents, if it were applicable, the per share offering price for the Common Shares, less a $0.0001 per share exercise price for such Pre-funded Warrant. The gross proceeds from the RD Offering were approximately $0.8 million. Offering expenses are currently not estimable by us, as they are still being determined.
Current wording
On July 22, 2025, we entered into a securities purchase agreement to issue and sell pre-funded warrants to purchase 984,736 Common Shares (the “RD Offering”). The RD Offering pre-funded warrant was sold at an offering price of $0.8124 per share, which represents, if it were applicable, the per share offering price for the Common Shares of the Company, less a $0.0001 per share exercise price for such Pre-funded Warrant. The gross proceeds from the RD Offering were $0.8 million before deducting offering expenses of $0.1 million.
Previous wording
In July 2025, we accepted discounted exercise offers for 18,822,120 Common Share warrants, distributed ratably amongst the Tranche A, B, and C Warrants, from the July 2024 PIPE for aggregate gross proceeds of approximately $15.9 million. Fees and other expenses are currently not estimable by us, as they are still being determined.
Current wording
Additionally, in July 2025, across multiple transactions dated July 22 and 28, 2025, we accepted discounted exercise offers for 18,822,120 Common Share warrants, distributed ratably amongst the Tranche A, B, and C Warrants from the July 2024 PIPE for aggregate gross proceeds of approximately $15.5 million and sold 28,233,180 new warrants in two private placements for aggregate gross proceeds of $5.3 million. The total aggregate gross proceeds across the RD Offering, discounted warrant exercises, and sales of new warrants was $21.6 million, before deducting fees and offering expenses of $1.4 million.
Previous wording
We incurred a net loss of $10.1 million and $17.5 million for the three and six months ended June 30, 2025, respectively. We reported an accumulated deficit of $108.2 million as of June 30, 2025, and had negative cash flows from operations of $8.8 million for the six months ended June 30, 2025. Management believes that, despite the funding we received in July 2025, these conditions raise substantial doubt as to the Company’s ability to continue as a going concern within 12 months of the date the Financial Statements are issued. Additional funding will be necessary to fund future clinical activities and to pay down our existing liabilities. We will seek additional funding through public and private financings, debt financings, collaboration agreements, strategic alliances and licensing agreements. Although we have been successful in raising capital in the past, changing macroeconomic factors including, but not limited to, rising interest rates, uncertainties in the banking industry and inflation have diminished certain opportunities to obtain funding in the current market environment. There is no assurance of success in obtaining such additional financing on terms acceptable to us, if at all, and there is no assurance that we will be able to enter into collaborations or other arrangements. If we are unable to obtain funding, it could force us to delay, reduce or eliminate research and development programs and product portfolio expansion or commercialization efforts. These potential delays, reductions and eliminations could adversely affect future business prospects, and our ability to continue as a going concern.
Current wording
We incurred a net loss of $11.8 million and $29.4 million for the three and nine months ended September 30, 2025, respectively. We reported an accumulated deficit of $119.7 million as of September 30, 2025, and had negative cash flows from operations of $18.8 million for the nine months ended September 30, 2025. Management believes that these conditions raise substantial doubt as to the Company’s ability to continue as a going concern within 12 months of the date the Financial Statements are issued. Additional funding will be necessary to fund future clinical activities and to pay down our existing liabilities. We will seek additional funding through public and private financings, debt financings, collaboration agreements, strategic alliances and licensing agreements. Although we have been successful in raising capital in the past, changing macroeconomic factors including, but not limited to, rising interest rates, uncertainties in the banking industry and inflation have diminished certain opportunities to obtain funding in the current market environment. There is no assurance of success in obtaining such additional financing on terms acceptable to us, if at all, and there is no assurance that we will be able to enter into collaborations or other arrangements. If we are unable to obtain funding, it could force us to delay, reduce or eliminate research and development programs and product portfolio expansion or commercialization efforts. These potential delays, reductions and eliminations could adversely affect future business prospects, and our ability to continue as a going concern.
Previous wording
Cash used in operating activities was $8.8 million for the six months ended June 30, 2025, which consisted of a net loss of $17.5 million, decreased by share-based compensation of $0.5 million and a net change of $8.2 million in our operating assets and liabilities. Changes in cash flows related to operating assets and liabilities primarily consisted of an increase of $6.6 million of accrued liabilities, an increase of $1.0 million of accounts payable, and a decrease of $0.6 million of prepaid expenses.
Current wording
Cash used in operating activities was $18.8 million for the nine months ended September 30, 2025, which consisted of a net loss of $29.0 million, decreased by share-based compensation of $0.7 million and a net change of $9.6 million in our operating assets and liabilities. Changes in cash flows related to operating assets and liabilities primarily consisted of an increase of $7.5 million of accrued liabilities, an increase of $2.5 million of accounts payable, and an increase of $0.4 million in prepaid expenses and other current assets.
Previous wording
Cash used in operating activities was $11.8 million for the six months ended June 30, 2024, which consisted of a net loss of $6.3 million, increased by a net change of $5.5 million in our operating assets and liabilities. Changes in cash flows related to operating assets and liabilities primarily consisted of a decrease of $5.8 million of accounts payable, including a repayment of $5.9 million on previously deferred accounts payable, and a $0.3 million decrease of accrued liabilities, offset by a decrease of $0.6 million of prepaid expenses.
Current wording
Cash used in operating activities was $18.5 million for the nine months ended September 30, 2024, which consisted ofnet income of $3.0 million, decreased by non-cash activities of $13.3 million and a net change of $8.2 million in our operating assets and liabilities. Non-cash decreases included gains of $17.0 million on the change in the fair value of our financial instruments, offset by a non-cash loss of $3.5 million on the issuance of our Common Shares, warrants and pre-funded warrants in the July 2024 PIPE, and $0.2 million of share-based compensation. Changes in cash flows related to operating assets and liabilities primarily consisted of a decrease of $6.3 million of accounts payable, including a repayment of $5.9 million on previously deferred accounts payable, a $0.4 million decrease in accrued liabilities, and a $1.5 million increase in prepaid expenses and other current assets.
Previous wording
There was no cash used in investing activities during the six months ended June 30, 2025 or 2024.
Current wording
There was no cash used in investing activities during the nine months ended September 30, 2025 or 2024.
Previous wording
There was no cash provided by financing activities during the six months ended June 30, 2025.
Current wording
Cash provided by financing activities during the nine months ended September 30, 2025 was $20.9 million, which included $8.4 million from the July 22, 2025 Discounted Exercise (as detailed in our notes to the financial statements) and PIPE Purchase, $11.1 million from the July 29, 2025 Discounted Exercise (as detailed in our notes to the financial statements) and PIPE Purchase, $0.7 million from the sale of Common Shares under the At The Market Offering Agreement, and $0.7 million from the issuance of pre-funded warrants in the July 22, 2025 RD Offering.
Previous wording
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.
Current wording
Cash provided by financing activities during the nine months ended September 30, 2024 was $27.4 million, which included $27.2 million from the common shares, warrants and pre-funded warrants sold in the July 2024 PIPE, which does not include a subscription receivable of an additional $0.5 million, which was received in November 2024, and $0.2 million from the sale of Common Shares under the At The Market Offering Agreement (all amounts net of issuance costs).
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
We have incurred significant operating losses since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual licensing and/or commercialization of our product candidates and any future product candidates. Our operating losses were $11.8 million and $4.4 million for the three months ended September 30, 2025 and 2024, respectively, and $29.4 million and $10.8 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $119.7 million. We had negative cash flows from operations of $18.8 million for the nine months ended September 30, 2025.