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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 3, 2025
PROMIS NEUROSCIENCES INC.
(Exact name of registrant as specified in its charter)
| | | | |
Canada | | 001-41429 | | 98-0647155 |
(State or other jurisdiction
of incorporation) | | (Commission
File Number) | | (IRS Employer
Identification No.) |
| | | | |
Suite 200, 1920 Yonge Street,
Toronto, Ontario | | | | M4S 3E2 |
(Address of principal executive
offices) | | | | (Zip Code) |
Registrant’s telephone number, including area code: (416) 847-6898
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| | | | |
Title of Each Class | | Trading Symbol(s) | | Name of Each Exchange on Which Registered |
Common Shares, no par value per share | | PMN | | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter)
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On September 3, 2025, ProMIS Neurosciences Inc. (the “Company”) issued a press release (the “Press Release”) announcing that the independent Data and Safety Monitoring Board (“DSMB”) for its ongoing PRECISE-AD Phase 1b clinical trial has unanimously recommended that the Company proceed to the third and final dose escalation cohort in this trial of PMN310, the Company’s lead therapeutic candidate in development for the treatment of Alzheimer’s disease. A copy of the Press Release is attached hereto as Exhibit 99.1.
The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On September 3, 2025, the Company issued the Press Release announcing that the DSMB for its ongoing PRECISE-AD Phase 1b clinical trial has unanimously recommended that the Company proceed to the third and final dose escalation cohort in this trial of PMN310, the Company’s lead therapeutic candidate in development for the treatment of Alzheimer’s disease. The recommendation followed a review of available safety data through Cohort 2, which has now been fully enrolled, with no cases of amyloid-related imaging abnormalities observed to date. Enrollment of patients into Cohort 3 is now underway, keeping the Company on track to deliver 6-month interim data in the second quarter of 2026 and final top-line results in the fourth quarter of 2026.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| | |
Exhibit No. | | Description |
99.1 | | Press Release, dated September 3, 2025 |
104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| PROMIS NEUROSCIENCES INC. |
| | |
Date: September 3, 2025 | By: | /s/ Neil Warma |
| | Name: Neil Warma |
| | Title: Chief Executive Officer |
