ProMIS advances PMN310 Alzheimer’s trial to final dose

Rhea-AI Filing Summary

ProMIS Neurosciences Inc. reported that an independent Data and Safety Monitoring Board for its ongoing PRECISE-AD Phase 1b trial has unanimously recommended proceeding to the third and final dose-escalation cohort of PMN310, its lead therapeutic candidate for Alzheimer’s disease. The recommendation followed a review of safety data through Cohort 2, which is now fully enrolled, with no cases of amyloid-related imaging abnormalities observed so far.

The company has begun enrolling patients in Cohort 3 and remains on track to report 6‑month interim data in the second quarter of 2026 and final top-line results in the fourth quarter of 2026, according to the disclosure.

Positive

• DSMB unanimously backs escalation to final dose cohort, with no amyloid-related imaging abnormalities observed through fully enrolled Cohort 2, supporting continued development of PMN310 in Alzheimer’s disease.

Negative

• None.

Insights

Biotech clinical development analyst

Safety-cleared dose escalation keeps PMN310 Alzheimer’s trial on schedule.

The unanimous recommendation by the independent DSMB to advance ProMIS Neurosciences’ PRECISE-AD Phase 1b trial of PMN310 into the third and final dose cohort indicates that available safety data from Cohort 2 were acceptable. The disclosure highlights that no amyloid-related imaging abnormalities were observed to date through this cohort, an important safety consideration for amyloid-targeting Alzheimer’s therapies.

The company states that enrollment in Cohort 3 is underway and that it remains 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. For early-stage neuroscience programs, staying on the planned timeline and clearing safety reviews can be meaningful, though ultimate outcomes will depend on the efficacy and longer-term safety data once available.

8-K Event Classification

2 items: 7.01, 8.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did ProMIS Neurosciences (PMN) announce in this 8-K?

The company announced that the independent Data and Safety Monitoring Board for its PRECISE-AD Phase 1b trial unanimously recommended proceeding to the third and final dose escalation cohort of PMN310, its lead Alzheimer’s disease candidate.

What is PMN310 in the ProMIS Neurosciences (PMN) filing?

PMN310 is ProMIS Neurosciences’ lead therapeutic candidate in development for the treatment of Alzheimer’s disease, currently being tested in the PRECISE-AD Phase 1b clinical trial.

What did the safety review show in the PRECISE-AD Phase 1b trial?

After reviewing safety data through Cohort 2, which is fully enrolled, the DSMB recommended moving to Cohort 3, and the company reported no cases of amyloid-related imaging abnormalities observed to date.

What are the next milestones for ProMIS Neurosciences’ PMN310 trial?

Enrollment in Cohort 3 is underway, and the company expects to report 6‑month interim data in Q2 2026 and final top-line results in Q4 2026 for the PRECISE-AD Phase 1b trial.

How far along is the PRECISE-AD Phase 1b trial for PMN310?

The trial has completed enrollment for Cohort 2, the DSMB has recommended advancing to the third and final dose escalation cohort, and patient enrollment into Cohort 3 has begun.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 09/03/2025 - 07:05 AM Learn about SEC filing dates

0001374339false00013743392025-09-032025-09-03

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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)

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Canada		001-41429		98-0647155
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

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Suite 200, 1920 Yonge Street, Toronto, Ontario				M4S 3E2
(Address of principal executive offices)				(Zip Code)

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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

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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. ☐

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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.

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Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

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Exhibit No.		Description
99.1	​	Press Release, dated September 3, 2025
104	​	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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.
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Date: September 3, 2025	By:	/s/ Neil Warma
​	​	Name: Neil Warma
​	​	Title: Chief Executive Officer

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