ProMIS Neurosciences Files 8-K

TL;DR

ProMIS Neurosciences filed an 8-K on Jan 10, 2025, covering regulatory disclosures and other corporate events.

AI Summary

ProMIS Neurosciences Inc. filed an 8-K on January 10, 2025, reporting on various events. The filing includes information related to Regulation FD disclosures, other events, and financial statements and exhibits. The company, formerly known as Amorfix Life Sciences Ltd., is incorporated in Canada and headquartered in Toronto.

Why It Matters

This 8-K filing provides updates on ProMIS Neurosciences' corporate activities and regulatory disclosures, which are important for investors to monitor the company's compliance and operational status.

Risk Assessment

Risk Level: low — This filing is a routine corporate disclosure and does not appear to contain significant new risks or material adverse information.

Key Numbers

• 001-41429 — SEC File Number (Identifies the company's filing with the SEC)
• 98-0647155 — IRS Employer Identification No. (Tax identification number for the company)

Key Players & Entities

• ProMIS Neurosciences Inc. (company) — Registrant
• Amorfix Life Sciences Ltd. (company) — Former company name
• January 10, 2025 (date) — Date of earliest event reported
• Toronto, Ontario (location) — Principal executive offices location

FAQ

Filing Documents

• pmn-20250110x8k.htm (8-K) — 40KB
• pmn-20250110xex99d1.htm (EX-99.1) — 22KB
• pmn-20250110xex99d1002.jpg (GRAPHIC) — 4KB
• 0001558370-25-000095.txt ( ) — 207KB
• pmn-20250110.xsd (EX-101.SCH) — 4KB
• pmn-20250110_def.xml (EX-101.DEF) — 3KB
• pmn-20250110_lab.xml (EX-101.LAB) — 17KB
• pmn-20250110_pre.xml (EX-101.PRE) — 12KB
• pmn-20250110x8k_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On January 10, 2025, ProMIS Neurosciences Inc. (the "Company") issued a press release (the "Press Release") announcing the initiation of its Phase 1b clinical trial (PRECISE-AD) evaluating its lead therapeutic candidate, PMN310, in Alzheimer's disease ("AD"). 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.

01 Other Events

Item 8.01 Other Events. On January 10, 2025, the Company issued the Press Release announcing the initiation of its Phase 1b clinical trial (PRECISE-AD) evaluating its lead therapeutic candidate, PMN310, in AD. The ongoing Phase 1b PRECISE-AD trial will assess the safety, tolerability, and pharmacokinetics of PMN310 over 12 months of treatment in 100 patients with mild cognitive impairment due to AD (Stage 3 AD) or early AD (Stage 4 AD). The study will also evaluate key biomarkers and clinical measures of efficacy to gather data on PMN310's therapeutic potential. Results from the recently completed Phase 1a study in healthy volunteers demonstrated a generally favorable safety and tolerability profile, with drug concentrations in cerebrospinal fluid supporting its potential for robust target engagement in patients with AD. The Company anticipates reporting certain interim data in the first half of 2026.

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Certain information in this Current Report on Form 8-K constitutes forward-looking statements and forward-looking information (collectively, "forward-looking information") within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as "plans", "excited to", "targets", "expects" or "does not expect", "is expected", "an opportunity exists", "is positioned", "estimates", "intends", "assumes", "anticipates" or "does not anticipate" or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might", "will" or "will be taken", "occur" or "be achieved". In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Specifically, this Current Report on Form 8-K contains forward-looking information relating to the Company's plans and expectations for the Phase 1b study of PMN310. Statements containing forward-looking information are not historical facts but instead represent management's current expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this Current Report on Form 8-K, are subject to known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different fr

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated January 10, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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. PROMIS NEUROSCIENCES INC. Date: January 10, 2025 By: /s/ Neil Warma Name: Neil Warma Title: Chief Executive Officer