ProMIS Neurosciences Files 8-K Report

TL;DR

PMN filed an 8-K, likely with financial updates. Keep an eye out.

AI Summary

On July 26, 2024, ProMIS Neurosciences Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or material events were detailed in the provided excerpt.

Why It Matters

This filing indicates ProMIS Neurosciences is providing updates to the SEC, which could include important financial or operational information for investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report without immediate disclosed negative or positive material events.

Key Players & Entities

• ProMIS Neurosciences Inc. (company) — Registrant
• July 26, 2024 (date) — Date of earliest event reported
• 1920 Yonge Street (address) — Principal executive offices
• Toronto, Ontario (location) — Principal executive offices

FAQ

Filing Documents

• pmn-20240726x8k.htm (8-K) — 41KB
• pmn-20240726xex99d1.htm (EX-99.1) — 20KB
• pmn-20240726xex99d1001.jpg (GRAPHIC) — 4KB
• 0001558370-24-010223.txt ( ) — 206KB
• pmn-20240726.xsd (EX-101.SCH) — 4KB
• pmn-20240726_def.xml (EX-101.DEF) — 3KB
• pmn-20240726_lab.xml (EX-101.LAB) — 17KB
• pmn-20240726_pre.xml (EX-101.PRE) — 12KB
• pmn-20240726x8k_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On July 26, 2024, ProMIS Neurosciences Inc. (the "Company") issued a press release announcing positive data from the first four cohorts in its first-in-human Phase 1a clinical trial of PMN310 in healthy volunteers ("Press Release"). 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 July 26, 2024, the Company issued the Press Release announcing positive data from the first four cohorts in its first-in-human Phase 1a clinical trial of PMN310 in healthy volunteers. PMN310 was generally well-tolerated through the first four single-ascending (SAD) dose cohorts (2.5, 5, 10, 20 mg/kg), with no treatment-emergent serious adverse events (SAEs) observed after administration of PMN310. Cerebrospinal fluid (CSF) collection was done on days 3 and 29 after PMN310 administration. Measurement of PMN310 levels in CSF showed dose proportionality at both days 3 and 29, with the lowest dose reaching a greater than 100-fold molar excess compared to expected levels of oligomers in the CSF. The half-life of PMN310 in CSF was approximately 25 days, which is supportive of once per month dosing. The Phase 1a clinical trial was a randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of PMN310 in healthy volunteers (NCT06105528). The study consisted of five SAD cohorts and was designed to evaluate the safety, tolerability, and pharmacokinetics (PK), of intravenous doses of PMN310. The study completed enrollment of all 40 subjects across 2 active sites in the United States. The Company has completed its analysis of the first four cohorts with the fifth and final cohort undergoing final analysis; we anticipate the fifth cohort will yield similar encouraging results. The trial was initiated based on encouraging nonclinical studies of PMN310 that support the selective targeting of AOs. The Company expects to present the full dataset at an upcoming medical meeting in the second half of 2024. The Company plans to advance PMN310 into the Phase 1b portion of the clinical study in the coming months.

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 top-line results from the first four cohorts of its Phase 1a study and the potential implications thereof, the analysis and expected results of the fifth cohort; the Company's expectations regarding its clinical development of its lead product, PMN310, for AD, and the Company's anticipated top-line data readout for all five cohorts of its Phase 1a study in the coming months and plans to advance into a Phase 1b multiple ascending dose study in AD patients in the coming months. 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

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated July 26, 2024 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: July 26, 2024 By: /s/ Neil Warma Name: Neil Warma Title: Interim Chief Executive Officer