0001558370-24-006202.txt : 20240430 0001558370-24-006202.hdr.sgml : 20240430 20240430075602 ACCESSION NUMBER: 0001558370-24-006202 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 17 CONFORMED PERIOD OF REPORT: 20240430 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240430 DATE AS OF CHANGE: 20240430 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ProMIS Neurosciences Inc. CENTRAL INDEX KEY: 0001374339 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: Z4 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-41429 FILM NUMBER: 24894078 BUSINESS ADDRESS: STREET 1: SUITE 200, 1920 YONGE STREET CITY: TORONTO STATE: A6 ZIP: M4S 3E2 BUSINESS PHONE: 416-847-6898 MAIL ADDRESS: STREET 1: SUITE 200, 1920 YONGE STREET CITY: TORONTO STATE: A6 ZIP: M4S 3E2 FORMER COMPANY: FORMER CONFORMED NAME: AMORFIX LIFE SCIENCES LTD DATE OF NAME CHANGE: 20060831 8-K 1 pmn-20240430x8k.htm 8-K
0001374339false00013743392024-04-302024-04-30

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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): April 30, 2024

PROMIS NEUROSCIENCES INC.

(Exact name of registrant as specified in its charter)

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​

​

​

​

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​

Canada

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001-41429

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98-0647155

(State or other jurisdiction
of incorporation)

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(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:

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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 April 30, 2024, ProMIS Neurosciences Inc. (the “Company”) issued a press release announcing the publication of a paper titled, “Relationship between therapeutic activity and preferential targeting of toxic soluble aggregates by amyloid-beta-directed antibodies,” in the online journal, bioRxiv (the “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.

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Item 8.01 Other Events.

On April 30, 2024, the Company issued the Press Release referenced above. The study characterized and compared the binding profile of various amyloid-beta (Aß)-directed antibodies to monomers, soluble oligomers and insoluble Aß fibrils. The results indicate that selectivity for soluble toxic Aß oligomers may be a driver of clinical efficacy and indicated that PMN310 displayed the greatest degree of oligomer selectivity. PMN310, the Company’s novel monoclonal antibody being evaluated as a treatment for Alzheimer’s disease (“AD”), is currently undergoing Phase 1a clinical studies in healthy volunteers, with initial safety and pharmacokinetic data expected in mid-2024.

Aß-directed antibodies tested clinically for therapeutic activity against AD have shown varying degrees of efficacy. A side-by-side comparison of antibody binding to different molecular species of Aß conducted by ProMIS provided insight into the observed variability in clinical outcomes. A correlation was observed between reported clinical efficacy and the ability of an antibody to retain binding to soluble oligomers from AD brains when faced with monomer competition. PMN310 showed a high degree of resistance to monomer competition. Importantly, unlike all other antibodies tested, PMN310 also avoided binding to plaque and vascular deposits of Ab. Consequently, PMN310, may reduce the risk of brain edema (ARIA-E) and microhemorrhages (ARIA-H) often associated with plaque-binding antibodies. This premise is supported by the results showing that weekly dosing of a murine version of PMN310 at very high doses (800 mg/kg) for 26 weeks in a mouse model of AD did not cause any detectable brain hemorrhages upon microscopic examination.

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 study and reported therapeutic activity and preferential targeting of toxic soluble aggregates by Aß-directed antibodies and the potential implications thereof, 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 our Phase 1a study in the first half of 2024 and plans to advance into a Phase 1b multiple ascending dose study in AD patients. 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 from those expressed or implied by such forward-looking information, including, but not limited to, the risk that the results of nonclinical studies and early clinical trials are not necessarily predictive of future results with PMN310, the Company’s ability to fund its operations and continue as a going concern, its accumulated deficit and the expectation for continued losses and future financial results. Important factors that could cause actual results to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the “Risk Factors” section of the Company's most recently filed Annual Report on Form 10-K for the year ended December 31, 2023 and in its subsequent filings filed with the United States Securities and Exchange Commission. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

    

Description

99.1

​

Press Release, dated April 30, 2024

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: April 30, 2024

By:

/s/ Neil Warma

Name: Neil Warma

Title: Chief Executive Officer

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​

​

 EX-99.1 2 pmn-20240430xex99d1.htm EX-99.1

Exhibit 99.1

Graphic

ProMIS Neurosciences Publishes Study Highlighting Oligomer Selectivity and Benefit of Amyloid-Beta-Directed Antibodies

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Study results support differentiation of PMN310 from other amyloid-beta-directed antibodies

​

CAMBRIDGE, Massachusetts and TORONTO, Ontario – April 30, 2024 – ProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced the publication of a paper titled, “Relationship between therapeutic activity and preferential targeting of toxic soluble aggregates by amyloid-beta-directed antibodies," in the online journal, bioRxiv.

​

The study characterized and compared the binding profile of various amyloid-beta (Ab)-directed antibodies to monomers, soluble oligomers and insoluble Ab fibrils. The results indicate that selectivity for soluble toxic Aß oligomers may be a driver of clinical efficacy and indicated that PMN310 displayed the greatest degree of oligomer selectivity. PMN310, the Company’s novel monoclonal antibody being evaluated as a treatment for Alzheimer’s disease (AD), is currently undergoing Phase 1a clinical studies in healthy volunteers, with initial safety and pharmacokinetic data expected in mid-2024.

​

“The data in this publication highlight PMN310’s high degree of selectivity for toxic Ab oligomers and its differentiation from other Ab-directed antibodies,” stated Neil Warma, Chief Executive Officer of ProMIS Neurosciences. “We believe that PMN310’s ability to avoid both monomer and plaque binding has the potential to improve efficacy and reduce the risk of amyloid-related imaging abnormalities (ARIA), a key indicator of edema and microhemorrhage risk associated with plaque binding antibody therapies currently on the market and in development. We look forward to the top-line data readout for our Phase 1a study in the coming months and to advancing PMN310 into a Phase 1b multiple ascending dose study in AD patients.”

​

Aß-directed antibodies tested clinically for therapeutic activity against AD have shown varying degrees of efficacy. A side-by-side comparison of antibody binding to different molecular species of Aß conducted by ProMIS provided insight into the observed variability in clinical outcomes. A correlation was observed between reported clinical efficacy and the ability of an antibody to retain binding to soluble oligomers from AD brains when faced with monomer competition. PMN310 showed a high degree of resistance to monomer competition. Importantly, unlike all other antibodies tested, PMN310 also avoided binding to plaque and vascular deposits of Ab. Consequently, PMN310, may reduce the risk of brain edema (ARIA-E) and microhemorrhages (ARIA-H) often associated with plaque-binding antibodies. This premise is supported by the results showing that weekly dosing of a murine version of PMN310 at very high doses (800 mg/kg) for 26 weeks in a mouse model of AD did not cause any detectable brain hemorrhages upon microscopic examination.

​

The complete article can be accessed online here.

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About ProMIS Neurosciences Inc.

​

ProMIS Neurosciences Inc. is a clinical stage biotechnology company focused on generating and developing antibody therapeutics selectively targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA). The Company’s proprietary target discovery engine applies a thermodynamic, computational discovery platform - ProMIS™ and Collective Coordinates - to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and MSA. ProMIS has offices in Cambridge, Massachusetts and Toronto, Ontario.

​

Forward-Looking Statements

​

This press release 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 news release 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 news release contains forward-looking information relating to the study and reported therapeutic activity and preferential targeting of toxic soluble aggregates by Aß-directed antibodies and the potential implications thereof, 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 our Phase 1a study in the first half of 2024 and plans to advance into a Phase 1b multiple ascending dose study in AD patients. 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 news release, 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 from those expressed or implied by such forward-looking information, including, but not limited to, the risk that the results of nonclinical studies and early clinical trials are not necessarily predictive of future results with PMN310, the Company’s ability to fund its operations and continue as a going concern, its accumulated deficit and the expectation for continued losses and future financial results. Important factors that could cause actual results to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the “Risk Factors” section of the Company's most recently filed Annual Report on Form 10-K for the year ended December 31, 2023 and in its subsequent filings filed with the United States Securities and Exchange Commission. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

​

For further information:

​

Visit us at www.promisneurosciences.com

​

​

Please submit media inquiries to info@promisneurosciences.com.

​

For Investor Relations, please contact:

Stern Investor Relations

Anne Marie Fields, Managing Director

annemarie.fields@sternir.com

Tel. 212-362-1200

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Document and Entity Information
Apr. 30, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Apr. 30, 2024
Entity Registrant Name PROMIS NEUROSCIENCES INC.
Entity Incorporation, State or Country Code Z4
Entity File Number 001-41429
Entity Tax Identification Number 98-0647155
Entity Address, Address Line One Suite 200
Entity Address, Adress Line Two 1920 Yonge Street
Entity Address, City or Town Toronto
Entity Address State Or Province ON
Entity Address, Postal Zip Code M4S 3E2
City Area Code 416
Local Phone Number 847-6898
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Shares, no par value per share
Trading Symbol PMN
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
Entity Central Index Key 0001374339
Amendment Flag false
XML 10 R2.htm IDEA: XBRL DOCUMENT v3.24.1.u1
Document Information
Apr. 30, 2024
Document Information:  
Document Type 8-K
Amendment false
CIK 0001374339
Registrant Name PROMIS NEUROSCIENCES INC.
Period End Date Apr. 30, 2024
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