0001104659-23-119726.txt : 20231120 0001104659-23-119726.hdr.sgml : 20231120 20231120070519 ACCESSION NUMBER: 0001104659-23-119726 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20231120 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231120 DATE AS OF CHANGE: 20231120 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ProMIS Neurosciences Inc. CENTRAL INDEX KEY: 0001374339 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] 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: 231420696 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 tm2331130d1_8k.htm FORM 8-K
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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): November 20, 2023

  

PROMIS NEUROSCIENCES INC.

(Exact name of registrant as specified in its charter)

 

 

 

Ontario, 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 x

 

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 November 20, 2023, Promis Neurosciences, Inc. (the "Company") issued a press release announcing that the Company dosed the first subject in a first-in-human Phase 1a clinical trial of PMN310 as a potential treatment for Alzheimer’s disease (“AD”). PMN310 is the Company’s novel monoclonal antibody that is designed to be highly selective for toxic oligomers of amyloid-beta, which are believed to be a major driver of 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.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press Release dated November 20, 2023
104   Cover Page Interactive Data File (embedded within 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.

 

  PROMIS NEUROSCIENCES INC.
     
Date: November 20, 2023 By: /s/ Gail Farfel
    Name: Gail Farfel
    Title: Chief Executive Officer

 

 

 EX-99.1 2 tm2331130d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

ProMIS Neurosciences Doses First Subjects in Phase 1a Clinical Trial of PMN310 to Treat Alzheimer’s Disease

 

Advances novel monoclonal antibody designed to be highly selective for toxic oligomers of amyloid-beta (Aβ) in first-in-human study

 

TORONTO, Ontario and CAMBRIDGE, Massachusetts – November 20, 2023 – 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 that the Company dosed the first subjects in a first-in-human Phase 1a clinical trial of PMN310 as a potential treatment for Alzheimer’s disease (AD).  PMN310 is the Company’s novel monoclonal antibody that is designed to be highly selective for toxic oligomers of amyloid-beta (Aβ), which are believed to be a major driver of AD.

 

“Initiation of this milestone study of PMN310 marks our transition to a clinical stage company. We are excited to bring our precision medicine approach into the clinic in hopes of developing better therapeutics for neurodegenerative diseases,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. “During the third quarter, we raised more than $20 million through a private placement financing, which meaningfully strengthens our balance sheet and supports ProMIS through potentially value-creating milestones.”

 

“In this Phase 1a clinical trial, we will enroll up to five cohorts of eight adult healthy volunteers, each receiving a single dose of PMN310. We expect to have initial safety and pharmacokinetic (PK) data to share in the first half of 2024. We remain committed to investigating our hypothesis that selective targeting of toxic Aβ oligomers while avoiding monomer distraction and plaque binding will potentially provide differentiation on both safety and efficacy in AD treatment response.

 

“Results from the Phase 1a study will facilitate dose selection for subsequent Phase 1b study in patients with Mild Cognitive Impairment (MCI) due to AD and patients with mild AD. This study will leverage recent results from a third-party clinical study, which demonstrated that plasma and cerebrospinal fluid (CSF) efficacy biomarkers can show a treatment response in as little as three months with oligomer-focused therapy. In addition, our Phase 1b study will provide important insights into the safety profile of PMN310, which we anticipate may differentiate PMN310 from other available and potentially disease-modifying treatments.”

 

About the Phase 1a Clinical Trial

 

The study titled, “A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PMN310 Infusions in Healthy Volunteers,” is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK of single ascending doses of intravenous PMN310 in healthy adult volunteers. Eligible subjects will participate in the 85-day study with one optional follow up assessment at Day 120. Primary PK data will be obtained from day 1 to day 29. 

 

 

 

 

More information about the Phase 1 clinical trial can be found at www.clinicaltrials.gov or click here.

 

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 Toronto, Ontario and Cambridge, Massachusetts.

 

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 Company's planned timing for completion and anticipated data readout of the Phase 1a clinical trial and the anticipated use of proceeds from the private placement. 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 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 information form available on www.SEDAR.com, in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2022 and the section entitled “Risk Factors” in its Post-Effective Amendment No. 1 to Form S-1, filed March 17, 2023, each as filed with the Securities and Exchange Commission, and subsequent quarterly reports. 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 Field, Managing Director

annemarie.fields@sternir.com

Tel. 212-362-1200

 

 

 

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Cover
Nov. 20, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 20, 2023
Entity File Number 001-41429
Entity Registrant Name PROMIS NEUROSCIENCES INC.
Entity Central Index Key 0001374339
Entity Tax Identification Number 98-0647155
Entity Incorporation, State or Country Code A6
Entity Address, Address Line One Suite 200
Entity Address, Address 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
Elected Not To Use the Extended Transition Period false
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