UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer Pursuant to Rule 13a-16or 15d-16
Under the Securities Exchange Act of 1934
For the Month of June 2025
Commission File Number: 001-41084
NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9-7996183
(Address of principal executive office)
Indicate by check mark whether the registrant filesor will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
NeuroSense Therapeutics Ltd. (the “Company”)reports that, following its prior public communications on the matter, the Company has completed its pre-New Drug Submission (pre-NDS)meeting with Health Canada regarding the potential early approval of PrimeC for the treatment of ALS, under the expedited Notice of Compliancewith Conditions (NOC/c) pathway.
The Company and Health Canada are currently finalizingthe official meeting minutes, after which the Company will receive formal notification regarding its eligibility to proceed with an NDSunder the NOC/c pathway. The Company was highly encouraged by the constructive dialogue and positive tone of the meeting and looks forwardto providing a comprehensive update following receipt of the official notification.
This Reporton Form 6-K is hereby incorporated by reference into registrant’s Registration Statements on FormS-8 (File No. 333-262480) and Form F-3 (File No. 333-269306, 333-260338, 333-283656 and 333-284051),to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequentlyfiled or furnished.
Forward-LookingStatements
This Form6-K release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements,other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements containedin this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,”“could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,”“plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,”“will” “would,” or the negative of these words or other similar expressions, although not all forward-lookingstatements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subjectto inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding a meeting with HealthCanada. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Thefuture events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in theforward looking statements. These risks include the risk that the Health Canada will not approve PrimeC under the NOC/c pathway, or atall, or such approval will be delayed, that partnership discussions regarding PrimeC will not lead to execution of a definitive agreement,or that, if executed, will not lead to the current anticipated benefits to NeuroSense, a delay in the planned Phase 3 study for PrimeCin ALS or that its scope will be different than anticipated, lower than anticipated market opportunity in Canada and elsewhere, the riskthat NeuroSense will need capital earlier than currently anticipated, that regulatory approvals for PrimeC will be delayed or not obtainedin Canada or elsewhere; unexpected R&D costs or operating expenses, insufficient capital to complete development of PrimeC, a delayin the reporting of additional results from PARADIGM clinical trial, the timing of expected regulatory and business milestones, risksassociated with meeting with the FDA and Health Canada to determine the best path forward following the results from PARADIGM clinicaltrial, including a delay in any such meeting; the potential for PrimeC to safely and effectively target ALS; preclinical and clinicaldata for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; thedevelopment and commercial potential of any product candidates of Neurosense; the ability of NeuroSense to remain listed on Nasdaq; andother risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should notrely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSenseis contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commissionon April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement aremade as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
1
SIGNATURES
Pursuant to the requirementsof the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereuntoduly authorized.
| NeuroSense Therapeutics Ltd. | ||
| Date: June 26, 2025 | By: | /s/ Alon Ben-Noon |
| Alon Ben-Noon | ||
| Chief Executive Officer | ||
2