[6-K] NeuroSense Therapeutics Ltd. Current Report (Foreign Issuer)

Rhea-AI Filing Summary

NeuroSense Therapeutics Ltd. reports limited clinical survival outcomes and filing cross-references. In the sample presented, 50% (15 of 30) of participants originally randomized to the investigational treatment PrimeC remain alive, while approximately 7% (1 of 14) of participants originally randomized to placebo remain alive. The report also incorporates references to Form S-8 (File No. 333-262480) and multiple Form F-3 filings (File Nos. 333-269306, 333-260338, 333-283656 and 333-284051) to be part of the report from the submission date, subject to any later superseding documents. The filing is signed by CEO Alon Ben-Noon.

Positive

• PrimeC observed survivors: 50% (15 of 30) of participants originally randomized to PrimeC remain alive
• Corporate compliance: The report references Forms S-8 and multiple F-3 filings, indicating active securities filings coverage

Negative

• Placebo survival low: Approximately 7% (1 of 14) of participants originally randomized to placebo remain alive
• Insufficient context: No information on follow-up duration, trial endpoints, statistical analysis, or safety data is provided in the excerpt

Insights

Clinical Development Analyst

TL;DR: Reported survival numbers favor PrimeC in this small sample, and the company attaches registration/exemption filings.

The disclosed data show 15/30 survivors on PrimeC versus 1/14 on placebo, which indicates a raw difference in observed survival rates within the described cohorts. The filing also references securities registration/exemption documents (Form S-8 and multiple Form F-3 filings), suggesting routine corporate reporting and potential equity-related administrative actions. The dataset size and context are not provided in this excerpt, limiting interpretation of statistical significance, safety, duration of follow-up, or broader trial outcomes.

Corporate Securities Analyst

TL;DR: The document combines a brief clinical outcome snapshot with standard securities filing cross-references; materiality is unclear from the excerpt.

Reference to Form S-8 and several Form F-3 filings typically relates to securities registration and disclosure obligations. The report is signed by the CEO, indicating authorized corporate disclosure. Without additional detail on the trial design, timelines, patient populations, or related financial impact, assessing investor materiality is not possible from this text alone.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

For the Month of September 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 files or 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 Additional Clinical Data from its Phase 2b PARADIGM Study

More than three years from initiation of the Phase 2b PARADIGM Study, survival analyses from the largest study site of the study located in Israel, which enrolled 44 patients (approximately two-thirds of all participants in the study) and began enrollment nearly one year earlier than the other study sites, resulting in the longest follow-up and the most mature survival dataset of the study to date, demonstrated a substantial difference in survival rates between the treatment arms:

● 50% (15/30) of participants originally randomized to PrimeC remain alive;

● Approximately 7% (1/14) of participants originally randomized to placebo remain alive.

This outcome represents a more than seven-fold survival advantage for patients treated with PrimeC, a difference that achieved statistical significance (p=0.007, Fisher’s exact test).

These results highlight the potential of PrimeC to meaningfully extend survival in ALS, a disease with urgent unmet need and limited therapeutic options.

Among the surviving participants, 12 of those originally randomized to PrimeC remain ventilation-free, compared with only 1 participant originally randomized to placebo.

The Company continues to generate and analyze long-term clinical data to provide supportive evidence for regulatory submissions, including with Health Canada, as part of its global development and commercialization strategy.

This Report on Form 6-K other than Exhibit 99.1 is hereby incorporated by reference into the registrant’s Registration Statements on Form S-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 subsequently filed or furnished.

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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, thereunto duly authorized.

	NeuroSense Therapeutics Ltd.
Date: September 4, 2025	By:	/s/ Alon Ben-Noon
		Alon Ben-Noon
		Chief Executive Officer

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FAQ

What survival results does NeuroSense (NRSN) report in this filing?

The filing states 50% (15/30) of participants originally randomized to PrimeC remain alive and approximately 7% (1/14) of those randomized to placebo remain alive.

Does the filing include financial statements or earnings data for NRSN?

No. The excerpt contains clinical outcome counts and references to Form S-8 and Form F-3 filings; it does not include earnings or financial statement data.

What securities filings are referenced in the NeuroSense report?

The report references Form S-8 (File No. 333-262480) and multiple Form F-3 filings (File Nos. 333-269306, 333-260338, 333-283656, 333-284051) as becoming part of the report from the submission date.

Who signed the NeuroSense current report (6-K)?

The filing is signed by Alon Ben-Noon, Chief Executive Officer.

Is there enough information to evaluate the clinical significance of the reported survival numbers?

No. The excerpt lacks key details such as follow-up time, trial design, baseline characteristics, statistical analysis, and safety outcomes, which are necessary to evaluate significance.