NeuroSense Therapeutics (NRSN) details long-term ALS PrimeC use and safety

Rhea-AI Filing Summary

NeuroSense Therapeutics Ltd. reports long-term follow-up data from its Phase 2a study in people with ALS treated with its drug candidate PrimeC. As of August 20, 2025, approximately 20% of people with ALS from this study, including those continuing treatment under compassionate use, remain on PrimeC for more than 5.5 years and have lived with ALS for over 7 years. Across these multi-year treatment exposures, PrimeC is described as well tolerated, with no new safety signals observed to date. The company also notes that this report is incorporated by reference into several of its existing registration statements.

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 August 2025

Commission File Number: 001-41084

NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)

NeuroSense Therapeutics Ltd.

11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9- 7996183
(Address of principal executive offices)

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 ☐

As of August 20, 2025, approximately 20% of people with ALS from the Company’s Phase 2a study -  including those continuing under compassionate use - remain on PrimeC for more than 5.5 years, having lived with ALS for over 7 years. Across these multi-year exposures, treatment remains well tolerated, with no new safety signals observed to date.

This Report on Form 6-K (other than the third paragraph of Exhibit 99.1) is hereby incorporated by reference into 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333-283656 and 333-284051), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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: August 20, 2025	By:	/s/ Alon Ben-Noon
		Alon Ben-Noon
		Chief Executive Officer

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FAQ

What key update does NeuroSense Therapeutics (NRSN) provide in this Form 6-K?

NeuroSense Therapeutics provides an update on long-term follow-up from its Phase 2a ALS study of PrimeC, noting that a portion of participants remain on treatment for more than 5.5 years with no new safety signals observed.

How many ALS patients from NeuroSense Therapeutics' Phase 2a study remain on PrimeC?

The company reports that as of August 20, 2025, approximately 20% of people with ALS from its Phase 2a study, including those under compassionate use, remain on PrimeC.

What does NeuroSense say about the long-term safety of PrimeC in ALS patients?

NeuroSense states that across multi-year exposures of more than 5.5 years on PrimeC, treatment remains well tolerated and no new safety signals have been observed to date.

How long have the long-term ALS patients on PrimeC been living with the disease?

The company notes that these long-term patients have lived with ALS for over 7 years while remaining on PrimeC for more than 5.5 years.

How is this NeuroSense Therapeutics Form 6-K used in relation to its registration statements?

The report states that, other than the third paragraph of Exhibit 99.1, it is incorporated by reference into NeuroSense’s registration statements on Form S-8 and Form F-3, becoming part of those documents from the submission date.

Does this NeuroSense 6-K include financial or earnings data?

This report focuses on clinical and regulatory information, specifically long-term PrimeC use in ALS, and its incorporation into existing registration statements, without presenting earnings or financial performance data.