NeuroSense Therapeutics Ltd 6-K, filed Jun 27, 2022

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 June 2022

Commission File Number: 001-41084

NeuroSense Therapeutics Ltd.

(Translation of registrant’s name into English)

11 HaMenofim Street, Building BHerzliya 4672562 Israel+972-9-799-6183(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 ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

On June 27, 2022, NeuroSense Therapeutics Ltd. issued a press release announcing results from Stage III of its biomarker study conducted in collaboration with Massachusetts General Hospital to evaluate PrimeC. A copy of the press release is filed herewith as Exhibit 99.1.

Exhibit Index

1

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.

2

Exhibit99.1

NeuroSenseReports Positive Results from Stage III ALS Biomarker Study

<br><br> <br><br><br> <br>Dr. Shiran Zimri, Head of Scientific Programs at NeuroSense Therapeutics

CAMBRIDGE,<br>Mass., June 27, 2022 -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a company developing treatments<br>for severe neurodegenerative diseases, today announced results from Stage III of its biomarker study conducted in collaboration with<br>Massachusetts General Hospital (MGH) to evaluate PrimeC, NeuroSense’s lead combination drug candidate for the treatment of amyotrophic<br>lateral sclerosis (ALS). PrimeC is currently being evaluated in NeuroSense’s Phase IIb PARADIGM study following the successful<br>conclusion of its Phase IIa study which met its primary endpoints.<br><br> <br><br><br> <br>The<br>purpose of the initial ALS biomarker study (Stage I) was to characterize the baseline phenomena observed in people living with ALS. The<br>study identified novel ALS biomarkers that are indicative of PrimeC’s mechanism of action (MOA), via an analysis comparing blood<br>samples obtained from healthy people and from people living with ALS. TDP-43 accumulation and neuroinflammation via prostagladin2 were<br>amongst the disease-modifying targets characterized, along with miRNA dysregulation, iron accumulation, lysosomal dysfunction, and impaired<br>autophagy.<br><br> <br><br><br> <br>Stage<br>II investigated the therapeutic effect of PrimeC. In NeuroSense’s Phase IIa study blood samples were analyzed to determine the<br>longitudinal effect of PrimeC on the biomarkers identified in Stage I. Following 12 months of administration with PrimeC, statistically<br>significant changes in key ALS-related biomarkers were observed in study participants. Furthermore, the study established a correlation<br>between the clinically meaningful outcomes detected and modulations in those biomarkers.

The Stage III natural history study analyzed blood samples from people living with ALS, treated with standard of care. Preliminary results show that levels of disease-related biomarkers remain steady and unchanged in people living with ALS, in contrast to the statistically significant decline portrayed in these biomarkers when PrimeC was administered in addition to the standard of care. Stage III results further confirmed PrimeC’s MOA, and expanded insight into ALS-related biomarkers and their correlation to the progression of ALS symptoms.

“These results are encouraging, especially in that they validate NeuroSense’s clinical strategy. The biomarker study, along with the data we collect from our Phase IIb study, will inform the optimization of a pivotal Phase III study of PrimeC in ALS,” stated NeuroSense’s CEO, Alon Ben-Noon. “NeuroSense is honored to collaborate with the world-class MGH team on this critical study.”

“NeuroSense remains at the forefront of biomarker research with the inclusion of a comprehensive portfolio of biomarkers in our Phase IIb study. This is essential in exploring mechanistic associations in ALS,” stated Shiran Zimri, Head of Scientific Programs at NeuroSense. “The use of neuronal derived exosomes (NDE), a cutting-edge technology, allows one to observe key alterations in biomarkers found in the central nervous system. We look forward to sharing more detailed results at the upcoming World Orphan Drug Congress in Boston, Massachusetts on July 11-13^th^.”

AboutPrimeC

PrimeC, NeuroSense’s lead drug candidate is a combination therapy that was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NeuroSense completed a Phase IIa clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC’s biological activity. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs), NeuroSense is working to further analyze the results and correlations to the clinical data, to determine the biological changes in ALS-related pathologies and the magnitude of the effect of PrimeC on relevant targets..

AboutALS

Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.

AboutNeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn and Twitter.

Forward-LookingStatements

Thispress 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 statementscontained in 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 the company’s PrimeCdevelopment program; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timingof current and future clinical trials; the nature, strategy and focus of the company and further updates with respect thereto; and thedevelopment and commercial potential of any product candidates of the company. Further, certain forward-looking statements are basedon assumptions as to future events that may not prove to be accurate. Forward-looking statements contained in this announcement are madeas of this date, and NeuroSense Therapeutics Ltd. undertakes no duty to update such information except as required under applicable law.

For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183