# EDGAR Filing Document

**Accession Number:** 0001875091
**File Stem:** 0001213900-23-010512
**Filing Date:** 2023-2
**Character Count:** 9150
**Document Hash:** 5eef38d477e79871442e0b5a797b416c
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-23-010512.hdr.sgml**: 20230213

**ACCESSION NUMBER**: 0001213900-23-010512

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 4

**CONFORMED PERIOD OF REPORT**: 20230213

**FILED AS OF DATE**: 20230213

**DATE AS OF CHANGE**: 20230213

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** NeuroSense Therapeutics Ltd.
- **CENTRAL INDEX KEY:** 0001875091
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** L3
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41084
- **FILM NUMBER:** 23615131

**BUSINESS ADDRESS:**
- **STREET 1:** 11 HAMENOFIM ST.
- **STREET 2:** BUILDING B
- **CITY:** HERZLIYA
- **STATE:** L3
- **ZIP:** 4672562
- **BUSINESS PHONE:** 972-9-9531142

**MAIL ADDRESS:**
- **STREET 1:** 11 HAMENOFIM ST.
- **STREET 2:** BUILDING B
- **CITY:** HERZLIYA
- **STATE:** L3
- **ZIP:** 4672562

**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 February 2023

Commission File Number: 001-41084

**NeuroSense Therapeutics Ltd.**

(Translation of registrant's name into English)

**11 HaMenofim Street, Building B<br> Herzliya 4672562 Israel<br> +972-9-799-6183**<br> (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 February 13, 2023, NeuroSense Therapeutics Ltd. (the "Company") issued a press release which includes a corporate update video from the Company's founder and CEO Alon Ben-Noon. A copy of the press release is filed herewith as Exhibit 99.1.

**Exhibit Index**

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press Release, dated February 13, 2023](ea173305ex99-1_neurosense.htm) |

---

**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.** | **NeuroSense Therapeutics Ltd.** |
| Date: February 13, 2023 | By: | /s/ Alon Ben-Noon |
|  |  | Alon Ben-Noon |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**NeuroSense CEO Recaps 2022 Achievements & Presents 2023 Catalysts**

 ****

***View video here: LINK***

CAMBRIDGE, Mass., Feb. 13, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today released a corporate update video from its Founder and CEO Alon Ben-Noon.

![](ex99-1_001.jpg)

The company believes that 2023 presents many opportunities for growth at NeuroSense as topline results are expected in the second half of the year from its Phase 2b PARADIGM clinical trial in amyotrophic lateral sclerosis (ALS). The PARADIGM protocol is now approved for enrollment in four countries: Israel, Italy, Canada, and Germany. Based on recently announced positive AD biomarker study results, NeuroSense plans to commence a Phase 2 study in Alzheimer's disease in the first half of 2023. In the coming weeks, NeuroSense expects to announce biomarker study results in Parkinson's disease as well.

"Reflecting on this past year, NeuroSense's strong performance in 2022 gives great cause for optimism," stated Alon Ben-Noon. "I thank our dedicated team, collaborators, shareholders, and the ALS community."

Video highlights include the following:

**ALS Clinical Program for Lead Drug Candidate PrimeC**

● PARADIGM: Phase 2b double-blind, placebo-controlled, multinational clinical trial aims to assess PrimeC's efficacy, as well as safety & tolerability, in people living with ALS.

● Over 50% of the 69 patients have been enrolled, and additional clinical sites are expected to open in the coming weeks.

● Enrollment is expected to be completed in H1 2023.

● Topline results are expected in H2 2023.

● Both a single-dose and a multi-dose Phase 1 open-label, randomized, three-treatment, three-period crossover pharmacokinetic (PK) study were carried out in the US under an FDA-cleared IND protocol.

● Results suggest that the PK profile of PrimeC supports the formulation's extended release properties, as the active components are released simultaneously.

**Pipeline**

● Novel biomarkers found in Alzheimer's disease patients were identified in the Company's studies carried out in 2022, with final results announced in January 2023. These biomarkers could potentially be modulated by the Company's combination therapy platform.

● The Company intends to conduct a Phase 2 double-blind proof-of-concept study to assess the therapeutic potential of its platform combination drug therapy in AD. This study is expected to commence in the first half of 2023, under the current 2023 budget.

● A Parkinson's disease biomarker study is ongoing with results expected in the next few weeks.

The company invites anyone who is interested to watch the video for more on NeuroSense's progress to date and an overview of upcoming catalysts and milestones: LINK

**About NeuroSense**

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-Looking Statements**

 

*This press 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 contained 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-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding patent applications; the company's PrimeC development program; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of the report of topline results of PARADIGM; the timing of commencement of our Phase 2 study in Alzheimer's; the timing of current and future clinical trials; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Forward looking statements are subject to a number of risks and uncertainties, including a delay in the reporting of top-line results from our ALS Phase 2b clinical trial, a delay in commencement of our Phase 2 study in Alzheimer's and a delay in other clinical and regulatory milestones. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 14, 2022. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense Therapeutics Ltd. undertakes no duty to update such information except as required under applicable law.*

Video: https://youtu.be/sWEmVSDPbDg<br> Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

![](ex99-1_002.jpg)