NeuroSense Therapeutics Ltd 6-K, filed Jul 6, 2023
NeuroSense Therapeutics Ltd. (NRSN)
About this 6-K
NeuroSense Therapeutics Ltd filed this 6-K on July 6, 2023.
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 JULY 2023
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
(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 ☐
On July 6, 2023, NeuroSense Therapeutics Ltd. (the “Company”) issued a press release announcing a Q2 Update from the Company’s CEO, Alon Ben-Noon. A copy of the press release is filed herewith as Exhibit 99.1.
This Report on Form 6-K (other than the paragraph immediately preceding the heading “About NeuroSense” in Exhibit 99.1) is hereby incorporated by reference into the registrant’s Registration Statements on Form F-3 (File No. 333-269306) and Form S-8 (File No. 333-262480), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
1
SIGNATURE
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. | |||
| By: | /s/ Alon Ben-Noon | ||
| Name: | Alon Ben-Noon | ||
|
Title: |
Chief Executive Officer | ||
Date: July 6, 2023
2
Exhibit 99.1
NeuroSense CEO Provides Q2 2023 Update
View video here: Link
CAMBRIDGE, Mass., July 6, 2023 -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, today provided an update from its CEO, Alon Ben-Noon, on the Company’s clinical and operational developments during the second quarter of 2023.
Phase 2b Amyotrophic Lateral Sclerosis (ALS) PARADIGM Trial Completed Patient Enrollment
| ● | Topline results expected Q4 2023 | |
| ● | 96% of participants who completed the trial chose to continue in the study and be treated with PrimeC through a 12-month open-label extension |
Strategic Scientific Agreement with Biogen
| ● | Biogen will evaluate the impact of PrimeC on neurofilament levels in the plasma of participants in NeuroSense’s Phase 2b ALS PARADIGM trial | |
| ● | Biogen will fund this meaningful neurofilament biomarker study and upon receipt of results, has the right of first refusal to co-develop / commercialize PrimeC for the treatment of ALS for a limited time following the results |
Phase 2 Alzheimer’s Disease (AD) Trial Under Preparation
| ● | Biomarker study revealed elevated levels of novel biomarker TDP-43 in AD as compared to healthy controls | |
| ● | Results demonstrate therapeutic potential of NeuroSense’s combination drug platform for AD | |
| ● | Phase 2 double-blind proof-of-concept clinical study is now under preparation, with regulatory submissions and site readiness ongoing during Q2 2023 and first patient enrolled expected in Q3 2023 |
Parkinson’s Disease (PD) Biomarker Study Completed
| ● | NeuroSense observed a statistically significant (p= 0.002) decrease in levels of AGO2, a novel PD biomarker, in newly diagnosed PD patients (n=15) when compared to the healthy control group | |
| ● | Planning to co-develop PD indication with collaborators that have a core focus on Parkinson’s |
Capital Raise of $4.5 Million
| ● | NeuroSense is funded now through mid-2024 with major inflection points expected, including top-line results from PARADIGM |
“With enrollment of PARADIGM completed, we are on track to report topline results before the end of 2023 as we work on several additional value-driving events.” stated Alon Ben-Noon, CEO of NeuroSense.
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 the timing of preclinical and clinical data for PrimeC and the timing of enrollment for clinical trials. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements due to a number of risks and uncertainties. Such risks and uncertainties include 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. 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 March 22, 2023. You should not rely on these statements as representing our views in the future. 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.
For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183