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 OCTOBER 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
+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 ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On October 17, 2023, NeuroSense
Therapeutics Ltd. (the “Company”) issued a press release announcing a Q3 2023 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 (with respect to exhibit 99.1, except for the
paragraph immediately preceding the heading “About Neurosense”) 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from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit Index
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.
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NeuroSense Therapeutics Ltd. |
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By: |
/s/ Alon Ben-Noon |
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Name: Alon Ben-Noon |
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Title: Chief Executive Officer |
Date: October 17, 2023
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Exhibit 99.1
NeuroSense CEO Provides Q3 2023 Update
Phase 2b ALS topline results expected December
2023
CAMBRIDGE, Mass., Oct. 17, 2023 /PRNewswire/ -- 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 and immediately
following the third quarter of 2023. The Company’s amyotrophic lateral sclerosis (ALS) Phase 2b PARADIGM trial of PrimeC is expected
to report clinical topline results Q4 2023, and a Phase 2 Alzheimer’s disease study is expected to enroll the first patient in
the next several weeks.
Non-Sponsored Study Demonstrated PrimeC has Outstanding Effect
on ALS Survival (LINK)
| ● | At
the Ichida Stem Cell Lab at University of Southern California, PrimeC was shown to significantly
increase survival rate of induced motor neurons in an in vitro study utilizing induced pluripotent
stem cells (iPSCs) generated from people living with ALS |
| ● | In
another independent study carried out by Dr. Ichida in an Innovative iPSC model, PrimeC performed
among the best in improving motor neuron survival when compared to several other ALS drugs
in development and two ALS FDA approved drugs |
Received SME Status from European Medicines Agency & Opened
Office in Germany (LINK)
| ● | Small
and Medium-Sized Enterprise (SME) status offers regulatory guidance and engagement in
dialogue with EMA |
| ● | Company
plans to enroll patients at multiple sites across Europe in its planned Phase 3 pivotal ALS
study of PrimeC |
Granted Patents in Europe, Japan, and Israel for PrimeC (LINK)
| ● | Patents
valid through 2038 |
Ended At-The-Market Equity Offering Program (LINK)
| ● | Company
is fully funded into Q2 2024 beyond clinical Phase 2b ALS results expected Q4 2023 |
“On October 7, Israel endured an unprecedented brutal attack,
a massacre, by heinous terrorists identifying themselves as Hamas. I’m relieved to report that everyone at NeuroSense is safe.
However, we are heartbroken by this dreadful event and the number of brutally murdered and abducted innocent civilians. In the face of
such terror, NeuroSense’s response remains resolute: we will continue to advance the frontiers of science and invest every effort
into developing effective neurological treatments for those in desperate need, without hesitation. Resilience and unity are key here,
and therefore we are also assisting people in dire need to recover and rebuild,” stated Alon Ben-Noon, CEO of NeuroSense. “NeuroSense
had a very strong third quarter, as we confidently look ahead to reporting Phase 2b ALS clinical results for PrimeC before the end of
the year. The outstanding results from a non-sponsored study of PrimeC in an innovative ALS model further validate the results we’ve
been seeing in our human clinicals and in biomarker and in vitro studies.”
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 cash runway of the Company, the timing of clinical top-line results of,
the results of, the PARADIGM clinical trial and the timing of a Phase 2 study for Alzheirmer’s disease and patient enrollment regarding
a Phase 3 pivotal ALS study of PrimeC. Further, certain forward-looking statements are based on assumptions as to future events that may
not prove to be accurate. 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. These risks include unexpected R&D costs or operating expenses, a delay
in the reporting of clinical top-line results from PARADIGM clinical trial, a delay in patient enrollment for a Phase 2 study for Alzheirmer’s
disease or its planned Phase 3 pivotal ALS study of PrimeC; the potential for PrimeC to safely and effectively target ALS; preclinical
and clinical data for PrimeC; the timing of current and future clinical trials, timing for reporting data; the development and commercial
potential of any product candidates of the company; and other risks and uncertainties set forth in NeuroSense’s filings with the
Securities and Exchange Commission (SEC)., 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 March 22, 2023. 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.
Logo - https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg
Photo - https://mma.prnewswire.com/media/2249474/AlonBN.jpg
For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9
799 6183
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