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 November 2023
Commission File Number: 001-41084
NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)
11 HaMenofim Street, Building B
Herzliya 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
☐
On
November 28, 2023, NeuroSense Therapeutics Ltd. (the “Company”) issued a press release announcing the Company’s
third Quarter 2023 financial results and providing a business update. A copy of the press release is furnished herewith as Exhibit
99.1.
This Report
on Form 6-K (other than the second paragraph in Exhibit 99.1) is hereby incorporated by reference into the registrant’s Registration
Statements on Form S-8 (File No. 333-262480) and Form F-3 (File No. 333-269306), 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is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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
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: November 28, 2023 |
By: |
/s/ Alon Ben-Noon |
|
|
Alon Ben-Noon |
|
|
Chief Executive Officer |
2
Exhibit 99.1
NeuroSense Announces Third Quarter 2023 Financial
Results and Provides Business Update
| ● | Topline
clinical secondary efficacy results and primary safety endpoints from Phase 2b ALS trial (PARADIGM) expected in early December 2023 |
| ● | Patients
who completed the 18-month PARADIGM trial, including the 6-month double-blind study plus the 12-month open label extension, have requested
to continue treatment with PrimeC |
| ● | First
patient in Phase 2 Alzheimer’s disease study expected to be enrolled December 2023 |
| ● | Cash
runway beyond topline clinical study readouts, into Q2 2024 |
CAMBRIDGE,
Mass., November 28, 2023 -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a company developing treatments
for severe neurodegenerative diseases, today reported its financial results for the nine months ended September 30, 2023 and provided
a business update.
“In early December, we look forward to reporting
topline clinical results from our Phase 2b ALS study. Additional data, including the biomarker results from our collaboration with Biogen
and primary biomarker endpoints are expected within the first half of 2024. We believe that positive results would offer substantial hope
to people living with ALS and would put PrimeC well on its path to a pivotal Phase 3 for regulatory approval,” stated NeuroSense’s
CEO, Alon Ben-Noon. “With a cash runway extending towards the end of Q2 2024, we believe we are well positioned, upon a positive
read out from the study, to advance our discussions with potential strategic partners.”
Business Update
Phase 2b Amyotrophic Lateral Sclerosis (ALS)
PARADIGM Trial Completed Double-Blind Segment
In November 2023, NeuroSense completed the 6-month
double-blind segment of PARADIGM, a placebo-controlled, multi-center Phase 2b clinical trial using a unique upgraded formulation of PrimeC,
which is designed to maximize the synergistic effect between the compounds in its combination drug. 96% of participants who completed
the double-blind segment of the trial chose to continue in the study and be treated with PrimeC through a 12-month open-label extension.
All participants who have completed the 18-month trial to date requested to continue treatment with PrimeC. NeuroSense supplies the drug
to the participants through an Investigator Initiated Trial (IIT) and will continue to provide PrimeC to any participant who completes
the trial and requests to stay on the Company’s investigational ALS medication.
PARADIGM’s secondary clinical endpoints
which are expected to be reported in December 2023 include: Amyotrophic Lateral Sclerosis Functional
Rating Scale-Revised (ALSFRS-R), Slow Vital Capacity (SVC), and overall survival to demonstrate an attenuation in disease progression.
NeuroSense also expects to report primary safety and tolerability results from the double-blind segment of the trial in December 2023.
U.S. FDA Confirmed CMC Strategy for PrimeC
Ahead of Pivotal Phase 3 for Commercial Readiness
NeuroSense recently concluded a successful Type
D meeting with the U.S. Food and Drug Administration (FDA) for PrimeC in the treatment of ALS. FDA Type D meetings are focused on a narrow
set of issues at key decision points to provide timely feedback critical to move a drug development program forward. The purpose of NeuroSense’s
meeting with the FDA was to discuss PrimeC’s chemistry, manufacturing, and controls (CMC) development plans in advance of an expected
Phase 3 pivotal study and potential subsequent marketing approval. The FDA agreed with NeuroSense’s proposed CMC development plan, setting
the stage for a smooth progression with the production PrimeC for a Phase 3 and subsequent commercialization.
Non-Sponsored Study Demonstrated PrimeC’s
Outstanding Effect on ALS Survival
At the Ichida Stem Cell Lab at University of Southern
California, PrimeC was shown to significantly increase the 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 two FDA approved ALS drugs
as well as several other ALS drugs in development. Together, these results reinforce previous findings on PrimeC’s efficacy and
mechanism of action.
Phase 2 Alzheimer’s Disease (AD) Trial Under
Preparation, First Patient Enrolled Expected in Q4 2023
NeuroSense published data from a biomarker study
which revealed elevated levels of novel biomarker TDP-43 in AD as compared to healthy controls in the first quarter of 2023. These results
demonstrate the therapeutic potential of NeuroSense’s combination drug platform for AD. Currently, NeuroSense is preparing a Phase
2 double-blind proof-of-concept clinical study in AD. Regulatory submissions and site readiness have been ongoing during Q3 2023 and the
first patient enrolled is expected in December 2023.
Patents Granted in Europe, Japan, and Israel
for PrimeC Valid Through 2038
Patents have been granted in Europe, Japan, and
Israel for a key patent relating to “Compositions comprising an anti-inflammatory drug and a dicer activator for use in treatment
of neuronal diseases.” These patents address NeuroSense’s unique fixed-dose combination of ciprofloxacin and celecoxib, two FDA approved
drugs that are the active ingredients in PrimeC.
SME Status Received from European Medicines
Agency & NeuroSense Opens EU Office
The European Medicines Agency’s (EMA) Small
and Medium-Sized Enterprise (SME) status offers NeuroSense regulatory guidance and engagement in dialogue with the EMA. The Company plans
to enroll patients at multiple sites across Europe in its planned Phase 3 pivotal ALS study of PrimeC. As Europe is a key market, in addition
to the U.S., NeuroSense opened an office in Ulm, Germany to lead its regulatory dialogue with the EMA and clinical operations during the
planned Phase 3 study.
Financial Summary
| ● | Research
and development expenses for the nine months ended September 30, 2023 increased to $5.6 million compared
to $4.9 million for the nine months ended September 30, 2022. This increase was primarily attributable to an increase
in expenses to subcontractors and consultants as well as salaries and social benefits as a result of the commencement of a Phase 2b ALS
clinical study in the second quarter of 2022, which were partially offset by a decrease in share-based compensation expenses. NeuroSense
expects research and development expenses will remain steady through 2023. |
| ● | General
and administrative expenses for the nine months ended September 30, 2023 decreased to $4.4 million compared
to $5.3 million for the nine months ended September 30, 2022. This decrease was primarily attributable to a decrease in
directors and officers insurance expenses and share-based compensation, which were partially offset primarily by an increase in payroll
and related expenses. NeuroSense expects that general and administrative expenses will remain steady through 2023. |
| ● | Operating expenses for the nine months ended September 30,
2023 were $10.02 million compared to $10.17 million for the nine months ended September 30, 2022 due
to the reasons described above. |
As of September 30, 2023, NeuroSense
had cash of approximately $4.8 million.
In October 2023, the Company terminated its
previously established “at-the-market” (“ATM”) equity offering program.
A summary of NeuroSense’s unaudited consolidated
financial results is included in the tables below.
About ALS
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.
About PrimeC
PrimeC, NeuroSense’s lead drug candidate, is a
novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib.
PrimeC is designed to synergistically target several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron
degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS. PrimeC was granted
Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
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 X,
formerly known as 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 for release of results
from the double-blind segment of the Company’s Phase 2b trial, the timing of enrollment of the first patient in the Phase 2
Alzheimer’s disease study, the cash runway and regarding an expected Phase 3 pivotal study. 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 a delay in the reporting of results from PARADIGM clinical trial, the failure to meet the primary or secondary endpoints of
the trial, a delay in patient enrollment for a Phase 2 trial for Alzheimer’s disease or its planned Phase 3 pivotal ALS trial of
PrimeC; incurrence of greater than anticipated expenses; 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.
For further information: For further information:
Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited Statements of Financial
Position
U.S. dollars in thousands
| |
September 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Assets | |
| | |
| |
Current assets: | |
| | |
| |
Cash | |
| 4,759 | | |
| 3,543 | |
Short term deposits | |
| - | | |
| 3,547 | |
Other receivables | |
| 309 | | |
| 255 | |
Restricted deposit | |
| 37 | | |
| 36 | |
Total current assets | |
| 5,105 | | |
| 7,381 | |
| |
| | | |
| | |
Non-current assets: | |
| | | |
| | |
Property, plant and equipment, net | |
| 88 | | |
| 77 | |
Right of use assets | |
| 172 | | |
| 229 | |
Non-current restricted deposit | |
| 21 | | |
| 23 | |
Total non-current assets | |
| 281 | | |
| 329 | |
| |
| | | |
| | |
Total assets | |
| 5,386 | | |
| 7,710 | |
| |
| | | |
| | |
Liabilities and Equity | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Trade payables | |
| 913 | | |
| 498 | |
Other payables | |
| 1,896 | | |
| 1,228 | |
Total current liabilities | |
| 2,809 | | |
| 1,726 | |
| |
| | | |
| | |
Non Current liabilities: | |
| | | |
| | |
Long term lease liability | |
| 84 | | |
| 147 | |
Liability in respect of warrants and pre-funded warrants | |
| 2,689 | | |
| 218 | |
| |
| 2,773 | | |
| 365 | |
| |
| | | |
| | |
Total liabilities | |
| 5,582 | | |
| 2,091 | |
| |
| | | |
| | |
Shareholders’ equity: | |
| | | |
| | |
Ordinary shares | |
| - | | |
| - | |
Share premium and capital reserve | |
| 28,920 | | |
| 26,405 | |
Accumulated deficit | |
| (29,116 | ) | |
| (20,786 | ) |
Total Shareholders’ equity (deficit) | |
| (196 | ) | |
| 5,619 | |
| |
| | | |
| | |
Total liabilities and shareholders’ equity (deficit) | |
| 5,386 | | |
| 7,710 | |
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited Statements of Income
and Comprehensive Loss
U.S. dollars in thousands except share and
per share data
| |
Nine months | | |
Nine months | | |
For the year | |
| |
ended | | |
ended | | |
ended | |
| |
September 30, | | |
September 30, | | |
December 31, | |
| |
2023 | | |
2022 | | |
2022 | |
| |
| | |
| | |
| |
Research and development expenses | |
| (5,630 | ) | |
| (4,872 | ) | |
| (6,416 | ) |
| |
| | | |
| | | |
| | |
General and administrative expenses | |
| (4,385 | ) | |
| (5,301 | ) | |
| (7,136 | ) |
| |
| | | |
| | | |
| | |
Operating loss | |
| (10,015 | ) | |
| (10,173 | ) | |
| (13,552 | ) |
| |
| | | |
| | | |
| | |
Financing expenses | |
| (2,208 | ) | |
| (68 | ) | |
| (45 | ) |
| |
| | | |
| | | |
| | |
Financing income | |
| 3,893 | | |
| 1,051 | | |
| 1,257 | |
| |
| | | |
| | | |
| | |
Financing income, net | |
| 1,685 | | |
| 983 | | |
| 1,212 | |
| |
| | | |
| | | |
| | |
Net loss and comprehensive loss | |
| (8,330 | ) | |
| (9,190 | ) | |
| (12,340 | ) |
Basic and diluted net loss per share | |
| (0.67 | ) | |
| (0.8 | ) | |
| (1.07 | ) |
Weighted average number of shares outstanding used in computing basic and diluted net loss per share | |
| 12,464,189 | | |
| 11,394,085 | | |
| 11,504,521 | |
NeuroSense Therapeutics Ltd.
Condensed
Interim Unaudited Statements of Changes in Equity
U.S. dollars in thousands
| |
Ordinary | | |
Share Premium And Capital | | |
Accumulated | | |
Total Equity | |
| |
Shares | | |
Reserve | | |
Deficit | | |
(Deficit) | |
Nine months ended September 30, 2023: | |
| | |
| | |
| | |
| |
| |
| | |
| | |
| | |
| |
Balance as at January 1, 2023 | |
| - | | |
| 26,405 | | |
| (20,786 | ) | |
| 5,619 | |
Share-based compensation | |
| - | | |
| 2,510 | | |
| - | | |
| 2,510 | |
Exercise of options | |
| - | | |
| 5 | | |
| - | | |
| 5 | |
Net loss and comprehensive loss | |
| - | | |
| - | | |
| (8,330 | ) | |
| (8,330 | ) |
| |
| | | |
| | | |
| | | |
| | |
Balance as at September 30, 2023 | |
| - | | |
| 28,920 | | |
| (29,116 | ) | |
| (196 | ) |
Nine months ended September 30, 2022: | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Balance as at January 1, 2022 | |
| - | | |
| 17,452 | | |
| (8,446 | ) | |
| 9,006 | |
Share-based compensation | |
| - | | |
| 3,812 | | |
| - | | |
| 3,812 | |
Net loss and comprehensive loss | |
| - | | |
| - | | |
| (9,190 | ) | |
| (9,190 | ) |
Cancelation of options | |
| | | |
| (96 | ) | |
| - | | |
| (96 | ) |
Exercise of warrants | |
| - | | |
| 4,314 | | |
| - | | |
| 4,314 | |
| |
| | | |
| | | |
| | | |
| | |
Balance as at September 30, 2022 | |
| - | | |
| 25,482 | | |
| (17,636 | ) | |
| 7,846 | |
For the year ended December 31, 2022: | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Balance as at January 1, 2022 | |
| - | | |
| 17,452 | | |
| (8,446 | ) | |
| 9,006 | |
Share-based compensation | |
| - | | |
| 4,735 | | |
| - | | |
| 4,735 | |
Net loss and comprehensive loss | |
| - | | |
| - | | |
| (12,340 | ) | |
| (12,340 | ) |
Cancelation of options | |
| - | | |
| (96 | ) | |
| - | | |
| (96 | ) |
Exercise of warrants | |
| - | | |
| 4,314 | | |
| - | | |
| 4,314 | |
| |
| | | |
| | | |
| | | |
| | |
Balance as at December 31, 2022 | |
| - | | |
| 26,405 | | |
| (20,786 | ) | |
| 5,619 | |
6
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