- This notification has no immediate effect on the listing
or trading of NeuroSense's ordinary shares on the
Nasdaq Capital Market
CAMBRIDGE, Mass., Dec. 27,
2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd.
(Nasdaq: NRSN) ("NeuroSense" or the "Company"), a company
developing treatments for severe neurodegenerative diseases, today
announced that it has received a notification from the Listing
Qualifications Department of the Nasdaq Stock Market LLC ("Nasdaq")
advising the Company that it no longer satisfied the minimum
$2.5 million stockholders' equity
requirement for continued listing on Nasdaq set forth in Nasdaq
Listing Rule 5550(b)(1) (the "Minimum Equity Rule") or,
alternatively, the requirement that the Company either maintain a
market value of listed securities of at least $35 million or generate net income from
continuing operations of $500,000 in
the most recently completed fiscal year or two of the last three
most recently completed fiscal years.
The notification from Nasdaq, received on December 21, 2023, has no immediate effect on
NeuroSense's business or the listing or trading of NeuroSense's
ordinary shares which continue to trade on the Nasdaq Capital
Market under the symbol "NRSN."
NeuroSense has 45 days from the date of the notice, or until
February 5, 2024, to submit to Nasdaq
a plan to regain compliance with the Minimum Equity Rule or an
alternative continued listing standard. If the plan is accepted,
Nasdaq may grant an extension of up to 180 calendar days from the
date of the notice, or until June 18,
2024, for the Company to regain compliance.
Alon Ben-Noon, NeuroSense's CEO
stated, "The recent positive results we received from our ALS Phase
2b clinical trial are highly
encouraging and have the potential to open new opportunities for
the Company. We are currently working on a plan to submit to Nasdaq
and intend to regain compliance with Nasdaq's listing rules within
the allotted timeframe. This notification does not affect our
ongoing operations or our commitment to advance PrimeC towards the
market."
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 by 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 ALS that contribute to motor neuron degeneration, inflammation,
iron accumulation and impaired ribonucleic acid ("RNA") regulation
to potentially inhibit the progression of ALS. NeuroSense completed
the 6-month double blind portion of its Phase 2b ALS clinical trial which met its safety and
tolerability endpoints, as well as showing a statistically
significant slowing of disease progression in the pre-specified Per
Protocol (PP) population. Additional data from the Phase
2b study are expected H1 2024. PrimeC
was granted Orphan Drug Designation by the U.S. Food and Drug
Administration and the European Medicines Agency.
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 (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 Company's ability to regain
compliance with the Minimum Equity Rule or an alternative continued
listing standard, the Company's ability to maintain the listing of
its ordinary shares on Nasdaq, PrimeC as a potential treatment for
people with ALS, the timing for release of additional results from
PARADIGM clinical trial, and other regulatory milestones, the
timing for release of results from the Company's strategic
collaboration with Biogen, the cash runway of the Company, the
timing of a Phase 2 trial for Alzheimer's disease and patient
enrollment regarding a Phase 3 pivotal ALS trial 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
additional results from PARADIGM clinical trial; a delay in the
reporting of results from the Company's strategic collaboration
with Biogen; the timing of expected regulatory and business
milestones; risks associated with meeting with the FDA to determine
the best path forward following the results from PARADIGM clinical
trial, including a delay in any such meeting; a delay in patient
enrollment for a Phase 2 trial for Alzheimer's disease or its
planned Phase 3 pivotal ALS trial of PrimeC; the potential for
PrimeC to safely and effectively target ALS; preclinical and
clinical data for PrimeC; the uncertainty regarding outcomes and
the timing of current and future clinical trials; timing for
reporting data; the development and commercial potential of any
product candidates of the company; the success of steps taken to
regain and maintain compliance with Nasdaq's continued listing
standards; 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 SEC
on March 22, 2023 and the Company's
subsequent filings with the SEC. 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.
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