- NeuroSense in Compliance with all Nasdaq Listing
Requirements
CAMBRIDGE, Mass., Jan. 6, 2025
/PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN)
("NeuroSense"), a late-stage clinical biotechnology company
developing novel treatments for severe neurodegenerative
diseases, today announced that the Company received formal written
notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company
has regained compliance with Nasdaq's stockholders' equity
requirement ("Equity Requirement") set forth in Nasdaq Listing Rule
5550(b)(1). The Company's Ordinary Shares will continue to be
listed and trade on The Nasdaq Capital Market under the symbol
"NRSN".
This confirmation follows the Company's successful efforts to
improve its balance sheet by raising new equity and reducing
outstanding liabilities. As a result, NeuroSense shareholders'
equity now exceeds Nasdaq's Equity Requirement of at least
$2.5 million.
Since the Nasdaq hearing on August 1,
2024, NeuroSense has taken several important steps,
including the closing of a $5 million
financing in December 2024.
These steps demonstrate NeuroSense's strong momentum as it
prepares to transition into a pivotal Phase 3 study for PrimeC,
following the promising results of the Phase 2b PARADIGM study.
Alon Ben-Noon, CEO of NeuroSense,
said: "Regaining Nasdaq compliance is a significant milestone that
reflects our dedicated efforts to strengthen the Company's
financial position and ensure continued growth. This achievement
underscores the confidence in our strategic direction and sets a
solid foundation as we advance our pipeline. Our recent
developments, including the binding term sheet to develop PrimeC,
further highlight the progress we are making in addressing the
unmet needs of ALS patients."
As part of the compliance confirmation, NeuroSense will be
subject to a mandatory panel monitor for a year from the date the
letter was received, January 3, 2025.
If, within that one-year monitoring period, the Company fails to
comply with the Equity Requirement, the Company will not be
permitted additional time to regain compliance with the Equity
Requirement. However, the Company will have an opportunity to
request a new hearing with the Nasdaq Listing Qualifications
Hearing Panel prior to a delisting of the Company's securities
from Nasdaq.
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 people
are diagnosed with ALS in the U.S. alone, with an annual disease
burden of $1 billion. The number of people living with ALS is
expected to grow by 24% by 2040 in the U.S. and EU.
About PARADIGM
PARADIGM is a prospective, multinational,
randomized, double-blind, placebo-controlled Phase
2b (NCT05357950) clinical trial of
PrimeC in ALS. The trial included 68 participants living with ALS
in Canada, Italy, and Israel.
During the first 6 months of the trial, 45 participants were
randomized to receive PrimeC, and 23 participants were randomized
to receive placebo. This was followed by a 12-month open-label
extension with all participants receiving PrimeC in a blinded
manner, where neither the participants nor the clinical staff were
aware of the initial treatment allocation.
Most patients enrolled in both the active and placebo arms of
the trial were concurrently treated with Riluzole, the ALS standard
of care medication, indicating PrimeC slowed disease progression
well beyond the level afforded by the FDA approved ALS drug.
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
a Phase 2a clinical trial which met its safety and efficacy
endpoints including reducing functional and respiratory
deterioration and statistically significant changes in ALS-related
biological markers indicating PrimeC's biological activity. 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,
YouTube and X. Information that may be important to
investors may be routinely posted on our website and these social
media channels.
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 growth and the
advancement of its pipeline. 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 the risk of a failure to continue to comply
with the Nasdaq Listing Rules, the risk that the Company will not
grow or advance its pipeline as anticipated, a delay in
commencement of enrollment for the Phase 3 trial, if any, or a
delay in regulatory submissions with the FDA, the risk that the
trial will not be completed, meet regulatory expectations or
provide sufficient data for drug approval, unexpected changes in
trial design, delay in submission by the Company of its regulatory
dossier, that regulatory approvals for PrimeC will be delayed
or not obtained in the U.S., Canada or elsewhere; unsuccessful results of
the Phase 3 trial, unexpected R&D costs or operating expenses,
insufficient capital to complete development of PrimeC, a delay in
the reporting of additional results from PARADIGM clinical trial,
the timing of expected regulatory and business milestones, risks
associated with meeting with the FDA and Health Canada to determine
the best path forward following the results from PARADIGM clinical
trial, including a delay in any such meeting; 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 Neurosense; the ability of NeuroSense to
remain listed on Nasdaq; 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 NeuroSense is contained under the
heading "Risk Factors" in the Annual Report on Form 20-F filed with
the Securities and Exchange Commission on April 4, 2024 and NeuroSense's subsequent filings
with the SEC. Forward-looking statements contained in this
announcement are made as of this date, and NeuroSense undertakes no
duty to update such information except as required under applicable
law.
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SOURCE NeuroSense