- 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., Nov. 28,
2023 /PRNewswire/ -- 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.
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
|
|
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