CAMBRIDGE, Mass., Sept. 25, 2026 /PRNewswire/ -- Therapeutics Ltd. $(NRSN)$ ("NeuroSense" or the "Company"), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today provided a business update with corporate highlights to date and financial results for the first half of 2026.
NeuroSense is advancing PrimeC, its investigational combination therapy for amyotrophic lateral sclerosis (ALS), through regulatory pathways in the United States and Canada while pursuing a focused, capital-efficient late-stage development strategy.
"Our focus remains on advancing PrimeC toward the next stage of development and, ultimately, toward patients," said Alon Ben-Noon, Chief Executive Officer of NeuroSense. "We are working diligently to move our development plans forward in a capital-efficient manner, while pursuing the regulatory, clinical, financing and strategic opportunities available to us. Looking ahead, our priorities include advancing our regulatory pathway in Canada, preparing for the next clinical stage of PrimeC in ALS, and pursuing the funding, partnerships and strategic alternatives that can support the continued development of the program. We remain fully committed to doing everything we can to realize PrimeC's potential to address the significant unmet need in ALS."
Upcoming Corporate Highlights for the Remainder of 2026 include:
-- Targeting December 2026 NDS filing in Canada -- Following completion of
the Pre-New Drug Submission process and finalization of meeting minutes
with Health Canada, NeuroSense is preparing an NDS for PrimeC in ALS and
is targeting December 2026 for submission. Health Canada indicated no
concerns with the proposed filing timeline and provided alignment
regarding the planned content and structure of the submission.
-- Advancing an optimized, capital-efficient U.S. development strategy --
NeuroSense is working toward an optimized path for PrimeC that includes
AI-enabled characterization of PrimeC's proprietary formulation, a
planned active-comparator study against edaravone, and evaluation of a
smaller and shorter pivotal PARAGON design. The Company plans to discuss
with the FDA whether the existing data may support full approval or,
alternatively, an Accelerated Approval pathway. Any revised pivotal
design or regulatory pathway remains subject to FDA alignment.
-- Continued financing and strategic initiatives -- The Company continues to
pursue financing opportunities, including potential non-dilutive funding
sources, and evaluate a range of strategic alternatives, including
potential business and corporate transactions, intended to provide the
resources and strategic framework required to advance PrimeC, while
prioritizing capital-efficient development and preserving long-term
shareholder value.
2026 Corporate Highlights to Date
-- PARADIGM results published in JAMA Neurology and long-term survival
benefit strengthened -- In March 2026, results from the Phase 2b PARADIGM
study were published in JAMA Neurology, providing peer-reviewed
validation of PrimeC's clinical and biological activity. Long-term
follow-up reported in February 2026 showed a statistically significant
65% reduction in the risk of death and an estimated median survival of
36.3 months for participants treated continuously with PrimeC, compared
with 21.4 months for participants initially assigned to placebo before
crossing over to PrimeC.
-- Primary endpoint achieved -- In June 2026, NeuroSense announced that
PARADIGM achieved its primary endpoint, demonstrating a statistically
significant treatment-associated reduction in extracellular
vesicle-associated TDP-43 compared with placebo. TDP-43 pathology is
present in more than 97% of ALS cases, and the finding adds to the
consistent body of evidence observed across clinical outcomes, survival
and multiple disease-relevant biomarkers.
-- Canadian regulatory pathway advanced toward NDS filing -- NeuroSense held
a constructive Pre-NDS meeting with Health Canada and subsequently
completed the Pre-NDS process. Final meeting minutes reflected alignment
on the planned content and structure of the ALS submission, and the
Company is now targeting an NDS filing in early December 2026, supported
by the expanded PARADIGM clinical, survival and biomarker package.
-- Alzheimer's program and global intellectual property portfolio advanced
-- The Phase 2 RoAD proof-of-concept study reported positive biomarker
findings across multiple neurodegenerative disease pathways, providing
early biological evidence consistent with potential target engagement.
NeuroSense also strengthened its Alzheimer's program through a U.S.
patent covering use of PrimeC through 2043 and the addition of Prof.
Steven E. Arnold to its Scientific Advisory Board. During 2026, the
Company further expanded PrimeC composition patent protection through
2042 with grants in Australia, Brazil, Japan and South Korea.
H1 2026 Financial Results:
-- Research and development expenses for the six months ended June 30, 2026
and 2025 were $2,102 thousand and $2,503 thousand, respectively. The
decrease of $401 thousand, or 16%, was mainly attributed to decrease in
our subcontractors and consultants which was offset by an increase in
share-based payment expense.
-- General and administrative expenses for the six months ended June 30,
2026 and 2025 were $1,345 thousand and $2,189 thousand, respectively. The
decrease of $844 thousand, or 38.6%, was mainly attributed to decrease in
professional services.
-- Operating expenses for the six months ended June 30, 2026 and 2025 were
$3.4 million and $4.7 million, respectively due to the reasons described
above.
A summary of NeuroSense's unaudited consolidated financial results is included in the tables below.
NeuroSense Therapeutics Ltd.
Condensed Consolidated balance sheets
------------------------------------------------------------------------
U.S. dollars in thousands
June 30, December 31,
2026 2025
--------- ------------
Assets
Current assets:
Cash and cash equivalent 231 166
Other receivables 540 565
Restricted deposit 73 47
-------- ------------
Total current assets 844 778
-------- ------------
Non-current assets:
Property, plant and equipment, net 52 58
Operating right of use assets - 170
Restricted deposit - 22
-------- ------------
Total non-current assets 52 250
-------- ------------
Total assets 896 1,028
======== ============
Liabilities and Equity
Current liabilities:
Trade payables 729 799
Other current liabilities (*) 2,270 1,717
-------- ------------
Total current liabilities 2,999 2,516
-------- ------------
Non-current liabilities:
Lease liability less current maturity - 72
Total liabilities 2,999 2,588
-------- ------------
Shareholders' equity:
Authorized: 200,000,000 and 90,000,000
shares at June 30, 2026 and December 31,
2025; Issued and
outstanding: 1,836,154 and 1,627,859 shares
at June 30, 2026 and December 31, 2025,
respectively (**) - -
Share premium and capital reserve 49,245 46,225
Accumulated deficit (51,348) (47,785)
-------- ------------
Total Shareholders' deficit (2,103) (1,560)
-------- ------------
Total liabilities and shareholders' deficit 896 1,028
======== ============
(*) Including balance with related parties at the amount of $599
thousand and $602 thousand as of June 30, 2026 and December 31, 2025,
respectively.
(**) After giving effect to the reverse share split, see also note 5.
NeuroSense Therapeutics Ltd.
Condensed Consolidated Statements of Comprehensive Loss
--------------------------------------------------------------------
U.S. dollars in thousands except share and per share data
Six Six
months months
ended ended
June 30, June 30,
2026 2025
---------- ---------
Research and development expenses (2,102) (2,503)
Comments