-- 2025 marked transition of PrimeC into a late-stage clinical asset with
FDA-cleared Phase 3 program in ALS
-- Statistically significant survival benefit demonstrated, including 65%
reduction in risk of death and >14-month median survival advantage
-- Results published in JAMA Neurology, providing high-level peer-reviewed
validation of clinical and biological activity
-- Advancing toward key regulatory milestones with planned pre-NDS meeting
in Canada and near-term Alzheimer's readout
CAMBRIDGE, Mass., March 31, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense" or the "Company"), a late-stage clinical biotechnology company developing treatments for severe neurodegenerative diseases, today reported its financial results for the year ended December 31, 2025 and provided a business update.
"2025 was a transformational year for NeuroSense, as we advanced PrimeC from a successful Phase 2b program into a late-stage clinical asset with a clear regulatory path forward," said Alon Ben-Noon, Chief Executive Officer of NeuroSense. "As we entered 2026, we further strengthened our clinical and scientific foundation with statistically significant survival data and publication of our results in JAMA Neurology. Together, these milestones position PrimeC as a differentiated therapeutic candidate with the potential to meaningfully impact people with ALS and potentially other neurodegenerative diseases."
Business Highlights from 2025
2025 marked a transformative year for NeuroSense, as the Company advanced PrimeC from a successful Phase 2b program into a late-stage clinical asset with a clearly defined regulatory and development pathway. Results from the Phase 2b PARADIGM study demonstrated approximately 33% slowing in disease progression over 18 months, alongside a substantial reduction in ALS-related complications. During the year, NeuroSense further strengthened its data package through additional biomarker analyses, including microRNA data, supporting the biological activity of PrimeC, supporting PrimeC's potential as a disease-modifying therapy.
The Company also completed commercial-scale manufacturing and advanced its regulatory strategy, including engagement with Health Canada and ongoing partnership discussions.
Importantly, in November 2025, NeuroSense received FDA clearance to initiate the PARAGON Phase 3 trial in ALS, marking a key inflection point in the Company's development trajectory.
NeuroSense also reported early signals of biological activity and statistically significant reductions in key biomarkers associated with Alzheimer's disease, supporting broader potential across neurodegenerative diseases.
Recent Developments and First Quarter 2026 Highlights
Since the beginning of 2026, NeuroSense has continued to strengthen PrimeC's position through significant clinical and scientific milestones. The Company reported statistically significant survival data from its Phase 2b study, demonstrating a 65% reduction in the risk of death and a greater than 14-month median survival benefit.
Further reinforcing the strength of its clinical package, results from the PARADIGM trial were published in JAMA Neurology, highlighting meaningful clinical outcomes and biological activity, including biomarker changes consistent with the proposed mechanism of action.
NeuroSense also expanded its scientific visibility through presentations at leading international conferences and strengthened its intellectual property portfolio with newly granted patents in the United States and internationally. In addition, the Company enhanced its Scientific Advisory Board with leading experts to support continued development in ALS and Alzheimer's disease.
Upcoming Expected Milestones
-- Additional biomarkers readouts from PARADIGM -- Readouts from the Phase 2 Alzheimer's study -- Planned pre-NDS meeting with Health Canada in May 2026 -- Potential NDS submission in Canada, subject to regulatory feedback -- Continued preparation for initiation of the Phase 3 PARAGON trial in ALS
Financial Results
Research and development expenses for the years ended December 31, 2025 and 2024 were $6.2 million and $5.7 million, respectively. The increase of $0.5 million, or 8.8%, was mainly attributed to an increase in share-based payment expenses and increase in our salaries and social benefits expenses which were partly offset by a decrease of our expenses to subcontractors and consultants.
General and administrative expenses for the years ended December 31, 2025 and 2024 were $4.9 million and $4.2 million, respectively. The increase of $0.7 million, or 16.6%, was mainly attributed to an increase in share-based compensation.
As of December 31, 2025, NeuroSense had cash of approximately $0.2 million.
A summary of NeuroSense's consolidated financial results is included in the tables below.
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at https://neurosense.investorroom.com/sec-filings. The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at ir@neurosense-tx.com.
NeuroSense Therapeutics Ltd.
Consolidated Statements of Financial Position
(U.S. dollars in thousands, except share and per share data)
As of December 31,
----------------------
2025 2024
--------- -----------
Assets
Current assets:
Cash and cash equivalents $ 166 $ 3,378
Other receivables 565 989
Restricted deposits 47 35
-------- -----------
Total current assets 778 4,402
-------- -----------
Non-current assets:
Property and equipment, net 58 66
Right of use assets 170 84
Restricted deposit 22 23
-------- -----------
Total non-current assets 250 173
-------- -----------
Total assets $ 1,028 $ 4,575
======== ===========
Liabilities and shareholders' equity
Current liabilities:
Trade payables $ 799 $ 1,160
Other current liabilities 1,717 832
-------- -----------
Total current liabilities 2,516 1,992
-------- -----------
Non-current liabilities:
Lease liability less current maturity 72 -
72 -
-------- -----------
Total liabilities 2,588 1,992
-------- -----------
Shareholders' equity (deficit):
Ordinary shares, no par value:
Authorized: 90,000,000 shares at December 31,
2025 and December 31, 2024; Issued and
outstanding: 32,557,174 and 23,228,941 shares at
December 31, 2025 and December 31, 2024,
respectively - -
Share Premium and Capital Reserve 46,225 39,243
Accumulated deficit (47,785) (36,660)
-------- -----------
Total shareholders' equity (deficit) (1,560) 2,583
-------- -----------
Total liabilities and shareholders' equity $ 1,028 $ 4,575
======== ===========
NeuroSense Therapeutics Ltd.
Consolidated Statements of Income and Comprehensive Loss
(U.S. dollars in thousands, except share and per share data)
For the years ended
December 31
-------------------------------------------
2025 2024 2023
----------- -------------- --------------
Research and development
expenses $ (6,227) $ (5,698) $ (7,274)
General and administrative
expenses (4,858) (4,204) (4,775)
---------- -------------- --------------
Operating loss (11,085) (9,902) (12,049)
---------- -------------- --------------
Financing income
(expenses), net (40) (308) 1,942
---------- -------------- --------------
Net loss and comprehensive
loss $ (11,125) $ (10,210) $ (10,107)
========== ============== ==============
Basic and diluted net loss
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