NeuroSense Provides Business Update and Progress for the First Half of 2026
CAMBRIDGE, Mass., Sept. 25, 2026 /PRNewswire/ -- Therapeutics Ltd. (NASDAQ: 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:
2026 Corporate Highlights to Date
H1 2026 Financial Results:
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
months
ended
June 30,
2026
Six
months
ended
June 30,
2025
Research and development expenses
(2,102)
(2,503)
General and administrative expenses
(1,345)
(2,189)
Operating loss
(3,447)
(4,692)
Financing expenses, net
(116)
(17)
Net loss and comprehensive loss
(3,563)
(4,709)
Basic and diluted net loss per share (*)
(2.1)
(3.7)
Weighted average number of shares outstanding used in computing basic and
diluted net loss per share (*)
1,731,255
1,270,132
(*) After giving effect to the reverse share splits, see also note 5.
NeuroSense Therapeutics Ltd.
Condensed Consolidated Statements of Changes in Shareholders' deficit
U.S. dollars in thousands (except for share and per share data)
Ordinary shares
Share
premium
and
capital
Accumulated
Total
Number
(*)
Amount
reserve
deficit
equity
Balance as of January 1, 2026
1,627,859
$
-
$
46,225
$
(47,785)
$
(1,560)
Issuance of shares, net
120,483
-
2,066
-
2,066
Exercise of RSus and pre-funded warrants
14,814
-
**
)
-
**
)
Share-based compensation
72,998
-
954
-
954
Net loss and comprehensive loss
-
-
-
(3,563)
(3,563)
Balance as of June 30, 2026
1,836,154
$
-
$
49,245
$
(51,348)
$
(2,103)
(*) After giving effect to the share splits and the reverse share splits, see also note 5.
(**) Less than $1 thousand.
About ALS
Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within approximately 3 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 is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer's disease. The Company's lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.
NeuroSense has recently completed analysis of long-term follow-up data from its Phase 2b PARADIGM study in ALS, with results published in JAMA Neurology showing slowing of functional decline relative to placebo. The Company also reported changes across multiple biomarkers associated with ALS, including microRNAs, consistent with PrimeC's multi-target mechanism of action.
NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate its pivotal Phase 3 clinical trial (PARAGON) in ALS, to be conducted primarily in the United States. As described above, the Company is working with FDA on an optimized design for the study.
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 in this press release include, among other things, statements regarding the Company's planned Canadian New Drug Submission for PrimeC, the regulatory pathway and future development of PrimeC, including the Company's planned U.S. development strategy, potential clinical trials and regulatory interactions, the potential benefits of PrimeC, the Company's financing activities and capital resources, potential collaborations, partnerships and strategic transactions, and the Company's future business, operational and strategic plans.
Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Actual results could differ materially from those anticipated or implied by such statements as a result of various risks and uncertainties, including, among others, risks relating to the Company's ability to obtain additional financing; the timing, outcome and costs of regulatory submissions, interactions and approvals; the timing, design, initiation, conduct and results of clinical trials; the possibility that existing clinical, survival or biomarker data may not support future development or regulatory objectives; the Company's ability to execute its development strategy; the availability of strategic, partnering or financing opportunities; the Company's ability to maintain compliance with Nasdaq listing requirements; and other risks and uncertainties described in the Company'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 March 31, 2026 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.
SOURCE NeuroSense