NeuroSense Provides Business Update and Progress for the First Half of 2026

NeuroSense is seeking financing and evaluating transactions to support PrimeC’s continued development.

Rhea-AI Summary

NeuroSense (NRSN) reported first-half 2026 results and PrimeC trial progress while targeting a December Canadian regulatory submission.

The Phase 2b PARADIGM study met its primary endpoint in June, showing a statistically significant reduction in extracellular vesicle-associated TDP-43 versus placebo. Long-term follow-up reported in February showed a statistically significant 65% reduction in the risk of death. Estimated median survival was 36.3 months for participants continuously treated with PrimeC, versus 21.4 months for those initially assigned placebo before switching to PrimeC. NeuroSense targets an early December 2026 filing for PrimeC in ALS with Health Canada.

For the six months ended June 30, net loss narrowed to $3.563 million from $4.709 million a year earlier. At June 30, cash was $231,000, current liabilities were $2.999 million, and shareholders' deficit was $2.103 million.

Positive

• PARADIGM primary endpoint met in June 2026
• 65% reduction in risk of death in February follow-up
• First-half net loss narrowed to $3.563 million from $4.709 million

Negative

• $231,000 cash against $2.999 million current liabilities at June 30
• Shareholders' deficit widened to $2.103 million from $1.560 million at year-end 2025
• Outstanding shares rose to 1,836,154 from 1,627,859 at year-end 2025

News Explained

By June 30, NeuroSense had issued shares during H1: outstanding shares stood at 1,836,154, versus 1,627,859 at December 31; its equity table lists 120,483 shares issued net, 14,814 from RSU and pre-funded-warrant exercises, and 72,998 under share-based compensation. These additions reduce existing holders’ percentage ownership absent offsetting changes.

Market Context

The July 30 effective F-3/A listed an ATM program of up to $3,789,822, a registered channel relevant...

Analysis

The July 30 effective F-3/A listed an ATM program of up to $3,789,822, a registered channel relevant to this update's stated funding efforts; recorded shelf usage was zero.

Key Figures

Reduction in risk of death: 65% Estimated median survival: 36.3 months vs. 21.4 months Target NDS filing: December 2026 +3 more

Reduction in risk of death

65%

Long-term follow-up; participants treated continuously with PrimeC

Estimated median survival

36.3 months vs. 21.4 months

Continuous PrimeC treatment vs. participants initially assigned to placebo before crossover

Target NDS filing

December 2026

PrimeC for ALS submission to Health Canada

Research and development expenses

$2,102 thousand vs. $2,503 thousand

Six months ended June 30, 2026 vs. 2025

General and administrative expenses

$1,345 thousand vs. $2,189 thousand

Six months ended June 30, 2026 vs. 2025

Net loss

$3,563 thousand vs. $4,709 thousand

Six months ended June 30, 2026 vs. 2025

Historical Context

2 past events · Latest: Aug 31

2 events

1. Aug 31

   Development strategy

   24h Move

   +4.6%

   Outlined a redesigned PrimeC development strategy, including an optimized pivotal PARAGON study.

2. Aug 06

   Canadian regulatory progress

   24h Move

   -7.2%

   Completed the Pre-NDS process and targeted a December filing with Health Canada.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pre-new drug submission, new drug submission, accelerated approval, active-comparator, +1 more

5 terms

pre-new drug submission regulatory

"Following completion of the Pre-New Drug Submission process"

A pre-new drug submission is a planned discussion between a drug developer and a health regulator that happens before the company files its formal application to market a new medicine. Think of it as a dress rehearsal or checklist review where the regulator flags study gaps, data expectations, and regulatory requirements so the final application is less likely to be rejected or delayed; investors watch these meetings because they reduce uncertainty about approval timelines and costs.

new drug submission regulatory

"targeting December 2026 for submission"

A new drug submission is a formal package of scientific data and paperwork sent to a health authority to request permission to sell a medicine. For investors it signals a key milestone: approval opens the door to sales and revenue, while rejection or delays can cut expected value — think of it like applying for a building permit that determines whether and when a new product can be put on the market.

accelerated approval regulatory

"an Accelerated Approval pathway"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

active-comparator medical

"a planned active-comparator study against edaravone"

An active-comparator is a control in a clinical trial where participants receive an existing, approved treatment rather than a placebo. It lets researchers run a head-to-head comparison of a new drug or therapy against the current standard of care, giving investors clearer information about relative effectiveness and safety—much like comparing a new car model directly against the market leader to see how it stacks up.

tdp-43 medical

"reduction in extracellular vesicle-associated TDP-43 compared with placebo"

TDP-43 is a protein inside cells that helps regulate how genetic instructions are used; when it misfolds or accumulates into clumps in brain or spinal cord cells, it is linked to neurodegenerative conditions like ALS and some dementias. For investors, TDP-43 matters because it is a clear biological target for diagnostics and therapies—detecting or stopping its abnormal behavior could change patient care and create commercial value, similar to fixing a faulty part in a complex machine.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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:

• 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 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.

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SOURCE NeuroSense

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did NeuroSense’s PARADIGM study show for PrimeC?

The Phase 2b study met its primary endpoint in June 2026, with a statistically significant treatment-associated reduction in extracellular vesicle-associated TDP-43 versus placebo. Long-term follow-up reported in February showed a statistically significant 65% reduction in the risk of death.

What has Health Canada said about NeuroSense’s planned PrimeC submission?

Health Canada indicated no concerns with the proposed filing timeline and aligned with NeuroSense on the planned content and structure of its ALS submission. NeuroSense completed the Pre-New Drug Submission process and targets a filing in early December 2026.

What U.S. development steps is NeuroSense considering for PrimeC?

NeuroSense plans an active-comparator study against edaravone and is evaluating a smaller, shorter pivotal PARAGON trial design. It plans to discuss with the FDA whether existing data could support full approval or an Accelerated Approval pathway. Any revised trial design or regulatory pathway remains subject to FDA alignment.

How did NeuroSense’s first-half 2026 operating expenses change?

Research and development expenses fell 16% to $2.102 million from $2.503 million a year earlier. General and administrative expenses fell 38.6% to $1.345 million from $2.189 million. The periods are the six months ended June 30, 2026 and 2025.