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NeuroSense Therapeutics Reports Year End 2025 Financial Results and Provides Business Update

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NeuroSense (Nasdaq: NRSN) reported 2025 results and a business update. PrimeC advanced to a late-stage asset with FDA clearance to start the Phase 3 PARAGON trial and Phase 2b PARADIGM showed ~33% slowing of progression over 18 months.

In early 2026 the company reported a 65% reduction in risk of death and a >14-month median survival benefit; results were published in JAMA Neurology. Financials show $0.2M cash at Dec 31, 2025 and a $11.125M net loss for 2025. Key near-term milestones include a May 2026 pre-NDS meeting in Canada and Alzheimer’s readouts.

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Positive

  • FDA clearance to initiate Phase 3 PARAGON
  • 65% reduction in risk of death reported
  • Publication in JAMA Neurology

Negative

  • Cash and cash equivalents of $0.2M at Dec 31, 2025
  • Net loss of $11.125M in 2025
  • Total assets declined from $4.575M to $1.028M

News Market Reaction – NRSN

+3.28%
2 alerts
+3.28% Session close to close
+30.2% Peak Tracked
$26.38M Market Cap
0.1x Rel. Volume

In the Mar 31 session, NRSN gained 3.28%, reflecting a moderate positive market reaction. Argus tracked a peak move of +30.2% during that session. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement combines robust clinical validation for PrimeC, including a 65% reduction in risk ...
Analysis

This announcement combines robust clinical validation for PrimeC, including a 65% reduction in risk of death and >14-month median survival benefit, with detailed 2025 financials showing an $11.125M net loss and cash of about $0.2M. Investors may track how upcoming milestones—such as the planned pre‑NDS meeting in May 2026 and Phase 3 PARAGON preparations—intersect with funding needs under the $150M shelf registration and the company’s ability to address going-concern disclosures.

Key Figures

Risk of death reduction: 65% Median survival benefit: >14 months R&D expenses 2025: $6.2M +5 more
8 metrics
Risk of death reduction 65% Phase 2b ALS survival analysis
Median survival benefit >14 months Phase 2b ALS survival analysis
R&D expenses 2025 $6.2M Year ended Dec 31, 2025
R&D expenses 2024 $5.7M Year ended Dec 31, 2024
G&A expenses 2025 $4.9M Year ended Dec 31, 2025
Net loss 2025 $11.125M Year ended Dec 31, 2025
Cash balance $0.2M As of Dec 31, 2025
Total assets 2025 $1.028M As of Dec 31, 2025

Previous Earnings Reports

5 past events · Latest: Apr 07 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Apr 07 FY 2024 results Positive -2.3% Reported FY 2024 results with strong Phase 2b ALS data and regulatory alignment.
Dec 18 Q3 2024 results Positive +4.6% Q3 2024 update with PARADIGM completion, private placement and FDA feedback.
Jun 24 Q1 2024 results Positive -5.9% Q1 2024 results showing significant slowing of ALS progression and funding raise.
May 02 Q1 2024 update Neutral +0.8% Q1 2024 business update focused on collaborations and PARADIGM progress.
Apr 05 FY 2023 results Neutral -17.5% Year-end 2023 financial results and business update without detailed summary provided.

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

Pattern Detected

Earnings and business updates have often seen negative or muted next-day reactions, even when operational news on PrimeC was positive.

Recent Company History

Across prior earnings-tagged updates since April 2024, NeuroSense has repeatedly paired clinical progress for PrimeC with tight cash positions and ongoing losses. Full-year 2024 results on Apr 07, 2025 highlighted encouraging ALS efficacy and survival signals but still saw a share price decline. Quarterly 2024 updates mixed trial advances, new financing and Canadian commercialization plans with continued net losses. The current 2025 results extend this pattern: stronger late-stage positioning for PrimeC alongside a thin balance sheet.

Key Terms

phase 2b, phase 3, als, biomarker, +4 more
8 terms
phase 2b medical
"Results from the Phase 2b PARADIGM study demonstrated approximately 33% slowing..."
Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.
phase 3 medical
"FDA clearance to initiate the PARAGON Phase 3 trial in ALS..."
Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
als medical
"Phase 3 program in ALSStatistically significant survival benefit demonstrated..."
Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that damages the nerve cells controlling muscles, gradually causing weakness, loss of movement and difficulty breathing — similar to the body’s wiring slowly failing. For investors, ALS matters because research progress, clinical trial results, regulatory approvals or setbacks can dramatically affect the value of companies developing treatments, patient-care markets and related healthcare services.
biomarker medical
"additional biomarker analyses, including microRNA data, supporting the biological activity..."
A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.
microrna medical
"additional biomarker analyses, including microRNA data, supporting the biological activity..."
MicroRNA are tiny molecules inside cells that act like dimmer switches for genes, turning down the production of specific proteins. Investors care because changes in microRNA levels can signal disease, serve as targets for new drugs, or be used as precise diagnostic markers, so advances involving microRNA can affect the value and prospects of biotech and healthcare companies.
median survival medical
"demonstrating a 65% reduction in the risk of death and a greater than 14-month median survival benefit."
Median survival is the amount of time from a defined starting point (like diagnosis or treatment) at which half of a group of patients are still alive and half have died. Investors use it to judge how much a medical treatment or clinical result changes patient outcomes — like measuring the midpoint in a race rather than the average finish time — which affects regulatory approval chances, market size, pricing power, and revenue forecasts.
pre-nds regulatory
"planned pre-NDS meeting in Canada and near-term Alzheimer's readout"
pre-NDS (pre-New Drug Submission) describes the preparatory steps a drug developer takes before formally filing for regulatory approval of a new medicine, including data reviews, regulatory meetings and finalizing study results. For investors, pre-NDS activity is like a company rehearsing and checking equipment before a big product launch: it signals how close the drug is to an official approval request and helps gauge development risk and potential timing for future value milestones.
form 20-f regulatory
"annual report on Form 20-F for the year ended December 31, 2025 has been filed..."
Form 20-F is the standardized annual disclosure that non-U.S. companies must file with the U.S. securities regulator when their shares are traded in the U.S.; it contains audited financial statements, a plain-language description of the business, management discussion, governance details and key risk factors. It matters to investors because it provides a consistent, comparable company “report card” and rulebook, helping buyers assess financial health, governance and risks before investing.

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  • 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.

NeuroSense Therapeutics Logo

"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 per share

$

(0.44)


$         (0.54)


$         (0.74)








Weighted average number of ordinary shares used in computing
     basic net loss per share


25,481,343


18,602,082


13,640,168

 

NeuroSense Therapeutics Ltd.

Consolidated Statements of Changes in Equity (deficit)

(U.S. dollars in thousands, except share and per share data)




Ordinary
Shares

Share
Premium and
Capital

Accumulated

Total
Equity



Number

Amount

Reserve

Deficit

(Deficit)

Balance as of January 1, 2023



11,781,963


$       -


$     21,858


$     (16,014)


$     5,844













Issuance of shares and pre-funded warrants,

net



1,333,600


-


806


-


806

Exercise of pre-funded warrants, options and 

vested RSUs



2,263,479


-


-


-


-

Share based compensation



-


-


1,698


-


1,698

Net loss and comprehensive loss



-


-


-


(10,107)


(10,107)













Balance as of December 31, 2023



15,379,042


$       -


$     24,362


$     (26,121)


$     (1,759)













Issuance of shares and pre-funded warrants,

 net



5,981,238


-


10,806


-


10,806

Exercise of pre-funded warrants, options and

 vested RSUs



1,573,000


-


(*)


-


(*)

Issuance of shares due to SEPA agreement



224,697




281


-


281

Reclassification of warrants into equity



-


-


1,695


(329)


1,366

Bonus accrual reclassification to equity



-


-


1,434


-


1,434

Share-based compensation



70,964


-


665


-


665

Net loss and comprehensive loss



-


-


-


(10,210)


(10,210













Balance as of December 31, 2024



23,228,941


$       -


$     39,243


$     (36,660)

$

$     2,583













Issuance of shares, net



3,546,528


-


4,410


-


4,410

Exercise of options, pre funded warrants and

 vested RSUs



1,583,000


-


22


-


22

Conversion of liability into shares



476,435


-


410


-


410

Share based  compensation



3,722,270


-


2,140


-


2,140

Net loss and comprehensive loss



-


-


-


(11,125)


(11,125













Balance as of December 31, 2025



32,557,174


-


46,225


(47,785)


(1,560

(*) less than $1.

 

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 LinkedInYouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

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 and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS and AD.

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 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.

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 of regulatory filings, reporting of data, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of PrimeC, 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 the uncertainty regarding the timing of regulatory filings, meetings and regulatory decisions; outcomes and the timing of current and future clinical trials; the risk the PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer's disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; 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 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.

Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

 

Cision View original content:https://www.prnewswire.com/news-releases/neurosense-therapeutics-reports-year-end-2025-financial-results-and-provides-business-update-302730062.html

SOURCE NeuroSense

FAQ

What survival benefit did PrimeC show in NeuroSense (NRSN) Phase 2b results?

PrimeC demonstrated a 65% reduction in the risk of death and a greater than 14-month median survival benefit in Phase 2b. According to the company, these results were published in JAMA Neurology and support advancement into a planned Phase 3 PARAGON trial.

Has NeuroSense (NRSN) received regulatory clearance to start a Phase 3 trial for PrimeC?

Yes. NeuroSense received FDA clearance to initiate the PARAGON Phase 3 trial in ALS. According to the company, this clearance marks a key inflection point toward late-stage development and planned PARAGON initiation activities.

What were NeuroSense's (NRSN) cash and net loss figures for year ended December 31, 2025?

NeuroSense reported approximately $0.2 million in cash and a net loss of $11.125 million for 2025. According to the company, cash declined versus 2024 and the net loss reflects R&D and general administrative expenses.

What near-term regulatory milestones should investors expect from NeuroSense (NRSN)?

Investors should expect a planned pre-NDS meeting with Health Canada in May 2026 and a potential NDS submission subject to feedback. According to the company, additional biomarker and Alzheimer’s readouts are also expected soon.

How did the PARADIGM Phase 2b study affect disease progression metrics for PrimeC?

PARADIGM showed approximately 33% slowing in disease progression over 18 months and reductions in ALS complications. According to the company, additional biomarker analyses, including microRNA data, supported PrimeC's biological activity.