Release – NeuroSense Files U.S. Patent Application for Traumatic Brain Injury

CAMBRIDGE, Mass., Oct. 19, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense” or the “Company”), a late-stage clinical biotechnology company developing treatments for neurodegenerative diseases, today announced that it has filed a patent application with the U.S. Patent and Trademark Office covering methods of treating traumatic brain injury (TBI) and related central nervous system injuries with the combination of ciprofloxacin and celecoxib, the active ingredients of PrimeC.

The application covers the treatment of a broad range of brain injuries, from concussion and mild TBI to moderate and severe TBI, including blast-related injury, as well as their long-term consequences, such as chronic traumatic encephalopathy (CTE). If granted, the patent is expected to provide protection through 2047, subject to any extensions.

Traumatic brain injury (TBI) represents a major global healthcare challenge, affecting millions of people each year. TBI can result from falls, motor vehicle accidents, sports-related injuries and military-related trauma, including blast exposure. Its consequences can extend well beyond the initial event, potentially causing persistent cognitive, physical and behavioral impairment, with substantial burdens on patients, caregivers and healthcare systems. Despite this significant unmet medical need, there are currently no approved disease-modifying therapies specifically targeting the secondary neurological injury associated with TBI.

Following the initial trauma, TBI can trigger complex biological processes, including neuroinflammation, oxidative stress and progressive neuronal damage. Certain mechanisms overlap with pathways implicated in neurodegenerative disorders.

The patent filing also supports NeuroSense’s longer-term strategy of pursuing additional applications for PrimeC beyond its existing development programs. The Company views TBI as an opportunity to broaden PrimeC’s commercial potential and build additional long-term value around its lead asset. While ALS remains NeuroSense’s primary development priority, the Company is evaluating future TBI-focused research and development initiatives, through strategic collaborations, research grants and other non-dilutive funding opportunities.

“While ALS remains our primary focus, we believe PrimeC may have potential across a broader range of neurological conditions that share common underlying disease mechanisms,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “TBI is a particularly compelling area given the large affected population, the long-term consequences of brain injury and the lack of approved disease-modifying treatments. This filing strengthens our intellectual property position and creates a foundation for future research, partnerships and non-dilutive funding opportunities, while maintaining our focus on advancing our core ALS program. We look forward to sharing further updates as our clinical and strategic initiatives advance.”

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 slower functional decline in participants who received PrimeC from study start than in those who initially received 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. 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.

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 target several key mechanisms that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation, with the potential to inhibit disease progression.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes progressive paralysis and, typically, death within 3 years of symptoms onset. 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 Company’s development program, including for ALS and TBI, the potential issuance, scope and duration of patent protection arising from the Company’s patent application, including expected protection through 2047, subject to any extensions, the potential of PrimeC to treat TBI and related central nervous system injuries, the potential expansion of PrimeC beyond ALS and its potential commercial benefits and long-term value. Further, certain forward-looking statements 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 risk that the patent application will not result in an issued patent or that any patent granted will not provide the Company with the anticipated scope or duration of protection or will be challenged, invalidated or unenforceable; the risk that PrimeC will not demonstrate safety or efficacy in TBI or related conditions; the potential for delay in the timing of the Phase 3 clinical trial (PARAGON) in ALS; the risk that the Company will not be able to obtain financing on acceptable terms, or at all; the risk that the Company will not regain and maintain compliance with the Nasdaq listing requirements; the risk that non-dilutive grant funding for the PARAGON trial will not be awarded or will be delayed; uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that 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; 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.

SOURCE NeuroSense

For further information: For further information: Email: [email protected] | Tel: +972-(0)9-799-6183

Release – NeuroSense Secures Nasdaq Hearing Date as PrimeC Approaches Key Regulatory and Funding Milestones

Research News and Market Data on NRSN

Shares continue to trade on Nasdaq pending the Panel’s decision; minimum bid price compliance already regained

Near-term catalysts include a New Drug Submission to Health Canada targeted for December 2026 and a decision on non-dilutive funding for the Phase 3 PARAGON trial expected in Q1 2027

CAMBRIDGE, Mass., Oct. 13, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense” or the “Company”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that its hearing before the Nasdaq Hearings Panel (the “Panel”) is scheduled for November 10, 2026, following its timely appeal of the October 1, 2026 Staff Delisting Determination.

The appeal stays the suspension and delisting action, and NeuroSense’s ordinary shares and warrants are expected to continue trading on The Nasdaq Capital Market under “NRSN” and “NRSNW,” respectively, pending the Panel’s decision.

Management Commentary

“With bid-price compliance regained, we look forward to presenting the Panel with our plan to achieve full compliance, while advancing PrimeC toward several important near-term milestones,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense.

“PrimeC’s Phase 2b results, published in JAMA Neurology, and FDA clearance to initiate PARAGON provide a strong foundation for the next stage of development. Over the coming months, we expect to file our New Drug Submission with Health Canada and receive a decision on non-dilutive grant funding that, if awarded, could support Phase 3 development while reducing our reliance on equity financing. We are also pursuing strategic business development opportunities.”

Plan to Regain Nasdaq Compliance

NeuroSense has regained compliance with Nasdaq’s $1.00 minimum bid price requirement. The only remaining deficiency identified in the October 1 Staff Determination is the $35 million minimum market value of listed securities requirement under Rule 5550(b)(2).

At the hearing, the Company intends to present its plan to meet that requirement or the alternative $2.5 million stockholders’ equity standard under Rule 5550(b)(1), including proposed measures to strengthen its balance sheet and stockholders’ equity, together with implementation timelines.

NeuroSense intends to request an exception period to execute its plan. The Panel may grant an exception of up to 180 days from the October 1 Staff Determination, but there is no assurance that an exception will be granted or that the Company will regain and maintain compliance.

Upcoming PrimeC Milestones

  • Health Canada New Drug Submission for PrimeC in ALS: targeted for December 2026.
  • Decision on non-dilutive grant funding for Phase 3 PARAGON: expected in Q1 2027, subject to completion of the ongoing grant review.

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 slower functional decline in participants who received PrimeC from study start than in those who initially received 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. 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.

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 target several key mechanisms that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation, with the potential to inhibit disease progression.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes progressive paralysis and, typically, death within 3 years of symptoms onset. 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 Nasdaq hearing process, the continued listing and trading of the Company’s securities pending the Panel’s decision, the Company’s request for an exception period, the Company’s plan to regain compliance with Nasdaq’s continued listing requirements, including through compliance with the minimum market value of listed securities requirement or the alternative stockholders’ equity standard, the Company’s proposed measures to strengthen its balance sheet and stockholders’ equity and the timing and effectiveness of such measures, the anticipated milestones described in this press release and their timing, including the anticipated timing of the Company’s New Drug Submission to Health Canada and a decision regarding potential non-dilutive grant funding for the Phase 3 PARAGON trial, the potential receipt, timing and amount of such funding and its potential ability to support Phase 3 development and reduce the Company’s reliance on equity financing, the Company’s pursuit of strategic business development opportunities and the potential benefits thereof, and the potential of PrimeC. Further, certain forward-looking statements, including statements regarding the potential regulatory pathways for 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 potential for delay in the timing of the Phase 3 clinical trial (PARAGON) in ALS; potential delay in the Canadian New Drug Submission; the risk that the Company will not be able to obtain financing on acceptable terms, or at all; the risk that the Company will not regain and maintain compliance with the Nasdaq listing requirements; the risk that the Panel will not grant the Company’s request for an exception period; the risk that non-dilutive grant funding for the PARAGON trial will not be awarded or will be delayed; the risk that the strategic opportunities described will not materialize or result in the anticipated benefits to the Company; uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that 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; 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.

SOURCE NeuroSense

For further information: For further information: [email protected], Tel: +972 (0)9 799 6183; Investor Relations: Or Eisenberg, [email protected], Tel: +1315517554134

NeuroSense Therapeutics Ltd. (NRSN) – NeuroSense Announces Target Date For Canadian PrimeC Approval Application


Tuesday, August 11, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Pre-Application Process Has Been Completed. NeuroSense announced that it has completed Pre-NDS meetings with Health Canada and plans to submit a New Drug Submission (NDS) for PrimeC in its ALS indication. These meetings focused on whether the data could support approval and the submission requirements. The target date is December 2026. We see this as good news that is consistent with our expectations.

We View The Canadian NDS Process As An Important Milestone For PrimeC. The NDS application will include the Phase 2b PARADIGM trial data, with additional preclinical and supporting data. The primary endpoint in the trial showed a reduction in TDP-43 (TAR DNA-binding Protein 43, a protein that drives ALS progression and deterioration). The data also showed increased median survival, improved functional assessments, biomarkers showing slower disease progression, as well as safety and tolerability. Approval would be based on Health Canada’s analysis of these data.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – NeuroSense Advances PrimeC Toward New Drug Submission to Health Canada for ALS

Research News and Market Data on NRSN

The planned submission follows alignment with Health Canada on the NDS pathway and is supported by additional PARADIGM data, including a survival benefit and consistent effects across PrimeC’s multi-pathway biomarker program

CAMBRIDGE, Mass., July 22, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced it intends to proceed with the filing of a New Drug Submission (NDS) to Health Canada (the “Agency”) for PrimeC for the treatment of amyotrophic lateral sclerosis (ALS), following a constructive Pre-New Drug Submission (“Pre-NDS”) meeting with the Agency. NeuroSense expects to complete and file the submission in the coming months.

    The recent Pre-NDS meeting was held following the generation of substantial additional evidence from the Phase 2b PARADIGM clinical program. NeuroSense presented Health Canada with a comprehensive update to its proposed NDS package, including achievement of the study’s prespecified primary TDP-43 biomarker endpoint (p=0.0421), long-term survival (14.9-month median survival benefit, HR 0.35 and p=0.0037), external natural history analyses, and additional mechanistic and translational data generated since the Company’s initial regulatory interaction. The meeting also included an expert clinical perspective from a leading Canadian ALS specialist, as well as additional supportive analyses that will form part of the planned NDS package, further strengthening the growing body of evidence supporting PrimeC’s potential in ALS.

    “This marks an important milestone in our regulatory strategy for PrimeC,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “The additional evidence generated through the PARADIGM program – from achievement of the primary TDP-43 biomarker endpoint to the meaningful long-term survival outcome – has significantly strengthened our planned submission package and reinforces our confidence in PrimeC’s potential to address the substantial unmet need faced by people living with ALS. We appreciate Health Canada’s constructive engagement throughout the Pre-NDS process and look forward to completing our submission.”

    NeuroSense plans to continue to work with Health Canada as it prepares the NDS filing, and looks forward to providing further updates as the submission advances.

    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, supporting meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action. and representing a potentially important advance in the treatment of ALS.

    NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

    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.

    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 including statements regarding regulatory plans and the timing thereof in Canada and the future development of PrimceC. 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 potential of PrimeC. Further, certain forward-looking statements 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 risk that the potential NDS submission will be delayed or not occur; the uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that 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

    SOURCE NeuroSense

    For further information: For further information: Email: [email protected] | Tel: +972 (0)9 799 6183

    NeuroSense Therapeutics Ltd. (NRSN) – Strong PrimeC Data Continues As Phase 2b PRAADIGM Study Meets Primary Endpoint In ALS With Reduction


    Thursday, July 02, 2026

    Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

    Refer to the full report for the price target, fundamental analysis, and rating.

    NeuroSense Reported Strong Phase 2b PARADIGM Data. Results of the Phase 2b PARDIDM study testing PrimeC in ALS met its primary endpoint of a statistically significant reduction in TDP-43 at six months. The reduction in neuron-derived TDP-43 in the treated group indicates that PrimeC affects an important mechanism of disease and the underlying cause of ALS. To our knowledge, this is the first clinical trial to show that a drug could reduce TDP-43 in people living with ALS.

    Phase 2b PARADIGM Study Tested Functional and Biological Endpoints. The trial was a double-blind trial enrolling 68 patients with confirmed ALS. Patients were randomized 2:1 to receive either PrimeC or a placebo for 6 months. All patients then received PrimeC for the next 12 months (18 months total). The trial endpoints included TDP-43, safety, tolerability,  and biomarkers of disease.


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    This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

    *Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

    Release – NeuroSense Achieves Primary Endpoint in Phase 2b ALS Study with Statistically Significant Reduction of TDP-43, the Defining Pathological Hallmark of ALS

    Research News and Market Data on NRSN

    • First randomized, double-blind, placebo-controlled trial to demonstrate treatment-associated reduction of TDP-43 in people living with ALS
    • TDP-43 pathology is present in more than 97% of ALS cases and is widely recognized as a central driver of disease progression
    • PrimeC demonstrates target engagement with consistent effects across clinical outcomes, survival, and biomarkers, supporting its potential as a disease-modifying therapy

    CAMBRIDGE, Mass., June 29, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that its Phase 2b PARADIGM study of PrimeC in amyotrophic lateral sclerosis (ALS) has successfully met its primary efficacy endpoint, demonstrating a statistically significant reduction in TDP-43 levels compared to placebo. This is the first randomized, double-blind, placebo-controlled clinical study to demonstrate a treatment-associated reduction in TDP-43 in people living with ALS. The analysis was performed using the NeuroDex ExoSORT procedure, an immunoaffinity-based methodology that selectively isolates neuron-derived extracellular vesicles (NDEs). This approach enables measurement of neuron-derived TDP-43, providing a CNS-relevant signal that can be distinguished from TDP-43 released by non-neuronal cells and peripheral tissues.

    TDP-43 is the defining pathological hallmark of ALS, present in more than 97% of cases, and is widely recognized as a central driver of disease progression. The observed reduction in TDP-43 provides biological evidence that PrimeC is engaging a core disease mechanism.

    Primary Efficacy Endpoint Achieved with Statistical Significance

    The randomized, double-blind, placebo-controlled Phase 2b PARADIGM study evaluated the safety, tolerability, biomarkers and efficacy of PrimeC in people with ALS. At Day 180, the pre-specified primary endpoint timepoint, PrimeC produced a statistically significant reduction in TDP-43 versus placebo (p=0.0421). The effect was sustained and deepened over the full 18 months of the study, with continuously treated PrimeC participants maintaining lower TDP-43 levels than the placebo arm at Day 540 (p<0.001).

    These findings build upon previously reported clinical outcomes from the PARADIGM study, including:

    • Statistically significant slowing of ALSFRS-R decline at 12 and 18 months (36.5%, p=0.008; 32.8%, p=0.007)
    • Statistically significant ~15-month median survival benefit (HR 0.35, p=0.004)
    • Consistent modulation of TDP-43, iron-regulatory and ALS-associated microRNA, supporting multi-target engagement
    • Favorable safety and tolerability profile with no new safety signals observed over up to 18 months of treatment

    “Achieving the primary endpoint of PARADIGM with a statistically significant reduction in TDP-43 marks a defining moment for NeuroSense and for ALS research,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “For decades, TDP-43 has been recognized as the pathological signature of ALS, yet demonstrating a treatment-associated reduction in people with ALS has remained elusive. Combined with the clinically meaningful slowing of disease progression, significant survival benefit, and consistent biomarker findings previously reported from PARADIGM, these results provide a compelling and highly differentiated body of evidence supporting PrimeC’s potential as a disease-modifying therapy. We believe this growing dataset further validates our scientific approach and positions PrimeC as one of the most comprehensively supported therapeutic candidates in ALS today.”

    “One of the central questions in ALS drug development is whether a therapy is truly affecting the underlying biology of the disease,” said Prof. Merit Cudkowicz, MD, MSc, Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, and Professor of Neurology at Harvard Medical School. “The TDP-43 findings reported in PARADIGM are particularly important because they suggest target engagement of a pathological process present in the majority of people with ALS. When viewed together with the previously reported safety, biomarker and clinical outcome data, and the high unmet need, these results provide compelling data supporting advancement into a confirmatory Phase 3 clinical trial.”

    “It is remarkable to see that the increase in NDE-associated TDP-43 observed in the placebo group follows the same trajectory as that identified in our longitudinal studies. This effect, together with the positive outcome of PARADIGM, highlights the promise of TDP-43 as a biomarker for monitoring treatment response,” said Dr. Erez Eitan, CEO of NeuroDex.

    Having secured FDA clearance to initiate its global Phase 3 (PARAGON) study, NeuroSense is advancing trial preparations while progressing regulatory interactions across multiple jurisdictions, including Canada.

    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 generated compelling clinical data from its Phase 2b PARADIGM study in ALS, demonstrating meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action. Notably, long-term follow-up data indicated a meaningful survival benefit, representing a potentially important advancement in the treatment of ALS.

    NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

    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.

    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.

    About ExoSORT and Neuron-derived EV

    ExoSORT™ is NeuroDex’s proprietary automated platform for the enrichment of neuron-derived extracellular vesicles (NDEs) from blood samples. Utilizing a combination of highly specific neuronal antibodies and a scalable 96-well workflow, ExoSORT™ selectively isolates extracellular vesicles originating from the brain, increasing the neuronal signal by more than 50-fold compared to conventional plasma analyses.

    By enriching for brain-derived vesicles, ExoSORT™ enables detection of disease-associated proteins present in multiple tissues, like TDP-43.

    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 potential of PrimeC. 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 outcomes and the timing of current and future clinical trials; the risk that 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

    SOURCE NeuroSense

    For further information: For further information: Email: [email protected] | Tel: +972 (0)9 799 6183

    Release – NeuroSense Announces Pricing of Insider-Led PIPE Financing

    Research News and Market Data on NRSN

    Financing led by CEO Alon Ben-Noon and CFO Or Eisenberg, alongside participation from an existing significant shareholder

    CAMBRIDGE, Mass., April 28, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the entry into a definitive agreement with certain investors to purchase $600,000 of ordinary shares in a private placement. In connection with the offering, NeuroSense agreed to sell an aggregate of 750,000 ordinary shares at a price of $0.80 per share, representing a purchase price of 6.7% above the closing pricing of NeuroSense’s ordinary shares on April 27, 2026.

    Continue Reading

    The private placement is subject to customary closing conditions and is expected to close during the week of May 3, 2026.

    The private placement included participation from Company insiders and a leading existing shareholder. Chief Executive Officer Alon Ben-Noon, Chief Financial Officer Or Eisenberg, and a significant existing investor each committed $200,000 in the offering.

    The Company intends to use the proceeds for general corporate purposes ahead of upcoming clinical and regulatory milestones.

    The offering is being made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the offering may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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 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 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, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding the offering, including as to the consummation of the offering described above, the expected gross proceeds from the offering, the intended use of proceeds and the timing of the receipt of proceeds of the offering, 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 outcomes and the timing of current and future clinical trials; 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 April 7, 2025 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

    For further information: For further information: Email: [email protected], Tel: +972 (0)9 799 6183

    Release – NeuroSense Granted Brazilian Patent Covering PrimeC Composition

    Research News and Market Data on NRSN

    • Patent Protection Through October 2042
    • Follows prior patent grants in the U.S. and Australia
    • Further strengthens NeuroSense’s global intellectual property portfolio

    CAMBRIDGE, Mass., April 6, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense” or the “Company”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Brazilian Patent and Trademark Office (INPI) has granted Brazilian Patent No. BR 112024007727-6, entitled “Compositions Comprising Ciprofloxacin and Celecoxib.”

    The granted Brazilian patent, following prior approval of the corresponding U.S. patent (12,097,185) and Australian patent (2022370513), provides protection for NeuroSense’s proprietary PrimeC composition in Brazil and extends patent coverage through October 2042, further strengthening the Company’s global intellectual property estate and supporting the long-term development and potential commercialization of PrimeC in ALS, Alzheimer’s disease and additional neurodegenerative indications.

    “This patent grant further reinforces the strength and durability of our intellectual property strategy around PrimeC,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “Securing composition-of-matter protection in Brazil is another important step in expanding our global IP footprint as we advance PrimeC toward pivotal development and potential commercialization.”

    PrimeC is a proprietary fixed-dose oral therapy combining ciprofloxacin and celecoxib in a synchronized, extended-release formulation specifically targeted to deliver both agents in a coordinated manner – a key differentiator versus simple co-administration. The formulation is designed to enable consistent exposure across multiple disease pathways implicated in ALS, including neuroinflammation, iron dysregulation, and miRNA dysregulation, supporting a multi-target disease-modifying approach.

    We are preparing for initiation of a Phase 3 pivotal clinical trial for PrimeC in ALS (PARAGON), following positive Phase 2b PARADIGM results and clearance from the FDA.

    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 LinkedIn, YouTube 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.

    About Alzheimer’s Disease
    Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.

    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 PrimeC pivotal trial. Further, certain forward-looking statements 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 risk that we do not complete in a timely fashion the PrimeC pivotal trial, and that the single pivotal trial will not be sufficient to support a New Drug Application submission; 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; the going concern reference in our financial statements and our need for substantial additional financing to achieve our goals; 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.

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    SOURCE NeuroSense

    For further information: For further information: [email protected], +972 (0)9 799 6183

    Release – NeuroSense Therapeutics Announces Receipt of Nasdaq Notifications Regarding Minimum Bid Price and Market Value Requirements

    Research News and Market Data on NRSN

    • Notifications have no immediate effect on the listing or trading of the Company’s securities on Nasdaq
    • Nasdaq has provided the Company until September 29, 2026 to regain compliance with both requirements
    • The Company is actively evaluating actions to regain compliance, with a clear focus on initiatives that are aligned with and supportive of long-term shareholder value

    CAMBRIDGE, Mass., April 3, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense” or the “Company”), a late-stage clinical biotechnology company developing treatments for severe neurodegenerative diseases, today announced that it received two notification letters from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) on April 2, 2026, indicating that the Company is not in compliance with certain continued listing requirements of The Nasdaq Capital Market.

    The first notification letter indicated that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share, since the closing bid price of the Company’s ordinary shares was below $1.00 per share for 30 consecutive business days, from February 18, 2026 through March 31, 2026.

    The second notification letter indicated that the Company is not in compliance with Nasdaq Listing Rule 5550(b)(2), which requires listed securities to maintain a minimum market value of listed securities (“MVLS”) of $35 million, since the Company’s MVLS was below $35 million for 30 consecutive business days over the same period.

    These notifications have no immediate effect on the listing or trading of the Company’s securities on Nasdaq. The Company’s ordinary shares and warrants will continue to trade on The Nasdaq Capital Market under the symbols “NRSN” and “NRSNW,” respectively.

    In accordance with Nasdaq Listing Rules, the Company has a compliance period of 180 calendar days, or until September 29, 2026, to regain compliance with both the minimum bid price requirement and the MVLS requirement. To regain compliance, the Company’s ordinary shares must maintain a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days, and the Company’s MVLS must close at $35 million or more for a minimum of 10 consecutive business days, in each case subject to Nasdaq’s discretion.

    The Company continues to actively monitor the closing bid price of its ordinary shares and its MVLS and is evaluating available actions to regain compliance with Nasdaq’s continued listing requirements, with a clear focus on initiatives that support and enhance long-term shareholder value. 

    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 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 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 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

    SOURCE NeuroSense

    For further information: For further information: [email protected], +972 (0)9 799 6183

    NeuroSense Therapeutics Ltd. (NRSN) – NeuroSense Reports FY2025 With Outlook For The Year


    Wednesday, April 01, 2026

    Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

    Refer to the full report for the price target, fundamental analysis, and rating.

    FY2025 Reported With PrimeC Progress Review. NeuroSense reported a loss for FY2025 of $11.1 million or $(0.44) per share. The company gave updates to its ongoing PrimeC development programs and expected milestones for the coming year in ALS and Alzheimer’s disease. As of December 31, 2025, NeuroSense had cash of approximately $0.2 million.

    Phase 3 In ALS Has Received FDA Clearance. During November 2025, NeuroSense received FDA clearance to initiate the Phase 3 trial in ALS. The company has completed commercial-scale manufacturing and continues to prepare for the Phase 3 trial, which we expect to begin later in FY2026.


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    This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

    *Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

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

    Research News and Market Data on NRSN

    • 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 [email protected].

    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 LinkedIn, YouTube 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.

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    SOURCE NeuroSense

    For further information: For further information: Email: [email protected] | Tel: +972 (0)9 799 6183

    View full release here.

    Release NeuroSense Advances Toward Key Regulatory Milestones with Strengthened Data Package and Near-Term Alzheimer’s Readout

    Research News and Market Data on NRSN

    CAMBRIDGE, Mass., March 24, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today provided an update on key regulatory and clinical milestones for its lead asset, PrimeC.

    Continue Reading

    Health Canada Pre-NDS Meeting

    A pre-New Drug Submission (pre-NDS) meeting with Health Canada has been rescheduled to May 2026.

    The decision was made to allow for the inclusion of additional emerging clinical, biomarker and survival data and analyses in the briefing package, which the Company believes will meaningfully strengthen the scientific and clinical foundation supporting PrimeC.

    The Company remains focused on advancing PrimeC under the NOC/c pathway in Canada, which is designed to facilitate earlier access to promising therapies addressing serious unmet medical needs.

    Alzheimer’s Disease Program Update

    The Company expects to report clinical and biomarker results from its Alzheimer’s study in the coming weeks.

    Continued Momentum Across Key Programs

    NeuroSense continues to advance its clinical and regulatory strategy for PrimeC, supported by our previously disclosed:

    • Statistically significant survival benefit (65% reduction in risk of death)
    • Expanding biomarker dataset supporting multi-mechanistic activity
    • FDA clearance to initiate the pivotal Phase 3 PARAGON trial in ALS

    “As we generated additional valuable data, we believe it is strategic to incorporate these findings and analyses into our regulatory interactions,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “Our objective is to present the most comprehensive and robust dataset possible to Health Canada, thereby maximizing the likelihood of a constructive and efficient regulatory pathway. We believe this approach positions the Company ahead of several important value inflection points across its ALS and Alzheimer’s programs expected in 2026.”

    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 LinkedIn, YouTube 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 April 7, 2025 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

    SOURCE NeuroSense

    For further information: For further information: [email protected], +972 (0)9 799 6183

    Release – PrimeC New Data to Be Presented at AD/PD™ 2026 Conference

    Research News and Market Data on NRSN

    Dr. Christian Lunetta to Present “From PARADIGM to PARAGON: Advancing PrimeC for ALS through Phase 2 Clinical and Biomarker Insights toward a Global Phase 3 Trial”

    CAMBRIDGE, Mass., March 18, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that Dr. Christian Lunetta will present new data and insights on the development of PrimeC, the company’s investigational therapy for amyotrophic lateral sclerosis (ALS), at the AD/PD™ 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, to be held in Copenhagen, Denmark, on March 19, 2026.

    Dr. Lunetta’s presentation, titled “From PARADIGM to PARAGON: Advancing PrimeC for ALS through Phase 2 Clinical and Biomarker Insights toward a Global Phase 3 Trial,” will take place during the symposium “Mechanisms and Therapeutics in the ALS-FTD Spectrum (SOD-1, TDP-43, C9ORF72 and TMEM106B).”

    The presentation will review key clinical and biomarker findings from the Phase 2b PARADIGM trial, which evaluated PrimeC in people living with ALS. The data provide important insights into disease mechanisms and treatment effects that helped inform the design of the company’s global Phase 3 PARAGON trial, currently being advanced to further evaluate PrimeC’s safety and efficacy.

    “ALS is one of the most complex neurodegenerative diseases, and advancing therapeutic development requires the integration of rigorous clinical research with deeper biological insight,” said Dr. Christian Lunetta. “The clinical findings emerging from the PARADIGM trial, together with the expanding biomarker analyses, provide an important scientific foundation as we advance toward the PARAGON Phase 3 study. I look forward to sharing these results with the scientific community at AD/PD 2026 and to contributing, together with fellow investigators, to the next stage of clinical development as we work to advance meaningful therapeutic options for people living with ALS.”

    “We are deeply appreciative of Dr. Lunetta’s role in presenting these findings and of his contribution as part of the clinical investigator community behind this work,” said Dr. Shiran Zimri, NeuroSense VP of Research and Development and Canada Country Lead. “The timing of this presentation, coming just days after the publication of the PARADIGM results in JAMA Neurology and at such a highly regarded scientific forum, is especially meaningful. It creates a unique moment where robust, peer-reviewed data can immediately be brought into scientific exchange and critical discussion. For us, this is not only about sharing results, but about engaging the field in a deeper understanding of the clinical and biomarker insights from PARADIGM as we advance with urgency toward our global Phase 3 PARAGON study.”

    The PARAGON Phase 3 trial is planned as a multinational, randomized, double-blind, placebo-controlled study designed to further evaluate PrimeC’s potential to slow disease progression in people living with ALS.

    NeuroSense continues active engagement with regulatory authorities to advance PrimeC toward potential marketing authorization.

    About NeuroSense

    NeuroSense Therapeutics 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 LinkedIn, YouTube 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, 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 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 April 7, 2025 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

    SOURCE NeuroSense

    For further information: For further information: Email: [email protected] | Tel: +972 (0)9 799 6183