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...

The Journal of the American Medical Association (JAMA Neurology) publication highlights consistent clinical and biomarker findings from NeuroSense PARADIGM Phase 2b trial in ALS, including slower functional decline, reduced risk of ALS-related complications, and modulation of disease-relevant biomarkers CAMBRIDGE, Mass., March 16, 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 results from the Phase 2b clinical trial (PARADIGM) evaluating PrimeC in people living with amyotrophic lateral sclerosis (ALS) have been published in JAMA Neurology. Earlier today, Mass General Brigham (MGB) and Barrow Neurological Institute (BNI) issued a joint announcement highlighting the publication and the contributions of the investigators involved in the PARADIGM trial. NeuroSense is honored to collaborate with these leading ALS research centers of excellence and their distinguished clinical teams in advancing research for people living with ALS. PARADIGM was a randomized, double-blind, placebo-controlled trial that evaluated the safety, biological activity, and potential clinical effects of PrimeC during a 6-month blinded treatment period followed by a 12-month open-label extension. PrimeC is a novel fixed-dose oral combination formulated in a synchronized extended-release composition designed to concurrently address three key mechanisms implicated in ALS progression: neuroinflammation, iron dysregulation, and microRNA-mediated regulatory pathways. The publication was authored by a distinguished international group of ALS investigators, including Merit Cudkowicz, MD, MSc (Mass General Brigham and Harvard Medical School), Vivian Drory, MD (Tel-Aviv Sourasky Medical Centre), Adriano Chiò, MD, PhD (University of Torino), Christian Lunetta, MD (IRCCS Maugeri), Christen Shoesmith, MD (London Health Sciences Centre), Ruben van Eijk, MD, PhD (UMC Utrecht), Jeffrey Rosenfeld, MD, PhD (Loma Linda University), and Jeremy Shefner, MD, PhD (Barrow Neurological Institute), together with additional collaborators across North America, Europe, and Israel. Key highlights from the PARADIGM phase 2b study published Strong safety and tolerability profile: PrimeC demonstrated a safety profile comparable to placebo over...

Phase 2b study completed in amyotrophic lateral sclerosis (ALS) demonstrated lead asset PrimeC slows disease progression and functional decline Ongoing partnership discussions to advance PrimeC to Phase 3 study in ALS and commercialization Phase 3 study design for PrimeC in ALS aligned with FDA; planned initiation in 2025 CAMBRIDGE, Mass., April 7, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a clinical-stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reports its financial results for the year ended December 31, 2024 and provides a business update. Business highlights from 2024 and to date PrimeC achieved primary and secondary clinical endpoints in PARADIGM Phase 2b study investigating PrimeC in ALS (n=68) with data showing the following: - PrimeC slowed disease progression (measured by ALSFRS-R) by approximately 33% after 18 months (p=0.007) - PrimeC reduced likelihood of mortality, hospitalization and respiratory support, resulting in an overall 58% improvement in survival rates. - PrimeC slowed functional decline, especially speaking and swallowing functions. - PrimeC demonstrated favorable safety and tolerability profile, achieving the study's primary endpoint. Phase 3 study design for PrimeC for ALS aligned with FDA following Type C meeting. Partnership discussions are continuing in order to advance PrimeC towards regulatory approval and eventual commercialization. Plans to file for early commercialization for PrimeC in Canada, with an estimated potential market opportunity of $100m-$150m in peak annual revenues. Key patent granted by U.S. Patent and Trademark Office (USPTO), extending the patent protection for the novel formulation of PrimeC until 2042. "2024 was a year of significant clinical progress for NeuroSense," stated NeuroSense CEO, Alon Ben-Noon. "We successfully completed our Phase 2b study for PrimeC in ALS, with data showing transformative results in a neurodegenerative indication of immense medical need. The results conclude with PrimeC's disease-modifying potential and strongly support advancing PrimeC towards a Phase 3 study. With positive FDA feedback on the proposed study design, we are putting everything in place for the next stage of NeuroSense's growth, driven by PrimeC's continued clinical development." Financial Results Research and developmen...