NeuroSense to Present Integrated Clinical and Biomarker Evidence Shaping PrimeC's Phase 3 Development at NEALS 2026

(NASDAQ:NRSN) NeuroSense Therapeutics Ltd. announced that its clinical and biomarker findings from the PARADIGM program, which are informing the next phase of PrimeC's development, will be presented at the 2026 Annual Meeting of the Northeast Amyotrophic Lateral Sclerosis (NEALS) Consortium in Clearwater, Florida. The presentation, titled "From PARADIGM to PARAGON: Converging Clinical and Biomarker Findings Informing Phase 3 Development of PrimeC," is scheduled for Friday, October 30, at 11:25 a.m. Eastern Time. The presentation will highlight how findings from the PARADIGM Phase 2b program are shaping the design of PARAGON, NeuroSense's planned Phase 3 study of PrimeC in ALS, aiming for a more rigorous and efficient clinical development approach. The presentation will be co-presented by Prof. Merit Cudkowicz, MD, MSc, Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and Julieanne Dorn Professor of Neurology at Harvard Medical School, and Dr. Shiran Zimri, PhD, Vice President of R&D and Country Lead, Canada, at NeuroSense. NeuroSense's lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression in ALS, including neuroinflammation, oxidative stress, and dysregulated iron metabolism. NeuroSense has 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 compared to 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, which will be conducted primarily in the United States. The company is working with the FDA on an optimized design for the study. PrimeC 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 RNA regulation, with the potential to inhibit disease progression. Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes progressive paralysis and, typically, death within 3 years of symptom 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.

NeuroSense Completes PrimeC Pre-NDS Process and Advances Toward December 2026 Filing with Health Canada

(NASDAQ: NRSN) NeuroSense Therapeutics Ltd. announced that it is targeting December 2026 for the filing of a New Drug Submission ("NDS") with Health Canada for PrimeC, its lead therapeutic candidate for amyotrophic lateral sclerosis ("ALS"). The filing target follows the successful finalization of the Pre-NDS process with Health Canada and the associated meeting minutes. Health Canada has indicated that it has no concerns with the Company's proposed filing timeline and advised the Company to target early December. Health Canada's target review timeline for a standard NDS is approximately 300 days following acceptance for review. The planned NDS will be supported by evidence from NeuroSense's Phase 2b PARADIGM clinical program, including achievement of the study's prespecified primary TDP-43 biomarker endpoint and a statistically significant ~15-month median survival benefit (HR 0.35, p=0.0037). Based on publicly reported Canadian data, over 3,000 Canadians are currently living with ALS, and approximately 1,000 Canadians are diagnosed with the disease each year. Oral edaravone carries an estimated annual drug-acquisition cost of approximately C$120,000 (approximately US$85,000) per patient.

NeuroSense to Participate in Roth-Hosted KOL Webinar on the Future of ALS Treatment: "A Quest to Outrun ALS"

(NASDAQ: NRSN) NeuroSense Therapeutics Ltd. announced its participation in a key opinion leader (KOL) webinar hosted by Roth Capital Partners titled "A Quest to Outrun Amyotrophic Lateral Sclerosis (ALS)." The live webinar will take place on Wednesday, July 8, 2026, at 11:00 a.m. Eastern Time and will feature Professor Jeremy Shefner, M.D., Ph.D., Chair of Neurology at Barrow Neurological Institute and Co-Founder of the Northeast ALS Consortium (NEALS), and Alon Ben-Noon, Chief Executive Officer of NeuroSense. NeuroSense'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 and significant biological activity across multiple biomarkers associated with ALS, including microRNAs. Long-term follow-up data indicated a meaningful survival benefit for PrimeC. 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. The company projects that the number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

NeuroSense Therapeutics Receives Japanese Patent Grant for PrimeC Novel Composition

(NASDAQ:NRSN) NeuroSense Therapeutics Ltd. announced that the Japan Patent Office has issued Japanese Patent 7857044 covering the Company's lead drug candidate for the treatment of amyotrophic lateral sclerosis (ALS), providing protection through 2042. The patent includes 17 claims and covers the unique formulation and manufacturing process of PrimeC, including its synchronized delivery profile of celecoxib and ciprofloxacin. PrimeC has demonstrated consistent clinical, biomarker, and survival benefit in the Phase 2b PARADIGM study, including a significant survival benefit in extended follow-up analyses. NeuroSense has received FDA's clearance to proceed and is preparing for initiation of a Phase 3 pivotal study (PARAGON), which is expected to enroll approximately 300 participants, primarily in the United States. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU. 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 Japanese patent is expected to provide long-term protection for PrimeC's proprietary formulation in a key strategic market, subject to standard terms and potential extensions.

NeuroSense Announces Pricing of Insider-Led PIPE Financing

NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) announced a definitive agreement with certain investors to purchase $600,000 of ordinary shares in a private placement. The company will sell an aggregate of 750,000 ordinary shares at a price of $0.80 per share, which is 6.7% above the closing price on April 27, 2026. The financing is led by CEO Alon Ben-Noon and CFO Or Eisenberg, with participation from a significant existing shareholder, and is expected to close during the week of May 3, 2026. Each of the CEO, CFO, and a significant existing investor committed $200,000 in the offering. Proceeds are intended for general corporate purposes ahead of upcoming clinical and regulatory milestones.