NeuroSense Adds New Data To PrimeC Application, Delays Health Canada Filing To March 2027

Expanded package to include new neurofilament light chain (NfL) analysis; Health Canada confirms March 2027 filing timeline

Submission would be PrimeC's first marketing application in any jurisdiction, potentially addressing approximately 4,000 Canadians living with ALS

CAMBRIDGE, Mass., Nov. 2, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense" or the "Company"), a late-stage clinical biotechnology company developing treatments for neurodegenerative diseases, today announced plans to incorporate newly generated data into its New Drug Submission (NDS) to Health Canada for PrimeC, its lead investigational therapy for amyotrophic lateral sclerosis (ALS). The NDS would be PrimeC's first marketing application in any jurisdiction, and the Company believes the additional data will strengthen the application and expand the evidence available for regulatory review.

The March 2027 filing target updates the previously announced December 2026 timetable, allowing the additional data to be included. Health Canada has confirmed it has no concerns with the revised timing.

The planned filing follows completion of the pre-submission process and alignment with Health Canada on the proposed submission content and structure. The expanded package will combine the Phase 2b PARADIGM results published in JAMA Neurology with a new neurofilament light chain (NfL) analysis and additional unpublished data from the Phase 2b PARADIGM trial. The Company expects the NfL analysis to provide further biomarker evidence supporting the clinical findings observed in PARADIGM. In the new analysis, PrimeC-treated participants demonstrated a greater reduction in NfL compared to placebo, with an even more pronounced effect observed in participants with higher baseline functionality. Additional statistical analyses are underway to further characterize these findings and support their incorporation into the planned submission to Health Canada.

Following acceptance of the NDS for review, Health Canada's standard review target for an NDS is approximately 300 calendar days. If approved, PrimeC would receive its first regulatory authorization and would address a population of approximately 4,000 Canadians living with ALS, with approximately 1,000 new diagnoses each year. In parallel, the Company is advancing discussions with potential commercialization partners for Canada.