NeuroSense Provides Business Update and Progress for the First Half of 2026

Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense" or the "Company"), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today provided a business update with corporate highlights to date and financial results for the first half of 2026.

NeuroSense is advancing PrimeC, its investigational combination therapy for amyotrophic lateral sclerosis (ALS), through regulatory pathways in the United States and Canada while pursuing a focused, capital-efficient late-stage development strategy.

Upcoming Corporate Highlights for the Remainder of 2026 include:

Targeting December 2026 NDS filing in Canada – Following completion of the Pre-New Drug Submission process and finalization of meeting minutes with Health Canada, NeuroSense is preparing an NDS for PrimeC in ALS and is targeting December 2026 for submission. Health Canada indicated no concerns with the proposed filing timeline and provided alignment regarding the planned content and structure of the submission.

Advancing an optimized, capital-efficient U.S. development strategy – NeuroSense is working toward an optimized path for PrimeC that includes AI-enabled characterization of PrimeC's proprietary formulation, a planned active-comparator study against edaravone, and evaluation of a smaller and shorter pivotal PARAGON design. The Company plans to discuss with the FDA whether the existing data may support full approval or, alternatively, an Accelerated Approval pathway. Any revised pivotal design or regulatory pathway remains subject to FDA alignment.

Continued financing and strategic initiatives – The Company continues to pursue financing opportunities, including potential non-dilutive funding sources, and evaluate a range of strategic alternatives, including potential business and corporate transactions, intended to provide the resources and strategic framework required to advance PrimeC, while prioritizing capital-efficient development and preserving long-term shareholder value.

2026 Corporate Highlights to Date

PARADIGM results published in JAMA Neurology and long-term survival benefit strengthened – In March 2026, results from the Phase 2b PARADIGM study were published in JAMA Neurology, providing peer-reviewed validation of PrimeC's clinical and biological activity. Long-term follow-up reported in February 2026 showed a statistically significant 65% reduction in the risk of death and an estimated median survival of 36.3 months for participants treated continuously with PrimeC, compared with 21.4 months for participants initially assigned to placebo before crossing over to PrimeC.

Primary endpoint achieved – In June 2026, NeuroSense announced that PARADIGM achieved its primary endpoint, demonstrating a statistically significant treatment-associated reduction in extracellular vesicle-associated TDP-43 compared with placebo. TDP-43 pathology is present in more than 97% of ALS cases, and the finding adds to the consistent body of evidence observed across clinical outcomes, survival and multiple disease-relevant biomarkers.

Canadian regulatory pathway advanced toward NDS filing – NeuroSense held a constructive Pre-NDS me...