NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a late-stage clinical biotechnology company focused on developing treatments for severe neurodegenerative diseases, has provided a business and financial update for the first half of 2025, highlighting advances in its ALS program and corporate developments.
The company continues to progress its lead investigational therapy, PrimeC, a combination treatment for amyotrophic lateral sclerosis (ALS), as it moves toward a pivotal Phase 3 trial. According to CEO Alon Ben-Noon, NeuroSense has strengthened its regulatory strategy, advanced manufacturing capabilities, and generated new long-term data from its Phase 2b PARADIGM study, all supporting the next stage of clinical development.
Key Updates:
- Regulatory Path Forward: NeuroSense plans to resubmit a Notice of Compliance with conditions (NOC/c) request to Health Canada later this year with additional supporting data, while preparing for a multinational Phase 3 ALS study following favorable FDA feedback.
- Potential Strategic Partnership: The company continues discussions with a global pharmaceutical partner under a previously signed binding term sheet for PrimeC’s development and commercialization in select markets.
- New Clinical Data: Updated analyses from the Phase 2b study showed PrimeC slowed functional decline by approximately 40%, improved overall survival by 74%, and enhanced complication-free survival by 79% in per-protocol participants. Biomarker data indicated strong multi-target engagement supporting its disease-modifying potential.
- Manufacturing Scale-Up: NeuroSense successfully scaled PrimeC production to commercial levels, secured a global manufacturing partner, and demonstrated a 36-month shelf life, ensuring future supply chain readiness.
- Nasdaq Compliance Restored: In January 2025, the company regained compliance with Nasdaq’s equity requirements after completing a $5 million private placement in late 2024.
Financial Results:
For the six months ended June 30, 2025, research and development expenses totaled $2.5 million, down 33% from $3.7 million in the same period of 2024 due to lower clinical activity. General and administrative expenses were $2.2 million, a slight decrease from $2.3 million last year. Total operating expenses were $4.7 million compared to $6 million in the prior-year period.
Looking ahead to the second half of 2025, NeuroSense plans to initiate its Phase 3 trial, advance regulatory submissions, and potentially finalize a strategic partnership to accelerate PrimeC’s path to market for ALS patients.
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