
Core Insights - NeuroSense Therapeutics is advancing its investigational therapy PrimeC for ALS and preparing for a pivotal Phase 3 trial [2][3] - The first half of 2025 has been transformational for the company, regaining Nasdaq compliance and generating additional long-term data from its Phase 2b study [3][5] Corporate Highlights for H1 2025 - Nasdaq compliance was restored after a $5 million private placement in December 2024, strengthening the balance sheet [5] - New analyses from the Phase 2b PARADIGM study showed PrimeC slowed functional decline by approximately 40%, improved overall survival by 74%, and complication-free survival by 79% [6] - Manufacturing capabilities for PrimeC were successfully scaled to commercial levels, ensuring supply chain readiness [8] Financial Results for H1 2025 - Research and development expenses decreased by 32.9% to $2,503 thousand compared to $3,733 thousand in the same period of 2024 [12] - General and administrative expenses slightly decreased by 4.4% to $2,189 thousand [12] - The net loss for the first half of 2025 was $4,709 thousand, down from $6,261 thousand in the first half of 2024 [12] Future Plans - NeuroSense plans to submit a new request for Notice of Compliance with conditions (NOC/c) in Canada, supported by additional data [11] - A multinational Phase 3 study of PrimeC is expected to commence in the second half of 2025 following positive regulatory feedback from the FDA [11] - Discussions are ongoing with a global pharmaceutical partner to advance the development and commercialization of PrimeC [11]