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]

Core Insights - NeuroSense Therapeutics Ltd. has scaled up the production of its lead drug candidate, PrimeC, to a commercial scale, which is an extended-release oral formulation combining ciprofloxacin and celecoxib for treating amyotrophic lateral sclerosis (ALS) [1][2] - The company has enhanced its supply chain through comprehensive Chemistry, Manufacturing, and Controls (CMC) improvements and has partnered with a global contract development and manufacturing organization (CDMO) for future commercial supply [2][3] - Stability data indicates a shelf life of at least 36 months at room temperature, and the formulation's intellectual property protection extends until 2042 [3] Commercial Potential - Forecasts suggest that PrimeC could achieve peak annual revenues of $100–150 million in Canada [4] - D. Boral Capital has initiated coverage on NeuroSense with a Buy rating and a price target of $14, citing strong mechanistic rationale supported by preclinical and translational research [4] - The ongoing Phase 2b PARADIGM trial is expected to provide further validation, with topline results anticipated in the second half of 2025 [4] Clinical Developments - Recent findings from the Phase 2b PARADIGM clinical trial indicate that PrimeC significantly impacts microRNA modulation, which is crucial for understanding its potential to slow ALS progression [5][6] - The treatment has shown a 33% reduction in disease progression and a 58% improvement in survival rates [6] Expansion and Strategic Partnerships - NeuroSense is exploring expansion into Alzheimer's and Parkinson's diseases, utilizing similar pathophysiologic targets with modified drug combinations, which could broaden its market reach [7] - The company is in advanced discussions with several multi-billion-dollar pharmaceutical companies for a potential strategic partnership to develop and commercialize PrimeC for ALS [8] - The stock price of NeuroSense has increased by 6.34%, reaching $1.11 [8]

NeuroSense Announces Global CDMO Selection and Manufacturing Scale-Up, Enabling Rapid Pathway to Commercialization for What is Projected to be a $100-150M Canadian Market OpportunityCAMBRIDGE, Mass., May 7, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that it has successfully scaled-up its production of PrimeC to commercial scale, marking a signif ...

Letter outlines Phase 3 timeline for PrimeC in ALS, provides update on Canadian regulatory pathway and strategic partnership discussions; Company optimistic about ongoing partnership discussions with global pharmaceutical companyCAMBRIDGE, Mass., April 24, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today issued a shareholder letter from Chief Executive Officer ...

New miRNA findings unveiled at the AAN, reveal key biological mechanisms behind PrimeC's clinical benefit in ALS.CAMBRIDGE, Mass., April 9, 2025 /PRNewswire/ -- NeuroSense Therapeutics, Ltd. (NASDAQ: NRSN), a leading clinical-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, today announced promising new findings from its Phase 2b PARADIGM clinical trial. The data highlights the significant impact of PrimeC, the company's investigational therapy for the trea ...