NeuroSense Reports 74% ALS Survival Improvement with PrimeC, Preps Phase 3 Trial and Faces Financial Challenges

NeuroSense Therapeutics reports a 74% improvement in ALS patient survival with its PrimeC treatment in Phase 2b trials. The company is preparing for a pivotal Phase 3 trial in H2 2025 and has regained Nasdaq compliance through a $5 million private placement. However, financial challenges persist with a cash reserve drop to $666,000 by mid-2025.

NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a leading clinical biotechnology company focused on developing novel treatments for severe neurodegenerative diseases, has announced significant progress in its Phase 2b trials for PrimeC, an investigational combination therapy for amyotrophic lateral sclerosis (ALS). The company reported a 74% improvement in ALS patient survival in the per-protocol population of the Phase 2b PARADIGM study, which included 68 participants living with ALS in Canada, Italy, and Israel [1].

The PARADIGM study, a prospective, multinational, randomized, double-blind, placebo-controlled trial, showed that treatment with PrimeC slowed functional decline by approximately 40%, improved overall survival by 74%, and enhanced complication-free survival by 79% compared to placebo. Additionally, patients experienced a 26% slower decline in slow vital capacity, indicating PrimeC's potential as a disease-modifying therapy [1].

NeuroSense is now preparing for a pivotal Phase 3 trial in the second half of 2025, following positive regulatory feedback from the FDA. The company aims to begin a multinational Phase 3 study of PrimeC in ALS, which is expected to further validate the drug's efficacy and safety [1].

In addition to its clinical advancements, NeuroSense has regained compliance with Nasdaq's stockholders' equity requirement through a $5 million private placement in December 2024. The financing strengthened the company's balance sheet and raised shareholders' equity above Nasdaq's minimum requirement [1].

However, financial challenges persist for NeuroSense, with a cash reserve drop to $666,000 by mid-2025. The company's research and development expenses for the six months ended June 30, 2025, amounted to $2,503 thousand, a decrease of $1,230 thousand or 32.9% compared to the same period in 2024. General and administrative expenses also decreased by $102 thousand, or 4.4%, but operating expenses remained high at $4.7 million [1].

References:
[1] https://www.prnewswire.com/il/news-releases/neurosense-provides-business-update-and-progress-for-the-first-half-of-2025-302518725.html