Summary by Futu AI
NeuroSense Therapeutics, a clinical-stage biotechnology company, has reported significant progress in its clinical trials and development programs for its lead product candidate, PrimeC, aimed at treating neurodegenerative diseases such as ALS. The company filed a Form 6-K with the SEC for September 2024, which included condensed interim unaudited financial statements and a summary of its operating and financial review as of June 30, 2024. NeuroSense completed the primary safety and tolerability endpoints of its Phase IIb PARADIGM study and observed positive clinical efficacy in slowing disease progression. The company plans to meet with the FDA and EMA in Q4 2024 and commence a pivotal clinical trial for PrimeC in H1 2025. NeuroSense also completed a long-term toxicity study supporting the long-term use of PrimeC. Financially, NeuroSense incurred net losses of $6.26 million for the six months ended June 30, 2024, and had an accumulated deficit of $32.38 million. The company's existing cash is expected to fund operations into Q4 2024, with future funding requirements dependent on various factors including clinical trial progress and regulatory approvals.