Core Insights - The FDA has approved a reduction in the NEPHRO CRRT study patient count from 166 to 70, which is expected to enhance the study's execution momentum [2][6] - Talphera anticipates completing the NEPHRO CRRT study by the end of 2025, supported by new site additions and financing [2][6] - The company reported a net loss of 4.5 million in Q4 2023 [4][17] Financial Highlights - As of December 31, 2024, Talphera had cash and investments totaling 14.8 million announced [6][19] - Combined R&D and SG&A expenses for Q4 2024 were 4.6 million in Q4 2023, primarily due to reduced personnel and administrative costs [4][20] - The net loss attributable to common shareholders for Q4 2024 was 0.07 per share, compared to a net loss of 0.25 per share, in Q4 2023 [4][17] Study and Product Development - The NEPHRO CRRT study is designed to evaluate the efficacy of Niyad in patients undergoing renal replacement therapy who cannot tolerate heparin [13] - The primary endpoint of the study is the mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours [13] - Niyad has received Breakthrough Device Designation from the FDA, indicating its potential to address significant unmet needs in the CRRT market [10][12]
Talphera Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update