Enrollment Progress & Milestones
Achieved the 50% enrollment milestone in early March 2026 and have since "well exceeded" 50%; company expects to complete enrollment in 2026 and to file a PMA for Niyad in 2027. 9 of 12 activated sites aligned with the new target profile and have enrolled over 90% of patients to date.
Site Quality, KOL and Investigator Support
Nephrologist-led sites and principal investigators are highly engaged; KOLs endorsed nafamostat as addressing an unmet need based on ~4 decades of use outside the U.S.; clinical staff reported strong enthusiasm and operational support for the NEPHRO study.
Operational & Clinical Performance (Dosing Stability)
Study design enables rapid data: primary endpoint at 24 hours and secondary at 72 hours. Bedside ACT monitoring showed ~70% of cases reach target ACT at the first starting dose, ~25% require one titration, and by the end of the first hour nearly all patients are in range — indicating dosing stability and simplicity of administration.
Cash Position and Financing Activity
Cash balance of $21.1M as of March 31, 2026; closed a $4.1M tranche in the quarter. Two remaining conditional financing tranches totaling approximately $16M are expected to close around the topline data/study completion, and management believes cash plus those tranches should provide sufficient capital through a potential Niyad PMA approval.
Fast Data Readout Expectation
Management expects to announce Last Patient Out (LPO) and then deliver top-line data within roughly one month after LPO due to the short (24/72 hour) endpoints; guidance remains for a top-line read in the second half of 2026.