PR Newswire·Nov 12, 2026, 4:01 PM ET

Talphera Reports Third Quarter 2026 Financial Results and Provides Business Update

Talphera submitted an FDA briefing document to request closure of the NEPHRO CRRT study enrollment as of December 31, 2026, even if fewer than the targeted 70 patients are enrolled.
The current enrollment exceeds 80% statistical power for the primary endpoint, supporting a potential early close of the study.
Updated market research raised the peak sales estimate for nafamostat in CRRT to above $200 million.
Cash and investments totaled $14.2 million as of September 30, 2026.
Combined R&D & SG&A expenses for Q3 2026 were $4.1 million, with a net loss attributable to common shareholders of $4.0 million ($0.05 per share).
Talphera plans to file a Form S-3 Shelf Registration Statement to replace its existing form expiring on November 30, 2026.
A conference call & webcast regarding these results was held on November 12, 2026, at 4:30 p.m. ET.
Enrollment challenges in the NEPHRO study are attributed to fewer qualifying critically ill patients at clinical sites.
Niyad is a lyophilized formulation of nafamostat currently under an IDE with Breakthrough Device Designation status from the FDA.