Talphera Hits Midpoint in CRRT Study, Raises $4.1M as Enrollment Accelerates — Talphera, Inc.

Event summary

Talphera reached 50% enrollment (35/70 patients) in its NEPHRO CRRT clinical study, with all 12 sites now active.
Closed $4.1M third tranche of private placement financing upon hitting enrollment milestone.
Cash and investments stood at $20.4M as of December 31, 2025.
2026 guidance projects $17M–$18M in operating expenses, up from $13M in 2025, driven by CRRT study costs.

The big picture

Talphera's progress in the NEPHRO CRRT study positions it to address a critical unmet need in anticoagulation for renal replacement therapy. The Breakthrough Device Designation could expedite regulatory review, but the company faces execution risks as it scales enrollment and prepares for a potential PMA filing. With $20.4M in cash, Talphera has runway to advance its lead candidate, though rising expenses signal the need for additional financing in 2026.

What we're watching

Clinical Execution: Whether Talphera can maintain accelerated enrollment pace to complete the study by year-end 2026.
Regulatory Pathway: How the Breakthrough Device Designation will influence FDA review timelines for Niyad.
Financial Runway: The pace at which Talphera burns through its $20.4M cash position amid rising R&D and SG&A expenses.