Talphera (TLPH) Q4 2025 & Investor Day earnings summary

Executive summary

• The Nephro CRRT registrational study reached 50% enrollment (35 of 70 patients), triggering a $4.1M financing tranche and progressing toward FDA approval for Niyad, a potential new anticoagulant for CRRT circuits, with all 12 clinical sites now enrolling and study completion expected in 2026.

• Current anticoagulation options for CRRT, mainly heparin and citrate, are seen as inadequate due to efficacy, safety, and operational complexity, and experts anticipate that nafamostat (Niyad) could address unmet needs by offering a simpler, safer, and more effective solution for critically ill ICU patients.

• Hosted a virtual investor and analyst day to provide business updates and clinical insights from principal investigators.

Financial highlights

• As of December 31, cash and investments totaled $20.4M, up from $8.9M at year-end 2024, with additional tranches expected to fund operations through potential FDA approval.

• Gross proceeds of $4.1M were received upon reaching the 50% enrollment milestone in the Nephro CRRT study.

• Combined R&D and SG&A expenses for Q4 2025 were $3.5M, with full-year 2025 expenses at $13.5M, down from $15.3M in 2024.

• Net loss for Q4 2025 was $3.8M ($0.06 per share), with a full-year net loss of $14.3M ($0.34 per share).

• Non-cash stock-based compensation for Q4 2025 was $185,000; for the year, $699,000.

Outlook and guidance

• Enrollment for the NEPHRO CRRT study is expected to complete in the first half of 2026, with a PMA submission planned for the second half of 2026.

• 2026 cash operating expenses (excluding stock-based compensation) expected to be $17–18M, up from $13M in 2025, driven by study and CMC expenses.

• The company anticipates sufficient cash runway to support operations through FDA approval, assuming remaining tranches are closed.