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, with all 12 clinical sites now enrolling and study completion expected in 2026.

• Cash and investments as of December 31st were $20.4M, with additional tranches expected to fund operations through potential FDA approval of Niyad.

• Key opinion leaders highlighted significant unmet needs in CRRT anticoagulation, with current options (heparin, citrate) presenting efficacy, safety, and operational challenges.

• Niyad (nafamostat) is viewed as a promising, simpler, and potentially safer alternative, with strong enthusiasm from clinical staff and expectations for rapid adoption if approved.

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

Financial highlights

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

• Cash and investments totaled $20.4M at year-end 2025, up from $8.9M at year-end 2024.

• Combined R&D and SG&A expenses for Q4 2025 were $3.5M, up from $3.0M in Q4 2024; full-year 2025 expenses were $13.5M, down from $15.3M in 2024.

• Net loss for Q4 2025 was $3.8M ($0.06 per share), compared to $1.9M ($0.07 per share) in Q4 2024; full-year net loss was $14.3M ($0.34 per share) versus $13.0M ($0.50 per share) in 2024.

• 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 top-line data and PMA submission anticipated in 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 expects to maintain adequate funding for operations through approval, with no anticipated capital shortfall.

• Market exclusivity in the U.S. is projected for at least six years post-approval, with additional patent protection potentially extending into the 2040s.