Talphera (TLPH) Q3 2026 earnings summary

Executive summary

• NEPHRO-CRRT enrollment exceeded 75% of its 70-patient target, with estimated power above 80% for the primary endpoint; FDA is reviewing a request to close enrollment by Dec. 31, 2026.

• Updated research estimates peak annual U.S. Niyad sales for CRRT at more than $200 million, contingent on approval.

Financial highlights

• Q3 revenue was $1K versus $28K in Q3 2025; operating expenses were $4.136M versus $3.423M, and operating loss was $4.1M versus $3.4M.

• Q3 net loss was $4.018M versus $4.436M; nine-month net loss was $10.886M versus $10.518M.

• Q3 R&D and SG&A excluding non-cash stock compensation were $3.844M versus $3.271M; nine-month totals were $11.259M versus $9.545M.

• Cash, cash equivalents and short-term investments were $14.157M at Sept. 30, 2026, versus $20.381M at Dec. 31, 2025.

• Nine-month cash used in operations was $10.4M versus $8.9M.

Outlook and guidance

• The FDA briefing document seeks agreement to close enrollment as of Dec. 31, 2026, potentially below 70 patients; feedback is expected before year-end.

• Top-line data are expected 4–6 weeks after enrollment closes; potential Niyad PMA approval is expected in 2027.

• If FDA does not agree to early closure, enrollment would continue toward 70 patients, with internal forecasts placing completion in Q1 2027.

• A possible FDA middle path could allow PMA filing while the study remains open to collect supplemental data.