Savara (SVRA) Q3 2026 earnings summary

Executive summary

• MOLBREEVI, the sole program, is under regulatory review in the U.S., EU and U.K. for autoimmune PAP; Q3 net loss widened to $43.0M from $29.6M YoY.

• FDA Priority Review has a November 22, 2026 target action date following a three-month extension; the BLA was filed in February 2026.

Financial highlights

• Q3 2026 operating expenses were $43.5M, up from $30.3M YoY; operating loss was $43.5M and net loss was $43.0M.

• Q3 R&D was $24.9M versus $20.6M YoY; G&A was $18.5M versus $9.6M, driven largely by stock compensation, hiring and launch preparation.

• 9M 2026 operating expenses were $123.5M versus $90.1M; net loss was $120.5M versus $86.6M.

• 9M operating cash use was $105.3M; investing activities provided $102.4M, primarily from short-term investment maturities and transactions.

Outlook and guidance

• Current operating plan projects cash and short-term investments will fund operations for at least 12 months from issuance of the financial statements.

• R&D spend is expected to remain significant, including regulatory support, contract manufacturing, second-source manufacturing development and CMC supplies; operating losses may fluctuate.

• Additional capital may be needed for development, regulatory approval and commercialization; funding needs depend on clinical progress and regulatory and commercial variability.