Savara (SVRA) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Regulatory and clinical progress

• FDA accepted the BLA for Molbreevi, assigned priority review, and set a PDUFA date for August 22nd, following positive global phase III IMPALA-2 results for aPAP.

• MAAs will be filed in the EU and UK by the end of March, advancing parallel regulatory strategies.

• Molbreevi demonstrated improvements in DLCO, SGRQ, exercise capacity, and surfactant burden, supporting confidence in approval.

Unmet need and therapeutic positioning

• aPAP currently lacks any approved therapies in the US, EU, or UK; the only available intervention is Whole Lung Lavage, a complex and non-curative procedure.

• Molbreevi targets the underlying pathophysiology by activating macrophages and restoring surfactant homeostasis, potentially offering the first chronic therapeutic option.

Market opportunity and patient population

• Claims analysis identified approximately 5,500 diagnosed aPAP patients in the US, about 16 per million, considered the new market floor.

• All diagnosed patients, regardless of disease severity, are expected to benefit from Molbreevi, with early intervention emphasized.