Savara (SVRA) investor relations material

Disease overview and unmet need

• Autoimmune PAP is a rare, chronic lung disease caused by GMCSF autoantibodies, leading to surfactant accumulation and progressive respiratory symptoms.

• No approved drugs exist in the U.S. or Europe; current standard is whole lung lavage, an invasive, non-curative procedure.

• Disease can progress to fibrosis and lung transplant in severe cases.

Mobrevi (morgamostim) clinical development and results

• Mobrevi is a novel inhaled biologic delivered via a proprietary eFlow nebulizer, dosed once daily.

• The phase 3 Impala 2 trial met its primary endpoint (DLCO improvement at 24 weeks) and showed durable effect at 48 weeks.

• Secondary endpoints, including quality of life and exercise capacity, were also positive or nominally significant.

• Safety profile was favorable, with a 3% discontinuation rate and no drug-related adverse events.

• All 159 trial completers entered the open-label extension; results published in the New England Journal of Medicine.

Regulatory and intellectual property status

• U.S. BLA resubmission planned for December, with potential PDUFA in August 2026 if priority review is granted.

• EU and UK MAA submissions targeted for Q1 2025, with possible approval in Q1 2027.

• Mobrevi holds orphan, fast track, and breakthrough designations in the U.S., and orphan plus innovative designations in Europe and UK.

• Regulatory exclusivity of 12 years in the U.S. and ongoing global patent prosecution.