Savara (SVRA) investor relations material

Disease overview and burden

• Autoimmune PAP is a rare, chronic lung disease caused by GM-CSF autoantibodies, leading to impaired surfactant clearance and hypoxemic respiratory failure.

• No approved drugs exist in the U.S. or Europe; whole lung lavage (WLL) is the only treatment, which is invasive and burdensome.

• Patients experience progressive shortness of breath, fatigue, increased infection risk, and may require lung transplantation.

• Autoimmune PAP patients have significantly higher healthcare utilization, comorbidities, and longer hospital stays compared to controls.

• Diagnosis is often delayed, with an average of 18 months from first physician visit to diagnosis.

MOLBREEVI clinical development and results

• MOLBREEVI (molgramostim inhalation solution) is an investigational therapy delivered via a proprietary eFlow® nebulizer system.

• Phase 3 IMPALA-2 trial showed MOLBREEVI significantly improved lung function (DLCO%) at 24 and 48 weeks versus placebo (p=0.0007, p=0.0008).

• Statistically significant improvements were observed in quality of life (SGRQ Total Score) and surfactant burden (GGO score).

• MOLBREEVI was well-tolerated with low discontinuation rates and a safety profile comparable to placebo.

• Real-world case series support clinical trial findings, showing improved lung function and reduced need for WLL.

Regulatory and intellectual property status

• MOLBREEVI has orphan drug, fast track, and breakthrough therapy designations in the U.S.; orphan drug and innovation designations in Europe and the UK.

• Pending and granted patents cover the drug formulation and drug/device combination; 12-year biologic exclusivity expected upon approval in the U.S.

• BLA filed in the U.S. with PDUFA date set for November 22, 2026; MAA validated in EU and UK with potential approvals in 2027.