Savara (SVRA) Corporate presentation summary

Disease overview and unmet need

• 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; current treatment is invasive whole lung lavage (WLL), which is burdensome and does not address the underlying disease.

• Patients experience significant morbidity, including progressive shortness of breath, fatigue, increased infection risk, and potential need for lung transplantation.

• Disease burden is high, with increased healthcare utilization, comorbidities, and longer hospital stays compared to matched controls.

Clinical development and trial results

• MOLBREEVI (molgramostim inhalation solution) is an investigational inhaled biologic therapy for autoimmune PAP, administered via a proprietary eFlow® nebulizer.

• The Phase 3 IMPALA-2 trial met its primary endpoint, showing statistically significant improvement in DLCO % at 24 and 48 weeks versus placebo.

• Secondary endpoints included improvements in quality of life (SGRQ scores), activity, and exercise capacity, with favorable safety and tolerability profile.

• MOLBREEVI reduced pulmonary surfactant burden and decreased the need for rescue WLL compared to placebo.

• Real-world case series support clinical trial findings, showing improved lung function and reduced disease burden in patients treated with MOLBREEVI.

Regulatory and intellectual property status

• MOLBREEVI has received Orphan Drug, Fast Track, and Breakthrough Therapy designations in the U.S., and Orphan Drug and Innovation Passport designations in Europe and the UK.

• U.S. BLA and EU MAA filings are validated, with potential approvals expected in 2026-2027.

• Upon approval, 12 years of U.S. biologic exclusivity is anticipated, with multiple patents pending or granted for the drug, device, and combination.