Savara (SVRA) Corporate presentation summary

Disease overview and burden

• Autoimmune PAP is a rare, chronic lung disease caused by GM-CSF autoantibodies, leading to impaired surfactant clearance and reduced oxygenation, resulting in progressive respiratory failure and increased risk of infection, fibrosis, and need for lung transplant.

• No approved drugs exist in the U.S. or Europe; the only current treatment is whole lung lavage (WLL), an invasive, burdensome procedure that does not address the underlying disease mechanism.

• Patients experience significant morbidity, including fatigue, decreased exercise tolerance, and frequent hospitalizations, with higher rates of comorbidities and healthcare utilization compared to controls.

• Diagnosis is often delayed, with an average of 18 months from first physician visit to diagnosis, and patients frequently undergo cycles of misdiagnosis and inappropriate treatment.

Investigational therapy: MOLBREEVI

• MOLBREEVI (molgramostim inhalation solution) is an investigational, once-daily inhaled biologic delivered via a proprietary eFlow® Nebulizer System, designed to address the underlying pathophysiology of autoimmune PAP.

• Phase 3 IMPALA-2 trial demonstrated statistically significant improvements in lung function (DLCO%), quality of life (SGRQ scores), and exercise capacity, with a favorable safety and tolerability profile.

• MOLBREEVI reduced pulmonary surfactant burden as measured by ground glass opacity on CT and decreased the need for rescue WLL compared to placebo.

• Real-world case series showed all patients responded to MOLBREEVI with improved lung function, reduced symptoms, and no need for WLL after one year.

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.

• Biologics License Application (BLA) was filed in the U.S. in Q1 2026, with potential FDA approval expected by August 2026; European and UK submissions are also underway.

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