Savara (SVRA) investor relations material

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 does not address the underlying disease.

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

• Disease burden includes high healthcare utilization, comorbidities, and long diagnostic delays, with an average of 18 months from first physician visit to diagnosis.

• Most patients have moderate or severe disease, and all are at risk for fatal complications if untreated.

MOLBREEVI clinical development and efficacy

• MOLBREEVI (molgramostim inhalation solution) is an investigational, once-daily inhaled biologic delivered 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 significant improvements in quality of life (SGRQ scores) and exercise capacity, with durable benefits observed in open-label extension.

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

• Real-world case series support clinical trial findings, with all patients responding and no WLL needed after one year on MOLBREEVI.

Safety and tolerability

• MOLBREEVI was well tolerated, with low discontinuation rates and no deaths attributed to the drug.

• Most common adverse events included cough, COVID-19, pyrexia, and nasopharyngitis, with similar rates between MOLBREEVI and placebo.

• No study discontinuations due to treatment-related adverse events in the open-label period.