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 relies on 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.

• Healthcare utilization is high, with increased outpatient, inpatient, and ER visits, and longer hospital stays compared to matched controls.

Clinical development and efficacy of MOLBREEVI

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

• 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.

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

• Open-label extension data demonstrated durable, long-term benefits in lung function and quality of life.

Safety and real-world evidence

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

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

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