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 does not address the underlying disease.

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

• Healthcare utilization is significantly higher for PAP patients, with increased outpatient, inpatient, and ER visits, and longer hospital stays 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.

Investigational therapy: MOLBREEVI

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

• Phase 3 IMPALA-2 trial showed MOLBREEVI significantly improved lung function (DLCO%), quality of life (SGRQ scores), and exercise capacity compared to placebo.

• MOLBREEVI reduced pulmonary surfactant burden and decreased the need for rescue WLL during the trial.

• The drug 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 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 filed with PDUFA date set for August 22, 2026; EU and UK MAA submissions are underway with potential approvals in late 2026 or early 2027.

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