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 mechanism.

• 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 significant impact on quality of life.

MOLBREEVI clinical development and results

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

• Phase 3 IMPALA-2 trial met its primary endpoint: significant improvement in DLCO % at 24 and 48 weeks versus placebo (p=0.0007, p=0.0008).

• Statistically significant improvements were observed in quality of life (SGRQ Total Score) and surfactant burden (GGO score), with nominally significant gains in activity and exercise capacity.

• MOLBREEVI was well tolerated, with low discontinuation rates and a safety profile comparable to placebo.

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

Regulatory, intellectual property, and market opportunity

• MOLBREEVI has orphan drug, fast track, and breakthrough therapy designations in the U.S., and orphan drug and innovation designations in Europe and the UK.

• U.S. BLA and EU/UK MAA filings are underway, with potential FDA approval expected by Q3 2026.

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

• U.S. addressable market estimated at ~5,500 patients, with concentrated care among top 500 healthcare organizations.

• Orphan drug pricing expected at $400K–$500K per patient per year, with a potential U.S. market opportunity exceeding $2B.