Savara (SVRA) Corporate presentation summary

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 high disease burden, including progressive shortness of breath, fatigue, increased infection risk, and potential need for lung transplant.

• Healthcare utilization is significantly higher for PAP patients, with increased outpatient, inpatient, and ER visits compared to controls.

• Diagnosis is often delayed, with an average of 18 months from first physician visit to diagnosis, highlighting the need for better awareness and testing.

MOLBREEVI clinical development and results

• MOLBREEVI (molgramostim inhalation solution) is an investigational inhaled biologic delivered 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) and exercise capacity, with favorable safety and tolerability profile.

• 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 to MOLBREEVI and no need for WLL after one year of treatment.

Regulatory, intellectual property, and market opportunity

• MOLBREEVI has received Orphan Drug, Fast Track, and Breakthrough Therapy designations in the U.S., and Orphan Drug and Innovation Passport in Europe and the UK.

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

• U.S. addressable market is estimated at ~5,500 patients, with a concentrated provider landscape and most patients classified as moderate or severe.

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

• European market development is underway, with key centers mapped and a total addressable market of ~5,200 patients in EU4+UK.