Savara (SVRA) investor relations material

Disease and unmet need

• GM-CSF autoantibodies block signaling and surfactant clearance, causing impaired oxygenation and potentially hypoxemic respiratory failure.

• No approved drugs for autoimmune PAP in the U.S. or Europe; whole lung lavage is invasive, does not correct the underlying disease process and may need repeating.

• Diagnosis can be delayed: patients average 12 months from first symptoms to seeing a physician and another 18 months from first physician visit to diagnosis.

• Versus matched controls, patients had 3.5x the Charlson Comorbidity Index, 167% more outpatient visits and 505% more inpatient visits.

IMPALA-2 clinical results

• Investigational MOLBREEVI is 300 μg once daily via the eFlow nebulizer system, with a treatment time of ~5 minutes.

• Phase 3 IMPALA-2 randomized 164 patients; the primary endpoint was change from baseline in DLCO at Week 24, with placebo-controlled treatment through Week 48.

• DLCO improved by 9.8% vs 3.8% at Week 24 (LSM difference 6.00; p=0.0007) and 11.6% vs 4.7% at Week 48 (difference 6.90; p=0.0008).

• SGRQ Total Score improved at Week 24 (LSM difference -6.59; p=0.0072); SGRQ Activity at Week 24 and exercise capacity at Week 48 were nominally significant (p=0.0149 and p=0.0234).

• Treatment discontinuation was 3%, none due to drug-related adverse events; all double-blind completers entered the open-label period, where reported retention was 94%.

Regulatory and commercial readiness

• The BLA was filed in Q1 2026, with a PDUFA date of Nov. 22, 2026; EU and UK marketing applications were validated, with potential approvals shown for 2027.

• MOLBREEVI has U.S. Orphan Drug, Fast Track and Breakthrough Therapy designations; the presentation cites 12 years of U.S. biologic exclusivity upon approval.

• Commercial preparations include a no-charge GM-CSF autoantibody testing program, 30 customer-facing commercial personnel starting in Q2 2026 and PANTHERx Rare as exclusive U.S. specialty pharmacy partner.

• Expected orphan-drug pricing is $400K–$500K per patient annually; the U.S. opportunity estimate is ~5,500 patients and >$2B potential.

• Cash and short-term investments were ~$173M as of June 30, 2026, with access to up to an additional ~$150M of non-dilutive capital upon FDA approval.