Avalyn Pharma (AVLN) Corporate presentation summary

Strategic vision and market opportunity

• Focus on inhaled therapies for rare lung diseases, targeting a multi-billion dollar addressable market with significant unmet needs.

• Pulmonary fibrosis represents a large US market with over 650,000 ILD patients and annual brand pricing exceeding $150,000 per patient.

• Well-capitalized with $345M raised in an upsized IPO in April 2026, providing cash runway into 2029.

• Expert team with deep experience in developing and commercializing inhaled therapies.

Clinical pipeline and development milestones

• AP01 (inhaled pirfenidone) is in a global Phase 2b trial for PPF, with enrollment completion expected mid-2026 and data in 2H27.

• AP02 (inhaled nintedanib) is in Phase 2 for IPF, with first patient dosed in 1Q26 and data expected late 2027.

• AP03 (inhaled pirfenidone + nintedanib fixed-dose combination) Phase 1 trial initiation anticipated late 2026, with data in 2H27.

• Multiple clinical catalysts expected in 2026 and beyond, including key readouts and trial initiations.

Differentiated inhaled delivery platform

• Inhaled delivery increases lung exposure at over 10x lower doses than oral, while reducing systemic exposure.

• Proprietary, handheld nebulized formulation delivered by a patented, FDA-cleared device, with administration under 10 minutes twice daily.

• Device exclusivity for molecules and optimal aerosol particle size for peripheral airway deposition.