Avalyn Pharma (AVLN) Corporate presentation summary

Strategic vision and market opportunity

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

• Pulmonary fibrosis, especially IPF and PPF, represents a large US market with over 650,000 ILD patients and $42B+ implied market size.

• Current oral treatments have poor tolerability, leading to high discontinuation rates and a large untreated patient population.

• Inhaled delivery aims to improve efficacy and tolerability by increasing lung exposure and reducing systemic side effects.

• Raised $345M in an upsized IPO, with cash runway projected into 2029.

Clinical pipeline and development milestones

• AP01 (inhaled pirfenidone) completed global Phase 2b MIST study enrollment in PPF; topline data expected 2H27.

• AP02 (inhaled nintedanib) initiated Phase 2 AURA trial in IPF; topline data anticipated late 2027.

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

• Over 4 years of long-term data support AP01’s safety and efficacy, with some patients on therapy for 5+ years.

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

Clinical data and product differentiation

• AP01 demonstrated improved tolerability and significant dose-dependent stabilization of lung function in IPF and PPF patients.

• Over 70% of patients on AP01 100mg BID showed stabilization or reversal of fibrosis, with strong correlation between lung function, fibrosis, and quality of life.

• Inhaled AP01 achieves broad lung deposition, including in severe disease, as shown by in silico and imaging studies.

• AP02 provides 27x higher lung exposure and 17x lower systemic exposure compared to oral nintedanib, with no significant adverse events at effective doses.

• Combination therapy (AP03) is enabled by inhaled delivery, potentially overcoming tolerability challenges seen with oral combinations.