Avalyn Pharma (AVLN) investor relations material

Company overview and market opportunity

• Focused on pulmonary fibrosis, a rare and deadly disease with significant unmet need and poor survival rates.

• Only about one-third of patients use current oral therapies due to severe side effects and poor tolerability.

• The branded market exceeds $4 billion, but current drugs reach less than 10% of patients; total addressable market estimated at over $42 billion.

• Newer drugs like Jascayd show that improved tolerability can unlock significant commercial potential.

Technology, device, and barriers to entry

• Developed inhaled therapies using a patented handheld nebulizer licensed from PARI, tailored for frail, elderly patients.

• Device and formulation patents, plus device exclusivity, create strong barriers to entry and durable revenue streams.

• No FDA bioequivalence pathway for inhaled nebulized products, making generic competition challenging.

• Nebulizer allows normal breathing and is more suitable for the target population than dry powder inhalers.

Clinical development and data highlights

• Lead candidate AP01 (inhaled pirfenidone) shows improved tolerability and potentially better efficacy versus oral versions, with better lung exposure at lower doses.

• ATLAS study demonstrated stabilization of lung function and, in some cases, reversal of fibrosis on imaging; long-term extension shows durable benefit.

• Adverse events are milder and less frequent than with oral drugs, even in sicker patient populations.

• Ongoing phase II-B MIST study is designed as a pivotal trial, with top-line data expected in the second half of next year.