Avalyn Pharma (AVLN) investor relations material

Company overview and disease focus

• Recently completed IPO and attending first investor conference as a public company.

• Focused on pulmonary fibrosis, a deadly lung disease with poor survival rates and limited effective treatments.

• Less than 10% of U.S. patients use current oral therapies due to poor tolerability.

Product pipeline and clinical progress

• Developing inhaled versions of pirfenidone (AP01) and nintedanib (AP02) to improve tolerability and lung exposure.

• AP01 is in a global phase IIb (MIST) study, nearing full enrollment, with data expected about a year after completion.

• AP02 is in a global phase IIa study, with readout expected by late 2027; both programs aim to move into phase III.

• Combination program (AP03) targeting fixed-dose combos is planned to enter phase I later this year.

Clinical rationale and data

• Inhaled delivery allows for over 10-fold dose reduction with better lung exposure and fewer systemic side effects.

• Phase I-B and long-term data show stabilization of lung function in both IPF and PPF patients over four years.

• MIST study uses established criteria to ensure comparable patient populations and endpoints.