Avalyn Pharma Ord Shs (Proposed)

Avalyn Pharma Inc. is a clinical-stage biopharmaceutical company engaged in inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases with significant unmet needs. The Company's pipeline is focused on treating pulmonary fibrosis. It has three approved oral antifibrotic therapies for pulmonary fibrosis: pirfenidone; nintedanib, and nerandomilast. Its clinically advanced candidates, AP01 and AP02, are inhaled formulations of pirfenidone and nintedanib for the treatment of progressive pulmonary fibrosis and idiopathic pulmonary fibrosis, respectively. It has completed ATLAS, a Phase Ib clinical trial of AP01 in patients with IPF. AP02 is being evaluated in AURA, a global Phase II clinical trial for the treatment of IPF. It is also advancing AP03 into a Phase I clinical trial. AP03 is a fixed-dose combination of inhaled pirfenidone, and nintedanib designed to deliver dual antifibrotic mechanisms with the potential for additive or synergistic benefit.