Avalyn Pharma (AVLN) Registration filing summary

Company overview and business model

• Clinical-stage biopharmaceutical company focused on inhaled therapies for serious, rare respiratory diseases, primarily pulmonary fibrosis.

• Pipeline includes AP01 (inhaled pirfenidone), AP02 (inhaled nintedanib), and AP03 (inhaled combination of pirfenidone and nintedanib).

• Strategy leverages exclusive rights to PARI’s eRapid Nebulizer System for targeted lung delivery.

• Business model aims to improve efficacy and tolerability over current oral antifibrotics, addressing significant unmet needs.

Financial performance and metrics

• No revenue to date; net losses of $85.2 million in 2025 and $49.7 million in 2024.

• Accumulated deficit of $265.4 million as of December 31, 2025.

• Cash, cash equivalents, and marketable securities of $138.4 million as of December 31, 2025.

• Research and development expenses increased to $76.6 million in 2025, driven by clinical trial progression.

• Raised $389 million in equity capital from leading healthcare investors.

Use of proceeds and capital allocation

• Net proceeds from the IPO, together with existing cash, will fund continued development of AP01, AP02, and AP03, as well as additional R&D programs.

• Remaining funds allocated to working capital and general corporate purposes.

• May use a portion for in-licensing, acquisitions, or investments in complementary businesses or technologies.