Avalyn Pharma (AVLN) Registration filing summary

Company overview and business model

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

• Pipeline includes AP01 (inhaled pirfenidone), AP02 (inhaled nintedanib), and AP03 (inhaled combination), targeting progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF).

• Proprietary drug-device combinations using exclusive rights to PARI’s eRapid® Nebulizer System.

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

Financial performance and metrics

• 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.

• Research and development expenses were $76.6 million in 2025, up from $45.8 million in 2024.

• Cash, cash equivalents, and marketable securities totaled $138.4 million at year-end 2025.

• No revenue generated to date; operations funded primarily through $389 million in equity capital and a $30 million term loan facility.

Use of proceeds and capital allocation

• Estimated net proceeds of $181.8 million (or $209.7 million if underwriters’ option exercised) based on a $17.00/share IPO price.

• Proceeds to fund AP01 through Phase 2b topline data and into Phase 3 ($150M), AP02 through Phase 2 topline data and into Phase 3 ($90M), AP03 through Phase 1 ($10M), additional R&D, working capital, and general corporate purposes.

• Expected to fund operations into 2029 based on current plans.