Avalyn Pharma (AVLN) Registration filing summary

Company overview and business model

• Clinical-stage biopharmaceutical company developing inhaled therapies for rare respiratory diseases, focusing on pulmonary fibrosis and interstitial lung diseases.

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

• Utilizes exclusive license to PARI’s eRapid® Nebulizer System for drug delivery, aiming to improve efficacy and tolerability over oral therapies.

• Strategy centers on advancing late-stage clinical programs, developing combination therapies, and expanding into additional rare pulmonary diseases.

Financial performance and metrics

• No product revenue to date; operations funded by $389 million in equity capital from leading healthcare investors.

• 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, reflecting increased clinical activity.

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

Use of proceeds and capital allocation

• Estimated net proceeds of $258.7 million (up to $298.2 million with full underwriter option) at $17.00 per share IPO price.

• Proceeds allocated to advance AP01 through Phase 2b and into Phase 3 ($150M), AP02 through Phase 2 and into Phase 3 ($90M), AP03 through Phase 1 ($10M), with the remainder for R&D, working capital, and general corporate purposes.

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