Every 8-K that Avalyn Pharma Inc. (AVLN) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow AVLN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full AVLN filings page.
Avalyn Pharma Inc. (AVLN) disclosed that on September 15, 2026, its board appointed Robert Meyer, M.D. as a Class II director, with a term expiring at the 2028 annual meeting of stockholders. The board determined that he is independent under Nasdaq listing standards.
Dr. Meyer has extensive regulatory and pulmonary drug-development experience, including senior roles at the U.S. Food and Drug Administration and Merck & Co., Inc., and prior board service at several public life sciences companies. Under Avalyn’s Non-Employee Director Compensation Policy, he will receive a $40,000 annual cash retainer and received an initial stock option for 31,182 shares vesting over three years. He will also be eligible for annual option grants for 15,591 shares, vesting on the earlier of the first anniversary of grant or the next annual meeting, while he remains a director. Each option will have an exercise price equal to the fair market value of Avalyn common stock on the grant date.
Avalyn Pharma Inc. reported second quarter 2026 results and pipeline progress. The company completed global enrollment of the MIST Phase 2b trial of AP01 in progressive pulmonary fibrosis, over-enrolling to 398 patients versus a 375 target, with topline data expected in the second half of 2027. Enrollment in the AURA Phase 2 trial of AP02 in idiopathic pulmonary fibrosis is ongoing, and a Phase 1 study of combination candidate AP03 remains planned to start by the end of 2026.
Cash, cash equivalents and marketable securities totaled $413.5 million as of June 30, 2026, including approximately $316.6 million of IPO proceeds, supporting a projected cash runway into 2029. Second quarter 2026 research and development expenses were $24.7 million and general and administrative expenses were $6.6 million, leading to a net loss of $28.9 million for the quarter.
Avalyn Pharma Inc. entered into a First Amendment to its sublease with CRISPR Therapeutics, expanding its Boston headquarters space at 105 West First Street.
The leased premises increase from approximately 8,774 to 13,708 rentable square feet as of June 29, 2026. Future minimum lease payments will rise by about $924,000 over the remaining lease term, while all other sublease terms remain in effect.
Avalyn Pharma filed an 8-K to share that it has completed target enrollment of 375 patients in its global Phase 2b MIST trial of AP01, an inhaled pirfenidone therapy for progressive pulmonary fibrosis. The randomized, double-blind, placebo-controlled study compares two AP01 doses against placebo over 52 weeks.
The primary goal is to assess change in lung function, measured by forced vital capacity, after one year of treatment. Avalyn expects to report topline 12‑month clinical results in the second half of 2027, which will help clarify AP01’s potential to preserve lung function and improve quality of life in this serious respiratory disease.
Avalyn Pharma reported first-quarter 2026 results and highlighted recent progress across its inhaled pulmonary fibrosis pipeline. The company recorded a net loss of $26.9 million for the quarter, compared with $17.5 million a year earlier, driven mainly by higher research and development spending.
R&D expenses rose as Avalyn advanced its AP01 Phase 2b MIST trial in progressive pulmonary fibrosis and continued enrollment in the AP02 Phase 2 AURA trial in idiopathic pulmonary fibrosis. A Phase 1 trial of its AP03 combination therapy is planned to start by the end of 2026.
The company completed an upsized initial public offering in May, raising gross proceeds of $345.0 million at $18.00 per share. Together with $123.1 million in cash, cash equivalents, and marketable securities as of March 31, 2026, Avalyn projects it has sufficient capital to fund current operating plans into 2029.
Avalyn Pharma Inc. reported corporate governance changes tied to its initial public offering. Immediately before the IPO, the company filed an amended and restated certificate of incorporation in Delaware, fully replacing its prior charter.
The new charter authorizes 700,000,000 shares of common stock, split into 500,000,000 voting common shares and 200,000,000 non-voting common shares, and authorizes 10,000,000 shares of undesignated preferred stock that the board may issue in one or more series. It also removes references to the company’s previous preferred stock series.
At the same time, Avalyn’s amended and restated bylaws became effective. These bylaws overhaul procedures for stockholder meetings, introduce advance notice requirements for stockholder proposals and director nominations, and align the bylaws with the updated charter provisions.