Current Report · Items 1.01, 9.01 · 8-K

Avalyn Pharma Inc.

AVLNNASDAQEQUITYCurrent

Entry into a Material Definitive Agreement

Filed Jul 1, 2026Accepted Jul 1, 2026, 5:20 PM EDTCIK 1540171Accession 0001193125-26-292834

Company context

Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.

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Disclosure sections

Items 1.01, 9.01

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Item 1.01Item 1.01 - Entry into Material Agreement

Item 1.01 Entry into a Material Definitive Agreement. On June 29, 2026 (the “Effective Date”), Avalyn Pharma Inc. (the “Company”) entered into a First Amendment to the Sublease (the “Sublease Amendment”), which amends that certain Sublease Agreement (the “Sublease Agreement”) with CRISPR Therapeutics, Inc. (the “Sublandlord”), dated as of August 29, 2025, providing for the lease of approximately 8,774 rentable square feet in the building located at 105 West First Street, Boston, Massachusetts (the “Premises”). Pursuant to the Sublease Amendment, the Sublandlord and the Company, as Subtenant, have agreed to an expansion of the Premises from approximately 8,774 rentable square feet to approximately 13,708 rentable square feet as of the Effective Date. Additionally, under the terms of the Sublease Amendment, the Company’s future minimum lease payments will increase by approximately $924,000 over the remaining lease term. Except as modified by the Sublease Amendment, the terms of the Sublease Agreement remain in full force and effect. The foregoing summary of the material terms of the Sublease Amendment does not purport to be a complete description and is qualified in its entirety by reference to the complete text of the Sublease Amendment, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.