Avalyn Announces Multiple Presentations on its Lead Program, AP01, for Pulmonary Fibrosis and its Approach to Developing Novel Inhaled Therapies for Lung Diseases at the 2024 American Thoracic Society International Conference

Presentations to Include Long-term Safety and Efficacy Data from the ATLAS Trial Extension Study of AP01 (Inhaled Pirfenidone) for Pulmonary Fibrosis

Avalyn to be featured in ATS Mini Theater Program and Respiratory Innovation Summit

CAMBRIDGE, Mass., May 13, 2024 (GLOBE NEWSWIRE) — Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced multiple presentations at the 2024 American Thoracic Society (ATS) International Conference being held May 17-22, 2024 in San Diego, CA. Avalyn will also be featured in the ATS Industry Theater program, where the Company will share information about its Phase 2b trial evaluating AP01, a novel formulation of inhaled pirfenidone, for the treatment of progressive pulmonary fibrosis.

Avalyn’s presentations at ATS will include long-term efficacy and tolerability data from the ongoing open-label extension portion of its ATLAS trial evaluating AP01 in patients with pulmonary fibrosis. Members of Avalyn leadership will also provide a poster presentation and moderate a panel during the Respiratory Innovation Summit, an associated meeting that unites pharma business development, venture capital, government, academia, and clinical medicine to advance respiratory discovery.

“We are thrilled to have a lineup of presentations at ATS and are particularly excited to share the long-term efficacy and safety data on our flagship candidate, AP01, which bolsters our confidence in our planned Phase 2b trial in progressive pulmonary fibrosis,” said Lyn Baranowski, CEO of Avalyn Pharma. “These data, alongside our other presentations, underscore the transformative potential we aim to have by offering safe and effective inhaled therapies for patients with this life-threatening disease. Our showcase at ATS is a testament to the remarkable dedication and efforts of the Avalyn team plus the physicians and medical teams with whom we are working to address the critical needs in treating pulmonary fibrosis.”

Avalyn’s abstracts for the conference are available on the ATS’s 2024 online program and the Company’s event schedule is outlined as follows:

ATS 2024 Respiratory Innovation Summit

Poster Presentation: Avalyn Pharma – Developing Targeted Inhaled Therapies for Patients with Rare Respiratory Diseases
Presenter: Allison Trucillo, M.D., Vice President, Medical Affairs at Avalyn Pharma
Time: Poster available for viewing beginning May 17, 2024, at 5:00 p.m. PT
Location: Manchester Grand Hyatt San Diego

Panel: Revisiting the Pulmonary Functions Test
Moderator: Craig S. Conoscenti, M.D., FCCP, ATSF, Senior Vice President, Clinical Development at Avalyn Pharma
Time: May 18, 2024, at 3:45 p.m. PT
Location: Manchester Grand Hyatt San Diego

ATS 2024 Poster Presentations

Avalyn will deliver three poster presentations on May 20, 2024, from 11:30 a.m. – 1:15 p.m. PT at the San Diego Convention Center, Area K, Hall H:

Title: Safety and Efficacy of Inhaled Pirfenidone (AP01) in the ATLAS Open-label Extension Study
Thematic Poster Session: B48, Poster #: 1242

Title: Inhaled Pirfenidone Reduces the Risk of Disease Progression: A Post-hoc Analysis of the ATLAS Study
Thematic Poster Session: B48, Poster #: 1244

Title: Differences in E-lung Biomarker Scores Between Treatment Groups in Post-hoc Analysis of the ATLAS Inhaled Pirfenidone Solution (AP01) for IPF Clinical Trial
Thematic Poster Session: B48, Poster #: 1251

ATS 2024 Industry Theater Conference Event

Title: Breathing Innovation: Inhaled Pirfenidone for the Treatment of Progressive Pulmonary Fibrosis
Presenters: Howard Lazarus, M.D., Chief Medical Officer at Avalyn Pharma; Steven Nathan, M.D., FCCP, Medical Director, Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital
Session: Interstitial Lung Disease
Time: May 20, 2024, at 1:00 p.m. PT
Location: San Diego Convention Center, Innovation Theater 2

ATS 2024 Scientific Symposium

Title: Designing a Clinical Trial with Diversity and Inclusion in Mind
Presenter: Craig S. Conoscenti, M.D., FCCP, ATSF, Senior Vice President, Clinical Development at Avalyn Pharma
Session: SPS6 – Population Diversity in Clinical Trials
Time: May 20, 2024, at 2:32 p.m. PT
Location: Marriott Marquis San Diego Marina, Marina Ballroom E, Level 3

About Avalyn Pharma
Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication to the site of disease. Avalyn’s pipeline is led by AP01, an optimized inhaled formulation of pirfenidone, which has been assessed in 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety over existing therapies. For more information, please visit avalynpharma.com.

Investor Contact:
Monique Allaire
THRUST Strategic Communications
monique@thrustsc.com