Avalyn Appoints Industry Veterans Jill Denning and Kimberley Cummings to Leadership

Appointments expand clinical and regulatory capabilities ahead of key program milestones

BOSTON, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on the development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced two key leadership appointments to strengthen its clinical and regulatory capabilities and drive its next phase of growth. Jill Denning, a clinical research executive with nearly three decades of drug development experience, was appointed senior vice president, clinical development operations, and Kimberley Cummings, Ph.D., a regulatory affairs executive with over two decades leading global regulatory strategy for biopharmaceutical companies, was appointed senior vice president, regulatory affairs.

"We are excited to welcome Jill and Kimberley to our leadership team as we continue to advance our portfolio and prepare for key clinical and regulatory milestones," said Lyn Baranowski, CEO of Avalyn. "Jill brings extensive experience leading clinical programs from early pharmacology through late-stage development, and her ability to bridge scientific insight with operational execution will be crucial as we continue to progress our programs through the clinic. Kimberley adds deep regulatory affairs expertise, including in rare diseases and combination products, which will be invaluable as we navigate regulatory pathways for our programs. Together, these appointments position Avalyn to advance our lead programs through clinical development and one step closer to our goal of bringing new treatments to patients with life-threatening pulmonary diseases."

Jill Denning joined Avalyn in September 2025 as senior vice president of clinical development operations. Jill is a key member of the clinical team responsible for drug development across our programs, including translating strategic priorities into executional plans. Prior to joining Avalyn, Ms. Denning most recently served as vice president of clinical development at Kinevant Sciences focusing on pulmonary sarcoidosis. Prior to that, she was vice president of clinical development at Altavant Sciences, where she focused on pulmonary arterial hypertension and bronchiolitis obliterans syndrome. Earlier in her career, Ms. Denning served on the team at Gilead Sciences and Pharmasset that advanced the first cure for Hepatitis C from early development through new drug application submission. She holds an M.A. in exercise physiology from the University of North Carolina at Chapel Hill and a B.S. in business administration from the State University of New York at Brockport.

Kimberley Cummings, Ph.D., joined Avalyn in October 2025 as senior vice president of regulatory affairs, where she is responsible for developing and executing the company’s regulatory affairs strategy. Dr. Cummings most recently served as senior vice president of regulatory affairs and clinical development at Neurogastrx, and previously, as vice president of regulatory affairs at Levo Therapeutics. Earlier in her career, Dr. Cummings held senior consulting roles at global CROs, where she led cross-functional teams and regulatory submissions spanning all phases of development. She earned her Ph.D. in Biomedical Sciences from the Medical College of Ohio, now part of the University of Toledo, and holds Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.

About Avalyn Pharma
Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and 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’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF) and is planning a Phase 2 clinical trial. For more information, please visit avalynpharma.com and follow us on LinkedIn.

Investor Contact:
Alex Straus, THRUST
alex@thrustsc.com
ir@avalynpharma.com

Media Contact:
Kat Lippincott, Deerfield Group
kat.lippincott@deerfieldgroup.com
media@avalynpharma.com

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