Financing led by Suvretta Capital Management and SR One with participation from 16 additional healthcare investors
Proceeds will support key clinical milestones across all of Avalyn’s pipeline programs
CAMBRIDGE, Mass., July 22, 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 the closing of an oversubscribed $100 million Series D financing. The raise was co-led by Suvretta Capital Management and SR One, with participation from Novo Holdings A/S, F-Prime, Perceptive Xontogeny Venture Funds, Norwest, Eventide Asset Management, Wellington Management, Vida Ventures, Catalio Capital Management, RiverVest Venture Partners, Pivotal bioVenture Partners, TPG Biotech, Hamilton Square Partners Management, LP (HSq), Rock Springs Capital, Surveyor Capital (a Citadel company), funds and accounts advised by T. Rowe Price Associates, Inc., and Piper Heartland. In conjunction with the financing, David Friedman, M.D., Managing Director of Suvretta Capital Management, joined Avalyn’s Board of Directors and Diamantis Xylas, M.D., Partner and Head of Research of Catalio Capital Management, joined as a Board Observer.
“Completing a significant round of financing despite the challenging market conditions is a testament to our innovative approach to developing potentially life-saving medicines for patients with pulmonary fibrosis,” said Lyn Baranowski, CEO of Avalyn. “We’ve made tremendous progress across our entire portfolio, completing Phase 1 clinical trials of AP02 and initiating a global Phase 2b clinical trial of AP01. With the support from an esteemed group of investors, we will continue the expeditious advancement of our clinical programs, while also bringing our third program into the clinic, all of which positions Avalyn for an exciting future of growth.”
Proceeds will support key clinical milestones across Avalyn’s pipeline programs in pulmonary fibrosis, including the late-stage development of Avalyn’s lead programs: optimized inhaled formulations of pirfenidone (AP01) and nintedanib (AP02), as well as the advancement of the pirfenidone/nintedanib fixed dose combination (AP03) into Phase 1 clinical trials.
AP01 is currently being evaluated in a global Phase 2b MIST trial in patients with progressive pulmonary fibrosis (PPF). In the completed Phase 1b ATLAS trial in patients with idiopathic pulmonary fibrosis (IPF), AP01 reduced lung function decline in a dose-responsive manner and demonstrated potential disease-modifying effects on fibrosis as observed by analyses of high-resolution computed tomography (HRCT) scans. In an ongoing open-label extension trial of patients with different forms of pulmonary fibrosis, AP01 has shown long-term safety and efficacy for more than 4.5 years. In addition, Avalyn recently completed Phase 1 trials of AP02, which demonstrated safety and tolerability at all dose levels and a favorable pharmacokinetic profile. The company plans to initiate a Phase 2 clinical trial for AP02 in patients with IPF.
“Avalyn is at an exciting point in its evolution with multiple transformative product opportunities in clinical development, each with significant commercial potential,” said David Friedman, M.D., Managing Director of Suvretta Capital Management. “The clinical data generated to date for AP01 and AP02 are clinically compelling on their own, but when compared to the data for the currently approved oral treatments, they support the potential for Avalyn to achieve disease modification for patients with pulmonary fibrosis. We are thrilled to back such an exceptional team translating breakthrough science into real clinical impact, and what we believe will be a category-changing company in respiratory medicine.”
“Lyn and team are executing a clear growth strategy for Avalyn rooted in both clinical insight and operational excellence,” said Jill Carroll, Partner at SR One and an Avalyn Board Director. “On behalf of the entire Board, we’re proud of their patient-focused approach and commitment to innovation and scientific rigor, which positions this company to redefine the future of what’s possible for patients suffering from pulmonary fibrosis.”
Avalyn’s earlier-stage pipeline includes AP03, a next-generation inhaled fixed-dose combination of AP01 and AP02. Clinical data indicate that the combination of pirfenidone and nintedanib may offer additive, or even synergistic, efficacy advantages over either product alone. Combining these oral therapies has not been feasible due to the additive side effects when taken together. Inhaled delivery has the potential to solve the tolerability challenges of the oral antifibrotics, enabling Avalyn to combine these medicines effectively for the first time. Avalyn is advancing IND-enabling studies for AP03 and is planning a Phase 1 clinical trial.
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). 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
