Avalyn: Targeted Inhalation Therapy Company Raises $175 Million

By Noah Long ● Oct 5, 2023

Avalyn Pharma – a clinical-stage biopharmaceutical company focused on developing targeted inhalation therapies for life-threatening pulmonary diseases – announced the closing of an oversubscribed $175 million Series C financing. Avalyn plans to use the funding to continue the development of its portfolio of inhalation therapies for interstitial lung disease that improve upon currently approved medications and advance lead clinical assets AP01 (inhaled pirfenidone) and AP02 (inhaled nintedanib) into mid-stage clinical trials.

The Series C funding round was co-led by Perceptive Xontogeny Venture Funds, SR One, and Eventide Asset Management, which were joined by new investors, Vida Ventures, Wellington Management, Rock Springs Capital, funds and accounts advised by T. Rowe Price Associates, Surveyor Capital (a Citadel Company), Catalio Capital Management, and Piper Heartland. The current investors – including Novo Holdings A/S, Norwest Venture Partners, F-Prime Capital, Pivotal bioVenture Partners, and RiverVest Venture Partners – also participated. Gianna Hoffman-Luca, Ph.D. of Perceptive Xontogeny Venture Funds, and Jill Carroll of SR One joined Avalyn’s Board of Directors in connection with the financing.

Even though oral pirfenidone has been shown to reduce the decline of lung function and mortality in patients with idiopathic pulmonary fibrosis (IPF), systemic exposure contributes to significant side effects, including nausea, rash, photosensitivity, weight loss, and fatigue, limiting its overall use in patients. In clinical trials, inhaled AP01 was well-tolerated and demonstrated enhanced efficacy compared to published oral pirfenidone results. And AP02 was well-tolerated in a recently completed open-label Phase 1a trial in IPF patients and healthy volunteers. Avalyn plans to advance AP01 into a Phase 2b trial and AP02 into a Phase 2a trial for patients with pulmonary fibrosis.

KEY QUOTES:

“Pulmonary fibrosis is a fatal disease with a median survival of only 3-5 years. Fewer than 30% of patients in the U.S. are treated with either of the two approved oral medicines today due to their significant tolerability challenges. There is an urgent need for effective treatments that patients can tolerate, which we believe can be addressed with inhaled delivery. In fact, our existing clinical data shows potential for both improved tolerability and efficacy. We are thrilled to have the support of such an esteemed group of investors to help realize our mission and impact patients’ lives.”

— Lyn Baranowski, CEO of Avalyn

“We at Perceptive Xontogeny Venture Funds are particularly compelled by the clinical data with AP01 showing preserved forced vital capacity in pulmonary fibrosis and significantly fewer side effects than oral pirfenidone. Avalyn’s business and scientific approach is highly differentiated, and we are proud to support the next phase of growth.”

— Dr. Hoffman-Luca

“The combination of the pipeline and data with such an accomplished team, with a track record of biotech leadership and pulmonology drug development, gives us faith in what Avalyn is trying to accomplish. I am excited to work with the leadership team and Board to help advance these programs and deliver a new era of respiratory treatments that could be paradigm-changing.”

— Jill Carroll of SR One

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