Avalyn Pharma

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General Information
Business:

(Incorporated in Delaware)

We are a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases with significant unmet needs. Our approach is designed to address the limitations of current oral therapies by delivering optimized inhaled formulations of approved oral medicines directly to the lungs to enhance efficacy and minimize systemic exposure that contributes to side effects and treatment discontinuation.

Our current pipeline is focused on treating pulmonary fibrosis, a life-threatening disease with a median survival of three to five years, which is a significantly shorter prognosis than that observed for many forms of cancer. Pulmonary fibrosis is characterized by scarring of the lungs, which can lead to a decline in lung function, progressive shortness of breath, reduced quality of life, and increased mortality risk.

There are currently three approved oral antifibrotic therapies for pulmonary fibrosis: pirfenidone, or ESBRIET®; nintedanib, or OFEV®; and nerandomilast, or JASCAYD®. While these oral antifibrotics slow fibrosis progression, none stop progression entirely. In addition, their use is frequently limited by tolerability challenges associated with their systemic delivery. Due to their side effects, around 50% of patients who start treatment with available therapies discontinue within one year. Despite limited use, ESBRIET® and OFEV® generated more than $4.0 billion in gross global sales in 2024.

Our most clinically advanced candidates, AP01 and AP02, are inhaled formulations of pirfenidone and nintedanib for the treatment of progressive pulmonary fibrosis, or PPF, and idiopathic pulmonary fibrosis, or IPF, respectively. We have completed ATLAS, a Phase 1b clinical trial of AP01 in patients with IPF. Patients from ATLAS transitioned into an ongoing open-label extension, or OLE, trial, along with compassionate-use cohorts of patients with IPF and PPF. We currently have over four and a half years of data demonstrating a favorable tolerability profile and preliminary data on clinical activity, including near-stabilization of lung function.

AP01 is currently being evaluated in MIST, a global Phase 2b clinical trial for the treatment of PPF. We have also completed Phase 1 trials of AP02 in healthy adult volunteers and patients with IPF. AP02 is currently being evaluated in AURA, a global Phase 2 clinical trial for the treatment of IPF. We are also advancing AP03 into a Phase 1 clinical trial. AP03 is a fixed-dose combination of inhaled pirfenidone and nintedanib designed to deliver dual antifibrotic mechanisms with the potential for additive or synergistic benefit.

We believe our inhaled therapies, if successfully developed and approved, may offer improved tolerability and efficacy for long-term treatment. These programs are intentionally designed, leveraging our deep expertise in rare respiratory diseases, advanced inhaled drug formulation, and our exclusive license to customize the delivery device.

Our Approach to Transforming the Treatment Paradigm for Pulmonary Fibrosis

Interstitial lung diseases, or ILDs, are a heterogeneous group of rare pulmonary disorders, comprising over 200 distinct conditions, many of which lack approved or effective treatments. ILDs are characterized by varying degrees of inflammation, fibrosis, or both. These conditions impair gas exchange and patients’ quality of life, or QoL, by causing chronic breathlessness, fatigue, coughing, and reduced ability to perform daily activities.

Pulmonary fibrosis is a pathologic phenotype observed across a large subset of ILDs characterized by chronic injury, aberrant repair, progressive, typically irreversible, fibrosis, and stiffening of lung tissue. Although different ILDs have distinct underlying etiologies, pathophysiology, and clinical courses, many forms of ILD can ultimately result in pulmonary fibrosis. Once pulmonary fibrosis develops, disease progression may continue even if the underlying cause of ILD is treated or removed. ILDs represent a significant global health burden, affecting over 650,000 in the U.S. alone, of which approximately 300,000 have pulmonary fibrosis. The median survival of pulmonary fibrosis is three to five years, which is a significantly shorter prognosis than that observed for many forms of cancer.

There are two primary clinical forms of pulmonary fibrosis: IPF and PPF. IPF is an ILD of unknown etiology, affecting approximately 120,000 people in the U.S. PPF, by contrast, refers to ILDs with a known etiological factor, such as autoimmune disease or exposure to allergens, where a subset of patients develop a progressive pulmonary fibrotic phenotype. PPF represents a more prevalent form of pulmonary fibrosis, affecting approximately 180,000 people in the U.S.

Note: Net loss is for the year that ended Dec. 31, 2025.

Note: Avalyn Pharma did not generate any revenue for the year that ended Dec. 31, 2025.

(Note: Avalyn Pharma filed its S-1 on April 8, 2026, without disclosing the terms for its IPO. Estimated proceeds are $100 million, but that is likely to be a placeholder figure.)
Industry: Pharmaceuticals
Employees: 51
Founded: 2011
Contact Information
Address 105 W First Street Boston, Massachusetts 02127
Phone Number (206) 707-0340
Web Address http://www.avalynpharma.com/
View Prospectus: Avalyn Pharma
Financial Information
Market Cap
Revenues $0 mil (last 12 months)
Net Income $-85.2 mil (last 12 months)
IPO Profile
Symbol AVLN
Exchange NASDAQ
Shares (millions): 0.0
Price range $0.00 - $0.00
Est. $ Volume $100.0 mil
Manager / Joint Managers Morgan Stanley/Jefferies/Evercore ISI/Guggenheim Securities
CO-Managers
Expected To Trade:
Status: TBA
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