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Company research

Avalyn Pharma Inc.

CIK 1540171Updated Sep 24, 2026

Name history
Genoa Pharmaceuticals, Inc. · through May 24, 2017

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About the company

Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary

8-K · 2026-06-17 · 0001193125-26-273405

Company description from the cited filing.

In the news

Seeking Alpha
SEC disclosures

Offerings

Registration 333-294932

424B4 · 2026-04-30 · 0001193125-26-197686

Terms from the governing filing for this registration; not a claim that the offering is open today.

Gross proceeds
300000006.0
Net proceeds
279000006.0
Deal price
18.0
Shares
16666667
Offering price
$18.00
Ticker
AVLN

Filing attachments

ck0001540171-ex99_1.htm · 8-K · 2026-08-12

EX-99.1 2 ck0001540171-ex99_1.htm EX-99.1 EX-99.1 Avalyn Reports Second Quarter 2026 Financial Results and Recent Business Highlights Completed enrollment of MIST global Phase 2b trial of AP01 with 398 patients; topline data expected in the second half of 2027 Two abstracts accepted for presentation at the European Respiratory Society (ERS) Congress, including data modeling AP01 lung tissue distribution Ended the second quarter of 2026 with $413.5 million in cash, cash equivalents and ma

8-K · 2026-08-12 · 0001193125-26-345807

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ck0001540171-ex99_1.htm · 8-K · 2026-06-17

EX-99.1 2 ck0001540171-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Avalyn Completes Target Enrollment in Phase 2b MIST Trial of AP01 (Inhaled Pirfenidone) for Patients with Progressive Pulmonary Fibrosis Company expects to report topline 12-month clinical results in the second half of 2027 BOSTON, MA, June 17, 2026 -- Avalyn Pharma Inc. (Nasdaq: AVLN) (Avalyn or the Company), a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of seriou

8-K · 2026-06-17 · 0001193125-26-273405

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ck0001540171-ex99_1.htm · 8-K · 2026-06-03

EX-99.1 2 ck0001540171-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Avalyn Reports First Quarter 2026 Financial Results and Recent Business Highlights On track to complete enrollment of MIST Phase 2b trial of AP01 in progressive pulmonary fibrosis (PPF) in mid-2026, with newly presented long term open-label extension clinical data that support favorable tolerability profile Enrollment underway in AURA Phase 2 trial of AP02 in patients with idiopathic pulmonary fibrosis (IPF) with topline data

8-K · 2026-06-03 · 0001193125-26-254581

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ck0001540171-ex4_1.htm · S-1 · 2026-04-08

EX-4.1 4 ck0001540171-ex4_1.htm EX-4.1 EX-4.1 Exhibit 4.1 ZQ|CERT#|COY|CLS|RGSTRY|ACCT#|TRANSTYPE|RUN#|TRANS# COMMON STOCK PAR VALUE $0.001 COMMON STOCK avalyn pharma Certificate Number ZQ00000000 THIS CERTIFIES THAT SEE REVERSE FOR CERTAIN DEFINITIONS CUSIP XXXXXX XX X Avalyn Pharma INCORPORATED UNDER THE LAWS OF THE STATE OF DELAWARE ** MR. Mr. Alexander David Sample SAMPLE **** Mr. Alexander & David Sample MRS. ** Mr. Alexander David MR. Sample **** Mr. Alexander SAMPLE David Sample ***

S-1 · 2026-04-08 · 0001193125-26-147573

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ck0001540171-ex4_2.htm · S-1 · 2026-04-08

EX-4.2 5 ck0001540171-ex4_2.htm EX-4.2 EX-4.2 Exhibit 4.2 Certain identified information has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”. AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT This Amended and Restated Investors’ Rights Agreement (this “Agreement”) is made as of April 25, 2025 b

S-1 · 2026-04-08 · 0001193125-26-147573

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ck0001540171-ex4_3.htm · S-1 · 2026-04-08

EX-4.3 6 ck0001540171-ex4_3.htm EX-4.3 EX-4.3 Exhibit 4.3 THIS WARRANT AND THE UNDERLYING SECURITIES ISSUABLE UPON EXERCISE OF THIS WARRANT HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, HYPOTHECATED, OR OTHERWISE TRANSFERRED EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY THAT REGISTRATION IS NOT REQUI

S-1 · 2026-04-08 · 0001193125-26-147573

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