Here are 1-3 brief analogies for Avalyn Pharma:

• Avalyn Pharma is like a 'Keurig' for pulmonary fibrosis drugs, transforming effective but problematic oral medications into safer, targeted inhaled versions.
• Avalyn Pharma is like a specialized GlaxoSmithKline or AstraZeneca for pulmonary fibrosis, bringing the next generation of inhaled therapies to patients, similar to how those companies revolutionized asthma treatment.
• Avalyn Pharma is like a 'Dyson' for respiratory drugs, redesigning existing effective oral therapies into optimized inhaled versions for dramatically better patient experience in pulmonary fibrosis.

• AP01: An inhaled formulation of pirfenidone being developed for the treatment of progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF).
• AP02: An inhaled formulation of nintedanib being developed for the treatment of idiopathic pulmonary fibrosis (IPF).
• AP03: A fixed-dose combination of inhaled pirfenidone and nintedanib designed to deliver dual antifibrotic mechanisms.

Avalyn Pharma (AVLN) is a clinical-stage biopharmaceutical company. As described in the background, the company is currently focused on developing and evaluating its product candidates (AP01, AP02, and AP03) in various phases of clinical trials. They do not yet have any approved or commercialized products on the market. Therefore, Avalyn Pharma does not currently have major customers or generate sales from products.

Lyn Baranowski, Chief Executive Officer

Ms. Baranowski brings over two decades of experience across biotech, big pharma, and venture capital, with a significant focus on immunology and respiratory therapeutic areas. Before joining Avalyn, she served as Chief Operating Officer at Altavant Sciences, a biopharmaceutical company that was acquired by Sumitomo Dainippon in 2019. She was also Vice President of Commercial Development at Pearl Therapeutics, which was sold to AstraZeneca for $1.15 billion in 2013. Her background also includes a role as Vice President at a healthcare-focused venture capital firm and senior positions in business development, marketing, and public affairs at Novartis Pharmaceuticals. Ms. Baranowski has a proven track record in capital formation, having raised nearly $750 million in private and public financings and leading multiple high-value M&A transactions.

Douglas Carlson, Chief Financial Officer and Chief Business Officer

Mr. Carlson has over 23 years of experience with a multi-disciplinary background in corporate finance, venture capital, M&A, business development, and commercial roles within both large and emerging growth biopharma companies. Prior to Avalyn, he was the CFO and COO of Avenge Bio, a clinical-stage biotech company. He also served as CFO and COO of Ikena Oncology (NASDAQ: IKNA), where he successfully led a $120 million Series B financing and a $144 million initial public offering (IPO). Earlier in his career, Mr. Carlson held senior positions at Collegium Pharmaceutical, BTG International (acquired by Boston Scientific), and Lundbeck, and was a healthcare private equity associate at Pequot Capital Management.

Melissa Rhodes, Ph.D., D.A.B.T., Chief Operating Officer

Dr. Rhodes has held leadership roles at various companies, including Kriya Therapeutics, Aerami Therapeutics, and Altavant, with a focus on the development of inhaled therapies.

Howard M. Lazarus, M.D., FCCP, Chief Medical Officer

Dr. Lazarus joined Avalyn Pharma in 2023. Previously, he was the Chief Medical Officer of Altavant Sciences (acquired by Enzyvant), where he was responsible for developing and implementing clinical development plans for candidates in pulmonary arterial hypertension (PAH) and bronchiolitis obliterans syndrome. He was also a key member of the clinical development and medical affairs team at Boehringer Ingelheim, working on the nintedanib idiopathic pulmonary fibrosis (IPF) program, and at Gilead Sciences, where he contributed to their IPF and PAH portfolios.

Adam Golden, J.D., General Counsel and Head of Business Development

Mr. Golden brings over 30 years of experience advising biopharma companies across legal, business development, and corporate strategy. Before joining Avalyn, he was a Partner and Global Head of Life Sciences at Freshfields LLP, where he founded and built out an internationally recognized life sciences practice. His previous roles include Partner and Head of the New York Corporate Practice Group at Hogan Lovells, and over two decades at Kaye Scholer, where he served as Partner and Co-Chair, Corporate Department. Mr. Golden has advised on mergers and acquisitions, strategic collaborations, corporate governance, and SEC compliance.

The key risks to Avalyn Pharma's business are primarily centered on the inherent challenges of biopharmaceutical development and market adoption.

1. Clinical Development and Regulatory Approval Risk: Avalyn Pharma is a clinical-stage company, and the success of its business is entirely dependent on the successful completion of its ongoing and planned clinical trials, including the global Phase 2b MIST trial for AP01, the global Phase 2 AURA trial for AP02, and the planned Phase 1 trial for AP03. There is a significant risk that these product candidates may fail to demonstrate sufficient efficacy or an improved tolerability profile in clinical trials, or encounter unexpected safety concerns. Furthermore, even with positive clinical data, there is no guarantee of obtaining regulatory approval from health authorities, which would prevent the commercialization of their therapies.
2. Commercialization and Market Acceptance Risk: Avalyn Pharma aims to address the limitations of current oral antifibrotic therapies by delivering optimized inhaled formulations directly to the lungs. However, even if successfully developed and approved, there is a risk that healthcare providers, prescribers, and patients may not adopt Avalyn's inhaled therapies as widely or as rapidly as anticipated. The market's perception of the benefit-risk profile of Avalyn's products may not align with the company's expectations, or the practicalities of an inhaled delivery method may present new challenges for patient adherence or preference, limiting commercial uptake.
3. Competition Risk: While Avalyn Pharma focuses on improving the delivery of established antifibrotic agents, it faces competition not only from the existing approved oral therapies (pirfenidone, nintedanib, and nerandomilast) but also from a pipeline of other investigational therapies for pulmonary fibrosis. These include therapies targeting novel biological pathways that could potentially offer different or perceived superior benefits, or be developed as add-on systemic treatments. Such competition could limit the market share and commercial potential of Avalyn's product candidates if they are successfully brought to market.

The addressable markets for Avalyn Pharma's main products are as follows:

• For Idiopathic Pulmonary Fibrosis (IPF), the U.S. market consists of approximately 120,000 people.
• For Progressive Pulmonary Fibrosis (PPF), the U.S. market consists of approximately 180,000 people.
• The global market for current oral antifibrotic therapies, which Avalyn Pharma's inhaled therapies aim to improve upon, generated more than $4.0 billion in gross global sales in 2024.

Here are 3-5 expected drivers of future revenue growth for Avalyn Pharma (AVLN) over the next 2-3 years:

1. Advancement and potential commercialization of AP01: Avalyn Pharma's lead candidate, AP01, an inhaled formulation of pirfenidone, is currently undergoing a global Phase 2b clinical trial (MIST) for the treatment of progressive pulmonary fibrosis (PPF). Successful progression through clinical trials and eventual market approval would enable Avalyn to capture a share of the PPF market, offering a therapy with a potentially improved tolerability profile compared to existing oral treatments.
2. Advancement and potential commercialization of AP02: AP02, an inhaled formulation of nintedanib, is being evaluated in AURA, a global Phase 2 clinical trial for idiopathic pulmonary fibrosis (IPF). Positive clinical trial results and subsequent regulatory approvals would allow Avalyn to enter the IPF market, addressing the significant unmet need for better-tolerated antifibrotic therapies and providing an alternative to current oral nintedanib.
3. Increased patient adherence and market penetration due to improved tolerability: Current oral antifibrotic therapies for pulmonary fibrosis are associated with high rates of gastrointestinal and other systemic side effects, leading to approximately 50% of patients discontinuing treatment within one year. Avalyn's inhaled approach aims to significantly reduce systemic exposure, thereby improving tolerability and patient adherence. This enhanced tolerability could lead to a substantial increase in the proportion of patients actively receiving antifibrotic therapy, expanding the overall addressable market and enabling Avalyn to capture a larger patient share compared to existing options.
4. Development and potential launch of AP03: Avalyn is advancing AP03, a fixed-dose combination of inhaled pirfenidone and nintedanib, into a Phase 1 clinical trial. If successful, AP03 could offer additive or synergistic benefits, providing a comprehensive, lung-targeted treatment with enhanced efficacy and convenience. The progression of this novel combination therapy through clinical development could represent a significant future revenue driver by establishing a new standard of care in the pulmonary fibrosis treatment paradigm.

Share Issuance

• Avalyn Pharma completed its initial public offering (IPO) on April 30, 2026, selling 16.67 million shares at $18.00 per share.
• The IPO generated gross proceeds of $300.06 million.
• Underwriters have an option to purchase an additional 2.5 million shares, which could raise an extra $45 million.

Inbound Investments

• The company entered 2026 with $138.4 million in cash, prior to its IPO.
• The IPO in April 2026 raised $300.06 million in gross proceeds, which Avalyn Pharma intends to use to fund late-stage studies of its inhaled respiratory drugs.

Outbound Investments

• Avalyn Pharma's Investments and Advances were reported as $0.00 million as of December 2025.

Capital Expenditures

• For the 12 months ending December 31, 2025, Avalyn Pharma reported depreciation and amortization of $42.00 thousand.