Savara Presented New Biomarker Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society (ATS) International Conference 2026

Key Terms

autoimmune pulmonary alveolar proteinosis medical

A rare lung disease in which the tiny air sacs that exchange oxygen become filled with excess protein and fat, like a sponge clogged with foam so it can’t hold air properly. It matters to investors because it creates specific needs for diagnostics, treatments and long-term care; the rarity and complexity drive regulatory scrutiny, clinical trial risk and potential niche market opportunities for companies developing drugs or medical devices.

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A test that measures how well oxygen-like gases move from the air sacs in the lungs into the blood by using a tiny, harmless amount of carbon monoxide as a tracer. Think of it as checking how efficiently a sponge soaks up water — the higher the number, the better the lungs move gas into circulation. Investors care because this measurement is a common clinical benchmark for respiratory drugs, devices and therapies; it can influence trial outcomes, regulatory approval and the commercial potential of products aimed at lung disease.

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A mucus-related protein released by damaged lung cells that is measured in blood as a biomarker for lung injury and scarring; clinicians use its level to help detect and monitor interstitial lung disease and other pulmonary conditions. For investors, KL-6 acts like a smoke alarm signal for lung damage: changes in its use or test demand can drive sales of diagnostic kits, influence clinical trial outcomes, and affect the outlook for companies making tests or treatments for lung disease.

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Cytokeratin 19 fragments are small pieces of a structural protein released into the blood when certain epithelial cells break down, often because of tumor activity. Investors care because levels measured by blood tests can help detect, track, or judge response to treatment for some cancers—think of it like a dashboard warning light that signals disease activity and can influence the commercial value of diagnostic tests, drugs, and monitoring services.

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A carcinoembryonic antigen (CEA) is a protein that can appear at higher levels in the blood when certain tumors are present or active; clinicians use its measurement as a biomarker to monitor cancer treatment and check for recurrence. Think of it like a dashboard warning light — a rising level can signal a problem that deserves further investigation but is not a definitive diagnosis on its own. For investors, CEA trends matter because they can influence clinical trial outcomes, regulatory decisions, and demand for related diagnostics or therapies.

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Lactate dehydrogenase (LDH) is a common enzyme found in many tissues that is released into the bloodstream when cells are damaged or stressed. Investors watch LDH because rises or falls can act like a car’s warning light — signaling tissue injury, infection, or tumor activity — and therefore influence clinical trial results, drug safety assessments, diagnostic product demand, and the perceived value of healthcare companies.

granulocyte-macrophage colony-stimulating factor medical

A naturally occurring protein that acts like a fertilizer for the immune system, signaling the body to make and activate key white blood cells (granulocytes and macrophages). It matters to investors because medicines or treatments that use or target this protein can affect clinical trial outcomes, regulatory approval prospects, manufacturing needs and safety profiles—factors that can materially influence a biotech or pharmaceutical company’s value.

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An eflow nebulizer system is a branded medical device that converts liquid respiratory medication into a fine mist so patients can inhale it into their lungs; think of it as a high-tech spray bottle designed for precise, consistent delivery of inhaled drugs. Investors care because such devices can drive steady product sales, depend on regulatory approvals and insurance reimbursement, and influence how widely a respiratory therapy is adopted — factors that affect revenue, margins and long-term market potential.

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LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented a poster at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The poster reported new biomarker data from the double-blind period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of aPAP.

Below is a summary of the poster presented.

Poster Board 401: “Relationship Between Pulmonary Gas Transfer and Biomarker Levels in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP),” presented by Y. Inoue, M.D.; sponsored by Savara Inc.

• Presented serum biomarker data from IMPALA-2, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial in which aPAP patients received nebulized molgramostim 300 µg (n=81) or placebo (n=83) once daily for 48 weeks. Blood samples were collected at baseline and at Weeks 4, 12, 24, and 48, measuring levels of Krebs von den Lungren protein-6 (KL-6), cytokeratin 19 fragments (CYFRA 21-1), carcinoembryonic antigen (CEA), lactate dehydrogenase (LDH), hemoglobin, and hematocrit. At baseline, all biomarker levels were similar between the molgramostim and placebo groups.

• Molgramostim significantly improved pulmonary gas transfer, as measured by change from baseline in percent predicted diffusing capacity of the lungs for carbon monoxide adjusted for hemoglobin (DLco%) at Week 24 (P=0.0007) and Week 48 (P=0.0008) versus placebo. Post-hoc analyses showed that patients in the molgramostim group also demonstrated significantly greater mean decreases from baseline in LDH (Week 24, P=0.0150; Week 48, P=0.0051), CYFRA 21-1 (Week 24, P=0.0036; Week 48, P=0.0017), and KL-6 (Week 24, P=0.0016; Week 48, P=0.0022) compared with placebo. Mean changes from baseline in hemoglobin, hematocrit, and CEA at Weeks 24 and 48 were similar between the treatment groups.

• Strong correlations were observed in the overall study population (pooled treatment groups) between improvements in DLco% and decreases in LDH (Week 24, r=−0.5154; Week 48, r=−0.6266), CYFRA 21-1 (Week 24, r=−0.6414; Week 48, r=−0.6908), and KL-6 (Week 24, r=−0.7286; Week 48, r=−0.6864), all P<0.0001.

• Conclusions: Biomarker levels associated with aPAP disease severity decreased in patients treated with molgramostim. Additionally, decreased levels of biomarkers were associated with improvements in pulmonary gas transfer.

The full content of this poster will be available on the Congresses and Publications page of the Savara corporate website. The abstract is published in a supplement of the American Journal of Respiratory and Critical Care Medicine (AJRCCM). For more details about the ATS International Conference, please visit https://conference.thoracic.org/index.php.

About aPAP

Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim) is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via a proprietary investigational eFlow^® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of molgramostim. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260520792505/en/

Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com

Source: Savara Inc.