Molgramostim inhalation(Savara Pharmaceuticals)

-- Post-Hoc Analysis of the Phase 2/3 IMPALA Clinical Trial Presented in a Poster Presentation at the CHEST 2026 Annual Meeting -- YARDLEY, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented a poster at the CHEST 2026 Annual Meeting in Phoenix, Arizona. The poster reports a post-hoc analysis of the IMPALA clinical trial evaluating the effects of molgramostim in aPAP patients with mildly decreased or normal diffusion capacity, defined as a baseline percent predicted hemoglobin-adjusted diffusing capacity of the lungs for carbon monoxide (DLco%) greater than 70%. Below is a summary of the data presented. Poster 4315: “Molgramostim Treatment Effects in Autoimmune Pulmonary Alveolar Proteinosis Patients with Mild Diffusion Impairment,” presented by B.C. Trapnell, M.D.; sponsored by Savara Inc. IMPALA was a randomized, double-blind, placebo-controlled Phase 2/3 clinical trial conducted at 34 clinical sites across 18 countries. The primary endpoint was change from baseline to Week 24 in alveolar–arterial oxygen gradient (A–aDO₂), a measure of pulmonary gas transfer. Of the 138 patients randomized, 13 (9%) had a baseline DLco% >70%. This analysis included the 8 patients randomized to once-daily molgramostim 300 µg and the 3 patients randomized to placebo. The 2 patients randomized to intermittent molgramostim (7 days every other week) were excluded since only the continuous once-daily regimen was carried forward into IMPALA-2. Seven molgramostim patients had complete Week 24 data. Their mean baseline DLco% was 81.9% (range, 72.1–97.5%). The 3 placebo patients had a mean baseline DLco% of 76.9% (range, 75.2–78.3%). Despite relatively preserved diffusing capacity, these patients had elevated alveolar–arterial oxygen gradient (A–aDO₂), indicating impaired gas transfer, impaired respiratory health-related quality of life (HRQoL), and a high surfactant burden at baseline. Pulmonary gas transfer improved in molgramostim-treated patients. Mean A–aDO₂ decreased from 32.5 mmHg at baseline to 19.8 mmHg at Week 24, a change of -12.7 mmHg. In placebo patients, mean A–aDO₂ decreased from 31.2 mmHg at baseline to 30.9 mmHg at Week 24, a change of -0.3 mmHg. Respiratory HRQoL improved with molgramostim (lower SGRQ scores indicate better HRQoL). Mean St. George's Respiratory Questionnaire SGRQ Total score (SGRQ-T) decreased in the molgramostim group from 30.5 points at baseline to 22.7 at Week 24, a change of -7.8 points. SGRQ-T decreased from 40.5 points at baseline to 33.4 at Week 24 in the placebo group, a change of -7.2 points. Mean SGRQ Activity score (SGRQ-A) decreased in the molgramostim group from 45.1 points at baseline to 34.0 at Week 24, a change of -11.1 points. In the placebo group, SGRQ-A decreased from 48.6 points at baseline to 46.3 at Week 24, a change of -2.3 points. Surfactant burden also decreased with molgramostim. Mean ground-glass opacity (GGO) score on chest computed tomography decreased in the molgramostim group from 8.7 points at baseline to 3.9 at Week 24, a change of -4.9 points. In placebo patients, mean GGO score increased from 7.0 points at baseline to 7.2 at Week 24, a change of 0.2 points. DLco% was maintained in molgramostim-treated patients, with no decline in diffusing capacity. This is expected in patients whose baseline diffusing capacity was already close to normal. Given the small number of patients meeting the DLco% >70% criterion, all findings are descriptive, exploratory, and hypothesis-generating. “In this analysis, patients with relatively preserved diffusing capacity enrolled in IMPALA still showed impaired gas transfer, substantial surfactant burden, and reduced quality of life at baseline,” said Bruce C. Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine. “Daily molgramostim was associated with improvements in each of these measures. While exploratory, these findings, together with the Phase 3 IMPALA-2 results, support the potential of molgramostim, if approved, to benefit patients with aPAP across the spectrum of disease severity.” 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 journal CHEST. For more details about the CHEST 2026 Annual Meeting, please visit https://www-chestnet-org.libproxy1.nus.edu.sg/learning-and-events/events/chest-annual-meeting. About the IMPALA Trial IMPALA was a global, randomized, double-blind, placebo-controlled Phase 2/3 clinical trial evaluating the efficacy and safety of inhaled molgramostim in patients with aPAP. The trial was conducted at 34 clinical sites across 18 countries. Patients were randomized 1:1:1 to receive molgramostim 300 µg once daily (continuous), molgramostim 300 µg once daily for 7 days every other week (intermittent), or matching placebo during a 24-week double-blind treatment period. This was followed by an open-label extension of up to 48 weeks. Results of the IMPALA trial were published in the New England Journal of Medicine in 2020. 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 transfer, 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. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include statements that while exploratory, these findings, together with the Phase 3 IMPALA-2 results, support the potential of molgramostim, if approved, to benefit patients with aPAP across the spectrum of disease severity. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements due to various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize molgramostim for aPAP; changes to applicable laws and regulations; the availability of sufficient resources for Savara’s operations and planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements, except as may be required by law. Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs ir@savarapharma.com