Savara Presented New Data Showing Molgramostim Inhalation Solution (Molgramostim) Treatment Effects in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Patients with Mild Diffusion Impairment

The subgroup findings are exploratory, with complete Week 24 data available for seven molgramostim-treated patients.

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-- 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/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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261021536120/en/

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

Source: Savara Inc.

Key Terms

dlco medical

DLCO is a medical test that measures how well gases move from the air in the lungs into the blood by using a small amount of carbon monoxide as a tracer; it quantifies the lung’s ability to transfer oxygen to the bloodstream. For investors, DLCO values are important because they help show whether respiratory drugs, devices or treatments improve or harm lung function—like testing how quickly water soaks through a sponge to judge its condition—which can affect clinical trial outcomes, regulatory decisions and market potential.

alveolar–arterial oxygen gradient medical

The alveolar–arterial oxygen gradient (A–a gradient) is the difference between the oxygen partial pressure in the alveoli (estimated from the inspired oxygen level using the alveolar gas equation) and the measured oxygen partial pressure in arterial blood (PaO2). It quantifies how effectively oxygen moves from the lungs into the blood and therefore helps identify problems such as ventilation–perfusion mismatch, diffusion impairment, or intrapulmonary shunting. The value depends on the fraction of inspired oxygen, barometric pressure and age, and must be interpreted alongside those factors and an arterial blood gas measurement.

st. george's respiratory questionnaire medical

A validated, disease-specific patient questionnaire that measures health-related quality of life in people with chronic respiratory conditions. It has three components—Symptoms (frequency/severity), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects)—and produces component scores and a total score on a 0–100 scale where higher scores indicate worse health status; scores are derived from patient responses using a prescribed scoring algorithm and are used in clinical studies and regulatory submissions to quantify treatment or disease effects. Limitation: it is a patient-reported outcome specific to respiratory disease (not a physiological test), so it reflects perceived symptoms and impairment rather than objective lung function; interpretation requires the instrument’s scoring rules and established thresholds for meaningful change.

ground-glass opacity medical

A ground-glass opacity is a hazy area seen on chest imaging (most commonly CT) where lung tissue looks denser than normal but blood vessels and airway walls remain partly visible; it reflects partial filling of airspaces or thickening of the lung interstitium rather than the complete solidification called consolidation. It is a nonspecific radiologic sign caused by various processes—such as infection, inflammation, edema, hemorrhage, or early fibrosis—and must be interpreted alongside clinical information and follow-up imaging because it does not by itself identify the exact cause.