Savara Announces New Exercise Capacity Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Key Terms

phase 3 medical

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

randomized medical

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

metabolic equivalents (mets) medical

Metabolic equivalents (METs) are a simple unit that compares how much energy the body uses during an activity to the energy used at rest; 1 MET equals the energy you burn while sitting quietly. Investors care because changes in METs are often used in clinical trials and regulatory filings to show whether a treatment or device meaningfully improves patients’ exercise capacity or daily functioning — think of METs as a speedometer that quantifies health improvement, which can affect market size, reimbursement, and adoption.

least-squares mean (lsm) technical

Least-squares mean (LSM) is an adjusted average calculated from a statistical model that estimates each group’s mean after accounting for other influencing factors like baseline differences or patient characteristics. Investors should care because LSMs are often used to report treatment effects or performance measures in clinical and financial analyses, and they can change the apparent size or significance of an outcome—similar to comparing test scores after correcting for different class sizes or starting skill levels.

95% confidence interval technical

A 95% confidence interval is a range around a measured number that is expected to contain the true value about 95 times out of 100 if the same measurement were repeated many times. Think of it like a weather forecast that gives a band of likely temperatures rather than a single number: the wider the band, the less precise the estimate. Investors use it to judge how much uncertainty surrounds reported figures or forecasts and to compare the reliability of different estimates.

p=0.0262 technical

p=0.0262 is a statistical result indicating there is about a 2.62% chance of observing the reported data (or something more extreme) if there were actually no real effect. For investors, a p-value this low is commonly treated as evidence that a finding is unlikely to be due to random chance, similar to flipping a coin many times and getting an unexpectedly lopsided run; it signals stronger evidence but does not guarantee practical importance or regulatory approval.

-- Data Were Presented in an Oral Presentation at the American Thoracic Society (ATS) International Conference 2026 --

LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, sponsored an oral presentation at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The presentation reported new exercise capacity 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 data presented.

Oral Presentation, Abstract 9296: “Molgramostim Improves Exercise Distance and Duration in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from the IMPALA-2 Phase 3 Clinical Trial,” presented by B.C. Trapnell, M.D.; sponsored by Savara Inc.

• Presented exercise capacity data from IMPALA-2, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial in which adults with aPAP received nebulized molgramostim 300 µg (n=81) or placebo (n=83) once daily for 48 weeks. IMPALA-2 achieved statistical significance on its primary endpoint and other secondary endpoints, including a greater mean improvement in exercise capacity, expressed as peak metabolic equivalents (METs), in the molgramostim group at 48 weeks. This oral presentation reported on the effects of molgramostim on exploratory endpoints of exercise distance and duration, assessed at Weeks 24 and 48 via a conservative, ramp-up, symptom-limited, exercise treadmill test.

• Greater mean improvement in distance walked was observed in molgramostim-treated patients compared with placebo at Week 48. The least-squares mean (LSM) change in distance walked from baseline to Week 48 was 167.0 m (95% confidence interval [CI], 112.1 to 221.8) in the molgramostim group and 86.4 m (95% CI, 32.4 to 140.4) in the placebo group, yielding an estimated treatment difference of 80.6 m (P=0.0301).

• Molgramostim patients were also able to exercise for longer periods of time compared with patients who received placebo. At Week 48, the LSM change in duration of exercise from baseline was 2.0 minutes (95% CI, 1.3 to 2.7) in the molgramostim group and 1.0 minute (95% CI, 0.3 to 1.6) in the placebo group, yielding an estimated treatment difference of 1.0 minute (P=0.0262).

• Consistent with improvements in peak METs, molgramostim improved both distance walked and duration of exercise at Week 48 compared with placebo, supporting the potential clinical benefit of molgramostim treatment in patients with aPAP.

"We believe the consistency in improvements observed across both exploratory endpoints—distance walked and exercise duration—and our secondary endpoint of exercise capacity, as measured by peak METs, strengthens the overall efficacy picture," said Yasmine Wasfi, M.D., Ph.D., Chief Medical Officer, Savara. "Taken together, these data suggest that molgramostim may translate into real-world functional benefits for aPAP patients."

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.

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. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. 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 as a result of 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; the actions and decisions of regulatory authorities; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue 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 to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260518925976/en/

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

Source: Savara Inc.