Savara to Present New Data from Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the European Respiratory Society (ERS) Congress 2024

Rhea-AI Summary

Savara Inc. (Nasdaq: SVRA) announced the acceptance of an abstract for poster presentation at the European Respiratory Society (ERS) Congress 2024, taking place September 7-11, 2024, in Vienna, Austria. The abstract, titled "Inhaled Molgramostim Improves Pulmonary Gas Exchange and Respiratory Health-Related Quality of Life (HRQoL) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from IMPALA-2", will be presented on September 8, 2024.

Additionally, Savara is sponsoring an Industry Symposium titled "Pulmonary Alveolar Proteinosis: Pathophysiology, Diagnosis, and Management" on the same day. The symposium will feature speakers Cormac McCarthy, Elisabeth Bendstrup, and Francesco Bonella, all holding M.D. and Ph.D. degrees.

Positive

• Acceptance of abstract for poster presentation at a major respiratory conference
• Sponsorship of an Industry Symposium at the ERS Congress
• Presentation of results from the pivotal Phase 3 IMPALA-2 trial

Negative

• None.

Company-Sponsored Industry Symposium To Be Held at the ERS Congress

LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the acceptance of an abstract for poster presentation at the European Respiratory Society (ERS) Congress 2024, taking place September 7-11, 2024, in Vienna, Austria. The Company is also sponsoring an Industry Symposium at the Congress. Details are as follows:

Accepted Abstract
Title: “Inhaled Molgramostim Improves Pulmonary Gas Exchange and Respiratory Health-Related Quality of Life (HRQoL) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from IMPALA-2”
Poster Session PS-29: Deep in Clinical Dilemmas of Non-Idiopathic Interstitial Lung Diseases
Date and Time: September 8, 2024, 12:30-14:00 CET

Company-Sponsored Symposium
Title: “Pulmonary Alveolar Proteinosis: Pathophysiology, Diagnosis, and Management”
Location: ERS Congress Industry Theater
Date and Time: September 8, 2024, 17:30 – 19:00 CET
Speakers: Cormac McCarthy, M.D., Ph.D., FRCPI, Elisabeth Bendstrup, M.D., Ph.D., and Francesco Bonella, M.D., Ph.D.

About aPAP

Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli (or air sacs) of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the inside of the alveoli to prevent the alveoli from collapsing. In a healthy lung, the old and inactivated 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 autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering the macrophages unable to adequately clear surfactant. The resulting excess surfactant accumulates in the alveoli, creating a barrier to gas exchange, and manifesting clinically as 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 nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow^® Nebulizer System (PARI Pharma GmbH). 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. (X, formerly known as Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).

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 risks and uncertainties related to the impact of widespread health concerns or changing economic or geopolitical conditions; 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/20240815629806/en/

Savara Inc. IR & PR

Anne Erickson (anne.erickson@savarapharma.com)

(512) 851-1366

Source: Savara Inc.

FAQ

What are the key findings from Savara's IMPALA-2 trial for molgramostim in aPAP patients?

The IMPALA-2 trial results show that inhaled molgramostim improves pulmonary gas exchange and respiratory health-related quality of life in patients with autoimmune pulmonary alveolar proteinosis (aPAP).

When and where will Savara (SVRA) present the IMPALA-2 trial results?

Savara will present the IMPALA-2 trial results at the European Respiratory Society (ERS) Congress 2024, taking place September 7-11, 2024, in Vienna, Austria. The poster presentation is scheduled for September 8, 2024.

What is the topic of Savara's sponsored symposium at the ERS Congress 2024?

Savara is sponsoring a symposium titled "Pulmonary Alveolar Proteinosis: Pathophysiology, Diagnosis, and Management" at the ERS Congress 2024 on September 8, 2024.

Who are the speakers at Savara's sponsored symposium during the ERS Congress 2024?

The speakers at Savara's sponsored symposium are Cormac McCarthy, M.D., Ph.D., FRCPI, Elisabeth Bendstrup, M.D., Ph.D., and Francesco Bonella, M.D., Ph.D.