Savara Announces the Rare Lung Disease, Autoimmune Pulmonary Alveolar Proteinosis (aPAP), is Highlighted on a New Episode of “The Balancing Act®” Airing on Lifetime® TV

Rhea-AI Summary

Savara Inc. (Nasdaq: SVRA) announced that a new episode of The Balancing Act® on Lifetime TV's Behind the Mystery™ series is featuring autoimmune Pulmonary Alveolar Proteinosis (aPAP). The episode, sponsored by Savara, focuses on an aPAP patient's diagnostic journey and includes insights from Dr. Bruce Trapnell, the International Coordinating Investigator for Savara's IMPALA-2 Phase 3 clinical trial of molgramostim inhalation solution in aPAP.

The episode aims to educate viewers about aPAP's symptoms and diagnosis, highlighting the lack of approved treatments in the US and Europe. Savara's CEO, Matt Pauls, emphasized the company's commitment to the aPAP community and their goal of providing an effective therapy. Savara expects to complete submission of the Biologics License Application (BLA) for molgramostim in aPAP with the FDA in the first half of 2025.

Positive

• Increased awareness for aPAP through a television feature, potentially expanding Savara's market reach
• Progress in the development of molgramostim for aPAP, with BLA submission expected in 1H 2025
• Positioning as a leader in addressing an unmet medical need in a rare respiratory disease

Negative

• No currently approved medicines for aPAP in the United States or Europe, indicating potential regulatory challenges
• BLA submission not expected until 1H 2025, suggesting a long timeline before potential revenue generation

LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced that a new episode of The Balancing Act^®, sponsored by Savara and featuring autoimmune Pulmonary Alveolar Proteinosis (aPAP), is airing on Lifetime TV’s Behind the Mystery™ a recurring series on The Balancing Act^® television show devoted to advocating for people with rare and genetic diseases. The episode centers on the diagnostic journey of an aPAP patient and includes insights from Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine and the International Coordinating Investigator for Savara’s IMPALA-2 Phase 3 clinical trial of molgramostim inhalation solution (molgramostim) in aPAP.

The episode provides a look into the real-life story of an aPAP patient—highlighting his journey to diagnosis, disease management, and need for improved treatment options. A replay of the episode can be viewed at https://bit.ly/480OPyy.

“We are pleased to partner with The Balancing Act to highlight aPAP, a rare respiratory disease with no currently approved medicines in the United States or Europe and a high unmet need for patients,” said Matt Pauls, Chair and CEO, Savara. “Educating people about the hallmark signs and symptoms of aPAP, as well as the simple, accurate, non-invasive blood test to help diagnose the disease, may increase awareness for this debilitating condition and provide a quicker path to diagnosis for patients. We are committed to the global aPAP community and continue to work towards our goal of potentially providing an effective therapy for patients.”

The Company expects to complete submission of the Biologics License Application (BLA) for molgramostim in aPAP with the U.S. Food and Drug Administration (FDA) in 1H 2025.

About aPAP

Autoimmune PAP (aPAP) 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 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 autoimmune PAP, 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 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/).

About Behind the Mystery™

Behind the Mystery™ is a recurring series on The Balancing Act^® television show devoted to advocating for rare and genetic diseases. The series clarifies the often-complex issues by offering easy-to-understand explanations from top experts in the field through partnerships with foundations and pharmaceutical companies. We amplify the voices of patients, families, and advocates affected by rare diseases via our national television platform. Tune in to Behind the Mystery weekdays at 7:30 a.m. (ET/PT) on Lifetime^® and find all previously aired episodes on TheBalancingAct.com/rare.

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, but are not limited to, statements regarding education potentially leading to increased awareness of aPAP and a quicker path to diagnosis, Savara’s goal of potentially providing an effective therapy, and the anticipated timing of Savara’s BLA submission. 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 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/20241022563937/en/

Savara Inc. IR & PR

Anne Erickson (anne.erickson@savarapharma.com)

(512) 851-1366

Source: Savara Inc.

FAQ

What is the focus of Savara's IMPALA-2 Phase 3 clinical trial?

Savara's IMPALA-2 Phase 3 clinical trial is focused on testing molgramostim inhalation solution for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP).

When does Savara (SVRA) expect to submit the BLA for molgramostim in aPAP?

Savara expects to complete the submission of the Biologics License Application (BLA) for molgramostim in aPAP to the FDA in the first half of 2025.

What rare lung disease is featured in the new episode of 'The Balancing Act' sponsored by Savara (SVRA)?

The new episode of 'The Balancing Act' sponsored by Savara features autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease.

Who is the International Coordinating Investigator for Savara's (SVRA) IMPALA-2 Phase 3 clinical trial?

Dr. Bruce Trapnell, Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine, is the International Coordinating Investigator for Savara's IMPALA-2 Phase 3 clinical trial.