Savara Announces Q1 2024 Financial Results and Business Update

Savara Inc., a clinical-stage biopharmaceutical firm specializing in rare respiratory diseases, has announced its financial outcomes for the first quarter ending March 31, 2024, along with a business update. The company's principal project, the Pivotal Phase 3 IMPALA-2 trial, is progressing as planned, with top-line results expected by the end of the second quarter of 2024.

The 48-week placebo-controlled IMPALA-2 trial is evaluating molgramostim nebulizer solution, a novel inhaled biologic, for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease. Depending on the results, Savara anticipates filing a Biologics License Application (BLA) in the first half of 2025. The company is confident that with its current capital of approximately $143 million in cash and short-term investments, it is funded adequately until 2026.

Matt Pauls, Chair and CEO of Savara, stated, "The IMPALA-2 trial remains on track, and we look forward to reporting top-line results by the end of the second quarter. Assuming positive data, we plan to file a BLA in the first half of 2025. With $143 million in cash and investments, we believe we are capitalized into 2026, which covers not only the data read-out but also additional investments in extending the IMPALA-2 open-label period, launching a global Expanded Access program for molgramostim, building U.S. Commercial infrastructure, and making pre-Commercial preparations in Europe."

In the first quarter of 2024, Savara reported a net loss of $20.3 million, or $(0.11) per share, compared to a net loss of $10.6 million, or $(0.07) per share, for the same period in 2023. Research and development (R&D) expenses saw a notable increase of $8.1 million, or 92.3%, to $16.8 million from $8.7 million in the first quarter of 2023. This rise was mainly due to the molgramostim program, which included $4.3 million associated with chemistry, manufacturing, and controls activities. Other significant R&D costs included $1.0 million related to the IMPALA-2 clinical trial, $0.6 million for regulatory affairs and quality assurance, and a $2.2 million increase in personnel and related costs.

General and administrative expenses also rose by $2.3 million, or 67.4%, to $5.6 million for the first quarter of 2024, compared to $3.4 million for the same period in 2023. This increase was due to personnel and related costs of $0.6 million, $1.1 million for certain commercial activities, and $0.6 million for other overhead expenses, primarily driven by patient advocacy activities.

As of March 31, 2024, Savara had cash, cash equivalents, and short-term investments totaling approximately $143 million and debt of around $26.4 million.

Savara is dedicated to addressing rare respiratory diseases, with a particular focus on its lead program, molgramostim nebulizer solution. This therapy is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for treating aPAP. Molgramostim is administered through an investigational eFlow® Nebulizer System from PARI Pharma GmbH. The management team at Savara boasts extensive experience in rare respiratory diseases and pulmonary medicine, enabling them to identify unmet needs and effectively advance product candidates toward approval and commercialization.