LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) reported second-quarter 2025 financial results and outlined key regulatory and business milestones, including plans to resubmit its Biologics License Application (BLA) for MOLBREEVI, a potential treatment for autoimmune pulmonary alveolar proteinosis (autoimmune PAP).
Following recent discussions with the U.S. Food and Drug Administration (FDA), Savara said it reached agreement on the information required to move forward with its application. The company plans to resubmit the BLA in December with FUJIFILM Biotechnologies as its drug substance manufacturer and will request priority review. Marketing authorization applications are also expected to be filed with the European Medicines Agency and the UK Medicines and Healthcare Products Regulatory Agency in the first quarter of 2026.
“With no approved therapies in the United States or Europe for autoimmune PAP, there is a high unmet medical need to treat this rare and debilitating lung disease,” said Matt Pauls, Savara’s Chair and CEO. “We are committed to our goal of providing these patients with the first and only pharmacologic treatment option.”
Financial Performance
Savara posted a net loss of $30.4 million, or $0.14 per share, for the second quarter, compared with a loss of $22.2 million, or $0.12 per share, in the same period last year.
Research and development expenses rose 17.8% year-over-year to $20.8 million, largely due to $3.3 million in Chemistry, Manufacturing, and Controls (CMC) work tied to establishing FUJIFILM as a second manufacturer, as well as $1.1 million in regulatory and quality assurance costs. These increases were partly offset by a $1.3 million reduction in clinical costs.
General and administrative expenses nearly doubled to $10.7 million from $5.5 million in the prior-year quarter, driven by higher personnel costs, commercial activities, and departmental overhead.
As of June 30, 2025, the company reported approximately $146.4 million in cash, cash equivalents, and short-term investments, with debt totaling $29.7 million. Savara said it is sufficiently capitalized into the first quarter of 2027.
Addressing a Rare Disease
Autoimmune PAP is a rare disorder in which antibodies neutralize granulocyte-macrophage colony-stimulating factor (GM-CSF), impairing the ability of immune cells to clear surfactant from the lungs. The resulting buildup can lead to shortness of breath, fatigue, and long-term complications such as fibrosis or the need for lung transplantation.
With regulatory submissions in the U.S. and Europe on the horizon, Savara is aiming to bring MOLBREEVI forward as the first pharmacologic treatment for the condition, a step that could reshape care for patients with limited therapeutic options.
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