LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has announced its financial results for the first quarter ending March 31, 2025, alongside significant business updates, including the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a treatment for autoimmune pulmonary alveolar proteinosis (autoimmune PAP).
Savara confirmed it has requested priority review with the FDA for MOLBREEVI, which, if granted, could lead to a Prescription Drug User Fee Act (PDUFA) decision by year’s end. The company also remains on track to file a Marketing Authorization Application (MAA) for MOLBREEVI in Europe and the U.K. by late 2025, preparing for a potential U.S. launch in early 2026.
“With the timely submission of the MOLBREEVI BLA and the financial foundation to support a U.S. launch, we are well-positioned for future growth,” said Matt Pauls, Savara’s Chair and CEO. “We anticipate significant milestones ahead, including a targeted PDUFA date and advancing our European and U.K. regulatory submissions.”
Financial Highlights
Savara reported a cash and short-term investment balance of approximately $172.5 million as of March 31, 2025, and completed a $200 million non-dilutive debt financing in March, including $30 million used to refinance existing debt. The company believes its current funding will sustain operations into the second half of 2027, beyond the anticipated U.S. launch of MOLBREEVI.
For the quarter, the company posted a net loss of $26.6 million ($(0.12) per share) compared to a net loss of $20.3 million ($(0.11) per share) in Q1 2024. Research and development expenses rose by 14%, reaching $19.2 million, primarily due to regulatory efforts for the MOLBREEVI program. General and administrative expenses also increased to $9.2 million, driven by personnel costs and preparatory commercial activities.
Outlook
Savara’s progress underscores its strategic focus on regulatory achievements and commercial readiness for MOLBREEVI. With significant milestones, a strong cash position, and continued investment in innovation, the company is poised for future success in addressing the unmet needs of patients with autoimmune PAP and beyond.
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