A clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2025 and provided a business update.
“Over the last year, we significantly advanced the MOLBREEVI development program,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “With the filing of the BLA, an assigned PDUFA date of August 22nd, and submission of the MAAs we have strong momentum. U.S. commercial planning is underway, most notably with the onboarding of a market development team that will be complete in the second quarter. With approximately $236 million in cash and access to up to an additional $150 million in non-dilutive capital through debt and royalty structures upon MOLBREEVI approval, we can fund global commercial launch activities. Strong financial flexibility combined with meaningful near-term catalysts means we enter 2026 in a position of strength and confidence.”
In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s MHRA.
Fourth Quarter Financial Results (Unaudited)
Savara’s net loss for the fourth quarter of 2025 was $32.2 million, or $(0.13) per share, compared with a net loss of $29.0 million, or $(0.13) per share, for the fourth quarter of 2024.
Research and development expenses for the fourth quarter of 2025 and 2024 were $20.9 million and $23.3 million, respectively.
General and administrative expenses for the fourth quarter of 2025 and 2024 were $12.5 million and $7.8 million, respectively.
As of December 31, 2025, the Company had cash, cash equivalents and short-term investments of $235.7 million.
Fiscal Year 2025 Financial Results
The Company’s net loss for the year ended December 31, 2025 was $118.8 million, or $(0.53) per share, compared with a net loss of was $95.9 million, or $(0.48) per share for the year ended December 31, 2024.
Research and development expenses increased $3.4 million, or 4.3%, to $81.4 million for the year ended December 31, 2025 from $78.0 million for the year ended December 31, 2024. This increase was primarily due to the performance of tasks related to our MOLBREEVI program, which includes $5.7 million of costs related to regulatory affairs and quality assurance, primarily driven by the BLA submission; $0.5 million of costs related to our chemistry, manufacturing, and controls activities; and $1.0 million other departmental overhead, partially offset by a decrease of $3.8 million in clinical costs.
General and administrative expenses increased $17.0 million, or 68.0%, to $42.1 million for the year ended December 31, 2025 from $25.0 million for the year ended December 31, 2024. The increase was due to higher personnel and related costs, in terms of compensation and an increase in valuation and stock awards, driven by strategic workforce expansion to support and scale operations of $11.2 million; certain additional commercial activities of $3.1 million; and other overhead of $2.7 million primarily driven by expanded patient advocacy and medical affairs activities.
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