Press release
Savara Reports Third Quarter 2025 Financial Results and Provides Business Update
-- On Track to Resubmit the Biologics License Application (BLA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) in December and
About this update from Savara, Inc.
[{"type":"text","content":"\n-- On Track to Resubmit the Biologics License Application (BLA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) in December and Will Request Priority Review --\n\n\n-- Expect to Submit the MOLBREEVI Marketing Authorization Applications (MAA) for Autoimmune PAP to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 1Q 2026 --\n\n\n-- Recently Strengthened Balance Sheet with ~$149.5M Equity Financing, Which Added ~$140M to the ~$124M in Cash, Cash Equivalents, and Short-Term Investments Reported as of September 30, 2025, and Announced $75M Royalty Funding Agreement to Support Potential MOLBREEVI Launch --\n\n\n LANGHORNE, Pa.--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2025.\n\n\n“Our recent strategic financings further strengthen our balance sheet, significantly increase our cash runway, and allow us to accelerate our investment in preparing for the potential commercialization of MOLBREEVI,” said Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer, Savara. “We remain on track to resubmit the MOLBREEVI BLA in December as well as submit the MAAs for MOLBREEVI in Europe and the UK in the first quarter of 2026.”\n\n\nPauls continued, “At this year’s European Respiratory Society meeting we presented new data analyses from the pivotal IMPALA-2 trial that further support the efficacy of MOLBREEVI for the treatment of autoimmune PAP. Given that there are no approved therapies for autoimmune PAP in the U.S. or Europe, we are steadfast in our goal to bring the first and only pharmacologic treatment for autoimmune PAP to market and are confident that MOLBREEVI could fundamentally change the way this rare and chronic lung disease is treated.”\n\n\nThird Quarter Financial Results (Unaudited)\n\n\nSavara's net loss for the third quarter of 2025 was $29.6 million, or $(0.14) per share, compared with a net loss of $24.2 million, or $(0.11) per share, for the third quarter of 2024.\n\n\nResearch and development expenses increased by $0.3 million, or 1.4%, to $20.6 million for the three months ended September 30, 2025 from $20.3 million for the three months ended September 30, 2024. This...