Press release
Savara Reports First Quarter 2025 Financial Results and Provides a Business Update
-- Completed Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for
About this update from Savara, Inc.
[{"type":"text","content":"\n-- Completed Submission of the 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) and Requested Priority Review --\n\n-- Company Remains on Track to Submit the MOLBREEVI Marketing Authorization Application (MAA) for Autoimmune PAP to the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) by End of the Year --\n\n-- Entered into a Non-Dilutive Debt Financing in March for up to $200M Which Included $30M at Close to Refinance Existing Debt Facility --\n\n-- Reported ~$172.5M in Cash and Short-Term Investments as of March 31, 2025, Company Believes it is Sufficiently Capitalized into 2H 2027 --\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 first quarter ending March 31, 2025 and provided a business update.\n\n“At the end of 1Q 2025, we announced the on-time submission of the MOLBREEVI BLA to the FDA for the treatment of autoimmune PAP and requested priority review,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “If Priority Review is granted, we anticipate a PDUFA date by the end of the year and are preparing for a U.S. commercial launch in early 2026. We are also on track to submit the MAA in both Europe and the U.K. by the end of the year. Lastly, with approximately $172.5 million in cash, and the optionality to further finance the company through access to low-cost capital from our recent debt financing, we are in a strong financial position and believe our current cash runway extends into 2H 2027, well beyond a U.S. launch.”\n\nUpcoming Presentations at American Thoracic Society (ATS) Conference\n\nNew data from the Phase 3 IMPALA-2 trial of MOLBREEVI in patients with autoimmune PAP will be presented at the ATS International Conference 2025 in San Francisco, May 16-21, 2025. The Company is also hosting an Industry Symposium with leading key opinion leaders in autoimmune PAP. For more information see our recent press release.\n\nFirst Quarter Financial Results (Unaudited)\n\nSavara's net loss for the first quarter of 2025 was $26.6 million, or $(0.12) per share, compared with a net loss of $20.3 ...