Core Insights - Savara Inc. reported significant advancements in the development of MOLBREEVI for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP), including the submission of Marketing Authorization Applications (MAAs) to the EMA and MHRA, and a Biologics License Application (BLA) to the FDA with a PDUFA date set for August 22, 2026 [1][1][1] Financial Results - For Q4 2025, Savara's net loss was $32.2 million, or $(0.13) per share, compared to a net loss of $29.0 million, or $(0.13) per share in Q4 2024 [1][1][1] - Research and development expenses for Q4 2025 were $20.9 million, down from $23.3 million in Q4 2024, while general and administrative expenses increased to $12.5 million from $7.8 million [1][1][1] - For the fiscal year 2025, the net loss was $118.8 million, or $(0.53) per share, compared to a net loss of $95.9 million, or $(0.48) per share in 2024 [1][1][1] - Research and development expenses for the year increased by $3.4 million, or 4.3%, to $81.4 million, primarily due to costs associated with the MOLBREEVI program [1][1][1] - General and administrative expenses rose by $17.0 million, or 68.0%, to $42.1 million, driven by higher personnel costs and strategic workforce expansion [1][1][1] Cash Position - As of December 31, 2025, Savara had approximately $236 million in cash and short-term investments, with access to an additional $150 million in non-dilutive capital upon FDA approval of MOLBREEVI [1][1][1] Regulatory Milestones - MOLBREEVI has received multiple designations, including Fast Track, Breakthrough Therapy, and Orphan Drug Designation from the FDA and EMA, as well as Innovation Passport and Promising Innovative Medicine designations from the UK's MHRA [1][1][1] Business Strategy - The company is preparing for U.S. commercial planning, including the onboarding of a market development team expected to be completed in Q2 2026 [1][1][1]