Savara Inc. Reports $118.8 Million Net Loss for Fiscal Year 2025, Advances MOLBREEVI Program

Savara Inc., a clinical-stage biopharmaceutical company focused on rare respiratory diseases, reported a net loss of $118.8 million for the fiscal year ending December 31, 2025, compared to a net loss of $95.9 million in 2024. The company's total operating expenses increased to $123.5 million from $103.2 million in the previous year, driven primarily by a rise in general and administrative costs, which surged by 68% to $42.1 million. This increase was attributed to higher personnel costs and strategic workforce expansion to support operations. Research and development expenses also rose slightly to $81.4 million, reflecting ongoing efforts related to the development of its sole product candidate, MOLBREEVI, an inhaled biologic for autoimmune pulmonary alveolar proteinosis (autoimmune PAP).

Savara's financial position remains stable, with cash, cash equivalents, and short-term investments totaling approximately $235.7 million as of December 31, 2025. The company has raised approximately $738.1 million since its inception, primarily through equity offerings and debt financing. In October 2025, Savara completed an underwritten public offering that generated net proceeds of approximately $140.2 million, which will be used for clinical development and commercialization efforts. Additionally, the company entered into a loan agreement with Hercules Capital, allowing for up to $105 million in term loans, contingent upon regulatory approval of MOLBREEVI.

Strategically, Savara has made significant progress with its MOLBREEVI program, having submitted a Biologics License Application (BLA) to the FDA in December 2025, following a previous Refusal to File letter. The FDA formally filed the BLA in February 2026 and granted Priority Review status. MOLBREEVI has also received Fast Track and Breakthrough Therapy Designations from the FDA, as well as Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA). The company is currently conducting the Phase 3 IMPALA-2 trial, which has enrolled 164 patients, making it the largest placebo-controlled trial in autoimmune PAP.

Operationally, Savara has focused on establishing a robust supply chain for MOLBREEVI, partnering with contract manufacturers to ensure the production of clinical and commercial supplies. The company has also launched an Expanded Access Program for patients with autoimmune PAP, allowing physicians to request MOLBREEVI for eligible patients in select regions. As of March 2026, Savara employed approximately 70 individuals, with plans to expand its workforce to support commercialization efforts.

Looking ahead, Savara anticipates continued operating losses as it advances MOLBREEVI through clinical trials and regulatory processes. The company is actively seeking additional funding to support its operations and may explore partnerships to enhance its commercialization capabilities. The success of MOLBREEVI will depend on regulatory approvals, market acceptance, and the ability to navigate the competitive landscape of rare respiratory disease treatments.