Savara Inc. Reports $95.9 Million Net Loss for Fiscal Year 2024 Amid Increased R&D Expenses

Savara Inc., a clinical-stage biopharmaceutical company focused on rare respiratory diseases, reported a net loss of $95.9 million for the fiscal year ending December 31, 2024, compared to a loss of $54.7 million in the previous year. The company's total operating expenses increased to $103.2 million from $60.0 million, primarily driven by a 76.3% rise in research and development costs, which reached $78.0 million. This increase was largely attributed to activities related to the development of its sole product candidate, MOLBREEVI, an inhaled biologic for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). General and administrative expenses also rose by 59.8% to $25.0 million, reflecting higher personnel costs and commercial activities.

Savara's financial position remains robust, with cash, cash equivalents, and short-term investments totaling approximately $196.3 million as of December 31, 2024. The company has raised approximately $594.9 million since its inception, primarily through equity offerings and debt financing. In March 2025, Savara completed a $30 million draw under a new loan agreement with Hercules Capital, which allows for additional funding contingent on regulatory approval of MOLBREEVI. The company anticipates that it will continue to incur significant operating losses as it advances its clinical development programs.

Strategically, Savara has made significant progress with MOLBREEVI, having completed patient enrollment in the Phase 3 IMPALA-2 trial, which exceeded its target by enrolling 164 patients. The trial reported positive top-line results in June 2024, demonstrating significant improvements in lung function and clinical benefits. Following these results, Savara initiated a rolling submission of a Biologics License Application (BLA) to the FDA, which was completed on March 26, 2025. The company has also established partnerships with contract manufacturers to ensure a reliable supply chain for MOLBREEVI.

Operationally, Savara has focused on outsourcing its manufacturing and clinical development activities, which has allowed it to manage costs effectively. As of March 27, 2025, the company employed 59 individuals, with no employees represented by labor unions. The company has also launched the Savara Early Access Program for MOLBREEVI, enabling physicians to request the product for eligible patients in regions where it is not yet commercially available. Looking ahead, Savara's ability to achieve profitability will depend on the successful commercialization of MOLBREEVI and the extent to which it can navigate the regulatory landscape and market acceptance challenges.