LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has announced its financial results for the fourth quarter and fiscal year 2024, alongside key updates on its MOLBREEVI program, which aims to address a rare lung disease known as autoimmune pulmonary alveolar proteinosis (aPAP).
The company marked a significant milestone with the completion of its Biologics License Application (BLA) submission for MOLBREEVI to the U.S. Food and Drug Administration (FDA). “Completing submission of the BLA is an important milestone in potentially addressing the significant unmet need of people living with aPAP, a rare and debilitating lung disease,” said Matt Pauls, Chair and Chief Executive Officer of Savara. “MOLBREEVI has the potential to be the first and only approved therapy for aPAP in the U.S. and Europe and could redefine the standard of care for the disease.”
Financial Highlights
Savara’s net loss for Q4 2024 was $29.0 million, or $(0.13) per share, compared to a net loss of $16.1 million, or $(0.09) per share, in Q4 2023. For the full year 2024, the net loss totaled $95.9 million, up from $54.7 million in 2023.
The company invested heavily in research and development in 2024, with R&D expenses increasing by 76.3% year-over-year to $78.0 million. Much of this spending was tied to the advancement of MOLBREEVI, including $19.9 million in manufacturing initiatives, $2.8 million for the IMPALA-2 and other trials, and $4.1 million in regulatory and quality assurance activities.
General and administrative expenses also rose, totaling $25.0 million for 2024, an increase of nearly 60% from the previous year, driven by personnel costs, commercial preparations, and patient advocacy initiatives.
Despite these increases in operating costs, Savara maintained a strong financial position with $196.3 million in cash, cash equivalents, and short-term investments at the end of 2024. This cash reserves are expected to support the company’s operations through the second quarter of 2027, excluding a recently secured $200 million loan agreement with Hercules Capital.
Regulatory Progress for MOLBREEVI
MOLBREEVI has the potential to become the first approved treatment for aPAP, targeting a critical unmet medical need. The drug has received numerous regulatory designations, including Orphan Drug, Fast Track, and Breakthrough Therapy by the FDA, as well as Orphan Drug Designation by the European Medicines Agency (EMA). The company is also pursuing Priority Review status, which could lead to a U.S. approval decision by the end of 2025.
Savara is preparing for a potential early 2026 U.S. commercial launch of MOLBREEVI while planning to file a Marketing Authorization Application in Europe later this year.
“Savara is in a strong financial position as we prepare for key milestones, including the potential approval and launch of MOLBREEVI,” Pauls noted.
Looking Ahead
With regulatory reviews underway and a robust cash position, Savara is well-positioned to advance its mission of addressing rare lung diseases. The company’s financial commitment to advancing MOLBREEVI underlines its determination to make a lasting impact in the healthcare landscape for underserved patient populations.
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