LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has released its financial results for the third quarter ending September 30, 2024, and provided an important business update that underscores the company’s strategic progress and financial performance.
Savara reported a net loss of $24.2 million, or $(0.11) per share, for the third quarter of 2024, compared to a loss of $16.6 million, or $(0.10) per share, in the same period last year. The increase in net loss is attributed to heightened research and development efforts, particularly those associated with their flagship MOLBREEVI program.
Research and development expenses rose by 46.5%, amounting to $20.3 million. This rise reflects significant investment in various aspects of the MOLBREEVI program, including $3.7 million in chemistry, manufacturing, and controls activities, and $0.2 million related to pediatric studies. Additional costs stemmed from regulatory and quality assurance activities and increased personnel expenses.
General and administrative expenses also saw a 45.0% increase to $6.0 million. This was primarily due to higher personnel costs and enhanced commercial activities.
Savara’s financial position remains robust with cash, cash equivalents, and short-term investments totaling approximately $219.4 million against a debt of $26.6 million as of the end of September 2024. The company believes this provides a cash runway extending into the second quarter of 2027.
On the regulatory front, Savara is advancing its MOLBREEVI program with significant milestones on the horizon. According to Matt Pauls, Chair and CEO of Savara, “After a productive pre-BLA meeting with the FDA, we are working diligently to initiate a rolling submission for MOLBREEVI by the end of this year, with plans to complete the BLA submission by the end of 1Q 2025—thus enabling a potential approval in the U.S. by the end of 2025, if priority review is granted.”
Pauls further emphasized the broader impact of these developments, stating, “BLA submission, coupled with the submission of the MAA to the EMA by the end of 2025, are major regulatory milestones that could bring us one step closer to providing aPAP patients in the U.S. and Europe with the first and only approved therapeutic option for this rare and debilitating lung disease.”
Savara is also enhancing its commercial capabilities to prepare for the potential market introduction of MOLBREEVI, aiming to ensure access for approximately 3,600 diagnosed aPAP patients in the U.S. upon approval. These strategic initiatives aim to address unmet needs in the clinical landscape and provide innovative solutions for rare diseases.
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