Savara Inc. has recently released its 10-Q report, providing insight into the company's financial condition and results of operations. The clinical-stage biopharmaceutical company is focused on rare respiratory diseases, with its lead product candidate, molgramostim, in Phase 3 development for the treatment of autoimmune pulmonary alveolar proteinosis. The company was founded in 2007 and is headquartered in Langhorne, Pennsylvania.
In the report, Savara Inc. stated that it had received a Refusal to File (RTF) letter from the FDA for the Biologics License Application (BLA) of MOLBREEVI as a therapy for autoimmune PAP. The company plans to resubmit the BLA in December 2025 and request Priority Review. As of June 30, 2025, the company had cash and cash equivalents of $17.4 million and short-term investments of $129.0 million. Savara Inc. acknowledged that it will require additional capital to continue its clinical development and potential commercialization activities, and may need to raise further capital to fund the development of its product candidate.
The 10-Q report also provided a detailed overview of the company's financial operations. For the three months ended June 30, 2025, Savara Inc. reported a net loss of $30.4 million, compared to a net loss of $22.2 million for the same period in 2024. Research and development expenses for the three months ended June 30, 2025, increased by $3.1 million to $20.8 million, primarily due to costs related to the MOLBREEVI program. General and administrative expenses also increased by $5.1 million to $10.7 million for the same period, mainly attributable to the strategic addition of personnel and related costs.
For the six months ended June 30, 2025, the company reported a net loss of $57.0 million, compared to a net loss of $42.6 million for the same period in 2024. Research and development expenses increased by $5.5 million to $39.9 million, primarily due to costs related to the MOLBREEVI program. General and administrative expenses also increased by $8.7 million to $19.9 million for the same period, mainly due to the strategic addition of personnel and related costs.
Savara Inc. emphasized the need for additional capital to fund its planned activities, stating that the amount and timing of its future funding requirements will depend on various factors, including the pace and results of its clinical development efforts. Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on the company's financial condition and its ability to develop its product candidate. Today the company's shares have moved 4.46% to a price of $2.695. Check out the company's full 10-Q submission here.
