Savara Inc. Reports $30.4 Million Net Loss in Q2 2025, Increases R&D Spending for MOLBREEVI

Savara Inc. reported a net loss of $30.4 million for the second quarter of 2025, compared to a loss of $22.2 million in the same period of 2024, reflecting an increase of 37% year-over-year. For the first half of 2025, the company’s net loss reached $57.0 million, up from $42.6 million in the prior year. The increase in losses is attributed to higher operating expenses, which totaled $31.4 million for the quarter and $59.9 million for the six months, compared to $23.2 million and $45.7 million, respectively, in the same periods last year. The rise in expenses was primarily driven by increased research and development costs associated with the company's investigational inhaled biologic, MOLBREEVI, which is in development for autoimmune pulmonary alveolar proteinosis.

Savara's total assets decreased to $163.8 million as of June 30, 2025, down from $212.9 million at the end of 2024. This decline was largely due to a reduction in short-term investments, which fell from $181.2 million to $129.0 million. The company’s cash and cash equivalents increased slightly to $17.4 million from $15.1 million, while its accumulated deficit grew to approximately $546.3 million. The company has not generated any product revenue since its inception and continues to rely on capital raises to fund its operations.

In terms of strategic developments, Savara is focused on advancing its clinical program for MOLBREEVI. The company received a Refusal to File (RTF) letter from the FDA in May 2025 regarding its Biologics License Application (BLA) submission, which was not due to safety concerns but rather a request for additional data related to Chemistry, Manufacturing, and Controls. Savara plans to resubmit the BLA in December 2025 and is seeking Priority Review status. The company has also entered into a Hercules Loan Agreement, allowing it to borrow up to $200 million, with an initial draw of $30 million used to repay previous debt and fund ongoing operations.

Operationally, Savara's research and development expenses increased by 17.8% to $20.8 million for the second quarter of 2025, driven by costs related to the MOLBREEVI program, including chemistry, manufacturing, and regulatory affairs. General and administrative expenses surged by 92.3% to $10.7 million, reflecting the hiring of additional personnel and increased commercial activities. As of June 30, 2025, the company had approximately 216.4 million shares outstanding, up from 182.6 million a year earlier, indicating a potential increase in shareholder dilution as the company continues to seek funding.

Looking ahead, Savara anticipates continued operating losses as it invests in the development of MOLBREEVI and seeks regulatory approval. The company has sufficient capital to fund its planned activities for at least the next twelve months but may need to raise additional funds to support its ongoing operations and potential commercialization efforts. The future funding requirements will depend on various factors, including the pace of clinical development and the outcomes of regulatory interactions.