Earnings

Savara's Third-Quarter Loss Widens to $43.0 Million

The Tip Desk · November 12, 2026 · 3 min read

Combined cash and short-term investments fell to about $129.6 million as the company spent down toward a November 22 PDUFA date for MOLBREEVI.

Savara Inc. (SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, reported a net loss of $43.0 million for the three months ended September 30, 2026, up from $29.6 million a year earlier.

The loss widened from $40.2 million in the prior quarter and $37.3 million in the quarter before that, as the company continued to fund MOLBREEVI, its inhaled GM-CSF candidate for autoimmune pulmonary alveolar proteinosis, and to build commercial infrastructure ahead of a planned launch.

Research and development expenses were $24.9 million, up 21.1% from $20.6 million a year earlier. The company said the increase was primarily due to higher personnel costs, mainly from increased stock-based compensation; technical operations and clinical activities supporting MOLBREEVI; and higher regulatory affairs and quality assurance consulting costs.

General and administrative expenses were $18.5 million, up 92.6% from $9.6 million a year earlier. Savara attributed the rise to higher personnel costs from stock-based compensation, headcount growth and IT costs as it builds its commercial team, plus commercial activities in preparation for the planned product launch.

Total operating expenses were $43.5 million. Other income, net was $553,000.

Cash and cash equivalents were $29.8 million as of September 30, 2026, down from $41.8 million as of June 30, 2026. Short-term investments were $99.8 million. Combined cash, cash equivalents and short-term investments were approximately $129.6 million, down from approximately $173.0 million at June 30.

The accumulated deficit was approximately $728.6 million.

In April 2026, the FDA extended the review period for the MOLBREEVI BLA after determining that the company’s responses to information requests constituted a major amendment, moving the PDUFA target action date to November 22, 2026. The European Medicines Agency had validated the marketing authorization application in March 2026, and the U.K. MHRA had validated the application in April 2026 under Accelerated Review with a 150-day assessment duration.

Savara said it expects research and development expenses to remain significant as it advances MOLBREEVI through regulatory review, including investment in regulatory support, contract manufacturing, a second-source manufacturer and CMC supplies. It said it expects to incur significant additional expenses and continue to incur operating losses for at least the next several years.

Subject to conditions including FDA approval of MOLBREEVI, the company may draw future tranches under the Hercules Loan Agreement, as amended, which provides for a facility of up to $105 million, and under a royalty purchase and sale agreement with RTW Investments, LP.

The company said it has sufficient capital to fund many of its planned activities but may need to raise additional capital to further fund development, seek regulatory approvals and begin commercialization of any approved product. It said failure to raise capital as and when needed would have a negative impact on its financial condition and its ability to develop the product candidate.