LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) reported a wider second-quarter loss as the rare-disease drug developer expanded its commercial operation ahead of a November 22 U.S. regulatory decision on MOLBREEVI.
The company lost $40.2 million, or 16 cents per share, during the quarter ended June 30, compared with a loss of $30.4 million, or 14 cents per share, a year earlier.
Noncash stock-based compensation accounted for $7.8 million of the latest quarterly loss, up from $2.7 million in the prior-year period.
General and administrative expenses rose 78.2% to $19 million from $10.7 million, primarily reflecting $7.5 million in higher personnel costs tied to increased stock compensation and hiring for a potential product launch.
Savara also recorded an $800,000 increase in certain commercial expenses as it built the infrastructure needed to bring MOLBREEVI to the U.S. market if approved.
The Food and Drug Administration set a November 22, 2026, target date to act on the company’s biologics license application.
“The U.S. represents our nearest-term opportunity,” Chairman and Chief Executive Officer Matt Pauls stated. “Our focus is on the potential launch of MOLBREEVI in the U.S., supported by a strong balance sheet to ensure commercial readiness.”
Regulators are also reviewing marketing applications in the European Union and United Kingdom. Decisions are expected in the first quarter of 2027 from the European Medicines Agency and in the fourth quarter of 2026 from the U.K.’s Medicines and Healthcare products Regulatory Agency.
Research and development spending increased 5.8% to $22 million from $20.8 million.
Higher personnel costs added $2 million to research expenses, partly offset by a $600,000 decrease in regulatory and quality-assurance consulting costs and a $200,000 decline in chemistry, manufacturing and controls expenses.
Savara ended June with approximately $173 million in cash, cash equivalents and short-term investments, along with about $30.1 million in debt.
The company could receive as much as approximately $150 million in additional nondilutive capital if MOLBREEVI secures FDA approval.
Clinical data presented at the American Thoracic Society conference showed that molgramostim produced continued long-term improvements in lung function and respiratory health-related quality of life, according to Savara.
European and Australian patent authorities also granted patents covering MOLBREEVI’s liquid formulation, providing protection through March 2041.
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