Savara(US:SVRA)2025-11-12 21:05Financial Performance - Savara reported a net loss of $29.6 million for the three months ended September 30, 2025, compared to a net loss of $24.2 million for the same period in 2024, representing an increase of 21.9%[102] - Net loss for the nine months ended September 30, 2025, was $86.6 million, an increase of $19.8 million compared to a net loss of $66.8 million in the same period of 2024[120] - The company has an accumulated deficit of approximately $575.9 million as of September 30, 2025[102] Expenses - Research and development expenses increased by $0.3 million, or 1.4%, to $20.6 million for the three months ended September 30, 2025, primarily due to costs associated with the MOLBREEVI program[117] - General and administrative expenses rose by $3.6 million, or 60.1%, to $9.6 million for the three months ended September 30, 2025, driven by the addition of personnel and related costs[118] - Research and development expenses increased by $5.8 million, or 10.5%, to $60.5 million for the nine months ended September 30, 2025, primarily due to costs related to the MOLBREEVI program[121] - General and administrative expenses rose by $12.3 million, or 71.8%, to $29.5 million for the nine months ended September 30, 2025, driven by personnel additions and commercial activities[122] Cash and Financing - As of September 30, 2025, Savara had cash and cash equivalents of $16.3 million and short-term investments of $108.1 million[104] - The company raised approximately $597.9 million in net cash proceeds since inception, primarily from stock offerings and debt financings[101] - The October 2025 public offering resulted in net proceeds of approximately $140.0 million, intended for working capital and clinical development[106] - Cash used in operating activities was $76.0 million for the nine months ended September 30, 2025, compared to $65.8 million in 2024[128] - Cash provided by financing activities was $2.2 million for the nine months ended September 30, 2025, primarily from the Hercules Loan Agreement[131] - The Hercules Loan Agreement provides a loan facility of up to $200 million, with an initial tranche of $30 million drawn to repay obligations and fund operations[124] Regulatory and Development Plans - Savara plans to resubmit the Biologics License Application for MOLBREEVI in December 2025 and request Priority Review from the FDA[100] - The company entered into a Purchase Agreement with RTW Investments for $75.0 million upon FDA approval of MOLBREEVI, with royalty payments ranging from 7.0% to 1.0% of net sales[107] - The FDA is currently not accepting new drug applications due to a government shutdown, which may impact the timing of Savara's BLA review[109] - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained for its product candidate[132] Other Financial Information - The company recognized a gain on foreign currency transactions of $0.7 million for the nine months ended September 30, 2025, compared to $0.3 million in 2024[142]