Press release
Savara Reports Fourth Quarter/Year-End 2023 Financial Results and Provides Business Update
Remains On-Track to Report Top Line Data from the Pivotal Phase 3 IMPALA-2 Trial by End of 2Q 2024 48-week placebo-controlled trial is evaluating
About this update from Savara, Inc.
[{"type":"text","content":"\n\nRemains On-Track to Report Top Line Data from the Pivotal Phase 3 IMPALA-2 Trial by End of 2Q 2024\n\n\n48-week placebo-controlled trial is evaluating molgramostim nebulizer solution (molgramostim), a novel inhaled biologic, for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease\n\n\n\n\n\n\nAnticipate Filing Biologics License Application (BLA) in 1H 2025, Pending Outcome of IMPALA-2 Trial\n\n\n\nWith ~$162M in Cash and Short-term Investments, Company Believes it is Sufficiently Capitalized into 2026\n\n\n\n LANGHORNE, Pa.--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2023 and provided a business update.\n\n\n“We look forward to reporting IMPALA-2 top line results at the end of the second quarter and, assuming positive data, anticipate filing the BLA in the first half of 2025,” said Matt Pauls, Chair and CEO, Savara. “2023 was a year of strong execution that included the on-time, over-enrollment of the Phase 3 IMPALA-2 trial and an analysis of a health claims database that identified ~3,600 currently diagnosed aPAP patients and another ~1,400 potential, currently undiagnosed, aPAP patients in the U.S. Additionally, we launched aPAP ClearPathTM, a simple, accurate, no-cost, lab-developed GM-CSF autoantibody blood test, along with a disease state awareness campaign, that is educating U.S. pulmonologists about the disease and need for earlier testing. Finally, we completed an $80 million equity financing last July, and with $162 million in cash and investments and a track record of strong fiscal discipline, we believe we are capitalized into 2026.”\n\n\nFourth Quarter Financial Results (Unaudited)\n\n\nSavara’s net loss for the fourth quarter of 2023 was $16.1 million, or $(0.09) per share, compared with a net loss of $10.3 million, or $(0.07) per share, for the fourth quarter of 2022.\n\n\nResearch and development expenses for the fourth quarter of 2023 and 2022 were $12.7 million and $7.6 million, respectively.\n\n\nGeneral and administrative expenses for the fourth quarter of 2023 and 2022 were $4.9 million and $3.2 million, respectively.\n\n\nAs of December 31, 2023, the Company had cash, cash equivalents and s...