Press release
Savara Reports Third Quarter 2022 Financial Results and Provides Business Update
Pivotal Phase 3 IMPALA-2 Trial Remains On-Track, Top Line Data Expected End of 2Q 2024 IMPALA-2 is evaluating molgramostim nebulizer solution (molgramostim),
About this update from Savara, Inc.
[{"type":"text","content":"\n\n Pivotal Phase 3 IMPALA-2 Trial Remains On-Track, Top Line Data Expected End of 2Q 2024\n\n\nIMPALA-2 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\nReceived Acceptance from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) on a Revised Pediatric Investigation Plan (PIP) for Molgramostim in aPAP\n\n\nAppoints Raymond Pratt, M.D., Chief Medical Officer\n\n\nCompany Ends Quarter with ~$134M, Believes it is Sufficiently Capitalized Through 2025\n\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2022 and provided a business update.\n\n“As we’ve said over the last year, challenges related to COVID and flu surges, geopolitical issues, and supply chain constraints are ongoing and will likely continue,” said Matt Pauls, Chair and CEO, Savara. “However, IMPALA-2, the pivotal Phase 3 trial of our novel inhaled biologic, remains on-track for a top line read-out by the end of 2Q 2024. Importantly, the Company has a strong balance sheet, and we believe we have more than three years of operating runway which is approximately 18 months beyond top line results. Finally, we are happy to announce the appointment of Raymond Pratt, M.D. as Chief Medical Officer, effective immediately. With approximately 30 years of global drug development experience, and numerous regulatory approvals, Dr. Pratt is a proven biopharmaceutical Chief Medical Officer, and we are confident that he will provide significant clinical development, medical affairs, and regulatory leadership.”\n\n“I am delighted to join Savara as we advance the molgramostim development program,” said Raymond Pratt, M.D., newly appointed Chief Medical Officer, Savara. “I am impressed by the quality of the team and progress they have made executing the IMPALA-2 trial. I look forward to building on that momentum so that we can potentially fill the serious unmet needs of patients with aPAP.”\n\nThird Quarter Financial Results (Unaudited)\n\nSavara’s net loss attributable to common stockholders for the three months ended September 30, 2022, was $10.4 million, or $(0.07) per...