Press release
Savara Reports First Quarter 2024 Financial Results and Provides Business Update
Pivotal Phase 3 IMPALA-2 Trial Remains On-track, Top Line Results Expected by End of 2Q 2024 48-week placebo-controlled trial is evaluating molgramostim
About this update from Savara, Inc.
[{"type":"text","content":"\n\nPivotal Phase 3 IMPALA-2 Trial Remains On-track, Top Line Results Expected 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\n\nPending Results from the IMPALA-2 Trial, a Biologics License Application (BLA) Filing is Anticipated in 1H 2025\n\n\n\n\nWith ~$143M in Cash and Short-term Investments, the Company Continues to Believe 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 first quarter ending March 31, 2024 and provided a business update.\n\n\n“The IMPALA-2 trial remains on-track and we look forward to reporting top line results by the end of the second quarter,” said Matt Pauls, Chair and CEO, Savara. “Following that, and assuming positive data, we expect to file a BLA in the first half of 2025. Importantly, with $143 million in cash and investments, we believe we are capitalized into 2026 which is well beyond the data read-out and includes investments in programs such as the extension of the IMPALA-2 open-label period from 48 weeks to 96 weeks, anticipated launch of a global Expanded Access program for molgramostim, build out of the U.S. Commercial infrastructure, and pre-Commercial preparations in Europe.”\n\n\nFirst Quarter Financial Results (Unaudited)\n\n\nSavara's net loss for the first quarter of 2024 was $20.3 million, or $(0.11) per share, compared with a net loss of $10.6 million, or $(0.07) per share, for the first quarter of 2023.\n\n\nResearch and development expenses increased by $8.1 million, or 92.3%, to $16.8 million for the three months ended March 31, 2024 from $8.7 million for the three months ended March 31, 2023. The increase was largely due to the performance of tasks related to the molgramostim program, which included approximately $4.3 million associated with chemistry, manufacturing, and controls activities and primarily driven by initiatives at second source drug substance manufacturers, $1.0 million related to the IMPALA-2 clinical trial, including clinical research organization (CRO) related activities, $0.6 ...