Press release
Savara Reports First Quarter Financial Results and Provides Business Update
Pivotal Phase 3 IMPALA-2 Trial Remains On-Track Company expects trial to be fully enrolled in June 2023, on-track to report top line data by end of 2Q 2024
About this update from Savara, Inc.
[{"type":"text","content":"\n\nPivotal Phase 3 IMPALA-2 Trial Remains On-Track\n\n\nCompany expects trial to be fully enrolled in June 2023, on-track to report top line data by end of 2Q 2024\n\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\nCompany Ends Quarter with ~$115M, Believes it is Sufficiently Capitalized Through 2025\n\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 first quarter ending March 31, 2023 and provided a business update.\n\n\n“In June of this year, we expect the pivotal Phase 3 IMPALA-2 trial to be fully enrolled, therefore, we remain on-track to report top line safety and efficacy data by the end of 2Q 2024,” said Matt Pauls, Chair and CEO, Savara. “Importantly, we believe we are fully capitalized through 2025, which is about 18 months beyond the top line data readout.”\n\n\nFirst Quarter Financial Results (Unaudited)\n\n\nSavara's net loss for the first quarter of 2023 was $10.6 million, or $(0.07) per share, compared with a net loss of $8.3 million, or $(0.05) per share, for the first quarter of 2022.\n\n\nResearch and development expenses increased by $3.1 million, or 53.7%, to $8.7 million for the three months ended March 31, 2023 from $5.7 million for the three months ended March 31, 2022. The increase was primarily due to performance of tasks related to our molgramostim program which included ~$2.0 million of costs related to our chemistry, manufacturing, and controls activities, ~$0.5 million of costs related to our IMPALA-2 trial, including CRO-related activities, and ~$0.6 million due to an increase in personnel.\n\n\nGeneral and administrative expenses increased by $1.0 million, or 43.0%, to $3.4 million for the three months ended March 31, 2023 from $2.4 million for the three months ended March 31, 2022. The increase was primarily attributable to the strategic addition of personnel and related costs for key positions to facilitate the management of our business and operations.\n\n\nAs of March 31, 2023, the Company had cash, cash equivalents and short-term investments of $114.8 million.\n\n\nAbout Savara\n\n\n...