Press release
Savara Reports Second Quarter Financial Results and Provides Business Update
Fully Enrolled Pivotal Phase 3 IMPALA-2 Trial Remains On-Track to Report Top Line Data by End of 2Q 2024 — 48-week placebo-controlled trial is evaluating
About this update from Savara, Inc.
[{"type":"text","content":"\n\nFully Enrolled Pivotal Phase 3 IMPALA-2 Trial Remains On-Track to Report Top Line Data by End of 2Q 2024\n— 48-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~$105M in Cash and Cash Equivalents at the End of 2Q 2023\n\n\n\n\nFurther Strengthened Balance Sheet in July with an ~$80M Equity Financing, Resulting in ~$180M in Pro Forma Cash After Giving Effect to the Offering\n\n\n\n\nAnne Erickson, SVP, Global Business Operations, Promoted to Chief Business Officer, Effective Immediately\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 second quarter ending June 30, 2023 and provided a business update.\n\n\n“The Company continues to make strong progress with the molgramostim development program,” said Matt Pauls, Chair and CEO, Savara. “In June, we announced the Phase 3 IMPALA-2 trial completed enrollment on-time with 164 patients randomized, four more than the target of 160, and our timeline remains on track for top line results by the end of 2Q 2024. Additionally, last month we further strengthened our balance sheet through an $80 million equity raise and now have approximately $180 million in pro forma cash.”\n\n\nSecond Quarter Financial Results (Unaudited)\n\n\nSavara's net loss for the second quarter of 2023 was $11.4 million, or $(0.07) per share, compared with a net loss of $9.2 million, or $(0.06) per share, for the second quarter of 2022.\n\n\nResearch and development expenses increased by $2.5 million, or 38.8%, to $8.9 million for the three months ended June 30, 2023 from $6.4 million for the three months ended June 30, 2022. This increase is primarily due to the performance of tasks related to our molgramostim program which includes increases of ~$0.6 million of costs related to our chemistry, manufacturing, and controls activities, ~$1.4 million of costs related to our IMPALA-2 trial, including contract research organization related activities, and ~$0.5 million in personnel and related costs.\n\n\nGeneral and administrative expenses increased by $0.3 million, or 11.7%, to $3.3 million for the thre...