Press release
Savara Reports Third Quarter Financial Results and Provides Business Update
Top Line Data from the Pivotal Phase 3 IMPALA-2 Trial Remains On-Track to Read Out by End of 2Q 2024 — 48-week placebo-controlled trial is evaluating
About this update from Savara, Inc.
[{"type":"text","content":"\n\n Top Line Data from the Pivotal Phase 3 IMPALA-2 Trial Remains On-Track to Read Out 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\nCompany Expects to Launch an aPAP Antibody Blood Test and Disease Awareness Campaign in the U.S. by End of Year\n\n\n\nFollowing the Close of an ~$80M Equity Financing, the Company Ended the Quarter with ~$168.3M in Cash, Cash Equivalents, and Short-term Investments\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 third quarter ending September 30, 2023 and provided a business update.\n\n\n“We remain on track to report top line data from the pivotal, Phase 3 IMPALA-2 trial by the end of the second quarter 2024,” said Matt Pauls, Chair and CEO, Savara. “In parallel, we are working to provide pulmonologists in the U.S. and Europe with a simple, accurate, no-cost, laboratory-based antibody blood test for aPAP. This antibody test is expected to be available in the U.S. by the end of this year and in Europe by the end of 2024. We will also be launching a supporting disease awareness campaign that will educate pulmonologists on the hallmark signs and symptoms of aPAP. Lastly, with approximately $168M in cash, we have a strong balance sheet and believe we are capitalized into 2026.”\n\n\nThird Quarter Financial Results (Unaudited)\n\n\nSavara's net loss for the third quarter of 2023 was $16.6 million, or $(0.10) per share, compared with a net loss of $10.4 million, or $(0.07) per share, for the third quarter of 2022.\n\n\nResearch and development expenses increased by $5.7 million, or 70.1%, to $13.9 million for the three months ended September 30, 2023 from $8.2 million for the three months ended September 30, 2022. This increase was primarily due to the performance of tasks related to our molgramostim program, which included approximately $2.5 million of costs related to our chemistry, manufacturing, and controls activities, $1.8 million of costs related to our IMPALA-2 trial, including CRO-related activities, $0.5 million of costs related to quality assurance, a...