Press release
Savara Reports First Quarter 2022 Financial Results and Provides Business Update
Pivotal Phase 3 IMPALA-2 Trial of Novel Inhaled Biologic, Molgramostim Nebulizer Solution (Molgramostim), in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
About this update from Savara, Inc.
[{"type":"text","content":"\n\nPivotal Phase 3 IMPALA-2 Trial of Novel Inhaled Biologic, Molgramostim Nebulizer Solution (Molgramostim), in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Remains On-Track for a 20-Month Enrollment, with Top Line Data Expected at the End of 2Q 2024\n\n\n\n\nCompany Ends Quarter with ~$152M – Reiterates Belief it is Sufficiently Capitalized Through 2025, ~18 Months Beyond Anticipated IMPALA-2 Top Line Data Readout\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, 2022 and provided a business update.\n\n“As recently reported, we continue to steadily advance IMPALA-2, our pivotal Phase 3 clinical trial of molgramostim, a novel inhaled biologic,” said Matt Pauls, Chair and CEO, Savara. “Despite the ongoing global unpredictability of COVID-19 and current geopolitical issues affecting Europe, we reaffirm our guidance of top line data by the end of 2Q 2024. With a cash position of ~$152M at the end of the first quarter of 2022, and a recent debt refinancing that reduced our cost of capital and strengthened our balance sheet, we believe that we are funded through 2025.”\n\nFirst Quarter Financial Results (Unaudited)\n\nSavara’s net loss for the three months ended March 31, 2022 was $8.3 million, or $(0.05) per share, compared with a net loss of $10.2 million, or $(0.13) per share, for the three months ended March 31, 2021.\n\nResearch and development expenses decreased by $1.9 million, or 25.1%, to $5.7 million for the three months ended March 31, 2022 from $7.6 million for the three months ended March 31, 2021. The decrease was primarily attributable to an ~$2.5 million decrease in costs associated with the close-out and wind-down of activities related to the inhaled vancomycin development program. This decrease was partially offset by an ~$0.5 million increase in costs associated with the molgramostim development program for the treatment of aPAP. Molgramostim costs are related to the continued screening and enrollment of patients as well as Chemistry, Manufacturing, and Controls (\"CMC\") activities associated with the IMPALA-2 trial.\n\nGeneral and administrative expenses decreased by $0.4 million, or 15.3%, to $2.4 million for the three months ended March 31, 202...