Press release
Savara Reports Third Quarter 2021 Financial Results and Provides Business Update
Continued to Advance Pivotal Phase 3 IMPALA 2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP);
About this update from Savara, Inc.
[{"type":"text","content":"\n\nContinued to Advance Pivotal Phase 3 IMPALA 2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP); 20-Month Enrollment Guidance Remains On-Track\n\n\n\nReceived Acceptance from Pediatric Committee of the European Medicines Agency (EMA) on Proposed Revised Pediatric Investigation Plan (PIP) for Molgramostim\n\n\n\nEnded Quarter with Cash Balance of ~$171M―Company Believes it is Sufficiently Capitalized Through 2025, ~18 Months Beyond Anticipated IMPALA-2 Top-Line Data Readout at End of Q2 2024\n\n\n\nBolstered Company Leadership with the Appointments of Peter Clarke, Executive Vice President of Global Technical Operations and Charles LaPree, Senior Vice President of Global Regulatory Affairs & Quality Assurance\n\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today reported financial results for the third quarter ending September 30, 2021 and provided a business update.\n\n“The team is focused and driving hard on advancing the pivotal Phase 3 IMPALA 2 trial,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “Given that an increasing number of sites are actively screening and enrolling patients, and we completed an important regulatory milestone with EMA’s acceptance of our proposed revised PIP, we are pleased with our progress over the last quarter. While the potential impact of COVID-19 and the flu over the winter is unknown, we remain confident in our guidance of a 20-month enrollment timeframe and top-line data by the end of Q2 2024. Finally, we significantly bolstered our inhalation delivery and biological product expertise in the manufacturing, regulatory, and quality functions with the addition of Peter Clarke and Charles LaPree.”\n\nThird Quarter Financial Results (Unaudited)\nSavara’s net loss attributable to common stockholders for the three months ended September 30, 2021, was $10.5 million, or $(0.07) per share, compared with a net loss attributable to common stockholders of $11.1 million, or $(0.18) per share, for the three months ended September 30, 2020.\n\nResearch and development expenses increased by $0.9 million, or 16.6%, to $6.5 million for the three months ended September 30, 2021 from $5.6 million for the three months ended September 30, 20...