Press release
Savara Reports Fourth Quarter / Year-End 2021 Financial Results and Provides Business Update
Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Progressing, with Most
About this update from Savara, Inc.
[{"type":"text","content":"\n\nPivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Progressing, with Most of the ~50 Clinical Trial Sites Activated\n\n\nTrial Remains On-Track for a 20-Month Enrollment, with Top Line Data Expected at the End of 2Q 2024\n\n\nCompany Ends Quarter with ~161M – 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), an orphan lung disease company, reported financial results for the fourth quarter and full year ending December 31, 2021 and provided a business update.\n\n“The company underwent a significant amount of positive change in 2021. We streamlined the pipeline to focus solely on the molgramostim development program, strengthened our management team with key hires in clinical, regulatory, and CMC and improved our financial position with a $130M equity raise,” said Matt Pauls, Chair and CEO, Savara. “With a cash position of ~$161M at the end of 2021, and a track record of fiscal discipline, we believe we are funded through 2025 – which is well beyond the anticipated top line read-out of IMPALA-2, our pivotal Phase 3 clinical trial in aPAP. We continue to advance the IMPALA-2 trial with most of the approximately 50 clinical trial sites now activated, and despite the ongoing COVID-19 pandemic and current geopolitical issues impacting parts of Europe, we reaffirm our guidance of top line data by the end of 2Q 2024.”\n\nFourth Quarter Financial Results (Unaudited)\n\nSavara's net loss for the fourth quarter of 2021 was $11.3 million, or $(0.07) per share, compared with a net loss of $13.7 million, or $(0.23) per share, for the fourth quarter of 2020.\n\nResearch and development expenses were $7.6 million for the fourth quarter of 2021, compared with $10.2 million for the fourth quarter of 2020.\n\nGeneral and administrative expenses for the fourth quarter of 2021 and 2020 were $3.0 million and $2.8 million, respectively.\n\nAs of December 31, 2021, the Company had cash, cash equivalents and short-term investments of $161.2 million.\n\nFiscal Year 2021 Financial Results\n\nThe Company’s net loss for the year ended December 31, 2021 was $43.0 million, or $(0.32) per share, compared with a net loss of $49.6 million...