Press release
Savara Reports Fourth Quarter / Year-End 2022 Financial Results and Provides Business Update
Pivotal Phase 3 IMPALA-2 Trial Remains On-Track with Top Line Data Expected End of 2Q 2024 IMPALA-2 is evaluating molgramostim nebulizer solution
About this update from Savara, Inc.
[{"type":"text","content":"\n\nPivotal Phase 3 IMPALA-2 Trial Remains On-Track with Top Line Data Expected End of 2Q 2024\n\n\nIMPALA-2 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\nIMPALA-2 Trial Continues, Unmodified, Following Positive Review from Independent Data Monitoring Committee (DMC)\n\n\nDMC assessed the safety and benefit/risk of molgramostim in aPAP patients\n\n\n\n\nCompany To Launch Global aPAP Market Development Campaign in 2H23\n\n\nCompany Ends Quarter with ~$126M, Believes it is Sufficiently Capitalized Through 2025\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 fourth quarter and full year ending December 31, 2022 and provided a business update.\n\n“Enrollment in the pivotal Phase 3 IMPALA-2 trial remains on-track, and we continue to anticipate reporting top line safety and efficacy data by the end of 2Q 2024,” said Matt Pauls, Chair and CEO, Savara. “As we approach the milestone of enrollment completion, I am proud of the team’s ability to advance the molgramostim development program during the headwinds of the COVID pandemic. That operational focus will extend to the launch of a global aPAP market development campaign in the second half of the year. Finally, in 2022 we maintained our track record of fiscal discipline and believe we are fully capitalized through 2025.”\n\nFourth Quarter Financial Results (Unaudited)\n\nSavara's net loss for the fourth quarter of 2022 was $10.3 million, or $(0.07) per share, compared with a net loss of $11.3 million, or $(0.07) per share, for the fourth quarter of 2021.\n\nResearch and development expenses were $7.6 million for the fourth quarter of 2022, which were equivalent to the fourth quarter of 2021.\n\nGeneral and administrative expenses for the fourth quarter of 2022 and 2021 were $3.2 million and $3.0 million, respectively.\n\nAs of December 31, 2022, the Company had cash, cash equivalents and short-term investments of $125.9 million.\n\nFiscal Year 2022 Financial Results\n\nThe Company’s net loss for the year ended December 31, 2022 was $38.2 million, or $(0.25) per share, compared with a net loss of $43.0 million, or...