Savara Inc
NASDAQ:SVRA
Savara Inc
Savara, Inc. is a clinical-stage pharmaceutical company, which engages in the development and commercialization of novel therapies for the treatment of serious or life-threatening rare respiratory diseases. The company is headquartered in Austin, Texas and currently employs 22 full-time employees. The company went IPO on 2001-06-25. The firm is focused on rare respiratory diseases. The Company’s lead program, molgramostim nebulizer solution (molgramostim), is an inhaled granulocyte-macrophage colony-stimulating factor in Phase III development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim an inhaled formulation of recombinant human GM-CSF, is being developed for the treatment of aPAP. Pulmonary alveolar proteinosis (PAP) is a rare lung disease characterized by the build-up of surfactant in the alveoli or air sacs of the lungs.
Savara, Inc. is a clinical-stage pharmaceutical company, which engages in the development and commercialization of novel therapies for the treatment of serious or life-threatening rare respiratory diseases. The company is headquartered in Austin, Texas and currently employs 22 full-time employees. The company went IPO on 2001-06-25. The firm is focused on rare respiratory diseases. The Company’s lead program, molgramostim nebulizer solution (molgramostim), is an inhaled granulocyte-macrophage colony-stimulating factor in Phase III development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim an inhaled formulation of recombinant human GM-CSF, is being developed for the treatment of aPAP. Pulmonary alveolar proteinosis (PAP) is a rare lung disease characterized by the build-up of surfactant in the alveoli or air sacs of the lungs.
IMPALA 2 Phase III Study: Savara finalized the design for its pivotal IMPALA 2 Phase III trial in aPAP, targeting 160 patients and aiming to start enrollment in Q1 2021.
COVID-19 Response: The company is taking proactive steps, including telemedicine visits, to minimize study disruption from COVID-19 and reports no supply chain impact so far.
Study Progress: Enrollment in the AVAIL and ENCORE studies was halted early due to COVID-19, but most patients remain on-study and AVAIL top-line results are expected in early 2021.
Financial Position: Savara ended Q2 2020 with about $100 million in cash and equivalents and $25 million in debt, expecting this to fund operations and upcoming milestones.
R&D and SG&A Costs: Both research and development and general administrative expenses declined significantly year-over-year, reflecting winding down of some studies and reduced commercial activities.
Regulatory and Strategic Outlook: Management expressed confidence in the IMPALA 2 design after productive FDA/EMA discussions, and sees strong potential for the Molgradex program.
