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Dec 31, 2019
Savara Q4 2019 Earnings Report
Reported financial results for Q4 and year-end 2019 and provided a business update.
Key Takeaways
Savara reported positive results from the IMPALA open-label follow-up, is planning an additional Phase 3 study of Molgradex for aPAP, and announced top-line microbiology data from OPTIMA. The company's net loss for the fourth quarter of 2019 was $31.7 million, or $(0.72) per share.
Announced Positive Results from IMPALA Open-Label Follow-Up Period That Demonstrate Continued Improvement After Longer Term Exposure to Molgradex
Company Planning an Additional Phase 3 Study of Molgradex for the Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announced Top Line Microbiology Data from OPTIMA, a Phase 2a Clinical Study in Nontuberculous Mycobacterial (NTM) Lung Infection
FDA granted Breakthrough Therapy Designation for Molgradex for the treatment of aPAP
Savara
Savara
Forward Guidance
Savara anticipates continuing AVAIL enrollment until Q2 2020, expecting to enroll approximately 140 younger patients, with top-line results anticipated in early 2021. The company also intends to present more comprehensive data from the IMPALA and OPTIMA studies at upcoming scientific conferences and will continue to assess data from the OPTIMA study. Next steps for the NTM program will be determined once results from ENCORE are available.
Positive Outlook
- Molgradex could improve outcomes for patients with aPAP
- Continue conversations with the FDA
- Get clarity from the agency regarding the design and endpoints of a second Phase 3 study in aPAP
- Present more comprehensive data from the IMPALA study at an upcoming scientific conference and/or submit it for consideration in a peer-reviewed journal
- Submit the full data set from OPTIMA for consideration at an upcoming scientific conference
Challenges Ahead
- The outcome of ongoing discussions with the FDA
- Risks and uncertainties associated with the outcome of ongoing and planned clinical trials for our product candidates
- The ability to project future cash utilization and reserves needed for contingent future liabilities and business operations
- The availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs
- The ability to obtain the necessary patient enrollment for our product candidates in a timely manner