Savara Inc. (NASDAQ:SVRA) Q2 2020 Earnings Conference Call - Final Transcript

Aug 06, 2020 • 04:30 pm ET

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Savara Inc. (NASDAQ:SVRA) Q2 2020 Earnings Conference Call - Final Transcript

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Executive
Robert Neville

major disruptions from the virus, we are putting proactive measures in place to preserve the continuity of study to any geographies experienced a resurgence.

Examples of such measures include telemedicine - visits where possible. Separately, our manufacturing and drugs supply for IMPALA 2 is progressing as planned with no discernible impact on COVID.

On the topic of COVID, you may recall in March, we announced that due to practical limitations caused by the virus, we stopped enrolling patients in the Phase III AVAIL study and exploratory ENCORE study. Fortunately, we were able to keep the majority of enrolled patients in both and through post collaboration with the research centers, the studies continued.

Regarding AVAIL enrollment numbers were smaller than originally expected with 133 enrolled out of the target of 150 in the primary analysis population, and that being younger patients between six and 21 years old. The older patient population completed to 55 out of targeted 50. By enrolling fewer patients than expected in our primary population, there will be a reduction in its count.

Additionally, as we near the end of the study and think about the addressable nursing market we have to consider the impacts of Trikafta the newly approved CFTR modulator that has been transformative in the treatment of CF.

While this possible of AeroVanc could be affective when added to treatment with Trikafta the AVAIL study does not assess that combination. Regardless, we remain optimistic that AeroVanc may play an important role in the treatment of Mercer infections by addressing the needs of specific patients within the CF community. And we look forward to announcing top line results to the AVAIL study in early 2021.

With regard to ENCORE, that study was about 50% enrolled with 14 patients out of the target of 50 when enrollment was halted. As a reminder, ENCORE is - non controlled 48-weeks exploratory study evaluating alternatives to the treatment of nontuberculous mycobacterial or NTM lung infection the CX. Upon this conclusion, we will determine next steps for the NTM program which also include the exploratory OPTIMA studies in non CF patients, for which we announced applied results in March.

Lastly, let's turn to our U.S. development programs. Those of you not familiar, Apulmiq is an inhaled for classism and developed for the treatments of non-CF bronchitis. Our team is further analyzing the data from the previous studies that is [Phonetic]OVID 3 and OVID 4[/Phonetic], and working closely with bronchitis key opinion leaders worldwide on the design of a conservatory program for future discussions with the FDA.

After similar deliberations and discussions with the agency, you will have a better sense of the necessary resources to advance Apulmiq in the U.S. Options for financing and Phase III conservatory programs include partnering to various forms of project financing. With three Phase III programs in our top-line, the remainder of 2020 will be a very busy time operation. And importantly, we are confident about our ability to execute, as we believe we are sufficiently