Savara Inc. (NASDAQ:SVRA) Q4 2019 Earnings Conference Call - Final Transcript

Mar 12, 2020 • 04:30 pm ET


Savara Inc. (NASDAQ:SVRA) Q4 2019 Earnings Conference Call - Final Transcript


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Rob Neville

aPAP, our lead development program, was granted Breakthrough Therapy designation by the FDA.

Regarding the financing, the deal was led by Bain Capital Life Sciences with participation by existing and new investors. The additional funding means we find ourselves entering 2020 in a very strong cash position and able to execute on all our corporate priorities, specifically the net proceeds from the financing should sufficiently find the second Phase 3 study for the Molgradex aPAP program, as well as other operational expenses.

As always, we're grateful for the support of our investors like yourselves that believe in the company and our vision. In order to help us achieve this vision, we recently broadened the depth of our Board of Directors. Last December, we announced that Dr. An van Es-Johansson was appointed to our Board. An has deep expertise in orphan drug developments and an extensive background in the development of FDA and EMA approved orphan drugs. Additionally, as part of the financing, we welcome Dr. Ricky Sun, partner of Bain Capital Life Sciences to our Board. Ricky's experience includes leadership roles within biotech companies as well as healthcare investment funds and equity research on Wall Street.

Beyond the boardroom, we expanded our executive leadership team with the appointment of Dr. Badrul Chowdhury as Chief Medical Officer, sitting with me here in Austin. Badrul's appointment comes at a pivotal time as we advance Molgradex aPAP program through the next regulatory milestones. Badrul's two decades of regulatory leadership experience as Director of the FDA's Pulmonary, Allergy and Rheumatology division, the very division responsible for reviewing Molgradex in aPAP, where he presided over numerous drug development programs and approvals for pulmonary and orphan disease medicine.

We're glad that he is on Board as he will be instrumental in devising our regulatory strategy for development programs and guiding our interactions with regulatory bodies. For more information on Badrul's impressive background and to hear about why he joined Savara, I encourage you to read our most recent blog post that you can find on our IR page of our website. We're pleased to have attracted these highly experienced and then thoughtful industry leaders to Savara. Each of their respected talent complement our existing team and will no doubt prove invaluable as we capitalize on the many opportunities that lie ahead.

Rounding out the events from last quarter, I'll quickly touch on the Breakthrough Therapy Designation that the FDA granted to Molgradex for the treatment aPAP. We believe this designation, which was announced at the end of 2019 reflects the significance of Molgradex as an investigational product and is an important development as we embark on the second Phase 3 study for the program.

Breakthrough Designation is granted to drug candidates for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available treatment. Additionally, this designation allows for us to have increased collaboration and more frequent dialog with the FDA, as we enter this critical development period.

I will now ask Badrul