On November 7, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported financial results for the third quarter ending September 30, 2019 and provided a business update (Press release, Savara, NOV 7, 2019, View Source [SID1234550793]).

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"Based on the totality of evidence, we continue to believe that Molgradex has a clinically meaningful treatment effect on aPAP and we are committed to this program," said Rob Neville, Chief Executive Officer, Savara. "In the near-term, gaining clarity on the best regulatory path forward is our highest corporate priority and we look forward to further collaborating with the FDA and EMA in this regard."

Recent Developments and Upcoming Highlights

Molgradex for aPAP

Announced U.S. Food and Drug Administration (FDA) feedback from Type C meeting that indicated the data included in the briefing package did not provide sufficient evidence of efficacy and safety.
Working in consultation with the FDA to determine the best regulatory path forward for the program.
Presented efficacy and safety results from IMPALA, a Phase 3 study evaluating Molgradex for the treatment of aPAP, at the European Respiratory Society (ERS) International Congress. (Slides from the meeting can be found here.)
Expect to announce data from the open-label follow-up period of IMPALA (weeks 24-48) in Q1 2020.
Plan to initiate discussions with the European Medicines Agency (EMA) regarding the suitability of the IMPALA data for a potential Marketing Authorization Application (MAA).
Molgradex for nontuberculous mycobacterial (NTM) lung infection

Continue to expect top line results from OPTIMA, a Phase 2a clinical study evaluating Molgradex for the treatment of NTM in non-cystic fibrosis (CF) patients, in Q1 2020.
AeroVanc

Anticipate enrollment completion for AVAIL, a pivotal Phase 3 clinical study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF, in the first half of 2020 with top line results expected in late 2020 or early 2021.
As of November 1, 2019, the study had completed enrollment in the adult population and had enrolled 123 out of a target of 150 patients in the primary analysis population (younger subjects between 6-21 years of age).
Third Quarter Financial Results (Unaudited)

Savara’s net loss attributable to common stockholders for the three months ended September 30, 2019 was $12.4 million, or $(0.30) per share, compared with a net loss attributable to common stockholders of $12.6 million, or $(0.36) per share, for the three months ended September 30, 2018.

Research and development expenses were $9.6 million for the three months ended September 30, 2019, compared with $9.5 million for the three months ended September 30, 2018. The increase was primarily due to approximately $0.6 million in increased costs associated with the development of Molgradex, which was offset by $0.5 million in decreased AeroVanc study costs related to Phase 3 activities.

General and administrative expenses for the three months ended September 30, 2019 were $2.8 million, compared with $3.1 million for the three months ended September 30, 2018. The decrease was primarily due to an approximately $0.6 million noncash stock-based compensation charge incurred in the third quarter of 2018 offset in part by $0.2 million increased personnel costs for the three months ended September 30, 2019.

As of September 30, 2019, Savara had a carrying value of its debt of approximately $25.0 million and had cash, cash equivalents, and short-term investments of approximately $106.3 million. Under the current operating plan, the Company believes this is sufficient capital to fund planned operations well into 2021.

Conference Call/Webcast with Slides

Savara management will host a conference call/webcast with accompanying slides at 4:30 p.m. Eastern Time (ET) / 1:30 p.m. Pacific Time (PT). Shareholders and other interested parties may access the call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and requesting the "Savara Inc." call. A live webcast of the call can be accessed on the Investors page of Savara’s website at View Source

Approximately one hour after the call, a telephone replay will be available and will remain available through November 14, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10135923. A webcast replay will be available on the Investors page of Savara’s website and will remain available for 30 days.