On August 8, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported financial results for the second quarter ending June 30, 2019 and provided a business update (Press release, Savara, AUG 8, 2019, View Source [SID1234538548]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our highest corporate priority continues to be the Molgradex aPAP program," said Rob Neville, Chief Executive Officer, Savara. "While the IMPALA study did not achieve statistical significance on its pre-specified primary endpoint, the totality of the efficacy data are encouraging and reinforce the important role of Molgradex to improve oxygenation and reduce surfactant burden in these patients. Additionally, with adverse event frequencies similar to placebo, we believe this drug has a compelling risk-benefit profile. We are proceeding with regulatory interactions to determine the best path forward, while simultaneously preparing for an additional Phase 3 study should that be required."

Recent Developments and Upcoming Highlights

Molgradex for autoimmune pulmonary alveolar proteinosis (aPAP)

Reported top line results from IMPALA, a pivotal Phase 3 clinical study.
Granted a Type C meeting with the FDA, expect written responses from the agency in October 2019.
Anticipate filing for Breakthrough Designation in the U.S.
Continued strong enrollment in IMPALA-X, an open-label, multicenter extension study to determine the long-term safety and utilization of Molgradex in patients with aPAP. 32 out of 35 eligible patients have enrolled in the extension study, with no whole lung lavages reported and no drop-outs to-date.
Molgradex for nontuberculous mycobacterial (NTM) lung infection

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

Revised enrollment completion guidance for AVAIL, a pivotal Phase 3 clinical study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF.
― As of August 1, 2019, the study has enrolled 168 patients out of a target of 200. The approximate 50% screen failure rate with younger subjects has slowed enrollment. The screen failures are largely due to exacerbations between time of screening and randomization.
― Expect to complete patient enrollment in the first half of 2020 with top line results now expected in late 2020 or early 2021.
Exploratory Pipeline

Deprioritized the amikacin/fosfomycin program in order to focus resources on the Company’s later stage programs. Future development will be considered at a later time.
Second Quarter Financial Results (Unaudited)

Savara’s net loss attributable to common stockholders for the three months ended June 30, 2019 was $21.9 million, or $(0.57) per share, compared with a net loss attributable to common stockholders of $11.6 million, or $(0.37) per share, for the three months ended June 30, 2018.

Research and development expenses were $10.5 million for the three months ended June 30, 2019, compared with $9.3 million for the three months ended June 30, 2018. The increase was primarily due to $2.2 million in increased development costs associated with the development of Molgradex and AeroVanc, which was partially offset by $1.0 million in expense in the form of common stock issued in connection with an asset purchase in the second quarter of 2018.

General and administrative expenses for the three months ended June 30, 2019 were $4.2 million, compared with $2.5 million for the three months ended June 30, 2018. The increase was primarily due to increased personnel costs and other legal, accounting, insurance, commercial strategy, business development, and operating activities.

During the three months ended June 30, 2019, we recognized a $7.4 million non-cash impairment charge to the carrying value of our goodwill following the results of our IMPALA study.

As of June 30, 2019, Savara had a carrying value of its debt of approximately $24.8 million and had cash, cash equivalents, and short-term investments of approximately $111.7 million. Under the current operating plan, the Company believes this is sufficient capital to fund planned operations into 2021.

Conference Call and Webcast

Savara will host a conference call today at 4:30 p.m. Eastern Time (ET)/1:30 p.m. Pacific Time (PT). Shareholders and other interested parties may access the conference 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 request the "Savara Inc." call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source

Approximately one hour after the call, a replay of the webcast will be available on Savara’s website for 30 days, and a telephone replay will be available through August 15, 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 10133438.