On May 9, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported financial results for the first quarter ending March 31, 2019 and provided a business update (Press release, Savara, MAY 9, 2019, View Source [SID1234536174]).
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"We are diligently preparing for the highly anticipated readout of our Phase 3 IMPALA study in June, which we expect to be followed by the submission of a Biologics License Application in the first half of 2020 and, if approved, a commercial launch of Molgradex later in 2020 or early 2021," said Rob Neville, Chief Executive Officer, Savara. "These pivotal results could be transformational for the Company and, more importantly, for patients with aPAP, a rare and progressive lung disease. Our commitment to improving the lives of people with orphan lung diseases, and accelerating the advancement of our innovative therapies, is unwavering. With multiple catalysts expected over the coming quarters, we are well positioned for sustained growth."
Recent Developments and Upcoming Highlights
Molgradex for aPAP
Expect top line results from the IMPALA study in June 2019. IMPALA is a global, pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of aPAP. Positive results would facilitate the submission of a Biologics License Application in the first half of 2020, with an anticipated commercial launch later in 2020 or early 2021.
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. At the end of Q1 2019, 25 out of 26 eligible patients had enrolled in the extension study.
Molgradex received Fast Track Designation by the FDA for the treatment of aPAP. A drug granted with this designation may be eligible for Priority and/or Rolling Review, if relevant criteria are met.
Molgradex for nontuberculous mycobacterial (NTM) lung infection
Initiated ENCORE, a Phase 2a clinical study of Molgradex for the treatment of NTM in people living with cystic fibrosis (CF).
Expect top line results from OPTIMA, a Phase 2a clinical study evaluating Molgradex for the treatment of NTM in non-CF patients in Q1 2020.
Molgradex manufacturing
Entered into a new commercial manufacturing and supply agreement with GEMA Biotech, the company that has produced the drug substance for all Molgradex non-clinical and clinical studies. Under the terms of the agreement, GEMA Biotech will exclusively supply the Company with GM-CSF expressed from Savara’s proprietary cell line.
AeroVanc
Enrollment continues in AVAIL, a pivotal, global Phase 3 clinical study of AeroVanc, an inhaled vancomycin hydrochloride powder for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF.
As of today, the study has enrolled 153 patients out of a target of 200. An approximate 50% screen failure rate with younger subjects (between 6-21 years of age) has slowed enrollment. The screen failures are largely due to exacerbations between time of screening and randomization.
Expect to complete patient enrollment in Q3 2019 with top line results in Q2 2020.
Exploratory Pipeline
The initial indication for the Phase 2-ready aerosolized amikacin/fosfomycin combination antibiotic will focus on non-CF bronchiectasis patients with chronic lung infection and frequent exacerbations. A Phase 2 study is expected to start enrolling in bronchiectasis patients with recurrent exacerbations later in 2019 or early 2020 and will evaluate amikacin/fosfomycin and Molgradex separately, and in combination, to reduce bacterial infection load.
First Quarter Financial Results (Unaudited)
Savara’s net loss attributable to common stockholders for the three months ended March 31, 2019 was $12.1 million, or $(0.34) per share, compared with a net loss attributable to common stockholders of $26.8 million, or $(0.86) per share, for the three months ended March 31, 2018.
Research and development expenses were $10.0 million for the three months ended March 31, 2019, compared with $8.5 million for the three months ended March 31, 2018. The increase was primarily due to $1.9 million in increased development costs associated with the development of Molgradex, partially offset by a slight decrease in other program costs for the three months ended March 31, 2019.
General and administrative expenses for the three months ended March 31, 2019 were $2.8 million, compared with $1.8 million for the three months ended March 31, 2018. The increase was primarily due to increased personnel costs and other legal, accounting, insurance and operating activities.
As noted in the first quarter 2018 10-Q, during the quarter ended March 31, 2018, the Company recognized a $21.7 million impairment charge to the carrying value of acquired IPR&D related to a drug candidate previously assumed by Savara. For the first quarter ended March 31, 2019, there were no costs associated with this activity as the Company was no longer supporting or pursuing the drug candidate
.
Other income, net of other expense, increased by $0.1 million to $0.8 million for the three months ended March 31, 2019 from $0.7 million for the three months ended March 31, 2018 and was primarily related to a reduction of net interest expense.
Income tax benefit decreased by $4.5 million for the three months ended March 31, 2019 from the three months ended March 31, 2018 primarily due to the reversal of a deferred tax liability resulting from the impairment of certain acquired IPR&D during the first quarter of 2018.
As of March 31, 2019, Savara had a carrying value of its debt of approximately $24.7 million and had cash, cash equivalents, and short-term investments of approximately $105.2 million.
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 May 16, 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 10130971.