Savara Reports First Quarter 2018 Financial Results and Provides Business Update
- Molgradex Phase 3 IMPALA study enrollment on track for completion in Q3 2018
- AeroVanc Phase 3 AVAIL study enrollment on track for completion in Q1 2019
- Molgradex Phase 2a
OPTIMAstudy enrollment on track for completion in Q3 2018
- First patient enrolled in Molgradex IMPALA-X safety extension study
- Conference call scheduled for today at
5:30 p.m. E.T.
“It has been an incredibly productive quarter, including the launch of two new clinical studies,
Upcoming Milestones and Recent Developments
- Anticipating completion of enrollment in the Molgradex Phase 3 IMPALA study in Q3 2018. The IMPALA study is evaluating our inhaled formulation of granulocyte-macrophage colony-stimulating factor, or GM-CSF, for the treatment of autoimmune pulmonary alveolar proteinosis, or aPAP. At the end of Q1, enrollment was at 96 patients out of a total target of 135 patients, with completion of enrollment currently on track for Q3 2018 and topline data anticipated in Q2 2019.
- Anticipating completion of enrollment in the AeroVanc Phase 3 AVAIL study in Q1 2019. The AVAIL study is evaluating our vancomycin hydrochloride inhalation powder for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in individuals living with cystic fibrosis. At the end of Q1, enrollment was at 62 patients out of a total target of 200 patients, with completion of enrollment currently on track for Q1 2019 and topline data anticipated in H2 2019.
- Anticipating completion of enrollment in the Molgradex Phase 2a
OPTIMAstudy in Q3 2018. The OPTIMAstudy is evaluating our inhaled GM-CSF for the treatment of nontuberculous mycobacterial (NTM) lung infection. The study was initiated in mid-March 2018and is expected to be completed in Q3 2018. As OPTIMAis an open-label study, depending on enrollment and other factors, interim results from the study may be provided during 2018.
- Announcing first patient enrolled in the Molgradex IMPALA-X safety extension study. The IMPALA-X study is an open-label, multicenter study designed to determine the long-term safety and utilization of Molgradex in patients with aPAP. IMPALA-X offers patients the opportunity to continue treatment with Molgradex for up to three years after completion of the pivotal Phase 3 IMPALA study. Savara plans to initiate the IMPALA-X study in a rolling fashion in 12 of the countries participating in the IMPALA study by the end of 2018.
First Quarter Financial Results
Savara’s net loss attributable to common shareholders for the three months ended
Research and development expenses were $8.5 million for the three months ended
General and administrative expenses for the three months ended
Also, during the three months ended
We reported a
As of March 31, 2018, Savara had cash, cash equivalents and short-term investments of approximately $85.0 million. The company's operating expenses for the first quarter of 2018 were approximately $32.1 million which included the one-time noncash impairment charge of
Conference Call and Webcast
Savara will hold a conference call today beginning at 5:30 p.m. Eastern Time / 4:30 p.m. Central Time to provide a business update. 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 should request the Savara Inc. call. A live webcast of the conference call will be available online from the Investors section of Savara's website at http://www.savarapharma.com/investors/events/. Replays of the webcast will be available on Savara's website for 30 days and a telephone replay will be available through May 16th, 2018 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada, and (412) 317-0088 from elsewhere outside the U.S. by entering replay access code 10119917.
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements relating to our focus for the remainder of the year being on the continued advancement of our core programs and actively exploring further expansion of our pipeline, the timing of topline data or interim results and completion of enrollment of our Molgradex Phase 3 IMPALA, AeroVanc Phase 3 AVAIL and Molgradex Phase 2a
For IR: Solebury Trout
For Media: Neon Interactive
Tables to follow
|Savara Inc. and Subsidiaries|
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three months ended|
|Research and development||8,539||2,948|
|General and administration||1,769||1,736|
|Impairment of acquired IPR&D||21,692||-|
|Total operating expenses||32,107||4,774|
|Loss from operations||$||(32,107||)||$||(4,774||)|
|Interest and other (expense)/income, net||(221||)||(437||)|
|Loss before income taxes||$||(32,328||)||$||(5,211||)|
|Income tax benefit||5,479||237|
|Other expenses attributable to common shareholders||-||(24||)|
|Net loss attributable to common shareholders||$||(26,849||)||$||(4,998||)|
|Net loss per share - basic and diluted||$||(0.88||)||$||(1.65||)|
|Weighted average common shares - basic and diluted||30,543,746||3,029,223|
|Savara Inc. and Subsidiaries|
|Balance Sheet data|
|March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||84,984||$||94,313|