Savara Reports Third Quarter 2017 Financial Results and Provides Business Update
- Anticipating complete enrollment in the Molgradex Phase 3 IMPALA study in Q1 2018
- Initiating Phase 2a study of Molgradex for the treatment of NTM in early 2018
- Expecting top-line results from the Aironite Phase 2 INDIE study in H1 2018
Conference call scheduled for today at
5:30 p.m. E.T.
Recent Developments and Upcoming Milestones
- Anticipating complete enrollment in the Molgradex Phase 3 IMPALA study in Q1 2018. The IMPALA study is evaluating an inhaled formulation of granulocyte-macrophage colony-stimulating factor, or GM-CSF, for the treatment of pulmonary alveolar proteinosis, or PAP. More than 70% of the required 90 patients have been enrolled, with enrollment expected to be completed in Q1 2018 and top-line data anticipated by the end of 2018.
- Initiate Phase 2a study of Molgradex for the treatment of NTM in early 2018 . Scientific literature suggests that GM-CSF plays an important role in enhancing the ability of macrophages to clear mycobacteria and that targeting the human immune response, not bacteria directly, provides a promising new treatment approach that can avoid the increasing problem of antibiotic resistance. The Phase 2a open-label clinical trial, expected to begin in early 2018, will investigate the efficacy of Molgradex on NTM sputum culture conversion to negative, reduction of NTM bacterial load in sputum, exercise capacity as well as its effect on patient reported outcomes, and safety.
Expecting top-line results from the Aironite Phase 2 INDIE study in H1 2018. The INDIE study is evaluating inhaled sodium nitrite in heart failure with preserved ejection fraction, or HFpEF. In
October 2017, we announced that enrollment had been completed. The study is being conducted by the Heart Failure Clinical Trial Network with grant support from the NHLBI.
- Our common stock was uplisted to the Nasdaq Global Select Market® which has the highest initial listing standards of any of the world's stock markets.
Successfully closed a follow-on public offering with net proceeds to us of approximately
$50 millionwhich will help to fund the indication expansion of Molgradex for the treatment of NTM, our ongoing programs and growth strategy.
"It has been an incredibly productive third quarter for us on a number of fronts as we have executed on our key programs and our growth strategy on our journey to build Savara into a leading orphan lung disease company," stated
Third Quarter Financial Results
Savara's net loss attributable to common shareholders for the three months ended
Research and development expenses were
General and administrative expenses for the three-months ended
Conference Call and Webcast
Savara will hold a conference call today beginning at
Forward Looking Statements
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 the timing of top-line data and completion of enrollment of our Molgradex Phase 3 IMPALA study, initiating our Phase 2a study of Molgradex for the treatment of NTM in early 2018, the timing of top-line results from the Aironite Phase 2 INDIE study in H1 2018, the offering proceeds helping to fund the indication expansion of Molgradex for the treatment of NTM, our ongoing programs and growth strategy, our journey to build Savara into a leading orphan lung disease company, our belief the company is sufficiently funded to execute our current business plan into 2020, our strategy and our goals. Savara may not actually achieve any of the matters referred to in such forward looking statements, and you should not place undue reliance on these forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the outcome of our ongoing clinical trials for our product candidates, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs, the ability to obtain the necessary patient enrollment for our product candidates in a timely manner, the ability to successfully develop our product candidates, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as Molgradex, AeroVanc and Aironite that are safe and effective for use as human therapeutics and the timing and ability of Savara to raise additional equity capital if needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the
Tables to follow
|Savara Inc. and Subsidiaries|
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share data)|
|Three months ended||Nine months ended|
|September 30,||September 30,|
|Total net revenue||$||-||$||-||$||-||$||-|
|Research and development||4,966||2,142||12,076||4,694|
|General and administration||1,486||1,002||8,410||1,955|
|Depreciation and amortization||91||86||272||256|
|Total operating expenses||6,543||3,230||20,758||6,905|
|Loss from operations||$||(6,543||)||$||(3,230||)||$||(20,758||)||$||(6,905||)|
|Interest and other (expense)/income, net||(391||)||3||(3,359||)||(50||)|
|Loss before income taxes||$||(6,934||)||$||(3,227||)||$||(24,117||)||$||(6,955||)|
|Income tax benefit||117||-||824||-|
|Other expenses attributable to common shareholders||-||(44||)||(982||)||(70||)|
|Net loss attributable to common shareholders||$||(6,817||)||$||(3,271||)||$||(24,275||)||$||(7,025||)|
|Net loss per share - basic and diluted||$||(0.28||)||$||(1.21||)||$||(1.76||)||$||(4.40||)|
|Weighted average shares - basic and diluted||24,209,517||2,707,055||13,770,032||1,596,123|
|Savara Inc. and Subsidiaries|
|Balance Sheet data|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||53,286||$||13,373|
|Redeemable convertible preferred stock||-||43,861|
|Stockholders equity (deficit)||74,645||(35,875||)|
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