Vital Therapies Announces Second Quarter 2014 Financial Results and Provides Update on Operations and Upcoming Conference Presentations
"In the second quarter, we completed our initial public offering and continued enrollment in our lead Phase 3 clinical trial in alcohol-induced liver decompensation, which is on track to deliver preliminary data in the first half of 2015," said
Recent Operational Highlights
Enrolled 138 subjects as of
August 5, 2014, in VTI-208, a phase 3 randomized, controlled trial, evaluating the ELAD® System, the Company's experimental bio-artificial liver, in 200 subjects with alcohol-induced liver decompensation. There are 49 clinical sites in the United States, Europeand Australiacurrently open for enrollment.
Opened 5 sites for enrollment as of
August 5, 2014, in VTI-210, a Phase 3 randomized, controlled clinical trial in at least 150 subjects with severe acute alcoholic hepatitis.
Enrolled the first subject in VTI-212, a Phase 2 single-arm clinical trial in 40 subjects with fulminant hepatic failure, or FHF, and surgery-induced acute liver failure, or SILF.
Received detailed guidance from the
Scientific Advice Working Party(SAWP) of the European Medicines Agency(EMA) on the production and testing section of a future European Marketing Authorization Application (MAA) and on aspects of the Phase 3 VTI-210 protocol design.
The Company continues to expect the release of preliminary data from VTI-210 in 2016 and from VTI-212 in 2015 or 2016.
Upcoming Investor Conferences
The Company will be presenting at the following upcoming investor conferences:
Wedbush PacGrow Life Sciences 2014
Life Sciences Management Access Conferenceat 1:55PM ET, on Tuesday, August 12, 2014in New York.
Canaccord Genuity Growth Conferenceat 9:00 AM ET, on Wednesday, August 13, 2014in Boston.
A live webcast of the Company's presentation at the
The webcast will be archived for approximately two weeks following the live presentation.
Second Quarter 2014 Financial Results
Cash and cash equivalents at
Based on its current business plan, the Company believes its existing cash and cash equivalents as of
Results of Operations
Three Months Ended
The Company reported a net loss for the quarter ended
Total operating expenses for the three months ended
The net loss for the three months ended
Six Months Ended
The Company reported a net loss for the six months ended
Total operating expenses for the first six months of 2014 were $23.5 million as compared to $12.0 million for the comparable period of 2013. Research and development expenses were $18.3 million for the first six months of 2014, as compared to $8.0 million for the same period of 2013. The
The net loss for the six months ended
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements concerning our future financial performance, our ability to undertake certain development activities such as clinical trial enrollment, the conduct of our clinical trials and the timing of data release and the accomplishment of certain development goals. Forward-looking statements are based on management's current, preliminary expectations and are subject to various risks and uncertainties that could cause actual results to differ materially from currently anticipated results. These forward-looking statements do not constitute guarantees of future performance. Risks and uncertainties with respect to our clinical trials include but are not limited to the successful opening and the
continued participation of clinical sites and their ongoing adherence to protocols, assumptions regarding enrollment rates, timing and availability of subjects meeting inclusion and exclusion criteria, changes to protocols or regulatory requirements, the ability to comply with and meet applicable laws and regulations, unexpected adverse events or safety issues and the sufficiency of funding. These and other risks regarding our financial position and research and development programs are contained in our Registration Statement on Form S-1 which was declared effective on
|Condensed Consolidated Balance Sheets|
|(unaudited, in thousands)|
|Cash and cash equivalents||$ 90,840||$ 38,186|
|Other current assets||2,649||5,669|
|Property and equipment, net||3,264||2,467|
|Total assets||$ 97,016||$ 46,585|
|Accounts payable and other accrued liabilities||$ 7,561||$ 4,846|
|Future purchase rights liabilities||--||2,600|
|Convertible preferred stock||--||83,475|
|Stockholders' equity (deficit)||89,163||(44,657)|
|Total liabilities and stockholders' equity (deficit)||$ 97,016||$ 46,585|
|Condensed Consolidated Statements of Operations|
|(unaudited and in thousands, except per share data)|
|Three Months||Six Months|
|Research and development||$ 9,125||$ 4,538||$ 18,345||$ 7,970|
|General and administrative||2,513||2,525||5,170||4,019|
|Total operating expenses||11,638||7,063||23,515||11,989|
|Loss from operations||(11,638)||(7,063)||(23,515)||(11,989)|
|Revaluation of future purchase rights liabilities and other income (expense), net||1,471||919||2,600||(3,513)|
|Accretion to redemption value and deemed dividend on preferred stock||(6,084)||(1,123)||(9,154)||(2,096)|
|Net loss attributable to common stockholders||$ (16,251)||$ (7,267)||$ (30,069)||$ (17,598)|
|Net loss per share attributable to common stockholders, basic and diluted||$ (0.91)||$ (14.33)||$ (3.24)||$ (36.12)|
|Weighted-average common shares outstanding, basic and diluted||17,888,171||507,055||9,273,672||487,221|
Terry WintersCo-Chairman & Chief Executive Officer Duane NashChief Business Officer Vital Therapies, Inc.858-673-6840
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