Vital Therapies Announces Fourth Quarter and Full Year 2017 Financial Results
- VTL-308 Enrollment Nears Completion with 147 Subjects Enrolled as of
- On Track for Release of Topline Results in Third Quarter of 2018
“As VTL-308 nears completion, I am proud of the job our team has done in designing and running this pivotal trial,” said
Key Recent Developments
- As of
March 12, 147 subjects were enrolled in VTL-308 with 43 sites open for enrollment. VTL-308 is the Company's phase 3 randomized, controlled, open-label trial, designed to evaluate the ELAD System in subjects with severe alcoholic hepatitis (sAH). This compares with 118 subjects enrolled and 45 sites open for enrollment as of the Company’s last quarterly update on October 25, 2017. As planned, during the first quarter of 2018, independent statisticians evaluated the blended event rate in the VTL-308 study as of December 31, 2017. These independent statisticians concluded that the overall event rate at such time was consistent with the trial’s original statistical plan, and therefore recommended the Company retain the trial’s original enrollment target of 150. The Company expects to complete enrollment this month and continues to anticipate reporting topline data in the third quarter of this year, likely in September.
- Today, the Company has updated the baseline characteristics of subjects enrolled in VTL-308 to include the first 147 subjects. The data continue to show that the means for these baseline characteristics continue to track the reference population from VTI-208, the Company’s prior phase 3 clinical trial with ELAD, in subjects with sAH on which the design of VTL-308 is based. The updated baseline data are presented in the table below:
|Data||Age (years)||MELD||Bilirubin (mg/dL)||INR||Creatinine
|VTL-308 enrollment limits||<50 yrs||<30||≥16 mg/dL||≤2.5||<1.3mg/dL|
|VTI-208 reference population
(28 - 49)
(20 - 29)
(16.6 - 52.6)
(1.0 - 2.5)
(0.10 - 1.30)
(23 - 49)
(19 - 29)
(16.0 – 44.7)
(0.95 – 2.50)
(0.30 - 1.27)
December 4ththe Company announced the appointment of Russell J. Coxas Chief Executive Officer, succeeding Terry Winters, Ph.D., who remains a consultant to the Company. Previously Mr. Cox served as the Executive Vice President and Chief Operating Officer of Jazz Pharmaceutical plc(Nasdaq: JAZZ) from May 2014, with responsibility for U.S., EU and rest-of-world commercial activities, research and development, manufacturing / technical operations, new product planning and global molecule leadership. Prior to that, Mr. Cox served in multiple senior management roles at Jazz, which he joined in 2010. During Mr. Cox’s tenure, Jazz Pharmaceuticalssaw its total revenue grow from under $200 millionannually to more than $1.6 billionin 2017, and was recognized by Fortune magazinein 2013 and 2017 as one of the fastest growing companies traded on a major U.S. stock exchange. Previously, Mr. Cox served as Senior Vice President and Chief Commercial Officer of Ipsen Group, a pharmaceutical company, from January 2009to January 2010. From 2007 until December 2008, he was Vice President of Marketing at Tercica, Inc.prior to its acquisition by Ipsen Group. From 2003 to 2007, he served as Vice President, Marketing with Scios Inc., which was acquired by Johnson & Johnsonin 2003. Previously, Mr. Cox spent 12 years with Genentech, Inc.where he was a Product Team Leader responsible for the Growth Hormone franchise and led numerous product launches as a Group Product Manager.
- A paper titled “Extracorporeal Cellular Therapy (ELAD) in Severe Alcoholic Hepatitis: A Multinational, Prospective, Controlled, Randomized Trial” was published in the March issue of the peer-reviewed journal Liver Transplantation. The paper reviews the Company’s VTI-208 phase 3 study, which reported topline results in August 2015. Although VTI-208 failed to meet its primary or secondary endpoints, trends identified in pre-specified and post-hoc subset analyses of the study formed the basis for the trial design of VTL-308. Specifically, as discussed in the paper, ELAD may have a benefit in younger subjects (<50 years old) with sufficient renal function (creatinine <1.3 mg/dL) and less severe coagulopathy (INR≤2.5). The paper can be accessed via the Liver Transplantationwebsite.
- The Company continues to present findings from its research into the mechanism of action of ELAD at scientific conferences. An abstract titled “Hepatoprotective Biomarkers, Amphiregulin and Soluble Fas, Increase During ELAD Treatment in Alcoholic Hepatitis Subjects” was accepted for poster presentation at
The International Liver Congress(sponsored by the European Association for the Study of the Liver, or EASL), to be held April 11-15, 2018in Paris, France. An abstract titled “Inflammation Biomarkers Decrease During ELAD Treatment in Alcoholic Hepatitis Subjects” was accepted for poster presentation at Digestive Disease Week to be held June 2-5, 2018in Washington, D.C. Posters and associated presentations are made available at http://ir.vitaltherapies.com in the " Clinical Publicationsand Presentations" section promptly after they have been presented publicly.
Fourth Quarter 2017 Financial Results
Cash and cash equivalents at
Results of Operations
Three Months Ended
The Company reported a net loss of
Research and development expenses increased to
The Company will be presenting at the
Conference Call Details
For those unable to listen in at the designated time, a conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 7392256.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying the timing and conduct of our clinical trials and the timing of the release of the results from these trials, and statements regarding our projected cash runway. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
Risks and uncertainties include, but are not limited to, difficulty maintaining regulatory approvals in
These and other risks regarding our business are described in detail in our
Vice President, Investor Relations and Business Development
|Vital Therapies, Inc.|
|Condensed Consolidated Balance Sheets|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||56,901||$||59,991|
|Other current assets and prepaid expenses||1,220||1,472|
|Property and equipment, net||2,155||2,505|
|Accounts payable, accrued expenses and other current liabilities||$||10,281||$||5,480|
|Total liabilities and stockholders' equity||$||60,384||$||64,026|
|Vital Therapies, Inc.|
|Condensed Consolidated Statements of Operations|
|(unaudited and in thousands, except per share data)|
|Ended December 31,||Ended December 31,|
|Research and development||$||10,190||$||8,862||$||39,341||$||30,046|
|General and administrative||4,590||2,963||13,314||11,220|
|Total operating expenses||14,780||11,825||52,655||41,266|
|Loss from operations||(14,780||)||(11,825||)||(52,655||)||(41,266||)|
|Net loss per share, basic and diluted||$||(0.35||)||$||(0.37||)||$||(1.31||)||$||(1.31||)|
|Weighted-average common shares|
|outstanding, basic and diluted||42,244,880||32,083,830||39,859,009||31,387,579|
Source: Vital Therapies, Inc.