Vital Therapies Announces First Quarter 2018 Financial Results
- VTL-308 Enrollment Completed with 151 Subjects
- On Track for Release of Topline Results in Third Quarter of 2018
“We are pleased to have completed enrollment in our VTL-308 clinical trial and we have met both our timeline and our targeted treatment enrollment criteria. We anticipate reporting topline results in September,” said
Key Recent Developments
- VTL-308 completed enrollment at the end of March with 151 subjects enrolled. 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). The Company expects to report topline data in the third quarter of this year, likely in September.
- The Company has updated the baseline characteristics of subjects enrolled in VTL-308 to include current data for 151 subjects. The data show that the means for these baseline characteristics continued 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)
- The Company continues to present findings from its research into the mechanism of action of ELAD and potential other applications for the technology at scientific conferences. 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. An abstract titled “Impact of ELAD C3A Cell Conditioned Medium Enhanced Perfusate Fluid on Functional Recovery of Extended Criteria Donor Livers during Normothermic Machine Perfusion” was accepted for poster presentation at both the International Liver Transplantation Society2018 Annual Congress, to be held May 23-26in Lisbon, Portugal, and the 2018 Annual Transplant Congress, to be held June 2-6in Seattle, Washington. 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.
First Quarter 2018 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
Upcoming Investor Conferences
The Company will be presenting at the following upcoming conferences:
The Bank of America Merrill Lynch2018 Health Care Conferenceon Thursday, May 17, 2018at 1:15 PMEastern in Las Vegas, NV.
Jefferies2018 Global Healthcare Conference on Friday, June 8, 2018at 8:30 AMEastern in New York City.
A live webcast of each presentation will be available on the Investor Relations page of the Company's website at: http://ir.vitaltherapies.com/. An archive of each presentation will be available for replay following the conference.
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 5845687.
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 conduct of our clinical trials and the timing of the release of the results, 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||$||43,647||$||56,901|
|Prepaid expenses and other current assets||1,188||1,220|
|Property and equipment, net||2,072||2,155|
|Accounts payable, accrued expenses and other current liabilities||$||9,666||$||10,281|
|Total liabilities and stockholders' equity||$||47,008||$||60,384|
|Vital Therapies, Inc.|
|Condensed Consolidated Statements of Operations|
|(unaudited and in thousands, except share and per share data)|
Ended March 31,
|Research and development||$||10,157||$||9,628|
|General and administrative||4,335||3,059|
|Total operating expenses||14,492||12,687|
|Loss from operations||(14,492||)||(12,687||)|
|Net loss per share, basic and diluted||$||(0.34||)||$||(0.39||)|
|Weighted-average common shares|
|outstanding, basic and diluted||42,368,864||32,645,103|
Source: Vital Therapies, Inc.