Vital Therapies Announces Second Quarter 2018 Financial Results
07 Agosto 2018 - 5:01PM
Vital Therapies, Inc. (Nasdaq: VTL), a biotherapeutic company
developing ELAD®, a cell-based therapy targeting the treatment of
acute forms of liver failure, today announced results for the
second quarter ended June 30, 2018.
“This is an exciting time for the Company. We
are diligently working toward database lock for VTL-308 and expect
to report topline results in the second half of September,” said
Russell J. Cox, the Company’s Chief Executive Officer.
“Additionally, we continue with preparations for the potential
submission of a biologics license application and commercial launch
of ELAD.”
Key Recent Developments
- The Company expects to report topline data from its VTL-308
pivotal clinical trial in the second half of September 2018.
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). VTL-308 completed enrollment at the end
of March 2018 with 151 subjects (78 in ELAD-treated arm, 73 in
control arm) enrolled at 38 sites in the United States and European
Union.
- On May 24, 2018 the Company hosted an Analyst R&D Day with
presentations focused on the disease state of sAH and ELAD’s
hypothesized mechanism of action. In addition to members of the
Vital Therapies team, two external clinical experts in the field of
alcoholic hepatitis presented: Dr. Stephen R. Atkinson, Specialist
Registrar in Gastroenterology and Hepatology and an Honorary
Clinical Lecturer at Imperial College London; and Dr. Nikolaos T.
Pyrsopoulos Chief of Gastroenterology and Hepatology, Rutgers New
Jersey Medical School. An archive of the webcast for this event
along with an accompanying slide presentation can be found in the
Investor Relations section of the Company’s website at
http://ir.vitaltherapies.com/.
- On June 25, 2018 the Company announced it was added as a member
of the broad-market Russell 3000® Index, as part of the 2018
Russell indexes reconstitution. Membership in the Russell 3000®
Index, which remains in place for one year, means automatic
inclusion in the small-cap Russell 2000® Index as well as the
appropriate growth and value style indexes. FTSE Russell determines
membership for its Russell U.S. Indexes primarily by objective
market-capitalization rankings and style attributes.
Second Quarter 2018 Financial
Results
Cash Position
Cash and cash equivalents at June 30, 2018,
totaled $31.1 million compared to $56.9 million at December 31,
2017. The Company expects its use of funds will change based on the
results of the VTL-308 clinical trial.
Results of Operations
Three Months Ended June 30, 2018
The Company reported a net loss of $12.7 million
for the three months ended June 30, 2018, which compared with a net
loss of $12.4 million for the same prior year period. This resulted
in a net loss of $0.30 per share for the three months ended June
30, 2018, as compared to a net loss of $0.29 per share for the
corresponding period in 2017, on both a basic and diluted
basis.
Research and development expenses decreased to
$8.7 million for the three months ended June 30, 2018 as compared
to $9.8 million for the three months ended June 30, 2017. General
and administrative expenses were $4.3 million for the three months
ended June 30, 2018, as compared to $2.7 million for the three
months ended June 30, 2017.
Conference Call Details
Vital Therapies will host a conference call to
discuss these results and provide a corporate update today at 4:30
PM ET, which will be open to the public. The conference call
dial-in numbers are (855) 765-5682 for domestic callers and (919)
825-3204 for international callers. The conference ID number for
the call is 9287366. Participants can access the live webcast via a
link on the Vital Therapies website in the Investor Relations
section under “Events” at: http://ir.vitaltherapies.com/.
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
9287366.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic
company developing a cell-based therapy targeting the treatment of
acute forms of liver failure. The Company’s ELAD System is an
extracorporeal human allogeneic cellular liver therapy currently in
phase 3 clinical trials. Vital Therapies, Inc. is based in San
Diego, California. Vital Therapies® and ELAD® are trademarks of
Vital Therapies, Inc.
Forward-Looking Statements
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 our cash
use. 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 the
United States or Europe, in particular for a combination product
and open-label clinical trials; our limited experience in
conducting pivotal clinical trials and significant issues regarding
our clinical trials such as clinical sites’ adherence to protocols;
assumptions regarding the number of subjects enrolled; changes to
regulatory requirements; the need to comply with and meet
applicable laws and regulations; unexpected adverse events or
safety issues; event rates may vary from projections; whether
additional clinical trials will be required by regulatory
authorities; and the use of cash and having adequate funding, which
can vary based on the timing of incurring costs for activities to
support our clinical development and any applications for marketing
approval, and whether or when the Company begins building any
significant commercial infrastructure. There can be no assurance
that data from any of our clinical trials will be sufficient to
support an application for marketing in any country or that any
such application will ever be approved or that the Company will be
able to raise additional funding on reasonable terms or at all.
These and other risks regarding our business are
described in detail in our Securities and Exchange Commission
filings, including in our Annual Report on Form 10-Q for the
quarter ended June 30, 2018. These forward-looking statements speak
only as of the date hereof, and Vital Therapies, Inc. disclaims any
obligation to update these statements except as may be required by
law.
Contact: Vital Therapies, Inc. Al KildaniVice President,
Investor Relations and Business Development
858-673-6840akildani@vitaltherapies.com
|
Vital Therapies, Inc. |
Condensed Consolidated Balance Sheets |
(unaudited, in thousands) |
|
|
|
|
|
June 30, 2018 |
|
December 31,
2017 |
|
|
|
|
Cash and
cash equivalents |
$ |
31,116 |
|
$ |
56,901 |
Prepaid
expenses and other current assets |
|
1,529 |
|
|
1,220 |
Property
and equipment, net |
|
2,059 |
|
|
2,155 |
Other
assets |
|
97 |
|
|
108 |
Total
assets |
$ |
34,801 |
|
$ |
60,384 |
|
|
|
|
Accounts
payable, accrued expenses and other current liabilities |
$ |
8,299 |
|
$ |
10,281 |
Long-term liabilities |
|
49 |
|
|
59 |
Stockholders' equity |
|
26,453 |
|
|
50,044 |
Total
liabilities and stockholders' equity |
$ |
34,801 |
|
$ |
60,384 |
|
|
|
|
|
Vital Therapies, Inc. |
Condensed Consolidated Statements of Operations |
(unaudited and in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30, |
|
Six Months
Ended June 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Operating expenses: |
|
|
|
|
|
|
|
Research
and development |
$ |
8,660 |
|
|
$ |
9,834 |
|
|
$ |
18,817 |
|
|
$ |
19,462 |
|
General
and administrative |
|
4,257 |
|
|
|
2,715 |
|
|
|
8,592 |
|
|
|
5,774 |
|
Total
operating expenses |
|
12,917 |
|
|
|
12,549 |
|
|
|
27,409 |
|
|
|
25,236 |
|
Loss
from operations |
|
(12,917 |
) |
|
|
(12,549 |
) |
|
|
(27,409 |
) |
|
|
(25,236 |
) |
Other
income |
|
235 |
|
|
|
142 |
|
|
|
339 |
|
|
|
227 |
|
Net
loss |
$ |
(12,682 |
) |
|
$ |
(12,407 |
) |
|
$ |
(27,070 |
) |
|
$ |
(25,009 |
) |
|
|
|
|
|
|
|
|
Net loss
per share, basic and diluted |
$ |
(0.30 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.64 |
) |
|
$ |
(0.67 |
) |
|
|
|
|
|
|
|
|
Weighted-average common shares |
|
|
|
|
|
|
|
outstanding, basic and diluted |
|
42,368,973 |
|
|
|
42,207,376 |
|
|
|
42,368,919 |
|
|
|
37,452,655 |
|
|
|
|
|
|
|
|
|
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