Vital Therapies Announces Second Quarter 2017 Financial Results
August 03 2017 - 4:01PM
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, 2017.
Key Recent Developments
- Since the Company’s last quarterly update reported on May 9,
2017, enrollment has continued at a rate of about 9 subjects per
month at sites in the United States and Europe in VTL-308, the
Company’s phase 3 randomized, controlled, open-label trial,
designed to evaluate the ELAD System in subjects with severe
alcoholic hepatitis (sAH). As of August 2nd, 95 subjects were
enrolled in the trial with 49 sites open for enrollment. The
Company still expects to report topline data around mid-2018, most
likely in the third quarter.
- In June, the Company released data describing the baseline
characteristics of the first 67 subjects enrolled in VTL-308.
Today, the Company has updated that data to include the first 93
subjects. The data continue to show that no subjects outside
the enrollment criteria have been enrolled in VTL-308 to date, and
that the subject baseline characteristics are closely tracking the
reference subset 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(mg/dL) |
VTL-308 enrollment limits |
|
<50 yrs |
≤30 |
≥16 mg/dL |
≤2.5 |
<1.3mg/dL |
VTI-208 reference population(n=60) |
Mean (range) |
40.10 (28-49) |
25.60 (20-29) |
26.62 (16.6 - 52.6) |
1.86 (1.0 - 2.5) |
0.71 (0.10 -1.30) |
VTL-308(n=93) |
Mean (range) |
38.32 (23-49) |
25.23 (19-29) |
25.15 (16.0 - 42.8) |
1.83 (0.95 - 2.50) |
0.73 (0.36- 1.27) |
Second Quarter 2017 Financial Results
Cash Position
Cash and cash equivalents at June 30, 2017,
totaled $76.2 million compared to $60.0 million at December 31,
2016. The Company believes its current cash position could
provide funding through the first quarter of 2019, well past the
expected announcement of VTL-308 top-line trial results.
Results of Operations
Three Months Ended June 30, 2017
The Company reported a net loss of $12.4 million
for the three months ended June 30, 2017, which compared with a net
loss of $9.5 million for the same prior year period. This
resulted in a net loss of $0.29 per share for the three months
ended June 30, 2017, as compared to a net loss of $0.30 per share
for the corresponding period in 2016, on both a basic and diluted
basis. These per share figures are based on weighted-average
common shares outstanding of 42,207,376 shares and 31,247,069
shares, respectively, with the increase in common shares
outstanding at June 30, 2017 primarily attributable to shares
issued as part of the Company’s follow-on offering in the first
quarter of 2017.
Research and development expenses increased to
$9.8 million for the three months ended June 30, 2017 as compared
to $6.9 million for the three months ended June 30, 2016.
This was primarily due to an increase in clinical trial and related
costs in comparison to the prior year period. General and
administrative expenses were $2.7 million for both the three months
ended June 30, 2017 and 2016.
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 58660651. Participants can access the live
webcast via a link on the Vital Therapies website in the Investor
Relations section under the heading “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
58660651.
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 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 obtaining or maintaining regulatory approval in the
United States or Europe, in particular for a combination product
and open-label clinical trials; the timing of incurring costs for
activities to support our clinical trials and any applications for
marketing approval; whether or when we begin building any
significant commercial infrastructure; our limited experience in
conducting pivotal clinical trials and significant issues regarding
our clinical trials, including, but not limited to, the continued
participation of clinical sites and their ongoing adherence to
protocols; assumptions regarding the number of subjects to be
enrolled, enrollment rates, and the timing and availability of
subjects meeting inclusion and exclusion criteria; changes to
protocols or regulatory requirements; the need to comply with and
meet applicable laws and regulations; and unexpected adverse events
or safety issues. 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. 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, 2017. 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.
Vital Therapies, Inc. |
|
Condensed Consolidated Balance Sheets |
|
(unaudited, in thousands) |
|
|
|
|
|
|
|
June 30, 2017 |
|
December 31,
2016 |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
76,153 |
|
$ |
59,991 |
|
Prepaid expenses and
other current assets |
|
1,910 |
|
|
1,472 |
|
Property and equipment,
net |
|
2,430 |
|
|
2,505 |
|
Other assets |
|
182 |
|
|
58 |
|
Total assets |
$ |
80,675 |
|
$ |
64,026 |
|
|
|
|
|
|
Accounts payable,
accrued expenses and other |
|
|
|
|
current
liabilities |
$ |
7,292 |
|
$ |
5,480 |
|
Long-term
liabilities |
|
46 |
|
|
100 |
|
Stockholders'
equity |
|
73,337 |
|
|
58,446 |
|
Total liabilities and
stockholders' equity |
$ |
80,675 |
|
$ |
64,026 |
|
|
|
|
|
|
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, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
$ |
9,834 |
|
|
$ |
6,858 |
|
|
$ |
19,462 |
|
|
$ |
13,715 |
|
General
and administrative |
|
2,715 |
|
|
|
2,688 |
|
|
|
5,774 |
|
|
|
5,487 |
|
Total operating
expenses |
|
12,549 |
|
|
|
9,546 |
|
|
|
25,236 |
|
|
|
19,202 |
|
Loss from
operations |
|
(12,549 |
) |
|
|
(9,546 |
) |
|
|
(25,236 |
) |
|
|
(19,202 |
) |
Other income |
|
142 |
|
|
|
78 |
|
|
|
227 |
|
|
|
145 |
|
Net loss |
$ |
(12,407 |
) |
|
$ |
(9,468 |
) |
|
$ |
(25,009 |
) |
|
$ |
(19,057 |
) |
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
$ |
(0.29 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.67 |
) |
|
$ |
(0.62 |
) |
Weighted-average common
shares |
|
|
|
|
|
|
|
outstanding, basic and diluted |
|
42,207,376 |
|
|
|
31,247,069 |
|
|
|
37,452,655 |
|
|
|
30,905,079 |
|
|
|
|
|
|
|
|
|
Contact:
Vital Therapies, Inc.
Al Kildani
Vice President, Investor Relations and Business Development
858-673-6840
akildani@vitaltherapies.com
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