Vital Therapies Announces First Quarter 2017 Financial Results
May 09 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 first
quarter ended March 31, 2017.
Key Recent Developments
- Sixty-seven subjects have been enrolled as of May 8 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).
There are now 46 sites open for enrollment in
VTL-308. The Company expects to report topline data around
mid-2018.
- Strengthened the financial condition of the Company through an
underwritten public offering in March. The Company sold 10.1
million shares at $4.00 per share in the offering, which closed in
March 2017 resulting in proceeds of $37.8 million after
underwriting discounts and commissions. 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.
First Quarter 2017 Financial Results
Cash Position
Cash and cash equivalents at March 31, 2017,
totaled $86.6 million compared to $60.0 million at December 31,
2016.
Results of Operations
Three Months Ended March 31, 2017
The Company reported a net loss of $12.6 million
for the three months ended March 31, 2017, which compared with a
net loss of $9.6 million for the same prior year period. This
resulted in a net loss of $0.39 per share for the three months
ended March 31, 2017, as compared to a net loss of $0.31 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 32,645,103 shares and 30,563,088
shares, respectively, with the increase in common shares
outstanding at March 31, 2017 attributable to shares issued under
the Company’s at-the-market sales agreement during 2016 and the
Company’s follow-on offering in the first quarter of 2017.
Research and development expenses increased to
$9.6 million for the three months ended March 31, 2017 as compared
to $6.9 million for the three months ended March 31, 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 $3.1 million for the three months
ended March 31, 2017 as compared to $2.8 million in the prior year
period.
Conference Call Details
Vital Therapies will host a conference call to
discuss these results and provide a corporate update tomorrow,
Wednesday, May 10, 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
14568675. 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
14568675.
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 or the timing of the release of the results from these
trials, or 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 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 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 March 31,
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) |
|
|
|
|
|
|
|
March 31, 2017 |
|
December 31,
2016 |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
86,636 |
|
$ |
59,991 |
|
Prepaid expenses and
other current assets |
|
1,666 |
|
|
1,472 |
|
Property and equipment,
net |
|
2,489 |
|
|
2,505 |
|
Other assets |
|
156 |
|
|
58 |
|
Total assets |
$ |
90,947 |
|
$ |
64,026 |
|
|
|
|
|
|
Accounts payable,
accrued expenses and other current liabilities |
$ |
6,450 |
|
$ |
5,480 |
|
Long-term
liabilities |
|
69 |
|
|
100 |
|
Stockholders'
equity |
|
84,428 |
|
|
58,446 |
|
Total liabilities and
stockholders' equity |
$ |
90,947 |
|
$ |
64,026 |
|
|
|
|
|
|
Vital Therapies, Inc. |
Condensed Consolidated Statements of Operations |
(unaudited and in thousands, except share and per share
data) |
|
|
|
|
|
|
Three Months
Ended March 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
Operating
expenses: |
|
|
|
|
Research
and development |
$ |
9,628 |
|
|
$ |
6,857 |
|
|
General
and administrative |
|
3,059 |
|
|
|
2,799 |
|
|
Total operating
expenses |
|
12,687 |
|
|
|
9,656 |
|
|
Loss from
operations |
|
(12,687 |
) |
|
|
(9,656 |
) |
|
Other income |
|
85 |
|
|
|
67 |
|
|
Net loss |
$ |
(12,602 |
) |
|
$ |
(9,589 |
) |
|
|
|
|
|
|
Net loss per share,
basic and diluted |
$ |
(0.39 |
) |
|
$ |
(0.31 |
) |
|
|
|
|
|
|
Weighted-average common
shares outstanding, basic and diluted |
|
32,645,103 |
|
|
|
30,563,088 |
|
|
|
|
|
|
|
Contact:
Vital Therapies, Inc.
Al Kildani
Vice President, Investor Relations and Business Development
858-673-6840
akildani@vitaltherapies.com
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