Vital Therapies Announces Third Quarter Financial Results
November 03 2016 - 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 third
quarter ended September 30, 2016.
Key Recent Developments
- Twenty subjects have been enrolled 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 acute alcoholic hepatitis (sAAH).
There are now 33 sites open for enrollment in VTL-308.
- Faheem Hasnain was appointed to the Company’s Board of
Directors. In conjunction with joining the board, Mr. Hasnain
has made a personal investment in shares of the Company. Most
recently Mr. Hasnain served as President, CEO and as a Director of
Receptos, Inc., which was purchased by Celgene Corporation for $7.8
billion in August 2015. Also, the Board of Directors has
formed a Commercialization Committee, chaired by Mr. Hasnain, to
formulate a commercial strategy in anticipation of a positive
outcome for its VTL-308 phase 3 clinical trial.
- Presented two posters and made related presentations at the
17th International Symposium on Albumin Dialysis in Liver Disease,
which took place mid-September in Rostock, Germany. The first
poster is titled "Hepatic Inflammation and Cellular Therapy."
The second poster is titled "VTL C3A Cell-Secreted Factors Reduce
In Vitro Hepatocellular Injury via Multiple Mechanisms." Both
posters and the related presentations can be found on the Company’s
web site.
- Raised net proceeds of $11.8 million through October 31, 2016
under an existing “at-the-market,” or ATM, sales agreement since
initiating the program in March 2016 and from a private placement
to the Company’s new director.
Third quarter 2016 Financial Results
Cash Position
Cash and cash equivalents at September 30, 2016,
totaled $68.1 million compared to $83.4 million at December 31,
2015. The Company believes its cash position is sufficient to
fund the Company through the first quarter of 2018.
Results of Operations
Three Months Ended September 30, 2016
The Company reported a net loss of $10.2 million
for the quarter ended September 30, 2016, which compared with a net
loss of $12.3 million for the same prior year period. This
resulted in a net loss attributable to common stockholders of $0.32
per share for the three months ended September 30, 2016, as
compared to a net loss of $0.51 per share for the corresponding
period in 2015, on both a basic and diluted basis. These per
share figures are based on weighted-average common shares
outstanding of 31,645,838 shares and 24,025,481 shares,
respectively, with the increase in common shares outstanding at
September 30, 2016 primarily resulting from the Company’s follow-on
offering in the fourth quarter of 2015 and from shares issued under
the Company’s ATM sales agreement.
Research and development expenses decreased to
$7.5 million during the three months ended September 30, 2016 as
compared to $9.6 million in the three months ended September 30,
2015. This was primarily due to a reduction in clinical trial
and related manufacturing and consulting costs in comparison to the
prior year period. General and administrative expenses were
$2.8 million for the three months ended September 30, 2016,
compared to $2.7 million in the prior year period.
Upcoming Investor
Conference
Additionally, the Company will be presenting at
the following investor conferences:
- The 25th Annual Credit Suisse Healthcare Conference on Tuesday,
November 8 at 9:00 AM Pacific in Scottsdale, AZ.
- The Stifel 2016 Healthcare Conference on Wednesday, November 16
at 12:45 PM Pacific 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 the presentation
will be available for replay following the conference.
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 1402125. 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
1402125.
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 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 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, and 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
Quarterly Report on Form 10-Q for the quarter ended September 30,
2016. 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) |
|
|
|
|
|
|
|
September 30,
2016 |
|
December 31,
2015 |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
68,088 |
|
|
$ |
83,416 |
|
|
Restricted cash,
prepaid expenses and other current assets |
|
1,376 |
|
|
|
1,672 |
|
|
Property and equipment,
net |
|
2,922 |
|
|
|
3,809 |
|
|
Other assets |
|
87 |
|
|
|
184 |
|
|
Total assets |
$ |
72,473 |
|
|
$ |
89,081 |
|
|
|
|
|
|
|
Accounts payable,
accrued expenses and other current liabilities |
$ |
4,630 |
|
|
$ |
6,655 |
|
|
Long-term
liabilities |
|
83 |
|
|
|
101 |
|
|
Stockholders'
equity |
|
67,760 |
|
|
|
82,325 |
|
|
Total liabilities and
stockholders' equity |
$ |
72,473 |
|
|
$ |
89,081 |
|
|
|
|
|
|
|
Vital Therapies, Inc. |
Condensed Consolidated Statements of Operations |
(unaudited and in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
Three Months
Ended September 30, |
|
Nine Months
Ended September 30, |
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
7,469 |
|
|
$ |
9,646 |
|
|
$ |
21,184 |
|
|
$ |
32,945 |
|
General and administrative |
|
2,770 |
|
|
|
2,689 |
|
|
|
8,257 |
|
|
|
9,286 |
|
Total operating
expenses |
|
10,239 |
|
|
|
12,335 |
|
|
|
29,441 |
|
|
|
42,231 |
|
Loss from
operations |
|
(10,239 |
) |
|
|
(12,335 |
) |
|
|
(29,441 |
) |
|
|
(42,231 |
) |
Other income |
|
61 |
|
|
|
35 |
|
|
|
206 |
|
|
|
67 |
|
Net loss |
$ |
(10,178 |
) |
|
$ |
(12,300 |
) |
|
$ |
(29,235 |
) |
|
$ |
(42,164 |
) |
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
$ |
(0.32 |
) |
|
$ |
(0.51 |
) |
|
$ |
(0.94 |
) |
|
$ |
(1.76 |
) |
Weighted-average common
shares |
|
|
|
|
|
|
|
outstanding, basic and diluted |
|
31,645,838 |
|
|
|
24,025,481 |
|
|
|
31,153,801 |
|
|
|
23,998,396 |
|
|
|
|
|
|
|
|
|
Contact:
Vital Therapies, Inc.
Al Kildani
Vice President, Investor Relations and Business Development
858-673-6840
akildani@vitaltherapies.com
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