Vical Reports Fourth Quarter 2014 Financial Results and Progress in Key Development Programs
February 26 2015 - 6:30AM
Vical Incorporated (Nasdaq:VICL) today reported financial results
for the three months and twelve months ended December 31, 2014. Net
loss for the fourth quarter of 2014 was $4.6 million, or $0.05 per
share, compared with a net loss of $2.2 million, or $0.03 per
share, for the fourth quarter of 2013. Revenues for the fourth
quarter of 2014 were $4.8 million, compared with revenues of $3.1
million for the fourth quarter of 2013, reflecting higher revenues
from Astellas Pharma Inc. for development and manufacturing
services performed under our ASP0113 collaborative agreements.
ASP0113 is Vical's therapeutic vaccine designed to control
cytomegalovirus (CMV) reactivation in transplant recipients.
Vical had cash and investments of $49.1 million at December 31,
2014. The Company's net cash use for the fourth quarter of 2014 was
$2.7 million, which reflects its ongoing efforts to manage its
operating expenses. The Company's net cash use for 2014 was $10.3
million which was consistent with the Company's prior guidance. The
Company is projecting net cash use for 2015 between $12 million and
$15 million.
Program highlights include:
HSV-2 Vaccine
- Vical's Phase 1/2 trial of its therapeutic vaccine designed to
reduce viral shedding and reduce genital lesion recurrences in
herpes simplex virus type 2 (HSV-2) positive subjects is
progressing according to plan. Enrollment of patients in all of the
trial cohorts is now complete. The Company expects to release
top-line data by the middle of 2015. The 156 subject randomized,
double-blind, placebo-controlled trial will evaluate safety,
tolerability and efficacy in otherwise healthy HSV-2-infected
patients aged 18 to 50 years at seven U.S. clinical sites.
ASP0113 CMV Vaccine
- Astellas continues to enroll patients in Vical's partnered
ASP0113 clinical programs. ASP0113 is a therapeutic vaccine
designed to prevent CMV reactivation and infection in hematopoietic
stem cell transplant (HCT) recipients and solid organ transplant
subjects.
- The multinational Phase 2 trial in approximately 140 kidney
transplant recipients is enrolling rapidly and is currently
trending approximately 9 months ahead of plan. Astellas now
anticipates that enrollment in the trial may be completed in the
middle of 2015.
- The multinational Phase 3 registration trial in approximately
500 HCT recipients is proceeding according to plan, with enrollment
expected to be completed in late 2015.
Ebola Collaboration
- In January, Vical and AnGes MG announced that they had entered
into a collaboration to develop and commercialize an equine
polyclonal antibody therapy for patients afflicted with Ebola virus
disease. Vical will develop and provide to AnGes a DNA vaccine
encoding the glycoprotein antigen of the 2014 Zaire strain of Ebola
virus, formulated with Vical's proprietary Vaxfectin® adjuvant.
AnGes received the right to exclusively develop and commercialize
the equine polyclonal antibody therapy in Japan and will be
responsible for all development costs.
Conference Call
Vical will conduct a conference call and webcast today, February
26, at noon Eastern Time, to discuss the company's financial
results and program updates with invited participants. The call and
webcast are open on a listen-only basis to any interested parties.
To listen to the conference call, dial in approximately ten minutes
before the scheduled call to (719) 325-2244 (preferred), or (888)
438-5453 (toll-free), and reference confirmation code 8639391. A
replay of the call will be available for 48 hours beginning about
two hours after the call. To listen to the replay, dial (719)
457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay
passcode 8639391. The call also will be available live and archived
through the events page at www.vical.com. For further information,
contact Vical's Investor Relations department by phone at (858)
646-1127 or by e-mail at ir@vical.com.
About Vical
Vical researches and develops biopharmaceutical products
leveraging its patented DNA delivery technologies for the
prevention and treatment of chronic or life-threatening infectious
diseases. In addition, the company has collaborations with major
pharmaceutical and biotechnology companies focused on addressing
significant unmet medical needs. Additional information on Vical is
available at www.vical.com.
Forward-Looking Statements
This press release contains forward-looking statements subject
to risks and uncertainties that could cause actual results to
differ materially from those projected. Forward-looking statements
include net cash use guidance, as well as anticipated developments
in independent and collaborative programs, including the
recruitment and announcement of data for clinical trials. Risks and
uncertainties include whether Vical or others will continue
development of ASP0113, Vical's HSV-2 vaccine, Ebola antibody
therapy or any other independent or collaborative programs; whether
Vical will achieve levels of revenues and control expenses to meet
its financial projections; whether enrollment in on-going trials
will continue at current rates; whether any product candidates will
be shown to be safe and efficacious in clinical trials; the timing
of clinical trials; whether Vical or its collaborative partners
will seek or gain approval to market any product candidates; and
additional risks set forth in the company's filings with the
Securities and Exchange Commission. These forward-looking
statements represent the company's judgment as of the date of this
release. The company disclaims, however, any intent or obligation
to update these forward-looking statements.
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VICAL
INCORPORATED |
Selected Condensed
Financial Information (Unaudited) |
|
|
|
|
|
|
Three Months Ended |
Twelve Months Ended |
Statements of
Operations |
December 31, |
December 31, |
(in thousands, except per share amounts) |
2014 |
2013 |
2014 |
2013 |
Revenues: |
|
|
|
|
Contract and grant revenue |
$ 4,231 |
$ 2,230 |
$ 13,304 |
$ 5,846 |
License and royalty
revenue |
592 |
915 |
1,913 |
1,872 |
Total revenues |
4,823 |
3,145 |
15,217 |
7,718 |
Operating expenses: |
|
|
|
|
Research and development |
3,762 |
2,478 |
11,467 |
14,558 |
Manufacturing and
production |
3,367 |
1,194 |
10,824 |
12,698 |
General and administrative |
2,376 |
1,695 |
9,552 |
11,814 |
Total operating expenses |
9,505 |
5,367 |
31,843 |
39,070 |
Loss from operations |
(4,682) |
(2,222) |
(16,626) |
(31,352) |
Net investment and other
income |
49 |
30 |
134 |
114 |
Net loss |
$ (4,633) |
$ (2,192) |
$ (16,492) |
$ (31,238) |
Basic and diluted net loss per share |
$ (0.05) |
$ (0.03) |
$ (0.19) |
$ (0.36) |
Weighted average shares used in
computing basic and diluted net loss per share |
90,631 |
87,064 |
88,786 |
86,840 |
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|
|
|
|
|
|
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Balance Sheets |
|
|
December 31, |
December 31, |
(in thousands) |
|
|
2014 |
2013 |
Assets: |
|
|
|
|
Cash, cash equivalents, and
marketable securities, including restricted |
|
|
$ 47,152 |
$ 53,497 |
Other current assets |
|
|
4,178 |
4,590 |
Total current assets |
|
|
51,330 |
58,087 |
Long-term investments |
|
|
1,971 |
1,980 |
Property and equipment, net |
|
|
2,639 |
3,935 |
Other assets |
|
|
2,039 |
2,351 |
Total assets |
|
|
$ 57,979 |
$ 66,353 |
|
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
|
Current liabilities |
|
|
$ 5,201 |
$ 3,653 |
Long-term liabilities |
|
|
856 |
1,288 |
Stockholders' equity |
|
|
51,922 |
61,412 |
Total liabilities and stockholders'
equity |
|
|
$ 57,979 |
$ 66,353 |
CONTACT: Andrew Hopkins
(858) 646-1127
Website: www.vical.com
Anthony Ramos
Vice President and Chief Accounting Officer
Vical (NASDAQ:VICL)
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