Vical Reports Fourth Quarter 2016 Financial Results
March 09 2017 - 6:30AM
Vical Incorporated (Nasdaq:VICL) today reported financial results
for the three and twelve months ended December 31, 2016. Net loss
for the fourth quarter of 2016 was $2.8 million, or $0.25 per
share, compared with a net loss of $2.4 million, or $0.26 per
share, for the fourth quarter of 2015. Revenues for the fourth
quarter of 2016 were $3.2 million, which was primarily comprised of
revenues from Astellas Pharma Inc. for services performed under the
ASP0113 collaboration agreements, compared with revenues of $6.8
million for the fourth quarter of 2015. Revenue for 2015 included
$4.1 million of non-recurring revenue from IPPOX for the
manufacture of an HIV vaccine.
Vical had cash and investments of $41.0 million
at December 31, 2016. The Company’s net cash use for 2016 was $8.8
million, which was consistent with the Company’s full year cash
burn guidance of between $8 million and $11 million. The Company is
projecting net cash burn for 2017 between $8 million and $11
million.
Operational updates include:
CMV Vaccine – ASP0113
- Recruitment in the multinational Phase 3 registration trial in
hematopoietic cell transplant (HCT) recipients met its target
enrollment of 500 subjects in September 2016. The primary endpoint
of the trial is a composite of overall mortality and CMV end organ
disease which will be assessed one year after transplantation.
Astellas expects top-line data to be available in the first quarter
of 2018. Vical and Astellas continue to make progress towards a
potential BLA filing in 2018. As a reminder, ASP0113 is the first
CMV vaccine to enter a pivotal Phase 3 trial.
HSV-2 Vaccine
– VCL-HB01
- Recruitment in our Phase 2 trial of the VCL-HB01 HSV-2
therapeutic vaccine is proceeding according to plan. VCL-HB01 is a
Vaxfectin®-formulated bivalent vaccine encoding full-length HSV-2
antigens gD and UL46. The 2:1 randomized, double-blind,
placebo-controlled trial is being conducted at approximately 15
U.S. clinical sites and will evaluate the efficacy and safety of
the vaccine in approximately 225 otherwise healthy adults aged 18
to 50 years with symptomatic genital HSV-2 infection. The primary
endpoint of the study is annualized lesion recurrence rate which is
a clinically meaningful endpoint for both patients and treating
physicians as it provides important information on both the number
and spacing of recurrences over time in this chronic disease
setting. We expect the top-line data to be available in the second
quarter of 2018.
VL-2397 – Drug for Invasive Fungal
Infections
- Vical has completed its first-in-human Phase 1 trial of its
novel antifungal, VL-2397. The randomized, double-blind,
placebo-controlled trial was designed to evaluate safety,
tolerability and pharmacokinetics of single and multiple ascending
doses of intravenous VL-2397 in approximately 90 healthy
volunteers. Preliminary results point to a favorable safety and
pharmacokinetic profile for VL-2397. We expect to present the full
data set at an upcoming scientific conference in 2017. In
preclinical studies, VL-2397 has demonstrated rapid and potent
antifungal activity against a range of invasive fungal pathogens,
including frequently-occurring Aspergillus species, azole-resistant
Aspergillus fumigatus, Candida glabrata and Cryptococcus
neoformans. Our plan is to initiate a Phase 2 efficacy study to
evaluate VL-2397 in the treatment of patients with invasive
aspergillosis and we are working with our clinical experts and the
FDA towards this objective. Invasive aspergillosis represents a
sizeable unmet need given the high mortality rate in
immunocompromised patients, despite available antifungal
therapies.
Vical will conduct a conference call and webcast
today, March 9, 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 (913)
312-0639 (preferred), or (888)778-8903 (toll-free), and reference
confirmation code 9560352. 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 9560352. The call will also
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 develops biopharmaceutical products for
the prevention and treatment of chronic or life-threatening
infectious diseases, based on its patented DNA delivery
technologies and other therapeutic approaches. 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 plans, timing of initiation, enrollment and
announcement of data for clinical trials, plans and timing of
regulatory filings and potential markets for Vical’s product
candidates. Risks and uncertainties include whether Vical or others
will continue development of ASP0113, VCL-HB01 vaccine candidate,
VL-2397 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 Vical or its collaboration
partners will be able to obtain regulatory allowances or guidance
necessary to proceed with proposed clinical trials or implement
anticipated clinical trial designs; whether on-going or planned
clinical trials will be initiated or completed on the timelines
Vical currently expects; whether any product candidates will be
shown to be safe and efficacious in clinical trials; whether Vical
is able to continue its collaborative arrangements or enter into
new ones; whether Vical will have access to sufficient capital to
fund its planned development activities; 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.
VICAL
INCORPORATED |
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Selected Condensed Financial Information
(Unaudited) |
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Three Months Ended |
|
Twelve Months Ended |
|
Statements of Operations |
December 31, |
|
December 31, |
|
(in
thousands, except per share amounts) |
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue |
$ |
2,776 |
|
|
$ |
6,478 |
|
|
$ |
12,804 |
|
|
$ |
18,860 |
|
|
License
and royalty revenue |
|
387 |
|
|
|
335 |
|
|
|
1,727 |
|
|
|
2,090 |
|
|
Total
revenues |
|
3,163 |
|
|
|
6,813 |
|
|
|
14,531 |
|
|
|
20,950 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
2,975 |
|
|
|
2,839 |
|
|
|
10,355 |
|
|
|
11,061 |
|
|
Manufacturing and production |
|
1,231 |
|
|
|
4,301 |
|
|
|
6,291 |
|
|
|
10,927 |
|
|
General
and administrative |
|
1,732 |
|
|
|
2,095 |
|
|
|
7,062 |
|
|
|
8,366 |
|
|
Total
operating expenses |
|
5,938 |
|
|
|
9,235 |
|
|
|
23,708 |
|
|
|
30,354 |
|
|
Loss from
operations |
|
(2,775 |
) |
|
|
(2,422 |
) |
|
|
(9,177 |
) |
|
|
(9,404 |
) |
|
Net
investment and other income |
|
3 |
|
|
|
67 |
|
|
|
204 |
|
|
|
166 |
|
|
Net
loss |
$ |
(2,772 |
) |
|
$ |
(2,355 |
) |
|
$ |
(8,973 |
) |
|
$ |
(9,238 |
) |
|
Basic
and diluted net loss per share |
$ |
(0.25 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.90 |
) |
|
$ |
(1.01 |
) |
|
Weighted
average shares used in computing basic and diluted net loss per
share |
11,103 |
|
|
9,206 |
|
|
10,019 |
|
|
9,175 |
|
|
|
|
|
|
|
|
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|
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|
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|
|
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Balance Sheets |
|
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|
December 31, |
|
December 31, |
|
(in
thousands) |
|
|
|
|
|
|
2016 |
|
|
2015 |
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash,
cash equivalents, and marketable securities, including
restricted |
|
|
|
|
|
|
$ |
38,932 |
|
|
$ |
39,954 |
|
|
Other
current assets |
|
|
|
|
|
|
|
8,935 |
|
|
|
4,544 |
|
|
Total
current assets |
|
|
|
|
|
|
|
47,867 |
|
|
|
44,498 |
|
|
Long-term investments |
|
|
|
|
|
|
|
2,046 |
|
|
|
2,052 |
|
|
Property
and equipment, net |
|
|
|
|
|
|
|
1,173 |
|
|
|
1,873 |
|
|
Other
assets |
|
|
|
|
|
|
|
1,198 |
|
|
|
1,491 |
|
|
Total
assets |
|
|
|
|
|
|
$ |
52,284 |
|
|
$ |
49,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
$ |
7,145 |
|
|
$ |
4,162 |
|
|
Long-term
liabilities |
|
|
|
|
|
|
|
- |
|
|
|
359 |
|
|
Stockholders' equity |
|
|
|
|
|
|
|
45,139 |
|
|
|
45,393 |
|
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
52,284 |
|
|
$ |
49,914 |
|
|
|
|
|
|
|
|
|
|
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Contacts:
Andrew Hopkins
(858) 646-1127
Website: www.vical.com
Anthony Ramos
Vice President and Chief Accounting Officer
Vical (NASDAQ:VICL)
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