Vical Reports Third Quarter 2016 Financial Results
November 03 2016 - 6:30AM
Vical Incorporated (Nasdaq:VICL) today reported financial results
for the three and nine months ended September 30, 2016. Net loss
for the third quarter of 2016 was $2.5 million, or $0.24 per share,
compared with a net loss of $0.3 million, or $0.03 per share, for
the third quarter of 2015. Revenues for the third quarter of 2016
were $2.6 million, compared with revenues of $5.0 million for the
third quarter of 2015, reflecting revenues from Astellas Pharma
Inc. for manufacturing services performed under the ASP0113
collaborative agreements. ASP0113 is Vical’s therapeutic vaccine
designed to prevent cytomegalovirus (CMV) disease and associated
complications in transplant recipients.
Vical had cash and investments of $43.0 million
at September 30, 2016. The Company’s net cash use for the first
nine months of 2016 was $6.8 million, which was consistent with the
Company’s guidance for the full year. The Company is projecting net
cash burn for 2016 between $8 million and $11 million.
Operational updates include:
ASP0113 CMV Vaccine
- Recruitment in the multinational Phase 3 registration trial in
hematopoietic cell transplant (HCT) recipients met its target
enrollment of 500 subjects in September and is now fully enrolled.
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 now expects top-line data to be
available in the first quarter of 2018. Vical and Astellas continue
to make substantial progress in process validation activities for
the manufacture of the bulk drug product in anticipation of a
potential BLA filing in 2018.
HSV-2 Therapeutic Vaccine
- In September 2016, Vical announced the initiation of a Phase 2
trial of its bivalent HSV-2 therapeutic vaccine. The 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 and was selected following consultation with
clinical experts and the FDA. This endpoint is clinically
meaningful 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.
VL-2397 Antifungal
- Dosing has been completed in Vical’s first-in-human Phase 1
trial of its novel antifungal, VL-2397. The randomized,
double-blind, placebo-controlled trial is designed to evaluate
safety, tolerability and pharmacokinetics of single and multiple
ascending doses of intravenous VL-2397 in healthy volunteers.
Safety follow-ups and pharmacokinetic sampling are expected to be
completed by the end of 2016 with data to follow in 2017. Vical is
working actively with its expert advisors and the FDA to design a
Phase 2 efficacy study to evaluate VL-2397 in the treatment of
patients with invasive aspergillosis. This fungal infection
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, November 3, 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
(785)830-7992 (preferred), or (800)768-6569 (toll-free), and
reference confirmation code 1380572. 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 1380572. 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, Vical’s HSV-2 vaccine,
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 |
|
Selected Condensed Financial Information
(Unaudited) |
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|
|
|
|
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|
|
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|
Three Months Ended |
|
Nine Months Ended |
|
Statements of Operations |
September 30, |
|
September 30, |
|
(in
thousands, except per share amounts) |
2016 |
|
2015 |
|
2016 |
|
2015 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract revenue |
$ |
|
2,310 |
|
|
$ |
|
4,427 |
|
|
$ |
|
10,028 |
|
|
$ |
|
12,382 |
|
|
License and royalty revenue |
|
|
332 |
|
|
|
|
590 |
|
|
|
|
1,340 |
|
|
|
|
1,755 |
|
|
Total
revenues |
|
|
2,642 |
|
|
|
|
5,017 |
|
|
|
|
11,368 |
|
|
|
|
14,137 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,599 |
|
|
|
|
2,128 |
|
|
|
|
7,380 |
|
|
|
|
8,222 |
|
|
Manufacturing and production |
|
|
993 |
|
|
|
|
1,306 |
|
|
|
|
5,060 |
|
|
|
|
6,626 |
|
|
General and administrative |
|
|
1,621 |
|
|
|
|
1,916 |
|
|
|
|
5,330 |
|
|
|
|
6,271 |
|
|
Total
operating expenses |
|
|
5,213 |
|
|
|
|
5,350 |
|
|
|
|
17,770 |
|
|
|
|
21,119 |
|
|
Loss from operations |
|
|
(2,571 |
) |
|
|
|
(333 |
) |
|
|
|
(6,402 |
) |
|
|
|
(6,982 |
) |
|
Net investment and other income |
|
|
48 |
|
|
|
|
33 |
|
|
|
|
201 |
|
|
|
|
99 |
|
|
Net
loss |
$ |
|
(2,523 |
) |
|
$ |
|
(300 |
) |
|
$ |
|
(6,201 |
) |
|
$ |
|
(6,883 |
) |
|
Basic
and diluted net loss per share |
$ |
|
(0.24 |
) |
|
$ |
|
(0.03 |
) |
|
$ |
|
(0.64 |
) |
|
$ |
|
(0.75 |
) |
|
Weighted
average shares used in computing |
|
|
|
|
|
|
|
|
|
|
|
|
basic and diluted net loss per share |
10,453 |
|
9,196 |
|
9,647 |
|
9,160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets |
|
|
|
|
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|
September 30, |
|
December 31, |
|
(in
thousands) |
|
|
|
|
|
|
2016 |
|
2015 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and marketable |
|
|
|
|
|
|
|
|
|
|
|
|
securities, including restricted |
|
|
|
|
|
|
$ |
|
40,761 |
|
|
$ |
|
39,954 |
|
|
Other current assets |
|
|
|
|
|
|
|
|
6,249 |
|
|
|
|
4,544 |
|
|
Total
current assets |
|
|
|
|
|
|
|
|
47,010 |
|
|
|
|
44,498 |
|
|
Long-term investments |
|
|
|
|
|
|
|
|
2,217 |
|
|
|
|
2,052 |
|
|
Property
and equipment, net |
|
|
|
|
|
|
|
|
1,375 |
|
|
|
|
1,873 |
|
|
Other
assets |
|
|
|
|
|
|
|
|
1,226 |
|
|
|
|
1,491 |
|
|
Total
assets |
|
|
|
|
|
|
$ |
|
51,828 |
|
|
$ |
|
49,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
$ |
|
3,965 |
|
|
$ |
|
4,162 |
|
|
Long-term liabilities |
|
|
|
|
|
|
|
|
- |
|
|
|
|
359 |
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
47,863 |
|
|
|
|
45,393 |
|
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
|
51,828 |
|
|
$ |
|
49,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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