Vical Reports Second Quarter 2016 Financial Results
August 09 2016 - 5:30AM
Vical Incorporated (Nasdaq:VICL) today reported financial results
for the three and six months ended June 30, 2016. Net loss for the
second quarter of 2016 was $1.3 million, or $0.14 per share,
compared with a net loss of $2.8 million, or $0.30 per share, for
the second quarter of 2015. Revenues for the second quarter of 2016
were $4.1 million, compared with revenues of $4.2 million for the
second 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 $38.5 million
at June 30, 2016. This cash balance does not include the $7.8
million in proceeds received from the Company’s recently completed
private placement. The Company’s net cash use for the first six
months of 2016 was $3.5 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, which
includes the cash burn associated with the planned initiation of
the HSV-2 Phase 2 clinical program later this year.
Operational updates include:
ASP0113 CMV Vaccine
- Recruitment in the multinational Phase 3 registration trial in
500 hematopoietic cell transplant (HCT) recipients is nearing
completion with over 90% of the subjects enrolled. Astellas expects
enrollment to be completed during the third quarter of 2016, with
the top-line data expected to be available in the fourth quarter of
2017. The primary endpoint of this trial is a composite of overall
mortality and CMV end organ disease. Vical and Astellas have made
substantial progress in process validation activities for the
manufacture of the bulk drug product in anticipation of a potential
BLA filing in 2018.
- One year follow up in the multinational Phase 2 trial in kidney
transplant recipients is now complete. Astellas is completing
the final verification of all outstanding data and expects to
release the top-line trial results during the third quarter of
2016. The primary endpoint of this trial is the incidence of CMV
viremia and the study is powered to show an approximately 50%
reduction in CMV viremia at 1 year after transplantation. The study
also includes a key clinically relevant secondary endpoint,
incidence of CMV disease.
HSV-2 Therapeutic Vaccine
- Vical plans to initiate a Phase 2 trial of its bivalent HSV-2
therapeutic vaccine during the second half of 2016. The randomized,
double-blind, placebo-controlled trial will evaluate the safety and
efficacy of the vaccine in approximately 225 otherwise healthy
adults aged 18 to 50 years with symptomatic genital HSV-2
infection. Vical is confirming with the FDA the Phase 2 trial
design, which is intended to evaluate the vaccine’s efficacy using
clinical relevant endpoints rather than virologic endpoints.
VL-2397 Antifungal
- Enrollment is ongoing in Vical’s first-in-human Phase 1 trial
of its novel antifungal, VL-2397. The randomized, double-blind,
placebo-controlled trial is intended to evaluate safety,
tolerability and pharmacokinetics of single and multiple ascending
doses of VL-2397 in healthy volunteers. The trial is expected to be
completed by the end of 2016. Vical is working closely with its
expert advisors and the FDA to design a Phase 2 efficacy study for
VL-2397 in the treatment of patients with invasive aspergillosis.
This fungal infection is associated with a high rate of mortality
in immunocompromised patients, and represents a sizeable unmet
medical need for new antifungal therapies.
Equity Investment by AnGes
- On August 1, 2016, Vical announced an agreement by AnGes, MG, a
partner and shareholder in Vical since 2006, to purchase
approximately $7.8 million of Vical’s common stock in a private
placement. The shares were sold at a price of $4.24 per share, the
90-day volume weighted average price of Vical’s common stock and a
premium to the close on the prior trading day. With the new
investment, AnGes’ equity position increased to approximately 18.6%
of Vical’s outstanding shares. The transaction further strengthens
Vical’s relationship with AnGes, which has a strategic interest in
DNA vaccines, including one in its own pipeline, and which has
demonstrated an appreciation for Vical’s DNA technology, and
clinical, regulatory, and manufacturing expertise over the
years.
Vical will conduct a conference call and webcast
today, August 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)
312-0850 (preferred), or (888) 661-5127 (toll-free), and reference
confirmation code 4021640. 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 4021640. 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, and potential markets for
Vica’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.
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VICAL
INCORPORATED |
|
Selected Condensed Financial Information
(Unaudited) |
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|
Three Months Ended |
|
Six Months Ended |
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Statements of Operations |
June 30, |
|
June 30, |
|
(in
thousands, except per share amounts) |
2016 |
|
2015 |
|
2016 |
|
2015 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract revenue |
$ |
|
3,630 |
|
|
$ |
|
3,681 |
|
|
$ |
|
7,718 |
|
|
$ |
|
7,955 |
|
|
License and royalty revenue |
|
|
492 |
|
|
|
|
495 |
|
|
|
|
1,008 |
|
|
|
|
1,165 |
|
|
Total
revenues |
|
|
4,122 |
|
|
|
|
4,176 |
|
|
|
|
8,726 |
|
|
|
|
9,120 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,303 |
|
|
|
|
2,457 |
|
|
|
|
4,781 |
|
|
|
|
6,094 |
|
|
Manufacturing and production |
|
|
1,221 |
|
|
|
|
2,379 |
|
|
|
|
4,067 |
|
|
|
|
5,320 |
|
|
General and administrative |
|
|
1,919 |
|
|
|
|
2,132 |
|
|
|
|
3,709 |
|
|
|
|
4,355 |
|
|
Total
operating expenses |
|
|
5,443 |
|
|
|
|
6,968 |
|
|
|
|
12,557 |
|
|
|
|
15,769 |
|
|
Loss from operations |
|
|
(1,321 |
) |
|
|
|
(2,792 |
) |
|
|
|
(3,831 |
) |
|
|
|
(6,649 |
) |
|
Net investment and other income |
|
|
66 |
|
|
|
|
30 |
|
|
|
|
153 |
|
|
|
|
66 |
|
|
Net
loss |
$ |
|
(1,255 |
) |
|
$ |
|
(2,762 |
) |
|
$ |
|
(3,678 |
) |
|
$ |
|
(6,583 |
) |
|
Basic
and diluted net loss per share |
$ |
|
(0.14 |
) |
|
$ |
|
(0.30 |
) |
|
$ |
|
(0.40 |
) |
|
$ |
|
(0.72 |
) |
|
Weighted
average shares used in computing |
|
|
|
|
|
|
|
|
|
|
|
|
basic and diluted net loss per share |
9,240 |
|
9,189 |
|
9,232 |
|
9,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Balance Sheets |
|
|
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|
June 30, |
|
December 31, |
|
(in
thousands) |
|
|
|
|
|
|
2016 |
|
2015 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and marketable |
|
|
|
|
|
|
|
|
|
|
|
|
securities, including restricted |
|
|
|
|
|
|
$ |
|
36,221 |
|
|
$ |
|
39,954 |
|
|
Other current assets |
|
|
|
|
|
|
|
|
4,751 |
|
|
|
|
4,544 |
|
|
Total
current assets |
|
|
|
|
|
|
|
|
40,972 |
|
|
|
|
44,498 |
|
|
Long-term investments |
|
|
|
|
|
|
|
|
2,238 |
|
|
|
|
2,052 |
|
|
Property
and equipment, net |
|
|
|
|
|
|
|
|
1,578 |
|
|
|
|
1,873 |
|
|
Other
assets |
|
|
|
|
|
|
|
|
1,059 |
|
|
|
|
1,491 |
|
|
Total
assets |
|
|
|
|
|
|
$ |
|
45,847 |
|
|
$ |
|
49,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
$ |
|
3,313 |
|
|
$ |
|
4,162 |
|
|
Long-term liabilities |
|
|
|
|
|
|
|
|
90 |
|
|
|
|
359 |
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
42,444 |
|
|
|
|
45,393 |
|
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
|
45,847 |
|
|
$ |
|
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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