Vical Reports Second Quarter 2017 Financial and Operational Results
August 08 2017 - 6:30AM
Vical Incorporated (Nasdaq:VICL) today reported financial results
for the three months ended June 30, 2017. Net loss for the second
quarter of 2017 was $3.3 million, or $0.30 per share, compared with
a net loss of $1.3 million, or $0.14 per share, for the second
quarter of 2016. Revenues for the second quarter of 2017 were $3.4
million, compared with revenues of $4.1 million for the second
quarter of 2016, reflecting revenues from Astellas Pharma Inc. for
manufacturing services performed under ASP0113 collaborative
agreements.
Vical had cash and investments of $37.3 million
at June 30, 2017. The Company’s net cash burn for the first six
months of 2017 was $3.6 million, which was consistent with the
Company’s full year guidance of between $8 million and $11
million.
Program updates include:
ASP0113 CMV Therapeutic
Vaccine
- The multinational Phase 3 registration trial in HCT recipients
completed enrollment in September 2016 with a total of 515 subjects
and is nearing completion of the one year follow-up period. 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. Assuming a
successful trial outcome, Astellas intends to commercialize ASP0113
in North America, Europe, and Asia.
VCL-HB01 HSV-2 Therapeutic
Vaccine
- Vical is developing a HSV-2 therapeutic vaccine to reduce
lesion recurrences in patients with symptomatic genital herpes
infection. Its VCL-HB01 vaccine encodes two full-length HSV-2
antigens gD and UL46, and is formulated with Vical’s proprietary
adjuvant, Vaxfectin®. The vaccine is being evaluated in a Phase 2
study in healthy adult subjects, 18 to 50 years of age who are
randomized 2:1 to receive either vaccine or placebo. Recruitment of
261 subjects at 15 U.S. clinical sites was completed in April 2017
and 4-dose vaccination series was completed in July 2017. All
active subjects are currently being monitored for lesion
recurrences during a 12-month follow-up period. The primary
endpoint of the study is annualized recurrence rate which is a
clinically meaningful endpoint for both patients and treating
physicians as it provides important information on the number of
recurrences over time in this chronic disease setting. Vical
remains on target to deliver top-line results during the second
quarter of 2018.
VL-2397 Antifungal
- Vical is developing its novel antifungal, VL-2397, for the
treatment of patients with invasive fungal infections. Vical
plans to conduct a Phase 2 efficacy study to evaluate VL-2397 for
the treatment of invasive aspergillosis. This life-threatening
infection typically affects the lungs of immunocompromised patients
and represents a major unmet medical need given the high mortality
rate despite availability of current antifungal therapies.
The FDA has granted Vical Qualified Infectious Disease Product
(QIDP), Orphan Drug and Fast Track designations to VL-2397 for the
treatment of invasive aspergillosis. Under the QIDP designation
Vical has interacted intensively with the FDA on the design of the
Phase 2 trial and in exploring an expedited development pathway for
VL‑2397. The Company intends to initiate the trial in the fourth
quarter of 2017.
Vical will conduct a conference call and webcast
today, August 8, 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)325-4771 (preferred), or (888)417-2254 (toll-free), and
reference confirmation code 6860083. 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 6860083. The
webcast 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. 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
Statements of Operations |
June 30, |
|
June 30, |
|
(in
thousands, except per share amounts) |
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract revenue |
$ |
3,369 |
|
|
$ |
3,630 |
|
|
$ |
6,270 |
|
|
$ |
7,718 |
|
|
License and royalty revenue |
|
52 |
|
|
|
492 |
|
|
|
356 |
|
|
|
1,008 |
|
|
Total
revenues |
|
3,421 |
|
|
|
4,122 |
|
|
|
6,626 |
|
|
|
8,726 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
3,639 |
|
|
|
2,303 |
|
|
|
6,939 |
|
|
|
4,781 |
|
|
Manufacturing and production |
|
1,602 |
|
|
|
1,221 |
|
|
|
2,911 |
|
|
|
4,067 |
|
|
General and administrative |
|
1,591 |
|
|
|
1,919 |
|
|
|
3,100 |
|
|
|
3,709 |
|
|
Total
operating expenses |
|
6,832 |
|
|
|
5,443 |
|
|
|
12,950 |
|
|
|
12,557 |
|
|
Loss from operations |
|
(3,411 |
) |
|
|
(1,321 |
) |
|
|
(6,324 |
) |
|
|
(3,831 |
) |
|
Net investment and other income |
|
91 |
|
|
|
66 |
|
|
|
180 |
|
|
|
153 |
|
|
Net
loss |
$ |
(3,320 |
) |
|
$ |
(1,255 |
) |
|
$ |
(6,144 |
) |
|
$ |
(3,678 |
) |
|
Basic
and diluted net loss per share |
$ |
(0.30 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.40 |
) |
|
Weighted
average shares used in computing |
|
|
|
|
|
|
|
|
|
|
|
|
basic and diluted net loss per share |
11,139 |
|
|
9,240 |
|
|
11,121 |
|
|
9,232 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets |
|
|
|
|
|
|
June 30, |
|
December 31, |
|
(in
thousands) |
|
|
|
|
|
|
2017 |
|
|
2016 |
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and marketable |
|
|
|
|
|
|
|
|
|
|
|
|
securities, including restricted |
|
|
|
|
|
|
$ |
35,174 |
|
|
$ |
38,932 |
|
|
Other current assets |
|
|
|
|
|
|
|
11,345 |
|
|
|
8,935 |
|
|
Total
current assets |
|
|
|
|
|
|
|
46,519 |
|
|
|
47,867 |
|
|
Long-term investments |
|
|
|
|
|
|
|
2,159 |
|
|
|
2,046 |
|
|
Property
and equipment, net |
|
|
|
|
|
|
|
749 |
|
|
|
1,173 |
|
|
Other
assets |
|
|
|
|
|
|
|
1,356 |
|
|
|
1,198 |
|
|
Total
assets |
|
|
|
|
|
|
$ |
50,783 |
|
|
$ |
52,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
$ |
10,983 |
|
|
$ |
7,145 |
|
|
Stockholders' equity |
|
|
|
|
|
|
|
39,800 |
|
|
|
45,139 |
|
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
50,783 |
|
|
$ |
52,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts:
Andrew Hopkins
(858) 646-1127
Website: www.vical.com
Anthony Ramos
Vice President and Chief Financial Officer
Vical (NASDAQ:VICL)
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