Vical Reports Third Quarter 2015 Financial Results and Progress in Key Development Programs
October 29 2015 - 6:30AM
Vical Incorporated (Nasdaq:VICL) today reported financial results
for the three and nine months ended September 30, 2015. Net loss
for the third quarter of 2015 was $0.3 million, or $0.00 per share,
compared with a net loss of $4.4 million, or $0.05 per share, for
the third quarter of 2014. Revenues for the third quarter of 2015
were $5.0 million, compared with revenues of $3.4 million for the
third quarter of 2014, reflecting increased revenues from Astellas
Pharma Inc. for manufacturing services performed under our ASP0113
collaborative agreements. ASP0113 is Vical's therapeutic vaccine
designed to prevent cytomegalovirus (CMV) disease and associated
complications in transplant recipients.
Vical generated positive cash flow for the third quarter of 2015
of $0.2 million. The Company had cash and investments of $43.9
million at September 30, 2015 compared to $49.1 million at December
31, 2014. The Company is updating its 2015 full year cash burn
guidance to a range of between $7 million and $9 million, a
reduction in cash burn from its previous forecast of between $9
million and $12 million.
Program updates include:
ASP0113 CMV Vaccine
- Enrollment in the multinational Phase 3 registrational trial in
approximately 500 hematopoietic cell transplant recipients is
ongoing. Astellas has finalized the primary endpoint as a composite
of overall mortality and CMV end organ disease and has decided to
forego the adaptive trial design. Astellas is in active discussions
with regulatory agencies to obtain their concurrence on the
selected endpoint. Astellas expects enrollment in the trial to be
completed by the third quarter of 2016, with the top-line data
being available in the fourth quarter of 2017.
- Enrollment in the multinational Phase 2 trial in kidney
transplant recipients is complete. 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 one year
after transplantation. Top-line trial data are expected to be
available in the third quarter of 2016.
HSV-2 Vaccine
- The subjects in the ongoing Phase 1/2 HSV-2 study will continue
to be followed for a period of twelve months for safety and nine
months for efficacy following their last dose. Vical expects that
additional efficacy data will be available for analysis in December
and will enable Vical to determine the next steps for the HSV-2
program by early next year.
VL-2397 Antifungal
- In August 2015, Vical's novel antifungal, VL-2397, received a
qualified infectious disease product, or QIDP, designation from the
FDA for the treatment of invasive aspergillosis. Vical is targeting
initiation of a Phase 1 trial in the first half of 2016. This will
be a randomized, double-blind study to determine the safety,
tolerability, and pharmacokinetics of single and multiple ascending
doses of VL-2397 administered by infusion in healthy
volunteers.
Vical will conduct a conference call and webcast today, October
29, 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) 325-2376 (preferred), or (888)
401-4669 (toll-free), and reference confirmation code 3993142. 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 3993142. 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 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 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; 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) |
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Three Months Ended |
Nine Months Ended |
Statements of
Operations |
September 30, |
September 30, |
(in thousands, except per share amounts) |
2015 |
2014 |
2015 |
2014 |
Revenues: |
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Contract revenue |
$ 4,427 |
$ 3,004 |
$ 12,382 |
$ 9,073 |
License and royalty
revenue |
590 |
438 |
1,755 |
1,321 |
Total revenues |
5,017 |
3,442 |
14,137 |
10,394 |
Operating expenses: |
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Research and development |
2,128 |
3,180 |
8,222 |
7,705 |
Manufacturing and
production |
1,306 |
2,292 |
6,626 |
7,457 |
General and administrative |
1,916 |
2,366 |
6,271 |
7,176 |
Total operating expenses |
5,350 |
7,838 |
21,119 |
22,338 |
Loss from operations |
(333) |
(4,396) |
(6,982) |
(11,944) |
Net investment and other
income |
33 |
32 |
99 |
85 |
Net loss |
$ (300) |
$ (4,364) |
$ (6,883) |
$ (11,859) |
Basic and diluted net loss per share |
$ (0.00) |
$ (0.05) |
$ (0.08) |
$ (0.13) |
Weighted average shares used in computing
basic and diluted net loss per share |
91,957 |
89,976 |
91,600 |
88,154 |
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Balance Sheets |
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September 30, |
December 31, |
(in thousands) |
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2015 |
2014 |
Assets: |
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Cash, cash equivalents, and
marketable securities, including restricted |
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$ 41,851 |
$ 47,152 |
Other current assets |
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5,769 |
4,178 |
Total current assets |
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47,620 |
51,330 |
Long-term investments |
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2,077 |
1,971 |
Property and equipment, net |
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2,010 |
2,639 |
Other assets |
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1,713 |
2,039 |
Total assets |
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$ 53,420 |
$ 57,979 |
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Liabilities and stockholders' equity: |
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Current liabilities |
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$ 5,474 |
$ 5,201 |
Long-term liabilities |
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494 |
856 |
Stockholders' equity |
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47,452 |
51,922 |
Total liabilities and stockholders'
equity |
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$ 53,420 |
$ 57,979 |
CONTACT: Andrew Hopkins
Anthony Ramos
Vice President and Chief Accounting Officer
(858) 646-1127
Website: www.vical.com
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