Vical Reports Fourth Quarter 2015 Financial Results
March 14 2016 - 6:30AM
Futility Analyses Completed on CMV Phase
3 Trial in HCT Patients and Trial Continuing as
Planned
Vical Incorporated (Nasdaq:VICL) today reported financial results
for the three and twelve months ended December 31, 2015. Net loss
for the fourth quarter of 2015 was $2.4 million, or $0.03 per
share, compared with a net loss of $4.6 million, or $0.05 per
share, for the fourth quarter of 2014. Revenues for the fourth
quarter of 2015 were $6.8 million, compared with revenues of $4.8
million for the fourth quarter of 2014, reflecting revenues from
IPPOX for the manufacture of HIV vaccine. This vaccine is
expected to be used as a priming component of prime/boost vaccine
regimens that will be evaluated in clinical trials for the
prevention of HIV infection.
Vical had cash and investments of $42.0 million
at December 31, 2015. The Company’s net cash use for the fourth
quarter of 2015 was $1.9 million, which reflects its ongoing
efforts to manage its operating expenses. The Company's net cash
burn for 2015 was $7.1 million which was consistent with the
Company’s prior guidance. The Company is projecting net cash burn
for 2016 between $8 million and $11 million.
Program updates include:
ASP0113 CMV Vaccine
- Enrollment in the multinational Phase 3 registration trial in
500 hematopoietic cell transplant (HCT) recipients is ongoing.
Astellas has finalized the primary endpoint as a composite of
overall mortality and CMV end organ disease. During the course of
the trial, an independent statistician conducted a series of
futility analyses based upon viral load. The final of these
analyses has now been completed and the trial is continuing as
planned. Both Astellas and Vical remain blinded to the results of
the analyses. 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
- Vical recently obtained the 9-month efficacy data from its
HSV-2 Phase 1/2 study and the bivalent vaccine continued to achieve
statistically significant reductions in the clinically meaningful
secondary endpoint of genital lesion rate when compared to the
pre-vaccination period, an effect that was durable to nine months.
Neither the placebo nor the monovalent vaccine groups achieved
statistical significance on this endpoint at nine months after
vaccination. Vical is reviewing this encouraging data and T-cell
immunogenicity results with its clinical advisory board to
determine the best path forward for the program. The company
intends to present the detailed 9-month data at an upcoming
scientific conference.
VL-2397 Antifungal
- Vical recently announced that enrollment has been initiated in
a first-in-human Phase 1 trial of its novel antifungal, VL-2397,
for invasive pulmonary aspergillosis. The randomized, double-blind,
placebo-controlled trial will evaluate safety, tolerability and
pharmacokinetics of VL-2397 at single and multiple ascending doses
in otherwise healthy volunteers at one U.S. clinical site. The U.S.
Food and Drug Administration (FDA) recently granted Vical orphan
drug and qualified infectious disease product (QIDP)
designation for VL-2397 for the treatment of invasive
aspergillosis. The company also presented preclinical data on
VL-2397 at the Interscience Conference of Antimicrobial Agents and
Chemotherapy (ICAAC) in September 2015.
Vical will conduct a conference call and webcast
today, March 14, 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)
325-2494 (preferred), or (888) 576-4398 (toll-free), and reference
confirmation code 2761479. 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 2761479. 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 on-going or planned clinical trials will be
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; 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.
VICAL INCORPORATED |
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) |
2015 |
|
2014 |
|
2015 |
|
2014 |
Revenues: |
|
|
|
|
|
|
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|
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|
|
Contract revenue |
$ |
|
6,478 |
|
|
$ |
|
4,231 |
|
|
$ |
|
18,860 |
|
|
$ |
|
13,304 |
|
License and royalty revenue |
|
|
335 |
|
|
|
|
592 |
|
|
|
|
2,090 |
|
|
|
|
1,913 |
|
Total revenues |
|
|
6,813 |
|
|
|
|
4,823 |
|
|
|
|
20,950 |
|
|
|
|
15,217 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,839 |
|
|
|
|
3,762 |
|
|
|
|
11,061 |
|
|
|
|
11,467 |
|
Manufacturing and production |
|
|
4,301 |
|
|
|
|
3,367 |
|
|
|
|
10,927 |
|
|
|
|
10,824 |
|
General and administrative |
|
|
2,095 |
|
|
|
|
2,376 |
|
|
|
|
8,366 |
|
|
|
|
9,552 |
|
Total operating
expenses |
|
|
9,235 |
|
|
|
|
9,505 |
|
|
|
|
30,354 |
|
|
|
|
31,843 |
|
Loss from operations |
|
|
(2,422 |
) |
|
|
|
(4,682 |
) |
|
|
|
(9,404 |
) |
|
|
|
(16,626 |
) |
Net investment and other
income |
|
|
67 |
|
|
|
|
49 |
|
|
|
|
166 |
|
|
|
|
134 |
|
Net loss |
$ |
|
(2,355 |
) |
|
$ |
|
(4,633 |
) |
|
$ |
|
(9,238 |
) |
|
$ |
|
(16,492 |
) |
Basic and diluted net
loss per share |
$ |
|
(0.03 |
) |
|
$ |
|
(0.05 |
) |
|
$ |
|
(0.10 |
) |
|
$ |
|
(0.19 |
) |
Weighted average shares
used in computing |
|
|
|
|
|
|
|
|
|
|
|
basic and diluted net
loss per share |
92,061 |
|
90,631 |
|
91,751 |
|
88,786 |
|
|
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Balance
Sheets |
|
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|
December 31, |
|
December 31, |
(in thousands) |
|
|
|
|
|
|
2015 |
|
2014 |
Assets: |
|
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|
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Cash, cash equivalents, and
marketable |
|
|
|
|
|
|
|
|
|
|
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securities, including
restricted |
|
|
|
|
|
|
$ |
|
39,954 |
|
|
$ |
|
47,152 |
|
Other current assets |
|
|
|
|
|
|
|
|
4,544 |
|
|
|
|
4,178 |
|
Total current
assets |
|
|
|
|
|
|
|
|
44,498 |
|
|
|
|
51,330 |
|
Long-term
investments |
|
|
|
|
|
|
|
|
2,052 |
|
|
|
|
1,971 |
|
Property and equipment,
net |
|
|
|
|
|
|
|
|
1,873 |
|
|
|
|
2,639 |
|
Other assets |
|
|
|
|
|
|
|
|
1,491 |
|
|
|
|
2,039 |
|
Total assets |
|
|
|
|
|
|
$ |
|
49,914 |
|
|
$ |
|
57,979 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
$ |
|
4,162 |
|
|
$ |
|
5,201 |
|
Long-term liabilities |
|
|
|
|
|
|
|
|
359 |
|
|
|
|
856 |
|
Stockholders' equity |
|
|
|
|
|
|
|
|
45,393 |
|
|
|
|
51,922 |
|
Total liabilities and
stockholders' equity |
|
|
|
|
|
|
$ |
|
49,914 |
|
|
$ |
|
57,979 |
|
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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