Vical Reports First Quarter 2015 Financial Results and Progress in Key Development Programs
May 08 2015 - 6:30AM
Vical Incorporated (Nasdaq:VICL) today reported financial results
for the three months ended March 31, 2015. Net loss for the first
quarter of 2015 was $3.8 million, or $0.04 per share, compared with
a net loss of $3.5 million, or $0.04 per share, for the first
quarter of 2014. Revenues for the first quarter of 2015 were $4.9
million, compared with revenues of $2.4 million for the first
quarter of 2014, reflecting higher 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 had cash and investments of $46.3 million at March 31,
2015. The Company's net cash burn for the first quarter of 2015 was
$2.9 million, which reflects the advancement of the Company's
clinical programs and its ongoing efforts to manage its operating
expenses. The net cash burn for the first quarter was consistent
with the Company's prior guidance of $12 to $15 million cash burn
for the full year.
Program highlights include:
HSV-2 Vaccine
- Vical's Phase 1/2 trial of its therapeutic herpes simplex virus
(HSV-2) vaccine, designed to reduce genital viral shedding and
lesions in HSV-2 infected subjects, is progressing according to
plan. The randomized, double-blind, placebo-controlled trial
enrolled a total of 165 subjects ages 18 to 50 years at seven U.S.
clinical sites and will evaluate safety, tolerability and efficacy.
The Company expects to release topline data, including genital
viral shedding rates and lesion rates, by the middle of this
year.
ASP0113 CMV Vaccine
- Astellas continues to enroll patients in Vical's partnered
ASP0113 clinical programs. ASP0113 is a therapeutic vaccine
designed to prevent CMV reactivation and infection in hematopoietic
stem cell transplant (HCT) recipients and solid organ transplant
recipients.
- Enrollment in the multinational Phase 3 registrational trial in
approximately 500 HCT recipients is proceeding according to plan,
with Astellas projecting enrollment to be completed by the end of
this year.
- Enrollment in the multinational Phase 2 trial in approximately
140 kidney transplant recipients is nearing completion. Astellas
expects enrollment in the trial to be completed by the end of the
second quarter of this year.
ASP2397 Antifungal Compound
- In March 2015, Vical expanded its infectious disease portfolio
with the addition of a novel antifungal, ASP2397, in-licensed from
Astellas. ASP2397 is part of a potential new class of antifungal
compounds to address invasive fungal infections, such as invasive
aspergillosis, which are major causes of morbidity and mortality in
immunocompromised patients, including transplant recipients.
ASP2397 is differentiated by a new mechanism of action and has
shown a low propensity for P450 drug-drug interactions. In
preclinical studies to date, it has demonstrated faster fungicidal
activity than marketed drugs and activity against azole-resistant
fungal pathogens. Vical is targeting initiation of a Phase 1 trial
in the first half of 2016.
HIV Vaccine Collaboration with
Public-Private Partnership
- In April 2015, Vical entered into a $4 million contract with
the IPPOX Foundation, funded via a grant from the Bill &
Melinda Gates Foundation, to supply vaccine for HIV vaccine
clinical trials. Vical also signed a Memorandum of Understanding
with the Gates Foundation to cooperate on HIV vaccine
projects.
Vical will conduct a conference call and webcast today, May 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) 325-2244 (preferred), or (888)
505-4369 (toll-free), and reference confirmation code 9556967. 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 9556967. The call also will 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
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, ASP2397, 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 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 |
Statements of
Operations |
March 31, |
(in thousands, except per share amounts) |
2015 |
2014 |
Revenues: |
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Contract and grant revenue |
$ 4,274 |
$ 2,118 |
License and royalty revenue |
670 |
329 |
Total revenues |
4,944 |
2,447 |
Operating expenses: |
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Research and development |
3,637 |
2,146 |
Manufacturing and production |
2,941 |
1,515 |
General and administrative |
2,223 |
2,269 |
Total operating expenses |
8,801 |
5,930 |
Loss from operations |
(3,857) |
(3,483) |
Net investment and other income |
36 |
28 |
Net loss |
$ (3,821) |
$ (3,455) |
Basic and diluted net loss per share |
$ (0.04) |
$ (0.04) |
Weighted average shares used in computing
basic and diluted net loss per share |
90,870 |
87,110 |
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Balance Sheets |
March 31, |
December 31, |
(in thousands) |
2015 |
2014 |
Assets: |
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Cash, cash equivalents, and marketable
securities, including restricted |
$ 44,233 |
$ 47,152 |
Other current assets |
3,709 |
4,178 |
Total current assets |
47,942 |
51,330 |
Long-term investments |
2,034 |
1,971 |
Property and equipment, net |
2,427 |
2,639 |
Other assets |
1,975 |
2,039 |
Total assets |
$ 54,378 |
$ 57,979 |
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Liabilities and stockholders' equity: |
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Current liabilities |
$ 4,129 |
$ 5,201 |
Long-term liabilities |
737 |
856 |
Stockholders' equity |
49,512 |
51,922 |
Total liabilities and stockholders'
equity |
$ 54,378 |
$ 57,979 |
CONTACT: Andrew Hopkins
(858) 646-1127
Website: www.vical.com
Anthony Ramos
Vice President and Chief Accounting Officer
Vical (NASDAQ:VICL)
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