Vical Reports Fourth Quarter 2017 Financial and Operational Results
March 15 2018 - 6:30AM
Vical Incorporated (Nasdaq:VICL) today reported financial results
for the three months ended December 31, 2017. Net loss for the
fourth quarter of 2017 was $3.7 million, or $0.21 per share,
compared with a net loss of $2.8 million, or $0.25 per share, for
the fourth quarter of 2016. Revenues for the fourth quarter of 2017
were $4.0 million, compared with revenues of $3.2 million for the
fourth quarter of 2016, reflecting revenues from Astellas Pharma
Inc. for services performed under ASP0113 collaborative agreements.
Vical had cash and investments of $62.9 million
at December 31, 2017. The Company’s cash burn for 2017 was $8.6
million, which was consistent with the Company’s full year 2017
guidance of between $8 million and $11 million. The Company is
projecting net cash burn for 2018 between $20 million and $24
million.
Program updates include:
VCL-HB01 HSV-2 Therapeutic Vaccine
- Vical is developing an HSV-2 therapeutic vaccine, VCL-HB01, to
treat subjects with symptomatic genital herpes infection. The
vaccine is currently being evaluated in a Phase 2 study in HSV-2
seropositive 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 dosing was completed in July 2017. Following the 4th
vaccination or placebo injection, each subject entered a 12-month
surveillance period during which each new lesion recurrence is
assessed in the clinic by the investigator. Once the last subject
has completed a minimum of 9-months of surveillance, the primary
endpoint of annualized recurrence rate will be calculated based on
those recurrences that are both clinically- and
virologically-confirmed. This endpoint provides important
information on the number of recurrences over time in this chronic
disease setting and is clinically meaningful for both patients and
treating physicians. Vical expects to announce top-line results
during the second quarter of 2018.
VL-2397 Antifungal Drug
- In February, the Company initiated a Phase 2 trial of VL-2397
for the treatment of invasive aspergillosis. The FDA has advised
that VL‑2397 would be eligible for a Limited Use Indication (LUI)
approval for the treatment of invasive aspergillosis, assuming a
successful outcome of a single Phase 2 trial carried out in
accordance with a protocol and statistical analysis plan consistent
with the Agency's advice. The final determination whether the drug
is approvable will be made by FDA after review of all relevant
data. Vical is collaborating with Mycoses Study Group Education and
Research Consortium to advance VL-2397 for the treatment of
invasive aspergillosis. The FDA has granted Vical Qualified
Infectious Disease Product, Orphan Drug and Fast Track designations
for VL-2397 for the treatment of invasive aspergillosis.
Hepatitis B Virus Therapeutic
Drug
- The Company is pursuing early stage development of a novel
treatment for chronic hepatitis B virus (CHB) infection based on
its DNA and lipid-delivery technologies. The initial aim of this
program will be to demonstrate preclinical proof of concept for
inhibiting HBV infection in a mouse model. The ultimate aim will be
to demonstrate eradication of persistent HBV infection in CHB
patients. This preclinical development effort is being conducted in
collaboration with Vical’s strategic partner, AnGes, Inc. of Osaka,
Japan.
ASP0113 CMV Therapeutic
Vaccine
- Astellas and Vical announced in January that ASP0113, a vaccine
being developed for cytomegalovirus-seropositive hematopoietic stem
cell transplant recipients, did not meet its primary or key
secondary endpoints in the Phase 3 HELIOS clinical trial.
Vical will conduct a conference call and webcast
today, March 15, at noon Eastern Time, to discuss the Company’s
financial results and program updates. 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 (323)994-2083 (preferred), or (800)562-8369
(toll-free), and reference confirmation code 2848082. 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
2848082. 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, including antiviral and antifungal candidates
in clinical development. 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,
anticipated developments in independent and collaborative programs,
including the plans, timing of initiation, enrollment and
announcement of data for clinical trials, as well as timing for
potential regulatory submissions, and potential benefits of Vical’s
product candidates. Risks and uncertainties include whether Vical
or others will continue development of VCL-HB01, VL-2397 or any
other independent or collaborative programs; the risk that the FDA
does not grant LUI approval of VL-2397 following the results of
Vical’s planned Phase 2 clinical trial; 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 approvals, allowances or guidance
necessary to commercialize any product or to proceed with proposed
clinical trials or implement anticipated clinical trial designs;
whether on-going or planned clinical trials or regulatory
submissions 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.
Contacts: Andrew
Hopkins(858) 646-1127
Anthony RamosVice President and Chief Financial Officer
Website: www.vical.com
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) |
2017 |
|
2016 |
|
|
2017 |
|
2016 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue |
$ |
3,943 |
|
|
$ |
2,776 |
|
|
$ |
13,401 |
|
|
$ |
12,804 |
|
|
License
and royalty revenue |
|
10 |
|
|
|
387 |
|
|
|
418 |
|
|
|
1,727 |
|
|
Total
revenues |
|
3,953 |
|
|
|
3,163 |
|
|
|
13,819 |
|
|
|
14,531 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
4,448 |
|
|
|
2,975 |
|
|
|
14,391 |
|
|
|
10,355 |
|
|
Manufacturing and production |
|
1,790 |
|
|
|
1,231 |
|
|
|
6,479 |
|
|
|
6,291 |
|
|
General
and administrative |
|
1,596 |
|
|
|
1,732 |
|
|
|
6,335 |
|
|
|
7,062 |
|
|
Total
operating expenses |
|
7,834 |
|
|
|
5,938 |
|
|
|
27,205 |
|
|
|
23,708 |
|
|
Loss from
operations |
|
(3,881 |
) |
|
|
(2,775 |
) |
|
|
(13,386 |
) |
|
|
(9,177 |
) |
|
Net
investment and other income |
|
153 |
|
|
|
3 |
|
|
|
426 |
|
|
|
204 |
|
|
Net
loss |
$ |
(3,728 |
) |
|
$ |
(2,772 |
) |
|
$ |
(12,960 |
) |
|
$ |
(8,973 |
) |
|
Basic
and diluted net loss per share |
$ |
(0.21 |
) |
|
$ |
(0.25 |
) |
|
$ |
(1.01 |
) |
|
$ |
(0.90 |
) |
|
Weighted
average shares used in computing basic and diluted net loss
per share |
|
17,778 |
|
|
|
11,103 |
|
|
|
12,888 |
|
|
|
10,019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets |
|
|
|
|
|
|
December 31, |
|
December 31, |
|
(in
thousands) |
|
|
|
|
|
|
2017 |
|
2016 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash,
cash equivalents, and marketable |
|
|
|
|
|
|
|
|
|
|
|
|
securities, including restricted |
|
|
|
|
|
|
$ |
60,691 |
|
|
$ |
38,932 |
|
|
Other
current assets |
|
|
|
|
|
|
|
15,626 |
|
|
|
8,935 |
|
|
Total
current assets |
|
|
|
|
|
|
|
76,317 |
|
|
|
47,867 |
|
|
Long-term investments |
|
|
|
|
|
|
|
2,209 |
|
|
|
2,046 |
|
|
Property
and equipment, net |
|
|
|
|
|
|
|
606 |
|
|
|
1,173 |
|
|
Other
assets |
|
|
|
|
|
|
|
1,362 |
|
|
|
1,198 |
|
|
Total
assets |
|
|
|
|
|
|
$ |
80,494 |
|
|
$ |
52,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
$ |
16,917 |
|
|
$ |
7,145 |
|
|
Stockholders' equity |
|
|
|
|
|
|
|
63,577 |
|
|
|
45,139 |
|
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
80,494 |
|
|
$ |
52,284 |
|
|
|
|
|
|
|
|
|
|
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