Vical Reports First Quarter 2018 Financial and Operational Results
May 03 2018 - 6:30AM
Vical Incorporated (Nasdaq:VICL) today reported financial results
for the three months ended March 31, 2018. Net loss for the first
quarter of 2018 was $6.3 million, or $0.29 per share, compared with
a net loss of $2.8 million, or $0.25 per share, for the first
quarter of 2017. Revenues for the first quarter of 2018 were $0.7
million, compared with revenues of $3.2 million for the first
quarter of 2017, reflecting revenues from Astellas Pharma Inc. for
services performed under ASP0113 collaborative agreements.
Vical had cash and investments of $58.3 million
at March 31, 2018. The Company’s cash burn for the first quarter of
2018 was $4.6 million, which was consistent with the Company’s full
year 2018 guidance of between $20 million and $24 million.
Program updates include:
VCL-HB01 HSV-2 Therapeutic Vaccine
- Vical expects to announce top-line results from a Phase 2 study
of its HSV-2 therapeutic vaccine during the second quarter of 2018.
The last subject in the study has now completed nine months of
surveillance; the primary endpoint of annualized recurrence rate
will be calculated based on recurrences that are both clinically-
and virologically-confirmed. This endpoint provides important
information on the number of genital lesion recurrences over time
in this chronic disease setting and is clinically meaningful for
both patients and treating physicians. The Phase 2 study is being
conducted in HSV-2 seropositive healthy adult subjects, 18 to 50
years of age who are randomized 2:1 to receive either vaccine or
placebo.
VL-2397 Antifungal Drug
- During the first quarter of 2018, Vical initiated a Phase 2
trial comparing VL‑2397 to standard first-line treatment for
invasive aspergillosis in immunocompromised adults with acute
leukemia or recipients of an allogeneic hematopoietic cell
transplant (ClinicalTrials.gov Identifier: NCT03327727). The
Company intends to conduct the trial in approximately 40 major
cancer and transplantation centers in North America, Europe and
Asia. The FDA has advised that VL‑2397 would be eligible for a
Limited Use Indication (LUI) approval for the treatment of invasive
aspergillosis for patients with limited treatment options. The FDA
has also granted Vical Qualified Infectious Disease Product (QIDP),
Orphan Drug and Fast Track designations for VL‑2397 for the
treatment of invasive aspergillosis. Only one new class of
antifungal therapy has been approved in the last 30 years. VL-2397
has a novel mechanism of antifungal action and could be the first
therapeutic in a new class of antifungals. VL-2397 was isolated
from a leaf litter fungus in a Malaysian national park, and was
in‑licensed from Astellas in 2015.
Hepatitis B Virus (HBV) Therapeutic
Drug
- The Company is pursuing preclinical development of a novel
treatment for chronic HBV infection based on its DNA and
lipid-delivery technologies. The initial aim of this program will
be to demonstrate proof of concept for inhibiting HBV infection in
an in vivo model. This preclinical development effort is being
conducted in collaboration with Vical’s partner, AnGes, Inc. of
Osaka, Japan.
Vical will conduct a conference call and webcast
today, May 3, 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)794-2567 (preferred), or (888)278-8469
(toll-free), and reference confirmation code 1443635. 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
1443635. 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 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.
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VICAL
INCORPORATED |
|
Selected Condensed Financial Information
(Unaudited) |
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Three Months Ended |
|
Statements of Operations |
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March 31, |
|
(in
thousands, except per share amounts) |
|
|
2018 |
|
2017 |
|
Revenues: |
|
|
|
|
|
|
|
|
Contract revenue |
|
|
$ |
706 |
|
|
$ |
2,901 |
|
|
License and royalty revenue |
|
|
|
10 |
|
|
|
304 |
|
|
Total
revenues |
|
|
|
716 |
|
|
|
3,205 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
|
3,664 |
|
|
|
3,300 |
|
|
Manufacturing and production |
|
|
|
1,436 |
|
|
|
1,309 |
|
|
General and administrative |
|
|
|
2,117 |
|
|
|
1,509 |
|
|
Total
operating expenses |
|
|
|
7,217 |
|
|
|
6,118 |
|
|
Loss from operations |
|
|
|
(6,501 |
) |
|
|
(2,913 |
) |
|
Net investment and other income |
|
|
|
231 |
|
|
|
89 |
|
|
Net
loss |
|
|
$ |
(6,270 |
) |
|
$ |
(2,824 |
) |
|
Basic
and diluted net loss per share |
|
|
$ |
(0.29 |
) |
|
$ |
(0.25 |
) |
|
Weighted
average shares used in computing |
|
|
|
|
|
|
|
|
basic and diluted net loss per share |
|
|
21,828 |
|
|
11,101 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets |
|
|
|
|
|
|
March 31, |
|
December 31, |
|
(in
thousands) |
|
|
|
|
|
|
2018 |
|
2017 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
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Cash, cash equivalents, and marketable |
|
|
|
|
|
|
|
|
|
|
|
|
securities, including restricted |
|
|
|
|
|
|
$ |
56,116 |
|
|
$ |
60,691 |
|
|
Other current assets |
|
|
|
|
|
|
|
1,445 |
|
|
|
15,626 |
|
|
Total
current assets |
|
|
|
|
|
|
|
57,561 |
|
|
|
76,317 |
|
|
Long-term investments |
|
|
|
|
|
|
|
2,176 |
|
|
|
2,209 |
|
|
Property
and equipment, net |
|
|
|
|
|
|
|
562 |
|
|
|
606 |
|
|
Other
assets |
|
|
|
|
|
|
|
1,075 |
|
|
|
1,362 |
|
|
Total
assets |
|
|
|
|
|
|
$ |
61,374 |
|
|
$ |
80,494 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
$ |
3,156 |
|
|
$ |
16,917 |
|
|
Stockholders' equity |
|
|
|
|
|
|
|
58,218 |
|
|
|
63,577 |
|
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
61,374 |
|
|
$ |
80,494 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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Contacts: Andrew
Hopkins
Anthony
Ramos
(858) 646-1127
Vice President and
Chief Financial
Officer
Website: www.vical.com
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