Vical to Discontinue Clinical Development of VL-2397 as it Considers Near Term Strategic Alternatives
February 19 2019 - 5:45PM
Vical Incorporated (Nasdaq:VICL) today announced that it has
decided to discontinue the Phase 2 clinical trial of VL‑2397 that
was initiated in the first quarter of 2018. The decision was based
on the Company’s decision to conserve its cash resources while it
pursues its strategic alternative review process, as well as low
patient accrual rates. The Phase 2 clinical trial was
evaluating VL-2397 as a potential first-line treatment for invasive
aspergillosis in immunocompromised adults with acute leukemia or
recipients of an allogeneic hematopoietic cell transplant.
“While we believe in the potential benefits of
VL-2397, we have made a strategic decision to discontinue our
current development activities and conserve cash,”
stated Vijay Samant, chief executive officer at Vical.
“We want to thank the study investigators and their patients who
participated in the trial for their support.”
In the third quarter of 2018, Vical announced
plans to explore a range of strategic options to enhance
shareholder value. The Company retained MTS Health Partners, L.P.
to assist in the strategic review process. Given the decision
announced today, the Company will focus on concluding the
strategic review process.
Vical also plans to undertake a restructuring,
including an appropriate reduction in staff. As a result, the
Company will incur a restructuring related charge in the first
quarter of 2019.
Fourth Quarter 2018 Financial and
Operating Results
Vical also reported financial results for the
three months ended December 31, 2018. Net loss for the fourth
quarter of 2018 was $3.6 million, or $0.17 per share, compared with
a net loss of $3.7 million, or $0.21 per share, for the fourth
quarter of 2017. Revenues for the fourth quarter of 2018 were $0.1
million, compared with revenues of $4.0 million for the fourth
quarter of 2017, reflecting revenues from Astellas Pharma Inc. for
services performed under the prior ASP0113 collaborative
agreements. Vical had cash and investments of $50.5 million at
December 31, 2018. The Company’s net cash burn for 2018 was $12.4
million. The Company will not provide additional cash guidance
until the strategic review process is complete.
About VicalVical develops
biopharmaceutical products for the prevention and treatment of
chronic or life-threatening infectious diseases. Additional
information on Vical is available at www.vical.com.
Forward-Looking StatementsThis
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
plans to complete a restructuring and the estimated impact on cash
resources, as well as Vical’s plans to complete its review of
strategic alternatives and the potential benefits of a strategic
transaction. Risks and uncertainties include whether the
termination of VL-2397 development and the planned restructuring
will have the intended impact of conserving cash resources, Vical’s
ability to identify potential strategic transactions and to
complete any transaction that it pursues; whether Vical will be
able to realize the expected benefits of any transaction; 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
Statements of Operations |
December 31, |
|
December 31, |
|
(in
thousands, except per share amounts) |
2018 |
|
2017 |
|
2018 |
|
2017 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue |
$ |
114 |
|
$ |
3,943 |
|
$ |
1,582 |
|
$ |
13,401 |
|
License
and royalty revenue |
|
10 |
|
|
10 |
|
|
40 |
|
|
418 |
|
Total
revenues |
|
124 |
|
|
3,953 |
|
|
1,622 |
|
|
13,819 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
2,558 |
|
|
4,448 |
|
|
12,327 |
|
|
14,391 |
|
Manufacturing and production |
|
- |
|
|
1,790 |
|
|
1,436 |
|
|
6,479 |
|
General
and administrative |
|
1,517 |
|
|
1,596 |
|
|
7,505 |
|
|
6,335 |
|
Total
operating expenses |
|
4,075 |
|
|
7,834 |
|
|
21,268 |
|
|
27,205 |
|
Loss from
operations |
|
(3,951) |
|
|
(3,881) |
|
|
(19,646) |
|
|
(13,386) |
|
Net
investment and other income |
|
346 |
|
|
153 |
|
|
3,392 |
|
|
426 |
|
Net
loss |
$ |
(3,605) |
|
$ |
(3,728) |
|
$ |
(16,254) |
|
$ |
(12,960) |
|
Basic
and diluted net loss per share |
$ |
(0.17) |
|
$ |
(0.21) |
|
$ |
(0.74) |
|
$ |
(1.01) |
|
Weighted
average shares used in computing |
|
|
|
|
|
|
|
|
|
|
|
|
basic and
diluted net loss per share |
21,844 |
|
17,778 |
|
21,842 |
|
12,888 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets |
|
|
|
|
|
|
December 31, |
|
December 31, |
|
(in
thousands) |
|
|
|
|
|
|
2018 |
|
2017 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash,
cash equivalents, and marketable |
|
|
|
|
|
|
|
|
|
|
|
|
securities, including restricted |
|
|
|
|
|
|
$ |
48,071 |
|
$ |
60,691 |
|
Other
current assets |
|
|
|
|
|
|
|
1,128 |
|
|
15,626 |
|
Total
current assets |
|
|
|
|
|
|
|
49,199 |
|
|
76,317 |
|
Long-term investments |
|
|
|
|
|
|
|
2,386 |
|
|
2,209 |
|
Property
and equipment, net |
|
|
|
|
|
|
|
100 |
|
|
606 |
|
Other
assets |
|
|
|
|
|
|
|
659 |
|
|
1,362 |
|
Total
assets |
|
|
|
|
|
|
$ |
52,344 |
|
$ |
80,494 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
$ |
3,581 |
|
$ |
16,917 |
|
Stockholders' equity |
|
|
|
|
|
|
|
48,763 |
|
|
63,577 |
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
52,344 |
|
$ |
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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