Vical Announces Restructuring to Focus Resources on HSV-2 and Antifungal Clinical Programs
January 30 2018 - 4:15PM
Vical Incorporated (Nasdaq:VICL) today announced a restructuring to
conserve capital and to focus its efforts on VL-2397, its
antifungal drug product candidate which is entering a pivotal Phase
2 clinical trial in the first quarter of 2018, and on completing
its Phase 2 HSV-2 clinical trial. The restructuring includes a
reduction in staff of approximately 54%, from 74 to 34 employees.
The company is terminating all activities related to the ASP0113
program licensed to Astellas Pharma. The company believes its
currently available cash and investments will be adequate to fund
operations at least through 2019.
“We have carefully evaluated our organization
and priorities and are restructuring to extend our cash runway to
ensure that our promising HSV-2 vaccine candidate and VL-2397
antifungal drug product candidate is adequately resourced to
maximize shareholder value,” said Vijay Samant, Vical’s President
and Chief Executive Officer. “This has been a very difficult
process and we regret the impact this business decision has on our
departing employees. We greatly appreciate the hard work and
commitment they have shown Vical over the years and wish them the
very best in their future endeavors.”
Financial Guidance and Restructuring
ImpactVical expects to report that it ended 2017 with cash
and investments of approximately $60 to $65 million. The cash burn
for 2017 is expected to be at the low end of Vical’s guidance of $8
to $11 million. The company expects to incur personnel-related
restructuring charges of approximately $1.1 million in the first
quarter of 2018. The company will provide cash burn guidance for
2018 at its upcoming 2017 year-end financial results conference
call.
Pipeline Programs
VCL-HB01 HSV-2 Therapeutic
Vaccine
- Vical is developing the HSV-2 therapeutic vaccine, VCL-HB01, to
treat patients with symptomatic genital herpes infection. The
vaccine candidate is currently being evaluated in a Phase 2 study
in 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
4-dose vaccination series was completed in July 2017. Following the
4th vaccination, each subject entered a 12-month surveillance
period during which each new lesion recurrence is assessed in the
clinic by the investigator. Once all subjects have 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 remains on target to deliver top-line results during the
second quarter of 2018.
VL-2397 Antifungal
- Vical is developing its novel antifungal drug product
candidate, VL-2397, for the treatment of patients with invasive
fungal infections. 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. The Company intends to
initiate a Phase 2 trial of VL-2397 for the treatment of invasive
aspergillosis in the first quarter of 2018. In addition, the FDA
has granted Vical Qualified Infectious Disease Product, Orphan Drug
and Fast Track designations to VL-2397 for the treatment of
invasive aspergillosis.
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 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
anticipated restructuring charges, net cash use guidance, expected
cash and investment balances, as well as anticipated developments
in independent clinical programs, including the initiation and
completion of clinical trials. Risks and uncertainties include
whether Vical will effectively focus resources on its clinical
programs; whether Vical’s audited financial results will differ
from its estimates; whether Vical or others will continue
development of VCL-HB01 and 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 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 enter into new collaborative arrangements;
whether Vical will have access to sufficient capital to fund its
planned development activities; 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.
Contact:
Andrew
Hopkins
(858)
646-1127
Website: www.vical.com
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