Vical Reports First Quarter 2013 Financial Results and Progress in Key Development Programs

Vical Reports First Quarter 2013 Financial Results and Progress in Key
Development Programs

SAN DIEGO, May 9, 2013 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL)
today reported financial results for the quarter ended March 31, 2013.
Revenues decreased to $1.6 million for the first quarter of 2013 compared with
$11.5 million for the first quarter of 2012, primarily as a result of the
recognition in 2012 of a $10 million milestone payment from Astellas Pharma
Inc. for progress with TransVax™, Vical's therapeutic vaccine designed to
control cytomegalovirus (CMV) in transplant recipients.

Net loss was $9.3 million, or $0.11 per share, for the first quarter of 2013,
compared with net income of $0.2 million, which rounds to $0.00 per share, for
the first quarter of 2012. Vical had cash and investments of approximately $78
million at March 31, 2013. The company's first quarter 2013 net cash use was
consistent with the company's prior guidance for the full year.

Program highlights include:

Allovectin^®

The company is approaching completion of a Phase 3 registration trial of its
investigational immunotherapy, Allovectin^®, vs. chemotherapy in patients with
metastatic melanoma.

  *A survival data sweep conducted in March 2013 confirmed that the target
    number of death events for the secondary endpoint (overall survival)
    should be reached in mid-2013.
  *The independent assessment and adjudication process for the primary
    endpoint (response rate at 24 weeks or more after randomization) is
    advancing through final audits and quality checks, and the company expects
    the adjudicated response data to be locked in July 2013.
  *Data for both endpoints will remain blinded in separate third-party
    databases and be securely transferred to Vical and unblinded
    simultaneously. Top-line results for both endpoints are expected to be
    released during the third quarter of 2013.

TransVax™ CMV Vaccine

  *Astellas is planning to initiate a Phase 3 trial of TransVax™ for
    hematopoietic cell transplant (HCT) recipients in the second quarter of
    2013 and to initiate a Phase 2 trial of TransVax™ for solid organ
    transplant (SOT) recipients soon afterward.

Herpes Simplex Vaccine

  *The company is planning to initiate a Phase 1/2 clinical trial of its
    Vaxfectin^®-formulated therapeutic vaccine against herpes simplex virus
    type 2 (HSV-2) in the second half of 2013.

Vaxfectin^®

  *The company announced the online publication of Baxter's (Baxter
    International Inc.) preclinical evaluations of Vical's Vaxfectin^®
    adjuvant in combination with Baxter's seasonal and pandemic influenza
    vaccines. Simple addition of Vaxfectin^® to the influenza vaccines
    substantially increased both antibody and T-cell responses compared with
    nonadjuvanted vaccines in mice and guinea pigs.

Conference Call

Vical will conduct a conference call and webcast today, May 9, at noon Eastern
Time, to discuss with invited analysts and institutional investors 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 (719)
325-2469 (preferred), or (888) 523-1228 (toll-free), and reference
confirmation code 5720239. 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
5720239. 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 researches and develops biopharmaceutical products based on its patented
DNA delivery technologies for the prevention and treatment of serious or
life-threatening diseases. Potential applications of the company's DNA
delivery technology include DNA vaccines for infectious diseases or cancer, in
which the expressed protein is an immunogen; cancer immunotherapeutics, in
which the expressed protein is an immune system stimulant; and cardiovascular
therapies, in which the expressed protein is an angiogenic growth factor. The
company is developing certain infectious disease vaccines and cancer
therapeutics internally. In addition, the company collaborates with major
pharmaceutical companies and biotechnology companies that give it access to
complementary technologies or greater resources. These strategic partnerships
provide the company with mutually beneficial opportunities to expand its
product pipeline and address significant unmet medical needs. 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 initiation and completion of clinical trials and the release of
clinical trial results. Risks and uncertainties include whether Vical or
others will continue development of Allovectin^®, TransVax™, the HSV-2
vaccine, or any other independent or collaborative programs; whether the
target number of death events for the secondary endpoint (overall survival) in
the company's Phase 3 Allovectin^® trial will be reached in mid-2013, if at
all; whether the adjudicated response data in the company's Phase 3
Allovectin^® trial will be locked in July 2013, if at all; whether the company
will release top-line data from the company's Phase 3 Allovectin^® trial
during the third quarter of 2013, if at all; whether Astellas will initiate
the planned HCT trial of TransVax™ in the second quarter of 2013, if at all,
and the planned SOT trial of TransVax™ soon afterward, if at all; whether
Vical or others will initiate a Phase 1/2 clinical trial of the HSV-2 vaccine
in the second half of 2013, if at all; whether Vical, Baxter or others will
develop any seasonal or pandemic influenza vaccines using Vical's Vaxfectin^®
adjuvant; whether Vical will achieve levels of revenues and control expenses
to meet its financial projections; whether any product candidates will be
shown to be safe and efficacious in clinical trials; 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.

VICAL INCORPORATED
Selected Condensed Financial Information (Unaudited)
                                                                
Statements of Operations                               Three Months Ended
                                                       March 31,
(in thousands, except per share amounts)               2013       2012
Revenues:                                                        
Contract and grant revenue                             $1,136   $1,221
License and royalty revenue                            438       10,239
Total revenues                                         1,574     11,460
Operating expenses:                                              
Research and development                               3,650     6,428
Manufacturing and production                           3,713     2,472
General and administrative                             3,518     2,700
Total operating expenses                               10,881    11,600
Loss from operations                                   (9,307)   (140)
Net investment and other income                        25        384
Net income (loss)                                      $(9,282) $244
Basic net income (loss) per share                      $(0.11)  $0.00
Diluted net income (loss) per share                    $(0.11)  $0.00
Weighted average shares used in basic net income       86,638    84,519
(loss) calculation
Weighted average shares used in diluted net income     86,638    86,124
(loss) calculation
                                                                
Balance Sheets                                         March 31,  December 31,
(in thousands)                                         2013       2012
Assets:                                                          
Cash, cash equivalents, and marketable securities,     $75,437  $83,857
including restricted
Other current assets                                   2,390     2,152
Total current assets                                   77,827    86,009
Long-term investments                                  2,197     2,225
Property and equipment, net                            5,042     5,284
Other assets                                           2,933     3,004
Total assets                                           $87,999  $96,522
                                                                
Liabilities and stockholders' equity:                            
Current liabilities                                    $5,276   $5,779
Long-term liabilities                                  1,569     1,657
Stockholders' equity                                   81,154    89,086
Total liabilities and stockholders' equity             $87,999  $96,522

CONTACT: Alan R. Engbring
         (858) 646-1127
         Website:  www.vical.com

Vical Logo
 
Press spacebar to pause and continue. Press esc to stop.