-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, GTn0qdfA/aQSHnmmKYGnijaaqzZuVNCB9eSzBjJZIjmoTIauImCrFOyg7slM+17T hTxzO6sc6sJNiu6Ff7enLw== 0001144204-08-026761.txt : 20080508 0001144204-08-026761.hdr.sgml : 20080508 20080508063324 ACCESSION NUMBER: 0001144204-08-026761 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080508 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080508 DATE AS OF CHANGE: 20080508 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VICAL INC CENTRAL INDEX KEY: 0000819050 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 930948554 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21088 FILM NUMBER: 08811921 BUSINESS ADDRESS: STREET 1: 10390 PACIFIC CENTER COURT STREET 2: . CITY: SAN DIEGO STATE: CA ZIP: 92121-4340 BUSINESS PHONE: 858-646-1100 MAIL ADDRESS: STREET 1: 10390 PACIFIC CENTER COURT STREET 2: . CITY: SAN DIEGO STATE: CA ZIP: 92121-4340 8-K 1 v113161_8k.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549 
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
 
Date of report (Date of earliest event reported): May 8, 2008
 
VICAL INCORPORATED
(Exact name of registrant as specified in charter)
 

 
Delaware
(State or other
jurisdiction of
incorporation)
 
000-21088
(Commission File Number)
 
93-0948554
(I.R.S. Employer
Identification No.)

10390 Pacific Center Court
San Diego, California
(Address of principal executive offices)
 
 
92121-4340
(Zip Code)
 
Registrant’s telephone number, including area code: (858) 646-1100
 
Not Applicable.
(Former name or former address, if changed since last report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 

 
 
Item 2.02 Results of Operations and Financial Condition.
 
On May 8, 2008, Vical Incorporated issued a press release announcing, among other things, its unaudited financial results for the three months ended March 31, 2008. A copy of the press release is attached as Exhibit 99.1 to this Current Report.

The information in this Item 2.02, and Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
 
Item 9.01 Financial Statements and Exhibits.
 
(d) Exhibits.

 
99.1
Press release issued by Vical Incorporated on May 8, 2008.
 
 
 

 

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
  VICAL INCORPORATED
     
Date: May 8, 2008
By:
/s/ JILL M. CHURCH
   
Jill M. Church
   
Vice President, Chief Financial Officer and Secretary

 
 

 

INDEX TO EXHIBITS
 
Exhibit No.
 
Description
     
99.1
 
Press release issued by Vical Incorporated on May 8, 2008.

 
 

 
 
EX-99.1 2 v113161_ex99-1.htm Unassociated Document
 
FOR IMMEDIATE RELEASE
May 8, 2008

Alan R. Engbring
Jill M. Church
 
Executive Director, Investor Relations
Vice President and Chief Financial Officer
 
(858) 646-1127
 
 
Website: www.vical.com
 

Vical Reports First Quarter 2008 Financial Results
And Updates Key Development Programs

SAN DIEGO—May 8, 2008—Vical Incorporated (Nasdaq:VICL) today reported financial results for the quarter ended March 31, 2008. Revenues for the first quarter of 2008 were $1.9 million, compared with revenues of $1.3 million for the first quarter of 2007. The net losses for the first quarters of both 2008 and 2007 were $9.6 million, or $0.24 per share.

Vical had cash and investments of $60 million at March 31, 2008. The company’s first quarter 2008 financial results were consistent with its projection for a full year net loss of between $32 million and $37 million and a net cash burn of $27 million to $32 million.

Independent Development Program Highlights
 
 
·
The Phase 3 pivotal trial of the company’s Allovectin-7® immunotherapeutic is actively enrolling patients at nearly 50 sites in North America and Europe, and completion of enrollment is expected in mid-2009. The trial is being funded by cash payments and equity investments from AnGes MG, Inc.

 
·
The company’s Phase 2 trial of a vaccine designed to prevent cytomegalovirus (CMV) disease in patients undergoing hematopoietic cell transplants has exceeded 50% enrollment and is on schedule for release of interim efficacy data in the second half of 2008.

 
·
The company’s Phase 1 trial of its Vaxfectin®-formulated vaccine for pandemic influenza completed enrollment and final dosing on schedule and results will be released by August. The company’s novel Vaxfectin® adjuvant has demonstrated efficacy enhancement and dose-sparing ability in a variety of animal models. Vaxfectin® is currently being evaluated for additional vaccine applications by several potential partners.
 
 
·
The company was awarded a two-year, $2.0 million grant from the National Institutes of Health (NIH) to fund the ongoing development of Vical’s immunotherapeutic vaccine designed to reduce disease symptoms and viral shedding in patients already infected with herpes simplex virus type 2 (HSV-2), a sexually transmitted virus which is the leading cause of genital herpes. The HSV-2 vaccine will also be evaluated with Vical’s proprietary Vaxfectin® adjuvant.

Partnered Development Program Highlights
 
 
·
The company’s Japanese partner, the biotechnology company AnGes, submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare for its hepatocyte growth factor (HGF) angiogenesis product candidate, Collategene, for treatment of critical limb ischemia. AnGes is expected to pursue initiation of a Phase 3 registration trial with Collategene in the United States.

 
·
The company’s European partner, the large pharmaceutical company sanofi-aventis, is conducting a 500-patient Phase 3 pivotal trial of its fibroblast growth factor 1 (FGF-1) angiogenesis product candidate in key global markets and anticipates filing for marketing approvals in 2010.

Conference Call
 
Vical will conduct a conference call and webcast to discuss the financial results and program updates with invited analysts and institutional investors today, February 21, at noon Eastern Time. 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 (888) 600-4883, or (913) 312-6683 for international participants, and reference confirmation code 9467583. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (888) 203-1112, or (719) 457-0820 for international participants, and enter replay passcode 9467583. 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 info@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, including: whether Vical or others will continue development of Allovectin-7®, the company’s CMV vaccine candidate, the company’s pandemic influenza vaccine candidate, the company’s HSV-2 vaccine candidate, the company’s Vaxfectin® adjuvant, the angiogenesis product candidates, or any other product candidates being developed by Vical, its collaborators or licensees; whether the Allovectin-7® Phase 3 trial will complete enrollment in mid-2009; whether Vical will receive all of the clinical trial funding from AnGes under the collaborative agreement, which will depend on continued development of Allovectin-7® and certain other conditions, as well as AnGes' compliance with its contractual obligations under the agreement; whether the company’s Phase 2 CMV vaccine interim efficacy data will be available in the second half of 2008, if at all; whether the company’s Phase 1 pandemic influenza vaccine safety and immunogenicity data will be available by August 2008, if at all; whether all funding under the HSV-2 grant will be received by the company; whether the Vaxfectin® adjuvant will effectively enhance the performance of the HSV-2 vaccine; whether Collategene will be approved in Japan or enter a Phase 3 registration trial in the United States; whether sanofi aventis will successfully complete its Phase 3 trial of its FGF-1 angiogenesis product and, if so, whether filings for marketing approval will occur in 2010, if at all; whether Allovectin-7®, the company’s CMV, pandemic influenza or HSV-2 vaccine candidates, the angiogenesis product candidates, or any other product candidates being developed by Vical, its collaborators or licensees will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether the company will achieve levels of revenues and control expenses to meet projected financial performance; 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)
   
2008
   
2007
 
               
Revenues:
             
Contract and grant revenue
 
$
460
 
$
850
 
License and royalty revenue
   
1,480
   
405
 
Total revenues
   
1,940
   
1,255
 
Operating expenses:
             
Research and development
   
6,594
   
5,875
 
Manufacturing and production
   
3,106
   
3,947
 
General and administrative
   
2,335
   
2,293
 
Total operating expenses
   
12,035
   
12,115
 
Loss from operations
   
(10,095
)
 
(10,860
)
Net investment income
   
530
   
1,263
 
Net loss
 
$
(9,565
)
$
(9,597
)
Basic and diluted net loss per share
 
$
(0.24
)
$
(0.24
)
Shares used to calculate basic and diluted net loss per share
   
39,218
   
39,182
 
 
Balance Sheets
   
March 31,
   
December 31,
 
(in thousands)
   
2008
   
2007
 
               
Assets:
             
Cash, cash equivalents, and marketable securities
 
$
51,998
 
$
71,489
 
Other current assets
   
1,645
   
1,261
 
Total current assets
   
53,643
   
72,750
 
Marketable securities
   
8,228
   
-
 
Property and equipment, net
   
11,868
   
12,287
 
Other assets
   
5,296
   
5,548
 
Total assets
 
$
79,035
 
$
90,585
 
               
Liabilities and stockholders' equity:
             
Current liabilities
 
$
5,970
 
$
8,108
 
Long-term obligations
   
2,513
   
2,565
 
Stockholders' equity
   
70,552
   
79,912
 
Total liabilities and stockholders' equity
 
$
79,035
 
$
90,585
 

#           #          #

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-----END PRIVACY-ENHANCED MESSAGE-----