-----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, UMYM/PBsc7UXv4OiB6GxlMtqZKIgwlhihD1hFGtD0iGDlVIYk05bGUEE6XfVnWg1 L8s75dyP7Z4/ax63+V6wEQ== 0001144204-07-057215.txt : 20071031 0001144204-07-057215.hdr.sgml : 20071030 20071031063719 ACCESSION NUMBER: 0001144204-07-057215 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071031 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071031 DATE AS OF CHANGE: 20071031 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: 071201077 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 v091847_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): October 31, 2007
 
VICAL INCORPORATED
(Exact name of registrant as specified in charter)
 

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

10390 Pacific Center Court
San Diego, California
92121-4340
(Address of principal executive offices)
(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 October 31, 2007, Vical Incorporated issued a press release announcing, among other things, its unaudited financial results for the three months ended September 30, 2007. 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 October 31, 2007.
 
 
 
 

 
 
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: October 31, 2007  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 October 31, 2007.
 
 
 
 

 
EX-99.1 2 v091847_ex99-1.htm
 
 
10390 Pacific Center Court, San Diego, CA 92121-4340
858·646·1100, FAX: 858·646·1150
www.vical.com
News Release
 
FOR IMMEDIATE RELEASE
October 31, 2007

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

Vical Reports Third Quarter 2007 Financial Results
And Progress in Product Development Programs

SAN DIEGO—October 31, 2007—Vical Incorporated (Nasdaq:VICL) today reported financial results for the quarter ended September 30, 2007. The net loss for the third quarter of 2007 was $9.2 million or $0.24 per share, compared with $7.5 million or $0.24 per share for the third quarter of 2006.

Financial results were consistent with the company’s guidance of a projected net loss for the full year 2007 of between $32 million and $37 million, and a net cash burn for the full year, excluding equity investments, of $27 million to $32 million. Vical had cash and investments of $77 million at September 30, 2007.

Angiogenesis Programs
 
 
·
Sanofi-aventis initiated a 500-patient pivotal Phase 3 clinical trial of its NV1FGF angiogenesis therapy, which is based on Vical’s non-viral DNA delivery technology. Assuming successful completion of the trial, sanofi-aventis expects to file for marketing approval in 2010.

 
·
The company’s other angiogenesis licensee, AnGes MG, Inc. (AnGes), is preparing an application for Japanese marketing approval based on positive results following an interim efficacy evaluation in its Japanese Phase 3 trial of its gene-based Hepatocyte Growth Factor (HGF) product candidate in patients with advanced peripheral arterial disease (PAD).

CMV Phase 2 Trial
 
 
·
In October, an independent data safety monitoring board (DSMB) found no safety issues and recommended continuation of the company’s Phase 2 trial of a DNA vaccine against cytomegalovirus (CMV) in patients receiving hematopoietic stem cell transplants. The DSMB completed an interim evaluation of safety data after the two-month follow-up visits for the first 20 transplant recipients enrolled in the study.
 
Pandemic Influenza Phase 1 Trial
 
 
·
In August, Vical initiated a Phase 1 trial of the company’s Vaxfectin™-formulated plasmid DNA (pDNA) pandemic influenza vaccine. The double-blind, placebo-controlled trial is evaluating safety, tolerability and immune responses in up to 60 healthy volunteers. Vaccination of the first dose cohort has been completed with no safety issues, and the second dose cohort has been fully enrolled. Trial results are expected in the first half of 2008.

Vaxfectin™ Adjuvant
 
 
·
In October, the protein-based H5N1 pandemic influenza vaccine currently stockpiled by the U.S. government was shown to derive dose-sparing benefit from the company’s patented Vaxfectin™ adjuvant in a study in mice.

 
·
The company also reported that a measles DNA vaccine formulated with the company’s Vaxfectin™ adjuvant completely protected infant nonhuman primates following challenge one year after intradermal vaccination, with no clinical signs of disease and no culturable virus after challenge.

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, October 31, 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 1036247. 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 1036247. 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 the company’s CMV or pandemic influenza vaccine candidates, the company’s Vaxfectin™ adjuvant, the sanofi-aventis NV1FGF angiogenesis therapy, the NIH HIV vaccine candidate, or any other product candidates being developed by Vical, its collaborators or licensees; whether the CMV vaccine will achieve the safety and efficacy endpoints in the Phase 2 trial for stem cell transplant donors and recipients; whether the pandemic influenza vaccine will achieve the safety and immunogenicity endpoints in the Phase 1 trial; whether sanofi-aventis will complete the Phase 3 trial of its NV1FGF angiogenesis therapy and file for marketing approval in 2010, if at all; whether the company’s CMV or pandemic influenza vaccine candidates, the Vaxfectin™ adjuvant, the NV1FGF product candidate, the HIV vaccine candidate, 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 Sept. 30,  
 
 Nine Months Ended Sept. 30,  
 
(in thousands, except per share amounts)
 
2007
 
 2006
 
 2007
 
 2006
 
                      
Revenues:
                         
Contract and grant revenue
 
$
164
 
$
412
 
$
3,994
 
$
13,091
 
License and royalty revenue
   
211
   
154
   
747
   
346
 
Total revenues
   
375
   
566
   
4,741
   
13,437
 
Operating expenses:
                         
Research and development
   
5,580
   
4,038
   
17,314
   
12,853
 
Manufacturing and production
   
2,871
   
2,899
   
11,034
   
10,950
 
General and administrative
   
2,192
   
1,904
   
6,825
   
6,752
 
Total operating expenses
   
10,643
   
8,841
   
35,173
   
30,555
 
Loss from operations
   
(10,268
)
 
(8,275
)
 
(30,432
)
 
(17,118
)
Net investment income
   
1,029
   
766
   
3,399
   
1,892
 
Net loss
 
$
(9,239
)
$
(7,509
)
$
(27,033
)
$
(15,226
)
Basic and diluted net loss per share
 
$
(0.24
)
$
(0.24
)
$
(0.69
)
$
(0.52
)
Shares used to calculate basic and diluted net loss per share
   
39,193
    30,714     39,189     29,282  
 
Balance Sheets
          
 Sept. 30,
 
 December 31,
 
(in thousands)
          
2007 
 
2006
 
Assets:
                         
Cash, cash equivalents, and marketable securities
             
$
76,906
 
$
100,393
 
Other current assets
               
1,328
   
5,049
 
Total current assets
               
78,234
   
105,442
 
Property and equipment, net
               
12,808
   
13,500
 
Other assets
               
5,665
   
6,307
 
Total assets
             
$
96,707
 
$
125,249
 
 
                         
Liabilities and stockholders' equity:
                         
Current liabilities
             
$
5,768
 
$
8,153
 
Long-term obligations
               
2,649
   
2,973
 
Stockholders' equity
               
88,290
   
114,123
 
Total liabilities and stockholders' equity
             
$
96,707
 
$
125,249
 
 
#    #    #
 
 
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