-----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, K2DmWictYQeUM9ySqODN4Dkwrwt3JBfmoy5CkPhRNotxHaoCa9XW8yMyrQz1HY06 yWfqiLzrRCCvNry8idvPcA== 0001144204-08-061103.txt : 20081105 0001144204-08-061103.hdr.sgml : 20081105 20081105063302 ACCESSION NUMBER: 0001144204-08-061103 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20081105 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081105 DATE AS OF CHANGE: 20081105 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: 081162323 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 v130689_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): November 5, 2008
 
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
(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):
 
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
¨
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 August 5, 2008, Vical Incorporated issued a press release announcing, among other things, its unaudited financial results for the three months and nine months ended September 30, 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 November 5, 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: November 5, 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 November 5, 2008.

 
 

 


EX-99.1 2 v130689_ex99-1.htm Unassociated Document
10390 Pacific Center Court, San Diego, CA 92121-4340
858·646·1100, FAX: 858·646·1150
www.vical.com
News Release

FOR IMMEDIATE RELEASE
November 5, 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 Third Quarter 2008 Financial Results
And Continued Progress in Product Development Programs

SAN DIEGO—November 5, 2008—Vical Incorporated (Nasdaq:VICL) today reported financial results for the quarter ended September 30, 2008. Revenues for the third quarter of 2008 were $0.8 million, compared with revenues of $0.4 million for the third quarter of 2007. The net loss for the third quarter of 2008 was $9.8 million or $0.24 per share, compared with $9.2 million or $0.24 per share for the third quarter of 2007.

Revenues for the first nine months of 2008 were $5.3 million, compared with revenues of $4.7 million for the first nine months of 2007. The net loss for the first nine months of 2008 was $27.9 million, or $0.70 per share, compared with a net loss of $27.0 million, or $0.69 per share, for the first nine months of 2007.

Vical had cash and investments of $49 million at September 30, 2008. The company’s third quarter 2008 financial results were consistent with its projection for a full year net loss of $32 million to $37 million and a net cash burn of $27 million to $32 million.

CMV Vaccine
During the third quarter, Vical achieved the milestone of enrolling the 80th stem cell transplant recipient in the company’s Phase 2 cytomegalovirus (CMV) vaccine trial. The company expects to announce during the fourth quarter the results of an interim analysis in this trial on those subjects who were enrolled by the end of March.

H5N1 Pandemic Influenza Vaccines
Vical and AnGes MG, Inc., signed a non-binding Letter of Intent in October indicating their mutual interest in licensing the development and marketing rights for Vical's Vaxfectin®-formulated H5N1 pandemic influenza DNA vaccines in Japan to AnGes. Vical reported in July that the company's pandemic influenza DNA vaccines achieved potentially protective levels of antibody responses (H5 hemagglutination inhibition, or HI, titers of at least 40 and at least a four-fold increase from baseline) in at least 50% and up to 67% of evaluable subjects in the higher dose cohorts in a 100-subject Phase 1 trial. Expanded data presented in October showed that in the highest dose cohorts, responses peaked by Day 56 and were sustained in 80% to 100% of the responders through the end of the study at Day 182.

Vaxfectin® Developments
In addition to the successful initial human application of the Vaxfectin® adjuvant in the H5N1 pandemic influenza vaccine program, Vaxfectin®-formulated DNA vaccines have been well-tolerated and have demonstrated significant immune responses in multiple animal models, including nonhuman primates. Vaxfectin® has also demonstrated a dose-sparing effect (the ability to achieve the same vaccine effectiveness with lower vaccine doses) with the commercial seasonal influenza and government-stockpiled H5N1 pandemic influenza vaccines. Vaxfectin® may have potential applications as an adjuvant for other protein-based vaccines against infectious diseases and cancer as well. The Vaxfectin® adjuvant is currently being evaluated by potential partners for a variety of additional vaccine applications, and continued progress was reported over the past few months, including:

 
·
New mouse data with Vaxfectin®-formulated seasonal influenza vaccines demonstrating the ability to adjust the ratio of Vaxfectin® to vaccine and drive substantial increases in either antibody or T-cell responses, without reducing the other type of response, compared with unformulated vaccine;

 
·
A mouse study demonstrating a 100-fold increase in antigen-specific CD8+ T-cell responses with a Vaxfectin®-formulated cancer vaccine compared with unformulated vaccine;

 
·
A research collaboration with the Karolinska Institutet and the Swedish Institute for Infectious Disease Control to evaluate a Vaxfectin®-formulated preventive DNA vaccine against HIV in a Phase 1 human clinical trial as part of a prime-boost regimen; and

 
·
Publication in the August issue of “Clinical and Vaccine Immunology” of results demonstrating long-term protection against measles challenge in juvenile and infant nonhuman primates with a Vaxfectin®-formulated DNA vaccine.
 
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, November 5, 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 (800) 817-4887, or (913) 312-1277 for international participants, and reference confirmation code 3255394. 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 3255394. 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 http://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 full-year net loss and net cash burn projections, as well as statements about the company's pandemic influenza and CMV vaccine programs, the company’s Vaxfectin® adjuvant, and other independent and collaborative programs. Risks and uncertainties include whether Vical or others will continue development of the CMV vaccine, the pandemic influenza vaccine, the Vaxfectin® adjuvant, or any other independent or collaborative programs; whether Vical will announce results of the Phase 2 CMV vaccine interim analysis in the fourth quarter, if at all; whether Vical will be able to complete a mutually satisfactory definitive agreement with AnGes; whether preliminary H5N1 DNA vaccine Phase 1 clinical trial results will be confirmed upon further analysis or in larger studies; whether Vaxfectin® or other results in animal studies can be duplicated in human clinical trials; whether nonclinical results will advance to human clinical testing, and if so, whether such testing will be successful; whether commercial partners or collaborators will pursue additional Vaxfectin® applications; whether the company will achieve levels of revenues and control expenses to meet projected financial performance; 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; the dependence of the company on its collaborative partners; 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)
 
2008
 
2007
 
2008
 
2007
 
                   
Revenues:
                         
Contract and grant revenue
 
$
711
 
$
164
 
$
1,604
 
$
3,994
 
License and royalty revenue
   
133
   
211
   
3,727
   
747
 
Total revenues
   
844
   
375
   
5,331
   
4,741
 
Operating expenses:
                         
Research and development
   
6,226
   
5,580
   
19,284
   
17,314
 
Manufacturing and production
   
2,716
   
2,871
   
8,772
   
11,034
 
General and administrative
   
2,087
   
2,192
   
6,439
   
6,825
 
Total operating expenses
   
11,029
   
10,643
   
34,495
   
35,173
 
Loss from operations
   
(10,185
)
 
(10,268
)
 
(29,164
)
 
(30,432
)
Net investment income
   
360
   
1,029
   
1,292
   
3,399
 
Net loss
 
$
(9,825
)
$
(9,239
)
$
(27,872
)
$
(27,033
)
Basic and diluted net loss per share
 
$
(0.24
)
$
(0.24
)
$
(0.70
)
$
(0.69
)
Weighted average shares used to calculate basic and diluted net loss per share
   
40,349
   
39,193
   
39,688
   
39,189
 
 
Balance Sheets   
September 30,
 
December 31,
 
(in thousands)
 
2008
 
2007
 
Assets:
             
Cash, cash equivalents, and marketable securities
 
$
43,022
 
$
71,489
 
Other current assets
   
1,649
   
1,2617
 
Total current assets
   
44,671
   
2,750
 
Marketable securities
   
6,000
   
-
 
Property and equipment, net
   
11,146
   
12,287
 
Other assets
   
4,948
   
5,548
 
Total assets
 
$
66,765
 
$
90,585
 
               
Liabilities and stockholders' equity:
             
Current liabilities
 
$
7,522
 
$
8,108
 
Long-term obligations
   
2,480
   
2,565
 
Stockholders' equity
   
56,763
   
79,912
 
Total liabilities and stockholders' equity
 
$
66,765
 
$
90,585
 
 
# # #
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