-----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, VyYJ1rUd9uREQCuUGx0o0g8iGUO1gM66/Z8IkmTfluO1zTmtnSkCSigxfq9cR8ro qoNu5Q+0gFe/zXj9RBEFkg== 0001171843-11-000379.txt : 20110210 0001171843-11-000379.hdr.sgml : 20110210 20110210063054 ACCESSION NUMBER: 0001171843-11-000379 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20110210 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110210 DATE AS OF CHANGE: 20110210 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: 11589179 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 document.htm FORM 8-K FILING DOCUMENT Form 8-K Filing

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): February 10, 2011


Vical Incorporated
(Exact name of registrant as specified in its charter)


Delaware
 
000-21088
 
93-0948554
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (IRS 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):

  [   ] 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 February 10, 2011, Vical Incorporated issued a press release announcing, among other things, its unaudited financial results for the three months and twelve months ended December 31, 2010. 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 February 10, 2011.


SIGNATURES

    Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Vical Incorporated

Date: February 10, 2011 By:   /s/   JILL M. BROADFOOT
Jill M. Broadfoot
Senior Vice President, Chief Financial Officer and Secretary




INDEX TO EXHIBITS

Exhibit No. Description

99.1 Press release issued by Vical Incorporated on February 10, 2011.

EX-99.1 2 newsrelease.htm PRESS RELEASE Vical Reports 2010 Financial Results and Progress in Key Development Programs

EXHIBIT 99.1

Vical Reports 2010 Financial Results and Progress in Key Development Programs

SAN DIEGO, Feb. 10, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today reported financial results for the year ended December 31, 2010. Vical had cash and investments of approximately $61 million at year-end 2010. The company received approximately $37 million of net proceeds from the sale of equity securities during 2010.

Revenues for 2010 were $8.7 million, compared with revenues of $12.7 million for 2009. The net loss for 2010 was $30.4 million, or $0.51 per share, compared with a net loss of $28.6 million, or $0.61 per share, for 2009. The net cash burn for 2010, excluding cash received from financings, was approximately $29 million, compared with approximately $22 million for 2009. The company is projecting a net cash burn for 2011 of between $22 million and $27 million, including projected cash from new or expanded partnerships for which we do not currently have contracts.

Development highlights during 2010 included:

Allovectin-7®

  • Completion of enrollment in February 2010 in the company's pivotal Phase 3 trial of Allovectin-7® in patients with metastatic melanoma; and
     
  • Completion of the Phase 3 trial's fourth scheduled safety analysis by an independent Safety Monitoring Board and the recommendation that the trial continue per the protocol.

TransVax™ CMV Vaccine

  • Achievement of key efficacy, immunogenicity and safety results in a Phase 2 trial, establishing the TransVax™ cytomegalovirus (CMV) vaccine as the first to provide evidence of protection in immunocompromised hematopoietic cell transplant (HCT) recipients, and defining a potential pathway for further development.

Prophylactic CMV Vaccine

  • A five-year, $4.0 million grant to leading pediatric infectious disease researchers Stuart P. Adler, M.D., and Michael A. McVoy, Ph.D., of Virginia Commonwealth University (VCU) from the National Institutes of Health (NIH), to develop novel vaccine approaches designed to protect women of child-bearing potential from infection with CMV. Vical will produce the DNA vaccines and Vaxfectin® adjuvant, and will conduct the animal studies funded by the grant.

H1N1 Influenza Vaccine

  • Initiation of a U.S. government-funded Phase 1 trial of the company's Vaxfectin®-formulated DNA vaccine against H1N1 swine-origin pandemic influenza in collaboration with the U.S. Naval Medical Research Center (NMRC).

Herpes Simplex Vaccines

  • Protection against lethal challenge, sterilizing immunity and inhibition of viral counts at both the primary and latent infection sites in mice with the company's prophylactic Vaxfectin®-formulated DNA vaccine against herpes simplex virus type 2 (HSV-2). Significant reduction with a related vaccine of the recurrence of HSV-2 lesions in a therapeutic model using guinea pigs with latent infection.

Collaborations

  • The launch by the company's licensee Merial Limited, the animal health subsidiary of sanofi-aventis, of its ONCEPT™ canine melanoma vaccine, a therapeutic DNA vaccine designed to aid in extending survival of dogs with oral melanoma; and
     
  • Approval by the FDA of the Special Protocol Assessment (SPA) agreement for the company's licensee, AnGes MG, Inc., for a Phase 3 clinical trial of its Collategene™ angiogenesis product for patients with advanced peripheral arterial disease (PAD).

Manufacturing Contract

  • A $2.4 million contract to manufacture plasmid DNA (pDNA) vaccines against HIV for the IPPOX Foundation, a collaborating institution for the Poxvirus Vaccine Regimen Design (PVRD) led by the Centre Hospitalier Universitaire Vaudois (CHUV) under the auspices of the Collaboration for AIDS Vaccine Discovery (CAVD).

Anticipated program highlights for 2011 include:

  • Data in the first quarter of 2011 from the Phase 1 trial of the company's Vaxfectin®-adjuvanted DNA vaccine for H1N1 influenza;
     
  • Database lock in the second half of 2011 in the company's Phase 3 trial of Allovectin-7® in patients with metastatic melanoma;
     
  • Initiation in the second half of 2011 of a Phase 3 trial of the company's TransVax™ CMV vaccine candidate for HCT patients; and
     
  • Efforts by AnGes to expedite initiation of a multinational Phase 3 clinical trial of its Collategene™ angiogenesis product for patients with advanced PAD.

Conference Call

Vical will conduct a conference call and webcast today, February 10, 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 (913) 312-1493 (preferred), or (888) 710-4022 (toll-free), and reference confirmation code 3159114. 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 3159114. 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.

The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

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 loss and net cash burn guidance, as well as statements about Vical's Allovectin-7®, TransVax™, pandemic influenza vaccine and HSV-2 vaccine programs, the VCU prophylactic CMV vaccine program, the IPPOX HIV vaccine program, and other independent and collaborative programs, as well as anticipated developments in independent and collaborative programs, and statements about the scope of coverage of and potential applications for Vical's patents. Risks and uncertainties include whether Vical or others will continue development of Allovectin-7®, TransVax™, a prophylactic vaccine against congenital CMV infection, a vaccine against H1N1 pandemic influenza, prophylactic and therapeutic vaccines against HSV-2, the AnGes Collategene™ angiogenesis therapy, the IPPOX HIV vaccine, or any other independent or collaborative programs; whether Vical will release data from the H1N1 influenza vaccine Phase 1 trial in the first quarter of 2011, if at all; whether Vical will lock the database in the company's Phase 3 trial of Allovectin-7® in the second half of 2011, if at all; whether Vical will initiate a Phase 3 trial of TransVax™ for HCT patients in the second half of 2011, if at all; whether AnGes will expedite initiation of a multinational Phase 3 trial of Collategene™ for patients with advanced PAD in 2011, if at all; whether Vical will achieve levels of revenues and control expenses to meet its financial projections; whether Vical will enter into any new partnerships or expand any existing partnerships and receive all, if any, projected cash payments; 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 Dec. 31, Twelve Months Ended Dec. 31,
(in thousands, except per share amounts) 2010 2009 2010 2009
Revenues:        
Contract and grant revenue  $ 2,711  $ 949  $ 6,249  $ 3,692
License and royalty revenue  205  1,606  2,462  8,994
Total revenues  2,916  2,555  8,711  12,686
Operating expenses:        
Research and development  4,969  6,168  19,692  23,449
Manufacturing and production  2,893  1,887  11,436  10,354
General and administrative  2,325  1,914  8,798  7,469
Total operating expenses  10,187  9,969  39,926  41,272
Loss from operations  (7,271)  (7,414)  (31,215)  (28,586)
Net investment and other income  511  105  830  28
Net loss  $ (6,760)  $ (7,309)  $ (30,385)  $ (28,558)
Basic and diluted net loss per share  $ (0.09)  $ (0.14)  $ (0.51)  $ (0.61)
Shares used to calculate basic and diluted net loss per share  71,716  52,192  60,084  47,086
         
         
Balance Sheets     December 31, December 31,
(in thousands)     2010 2009
Assets:        
Cash, cash equivalents, and marketable securities, including restricted      $ 55,268  $ 47,085
Other current assets      940  1,349
Total current assets      56,208  48,434
Long-term investments      5,434  5,477
Property and equipment, net      7,560  9,260
Other assets      3,705  4,201
Total assets      $ 72,907  $ 67,372
         
Liabilities and stockholders' equity:        
Current liabilities      $ 6,334  $ 10,010
Long-term obligations      2,211  2,380
Stockholders' equity      64,362  54,982
Total liabilities and stockholders' equity      $ 72,907  $ 67,372
CONTACT: Alan R. Engbring
         Executive Director, Investor Relations
         Jill M. Broadfoot
         Senior Vice President and Chief Financial Officer
         (858) 646-1127
         Website: www.vical.com
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