-----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, FtFDUhbuxNAMgyADJPk4OTLku458KvXlX1DBLmaW+hkGHcSayqz5IlgLeToptIoe q6Rq6Jwt4sesSjU9MYb4rg== 0001171843-09-000146.txt : 20090217 0001171843-09-000146.hdr.sgml : 20090216 20090217063102 ACCESSION NUMBER: 0001171843-09-000146 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090217 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090217 DATE AS OF CHANGE: 20090217 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: 09606845 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 17, 2009


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 17, 2009, Vical Incorporated issued a press release announcing, among other things, its unaudited financial results for the three months and twelve months ended December 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 February 17, 2009.


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

Dated: February 17, 2009 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 17, 2009.

EX-99.1 2 newsrelease.htm PRESS RELEASE Vical Reports 2008 Financial Results and Progress in Product Development Programs

EXHIBIT 99.1

Vical Reports 2008 Financial Results and Progress in Product Development Programs

SAN DIEGO, Feb. 17, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today reported financial results for the year ended December 31, 2008. Vical had cash and investments of approximately $42 million at year-end 2008, including approximately $5 million invested in long-term auction rate securities.

Revenues for 2008 were $8.0 million, compared with revenues of $5.5 million for 2007. The net loss for 2008 was $36.9 million, or $0.93 per share, compared with a net loss of $35.9 million, or $0.92 per share, for 2007. The net loss and the cash burn for 2008 were both consistent with the company's prior guidance.

Revenues for the fourth quarter of 2008 were $2.6 million, compared with revenues of $0.8 million for the fourth quarter of 2007. The net loss for the fourth quarter of 2008 was $9.0 million or $0.22 per share, compared with $8.9 million or $0.23 per share for the fourth quarter of 2007.

The company is projecting a net loss for 2009 of between $24 million and $28 million and a net cash burn for 2009 of between $19 million and $23 million, and expects to have cash and investments of $19 million to $23 million at year-end 2009.

Significant developments during the fourth quarter of 2008 included:



 * Completion of enrollment in a Phase 2 trial of Vical's therapeutic
   DNA vaccine designed to prevent cytomegalovirus (CMV) reactivation
   and disease in immunosuppressed bone marrow or stem cell transplant
   recipients, and an interim analysis of immunogenicity data for the
   first 33 transplant recipients in the recipient-only arm of the
   study showing significant (p less than 0.05) post-transplant
   enhancement of CMV-specific T-cell responses in subjects receiving
   vaccine compared with subjects receiving placebo.

 * A $1.0 million milestone payment from Merck & Co., Inc. related to
   initiation of a Phase 1 clinical trial of an investigational DNA
   cancer vaccine encoding human telomerase reverse transcriptase
   (hTERT);

 * An exclusive, binding letter of intent with a leading Turkish
   pharmaceutical company, Eczacibasi Ilac Pazarlama A.S. (EIP), for
   sales and marketing of the company's Allovectin-7(r)
   immunotherapeutic product candidate in Turkey and the Turkish
   Republic of Northern Cyprus;

 * A $1.3 million contract with the Naval Medical Research Center for
   manufacturing, regulatory and clinical support for preclinical and
   Phase 1 evaluation by the U.S. Navy and the U.S. Army of a
   Vaxfectin(r)-formulated DNA vaccine to protect against dengue, a
   tropical disease spread by mosquitoes that infects up to 100
   million people each year and causes tens of thousands of deaths;

 * Expanded data from a Phase 1 clinical trial of the company's
   Vaxfectin(r)-formulated H5N1 pandemic influenza DNA vaccines
   showing sustained antibody responses, T-cell responses against a
   matching strain of influenza virus and cross-clade antibody
   responses against a different strain; and

 * Publication of data from a Phase 1 clinical trial conducted by the
   NIH of a DNA vaccine for Severe Acute Respiratory Syndrome (SARS)
   demonstrating that the vaccine was well-tolerated and induced both
   neutralizing antibody responses and T-cell immune responses.

Highlights to date in 2009 include:



 * Issuance of U.S. Patent No. 7,470,675 covering the composition,
   delivery and use of gene-based interferon-omega, which may help
   direct and control the immune system; and

 * Receipt of a $2.3 million cash payment from AnGes MG, Inc., for
   continued funding of the company's ongoing Allovectin-7(r) Phase 3
   metastatic melanoma trial.

Anticipated program highlights for 2009 include:



 * Completion of enrollment by year-end 2009 in the company's Phase 3
   trial of its Allovectin-7(r) immunotherapeutic in patients with
   advanced metastatic melanoma;

 * Clinical results in the second quarter of 2009 from a Phase 2 trial
   of the company's CMV vaccine candidate for patients undergoing bone
   marrow or stem cell transplants;

 * Marketing approval in Japan for the company's licensee, AnGes MG,
   Inc., for Collategene(tm), a treatment using DNA-based delivery of
   Hepatocyte Growth Factor (HGF), an angiogenic growth factor, for
   patients with advanced peripheral arterial disease or Buerger's
   disease;

 * An update by the company's licensee, sanofi aventis Group, on an
   ongoing Phase 3 trial for the DNA-based delivery of Fibroblast
   Growth Factor 1 (FGF-1), an angiogenic growth factor, intended to
   promote the growth of blood vessels in patients with reduced blood
   flow to the limbs to reduce the need for amputations; and

 * Full U.S. approval for the company's licensee, Merial Limited, a
   joint venture of Merck and sanofi-aventis, to market a therapeutic
   DNA vaccine designed to treat melanoma in dogs.

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 17, 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 (866) 316-1372, or (913) 312-1272 for international participants, and reference confirmation code 7493461. 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 7493461. 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.

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 projections, as well as statements about the company's Allovectin-7(r), CMV and pandemic influenza vaccine programs, the company's Vaxfectin(r) adjuvant, and other independent and collaborative programs. Risks and uncertainties include whether Vical or others will continue development of Allovectin-7(r), the CMV vaccine, the pandemic influenza vaccine, the Vaxfectin(r) adjuvant, or any other independent or collaborative programs; whether Vical will announce clinical results from the Phase 2 CMV vaccine in the second quarter, if at all; whether Vical will complete enrollment in the Allovectin-7(r) Phase 3 trial by year-end 2009, if at all; whether Vical will receive all of the clinical trial funding committed by AnGes, which will depend on continued development of Allovectin-7(r) and ce rtain other conditions; whether gene-based interferon-omega, if used in human clinical trials, will be safe and effective at directing and controlling the immune system; whether the company's issued patents will be challenged and whether such challenges will have an adverse effect on the scope of the patents; whether the company will enforce its issued patents or will be successful in any enforcement efforts; whether AnGes will receive marketing approval for Collategene(tm) in Japan in 2009, if at all; whether sanofi aventis will provide an update on its ongoing FGF-1 Phase 3 trial in 2009, if at all; whether Merial will receive full U.S. marketing approval for its melanoma vaccine for dogs; whether Vical will achieve levels of revenues and control expenses to meet projected financial performance and net cash burn; 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)

                                Three Months Ended  Twelve Months Ended
 Statements of Operations            Dec. 31,            Dec. 31,
                                ------------------  ------------------
 (in thousands, except per        2008      2007      2008      2007
  share amounts)                --------  --------  --------  --------

 Revenues:
  Contract and grant revenue    $    542  $    580  $  2,146  $  4,574
  License and royalty revenue      2,083       191     5,810       938
                                --------  --------  --------  --------
 Total revenues                    2,625       771     7,956     5,512
                                --------  --------  --------  --------
 Operating expenses:
  Research and development         6,248     5,620    25,532    22,934
  Manufacturing and production     2,274     2,728    11,046    13,762
  General and administrative       2,282     2,253     8,721     9,078
                                --------  --------  --------  --------
 Total operating expenses         10,804    10,601    45,299    45,774
                                --------  --------  --------  --------
  Loss from operations            (8,179)   (9,830)  (37,343)  (40,262)
  Net investment (loss) income      (845)      969       447     4,368
                                --------  --------  --------  --------
 Net loss                       $ (9,024) $ (8,861) $(36,896) $(35,894)
                                ========  ========  ========  ========
 Basic and diluted net loss per
  share                         $  (0.22) $  (0.23) $  (0.93) $  (0.92)
                                ========  ========  ========  ========
 Weighted average shares used
  to calculate basic and
  diluted net loss per share      40,356    39,195    39,856    39,190
                                ========  ========  ========  ========


 Balance Sheets                             December 31,  December 31,
 (in thousands)                                 2008          2007
                                            ------------  ------------
 Assets:
  Cash, cash equivalents, and marketable
   securities                               $     36,266  $     71,489
  Other current assets                             1,852         1,261
                                            ------------  ------------
   Total current assets                           38,118        72,750
  Marketable securities                            5,410            --
  Property and equipment, net                     10,734        12,287
  Other assets                                     4,795         5,548
                                            ------------  ------------
 Total assets                               $     59,057  $     90,585
                                            ============  ============

 Liabilities and stockholders' equity:
  Current liabilities                       $      7,974  $      8,108
  Long-term obligations                            2,469         2,565
  Stockholders' equity                            48,614        79,912
                                            ------------  ------------
 Total liabilities and stockholders'
  equity                                    $     59,057  $     90,585
                                            ============  ============
CONTACT:  Vical Incorporated
          Alan R. Engbring, Executive Director, Investor Relations
          Jill M. Broadfoot, Senior Vice President and Chief Financial
           Officer
          (858) 646-1127
          www.vical.com
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