-----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, WKb2QWI8MjamlFRBqQnA+1Vez1BgbHw7PZsRBvXUu1poSvMnJMZFWJUdTZnr/DkE 4b4I0+CEazLr8SGNFjOXRg== 0001171843-10-000798.txt : 20100506 0001171843-10-000798.hdr.sgml : 20100506 20100506063016 ACCESSION NUMBER: 0001171843-10-000798 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100506 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100506 DATE AS OF CHANGE: 20100506 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: 10803866 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): May 6, 2010


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 May 6, 2010, Vical Incorporated issued a press release announcing, among other things, its unaudited financial results for the three months ended March 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 May 6, 2010.


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: May 6, 2010 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 May 6, 2010.

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

EXHIBIT 99.1

Vical Reports First Quarter 2010 Financial Results and Progress in Key Programs

SAN DIEGO, May 6, 2010 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today reported financial results for the quarter ended March 31, 2010. Revenues were $1.5 million for the first quarter of 2010 compared with $2.3 million for the first quarter of 2009, reflecting lower revenues under the company's license agreement with AnGes MG, Inc. Operating expenses were $10.1 million for the first quarter of 2010 compared with $10.6 million for the first quarter of 2009.

The net loss was $8.5 million, or $0.15 per share, for the first quarter of 2010, compared with $8.2 million, or $0.20 per share, for the first quarter of 2009. Vical had cash and investments of approximately $48 million at March 31, 2010. The company's first quarter 2010 net cash use was consistent with the company's prior guidance for the full year.

Development highlights to date in 2010 included:

  • Completion of enrollment in February with 390 total subjects in the company's pivotal Phase 3 trial of Allovectin-7® in patients with metastatic melanoma;
  • Enhanced cellular and antibody immune responses for the company's TransVax™ cytomegalovirus (CMV) vaccine vs placebo through the final 12-month immunogenicity data point in the ongoing Phase 2 trial in hematopoietic cell transplant (HCT) recipients;
  • Initiation of a Phase 1 clinical trial of the company's vaccine against H1N1 pandemic influenza with U.S. Navy funding;
  • 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;
  • Presentation of encouraging results from a Phase 1/2a clinical trial of a prime-boost vaccine regimen and publication of preclinical data demonstrating enhancement of immune responses with the company's Vaxfectin® adjuvant, both in collaboration with the U.S. military on DNA vaccines for malaria; and
  • Publication of Phase 1 results highlighting safety and tolerability, antibody responses in the same range as conventional vaccines, sustained immunogenicity, and cross-clade antibody responses for the company's H5N1 pandemic influenza vaccine.

Anticipated program highlights for the remainder of 2010 include:

  • Results of independent safety monitoring board review of the company's Phase 3 trial of Allovectin-7® in patients with metastatic melanoma;
  • Final results in the third quarter of 2010 from the Phase 2 trial of the company's TransVax™ CMV vaccine candidate for HCT patients;
  • Immunogenicity data from a Phase 1 trial of the company's Vaxfectin®-adjuvanted DNA vaccine for H1N1 influenza; and
  • Data in the fourth quarter of 2010 from the company's licensee, sanofi aventis Group, from the ongoing TAMARIS Phase 3 trial of Temusi®, intended to promote the growth of blood vessels to reduce the need for amputations in patients with reduced blood flow to the limbs.

Conference Call

Vical will conduct a conference call and webcast today, May 6, 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 (888) 280-4443, or (719) 325-2191 for international participants, and reference confirmation code 4067561. 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 4067561. 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 cash use guidance, as well as anticipated developments in independent and collaborative programs. Risks and uncertainties include whether Vical or others will continue development of Allovectin-7®, TransVax™, CyMVectin™, a vaccine against H1N1 pandemic influenza, Temusi®, Collategene™, ONCEPT™, or any other independent or collaborative programs; whether Vical will provide periodic progress reports on the company's Phase 3 Allovectin-7® trial; whether final results from the TransVax™ Phase 2 trial will be available in the third quarter of 2010, if at all; whether Vical will provide immunogenicity data from a Phase 1 trial of the company's H1N1 influenza vaccine; whether AnGes will initiate a Phase 3 clinical trial of its Colla tegene™ angiogenesis product in the United States; whether sanofi aventis will present data its ongoing Phase 3 trial of Temusi® in the fourth quarter of 2010, 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, anticipated 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
March 31,
(in thousands, except per share amounts) 2010 2009
     
Revenues:    
Contract and grant revenue  $586  $378
License and royalty revenue  877  1,872
Total revenues  1,463  2,250
Operating expenses:    
Research and development  5,102  6,221
Manufacturing and production  2,805  2,444
General and administrative  2,185  1,901
Total operating expenses  10,092  10,566
Loss from operations  (8,629)  (8,316)
Net investment and other income  151  72
Net loss  $(8,478)  $(8,244)
Basic and diluted net loss per share  $(0.15) $(0.20)
Shares used to calculate basic and diluted net loss per share  55,152  40,478
     
     
Balance Sheets  March 31, December 31,
(in thousands)  2010 2009
Assets:    
Cash, cash equivalents, and marketable securities, including restricted  $42,018  $47,085
Other current assets  1,800  1,349
Total current assets  43,818  48,434
Long-term investments  5,539  5,477
Property and equipment, net  8,789  9,260
Other assets  4,088  4,201
Total assets  $62,234  $67,372
     
Liabilities and stockholders' equity:    
Current liabilities  $7,856  $10,010
Long-term obligations  2,345  2,380
Stockholders' equity  52,033  54,982
Total liabilities and stockholders' equity $62,234  $67,372
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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