0001171843-17-004797.txt : 20170808 0001171843-17-004797.hdr.sgml : 20170808 20170808063515 ACCESSION NUMBER: 0001171843-17-004797 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20170808 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170808 DATE AS OF CHANGE: 20170808 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: 171013170 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 f8k_080817.htm FORM 8-K
 

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): August 8, 2017  

VICAL INCORPORATED
(Exact Name of Registrant as Specified in Charter)

DELAWARE 000-2108893-0948554
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)

 

10390 Pacific Center Court, San Diego, California 92121-4340
(Address of Principal Executive Offices) (Zip Code)

(858) 646-1100
(Registrant's telephone number, including area code)

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:

 [   ]  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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [   ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [   ]

 
 

Item 2.02. Results of Operations and Financial Condition.

On August 8, 2017, Vical Incorporated issued a press release announcing, among other things, its unaudited financial results for the three months ended June 30, 2017. 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 August 8, 2017.


SIGNATURE

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: August 8, 2017By: /s/ ANTHONY A. RAMOS        
  Anthony A. Ramos
  Chief Financial Officer
  


INDEX TO EXHIBITS

 

Exhibit No. Description
   
99.1 Press release issued by Vical Incorporated on August 8, 2017.

EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFiling

EXHIBIT 99.1

Vical Reports Second Quarter 2017 Financial and Operational Results

SAN DIEGO, Aug. 08, 2017 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today reported financial results for the three months ended June 30, 2017. Net loss for the second quarter of 2017 was $3.3 million, or $0.30 per share, compared with a net loss of $1.3 million, or $0.14 per share, for the second quarter of 2016. Revenues for the second quarter of 2017 were $3.4 million, compared with revenues of $4.1 million for the second quarter of 2016, reflecting revenues from Astellas Pharma Inc. for manufacturing services performed under ASP0113 collaborative agreements.

Vical had cash and investments of $37.3 million at June 30, 2017. The Company’s net cash burn for the first six months of 2017 was $3.6 million, which was consistent with the Company’s full year guidance of between $8 million and $11 million.

Program updates include:

ASP0113 CMV Therapeutic Vaccine

  • The multinational Phase 3 registration trial in HCT recipients completed enrollment in September 2016 with a total of 515 subjects and is nearing completion of the one year follow-up period. The primary endpoint of the trial is a composite of overall mortality and CMV end organ disease which will be assessed one year after transplantation. Astellas expects top-line data to be available in the first quarter of 2018. Vical and Astellas continue to make progress towards a potential BLA filing in 2018. Assuming a successful trial outcome, Astellas intends to commercialize ASP0113 in North America, Europe, and Asia.

VCL-HB01 HSV-2 Therapeutic Vaccine

  • Vical is developing a HSV-2 therapeutic vaccine to reduce lesion recurrences in patients with symptomatic genital herpes infection. Its VCL-HB01 vaccine encodes two full-length HSV-2 antigens gD and UL46, and is formulated with Vical’s proprietary adjuvant, Vaxfectin®. The vaccine is being evaluated in a Phase 2 study in healthy adult subjects, 18 to 50 years of age who are randomized 2:1 to receive either vaccine or placebo. Recruitment of 261 subjects at 15 U.S. clinical sites was completed in April 2017 and 4-dose vaccination series was completed in July 2017. All active subjects are currently being monitored for lesion recurrences during a 12-month follow-up period. The primary endpoint of the study is annualized recurrence rate which is a clinically meaningful endpoint for both patients and treating physicians as it provides important information on the number of recurrences over time in this chronic disease setting. Vical remains on target to deliver top-line results during the second quarter of 2018.

VL-2397 Antifungal

  • Vical is developing its novel antifungal, VL-2397, for the treatment of patients with invasive fungal infections.  Vical plans to conduct a Phase 2 efficacy study to evaluate VL-2397 for the treatment of invasive aspergillosis. This life-threatening infection typically affects the lungs of immunocompromised patients and represents a major unmet medical need given the high mortality rate despite availability of current antifungal therapies.  The FDA has granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations to VL-2397 for the treatment of invasive aspergillosis. Under the QIDP designation Vical has interacted intensively with the FDA on the design of the Phase 2 trial and in exploring an expedited development pathway for VL‑2397. The Company intends to initiate the trial in the fourth quarter of 2017.

Vical will conduct a conference call and webcast today, August 8, at noon Eastern Time, to discuss the Company’s financial results and program updates with invited participants. 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 (719)325-4771 (preferred), or (888)417-2254 (toll-free), and reference confirmation code 6860083. 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 6860083. The webcast will also 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 develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. 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. Forward-looking statements include net cash use guidance, as well as anticipated developments in independent and collaborative programs, including the plans, timing of initiation, enrollment and announcement of data for clinical trials. Risks and uncertainties include whether Vical or others will continue development of ASP0113, Vical’s HSV-2 vaccine, VL-2397 or any other independent or collaborative programs; whether Vical will achieve levels of revenues and control expenses to meet its financial projections; whether enrollment in on-going trials will continue at current rates; whether Vical or its collaboration partners will be able to obtain regulatory allowances or guidance necessary to proceed with proposed clinical trials or implement anticipated clinical trial designs; whether on-going or planned clinical trials will be initiated or completed on the timelines Vical currently expects, whether any product candidates will be shown to be safe and efficacious in clinical trials; whether Vical is able to continue its collaborative arrangements or enter into new ones; whether Vical will have access to sufficient capital to fund its planned development activities; 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) 
             
 Three Months Ended Six Months Ended 
Statements of OperationsJune 30, June 30, 
(in thousands, except per share amounts)2017  2016  2017  2016  
Revenues:            
  Contract revenue $   3,369   $   3,630   $   6,270   $   7,718  
  License and royalty revenue   52     492     356     1,008  
Total revenues   3,421     4,122     6,626     8,726  
Operating expenses:            
  Research and development   3,639     2,303     6,939     4,781  
  Manufacturing and production   1,602     1,221     2,911     4,067  
  General and administrative   1,591     1,919     3,100     3,709  
Total operating expenses   6,832     5,443     12,950     12,557  
  Loss from operations   (3,411)    (1,321)    (6,324)    (3,831) 
  Net investment and other income   91     66     180     153  
Net loss $   (3,320)  $   (1,255)  $   (6,144)  $   (3,678) 
Basic and diluted net loss per share $   (0.30)  $   (0.14)  $   (0.55)  $   (0.40) 
Weighted average shares used in computing            
  basic and diluted net loss per share  11,139    9,240    11,121    9,232  
         
         
Balance Sheets      June 30, December 31, 
(in thousands)      2017  2016  
Assets:            
  Cash, cash equivalents, and marketable            
  securities, including restricted       $   35,174   $   38,932  
  Other current assets         11,345     8,935  
Total current assets         46,519     47,867  
Long-term investments         2,159     2,046  
Property and equipment, net         749     1,173  
Other assets         1,356     1,198  
Total assets       $   50,783   $   52,284  
             
Liabilities and stockholders' equity:            
  Current liabilities       $   10,983   $   7,145  
  Stockholders' equity         39,800     45,139  
Total liabilities and stockholders' equity       $   50,783   $   52,284  
             


Contacts:

Andrew Hopkins
(858) 646-1127
Website:  www.vical.com

Anthony Ramos
Vice President and Chief Financial Officer