0001171843-18-001968.txt : 20180315 0001171843-18-001968.hdr.sgml : 20180315 20180315063514 ACCESSION NUMBER: 0001171843-18-001968 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20180315 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20180315 DATE AS OF CHANGE: 20180315 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: 18690984 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_031518.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): March 15, 2018  

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 March 15, 2018, Vical Incorporated issued a press release announcing, among other things, its unaudited financial results for the three months ended December 31, 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 March 15, 2018.


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: March 15, 2018By: /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 March 15, 2018. 

EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFiling

EXHIBIT 99.1

Vical Reports Fourth Quarter 2017 Financial and Operational Results

SAN DIEGO, March 15, 2018 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today reported financial results for the three months ended December 31, 2017. Net loss for the fourth quarter of 2017 was $3.7 million, or $0.21 per share, compared with a net loss of $2.8 million, or $0.25 per share, for the fourth quarter of 2016. Revenues for the fourth quarter of 2017 were $4.0 million, compared with revenues of $3.2 million for the fourth quarter of 2016, reflecting revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements.

Vical had cash and investments of $62.9 million at December 31, 2017. The Company’s cash burn for 2017 was $8.6 million, which was consistent with the Company’s full year 2017 guidance of between $8 million and $11 million. The Company is projecting net cash burn for 2018 between $20 million and $24 million.

Program updates include:

VCL-HB01 HSV-2 Therapeutic Vaccine

  • Vical is developing an HSV-2 therapeutic vaccine, VCL-HB01, to treat subjects with symptomatic genital herpes infection. The vaccine is currently being evaluated in a Phase 2 study in HSV-2 seropositive 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 dosing was completed in July 2017. Following the 4th vaccination or placebo injection, each subject entered a 12-month surveillance period during which each new lesion recurrence is assessed in the clinic by the investigator. Once the last subject has completed a minimum of 9-months of surveillance, the primary endpoint of annualized recurrence rate will be calculated based on those recurrences that are both clinically- and virologically-confirmed. This endpoint provides important information on the number of recurrences over time in this chronic disease setting and is clinically meaningful for both patients and treating physicians. Vical expects to announce top-line results during the second quarter of 2018.

VL-2397 Antifungal Drug

  • In February, the Company initiated a Phase 2 trial of VL-2397 for the treatment of invasive aspergillosis. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis, assuming a successful outcome of a single Phase 2 trial carried out in accordance with a protocol and statistical analysis plan consistent with the Agency's advice. The final determination whether the drug is approvable will be made by FDA after review of all relevant data. Vical is collaborating with Mycoses Study Group Education and Research Consortium to advance VL-2397 for the treatment of invasive aspergillosis. The FDA has granted Vical Qualified Infectious Disease Product, Orphan Drug and Fast Track designations for VL-2397 for the treatment of invasive aspergillosis.

Hepatitis B Virus Therapeutic Drug

  • The Company is pursuing early stage development of a novel treatment for chronic hepatitis B virus (CHB) infection based on its DNA and lipid-delivery technologies. The initial aim of this program will be to demonstrate preclinical proof of concept for inhibiting HBV infection in a mouse model. The ultimate aim will be to demonstrate eradication of persistent HBV infection in CHB patients. This preclinical development effort is being conducted in collaboration with Vical’s strategic partner, AnGes, Inc. of Osaka, Japan.

ASP0113 CMV Therapeutic Vaccine

  • Astellas and Vical announced in January that ASP0113, a vaccine being developed for cytomegalovirus-seropositive hematopoietic stem cell transplant recipients, did not meet its primary or key secondary endpoints in the Phase 3 HELIOS clinical trial.  

Vical will conduct a conference call and webcast today, March 15, at noon Eastern Time, to discuss 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 (323)994-2083 (preferred), or (800)562-8369 (toll-free), and reference confirmation code 2848082. 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 2848082. 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, including antiviral and antifungal candidates in clinical development. 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,  anticipated developments in independent and collaborative programs, including the plans, timing of initiation, enrollment and announcement of data for clinical trials, as well as timing for potential regulatory submissions, and potential benefits of Vical’s product candidates. Risks and uncertainties include whether Vical or others will continue development of VCL-HB01, VL-2397 or any other independent or collaborative programs; the risk that the FDA does not grant LUI approval of VL-2397 following the results of Vical’s planned Phase 2 clinical trial; 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 approvals, allowances or guidance necessary to commercialize any product or to proceed with proposed clinical trials or implement anticipated clinical trial designs; whether on-going or planned clinical trials or regulatory submissions 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.

Contacts:        
Andrew Hopkins
(858) 646-1127 

Anthony Ramos
Vice President and Chief Financial Officer

Website:  www.vical.com


 

 VICAL INCORPORATED 
Selected Condensed Financial Information (Unaudited) 
             
 Three Months Ended Twelve Months Ended 
Statements of OperationsDecember 31, December 31, 
(in thousands, except per share amounts)2017
 2016  2017
 2016
 
Revenues:            
Contract revenue$3,943  $2,776  $13,401  $12,804  
License and royalty revenue 10   387   418   1,727  
Total revenues 3,953   3,163   13,819   14,531  
Operating expenses:            
Research and development 4,448   2,975   14,391   10,355  
Manufacturing and production 1,790   1,231   6,479   6,291  
General and administrative 1,596   1,732   6,335   7,062  
Total operating expenses 7,834   5,938   27,205   23,708  
Loss from operations (3,881)  (2,775)  (13,386)  (9,177) 
Net investment and other income 153   3   426   204  
Net loss$(3,728) $(2,772) $(12,960) $(8,973) 
Basic and diluted net loss per share$(0.21) $(0.25) $(1.01) $(0.90) 
Weighted average shares used in computing
 basic and diluted net loss per share
  17,778    11,103    12,888    10,019  
               
         
Balance Sheets      December 31, December 31, 
(in thousands)      2017
 2016
 
Assets:            
Cash, cash equivalents, and marketable            
securities, including restricted      $60,691  $38,932  
Other current assets       15,626   8,935  
Total current assets       76,317   47,867  
Long-term investments       2,209   2,046  
Property and equipment, net       606   1,173  
Other assets       1,362   1,198  
Total assets      $80,494  $52,284  
             
Liabilities and stockholders' equity:            
Current liabilities      $16,917  $7,145  
Stockholders' equity       63,577   45,139  
Total liabilities and stockholders' equity      $80,494  $52,284