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Vical Reports Second Quarter 2018 Financial and Operational Results

SAN DIEGO, Aug. 07, 2018 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today reported financial results for the three months ended June 30, 2018. Net loss for the second quarter of 2018 was $4.9 million, or $0.22 per share, compared with a net loss of $3.3 million, or $0.30 per share, for the second quarter of 2017. Revenues for the second quarter of 2018 were $0.7 million, compared with revenues of $3.4 million for the second quarter of 2017, reflecting a decline in revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements.

Vical recently announced plans to explore a range of strategic options to enhance shareholder value. The company retained MTS Health Partners, L.P. to assist in the strategic review process. There is no set timetable for the review process and there can be no assurance that the process will result in a transaction.

Vical had cash and investments of $54.3 million at June 30, 2018. The Company’s cash burn for the second quarter of 2018 was $4.0 million, which was consistent with the Company’s full year 2018 guidance of between $20 million and $24 million.  The Company anticipates ending 2018 with a minimum of $40 million, which, in the absence of a strategic transaction, Vical believes to be sufficient to fund operations through the announcement of top-line data from its Phase 2 clinical trial of VL-2397, expected in 2020.

Program updates include:

VL-2397 Antifungal Candidate

  • The multinational Phase 2 registration trial comparing VL‑2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant is ongoing (ClinicalTrials.gov Identifier: NCT03327727). Vical expects to conduct the trial in approximately 40 major cancer and transplantation centers in North America, Europe and Asia. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis for patients with limited treatment options. The FDA has also granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL‑2397 for the treatment of invasive aspergillosis. VL-2397 has a novel mechanism of antifungal action and could be the first therapeutic in a new class of antifungals.

VR-CHB01 Hepatitis B Virus (HBV) Therapeutic Candidate

  • The Company is pursuing preclinical development of a novel treatment for chronic HBV infection based on its DNA and lipid-delivery technologies. The initial aim of this program will be to demonstrate proof of concept for inhibiting HBV infection in an in vivo model. The Company expects to complete the initial stage of preclinical development in the fourth quarter of 2018.

About Vical

Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, including antiviral and antifungal candidates. 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, sufficiency of current cash resources to fund future operations, anticipated developments in independent and collaborative programs, including the plans, timing of initiation, enrollment and announcement of data for clinical trials, timing for potential regulatory submissions, potential benefits of Vical’s product candidates, whether Vical or others will continue development of VR-CHB01, VL-2397 or any other independent or collaborative programs, as well as Vical’s plans to explore strategic alternatives and the potential benefits of a strategic transaction. Risks and uncertainties include whether Vical or others will continue development of VL-2397, VR-CHB01 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 Phase 2 clinical trial; whether Vical will achieve levels of revenues and control expenses to meet its financial projections; 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; Vical’s ability to identify potential strategic transactions and to complete any transaction that it pursues; whether Vical will be able to realize the expected benefits of any transaction; 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)2018  2017  2018  2017  
Revenues:            
Contract revenue$725  $3,369  $1,431  $6,270  
License and royalty revenue 10   52   20   356  
Total revenues 735   3,421   1,451   6,626  
Operating expenses:            
Research and development 3,602   3,639   7,266   6,939  
Manufacturing and production -   1,602   1,436   2,911  
General and administrative 2,261   1,591   4,378   3,100  
Total operating expenses 5,863   6,832   13,080   12,950  
Loss from operations (5,128)  (3,411)  (11,629)  (6,324) 
Net investment and other income 260   91   491   180  
Net loss$(4,868) $(3,320) $(11,138) $(6,144) 
Basic and diluted net loss per share$(0.22) $(0.30) $(0.51) $(0.55) 
Weighted average shares used in computing            
basic and diluted net loss per share21,837  11,139  21,834  11,121  
                 
                 
Balance Sheets      June 30, December 31, 
(in thousands)      2018
 2017
 
Assets:            
Cash, cash equivalents, and marketable            
securities, including restricted      $52,095  $60,691  
Other current assets       1,610   15,626  
Total current assets       53,705   76,317  
Long-term investments       2,237   2,209  
Property and equipment, net       165   606  
Other assets       659   1,362  
Total assets      $56,766  $80,494  
             
Liabilities and stockholders' equity:            
Current liabilities      $3,181  $16,917  
Stockholders' equity       53,585   63,577  
Total liabilities and stockholders' equity      $56,766  $80,494  
             


Contacts:  Andrew Hopkins  Anthony Ramos
   (858) 646-1127  Vice President and Chief Financial Officer
   Website:  www.vical.com   
       

Tuesday, August 7, 2018 - 06:30