Item 8.01. Other Events.

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On October 2, 2017, Vical Incorporated issued a press release announcing that the U.S. Food and Drug Administration (FDA) has advised that Vical’s investigational antifungal VL‑2397 would be eligible for a Limited Use Indication (LUI) approval 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 plans to initiate a single Phase 2 trial for the treatment of invasive aspergillosis (IA) in acute leukemia patients andallogeneic hematopoietic cell transplant (HCT) recipients for whom alternative treatment regimens are not available in the fourth quarter of 2017. The global Phase 2 trial will be a non-inferiority study comparing VL-2397 to standard of care treatment for IA. Approximately 200 acute leukemia patients and recipients of allogeneic HCT will be enrolled and randomized 2:1. The primary endpoint will be all-cause mortality (ACM) at 4 weeks with a key secondary endpoint of ACM at 6 weeks. Achieving LUI approval is contingent upon successfully meeting both endpoints.

On October 2, 2017, Vical issued a press release regarding the eligibility of VL-2397 for LUI approval. A copy of the press release is attached at exhibit 99.1.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

99.1 Press release issued by Vical Incorporated on October 2, 2017.

Forward-Looking Statements.

This report contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include anticipated developments in clinical programs, including the plans, timing of initiation, and enrollment for clinical trials. Risks and uncertainties include whether Vical or others will continue development of VL-2397; 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 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; the fact that results from the planned Phase 2 clinical trial of VL-2397 may be inconsistent with the results from prior preclinical studies and clinical trials; whether Vical will have access to sufficient capital to fund its planned development activities; whether Vical 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 Vical's judgment as of the date of this report. Vical disclaims, however, any intent or obligation to update these forward-looking statements.

EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFilingEXHIBIT 99.1Vical Announces that its Antifungal VL-2397 is Eligible for Limited Use Indication Approval by FDA Based on a Single Phase 2 Efficacy Trial Vical plans to initiate Phase 2 trial of VL-2397 for the treatment of invasive aspergillosis in 4Q 2017 Management to host conference call on October 3rd at 12:00 pm ET to discuss the Phase 2 trial design SAN DIEGO,…
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Vical Incorporated researches and develops biopharmaceutical products based on its deoxyribonucleic acid (DNA) delivery technologies for the prevention and treatment of life-threatening diseases. The Company has approximately four active, independent, or partnered development programs in the areas of infectious disease including Phase III clinical trial of ASP0113 for prevention of cytomegalovirus (CMV) reactivation in stem cell transplant recipients and Phase II clinical trial of ASP0113 for prevention of CMV infection in kidney transplant recipients; Phase I/II clinical trial of its therapeutic genital herpes vaccine, designed to reduce viral shedding and genital herpes lesions in herpes simplex virus type 2 (HSV-2) infected patients; an ongoing Phase I program of VL-2397 for invasive fungal infections, and completed preclinical program, with an allowed investigational new drug application (IND) using its CyMVectin prophylactic vaccine formulated with its Vaxfectin adjuvant.

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