Attached files
| file | filename |
|---|---|
| EX-99.1 - PRESS RELEASE - Brickell Biotech, Inc. | exh_991.htm |
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): June 11, 2018
VICAL INCORPORATED
(Exact Name of Registrant as Specified in Charter)
| DELAWARE | 000-21088 | 93-0948554 |
| (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 8.01. Other Events.
On June 11, 2018 Vical Incorporated issued a press release announcing top-line results from a randomized, double-blind, placebo-controlled, Phase 2 clinical study of its therapeutic bivalent vaccine candidate for herpes simplex virus type 2 (HSV-2), the leading cause of recurrent genital herpes. The study did not meet its primary endpoint of annualized lesion recurrence rate calculated based on those genital recurrences that were both clinically- and virologically-confirmed during a minimum of nine months of surveillance. The Phase 2 study was conducted in 261 healthy HSV-2 seropositive adults, 18 to 50 years of age, with a self-reported history of 4 to 9 recurrences per year. Subjects were randomized 2:1 to receive either vaccine or placebo. The vaccine was generally safe and well tolerated, as assessed by an independent safety monitoring board; there were no grade 4 adverse events or serious adverse events reported related to vaccination.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.Exhibit No. Description 99.1 Press release issued by Vical Incorporated on June 11, 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: June 11, 2018 | By: | /s/ ANTHONY A. RAMOS |
| Anthony A. Ramos | ||
| Chief Financial Officer | ||