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): May 21, 2014
PROVECTUS BIOPHARMACEUTICALS, INC.
(Exact name of registrant as specified in charter)
| Delaware | 001-36457 | 90-0031917 | ||
| (State or other jurisdiction | (Commission | (IRS Employer | ||
| of incorporation) | File Number) | Identification No.) |
7327 Oak Ridge Hwy., Knoxville, Tennessee 37931
(Address of Principal Executive Offices)
(866) 594-5999
(Registrant’s Telephone Number, Including Area Code)
(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)) |
| Item 7.01. | Regulation FD Disclosure. |
On the afternoon of May 21, 2014, Provectus Biopharmaceuticals, Inc. (the “Company”) received a notice from the Food and Drug Administration (the “FDA”) denying the Company’s request for designation of the Company’s oncology drug, PV-10, as a Breakthrough Therapy treatment. On May 23, 2014, the Company issued a press release announcing the FDA’s denial. A copy of the Company’s press release, attached hereto as Exhibit 99.1, and the FDA’s letter denying Breakthrough Therapy designation, attached hereto as Exhibit 99.2, are incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit |
Description | |
| 99.1 | Press Release, dated May 23, 2014 | |
| 99.2 | FDA notice, dated May 16, 2014* | |
| * | Confidential treatment has been requested for portions of Exhibit 99.2. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of Exhibit 99.2 has been filed separately with the Securities and Exchange Commission. |
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.
Date: May 23, 2014
| PROVECTUS BIOPHARMACEUTICALS, INC. | ||
| By: | /s/ Peter R. Culpepper | |
| Peter R. Culpepper Chief Financial Officer and Chief Operating Officer | ||
2
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press release, dated May 23, 2014 | |
| 99.2 | FDA notice, dated May 16, 2014 | |