0001193125-14-350625.txt : 20140924 0001193125-14-350625.hdr.sgml : 20140924 20140924060159 ACCESSION NUMBER: 0001193125-14-350625 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140924 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140924 DATE AS OF CHANGE: 20140924 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PROVECTUS BIOPHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0000315545 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 900031917 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36457 FILM NUMBER: 141117168 BUSINESS ADDRESS: STREET 1: 7327 OAK RIDGE HWY STREET 2: SUITE B CITY: KNOXVILLE STATE: TN ZIP: 37931 BUSINESS PHONE: 865-769-4011 MAIL ADDRESS: STREET 1: 7327 OAK RIDGE HWY STREET 2: SUITE B CITY: KNOXVILLE STATE: TN ZIP: 37931 FORMER COMPANY: FORMER CONFORMED NAME: PROVECTUS PHARMACEUTICALS INC DATE OF NAME CHANGE: 20020417 FORMER COMPANY: FORMER CONFORMED NAME: ZAMAGE DIGITAL IMAGING INC DATE OF NAME CHANGE: 20011126 FORMER COMPANY: FORMER CONFORMED NAME: SPM GROUP INC DATE OF NAME CHANGE: 19920703 8-K 1 d794122d8k.htm 8-K 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): September 24, 2014

 

 

PROVECTUS BIOPHARMACEUTICALS, INC.

(Exact name of registrant as specified in charter)

 

 

 

Delaware   001-36457   90-0031917

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

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 September 24, 2014, Provectus Biopharmaceuticals, Inc. (the “Company”), issued a press release (the “Press Release”), announcing that the abstract entitled “Subgroup efficacy in patients receiving intralesional rose bengal to all existing melanoma in phase II study PV-10-MM-02,” to be presented at the European Society for Medical Oncology 2014 Congress in Madrid, Spain, is now available at https://www.webges.com/cslide/library/esmo/browse/search/8ct#9faD03sJ. A copy of the Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Pursuant to the rules and regulations of the Securities and Exchange Commission, the information in this Item 7.01 disclosure, including Exhibit 99.1 and information set forth therein, is deemed to have been furnished and shall not be deemed to be “filed” under the Securities Exchange Act of 1934.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
Number

  

Description

99.1    Press Release, dated September 24, 2014


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: September 24, 2014

 

PROVECTUS BIOPHARMACEUTICALS, INC.
By:  

 /s/ Peter R. Culpepper

  Peter R. Culpepper
  Chief Financial Officer and Chief Operating Officer

 

2


EXHIBIT INDEX

 

Exhibit
Number

  

Description

99.1    Press Release, dated September 24, 2014
EX-99.1 2 d794122dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

 

Contact:     

Provectus Biopharmaceuticals, Inc.

Peter R. Culpepper, CFO, COO

Phone: 866-594-5999 #30

     Porter, LeVay & Rose, Inc.

Marlon Nurse, DM, SVP –Investor Relations

Phone: 212-564-4700

Bill Gordon – Media Relations

Phone: 212-724-6312

PROVECTUS BIOPHARMACEUTICALS’ PV-10 CLINICAL DATA ON MELANOMA NOW

AVAILABLE FOR EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY 2014 CONGRESS

Poster Presentation Scheduled for Sunday, September 28, 2014, From 12:45 To 1:45 pm

ESMO 2014 Congress in Madrid, Spain, Runs from September 26-30, 2014

KNOXVILLE, TN, September 24, 2014 — Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company (“Provectus”), announced today that the abstract entitled, “Subgroup efficacy in patients receiving intralesional rose bengal to all existing melanoma in phase II study PV-10-MM-02,” to be presented at the European Society for Medical Oncology 2014 Congress, is now available at https://www.webges.com/cslide/library/esmo/browse/search/8ct#9faD03sJ.

The ESMO 2014 Congress in Madrid, Spain, runs from September 26-30, 2014. This poster presentation will be held on Sunday, September 28, 2014, beginning at 12:45 pm local time, presented by Sanjiv S. Agarwala, MD, of St. Luke’s Hospital and Health Network, Bethlehem, PA.

Dr. Craig Dees, PhD, CEO of Provectus, said, “We are very pleased that these subgroup data will be presented at ESMO this year, and we are glad that our principal investigator Dr. Agarwala will be available to discuss this work with attendees.”

PV-10, a 10% solution of Rose Bengal that is currently being investigated as a potential cancer therapeutic, is designed for injection into solid tumors (intralesional administration).

About the European Society for Medical Oncology

The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care.

ESMO’s mission is to advance cancer care and cure through fostering and disseminating good science that leads to better medicine and determines best practice.

ESMO’s scientific journal, Annals of Oncology, ranks among the top clinical oncology journals worldwide. ESMO events are the meeting place in Europe for medical oncologists to update their knowledge, to network and to exchange ideas.


To find out more about ESMO, please visit: www.esmo.org

About Provectus Biopharmaceuticals, Inc.

Provectus Biopharmaceuticals, Inc., specializes in developing oncology and dermatology therapies. PV-10, its novel investigational drug for cancer, is designed for injection into solid tumors (intralesional administration), thereby reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. PH-10, its topical investigational drug for dermatology, is undergoing clinical testing for psoriasis and atopic dermatitis. Provectus has completed phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: This release contains “forward-looking statements” as defined under U.S. federal securities laws. These statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations and express management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements. Readers should not place undue reliance on forward-looking statements. Such statements are made as of the date hereof, and we undertake no obligation to update such statements after this date.

Risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements include those discussed in our filings with the Securities and Exchange Commission (including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2013, and in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2014, and June 30, 2014), and the following:

 

    our determination, based on guidance from the FDA, whether to proceed with or without a partner with a phase 3 trial of PV-10 to treat locally advanced cutaneous melanoma and the costs associated with such a trial if it is necessary;

 

    our determination whether to license PV-10, our melanoma drug product candidate, and other solid tumors such as liver cancer, if such licensure is appropriate considering the timing and structure of such a license, or to commercialize PV-10 on our own to treat melanoma and other solid tumors such as liver cancer;

 

    our ability to license our dermatology drug product candidate, PH-10, on the basis of our phase 2 atopic dermatitis and psoriasis results, which are in the process of being further developed in conjunction with mechanism of action studies; and

 

    our ability to raise additional capital if we determine to commercialize PV-10 and/or PH-10 on our own, although our expectation is to be acquired by a prospective pharmaceutical or biotech concern prior to commercialization.

###

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