0001193125-16-647565.txt : 20160714 0001193125-16-647565.hdr.sgml : 20160714 20160714060157 ACCESSION NUMBER: 0001193125-16-647565 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160714 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160714 DATE AS OF CHANGE: 20160714 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: 161766480 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 d213712d8k.htm FORM 8-K Form 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): July 14, 2016

 

 

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 July 14, 2016, Provectus Biopharmaceuticals, Inc. (the “Company”), issued a press release (the “Press Release”) announcing that it has formed an Australian subsidiary, Provectus Biopharmaceuticals Australia Pty Ltd., and will open an office in Sydney, New South Wales, Australia. 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 July 14, 2016


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: July 14, 2016

 

PROVECTUS BIOPHARMACEUTICALS, INC.
By:   /s/ Peter R. Culpepper
 

Peter R. Culpepper

Interim Chief Executive Officer and Chief

Operating Officer

 

2


EXHIBIT INDEX

 

Exhibit
Number

  

Description

99.1    Press Release, dated July 14, 2016
EX-99.1 2 d213712dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

 

Contact:

Provectus Biopharmaceuticals, Inc.

Peter R. Culpepper, Interim CEO, COO

Phone: 866-594-5999 #30

   

Porter, LeVay & Rose, Inc.

Marlon Nurse, DM, SVP – Investor Relations

Phone: 212-564-4700

Allison + Partners Todd Aydelotte, Managing Director –

Media Relations

Phone: 646-428-0644

FOR IMMEDIATE RELEASE

PROVECTUS BIOPHARMACEUTICALS ESTABLISHES AUSTRALIAN SUBSIDIARY

Corporate Structure Better Reflects International Research Efforts

KNOXVILLE, TN, July 14, 2016 — Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus” or “The Company”), today announced that it has formed an Australian subsidiary, Provectus Biopharmaceuticals Australia Pty Ltd. In addition, the Company is opening a Sydney office in New South Wales.

Peter Culpepper, Interim CEO, stated, “The creation of an Australian entity is a fundamental part of our plans for extended global reach in conjunction with planned partnering for commercialization of PV-10.”

He noted, “Provectus has already been very active in Australia for years because of our research into PV-10 as an investigational treatment for melanoma. In fact, we began our phase 1 study of PV-10 in 2005 at the Sydney Melanoma Unit in North Sydney and the Newcastle Melanoma Unit in Waratah, both in New South Wales. Since then, we have also worked with the Princess Alexandra Hospital in Brisbane, Queensland, the Royal Adelaide Hospital in Adelaide, South Australia, and the Peter MacCallum Cancer Centre in Melbourne, Victoria.”

Culpepper concluded, “With a subsidiary in Australia, we are bringing our corporate structure in line with our scientific work. Our research and development program has been international from the very beginning, and now, Provectus is an international company. The new unit should make it easier to work with the Australian regulatory authorities, and having an office in the region may facilitate our work in Asian markets as Sydney is just two hours ahead of Beijing, Hong Kong and Singapore. If and when PV-10 receives approval in Australia and other nations in the region, we will have pre-positioned ourselves to develop a sales and marketing force.”

-more-


About Provectus Biopharmaceuticals, Inc.

Provectus Biopharmaceuticals is investigating new therapies for the treatment of skin cancer, liver cancer and breast cancer. Provectus’ investigational oncology drug, PV-10, is an ablative immunotherapy under investigation in solid tumor cancers. 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.provectusbio.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, 2015) and the following:

 

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

 

    our determination whether to license PV-10, our investigational drug product for melanoma and other solid tumors such as cancers of the liver, 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 cancers of the liver;

 

    our ability to license PH-10, our investigational drug product for dermatology, 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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