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): April 30, 2015
PROVECTUS BIOPHARMACEUTICALS, INC.
(Exact name of registrant as specified in charter)
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Delaware |
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001-36457 |
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90-0031917 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
7327 Oak Ridge Hwy., Knoxville, Tennessee 37931
(Address of Principal Executive Offices)
(866) 594-5999
(Registrants 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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 April 30, 2015, Provectus Biopharmaceuticals, Inc.
(the Company) issued a press release (the Press Release) announcing that the European Society for Medical Oncology (ESMO) has accepted the Companys abstract, Phase 1 Study of PV-10 for Chemoablation of
Hepatocellular Cancer and Cancer Metastatic to the Liver, for poster presentation at the ESMO 17th World Congress on Gastrointestinal Cancer, which takes place July 1- 4, 2015 in Barcelona, Spain. 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.
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Exhibit Number |
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Description |
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99.1 |
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Press Release, dated April 30, 2015 |
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: April 30, 2015
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PROVECTUS BIOPHARMACEUTICALS, INC. |
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By: |
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/s/ Peter R. Culpepper |
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Peter R. Culpepper |
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Chief Financial Officer and Chief Operating Officer |
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EXHIBIT INDEX
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Exhibit Number |
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Description |
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99.1 |
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Press Release, dated April 30, 2015 |
Exhibit 99.1
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Contact: |
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Provectus Biopharmaceuticals, Inc. |
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Porter, LeVay & Rose, Inc. |
Peter R. Culpepper, CFO, COO |
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Marlon Nurse, DM, SVP Investor Relations |
Phone: 866-594-5999 #30 |
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Phone: 212-564-4700 |
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Bill Gordon Media Relations |
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Phone: 212-724-6312 |
FOR IMMEDIATE RELEASE
PROVECTUS BIOPHARMACEUTICALS ABSTRACT ON LIVER CANCER ACCEPTED FOR POSTER PRESENTATION AT EUROPEAN SOCIETY FOR MEDICAL ONCOLOGYS
17th WORLD CONGRESS ON GASTROINTESTINAL CANCER
Phase 1 Study Data to be
Presented in Barcelona During WGI 2015, July 1-4, 2015
KNOXVILLE, TN, April 30, 2015 Provectus Biopharmaceuticals, Inc. (NYSE
MKT: PVCT, http://www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company (Provectus or the Company), announced today that the European Society for Medical Oncology (ESMO) has accepted the
Companys abstract, Phase 1 Study of PV-10 for Chemoablation of Hepatocellular Cancer and Cancer Metastatic to the Liver, for poster presentation at the ESMO 17th World Congress on Gastrointestinal Cancer.
The conference runs July 1-4, 2015, and is being held at The International Convention Center of Barcelona, in Barcelona, Spain. The Company will post the
presentation on its website at www.pvct.com at the time of the presentation.
The abstract, number P-116, will be available online on June 24, 2015.
Provectus will provide more details about the presentation and conference as they become available.
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.
ESMOs mission is to advance cancer care and cure through
fostering and disseminating good science that leads to better medicine and determines best practice.
ESMOs 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 the ESMO World Congress on Gastrointestinal Cancer
The ESMO World Congress on Gastrointestinal Cancer is the premier global event in the field, encompassing malignancies affecting every component of the
gastrointestinal tract and aspects related to the care of patients with gastrointestinal cancer, including screening, diagnosis and the latest management options for common and uncommon tumors. It has been endorsed by leading professional societies
and organizations. For more information, visit http://www.esmo.org/Conferences/World-GI-2015-Gastrointestinal-Cancer
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 Companys other clinical trials, including its current phase 3
study in melanoma, can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Companys 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 managements current knowledge, assumptions, beliefs, estimates, and expectations and express managements 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, 2014) and the following:
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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); |
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our determination whether to license PV-10, our melanoma drug product candidate, 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; |
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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 |
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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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