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 12, 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
(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:
¨ | 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 12, 2016, Provectus Biopharmaceuticals, Inc. (the Company), issued a press release (the Press Release) announcing that the European Society for Medical Oncologys (ESMO) Scientific Committee has accepted an abstract for a poster presentation detailing the use of PV-10 as a treatment for stage III and IV melanoma as part of ESMOs 2016 Congress. 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 |
Description | |
99.1 | Press Release, dated July 12, 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 12, 2016
PROVECTUS BIOPHARMACEUTICALS, INC. | ||
By: | /s/ Peter R. Culpepper | |
Peter R. Culpepper | ||
Interim Chief Executive Officer and Chief Operating Officer |
3
EXHIBIT INDEX
Exhibit |
Description | |
99.1 | Press Release, dated July 12, 2016 |
Exhibit 99.1
Contact: | Porter, LeVay & Rose, Inc. | |
Provectus Biopharmaceuticals, Inc. | Marlon Nurse, DM, SVP Investor Relations | |
Peter R. Culpepper, Interim CEO, COO | Phone: 212-564-4700 | |
Phone: 866-594-5999 #30 | Allison + Partners | |
Todd Aydelotte, Managing Director | ||
Media Relations | ||
Phone: 646-428-0644 |
FOR IMMEDIATE RELEASE
PROVECTUS BIOPHARMACEUTICALS ANNOUNCES ACCEPTANCE OF ABSTRACT
FOR POSTER PRESENTATION AT EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY 2016 CONGRESS
Poster Titled Intralesional Rose Bengal for Stage III and IV Melanoma
Congress Scheduled to Run October 7-11, 2016, Copenhagen, Denmark
KNOXVILLE, TN, July 12, 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 the European Society for Medical Oncologys Scientific Committee has accepted an abstract for a poster presentation detailing the use of PV-10 as a treatment for stage III and IV melanoma as part of ESMOs 2016 Congress.
The exact date and time of the presentation, titled Intralesional rose bengal for stage III and IV melanoma, has yet to be decided. When the schedule is set, the details for this abstract, #3438, will be available at http://www.esmo.org/Conferences/ESMO-2016-Congress/Programme.
In addition, the abstract will also be published in the ESMO 2016 Congress Abstract Book, a supplement to the official ESMO journal, Annals of Oncology. ESMO has not yet announced the final publication number. The ESMO 2016 Congress will be held in Copenhagen, Denmark, from October 7-11, 2016.
About ESMO
ESMO is the leading professional organisation for medical oncology. With more than 13,000 members representing oncology professionals from over 130 countries, ESMO is the society of reference for oncology education and information. We are committed to supporting our members to develop and advance in a fast-evolving professional environment.
ESMOs educational resources support an integrated, multi-professional approach to cancer care. We have European roots and a global reach: we welcome oncology professionals from around the world and we seek to erase boundaries in cancer care as we pursue our mission across oncology, worldwide. For more information, visit: http://www.esmo.org/
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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 Companys other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Companys 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 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, 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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