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): June 19, 2014
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 June 19, 2014, Provectus Biopharmaceuticals, Inc.
(the Company) issued a press release relating to the Companys previously announced conference call to be held on Thursday, June 19, 2014 to discuss the outline of the Companys proposed phase 3 study of the Companys
oncology drug candidate PV-10 in the treatment of melanoma as well as developments in the use of PV-10 in other cancer indications and to discuss the Companys dermatological drug candidate PH-10. A copy of the Companys press release is
attached hereto as Exhibit 99.1 and is incorporated herein by reference.
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 June 19, 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: June 19, 2014
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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 99.1
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Contact: |
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Provectus Biopharmaceuticals, Inc. Peter R.
Culpepper, CFO, COO Phone: 866-594-5999 #30 |
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Porter, LeVay & Rose, Inc. Marlon Nurse,
DM, SVP Investor Relations Phone: 212-564-4700 Bill
Gordon Media Relations Phone: 212-724-6312 |
PROVECTUS BIOPHARMACEUTICALS, INC. TO HOLD CONFERENCE CALL TODAY TO DETAIL OUTLINE OF PHASE 3 CLINICAL TRIAL
OF PV-10 IN MELANOMA TREATMENT
KNOXVILLE, TN, June 19, 2014 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT)
(http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, wishes to remind interested parties that it will hold a conference call today, Thursday, June 19, 2014 at 4:00 p.m. EDT.
Management will discuss the outline of the Companys planned phase 3 study of PV-10 in the treatment of melanoma and developments in the use of PV-10 in
other cancer indications including PV-10 in combination as appropriate. It will also review PV-10 data presented in Chicago at ASCO earlier in the month on June 2nd, as well as provide
updates on PH-10 and news regarding its use. Management will also discuss its potential plans to monetize its PV-10 and PH-10 assets with various contemplated license and co-development transactions.
The Company has submitted PV-10 phase 2 melanoma study results to www.clinicaltrials.gov and will announce when these are published and become publicly
available. In the interim, the Company is providing data presented at ASCO via this link: http://www.pvct.com/publications/ASCO-Poster-2014.pdf, which contains the phase 3 study outline that the Company will discuss on todays conference
call. Moffitt Cancer Center data presented at ASCO is expected to be published in a future peer-reviewed journal publication.
Those who wish to
participate in the conference call may telephone 877-407-4019 from the U.S. International callers may telephone 201-689-8337 approximately 15 minutes before the call. A webcast will also be available at www.pvct.com.
A digital replay will be available by telephone approximately two hours after the completion of the call until August 19, 2014, and may be accessed by
dialing 877-660-6853 from the U.S. or 201-612-7415 for International callers, and using the Conference ID#13584727.
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals 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 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 press 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, 2013, and in our
Quarterly Report on Form 10-Q for the quarter ended March 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 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; |
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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; |
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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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