PVCT Provectus Biopharmaceuticals Inc (QB)

 

 

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 26, 2015

 

 

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))

 

 

 

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Item 7.01.

Regulation FD Disclosure.

On June 26, 2015, Provectus Biopharmaceuticals, Inc. (the “Company”) issued a press release (the “Munich Press Release”) announcing that Dr. Vernon Sondak (Moffitt Cancer Center, Tampa, Florida) presented data on “Intralesional Therapy for Melanoma with PV-10” during the 5th European Post-Chicago Melanoma/Skin Cancer Meeting in Munich, Germany. A copy of the Munich Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

On June 26, 2015, the Company issued a press release (the “AAPI Press Release”) announcing that the American Association of Physicians of Indian Origin (“AAPI”) honored the Company at a gala during the AAPI’s 33rd Annual Convention and Scientific Assembly on Friday, June 19, 2015, held at the Renaissance Hotel Convention Center in Orlando, Florida. A copy of the AAPI Press Release is attached hereto as Exhibit 99.2 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 Exhibits 99.1 and 99.2 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		Munich Press Release, dated June 26, 2015
99.2		AAPI Press Release, dated June 26, 2015

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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 26, 2015

 

 

2

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EXHIBIT INDEX

 

Exhibit Number		Description
99.1		Munich Press Release, dated June 26, 2015
99.2		AAPI Press Release, dated June 26, 2015

Exhibit 99.1

 

 

Contact:
Provectus Biopharmaceuticals, Inc.		Porter, LeVay & Rose, Inc.
Peter R. Culpepper, CFO, COO		Marlon Nurse, DM, SVP – Investor Relations
Phone: 866-594-5999 #30		Phone: 212-564-4700
		Todd Aydelotte – Media Relations
		Phone: 646-428-0644

FOR IMMEDIATE RELEASE            

PROVECTUS BIOPHARMACEUTICALS’ DATA ON PV-10 AS TREATMENT FOR MELONOMA PRESENTED AT 5TH EUROPEAN POST-CHICAGO MELANOMA / SKIN CANCER MEETING

Moffitt Cancer Center’s Dr. Vernon Sondak Addressed Meeting in Munich, Germany

KNOXVILLE, TN, June 26, 2015 — Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus” or the “Company”), today announced that Dr. Vernon Sondak (Moffitt Cancer Center, Tampa, FL, USA) presented data on “Intralesional Therapy for Melanoma with PV-10” during the 5th European Post-Chicago Melanoma/Skin Cancer Meeting in Munich, Germany.

Dr. Sondak spoke during “Symposium III – New Drugs and Trials I: Immunotherapy,” held Thursday, June 25. His conclusions included that “among the many agents currently being evaluated for use as intralesional therapy for melanoma, PV-10 possesses favorable safety and handling properties and induces rapid ablation of injected lesions to a degree similar to or possibly better than other agents,” and “preclinical and clinical data suggest PV-10 would be a good candidate to evaluate in conjunction with available systemic immunotherapies.”

The complete presentation is available at http://www.pvct.com/publications/Post-Chicago-Munich-Sondak-2015.pdf.

In addition, the poster titled “Trials in Progress: Intralesional Rose Bengal vs Systemic Chemotherapy for Treatment of Locally Advanced Cutaneous Melanoma,” which details the Company’s phase 3 clinical trial that began recently, was also presented at the meeting. For the poster, visit http://pvct.com/publications/Post-Chicago-Munich-2015.pdf.

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

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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, 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 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, 2014) 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 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;

 

•

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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Exhibit 99.2

 

 

Contact:
Provectus Biopharmaceuticals, Inc.		Porter, LeVay & Rose, Inc.
Peter R. Culpepper, CFO, COO		Marlon Nurse, DM, SVP – Investor Relations
Phone: 866-594-5999 #30		Phone: 212-564-4700
		Todd Aydelotte – Media Relations
		Phone: 646-428-0644

FOR IMMEDIATE RELEASE            

AAPI Honors Provectus Biopharmaceuticals During 33rd Annual Convention and Scientific Assembly

Provectus Recognized as a Pioneer to the AAPI - Global Clinical Research and Trial Network

Orlando, FL: June 26, 2015: The American Association of Physicians of Indian Origin (“AAPI”) honored Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus” or the “Company”), at a gala during the AAPI’s 33rd Annual Convention and Scientific Assembly on Friday, June 19, 2015. The annual convention, held at the Renaissance Hotel Convention Center, Orlando, FL from Wednesday, June 17 to Sunday, June 21, 2015, was attended by nearly 2,500 physicians of Indian origin and their families.

Provectus was recognized by AAPI, the largest ethnic medical association of physicians in the United States, for helping to develop AAPI’s Global Clinical Research and Trial Network. This network focuses on patient recruitment and clinical research.

Dr. Seema Jain, President of AAPI, praised the pioneering initiatives of Provectus in AAPI’s clinical trial and research program, and she expressed deep appreciation for sponsoring the activities of AAPI this year. She recalled of the Company’s participation and support for AAPI, which began with AAPI’s 2015 Global Healthcare Summit in Mumbai, India, January 2-4, 2015.

Dr. Ravi Jahagirdar, MD, the immediate Past President of AAPI, said, “AAPI welcomes the support of Provectus Biopharmaceuticals as we pursue our goals. The Company’s pioneering work in our Global Clinical Research and Trial Network has set a standard for other firms, and we are look forward to developing this network with the continued assistance of Provectus.”

Peter Culpepper, CFO and COO, of Provectus said, “Provectus is very proud of the honor AAPI has given us in recognition of our work with the organization. AAPI represents a key group within the American healthcare system. One in every seven American patients is seen by an Indian doctor, and this ratio is even higher in the smaller towns and underserved areas due to the larger proportion of Indian doctors in more remote locations.”

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“In addition, these physicians have close ties through family and friends to every segment of Indian society, a nation of one billion people, and they are especially well-placed to work with officials in India’s healthcare system and government. Our work with AAPI is mutually beneficial, and Provectus looks forward to deepening and broadening our relationship in the coming months and years.”

Delegates of AAPI represent nearly 100,000 Physicians, Fellows, and Residents in the United States. At the annual conference, AAPI provided an enriching platform for members comprised of medical, mental health, and dental physicians in American to engage with the latest in medical technology, research and advances in the world of all types of medicine and dental care. The convention included CME and DME accredited courses as well as variety of panel discussions, presentations and a research competition.

There were forums for AAPI Young Physicians Group (AAPI YPS) and for AAPI MSRF for medical students, residents and fellows. A nearly sold out Exhibitor Hall included medical and pharmaceutical products, jewelry, fashion designs, devices and equipment and medical and dental, practice-related services.

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, 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 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.

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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:

 

•

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 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;

 

•

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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