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): March 12, 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 2.02.

Results of Operations and Financial Condition.

On March 12, 2015, Provectus Biopharmaceuticals, Inc. (the “Company”) issued a press release (the “Financial Results Press Release”) reporting its results of operations and financial condition for the quarter and year ended December 31, 2014. A copy of the Financial Results Press Release is attached hereto as Exhibit 99.1 and incorporated into this Item 2.02 by reference.

Pursuant to the rules and regulations of the Securities and Exchange Commission, the information in this Item 2.02 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 7.01.

Regulation FD Disclosure.

On March 12, 2015, the Company issued a press release (the “Phase 3 Press Release”) announcing that an amended phase 3 protocol for the testing of PV-10, the Company’s novel investigational drug for cancer, for the treatment of melanoma has been submitted to the U.S. Food and Drug Administration. A copy of the Phase 3 Press Release is attached hereto as Exhibit 99.2 and incorporated into this Item 7.01 by reference.

On March 12, 2015, the Company issued a press release (the “PH-10 Press Release”) announcing that it has received U.S. Patent No. 8,974,363 from the United States Patent and Trademark Office. The new patent, entitled “Topical medicaments and methods for photodynamic treatment of disease,” provides detailed protection of the Company’s investigational dermatological drug PH-10. A copy of the PH-10 Press Release is attached hereto as Exhibit 99.3 and incorporated into this Item 7.01 by reference.

Pursuant to the rules and regulations of the Securities and Exchange Commission, the information in this Item 7.01 disclosure, including Exhibit 99.2, Exhibit 99.3 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		Financial Results Press Release, dated March 12, 2015
99.2		Phase 3 Press Release, dated March 12, 2015
99.3		PH-10 Press Release, dated March 12, 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: March 12, 2015

 

 

2

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EXHIBIT INDEX

 

Exhibit Number		Description
99.1		Financial Results Press Release, dated March 12, 2015
99.2		Phase 3 Press Release, dated March 12, 2015
99.3		PH-10 Press Release, dated March 12, 2015

Exhibit 99.1

 

 

Contact: Provectus Biopharmaceuticals, Inc. Peter R. Culpepper, CFO, COO Phone: 866-594-5999 #30		Porter, LeVay & Rose, Inc. Marlon Nurse, DM, SVP – Investor Relations Phone: 212-564-4700 Bill Gordon – Media Relations Phone: 212-724-6312

FOR IMMEDIATE RELEASE

PROVECTUS BIOPHARMACEUTICALS, INC. REPORTS FOURTH QUARTER AND

YEAR END 2014 RESULTS

KNOXVILLE, TN, March 12, 2015 — Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company (“Provectus”), today announced its results of operations and financial condition for the fourth quarter and year ended December 31, 2014.

Provectus will also hold its year-end quarterly business update conference call at 4 p.m. (EST) today to provide a business update on PV-10 and PH-10 to the investment community and answer questions from investors.

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 Provectus’s website, www.pvct.com. A digital replay will be available by telephone approximately two hours after the completion of the call until March 31, 2015, 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# 13601930.

Fourth Quarter and Year End Results and Balance Sheet Highlights

At December 31, 2014, cash and cash equivalents were $17,391,601 compared to $15,696,243 at December 31, 2013. The increase of approximately $1.7 million was due primarily to an increase of sales of common stock and warrants as well as exercises of warrants and stock options, partially offset by approximately $4 million more cash that was used in operating activities.

Therefore, our ability to continue as a going concern is reasonably assured due to our cash and cash equivalents on hand at December 31, 2014. Given our current rate of expenditures and our ability to curtail or defer certain controllable expenditures, we do not anticipate needing to raise additional capital to further develop PV-10 on our own to treat locally advanced cutaneous melanoma, cancers of the liver, recurrent breast cancer, pancreatic cancer and other indications because we plan to strategically monetize PV-10 through appropriate regional license transactions, license PH-10 for psoriasis and other related indications described as inflammatory dermatoses, and also complete the spin-out of Pure-ific Corporation and the other non-core subsidiaries.

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Shareholders’ equity at December 31, 2014 was $26,184,158. This compares to shareholders’ equity at December 31, 2013 of $20,008,184.

For additional information regarding Provectus’s results of operations and financial condition for the fourth quarter and year ended December 31, 2014, please see Provectus’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2015.

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 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 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;

 

•

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. Peter R. Culpepper, CFO, COO Phone: 866-594-5999 #30		Porter, LeVay & Rose, Inc. Marlon Nurse, DM, SVP – Investor Relations Phone: 212-564-4700 Bill Gordon – Media Relations Phone: 212-724-6312

FOR IMMEDIATE RELEASE

PROVECTUS BIOPHARMACEUTICALS UPDATES MARKET ON BUSINESS DEVELOPMENTS

Amended Phase 3 Protocol Submitted to FDA

Enrollment Begun in PH-10 Mechanism of Action Study

Enrollment Completed in PV-10 Immunology Mechanism of Action Trial

KNOXVILLE, TN, March 12, 2015 — Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus”), today provides the market with a business update that addresses several matters.

The Company noted that an amended phase 3 protocol for the testing of PV-10, its novel investigational drug for cancer, for the treatment of melanoma has been submitted to the U.S. Food and Drug Administration (the “FDA”). There were a number of minor changes made to the protocol that the Company discussed in its press release of February 9, 2015, which addressed the FDA review. The Company does not require additional FDA review to start the phase 3 study, and has begun the process of gaining IRB approval for the amended protocol (https://clinicaltrials.gov/show/NCT02288897).

In addition, the Company’s study of PV-10 for liver tumors is continuing to accrue patients, in particular those with tumors metastatic to the liver (https://clinicaltrials.gov/show/NCT00986661). The Company expects to report initial data at one or more international cancer conferences this summer.

Also with regard to study enrollments, the Company announced that enrollment has begun in its mechanism of action [MOA] study for PH-10, its topical investigational drug for dermatology (https://clinicaltrials.gov/show/NCT02322086). The Company expects to recruit up to 30 patients at three study centers in the U.S. At the same time, Provectus announced the completion of enrollment in the PV-10 MOA study, meeting the target of enrolling 15 patients in the study (https://clinicaltrials.gov/show/NCT01760499). Enrollment and data collection for the PH-10 study are expected to be completed in December 2015. The Company expects further data from the PV-10 MOA study to be reported later this year or early in 2016.

The Company also noted that enrollment is continuing under its expanded access protocol for PV-10, with well over 100 melanoma patients having received PV-10 in the U.S. and Australia (https://clinicaltrials.gov/show/NCT01260779).

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The Company noted that the January 2015 allowance of its novel synthesis patent application by the Chinese Patent Office, following on the issuance of the parent case in the U.S. in September 2013, represents a continued expansion of its global patent strategy, in particular protecting the key component of both PV-10 and PH-10 in major markets. Such process patents serve to strengthen its product-specific patents, such as U.S. Patent No. 8,974,363 issued earlier this week covering PH-10.

Provectus will also hold its year-end quarterly business update conference call at 4 p.m. (EST) today to provide a detailed business update on PV-10 and PH-10 to the investment community and answer questions from investors.

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 Provectus’s website, www.pvct.com. A digital replay will be available by telephone approximately two hours after the completion of the call until March 31, 2015, 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# 13601930.

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 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);

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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;

 

•

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 99.3

 

 

Contact: Provectus Biopharmaceuticals, Inc. Peter R. Culpepper, CFO, COO Phone: 866-594-5999 #30		Porter, LeVay & Rose, Inc. Marlon Nurse, DM, SVP – Investor Relations Phone: 212-564-4700 Bill Gordon – Media Relations Phone: 212-724-6312

FOR IMMEDIATE RELEASE

PROVECTUS BIOPHARMACEUTICALS AWARDED PH-10 PATENT BY U.S. PATENT AND

TRADEMARK OFFICE

KNOXVILLE, TN, March 12, 2015 — Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company (“Provectus”), announced today that it has received U.S. Patent No. 8,974,363 from the United States Patent and Trademark Office (USPTO).

The new patent, entitled “Topical medicaments and methods for photodynamic treatment of disease,” provides detailed protection of the Company’s investigational dermatological drug PH-10.

Dr. Craig Dees, PhD, CEO of Provectus, said, “This is our 29th patent awarded in the United States, and it protects our PH-10 preparation of rose bengal in the treatment of a number of diseases, especially those affecting the skin but not limited to them. It also covers the use of PH-10 against diseases of the mouth and digestive tract, the urinary tract and reproductive system, the respiratory tract and all organs related to those. In addition, it protects the use of PH-10 in treating tissue surfaces exposed during surgery and tissue affected by microbial and parasitic infection. Delivery of PH-10 in liquid, semi-solid and aerosol forms are covered.”

He added, “We believe that PH-10 may have multiple medical uses. Much as our investigational agent PV-10 appears promising for melanoma, liver cancer, breast cancer and so on, PH-10 may prove itself useful in treating many different types of tissue disease, disorder and damage. Provectus is engaged in several research projects at differing stages of development to determine just how broad its applications may be.”

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 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.

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-more-

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 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;

 

•

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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