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): November 6, 2014

 

 

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 November 6, 2014, Provectus Biopharmaceuticals, Inc. (the “Company”), issued a press release (the “FDA Press Release”) announcing that the Company has submitted its phase 3 protocol for evaluation of PV-10 for treatment of locally advanced cutaneous melanoma to the Food and Drug Administration (the “FDA”). The FDA is expected to review the submission and comment on the proposed study population, clinical endpoints, and statistical analyses within 30 to 45 days. A copy of the FDA Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

On November 6, 2014, the Company issued a press release (the “Earnings Report Press Release”) announcing the Company’s financial results for the third quarter of 2014, including certain balance sheet highlights. A copy of the Earnings Report 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 Exhibit 99.1, Exhibit 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		FDA Press Release, dated November 6, 2014
99.2		Earnings Report Press Release, dated November 6, 2014

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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: November 6, 2014

 

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EXHIBIT INDEX

 

Exhibit Number		Description
99.1		FDA Press Release, dated November 6, 2014
99.2		Earnings Report Press Release, dated November 6, 2014

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
		Bill Gordon – Media Relations
		Phone: 212-724-6312
		FOR IMMEDIATE RELEASE

PROVECTUS BIOPHARMACEUTICALS SUBMITS PV-10 PHASE 3 MELANOMA PROTOCOL TO FDA

KNOXVILLE, TN, November 6, 2014— Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has submitted its phase 3 protocol for evaluation of PV-10 for treatment of locally advanced cutaneous melanoma to the FDA. The FDA is expected to review the submission and comment on the proposed study population, clinical endpoints, and statistical analyses within 30 to 45 days. Provectus believes details of the protocol will be available publicly on www.clinicaltrials.gov within the next few days.

The submission of the protocol follows completion of the due diligence audit of Provectus’ regulatory documents for PV-10 and PH-10. The purpose of the audit was to ensure that all the regulatory documents were in order.

Provectus anticipates few, if any, significant issues to arise from review of the protocol based on the substantive contact it has had with the FDA since the Company had its Type C meeting with the Agency on December 16, 2013. In particular in its letter of May 16, 2014 to the Company, the FDA gave guidance on assessment methods and endpoints that Provectus has incorporated into its phase 3 submission.

Shareholders received a letter from the CEO dated July 8, 2014 that detailed these interactions with the FDA. The letter read in part, “The primary endpoint of the study is progression-free survival (PFS) assessed using standard RECIST 1.1 criteria. Secondary endpoints are complete response rate and overall survival. Progression-free survival and overall survival are standard endpoints for oncology approvals. With these assessment methods and endpoints we’re following what the FDA has suggested to document the clinical benefit to patients after intralesional injection. And, we’ll measure patient reported outcomes to better characterize the relationship between complete response and symptoms of locally advanced cutaneous melanoma, such as pain and bleeding.”

 

-more-

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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, 2013, and in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2014, June 30, 2014 and September 30, 2014), and the following:

 

•

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;

 

•

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, INC. REPORTS THIRD QUARTER RESULTS

KNOXVILLE, TN, November 6, 2014 — Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company (“Provectus”), today announced financial results for the third quarter of 2014.

Third Quarter Results and Balance Sheet Highlights

At September 30, 2014, cash and cash equivalents were $17,773,680 compared to $15,696,243 at December 31, 2013. The increase of approximately $2.1 million was due primarily to $4.3 million cash received from warrant and stock option exercises and $7.5 million net proceeds from the sale of our common stock in the nine months ended September 30, 2014, offset by $9.7 million of operating cash expenses.

Therefore, our ability to continue as a going concern is reasonably assured due to our cash and cash equivalents on hand at September 30, 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, co-development partnerships, and license PH-10 for psoriasis and other related indications described as inflammatory dermatoses.

Shareholders’ equity at September 30, 2014 was $19,539,425. This compares to shareholders’ equity at December 31, 2013 of $6,628,666.

PROVECTUS BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

		September 30, 2014 (Unaudited)				December 31, 2013 (Audited)
Assets
Current Assets
Cash and cash equivalents		$	17,773,680			$	15,696,243
Total Current Assets			17,773,680				15,696,243
Equipment and furnishings, less accumulated depreciation of $434,479 and $429,331, respectively			95,555				30,113
Patents, net of amortization of $7,963,957 and $7,460,617, respectively			3,751,488				4,254,828
Other assets			27,000				27,000
		$	21,647,723			$	20,008,184
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable — trade		$	478,200			$	348,869
Accrued consulting expense			91,282				61,282
Other accrued expenses			311,579				102,795
Total Current Liabilities			881,061				512,946
Warrant liability			1,227,237				12,866,572
Total Liabilities			2,108,298				13,379,518
Stockholders’ Equity
Preferred stock; par value $.001 per share; 25,000,000 shares authorized; Series A 8% convertible preferred stock, 0 and 33,334 shares issued and outstanding, respectively, liquidation preference $0.75 (for 2013 in aggregate $25,001)			—				33
Common stock; par value $.001 per share; 300,000,000 authorized; 180,299,739 and 159,751,724 shares issued and outstanding, respectively			180,300				159,752
Paid-in capital			176,469,175				152,519,701
Accumulated deficit			(157,110,050	)			(146,050,820	)
Total Stockholders’ Equity			19,539,425				6,628,666
		$	21,647,723			$	20,008,184

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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, 2013, and in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2014, June 30, 2014, and September 30, 2014), and the following:

---

•

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;

 

•

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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