Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT) (“Provectus” or the
“Company”) announced today that the Audit Committee of its Board of
Directors (the “Committee”) has conducted an internal investigation that
was initiated by the Committee in connection with the February 2016
resignation of the Company’s former chief executive officer, Dr. H.
Craig Dees. The Committee retained independent counsel and an advisory
firm with forensic accounting expertise to assist the Committee in
conducting the investigation. As part of the investigation, the
Committee reviewed the Company’s financial policies and procedures,
including management expenses.
Findings and conclusions of the Committee included:
Dr. Dees did not produce receipts for most of the travel expense
advances he received, and some receipts produced by Dr. Dees appear to
have been altered. Documentation of Dr. Dees' travel related expenses,
in general, have not been sufficient to prevent abuse, misconduct, the
appearance thereof, or may not satisfy IRS requirements.
Chairman Alfred E. Smith, IV said, “While these changes are undesirable
and some of the findings of the Committee certainly are disappointing,
the Company remains optimistic about the progress being made toward the
approval of drugs that offer so much hope to cancer victims. The
Company’s work on that front continues unabated and undeterred.”
Based on the Committee’s findings and conclusions, the Committee has
made the following recommendations to the Board of Directors, all for
immediate action:
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1)
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Appointment of an outside compliance consultant;
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2)
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That the highest priority be placed on identifying and recruiting a
permanent CEO and any other positions necessary;
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3)
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That a demand be made to Dr. Dees for reimbursement of any monies
advanced to him (if unsubstantiated), and, if so, those monies
voluntarily be reimbursed or recovered by legal action if necessary;
and
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4)
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The Committee and counsel make decisions in terms of referral of
any of these matters to regulatory authorities.
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The Committee also emphasized the necessity that the Company put in
place more clearly defined, tighter controls, including a clear process
for limiting, approving and documenting advances and expenses and
appropriately managing them.
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:
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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 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;
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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
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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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