January 10, 2014

Disfigurement, Discomfort, Death

+273% 1-year stock performance, January 7, 2013 to January 7, 2014, no insider sales

+135% 1-month (roughly) performance, December 9, 2013 to January 7, 2014, no insider sales

-3% 1-week performance, December 31, 2013 to January 7, 2014, no insider sales

There are no sale-related Form 4 filings on the SEC website for Provectus filings through Tuesday, January 7th. For the previously provided link, check the “include” circle under “Ownership?” to bring up stock ownership-related filings. Another way is here, where I searched for filings using "4." I note Tuesday because filings must be made within two business days. It is theoretically possible management sold shares Wednesday or Thursday, with reporting of these transactions made via filings Friday and Monday, respectively. While I cannot write with certainty management have not sold shares, I’m going to go out on a limb and suggest they have not.

Historically, there have been no insider sales by Provectus officers and directors.* There only have been purchases.

You may recall Provectus' stock’s value proposition from my September 22nd investment letter (the closing share price: “The Company’s stock value proposition is very compelling at the current share price. Provectus appears close to achieving regulatory clarity for its lead indication, appears close to consummating regional license transactions for PV-10 in China and India, appears to have as least the interest of Pfizer as well as the attention of other global pharmaceutical companies, has no historical insider selling and plenty of historical insider buying, and has low institutional ownership. The Company, on the other hand, has a stock that until this year was mired in a multi-year downward trend, a capital structure that historically has weighed on the share price, trades on a minor U.S. stock exchange, is led by first-time public company leadership with no prior experience bringing an oncology drug to market and of which Wall Street is very skeptical, and has no institutional or Wall Street sponsor (the lack of playing Wall Street’s game in a highly regulated and capital-intensive industry like biotechnology, together with some shortcomings, has restrained the share price heretofore).”

Buy/sell transactions by directors/ex-directors (chronologically, I believe, Fuchs, McMasters, Koe and Smith) provide information and sometimes knowledge. I believe I am correct in writing only Koe purchased stock as a director (part of the September announced private placements), already having considerable ownership prior to his election as a member of Provectus' board of directors. Fuchs’ ownership, I believe, derived from his early funding involvement with the company, with warrants and possibly stock that also may have come with it. All directors have been awarded stock options over time for their roles.

* With Fuchs' departure from the board in July 2011, thus becoming an ex-director, he may have sold some or all of his shares thereafter.

A tweet from Thursday
I’m more interested, however, in management transactions. More specifically, and more to the point, there have been no sales ever by Craig Dees, Tim Scott, Eric Wachter and Peter Culepper.

Management has told us they await FDA guidance, per their December 18th Provectus Type C Meeting With FDAOncology Division Held December 16, 2013 press release. Presume management knew what went on in the meeting by being and participating in the meeting. Then:
  • If the meeting went “bad,” would they not have sold shares by now? By not selling, are they, along with shareholders, planning to go down with the ship and stock? That's, um, noble...
  • If the meeting (and, potentially, any follow-up**), however, was good or great, would it not make sense to continue to own stock, given now their view into FDA guidance that also might inform their view of PV-10's commercialization timeline. The founding principals and principal no. 4 are playing for tens and tens and tens and … of dollars, having historically eschewed a Wall Street or investment sponsor, and desirous of leading and controlling the company and the solving of a problem of global importance. Management is not playing for tens and tens of cents.
** It's clear from the thousands of pages of administrative and correspondence documents readily available on the Internet for drug approvals that sponsors (applicants) and the FDA routinely and regularly communicate and interact through the drug approval process.

From my investment letter: "PV-10, a novel oncology compound being developed by Knoxville, Tennessee-based Provectus Biopharmaceuticals, Inc., exemplifies innovation over incrementalism, meaningful over marginal, productized technology over hypothetical, and changing the world over accepting the status quo, with not an insignificant amount of serendipity over contrivance. In sum, these form the quintessential essence of a paradigm shift in the treatment of cancer.

This is where my investment thesis begins and ends: a novel drug compound with a pristine safety profile, a treatment well tolerated by and easily administered to patients, a ready made product inexpensively produced at scale, and a vast addressable market of unmet need that should be fully and very profitably met over time." Bold emphasis is mine. No one can call PV-10 a cure (or the Holy Grail), for now. I focus on the drug's ability, it's vast potential, to shift how doctors think about and subsequently act on treating cancer once found.

Cancer causes disfigurement through surgery, often the first solution considered by physicians (for those patients where surgery is a viable option) for many solid tumor cancers once discovered and diagnosed. PV-10’s tissue sparing ability, together with its safety and efficacy, eventually should eliminate the consideration of surgery first.

Cancer causes discomfort of varying degrees, typically adverse to toxic, when chemotherapy, radiotherapy, and many immunotherapies with actual or likely black box warnings or detrimental short- and long-term effects are used. PV-10’s 30-minute “half-life” means the drug is in the patient’s bloodstream for 30 minutes before it is excreted in the bile. Much more effective than other therapies, PV-10’s pristine safety profile and paucity of side effects eventually should eliminate the need for considering chemotherapy, radiotherapy or immunotherapy before first using PV-10.

Cancer causes death, often because the patient’s tumor burden is too great for the immune system to effectively fight back. Cancer wins because it’s discovered too late. It wins because the immune system is overwhelmed by toxic therapies like chemotherapy, radiotherapy and many immunotherapies, rendering it unable to effectively fight back. Can PV-10 mitigate or eliminate death caused by cancer? Time, more study and research, etc. only will tell. In the case of heavily diseased or tumor burdened patients, PV-10 eventually might be injected into as many accessible tumors as possible with the drug, increasing the likelihood of as many antigens as possible being presented to T cells and other immune system components for the immune system to eradicate as many or all vestiges of cancer from the body. For those previously with no hope, patients with very heavily diseased burden and severely compromised immune systems, PV-10 still could be used in combination (to be further examined, strategized, optimized and ultimately decided) with other systemic therapies like chemotherapy, radiotherapy and other immunotherapies to reduce tumor burden sufficiently for PV-10 to then help stimulate the immune system to finish off the cancer.

A paradigm shift in the treatment of cancer

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