July 3, 2012

It's halftime at Provectus. The company's second half is about to begin.

This ad was first shown during the televised 2012 Superbowl. I'm going to borrow from it gratuitously for this post.

It's halftime at Provectus. The company's second half is about to begin. All that matters now is looking ahead and finding a way forward. Management is in their locker room discussing what they can do to win this game in the second half. Shareholders are hurting. And they're all wondering what management is going to do to make a comeback. They're all scared, because this isn't a game.

Monthly volume grinds lower and lower.

Quarterly volume paints an even more pathetic picture.

To add insult to injury, short interest, a mostly useless statistic at this point, creeps higher.

And the stock price has been cut in half over five years.

Despite a bleak stock picture, there became something very real, very palpable, about Rose Bengal, PV-10 and Provectus in 2012's first half:
  • On January 18, the FDA indicated an additional end-of-Phase 2 meeting with Provectus was not required, allowing the company to submit a design for a Special Protocol Assessment.
  • On March 19, Provectus released top line Phase 2 data for PH-10's first randomized controlled psoriasis study, corroborating the drug's effectiveness in mild-to-moderate plaque psoriasis.
  • On March 26, H. Lee Moffitt Cancer Center & Research Institute confirmed PV-10 chemoablation of melanoma lesions leads to a systemic response and the induction of systemic anti-tumor immunity, finding higher levels of interferon-γ, which is thought to be the quintessential cytokine mediating an immune response to melanoma.
  • On April 13, MD Anderson Cancer Center's Dr. Merrick Ross updates HemOnc Today Conference attendees about intralesional ablative therapies and PV-10. What has been said in private for months and months now is said more and more in public: PV-10 should be approved as a first-line therapy now.
  • On May 14, Provectus forms an independent board of directors with the addition of Jan Koe and the stepping down of the company's Dr. Eric Wachter. Earlier, in April, the NASDAQ formally lowers the requirements for stocks like PVCT to list on its exchange. In Provectus' case, a greater-than-$2-bid for 5 consecutive days only is needed.
  • On May 30, the company adds Doug Ulman, national cancer survivorship advocate and president and CEO of LIVESTRONG, to its corporate advisory board.
  • On June 22, Provectus releases top-line final data from its phase 2 clinical trial of PV-10 for metastatic melanoma. Dr. Agarwala's presentation also reveals overall disease burden is reduced, PV-10's response is durable, and the FDA is helping to get the drug approved with an easily beatable hurdle for PV-10 in the Phase 3 trial.
  • On June 26, an article in Cancer Watch highlighted Moffitt Cancer Center's studies confirming the direct effects of PV-10 chemoablation as well as its systemic response, and including powerful statements from key opinion leaders: PV-10 generates the quintessential immune response for melanoma, PV-10's induced antigen response is a surgical strike, there is no question there is a clinical need for PV-10, and the father of intralesional therapy acknowledging PV-10's promise.
  • On June 29, Provectus files a mixed securities shelf of both common and preferred stock, potentially setting the stage for a strategic minority investment by a bug pharmaceutical company.
All that matters now is what's ahead. How does management come from behind? How do shareholders win?
  • The SPA
  • A geographic-specific, indication-specific deal (or two)
  • A strategic minority investment, or perhaps a larger deal of some sort including the sale of Provectus shares to a corporate
  • A dermatology deal
  • More Moffitt murine study results
  • Moffitt human study results
  • Commencement of the MM Phase 3 trial
  • Progress towards accelerated approval
  • More intellectual property
  • A NASDAQ listing
Yeah, it's halftime shareholders. And, Provectus' second half is about to begin.

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