With or without a partner

Provectus held its 1Q15 conference call on Thursday, May 7th. A surprisingly poor quality transcript from Seeking Alpha is here. Details for hearing a replay of the conference may be found here.

Three times on the conference call the company’s CTO Dr. Eric Wachter, Ph.D. said — uncharacteristically, in my view — that Provectus was in a position to move ahead on two different aspect or thrusts of its clinical development program (melanoma combination therapy, liver in China [Asia]) with or without a larger pharmaceutical partner, which ultimately might or would market the drug combination or drug under its respective purview.

I found it odd and not the least bit striking that Eric would voice the notion of with or without a partner, which I would have expected Provectus CFO/COO Peter Culpepper to primarily convey because it "falls" under business and corporate development.

First, Eric said, in regards to a melanoma combination therapy Phase 1b/2 trial of PV-10 and an immune checkpoint inhibitor, “Since the checkpoint inhibitor we expect to use is licensed in the U.S., we can commence this study with or without the systems or a partner.” 

Peter previously intimated Eric's "the checkpoint inhibitor we expect to use" is Merck & Co.'s pembrolizumab (Keytruda). See Conference Call (May 9, 2015) on the blog's News page. Success in combination with one immune checkpoint inhibitor, PD-1 or PD-L1, should mean success with all or any of them. The "partner" can be any Big Pharma with an anti-PD-1 or -PD-L1 agent.

Second, Eric said, in regards to a China-focused hepatocellular Phase 1b/2 trial of PV-10 plus standard of care,  “Moving forward on the regulatory side now will allow us to move forward in Asia with or without the assistance of the corporate partner.” 

Third, he repeated himself on this topic, saying “So we're doing an appropriate thing right now which is moving forward in a position that will allows us to get into China with or without a partner in China.”

Here, the "partner" is Sinopharm, which Provectus originally entered into a memorandum of understanding ("MOU") with in August 2014, and later extended it (in November) to May 16, 2015.

Provectus struggled for nearly 5 years, from 2009-2010 to 2014-2015, to gain regulatory clarity of PV-10's initial pathway to approval, which of course is the monotherapeutic use of PV-10 for the treatment of unresectable locally advanced cutaneous melanoma.

Thinking more about Eric's comments, I don't believe of course he coming at the partner phrase from a business perspective (although I believe he now more fully understands the intertwining of his world [clinical development] and Peter's [business and corporate development]). I think he's speaking in the context of regulatory clarity. That is, Provectus can gain regulatory clarity with the FDA and sFDA/cFDA for the pathways to approval of melanoma combination therapy and liver in China, respectively, with or without a partner.