I recently conducted an email interview with Chief Operations Officer, Peter Culpepper of Provectus Pharmaceuticals (NYSEMKT:PVCT). The company operates within the biopharmaceutical industry, has roughly a $162 million market cap and is listed on the NYSE MKT. Following are excerpts from the interview:
I first want to discuss the denial of Breakthrough Therapy Designation for PV-10 for melanoma, which, of course, was not a favorable outcome. Could you briefly highlight the consequences of this decision?
It turns out that the BTD denial has been very positive for PV-10 development, because it enables us to forge an acceptable path forward with PV-10 in an appropriate phase 3. We now have, thanks to the FDA comments in the BTD denial letter, an appropriate patient population for PV-10, and a much better understanding of the appropriate endpoints and standard of care comparator.
What is the anticipated market trajectory for PV-10?
We anticipate PV-10 phase 3 for melanoma to be one path for PV-10 approval. We anticipate also combining PV-10 to treat patients with disease inaccessible to direct injections. We also anticipate treating primary liver cancer patients in an upcoming randomized phase 2 study and seeking an expedited approval path in that important indication as well.
On Monday, Provectus announced a Memorandum of Understanding with Sinopharm for PV-10, but little of the event was actually disclosed. First, could you please provide some insight on this event, and second, when can investors expect additional or full disclosure of a possible licensing agreement?
The MOU, as referenced in the press release, states that "the parties agreed that PV-10 is an advanced innovative drug representing the oncology research trend worldwide, [which] will provide extensive economic and social benefits to [the Chinese] market." This means that PV-10 is an important investigational drug for the benefit of patients in China. We expect additional disclosure as appropriate within the 90 day period specified in the press release.
Is Provectus currently looking to expand the use of PV-10 across other indications, or is the focus solely on melanoma, cancers of the liver and skin conditions?
We are also interested in PV-10 to treat other solid tumors, including breast cancer, lung cancer, pancreatic cancer, prostate cancer and kidney cancer, which all happened to be mentioned in the Sinopharm referenced press release this week.
What possible synergies do you foresee for PV-10?
Melanoma can spread to the liver and it makes sense to the existing melanoma oncologists familiar with using PV-10 to treat melanoma and to also treat any cancer (melanoma or otherwise) that has spread or originated within the liver. FDA DOP2 also oversees both melanoma and liver cancer indications so there is regulatory oversight potential synergy as well.
Why was OS selected as a secondary endpoint for the Phase 3 trial of PV-10 in melanoma? Also, in the event that PV-10 yields a statistically significant PFS benefit, but not a statistically significant OS benefit, does the product lose its market potential?
It is viewed as appropriate secondary endpoint for the patient population to be treated in the phase 3. Most likely not because concurrent with the phase 3 melanoma study is interest in combining PV-10 with checkpoint protein inhibitors to treat patients with stage 4 (versus stage 3) melanoma. OS becomes much more of a focus for stage 4 patients versus stage 3.
When can we expect the Phase 3 trial for PV-10 to begin?
We expect the trial to begin this year.
When can we broadly expect Phase 1 data from the liver study?
We should have some evidence of the timing of this at some point this year since we are assessing the liver data we have now and we understand there is significant interest to publish now.
Given the latest licensing agreement, what is the next near-term catalyst that investors can broadly expect?
We expect additional MOUs from China, India, and perhaps a co-development transaction, all of which were discussed during our last investor conference call August 7th.
In consideration of the licensing agreement, what is the anticipated market opportunity for PV-10 in China upon MOU approval?
The MOU has been approved, but upon PV-10 approval in China, we anticipate a $30 billion plus market led by liver cancer.
Dosing has been adjusted in earlier trials of PV-10. Given the dosing information garnered from earlier data, are you expecting to adjust dosing more aggressively for Phase 3? What is the expected result of more aggressive dosing?
We are expecting to adjust dosing more aggressively, which could lead to greater complete response rates, longer PFS and longer OS.
What is management currently doing to maintain listing requirements?
Working closely with NYSE and developing PV-10 and PH-10 as quickly as possible to facilitate meaning partner transactions as quickly as possible.
At this time, what makes Provectus a compelling stock to buy or sell?
We believe Provectus is a compelling stock to buy now because of the announced MOU with Sinopharm and the clear expectation of starting phase 3 melanoma and phase 2 liver cancer studies. Data from these studies coupled with additional data from the Moffitt Cancer Center studies will accelerate the interest potential partners have in consummating transactions with Provectus.
Thank you for your time.
To see my initial interview with Provectus management, click here.
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it (other than from Seeking Alpha). The author has no business relationship with any company whose stock is mentioned in this article.
Editor's Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.