I attended the AM and below are my notes from the 2023 Provectus Annual Meeting.
All five directors were present in person this year.
All six proposals approved.
Dominic went over the slides that updated the progress of the company. Slides provided below but you must go past the first few pages to get to the slides. (See slides PVCT sent to investors)
After the presentation, Ed made a few comments, and one interesting remark is that PVCT is going to explore the possibility of having a conference call every 6 months to try and keep the investors more up to date on what’s happening with the company.
The 2022 Reverse Split was discussed and PRH stated that the events they hoped would be in place didn’t happen and they simply decided to not go forward with the R/S.
This is a good place to discuss the TGA event that we all thought would have triggered the R/S. I asked whether an application had been submitted to the TGA and Dominic commented that it was their policy not to comment on these types of actions by management. This is understandable based on previous actions by Dees and their public announcement that they had submitted a package to the FDA which was turned down because of the lack of significant patient data. However, there were comments from other investors in private that they had heard that PVCT had decided to not submit the package because TGA had decided that Intermittent Melanoma was not a rare disease and therefore was not eligible for being fast tracked. Consequently, management decided to not pursue this path of TGA regulatory approval and to go forward with the FDA or maybe with the normal TGA regulatory path (not sure).
There was an interesting discussion about whether or not the delays related to COVID was a blessing or a curse. Management believes that in the long run it was a blessing because it allowed them to open up many different avenues of potential RB use such as dermatology, virology, ophthalmology, and others. They believe without the COVID delays they would have gone down the oncology path and any other venues would not have been explored.
One of my biggest concerns has been funding. Dominic commented that they could go and get the money they needed at a price point that wouldn't necessarily be advantageous to the current stockholders, but that was always an option. They seemed fairly confident that they could find the money they needed to get the trials done without destroying the current stockholders' share position. The bottom line is the money that Dominic and Ed have been putting into the company was not to keep the lights on, but to progress the company's objectives towards regulatory approval by the FDA and maybe the TGA. Also of interest, there are individuals who have the ability to fund specific trials that interest them, and Ed is in discussions with them.
The question was asked regarding Bascom Palmer and negotiations for rights to use their equipment with RB to treat fungal keratitis. Many investors believed that negotiations have broken down. Dominic replied that this was definitely not the case and their relationship with Bascom Palmer was strong and that it was taking longer than anticipated because of the bureaucracy associated with the University of Miami (For Profit University) which is who Bascom Palmer is a part of. He also commented that their equipment is not what is doing the heavy lifting in treating fungal keratitis, but it is PV-10 and there are other equipment options.
A question was asked about operational costs associated with operations and trial costs and Ed commented that the company’s current spend rate is $250K per month.
In regard to the University of Tennessee’s grant for exploring PV-10 with animal sciences, Dr. Lacey stated it has taken a while to find the lead investigator for the study. However, they have now found the individual they need, and she is not only a veterinarian but also a PhD and they have every confidence in her and believe the outcome will be fruitful. In essence, the study is just now getting off the ground, but progress will be made. Unfortunately, the use of PV-10 in animal sciences in Australia will not be of much use in the study other than lessons learned from clinic use and practical applications. The lead investigator will have to start from scratch due to academic rigor although she will have the advantage of the information from the veterinarian’s use of RB in dogs (or other animals) in Australia.
The board of directors stated that they are trying to stay focused and putting everything on the back burner that is not related to their current oncology trials. They are concentrating on pancreatic cancer, metastatic uveal melanoma, stage III melanoma combo, and intransit metastatic melanoma (possibly TGA route, not sure) and will be moving forward with these trials. Also of interest, PVCT is trying to initiate PET scans in their trials because only PET scans are able to determine if the tumor is truly dead. A dead tumor may show up on a regular scan, but the Radiologist can’t tell if the tumor is dead or not and therefore won’t declare a CR without a PET scan. Regarding the date of conclusion of trials, there are a lot of unknowns such as patient recruitment, funding, successful readout of data and application to FDA/TGA, etc. Investor guesses is sometime within the first 6 months of 2024 and that is only a guess.
These are my notes, so if someone else was at the meeting and wants to correct or elaborate on my notes, please feel free to do so and my feelings will not be hurt.
Conclusion: I know we are all very frustrated with the slow pace that this is taking and the low share price and low volume. Management acknowledged our frustration and stated they are also frustrated with the low stock price because they are also stockholders. My impression is that by the next annual meeting, things will be significantly different. I also acknowledge that we have all thought this year after year. I've often said if making money in this stock was easy everybody would be doing it. However, this has been a very difficult investment for all of us and I believe in the long run it could very well be an investment of a lifetime. The Board Members believe PV-10 could be an industry disrupter and could completely change oncology. Not only do we have a great drug, but I believe we have good men on the board of directors. These thoughts are my opinion and based on years of being invested in PVCT, so take it for what it's worth.
