Investigator initiated studies can be less expensive than company sponsored studies, and their data can potentially be utilized in regulatory agency discussions, assuming a well designed protocol is executed well with diligent and thorough collection of comprehensive safety, tolerability and efficacy data. This study has the potential to highlight both categories of PV-10s mechanisms of action. One, timely substantial or complete tumor response to PV-10 injection, thereby possibly reducing the amount of penectomy required or maybe even eliminating the need for it at all. Two, a potential robust immune system response mounted by PV-10 treatment. Provectus’ finalizing an exclusive worldwide license agreement with the University of Miami’s Office of Technology transfer for the Intellectual Property of Bascom Palmer Eye Institute’s Ophthalmic Biophysics Center for its rose bengal photodynamic antimicrobial therapy that has purportedly been used to treat more than 400 patients to date for infectious keratitis.
This licensed transaction could potentially be completed in March. Bascom Palmer has termed his treatment groundbreaking. Aside from collaborating on viable clinical proof-of-concept treatments involving rose bengal sodium that appear to work, seeking this license can marry Provectus’ potentially FDA approvable pharmaceutical grade active pharmaceutical ingredient with Bascom Palmer’s world-class expertise and worldwide reputation to produce a drug formulation based on the company’s potentially sustainable source of drug substance rose bengal sodium to treat patients worldwide, especially outside of the U.S., where infectious keratitis has a greater likelihood of leading to blindness. Ophthalmology is a possible disease focused majority Provectus owned, privately held spin out startup biotech business to which Provectus’ could contribute its Bascom Palmer license and exclusive access to the necessary supply of the company’s rose bengal sodium for this and other eye treatments.
Provectus has also made a patent application for the use of lower rose bengal sodium concentrations and ambient or no light, that is eyedrops for treating eye disorders and diseases. Provectus expects several data readouts from ongoing preclinical research. One, dermatology by the Rockefeller University. This work is important to further extend the original clinical PH-10 mechanism of action study in psoriasis, deepening investigation by including RNA sequencing. Depending on exactly how transcription is modified by PH-10 treatment, the implications for a range of skin diseases and potentially skin aging could be vast. Two, PV-10 and head and neck SCC or HNSCC by Moffitt Cancer Center. Provectus expects a medical conference presentation and a peer reviewed journal manuscripts of submission in 2024.
This work is important on several fronts including addressing both HPV-positive and HPV-negative HNSCC. Being supportive of the aforementioned potential clinical penile SCC work by reproducing the underlying preclinical research in two different research groups with different cell lines, differentiating the activity of single agent PV-10 and PV-10 in combination with checkpoint inhibition and potentially positioning PV-10 for first and or second line treatment when this indication enters the clinic. Three, full fitness cutaneous wound healing by the University of Texas Medical Branch at Galveston, the company expects a medical conference presentation in 2024. This work is important to demonstrate the therapeutic utility of lower Rose Bengal Sodium concentrations and ambient light compared to these researchers original line of investigation combining higher concentrations and green light.
A potential patient value proposition is rapid wound closure, scar mitigation or elimination, infection prevention and or return of function as well as a broader array of application environments. This research positions the use of Rose Bengal Sodium for surgical wounds and burns. Four, canine soft tissue sarcomas by the University of Tennessee College of Veterinary Medicine. This work is important to provide the necessary in vitro activity and in vivo safety data that enable a pre-investigational new drug and new animal drug or INAD meeting with the FDA and the eventual preparation and filing of an INAD application. A Phase 1 clinical trial at the University of Tennessee could potentially commence in 2024. Five, there are other currently proprietary research projects in process.
When we first joined Provectus Board of Directors, I spoke with and or interviewed several former biotech and pharma company executives to potentially assist us in writing the company at that time in 2017 none of them expressed substantive interest to advanced PV-10 or learned more about Rose Bengal Sodium. Well credentialed and experienced as they were, none displayed authentic interest in passion and perseverance for or curiosity about Provectus Medical Science and its promise for cancer patients and potentially patients suffering from other diseases. I believe the right pertinent, fulsome, exciting data set, such as from the company’s hepatic metastases pancreatic cancer clinical trial, can and will change their and others perceptions, reality and ultimately excitement to join our team.
We are for several Provectus corporate activities in 2024, including the company will try to continue capital raising efforts at valuations that respect its fundamental value. We plan for the company’s Board of Directors to appropriately consider undertaking and raising investment for possible disease focused spinouts to create one or more majority Provectus own, privately held startup biotechnology businesses. This may prove to be the most effective pathway to rapidly advance approvals of medical applications in ophthalmology, wound healing, animal health and or dermatology. Valuations ascribed to private biotechnology companies may be more immediately reflective of fundamental value than what the over the counter stock market currently for values Provectus add.
This possible unlocking of the company’s medical platform’s worth could be another means of enhancing Provectus shareholder value. Provectus plans to increase its investor communications and engagement and expand its visibility and outreach to the investment community. To this end, we have engaged our labs as a strategic communication advisor. Alyssa Barry, our labs Co-Founder and Principal has been hosting today’s conference call. There are no current plans for a Provectus reverse stock split. The company will continue to seek annual shareholder approval for such authorization as a tactical option. A reverse split is not a means to an end, but rather a means to address Provectus capital structure and potentially increase the company’s stock price, making Provectus common stock more attractive to a broader range of investors, such as institutional investors, professional investors and/or other members of the investing public.
