Provectus Biopharmaceuticals, Inc. (PNK:PVCT) Q4 2024 Earnings Call Transcript

Provectus Biopharmaceuticals, Inc. (PNK:PVCT) Q4 2024 Earnings Call Transcript November 14, 2024

Alyssa Barry: Good afternoon, good morning, good evening, depending on where you are. Welcome to Provectus Biopharmaceuticals Fourth Quarter Investor Update. My name is Alyssa Barry, Co-Founder and Principal of Investor Relations firm Alliance Advisors IR. I am hosting today’s call. Ed Pershing, Chairman of Provectus’ Board of Directors and Chief Executive Officer; and Dominic Rodriguez, Board Vice Chairman and President, will provide the company updates and their remarks today. Following the presentation, we will conduct a question-and-answer session. This presentation is being recorded, and a replay will be available on Provectus’ website. Management has cameras turned-off at the moment, but we will be turning them on for the Q&A portion of today’s call.

Today’s discussion includes forward-looking statements. As always, we want to caution you that such statements are based on management’s assumptions and beliefs. This forward-looking statements are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. Please see Provectus’ public filings for a discussion of these risk factors. I will now turn the call over to Ed for his opening remarks.

Ed Pershing: Thank you, Alyssa. First, I want to express my appreciation to each of you in attendance for this update, as we appreciate your interest in Provectus and our future success. We believe Provectus’ value will be determined by the unique capabilities of Rose Bengal Sodium, RBS molecule, the company’s proprietary synthesis process for manufacturing pharmaceutical grade RBS, and the numerous potential global market opportunities to address different unmet medical needs in an affordable and accessible manner for patients. Provectus’ worth will be driven by RBS’s therapeutic strength, patient impact, growth prospects, and market potential rather than dictated strictly by financial-driven parties. Provectus is currently has a unique position as the world’s sole provider of pharmaceutical grade RBS API.

Access to this API is essential for the development and commercialization of RBS-based therapeutics by Provectus and/or the company’s future partners, underscoring Provectus’ potential strategic value in the biotech sector. We believe with numerous opportunities in front of us that, there’s a dynamic opportunity and multifaceted business model for Provectus is essential to fully realizing RBS’s capabilities and the company’s intrinsic value and consequently, Provectus’ market capitalization. One of the specific examples of that is the work we’re doing in ophthalmology. This business model may have to be tailored to each specific disease area the company targets, potentially requiring different business strategies to maximize RBS therapeutic potential, Provectus’ market growth, and, thus, the company’s value.

We look forward to guiding the evolution and design of these business structures to ensure the market value of Provectus is fully maximized. With that, I’ll turn it over to Dominic.

Q&A Session

Dominic Rodrigues : Thank you, Ed. Hello, everyone. With regard to clinical stage PV-10, our cancer immunotherapy drug candidate and its application to injectable solid tumor cancers, we wanted to provide updates on our two programs. The lead program, metastatic pancreatic ductal adenocarcinoma or mPDAC. Our current goal is to secure an FDA Type C Meeting in the first half of next year 2025 to secure the clearance of — the clearance of the program, which would then, allow us to work with Moffitt to come to begin patient enrollment. In regard to investigator initiated study that another group, at Moffitt was interested in pursuing, There remains significant interest by them and potential funding for this investigator initiated study to, commence, and our current objective is to try to initiate a penile squamous cell carcinoma clinical trial, Phase 1 clinical trial in 2025 that would focus on, patients at the preoperative stage.

In both of these cases, we wanted to highlight and we appreciate shareholder feedback and at times criticism that Provectus is pursuing, the next new thing or shiny objects. When we look back at the clinical trials that have been run since Ed and I joined the company in 2017, the goal has been to fully understand what is the best clinical trial protocol, the protocol for delivering PV-10 that best puts patients in a position to succeed. And by succeed, we mean durable responses that ultimately lead to overall longer overall survival. When you consider or look at the many trials and patient cohorts, distinct patient cohorts that these trials have used, you realize that the two programs and their cohorts, one in cutaneous melanoma, one in uveal, identified or helped us identify that in order to have PV-10 succeed for patients, we needed to be able to give as much as much drug as we could.

PV-10 is an intratumoral administrative — is an intratumoral therapy, and so if there is disease to inject, i.e. a tumor, then we need to inject and, if necessary, re-inject in order to essentially then when you don’t need PV-10 is when, either, there is no more disease to treat, a good thing, or on the negative side when the PV-10 has failed the patient. And what we’ve seen from the cutaneous melanoma trial in combination with PD-1 KEYTRUDA the third cohort of that study. And then towards the end, the latter cohort of the metastatic uveal melanoma program where PV-10 was given in combination with CTLA-4, ipilimumab or Yervoy in combination with, PD-1 or Opdivo was that enough PV-10 given enough times over a long enough period of time, meaning again that there was the opportunity to inject and re-inject multiple lesions that we were we saw the promise of potentially longer survival in these single-arm studies that would underscore our thesis.

And so, with respect to the mPDAC program, that is the time taken that we bring to this study, as well as with high expectations that upon clearance and upon patient treatment, we feel very excited by this. The other aspect for choosing mPDAC understandably so when we first made comments about this study in 2018, again, was the needing to understand the clinical trial protocol and where we could maximize or optimize it for patient success. But also in those two studies, the cutaneous melanoma and uveal melanoma programs that I mentioned, PV-10 was combined with a checkpoint inhibitor. Given the skepticism that some have with respect to the local treatment generating a systemic benefit, we have no skepticism. Our clinical and nonclinical data clearly support the systemic, effects, benefits of the intratumoral administration of PV-10.

The mPDAC program in combination with chemotherapy essentially shines the light on PV-10 in terms of if the study is successful for patients, then more credit we hope will be given to PV-10 and its intratumoral administration that might be otherwise so if one were to combine it with a checkpoint inhibitor. A point to highlight for with the penile SCC program is another strength of PV-10. Again, here coming in as a pseudo scalpel to reduce or minimize the following surgery that may or may not need to be done for patients with this indication or this affliction. And so we’ve tried to be very careful in the studies that we are trying to put forth with, again, optimized or maximized clinical trial protocol, which is to put PV-10 in the best position to succeed patients where should the data be successful, it would be very difficult to be skeptical about them.

Alyssa, next slide, please. We have been talking since the earlier part of the year about the work in ophthalmology, and, of course, many of you have been following the work at, Bascom Palmer Eye Institute, the leading ophthalmology group in the U.S. and very likely the world as part of the University of Miami Miller School of Medicine. We are forming a clinical stage biotechnology start-up company, in order to pursue this disease area of ophthalmology, where the new company, which we are using for this presentation and sort of for sort of slang, NewCo, we’ve also referred to it in conversation and at meetings as EyeCo to initially focus on treating infectious keratitis using Rose Bengal Sodium. The current goal is to launch NewCo and close of a seed round investment, this quarter, the fourth quarter of 2024.

Additionally, we currently anticipate a data readout of a Phase 3 trial that involves Bascom Palmer’s innovative ocular research, Rose Bengal photodynamic antimicrobial therapy, in a setting where it is being compared to standard topical antibiotic, treatment for infectious keratitis. In this case, the indication is fungal and parasitic infectious keratitis. And we expect that readout from that trial funded by the National Institute of Health’s National Eye Institute using, again, Bascom Palmer’s therapy being run-in India. We expect that Phase 3 randomized controlled trial to read out again this quarter. Finally, we the new company currently aims to pursue a pre-IND submission meeting with the FDA in the first half of next year of 2025. So as we said, we, talked with the University of Miami, and part of getting to a license agreement that was mutually acceptable was to put forth that we would spin out or create a startup company to which Provectus would exclusively license — the license or assign the license from the University of Miami as well as also create an exclusive supply arrangement for pharmaceutical grade Rose Bengal Sodium to the new company.

The seed round, which would be issuing common stock for investment, would be up to $3 million in milestone based funding tranches, money upfront, money based off of a couple of other, fund, milestones where the post money valuation of NewCo would range from $20 million to $33 million of which Provectus through its common stock ownership of this subsidiary or affiliate, would be a substantial ownership that we hope would be reflected on our balance sheet. The valuation, of course, itself will be validated by the success of NewCo and subsequent funding rounds that would provide investment for the new company to continue its path towards commercializing Bascom Palmer’s, therapy. The funding at this initial stage will be to support completing the pre-IND submission meeting, which we will hope will clarify the pathway and define the timeline and cost for an initial approval for the treatment of an initial infectious keratitis indication.

Again, it is taking all of the clinical data that has been generated in South Florida at Bascom Palmer at, in India, Brazil, and Mexico where clinical data using the therapy has been generated together with foundational preclinical data in vitro or petri dish work as well as, in vivo safety data in rabbits in order to create a as full some package of information and data for FDA to help us understand what gaps remain and what next steps such as a bridging study would then bridge from the current dataset to what is required to achieve an approval. And, of course, the other the funding would allow for us to secure the acceptance of an IND for the use of rose mingle sodium in ophthalmology for the first time, as a therapeutic. That’s really important for us.

Finally, NewCo may raise up to another $3 million under the same terms, conditions, and valuations, providing potential flexibility if we think that there it is prudent to continue taking in money at these valuations with the hope and goal of raising money for what comes next at a much, much higher valuation than otherwise. So we wanted to give NewCo flexibility in terms of its business plan and its funding source. Alyssa, next slide, please. And Ed will talk here about how NewCo addresses an opportunity for Provectus monetization that reflects his earlier comments about the business model that we’re employing, at Provectus in order to really expand and monetize and make available Provectus’ platform. Ed?

Ed Pershing : Thank you, Dominic. Yes. NewCo really does reflect the structure that we’ve anticipated for quite some time, so you could consider it almost the first model for the opportunities that Provectus has in front of it. It’s a very dynamic business model. They may change from application-to-application, but it establishes basically, a clinical stage ophthalmology focused biotech company, in which Provectus were on a majority interest in it and, has been able to raise capital to proceed this opportunity without putting demands on Provectus. In fact, it has led to additional investment in Provectus by the interested parties. And so there’s a two phase benefit to this, to Provectus shareholders. And when you consider the potential valuations of such a company and Provectus owning a majority interest, I think it’s really apparent in how this could be beneficial to invest — to Provectus investors as it’s basically a non-diluted form of capital raise.

This is very much a high growth area. As we’ve noted previously in discussing, Bascom Palmer’s work in the field that is focused on now, it’s the second leading cause of blindness across the world. And, Bascom Palmer continues to pursue other possible applications for the drug in the ophthalmology space. This is basically as an example of our willingness to employ a versatile business model and what that can mean for the company. We believe this business model, may offer the opportunity to capture additional non-dilutive capital funding for Provectus, as we continue to pursue this, particularly if we have achieved the outcomes we expect in ophthalmology. And so, as shareholders, I think you should consider what this opportunity reflects in a unique way for better positioning Provectus in its financial position and financial future.

Dominic Rodrigues: In terms of manufacturing, thank you, Ed, we are currently working with our CDMO partner to produce a new clinical supply of PV-10, which, of course, is our immunotherapy drug product candidate for injectable solid tumor cancers. Importantly, for NewCo, in ophthalmology, we are working with the same CDMO partner to produce an initial clinical supply of PV-305, the, name we’ve given to the topical Rose Bengal Sodium based, ophthalmic drug that will be used in combination with their medical device for the treatment of infectious keratitis and potentially other indications and disease area and other, diseases of the eye. We want to highlight the importance of CMC, chemistry manufacturing and control, as it relates to consistently manufacturing a highly pure version of Rose Bengal Sodium, active pharmaceutical ingredient, and the strong data and capabilities on the CMC side that Provectus over more than a decade of producing, lots of this is essential to achieving regulatory approval and ensuring drug quality, safety, and efficacy.

We’ve seen examples, of course, of companies where, that stumble at the manufacturing stage. And while we are not saying that, we are immune to challenges with manufacturing, one of Provectus’ long-standing strengths is the CMC data having to learn how to produce, what is essentially near 100% pure Rose Bengal Sodium API. So it’s an important component to any drug development program, and that’s something that we want to highlight as well, and that we work on clearly in the background under the waterline, but almost as important as generating robust safety and efficacy data through the clinical trials. As many of you remember, we applied for a trademark of Veripure. This relates directly to the manufacturing where Veripure represents the branding, the name of Provectus’ proprietary technology and processes producing pharmaceutical grade Rose Bengal Sodium API at near 100% purity.

We plan, in the first quarter of sorry, the first half of next year, 2025, to introduce the idea of open source Rose Bengal Sodium medical research. Many of you will be have, follow. We hear this from shareholders all the time about research on the molecule. Like our — it is obviously research on many other molecules around the world. And we aim to become the primary global source for or of this pharmaceutical grade Rose Bengal Sodium for any and all non-clinical medical research on the Rose Bengal sodium molecule. The reason and the approach behind this is simply to enable that third party exploration of therapeutic and diagnostic applications in addition to our own. The message that we have for researchers is collaborate with us, Provectus, to create a potentially viable regulatory pathway for your innovation based on Rose Bengal to become a treatment reality for patients And, of course, the eventual creation of NewCo in ophthalmology is evidence of the collaboration work that we’ve done with Bascom Palmer and the University of Miami in order to arrive at that.

Despite 100 and 100 of patients being treated with row Bascom Palmer technology therapy, what Rose Bengal Sodium pharmaceutical grade API provides them is the opportunity to make all of that work a reality and scalable should we be able to achieve an approval of their therapy. The — we’ve taken early steps to establish, pharmaceutical grade Rose Bengal in academia by in advance of a Veripure launch by, of course, journal articles that reference, the notion that Provectus has this quality of API. Ed, would you round out the discussion of Veripure, and the Provectus’ platform?

Ed Pershing : Sure. In basically, in concluding this part of our presentation, I wanted to share with you just this month, I was approached by a, medical research scientist with a technology they developed for drug delivery and because of their awareness of Provectus’ approach to drug development and the model we’re using. And, I have a very unique, program that they’ve spent almost 20 years in development. And it’s just one example of how as this space becomes aware of what Provectus is doing and, our openness to consider basically open source technology. They were aware of our, intratumoral therapy applications and from that and how we’re advancing Provectus beyond that, made it a very attractive opportunity in their eyes to approach us about could we possibly work together.

And so that’s a very tangible recent example of, why we believe this business model is going to be fundamental to Provectus’ ongoing success, but also in a way that will increase the value of Provectus while also advancing new and better technologies for addressing cancer and other diseases. And so, one thing I find so encouraging of this is the flexibility it provides us not only for drug development, but also in the aspect of raising capital in a non-dilutive fashion that directly benefits shareholders and investors. So, I’m going to call turn it over to you, Dominic on other research.

Dominic Rodrigues: Thank you, Ed. Provectus has a third clinical stage drug candidate PV-10, and we are anticipating the initiation of a large animal study in the first quarter of 2025, which is really be the intersection of, the company’s research programs and a collaborative effort by the Rockefeller University in New York City and the University of Texas Medical Branch in Galveston. The non-clinical study, will use a drug formulation to target a range of dermatological conditions as well as treat full thickness cutaneous wounds, showcasing, again, expanding applications in both dermatology and advanced wound care. What we feel very excited about, obviously, is this collaboration highlights our commitment to addressing indications, diseases, disorders that are global in nature.

And in particular with dermatology based also on foundational clinical and non-clinical work that has already been done, provides a particular opportunity for a very large growth opportunity for us that we hope once this work is wrapped up, we’ll be in a position to have a fulsome dataset and to be able to promote this program more. Finally, in canine cancers, as you know, we’ve been working with the University of Tennessee College of Veterinary Medicine to establish a foundational non-clinical research dataset in vitro activity and in vivo safety of PV-10 for treating soft tissue sarcomas in dogs. Unfortunately, that work has been surprisingly inefficient, notwithstanding a lot of non-clinical and very relevant data from Provectus and its collaborators as well as in the literature.

And so, we’re currently our current objective is to refocus this program towards developing an investigational new animal drug application that leverages more of the existing human data and cross references PV-10’s existing IND investigational new drug form in order to streamline canine drug development and we’ll have more information on that in the coming quarters. And then in regards to pending journal articles, we expect articles to be published about the non-clinical head and neck squamous cell carcinoma work that was done by Moffitt and presented at AACR earlier this year. The clinical work done, for treating metastatic neuroendocrine tumors that, presented on the liver by Australian clinicians and then, of course, work done in a non-clinical fashion looking at tissue regeneration and repair, at the University of Nevada, Las Vegas.

Again, the goal here is to continue putting forth, research from the company, but also being able to then stand upon these, as we reach out with Veripure, and encouraging other researchers to collaborate with us to receive Rose Bengal Sodium pharmaceutical grade from the company in order to power their own research and realize that their dreams of getting a treatment to patients can we believe can be made reality by partnering with us and having a sustainable, consistently produced high purity version of the API for eventual acceptance by regulatory bodies. And then with that, I’d like to turn it over to Alyssa, who will moderate the Q&A with, Ed and myself.

A – Alyssa Barry : Thank you very much, Ed and Dominic. That was great. Appreciate the overview. I am going to, open it up to, the audience for questions. There is a Q&A function or a chat that you can, enter your questions into. So we’ll just give it a minute, and, we will then open up, to questions.

Dominic Rodrigues : And we’ll be turning on our cameras?

Alyssa Barry : Yes. Thanks, gentlemen. So question that has come in around collaboration work. Can you just there’s quite a few opportunities for collaborations underway. What else is there, that might be cooking, that, you’re able to share?

Dominic Rodrigues: Sure. Ed, would you like me to just address the, the questions here?

Ed Pershing: Yeah. Dominic, you want to hear. I’ll mention the one, different stages, and then Dominic can go into further details. But one of the things that is occurring is getting more inquiries because of, how we’ve advanced this and the term that Dominic, initiated similar to technology companies, the open sourcing of our molecule, I think, is creating interest. Even those that are not in direct drug development, but knowing the approach we’re taking for advancing, this drug technology is leading to inquiries, and, that’s very exciting. The one I referenced in my earlier comments was, a, something that’s been, the passion of a medical engineer for well over 20 years. And when I was contacted, it immediately recognized some of the benefits that could also bring to Provectus and how we utilize PV-10, particularly in very challenging medical cases.

Dominic Rodrigues : Yeah. In regards to partnership, look, we have said at past meetings that we in past calls that we do have gone and shared, select data with pharmaceutical companies and gone under CDA with them for their evaluation. Ultimately, what we feel is that the at least in terms of PV-10 for partnership, that the mPDAC study is the one that would fully display the vast potential of PV-10 with optimized clinical trial protocol that would maximize the outcome for patients and be able to demonstrate its immunotherapeutic capabilities, we hope, it being PV-10, when combined with chemotherapy for a really tough indication. And so all of that work and the knowledge we’ve gained and the feedback positive and critical about the data that Provectus has generated since inception from third party pharmaceutical companies puts us in the position where we believe that it’s the mPDAC study that we need to focus on.

It’s a well-designed, well developed protocol, and that, from the dataset that emerges from it will dictate the future of PV-10, and its initial approval pathway.

Ed Pershing: I would add to that, for the shareholders, the, note that, the PDAC is basically we do not believe this first step we’re taking will be that capital intensive, and it can be conducted over a relatively short period of time compared to most clinical trials and yet could have enormous, evidence of clinical benefit in these very challenging cases. And so, there’s a lot of reasons for going down that pathway.

Alyssa Barry: Thank you, Ed. Dominic, maybe this is a segue to a question around timing for mPDAC. Is there any anything we can comment on there?

Dominic Rodrigues: Yes. So we would expect that the trial would start within a quarter and/or two quarters after, we’ve received clearance from, the FDA. And that assumes, of course, that trying to work in parallel that the study is teed up to go at Moffett. As we said at the annual meeting, we’ll endeavor to provide feedback or updates as the trial starts. And then to the second part of that question in terms of when the first data, you’ll have a good sense once we have an — once we start the study, these patients typically have a rough a median survival of four to six months. And so, from there, that will tell you that as patients are being recruited, we’ll have a very good sense of how the study is doing really measured in quarters, unfortunately. But the longer that the study can be pushed out, then presumably patients are doing better rather than worse. And so, we’ll provide those updates as much as we can when the study commences.

Alyssa Barry: Thank you. A question here around the canine, cancer work that we’ve been doing. Can you, talk a little bit about the outcomes and the approach?

Dominic Rodrigues: Sure. I’ll give some comments, and then I think Ed has a more macro perspective as it relates to all of the research collaborations in the different areas that we’ve worked in. So, you have heard us say over the years that the molecule is quirky, and it really takes a lot of effort and perseverance and then sometimes resilience by the researcher to work through these quirks in order to understand what they’re seeing and let their scientific curiosities and experiences in their specific specialty area, expand and grow. And so, unfortunately, sometimes programs happen such as, some COVID work that was done with the University of Tennessee Regional Biocontainment Laboratory, where there’s some initial hiccups that need to be overcome when they’re working with the molecule, when they’re trying to understand how it works with cell line strains, or, in, administering it, let’s say, to rabbits for safety.

Sometimes, clinicians or researchers with, not a lot of experience with the molecule and making, assumptions based off of their prior experience end up sort of stubbing their toe in terms of being efficient and effective. And so, we often work with these researchers using leveraging all of that vast amount of knowledge that the company has generated, in order to help them through, the program. Sometimes — most of the time, it works. Sometimes, it just simply doesn’t because, they need to be a little bit more open minded. They need to be sort of flexible in terms of working with the molecule. We have a very, very strong track record of reproducible, record of reproducible, repeatable science, and so sometimes it just it happens that, the law of averages that the one in a hundred physician just needs struggles with it, and we need to work with them to overcome that.

Alyssa Barry: Looking at a couple of different, sorry there. Did you want to build on that?

Ed Pershing: Yes, I’ll just say great Dominic comments. In each step of the way, we have had to do a lot of coaching, and sometimes, that just adds to the delays to getting outcomes. But, we look forward to continuing to pursue collaborative, arrangements, and we have — we’re very excited about what the future holds in that space.

Alyssa Barry : Thank you, Ed. There’s several questions around, timing. I know we’ve got shareholders, very excited and anxious, about the various projects underway. Dominic and Ed, can you just talk a little bit about the approach, of, I’m calling it the diversification of opportunities? And, I know there’s these processes take time. Is there anything that you can comment on in terms of, timing and approach for all of the different trials and projects underway?

Ed Pershing : I’m going to come by and I’ll take the first part, and then you jump in. I’m well aware of people’s concerns. Some have posed the question, are you pursuing too many different areas of development? As Dominic and I use the phrase are we chasing the latest shiny object? And that is not the case. In each of these that we’ve pursued and some continuing to pursue, basically, it is not in any way diverting us from our focus on the drug and in cancer applications. What it is, it’s building out more knowledge, and also in each case — it’s requiring minimal financial resources while creating the opportunity for potentially very significant financial, gain in the future. And so, it’s something that we’re very, mindful of.

I would use the most recent example then which I encountered, and it’s because of the direct potential benefits to Provectus’ use of PV-10 and potentially other molecules that saw potential synergistic benefits. But it would be a very, very low cost, development pathway. And so, just want to as we discuss opportunities, we are very mindful of the consideration of time, resources, and financial resources.

Dominic Rodrigues: And I’ll add, with respect to, for example, with, mPDAC, we spent almost a year finalizing the clinical trial protocol. So there’s a lot of component parts that need to be get some need to be addressed, such as an FDA meeting, getting into the lane for Moffitt to begin the study. And so those are the things that we’ve been working on, and we’ll be very clear about when we will start that trial because you’ll hear us give guidance that we will start the trial. And so, hopefully, you’ll hear it from the horse’s mouth. In regard to, the Miami project I mean, the NewCo for ophthalmology, we say the timing is this quarter. Work is being done. And when we’re ready to announce that, again, to formally launch the company, we’re working with Alliance Advisors, to do that as well.

They were consequential in a lot of our branding work, names, logos, et cetera. And so we’ll be in a position to then again make more of an announcement when we’re ready. And to Ed’s point, something like, ophthalmology and NewCo presents an opportunity to generate non-dilutive funding for the company. We have an incredibly bioactive synthetics small molecule. I think it’s pretty clear, the amount of research that Provectus and its collaborators as well as unrelated and unaffiliated third-parties have done. And so, we’re looking for different ways in which we can create shareholder value, promote or encourage the use of Rose Bengal, establish it with a strong science foundation that is reproducible and repeatable, and that essentially provides more shots on goal and more potential value for shareholders.

And so, that is what drives the way in which we’ve been trying to increase the number of opportunities for Provectus to reward shareholders with value. And we understand, the time that it’s been taken. We understand that shareholders at times may be impatient with us, but we continue to focus because we think that the science outcomes that we’ve seen and the data, non-clinical and clinical, clearly support the opportunity and will continue to execute while always being mindful of, dilution potential for shareholders.

Ed Pershing: I’ve got one pointed comment to Dominic’s. I think the AECO is a great example of, the benefits of this because imagine the fact that we should be seeing the results of approximately 330 patient random control trial, here next month in which, has been of no cost to Provectus us and has not impacted our time demands or financial demands. And so, yet, we can be a direct beneficiary of that work, done in India as well as Bascom Palmer’s work that they’ve already concluded.

Alyssa Barry: Maybe that’s a good segue to a couple of questions around how do we further improve or expand our patient recruitment. Can you comment on that?

Dominic Rodrigues: Sure. In terms of patient recruitment, so both organizations, both oncology departments and Moffett feel very comfortable with, patient recruitment. And in large part, we’re focused on single sites, because we need to demonstrate very robust and, albeit, they are single arm studies to, generate high quality data. And by high quality data, we mean successful outcomes for patients. And so, rather than, have multisite, early-stage clinical trials at this stage, we’d rather work with sites and investigators, who are passionate about the application of PV-10 to a particular disease indication that they’re trying to solve. And so, we understand there were questions about past recruitment. We think that recruitment was generally, okay, can always be better.

But in these initial trials that we’re running in mPDAC and penile SCC, the goal is to make sure that there’s a sound foundation, that the data makes sense, that there’s a clear pathway based off of that data for approval, and then we can move to multicenter sites or studies, where, again, the success of the data generates, we hope then, market capitalization and the ability to raise funds that would then fulfill those multicenter sites where we hope enrollment will be strong because of the results from the prior study.

Ed Pershing: Yes. I’ll just add, Don, to your comment. The specificity at which we look at, probable patient enrollment is a key consideration as we make decisions. And so, we’re not relying upon outsiders. We’re actually looking directly at what the institution is able to recruit and the physicians involved in their past and current success in patient recruitment. They’re standing, not, from a national standpoint as far as, their programs, as we make these decisions. So as far as realized before we got control, there was in the prior melanoma trial, there was very poor patient recruitment, but I assure you we’re very attuned to patient recruitment, capabilities before we begin any initiative.

Alyssa Barry : Thank you. Question around, status of POETIC.

Dominic Rodrigues: Sure. So we appreciate that shareholders might project, outcomes on us as it relates to programs. What we often do is encounter challenges with, programs or, partners or situations. In the case of POETIC, we were on the cusp of a clinical trial that had been finalized by one of their advisors and were ready to go. And, unfortunately, due to, circumstances that didn’t appear related to the protocol or the pediatric relapsed and refractory cancer program, aspects of leadership of POETIC decided not to continue. Having said that, one of the most — one of the component partners one of the partners of POETIC, the University of Calgary, the Cumming School of Medicine, Dr. Aru Narendran, has been as many of you have been following one of the most prolific researchers for us as it relates to not only initially validating, PV-10 in nonclinical work for pediatric relapsed and refractory tumors.

He also then continued to do work across a wide range of other areas at our behest where he showed oral administration for — if for a hematological indication for solid tumor cancers where he enabled, in silico or computer modeling during the coronavirus, of that that led to work that we did to understand, in an in vitro and in vivo settings the potential to administer the drug in different ways in order to see its antiviral properties. He’s also been instrumental in some other, proprietary targets that we’ve been working on. And so we have been in in many respects working with POETIC, but it’s lead research site. And, there will be an Ed references of a meeting that he held where there may be an opportunity to pursue a pediatric indication with probably, a rather notable institution, but it’ll take some time for us to get to that point.

But sometimes you’re ready to go, and, something other than strong science and a strong patient rationale might divert the program. We feel that the POETIC relationship was fantastic because of what it produced in terms of a relationship with Dr. Narendran and the prolific work that he did that opened our eyes to the vast potential, the reason we call this a bioactive molecule. So, hopefully, that’ll give you some feedback on that. Ed, do you have any further comments to round that out?

Ed Pershing : No. I view the POETIC relationship, while and I have my own personal observations as far as why it wasn’t pursued from a north across the POETIC organization. I think it centered on just a couple of people. But the benefit of that relationship has been vast and identifying opportunities for Provectus to pursue and just a great cannot ask for a better partner than Dr. Narendran. He is very instrumental in our success.

Dominic Rodrigues : And, and, Ed, I’ll just throw in. Sometimes, prospective partners, partners don’t understand the molecule that we have. I will give it we’ll share a story where in the meeting where one of the leadership of POETIC and a pediatric oncologist liaison from a large pharmaceutical company that is quite well known, while Dr. Narendran was giving his presentation of his in vitro work, raised what I’ll call rather unintelligent questions about his work, not understanding that the level of concentration in those studies using Rose Bengal Sodium is higher than what they’re familiar with other compounds, meaning that, you can use a higher level of dose for PV-10 than you could with other, drug agents. And they didn’t understand or thought that, there would be some of systemically toxic outcome from the petri dish work that he did.

Not understanding again that at that, point in the late 2010s early or late 2020s when this meeting occurred, that Provectus had a significant amount of non-clinical toxicology data, PKPD data, as well as a strong amount of established safety data in clinical trials of people that would have given them a better understanding of how to use our molecule. And so, sometimes, again, we need to work harder to show and to help partners understand and get, I guess, let go of their preconceived notions and their assumptions. But, ultimately, I think, a study like the mPDAC one and the time it’s taken and the careful design and, trying to blow away or answer any and all skepticism, ultimately, then it just boils down to the data where you’re ready to push your chips into the middle of the table, in a risk calculated way, and you think that study really will produce the answers we hope, that prospective partners and other organizations are looking for.

Ed, do you have any other comments on that?

Ed Pershing: Yes. I can’t help but comment on that one, Dominic, because I if you got your screens on, you’ll see me smiling because I was considering telling that story that Dominic just shared in my earlier call, and I thought I’d back away. So let me just be blunt about it. Literally witnessed what Dominic, we were in the room when that occurred and realized and I watched that impact of those statements, which basically were made without adequate knowledge of what we have, and I saw it by a POETIC leader. And, to me, it distills what we encounter, and I’ve encountered across my career so many times in medicine. There’s some inherent biases just because of past experience and lack of knowledge of something new and unique. It ends up leading to a bad decision.

But it did related to the cross POETIC, but it ended up being a benefit for us, because it really allowed us to drill into a much deeper relationship with doctor Narendran. And we were able to move faster, quicker, and further, I think, as a result of that as far as what are the capabilities of the drug. And so, there was a lot of great things that have come out of that. But, what Dominic just shared was the key event in which across POETIC, we quit pursuing a broad relationship and focused on doctor Narendran, just to be totally transparent.

Alyssa Barry: Thanks, Ed. Quick one for you here. Are we still pursuing approval in Australia? You’re on mute, Dominic.

Ed Pershing: You’re on mute, Dominic.

Dominic Rodrigues: Yes. So, we were looking at that as an avenue with the data that we have. Again, I think we mentioned this at the annual meeting that running an approval or looking at a drug approval pathway for cutaneous melanoma, given all of the approvals and the landscape of it now, would require 500 to 700, maybe more patients, and, several years because it’s more than likely that the primary endpoint will be overall survival. And when you look at the financial component of that in terms of the cost to run that study, it’s more and opportunity for a PV-10 led combination because it ultimately would be a combination study using the various standards of care that have been approved over time. The results would not be, the spending money on that as opposed to, let’s say, mPDAC, where you’re partnering with chemo and you have the opportunity to demonstrate, we hope, success with progression free survival and then ultimately overall survival in a pivotal or confirmatory study.

It just simply makes more sense for Provectus to — from a financial resources perspective, to pursue mPDAC rather than looking at a melanoma study, whether the approval is sought in Australia or globally.

Ed Pershing : I will share this. We did develop even broader relationships with the leading, oncologists and oncology surgeons, and even oncology pathologists across Australia. I think the total significant relationships now is at 12. And, they are strong supporters of what the molecules’ capabilities are. And now, Dominic, I think we have an expected paper coming out related to neuroendocrine tumors in the near future.

Dominic Rodrigues : Right. So we value the work that we’ve done there, and it is contributed to, again, optimizing a clinical trial protocol that we think has the potential to put each and every patient that gets PV-10 in a position to succeed with the disease that they have. But we’ve got to pick and choose our spots in terms of being prudent about financial resources and how we move the company forward.

Alyssa Barry : Great. Thank you. Question here. Please expand on the details of a Bridge trial. Is this the same as a P4 trial?

Dominic Rodrigues : Yeah. So we don’t have so, again, we’ll provide more information, when the new company approaches the FDA for a pre-IND submission meeting. We need to hear FDA’s feedback on, the situation, which is essentially, it’s the same molecule, but Provectus has the clean API, and, the prior data was generated from commercial grade material or non-pharmaceutical grade, and that will help define what the parameters of that bridging study are. Certainly, the readout from the India study, the Phase 3 will contribute. And so once we have that feedback, the minutes from that meeting certainly will be in a much better position to update shareholders.

Alyssa Barry: Great. Thank you. Question here around which programs do we believe are the furthest along in approval maturity, and is there an estimated deadline to see revenue generation from, RBS?

Dominic Rodrigues : Sure. It’s always good that we can get something related to RBS to generate revenue and hopefully profit. In terms of the maturity of the programs, you’ll see that we have a Phase 1 trial in metastatic pancreatic cancer even though the company has had prior to Ed and I joining that was already embarked on a on a Phase 3 randomized trial, which we look at the bright side of that, which study we had to terminate, because of the vast analysis that was done on the CMC features of PV-10, whether it was FDA, whether it was Germany’s b-farm, which has a long reputation for being very focused on, CMC. So, we went to a Phase 1 study, which while — it would seem that your — it it’s sort of going steps back. It’s simply filling out the dose escalation, dose optimization checkboxes of Project Optimus for FDA in terms of designing clinical trials.

Hopefully, with the existing data that we have together with the new data generated in that study and, hopefully, positive outcomes, we are net in a position to move into design some program that either accelerate approval or Phase 3, 4 in PDAC. Ironically and interestingly, what the work which is farther ahead would be the work by that comes out of Bascom Palmer in terms of the number the hundreds of patients that have been treated for infectious keratitis. But interestingly, a NIH funded Phase 3 RCT where for the first time, you would be comparing Rose Bengal in a therapeutic setting in a in a randomized controlled trial. And so that’s why we’re very excited by that work, understanding that we’re al, on pins and needles as it relates to the outcome of that study, but it does provide an opportunity, when you’re in any randomized clinical trial to demonstrate clinical benefit, comparing a treatment, with standard-of-care versus standard of care alone.

So in terms of which is farther ahead, it’s interesting that, Bascom Palmer may have generated or developed a program that is farther ahead in terms of its generating sort of comparative data than, what we have. And so that’s probably the way we’d look at it.

Ed Pershing: To stay to that, Dominic, the fact that, you know, in the India trial, it’s going to be over 300 patients. And, that was NIH initiated, so that brings a connection, of our drug to NIH that would not have existed absent, the eye care work. And then also, one of the things I found in talking to potential investors, there’s nothing more effective about proving the non-toxic nature of Rose Bengal Sodium than talk about it being used in the eye. From a layman’s perspective, that pretty well indicates just how safe it is. And so, it has a number of benefits to our efforts in advancing the company that the ophthalmology work is as far along as it is, and it’s been at virtually no cost to the company.

Alyssa Barry: That’s great. Thank you. Question here around the type of organization that will be needed to move EyeCo program forward. Have we had large medical companies such as Merck show any interest in forming a company with Provectus?

Dominic Rodrigues: Sure. We’re trying to do a private company, C-Corp, down the middle of a fairway that would essentially be the vehicle for EyeCo or NewCo. Again, we’ll unveil the name, this quarter. And, it’ll be a straightforward organization that can raise fund money from venture capital organizations, whether private or corporate can raise money from companies as it advances. In terms of we see companies like the like the question raised, Merck, looking for revenue sources, and I think last earlier this year, closed the transaction with a ophthalmology, company. And so there is a good number of prospective partners, from the obvious, Alcon, Novartis, Bausch and Lomb, etcetera, as well as other smaller public companies, smaller meaning measured in billions of dollars of market cap.

And so, again, once we are in a position where we have a day and we have an investor slide deck, and we’re really candidly just waiting for to launch the company and, be in a position to then start knocking on doors to generate interest. We have work to do, and we’re grateful to the prospective seed investors for the funding that they provided to pull together data, go to the FDA, get a perspective on the size, scope, timeline, cost of the bridging study. But even though you may not be immediately asking for money today, you certainly want to make prospective partners aware of this work, particularly because, again, Bascom Palmer’s reputation precedes itself. And so, that we need to get out and do that, but we’re waiting for the timing in order to be able to knock on doors and introduce people to the new company.

Ed Pershing : I would just emphasize, it could be a relatively short timeline to seeing, if we achieve the results we hope to achieve to seeing a dramatic increase in the valuation of our code, which benefits Provectus, with minimal cost to Provectus. And so it’s, something I would call on the immediate to intermediate horizon that could have a very significant positive impact.

Alyssa Barry : Thanks, Ed. Lots of really great questions. I wanted to keep I know we’re right at the hour, but I wanted to keep running through the questions. But, Ed, I’m going to turn it over to you to for closing remarks. I’ll, pull up your slides here, but, but please go ahead.

Ed Pershing : Okay. In closing, Dominic and I and our team recognize one of the key, interest and most common questions we get from shareholders centers around value, whether that’s reflected in kept value or the share price most common, the share price. And, hopefully, we’ve conveyed, today why we are so confident about the value of the company, the future value of the company, and it’s all comes back to the molecule and its unique capabilities. And the fact that we’re the only company in the world that can manufacture it to, pharmaceutical grade products. So, we’re in a unique position and could not be more excited about that. I think also, today’s, meeting, and, again, we appreciate your time. It gives us an opportunity to use the EyeCo model as an example of the various business models that may be initiated as we continue to advance Provectus’ interest in bringing this, drug agent to treat various diseases.

And do so in a fashion that is as being sound stewards of the company and trying to do things in as, prompt in this reasonable fashion as possible, but also being mindful of risk, whether it be financial risk or market risk or medical risk, do so in a responsible way that to advance the company to achieve its full valuation. And I would close, we all we are always trying to consider all aspects. And so as my closing comment, I would just call to your attention the macro environment. We’ve the companies had the countries recently had a presidential election. There’s a lot of speculation about what that’s going to mean to the various, agencies, one of which is oftentimes mentioned as the FDA. And, I would say, as we consider those, we don’t know what the impact of that will be, but we feel like we’re well-positioned, regardless of the impact to be able to approach FDA with sound information, and do so in a fashion that we’ve tried to execute across this journey to where, we can, be successful and do so in as timely fashion as possible.

And so, we just appreciate your support, your interest in it, and, hopefully, you understand why Dominic and others are so confident about the Provectus — about the future of Provectus and what it holds for shareholders.

Alyssa Barry: Great. Well, Dominic and Ed, thank you very much, for today, and thank you to our shareholders for being here, for your support and for your questions. Wishing everyone a really great rest of your day and holiday season ahead. Thank you.

Ed Pershing:

Alyssa:

Dominic Rodrigues:

Alyssa: