Provectus Biopharms

All right, as we have everyone loading in here, we will go ahead and get started. Good afternoon, good morning, good evening, depending on where you are. Welcome to Prevectus Biopharmaceuticals' fourth quarter investor update. My name is Alyssa Berry, co-founder and principal of investor relations firm Alliance Advisors IR. I am hosting today's call. Ed Pershing, chairman of Prevectus' board of directors and chief executive officer, and Dominic Rodriguez, board vice chairman and president, will provide 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. These 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.

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's worth would be driven by RBS's therapeutic strengths, patient impact, growth prospects, and market potential, rather than dictated strictly by financial-driven parties. Perfectus 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 Perfectus and or the company's future partners, underscoring Perfectus' potential strategic value in the biotech sector. We believe with numerous opportunities in front of us, that there is 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's 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.

Thank you, Ed. Hello, everyone. With regard to clinical stage PV10, 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 program, which would then allow us to work with Moffitt to begin patient enrollment. In regard to an 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 I 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 solution trial protocol, the protocol for delivering PV10 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 PB10 succeed for patients, we needed to be able to give as much drug as we could. PB10 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 PV10 is when either there is no more disease to treat, a good thing, or on the negative side when the PV10 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 PV10 was given in combination with CTLA-4, ipilimumab, or Yervoy, in combination with PD-1 or Obdevo, was that enough PV10 to 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 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, PV10 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 non-clinical data clearly support the systemic effects, benefits of the atrial tumoral administration of PV10. the MPDAC program in combination with chemotherapy essentially shines the light on PV10 in terms of if the study is successful for patients, then more credit, we hope, will be given to PV10 and its intratumoral administration than might be otherwise so if one were to combine it with a checkpoint inhibitor. A point to highlight with the penile SCC program is another strength of 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 conducting. trying to put forth with, again, an optimized or maximized clinical trial protocol, which is to put PB10 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 Baskin Palmer Eye Institute, the leading ophthalmology group in the US and very likely the world as part of the University of Miami Miller School of Medicine. We are forming a clinical stage biotechnology startup 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, NUCO, we've also referred to it in conversation and at meetings as ICO, to initially focus on treating infectious keratitis using rose bengal sodium. The current goal is to launch NUCO and close a seed round investment this quarter, the fourth quarter of 2024. Additionally, we currently anticipate a data readout of a phase three trial that involves Bascom Palmer's innovative ocular research, Rosbengel 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, Baskin-Palmer's therapy, Being run in India, we expect that Phase 3 randomized control trial to read out again this quarter. Finally, 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 companies. 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 up front, money based off of a couple of other milestones, where the post-money valuation of NUCO would range from $20 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 Muco and subsequent funding rounds that would provide investment for the new company to continue its path towards commercializing Baskin-Palmer's therapy. The funding at this point Initial stage would 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, 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 as a full package of information and data for FDA to help us understand what gap gaps remain, and what next steps, such as a bridging study, would then bridge from the current data set to what is required to achieve an approval. And of course, the funding would allow for us to secure the acceptance of an IMD for the use of rosemingle 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 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 NUCO 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.