Provectus Biopharmaceuticals, Inc. (PVCT) Earnings Call Transcript & Summary

Hi, everyone. For our guests who are just joining us, it's great to have you here. We are just doing a sound check in the room and swapping out a microphone. So please just give us a few minutes to take care of that, and we'll then get started. And one more time for our guests who are just joining us, welcome to our AGM. We're just doing a sound check in the room. So we just need a couple of minutes to swap out a microphone, and then we will go ahead and get started. We appreciate you being here.

Okay, Alyssa. So we removed the mic. And so yes, we'll just speak to the room and keep this on mute.

Excellent. All right. Dominic, I'm going to take that as your queue to go ahead and get started if that works for you. I'll just let you get back into your spot. Okay. Awesome. All right. Well, welcome everyone, to the 2025 Annual General Meeting of Provectus Biopharmaceuticals. My name is Alyssa Barry, Investor Relations for the company. And whether you're joining us in person or virtually, thank you for your time and interest and continued support. [Technical Difficulty]

Unfortunately, we can't -- we're still working on the speaker for the room.

Okay. No problem. For those joining us virtually, this is the part where you'd grab cookies and tea while we test all the technology if you were in person. So thanks for your patience.

Alyssa, if you want to just kickstart it and then we'll...

You got it. My remarks are housekeeping only. So let's get my business out of the way, and then we can get down to the real business. So welcome again, everyone. I appreciate your patience as we sort out technology today in our hybrid world that we live in. Welcome to the 2025 Annual General Meeting of Provectus Biopharmaceuticals. My name is Alyssa Barry, Investor Relations for the company, and thank you all for joining us in person. And for those who are virtual, thank you as well for being here. Before we begin, I want to highlight a few housekeeping items. This call today is being recorded on Wednesday, June 18, 2025. And questions can be submitted through the Q&A function and will be raised at the appropriate time. And we will do our best to address all questions that come through. We'll follow the lead from the team in person who will be taking questions from the floor, and then I will moderate virtually as well. Please note that today's remarks may include forward-looking statements that reflect management's expectations, estimates and projections regarding future events. These statements are based on current assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. We encourage you to refer to our most recent filings and disclosures for a comprehensive discussion of those risk factors. I'm very excited for us all to be here again this year. And with that, I will be turning it over to the team in person if they give me the go ahead that they're ready.

Yes, we are listening. Can you turn on the slide show first, Slide 5?

Yes, you got it.

So you're going to hear some feedback. Yes.

No problem. The slides are just going to pop up here in 1 minute here. Okay. Great. You'll see them full screen.

Alyssa, is the feedback tolerable on your end?

The feedback is a little tough. We can hear it, and I'm sure our guests virtually can hear it as well.

I think what would happen today, we can project where people in the room can hear us. I think we just have to put off these speakers.

I think that makes sense. And then when I open up for Q&A, we'll -- it's only, I guess, my voice virtually that we can handle at the end, and we'll figure that out. Not a problem. I think that's a better bet.

Yes, because everyone -- opening comments.

You got it. And Ed, do you see the slides up on your side as well?

Yes.

Okay. Super.

Good afternoon, ladies and gentlemen. On behalf of Provectus Pharmaceuticals, I'd like to welcome -- extend a very warm welcome to those here in Knoxville and those that are attending by Zoom webinar. Thank you for attending the Provectus 2025 Annual Meeting of Shareholders. I would note that Dr. Lacey obviously has great influence. He can create these kind of issues to where he has time to get here. So we have all the Board members present. Appreciate that. I'm Ed Pershing, Chairman of Provectus Biopharmaceuticals Board of Directors and Chief Executive Officer. We would like to call the meeting to order and to entertain a motion from a Provectus stockholder to elect the Chairman for the annual meeting. My voice has been failing for over 2 weeks, and I'd like to save it for the Q&A session. So I've asked Dominic Rodrigues to serve as the Chairman at this annual meeting.

My name is Webster Bailey. I'm also a member of the Board and I -- also a Provectus shareholder, and I second the motion.

As such, I move that Dominic Rodrigues be elected to serve as Chairman of the Board. And with that second, all in favor, say aye. [Voting]

Aye. My name is Dominic Rodrigues, and I am President of Provectus, a member of the Board and a company stockholder. I hereby accept the appointment and meeting -- as meeting Chairman. I also appoint Nathan Kibler of the law firm Baker Donelson and Provectus' outside legal counsel as meeting secretary. Before getting further into our annual meeting, I would like to introduce our company directors and officers who are here today: Heather Raines, our Chief Executive Officer; our Board members, Dr. Jack Lacey, Webster Bailey, Ed Pershing and myself, Dominic Rodrigues. On the phone -- on the Zoom, we have our PR firm, Alliance Advisors, and also our external auditors, CBIZ. We'll now take care of preliminary matters before proceeding with the stockholder votes. The Board has appointed Ed Pershing to act as inspector of elections. The Board set April 21, 2025, as the date of record for this Annual Meeting of Stockholders. As of this record date, there were 420,279,879 shares of our common stock outstanding, 956,985 shares of our Series D convertible preferred stock outstanding and 13,488,612 shares of our Series D-1 convertible preferred stock outstanding. Each share of common stock entitles its holder to cast one vote, each share of Series D preferred stock to cast one vote and each share of Series D-1 preferred stock to cast 10 votes on any matter to be voted on at the meeting. Under Delaware law, the presence at the meeting -- at the annual meeting in person or by proxy of holders of a majority of the shares of Provectus' common stock outstanding on the record date will constitute a quorum. Immediately prior to commencement of the meeting, the inspector of election has determined that the holders of approximately 62.92% of the outstanding shares of common stock were represented by proxy at the annual meeting. Therefore, a quorum is present. The meeting is duly constituted and its business may proceed. I guess...

Mr. Chairman, my name is Ed Pershing. I'm a Provectus stockholder, and I move to waive the reading of the notice of the meeting, the affidavit of mailing of the notice, the proxy materials and the minutes of last year's annual meeting.

Mr. Chairman, my name is Webster Bailey. I'm a Provectus stockholder, and I second the motion.

You have heard the motion to waive readings of the notice of the meeting, the affidavit of mailing of the notice, the proxy material and the minutes of last year's annual meeting. All those in favor say, aye. [Voting]

Aye.

Aye.

All those opposed, say no. [Voting]

The motion is carried. The meeting secretary will please insert the notice of the meeting, the affidavit of mailing of the notice and the proxy material in the minute book of the company. At this time, we want to collect all stockholders' proxies that have not yet been returned. Please raise your hand if you have a proxy. The inspector of elections designee, Heather Raines, our Chief Financial Officer and a Provectus shareholder will come around and pick it up. Any stockholders present today who have signed and submitted proxies for the meeting do not need to vote today. Your shares will be voted in accordance with your instructions on your proxy card. Now please raise your hand if you did not receive a proxy or if you received a proxy and returned it but now want to change your vote or if you received a proxy but did not fill it out and now intend to vote at the meeting. If you fit any of these descriptions, please let the inspector of election know you would like a ballot. Please mark the ballot as the stockholder votes are taken. If you choose to vote in person, it will be necessary for you to prove your ownership of the company's common stock as of the record date of April 21, 2025. Stockholders may submit their ballots until the final call for ballots is made. I will report the outcome of the vote on each proposal after all the votes have been tallied at the end of this meeting. We have 5 items on the agenda this afternoon: to elect 4 directors to serve on our Board for a 1-year term; to conduct an advisory vote to approve the compensation of our named executive officers; to ratify the selection of CBIZ CPAs P.C. as our independent registered public accounting firm for 2025; to authorize our Board to amend our Certificate of Incorporation as amended by the Certificates of Designation to effect a reverse stock split of our common stock, Series D convertible preferred stock and Series D-1 convertible preferred stock at a ratio between 1-for-10 and 1-for-50, where the ratio would be determined by our Board at its discretion and to make corresponding amendments to the Certificates of Designation to provide for the proportional adjustment of certain terms upon a reverse stock split; and finally, to authorize our Board, if and only if proposal #4 is approved, to amend our Certificate of Incorporation, as amended by the Certificates of Designation, to decrease the number of authorized shares of our common stock and our preferred stocks by the same reverse stock split ratio determined by our Board. We'll now conclude the stock -- we'll now conduct the stockholder votes on these matters during the formal portion of the meeting. After the stockholder voting is completed, we will adjourn the meeting and provide a -- we'll provide a question-and-answer panel session that will follow the company update presentation. We'll now proceed with the formal portion of the annual meeting. The first item of business today is the election of the members of the Board who will serve until the 2026 Annual Meeting. The Board has nominated Webster Bailey, Dr. Lacey, Ed Pershing and Dominic Rodrigues to serve a 1-year term as directors of the company. The floor is now open for discussion regarding this proposal.

Mr. Chairman, my name is Ed Pershing. I'm a Provectus stockholder, and I move to end discussion and proceed with the vote for the first item of business.

You've heard the motion. Is there a second?

Mr. Chairman, my name is Webster Bailey, and I'm a Provectus stockholder, and I second the motion.

You've heard the motion to end discussion of the first item of business. All those in favor, say aye. [Voting]

Aye.

Aye.

All those opposed, say no. [Voting]

The motion is carried. Stockholders are entitled to one vote for each common share registered, one vote for each Series D preferred share registered and 10 votes for each Series D-1 preferred share registered. If you are voting by ballot, please mark your ballot and hold on to it for now. Are there any other questions with respect to the voting on the first item of business? The second item of business today is the proposal to conduct an advisory vote to approve the compensation of our named executive officers. The floor is now open for discussion of this proposal.

Mr. Chairman, my name is Ed Pershing. I'm a Provectus stockholder, and I move to end discussion and proceed with the vote on the second item of business.

You've heard the motion. Is there a second?

Mr. Chairman, my name is Webster Bailey, and I'm a Provectus stockholder. I second the motion.

You've heard the motion to end the discussion of the second item. All those in favor, say aye. [Voting]

Aye.

Aye.

All those opposed, say no. [Voting]

The motion is carried. Stockholders are entitled to one vote for each common share registered, one vote for each Series D preferred share registered and 10 votes for each Series D-1 preferred share registered. Are there any other questions with respect to the voting on this second item? Third item of business today is the proposal to ratify the selection of Marcum LLP as our independent registered public accounting firm for 2025.

CBIZ.

Sorry, CBIZ. Sorry, CBIZ. Thank you. The floor is now open for discussion regarding this proposal.

Mr. Chairman, my name is Ed Pershing. I'm a Provectus stockholder, and I move to end discussion and proceed with the vote on the third item of business.

You've heard the motion. Is there a second?

Mr. Chairman, my name is Webster Bailey. I'm a Provectus stockholder. I second the motion.

All those -- you've heard the motion to end the discussion on the fourth item -- third item, I should say. All those in favor, say aye. [Voting]

Aye.

Aye.

All those opposed, say no. [Voting]

The motion is carried. The stockholders are entitled to one vote for each common share registered, one vote for each Series D preferred share registered and 10 votes for each Series D-1 preferred share registered. If you're voting by ballot, please mark your ballot and hold on to it for now. Are there any questions with regard to voting on this third item of business? The fourth item of business today is the proposal to authorize our Board to amend our Certificate of Incorporation, as amended by the Certificate of Designations of the Series D and D-1 convertible preferred stocks, to effect a reverse stock split of our common stock and our Series D and D-1 convertible preferred stocks at a ratio of between 1-for-10 and 1-for-50, where the ratio would be determined by our Board at its discretion, and to make corresponding amendments to the Certificates of Designation to provide for the proportional adjustment of certain terms upon a reverse split. The floor is now open for discussion regarding this proposal.

Mr. Chairman, my name is Ed Pershing. I'm a Provectus stockholder, and I move to end discussion and proceed with the vote on the fourth item of business.

You've heard the motion. Is there a second?

Mr. Chairman, my name is Webster Bailey. I'm a Provectus stockholder. I second the motion.

You've heard the motion to end discussion on this fourth item of business. All in favor, say aye. [Voting]

Aye.

Aye.

All those opposed, say no. [Voting]

The motion is carried. Stockholders are entitled to vote for -- are entitled to one vote for each common share registered, one vote for each Series D preferred share registered and 10 votes for each Series D-1 preferred share registered. Are there any questions with respect to this -- to the voting on this fourth item of business? The fifth and final item of business today is the proposal to authorize our Board, if and only if proposal #4, our reverse stock split proposal to amend is approved, to amend our Certificate of Incorporation, as amended by the Certificates of Designation, to decrease the number of authorized shares of common stock and preferred stocks by the same reverse stock split ratio determined by our Board. The floor is now open for discussion regarding this proposal.

Mr. Chairman, my name is Ed Pershing. I'm a Provectus stockholder, and I move to end discussion and proceed with the vote on the fifth item of business.

You've heard the motion, is there a second?

Mr. Chairman, my name is Webster Bailey. I'm a Provectus stockholder, and I second the motion.

You've heard the motion to end the discussion on the fifth item of business. All those in favor, say aye. [Voting]

Aye.

Aye.

All those opposed, say no. [Voting]

The motion is carried. As a reminder, stockholders are entitled to one vote for each common share registered, one vote for each Series D preferred share registered and 10 votes for each Series D-1 preferred share registered. Are there any questions with respect to voting on this fifth and final item of business? Is there any other business to come before the annual meeting? I'll now ask the inspector of election, Ed Pershing, to summarize his report of the stockholder votes. The Chairman recognizes Mr. Pershing.

With respect to the first proposal of the election of 4 directors to serve on Provectus Board of Directors for a term expiring at the 2026 Annual Meeting of Stockholders, the results of the stockholder voting are that all 4 received a plurality of the votes cast. With respect to the remaining 4 proposals, the results of stockholder voting are that all proposals were approved with the required votes.

Thank you, Ed. The inspector of election will furnish the meeting secretary with a written report of the final vote count with respect to the matters voted on today, which will be included in the annual meeting minutes. We've concluded the activities and business of the formal portion of the annual meeting. Before adjourning and moving on to the company update portion and the Q&A panel, I want to express to all our stockholders our sincere appreciation of all of the directors, officers, employees, consultants and vendor partners of Provectus Biopharmaceuticals, for your active participation in the stockholder voting process and for your support of our business direction and management. Your continued interest in Provectus is very much welcomed and deeply, deeply appreciated. If there is no further business to come before this meeting, I ask for a motion for adjournment.

Mr. Chairman, my name is Ed Pershing. I'm a Provectus stockholder, and I move to adjourn the annual meeting.

Mr. Chairman, my name is Webster Bailey, and I am a Provectus stockholder, and I second the motion.

You've heard the motion to adjourn the meeting. All those in favor, say aye. [Voting]

Aye.

Aye.

All those opposed, say no. [Voting]

The motion is carried. The 2025 Annual Meeting is adjourned. Thank you, everyone. We'll begin the company update portion of the meeting in a few minutes. Alyssa, can you hear me now?

Yes. You sound good.

Okay. I'll do my best to prevent the feedback. Okay. All right. Alyssa, next slide, please. Thank you. Well, welcome, everybody. This is, for us, the most exciting portion of the meeting. Hopefully, we'll go into as much detail as we can and that meets your expectations about what's going on with the company and the various programs. So more than meets the eye. What we've discovered through our work at Provectus is this. Provectus' Rose Bengal Sodium, which will short form to RBS through the conversation, is far more than a molecule. We believe it's a systems disruptor, not merely intervening in a single molecular target or a linear disease pathway but instead potentially having the capacity to reprogram, rebalance or modulate multiple interacting body systems. We believe RBS is unlike any conventional molecule, API, drug or medical treatment. RBS appears capable of acting simultaneously or sequentially across multiple biological pathways, multiple tissues and multiple disease mechanisms, acknowledging the human body as an interconnected adaptive system. When administered at sufficient exposure, when given -- when enough drug is given to a patient, RBS appears to have the potential to fundamentally reorient, reshape a patient's disease trajectory. We're seeing this potentially manifest itself across multiple therapeutic areas. We didn't invent RBS' medical properties, but we saw what others didn't. From the outside looking in, we saw promise. Now from the inside looking out, we see transformative potential in health care. Our work at Provectus informs how we think about the company's true worth. Our guiding principle, the golden rule, directs how we address patients and shareholders alike and leads our business strategy, which is to deliver safe, effective, affordable and accessible medicines at scale. Next slide, Alyssa. The RBS molecule, a molecule that doesn't fit the mold. RBS doesn't fit pharma's traditional drug development model of one drug, one target, one disease. We believe RBS activates and redirects the body zone systems, immune, metabolic, microbial, structural, et cetera, towards restoring health. Rather than narrowly targeting a system, locking a single receptor, we're focusing in on just one thing, RBS may potentially reprogram how the body confronts disease. Next slide, Alyssa. So what we have for the intratumoral program for PV-10 are 2 co-lead indications: penile squamous cell carcinoma. The historical foundation of approaching this disease lies in the company's historical work and specifically in in-transit melanoma that represented the vast bulk or majority of the patients that were treated by intratumoral PV-10. In penile squamous cell, we're targeting cancer indication in a therapeutic setting, preoperative treatment where local control, quality of life such as tissue preservation matter most and systemic immune response helps. In-transit melanoma taught us that PV-10 has powerful local treatment effects and activity demonstrated by Provectus and recognized by FDA, an intriguing systemic immunotherapeutic potential. When it comes to industry feedback and big pharma engagement, after we took control of Provectus and looked for the first time in the company's history to engage big pharma directly through their traditional channels of search and evaluation of external candidates that they may want to partner with or co-develop, Merck and Bristol-Myers engaged us under CDA, confidential disclosure agreement. Interest in the science and the clinical data were strong, but pharma questions were consistent. Is RBS proprietary? How does PV-10 compare to commercial Rose Bengal in a clinical setting? A misnomer, a misdirection, a misstatement to be polite because you cannot give in a clinical trial setting for a company trying to advance a drug for FDA approval, giving commercial off-the-shelf Rose Bengal. We work with what we have. Early protocols didn't always deliver enough drug or measure the right endpoints. Over time, we learned about intratumoral PV-10 from big pharma engagement. Response data, which we had a considerable amount, are important. But survival data matter more. And as a result, we continued ongoing studies in order to collect survival data to share with pharma, but more importantly, to give us confidence in what we knew was there but wanted to approve. You give enough drug, you can elongate people's survival. Ultimately, for intratumoral PV-10 in cancer, big pharma wanted randomized Phase III data. And we get that. But a question of choice of which disease program, which oncology indication to pursue in a Phase III randomized controlled trial, we need to come out the other side of that study if we are successful with a market capitalization -- capital structure that is accretive, that makes value for shareholders not simply to run the study to present the company to big pharma because we've run out of gas despite a positive outcome. Let's talk about our regulatory experience in Australia and with the TGA, the Therapeutic Goods Administration. In Australia, we had strong clinical support for in-transit melanoma as a differentiated disease. When you look back at the history of the company, the reason why the vast majority of the melanoma data were in-transit melanoma patients, a form of Stage III non-metastatic disease, was because the Australian principal investigators that made up the bulk of the clinical investigators working on trials were focused on how do we solve that specific problem. Unfortunately, the TGA did not classify in-transit melanoma as rare even though it is acknowledged -- even though it is considered by clinicians to be a rare disease, a clinically distinguishable subset of melanoma. Nevertheless, TGA acknowledged PV-10's broad potential in their communication to us. World-class clinicians advocated on behalf of PV-10. Still, regulatory complexity with TGA created obstacles. We worked with what we've had. We took the existing data, seeing if there was a regulatory opportunity in one of the core markets for PV-10, where, again, a vast bulk of the patients were treated in Australia. So as it relates to, again, this single-agent study of PV-10 for penile squamous cell, single-agent study of PV-10 in this setting maximizes the agent's intrinsic advantages: rapid local response, tissue preservation presurgery and immunologic activation. A 6 to 9-patient Phase I study for safety, tolerability and for response will be what we will be carrying out, which will include measuring response by RECIST, but more importantly, by photographs. So we can adequately document pre and post treatment what is going on with the tumors in that organ. The study contemplates enough treatment. The study design will allow for an off-ramp for patients that have a response to receive additional treatment under the discretion of the principal investigators of the study prior to making any decisions with the patient regarding possible surgery. The study is set up at Moffitt Cancer Center with our CRO. And regulatory clearance is in motion, and we'll announce when the first patient is treated. What is important about this study as well is that success with penile squamous cell strengthens intratumoral PV-10's treatment rationale for a number of key disease areas where tissue preservation is key: head and neck squamous cell, preoperative breast cancer and several more. And these are where intratumoral PV-10 deserves to be. Finally, here with metastatic pancreatic ductal adenocarcinoma. Yes, we've discussed this study since 2018, driven by a highly engaged principal investigator and sound clinical rationale. But our question is how can -- what clinical trial protocol can enable PV-10 to meaningfully alter an mPDAC's patient's disease trajectory. We've joked in a serious way that a little PV-10 goes a long way. Enough might cure you, not an FDA claim. But it's that idea of what protocol facilitates giving enough drug to the patient to alter their outcome. The answer is emerging, but it's taken time to frame the data and dosing model in a way that FDA can evaluate. Again, when we're ready to commence that trial, we will let shareholders and the market know. Next slide, please, Alyssa. We conducted an AI-assisted analysis of all cancer papers on the main biomedical literature database PubMed from 1958 to 2025. Why did we use AI? Because RBS is complex, mechanistically and clinically. AI enables scalable, reproducible synthesis across disciplines, linking immunology, cell biology, oncology and more. We all take or should take AI with a grain of salt, but it is a tool that can help us go through, and did, 457 abstracts of papers or papers themselves that were available under open access from 1958 to 2025, whether those were produced by Provectus, a Provectus-affiliated researcher or an unaffiliated researcher, many of whom were doing research in parallel and/or before Provectus and Moffitt Cancer Center. What was our hypothesis? That RBS may act as a systems-level reprogrammer, that it would undertake disease treatment of multi-target, multi-pathway, multi-context situation. AI helped us to test this hypothesis with rigor and reproducibility. So again, we reviewed 457 papers. We evaluated quality, quantity, consistency of evidence. We cross-validated across tumor types, delivery routes, research disciplines, looking for contradictions in those papers because clearly, it would make sense to all of us that someone, some people somewhere around the world, one or more of those papers would contradict another. And so we asked AI, pretty please, for a confidence level, not a p-value, so we're not equating it to statistics -- to biostatistics or statistics, but a judgment weighted probability. Our confidence, very high. All of the evidence aligns with, frankly, no contradictions to the idea that RBS is multi-targeting, multi-pathways, multi-context. So in conclusion, RBS is best understood not as a traditional drug but as a biological reprogrammer that may potentially activate both death and defense in tumor setting -- in the tumor setting. The molecule may trigger intrinsic immunologically meaningful cell death while potentially awakening systemic immune machinery. Its potential versatility, safety and reproducibility across models and modalities offer evidence for its potential widespread use for the oral treatment of solid tumor and blood cancer. Alyssa, next slide, please. VisiRose, that is our spin-off company founded entity for ophthalmology. Regulatory prep is ongoing. We have to collect data from Bascom Palmer in terms of their preclinical work to establish the treatment. As a reminder, Rose Bengal or PV-305, dropped into the eye, activated by green light as well as nearly 10 years of data, approximately 136 patients that have been treated at Bascom Palmer by -- at no charge to the patient in order to help them when they come in with an eye infection that has failed standard of treatments where the outcome would be, without any further treatment, the loss of sight. We've had to work with the Stanford University and the University of California San Francisco to access the data that was generated in the India trial for fungal and parasitic keratitis to be able to get that data and not the data by cutting and pasting data tables in a paper but understanding the underlying data, the raw Excel spreadsheet, so to speak, and to be able to communicate to FDA how the data was collected, that it met good practice. The likely target label will be first-line treatment of fusarium fungal keratitis, the most common fungal eye infection there is. And interesting statement by the lead Indian principal investigator, which is also a little bit quizzical, is the next patient he sees with fungal keratitis of a fusarium fungal strain, he would use Rose Bengal photodynamic antimicrobial therapy. Alyssa, could you move back up one slide? One more, please. Yes. Thank you. And so he's recommending a treatment where neither the device nor the associated drug is approved but believes that, that is the right, appropriate treatment than using standard of care, which would be an antimicrobial. In PH-10, our clinical stage dermatology drug, our researchers are still completing their work waiting on a large animal study. They've done the RNA sequencing in the first batch. They're looking to get -- because of the difficulty of running a large animal study in New York City. This work is taking place in the Rockefeller University. They're waiting for skin biopsies from the large animal study being run by our research collaborators for wound healing. That collaboration -- because they are essentially working in the same space, that data can be transferred to them in New York in order for them to round out the analysis. The earlier understanding about the concentrations of PV-10 10% RBS or PH-10 0.01% RBS or PV-305 0.1% Rose Bengal Sodium were misunderstood by essentially everyone. Recall that I opened by noting that while we didn't invent RBS' medical properties, we saw what others didn't. PH-10 shows impressive specific and broad spectrum up and down regulation of multiple key pathways in a nonclinical setting. So the research generated to date is remarkable in terms of how many genes are up and down regulated and the proportions of up versus down. And we simply need to have that data rounded out before we can understand how to proceed with monetizing that asset. Our research collaborators in wound healing, the University of Texas Medical Branch in Galveston, are wrapping up their large animal study, and data are expected soon. As it relates to oral PV-10, starting out with giving oral PV-10 in solid tumor cancer setting, we're finalizing preclinical research plans with new research collaborators, work that is funded by a shareholder, which -- we'll discuss his story a little bit later today. Based off of clinician feedback, we plan to explore intrabladder or intravascular administration catheter into the bladder of PV-10 alone as well as oral PV-10 and in combination with PD-1 for the treatment of bladder cancer. We also plan to expand PV-10's IND, the regulatory vehicle that allows us to administer the drug to people, to, among other things, include oral administration. We deeply believe oral PV-10 may be game-changing for cancer and a host of other diseases. And then finally, for proprietary targets, we are actively pursuing nonclinical research to gain mechanistic insights for a pivotal cluster of diseases, and we look forward to revealing that research when it's completed. Next slide, Alyssa. So in conclusion, we believe that RBS can build or develop systems-aware medicines. It's not a label. We're not here to create labels, to relabel, rebrand RBS. We're trying to simply use some terminology to help you understand what we feel the molecule is capable of. What is a systems-aware medicine? It's a treatment built for complexity. The treatment itself isn't complex. It's a simple small molecule. But that medicine, that treatment built for complexity doesn't intervene at a single node but across the biological network of the body. RBS, again, as a reminder, may simultaneously or sequentially, across immune, metabolic, structural and microbial systems, help the body. What is the total addressable market for a drug or a platform like this? We don't typically put total addressable markets into our presentations. We've gone through versions of them, of course, and you've seen those investor presentations. And sure, we did that. We're not here to cough up what we -- what the total market is as a way to hype it or promote it. We're trying to give you an understanding of what we feel with further development is the total addressable market for this molecule. And so we think some amount of Rose Bengal Sodium can support, be involved in, be part of the treatment of most diseases. So just saying, the total addressable market for RBS, we believe, not promoting, not hyping, is everyone on earth. We're not building a new drug -- we're not just building a new drug. We're building a new kind of medicine, one that recognizes the whole system, the whole body, one that may treat disease by restoring balance, not just attacking systems -- symptoms. So thank you for being part of this journey. Next slide, Alyssa. So some of the achievements, patents, publications this year since the last annual meeting. We also were informed of another paper that is planning to be published. And so we expect 3 papers to be published probably in the next few months to a few weeks. And now I think we'll turn it over to Ed and the rest of the Board of Directors to enter the Q&A panel.

This year, I'll keep my comments short and to the point. Much has been accomplished that as we've advanced the understanding and the potential applications of this drug, it's been a remarkable year. We, on a number of occasions recently, commented to people that we'll be studying this drug long after I leave this earth because of the complexity of what it's able to do. I personally believe it is a drug for a time such as this. If you look at what's going on around the world in health care and the rising incidence of disease, let's choose cancer. If you want a quick study, just look at what the social health care systems in Europe are encountering as they see rising incidence of cancer. What's one form of cancer that has one of the highest rise in incidence rates compared to its baseline? Pancreatic cancer. What is the common term you're hearing? You don't hear it in the American press that often. If you go and look in foreign countries, what's the common term, quoting oncologists around the world? Turbo cancers. Numerous patients being -- appearing for their first examination and learning they have Stage IV metastatic cancer, growing rapidly. Kids appearing with forms of solid tumor cancer that oncologists have said in their careers they've not seen occur until now. And so I personally believe, and I believe this with every cell in my body, this is a drug for a time such as this. We're learning more and more about what it can do, and you can do it safely with minimal side effects. And with that, we intend to pursue this to where we can reach everyone in the -- of this type of medicine. And that's what we're committed to striving for. And with that, I think that gives you plenty to contemplate. I know everyone's always anxious to ask questions. We look forward to it. And so with that, I'll -- and I do want to thank Dominic for covering for me today so I can preserve my voice because I enjoy this part of the interaction. So as hosting goes, bring it on. With that, we'll start first with those in attendance here in the room, and then we'll be sure to recognize those who are participating virtually.

Alyssa, we'll try to repeat the question that's asked so that the folks online can hear it.

Excellent. Thank you.

So if you raise your hand.

[indiscernible]

So the question is, in the past, we've talked about starting a trial for breast cancer, where would that be in our plans?

And before I'll make an editorial comment, so that anyone participating today can understand, that question came with my co-founder at PY. We've known each other since 1977, 1976. And so he knows part of my passion for this. And so I could say it's almost like a setup question. But it really is a question.

It's not a setup.

I can tell you fundamentally from the first time in the fall of 2005, when I learned about this drug and this molecule, I started on the search to learn everything I could about it, everything I could from anywhere. And those were in the days before you can quickly Google something and find it like that. And my real passion for this, what engaged me most and what has befuddled me by the prior actions of prior management is why they didn't pursue breast cancer. That would have been probably #1 in my book. I'll give you another observation, and then I'll come back directly to answer your question. If you didn't choose that first with their first work, why they didn't go after metastatic disease to the liver? I'll never understand. I can quote you the first 5 patients. I can quote you the next 8. You want to know their average age, how many average treatment received, why you go into the [indiscernible], which is extraordinarily expensive and takes years. And so one of the things I think we bounced around in decisions, and feel free to believe that, but I promise you, you have no idea, all the variables that have gone into the decision making. It's not one. It's not 10. In some cases, I mean, it's almost enumerable. Breast cancer is still my driving passion. I personally believe it will transform breast cancer. I find it remarkable and quite coincidental that I think the trial that will be the trial to be recognized in my opinion, I think, gives us the best chance of success is penile cancer. Well, that exposes 48.5% of the population. And so if we're successful there -- the attributes of that, limited tissue for margins, surgery is not an effective treatment. It's devastating. It's devastating. That's why they remove the penis. And so if we can address that, that opens up market of head and neck, all those areas of the body in which you have limited tissue. Functionality is critical. And so being able to show what this drug does and the fact that it not only limits itself to destroying the disease, it then engages the immune system to heal that area, to me, this study is designed -- this disease is perfect for PV-10 because it won't take many patients. The trial size will be small. Unlike pancreatic cancer, you're not looking at survival. You're looking at whether there's surgery done in 30 days or 60 days or 90 days or maybe it's going to be never because you save that organ. And that trial design is going to be quite small. The period of the study will be quite short compared to any other form of trial we would be doing. And suddenly, you put this drug in the company on the map. And so -- and that leads in a great transition then at some point when we have the adequate funds to pursue breast cancer. It's still my passion, I'll just tell you, because you want to talk about an industrial enterprise, that's the breast cancer industry. And when you consider how many women are exposed to the most toxic chemotherapies to this day and the strongest dosage of radiation you can safely administer, particularly for some forms of breast cancer, triple-negative being right at the top, I'll take way to take on that challenge. So we still -- it's a question of timing, Doug.

And Ed, to be clear, and the question for the online audience, we're talking around breast cancer and is it in our development plan and when, is to be clear, the company did do a very small breast cancer study in New Zealand. But unfortunately, the tumor was excised before you could give PV-10 the chance to perform. And so why would you undertake certainly a melanoma study? We get the idea that before the advent of the immunotherapies, melanoma was the graveyard for many drugs. And if you survive, if you beat melanoma someway, somehow, that added significant validation to your drug or drug platform. But if you were evaluating and if you truly believe and knew the strengths of your drug, you would have not melanoma. You would have chosen breast cancer, or in this case, you would choose penile cancer because you're looking for quick, rapid complete response of the lesions or the tumors you're injecting. You're looking to preserve tissue, and you're looking for that immunologic activation at the downstream lymph nodes so that whole argument supports certainly the delay or perhaps mitigation of surgery until such time if ever there is a need because the cancer has spread or come back. And so the reason we chose to push penile as we're evaluating what study can we do, and as Ed said, there's an opportunity to see results quicker, survival isn't the question in this preoperative setting. It's can we push off surgery. And that's why we think it's an important co-lead indication to be able to validate PV-10. It's a rare disease. There's 2,000 men each year that get penile squamous cell. The 2 main medical centers in the U.S. that treat those patients are MD Anderson and Moffitt Cancer Center. And we have very motivated, very passionate principal investigators, one surgical oncologist, one medical oncologist at Moffitt that would like to undertake this study.

And this is a great question, Doug. In response, just to open the door a little bit about history because thankfully, we know so much of the history about this and the mistakes that were made. And let me give you an example of breast cancer. One of the patients [indiscernible] is a patient treated on a major institution, world-renowned institution in which management did not work to define the trial well. And so when a woman ended up urinating [indiscernible] urine, the surgeon immediately thought there was internal bleeding instead of understanding what this drug is all about and did a mastectomy and all the potential data. We had no information about how the tumor was responding in that patient. Acknowledge, when we sit down to discuss with Moffitt, we've been emphatic about making sure you keep the scalpel in your drawer as long as you can. Give the drug a chance. We now have a lot of data about how reactively patients respond, some of the variability of that. We understand the importance. If you look at the 4 uveal melanoma patients I keep [indiscernible] in the top left-hand side of my desk, in the top drawer, 4 patients are alive today. Three of them are alive solely because we modified the trial when we got control to say use sufficient suppression to do an additional injection if the patient is responding. Two of those patients got second dose, and then one got a third dose. And one of those patients [indiscernible]. That patient would not be alive today if she hadn't received a third dose. So in essence, 3 out of 4 would not survive had we not stepped in and modified the trial. And so that trial emphasized capturing every piece of data. We've had impassioned discussions with Moffitt about the importance of giving this drug a chance, and we've emphasized something as simple as taking pictures beforehand, during and after.

And we'd like to work in a question online, where a shareholder asks, how is penile squamous cell different from uveal, recalling or saying, putting words in our mouth that we said uveal was the Holy Grail of our approach or to get recognition for PV-10? And so what's different this time? Great question. Absolutely. What you saw with the balance of the uveal melanoma patients, again, remember, so these are the hepatic tumors, uveal melanoma that has gone metastatic to the liver. The vast bulk of patients treated by Provectus before Ed and I joined the company received one injection to one tumor on the liver, period. Now some very interesting data, and we mentioned this at the last shareholder meeting. 70- to 80-year old man who received one injection to one pancreatic tumor -- pancreatic cancer tumor metastatic to the liver, declined to take chemo, received PV-10 to 1 of those 2 tumors that he had on the liver from the pancreas, lived for 30 months before he passed away. So while -- and what we were able to show, and there's 2 aspects, and Ed's already raised it. First is give enough drug. But second, setting aside that you've got the right endpoints, how do you prove that you have defeated the cancer? Company history where the discussion of before and after photos for melanoma was a regulatory discussion. For uveal melanoma, we insisted upon PET CTs to show what -- or how patients' disease were progressing. If you go back into the literature that we have shown, proven, distributed, those 4 patients Ed's referencing achieved complete metabolic response. Typically unheard of when you're trying to evaluate is there any disease that is active in the body. And so we didn't use the Holy Grail. We never use that word out loud to be respectful of patients and shareholders. But it certainly was the priority that looks like this is the right way to go, but the challenge would be using a survival endpoint makes it a longer measurement period even if you were to take a PET scan after 6 months, 24 weeks, which is what is built in into the pediatric -- sorry, the pancreatic cancer study. In 24 weeks and 6 months, we would take that patient's first PET scan with the hope of significantly reduced compared to a baseline PET CT or no disease. But penile offers the opportunity because that patient is going to be scheduled for surgery as they roll into the trial in 4 weeks. If -- and the study design contemplates an off-ramp for that patient if they respond to the initial injection of PV-10 into one or more of their penile tumors to receive more treatment, which would mean, under the patient -- under the physician's discretion, with patient consent to push off the surgery, which is penectomy, which is amputation, to see if that -- they -- we can continue to push that disease off. So what's different this time? We're using all of the strengths of PV-10: quick, rapid, complete treatment, tissue preservation, immunologic activation of the downstream lymph nodes and hopefully a better perspective to show PV-10 in a pathway where, again, the comparator is surgery. And it's unlikely the FDA would require a randomized control arm where you're comparing PV-10 versus surgery. So we think that there are key authentic differences, and pancreatic is meant to be ahead of uveal simply because that's a really bad disease, and we think we can beat that, and again, look at different ways to validate PV-10. But that's what's different compared to between uveal and penile.

And I'll make one more comment. That's a great question, tying back to uveal. There's some things on this journey you don't control. And the lead person at MD Anderson is so -- strongly believes in this drug for uveal melanoma, got recruited to another institution. Just personal observation, not attributing to that physician whatsoever. But over the course of the [indiscernible] sessions, understanding the outlook at that renowned institution and the fact 2 older [indiscernible] oncologist asking, why would you be looking for Stage III patients? We just do Stage IV. Well, how you will give the patient the best chance is address Stage III, try to treat at Stage III. And so I know it's a long answer, but it kind of gives you some perspective on the many variables that go into when we choose the best path. And so we're trying to get us to a big win as quickly as possible. Other questions in the room?

[indiscernible]

So the question in the room was, did Ed get a call his -- Secretary RFK -- R.F. Kennedy called yet?

Let me -- if I don't answer your question -- I haven't gotten a call yet. That's not a complete answer. It's a great -- I have something on my desk [indiscernible].

[indiscernible]

So the question -- follow-up question by the same shareholder was, do we see -- does Ed see any difference in regulatory ease or approaches to drug development from the new administration and the new head of FDA?

If you look at today's addition of endpoints, that's a daily -- we get a morning, an afternoon and an evening alert on developments in drug, approvals, mergers, whatever, shutdowns, whatever. It's a great way to keep alert. You'll see the lead article today is the new leadership of FDA [indiscernible] looking for a way to get promising drugs approved in very short periods of time. It even mentioned, I think, in the headlines 2 months. In the headlines 2 months?

One month.

One month. Later on, if you look in the Wall Street Journal, it's got a similar report. It's got a similar article in today's Wall Street Journal. In today's world, you have to be -- I can't go to my human nature of growing up in [ Black County ] to say what I want to say. So this is a public company comment. The change environment that is occurring right now from a regulatory standpoint, it's fundamentally different from what we see today. And I'll just make one observation. If you don't believe that [indiscernible] person in a key position [indiscernible] went to once they left when RFK was announced. That's all you need to do. I'll rank them as departments where they went and the common denominator [indiscernible], and it's where they came from. So fundamentally, and one of the key decision makers when I started this journey, I really felt this is a personal statement. I really felt I knew how to navigate major federal institutions. [indiscernible] being challenged all the way up to [indiscernible] other organizations. I've never been in the FDA relative to drug approval, but I was very familiar with it on some other things. I thought there's a way to navigate this. There's always a strategy. It has changed over the last 10 years. And you look at where they came from and where they went to and how much they're being paid now [indiscernible] position with Pfizer or one of the others. And today, it's a whole new game. And I personally believe we can -- my goal, I'll just say my personal goal, and I know Dominic shares this. It's to put together a package where we can walk in and say we have what you're looking for to validate a new approach to drug approvals: safety, efficacy, ease of administration, ease of distribution. [indiscernible] 15 years ago, I think I was 15 [indiscernible]. I think they came in being about a dozen years ago or 10 years ago. So this is the ideal time for us to be navigating, I believe, the regulatory process here and elsewhere.

[indiscernible]

Well, let's talk about -- I think I shared this a few years ago, and this is an example to learn from. And so I can say this now. This is my personal opinion. If you'll recall, we shared with you when we were studying [indiscernible] with Dr. Krueger at Rockefeller [indiscernible] first major initiative was started, was to find out -- there was so little known about how this works with the immune system. It's [indiscernible] 16 years how little was known about how it works with the immune system. huge [indiscernible]. That led our exploration about its antiviral capabilities. If you remember when COVID broke out, I literally had, I'll just call it, connections. People would walk me in the -- and they literal said, if you don't believe us, you name them, and that's where we'll take you, if you can take on COVID. And we had [indiscernible] on it before anybody did. Oak Ridge National Laboratory did a computer model, and their scoring was very close. And the person in Canada said, this is great because how you bind and where you bind, this bar is going to be -- is probably -- I quote, it's probably already different in New York than it is in Canada. So the way you bind. And everybody -- that person just asked me 2 weeks ago to repeat for his wife why we didn't go. And I said, we'll have to be bulletproof because what you're going up against -- and I rest my case on that judgment call because if you saw what they did to ivermectin, the only drug to ever win the Nobel Prize in Medicine. I can take you back to [indiscernible] when it was -- when they pursued it -- when Merck pursued it for treating river blindness in Africa, when there was no payable market versus today. So I just want to stress and round up, they are variables you cannot control, and we've encountered a number of those. And a lot of those variables now [indiscernible] really impact us more than shareholders will ever understand.

And to be clear, we want to be bulletproof. What does that mean when we undertake a clinical trial? Bulletproof down the middle of the fairway, pick your analogy. We will measure -- for example, with the mPDAC study, we'll measure response by RECIST the gold standard for how you measure the response of a treatment -- the tumor response to treatment. But we also plan to use PERCIST, which is using a PET CT to evaluate tumor activity. We'll use RECIST with FDA to show what the response is and certainly progression-free survival and then overall survival as we move into a pivotal trial. But we also want to show PERCIST, that PET CT scan after 24 months because we think -- and it's not enough numbers of patients who are treated successfully in uveal melanoma where -- can we determine a surrogate endpoint for overall survival? Well, we want to build the case through data that if the patient achieves a metabolic complete response, a complete metabolic response that, that could be prognostic for survival. So we're not simply going to just have what the industry typically does in the clinical trial. We want to collect extra data to make sure that we have a fulsome set of data to make a thoughtful argument to FDA as to what the data of that trial should be.

If I can make one observation. I'll just share one story about a variable because it's something I did not understand when I started this journey, and it still defies all logic. I just shared this story today. This company was criticized, prior management, I think, unjustifiably. There's things they could have done to avoid it, but they use PERCIST on one of their trials.

No, modified PERCIST.

Modified PERCIST, that's right, rather than RECIST. And they were criticized for it. In fact, there were bloggers and one author of a [ RAG ] with a lot of input really doubted their outcome. Now let me explain to you because the first time I started -- and realizing what this really represented, it tells you how flawed some things are. In RECIST, the standard, what you do is measure the diameter of the tumor at its widest point. I'm just going to use this basic language, measure it. And so -- and then if you -- when you come back and measure it later to see if it actually responded to the medication, you still do the same measurement [indiscernible]. Now let me give you an example of how insane that is. What if the tumors -- a lot of the tumors, I think of one [indiscernible] visualize the tumors. The bulbous tumor, the volume there, you could shrink -- you could destroy 80%, 90% of the volume. But on the [indiscernible], instead of 3-dimensional, it's only 2-dimensional. The diameter is probably not going to change for a period of time for you to shrink. That's an unresponsive lesion or tumor based on that simplistic measurement. Now you want to talk about -- I was infuriated for months. Still I'm infuriated, I think. That's how you measure tumor responses in today's world.

Now the -- now to build on that point, what should the company have done? And by the way, the reference was made by a journalist in an online website of reasonable note. What should the company have done? Because when you modify RECIST, there are 2 ways to look at it, okay? They modified the measurement program to properly adjust to how the treatment they were giving fit -- better fit into that measurement scheme. Or you can take the tack that modification was evil, nefarious. They were trying to cheat. Glass half full, glass half empty. I call the latter lying. And so what could you have done? You could have measured by RECIST and then take before and after photographs so that you could show the volume being deflated, the change in color of the tumor. And so what we're trying to show, and so with penile cancer, it is conceivable that if you followed RECIST, you might not give an additional treatment. So we want the physician to realize, through giving the physicians, giving them -- again, so at a visceral cancer, you can't really tell. And so because the CT scan, by definition, is what RECIST will be based on, you're taking the PERCIST scan to give FDA more information. You're not replacing it. You're giving them more data. But for the superficial tumors, melanoma, penile, you're using photographs to combine with what the physician is seeing as a way to inform them to give them the data, the ammunition to decide in concert with the patients, should we hold off surgery on the penis so that we can give you -- we can let more tumor be destroyed by the drug? Should we give you another shot? Should we give you shots to more tumors? So we're trying very hard to stick to down the middle of the fairway protocol but collect more information simply before and after photos as an example of more information to make sure that the data captured is what is represented in the moment so that we can, again, make it easy for FDA to understand what's going on while following the rules or the guidelines for how clinical trials should be done.

I want to [indiscernible].

[indiscernible]

That's what we've done.

And that's what we've done, Bill, but also want to modify sort of what you said. What exactly did Amgen do in that protocol? They waited for a 6-month period before they assessed response. We know, data show, that PV-10 has a much faster response -- or the tumor has a much faster response to injection by PV-10 than IMLYGIC. So we totally get the 6-month time period. The reason why Moffitt would even consider PV-10 -- intratumoral PV-10 for penile squamous cell is because of the speed with which -- from a clinical data to date, again, no penile tumor injections to date. It's a new organ system for us. But because, again, tumor cells start dying in hours, the immunologic response starts within days. And so it's that ability to have rapid, quick and complete responses. And so yes, we've had to work in the typical protocol for when one of these patients would be scheduled for surgery to maximize treatment within that appropriate period to give the physician, together in consultation with the patient, enough data so that the patient can make an informed decision together with the patient -- with the physician to put off surgery until more treatment can be given, again, to do it -- to give enough time, enough drug, et cetera. But I think the fundamental difference between IMLYGIC, Amgen's intratumoral drug, and PV-10 is simply the speed with which injected tumors respond. And their choice of endpoint, roundly criticized by folks, some fair, some unfair, was simply the fact that their agent wasn't as good from -- in terms of the speed of response of tumor. And we want to make sure that we're appropriate with protocol but also give the patient enough time and enough drug. So great point.

That's another memory, Bill. You're right. But they did get that approved anyway.

[indiscernible]

I'll go so far to say there's one cancer researcher who believes its actual response was due to you poke any tumor 12 to 14 times with a needle, you probably won't get an immune response. It just aggravates it. It's really not the drug. That's how dismissive they were [indiscernible]. We always try to recognize anyone who's got a question, anything. We've had one for David. He's raised his hand. Anyone share a personal story? Dominic, if you will, I'll let you...

So we were made aware of a shareholder who wanted to speak about their health experience. And so we're happy to call the shareholder to the podium. He'll introduce himself and talk about his experience. He made us aware of what he wanted to say. And so to pick on our outside counsel at the end of the table, we want to say a few things in advance, with no judgment to our wonderful outside legal counsel, who we love dearly. The statements and opinions expressed by the shareholder who wishes to speak at this meeting is his personal statement and opinion and are not being made on behalf of Provectus. We also want to say that what he'll share with you is that he took commercial-grade off-the-shelf Rose Bengal under the guidance of a physician. He did not take PV-10. His situation is not dissimilar -- is similar to the experience at Bascom Palmer, who were using commercial-grade or nonpharmaceutical-grade Rose Bengal in order to explore, after extensive research, preclinical research, the use of Rose Bengal together with the green light medical light source in order to treat eye infections. And so we want to make -- and so the patient did not receive PV-10, which is our intratumoral drug. The patient received or took oral PV-10 -- sorry, oral Rose Bengal. So I want to make it clear that we're not making any claims about PV-10, about the programs we're doing, but we thought his experience was quite important for shareholders to hear firsthand. David?

Good afternoon. I want to make sure -- could you guys see me okay in the back? I have a hard time here. So I was introduced to -- So I have a journey, and it's just all about this right here. You guys are family and friends to me. I met Jacob for the first time today. I met Lisa over there for the first time today. Everybody here is all part of the same. We don't stretch the truth or exaggerate. We know this is God's miracle in this bottle right here. So I heard I had Stage IV pancreatic cancer last May. So what is that? 13 months ago and I had bad news. They told me, after they had the scans, that I was not going to be around for about 3 months, maybe 4 months. That's -- it was growing. It was metastatic. It was huge in pancreas, definitely Stage IV by both metastatic and signs. So it was very disheartening. And they said, well, you can take some chemo, give you a few, maybe extra months. That's the protocol. Now this is conventional medicine. Not -- we have the alternative here, the integrated type like medicine. And Bill, you've heard stories like what I'm going to tell you, countless stories. I'm just one another story. And so I started taking this product after David -- I can't say the last name. One of the people -- one of my neighbors introduced this to me. We had a prayer vigil in my neighborhood. They all knew I was on chemo at that time. I had a little, what you want to call it, [indiscernible]. I think that's how you pronounce it. It's the strongest chemo you can take. And if there's one of them you can't take out of 3 at time, you have to take it home and wear around your neck. And it's like a little box you wear with you for like 2.5 more days. And so after being on chemo, then my neighbors got together, would you say half -- I'd say half of the neighborhood. It was this huge. And they all got and prayed, read scripture for me, New Testament, Old Testament. I'm not trying to be political. I'm not trying to be religious. But we know there's something in here that come from above. So my neighbor introduced me to the Rose Bengal, and that was back in August. And so August of last year, then I started taking the actual product. And I took it orally. I don't even know what percent is it here. Do you guys know the percent in this thing I'm taking? Okay. [indiscernible] oral [indiscernible] not work. It was sticky. It was rose color and everything like that. And so we saw 4 different doctors. And only one doctor, the fourth one, gave me a little bit of hope. And he wrote a little picture for me. I can't mention any names. I won't say where it came from. But I know you can't probably see it, but right in this picture right here -- I don't know if it's focused, not focused. Anyway, you have a copy of this. And he said -- yes I'm just going to walk around [indiscernible].

David, you'll have to stay at the podium. There's like 60 people online.

Very confused. It's just a miracle story. I'm jumping around a lot. So I'm going to go back a little bit. So in my neighborhood, we probably have about 50 homes and -- actually 100 homes the more I keep thinking about it. And there were 3 people with pancreatic cancer. One died earlier, but 2 people had it active last year: myself and a lady about my age, a couple of years different. She was only 4 days -- 4 houses away. I don't know how many days she was ahead of me, but she went to that place down in Texas. She didn't use this secret weapon, the miracle. And she went through some clinical trials down that way. My pancreatic cancer was in the body and in the tail. So it wasn't in the head where there's Whipple surgery. So mine was actually in the tail, which is attached to the spleen. My spleen increased in size by about 50%. And my platelets were shrinking, and they were dying. And I almost couldn't get chemo in this. So I went through this product, started in August of last year. And then I had one scan and then started shrinking. Well, before I do, so the fourth doctor -- you have to go see a lot of medical doctors when you have a taste like this because the first 3 basically gave me no hope whatsoever. And would you quit if you had terminal cancer and have 3 to 6 months to live? No, you keep going. Scope the food chain down the 2 chains at the rabbit hole, around the rabbit hole, that kind of stuff. So one doctor wrote this chart for me. And he said, hey, look, what you have, about 32 out of 1,000 will make it through this. But if you do this, I will do surgery on you. Normally, we can and our hospitals do surgery on Stage IV pancreatic cancer. That's an absolute no, no. But if you can do these 3, I think he said, if you can -- actually, my PET scan, which you know what that is, that just shows the actual movement and everything. If you see improvement on that or all of a sudden it's dying, number two, the CT scan is that the tumors are actually shrinking and you get favorable CA 19. That's your tumor marker test. They do a blood test for pancreatic cancer. So that's that a long laundry list. No hope on that one. So bring your prayer and things and everything like that. Then my neighbor came along just after I got this list here. So I got this list around July. This is now August. And he said, I might have a solution for you. And he introduced me to another [indiscernible] doctor working with you guys [indiscernible].

Well, he wasn't working with us.

Doesn't work for you, but he got the product somehow. I don't know [indiscernible].

I think he's aware of the research [indiscernible].

I agree. From the sky. I don't know. I'm not [indiscernible].

Remember that we've said -- long said that Rose Bengal is available from chemical specialty manufacturers, commercial-grade, nonpharmaceutical-grade. There is a version of the molecule made by the original manufacturing process from 1882, and it's available there. Provectus' Rose Bengal is made by a completely different manufacturing process, and we're trying to meet pharmaceutical grade type standards in terms of no impurity profile and high levels of purity that can be demonstrated under chemical analysis.

And they would not ship it to someone that would use it for medical use, personal medical use. It's...

[indiscernible]

I don't remember. I'm not supposed to say it on this thing. I can talk to you offline. Anyway, so it is a miracle though. So I got this miracle. I can't disclose where it is. I know it's called Rose Bengal. That's all we can say. And I met all of these criteria on this list. Unbelievable. I went through 6 months of chemo. And they said, on this here, in order for you to get surgery, you have to get this. And so you have to have a mindset to make sure there's no genetics. I forgot the test. You know what that test is they make for genetics. Then they have the genetics. Then you go through chemotherapy 6 months, and that's that [indiscernible] that came on with all that. Then you go radiation and then surgery. So I got back to them in December. And he goes, oh, my gosh, these results are phenomenal. Every one of these you met. The PET scans, almost no activity whatsoever. The CT scans show shrinkage all way across the board, if not dead. And the CA 19s have just dropped straight down into the teens, which is amazing for CA 19 scores. You don't even have to take radiation. I want to take you right in the surgery. You take me right in the surgery, I had pretty complex surgery. I had 5 organs resected. So my pancreas is #1. You had to take a big chunk of that. That's where host was. The spleen, #2, the whole thing had to come out because it was in there and so messed up. Over here, on the gallbladder, that whole had to come out. That was #3. In my [indiscernible], which is the start of your intestine where it comes up [indiscernible]. That was #4, and they had to clean out [indiscernible] my stomach. It took them all day, before the sun came up, the sun came down. Two surgeons constant, 1 surgeon rotating back, and there's like -- in the operating room, not so many people. Now when I got all done with this, the healing started happening extremely fast. Shocked the heck out of me. I was supposed to get that movement, movement, movement. And I was having no trouble just moving around the hallways. [indiscernible] days, although I have those tubes hanging from me, all those -- they call them the drain tubes. I had 2 of those. One is coming out from the surgery and everything. I don't know if it's called catheterization or whatever it is. And then I had all the staples on my chest because the line that would go in here, they had to go right in and cut it open. It was just regular pancreatic cancer surgery. It's a hole about that big right in here. That's like a Stage II or III. But for mine, because all of the stuff got resected, they had to cut me right in the stomach, right on the rib cage down here. You have seen it. I'll get back over here again. And then I'm back in -- so I drove back home from this place. My wife, she draw me back. That was my dream, my wife would drive me home from this hospital. I couldn't find one in East Tennessee, couldn't find anybody that could do an endoscopy, let alone the laparoscopy, which I got done all within a week after I've gone out the doctors I want to use. And today, this is -- I got my blood test this morning. They take the blood out, got my CA 19 still in the single digits, which is the lowest now. But I drop 1 more point on that. So they call me again [indiscernible] and they looked at all my scans that I just took about a month ago. That was all negative. There's nothing there at all. Of course, there's a lot of things missing down there. And he said, see me again in 3 months. Unbelievable. This is the doctor that was the local oncologist in Knoxville. He's not the surgeon. And he goes, a miracle. And I was talking to my wife. I was so excited. I use ted little tester. My energy level is high. Now my metabolic rate is much younger than I am right now. And I'm just a walking testament of Rose Bengal. Anything else? Any questions?

[indiscernible]

Yes. But I'm afraid there might be one cell they miss and this thing grow so fast. But that's roughly correct.

Yes. Thank you, David. So the statement from the audience was to clarify that David at the podium elected for surgery that the surgery was of necrotic or dead tissue that you also wanted to confirm or make sure that there wasn't a live cell there even though your PET CT showed no activity out of the abundance of caution, but they did excise or remove dead tissue from your pancreas.

Yes. And my biggest concern, to answer to your question, sir, is that I didn't want to have one cell left over. At my age of 70, I don't want to go through what I went through again. I mean that's -- you don't want to do that twice. In fact, I don't have enough organs to go back and do that again. Anything else?

Thank you, David. Again, we want to stress that was not PV-10. This molecule has been around since the 1800s, 1880. I wish I was wall as David. I'm not as tall. With that, we want to recognize questions from those participating virtually.

Yes. So one of the questions was they'd like to hear from the other Board members, the independent Board members, in particular, Dr. Lacey. So Dr. Lacey, Webster, would you make whatever comments you wish to the room and to the online audience?

Yes. This has been -- it continues to be an incredible journey. A lot of the credibleness is really seeing the potential in Rose Bengal. We haven't mentioned it at all today, one of its most fascinating features, and that is that its power to kill cancer cells can be markedly increased by exposing it to ultrasound, x-ray. This means that we can dream of treating cancers with these external modalities, stimulating once Rose Bengal is at its site where it -- within the tumor and get even faster and greater killing power of the tumor cells. Again, that's a feature that I've been particularly interested in, and I think it's going to be particularly powerful as we look down the road. We talked about breast cancer as a huge target, triple-negative breast cancer. I participated in a compassionate use of Rose Bengal early on by participation in the company with an individual who had triple-negative cancer and really had nothing to offer. We didn't save that individual's life, but we did improve the quality of the last days of her life. And so even there, I was impressed with what we were able to achieve on a human basis, relieving suffering and extending, I believe, my personal opinion, extending life to some degree to even an individual who had probably the only Stage V. -- there is really an official designation of such but very advanced cancer who was given no options for help of any kind by anybody. So it's an honor to be part of this effort. It's so great. We appreciate all of our shareholders. I'm a shareholder. But I know it's been a bumpy road for a lot of reasons. And -- but those of us on this Board, I can tell you, have not lost our enthusiasm, our focus or our desire to see this to fruition. Not -- certainly, we want those who invested in this drug to be rewarded for that, well rewarded. But the thing that I think keeps everyone going every day and thinking about this every day, most every hour of every day, pretty much, is the idea that we can help so many people who otherwise would not be able to afford or access what we believe is possible with the drug. But we have to bring it home. We have to meet the challenge. We have to get the approvals and make it real. And there's no -- there's -- nobody's dream about -- dreaming about that only. It's that real and very hard work that we have and will continue to pursue.

I would just add that I think one of the challenges that I think about a lot as we meet and talk and discuss and e-mail is we all want to get really far really fast. But playing in this field is very, very expensive. And so we have to be always aware of how much gas do we have in the tank, and we can start a race, but can we actually finish that race. And so we've talked a lot about going where big pharma is, and we talked a lot about what does it cost to run a trial here and there. And those are -- they're strategic decisions because we feel like we can be effective in a lot of areas, but we don't have enough gas in the tank to start all the race cars and put them all on the track at the same time. So what is going to allow us the opportunity to make big moves quickly, effectively, efficiently and really smartly. So those are the things I think about. And then I think about how -- we have lots of exciting conversations. I'm always the guy that say, I'm an old marketing guy. How do we let the world know? And they're like, we can't yet. There's this thing where we can't say all that we know. And so I'm always asking the communications questions, and I think that we're doing a lot better as a company, communicating more regularly through a variety of forms, and I'm appreciative of that. And I'm just excited to be serving along these guys. I appreciate being on this Board.

Ed, can I run through a few questions?

Sure. Go ahead.

I just also wanted to add to what the -- the Stage V breast cancer patient that Dr. Lacey was referring to. Certainly for intratumoral PV-10, where it can be essentially a scalpel of sorts -- again, we're not making FDA claims. The idea of quick, rapid, complete response of injected lesions. The patient Dr. Lacey refers to was a patient that Provectus did an expanded access program to treat the massive tumors that she had on her chest. And the treatment was able to give her comfort in her last days and made quality of life better despite reticence reservation by the treating physician about whether or not to use the drug. And so could we have wished that we gave her more frequent treatments, gave her enough drug? Of course, we do. But part of what makes [indiscernible] study and the pancreatic study, physicians who understand the value proposition of injecting lesions and the strengths -- the intrinsic strengths of PV-10 is what you're looking for when you're running a trial. For the penile squamous cell, the treating physicians or the physicians at Moffitt believe they can recruit 6 to 9 in the Phase I study, 6 to 9 patients, 6 to 9 months. They think they can do one patient per month. So there are a lot of reasons why, again, from a timing perspective, to generate catalysts. I'm now just going to run through a few questions online. Didn't we have any FDA meetings regarding mPDAC trial and the PV-305 application? Our policy is not to talk about whether we had meetings, et cetera, until the meeting occur. We will have meetings or interaction with FDA to have the PDAC program cleared, the penile squamous cell protocols cleared to submit PV-305 IND for review and acceptance, to have the PV-10 IND, which currently exists, to be expanded to oral. So we expect that those interactions with FDA will come. In terms of catalysts for the next 12 months, those are aspects of catalysts, starting trials or aspects of catalysts, getting preclinical data from dermatology and wound healing. So it gives us direction on how to partner, develop, monetize those assets. Those are among the catalysts that could come in the next 12 months. A question is, how toxic is the drug? Is it flushed out if taken in higher quantities as a preventative measure? We've already said in prior meetings that our University of Calgary research team showed or examined prophylactic application as opposed to therapeutic. Therapeutic, you have the disease. How does PV-10 do prophylactic? Take PV-10 in advance of having disease. Can it push off disease? The company also has done work, put this in our oral Rose Bengal patent applications where in certain mouse models, it can be a prophylactic as much as it can be a therapeutic. So again, building upon the knowledge that we have. In regard to the reverse split, again, as we said at the last meeting and the meeting before that, we want the authority from shareholders. It is not something we're doing just because when it is appropriate because it is a long path to uplist the company. We will -- or after we uplist it, we will do a reverse split if it makes sense, if the Board thinks it makes sense. And certainly, we'll do it just because. And in terms of the work with PV-305 and the University of Miami work for infectious keratitis, again, the first and foremost is to get an IND out there for the treatment. From there, we're able to manufacture a lot of -- a batch of the drug, and we need regulatory vehicles in place in order for us to be able to then talk partnership development, run a study that would benefit from the prior data used by using a commercial-grade version of the drug or the molecule and be able to then generate the data to get approval. So we need that IND in place. Once we have that and we announced it, then we'll be able to provide clear direction based off of interactions with the FDA of what the approval pathway could be. I think [indiscernible] the question.

Unless there's any other questions, I'll close with this. Again, I want to thank everyone. Thank you for your support. I promise you there's -- no one wants to move this any faster than me. I can assure you that. That journey now is soon going to hit 20 years since I first learned about the molecule. My wife reminded me of that just last night. And so I do believe it is a drug for a time such as this. I will make -- I'd use a patient that Dr. Lacey cited. At various times in this journey, there are physicians that have a very nice view of chemicals or intratumoral therapy. I'll remind you, we shared 2 years ago that one of my personal goals -- I've heard about one of the top melanoma specialists in the world making the comment that she dismissed intratumoral therapy in PV-10. I could probably shoot vodka into the tumor and kill it, but I haven't killed the disease. I shared with Dominic that was a personal goal, to change her opinion. In November 2022, on a phone call, she voiced she had changed her opinion and had gone 180 degrees. And so there's those kind of factors. I think often of that patient. The patient was anonymous. Turns out I knew her husband. He reached out to me after she passed and commented on the impact of the drug. We actually modified pretreatment protocol that had previously existed. Patients only got doses separate every 30 days. We modified it when we submitted to the FDA to dose her every 2 weeks. In the first dosing, we only treated on her limbs, because of the massive nature of the tumor on her chest. In the second round, we dosed her chest. She actually became mobile. She had been bedridden. The drug performed just like we expect and told them to watch from day 3, 4, 5. It's going to start changing colors and changing its -- the nature of its firmness. It will start. You'll recognize there's activity there, and that's exactly what happened. I'll sum it up by saying when he sat in my office, he said, I wish she'd gotten it earlier because if she had initially been treated, if they changed her chemotherapy treatment when it returned, and when they made the change in chemotherapies, it exploded. And he said, I wish she got it earlier. I will tell you how she got the drug, how it ended up happening because it's an indication of the bias that sometimes exists in this industry. Her daughter is actually a physician in Chattanooga. And she ultimately called the office and spoke to the office manager, crying and begging, why will you not let my mother try this drug? Because we all know she's going to die. So why not let her try? And that's how the oncologist, the surgeon was pushed to try PV-10. And the outcome of that was the husband would tell you to this day, he wishes she had got it sooner. And he's a scientist. And so that's what keeps us going, knowing we can be transformative in medicine. And believe me, medicine needs a major transformation in this country and around the world. And so again, I believe it's a drug for a time such as this. Again, I cannot thank you all enough.

A couple of things for the online folks. The patient Ed is referencing is the same Stage V, quote/unquote, breast cancer patient that Dr. Lacey was referencing. The melanoma clinician expert who said, well, you can kill any melanoma tumor by injecting vodka into it put her name on a white paper that we -- that experts produced to advocate for why in transit melanoma is a clinically differentiated subset of melanoma to TGA. So she was willing to do that in advocacy of the disease in support of the discussion we're having for them. So I think it's important to kind of appreciate those aspects. And one last thing Ed will presumably close on is part of doing the regulatory work to expand the IND for PV-10, which right now is intratumoral treatment of either superficial tumors, skin, penile, breast as well as hepatic tumors, is to allow for oral delivery. And our plan post getting the IND expanded for PV-10 is to have -- is to allow for oral PV-10 to be given for compassionate use. We're not making -- it's not grandstanding. This is not a marketing play. This is that it, first of all, is a more obvious, more appropriate way to harness the broad strength of the molecule and the drug by expanding the IND to allow for systemic treatment in those cases where we're looking to save lives rather than just preserve tissue. And that's something that we hope will be a catalyst in the next 12 months to let folks know that we can and we're comfortable within the knowledge of the safety profile of the molecule of PV-10 to consider an expanded access program in due course.

Thank you, Dominic. I appreciate that. In fact, the only addition I'll make to that, one of the ways big pharma preserves their position and expands uses of drugs is combination therapies, when immunotherapies first came out and they were claiming this was going to be the cure for cancer, and they discovered it wasn't. And then the next thing was using a combination. First, it was 2 immunotherapies, and in some cases, 3 immunotherapies. If you consider the cost of that, it's staggering. And yet the results are at best incremental, at best. But it sure does sell more drugs. I'll tell you what my dream is. My dream is our combination therapy is intratumoral PV-10 and oral PV-10. And I can't wait to see a patient. I'd love to see that Stage V patient today if we can use intratumoral and oral and so forth. And so that's part of the dream because I'm absolutely certain this is a transformative drug. We just got to execute. There's a lot of hurdles. Believe me, we understand that. There's a lot of hurdles, but I'm confident over time we'll prove that we can succeed at this. With that, I'll close. Thank you again for your support. I'll turn to Nathan just to make sure if there is any matters that we should close on.

No. It's -- you could do adjourn.

Alyssa, we're going to wrap up the meeting. Thank you.

Thank you, everyone. Have a great day.

Thank you for those participating remotely.

Thank you, everybody.

Thank you for being here.