Good afternoon, and thank you for joining us today for our virtual investor CEO Connect segment, featuring CNS Pharmaceuticals. My name is Jenene Thomas. I am CEO of JTC IR, and I will be the moderator for today's event. I am very pleased to be joined by John Climaco. He is Chief Executive Officer of CNS Pharma. Great to have you on, John. Thanks, Jenene. Great to be here. For today's event, we will start with a brief overview of CNSP, followed by a Q&A session to provide the opportunity for each of you to connect with John, hence, the CEO Connect segment. Before we get started, I want to remind our audience that CNS Pharma is publicly listed on NASDAQ and trades under the ticker CNSP. During today's discussion, the company will be making forward-looking statements, and I encourage everyone to view the latest SEC filings on their website at cnspharma.com for the latest information. John, we're gonna dive right in. I'm going to turn it over to you for a high-level overview of CNS Pharma. Great. Thank you. Yeah, so CNSP, again, we trade on NASDAQ under that symbol. We are a drug development company specializing in neuro-oncology. We, as of recently, have two, very exciting programs in this space, both targeting glioblastoma, which is the most primary, most common, primary, and most deadly form of brain cancer. Very difficult to treat cancer, primarily because it lies within, the source of the tumor, lies within the blood-brain barrier. This is this very specialized network of cells that you hear me talk about a lot, that generally speaking, prevents harmful substances from getting into the brain. Unfortunately, you know, an unintended consequence of that design, of course, is that, helpful drugs, helpful substances, like chemotherapy agents, often are prevented from getting into the brain as well. So we have two very exciting drugs, and I think you'll notice a commonality between the two of them. One is berubicin. Of course, we've been working on this for many years. It's the subject of a designed to be pivotal study that will read data next year, and it is a novel anthracycline that was designed specifically to cross the blood-brain barrier, making it the first drug in its class to do so. It also has, thus far, in studies over 250 people, demonstrated no cardiotoxicity, and that is a novel feature of anthracyclines as well. So this study is a large study. It's a multi-center study occurring here in the United States and in Europe. It will read top-line data in recurrent GBM patients in the first half of next year. Again, what we love about this is it's a molecule from a tried-and-true class. This is anthracyclines. They've been around for 70 years in clinical use. Before berubicin, no anthracycline had been shown to cross the blood-brain barrier and actually treat primary or metastatic brain tumors in human beings, and berubicin can do just that, making it a potentially a revolutionary addition to the oncology armamentarium. Now, very recently, we announced the in-licensing of a drug, TPI 287. This is a novel abeotaxane, similar idea, ultimately derived from the taxane family, so another common blockbuster class of chemotherapy drugs, been around for a very long time. Typically, these drugs also do not cross the blood-brain barrier. However, TPI 287 was specifically designed to do that, and once it's inside the brain, it has a completely different mechanism of action from berubicin. berubicin, this is a microtubule inhibitor, so basically, it stops, prevents microtubule dynamics, which is a function of the cell that allows elements of the cell to break apart when the cell divides in half. Obviously, a key component of cell division and replication, which is what tumor cells are doing, that we're trying to inhibit. So this is another drug from a tried-and-true class that has now been modified across the blood-brain barrier. TPI 287 has already been tested in over 300 individuals in a variety of different cancers, including GBM, with some extremely exciting results, 60% overall response rate, 40% progression-free survival at six months, and a 13.4-month median overall survival for these patients, which is just extraordinary because most of these patients, of course, live only four to six months. So we're very excited about bringing TPI into the program alongside berubicin, again, in keeping with our overall philosophy of designing and testing, you know, best-in-class drugs to help these very sick patients who have almost no treatment options today. So that's CNS. Great. Okay, appreciate that overview. So we are going to go to Q&A, and we have had the option for our participants to pre-submit questions. So we have some questions in hand, but for our audience, if you have a question for John, click the Q&A button at the bottom of the screen, type in your question, and we will get to as many as time allows. And John, while we have people looking or thinking of some questions, I know I have a few for you. Sure. So the first one is, can you share with the audience what excites you most about berubicin? What excites me about berubicin is how logical the design process has been. So, you know, it's... I've said many, many times, it's great to work on novel mechanisms of action. It's great to work on really exciting, completely, you know, outside-the-box-thinking products and, and projects, especially for, diseases like this that have nothing. But what excited me was the opportunity to have a tried and true tool do something that those- that tool had never been designed to do before, and that is have an anthracycline cross the blood-brain barrier. So to me, the whole goal here for the company, and how we create shareholder value, and how we change patients' lives, is to get drugs approved. I believe that the fastest way to do that is to start with a class of drugs that's already been approved, that's been approved for seventy years, that has hundreds of millions of doses of experience in clinic behind it, and say, if we could take and preserve the efficacy from that drug class, but get that class to do something that it's never done before, that is cross the blood-brain barrier, wouldn't it stand to reason that that drug would behave in a similar manner once it's inside the brain, as all other anthracyclines do outside the brain? That is, it's a topoisomerase II inhibitor. It's going to reduce the ability of that enzyme to help cells divide, and it's ultimately going to result in apoptosis of these cancer cells. You know, we've seen that for decades on the bench with anthracyclines, but no one could get them to cross the blood-brain barrier. We've done that with berubicin, and so now my belief is that this trial, again, designed to be pivotal, is going to demonstrate to FDA and EMA that we have an anthracycline that performs exactly like lots of other anthracyclines do, does the same thing. It just does it inside the blood-brain barrier on GBM tumors, and that will be a tremendous breakthrough. So I feel like, you know, at its most basic, we're starting with the deck stacked in our favor. We know that this mechanism of action and these drugs work against tumor cells. What we didn't know, and we will know conclusively at the end of this study, is do they function that same way once you can actually get them inside the brain? And we believe the answer will be a definitive yes. Great. Okay, can you explain the rationale for in-licensing TPI 287, and why now? Oh, yeah. So the rationale is simple. You know, the mission of the company has always been the same. We want to develop drugs that help patients with primary and metastatic brain cancer. These patients have almost no options today. It's just a disaster for them clinically, and, and every neuro-oncologist in the world will tell you the same thing. So that's the clinical need. Now, we have also always said that as excited as we are about berubicin, and believe me, we are excited, this is the best-looking drug that any of our investigators have seen coming through, the drug development pipeline globally in many, many years. It's why we have as many patients as we do. It's why we have as many leading, neuro-oncology centers collaborating with us. However, we have said there is no silver bullet for this cancer. This is a very difficult-to-treat cancer. It's very aggressive. It's very adaptable. You know, sadly, these tumors often respond to the insult of treatment by becoming even more aggressive, and so we have always known that we were going to need additional drugs in the pharmacopoeia to treat this cancer, and it's very hard to find a drug that fits our high standards. Again, looking for something that we had confidence would work based on clinical outcomes in that class of drugs going back decades. We had that with berubicin. We now have that with TPI 287. We needed a drug that conclusively crossed the blood-brain barrier. We've seen that with berubicin. We've now seen that with TPI 287. We looked for four years at over 250 other compounds that we potentially might have licensed in to start another clinical program. Eventually, we settled on TPI 287 as the one with the most promising clinical data in over 300 patients to date. It took some time, as these things do, to you know to put a transaction together with Cortice Biosciences, but we finally did, so what you're seeing today is not some sort of you know magical timing. It's really just the result of years of behind-the-scenes work, diligence, research, analysis, et cetera, finally coming to fruition in this transaction, so you know it's always really, I would say, been in our plan to do something like this. All the stars have finally lined up and we found the drug, and we're able to put a program and a transaction together. Great. And congratulations on the Cortice transaction, by the way. So I have one more question. You've had an action-packed several weeks on so many levels. Can you discuss where CNSP stands today related to your thoughts on the company's valuation and recent share price performance? Sure. I mean, look, you know, it's nothing new to hear me say that I think the company is deeply undervalued. You know, we're trading below cash. We have two incredible programs, one very late stage, that's going to read, you know, next year on top-line data for a trial that is powered, you know, not just designed to be pivotal, but powered to be pivotal. So we believe that there's a path to approval from this trial. You know, we'll find out, you know, of course, next year how FDA thinks about that. But to be trading where we are today and discounting all of this work to zero, really seems like a significant, you know, miscalculation on the part of the market. We think that the company is worth many times what it's worth today. But you know, the share price, I think, in recent weeks, is probably a response to, you know, a period of time that it looked like based on our, you know, earlier cash report, that we might run out of cash. That was never gonna be the case. This company was never gonna run out of cash, on my watch and on Chris's watch. We're nowhere near that. We're in a actually very strong cash position today. We feel like we're in a very strong position with having TPI in our portfolio. So we're feeling like, you know, the company is positioned as well as it's really ever been. It's unfortunate that, you know, once again, the market, you know, disagrees with that, but I think that, you know, as confidence in what we've done, filters through the market, we'll continue to see the share price recover, you know, is our hope and expectation. Excellent. Thank you. And John, I know you've been looking forward to this segment, so we are going to now get to the questions from investors and our audience. So the first one that was pre-submitted is: Can you provide an update on the current clinical trial in the pipeline and any significant progress recently made? ... Sure. So we're, you know, we're at the late stage of CNS-201. That's our designed to be pivotal study for berubicin. So really, at this stage, we are watching and waiting. You know, we have a number of patients, a lot of patients still on the study, and so we are following those patients, continuing to treat those patients, and, you know, collecting their information in our database on the trial. And as we do that, eventually we will reach the number of terminal events that we need to do our, you know, statistical analysis on the study and determine which arm of the study, berubicin or lomustine, performed better. But we are, you know, we are approaching that time, so we're still in the third quarter. We've guided that we will release results for that study in the first half of next year. And we're definitely, you know, on track to do that without question. So I would say that investors should, you know, feel comfortable with our guidance on the timing of the trial. In terms of what, you know, what we can see, nothing has changed. Everything is going along beautifully. You know, patients are being treated, data is being submitted and analyzed. And so, you know, that's basically where we are. Okay. Our next question: How is the feedback from trial participants being incorporated into the development of new treatments or products? Yeah, so you know, we have a whole host of secondary endpoints to this trial. Again, the primary endpoint is overall survival. Very simple. Who's living longer, those patients on berubicin or those patients on lomustine? There are many secondary endpoints, including a number of quality of life measurements and tolerability of this drug, as well as elements that go toward the design of the trial itself. So we have made modifications at times, you know, to the trial, to make it easier for patients, to make it easier for investigators. We've also, you know, done things to emphasize elements of the study to make sure that we're getting the absolute highest quality data. I think that, you know, one thing that may be lost on folks outside this business is that this is really a craft in a way. You know, we're not just collecting data from, you know, from silicon sources, right? These are human beings that are interacting with nurses and their oncologists, and their physicians' assistants, and their radiologists, and their pharmacists and all of that. We collect all of that information, and we look for places that we can do a better job by the patients and/or make sure that we are getting the highest quality data, the cleanest data, the most uniform data for our study. Because, you know, what we've said from the beginning is, when you say something is designed to be pivotal, as this study is, this is designed to be the pivotal and absolute definitive analysis of berubicin in this condition. So in order to do that, you wanna be looking at like versus like as much as possible. That always gets a little crafty when you're dealing with human beings because it's not just, you know, no one patient looks identical to the next one. But we have taken care to collect all of that data and make sure that it's as clean as possible, and that we get the best result at the end. Not just a positive result, but the most definitive result. Because the heartbreaker in clinical trials is, of course, when you have something that looks really good, but the data isn't clean, and so you can't give a definitive answer. We believe this trial will give a definitive answer on berubicin. Great, thank you for that. So I do see a lot... Several people have joined since the start of this segment. So for those of you that just joined, if you have a question for John, you can type in the Q&A button at the bottom of your screen, type in your question, and we'll get to as many as time allows. So our next question is: Can you provide insights on whether the recent dilutive measures will continue in the near future? Sure. So, you know, I understand, you know, the shareholders', feelings about some of this. I mean, of course, I'm a shareholder myself, one of the original shareholders, have put plenty of my own money into this project, so, it's painful for me as well. It's painful for everyone from the board to the management team, to all the shareholders and friends and family that have supported this project. So we are conscious of that, believe me, we understand it. You know, I can't really speak to our, you know, our future, financing efforts at this point, but what I can say is that, as always, we will be acting, in the best interest of the shareholders and all constituents to continue to finance the company, to protect our NASDAQ listing and to further the study. This means that from time to time, we do, of course, have to raise capital because, you know, we are not a revenue-generating company as of yet. Continuing this trial and delivering data from this trial, again, and keeping what I've been saying for years, is really the only way that we deliver, lasting and true shareholder value. You know, the stock may ride up and down, but at the end of the day, whether or not this project is worth, what we believe it is worth, will be a direct function of our success in continuing the trial to its completion, which of course, requires cash. We're basically, you know, in keeping with what we've guided for in terms of the overall cost of this trial. We're getting toward the end. Costs are beginning to come down as patients come off the study. And so, you know, we look to finance the company in the least dilutive manner possible. So it's been a very big challenge in the last few years. Investors have gotten very aggressive in this space in terms of adding, you know, warrant coverage onto deals and other, you know, anti-dilutive protective measures. You know, we've done deals that, you know, have included those features, of course, in the past when we've needed to raise capital. Now, recently, you know, we've been in, I think, a very strong position to do, you know, at-the-market transactions that are, you know, the least painful to shareholders, even when the share price is down. And that's really always what we're looking to do, is take advantage of the least painful, least dilutive, you know, capital measures that we can while securing a sufficient amount of cash to finish this trial, which is what we have on hand right now. So that's, you know... I know it's been painful. At the same time, we're very happy because on behalf of the shareholders, we have secured sufficient financing to complete this study, which again is the primary value driver that the company has been, you know, moving to complete for years. ... Excellent. So, you already answered part of this question in your response to the prior question, but, I thought it we would tie it in now. So do you personally invest your own money into the company's stock? And if so, what gives you confidence in its future performance? So I do. I do, and I have, and I will continue to do so. You know, of course, there's a lot of times that we can't, because we're in receipt of material, non-public information, so we can't trade. So, you know, shareholders shouldn't necessarily look at the timing, you know, of any insider investments as anything other than just being in response to those rules when we can and can't do things. But look, what gives me the confidence to do this is exactly the same information that the public knows. You know, we have talked ad nauseam about berubicin and why we're so excited about this drug. You know, again, it, to me, it just all comes down to how logical and how well this program holds together from inception to where we are today. The initial hypothesis was so simple that I think really anyone could understand, and that is to say, we have a very difficult tumor to treat. It's inside this very hard-to-penetrate barrier. We have a class of drugs that destroys the type of tumor cells in the test tube, but historically can't do it inside the blood-brain barrier. Well, well, what if we had a member of that class that could cross the blood-brain barrier? Well, now we have two. We have berubicin, an anthracycline that crosses the blood-brain barrier, and we have TPI 287, an abeotaxane that crosses the blood-brain barrier. Exact same philosophy, exact same idea. Start with something you know works definitively, get it across the blood-brain barrier, and then design a pivotal trial that will conclusively and definitively prove that that drug not only crossed the blood-brain barrier, but treated those tumor cells. I believe both compounds that we have can do that and do that very effectively. I think used together over time, they will absolutely materially change the way this cancer is treated. That's what gives me confidence. And probably, you know, more to the point, that's what, you know, gets me up every day and charging to do this work for the last seven years, because I think that we have an awesome opportunity that in many ways, I would say, remained hidden in plain sight. You know, these two classes of drugs had been somewhat dismissed for their opportunity to treat this cancer. And yet, when you could successfully modify each of them to be highly lipophilic and cross the blood-brain barrier, I think you open up a whole world of opportunities, but they're always based on the tried and true nature of these molecules. That's what does it for me. Great. Thanks, John. Our next question: Has full compliance with NASDAQ listing requirement been satisfied? And if not, could you elaborate on what is the issue? Yeah. So, we have satisfied the shareholder equity component quite comfortably through our financing transactions, which again, you know, was another piece to why we did what we did. You know, our listing is critical to us. We needed to preserve it, we needed to satisfy that, and really, the only way to do that was to raise capital in a short order. So, we have notified NASDAQ that we've satisfied that requirement. Of course, the bid price issue remains out there right now because we're below $1. Having said that, that particular deficiency has a fairly long runway for correction, so we feel like we've got, you know, plenty of time ahead of us, you know, to do that, and hopefully, you know, news coming, you know, later this year or, you know, early next year, will, you know, have a positive impact on the stock, from our trial. So, yeah. Great. Our next question: Has the NIH grant been awarded? No, it has not been awarded. It has not been awarded yet, so, you know, we don't have that grant right now. Okay. Our next question: John, thank you for being here. Is CNS the sole proprietor of TPI and berubicin? And to clarify, you're saying that so far, this drug, during its phase II trial, is so far performing successfully? Yeah, if I read the question correctly, yes, on both counts for these two drugs. You know, our TPI license, it's a territorial license, so there are some areas of the world that we don't have rights to, but we didn't feel they were, you know, as important as the areas that we do have rights to. And in terms of, you know, clarifying on the study, I should say, remind everyone, you know, we are blinded to the results of the study, so we do not have direct insight into the performance of berubicin at this time, and we won't until the end of the study. Having said that, I think we have two important indicators that we can look at for verification of how the drug is performing. The first is, of course, back in December, we announced that the Data Safety Monitoring Board, which is an independent group of physicians that reviewed both safety and efficacy data from the study at that point, recommended that the trial continue without modification. Our position on that is that had this drug been lacking on either front, that is to say that it appeared it was not well-tolerated or unsafe, or that it was lacking in any efficacy signal, they would have recommended that we stop the study for ethical reasons or potentially modify the study. What they said, instead, was continue the study, you know, as planned, which was an excellent indicator that the drug is safe, so far appears safe and must be generating some efficacy signal. On a sort of secondary basis, and again, you know, this is not primary data from the study. This is just us observing the number of patients that still remain on the study, you know, is very significant, and the length of time that they have been on the study is very significant. You know, this is a cancer that kills patients on average in four-to-six months when they relapse. Very, very short, very, very tragic, and all but unchangeable for these folks, frankly, absent some, you know, some new intervention. We're seeing patients remain on this study well in excess of those dates. All of that combined gives us, I think, a very positive feeling that things are going along well. Now, of course, you know, that's no substitute for final data and final statistical analysis, which will be coming at the end of the study. But as I said, you know, from the limited amount that we can glean at this point, being blinded to the study, we're very pleased with what we see. Great. Great. Lots of questions keep coming in, so we're going to keep going here. Okay. Okay, so our next question: Will you have to complete another reverse split if the stock price doesn't meet listing requirements prior to reporting berubicin top line data next year? Yep, sure. Good question. I guess I would say, I certainly hope not. I certainly hope that the market responds to the news and the efforts that we're putting out and realizes that, we are just trading at a ridiculous discount. I mean, let's put it this way, everything that we talk about today, substantively, in terms of berubicin and TPI 287 and the work that we've been doing for seven years, the market is discounted to zero, as if it doesn't exist. Now, that just doesn't make any sense to me. I think that the market has further discounted us at this point, even below the cash that we've indicated that we're holding, which also doesn't make sense. So it stands to reason that at some point we are gonna see, you know, we are gonna see the stock recover. Again, I can't comment as to our future financing activities. However, I can say that, you know, we think the NASDAQ listing is very important, and we will respond to protect it at the time, given the tools that we have at our disposal, if that's required. Certainly our hope is that, you know, well in advance of that, the market will recognize that this is a deeply undervalued stock. Great. Our next question: Is there any really good news for CNSP? Yeah! There's great news for CNSP. I mean, look, let me put it this way. I think we've got the only drug in a late stage trial that can really make a difference for these patients. I think that if we bring a blood-brain barrier penetrant anthracycline with good, solid results, an excellent safety profile, and total lack of cardiotoxicity to FDA, we will have a drug approval. I just can't imagine for these patients that if our data is strong. I know our trial is absolutely state-of-the-art and you know, top line, just beautifully conducted over all these years. If we bring that to FDA, I think we have a very good argument to get this drug registered. That's incredible. It's groundbreaking news. There hasn't been a drug approval in this space for decades. There's nothing like this. If you understand what it means to say you have an anthracycline that's non-cardiotoxic, you can forget about GBM, and you can say that you may have a drug that could globally supplant doxorubicin, which is one of the fundamental cornerstones of chemotherapy for a couple dozen different kinds of cancers, and we all accept its use, subject to a black box limitation on its cardiotoxicity. We just can't give more than a lifetime maximum of that drug because you create the, you know, the tragedy of, oh, we've cured the cancer, but now ten years later, we have patients dying of heart failure. We don't wanna see that ever. Berubicin may be the only non-cardiotoxic anthracycline out there. If it also crosses the blood-brain barrier and treats GBM, to me, this is a grand slam chemotherapy drug. You can look at exactly the same story in TPI 287. Abeotaxanes, taxanes do not cross the blood-brain barrier, so they're awesome for all kinds of other cancers. They don't cross the blood-brain barrier, so you can't use them in neuro-oncology problems. TPI 287 can. It was designed to cross the blood-brain barrier in the same way that berubicin was designed to cross the blood-brain barrier. We spent years looking for another program. We rejected over 250 other compounds, and I mean, we did more than just glance and kick the tires. We did deep dive diligence on hundreds of compounds. We rejected them all on the basis of, you know, safety, efficacy, clinical data or lack thereof, all of these things. TPI came to us having been tested in over 300 patients in mono and combination therapy, incredible safety profile, clear ability to cross the blood-brain barrier and knock out clinical results in GBM. So I am super excited about both of these things because they work together so beautifully, and they are exactly what we have been saying we wanna do with our expertise for years. You know, we didn't just pop out of nowhere. We didn't just suddenly appear on the scene with 45 leading clinical investigators and partnerships with institutions around the world to create a clinical network that enables us, in two and a half years, to enroll 252 patients to study berubicin, when other studies are struggling with GBM patients to recruit a dozen of them. We recruited them because we have these relationships. We've built this network, we've put this machine together, and now we wanna push more content through it to try to get as many helpful drugs approved via our efforts as possible. So I am, you know, incredibly excited about where we are and what we're doing. We're on the cusp of delivering results on berubicin, which we've been working on for more than half a decade, and we're ramping up and using everything that we've learned to study berubicin to start an entirely new program, but the one that fits just hand in glove with what we've done with berubicin. So to me, this is, you know, just about the most exciting time since we took the company public in 2019. Yeah, and John, I have to comment that you've been on our platform many times, and, you know, just thinking about the operational execution and that groundwork that you've laid is, you know, invaluable. You know, you think about what you're trying to accomplish with TPI 287, you know, on the heels of all of that ramp up and all of that work and all of that infrastructure for berubicin, you know, it-- I have to compliment you on, you and your team on all of your progress. Pretty incredible. Thank you. It's, you know, I mean, we didn't just build it as a one-off, you know? We built this. We made the investment of time and resources to build a machine that could get drugs approved. That takes, you know, years of collaboration and years of study and design and effort, and we've done all that now. So now we can run another program through it, hopefully much faster and even cheaper. You know, we have become incredibly efficient at doing this, and I think, you know, we've got a beautiful platform now staged for TPI 287. So it's, you know, it's what I've wanted for the company for a very long time. You know, and anybody that's, you know, that's tried to pull any sort of major partnership together knows, you know, they're multifactorial. There's layers upon layers of issues. You've got, you know, compatibility with the ideas. You want to take the project to the same place. You've got financing, you've got legal, you've got ownership issues, you've got all these things. Well, it takes time to solve those. We finally put all that together, and now we're really ready to, you know, to get to work. Yeah, and I just have to add on to one more thing. Just, you know, it wasn't that, you know, you put this team together, and all of a sudden, they happened, you know, to pull off, you know, this execution. I mean, you think about it. I encourage everyone to go to the company's website and look at the bios of the team. When you think about Dr. Silberman, who is responsible for Gleevec, you think about, like, your team and their background and their marquees of big pharma, you know, where they've had really strong experience, solid experience. So it's not their first rodeo. So I certainly am not doing a CNSP commercial by any means, but, you know, it is very impressive, and I do encourage those of you on the line, for sure to go check out the website, because I think it is about the team, right? I mean- It is. It's totally about the team. I mean, if you have the right cohesive team with the right skill sets and the right motivation, you know, I'm a big believer you can do, you can do anything. We have a very small team, but we are completely cohesive. We are all absolutely lined up on this mission. We have totally the right team, the skill sets, I would say, both at the team level and at the board level. You know. Yeah. As we go forward with berubicin, and we are approaching the end game, you know, in terms of having top-line data, hopefully moving to discussions with FDA and then commercializing, you know, it's one of the reasons why we brought Amy Mahery onto our board. Amy's the Chief Commercial Officer at Roivant. Now, Roivant is a $9 billion company, obviously considerably bigger than ours. Amy has, you know, miles of responsibility beyond what we have right now, but she's got world-class expertise in going to the next step. So we are planning for success on the team-building level. We're also planning for success on the future in terms of bringing in another drug. We said to ourselves, "Look, it's great that we have berubicin, and we wholeheartedly believe we are going to get this drug approved. But as it starts to move down that process, what do we do with this big engine that we already built? Well, we got to have something else to put through it because otherwise we're not extracting full value from our investment in what we've built. Now we have something, and we're going to be doing the same thing again. Now, with respect to that you raised a good point with respect to Amy. What is your commercialization strategy? Are you speaking with pharma? Are you having conversations, or are you going to do it alone? No, no, I... We are, we definitely are having conversations with big pharma. You know, you can imagine that at this point, really, what you're doing is a lot of get to know you work. You know, these transactions, partnership transactions of that nature, take time to build, and you want to get to know the people that you're working with and so on. And also, you know, they want to understand how we think about drug development and, you know, are we serious players, and have we built programs, I guess, that one might say are commensurate with the experience of our team? You mentioned Dr. Silberman and Gleevec, you know, Dr. Picker and carboplatin. These are world-class, blockbuster chemotherapy drugs. Our team knows how to do this. We know how to develop these programs and these clinical trials, so we're giving confidence in that, but really, the rubber meets the road for partnership discussions when you actually have definitive data, and we will have that, but you want to prime the pump, so to speak, in advance, so you know, we're doing a lot of that type of work as we go, and you know, I have no doubt that given the potential, you know, groundbreaking nature of what we're building here, I have no doubt that we will have our pick of commercialization partners going forward, and you know, Amy has certainly been instrumental in helping us understand how those things work, and she'll, you know, continue to guide us as we go forward. Wonderful. All right, our next question that's come in: If the drug was not performing, and I'm assuming it's berubicin, is it accurate to say that the trial could or would be suspended? ...You know, it really, the best, most accurate answer is, it depends. It depends, you know, on what the lack of performance is. Can it be corrected with additional data? You know, is it a fundamental flaw, et cetera? I would say that, again, pointing to the DSMB, the back in December, the best indicator that we have that the drug is both performing in a safe and efficacious way, is the fact that they recommended that the study continue without modification. You know, if it didn't look like it was doing anything, in other words, it was wasting some very sick people's time, they probably would've recommended that we study, that we terminate the study or we suspend the study. If patients were just having an awful time tolerating the drug, or its side effect profile was so terrible that it made, you know, any benefit, you know, pale, they probably would've recommended that we suspend the trial, but they didn't, and so we are proceeding according to plan, because every indicator that we have is that the drug is doing what we want it to do. Okay. Our next question: Will we have a preliminary efficacy readout sooner than the first half of next year? We will not. We are blinded to the study, you know, to maintain the study's integrity. It is absolutely critical that we remain blinded until we turn over the final card and lock the database. So we will not have any preliminary look at that because, you know, we would, you know, at best spend alpha, as they say, meaning we would take away from the top number, top line number of patients that we have, and we would have to add in more patients or events, which would add to cost and add significant delays. So we certainly don't wanna do that. And so we are waiting right along with everyone else to see, you know, how it does when we decide that we have a sufficient number of events to power the study for its primary endpoint, overall survival. Okay. The next question: Will berubicin be used to treat breast cancer metastasized to the brain off label prior to a new clinical trial? Yeah, that's a good question. I mean, I guess I can say, you know, we can't really comment, you know, on that, but what I... Because, you know, we have an indication that we're looking for. We have a primary objective in this study, that's what we're focused on. You know, anything else, were this drug to be approved, would be, you know, at the skilled intermediaries, discretion. So we really can't, you know, speculate on what it could be used for. Having said that, I would say this, you know, many types of breast cancer are anthracycline sensitive. Many types of breast cancer have a well-known, metastatic pathway to the brain, and, brain metastases are just as difficult to treat as primary cancers because they exist behind the blood-brain barrier. There aren't any other anthracyclines that we're aware of that penetrate the blood-brain barrier other than berubicin. So there's a certain logic to think that this is a drug that should be studied and investigated for those type of cases because of its unique properties. It'll be another step down the road, but you know, in addition to TPI 287, we have often said that we believe berubicin represents the possibility of a pipeline in a drug, whether it's metastatic breast cancer or other metastases, or other primary indications, or other cancers that have nothing to do with the brain, but that are anthracycline sensitive, and there might be an opportunity to replace a cardiotoxic anthracycline with a non-cardiotoxic anthracycline. I think you know, four or five things I just mentioned would probably keep us busy for the rest of my career. Great. Okay, our next question: With the stock price now back below $0.20, just three months after the split, how do you plan to create and sustain shareholder value? Well, you know, again, the way we create shareholder value is getting drugs approved. End of story. There's really nothing else. It is that simple. Now, what we can do in the interim to having a drug approved or having top-line data, is to get out and do what we're doing right now, just talk about the fact that, you know, don't just take my word for it, that the company is undervalued. You know, take a look at what I've said. We're trading below what we talked about in our recent filings in terms of our cash position. We're trading, as if all of the work that I've discussed here today and have been discussing for the past, you know, five years, never existed. It's literally been discounted to zero. If any of you think that makes sense, then maybe you're not CNSP shareholders. That doesn't make any sense to me either. The company is tremendously undervalued on an objective basis. I can't. You don't really need to evaluate a lot to say, yeah, if all the work that the company does has been discounted to zero because they're trading even below the cash that they have. Well, that. You know, you either believe in what we're doing, and you believe in the data behind berubicin, or you believe in our ability to execute, and you believe the things that we've said about the trial and what we've seen and so on, or you don't. And now we've added a whole another compound into our pipeline, which we think could be just as big as berubicin down the road. I think there's a huge amount of value there that remains to be unlocked if the market, you know, pays attention and understands, in particular, that the financing overhang that has, you know, shadowed our work for years in terms of our ability to have enough cash to finish the berubicin study. We've eliminated that. We have enough cash to finish the berubicin study. So, I think that this is a stock that has, maybe let's hope, the tail of a long shadow sitting on it, and we can hope that some of that starts to come off as people realize, "Wow, this is, this company has a lot going on." The market is not treating it rationally by two very objective measures. That sounds like, you know, an undervaluation to me. ... Great. We have a comment that's come in, and I want to read it. So, "I somewhat blindly invested last week based on steady climb across five days, and I just wanted to say that it is very refreshing to jump on this call and see and hear a competent CEO answering questions with no hesitation. Keep up the good work. Looking forward to the results on this study next year. Thank you. That's nice to hear. I mean, I know I haven't won any popularity contests recently, but, you know, we really are, we're working very hard on the same mission that we've always had, and sometimes it's tough. You know, you've got tools at your disposal to fix things in terms of the stock or what have you, with NASDAQ. You don't want to use them, sometimes you have to. You know, that's what we're here to do, is make those decisions even when they're tough and even when they inflict pain on ourselves as shareholders. You know, we have a very clear mission at this company. It's very clear. It's, you know, non-dilute. We do one thing, and that is try to get drugs approved. I believe, you know, as I've said many times before, this is a multi-billion-dollar opportunity globally for drugs for this disease and other neuro-oncology diseases. These diseases are incredibly difficult to treat, and they are difficult to treat because of the very thing that separates the two molecules that we have from every other molecule out there, and that is, these are well-known drugs that cross the blood-brain barrier. That is as logical approach, as logical an approach to solving the GBM problem as I can think of, which is why I've given this project seven years of my life, why I've invested my own money in it, why I continue to do it day after day, and why I'm more bullish today than I ever have been about it, because I feel like we are finally closing in on an answer on berubicin. We have another compound that I'm just as excited about, that we think will go even faster and cheaper than berubicin did, because we're just using the same, you know, machine, so to speak, that we've built before. This is like the fruit, the realization of a dream that I had, and that, you know, the rest of us at the team had, in terms of how we could build a really lean and mean, super focused drug development company to help these patients. I would say kind of in conclusion to that, you know, it's easy to answer questions directly because we really believe in what we're doing, and what we're doing is ultimately trying to help patients. You know, I had a long talk, you know, the other day with a, you know, very successful, biotech, investor and, you know, it was refreshing and nice to see that we both understood that in this game, you know, if you focus on the patients, everything else will follow. And we really are focused on these patients. We believe that these drugs could be game changers for folks. Very close friend of mine just lost his mother-in-law last week to GBM. You know, sadly, there was really nothing that we could do. It was caught so incredibly late, but it was another, you know, just crushing, story close to me of somebody who, you know, everything was fine, until it wasn't. Then she was in the hospital, and then she was having neurosurgery, and then, about eight weeks later, she passed. Now, that's just a tragedy, and it's just a tragedy, and I think that we can do something. What we've seen so far in berubicin tells us we can do something, and what we've seen demonstrated in published data on TPI 287 tells us we can do something. If we do something here, shareholder value will follow, share price will follow, cash will follow, a partnership will follow. We just have to focus on our job right now, which is producing the best, cleanest, most definitive data we can on these drugs. Excellent, John. All right, our next question is: When you mention the trials are international and domestic with hundreds of patients, is it safe to say that this is a robust and competitive trial? Absolutely, it is. It is a very robust trial. You know, this was a conscious decision that we made at the beginning. We could have taken a more cautious, tiptoe approach. A traditional development approach would've been to say, "Okay, we had 27 patients available for evaluation for the phase I. It was very exciting. It clearly showed efficacy, but let's prove the efficacy component first. So let's do a 60-patient study, blah, blah, blah, then we'll move on to a big phase III." We would still be in the little study somewhere. Maybe we might, you know, have done something with it that way. But I said, "You know, I think that's going to take years longer than necessary." This is a disease, very sad for the patients, never spontaneously resolves. But for investigators, a very interesting feature to the disease because you're not, you know, potentially looking at some sort of, you know, a self-resolving cancer or a cancer that's, you know, that's going to be benign in some people. This disease kills basically everyone, and it kills them very rapidly. If you see patients that are not dying quickly, if you see patients whose tumor is stabilizing, if you see patients whose tumor shrinks or disappears, you know it's because your intervention is working, colloquially speaking. So I said, "I have enough rationale, I have enough justification in my mind to go for the whole thing," to say, "Let's design a pivotal study. Let's design a study with enough patients to power an answer on overall survival, because if that's what FDA wants, then that's what we give them." And, you know, there's a great, you know, adage in this game, you know. There's only two rules in drug development. Figure out what FDA wants, and then, you know, for God's sakes, just give it to them. Well, that's what we're doing here. We're not tiptoeing toward it. We're charging forward to give them exactly what they want. Definitive, robust, clean, top-line data on overall survival, going head-to-head against the current unapproved standard of care in GBM, and the best drug will win, and we think that's gonna be berubicin. Great. Next question: Was the new drug in-licensed due to Dr. Silberman's experience with the compound? ... Yeah, excellent question. Good, digging and diligence. I would say the answer is, in part, yes, of course, we felt familiar, with the drug because of Dr. Silberman's involvement, with its earlier development. We felt that we had a leg up in, diligence because of Dr. Silberman's involvement, and we could, you know, really understand some of that data, very deeply because she helped to create it. Having said that, we hired a number of outside consultants to review the data on a completely independent basis to make sure that there was no confirmational bias creeping into our diligence process. You know, you don't wanna, you don't wanna say, "Oh, well, you know, my friend did this, and therefore, it must be great." You know, I believe that because I think Sandra is one of the best in the world at what she does. That said, you know, I have a duty to the company and to the shareholders to make sure that we're making objectively the best decision possible. So, we didn't just kick the tires with Sandra, although she was incredibly helpful. You know, we went top to bottom with outside experts, looking at all aspects of the program, from clinical to statistics to CMC, you name it, to patents, and we felt comfortable at the end of all that, that we really had something that was worth our time. Great. And you looked at other assets as well, or? Over two hundred and fifty other assets we reviewed. Great. Okay, so our last question that has come in, before I send it back to you for some closing remarks. So, do we have any newsworthy of a press release that you mentioned these details today about our pipeline? Can these be reiterated along with the cash value statement you made, and perhaps stock buyback something moderate, $50,000, perhaps into the press release? Hmm, I'm not sure about the last piece. I know. But I'll try to answer the rest of it. Yeah, I mean, you know, we put out news when we have news that's newsworthy, and it's a little circular, but I think you know what I'm saying. We try to get these, you know, we try to get this information out there. That's why, you know, I like doing things like this, because we can just talk freely about it. We try to get it out in press releases as much as we can. And we'll continue to do that. You know, we have a pretty robust conference schedule in both, you know, in the United States and in Europe this fall. So we'll be out on the road talking to institutional investors, talking to family offices, talking to high net worth individuals, the folks that can help really move the stock. We try to get, as I said, as many, you know, news releases out when we have something to say, as we can, and hit on some of these things. I think our last, you know, big one that went with our Q, I think was really good, and the K around Cortice and the TPI in-licensing, I think helped to really explain some of these things. But, you know, look, we wouldn't be the first company that just kind of got lost in the market shuffle, especially, you know, in biotech. I mean, there's a lot of companies that look, you know, on paper like ours. I think what distinguishes our company when you get below the surface, is some of the things that we've talked about here, how focused we are, how dedicated we are to this very particular mission, how very, very real and in biotech, very near term, our opportunity is on berubicin. You know, I almost can't believe, frankly, that I'm saying, you know, in, you know, sometime in the next three quarters, we're gonna have definitive data on berubicin. This has been a seven-year project in my life, so I'm really excited and totally confident that we're on the right track, but we're gonna have a definitive answer in the near term there. Similarly, you know, I have been hoping, and people have been asking for many years, you know, "Is there anything else coming in the pipeline?" Et cetera, et cetera. We really couldn't say anything because we were doing diligence, we were looking at other things, et cetera. Well, now we found something that we can be just as fired up about, for you know, for patients and for our shareholders as we can be on berubicin. So you will hear more about those things as we get the development program moving on TPI. You'll start to see press releases on definitive steps we are taking to move that drug to the clinic because it's a, you know, an enormous amount of work before you actually get to the point where you're, you know, introducing a drug into a human being. So, you know, the beginning, that work has already begun, and as we have, you know, elements of that work that we feel are newsworthy, we'll, you know, present them, but know that this is what we're working on. This is the story. We firmly, you know, stand behind these notions that, you know, the company is undervalued. Just on an objective basis, it seems like I don't know what other conclusion you could have. And know that there is an enormous amount of value that we think can be created and unlocked, you know, beginning with our berubicin program, when we announce, you know, results from our study. Excellent. Well, John, that was our last question. I feel like you gave a summary in that response. Okay. But I do wanna give you one more opportunity, before we close, if there's anything you'd like to say, to our great audience. What a wonderful group of questions we've had, a lot of back and forth, so really appreciate their time and attention. But any closing remarks on your end? Yeah, I mean, I'm, you know, thanks for all the questions, and thanks for the attention to the company and the story and what we're doing. Certainly appreciate all that. Always happy to answer shareholder questions directly. In conclusion, I would just say if it's not clear yet, we are on a mission, and the mission is to help these patients that don't have any options today. I think we have taken the most logical path that you can take. Start with something you know works, get it to the place where it needs to go, and then test it definitively in that place and deliver the cleanest, most meaningful top-line data on the endpoints that matter to regulators. If you do that, the rest of it is chemistry and biology. We can't control how berubicin interacts with these tumors. What we can control is how we analyze and capture the data of those interactions, how we analyze all of those interactions among all of these patients, how we synthesize all of that data and deliver it to FDA. I believe we're as good as anybody in the world at doing that, and for these drugs, I think we're the best in the world at doing it, and we are going to get this drug approved. There will be an incredible, you know, unleashing, I think, of value at that point because the clinical need is enormous, and you know, the rest of the world may not understand this, but you all, certainly as our shareholders, I believe, understand the fact that this drug has legs for decades going forward. As a non-cardiotoxic, brain penetrant anthracycline, the sky is the limit for what you can do with this drug in oncology, and we will see it do those things going forward. Similarly, we now have a second compound that I think the same things can be said about, and we're just getting going in that. So I am, you know, both incredibly energized about what we're doing with berubicin and also renewed energy in terms of starting a new program because of how exciting, TPI 287 is as a compound. So, you know, I think it's a great time to be a CNSP shareholder. I, you know, I know that there's been pain and there's been, frustration, and shareholders have had to have a lot of patience, to get here. But I think, as I said, we're in as strong a position, if not the strongest position that we've been in, in many years. And and that's where I wanted us to be, you know, going into a period next year when we know we will have a definitive answer on our first program. Great. I think we'll end with that, John. And with that, this concludes our Virtual Investor CEO Connect segment, featuring CNS Pharma. I'd like to extend a huge thank you to John Climaco for joining us today. And wow, I'd like to give a huge thank you also to our audience. Great, great questions. So glad you kept them coming in. So as a reminder, CNS Pharma trades on NASDAQ under the ticker CNSP. And if you like what you saw today, I encourage you to visit cnspharma.com for more information on the company, to sign up to follow the company, to receive their alerts, as well as to follow their social channels to stay current on the latest information. And you can also visit virtualinvestorco.com for a replay of today's segment, as well as our latest segments and event calendar. John, thanks again, and I wish everyone a great rest of your day. Thank you.