Global Investment Conference 2024. My name is Daniel Smith, and I'm an H.C. Wainwright Equity Research Associate in Biotechnology. With that said, let me introduce our presenter for the session. I'd like to welcome Mr. Leonard Mazur, Co-Founder and CEO of Citius Pharmaceuticals. We're developing a variety of treatments for oncology and infection prevention. Citius is traded on the Nasdaq under the ticker CTXR. The floor is yours. Thank you. First of all, I wanna thank everybody for participating and listening in on our conference and my presentation. It's a pleasure to be here at the invitation of H.C. Wainwright. As most of you know, H.C. Wainwright is our primary banker. That over the years, we've probably raised over $200 million with them. Before I get started, since I'm gonna be making forward-looking statements, I think it's very important that all of you consult either sec.gov or citiuspharma.com, our website, because an informed investor is the best type of investor. On those two websites, you'll find everything and anything related to the company and its filings. With that, let me get started here. In terms of the highlights of the company, just probably one of the most important facts that we have as far as the company is concerned is this, and you're not gonna hear this anywhere else except here, and that is that we have our own money in the company. We've invested our own funds. So I have invested directly $22.5 million into the company. Myron Holubiak, also the co-founder of the company, has invested $4 million of his own funds into the company. That's not in stock options, that's in direct investment. We went side by side on a number of the raises. So we do have a very late-stage portfolio, and I should highlight for this for you. We do have one drug that's approved. LYMPHIR was approved about a month ago, a drug for denileukin diftitox. It's approved for the treatment of cutaneous T-cell lymphoma, a very rare cancer, afflicting about 3,000, roughly 3,000 people in the United States annually. We also have Mino-Lok, which is in phase III, which concluded a phase III trial, a unique drug in that, once it's approved, it'll be the only one of its kind in the marketplace. It contains an antibiotic along with sodium EDTA and alcohol. It's designed to sterilize infected catheters, central venous catheters that are long-term, mostly in cancer patients, that cause infections known as central line-associated bloodstream infections. This is the only standard of care today is to remove those catheters surgically and replace them in a different part of the body. Our top-line data that we had, that we released several months ago, we had outstanding statistics associated with it that I'll cover shortly. We also have a hemorrhoid drug that is also in phase II right now, presently. The reason we have it is we actually picked this drug up when we merged in with Citius. We started out as a private company back in 2014, merged in with Citius, and then went uplisting. Inside of Citius at the time was this drug. We took a good look at it. It's not necessarily a fit with what we have, 'cause we like very highly specialized situations where it's a small number of doctors, small patient populations. But, believe it or not, in the 21st century, there isn't a single FDA-approved prescription drug for the treatment of hemorrhoids. Nothing. What you do have is, you have the over-the-counter market, which, Preparation H and products like that, but those are for phase I category or category one hemorrhoids. They're not for category two, three, or four. So as a result, we're gonna we're doing some trials, and if we can show that we have efficacy and it works, we'll monetize this asset for the shareholders. 2024 has been an unbelievably productive year for us in that one. LYMPHIR was approved in August 2024. We're gonna have commercialization of this drug starting in January 2025. We spun off, and we put LYMPHIR into an entity called Citius Oncology, Inc. We spun that entity off and had it acquired by a SPAC. The SPAC and the entity now is trading as Citius Oncology, Inc., as CTOR, and we hit all our primary and secondary endpoints in the Mino-Lok trial. So, basically, we're, as far as Citius Oncology is concerned, it's we own 92% of the shares in that entity. What does that mean? That means all the shareholders own 92% of it as well, because it's owned by Citius Pharmaceuticals Inc. It's been Nasdaq listed. It's got a ticker symbol, CTOR. We have, I think, a good opportunity here. The plan is, or the goal for us, is to ultimately distribute the shares in Citius Oncology, Inc. To the Citius Pharmaceuticals shareholders. That will take place under the appropriate market conditions. So, with that, also, as you can see here, in terms of, the future for the drug, we have two Investigator INDs, that I'll cover a little bit later as well. And where it's being combined in the case of University of Pittsburgh, it, LYMPHIR is being combined with KEYTRUDA. The reason it's being combined that way is because, we have a very unique mechanism of action with LYMPHIR in that, it lowers the Tregs in the microenvironment of a cancer cell. That has, important implications when it comes to KEYTRUDA, because KEYTRUDA actually, and other PD-1 inhibitors like it, will tend to increase the number of Tregs. With an increase, the overall efficacy of those at those entries can get lowered. By combining these, it'll optimize and improve the overall performance, at least that's the scientific theory behind it. It was proven out in an animal trial that was done, that we'll cover in a bit. Basically, we're now FDA approved. We've just announced several days ago, LYMPHIR has been added to the National Comprehensive Cancer Network, NCCN, for [inaudible] with Clinical Practice Guidelines in Oncology, supporting adoption and reimbursement. One of the good news about this drug is this, that there's competition in the market. There are two other products there, and because the competition exists, pricing has already been established, reimbursement has been established, so we can piggyback into those areas very quickly. So, as I said, commercialization is anticipated to begin in the beginning of 2025. We've already started, we've staffed up at the, more or less, at the headquarters level. We have a vice president of marketing that we brought in from Hoffmann-La Roche, who launched all their hospital antibiotics. We also have a director of marketing from Regeneron. The national sales manager came in from Kyowa Kirin, which is one of the competing drugs in here. He launched those, that drug into the marketplace and had an outstanding launch. We've been studying this market for two years now. We have a real good idea, not better than an idea. We know where every treater is. We know where all the patients are. We've already set up all the sales territories. We're working with a company called EVERSANA to work with us on executing our marketing and sales plan. So, this is just a quick look at cutaneous T-cell lymphoma. It is an awful disease. It's one that it first starts out, it looks like a rash almost, and it's treated by the dermatologist. When it enters into the tumor phase, it then moves to the oncologist. What characterizes this disease, which makes it really awful, is severe itching, and that's one of the areas that we do provide relief for that patient. So, this is just a quick overview in terms of the MOA, as I, the mechanisms of action that I described before. As you can see, it's an interleukin-2 receptor that offers a unique treatment opportunity in CTCL. We target malignant cells, and we eliminate the immunosuppressive Tregs. In terms of the competition, so ADCETRIS, which is formerly a Seagen drug, now Pfizer, Seagen was acquired by by Pfizer recently, is in the marketplace. POMALYST, which is Kyowa Kirin, which I've addressed before, is there. ISTODAX, which BMS has, they've de-emphasized this drug. They're no longer promoting it, so the two primary competitors are those, are those two drugs. Here's what makes this market interesting for us. Most of the time, it's been my experience and any other marketer's experience, when you come into the marketplace, you're expecting to take market share away from your competitors. That's not true in this case. What it is, is we're actually additive to the market. The reason being is because of the way the oncologist practices. None of these drugs are curative, and what that oncologist is trying to do is extend the patient's life and make the patient more as comfortable as possible. As a result, they'll go from one drug to another. There's no one, two, or three paradigm here or anything like that. There's no sequence, no order. He can go from one. It just depends on the side effects, and it depends upon the efficacy that they see overall and what they're getting with results. They're likely to switch very quickly. One of the factors here that's important also is that the patients in this segment are very active. They have their own websites. They're looking at all anything new, anything being studied, like all patient groups of this type, because this is potentially life-saving for them. So in terms of the clinical trial that was done, as you can see, it was. There were two studies actually. One was a lead-in, and the other one was a main study. The lead-in had 21 patients, and the main study had 71 patients. So basically, in terms of overall results, 36.2% objective response rate. Nearly half the patients or 49% experienced either a complete response, partial response, or durable, stable disease, which is one of the characteristics of measuring the effect, overall effectiveness of a cancer drug. So in terms of the meaningful response, the skin burden was reduced by 84.4%. This drug tends to work quickly, meaning 1.4 months on average, and we have a durable response of about six and a half months. So overall, it was well-tolerated. The overall side effect profile was not that much different. I should highlight for you very quickly, this drug was on the market before. All right? So Eisai was the company that acquired this drug from Ligand, the original developer. What happened was, it was approved. It was on, it was selling for three years on the market. As a condition of the approval at the time. Eisai agreed, the FDA had stipulated that they had to remove unfolded proteins from the formulation, not for safety reasons. This drug is very hard to make, has long lead times, and Eisai was in the process of changing manufacturing locations, and I guess the FDA must have leaned on them. So they decided that they had an inventory problem, and an availability problem. They took the drug off the market while they did the reformulation work. They complete the reformulation work, they go back to the agency, submit all the data, and the agency says, "Sorry, you have a new drug, and you have to redo phase three again with that lead-in," and the results that we had here were pretty comparable to what was shown before in the original clinical trials, so as I highlighted for you, we do have some opportunities for growth here. Peripheral T-cell lymphoma is one of them. It's approved in Japan for that, like, Eisai got it approved there, and it's something that we'll be looking at as we roll out, but our first priority is establishing this in CTCL. We have these two potential immuno-oncology upsides at University of Pittsburgh. I should highlight for you the University of Pittsburgh data on this. It will be presented at a conference. It's been accepted for a poster presentation in October. The other one is at the University of Minnesota. It's also an Investigator IND, where LYMPHIR is being combined with CAR- T. What I like about this for us is, it puts our drug and us at the forefront on breakthroughs that are occurring in the cancer treatment market. So this was a study that I referred to, the animal trial that was done, where it combined LYMPHIR with a PD-1 inhibitor. This study clearly demonstrated that the combination worked better than monotherapy. So with that, let me move into Mino-Lok, because we've got about five minutes to go. I'll cover this quickly. So basically, as you know, Mino-Lok is indicated potentially for sterilizing central venous catheters, long-term central venous catheter, meaning longer than 30 days. All right? These are the types of catheters that are out there. Most people don't know this, but the catheters get inserted surgically by the subclavian by the collarbone, threaded right to the heart, to the superior vena cava, and they're a lifeline for everything, meds, everything. So the inventor of this drug is Dr. Issam Raad, Chairman of the Department of Infectious Diseases at MD Anderson. He decided that what he had to do is, he had to come up with something that you could administer in the shortest amount of time possible, so as not to compromise the integrity of IV flow. That meant doing this in a shorter period of time, because they're the hospitals themselves sometimes will create their own sterilizing solutions, but they can take either days or hours, or long, long, long hours in terms of trying to sterilize it. So basically, what happens when a catheter gets infected, something known as biofilm forms on the inner walls of the catheter and a line, and that biofilm is basically, the best way to describe it, it's bacterial slime. And the reason what happens here is the bacteria have an affinity for the plastic. Once it gets in there, they propagate very, very quickly. It's very hard to get rid of the biofilm, but we do get rid of it. The catheter, as I said, is a lifeline, and the current standard of care is to surgically remove the catheter, replace it somewhere else. Usually, the replacement takes place in a groin area. It gets threaded up. When it gets threaded up, there's about a 20% adverse event profile associated with it. It's extremely painful. The patients hate this procedure. Basically, the market size for this is 500,000 catheters are infected annually in the United States. It tends to be underreported, because if it gets reported as a hospital-acquired infection, the hospital will not be reimbursed. It gets somehow they report it differently. What happens here, the way Mino-Lok works is the patient's just sitting there. The nurse will come in, inject the solution into the catheter. The catheter itself gets locked, so the solution does not go into the body. It gets locked using hemodynamic principles. The nurses are very familiar with doing this. They do this multiple times a day, and the solution will sit there for two hours. At the end of two hours, the nurse comes back in, aspirates out all the contents, and flushes the line, and the patient has 22 hours of uninterrupted IV flow, which is really important. So you do this five to seven days in a row, and at the end of that time period, that catheter and that line is completely sterilized. So we had a phase III trial, where we compared the Mino-Lok. The FDA wanted a comparator, so it was compared to the home brew solutions that the hospitals mix up. Usually, that happens when there are patients that no longer have access points, and they can't give them another catheter or replace it with another catheter. They have to try and salvage the catheter if they can, so we had, as compared to this, the endpoint was a comparison of time to catheter failure, and in that time frame, what happened was we had our p- value was p, it was 0.0006, which is outstanding. So with that, we're in a process right now of assembling all the data. We'll be going to the FDA. We'll have a meeting with them to discuss these results. We'll see where we are at the end of that meeting. So, one thing I should highlight for you, the FDA, at their advice that we file for something known as QIDP, a special status, Qualified Infectious Disease Product. We get a review in six months instead of 12 months. We also get an additional five years of market exclusivity on top of the almost four years that you get with Hatch-Waxman. It's better than patent protection because a generic can't jump you. So, we also have fast track and supplementary protection in the European market. I'm coming down to the end here, so very quickly, Halo-Lido is potentially first FDA-approved prescription drug. It contains halobetasol plus lidocaine, and we've got some data that we're going to the FDA with, and we'll keep everybody informed as to how this works out. We're not gonna spend a lot of money. We don't wanna do a big, major trial. If we can't get as much data as we can for the least amount of cost, and then see if we can't sell it off or license it out. So, with that, I think I'm down to 14 seconds, so you have time for one question, if you'd like, from the moderator. Okay. Go ahead. Hi. Do you effectively monetize the LYMPHIR asset by spinning it out into a public entity? Two-part question.