All right. Well, thank you, everyone that is in here right now. Our next presenter is Leonard Mazur with Citius Pharmaceuticals. Take it away.
Thank you for the introduction, and I appreciate all of you taking the time to be here with us today. I especially appreciate those that are online joining us as well. With that, let me go through this. This is an important statement here that I want everybody to read because, especially if you are having difficulty falling asleep in the evening, read this from the beginning to end.
By the time you get to the end, you will be sound asleep. Nevertheless, what is important here is that all of you do everything you can to find out as much about the company that you are investing in. That includes going to sec.gov, type in our symbol, and everything will pop up, all the information on the company. Also, our website has all our filings and all the relevant information on the company.
Historically, before I get into this, there are two companies here. One is Citius Pharmaceuticals, the other one is Citius Oncology. The reason for that is because when we started the company back in 2014, myself and Myron Holubiak, who was former president of Roche Laboratories, we started as a private company. We funded all the work ourselves.
What we did is we in-licensed the drug from MD Anderson in Houston, which is the leading cancer hospital probably in the world at this point. It was an antibiotic lock solution that you will hear more about that will eradicate infections inside of infected central venous catheters. We went along privately for a while, funding everything, and as you can see there, basically we have put in a substantial sum of money into the company.
I have $22.5 million invested directly, and Myron Holubiak has $4 million of his own money invested directly, something you will not hear from anybody else in this conference. For the most part, unless Phil Frost is presenting here. At this point, in terms of, we went along as Citius Pharmaceuticals and then, subsequent to some raises that we did back in 2021 when the markets were really great, we raised close to $120 million at that time in one month.
An opportunity came our way for a drug that was for a rare cancer, cutaneous T-cell lymphoma called LYMPHIR, that was being divested by Dr. Reddy's of India. We decided then to put it into a subsidiary company. We basically paid $40 million up front for that asset at that time. It was an auction. We went along.
The drug did get approved very quickly. We made a decision at that point that what we wanted to do was to see if we couldn't get that sub to trade on the market under Nasdaq so that we could raise the capital that way for the launch of the drug so that we wouldn't dilute the Citius Pharma shareholders with the funding that was going to require for launching LYMPHIR.
We did that, and what happened was Maxim actually came to us and had a SPAC. SPAC basically acquired the sub. We became the 90% owners of that sub in that process. As a result, we were traded on Nasdaq immediately because of the SPAC acquiring, became CTOR, so we have CTOR, which is Citius Oncology, and CTXR. You'll hear about what we have inside these two companies.
LYMPHIR is the principal asset inside of Citius Pharmaceuticals, Citius Oncology. It basically has been launched. We actually did a launch in December of this past year, where we shipped a product to the wholesalers. We wanted to set everything up for the launch of the drug so that when the sales force was fully out there, which they weren't at that time, we had everything covered for them. As a result, what we have at this point is everything is in place, reimbursement, coverage, insurance, shipping, billing, invoicing, all the functions that you need are in place. We'll cover later in terms of that. We did a recent financing where did a warrant exercise for 11 point-
Is the J-code in place?
The what?
The reimbursement code with CMS?
The reimbursements are 100%, including Medicare. We have 100% coverage. We basically did a recent financing as well, with a $11.5 million warrant exercise plus $10 million of debt that was the first tranche of a $25 million facility. We did a previous raise, that was for CTOR, CTXR, we did a $5 million raise in April. Let me get into LYMPHIR and Citius Oncology. CTXR owns 71% of Citius Pharmaceuticals. It's a standalone public company. We have a shared services management agreement between the two companies.
The same management team that is in place for Citius Pharmaceuticals is also the same identical management team for Citius Oncology. It makes it this way, it's much more economical for both companies. The market size for LYMPHIR is about $400 million. It's growing now to about $500 million at this point.
We acquired all the rights to the drug except for India, Japan, and certain parts of Asia. There are some investigator INDs that I'll describe shortly underway with LYMPHIR. LYMPHIR is actually the very first new treatment in cutaneous T-cell lymphoma. It's a rare cancer. It's an awful cancer, and I'll show you shortly in terms of that. It's an IL-2 receptor-directed cytotoxin indicated in the treatment of adult patients with relapsed or refractory stages one through three CTCL or cutaneous T-cell lymphoma after one prior systemic therapy.
These patients suffer greatly with this cancer, and you'll see it in a second. We've got commercial supply now across the board in all the wholesalers. We've got early adoption taking place without a major sales force present already in certain institutions, and basically broad payer acceptance right across the board.
We started limited international distribution as well. Just some quick numbers in here. Basically, we've got $7.1 million worth of revenue for the first three quarters. We're on a September fiscal, I should explain that. Both companies are on a September 30th fiscal. Basically, we're now into our last quarter coming up. With that, 44 institutions have already pulled the drug out of the wholesaler.
This again took place with a very limited number of people. We didn't have the full sales force on board until actually two to three weeks ago, when finally we got all 29 people in place. We're going to do real well here once all those feet on the street really start synchronizing and working well together. We've got 135 health plans secured in here, and 100% of the lives are being covered.
So, basically, this is just to show you some of the growth that's taken place as far as from the institutional side. As you can see here, we got good growth in the quarter ending June 26. Again, without any major representatives. So, basically this tells us that we've got some real interesting potential down the road once everybody is in place. I call this our mugshots.
This is our management team. So, basically, just to give a quick highlight here, Jaime Bartushak, our CFO, great background, has done a lot of work on the pharmaceutical side. Myron Holubiak, who's my partner in starting the company, used to be the president of Roche Laboratories. I want to highlight Dr. Myron Czuczman. I should also highlight something else for you here.
We're the only pharma company in America that has two Myrons in our upper management team, as far as I can tell. So, Dr. Czuczman spent 23 years in Buffalo at Roswell Park Comprehensive Cancer Center as the chief of lymphoma/myeloma. He published 180 papers, and he is a lymphoma rock star. He then went, after 23 years there, to Celgene as vice president in charge of worldwide research in lymphoma/myeloma.
After they were acquired by Bristol-Myers Squibb, he didn't want to be with a larger company. We're fortunate that we managed to hire him well before we even did the transaction for LYMPHIR. And anywhere he goes, he's well-known around the world. So, Michael McGuire is in charge of commercial operations, spent 25 years at Hoffmann-La Roche and launched all their major antibiotics. Omar Lansari is our Director of Marketing.
He came to us from Regeneron, where he participated in their major launches. So, one thing I should say about our company, first of all, we have no trainees, we don't have any summer programs, no interns, none of that. We only have professional, highly experienced people with a solid background of success. So, what is CTCL? It's actually part of a subgroup of non-Hodgkin lymphoma that is driven by malignant T cells.
It is an orphan cancer. It basically accounts for about 4% of the non-Hodgkin lymphoma. It's more prevalent in men than it is in women. There are different subtypes of it. Mycosis fungoides is the most common type, followed by Sézary syndrome, and then in other CTCL forms. I started, I tried to describe for you how awful this cancer is.
As you can see here, actually what happens here with this particular cancer is that it gets diagnosed by the dermatologist first. A lot of times it gets mistaken for psoriasis or something else. But then once it enters into a tumor phase, it becomes the province of the oncologist/hematologist. And as you can see at the skin stage, especially when you look at something like T3, the third stage, basically look at those tumors on the face. It's highly disfiguring, and what's characterized by it is extreme itching.
They will itch to the bone. It's that bad. So, this works against malignant T cells. It lowers the T cells in a microenvironment of a cancer cells or Tregs that depletes them. And actually, that's a feature of it that makes it a very. It's very unique compared to the other competitors in the market, which I'll highlight shortly.
The clinical trial that we did that was finished on 302 patients, showed a 36% response rate, very rapid activity within six weeks, lasting skill relief within six and a half months, reduction in skin burden 84.4%, and a durable response of 60%. In terms of side effects, these are all manageable side effects. Capillary leak syndrome is probably the worst one out of the group, but it's very, very manageable and easily identified by the oncologist.
As far as the competition, there are really three drugs in here, but only two are actively promoted. ADCETRIS, which is now a Pfizer drug, basically requires a CD30 biomarker and has peripheral neuropathy as one of its side effects. Poteligeo, which is part of Kyowa Kirin, another Japanese company, and it's more effective in the Sézary syndrome subsegment of that disease.
It acts on the blood rather than skin, and it's got an overall response rate of 21%. Istodax actually was a Celgene product that ultimately Bristol-Myers Squibb acquired as part of the Celgene acquisition. It's not promoted at all. We think everybody will tell you they have significant advantage over the competition and vice versa. We're no different in that regard, but we think we do have some good edges in here that we'll be able to explain to the oncologist.
What we really like about this market is the smallness of it makes it real attractive in terms of penetration. We've identified every treater out there, and basically, as you can see, 10% of the physicians will treat greater than three patients, and then 141 of the physicians diagnose greater than 20 patients.
It's a great market for us to be able to penetrate and work really, really well. 60% of the CTCL patients are concentrated in 10 states. I call it you follow the smile, basically, as I always call it, goes up and around, for the most part. But again, a good concentration makes it great for us to be able to penetrate. We've got nationwide U.S. distribution already with all the three wholesalers.
That's all that's left in this market. Some of you don't know that. What's great about our inventory is we have a five-year expiration date or shelf life. And we've got some ex-U.S. commercialization underway with companies that we don't have to get an approval. It's something similar to what we have here with compassionate use.
You can sell the drug almost at a higher price and not have any approval whatsoever from the governing country. In terms of for growth beyond it, as I mentioned, we had two investigator INDs, one at the University of Minnesota where the LYMPHIR was combined with CAR T. Great data, great investigator at that center, and there's some good work that still remains to come out of there. University of Pittsburgh, the investigator there decided to study LYMPHIR combined with KEYTRUDA in solid tumors.
We're not a solid tumor drug. We're really blood cancers, but solid tumors and endometrial and ovarian cancer, which are extremely difficult to treat. The objective response rate in those two cancers can be in the single digits at times. As you can see here, we had a 33% response rate in endometrial and 24% overall response rate. A small study.
We are working out protocols right now to see what we can do about taking this into a phase II trial. We have great protection here, 12 years of BLA exclusivity plus orphan drug exclusivity, seven years. Two patents pending on the combining it with KEYTRUDA and other ingredients.
We have a very complex proprietary manufacturing scenario for the drug, makes it real hard to penetrate. Quickly on Mino-Lok, because I do not have that much time left. This is an antibiotic lock solution for treating infected catheters, central venous catheters. This is a real problem in patients that have long-term catheters implanted. What happens is the catheter is implanted to the superior vena cava in the heart, and ultimately, over time, they will get infected.
When they get infected, the only standard of care today is that you have to remove and replace two separate surgical procedures, expensive, painful. The patients and the doctors cannot stand this procedure. The Chief of Infectious Disease at MD Anderson, Dr. Issam Raad, invented a special solution, contains minocycline, and basically it penetrates against biofilm, which is what you see here.
This is a bacterial slime that forms on the inner walls of the catheter and a line itself. This drug does not go into man, I should highlight for you. It basically is the line gets locked, and we will show you how it gets administered. All that happens here is that the patient is there in the bed. The nurse will come in, inject the solution into the catheter. The line gets locked, so this solution does not go into the body.
It will reside there for two hours. After two hours, the nurse will come in and aspirate out the contents, flush the line, and the patient will have 22 hours of uninterrupted IV flow. Basically do this five to seven days in a row. That line is completely free of everything, and no need to go through two separate surgical procedures. We did a phase III trial.
We got great results. I can tell you that the P value was 0.0006, as compared to a home brew that the hospitals would mix up. We have provided the data to the FDA. We are in a back and forth with that agency right now, and our goal is to get the best outcome for us, and we should hopefully will have information in the coming months. Halo-Lido is the other drug that is inside of Citius Pharmaceuticals.
This is a hemorrhoid drug, and this came when we basically merged in with Citius when it was public. The reason we kept it is it has nothing to do with the markets that we are in, obviously, is because believe it or not, in the 21st century, there is not a single FDA-approved prescription drug for the treatment of hemorrhoids.
The over-the-counter market has Preparation H and drugs like that, but they are only good for stage 1 hemorrhoids, not two, three, and four, where this would be applicable. We have completed one trial. We are going to go back to the agency. We held up on spending anything for it as we were husbanding our cash for launch of LYMPHIR. With that, this is just a quick financial position. As I highlighted before, $7.1 million worth of revenue. Basically, the gross margin on the drug is 77%.
We own 71% of Citius Oncology. $17 million cash in our balance sheet at the end of June 30th. We think we've got 27.4 million shares outstanding in CTXR and 92.9 million shares outstanding at CTOR. We've got a disconnect here in the sense that the market cap for CTXR, which owns 71% of almost a $100 million market cap company, is only $16 million at tis point.
All this will correct. One thing I should highlight also is that on a financial reporting basis, the results of CTOR will flow down to CTXR. It'll be consolidated with it because of the fact that we own 71% of the company. In terms of what we have today, we've got an approved drug plus a drug in phase III and a great opportunity with the hemorrhoid drug at this point.
I always get asked the question: which company should we invest in? Which is a great question to ask, and my response is always the same, both. They're both great opportunities for either way. I think it's not often that you can find a company at this price level, at this market cap level, that's right about ready to explode in terms of revenue growth down the road. With that, question.
I understand that you believe you should invest in both. I understand why you say that, because you see the positive fundamentals on both sides, right?
Correct. I do.
But what I see as an analyst is the arbitrage opportunity, right?
Right.
I got that, right? Since Citius owns 70% Citius Oncology, but its valuation doesn't reflect 70% of Citius Oncology. So if they're both equally right, I would be better off to buy Citius and pick up that arb along the way.
Right.
All things being equal.
There are great reasons for both of these. So all right, but you just highlighted a great reason for CTXR. I could make the same argument in terms of CTOR as well. So both are great investments. And with that concludes my presentation. I have handouts here for anybody who would like to have them. So I thank you for your attention. And, when you walk out the door, you'll be handed a test.
Thank you.
All right. Thank you.