Good afternoon. My name is R.K. I am a senior biotech analyst here at H.C. Wainwright, and our next presentation is from Leonard Mazur, who is the CEO of Citius Pharmaceuticals. Just about a year ago, Citius launched LYMPHIR. To talk about LYMPHIR and the story of Citius, I have Leonard here. Go ahead.
Okay. Thank you for the introduction, R.K., and it is a real pleasure for me to be here, and I thank all of you for taking the time to be with us, all of you here in person, and from what I understand, we also have a group online listening in. With that, let me get started here. First of all, as you see, since I am going to be making forward-looking statements, here is this beautiful statement that you must read, especially if you have difficulty falling asleep in the evening. Start at the beginning, go to the end. Nevertheless, it is important that all investors are informed investors, so sec.gov as well as citiuspharma.com have all the information on the company, all our filings, everything is there for everybody to analyze.
Before I get started here, I just need to give you a historical background very quickly in terms of the fact that we have two companies here, Citius Pharmaceuticals, which is the parent company, and Citius Oncology, which is a subsidiary company. The parent company got started in 2014. Myself and Myron Holubiak, used to be the president of Roche Labs, started the company. We licensed a drug from MD Anderson, called Mino-Lok, that sterilizes infected central venous catheters. We were private for a number of years, as you see up there. We funded the company ourselves. The numbers that you hear from me, you are not going to hear anybody else in this entire meeting say to you, and that is that I have $22.5 million invested directly in the company. Myron Holubiak has $4 million invested directly in the company. That is direct.
That is not stock options, that is direct. We went along and we went public by merging in with a company called Citius, and that gave us a drug called Halo-Lido, which is a hemorrhoid drug that you will hear about. Then basically, ultimately, we raised a significant amount of capital back in 2021 when everything was really going well for all the biotech markets. That enabled us then to acquire a license on a cancer drug called LYMPHIR, which we acquired from Dr. Reddy's of India. As a result, we put the cancer drug into a subsidiary company, Citius Oncology Inc. Ultimately, that subsidiary company was acquired by a SPAC to enable us to go public right away so that we could have a Nasdaq listing.
The reason we did all this is because we wanted to try and minimize the dilution for the Citius Pharma holders. We knew that the funding that would take place to launch LYMPHIR after an approval. With that, we have CTOR as the sub and CTXR as the parent. As you can see here, LYMPHIR is the asset that CTOR has. It is an approved FDA drug for the treatment of cutaneous T-cell lymphoma that you hear about.
Mino-Lok is in phase III. We completed a clinical trial. We are in discussions with, prolonged discussions I should say, with the FDA. We are working our way through that. Hopefully, we will get through that quickly. Halo-Lido is a hemorrhoid drug that Citius Pharmaceuticals had. We took a good look at it. 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 which are good for stage one hemorrhoids, but not two, three, and four. With that, let me get into LYMPHIR quickly for you here. LYMPHIR is, and Citius Oncology is basically, we are a company commercializing innovative targeted oncology treatments. Citius Pharma owns 71% of Citius Pharmaceuticals. We have a shared management services agreement between the two companies. That is important because that really minimizes the expenses in a lot of ways. The management team that is in place for Citius Pharmaceuticals is the team that is managing Citius Oncology as well. The market size for our drug is about $400 million. We got rights to everything except India, Japan, and certain parts of Asia. We do have some investigator INDs that you will hear about shortly.
In terms of our CTCL option and the drug, as you can see it here, it is an IL-2 receptor-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory stages one through three CTCL after at least one prior systemic treatment. We do have commercial supply basically established across the U.S. now. Early adoption that you hear about, as well as broad payer access and some international access. In terms of the early traction, and I need to point this out, that this is early. At the end of December, we basically shipped product to wholesalers to make sure that we could get the pipeline filled correctly. We launched with two people on the road. I need to highlight that for everybody because the results are incredible actually when you think about it. The full sales force just came on board.
29 people came on board just a month ago, basically. We have 21 commercial reps as well as eight medical science liaison representatives. Those are representatives that can talk about unapproved indications under FDA guidelines. They just hit the field basically two weeks ago, and we are using EVERSANA, which is a well-known provider to the pharma industry of various services, including shipping, billing, invoicing, and providing us with the sales force. The sales force is exclusive to us 100%. They do not work for anybody else. They are paid by EVERSANA, but basically they carry a Citius Oncology business card. They are full-time, and we expect good results out of them. With this kind of approach, what we did just here with a limited number of people, $7.1 million in volume.
More interestingly is that 44 institutions, just about on their own, ordered the product out of the wholesaler in this timeframe. We have 135 health plans have coverage now, and we have 100% of all the lives are covered. We know that we are getting good adoption, because we can tell from quarter to quarter what is going on here. As you can see here for the quarter ending March 2026, where we were in terms of the number of vials as opposed to the quarter ended in June 30th of 2026. Then significantly in July, we had one of our highest months ever in terms of orders of vials. This is without the full complement of people out there. That is just starting. We expect the full impact of those people fourth quarter, first quarter.
Fourth quarter or calendar quarter of 2026 to first quarter of 2027, you will start to see the full impact here. As we all know, all of us that are experienced in pharmaceuticals, pharmaceutical launches, generally speaking, are a little bit choppy in the beginning like this is. There is no denying that. The numbers are the numbers. But ultimately, it catches up, and then you start getting momentum and growth. This is the management team. I like to call this our mugshots. Basically, just to cover everybody real quickly here, Myron Holubiak, who is the Executive Vice Chairman of the company, former President of Roche Labs U.S. I would like to highlight Dr. Myron Czuczman. I just want to highlight something else. We are the only pharmaceutical company in America that has two Myrons in their top management team. With that, we have Dr. Myron Czuczman.
Dr. Czuczman spent 23 years at Roswell Park in Buffalo as the Chief of Lymphoma/Myeloma. Most importantly, published 180 papers. He is a rock star in his field. Everybody knows him on a global basis. He has done a great job for us in terms of his presence and what he represents to the overall oncology community, especially in lymphoma arena. Mike McGuire is in charge of our commercial operations. 25 years at Hoffmann-La Roche, launched all their major antibiotics. Highly experienced in terms of especially launching in the hospitals. Omar Ansari joined us from Regeneron, where he participated on their major launches for their drugs. With that, what is CTCL? It is actually a subgroup of non-Hodgkin's lymphoma. It is an aggressive cancer. This is not a pleasant cancer for these patients to have. It is an orphan cancer.
There is a lot of quality of life issues associated with this cancer, including severe pain, pruritus, skin lesions, disfigurement, and all that. I will show that to you shortly. The subtypes of this cancer are mycosis fungoides, which is the majority of it, followed by Sézary syndrome. It accounts for about 4% of all non-Hodgkin's lymphoma. It is more prevalent in men than women and usually appears in patients in their 50s and early 60s. As I start to say, this is an awful cancer, and if you look at it here, especially if you look at when it enters into the third stage, it is disfiguring. Not only that, but the itching aspects of this are awful because these patients will scratch themselves to the bone at times. It is that severe. We do provide relief from that itching side.
This is a cancer that only affects 3,000 people in the U.S. annually, and there is not that many treatment options for this. The MOA that we have, the mechanism of action, is very unique. We target the IL-2 receptor, working against both malignant T- cells and also as an immunotherapy against Tregs. What really makes our drug really interesting is that we basically deplete the Tregs on a transitory basis. That is an important MOA as it will apply to later on when I show you what it can mean in terms of being combined with other drugs. We think because of its uniqueness, it has a very unique place in the marketplace. We ran a clinical trial, basically where we had 302 outcomes. 36% was the objective response rate. Very rapid activity within six weeks to response.
Lasting response, about six and a half months. 84% skin reduction and then a durable response lasting at least in the 60% range. In terms of side effects, these are side effects that all oncologists are very familiar with and we believe can be managed appropriately. In terms of the competition in the market, it is three drugs basically. Two of them are promoted. ADCETRIS, which is a Pfizer drug, is promoted. Poteligeo, which is Kyowa Kirin, is promoted. The market itself is $400, probably now growing to $500 million. Istodax is a former Celgene drug that was acquired by Bristol Myers. They are not promoting it. They are milking the drug. We do have advantages over the competition, and we think that we will be able to penetrate this market in a very significant fashion. As far as what I like about this market, its smallness.
We like small markets that have high value that, like this one has, basically, as you can see, 10% of the providers in here treat three or more patients, not a week, not a month, but a year. Then about another 141 doctor accounts treat greater than 20 patients a year. In terms of concentration, as you can see, it follows what I call kind of the old We used to call this the smile. It is not really a smile, but it is a smile in a way, and that is 60% of the patients are concentrated in about 10 states. This makes it a great market for us to be able to penetrate with the number of people that we have. We have got distribution and good channel access right across the board. There are only three wholesalers left in the U.S. anymore.
All three wholesalers have carried this. Here is the great part about this. This does not have managed care rebates or anything like that. The reason being is because it is a hospital drug, and there are no managed care rebates associated with that. Our gross margin, even with a 10% royalty that we have to pay, is still in the 77% range, which is a great gross margin for us to have.
We have got payer access across the board, and we have got plenty of inventory. This drug has a five-year expiration date, makes it even more attractive. As far as outside the U.S., we will follow a program outside the U.S. that is similar to what we have in the U.S., which is compassionate use, which allows us to penetrate certain markets without having to file an approval with the countries and greatly moderate your price in that.
Now, I mentioned the fact that we also have investigator IITs. The important ones, the two are, one is at the University of Pittsburgh, which I want to focus in on first. There, that investigator chose to look at our drug, LYMPHIR, combined with KEYTRUDA. The reason he did is because of the fact that we lower the Tregs in that microenvironment of a cancer cell, and KEYTRUDA has the opposite effect. It increases Tregs. In order to make KEYTRUDA more effective, he thought he would combine it with LYMPHIR, and basically, he chose to study two very difficult cancers. He went after, first of all, we're only indicated in blood cancers in reality, but he went after solid tumors in ovarian and endometrial cancer. Endometrial cancer has an objective response rate in the low single digits. We had a 36% response rate in this.
What I can just relate, one patient, the very first patient that was put on this drug was headed to hospice to die. She had gone through all the treatments, including KEYTRUDA. They were going to ship her off. They decided to put her on the combo. 18 months later, she's still alive and doing well and thriving. Now, you can't go by one patient, obviously. Nevertheless, the 36% tells us something. We had a great response rate overall. The other investigator IIT that's underway at the University of Minnesota, Dr. Bachanova, a well-known investigator, is looking at LYMPHIR combined with CAR T, another breakthrough cancer treatment, and we'll be getting more data out of that. Our plan right now is we're going to look very carefully at, especially at the Pittsburgh data and see if we have an opportunity for a phase II follow-up.
In terms of our drug, Mino-Lok, just to give you a quick profile there. This is, as I said, it's a drug that, this is a unique drug. There's nothing like this on the market. It sterilizes infected central venous catheters. The standard of care today for central venous catheters is to do two separate surgical procedures, remove the catheter and replace it. The catheter is usually placed in the heart area, right to the superior vena cava.
Basically, it has to be, I always like to say, it has to be ripped out because that's what it feels like to the patient. It's an extremely painful procedure. And then also it's got to be surgically re-implanted. So two separate surgical procedures. Dr. Issam Raad at The University of Texas MD Anderson in Texas invented a special solution that basically contains minocycline, sodium EDTA, and alcohol. What it'll do, it will eliminate biofilm.
Biofilm is the bacterial slime that forms on the inner walls of the catheter, and basically, it makes it extremely difficult to sterilize. Our solution will eliminate the biofilm. There are about four, at least somewhere around 400,000- 500,000 patients that basically get infected. We think this is a $1 billion market opportunity here in the U.S. and another $1 billion outside the U.S. If you take a look at how this is administered very easily, the nurse comes in, injects the solution into the catheter. The line gets locked. This drug does not go into man, which makes it even more unique. All it's designed to do is sterilize the line and the catheter. So you put the solution in for two hours. At the end of two hours, you aspirate out the contents, flush the line, and the patient has 22 hours of uninterrupted IV flow.
That's really important. They do this five to seven days in a row, and that line is completely sterilized of everything. I'm going to basically zip through this very quickly because we have got about a minute and a half left. With that, let me just quickly cover Halo-Lido. As I said, this drug is unique in a sense it's the only one of its kind that would be on the market once it's approved. Our reason for holding on to this is it's a formula that contains halobetasol plus lidocaine. We think it can work really well in the treatment of hemorrhoids. We think it's a big opportunity, but it's not for us. It's a primary care marketplace, and with that, we will probably, once we show efficacy, we'll out-license it or sell it off.
Basically, as far as I've covered these numbers before, but we've got, just to paraphrase again, $7.1 million in terms of revenue over this nine-month period. Actually, it's less than that when you really think about it, since this was at the end of December. 77% gross margin, which is really great. 71% ownership. Here we have a disconnect, by the way. The market cap of Citius Oncology is about $100 million. The market cap of the 71% owner is about $18 million or less. I'm always asked the question, which one is the best buy? I say both of them. They're equally a great buy. With that, we have about 20 seconds left for any questions.
Okay. I have a couple of questions here.
Sure.
This is on LYMPHIR. As you stated, LYMPHIR adoption did grow in the June quarter.