Okay. Thank you, everybody. Appreciate your attendance here. We look forward to providing you with a detailed overview of, actually, two companies: Citius Pharmaceuticals, which is the parent company, and Citius Oncology. We're going to be making some forward-looking statements. As we advise everybody, please consult either sec.gov or citiuspharma.com, our website, for all the possible information on the company. An informed investor is the best type of investor. With that, just some highlights in terms of the companies. Basically, as I said, we have two companies. Citius Oncology is a subsidiary of Citius Pharmaceuticals. Citius Oncology was formed and started trading publicly in August of 2024 when a SPAC acquired our sub. There was no cash that came with that. As a result, the shares in Citius Oncology are 92% owned by Citius Pharmaceuticals. The symbol for Citius Pharmaceuticals is CTXR.
The symbol for Citius Oncology is CTOR, obviously by the name. Citius Oncology is a company focused in on cancer and has an approved drug for the treatment of cutaneous T-cell lymphoma. That drug is called LYMPHIR. We plan to launch it somewhere in the course of this year. We basically also have Mino-Lok, which is under Citius Pharmaceuticals. That is an antibiotic lock solution. That was really our first drug. We licensed that from MD Anderson. It is for salvaging infected central venous catheters, long-term ones. We have completed a phase three trial. We are now preparing all the data for an interaction with the FDA to determine whether or not they will allow us to file an NDA. We also have a third drug, which is kind of far afield from where we are with the other two drugs because they are very serious drugs.
All of a sudden, I say, "We've got a hemorrhoid drug." Everybody looks at me like, "You have what?" With that, that hemorrhoid drug came with Citius when we merged in. We started out as a private company, merged in with Citius, which was public. We had been funding all the work ourselves up to that point. I should highlight something that some of you may not know, but we're what I call an all-in entrepreneurial company. The reason for that is because we have our own money invested in the company. I have $22.5 million invested directly, not in stock options or anything like that. Marian Halubiak, the other co-founder, has $4 million of his own money in the company. It's a sign of our commitment to the company and also our belief in our technology.
When we merged in with Citius, this hemorrhoid drug was there. We weren't sure what to do with it until we took a good look at the category. Didn't realize that, believe it or not, in the 21st century, there isn't a single FDA drug approved, a prescription drug approved for the treatment of hemorrhoids. You've got the over-the-counter market, which has Preparation H and products like that. In terms of Citius Oncology, as indicated, the lead drug that we have is called LYMPHIR. It's got an orphan indication or will have an orphan indication for stages one through three of cutaneous T-cell lymphoma, otherwise for short, CTCL. With that approval, we got 12 years of BLA exclusivity. This is really the first new systemic treatment in this category since 2018. The market size is about $400 million. That's basically in three drugs.
The interesting thing about this market category is, unlike other markets, you know, when you launch a new product or a new drug, you're taking market share away from everybody. That's not the case here. What will happen will be, because of the way the oncologist treats and practices his treatments, we're going to be adding to the market. The reason being is because none of the drugs are curative, number one. As a result, what that oncologist is attempting to do is to maintain the patient's life as long as possible, plus make them as comfortable as possible. They'll go from one drug to the next depending on the response they get, whether it's from the efficacy side or the side effect side.
We also have a shared management services agreement with the parent company in that the management team for Citius Oncology and Citius Pharmaceuticals is identical. We've done that for the time being because of the fact that it's much more economical for us to be able to do that. Once we start getting volume in place, we'll start to really put in full-time people into those staff roles. To date, we've invested over $90 million into LYMPHIR. $40 million of it was with the outright license agreement that we acquired from Dr. Reddy's of India when they divested it. We've also put in $43 million in development and other pre-commercial efforts. That includes inventory and so forth. Another $5 million went in when the SPAC got created.
With this, what we have now is we've got sufficient inventory to launch a drug, at least a 15-month supply. The drug has a great expiration date. It's basically five years expiry. That's a long, long leg for the drug. That makes it really easy for us to launch this drug. We've got pricing and reimbursement is already well established because of the other drugs that were there. We don't have to conquer any new mountaintops here. As a result, we have a J-C ode. We're also included in the listing for NCCN. Basically, we have also we're putting in an artificial learning system for finding out when potential patient candidates are about to be switched from one drug to another. We're able to be at that doctor's office within a week to two weeks' time of that decision.
We have also had the beginnings of the sales force in terms of the management team. As National Sales Manager, actually, we hired away from Kyowa Kirin, which is a Japanese company here in the United States that launched that last drug. He directed that launch. We have good insight into the market as a result of his presence. All that remains to do now at this point for us is bring the sales force on board, which we have been interviewing for, and start shipping the product to the wholesalers. It is ready to go. It is packaged. It is labeled. It is everything. At the same time, create a patient services hub to take care of the patient needs and execute on our marketing plan. This is what I call our mug shots.
We have a management team that's highly experienced and there are no amateurs. We don't have any management trainees, no interns, none of that in the company. Everybody's a solid professional. Just to highlight real quick, Myron Holubiak , who is the Vice Chair of the company, formerly President of Roche Labs U.S. I'd like to highlight Dr. Myron Czuczman, who came on board with us. He's an oncologist. Dr. Czuczman spent 23 years at Roswell Park in Buffalo as Chief of Lymphoma Myeloma and published 180 papers. He then went to Celgene, where he was the Vice President in charge of lymphoma research worldwide. After Celgene merged in with Bristol Myers, he didn't want to be part of a larger company. We were fortunate in securing Maran coming on board with us.
The rest of the team, all of them have years of experience in the pharma business. Basically, what is CTCL? As I said, it's considered to be incurable. It's a subgroup of non-Hodgkin's lymphoma. It's aggressive. It is an aggressive disease. As the term means, cutaneous, which is skin, it involves the skin heavily. It's more prevalent in men than women and usually appears in people in their 50s and 60s. It accounts for approximately 4% of all non-Hodgkin's lymphoma. The breakdown, as you can see, is a significant percentage is in mycosis fungoides as well as Sézary syndrome. What does it look like? It looks awful. This is the best way to show you here. These patients, as I indicated before, suffer incredibly from severe itching.
As a matter of fact, some of them have made a statement to our people when we've interviewed them. They can deal with the cancer. It's the itching that they can't deal with. Our drug does provide relief from itching, as you can see. Once the topical manifestations of it are awful, and if it gets on a face, it's horribly disfiguring. In terms of its MOA or mechanism of action, it's very unique in a sense that what it does, the highlight of it, is that it eliminates or reduces Tregs in the microenvironment of a cancer cell. That has an important bearing a little bit later when I talk to you about where there may be some further opportunities for this drug combined with other drugs.
In terms of the clinical data that we achieved during our clinical trial, we had a 36% objective response rate, rapid response time, 1.4 months to achieving results, reduced the skin burden by 84.4%, and the response would last about 6.5 months. This is significant. This is great data when it comes to explaining this to the oncologists. Side effect-wise, this has really a low profile when it comes to side effects. I'm sure some of you have probably sat in on cancer drug presentations where the side effects were much worse. Here we have 6% for capillary leak syndrome, 6% infusion reaction, and 0% when it comes to visual impairment. In terms of the opportunities that are outside of cutaneous T-cell lymphoma, I should add cutaneous T-cell lymphoma is about 3,000 patients in the United States annually.
Small market, but there are some bigger opportunities. One would be in a peripheral T-cell lymphoma, which is about four times to six times the size of cutaneous T-cell lymphoma. There are no treatments there at the moment. What we expect to see here, as we've seen in some other market segments, is that there will be off-label use of this drug in that particular indication. We could probably do one small study, publish it, and once that gets out there, then everybody will jump on board. What I want to highlight for you, though, is some exciting work that's occurred at the University of Pittsburgh. Under an investigator IND, the investigator there who was originally an OB-GYN/oncologist decided to look at our drug combined with KEYTRUDA.
The reason being is because of one of the reasons being is because of that side effect profile or the MOAs, I should say. The mechanism of action is that we reduce Tregs. KEYTRUDA is known to increase Tregs. That reduces or reduces somewhat its efficacy profile. If you can bring down those Tregs in KEYTRUDA, you should be able to get an improvement in terms of the overall performance of the drug better. There was an animal trial that was done that got published that showed that the combination effect was better as opposed to each drug by itself. This trial is just about completed at the University of Pittsburgh. We did get some early data that showed some real promise.
We're waiting for the last, I believe there's about five more patients to go, and we'll have the data probably by June or July. Right now, it's looking really, really interesting. We think it's got the basis for moving this into phase two with a 27% objective response rate to 33% clinical benefit ratio. With that, we like the way that our drug is positioned competitively. We think that we can come right into this marketplace. We'll get our fair share of patients. What I want to highlight for you is that the pricing in this category is significant. It's somewhere between $325,000 for a course of therapy, which lasts somewhere around six weeks, to $350,000. This is what the competition looks like. Basically, Adcetris, which is now a Pfizer drug, is one that requires a CD30 test. That places it at a disadvantage.
Poteligeo, which is the Kyowa Kirin drug, is only effective in a small subset. We think we have advantages right here in these two aspects that I mentioned. The other drug, Istodax, which was formerly a Celgene drug acquired by Bristol Myers Squibb, and that drug is totally being milked at the moment and not being promoted. Just to highlight again the clinical benefits here, which I've highlighted before, I'm going to skip through this slide. Basically, in terms of the prescriber base, this is what's really critical here. This has a very small prescriber base. A large treater in this category is somebody that sees three patients a year. We've looked at this data. We've analyzed claims data. We believe that we can now cover this market with 25 representatives in total. It's a combination of sales reps plus medical service liaison reps.
Basically, 427 providers essentially treat three or more patients a year, which is, I'm sure, all of us that are accustomed to looking at numbers from pharma, especially big pharma, these numbers are really, really low. What's interesting is, like everything else, these patients are clustered in what I call the smile. If you draw a line through these from one end to the other to the other side of the United States, it's a definite smile profile. Our ad campaign, which basically is an interpretation of our positioning for the drug, is aim once, strike twice. It's a great creative line for this to be able to highlight the dual mechanism of action for the drug. We think we're just starting to scratch the surface with LYMPHIR. It's got real power to deliver significant value.
The fact of the matter is that 300 patients brings you $100 million in revenue here in this category. This is before anything takes place with any of those additional indications. We do have 12 years of, just to remind everybody, 12 years of BLA exclusivity. We've got this is the first new treatment since 2018. The doctors, the oncologist community, and the patients are waiting there. We've gotten calls. We've had from families of patients wanting to know when is this drug coming to the marketplace. Now I want to move into Mino-Lok. This is the drug that we originally started Citius Pharmaceuticals with. It's an antibiotic lock solution. It basically, it's novel in a sense that there's nothing like this being developed in the market. It's the only one of its kind.
Right now, if a patient's catheter is infected, the only standard of care today is to surgically remove that catheter and replace it with a new one. These catheters are implanted. They go to the superior vena cava in the heart. Basically, it's a procedure that the patients hate because it's extremely painful. It has about a 20% adverse event profile associated with it. What's made this so difficult in terms of coming up with something is hold on. I don't have it here. Okay. What's made this difficult is the fact that there's biofilm that forms on the inner walls of the catheter and the line, extremely difficult to get rid of. What Dr. Issam Raad, the Chief of Infectious Diseases, managed to invent, he created a solution that only has three ingredients: minocycline, sodium EDTA, and alcohol.
With that, the way this gets administered, this is just an overview of what happens with the CBC. Here is the biofilm as it forms. The biofilm has an affinity for the bacteria, has an affinity for plastic. They will propagate very quickly once they are exposed to a bacteria. What Dr. Raad came up with was something really, really unique in the sense that it is so different that it has got an approach that will actually help the patient significantly because of the fact that this drug can be administered very quickly. The way it works is just to show you here. What happens is the nurse will come in and inject a solution into the catheter. The catheter and the line get locked. It does not go into man. It stays within the body. It will sit there for two hours.
At the end of two hours, the nurse will come back in, aspirate out the contents, flush the line, and the patient has 22 hours of uninterrupted IV flow. What Dr. Raad was trying, you do this now five to seven days in a row, and that line is completely cleared, including that biofilm. There is nothing on the market that can take care of that biofilm like this unique combination. Just to go back very quickly here, the market itself is about 500,000 patients out of the 7 million catheters that are inserted. Four million of them are long-term. There is a significant opportunity. We think that this is underreported because if the infection occurs within the hospital in a hospital setting, the hospital will not be reimbursed. We completed a phase III trial. That trial basically showed in 241 patients.
This trial had, unfortunately, a tortured history because of COVID. It slowed everything down for us. Otherwise, we would have been probably on our way to an approval by now. Nevertheless, it was a comparison of our solution to a solution that was specific for the hospitals. Hospitals have an opportunity sometimes when these patients no longer have access points. They try to salvage the catheter by creating their own solution to use. Usually, those solutions contain another antibiotic with whatever else that pharmacist mixes in. They can take a long, long time to work. Basically, the FDA wanted a comparator. We had it. We got a six-week trial. The primary endpoint was time to catheter failure.
The results that we got, I should add that we went to India for the last 25% of the patient population or subject population and managed to finish the trial at that level. Basically, we had really a superior, superior outcome. We hit all our endpoints and basically with a p-value of 0.0006, which is unheard of. We are now in the process of assembling that data. We will be sitting down with the FDA and arguing for filing of an NDA. We will see what happens. We are not sure at this point until we have that interaction. In terms of the regulatory side, the regulatory protection that we have here is significant. We have something known as QIDP or Qualified Infectious Disease Product.
What that means is the FDA, in order to encourage antibiotic research, set up this program where the FDA encouraged us to file for it at the time where the review time for your NDA submission is reduced from 12 months to 6 months, cut in half. At the same time, as we all know, under Hatch Waxman, whenever your drug is approved, you get somewhere around four years plus could be up to five years in terms of extra regulatory protection. With QIDP, you get another five years added to it. That is almost 10 years at this point, 9+ , let's say. That is better than patent protection. The reason it is is because no generic can jump you and come in and do a paragraph four filing against you at that time.
That basically, along with we've got a fast-track designation along with a supplementary protection certificate in the EU, which extends our patent protection there up to five years. With that, I'll move into HaloLido. This is a significant opportunity because of the large number of patients that go to doctors' offices and visits for hemorrhoids. There's nothing there. We think this is a significant opportunity. We've created a cream formulation that's a combination of halobetasol, which is a highly potent, probably the highest potency steroid combined with lidocaine for pain relief. We did a phase II-B trial with 300 patients, five cohorts each. The data looks pretty promising. We're now waiting to get an approval for an FDA meeting to discuss with them a new protocol for a phase III trial.
If we get that protocol, we think it's going to look really good in terms of achieving a result. The objective here is to monetize this drug for our shareholders by basically taking it up to a certain point and then showing that we have efficacy. At that point, sell it off or out-license it to a major partner. In terms of what the profile looks like for both companies, for CTXR, the parent company, as you can see, we have 10.3 million shares outstanding, public float about 9.7 million. CTOR is 71.6 million shares outstanding, of which 92% are owned by the company. The public float is 3.5 million. LYMPHIR is poised to launch in this year. We're out there at this moment raising the funds for the launch of LYMPHIR. It'll take place within CTOR.
One of the reasons why we created the sub was to make sure that we did not have dilution to our CTXR shareholders. Basically, the funds will come into CTOR and we will launch the drug with that raise. As I indicated before, this is one of the few—no other company is going to stand in front of you at this meeting and say that their management team put in $26.5 million of their own money into the company. That just is not going to happen. At the same time, I have to say we have a great management team in the company. Everybody in our team delivers and delivers well, and that is something that all of us are really proud of. With that, we have two minutes. If you have any questions, I will entertain them with the two minutes.
Okay. Since you have no questions, we'll administer the test that we're going to give everybody on this, what I just said. Thank you.