Citius Pharmaceuticals Inc. CommonCTXR
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Citius Pharmaceuticals Inc. Common H.C. Wainwright 28th Annual Global Investment Conference

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Transcript

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R.K. SwayampakulaSenior Biotech Analyst

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.

Leonard MazurCEO

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.

Leonard MazurCEO

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.

Leonard MazurCEO

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.

Leonard MazurCEO

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.

Leonard MazurCEO

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 Citius Oncology as the sub and CTXR as the parent. As you can see here, LYMPHIR is the asset that Citius Oncology 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.

Leonard MazurCEO

The over-the-counter market has Preparation H and drugs like that which are good for stage 1 hemorrhoids, but not 2, 3, and 4. 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.

Leonard MazurCEO

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 1 through 3 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.

Leonard MazurCEO

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.

Leonard MazurCEO

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.

Leonard MazurCEO

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.

Leonard MazurCEO

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 Pharmaceuticals, 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.

Leonard MazurCEO

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.

Leonard MazurCEO

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 6 weeks to response.

Leonard MazurCEO

Lasting response, about 6 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 3 drugs basically. 2 of them are promoted. ADCETRIS, which is a Pfizer drug, is promoted. Proligio, 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.

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