Great. Welcome back, everyone, to another session here at Oppenheimer's 35th Annual Life Sciences Healthcare Conference. I'm Leland Gershell, one of the analysts on the Biotech Equity Research Team, and very happy to be joined now by UroGen, which we have been covering for quite some time and we're very much in favor of. UroGen is working in the area of non-muscle invasive bladder cancer, which is a very large market opportunity. Also has a product on the market for a cancer called upper tract urothelial cancer, where it's been commercializing that product for several years, developing a urology sales force infrastructure here in the US. On behalf of UroGen, we have the company CEO, Liz Barrett, so I will hand the mic over to her, and then if we have time at the end, we can have some Q&A, so please feel free to submit some questions. Thank you.
That sounds great. Thank you, Leland, and thanks for having us, and as we were talking right before we joined the group, you know, we'd love to see our stock start to reflect the opportunity here, and we'll talk more about that right now, but also in the fact that Leland has been a great supporter of ours, and we appreciate his belief in our company as we do as well, so what I'll try to do is run through the slides as quickly as possible so that we do have time for some Q&A. It was working, here we go, it was working earlier. I do think we're in a very unique position when we think about our industry and the biotech industry.
Our company, as Leland says, that we have a small product on the market, Jelmyto, and we have our biggest opportunity that in late-stage development, obviously at the FDA right now, being reviewed with a PDUFA date of June 13th of this year is an exciting time for us. We have an IO pipeline behind it, as you know, non-muscle invasive bladder cancer. We have been treated by immunotherapies for many years, and we have an IO in a CTLA-4 and a TLR7 agonist that we're studying in a phase one study in high-grade non-muscle invasive bladder cancer. We are fortunate at the moment to have a very strong balance sheet and believe with the money that we have today, we can get to profitability.
Our company was actually founded in Israel based off of an unmet need identified by a urologist because they were going through repetitive surgery for patients with low-grade non-muscle invasive bladder cancer, looking for an opportunity. Is there a way to have medicines dwell longer in the cavity? And with that, some chemists in Israel actually developed our technology called our RTGel. It's called RTGel because it's a reverse thermal gel. It's actually liquid when it's cold. As it hits the warm temperature of the body, it turns to a gel and sustained releases medicine over a several-hour time period, disintegrates through normal urine flow, and is excreted through the body, so a very elegant solution to try and do what physicians said they needed, and that's allow medicines to dwell long enough to actually kill the tumors that are in the urothelium.
Our pipeline, at a snapshot, as we talked, as I mentioned in the introduction, we have our one product, which is a rare disease for only 6,000 patients in the US, low-grade upper tract urothelial carcinoma. That's a product in which 6,000 patients get treated by 10,000 urologists. So sort of hard to find. I'll talk more about that in a moment. Our main product, UGN-102, which is at the FDA, as I said today, a much bigger patient population and a much bigger market. That market is about a $5-$6 billion market, and we've said publicly that we expect UGN-102 to be well over a billion-dollar revenue drug for us. And then UGN-301 is our first attempt at moving from a low-grade disease into high-grade disease.
That area is very popular right now, a lot of activity, but unfortunately, these patients don't get cured, and so they need new therapies, and so we have some data that will be coming out this year in that space. As we think about Jelmyto, I mentioned this already, so I won't spend a lot of time on it, a rare disease in which the majority of these patients actually will end up losing their kidney. We're talking about an elderly patient in their 70s and 80s at diagnosis. So being able to keep their kidney is actually very important for these patients. As we know, age alone is an independent factor for reduced kidney function, so anything we can do to maintain the kidney.
And in addition to that, the data that we've seen with Jelmyto, with a 58% complete response rate, an 80% durability at 12 months, and importantly, we have a study that we were following patients, small group of patients, but following patients to get to a median, and we have just published the fact that the median is almost four years. So I think the most important thing about this medicine, as well as the medicine UGN-102 that we'll talk about in a moment, is the ability to provide patients with a longer durability. So therefore, treatment-free survival and their intervals, longer intervals in between these treatments. In addition, we have a registry in which we're gathering real-world evidence.
The good news is that real-world evidence continues to support the clinical study that we did for Jelmyto, and you can see that actually even the complete response rate is actually better in real-world use, and the adverse event profile is also more favorable since launch than we saw that even in the study. We have seen a quarter year-over-year growth, a double-digit growth. We expect Jelmyto to continue to grow. We've talked recently about some headwinds that we faced in 2024 around gross-to-net. I'll talk a little bit more about that in a moment, but important to see that we continue to grow. And when you look at underlying demand, we continue double-digit growth, and underlying demand again offsets somewhat by some challenges with gross-to-net, but we haven't yet shared our 2024 earnings.
We'll do that in the next few weeks, but again, continue to see the growth in this space. As we shift our focus to launching in low-grade, intermediate-risk, non-muscle invasive bladder cancer, UGN-102, very much a transformation of our company to happen this year. It's important to take a look and stop and think about low-grade versus high-grade. That's important because, again, the non-muscle invasive bladder cancer space has gotten very busy, but the majority of those products are in high-grade. We will be, if approved, the first medicine available and approved in the low-grade space, but specifically for a patient considered to be low-grade, intermediate-risk. So again, important to know the differences. A low-grade patient doesn't die from their disease. They don't typically progress. Only a small percentage of these patients progress. Whereas high-grade disease, you do see progression, you do see metastasis.
And so these patients are the ones that are getting treated by BCG and now some of the other new molecules that have come to market. Very strong data, very exciting data for us. You know, we shared the data of Jelmyto just a minute ago, but 80% of the patients in our Envision study, which is our pivotal study, had a complete response rate, and over 80% of those through Kaplan-Meier analysis of durability, duration of response at 12 months post-CR, which is really 15 months from the time that they started treatment. This market, as I mentioned before, a much bigger market than Jelmyto. So for upper tract urothelial carcinoma, about 6,000 patients, you got about 80,000 patients in this market. 60,000 of those were the recurrent patients. That's the patient population that was in our Envision study.
But we also had two other studies that had both recurrent and newly diagnosed. Intermediate risk is defined as patients with multiple tumors. Larger tumors are a history of recurrence. Again, a $5-plus billion market. We also know that these patients find themselves in a frustrating cycle of treatment because they continue to recur. 23% of patients will recur five or more times. 68% will recur two or more times. We have a very robust clinical program, as I mentioned before. In addition to the Envision study, which is our pivotal study at the FDA, we also had a phase 3 study called Atlas, where we were head-to-head against TURBT, and then our phase 2 study, which was the Optima, which had both newly diagnosed and recurrent patient population. In Envision, I mentioned this before, 80% complete response rate.
You can see that progression to high-grade disease was only 2.9%, so very small and actually less than what you see in the peer-reviewed literature. Importantly, so just as important as complete response rate is durability and duration of response. As I mentioned before, 82.3%, but also important to see, you only have very few patients that got out to 15 and 18 months, but you can see that they continue in durability, and these are very, very tight confidence intervals, so we feel very strongly and confident in the data that we've shared. We will be sharing an update in the next few weeks of 18-month data, and so this is 18 months post-CR, so all patients would have reached their 18-month timeframes, or really 21 months from the time of treatment, and we'll be sharing that in the near future.
Importantly, the median duration of response has not been reached, was not reached in our study, and we continue to follow these patients in Envision for five years to get to a median. AEs, importantly here, this is a medicine that provides what I would call expected adverse events. So, you know, of the lower urinary tract symptoms that you would expect to see, very mild to moderate. There were only two serious adverse events in the study, and one was stenosis, and the other one was urinary retention. Both resolved, and there were three deaths in the study, but none related to treatment. Again, not only from an efficacy standpoint, but also from a safety and adverse event, a very manageable profile. I wanted to share with you some data as we look across our program. What's really important is the consistency of the data that we've seen.
And here are our two phase three studies. You can see the 80% in Envision. And then Atlas, you have the ITT population, which includes both recurrent and newly diagnosed. And then what we did is a subgroup analysis to show that the Envision patient population in Atlas, and what does that look like? And here you can see in the box that very, very consistent data, both from a complete response as well as a durability. And importantly, in the median disease-free survival, not reached in either arm. A very important to me, and I always say we don't spend enough time talking about this. We need to spend more time talking about this, but we did some patient-reported outcomes in the Envision study. UNC did a structured questionnaire for patients. And remember, the Envision study, all patients had had a TURBT.
So these were patients who had recurred, and they had had at least one TURBT. And 90% of those patients preferred UGN-102 to a TURBT. Why? They said it had less impact on their activities and responsibilities. There were less bleeding, catheter issues. And again, 90% said they would recommend UGN-102 over a TURBT because they perceived it to be less invasive, less painful, and less time-consuming. Our, as I mentioned before, we're at the FDA during review. Right now, we are anticipating the ODAC to be in the May timeframe. We don't have a final date, but the FDA has consistently said and continues to communicate that we will have an ODAC. We actually think that's a great opportunity for us to present UGN-102 for this patient population. And we are getting your typical IRs, you know, that you get through the FDA.
We've had some site inspections from the FDA, so things are moving forward. I know there's a lot of questions about, you know, are we worried about timing? At this point, we see no reason to think that the timing should be delayed given all the things that are happening in the government as we speak. So we expect, again, the ODAC in May and our PDU for June 13th. We are, you know, in the throes of building our organization for this launch. We had 42 reps last year at this time. We were going to build to 83 reps prior to approval, but we will hold on hiring those until we get closer to the ODAC and the PDUFA date.
But the expectation is we'll have probably double the reps, and we'll have double the number of physicians to call on because UGN-102, as I mentioned before, many more patients, many more doctors. All doctors see these patients. This is sort of their bread and butter. They see these low-grade non-muscle invasive bladder cancer patients. In addition to the sales reps, we have support teams and market access because, as we know, this is a buy-and-bill drug. So we need to have the reimbursement support there, as well as our medical team who is out there and our nurse educators and regional operations manager. So a full complement of an organization to support the physician and the office in getting prepared and using our medicine once it gets approved. We've had some great feedback from physicians.
I know we hear often that urologists or surgeons are really going to stop doing surgery, and physicians are actually very excited about UGN-102 for their patients. They are not struggling with filling their OR time, so they're happy to have an option that can be done in the office by a nurse or an extender. It doesn't even have to be done by the physician. So a lot of excitement, again, around UGN-102, and they see the data that we've shared, and they really believe that it's meaningful and differentiated. So as I leave UGN-102 and move to our earlier pipeline, we have UGN-301, which is zalifrelimab, a CTLA-4 that we licensed in, and we would be the first to actually deliver a checkpoint inhibitor locally. We deliver that in our gel in combination, and we're doing combinations right now.
We shared some data recently at SUO, where it was really a dose finding, so we didn't have any major issues and really focused on what dose we would use going forward. We expect the opportunity to really be in combinatorial therapies. We'll start to share more of that data soon as well, so you'll start to see more around advancing our pipeline here. As we look ahead and what are we working on today, we've often talked about our next generation formulations for both UGN-102 as well as Jelmyto. I think most of you know that we launched our study, UGN-103, first patient dosed back in the October timeframe, and we expect to launch UGN-104, a trial shortly in the first half of this year. Why move to this next generation? Several reasons. You're really from a supply standpoint, a manufacturing.
It is a different product. It is a proprietary mitomycin by a company in Germany called Medac. We have the exclusive rights in our space, and we would combine that with our proprietary technology. Again, we initiated the study. We expect that we will be fully enrolled in UGN-103 this year, and we will look to launch that drug in 2027 with the intention of taking UGN-102 off the market and moving the business to UGN-103, and then the same with Jelmyto and UGN-104, and the great news is we were issued patents for this combination until the end of 2041, so we see that we're building not only our current portfolio, but building lifecycle management behind that as well. As I mentioned before, we're in a very nice financial position.
We announced the end of Q3 with over $250 million in cash, $25 million in revenue for Jelmyto. We do have a great partner in both Pharmakon and RTW, where we have a royalty deal with RTW and a debt deal with Pharmakon. We've drawn down about $125 million of the $200 million with the opportunity post the launch to draw down the $75 million if we need it. Then when I talked earlier about our ability to get to break even and into profitability with what we have today, it does not take into consideration the $75 million. So if we wanted to do something else more in the area, we do have the flexibility to add to the portfolio as well.
So in summary, you know, I want to just talk about the fact that we have unprecedented data in both low-grade upper tract urothelial carcinoma as well as UGN-102. I often talk, I like to use my sort of mantra these days, has been 80, 80, 90. I don't think I've been in oncology for over 30 years. You have an 80% complete response rate, 80% durability, and 90% of the patients prefer our drug to current standard of care. We will continue to focus on building adoption with Jelmyto. We see quarter- over- quarter new physicians writing every quarter, strong balance sheet, next generation pipeline, and we expect to hopefully grow through organic and inorganic opportunities. So with that, I'll stop, and I see Leland has joined us, and maybe we can do a little bit of Q&A. Great. Y
eah, no, thanks so much, Liz.
It was a terrific update. Obviously, you're preparing for the adcom, which, you know, investors are, I guess, focused on. Are there any particular issues that you think are going to crop up given, you know, it is a very strong data set that you've shown with 102?
Yeah, look, we get that question a lot around why an ODAC. And as you know, Leland, having been around for a long time, we've been having conversations with the FDA for many, many years. And their initial concern was around, well, if you delay treatment with a TURBT by three months while you wait to see if it works, are you harming patients?
And so what we've been able to do through our program is demonstrate that no, that if a patient doesn't get a complete response with our drug, they can go on to get a TURBT, and the outcome is the same. So there is no difference in outcome with that. And I think that was important. So we don't hear that so much from the FDA. What we really hear from them is they say three things. One, does Envision provide substantial data because, you know, at the time when we gained agreement with them that a single arm study could be the basis, they said it will be the totality of the data and clinically meaningful. So we believe we met that bar. So that's your first question. Does it provide substantial evidence? The second is around what is the role of Atlas? So how do we interpret Atlas?
Obviously, we only followed patients for 12 months there. We didn't enroll the full set of patients. So what is the role of Atlas? And as they've said, and we've said as well, Atlas is supportive. And that's why I shared the one slide that shows the data, and Atlas is very supportive of the data in Envision. And then lastly, it's around the AE profile. And what's interesting about the adverse events is if you look at Atlas, actually the UGN-102 arm had more AEs than the TURBT arm did. But it's important to look at the AEs. And they were expected. They were very mild to moderate with very few, as I shared, serious adverse events. So that's their last question, around AEs.
So we think given that those are their three questions that they've sort of shared with us, and they didn't share any from an ODAC, this is just what they've been, you know, as we review, these are the things we're looking for. You know, we think that we've met and exceeded, you know, what we would consider to be the bar for approval.
Great. Great. Well, with that, thanks very much, Liz, and thanks to all of you who've tuned in to this session with UroGen. Wish everybody a great rest of the day.
Thanks, Leland. Talk to you soon. T
hanks.