de los Pinos, President and CEO of Aura Biosciences. Now I'll turn it over to Elisabet.
Hello, it is a pleasure to be here and introduce our company. Moving through the legal disclosure. So Aura is a publicly traded oncology company. We have, as you can see in the slides, multiple near-term clinical catalysts. Number one, we have a precision therapy platform, and developing a completely novel class of drugs that we called virus-like drug conjugates. Our lead asset is in phase III stage development, for the treatment of primary uveal melanoma, and we're currently enrolling the phase III, with an FDA SPA agreement that supports registration. With this asset, we're addressing large market opportunities.
Ocular oncology is a group of rare cancers with an overall incidence of more than sixty thousand patients just in the US and Europe. And urologic oncology is a very large unmet medical need, with over five hundred thousand patients a year globally. Both areas have high unmet need, and we believe we can make a difference for these patients. You will see that we have key upcoming catalysts, with clinical data within the next six to twelve months. The first one will be our early phase I data, as we'll expect, and to present in the next few slides.
So if we look at our pipeline, you will see the two therapeutic areas: ocular oncology and urologic oncology. In ocular oncology, with primary uveal melanoma, as I said, we're enrolling the phase III study, and we will present the phase II end of study data in September, as we presented in our last earnings press release. Metastasis to the choroid is the second ocular oncology indication. It doubles the market opportunity, and we're starting a phase II study in the fall, with early data of this study to be presented before year-end. As I said, there's a lot of excitement around bladder cancer.
We will present data in a company-sponsored event in mid-October. The data will be presented in the cohort of non-muscle invasive bladder cancer patients. Now let me introduce you to bel-sar, our lead virus-like drug conjugate. bel-sar is a virus-like particle that's conjugated to over 200 molecules of a light-activatable molecule. The virus-like particle is a non-replicating viral capsid. It has no genetic material, it cannot replicate, it's extremely safe. But it's highly targeted to cancer cells, binding modified heparan sulfate proteoglycans on the surface of cancer cells selectively.
If we look at bel-sar's mechanism of action, in this slide, you can see that it has a dual mechanism, and this is very important. The first mechanism is what we call direct cell killing, and the second is an immune activation. So let me explain how it works. You can inject bel-sar as a VDC in any organ, for example, the eye, and it will not bind any of the normal eye structures that are so important for vision. It will basically bind the virus, the membrane of the cancer cell, because the virus-like particle will bind to the heparan sulfate proteoglycans that are on the surface of the cancer cell membrane.
Once you activate it with infrared light, these light activatable molecules that are carried by the virus-like particle will generate reactive oxygen species, and they are highly cytotoxic, leading to acute necrosis through a mechanism of proimmunogenic cell death. That mechanism leads to the second part, as you can see in the bottom of the slide, with the release of damage-associated molecular patterns, the activation of antigen-presenting cells in a robust CD8 and CD4 T cell response that leads to an immune-mediated tumor cell killing.
So now I will introduce our clinical development and area of focus in ocular oncology. As I said at the beginning, ocular oncology is a large market opportunity. It's a group of rare cancers, all of them in the eye, and all of them treated by the same specialist, ocular oncologist. Overall, they represent more than 66,000 patients just in the US and Europe. They are all life-threatening diseases, especially primary uveal melanoma. Uveal melanoma is a disease that starts in the eye. It starts in the uvea layer of the eye, and it metastasizes outside of the eye into the liver.
The key of this disease is that 80% of the patients are diagnosed early. Patients are diagnosed when basically their disease is an ophthalmic disease. And unfortunately for these patients, while the disease is diagnosed so early, there is no effective treatment, and the only treatment that exists is radiotherapy that leaves patients with blindness... so the goal of ocular oncologists, and really that first discussion is, "Yes, let's prevent metastatic disease, let's treat the disease early," but unfortunately, we have to give away the vision and give the patients long-term irreversible comorbidities.
There's a long period of watchful wait. As you can see in this slide, the majority of the patients, eight thousand of the eleven thousand incidents per year, fall into this early-stage category that are not treated by medical oncologists. They are just treated by ocular oncologists, and the majority of the time, there's a long period of watchful wait because the trade-off is blindness. The disease ultimately, even though a lot of these patients end up being treated with radiotherapy, and despite the fact that they're being blinded, some of these patients will end up metastasizing, and the life expectancy, once it's a metastatic disease, is less than a year.
As I said, what's the frontline treatment option today? Radiotherapy. And radiotherapy is not just external beam radiation. It's the surgical implantation of a metal plaque filled up of iodine seeds. As you can see in the left-hand side of the slide, it is a really barbaric intervention that leaves patients not just with irreversible blindness, but a number of surgeries and comorbidities that are really, really affecting the quality of life for the rest of the life of the patients. In this day and age, it should not be that patients need to decide between blindness and death, and this is what we're trying to change.
We are developing what we think it has the potential to be a complete new standard of care for the frontline treatment of this disease by ocular oncologists. Our drug can be administered in the office. It does not require a surgical intervention. It does not require any radioactive treatment. It basically is an in-office procedure of a suprachoroidal administration and a light activation that takes less than five minutes, and it can all be done by an ocular oncologist in the office. The advantages are that we can have the exact same efficacy as a radioactive treatment, but with the huge benefit of visual acuity preservation, lack of radiation-related morbidity, opportunity to treat early and reduce the risk of metastasis, and with a big improvement in the overall quality of life for these patients.
Now, let me tell you about our clinical data. One of the key events of this year, as you remember from the beginning of my presentation, is that we're gonna present the final data of this study in September. So what I'm going to present to you today is interim data, and very soon, we'll be able to provide the full final data readout. Now, the study, phase II study with Suprachoroidal administration, was a dose escalation and expansion, and it's important to explain the differences between the dose escalation and expansion in terms of dosing. In the phases of escalation, the patients received a very small amount of drug, either one or two injections.
We give these up to three cycles. Every cycle is three injections, so a full therapeutic regimen is nine injections, and this is important because we will be comparing the data in this phase II study between the patients that received the low-dose cohorts, one or two injections, to those that received the therapeutic regimen with nine injections, so that we can see an effect of a dose response and can guide us on what we expect to see in phase III. This is a summary of the interim data on the three key aspects of endpoints that were evaluated in this study.
The first endpoint, tumor control, or the complete cessation of growth in the eye locally. As you can see on the left-hand side, we're looking with an overall majority of the patients at 12 months, not all of them at 12 months, but the majority of them. You can already start to see there's a clear demarcation between the subtherapeutic or patients that received a subtherapeutic regimen to those that received a therapeutic regimen, with 20% of tumor control or cessation of growth in the subtherapeutic, whereas a very high level of tumor control and complete growth arrest when patients are treated with the nine injections or three cycles of therapy.
This would mean nothing if it was not hand in hand with visual acuity preservation and safety, because that's what we have with radiotherapy. The difference here is that we can achieve this high level of cessation of growth with incredible safety and visual acuity preservation. If you look at the middle panel, 90% of the patients in the study preserved vision, and this is really unprecedented because the majority of these patients in the study actually had tumors that were right on key ocular structures, like the fovea or the optic nerve. And despite that delicate location of the tumor, we were able to preserve patients' vision in 90% of the cases.
And if you look at safety, remember I was explaining about radiotherapy having all those comorbidities? With this drug, with bel-sar, we have literally only Grade 1 adverse events, the majority of which resolve even without treatment or with a small amount of topical drops. The fact that we can have such high tumor control with such a safety profile really positions this drug to be the absolute choice for both physicians and patients as a frontline treatment for early-stage disease. Because then they don't have to trade off their vision, they don't have to trade off their quality of life, and they can receive extremely effective treatment.
Here is our phase 3 that's currently enrolling. As I said, it has an FDA SPA agreement, which means that if the study is successful, it will support registration for this disease where there are no drugs yet approved. The study is a two to one to two randomized and masked control study, where we're gonna compare the three cycles of treatment, where I just showed you the data in phase 2, to a sham control, meaning that these patients will not be treated in the sham control unless they progress, and the expectation is that the majority of patients will progress in the sham and will be treated with radiotherapy within the first three to nine months of treatment, and then in the bel-sar arm, as I said, in phase 2, we had very good tumor control.
The expectation is that very few will progress, and that difference between time to tumor progression in the bel-sar treatment arm to the sham will drive the statistics for the primary endpoint. And I will show you in the next slide how this will play out with a log-rank test and a Kaplan-Meier curve. The secondary endpoint will be very similar to the primary, but it will include both events of tumor control and visual acuity failure, which I will show again in the next slide. So here is the phase 2 data comparing the low-dose cohorts with subtherapeutic regimen, as if it was the sham in phase 3, to the high-dose cohorts, as we're gonna be treating these patients the exact same way that we did in phase 2, in phase 3.
And you can see with just 10 patients per arm, there's a very good p-value for the primary endpoint, which is evaluating that time to event, each event being a tumor progression event. You can see that the subtherapeutic patients had a lot of events, meaning that, of course, they were treated with a very small amount of drug. They progressed and met the definition of progression within the first six to nine months, whereas the majority of patients in the bel-sar arm did not progress. In the time to composite endpoint, very similar, but we're adding also events of visual acuity failure.
Again, very few events of visual acuity failure because bel-sar is an extremely safe drug. So the majority of the events are driven, both in the primary and key secondary endpoints, by tumor progression between the two arms. So how to risk this study based on the phase 2 data? Here you can see some of the sensitivity analysis that we've done. What if we were slightly less potent in phase 3? What if the tumor control, instead of 80, was 70 or even 60? And what if in the sham, the patients did not progress as fast as we've seen in phase 2? Those assumptions or risk mitigation strategies are shown here, and what you can see is that the study is powered above 90%, even if the assumptions were half as bad.
If the tumor control was worse and the sham did better, still we're 90% power. So now, moving into the second ocular oncology indication, why is this important? It is important because, first of all, there is a high unmet need, and patients are at the forefront of our company. We know that we have a drug that's shown very high activity in terms of efficacy and safety for melanoma, so we wanted to show if this could be a valuable drug for the treatment of choroidal metastases. The KOLs themselves asked us to treat and to try in this indication because it's seen by the same exact ocular oncologist.
This is an exciting clinical trial for us that we're launching now in the fall, and we expect to have some initial data of probably the first few patients before year-end. This is important because these patients are actually very different type of patients from the melanoma. These are patients with choroidal metastases, meaning breast and lung cancer patients whose metastases go to the eye and now are gonna be able to be treated with something different than radiotherapy that will protect their vision and treat their tumor in the eye.
So with this, we will show multiple things. We will be able to show that bel-sar is not just a drug for melanoma. We would show that bel-sar is a drug for many different types of cancers, and it can be given in the eye safely and treat patients that not only suffer from early melanoma, but also preserve the vision of those patients that, unfortunately, have breast cancer, and now today have to be blinded with radiotherapy. Now, as I said at the beginning, we are not just an ocular oncology company. This class of drugs can really have a big impact across many different types of tumors, and one of them is bladder cancer. Bladder cancer, as you can see here, is not a rare disease, unfortunately.
It affects more than 500,000 patients, and it is one of the most expensive diseases to treat. The good news is that bladder cancer, like the eye, is diagnosed very early, and it is diagnosed before it metastasizes, what we call non-muscle invasive bladder cancer. There is an incredible opportunity to treat these patients with something that will preserve the function of their organ and will be able to actually be treated, like in the eye, with a highly efficient front-line treatment option. Very similar to the eye, this slide will resemble the one that we presented in ocular oncology.
The majority of these patients, as you can see in the orange panel, are diagnosed early in the non-muscle invasive cancer indication and are really only treated with surgery. Unfortunately, the majority of these patients don't have a good performance status, don't tolerate anesthesia and surgery very well. There would be an incredible opportunity if we were able to treat these patients outside of the operating room with something that would not just treat the disease in a way that's targeted, would preserve the function of their organ and would prevent metastatic disease.
So that's the opportunity that we have. Very similar to the opportunity in ocular oncology, we can treat with the goal of having a focal direct tumor cell killing. Really, if you remember that second mechanism of action, which in this particular disease would play a big, big role of stimulating an anti-tumor-specific T cell response, with the possibility of not just avoiding the surgery, but reducing the risk of recurrence. Patients are recurring for more than 10 years despite the current, you know, improvements in the treatment of this disease.
The impact on recurrence is still a big burden to the patient. We could obviously move the patient out of the operating room into the office of the urologist with something that is easy to administer, that does not have a replicating virus, is extremely safe, and can be given as easy as a Botox injection, which is the standard for the urologist practice. This phase I study is currently going to be presented in mid-October. We will be presenting the data of our NMIBC patients, which, as you can see here, is all of Part One, which were patients that had just bel-sar alone, no light activation, but also the patients in Part Two in the NMIBC cohort.
And what's important for this study is that we're looking at the feasibility of administration. It's a window of opportunity study, meaning that the drug is given before the standard of care, which is surgery, but then the surgery is performed, so we have histopathological assessment of the mechanism of action. This is really important because it's the first time that we can have a real human data of how the drug works in the setting of bladder cancer. So this is one patient that was treated in this light-activated cohort.
This patient was publicly announced at the end of last year, and it's an example of what the data we're gonna be presenting. So in this particular case, this patient, as I said, window of opportunity, was treated before the surgery. So day one, there was a small biopsy taken to confirm it was urothelial carcinoma in this patient. The drug was injected into the base of the tumor. On day two, there was a light activation, which literally takes five minutes, and it's done under local anesthesia, no need for operating room. And then the patient went back, and after seven days, that's when the surgery was performed, which would have been performed to remove his lesion.
The surprise of the urologist was that when the patient came back to perform that surgery, there was no tumor. No visual tumor was seen. However, the pathology was taken. It was all of the where the tumor used to be. 12 blocks were performed so that we could have a real proof histopathological assessment of the response to the tumor, and what we saw, which was really a fantastic evaluation, was that before, it was clearly a carcinoma, as you can see on the left-hand side, and after just seven days, with a single drop of our drug, we had complete response, with no presence of a single cancer cell, all necrosis, and what you can see here on the areas of necrotic, which are these pink areas without nuclei, you can see around it all this lymphocytic infiltrate, showing that there was a clear immune response.
So again, a clear proof of concept that with just a tiny drop of drug, we were able to have a complete response. So the company highlights what's to come. Ocular oncology, as I said, primary uveal melanoma, global phase III enrolling, phase II final data to be presented in September. Metastasis to the choroid, second ocular oncology indication, phase II study starting in the fall, with potential early data before year-end. And bladder cancer, first time we're gonna be presenting NMIBC data for this disease and for the use of our drug in this particular indication.
It's gonna be mid-October in a company-sponsored event. The company has a very strong cash position. We're expected to be able to fund operations until the second half of 2026, and we have an incredibly experienced leadership team. Thank you all for your attention today.
Thank you, Elisabet, for taking the time to present today, and thank you to everyone joining in to listen to the presentation. Have a great day!