presentation is from Fennec Pharmaceuticals, and we have Adrian Haigh, the CEO.
Thanks. Morning, everybody. Just a safe harbor statement. Just a bit of background on me first of all. I've been a board director of Fennec for almost 10 years. Gave up the day job where I was head of P- of PTC International back in January. Spent six months retired, but joined full-time as Chief Operating Officer in August of this year. So Fennec is a commercial-stage pharmaceutical company. We've got one asset, which is PEDMARK, which is a specially formulated solution of sodium thiosulfate, indicated to prevent cisplatin-induced hearing loss in pediatric patients. We have an Orange Book patent exclusivity in the U.S. until 2039 on the formulations. We have seven years law and drug exclusivity in the U.S., and we have a PUMA, a Pediatric Use Marketing Authorization, in Europe.
We launched commercially in the US in October of last year, and we expect to launch in Europe in June of next year. The reason for that is we had some CRLs in the US with a third-party contract manufacturer. We had to move contract manufacturer. That delayed the launch in Europe, but we're on schedule to commercially launch in Europe in middle of next year. We are currently evaluating our commercialization options for Europe. Do we do it ourselves, or do we license out? We'll make that decision early next year, I would say. So a little bit about the clinical data. Our approval is based on statistically significant results from two clinical trials, two pivotal clinical trials. The first one was essentially done in Europe and the rest of the world in a very homogeneous population, hepatoblastoma, non-metastatic disease.
The second study was largely conducted in the US by the Children's Oncology Group, looking at a very heterogeneous tumor-type population. It was all comers. This study was just powered to show hearing loss alone. You can see that in terms of preventing hearing loss, you get a 50% reduction in hearing loss in both studies, highly statistically significant. And also, what we don't show on the graph is that those patients that did get hearing loss, it's significantly less in the PEDMARK treated group. Acceptable side effect profile, nothing really significant. Patients need to be managed with anti-nausea treatments because you're giving obviously quite a high amount of sodium, which causes vomiting, as does cisplatin. So a couple of words about cisplatin. It's been around since 1979. It is the gold standard treatment for many tumors still.
Many people have said to us, "You know, how long is cisplatin going to be around?" They were saying it 10 years ago when I first joined the board. The situation is no different. It remains the mainstay of treatment, particularly in pediatric cancers, and particularly in the pediatric cancers that we've listed here, where you see cure rates in excess of 85%. So it's absolutely devastating for a child to be cured of their pediatric cancer, to have a full life expectancy ahead of them, but we have their life destroyed because they're profoundly deaf. PEDMARK prevents that. So in terms of the target population, and this is looking at the pediatric cancer market only, so right up to the age of 18, you can see it's roughly the same in the U.S. and in Europe.
Our label in both the U.S. and Europe is for localized metastatic cancer. Sorry, localized, not metastatic cancer. So... And that accounts for about 70% of the population. Now, I've got quite a few slides on the issue of ototoxicity, and I'll rattle through those fairly quickly. So what we see here is high-frequency hearing loss caused by cisplatin. It occurs after the first dose. It's bilateral, it's progressive. Importantly, it can be accompanied by tinnitus, and it's more evident, more dramatic in younger patients where they haven't got full development of speech. And that's quite logical. So although you've got hearing loss, you, if you can speak, you can guess what a patient's saying. Okay, but the hearing loss is still there, and tinnitus is a major issue, particularly in the older patients.
This just shows that it, how it develops. The blue line at the top is pre-treatment, and you can see, you know, the black line is the first dose, and the hearing loss gets progressively worse dose after dose. So, it goes without saying that the consequence of hearing loss are dramatic. People are held back in school. They don't have relationships. There's a high association of depression with hearing loss. You know, there are developmental delays. It goes on and on and on. And because of this, the feedback from the companies that are developing our HTA dossiers in Europe is very positive. They feel that they're able to make a strong justification for a reasonably high price because the health services will avoid paying for the dramatic consequences of hearing loss.
So it's, it's common, but it's not always followed. Oncologists, as many of you know, prefer to treat the tumor and not the patient. So, so what? The patient survived, they've got a bit of hearing loss, at least we've cured the patient. So there's a real need for ongoing monitoring here. And this just shows, you know, the impact here of children being held back in school if you're deaf. So there's a dramatic consequence of hearing loss. And until now, there's been no preventative treatment, so patients that are... If they are treated, they have to have hearing aids. They have frequency modulation, so they have a loudspeaker in front of them, and they sit at the front of the class. Cochlear implants are very common, which are expensive, don't last for long, and obviously, there's all the speech therapy.
So our commercial strategy is fairly obvious. It's to establish PEDMARK as the treatment to prevent cisplatin-induced hearing loss. The value proposition here is, as I said, we're the only treatment that's approved by Europe and the FDA. Dramatic clinical results with a 50% reduction in hearing loss. We're the only company in this space with a commercially available product. There are other companies that are at a very early stage of development, but we don't see any threats in the near-term horizon. We are a unique formulation, so there's virtually no excipients in this product. We're designed to be rapidly infused within 15 minutes, 6 hours after the cisplatin chemotherapy has done its job. Cisplatin has a very short half-life. 2 hours after the cisplatin infusion has been given, there's virtually none left.
It's done its tumor damage. Unfortunately, it is retained within the inner ear, and it, if it's left there, it damages the inner ear. Our PEDMARK binds to the cisplatin, inactivates it, and prevents further damage. Importantly, in April of this year in the U.S., we got endorsement by the NCCN Adolescent and Young Adults group with a Category Two recommendation, so that means it can be fully funded, and we'll go on to talk about that in a minute. But it's an important group of 15- to 39-year-olds. So as I said, as I said, this is the, this is the NCCN recommendation, and we're allowed to state on our promotional materials that it's recommended for adolescents and young adults by NCCN. The label in the U.S. is for pediatric patients.
There's no specified age, and as many of you know, adolescents and young, young adults are treated using pediatric protocols. I was speaking to a doctor in Atlanta, the Children's Oncology Group meeting, back in September, and he told me that he was treating a 34-year-old with a medulloblastoma on the pediatric ward, and that is common. So we see this as a real opportunity. This is data showing the incidence. It's 4% of all cancers. You can see the common tumor types there in the AYA population. There is an 85% cure rate, so it's important to preserve hearing because these folks will go on to have a normal life. And there's recognition there, the little quote at the bottom from a Lancet in the...
Sorry, a paper in The Lancet, which highlights the issue of hearing loss and tinnitus in this population. So what are we doing? You know, we've launched in the U.S. We have realigned our commercial medical organization to focus now on the AYA population. This is done through medical affairs. Obviously, we can't go out and promote directly. We have just recently signed, I think it's now seven agreements with group purchasing organizations, so we have group purchasing organization endorsement. We're just signing up, concluding an agreement with a specialty pharmacy, which will deliver to the home, to infusion centers, or we'll do a white bag delivery to the hospitals and charge Medicare, Medicaid, or the insurance companies directly. And we have a whole access support program and strong relationships with the patient advocacy groups. We've just recently completely reorganized our sales team.
We've hired... We're now at full strength. When I took over, where there were a large number of vacancies. We've now hired a group of people that have real experience in selling into the community oncology centers. This is just the US pay landscape. There are 500 pediatric hospitals, but 80% of the use is in 200 centers, and here they are scattered across the US. In terms of the coverage, it's roughly 50/50 covered by commercial insurance or Medicaid, and we have a J-code in the US so they can buy and bill. We have a patient support organization called Fennec HEARS, which is, you know, standard thing, where the patients can get help with financial support, product support, co-pay assistance, et cetera, et cetera.
We have strong relationships with, you know, all the professional organizations and all the patient organizations. And then just final slide showing the capital structure and the financial information. Almost 27 million shares outstanding. We've got cash of about $12 million in the bank now. Year-to-date revenues are $11.5 million, so we're getting close to the breakeven point. We have debt of $26 million, and those are the three major shareholders. And that's it. Thank you. I think plenty of time for questions if there are any.
If you have a question, just raise your hand and I'll bring the mic around.
So is there a need for a label extension in the U.S. for adult patients? And, currently-
I think-
It's most pediatric.
Yeah. If we were to go for a label expansion into adult patients, because the hearing loss is not as easily detectable in adult patients because of what I said earlier on, we would need a very large study. And we haven't got the resources to do that study right now. I think we, with the label that we have, which says pediatric patients in the U.S., and the fact that we have NCCN endorsement up to the age of 39, you know, if we have... You know, we can handle that group through the medical affairs organization, not through direct promotion. But we're already seeing significant interest, and we have orders from that group already.
We switched focus in October through the medical affairs group, and we already have orders in the community for that target population. So I'm very pleased with the results that we've got.
Any other questions?
Do you have any color on Regeneron's plan for the former Decibel sodium thiosulfate program?
Where it's injected into the ear? I mean, it's very, very early. It's gonna take a long, long time to do the studies. So we don't see that as a threat at all.
Thanks. Yeah, I was curious, have you disclosed any, you know, figures regarding the potential or commercial potential in Europe, or is it-?
We haven't disclosed any figures specifically with respect to Europe. I mean, what I would say is, you saw from the slides that there's roughly the same number of patients. If you dive into the German NUB paperwork on the internet, I'm sure you can find the price that we have, which is actually the US price plus VAT in Germany. So the price that we expect to sell at in Germany is EUR 13,500 per vial. The dose varies depending on the age of the patient and tumor type, because it's weight-based dosing, so you can use anything between 10 and 50 vials per patient if you've got a, a, a...
The German Pediatric Oncology and Hematology Society came back to us and said, "There's no way we're paying $1 million for a testicular cancer patient." So we expect that we will negotiate a cap in Germany and in most other countries in Europe. And you know, I think that cap will be around $100,000 per patient, maybe $150,000 per patient in some countries, which I think is, you know, it gives us a very viable product.
Thanks. Any other questions?
Thank you.