My name is Klaus Sindahl. I'm Head of Investor Relations at Hansa Biopharma since four years back. I'm very happy to see this many people in the room today. Yeah, just need to show you this forward-looking statement, as always. For those of you who are not very familiar with the Hansa Biopharma, then we are a Swedish commercial-stage biotechnology company based in Lund. We are around 160 employees, and we have operations not only here in Europe, but also we're starting to build up in the U.S. We have a broad pipeline across a number of indication areas, mainly within transplantation and autoimmune indications, but we're also starting to explore new opportunities such as oncology and gene therapy. We're also advancing our second-generation enzymes, and I'll get back to that.
Our technology has been validated in three indication areas already. I mean, first and foremost, of course, with the conditional approval in Europe, and also the market access, not at least. I mean, we have now obtained market access in 12 markets, and most exciting, of course, is that the Big Five has actually been secured, Spain very recently. That's two-thirds of all kidney transplantations, which are covered in those markets. We've also seen proof of concept in the first autoimmune indication, anti-GBM, which also validates our technology. Finally, we have now established three partnerships in gene therapy, which tells something about the excitement in this space. We have actually, we are entering the clinic now with Sarepta in Duchenne muscular dystrophy.
We have SEK 1.3 billion in cash, and we're financed through 2025. We are listed here on Nasdaq in Stockholm, and we have 20,000 shareholders. Going back to why the company was founded or the technology which actually makes us be in the place we are in today, it's our IgG cleaving enzyme technology called Imlifidase. That's the first generation. It's themed from bacteria, Streptococcus pyogenes. It's a human pathogen, and what it does is it very fast and effectively cleaves IgG. Basically, from a 15-minute infusion, you can see here to the right-hand side of the slide, that IgG, which is 80% of your immune system, will basically be inactivated.
In a few hours, so two to six hours, it's knocked down, and it will stay down for five to seven days before it gradually starts to bounce back. That can be relevant in situations such as to enable kidney transplantation or to stop an immune attack in an autoimmune indication. This is what we are building the company on. We have a very exciting clinical pipeline. As you can see, we actually have seven programs in clinical phase, which is rather unique for a company of this size. We have three phase III programs also. First and foremost, we are running the post-approval study in Europe, which should be done 2025 in 50 patients. This has been run in parallel with the commercialization in Europe.
We're also running a U.S. ConfIdeS study, which is a pivotal study in the U.S., in kidney transplantation in 64 patients. We have just enrolled more than 64 patients, but we will over-enroll this study to allow for randomization to be complete by the end of this year. Thirdly, anti-GBM is a study where we have, or a phase III study we have just commenced. We're still waiting for the first patient to be dosed. We would like the Hansa Biopharma story to be perceived as a platform story. I mean, we are basically what you can interpret as a pipeline in a product. There's broad applicability with our compound, these antibody-cleaving enzymes, and that's what we try to illustrate here.
In the middle, in the center, you have our technology, and that has broad applicability across those four indication areas, which we have actually established franchises around. Autoimmune indications, transplantation, new therapies, oncology, and gene therapy. We have a number of programs. That's what we try to illustrate with the colored hexagons. There are several opportunities in the outer circles, which we can also pursue. Also from a technology point of view, we can actually advance our technology quite a bit. Imlifidase is in the center, but we can also pursue collaborations on combination therapy, such as Idenix. We can also pursue our next-generation enzymes, which will open up new spaces within the chronic indications. I'll enter into kidney transplantation, where we have the conditional approval in Europe.
Imlifidase or IDEFIRIX, which is the commercial name, got conditional approval in kidney transplantation for incompatible, highly sensitized kidney transplant patients in deceased donors first and foremost. That represents a market of 10%-15% of the patients on the wait list. In the case with Europe, there's approximately 80,000-100,000 patients on the wait list. 10%-15% of those are regarded as highly sensitized, which means that, I mean, you know, 2,000-3,000 patients would, you know, be an addressable market for us in Europe alone, as it's only one in four or one in five who actually get transplanted annually, even though there's 100,000 on the wait list. The conditional approval was obtained on...
based on four phase II studies with 100% efficacy and good safety data. That's why you can obtain an approval based on phase II data. when it comes to the commercialization, as I mentioned in the beginning, we have now obtained market access in 12 markets in Europe, at a list price of around SEK 3 million, which is a price which resonates well with the healthcare systems, because the alternative is the cost of dialysis. Dialysis is roughly SEK 1 million on an annual basis. That's why we have found a good price point there.
We have now established market access in these 12 markets, and in particular, it's the five markets, which is important, of course, because that's two-thirds of all transplantations. We have an early access in France, but we are working to of course, get full access, and more recently, I mentioned in Spain. With the commercialization, we have also started to see the first few patient cases being published. This is, of course, not something Hansa can do and promote, but we can, of course, reference these cases, and there are some very interesting cases out there. We had a 29-year-old lady in Holland, which got transplanted very recently. She was born with kidney disease and had 2 failed transplantations since 2016, where she's been on dialysis.
She was transplanted and is doing well today. We also have a 54-year-old guy from Barcelona who has been on dialysis since 1984. Can you believe it? I mean, 38 years of dialysis, and he had also two failed transplantations and was successfully transplanted at the hospital in Barcelona, and he is also doing fine now. Two very unique cases here, which of course encourage other clinics to use our product. If we move into other spaces, like the autoimmune space, then this is a very interesting field. There are more than 100 different autoimmune indications. These are indications which typically are triggered by a virus or a bacteria, and where the immune system starts to attack the body's own organ.
Some of these are acute, and others are chronic. The vast majority are chronic indications, which requires, I mean, treatments, many treatments over time. With our first-generation enzyme, we can, of course, focus on the acute indications, especially those requiring a single dose, and that's what we are doing. I can show it on this slide with anti-GBM and GBS. These two indications are two good model indications for us because they are monophasic. I mean, a single dose would be enough to actually treat these patients if it's done in time. If our technology works in this patient population, of course, there's reasons to believe that it will also work in other acute autoimmune diseases.
If we take the first one, anti-GBM, where we have actually demonstrated encouraging clinical data from a phase two program a couple of years ago, it's a ultra-rare indication, so approximately 1.6 patient in a million are identified. It's an indication which, you know, in many cases, I mean, it make patients or lead to dialysis, or patients even die after six months, so it's a very severe indication. Today's standard of care is plasmapheresis exchange and cyclophosphamide. It's not really sufficient today. What we have demonstrated now in the phase II is that, I mean, with our compound, we can see the opposite, that two-thirds of patients are being dialysis independent, and they are, in general, doing good, which is rather unique.
Those data were published in a peer-reviewed journal, JASN. We are now doing a phase III study in this indication. Guillain-Barré syndrome is another acute autoimmune indication. It's an aggressive acute autoimmune indication which hits the peripheral nerve system, and it's triggered by a virus. It could be a Zika virus, it could even be COVID. It hits roughly 10,000 patient in the seven major markets annually. One-third of patients would require mental or mechanical ventilation, and there's a mortality of 3% to 5%.
We have just completed enrollment in this study and expect high data level readouts in the second half of the year and data on efficacy versus registry in the Netherlands in 2024. It will be very interesting to see these data from the GBS study. My personal favorite is actually what we're doing in gene therapy because here, I mean, there's a big issue with patients suffering from neutralizing antibodies. The reason is that, in general, a lot of gene therapies will be delivered through a so-called viral vector and adeno-associated virus. That actually is an issue for a number of patients, actually, between 5 and up to 60% or even 70% of patients.
Which will not be eligible for treatment with the traditional gene therapies. We have reasons to believe from a preclinical study now with Sarepta that we can actually take down those neutralizing antibodies preventing people from being treated. This is potentially a breakthrough for Hansa because this will be applicable across a number of gene therapies. That's what we are trying to illustrate on this slide. We actually have three collaborations covering four indications, but there's, I mean, reasons to believe that we could actually collaborate with even more partners. We are currently collaborating with Sarepta on two programs, Duchenne muscular dystrophy and limb-girdle.
We have a partnership with AskBio, which is Bayer AG's gene therapy franchise. More recently, we have done a collaboration with Genethon, a French research institution. If we can show it now in real patients, there are reasons to believe that we will, of course, have more patient or more partnerships down the road for Hansa. On my last slide, before we enter into the Q&A, I just wanted to highlight how we are committed to driving our business forward in a sustainable way. Of course, we have established a framework around this. It's, we have three guiding principles. Healthy people, we want to address those patient groups with high unmet medical need, relevant with IgG-mediated diseases.
This is our contribution to the healthcare society, that there's also focus on these indications, not only the large indications, but that we actually find solutions for this patient group. We also want to drive a business in a very transparent, ethical way. I mean, that's how we want to drive business and behavior. We want to cultivate collaborations, inspiration and innovation. That's our way to drive business. Finally, we also want, of course, a healthy planet by doing our business in a sustainable way, using renewable energy. That's how we operate at Hansa. Yeah. With that, I'll leave the word back to Ludvig.
Yes. Thank you for a very nice presentation, Klaus. Maybe we should... We're a bit short on time, so maybe we should start with the GBS trial that you're reading out later this year. This is maybe the most important thing for the, from an investor point of view, happening this year. What kind of results will you present, and what would you consider a good result?
On GBS, we recently completed enrollment in this phase II program. We have two data readout when it comes to this. We have a high-level data readout in the second half, which will be focused around safety and tolerability for GBS. More interesting, we will look at efficacy versus this patient registry I mentioned during my presentation in Rotterdam, which is expected to come out in 2024. That will actually look at patients treated with IVIG, and how would that look versus the Imlifidase plus IVIG patient population in terms of efficacy? Can you halt the disease progression, which, of course, affects if, I mean, the patients don't get, you know, these long-term impacts on the nervous system.
Right. Right. Can you mention anything about what kind of magnitude of efficacy that you expect, or is that not really clear since it's a phase II trial?
Yeah, I mean, we'll have to see, once we have the data. I mean, you will have a patient population to actually compare against, right? Of course, if we can show it in statistic significant superiority, I mean, of course, that would be ideal.
Yeah, perfect. Okay. I know that you don't provide any sales guidance in Europe now for your product. Can you maybe try to explain when you expect a significant pickup in sales, and what would be the driver of such a pickup?
Yeah, I mean, we illustrated it on the slide before, that we have now established market access in 12 markets. Most importantly, the largest markets, right? I mean, we're building the foundation. Clinics are also generating the first experience. We have always said that we encourage clinics to treat 1 patient at a time. We're seeing good outcome in the first cases. Then, of course, there's protocols, there's guidelines, which are also being implemented now. Not at least, I mean, we are seeing changes to the kidney allocation system, such as Eurotransplant, which is now explicit, allowing for an Imlifidase tier. That should also be very beneficial for patient uptake. We actually expect here in the second half of the year that sales should increase.
Right. Perfect. Okay, last question for you, Klaus. You mentioned that you're in several collaborations with gene therapy companies. Could you describe how this development program differs from maybe a traditional drug when you use this combination, so to say?
Yeah, I mean, we have already demonstrated how well our mode of action works, right? I mean, we have reasons to believe that, of course, that, I mean, with an approved product, that we have a shorter way. I mean. Of course, it will depend on the conversations with the regulators eventually. In the case with Sarepta, now they are going for accelerated approval, right? I mean, we could potentially also benefit from that, right? With a small study, I mean, which could be done in a short time frame. I mean, it depends on the conversations with the regulators, of course, and the unmet medical need, not at least.
Yeah, perfect. That's everything from us. Thank you, Klaus.
Thank you so much for your interest.