Our next company to present is Hansa Biopharma, who is focusing on transplants and autoimmune disorders. With that short introduction, I would like to hand over to the CEO, who is going to present the company. Go ahead, Søren.
Thank you very much for that introduction, and thank you everyone for your interest in Hansa Biopharma. Please move to slide number two. I just want to point to the fact that this presentation contains forward-looking statements, and as such, you should apply the usual caution. Please go to slide number three. I presume that Hansa Biopharma is a pretty well-known entity to most of you, but still, if there should be just a couple of you in the audience for whom this is a new case, let me provide a very high-level brief overview of the company to give you some background. Hansa Biopharma was founded back in 2007 as a spin-out from Lund University in southern Sweden. The genesis of the company really was the identification of an enzyme today known as imlifidase, which has the unique property that it very fast and effectively cleaves IgG.
It was thought that that could have therapeutic application across a number of different indication universes. If you then fast-forward 13 years, today we are a late clinical stage biotech company, still headquartered in Lund. We have approximately 80 employees. The majority are employed in R&D, but we are also building a commercial infrastructure. Most of our employees are still based in Sweden, but we have a growing number of employees also across Europe and in the U.S. We have a number of global functions that are headquartered out of the U.S., medical affairs and global market access, for instance. We are listed on Nasdaq in Stockholm. We have a market cap of approximately SEK 5 billion.
We have a significant and rich and growing pipeline of drug candidates within transplantation and autoimmune diseases, and we have potential beyond these indication universes, and I will touch on that later on in the presentation. We last raised capital back in 2018, and we are currently financed well into 2021. Please move to slide number four. This is going to be the only slide on the mechanism of action, I promise. Very briefly, imlifidase is produced by a human pathogen called Streptococcus pyogenes as part of this pathogen's defense against the human immune system. Imlifidase works through an enzymatic process whereby it essentially decapitates, if you will, the IgG molecule just below the so-called hinge section, creating a F(ab')2 and an Fc component, thereby rendering the molecule inactive almost immediately. It is specific to IgG, all subtypes of IgG.
The way it works is, as I said, extremely fast. If you go to and have a look at the right-hand side of the slide here, you see that essentially, IgG levels drop to below detectable levels within two hours of a 15-minute infusion. IgG levels stay below detectable for around seven days before gradually bouncing back, and then within a month or so, the IgG levels are back to normal. Please move to slide number five. As I said, initially this company is approximately 13 years old. We hope to have the first regulatory approval this year, imlifidase for enabling transplantation in so-called highly sensitized patients in Europe. If that happens, then it would have taken us 13 years to get to that stage, and that's in line with the average for drug development candidates.
Of course, in our case, we had to build a whole company around it. From that perspective, it's a pretty remarkable achievement. It's only been possible because there has been a laser-sharp focus on this early indication early on. Within the past couple of years, we've also started to branch out, and we have dived into other indication universes, not just within transplantation, but also in autoimmune diseases. As I spoke to early on, we see potential outside of these two indication universes as well. Please move to slide number six in our equity story. The reason why I joined the company a couple of years back really was because I see tremendous potential, not just in transplantation, but really in a number of broad, very valuable indication universes. Right now, we're active in the transplantation and autoimmune disease spaces.
In transplantation, both as far as enabling transplantation is concerned as well as treating post-transplant conditions, so acute antibody-mediated rejection episodes. We've also dived into the autoimmune disease space. Obviously, that's a very large indication universe where more than 100 autoimmune diseases are currently identified. Many of these have no approved therapeutic options available, and they're very serious conditions. This is also an important indication universe for us, and we're already active in that space. For both transplantation and autoimmune diseases, because the target audiences are fairly concentrated and because of the high degree of unmet medical need and the lack of competition in certain areas, it's our strategy to go all the way to the market ourselves and launch drug candidates coming out of our pipeline ourselves.
Beyond autoimmune diseases and transplantation, we are also looking at gene therapy and oncology already in the gene space, and I'll talk a little bit about that later. As you know, there are clearly some challenges with neutralizing antibodies, both preexisting and developing antibodies that essentially makes quite a number of patients, depending on the vector, ineligible to benefit from modern gene therapy. That's a space that we're looking at currently. We're also looking at the oncology area, both anti-drug antibodies, and we are hopeful that our enzymes could potentially enhance the efficacy of immune oncology therapies in that space. For both gene therapy and oncology, clearly, given the fact that we need complementary assets there, and these are very complex and costly spaces to operate in, this is partnering territory for us, and we're already in discussions with a number of leading players both within gene therapy and oncology.
Please move to slide number seven. This is a little bit more granular outline of the stepping stones and the potential path forward for both our first-generation enzyme, imlifidase, and subsequent generations of enzymes that we're already now developing. imlifidase is unique and has a very good profile in that it works very effectively. It's safe and well-tolerated. The one drawback it has is that since it comes from a human pathogen, it is immunogenic, and therefore, we're not developing it for repeat dosing scenarios. What we're doing right now is we're looking at transplant settings where a one-off therapy is enough to qualify patients for a transplant or to deal with a post-transplant episode. We are currently focusing on the kidney, but beyond the kidney, obviously, there are other organs that could be relevant, like lung and heart, and bone marrow, potentially.
In the autoimmune disease space, we're also looking at acute autoimmune diseases where you have one attack, monophasic autoimmune diseases, and if you deal successfully with that attack, then you're okay as a patient. There we have ongoing trials with the ultra-rare disease anti-GBM or Goodpasture's disease, as well as the Guillain-Barré syndrome. Beyond that, there's a number of similar diseases, very similar diseases in terms of the seriousness and the way that they are triggered by IgG-based antibodies or antibodies. There are diseases like NMO, for instance, or ANCA-associated vasculitis or lupus nephritis that could be relevant. We know that these diseases are generally IgG- mediated, and IgG plays a pretty significant role here.
If you look towards the right-hand side of the slides, we are developing the next generation of enzymes for repeat dosing, and that opens up a whole new universe of indications like chronic autoimmune diseases, redosing within the transplant setting or gene therapy setting, as well as oncology. Please move to slide number eight. Let me spend a minute or two on our lead indication and the data supporting this drug candidate so far. The lead indication is enabling kidney transplantation in highly sensitized patients, that is, patients that because of a previous transplant, a blood transfusion, or multiple practices, have developed antibodies that will make it very, very difficult to find an organ that is a good enough match to enable a transplant. We have studied imlifidase for this indication across four phase II trials with a total of 53 patients.
Enabling a transplant was not an endpoint in all of these, so only 46 patients out of 53 transplanted, but that represents a 100% success rate in the trials where enabling a transplant in a highly sensitized patient was a primary endpoint. So 100% success rate there. Overall safe and well-tolerated. An important secondary endpoint was graft function six months post-transplant, and there we hit a graft survival rate of 94%, which is in line with what we see in the broader universe of kidney transplant patients. So very strong and supported data coming out of phase II. Recently we have submitted a marketing authorization application in Europe. Please move to slide number nine. We submitted that application back in the first quarter of last year.
Most recently, we have submitted our responses essentially today to the list of outstanding questions and issues adopted at the CHMP meeting in April. We hope that this will suffice and that therefore there will be an opinion made possible coming out of the June CHMP meeting. In the U.S., we have aligned with the FDA around the next step there. We have agreed that we will run a randomized controlled trial, very limited in scope, approximately 50 patients, highly sensitized patients with a CPRA of 99.9%, meaning that 99.9% of available organs would not normally be a good fit for these patients. This trial will run over the next couple of years and hopefully could allow submission of a label by 2023. Please move to slide number 10. As I said initially, it is our clear strategy and intent to launch imlifidase for this indication ourselves in Europe.
We already have a core commercial infrastructure, medical affairs, and market access infrastructure in place, and we are building that as we speak. We will have a very center-focused launch strategy, it is not going to be the traditional country-by-country type launch scenarios, but rather we will go center by center, and we will focus on those centers that have not only the highest volume of kidney transplants, but that are also the most likely to become early adopters and be able to secure positive early experiences. An important part of our launch strategy will also be the post-approval study that we will agree to run as part of the conditional approval that hopefully we will be getting by the EMA. Through that study, centers, in addition to those who will be using our product commercially, will gain valuable experience with imlifidase. Please move to slide number 11.
If you look at the market potential in Europe, it is roughly similar to the U.S. in terms of volume. Approximately 100,000 patients are currently on the wait list in Europe. If you just look at the top five plus Sweden and Norway, there are 16,000 kidney transplants taking place every year. It is a pretty heterogeneous market in terms of what proportion of the population is on dialysis, and again, what proportion of these dialysis patients are on the wait list, and then what proportion of those on the wait list are being transplanted. You can see the key figures in this slide. Overall, we estimate that the addressable relevant patient population for this indication early on is 3,000 to 4,000 in Europe. Please move to slide number 12, an overview of our pipeline.
I have talked to already the kidney transplant indication and the current status in Europe and our efforts in the U.S. Within autoimmune diseases, we have two ongoing trials, one for the ultra-rare disease anti-GBM, which affects maybe 1.6 out of a million. There is no approved therapy. Currently, it is a very serious disease. Two out of three patients suffering from an attack here lose the kidney function. We have recently fully enrolled and investigator-initiated this phase II trial, 15 patients, and we expect to have last patient, last visit over summer, and we should be able to get high-level readout from this study in the third quarter of this year, which we look very much forward to. A second ongoing phase II trial is for Guillain-Barré syndrome. This is less rare, but still a rare disease affecting one in 100,000 people.
Very serious with a mortality rate of 4%-5%, despite IVIG being used currently for that indication. Up to 40% of patients end up in respiratory support and have a long period before they regain function. Here we have started this trial back last year, and we aim to enroll 30 patients. Despite the COVID-19 crisis, we do expect to have it fully enrolled, but there will be some delay, and we should have it fully enrolled towards the end of next year. In addition to these 2 phase II autoimmune disease trials, we have an ongoing phase II trial, a second ongoing phase II trial in the transplant setting, namely for post-transplant antibody-mediated rejection episodes or AMR. Again, here it's our target to enroll 30 patients, and we aim to have this study fully enrolled also next year ahead of the GBS study.
If we look at our next generation of enzymes under the NiceR heading, we have a lead candidate currently being moved forward towards immunotoxicity studies. Hope to have that enter the clinic at some point next year. Finally, we're doing preclinical work with our oncology programs. Please move to slide number 13. As I said, the NiceR program really aims at developing the next generation of enzyme overdosing settings. If we look at the autoimmune disease space, that opens up the whole universe of chronic autoimmune diseases, which is quite large, of course. There is a number of approved therapies there and also therapies on development for maintenance. Clearly, our enzymes are not being developed for maintenance because you don't want IgG suppressed completely for a prolonged period.
In many of these autoimmune disease settings, there are flares, and these flares can be quite debilitating, and obviously what you want ideally is to have immediate effect. Here, our next generation enzymes potentially could be a very good therapy to deal with these relapses, essentially. Please move to slide number 14. As I said initially, we are also currently looking at the gene therapy space. It's very promising. It's a very promising area overall with just shy of, I think, 200 in vivo programs currently. Depending on what vector is being used, though, it's increasingly apparent that neutralizing antibodies is a significant challenge, especially if you use an AAV vector, where up to 60% of patients are not eligible for gene therapy. We think that imlifidase and other enzymes could potentially be a good way of dealing with this through conditioning therapy.
We're currently in discussions with a range of players in this space, hopefully we'll be able to move this forward in a collaborative manner. Please move to slide number 15. Briefly, as far as our financing situation is concerned, as I said initially, we raised capital back in 2018, we're currently financed well into 2021, essentially into mid-2021. Please move to slide number 16. I think this is my last slide, just to briefly point out the coming inflection points in the near term. Clearly, an important one will be a potential opinion from CHMP around the imlifidase for enabling kidney transplantation in highly sensitized patients. Okay, I've just got another voice coming in here, but I'll just continue here. We also look forward to an adoption and final approval by the commission later this year and launch, as I said, by Q4 of 2020.
Our anti-GBM study should read out in the third quarter. Then we have two studies enrolling in 2021 fully, namely the AMR and the GBS studies. We also, as I said, hope to include our NiceR candidate into the clinic in 2021. I think I'll stop here in the interest of time and hand over to you for potential questions.
Yes, thank you very much for that presentation, Søren. My first question relates to your EMA process that's ongoing at the moment. Now that you're handing in your questions to the EMA, what risk do you see left in the EMA process before your expected CHMP opinion at the end of June?
We have provided a very comprehensive response to the list of outstanding questions adopted by the CHMP in April. We're comfortable with our responses here. We think that it's certainly foundation for a potential opinion in this quarter. However, in the end, the CHMP will have to weigh risks and benefits. Clearly, this is a situation where you have data from phase II trials only with a total of, as I said, 53 patients in phase II. You have a multitude of different influencers and decision-makers. In the end, you're always subject to the opinions and subjective opinions of those with influence and decision-making ability.
Thank you. Could you also perhaps elaborate a bit more on your commercialization strategy, given that you would get approval in Europe? Maybe in terms of the number of sales rep that you would need to cover this market, or what countries that are low-hanging fruits when it comes to commercialization, and maybe also how the process to get reimbursement would look like in the major markets, also in this environment with COVID-19. Thank you.
As I said, we're going for a center-focused launch strategy. We have already developed a clear list of prioritized centers that we're going after initially. It's a very concentrated target audience, as I said. Overall, if you look at it in the top five new countries, you would have 70%-80% of all kidney transplants taking place in less than five clinics, essentially. Across Europe, it's a relatively limited number of clinics that we're going after. In terms of number of sales reps and MSLs, we're looking at a low double-digit number over the coming years. As far as reimbursement pricing is concerned, clearly, as ever, you have early launch countries where you get these types of reimbursement decisions sooner than in other countries. There's an underlying matrix of early launch countries versus later launch countries.
As I said, we're not looking at this as a country-by-country launch. Already now, just discussing the process, we have, of course, been in dialogue with pricing and reimbursement authorities. We've developed a value proposition, and we've discussed it with the authorities. We're comfortable that we have a very good story to illustrate the value that imlifidase potentially could bring to these patients and the healthcare systems overall. COVID-19, you ask how we've been impacted by that. Clearly, as other companies engaging with our target audiences, key opinion leaders, clinics, influencers, patient associations, and so on, has been impacted. We have been able to create, I think, a framework that's pretty good momentum. We've been able to use virtual and online tools quite effectively and efficiently, but it's not the same. That's clear as meeting face to face.
Depending on how things pan out now, whether there's going to be a second wave or not, there has been some slowing in our, again, communication efforts and effect in the marketplace. We're pretty good at developing, as I said, tools to use in this situation. If there is a second wave, we're ready to engage head-on and full very soon.
Thank you very much. With that question, I think we're out of time here. Thank you for coming here to ABG and presenting.
Thank you. Take care. Bye-bye