[Non-English content], Claus.
[Non-English content ]. I hope it's okay I'll do the presentation in English, even though you can ask questions to me afterwards in Swedish. I'm happy to answer those. Thank you so much for inviting me to this Penser Bolagsdag. I'm very much looking forward to present Hansa for you. Before I start, I just need to show you this forward-looking statement. You of course need to discount whatever I say. Hansa Biopharma for those who are new to the case or just want to understand where we are today. It's a fully commercial-stage biopharmaceutical company based out of Lund. We are roughly 130 employees today. Actually, it's a good organization now. I mean, commercial-stage etc. We are now building our team across R&D and commercial.
It's a very experienced team. I mean, we have on average 20 years of experience in the life science sector. A good qualified team. We have a technology which has now been validated in three different indication areas. First and foremost, of course, with the regulatory approval obtained 18 months ago in highly sensitized kidney transplant patients. Then secondly, in the first autoimmune indication. The first indication outside of transplantation, which is a disease called anti-GBM. It's an ultra-rare disease, but very interesting, and I'll get back to it. Actually we released a press release yesterday on Journal of the American Society of Nephrology, which actually validated or wrote about the data we have come out with.
Thirdly, we have also validation in gene therapy. It's a fairly new space to us, but we have nevertheless already two partnerships here with Sarepta Therapeutics and AskBio, which, the latter one, was announced here in the beginning of January. Here the idea is that imlifidase, our lead compound, will help the gene therapy companies inactivating the neutralizing antibodies, which prevents a large proportion of the patients to be treated with the gene therapies. Very exciting area where we are doing preclinical studies right now. We have a broad pipeline in transplantation and in autoimmune diseases and also a preclinical pipeline with these programs in gene therapy.
From a market capitalization point of view, our current market cap is around SEK 3 billion, and we are financed into 2023 with the current cash in hand and with the projected expenses. We're listed here in Stockholm, and we have roughly 18,000 shareholders. As I started with, we have many milestones which have been achieved over the last 15-18 months. First and foremost, as I said, initially, with the regulatory approval, and now we are actually seeing good progress in what is actually the, you know, the enabler to get to these transplantation clinics, because we have actually now secured pricing and reimbursement in the first five countries, and we have ongoing process in 14 countries. Beyond Sweden, which was the first country, we also have the Netherlands.
We have Greece, Finland on a hospital basis. Then we also last Friday, we obtained early access in France. France is actually the largest market within transplantation. Very, very interesting. Beyond that, we have actually had three partnerships established over the last year. First with argenx in combination therapies, where the idea here is to combine efgartigimod, an FcRn inhibitor for maintenance therapy with our imlifidase for acute treatment to enable more therapeutic areas. Very, very interesting. We have also done a collaboration in kidney transplantation with Medison Pharma covering a number of Eastern European countries and Israel. As I said initially, AskBio, new collaboration in gene therapy.
If I should go a step back and talk about our lead compound imlifidase, it stems from a bacteria, a human pathogen, Streptococcus pyogenes. What it does is it very fast and effectively cleaves IgG, which is 80% of the human immune system. It does that in two steps. From a 15-minute infusion, you would see two to six hours afterwards that your IgG level is below detectable levels. Very, very effective enzyme. As you see here on the right-hand side of the graph, the IgG level goes down very fast, and then it will stay down for up to seven days.
This is the window where it's relevant for enabling kidney transplantation or, if you want to knock down IgG in context of an autoimmune disease where the immune system starts to attack, the body's own organs. Then it gradually will start to come back again. This compound has immense applicability across a number of different indication areas. We have depicted four areas on this slide here to the left-hand side. Transplantation pre and post. As I said, first indication now approved in kidney, but there are also other relevant areas such as lung and heart, and also after transplantation to avoid these rejection episodes. Left-hand corner, we have acute autoimmune diseases.
We have two programs here, GBS and anti-GBM, where the body or the immune system for various reasons start to attack the organs, as I said before. Very encouraging data from anti-GBM. Three programs, preclinical programs in gene therapy with AskBio and Sarepta we're looking into, Duchenne muscular dystrophy, limb-girdle muscular dystrophy, and more recently, Pompe disease. Fourthly, we have also started to explore oncology within hematopoietic stem cell transplantation, which is actually a quite interesting area on the size of kidney transplantation. To the right-hand side, we have our next generation of enzymes which can be used in more chronic indications where you can deal with flares, recurring flares. Just a few words on our business model.
To the left-hand side you see here the our growth platform. Here we are developing new enzymes, and as we develop the enzymes and take them through the value chain, it's our intention to go to the market with our own commercial infrastructure in transplantation and autoimmune diseases because the landscape for clinics is rather focused, and we can actually address that with our own commercial organization. When it comes to gene therapy and oncology, we want to address it through partnerships like we have done now with AskBio and Sarepta. A very clear model and also where we illustrate that we can actually take up the majority of the value within transplantation and autoimmune indications.
Our first approved drug, Idefirix, as it's called commercially, is targeted or is labeled for highly sensitized patients who are incompatible to a deceased donor. Highly sensitized patients in general are patients with too high levels of antibodies, can be due to pregnancies, can be due to blood transfusions or previous transplantations. This group of patients have very limited access to new organs in the systems because of these high level of antibodies. This is what we now can address with Idefirix/imlifidase. It's actually even though it's 10%-15% of the wait list, it's actually a fairly large patient population if you look at it overall. Across U.S. and Europe, we have roughly 170,000 patients on the wait list.
As I said, 10%-15% is equivalent to 25,000 patients in total. Of course, not all of them will be treated with Idefirix, but I mean, they have to wait very many years to wait for an organ. 50,000 transplantations are being carried out across the U.S. and Europe, as you see here, two markets which are roughly similar in size. We have initially only labeled for deceased donor transplantation. If you look at it in theory, it would mean that around 5,000-6,000 patients would be relevant for Idefirix with the current indication or label. Just a few words on the commercial launch process, because we're actually starting out building the foundation with the leading transplantation center.
It is very important that the first clinics generate positive experience. Imlifidase was only tested in five clinics in 46 patients. We are building a plane, flying it right, because we need to expand the usage through good experience, focusing on the leading centers who have experience within desensitization. We also need to establish medical guidelines, protocols, etc. It's very important that we do this in a careful manner. We need to do a post-approval study because it's a conditional approval only based on phase II data. It will take a couple of years before we will start to see more exponential growth. Once we have obtained full approval in Europe and also in the U.S., which is set to be in 2024, as it looks right now, we should see much more exponential growth.
On top of that, we're also working on partnerships in rest of the world, like the Medison agreement we did end of last year. People or investors need to have a bit of patience, look at, you know, the foundation we are building for repeat business to occur. Then after a couple of years when we have obtained pricing and reimbursement, we have established a good foundation for the business. We should, as I said, see more exponential growth. Then in 1/3 wave, we look at potential label expansion into living donor transplantation, into other solid organs such as heart and lung, and also these post-transplantation episodes. Here we will enable new growth pockets. This is how we envision the growth journey just in this area.
We have other areas of course, just for people to understand, we're building the groundwork for imlifidase. This slide illustrates where we are currently with our market access processes. As you can see, we are quite active now. We have processes going on in 14 countries. If you focus on the countries with the dark blue, it's where we have obtained now pricing and reimbursement. I mean, this is a great validation with the early access in France. I mean, this compound costs just shy of EUR 300,000 or SEK 3 million for one treatment, right. It actually resonates very well with the value proposition because the alternative today is dialysis, which costs SEK 750,000 a year for these patients.
They, I mean, they are getting treated every second day, three, four hours, where they are getting these antibodies washed out of the blood. I mean, they can't work, et cetera. You can, you know, make sure that these patients get back to a real life and even work. Pricing reimbursement obtained now in Sweden, Netherlands, and Greece, Finland on a hospital basis. Then, as I said, early access in France, which is the largest markets actually. We expect additional of the E.U. top five markets to be processed very soon. These markets make up 15,000 transplants a year, so it's not insignificant. This is my last slide.
I just wanted to highlight that even though we've talked a lot about the kidney transplantation opportunity because it's near term, it's where we have our current commercialization focus. We actually have a unique platform, not only from a technology point of view with imlifidase, but also from a more commercial point of view as we actually can expand into so many different indication areas where this technology is relevant. I mean, IgG-mediated diseases makes up a lot of the indications in autoimmune disease, transplantation, gene therapy, and oncology, right? We actually have programs in each of these franchises, as we call it. Given the good data which was announced yesterday or published in the peer-reviewed journal from American Society of Nephrology.
I mean, we're really building the foundation for a great company here. Also, beyond imlifidase, we're looking at next generation of enzymes. We are looking at combination with argenx , et cetera. We are only scratching the surface with this technology. With this, I will hand back the word to the moderator and Ludwig.
Thank you, Klaus, for a good presentation. In the presentation, you showed us this commercialization process in Europe divided into three phases.
Yeah.
Can you give us a high-level guidance on when we can expect you to enter the next phase, so to say?
Yeah. I mean, as I also said during the presentation, it will probably take us a few years to land these pricing reimbursements, which is, I mean, very critical to get access into the markets, right? Then on top, we need to increase awareness around imlifidase. I mean, work with patient organizations to continue to focus on this unmet medical need. We need to establish medical guidelines. That's also in the works, right? We need to do a lot of different things to build this foundation, right? It will probably take a couple of years before we have seen, you know, repeat business at the center level and where we start to see more exponential growth. Then in the next wave, we will also get the U.S. approval.
We'll probably build on the EMA approval to expand into new geographies. Could be Australia, Canada, Brazil and whatnot through partnerships, right? I mean, it's really around doing the work in the right manner with the right pace. I mean, we only have one shot at goal, right? We need to do it in a diligent manner.
Right. As you said, you got this reimbursement feedback, the positive one from France under the Early Access program.
Yeah. Yeah.
Which is initially valid for one year.
Mm-hmm.
Can we expect this to be like, further than one year after this? Or what happens after this first year, so to say?
It's a really good question. The early access is actually great that we have already achieved that. The full reimbursement process is normally between 12-18 months in France. Of course, that's where we eventually want to go. That's still ongoing.
Mm-hmm.
Hopefully, I mean, at the time when the early access expires, we are ready to go into the full reimbursement, right? I mean, it could, in theory, also be extended for a few months if that's needed. But of course, it's important that we see good experience with the clinics. They see patients being transplanted and good outcome afterwards. Through this monitoring phase, and then, I mean, then this should be a good opportunity to achieve full pricing and reimbursement. Yes.
Yeah. You expect that like right after maybe this reimbursement?
Yeah. I mean.
Yeah.
It could take a few months afterwards, but yes.
Yeah. Perfect. As you mentioned, this is only based on a phase II study.
Yeah.
This approval, and you need to conduct a phase III study. When can we expect this to start? Can you provide some kind of guideline on how many patients and-
Yeah. Absolutely. First of all, I would like to emphasize. It's very unique to get approval, conditional approval based on phase II. I mean, we had 46 patients, but all were transplanted, and normally these patients would not be able to go through a transplantation because of their high level of antibodies. We showed that with 100% efficacy, and with a great safety profile. Now we are going to conduct a post-approval study. You need to do that. That's going to be done in 50 patients across roughly 20-25 centers. We will carry that out in some of the existing markets, as you saw, but also in new markets to broaden out the experience with the drug.
It's very natural and this is, of course, also one of the reasons for this S-shaped launch curve as we talked about, because you need to handle that in parallel with the commercial launch process.
Right. Right. Perfect. If we move out from the kidney transplant area, and we look at other solid organ transplants.
Yeah.
What is the plan here? Are you planning on initiating phase II studies here soon, or are you awaiting more data from, or more feedback on the kidney transplant area before doing so?
Yeah. I think for the time being, we want to stay focused. I mean, as you mentioned, heart and lung, I mean, those are really interesting opportunities longer term.
Mm-hmm.
Right now, I mean, it's about handling the commercial loans and what we have in the pipeline.
Mm-hmm.
Stay focused so we do that successfully. It's clear that we want to expand both geographically into new areas, but also as we talked about in with the label into living donor transplantation, I mean kids, et cetera. I mean, so that's natural right, follow-ups and then AMR for rejection episodes, I mean, before we really get into heart and lung. Yeah, it's definitely interesting opportunities.
Yeah. You decided that you will add some centers to this phase or these phase II studies in GBS and AMR.
Yeah.
How is the patient recruitment going there? How are you seeing some positive effects on these added centers?
Yeah, absolutely. It was a decision we took last fall, given the pandemic and how things looked, that we wanted to add more centers to accelerate the enrollment. Actually, if you look at AMR, we are at 26 patients currently out of 30, so we are very close to completing the enrollment in that study. GBS, however, has been impacted a bit by COVID, not least because a number of our centers are based in France. Also on top of that, we've seen lack of IVIG, which is part of the protocol. We've seen a slight setback here, but we will update our guidance to the GBS here in April when we announce our Q1 results.
I mean, it should pick up again, and we should see good traction, but we are very excited about that we can close AMR very, very soon.
Great. I had some more questions, but I think we can prioritize this.
Absolutely.
because we got some from the web. Will the anti-GBM phase III study commence this year? If so, which quarter do you believe we will see the first enrollment?
Yeah. Absolutely. I mean, that's our guidance to initiate the anti-GBM study in roughly 50 patients in at least 25 centers. It could also be 30 or even more centers. It's an ultra-rare disease. It's only 1.5 patients out of a million, so you need many centers to recruit patients here. We have guided that we will initiate the study across U.S. and Europe this year. We have, I mean, now we have the go-ahead with both the EMA and FDA. We don't guide per quarter. I mean, it doesn't make much sense. I mean, but just that we establish the phase III studies is great now, but also because it's the first indication outside of transplantation, obviously.
Yeah. Great. Someone is asking about the, some other international markets such as U.S., China and Japan. U.S. you all already addressed, but China and Japan, do you see any?
Yeah. Those markets are actually quite different. I mean, it's normal that you do studies in U.S. and in Europe, and then other markets are building on that data. That's pretty much the standard when it comes to new compounds. Those markets are very interesting. In Japan, there is a difference compared to the European market in that it's mainly living donor transplantations. We currently don't have label for that. We only have for deceased, which is roughly 70% of all transplantations today, right? It's probably a bit further out. China is a good opportunity, but here it's also about finding a trusted, credible partner in China, I mean, to potentially pursue that strategy. But it's definitely something we are looking into.
Also, as I said, Australia, Canada could be other markets.
Yeah. Perfect. Great. Now we're running out of time. Thank you very much, Klaus. Nice to have you here.
Thank you so much for your interest.