Next up is Hansa Biopharma, and we will be joined by speaker Klaus Sindahl, Head of Investor Relations.
Good morning, and thank you so much for your interest in Hansa Biopharma. Can you hear me?
Yeah, absolutely. Please go ahead.
Okay. Yes. My name is Klaus Sindahl, and I'm the Head of Investor Relations here at Hansa Biopharma. I'm very excited to come here and present Hansa Biopharma to you at this Orphan Drug Event. Before I continue, I just need to briefly show you this slide on our forward-looking statements. Hansa Biopharma has now progressed into a commercial-stage biopharmaceutical company. We have a broad clinical pipeline in transplantation and in autoimmune diseases. We are more than 110 employees. We are based out of Lund. We also have operations in Europe and the U.S. We currently have a market cap of around SEK 7 billion. Since most of you are fairly familiar with Hansa Biopharma, I will not spend a lot of time on talking about who we are, but rather I will talk about our recent development.
As you can see from this slide, we have had a very eventful year over the past 12 months, with triple validation of our technology platform. First and foremost, of course, with the conditional approval in kidney transplantation. Secondly, we also had a positive data readout in anti-GBM, which is the first indication outside of transplantation. Thirdly, we also entered into a partnership into gene therapy with Sarepta Therapeutics in two indications. Very eventful year, and this year has also started quite well, as we in the first quarter have continued to see clear progress with the first commercial sales of Idefirix recorded in the first quarter. As I said before, it's essentially transforming the company into a commercial-stage company. Also, I want to highlight that we recently entered into a preclinical collaboration with argenx.
A collaboration which is set up to explore the potential of combining imlifidase or our technology with efgartigimod, argenx FcRn inhibitor. These two technologies would complement each other very well. We are testing that pre-clinically. Lastly, our commercial activities in transplantations are also underway as planned, and we expect to get the first national reimbursement here in the second or third quarter this year. A key part of that reimbursement process is to do these health technology assessments, which needs to be conducted to evaluate the health economic impact of using Idefirix. This was actually done in Sweden very recently with the TLV report, with a very favorable outcome supporting the use of Idefirix. We are, of course, very pleased with that. If we should spend just a minute on talking about our technology.
The foundation of Hansa Biopharma is built on this unique IgG antibody-cleaving enzyme, which comes from a human pathogen, a bacterium called Streptococcus pyogenes. This enzyme has a very clear mode of action, as you can see here on the slide, where it essentially from a 15-minute infusion, in two- six hours, actually inactivates the IgG level or puts it below detectable level. You create a seven-day window where you basically can enable transplantation in highly sensitized patients as we are doing now. imlifidase is a great product. It's a great technology. It's specific to IgG and all subclasses of IgG and nothing else. However, there is one issue since it comes from a human pathogen, it's immunogenic, so it can only be used for acute treatments. It cannot be used for relapses, so continuous treatment in acute diseases.
We are not developing it for chronic treatment. We are only focused on acute treatment. We have, however, a second-generation technology called NiceR, where we potentially can enable that space, and that's also acute space. As depicted here on this slide, we are currently focused on three spaces. Transplantation and post-transplantation, this is here where we got the first approval in kidney in Europe. We also are looking into potential dealing with rejection episodes after transplantation, which is occurring in roughly 10% of all transplantations. Below you can see that we are also in two autoimmune diseases in anti-GBM and Guillain-Barré syndrome. Two indications outside transplantation I'll get back to in a moment. We have entered this partnership with Sarepta, as I told you, initially in limb-girdle and Duchenne muscular dystrophy. That's still pre-clinical, however.
This slide depicts our business model or our value creation model, if you like. If you look to the left, we have our growth engine. This is our enzyme platform. As we develop new enzymes or develop new drugs from enzymes throughout the value chain, we would like to control or we control key elements in the value chain. As we approach commercialization, we have two different paths. One is to go through our own commercial infrastructure. We will do that in transplantation and autoimmune diseases because it makes sense. It's a very targeted audience, and we have the in-house capabilities to do so. Whereas in gene therapy and in oncology, we would actually approach the market through a partner just like we have done now with Sarepta. Two different approaches on the strategy.
As I said initially, we are now a commercial-stage biopharmaceutical company. We have recognized the first sales, our launch activities are underway as planned. The first pricing, the initial pharmacy pricing levels have now been published in seven markets, including the Nordics, Benelux, Germany, and U.K. We have seen clear progress. As well as supply chains are now being established for the initial distribution to these leading transplantation centers. Secondly, we are also in close dialogue with the reimbursement authorities, national reimbursement authorities in a number of countries. As a key part of that, we need to do these, or they will do these health technology assessments, and we had the first one in Sweden favoring imlifidase and actually even suggesting it as a cost-saving treatment towards the standard of care today, which is dialysis. We are of course, very pleased with that outcome.
In parallel to the reimbursement process, we are also trying to see if we can access patients outside for key centers, local access programs, and that's what we will continue on in parallel. Launching imlifidase or Idefirix, we are not doing it by a traditional launch strategy where you are blasting out the product in a number of countries at the same time, and you are focusing on the larger markets initially. We are rather focusing here on leading transplantation centers. We have a center-by-center focus, and we are initially focusing on countries where they have access to patients, early decisions, reimbursement, and where they have adaptive legislative systems and allocation systems. Where the access to the markets is the easiest.
Initially, we'll be targeting very few centers, but leading centers to sort of create these centers as centers of reference for the further rollout. The second wave of our rollout will be the more complex markets in Europe, where there's not necessarily access today. It requires some more leeway to get into the markets. We need to work around that, medical protocols, et cetera. We need to navigate allocation systems and legislation. Thirdly, we are also targeting a third wave in rest of the world, so markets outside of Europe and U.S. We actually plan to have a partnering strategy, in markets where we can sort of build off the EMA approval, and it could be countries like Israel or Australia.
Then, the fourth wave is, of course, the U.S. where we are about to commence a new US trial, which is of course, subject still to approval on the protocol. If everything goes as planned, we should be able to file a BLA by first half of 2024. This is just a snapshot of our pipeline activities, I will just highlight the three clinical programs. anti-GBM, AMR, and GBS. anti-GBM is actually where we had this positive data readout last fall, where we got essentially a proof of concept that the patients who got imlifidase treatment, actually 10 of these patients reached dialysis independence, which is a very good outcome because usually you would see two-thirds of all patients progress into dialysis or even die. Now we are preparing for regulatory discussions with EMA and FDA on the path forward.
AMR, acute episodes, rejection episodes after transplantations are very important projects. As I said, 10% lose their kidney after transplantation. We are now enrolling patients to this study, and we currently have nine patients enrolled and expect to complete enrollment by the end of this year. Guillain-Barré, a very severe autoimmune disease where many patients will end up in respiratory support. It's an acute episode you need to deal with, and we believe we have a good fit with imlifidase there. Eight patients have enrolled into the study out of 30 patients, and we expect to complete enrollment towards the end of this year. With this slide, I just wanted to depict other opportunities in the autoimmune space because it's actually very exciting. As you see, anti-GBM and GBS are just a few opportunities.
This is actually a very interesting space because there's not a lot of approved treatment, especially not on the acute side of things. Of course, we believe this area holds significant potential. We are very pleased with the first data readout in anti-GBM. Lastly, I also want to touch upon gene therapy. In gene therapy, the issue is that a lot of patients are not liable for treatment given that they have neutralizing antibodies, which prevents effective treatment with the gene therapy. The idea here is that with imlifidase, we can inactivate the neutralizing antibodies and enable the gene therapy to work in these patients.
A really huge opportunity and where we initially have done a partnership now with Sarepta Therapeutics. It's still preclinical phase, but we have seen very encouraging data, which was published in "Nature Medicine" not too long time ago, with very encouraging outcome in a mouse model and in monkeys, where we actually saw transduction was enabled. Similar to the autoimmune space, we see very huge potential in gene therapy, as basically all gene therapies deal with these issues around neutralizing antibodies. Now we are in two indications, but the partnership with Sarepta is only exclusive when it comes to these two indications. There are actually significant potential beyond that. That's what we'll continue to pursue. We are in a number of dialogues with different parties at different stages. Very exciting fields. With this, I will conclude my presentation.
As you see, we have a very exciting year going forward, or a lot of milestones. We expect to move on with our second-generation enzyme, NiceR, initiate our IND-enabling tox studies. We expect to get the first national reimbursement agreement in place in the second or third quarter. We expect, assuming the protocol will be approved for the US study, we expect to dose the first patient in the second half of the year, and then complete enrollment in our AMR and GBS study towards the end of this year. With that, I will leave it back to the moderator.
Thank you, Klaus. A very exciting and efficient presentation. My name is Johan Unnerus. I will be guiding you for the Q&A. We can start off naturally with the sales, as you do actually have sales now. I understand the initial part comes from Germany. Could you elaborate a bit on that?
I can confirm it's from Germany, and we are very pleased that we now have moved into a commercial state that we have actually recognized or recorded the first sales here in the first quarter. Given that these are high-risk patients, et cetera, we are not envisioning to be very much granular on the patients and the clinics, et cetera. Beyond confirming that the first sale is from Germany, I'll not go into more detail on the patients.
This process of establishing reimbursement and the technical economic studies that are progressing, is it possible to indicate anything on the pricing level and the clinical proposition
The pricing of imlifidase now it's out there in the market, in seven markets. The pricing is around or just shy of EUR 300,000. That price is based on the value the drug provides to the patient, the society, the healthcare systems. We are actually very comfortable with that price level that we have put out. Of course, it's not a reimbursed price, but we expect it to be around that level.
Interesting. When it comes to take-up and the specialist center that presumably is in the first wave, can you elaborate something about this? Of course, it's very early stage. On the dynamics, are many of them going to wait and see for clinical outcome and evidence before taking up?
It's clearly our intention to focus on leading transplantation centers who have experience already in desensitization, who are likely to become early adopters and centers of reference for others. These leading centers are what we are focusing on initially, and it's important for us that we generate positive outcome in these patients. Expect them to take patients in one by one, and then you should see the learning curve go in our favor. It's not our intention to go out more broadly initially. Remember, the studies or the protocols approved on four phase II studies are very unique. It's a conditional approval. It's a paradigm shift. It's a new transformative technology. We need to be very careful here in the initial phase of the rollout.
As positive experiences are generated and we see good outcomes, we should see it roll out faster in year three and onwards.
Are we likely to get clinical sort of feedback and experience already, let's say, early next year or late this year?
Since this is based on phase II data approval, it's a conditional approval, as I said. We are doing a post-approval study in parallel, which would generate more of the same data, which will support. Remember, this imlifidase is only approved in very few patients. It's 53 patients who have been treated. More data will come that we're doing this study in parallel.
Yes. Time is flying. I want to touch on the strategic position and the perception of Hansa Biopharma. Just to give some examples, I think your presentation was very good. Gene therapy is one area which is massive and your mechanism actions seems promising in neutralizing NAbs and perhaps if you can bring NiceR to the market, you can have more of a sustained recurring effect as well. To move on to my question or reflection, Hansa Biopharma, in many investors might see as it's done now. It's been a long journey. It's been a fantastic journey. You're out in the market. What's next? You seem to have a sea of opportunities and you get the sense that perhaps many investors are not really recognizing this. Can you tenfold the next capital injection as you've done previously, and how long will that take?
No, well, our own guidance on finance situation is that we are fully financed now. We have SEK 1.3 billion on the books. We are financed into 2023. I'll not comment on that. Given the platform, I fully agree this is a very versatile, flexible platform with huge opportunities in many, many spaces. It's transplantation, it's autoimmune diseases, it's gene therapy, and even potentially oncology, right? We see lots of opportunities both with our first generation but also with the potential second generation. We are also doing in between work now with the argenx fight. We look at a bright future for Hansa Biopharma.
You shouldn't underestimate, of course, the challenges and the risk, you're now in a position where your candidate and mechanism action, if anything, is possibly too powerful.
Let's see. We're in a good spot, and we are looking forward to advance our programs and more data readout and potentially also entering new fields.
Okay. Thank you very much again. Time is running out, so let's move on to the next presenter.
Thank you.
Thank you.