Hansa Biopharma AB (publ) (HNSA) Earnings Call Transcript & Summary

Good afternoon, everyone, and thank you for coming to the 2020 Virtual UBS Global Health Care Conference. My name is [ Tay ], and I'm happy to be your host for this session. Our next presenter will be Søren Tulstrup, President and CEO of Hansa Biopharma. Following the presentation, we will have a Q&A session. [Operator Instructions] As a reminder, all presentations will be limited to 40 minutes, including Q&A. We now turn it over to Soren. Thank you.

Thank you, moderator, and good morning or good afternoon, everyone, and thank you for your interest in Hansa Biopharma. Please turn to Slide 2. Before I start, I just want to point to the fact that this presentation contains forward-looking statements. And as such, you should apply the usual caution. Now please turn to Slide 3, a high-level overview of Hansa Biopharma. So Hansa Biopharma was founded back in 2007 as a spinout from Lund University in Southern Sweden. And 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. And also that, that could have a therapeutic application across a number of indication universes. And so our company was founded based on that. If you then fast forward 13 years, today, we're a late-stage clinical development stage company. We have our lead asset, imlifidase, for enabling kidney transplantation in highly sensitized patients under regulatory review in Europe, and we hope to have regulatory approval later this year. In addition to that, we have ongoing Phase II trials in indications, both in the transplantation space as well as in the autoimmune disease space. We are approximately 80 employees, mainly based in Sweden, but we also have employees across key European countries as well as in the U.S. We're listed on NASDAQ in Stockholm. We have a market cap of approximately SEK 5 billion. And we last raised capital back in November of 2018 and we're financed through mid-2021. Please turn to Slide 4. So just a few words about the mechanism of action of our lead asset, imlifidase. Imlifidase is produced by a human pathogen called Streptococcus pyogenes as part of its defense against the human immune system. And what it does is that it very fast and effectively cleaves IgG, all subtypes of IgG, specific to IgG, but it covers all subtypes of IgG. And it cleaves IgG just below the so-called hinge section creating a F(ab')2 and an Fc component and thereby rendering the IgG molecule inactive almost immediately. So essentially, if you look at the graph towards the right-hand side of the slide, within a couple of hours from a 15-minute infusion, you see IgG levels drop to below detectable levels, and they remain there for approximately 7 days before they gradually bounce back. And then within a month or so, you're back to normal. Please turn to Slide #4, I believe it is -- 5, sorry. So as I said, initially, the company was based -- was founded back in 2007. And over the proceeding 13 years, the main focus has been on developing the lead asset, imlifidas, for enabling kidney transplantation in highly sensitized patients. And we're very close to obtaining, we hope, a regulatory approval in Europe this year. We have, though, also already started to branch out, and we have ongoing trials in the first of a number of indication universes, where we think our platform may have applicability, namely autoimmune diseases. And so if you turn to Slide #6 and a high-level overview of our equity story. This platform, we think, is quite flexible and versatile and can be applied, hopefully, within at least 4 broad indication universes. Starting with the transplantation space, as I said, the first indication we're starting there is enabling kidney transplants in highly sensitized patients, but we're also studying posttransplant situations, and there are also potential indications for other organs, like heart and lung and potentially bone marrow. In the autoimmune disease space, as you know, there is a very high number of known diseases at this point in time, more than 100. Many of these don't have any existing therapeutic options available, and they're quite severe. IgG plays a role in at least a significant number of these diseases, and we're currently studying at least 2 of these diseases for potential use of imlifidase and also subsequently, we'll look at our next generation of enzymes for these. For these 2 broad indication universes, transplantation and autoimmune diseases, because the target audiences are quite concentrated, it's our intent to launch drug candidates coming out of our pipeline and getting regulatory approval ourselves. And thereby, we aim to capture the vast majority of the profit potential coming out of our efforts. Beyond autoimmune diseases and transplantation, we are also hoping to have a potential for our platform in gene therapy. There is a -- depending on what vector is being used for the transaction, there is a clearly established need for ways to work around neutralizing antibodies, either preexisting or antibodies that develop after repeat dosing. And so that's an area that we are currently studying. Beyond that, we're also already looking at oncology. Of course, recent developments there in the immuno-oncology space have been quite promising, but there clearly remains a need for more efficacious therapies. And one of the reasons why some of the therapies are not optimally effective today is because of competition for relevant receptors. And so it's thought that potentially, if IgG, which plays a role here, is being wiped out for a time period, then that could enhance the efficacy of these immuno-oncology therapies. So that's an area we're looking at. Both gene therapy and oncology are spaces where we are opting for a partnering strategy, obviously, because complementary assets are needed, but also because these are very large spaces, quite complex and costly to operate in. So here, we're already in discussions with a range of different potential partners. Now please turn to Slide #7, and a more granular look at the different indications and the steps we can take and target both for our first-generation enzyme, imlifidase, as well as those that are collectively called the next-generation enzymes and that we're developing for repeat dosing under the overall heading NiceR program. So for the imlifidase molecule itself, as I said already, we're active in transplantation and autoimmune disease space. We're focusing initially on the kidney in the transplantation space. But beyond that, we have, as I said initially, the lung, heart and also bone marrow that we could potentially target. In the autoimmune disease space, we have ongoing trials in anti-GBM and Guillain-Barre syndrome. But beyond that, there is a number of acute monophasic autoimmune diseases, like NMO or ANCA-associated vasculitis or lupus nephritis, for instance, where IgG plays a role and where imlifidase potentially could be a good therapeutic option. For our next generation of enzymes that we're developing for repeat dosing, again, we have the transplantation space, we have relapsing autoimmune diseases, oncology and repeat dosing gene therapy that are areas that we're looking at for this next generation of enzymes. Please move to Slide #8. So let me give a very brief overview of the results generated through our Phase II trials with imlifidase for enabling kidney transplants in so-called highly sensitized patients. We have conducted a total of 4 Phase II trials with a total of 53 patients. Transplantation or enabling transplantation was not an endpoint in all of these. So a total of 46 patients have been transplanted through those trials where transplantation was an endpoint or where, in 1 case, by chance, 1 patient was actually transplanted. And that represents 100% success rate in enabling transplantation in highly sensitized patients. And if we then look at the graft function at the 6-month time point posttransplant, the success rate there or the graft survival rate is 94%, which is in line with what you see in the general range of transplant patients, also non-sensitized patients. So a very good outcome there. Please turn to Slide #9. So based on these very encouraging Phase II data, we submitted a marketing authorization application in Europe, which was accepted for review back in the first quarter of last year. We are currently interacting with CHMP in the [ repertoires ], and we expect an opinion from CHMP later this quarter. If that is a positive opinion, the European Commission would adopt that in Q3. And we're already getting ready for a potential launch in Q4 in Europe. In U.S., the FDA has insisted on us conducting a randomized controlled trial prior to submitting a BLA. We have agreed with the FDA on the overall design of such a trial. And we're getting ready to submit the study protocol this quarter. And if approved by the FDA, we should be able to enroll the first patient later this year in Q4. Please turn to Slide #10. And I think I'm going to skip this because this is just a more granular overview of the regulatory process in Europe. I already talked to that. So please go to Slide #11. As I said earlier, it's our intent to launch imlifidase for enabling kidney transplantation in highly sensitized patients in Europe ourselves. We already have the core commercial infrastructure in place. We have MSLs, who've been out there in the field for a while now, interacting with the key clinics and key opinion leaders in the space, talking about the overall disease and challenges. And we're ready to ramp up the commercial infrastructure just ahead of a potential launch later this year. It is a highly concentrated target where, if we look at the major countries in Europe, essentially 70% to 80% of all kidney transplants are handled by a handful of clinics in each of the major countries. So we don't need to establish a very vast infrastructure of sales reps or MSLs to effectively and efficiently promote imlifidase for this indication in Europe. And we'll go essentially center by center. We have a clear list of the key centers that we're targeting, focusing on those centers initially that have not only the largest volume but are also most likely to become early adopters and generate positive experiences early on with the appropriate patients. Please turn to Slide #12. So the market in Europe and potential in Europe is overall relatively similar to the potential in the U.S., approximately 20,000 kidney transplants take place across the EU. If you just look at the EU5 plus Sweden and Norway, it's approximately 16,000 kidney transplants that take place every year. And there is some variance from country to country as to what proportion of patients on dialysis are put on the wait list for a potential kidney transplant, and again, what proportion of patients on the wait list are then actually transplanted on an annual basis. But if we look at the biggest countries like Spain, Italy, the U.K. and France, it's -- Germany also, it's between 2,000 to 3,000 transplants that take place every year. Currently, not a lot of highly sensitized patients are transplanted, certainly in the deceased donor situations, because generally, desensitization does not take place given the lack of effective and safe therapies. But of course, if it is approved, that will change the dynamics. So this overview, essentially, provides a good idea of the potential if you look at the deceased donor transplants taking place on an annual basis in Europe. Please move to Slide #13 and an overview of our pipeline. So as I said initially, we're focusing across a range of indication universes. We are further ahead in the transplantation space with imlifidase for enabling kidney transplantation in highly sensitized patients. In addition to this indication, we already have a second ongoing Phase II trial, namely the posttransplant setting for kidney transplant patients. Now approximately 10% to 15% of all these kidney transplant patients experience episodes of acute Antibody Mediated Rejection. These episodes are generally treatable but not optimally, and we think that imlifidase, because it acts so fast and effectively, might be a very good addition to the range of options available. So we've initiated a Phase II trial in that indication -- Moving on, then we have 2 ongoing trials in the autoimmune -- the acute autoimmune disease space. Anti-GBM is an ultra-rare, very severe disease also affecting the kidney primarily. In some cases, also the lung, but primarily the kidney. There is no approved therapy, currently. It affects approximately 1.6 out of 1 million and it's very severe, 2 out of 3 patients lose the kidney function and end up on the wait list for a kidney transplant following an episode and attack. It's a monophasic attack, so you essentially only have 1 attack. And if you deal with that successfully, you're unlikely to have a second attack. The second acute autoimmune disease that we're starting is Guillain-Barre syndrome, which is triggered by an infection. It's also quite severe. Mortality rate is 3%, 4%, 5%. Up to 40% of patients end up in respiratory support. IVIg is used today, plasma exchange as well, but is not highly effective, which is why you see these mortality rates, and it takes a long time to recoup from an attack. So we have an ongoing Phase II trial in that indication as well. Imlifidase, despite its effectiveness, has 1 problem, and that is the fact that it's immunogenic because it comes from a human pathogen. So we're not really developing it for repeat dosing. There we have the so-called NiceR program. You see that on the slide here, where we're developing enzymes with a targeted similar efficacy profile, but able to be re-dosed. And we have a lead candidate, which has been selected, and we're currently preparing for IND-enabling tox studies. And hopefully, we should be able to move into the clinic at some point next year. Finally, our oncology program under the heading EnzE is still in preclinical development, and we're moving towards potential proof of mechanism there. Please move now to Slide #14. So if we look at the status of the ongoing Phase II trials, enrollment in the anti-GBM study has now been completed. That happened in January of this year. We expect to have last patient last visit later on this year, and we should have a high-level readout from this study in the third quarter of this year, which we look very much forward to. The Guillain-Barre syndrome study has currently enrolled 4 patients out of a targeted 30. Because of the COVID-19 crisis, there is a delay in enrolling patients. We're are not currently enrolling patients into the study. And so we expect that study to be fully enrolled in the second half of next year. In addition to Guillain-Barre syndrome, we're also -- and anti-GBM, we also have an ongoing study, as I said, in a more indication for kidney transplant patients. And here also, we have 4 out of the targeted 30 patients now enrolled. And similar to the GBS trial, we expect this study to be negatively impacted in terms of the patient enrollment rate by the COVID-19 crisis. And here, we expect this study to be fully enrolled in the first half of 2021. Please now move to slide number -- what is this? Can't see the number. I can't see the number. It's the slide titled NiceR, new set of enzymes for repeat dosing. So the way that we're developing this is we're developing this for situations where repeat dosing is necessary and where you need maximum impact. For instance, in connection with flares for chronic autoimmune diseases. Typically, you have these flares. And in these situations, you would want optimally to have immediate impact. And so the maintenance therapy, whatever it may be, is not sufficient. And we think that then the next-generation enzyme that we're developing could be a very relevant option because you would have impact immediately essentially, as indicated on the graph on the right-hand side of this slide. Please move to Slide #16. Gene therapy is an area that we think could be very relevant for our technology. Again, as I said initially, depending on the vector that's being used, but in particular, if you're using an AAV vector, there is very often issues with neutralizing antibodies that leads to exclusion of patients that would qualify for therapy. And we think that imlifidase and also follow-on enzymes could be a very good option in that situation. So we're currently in discussion with a range of players in the gene therapy space and hope to move forward here with a specific program. Please now turn to Slide #17. Let me just finish by looking at the financial situation. As I said initially, we last raised capital back in November of 2018. And we're currently -- coming out of this quarter, we're currently well financed through mid-2021. Finally, let's look at the upcoming milestones. In the immediate future, of course, a very important milestone ahead of us is the potential approval in Europe, which could happen as soon as Q3 of this year and then a subsequent launch in Q4. Looking into '21, we expect the MR study, again, depending on what happens with the COVID-19 situation, but we expect that to be fully enrolled during the first half of the year. We also expect to take our lead candidate from the NiceR program into the clinic at some point in '21. And towards the end of '21, we should have the GBS trial fully enrolled. Then we should have data readout in 2022 from both the AMR studies -- study and the GBS study. And we should also finalize the U.S. trial for imlifidase in kidney transplantation in highly sensitized patients with a potential BLA submission in 2023. So with this, I will conclude the presentation and turn it over to the moderator and hopefully questions. Moderator?

Great. Yes. Now we will move on to the Q&A portion of the presentation. [Operator Instructions]

Are there any written questions or...

Okay. Our first question, is the COVID-19 pandemic affecting any of your future milestone time lines?

Well, only as I talked to, right, so certainly, enrollment in our ongoing trials is impacted by COVID-19, and we expect a delay of 3 to 6 months on both the GBS and the AMR trials. So far, we have not seen any impact on the regulatory interaction we've had or we are having with both the EMA and the FDA. And so as far as the next trial in the U.S. for imlifidase, we do expect to start that trial in the fourth quarter of this year. But of course, it's not possible to fully predict what will happen down the line.

[Operator Instructions] We'll give it another minute to let the questions come through. Okay. Our next question, have you played a role in the development of any testing or vaccines for the COVID-19 virus?

No. We have not been involved in any trial activity around a vaccine for COVID-19.

Okay. We have no further questions. We'd like to thank Søren from Hansa Biopharma for presenting today, and thank you all for attending the 2020 Virtual UBS Global Healthcare Conference. You are now free to disconnect from the conference line. Thank you.

Thank you.