Hansa Biopharma AB (publ)

This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are designed to help you navigate the audio should the corresponding text be unclear.

The machine-assisted output provided is partly edited and is designed as a guide.:

0:21 Thank you. Good afternoon.

Good morning. Welcome to Hansa Biopharma conference call on the results from the first nine months of twenty twenty one.

I'm Søren Tulstrup CEO of Hansa Biopharma. With me today, I have our CFO, Donato Spota; as well as our Head of Investor Relations, Klaus Sindahl.

00:40 Today, we'll review the overall progress and some highlights of our business in the most recent quarter and provide a preview of our near-term milestones. Our presentation should take around fifteen to twenty minutes and after that, we'll take your questions.

00:56 Please turn to slide two. Please allow me to draw your attention to the fact that I will be making forward-looking statements during this presentation, and you should therefore apply appropriate precaution.

01:06 Please turn to slide three. Hansa Biopharma's transformation into a fully-integrated commercial-stage biopharmaceutical company has become reality this year and we are on track to deliver our key objectives for twenty twenty one as well as on our strategic priorities to build tomorrow’s Hansa.

Throughout the year, we made significant progress advancing our clinical, commercial and corporate strategy with solid progress in our efforts to build and advance pipeline of valuable drug candidates for rare immunologic diseases while in tandem to introducing an Idefirix in Europe as a new transformative therapy that brings hope to the thousands of highly entitized patients across the continent, who are currently waiting for a compatible kidney transplant. 01:53 During the third quarter, we made good and steady progress with the commercialization of Idefirix in Europe.

As we've discussed before, Idefirix represents a paradigm shift in the transportation ecosystem and as such, there is much foundational work to do in establishing it within the system. We made important advancement towards obtaining Market Access in a number of key markets and funding has now been secured in the first three countries.

In total, we have now submitted Health Technology Assessment dossiers in ten countries. These dossiers are an important component of successful product launch as to support pricing and reimbursement, which human of which is obviously critically important for subsequent market penetration.

02:40 The submitted filings include data demonstrating the uniqueness of Idefirix from a clinical perspective, various country-specific demographic datasets to define the eligible patient population based on the drug's approved label, as well as proposed pricing based on the overall value proposition. Recent assessments in Sweden and Germany concluded that Idefirix would be a cost-effective and potentially even a cost-saving drug versus standard-of-care, which is a rare event for orphan drugs.

03:10 At the end of August, we participated in the twentieth addition of the European Society Organ Transplantation or ESOT Congress, which was held in Milan and Italy. The ESOT Congress was a first in-person to end post-COVID and the Hansa team had a strong presence which included a sponsored symposium.

One of the key outcomes from ESOT was the information of new workstream with leading transplantation key opinion leaders to advanced clinical guidelines in transplanting incompatible kidney transplant patients. 03:41 The new ESOT works streams is expected to be a key driver for harmonisation in approach to transplanting highly sensitized patients and to ensuring positive outcomes for patients and transplant programs.

We will later discuss in more detail how we track progress towards commercial success and which metrics to look for as the company advances its commercial loan strategy and kidney transplantation. 04:06 In the U.

S. we have now initiated the first site in San Antonio, Texas, for recruitment of patients to our randomized controlled clinical trials in kidney transplants, the so-called Confides study and we expect patient enrollment to commence in the fourth quarter.

Initiation of Confides is a significant milestone in our efforts to access the important news at U. S.

Market. The new trial will enroll sixty four highly sensitized patients with a cPRA score of ninety nine point nine or above, representing the group of patients with the highest unmet medical need.

We expect to enroll patients at twelve to fifteen leading transplantation centers across the U.S. and that the U.S.

trial will generate valuable experience at these key clinics ahead of our potential approval and commercial launch in the United States. 04:54 Looking beyond transplantation, we now initiated discussions with the FDA and anti-GBM program, following the successful completion of Phase 2 which demonstrated very encouraging clinical data in first area outside transportation for imlifidase.

As previously guided, we aim to achieve alignment with the FDA on the regulatory path forward in anti-GBM later this year. 5:16 In our ongoing Phase 2 programs for GBS and AMR, we’ve seen patient and recruitment accelerate as new centers were initiated during the third quarter and we are on track to meet our target on competing enrollment in both studies towards the end of this year or first half of next year as previously guided.

Further, I'm also pleased to announce a new study in twelve patients in the U. S.

To assess whether whether imlifidase in combination with pharma therapies can optimize patient outcomes and highly sensitized patients pieces with donor specific antibodies rebound and antibody-mediated kidney transplant rejection. The study will be run at the New York University Langone Transplant Institute and is expected to commence next year.

06:00 Lastly, I also want to highlight that Hansa Biopharma was recently awarded certification has a great place to work for the second consecutive year. The Certification as great place to work reflects our successful efforts over the past years to not only build and maintain a high performance team, but also to create a rewarding and stimulating workplace for our employees.

06:21 Please turn to slide four. As I said initially, Hansa Biopharma’s commercial launch activities are progressing as planned.

Our goal is to have a positive impact on patients as we work closely with the transplant community to reshape the area of desensitization and integrate Idefirix into clinical practice as a new standard-of-care. With this novel therapy, we are painting a new path in changing the transplantation ecosystem to accommodate transplants for incompatible kidney patients and we do this in a very focused way clinic-by-clinic.

We are taking this strategic approach as Idefirix is the first and only approved drug to enable kidney transplants in highly sensitized patients in the EU were incompatible with a deceased donor and the long-term market uptake of this innovative product is highly dependent on successful early experiences in key early adopter clinics. 07:16 We measure launch progress using a set of key commercialization metrics which directly impact future adoption for sales of Idefirix as a new transformative therapy.

Securing appropriate pricing and reimbursement at the right price level and on-label is one of the key metrics for the rollout of Idefirix. We are on track to secure funding market-by-market in Europe as indicated by the recent successful and completion of HTA assessments and negotiation procedures can first with the early launch countries mainly Sweden, Finland, and Netherlands.

07:50 Further to this, we’ve initiated additional HTA and reimbursement processes across seven countries, including United Kingdom, Germany, Norway, Denmark and Israel and most recently also in Italy and Scotland. By year end, we expect to have completed HTA filings in all of the five largest European markets as HTA dossiers are being prepared for submission in France and Spain during the fourth quarter.

08:16 I also want to highlight that we now submitted Marketing Authorization Applications in both Switzerland and Israel and that Idefirix has received status as a priority medicine in Poland, which potentially will need to accelerate access. On the clinical side, we've been working with a number of priority centers to ensure and optimize their clinical readiness as a number of new compatible patients are being identified and prioritized for kidney transplantations in the coming period.

08:46 So far, nine clinics are considering clinically ready to take on highly sensitized patients for incompatible kidney transplant, and we continue to work closely with an additional nine centers across Europe on their preparedness through training, key opinion leader engagement protocol drafting and logistics. 09:04 In relation to the awareness and interest metric, we have extensively engaged during the recent quarter, especially after the easing of COVID-19 restrictions as exemplified by our significant presence at the European Society for Organ Transplantation Congress, which was held in Milan, Italy in August.

At this Congress, we held a very well attendance symposium entitled, a roadmap to transplant for the highly sensitized patients, hosted more than thirty key opinion leader meetings with our combined commercial and medical teams and had two oral presentations in support of Idefirix. 09:38 We're very pleased with the great interest from key opinion leaders throughout the Congress and one of the key outcomes from ESOT was information of the new workstream with leading transportation, key opinion leaders to advance clinical guidelines to include the incompatible kidney transplant patients.

The new ESOT workstream is expected to be a key driver for harmonization in the approach to transplanting highly sensitized patients and so ensuring positive outcomes for patients in transplant programs. 10:05 Now please turn to slide five.

Turning now to our clinical programs in antibody mediated rejection and Guillain-Barré Syndrome where patient recruitment in the two Phase 2 programs has been accelerated during the third quarter, driven by the initiation of additional recruitment centers. In the AMR trial, seven patients were enrolled during the third quarter, which takes the total number of patients up to nineteen out of a target of thirty.

Since July, we have increased the number of active sites in AMR from seven to twelve and expect two additional centers to be open in the fourth quarter. 10:44 With the current pace for patient enrollment, we're well on track to completing recruitment towards the end of this year over the first half of next year at the latest.

We expect to announce the first data readout in the AMR Phase 2 study in the second half of twenty twenty two as previously guided. 10:59 In the GBS trial, we now enrolled fourteen patients out of the target of thirty patients.

During the third quarter, we've added one additional center and expect two additional centers to be initiated during the fourth quarter. As previously guided, we expect enrollment in the GBS trial to be completed towards end of this year or perhaps first half next year at the latest with the first data readout in the second half of twenty twenty two.

Enrollment into both of these studies is ongoing under a risk based side by side approach and given the volatility in the situation, we are facing related to COVID-19, our guidance assumes no further escalation of the COVID-19 pandemic, potentially forcing trial centers reprioritize patient recruitment or even shut down again. 11:46 Moving on to our anti-GBM where a dialogue with FDA has now been initiated regarding the regulatory path forward towards BLA in the U.

S. The dialogue with the FDA is expected to conclude later this year as previously guided.

Similarly in Europe, the construction regulatory advise meeting was recently held BfArM. Hansa is now preparing for a dialogue with EMA around the regulatory path forward towards Marketing Authorization Application in Europe in anti-GBM.

12:16 Last year, very encouraging Phase 2 data was presented in anti-GBM, demonstrating that two thirds of the anti-GBM patients enrolled achieved dialysis independence six months after treatment. As I mentioned earlier on this call, we've just initiated the first center in our new Confides trial in kidney transplantation in the U.

S. at the San Antonio Methodist Hospital in Texas.

12:39 The U. S.

Trials will target sixty four highly sensitized patients with cPRA Score of ninety nine point nine percent and above representing the group of patients with the highest unmet medical need. We expect to initiate additional centers in the coming months, aiming at twelve to fifteen leading transportation centers across the U.S.

As previously communicated, we expect to compete enrollment in the second half of twenty twenty two with a twelve month follow-up on eGFR completed by second half of twenty twenty three. Results from the trial are expected to support a BLA under the accelerated approval pathway in the first half of twenty twenty four.

13:18 Please turn to slide six and a summary overview of our pipeline. As depicted on this slide, thanks to continued progress over the past few years.

We've developed a broad clinical pipeline in both transplantation and autoimmune diseases. In addition, we have excited preclinical projects ongoing in cancer and anti-drug antibodies as well as in the very promising field of gene therapy where our partnership with Sarepta is assessing imlifidase as a pretreatment to Sarepta's gene therapy programs in Duchenne and Limb-Girdle Muscular Dystrophies.

13:52 Preclinical development is progressing according to plan, and upon successful completion, we expect imlifidase to move into the clinic as a next step. Beyond the partnership with Sarepta, Hansa is also engaged in a preclinical collaboration with argenx, which is also moving forward according to plan.

The focus of the argenx collaboration is to assess the potential benefits of combining imlifidase with efgartigimod, argenx's FcRn inhibitor. With this overview, I will now hand over the call to Donato, who will take us through a review of the financials for the first nine months.

Donato, please.

14:28 Thank you, Søren. Please turn to slide seven.

Søren, outlined, we are on track to achieve our key twenty twenty one objectives through continued progress across our business and pipeline activities. Revenue for the first nine months of twenty twenty one grew to eighteen point five billion Krona including six million Krona in product sales and ten point four million Krona in revenue recognition under the Sarepta agreement.

14:53 Please turn to slide eight. We continue to invest in the Idefirix launch and our pipeline in an accordance with our operational and financial plans.

For the first nine months of twenty ninety one, SG&A expenses amounted to two twenty four million Krona compared to hundred and forty million Krona from the same period last year. The increase is in full support of our objectives to develop Hansa into a fully integrated biopharmaceutical company and such [Indiscernible] reflects our expansion commercial activities including investments in the territories, marketing, Market Access, and supply chain activities related to the long Idefirix in Europe.

15:36 Our investments in R&D amount to one hundred and sixty three million in Swedish Krona for the first nine months of seven twenty one, which is above the same level as per previous year. Investing in R&D and our pipeline activities across all of our therapeutic areas remains the key priority for Hansa and as it's supports long-term value creation for the company.

16:02 The net loss for first nine months of twenty twenty one was three hundred and eighty five million Krona compared to three fifty million Krona for the same period last year. The increase is primarily driven by an increased activity and ramping of our commercial activities and developing Hansa to a fully integrated company.

16:22 Please turn to slide nine. Cash flow for operating activities amounted to minus three hundred and sixty five million Krona for the first nine months of twenty twenty one, which compares to minus hundred and ninety four million Krona from same the period last year.

The increase should be seen in a context of ten million U. S.

dollars upfront payments received Sarepta, July last to year on our license agreement for Sarepta. 16:49 As of September thirty twenty twenty one, Hansa’s cash position including short-term investments amounted for one billion Swedish Krona corresponding to approximately hundred and fifteen million U.S.

dollars. From a solid cash position and projected run rate we expect Hansa to be financed into twenty twenty three as previously guided.

17:09 And I'll hand back to Søren to give you remarks.

17:14 Thank you. Donato.

Please turn to slide ten. Hansa Biopharma’s transformation into a fully integrated commercial stage biopharmaceutical company has become a reality in twenty twenty one and we continue to demonstrate solid progress in our clinical, commercial and corporate strategy including significant progress in our efforts to build and advance the pipeline for valuable drug candidates for rare immunologic diseases.

17:39 Looking at the milestones ahead, we expect to announce the first patient enrolled in the U. S.

Confides Trial during the fourth quarter, following initiation of the first recruitment site in Texas. As discussed, results from the trial are expected to support a BLA under the accelerated pool path trade in the first half of twenty twenty four.

In addition, as also discussed we aim to conclude our dialogue with FDA on a regulatory path forward for our anti-GBM program later this year as previously guided. 18:11 In our two Phase 2 programs in the AMR and GBS, we've seen an acceleration in enrollment rate in new patients following the addition of more centers.

At the current pace and assuming no further escalation of the COVID-19 pandemic, we're well on track to completing recruitment towards the end of this year or by first half next year the latest as previously guided. Following completion of enrollment, we expect to announce the first data readout from both studies in the second half of twenty twenty two as previously guided.

18:43With regards to NiceR program for repeat dosing scenarios, we expect R&D enabling stock studies to be completed in twenty twenty two. Upon unsuccessful completion of these studies, we expect advance the NiceR program into clinical studies.

We look forward to keeping you updated on our progress in advancing our mission to bring lifesaving, life-altering therapies to patients with serious rare diseases while generating long-term value for our shareholders and society at large. 19:11 Please turn to slide eleven, with this, we're now ready to take questions.

Operator, please begin.

19:33 Hi there. Thanks for taking my questions.

So, you've been guiding expectations lower for over a year, I guess giving everybody plenty of times get used to the idea, but your negative gross margin on Idefirix, not only in Q3 but also from obviously – but also from before for the whole year, I mean, looks like possible signal that demand is not met internal projections. So would you please comment on how your expectations may have changed in the past twelve months and at what level your assumptions have changed is demand a factor here at all?

Or is it just access and how confident are you that sales will finally start again in Q4? Thanks.

20:19 Well, thanks, Christopher for that question. So, no, our internal forecast have not changed.

This is due to the fact that obviously when you produce, you need to produce pretty big batch sizes, and we want to make sure that we have product available in any – on any circumstances, the last thing you want is to not to able to supply a market like to our internal forecast are totally consistent over the past year and so there's been no change in that. We are very confident that that as I said earlier in this call that we've made a good start to the launch, we're seeing very, very solid corpus versus the key launch metrics, and we certainly expect those to pick-up and follow the S-shaped long curve that I've been talking quite a lot about over the past two year or two.

21:09 Okay, perfect. Thanks.

Sort of just another follow-up question. Do you need to add manpower experience to your Market Access, marketing or medical affairs teams to get that pickup to happen?

Do you feel that you're adequately staffed there?

21:33 Well, I'm very pleased with our Market Access team that really has done a fantastic job getting Market Access programs going. We may need to staff up, as we spread out geographically, but at this point in time, we have the capacity need to handle the submissions as I said we've submitted now in ten different countries, and we have ongoing discussions and many key countries.

As far as medical and commercial staff is concerned. There will be some additions as we get into specific markets.

Currently we have the core team in place, and overall it’s a little double digit number, but they are doing again an excellent job in the key markets interacting with the clinics but of course over time as we get access to regional countries there will be some additions at the front-end.

22:29 Okay, thanks. Really appreciate that.

If I can just ask one more before getting back in the queue. Desensitization with previously available methods has gone out of favor to some extent over the years.

What's the latest feedback you get from across the nephrology community around Idefirix being the answer to desensitization needs? And I guess when it comes to the ESOT workstream.

Can you give a little bit more background? How is that related to guidelines?

What are the steps you need to take to get into guidelines? Thanks.

23:10 Yeah, Sure. So you're right.

I mean, desensitization has not really been at the top of the list in Europe for a number of years for variety of reasons. So this is also why we're stepping into what is somewhat of virgin territory here.

But overall, I would say the feedback and the reaction to Idefirix has been very, very positive throughout Europe. I have also interacted with quite a number of key opinion leaders over the past year or two, and I would say that we definitely see a high degree of interest.

Obviously, that should not be taken as a signal that you will see very, very strong uptake in Italy, but I'm really, really pleased with the interest that we are seeing. 23:55 You mentioned the ESOT, the guidelines, and as I talked earlier on this call, we're very happy that our workstream, a formal workstream has now been formed within the society to put in place European-wide guidelines for desensitization of these highly sensitized patients, because that will be very helpful going forward.

It's not necessarily short-term to get started. We have direct interaction, of course, with key clinics and national societies, but it will be helpful to have European-wide guidelines and again, just looking at the discussions that took place at ESOT, in this team that has been set up, I was pleased with the degree of consensus that we need to do better in Europe here and that there's much more to be done and that the society has a key role to play.

So the next step will be obviously to get this workstream going, and then to have the guidelines submitted for publication at some point in the not-too-distant future, I would expect.

24:58 Okay. Thank you very much.

I'll get back in the queue.

25:01 Thanks, Christopher.

25:09 Hi, guys. I'm Dominic from Intron Health.

Thanks for taking my questions. My first question [Indiscernible] since taken on a second.

And if not then when would you expect to? Question two is just on the quarterly P&L, I was wondering around the cost of revenues was so high this quarter.

And finally question three, just wondering again whether you have received any negative feedback from the first transplant center [Indiscernible] phase. Thanks.

25:40 Yes, on the first question, I will hand over to Donato for the second. The first question, whether any centers has taken on a second patient, the answer is no.

That is obviously something that we're looking at to have repeat business and when I'm talking about repeat business, it's not at the patient level. Of course, it's at the center level.

But we expect some of the most important centers to have, hopefully, the first patient this year, and then they will typically wait for a number of months to see the outcome before deciding on potentially doing the second and subsequent patients. 26:21On the – let me take the third question which was on negative feedback, and at this point in time, we've not received any of that.

So, so far, really good interest, positive attitudes, and most centers are getting ready to transplant their first patients. And on the second question, I'll hand over to you, Donato.

26:48 Yeah. Sure.

Certainly. I think your question goes in the same direction as business question.

At the end of the day, I mean, this is – looking at the [Indiscernible] isolation, this is really an accounting topic mainly [Indiscernible] we have been delivered additional material. So – and in this case, you have to do certain tests, I mean, from an accounting perspective to evaluate whether you can show the amount on your balance sheet.

And obviously, since we don't have a history of sales, you basically do a provision, and this is what you see in the accounts on the cost of sales. I think important for you to note in this context is a few things; A, I think this is completely not unusual if you compared to similar companies like Hansa, who are just launching their first product; and secondly, the material, while this is provisioned, material has not been discarded or so.

This is obviously still prior material, and we will – if there's sales, we will use the material to sell it. So, it's really just an accounting topic at this point.

28:01 Okay. Thank you.

That's great. That's very helpful.

I suppose longer term thinking about Cogs, a product like, you'd expect the gross margins to be pretty high. I mean, are we looking at kind of north eighty five percent for that?

28:14 It's most guided exactly on what the gross margin is going could be, but generally speaking I think, whatever your interpretation of pretty high is, but we will have soon a healthy gross margin from that product, yes.

28:28 Okay. Thanks very much.

28:39 Yes. Thank you guys for taking my questions.

Two on my side. First, on Idefirix, can you maybe clarify a little bit the way you're going to take in France.

Will you go through the normal process submit the dossier with GHS or would you try to take advantage of the new early access scheme that has been setup in July maybe to go faster. And another one on the current Phase 2 in AMR.

Just curious about the thirty patients, will you do a kind of satisfaction between patients having pre-existing DSA and patients who will develop de novo DSA and what kind of analysis you will perform in this population, just maybe to understand better the data that you could get in the next pass after the result the [Indiscernible] phase 2? Thanks.

29:39 Well, thanks, [Indiscernible] On your first question, the approach to France, you're right, I mean, there's this new early access program pathway available in France which certainly is something that we are looking at. At the same time, even [Indiscernible] also exists.

So, we will certainly move forward in France. And I can't say specifically to what extent we'll make the early access program pathway an option that we'll exploit at this point in time, but certainly, it's a possibility, yes.

As far as the AMR studies is concerned, we will discuss it in more detail when we get into next year [Indiscernible]. And so, if you will have a little patience, I think you'll get more insights there.

[Technical Difficulty]. Was that okay?

Operator?

30:53 Yeah, I can hear you. I don’t know, we just lost.

Obviously, I think we lost the conference [Indiscernible].

31:24 Hi. Thank you for taking my questions.

Apologies if these questions were asked before, but I've missed the start. Two questions from me, please.

The first one, on the clinical readiness, you mentioned nine centers are ready, can you elaborate a little more what this means exactly? Is that imlifidase now is included in the clinical guidelines and physicians are aware and willing to use the drug, so the centers basically are ready for the eligible patients?

And then the second question, based on your discussion so far with the centers, how much of a hurdle or need for education is to convince to include the desensitization with imlifidase and can you give us an estimate of what you think is the current desensitization rate, and what is your aspiration of how much this can increase in the next two to three years? Thank you

32:26 I'll probably need to have you repeat your second question, but in the meantime, let me just try to answer the first question, which was on what is clinical readiness mean as far as the centers are concerned? And that really means that the centers' key employees, key staff, have been ongoing training that we've certainly been involved in very deep dialogue with the staff around how to treat these patients, how to identify appropriate patients, et cetera.

So that is a pretty extensive interaction that needs to take place upfront because obviously we're as interested in successful outcomes as are the centers and the patients clearly. 33:13 Second, we also want a specific – or not we, but certainly, the hospitals specific protocol to be drafted and put in place for how to approach all of this, and then obviously specific logistics around how to get the product in and handle the product in a transplant situation.

So those are some of the key steps, but we really have a very, very granular protocol overall, if you will, for our own sake, to move forward in our interaction with these centers and make sure that they're ready to transplant. So this is really managed at a very detailed level on our end.

33:54 The second question, if you can just repeat it? It was around how we expect desensitization rates to increase, and can you repeat, because the audio was a little bit bad, so I didn't get all of it.

34:04 Yeah, sure. So, I'm wondering if the desensitization because desensitization is part of using imlifidase and I wonder so far with the discussion with the centers that trying to include it in the clinical guidelines.

How much of the hurdle or education centers need to use it and if you have enough [Indiscernible] the rate of the desensitization so far as a baseline and where do you expect this rate to increase in the next three years with the education that you're going to in the clinical awareness?

34:43 Yeah. So, reality in Europe is that right now, there is very little desensitization taking place.

Looking at these very highly sensitized patients and trying to make them eligible for potentially lifesaving kidney transplants. That just doesn't really happen because you don't have any approved product and you don't have nonapproved products that are able to get the kind of decreasing in donor-specific antibodies rapidly to enable patients to undergo a kidney transplant when a deceased donor organ becomes available with a positive cross-match.

So essentially, as I said, we're walking into a virgin territory here and this is also why we need to talk, not just about our own product, but the whole field of desensitization. And that is a process which has started and, as I said, we are very comfortable and happy with the progress that we've seen, the reception within the medical societies, including the European Society for Organ Transplantation, where they've now created this very focused workstream that will specifically look at guidelines for desensitizing highly sensitized patients, and this is all in the back of the emergence and the availability of Idefirix as a transformative therapy, right?

So, this is what is happening at this point in time.

36:07 Okay. Thank you.

36:10 Thanks.

36:18 Yeah, Hi, there. Thanks.

So what's the status of the confirmatory trial that you need for the EU for kidney transplantation and how important is it to your marketing strategy. That's my first follow-up.

And then the next one is how much influence coming out to the broader pipeline? How much inflows do you have on recruitment rates in the IISs?

You talked about potentially starting a trial for stem cell transplantation and potentially other indications given that IISs have so far proven to be a slow to go, how do you think about what your development strategy would be for any new indications? Thanks.

37:05 Good questions. Thanks, Christopher.

And so, first on the post-approval efficacy study, which is starting with one as a confirmatory trial in Europe, we are finalizing the last steps and we expect those to be ready to be initiated by the end of the year essentially. As far as the importance of this study, obviously, we need to run it and say, it's significant on our side, but it's also a good way to develop, experience in some of the countries in Europe where it will take a little bit longer to gain access, right, so that we have the second way of generating, hopefully, positive experiences in key centers.

So, that's where we stand with that trial. Your second question is also a good one.

You're right, investigator initiated trials tend to be a little bit slower in recruitment rates and so on. Obviously, as a company, you have less influence there.

So going forward, we will – we aim to run key trials ourselves, but they will be complemented by some of these investigator initiated studies for certain indications. So, it will be a combination going forward.

38:27 Okay. Thanks very much.

And just to be clear, the post approval efficacy study that will be separate from the FDA, the study for the Fda?

38:38 Yes. That's a separate study that European protocol only.

The FDA study has been a separate U. S.

trial that we initiating following good interaction with FDA, we aligned on the start protocol and the pathway being forward. So let's that's U.S.

only for trial, the Confides trial.

38:57 Okay. Thanks.

And do you have a rough indication of how many patients you need for the European one?

39:04 For the European one, we expect over the years to include approximately one hundred basis.

39:11 Okay. Thanks so much.

39:13 Thank you.

39:24 Thank you. This is a follow up question.

I was just taking very specific. You have so far with the U.S.

Trial, one side active, and the intentions to have between twelve to fifteen sites active. Can you tell us how many more sites you expect have active by the year-end?

And by when we should expect to see all size up and running? Thank you.

39:50 Yeah. So you are right, we expect twelve to fifteen centers.

It's a little bit tricky to give you a hard number for how many centers we would expect by the end of the year. Obviously, this is an ongoing process.

I would expect a couple of more centers to get active in the near future and that's obviously relatively soon into – or early into the following year that we'll have the bulk of the centers of running. There is very strong interest from these key centers to participate and so I don't think – it's certainly another question of motivating them, but there's obviously a number of steps needs to take them through.

So that's why I can say at this point in time.

40:37 Okay. Thank you.

So we'll wait for more updates. Thank you.

40:40 Okay. Thanks.

40:51 Hi. Thank you for taking my question.

Just the one for me if I could. Just on the work with the ESOT workstream that you were mentioning and in regards to developing clinical guidelines and imlifidase in the renal transplantation indication.

You were saying you hope to kind of complete that work during twenty twenty one as I understand. I'm just looking for a bit of clarification whether that would mean kind of completion of drafting of potential clinical guidelines or kind of how what work needs to be done post the completion of this ESOT workstream before there could be kind of clinical guidelines in place that would be implementable in broadly in Europe, I guess?

41:44 Yes. So the taskforce has now been set off as I said, and they're getting going as we speak.

Obviously, the next step will be to produce a draft that will need to be circulated within the wider community and the usual review and so on. I expect this to take months and I really can't predict obviously when this will be completed.

But if there are not too many discussions and so on, it shouldn't necessarily take very long. Upon completion of this internal peer review and agreement on the final version, it will need to be submitted for publication and so on.

Again, I can't give you a hard date or specific kind of status by the end of the year, but I expect this to take some months. And as I said, the good thing is that there is clearly alignment within the society that they need to produce these guidelines that they will be helpful.

And my reading of this situation is that there is not too much disagreement along how they would look like, but this is a scientific society and as ever it's impossible to predict what will come out of it, but we are certainly encouraged by what we've seen so far.

43:06 Great. Thank you.

Maybe just a second question if I could perhaps a difficult one for you to comment on. Just now, it was an update that came here during the call but another Swedish company, Genovis has entered into a licensing agreement that Selecta Bioscience to develop IgG proteases for using gene therapy in autoimmune diseases.

And I was wondering whether you have any kind of sense of how similar their approach is to what you're hoping to do imlifidase in gene therapy and in autoimmune diseases and then whether you can kind of comment on potential similarities or differences between those programs if you're able to at this early stage?

43:56 No, I'm not able to comment on that and Genovis, but I would say that there obviously a number of different approaches in this space and we're very very very comfortable with the unique approach that we are taking. So that's what I can say general.

44:12 Great. Thank you.

44:47 Hi. Good morning.

Thanks for taking the questions, and I apologize because it's already asked in the top. But just in terms of the targeted centers that you're in, what's your sort of overall target in terms of the percentage of transplants taking place in Europe over time, and certainly in the key markets?

I mean, are you going to be covering ninety percent of the overall transplant volume or is that sort of – or the target can be a little bit lower? Thank you.

45:20 Well, I mean, as we have discussed in the past, this is a very, very concentrated target audience. So in some countries, we only have one clinic essentially doing all the kidney transplants, like in Norway for instance, where there is a center in Oslo.

There is one center only in Finland. In some of the larger countries, the top five or so represent seventy percent to eighty percent of kidney transplants.

And certainly, we would target the key centers. So, we do target centers representing the bulk of the kidney transplants through our efforts, but it's a low number overall.

46:01 Okay, great. Thank you.

And then just Søren, the timeline for actually bringing center online is fully training them, how long does that typically take from when you first show up to when they're able to tell you [Indiscernible] for that?

46:18 It’s difficult to say at this point in time because most of the clinics that we've gotten – or I would say, all of the clinics that we've gotten online, if you will, are clinics that we've interacted with quite extensively over the past couple of years, obviously in various settings. But that does not mean that it takes several years, obviously to put them online.

This is a very concentrated target audience, and we interact new business and have an ongoing dialogue. So – but it is a process that takes a while, because you need to get consensus within the center, and as I said, you need to take them through training and so on so forth.

So it doesn't happen from one month to the next, let me put it that way.

47:03 Okay. Great.

Thank you.

47:05 Thanks, Douglas.

47:26 Okay. In that case, thank you so much for your interest.

It's been a pleasure to update you on our progress so far and we look forward to continuing our dialogue. Thanks so much and have a nice day.