Hello everyone, and welcome to the Hansa Biopharma Interim Report for January to September 2022. My name is Daisy, and I'll be coordinating your call today. I would now like to hand over to your host, Søren Tulstrup, to begin. Søren, please go ahead.
Thank you, operator. Good afternoon, good morning, and welcome to the Hansa Biopharma conference call in the Q3 of 2022. I'm Søren Tulstrup, CEO of Hansa Biopharma. Joining me today is our CFO, Donato Spota, and Hansa's Head of Investor Relations, Klaus Sindahl. Today we'll discuss the progress we've made during the Q3 of 2022 and review our near-term milestones. The presentation should take roughly 50 minutes, after which there will be an opportunity to ask questions during a Q&A session. Please turn to slide two. Please allow me to draw your attention to the fact that we'll be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Now please turn to slide three and an overview of Q3 highlights.
Back in July, we executed a $70 million non-diluted financing transaction with NovaQuest Capital Management, strengthening our existing cash position to support the continued development of transformative drug candidates based on our unique antibody-cleaving enzyme technology platform and the commercial launch of Idefirix in Europe. With this cash injection from NovaQuest and our current cash on hand at the end of the Q3, Hansa's cash runway currently extends through 2024. On the operational side of things, our launch activities and market access efforts for Idefirix in Europe continue to progress as planned. A growing number of transplant clinics in countries where reimbursement has been granted are becoming clinically ready to use Idefirix and initiate therapy. In parallel with this, we are also gaining market access in additional countries.
Thus, during the Q3, we were pleased to obtain positive reimbursement decisions by payers in both Poland and Scotland as dialogues continue in other countries where HTA dossiers have been submitted. Total revenue for the Q3 amounted to SEK 67 million, including SEK 20 million in product sales. Donato will cover the financials in more detail later. As discussed in previous calls, it has been a priority of ours to work with the relevant European healthcare providers to put supranational guidelines in place for desensitization therapy. We're very pleased therefore to see the publication in the journal Transplant International of the first international guidelines for desensitization treatment of highly sensitized kidney transplant patients by the European Society for Organ Transplantation. We will cover these guidelines in more detail on the following slide.
In addition, I'm pleased that we could announce during the Q3 the first patient treated on a new European post-approval efficacy study of Idefirix in highly sensitized kidney transplant patients. This patient was treated in Barcelona, Spain, with a reported successful outcome. In the US, enrollment in our pivotal trial in kidney transplantation, the so-called ConfIdeS trial, is progressing according to plan, with 39 out of a target of 64 patients now enrolled across the US Randomization of all patients is expected to be completed in the first half of 2023, with BLA submission under the accelerated approval pathway anticipated in 2024. As for our AMR clinical development program, we look forward to the first data readout from our phase ll study later this year, following the completion of enrollment back in the spring of 2022.
With respect to our GBS phase ll program, patient enrollment is ongoing, and we currently have enrolled 20 out of a target of 30 patients in this trial. Further measures will be implemented to accelerate recruitment in the coming months, and we expect completion of enrollment in the second half of this year or first half of 2023. Last, I also want to highlight that Hansa was recently certified as a great place to work for the third consecutive year. This certification 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. Please turn to slide four. We're very pleased with the continued progress of our market access efforts. During the Q3, we secured positive reimbursement decisions in both Poland and Scotland for highly sensitized kidney transplantations.
The recommendation by the Scottish Medicines Consortium follows the recent positive recommendation from NICE for Idefirix in England, Wales, and Northern Ireland, expanding access for eligible patients across the UK. In Poland, we're also very pleased working with our partners at Medison Pharma to have reached an agreement with the Polish Ministry of Health. As a result of this agreement, Idefirix has now become the first and only product approved and reimbursed for the desensitization of highly sensitized patients in Poland. This decision to reimburse Idefirix follows last year's inclusion of Idefirix onto the list of technologies with a high level of innovation by the Polish Medical Fund. Market access has now been secured in nine European countries, including Germany, France, and the UK, while market access procedures continue to progress in eight additional countries, including Spain and Italy. Please turn to slide five.
In early August, the European Society for Organ Transplantation announced the release of the first set of guidelines targeting the management of highly sensitized kidney transplant patients. This phase l of the ESOT guidelines represents the first international consensus on a management pathway for highly sensitized patients and articulates the variability in definitions, approaches, and outcomes, as well as the perceived success of HLA-related transplantation. These guidelines provide a new clinical practice tool for healthcare professionals to help achieve the best possible outcomes for highly sensitized kidney patients, and are expected to be a key driver for harmonization in the approach to transplanting highly sensitized patients. An expert working group led by Professor Nizam Mamode, Professor of Transplant Surgery, previously at Guy's and St Thomas' Hospital in London, and other leading experts in the transplantation field, has been instrumental in driving this project.
The phase ll , which is now ongoing, will focus on the first experiences and patient outcomes as knowledge in practice with imlifidase growth within the transplant community. Please turn to slide 6 for a review of our ongoing clinical programs. As highlighted in the beginning of this call, we could recently report the first patient treated in our European post-approval efficacy study of Idefirix in highly sensitized kidney transplant patients. The patient, a 54-year-old Spanish man with chronic end-stage renal failure due to a malformation of the urinary tract, had required dialysis since 1984. After two unsuccessful transplantation attempts in 1991 and 1996, the patient's immune system became sensitized and his antibody levels were very high, making it impossible to find a compatible donor for all these years. In May 2022, the patient received imlifidase treatment followed by a kidney transplant.
After five months, the patient continues to be followed up on an outpatient basis and does not require dialysis. As for our AMR program, we look forward to announcing later this year the first data readout from our phase ll study in kidney transplant patients with active and chronic active antibody-mediated rejection episodes. AMR is a large indication with a high unmet medical need, with AMR episodes occurring in 5%-7% of patients post-kidney transplantation and with a significant risk of patients losing graft function. In highly sensitized patients, the frequency of AMR episodes is even higher, and there's currently no approved treatment for these rejection episodes.
The primary endpoint of the phase ll study is to investigate how effectively imlifidase therapy reduces the amount of donor-specific antibodies in comparison with plasma exchange therapy in patients who experience an active or chronic active antibody-mediated rejection episode after a recent kidney transplant. As secondary endpoints, DSA levels, kidney function, and graft survival will be measured up to 180 days after treatment. Based on the data from this study, we'll determine a path forward for imlifidase in the AMR indication. With respect to our GBS phase ll program, we've implemented several significant initiatives to increase enrollment rate as the trial has been impacted by the pandemic in various ways, including a shortage of IVIG, as well as reduced capacity and availability of staff across a number of trial centers.
We believe we'll see an acceleration in recruitment due to these initiatives, as well as additional measures that will be implemented in the coming months. Also, we expect high infection rates to be seen as we approach the winter season, leading to increasing incidence of GBS. Completion of enrollment in the GBS trial is anticipated in the second half of 2022 or first half of 2023, with first high-level data readout in the second half of 2023. In anti-GBM, we plan to commence a pivotal phase three study of imlifidase before year-end, as communicated earlier. The new global study will enroll 50 patients across sites in the US and Europe.
Last, in the US, our pivotal ConfIdeS trial in kidney transplantation is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the US Kidney Allocation System. Enrollment is progressing according to plan, with 39 out of a target of 64 patients now enrolled across the US Randomization of all patients is expected to be completed in the first half of 2023, with BLA submission under the Accelerated Approval Pathway in 2024. Please now turn to slide seven and a summary overview of our pipeline. As depicted on this slide, we have successfully developed a broad clinical pipeline in both transplantation and autoimmune diseases.
In addition, we have exciting preclinical projects ongoing in cancer and anti-drug antibodies, as well as in the very promising field of gene therapy, where preclinical studies with imlifidase led by our partners from Sarepta Therapeutics and AskBio are progressing as planned. Regarding Sarepta, we're pleased to observe the recent progress of the SRP-9001 program to treat ambulant patients with Duchenne muscular dystrophy, as Sarepta announced during Q3 that it had submitted a BLA to the US FDA under the Accelerated Approval pathway. This is indeed also a positive development for our collaboration with Sarepta, where imlifidase is being investigated preclinically as a potential pretreatment for inactivation of neutralizing antibodies ahead of Sarepta's gene therapy and where good progress has been made in the past period.
With this overview, I'll now hand over the call to Donato, who will take us through a review of the quarterly and half-year financials. Donato?
Thank you, Søren. Please turn to slide eight. In the Q3 of 2022, we have seen again very solid revenue with product sales amounting to SEK 23 million, revenue recognition under our agreements with Sarepta and AskBio increasing to SEK 44 million, and total revenue amounting to SEK 67 million. Overall, this is reflective of the continued good progress in market access expansion across our early launch markets and the progress with our partnerships within gene therapy. The Q3 increase in revenue recognition under our gene therapy partnership agreements is mainly driven by the AskBio collaboration, where Hansa has been having increased contributions in Q3. For the Q4, we do not assume the same level of increased contributions.
Looking at the September year-to-date performance, total revenue for the first nine months of 2022 amounted to SEK 124 million, of which SEK 66 million or 54% result from product sales, while SEK 55 million of revenue is recognized under the Sarepta and AskBio agreements, and SEK 2.4 million relate to the Axis-Shield license. Albeit still on low levels, this represents an almost seven-fold year-on-year increase in total revenue and a ten-fold year-on-year increase in product sales, again, confirming our commercial progress. Over the past nine months, we continued to make significant progress regarding pricing and reimbursement and broadening our hospital sales base across markets. However, we do still expect that sales remain volatile between quarters until we have established a foundation for repeat business at hospital levels through positive outcomes in the first patients now treated.
Please turn to slide nine. For the first nine months of 2022, SG&A expenses amounted to SEK 254 million, compared to SEK 225 million for the same period last year. In the Q3, SG&A expenses amounted to SEK 83 million, which continues to be roughly on par with the levels seen during the previous quarters. R&D expenses amounted to SEK 254 million for the first nine months of 2022, compared to SEK 163 million for the same period last year. For the Q3, R&D expenses amounted to SEK 91 million, compared to SEK 61 million for the same quarter last year. The increase in R&D is mainly driven by the ongoing ConfIdeS study in the US, our post-approval study in Europe, and the preparations for our pivotal phase 3 program in anti-GBM disease.
Further, we have also increased our investments in our second-generation NiceR program as we move the lead candidate closer to a potential first clinical study next year. As discussed at previous earnings calls, investments in R&D and our pipeline activities across all four franchises remain a high priority as it underpins the company's long-term value creation strategy. Net loss amounted to SEK 463 million for the first nine months of 2022, and SEK 154 million for the Q3. The increase over last year primarily reflects our increased R&D investments, partly offset by increased sales and revenue. Please turn to slide one0. Cash flow from operating activities amounted to SEK -129 million for the Q3 of 2022, which compares to SEK -132 million for the same period in 2021.
For the first nine months of 2022, operating cash flow was -SEK 393 million compared to -SEK 365 million for the first nine months of last year. Hansa's cash position at the end of September was SEK 1.2 billion, including the proceeds from our structured debt financing with Norwest as alluded to by Søren earlier. We expect that this will finance our operations through 2024. I'm now handing back to Søren for his final remarks.
Thank you, Donato. Now please turn to slide 11. As discussed, we continue to demonstrate solid progress across our business operations and clinical program activities as we build and advance a pipeline of valuable drug candidates for rare immunologic diseases. During the first nine months of 2022, we achieved solid revenue growth despite an overall challenging market, including continued negative impact from the pandemic, increased geopolitical uncertainties, and inflation. Looking at the milestones for the remainder of the year and the years to come, we're very encouraged by the demonstrated potential of our unique antibody-cleaving enzyme platform as we continue our journey towards becoming a global leader in rare immunologic diseases. As discussed, we anticipate communicating a first high-level data readout from our phase ll study in AMR before year-end. The data from this study will inform our decision-making regarding the path forward in the post-transplantation setting.
In anti-GBM, we anticipate commencing this year as well a new pivotal phase lll study of imlifidase in 50 patients across the US and Europe. As far as NiceR is concerned, our next-generation enzyme program for repeat dosing scenarios, we expect IND-enabling tox studies to be completed towards the end of this year, with the potential to move this program into the clinic early in 2023. In our US ConfIdeS study, we expect to complete enrollment by year-end, as previously communicated, while randomization of all patients is aimed for completion in the first half of 2023, with a BLA submission under the accelerated approval pathway in 2024.
In GBS, we expect to see an acceleration in enrollment of patients due to a number of initiatives we have implemented, as well as higher infection rates as we approach the winter season, and we expect enrollment to be completed in the second half of this year or first half of next year. Please turn to slide 12. This concludes our presentation, and we would now like to open the call for questions. Operator, please begin.
Thank you very much . Our first question is from Christopher from SEB. Christopher, your line is open. Please go ahead.
Thanks very much for taking my questions. I had a couple on the clinical program and then one on the gross margin. I noticed you listed a live donor trial, which seems really exciting. Can you give us a little bit of details about. I'm just thinking about what extent, 'cause it's 12 patients and an academic center running it at the moment. To what extent is this adaptable or, you know, what opportunities are there to leverage it in your R&D program? That's the 1st question.
What we have is we're looking at, you know, rebound of donor-specific antibodies, you know, essentially, which is a small trial that we're running. If you look at the broader opportunity to expand the label to also include living donor scenarios, obviously there's quite some potential in that indication. You wouldn't have. This would actually add, of course, organs and donors to the pool, and therefore it's market expansion very much. It's certainly something that we'll be pursuing at some point. The path forward to getting this into the label has not been determined at this point in time.
Right. Okay. And then for AMR, obviously you have a readout coming up pretty soon. I just wanted to hear what your take is on how good PLEX is in this population in terms of lowering DSA. If you can talk about the sort of the extent to which there is an overlap between you know highly sensitized and and the AMR populations in terms of DSA levels, inflammatory response. I mean, just trying to gauge you know obviously a complex issue, but to what extent is there a cross-read between success in desensitization and and AMR?
Yeah. If we look at the way PLEX works versus the way imlifidase works and the results in terms of lowering donor-specific antibodies, you would expect to see a faster and more complete reduction in general in patients undergoing imlifidase therapy compared to PLEX therapy. PLEX is part of the standard of care currently. If you look at it overall, standard of care is something that can manage the majority of patients, but there's clearly a number of patients where you need efficacy faster and above, you know, what you can get with standard of care.
Clearly there is a high unmet medical needs and you know, in our discussions also with key opinion leaders and clinics, that is something that is clearly recognized. Then you asked about the overlap between highly sensitized patients and AMR. In you know, AMR affects approximately you know, 5%-7% or so of all kidney transplanted patients, and the majority of these events happen you know, in the first six months. There is a higher incidence in patients who are highly sensitized. Highly sensitized patients represent a larger proportion of these patients than less sensitized, moderately sensitized patients.
Again, given this, we do expect that, you know, certainly we hope that we'll have, you know, benefit in the imlifidase arm versus the PLEX arm as far as the primary endpoint is concerned.
Thanks. Just coming back to the PLEX, you know, to what extent has it been quantified? I mean, the amount of DSA reduction, to what extent has it been quantified, and what's the consistency like across studies that have done that?
Well, there is quite some variability there and really depends on the specific, again, centers and specific you know circumstances. I can't give you any specific number, but certainly this is something that has been studied and been part of considerations prior to you know designing and initiating this study.
Okay. Thanks. Lastly, on the gross margin. Does the COGS for the quarter include Idefirix used in trials? I guess, you know, just kind of trying to get why it's at the level that it's at, and when do you start enjoying scale?
I'll hand over to Donato for this. If you look at the margin in general, obviously it has to do also with the production of batches, right? Where there's quite some variability there. Donato, can you take this?
Yeah. Yeah, absolutely. To the first part of your question, Christopher, no, the cost of goods do not include material that are used in clinical studies. That's not how the accounting is running. The reason why you can see a gross margin, which is actually pretty variable across the quarters, if you look on quarter-by-quarter basis and maybe appears a bit higher is as indeed as you know, Søren Tulstrup is alluding to. When we are manufacturing batches, we are obviously manufacturing those batches on a commercial scale that takes into account where we wanna be in a few years from now.
Obviously this is relative to the sales that we're seeing right now, this is obviously you know more costly than where it's going to be when we are more on a you know reached kind of peak sales levels or close to the peak sales level. This is really an effect that is hitting the P&L now during the launch phase, but will even out going forward. That's not representative of what the cost of goods are going to be in a few years from now.
Okay, thanks so much.
Thanks, Christopher.
Thank you. Our next question is from Adam Karlsson from ABG. Adam, your line is open. Please go ahead.
Hi. Thanks for taking my questions. A couple on AMR as well, if I could. Kind of building on a previous question. In terms of the level of antibody reduction you'd expect to see in AMR patients using imlifidase. Is there any reason sort of mechanistically or other why this would be sort of materially different from the level antibody reduction we've seen already in the approved indication and then in desensitization? Yeah, I think maybe that's the best way to put it. Yeah. That's the 1st question.
Yeah. Thanks. Thanks, Adam. The answer is no, essentially. We would expect to see the same level of reduction and the same pattern, if you will, in terms of, you know, how fast the reduction takes place, as we've seen in highly sensitized patients, you know, being ready for a kidney transplant.
Okay. Great. Thanks. And then on the study itself, it's a small study, obviously, 30 patients. A lot of potential noise from confounding factors as you were alluding to. Are we realistically looking at sort of from a statistical point of view, sort of non-inferior results, perhaps with a trend towards superiority or was the study powered to show statistical significance? If so, could I draw you to comment on your estimate for the power calculation? What differences were you hoping to see and at what level of power?
Yeah. I'm not gonna comment on the last part of your question there. Yes, I mean, it is obviously we do expect and hope to see superiority as far as the primary endpoint is concerned, which is really around how much donor-specific antibodies are reduced and how fast, right? It's around what happens in the first five days. Then we have a number of secondary endpoints looking at 180 days that includes donor-specific antibodies, but also quite a number of endpoints you know related to graft function. That's essentially the setup, right? You initially look at donor-specific antibodies immediately after therapy. Then there's this 180-day follow-up.
Okay. No, great. Previously, you've said that there might be potentially, depending on, I guess, the strength of the data, the possibility to take that to regulators and see if it would be sufficient for filing. Now that we're getting closer to that readout, are you able to offer any more, you know, specifics on what you'd need to see or sort of, qualitatively anyway, what might make you feel confident enough to discuss that with regulators?
I mean, obviously, you would have to see what the response of regulators is. But I would say that it would be expected that we would have to run a larger, longer-term trial to get this into the label. I think this is. If you look at the field, this is what has happened in the past. It has been quite challenging to run these larger and long-term studies in AMR. Currently there is essentially no approved therapy, right? There is standard of care, and that's what's there.
What we're currently, you know, focused on is really generating encouraging data so that this can kind of be part of the information package available to, you know, clinicians in the field as a, you know, plan for therapy. Clearly, based on the dialogues that we're going to have with regulatory authorities based on the first set of data here from this phase ll trial, we'll determine what the path forward is, you know, what a potential phase three trial would look like and so on. That's, I hope, a response to your question there.
No. That's very helpful. Thank you. Maybe a brief final question then on... I mean, we're getting towards the end of 2022. Headcount, as you were showing, stable and operating costs fairly stable quarter-over-quarter now. Could you comment on sort of what we should be thinking at perhaps high level on the trajectory of SG&A and R&D costs, looking into, say, 2023?
I'll hand over to Donato to have him chime in here on this. Overall, I mean, we are building up the organization, but you're not gonna see a massive expansion. There will be some, you know, continued build-up of the organization. Then as far as R&D costs are concerned, obviously, you know, we have the Confidase trial. We have the anti-GBM trial getting ready to fly. GDS is ongoing as well. We might initiate at some point additional trials. You know, we do not expect a significant increase in R&D costs. Over to you, Donato.
Yeah. I think you've given the answer. I think we would be expecting a somewhat of an increase on the run rate versus Q3 this year. really, as Søren mentioned, I mean, really something which is very much under control. Obviously there's two aspects which is a bit difficult to estimate. One is inflation, the other one is the FX impact. generally speaking, we're not. Let's say we're planning to gradually invest in the commercial space still.
On the R&D side, we will have obviously, I think the most important impact is going to come from the phase 3 anti-GBM, which will add a certain level, of course, on top of where we are today.
Great. That's very helpful. Thank you.
Thanks, Adam.
Thank you. Our next question is from Douglas Tsao from H.C. Wainwright. Douglas, your line is open. Please go ahead.
Good morning, thanks for taking the questions and congrats on the progress. I'm just curious in terms of what's the day-to-day commercial performance. We started to see sort of a lot nicer consistency in terms of, you know, several patients being treated each quarter. I'm just curious as to where we're starting to see increased activity or what's really driving it right now. Is it that we're starting to see, you know, consistent patient flow in the original countries, or has this been a function of sort of gaining reimbursement in some new markets? Thank you.
Well, I mean, overall it is a combination, you know. Clearly what we're seeing right now is, you know, in France, for instance, there's been a good ramp-up in terms of your early access program. There's strong interest from quite a number of centers. So they're quite far advanced in terms of identifying patients and so on. That we're seeing good development there. In the UK, it's still early days after the agreement with NICE and dialogues with the National Health Service. There's quite a number of clinics there that are having internal discussions as to, you know, kind of the structure, who should be involved and so on, the specific approach.
We have yet to see kind of an impact from the UK, but we expect that to be coming in the coming months. We have, of course, Germany, where we've had now reimbursement and overall market access, and where again, we're seeing overall lots of interest and activity in terms of identifying patients. What is always difficult to, again, predict, as we've discussed in the past, is how long it's gonna take for these patients that have been identified, put on a list in a specific center that is clinically ready and commercially ready to initiate therapy, how long it's gonna take to find an organ that will be offered to this patient, right? But it's good to see progress in Germany as well.
We have, you know, as we've discussed, we've seen activity in the Netherlands and, you know, we had this from the post-approval efficacy study, this patient and we have a couple now. One patient from Spain has been reported. We are seeing kind of broad, you know, activities across Europe, primarily of course, in those countries where we have access at this point in time.
Okay. Great. Søren, is it taking roughly the same amount of time to ramp up in these new markets and new centers as it did in the original countries that you were in, or are you able to shorten that cycle? Thank you.
Yeah. I would say that it takes, you know, more or less the same time. There's obviously kind of inter-clinic variability here. In general, I mean, they have to go through a number of steps, right? One of the most complex really is after a patient has been identified, to make sure that there's delisting of antigens so that there is a sufficient flow of organs to the center and to the specific patient so that, you know, there's a chance that a specific organ will be offered to that patient who's top of the list. In general, I would say, yes, it does require some time from being clinically ready to actually, you know, having a patient transplanted.
Okay, great. Thank you.
Thanks, Douglas.
Thank you. Our next question is from Zoe Karamanoli from RBC Capital Markets. Zoe, your line is open. Please go ahead.
Hi. Thank you for taking my questions. The first question is with regards to the Sarepta and AskBio revenue recognition. Can you provide some details as to what it relates to and the progress in the preclinical setting? Are you still expecting entry into phase l for the Sarepta collaboration in the first half of next year? That's the 1st question.
Thanks. I'll hand over to Donato for the specifics around the revenue recognition, but just let me address the Sarepta question overall. What we have been doing so far is preclinical work. As I reported earlier during this call, you know, we've seen good progress here, real team effort. The next step, hopefully in the near future, would be for Sarepta to make a decision, you know, as to whether they would take it into the clinic, and that could happen, you know, in the not too distant future, as I said. Then, as far as the revenue recognition is concerned, Donato, I'll hand over to you.
Sure. Hi, Zoe. You know, under the accounting rules, the contributions that a company makes into a collaboration drives obviously the recognition of the revenue then into the P&L. Under the AskBio agreement, I mean, our contribution is basically dominated by the providing imlifidase product and other materials on top of our know-how. The dominating factor in terms of overall value, because that's a much shorter, obviously, as you know, a much shorter agreement. It's a focus on feasibility at this point. The imlifidase product and other material delivery is kind of the dominating factor here, and that drives revenue recognition. It's much more an on-off approach than we have on the Sarepta, where our resource contribution and know-how contribution is actually the driving factor, which makes it a much more stable quarter-over-quarter recognition, if that makes sense.
Yeah. Yeah, it does. Okay. That's great. Thank you. The next question is around recruitment and randomization for the Confidase trial. Given the complexity at randomizing patients, and availability of a suitable kidney organ, how should we be thinking the ramp up in the US once imlifidase will be launched? Will a slow ramp up there as well be a sensible approach? Just interested in your thoughts here.
Yeah. Thanks, Zoe. You're right. Obviously, there are complexities around making sure that there is a consistent and an adequate flow of organs to the clinics participating in the Confidase trial. That's a little bit of an art. You know, they have to, as you said earlier, look at how they can delist antigens to make sure that these highly sensitized patients are still getting organs offered. We see that is happening with some delay after, you know, the involvement of the patients. It's a question of months. What is good is that, you know, during this trial, through this trial, the centers, which are some of the leading centers across the US, they're gaining very valuable experience in doing this, right?
When we're ready to launch, hopefully in the US in some years, there will be this very valuable experience in the key centers in the US. We do expect a faster ramp up in the US compared to Europe just because of this, but also, of course, because of the fact that in general, you see faster ramp up of, you know, transformative drugs, very innovative drugs in the US compared to Europe. At this point in time, we have 10 centers actively involved in the study, and we expect to expand that to 15 or maybe even more. The 10 centers that we currently have, I mean, they represent 10% or so of the annual kidney transplant volume.
Really very important centers, and we're very encouraged by the interest shown by the heads and all the staff involved in these centers.
Okay. That's great. Thank you.
Thanks, Zoe.
Thank you. Our next question is from Luisa Morgado from Kempen. Luisa, your line is open. Please go ahead.
Hi, yeah. From Jacob from Kempen. Thank you for taking my questions. I wanted to first ask what do you expect in terms of Idefirix sales to be like in the last quarter of this year? Also a second question, when do you expect to complete the post-authorization study?
Thanks for those questions, Luisa. We are not providing any guidance for sales in general and certainly not by quarter. What we have said is that you should expect quarterly sales to be quite volatile, you know, from quarter to quarter because this is not, again, this is not a chronic therapy, right? Where you have certain number of patients, and then you have new patients, and you have patients that are flowing out, and then, you know, you have a certain base that is growing with a certain cadence. Here you have, you know, one-off therapy in very limited number of patients with a product that has a very high price tag, optimal price tag. It will be volatile from quarter to quarter.
What has been very encouraging is to see actually over the past few quarters, the consistency, right? That there seems to be now quite a consistent pattern. We would expect over the next quarters again to see quite some volatility. As I said initially, we're not providing any sales guidance at this point in time because we would know. I mean, that would be wrong. The 2nd question you asked was. Can you just repeat the second question?
Sure. When do you expect to complete the post-authorization study?
Oh, yeah. I mean, we have to complete it by the end of 2025. There is no urgency here. We have reported the first patient, you know, in this study. We currently have a couple. We need to enroll, you know, 50 patients, and so there is a number of years to do this. As we've discussed in past calls, this is a great way not just to generate data, but also to, of course, make sure that the centers get experience with imlifidase. There is no urgency from our point of view, other than that we need to, as I said, complete the trial by the end of 2025.
Thank you. Just one more question. Could you maybe provide some guidance on when in 2024 do you expect your cash runway to go to?
In what year? Sorry.
You said that your cash runway-
The cash runway, we've said, you know, takes us through 2024.
Do you know maybe more specifically?
No. Unfortunately, we're not guiding.
Thank you.
More specifically. I mean, there are so many factors that depend, you know, this depends on. I think overall, we believe, according to current plans that, yeah, through 2024, we'll have a cash runway with the existing cash.
Okay. Thank you very much.
Thanks, Luisa.
Thank you. Our next question is from Johan Unnerus from Redeye. Johan, your line is open. Please go ahead.
Thank you for taking my questions, and also thank you for some good questions earlier. Basically, more or less some follow-up. 1st, on the AMR setting, could you remind us and give us a flavor of what to expect in the current standard of care in terms of the success rate or the ability to save these episodes when they start to happen, so to speak?
Well, if you look at hard endpoints in terms of, you know, graft survival and graft function and so on, in general, I mean, standard of care, it has a relatively good track record in terms of managing these episodes. Still, there's quite a number of patients that end up losing their grafts, right, and have, you know, damage and so on, that will impact the durability and life extension of the graft. There's clearly, as I said, an unmet medical need in this field.
Is this also related to the level of sensitization among the patients? Is it sort of a more problematic graft survival among more highly sensitized patients?
Yeah. What you see is, as I said, you know, in general, 5%-7% of all kidney transplanted patients have these episodes, sometimes more than one. If you look at the highly sensitized patients, there it's reported, you know, as high as 45%. What we've seen in our long-term follow-up study from phase ll so far is also, you know, 38%, if I recall correctly, of our patients had these episodes of AMR. Again, they're in general manageable using standard of care, but there are still a number of patients that lose their grafts.
Is that proportion also higher among highly sensitized patients?
Yes. Well, if you look at our own data, no, that's not the case. In general, as I said, there are more highly sensitized patients that have these episodes. I cannot say that highly sensitized patients suffering these episodes have a higher graft loss incidence than other patients. I certainly haven't seen those data.
Okay. There is probably some level of transparency in terms of how to say extra contribution from collaboration. There is a run rate of some SEK 4-5 million, but this quarter it was more, obviously. You alluded to that there could be expected some activity over the next 6-12 months. Could you give us a little bit more flavor of what to expect on that side?
I mean, what we've reported, you know, as far as the Sarepta collaboration is concerned, is that we're eligible for milestone payments up to, you know, just shy of $400 million, and we've not specified kind of the specific milestones or communicated any expectations around the timing and so on. As far as AskBio is concerned, you know, this is a different collaboration agreement in that it's a feasibility-focused collaboration, both the clinical feasibility studies will be implemented. We have then qualified for a $5 million upfront that was paid, of course. Then we're just recognizing this based on, as Donato talked to, specific activities.
The Sarepta collaboration, you know, we have not been more granular than just the total amounts. Donato, do you wanna add anything to this?
Yeah. I think one thing that we have been saying in the past is obviously that, you know, it's rather backloaded in order not to burden the R&D phase.
Yeah.
There is a more significant amount coming in terms of regulatory milestones, so from filing and potential approval, and then obviously commercial milestones, sales milestones.
Yes. I guess that's what you should expect, especially if you were sitting on the other side of the table, I suppose. Thank you very much.
Sure. Thanks, Johan.
Thanks, Johan.
Thank you. Before I take our next question, I'd just like to remind everyone, if you would like to register a question, please press Star followed by one on your telephone keypad. Our next question is from Dominic Rose from Intron Health. Dominic, your line is open. Please go ahead.
Hi, this is Dominic from Intron Health. Thanks for taking my questions. I've got three. The first question is on Medison Pharma. Can you give us an update on when we can expect to see the first revenues from that collaboration?
Sorry, I didn't hear your question very well. Can you repeat that?
Me neither. Sorry. I was asking on Medison Pharma, can you give us an update on when we can expect to see the first revenues from that collaboration?
The medicine collaboration or agreement is focused on Israel and certain East European countries. You know, we have now secured reimbursement in Poland. We obviously need to see that implemented, but it is clearly a priority area for the system in Poland. As I talk to, I cannot give any specifics around when we expect you know revenue to be coming there, but it could come in the near future. Then we have the product approved in Israel. Again, I can't be specific here, but it wouldn't necessarily take a long time, but I can't be very specific on this.
Okay, thanks. On the ESOT guideline, I was hoping to get an idea of how important you think these could be in terms of driving European sales, and also whether you think that indeed it could become the recommended desensitization option in the second phase of the guideline.
Well, we certainly think that they're quite important for, let's say the long-term commercial opportunity, right? To have these supranational European-wide guidelines in place, and certainly if they are quite specific as to the place of imlifidase and they recommend use of imlifidase, that will be very helpful. Phase l here has been helpful in that it has engaged the key opinion leaders and the key clinical heads and academics across Europe that they have recognized that highly sensitized patients really, you know, have a clear problem and that the medical community needs to do something about it, and that there is now, you know, one additional option, namely, imlifidase.
That's really helpful in increasing the awareness across Europe, and it has certainly been very helpful to see this task force also engage, you know, internally with other clinics and ourselves, quite frankly. We would certainly hope that based on positive experiences with Idefirix, and as you know, several of the very early transplants having taken place post the approval and also post gaining market access have been positive, that this would lead to a, you know, benign wording around the place of Idefirix in therapy. We do think, as I said, yes, they will have a clear positive impact, hopefully, but more long-term or medium to long-term.
Even short-term, it's certainly helpful in increasing the awareness around the problem and the fact that the medical community needs to do something about it.
Okay. Many thanks. Finally, to go back to the AMR readout, could you talk us through what options you think you'll have for this program once the readout's positive? Also thinking about whether there's the funding in place for a phase lll. Thanks.
Yeah, I mean, so clearly one option, again, with good data, hopefully, would be to, again, agree with the regulatory authorities on the path forward towards getting this in the label. That would, you know, as I discussed earlier, likely include having to run a phase three trial. We've seen in the past that they tend to be quite large and have long duration. And all of this is something we need to consider, you know, how would we, in this scenario, best be able to get it into the label.
Also we're certainly, as I said, looking to get positive data that can be published, so that it's in the public domain, because this will inform, you know, decision-making and thinking around how these patients are treated, in general. I hope that this helps.
Yeah. Thank you.
Thanks, Dominic.
Thank you. We have no further questions, so I'll hand back over to the management team for any closing remarks.
Thanks so much, operator, and thank you, everyone, for your interest in today's call. As I hope you'll have seen, you know, this has been another solid quarter. We've seen solid progress in our launch activities and also clinical development programs. Looking ahead, we have some important milestones coming up. We've discussed the AMR readouts. Next year, we'll also have the GBS readouts. We are getting ready to put NiceR into the clinic, hopefully in the first half of next year. We have some important decision-making by our partner in the gene therapy space, Sarepta, as well as hopefully seeing progress with the AskBio collaboration also in the gene therapy space.
Exciting times, and I look forward, we all look forward to keeping you updated on coming progress. Thanks so much.