Hello all, and a warm welcome to the Hansa Biopharma second quarter 2022 business update. My name is Lydia, and I'll be your operator today. If you'd like to ask a question at the end of the presentation, you may do so by pressing star followed by the number one on your telephone keypad. Please limit your questions to a maximum of three, and return to the queue if there are any further questions that you may still have. It's my pleasure to now hand you over to our host, Søren Tulstrup, President and CEO of Hansa Biopharma. Please go ahead when you're ready.
Thank you, operator. Good afternoon, good morning, and welcome to the Hansa Biopharma conference call on the second quarter, 2022. I'm Søren Tulstrup, CEO of Hansa Biopharma. Joining me today is our CFO, Donato Spota, and Head of Investor Relations, Klaus Sindahl. Today, we'll discuss the progress we made during the second quarter of 2022 and review our near-term milestones. After the presentation, there will be an opportunity to ask questions during the Q&A session. Now please turn to slide two. Please allow me to draw your attention to the fact that I'll be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Please turn to slide three. Hansa's commercial launch activities and market access efforts for Idefirix in Europe continue to progress as planned.
During the second quarter of 2022, we continued to see solid sales development as clinics are getting clinically ready and patients are identified for treatment at leading centers across European markets. Additionally, last month, we're very pleased to announce that Idefirix had become the first and only product recommended by NICE for the desensitization of highly sensitized patients waiting for a kidney transplant from a deceased donor in England, Wales, and Northern Ireland. This positive NICE recommendation represents an important step forward for Hansa's commercialization efforts and for patients in the U.K. who've been struggling to find a matching donor and, in most cases, have had no other alternative but to remain on long-term dialysis. Following the NICE recommendations, market access has now been secured in seven countries to date, with additional 11 market access procedures ongoing throughout Europe.
On the clinical development side, we're equally pleased with the advancements we've made during the first half of the year. I'm particularly excited about the on-time completion of enrollment in our phase II program in AMR, which marks an important milestone for Hansa as we explore the potential of imlifidase in the post-transplantation setting. Active and chronic active AMR episodes cause significant risk for kidney transplant patients of losing their graft function and ending up in long-term dialysis. In addition, there is no approved treatment today for patients suffering from rejection episodes. As previously communicated, we expect the first data readout in the second half of 2022. In anti-GBM antibody disease, we're preparing to commence a new global pivotal phase III trial in 50 patients this fall. We're very excited to start this pivotal trial in a serious autoimmune disease with high unmet medical need.
As you may recall from our last call, the enrollment rate in our phase II program in Guillain-Barré syndrome had seen a slowdown during the winter season due to the direct and indirect impact from the corona pandemic. Since then, we've implemented several initiatives to improve the enrollment rate, and during the second quarter, we started to see a pickup in recruitment rate. Assuming the current COVID situation does not escalate further, we should see another step up in the enrollment rate during the second half of the year. Turning to the U.S., where our pivotal phase III program in kidney transplantation, also known as the ConfIdeS study, is also progressing. As of today, 22 patients have been enrolled out of a target of 64. We'll discuss our clinical development programs in more detail later in this presentation.
Lastly, I'm also pleased by the appointment of Peter Nicklin as new Chairman of the Board of Directors at Hansa Biopharma. Peter brings significant global experience from both non-executive and senior executive roles within the life science industry at companies such as Baxter, Bi Healthcare, Novartis, and Bristol Myers Squibb, and currently serves as Chairman of the Board of several life science companies. Post our closing period, we've disclosed two major events, which we'll also address further in this presentation. First, on July 11th, we announced that the first patient was treated with imlifidase in our mandatory post-approval efficacy study in kidney transplant in Europe. 50 highly sensitized patients incompatible to a deceased donor are expected to be treated with imlifidase during this trial.
Second, on July 18th, we could also announce a $70 million product finance transaction with NovaQuest, which will extend our expected cash runway through 2024. We're very pleased to have secured this funding, which will be deployed to support the continued development of our unique antibody-cleaving enzyme technology platform across multiple therapeutic areas. Donato will cover the transaction in more detail later during this presentation. Now please turn to slide four. As highlighted moments ago, we continue to see solid progress with our Idefirix commercial launch activities and market access efforts in Europe. During the second quarter of 2022, we achieved an important milestone when Idefirix became the first and only product to be recommended by NICE for desensitization of highly sensitized patients waiting for a kidney transplant from a deceased donor in the UK.
In addition to this recommendation, NICE also highlighted Idefirix as both a clinically and cost-effective treatment, which is rare for orphan drugs. This recommendation is an important step forward for Hansa's commercialization efforts and for patients in the U.K. region who've been struggling to find a donor match and, in most cases, has had no other alternative but to remain on long-term dialysis. We're also pleased that Idefirix was graded ASMR 3 rating by the Transparency Committee of the French National Authority for Health, which came in the wake of qualifying for the AP2 early access program, which was granted in the beginning of the year. Less than 6% of all new medicines in France are granted an SMR free rating, which is another testament to the medical benefit that Idefirix brings to patients and society as a new transformative therapy.
Last, we are also pleased that the Swiss agency for therapeutic products, Swissmedic, granted temporary marketing authorization in Switzerland for Idefirix and kidney transplantation, which comes on top of the already received marketing authorizations in the EU, the U.K., and Israel. We currently have market access procedures ongoing in 11 countries, including Spain and Italy, and expect to close additional agreements during the remainder of the year. Please turn to slide five. A week ago, we announced the first patient treated in our new European post-approval efficacy study of Idefirix in highly sensitized kidney transplant patients. This post-approval study, which is a mandatory requirement under the European conditional marketing authorization for Idefirix, will be a global label phase III study in 50 highly sensitized patients who've undergone kidney transplantation after treatment with Idefirix.
Patients will be enrolled across multiple countries and centers in Europe, with the aim of investigating long-term graft survival by determining the one-year graft failure-free survival of the Idefirix-treated and transplanted patients. As a non-comparative concurrent reference cohort with no formal comparison, a total of 50 to 100 patients undergoing compatible kidney transplantation at the participating centers will be included to contextualize the one-year graft failure-free survival of the Idefirix-treated patients. Now please turn to slide six and a review of our ongoing clinical programs. As briefly mentioned in the beginning of the call, we announced in May the on-time completion of enrollment into our AMR phase II program. A total of 30 patients with active or chronic active AMR episodes post-kidney transplantation have been enrolled across 14 centers in Europe, Australia, and the U.S.
Acute AMR episodes post-kidney transplantation occur in 5%-7% of transplanted patients, and the risk of patients losing graft function is even significantly higher for sensitized and highly sensitized patients. There is currently no approved treatment for AMR, and the completion of enrollment marks an important milestone for Hansa as we explore the potential of imlifidase in the post-transplantation setting. As previously noted, we expect the first data readout in the second half of 2022. Regarding our GBS program, we've discussed earlier this year the impact that the COVID-19 pandemic and the emergence of the new variants have had on the enrollment rate, both directly and indirectly. To mitigate this situation, we implemented several initiatives during Q2, including simplifying the protocol, adding new centers, and helping fund staff for the after-hours.
Assuming the COVID situation does not escalate any further, we expect these initiatives will help boost enrollment even further, with the aim of completing enrollment by the year. In anti-GBM, we expect to commence a pivotal phase III study of imlifidase following FDA's acceptance of Hansa's investigational new drug application earlier this year. The new study is expected to enroll approximately 50 patients across the EU and U.S., with the first patient expected to be enrolled later this year as previously guided. In the U.S., our pivotal ConfIdeS trial in kidney transplantation is progressing, with 22 out of a targeted 64 patients now enrolled for randomization. The ConfIdeS study is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system.
We've initiated enrollment at 10 sites and expect participation by up to 15 leading transplantation centers across the U.S. Enrollment is expected to be completed by the end of this year, as previously guided. Results from the trial are expected to support a BLA submission under the accelerated approval pathway in the first half of 2024. Now please turn to slide seven 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 exciting pre-clinical projects ongoing in cancer and anti-drug antibodies, as well as in the very promising field of gene therapy, where pre-clinical studies with imlifidase led by our partners from Sarepta Therapeutics and AskBio are progressing as planned.
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 first half of 2022, we started to see a strong impact on revenues as a result of the commercial launch activities carried out over the past 12-18 months in our early launch markets. Total revenue for the first six months of 2022 amounted to SEK 57 million, including SEK 44 million in product sales and SEK 11 million of revenue recognized under the Sarepta agreement. In Q2 2022, product sales contributed SEK 19.5 million to our total revenue. Although it is still at a low level, this progress reflects continued solid quarter-on-quarter sales. We are still in an early launch phase though. We do expect that sales will remain volatile and continue to fluctuate on a quarter-on-quarter basis. Please turn to slide nine.
For the first half of 2022, SG&A expenses amounted to SEK 171 million, compared to SEK 141 million for the same period last year. Q2 2022 SG&A expenses amounted to SEK 90 million and are in line with the average quarter-on-quarter spend over the past four quarters. R&D expenses amounted to SEK 164 million for the first half of 2022, compared to SEK 102 million for the first half of 2021, with SEK 93 million in R&D spend in Q2 2022.
The step up in R&D is mainly driven by the initiation of our ConfIdeS study in the U.S., the start of the post-approval study in Europe, the preparation for the pivotal phase III program in anti-GBM disease, as well as a catch-up in expenses related to our ongoing phase II programs in GBS and AMR, which were temporarily paused due to COVID in 2021. Investment in R&D and our pipeline activities across all our four franchises remain a key priority as it underpins the company's long-term value creation strategy. The net loss ended at SEK 309 million for the first half and SEK 170 million for the second quarter, which reflects the increased spending level in both SG&A and R&D compared to last year. Please turn to slide 10.
Cash flow from operating activities amounted to -SEK 136 million for the second quarter of 2022, which compares to -SEK 113 million for the same period in 2021. Overall, our quarterly cash consumption has approximately stabilized over the past four quarters. Hansa's cash position, including short-term investments, amounted to SEK 617 million end of June. Post our recent financing transaction, which we'll cover on the next slide, our cash position increased to approximately SEK 1.3 billion, corresponding to approximately $130 million. Please turn to slide 11. As mentioned, we just announced a $70 million product financing transaction with NovaQuest to support the continued development of our antibody-cleaving enzyme technology platform across multiple therapeutic areas.
This transaction will extend our expected cash runway through 2024 and help us to further strengthen our position in kidney transplantation through the continued support of the European commercial launch of Idefirix, and starting the preparations for a potential launch in the U.S. Further, we now also have the resources to fully fund our U.S. ConfIdeS trial, as well as our global phase III development program in anti-GBM, which is expected to commence later this year. Together with our existing cash, also complete our ongoing phase II programs in GBS and in AMR, as well as to advance our next generation of enzymes, the NiceR program, into clinical development. Under the terms of the agreement, NovaQuest will provide Hansa with $70 million within the next three weeks from the execution of the agreement.
In return, Hansa will now make quarterly mid-single-digit royalty payments to NovaQuest for future worldwide annual net sales of Idefirix, commencing upon approval by the FDA of Idefirix in either kidney transplantation or in anti-GBM. In addition, Hansa will make certain milestone payments to NovaQuest upon FDA approval of Idefirix in kidney transplantation and in anti-GBM. Total payments by Hansa to NovaQuest will be capped at $140 million. The agreement also provides for time-based catch-up payments within the payment cap if specific payment amounts have not been received by NovaQuest by specified dates, with the last potential catch-up payment due on December 31, 2028. Hansa and NovaQuest have also entered into a security agreement to provide NovaQuest with collateral to certain of Hansa's assets and IP. Importantly to note that there are no financial covenants.
I now hand back to Søren for his final remarks.
Thank you, Donato. Now please turn to slide 12. Hansa's business operations and development programs continue to advance as planned despite an overall challenging environment. We've demonstrated solid progress in executing our key strategic priorities, including ensuring a successful launch of Idefirix in Europe and solid sales development so far in 2022. In parallel, we are also advancing our pipeline of valuable drug candidates for rare immunologic diseases while we continue to see good progress with our partnerships as well. Looking at the milestones for the remainder of the year and the years to come, we're very encouraged by the potential of our unique antibody-cleaving enzyme platform as we continue our journey towards becoming a global leader in rare immunologic diseases. As highlighted earlier, we expect to commence a pivotal phase III study for imlifidase and anti-GBM following FDA's acceptance of our IND application earlier this year.
The new global study is expected to enroll approximately 50 patients across at least 25 centers in the E.U. and U.S., with the first patient expected to be enrolled later this year as previously guided. 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 the year, with the potential to move into the clinic early in 2023. In the spring, we announced the completion of enrollment in our imlifidase phase II study in antibody-mediated rejection episodes post kidney transplantation, and we expect to announce a first data readout in the second half of 2022 as previously guided.
Regarding our GBS program, we recently implemented several initiatives to increase the enrollment rate and enable the completion of enrollment in the second half of 2022, with subsequent first data readout in the first half of 2023. Last, we continue to see progress enrolling patients into our U.S. ConfIdeS trial in kidney transplantation, and we expect to complete enrollment by the end of this year as previously guided. Please turn to slide 13. This concludes our presentation, and we would now like to open the call for questions. Operator, please begin.
Thank you. If you'd like to ask a question, please press Star followed by the number one on your telephone keypad now. To withdraw your question, it's Star followed by two, and please kindly keep your questions to a maximum of three. Our first question in the queue today comes from Dominic Rose of Intron Health Research. Your line is open.
Hi. It's Dominic from Intron Health. Thanks for taking my questions. I've got three. My first question is, in the event that you're unable to get a U.S. approval by 2025, how confident are you that you can meet the repayment schedules and other requests? Question two is a short one. Does your new guidance still run through 2024? Does that mean to the start of 2024 or to the end? Question three is, should we expect a material increase in sales and marketing spend in Europe, now that you have access to more funding, and is there likely to be any change in commercial strategy there? Thanks.
Well, thanks so much for the questions, Dominic. To take the first one first. In the event we shouldn't get FDA approval by 2025, how confident are we that we should be able to repay the debt? I can say that we're confident. We have you know, multiple shots on goal and also in the U.S., there is an ability to obviously get approval later in 2025. We're quite confident, and we think that this is a great setup for us. The second question was about the runway, and we said that we now have runway into 2024, and you asked how long that is.
We cannot get closer than saying that it is, you know, well into 2024. We've essentially, you know, materially extended the runway so that we're now past some very, you know, potential, significant value inflection points, which is pretty important for us. The third question was around our expenditure on the launch efforts in Europe and the strategy. Let me take the strategy first. We're quite happy with the way that the strategy has played out so far.
We essentially seen all the key launch metrics that we put in place in advance of the launch being checked one by one, first getting a great label, which really you know singles out the patients with the highest degree of unmet medical need, which has helped us in our dialogues with payers, and through that obtain reimbursement and pricing at levels that you know adequately and fairly reflect the value that we're bringing to the table. That's the first key thing. The second is I'll focus on you know select number of key centers, and this is working out quite well. We're really seeing very nice progress there.
We expect to have north of, you know, 20-25 clinics being clinically ready to use the product, and a number of these clinics obviously having used it also. That is making good progress. We're also beginning to see now actually that the clinics are selecting good patients. We've previously said that we're not going to report on a patient level, but I can say that now that there's one report out in the public domain from the Netherlands on the first treated patient. This was in March, and it's a 29-year-old woman who's had kidney disease since childhood, has undergone two unsuccessful kidney transplants and has been on or had been on dialysis since 2016.
She then underwent successful desensitization therapy with imlifidase and subsequently also had a successful kidney transplant and was reported to be doing well. That is very encouraging to see that we're getting also positive first outcomes in these clinics. No, we do not expect to change the strategy. As far as the expenditure is concerned, it is a very efficient setup. Obviously over time there will be some adjustments.
We don't expect significant change, but there will be from time to time some bumps here and there as we roll out the product in additional countries and in geographies.
Okay. Thank you for all the details. That's great. Cheers.
Cheers.
The next question in the queue today comes from Douglas Tsao of H.C. Wainwright. Your line is open. Please go ahead.
Hi. Good morning. Thanks for taking the question. I'm just curious, Søren, when we think about the NiceR progress we've seen in terms of slowly seeing build in terms of patients treated on a quarterly basis, you know, I assume you didn't have any sales into some of the newly accessed markets over the last couple of months. At what point do you expect to see those beginning to contribute meaningfully?
Yes, it's obviously, as you point out, we've gotten access now to some quite important markets. Recently France through the early access program. Germany, we got full reimbursement recently and NICE has just published its positive recommendation. It typically takes some months from that kind of decision-making and communication to actually seeing some real impact and clinics beginning to get ready to use the product in a commercial setting. In the U.K., it will take some months before the NICE recommendation is implemented, but we certainly expect that to happen in the second half of the year.
In France, they've actually taken early action also based on the early access program, and we're quite encouraged by the level of activity and the interest from the French centers. We would hope to see some good experiences in France. France is one of the most important, I should say, transplant markets in Europe. That's what I can say at this point, Douglas.
On one follow-up, in terms of the U.S. trial, the transplant patient trial, we've seen some nice progress on enrollment towards randomization. I'm just curious, do you think that that's a reflection of perhaps better market dynamics? Or put another way, sort of the potential for the commercial ramp in the U.S. market? Thank you.
Yes. We are progressing, as I said, you know, we are seeing patients being enrolled and in parallel, we're also expanding the number of centers. We expect this to continue. Clearly there is very strong interest in the U.S. from these key leading centers to participate and also hopefully generate, you know, good results, which is also supported by the overall political environment, I should say, or the regulatory environment, with a focus on trying to double the transplant rate in the U.S. between 2020 and 2030. That's helpful.
I would say though that just in general, for the U.S., both for the trial and the market, and that also applies to Europe. I have had the great privilege to be involved in a number of transformative product launches. It's always exciting. It can be very challenging and complex. In this case, it's certainly exciting. There is an added complexity in that we are also dealing with the kidney allocation, the organ allocation systems in multiple geographies. We need to make sure that they're adjusted so that these patients that previously had not really been offered too many organs and so on, that they get offered organs at the appropriate rate. That's obviously something that impacts both the clinical trials we're running, like the ConfIdeS trial, as well as the commercial uptake.
Okay, great. Thank you.
Thanks, Douglas.
Thank you. Next in the queue, we have a question from Zoe Karamanoli of RBC Capital Markets. Please go ahead. Your line is open.
Hi. Thank you for taking my questions. Two questions from me, please. The first one on the debt financing transaction. It would be helpful if you can give us some color how much of the $150 million of repayment is based on regulatory milestones versus royalties. The second question on the enrollment of patients. The rate of recruitment in the U.S. kidney trial seems to have slowed down a little bit in Q2. I'm wondering, any reason why this might be, and how are you still confident that you can complete the recruitment of the remaining two-thirds of the patients by year-end? Thank you.
Thanks, Zoe. Let me take the second question first and then hand over to Donato on the debt financing we've just announced. As I said, you know, during the first part of the call, we are confident that we will be able to accomplish our goal of fully enrolling the Comf I deS trial, getting the 64 patients by the end of the year. Yes, there has been some slowdown in, you know, in the short periods, but you know, this will be by its very nature a little bit volatile. Generally what you are seeing and what we have been seeing is this kind of snowball effect.
If we go all the way back to when we started getting the first patient by the very end of last year. This is normal for clinical trials, and we certainly expect to see quite a number of patients and the remainder of the patients involved in the second half of this year. We see no signs that should not be possible. Of course, a big question mark is that links a little bit to what I said in response to Douglas' question. There is this complexity of organ allocation. Clearly we enroll patients, meaning that they provide consent. They're then in the study. They're waiting for organs to be offered in the study and then be randomized at that time point.
We're still in early days, right? We're following that very closely. You know, how long does it take and so on. Clearly, as I said, enrolling patients, we do expect to have it fully enrolled by the end of the year as things currently stand. Then I think I'll hand over to.
Yes.
To Donato.
Yes.
You said, Zoe, that it was $150 million debt. It's $70 million debt, but Donato?
The repayment amount is 2x, basically SEK 140 million. We have not disclosed, obviously, as you've seen in the press release, how much is met at milestone and how much is royalty related. What I think I can say is that we obviously have tried to come up with a repayment schedule that, on the one hand side obviously does not front load everything and on the other hand side also reflects the fact that we're expecting obviously increasing sales over time. As also indicated, the last day when the SEK 140 million has to be repaid is end of 2028.
You can basically, you know, assume that there's a meaningful spread or payment schedule over the period from when we expect a potential U.S. approval versus the end of 2028.
Okay, thank you.
Thanks, Zoe.
Our next question comes from Adam Karlsson of ABG Sundal Collier. Please go ahead, Adam. Your line is open.
Hi, all. Thanks for taking my questions, and congratulations on the financing arrangement. The graph you showed on that financing deal suggests that the minimum payments to NovaQuest would be around $70 million. Is it fair to assume that that potential catch-up payments ensure that NovaQuest are at least made whole? Or would minimum payments imply sort of payments close to, say, $100 million, for instance, ensure some reasonable return for NovaQuest? Am I reading that graph accurately, is the question, I guess. Thanks.
Yeah. Thanks, Adam. Again, I think I'll hand over to you ,Donato, to answer to.
Yeah.
To start.
First of all, let me say, obviously, this graph is kind of illustrative. We have tried to capture the concept of this deal in this graph. It's not necessarily meant to show or represent the exact numbers. What I would like to, or Hansa would like to answer is, the principal is $70 million. What we have to be repaid by end of 2028 is, obviously we need to pay back the $70 million principal plus another $70 million in terms of their return. This is where the $140 million comes from and the 2x comes from. That's how this is structured.
Basically, 2x overall repayment, of which $70 million, so 1x, is basically repaying the principal, and 1x is providing the return to them. If that answers your question, Adam.
Yeah, no, that's helpful. I guess the question is sort of how much of that difference that's the second part of it, the $70 million-
Mm-hmm.
...that's variable. Whether the structure of the deal is such that, you know, it's fair for us to assume basically that it'll be a, you know, a 2x return for NovaQuest.
Yeah.
That we should count on that $70 million, basically.
Yes. I mean, you have to. It's capped there, but it's also.
Mm-hmm.
Kind of the minimum. They're not going to get less.
Mm-hmm.
We are not going to pay more.
Okay. No, that's very clear. Thank you.
Yeah.
Maybe a second question on the capacity for expanding the clinical pipeline and the appetite for going into some of the potential new indications now following this funding. Does that guidance of a cash runway into 2024 assume any potential meaningful expansion of your clinical programs into new indications, or is it based on the structure and size of the clinical program as it looks now?
Donato, do you want to take this one?
The guidance does allow for at least for initiating a certain expansion into maybe one or two more indications. We're also considering the fact that, as mentioned, we obviously want to, at the right point in time, certainly not this year, but then going forward, as we see the U.S. trial progressing, also want to start to invest in a potential preparation of the U.S. launch.
Mm-hmm.
That's considered.
Okay. No, perfect. Maybe a third and final question from me on the AMR readout that we're expecting now in the second half. I was wondering maybe two parts to it. If you can share what parameters, sort of what endpoints we might expect in that readout. Will it just be sort of a top line that the trial was a success or not, with the data to follow maybe into 2023 at a conference or so? Or can we expect sort of a hard data on primary and/or secondary endpoints?
Second part of that question, perhaps, whether there's any more detailed guidance on when that readout might come now that we're into the second half of the year, if you have a more granular picture of that. Thanks.
Yeah. Well, thanks for that question, Adam. I mean, the primary endpoint really is donor-specific antibodies, right? Obviously, when we say that we'll come with a high level kind of readout, it's gonna relate to that essentially. So we consider what our kind of tentative conclusion based on the top-line results that we've seen. I cannot be granular as to how granular we'll be. It will be the typical high level kind of readout, and then you'll see subsequent more detailed reporting, and you know, using normal kind of timelines for that, right?
I think we'll have a pretty good picture by the end of the year as to whether we consider this a successful study or not, and I think that that's the main part.
No, perfect. On the timing of the readout, anything more than second half or are you sticking to that guidance for now?
Yeah. I mean, I think we're looking at the latter part of this year before we're able to again. I mean, there's the six-month follow-up period, so by the nature of when we had the last patient in and so on, we're looking at, yeah, the very last part of this year.
Okay, all clear. Thank you very much and, congratulations, again.
Thanks so much, Adam.
The next question today comes from Jacob Michèl of Kempen. Jacob, please go ahead.
Hi there, and thank you for taking my question. What are the timelines for the data updates from the post-approval study for imlifidase in the EU? I have a second question on, we're seeing some interest on the topic of redosing with imlifidase. Are there any study plans to answer that question of whether redosing is possible or what are your thoughts on that issue?
Thanks, Jacob for those questions. First, regarding the timeline for the post-approval efficacy study in Europe. Essentially there is a, as we communicated, we've gotten the first patient now. We'll see how fast the enrollment will be. It's a great way to generate experience in key centers and obviously generate additional data. We have a kind of a legal and mandatory requirements to finish the study by the end of 2025. I can't predict, you know, at what point we will kind of finish it. There's no urgency per se. Obviously, everyone wants to get additional results. As I said, there's no urgency.
There is several years for us to do this. The second question was around the redosing. Here clearly we're talking about the next generation of Hansa's NiceR program, which is in preclinical development currently with our lead candidate completing on enabling toxicology studies this year. At the back end of that, we will hopefully be able to take a decision to move it into the clinic next year. I can't say specifically in what area, but hopefully we can do that. I personally see that as a very, you know, significant potential value driver.
Okay. I see. Thank you very much.
Thanks, Jacob.
As a reminder, if you'd like to ask a question today, it's star followed by the number one on your telephone keypad. Our next question goes from Johan Unnérus of Redeye. Your line is open.
Thank you for taking my questions, and thanks to all for this presentation so far, especially the funding arrangement that also caps the minimum at SEK 140. I presume that if it progresses according to plan, there is some benefit to your partner that they will receive the payment slightly earlier. Looking at the graph, it suggests that the majority of the payment, if progressing as planned, will come from royalties or shouldn't we read anything into that?
Thanks, Johan. You're right in your whole statement there, but I'll hand over to you again, Donato, who just provide some details.
Sure. Thanks, Johan. I take that, Klaus and I need to be more diligent on when we do these graphs. As I said, I mean, this is really just illustrative. It's not meant to indicate that we're paying more on royalties or paying more on milestones and so on. I mean, at the end of the day, I think what we have agreed with NovaQuest is that we will provide a 2x return latest by the end of 2028. Whether this is, you know, mainly through royalties or mainly through milestones, you know, that will obviously depend very much on how the sales dynamics is going to be in the period from, presumably, you know, 2025 through 2028.
That's why I can't really answer that question, but what I can say, the graph is not meant to try kind of, you know, emphasize one over the other. It will really depend on how quickly we see the uptake in the US, for example, and where we are with our sales, obviously, Europe at that point in time.
Yes. My next question is perhaps also a bit difficult. Up until end 2024, if we look at the run rate, not any repayments or anything else, is there any how close to breakeven could you come?
You tell me. I don't know. I don't have a crystal ball. It just depends on so many things. I think what I wanna say here is really that yes, breakeven could be possible by 2024, but our focus is really to create value out of the platform that we have, right? I think there was a question about, you know, adding maybe additional indications for imlifidase and so on. We're really looking into that because we really believe that we have a platform that is so versatile that it's really worth investing in it, and we want to invest in that. That's maybe how I can answer that question.
Yes. The more successful you are, the more opportunities you will have both in terms of partnership and funding, of course.
Indeed.
The last question is perhaps also a bit difficult to give a clear answer. You had a very good first half of the year now, both Q1 and Q2, and you also activated a lot of centers and even more centers are ready to accept patients. Is it reasonable to expect higher product sales in the second half, or how should we think about the second half compared to the first half?
Well, let me take that question, Johan. We've not provided guidance-wise, and we'll continue not to provide guidance for the short term at least because this is a very, very complex market. Lots of uncertainties. There's a high degree of volatility, you know, from quarter-t o -quarter, as we've discussed in the past. When you have a situation where one patient is worth, you know, a few hundred thousand EUR, and it's a few centers, and they have one patient in one quarter and then maybe, you know, one in the second and so on, it's just impossible to predict. I'm not gonna do this, but I can say that we're encouraged by what we've seen so far, right?
We're checking the you know launch metrics boxes and so far so good. Typically you obviously see a pickup but I would really caution and say don't project anything certainly not using any linear models based on what you've seen here. It's going to continue to be volatile from quarter to quarter. The key thing is are we seeing the right centers being activated? Are we seeing the right centers having good experiences? We talked to that during the first part of this call.
Excellent. Thank you.
Thanks, Johan.
Finally, our last question today is from Christopher Uhde of SEB. Please go ahead.
Hi. Thanks for taking my questions. Quick question on the AMR trial. In the past, you know, you've discussed the potential for a number of your programs for where the phase 2 trial could be a pivotal trial potentially. Do you intend to approach regulators at just, you know, to see whether they would consider accepting the data for a potential accelerated approval? Or is that off the table at this point? And what's your-
Thanks, Christopher. I'll say nothing at this point in time is off the table. Obviously, we'll have to wait and see, you know, get the results, and then we'll make a decision based on that. It is a, you know, small phase II trial. It's the first that we're doing in this space, and we'll just have to wait and see and then have interaction with regulatory authorities. Based on advice and feedback and so on, we'll kind of decide, and obviously we'll discuss that also. At this point in time, I just can't say.
Thanks very much. If I could just have one quick follow-up, on the sales. Do you feel like this is a floor in the level of sales that we could expect, now it's around the same level for a couple quarters? Thanks.
Again, what is a little bit special about this situation is the fact that this is not chronic therapy. It's a one-off shot, you know, 15-minute infusion and that's it. Then the patient hopefully is ready for transplant and would not come back. In addition to that, the value of one patient is very high, as we just talked about, right? For that reason, you would really expect this to be extremely volatile. Therefore, I cannot say that now we have a certain floor and therefore we just expect, you know, increases and steady growth or even, you know, exponential growth at some point. This is just too early.
As I said, it's very encouraging to see the general reception that the product has gotten in the market from the key centers, how they're taking action to actually putting in place local protocols, identify patients relevant to therapy, and putting them up for, you know, receiving organ offers. We've also seen, as I said, certainly one reported, you know, very good case in the Netherlands, which is quite encouraging. So far so good, but I just can't give any specific guidance on the sales numbers for the remainder of the year, other than, you know, we've seen good progress so far, and over the coming years we certainly expect this to continue.
Thanks so much.
Thank you.
We have no further questions in the queue, so I'll hand the call back over to Søren Tulstrup for any closing remarks.
Well, thank you very much, operator, and thank you everyone for your time today and your interest in Hansa Biopharma. It's been a pleasure to report, I think encouraging results and also, a good financing deal that enables us to finance key projects, value-adding projects for the coming years. And we look forward to keeping you updated as ever about progress. With this, thanks so much and have a great day.