Welcome to the Hansa Biopharma second quarter and first half-year 2026 financial results conference call. All participants will be in listen-only mode.

Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions.

To ask a question, you may press star then one on a touch tone phone. To withdraw your question, please press star then two.

Please note this event is being recorded. I would now like to turn the conference over to Hansa Biopharma CEO, Renée Aguiar-Lucander.

Please go ahead.

Thank you very much. Good afternoon and good morning, everybody.

Welcome to the Hansa Biopharma conference call to review the Q2 results for 2026. I'm Renée Aguiar-Lucander, CEO for Hansa Biopharma.

Joining me today is Adam Cutler, Chief Financial Officer, Richard Philipson, Chief Medical Officer, and Maria Törnsén, Chief Operating Officer and President of the U.S. Please turn to the next page.

Please allow me to draw your attention to the fact that we'll be making forward-looking statements during the presentation, and you should therefore apply appropriate caution. Next slide, please.

This is the brief agenda for today's call. Next slide, please.

Looking at this quarter, I believe that it was a transformative quarter for Hansa. By partnering in Europe, we strengthened the commercial support for Idefirix, both in terms of resources and experience, which will enhance patient access and ensure long-term success.

In the short term, this can have a somewhat negative impact on financial performance due to the inherent uncertainties which always comes with change. Strategically and long term, I strongly believe that this was the right decision for the product, for patients, and for Hansa.

We also read out positive top-line data from the confirmatory European trial PAES, which paves the way for the conversion from conditional approval to full approval in Europe, which we hope to achieve next year. We also completed the strengthening of the executive team this quarter with the addition of Fredrik Rentsch as VP Business Development and Adam Cutler, who's making his public debut today as our new CFO.

Finally, we attended ATC, where the phase III data was presented in the form of an oral presentation and subsequently hosted a very successful Capital Markets Day on June 25th, where several leading medical experts provided their insights regarding the existing unmet medical need, clinical use observations, and real-world experience from using Idefirix in Europe. In terms of financial performance, in terms of the Q2 revenues, they were, as predicted, an improvement over Q1.

It amounted to SEK 48.1 million versus SEK 49.1 million in Q2 of 2025. Can we go to the next page, please?

Here is a brief overview of the details regarding the recent transaction. A couple of things to highlight here are obviously that post this quarter, this transaction was formally closed.

We have now also received the upfront payment. There are presently quite substantial resources focused on the transition process to ensure a smooth and coordinated handover.

The collaboration is working very well and we are now working jointly together towards the next key milestone, which is the transfer of the market authorization holdership to our new partner, SERB Pharmaceuticals. In parallel, we are obviously also working on the filing preparation for EMA, transition of personnel and information transfer regarding clinical operations as well as related regulatory quality and pharmacovigilance related areas.

Just a brief reminder of the transaction as such, it was a EUR 150 million out licensing agreement for Idefirix in the EU, the U.K., Switzerland, Norway, Liechtenstein, Iceland, and Middle East and North Africa. Our partner is SERB Pharmaceuticals.

There was an initial EUR 110 million upfront payment, which as I mentioned, has now been received. The closing took place post this quarter.

Upon acceptance by EMA of the filing for full approval, there is an additional payment due of EUR 5 million. Can we go to the next page, please?

So if we take a brief look at what we plan to focus on for the rest of the year, I have already covered a couple of the key items here, such as the transition work to SERB and filing for full approval in Europe. In addition to that, we plan to explore potential additional collaborations in gene therapy and other geographic out licensing opportunities.

Obviously, there are no guarantees that we ultimately will choose to proceed or conclude any such potential transactions this year, but it is an area of exploration that we plan to undertake starting in the second half of this year. Our key focus as an organization is obviously our ongoing interactions with FDA related to our BLA filing on imlifidase and the continued work on the comprehensive pre-commercial plan in the U.S., ensuring that we are ready to launch in Q1 subject to an approval.

With that, I will hand over to Maria, who will provide some more details on some of these topics.

Thank you very much, Renée. Next slide, please.

Our 2026 Q2 results were in line with results in Q2 2025, with a slight decrease of SEK 1 million. However, a significantly better performance, an increase of 39% compared to Q1 2026.

Our product sales were SEK 46.8 million. Performance in Q2 was particularly strong in Spain, where we recently secured reimbursement in one of the largest regions, Catalonia.

We are very pleased to see that the targeted market access efforts we put in place now has resulted in strong sales from the region. France continued to perform well, and we also saw solid sales in the other three large European countries, Italy, Germany, and the U.K.

In Germany, we have, as mentioned in previous quarterly calls, faced significant hurdles since the pause of the Eurotransplant Acceptable Mismatch program. I'm very pleased to report that in Q2, we saw the publication of the much-anticipated consensus recommendations in Germany.

These recommendations provide a practical guide to German transplant centers in how to transplant highly sensitized patients within the ETAS program. We also saw an independent article published by a German law firm confirming that desensitization is allowed under German law and highlighting that patients have a right to access the latest treatments.

We therefore anticipate that there will be future growth for imlifidase in Germany in the second half of 2026. Let's now turn our attention to the U.S.

market. Next slide, please.

The U.S. market is a growing market with very high unmet needs.

There are approximately 100,000 patients on the wait list for a kidney transplant, and 7,000 of those have a CPRA over 98%. The wait list is growing, and each year, approximately 45,000 patients are added to the wait list.

Worth noting is that the highly sensitized patients also face significant mortality, as each year, thousands of patients die while on the wait list, or they become too sick and therefore are removed from the wait list. For these patients, having access to a kidney transplant could be life-saving.

While there are 27,000 transplants each year in the U.S., there are also significant number of kidneys being discarded. According to latest data, each year, around 9,000 recovered kidneys are discarded and over 5,000 due to the reason that no recipient could be located.

Our estimate is that the U.S. market represents a $2 billion market for Hansa, taking into account the patient population above 98% CPRA.

Please turn to the next slide. Today, we are five months away from the PDUFA of December 19th.

Our pre-launch efforts are in full motion. They are led by a very experienced U.S.

team. The U.S.

leadership team have collectively launched multiple products and have experience from both the transplant market and nephrology. We have, over the last few months, conducted several market research initiatives.

They all point in the same direction, that there is a strong clinical need for quick and effective product that can enable a transplant for highly sensitized patients. Patients are also very positive to the product profile as they do not have great options today to enable a transplant.

In blinded market research, nearly nine in 10 patients expressed strong interest in learning more. While some U.S.

transplant centers have tried experimental desensitization approaches, most centers do not offer this to highly sensitized patients, as they are not perceived effective for a deceased donor kidney transplantation. In Q2, we saw the presentation of the ConfideS data at the American Transplant Congress in Boston.

We will have further presentations at the upcoming TTS in Sydney, Australia in September, and at ASHI, a conference for HLA directors in Montreal in October. We will also attend the largest nephrology conference, ASN, in October in Denver.

We continue to engage with patient advocacy groups through attending their conferences, and our field medical and market access team are actively engaging with the top 100 transplant centers in the U.S. to understand their current management of highly sensitized patients and their financial and operational profile.

Please turn to the next slide. We've also conducted various market research with financial stakeholders, both to understand their perception of imlifidase, but also to help guide our pricing decisions for imlifidase once approved.

We know that the majority of transplant patients have Medicare, but commercial plans also play an important role. The prolonged wait on dialysis is not only a significant patient burden but also a significant cost to payers.

Kidney transplants are covered by Medicare using DRG plus outlier payments and NTAP. As mentioned in previous calls, we will apply for NTAP, New Technology Add-on Payment, later this year, and our field-based market access team will be ready to provide appropriate education to support formulary inclusion by health systems, as well as support coverage decisions by commercial payers.

All of our market access team members come with significant experience in reimbursement and a track record of securing access to novel therapies. While the majority of patients have Medicare, there is a significant number of patients with commercial plans, and they will be covered via contracted rates for kidney transplants or single case agreements.

From our market research, we believe that our initial uptake will come from centers with clinical experience and knowledge of imlifidase and from large academic centers who perform large volume of kidney transplants. Already today, we have centers who have indicated interest in prescribing imlifidase shortly after potential approval.

We also expect volume to scale further post the approval of NTAP. Please turn to the next slide.

If approved, we believe that imlifidase has the potential to change the treatment paradigm for the highly sensitized kidney transplant patients in the U.S. Imlifidase can address one of the most challenging unmet needs in kidney transplantation and enable a transplant which previously was not possible.

From clinical data in ConfideS, PAES, and real-world European data, we have seen a consistent and reproducible clinical benefit. Our phase II data also show durable transplant outcomes over five years.

While there are experimental desensitization approaches which have been tried, we know that these therapies aren't effective in deceased donor transplantation. Imlifidase, therefore, has the potential to create a new clinical paradigm for desensitization, allowing a rapid and reliable reduction of antibodies to enable a transplant.

We are very excited for this significant market opportunity, if approved, we will be launch-ready at PDUFA, and we anticipate having imlifidase available in the U.S. in Q1 of 2027.

With that, I will hand it over to our Chief Medical Officer, Richard Philipson. Richard?

Thanks, Maria. Today, I am going to talk about the results of the ConfideS study that were presented recently at the American Transplant Congress.

Next slide. The results of the ConfideS study evaluating the use of imlifidase in highly sensitized kidney transplant patients were presented by Dr.

Robert Montgomery, Director of the NYU Langone Transplant Institute, who gave the presentation on behalf of the ConfideS study group. The abstract was selected to be highlighted at the closing plenary session, What's Hot, What's New, reflecting the importance of the findings for the field of kidney transplantation in highly sensitized patients.

I would like to present some of the highlights of Dr. Montgomery's presentation at ATC.

Next slide. I will start by briefly reviewing the study design.

Patients considered potential candidates for the study were consented and then to the pre-screening period. One or more unacceptable antigens were delisted from the patient's HLA profile to increase the likelihood of the patient receiving an organ offer.

When an organ offer was received, patients entered screening and underwent a final evaluation of eligibility. Eligible patients were randomized to the imlifidase arm or the control arm in a 1-to-1 ratio.

The period of follow-up in the study was 12 months from the time of randomization. Patients randomized to the imlifidase arm accepted the organ offer and were treated with imlifidase.

If treatment resulted in cross-match conversion from positive to negative, patients were transplanted and entered follow-up. Patients randomized to the control arm either accepted the organ offer, were treated with non-approved desensitization, and proceeded to transplant, or the organ offer was rejected, and the patient waited for a more compatible organ offer or offers later in the 12-month follow-up period.

Next slide, please. Here we see that the demographic and baseline characteristics were generally balanced between the two arms of the study.

It is worth noting the extended period that patients had spent on the wait list for transplantation. The mean time on the wait list was 7.3 years in the imlifidase arm and 5.2 years in the control arm.

Majority of patients in both arms had had a previous transplant, and there was a higher total level of baseline donor-specific antibodies in the imlifidase treatment arm. Next slide, please.

With respect to the primary efficacy outcome at 12 months, the eGFR was 51.5 mLs per minute in the imlifidase arm, compared to 19.3 mLs per minute in the control arm, with a statistically significant and clinically meaningful difference between the two groups of patients of 32.2 mLs per minute with a P value less than 0.0001. As can be seen from the graphic, eGFR in patients in the imlifidase arm remains remarkably stable after around day 30 post-randomization through to 12 months, which suggests favorable longer-term outcomes in these patients.

Next slide, please. At 12 months, the key secondary endpoint of dialysis dependency was statistically significant in favor of imlifidase with a P value equal to 0.0007.

A total of five patients were dialysis-dependent in the imlifidase arm compared to 17 patients in the control arm. Furthermore, when looking at eGFR categories at 12 months in transplanted patients, it is noteworthy that most patients, 92%, in the imlifidase arm had an eGFR of 30 mLs per minute or higher at 12 months, with only 8% of patients having an eGFR less than 30 mLs per minute.

In contrast, 40% of patients in the control arm had an eGFR less than 30 mils per minute at 12 months, indicative of superior kidney function outcomes in patients transplanted following treatment with imlifidase. Next slide, please.

Patient survival was 97% in the imlifidase arm compared to 100% in the control arm. One patient in the imlifidase arm died on study day 72 due to issues unrelated to graft function.

Profile of adverse events and serious adverse events likely reflected typical post-transplant complications and adverse effects associated with current postoperative immunosuppressive practice and was in keeping with previous clinical trial experience. No imlifidase infusion was discontinued due to an infusion-related reaction.

Next slide, please. As already mentioned, at baseline, patients in the imlifidase treatment arm had a higher total DSA compared to the control arm.

Nevertheless, these patients achieved a much lower perioperative level of DSA compared to controls, which was maintained at a low level for approximately one week before rebounding to a peak on day 15, thereafter progressively decreasing. Next slide, please.

Based on post-transplant biopsies, antibody-mediated rejection was observed in 57% of transplanted patients in the imlifidase arm, compared to 46% of patients for whom data are available in the control arm. Mean eGFR, both with and without AMR, was higher for patients transplanted in the imlifidase arm compared with the control arm throughout the trial period.

Evidence of AMR on biopsy did not impact kidney function. Furthermore, and importantly, both early and late AMR were successfully treated with available therapies, and no grafts in the imlifidase arm were lost due to AMR.

It is also worth noting that this was discussed with an expert panel at Hansa Biopharma's recent Capital Markets Day last month, where the consistent view was that the observed antibody-mediated rejection was consistent, predictable, and manageable. Next slide, please.

In conclusion, at one year post-randomization, desensitization with imlifidase was associated with clinically meaningful and statistically significant improvement in kidney function as measured by eGFR. In imlifidase-treated patients, the eGFR was 51.5 mils per minute, which is superior to the eGFR of 19.3 mils per minute observed in the control arm.

Imlifidase enabled successful transplantation and resulted in higher transplant rates compared with patients in the control group. At one year, five patients were dialysis-dependent in the imlifidase arm, compared to 17 patients in the control arm.

No transplants in the imlifidase arm were lost due to AMR, and imlifidase treatment was well-tolerated with a safety profile typical of transplant recipients. I would now like to hand over to our Chief Financial Officer, Adam Cutler.

Thank you, Richard. Total revenue for Q2 2026 was SEK 48.1 million, representing a 2% decrease compared to Q2 2025 of SEK 49.1 million.

Product sales for Q2 2026 were SEK 46.8 million, representing a 2% decrease as compared to Q2 2025 of SEK 47.8 million. Importantly, as Renée noted, Q2 2026 product sales were up 39% over Q1 2026.

Next slide, please. For Q2 2026, SG&A expenses totaled approximately SEK 119 million and were up SEK 13 million or 12% compared to Q1 2026 of SEK 106 million.

Compared to Q2 2025 SG&A expense of approximately SEK 91 million, Q2 2026 expenses were SEK 28 million higher. The variance was driven by increased costs associated with preparation for the expected U.S.

market launch, costs associated with the convertible debt and the SERB deal, as well as increased costs for Hansa's long-term incentive programs. R&D expenses in Q2 2026 totaled approximately SEK 68 million and were 29% or SEK 28 million favorable compared to Q2 2025.

The decrease in R&D expenses was primarily driven by the wind down in clinical trial activities and restructuring activities taken in 2025. In Q2, the loss from operations was SEK 174 million, compared to SEK 155 million in Q2 2025.

Next slide, please. Cash used in operations in Q2 2026 totaled SEK 104 million, compared to SEK 112 million in Q2 2025.

As of Q2 2026, cash and cash equivalents totaled SEK 553 million or $57 million. This does not include the EUR 110 million upfront payment received from SERB earlier this month, which would bring pro forma Q2 cash to approximately SEK 1.8 billion or approximately $185 million.

This transaction extends Hansa's cash runway and strengthens the company's balance sheet in advance of FDA approval and subsequent U.S. launch.

Headcount for the period totaled 153, compared to 140 in Q2 2025 and 122 in Q1 2026. Q2 2026 headcount reflects hiring in preparation for expected U.S.

market launch but does not yet reflect the expected transfer of personnel to SERB related to the out licensing transaction. Now I'd like to turn the presentation back to Renée for closing remarks and the Q&A portion of the call.

Thank you, Adam. Next slide, please.

In summary, Hansa is now in a strong position to realize its strategic objectives as set out. It is well-capitalized, has a clear roadmap, and has an experienced team leading all critical activities.

Our clinical data has consistently been strong, and we believe strongly support the risk-benefit thesis laid out for imlifidase. We are clearly an execution focus at this point in time, looking forward to the value inflection point in Q4.

This quarter really marks a new strategy and journey for Hansa. We look forward to sharing the future milestones of this journey with all of you over the next several quarters, and we are very excited about the future.

Next slide, please. With that, we're going to turn the call over to Q&A.

Thank you. We will now begin the question and answer session.

To ask a question, you may press star then one on your touch tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys.

If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster.

Our first question comes from Farzin Haque with Jefferies. Please go ahead.

Good morning. Congrats on the progress, and thank you for taking my question.

Maybe for Renée, now that you're roughly five months from the December PDUFA, can you characterize the pace of information requests, like any signals from the mid-cycle communication or on the CMC front with site inspections that you have received so far?

I would say that the experience of our kind of interaction with FDA to date have been very normal, as expected. I don't think that we have received anything that would cause me to be concerned or have any issues in terms of how the review is going.

We are, as you can expect, receiving consistent kind of queries, and answering them in a timely manner.

Excellent. Then one more.

You have been adding field-based market access and market and medical affairs personnel, but are there any specific things that you can do at the transplant centers ahead of approval? Essentially, to activate them and be launch-ready.

That is exactly the purpose of hiring the staff. Maria, do you want to take and explain some of the details of what these teams are actively doing in the field today and how that will assist them to be launch-ready?

Yes, happy to take the question. Yes, we have hired a field-based market access team and medical team, we are covering the entire U.S.

right now. If you look at the number of transplant centers in the U.S., as you know, there are 200 centers, and roughly 100 of those represent 80% of our volume.

The people we have hired, they are now targeted with going out to these 100 centers and basically do two things. The first one is what we call transplant center profiling.

Basically understanding who are the different stakeholders in each center, from the surgeon to the nephrologist, to the transplant coordinator, to financial stakeholders. Who are the people that are going to sit around the table and make clinical, financial, and operational decisions?

That is part of the profiling, getting to know all of these customers and also understanding who will be the champion, who is going to be the person who's going to take this on board when the product is new, and sort of bring those discussions to the broader cross-functional team. That's the site profiling.

The other aspect they're doing is what we call site readiness. Understanding where do they stand today in terms of their readiness to treat patients.

As an example, how many patients do they potentially have that are highly sensitized? Understanding how do they treat highly sensitized patients today?

How often do they see these patients? Understanding their clinical knowledge.

Do they have all the people there that will be part of this? That is part of the site readiness.

The goal is obviously to see then how many do we think will be ready shortly after approval in Q1 and who do we think is going to take maybe a quarter or two quarter longer to be ready. That is part of what they're doing right now.

Super helpful. Congrats on the progress.

Thank you.

Thank you.

Thank you. The next question comes from Matt Phipps with William Blair.

Please go ahead.

Thanks for taking my questions. Adam, I was wondering if you could help us on if the upfront payment from SERB will be recognized on the P&L in the third quarter.

Then just curious on what we will hear on the trial design for HNSA-5487 is, do we need to wait for that IND submission to kind of figure out some more of that trial design, or do you think you'd have an update sometime here in the second half before we get to year-end? Thank you.

I'll take the HNSA-5487 briefly before I hand over to Adam. I think that's the shorter answer.

We are in ongoing conversations with the FDA on that. Yes, we do hope to be able to provide some more information, hopefully when we report the next quarter.

There's clearly a target for us to file an IND before the year ends to initiate clinical studies in GBS. Sorry, Adam, over to you.

No problem at all. To answer your question, we're still sorting through the exact accounting treatment of that.

It will at least start to be recognized in Q3 of this year. It may be that the recognition of that upfront payment is spread over a longer period of time.

Obviously from a cash point of view, we have the cash. It will be on our balance sheet as of Q3, but as far as the revenue recognition, it may be spread over a longer period of time due to certain elements of the agreement with SERB.

Thank you. Maybe just real quick, should we expect any updates from the Genethon or Sarepta collaborations in the second half of this year?

In terms of the Genethon collaboration, I know that they had as a target themselves to complete a recruitment before the end of the year. That would be potentially something that could be communicated in the second half, depending on how they progress against that milestone that they have set for themselves.

Otherwise, I think it's unlikely that we'll hear anything more on the SERB agreement this second half.

Thank you for taking my questions.

Thank you. The next question comes from Thomas Smith with Leerink Partners.

Please go ahead.

Hey, team. Good morning.

Thanks for taking the questions and congrats on all the progress here. Two questions, if I could.

You mentioned that you're actively exploring some additional collaboration opportunities, particularly on the gene therapy side. Just wondering if you could elaborate a bit on the types of collaborations you're looking for and any learnings you're able to incorporate from your existing collaborations with Genethon and Sarepta.

A second question. Just at the Capital Markets Day last month, you mentioned that the results from the investigator-initiated autoimmune ANCA study with imlifidase would be evaluated over the next few weeks.

Just wondering if there's any update on this front with respect to timing or expectations. Thanks so much.

Great. I'll let Richard take the second part of that question.

With regards to the gene therapy and licensing, one of the new members of the team that will be joining us now next month, is obviously a VP of business development. This is obviously an area where we've been lacking in terms of having senior resources dedicated to that task.

With the arrival of Fred, we will have the resources that's required to a little bit more systematically and professionally pursue and follow up on quite a lot of the inquiries and questions and inbound interest that we receive, and have received on an ongoing basis. It's in the light of that new resource that I am hopeful that we'll be able to, from a resource and focus perspective, be able to address some of that inbound interest that we have been seeing and continue to see.

In terms of any details of that, I think we'll probably be able to speak to that a little bit more at the next quarterly update. Richard, do you want to take the second part of that?

As we mentioned, we did say that we've completed enrollment into the study evaluating imlifidase in ANCA-associated vasculitis investigator-sponsored study being run in Germany. All 10 patients have been enrolled.

Pharmacodynamic effects that we saw in response to imlifidase treatment were as expected. We want to collect the relevant and protocol-defined follow-up data before we can really draw any firm conclusions from that study in terms of clinical outcomes.

Patients are followed up for six months, it's going to take some extra time to gather that information for all of the patients. We'd expect to be able to update on that later in the year.

Got it. That's helpful.

Thank you, guys. I appreciate you taking the question.

Thank you. The next question comes from Douglas Tsao with H.C.

Wainwright. Please go ahead.

Hi. Good morning.

Thanks for taking the questions. Just quickly, in terms of the U.S.

opportunity, Maria, you sort of touched on the fact that this is mostly a Medicare market. I'm just curious, though, do you think that you might have a little more flexibility from a reimbursement standpoint early on to penetrate with the commercial patient population?

If you had discussions around the mechanics of how imlifidase would be reimbursed in the commercial setting.

Yes. You are correct.

The majority of patients are Medicare, but there is roughly a third of patients that have a commercial plan. Those patients will either be covered by the contracted rates with those plans or single case agreements.

I think if you look at historical launches in this space, if you look at drugs that have been launched with DRG outlier payment and NTAP, if you analyze those sort of claims, you see more commercial claims earlier on. I think that is an area that we continue to explore and in the next month or so, we'll have a meeting with some representatives from commercial plans and advisory board, to sort of gather their feedback on how that would work.

You are correct that that is a potential early launch revenue generating stream.

Maria, just as a follow-up along those lines, because I think, I'd be curious if you'velocity or got feedback or it sounds like maybe you're in the early stages, that commercial patients don't, or commercial insurers often are paying much higher rates for dialysis. I think there might be some greater urgency on the part of those payers to get patients ultimately transplanted.

Yeah. You are correct.

They do pay a higher yearly cost for dialysis for patients. I think exactly what you say is we want to have a dialogue with those stakeholders or representatives to sort of understand their perspective, because you could see a potentially quicker sort of cost saving.

If they have patients that are highly sensitized that today, the median wait time is seven years. We've also heard that there are patients waiting 10, 15 years on dialysis.

Obviously that will increase the cost not only for Medicare, but also for commercial payers. That is a discussion we'll have with those representatives to sort of better understand their perception of dialysis versus a transplant with imlifidase.

Okay, great. Thank you very much.

You're welcome.

Thank you. The next question comes from David Nierengarten with Wedbush Securities.

Please go ahead.

Hi. Thanks for taking the question.

Maybe another one on some reimbursement dynamics or other reasons that the centers that you have spoken with might not adopt imlifidase immediately. Is it largely reimbursement concerns?

When you look ahead, is it maybe not enough transplants to think about bringing imlifidase on board? What are you hearing when you talk with centers on reasons why they might not adopt it immediately?

Thanks.

I would first say that we do have a lot of interest from centers. Centers that have participated in ConfideS, also large centers where they've made pretty strong statements that they have patients waiting.

From our perspective, what we're really trying to understand is, there are two aspects. The center needs to be clinically ready, and they need to be ready from an operational and financial perspective.

That is exactly why we have our medical team being out now trying to understand where do they stand from a clinical perspective. Things we're looking for are, do they have a transplant surgeon, a nephrologist?

How does the team work? Do they have the clinical knowledge of highly sensitized patients and things like that.

From an operational financial perspective, we're trying to understand how do they today handle DRG and outlier payments, and who are the people involved? Who sits on the P&T committee at the hospital?

Getting those two aspects ready. From my perspective is, if you're not ready on the clinical perspective or on the financial and operational, I don't think that you will be ready to use imlifidase.

We're doing that work right now with the top 100 centers, as I said, to understand where do they stand. I would anticipate that you will have a group of those centers that are ready pretty quickly.

Typically as part of launch, some of these centers may be later on in that process, maybe because they need further education on the product, which we can't give until it's approved. Those are some of the things that we're looking for.

Thanks.

Thank you. The next question comes from Georg Tigalonov-Bjerke with ABG.

Please go ahead.

Hi, this is Georg Tigalonov-Bjerke from ABG. Thank you for taking my questions.

I am wondering, now that the SERB deal has formally been closed, if perhaps you're able to provide some details on the terms in the supply agreement of Idefirix, please. Are there any significant accrued on sales or base production level of cost of goods sold that we should account for in Q3?

Thank you.

In terms of kind of details of the agreement, I don't think that we're in a position to share any kind of significant details. I think that the agreement just simply states that we will continue to supply the licensed reagents as we have kind of previously been supplying the reagents.

Obviously as part of that, there's a certain kind of cost sharing, obviously, that's going to go on going forward. Considering that, obviously we no longer benefit from the revenues.

Obviously there is a portion of the cost of goods, obviously, that will also be allocated along with those revenues. Otherwise, it's really kind of business as usual, I would say, from a supply kind of standpoint.

This drug, as you know, has been kind of commercially available for several years in Europe and supply chains are, I would say reasonably kind of well established.

Okay. Thank you.

Thank you. The next question comes from Christopher Uhde with SEB.

Please go ahead.

Hi there, Christopher Uhde from SEB. Thank you for taking my questions.

Just was wondering really on what you're going to do with the cash from the SERB transaction. Obviously, you've talked about using some of it for the launch, which makes sense, do you need really all of it for that?

How much flexibility does this give you for M&A? If you could talk about maybe the breadth of therapeutic areas and given your balance sheet, the stages of development that make most sense and how creative one can be in terms of deal structures.

Thank you.

Yeah. Thank you for that.

I would say that in general, obviously, at this point in time, we don't know exactly what the world is going to look like in January. I would say that on the basis of the cash that we have, I would say that obviously we're very confident that we'll be able to really have a robust and successful launch.

You are correct, obviously, depending on the uptake commercially in the U.S., we may very well end up in a situation where we still will have surplus cash or have a strong balance sheet. I think if that is the case, I think that personally, I want to probably wait and see and know exactly what I have in terms of my cash reserve.

I think until then, I think we'll continue to spend cash wisely and appropriately. You are right that obviously it can potentially open up a situation where we can explore opportunities to in-license either complementary commercial products that are consistent with our footprint and our call point.

If that's not either financially possible or we can't find anything that we find truly attractive commercially, obviously we could also consider in-licensing or partnering in terms of a late clinical stage product. I think that these are things that we have now, I would say, the luxury to potentially explore and look at.

I will say that we will probably most likely not go forward and agree or sign up anything until it's clear to us exactly what the situation is in terms of the launch and the uptake curve in the U.S. It certainly gives us a lot more optionality and opportunities going forward to build, I would say, we're always going to stick, I would think, within limited commercial opportunities.

We're not going to go into any GP-related situations or things that require a very broad commercial infrastructure. We're going to definitely focus on rare orphan specialty products whether that then becomes rare autoimmune products or whether that is more towards the hospital products.

I guess that is something that we have now the opportunity and the time to really look into, map out, and ultimately set a strategy for that we can then pursue next year. I think it does.

Again, it's a luxury to be in this situation as a biotech company. It's exciting.

As I said, we're going to be very disciplined and wise in terms of how we spend this cash for now.

Thank you very much.

Thank you. Again, if you have a question, please press star then one.

The next question comes from Suzanne van Voorthuizen with Van Lanschot Kempen. Please go ahead.

Hi. This is on for Suzanne.

Thank you for taking our question. You've indicated that you're in discussions with the FDA for HNSA-5487.

To clarify, what are still some outstanding topics or next steps before reaching an agreement? Is there anything you could potentially share on any preliminary design?

It is really continued interactions and discussions around the design. We've had some initial feedback.

We've taken part of that feedback that's been quite clear. Some of it's been a little bit more complex to maybe interpret and identify.

We have some additional questions we want to go back to the FDA and clarify some of those points. Until we have full clarity and understanding as to what they would like to see and what implications that might have for the design, I'd rather not get into any details in terms of the design.

I think that we're certainly continuing to operate and prepare everything and certainly targeting opening an IND before the beginning of the year. I think this is something that will require a little bit more clarification and discussion with the FDA before we are ready to completely share the design of that trial.

Yes. Okay.

Thank you.

Thank you. This concludes our question and answer session.

I would like to turn the conference back over to CEO Renée Aguiar-Lucander for any closing remarks.

Thank you very much. Thank you, everybody, for listening to this Q2 report.

We look forward to sharing our Q3 report in due time.

The conference has now concluded. Thank you for attending today's presentation.

You may now disconnect.