Mendus AB (publ)

Is there anything else we still need to discuss, Robert, with respect to clues, for example, because I will explicitly invite Lothar to present her slides. I think that's your cue to switch cameras. We have at the end a big fat Q&A on the slide, which opens the Q&A. Do you want me to indicate that we're happy to take any questions? Yes, please. That would be great. And then you take over with instructions, right?

Yeah. So my introduction will sound like this. So I'll just bring it up. Welcome to Mendo's Q2 2026 report presentation. We will begin with a presentation from the company speakers, CEO Dr. Erik Manthing and CFO Lotta Färm. Following the presentation, we will open up for questions. To ask a question, press star 5 on your telephone keypad to enter the queue. When it's your turn to speak, press star 6 to unmute. I will now hand over to CEO Dr. Erik Manthing. Please go ahead.

That's okay. And then, Robert, with respect to the actual questions being asked, I assume you select which questions will be asked or by whom. Do you know the names of the analysts that follow us?

Yes, so I looked at your analyst coverage and I have Aaron Attacar at Edinson Investment Research and Christopher Liu at Lucid Capital Markets.

Yeah, but that will be a different analyst, actually.

Yeah. Okay. Do you know who it will be?

No.

Yes.

Okay, you know.

I will see it live, but it's easier for me to type it down as well. So I have a list.

Yeah, I'm just gonna look it up for you. Thank you. Let's see. The person joining is likely going to be Beibei, which is B-E-I-B-E-I, Song, S-O-N-G. Beibei Song at Lucid Capital Markets. Exactly.

Yes. And then I have Shen Sun Li at Pareto Securities. Correct. Richard Ramonius at Redeye. Neil O'Reilly at ICON. and Cecilia Stureborg von Scheele at Flare.

Flaree.

Flaree. Oh, they're in the call right now. They're not analysts. They are just other people.

No. Those were the ones that I have listed down from the registration.

Yes. The names that we went through until Richard Romanius, they are analysts.

Okay, so the other ones won't be asking a question.

Maybe, maybe not, but then at least you know where the questions come from.

Yeah, and my pronunciation on the names, was that kind of correct or?

Fleury.

Fleury. I'll type it down. And Shenzhen Li was right, correct?

Yeah. Yeah.

Okay. Five minutes to go. Four minutes to go.

Live streaming is on. We have decided to look into children's AML and the reason is that we believe we have a good basis on our adult AML program and the safety profile of the product also matches that setting and so we have started preparing and particularly also with US clinical centers potential expansion towards the pediatric setting. We have started our CML program and we have successfully enrolled the first stage of the phase one trial called Vital CML in patients with suboptimal responses against current standard of care with TKIs. And that also allows us to do, as planned, a first readout in the second half of 2026. Because we have made that progress, we have also initiated preparations for the vital TFR2 trial, which is a phase two trial in combination with SOMRI, which is a well-respected Australian research institute. And this trial will be led by very prominent Australian researchers. So it will be subject to the initial readout from the vital CML trial. But since we have so successfully recruited that first stage, we believe it was also good to already start the preparations for the TFR2 trial so that we're in a position to start that trial later this year. The clinical advisory board that has supported our clinical strategy is a group of very well respected international experts, so we're very happy with the fact that they have supported us with expert advice on the updated clinical strategy. And also, very importantly, recently there was an initiation of coverage by a US analyst from the investment bank Lucid Capital Market, which is a well-respected investment bank in the US. And this is, of course, an important step to increase our visibility towards US investors. I would like to hand it over to Lotta for the summary of the financial situation.

Hi, everyone. And for the quarter, the cost level was 20.5 million compared to 24.1 million last year for the same period. The main reason for the lower cost is that we made a big reorganization last year. So we let go of personnel. So we are more slimmed down organization right now. And we focus on the clinical trials and to take them forward. The cash position at the end of the quarter was 59.9 million, and that will take us into the first quarter of 2027. Thanks for that.

The clinical pipeline, in summary, positions our product across first-line treatment in AML. In adult AML, that comprises the chemotherapy setting, but also the less intensive first-line setting, which is called venase or phenetoclax plus azacitidine. But also, like I said, we have started preparations for a pediatric program. Those trials will guide us in the data that they produce towards the optimal path to market. Then in CML, As I mentioned, we have started preparing for two separate trials of which one is now ongoing and the second trial will be starting subject to the initial positive safety readout of the phase one vital CML trial. So the program is now on track. Again, very happy that such eminent experts in the field from the US, from Australia, from Europe have joined our clinical advisory board and have been able to provide us with the advice that we needed to set out the clinical strategy that I just described. And also, it's good to see that there is growing momentum in industry around AML and CML. In both diseases, as I will explain, there is still high unmet medical need. AML is still largely unresolved disease with a very poor five-year outcome. So the fact that there is now increasing activity in the form of financings, in the form of M&A or partnerships in both areas, AML and CML, creates good momentum and we feel that we are uniquely positioned in that competitive landscape. And also very relevant, yesterday there was a major breakthrough in the development of cancer vaccines and that validated one of the essential parts of our strategy that we have always advocated, which is that these kind of therapies whereby you train the immune system against cancer cells work best if you apply them in a setting where you want to prevent recurrence. In this case, this was a vaccine co-developed by Moderna and Merck in solid tumors, but of course, we have our own approach that specifically focuses on blood cancers. Now, what's the rationale to apply immunotherapy and specifically our lead product, VD-DEN cell, in myeloid blood cancers? The unmet need is different in AML and CML, but the principle is the same. You want to train the immune system to have a durable control over residual cancer cells. In AML, that mostly translates into survival. because the relapse rates in AML are high and relapse is almost always associated with death. In CML, that's a different story. There is a group of drugs called tyrosine kinase inhibitors or TKIs that successfully suppresses the disease, but you have to take these drugs for the rest of your life. And that is of course a big burden, not only for the patient, for the adherence, the toxicity and everything else that is associated with chronic drug use, but also for the healthcare system and the costs associated with that. So the ultimate goal in the treatment of CML is considered treatment-free remission, where we create conditions in which patients can safely stop their TKIs without the risk of their disease coming back. We know immunotherapy can be curative in these myeloid blood cancers, and the main reason for that is allogeneic stem cell transplant, or in the past it was also called bone marrow transplant. It specifically relates to a mismatch between the immune system and the cancer cells, so only the allogeneic stem cell transplants are curative, so they have to come from a donor immune system. But as you can imagine, a foreign immune system in the body has a lot of side effects. Actually, there is around 20% transplant-related mortality, and also there is significant morbidity, particularly related to a phenomenon called graft-versus-host disease, where the new immune system actually also attacks the healthy tissues in the body. But we know that the so-called graft-versus-leukemia effect is curative both in AML and CML. Other immunotherapies, have not been very successful so interferon which is an immune modulator is a very complicated drug and has not delivered consistent success and immune checkpoint inhibitors that have been very successful across solid tumors do not work and have not delivered clinical benefit in myeloid blood cancer so this leaves for us a unique positioning to address the prevention of recurrence and to establish long-term durable remissions of disease with a product that is safe. So one of the key elements of our product is that it has a good safety profile so we can apply it across these myeloid blood cancers when the disease burden is low and when the initial treatment has been successful. So that defines our positioning. In AML, as I mentioned, the main focus is to prevent recurrence. So the positioning of the product is when first-line treatment has successfully accomplished remission. And this is where the residual cancer cells can cause a recurrence or relapse. And of course, you can't continue to treat small levels of disease with very toxic therapy. So this is why we want to train the immune system to help control disease over longer periods of time. The ADVANCE-II trial is the trial that we started in this setting. And we started in patients that had levels of disease that were detectable. So this is called measurable residual disease. These patients have a relatively poor prognosis because of the presence of disease. And also in this specific setting, patients were not scheduled for transplant for different reasons. Sometimes there was no donor. Sometimes patients were not fit enough to undergo transplant. So this was an alternative to see if we could accomplish, first of all, a potential effect on the MRD, which we documented early on in the trial. We also showed that the immune responses triggered by the product were associated with these MRD responses. But of course, very importantly, we started to see what we were looking for, which is durable survival benefits. So the majority of patients in this trial, it was 20 patients, that entered the trial, 14 of those patients became long-term survivors, and 13 patients are still alive today. And as I mentioned, the last patient that was still in long-term follow-up has passed the five-year mark, so we are now going to close this trial. We are, of course, very happy with this outcome, which we also see as validating for the concept that we're after, which is to train the immune system to control residual disease leading to durable survival benefits. Now, how are we going to take this program forward? We are currently positioned in the chemotherapy setting or the high intensity chemotherapy setting. So AML patients that have a relatively good fitness are eligible for high intensity chemotherapy. And after that, they either get a transplant or they are in a very high risk of relapse. Again, we treated patients that were not scheduled for transplant for different reasons. and that is the setting that we continue to work in with two trials. The advanced two trial that we are now going to close and the cadence trial which is ongoing in Australia. The other interesting part is that the effect of first-line treatment for those patients that are deemed not fit for chemotherapy has tremendously improved due to a new drug called phenetoclax. And venetoclax is dramatically changing the AML landscape. It has led to much more successful complete remissions in patients unfit for chemotherapy, but also more and more clinical data come to the surface demonstrating that actually also for fit patients, the treatment with venetoclax combined with azacitidine could be beneficial because it results in better event-free survival in the first year. It results in less hospitalizations, less infections. But still, the overall survival or the long-term survival will be dependent on treatments that are basically effective after the first complete remission has been accomplished. So that's why we also want to combine with this specific combination of anitaplex and azacitidine so that we can capture the broader first-line setting in AML. The CADENCE trial is ongoing in Australia and the principal investigator is one of the world leading KOLs called Andrew Wei. This trial has now recruited the first 20 patients. The trial is designed actually as a first 40 patient safety trial and then with the possibility to expand it into a larger trial up to 100 patients. We have now achieved the first 20 patient enrollment and there were no product-related serious adverse events. So this is a very important initial outcome that also if we combine our product with oral azacitidine, it still maintains its very strong safety profile. And of course now also we have collected samples during the trial, so we can start looking into correlative studies that for example look into the immune system look at the levels of residual disease and this is a setting that we will further investigate and that will add to the data package that we have accumulated from the advanced two trial now then going to the other setting the venetoclax plus azacytidine setting this is a trial called diva that we have now prepared We are awaiting final sign-off of the Ethics Committee approval and then we can start the trial in the third quarter of 2026 based on the assumption that there will be a positive decision by the Ethics Committee. And that is a very significant trial because it will significantly broaden the positioning of the product in the first-line treatment landscape of AML. So we hope to announce the start of this trial soon and we are ready to engage in it. For the pediatric program, we have thought through how we can use the data that we have collected in the adult trials and specifically, of course, the long-term survival benefit combined with a strong safety profile to see if this can be of benefit for children diagnosed with AML. This will also be an expansion towards the US. So the trials that we are now preparing for will both be in the US with one trial potentially also expanding into Europe and they will focus first on the second complete remission setting, so where children have had a relapse but have successfully been brought into remission a second time. And we are also planning for a trial in the first complete remission setting, which will be very similar to the setting that we have tested in adult AML in the CADENCE trial and in the TRANS-II trial. So this adds up to a pipeline that will deliver multiple milestones. Very importantly, the DIVA trial, when it starts, we expect to recruit relatively quickly and will allow us for an initial readout in the first quarter of next year, and then an initial readout on all 24 patients that we plan to enroll in this trial in the third quarter of next year. So this will be an important validating step to show that we can combine our product safely and effectively with fenetoclax plus azacythidine. This trial, because it's the first time we administer the product in this setting, will be focusing on MRD-positive patients, because that will also allow us to pick up the initial efficacy signals based on potential changes in the MRD levels. Then the pediatric trial, as I explained, is in preparation and we hope to start that program in the first half of next year and basically address second line first and then the first line setting as a next step in potentially expanding our product towards pediatric AML. In CML, the numbers are a lot bigger than in AML when we talk about the patients affected by CML. Patients with CML are now well under control with tyrosine kinase inhibitors. The disease is well under control with tyrosine kinase inhibitors. But as explained, the real challenge now is to see if we can find conditions to allow more patients to stop their TKI. So in the past, CML was a very deadly disease like AML, and the only curative approach was allogeneic stem cell transplant. Today we have a growing number of TKIs and actually also there has been quite some innovation recently in finding stronger binding and more specific TKIs to suppress the disease. But the future again is to see if we can find conditions to allow more patients to stop with chronic use of therapy. The two main hurdles to accomplish that goal are first of all, according to the guidelines, only patients with what's called a deep molecular response or with an optimal response to TKI over multiple years are eligible to try and stop their TKIs. Now, this is a setting that for most patients is not accomplished because they simply never reach these optimal responses to TKI. So they will never become TFR eligible. The second big hurdle in CML is once patients are TFR eligible and they can stop their TKIs, actually in half of the patients, the disease shows rising levels already in the first six months and then patients can be safely put back on their original TKI or a next TKI. But of course that is a TFR failure and patients again have to see if they can find conditions under which they can stop their TKIs. This is a setting where we believe the training of the immune system may allow more patients to experience a successful TFR. The trial which is now ongoing is called VITAL-CML. It's a phase one trial in Bergen, Norway, under the watch of Professor Bjorn Geertsen. And we're very happy with his dedication. He was also one of the largest contributors to our AML trial that I just discussed, the ADVANCE-II trial. But also, of course, we're very grateful to the patients in his clinic that have participated in this trial and allowed us to recruit the first eight patients safety tolerability stage of the trial so efficiently before the summer which will allow us to have an initial readout after the summer and the trial is continuing to recruit. We are now at 10 patients and we expect that this trial will continue to recruit up to 24 patients. and that will also of course lead to a next readout in the middle of next year for all of the patients that we treated in this trial but very importantly the initial eight patient safety tolerability data are also supporting the start of the vital TFR2 trial which is a trial that we will do in Australia with one of the world leading KOLs specifically focused on TFR a professor called Timothy Hughes And that is a trial that will be in the South of Australia and Adelaide with multiple centers involved. But the start of the trial is subject to a successful initial safety readout of the vital CML trial. Both trials will continue to deliver data and specifically mid next year we expect to have data from both trials that will validate the positioning of iddn cell in CML and in both patient populations so both the patients that have a suboptimal response to TKIs where we can help more patients accomplish those deep molecular responses that we are looking for and secondly the patients that have accomplished a successful deep molecular response but that, of course, once they stop their TKIs, want to see better outcomes of their TFR attempt. The reason this trial is called TFR2 is that the TFR failure rates due to relapse are even higher in the second setting. So when patients had an earlier failed TFR attempt, the relapse rates are generally higher in the second TFR attempt. So this is a patient population we feel that would benefit most from our therapy, but of course also as a first step towards the broader TFR setting. With the momentum we have now created in the clinical pipeline, we expect a steady cadence of readouts for the next 6 to 12 months, and that will validate not only the positioning of ED Densel in AML, but also the expanding positioning in AML to include the less intensive first-line treatment, and of course the expansion of this program towards CML with an active CML program focusing on both suboptimal responders and the actual TFR challenge that we want to address in that setting. The ambition of the company is to continue to grow both with trials but also with our international presence. We have established a network of centers and collaborators across the world. Our trials have always been in multiple centers throughout Europe and now also, of course, in Australia. But now also we have a clear plan to expand towards the US. And of course, we're also very happy that the visibility of what we are doing is picked up more and more both by the clinical community and now also with the US analyst coverage that will expose us much more to US investors. So with that, I would like to thank you for your attention and open this session for Q&A.

We will now open up for questions. To ask a question, press star five on your telephone to enter the queue. When it's your turn to speak, press star six to unmute your microphone. The first question comes from Shen Sunli at Pareto Securities. Please go ahead.

We can't hear you yet.

Yeah, now we can hear you. Can you hear me? Yeah. Oh, yeah, sorry. I'm not so familiar with the new system. Yeah, thanks for the update. So, a quick question from me. So, regarding the cadence trial for the initial readout, what would you consider as meaningful apart from safety? And also, is the trial still tracking towards the larger hunger patients? efficacy stage, and will that stage be separately funded or is it contingent on this readout? Thank you.

Thanks for joining, Chen, and thanks for your question. So let me take it in two parts. First of all, when you're in the early stage of a trial, what you want to see is initial signs of efficacy and as you may remember also from the advanced true trial one of the first things you start looking for is whether the immune system responds to the treatment and of course you want to see if you can correlate that to outcomes that are indicative of efficacy initially you can't link that to the long-term survival that we have now brought to the surface in the advanced two trial so we'll look for MRD responses for example which means that the levels of disease may be varying the technical part that is important to remember is that this trial is not focusing on MRD-positive patients. So the ADVANCE-2 trial was specifically focused on MRD-positive patients. This trial incorporates the broader patient population independent of MRD. And the reason is that that's the end goal that we have in mind. And also MRD-negative patients do have residual cancer cells. So it's not that because you can't detect them, they are not there. So we don't want to exclude or on a positive basis include only MRD positive patients. And also the insights in what actually defines MRD and also meaningful MRD has shifted dramatically in the last years. So our molecular methods to measure MRD and specifically also mutations associated with AML that, for example, can be treated with specific targeted compounds, there's been an immense evolution in, let's say, our understanding of MRD and also the way MRD is used in clinical practice. So instead of looking just at MRD-positive patients and seeing if they can turn MRD-negative, which was the start of the ADVANCE-2 trial, we are first of all now not excluding patients that don't have a formal MRD positive status and we look much more longitudinally for what happens with their MRD levels which can go up and down so it's not going to be such a black and white signal as we saw initially in the ADVANCE 2 trial but we're certainly trying to get as much correlative data already early out of the trial to establish what's going on of course with the confidence level that we have from the ADVANCE 2 trial but also to be realistic this will be adding insights on top of the data we have accomplished from the ADVANCE-II trial, including, of course, the long-term follow-up of the ADVANCE-II trial. Then with respect to the path forward, the reason we want to keep optionality is that the first-line treatment landscape is changing so quickly. So where venetoclax is now becoming more and more successful in the patients not eligible for high-intensity chemotherapy, there's also more and more data showing that it may also be beneficial for the patients that are chemo-eligible. So first of all, we need to make sure that the product can be combined with honitoclax because that will enormously expand our addressable patient population. But also when you think through what could be registration trial scenarios, you have to keep this in mind. So in other words, the cadence trial can be scaled up and it can be even beyond the 100 patients that we have now planned for. into a potential registration trial or as part of a registration trial. We have also, to remind everybody of that, had a successful end of phase two meeting with the FDA based on the advanced two trial. We have successfully established large scale manufacturing and our manufacturing alliance with Northex. So in principle, this setting could be pushed into a registration trial, but we thought it wiser as a tactical decision to first make sure we can combine with venetoclax and then also at the same time keep a close eye on how the first-line treatment landscape in AML will evolve because it could well be that venetoclax becomes so dominant that the path to market is more optimal if we combine with venetoclax and there may even be an option that first-line treatment becomes a lot more granular, that we no longer separate patients black and white into chemo-eligible and chemo-ineligible, but that there will be much more interchangeability between first-line treatment with high-intensity chemotherapy, which has been around for now 40, 50 years and is still very effective. And venetoclax may be becoming a much more dominant treatment. So we want to just be in a position to be able to combine with both SettingsGen and on the basis of that, design an optimal path to market.

Okay, yeah, that's clear. Thanks for taking my question. With pleasure.

The next question comes from Richard Ramonius at Redeye. Please go ahead.

I think everybody's still getting used to the new system, Robert. Richard? Yes, I'm ready.

My first question was about your increasing activity in the US. How do you find the interest among investors in the US and in general in the pharma community for specifically CML?

Thanks, Richard. I think you more or less implied the answer in your question. But let me start with the more general remark. In the US, there are still the most advanced specialist investors that take part in biotech financings and also the bigger pockets of money. So at a certain point in time, It becomes logical to shift focus towards the US without losing your European and in our case also Nordic investor basis. We will always be mindful of all of our investors. But if you move to a situation where you expand your clinical pipeline like we are now doing, you have to be there. It's impossible to not be there. Right, but we also of course needed a basis to go there and until now we had a very successful recruitment of our trials in Europe. We have a very cash efficient way of doing our trials in Australia also because we set up a daughter company in Australia called Menace Australia that benefits from tax reductions that you get in Australia and that are actually paid back even if you're not yet a profitable company. But if you now want to step up the clinical efforts the way we want to do it, you need deeper pockets of money. So we need to be in front of US investors. Of course, what helped, and this is coincidental, we had been planning for our CML program already for multiple years. We had already presented preclinical data, so the plan has been shaping up. But what was a specific trigger for more investors and specifically US investors to look into CML was that there was a big takeover in the beginning of this year of a company called Turnz, which has been acquired for $6.7 billion by Merck. The leading company in CML is still Novartis, and Novartis has also launched a next generation TKI called Scamlix, for which they have predicted $4 billion of peak sales. So Turnz, who also has a similar compound, was seen as a potential competitor, and now Merck, of course, is into the game after they acquired Terns and then there was also another company called Enliven that did also a discovery of a new TKI and raised a lot of money in the US. So I think the playground for CML has changed dramatically. It's been for a long time seen as a field with very little innovation and when nothing was happening and all patients were under control and first of all that is not the case so when you actually talk to doctors and talk to patients you find out that the statistics are very different from the daily experience and that adherence and lifelong treatment with all the side effects and also for younger patients really having heavy impact on their lives, including not being able to raise a family, for example, is much more impactful than what you would see from clinical outcomes. So I think it's very good that there's now a renewed interest for innovation in CML. And I think we have a nice positioning because the next thing after these more improved TKIs will be increasing focus on TFR. So that's the more general answer I can give you, Richard. I can of course not comment on how individual investors perceive our story, but I just can tell you that there's growing interest in the field and therefore also growing interest in us. And of course, we're very happy that we now also have more direct visibility towards U.S. investors because of the analyst coverage that has started.

It's a great answer. I'm satisfied. Just one last quick question. Who funds the vital TFR2 study?

That will be an investigator-sponsored trial, but it will be, to a large extent, also sponsored by us. I think you understand the principle, the vital CML trial trial is now ongoing as a corporate sponsored trial. So we are formally the sponsor, but the setting in Australia with Professor Hughes is just a very well-organized setting. They've done very large trials, including also for Scamblix, for example. So they know exactly what they're doing. So we're more than happy to let them run the trial, but of course it doesn't come without costs. So we'll have to Thanks for answering my questions. The next question comes from Aron Atkar at

Edison Investment Research. Please go ahead.

I'm sorry. So I have a quick question on the expected biological information from the Candace combination trials. So could you clarify what kind of efficacy related or biological information the investor should expect from this first data set?

Yeah, I'm just going to check. This was not Aaron. This is Baybay maybe from Lucid?

Yes, yes, yes. I'm sorry.

No worries. It was not your mistake. You were just identified as somebody else. But thanks for joining the call. Well, I think in an early stage of a trial, the best thing you can do is look for initial signs of efficacy, and that's both for the AML trial and the CML trials. What we'll always try to do is to have an initial indication of how the immune system is activated. Sometimes you start to see things quite early. and other times you have to wait a little bit longer. In the ADVANCE-II trial, we've always continued to work on these translational data and they have actually just been shaping up more and more. Things we're looking into, for example, is T-cell repertoire. We're doing Eli spot assays. We've looked into how the humeral compartment compares to T-cell compartment. I can't give you a real black and white answer right now. We have started to do these analysis both in our own labs in Leiden, in the Netherlands, but also in the labs of the WIHI Institute that is associated with the principal investigator, with Andrew Wei. So the first and most important part was to establish safety. That was also the original objective, of course, of the stage one of the CADENCE trial. But these other data will come in at a more granular level. Yeah, but it will be focusing on immunological parameters that we can get to the surface and also, for example, whether we start to see MRD events that indicate that the immune system is actually taking care of the residual disease. In the CML setting, that will be very similar. So in the vital CML trial, of course, safety tolerability is the first and most important readout because it will also allow us to continue the trial and to start the TFR2 trial. But we have already started also to look into the specific gene that drives CML, which is sensitive to TKIs, called BCR-ABL, and we've started to look into immunological parameters. So also there, we hope to quite quickly already, after the initial safety readout, start to pick up what's called early molecular response data, where you start to look for levels of disease being potentially affected by the immune system. But it's hard for me to predict right now in a black and white way what we exactly will pick up, except for the fact that we will, of course, pick this up in the rest of the year. So in a relatively short period of time.

I really appreciate that. If you don't mind me to ask a follow up questions. So regarding the magnitude or patterns or BCR ABL1 reduction. So like what kind of level you would consider as like clinical encouraging early signal?

Yeah, very good question. And let's put it this way, patients that have been long time suboptimal responders to TKIs, if you can convert any of those patients to a patient with sustainable DMR, deep molecular response, That's a terrific outcome. And of course, we hope it will be other than less patients, but we're looking for those initial signals that it's possible that we can create a situation whereby the immune system becomes supportive of the TKIs and where the combined therapy will lead more patients into a DMR that eventually will also maybe make them eligible for TFR. So the initial signals can be quite subtle. But what we're looking for initially is the signals that we pick up after three months start of treatment that's formally qualified as an early molecular response. And then at the end, you also want to see the 12 month data to see if those responses continue. and so that is the initial thing we will focus on and any patient that we can convert from a suboptimal response to TKIs into a deep molecular response we will see as a success and of course if we combine that with the immunological parameters and we start to pick up that actually something is happening in the immune system like we've seen that in AML but of course we need to confirm that in CML, I think that will already provide some at least very interesting initial correlative data showing that this principle holds up.

Really appreciate that. Thank you so much.

Thanks.

And we'll try again with Aaron Atkar at Edison Investment Research. Please go ahead.

Hi there. Can you hear me?

Yeah, perfect, Aaron.

Fantastic.

Definitely getting used to the new system.

Thanks very much for taking my questions. I think most of them have been covered already, actually, but I do have two left. The first of which is, it would be great if we could get a bit more detail on the planned US paediatric AML expansion. So notably, what are the sort of the key hurdles between now and getting this programme started in the first half of 2027?

Yes, of course, Aaron, everything is subject to financing, right? So all these trials that we have been preparing for, and that's also for the continuation of the trials that we have now put in place, is of course expecting that we are able to continue to fund the company and to also add these additional trials to our pipeline. We have prepared the groundwork. That's the long story short. And the reason to move into this paediatric indications is twofold. First of all, there is a very high unmet medical need that we wish to address. And also we are very happy that we can work with some of the best centers in the world to address specifically children with AML. The other reason is that the setting in the pediatric indications allows for a quicker and also more efficient path to market, which is necessary, of course, because we're talking also about much smaller patient numbers. But for us as a company, from a strategic perspective, it means that we, on the one hand, try to make the adult AML setting as big as possible, because that has also been the main feedback that we have received from the pharmaceutical industry, that there's a lot of competing drugs based on targeted therapies and fragments of the AML population, but if we can deliver this as a therapy that applies across AML and across all of the first-line settings, or at least the backbone settings, Then, of course, that has a lot bigger commercial value. But the trials that you need to get the product to market are quite bulky and can be lengthy. So they would ideally benefit from a pharma partnership. But to have a pediatric program that is a lot more concise, both in time and in patient numbers, will allow us to also take this product to market ourselves. And that is why it combines the unmet medical needs with also a more strategic element for the company.

Okay, that's very helpful, thank you. And just one more question, reflecting again on the sort of Moderna-Merck positive news just there. Could you elaborate a little bit more on kind of what you think this means for the broader cancer vaccine field, which I think it's sad to say have sort of come up and down in terms of attention. And also, do you believe this paints a more positive light to Mendez's approach with the off-the-shelf strategy as opposed to personalized?

Yeah, that's an excellent question. Let's not make too many associations, but let's make the ones that are relevant. The most relevant is that we have discovered early on, and I think also more and more the field as a whole, including the specific setting that Moderna and Merck have been addressing, that the immune system is most effective to prevent recurrence. And not so much to suppress higher levels of disease or to, you know, in the solid tumor space, address more bulky tumor masses. the best setting to train the immune system against residual cancer cells is when you try to prevent recurrence, which is factually the largest cause of death in cancer worldwide. So it's very relevant and I think this has really been a tremendous breakthrough that we have now seen in the late stage trial that kind of effect. So hands down for the combination of Merck and Moderna for accomplishing that. What I think we should also be mindful of is that this doesn't solve everything. It starts with what makes an effective vaccine, right? Formally, we are, by the way, not a vaccine company. Our product is formally categorized as a cellular immunotherapy, but it is an immunization strategy. So with a bit of association, you could call it a cancer vaccine. There are specific details that can only provide context. which is that the solid tumors that have the highest mutation rate have also been shown to be most effective to the immune system, for example, the checkpoint inhibitor. So it's logical that firms like Moderna, but also others like BioNTech, et cetera, have started developing algorithms and technology, in this case mRNA technology, to design vaccines that can very specifically zoom in on personalized neoantigens that can become part of a potential immunization strategy. Myeloid blood cancers, where we are active, are very different. First of all, they seem to be unaffected by checkpoint inhibitors. And secondly, also to think through how we can design a product that is effective in training the immune system to take care of the residual cells. We've taken a very different principle. And the principle, again by association, not direct scientific evidence, but it's a logical thing to keep in mind, is that we have learned from the transplants that the immune system can be curative and that there has to be an allogeneic mismatch between the immune system and the cancer cells. It doesn't work if you get your own stem cells back, right? And the basic principle of allogeneic stem cell transplant is that you basically replace the whole immune system by somebody else's immune system, whereas what we have tried to accomplish is to show that if you give an allogeneic product, a whole leukemic cell with all the antigens that it carries, in a way to the patient's immune system that it triggers a broad immune response, that that also works but will be a lot safer. So there's of course parallels, and I think specifically the parallel is that the recurrence of tumours which is such an imminent a threat to the health of patients can potentially be treated by these kind of therapies. But I think we should also be mindful that such a breakthrough doesn't mean that everybody will be successful. I think it's still very important to find actual immunizations that work and that has been historically difficult. It's not that you, you know, if you look at the history of vaccines, for example, most vaccines were always designed on attenuated versions of the actual disease. And it was difficult to take them apart in individual antigens and what have you. So the fact that we now have, you know, a new standard in technology with Moderna and Merck showing that it can be done to filter out antigens and make personalized vaccines. I think that is from a technology perspective, a massive breakthrough. But I don't think we can compare that directly to what we are doing, but I think we do have a very strong rationale and also, of course, very encouraging data to point out that our product may be very well designed specifically for myeloid blood cancers.

Fantastic. Great to hear your thoughts, Eric. No more questions from me, but congratulations again on a great quarter.

Thanks, Aaron.

And with that, we conclude the Q&A session. So I hand the word back to Dr. Erik Manting for closing comments.

Well, thanks everybody for joining also on behalf of Lotte. Sorry if there were some few technical glitches with the new system, but we're very happy that we work with these people as well. So we'll continue to work on the technical details, but I think it was a great call and thanks everybody for joining.