Mendus AB (publ) (IMMU) Earnings Call Transcript & Summary

Welcome to Mendus Q2 Report 2024. [Operator Instructions] Now I will hand the conference over to the speakers, CEO, Erik Manting; CFO, Lotta Ferm; and CMO, Jeroen Rovers. Please go ahead.

Good morning, everyone. Thanks to Mendus Q2 2024 business update. My name is Erik Manting, CEO of Mendus and today, I'm joined by our Chief Medical Officer, Jeroen Rovers and our CFO, Lotta Ferm. As a summary of the second quarter of 2024, we raised roughly SEK 69 million in April through the exercise of warrants that were associated with the financing that we carried out in 2022 -- 2023 sorry, with participation of all major shareholders, management and also Board members. We're very happy with our current shareholder bases and also with the fact that they all contributed to this point of financing. We also have had some board changes and importantly, a new Chairman of the Board in the personnel Sven Andreasson, and very happy Sven was willing to step up to this role. He is someone with a very broad experience both in Europe and the U.S. and has been on both sides in the pharmaceutical industry and the biotech industry, and brings a lot of also business development expertise. So we're happy with Sven as new Chairman. Very importantly, in the second quarter, we did a lot of immunological research on the samples we collected in the ADVANCE II trial. And we presented those data at the CIMT and EHA conferences, and they confirm proof of concepts that vididencel acts as an active immunotherapy in AML, and we'll spend some time in the coming slides on what that exactly means. Also very importantly, we announced in the first quarter, a collaboration with the Australasian Leukemia and Lymphoma Group, ALLG and also ethics committee approval to start the AMLM22-CADENCE trial, which is a combination trial with our product vididencel in current standard of care in AML. Following the ethics committee approval, we immediately engaged in starting up the trial, which means that we ship material to Australia, and we work with the clinical centers to make them ready for including patients in this trial, and we'll provide an update in the coming slides. We have, as a very important part under the late-stage development strategy for vididencel engaged in a manufacturing alliance with NorthX Biologics, which is a manufacturing organization based in Sweden. The reason it's so important is that we need to be ready for large-scale production to support our clinical trials going forward and also in the end for commercial launch. And you want that to be the same process. So working with NorthX Biologics to establish a large-scale manufacturing facility and in the end, also large-scale GMP manufacturing, is something that is a very important pillar under our strategy. And we have, in the first half of the year, already completed the manufacturing facility, but now also performed the first large-scale rounds, which we completed successfully as part of setting up this facility. We presented positive data from the ALISON trial in ovarian cancer at the ESMO Gynaecological Cancers conference. We'll discuss those in detail. And also in July, we announced that we have established a collaboration with Institut Bergonié, which is a leading cancer center in France to selling our intratumoral primer ilixadencel in soft issue sarcomas. As financial highlights, we have a strong cash position of SEK 130 million, which has provided us with cash runway into the third quarter of 2025 based on current activities, which means also the activities we will discuss today. We had a relatively limited cash burn of SEK 22 million in the second quarter. And the reason it is lower than the net result is that the investments that we have made to establish the manufacturing with -- manufacturing alliance with NorthX Biologics have been prepaid. So they are -- as we are progressing that alliance costs but they don't weigh on our cash burn. And finally, we carried out the reverse stock split, which was resolved at the Annual General Meeting and has actuated in June. Moving to our lead program, vididencel in AML. Acute myeloid leukemia, or AML, is a very aggressive blood-borne tumor. The only way to suppress it is with very intense chemotherapy and also, there's hardly any cure. The only cure actually that or treatment that is potentially curative is completely replacing a patient's immune system with a donor immune system that's called the hematopoietic stem cell transplant or bone marrow transplant. The biggest problem with AML is actually relapse due to residual cells and patients that are not able to undergo the transplant are particularly sensitive to relapse, and that's related to residual disease or measurable residual disease in short, MRD. And even after transplant patients relapse, so relapse is also the main reason for transplant failure. Five-year survival is very low in AML. And it means that there is a big need for therapies that will basically maintain disease-free periods for these patients much longer than what's the current situation. So we are developing vididencel as an AML maintenance treatment. It's meant to provide longer periods of relapse-free and overall survival. And also very importantly, maintenance therapies should be able to deliver this without harming health or quality of life. There's currently no approved immunotherapies in AML. There is a big impact of immune checkpoint inhibitors in solid tumors. It's a class of drugs that does provide for long-term survival in a range of solid tumors, but they have simply not been effective in blood-borne tumors. And that's why there's such a high medical need for new immunotherapies that could address this need for novel maintenance treatments. The ADVANCE II trial, as a summary, is a trial that was treating 20 AML patients in a first complete remission after high-intensity chemotherapy but still with measurable residual disease. We treat these patients with 6 intradermal injections of vididencel. And we did this trial with 10 participating hospitals throughout Europe. The active study phase has already been completed and patients are now in long-term follow-up. This is the data we last presented. It's at a median follow-up of 31.6 months. And what you will appreciate is that a large group of patients is actually in long-term survival. Actually, the majority of patients is still alive in the long-term follow-up and median relapse-free survival currently stands at 2.5 years. What we have now performed in the last months and presented at the CIMT and EHA conferences, is a much more detailed analysis of the immune responses following vididencel treatment. And what we were able to show is that vididencel has a very broad impact on the immune system. We had already in previous presentations, at conferences has shown that the product leads to T-cell responses against specific tumor-associated antigens, or WT-1, PRAME and RHAMM in the majority of patients. So what we were now able to show is that, first of all, there is a difference between patients that respond very well to the treatment and patients that relapse despite the treatment, and that has to do with the baselines health of the immune system. But what we were also able to show is that vididencel generally improves the immune status of patients. And finally, and this is the data we presented at EHA last June. We could show that those patients that have good immune responses, meaning T-cell responses at multiple time points, but also above median levels of B cells, so cells that make antibodies. They were all in the long-term survival curve. And this is very important because it provides proof of concept that vididencel indeed acts as an active immunotherapy in acute myeloid leukemia and that the immune responses are relevant because they result in long-term survival benefit. As a summary of that concept, it's important to understand the difference between active and passive immunity, active immunity is something your own immune system builds up. It also comes with immunological memory, and it provides long-term protection against disease. It's very different from passive immunity, which you get from injecting antibodies or, for example, also immune cells that have been manufactured outside the body, they will deliver an immediate response, but they are not long-lasting. Now the fact that we see after vididencel treatment these broad immune responses associated with durable disease control in the majority of patients is proof of concept that vididencel indeed, acts as an active immunity leading to long-term immune protection in this case, the majority of patients in the ADVANCE II trial. Currently, the only approved AML maintenance treatment is a drug called oral azacitidine. It's a chemical drug. And what you see here is a picture from the registration trial, Phase III trial for oral azacitidine. And what you see is that there is a discrepancy between the placebo-treated group, the blue group and the red group so the azacitidine treated group, but it's a temporary difference so that the chemical drug slows down the disease, but it doesn't cure it. There is an attractive side to azacitidine, and this is documented in literature but azacitidine has an effect on cancer cells and makes them more immunogenic. And that is a good combination with immunotherapy, such as vididencel. And therefore, we expect the potential synergistic effect in the combination. And we've also seen initial promising data in our own preclinical work and also some initial positive data in our Phase I trial. So there's a good basis to combine vididencel with oral azacitidine [Technical Difficulty] therapy. As a big step forward, we have set up a collaboration with the Australasian Leukemia and Lymphoma Group. It's a very renowned clinical research group. It's a big group of Australian and New Zealand-based but also a few Asian centers that are collectively called ALLG. They were also one of the leading research groups in the trial we previously showed that got oral azacitidine approved, and they have already set up a large trial that allows companies to do research in combination with oral azacitidine, and Mendus is now one of those companies that is working with ALLG and we are combining vididencel with oral azacitidine in the AMLM22-CADENCE trial or in short CADENCE trial. Now the CADENCE trial is a 2-stage trial design. Initially, we aim to open up 9 clinical centers in Australia and treat 40 patients for an initial safety analysis of the combination vididencel and oral azacitidine, subject to a positive safety evaluation, that stage will be followed by another 100 patients for efficacy segment. So this is a large trial. We're working with one of the best centers in the world. So we're very happy that we are entering -- that we've entered into this collaboration. And what I mentioned earlier, in the second quarter, we have been particularly focused on getting the trial up to speed so following ethics approval, the clinical team and the regulatory team has worked closely with hospitals and the CMC team has made sure that the material is in Australia already to treat patients, and we expect the first sites to open in September. Now it adds up to a path to market that we are preparing for. So we have the monotherapy data, the proof of concept data from ADVANCE II. We are entering into the start of the CADENCE trial, and that will deliver a larger set of data in combination with current standard of care with oral azacitidine. In parallel, we are preparing for pivotal stage development. And the reason we do this is we want this product to be ready for pivotal stage development. We are currently in the preparation phase, which means that we are preparing the eventual registration trial protocol. We're also seeking regular feedback from the regulatory agencies. So the EMEA -- sorry, the EMA and the FDA, and we want this program to be translated into a clinical trial protocol by mid next year. In parallel, we are developing the large-scale manufacturing. So manufacturing has to be there in order to not only support the trial but also in the end to allow for commercialization. And we are currently in the implementation phase of moving our process. That's a large-scale manufacturing process we have developed at Mendus to the manufacturing facilities at NorthX in Sweden. One of the other things we did in the first half of the year is extensive market research. We looked into the maintenance opportunity for vididencel in acute myeloid leukemia using both public sources, but also a broad series of interviews with key opinion leaders, so doctors, experts in the field in both Europe and the U.S. We came to an estimate that addressable market based on the current therapeutic setting of around USD 3.7 billion. And this is an indication that the market is sizable. The reason is that the need for maintenance therapies is so broad and also that so far, we have not seen any restrictions related to our product in the type of patients we can treat. So it's not limited to, for example, specific mutations. This is really a drug that can address the broader maintenance market and also comes with an attractive market opportunity. And then next to the current setting, which is the setting after chemotherapy, there's also additional maintenance populations that we could address. And that includes the second post-transplant. Again, also after transplant, there's a lot of relapses, actually the main cause of transplant failure in AML and also, there's a new group of patients, which is not treated with high-dose chemotherapy, but with the combination of azacitidine and a new drug called Venetoclax and also those patients now have a better chance of a first complete remission and would require maintenance therapy. So there's a broader market opportunity next to the current already attractive market opportunity. So as a summary outlook for the AML program, the proof-of-concept data that is the combination of the survival data and the immunotherapy data that sort of immunomonitoring data that I just described, supports the mode of action of vididencel in active immunotherapy in AML. We are already in the process of expanding clinical development in combination with current standard of care oral azacitidine in the collaboration with ALLG and the first sites of the AMLM22-CADENCE trial will open in September for recruitment of patients. In parallel, we are preparing the registration trial protocol for vididencel AML, including the feedback from regulatory agencies, it supported this exercise by an already strong regulatory dossier, and we are implementing the large-scale manufacturing in our collaboration with NorthX Biologics. We should be ready for, let's say, entering the program into late-stage clinical development, which is something we can do by ourselves. We're in a partnership, but we want the program one way or the other to be ready mid next year. The near-term milestones from the AML program are the survival update from the ADVANCE II trial that we expect to announce in the fourth quarter. So we are still following up those patients in the long-term follow-up phase of the trial. The start of the patient recruitment of the CADENCE trial, with the first sites opened in September. Moving to ovarian cancer. As a general principle, we were just interested to see if we could make vididencel work as a product in an indication outside of AML. And we chose ovarian cancer because it's one of the deadliest gynecological diseases, again, due to tumor recurrence. For the initial treatment, chemotherapy and surgery is generally not enough to get rid of the disease. So together with the University Medical Center in Groningen, we've set up a trial with 17 ovarian cancer patients to see if we could trigger relevant and new responses in ovarian cancer. We provided an update on that trial in June at the ESMO Gynaecological Cancers conference. The trial is fully recruited with 17 patients. And at week 22, the majority of patients that was treated, so 10 out of 17, still had stable disease. The other 7 had image-confirmed recurrence. We're following up those patients now in long-term follow-up to see a potential clinical benefit from the treatment. What we have established in the meantime is that vididencel is triggering immune responses against a broad range of antigens that have been shown to be relevant for ovarian cancer. And the product also has a confirmed very good safety profile in this indication. So the part of immunogenicity and safety is very good. And we also aim to have the primary analysis based on the immunomonitoring of all 17 patients in the fourth quarter of this year. Clinical benefit is dependent on the long-term follow-up, and we will, of course, also provide updates on how that is developing. As a summary, the safety and feasibility of vididencel in ovarian cancer is confirmed already in the ongoing Phase I trial, the ALISON trial. The immunomonitoring data are positive. We are seeing tumor-directed immune responses in the majority of patients treated. Primary readout in the fourth quarter based on the immune evaluation of all treated patients and potential survival benefit dependent on what we will see in the long-term follow-up of these patients, which is ongoing. Then shifting to ilixadencel. It was a product that already had shown safety and signs of clinical efficacy in a broad range of hard-to-treat solid tumors. We had 2 challenges with the product, which was one, we wanted to improve the manufacturing, which we have taken care of. But secondly, also, we needed to reposition the product. And the main reason was, and that's a broader lesson learned for the field as a whole in the cancer immunotherapy field, is that it is very difficult to improve on the immune checkpoint inhibitors as a class of drugs. I mean checkpoint inhibitors have made a big impact for the cancer immunotherapy field, then a lot of trials were performed to see if other immunotherapies could improve their efficacy, and that has not materialized. So we need to think different on how to approach solid tumors with immunotherapy. And what we have done with ilixadencel, which is an intratumoral primer is we've basically learned all the lessons from the trials we have performed, which is both monotherapy data, but also data in combination with other drug, the tyrosine kinase inhibitors and checkpoint inhibitors. It's safe in those combinations. But also, we've taken the other lesson into account, meaning that we were looking for tumors that are currently not responding to immunotherapies, specifically immune checkpoint inhibitors. And soft tissue sarcomas is one of those tumor types that is in that category and which could benefit from ilixadencel as a means to engage the immune system in the treatment of those tumors in combination potentially with other drugs. That was the background. We have been looking for a long time to do a good quality trial with ilixadencel to prove this concept in soft tissue sarcomas, and we've now taken a major step in the collaboration with Institut Bergonié, which we announced last July. I will hand it over to our Chief Medical Officer, Jeroen Rovers, to describe in more detail the collaboration in the trial.

Yes, thank you, Erik. So it's a pleasure to be able to give a bit of the background of the next clinical trial, which we are initiating in collaboration now with a group of French cancer centers. So they are, say, collaborating in this, what we call REGOMUNE trial, but I'll give you a bit of the background in the next slide. against soft tissue sarcomas to reiterate what Erik was just saying, is one of these tumors, which is still very hard to handle. It's a rare type of tumor, which arises mostly from soft tissue, like fat muscles, blood vessels, et cetera. And typically, they are not discovered at an early stage but slightly later. So often, they are already, say, metastasized, which makes them even more difficult to handle. When they're small, you can still resect them through a surgical procedure for instance, or irradiate them. But unfortunately, the majority of these tumors is not, say, eligible for that. So this cancer often recurs and it's poorly responsive to the available therapies, such as chemotherapy, and it also has shown thus far to be poorly responsive to, say, immunotherapy. So this is typically one of these indications where we feel that the intratumoral immunotherapy approach, which we are able to provide through ilixadencel might make a difference. So we announced mid July, so just before the holiday period in most countries, that we are initiating this collaboration with Institut Bergonié. This is an institute in Bordeaux, France, and I'll show you some of the details later. The collaboration means that we will add a cohort to an existing trial, which is run by Institut Bergonié and several other cancer centers in France. This is the REGOMUNE trial, and that's a Phase I/II trial where they are combining already 2 existing and approved drugs in solid tumors, which are regorafenib, which is a TKI, the tyrosine kinase inhibitor and avelumab, which is an immunotherapy. So it's a checkpoint inhibitor or PD-1L inhibitor in this case specifically. So if we look at the collaboration, then like I said, Institut Bergonié is one of the leading cancer centers in France. In this case, it's in Bordeaux. And this trial is a multicenter trial. So it's a collaboration of 7 major French cancer centers where they are recruiting patients in for different indications into this REGOMUNE trial. And in the trial, the intent is to see how the combination of tyrosine kinase inhibitor and a checkpoint inhibitor might improve say cancer results. And this trial is already then supported by the providers of these 2 approved drugs, so regorafenib by Bayer and Merck provides avelumab. And Mendus will provide, say, ilixadencel to set up a cohort where we combine these 3 products. So it actually means that ilixadencel will be administered to soft tissue sarcoma patients twice while they are being also treated with both the TKI regorafenib and also the checkpoint inhibitor, avelumab. We feel confident that the combination is feasible in applying based also on the fact that we have already previously conducted clinical trials where we combined ilixadencel with regorafenib, for instance, but also with a checkpoint inhibitor. And the latest of that is, of course, the ILIAD trial where we combined ilixadencel with a checkpoint inhibitor and shown that it's safe to have these 2 different immunotherapies work together. So in summary, for ilixadencel, like Erik already explained, we have conducted in the past several clinical trials and we've shown sign of clinical efficacy in typically some hard to treat solid tumors like the renal cell cancer. And we're now moving into, say, the clinic again with ilixadencel to show or to try to show the effect of ilixadencel in soft tissue sarcoma, which is a very hard-to-treat tumor as indicated. And the collaboration with Institut Bergonié will evaluate this combination. And we will prepare in the next few months together with Bergonié for this trial to be say -- this cohort in this trial to be approved so that we can start treating patients next year. And I will hand over back to Erik for the continuation.

Thanks, Jeroen. As concluding remarks, we now see as a combination of the survival data and the immunomonitoring data, a very important proof of concept for vididencel in AML, where it provides a potential solution for a very high medical need for a lot of maintenance treatments. And particularly important is the fact that vididencel acts as an active immunotherapy with a good safety profile that is able to deliver durable pinnacle responses in AML. That drives us to prepare the program for pivotal stage readiness. That will be an important catalyst for our corporate development, and that includes also the manufacturing side of things. But also it's an important catalyst for potential [Technical Difficulty] opportunity. So the [Technical Difficulty] for the registration trial to make sure we have the protocol ready and to make sure that the program is ready to enter that phase is currently top of our mind. The market research we performed in the first half of the year confirms the attractiveness of the AML maintenance market for vididencel. And also, there is a potential to broaden that market potential by addressing additional AML maintenance populations. And then our other pipeline programs which is the ovarian cancer program and the ilixadencel clinical program that we described today, but also our preclinical NK cell program are all well positioned to deliver on additional upside. We have multiple milestones until the year-end, which is the survival update of the ADVANCE II trials, so the long-term follow-up update of the patients in the trial. The start of the patient recruitment in the CADENCE trial and the primary analysis of the ALISON trial but also in the background, of course, there's a lot more activity ongoing related to our manufacturing alliance and related to the preparations for the pivotal trial for vididencel. So with that, I would like to conclude the update and hand it over for Q&A.

[Operator Instructions] The next question comes from Chien-Hsun Lee from Pareto Securities.

So a few questions from me. Can you tell us a bit more about the interaction you have with the regulatory authorities regarding the pivotal AML trial? And is there any clarity on the potential feedback and the amount of patients?

Thanks, Chien. Jeroen, do you want to answer that question?

Yes. I think it's well known, of course, that interactions with regulatory authorities are often a timely process. So we are in the midst of that process. So we cannot provide you with any outcome of, say, the discussions held. The outcome of these interactions from both EMA and FDA will be known towards the end of the year.

Okay. Maybe another question. So since you have shown a promising linkage between vididencel triggering active immune responses and the survival benefits, can we expect this kind of immune response to be further studied in the CADENCE trial?

Yes, that's correct. So the first part of the CADENCE trial will, of course, also include say, the immunomonitoring assays as we have performed also in the ADVANCE II study. And so we will definitely be able to compare the kind of immune responses we saw in the ADVANCE II trial with the kind of immune responses we hope to see also in the combination with oral azacitidine.

Okay. Perfect. Yes.

Thanks for joining, Chien.

The next question comes from Soo Romanoff from Edison Group.

Congratulations on your collaboration with the Institut, given that it's not a Mendus-sponsored study, can we -- when can we expect to hear an update on the trial? And assuming that the data is supportive, what would the next steps for the program be?

Yes. So like indicated, we will now start together with Institut Bergonié, the whole process of getting say the regulatory approval required for amendment of, say, the REGOMUNE trial with the inclusion of the cohort incorporating ilixadencel, so it's expected that will take the rest of the year. So once, of course, the study is able to start recruiting patients, we will inform everybody that this will happen. But you're right, it's a study conducted by Institut Bergonié in collaboration with the additional, say, cancer centers there in France. And it's up to them to execute on this.

Let me 2 elements, maybe, Soo to the answer to your question. First of all, I think what I tried to describe in the way we have repositioned ilixadencel, we have to adjust not only as a company but also as a field to the new reality, which is that the immune checkpoint inhibitors have had a major impact in the treat of solid tumors and it's been very difficult to improve the efficacy where they are effective. So we have to think very different. That is the main goal of the soft tissue sarcoma, which we will now want to include in the REGOMUNE trial because these soft sarcomas are not responding to checkpoint inhibitors by themselves. So to see if ilixadencel can bring that impact in this group of tumors will have, let's say, a broader effect on the way we see the possibilities for the product. And that is a major step in the direction of the development of ilixadencel. And secondly, you're right, some of the trials we are doing, in particularly the CADENCE trial, the ALISON trial and also the REGOMUNE trial, are investigator-sponsored rather than company-sponsored that makes them, first of all, very cost efficient. But also there is a reason why we are able to work with these very renowned centers. These are all high-quality centers, and that's for all the trials we've been doing both the ADVANCE II trial, which was with 10 centers throughout Europe, the ALLG trial, ALLG being one of the leading groups doing hemato-oncology cancer research and now also with Institut Bergonié and also the other cancer centers, which include centers like, for example, Gustave Roussy and Institut Curie, it's a broad group of centers but very renowned leading centers in cancer research. So the fact that these groups want to work with us also says something about the potential of the trial. So that's the other element of the collaborations we have set up.

Yes, that's great. And it sounds like it's very promising. What's the rationale for participating in this very broad study? I think we're the combination arm with one of the 17 cohorts versus an exclusive trial. Are you considering any other indications at this stage?

Well, the long story short is we first need to deliver proof of concept of what we just described, right? And you want to do it in the most actual setting. So with the most relevant combination of drugs available. This is a trial sponsored by Bayer and Merck with regorafenib and avelumab as a promising combination and now we have the chance to demonstrate ilixadencel has an impact in that setting. So it's a very high-quality trial and the fact that it's part of a broader trial of course, makes it interesting for context, but the most important part is that we can treat up to 43 patients, which is a significant patient population in such a rare indication like soft tissue sarcomas in this high-quality setting. So in itself, the trial is very valuable. The trial are -- and we are now setting up with ilixadencel in soft tissue sarcomas with also the broader context of the trial, both the quality of the centers but also the support from the pharma companies makes this a high-quality setting to be part of.

Yes, it's great.

Thanks, Soo.

The next question comes from Christian Binder from Redeye.

I just have one quick follow-up regarding REGOMUNE. I mean you mentioned that it's a very resource-efficient way for you to get some clinical data, of course. But can you elaborate a little bit more in terms of how much resources you will need to dedicate to that trial? Is it just supplying ilixadencel? Or for example, will there also be some financial commitment and how that's going to affect your burn rate and funding runway?

Yes. Like I said in the beginning, Christian, this is -- we consider this part of our current activities, also the way we communicated it in the past. So we were planning for this trial, obviously. So the statements we make about our cash position and the cash runway includes also the setting up and the start of the REGOMUNE trial. Secondly, the investigator-sponsored trials generally are a very cash-efficient way to get access to a large data set without, let's say, fully paying for it as a company. But it depends, of course, on the willingness of the other sites to work with us. So it's a mutual commitment. And it means that we are supported as a company. We need to deliver the drug. We're also very intimately working with the centers involved to make sure that the hospitals are trained and they know how to treat patients with our products, but also an important element, which we have also described for the ADVANCE II trial and which will be part of the CADENCE trial, which is the immunomonitoring part, which is, for us, a very important element of assessing the effectiveness of our product is also something that we will include in the REGOMUNE trial. So the basic concept that we want to prove is that in classes of tumors and in this case, specifically soft issue sarcomas, where the immune system has difficulties finding the tumor, ilixadencel can make the difference. So also as part of the trial, we will work closely with Institut Bergonié to make sure that we can collect this kind of immunomonitoring data. And that is the way these collaborations work. And for the rest, yes, we're just very proud we can work with these centers, and we're obviously very happy we can do so much with relatively limited cash burn while generating valuable data for the company and for our products.

Perfect. That was all from my side.

Thanks, Christian.

The next question comes from Antti Siltanen from Inderes.

I wanted to first ask about now your understanding of the immune system activation after vididencel is increasing. So do you see a possibility to use this understanding for patient selection in the pivotal stage trial?

Well, generally speaking, and that's also for example, the case with the immune checkpoint inhibitors, Antti. If a product is safe, there is no reason to exclude patients, right, because you want to have the upside of the benefit. So checkpoint inhibitors, they're only effective in 10% to 20% of patients in responding tumors, so still everybody gets them because the side effect profile is so beneficial of immunotherapies. And that is something which we also expect around vididencel, so the safety profile of the product is excellent and also the differences we have seen both at baseline. And then also in a way we use this and build up immunity after vididencel treatment is a very clear pattern because it's not black and white. It's not like you can really put a finger on saying, this has to happen, otherwise the patient will not respond. So generally speaking, both based on the safety profile and the fact that there is a bit of a gray zone between patients that will respond and not respond. In the end, of course, with the clear cut outcome, it doesn't, at this point, at least make us go in the direction that we want to exclude patients on floor and maybe, Jeroen, do you want to add to that?

No, I think you addressed the key points, Erik. I think it's clear that we observe the connection with say immune responses and survival. But currently, it doesn't allow us to preselect patients which might get this effect.

I think the only thing we are seeing, Antti, and this is a crucial principle, which I hope we also explained in the slide that explains the mode of action of vididencel and the positioning of our product is the level of disease. So one thing that not only we but also the field as a whole has learned is that cancer disturbs the immune system to the point that it is very difficult to activate it. So the best chance you have of booming the immune system actually when the disease burden is low, and that's also a consistent factor that we have seen in our clinical trials in AML.

Understood. Second question on ALISON trial and ovarian cancer. So did you see any correlation there between immune responses and clinical outcomes?

Jeroen, do you want to comment on that?

Yes. I think, Antti, it's a bit too early to be able to comment on that because we are completing, say, the initial evaluation of the immune responses, for all 17 patients and to be able to see if there's a clear correlation with the clinical benefit, we need to follow them up a little bit more. So the majority of patients have to be followed up for, say, 2 years to be able to have a more solid say, conclusion and whether it has an impact on the clinical benefit.

Okay. And final question. Could you remind me of the rationale for combining ilixadencel with the tyrosine kinase inhibitor?

Jeroen, do you want to answer that? Or should I answer it?

Yes, go ahead, if you want.

Yes. So what we expect, Antti, and this of course is also the broader setting of the REGOMUNE trial is that there are benefits and synergies between different ways to influence the immune system to let's say, in the right direction against cancer. And tyrosine kinase inhibitors help to, let's say, reduce disease burden, it also seems to have a positive effect on the way the immune system works. Seems to kind of tune it in the right direction with respect to efficacy towards tumor cells. So there is an expected synergy. We have shown in our trials also that ilixadencel combines very well with both tyrosine kinase inhibitors and immune checkpoint inhibitors. So there is both, let's say, an mechanistic but also based on clinical experience showing safety in a combination, a good rationale to treat very hard to treat tumors in combination with actually both the tyrosine kinase inhibitors and the checkpoint inhibitors.

Okay. That's all from me.

Thanks, Antti.

There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

Well, I'd just like to say thanks, everybody, for joining, also the people listening in. We will be active in keeping everybody up to date. We're also looking forward to have more investor events in Sweden, of which we will make some announcements shortly about the details, but we're very happy to always be in touch with our investor bases. I hope we have given you a good overview of the activities that are going on, both visible, but also a lot of activities going on in the background. We're at a very exciting stage of the development of the company, and thank you for continuing to support us.