Mendus AB (publ) ($IMMU)

Welcome to Mendus' Q1 Report 2026 Presentation. [Operator Instructions] Now I will hand the conference over to the speakers, CEO, Erik Manting; and CFO, Lotta Ferm. Please go ahead.

Thank you, everybody, for joining the '26 Q1 webcast.

Yes. Hello, everyone.

So to start with the summary of Q1, we've had a very ambitious plan that we communicated end of last year and that was based on the positive data that we have documented over time, including the long-term follow-up we presented end of last year of the ADVANCE-II trial that showed long-term survival in MRD-positive high-risk AML with now already 9 patients beyond 5-year survival. So that provided the basis for us to continue the development of the product. We are currently in a trial in a similar setting but in combination with a drug called oral azacitidine. This is applied after high-intensity chemotherapy. The trial is called the AMLM22-CADENCE trial, or, in short, the CADENCE trial, for which we wish to recruit 20 patients in the first half of 2026. It's a bit of a bumpy recruitment in AML always also in this trial. We are now at 16 patients recruited, and we're still aiming for 20 patients in the first half of this year, which will allow us to do a first readout of the trial. The preparations for the DIVA trial, which is in combination with less intensive first-line treatment of venetoclax and azacitidine, is on track. We will also explain in a bit more detail why this is relevant and how this positions us in the AML landscape. And for that trial to support that trial, we have signed a contract with Olivia Newton-John Cancer Research Institute, which is the leading cancer research institute in Australia. As some of you may know, we are running multiple trials in Australia, and we've, therefore, also set up a daughter company called Mendus Australia, which is handling not only the practical parts in the trials in Australia but also allows us to benefit from a very attractive tax incentive that the Australian government allows for companies like us that do their research in Australia. It's not the main reason we do our trials in Australia. The main reason is we can work there with the best people, in this case, particularly a professor called Andrew Wei, who has been paving the road for post-remission therapies and also for venetoclax in AML, but it's good to build out our presence in Australia to also allow for the very beneficial circumstances to run these trials. Then what we have added as an indication to our myeloid blood cancer program is CML. CML is a very large field, roughly 10x bigger than AML. It's in principle under control with drugs called TKIs or tyrosine kinase inhibitors but the quality of life of patients can be heavily affected by the continued use of these TKIs. So we have set out a clinical development strategy to position vididencel as an immunotherapy in CML and help more CML patients accomplish what you call treatment-free remission where they can live a healthy life without being dependent on day-to-day TKIs. We are very happy that we obtained all the regulatory approvals for the Phase I trial that we start with the program, the VITAL-CML trial, marking, therefore, also the start of the vididencel clinical development in CML. And that trial is now ongoing and recruited the first patients already in Bergen in Norway. With that, I'd like to hand it over to Lotta for the financial summary.

Yes. And the financial summary for the quarter was that the costs in the quarter were approximately SEK 20 million, which is SEK 10 million lower than the same period last year. And this is the effect of the reorganization and the cost savings we did in the second half of last year. And during the quarter, we have also executed on the first tranche for the Fenja loan, which added SEK 30 million to the cash position. The cash position at the end of the quarter is SEK 74 million compared to SEK 64 million at the end of Q4 2025. That's everything for me.

Thanks, Lotta. And just to reiterate, this is a cash runway that will allow us to reach the end of the year and also the main milestones of our clinical programs. The ongoing clinical programs, starting with AML are the ADVANCE-II trial, which is in long-term follow-up. Again, the patients are doing well. We're very happy with that outcome, obviously. The AMLM22-CADENCE trial is the trial that I've just described in combination with oral azacitidine is recruiting as we speak. And the DIVA trial, which is in the new first-line treatment setting of venetoclax plus azacitidine is expected to start mid this year. So we are in full preparation mode now also together with Olivia Newton-John Cancer Research to have that trial start in a timely way. Combined, the data from these trials and also, of course, keeping a close eye on how the first-line landscape in AML will evolve will allow us to set out a registration trial strategy to get this product to market. And very importantly, of course, right now, we are positioning the product in the broadest possible way to address patients that have accomplished first complete remission in AML. The CML program started with the VITAL-CML trial. It's a trial that addresses patients with a suboptimal response to current standard of care being tyrosine kinase inhibitors. But also importantly, we have already prepared or are in full preparation mode or in full preparation mode for a Phase II trial that can start as soon as we have the initial safety data from the Phase I trial and actually in parallel. So we also wish to start this trial before the year-end. And this trial will specifically address treatment-free remission, which means the final objective in CML and also what is seen as the most important treatment objective in CML to allow patients to safely stop their TKI usage. The ALISON trial, the ovarian cancer trial, we reported on end of last year. We had a presentation at ASCO. We had a 2-year survival follow-up end of last year. It's delivered basically what it needs to deliver, which is safety and feasibility in this indication. However, ovarian cancer is a quite complex disease. So we think that specifically in relation to the tumor microenvironment, which is inherent to this disease, we will need to combine it with other therapeutic modalities. And also with respect to the focus of the company, we have decided to focus on the broader myeloid blood cancer space because it's allowing us to be very competitive there. And in ovarian cancer, the competitive landscape is different. And also from, let's say, the focus of the company's perspective, the myeloid blood cancers from now on will be the main focus. But nevertheless, ovarian cancer program has been successful, and we are looking to partner it or to combine it with other therapeutic modalities. Now to start with the primary concern in AML and also later on explaining how that relates to CML. The only concern in AML is survival. It's such a deadly disease that the first and most important thing is to get it under control. Most patients unfortunately relapse and pass away despite initial treatment. The survival rate of AML is still 25% or less with current standard of care today. The only curative approach is hematopoietic stem cell transplant, and that's a dangerous procedure, which many patients cannot undergo. So the only objective in AML is to make sure patients are able to survive. And what we have done as part of our -- also giving patients a bigger platform on our websites, we have taken a few patient interviews. This patient called Jacob is -- has taken part in our ADVANCE-II trial. And the long story short is the extra life that he experiences now from day-to-day has allowed him to also see the birth of the grandchild. So this is AML. With respect to the treatment landscape in AML, there has been for 30, 40 years, really no change. It's always been high-intensity chemotherapy. which is available for roughly half of the patients. Other half of the patients are considered not fit enough to undergo this intensive chemotherapy. So for the unfit patients, which are patients 75 years and older or patients that have comorbidities and for which the high-intensity chemotherapy is not available, there's now a new drug called venetoclax, which is combined with an injectable form of azacitidine. This first-line treatment landscape is shifting. And the reason is that the venetoclax is so successful that it is now also being tested more and more in fit patients as an alternative to high-intensity chemotherapy. And actually also the first randomized controlled data were presented end of last year at ASH. And what we have seen is that the patients that were treated with venetoclax and azacitidine had a better performance specifically in the first year as compared to patients treated with high-intensity chemotherapy. So we expect a bigger shift towards venetoclax and azacitidine in the AML landscape, and we have adjusted our clinical trial strategy accordingly. In CML, the situation is very different. In CML, the overall survival is very similar to the general population. However, it requires day-to-day targeted treatment of the disease, which is in the form of tyrosine kinase inhibitors or TKIs. The TKI suppressed the disease but what is very much overlooked is the effect of the TKIs on the quality of life of patients. And these are just 2 of the interviews that are on our website. The gentleman, George Scharf, is part of the patient organization who really encouraged us to continue to be part of innovation in CML and also the young lady called Solve, who was also in our annual report, indicates how badly the TKIs are affecting her quality of life and how badly she would also like to have a chance of reaching treatment-free remission. So this is in a nutshell why we do it. The most important part of it is that the immune system in the end is also in CML considered to be the key to potential long-term survival without being dependent on tyrosine kinase inhibitors. There is renewed industry in the CML space since the discovery of a new class of TKIs. TKIs are already starting with Gleevec 20 years old in the treatment of CML. They have been developed into second-generation TKIs but more recently, third-generation TKIs have been developed that have a slightly different mode of action that are more specific for the driver mutation of CML called BCR-ABL. And Novartis, who was also the first party to enter the CML space with their TKI called Gleevec, was now also the first to enter this space with a new class of TKIs called allosteric inhibitors. And they have shown 2 things. First of all, there is still significant innovation possible in CML. And also secondly, it's a very big market that also has resulted in their case in a projected peak sales for this product called asciminib of USD 4 billion. So not surprising, another compound developed by a company called Terns is now in the hands of another big pharma company called Merck. So Merck is now helping Terns develop their compound, which is also an allosteric inhibitor to, in the end, also challenge Scemblix in the market. So there was a lot of new attention for the CML field. The relevance for us is that these new TKIs that will have deeper and better responses in CML will allow more and more patients to achieve that optimal goal of treatment-free remission because you need to have a couple of years in a row, a very deep response on TKIs before you are allowed to stop your TKIs. And when you stop, that's when the disease comes back. And this is where we with vididencel will try to improve TFR success. So actually, we are dovetailing on the success of these new classes of TKIs and more and more patients reaching these deep molecular responses. So how do we take it on to indicate -- sorry, to expand the indication to CML, you have to start with the Phase I trial and show, of course, safety tolerability. But also what we have already done is we focus on patients with suboptimal responses to TKI so that we have also embedded in the trial the possibility to see what happens on the disease level, which is what you call early molecular responses. So all those data will start accumulating since the start of the trial, and we will hope to have the first 8 patients already treated to the point that we can have a readout in the second half of the year. If the safety is confirmed, we have so far not seen any safety-related issues with our product in the clinical trials. But of course, we need to establish it now in CML then we can also start the Phase II trial. The Phase II trial will focus on patients with a second TFR attempt. It means that they have already failed an earlier TFR attempt, meaning that the disease levels were going up and they had to be reinstalled on either their existing or new TKI. But if they again reach these very deep remissions and they can do a second TFR attempt, the failure rate is even higher. In the first TFR attempt, it's typically 50% of patients fail within the first 6 to 12 months. In the second TFR attempt, it's typically 75%. So we'll have a good chance of also, in that setting, picking up signals of efficacy relatively early. So this is how the CML trial is now set up. And of course, we're very happy that the VITAL-CML trial is actually ongoing as we speak. So to wrap it up, we have an ambitious clinical development plan that we communicated at end of last year. Very importantly, it aligns with the evolving first-line treatment landscape in AML, and it will allow us to position vididencel broadly as a first-line post-remission therapy in AML, meaning across all AML subtypes, we are with our immunotherapy approach, not dependent on individual mutations. Also, we will make it independent of the measurable residual disease status because also patients that have undetectable levels of disease have a high risk of relapse. So already in the CADENCE trial, we are capturing the full spectrum of patients, including patients with undetectable MRD levels. And also, we will be after the DIVA trial in a position to combine vididencel with both high-intensity and low-intensive first-line treatment being venetoclax and azacitidine. So we'll basically capture all of the AML patients that successfully accomplish a complete remission. That will inform our path to market, and we believe that, that will be a much more optimal path to market as compared to only one subgroup of patients that we had originally planned for earlier last year. Then the indication and expansion to CML is now in effect. Trials are ongoing. And the VITAL-CML trial has already recruited the first patients, which positions us for an initial readout already in the second half of 2026, which will then also support the start of the Phase II trial. So with that, I'm very excited to report back on the first quarter and happy to take any questions from the audience. Thank you.

[Operator Instructions] The next question comes from Richard Ramanius from Redeye.

I'll start with just a very quick question. In what quarter do you expect to present the first data from CADENCE?

Richard, thanks for joining. Well, the CADENCE trial is a combination of safety, of course, in combination with oral azacitidine, which we formally have to confirm. which is important because oral azacitidine, as you know, has been approved now in the post-chemotherapy setting. So we actually have to show after the single agent ADVANCE-II trial that we can safely combine with oral azacitidine. So that's the primary objective also of the first phase of the CADENCE trial. The second phase will be an expansion phase up to 100 patients. The first phase is set up to establish safety. But of course, we will also look for initial signs of efficacy, and then we can do that also in AML on the molecular disease level. So we are doing MRD measurements, and we can look into how these MRD events evolve before and after treatment. Of course, it's slightly different as compared to the ADVANCE-II trial because the ADVANCE-II trial focused only on MRD-positive patients, whereas the CADENCE trial allow any patient to come in independent of MRD status. So it will be a little bit more granular as compared to the ADVANCE-II trial, where we immediately already started to see some patients converting from an MRD-positive to MRD-negative status. This will be a little bit more granular with respect on how MRD evolves over time. But nevertheless, it will give us a good indication about what is happening under the surface. And similarly and also very similar to what we did in the ADVANCE-II trial, we will, of course, look for the response of the immune system, both at baseline and also in correlation with the outcome with respect to the health of the patients, so whether the patients relapse or not but also over time, follow the immune responses that we trigger with vididencel to make sure that we confirm this what we have also seen in the ADVANCE trial record. And that we can do after we have incorporated the first 20 patients. It's not black and white, we have just decided that 20 patients is halfway to the first phase. So it will be a relevant moment to see what is happening as an interim analysis.

Okay. So midyear when you reach 20 patients, that's when you will present it.

Exactly. Well, that's when we will need to do the analysis. So around that time, it will not take too long, but one way or the other, of course, we have to first reach 20 patients, then open the samples, et cetera, and do the analysis. So most important is first that we get to the 20 patients and then we do the analysis, and we will report shortly afterwards.

Okay. I was wondering my next question about the recruitment speed across the different trials. How do you compare them from CADENCE to the CML trial?

Well, it's always difficult to make hard predictions, but I can give you a bit of a sense of the dynamics, Richard. So the first-line treatment in AML has always been high-intensity chemotherapy for roughly half of the patients. Oral azacitidine is now approved, but there's also, of course, patients getting other drugs in that particular setting where we are also combining with oral azacitidine with our product, vididencel. There's also patients going to transplant. There's new trials going on with, for example, a new class of drugs called menin inhibitors. So there's always competitive pressure in the landscape of AML and particularly in the chemo setting, where now a lot of people, of course, are shifting to venetoclax. Certainly, in the venetoclax, to be clear, have not been approved yet for the chemo-fit patients. But you have to think about recruitment in terms of what is going on in the actual clinical development landscape. And there, of course, a lot of the attention has shifted to venetoclax because it's such a promising drug. So a lot of the combination trials, for example, are also in venetoclax instead of the high-intensity chemotherapy setting. So this is simply a summary of how the dynamics are with respect to where patients end up with respect to ongoing clinical trials. And that is, of course, also why you always need to be on top of your trials and make sure that patients end up in your trial. But in AML, it will never be easy because it's such a tough disease. It's always incident patients, right? So they are diagnosed with AML. They need immediate treatment and they need to be allocated to your trial, somebody else's trial. So the landscape in AML is always quite competitive. And I think this is also why the recruitment of the CADENCE trial is a bit bumpy. We will nevertheless continue, obviously, to make sure that this whole setting and specifically also the safety data in combination with oral azacitidine has been accomplished. The venetoclax setting is different because there's so much experimenting going on in venetoclax, we also expect a faster recruitment of the DIVA trial. We have a very ambitious plan to recruit 24 patients in 12 months once the trial has started. So that also gives you a feeling on how the clinical development landscape and the way patients are allocated to trials is currently proceeding. And of course, Andrew Wei, who is a global KOL, but he's also involved in both of these trials. So I think we're making a realistic assessment together with him that the venetoclax trial will be recruiting quicker and smoother as compared to the post-chemo trial. With CML, it's different. CML, you have instead of incident patients, meaning patients that are newly diagnosed, you have prevalent patients. So these patients are diagnosed, they're under control on their TKIs. So actually, it's easier to screen for patients that fit your trial criteria, inclusion criteria. So that's also why, of course, we have also shown that immediately after approval, we started recruiting patients. So there, I think the recruitment will be more predictable, and that's also why we have a high confidence level we will be able to report back already on the first 8 patients in the second half of this year.

Okay. Great. Just one last question. Have you noticed any change in sentiment among -- in business development after the Terns acquisition?

Well, it always helps if there is increased awareness of the possibilities for innovation in the field. And I think for a long time, people have basically, for the wrong reasons, ignored CML because it looks on paper and with respect to the suppression of the disease to be under control, right? And now 2 things have happened. First of all, the launch of Scemblix by Novartis has shown that innovation is still possible in the TKI landscape and that it will have an impact on quality of life for patients. So that was already a major shakeup for the TKI field. And of course, then you get a lot of other companies also trying to get into that game and Terns is only one of them. but it was the one that closely resembles the mode of action of Scemblix. So I think the main thing that has happened, Richard, is that the awareness of, let's say, the pharma companies but also the investors actually in the international investor landscape for CML has grown tremendously, and we think for the right reasons. The main next hurdle, and that's also something that hematologists will tell you if you ask them what is the main objective in the treatment of CML is actually treatment-free remission. And that is where we are now, of course, also part of the bigger picture and following the path of the TKIs that will lead to more patients becoming TFR eligible.

The next question comes from Chien Lee from Pareto.

Just 2 questions from me regarding the CML study. So for the patient population being enrolled, could you maybe elaborate a bit more on the characteristics and how does the suboptimal response is defined? And the second question is that, so what kind of molecular response improvement would you consider that is clinically meaningful?

Yes, Chien, very -- first of all, thanks for joining and very elegant questions. So I think you need to think about TFR in 2 ways. First of all, you need to have perfect response to your TKIs, and it's a scale of scoring and you need to have at least a 4 log 10 reduction of your disease over many years, depending a bit on the U.S. and Europe, 2 to 3 years before you can do a TFR attempt. So if you are a suboptimal responder and you don't reach these very deep levels, you are not even eligible for TFR success. So that means that any patient in our trial that we can, let's say, convert from a suboptimal responder to a more optimal responder is already very big progress. Then, of course, you need to establish that, that response is sustainable over many years for that patient to actually do a TFR attempt. But it's black and white. If you don't have an optimal response, you will never be eligible for TFR attempt. So that's why we are so keen to combine the safety and tolerability data with also the early molecular responses that we may be able to detect in some of these patients, which will lead to a deeper response as compared to their earlier lines of treatments with TKIs. In the end, for the patients, the most relevant phase is obviously to have a real TFR attempt and to have that attempt to be successful. Now if you look about the -- if you look into the, let's say, subpopulations of patients, the suboptimal responders represent roughly 20% to 30% of the people in the chronic phase of CML treatment. The other, let's say, more optimal responders, they could, in principle, all be eligible for TFR attempt. So that is, I think, also a portion of patients that will grow with the new classes of TKI. So that is the majority of the market. It's just that because of the TFR failure rates are so high, it takes, first of all, a long time to become TFR eligible. And then if you stop and you fail to clear out the disease, and that's visible already in the first 6 to 12 months, then, of course, you have to wait for another couple of years before you can do a second TFR attempt. And that is really holding down the TFR success rate. So if you look at over a period of 10 years since diagnosis, only 25% of patients achieved a TFR successfully. And that is the bigger pool of patients, obviously, that we zoom in on.

[Operator Instructions] The next question comes from Arron Aatkar from Edison Group.

First of all, I wanted to ask about the operating income relating to the research collaboration with the biopharma partner. I'm just curious to know if you're able to share any details there. And I appreciate if not, then maybe when we might expect an update? And then similarly, can we expect a similar run rate for this other operating income throughout the year?

Yes. So let me start with your first question, Arron, about the collaboration. It is ongoing. The partner who we work with have moved their part of the program into the clinic now. I expect we may be able to speak in more detail about this program in the second half of this year. We are still in an early stage. We want to make sure that the collaboration continues and also moves into the next phase of the collaboration. So we hope to be able to say a bit more with permission of our partner in the second half of this year. And what was your question with respect to the operating cash flow?

So the other operating income this year relating to that partner, can we expect a similar run rate throughout the year for the subsequent quarters?

You mean related to the collaboration. Well, I mean, right now, the only thing that is, let's say, related to income is the fact that they pay for the program -- clinical program. It may shift, of course, to a bigger collaboration if successful. But that's also why we have been quite modest. And also the partner was not really keen on sharing the details of that program. But since it's now in the clinic, we are talking with them that we can say a bit more about it in the second half of the year.

Okay. Perfect. And then my next question relates to manufacturing. We've seen that that's sort of been a key differentiator for vididencel over the years and large-scale GMP production is now set up with NorthX Biologics. So it would be good to know if there's any other additional manufacturing milestones or similar that we can sort of be watching out for in the years to come.

Well, the most important thing is that we have established it, Arron. And that's not only, let's say, the physical part of the process, which is that you do what's called the technology transfer from your non-GMP setting, which is, in our case, our labs in Leiden to a GMP setting, which is the facilities of NorthX in Matfors, Sweden, but also that you document it all properly and that you have continued contact with the regulators that the way you have scaled up your process is in line with their expectations and also a basis to continue clinical development and in the end market registration without hiccups about, let's say, the product changing or the nature of the manufacturing of the project changing. So that is what we are constantly working on. So it's not only the, let's say, making of the batches because actually, we have made enough material to support our current planned trials. So for future trials, we will continue to manufacture more, and it's also good for the collaboration and keeping the teams trained from both sides that the manufacturing continues, but it's not actually necessary right now to continue to manufacture more because we have established actually the process and also, like I said, enough material for the currently planned and ongoing trials. But it is, of course, a collaboration that we want to keep active.

Okay. That's helpful. I did have one more question about recruitment relating to CADENCE but I think you addressed that above actually. So nothing else from me.

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

Yes. So I looked into the activity feed, and there was one message from somebody participating asking what the main purpose is of vididencel for CML, improving the TFR rate. So I hope I addressed that. It's indeed improving the TFR rate in 2 ways. First of all, making more patients eligible for a TFR attempt by deepening their response that was suboptimal to TKIs. And secondly, and most importantly, of course, to sustain those TFRs, and that's particularly relevant for the patients that have accomplished TFR eligibility and just need a much better outcome of the TFR attempt. What can we expect in this trial? I think I've alluded to that. And then there was also one written email we received prior to the presentation starting via our e-mail address, and that was about the partnering and the way the CML landscape is shaping up. I think I have addressed those questions in the answers to the people that were on the call. So with that, I would like to conclude this Q&A and also thank everybody for their participation.