thank you everybody for joining welcome to the q4 finance and business update of mendes on behalf of myself and our cfo lotta fam hi everyone let's start with a summary of q4 we presented continued positive data of our phase 2 trial the advanced 2 trial in mrd positive aml at ash the american society of hematology conference end of last year the updated clinical development strategy in acute myeloid leukemia and aml aligns with the evolution of first-line treatment that we will also say a few words about how that first-line treatment is shaping up including recent updates that took place at the ash conference last december our clinical trial strategy is established to not only position for the dense cell and aml but also as an active immunotherapy in chronic myeloid leukemia or cml we have established together with our manufacturing partner northax biologics a large-scale gmp production which will support our late stage clinical development and in the end also registration and commercial launch of the product it was a very significant milestone that we accomplished in q4 to make sure that we have a good balance between the costs of the company and the additional trials that we anticipate to start in 2026 we have completed a reorganization which included the reduction of staff including the reduction of the management team and we financed the company through a directed issue with significant insider support from members of the board and myself and of course our largest shareholders combined with a 50 million loan facility that we closed with VENYA on which Lothar will comment when we do the financial update. The long-term survival data of the allison trial in ovarian cancer which we presented first at asco mid last year but then also updated to your survival in q4 confirm the safety and feasibility of ididensa as a potential combination therapy in high risk ovarian cancer let me move to the financial slide and let lotta summarize the financial situation.
Yeah, hi everyone. As you can see in the report, the net loss for the period for Q4 was 38.7 million for the operational loss, but the cash burn for the period was 20.4 million for the period. And the difference is of course was mainly related to the tech transfer to Norfx, which we have prepaid in 2023. So therefore there is just effect on the cost, but not on the cash flow. The cash position at the end of the quarter and end of the year was 64.7 million Swedish crown. And that's due to that we successfully raised 52.5 million in a directed issue. as Erik mentioned before, and it was supported by the main shareholders, by Erik and board members. We also secured a loan facility with Fenja Capital of, in total, 50 million Swedish crowns. And the reason for entering into this agreement was because we wanted to minimize the dilution for the shareholders if we had raised more capital in the directed and then there has been a higher dilution. The cash runway with this injection of cash will take us into Q1 in 2027 and if we use the additional loans where we have used the first tranche of 30 million in January. That's everything for me.
Thanks. Let me move to the data we presented at ASH. You are familiar with this picture. we have of course provided continued updates on the long-term survival of the patients that participated in the advanced two phase two trial. These were all patients that had undergone high intensity chemotherapy after being diagnosed with acute myeloid leukemia and were diagnosed with measurable residual disease which is a high risk factor in predicting let's say the probability of relapse and in the end also overall survival. The positive news is that the patients are still doing very well the patients in long-term follow-up continue to do well eight patients have now passed five-year survival and we have not reached median overall or relapse-free survival if we look at the projected five-year survival of 63 percent that compares to historical controls including for example the registration trial with oral azacitidine which is now an approved drug in this setting in leukemia of less than 30 percent so this not only let's say in terms of numbers but also particularly what you call a plateau so that you see that you really have a patient population that is stable over a longer period of time is indicative of the active immunotherapy effect that we of course aim to introduce to the benefit of patients and the data also combined with the general very benign safety profile of the product will allow us to establish a very broad positioning of vtdn cell as opposed to remission therapy across different aml subtypes so last remark about immunotherapy versus targeted therapies which are typically directed towards specific mutations both in the phase one trial and in the phase two trial we have seen no association between the outcome of the treatment and specific mutations, which means that also we can position this product independent of particular mutations in AML, and that makes it next to its safety profile highly competitive in this indication. Now, what was the update at ASH that was relevant in the evolution of first-line treatment in AML? The patients that are representing roughly half of the patient population in AML, which are either elderly patients above 75 years of age or that have other risk factors that make them a patient population which is described as unfit for intensive chemotherapy until recently had very poor prognosis with also a very poor probability of even accomplishing complete remissions. that has changed dramatically with the development of a new drug called venetoclax which is a clinical practice combined with injectable asacitidine and that combination is called venasa sometimes also said the other way around asafn but it's always the combination of oral venetoclax combined with injectable asacitidine what was interesting is that But in the paradigm trial, which was presented at ASH, this is a trial, a large trial with FIT patients or patients that in principle could undergo high-intensity chemotherapy. But here they were randomized to either high-intensity chemotherapy or venasa. The outcome of that trial, and this is a phase two trial, was that the FIT patients actually benefited from being treated with venasa versus high intensity chemotherapy there was certainly in the first year a significant difference between event-free survival that was better in the venasa treated group as compared to the high intensity chemotherapy and also there was less severe side effects less hospitalizations less icu usage less infection so this means that there will be a continued drive to position venetoclax as a first-line treatment in AML beyond the patient population that was traditionally classified as unfit and of course it's important for us as a post-remission treatment that we anticipate the evolution of the field including the broader use of venetoclax driven by its clinical success so what we are currently doing is the advanced 2 trial was a single agent trial and we had already started the cadence phase 2b trial which is a randomized trial in which we combine vitiden cell with oral azacitidin following high intensity chemotherapy but we will now also engage in the diva phase 1b trial which we are preparing with andrew way who is also the principal investigator of the cadence trial professor y has been very influential particularly also in the development of venetoclex and what we will do is in the phase 1b trial combine VDDN cell with venetoclex and acacitidin as a first-line treatment and this will allow us to much more broadly position VDDN cell as a post-remission therapy in AML. Then chronic myeloid leukemia is an indication that we have considered over a longer period of time but the development of our clinical development strategy accelerated significantly when Tarek Magal joined us as chief medical officer mid last year in 2025. Tarek has a long background in chronic myeloid leukemia and he has helped us basically put in place the strategy which will allow us to test feed the denso as an immunotherapy in CML. Now what's the relevance of this strategy in CML? Chronic myeloid leukemia, as the name says, is a chronic indication. In the past, it was like AML, treated with hematopoietic stem cell transplants or bone marrow transplants. But in the past decades, after the discovery of so-called tyrosine kinase inhibitors that are suppressing the BCR-ABL oncogene, which is a specific driver mutation of CML, the disease is more or less under control as long as patients keep on taking the TKIs. So we are seeing a fast-growing patient population because of the chronic nature of the disease. We are now already talking about roughly 300,000 patients in Europe and the US alone. And all these patients have to take TKIs on a daily basis. On the one hand, the overall survival of CML patients is now close to that of the general population. But on the other hand, and you can imagine, it's a huge burden. They have to take their tyrosine kinase inhibitors treatment for the rest of their lives. so from an immediate disease control question the treatment of CML has shifted to a quality of life question and of course with all the costs associated with treatment also a significant reduction of costs if we would be able to allow more patients to stop their TKI treatment so this new barrier in the treatment of CML is called treatment free remission or TFR and it has become a key therapy goal the problem is as soon as you stop treating patients with tkis the disease comes back that's called the molecular relapse and it's also called the tfr failure so patients have to then be put on either their original tki or next generation tki there's been an evolution in the development of tkis and that continues the the next generation tkis is is already being developed there's large companies first of all Novartis but then also in the US companies like Terns and Enliven that are developing more effective and more specific TKIs but the next wave of innovation will come from compounds that will allow patients to have a more successful TFR attempt and this is where we believe immunotherapy can play a significant role if the immune system is able to control the residual disease the probability of a successful TFR attempt will be higher now this hypothesis we will first test in a vital cml phase one trial which we are currently preparing and we hope to start this trial in the second quarter of this year subject to a timely regulatory approval of the trial we have filed for all regulatory approvals but of course now we have to wait for that approval to start the trial the recruitment in cml we expect will be a lot quicker than an aml because of the larger number of patients and also the patients already having been pre-screened to to take part in this trial so in that sense we can also quite uh good predict that in a good way predict that we will have initial data from the phase one trial confirming the safety of video dense cell in this indication and then in parallel we will start phase two trial which is called the vital tfr2 trial and that trial will specifically focus on patients that will attempt to achieve treatment free remission but they will do that after they have already failed an earlier tfr attempt now this patient population has a relatively high probability of around 75 percent to have already in the first year a tfr failure so in this patient population we hope to see in the quickest possible way in initial effect of the treatment of vd denso so with these two trials we have set out a strategy to enter cml as a very large and and also of course from a patient's perspective a high medical need indication and we hope assuming that there will be a good safety readout initial safety readout of the phase one trial to start both of these trials this year in 2026. so with that i would like to summarize where we currently stand we have the data from the ADVANCE2 trial to support a broader positioning of VTDN cell in AML. So we have now already engaged in the cadence trial and we will engage in the course of this year in the DIVA trial, which will combine VTDN cell with Acercytidine venetoclax. That combined with, of course, keeping a close eye on how first-line treatment of AML will evolve if we will continue to see separate patient populations which are classified as fit and unfit or whether we will start to see a larger shift where the decision between high intensity chemotherapy and venetoclax will become more granular. That is something we keep a close eye on and those developments combined with our own data from the trials that we have now set out will inform us of course about the best possible registration trial for VD dense cell in AML and then we are very excited of course to enter CML as a new field again starting with the vital cml phase one trial and then in parallel after the initial safety data have confirmed uh have been confirmed the start of the vital tfr phase two trial and then to conclude the ellison trial we are very happy with the data we have collected in the trial that confirms safety feasibility of vd den cell in this indication including the induction of tumor directed immune responses that were associated with with durable clinical responses we do believe that ovarian cancer related to the nature of the disease which is a solid tumor with a very demanding intratumoral environment that will probably need a combination with with other drugs that that will make the combination more effective in treating this disease so we see the ellison trial currently as a good basis for potential partnering and developing combination therapies in this indication with that i would like to conclude so the positive advanced two phase two data support the broad positioning of vd dancel as a post-remission therapy in aml so i think the course in this direction that we of course implemented with the updated clinical strategy we put in place last year was supported also by the data that were presented at ash about the evolving first line treatment landscape in aml so i think we now have an up-to-date and attractive development strategy in AML, which is basically positioning VDNCEL as broadly as possible as a post-remission treatment. We're very excited to add CML as a new indication, which is a very large indication, but also, of course, with a good clinical rationale to use VDNCEL as an active immunotherapy to allow patients to have a better chance of treatment-free remission. And for the Ellison trial data, we are happy that we have them currently at hand as the basis for potential combination therapy and potential collaboration so with that we have an exciting outlook for this year with multiple clinical milestones anticipated in 2026 and particularly of course the first in human data in chronic myeloid leukemia which we expect in the second half of this year with that i would like to open up the session for questions if you wish to ask a question please dial pound key five on your telephone keypad to enter the queue if you wish to withdraw your question please Please dial pound key 6 on your telephone keypad.
Operator
The next question comes from Jody Prakash from Edison Group. Please go ahead.
Hi. Good afternoon and thank you for the presentation. I'm covering for Arun Atkar today. My first question relates to the Phase 1B DEVA trial. Is it fair to assume that ALG will act as a primary sponsor for the study? and given that you're planning the study to start in mid-2026, are we still on track for interim readout in the second half of the year? And if yes, what kind of recruitment pace and dozing schedule is built into beneath this timeline?
Sure. Thanks, Jati, for your question. So related to the DIVA trial, it will be an investigator-sponsored trial. As you know, we work with professor andrew way in both the cadence trial and the diva trial and it's a very efficient way to explore the broader positioning of the product in aml and of course when you work with people like him and the whole infrastructure around it it's it's perfectly fine to do it as an investigator sponsor trial we are currently working with another cro to support that trial but that's just let's say a practical element of of execution the most important part is that the collaboration with professor why allows us to explore the broader positioning in the aml landscape in a very cost efficient way as you know we've also set up a daughter company called mendes australia that will allow us also to benefit from some of the tax benefits that the australian government has in place to support clinical trials that take place in australia so i I think this is a very efficient way to establish Feudident cell as a broader post-remission treatment in the AML landscape. And of course, we're very happy to work with one of the best people and an acknowledged global KOL in both of these trials. With respect to the preparations they are on track, with respect to recruitment, we do expect to recruit around two patients per month in this trial, which is relatively quicker as compared to the recruitment we've seen in the ADVANCE-2 trial and the cadence trial. And the reason is that venetoclaxinase cytidine is simply used more and more. So it's relatively more predictable with respect to the recruitment rate in this setting versus the post-chemotherapy setting. So this answers my questions with respect to the DIVA trial.
Jotje, I'm not sure if you have any other questions. yeah another question from my side and this relates to the cml studies if you can outline the plan design scale and endpoints for the two studies and what could be the expected clinical trial related costs for both the trials sure so in cml um like in aml actually with the The Advanced II trial, that was a company sponsored trial.
So also in CML, the phase one trial, the vital CML trial will be a company sponsored trial. We will run that trial together with Professor Bjorn Gertsen in Bergen, Norway, who was also very active, contributed to the Advanced II trial actually. So he's already quite experienced with the product in the AML setting. For those of you interested, by the way, there's also a number of interviews with patients in AML and CML, including a patient that Professor Geertsen treated as part of the ADVANCE2 trial. So we're very happy with that collaboration. What we will do in the vital CML trial, Jyoti, is that we will first focus on patients that have what you call a suboptimal response to TKIs. So for patients to even be eligible to try and stop their TKIs, they have to have what's called a deep molecular response. And quite a significant portion of patients don't reach that very deep levels of response of the disease to the TKI treatment. And they will never be able to attempt a treatment-free remission. But also that patient population will benefit maybe very strongly from an alternative modality to suppress the disease. so what we will first look for is safety and tolerability of the product but also what we expect to see is over time what you call early molecular responses because cml can be followed very specifically based on the vcr able oncogene you can quite quickly see whether the therapy has an effect on the levels of disease and that's why this phase one trial is not only very relevant for for the initial safety data, but it's also very relevant in terms of what we may see as an effect of fetidensal as an immunotherapy on the disease levels. Now, as soon as we have established the safety signal in the first eight patients, we are ready to start the phase two trial, and this will be a trial with Professor Tim Hughes in Australia. The TFR2 setting I just explained when we were going over the CML slide is a different one. Here patients have accomplished a very deep complete remission and they will try for a second time after having this deep molecular remission over multiple years to stop their TKI treatment. In the first TFR attempt, the failure rate is roughly 50%. In the second TFR attempt, the failure rate is a lot higher, like I said, close to 75%. So, So if we start to see improvement of the outcomes in the TFR2 trial, we know we can apply the product maybe also in the first line TFR setting and basically from both trials have an initial proof of concept of the use of VD dense cell in CML. The phase one trial will be with 24 patients. We expect roughly also there a recruitment of about, a recruitment time of about a year, but it may be more with bigger groups of patients at the same time because with AML, you're treating newly diagnosed patients. And with CML, you're basically treating patients that have already been screened prior to entering the trial. The Phase II trial will be with 36 patients, and it will take longer because the readout of a TFR signal takes longer.
Thank you. That's very helpful. No further questions from you. Thank you again.
Operator
The next question comes from Chien Lee from Pareto.
Please go ahead. like partnership or and under what kind of milestones will be a good execution point thank you thanks jen yeah so with respect to the cadence trial uh we don't provide let's say
quarter to quarter update but uh the recruitment is is uh continuing as planned um we are currently at 15 patients in the trial we hope to accomplish 20 patients in the first half of this year 2026 which will also allow us to do an initial readout in the first 10 patients of the treatment arm i must say that the recruitment rate goes up and down from month to month sometimes that has to do with strangely enough seasonal effects but you know sometimes patients are just less willing to enter into trials we had a good boost of patients coming in end of last year and now we are starting to see the first patients coming back into the trial there is competition always in aml and we also see in first line a treatment of aml new uh drugs coming in including mandolin inhibitors so you know you can never be sure that your recruitment goes fully as planned but so far we are on track and again with that initial readout uh anticipated based on the first 20 patients into the trial with respect to the future financing strategy um yeah it's clear that what we tried to accomplish and what Lota also emphasized is in the last round to avoid too much dilution and stay close to the share price and combine the equity financing with the loan facility that we have negotiated with Venya Capital. You can never be sure of course when you can do a partnering deal but when we look at the way we have adjusted the AML strategy we have listened closely to the feedback from the pharma companies that we are in touch with on a regular basis and basically they did not like the very narrow positioning we had originally proposed in the phase 3 trial that was based on the design of the advanced 2 trial which was an MRD positive patients only so now we have adjusted the strategy and of course also with the data that were presented at ASH it's becoming more and more clear that you know you have to take venetoclex and asacitidine into account as a major factor in the shift in first-line treatment of AML. So I think with the new strategy, we are on track to establish this broader positioning. When it's enough, you never know, but at least we are now on track to deliver the data that VidiDensil can be combined with basically any first-line treatment, and that will help our partnering discussions. With CML, of course, we need to always be conservative we first have to have the initial first in human data but cml is a field that is really heating up on the one on the one hand because there's new classes of of tkis being discovered novartis is now the leading party with a drug called scamblix or asiminib as a generic name in that area but there's also competition from the companies that i just mentioned including turns and alive and so there's a lot of innovation currently going on in the tkis and that also of course generates a lot of strategic interest and also investor interest in that space but next will be the treatment free remission paradigm and i think if we can show in the course of this year that we did encel is an immunotherapy modality that can deliver that support of patients to achieve more successful TFR attempts, that could be a very big shift in the broader positioning of the product in the myeloid blood cancer space. But of course, we first have to make sure we get the green light to start the phase one and then deliver the data to start also the phase two in the course of this year.
Okay. Thank you very much, Eric. No further questions.
Thanks for joining, Chen.
Operator
There are no more phone questions at this time. So I hand the conference back to the speakers for any written questions and closing comments.
Thank you. Rick Romanius from RedEye was unable to join, but he sent in a few written questions. His main questions were about the approval routes, both in CML and AML. in aml like i said we first need to collect the data in the broader patient populations being post chemo and post vanesa and then of course we need to see how the first line treatment landscape shapes up we expect to be in a position to make that assessment in the course of 2027 and that will also guide our registration trial strategy in aml of course we have done everything to prepare for that including the large-scale manufacturing of the product but i think it was a tactical uh correct decision that we took last year to first focus on the broadening of the positioning of the product rather than try to get it registered on the basis of the of the post chemo setting and specifically for mrd positive patients only so that is one one one part of the answer i can't say too much currently about the registration trial strategy in cml because it's so early days but what will help in CML is that the historical basis including the data that are quite predictive of outcome are all there so it will be relatively more straightforward as compared to AML to pick up initial signals of efficacy but of course it's a different it's a different setting you can't design a trial in CML based on overall survival for example you have to design different trials that actually look at the molecular levels of the disease and in our specific case of course the improved tfr success rate so we are shaping up this strategy but i i won't go as far as to already predict what the registration trial strategy would look like in cml and then the last questions from rickett related to how much of the aml market we would capture with the positioning of vitidense cell and also the specific relation between vitidense cell and hematopoietic stem cell transplants. To put it simple, with venetoclax azacitidine and intensive chemotherapy as part of our first-line treatment after which we position vitidense cell as a post-remission therapy, we basically cover the broader patient population in aml of course transplants are still the only curative approach in aml and i don't expect and we also currently don't have a as a primary objective to compete with transplant actually what we have seen is that a number of the patients that were treated in the advanced two trial the 3d denser later on in the trial were transplanted and also transplanted successfully so So the potential of VD-dencil to initially treat patients that are not eligible or not able to find a transplant after remission has been accomplished, I think will cover the broader AML landscape. But whether or not it also makes a transplant no longer necessary will always be, at least in the near future, a doctor's choice. so we're not directly competing with transplant but we do expect to capture the broader aml landscape treatment landscape and also actually that the product will make transplants potentially more uh initially we're not able to undergo a transplant so it would be more a synergistic uh interaction than than a competing interaction um so that is i think I think the way we currently look at the positioning of the product, of course, when the success of VITIDENCEL is more established in, in the end, also a registration trial, there could be a shift towards this kind of immunotherapy, which is a lot more safer as compared to hematopoietic stem cell transplant. But at this point in time, that's not part of our strategy. I think that's it for this call. I haven't seen any other written questions, so thank you everybody for joining and we're looking forward to keeping you updated of the progress of the company this year.
