Mendus AB (publ)

Good afternoon, everyone. Thanks for participating in the Mendes Q1 report of 2024. As a list of company, please pay attention to our disclaimer. To start with Q1, we made significant progress and we were proud to present that progress together with our business partners, ALLG and Northex Biologics. ALLG is our Australian partner, the Australasian Leukemia and Lymphoma Group, with who we are involved in the AML22 cadence trial. And Nordic Biologics is a manufacturing organization based here in Sweden, who are our partner for large-scale manufacturing of our lead product for the DEN cell. We also received, in the first quarter, ethics committee approval to allow for the start of the AML22 cadence trial, which is currently ongoing. And we have progress in our NK cell program, which we presented at the Aeneid Killer Summit, which is a leading conference on that specific topic of NK cell therapies. We were very happy to announce that our major shareholders as well as management and eligible board members announced their intention to execute the warrants that we issued as part of last year's financing. And in the end, we raised roughly 69 million Swedish krona through the exercises that warrants and that provides us with cash runway until the third quarter of 2025 based on our currently planned activities. With VitaDenso, we've taken initial steps towards late-stage development. We reported at the end of last year very positive data about the VitaDenso program in acute myeloid leukemia, and the data were, on the one hand, showing promising survival results, and at the same time also brought together a lot of the immunomonitoring data we collected as part of the trial. And those immunomonitoring data not only supported the mechanism of action of our product, as an immunotherapy that stimulates the immune system to act against residual cancer cells. It was also clearly associated with the clinical benefit we observed in the clinic. So, we were very happy with those data, which we presented at the ASH conference end of last year. Then, together with ALLG, the Australasian Leukemia and Lymphoma Group, we had prepared a trial with oral azacitidine, which is the current standard of care in AML maintenance. and we were awaiting ethics committee approval, which in the end we got in March and allowed us to start the trial. The registration trial, which we are planning to do in AML, is one that we are separately preparing for. So the trial is actually run by AMLG in collaboration with us, but the registration trial is a trial that you have to prepare for as a company-sponsored trial. That is a parallel track, and we are very much encouraged by initial positive feedback we received from the FDA on the steps we have planned towards that path. Also importantly, the manufacturing alliance with Northex Biologics is on track. So we started that collaboration after the summer last year. And now in the meantime, we have established a production facility, which is ready. And also the tech transfer process has started. So we've done the initial training run, including the filling of vials in the first quarter of this year. And now we are continuing with the tech transfer process, and we anticipate to be able to deliver the first GMP batches of Iterden cell based on this large scale production process mid 2025, which will also put us in a position together with the trial preparations to be ready for a pivotal stage trial. About the other pipeline programs, we have an ongoing phase one trial in ovarian cancer. pursuing the same principle we are pursuing in AML, which is after initial treatment, when the tumor burden is relatively low, we try to boost the immune system against residual cancer cells. In this case, it's ovarian cancer patients, which have undergone high-dose chemotherapy in combination with surgery. And then we provide our vaccination scheme of six vaccinations of vitidansel. And the primary endpoints of the trial are safety and immunogenicity in this indication. And we have already reported initial positive data. We will report also in 2024 on the trial, including a primary readout in 2024 second half. Our second clinical stage product is Elixir Denzel. We have been preparing this product to re-enter into the clinic after we had redesigned the manufacturing process, and we are still pursuing that route. It has faced delays. We were initially planning to enter into final negotiations around the trial end of last year. But we had to shift our focus towards another group of clinical centers and potential partners. And this process is currently ongoing. We are pursuing the program and we are aiming to conclude the discussions I just described in the first half of 2024. And then finally, we have a preclinical NK cell program, which we think is very promising because it is based on the expansion of so-called memory NK cells which are strongly associated with clinical benefits in different tumor settings. And so this is a program that could in the future become a new pipeline program based on our in-house research. Ritidansel is positioned as a maintenance therapy. And what is special about maintenance therapy is that it allows patients to stay in a disease-free state longer after initial treatment. And this is addressing one of the major challenges in cancer therapy today. So initial therapies that are, for example, including chemotherapy that address the initial tumor, they are generally successful. But the most deadly tumors, including acute myeloid leukemia or AML, are so deadly because they come back very quickly after initial treatment. Another reason to address low-disease settings is the fact that vitidan cell is an active immunotherapy. It means that it trains the immune system of the patient to build up long-lasting immunity over residual cancer cells. And that active immunity, which you can only build up through the disease itself or via vaccination, just takes time to build up. Usually a couple of weeks, but we're also seeing in our own trial two to four weeks in the first set of vaccinations is enough to start building up the immunity, but it does take some time and the immune system has to be in a good shape to be able to mount such an immune response. And this is building up to the concept which is depicted here, where we try to build up active immunity against residual cancer cells resulting in long-term relapse-free and overall survival for patients. Pilodensil has a competitive product profile. It is a cell-line-based product, which means we can affect scalable manufacturing, which we are currently, of course, carrying out together with Nortex. The nature of the product is so-called off-the-shelf. So we can make large quantities of the product, we store the product frozen, and it's ready to be shipped to hospitals on demand. Also, it's a relatively straightforward product. It can be thawed at bedside and injected via intradermal injection. And the only side effects we have seen is actually redness in the skin where we administer the product, which also supports the motivation of the product as a vaccine. We have a strong regulatory dossier, including an AT&P certificate from the European authorities around our manufacturing process, orphan drug designations in the U.S. and Europe, and a fast drug designation, which we obtained end of last year in the U.S. AML is a devastating disease and is still a largely unresolved disease. The five-year survival has remained largely unchanged, and it's only 30%. The main reason is that unless patients are able to undergo a bone marrow transplant, the disease unavoidably comes back, and disease relapse remains the major barrier to long-term survival in adult AML. Another important element about maintenance therapies is that they have to be safe. And that is one of the elements that we feel makes Svitodensel a very competitive approach. It's the combination of training active immunity to result in long-lasting control over the disease, but also a product with a safety profile that is compatible with the maintenance setting. The current standard of care for AML maintenance is oral azacitidine, and this is one of the data from the registration trial of oral azacitidine. And what you can clearly appreciate is that the blue line, which represents placebo, shows you that patients that have measurable residual disease after their initial chemotherapy relapse very quickly. Actually, the majority of patients relapse already within the first three months. With oral azacitidine, which is a small molecule chemical drug in the tablet form, you see that this curve shifts, and the median relapse-free survival is seven months. but it's still a very disappointing picture with the vast majority of patients relapsing and soon afterwards passing away very quickly. So a lot of room to improve on the current standard of care. What we have done is after a successful phase one, which showed that patients with a low disease burden had a chance of long-term durable remissions after treatment with the VitaDen cell, we started the phase two trial, which is the currently ongoing advanced two trial. And this trial, was comprising six vaccinations of fitodensil in patients that had successfully undergone initial chemotherapy, so were in a first complete remission, but still were diagnosed with measurable residual disease, putting them at a higher risk of relapse. This is the data we presented end of last year at ASH, and what you will appreciate is that after an initial group of patients relapsing and then also passing away relatively quickly, there was a remarkable large group of patients, being 14 out of 20, that was alive at the end of the active trial phase, which was a 70-week trial phase. And the great news we could report end of last year with ashes of those 14 patients were still alive end of last year. We are currently with the majority of patients alive, not at the point where we can determine an overall survival median. We do have a median relapse-free survival at the last readout of two and a half years. The most important part of this set of data is that you start to see durable remissions and durable overall survival in acute myeloid leukemia following treatment with vitidansil. Another important set of data we reported last year is so-called immunomonitoring data, whereby we study the immune system of patients. And first of all, this led to a lot of deeper understanding of how the immune system responds to vitidansil. But also very importantly, we saw that these immune responses correlated with the clinical benefit. And this is a kind of data that we continue to collect and also continue to report on, including this week at the CIMT conference. And this basically documents the immune responses, not only on the level of T cells against specific tumor antigens, but also other parts of the immune system, such as B cells, dendritic cells. And also we saw that, for example, suppressive immune cells were affected by the vitadent cell treatment, leading to lower levels of suppressor cells and increased levels of activated cells. Also, what was clear is that the patients that relapsed, unfortunately, had a very poor immune system and were hardly able to build up immune responses. So that also explains why a subgroup of patients did not respond. Currently, we are addressing patients after high-dose chemo, so the chemo fits patient population. And since oral azacitidine is now the approved drug, That is the first next step we will take. And we are doing this as we speak in collaboration with ALG and AMLM22 cadence trial. This is also the initial patient population that we will prepare a registration trial for. It is clear that also other AML patients will benefit from this treatment. And that is why we also consider to explore additional patient populations, including patients that have undergone a bone marrow transplant but are still at a high risk of relapse if they are still MRD positive, but also a new group of patients which is treated with a new drug called Hunitoclax, leading to more patients in a complete remission in a group of patients that was traditionally deemed chemo unfit, but with much higher remission rates that also creates a patient population that will benefit from maintenance therapy. So the CADENCE trial, as I said, is now starting with Ethic Committee approval out of the way. We have shipped material to Australia. We're starting up the clinical sites. The first phase of the trial will comprise 40 patients, equally divided over azacitidine alone or azacitidine with fitodensil. And then assuming no safety issues, that trial will continue to recruit another 100 patients. So this is a very significant trial in terms of data we expect it will generate of fitodensil in combination with azacitidine. And we're extremely happy do it with allg which is one of the leading research groups in this field worldwide with andrew y as the lead investigator so how does it add up to our strategy for the clinical pipeline i said the advanced to monotherapy trial is still a long-term follow-up so we will continue to monitor the progress of that trial the aml 22 cadence trial is starting and will generate initial data in 2025, and particularly those data will reflect the initial safety, which we can see in that first patient group treated. In parallel, we are preparing for a global registration trial, and that preparation phase will comprise two parts. It's on the one hand coming to a trial design and also interactions with the regulatory authorities that will allow us to come to a trial design that is also seen as the right one by the regulators. We are in regular interactions with both the FDA and EMA. So this part is the preparation phase we will do in-house. Then the other part is the manufacturing, and that is the project we are currently carrying out with Northex Biologics. Again, the facility is up and running. The preparation phase has been concluded, and we are now in the so-called tech transfer phase, which will take us into 2025. and which will release the first large-scale GMP batches hopefully mid-next year. So with that, I will come to the summary and outlook for 2024. Based on the positive data in the ADVANCE-II trial, we are moving forward to late-stage development of idudensal in AML. We have ethics committee approval allowing for the start of the AML22 cadence trial in collaboration with ALLG. We are, as part of the late-stage development strategy, building up a global network of clinical centers. We had already worked with 10 clinical centers in Europe for the ADVANCE-II trial. We have opened the IND in the U.S., allowing us to start trial activities in the U.S. And now also with ALLG, we're opening up a much broader network of clinical centers in Australia and New Zealand and a number of Asian countries. So an important addition to our global clinical trial network. The manufacturing alliance with Northex Biologics, is on track for large-scale manufacturing of VDDenCell for the clinical trial, the registration trial, but in the end also for commercial launch. And we are preparing for pivotal stage readiness based on the trial preparations and large-scale GMP manufacturing expected to be ready in 2025 second half. All developments are supported by a strong regulatory dossier around VDDenCell. And then for the other programs, we expect additional readouts from the Allison Phase 1 trial in ovarian cancer, including the primary analysis in the second half of this year. And we continue to pursue elixir denser as a program, which we want to bring back into the clinic in soft tissue sarcomas. With that, it's the end of my presentation, and we're open for Q&A.

If you wish to ask a question, please dial pound key 5 on your telephone keypad. To enter the queue, if you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Chien-Hun Lee from Pareto Securities. Please go ahead.

Hi, good afternoon. So a few questions from me. Could you elaborate a bit on the timeline of the cadence trials and how would the data be used in registrational trials? Would that be a mainly safety data next year? And does the pivotal trial need to wait for the results for Cadence? Thank you.