Q2 2026 Mendus AB Earnings Call

Speaker #1: Presentation. We will begin with a presentation from the company speakers. CEO Dr. Erik Munting, and CFO Lotta Ferm. Following the presentation, we will open up for questions.

Speaker #1: To ask a question, press *5 on your telephone to enter the queue. When it's your turn to speak, press *6 to unmute. I will now hand over to CEO Dr. Erik Munting.

Speaker #1: Please go ahead.

Speaker #2: Thank you, and welcome everybody on behalf of myself and Lotta.

Speaker #3: Hello everyone, nice to meet you.

Speaker #2: Thanks for joining the Mendes Financial and Business Update over the second quarter of 2026. It was a very busy quarter with, in which the clinical development gained a lot of momentum.

Speaker #2: We have reached the final stage of the advanced 2 trial, the long-term follow-up of that trial, is officially concluding when the last patient has reached the 5-year mark, and we're happy to disclose that that has happened.

Speaker #2: So it means also that the majority of patients has actually reached 5-year survival, and we're, of course, very happy with that outcome. The trial which is ongoing in Australia called AML 22 Cadence has picked up momentum and has now reached the 20-patient enrollment milestone that we were aiming for by mid of this year, allowing us for an initial readout.

Speaker #2: And we have finished preparations for the DIVA trial, which is combining our product with less intensive first-line treatment of AML, and that trial is ready to start subject to final ethics committee approval.

Speaker #1: The 5-year mark, and we're happy to disclose that that has happened. So it means also that the majority of patients has actually reached 5-year survival, and we're, of course, very happy with that outcome.

Speaker #2: We have decided to look into children's AML, and the reason is that we believe we have a good basis on our adult AML program, and the safety profile of the product also matches that setting, and so we have started preparing and particularly also with U.S.

Speaker #1: The trial, which is ongoing in Australia—called AML22 Cadence—has picked up momentum and has now reached the 20-patient enrollment milestone that we were aiming for by mid-year.

Speaker #2: clinical centers potential expansion toward the pediatric setting. We have started our CML program, and we have successfully enrolled the first stage of the phase 1 trial called Vital CML in patients with suboptimal responses.

Speaker #1: Allowing us for an initial readout. We have finished preparations for the DIVA trial, which is combining our product with less intensive first-line treatment of AML, and that trial is ready to start, subject to final Ethics Committee approval.

Speaker #2: Against current standard of care with TKIs, and that also allows us to do as planned a first readout in the second half of 2026.

Speaker #1: We have decided to look into children's AML, and the reason is that we believe we have a good basis with our adult AML program, and the safety profile of the product also matches that setting.

Speaker #2: Because we have made that progress, we have also initiated preparations for the Vital TFR 2 trial, which is a phase 2 trial in combination with SUMRI, which is a well-respected Australian research institute and this trial will be led by very prominent Australian researchers, so it will be subject to the initial readout from the Vital CML trial, but since we have so successfully recruited that first stage, we believe it was also good to already start the preparations for the TFR 2 trial so that we're in a position to start that trial later this year.

Speaker #1: And so we have started preparing—and particularly also with U.S. clinical centers—potential expansion toward the pediatric setting. We have started our CML program, and we have successfully enrolled the first stage of the Phase 1 trial called Vital-CML in patients with suboptimal responses.

Speaker #1: Against the current standard of care with TKIs. And that also allows us to do, as planned, a first readout in the second half of 2026.

Speaker #2: The clinical advisory board that has supported our clinical strategy is a group of very well-respected international experts, so we're very happy with the fact that they have supported us with expert advice on the updated clinical strategy, and also very importantly, recently there was an initiation of coverage by a U.S.

Speaker #1: Because we have made that progress, we have also initiated preparations for the Vital TFR2 trial, which is a Phase 2 trial in combination with SAMRI, which is a well-respected Australian research institute, and this trial will be led by very prominent Australian researchers.

Speaker #2: analyst from the investment bank Lucid Capital Market, which is a well-respected investment bank in the U.S., and this is of course an important step to increase our visibility toward U.S.

Speaker #1: So, it will be subject to the initial readout from the VITAL-CML trial, but since we have so successfully recruited that first stage, we believe it was also good to already start the preparations for the TFR2 trial so that we're in a position to start that trial later this year.

Speaker #2: investors. I would like to hand it over to Lotta for the summary of the financial situation.

Speaker #3: Yeah, hi everyone, and for the quarter, the cost level was 20.5 million compared to 24.1 million last year for the same period. The main reason for the lower cost is that we did we made a big reorganization last year, so we let go of personnel, so we are more slimmed down organization right now, and we focus on the clinical trials and to take them forward.

Speaker #1: The clinical advisory board that has supported our clinical strategy is a group of very well-respected international experts, so we're very happy with the fact that they have supported us with expert advice on the updated clinical strategy.

Speaker #1: And also, very importantly, recently there was an initiation of coverage by a U.S. analyst from the investment bank Lucid Capital Market, which is a well-respected investment bank in the U.S., and this is, of course, an important step to increase our visibility toward the U.S.

Speaker #3: The cash position at the end of the quarter was 59.9 million, and that will take us into the first quarter of 2027.

Speaker #1: Investors, I would like to hand it over to Lotta for the summary of the financial situation.

Speaker #2: Thanks for that. So the clinical pipeline in summary positions our product across first-line treatment in AML. In adult AML, that comprises the chemotherapy setting, but also the less intensive first-line setting which is called Vanase or Vanitoflex plus Azacitidine, but also like I said we have started preparations for pediatric program.

Speaker #2: Yes. Hi everyone, and for the quarter, the cost level was $20.5 million compared to $24.1 million last year for the same period. The main reason for the lower cost is that we made a big reorganization last year, so we let go of personnel, so we are a more slimmed-down organization right now.

Speaker #2: Those trials will guide us in the data that they produce toward the optimal path to market. Then in CML, as I mentioned, we have started preparing for two separate trials of which one is now ongoing, and the second trial will be starting subject to the initial positive safety readout of the phase 1 Vital CML trial.

Speaker #2: And we focus on the clinical trials and taking them forward. The cash position at the end of the quarter was €59.9 million, and that will take us into the first quarter of 2027.

Speaker #1: Thanks for that. So, the clinical pipeline in summary positions our product across first-line treatment in AML. In adult AML, that comprises the chemotherapy setting, but also the less intensive first-line setting, which is called VEN-AZA, or venetoclax plus azacitidine.

Speaker #2: So that program is now on track. Again, very happy that such imminent experts in the field from the U.S., from Australia, from Europe have joined our clinical advisory board and have been able to provide us with the advice that we needed to set out the clinical strategy that I just described.

Speaker #1: But also, like I said, we have started preparations for the pediatric program. Those trials will guide us, through the data they produce, toward the optimal path to market.

Speaker #2: And also, it's good to see that there is growing momentum in industry around AML and CML. In both diseases, as I will explain, there is still high medical need.

Speaker #1: Then in CML, as I mentioned, we have started preparing for two separate trials, of which one is now ongoing and the second trial will be starting, subject to the initial positive safety readout.

Speaker #2: AML is still largely unresolved disease with a very poor 5-year outcome, so the fact that there is now increasing activity in the form of financings, in the form of M&A or partnerships, in both areas, AML and CML, creates good momentum and we feel that we are uniquely positioned in that competitive landscape.

Speaker #1: Of the Phase 1 VITAL CML trial. So that program is now on track. Again, very happy that such eminent experts in the field from the U.S., from Australia, from Europe, have joined our clinical advisory board and have been able to provide us with the advice that we needed to set out the clinical strategy that I just described.

Speaker #2: And also very relevant, yesterday there was a major breakthrough in the development of cancer vaccines, and that validated one of the essential parts of our strategy that we have always advocated, which is that these kind of therapies whereby you train the immune system against cancer cells work best if you apply them in a setting where you want to prevent recurrence.

Speaker #1: And also, it's good to see that there is growing momentum in industry around AML and CML. In both diseases, as I will explain, there is still a high medical need.

Speaker #1: AML is still largely an unresolved disease with a very poor five-year outcome. So, the fact that there is now increasing activity in the form of financings, M&A, or partnerships in both areas—AML and CML—creates good momentum, and we feel that we are uniquely positioned in that competitive landscape.

Speaker #2: In this case, this was a vaccine, co-developed by Moderna and Merck, in solid tumors, but of course we have our own approach that specifically focuses on blood cancers.

Speaker #2: Now, what's the rationale to apply immunotherapy and specifically our lead product Vididencel in myeloid blood cancers? The unmet need is different in AML and CML, but the principle is the same: you want to train the immune system to have a durable control over residual cancer cells.

Speaker #1: And also very relevant, yesterday there was a major breakthrough in the development of cancer vaccines, and that validated one of the essential parts of our strategy that we have always advocated, which is that these kinds of therapies, whereby you train the immune system against cancer cells, work best if you apply them in a setting where you want to prevent recurrence.

Speaker #2: In AML, that mostly translates into survival, because the relapse rates in AML are high and relapse is almost always associated with death, in CML that's a different story, there is a group of drugs called tyrosine kinase inhibitors, or TKIs, that successfully suppresses the disease, but you have to take these drugs for the rest of your life.

Speaker #1: In this case, this was a vaccine co-developed by Moderna and Merck in solid tumors, but of course, we have our own approach that specifically focuses on blood cancers.

Speaker #2: And that is of course a big burden not only for the patient, for the adherents, the toxicity, and everything else that is associated with chronic drug use, but also for the healthcare system and the costs associated with that.

Speaker #1: Now, what's the rationale to apply immunotherapy, and specifically our lead product Vididencel, in myeloid blood cancers? The unmet need is different in AML and CML, but the principle is the same: you want to train the immune system to have a durable control over residual cancer cells.

Speaker #2: So the ultimate goal in the treatment of CML is considered treatment-free remission, where we create conditions in which patients can safely stop their TKIs without the risk of their disease coming back.

Speaker #1: In AML, that mostly translates into survival because the relapse rates in AML are high, and relapse is almost always associated with death. In CML, that's a different story.

Speaker #2: We know immunotherapy can be curative in these myeloid blood cancers, and the main reason for that is allogeneic stem cell transplant, or in the past it was also called bone marrow transplant.

Speaker #1: There is a group of drugs called tyrosine kinase inhibitors, or TKIs, that successfully suppress the disease. But you have to take these drugs for the rest of your life.

Speaker #2: It's specifically relates to a mismatch between the immune system and the cancer cells, so only the allogeneic stem cell transplants are curative, so they have to come from a donor immune system, but as you can imagine, transplant a foreign immune system in the body has a lot of side effects.

Speaker #1: And that is, of course, a big burden not only for the patient—for the adherence, the toxicity, and everything else that is associated with chronic drug use—but also for the healthcare system and the costs associated with that.

Speaker #1: So the ultimate goal in the treatment of CML is considered treatment-free remission, where we create conditions in which patients can safely stop their TKIs without the risk of their disease coming back.

Speaker #2: Actually, there's around 20% transplant-related mortality and also there are significant morbidity, particularly related to a phenomenon called GRAF versus host disease, where the new immune system actually also attacks the healthy tissues in the body.

Speaker #1: We know immunotherapy can be curative in these myeloid blood cancers, and the main reason for that is allogeneic stem cell transplant, or in the past, it was also called bone marrow transplant.

Speaker #2: But we know that the so-called GRAF versus leukemia effect is curative, both in AML and CML. Other immunotherapies have not been very successful. So interferon, which is an immune modulator, is a very complicated drug and has not delivered consistent success, and immune checkpoint inhibitors that have been very successful across solid tumors do not work and have not delivered clinical benefit in myeloid blood cancers.

Speaker #1: It specifically relates to a mismatch between the immune system and the cancer cells, so only the allogeneic stem cell transplants are curative; they have to come from a donor immune system.

Speaker #1: But as you can imagine, transplanting a foreign immune system into the body has a lot of side effects. Actually, there is around 20% transplant-related mortality, and also there is significant morbidity, particularly related to a phenomenon called graft-versus-host disease, where the new immune system actually also attacks the healthy tissues in the body.

Speaker #2: So this leaves for us a unique positioning to address the prevention of recurrence and to establish long-term durable remissions of disease with a product that is safe.

Speaker #2: So one of the key elements of our product is that it has a good safety profile, so we can apply it across these myeloid blood cancers when the disease burden is low and when the initial treatment has been successful.

Speaker #1: But we know that the so-called graft-versus-leukemia effect is curative, both in AML and CML. Other immunotherapies have not been very successful. Interferon, which is an immune modulator, is a very complicated drug and has not delivered consistent success.

Speaker #2: So that defines our positioning. In AML, as I mentioned, the main focus is to prevent recurrence, so the positioning of the product is when first-line treatment has successfully accomplished a remission.

Speaker #1: And immune checkpoint inhibitors, that have been very successful across solid tumors, do not work and have not delivered clinical benefit in myeloid blood cancer.

Speaker #2: And this is where the residual cancer cells can cause a recurrence or a relapse. And of course you can't continue to treat small levels of disease with very toxic therapy, so this is why we want to train the immune system to help control disease over a longer periods of time.

Speaker #1: So this leaves us with a unique positioning to address the prevention of recurrence and to establish long-term, durable remissions of disease with a product that is safe.

Speaker #1: So, one of the key elements of our product is that it has a good safety profile, so we can apply it across these myeloid blood cancers when the disease burden is low and when the initial treatment has been successful.

Speaker #2: The advanced two trial is the trial that we started in this setting, and we started in patients that had levels of disease that were detectable, so this is called measurable residual disease.

Speaker #1: So that defines our positioning. In AML, as I mentioned, the main focus is to prevent recurrence. So the positioning of the product is when first-line treatment has successfully accomplished a remission.

Speaker #2: These patients have a relatively poor prognosis because of the presence of disease and also in this specific setting, patients were not scheduled for transplant for different reasons, sometimes there was no donor, sometimes patients were not fit enough to undergo transplant.

Speaker #1: And this is where the residual cancer cells can cause a recurrence or a relapse. And of course, you can't continue to treat small levels of disease, which is why we want to train the immune system to help control disease over longer periods of time.

Speaker #2: So this was an alternative to see if we could accomplish, first of all, a potential effect on the MRD, which we documented early on in the trial, we also showed that the immune response was triggered by the product were associated with these MRD responses, but of course very importantly, we started to see what we were looking for, which is durable survival benefit.

Speaker #1: The ADVANCE II trial is the trial that we started in this setting, and we started in patients who had levels of disease that were detectable.

Speaker #2: So the majority of patients in this trial, it was 20 patients that entered the trial, 14 of those patients became long-term survivors and 13 patients are still alive today, and as I mentioned, the last patient that was still in long-term follow-up has passed the five-year mark, so we are now going to close this trial, but we are of course very happy with this outcome.

Speaker #1: So this is called measurable residual disease. These patients have a relatively poor prognosis because of the presence of disease, and also, in this specific setting, patients were not scheduled for transplant for different reasons.

Speaker #1: Sometimes there was no donor, and sometimes patients were not fit enough to undergo transplant. So, this was an alternative to see if we could accomplish, first of all, a potential effect on the MRD, which we documented early on in the trial.

Speaker #2: Which we also see as validating for the concept that we're after, which is to train the immune system to control residual disease, leading to durable survival benefits.

Speaker #2: Now, how are we going to take this program forward? We are currently positioned in the chemotherapy setting or the high-intensity chemotherapy setting, so AML patients that have a relatively good fitness are eligible for high-intensity chemotherapy, and after that, they either get a transplant or they are in a very high risk of relapse.

Speaker #1: We also showed that the immune responses triggered by the product were associated with these MRD responses. But of course, very importantly, we started to see what we were looking for, which is a durable survival benefit.

Speaker #1: So, the majority of patients in this trial—it was 20 patients that entered the trial—14 of those patients became long-term survivors, and 13 patients are still alive today.

Speaker #2: Again, we treated patients that were not scheduled for transplant for different reasons, and that is the setting that we continue to work in with two trials, the advanced two trial that we are now going to close and the cadence trial, which is ongoing in Australia.

Speaker #1: And as I mentioned, the last patient that was still in long-term follow-up has passed the five-year mark, so we are now going to close this trial.

Speaker #1: We are, of course, very happy with this outcome, which we also see as validating for the concept that we're after: to train the immune system to control residual disease, leading to durable survival benefits.

Speaker #2: The other interesting part is that the effect of first-line treatment for those patients that are deemed not fit for chemotherapy has tremendously improved due to a new drug called venetoclax.

Speaker #1: Now, how are we going to take this program forward? We are currently positioned in the chemotherapy setting, or the high-intensity chemotherapy setting. So AML patients that have a relatively good fitness are eligible for high-intensity chemotherapy.

Speaker #2: And venetoclax is dramatically changing the AML landscape, it has led to much more successful complete remissions in patients unfit for chemotherapy, but also more and more clinical data come to the surface demonstrating that actually also for fit patients the treatment with venetoclax combined with azacitidine could be beneficial because it results in better event-free survival in the first year, it results in less hospitalizations, less infections, but still the overall survival or the long-term survival will be dependent on treatments that are basically effective after the first complete remission has been accomplished.

Speaker #1: And after that, they either get a transplant or they are at a very high risk of relapse. Again, we treated patients who were not scheduled for transplant for different reasons.

Speaker #1: And that is the setting that we continue to work in, with two trials: the ADVANCE II trial, that we are now going to close, and the CADENCE trial, which is ongoing in Australia.

Speaker #1: The other interesting part is that the effect of first-line treatment for those patients who are deemed not fit for chemotherapy has tremendously improved due to a new drug called venetoclax.

Speaker #2: So that's why we also want to combine with this specific combination of venetoclax and azacitidine so that we can capture the broader first-line setting in AML.

Speaker #1: And venetoclax is dramatically changing the AML landscape. It has led to much more successful complete remissions in patients unfit for chemotherapy, but also more and more clinical data come to the surface demonstrating that actually, also for fit patients, the treatment with venetoclax combined with azacitidine could be beneficial because it results in better event-free survival in the first year.

Speaker #2: The cadence trial is ongoing in Australia and the principal investigator is one of the world-leading KOLs called Andrew Wei, this trial is now recruited the first 20 patients, the trial is designed actually as a first 40 patients safety trial, and then with the possibility to expand it into a larger trial up to 100 patients, we have now achieved the first 20 patient enrollment and there were no product-related serious adverse events.

Speaker #1: It results in fewer hospitalizations and fewer infections. But still, the overall survival, or the long-term survival, will be dependent on treatments that are basically effective after the first complete remission has been accomplished.

Speaker #2: So this is a very important initial outcome that also if we combine our product with oral azacitidine it still maintains its very strong safety profile.

Speaker #1: So that's why we also want to combine with this specific combination of venetoclax and azacitidine, so that we can capture the broader first-line setting in AML.

Speaker #2: And of course now also we have collected samples during the trial, so we can start looking into correlative studies that for example look into the immune system, look at the levels of residual disease, and this is a setting that we will further investigate and that will add to the data package that we have accumulated from the advanced two trial.

Speaker #1: The Cadence trial is ongoing in Australia, and the principal investigator is one of the world-leading KOLs, Andrew Wei. This trial has now recruited the first 20 patients.

Speaker #1: The trial is designed, actually, as a first 40-patient safety trial, and then with the possibility to expand it into a larger trial, up to 100 patients.

Speaker #2: Now then going to the other setting, the venetoclax plus azacitidine setting, this is a trial called DIVA that we have now prepared, we are awaiting final sign-off of the ethics committee approval and then we can start the trial in the third quarter of 2026 based on the assumption that there will be a positive decision by the ethics committee.

Speaker #1: We have now achieved the first 20 patient enrollment, and there were no product-related serious adverse events. So this is a very important initial outcome, but also, if we combine our product with oral azacitidine, it still maintains its very strong safety profile.

Speaker #2: And that is a very significant trial because it will significantly broaden the positioning of the product in the first-line treatment landscape of AML. So we hope to announce the start of this trial soon, then we are ready to engage in it.

Speaker #1: And, of course, now also we have collected samples during the trial, so we can start looking into correlative studies that, for example, look into the immune system, look at the levels of residual disease. And this is a setting that we will further investigate, and that will add to the data package that we have accumulated from the ADVANCE II trial.

Speaker #2: For the pediatric program, we have thought through how we can use the data that we have collected in the adult trials and specifically of course the long-term survival benefit combined with a strong safety profile to see if this can be a benefit for children diagnosed with AML.

Speaker #1: Now, then going to the other setting, the venetoclax plus azacitidine setting, this is a trial called DIVA that we have now prepared. We are awaiting final sign-off of the ethics committee approval, and then we can start the trial in the third quarter of 2026, based on the assumption that there will be a positive decision by the ethics committee.

Speaker #2: This will also be an expansion towards the US, so the trials that we are now preparing for will both be in the US with one trial potentially also expanding into Europe, and they will focus first on the second complete remission setting, so where children have had a relapse but have successfully been brought into remission a second time, and we are also planning for a trial in the first complete remission setting which will be very similar to the setting that we have tested in adult AML in the cadence trial and in the advanced two trial.

Speaker #1: And that is a very significant trial because it will significantly broaden the positioning of the product in the first-line treatment landscape of AML. So we hope to announce the start of this trial soon.

Speaker #1: Then we are ready to engage in it. For the pediatric program, we have thought through how we can use the data that we have collected in the adult trials, and specifically, of course, the long-term survival benefit combined with a strong safety profile.

Speaker #2: So this adds up to a pipeline that will deliver multiple milestones, very importantly the DIVA trial when it starts will we expect recruit relatively quickly and will allow us for an initial readout in the first quarter of next year and then an initial readout on all 24 patients that we plan to enroll in this trial in the third quarter of next year.

Speaker #1: To see if this can be of benefit for children diagnosed with AML. This will also be an expansion towards the US. So the trials that we are now preparing for will both be in the US, with one trial potentially also expanding into Europe. They will focus first on the second complete remission setting, so where children have had a relapse but have successfully been brought into remission a second time.

Speaker #2: So this will be an important validating step to show that we can combine our product safely and effectively with venetoclax plus azacitidine. This trial, because it's the first time we administer the product in this setting, will be focusing on MRD positive patients because that will also allow us to pick up the initial safety signals or sorry, the initial efficacy signals based on potential changes in the MRD levels.

Speaker #1: And we are also planning for a trial in the first complete remission setting, which will be very similar to the setting that we have tested in adult AML in the CADENCE trial and in the ADVANCE II trial.

Speaker #1: So this adds up to a pipeline that will deliver multiple milestones. Very importantly, the DIVA trial, when it starts, we expect will recruit relatively quickly and will allow us an initial readout in the first quarter of next year, and then an initial readout on all 24 patients that we plan to enroll in this trial in the third quarter of next year.

Speaker #2: Then the pediatric trial, as I explained, is in preparation and we hope to start that program in the first half of next year and basically address second-line first and then the first-line setting as a next step in potentially expanding our product towards pediatric AML.

Speaker #1: So this will be an important validating step to show that we can combine our product safely and effectively with venetoclax plus azacitidine. This trial, because it's the first time we administer the product in this setting, will be focusing on MRD-positive patients because that will also allow us to pick up the initial safety signals—or, sorry, the initial efficacy signals—based on potential changes in the MRD levels.

Speaker #2: In CML, the numbers are a lot bigger than in AML when we talk about the patients affected by CML. Patients with CML are now well under control with tyrosine kinase inhibitors, the disease is well under control with tyrosine kinase inhibitors.

Speaker #2: But as I explained, the real challenge now is to see if we can find conditions to allow more patients to stop their TKI. So in the past, CML was very deadly disease like AML and the only curative approach was allogeneic stem cell transplant.

Speaker #1: And then the pediatric trial, as I explained, is in preparation, and we hope to start that program in the first half of next year. We will basically address second-line first, and then the first-line setting as a next step in potentially expanding our product towards pediatric AML.

Speaker #2: Today we have a growing number of TKIs and actually also there has been quite some innovation recently in finding stronger binding and more specific TKIs to suppress the disease, but the future again is to see if we can find conditions to allow more patients to stop with chronic use of therapy.

Speaker #1: In CML, the numbers are a lot bigger than in AML when we talk about the patients affected by CML. Patients with CML are now well under control with tyrosine kinase inhibitors.

Speaker #2: The two main hurdles to accomplish that goal are first of all, according to the guidelines, only patients with what's called a deep molecular response, so with an optimal response to TKI over multiple years are eligible to try and stop their TKIs.

Speaker #1: The disease is well under control with tyrosine kinase inhibitors. But, as I explained, the real challenge now is to see if we can find conditions to allow more patients to stop their TKI.

Speaker #2: Now this is a setting that for most patients is not accomplished because they simply never reach these optimal responses to TKI, so they will never become TFR eligible.

Speaker #1: So, in the past, CML was a very deadly disease, like AML, and the only curative approach was allogeneic stem cell transplant. Today, we have a growing number of TKIs, and actually, there has also been quite some innovation recently in finding stronger binding and more specific TKIs to suppress the disease.

Speaker #2: The second big hurdle in CML is once patients are TFR eligible and they can stop their TKIs, actually in half of the patients the disease shows rising levels already in the first six months and then patients can be safely put back on their original TKI or a next TKI.

Speaker #1: But the future, again, is to see if we can find conditions to allow more patients to stop with chronic use of therapy. The two main hurdles to accomplish that goal are, first of all, according to the guidelines, only patients with what's called a deep molecular response—so, with an optimal response to TKI over multiple years—are eligible to try and stop their TKIs.

Speaker #2: But of course that is a TFR failure and patients again have to see if they can find conditions under which they can stop their TKIs.

Speaker #2: Now this is a setting where we believe the training of the immune system may allow more patients to experience a successful TFR. The trial which is now ongoing is called Vital CML, it's a phase one trial in Bergen, Norway under the watch of Professor Bjørn Gjertsen.

Speaker #1: Now, this is a setting that for most patients is not accomplished because they simply never reach these optimal responses to TKI, so they will never become TFR eligible.

Speaker #2: And we're very happy with his dedication, he was also one of the largest contributors to our AML trial that I just discussed the advanced two trial.

Speaker #1: The second big hurdle in CML is, once patients are TFR-eligible and they can stop their TKIs, actually in half of the patients, the disease shows rising levels already in the first six months, and then patients can be safely put back on their original TKI or a next TKI.

Speaker #2: But also of course we're very grateful to the patients in his clinic that have participated in this trial and allowed us to recruit the first eight patients, safety tolerability stage of the trial, so efficiently before the summer which will allow us to have an initial readout after the summer.

Speaker #1: But of course, that is a TFR failure, and patients, again, have to see if they can find conditions under which they can stop their TKIs.

Speaker #2: And the trial is continuing to recruit. We are now at 10 patients and we expect that this trial will continue to recruit up to 24 patients and that will also of course lead to a next readout in the middle of next year for all of the patients that we treated in this trial.

Speaker #1: Now, this is a setting where we believe training the immune system may allow more patients to experience a successful TFR. The trial, which is now ongoing, is called VITAL CML.

Speaker #1: It's a phase one trial in Bergen, Norway, under the watch of Professor Bjørn Gjertsen, and we're very happy with his dedication. He was also one of the largest contributors to our AML trial that I just discussed, the ADVANCE II trial.

Speaker #2: Very importantly, the initial eight patients safety tolerability data are also supporting the start of the Vital TFR two trial which is a trial that we will do in Australia with one of the world leading KOLs specifically focused on TFR, Professor called Timothy Hughes.

Speaker #1: But also, of course, we're very grateful to the patients in his clinic that have participated in this trial and allowed us to recruit the first eight patients—safety, tolerability stage of the trial—so efficiently before the summer, which will allow us to have an initial readout after the summer.

Speaker #2: And that is a trial that will be in the south of Australia and Adelaide with multiple centers involved. But the start of the trial is subject to a successful initial safety readout of the Vital CML trial.

Speaker #1: And the trial is continuing to recruit. We are now at 10 patients, and we expect that this trial will continue to recruit up to 24 patients.

Speaker #2: Both trials will continue to deliver data and specifically mid-next year we expect to have data from both trials that will validate the positioning of idioden cell in CML and in both patient populations so both the patients that have a suboptimal response to TKIs where we can help more patients accomplish those deep molecular responses that we are looking for.

Speaker #1: And that will also, of course, lead to a next readout in the middle of next year for all of the patients that we treated in this trial.

Speaker #1: But very importantly, the initial eight patients' safety and tolerability data are also supporting the start of the VITAL-TFR-2 trial, which is a trial that we will do in Australia with one of the world's leading KOLs, specifically focused on TFR, Professor Cole Timothy Hughes.

Speaker #2: And secondly, the patients that have accomplished a successful deep molecular response but that of course once they stop their TKIs want to see better outcomes of their TFR attempt.

Speaker #2: The reason this trial is called TFR two is that the TFR failure rates due to relapse are even higher in the second setting. So when patients had an earlier failed TFR attempt the relapse rates are generally higher in the second TFR attempt.

Speaker #1: And that is a trial that will be in the south of Australia, in Adelaide, with multiple centers involved. But the start of the trial is subject to a successful initial safety readout of the VITAL CML trial.

Speaker #1: Both trials will continue to deliver data, and specifically, by mid-next year, we expect to have data from both trials that will validate the positioning of Iridan cell in CML and in both patient populations: both the patients that have a suboptimal response to TKIs, where we can help more patients accomplish those deep molecular responses that we are looking for, and secondly, the patients that have accomplished a successful deep molecular response but that, of course, once they stop their TKIs, want to see better outcomes of their TFR attempt.

Speaker #2: So this is a patient population we feel that will benefit most from our therapy but of course also as a first step towards the broader TFR setting.

Speaker #2: With the momentum we have now created in the clinical pipeline we expect a steady cadence of readouts for the next 6 to 12 months and that will validate not only the positioning of idioden cell in AML but also the expanding positioning in AML to include the less intensive first-line treatment and of course the expansion of this program towards CML with an active CML program focusing on both the suboptimal responders and the actual TFR challenge that we want to address in that setting.

Speaker #1: The reason this trial is called TFR2 is that the TFR failure rates due to relapse are even higher in the second setting. So when patients have had an earlier failed TFR attempt, the relapse rates are generally higher in the second TFR attempt.

Speaker #1: So, this is a patient population we feel will benefit most from our therapy—but of course, it's also a first step towards the broader TFR setting.

Speaker #2: The ambition of the company is to continue to grow both with trials but also with our international presence. We have established a network of centers and collaborators across the world.

Speaker #1: With the momentum we have now created in the clinical pipeline, we expect a steady cadence of readouts for the next 6 to 12 months, and that will validate not only the positioning of Iridan cell in AML, but also the expanding positioning in AML to include the less intensive first-line treatment and, of course, the expansion of this program towards CML with an active CML program focusing on both the suboptimal responders and the actual TFR challenge that we want to address in that setting.

Speaker #2: Our trials have always been in multiple centers throughout Europe and now also of course in Australia but now also we have a clear plan to expand towards the US and of course we're also very happy that the visibility of what we are doing is picked up more and more both by the clinical community and now also with the US analyst coverage that will expose us much more to US investors.

Speaker #2: So with that I would like to thank you for your attention and open this session for Q&A.

Speaker #1: The ambition of the company is to continue to grow, both with trials and also with our international presence. We have established a network of centers and collaborators across the world.

Speaker #1: We will now open up for questions. To ask a question, press star five on your telephone to enter the queue. When it's your turn to speak, press star six to unmute your microphone.

Speaker #1: The first question comes from Shen Sunli at Pareto Securities. Please go ahead.

Speaker #1: Our trials have always been in multiple centers throughout Europe and now, of course, also in Australia. But now, we also have a clear plan to expand towards the US, and of course, we're also very happy that the visibility of what we are doing is being picked up more and more, both by the clinical community and now also with the US analyst coverage that will expose us much more to US investors.

Speaker #2: We can't hear you yet. Yeah now we can hear you. Yep.

Speaker #3: Can you hear me? Oh yeah, sorry. Not so familiar with the new system. Yeah, thanks for the update. So a quick question from me.

Speaker #3: So regarding the cadence trial for the initial readout, what would you consider as the meaningful apart from safety and also is the trial still tracking towards the larger 100 patients?

Speaker #1: So with that, I would like to thank you for your attention and open this session for Q&A. We will now open up for questions.

Speaker #1: To ask a question, press star five on your telephone to enter the queue. When it's your turn to speak, press star six to unmute your microphone.

Speaker #3: If you can see stage and will that stage be separated, funded, or is it contingent on this readout? Thank you.

Speaker #1: The first question comes from Shen Sunli at Pareto Securities. Please go ahead.

Speaker #2: Thanks for joining, Jen, and thanks for your question. So let me take it in two parts. First of all, when you're in early stage of a trial, what you want to see is initial signs of efficacy and as you may remember also from the advanced two trial, one of the first things you start looking for is whether the immune system responds to the treatment and of course you want to see if you can correlate that to outcomes that are indicative of efficacy.

Speaker #2: We can't hear you yet.

Speaker #1: Oh.

Speaker #2: Yeah, now we can hear you.

Speaker #3: Can you hear me?

Speaker #2: Yep.

Speaker #3: Oh, yeah. Sorry, I'm not so familiar with the new system. Yeah, thanks for the update. So, a quick question from me. Regarding the CADENCE trial, for the initial readout, what would you consider as meaningful, apart from safety?

Speaker #2: Initially you can't link that to the long-term survival that we have now brought to the surface in the advanced two trial. So we'll look for MRD responses for example which means that the levels of disease may be varying.

Speaker #3: And also, is the trial still tracking towards the larger 100 patients? If you can see stage, and will that stage be separated, funded, or is it contingent on this readout?

Speaker #2: The technical part that is important to remember is that this trial is not focusing on MRD positive patients. So the advanced two trial was specifically focused on MRD positive patients this trial incorporates the broader patient population independent of MRD.

Speaker #3: Thank you.

Speaker #2: Thanks for joining, Chen, and thanks for your question. So, let me take it in two parts. First of all, when you're in the early stage of a trial, what you want to see is initial signs of efficacy. And, as you may remember also from the Advanced II trial, one of the first things you start looking for is whether the immune system responds to the treatment.

Speaker #2: And the reason is that that's the end goal that we have in mind. And also MRD negative patients do have residual cancer cells. So it's not that because you can't detect them they are not there.

Speaker #2: So we don't want to exclude or on a positive basis include only MRD positive patients. And also the insights in what actually defines MRD and also meaningful MRD has shifted dramatically in the last years.

Speaker #2: And of course, you want to see if you can correlate that to outcomes that are indicative of efficacy. Initially, you can't link that to the long-term survival that we have now brought to the surface in the ADVANCED II trial.

Speaker #2: So we'll look for MRD responses, for example, which means that the levels of disease may be varying. The technical part that is important to remember is that this trial is not focusing on MRD-positive patients.

Speaker #2: So our molecular methods to measure MRD and specifically also mutations associated with AML that for example can be treated with specific targeted compounds has been there's been an immense evolution in let's say our understanding of MRD and also the way MRD is used in clinical practice.

Speaker #2: So the ADVANCE II trial was specifically focused on MRD-positive patients. This trial incorporates the broader patient population, independent of MRD. And the reason is that that's the end goal that we have in mind.

Speaker #2: So instead of looking just at MRD positive patients and seeing if they can turn MRD negative, which was the start of the advanced two trial, we are first of all now not excluding patients that don't have a formal MRD positive status and we look much more longitudinally for what happens with their MRD levels which can go up and down.

Speaker #2: And also, MRD-negative patients do have residual cancer cells. So, it's not that because you can't detect them, they are not there. So, we don't want to exclude, or, on a positive basis, include only MRD-positive patients.

Speaker #2: And also, the insights in what actually defines MRD and also meaningful MRD has shifted dramatically in the last years. So our molecular methods to measure MRD and specifically also mutations associated with AML that, for example, can be treated with specific targeted compounds has been there's been an immense evolution in, let's say, our understanding of MRD and also the way MRD is used in clinical practice.

Speaker #2: So it's not going to be such a black and white signal as we saw initially in the advanced two trial but we're certainly trying to get as much correlative data already early out of the trial to establish what's going on.

Speaker #2: Of course with the confidence level that we have from the advanced two trial but also to be realistic this will be adding insights on top of the data we have accomplished from the advanced two trial including of course the long-term follow-up of the advanced two trial.

Speaker #2: Then with respect to the path forward, the reason we want to keep optionality is that the first-line treatment landscape is changing so quickly. So where if we need to collect is now becoming more and more successful in the patients not eligible for high-intensity chemotherapy there's now all also more and more data showing that it may also be beneficial for the patients that are chemo-eligible.

Speaker #2: So, instead of looking just at MRD-positive patients and seeing if they can turn MRD-negative—which was the start of the ADVANCE II trial—we are, first of all, now not excluding patients that don't have a formal MRD-positive status.

Speaker #2: And we look much more longitudinally for what happens with their MRD levels, which can go up and down. So it's not going to be such a black-and-white signal as we saw initially in the ADVANCE II trial.

Speaker #2: So first of all we need to make sure that the product can be combined with when need to collect because that will enormously expand our addressable patient population but also when you think through what could be registration trial scenarios you have to keep this in mind.

Speaker #2: But we're certainly trying to get as much correlative data already early out of the trial to establish what's going on. Of course, with the confidence level that we have from the ADVANCE II trial, but also, to be realistic, this will be adding insights on top of the data we have accomplished from the ADVANCE II trial, including, of course, the long-term follow-up of the ADVANCE II trial.

Speaker #2: So in other words the cadence trial can be scaled up and it can be even beyond the 100 patients that we have now planned for into a potential registration trial or as part of a registration trial.

Speaker #2: Then with respect to the path forward, the reason we want to keep optionality is that the first-line treatment landscape is changing so quickly. So where if we need to collect is now becoming more and more successful in the patients not eligible for high-intensity chemotherapy, there's now all also more and more data showing that it may also be beneficial for the patients that are chemo-eligible.

Speaker #2: We have also to remind everybody of that had a successful end of phase two meeting with the FDA based on the advanced two trial.

Speaker #2: We have successfully established large-scale manufacturing and our manufacturing alliance with NorthX. So in principle this setting could be pushed into a registration trial but we thought it wiser as a tactical decision to first make sure we can combine with a need to collect and then also at the same time keep a close eye on how the first-line treatment landscape in AML will evolve because it could well be that Sunita collects becomes so dominant that the path to market is more optimal if we combine with a need to collect.

Speaker #2: So, first of all, we need to make sure that the product can be combined with who need to collect, because that will enormously expand our addressable patient population.

Speaker #2: But also, when you think through what could be registration trial scenarios, you have to keep this in mind. So, in other words, the CADENCE trial can be scaled up, and it can be even beyond the 100 patients that we have now planned for, into a potential registration trial or as part of a registration trial.

Speaker #2: And there may even be an option that first-line treatment becomes a lot more granular that we no longer separate patients black and white into chemo-eligible and chemo-ineligible but that there will be much more interchangeability between first-line treatment with high-intensity chemotherapy which has been around for now 40, 50 years and is still very effective.

Speaker #2: We also have to remind everybody that we had a successful end-of-Phase II meeting with the FDA, based on the advanced Phase II trial.

Speaker #2: We have successfully established large-scale manufacturing and our manufacturing alliance with NorthX. So in principle, this setting could be pushed into a registration trial. But we thought it wiser, as a tactical decision, to first make sure we can combine with who need to collect and then also, at the same time, keep a close eye on how the first-line treatment landscape in AML will evolve, because it could well be that who need to collect becomes so dominant that the path to market is more optimal if we combine with who need to collect.

Speaker #2: And if we need to collect may be becoming a much more dominant treatment. So we want to just be in a position to be able to combine with both settings, Jen, and on the basis of that design an optimal path to market.

Speaker #3: Okay. Yeah, that's clear. Thanks for taking my questions.

Speaker #2: With pleasure.

Speaker #1: The next question comes from Richard Ramonius at the Red Eye. Please go ahead.

Speaker #2: And there may even be an option that first-line treatment becomes a lot more granular, that we no longer separate patients, black and white, into chemo-eligible and chemo-ineligible.

Speaker #2: I think everybody is still getting used to the new system, Robert.

Speaker #2: But that there will be much more interchangeability between first-line treatment with high-intensity chemotherapy, which has been around for now 40 to 50 years, and is still very effective.

Speaker #1: Hello, good.

Speaker #3: Yeah. Yes. Yes, I'm ready. So my first question was about your increasing activity in the US how do you find the interest among investors in the US and in general in the pharma community for specifically CML?

Speaker #2: And who needs to collect may be becoming a much more dominant treatment. So we want to just be in a position to be able to combine with both settings, Chen, and on the basis of that, design an optimal path to market.

Speaker #3: OK, yeah, that's clear. Thanks for taking my question.

Speaker #2: With pleasure.

Speaker #1: The next question comes from Richard Ramonez at Red Eye. Please go ahead.

Speaker #2: Well, thanks Richard. I think you more or less implied the answer in your question. But let me start with the more general remark. In the US there is still the most advanced specialist investors that take part in biotech financings and also the bigger pockets of money.

Speaker #2: I think everybody is still getting used to the new system, Robert.

Speaker #1: Richard, yeah.

Speaker #2: Yes, yes, I'm ready. Yes. So my first question was about your increasing activity in the US. How do you find the interest among investors in the US, and in general in the pharma community, specifically for CML?

Speaker #2: So at a certain point in time it becomes logical to shift focus towards the US without losing your European and in our case also Nordic investor bases.

Speaker #2: Yeah, we will always be mindful of all of our investors. But if you move to a situation where you expand your clinical pipeline like we are now doing it's you have to be there.

Speaker #2: It's impossible to not be there. Right? But we also of course needed a basis to go there and until now we had a very successful recruitment of our trials in Europe we have a very cash efficient way of doing our trials in Australia also because we set up a daughter company in Australia called Mendis Australia that benefits from tax reductions that you get in Australia and that are actually paid back even if you're not yet a profitable company.

Speaker #3: Well, thanks, Richard. I think you more or less implied the answer in your question. But let me start with a more general remark. In the US, there are still the most advanced specialist investors that take part in biotech financings, and also the bigger pockets of money.

Speaker #3: So, at a certain point in time, it becomes logical to shift focus towards the US without losing your European and, in our case, also Nordic investor bases.

Speaker #2: But if you now want to step up the clinical efforts the way we want to do it you need deeper pockets of money. So we need to be in front of US investors of course what helped and this is coincidental we had been planning for our CML program already for multiple years.

Speaker #3: Yeah, we will always be mindful of all of our investors. But if you move to a situation where you expand your clinical pipeline, like we are now doing, you have to be there.

Speaker #2: We had already present preclinical data so the plan has been shaping up. But what was a specific trigger for more investors and specifically US investors to look into CML was that there was a big takeover in the beginning of this year of a company called Turns which has been acquired for $6.7 billion by Merck.

Speaker #3: It's impossible to not be there, right? But we also, of course, needed a basis to go there, and until now, we have had a very successful recruitment for our trials in Europe.

Speaker #3: We have a very cash-efficient way of doing our trials in Australia, also because we set up a daughter company in Australia called Mendus Australia that benefits from tax reductions you get in Australia, and that are actually paid back even if you're not yet a profitable company.

Speaker #2: The leading company in CML is still Novartis and Novartis has also launched a next-generation TKI called Scamlix for which they have predicted $4 billion of peak sales.

Speaker #2: So Turns who also has a similar compound was seen as a potential competitor and now Merck of course is into the game after they acquired Turns and then there was also another company called Enliven that did also a discovery of a new TKI and raised a lot of money in the US.

Speaker #3: But if you now want to step up the clinical efforts the way we want to do it, you need deeper pockets of money. So, we need to be in front of US investors.

Speaker #3: Of course, what helped—and this is coincidental—is that we had been planning for our CML program already for multiple years. We had already presented preclinical data.

Speaker #2: So I think the playground for CML has changed dramatically. It's been for a long time seen as a field with very little innovation and where nothing was happening and all patients were under control.

Speaker #3: So the plan has been shaping up. But what was a specific trigger for more investors, and specifically US investors, to look into CML was that there was a big takeover at the beginning of this year of a company called Turns, which was acquired for $6.7 billion by Merck.

Speaker #2: And first of all that is not the case. So when you actually talk to doctors and talk to patients you find out that the statistics are very different from the daily experience.

Speaker #3: The leading company in CML is still Novartis. And Novartis has also launched a next-generation TKI called Scemblix, for which they have predicted $4 billion of peak sales.

Speaker #2: And that adherence and lifelong treatment with all the side effects and also for younger patients really having heavy impact on their lives including not being able to raise a family for example is much more impactful than what you would see from clinical outcomes.

Speaker #3: So Turns, who also has a similar compound, was seen as a potential competitor. And now Merck, of course, is in the game after they acquired Turns.

Speaker #2: So I think it's very good that there's now a renewed interest for innovation in CML. And yeah, I think we have a nice positioning because the next thing after these more improved TKIs will be increasing focus on TFR.

Speaker #3: And then there was also another company called Enliven that also did a discovery of a new TKI and raised a lot of money in the US.

Speaker #3: So I think the playground for CML has changed dramatically. It's been for a long time seen as a field with very little innovation and where nothing was happening and all patients were under control.

Speaker #2: So that's the more general answer I can give you Richard. I can of course not comment on how individual investors perceive our story but I just can tell you that there's growing interest in the field and therefore also growing interest in us.

Speaker #3: And first of all, that is not the case. So, when you actually talk to doctors and talk to patients, you find out that the statistics are very different from the daily experience.

Speaker #2: And of course we're very happy that we now also have more direct visibility towards US investors because of the analyst coverage that has started.

Speaker #3: And that adherence and lifelong treatment, with all the side effects, also for younger patients, really has a heavy impact on their lives—including not being able to raise a family, for example—which is much more impactful than what you would see from clinical outcomes.

Speaker #3: No, that's a great answer. I'm satisfied. Just one last quick question. The who funds the vital TFR2 study?

Speaker #3: So I think it's very good that there's now a renewed interest in innovation in CML. And yeah, I think we have a nice positioning, because the next thing after these more improved TKIs will be an increased focus on TFR.

Speaker #2: That will be an investigator-sponsored trial but it will be to a large extent also sponsored by us. I think you understand the principle the vital CML trial is now ongoing as a corporate sponsored trial.

Speaker #3: So that's the more general answer I can give you, Richard. I can, of course, not comment on how individual investors perceive our story, but I can just tell you that there's growing interest in the field and, therefore, also growing interest in us.

Speaker #2: So we are formally the sponsor. The setting in Australia with Professor Hughes is just a very well-organized setting. They've done very large trials including also for Scamlix for example.

Speaker #3: And, of course, we're very happy that we now also have more direct visibility toward U.S. investors because of the analyst coverage that has started.

Speaker #2: So they know exactly what they're doing. So we're more than happy to let them run the trial but of course it doesn't come without costs.

Speaker #2: So we'll have to also pay the CRO involved which is a summary the institute that I mentioned with also specifically for example for this trial we will also have to make new GMP material.

Speaker #2: No, that's a great answer. I'm satisfied. Just one last quick question. Who funds the vital TFR2 study?

Speaker #2: So it's not going to be free but of course we're very happy with the way it's been set up and it will again be very cost efficient.

Speaker #3: That will be an investigator-sponsored trial, but it will, to a large extent, also be sponsored by us. I think you understand the principle—the vital CML trial is now ongoing as a corporate-sponsored trial.

Speaker #3: Very good. Thanks for answering my questions.

Speaker #2: Thanks.

Speaker #1: The next question comes from Aaron Atkar at Edison Investment Research. Please go ahead.

Speaker #3: So, we are formally the sponsor. The setting in Australia with Professor Hughes is just a very well-organized setting. They've done very large trials, including also for Scemblix, for example.

Speaker #3: So they know exactly what they're doing, so we're more than happy to let them run the trial. But of course, it doesn't come without cost.

Speaker #4: So I'm sorry. So I have a quick question on the expected biological informations from the Candace Combination trials. So could you clarify what kind of efficacy related or biological information investors should expect from this first data set?

Speaker #3: So, we'll have to also pay the CRO involved, which is Samri, the institute that I mentioned. But also, specifically—for example, for this trial—we will also have to make new GMP material.

Speaker #3: So, it's not going to be free, but of course, we're very happy with the way it's been set up, and it will, again, be very cost-efficient.

Speaker #2: Yeah, very good. Thanks for answering my questions.

Speaker #2: Yeah, I'm just going to check. This was not Aaron. This is Bye Bye maybe from Lucid.

Speaker #3: Thanks.

Speaker #1: The next question comes from Aaron Atkar at Edison Investment Research. Please go ahead.

Speaker #4: Yes, yes, yes. I'm sorry.

Speaker #2: No worries. No, it was not your mistake. You were just identified as somebody else. But thanks for joining the call. No, well, I think in an early stage of a trial the best thing you can do is look for initial signs of efficacy and that's both for the AML trial and the CML trials.

Speaker #2: What we'll always try to do is to have an initial indication of how the immune system is activated. Sometimes you start to see things quite early and other times you have to wait a little bit longer in the advanced two trial.

Speaker #4: So, I'm sorry. I have a quick question on the expected biological information from the Candace Combination trials. Could you clarify what kind of efficacy-related or biological information investors should expect from this first data set?

Speaker #2: We've always continued to work on these translational data and they have actually just been shaping up more and more. Things we are looking into for example is T-cell repertoire.

Speaker #2: We're doing Eli spot assays. We've looked into how the humoral compartment compares to T-cell compartment. So I can't give you a real black and white answer right now.

Speaker #3: Yeah, I'm just going to check. This was not Aaron. This is Baibai, maybe from Lucid?

Speaker #2: We have started to do these analysis both in our own labs in Leiden in the Netherlands but also in the labs of the Wihai Institute that's associated with the principal investigator with Andrew Wei.

Speaker #4: Yes, yes, yes. I'm sorry.

Speaker #3: No worries. No, it was not your mistake. You were just identified as somebody else. But thanks for joining the call. No, well, I think in an early stage of a trial, the best thing you can do is look for initial signs of efficacy.

Speaker #2: So the first and most important part was to establish safety. That was also the original objective of course of the stage one of the cadence trial.

Speaker #3: And that's both for the AML trial and the CML trials. What we'll always try to do is to have an initial indication of how the immune system is activated.

Speaker #2: But these other data will come in in a more granular level. Yeah, but it will be focusing on immunological parameters that we can get to the surface and also for example whether we start to see MRD events that indicated the immune system is actually taking care of the residual disease.

Speaker #3: Sometimes you start to see things quite early, and other times you have to wait a little bit longer in the advanced two trial. We've always continued to work on these translational data, and they have actually just been shaping up more and more.

Speaker #3: Things we are looking into, for example, are T-cell repertoire. We're doing ELISpot assays. We've looked into how the humoral compartment compares to the T-cell compartment.

Speaker #2: In the CML setting that will be very similar. So in the vital CML trial of course safety tolerability is the first and most important readout because it will also allow us to continue the trial and to start TFR2 trial.

Speaker #3: So I can't give you a real black-and-white answer right now. We have started to do these analyses both in our own labs in Leiden in the Netherlands, but also in the labs of the Wei Hai Institute that's associated with the principal investigator, Andrew Wei.

Speaker #2: We have already started also to look into the specific gene that drives CML which is sensitive to TKI. It's called BCR able. And we've started to look into immunological parameters.

Speaker #2: So also there we hope to quite quickly already after the initial safety readouts start to pick up what's called early molecular response data where you start to look for levels of disease being potentially affected by the immune system.

Speaker #3: So the first and most important part was to establish safety. That was also the original objective, of course, of stage one of the Cadence trial.

Speaker #3: But these other data will come in at a more granular level. Yeah, but it will be focusing on immunological parameters that we can get to the surface, and also, for example, whether we start to see MRD events that indicate that the immune system is actually taking care of the residual disease.

Speaker #2: But it's hard for me to predict right now in a black and white way what we exactly will pick up except for the fact that we will of course pick this up in the rest of the year.

Speaker #2: So in a relatively short period of time.

Speaker #4: I really appreciate that. If you don't mind me to ask a follow-up questions. So regarding the magnitude or patterns or BCR ABL1 reduction. So like what kind of level you would consider as like clinical encouraging early signal?

Speaker #3: In the CML setting, that will be very similar. So, in the VITAL CML trial, of course, safety and tolerability is the first and most important readout because it will also allow us to continue the trial and to start the TFR2 trial.

Speaker #3: But we have already started also to look into the specific gene that drives CML, which is sensitive to TKI. It's called BCR-ABL. And we've started to look into immunological parameters.

Speaker #2: Yeah, very good question. And let's put it this way. Patients that have been long time suboptimal responders to TKIs if you can convert any of those patients to a patient with sustainable DMR deep molecular response that's a terrific outcome.

Speaker #3: So also there, we hope to quite quickly, already after the initial safety readouts, start to pick up what's called early molecular response data, where you start to look for levels of disease being potentially affected by the immune system.

Speaker #2: And of course we hope it will be rather than less patients but we're looking for those initial signals that is possible that we can create a situation whereby the immune system becomes supportive of the TKIs and where the combined therapy will lead more patients into a DMR that eventually will also maybe make them eligible for TFR.

Speaker #3: But it's hard for me to predict right now, in a black-and-white way, what we will exactly pick up, except for the fact that we will, of course, pick this up during the rest of the year.

Speaker #3: So, in a relatively short period of time.

Speaker #4: I really appreciate that. If you don't mind, I'd like to ask a follow-up question. Regarding the magnitude or patterns of BCR-ABL1 reduction, what kind of level would you consider to be a clinically encouraging early signal?

Speaker #2: So the initial signals can be quite subtle but what we're looking for initially is the signals that we pick up after three months start of treatment.

Speaker #2: That's formally qualified as an early molecular response. And then at the end you also want to see the 12-month data to see if those responses continue.

Speaker #3: Yeah, very good question. And let's put it this way: Patients that have been long-time suboptimal responders to TKIs—if you can convert any of those patients to a patient with a sustainable DMR, deep molecular response—that's a terrific outcome.

Speaker #2: So that is the initial thing we will focus on. And any patient that we can convert from a suboptimal response to TKIs into a deep molecular response we will see as a success.

Speaker #3: And of course, we hope it will be more rather than fewer patients, but we're looking for those initial signals that it's possible that we can create a situation whereby the immune system becomes supportive of the TKIs, and where the combined therapy will lead more patients into a DMR that eventually will also maybe make them eligible for TFR.

Speaker #2: And of course if we combine that with the immunological parameters we start to pick up that actually something is happening in the immune system like we've seen that in AML but of course we need to confirm that in CML.

Speaker #2: I think that will already provide some at least very interesting initial correlative data showing that this principle holds up.

Speaker #3: So the initial signals can be quite subtle. But what we're looking for initially is the signals that we pick up after three months, at the start of treatment.

Speaker #4: I really appreciate that. Thank you so much.

Speaker #2: Thanks.

Speaker #1: And we'll try again with Aaron Atkar at Edison Investment Research. Please go ahead.

Speaker #3: That's formally qualified as an early molecular response. And then, at the end, you also want to see the 12-month data to see if those responses continue.

Speaker #3: So, that is the initial thing we will focus on. Any patient that we can convert from a suboptimal response to TKIs into a deep molecular response, we will see as a success.

Speaker #5: Hi there. Can you hear me?

Speaker #2: Yeah, perfect Aaron.

Speaker #5: Fantastic. Definitely getting used to the new system. Thanks very much for taking my question. I think most of them have been covered already actually but I do have two left.

Speaker #3: And of course, if we combine that with the immunological parameters, we start to pick up that actually something is happening in the immune system, like we've seen in AML.

Speaker #5: The first of which is it would be great if we could get a bit more detail on the planned US pediatric AML expansion. So notably what are the sort of the key hurdles between now and getting this program started in the first half of 2027?

Speaker #3: But, of course, we need to confirm that in CML. I think that will already provide some, at least, very interesting initial correlative data showing that this principle holds up.

Speaker #2: Yes, of course. Aaron, everything is subject to financing, right? So all these trials that we have been preparing for and that's also for the continuation of the trials that we have now put in place is of course expecting that we are able to continue to fund the company and to also add these additional trials to our pipeline.

Speaker #4: Really appreciate that. Thank you so much.

Speaker #3: Thanks.

Speaker #1: And we'll try again with Aaron Atkar at Edison Investment Research. Please go ahead.

Speaker #2: We have prepared the groundwork. That's a long story short. And the reason to move into this pediatric indications is twofold. First of all, there is a very high unmet medical need that we wish to address and also we are very happy that we can work with some of the best centers in the world to address specifically children with AML.

Speaker #5: Hi there, can you hear me?

Speaker #3: Yeah, perfect, Aaron.

Speaker #5: Fantastic. Definitely getting used to the new system. Thanks very much for taking my question. I think most of them have been covered already, actually.

Speaker #5: But I do have two left, the first of which is: it would be great if we could get a bit more detail on the planned US pediatric AML expansion.

Speaker #2: The other reason is that the setting in the pediatric indications allows for a quicker and also more efficient path to market which is necessary of course because we're talking also about much smaller patient numbers.

Speaker #5: So, notably, what are the key hurdles between now and getting this program started in the first half of 2027?

Speaker #3: Yes, of course. Aaron, everything is subject to financing, right? So all these trials that we have been preparing for, and that's also for the continuation of the trials that we have now put in place, is of course expecting that we are able to continue to fund the company and to also add these additional trials to our pipeline.

Speaker #2: But for us as a company from a strategic perspective it means that we on the one hand try to make the adult AML setting as big as possible because that has also been the main feedback that we have received from the pharmaceutical industry that there's a lot of competing drugs based on targeted therapies and fragments of the AML population but if we can deliver this as a therapy that applies across AML and across all of the first line settings or at least the backbone settings then of course that has a lot bigger commercial value.

Speaker #3: We have prepared the groundwork—that's a long story short. The reason for moving into these pediatric indications is twofold. First of all, there is a very high unmet medical need that we wish to address. We are also very happy that we can work with some of the best centers in the world to address specifically children with AML.

Speaker #2: But the trials that you need to get the product to market are quite bulky. And can be lengthy. So they would ideally benefit from a pharma partnership.

Speaker #3: The other reason is that the setting in the pediatric indications allows for a quicker and also more efficient path to market, which is necessary, of course, because we're talking also about much smaller patient numbers.

Speaker #2: But to have a pediatric program that is a lot more concise both in time and in patient numbers will allow us to also take this product to market ourselves.

Speaker #2: And that is why it combines the unmet medical need with also a more strategic element for the company.

Speaker #3: But for us, as a company, from a strategic perspective, it means that we, on the one hand, try to make the adult AML setting as big as possible because that has also been the main feedback that we have received from the pharmaceutical industry—that there's a lot of competing drugs based on targeted therapies and fragments of the AML population.

Speaker #5: Okay. That's very helpful. Thank you. And just one more question. Reflecting again on the sort of Moderna Merck positive news just there. Could you elaborate a little bit more on kind of what you think this means for the broader cancer vaccine field which I think is fair to say has sort of come up and down in terms of attention and also do you believe this paints a more positive light to Mendez's approach with the off-the-shelf strategy as opposed to personalized?

Speaker #3: But if we can deliver this as a therapy that applies across AML and across all of the first-line settings, or at least the backbone settings, then of course that has a lot bigger commercial value.

Speaker #3: But the trials that you need to get the product to market are quite bulky, and can be lengthy. So they would ideally benefit from a pharma partnership.

Speaker #2: Yeah, that's an excellent question. So let's not make too many associations but let's make the ones that are relevant. The most relevant is that we have discovered early on and I think also more and more the field as a whole including the specific setting that Moderna and Merck have been addressing that the immune system is most effective to prevent recurrence.

Speaker #3: But to have a pediatric program that is a lot more concise, both in time and in patient numbers, will allow us to also take this product to market ourselves.

Speaker #3: And that is why it combines the unmet medical need with also a more strategic element for the company.

Speaker #5: Okay, that's very helpful, thank you. And just one more question: reflecting again on the sort of Moderna-Merck positive news just there, could you elaborate a little bit more on what you think this means for the broader cancer vaccine field? I think it's fair to say that attention has sort of come up and down for this area. Also, do you believe this paints a more positive light on Mendus's approach with the off-the-shelf strategy, as opposed to a personalized one?

Speaker #2: And not so much to suppress higher levels of disease or to in the solid tumor space address more bulky tumor masses. The best setting to train the immune system against residual cancer cells is when you try to prevent recurrence which is factually the largest cause of death in cancer worldwide.

Speaker #2: So it's very relevant and I think this is really been a tremendous breakthrough that we have now seen in the late stage trial that kind of effect.

Speaker #3: Yeah, it's an excellent question. So let's not make too many associations, but let's make the ones that are relevant. The most relevant is that we have discovered early on, and I think also more and more the field as a whole, including the specific setting that Moderna and Merck have been addressing.

Speaker #2: So hands down for combination of Merck and Moderna for accomplishing that. What I think we should also be mindful of is that this doesn't solve everything.

Speaker #2: It starts with what makes an effective vaccine. Right? Formally we are by the way not a vaccine company. Our product is formally categorized as a cellular immunotherapy but it is an immunization strategy.

Speaker #3: That the immune system is most effective to prevent recurrence, and not so much to suppress higher levels of disease, or to, in the solid tumor space, address more bulky tumor masses.

Speaker #2: So with a bit of association you could call it a cancer vaccine. There are specific details that can only provide context which is that the solid tumors that have the highest mutation rate have also been shown to be most effective to the immune system.

Speaker #3: The best setting to train the immune system against residual cancer cells is when you try to prevent recurrence, which is, factually, the largest cause of death in cancer worldwide.

Speaker #3: So it's very relevant, and I think this has really been a tremendous breakthrough that we have now seen in the late-stage trial, that kind of effect.

Speaker #2: For example, the checkpoint inhibitor. So it's logical that firms like Moderna but also others like BioNTech etc have started developing algorithms and technology in this case mRNA technology to design vaccines that can very specifically zoom in on personalized neo antigens that can be compiled of a potential immunization strategy.

Speaker #3: So, hands down, a combination of Merck and Moderna accomplished that. What I think we should also be mindful of is that this doesn't solve everything.

Speaker #3: It starts with what makes an effective vaccine, right? Formally, we are, by the way, not a vaccine company. Our product is formally categorized as a cellular immunotherapy, but it is an immunization strategy.

Speaker #2: The myeloid blood cancers where we are active are very different. First of all, they seem to be unaffected by checkpoint inhibitors. And secondly, also to think through how we can design a product that is effective in training the immune system to take care of the residual cells.

Speaker #3: So, with a bit of association, you could call it a cancer vaccine. There are specific details that can only provide context, which is that the solid tumors that have the highest mutation rates have also been shown to be most effective to the immune system.

Speaker #2: We've taken a very different principle. And the principle again by association not direct scientific evidence but it's a logical thing to keep in mind is that we have learned from the transplants that the immune system can be curative and that there has to be an allogeneic mismatch between the immune system and the cancer cells.

Speaker #3: For example, the checkpoint inhibitors. So it's logical that firms like Moderna, but also others like BioNTech, etc., have started developing algorithms and technology—in this case, mRNA technology—to design vaccines that can very specifically zoom in on personalized neoantigens that can be compiled as part of a potential immunization strategy.

Speaker #2: It doesn't work if you get your own stem cells back. Right? And the basic principle of allogeneic stem cell transplant is that you basically replace the whole immune system by somebody else's immune system whereas what we have tried to accomplish is to show that if you give an allogeneic product a whole leukemic cell with all the antigens that it carries in a way to the patient's immune system that it triggers a broad immune response that that also works but will be a lot safer.

Speaker #3: The myeloid blood cancers where we are active are very different. First of all, they seem to be unaffected by checkpoint inhibitors. And secondly, we also need to think through how we can design a product that is effective in training the immune system to take care of the residual cells.

Speaker #3: We've taken a very different principle. And the principle, again, by association—not direct scientific evidence, but it's a logical thing to keep in mind—is that we have learned from the transplants that the immune system can be curative.

Speaker #2: So there's of course parallels and I think specifically the parallel is that the recurrence of tumors which is such an imminent threat to the health of patients can potentially be treated by these kind of therapies but I think we should also be mindful that such a breakthrough doesn't mean that everybody will be successful.

Speaker #3: And that there has to be an allogeneic mismatch between the immune system and the cancer cells. It doesn't work if you get your own stem cells back.

Speaker #2: I think it's still very important to find actual immunizations that work and that has been historically difficult. It's not that you if you look at the history of vaccines for example most vaccines were always designed on attenuated versions of the actual disease.

Speaker #3: Right? And the basic principle of allogeneic stem cell transplant is that you basically replace the whole immune system with somebody else's immune system. Whereas what we have tried to accomplish is to show that if you give an allogeneic product, a whole leukemic cell with all the antigens that it carries, in a way to the patient's immune system that triggers a broad immune response, that that also works, but will be a lot safer.

Speaker #2: And it was difficult to take them apart in individual antigens and what have you. So the fact that we now have a new standard in technology with Moderna and Merck showing that it can be done to filter out antigens and make personalized vaccines I think that is from a technology perspective a massive breakthrough.

Speaker #3: So there's, of course, parallels, and I think specifically the parallel is that the recurrence of tumors, which is such an imminent threat to the health of patients, can potentially be treated by these kinds of therapies.

Speaker #2: But I don't think we can compare that directly to what we are doing but I think we do have a very strong rationale and also of course very encouraging data to point out that our product may be very well designed specifically for myeloid blood cancers.

Speaker #3: But I think we should also be mindful that such a breakthrough doesn't mean that everybody will be successful. I think it's still very important to find actual immunizations that work.

Speaker #5: Fantastic. Great to hear your thoughts Eric. No more questions from me but congratulations again on a great author.

Speaker #3: And that has been historically difficult. It's not that you—if you look at the history of vaccines, for example, most vaccines were always designed on attenuated versions of the actual disease.

Speaker #2: Thanks Aaron.

Speaker #1: And with that we conclude the Q&A session. So I hand the word back to Dr. Erik Manting for closing comments.

Speaker #3: And it was difficult to take them apart into individual antigens and what have you. So, the fact that we now have a new standard in technology with Moderna and Merck showing that it can be done—to filter out antigens and make personalized vaccines—I think that is, from a technology perspective.

Speaker #2: Well thanks everybody for joining. Also on behalf of Lotta I'm sorry if there were some few technical glitches with the new system but we're very happy that we work with these people as well.

Speaker #3: A massive breakthrough. But I don't think we can compare that directly to what we are doing. However, I think we do have a very strong rationale and also, of course, very encouraging data to point out that our product may be very well designed specifically for myeloid blood cancers.

Speaker #2: So we'll continue to work on the technical details but I think it was a great call and thanks everybody for joining.

Speaker #1: Q26 report presentation. We will begin with a presentation from the company speakers. CEO Dr. Erik Manting and CFO Lotta Ferm. Following the presentation we will open up for questions.

Speaker #5: Fantastic. Great to hear your thoughts, Eric. No more questions from me, but congratulations again on a great poster.

Speaker #3: Thanks, Aaron.

Speaker #1: To ask a question press star five on your telephone to enter the queue. When it's your turn to speak press star six to unmute.

Speaker #1: And with that, we conclude the Q&A session. So I hand the word back to Dr. Erik Manting for closing comments.

Speaker #1: I will now hand over to CEO Dr. Erik Manting. Please go ahead.

Speaker #3: Well, thanks everybody for joining. Also, on behalf of Lofa, I'm sorry if there were a few technical glitches with the new system, but we're very happy that we work with these people as well.

Speaker #2: Thank you and welcome everybody on behalf of myself and Lotta.

Speaker #3: Hello everyone. Nice to meet you.

Speaker #2: Thanks for joining the Mendes Financial and Business Update over the second quarter of 2026. It was a very busy quarter with in which the clinical development gained a lot of momentum.

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