Earnings call transcript: Immunomedics Q4 2023 sees stable cash flow

Immunomedics (NASDAQ:IMMU) Inc. (Market cap: $34.46M) has reported its financial performance for the fourth quarter of 2023, highlighting a steady cash flow and strategic advancements in its clinical pipeline. According to InvestingPro, the company maintains a strong liquidity position with a current ratio of 6.65, suggesting robust short-term financial stability. The company continues to expand its focus on immunotherapy treatments for blood-borne tumors, with a particular emphasis on Acute Myeloid Leukemia (AML). Despite a challenging partnership climate, Immunomedics remains optimistic about its cash runway, which extends to early 2026.

Key Takeaways

• Immunomedics maintains a strong cash position with a minimal change of 8 million in Q4.
• The company is progressing with its CADENCE trial and preparing for a pivotal Phase III trial in AML.
• Strategic partnerships and manufacturing capabilities are a key focus for future growth.

Company Performance

Immunomedics is positioning itself as a leader in the development of immunotherapies for blood-borne tumors. The company’s lead product, VDN cell, is showing promise in both acute myeloid leukemia and ovarian cancer trials. Analyst consensus from InvestingPro suggests significant upside potential, with a price target of $2.50. Get access to detailed analysis and 12+ additional ProTips with an InvestingPro subscription. Immunomedics is also exploring additional indications, such as chronic myeloid leukemia, to broaden its therapeutic impact.

Financial Highlights

• Annual costs: SEK 136 million
• Annual cash flow: $20 million
• Q4 cash change: 8 million
• Cash runway: Secured through early 2026

Outlook & Guidance

Immunomedics is planning a Phase III trial targeting approximately 150 patients across 100-120 global clinical sites. The company is also focusing on establishing large-scale manufacturing capabilities with Northex Biologics, aiming for GMP readiness by the second half of next year. Additionally, Immunomedics is actively seeking potential partnerships to bolster its strategic initiatives.

Executive Commentary

CEO Erik Manting emphasized the company’s commitment to delivering meaningful patient benefits. "The only thing that really creates value is products that deliver meaningful benefit for patients," he stated, highlighting the company’s focus on long-term survival benefits and immune response tracking in AML.

Risks and Challenges

• Partnership challenges: The current climate for partnerships is difficult, which could impact future collaborations.
• CADENCE trial delays: Slower-than-expected progress in the CADENCE trial may affect timelines.
• High relapse rates in AML: The need for effective maintenance therapies remains a significant challenge.

Q&A

During the earnings call, analysts inquired about the company’s cash runway and its impact on the upcoming pivotal AML trial. Management confirmed that preparations for the trial are well-funded and not dependent on the progress of the CADENCE trial. InvestingPro’s Financial Health Score of 2.56 (rated as GOOD) supports management’s confidence, with particularly strong scores in relative value and growth metrics. Discover comprehensive analysis in the Pro Research Report, available exclusively to InvestingPro subscribers, covering what really matters for 1,400+ top stocks through expert analysis and intuitive visuals. Despite the challenging partnership environment, Immunomedics sees opportunities for collaboration in the future.

Full transcript - Immunomedics Inc (IMMU) Q4 2024:

Conference Moderator: Welcome to the Mendis q four twenty twenty four report presentation. For the first part of the conference call, the participants will be in listen only mode. During the questions and answer session, participants are able to ask questions by dialing 5 on their telephone keypad. Now I will hand the conference over to the speakers CEO, Eric Manting, and CFO, Lada Ferme. Please go ahead.

Erik Manting, CEO, Mendis: Thanks, and welcome everybody to the Q4 and year end webcast and business updates of Mendez. My name is Erik Manting, CEO, and together with our CFO, Lotte Ferme. As a summary of the main events of Q4, very importantly, we presented a survival update of our ADVANCE two trial in AMEL at the American Society of Hematology Conference at the end of last year, which demonstrated continued long term survival in the majority of patients. We also presented that ASH additional abstracts, which support the broader positioning of VDN cell in acute myeloid leukemia and also adjacent diseases such as chronic myeloid leukemia, which may support the further broadening of the addressable patient population with the elite product PDANCELL. The positive top line data from the LASM Phase one trial that we presented in December indicates that we, have a positive start of treating ovarian cancer patients with VDNCELL and that we can observe immune responses after three d Dansal administration against antigens that have previously been shown to be relevant for ovarian cancer, indicating that we are triggering tumor directed immune responses.

Safety was very good and we’re now awaiting a longer term survival data in Q4 of this year, to see how the, Viridensil product could be potentially developed in ovarian cancer. For the intertumoral primer that we are developing, ElixaDenzell, we showed that it combines well with the immune checkpoint inhibitor Availumab and we presented those data at the Society for Immunotherapy of Cancer Conference, in end of last year. But unfortunately, the clinical trial that we had anticipated to take place at the Institute Berg Gagne and a number of other larger French hospitals came to an end because the overall trial, third party funding was stopped and we were part of this trial to, to study elixidansa and soft tissue sarcomas, with the trial stopping that’s unfortunately no longer an opportunity. And we will look to potentially partner this program to take it forward in the clinic. Importantly, end of last year, we also received feedback from the FDA and EMA, so the regulatory agencies in The U.

S. And Europe on our registration trial preparations for VDNCELL. And what that indicates is that we’re on the right track. It means we are preparing for a trial that they consider appropriate, but also that the steps we are taking towards that late stage trial, including the setting up of large scale manufacturing is in accordance with our expectations. And finally, the large scale manufacturing alliance that we have with Northex Biologics is on track and that’s an important step to take towards pivotal stage readiness.

Now shifting to the numbers of Q4, I’ll hand over the word to Lotta.

Lotta Ferme, CFO, Mendis: Yes. Hello, everyone. And I will not talk so much about this. You can see what but what I would like to highlight is the difference between the costs in the company and the cash burn. As you can see in the report, the costs for the year has been around SEK 136,000,000, but the cash flow for the year is only $20,000,000 and that’s because of the warrants, which get in some extra cash in the beginning of the year.

But also in the Q4, the cash position changed only with 8,000,000 from end of q three, and that’s because we got some grants and also some interest on the bank accounts. And grants is very important for us because that’s how we have foundings for most of our preclinical work in the company. And the cash runway now will take us until the beginning of twenty twenty six.

Erik Manting, CEO, Mendis: Thanks. So as a pipeline overview, we are currently preparing for registration trial with our lead product, vidudansel in AML. We are still monitoring the ongoing Phase two data from the trials two trial and we are expanding the clinical development of IdiDENCEL in bloodborne tumors with the first trial ongoing, which is the CADENCE trial together with the Oscillation Leukemia Lymphoma group. And as I indicated, we are also exploring additional indications in the blood borne tumor space. And then we have the solid tumor programs, which is the earlier stage Allison trial in ovarian cancer, which is still to be confirmed in the sense of the next survival readout.

And we have the ELIXIDENCEL program, which we believe would make an interesting partnering opportunity for potential pharmaceutical or other biotechnological companies. So shifting to the main program, the main need for the treatment of AML currently is called maintenance therapy. And the reason is that AML or Q myeloid leukemia is very aggressive blood borne tumor that affects around forty five thousand people annually in Europe and The U. S. Only and around one hundred and forty five thousand people globally.

And it can only be treated with intensive chemotherapy and immediate chemotherapy to reduce the tumor burden. The big problem is the recurrence of the tumor, and the only way to prevent it currently is a bone marrow or hematopoietic stem cell transplant, but it’s unavailable for the majority of patients. And also a lot of patients already relapsed before they are even, in a position to undergo such a procedure. So the need for maintenance therapies that are able to prolong disease free and overall survival is huge. And that particularly relates to a phenomenon called measurable residual disease or MRD, which is present in the majority of patients after chemotherapy and is a critical factor in predicting relapse.

So there’s a increased association, of relapse with MRD positive patients. VDENCEL addresses this medical needs. So it’s a maintenance immunotherapy, designed to improve relapse free and overall survival in AML. The way it works is that after the initial treatment when the disease burden is low, we can administer VDN cells through interdermal injections, so injections into the skin. It stimulates the immune system with the aim to reduce the recurrence of the AML.

In the AVALCE2 trial, as a reminder, we have administered six vaccinations, four biweekly vaccinations followed by two boosters. The trial was conducted in 10 hospitals across Europe. The active study phase was completed, but we’re now in long term follow-up and the updated survival data of that long term follow-up was presented at ASH in December 2024. This was the data we presented and as you can see there is a continued long term survival in the majority of patients and that’s both relapse free and overall survival of patients that have been treated with CDDentil. All of these patients were MRD positive at study entry.

And as you will see the in the first year, a lot of patients relapsed and passed away. It was six patients in this case. But then the intriguing part is that the majority of patients stayed alive and then also stayed alive over a long period of time. What we could also show and presented at ASH is that the prolonged survival is associated with the immune responses that are stimulated by VDN cell treatment. And what you see in this graph is the difference between patients that had a sustained immune response.

So over time, multiple immune responses, following VDN cell administration and they are doing very well and significantly better than the patients without such a sustained vaccine induced response. But what we saw more than this, we also saw that B cells play a role, so the cells that produce antibodies. And we also realized that some patients had relatively high levels of suppressor cells called LAG3 positive T cells, even before the start of treatment, and that also was predictive of the outcome of the treatment. So the treatment itself leads to an increase in B cells and an increase in T cell responses as you can see in this graph, but also that to reduction of these inhibitory T cells And also at baseline, so before we started treating patients, we can already see that the patients that have a poor immune profile are also the patients that relapse relatively quickly. So the other way around, all the patients that had a good immune response were all long term survivors.

And this is a very clear, pattern that we can link to the mode of action of vidudansil and combined with the survival data, this is proof of concept that vidudansil acts as an active immunotherapy against residual disease and AML. And that puts us in a unique position to move this program forward. So we’ve decided to proceed towards a Phase three trial or registration trial and to make sure that the program is ready. So on the one hand that means we are designing a trial and we keep a close contact with the regulators to make sure that the trial we design would be a trial that would be sufficient for product registration. But also in parallel, we are setting up the large scale manufacturing of EDENSAIL.

And why is that relevant? It is because you want to have the final production process for your product ready and in place and also with the material coming out of that process before you start a potential registration trial. You don’t want to change the manufacturing protocol during the trial and that’s why this pivotal stage readiness is so much dependent on the manufacturing. With the feedback that we got from EMA and FDA, we got more comfortable with the fact that we are on the right track. And that doesn’t mean only for the trial, but also for the manufacturing and also for the whole dossier that we have around VDN cell, the regulatory dossier, but also the way we look at comparability, for example, of the products that we had from our old manufacturing process and now the product that we will get out of the new large scale manufacturing process.

So it means that we are on track, in preparing for pivotal stage readiness. Why is this important? First and foremost, we want to get this product on the market, right, and that will require, of course, additional means. It can mean a partnership, additional funding or a combination of both. But one way or the other, the program has to reach this stage because that makes it a product.

And I can’t emphasize that enough. This pivotal stage readiness is really a crucial milestone in the development of the product. And if we take that hurdle and we are well underway, I think we have a very attractive program to take forward either by ourselves or in the partnership. The broader AML maintenance landscape looks like this. So we are currently treating patients that come out of high dose or high intensity chemotherapy.

And currently, the only approved drug for AML maintenance in the patient population is a drug called oral azacitidine. And this is the current positioning. So the trial that we showed, the ADVANCE two trial is a single agent trial. It’s a monotherapy trial. There’s a next step we want to combine with standard of care.

And then you also have additional maintenance populations in the post transplant setting. So patients with transplants also have high levels of relapse. Actually, relapse is the most dominant factor for transplant failure. So that’s a patient population that could benefit from PDENTAL treatment. And then there’s also the chemo unfit patients, patients that are not able to undergo the high intensity chemotherapy who are today treated by a combination of azacitidine with venetoclax.

So these are two backbone drugs, in the treatment of AML. And when you combine them, we’re seeing higher complete remission rates in patients that were previously deemed untreatable or at least not treatable with chemotherapy. So, that’s a big shift in AML field. It also means that more patients achieve complete remissions with this combination and are also eligible for maintenance therapy. The big challenge is that, azacitidine as a backbone drug is relatively safe, but not very effective.

In the treatment of AML, the other way around, the venetoclax is rather toxic and very effective, but then also very difficult to handle as a maintenance drug. And this is where we believe we have a unique positioning of EDDancell in the broader AML landscape. But also there’s additional opportunities in other blood borne tumors. So as step one, we will combine with oral azacitidine. The graph on the right shows the current drug oral azacitidine and this was data from the registration trial, so the Phase III trial in MRD positive patients.

And what you will see is that you see a very fast relapse, so this is relapse free survival and that that relapse is slowed down by the acacitidine. That in itself is a reason to combine with acacitidine, but also there is a medical scientific rationale to combine VDENCEL with olelacitidine. And the reason is that the azacitidine has been shown in other trials to work very well in combination with immunotherapy approaches. And the main reason being that it increases the immunogenicity of cancer cells. So combined and also based on our own preclinical assessments, we believe that this combination will be beneficial for AML patients.

The first trial that we have launched in the expansion of the VDNCELL clinical development is a trial run by ALLG, the Oscillation Leukemia and Lymphoma Group. The setup of the trial is initially 40 patients to assess safety and tolerability and then we can expand to a larger trial up to 100 patients extra to look into the feasibility. This trial is for both MRD positive and MRD negative patients and it exposes also the product to a much wider group of hospitals because there’s a lot of hospitals associated with ALG and we are currently opening up multiple hospitals or ALG I should say is opening up multiple hospitals throughout Australia to support this trial. Then we have also looked into the additional maintenance opportunities and this is just to indicate that we are preparing for additional trials to potentially capture and broaden the addressable patient population in AML and potentially also adjacent diseases such as chronic myeloid leukemia, which is similar in terms of immunological profile, but it’s a different kind of disease. It’s slower disease than AML, much larger patient population.

And there’s a high need in chronic myeloid leukemia to provide patients with solutions to don’t have to take lifelong drugs. And immunotherapy could bring a solution. But of course, we need to test whether VDN cell could be a potentially, interesting drug to try and achieve those treatment free remissions. What we have presented at ASH were supportive data for the ASAP plus venetoclax combination, as I mentioned earlier, but also supportive data to study PDN cell in chronic myeloid leukemia. Then if we look at the other programs, the ovarian cancer program, as I mentioned, has shown promising initial data.

So not only have we seen tumor directed responses in the majority of patients, but also most of the patients, eight out of twelve with vaccine use responses had stable disease at week twenty two. So there seems to be an association between these responses and the disease progression, but we have to be very careful at this point in time to make stronger statements. The next follow-up will be in the fourth quarter of this year when we will have two year follow-up data from all the patients treated. Then for elixoDENCEL, it’s a program that we have put a lot of effort in. It’s been in the clinic extensively.

We’ve focused on making the manufacturing more robust and we were ready to go into a trial together with Institut Berg Gernier. But since the trial that we were part of was stopped, we have to reconsider our strategy and we have decided to look for potential partners. The main reason being that we have to focus on the lead program where we see the strongest data currently, but also we believe that in solid tumors there will be more and more combination strategies to treat difficult to treat tumors and we want to be part of that, but ideally in the form of a partnership. So to summarize, the updated survival data from the ADALMCE2 trial at ASH demonstrate and continue to demonstrate durable survival benefit of AML patients treated with three dencel. Preparations for registration trial are ongoing and they are now also endorsed by the feedback we received end of last year by Eman FDA.

We have established the large scale manufacturing alliance with Northex Biologics and are also on track for the major milestone that we want to achieve of GMP readiness, so the readiness to make clinical grade material in the second half of next year. And that will also be an important milestone for the pivotal stage readiness of PD Dencel as a program. We are expanding the clinical development of PD Dencel with the cadence trial or AMLM22 cadence trial in combination with oral azacitidine and we are also preparing for additional trial opportunities to broaden the addressable patient population in AML and adjacent diseases. The ELIXIDENCEL program is still an opportunity, but we will look to partner that program and the Allison Phase I trial in ovarian cancer is an earlier stage program, which is expected to deliver the next readout based on two year follow-up in twenty twenty five Q4, after which we can make clearer statements on what we’re going to do with that program. So with that, I would like to thank you on behalf of the management team and the board and open for Q and

Conference Moderator: The next question comes from Chien Shun Li from Pareto Securities. Please go ahead.

Chien Shun Li, Analyst, Pareto Securities: Hi, good morning and thanks for the update. So just two quick questions from me. First one is, so you extend the cash long way forecast until early twenty twenty six. Is it based on your current burn rate? And does that include the preparation for the pivotal AML trial?

And the second question is, how is could you provide some details on how does the cadence trial progressing? And can we still expect the first part of safety redoubt in first half this year? Thank you.

Erik Manting, CEO, Mendis: Thanks, Jen. I will let Lotta answer the question on the cash runway and I will take the question on the cadence trial.

Lotta Ferme, CFO, Mendis: Yes. The cash runway is based on the budget we have made for 2025 and that includes all the preparation work for the pivotal stage of Vidildansal.

Erik Manting, CEO, Mendis: So to cut the long story short, the financing we raised in 2023 into early twenty twenty four with the warrants that executed in April was basically meant to take this next milestone. And it means that we try to extend it as long as possible. We, of course, also focus on additional measures, cost saving measures, but also, for example, grant income to extend the cash runway. But the most important part is that we want to take the milestone of pivotal stage readiness and opening up more opportunities for the program with the cash that we raised in the previous round. Yes.

So and for the Cadence trial, Jan, to be honest, it’s taking longer than we hoped to open up these centers. It’s not of a lack of interest or lack of enthusiasm, particularly ALG is very enthusiastic. But when we look into the execution of the trial, it’s been slower than we had expected. We had expected to open up already a lot of centers before the year end. And actually, they started opening up centers end of last year.

And now, of course, they continue to open up more centers. But we are still waiting for the face first patient to be treated after that. And that’s also been our experience in the ADVANCE two trial, which you typically see is a kind of hockey stick pattern so that you see a faster ramping up of patient enrollment after the first trials have started enrolling patients. But we’re still in that in that mode is where we are opening up more centers and and and hopefully get started with the trial. Just to be clear, the trial is not necessary for the progress towards Phase three.

So the discussions we’ve been having with EMA and FDA were based on the ADVANCE two data, our plan to move forward in combination with oral azacitidine in the MRD positive patient population, which is the same patient population that we treated in the ADVANCE two trial. So that’s all on track. The additional benefit of the Cadence trial is first of all, it’s good that more people are exposed to the product and that we build up clinical network also in the end to be able to engage in registration trial. And also we have discussed with the regulators that we can use the data from the trial for our global registration dashes, although mainly deliver initially safety data, but we’re not dependent on the trial.

Chien Shun Li, Analyst, Pareto Securities: Okay. Thank you. Maybe a follow-up question on this. So as you mentioned, so the data from cadence trial will be feeding to the dose year for a registrational trial. But what if the cadence trial is somehow delayed?

Will you also start the registrational trial later? Or you will just start it no matter regardless of the safety data?

Erik Manting, CEO, Mendis: Thanks for that clarifying question, Chen, because we realized that can lead to confusion. The cadence trial is really a parallel exercise. So we are not dependent in the Phase III preparations on the cadence trial. The only thing we have made sure is that data from the trial can be used for the global registration dossier. So not so much the trial, but the dossier of Edencel.

And that has to do with the way you data also in the trials for example run by an external party, in this case, ALLG. You have to make sure that you collect data from a trial in a way that you can use them for your product. That is what we have secured. But it’s not so that the preparations that we take independently as a company are dependent on any progress or data from the cadence trial.

Chien Shun Li, Analyst, Pareto Securities: Okay. Yes, that’s clear. Yes, thanks for the clarification.

Erik Manting, CEO, Mendis: Thanks for your questions, Jan.

Conference Moderator: The next question comes from Arun Atkar from Edison Group. Please go ahead.

Arun Atkar, Analyst, Edison Group: Hi there. Good morning. Thanks very much for taking my questions. First of all, in terms of the cash runway extension into early twenty twenty six, you just mentioned now some cost saving measures to be as efficient as possible. Just wondering if you could provide a bit more color on the sorts of measures taken?

Lotta Ferme, CFO, Mendis: It’s more that we are looking into processes and routines and so on and especially in the admin area. So to make things more efficient and cheaper and looking over the vendors we are using and so on. So it’s not that it going out over the work in the labs or in the clinic and so on. It’s just that we try to work a bit smarter where it’s possible and when we have contracts which need to be renegotiated, we try to get something cheaper and so on.

Erik Manting, CEO, Mendis: Yeah. So we’re in an incremental automotive model, Aaron. That’s the long story short. And also we continue to focus on securing grant funding because we do want to keep a healthy balance between the clinical stage programs and the earlier stage research that we do to not only develop new things but mostly to support actually the progress of the clinical program. So VirudanCell in Botbol Tumors had a data we presented at ASH for example, as data that we largely collected ourselves in our own lab.

So we want to keep that research engine going, but at the same time by additional cost saving measures combined with grant income, we are able to extend and continue to extend our cash runway.

Arun Atkar, Analyst, Edison Group: Okay. Sounds good. Thank you very much. And my second question, just looking it’s quite exciting to see Videncial’s potential in additional settings. So the combination with azacitidine and venetoclax as well as for chronic minor leukemia.

You mentioned just earlier about some plans for some Phase II trials. So curious to know will these be pursued alongside the upcoming registrational trial? Or sort of can you provide any other guidance in terms of timing for these?

Erik Manting, CEO, Mendis: Yes. Well, first and foremost, the financing that we have raised is focused on reaching Phase III readiness. So in the internal communication, now also, of course, external communication about, I call it, the highway. So the main focus of the company is really about realizing this Phase three readiness, but it extends beyond the actual engagement in the Phase three trial. I think that will be heavy lifting for which we ideally seek a partner and otherwise we’ll have to raise substantial funding to engage in it.

You need to be ready to do that in any case, because the program itself matures by being Phase III ready, right? So that’s by far the biggest effort currently we pursue in the company. And the program has to be ready for Phase three, right? Because otherwise you’re also not a valuable partner for pharma, for example. So that’s the part we take care of and we take care of it with the funding that we secured in the last round.

The other trials just indicate that there is a lot of interest to work with the product and we believe it will be valuable to open up additional opportunities by additional trials. And those can be smaller company sponsored trials or it can be investigator sponsored trials. But in principle, we would like to see more addressable patients to be explored with this product, but also, of course, larger groups of clinical centers and clinical hospitals being able to work with the product. But that is subject to additional funding. And because currently, the focus is to get Phase III ready and to make sure that we extend our cash runway maximally to make sure that we reach that milestone and then look at all the options available to us.

The other trials, however, can become very valuable in the overall course of the development of EDENCELL. And then it will be a parallel exercise. So you focus on the Phase III, but then you also have the opportunity to expand your clinical development with additional smaller company sponsored or investigator sponsored trials.

Conference Moderator: The next question comes from Christian Binder from Redi.

Christian Binder, Analyst, Redi: Hi, and thanks so much for taking my question. I just have one quick follow-up. You mentioned partnering in your recently attended JPM, etcetera. Can you just elaborate a little bit on how do you feel the partnering climate is shaping up this year? And do you expect any significant changes that might benefit you?

Erik Manting, CEO, Mendis: Well, Christian, I think that’s the big question not only for us but also for the whole industry, right? If you look at what’s happening currently, it’s a very tough capital market that companies have to navigate through. I think also in terms of partnering, there has been some partnering successfully also even in Swedish markets for example, with companies like Kalidas and BioArctic for example. So the opportunities are there, but they are scarce And there is a lot of companies currently looking for ways forward. And what you start to see now is kind of new realism that, the markets will remain challenging.

Pharma partnering will remain a main way forward for a lot of companies, but it’s not going to happen for a lot of companies. So it’s a tough climate. That’s the start. I think what is the other mantra in this business is follow the data, Right? So what you start to see now is a system that was fueled by cheap funding, basically, because the low interest rates with a big boom in 2020, going through a significant cooling off.

And in the end, the only thing that really creates value is products that may that deliver meaningful benefit for patients. Right? And that’s a kind of new reality, and I think it’s a healthy reality. Right? And that is where we are in a good position.

I think the data that we have, the data that we just summarized today, long term follow-up in AML combined with the immuno monitoring data, I think that’s a pretty strong single agent activity that we’ve been able to pick up in a very crowded oncology space. And that stands out. The next step, of course, is can you make that product really ready for late stage development, including the large scale manufacturing, keeping everything on track with the regulators. And that is why we are so focused on it. So I think that should give us a good position.

Of course, I can’t go into individual interactions with pharma companies, but what is public information is that a lot of immunotherapy attempts in AML and in blood borne tumors as a whole, has failed. So something is missing. The checkpoint inhibitors, for example, that have revolutionized the treatment of solid tumors have not successfully been applied to blood borne tumors. We seem to have cracked the code to, allow the immune system to take care of residual cells, AML. So I think that is a very strong and unique finding.

And if we can translate this into a robust product with large scale manufacturing and robust dossier to take things forward to a potential registration trial, I think we’re in a good position to talk to anybody basically.

Christian Binder, Analyst, Redi: Perfect. That was all from my side. Thanks for the color.

Erik Manting, CEO, Mendis: Thanks, Christian.

Conference Moderator: The next question comes from Marek Shetinsky from Private Investor. Please go ahead.

Marek Shetinsky, Private Investor: Yes. Hello. Good morning and thank you very much for the nice presentation. I have a question regarding the number of patients that we are trying to take in the Phase III trial. And the second question, which is follow-up, because the safety from the previous study seems to be very good.

Is there any way that the bodies which are granting the permission like FDA and AMA, they will try to shorter the time for giving the products to the market and testing more patients? Thank you.

Erik Manting, CEO, Mendis: Thanks for joining Marek and thanks for your question. So, the long story short is we need to treat a significant amount of patients. Obviously the effect that we are seeing in the ADVANCE two trial is rather large. So it’s not an incremental effect, it’s almost a black and white effect, right, with patients that respond to the product also have a real long term survival. If we focus on the MRD positive patients, they have very high relapse rates.

So it should also be possible to have, let’s say, a more optimal readout if we focus on the high risk patients only. So with that, we assume we would have to treat roughly one hundred and fifty patients in a Phase three trial and that would mean we have to open up because it’s relatively rare disease and there is a lot of competition in the clinical development particularly of new induction treatments for AML. But you would have to open up roughly 100 to 120 sites globally. So it’s going to be quite an extensive trial to get the product registered and that is the conservative stance we can take now. So on the one hand, we can optimize the way we design the trial and limit as much as possible the patient numbers because we think we have an effect large enough to still be able to have an outcome that would be supportive of registration.

That is what we have checked, of course, also with EMA and FDA. But at this point, we don’t want to be more, let’s say, optimistic or aggressive in our statements with respect to potential accelerated approval. There may be ways to do that, but currently that’s not what we are assuming, Mark.

Marek Shetinsky, Private Investor: Thank

Chien Shun Li, Analyst, Pareto Securities: you.

Conference Moderator: Thanks. There are no more phone questions at this time, So I hand the conference back to the speakers for any written questions or closing comments.

Erik Manting, CEO, Mendis: Thanks so much, everybody for joining. Thanks for the questions. And we look forward to keeping everybody up to date with the progress we anticipate to make in the rest of the year. Have a good day.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.