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spk04: Ladies and gentlemen, thank you for standing by. Welcome to today's full year and fourth quarter earnings and business update conference call by AppMed NV. As a reminder, all participants are in listen-only mode. A question and answer session will follow the form of presentation. Please note this conference call is being recorded. I would now like to hand the call over to your host for today, Alex Budokidis, Director of Investor Relations at AppMed. Please go ahead.
spk06: Thank you, Livia, and thank you all for joining us today for our full year 2022 update call. Before we begin, I'd like to remind everyone that we issued the relevant press release earlier today, which can be found on the investor relations section of our website. On the call today, we have the members of our management team, including Adi Hirsch, our chief executive officer, Andreas Harstrick, our chief medical officer, Arne Sotelius, our chief scientific officer, Wolfgang Fischer, our Chief Operating Officer, Denise Miller, our Chief Business Officer, and Angus Smith, our Chief Financial Officer. The team will be available for the Q&A session after the prepared remarks. Before we start, I'd like to remind you that today's presentation contains projections and forward-looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this call. except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statement, even if new information becomes available in the future. These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in these statements due to various factors including but not limited to those identified under the section entitled Risk Factors in Our Filings with the SEC and those identified under the section entitled Forward-Looking Statements in the Press Release that we issued today and filed with the SEC. With that, I'll turn the call over to Ari. Ari?
spk13: Thank you, Alex. Good day, everyone, and thank you for joining us for our 2022 year-end results and operational update call. I'd like to begin by reviewing the key highlights of 2022, during which we made exciting progress across all our pipelines. Let's jump to slide four of the presentation. And importantly, in 2022, we generated highly compelling results with AFM13 in combination with natural killer cells. We did sign a partnership with Arteva now that gives us access to a commercially viable co-blood-derived natural killer cell And we advanced our other clinical programs, AFM24, and now most recently AFM28. From the data we reported, there are a number of key findings about our inertial engagers and their specific mode of action, which we believe are differentiating features versus other NK cell engager approaches, as well as engineered NK cells, including CAR NK. The unique mode of action of our innate cell engages generated from the ROC platform has always included the ability to engage different innate immune effector cells, such as NK cells and macrophages. And this effective engagement of the innate immune system has proven now to trigger an adaptive immune response, leading to a full immune response during T cells. We believe that this feature is unique to our inert cell engagement. As we show on slide five, this differentiating feature of our inert cell engagement molecule was demonstrated through our work in our AFM24 monotherapy study. Until the last year, we presented data on AFM24 monotherapy, showing this read-through to the adaptive immune system, the activation and migration of cytotoxic T cells into the tumor. We can further strengthen the full immune response through combinations with PD-1 or PD-L1 checkpoint inhibitors, which allow now these T-cells to attack the tumors in the tumor cells. The well-established safety profile of our inertial engagement molecule enables these combinations to deliver additional clinically meaningful benefits to cancer patients that indeed remain undeserved. The potential success of this combination approach was most recently observed in our AFM24 combination study with atezolizumab, where a gastric pain patient who had disfiguring skin lesions and failed to respond to any previous treatment, including a checkpoint inhibitor, had her skin lesions nearly fully eliminated with a substantial reduction in her primary gut GI tumor. Now let's jump to AFM13. With the completion of our Phase IIb redirect study, we demonstrated that AFM13 has single-agent efficacy and is safe and well-tolerable for patients. Redirect indeed showed good efficacy in a very difficult-to-treat patient population that currently only has very limited treatment options, in particular once relapsed refractory. As of the end of 2022, We have treated overall approximately 200 patients across all our AFM13 programs and saw a very consistent and manageable safety profile. Now, even though we saw efficacy for monotherapy, we made the decision to pursue the treatment based on the combination therapy of AFM13 with natural chelosomes. The much stronger efficacy seen with this type of treatment And the ability to address a much larger patient population led us to the decision to move forward with this combination. Our commercial analysis, as well as insights from our work on AFM13 with encasals, strongly now suggests that we can deliver more benefit to CD30-positive lymphoma patients with this approach, including Hodgkin lymphoma and T-cell lymphoma patients. Treating patients with a combination therapy is expected to deliver better and more durable efficacy. It is the right thing to do for patients, and it's also the most efficient use of company resources. Now, let me jump to slide six, which shows here our priorities for 2023. Our number one this year is the execution of the AFM13 AB101 clinical development plan. We call the program AFM13-203. We're looking forward to submitting the R&D and getting this important study up and running. We know from the data and our work with our partners at MD Anderson that the combination of AFM13 with NK cells can deliver meaningful therapy to patients with significant medical needs. Let me just give you an example. A patient that always comes to my mind is a young 54-year-old woman who was being sent to hospice after five lines of therapy that included combination chemo, brentuximab, bedotin, and an anti-PD-1 antibody. Now, this patient had a complete response with the AFM13 and KSO combination. This is the type of patient outcome is why we come to work every. We believe our TIVA cells as the key features that will allow for similar clinical results, as those resolved with the MD Anderson cell, and, very importantly, meet critical commercial requirements. Today, we can share with you that the data Akiva has seen so far from the AB101 rituximab combination study looks quite encouraging, particularly given that several patients are relapsed or refractory to prior Cartiva. expect to provide an update on this clinical trial later in the year. Moving on to April 24, we're generating data that will inform critical decisions on the future development path. As Andreas will discuss, we expect to have data from all three studies this year. This will allow us to analyze where we are seeing the most promising activity, thereby enabling our decision on where to focus further investment. Our third asset in clinical development is AFM28. Key activities for the monotherapy trial in Europe are underway with multiple CAs in place for approved sites and enrollment initiated at our lead site in Spain. Our goal in the phase one study is to confirm the safety profile and understand potential cytotoxic activity. Once we begin to understand the monotherapy profile, we intend to swiftly advance into a combination study with an NK zone, as we believe the science supports this approach as a compelling differentiated therapy. Now, with that, let me turn the call over to Andreas, who will provide additional insight on our clinical pipeline. Andreas?
spk01: Yeah, thank you, Adi, and a warm welcome to everybody on the phone. It's my pleasure now to give you an overview of our three clinical programs and the progress we are making. Let's turn to AFM 13, and on slide 9, you can see that we are making progress in our AFM 13 program. As we show on slide 10, at ASH in December 2022, We reported data from the Phase I-II study of AFM13 combined with cord blood derived in K cells that we are conducting in collaboration with investigators at MD Anderson in patients with relapsed and refractory CD30-positive lymphomas. In the 35 patients treated at the recommended Phase II dose, we saw a very high overall response rate of 94% and a complete response rate of 71%. Important, 31 out of these 35 patients that were treated at the recommended phase 2 dose were Hodgkin and Fulmer patients. In this subgroup, the overall response rate was 97%, and the complete response rate was 77%. in the four non-Hodgkin lymphoma patients that were treated. The anti-tumor activity was also encouraging with an overall response rate of 75% and a complete response rate of 25%. Another important finding was that four patients with Hodgkin lymphoma in this cohort had been previously treated with CD30 targeting CAR T-cell approaches. and had either not responded or immediately relapsed after CAR-T cells. In this cohort of four patients, all four patients also achieved a complete response. We are also encouraged by the durability of the responses observed so far. Specifically, 63% of the 24 patients treated as a recommended phase two dose and who had at least six months of follow-up at the data analysis, remained in complete response for six months. We, together with our colleagues from MD Anderson, expect to provide additional data from the study at a scientific conference towards the end of the year. I think it is also important to put things into perspective. This study was done in a very heavily pretreated patient population. The median line of prior therapies that patients received prior to enrollment into the study was seven. In addition to chemotherapy, all patients had received Britoximab-vidotin, and all Hodgkin lymphoma patients had also been pretreated with PD-1-containing regimens. A high proportion of patients, 78%, had also previously received a stem cell transplant. Probably even more important than this extensive pretreatment are the individual patient's characteristics. Important to note that none of the patients treated in the study had shown a response to their most recent previous line of therapy, indicating that the expected response rate that you could achieve in this specific patient population with available treatment is zero. The treatment was also very well tolerated in the larger patient population with minimal side effects beyond the expected myelosuppression that results from a lymphodepleting chemotherapy. Important to note, no instances of cytokine release syndrome were observed, no immune effector cell associated neurotoxicity, and no graft versus host disease were encountered. In summary, the data from the study demonstrate that the combination of AFM13 with national killer cells is highly effective and well tolerated for patients who have limited or no other treatment options. This makes the next step in the development for us even more important, which is trying to bring the combination therapy to more patients in need. As Adi has already mentioned, the next step is now to initiate our AFM13203 trial in collaboration with ARTIVA. In this study, we will combine AFM13 with ARTIVA's NK cell product AB101. As previously reported, we have been closely working with FDA in the pre-IND process on the design of the study. And here we can reiterate our guidance that we will submit an IND in the first half of this year and initiate the clinical study in the later course of this year. As you know, AB101 is an allogeneic, cryopreserved, cold blood-derived NK cell product, and it is already in clinical development. This off-the-shelf product offers a consistent and high CD16A expression, is produced at a GMP-grade manufacturing site with the right scale for larger clinical trials and future commercialization, at a viable cost of good structures. The new co-administered combination therapy of AFM30 with AB101 is designed to treat patients with relapsed refractory Hodgkin's lymphoma. The planned study will also have a separate exploratory cohort to evaluate the combination in relapsed refractory CD30-positive non-Hodgkin lymphomas. Let's switch to the AFM13 monotherapy study, our redirect trial. As we announced last week, we will present detailed data from this study in an oral presentation at AACR 2023. At our company event during ASH, we already presented top-line data showing that AFM13 is active as a single agent in pretreated patients with peripheral T-cell lymphomas, and is well tolerated. Now we look forward to share more information from this study with the scientific community. Let's now move to AFM24. As you will see on slide 11, we have made progress with our solid tumor ICE candidates. Important to note, we expect to report data from all three AFM24 studies at scientific conferences in the second or third quarter of 2023. For the monotherapy study, AFM24-101, the company expects to present data from approximately 15 patients from the non-small cell lung cancer and the colorectal cancer cohort. In the phase 1 to 8 combination study of AFM24, with the anti-PD-L1 checkpoint inhibitor artesalizumab, and from the AFM24 combination study with autologous NK cells. The company expects to report data from the dose escalation phases of both studies. In the AFM24 monotherapy trial, we are continuing to enroll patients in the expansion phase at the recommended phase two dose of 480 milligrams weekly. As you know, these expansion cohorts includes patients with renal cell carcinoma, non-small cell lung cancers who are EGFR mutant, and colorectal cancer, KRAS wild type. New qualitative science data that we published at CITSE last year demonstrate that AFN24 effectively activates the innate immune system and also triggers the adaptive immune system in the periphery and in the tumor. We believe this is a significant new finding as we are observing the activation of cytotoxic T cells in the periphery and in tumor biopsies. pointing to the activation of the adaptive immune system in addition to engagement of NK cells and macrophages. NK cells and cytotoxic T cells increased in biopsies of AFM24-treated patients who received doses of 160 milligrams and above, indicating that cytotoxic cell function of both NK cells and T cells are increasing. We believe this finding provides strong evidence for the cross-activation of the adaptive immune system as an additional mechanism of action of our innate cell engagers. We believe that these data strongly support the combination with checkpoint inhibitors as we are doing with AFM24102. On slide 12, We are showing the initial data from the study that's presented at CITSI last year. Here we show a gastric cancer patient that has already been pretreated with pembrolizumab and chemotherapy combination in first line, followed by three lines of various chemotherapies before being included in the study. This patient showed a partial response, including noticeable reductions of the skin metastasis which had not responded to any of the prior treatment lines. It's important to note that this patient had a short-lasting response with previous treatment of a combination of chemotherapy and PD-1, which was followed by progression while still receiving PD-1. And thus, it represents a patient in whom a response to PD-1 we challenge is very unlikely. The second patient in the study, a patient with pancreatic adenocarcinoma, exhibited clinically meaningful stable disease on the combination of AFM24 with atezolizumab after showing progression on three different chemotherapy regimens prior of being enrolled into the AFM24-102 study. The second combination of AFM24 is investigating the combination of AFM24 with SNK01 The ex vivo expanded and activated autologous NK cell therapy from NKGen Biotech. Both given weekly to patients with non-small cell lung cancer, squamous cell carcinoma of the head and neck, and colorectal cancer. In this study, we are currently confirming the recommended phase two dose of 480 milligrams on three additional patients. Now let's move to AFM28. And on slide 13, we show the progress of this ACE designed to bring a new immunotherapeutic approach to patients with CD123 positive myeloid malignancies, including AML and myelodysplastic syndrome. AFM28 engages cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity. even at low CD123 expression levels. Given the aggressive nature of the disease and need for viable treatment options, we are working hard to bring this treatment option to refractory and relapsed AML patients as quickly as possible. As a reminder, the most recent poster presented at ASH 2022 showed that AFM28 induces NK cell-mediated lysis of CD123 positive tumor cells with high efficiency and potency. ADCC activity in vivo was not affected, in vitro was not affected by high mutational status or low 123 expression. And in contrast to FC-enhanced monoclonal antibodies, Activity is also unaffected by CD64 expression. AFM28 demonstrates that ex vivo AML and MDS patients' bone marrow samples efficiently can be depleted of both 123 positive leukemic cells and importantly also of leukemic stem cells. And AFM24 has exhibited potent antitumor activity in urine AML models. In the meantime, we have received clinical trial application approvals in four European countries, including Belgium, France, Denmark, and Spain. As Adi mentioned, the study is open for patient enrollment now. With this, I will turn over the call to Angus to update you on our quarterly financial numbers. Angus, please.
spk08: Thank you, Andreas. Balance sheet and income statement highlights are shown on slides 15 and 16 of the presentation. APIMED's consolidated financial statements have been prepared in accordance with IFRS as issued by the International Accounting Standard Board, or IASB. The consolidated financial statements are prepared in euros, which is the company's functional and presentation currency. Therefore, all financials that I will present in the call today, unless otherwise noted, will be in euros. We ended 2022 with cash and cash equivalents of 190.3 million euros compared to 197.6 million euros on December 31st, 2021. Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents will support operations into 2025. Net cash used in operating activities for the year ended December 31st, 2022 with 104.9 million euros compared to 86.6 million euros in 2021. Total revenue for the year ended December 31st, 2022 was 41.4 million euros compared with 40.4 million euros for the year ended December 31st, 2021. As a reminder, revenue predominantly relates to the Genentech and Roivant collaborations. Research and development expenses for 2022 increased by 21% from 81.5 million euros in 2021 to 98.8 million euros in 2022. The increase was primarily driven by higher expenses associated with the development of AFM24 and AFM28, a result of an increase in manufacturing of clinical trial material and costs for the preparation of the filing of an IND application, an increase in costs associated with other early programs and infrastructure, and an increase in share-based payments. General and administrative expenses increased 32% from 24.2 million euros in 2021 to 32.1 million euros in 2022. The increase predominantly relates to higher personnel and share-based payment expenses and an increase in insurance premiums and higher consulting costs. Net finance income for the year decreased from 6.5 million euros for 2021 to 2.1 million euros in 2022. Net finance income is largely due to foreign exchange gains related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and the euro during the year. Net loss for the year ended December 31st, 2022 with 86 million euros or 60 cents per common share compared with a loss of 57.5 million euros or 48 cents per common share for the year ended December 31st, 2021. The weighted number of common shares outstanding for the year ended December 31st, 2022, was 142.4 million. Finally, we encourage shareholders to also review our 20F filing for the year, which will be filed with the SEC later today. I will now turn the call back to Adi for closing remarks. Adi?
spk13: Yeah, thanks, Angus. As you've heard, we make progress across all our pipeline projects, and I believe we're putting the right pieces in place for a series of milestones now during 2023 and even beyond. Our pipeline is further enhanced through the initiation of the phase one study of AFIM-28 in AML, more to come. We continue to make progress with our ongoing partnerships. In the case of Genentech, we have handed over several programs to them for further preclinical development. In our second collaboration, AfriOne Sciences, a roving company, submitted two per-clinic labs abstracts, which have been accepted for poster presentation at the ASCR annual meeting this year. Apriband expects to submit 90 for AVT 2101, formerly AECOM 32, in the first half of 2023. With this, I'd like to thank you for all your continued support for the patients and their families, and for our employees in the US and Europe We're passionately dedicated to our efforts to bring life-saving medications to cancer patients. We're now ready to take your questions. Thank you. Operator?
spk04: Thank you. Ladies and gentlemen, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, press star 11 again. Please stand by while we compile the Q&A roster. And our first question coming from the line of from SBB Securities. Your line is open.
spk03: Hi, guys. Thank you for the question. I have a couple part question on the ASM24 data. You say, first one on the timing, you say Q2 or Q3. Is that because, you know, you're submitting abstracts already, you have data in hand and it's a matter of which conference, or you're still gathering data and haven't decided which conference to submit to yet. And the second question, also on AFM24, I wonder if you could give us some context of the type of patients to expect in the lung cancer and CRC monotherapy cohorts. For instance, in lung cancer, all presumably will be post an EGFR TKI. Should we also expect them to have been exposed to amibansumab, for instance, and for CRC exposed to cetuximab? Thank you very much.
spk13: Yeah, thanks, Dana. I'll hand over to Andreas. Andreas, can you take the questions?
spk01: Yeah, sure. Hi, Dana. So let's start first with the timing, and you're absolutely right. We are targeting a couple of conferences in the second third quarter of 2023. So for some of those, we have submitted abstracts. For some of those, we Will we submit in abstracts with updated data? And now we are waiting feedback from these conferences. Important to note, at the time of the conference, we will always provide the most updated data that probably will include more patients or longer follow-up than even reported in the abstracts. So this explains a little bit why we have this guidance Q2, Q3. Now, in terms of patient populations, specifically for the 101 study, let's start with colorectal. For this specific colorectal cohort, we expect that patients will have in the majority two to three lines of chemotherapy, at least two lines of chemotherapy. They will all have been exposed to the standard drugs like afluoroperimidine oxaliplatin, irinotecum in various permutations. They can have additional drugs and they will also be exposed to Erbitex or another EGFR targeting medication. In terms of our non-small cell lung cancer cohort, again, this is restricted to patients with activating EGFR mutations. The requirement here is that all patients have exhausted targeting therapy. So this could either be an ozimertinib as a starting therapy or a sequence of a first, second generation TKI followed by ozimertinib. Patients can have also additional chemotherapy on top of CTKI treatment, but this is not an absolute requirement. So we probably have a mixed population of patients who have exhausted all TKI options and also some patients who have TKI and chemotherapy and then go on the trial.
spk03: And do you know if there's amobantumab exposure in the cohort?
spk01: We have not specifically looked for that yet. It would be permissible to have it, but it was not a requirement prior to going on to this trial.
spk03: Great. Thank you.
spk04: Thank you. One moment please for our next question. And our next question coming from the line of from .
spk05: Hey, guys. Thank you so much for taking my question. I've got a couple of questions on AFM13. So for the combo study, I think you said on a recent investor call that you expect to find IND in first half and start treating patients in second half. Can you help frame timelines for, you know, from IND acceptance to when you will start treating patients? What sort of work you can do in terms of getting patients sites up and running before the IND acceptance. And then for AFM24, you have both with AFM13 you have a partnership with cord blood derived cells and then with AFM24 you have autologous. Based on the IND process that you're going through with both of them, Do you see one being easier than the other? Maybe it's too early, but just wondering if you have any thought process into that going out into the future. Thank you.
spk13: Yeah, let's start with 24 first. Andreas, can you go ahead with the 24 answer? That will jump back to the regulatory question.
spk01: Yeah, okay, for 24, I try to remember all the different aspects. So one question was relating to the different NK cell sources, right? So whether autologous or allogeneic NK cells are more or less difficult. We cannot finally say because for AFN24 and the NKGEN autologous cells, obviously we have completed our IND process and already have an open study. I can say that FDA was extremely collaborative on this IND. And, yeah, so this was a rather smooth process. Again, also for the allogeneic process with AFM30, we have very collaborative interactions with FDA. We have not completed the IND process yet, so it's hard to compare these two processes. But, again, the attitude and the discussions with FDA have been very constructive in both cases. Okay, fantastic. And now your second part of the question was?
spk05: Yes, I'm 13. So once you have the IND acceptance, I was just wondering how long it would take for you to start treating your first patient and what work you can do ahead of time to get the centers up in January?
spk01: Yes, I think we, yeah, we can give, of course, only detailed guidance once we have the protocol finalized and the final blessing, if you will, by FDA. Now, we are already looking, doing feasibility studies at sites. We have identified our primary lead investigator. We are now working with key opinion leaders in the field to smoothen the setup process of sites as good as we can. We have identified a CRO that will support us in our study conduct. But again, final timelines can only be given after we have a final protocol.
spk05: Great. Thank you so much for taking my question.
spk04: Thank you. And our next question coming from the line of Mari Raycroft with Jefferies. Your line is now open.
spk07: Hi. Thanks for taking my questions. I was going to ask one on the AFM13 combo as well. Wondering when you plan to update the street on additional trial design details, and what are your latest thoughts on what the FDA wants in terms of bridging or dose lead-in for the AB101 cell combo?
spk13: Yes, Morgan, thank you. So as we've said in the past, we've had verifying interactions with FDA, and we have been basically bringing this together into the study design. So, obviously, we have a good understanding, a very good understanding how that should look like. I think in the past we have said that we intend to give the NK cell in combination with AFM13 as weekly installment over roughly three weeks, and then we follow with three weekly doses of AFM13, or this is preceded by lymphodepletion, And then roughly after eight weeks of basically from start of treatment, you're going to do your restaging. And then you include a short break before you go to the second cycle and third cycle. So in general, we have already explained what the study design is going to look like. So based on the feedback with FDA, we have made the respective adaptations consistent. And as soon as we have the final ING, we can update you on the further details. I hope this helps.
spk07: Yes, yeah, that's helpful. And also wanted to ask about the monotherapy AFM24 update. So for the approximate 15 patients in CRC, non-small cell lung cancer, what's the internal bar for success there in terms of a go or no-go decision? And will that decision be made in the second quarter or third quarter update? I'll hand over to Andrea.
spk01: Yeah, so as you know, clinical data always have multiple aspects. So we have some ideas about response rates that we want to see. We also have some ideas about the duration of responses we want to see. We have not communicated those, and it will always be a composite of these two parameters in addition to patient characteristics, how refractory are these patients, what's the pre-treatment pattern. Our intention clearly is to make go-no-go decisions based on these data, and as these data are maturing, we will have, I think, better discussions or more detailed guidance once we have disclosed these data.
spk07: Okay, that makes sense. Thanks for taking my questions.
spk04: Thank you. And our next question coming from the line of Lee Wacek from Cancer. Your line is open.
spk02: Hey, thank you for your questions. Maybe just one on AFM 13. Maybe clarify if you had additional interactions with FDA regarding your R&D. filing since your pre-IND meeting, and what are the remaining steps that you have to go through to have it filed?
spk13: Wolfgang, you want to take this question?
spk12: Yes, I can take my question. Thank you. So, first of all, we had the pre-IND, right, which we got feedback early in January, and we got constructive feedback. We had one or two clarifying questions. for the FDA, and we got responses. And with this constructive feedback, right, we are currently working on the documents to submit the IND, as we said, in the first half of this year. And as Andreas already mentioned before, the feedback has been very positive and constructive. So we're looking into, and we didn't see any roadblock, and now we are preparing to submit.
spk02: Okay. And then maybe a question on AFM 28. Since now you have R&D clearing for European countries and have been enrolling, you know, patients, maybe just update us on maybe how the enrollment is ongoing. And it seems like you can make a pretty quick rate on maybe response rate and see our EML patients. So any chance that we might see some data this year?
spk13: Andreas?
spk01: Yes, we said we have CTA clearance. The study is open for enrollment, so we are just starting enrollment. Therefore, of course, we cannot say anything about what we have seen so far. And then we have not given clear or detailed guidance about the data releases. This will come once we see the initial enrollment of these patients.
spk04: Okay, thank you. Thank you. One moment, please, for our next question. And our next question coming from the line of from .
spk10: Good morning, and thanks for taking the question. Again, on AFM 13203 study, just like to know how many sites you are planning at this point And what would be the overall goal in terms of just bridging the earlier study, or you anticipate more in terms of potential status, for example, phases of the study, whether that will lead into more advanced trials? And I have a follow-up. Thanks.
spk13: Welcome. You want to take that?
spk12: Yeah, I can take that. Thank you. So, number of sites, we are working with the several sites. I do not have the exact number on top of my head, but it's about 12 to 15, if I recall that correctly. And the objective of our trial is to confirm what we have seen in the MD Anderson trial. This is, we are convinced when we see that the AB101 cell is a good cell, which works very well with AFM13. We have seen that in all our preclinical studies demonstrating that. So, it's to confirm what we have seen with MDM.
spk10: Okay, great. Maybe the follow-up here is that in terms of AFM1DA, and your prepared test may indicate that subsequently you will use a added to a NK combo study. I'm just curious, in this case, would that be AB101, or you have other options, or it has not been determined in effects?
spk13: Yeah, exactly. So we have not announced it, let's put it this way. And in the moment we're following how 8 and 20 is doing, and 28 is now performing in the clinic, And then in due course, we're going to make the next decision on how that's all going and which cell we are using.
spk10: Okay, great. Thanks a lot. I appreciate it.
spk04: Thank you. And our next question coming from the line up. Brad Canino from Stifel. Your line is open.
spk11: Hey, this is Bajon Moore from Brad Canino. Thanks for taking our question. For the ASM24 combination studies, how many patients should we expect to see in the upcoming data? And will there be enough efficacy for us to determine the contribution of parts? Andreas?
spk01: Yes, we said the focus for the two combination studies will mainly be on safety and the definition of the individual recommended doses that we are using in these combinations. For 102, the combination study was a tesolizumab. We have recently opened expansion cohorts. So we will see some patients, but again, the efficacy data to expect that more towards the end of the year or early next year. So focus here on recommended phase two dose, same probably for 103.
spk11: Yeah, that's clear. Okay, thanks. And then one on AFM13. What should we learn to expect from the AACR presentation that could be helpful for the NK cell combo study?
spk01: Again, no jokes. You mean the AFM13 monotherapy study that we are discussing in detail? This will be mainly detailed description of the activity of monotherapy of AFM13 in PTCL, looking at the safety profile, looking at activity in individual subgroups, providing further data in terms of follow-up. I think there is not very much to learn for the specific combination study. As you know, the primary target population of the combination study is Hodgkin's lymphoma. where we intend to generate through the 203 study a data set that would be able to support an accelerated approval. Now, the data that we show at ASCO will be on PTCL, peripheral T cell lymphoma, so different tumor type. Here we also have an exploratory cohort in our 203 study, which will provide us further guidance on the next steps with NK cells and AFM13 also on PTCL.
spk13: Andres, you said ASTU, but you meant AACR. So the presentation on AACR therapy will be at AACR.
spk01: Yeah. Sorry. AACR, of course.
spk11: Thank you.
spk04: Thank you. One moment, please, for our next question. And our next question coming from the lineup. So I am Pakula Ramakant from AC WinRAR. Your line is open.
spk09: Thank you. I apologize. Another question on AFM13. This is on the 203 program. Just trying to understand the rationale behind CD13 positive, the exploratory cohort which you're looking at, the CD13 positive, relax refractory NHL.
spk01: Yeah. Yeah. Thank you. Yeah. Yeah, this study is open for CD30-positive lymphomas, as was the MD Anderson study. It basically has two parts. So the larger part and where we are focusing on our registration intent is for patients with Hodgkin lymphoma. I think here the MD Anderson data have provided clear proof of concepts, as Arndt and others have elucidated. We believe that The AB101 cell has the activity and the type of biology that should enable us to replicate these data with a very high response rate, with a good duration of responses. So this is the main part of the study. As we have also shown, we have seen good responses also in non-Hodgkin lymphoma in the MD Anderson study. However, this is only four patients so far. So the 203 study has a separate cohort that enrolls peripheral T-cell lymphoma patients, tries to, or is looking for the response rate also in peripheral T-cell lymphoma patients. And once we have seen this data, we will have a further decision how to proceed also in peripheral T-cell lymphoma patients. Based on the limited data that we have seen in these four patients at MD Anderson, we believe that also peripheral T cell lymphoma is an indication that will benefit from the combination of NK cells and AFM13.
spk09: Perfect. Thank you very much, Andreas.
spk04: Thank you. I'm showing no additional questions at this time. I'll turn back to the speakers if there's any closing remarks.
spk13: Yes. Thank you very much for listening in. This finishes our year-end update call of the year 2022. And as we've just mentioned, we have a lot of milestones coming up, in particular for AFIM 13 with initiation of the registration-directed study based on a filing and feedback from FDA, hopefully to come soon. And then we have AFIN24 with multiple data readouts starting in Q2, but basically going into Q3 and Q4 of this year. And last but not least, AFIN28 is open for recruitment. So again, that should lead to hopefully some initial data that will keep you updated as usual, at least on the earnings calls. And we will also move forward when we have some reasonable data to submit further abstracts. With that, I conclude the call, and thank you for listening in.
spk04: Ladies and gentlemen, that's our conference for today. Thank you for your participation. You may now disconnect.
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