Affimed N.V.

Q1 2022 Earnings Conference Call

6/1/2022

spk05: Good day, and thank you for standing by. Welcome to the Affirm AFIMED first quarter 2022 financial results corporate update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to Alex Sudeikides, Head of Investor Relations. Please go ahead, sir.
spk03: Thank you, Norma, and thank you all for joining us for our call today. Before we begin, I'd like to remind everyone that we posted the relevant press release and presentation on the Investor Relations section of our website earlier today. 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 Chatelius, our Chief Scientific Officer, Wolfgang Fischer, our Chief Operating Officer, and Angus Smith, our Chief Financial Officer. The team will be available for the Q&A after the prepared remarks. Before we start, I would 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 subjects to risk 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 and our filings with the SEC and those identified under the section entitled forward-looking statements and the press release that we issued today and filed with the SEC. With that, I'll turn the call over to Adi. Adi?
spk13: Thank you, Alex. Good day, everyone, and thanks a lot for joining us for this call today. I'd like to take a moment to review what we have achieved so far, especially against the challenging backdrops like the global pandemic, geopolitical tension, and volatility in the capital market. In the last few years, we have built a differentiated therapeutics pipeline of innate cell engagers, established a clinical proof of concept for our three-pronged development strategy, reinforced our senior leadership team and strengthened our balance sheet. More recently, we presented highly meaningful proof of concept data for our pioneering approach of treating heavily pre-treated patients with a combination of an inertial engager and allogeneic natural killer cells. We also recognize the need to build a solid financial base to allow now swift execution of our programs they're very pleased to have recently completed the 103.5 million public offering with these proceeds we have the resources required to move our key wholly owned programs just mention them here a from 13 a from 24 and a from 28 to important inflection points over the next 12 to 18 months In the first quarter of this year, we announced the completion of enrollment of our redirect study, which treats patients with relapsed refractory peripheral T-cell lymphoma with AFM13 monotherapy. We expect to report the top-line data from this study in the fourth quarter of this year. For the AFM13 study in combination with natural killer cells, Following the compelling data that were reported in December of last year, we presented updated data at AACR and we showed a strong increase in complete responses after two cycles of therapy at the recommended phase two dose and very encouraging signs of durability. We believe these data continue to validate the program and the overall approach. The data presentations in December 2021 at AACR have led to an increased interest by the pharmaceutical industry and treating physicians. And as a result, MD Anderson has been enrolling additional patients with Hodgkin lymphoma and other CD30-positive non-Hodgkin lymphoma. We indeed had planned to present new data from this study on additional patients, including important correlative signs data at ASCO which we now plan to present at a medical conference in the second half of this year. Moving on, for AFEM24, our ETFR targeting units and engager, we continue to enroll patients in all three clinical trials based on our three-pronged development strategy, and we're planning to present data in the second half of this year. And for AFEM28, our CD123 targeting inner cell engager, we're on track to submit an R&D in June for clinic evaluation of patients with relapsed and refractory AML. We expect to initiate the phase one clinical trial in the second half of this year. We're also continuing to make progress in our work with our partners at MD Anderson, NKGEN and other third parties to ensure access to an off-the-shelf cryopreserved natural killer cells for further development with our ICE inner cell engager therapy. We expect to provide additional updates on our NK cell development strategy in the second half of 2022. We are advancing also our work with existing collaborators. In the case of Genentech, we have made good progress in various preclinical programs and handed over several programs to them for further preclinical development. Through our partnership with Roivant, AFM32 is currently being investigated in ING enabling studies. We are eligible for additional proceeds from these key collaborations in the near term, including preclinical milestones as well as milestones based on early regulatory achievements. We are also very encouraged by the data presented by our peers in the innate immune field and the interest from the pharmaceutical industry in therapies based on innate immunity. There is a growing recognition that engaging the innate immune system can play an important role in fighting cancer and we are particularly proud to be among the first companies to have produced positive clinical data through this approach. As our data have shown, our three-pronged approach has the potential to provide benefit to patients that have very limited treatment options and indeed urgently need novel treatment. We aim to bring our drugs forward to registration-directed studies in the near future, and we believe this is creating a strong commercial opportunity
spk11: for each of our molecules with that i will turn over the call to andreas to give you more color on the progress on the program andreas yeah thank you adi and also a warm welcome from from my side um i will run you as adi said through all of our development programs and I'll start with AFM13 as shown on slide four. As you know, we are conducting two studies with AFM13, our registration-directed study for AFM13 monotherapy in patients with relapsed refractory peripheral T-cell lymphoma, also known as a redirect study, and our Phase I-II study that we are conducting in collaboration with MD Anderson. and where we are evaluating cord blood-derived allogeneic NK cells that are pre-complexed with AFM13, followed by AFM13 monotherapy in patients with relapsed and refractory CD30-positive lymphomas. Let's turn to the study AFM13104, the NK cell study first. At the recent AACR conference, Dr. Iago Nieto, the lead investigator at MD Anderson, reported the activity data of this approach after the second cycle of treatment for all patients at the recommended phase two dose. Interestingly and importantly, the rate of complete responses at the recommended phase two dose with the second cycle increased from 38%, as reported in December, to 62% at the final analysis. The overall response rates remains at 100%. It's important to note here that treatment is safe and very well tolerated. The main side effects were in fact associated with the lymphodepleting regimen, namely short duration neutropenia and short duration thrombocytopenia. I would highlight here the fact that these are mainly, I would say, laboratory side effects. Important to notice that they were not associated with any clinical consequences, and we did not observe neutropenic fever or no signs of relevant bleeding. Also important, we did not observe any cases of cytokine release syndrome, any cases of neurotoxicity or graft versus host disease. which are often associated with T-cell-based therapies. So after reviewing the side effects and learning that they had transitioned, they did not lead to treatment delays or discontinuations. This led us and our colleagues at MD Anderson to believe that the safety and tolerability profile of this treatment will allow treating patients with more than the current two cycles And in fact, at MD Anderson, we are already treating patients with a third cycle. Durability data at the recommended phase two dose were also very encouraging. Of the eight patients who achieved a complete response, seven remain in complete response after a median follow-up of 6.5 months, including two patients in complete response for more than 10 months, and two patients who were able to receive consolidation high-dose chemotherapy with stem cell transplant. If we turn to the other study, AFM13202, enrollment into the monotherapy study is now complete. More than 100 patients with relapsed or refractory peripheral T-cell lymphomas have received study treatment, and we expect, as Adi said, to report top-line data in the fourth quarter of 2022. The focus of this data release will be the overall response rate as assessed by blinded independent review committee and a preliminary assessment of duration of response, taking into account that the maturity of duration of response data will depend on the actual duration of these responses. In summary, we are very pleased with the continuing development of AFM 13. Let's now turn to AFM 24. And the clinical program is summarized on slide five. AFM24 is the next most advanced innate cell engager in our pipeline, benefiting from the learnings of AFM13. And AFM24 therefore is also studied according to our three-pronged development strategy. We presented data on the dose escalation up to 480 milligrams weekly as single agent at the recent AACR meeting. The data showed that the pharmacodynamic activity is present at doses of 160 milligrams and higher. Importantly, we also observed that the relevant pharmacodynamic parameters, like target-mediated elimination or CD16 receptor occupancy, as well as markers of NK cell activation, show a plateau between 320 and 480 milligrams. In the meantime, we have confirmed this finding with the data of the now fully enrolled 720 milligram cohort. Again, seeing no relevant increases in pharmacodynamic markers with higher doses. These findings confirm our decision to define 480 milligrams as a recommended phase two dose for the expansion cohorts. And as a consequence, the dose escalation part of the study has been finished, has been closed, and no higher doses will be investigated. As I said, we are continuing to enroll patients in the expansion phase of the monotherapy study at 480 milligrams. And these expansion cohorts include patients with renal cell carcinoma, non-small cell lung cancer with EGFR mutations, and colorectal cancer. We also continue to enroll patients in the dose escalation parts of the two combination studies, AFM24102 and AFM24103. In AFM24102, the combination with atezolizumab, Roche's anti-PD-L1 checkpoint inhibitor, we are now treating patients with non-small cell lung cancer with EGFR-wide type, gastric and gastroesophageal junction adenocarcinoma, and pancreatic, hepatocellular, and biliary tract cancers. In the second combination study, investigating the combination of AFM24 with autologous NK cells, SNK01, we are treating patients with non-small cell lung cancer, again, EGFRY type, squamous cell carcinomorphs, the head and neck, and colorectal cancer. Through the three ongoing studies, we will be evaluating safety and efficiency of AFN24 in nine indication-specific cohorts, with particular focus on non-small cell lung cancer, which is presented in all three studies, and colorectal cancer, which is represented in two of the three studies. As previously said, we expect to report initial data from these studies during the second half of 2022. In addition, as shown on slide six, at NK2022 held in mid-May, we presented an analysis of the longitudinal effects of AFM24 for dose levels up to 480 milligrams, confirming the mechanism of action of AFM24 on the innate immune system. There was an increase in Ki67, a proliferation marker in peripheral NK cells, and an induction of cytokines like TNF and interferon gamma over time. Importantly, and consistent with the pharmacodynamic data, these effects were more pronounced at higher dose levels of 160 milligrams and above. A novel finding was the data that suggested also an activation of the adaptive immune system may be happening by AFM24. The analysis showed activation of cytotoxic T cells in the periphery and infiltration of T cells into the tumor bed by immune histochemistry, suggesting stimulation of anti-cancer immunity beyond the innate immune system and the possible engagement of adaptive immune system. These data support the rationale of AFN24 as monotherapy and the two combinations that are currently underway in the separate phase 1 to A studies. There will be three trial in progress posters at the upcoming ASCO conference that will further present background information and the design of the different AFM24 studies for patients with advanced EGFR-expressing solid tumors. We invite you to review these at the conference and connect with us if you happen to be at the conference. For AFM28, our third wholly-owned innate cell engager targeting CD123, we expect to submit an IND later in June and to start the first in-human phase one study in the second half of the year. As summarized on slide seven, at NK2022 in May, we presented preclinical data demonstrating that AFM28 induces lysis of CD123 positive leukemic blasts of AML patients, and that it effectively kills CD123 positive tumor cells, either pre-complexed or co-administered with cryopreserved NK cells. This is an important finding, as it is the first time that we show data of AFM24 in combination with cryopreserved NK cells. This is very exciting as it presents a promise for a potential off-the-shelf therapy targeting leukemic blasts and leukemic stem cells in patients with AML and MDS. By combining AFM24 with adaptive NK cell therapy, it is by redirecting these allogeneic NK cells to CD123 positive tumor cells, We believe that AFM28 can induce the depths of response necessary to meaningfully improve outcomes in patients with AML and MDS. We plan to initiate a combination development with NK cells at the earliest possible time point as soon as adequate information about safety and tolerability of single-agent AFM28 is available. The optimal strategy to initiate combination development will need to be discussed with regulatory agencies, and further details will be provided at a later point in time. Finally, on AFM28, we recently announced that preclinical data will be presented in a poster session at the European Hematology Association Congress on June 10th in Vienna, Austria. This data will further summarize the preclinical proof of concept data and will demonstrate findings from our toxicology studies with AFM28. With this, I'll hand over the call to Angus, who will take you through the financials. Angus, please.
spk09: Thank you, Andreas. Balance sheet and income statement highlights are shown on slides eight and nine of the presentation. As a reminder, AFIMET's consolidated financial statements have been prepared in accordance with IFRS and issued by the International Accounting Standard Board, or IASB. The consolidated financial statements are presented in euros, which is the company's functional and presentational currency. Therefore, all financial numbers that I'll present on this call, unless otherwise noted, will be in euros. As of March 31, 2022, cash and cash equivalents totaled 169.9 million euros compared to 197.6 million euros on December 31, 2021. The pro forma cash position as of March 31, 2022, including net proceeds before offering expenses from the April 2022 underwritten public offering, would be approximately 257.5 million euros. Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents, including the proceeds from the April 2022 public offering, will support operations into mid-2024. Net cash used in operating activities for the quarter ended March 31, 2022, was 28.4 million euros, compared to 16 million euros for the quarter ended March 31, 2021. Included in our cash burn for the first quarter of 2022 was a milestone payment to MD Anderson for the initiation of the phase two portion of the AFM 13-104 trial, which was expensed in Q4 2021 and paid in Q1 2022. Total revenue for the quarter ended March 31st, 2022 with 8 million euros compared with 11.7 million euros for the quarter ended March 31st, 2021. Revenue predominantly relates to the Genentech and Roivant collaboration. Research and development expense increased by 61% from 11.4 million in the quarter ended March 31st, 2021 to 18.4 million euros for the quarter ended March 31st, 2022. R&D expenses increased primarily due to increased expenses associated with the development of ASM24 and the ASM28 program, an increase in costs associated with other early stage programs and R&D infrastructure and an increase in share based payment expense. General and administrative expenses increased 57% from 4.5 million euros in the quarter ended March 31st, 2021 to 7 million euros in the quarter ended March 31st, 2022. The increase predominantly relates to higher share based payment expenses and an increase in insurance premiums. Net finance income decreased by 91% from 5.5 million in the quarter ended March 31st, 2021 to 500,000 euros for the quarter ended March 31st, 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 euro during the year. Net loss for the quarter ended March 31st, 2022 with 16.7 million euros or 14 cents per common share compared with net income of 1.4 million euros or one cent per common share for the quarter ended March 31st, 2021. Weighted number of common shares outstanding for the quarter ended March 31st, 2022. with $123.4 million. Additional information regarding these results is included in the notes to the Consolidated Financial Statement as of March 31st, 2022, which will be included in AFMED's filings with the U.S. Securities and Exchange Commission. We'll now turn the call back to Adi for closing remarks. Adi? Yeah, thanks a lot, Angus.
spk13: So we're almost halfway through the year, and We're very happy with the progress that we could make despite all the challenges out there. And as we've shown, we're progressing now three wholly-owned programs, AFEM 13, 24, and 28. All of them address major medical needs. And with our three-pronged strategy, we have developed something that indeed can raise hopes within these patients. As we're now showing on slide 10, there are a lot more meaningful updates planned for the second half of this year and on all three programs. Most importantly, we extended our cash runway into mid-2024, which enables us to reach these key inflection points for all our in-and-out engages. With that, I'd like to thank you all for your continued support of our work. I'd like to thank patients and their families who entrust us with the care of loved family members And for our employees in the US and Europe who are continuing to do the best they can in helping us to achieve our goal of bringing these innovative and differentiated treatments to patients who need them. We're now ready to take your questions. Thank you.
spk05: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Diana Graybush with SVB Securities. Your line is open.
spk06: Hi. Thank you for the question. One for me on the NK cell combination of AFM13. I wonder if you could talk as we're getting closer about the questions that you plan to ask FDA in your 2022 meeting. And then a second question is, can you talk about any differences or unique questions that you're focused on in the collaborations on NK cell development of RTIVA, NKGEN, and MD Anderson?
spk13: Yeah, thank you, Dana. I'm going to start out on that. So in terms of questions for FDA, we're compiling those because the study, which is ongoing with MD Anderson, does deliver important additional information. And so we have given you this snapshot now in ACR, where we have now treated in total 20 patients, close to 20 patients, and have seen this high response rate. But as I said, we have just completed a second cycle and now able to add a third cycle. So there's more to learn in particular on durability, which indeed already looks very promising. So all these elements contribute then to the a strategy that we will discuss with the FDA in order to take A from 13 forward. With that, I'll hand over to Andreas and see how he can answer your questions.
spk11: I cannot add significantly more. From the clinical side, as Adi said, we are gathering more experience with more patients, more follow-up, which clearly will frame our discussions focus from the clinical part clearly will be on accelerated approval pathways as we believe that this is a treatment that needs to come to patients as soon as possible. And as we have addressed also previously, of course, there will be some discussions on the NK cell and then CMC, which is normal for an FDA meeting. But we are bringing all this together and then preparing for this meeting.
spk13: And just to add on to your other questions relating to our collaborators, we're in close interactions with all of them. In the case of AFIM-13, we focused on an allogeneic encasal product cryopreserve that is planned to be a developing combination, as I said, with AFIM-13. And here, I cannot give you any further update at this stage as they are just a work in progress that we're conducting. We've made significant progress with many of our collaborators. I've received great support from them. We're indeed quite confident that we can take such an in-case of product preserved that's also produced in reasonable quantities so that eventually it's not just used for the Kennedy grade, for Kennedy material, but also for commercial materials. So that's the focus of our dialogues, that we go beyond just looking at the clinical study, but really have our focus on being able to execute this commercially. And that's the dialogues that we're having with some of these parties.
spk06: Maybe one follow-up for me on something you said in answer to the first question, Adi. I know we started with two cycles with this MD Anderson study, and then I think last year you were talking about up to six cycles and then I picked up that maybe you were talking four cycles around ACR and just now I heard you say three. So I wonder what the final protocol is for how many cycles you'll give the patients and what's been behind sort of that optimization of the number of cycles.
spk13: Yeah, sorry for that. I said three because we are now treating patients with the third cycle. But it's four cycles. This is correct, Andrea.
spk11: Yeah, we can go up to four cycles. In individual patients, we could, on an individual basis, even give cycles beyond four. But I think four for now is a good number.
spk05: Thank you. Thank you. Our next question comes from Kripa Devorakonda with Truist Securities. Your line is now open. Kripa Yulan is now open.
spk10: Sorry about that. Thank you so much for taking my question and congrats on all the progress through this year. I just wanted to follow up on Dana's question. The multiple cycles that you're giving patients, is there a better sense of what the duration between the treatment cycles is going to be. There was a range that you presented. When you go to the FDA, how much clarity would you need to have as to what the duration between the cycles needs to be? And in terms of data expectations for the data update from the combination, can you help set expectations as to what data we can expect? What level of maturity in terms of durability? And how much more do you need? You talked, Adi, about how you're going to have data from more patients. You're collecting more clinical data. But how much data do you think you need before you talk to the FDA for a path forward for the combination? Thank you.
spk13: Yeah, quite good questions. Andres?
spk11: Yeah, so in terms of interval between cycles, again, this is one of the open topics that we really would like to discuss with FDA. As you have seen, MD Anderson there initially has been quite a variability, which was in part due to some logistic reasons, patient planning. So I think we are now getting much better to a standardized approach. sequence of cycles where usually we will probably have, it's hard to say, maybe 28 to 56 days between cycles. But again, there may be some variation here. And this is a topic that we definitely want to discuss with FDA. Now, in terms of how much additional data we need, again, what we have said is that We want to discuss both aspects of a potential trial, which would be the clinical part as well as the NK cell part, the CMC part. As Adi said, we are making well progress in identifying NK cell sources. So this will also be a gating factor for our interactions with the FDA. Great.
spk10: Thank you so much.
spk11: Hope this answers your questions.
spk10: Yeah. Thank you.
spk05: Thank you. Our next question comes from Maury Raycroft with Jefferies. Your line is now open.
spk01: Hi. Congrats on the progress, and thanks for taking my questions. I have a quick follow-up on the combo as well. Just wanted to clarify if you're giving additional cycles to patients who are in a complete response, or is it primarily to patients who are not in a complete response? I guess I'm wondering if you're giving additional cycles as a maintenance dose Maybe if you can talk a little bit more about that.
spk11: Yeah, so again, this is something where we gather experience. Our policy has been to give additional cycles also for patients who are in a complete response, at least one additional cycle, if you will, as a kind of consolidation. In patients who go more slowly into a response, like we have seen increase in in quality of responses. Again, the primary goal is to get a patient into a complete response and then to probably get at least one consolidation cycle in.
spk01: Got it. Okay, that's helpful. And then for the AFM13 monotherapy study, are you waiting to see the data before starting a confirmatory phase three? And when do you anticipate speaking with FDA regarding the confirmatory study?
spk11: Oh, yeah, as we said, we expect the high-level data in the fourth quarter. And, of course, these data will trigger all of the subsequent events. We have some plans how a confirmatory study could look like, and we will take those plans to the FDA. probably at the time when we see the high-level data.
spk01: Okay, got it. And maybe last question, just for the increase in T cells that you're seeing in the tumor biopsies after AFM24 treatment, have you quantified that, and do you see any dose-dependent response there or relationship with that clinical benefit?
spk11: That's a good question, and these data are very, very new. We are currently in the process to analyze this obvious question, the correlation with clinical outcome, but we don't have the full data set yet, but we'll give updates in the future.
spk01: Got it. Okay, thank you for taking my question.
spk05: Thank you. Our next question comes from Lee Wassett with Cantor. Your line is now open. Hey, guys.
spk07: Thanks for taking my questions, I guess. I wanted to ask about AFM28. I know one of your peers showed some interesting data of CAR and KEM. I'm just curious if you have any thoughts there. Do you think there is any reason to your program? And also, where do you see the bar for success?
spk13: Andreas, you want to take that? So I guess you're referring to the data that were recently published by NCARTA. But in general, I would say we have seen activity of NK cells that were coming from different sources. So we have seen activity of cells that were derived from peripheral cells that were derived from core blood cells. And most of those results clustered in the range of 30, 40 percent. In CARTA data, it initially looks somewhat higher, but obviously here the The end is still very small, so we're eagerly waiting for them to see more. What we know in general is that we can enhance the efficacy of in cases quite significantly through a 28% study. And I now hand over to Andreas in order to give you a little more insight from the clinical end.
spk11: Well, I think you almost answered the question completely. So one of the Rationals to really develop an ICE in AML-MDS is the demonstrated sensitivity of AML cells to NK cells. So this, I think, is an important building block. Now, what we have said is that we believe that CD16A, especially when it's activating like we do with the ICEs with a very high affinity, very tight binding, is probably the most potent way to activate NK cells. It also addresses problems with cells with very low target expression, where we have shown that we are largely independent of target or density of the target. So we believe that this is a very potent way to utilize the already demonstrated activity of NK cells in AML, but really to boost it to extend it to low-expressing cells, to extend it to leukemic stem cells, which do express CDR123, but do not express some of the other used targets. So this, I would say, adds to our confidence that AFM28 could be a very, very potent program. Okay, I just want...
spk07: I have a follow-up on AFM24. I know you've shown some interesting biomarker data from the phase one trial. So just wondering if you can expand a little on perhaps the NK cell infiltration into the tumors and how it might engage the adaptive immune system as well.
spk11: Yes, certainly. maybe aren't if it's a preclinical question. Yeah, sure.
spk14: Sure. Happy to do that. Yes. You know, um, thanks for the question, Lee. So we just discussed the T cells. I mean, how do we think the engagement of the adaptive immune system may happen? We don't have direct proof, but what we know of course from the cancer immunity cycle that we do engage in case cells we knew no by the destruction, of the tumor cells, a dance will be released, uh, activate the dripping cells. They move to the lymph nodes, activate T cells. So we feel that this is a, uh, apparently potent way to also activate the adaptive immune system. Obviously exciting because we, um, have always thought in earlier models that we see that to some extent and to now see it in the patients. no, we need to be careful. It's small numbers. We just discussed, we still want to correlate with clinical activity, but there clearly is a trend and we clearly, it's also shown on the poster, this one, um, one small cell lung cancer where you see, you know, from 120 to 580. So in some cases quite significant, not all, but some cases. Uh, so that's the mechanism of action. Um, We have also seen and reported in the poster, of course, activation of circulating CD8 T cells with Ki67, the potent proliferation and activation markers of the T cells, and other proof of the activation of circulating NK cells, also by measuring Ki67 as one of the examples. Does that answer your question? Yes.
spk05: Thank you.
spk04: Thank you.
spk05: Thank you. Our next question comes from Brad Canino with Stifel. Your line is now open.
spk08: Good morning. Based on how enrollment for AFM24 has progressed this year, can you expand on or I guess offer any expectations for the degree of data that could be presented this year? You know, have there been any of the three therapies or cancer types that have enrolled better Do you have a sense for the rough sample size? And I guess as well, will you be ready to make any go, no-go decisions at this update? I'm just wondering when you might be ready to narrow the nine-cohort approach. Thank you. Andrea?
spk11: I can take this. So, of course, enrollment differs between the three studies. The AFM24101 study, here we have three parallel cohorts open. We have identified the recommended phase two dose. We are seeing enrollment into all three cohorts. It's probably a little bit too early to say whether one cohort will be faster or quicker enrolling than the others, but we should have adequate numbers of patients in all three cohorts. Now, for AFM24102 and 103, we are a little bit earlier. As we have discussed, both studies have safety run-in phases where we start with lower doses of AFM24 to address some of the authority commands to look at safety, at least in the limited number of patients. Here, in both studies, we are in the dose escalation part So there will be mainly safety data that we will collect until the end of the year and activity data of the two combinations studies probably during first half of next year. Again, all these studies are open labels, so depending on the degree of activity, of course you can make decisions for further treatment or for discontinuation of certain cohorts. at every part of the enrollment process.
spk08: Appreciate it. Thank you.
spk05: Thank you. Our next question comes from Do Kim with Piper Sandler. Your line is open.
spk12: Hi. Thanks for taking my question. I was wondering if you could provide some additional details on the 700 20 milligram cohort for AFM24. Any differences in AEs that you saw between that dose and the 480 milligram dose? Any efficacy signals? That would be helpful. Thank you.
spk11: I can take this also. Again, the 720 milligrams, as I said, has been fully enrolled. We have not seen any dose-limiting toxicity, which is consistent with the other dose cohorts. We have not seen a change in the toxicity profile. And in accordance to our previous guidance, we are putting the data together and plan to submit more granular updates at one of the scientific meetings.
spk12: Okay. Got it. Question on AFM 13 monotherapy. If you do get accelerated approval, what are your initial thoughts on the size of the commercial infrastructure that you'll need? How big of a sales force? And does your cash guidance assume that you'll get approval and launch the product?
spk13: So the first question is on how big of a an entity would need to have to build in order to detail this product. We have not disclosed any details on that. And at the moment, the company has not taken a final decision if we would detail the program as ultimate or if we would find a commercialization partner. So that's open. Having said that, we have built up a commercial team that is doing all the background work as we move along. So the work is full proceeding, and I just have to say at the moment, as we proceed, we haven't yet set a full timeline to this. But as we're proceeding, we can take the decision on which direction we're going to go if we partner or if we build up the commercial infrastructure on our own. Into this also plays the... the way how we proceed forward with AFM13 in combination with the natural killer cells, which we then want to detail in the second half. So this is an important milestone. And I would say that once we have all that together, so the AFM13 monotherapy data and how we can proceed with the combination of NK cells, then we can take this detailed step forward in order how we want to commercialize AFM13.
spk12: Okay, thank you very much.
spk05: Thank you. Our next question comes from Yelei Jin with Laidlock and Company. Your line is open.
spk15: Good morning and thanks for taking the questions. The first question just tacked on the previous one that in terms of the nine cohorts for the AM24, was there a minimum number of patients which could be different in different indications? you need to have to make the initial assessment, then I have a follow-up. Andreas?
spk11: Yes, we have discussed, I think, also when we presented the studies, all studies are basically built as assignment two stage designs, and of course the target response rate vary a little bit, but What I would say is if you assume like 10 patients plus minus two or so for the first interim analysis and to make a first go-no-go decision, I think that gives you a reasonable ballpark how the design is laid behind these cohorts. And then of course if you meet your success criteria, each cohort has the potential to go up to 35 to 40 patients. which we believe would also be a critical number of patients to engage into meaningful discussions with FDA. But as I said, we have this first look at roughly 10 patients per cohort.
spk15: Okay, great. That's very, very helpful. And maybe just another follow-up question here, which is that given AFM28, it's already, you know, ready for the clinical study at the moment. Question is that if you compare it 28 versus the 13, both under the hemo space. Do you see any differences besides the indication or the targets that, you know, improve from the 13 or any other colors on that? And thanks.
spk11: Yeah, that's a question for Arndt.
spk14: Yeah, thanks for the question. You know, a few details we can share. First, when you compare it to 13, Of course, 28 is now more the IgG-like molecule with longer half-life. What hasn't changed is, I think, the differentiation potential that Andreas already listed. What we see and share on the poster is very specific killing, CD123 positive cells, sparing of the progenitor cells that are CD123 negative, very strong activation of NK cells, superior to the Fc-enhanced antibody, so basically a telekertuzumab. So what we're seeing across the board is preclinically so far that the strategy works out where we really strongly believe with our ICE technology we can surpass activity seen with prior CD123 antibodies.
spk15: Okay, great. That's very helpful. Appreciate the color, and thanks a lot, and congrats on the progress.
spk05: Thank you. Our next question comes from Nick Abbott with Wells Fargo. Your line is now open.
spk02: Good morning. Thanks for taking our questions. Congratulations on all the progress. First one from me. So for AFM 13 plus NK cells, do you intend to file for breakthrough therapy designation before meeting with FDA?
spk13: Regulatory? What's that?
spk04: We would not apply for breakthrough designation before we talked to the agency with that program. We decided to first talk to the agency and discuss the data. And as Andreas mentioned before, from a clinical and also CMC perspective, then we take it from there.
spk02: Okay, thanks. And then at that meeting, Would you be presenting FDA with a registration-directed trial plan, including CMC, or is it more here are the pieces, how do we put it together into a registration-directed trial?
spk13: No, no, what's that?
spk04: Thank you. Our current thinking is that we put that all together, both the clinical perspective, but also the CMC perspective. And we all know how important it is to have the CMC process in place. And therefore, this needs to go together from our perspective.
spk02: So just to be clear, then, you would be proposing here is our plan.
spk04: Could you please repeat, Nick? I didn't get it.
spk02: Yes, sorry, Wolfgang. I'm saying just to be clear, then, you would go to FDA with a registration plan? Yes. Okay, great. Thank you very much.
spk05: Thank you. As a reminder, ladies and gentlemen, that's star one to ask your question. And I'm currently showing no further questions at this time. Thank you for joining AlphaMed's first quarter 2020 earnings business and business update conference call. This concludes the conference. You may now disconnect. Everyone have a wonderful day.
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