Affimed Q3 2023 Earnings Report $0.63 +0.00 (+0.16%) Closing price 04/10/2025 04:00 PM EasternExtended Trading$0.68 +0.05 (+7.83%) As of 07:38 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Affimed EPS ResultsActual EPS-$1.70Consensus EPS -$2.10Beat/MissBeat by +$0.40One Year Ago EPSN/AAffimed Revenue ResultsActual Revenue$2.14 millionExpected Revenue$1.82 millionBeat/MissBeat by +$320.00 thousandYoY Revenue GrowthN/AAffimed Announcement DetailsQuarterQ3 2023Date11/14/2023TimeN/AConference Call DateTuesday, November 14, 2023Conference Call Time8:30AM ETUpcoming EarningsAffimed's Q4 2024 earnings is scheduled for Wednesday, June 11, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Earnings HistoryAFMD ProfileSlide DeckFull Screen Slide DeckPowered by Affimed Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 14, 2023 ShareLink copied to clipboard.There are 14 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to Affimed Envy's Third Quarter 2023 Earnings and Business Update Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Alex Fudikidis, Head of Investor Relations. Operator00:00:36Please begin, sir. Speaker 100:00:38Thank you, Norma, and thank you all for joining us today for our Q3 2023 update Before we begin, I'd like to remind everyone that we issued a relevant press release earlier today, which can be found on the Investor Relations Including Adi Hoss, our Chief Executive Officer Andreas Hartstrek, our Chief Medical Officer Arndt Hiliars, our Chief Scientific Officer, Wolfgang Fischer, our Chief Operating Officer and Angus Smith, our Chief Financial Officer. The team will be available for Q and 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 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 statements, 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. Speaker 100:02:24With that, I'll turn the call over to Adi. Adi? Speaker 200:02:29Thank you, Alex. Good day, everyone, and thanks a lot for joining us today also from my side. We have entered a very important An exciting phase for us to meet our investors and patients that do require novel options in order to prolong their lives So that they can spend more time with their families and friends. We have been progressing well with all 3 clinical programs And are now in a period where we plan to report data frequently over the next weeks months. Moving to Slide 5. Speaker 200:03:05We recently announced that the new name for ASM13 will be a symptomic. The symptomic It's developed in combination with Arteva's Allo NK product in the Luminide 2 or 3 study. We're now actively recruiting Hodgkin lymphoma in patient luminize 2 or 3 and Preparing to report the efficacy and safety data from the study in the first half of the year. As a reminder, during this phase of this study, we will be treating 24 patients with Hodgkin lymphoma in 4 cohorts. And all these cohorts will use active doses of asymptomatic and AlloINK. Speaker 200:03:50In addition, our interactions with the FDA have been very productive. In September, we announced that we received fast And today, we announced that we received positive feedback from the FDA in their responses for our Type C meeting, which Andreas will discuss in just a moment. But from the FDA's written responses, we believe that the Luminoid 2 or 3 study Based on FDA's feedback and guidelines puts us in a very good position to pursue accelerated approval. The LUMINI-two zero three study builds on the unprecedented results observed in AFM13-one hundred and four. We investigate the sponsored clinical trial we have been running in collaboration with Andy Anderson. Speaker 200:04:42Updated data from that will be presented by Doctor. Iago Nieto, the lead investigator at the ASH Meeting Annual Meeting 2023 on December 11. Affimed will host a dedicated call for the financial community to provide an in-depth insight Into this important update, which will include longer follow-up data. Now turning to AFM24. We remain on track to provide An update on the first three expansion cohorts from the combination study of AFM24 with atezolizumab in December. Speaker 200:05:21This combination is based on findings that AFM24 activates both innate and adaptive immune cells. And the idea now is to enhance efficacy by combining AFM24 with atezolizumab. As a reminder, we already have seen that our innate cell engager asymptomatic in combination with PD-one is able During the Q3, we also initiated enrollment in the North MOSA Lung Cancer EGFR mutant cohort and have begun treating patients. Again, as a reminder, agent 24 is a single agent, showed partial responses in durable stable diseases in this indication. Data from this expansion cohort is expected in the first half of twenty twenty four. Speaker 200:06:17And last, We continued to make good progress in our AFM28 monotherapy dose escalation. During the Q3, we completed treatment of patients in the 3rd dose cohort without any limiting and completed enrollment of patients in the 4th dose cohort, now administering a flat dose 25 milligram weekly. On Slide 6 and 7, we provide important background on the treatment of the indications we're targeting with LumineDazep203. In Hodgkin lymphoma, BV and PD-one checkpoint inhibitors have changed the way patients are treated. As these therapies move to earlier lines of therapy, a patient population With high unmet medical need has emerged, the BV and PD-one double refractory population. Speaker 200:07:19Now let me quickly talk about which therapies exist in general for relapsedrefractory Hodgkin lymphoma. For this patient population cytotoxic agents such as platinum chemo and bendamustine Or even targeted agents such as lenalidomide or mTOR inhibitors are listed in the NCCN guidelines. But it's important to note that these therapies were studied in relapsedrefractory Hodgkin patients before the introduction of PV and checkpoint inhibitors. And limited information is available on their efficacy on in the double refractory population. But even still, they are correct or right below the R8 and full period. Speaker 200:08:07We believe this is where asymptomatic plus NK cell therapy has the potential to transform the treatment landscape for double refractory patients. The response rates reported from AFM13104 are outstanding and in particular the CR rate of 70 plus percent is higher than the CR rate of other treatments even in less heavily pre treatment. And as next month, we'll provide A definite view on the duration of response and event free survival for the therapy for HHL patients treated at the recommended phase. Luminized-two zero three further includes relapsedrefractory PTCL patients. PTCL has a very high need with more than half of patients moving to second line, which now offers only agents with limited efficacy and still no full approval. Speaker 200:09:07Based on our market results, we believe the market opportunity for a symptomatic plus NK cells in double refractory Hodgkin lymphoma alone is in excess of €1,000,000,000 And with the inclusion of second line relapsedrefractory PTCL, this would increase to over €3,000,000,000 combined. Finally, during the quarter, we saw a significant reduction in our operating cash burn, as compared to the 1st 2 quarters of the year, With that, I'll turn the call over to Andreas, who will provide additional insights on the progress we're making in our pipeline. Andrea? Speaker 300:09:55Yes. Thank you, Adi, and also welcome from my side to everyone on the phone. I would like to start my clinical overview with our progress that we made with AFM13, As Adi said, now called asymptomatic going forward. We are pleased to update you on the progress that we have made Regarding the development of asymptomatic in combination with ALLO and K or as it also known AB-one hundred and one from Arteva. After receiving the clearance from FDA to proceed with the initiation of the Phase 2 clinical trial earlier this year, We made significant progress towards our goal of getting the study up and running, and we now have the first sites open, and we are actively recruiting patients. Speaker 300:10:47Furthermore, as shown on Slide 9, In September, we received Fast Track designation for asymptomatic. And in October, we got a written feedback from FDA On our Type C meeting request, on Slide 10, we show the updated Luminize study design. In accordance with FDA's feedback, we will now add a cohort to the LUMINIZE-two zero three trial, which will treat patients with relapsed or refractory Hodgkin's lymphoma with LONK plus IL-two only. This will address the contribution of individual components in the combination. This cohort will be designed as an observation cohort with the option available to patients to cross over to the combination with the symptomatic if they don't show a response to their initial treatment. Speaker 300:11:47We believe that the study, which was designed based on FDA's recommendation and guidelines, puts us on track for regulatory approval pending the final assessment of the magnitude of clinical benefit. We are very encouraged with the outcome of the FDA interactions and look forward to continuing our discussions with the agency as we are generating data from the study. As announced, we expect to report initial safety and efficacy data from this trial during the first half of twenty twenty four. In addition, as Adi mentioned, Doctor. Yagun Yeko, the lead investigator of the original study that investigated the combination of asymptomatic with cord blood derived NK cells at MD Anderson Cancer Center. Speaker 300:12:37We present updated data in an oral presentation at the ASH 2023 Annual Meeting on December 11. The abstract for the presentation was published earlier this month. As shown on Slide 11, At the cutoff date for the abstract, a total of 42 relapsedrefractory CD30 positive Hodgkin lymphoma and non Hodgkin lymphoma patients were enrolled in the study with 36 of these patients treated at the recommended Phase 2 dose. Important to mention that all patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment. Of note, All of the Hodgkin lymphoma patients were double refractory to BV and PD-one. Speaker 300:13:36The combination treatment achieved an overall response rate of 94.4% with a complete response rate of 72.2 The treatment regimen continues to demonstrate a good safety and tolerability profile With no cases of cytokine release syndrome, immune effector cell associated neurotoxicity or graft versus host disease of any grade. At the median follow-up of 14 months, The overall survival rate was 76% and the median overall survival has not been reached. An in-depth analysis included updated event free survival and overall survival data will be presented during Doctor. Nieto's oral presentation, including a comprehensive analysis of efficacy, durability and safety outcomes, demonstrating the potential of asymptomatic in combination with allogeneic and K cells. On the same day, Affimed plans to host an investor call to provide additional information about the status of the Luminize-two zero three study, the treatment landscape in Hodgkin lymphoma and peripheral T cell lymphoma and the respective market opportunities. Speaker 300:15:04Now let me turn to AFM24. As shown on Slide 12, In the ongoing study AFM24102, we are treating patients with AFM24 and atiselizumab. In the ongoing studies, the original 3 cohorts included patients with non small cell lung cancer, EGFR wild type, Gastric and gastricifer junction adenocarcinoma and pancreatic hepatocellular and biliary tract cancers respectively. Based on the promising activity seen with AFM24 in our monotherapy study, We added also a cohort for EGFR mutant non small cell lung cancer patients that is now actively treating patients. We believe that AFM24's role in activating the immune system by specifically triggering NK cells and macrophages can be processed by macrophages and dendritic cells with the possibility to activate tumor reactive T cells. Speaker 300:16:19The combination of AFM24, which activates the innate immune system with a tislelizumab, which impacts the adaptive immune system, therefore has in our opinion a very good logical rationale. As Eddie mentioned, we will report data on the first three cohorts of 10 to 15 patients per cohort in December and we plan to report the data on the non small cell lung cancer EGFR mutant cohort in the first half of twenty twenty four. If we turn to AFM 28 On slide 13, we show the progress for our 3rd clinical program. AFM-twenty eight is targeting CD123 in acute myeloid In this program, we have completed treatment of patients in the 3rd dose cohort of our ongoing and dose escalation trial using a dose of 100 milligram flat once weekly. As mentioned, we have not seen any dose limiting toxicities at this dose cohort and we meanwhile have completed the enrollment of patients in dose Cohort for treating patients at 200 milligrams weekly. Speaker 300:17:36Now where do we go with AFM28? The first step is to complete the dose escalation study and to identify a safe recommended Phase 2 dose based on correlative science and initial clinical activity. After that for us there are 2 options, either to develop AFM28 as single agent or in combination with allogeneic and K cells. We are planning to provide the next progress update on this during the first half of next year. Thank you again for your attention. Speaker 300:18:10And with this, I will turn over the call to Angus to update you on the quarterly financial performance. Angus, please? Speaker 400:18:19Thank you, Andreas. Balance sheet and income statement highlights are shown on Slides 1516 of the presentation. A quick reminder that Appymed'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. Since our financials are described in detail in the press release we issued this morning, I will only provide highlights on this call. Speaker 400:18:47As of September 30, 2023, cash, cash equivalents and financial assets totaled €97,500,000 compared to €190,300,000 on December 31, 2022. Based on our current operating plan and assumptions, We anticipate that our cash and cash equivalents, along with our financial assets will support operations into 2025. Net cash used in operating activities for the quarter ended September 30, 2023 were €18,200,000 compared to €19,000,000 Importantly, our operating cash burn for the quarter reflected a 45% drop from the previous quarter and is reflective of our efforts to carefully manage our cash burn going forward. Cash flow from investing activities for the quarter reflects the fact We allocated a portion of our cash resources to short term government bonds during the quarter in an effort to diversify and get access to higher interest rates on our excess liquidity. Total revenue for the quarter ended September 30, 2023 was €2,000,000 compared with €14,900,000 for the quarter ended September 30, 2022. Speaker 400:19:58Total revenue predominantly relates to the Roybant and Genentech collaborations and the reduction as Compared to the prior year period is due to the fact that we have now completed our obligations under both collaborations and therefore recognized the significant majority of the associated revenue. We remain eligible for future milestone payments under both collaborations based on the advancement of the licensed molecules, which is at the discretion of our partners. I will now turn the call back to Adi for closing remarks. Adi? Speaker 200:20:25Thank you, Angus. Let's move to Slide 18. Here you see the details of our upcoming milestones for all our programs. As is that in my intro, We have entered a very important and exciting phase for us at Affimed, our investors And in particular patients that do require novel options in order to prolong their lives to be able to spend more time With their families and friends. We have been progressing well with all our 3 clinical programs and are in this period where we plan to frequently Thank you all for your continued support We're now ready to take questions. Speaker 200:21:25Operator? Operator00:21:27Thank you. Please stand by while we compile the Q and A roster. One moment for our first question please. Our first question comes from the line of Maury Raycroft of Jefferies. Your line is now open. Speaker 500:21:53Hi, this is James on for Morrie. Congratulations on the progress and thank you for taking the questions. For the Type C meeting, did the FDA provide Any more specifics on the magnitude of clinical benefit? And do they seem more focused on ORR or durability measures? And then after that, I have a quick follow on. Speaker 200:22:13Andreas, do you want to take that question please? Speaker 300:22:17Yes, I can take it or Wolfgang, who I think is also on the line, but I can probably start. So no, as you may know, when you talk with FDA, they will never give you a fixed number of what they consider It's a meaningful magnitude of effect. However, when we look at the landscape and when we talk 2 key opinion leaders and we have done quite a number of interviews right now. I think the consensus seems to focus on 50% Response rate or higher with the majority of responses being complete responses. And when you look at time related factors, I think it's probably duration of or even progression free survival of 6 months or longer for these very heavily pretreated Patience. Speaker 300:23:07Now again, I have to stress this is more feedback from key opinion leaders. FDA will always tell you it's a review issue. And we expect that FDA will look both at overall response rate as well as time related factors like either duration of response or event or progression free Survival. I hope this addresses your question. Speaker 500:23:30Yes, that's helpful. And the second question is, how many patients and follow-up do you need to adequately address the contribution of single Components in the Allo NK IL-two core that you reported today? Speaker 300:23:45Again, that is a question that Basic or probably will be answered by the data. We expect that the response rate for the non targeted And Keesel will be relatively low. So we will see or we expect to see already a very significant differences in the response rates, which Clearly, we'll diminish the importance of long term follow-up if you only have a couple of responses Compared to response rate, which is in excess of 50%, 60%, I think the magnitude of differences would be sufficient. Speaker 500:24:23So how many patients do you think you would need? Speaker 300:24:27Again, this is something that we will discuss Further with FDA, the initial design is somewhere between 10 20 patients. Speaker 500:24:38Great. Thank you so much for answering my question. I'll hop back in the queue. Operator00:24:43Thank you. One moment for our next question please. Our next question comes from the line of Shri Rupa Devarukonda with Chorus Securities. Your line is now open. Speaker 600:24:56Great. Hey, guys. Thank you so much. I have actually a follow-up on the previous question. Just to confirm, were there any changes to the protocol that the FDA asked for just broadly? Speaker 600:25:09And also based on this the Type C meeting, Can you move ahead with part 2 of the study or following part 1, is there any need to Meet with the FDA again. I know you guys have you can have multiple meetings with the FDA given your designation, Fast Track Speaker 700:25:37I can take it. Hi. So the first question whether there have been changes to the protocol We requested by the FDA, the answer is no. But as Andreas mentioned before, we are going to add this 1 cohort Alo and K cells alone, that's the first question. And the second question, there is no need for us to go back or consult with the FDA to So that means we can proceed from the beginning to the end as approved by the FDA. Speaker 600:26:12Got it. And also just another clarification, is this, Allo and KL2 cohort needed For accelerated approval submission? Speaker 700:26:27When we spoke to the FDA during IND Process and also during Type C, right, the contribution of single components is important to the agency. And therefore, the assumption is, yes, this is something which we need to get accelerated approval. Speaker 600:26:46Great. Thank you so much. Speaker 700:26:48You're welcome. Operator00:26:49Thank you. One moment for our next question please. Our next question comes from the line of Lee Wasek with Cantor Fitzgerald. Your line is now open. Speaker 800:27:01Hey, thanks for taking my questions. Maybe just a follow-up For the new NK cohort, can you just clarify, do these patients need to Progress before they can crossover, maybe just a little more color on the criteria for crossover. And then can you count these patients in the total and to support the efficacy as well? Speaker 200:27:31Wolfgang, you want to take that? Speaker 700:27:34Yes. I can take that question. Yes. These patients, right, when treated with LONK IL-two, if they are not responding, That means if they are not showing a partial response or a complete response, they will have the opportunity to cross over to the combination treatment. Now this brings me to your second question, whether these patients then could go crossover into the analysis cohort For the primary endpoint, and the answer is no, because there could be a bias. Speaker 700:28:10So what we are having, right, is that we say They came crossover to the combination treatment and will be treated, but not be part of this analysis for the primary endpoint. Speaker 800:28:23Okay, got it. And then you mentioned earlier you had the 1st site open enrolling patients. Just can you give us some sense in terms of how many sites do you need to fully enroll the run-in portion? Speaker 700:28:40Andreas, do you want to go ahead and answer the question? Speaker 300:28:46Yes. I mean for the run-in portion, as you know, there is somewhat of a staggered approach, especially for the first three patients per cohort. So our current assumption is that we probably need 5 to 6 good recruiting sites for the initial For cohorts and then we will bring more sites on board as the study progresses or continues. But we are in active process to add sites. But as we said, we are on track to provide the Initial safety and efficacy data are first half of twenty twenty four. Speaker 800:29:26Okay. Thank you. Operator00:29:29Thank you. One moment for our next question please. Our next question comes from the line of Diana Graybosch with Leerink Partners, your line is now open. Speaker 900:29:41Thanks. Two questions from me. One on the new AB-one hundred and one arm. I think you had known that it was a possibility that FDA would want an arm like this for contribution of components. But initially my understanding is, didn't include it in the design because KOL feedback that they were hesitant to enroll patients into such an arm Given the preclinical data suggesting NK Cells alone wouldn't have benefit, I wonder how have your conversations gone with KOLs and sites and What can you do to ensure enrollment into this arm and enrollment overall to this study now that this arm is a possibility? Speaker 900:30:22And then my second question is on AFM24. And there's been particularly in EGFR mutant lung cancer, but also across your indications, a lot of interesting data with antibody drug conjugates. And I wonder whether there's potential down the road after you show benefits that combine with chemotherapy and if you're considering that in the form of an ADC going forward? Thank you. Speaker 300:30:53Andreas, you can take both questions. So, yes, so the LONK IL-two arm, as you mentioned, It's an arm that we added also after discussion with some of our clinical advisory opinion leaders. Probably the only way to make such an arm, recruiting arm is what we implemented now that we give patients the options they do not have After cycle 1, they can immediately cross over to the combination treatment. So they will have the option to receive What we believe is a more active treatment. And again, as I said, we believe that the number of patients in this arm will be relatively small as we are Not expecting to see a very high response rate here. Speaker 300:31:45So this is, I think, a good compromise that most of our clinical sites believe It's acceptable to patients. If you would have an arm that has only alloNK cells without the option to crossover, I think you would have Quite significant challenges to recruit in such an arm. As for AFM24, yes, we have a number of indications, In the non small cell lung cancer field where we do see ADCs coming up and We believe that the mechanism of action of AFM24 could fit very well with ADCs. So Combination either with TKIs, for example, in the EGFR mutant field or with ADCs These both in the non small cell lung cancer EGFR wide app and EGFR mutant fields are definitely options that we would look at after we have completed our 102 study. Speaker 800:32:53Great. Thank you. Operator00:32:55Thank you. One moment for our next question please. Our next question comes from the line of Ynon Hu with Wells Fargo. Your line is now open. Speaker 1000:33:07Great. Thanks for the questions. Two questions on the AFM13 program. The first one is how is the infusions of the NK and AFM13 Handled on the day of infusion. I was wondering, since this is not a pretty complex product, Which component is infused first? Speaker 1000:33:35And what is the space of time between the 2 infusions? The second question is about how you select the 2 cohorts for Stage 2. Would that be based on 2 cohorts having to have the same NK component NK dose or having of these or these 2 cohorts having to have the same AFM13 dose Or it doesn't matter, just the 2 cohorts with the best performing ORR. Thank you. Speaker 200:34:11Andrea? Speaker 300:34:15Yes. So in terms of administration and how the trial country is designed, We start on the days where we give AFM13 our symptomatic and NK cells with the symptomatic infusion. Initial infusion duration is 4 hours for the 1st cycle, but with the option to reduce the duration of the infusion if No infusion related reactions. Then we have a 1 hour break and then we have the NK cell infusion, which usually It's a pretty short 15 to 30 minute infusion. This is based on the previous experience, especially with rituximab in B cell lymphomas were, I think, in all programs, rituximab was given first to allow some On distribution of rituximab throughout the body and then followed by the NK cells, which has quite well worked in the B cell field. Speaker 300:35:16So this is how the regimen would be handled. And the second question was around selection of the Appropriate cohort. Again, there is no pre specification. So we do not necessarily have to use the same cell dose or the same Asymptomatic dose in the 2 cohorts, we will do a good assessment or thorough assessment of the risk benefit profile, both looking at efficacy and safety. Based on that, we'll select the 2 most appropriate cohorts for the Part 2 of the study. Speaker 1000:35:52Great. Thank you. Operator00:35:56Thank you. One moment for our next question please. Our next question comes from the line of Brad Canino with Stifel. Your line is now open. Speaker 1100:36:07Hi. Thanks for the question. Speaker 1200:36:09I had a 2 parter. One of them was about your view on the durability when it comes to the Accelerate approval previously. So on top of that, I guess I want to ask, Do you expect the MD Anderson presentation, which I think will include the final follow-up for the 3 to 4 cycle patients To be a definitive demonstration of the durability of your potential commercial product or would you tell us to wait for the Luminosity-two zero three data to start rolling in? Thank you. Speaker 200:36:38Andrea? Speaker 300:36:42That's a very difficult question. I think what we will show at ASH is clearly an update of both EFS or PFS Survival and overall survival, I would not say this will be the final as we already indicated in the abstract. There are Still quite significant number of patients in follow-up, so there could be a further follow-up data with even longer duration of responses Or survival. Now how these data translate into the LUMINI study is a little bit more difficult to answer. We believe that The 104 study is a very good proof of concept study, which I think indicates the magnitude of clinical effect that you could expect Based on all our preclinical data, we have shown that the Allo NK cell is very active and the coadministration If it all trends to be even a little bit more potent than the pre complex thing, again, with a caveat that this is Preclinical data, but we believe that 104 is probably a very good indicator of what can be Speaker 700:37:59Thank you. Operator00:38:02Thank you. One moment for our next question please. Our next question comes from the line of Yulai Jen with Laidlaw and Company. Your line is now open. Speaker 1100:38:14Good morning and thanks for taking the question. You have introduced The concept or the phenomenon of double refractory patients. So my question is, Does the LUMIN-two zero three study only include patients with this Doesn't mention all this phenomena or you will have single refractory patients as well? Speaker 300:38:46No, I can take this. All patients that are recruited into Lumineis have to be double refractory. So The requirements is that they have at least failed 1 combination chemotherapy regimen, they have failed BV and they have failed PD-one. So if you will, it's more or less triple refractory, so chemotherapy refractory, PD-one refractory and BV refractory. So This is the patient population where we believe there's absolutely no medical alternative and these patients are in dire need for active treatment. Speaker 1100:39:20Okay. That's very helpful. And in terms of FMD Anderson studies with the Core blood cells. Most of the patients also being categorized into this category or There are some sort of single refractory patients. So I just wanted to get some sense of how to think about that data versus The future readout you have in first half of next year. Speaker 300:39:50Yes. So in the MD Anderson trial, The patients with Hodgkin lymphoma all fall into this category of double refractory. So all patients RBV and PD-one refractory. As you remember, we also had a very small group of Five patients of non Hodgkin lymphoma as PD-one is not approved for all non Hodgkin lymphomas. We have 2 patients in the non Hodgkin lymphoma cohort that have not been exposed to PD-one, but have been exposed to BV. Speaker 300:40:24But again, the core populations, the hot skin lymphoma population, all patients have been double refractory to BV and Speaker 1100:40:36Okay, great. That's very helpful and thanks and congrats on the progress. Operator00:40:43Thank you. One moment for our next question. Our next question comes from the line of Sean Lee with H. C. Wainwright. Operator00:40:58Your line is now open. Speaker 1300:41:01Good morning, guys, and thanks for taking my question. I was just wondering if you could provide a bit more color on What type of data can we expect from AFM24 at ASH? You mentioned you can expect the first three cohorts? Speaker 200:41:18Andrew? Speaker 300:41:20Sorry, I had a little bit of a disconnect. Can you repeat your question? Speaker 700:41:25Sure. I was just wondering if Speaker 1300:41:27you can provide a bit more color on the type of data that you can expect from ASH for AFM24 from the 1st 3 quarters, I think, as you mentioned? Speaker 300:41:39Yes. So AFM24 will not be at ASH, but will be a separate Disclosure of the data will happen in December. Now as we said, we have the 3 cohorts, which is EGFR, white titlonsmallcellungcancer, gastric cancer and then the basket cohort that was HCC pancreatic and biliary tract. And we have about 10 to 15, it varies a little bit from cohort to cohort responsive valuable patients where we will show Mainly response rates, I think it's too early to have a long term follow-up data as Many of these patients were recruited over the last 6 months, but we should have quite robust response data for these 3 cohorts. Speaker 500:42:25Got it. Thanks. Operator00:42:30Thank you. I am currently showing no further questions at this time. This concludes today's conference call. Thank you for your participation. You may now disconnect.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallAffimed Q3 202300:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsSlide DeckPress Release(8-K) Affimed Earnings HeadlinesStockNews.com Begins Coverage on Affimed (NASDAQ:AFMD)April 11 at 1:45 AM | americanbankingnews.comBrokerages Set Affimed (NASDAQ:AFMD) Target Price at $13.50April 6, 2025 | americanbankingnews.comHere’s How to Claim Your Stake in Elon’s Private Company, xAIEven though xAI is a private company, tech legend and angel investor Jeff Brown found a way for everyday folks like you… To partner with Elon on what he believes will be the biggest AI project of the century… Starting with as little as $500.April 11, 2025 | Brownstone Research (Ad)Affimed (NASDAQ:AFMD) Short Interest Down 14.9% in MarchApril 3, 2025 | americanbankingnews.comAffimed (NASDAQ:AFMD) Coverage Initiated by Analysts at StockNews.comApril 2, 2025 | americanbankingnews.comAffimed Announces Acceptance of AFM24 Abstract on Dose Optimization for Presentation at American Association for Cancer Research Annual MeetingMarch 25, 2025 | globenewswire.comSee More Affimed Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Affimed? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Affimed and other key companies, straight to your email. Email Address About AffimedAffimed (NASDAQ:AFMD) N.V., a clinical-stage biopharmaceutical company, focuses on discovering and developing cancer immunotherapies in the United States and Germany. The company's lead product candidates include AFM13 that has completed Phase 2 clinical trial for CD30-positive lymphoma, Phase Ib clinical trial for hodgkin lymphoma, and completed Phase IIb clinical study for peripheral T-cell lymphoma; AFM24, a tetravalent, bispecific epidermal growth factor receptor, and CD16A-binding innate cell engager, which is in Phase IIa clinical trial for the treatment of advanced cancers; and AFM28, an innate cell engager (ICE), which is in preclinical development for the treatment acute myeloid. It develops AFM32, an ICE candidate that is in preclinical development for the treatment of solid tumors. It has collaboration with Artiva Biotherapeutics to develop the combination of acimtamig and AlloNK; license and strategic collaboration agreement with Roivant Sciences Ltd. to develop and commercialize novel ICE molecules, including AFM32, in oncology; and strategic collaboration agreement with Genentech for the development of certain product candidates, which includes novel NK cell engager-based immunotherapeutics to treat multiple cancers. The company was formerly known as Affimed Therapeutics B.V. and changed its name to Affimed N.V. in October 2014. Affimed N.V. was founded in 2000 and is headquartered in Mannheim, Germany.View Affimed ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Why Analysts Boosted United Airlines Stock Ahead of EarningsLamb Weston Stock Rises, Earnings Provide Calm Amidst ChaosIntuitive Machines Gains After Earnings Beat, NASA Missions AheadCintas Delivers Earnings Beat, Signals More Growth AheadNike Stock Dips on Earnings: Analysts Weigh in on What’s NextAfter Massive Post Earnings Fall, Does Hope Remain for MongoDB?Semtech Rallies on Earnings Beat—Is There More Upside? 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There are 14 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to Affimed Envy's Third Quarter 2023 Earnings and Business Update Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Alex Fudikidis, Head of Investor Relations. Operator00:00:36Please begin, sir. Speaker 100:00:38Thank you, Norma, and thank you all for joining us today for our Q3 2023 update Before we begin, I'd like to remind everyone that we issued a relevant press release earlier today, which can be found on the Investor Relations Including Adi Hoss, our Chief Executive Officer Andreas Hartstrek, our Chief Medical Officer Arndt Hiliars, our Chief Scientific Officer, Wolfgang Fischer, our Chief Operating Officer and Angus Smith, our Chief Financial Officer. The team will be available for Q and 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 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 statements, 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. Speaker 100:02:24With that, I'll turn the call over to Adi. Adi? Speaker 200:02:29Thank you, Alex. Good day, everyone, and thanks a lot for joining us today also from my side. We have entered a very important An exciting phase for us to meet our investors and patients that do require novel options in order to prolong their lives So that they can spend more time with their families and friends. We have been progressing well with all 3 clinical programs And are now in a period where we plan to report data frequently over the next weeks months. Moving to Slide 5. Speaker 200:03:05We recently announced that the new name for ASM13 will be a symptomic. The symptomic It's developed in combination with Arteva's Allo NK product in the Luminide 2 or 3 study. We're now actively recruiting Hodgkin lymphoma in patient luminize 2 or 3 and Preparing to report the efficacy and safety data from the study in the first half of the year. As a reminder, during this phase of this study, we will be treating 24 patients with Hodgkin lymphoma in 4 cohorts. And all these cohorts will use active doses of asymptomatic and AlloINK. Speaker 200:03:50In addition, our interactions with the FDA have been very productive. In September, we announced that we received fast And today, we announced that we received positive feedback from the FDA in their responses for our Type C meeting, which Andreas will discuss in just a moment. But from the FDA's written responses, we believe that the Luminoid 2 or 3 study Based on FDA's feedback and guidelines puts us in a very good position to pursue accelerated approval. The LUMINI-two zero three study builds on the unprecedented results observed in AFM13-one hundred and four. We investigate the sponsored clinical trial we have been running in collaboration with Andy Anderson. Speaker 200:04:42Updated data from that will be presented by Doctor. Iago Nieto, the lead investigator at the ASH Meeting Annual Meeting 2023 on December 11. Affimed will host a dedicated call for the financial community to provide an in-depth insight Into this important update, which will include longer follow-up data. Now turning to AFM24. We remain on track to provide An update on the first three expansion cohorts from the combination study of AFM24 with atezolizumab in December. Speaker 200:05:21This combination is based on findings that AFM24 activates both innate and adaptive immune cells. And the idea now is to enhance efficacy by combining AFM24 with atezolizumab. As a reminder, we already have seen that our innate cell engager asymptomatic in combination with PD-one is able During the Q3, we also initiated enrollment in the North MOSA Lung Cancer EGFR mutant cohort and have begun treating patients. Again, as a reminder, agent 24 is a single agent, showed partial responses in durable stable diseases in this indication. Data from this expansion cohort is expected in the first half of twenty twenty four. Speaker 200:06:17And last, We continued to make good progress in our AFM28 monotherapy dose escalation. During the Q3, we completed treatment of patients in the 3rd dose cohort without any limiting and completed enrollment of patients in the 4th dose cohort, now administering a flat dose 25 milligram weekly. On Slide 6 and 7, we provide important background on the treatment of the indications we're targeting with LumineDazep203. In Hodgkin lymphoma, BV and PD-one checkpoint inhibitors have changed the way patients are treated. As these therapies move to earlier lines of therapy, a patient population With high unmet medical need has emerged, the BV and PD-one double refractory population. Speaker 200:07:19Now let me quickly talk about which therapies exist in general for relapsedrefractory Hodgkin lymphoma. For this patient population cytotoxic agents such as platinum chemo and bendamustine Or even targeted agents such as lenalidomide or mTOR inhibitors are listed in the NCCN guidelines. But it's important to note that these therapies were studied in relapsedrefractory Hodgkin patients before the introduction of PV and checkpoint inhibitors. And limited information is available on their efficacy on in the double refractory population. But even still, they are correct or right below the R8 and full period. Speaker 200:08:07We believe this is where asymptomatic plus NK cell therapy has the potential to transform the treatment landscape for double refractory patients. The response rates reported from AFM13104 are outstanding and in particular the CR rate of 70 plus percent is higher than the CR rate of other treatments even in less heavily pre treatment. And as next month, we'll provide A definite view on the duration of response and event free survival for the therapy for HHL patients treated at the recommended phase. Luminized-two zero three further includes relapsedrefractory PTCL patients. PTCL has a very high need with more than half of patients moving to second line, which now offers only agents with limited efficacy and still no full approval. Speaker 200:09:07Based on our market results, we believe the market opportunity for a symptomatic plus NK cells in double refractory Hodgkin lymphoma alone is in excess of €1,000,000,000 And with the inclusion of second line relapsedrefractory PTCL, this would increase to over €3,000,000,000 combined. Finally, during the quarter, we saw a significant reduction in our operating cash burn, as compared to the 1st 2 quarters of the year, With that, I'll turn the call over to Andreas, who will provide additional insights on the progress we're making in our pipeline. Andrea? Speaker 300:09:55Yes. Thank you, Adi, and also welcome from my side to everyone on the phone. I would like to start my clinical overview with our progress that we made with AFM13, As Adi said, now called asymptomatic going forward. We are pleased to update you on the progress that we have made Regarding the development of asymptomatic in combination with ALLO and K or as it also known AB-one hundred and one from Arteva. After receiving the clearance from FDA to proceed with the initiation of the Phase 2 clinical trial earlier this year, We made significant progress towards our goal of getting the study up and running, and we now have the first sites open, and we are actively recruiting patients. Speaker 300:10:47Furthermore, as shown on Slide 9, In September, we received Fast Track designation for asymptomatic. And in October, we got a written feedback from FDA On our Type C meeting request, on Slide 10, we show the updated Luminize study design. In accordance with FDA's feedback, we will now add a cohort to the LUMINIZE-two zero three trial, which will treat patients with relapsed or refractory Hodgkin's lymphoma with LONK plus IL-two only. This will address the contribution of individual components in the combination. This cohort will be designed as an observation cohort with the option available to patients to cross over to the combination with the symptomatic if they don't show a response to their initial treatment. Speaker 300:11:47We believe that the study, which was designed based on FDA's recommendation and guidelines, puts us on track for regulatory approval pending the final assessment of the magnitude of clinical benefit. We are very encouraged with the outcome of the FDA interactions and look forward to continuing our discussions with the agency as we are generating data from the study. As announced, we expect to report initial safety and efficacy data from this trial during the first half of twenty twenty four. In addition, as Adi mentioned, Doctor. Yagun Yeko, the lead investigator of the original study that investigated the combination of asymptomatic with cord blood derived NK cells at MD Anderson Cancer Center. Speaker 300:12:37We present updated data in an oral presentation at the ASH 2023 Annual Meeting on December 11. The abstract for the presentation was published earlier this month. As shown on Slide 11, At the cutoff date for the abstract, a total of 42 relapsedrefractory CD30 positive Hodgkin lymphoma and non Hodgkin lymphoma patients were enrolled in the study with 36 of these patients treated at the recommended Phase 2 dose. Important to mention that all patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment. Of note, All of the Hodgkin lymphoma patients were double refractory to BV and PD-one. Speaker 300:13:36The combination treatment achieved an overall response rate of 94.4% with a complete response rate of 72.2 The treatment regimen continues to demonstrate a good safety and tolerability profile With no cases of cytokine release syndrome, immune effector cell associated neurotoxicity or graft versus host disease of any grade. At the median follow-up of 14 months, The overall survival rate was 76% and the median overall survival has not been reached. An in-depth analysis included updated event free survival and overall survival data will be presented during Doctor. Nieto's oral presentation, including a comprehensive analysis of efficacy, durability and safety outcomes, demonstrating the potential of asymptomatic in combination with allogeneic and K cells. On the same day, Affimed plans to host an investor call to provide additional information about the status of the Luminize-two zero three study, the treatment landscape in Hodgkin lymphoma and peripheral T cell lymphoma and the respective market opportunities. Speaker 300:15:04Now let me turn to AFM24. As shown on Slide 12, In the ongoing study AFM24102, we are treating patients with AFM24 and atiselizumab. In the ongoing studies, the original 3 cohorts included patients with non small cell lung cancer, EGFR wild type, Gastric and gastricifer junction adenocarcinoma and pancreatic hepatocellular and biliary tract cancers respectively. Based on the promising activity seen with AFM24 in our monotherapy study, We added also a cohort for EGFR mutant non small cell lung cancer patients that is now actively treating patients. We believe that AFM24's role in activating the immune system by specifically triggering NK cells and macrophages can be processed by macrophages and dendritic cells with the possibility to activate tumor reactive T cells. Speaker 300:16:19The combination of AFM24, which activates the innate immune system with a tislelizumab, which impacts the adaptive immune system, therefore has in our opinion a very good logical rationale. As Eddie mentioned, we will report data on the first three cohorts of 10 to 15 patients per cohort in December and we plan to report the data on the non small cell lung cancer EGFR mutant cohort in the first half of twenty twenty four. If we turn to AFM 28 On slide 13, we show the progress for our 3rd clinical program. AFM-twenty eight is targeting CD123 in acute myeloid In this program, we have completed treatment of patients in the 3rd dose cohort of our ongoing and dose escalation trial using a dose of 100 milligram flat once weekly. As mentioned, we have not seen any dose limiting toxicities at this dose cohort and we meanwhile have completed the enrollment of patients in dose Cohort for treating patients at 200 milligrams weekly. Speaker 300:17:36Now where do we go with AFM28? The first step is to complete the dose escalation study and to identify a safe recommended Phase 2 dose based on correlative science and initial clinical activity. After that for us there are 2 options, either to develop AFM28 as single agent or in combination with allogeneic and K cells. We are planning to provide the next progress update on this during the first half of next year. Thank you again for your attention. Speaker 300:18:10And with this, I will turn over the call to Angus to update you on the quarterly financial performance. Angus, please? Speaker 400:18:19Thank you, Andreas. Balance sheet and income statement highlights are shown on Slides 1516 of the presentation. A quick reminder that Appymed'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. Since our financials are described in detail in the press release we issued this morning, I will only provide highlights on this call. Speaker 400:18:47As of September 30, 2023, cash, cash equivalents and financial assets totaled €97,500,000 compared to €190,300,000 on December 31, 2022. Based on our current operating plan and assumptions, We anticipate that our cash and cash equivalents, along with our financial assets will support operations into 2025. Net cash used in operating activities for the quarter ended September 30, 2023 were €18,200,000 compared to €19,000,000 Importantly, our operating cash burn for the quarter reflected a 45% drop from the previous quarter and is reflective of our efforts to carefully manage our cash burn going forward. Cash flow from investing activities for the quarter reflects the fact We allocated a portion of our cash resources to short term government bonds during the quarter in an effort to diversify and get access to higher interest rates on our excess liquidity. Total revenue for the quarter ended September 30, 2023 was €2,000,000 compared with €14,900,000 for the quarter ended September 30, 2022. Speaker 400:19:58Total revenue predominantly relates to the Roybant and Genentech collaborations and the reduction as Compared to the prior year period is due to the fact that we have now completed our obligations under both collaborations and therefore recognized the significant majority of the associated revenue. We remain eligible for future milestone payments under both collaborations based on the advancement of the licensed molecules, which is at the discretion of our partners. I will now turn the call back to Adi for closing remarks. Adi? Speaker 200:20:25Thank you, Angus. Let's move to Slide 18. Here you see the details of our upcoming milestones for all our programs. As is that in my intro, We have entered a very important and exciting phase for us at Affimed, our investors And in particular patients that do require novel options in order to prolong their lives to be able to spend more time With their families and friends. We have been progressing well with all our 3 clinical programs and are in this period where we plan to frequently Thank you all for your continued support We're now ready to take questions. Speaker 200:21:25Operator? Operator00:21:27Thank you. Please stand by while we compile the Q and A roster. One moment for our first question please. Our first question comes from the line of Maury Raycroft of Jefferies. Your line is now open. Speaker 500:21:53Hi, this is James on for Morrie. Congratulations on the progress and thank you for taking the questions. For the Type C meeting, did the FDA provide Any more specifics on the magnitude of clinical benefit? And do they seem more focused on ORR or durability measures? And then after that, I have a quick follow on. Speaker 200:22:13Andreas, do you want to take that question please? Speaker 300:22:17Yes, I can take it or Wolfgang, who I think is also on the line, but I can probably start. So no, as you may know, when you talk with FDA, they will never give you a fixed number of what they consider It's a meaningful magnitude of effect. However, when we look at the landscape and when we talk 2 key opinion leaders and we have done quite a number of interviews right now. I think the consensus seems to focus on 50% Response rate or higher with the majority of responses being complete responses. And when you look at time related factors, I think it's probably duration of or even progression free survival of 6 months or longer for these very heavily pretreated Patience. Speaker 300:23:07Now again, I have to stress this is more feedback from key opinion leaders. FDA will always tell you it's a review issue. And we expect that FDA will look both at overall response rate as well as time related factors like either duration of response or event or progression free Survival. I hope this addresses your question. Speaker 500:23:30Yes, that's helpful. And the second question is, how many patients and follow-up do you need to adequately address the contribution of single Components in the Allo NK IL-two core that you reported today? Speaker 300:23:45Again, that is a question that Basic or probably will be answered by the data. We expect that the response rate for the non targeted And Keesel will be relatively low. So we will see or we expect to see already a very significant differences in the response rates, which Clearly, we'll diminish the importance of long term follow-up if you only have a couple of responses Compared to response rate, which is in excess of 50%, 60%, I think the magnitude of differences would be sufficient. Speaker 500:24:23So how many patients do you think you would need? Speaker 300:24:27Again, this is something that we will discuss Further with FDA, the initial design is somewhere between 10 20 patients. Speaker 500:24:38Great. Thank you so much for answering my question. I'll hop back in the queue. Operator00:24:43Thank you. One moment for our next question please. Our next question comes from the line of Shri Rupa Devarukonda with Chorus Securities. Your line is now open. Speaker 600:24:56Great. Hey, guys. Thank you so much. I have actually a follow-up on the previous question. Just to confirm, were there any changes to the protocol that the FDA asked for just broadly? Speaker 600:25:09And also based on this the Type C meeting, Can you move ahead with part 2 of the study or following part 1, is there any need to Meet with the FDA again. I know you guys have you can have multiple meetings with the FDA given your designation, Fast Track Speaker 700:25:37I can take it. Hi. So the first question whether there have been changes to the protocol We requested by the FDA, the answer is no. But as Andreas mentioned before, we are going to add this 1 cohort Alo and K cells alone, that's the first question. And the second question, there is no need for us to go back or consult with the FDA to So that means we can proceed from the beginning to the end as approved by the FDA. Speaker 600:26:12Got it. And also just another clarification, is this, Allo and KL2 cohort needed For accelerated approval submission? Speaker 700:26:27When we spoke to the FDA during IND Process and also during Type C, right, the contribution of single components is important to the agency. And therefore, the assumption is, yes, this is something which we need to get accelerated approval. Speaker 600:26:46Great. Thank you so much. Speaker 700:26:48You're welcome. Operator00:26:49Thank you. One moment for our next question please. Our next question comes from the line of Lee Wasek with Cantor Fitzgerald. Your line is now open. Speaker 800:27:01Hey, thanks for taking my questions. Maybe just a follow-up For the new NK cohort, can you just clarify, do these patients need to Progress before they can crossover, maybe just a little more color on the criteria for crossover. And then can you count these patients in the total and to support the efficacy as well? Speaker 200:27:31Wolfgang, you want to take that? Speaker 700:27:34Yes. I can take that question. Yes. These patients, right, when treated with LONK IL-two, if they are not responding, That means if they are not showing a partial response or a complete response, they will have the opportunity to cross over to the combination treatment. Now this brings me to your second question, whether these patients then could go crossover into the analysis cohort For the primary endpoint, and the answer is no, because there could be a bias. Speaker 700:28:10So what we are having, right, is that we say They came crossover to the combination treatment and will be treated, but not be part of this analysis for the primary endpoint. Speaker 800:28:23Okay, got it. And then you mentioned earlier you had the 1st site open enrolling patients. Just can you give us some sense in terms of how many sites do you need to fully enroll the run-in portion? Speaker 700:28:40Andreas, do you want to go ahead and answer the question? Speaker 300:28:46Yes. I mean for the run-in portion, as you know, there is somewhat of a staggered approach, especially for the first three patients per cohort. So our current assumption is that we probably need 5 to 6 good recruiting sites for the initial For cohorts and then we will bring more sites on board as the study progresses or continues. But we are in active process to add sites. But as we said, we are on track to provide the Initial safety and efficacy data are first half of twenty twenty four. Speaker 800:29:26Okay. Thank you. Operator00:29:29Thank you. One moment for our next question please. Our next question comes from the line of Diana Graybosch with Leerink Partners, your line is now open. Speaker 900:29:41Thanks. Two questions from me. One on the new AB-one hundred and one arm. I think you had known that it was a possibility that FDA would want an arm like this for contribution of components. But initially my understanding is, didn't include it in the design because KOL feedback that they were hesitant to enroll patients into such an arm Given the preclinical data suggesting NK Cells alone wouldn't have benefit, I wonder how have your conversations gone with KOLs and sites and What can you do to ensure enrollment into this arm and enrollment overall to this study now that this arm is a possibility? Speaker 900:30:22And then my second question is on AFM24. And there's been particularly in EGFR mutant lung cancer, but also across your indications, a lot of interesting data with antibody drug conjugates. And I wonder whether there's potential down the road after you show benefits that combine with chemotherapy and if you're considering that in the form of an ADC going forward? Thank you. Speaker 300:30:53Andreas, you can take both questions. So, yes, so the LONK IL-two arm, as you mentioned, It's an arm that we added also after discussion with some of our clinical advisory opinion leaders. Probably the only way to make such an arm, recruiting arm is what we implemented now that we give patients the options they do not have After cycle 1, they can immediately cross over to the combination treatment. So they will have the option to receive What we believe is a more active treatment. And again, as I said, we believe that the number of patients in this arm will be relatively small as we are Not expecting to see a very high response rate here. Speaker 300:31:45So this is, I think, a good compromise that most of our clinical sites believe It's acceptable to patients. If you would have an arm that has only alloNK cells without the option to crossover, I think you would have Quite significant challenges to recruit in such an arm. As for AFM24, yes, we have a number of indications, In the non small cell lung cancer field where we do see ADCs coming up and We believe that the mechanism of action of AFM24 could fit very well with ADCs. So Combination either with TKIs, for example, in the EGFR mutant field or with ADCs These both in the non small cell lung cancer EGFR wide app and EGFR mutant fields are definitely options that we would look at after we have completed our 102 study. Speaker 800:32:53Great. Thank you. Operator00:32:55Thank you. One moment for our next question please. Our next question comes from the line of Ynon Hu with Wells Fargo. Your line is now open. Speaker 1000:33:07Great. Thanks for the questions. Two questions on the AFM13 program. The first one is how is the infusions of the NK and AFM13 Handled on the day of infusion. I was wondering, since this is not a pretty complex product, Which component is infused first? Speaker 1000:33:35And what is the space of time between the 2 infusions? The second question is about how you select the 2 cohorts for Stage 2. Would that be based on 2 cohorts having to have the same NK component NK dose or having of these or these 2 cohorts having to have the same AFM13 dose Or it doesn't matter, just the 2 cohorts with the best performing ORR. Thank you. Speaker 200:34:11Andrea? Speaker 300:34:15Yes. So in terms of administration and how the trial country is designed, We start on the days where we give AFM13 our symptomatic and NK cells with the symptomatic infusion. Initial infusion duration is 4 hours for the 1st cycle, but with the option to reduce the duration of the infusion if No infusion related reactions. Then we have a 1 hour break and then we have the NK cell infusion, which usually It's a pretty short 15 to 30 minute infusion. This is based on the previous experience, especially with rituximab in B cell lymphomas were, I think, in all programs, rituximab was given first to allow some On distribution of rituximab throughout the body and then followed by the NK cells, which has quite well worked in the B cell field. Speaker 300:35:16So this is how the regimen would be handled. And the second question was around selection of the Appropriate cohort. Again, there is no pre specification. So we do not necessarily have to use the same cell dose or the same Asymptomatic dose in the 2 cohorts, we will do a good assessment or thorough assessment of the risk benefit profile, both looking at efficacy and safety. Based on that, we'll select the 2 most appropriate cohorts for the Part 2 of the study. Speaker 1000:35:52Great. Thank you. Operator00:35:56Thank you. One moment for our next question please. Our next question comes from the line of Brad Canino with Stifel. Your line is now open. Speaker 1100:36:07Hi. Thanks for the question. Speaker 1200:36:09I had a 2 parter. One of them was about your view on the durability when it comes to the Accelerate approval previously. So on top of that, I guess I want to ask, Do you expect the MD Anderson presentation, which I think will include the final follow-up for the 3 to 4 cycle patients To be a definitive demonstration of the durability of your potential commercial product or would you tell us to wait for the Luminosity-two zero three data to start rolling in? Thank you. Speaker 200:36:38Andrea? Speaker 300:36:42That's a very difficult question. I think what we will show at ASH is clearly an update of both EFS or PFS Survival and overall survival, I would not say this will be the final as we already indicated in the abstract. There are Still quite significant number of patients in follow-up, so there could be a further follow-up data with even longer duration of responses Or survival. Now how these data translate into the LUMINI study is a little bit more difficult to answer. We believe that The 104 study is a very good proof of concept study, which I think indicates the magnitude of clinical effect that you could expect Based on all our preclinical data, we have shown that the Allo NK cell is very active and the coadministration If it all trends to be even a little bit more potent than the pre complex thing, again, with a caveat that this is Preclinical data, but we believe that 104 is probably a very good indicator of what can be Speaker 700:37:59Thank you. Operator00:38:02Thank you. One moment for our next question please. Our next question comes from the line of Yulai Jen with Laidlaw and Company. Your line is now open. Speaker 1100:38:14Good morning and thanks for taking the question. You have introduced The concept or the phenomenon of double refractory patients. So my question is, Does the LUMIN-two zero three study only include patients with this Doesn't mention all this phenomena or you will have single refractory patients as well? Speaker 300:38:46No, I can take this. All patients that are recruited into Lumineis have to be double refractory. So The requirements is that they have at least failed 1 combination chemotherapy regimen, they have failed BV and they have failed PD-one. So if you will, it's more or less triple refractory, so chemotherapy refractory, PD-one refractory and BV refractory. So This is the patient population where we believe there's absolutely no medical alternative and these patients are in dire need for active treatment. Speaker 1100:39:20Okay. That's very helpful. And in terms of FMD Anderson studies with the Core blood cells. Most of the patients also being categorized into this category or There are some sort of single refractory patients. So I just wanted to get some sense of how to think about that data versus The future readout you have in first half of next year. Speaker 300:39:50Yes. So in the MD Anderson trial, The patients with Hodgkin lymphoma all fall into this category of double refractory. So all patients RBV and PD-one refractory. As you remember, we also had a very small group of Five patients of non Hodgkin lymphoma as PD-one is not approved for all non Hodgkin lymphomas. We have 2 patients in the non Hodgkin lymphoma cohort that have not been exposed to PD-one, but have been exposed to BV. Speaker 300:40:24But again, the core populations, the hot skin lymphoma population, all patients have been double refractory to BV and Speaker 1100:40:36Okay, great. That's very helpful and thanks and congrats on the progress. Operator00:40:43Thank you. One moment for our next question. Our next question comes from the line of Sean Lee with H. C. Wainwright. Operator00:40:58Your line is now open. Speaker 1300:41:01Good morning, guys, and thanks for taking my question. I was just wondering if you could provide a bit more color on What type of data can we expect from AFM24 at ASH? You mentioned you can expect the first three cohorts? Speaker 200:41:18Andrew? Speaker 300:41:20Sorry, I had a little bit of a disconnect. Can you repeat your question? Speaker 700:41:25Sure. I was just wondering if Speaker 1300:41:27you can provide a bit more color on the type of data that you can expect from ASH for AFM24 from the 1st 3 quarters, I think, as you mentioned? Speaker 300:41:39Yes. So AFM24 will not be at ASH, but will be a separate Disclosure of the data will happen in December. Now as we said, we have the 3 cohorts, which is EGFR, white titlonsmallcellungcancer, gastric cancer and then the basket cohort that was HCC pancreatic and biliary tract. And we have about 10 to 15, it varies a little bit from cohort to cohort responsive valuable patients where we will show Mainly response rates, I think it's too early to have a long term follow-up data as Many of these patients were recruited over the last 6 months, but we should have quite robust response data for these 3 cohorts. Speaker 500:42:25Got it. Thanks. Operator00:42:30Thank you. I am currently showing no further questions at this time. This concludes today's conference call. Thank you for your participation. You may now disconnect.Read moreRemove AdsPowered by