Affimed N.V.

Good day, and thank you for standing by. Welcome to AFIMED NV Third Quarter 2023 Earnings and Business 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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Alex Futakidis, head of investor relations. Please begin, sir.

Thank you, Norma, and thank you all for joining us today for our third quarter 2023 update call. Before we begin, I'd like to remind everyone that he issued the relevant press release earlier today, which can be found on the investor relations section of our website. The presentation is also on the website. On the call today, we have the members of our management team, including Adi Huss, our Chief Executive Officer, Andreas Harstreich, our Chief Medical Officer, Arne Stupelius, our Chief Scientific Officer, Wolfgang Fischer, our Chief Operating Officer, and Angus Smith, our Chief Financial Officer. The team will be available for 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 statements. even if new information becomes available in the future. These forward-looking statements are subject to risks and uncertainties and actually 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 statement and the press release that we issued today and filed with the SEC. With that, I'll turn the call over to Adi. Adi?

Thank you, Alex. Good day, everyone. And thanks a lot for joining us today, also from my side. We have entered a very important and exciting phase for us in it. 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 three Kennedy programs and are now in a period where we plan to report data frequently over the next weeks and months. Moving to slide five, we recently announced that the new name for ACE-M13 will be Asymptomic. Asymptomic is developed in combination with Arteva's Allo-NK product in the LUMINIZE-203 study. We're now actively recruiting Hodgkin lymphoma patients in the LUMINIZE-203 and preparing to report efficacy and safety data from the study in the first half of . As a reminder, during this phase of the study, we will be treating 24 patients with Hodgkin lymphoma in four cores. and all these cores will use active doses of asymptomic and allo-NK. In addition, our interactions with the FDA have been very productive. In September, we announced that we received fast-track designation, 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 LUMINOIDS-203 study design, based on FDA feedback and guidelines, puts us in a very good position to pursue accelerated approval. The LUMINOIDS-203 study builds on the unprecedented results observed in AFM13-104. The investigator-sponsored clinical trial we have been running in collaboration with Andy Anders. Updated data from that study will be presented by Dr. Iago Nieto, the lead investigator at the ASH annual meeting 2023 on December 11th. AFIMIT 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 dates. 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. This 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 inertal engager, asymptomic in combination with PD-1, is able to double the complete response rate of PD-1 alone in relapsed refractory hot conformer patients. During the third quarter, we also initiated enrollment in the North Muslim lung cancer EGFR mutant cohort and have begun treating patients. Again, as a reminder, EFIM24 is a single agent showed partial responses and durable stable diseases in this indication. Data from this expansion cohort is expected in the first half of 2024. And last, we continued to make good progress in our ASM28 monotherapy dose escalation. During the third quarter, we completed treatment of patients in the third-dose cohort without any limiting dose-limiting facilities and completed enrollment of patients in the fourth-dose cohort, now administering a flat-dose 200-milligram weekly. On slide six and seven, we provide important background on the treatment of the indications we're targeting with Luminize 203. In Hodgkin lymphoma, BV and PD-1 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, their BV and PD-1 double refractory population. Now let me quickly talk about which therapies exist in general for relapsed refractory Hodgkin lymphoma. For this patient population, cytotoxic agents such as platinum chemo, impendimustin, or even targeted agents such as linoleumide or mTOR inhibitors are listed in the NCCN guidelines. But it's important to note that these therapies were studied in relapsed refractory heart patients before the introduction of PV and checkpoint inhibitors. And limited information is available on their efficacy in the double refractory population. But even still, they are characterized by low ZR rate and poor peers. We believe this is where a symptomatic plus in case of therapy has the potential to transform the treatment landscape for double refractory patients. The response rates reported from AFM 13-104 are outstanding. And in particular, the ZR rate of 70 plus percent is higher than the CR rate of other treatments, even in less heavily pre-treated patients. And as next month, we'll provide a definite view on the duration of response and event-free survival for the therapy for HL patients treated at the recommended phase. Luminize 203 further includes relapsed refractory TTCL patients. TTCL 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 recruitment. Based on our market results, we believe the market opportunity for asymptomic plus-in-case cells in double-refractory Hodgkin lymphoma alone is in excess of 1 billion. And with the inclusion of second-line relapsed refractory TTCL, This would increase to over 3 billion combined. Finally, during the quarter, we saw a significant reduction in our operating cash burn as we come to the first two quarters of the year, a result of the actions we implemented during the first half of the year to focus our investments on our three clinical programs. With that, I'll turn the call over to Andreas, who will provide additional input on the progress we're making in our pipeline. Andrea?