Affimed N.V.

Good day, everyone, and welcome to AFL-MED's fourth quarter and four-year 2023 earnings and corporate update call. At this time, all participants are in a listen-only mode. As a reminder, today's conference is being recorded. After the speaker's presentation, there will be a question and answer session. To ask the question during the session, you will 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 start 11 again. I would now like to hand the conference over to Alexander Futakidis, Head of Investor Relations at Apple. Please go ahead, sir.

Alexander Futakidis, Head of Investor Relations at Apple Thank you, Tawanda, and thank you all for joining us today for our quarterly update call. Before we begin, I'd like to remind everyone that we issued the relevant press release earlier today, which can be found on the investor relations section of our website. On the call today, we have our management team, including Andreas Harstrick, our Chief Medical Officer and Interim Acting Chief Executive Officer, Wolfgang Fischer, our Chief Operating Officer, Denise Mueller, our Chief Business Officer, and also on the call today, we have Michael Wolff, our VP of Finance, and Harry Welton, our Consulting Chief Financial Officer, to review the financials with us today. 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 reasons why actual results could differ materially from those anticipated in the forward-looking statement, even if new information becomes available in the future. These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the statements due to various factors, including but not limited to those identified under the section entitled Risk Factors in our Filings with the SEC. and those identified under the section entitled forward-looking statements in the press release that we issued today and filed with the SEC. With that, I'll turn the call over to Andreas. Andreas?

Thank you, Alex, and good day, everyone, and thank you for joining us today for our Q4 quarterly and full year 2023 earnings call. In 2023, despite challenges in the broader biotech industry, AFIMED not only achieved meaningful milestones that underscore our resilience and commitment to advancing our innovative therapies, but more importantly, we laid the groundwork for significant advances across our three clinical assets, AFM24, the Symptomic, and AFM28 in 2024 and beyond. For AFM24, we saw clinical activity in combination with etesolizumab across all tested cohorts with the most notable efficacy in non-small cell lung cancer. This data validated the concept of a crosstalk between the adaptive and the innate immune system as suggested by our translational research data from the AFM24 monotherapy study. and led to the refinement and focus of our clinical development plan. Going forward, we will have a heavy focus on non-small cell lung cancer with the ambition to address unmet medical need in patients for whom standard of care including platinum-based chemotherapy and PD-1 targeting therapy has failed. For a symptomatic We reached a significant milestone with the initiation of the LUMINIZE-203 study. Notably, the study design, based on FDA feedback and guidelines, coupled with the FAST-TAC designation, reflect our commitment to expeditiously bring the therapy to patients in need. Furthermore, we made progress with AFM28 dose escalation study. With recruitment underway in the sixth and final dose cohort, we are making steady strides towards advancing the potential of AFM28 as a therapeutic option for patients with refractory AML. Looking ahead, our primary objective is to drive the momentum of our clinical programs and achieve critical data milestones. To this end, we conducted a comprehensive strategic review of our operations, financial outlook, and market conditions. In response, we implemented a significant restructuring initiative in January to focus our attention and resources on the advancement of the clinical programs, which we believe have the potential to significantly increase in value as they progress. We reduced our workforce by approximately 50% and focused the organization on clinical development, clinical and regulatory operations, and translational research. Importantly, we also kept key competences in relation to NK cell biology and ICE manufacturing in-house. Let me give you a quick update on where we stand with our different programs. I will start with AFM24, as we are very excited about the progress that we have made. As we show in slide five, we announced earlier this year that we refined our focus to target patients with EGFR wild-type and EGFR mutant non-small cell lung cancer. We added the EGFR mutant cohort to our combination trial with Atezolizumab after seeing promising results with AFM24 monotherapy in this indication. We believe that the combination of AFM24 with atezolizumab has the potential to demonstrate a meaningful clinical benefit with a favorable safety profile in treatment refractory non-small cell lung cancer patients. As shown on slide six in January's update report, we highlighted the progress in the EGFR wild-type non-small cell lung cancer cohort where we observed a disease control rate of 73%, including 47% of patients with tumor shrinkage and four objective responses in 15 patients. The responses included one confirmed complete response and three confirmed partial responses. Of special importance is the fact that three of the four responding patients had never achieved an objective response to previous PD-1 targeting therapy, and that the only patient with a previous response to PD-1 responded to a combination of PD-1 and doublet chemotherapy. Therefore, even in this patient, making the contribution of PD-1 unclear. Even more remarkable is the fact that all four responding patients had progressive disease while still on previous PD-1 treatment regimens. We are now following these patients to generate mature PFS data. The median follow-up for this initial cohort is now six months, and we will be able to report final PFS data around Q2 2024. Based on this promising initial data from the EGFR-white type non-small cell lung cancer cohort, We have extended recruitment and will include up to 40 patients in this cohort. We also made progress in advancing the cohort for EGFR mutant non-small cell lung cancer patient. The target is to enroll 25 patients in this cohort and enrollment is well underway. We are very excited by the promising prospects of the AFM24 trials, recognizing the profound impact a successful outcome could have in addressing a critical unmet need. As we show on slide seven, the standard of care for patients with platinum and PD-1 refractory disease is usually chemotherapy, resulting in an average progression-free survival time of around 4.5 months. Importantly, single agent PD-1 therapy, even in PD-1 naive patients that are platinum resistant, has shown a progression-free survival of only around 2.5 months. Moving now to our hematological assets, starting with Symptomic and our LUMINISE-203 study, as shown on slide 9. Following FDA clearance to proceed with a Phase II study, which we discussed on our last call, recruitment in this study is proceeding. Initial recruitment in cohorts one and two was slightly slower than anticipated. This was caused solely by the mandatory staggering of enrollment for the first three patients per cohort and the drop out of some patients during the screening period. As we are now beyond the period of staggered enrollment for cohorts one and two, we see steady progress and expect to initiate recruitments into Quarts 3 and 4 in the next couple of weeks. On the positive side, we see that patient availability per site appears to be higher than initially expected, reflecting the commitment of our investigators and the dire need of patients for inactive treatments. On the same slide, we show that Luminize 203 includes an exploratory arm for relapsed refractory peripheral T-cell lymphoma patients. PTCL represents a high unmet medical need with more than half of the patients progressing to second-line treatment where standard of care has very limited activity. Our confidence in the LUMINIZE-203 study is further enhanced by the presentation of the final results of AFM-13104 study the investigator sponsored clinical trial of cord blood-derived NK cells in combination with the symptomatic MD Anderson. Final results, as shown on slide 11, were presented at the American Society of Hematology annual meeting in December last year. The final data demonstrated a meaningful duration of responses, including about 30% of the complete responses ongoing for more than a year, and first patients approaching now two years of relapse-free survival. I believe that this data is outstanding, especially if we consider that none of these patients had responded to the therapy that was given prior to the study. So essentially in a patient population with a 0% response rate with any available standard of care. For AFM28, This brings me to the update of our third clinical program. Our CD123 targeting innate cell engager designed for patients with acute myeloid leukemia. As we show on slide 14, we are pleased to report continued progress in this program as we recently completed cohort five at 250 milligrams once weekly without encountering dose-limiting toxicity. Patient recruitment for cohort six is now open, which will be the final cohort of the phase one part of this program. Clinical, safety, and pharmacodynamic data of the study will be reported as guided in Q2, as well as an update on our strategy on how to advance the AFM28 program. Now let me pass the call over to Michael to highlight our financial operations results. Michael, please.