Affimed N.V.

Good day, everyone, and welcome to AFIMED's first quarter 2023 earnings and corporate update call. At this time, all participants are in a listen-only mode. After the presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 1 on your telephone. You'll then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. As a reminder, today's conference is being recorded. I would now like to introduce your host for today's call, Alex Futakidis, Head of Investor Relations at Appamed. Please go ahead.

Thank you, Liz, and thank you all for joining us today for our first quarter 2023 update call. Before we begin, I'd like to remind everyone that we issued two relevant press releases earlier today, which can be found on the Investor Relations section of our website. On the call today, we have the members of our management team, including Adi Hirsch, our Chief Executive Officer, Andreas Harstreich, our Chief Medical Officer, Arne Schotelius, our Chief Scientific Officer, Wolfgang Fischer, our Chief Operating Officer, Denise Mueller, our Chief Business Officer, and Angus Smith, our Chief Financial Officer. The team will be available for Q&A after the prepared remarks. Before we start, I'd like to remind you that today's presentation contains projections and forward-looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this call. Except as required by law, we assume no obligation to update those 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 of 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'd like to turn the call over to Adi. Adi?

Thank you, Alex, and good morning, everybody. Thanks for joining our call today. I'll start with reviewing key highlights. And as Alex has already mentioned, I'm very pleased to report that we continue to make progress on our key priorities across the pipeline. As you can see now on slide five, First, we are extremely excited to announce the FDA clearance of our investigational new drug application for the combination of AFM13 with AB101. And we will call this study LUMINOIS-203. Indeed, this is a significant achievement for our company as it enables us to move forward with a Phase II study of this promising therapy. I'd like to thank all colleagues at AFIMED and Artiva who worked diligently in the past few months to make this possible. This treatment now will build on the findings that we have generated in the AFM13-104 study of AFM13 in combination with coblast-derived natural killer cells. Data which was presented by Dr. Iago Nieto from MD Anderson Cancer Center at the ASH conference back in 2022. Across our organization, we're committed to advancing the development of this therapy as fast as we can. The efficient and quick execution of this trial, assessing the combination therapy of AFIM13 and AV101 is a key focus for our company. Wolfgang Fischauer, Chief Operating Officer, will go into the details of the study design and timing late in the call. Andreas Hartstrick, our chief medical officer, will update you on the rest of our clinical programs. Second, we have continued to advance AFM24 clinical studies towards data milestones. AFM24 is our novel inner-cell engager targeting EGFR, and we believe it has the potential to be a transformative therapy for many patients with EGFR-expressing solid tumors. We now plan to present interim data from the monotherapy expansion cohort at the upcoming ASCO meeting on June 3. Specifically, we will be presenting data from the non-small cell lung cancer cohort, which has been accepted for poster presentation, and data from the colorectal cancer cohort, which has been accepted for online publication. The data will include about 15 patients from each court. The full text of the abstracts will be published later this week and will only include data as of the December 2022 cutoff date. The data in the NSCLC poster will include data from a later close date. We plan to host a call with the financial community to review the monotherapy data in more detail, as well as provide a strategic update on the AFM24 program. The virtual event will be held on Saturday, June 3. Details of the call will be included in our abstract release on Thursday. Finally, our phase one study of AFM28 monotherapy is proceeding quite rapidly. We're pleased to announce that the first dose cohort has already been cleared, and the study is now actively recruiting patients in the second dose cohort, which means all our pipeline programs have significant potential to address unmet medical needs and improve outcomes for a variety of hematological and solid tumor indications. With this, we are quite uniquely positioned to drive shareholder value in the near term. Before now I hand over the call to Wolfgang, I'd like to mention that considering the current market conditions, AffiMed has had to make a difficult decision to control our operating expenses by reorganizing our company to focus our efforts primarily on our Kennedy programs. As a result of the reorganization, we have reduced our full-time equivalent headcount by approximately 25%. We took extra care to ensure that this reorganization will not impact the development of our three clinical programs, and we believe we are well positioned to meet key data milestones for all three programs within the next three to 15 months. This now includes data from AFM13 in combination with AB101, data from all three AFM24 clinical studies, and data from AFM28 mono in AML as we continue to make progress with the dose escalation. And with that, let me turn over the call to Wolfgang, who will provide additional insights on the progress we're making in our pipeline.