Affimed N.V.

Ladies and gentlemen, thank you for standing by. Welcome to today's full year and fourth quarter earnings and business update conference call by AppMed NV. As a reminder, all participants are in listen-only mode. A question and answer session will follow the form of presentation. Please note this conference call is being recorded. I would now like to hand the call over to your host for today, Alex Budokidis, Director of Investor Relations at AppMed. Please go ahead.

Thank you, Livia, and thank you all for joining us today for our full year 2022 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 the members of our management team, including Adi Hirsch, our chief executive officer, Andreas Harstrick, our chief medical officer, Arne Sotelius, our chief scientific officer, Wolfgang Fischer, our Chief Operating Officer, Denise Miller, our Chief Business Officer, and Angus Smith, our Chief Financial Officer. The team will be available for the Q&A session 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 these forward-looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statement, even if new information becomes available in the future. These forward-looking statements are 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. With that, I'll turn the call over to Ari. Ari?

Thank you, Alex. Good day, everyone, and thank you for joining us for our 2022 year-end results and operational update call. I'd like to begin by reviewing the key highlights of 2022, during which we made exciting progress across all our pipelines. Let's jump to slide four of the presentation. And importantly, in 2022, we generated highly compelling results with AFM13 in combination with natural killer cells. We did sign a partnership with Arteva now that gives us access to a commercially viable co-blood-derived natural killer cell And we advanced our other clinical programs, AFM24, and now most recently AFM28. From the data we reported, there are a number of key findings about our inertial engagers and their specific mode of action, which we believe are differentiating features versus other NK cell engager approaches, as well as engineered NK cells, including CAR NK. The unique mode of action of our innate cell engages generated from the ROC platform has always included the ability to engage different innate immune effector cells, such as NK cells and macrophages. And this effective engagement of the innate immune system has proven now to trigger an adaptive immune response, leading to a full immune response during T cells. We believe that this feature is unique to our inert cell engagement. As we show on slide five, this differentiating feature of our inert cell engagement molecule was demonstrated through our work in our AFM24 monotherapy study. Until the last year, we presented data on AFM24 monotherapy, showing this read-through to the adaptive immune system, the activation and migration of cytotoxic T cells into the tumor. We can further strengthen the full immune response through combinations with PD-1 or PD-L1 checkpoint inhibitors, which allow now these T-cells to attack the tumors in the tumor cells. The well-established safety profile of our inertial engagement molecule enables these combinations to deliver additional clinically meaningful benefits to cancer patients that indeed remain undeserved. The potential success of this combination approach was most recently observed in our AFM24 combination study with atezolizumab, where a gastric pain patient who had disfiguring skin lesions and failed to respond to any previous treatment, including a checkpoint inhibitor, had her skin lesions nearly fully eliminated with a substantial reduction in her primary gut GI tumor. Now let's jump to AFM13. With the completion of our Phase IIb redirect study, we demonstrated that AFM13 has single-agent efficacy and is safe and well-tolerable for patients. Redirect indeed showed good efficacy in a very difficult-to-treat patient population that currently only has very limited treatment options, in particular once relapsed refractory. As of the end of 2022, We have treated overall approximately 200 patients across all our AFM13 programs and saw a very consistent and manageable safety profile. Now, even though we saw efficacy for monotherapy, we made the decision to pursue the treatment based on the combination therapy of AFM13 with natural chelosomes. The much stronger efficacy seen with this type of treatment And the ability to address a much larger patient population led us to the decision to move forward with this combination. Our commercial analysis, as well as insights from our work on AFM13 with encasals, strongly now suggests that we can deliver more benefit to CD30-positive lymphoma patients with this approach, including Hodgkin lymphoma and T-cell lymphoma patients. Treating patients with a combination therapy is expected to deliver better and more durable efficacy. It is the right thing to do for patients, and it's also the most efficient use of company resources. Now, let me jump to slide six, which shows here our priorities for 2023. Our number one this year is the execution of the AFM13 AB101 clinical development plan. We call the program AFM13-203. We're looking forward to submitting the R&D and getting this important study up and running. We know from the data and our work with our partners at MD Anderson that the combination of AFM13 with NK cells can deliver meaningful therapy to patients with significant medical needs. Let me just give you an example. A patient that always comes to my mind is a young 54-year-old woman who was being sent to hospice after five lines of therapy that included combination chemo, brentuximab, bedotin, and an anti-PD-1 antibody. Now, this patient had a complete response with the AFM13 and KSO combination. This is the type of patient outcome is why we come to work every. We believe our TIVA cells as the key features that will allow for similar clinical results, as those resolved with the MD Anderson cell, and, very importantly, meet critical commercial requirements. Today, we can share with you that the data Akiva has seen so far from the AB101 rituximab combination study looks quite encouraging, particularly given that several patients are relapsed or refractory to prior Cartiva. expect to provide an update on this clinical trial later in the year. Moving on to April 24, we're generating data that will inform critical decisions on the future development path. As Andreas will discuss, we expect to have data from all three studies this year. This will allow us to analyze where we are seeing the most promising activity, thereby enabling our decision on where to focus further investment. Our third asset in clinical development is AFM28. Key activities for the monotherapy trial in Europe are underway with multiple CAs in place for approved sites and enrollment initiated at our lead site in Spain. Our goal in the phase one study is to confirm the safety profile and understand potential cytotoxic activity. Once we begin to understand the monotherapy profile, we intend to swiftly advance into a combination study with an NK zone, as we believe the science supports this approach as a compelling differentiated therapy. Now, with that, let me turn the call over to Andreas, who will provide additional insight on our clinical pipeline. Andreas?