Affimed N.V.

Good day and thank you for standing by. Welcome to the AFAMED 2021 financial results and corporate update conference call. At this time, all participant lines are in listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star then one on your telephone keypad. Please be advised today's conference may be recorded. If you require operator assistance during the call, please press star then zero. I'd now like to hand the conference over to Alex Fudikidis, Head of Investor Relations. Please go ahead.

Thank you, Liz, and thank you all for joining us for our call today. 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 following members of our management team. Adi Herz, our Chief Executive Officer, Andreas Harstrick, our Chief Medical Officer, Arne Sertelius, 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 the 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 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 Violence with the SEC, and those identified under the section entitled Forward-Looking Statements 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 thank you for joining us for our full year 2021 financial results and operational progress update call. I would like to start the call today by taking a moment to thank all of our employees, collaborators, and patients for their dedication, passion, and commitment to our work and the strong execution in 2021, which again was a very challenging year given the ongoing pandemic. We could have not accomplished all of that without everyone's dedication, passion, and the belief in our work. AffiMed employs an ever-growing multinational team of very talented individuals from around the world, in particular from all places in Europe. Indeed, the events that have recently unfolded in the Ukraine are of particular concern to me, all our colleagues at AFIMED. I must say I'm very proud of the way that our colleagues have pulled together in support of Ukraine in whatever ways we can. We have a few employees in our organization then you realize how much you have to stand behind the Ukraine. And we will continue to do that, whatever we can do in order to support its people, including our indeed Ukrainian colleagues and those who have loved ones and family in that country. With that, I want to turn over to give you an update on the progress that's not just been given by me, but all my colleagues will contribute. 2021 was a year of many transformative achievements for us in the company a year indeed in which we laid the groundwork for what we hope to accomplish in 2022 and beyond and for creating a number of important catalysts for our company we've been making exceptional progress in all our programs and in particular with work that we're conducting when we combine our inner cell engagers with ventricular cells. By the end of 2022, we expect to have three inner cell engagers in the clinic, which we believe will be the basis for continuous data flow over the next several quarters. As shown on slide three of our presentation, development efforts for each of our inner cell engagers It's focused on patients where we see significant unmet medical needs that may allow for fast-to-market development approaches. We have built a very strong rationale for the development of all our inner-cell engagement molecules as monotherapy and in combinations. We are very pleased to have clinical proof-of-concept data for ASM13 which provides key validation for our approach to developing our molecules as monotherapy in combination with natural killer cells and checkpoint inhibitors. This proof of concept supports the three-pronged approach that we are applying to development strategy for all our other inert cell engagement molecules. We believe that by giving patients novel treatment options, we have an opportunity to potentially develop blockbuster therapy. As an example, AFM13 now is shown on slide four. Targeting several CD30 positive lymphoma will be able to address several patient population, starting initially with relapsed and refractory peripheral T cell lymphoma. The development approach in T-cell lymphoma will be able to impact the life of approximately 1,500 patients just in the US. Earlier this year, we announced the completion of enrollment in our redirect study, which focuses on peripheral T-cell lymphoma. And we are on track to report top line data from this study in the second half of 2022. This indication, however, represents only a small fraction of the entire CD30 opportunity which includes patients with Hodgkin, T-cell, and B-cell lymphoma. And according to our analysis, these indications have an annual incidence of approximately 20,000 patients in the U.S. alone. Now in December of last year, we presented compelling data of AFM13 in combination with netracular cells. If you may recall, a unique feature of our inner cell engager is the very high affinity and the specificity to CD16A, allowing the pre-complexing of neutral kilotons with AFM13, which now forms a stable CAR-like NK complex. In addition, we have furthered dosing with AFM13 monotherapy, a unique option for our inner cell engager, and differentiated from what you can do with CAR and K cells. We believe that AFM13 infusions are retargeting donor-derived and patient-owned NK cells and potentially macrophages, thereby contributing to the efficacy. In that trial, we reported an unprecedented 100% objective response rate after just a single cycle of treatment for 13 patients treated at the recommended phase 2 dose. Now, based on this impressive data, We believe that we can address the unmet need in additional indications that I mentioned earlier through the same development approach of combining AFM13 with natural kilotons. Now, our initial target population is relapsed refractory peripheral T-cell lymphoma and Hodgkin lymphoma, which now comprises 3,500 patients just in the US. But we have the plan to expand the label to include frontline peripheral T-cell lymphoma and relapsed refractory B-cell lymphoma in the second wave, which now creates an opportunity to address about 7,500 patients in total in the US. Importantly, our initial market research also indicates that we may have an opportunity to price the AFM13 and K-cell combination therapy at a premium to CAR-T therapies, as the safety of our combination has a profile that eliminates the ancillary costs associated with the management of safety events with CAR T approaches. In addition, our ambition for AFEM 13 is to make it globally available to patients who need these treatments, either as monotherapy or in combination with natural killer cells. The combination of all of these factors now gives us confidence in a very significant market opportunity for AFEM 13. Now let me switch to AFIM24, our EGFR expressing targeting inertial engages, where we have embarked on a broad development strategy. The opportunity for AFIM, the market opportunity for AFIM24 is shown on slide five of that presentation. End of last year, we achieved a key milestone for AFIM24 through the identification of the recommended phase two dose 480 milligram flat dose weekly. And here, too, we are implementing our three-pronged development strategy, which includes the initiation of three studies investigating various EGFR-expressing solid tumor indications, now in a total of nine cores. Remember what I said earlier, that we already have clinical proof of concept for AFM13 as monotherapy and in all these combinations. Now let's have a look at the market opportunity. Non-small cell lung cancer is represented in all three studies. Colorectal cancer is represented in two out of the three studies. And we are further targeting other key EGFR-expressing tumor types, such as renal cell carcinoma, head and neck, and gastric cancer. Now, non-small-cell lung cancer and colorectal cancer are by far the largest EGFR-expressing indications, with a combined relapsed refractory patient population in the US over 130,000 patients. So this number clearly tells you that these are in high need of novel therapies that are differentiated. Here again, there is a significant opportunity as these patients need better response rates drugs with better response rate and the duration of response over existing therapies that as we have already outlined have clear limitations not just on the efficacy side but also on the safety side let me switch shortly to over over to afm 28 yet a critical drug but we will spend some time explaining you the background of afm 28 and why this becomes very important for us in it. So AFM28, our CD123 tumor-expressing targeting innate cell engager, we're initially planning to target patients with relapsed and refractory acute myeloid leukemia, short AML. AML is the most common form of leukemia with over 40,000 patients diagnosed in the seven major markets every year. and over 11,000 in the relapsed refractory setting in the U.S. alone. So AFM28 is currently prepared for clinical evaluation, and as I will explain later, we believe that AFM28 is ideally suited to address the needs of AML patients, and we're planning to submit an ID application during the second quarter of this year, following a pre-IND meeting with FDA. We expect to initiate the first inhuman study in the second half of 2022. We have been and are continuing to work with MD Anderson, Arteva, NK Chen, and other third parties to ensure access to an off-the-shelf cryopreserved metric killer cell for further development with our inner cell engagement therapy. We expect to provide additional updates on NCASEL development now during the second half of this year. Our progress, data, and the opportunity represented by our Inertial Engager program has also captured the attention of potential future partners, in particular our data that we published in December. There is a very good momentum around our ability to clinically execute our programs supported by strong data, and there is interest from the pharmaceutical industry to further explore how our ROP platform and inert cell engager molecules can add value to these parties' existing pipeline and oncology franchises. We're also continuing to advance our work with our existing partners. A key feature that has enabled these partnerships is the differentiated performance of our inert cell engager when compared to standard IgE-based formers. with a particular advantage in addressing tumor cells with low target expression and also with the unique features that we have shown for the combination of opportunities. In the case of Genentech, we have made progress in various pre-CMD programs and have begun to hand over molecules to Genentech for their further development. Our partnership with Roivent on AFM32 is strong and AFM32 has moved into IND-enabling studies. Detailed updates on these programs are or is at the discretion of our partners. We remain eligible for additional proceeds from these key collaborations in the near term, including being eligible for preclinical milestones, as well as milestones based on early regulatory achievement and also clinical progression. Finally, we're also strengthening our organization and advanced our ideas and are recruiting highly talented scientists and industry experts to help us execute our mission. Now with this, I'll turn over the call to Andreas to give you more color on the progress of our programs. Andreas?