Affimed N.V.

Good day, everyone, and welcome to the AFMED second quarter 2022 financial results and corporate update conference call. My name is Vanessa, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. During the question and answer session, if you have a question, you can enter the queue by pressing zero, then one on your touch-tone phone. As a reminder, this conference is being recorded. I would now like to introduce your host for today's call, Mr. Alex Fudikidis, Head of Investor Relations at AFAMED. Sir, you may begin.

Thank you, Vanessa, and thank you all for joining us today for our 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 members of our management team, including Adi Hurst, our chief executive officer, Andreas Harstrick, our chief medical officer, Arne Chatelius, our chief scientific officer, Denise Mueller, 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 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 our filings with the SEC, and those identified under the section entitled forward-looking statements in the press release that we issued today and files with the SEC. With that, I'll turn the call over to Adi. Adi?

Thank you, Alex. Good day, everyone, and thanks for joining our second quarter 2022 financial results and operational progress update call. We have a clear vision and goal to be the leading innate cell in the Asian company and to stop cancer from derailing patients' lives. At AUCR this year, we presented groundbreaking data from the combination of AFM13 with NK cells in relapsed refractory Hodgkin lymphoma patients. Having achieved 100% objective response rate is particularly impressive given the fact that these patients had undergone a medium number of seven prior lines of therapy. and in most cases had exhausted all approved and experimental therapy. Since the data were presented, the study has continued to enroll well, underscoring the high need for novel options for these patients. Now, we believe our inertal engager technology, through its bispecific and tetravalent structure, with a very high affinity binding to CG16A on natural chelophiles and macrophages, without the competition from circulating immunoglobulins, is at the core of these impressive results. The unique attributes of our technology have enabled us to demonstrate meaningful anti-tumor activity for our inner cell engagement molecules as monotherapy, and in combinations, including a strong synergy with PD-L1 checkpoint inhibitors, and most recently in combination with natrikylacil presence. We're indeed very excited about the many upcoming data readouts across the three-pronged strategy approach. And today, I will summarize our expectation for the remainder of this year. Moving to slide four. For AFM13, we show that we have two ongoing studies. For the registration-directed study for AFM13 as monotherapy in relapsed and refractory peripheral T-cell lymphoma, also known as redirected. we remain on track to deliver top-line data in the fourth quarter of this year. The study enrolled more than 100 relapsing refractory TTCL patients, and the focus of the initial data release will be on the overall response rate as assessed by a blinded independent review committee and a preliminary assessment of the duration of response. Just as a reminder, PTCL is a disease with a significant unmet need. There are nearly 1,500 patients just in the US each year representing with relapsed or refractory PTCL. Treatment options are very limited, and the prognosis for these patients remains very poor. The second ATOM13 study is the Phase I-II study in collaboration with the MD Anderson and Cancer Institute, evaluating co-blood-derived natural killer cells pre-complex with AFM13, followed by single-agent AFM13 treatment, again, in patients with relapsed refractory CD30-positive lymphoma. Data presented at this year's ASER conference by Dr. Iago Nieto, the lead investigator of the trial at MD Anderson, demonstrated that after a second cycle of treatment, the complete response rate at the recommended phase two dose increased from 38%, as reported in December 2021, to 62%. This was achieved in 13 patients. The overall response rate remained at 100%. And the treatment was determined safe and very well tolerated by patients which is now allowing MD Anderson to continue to treat patients with up to four cycles. Durability of response data presented for patients treated at the recommended phase two dose was also promising. Of the eight patients who achieved a complete response, seven remained in complete response at a median follow-up of six and a half months, including two patients who had remained in response after 10 months, and two who received a consolidation autologous stem cell transplant. Indeed, enrollment in the study is progressing very well. As of July 31st, 30 patients have now been treated, including 24 at the recommended phase two dose of one times 10 to the eighth cold blood derived NK cells per kilogram, which represents an additional 11 patients treated at that dose since our latest data update at ACR. Important to note here is that based on the amended protocol, some patients have now received up to four cycles of treatment and new patients are being enrolled at the recommended phase two dose. We're expecting that Dr. Nieto will report updated data from the study at a major scientific conference in the fourth quarter of this year. We're also progressing very well with our encased cell strategy to ensure access to an off-the-shelf cryopreserved encased cell for further development with our inert and engaging molecules. And we expect to announce the development path for AFM13 with a specific encased cell again in the second half of 2022. Now let me jump to AFM24. As shown on slide five, We continue to enroll patients in all three ongoing studies, including the expansion cohort for our monotherapy study and the dose escalation for the combination studies, one with atezolizumab and the other one with the SNK01 autologous NK cell product from NK-CHEM. As we discussed on our last call, we completed the dose escalation part of the monotherapy study and determined and confirmed the 480 milligram weekly dose as our recommended phase two dose. We're continuing to enroll patients in the expansion phase of the monotherapy at the recommended phase two dose. The expansion cohort include patients with renal cell carcinoma, non-small cell lung cancer, and colorectal cancer. Updates from the monotherapy study including clinical data from the dose escalation phase will be presented at ASMO and a further update with correlative science data is expected to be presented at the scientific conference later this year. We are also continuing to enroll patients in the dose escalation phase of the two combination studies. The primary purpose of the dose escalation phase of these studies is to establish the safety of the two combinations and identify the recommended phase two dose for the dose expansion phase. In AFM24-102, this is the combination of AFM24 with atezolizumab, we are treating patients with non-small cell lung cancer, gastric cancer, and a basket comprising pancreatic hepatocellular biliary tract cancer. In this study, we have completed the first dose cohort and are enrolling into the second cohort at 480 mg, which is the recommended phase 2 dose of AFM24. A presentation of such data from this study is expected at the scientific conference in the fourth quarter of this year. Now, a second combination study called AFM24-103 is investigating the combination of AFM24 with SNK01, which is an autologous, in case I say that, company called NKGEN Biotech. This is investigated in patients with non-small cell lung cancer, squamous cell carcinoma of the head and neck, and colorectal cancer. In this study, we are nearing completion of cohort one, which is treating patients at 160 milligram of AFEM24 and a fixed dose of SNK01, and an update is planned based in progress. Moving to AFM28, our third wholly owned inert and engager targeting CD123 in patients with AML. As planned, we submitted an IND to the FDA in June. Following discussion with the FDA regarding the IND and specifically the design of the dose escalation, we have taken a strategic decision to focus early clinical development of AFM28 outside the US. We believe this decision will enable us to conduct the dose escalation and identify the recommended phase two dose faster. And we now expect to initiate the clinical study in the first half of 2023. We intend to re-engage with FDA after data from the dose escalation has been generated. As we've mentioned, AML is one of the worst blood cancers with poor patient prognosis. especially in the relapsed or refractory setting, with no standard of care salvage regime currently available. Given the aggressive nature of the disease and desperate need for viable treatment options, it is a high priority for AFIMET to be able to offer this treatment option for such AML patients as quickly as possible. We believe this strategy will help to achieve this goal. Finally, we're also advancing our work with existing partners In the case of Genentech, we've made good progress in various preclinical programs and handed over several programs to them for further preclinical development. In our partnership with Roivent, AFM32, or called by Roivent AFVT 2101-33, is currently being investigated in R&D enabling studies. We are eligible for additional proceeds from these key collaborations in the near term, including curriculum and the milestones, as well as milestones based on early regulatory achievement. We're continuing to build on our core strengths and competencies to deliver on the goals that we have set for ourselves for the next few months, and we are building the foundation to drive value for shareholders and patients alike for 2022 and beyond. With that, I'm turning over the call to Angus. to give you an update on the financial status. Angus?