Affimed N.V.

We're standing by and welcome to the AFAMED third quarter 2021 financial results and corporate update conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 on your telephone. As a reminder, today's program is recorded. I would now like to introduce your host for today's program, Alex Vadupiev, head of investor relations. Please go ahead, sir.

Thank you, Jonathan, and thank you all for joining us today for our third quarter 2021 results and operational update call. Before we begin, I'd like to remind everyone that we issued the relevant press release earlier today and that it can be found on the investor relations section of our website. On the call today, we have the following members of our management team. Dr. Adi Hirsch, our Chief Executive Officer, Andreas Harstrick, our Chief Medical Officer, Arne Chatelius, our Chief Scientific Officer, Wolfgang Fischer, our Chief Operating Officer, Ms. Denise Miller, our Chief Business Officer, and Angus Smith, our Chief Financial Officer. The whole team will be available for the Q&A session. Before we start, I will quickly go through the safe harbor statement. Today's discussion 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 in Files with the SEC. With that, I'll turn the call over to Ari. Ari?

Yeah, thank you, Alex, and good morning, everyone. Thanks indeed for joining our third quarter update call, and I'm very pleased with the continued progress towards our goal of bringing new and innovative life-saving medications to cancer patients who need them. Our pipeline position asked for several potential value-creating milestones through the end of 2022. Today, in addition to providing an update on our leading programs, we will spend a little bit of time to introduce you to AFM28, our most advanced preclinical innate cell engager, which is expected to enter the clinic in 2022. On slide three of the presentation that we made available to accompany our call today, We summarize ultimate strategy for developing our inner cell engagement. We introduced our three-pronged development strategy to you about a year ago. As we said to you then, we believe this strategy allows us to explore different development approaches, thereby increasing the probability of success for each of our molecules. What we have learned to date about the safety of our molecules is indeed supporting not just monotherapy, but also combination approaches. The first approach, where the patient's own innate immune system is still functional, indeed involves developing our innate delineator molecules as monotherapy. Our combination therapy approach involves pursuing novel therapeutic combinations, including combinations with NK cell therapy and other IO to IO therapies, such as checkpoint inhibitors. In the case of NK cell combinations, the combined cells create CAR-like NK therapeutics that seek out and destroy tumors. An example of that is our investigator-sponsored clinical trial at MD Anderson Cancer Center. On slide four, we are showing where we are with our leading inertial engages. AFM13 and AFM24, and the recently added AFM28 in a nutshell. All three of these innate cell engagers bind to CD16A on natural killer cells and macrophages with high affinity and also bind on specific targets on cancer cells to bring the innate immune system to fight against cancer. This slide shows our ASM13 inert and engaged target CD30 positive lymphoma, ASM24, EGFR-expressing solid tumors, and ASM28. Our nearest candidate, CD123 positive AML indications. We are embarking on a broad development strategy for each of our molecules, which we believe we will be which we believe will be the basis for continuous data flow from our pipeline over the next several quarters. Since we introduced you to our three-pronged strategy, we've also made a lot of progress to support our claims. We have published clinical and preclinical data that make us quite confident about the path that we have set for our company. Our goal in all of these efforts at ApiMed is to bring innovative therapies to cancer patients who are often out of these options when it comes to managing their disease. These are very sick patients who frequently see their disease return after multiple lines of treatment. Very proud to have been able to offer these undeserved and frequently without hope patients another opportunity to fight their disease. And as we have shown, for example, with AFM13, and in particular, in combination with natural kinesis. With that introduction, Let me give you a quick update on our program. Jumping now to slide six. This shows a snapshot of where we are with AFEM 13. Our registration-directed study of AFEM 13 monotherapy in relapsed refractory peripheral T-cell lymphoma is on track to complete enrollment in the first half of 2022, and we expect to provide guidance about timing for data as we get closer to the completion of enrollment. We're also very pleased to share with you that the investigator-sponsored clinical trial at MD Anderson Cancer Center evaluating cold blood-derived natural killer cells pre-complex with AFM13. It's going very well. As of October 31st, a total of 18 patients have now been enrolled in this study, including 12 patients at the highest dose, where we use 10 to the 8 in case of per-kilogram patients' body weight. We can confirm that no dose-limiting toxicities have been observed, and we continue to be encouraged by the response rate. To date, our key learnings are that the dosing regime is well-tolerated and can drive robust anti-tumor responses in heavily pre-treated patients. Our goal is to continue to gather robust data on safety and efficacy, and according to MDM Anderson, have submitted a protocol amendment to allow for an expansion of this study to treat up to 40 patients at the highest dose, now including Hodgkin lymphoma patients and CG30 positive non-Hodgkin lymphoma patients. Finally, we plan to present updated data from this study at a company-sponsored event in mid-December and expect to provide additional details on the date and time for this event in the coming weeks. We're also very excited about our progress with AFM24, where we believe the execution of our three-pronged strategy will allow for a continuous data flow of data over the course of the next several quarters. Andreas, our Chief Medical Officer, will now tell you more about where we are with AFM24. Andreas?