Affimed N.V.

Good day, and thank you for standing by. Welcome to the Affirm AFIMED first quarter 2022 financial results corporate update conference call. At this time, all participants are in a 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. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to Alex Sudeikides, Head of Investor Relations. Please go ahead, sir.

Thank you, Norma, and thank you all for joining us for our call today. Before we begin, I'd like to remind everyone that we posted the relevant press release and presentation on the Investor Relations section of our website earlier today. 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 Chatelius, our Chief Scientific Officer, Wolfgang Fischer, our Chief Operating 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 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 our filings 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 thanks a lot for joining us for this call today. I'd like to take a moment to review what we have achieved so far, especially against the challenging backdrops like the global pandemic, geopolitical tension, and volatility in the capital market. In the last few years, we have built a differentiated therapeutics pipeline of innate cell engagers, established a clinical proof of concept for our three-pronged development strategy, reinforced our senior leadership team and strengthened our balance sheet. More recently, we presented highly meaningful proof of concept data for our pioneering approach of treating heavily pre-treated patients with a combination of an inertial engager and allogeneic natural killer cells. We also recognize the need to build a solid financial base to allow now swift execution of our programs they're very pleased to have recently completed the 103.5 million public offering with these proceeds we have the resources required to move our key wholly owned programs just mention them here a from 13 a from 24 and a from 28 to important inflection points over the next 12 to 18 months In the first quarter of this year, we announced the completion of enrollment of our redirect study, which treats patients with relapsed refractory peripheral T-cell lymphoma with AFM13 monotherapy. We expect to report the top-line data from this study in the fourth quarter of this year. For the AFM13 study in combination with natural killer cells, Following the compelling data that were reported in December of last year, we presented updated data at AACR and we showed a strong increase in complete responses after two cycles of therapy at the recommended phase two dose and very encouraging signs of durability. We believe these data continue to validate the program and the overall approach. The data presentations in December 2021 at AACR have led to an increased interest by the pharmaceutical industry and treating physicians. And as a result, MD Anderson has been enrolling additional patients with Hodgkin lymphoma and other CD30-positive non-Hodgkin lymphoma. We indeed had planned to present new data from this study on additional patients, including important correlative signs data at ASCO which we now plan to present at a medical conference in the second half of this year. Moving on, for AFEM24, our ETFR targeting units and engager, we continue to enroll patients in all three clinical trials based on our three-pronged development strategy, and we're planning to present data in the second half of this year. And for AFEM28, our CD123 targeting inner cell engager, we're on track to submit an R&D in June for clinic evaluation of patients with relapsed and refractory AML. We expect to initiate the phase one clinical trial in the second half of this year. We're also continuing to make progress in our work with our partners at MD Anderson, NKGEN and other third parties to ensure access to an off-the-shelf cryopreserved natural killer cells for further development with our ICE inner cell engager therapy. We expect to provide additional updates on our NK cell development strategy in the second half of 2022. We are advancing also our work with existing collaborators. In the case of Genentech, we have made good progress in various preclinical programs and handed over several programs to them for further preclinical development. Through our partnership with Roivant, AFM32 is currently being investigated in ING enabling studies. We are eligible for additional proceeds from these key collaborations in the near term, including preclinical milestones as well as milestones based on early regulatory achievements. We are also very encouraged by the data presented by our peers in the innate immune field and the interest from the pharmaceutical industry in therapies based on innate immunity. There is a growing recognition that engaging the innate immune system can play an important role in fighting cancer and we are particularly proud to be among the first companies to have produced positive clinical data through this approach. As our data have shown, our three-pronged approach has the potential to provide benefit to patients that have very limited treatment options and indeed urgently need novel treatment. We aim to bring our drugs forward to registration-directed studies in the near future, and we believe this is creating a strong commercial opportunity