Affimed(US:AFMD)2021-09-08 18:24Financial Data and Key Metrics Changes - The company ended Q2 2021 with cash and cash equivalents of €222.7 million, up from €146.9 million at the end of 2020 [26] - Net cash used in operating activities for Q2 2021 was €17.3 million, compared to €15 million in Q2 2020 [27] - Total revenue for Q2 2021 was €9.7 million, significantly higher than €2.9 million in Q2 2020, primarily from collaboration revenue [27] - Net loss for Q2 2021 was €18.8 million or €0.16 per share, compared to a net loss of €12.2 million or €0.16 per share in Q2 2020 [29] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2021 increased to €21.8 million from €11.7 million in Q2 2020, driven by costs associated with AFM24 and other early-stage programs [27] - General and administrative expenses rose by 109% to €5.4 million from €2.6 million in Q2 2020, largely due to higher personnel and consulting expenses [28] Market Data and Key Metrics Changes - The company is focusing on a three-pronged approach for its pipeline, targeting indications for AFM13, AFM24, and AFM28, with ongoing clinical trials showing promising results [7][12] Company Strategy and Development Direction - The company aims to advance its innate cell engagers to enable immune cells to identify and eliminate cancer cells, with a focus on broad sets of solid tumor indications [30] - For AFM13, the strategy includes targeting a wide range of CD30-positive lymphomas, while AFM24 is being developed for various solid tumors [30][31] - The company is also working on expanding its pipeline with additional product candidates from its ROCK platform [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of their therapies, highlighting the unique mechanisms of action of their products compared to conventional therapies [11][19] - The company anticipates multiple inflection points in the AFM24 program and plans to initiate several studies in 2021 [12][17] Other Important Information - The company has signed a CDMO for the manufacturing of NK cells and is generating data on cryopreserved NK cells pre-complexed with AFM13 [10] - The ongoing trials are designed to assess the safety and efficacy of their therapies, with plans for data updates at major medical conferences [9][19] Q&A Session Summary Question: Confirmation of stable disease in patients and correlation with EGFR expression - Management confirmed stable disease in several patients beyond eight weeks but noted no correlation between EGFR expression and clinical parameters [33][35] Question: Inflection points for AFM24 program - Management identified starting dose expansion cohorts and initiating combination studies as key inflection points [36][37] Question: Responses at the highest dose for AFM13 plus NK cell combo - Management has not disclosed specific details but indicated encouraging responses and ongoing patient enrollment at the highest dose [40][41] Question: Registration discussions with FDA - Management stated that discussions with the FDA would depend on the effect level observed in the study [42] Question: R&D expenditure modeling for the future - Management indicated that the current R&D expenditure level is likely more relevant for future modeling than previous quarters [60]