Affimed(US:AFMD)2019-08-08 07:08Financial Data and Key Metrics Changes - Cash, cash equivalents, and current financial assets totaled EUR87.7 million as of June 30, 2019, down from EUR108.8 million as of December 31, 2018, indicating a decrease in liquidity [20] - Total revenue for the three months ended June 30, 2019, was EUR4 million, a significant increase from EUR0.2 million for the same period in 2018, primarily due to revenue recognition from the Genentech collaboration [21] - Net loss for the second quarter of 2019 was EUR10.3 million or EUR0.17 per common share, compared to a net loss of EUR8 million or EUR0.13 per common share for the same quarter in 2018 [22] Business Line Data and Key Metrics Changes - R&D expenses for the second quarter of 2019 were EUR11.5 million, up from EUR7.1 million in the same quarter of 2018, driven by increased manufacturing activities and clinical study preparations [21] - G&A expenses remained nearly unchanged at EUR2.3 million compared to EUR2.2 million in the second quarter of 2018 [22] Market Data and Key Metrics Changes - The company is focusing on the U.S. and Germany markets, strengthening its organization by hiring experienced personnel from major pharmaceutical companies to enhance drug development capabilities [6][17] Company Strategy and Development Direction - The company is committed to advancing its CD16A-targeting innate cell engagers, aiming to transform current immuno-oncology approaches by leveraging the innate immune system [5][6] - The AFM13 registration-directed Phase II study is a key focus, with plans to initiate the study in the second half of 2019, targeting patients with relapsed or refractory peripheral T cell lymphoma [9][10] - The company is also advancing AFM24, designed to target EGFR-expressing solid tumors, with a novel mechanism of action that activates innate immunity [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of AFM13 and AFM24 to address unmet medical needs in oncology, particularly in populations with limited treatment options [10][12] - The company anticipates that its current cash position will fund clinical development activities into 2021, indicating a stable financial runway [20][22] Other Important Information - The collaboration with Genentech is progressing well, with a payment received for achieving a preclinical milestone [17] - The company is exploring opportunities to combine its innate cell engagers with NK cell therapies to enhance treatment efficacy [15][16] Q&A Session Summary Question: What are the positive endpoints needed for AFM13's accelerated approval? - The primary endpoints are objective response rate and durability of response, with expectations based on previous approvals in similar populations [25] Question: When can initial data from the AFM13 study be expected? - Initial data is anticipated next year, with disclosure planned at the time of the interim analysis [28] Question: Are there plans to evaluate AFM24 in combination with other agents? - The company plans to establish AFM24's single-agent activity before exploring combination strategies, with potential combinations depending on tumor type [30] Question: What technical issues were raised by the FDA regarding the AFM13 trial? - Feedback included details on eligibility criteria, statistical analyses, and defining CD30 positivity, all of which were addressed in the final protocol [32][46] Question: What roles were filled with new hires? - New hires included positions in clinical operations, biostatistics, drug safety, and regulatory affairs, aimed at strengthening the organization for upcoming studies [48][50]