Affimed(US:AFMD)2023-03-23 19:04Financial Data and Key Metrics Changes - As of the end of 2022, the company had cash and cash equivalents of €190.3 million, a decrease from €197.6 million at the end of 2021 [31] - Total revenue for 2022 was €41.4 million, compared to €40.4 million in 2021, primarily from collaborations with Genentech and Roivant [31] - Research and development expenses increased by 21% from €81.5 million in 2021 to €98.8 million in 2022, driven by higher costs associated with AFM24 and AFM28 [31] - General and administrative expenses rose by 32% from €24.2 million in 2021 to €32.1 million in 2022, mainly due to higher personnel costs and consulting fees [31] - The net loss for 2022 was €86 million, or €0.60 per share, compared to a loss of €57.5 million, or €0.48 per share, in 2021 [32] Business Line Data and Key Metrics Changes - The AFM13 program showed a high overall response rate of 94% and a complete response rate of 71% in a Phase I/II study with 35 patients [17] - The AFM24 program is expected to report data from three studies in the second or third quarter of 2023, focusing on solid tumors [23] - The AFM28 program is now open for patient enrollment in four European countries, targeting CD123 positive myeloid malignancies [27] Market Data and Key Metrics Changes - The company is focusing on the U.S. and European markets for its clinical trials, particularly in the oncology sector [34] - The collaboration with Artiva for NK cell therapy is expected to enhance the company's market position in treating relapsed/refractory Hodgkin's lymphoma [21] Company Strategy and Development Direction - The primary focus for 2023 is the execution of the AFM13 AB-101 clinical development plan, with plans to submit an IND and initiate a clinical study [11] - The company aims to leverage its unique innate cell engagers to differentiate itself from competitors in the immunotherapy space [8] - The strategy includes advancing combination therapies to improve efficacy and patient outcomes, particularly in underserved cancer populations [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made across all pipeline projects and the potential for significant milestones in 2023 [34] - The company is committed to addressing the needs of patients with limited treatment options, particularly in the oncology field [12] - Management highlighted the importance of collaborations and partnerships in enhancing the company's clinical development capabilities [34] Other Important Information - The company plans to provide updates on clinical trials and data presentations at upcoming scientific conferences [34] - The management team emphasized the importance of patient outcomes in guiding their research and development efforts [12] Q&A Session Summary Question: Timing and patient expectations for AFM24 data - Management confirmed that they are targeting several conferences in Q2 and Q3 for data updates and that patient populations will primarily consist of those with prior treatment failures [36][39] Question: IND filing timeline for AFM13 - Management indicated that they expect to file the IND in the first half of the year and are already preparing sites for patient treatment [43][48] Question: Efficacy expectations for AFM24 monotherapy - Management stated that go/no-go decisions will be based on response rates and duration of responses, with further guidance expected as data matures [52][54] Question: Enrollment progress for AFM28 - Management confirmed that the study is open for enrollment, but no specific data has been released yet [57] Question: Rationale for exploratory cohorts in AFM13 - Management explained that the study includes both Hodgkin lymphoma and peripheral T-cell lymphoma patients to evaluate response rates [70][71]