Affimed(US:AFMD)2024-03-28 16:04Financial Data and Key Metrics Changes - Affimed ended 2023 with cash, cash equivalents, and investments of €72 million, a decrease from €190.3 million on December 31, 2022 [18] - Net cash used in operating activities for 2023 was €110.3 million, compared to €104.9 million in 2022 [19] - Total revenue for 2023 was €8.3 million, down from €41.4 million in 2022, primarily due to the completion of work under collaboration agreements with Roivant and Genentech [19] Business Line Data and Key Metrics Changes - The company focused on three clinical assets: AFM24, Acimtamig, and AFM28, with significant milestones achieved in 2023 [6][9] - AFM24 showed clinical activity in combination with atezolizumab, particularly in non-small cell lung cancer, with a disease control rate of 73% in the EGFR wild-type cohort [11][12] - Acimtamig's LuminICE-203 study was initiated, reflecting FDA feedback and Fast Track Designation [7] - AFM28's dose escalation study is progressing, with recruitment underway in the final dose cohort [8] Market Data and Key Metrics Changes - The company is targeting unmet medical needs in non-small cell lung cancer patients who have failed standard therapies, including platinum-based chemotherapy and PD-1 targeting therapy [7] - The standard of care for patients with platinum and PD-1 refractory disease typically results in an average progression-free survival of around 4.5 months [13] Company Strategy and Development Direction - Affimed implemented a significant restructuring initiative in January 2024, reducing its workforce by approximately 50% to focus on clinical development and regulatory operations [9] - The company aims to drive momentum in its clinical programs and achieve critical data milestones in 2024 [9][20] - Future data readouts are expected for both non-small cell lung cancer cohorts in Q2 2024 and the full 40-patient cohort in Q4 2024 [22] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges in the broader biotech industry but emphasized the resilience and commitment to advancing innovative therapies [6] - The groundwork laid in 2023 is expected to enable meaningful data readouts in 2024 and beyond [20] - The company remains focused on delivering innovative treatments for patients and increasing shareholder value [22] Other Important Information - The company retained key competencies in NK cell biology and ICE manufacturing in-house despite workforce reductions [9] - The median follow-up for the initial cohort of AFM24 is now six months, with final progression-free survival data expected around Q2 2024 [12] Q&A Session Summary Question: Clarity on LuminICE-203 patient data and Safety Review Committee meeting - Management confirmed no additional conversations with the FDA are needed before moving into Cohorts 3 and 4, and expects to report data from 12 patients in Q2 [25][26] Question: Expectations for translational data in Q2 update - Management indicated that the focus will be on clinical data, particularly progression-free survival in the initial non-small cell lung cancer cohort [30][33] Question: Experience with AFM13 trial and data update venue - Management will provide updates on safety and efficacy in Q2, with the venue for AFM24 data disclosure yet to be determined [38] Question: Focus on AFM28 and potential partnerships - Management confirmed the focus will be on development in combination with allogeneic NK cells, with an update planned for Q2 [40] Question: Patient dropout reasons in AFM13 trial - Dropout reasons were heterogeneous and not related to treatment, with some patients acquiring infections during the screening period [43]