Affimed(AFMD)2024-09-05 15:17Financial Data and Key Metrics Changes - The company ended Q2 2024 with cash, cash equivalents, and investments of €34.4 million, down from €72 million at the end of 2023 [24] - Net cash used in operating activities for Q2 2024 was €16.5 million, compared to €33.3 million in Q2 2023 [25] - Total revenue for Q2 2024 was €0.2 million, a decrease from €1.4 million in Q2 2023 [25] - R&D expenses for Q2 2024 were €11.7 million, down from €25.3 million in 2023 [25] - G&A expenses for Q2 2024 were €4 million, compared to €6.3 million in Q2 2023 [25] - The net loss for Q2 2024 was €15.5 million, or €1.01 per share, compared to a net loss of €29.4 million, or €1.97 per share, in Q2 2023 [25] Business Line Data and Key Metrics Changes - The AFM24-102 trial for non-small cell lung cancer is nearing full enrollment, with early efficacy data showing a 23.5% objective response rate and a 70.6% disease control rate in the EGFR mutant cohort [16][17] - The acimtamig (AFM13) program in multi-refractory Hodgkin's lymphoma shows an 83.3% response rate, with 50% achieving complete response [19] - The AFM28 program for acute myeloid leukemia has shown a 50% complete response rate at the highest dose level, indicating a potential dose-response relationship [22] Market Data and Key Metrics Changes - The company sees over 14,000 patients per year in the seven major markets who fail at least two lines of standard therapy for acute myeloid leukemia, indicating a significant unmet medical need [23] Company Strategy and Development Direction - The new CEO emphasizes the importance of securing funding to support clinical programs and expanding partnerships with pharmaceutical companies [9][10] - The company aims to achieve operational efficiency and continuous improvement to deliver value to stakeholders [10] - There is a focus on exploring innovative partnerships to enhance clinical development and patient access to therapies [10] Management's Comments on Operating Environment and Future Outlook - The management acknowledges the challenging capital markets for biotechs in 2024 but expresses confidence in the company's compelling clinical data [9] - The CEO is committed to increasing shareholder value through successful execution of clinical programs and forging new partnerships [29] Other Important Information - The company plans to disclose data from all four cohorts of the acimtamig study at a scientific meeting in Q4 2024 [20] - The company anticipates that cash and equivalents will finance operations into the second half of 2025 [24] Q&A Session Summary Question: Differences in AFM24 data among patients with prior TKIs - Management confirmed no observed differences in response rates between patients who had prior third-generation TKIs and those with first- or second-generation TKIs [33] Question: Expectations for higher NK cell dose in LuminICE study - Management indicated no differences in response rates between the 200 mg and 300 mg doses so far, with further data expected in Q4 2024 [36] Question: Development strategy for AFM28 and AFM24 - Management highlighted the encouraging monotherapy activity of AFM28 and the potential for combination therapies, emphasizing a data-driven approach for future development [42][45] Question: Durability of response threshold for AML - Management stated that a meaningful response would be a progression-free survival of around six months in heavily pretreated patients [49] Question: Mutations in AML patients treated with AFM28 - Management noted that the mutation patterns observed are representative of a pretreated AML population, with detailed data to be released in Q4 [53] Question: Enrollment progress for cohorts 3 and 4 - Management expressed satisfaction with enrollment progress, attributing it to improved site training and increased site participation [60]