Affimed(AFMD)2024-11-14 19:32Financial Data and Key Metrics Changes - The company ended Q3 2024 with cash, cash equivalents, and investments of €24.1 million, down from €72 million on December 31, 2023 [23] - Total revenue for Q3 2024 was €0.2 million, compared to €2.0 million in Q3 2023 [24] - R&D expenses for Q3 2024 were €10.1 million, down from €21.5 million in the same quarter of 2023 [24] - General and administrative expenses for Q3 2024 were €4.3 million, compared to €5.4 million in Q3 2023 [25] - The net loss for Q3 2024 was €15.1 million, or €0.94 loss per share, compared to a net loss of €24.4 million, or €1.63 loss per share, in Q3 2023 [25] Business Line Data and Key Metrics Changes - The AFM24 program is progressing well, with both EGFR wild-type and mutant cohorts fully enrolled and actively treating patients [17] - The AFM28 program has shown promising monotherapy results, with no dose-limiting toxicities observed at the 300 mg weekly dose level [20] Market Data and Key Metrics Changes - The company is focusing on treatment-refractory non-small cell lung cancer patients, with a median progression-free survival of 5.9 months reported for the EGFR wild-type cohort [18] - The company is also targeting patients with relapsed refractory acute myeloid leukemia (AML) with its AFM28 program, which is expected to provide a chemotherapy-free alternative for patients who have failed multiple lines of treatment [19] Company Strategy and Development Direction - The company aims to deliver therapies that demonstrate strong clinical efficacy and have a meaningful impact on treatment paradigms while being commercially sustainable [13] - The management is pursuing a wider range of potential collaborations to broaden strategic options and engage with a diverse set of partners [13] - The company is committed to improving its financial health and ensuring it is well-capitalized to support clinical development [14] Management's Comments on Operating Environment and Future Outlook - The management expressed confidence in the company's ability to navigate the challenging market environment and secure necessary capital for progress [25] - The management highlighted the importance of partnerships in accelerating progress and emphasized the need for differentiated clinical data from ongoing trials [14][15] Other Important Information - The company plans to present key clinical updates at the ASH 2024 conference, including data from the AFM28 and AFM24 programs [11][12] - A dedicated conference call for AFM24 updates is scheduled for December 17, 2024 [12] Q&A Session Summary Question: Durability expectations for AFM28 data at ASH - Management indicated that six patients reported at the last earnings call will have a meaningful observation period to assess durability of responses, while additional patients may not have sufficient follow-up for meaningful conclusions [26][27] Question: Registration path for AFM28 - Management stated that they are planning to add higher-dose cohorts to capture full therapeutic potential and will consider going to the FDA based on data maturation [28][30] Question: Broadened collaboration strategy - Management clarified that they are evaluating a variety of strategic partnerships, including regional deals, to create additional optionality for non-dilutive capital [32][33] Question: Development path for AFM24 - Management noted that they are waiting for data maturity from the AFM24 program and considering various combinations for future trials [34][35] Question: Data expectations for AFM24 in December - Management confirmed that the focus will be on response rates in December, with mature PFS data expected in the first half of 2025 [37][41] Question: Partnership discussions for AFM24 - Management is open to discussing partnerships for all innate cell engager programs and is looking for more mature data to gain confidence from potential partners [65]