Affimed(US:AFMD)2023-08-10 15:57Financial Data and Key Metrics Changes - As of June 30, 2023, cash and cash equivalents totaled EUR120.1 million, down from EUR190.3 million as of December 31, 2022 [31] - Net cash used in operating activities for Q2 2023 was EUR33.3 million, compared to EUR26.5 million in Q2 2022 [32] - Total revenue for Q2 2023 was EUR1.4 million, a significant decrease from EUR7.3 million in Q2 2022 [33] - Net loss for Q2 2023 was EUR29.4 million or EUR0.20 per common share, compared to a net loss of EUR19.4 million or EUR0.13 per common share in Q2 2022 [35] Business Line Data and Key Metrics Changes - R&D expenses increased by 21.3% from EUR20.8 million in Q2 2022 to EUR25.3 million in Q2 2023, primarily due to higher costs associated with the development of AFM13 and AFM24 [33] - G&A expenses decreased by 25.1% from EUR8.4 million in Q2 2022 to EUR6.3 million in Q2 2023, attributed to a decline in legal, consulting, and insurance expenses [34] Market Data and Key Metrics Changes - The company is focusing on the development of AFM13 in combination with AB101 for Hodgkin lymphoma, with initial data expected in the first half of 2024 [12][15] - AFM24 showed promising activity in heavily pretreated patients with EGFR mutant non-small cell lung cancer, with two partial responses and five stable diseases observed [10][22] Company Strategy and Development Direction - The company is pursuing innovative treatments for cancer, focusing on innate cell engager molecules and their combinations with allogeneic NK cells and checkpoint inhibitors [8] - The strategic focus includes advancing clinical trials for AFM13, AFM24, and AFM28, with several upcoming inflection points anticipated over the next 12 months [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the financial stability to execute the business plan into 2025, allowing for continued innovation in cancer treatment [12] - The company is preparing for a Type C meeting with the FDA to discuss the requirements for accelerated approval based on the LuminICE-203 study [41][76] Other Important Information - The company has completed its contractual obligations under collaborations with Genentech and Roivant, which may lead to reduced revenue in the short term [63] - The company is evaluating options to advance AFM24 with an allogeneic off-the-shelf NK cell product [26] Q&A Session Summary Question: What data from the AFM13-203 study could be shown to the FDA by the Type C meeting? - Management indicated that the Type C meeting will focus on the contribution of single agents and not on initial data from the 203 study [41][42] Question: What components is the FDA inquiring about regarding the contribution? - The FDA is asking for the contribution of single agents, including AFM13, AB101, and IL-2 [49][50] Question: Will the confirmatory study be discussed in the Type C meeting? - The confirmatory study will not be discussed in the Type C meeting; the focus will be on the contribution of single agents [88] Question: What is the likelihood that the FDA might say to wait for early preliminary data before discussing? - The risk of the FDA requesting to wait for early data is considered small, as the meeting is specifically to address the contribution of single agents [72] Question: What should be anticipated for the data release in the first half of 2024? - The initial update will focus on safety and response rates, with expectations to enroll 24 patients across the cohorts [61]