Affimed(AFMD) - 2019 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q3 2019 with €76.5 million in cash, down from €108.8 million at the end of 2018, but pro forma cash position including a recent equity offering is approximately €106 million [22] - Net cash used in operating activities increased to €30.6 million for the nine months ended September 30, 2019, compared to €24.9 million for the same period in 2018, primarily due to higher R&D expenditures [23] - Total revenue for Q3 2019 was €2.1 million, a significant increase from €300,000 in Q3 2018, attributed to revenue recognition from the Genentech collaboration [23] Business Line Data and Key Metrics Changes - R&D expenses for Q3 2019 were €11.7 million, up from €9.8 million in Q3 2018, mainly due to increased manufacturing activities for clinical study materials and startup activities for AFM13 [24] - General and administrative expenses rose to €2.8 million in Q3 2019 from €2.4 million in Q3 2018 [24] - The net loss for Q3 2019 was €10.9 million, or €0.17 per share, compared to a net loss of €12 million, or €0.19 per share, in Q3 2018 [24] Market Data and Key Metrics Changes - The company is expanding its clinical programs across multiple regions, including the U.S., Europe, and Asia Pacific, with plans for over 70 sites for the AFM13 study [29] - The collaboration with Genentech has led to a milestone payment, indicating strong market interest and potential for future revenue generation [13] Company Strategy and Development Direction - The company is focused on advancing its clinical programs for AFM13 and AFM24, with a commitment to addressing unmet medical needs in cancer treatment [25] - The strategy includes broadening the early-stage pipeline with additional innate cell engagers and leveraging collaborations to enhance development capabilities [12][13] - The company aims to achieve data milestones in 2020 for all programs and collaborations, indicating a proactive approach to clinical development [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in clinical development and the strengthening of the balance sheet, positioning the company well for future operations [25] - The company highlighted the high unmet medical need in treating relapsed and refractory patients, particularly in the context of the AFM13 program [15] - Management acknowledged the challenges in predicting timelines for clinical trials due to the nature of the diseases being targeted, but remains committed to providing updates as progress is made [60] Other Important Information - The company has initiated a Phase 2 registration-directed study for AFM13, with the first patient dosed, marking a significant milestone [9] - The FDA has cleared the IND for AFM24, allowing the company to proceed with a Phase 1/2a clinical study targeting EGFR-expressing solid tumors [11][20] Q&A Session Summary Question: Update on Phase 2 registration-directed study and site rollout - Management confirmed that the first patient was treated at Columbia University and anticipates over 70 sites across the U.S., Europe, and Asia Pacific [29] Question: Timeline for the AFM13 and allogeneic NK cell combo trial - Management indicated that they cannot speculate on the timing of the investigator-sponsored trial but are in close communication with MD Anderson [31] Question: Details on AFM24 study enrollment and data reporting - The Phase 1 study is set to initiate in Q1 2020, with early safety data expected by late 2020 [34] Question: Impact of MD Anderson's licensing deal with Takeda on the NK cell program - Management clarified that the licensing event has no impact on their collaboration with MD Anderson and they are exploring commercialization options based on trial results [38][40] Question: AFM24's role in the treatment landscape for EGFR cancers - Management explained that AFM24 engages NK cells to kill tumors, potentially overcoming limitations of current EGFR-targeting therapies [45] Question: Future disclosure of targets for AFM28 and AFM32 - Management stated that they have not yet decided on the timing for disclosing targets for these new programs [48]