Affimed(AFMD)

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Affimed(AFMD) - 2019 Q3 - Earnings Call Transcript
2019-11-19 18:54
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]
Affimed(AFMD) - 2019 Q2 - Earnings Call Transcript
2019-08-08 07:08
Financial Data and Key Metrics Changes - Cash, cash equivalents, and current financial assets totaled EUR87.7 million as of June 30, 2019, down from EUR108.8 million as of December 31, 2018, indicating a decrease in liquidity [20] - Total revenue for the three months ended June 30, 2019, was EUR4 million, a significant increase from EUR0.2 million for the same period in 2018, primarily due to revenue recognition from the Genentech collaboration [21] - Net loss for the second quarter of 2019 was EUR10.3 million or EUR0.17 per common share, compared to a net loss of EUR8 million or EUR0.13 per common share for the same quarter in 2018 [22] Business Line Data and Key Metrics Changes - R&D expenses for the second quarter of 2019 were EUR11.5 million, up from EUR7.1 million in the same quarter of 2018, driven by increased manufacturing activities and clinical study preparations [21] - G&A expenses remained nearly unchanged at EUR2.3 million compared to EUR2.2 million in the second quarter of 2018 [22] Market Data and Key Metrics Changes - The company is focusing on the U.S. and Germany markets, strengthening its organization by hiring experienced personnel from major pharmaceutical companies to enhance drug development capabilities [6][17] Company Strategy and Development Direction - The company is committed to advancing its CD16A-targeting innate cell engagers, aiming to transform current immuno-oncology approaches by leveraging the innate immune system [5][6] - The AFM13 registration-directed Phase II study is a key focus, with plans to initiate the study in the second half of 2019, targeting patients with relapsed or refractory peripheral T cell lymphoma [9][10] - The company is also advancing AFM24, designed to target EGFR-expressing solid tumors, with a novel mechanism of action that activates innate immunity [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of AFM13 and AFM24 to address unmet medical needs in oncology, particularly in populations with limited treatment options [10][12] - The company anticipates that its current cash position will fund clinical development activities into 2021, indicating a stable financial runway [20][22] Other Important Information - The collaboration with Genentech is progressing well, with a payment received for achieving a preclinical milestone [17] - The company is exploring opportunities to combine its innate cell engagers with NK cell therapies to enhance treatment efficacy [15][16] Q&A Session Summary Question: What are the positive endpoints needed for AFM13's accelerated approval? - The primary endpoints are objective response rate and durability of response, with expectations based on previous approvals in similar populations [25] Question: When can initial data from the AFM13 study be expected? - Initial data is anticipated next year, with disclosure planned at the time of the interim analysis [28] Question: Are there plans to evaluate AFM24 in combination with other agents? - The company plans to establish AFM24's single-agent activity before exploring combination strategies, with potential combinations depending on tumor type [30] Question: What technical issues were raised by the FDA regarding the AFM13 trial? - Feedback included details on eligibility criteria, statistical analyses, and defining CD30 positivity, all of which were addressed in the final protocol [32][46] Question: What roles were filled with new hires? - New hires included positions in clinical operations, biostatistics, drug safety, and regulatory affairs, aimed at strengthening the organization for upcoming studies [48][50]
Affimed(AFMD) - 2019 Q1 - Earnings Call Transcript
2019-05-22 17:42
Affimed N.V. (NASDAQ:AFMD) Q1 2019 Earnings Conference Call May 22, 2019 8:30 AM ET Company Participants Gregory Gin - Head, Investor Relations Adi Hoess - Chief Executive Officer Florian Fischer - Chief Financial Officer Leila Alland - Chief Medical Officer Conference Call Participants Maurice Raycroft - Jefferies Jim Birchenough - Wells Fargo Peter Lawson - SunTrust Robinson Humphrey Daina Graybosch - SVB Leerink Yale Jen - Laidlaw Company Gregory Gin Thank you, Serena. Thank you for joining us today for ...
Affimed(AFMD) - 2018 Q4 - Earnings Call Transcript
2019-03-27 18:59
Affimed N.V. (NASDAQ:AFMD) Q4 2018 Earnings Conference Call March 27, 2019 8:30 AM ET Company Participants Greg Gin - Head of IR Adi Hoess - CEO Florian Fischer - CFO Leila Alland - CMO Conference Call Participants Maurice Raycroft - Jefferies Do Kim - BMO Capital Peter Lawson - SunTrust Yale Jen - Laidlaw Company Operator Good day and welcome to Affimed Full Year 2018 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. As a reminder, today's con ...
Affimed(AFMD) - 2018 Q4 - Annual Report
2019-03-27 11:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20‑F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . OR ☐ SHELL COMPANY REPORT PURSUANT TO SE ...