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]

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 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 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 ...

Product Development - The company is focused on developing highly targeted cancer immunotherapies using its proprietary ROCK® platform, which enables the creation of next-generation bispecific antibodies [282]. - The lead product candidate, AFM13, is designed to engage innate immune cells and has shown a 1,000-fold higher affinity for CD16A compared to native antibodies, targeting relapsed/refractory Hodgkin lymphoma and CD30-positive lymphoma patients [298]. - The company has established a clinical pipeline with five programs, three of which retain global commercial rights, focusing on orphan or high-medical need indications [285]. - AFM11, another lead product candidate, has shown promising results in preclinical studies and has treated 33 patients across two clinical Phase 1 studies for relapsed/refractory non-Hodgkin lymphoma and acute lymphocytic leukemia [299]. - AFM24 completed a toxicology study in cynomolgus monkeys at doses up to 75 mg/kg with no observed toxicities, contrasting with significant toxicity seen in Cetuximab [319]. - AFM13 achieved an objective response rate (ORR) of 88% in a phase 1b study, with complete metabolic responses in 46% of patients [312]. - AFM13 demonstrated tumor shrinkage or slowing of tumor growth in 16 of 26 patients eligible for efficacy evaluation, with complete remissions in 3 of 11 patients treated in the highest dose cohorts [308]. - The company is conducting two phase 1 clinical studies of AFM11, with a total of 33 patients treated across both studies [318]. - AFM13 is being investigated in combination with Merck's anti-PD-1 antibody Keytruda, with a focus on enhancing therapeutic efficacy [314]. - The phase 1b clinical study of AFM13 in combination with Keytruda® showed an overall response rate (ORR) of 88% in 24 patients, with complete metabolic responses in 46% and partial metabolic responses in 42% [378]. - The phase 1 clinical study of AFM13 enrolled 28 patients, with a median of six prior lines of therapy, and demonstrated anti-tumor activity at doses of 1.5 mg/kg and above, achieving an overall response rate of 23% in a subgroup [383][385]. - AFM13 treatment resulted in a dose-proportional increase in systemic exposure, with a mean half-life of 9-19 hours for the 1.5 mg/kg cohort, and was detectable in peripheral blood up to 168 hours post-infusion [389]. - The company plans to initiate a phase 2b study for AFM13 in relapsed/refractory Hodgkin Lymphoma, which could support an application for registration based on high medical need [392][393]. - AFM13 demonstrated a favorable safety profile, with less than 30% of adverse events classified as severe, primarily consisting of mild to moderate fever and chills [384]. Collaborations and Partnerships - Collaborations with organizations like the Leukemia and Lymphoma Society and Merck aim to expedite development and patient enrollment for AFM13 [294]. - The collaboration with MD Anderson aims to evaluate AFM13 in combination with cord-blood derived NK cells, with plans for a clinical study in relapsed/refractory CD30-positive lymphoma patients [398]. - The collaboration with Genentech resulted in an initial payment of $96 million and potential milestone payments totaling approximately $5.0 billion, including $250 million for development activities [418][421]. - Genentech is responsible for the majority of research, development, and commercialization costs for the licensed product candidates under the collaboration agreement [422]. - The Leukemia & Lymphoma Society (LLS) agreed to co-fund the clinical development of AFM13 with contributions up to approximately $4.4 million, of which $4.2 million has already been received [437]. - The research funding agreement with LLS was amended to prioritize the development of AFM13 as a combination therapy following a collaboration with Merck [437]. Market and Competitive Landscape - The biopharmaceutical industry is characterized by intense competition, with many companies developing therapies for cancer disorders, including major pharmaceutical and biotechnology firms [471]. - The company faces potential competition from established therapies and new entrants, which may impact its market position and commercial opportunities [479]. - There are approximately 9,000 new cases of Hodgkin Lymphoma (HL) in the United States annually, with about 4,000-5,000 patients being refractory to or relapsing from standard therapy [351][352]. - Approximately 6,000 to 8,000 relapsed/refractory cancer cases per year in North America, the European Union, and Japan are attributed to CD30+ hematological malignancies [355]. - The total annual incidence of all B cell lymphoma subtypes in North America, the European Union, and Japan is about 160,000 cases, with DLBCL alone representing about 46,000 new patients annually [357]. Financial and Funding - The company received a €2.4 million ($3 million) grant from the German Federal Ministry of Education and Research, covering approximately 40% of funding for a multi-specific antibody development program [350]. - The agreement with Amphivena included milestone payments totaling €7.5 million, with the first three milestones successfully reached [427]. - As of December 31, 2018, the company had invested a total of $4.0 million in Amphivena, owning approximately 7% of its outstanding equity [428]. - Amphivena received €14.5 million in payments for research and development services under the license and development agreement, which has now expired [429]. Intellectual Property - The company has developed a strong patent portfolio in bispecific antibody therapeutics, supporting both internal development and potential out-licensing opportunities [305]. - The patent portfolio for AFM13 includes three families, with the first patent family expiring in 2019 and the second in 2020 [451][452]. - The patent portfolio for AFM11 includes one family granted in multiple countries, with patents expiring in 2019 and others expiring in 2030 or 2031 [453]. - The patent portfolio for AFM24 includes patents on the TandAb format, with some patents expiring in 2026 [454]. - The immune cell engager platform patent portfolio includes patents expiring in 2019 and 2030, covering various therapeutic uses for viral, bacterial, and tumoral diseases [456]. - Patent applications for trispecific antibody formats were submitted in 2015 and 2016 across multiple countries, indicating ongoing development in this area [457]. - The company has out-licensed patents covering the BCMA/CD16A compound, which includes a granted patent family similar to other TandAb formats [455]. - Exclusive and non-exclusive patent and know-how license agreements have been established, which include obligations for development milestones and sales royalties [459]. - The FDA allows for patent term extensions of up to five years for approved drugs, which the company plans to pursue for its products upon receiving approval [460]. Company Operations - The company employs 69 personnel at its main offices in Heidelberg, with approximately 60% holding advanced academic degrees [288]. - The company aims to leverage its technology platforms to continue building its cancer immunotherapy pipeline and enhance its intellectual property portfolio [293]. - The company plans to build a commercial sales force in the U.S. and Europe to market its product candidates upon regulatory approval [286]. - A focused sales and marketing organization will be built prior to receiving marketing approvals to effectively target oncologists [469]. - The company relies on contract manufacturing organizations (CMOs) for drug substance and product, ensuring compliance with Good Manufacturing Practice (GMP) regulations [466]. - The AFM13 manufacturing process has been successfully scaled to meet clinical demands, with ongoing efforts to establish commercial-scale production [467]. Clinical Insights - The management team has extensive experience in the biopharmaceutical industry, contributing to the development and commercialization of several approved drugs [304]. - Cancer immunotherapy is increasingly significant, with various approaches including vaccinations and checkpoint modulators being explored [334]. - The projected medical costs associated with cancer reached $125 billion in 2010, expected to increase by 27% to at least $158 billion by 2020 [330]. - The 5-year relative survival rate for all cancers diagnosed from 2008-2014 was 69% [330]. - Adcetris® treatment in relapsed/refractory Hodgkin lymphoma (HL) patients resulted in an overall response rate of 75% and a complete response rate of 34% [354]. - The median progression-free survival after Adcetris® is only 9.3 months, with considerable adverse events like neutropenia and neuropathy [354]. - Nivolumab and pembrolizumab show overall response rates of 64% to 74% in relapsed/refractory classical HL patients post-brentuximab vedotin, with complete remission rates of 12% to 25% [355]. - The pivotal "TOWER" study showed that 76% of patients treated with blinatumomab achieved complete remission and were MRD negative, compared to 48% for chemotherapy [402]. - AFM11 demonstrated a 100-fold higher affinity to the CD3 receptor than a reference BiTE molecule, maintaining cytotoxic potency even at lower effector cell to tumor cell ratios [403]. - The company’s immune cell engagers bind to immune cells with approximately 1,000-fold higher affinity than IgG-based antibodies, enhancing the activity of innate immune cells [343]. - The company’s T cell engager lead candidate AFM11 binds to CD3 and CD19, demonstrating target-dependent cytotoxicity at low picomolar concentrations [348]. - AFM13 is a first-in-class innate cell engager targeting CD30, showing higher cytotoxic potency than native anti-CD30 antibodies [372]. - AFM13 has been granted orphan drug status for the treatment of HL in the United States and the European Union [377]. - The clinical development of AFM13 includes a revised study design to adapt to the availability of anti-PD-1 antibodies, focusing on heavily pretreated patient populations [377].