Affimed(AFMD)

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Affimed(AFMD) - 2021 Q2 - Earnings Call Transcript
2021-09-08 18:24
Financial Data and Key Metrics Changes - The company ended Q2 2021 with cash and cash equivalents of €222.7 million, up from €146.9 million at the end of 2020 [26] - Net cash used in operating activities for Q2 2021 was €17.3 million, compared to €15 million in Q2 2020 [27] - Total revenue for Q2 2021 was €9.7 million, significantly higher than €2.9 million in Q2 2020, primarily from collaboration revenue [27] - Net loss for Q2 2021 was €18.8 million or €0.16 per share, compared to a net loss of €12.2 million or €0.16 per share in Q2 2020 [29] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2021 increased to €21.8 million from €11.7 million in Q2 2020, driven by costs associated with AFM24 and other early-stage programs [27] - General and administrative expenses rose by 109% to €5.4 million from €2.6 million in Q2 2020, largely due to higher personnel and consulting expenses [28] Market Data and Key Metrics Changes - The company is focusing on a three-pronged approach for its pipeline, targeting indications for AFM13, AFM24, and AFM28, with ongoing clinical trials showing promising results [7][12] Company Strategy and Development Direction - The company aims to advance its innate cell engagers to enable immune cells to identify and eliminate cancer cells, with a focus on broad sets of solid tumor indications [30] - For AFM13, the strategy includes targeting a wide range of CD30-positive lymphomas, while AFM24 is being developed for various solid tumors [30][31] - The company is also working on expanding its pipeline with additional product candidates from its ROCK platform [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of their therapies, highlighting the unique mechanisms of action of their products compared to conventional therapies [11][19] - The company anticipates multiple inflection points in the AFM24 program and plans to initiate several studies in 2021 [12][17] Other Important Information - The company has signed a CDMO for the manufacturing of NK cells and is generating data on cryopreserved NK cells pre-complexed with AFM13 [10] - The ongoing trials are designed to assess the safety and efficacy of their therapies, with plans for data updates at major medical conferences [9][19] Q&A Session Summary Question: Confirmation of stable disease in patients and correlation with EGFR expression - Management confirmed stable disease in several patients beyond eight weeks but noted no correlation between EGFR expression and clinical parameters [33][35] Question: Inflection points for AFM24 program - Management identified starting dose expansion cohorts and initiating combination studies as key inflection points [36][37] Question: Responses at the highest dose for AFM13 plus NK cell combo - Management has not disclosed specific details but indicated encouraging responses and ongoing patient enrollment at the highest dose [40][41] Question: Registration discussions with FDA - Management stated that discussions with the FDA would depend on the effect level observed in the study [42] Question: R&D expenditure modeling for the future - Management indicated that the current R&D expenditure level is likely more relevant for future modeling than previous quarters [60]
Affimed(AFMD) - 2021 Q1 - Earnings Call Transcript
2021-07-01 19:14
Affimed N.V. (NASDAQ:AFMD) Q1 2021 Earnings Conference Call July 1, 2021 8:30 AM ET Company Participants Alexander Fudukidis - Head of Investor Relations Adi Hoess - Chief Executive Officer Arndt Schottelius - Chief Scientific Officer Angus Smith - Chief Financial Officer Andreas Harstrick - Chief Medical Officer Denise Mueller - Chief Business Officer Conference Call Participants Maurice Raycroft - Jefferies LLC Daina Graybosch - SVB Leerink LLC Nicholas Abbott - Wells Fargo Securities LLC Yale Jen - Laidl ...
Affimed(AFMD) - 2020 Q4 - Earnings Call Transcript
2021-04-15 19:31
Call Start: 08:30 January 1, 0000 9:30 AM ET Affimed N.V. (NASDAQ:AFMD) Q4 2020 Earnings Conference Call April 15, 2021 08:30 ET Company Participants Alexander Fudukidis - Head, Investor Relations Adi Hoess - Chief Executive Officer Angus Smith - Chief Financial Officer Andreas Harstrick - Chief Medical Officer Denise Mueller - Chief Business Officer Conference Call Participants Joseph Kim - Capital Markets Bradley Canino - Credit Suisse Yale Jen - Laidlaw & Co. Daina Graybosch - SVB Leerink Nick Abbott - W ...
Affimed(AFMD) - 2020 Q4 - Annual Report
2021-04-14 16:00
Use these links to rapidly review the document TABLE OF CONTENTS Index to consolidated financial statements AFFIMED N.V. (Exact name of Registrant as specified in its charter) Adi Hoess, Chief Executive Officer Tel: (+49) 6221-6743-60 Technologiepark, Im Neuenheimer Feld 582 69120 Heidelberg, Germany (Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) Technologiepark, Im Neuenheimer Feld 582 69120 Heidelberg, Germany, (+49) 6221-6743-60 (Address of principal executive off ...
Affimed(AFMD) - 2020 Q3 - Earnings Call Transcript
2020-11-10 19:46
Financial Data and Key Metrics Changes - The company ended Q3 2020 with cash, cash equivalents, and current financial assets of €97.3 million, down from €104.1 million at the end of 2019 [24] - Total revenue for Q3 2020 was €10.5 million, compared to €2.1 million in Q3 2019, primarily from the Genentech collaboration [25] - Net loss for Q3 2020 was €6 million, or €0.07 per share, compared to a net loss of €10.9 million, or €0.17 per share, in Q3 2019 [25] Business Line Data and Key Metrics Changes - R&D expenses for Q3 2020 were €10.1 million, down from €11.7 million in Q3 2019, focusing on AFAM 13 and AFAM 24 clinical programs [25] - The company reported significant progress on its clinical stage molecules, AFAM 13 and AFAM 24, with ongoing studies and patient recruitment [10][12] Market Data and Key Metrics Changes - The company has established new strategic partnerships, including a collaboration with Royden, which will provide €60 million in upfront consideration and potential future milestones of up to €2 billion [14][24] - The collaborations are expected to enhance the company's pipeline and provide significant non-dilutive funding [24] Company Strategy and Development Direction - The company aims to leverage its platform to broaden opportunities within its pipeline, focusing on three strategic components: developing alligator molecules, pursuing novel therapeutic combinations, and thoughtful partnering [8][9] - The company is actively exploring combination therapies with checkpoint inhibitors and other approaches to enhance treatment efficacy [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's strong cash position, which is expected to support operations into the first half of 2023 [24] - The company anticipates completing interim analyses for its clinical studies in the first half of 2021 and is excited about the potential of its pipeline [26][27] Other Important Information - The company has made substantial progress in its clinical programs and has received positive feedback from major conferences regarding its data [7][9] - The collaborations with industry innovators are expected to accelerate the development of the company's pipeline and enhance shareholder value [14][15] Q&A Session Summary Question: Can you explain the differences in response rates between NK cells from healthy donors and cancer patients? - Management indicated that preclinical studies have shown that NK cells from healthy donors exhibit better functionality and response rates compared to those from cancer patients [30] Question: How will the company determine which targets to assign to each partner? - The company clarified that target selection will depend on the discretion of the partners, provided the targets are not already part of the company's pipeline [32] Question: Will there be additional collaborations with commercial partners? - Management stated that while they are currently satisfied with their partnerships, they remain open to future collaborations based on ongoing progress and opportunities [36] Question: Is the dose escalation data from AFAM 24 still on track for reporting in the first half of 2021? - Management confirmed that the study is progressing as planned, although the exact number of dose levels required is still being determined [39] Question: How will the revenue from the recent collaboration be recognized? - The company anticipates that a portion of the revenue will be recognized in Q4 and the remainder will be amortized over time [50] Question: How will the company reconcile the efforts of different collaborations? - Management emphasized the importance of maintaining a broad approach in the field, leveraging their unique platform to explore multiple collaboration opportunities [52]
Affimed(AFMD) - 2020 Q2 - Earnings Call Transcript
2020-08-11 15:41
Affimed N.V. (NASDAQ:AFMD) Q2 2020 Earnings Conference Call August 11, 2020 8:30 AM ET Company Participants Alexander Fudukidis - IR Adi Hoess - CEO Andreas Harstrick - Chief Medical Officer Arndt Schottelius - Chief Scientific Officer Angus Smith - CFO Wolfgang Fischer - COO Denise Mueller - Chief Business Officer Conference Call Participants Maury Raycroft - Jefferies Jim Birchenough - Wells Fargo Ike Oji - BMO Capital Markets Yale Jen - Laidlaw & Company Operator Good day, and welcome to Affimed Second Q ...
Affimed(AFMD) - 2020 Q1 - Earnings Call Transcript
2020-06-23 14:50
Financial Data and Key Metrics Changes - The company ended Q1 2020 with €88.2 million in cash, down from €104.1 million as of December 31, 2019, but raised net proceeds of €18.8 million under its ATM program, bringing the pro forma cash position to €107 million [43][44]. - Net cash used in operating activities for Q1 2020 was €16.5 million, compared to €13.4 million in Q1 2019, primarily due to increased R&D expenditures [44]. - Total revenue for Q1 2020 was €5.1 million, a decrease from €11.4 million in Q1 2019, mainly due to reduced revenue from the Genentech collaboration [44]. Business Line Data and Key Metrics Changes - R&D expenses for Q1 2020 were €11.4 million, up from €8 million in Q1 2019, attributed to higher costs related to the AFM13 registration-directed study and manufacturing activities [45]. - G&A expenses increased to €3.5 million in Q1 2020 from €2.4 million in Q1 2019, primarily due to higher personnel and compliance costs [46]. Market Data and Key Metrics Changes - The company is focusing on the development of innate cell engagers targeting various oncology indications, with AFM13 and AFM24 in clinical development and AFM28 and AFM32 in preclinical stages [12][35]. Company Strategy and Development Direction - The company aims to leverage its ROCK platform to develop novel therapies that utilize the innate immune system to treat cancer, addressing patients with limited treatment options [9][10]. - The management team has been strengthened with key industry leaders to enhance execution of the company's strategy [11][12]. Management's Comments on Operating Environment and Future Outlook - The management acknowledged the challenges posed by COVID-19 but expressed optimism about ongoing clinical trials and patient recruitment [36][37]. - The company anticipates that its cash position will support operations well into the first half of 2022, allowing for continued development of its clinical programs [44]. Other Important Information - The company has initiated clinical trials for AFM24 and is actively recruiting patients for the second dose cohort [47]. - The collaboration with Genentech on the anti-BCMA innate cell engager is progressing, with a Phase I study expected to start soon [34][47]. Q&A Session Summary Question: AFM13 timelines for the registrational program - Management anticipates interim data around mid-2021, despite challenges from COVID-19 [51]. Question: Details on AFM13 plus NK cell combo study - The commercial product format is still under evaluation, and it is too early to determine whether it will be a premix or co-administration [54]. Question: Safety and efficacy in cohort 1 of AFM24 - No dose-limiting toxicities were observed, and pharmacodynamic markers are being collected for analysis [56]. Question: Details on the first two patients in cohort 1 - The patients had non-small cell lung cancer and colorectal cancer, but specific KRAS mutation status has not been disclosed yet [60]. Question: Pre and post-treatment biopsies for NK cell recruitment - The protocol allows for optional biopsies, which will be collected on a voluntary basis [62]. Question: Update on BCMA engager with Genentech - The Phase 1 study is expected to start around July, with recruitment details available on clinicaltrials.gov [69]. Question: Data update for AFM24 - It is too early to provide a specific timeline for data updates, as it depends on the number of dose escalation steps needed [72]. Question: Emerging pipeline with AFM28 and AFM32 - The company targets an IND filing for AFM28 by the end of 2021, while AFM32 is further behind in development [80].
Affimed(AFMD) - 2019 Q4 - Earnings Call Transcript
2020-04-29 02:00
Affimed N.V. (NASDAQ:AFMD) Q4 2019 Earnings Conference Call April 28, 2019 8:30 AM ET Company Participants Greg Gin - Investor Relations Adi Hoess - Chief Executive Officer Andreas Harstrick - Chief Medical Officer Michael Wolf - Head of Finance Arndt Schottelius - Chief Scientific Officer Wolfgang Fischer - Chief Operating Officer Denise Mueller - Chief Business Officer Conference Call Participants Jay Birchenough - Wells Fargo I-Eh Jen - Laidlaw & Company Dilip Joseph - SVB Leerink Operator Good day, and ...
Affimed(AFMD) - 2019 Q4 - Annual Report
2020-04-28 21:02
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, 2019. 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 S ...