Financial Data and Key Metrics Changes - The company ended Q3 2024 with cash, cash equivalents, and investments of €24.1 million, down from €72 million on December 31, 2023 [23] - Total revenue for Q3 2024 was €0.2 million, compared to €2.0 million in Q3 2023 [24] - R&D expenses for Q3 2024 were €10.1 million, down from €21.5 million in the same quarter of 2023 [24] - General and administrative expenses for Q3 2024 were €4.3 million, compared to €5.4 million in Q3 2023 [25] - The net loss for Q3 2024 was €15.1 million, or €0.94 loss per share, compared to a net loss of €24.4 million, or €1.63 loss per share, in Q3 2023 [25] Business Line Data and Key Metrics Changes - The AFM24 program is progressing well, with both EGFR wild-type and mutant cohorts fully enrolled and actively treating patients [17] - The AFM28 program has shown promising monotherapy results, with no dose-limiting toxicities observed at the 300 mg weekly dose level [20] Market Data and Key Metrics Changes - The company is focusing on treatment-refractory non-small cell lung cancer patients, with a median progression-free survival of 5.9 months reported for the EGFR wild-type cohort [18] - The company is also targeting patients with relapsed refractory acute myeloid leukemia (AML) with its AFM28 program, which is expected to provide a chemotherapy-free alternative for patients who have failed multiple lines of treatment [19] Company Strategy and Development Direction - The company aims to deliver therapies that demonstrate strong clinical efficacy and have a meaningful impact on treatment paradigms while being commercially sustainable [13] - The management is pursuing a wider range of potential collaborations to broaden strategic options and engage with a diverse set of partners [13] - The company is committed to improving its financial health and ensuring it is well-capitalized to support clinical development [14] Management's Comments on Operating Environment and Future Outlook - The management expressed confidence in the company's ability to navigate the challenging market environment and secure necessary capital for progress [25] - The management highlighted the importance of partnerships in accelerating progress and emphasized the need for differentiated clinical data from ongoing trials [14][15] Other Important Information - The company plans to present key clinical updates at the ASH 2024 conference, including data from the AFM28 and AFM24 programs [11][12] - A dedicated conference call for AFM24 updates is scheduled for December 17, 2024 [12] Q&A Session Summary Question: Durability expectations for AFM28 data at ASH - Management indicated that six patients reported at the last earnings call will have a meaningful observation period to assess durability of responses, while additional patients may not have sufficient follow-up for meaningful conclusions [26][27] Question: Registration path for AFM28 - Management stated that they are planning to add higher-dose cohorts to capture full therapeutic potential and will consider going to the FDA based on data maturation [28][30] Question: Broadened collaboration strategy - Management clarified that they are evaluating a variety of strategic partnerships, including regional deals, to create additional optionality for non-dilutive capital [32][33] Question: Development path for AFM24 - Management noted that they are waiting for data maturity from the AFM24 program and considering various combinations for future trials [34][35] Question: Data expectations for AFM24 in December - Management confirmed that the focus will be on response rates in December, with mature PFS data expected in the first half of 2025 [37][41] Question: Partnership discussions for AFM24 - Management is open to discussing partnerships for all innate cell engager programs and is looking for more mature data to gain confidence from potential partners [65]

Clinical Program Updates - AFM24 (ICE® in EGFR+ Solid Tumors): In EGFRwt1 patients, 4 out of 17 showed confirmed responses, with a PFS of 5.9 months; 3 of the 4 responses are ongoing at >7 months[6] - AFM24 (ICE® in EGFR+ Solid Tumors): In EGFRmut2 patients, 4 out of 17 showed confirmed responses; 8 out of 17 patients continue on treatment with 4 out of 4 responders on treatment for at least 7 months[6] - Acimtamig (ICE® for CD30+ Lymphomas): An ORR of 83.3% (10/12) was observed in r/r HL patients, including 6 CRs (50%)[7] - AFM28 (ICE® in AML): 4 out of 12 patients achieved CR/CRi at doses of 250mg and 300mg[9] - AFM28 (ICE® in AML): At DL6, CRc of 50% (3/6) was achieved, leading to the completion of recruitment of an additional 6 patients at DL6[9] Financial Status - Total cash, cash equivalents, and investments as of September 30, 2024, were €24.1 million, compared to €72.0 million as of December 31, 2023[10] - Net cash used in operating activities for the quarter ended September 30, 2024, was €(11.1) million, compared to €(18.3) million for the quarter ended September 30, 2023[11] - Revenue for the quarter ended September 30, 2024, was €0.2 million, compared to €2.0 million for the quarter ended September 30, 2023[12] - Research and development expense for the quarter ended September 30, 2024, was €(10.1) million, compared to €(21.5) million for the quarter ended September 30, 2023[12] - Operating loss for the quarter ended September 30, 2024, was €(14.3) million, compared to €(24.9) million for the quarter ended September 30, 2023[12]

Core Insights - Affimed N.V. reported financial results and clinical updates for Q3 2024, highlighting progress in its immuno-oncology pipeline and financial position [2][3]. Clinical Updates - The AFM24 trial for non-small cell lung cancer (NSCLC) EGFR wild-type cohort has completed enrollment, with objective response rate (ORR) and safety data to be presented on December 17, 2024. Previous data showed a 71% disease control rate among patients who failed chemotherapy and PD-1/PD-L1 treatment [4][7]. - Updated clinical data for Acimtamig (AFM13) in combination with AlloNK® will be presented at ASH 2024, with a reported ORR of 83.3% and a complete response rate (CRR) of 50% in advanced Hodgkin Lymphoma patients [5][7]. - The AFM28 monotherapy phase 1 dose-escalation study will present updated clinical data at ASH 2024, with initial results showing a composite complete remission (CRc) rate of 50% in relapsed/refractory acute myeloid leukemia (AML) patients [6][7]. Financial Highlights - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments totaling €24.1 million, projected to last into Q4 2025 based on current operating plans [9][10]. - Total revenue for Q3 2024 was €0.2 million, a significant decrease from €2.0 million in Q3 2023, primarily due to the completion of prior collaborations [11]. - Research and development expenses decreased to €10.1 million in Q3 2024 from €21.5 million in the same quarter of 2023, attributed to reduced clinical trial costs and restructuring [12]. - The net loss for Q3 2024 was €15.1 million, or €0.94 loss per share, compared to a net loss of €24.4 million, or €1.63 loss per share, in Q3 2023 [14].

Core Insights - Affimed N.V. will release its third quarter 2024 results and corporate update on November 14, 2024 [1] - A conference call will be held at 8:30 a.m. EST / 14:30 CET to discuss the results [1] - The conference call will be accessible via phone and webcast, with a replay available for 30 days [2][3] Company Overview - Affimed N.V. is a clinical-stage immuno-oncology company focused on enhancing patients' innate ability to combat cancer [4] - The company utilizes its proprietary ROCK® platform to develop innate cell engagers (ICE®) that target and kill various tumors [4] - Affimed is headquartered in Mannheim, Germany, and is led by a team of experienced biotechnology and pharmaceutical professionals [4] Investor Relations - The Director and Head of Investor Relations is Alexander Fudukidis, who can be contacted via email or phone for inquiries [5]

Financial Data and Key Metrics Changes - The company ended Q2 2024 with cash, cash equivalents, and investments of €34.4 million, down from €72 million at the end of 2023 [24] - Net cash used in operating activities for Q2 2024 was €16.5 million, compared to €33.3 million in Q2 2023 [25] - Total revenue for Q2 2024 was €0.2 million, a decrease from €1.4 million in Q2 2023 [25] - R&D expenses for Q2 2024 were €11.7 million, down from €25.3 million in 2023 [25] - G&A expenses for Q2 2024 were €4 million, compared to €6.3 million in Q2 2023 [25] - The net loss for Q2 2024 was €15.5 million, or €1.01 per share, compared to a net loss of €29.4 million, or €1.97 per share, in Q2 2023 [25] Business Line Data and Key Metrics Changes - The AFM24-102 trial for non-small cell lung cancer is nearing full enrollment, with early efficacy data showing a 23.5% objective response rate and a 70.6% disease control rate in the EGFR mutant cohort [16][17] - The acimtamig (AFM13) program in multi-refractory Hodgkin's lymphoma shows an 83.3% response rate, with 50% achieving complete response [19] - The AFM28 program for acute myeloid leukemia has shown a 50% complete response rate at the highest dose level, indicating a potential dose-response relationship [22] Market Data and Key Metrics Changes - The company sees over 14,000 patients per year in the seven major markets who fail at least two lines of standard therapy for acute myeloid leukemia, indicating a significant unmet medical need [23] Company Strategy and Development Direction - The new CEO emphasizes the importance of securing funding to support clinical programs and expanding partnerships with pharmaceutical companies [9][10] - The company aims to achieve operational efficiency and continuous improvement to deliver value to stakeholders [10] - There is a focus on exploring innovative partnerships to enhance clinical development and patient access to therapies [10] Management's Comments on Operating Environment and Future Outlook - The management acknowledges the challenging capital markets for biotechs in 2024 but expresses confidence in the company's compelling clinical data [9] - The CEO is committed to increasing shareholder value through successful execution of clinical programs and forging new partnerships [29] Other Important Information - The company plans to disclose data from all four cohorts of the acimtamig study at a scientific meeting in Q4 2024 [20] - The company anticipates that cash and equivalents will finance operations into the second half of 2025 [24] Q&A Session Summary Question: Differences in AFM24 data among patients with prior TKIs - Management confirmed no observed differences in response rates between patients who had prior third-generation TKIs and those with first- or second-generation TKIs [33] Question: Expectations for higher NK cell dose in LuminICE study - Management indicated no differences in response rates between the 200 mg and 300 mg doses so far, with further data expected in Q4 2024 [36] Question: Development strategy for AFM28 and AFM24 - Management highlighted the encouraging monotherapy activity of AFM28 and the potential for combination therapies, emphasizing a data-driven approach for future development [42][45] Question: Durability of response threshold for AML - Management stated that a meaningful response would be a progression-free survival of around six months in heavily pretreated patients [49] Question: Mutations in AML patients treated with AFM28 - Management noted that the mutation patterns observed are representative of a pretreated AML population, with detailed data to be released in Q4 [53] Question: Enrollment progress for cohorts 3 and 4 - Management expressed satisfaction with enrollment progress, attributing it to improved site training and increased site participation [60]

HARNESSING THE POTENTIAL OF THE INNATE IMMUNE SYSTEM FOR ONCOLOGY NASDAQ: AFMD Q2 2024 Business & Financial Update 2 Forward-Looking Statements This presentation and the accompanying oral commentary contain "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation and the accompanying oral commentary, including statements regarding our future financial condition, business strategy and plans and objec ...

AFM24 combination with atezolizumab: 24 patients treated in the EGFR mutant (EGFRmut) non-small cell lung cancer (NSCLC) cohort; in 17 response-evaluable patients: 1 complete response (CR), 3 partial responses (PRs) and 8 stable diseases (SDs) were reported. Objective response rate (ORR) is 23.5% (4/17) and disease control rate (DCR) is 70.6% (12/17). Median follow-up of > 7 months, 8 of 17 patients continue on treatment.The EGFR wild type (EGFRwt) cohort of treatment refractory NSCLC patients has treated 4 ...

Core Insights - The article discusses the recent updates and financial results of Affimed NV (NASDAQ:AFMD), focusing on its key assets in clinical development: AFM24, acimtamig, and AFM28 [2][4][5] - The upcoming updates on these assets are anticipated to significantly impact the company's valuation, which is currently around $60 million [4][19] - The company is expected to provide updates on acimtamig and AFM24 in the near future, with potential for increased asset value based on positive clinical data [4][16] Financial Overview - As of the latest report, the company has approximately $52.4 million in cash and a burn rate of about $21.58 million, indicating a potential need for capital raising within the next 6-12 months [4][15] - The company is projected to have enough cash to last through the first half of 2025, contingent on achieving certain milestones [15] Asset Analysis - **AFM24**: Early results in NSCLC show promising outcomes, with 4 of 17 patients responding positively in the wildtype cohort and 4 of 13 in the mutant cohort. Upcoming updates on a larger patient group could be pivotal [6][8] - **Acimtamig**: The recent update indicated an overall response rate (ORR) of 85.7% in a small cohort for r/r Hodgkin Lymphoma, with expectations for improved results as more data becomes available [9][10] - **AFM28**: Initial results show a 33% ORR in a small cohort of r/r AML patients, suggesting potential for further development and partnership opportunities [11][13] Strategic Considerations - The company is exploring potential collaborations, particularly for AFM28, which could enhance its market position and financial stability [15][19] - The upcoming ASH meeting in December is expected to provide further insights into the clinical progress of acimtamig and AFM28, which could influence investor sentiment and stock valuation [4][19] Market Potential - The potential market for AFM24 in NSCLC is substantial, with estimates suggesting a multi-billion-dollar revenue opportunity if it proves to be a viable treatment option [16][17] - Acimtamig's peak sales potential is projected to be between $500 million to $1 billion, depending on clinical outcomes and market conditions [16][17] Leadership Changes - The recent appointment of a new CEO is expected to bring changes to the company's strategic direction, which may influence investor confidence and stock performance [19]

Affimed N.V. (AFMD) announced that it has appointed Shawn M. Leland as the company’s new chief executive officer (CEO). Shares of the company were down 6.6% on Sep 3 following the announcement of the news.Leland will replace Andreas Harstrick who has been the acting CEO of Affimed since January 2024. The latter will continue in his role as the chief medical officer.Leland most recently served as the interim CEO and board director of ForeBio. Previously, he held various senior leadership positions at Veraste ...

Core Viewpoint - Affimed N.V. has appointed Shawn M. Leland as the new Chief Executive Officer, succeeding Dr. Andreas Harstrick, who will remain as Chief Medical Officer. This leadership change is expected to drive the company's growth and corporate development strategy in the immuno-oncology sector [1][4]. Company Overview - Affimed is a clinical-stage immuno-oncology company focused on leveraging the innate immune system to combat cancer. The company has three active clinical programs that have demonstrated clinical proof of concept [4]. Leadership Background - Shawn M. Leland brings over 15 years of experience in the pharmaceutical and biotechnology industries, with a strong track record in advancing oncology assets and raising significant capital. His previous roles include Interim CEO at ForeBio and CEO of Elevation Oncology, where he raised over $200 million, including a $100 million IPO [2][3]. Strategic Vision - Leland expressed enthusiasm about leading Affimed, emphasizing the importance of the company's pipeline and the need for novel therapies to reach underserved patients. He aims to create value for shareholders by navigating the company through critical inflection points [4]. Transition Acknowledgment - The Chairman of Affimed's Supervisory Board, Dr. Thomas Hecht, acknowledged Dr. Harstrick's contributions as acting CEO, highlighting the company's strong position and readiness for future clinical developments [4].