MANNHEIM, Germany, April 21, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it has received a written notice (the “Notice”), dated April 15, 2025, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty (30) consecutive business days, the bid price for the Company’s common shares had closed below the min ...

Core Insights - Affimed N.V. announced that an abstract on AFM24 dose optimization has been accepted for presentation at the AACR Annual Meeting 2025 [1][2] Group 1: Presentation Details - The title of the poster presentation is "Dose-Optimization Using Exposure Response Analysis in AFM24 (in Monotherapy and with Atezolizumab) in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer" [2] - The presentation will take place on April 29, 2025, from 9:00 AM to 12:00 PM CDT [2] - The published abstract number is CT161, and it will be available online on April 25, 2025 [3] Group 2: About AFM24 - AFM24 is a tetravalent, bispecific ICE® that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR) [4] - The mechanism of action for AFM24 involves engaging innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis [4] Group 3: About Affimed N.V. - Affimed is a clinical-stage immuno-oncology company focused on harnessing the innate immune system to fight cancer [5] - The company's innate cell engagers (ICE®) are designed to target and kill a variety of hematologic and solid tumors [5] - Affimed is headquartered in Mannheim, Germany, and is led by a team of biotechnology and pharmaceutical leaders [5]

Core Viewpoint - Affimed N.V. is actively participating in the Leerink Partners Global Healthcare Conference 2025, highlighting its commitment to advancing immuno-oncology and engaging with investors [1][2]. Company Overview - Affimed N.V. is a clinical-stage immuno-oncology company focused on empowering patients to combat cancer by harnessing the innate immune system [3]. - The company develops innate cell engagers (ICE) that target and eliminate various hematologic and solid tumors, utilizing its proprietary ROCK platform to create customized molecules [3]. - Affimed is headquartered in Mannheim, Germany, and is led by a team of experienced biotechnology and pharmaceutical professionals dedicated to innovative cancer treatments [3]. Event Details - The CEO, Dr. Shawn Leland, will participate in a fireside chat at the conference on March 11, 2025, at 2:20 p.m. Eastern Daylight Time [1]. - A live webcast of the presentation will be available on Affimed's website, with a replay accessible for 30 days post-event [2].

Core Insights - The combination of AFM24 and atezolizumab shows promising clinical activity in heavily pretreated NSCLC patients, with an overall response rate (ORR) of 21% in EGFR wild-type patients and 24% in EGFR mutant patients, alongside a disease control rate (DCR) of 76% and 71% respectively [1][7][10] - A post-hoc analysis indicates that higher exposure to AFM24 correlates with significantly improved response rates and progression-free survival (PFS), leading to a planned increase in dosage to 720 mg weekly for future development [1][9][10] NSCLC EGFR Wild-type Cohort Update - The patient population included 43 patients in the full analysis set, with 33 in the per protocol set, having a median of 2 prior lines of therapy [3] - The combination therapy resulted in an ORR of 21%, with tumor shrinkage observed in 48% of patients and a preliminary median PFS of 5.6 months [5] NSCLC EGFR Mutant Cohort Update - The cohort consisted of 28 patients in the full analysis set, with 17 patients in the per protocol set, all having received prior EGFR-specific TKI therapy [6] - The combination therapy achieved an ORR of 24%, with tumor shrinkage in 41% of patients and a median PFS of 5.6 months [7] Safety Profile - The combination therapy was well tolerated, with infusion-related reactions being the most common adverse event reported in 54% of patients, and no unexpected safety findings were identified [4][10] Post-Hoc Exposure-Response Analysis - The analysis included 44 patients treated with 480 mg AFM24, revealing that the high exposure group had an ORR of 46% and a median PFS of 7.4 months, indicating a clear relationship between exposure and efficacy [8][9] Company Overview - Affimed N.V. is a clinical-stage immuno-oncology company focused on harnessing the innate immune system to combat cancer, with its proprietary ROCK® platform generating innovative innate cell engagers (ICE®) for targeted tumor therapy [11][12]

Core Insights - The U.S. FDA has granted RMAT designation to Affimed's combination therapy of acimtamig and Artiva's AlloNK for treating relapsed or refractory Hodgkin Lymphoma, based on early efficacy data showing an 83.3% overall response rate and a 50% complete response rate [1][3][2] Group 1: Regulatory Milestone - RMAT designation aims to expedite the development and review of regenerative medicine therapies, providing benefits similar to Breakthrough Therapy Designation, specifically for regenerative medicine products [2] - This designation allows Affimed enhanced access to FDA resources, potentially leading to accelerated approval and priority review, which could significantly reduce the time to market for the combination therapy [2] Group 2: Clinical Data and Efficacy - Early efficacy data from the LuminICE-203 trial indicated an overall response rate of 83.3% (10 out of 12 patients) and a complete response rate of 50% (6 out of 12 patients), with a well-managed safety profile [1][3] - Data from all cohorts of the LuminICE-203 trial will be presented at the 66th ASH Annual Meeting on December 8, 2024 [3] Group 3: Broader Applications - The combination therapy has potential applicability in other CD30 positive lymphomas, such as peripheral T-cell lymphoma, which is resistant to conventional therapies and has a high risk of relapse [4] - Establishing clinical proof-of-concept in peripheral T-cell lymphoma could enhance the commercial potential of the combination therapy significantly [4] Group 4: Product Information - Acimtamig (AFM13) is a first-in-class innate cell engager designed to activate the innate immune system to target and destroy CD30-positive hematologic tumors [5] - The LuminICE-203 trial is a Phase 2 open-label, multicenter, multi-cohort study evaluating the safety and efficacy of acimtamig in combination with Artiva's AlloNK in patients with relapsed/refractory classical Hodgkin lymphoma and CD30-positive peripheral T-cell lymphoma [6]

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]

HARNESSING THE POTENTIAL OF THE INNATE IMMUNE SYSTEM FOR ONCOLOGY NASDAQ: AFMD Q3 2024 Business & Financial Update Forward-Looking Statements 2 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 ...

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]