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]

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 ...

selvanegra Introduction I am going to touch on key highlights from my article on Affimed NV (NASDAQ:AFMD) on 06/11/24 and additional updates from the company given a day later in their 1Q '24 Financial Results & Business Update. Therefore, I highly recommend readers review my first article, Affimed: AFM24's Update Was Good, Acimtamig's Should Be Better if they have not already. The focus of this article will be on the 3 key assets AFMD has in the clinic (AFM24, acimtamig and AFM28). I will also briefly touc ...

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 ...

MANNHEIM, Germany, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that Shawn M. Leland, PharmD, RPh has been appointed as Chief Executive Officer (CEO). Dr. Andreas Harstrick, who has been serving as acting CEO since January 2024 will continue in his position as Chief Medical Officer (CMO). Shawn is an accomplished pharmaceutical and b ...

MANNHEIM, Germany, Aug. 29, 2024 (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 will release second quarter 2024 results and corporate update on Thursday, September 5, 2024. The Company will host a conference call at 8:30 a.m. EDT / 14:30 CET. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcast ...