Slide 1: Harnessing the Potential of the Innate Immune System for Oncology
HARNESSING THE POTENTIAL OF THE INNATE IMMUNE SYSTEM FOR ONCOLOGY NASDAQ: AFMD Q1 2024 Business & Financial Update
Slide 2: Forward-Looking Statements
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, inclu
Slide 3: All Programs Have Demonstrated Clinical Efficacy Validating Affimed's Approach
All 3 Programs Have Demonstrated Clinical Efficacy Validating Affimed's Approach to Leverage the Innate Immune System to Fight Cancer AFM24 development is focused AFM28 development is focused on Acimtamig (AFM13) + NK cells is CD123 r/r AML where strong preclinical data EGFR on advanced EGFR+ NSCLC
Slide 4: Acimtamig
Acimtamig ICE® for CD30+ Lymphomas
Slide 5: LuminICE-203 Study Design: Aligned with FDA Feedback; Fast Track Granted
LuminICE-203 Study Design: Aligned with FDA Feedback To Support Potential Accelerated Approval; Fast Track Designation Granted PHASE 2 TRIAL, R/R HL (SIMON TWO-STAGE DESIGN) Cohort 1, DL1* NK cell dose, Simon Two-Stage Design Study (68 to 110 patients) Run-in N=6 pts 200 mg acimtamig (cHL) Cohort 2,
Slide 6: LuminICE-203: Well Managed Safety Profile of Acimtamig and AlloNK
LuminICE-203: Well Managed Safety Profile of Acimtamig and AlloNK ® Well manageable safety profile observed with acimtamig and AlloNK® in LuminICE-2031 Safety profile consistent with data reported for study AFM13-104 (MDACC)2 • Grade 1 or 2 IRR/CRS in 4/7 patients; 1 short lasting Grade 3 CRS in a p
Slide 7: LuminICE-203: Potential to Address a High Unmet Need in R/R Patient Population
LuminICE-203: Potential to Address a High Unmet Need in an Increasing R/R Patient Population of CD30+ Lymphomas Early data confirms previously reported efficacy and validates co-administration approach of acimtamig with an off-the-shelf, ORR 85.7% allogeneic, cryopreserved, NK cell product in r/r HL
Slide 8: Acimtamig + AlloNK Cells Hold Promise for HL Patients Who Relapse or are Refractory
Acimtamig + AlloNK® Cells Hold Promise for HL Patients Who Relapse or are Refractory to BV & CPI Treatment Driving Future Clinical Development AFM13-203 Treatment History (Acimtamig+ AlloNK® cell combo) N=7 Age, median (range) 42 (23–66) Gender (male/female) 5/2 ECOG 0 / ECOG 1 2/5 Diagnosis (classi
Slide 9: LuminICE-203 Case Study
LuminICE-203 Case Study Patient with Relapsed and Refractory Hodgkin Lymphoma in Complete Remission after first cycle in LuminICE-203 - Patient with R/R cHL Patient Background & LuminICE-203: Treatment with 300 mg AFM13 and 2x109 AB-101 Treatment History (Cohort 2) Baseline Assessment after first cy
Slide 10: AFM24
AFM24 ICE® in EGFR+ Solid Tumors
Slide 11: AFM24-102 NSCLC EGFRwt Expansion Cohort Demonstrates Efficacy Competitive with 2L Therapies
AFM24-102 NSCLC EGFRwt Expansion Cohort Demonstrates Compelling Efficacy that is Competitive with Current 2L Therapies Best Percent Change From Baseline Efficacy Highlights and Considerations • Tumor shrinkage in 8 (47%) patients (n=172) • 71% disease control rate • 4 objective responses, 8 stable d
Slide 12: AFM24 and Atezolizumab Induce Durable Responses in Heavily Pretreated EGFRwt NSCLC
AFM24 and Atezolizumab Induce Durable Responses in Heavily Pretreated EGFRwt NSCLC Patients (3 of 4 Responses Ongoing at > 7 Month) 1 2 Median FU: 7.4 months 3 4 Median PFS: 5.9 months Ordered by treatment duration 5 6 7 8 9 10 11 12 à Indicates treatment ongoing 13 14 15 16 17 According to RECIST 1
Slide 13: AFM24 Combination with Atezolizumab Induces Responses in EGFRmut NSCLC Patients
AFM24 Combination with Atezolizumab Induces Objective Responses and Tumor Control In Treatment Refractory EGFRmut NSCLC Patients Best Percent Change From Baseline Patients Recruited and Treated N=21 7 patients not evaluable by • 4 early PD RECIST 1.1 and thus not • 2 clinical PD included in the WF p
Slide 14: AFM24 Has Potential to be the First Innate Cell Engager to Show Clinical Benefit
AFM24 Has Potential to be the First Innate Cell Engager to Show Clinical Benefit with a Manageable Safety Profile in Solid Tumors; Data Updates Expected Q3 & Q4 2024 NSCLC is a Highly Aggressive Tumor and Current AFM24 + CPI Has the Potential to Address Options After First-Line Therapy are Limited S
Slide 15: AFM28
AFM28 ICE® in AML @nereimeD
Slide 16: AFM28-101: Status Update - Target Engagement at Dose Levels of 200 mg and Above
AFM28-101: Status Update - Desired Target Engagement at Doses Levels of 200 mg and Above for R/R Acute Myeloid Leukemia (AML) Recent Progress for AFM28-101 Dose Level 6 300 mg (n=6) Predicted Predicted Dose Escalation of CD123 bispecific ICE® in r/r AML Efficacious Efficacious Dose Level 5 Doses: Do
Slide 17: AFM28-101: CD123 Bispecific Innate Cell Engager Shows Promising Clinical Signals in AML
AFM28-101: Phase 1 Mono trial of CD123 Bispecific Innate Cell Engager Shows Promising Clinical Signals in Treatment Refractory Acute Myeloid Leukemia AFM28 mono data in AFM28-101 confirms early signs of efficacy in treatment refractory AML patients to validate further 85.7% development in combinatio
Slide 18: 60% of AML Patients are Primary Refractory or Relapse Within 1 Year
60% of AML Patients are Primary Refractory or Relapse Within 1 Year of Initial Treatment, New Safer and Effective Options Are Needed AML is Characterized by High Unmet Need There is a Lack of Safe and Effective and a Significant Addressable Population Treatments Options for R/R AML Patients • Low ov
Slide 19: Michael Wolf, Vice President, Finance
Michael Wolf Vice President, Finance
Slide 20: Selected Balance Sheet and Cash Flow Metrics
Selected Balance Sheet and Cash Flow Metrics Balance Sheet As of As of March 31, 2024 December 31, 2023 (millions of €) (millions of €) Total Cash, Cash Equivalents & Investments 48.5 72.0 Cash Flow For the quarter ended For the quarter ended March 31, 2024 March 31, 2023 (millions of €) (millions o
Slide 21: Selected Income Statement Metrics
Selected Income Statement Metrics For the quarter ended For the quarter ended March 31, 2024 March 31, 2023 (millions of €) (millions of €) Revenue 0.2 4.5 Other Income and expenses – net 0.2 0.4 R&D (15.4) (29.5) General and administrative expense (4.5) (6.9) Operating loss (19.5) (31.5) Loss for t
Slide 22: Three Ongoing Studies with ICE Confirm the Potential of the Innate Immune System
Three Ongoing Studies with ICE® Confirm the Potential of the Innate Immune System in Fighting Cancer Progressed clinical programs to pivotal data readouts • All three assets advanced in the clinic showing promise in relapsed/refractory patients Realized clinical proof of concept for all three ICE® i
Slide 23: Thank you!
Thank you!