Affimed N.V. · OTC:AFMDQ
Affimed — Q2 2024 Earnings Presentation
20 slides from Affimed's earnings presentation, Sep 5, 2024
Slide 1: Harnessing the Potential of the Innate Immune System for Oncology
HARNESSING THE POTENTIAL OF THE INNATE IMMUNE SYSTEM FOR ONCOLOGY NASDAQ: AFMD Q2 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: AFM24: ICE in EGFR+ Solid Tumors
AFM24 ICE® in EGFR+ Solid Tumors Update: NSCLC EGFR mutant
Slide 4: AFM24 + Atezolizumab NSCLC EGFRmut Expansion Cohort - Patient Disposition
AFM24 + Atezolizumab NSCLC EGFRmut Expansion Cohort - Patient Disposition - Recruitment Ongoing Patients Disposition N Patients in the FAS1 24 Patients with no valid scan (yet) 7 • Reasons: • 4 early discontinuations/deteriorations • 1 discontinuation without scan • 2 ongoing with no scan yet Patien
Slide 5: AFM24 + Atezolizumab NSCLC EGFRmut Expansion Cohort - Patient Characteristics
AFM24 + Atezolizumab NSCLC EGFRmut Expansion Cohort - Patient Characteristics Patient Characteristics N = 17 (PPS) NSCLC EGFRmut cohort Age (years) Median-Range 67 (32-76) Sex (n (%)) • Male 3 (17.6%) • Female 14 (82.4%) Race (n (%)) • White 5 (29.4%) • Asian 12 (70.6%) ECOG PS (n (%)) • 0 1 (5.9%)
Slide 6: AFM24 + Atezolizumab NSCLC EGFRmut Expansion Cohort - Clinical Activity
AFM24 + Atezolizumab NSCLC EGFRmut Expansion Cohort - Clinical Activity Activity N = 17 PPS NSCLC EGFRmut cohort ORR 4/17 (23.5%) SD 8/17 (47.0%) DCR 12/17 (70.6%) • Median follow up is 7 months • 8/17 patients continue on treatment • 4/4 responders on treatment for at least 7 months ORR= Objective
Slide 7: Acimtamig: ICE for CD30+ Lymphomas
Acimtamig ICE® for CD30+ Lymphomas
Slide 8: LuminICE-203 Study Design: Aligned with FDA Feedback
LuminICE-203 Study Design: Aligned with FDA Feedback To Support Potential Accelerated Approval; Fast Track Designation Granted PHASE 2 TRIAL, R/R HODGKIN LYMPHOMA (SIMON TWO-STAGE DESIGN)/NCT: 05883449 Cohort 1, DL1* NK cell dose, R/R HL: SIMON TWO-STAGE DESIGN Run-in N=6 pts 200 mg acimtamig (HL) C
Slide 9: LuminICE-203: R/R Hodgkin Lymphoma Patient Baseline Characteristics
LuminICE-203: Relapsed/Refractory Hodgkin Lymphoma Patient Baseline Characteristics in Safety Run-In (Cohorts 1 and 2) with High Unmet Need Baseline Characteristics N=12 Age, median (range) 42.5 (23–80) Gender (male/female) 9/3 ECOG 0 / ECOG 1 2 / 10 Diagnosis (classical Hodgkin Lymphoma) 100% Clini
Slide 10: LuminICE-203: Best Objective Response Rate Cohort 1 and 2
LuminICE-203: Best Objective Response Rate Cohort 1 and 2 (Central Review) Efficacy Total (N=12) (per Lugano Criteria) N (%) ORR Best Response 83.3% CRR CR 6 (50.0%) n = 12 50.0% PR* 4 (33.3%) PD 2 (16.7%) ORR 10 (83.3%) LuminICE-203: Acimtamig+AlloNK * 3 PR on treatment with option to deepen respon
Slide 11: LuminICE-203: Status and Further Milestones
LuminICE-203: Status and Further Milestones Current Status for relapsed /refractory Hodgkin Lymphoma cohorts1-4 Cohort 1 and 2 200mg or 300mg acimtamig weekly with low AlloNK® cell dose (2x109 NK cells) Fully enrolled (12/12 patients) Efficacy evaluation for 12 patients with Objective Response
Slide 12: AFM28: ICE in AML
AFM28 ICE® in AML @nereimeD
Slide 13: AFM28-101: Status Update - Target Engagement at 200 mg and Above
AFM28-101: Status Update - Desired Target Engagement at Doses Levels of 200 mg and Above for Relapsed /Refractory Acute Myeloid Leukemia Recent Progress for AFM28-101 Dose Level 6 300 mg (n=6) Predicted Predicted Dose Escalation of CD123 bispecific ICE® in r/rAML Efficacious Efficacious Dose Level 5
Slide 14: AFM28-101: Phase 1 Mono Trial Shows Promising Clinical Signals in R/R AML
AFM28-101: Phase 1 Mono trial of CD123 Bispecific Innate Cell Engager Shows Promising Clinical Signals in relapsed/refractory Acute Myeloid Leukemia AFM28 mono data in AFM28-101 confirms early signs of efficacy in r/r AML patients to validate further development in combination Dose level 5 Dose leve
Slide 15: 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 16: Michael Wolf, Vice President, Finance
Michael Wolf Vice President, Finance
Slide 17: Selected Balance Sheet and Cash Flow Metrics
Selected Balance Sheet and Cash Flow Metrics Balance Sheet As of As of June 30, 2024 December 31, 2023 (millions of €) (millions of €) Total Cash, Cash Equivalents & Investments 34.4 72.0 Cash Flow For the quarter ended For the quarter ended June 30, 2024 June 30, 2023 (millions of €) (millions of €
Slide 18: Selected Income Statement Metrics
Selected Income Statement Metrics For the quarter ended For the quarter ended June 30, 2024 June 30, 2023 (millions of €) (millions of €) Revenue 0.2 1.4 Other Income and expenses – net 0.1 0.7 Research and development expense (11.7) (25.3) General and administrative expense (4.0) (6.3) Operating lo
Slide 19: 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 20: Thank you!
Thank you!