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AFM24 UPDATE December 17, 2024
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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 objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other similar expressions.Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of acimtamig (AFM13), AFM24, AFM28 and our other product candidates; the value of our ROCK® platform; our ongoing and planned clinical trials; our corporate restructuring, the associated headcount reduction and the impact this may have on our anticipated savings and total costs and expenses; our ability to raise equity capital from the sale of shares if we do not receive shareholder approval at our annual meeting on June 26, 2024 to renew the authorizations of the management board to issue shares and to restrict and/or exclude pre-emptive rights, our collaborations and development of our products in combination with other therapies; the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; our collaboration activities; our ability to develop commercial functions; clinical trial data; our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which we operates; the macroeconomic trends that may affect the industry or us, such as the instability in the banking sector experienced in the first quarter of 2023; impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation; the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; the fact that the current clinical data of acimtamig in combination with NK cell therapy is based on acimtamig precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AlloNK® (also known as AB-101); and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission (the “SEC”). Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our management’s beliefs and assumptions only as of the date of this presentation. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.The information contained in this presentation is solely for the purpose of familiarizing recipients hereof with Affimed and should be considered in the context of Affimed’s SEC filings (including our effective registration statement and related prospectus, Form 20-F and other documents Affimed has filed with the SEC) and other public announcements that Affimed may make, by press release or otherwise from time to time. You should read these filings for more complete information about Affimed. You may get these filings for free by visiting EDGAR or the SEC website at www.sec.gov. This presentation and information contained herein should not be construed as a solicitation or an offer to buy or sell any securities and should not be treated as giving investment advice to recipients. It is not targeted to the specific investment objectives, financial situation or particular needs of any recipient. It is not intended to provide the basis for any third-party evaluation of any securities or any offering of them and should not be considered as a recommendation that any recipient should subscribe for or purchase any securities. Forward-Looking Statements 2
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Welcome and Agenda 3 Andreas Harstrick, MDChief Medical Officer Valentina Boni, MD, PhDDirector of Clinical Cancer Research, Quirónsalud in Madrid •Welcome and IntroductionsDr. Shawn Leland•AFM24-102 in NSCLC: Current data & clinical contextDr. Valentina Boni •AFM24 Post-Hoc Exposure-Response AnalysisDr. Andreas Harstrick •Closing RemarksDr. Shawn Leland•Questions & AnswersAll Shawn Leland, PharmD, RPhChief Executive Officer
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AFM24-102 NSCLC EGFR Wild-typeCutoff: November 14, 2024
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5 AFM24-102 NSCLC EGFRwt: Patient Disposition Patients DispositionNPatients in the FAS1 43 Patients with no valid scan (yet)Reasons:10•6 early PDs (<4 weeks)•2 discontinued due to non-related AE•2 ongoing with no scan yetPatients in the PPS2 33 Data cut: November 14, 2024. Data not validated, not cleaned, subject to change1 FAS: (full analysis set), includes all patients who received at least any amount of the combination treatment2 PPS (per protocol set): RECIST evaluable set include all patients from the FAS with a valid post-baseline scan at least 42 days after C1D1
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6 AFM24-102 NSCLC EGFRwt Expansion Cohort: Patient Characteristics Data cut: November 14, 2024. Data not validated, not cleaned, subject to change Patient CharacteristicsNSCLC EGFRwt cohortFAS (N = 43)PPS (N = 33)Age (years)Median (Range)67 (40-79)68 (40-79)Sex (n (%))MaleFemale31 (72.1%)12 (27.9%)24 (72.7%) 9 (27.3%)Race (n (%))WhiteAsianBlack or African American26 (60.5%)16 (37.2%)1 (2.3%)19 (57.6%)13 (39.4%)1 (3%)Histological type at diagnosisAdenocarcinomaSquamous cell carcinomaNSCLC, other23 (53.5%)13 (30.2%)7 (16.3%)19 (57.6%)10 (30.3%)4 (12.1%)ECOG PS (n (%))01 6 (14.0%)37 (86.0%)3 (9.1%)30 (90.9%) Patient CharacteristicsNSCLC EGFRwt cohortFAS (N = 43)PPS (N = 33)Number of metastatic sitesMedian (Range)2 (1-4)2 (1-4)Number of prior lines of treatmentMedian (Range)2 (1-7) 2 (1-7)Prior therapy (n (%))Platinum-based chemotherapyCPITaxane43 (100%)43 (100%)28 (65%)33 (100%)33 (100%)21 (64%)Discontinuation of anti-PD(L)1 therapy due to progression42 (97.7%)32 (97.0%)PD(L)1 expressionExpressionNot expressedNot tested / unknown4 (9.3%)8 (18.6%)31 (72.1%)2 (6.1%)6 (18.2%)25 (75.8%)
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AFM24-102 NSCLC EGFRwt: AFM24 and Atezolizumab are Well Tolerated with No Unexpected Safety Findings 7 Data cut: Nov 14, 2024. Data not validated, not cleaned, subject to changeFAS: full analysis set, includes all patients who received at least any amount of the combination treatmentEach patient is counted a single time for each applicable specific adverse event with highest severity* Increased liver enzymes: 2; IRR/CRS: 2; pneumonitis: 1ALT = alanine aminotransferase; AST = aspartate aminotransferase; IRR = infusion-related reaction; TEAE = treatment emergent adverse event; TRAE = treatment-related adverse event AFM24 plus atezolizumab exhibited a tolerable, well-managed safety profile AEsN = 43Any GradeN (%)Grade 3+N (%)Any AE42 (97.7) 24 (55.8)Infusion Related Reaction23 (53.5)2 (4.7)ALT Increased9 (20.9)2 (4.7)Fatigue8 (18.6)-AST Increased7 (16.3)2 (4.7) Related AEsN = 43Any GradeN (%)Grade 3+N (%)Any related AE35 (81.4) 5* (11.6)Infusion Related Reaction23 (53.5)2 (4.7) Most common AEs in >15% patientsMost common AFM24-related AEs in >15% patients All transaminase elevations (ALT/AST) were transient; IRRs were manageable, mostly present during the first infusion, and fully resolved
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8 •Disease control rate 76%•Tumor shrinkage in 48% (16/33 pts1)•Objective response rate•21% ORR(1 CR; 6 PRs)•18% confirmed (1 PR* pending confirmation)•Of the7 patients with a response: •5 of7 never achieved an ORR on previous CPIs •2 PRs - combination CPI + doublet chemotherapy•Documented PD on previous CPIin all 7 patients Efficacy Highlights and Considerations AFM24-102 NSCLC EGFRwt Expansion Cohort Demonstrates Early Compelling Efficacy That is Competitive With Current 2L/3L Therapies Data cut: November 14, 2024. Data not validated, not cleaned, subject to change* According to RECIST 1.1, a subsequent second scan is required for confirmation1 PPS (per protocol set) = valid post-baseline efficacy scan according to RECIST 1.1, N=33 is denominator for all rates provided on this slide Best Percent Change From Baseline (N = 33, PPS) *
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9 AFM24 Plus Atezolizumab Induced Durable Responses in Heavily Pretreated EGFRwt NSCLC Patients with 36% of PPS Patients Ongoing Data cut: November 14, 2024. Data not validated, not cleaned, subject to changeAccording to RECIST 1.1, a subsequent second scan is required for confirmationPPS (per protocol set) = valid post-baseline efficacy scan according to RECIST 1.1, N = 33 is denominator for all rates provided on this slide
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10 AFM24 Plus Atezolizumab Induced Lasting Remissions in Heavily Pretreated EGFRwt NSCLC Patients Preliminary Median PFS (36% of patients ongoing)PFS: 5.6 months Median follow-up: 7.5 months
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11 Patient Population Matters: Patients with Prior Taxane Exposure Show a Lower Objective Response Rate and a Shorter Median PFS Best Confirmed ResponsePrior Taxane:NO (N = 12)Prior Taxane:YES (N = 21)Complete Response1 (8.3%)0 (0.0%)Partial Response2 (16.7%)3 (14.3%)Progressive Disease3 (25.0%)5 (23.8%)Stable Disease6 (50.0%)13 (61.9%)ORR25.0%14.3% Preliminary Median PFSPFS: 7.4 vs. 4.4 months Objective Response RateMedian PFS
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12 Case Study: A Patient Exhibiting a PR Experienced a 35% Overall Shrinkage of Their Target Lesions With AFM24 and Atezolizumab 66-year-old maleDiagnosed in 2019 as 3B, treated with CTRT Metastatic lung adenocarcinomaTP53 mutated•Stage IV with two target lesions: Left Upper Lobe (LUL) and Left Adrenal gland. No non-target lesions Patient Background & Treatment History Jun 2020– Mar 2021Carboplatin + PemetrexedBOR = SDDiscontinued due to PD Mar 2021– Sep 2022NivolumabBOR = SDDiscontinued due to PD Dec 2022– Mar 2023Docetaxel BOR = SD Discontinued due to PD CT scan images of the LUL lesion (white arrow) and the left adrenal (green arrow) of a patient exhibiting a confirmed PR on 480 mg AFM24 + Atezolizumab Treatment with 480 mg AFM24 Initiated 31 May 2023 Jul 2022 Oct 2022 BOR = best objective responseCT = computerized tomographyNSCLC = non-small cell lung cancerPD = progressive disease PR = partial responseSD = stable disease Tumor Response by Investigator Assessment per RECIST v1.1 01020304050607080 Sc reeni ng5/2 4/20 23TA17/2 8/20 23TA29/2 1/20 23TA311 /17/2 023TA412 -JAN-2024TA509 -FEB-20 24 Target lesions and Sum of Diameters in mm TL1: Lung, left upper lobeTL2: Left Adr enal glandSUM
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AFM24-102 NSCLC EGFR MutantUpdate of first 17 patients
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14 AFM24 + Atezolizumab NSCLC EGFRmut - Patient disposition Data cut: November 14, 2024FAS: full analysis set, includes all patients who received at least any amount of the combination treatmentPPS (per protocol set): RECIST evaluable set include all patients from the FAS with a valid post-baseline scan at least 42 days after C1D1 Patients DispositionNPatients in the FAS28Patients not included in this presentation•4 early PDs (<4 weeks)•2 discontinued due to unrelated AE•5 no scan or no evaluation yetPatients update in this presentation 17 patients from the PPS (same patients as presented during Q2 EC)
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15 AFM24 + Atezolizumab NSCLC EGFRmut – Baseline Characteristics Data cut: November 14, 2024. Data not validated, not cleaned, subject to changePPS (per protocol set): RECIST evaluable set include all patients from the FAS with a valid post-baseline scan at least 42 days after C1D1 Patient CharacteristicsPPS populationNSCLC EGFRmut cohortN = 17 Age (years)Median (Range) 67 (32-76)Sex (N (%))MaleFemale 3 (17.6%) 14 (82.4%)Race (N (%))WhiteAsian 5 (29.4%)12 (70.6%)Histological type at diagnosisAdenocarcinoma 17 (100%)ECOG PS (N (%))01 1 (5.9%)16 (94.1%)Number of metastatic sitesMedian (Range) 2 (0-4)No. Prior Lines of treatmentMedian (Range) 3 (1-8)Prior therapy (N (%))TKI3rd generation TKIPlatinum-based chemotherapyCPI 17 (100%)14 (82.4%)13 (76.5%)2 (11.8%)
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16 AFM24 + Atezolizumab Show Meaningful Activity in Treatment Refractory NSCLC EGFRmut Patients •Tumor shrinkage in 7/17 (41%) patients •71% disease control rate•Objective response rate (24%)•1 CR (confirmed)•3 PRs (confirmed) Efficacy Highlights and Considerations Best Percent Change From Baseline (N = 17, PPS) Data cut: Nov 14, 2024. Data not validated, not cleaned, subject to changeAccording to RECIST 1.1, a subsequent second scan is required for confirmationPPS (per protocol set): RECIST evaluable set include all patients from the FAS with a valid post-baseline scan at least 42 days after C1D1
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17 AFM24 + Atezolizumab Induce Durable Responses in Heavily Pretreated NSCLC EGFRmut Patients - Update of First 17 PPS Patients: 5 Patients Ongoing for >10 months Data cut: Nov 14, 2024. Data not validated, not cleaned, subject to changeAccording to RECIST 1.1, a subsequent second scan is required for confirmationPPS (per protocol set): RECIST evaluable set include all patients from the FAS with a valid post-baseline scan at least 42 days after C1D1
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18 Case Study: A Patient Exhibiting a Partial Response with AFM24 and Atezolizumab 75-year-old femaleDiagnosed in Oct 2021 as stage IV NSCLC (adenocarcinoma) EGFR exon 19 deletionPD-L1 UK •Stage IV with three target lesions: Lymph nodes (mediastinal and left paratracheal), left upper lobe (LUL) Patient Background & Treatment History Sep – Oct 2023FurmonertinibBOR = PDDiscontinued due to PD Treatment with 480 mg AFM24 initiated on 27-Nov-2023 Tumor Response by Investigator Assessment per RECIST v1.1BOR = best objective responseCT = computerized tomographyNSCLC = non-small cell lung cancerPD = progressive diseasePR = partial response SD = stable diseaseCR = complete responseTL: Target LesionCTRT: Chemo-radiotherapy Change in SOD compared to baseline: - 32% at first PR assessment. Non-Target lesions were evaluated as without changes NTL2 Absent since TA3A case of pseudoprogressionPt #4 in theswimmerplot Dec 2021 – May 2022OsimertinibBOR = PR%Discontinued due to PD Sep 2022 – Jul 2023Platinum – Pemetrexed*BOR = UKDiscontinued due to PD 010203040506070 Sc r e e ni ng10-N OV- 2023TA 124-J AN -2024TA 226-FE B- 2024TA 320-MA R-202 4TA 416-May -2024TA 510-J ul-2024TA 612-A ug- 2024TA 704-S ep- 2024TA 829-o ct -2024 Target Lesions and Sum of the Diameters in mm TL1TL2TL3SO D CT scan images of NTL2 (Right paratracheal lymph node, pink arrow) and the mediastinal lymph node (green arrow) of a patient exhibiting a PR on 480 mg AFM24 + Atezolizumab at first TA
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19 AFM24 Plus Atezolizumab Induces Lasting Remissions in Heavily Pretreated EGFRmut NSCLC Patients with Signs of a Plateau at 30% Median PFS: 5.6 monthsMedian follow-up: >9 months
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AFM24 Post-Hoc Exposure-Response AnalysisAndreas Harstrick, MD 20
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In EGFRwt NSCLC (N = 33)•Disease control in 76%; tumor shrinkage in 48%; ORR in 21% of patients•Preliminary PFS is 5.6 months; in taxane naïve pts PFS is 7.4 months•All pts had failed platinum doublets and PD(L1) therapy; 97% had documented PD on previous PD1•65% of patients had also failed previous taxanes •Side effects were well manageable with no signs of new or overlapping toxicities In EGFRmut NSCLC (N = 17)•Disease control rate 71%; tumor shrinkage in 41%; ORR 24% of patients•After 9 months follow up PFS of 5.6 months with signs of a plateau of the PFS curve•All patients were refractory to TKIs and 76% had in addition failed platinum-based chemotherapy 21 AFM24 Plus Atezolizumab Demonstrated Meaningful Activity in Treatment Refractory NSCLC Patients The data show consistent and clinically meaningful activity in heavily pretreated NSCLC patients with a good safety profile.
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22 Exposure Response Analysis - Population and Method PopulationNMedian Mean TroughLow ExposureBelow or Equal MedianHigh ExposureAbove MedianNSCLC Trough Set (EGFRwt and EGFRmut)NSCLC patients treated with 480mg monotherapy and NSCLC patients treated with 480mg AFM24 in combination with atezolizumab4497642 ng/mLN = 22N = 22NSCLC only AFM24-102 Trough Set (EGFRwt and EGFRmut)NSCLC patients treated with 480mg AFM24 in combination with atezolizumab2686225 ng/mLN = 13N = 13 Patient Mean Trough: •A mean trough value per patient was calculated using all pre-dose PK values C1D22 and beyond •Those are divided into 2 groups (LOW, HIGH) based on median cut-point of those Mean Trough values Data cut (eCRF): July 22, 2024; only patients with available PK results were included. Patients who dropped out prior to C1D22 are NOT included.Results BLQ data are replaced by ½ LLOQ
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Low ExposureN = 22High ExposureN = 22TotalN = 44Age –mean (SD) 62.8 (12.8)61.6 (9.6)62.2 (11.2)Gender –N (%)•Male•Female 14 (63.6%)8 (36.4%)11 (50.0%)11 (50.0%)25 (56.8%)19 (43.2%)BMI –mean (SD) 24.8 (4.4)23.5 (3)24.1 (3.8)Number of prior lines -median [min -max] 2 [1 -6]3 [1 -12]2 [1 -12]Number of patients with > 1 metastatic site20 (90.9%)16 (72.7%)36 (81.8%)Baseline LDH in U/L –mean (SD) 364.6 (282.1)201.8 (69.0)283.2 (219.0)Relative dose intensity in % -mean (SD)89.7 (17.1)94.33 (6.6)92.01 (13.0)Duration of treatment in weeks –mean (SD)13.8 (11.6)31.8 (16.8)22.8 (16.9) 23 Baseline Characteristics and Exposure Data cut (eCRF): July 22, 2024. Only patients with available PK results were included.SD = standard deviation
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24 Safety Overview: Higher Exposure was Not Associated with Higher Toxicity Data cut (eCRF): July 22, 2024. Only patients with available PK results were included.Table description: N (%) [event count]SAE = serious treatment emergent adverse events, TEAE = treatment emergent adverse event Low ExposureN = 22High ExposureN = 22TotalN = 44Drug-related TEAEs19 (86.4%) [49]22 (100%) [82]41 (93.2%) [131]Serious TEAEs15 (68.2%) [28] 5 (22.7%) [8] 20 (45.5%) [36]Severe TEAEs (≥ grade 3)14 (63.6%) [27]9 (40.9%) [18]23 (52.3%) [45]Infusion related reactions14 (63.6%) [21]15 (68.2%) [17]29 (65.9%) [38] •Patients in the high groups tend to have fewer SAEs and severe TEAEs•Exposure seems to not influence the occurrence of infusion related reactions
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Objective Response Rate:Low (N=13): 1 ( 7.69%) [ 0.19 ; 36.03]High (N=13): 6 (46.15%) [19.22 ; 74.87]Significantly Better ORR in High Group 25 Objective Response Rate and Disease Control Rate:Higher Exposure Resulted in Significantly Higher Response & Disease Control Rates Data Cut (eCRF): July 22, 2024. Only patients with available PK results were included. Patients who dropped out prior to C1D22 are NOT included.DCR = disease control rate; ORR = objective response rate Disease Control Rate:Low (N=13): 5 (38.46%) [13.86 ; 68.42]High (N=13): 11 (84.62%) [54.55 ; 98.08]Significantly Better DCR in High Group 46.15 7.69 84.62 38.46 0102030405060708090 HighLowHighLow p-value: 0.073 p-value: 0.041 Objective Response Rate:Low (N=22): 1 ( 4.55%) [ 0.12 ; 22.84]High (N=22): 8 (36.36%) [17.20 ; 59.34]Significantly Better ORR in High Group Disease Control Rate:Low (N=22): 8 (36.36%) [17.20 ; 59.34]High (N=22): 19 (86.36%) [65.09 ; 97.09]Significantly Better DCR in High Group 36.36 4.55 86.36 36.36 0102030405060708090100 HighLowHighLow p-value: 0.021 p-value: 0.002 NSCLC only AFM24-102 Trough SetNSCLC (EGFR wt & mut): 480 mg AFM24 plus atezolizumabNSCLC Trough Set NSCLC (EGFR wt & mut): 480 mg AFM24 AND 480 mg AFM24 plus atezolizumab
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26 Increasing Exposure Resulted in Higher Objective Response Rate, More Stable Diseases and Higher Disease Control Rate Group Mean ThroughQ1 (0-25%)N = 11 Group Mean ThroughQ2 (25-50%)N = 11 Group Mean ThroughQ3 (50-75%)N = 11 Group Mean ThroughQ4 (75-100%)N = 11 OverallN = 44 Mean Trough Level [ng/ml](mean of each group)3199180447121555173299101823 Complete response0 (0.00%)0 (0.00%)0 (0.00%)1 (9.09%)1 (2.27%)Partial response0 (0.00%)1 (9.09%)2 (18.18%)5 (45.45%)8 (18.18%)Stable disease2 (18.18%)5 (45.45%)7 (63.64%)4 (36.36%)18 (40.91%)Progressive disease6 (54.55%)3 (27.27%)1 (9.09%)1 (9.09%)11 (25.00%)Missing3 (27.27%)2 (18.18%)1 (9.09%)0 (0.00%)6 (13.64%)Overall Response Rate01 (9.09%)2 (18.18%)6 (54.55%)9 (20.45%)Disease Control Rate2 (18.18%)6 (54.55%)9 (81.82%)10 (90.91%)27 (61.36%) Clear trend: increased efficacy from lowest to highest exposure groups for both ORR and DCRSubjects with mean trough value based on all pre-dose PK results from C1D22 and beyond
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Progression Free Survival (PFS): Lower Exposure Was Associated with Increased Risk of Early Progression LOW HIGH Median PFS (months)1.8727 7.3265 95% CI1.5113 ; 2.89123.7125 ; 9.2649 LOW HIGH Median PFS (months)1.922 7.4251 95% CI1.347 ; 5.9466 2.8912 ; - 27 p-value: 0.003 NSCLC only AFM24-102 Trough SetNSCLC (EGFR wt & mut): 480mg AFM24 plus atezolizumabNSCLC Trough Set NSCLC (EGFR wt & mut): 480mg AFM24 AND 480mg AFM24 plus atezolizumab
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Overall Survival (OS): Patients with High Exposure Showed Improved Survival LOW HIGH Median OS (months)16.3614 - 95% CI2.8583 ; - 10.7105 ; - LOW HIGH Median OS (months)16.3614 - 95% CI - ; - - ; - 28 NSCLC only AFM24-102 Trough SetNSCLC (EGFR wt & mut): 480mg AFM24 plus atezolizumabNSCLC Trough Set NSCLC (EGFR wt & mut): 480mg AFM24 AND 480mg AFM24 plus atezolizumab
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Trough concentration [ ng/mL] Add-On: 720 mg Exposure and Safety OverviewAFM24-101 Phase 1 •A 720 mg dose results in trough levels above the efficacy threshold in all patients by week 3•Safety between 480 mg and 720 mg is comparable 29 AFM24-101 Phase 1480 mgN=6720 mgN=6Drug-related TEAEs6 ( 100%) [31]6 ( 100%) [47]Serious TEAEs0 ( 0.0%) [0] 0 ( 0.0%) [0] Severe TEAEs (≥ grade 3)3 (50.0%) [7]3 (50.0%) [3]Infusion related reactions6 ( 100%) [9]4 (66.7%) [4] NSCLC 4th Q Mean Trough cut point: 140037 ng/mLNSCLC Median Mean Trough cut point: 97641.5 ng/mL
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30 Utilizing the 720 mg Dose Generates a Ctrough as Early as Day 8 That Exceeds the Ctrough of the High Exposure Group Low Group: N = 22 (NSCLC)High Group: N = 22 (NSCLC)720mg: N = 6Starting Day 15: •High and Low Ctrough distinguished clearly•720 mg above High GroupReference Line: Median Cut Point (Low vs. High)
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31 Key Conclusions from AFM24 Clinical Data and Dose-Exposure Response Analysis 1)Confirmation: updated data confirms meaningful clinical activity including response and durability in heavily pre-treated patients 2)Prior taxane exposure matters: patients without prior taxane exposure have a mPFS 7.4 months3)AFM24 exposure matters: higher AFM24 exposure results in higher ORR, mPFS and OS Meaningful opportunity to increase the ORR in these patients >30% and mPFS >7 months
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Closing RemarksShawn Leland, PharmD, RPh
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Three Ongoing Studies with ICE® Confirm the Potential of the Innate Immune System in Fighting Cancer Latest AFM24 + atezolizumab results•Data show consistent and clinically meaningful activity in heavily pretreated NSCLC patients with a tolerable safety profile•Further development is justified at the higher dose of 720 mg weekly either as a doublet or in combination with SoC agents•Patient selection such as prior taxane exposure andintensified dosing present strategies to increase the ORR in these patients to >30% and mPFS >7 months AFM24 in advanced EGFR+NSCLC in combination with PD-L1 ASH 2024: Run-in LuminICE-203 study of Acimtamig + AlloNK® •Data shows outstanding therapeutic efficacy in multi-refractory Hodgkin lymphoma (HL) patients and •In 22 heavily pretreated r/r HL patients who exhausted SOC treatment optionsshow an ORR 86% with 12CRs (55%)RMAT designation granted by FDA•Based on promising early efficacy and safety data in r/r/HL, and offers benefits to facilitate expedited review and approval Acimtamig (AFM13) + NK cells in r/r HL ASH 2024: Initial Ph 1 results •Data show promising single agent activity in refractory AML with a manageable safety profile•In the highest dose level (300 mg), a composite complete remission rate of 40% was achieved as best response AFM28 inon r/r AML EGFR CD30 CD123 AML= acute myeloid leukemia;; HL = Hodgkin lymphoma The company is projected to end Q4 2024 with ~€15M and cash runway projected into Q4 2025 33
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Q&A 35
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Back-up 36
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37 How Could AFM24 Efficacy be Further Improved? * Trough Set - all NSCLC subjects from AFM24-101 (AFM24 monotherapy) and AFM24-102 (AFM24 + atezolizumab) with 480 mg AFM24 and with pre-dose PK results available from C1D22 or laterNE = not estimable Question: Despite the observed higher ORR and increased PFS vs. the benchmark, we asked the question how the efficacy of AFM24 could be further improvedØIs an an ORR >30% achievable?ØIs a PFS beyond 7 months possible? Hypothesis: Higher AFM24 exposure results in higher ORR and PFS with a tail of the curve effect which we believe will lead to a prolonged OS without jeopardizing patient safety Approach: Conduct a post-hoc exposure-response analysis in NSCLC EGFRwt & EGFRmut patients treated in the AFM24-102 study with AFM24 (480 mg) + atezolizumab Result: Higher exposure vs. lower exposure resulted in significantly higher efficacy with no negative effect on safety AFM24 High ExposureLow ExposureORR [%]365PFS [months]7.3 1.9OS [months]NE16.4 *
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MutationN= 17 Exon 19 del8Exon 19 del +T790M2Exon 21 (L858R)3Exon 21 + T790M1Exon 21 + Exon 20 (S768I)1Exon 18 (G719X)1Exon 18 (G719X) + Exon 20 (S768I)1 EGFR Mutations reported in EXP-4 (NSCLC, EGFRmut) Data cut: Nov 14, 2024. Data not validated, not cleaned, subject to change38