Slide 1: Redefining Standard of Care in Advanced Melanoma
Redefining Standard of Care in Advanced Melanoma SCOPE data update 11 December 2025
Slide 2: Disclaimer
DISCLAIMER For the purposes of this disclaimer, this “presentation” shall mean and include the slides that follow, the oral presentation of the slides by Scancell Holdings plc (the “Company”) or any person on its behalf, any question-and-answer session that follows the oral presentation, hard copies
Slide 3: Key Highlights: SCOPE Study Data Update
KEY HIGHLIGHTS S C O P E ST U DY DATA U P DAT E Strong progression free survival signal with iSCIB1+ and CPIs demonstrating 74% PFS at 16 months 24% PFS delta over real world standard of care and historic controls Strong PFS data continues across key poorer prognosis sub-groups Early overall s
Slide 4: iSCIB1+ has the potential to create a new standard of care for melanoma
iSCIB1+ has the potential to create a new standard of care for melanoma ~325,000 global melanoma incidence 1 Unmet Need Approved Therapies Resectable Melanoma Stage IB - IIIA Pembrolizumab (Keytruda) ~58,000 deaths per year Neoadjuvant Checkpoint Inhibitor Monotherapy * Ipilimumab (Yervoy) plus Nivo
Slide 5: Commercial Building Blocks in Place
COMMERCIAL BUILDING BLOCKS IN PLACE AC C E L E R AT E D P L A N N I N G F O R P H A S E 3 D E V E LO P M E N T PRODUCT IP MANUFACTURING DELIVERY REGULATORY COMMERCIAL Meaningful Off the shelf Regulatory support Partnering for Clinical benefit Needle-free Strong worldwide IP FDA seamless Convenient f
Slide 6: iSCIB1+: The Science
iSCIB1+ The Science 6
Slide 7: iSCIB1+ is a DNA ImmunoBody with a novel mechanism of action
ISCIB1+ IS A DNA IMMUNOBODY® WITH A NOVEL MECHANISM OF ACTION First Generation Second Generation Target Delivered Needle-Free into patients binding FC region HLA A2 Restricted Broader HLA Population AvidiMab® FC modification • DNA ImmunoBody is a plasmid encoding a modified antibody; • Target Bindin
Slide 8: iSCIB1+: The Studies
iSCIB1+ The Studies 8
Slide 9: SCOPE Study in First Line Advanced Melanoma
SCOPE STUDY IN FIRST LINE ADVANCED MELANOMA Phase 2 open label parallel multi cohort translational study at 16 UK clinical trial sites enrolling over 100 patients Objective: select product, target population, dosing schedule and endpoints for follow-on phase 3 trial STUDY POPULATION Cohort 1 (n=43)
Slide 10: Baseline Characteristics in SCOPE Study
BASELINE CHARACTERISTICS IN SCOPE STUDY IN LINE WITH HISTORIC CONTROLS SCIB1 iSCIB1+ ipi + nivo Cohort 1: (n=43) Cohort 3 (n=50) Checkmate 067 Gender Male 28 (65%) 21 (42%) 64.6% Female 15 (35%) 29 (58%) 35.4% Age <65 20 (47%) 33 (66%) 59.8% ≥65 - <75 11 (25%) 15 (30%) 27.7% ≥75 12 (28%) 2 (4%) 12.5
Slide 11: iSCIB1+: PFS in Target HLA Population Against Historic Controls
iSCIB1+: PFS IN TARGET HLA POPULATION AGAINST HISTORIC CONTROLS S T R O N G D E LTA O V E R I P I L I M U M A B A N D N I V O L U M A B F R O M C H E C K M AT E 0 6 7 1.0 • iSCIB1+ shows 24% delta 0.9 over median PFS for SoC (ipi/nivo, Checkmate 067) 0.8 PFS at 16iSCIB1+ months = 74% 0.7 Median (50%
Slide 12: iSCIB1+ More Than Doubling PFS vs Standard of Care Alone
iSCIB1+ MORE THAN DOUBLING PFS VS STANDARD OF CARE ALONE BEST IN CLASS THERAPY POTENTIAL STANDARD OF STANDARD OF iSCIB1+ Combined Relativity 047 CARE CARE (COHORT 3) Cohorts (CHECKMATE 067) (REAL WORLD) Patient numbers 39* 80* 355 314 Nivolumab + Nivolumab + Anti-LAG-3 + Combination Agents Nivolumab
Slide 13: Clinically Meaningful Benefit in All Subgroups Analysed
CLINICALLY MEANINGFUL BENEFIT IN ALL SUBGROUPS ANALYSED S C O P E S T U D Y S U B G R O U P A N A LY S I S A C R O S S C O M B I N E D C O H O R T PAT I E N T S Study BRAF Status 2 Prior CPI (+/-) PD-L1 Status3 BRAF WT BRAF MT No Prior CPI Prior CPI PD-L1 <1 PD-L1 ≥1 63% at 21m 70% at 21m 63% at 24m
Slide 14: Impressive Efficacy and Disease Control in Target HLA Population
IMPRESSIVE EFFICACY AND DISEASE CONTROL IN TARGET HLA POPULATION SCIB1 AND iSCIB1+ WITH SOC, IPILIMUMAB AND NIVOLUMAB (N=80) PD SD PR CR RESPONSES ORR: 60% (48/80) 15 17 36 12 DCR: 81% (65/80) 14
Slide 15: Long Term Tumour Control Reflected in Durability
LONG TERM TUMOUR CONTROL REFLECTED IN DURABILITY S C I B 1 A N D i S C I B 1 + S P I D E R P LOT S ( A L L TA RG E T P O P U L AT I O N ) SCIB1 (N=41) TARGET POPULATION (HLA-A2) iSCIB1+ (N=39) TARGET POPULATION (HLA-A2, A3, A31, B35,Bw4, A33, B44) 15
Slide 16: Interim Safety Summary – SCIB1 & iSCIB1+ (N=133)
INTERIM SAFETY SUMMARY – SCIB1 & iSCIB1+ (N=133) T H E S A F E T Y P RO F I L E O F i S C I B 1 + I S B E N I G N W I T H N O P OT E N T I AT I O N O F TOX I C I T I E S OF THE CHECKPOINT INHIBITORS SCIB1 and iSCIB1⁺ was generally safe & well tolerated at 0.4 - 8mg dose: Number of events (% of patie
Slide 17: Strong T-cell Responses to iSCIB1+ Epitopes Observed
STRONG T-CELL RESPONSES TO iSCIB1+ EPITOPES OBSERVED Best T cell response Cohort 3 POSITIVE 1400 CLINICAL NUMBER OF T CELL % POSITIVE <0.0001 RESPONSE PATIENTS 1300 RESPONSE Nomalised spot count per million cultured PBMCs 1200 CR/PR 19 15 79% 1100 1000 SD 7 5 71% 900 Peptide recognised TRP2-180 PD 7
Slide 18: Phase 3 Double Blinded Randomised Adaptive Registrational Study
PHASE 3 DOUBLE BLINDED RANDOMISED ADAPTIVE REGISTRATIONAL STUDY I N D I CAT I V E P L A N Selected Product: Post Registration iSCIB1+ Registration (in-market) Analysis Analysis Target Population: • Stage III & IV unresectable melanoma iSCIB1+ ipi +nivo • HLA Haplotypes: A2, A3, 1:1 A31, B35, B44, Bw
Slide 19: Regulatory Strategy with Positive Momentum
Regulatory Strategy with positive momentum MHRA FDA • Scientific review meeting held • Type B/Pre-IND meeting held • Good alignment with FDA perspectives (less detailed feedback at this time) • Accepted our proposed 8mg intramuscular dose (Project Optimus ✓) • Data, study design and stats plan, endp
Slide 20: What do we know today about the Pharma perspectives?
What do we know today about the Pharma perspectives? PROGRAM CURRENT PERSPECTIVES POSITIVE ATTRIBUTES • Melanoma is treated well with CPIs • Strong Phase 2 data emerging, well tolerated • Cancer vaccines – limited success to date • Novel mechanism and platform • CPIs are becoming legacy pipeline for
Slide 21: Scancell Outlook
Scancell Outlook 21
Slide 22: Scancell Development Milestones
SCANCELL DEVELOPMENT MILESTONES M U LT I P L E M I L E S T O N E S A C H I E V E D W I T H P H A S E 3 P L A N N I N G O N T R A C K 2025 2026 2025 Q4 Q1 2026+ NHS CVLP Partnership ✓ iSCIB1+ cohort 3 enrolment ✓ iSCIB1+ PFS and early Overall Survival data ✓ SCIB1+ IND open P3 randomised study1 SCIB1
Slide 23: iSCIB1+ Ready for Phase 3 Development
iSCIB1+ READY FOR PHASE 3 DEVELOPMENT Scalable manufacturing in place • High quality formulation with long-term stability • GMP manufacturing for late-stage development Future development will take in Needle-free device license agreement secured account timely development and • Stratis® Intramuscula
Slide 24: iSCIB1+ Ready to Redefine Standard of Care in Advanced Melanoma
iSCIB1+ READY TO REDEFINE STANDARD OF CARE IN ADVANCED MELANOMA The prolonged progression free survival demonstrates iSCIB1+ in combination with checkpoint inhibitors has potential to redefine standard of care. This therapy combination increases the number of advanced melanoma patients who would ben
Slide 25: Thank you for listening Q&A session
Thank you for listening Q&A session 25