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Clinical Stage Cancer ImmunotherapyPresentation to Oxford Technology VCT AGMAugust 26th 2015Dr Richard Goodfellow: Joint CEO, Scancell

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COMPANY PROFILE

Focus on cancer immunotherapy

Two cutting edge platform technologies – ImmunoBody ®and Moditope®

Unprecedented clinical efficacy and safety on lead product SCIB1 for patients with Stage 3/4 resected metastatic melanoma

Deep pipeline of ImmunoBody vaccines ready for further development

First Moditope product (Modi-1) ready to enter clinical trials in 2016

Discussions on various options for future development of business ongoing

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QUOTE FROM US MELANOMA SPECIALIST, AUGUST 2015

“There is a giant hole in the management of melanoma patients and a huge need for good adjuvant therapies”

“Ipi (Yervoy), although effective is highly toxic. That’s why SCIB1 is so attractive”

“The (SCIB1) data are compelling..”

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VALUE DRIVERS

SCIB1 targeting adjuvant melanoma • Unparalleled survival and safety in Stage 3/4 patients• Huge untapped market• Little current or future competition for adjuvant use• Planned Phase 3 pivotal trial to secure approval based on DFS advantage

Deep ImmunoBody® vaccine pipeline• SCIB2 targeting NY-ESO-1 ready to enter clinical trials for lung and other epithelial cancers• Flexible platform generates new candidates for further testing in weeks

Moditope® platform offers completely novel and patented approach to T cell stimulation. Highly effective anti-tumour effects and survival benefits in animal studies

Modi-1 ready to enter clinical trials, probably for triple negative breast cancer, in late 2016

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ACTIVE CANCER IMMUNOTHERAPY USING IMMUNOBODY®

Checkpoint inhibitors have clearly demonstrated that T cells can recognise and kill even bulky tumours

Most cancer vaccines have failed to deliver robust clinical results in the past as they do not generate the HIGH AVIDITY, POTENT, T-CELL RESPONSES required for cell killing

Scancell’s research has shown that the optimal way of producing specific high avidity T cells is by using its DNA ImmunoBody® technology combined with electroporation (TriGrid, Ichor Medical Systems). This approach is extending the lives of melanoma patients with minimal residual disease following surgery

Combining safe and effective T cell stimulation with SCIB1 with checkpoint inhibitors is a logical approach for late stage patients

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IMMUNOBODY® T CELL ACTIVATION

ImmunoBody® T cell activators are DNA vectors that encode engineered human antibody molecules that target only the high affinity CD64 receptor on activated dendritic cells

T cell epitopes are inserted into the COMPLEMENTARITY DETERMINING REGIONS [CDRs] of the antibody framework to make a genetic antigen/antibody complex

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SCIB1 IMMUNOBODY® DESIGN

SCIB1 ImmunoBody® incorporates epitopes from over-expressed melanoma differentiation antigens TRP-2 and gp100, grafted into its Complementarity Determining Regions (CDRs)

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SCIB1 IMMUNOBODY® DELIVERY

DNA treatment strategies are attractive because of the relative ease of manufacture and the excellent safety profile

However, injection of DNA alone does not result in potent immune responses in humans Electroporation generates controlled electrical pulses to create temporary pores in cell membranes and facilitates

a dramatic increase in DNA uptake; it also acts like an adjuvant and induces inflammation SCIB1 is injected using the TriGrid electroporation device (Ichor Medical Systems) The TriGrid 1.0 delivery system is a compact hand-held device that contains a syringe needle and four recessed

electrodes

Figure 2.

Integrated Applicator

PulseStimulator

Application Cartridge

Electrodes

InjectionNeedle

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SCIB1 INDUCES HIGHER AVIDITY T CELLS THAN OTHER APPROACHES

SCIB1 DNA induces similar frequency responses to dendritic cells (DC) pulsed with TRP-2 peptide

However, avidity of SCIB1 DNA response is 10x higher than DC + peptide

Whole antigen DNA or peptide alone induce low frequency, low avidity responses

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SCIB1-001 STUDY DESIGN USED FOR PHASE I/II TRIAL

PHASE 1 STUDY IN PATIENTS WITH STAGE III/IV MELANOMA WITH TUMOUR PRESENT

Primary Objective – safety and tolerabilitySecondary Objectives – immune responses; tumour responses

Dose escalation with safety assessment after 3 doses (0.4 mg, 2 mg, 4 mg, 8mg)

PHASE II STUDY IN PATIENTS WITH FULLY RESECTED STAGE III/IV MELANOMA

Primary Objective – safety and tolerabilitySecondary Objectives – immune responses; disease free survival

STUDY SCHEDULEPatients dosed at Weeks 0, 3 and 6 weeks with boosts at 3 and 6 monthsImmune samples taken pre- and post-dosingOptional continuation phase with dosing every 3-6 months for up to 5 years

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SCIB1-001 STUDY DESIGN USED FOR PHASE I/II TRIAL

PHASE 1/2 STUDY IN PATIENTS WITH STAGE III/IV MELANOMAPrimary Objective – safety and tolerabilitySecondary Objectives – immune responses; tumour responsesPart 1, cohorts 1, 2, 3 – dose escalation with safety assessment after 3 doses (0.4 mg, 2 mg, 4 mg)Part 2, cohort 1 – resected patients at highest tolerated dose (4 mg)

No Maximum Tolerated Dose identified in Part 1; formulation improvements enabled higher dose to be evaluated…Part 1, cohort 4 – additional dose escalation cohort added (8 mg)Part 2, cohort 2 – additional patients currently being dosed at 8 mg dose

STUDY SCHEDULEPatients dosed at Weeks 0, 3 and 6 weeks with boosts at 3 and 6 monthsImmune samples taken pre- and post-dosingOptional continuation phase with dosing every 3-6 months for up to 5 years

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CLINICAL SAFETY PROFILE – SCIB1 IS WELL TOLERATED

No dose-limiting toxicities observed

No adverse events (AEs) leading to discontinuation of study treatment

Vast majority of AEs were CTC grade 1 or 2

No CTC grade 4 or 5 toxicities other than those related to disease progression and one episode of pneumonia (grade 4)

Most common AEs were transient – injection site pain, tenderness, bruising and fatigue

None of the serious AEs reported were related to study drug or study device

Electroporation causes transient pain in some patients One patient withdrew after three doses; one declined a final injection Study drug has been given on more than 190 occasions without any other patients withdrawing consent

Safety profile compares very favourably with several of the checkpoint inhibitors where up to 13% of patients on pembrolizumab and 20% of patients on ipilimumab experience grade 3-5 adverse events, predominantly autoimmune complications

Mild side effects of SCIB1 suggest treatment would be acceptable in early stage patients post-surgical resection (adjuvant setting)

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PART 1 – TUMOUR RESPONSES AND DISEASE CONTROL

5 of 11 patients (45%) in Part 1 receiving a 2-8 mg dose of SCIB1 have shown evidence of either an objective tumour response or disease control:

Patients with tumour present at study entry:

One patient (04-16) receiving 4 mg doses showed a “differential response” pattern in which multiple lung lesions decreased in size or disappeared completely, whereas one abdominal wall nodule grew and was resected – immunohistochemistry showed high levels of PD-L1 to be present

One patient (04-28) receiving 8 mg doses showed a size reduction in all lung lesions, resulting in a partial response as defined by RECIST by Week 9 and these lesions continued to decrease in size through Week 18 and 28; two new subcutaneous lesions developed and SCIB1 dosing ceased

A second patient (04-27) receiving 8 mg doses, with lung and breast metastases at study entry, had disease at the end of the main study period; thereafter the breast lesion remained stable but the lung lesion increased slowly over the next 3 months

Patients with fully-resected disease at study entry:

One patient (01-24) receiving 2 mg/4 mg doses has been disease-free for 49 months having previously been treated every year for 5 years with recurrent skin and lymph node disease

One patient (04-03) receiving 4 mg doses remained disease-free for 18 months having previously required the resection of multiple metastases

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CT LUNG SECTIONS FROM PART 1 PATIENTS

Two patients showed objective clinical responses CT scans showed tumour regression/disappearance Patient 04-16 received 4 mg doses and patient 04-28 received 8 mg doses of SCIB1

Survival of Part 2 patients with Resected Disease (4mg dose)

OVERALL SURVIVAL:Patients with fully-resected tumour at study entry (n=16)

Median overall survival not reached

Swimmer Plot of survival of Part 2 patients with resected disease (4mg dose)

01-24

01-34

05-08

01-37

05-09

01-32

04-03

05-24

02-33

05-21

05-19

05-11

04-22

05-13

02-21

05-18

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Sixteen patients (two from Part 1 and 14 from Part 2) with fully-resected metastatic disease at study entry were recruited; nine with Stage III and seven with Stage IV disease prior to resection

All 16 patients remain alive, with a current median observation time of 36 months (range 29-49) from study entry and only five patients (31%) have had a recurrence of disease

Compares favourably with a peptide vaccine trial in patients with fully-resected Stage III/IV disease (Slingluff et al 2011)

Response of Stage IV patients compares favourably with a SouthWest Oncology Group study (Sosman et al 2011)

Fully resected melanoma

patients

SCIB1 Peptide vaccine Untreated

No Patients Progressed (%) Died(%)

Progressed (%) Died(%)

Progressed (%) Died(%)

2 yr 3 yr 2 yr 3 yr 2 yr 3 yr 2 yr 3 yr

Stage III/IV 1 16 31 0 44 48 12 21

Stage IV 2 7 29 0 77 84 53 64

Median follow up at 36 months: Survival and progression at 2 and 3 years:

1Slingluff et al 2011; 2Sosman et al 2011

SURVIVAL AND PROGRESSION OF ALL RESECTED PATIENTS

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SCIB1 CLINICAL TRIAL – HIGHLIGHTS

SCIB1 is safe and well tolerated

24/28 patients have developed melanoma-specific immune responses (clear dose response) Only one response to 0.4 mg dose – all patients progressed with a median survival of 7 months as

expected for Stage IV patients 5/6 responded to 2/4 mg (Part 1) with a current median survival of 37 months from trial entry 4/5 responded to 8 mg (Part 1) with a current median survival of 17 months from trial entry 14/14 patients with resected tumour (Part 2) responded to 4 mg dose 8 mg cohort made a 10-fold higher response than 4 mg cohort as measured by Elispot

Five of 11 (45%) patients in Part 1 receiving a 2-8 mg dose of SCIB1 have shown evidence of a clinical response Reduction in tumour size or complete destruction of tumours Progression free survival Stable disease

All 16 resected patients (two in Part 1 and 14 in Part 2) are still alive (median survival 35 months) and only five have progressed

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SUMMARY OF SCIB1

Scancell’s ImmunoBody® platform, in combination with electroporation, has set a new standard for T cell activation

SCIB1 shrinks and even destroys tumours in patients with inoperable metastatic melanoma

SCIB1 prevents disease recurrence and prolongs overall survival in patients with fully resected disease

SCIB1 is safe and well tolerated

Synergy of ImmunoBody® with checkpoint inhibitors in animal studies demonstrates potential for combination use in late stage patients

Simple and relatively inexpensive to manufacture

Safety and efficacy profile of SCIB1 suggests future role in adjuvant melanoma – a huge and unmet medical need

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OUR VISION FOR FUTURE IMMUNOTHERAPY OF MELANOMA

Stage * Incidence(%)

5 year survival (%)

Therapy

1A67

97 Surgery

IB 92 Surgery

IIA

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81 Surgery, SCIB1

IIB 70 Surgery, SCIB1

IIC 53 Surgery, SCIB1

IIIA**

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78 Surgery, SCIB1

IIIB 59 Surgery, SCIB1, checkpoint inhibitors, BRAF inhibitors

IIIC 40 Surgery, SCIB1, checkpoint inhibitors, BRAF inhibitors

IV 1 15-20

Checkpoint inhibitorsBRAF inhibitorsTvecCAR-T, TCRSCIB1 combined with checkpoint inhibitors

*Stage based upon thickness of lesion, ulceration, spread to lymph nodes and spread to other organs**The survival rate is higher for Stage IIIA cancers than for some Stage II cancers. This is likely because the main (primary) tumour is often less advanced for IIIA cancers, although this is not clear.

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MODITOPE®

Moditope® is a new and proprietary platform for activating the immune system against tumour cells

Moditope® exploits the normal immune response to stressed cells, which is largely mediated by cytotoxic CD4+ T cells

When normal cells are stressed or dying, they start to digest their own internal proteins (autophagy)

Activated enzymes modify the digested protein fragments and convert certain arginine amino acids to citrulline

THESE MODIFIED T CELLS CAN BE HARNESSED

TO KILL TUMOUR CELLS

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MODI-1 STIMULATES POTENT ANTI-TUMOURRESPONSES EVEN AGAINST DAY 14 ESTABLISHED TUMOURS

B16 tumour established in DR4 mice (Day 0) Single immunisation administered on Day 4, 7, 10 or 14 (with adjuvant)

p<0.0001

p<0.0001

p<0.0001

p=0.0012

Day7 vs Day 14 p=0.016

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MODI-1 DEVELOPMENT PLAN

On target to be ready for clinical trials in late 2016

Development activities scheduled for 2015/2016

Composition of Modi-1 finalised

Peptide manufacturing

Formulation and stability studies

Toxicity studies

Scientific advice meetings (MHRA/FDA)

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POTENTIAL SYNERGY BETWEEN IMMUNOBODY® AND MODITOPE®

ImmunoBody® Moditope®

High avidity CD8+ T cell responses Potent CD4+ T cell responses

DNA product Peptide product

Eradicates small primary and metastatic tumours

Eradicates large bulky tumours

Checkpoint inhibitors may enhance responses

No requirement for checkpoint inhibitors

Potent killer cells induced Reverses immunosuppressive tumour environment

Targets tumour-associated antigens Targets modified self-antigens

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FUTURE PLANS

Continue to strengthen and add value to SCIB1 commercial proposition

• Continue to gather survival data , especially on cohort of 20 patients with resected disease

• Detailed planning for a Phase 3 controlled trial in adjuvant melanoma including pre-IND meeting with the FDA

• Build stronger relationships with US specialists and US Patient Advocacy groups

Development of IB pipeline and Moditope

Continue to engage with pharma/biotech to optimise shareholder value

• Licensing

• M&A