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At the forefront ofcancer immunotherapy
Investor PresentationJanuary 2018
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Disclaimer
Certain statements made in this presentation are forward looking statements within the meaning of the safe harbourprovisions of the United States Private Securities Litigation Reform Act of 1995. These forward looking statements are nothistorical facts but rather are based on Viralytics’ current expectations, estimates, assumptions and projections about theindustry in which Viralytics operates. Material referred to in this document that use the words ‘estimate’, ‘project’, ‘intend’,‘expect’, ‘plan’, ‘believe’, ‘guidance’ and similar expressions are intended to identify forward looking statements and shouldbe considered an at-risk statement. These forward looking statements are not a guarantee of future performance andinvolve known and unknown risks and uncertainties, some of which are beyond the control of Viralytics or which aredifficult to predict, which could cause the actual results, performance or achievements of Viralytics to be materially differentfrom those which may be expressed or implied by these statements. These statements are based on our management’scurrent expectations and are subject to a number of uncertainties and risks that could change the results described in theforward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions andcompetition, general economic factors, the impact of pharmaceutical industry regulation and health care legislation in theUnited States and internationally, and challenges inherent in new product development. Investors should be aware thatthere are no assurances that results will not differ from those projected and Viralytics cautions shareholders andprospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view ofViralytics only as of the date of this presentation. Viralytics is not under a duty to update any forward-looking statement asa result of new information, future events or otherwise, except as required by law or by any appropriate regulatoryauthority.’
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Growing Momentum
• Lead investigational product CAVATAK® backed by growing body of clinical evidence
• Demonstrated potential across a range of indications and treatment settings
• Major opportunity for use in combination with new ‘blockbuster’ cancer immunotherapies
• Resources to conduct key global clinical trials
• Collaborative clinical trial program with Merck in lung and bladder cancer
• New studies in head and neck cancer, colorectal cancer, intravenous melanoma and uveal melanoma in advanced planning
• Corporate strategy to license, partner, or sell at key value point
CALM and CALM extension:Success in Phase 2 melanoma
trial (US)
CANON:Superficial bladder cancer (UK)
MITCI: CAVATAK / YERVOY®
Melanoma (US)
3
CAPRA: CAVATAK / KEYTRUDA®
Melanoma (US)
KEYNOTE-200: CAVATAK / KEYTRUDA®
Collaboration with Merck in lung and bladder cancer (US, AU & UK)
Key Statistics
Ticker Code ASX: VLAOTCQX: VRACY
Share Price (as at 5-Jan-18) A$0.82
Market Capitalisation (as at 5-Jan-18) A$226M
Trading Range (12-month) A$0.59 – 1.34
Institutional and Pharma investors 59%
Cash position (31 Dec 17 pro forma)1 A$57M
Net operating cash burn (Calendar 2017) A$16.4M
1 Includes $29.6 million investment and $6.4 million R&D tax incentive received since 31 December.
Company Location Comments
Leading diversified life sciences company
Private investment firm specialising in public biotechnology investments
Financial services company with over $1.5tn in assets under management
Healthcare-dedicated investment firm which manages over $14bn
Independent, trans-atlantic bio-science investment firm
Australian equities investment manager
CAVATAK® has received capital markets validation, with strong institutional investor support
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Our lead drug CAVATAK® is a bio-selected form of the common cold virus that kills cancer cells
ADMINISTRATIONMultiple routes
maximise applicability
Intravenous
Intratumoural
Intravesical
CAVATAK® kills cancer cells and stimulates the patient’s immune response
Binds externally to tumour cell
Infects cancer cell
Replicates and destroys cell
CAVATAK® is released from tumour, and the process repeats
Stimulates patient’s own immune response
against the cancer throughout the body
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Multiple CAVATAK® target areas maximise potential value, partnerships and paths to commercialisation
MELANOMA6th most common cancer
Clinical trials completedFurther underway
Pivotal trial protocolin development
HEAD & NECKBroad range of cancers
Clinical trial in planning
BLADDER5th most common cancer
Clinical trial underway
COLORECTAL4th most common cancer
Clinical trial in planning
LUNG2nd most common cancer
Clinical trial underway
Initial focusCurrent focus, to demonstrate
broad applicability of CAVATAK® in common cancer types
New high potential focus areas
Source: USA National Cancer Institute, 2016
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CLINICAL TRIAL PROGRESS
CALM Phase 2 Melanoma Study
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Day 169 (w24) irPFS
CAVATAK ® – Phase 2 CALM Melanoma Study (CAVATAK IN LATE STAGE MELANOMA)
• Leading US cancer
centres
• Responses in both
injected and metastatic
non injected tumors
• Generally well
tolerated, with no
Grade > 2 treatment-
related AEs
• Final results presented
at ASCO 2015
57 Stage IIIC and IV melanoma patientsAt least 1 injectable lesion
NOYES
10 series of multi-intratumoral CAVATAK® injections(up to 3x108 TCID50)
Day 1,3,5,8,22,43,64,85,106,127
6 Weeks later, confirmdisease progression
NO
YES
Observation only
Eligible for Extension study
9 series of multi-intratumoral
CAVATAK injections (up to 3x108 TCID50)
q21 days
8
9
IIICIV M1aIV M1bIV M1c
CR=Complete response, PR= Partial response, SD= Stable disease and PD= Progressive disease
CALM Phase 2 Trial: Impressive Response Results in Monotherapy Setting
Courtesy Dr R Andtbacka, Lead Study Investigator, Huntsman Cancer Institute as presented at ASCO 2015
Number of patients 57
Stage of Disease IIIC-IV
ir Progression-Free Survival -6 months 38.6% (22/57)
Overall Response Rate 28.1% (16/57)
Durable Response Rate (>6mths) 21.1%
Time to Response onset 3.4 mths
One-year survival rate 75.4% (43/57)
Median Overall Survival 26 months
Best percentage change in target lesions
CAVATAK ® — Well Tolerated in Clinical Testing
+, Final analysis, treatment-related adverse events were reported from 45 of the 57 treated patients (79%) enrolled in the VLA-007 CALM CAVATAK monotherapy study;*, Only Grade 1 AE’s occurring in > 10% of patients are listed.
No drug-related grade 3 or 4 or serious
adverse events
Toxicity is a well recognized shortcoming
of existing cancertherapies
Safety: CAVATAK-Related Adverse Events+
AE Term *Grade 1 n(%)
Grade 2 n(%)
Grade 3 n(%)
Grade 4 n(%)
Injection site pain 16 (28%) 2 (4%)
Tiredness (fatigue) 15 (26%) 2 (4%)
Chills 15 (26%)
Pyrexia 7 (12%)
Injection site erythema 7 (12%)
Pain 6 (11%) 1 (2%)
Myalgia 6 (11%)
Headache 6 (11%)
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CALM Phase 2 Trial: Extension Cohort (Biopsy Study) – When Checkpoint Inhibitors Fail
Day 0 (pre-treatment) Day 8 (post-treatment)
Courtesy Dr R Andtbacka, Lead Study Investigator, Huntsman Cancer Institute as presented at ASCO 2015
Patient 04-015 Stage IIIC melanoma on legsPrior treatment with ipilimumab and pembrolizumab
Patient 04-014 Stage IV M1c with melanoma to the leg and lungs. Prior treatment with ipilimumab and
pembrolizumab
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Partial Response in both patients
CALM Phase 2 Trial: Activation of RIG-I Pathway and Upregulation of Immune Checkpoint Target Molecules
Day 0 (pre-treatment) Day 8 (post-treatment)
Patient 04-014 Stage IV M1c with melanoma to the leg and lungs. Prior treatment with ipilimumab and
pembrolizumab
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CALM Phase 2 Trial: Results and Future Directions
• Successful study with primary safety endpoint achieved; secondary efficacy endpoint outcomes exceeding expectations
– Overall response rate of 28%
– Durable response in 21% patients
• CAVATAK-induced activity in non-injected distant lesions, including lung and liver metastases
Extension Trial
• Overall response rate of 31%
• CAVATAK-induced changes in the tumor:
– Increases in immune cell infiltrates
– Up-regulation of PD-L1 and other checkpoint molecules
• Observations suggest combination with checkpoint inhibitors may further enhance anti-tumor activity
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CLINICAL TRIAL PROGRESS
Combination Therapy Studies
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CAVATAK ® Combined with Checkpoint Inhibitors
“The world doesn’t need any more [checkpoints]. We need other things. We should be finding a way to develop other medicines beyond these”
Roger Perlmutter, President Research – Merck1
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• Checkpoint inhibitor / CAVATAK combination preclinical results:
– Well tolerated
– Significant anti-tumor activity demonstrated
• CAVATAK combination clinical trials with approved checkpoint inhibitors underway with promising results
• Checkpoint inhibitors active in cancers that are also CAVATAK targets, including melanoma, lung and bladder
• Potential for CAVATAK in combination with future checkpoint inhibitors targeting LAG-3, TIM-3 and other immunotherapies such as IDO (in development by big pharma)
1. Financial Times 3 July 2017
%Su
rviv
al
Time- Control- Conventional Therapy- Checkpoint Inhibitor Therapy (eg anti-CTLA4)- Future Combinations with Checkpoint Inhibitors
Checkpoint Inhibitors: Room to Improve Through Combination with New Therapies
Big Pharma focused on improving activity of the checkpoint inhibitors through combination therapy
Goal: To enhance survival with manageable toxicity through combination with CAVATAK
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CLINICAL TRIAL PROGRESS
MITCI Phase 1b Study
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CAVATAK ® - MITCI Phase 1b StudyMELANOMA INTRA-TUMORAL CAVATAK AND IPILIMUMAB
• Company-sponsored open-label study at 9 US sites evaluating intralesional CAVATAK
and YERVOY®(ipilimumab)
• Primary Objectives are safety and response rate
• Secondary Objectives include PFS, Durable Response Rate and OS
• 60 patients with late-stage melanoma (stage IIIB-C/IV), with a current focus on patients
who have failed a single course of prior pembrolizumab or nivolumab
• Now enrolled 38 patients across all settings
• Lead investigator: Dr Brendan Curti MD, Providence Cancer Center, Portland
• Treatment with CAVATAK on days 1, 3, 5 and 8; both agents co-administered on days
22, 43, 64 and 85, with up to 19 CAVATAK treatments in total
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CAVATAK ® - MITCI Phase 1bBest Percentage Change in Target Lesions
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19Best Overall Response+ (irRC) Per irRCn (%)
Overall response rate 8/14(57%)
Complete response (CR) 3/14 (21%)
Partial response (PR) 5/14 (36%)
Stable disease (SD) 1/14 (7%)
Disease control rate (CR+PR+SD) 9/14 (64%)
* irRC criteria: Preliminary data, investigator assessed+ First response assessment at Day 106± YERVOY® FDA approved label
8 of 14 patients (57%) demonstrated >50% reduction in sum of
target lesions
Preliminary but encouraging results, compared to published YERVOY® alone1 (11%response rate)
Checkpoint therapy naïve (n=14)Overall response rate of 57%
Disease stage
CAVATAK ® - MITCI Phase 1bBest Percentage Change in Target Lesions
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20
Best Overall Response+ (irRC) Per irRCn (%)
Overall response rate 2/7 (29%)
Stable disease (SD) 3/7 (43%)
Disease control rate (CR+PR+SD) 5/7 (72%)
*, irRC criteria: Preliminary data, investigator assessed+, First response assessment at Day 106
2 of 7 patients (29%) demonstrated >50% reduction in sum of
target lesions
Preliminary but encouraging results, compared to published YERVOY®
alone (10-13% response rate)
Prior single line anti-PD-1 therapy (n=7)Overall response rate of 29%
Disease stage
CAVATAK ® - MITCI Phase 1bChange in target lesions sum by disease
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*, irRC criteria: Preliminary data, investigator assessed+, First response assessment at Day 106
Checkpoint therapy naïve (n=14) Single line anti-PD-1 therapy (n=7)
Promising durability in responding patients
CAVATAK ® - MITCI Phase 1bNon-injected Individual Visceral Target Lesion Responses
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Prior anti-PD-1 therapy Checkpoint therapy naïve
• Strong anticancer activity in non-injected liver, visceral and lung lesions
CAVATAK ® - MITCI Phase 1b StudyComplete Tumor Response Stage IIIC (Pt 13-05001*)
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CAVATAK ® - MITCI Phase 1b StudyPartial Tumor Response Stage IV M1c (Pt 13-04005*)
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CAVATAK ® - MITCI Phase 1b Study:Preliminary Results and Outlook
• CAVATAK / YERVOY® combination is well tolerated and has displayed durable antitumour activity in injected and non injected distant systemic disease
• Safety:– No dose-limiting toxicities reported– Six Grade 3+ adverse events in 4 patients (all YERVOY-related: fatigue, elevated liver enzymes
[2], pruritis, dehydration, hyperglycemia) with an overall study Gr 3+ treatment-related AE rate of 11% (4/38 pts)
• Efficacy:– 57% (8/14) Best overall response rate in patients naïve to checkpoint therapy– 29% (2/7) Best overall response rate in patients administered prior single line anti-PD1 therapy – Preliminary but encouraging response rates, versus YERVOY alone (11%*) or other YERVOY
combination studies • Focus on an unmet need in patients who have failed prior anti-PD1 therapy • Plan to enrol 60 patients • Pivotal study in patients with high unmet need that have failed a single anti-PD1 checkpoint therapy (in
planning stage)
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* YERVOY® FDA approved labelPotential to lead to a pivotal study
CLINICAL TRIAL PROGRESS
CAPRA Phase 1b Study
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CAVATAK ® - CAPRA Phase 1b StudyCAVATAK AND PEMBROLIZUMAB in ADVANCED MELANOMA
• Phase 1b company-sponsored open-label study evaluating intralesional CAVATAK and KEYTRUDA® (pembrolizumab)
• Primary objective:– Safety and tolerability
• Secondary objective:– Activity as assessed by PFS at 12 months, ORR, OS, DRR and TTR
• 50 patients with late-stage melanoma (stage IIIB-C/ IV)• Now enrolled 26 patients • Lead investigator: Dr Ann Silk MD, Rutgers Cancer Institute of New
Jersey, New Brunswick• CAVATAK on Days 1, 3, 5 and 8; KEYTRUDA starting on Day 8, both
given at three-weekly intervals for up to 2 years (maximum of 19 CAVATAK injections)
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CAVATAK® - CAPRA Phase 1bBest Overall Response
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Best Overall Response+ (irRC) Per irRCn (%)
Overall response rate 14/23(61%)
Disease control rate (CR+PR+SD) 18/23 (78%)
14 of 23 patients (61%) demonstrated >50% reduction
in sum of target lesions
Disease stage
Overall Response Rate of 61% for CAVATAK® / KEYTRUDA® combination Preliminary but encouraging response rates, versus published KEYTRUDA® alone1 (33%) *Prior ipilimumab treatmentSource: 1FDA approved label data
CAVATAK ® - CAPRA Phase 1bChanges in Tumour Burden by Disease Stage
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Promising durability in responding patients
CAVATAK ® - CAPRA Phase 1b StudyIndividual Patient Responses (investigator assessed)
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Pt1105003Stage IVM1c Partial response
Baseline
Non
-inje
cted
lung
le
sion
upp
er le
ft lo
be
Day 197
Day 113
Pt1106023Stage IIICPartial response
Baseline
Non
-inje
cted
lym
ph n
ode
lesi
on
Righ
t int
erna
l Obt
urat
or re
gion
CAVATAK ® - CAPRA Phase 1bPreliminary Results and Outlook
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• Best Overall Response Rate of 61% (14/23 pts) and DCR of 78% (18/23 pts)
• Tumour responses are ongoing at 12 months in 6 patients
• 4 patients have demonstrated complete responses in the target lesions
• BORR of 64% (7/11 pts) in patients with late stage IV M1c disease
• Reductions in a number of injected and non-injected visceral/non-visceral lesions
• Only two Grade 3 pembrolizumab-related adverse events in 26 enrolled patients
• Preliminary but encouraging response rates compared to KEYTRUDA alone
(33%*) or other KEYTRUDA combination studies
*Robert et al., N Engl J Med 2015; 372:2521-2532
CLINICAL TRIAL PROGRESSKEYNOTE-200 Phase 1 StudyCollaboration with Merck (MSD)
Part A – CAVATAK Monotherapy
Part B – CAVATAK and KEYTRUDA combination
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Multi-Dose Intravenous CAVATAK ®
KEYNOTE-200 Phase 1 Study:
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Cohort 1Any cancer
1 x108 TCID50n=3
18 subjects with advanced melanoma, prostate, NSCLC or bladder cancer with <1:16 anti-CAVATAK serum antibodies
Cohort 31 x 109 TCID50
Mandatory lesion biopsy (Day 8)
Melanoma , NSCLC, BladderAnd Prostate cancer n=3
each
IV infusions of CAVATAK in 100 mL saline over 30 min on Day
1,3,5,22,43,64,85,106,127,158
Cohort 2Any cancer
3 x 108 TCID50n=3
Part A - Completed (CAVATAK Monotherapy)
Cohort 1NSCLC or Bladder cancerCAVATAK (1 x108 TCID50)
+ Keytruda n=3
Cohort 2NSCLC or Bladder cancer
CAVATAK (3 x108 TCID50)+ Keytruda
n=3
Part B – Ongoing (CAVATAK Combination with KEYTRUDA)
Cohort 3:NSCLC or Bladder cancerCAVATAK (1 x109TCID50)
+ Keytrudan=3
IV infusions of CAVATAK in 100 mL saline over 30 min on Day 1,3,5,8,29,50,71,92,113,134,155 + IV pembrolizumab (200mg) every 3 weeks starting Day 8
No Dose Limiting Toxicities
Cohort ExpansionNSCLC (~n=40)CAVATAK(1 x109
TCID50)+ pembrolizumab
Cohort ExpansionBladder (~n=40)CAVATAK(1 x109
TCID50)+ pembrolizumab
No Dose Limiting Toxicities
34Part A - CAVATAK Monotherapy Results Best Change in Target Lesions
*irRECIST criteria: Preliminary data, investigator assessed+First response assessment at Day 42
Ten patients with stable disease
and one patients with a
confirmed partial response
35Part A - CAVATAK Monotherapy Results CAVATAK Tumor Targeting: Biopsy Viral RNA levels (day 8): Cohort 3
CAVATAK RNA present in
melanoma, lung and bladder
cancer tumor tissue following 3
intravenous doses
Well tolerated with no dose
limiting toxicity and no grade 3
or higher treatment related
adverse events
KEYNOTE-200 Phase 1b StudyCAVATAK/ Merck’s KEYTRUDA® Combination
• Phase 1b study in progress; collaboration with Merck (MSD)
• Combination of intravenous CAVATAK / KEYTRUDA in late-stage cancer patients (~ 90 patients)
– Non-small cell lung cancer
– Metastatic bladder cancer
• 17 sites in the US, Australia and UK
• Primary objective: Safety and tolerability
• Secondary objective: Efficacy
• Dose escalation complete with no dose limiting toxicity for the combination of CAVATAK and KEYTRUDA in heavily pre-treated patient population
• Currently 64 subjects enrolled at the top CAVATAK dose level used in the expansion phase
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Potential to lead to a pivotal study
KEYNOTE-200 Phase 1b Study Preliminary First Investigator Assessment in Checkpoint Naïve Patients
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Best percentage change in target lesions of checkpoint naïve patients + *
Encouraging early data in lung and bladder cancer
patients
Well tolerated with 11% (7 of 64 ) patients have
displayed treatment related >grade 3 adverse events
Response observed (not all yet confirmed) in 3 of 10 (30%) NSCLC and 5 of 18 (28%)
metastatic bladder cancer patients *
KEYNOTE-200 Phase 1b Study: Preliminary PD-L1 Expression Levels on Paired Tumour Biopsies
38
Upregulation of PD-L1 in lung and bladder cancer
patients with pre-existing low levels
Preclinical Study – Triple Combination Intravenous CAVATAK and Anti-PD-1 and IDO Inhibitor
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Immune competent mouse melanoma model Significantly reduced tumour burden in mice treated with CAVATAK and anti-PD-1 and the
triplet combination
CLINICAL TRIAL PROGRESS
CANON Phase 1 Study
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CAVATAK ® — CANON Phase 1 Study:(CAVATAK in NON-MUSCLE INVASIVE BLADDER CANCER)
* USA National Cancer Institute, 2016
• NMIBC is a common cancer with high unmet need and no recent
treatment advances
• Standard of care includes toxic chemotherapies
• Study to assess intravesicular CAVATAK in neo-adjuvant, frontline setting:
– Evaluated tolerability, pharmacodynamics
– Evaluated biopsies, blood and urine samples for viral replication
– Documented evidence of anti-tumor activity
• Study complete, 16 patients at Royal Surrey Hospital (UK)
• Intravesicular instillation of CAVATAK in 30 mL saline on Day 1 and/or
Day 2 +/- mitomycin C
• Transurethral resection of tumor tissue at Day 8-11
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Cancer Type
Rank *
Estimated New Cases
in the US in 2016 *
Breast 1st 249,260
Lung 2nd 224,390
Prostate 3rd 180,890
Colorectal 4th 134,490
Bladder 5th 76,960
Melanoma 6th 76,380
42Phase 1 CANON STUDYTumor Response
Surface hemorrhage and elimination of the tumor
Complete clinical response (confirmed by histopathology)
Phase 1 CANON STUDYViral Replication
43
• CAVATAK replication up-regulates target molecules for immune-checkpoint therapies in NMIBC tissue
Phase 1 CANON STUDYUpregulation of Key Checkpoint Molecules
44
Potential to broaden partnering discussions
• Intravesicular administration of CAVATAK well tolerated - no Grade 2, 3 or 4 CAVATAK-related
Adverse Events
• Evidence of tumor targeting with viral replication
• Complete tumor response in one of the first three patients at the highest dose
• CAVATAK induces increases in immune cell infiltrates and expression of PD-L1 compared to
untreated NMIBC controls
• CAVATAK mediates increase in the “immunological heat” within the tumor micro-environment
suggesting potential for enhanced anti-tumor activity when used in combination with immune
checkpoint inhibitors
• Commercial opportunity in neoadjuvant setting - prior to transurethral resection of tumor or in
combination with checkpoint inhibitors
45CAVATAK ® — CANON Phase 1 Study: FINAL Results and Next Steps
CLINICAL TRIAL PROGRESS
New Studies in Planning Stage
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• Phase 1b company-sponsored open-label study evaluating intralesionalCAVATAK and KEYTRUDA® (pembrolizumab)
• To be conducted in the USA
• Primary objective:
– Safety and tolerability
• Secondary objective:
– Activity as assessed by ORR, time to initial response, duration of response
• 24 patients with metastatic stage IV HNSCC for whom systemic treatment with palliative intent is indicated, or subjects with loco-regionally recurrent stage II-IV HNSCC for whom surgical salvage is indicated
• CAVATAK on Days 1, 3, 5 and 8; KEYTRUDA starting on Day 8, both given at three-weekly intervals for up to one year (maximum of 19 CAVATAK injections)
47CAVATAK ® — ITCAHN Phase 1b Study: CAVATAK AND PEMBROLIZUMAB in ADVANCED HEAD & NECK CANCER
• Phase 1b company-sponsored open-label study evaluating intravenousCAVATAK and YERVOY® (ipilimumab)
• To be conducted in the USA
• Primary objective:
– Safety and tolerability
• Secondary objective:
– Activity as assessed by ORR, disease control rate, PFS, DRR
• 6-10 patients with metastatic stage IV uveal melanoma with measurable liver lesions
• CAVATAK on Days 1, 3, 5 and 8, then at three-weekly intervals for a maximum of 11 infusions; both agents co-administered on Days 8, 29, 50 and 71
48CAVATAK ® — CLEVER Phase 1b Study: CAVATAK AND IPILIMUMAB in UVEAL MELANOMA METASTATIC TO LIVER
• Phase 1b company-sponsored open-label study evaluating intravenousCAVATAK and KEYTRUDA® (pembrolizumab)
• To be conducted in the USA • Primary objective:
– Safety and tolerability • Secondary objective:
– Activity as assessed by PFS, PFS hazard ratio, ORR, 1-year survival, overall survival
– PK profile of IV CAVATAK• 15 patients with metastatic stage IIIB-IV melanoma that has progressed
following treatment with an anti-PD-1 inhibitor• CAVATAK on Days 1, 3, 5 and 8, then at three-weekly intervals for a
maximum of 11 infusions; pembrolizumab on Day 8 then every three weeks for up to one year
49CAVATAK ® — PaCKMAN Phase 1b Study: CAVATAK AND PEMBROLIZUMAB in ADVANCED MELANOMA
• Study in planning stage • Phase 1b company-sponsored open-label study evaluating intralesional
CAVATAK and checkpoint inhibitor • Primary objective:
– Safety and tolerability of intralesional CAVATAK administration to liver metastases
• Secondary objective:– Assess the safety of 1, 2 or 3 intralesional CAVATAK injections
• 18-30 patients with colorectal cancer with at least two or more metastatic liver lesions
• CAVATAK delivered as one, two or three weekly intratumoral injections; checkpoint begins 1 week after the last CAVATAK dose then ongoing
50CAVATAK ® —Phase 1b Study: CAVATAK AND CHECKPOINT in COLORECTAL CANCER METASTATIC TO LIVER
SUMMARY
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OVERVIEW - CAVATAK ® Clinical Trial Program
Intratumoral Intravenous Intravesicular
Phase 2: CALM studyAdvanced melanoma
N=57
Phase 2: CALM extension cohort
Advanced melanomaN=13
Phase 1: STORM study (Part A)Melanoma, NSCLC, Bladder and Prostate
cancer N=18
Phase 1: CANON studyNon-muscle invasive bladder cancer
N = 16
CAVATAK®
52
Lung Cancer and Bladder Cancer• STORM Part B / KEYNOTE-200: Merck collaboration – CAVATAK /
KEYTRUDA® Phase 1b study (N=90)Melanoma: • MITCI – CAVATAK / YERVOY® Phase 1b (N=60)• CAPRA – CAVATAK / KEYTRUDA® Phase 1b study (N=50)• PaCKMAN – Intravenous CAVATAK / KEYTRUDA® Phase 1b study (N=15)• CLEVER - Intravenous CAVATAK / YERVOY® in uveal melanoma (N=10)Head and neck/ Colorectal • ITCAHN - CAVATAK / KEYTRUDA® Phase 1b (N=24)• Colorectal cancer – CAVATAK/ checkpoint Phase 1b (planning stage)
Combination Studies
A Strong Record of Achievements
Reported positive interim results CAPRA study Achieved
Reported positive interim results MITCI study Achieved
Identified potential path to market in melanoma in setting of high unmet need Achieved
Sites initiated in US, Australia and UK with strong enrolment in KEYNOTE 200 study Achieved
Pre-clinical work to identify further target indications Achieved
Developed CAVATAK manufacture program Achieved
Well advanced in preparations for clinical studies in new indications Achieved
53
Recognition at Pre-eminent American Cancer Conferences54
Expected News Flow
Initiate CLEVER study in uveal melanoma with intravenous CAVATAK Q4 2017
Initiate ITCAHN study in head and neck cancer with intralesional CAVATAK Q1 2018
Initiate PaCKMAN study in melanoma with intravenous CAVATAK Q1 2018
Provide clinical updates on MITCI / CAPRA trials Q2 2018
Initiate study in colorectal cancer Q2 2018
Report clinical update on KEYNOTE-200 study Q2 2018
Potentially extend intravenous CAVATAK program into new indications Q2 2018
Initiate pivotal melanoma trial Q4 2018
55
CAVATAK ®
A Compelling Commercial Opportunity
• Active in a range of important cancer types with broad potential:
– To combine with a range of checkpoint molecules (eg KEYTRUDA, YERVOY)
– For use in a variety of treatment settings, including intralesional (melanoma, CRC, head and neck), intravenous (melanoma, lung, metastatic bladder) and intravesical (NMIBC)
– Increases immunological heat within the tumor micro-environment
• Well tolerated across all routes of administration
• KEYNOTE-200 – CAVATAK / KEYTRUDA combination in NSCLC and metastatic bladder completed dose escalation and recruiting strongly
• Preliminary results from MITCI (CAVATAK / YERVOY) and CAPRA (CAVATAK / KEYTRUDA) trials very encouraging and point to potential path to market in area of high unmet need
• CANON - Promising results in NMIBC – strong potential in combination with checkpoints
• Aggressive expansion of clinical program planned, with goal of driving partnering discussions and shareholder value
• Recent high value transactions in growing field of cancer immunotherapy
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