At the forefront of cancer immunotherapy. Investor Presentation January 2018

Transcription

1 1 At the forefront of cancer immunotherapy Investor Presentation January 2018

2 Investment highlights Lead investigational product CAVATAK kills cancer cells with a bio-selected form of the common cold virus Excellent preliminary results, three ongoing clinical trials, >250 patients have received CAVATAK Used in combination to enhance existing blockbuster drugs Market-leading body of clinical evidence, multiple target areas, excellent safety profile Global support from big pharma, leading healthcare investors and key opinion leaders Multiple value inflection points including near-term milestones page 2

3 Viralytics at a potential value inflection point, with multiple pathways to realise value of CAVATAK Primary commercial focus Discovery Demonstrate efficacy Maximise asset value A bio-selected strain of the common cold virus (CAVATAK ) was found to be effective in killing cancer cells in preclinical studies Clinical trials demonstrate effectiveness standalone, and in combination with other immunotherapy drugs Preliminary focus was on melanoma via intratumoural administration Program expansion to intravenous administration, and multiple high-need target areas, to demonstrate broad applicability of CAVATAK Broad applicability expected to lead to increased market potential, and increase in number of potential pharma partners Viralytics to progress the most advanced opportunities to a potential pivotal study page 3

4 Viralytics is making excellent progress in the exciting sector of cancer immunotherapy TRADITIONAL TREATMENTS such as chemotherapy and radiotherapy haven t changed much since the 1950 s IMMUNOTHERAPY is cutting edge, and uses the body s own immune system to kill cancer cells RAPID MARKET SHARE GROWTH Immunotherapy expected to grow to 50% of the total cancer treatment market by HOT SECTOR FOR M&A $16.6b immuno-oncology deal value 2, greater than all other oncology combined 1: IMS Health 2: Defined Health Insight series 2016 page 4

5 Our lead drug CAVATAK is a bio-selected form of the common cold virus that kills cancer cells Intravenous CAVATAK is released from tumour, and the process repeats Intratumoural Intravesical Binds externally to tumour cell Infects cancer cell Replicates and destroys cell Stimulates patient s own immune response against the cancer throughout the body ADMINISTRATION Multiple routes maximise applicability CAVATAK kills cancer cells and stimulates the patient s immune response page 5

6 % Survival CAVATAK is at the forefront of combination therapies, the future of cancer treatment Combination immunotherapies aim to dramatically improve cancer survival rates over time Big Pharma is racing to find the most effective combinations 100 Combination immunotherapy CURRENT GOAL Combination therapies (e.g. Viralytics CAVATAK in combination with Checkpoint Inhibitors) Standalone immunotherapy Chemotherapy, radiotherapy RECENT ADVANCES Checkpoint inhibitors the first immunotherapies to achieve FDA approval STANDARD OF CARE (SINCE THE 1950 S) 0 Time Chemotherapy / radiotherapy There is a lot of room to improve if we do come up with the right combination. That s the future. We are only at chapter one in the book of immunotherapy. Dr. Israel Lowy, Vice-president, Regeneron (leading Biotechnology company) Note: Graphic shown is not to scale, for illustrative purposes only page 6

7 CAVATAK in combination with checkpoint inhibitors has the potential to be the new standard of care CAVATAK is an oncolytic virus that is a bio-selected form of the common cold and kills cancer cells CAVATAK is not genetically modified and we believe has the differentiation of allowing multiple routes of administration (intravenous, intratumoural and intravesical). We believe this opens up a much broader opportunity for the product in multiple tumour types. Roth Capital Checkpoint inhibitors are at the forefront of immunotherapy. Over ~$6b of sales in 2016 Big-pharma have checkpoint inhibitors in the market, including: What is a checkpoint inhibitor? Why are we combining with them? Checkpoint inhibitors are antibodies that stimulate the immune system to attack cancer cells. CAVATAK can heat tumours, making them a more attractive and easier target for checkpoint inhibitors so they can be more effective at fighting cancer. page 7

8 Encouraging early results from ongoing clinical trials Data shown is preliminary, based on ongoing single-arm Phase 1 trials. CAVATAK is an investigational drug CAVATAK with KEYTRUDA (CAPRA trial) compared to published KEYTRUDA data CAVATAK with YERVOY (MITCI trial) compared to published YERVOY data Response rates in patients with advanced melanoma: KEYTRUDA + CAVATAK YERVOY + CAVATAK Data source Published data (FDA approved label) Ongoing clinical trials (single-arm) 1 Published data (FDA approved label) Ongoing clinical trials (single-arm) 1 Key information KEYTRUDA owned by ~$6b sales in Trial name: CAPRA Preliminary but encouraging response rates, versus published KEYTRUDA alone 4 YERVOY owned by ~$1.5b sales in Trial name: MITCI Preliminary but encouraging response rates, versus published YERVOY alone 4 1. Response rates shown are preliminary and based on in-progress Phase 1b clinical studies 2. Merck is known as MSD outside USA and Canada 3. Evaluate EP Vantage 2018 Preview 4. Bloomberg average via FiercePharma page 8

9 CAVATAK has received capital markets validation, with strong institutional investor support Key Statistics Ticker Code Share Price (as at 5-Jan-18) Market Capitalisation (as at 5-Jan-18) Trading Range (12-month) Institutional and Pharma investors ASX: VLA OTCQX: VRACY A$0.82 A$226M A$ % Cash position (31 Dec 17 pro forma) 1 A$57M Net operating cash burn (Calendar 2017) A$16.4M 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 1 Includes $29.6 million investment and $6.4 million R&D tax incentive received since 31 December. page 9

10 CAVATAK has received scientific validation, with podium positions at leading conferences The world's oldest and largest professional association related to cancer research Leading cancer research meeting, attended by oncology experts from around the world World s leading member driven organisation specifically dedicated to cancer immunotherapy page 10

11 Multiple CAVATAK target areas maximise potential value, partnerships and paths to commercialisation Initial focus Current focus, to demonstrate broad applicability of CAVATAK in common cancer types New high potential focus areas MELANOMA LUNG BLADDER COLORECTAL HEAD & NECK 6 th most common cancer 2 nd most common cancer 5 th most common cancer 4 th most common cancer Broad range of cancers Clinical trials completed Further underway Clinical trial underway Clinical trial underway Clinical trial in planning Clinical trial in planning Pivotal trial protocol in development Source: USA National Cancer Institute, 2016 page 11

12 Viralytics is building a market leading body of clinical evidence on CAVATAK Program Combination drug 1 Target Progress Pre-clinical Phase I Phase II Highlights CAPRA KEYTRUDA Melanoma Phase Ib 26/50 patients enrolled Well tolerated with encouraging initial efficacy data: 61% best overall response rate (Published KEYTRUDA alone 3 is 33%) MITCI YERVOY Melanoma Phase Ib 38/60 patients enrolled Well tolerated with encouraging initial efficacy data: 57% best overall response rate (Published YERVOY alone 3 is 11%) KEYNOTE- 200 KEYTRUDA Lung, bladder Phase Ib 64/90 patients enrolled Part A (CAVATAK alone) completed successfully, Part B underway in collaboration with Merck 2 ; encouraging initial positive signals of activity CALM NA - standalone Melanoma Phase II COMPLETE, 70 patients Efficacy exceeded expectations with overall response rate of 28% in advanced disease patients. CANON Mitomycin (chemotherapy) Bladder cancer Phase I COMPLETE, 16 patients CAVATAK was well tolerated with promising results underpinning strong potential in combination with checkpoints 1. In combination with CAVATAK 2. Merck known as MSD outside USA and Canada 3. FDA approved label data page 12

13 CAPRA Phase 1b Encouraging positive outcomes in melanoma patients TRIAL OVERVIEW Target area Administration Melanoma Intratumoural Progress 26 out of 50 patients enrolled Combination Lead investigator CAVATAK and KEYTRUDA - single arm trial Dr Ann Silk MD, Rutgers Institute of New Jersey Upcoming milestones Clinical updates in Q CLINICAL RESULTS 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 Best Overall Response Rate 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 Note: Summary information only see Viralytics website for further details page 13

14 CAPRA Phase 1b Encouraging preliminary response rates for CAVATAK + KEYTRUDA combination Best percentage change in target lesions irrc criteria (Preliminary data, investigator assessed) 14 of 23 patients (61%) demonstrated >50% reduction in sum of target lesions Disease stage Each bar represents 1 patient Overall Response Rate of 61% for CAVATAK / KEYTRUDA combination Preliminary but encouraging response rates, versus published KEYTRUDA alone 1 (33%) *Prior ipilimumab treatment Source: 1 FDA approved label data page 14

15 CAPRA Phase 1b Impressive Evidence of Reduction in Target Lesions Baseline Day 197 Stage IVM1c Partial response Non-injected lung lesion upper left lobe Baseline Day 113 Stage IIIC Partial response Non-injected lymph node lesion Right internal Obturator region page 15

16 MITCI Phase 1b Encouraging positive outcomes in melanoma patients TRIAL OVERVIEW Target area Administration Melanoma Intratumoural Progress 38 out of 60 patients enrolled Combination Lead investigator CAVATAK and YERVOY - single arm trial Dr Brendan Curti MD, Providence Cancer Center, Portland Upcoming milestones Clinical updates in Q CLINICAL RESULTS Safety: No dose-limiting toxicities reported Six Grade 3+ adverse events in 4 patients (all YERVOY-related: fatigue, elevated liver enzymes [2], pruritis, dehydration, hyperglycaemia) 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 published YERVOY alone 1 (11%) Note: Summary information only see Viralytics website for further details Source: 1 FDA approved label data page 16

17 Best percentage change in the sum of target lesions cross product relative to baseline irrc Best percentage change in sum of target lesions cross product relative to baseline irrc MITCI Phase 1b Encouraging preliminary response rates for CAVATAK + YERVOY combination Checkpoint therapy naïve (n=14) Overall response rate of 57% Prior single line anti-pd-1 therapy (n=7) 17 Overall response rate of 29% Disease stage IIIC IVM1a IVM1b IVM1c Disease stage IIIC IVM1a IVM1b IVM1c of 14 patients (57%) -100 demonstrated >50% reduction in sum of target lesions of 7 patients (29%) demonstrated >50% reduction in sum of target lesions Each bar represents 1 patient Each bar represents 1 patient Preliminary but encouraging results, compared to published YERVOY alone 1 (11% response rate) * irrc criteria: Preliminary data, investigator assessed + First response assessment at Day FDA approved label data page 17

18 MITCI Phase 1b Impressive Evidence of Reduction in Target Lesions in patients with advanced melanoma MITCI Phase 1b Pre-treatment Day 90 Day 180 Complete response demonstrated Prior treatments include BCG and Nivolumab MITCI Phase 1b Partial response demonstrated Pre-treatment Day 127 Day 310 Prior treatments include Ipilimumab/Nivolumab, Nivolumab, Surgery page 18

19 KEYNOTE-200 Phase 1b Exciting trial in collaboration with Merck, in high-potential target areas (lung and bladder) TRIAL OVERVIEW Target area Administration Non-small cell lung cancer (NSCLC), Bladder cancer Intravenous Progress 64/90 patients. 17 sites in US, UK & Aus. recruiting Combination Lead sites CAVATAK and KEYTRUDA - single arm trial Memorial Sloan Kettering (USA), Royal Surrey County Hospital (UK) Upcoming milestones Clinical updates in Q WHY IS THE KEYNOTE-200 TRIAL SO IMPORTANT? KEYNOTE-200 tackles two of the five most common cancer types in the US Lung and Bladder Efficacy via intravenous administration would massively broaden the possible market and potential pharma partners for CAVATAK CLINICAL RESULTS Similar adverse event profile when compared to KEYTRUDA alone Of 28 evaluable patients, response observed (not all yet confirmed) in 3 of 10 (30%) NSCLC and 5 of 18 (28%) metastatic bladder cancer patients. 12 of these 28 patients currently remain on the study Note: Merck known as MSD outside of USA and Canada page 19

20 KEYNOTE-200 Phase 1b Encouraging data + in lung and bladder cancer patients treated with CAVATAK + KEYTRUDA Response observed (not all yet confirmed) in 3 of 10 (30%) NSCLC and 5 of 18 (28%) metastatic bladder cancer patients * Each bar represents 1 patient page 20

21 Key players are acquiring immunotherapy companies in a similar development stage to Viralytics As a leading innovator in the field of immuno-oncology, Merck is dedicated to advancing breakthrough science Eric Rubin, MD Oncology Early-stage Combination therapy will be foundational to delivering the potential for long term survival for patients Francis Cuss, Chief Scientific Officer 2017 Acquisition US$554m Phase I/II 2017 License US$2.8bn Phase I/II and below 2016 Acquisition US$400m Pre-clinical 2016 Acquisition US$1.7bn Phase II 2016 License US$200m Pre-clinical 2016 Acquisition US$400m Pre-clinical Note: Merck known as MSD outside of USA and Canada page 21

22 Viralytics has enviable optionality, with multiple value realisation pathways Continue to progress clinical development, to achieve value inflection of CAVATAK DEVELOP INDEPENDENTLY PARTNER WITH BIG PHARMA Realise value via licensing and milestone revenues Recognise equity upside potential through M&A LICENSE A TARGET AREA SALE OF COMPANY Viralytics is actively pursuing the most value-accretive pathways page 22

23 Viralytics has three main clinical goals for Progress melanoma programme into a pivotal study RELEVANT CLINICAL TRIAL: MITCI 2. 2 Demonstrate large addressable market through intravenous use of CAVATAK in very large indications: lung and bladder cancer RELEVANT CLINICAL TRIAL: KEYNOTE Highlight broad potential through signal seeking studies in head and neck cancer, colorectal cancer and ocular melanoma FOUR NEW STUDIES TO BE INITIATED IN 2018 page 23

24 Disclaimer Certain statements made in this presentation are forward looking statements within the meaning of the safe harbour provisions of the United States Private Securities Litigation Reform Act of These forward looking statements are not historical facts but rather are based on Viralytics current expectations, estimates, assumptions and projections about the industry 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 should be considered an at-risk statement. These forward looking statements are not a guarantee of future performance and involve known and unknown risks and uncertainties, some of which are beyond the control of Viralytics or which are difficult to predict, which could cause the actual results, performance or achievements of Viralytics to be materially different from those which may be expressed or implied by these statements. These statements are based on our management s current expectations and are subject to a number of uncertainties and risks that could change the results described in the forward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition, general economic factors, the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally, and challenges inherent in new product development. Investors should be aware that there are no assurances that results will not differ from those projected and Viralytics cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of Viralytics only as of the date of this presentation. Viralytics is not under a duty to update any forward-looking statement as a result of new information, future events or otherwise, except as required by law or by any appropriate regulatory authority. page 24