Creating and developing innovative therapies. Deborah Rathjen CEO & Managing Director

Transcription

1 Creating and developing innovative therapies Deborah Rathjen CEO & Managing Director

2 Safe Harbor Statement Factors Affecting Future Performance This presentation contains "forward-looking" statements within the meaning of the United States Private Securities Litigation Reform Act of Any statements contained in this presentation that relate to prospective events or developments, including, without limitation, statements made regarding Bionomics development candidates BNC105, BNC210 (IW-2143), BNC101(ET101) and BNC375, its licensing agreements with Ironwood Pharmaceuticals and Merck & Co, its acquisition of Eclipse Therapeutics, drug discovery programs and pending patent applications are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "projects," "forecasts," "will" and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by these forward-looking statements, including risks related to our available funds or existing funding arrangements, a downturn in our customers' markets, our failure to introduce new products or technologies in a timely manner, regulatory changes, risks related to our international operations, our inability to integrate acquired businesses and technologies into our existing business and to our competitive advantages, as well as other factors. Results of studies performed on competitors products may vary from those reported when tested in different settings. Subject to the requirements of any applicable legislation or the listing rules of any stock exchange on which our securities are quoted, we disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this presentation. 2

3 Bionomics Snapshot KEY STATISTICS (July 2013) 6 MONTH SHARE PRICE PERFORMANCE ASX code Share price (26/7/13) BNO A$ week high A$ week low A$0.245 Shares on issue 411.1M Market capitalisation Cash 30/6/13 A$164M A$22.5M BOARD Graeme Kaufman Chairman MANAGEMENT Deborah Rathjen CEO & MD Deborah Rathjen CEO & MD Trevor Tappenden Non-exec Director José Iglesias CMO Errol DeSouza Non-exec Director Melanie Young CFO & Company Secretary Jonathan Lim Non-exec Director 3

4 Bionomics Investment Highlights Emerging biotech with global operations in Australia (ASX:BNO), Europe and the United States World class discovery and development capabilities targeting multi-billion dollar market opportunities in solid tumour oncology, CNS, and immune diseases Broad and deep portfolio of clinical and preclinical drug candidates supported by proprietary technology platforms: BNC105 solid tumour targeting agent in Phase II trials for renal and ovarian cancer with key data in early 2014 BNC210 (IW-2143) targeting anxiety and depression partnered with Ironwood Pharmaceuticals US$345 million in upfront, research and milestone payments, plus royalties BNC101 and other Cancer Stem Cell (CSC) targeting antibodies from the acquisition of Eclipse Therapeutics; BNC101 entering clinic in 2014 Nav1.7 program targeting chronic and neuropathic pain partnered with Merck & Co (MSD) US$172 million in option exercise fees, development and regulatory milestone payments, plus royalties Partnerable Kv1.3 program and BNC375 drug candidate anticipated to generate additional value inflection points in CY2013 Strategy to partner our compounds at key value points to crystallise value, improve rate of success and manage risk 4

5 Bionomics Business Model Partnering is key to managing execution risk, validating our compounds and ensuring our compounds reach their markets Drug Discovery Drug Development Partnering Platform for delivering new drug candidates Propagates pipeline with multiple shots on goal Targeted clinical trials Lay off risk with experienced partners Generate revenue streams to support discovery programs 5

6 Drug Candidate Portfolio Leverages Core Strengths CORE STRENGTHS DRUG CANDIDATE/PROGRAM DISCOVERY PRE- CLINICAL PHASE I PHASE II LICENSEE/ PARTNER BNC105 Solid Tumours, renal, ovarian, mesothelioma CANCER BNC101 Cancer stem cells, Solid Tumours, colon, breast, pancreatic BNC102 Cancer stem cells, Solid Tumours VEGFR3 Solid Tumours, melanoma, breast RET lung and thyroid Cancers BNC210 (IW-2143) Anxiety/Depression CENTRAL NERVOUS SYSTEM BNC375 Cognitive impairment, Alzheimer's Disease, ADHD, schizophrenia GABA-A Epilepsy NaV1.7 - Pain IMMUNE DISEASE Kv1.3 Psoriasis, Multiple Sclerosis, Rheumatoid Arthritis Targeted licensing point 6

7 Nav 1.7: $172M Pain Partnership with Merck & Co Deal further validates ionx & MultiCore drug discovery platforms Value creation through strategic partnering business model Future success-based revenue streams & royalties secured COMMERCIAL ELEMENTS THERAPEUTIC AREA Option and license agreement with Merck & Co US$172m in option exercise fees, development/regulatory milestone payments, plus royalties Treatment of chronic pain, including neuropathic pain MARKET SIZE & POSITIONING Pain Market totalled US$22 billion in sales in 2010 Neuropathic pain segment of market expected to grow from US$2.4 billion in 2010 to US$3.6 billion by 2020 Current medications have limited effectiveness: estimated only 1 in 4 patients with neuropathic pain achieve >50% reduction in pain levels side-effects include drowziness, somnolence and dizziness VALIDATION Nav1.7 as a target has been validated through genetic studies 7

8 BNC210 (IW-2143): A next generation compound with potential in the treatment of anxiety and depression TREATMENT MODE OF ACTION CLINICAL BENEFITS MARKETS Anxiety and Depression Modulates novel pathway, to promote anti-anxiety activity and neurite outgrowth in vitro. Four Phase I trials completed, including a trial assessing panic attack symptoms: 59 subjects enrolled in double-blinded placebo controlled trial;15 subjects classified as having a panic attack upon CCK-4 administration Statistically significant decrease in both number & intensity of symptoms (p<0.05) BNC210 treated subjects returned to normal emotional status within 10 minutes, compared to 60 minutes on placebo This trend correlated with the statistically significant reduction in panic symptoms by BNC210 BNC210 has been administered to 108 healthy subjects to date with excellent safety profile BNC210-related changes in human brain activity indicative of efficacy Reduced panic symptoms No evidence of sedation or addiction to date Anxiety global sales of US$5-7bn annually Depression global sales US$11bn Partnered with Ironwood (NASDAQ:IRWD) US$345 million in upfront, research and milestone payments, plus royalties 8

9 BNC210 (IW-2143): Fewer side-effects expected to be a key product differentiator COMPETITIVE ADVANTAGES OF BNC210* DRUG NO SEDATION NO WITHDRAWAL SYNDROME NO MEMORY IMPAIRMENT FAST ACTING NO DRUG/DRUG INTERACTIONS ONCE-A- DAY DOSING BNC210 VALIUM PROZAC BUSPAR * Based on preclinical data and results of Phase I trial comparing BNC210 with Lorazepam 9

10 BNC375: More than Alzheimer s Disease 7 NAChR receptor activation improves attention, working memory and recognition memory Following late-stage development failures by drugs targeting β- amyloid (Lilly, Pfizer, J&J), 7 NAChR approaches have come to the forefront; Pharma hungry for AD drugs Market opportunity for drugs modulating 7 NAChR activity includes many neurodegenerative and psychiatric disorders: Alzheimer s Disease (AD), Parkinson s Disease, Schizophrenia, ADHD and mood and anxiety disorders Prevalence Estimated Global sales Alzheimer s Disease Cognitive Dysfunction in Schizophrenia 9.7 Million $10.2 Billion (2012) 3.4 Million No approved products ADHD 44.9 Million $4.9 Billion Parkinson s Disease 7.0 Million $3.5 Billion 10

11 BNC375: Competitive advantages* Bionomics Competing Characteristics BNC375 Agents+ Potent Rapid onset of action Potentiates endogenous receptor ligand Preserve the normal signalling patterns of the receptor Do not cause receptor desensitization No potential for development of tolerance Selectivity over other nicotinic receptors *Based on data from preclinical animal studies +Published information and Bionomics in-house data 11

12 BNC105: Best in Class vascular targeting agent with unique dual mechanism of action TREATMENT Solid Cancers: New paradigm with blockbuster potential through rational combination with molecular targeted therapies that benefit from induction of tumour hypoxia The current market size in treatment of all solid tumours is >US$10b (Avastin, Genentech/Roche sales >US$5b in 2011) MARKETS Renal cancer market size >US$2.5bn; include TKI Sutent, Pfizer; Nexavar, Bayer/Onyx; Afinitor, Novartis Ovarian cancer market size US$2.2bn in 2011 CLINCAL Phase II Renal cell cancer (US, Australia, Singapore) Trial design: randomized 2-arm; Afinitor+/- BNC105; enrolment of 139 patients completed; patients previously failed TKI therapy; Primary endpoint 6 month PFS; data anticipated 2H, 2013 Phase I results: combination BNC105 + Afinitor safe and well tolerated; 12 patients enrolled across 4 BNC105 dose levels (4-16mg/m 2 ); 8 patients achieved stable disease; 1 patient still on study having received 24 treatment cycles (72 weeks, 18 months) Phase II Mesothelioma (Australia): single arm; BNC105 following Alimta + cisplatin failure; 30 patients enrolled; 1 patient with durable & sustained partial response with corresponding reduction in mesothelin levels; 13 patients with stable disease Phase I/II Ovarian cancer (Australia, New Zealand, US) Phase I enrolment completed; carboplatin and gemcitabine +/- BNC105; population partially sensitive to platinum-based therapy Dual Action selectively targets both tumour blood vessels and cancer cells BENEFITS Rapid, Potent Action works rapidly to shut down tumour blood vessels, potent antitumour action as a single agent, tumour less likely to escape treatment Enhances Effectiveness of Other Cancer Treatments delivers synergistic anti-cancer effects in numerous combinations (e.g., anti-vegf) 12

13 BNC105: Targeting solid tumours By selectively shutting down tumour blood vessels, BNC105 rapidly inhibits tumour growth untreated BNC105 treated 13

14 BNC105: Renal Cancer Phase II Trial Enrolment now complete 139 patients On pathway to partnership Right Kidney Tumour Burden Potential to be a new treatment paradigm for patients with renal cancer Encouraging initial results from US renal cancer trial Combination of Afinitor & BNC105 safe & well tolerated As effective as Sutent in reducing tumour size in animal model Sutent (Pfizer) is the current market leader with 2010 global sales US$1b Globally, Renal Cancer is 7 th most common form of cancer resulting in over 100,000 deaths p.a. 14

15 Cancer Stem Cell Therapeutics The missing link in treating solid tumours CSCs are resistant to conventional therapies Eradicating CSCs may prevent tumour recurrence Complements the BNC105 program by targeting the seeds of cancer 15

16 BNC101: Targeting cancer stem cells in solid tumours TREATMENT Solid tumours; colon, breast, pancreatic MOA Humanised monoclonal antibody MARKETS BNC101 binds selectively to LGR5; LGR5 marks tumour-initiating cells in colon and gastric cancer LGR5 is highly overexpressed in colon, ovarian, liver, breast, lung and other solid tumours Ligand: R-spondin, forms part of LGR5 LRP6 Wnt Fzd signaling complex High expression of LGR5 in colon cancer has been linked to tumour recurrence and poor prognosis Market for cancer stem cell therapeutics has been estimated to be a $8B market opportunity by 2018 DEVELOPMENT STAGE BENEFITS Late preclinical; GMP manufacture by Lonza; IND enabling studies commenced in US; Anticipated IND filing 2014 First-in-class therapeutic antibody against validated CSC target Specific targeting of cancer stem cells 16

17 Market Opportunity: CSCs Next Significant Advance in Cancer Treatment Company Technology Financials OncoMed CSC antibodies targeting cancer gene/signalling pathways (Wnt & Notch) Strong preclinical trial results Clinical trials ongoing Strategic alliance: Bayer Total: >$1,975M Upfront: $40M Strategic alliance: GSK Total:>$1,400M Upfront: undisclosed Stemline Therapeutics Discovery Platform Phase I/II clinical trials Verastem Screening platform CSC-like cells Preclinical Wnt program Clinical focal adhesion kinase (FAK) program Boston Biomedical Roche (Arius) Advanced clinical development programs (Phase I, II, planning Phase III) IPO July 2013, raised $85M, priced $17 per share, market cap $500M IPO Jan 2013 (NASDAQ:STML) Market cap $330M IPO 2012 (NASDAQ:VYST) Market cap~$330m Acquired by Dainippon for >$2.6B in 2012 ($200M upfront) Pre-IND anti-cd44 antibody Acquired for $184M cash by Roche 17

18 R&D Outlook & Anticipated Milestones: Partnership Focus Key Program Milestone Anticipated Timing (CY) BNC105: All Solid Tumours Complete Phase II renal cancer trial enrolment 1H, 2013 Results from renal cancer trial 1Q, 2014 Complete ovarian Phase I trial enrolment New data presentations at AACR, ASCO-GU & ASCO 1H,2013 1H, 2013 BNC101(formerly ET101): Cancer Stem Cells Initiation of IND enabling studies & GMP manufacture 1H, 2013 BNC375/Alpha 7: Alzheimer s Disease/Cognitive Enhancement Drug candidate selection 2H, 2012 Initiation of IND enabling studies & GMP manufacture 1H, 2013 Kv1.3: Autoimmune Disease Partnership 2013 Nav1.7 partnership with Merck & Co potential for up to US$172 million in option fees, regulatory and development milestones, plus royalties 18

19 BNO Investment Proposition Bionomics has world class discovery & development capabilities targeting multi-billion dollar market opportunities in cancer, CNS & immune diseases Bionomics technology platforms deliver diversified product pipeline, while corporate partnering manages execution risk Clinical trial success of BNC105 in renal cancer should lead to a lucrative licensing transaction Licensing of anxiety drug BNC210 to Ironwood has potential to deliver significant shareholder returns via milestone payments and royalties Latest partnership with Merck & Co (MSD) further demonstrates Bionomics business model Advancing range of additional pipeline drug candidates including BNC375 Alzheimer s candidate & Kv1.3 program with strong partnering potential Acquisition of Eclipse Therapeutics (now Bionomics Inc) has positioned BNO as a leading player in cancer stem cells, adding high value antibody therapeutics & a US platform Bionomics well positioned to execute its plan to build sustainable revenue streams from multiple drug candidates 19

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