Creating and developing innovative therapies
Deborah RathjenCEO & Managing Director
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Safe Harbor Statement
Factors Affecting Future PerformanceThis presentation contains "forward-looking" statements within the meaning of the United States’ Private Securities Litigation Reform Act of 1995. 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.
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Bionomics Snapshot
KEY STATISTICS (July 2013)
ASX code BNO
Share price (26/7/13) A$0.40
52 week high A$0.455
52 week low A$0.245
Shares on issue 411.1M
Market capitalisation A$164M
Cash 30/6/13 A$22.5M
MANAGEMENT
Deborah Rathjen CEO & MD
José Iglesias CMO
Melanie Young CFO & Company Secretary
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BOARD
Graeme Kaufman Chairman
Deborah Rathjen CEO & MD
Trevor Tappenden Non-exec Director
Errol DeSouza Non-exec Director
Jonathan Lim Non-exec Director
6 MONTH SHARE PRICE PERFORMANCE
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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
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Bionomics Investment HighlightsF
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Bionomics Business Model
Partnering is key to managing execution risk, validating our compounds and ensuring our
compounds reach their markets
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Drug Discovery
Drug Development Partnering
• Lay off risk with experienced partners
• Generate revenue streams to support discovery programs
• Platform for delivering new drug candidates
• Propagates pipeline with multiple shots on goal
• Targeted clinical trials
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DRUG CANDIDATE/PROGRAM DISCOVERY PRE-CLINICAL PHASE I PHASE II LICENSEE/
PARTNER
CANCER
BNC105 – Solid Tumours, renal, ovarian, mesothelioma
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
CENTRALNERVOUSSYSTEM
BNC210 (IW-2143) – Anxiety/Depression
BNC375 – Cognitive impairment, Alzheimer's Disease, ADHD, schizophrenia
GABA-A – Epilepsy
NaV1.7 - Pain
IMMUNE DISEASE
Kv1.3 –Psoriasis, Multiple Sclerosis, Rheumatoid Arthritis
Drug Candidate Portfolio Leverages Core Strengths
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CORE STRENGTHS
Targeted licensing point
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Nav 1.7: $172M Pain Partnership with Merck & Co
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COMMERCIAL ELEMENTS
Option and license agreement with Merck & Co US$172m in option exercise fees, development/regulatory milestone
payments, plus royalties
THERAPEUTIC AREA 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
Deal further validates ionX & MultiCore drug discovery platforms Value creation through strategic partnering business model Future success-based revenue streams & royalties secured
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BNC210 (IW-2143): A next generation compound with potential in the treatment of anxiety and depression
TREATMENT Anxiety and Depression
MODE OF ACTION
Modulates novel pathway, to promote anti-anxiety activity and neuriteoutgrowth in vitro.
CLINICAL
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
BENEFITS BNC210-related changes in human brain activity indicative of efficacy Reduced panic symptoms No evidence of sedation or addiction to date
MARKETS
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
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COMPETITIVE ADVANTAGES OF BNC210*
DRUG NO SEDATION
NO WITHDRAWAL
SYNDROMENO 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
BNC210 (IW-2143): Fewer side-effects expected to be a key product differentiator
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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
9.7 Million $10.2 Billion (2012)
Cognitive Dysfunction in Schizophrenia
3.4 Million No approved products
ADHD 44.9 Million $4.9 Billion
Parkinson’s Disease
7.0 Million $3.5 Billion
BNC375: More than Alzheimer’s Disease
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BNC375: Competitive advantages*
CharacteristicsBionomicsBNC375
CompetingAgents+
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
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*Based on data from preclinical animal studies+Published information and Bionomics’ in-house data
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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
MARKETS
The current market size in treatment of all solid tumours is >US$10b (Avastin, Genentech/Roche sales >US$5b in 2011)
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/m2); 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
BENEFITS
Dual Action – selectively targets both tumour blood vessels and cancer cells
Rapid, Potent Action – works rapidly to shut down tumour blood vessels, potent anti-tumour 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)
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BNC105treateduntreated
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By selectively shutting down tumour blood vessels, BNC105 rapidly inhibits tumour growth
BNC105: Targeting solid tumours F
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BNC105: Renal Cancer
Phase II Trial Enrolment now complete 139 patients On pathway to partnership
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
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Right Kidney Tumour Burden
Globally, Renal Cancer is 7thmost common form of cancer resulting in over 100,000 deaths p.a.
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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
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BNC101: Targeting cancer stem cells in solid tumours
TREATMENT Solid tumours; colon, breast, pancreaticMOA Humanised monoclonal antibody
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
MARKETS Market for cancer stem cell therapeutics has been estimated to be a $8B market opportunity by 2018
DEVELOPMENT STAGE
Late preclinical; GMP manufacture by Lonza; IND enabling studies commenced in US; Anticipated IND filing 2014
BENEFITS First-in-class therapeutic antibody against validated CSC targetSpecific targeting of cancer stem cells
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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
IPO July 2013, raised $85M, priced $17 per share, market cap $500M
StemlineTherapeutics
Discovery Platform Phase I/II clinical trials
IPO Jan 2013 (NASDAQ:STML)
Market cap $330M
Verastem Screening platform CSC-like cells Preclinical Wnt program Clinical focal adhesion kinase (FAK) program
IPO 2012 (NASDAQ:VYST) Market cap~$330M
Boston Biomedical
Advanced clinical development programs (Phase I, II, planning Phase III)
Acquired by Dainippon for >$2.6B in 2012 ($200M upfront)
Roche(Arius)
Pre-IND anti-CD44 antibody Acquired for $184M cash by Roche
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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, 2013Results from renal cancer trial 1Q, 2014
Complete ovarian Phase I trial enrolment 1H,2013New data presentations at AACR, ASCO-GU & ASCO 1H, 2013BNC101(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
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Nav1.7 partnership with Merck & Co ‐ potential for up to US$172 million in option fees, regulatory and development milestones, plus royalties
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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
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