Investor Update - September 2009 by shuifanglj

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									Investor Update - September
2009
Chris Fullerton - Non-executive Director
 ebo a     at je   C O     a ag g      ecto
Deborah Rathjen - CEO & Managing Director
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 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, its drug discovery programs and pending patent
       li ti
  applications are d       d to be f     d l ki
                    deemed t b forward-looking statements. W d such as "believes,"
                                                     t t      t Words       h    "b li   "
  "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
   i k     l t dt          il bl f d         i ti
  risks related to our available funds or existing funding arrangements, a downturn in
                                                   f di                  t    d    t   i
  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
                                    presentation.
  occurring after the date of this presentation


                                                                                         2
 Investment Fundamentals

Top Tier Management    • Track record of successful
                                 i li  i     d      l di
                       commercialisation and concluding
                       commercial deals
Strong Drug Pipeline   • Two competitive compounds in clinical
                       trials focused on cancer (Ph II) and CNS
                       (Ph I) diseases
Strong Platform        • Proprietary drug discovery platform to
                       support future pipeline
Validation of          • Partnership with Merck Serono – up to
Technology             US47M per compound + royalties, R&D
                           y        (     p            )
                       fully funded (Multiple Sclerosis)
Revenue Generation     • Profitable subsidiary in Europe
Strong Commercial      • Retain upside of licensed targets and
 ea s
Deals                  d ag ost c
                       diagnostic tests


                                                                  3
  Bionomics Pipeline Overview

                 PROJECT       DISCOVERY   PRECLINICAL   IND ENABLING       CLINICAL



               BNC105

Cancer                                                          Phase II
                BNO69                                              2009


Immune          Kv1.3
              Inhibitors
                                                   Partnered with
Disease                                            Merck Serono
          Multiple Sclerosis

              BNC210
Central
              Anxiety
Nervous                                                      Phase I
              GABA-A
                                                               2009
System
S t          agonists
             Epilepsy                                                   4
BNC105

• Powerful vascular disrupting agent (VDA)
• Shuts down cancer blood vessels -does not shut down normal
  blood vessels
• Next generation treatment for cancer – June 2008 BNC105 voted
    p                  g y        p
  Top 5 new cancer drugs by Thompson Pharma
• Estimated market for VDAs is US$5 billion pa   (ASInsights 2003)




    Breast tumour                 Breast tumour + BNC105
                                                                     5
BNC105: Strong Competitive
Advantages
 d a ag
• Potent VDA - exhibits single agent efficacy with 20% clearance
  rate
• Highly selective for activated endothelium – no effects on normal
  vasculature
• Dual action - directly cytotoxic for tumour cells as well as VDA
• Vascular disruption traps and concentrates BNC105 within tumour
  – “lock-in” – enhancing its anti-tumour activity
• Enhanced effectiveness in combination with radiation treatment,
  cytotoxic chemotherapy eg cisplatin and biological agents such as
         ®
  Avastin®
• BNC105 doesn’t bind drug pumps associated with resistance to
  treatment and may be used to treat chemotherapy resistant
  tumours
   This combination of attributes distinguishes BNC105 from other
                                                                      6
   VDAs in development
 BNC105 displays potent
efficacy in animal models
BNC105 Phase I Clinical Trial

                     • Commenced February 2008
                     • Investigatory New Drug (IND)
                       from the Federal Drug
                       Administration (FDA)
                     • Aims of trial:
                        • Evaluate safety of BNC105
                          in advanced cancer
                        • To identify Phase II dose
                          level
                     • Initial data indicates anti-
                       tumor activity



                                                      8
   Mesothelioma patient (right pleural),
   administered 8.4 mg/m2 of BNC105,
   cycle 1




                                     3-6h
                                     Post
                                     dose




baseline (pre-dose)


 Dye take-up is blocked in the
 centre of the tumour (seen as
 more black area) post BNC105         24h
 dosing, indicative of VDA effect.   Post
                                     dose   9
BNC105 “On Target” activity in renal cancer
patient




                                              Polymerised
                                              tubulin levels
                                              are reduced by y
                                              treatment with
                                              BNC105




                                                     10
Positive Initial Phase I Results


                                         anti tumor
  • Blood levels consistent with VDA and anti-tumor activity
  • Evidence of VDA activity confirmed by tumour imaging
  • Certain patients achieved stable disease (
            p                                        progression
                                             (cancer p g
    halted) – mesothelioma (asbestos exposure) and renal
    (kidney) cell cancer
  • No complicating side-effects
                    side effects
  • Data suggests BNC105 has ~ >10 fold therapeutic window
    compared to CA4 in cancer patients




                                                               11
What is Best Oncology Indication for BNC105?

                     Australia
Therapeutic Area                 USA        Competing VDA
                      (top 5)

Head & Neck             √         √

Ovarian                 √         √            ASA404, CA4P


Renal                   √         √

Colon                   √         √
GBM ( Brain
Cancer)
                                  √            Azixa, CYT-997

N Small C ll L
Non S ll Cell Lung
                                       CA4P, ASA404, NPI-2358, ABT751
Cancer

Mesothelioma            √

Breast                            √               ASA404
 BNC105 can Potentially Treat Renal Cancer

• Highly vascular tumour - good target for BNC105
• Medical need for new treatment
• Good scientific rationale for combination with mTor inhibitor
  Afinitor®, first oral daily therapy to treat renal cancer
• Strong BNC105 preclinical data
   • Causes vascular shutdown in a model of human renal cell
     cancer
   • Potently kills renal cancer cells
   • Enhances the anti-cancer action of an mTor inhibitor
   • Stimulates expression of mTor inhibitor target     increases
     susceptibility of cancer cells
• Patient in phase I BNC105 trial responded
• Potential fast-track to registration and market
  Open space with respect to competitors
• O           ih                   i

                                                                    13
Renal Cell Cancer Market: Commercial
 pp        y(                    )
Opportunity (First Line Treatment)

• Renal cancer - 3% of human malignancies
      ,              g                        y   ( ,
• 200,000 cases diagnosed worldwide each year (55,000 in the
  USA)
• Five year survival rate in metastatic disease <2%
• Renal cancer is asymptomatic - 40% diagnosed at late stage
                     y p                    g             g
• First line treatments are successful:
   • Sutent (Pfizer) –
         pp                       g     p
      • Approved in 2006 - doubling relapse-free survival from 5 to 11 months
      • Market leader, with market shares of 40% and 60% in Europe and
        59% in the USA
      • US$847M in worldwide sales in 2008
   • Nexavar (Bayer and Onyx) –
      •   Progression-free survival improved from 3 to 6 months
      •   Recent approval in Japan (January 2008)
      •   US$677.8M in sales in 2008, almost exclusively in kidney cancer.
      •   Anticipated sales US$850M in 2009 and US$1B in 2010.


                                                                         14
Renal Cell Cancer Market: Commercial
 pp        y(                     )
Opportunity (Second Line Treatment)

• Afinitor®
  • FDA approved in March 2009
  • Improvement progression-free
    survival from 1.9 to 4 months
  • Sales in renal cell cancer
    estimated to be US$520M
    which will be substantiallyy
    increased by broadening the
    indications (Source: Natixis)




                                    Source: Zacks




                                                    15
Synergy of BNC105 + Afinitor®
increases cancer death
  c eases ca ce deat

BNC105
                      Hypoxic stress                            Cancer Cell Death




                                                          PI3K
                                         mTOR         Disregulated
          VHL
         Defect

                           HIF-1a




          VEGF             PDGF             EGFR                     Afinitor®
         Pathway          Pathway          Pathway


                     Tumor           Abnormal
                  Angiogenesis   Cell Proliferation                              16
Phase II Clinical Trial in Renal Cell Cancer
(Scientific and Commercial Rationale)


• Trial Design
   • Randomised, 2 arm study:
       • BNC105 in combination with Afinitor® and;
                          g    g         p                 patients
       • BNC105 as a single agent in relapsed renal cancer p
         coming off Afinitor®.
   • Primary endpoint: Improvement in 6-month
     progression-free survival
   • Conducted in the US with the Hoosier Oncology Group
     (HOG):
       • Principal Investigator :Dr Tom Hutson, Baylor Centre,
         Dallas
       • Network 10+ sites
Commercial strategy to license post Phase II data


                                                                  17
Strategy to license BNC105 with Phase II
data: Novel oncology products are “hot
      t ”
property”
• Antisoma’s VDA partnered in Phase II with
  Novartis:
  • 2007 total deal value up to US$890 million + royalties
  • US$75 million up front
• Arqule’s c-MET inhibitor partnered in Phase II
  with Daiichi Sankyo:
  • 2008 total deal value up to US$560 million + royalties
  • US$60 million up front
• Deal values for targeted cancer therapies in
  Phase I:
  Ph    I
  • Average total deal value up to US$300 million +
    royalties
  • Average up front payment US$30 million

                                                         18
BNC210 Combines the Best Features of Major
Classes of Current Treatments for Anxiety


              No          No     No Memory     Fast    No Drug-Drug
   Class    Sedation   Addiction Impairment   Acting   Interaction*




  BNC210



   Valium     x          x          x
   Prozac                                      x           x

   * As determined by effects on liver metabolism                     19
 Anxiety is a Prevalent Disorder
 with an Unmet Need
“Anxiety Disorders affect about 40 million Americans each year”
   Generalized A i
 ► G      li d Anxiety Di     d          ff
                         Disorder (GAD) affects                                                         12%
   6.8 million in the US                                                                                      4%                   GAD
                                                                               34%
 ► Women are twice as likely to be affected                                                                                        OCD
                                                                                                                 10%
   than men                                                                                                                        PD

 ► Very likely to be co-morbid with depression                                                                                     PTSD
                                                                                                                                   SAD
 ► Anxiety drugs have been amongst the                                                                          14%
                                                                                                                                   Phobias
   biggest blockbusters e.g. Valium, Prozac
           billion pa worldwide)
   (US$15 billi          ld id )                                                          26%

 ► Most anxiety drugs have major side-effects
 ► Market need for a safe, fast acting, non-                                    http://www.adaa.org/AboutADAA/PressRoom/Stats&Facts.asp
   sedating drug
 ► BNC210 suitable for both acute and chronic
   (GAD) forms of anxiety

   Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence, severity, and comorbidity of twelve-month DSM-IV disorders in the
   National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry, 2005 Jun;62(6):617-27.

                                                                                                                   20
BNC210 Clinical Trial Ongoing:
Anticipated Completion End 2009


                       Healthy Volunteers



   Stage I
      g        ●To assess the safety and tolerability of BNC210
               ●Escalating single doses
 Single Dose
    Study      ●Preliminary assessment of mood and side effects with
                Visual Analogue Scales

               Complete end Sept 2009


  Stage II
     g         ● To expand the safety and tolerability assessment of
                           i     l t doses and more subjects per dose
                 BNC210 using select d        d           bj t     d
  Expanded
               ● To investigate pharmacodynamic parameters using EEG
 Single Dose
    Study      ● Preliminary assessment of mood and side effects with
                 Visual Analogue Scales
               Complete end 2009
                                                                        21
BNC210 Summary

• Novel proprietary (patented by Bionomics) compound
  Potent   i l ti    ti it
• P t t anxiolytic activity
• Excellent oral bioavailability with duration of action > 6
  hours
  Key competitive advantages:
• K        titi    d   t
   • Therapeutic window > 1,000X relative to anticipated side-
     effects for benzodiazepines e.g. Valium
       • No memory impairment
       • No sedation
       • No impaired motor coordination
       • No addiction
   • Unlikely to result in adverse drug-drug interactions seen with
     other treatments e.g. Prozac
   • Rapid onset of action
  St t     t     t     ith Ph      d t
  Strategy to partner with Phase I data

                                                                 22
 Kv1.3: Multiple Sclerosis


Current Treatments        Kv1.3: Novel Drug
• Partially Effective     • Found on T cells
• Major Side Effects      • Blockers of Kv1.3 stop
• Injected                  proliferation of cells
                            from MS patients
• Estimated market is
  US$2 billion              Bionomics
                          • Bionomics’ and Merck
                            Serono seeking
• Market need for safe,     compounds which are:
  effective oral drug        • Highly selective and potent =
                               effective without side-effects
                             • Orally acting
                               Extension of di
                             • E t   i              i di ti
                                          f disease indication
Upcoming Milestones

          Milestone                           Status Date
 BNC105   Present data at ASCO & AACR
          P       d                                 Q2 2009
          Conferences
          Identify dose levels for Phase II         Q2 2009
          trial
          Initiate Phase II study                   Q4 2009

          Expand Opportunity – additional           Q4 2009
          Phase II study

 BNC210   Submit regulatory documentation           Q1 2009
          for Phase I trial

          Initiate Phase I trial                    Q3 2009

          Complete Phase I trial                    Q4 2009




                                                         24
Financial Position

• Strong year:
   • Revenue to 30 June 2009 excluding grants: $4.29M
   • Reflects increasing inflow of license fees and payments under
     Merck Serono agreement which can be expected to become
     more substantial as the licensed compounds progress through
     clinical development and to market
   • Neurofit income from contract research services increased by
     108% to $1.94M
   • Non R&D expenses reduced by 27% - tight cost control,
     careful cost management


• Cash at 30 June 2009: $4.76M




                                                               25
Use of Funds

Projected Cash Flow to 30 June 2011            A$M

Capital i          C h     June 2009
C it l raise $15M+ Cash 30 J                   19 7
                                               19.7

Projected income (contracted R&D                7.1
revenue + net Neurofit contribution)
Available Funds                                26.8
Expenses:
BNC105 Phase II Clinical Program:
- Kidney cancer:                       $8.1M
- Mesothelioma (lung cancer):          $5.5M

BNC210 Phase Ib Clinical Trial:        $3.6M
Working Capital:                       $3.2M
Total Expenses                                 (20.4)
Projected cash 30 June 2011                      6.4
                                                        26
     Bionomics
www.bionomics.com.au

								
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