Corporate Overview<br />June 2011<br />
Forward Looking Statements<br />©2011 Allon Therapeutics Inc.<br />2<br />Statements contained herein, other than those wh...
<ul><li>Portfolio of novel neuroprotective peptides with broad clinical applicability & disease-modifying mechanism
International pivotal study underway in orphan market with SPA, Orphan Status (US & EU) and Fast Track
Lead demonstrated human proof of concept in two Phase 2 studies + positive imaging biomarker data
Pursue orphan market for first approval and proceed to major markets post approval with 2nd generation product
Financial resources to execute through major milestones
Strong intellectual property estate
Management team with proven & repeated track record</li></ul>Allon Overview<br />3<br />©2011 Allon Therapeutics Inc.<br />
©2011 Allon Therapeutics Inc.<br />4<br />Injury<br />Disease<br />Glial-derived neuroprotectants<br />Activity-Dependent ...
Dementia/Cognitive impairment
AD, CIAS, FTD (PSP)</li></ul>ADNF platform<br /><ul><li>D-SAL; AL-309 (9 a.a.)
SAL; AL-209 (9 a.a.)
Neuropathies</li></li></ul><li>Fundamental Mechanism of Action<br />©2011 Allon Therapeutics Inc.<br />5<br />Microtubules...
Tau hyperphosphorylation
Progressive loss of function
Leads to cell death</li></ul>Neuroprotection<br /><ul><li>Davunetide crosses the human blood brain barrier
Reduces Tau hyperphosphorylation
Stabilizes and repairs microtubules
Restores neuronal structure and function</li></li></ul><li>ADNP PlatformDavunetide<br />©2011 Allon Therapeutics Inc.<br /...
Clinical Strategy<br />©2011 Allon Therapeutics Inc.<br />7<br />P2a – AD Program<br /><ul><li>144 subjects
2 doses (5 mg/QD, 15 mg BID)
12 weeks
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Allon Corporate Overview 2011

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Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on bringing to market innovative central nervous system therapies. Allon’s lead drug, davunetide, is proceeding in a pivotal Phase 2/3 clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). This pivotal trial is based upon statistically significant human efficacy demonstrated in amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data.

The Company is listed on the Toronto Stock Exchange (TSX:NPC) and based in Vancouver.

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Allon Corporate Overview 2011

  1. 1. Corporate Overview<br />June 2011<br />
  2. 2. Forward Looking Statements<br />©2011 Allon Therapeutics Inc.<br />2<br />Statements contained herein, other than those which are strictly statements of historical fact may include forward-looking information. Such statements will typically contain words such as "believes", "may", "plans", "will", "estimate", "continue", "anticipates", "intends", "expects", and similar expressions. While forward-looking statements represent management’s outlook based on assumptions that management believes are reasonable, forward-looking statements by their nature are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by them. Such factors include, among others, the inherent uncertainty involved in scientific research and drug development, Allon's early stage of development, lack of product revenues, its additional capital requirements, the risks associated with successful completion of clinical trials and the long lead-times and high costs associated with obtaining regulatory approval to market any product which Allon may eventually develop. Other risk factors include the limited protections afforded by intellectual property rights, rapid technology and product obsolescence in a highly competitive environment and Allon’s dependence on collaborative partners and contract research organizations. These factors can be reviewed in Allon’s public filings at www.SEDAR.com and should be considered carefully. Readers are cautioned not to place undue reliance on such forward-looking statements. Similarly, nothing in this presentation is meant to promote a pharmaceutical product or make a regulated claim of efficacy.<br />
  3. 3. <ul><li>Portfolio of novel neuroprotective peptides with broad clinical applicability & disease-modifying mechanism
  4. 4. International pivotal study underway in orphan market with SPA, Orphan Status (US & EU) and Fast Track
  5. 5. Lead demonstrated human proof of concept in two Phase 2 studies + positive imaging biomarker data
  6. 6. Pursue orphan market for first approval and proceed to major markets post approval with 2nd generation product
  7. 7. Financial resources to execute through major milestones
  8. 8. Strong intellectual property estate
  9. 9. Management team with proven & repeated track record</li></ul>Allon Overview<br />3<br />©2011 Allon Therapeutics Inc.<br />
  10. 10. ©2011 Allon Therapeutics Inc.<br />4<br />Injury<br />Disease<br />Glial-derived neuroprotectants<br />Activity-Dependent <br />Neurotrophic Factor<br />Activity-Dependent <br />Neuroprotective Protein<br />SALLRSIPA<br />NAPVSIPQ<br />Allon’sNeuroprotective Platforms<br />ADNP platform<br /><ul><li>Davunetide; NAP; AL-108
  11. 11. Dementia/Cognitive impairment
  12. 12. AD, CIAS, FTD (PSP)</li></ul>ADNF platform<br /><ul><li>D-SAL; AL-309 (9 a.a.)
  13. 13. SAL; AL-209 (9 a.a.)
  14. 14. Neuropathies</li></li></ul><li>Fundamental Mechanism of Action<br />©2011 Allon Therapeutics Inc.<br />5<br />Microtubules<br />Essential for neuronal structure and function<br />Neurodegeneration<br /><ul><li>Destabilization and breakdown of microtubules
  15. 15. Tau hyperphosphorylation
  16. 16. Progressive loss of function
  17. 17. Leads to cell death</li></ul>Neuroprotection<br /><ul><li>Davunetide crosses the human blood brain barrier
  18. 18. Reduces Tau hyperphosphorylation
  19. 19. Stabilizes and repairs microtubules
  20. 20. Restores neuronal structure and function</li></li></ul><li>ADNP PlatformDavunetide<br />©2011 Allon Therapeutics Inc.<br />6<br />
  21. 21. Clinical Strategy<br />©2011 Allon Therapeutics Inc.<br />7<br />P2a – AD Program<br /><ul><li>144 subjects
  22. 22. 2 doses (5 mg/QD, 15 mg BID)
  23. 23. 12 weeks
  24. 24. Randomized, placebo controlled, double blind
  25. 25. 17 US sites</li></ul>P2a – Schizophrenia<br /><ul><li>63 subjects
  26. 26. 2 doses (5 mg QD, 15 mg BID)
  27. 27. 12 weeks
  28. 28. Randomized, placebo controlled double blind
  29. 29. 7 US sites</li></ul>P2a – Imaging Biomarker<br /><ul><li>18 subjects
  30. 30. 2 doses (5 mg/QD, 15 mg BID)
  31. 31. 12 weeks
  32. 32. Randomized, placebo controlled double blind
  33. 33. 3 US sites</li></ul>P2/3 Pivotal Study<br /><ul><li>Progressive Supranuclear Palsy
  34. 34. Early onset dementia
  35. 35. Rapid decline
  36. 36. No effective treatment
  37. 37. Validated rating scale
  38. 38. Powered as a pivotal study
  39. 39. Defining future steps in AD/Schizophrenia
  40. 40. 2nd generation formulation underway for market segmentation</li></ul>P/C & Phase 1 <br /><ul><li>Safety/PK Studies
  41. 41. Safety to 60 mg/day
  42. 42. CSF penetration
  43. 43. Brain via systemic distribution
  44. 44. Healthy normal/aged, AD, FTD
  45. 45. 35 P/C studies in 17 models</li></ul>410 subjects dosed with davunetide<br />
  46. 46. Statistically Significant Improvement on Memory (aMCI)<br />8<br />Follow-up<br />Drug administration<br /><ul><li>Statistically significant, dose dependent and durable impact seen at 12 second delay when memory is measured</li></ul>©2011 Allon Therapeutics Inc. <br />
  47. 47. Statistically Significant Improvement on Memory (aMCI)<br />©2011 Allon Therapeutics Inc.<br />9<br />Follow-up<br />Drug administration<br /><ul><li>Statistically significant, dose dependent, and durable impact on working memory</li></li></ul><li>Statistically Significant Improvement on ADLs<br />©2011 Allon Therapeutics Inc.<br />10<br />UPSA Change-from-Baseline<br />50<br />Week 6<br />Week 12<br />40<br />30<br />20<br />T-Score (CFB)<br />10<br />0<br />-10<br />-20<br />-30<br />placebo<br />5 mg QD<br />15 mg BID<br />placebo<br />5 mg QD<br />15 mg BID<br />Conclusion<br /><ul><li>Statistically significant treatment effect of davunetide 5 mg QD (p=0.023) and combined treatment groups versus placebo (p=0.015) (mixed model ANCOVA)
  48. 48. No statistical significance between groups</li></li></ul><li>Statistically Significant Improvement on Biomarker<br />©2011 Allon Therapeutics Inc.<br />11<br />Wilcoxon non-parametric <br />Exact Test<br />p=0.07<br />15mg BID vs placebo <br /><ul><li>Non-parametric analysis shows strong trend towards significant treatment effect versus placebo
  49. 49. Statistically significant increase in NAA levels found in patients treated with davunetide relative to baseline (p=0.017)</li></li></ul><li>Summary of Davunetide Efficacy Data<br /><ul><li>Statistically significant treatment effect on:</li></ul>Working memory and visual learning & memory<br />Activities of daily living<br />Brain biomarker of neuronal integrity (NAA/Cr)<br /><ul><li>Positive trends across multiple additional outcomes
  50. 50. Safe and Well-Tolerated</li></ul>Therefore:<br /><ul><li>Human proof of concept; consistent with pre-clinical pharmacology; consistent with microtubule hypothesis
  51. 51. Strong basis for PSP pivotal study
  52. 52. Most advanced tau therapy in the world</li></ul>©2011 Allon Therapeutics Inc.<br />12<br />
  53. 53. Clinical PSP Study<br /><ul><li>Patient population with homogeneous pathology
  54. 54. Davunetide appears to be efficacious on this pathology in both pre-clinical and human clinical studies
  55. 55. Decline is rapid -- facilitates reasonable study length
  56. 56. No effective therapy whatsoever
  57. 57. Patients are reliably diagnosed
  58. 58. PSPRS is a validated rating scale of clinically relevant outcomes</li></ul>Based on UPDRS, a single approvable endpoint in PD<br />Reliably predictive of patient status and essentially linear decline<br /><ul><li>These criteria plus completely unmet medical need provide regulatory clarity</li></ul>SPA agreed<br />Orphan granted in US and EU<br />Fast Track granted<br />©2011 Allon Therapeutics Inc.<br />13<br />
  59. 59. Phase 2/3 Progressive Supranuclear Palsy<br /><ul><li>Special Protocol Assessment in place
  60. 60. 300 subjects randomized 1:1
  61. 61. 30 mgdavunetideBID or placebo
  62. 62. 12 months treatment
  63. 63. US, Canada, UK, France, Germany, & Australia
  64. 64. Primary outcomes: PSP Rating Scale and SEADL
  65. 65. Secondary outcomes: CGI, MRI, + various exploratory
  66. 66. Very tight inclusion/exclusion criteria
  67. 67. Enrolment commenced Q4 ’10; 50% enrolled (Q2’11)</li></ul>©2011 Allon Therapeutics Inc.<br />14<br />
  68. 68. Davunetide Commercial Research<br />©2011 Allon Therapeutics Inc.<br />15<br />Current knowledge base on PSP market dynamics is limited<br /><ul><li>No marketed products in PSP
  69. 69. Modest literature on prevalence rates
  70. 70. No off-the-shelf resources</li></ul>Allon has undertaken <br /><ul><li>Primary research into PSP prevalence in US/EU
  71. 71. Blinded davunetide product profile
  72. 72. Aim to understand the roles of specialists that refer, diagnose & treat
  73. 73. Pricing and reimbursement study in EU
  74. 74. Pricing and reimbursement study in US (underway)
  75. 75. Sales Forecasts</li></li></ul><li>Market Status<br /><ul><li>Consulted clinicians & payers: ~125 US/EU
  76. 76. ~25,000 cases US / ~40,000 cases EU
  77. 77. Twice as prevalent as Huntington’s
  78. 78. More prevalent than ALS
  79. 79. Clinicians said if approved davunetide would be clinically appropriate for 84% of their patients
  80. 80. Very conservative pricing assumptions suggest PSP has the potential to be a >$700-mm market</li></ul>©2011 Allon Therapeutics Inc.<br />16<br />
  81. 81. ©2011 Allon Therapeutics Inc.<br />17<br />Important to my practice<br />2%<br />65%<br />2<br />1<br />3<br />7<br />6<br />4<br />5<br />Strongly disagree<br />Strongly agree<br />Offers a unique benefit<br />3%<br />2%<br />51%<br />78%<br />Clear<br />2<br />2<br />1<br />1<br />3<br />3<br />7<br />7<br />6<br />6<br />4<br />5<br />4<br />5<br />Strongly disagree<br />Strongly agree<br />Strongly disagree<br />Strongly agree<br />Important to my patients<br />2%<br />75%<br />1%<br />49%<br />Believable<br />2<br />1<br />3<br />2<br />7<br />6<br />1<br />4<br />5<br />3<br />7<br />6<br />4<br />5<br />Strongly disagree<br />Strongly agree<br />Strongly disagree<br />Strongly agree<br />Motivating to prescribe<br />3%<br />72%<br />2<br />1<br />3<br />7<br />6<br />4<br />5<br />Strongly disagree<br />Strongly agree<br />Davunetide Product Profile Perceptions<br />Neuros agree that davunetideis valuable, unique, important and motivating to prescribe; less agreement that the product profile is clear and believable<br /> Top 2 Bottom 2<br /> Top 2 Bottom 2<br />By % of Neuros:<br />Distribution<br />Valuable addition to my armamentarium<br />2%<br />80%<br />2<br />1<br />3<br />7<br />6<br />4<br />5<br />Strongly disagree<br />Strongly agree<br />----------------------------------------------------------------------------------Q: Please select the response below which best describes your reaction to Product X for each of the statements below. Perceptions ordered descending by Top 2-box score. (N = 81)<br />17<br />
  82. 82. Davunetide Commercialization Strategy<br />©2011 Allon Therapeutics Inc.<br />18<br /><ul><li>Pursue PSP as first approval (>$700-mm market)
  83. 83. Move to other tau-FTDs post approval (~ 4x the market)
  84. 84. Use 2nd generation product to exploit major markets
  85. 85. Allon market in North America pursue commercialization partner xUS
  86. 86. Detail ~2,500 specialists at major centers</li></li></ul><li>Orphan Drug Sales Potential<br />©2011 Allon Therapeutics Inc.<br />19<br />Xenazine<br />Renagel<br />$1,400<br />$1,200<br />Tracleer<br />$1,000<br />$800<br />Worldwide sales (USD, millions)<br />$600<br />$400<br />$200<br />$-<br />1<br />2<br />3<br />4<br />5<br />6<br />7<br />8<br />9<br />Year from launch<br />Xeanzine forecasts from Year 3 (Medtrack)<br /><ul><li>Orphan drug sales can provide rapid sales growth and blockbuster potential</li></li></ul><li>Balanced Clinical Development Strategy<br />©2011 Allon Therapeutics Inc.<br />20<br />Phase 2<br />Phase 1<br />Phase 3<br />Preclinical<br />Indication<br />PSP<br />Alzheimer’s<br />Schizophrenia<br />Parkinson’s<br />Davunetide<br />Dementias<br />2nd Generation<br />Neuropathy<br />AL-309<br />Neuroprotection<br />AL-408<br />Neuroprotection<br />AL-508<br />Underway<br />Completed<br />
  87. 87. Capital Snapshot<br /><ul><li>$15.1-mm available for clinical development
  88. 88. ~78-mm shares (106-mm fd), no prefs, no debt
  89. 89. Market cap ~ $35-mm
  90. 90. Volume ~ 125 k/day
  91. 91. Institutional ownership ~ 60%</li></ul>©2011 Allon Therapeutics Inc.<br />21<br />
  92. 92. Allon Summary<br /><ul><li>Phase 2 human proof of concept on memory, activities of daily living and imaging biomarker
  93. 93. International pivotal study underway with SPA
  94. 94. First clinical program validating the tau pathway
  95. 95. Blockbuster market potential
  96. 96. 15 families of 55 issued composition of matter and use patents & 35+ pending
  97. 97. Broaden the pipeline assets
  98. 98. Management team with consistent track record of execution and achievement</li></ul>©2011 Allon Therapeutics Inc.<br />22<br />
  99. 99. www.allontherapeutics.com<br />23<br />©2011 Allon Therapeutics Inc. <br />

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