ReliF

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This was our presentation for our imaginary product for the commercialization workshop. Note, all "research results" and illustrations are totally made up and and therefore not necessarily reflecting reality (== biological processes). This presentation was created as part of the learning experience of how to pitch biological research to venture capitalists.

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ReliF

  1. 1. Relif ® Feel the relief Dr. Denis C. Bauer CEO Prof. Dr. Cho l Hee Jung CSO Dr. Andrew Ringsmuth Business Development Manager Dr. Kimberly Wadsworth IP Manager
  2. 2. Introduction <ul><li>Currently,1.3 Million people suffer from acute depression. </li></ul><ul><li>Estimated to increase exponentially within 10 years. </li></ul><ul><li>Don Monger : “Depression will be the major impact on modern society” </li></ul>On the Threshold of Eternity by Vincent Van Gogh What if depression can be reduced to a small inconvenience - like headache?
  3. 3. Overview <ul><li>Drug development Prof. Dr. Chol Hee Jung </li></ul><ul><ul><li>Scientific Overview </li></ul></ul><ul><ul><li>Science behind the reliF ® approach </li></ul></ul><ul><li>Motivation and Progress </li></ul><ul><ul><li>Market analysis </li></ul></ul><ul><ul><li>Financial overview </li></ul></ul><ul><li>IP portfolio </li></ul><ul><li>Pitch </li></ul>
  4. 4. Serotonin messaging <ul><li>Pre-synaptic neuron : releases serotonin </li></ul><ul><li>Post-synaptic neuron : recognizes serotonin with 5-HRR and relays the signal. </li></ul><ul><li>In healthy individuals, about 90% of serotonin released into the synaptic cleft is re-absorbed into pre-synaptic neurons with only 10% bound to post-synaptic neurons. </li></ul>
  5. 5. Depression, treatment, side-effect <ul><li>Failure of serotonin messaging is currently regarded as the most likely cause of Depression. </li></ul><ul><li>Traditional treatment blocks serotonin re-absorption (SSRI) increasing the amount of post-synaptic serotonin binding. </li></ul><ul><li>Results in loss of serotonin. </li></ul>
  6. 6. Serotonin Messaging by transporting <ul><li>No serotonin loss in serotonin messaging </li></ul><ul><ul><li>Jung, C.H., Serotonin messaging mediated by 5-HR-channels not 5-HR-receptor, Nature , 2006, 20, 1159-1165 </li></ul></ul><ul><ul><li>Jung, C.H., Total serotonin concentration unaffected in Depression type I, Nature , 2005, 20, 1159-1165 </li></ul></ul><ul><li>No serotonin loss in serotonin messaging </li></ul><ul><ul><li>10% of serotonin released from pre-synaptic neurons is absorbed into post-synaptic neurons. </li></ul></ul>
  7. 7. Abnormal serotonin-concentration in Depression <ul><li>Low serotonin concentration in post-synaptic neurons. </li></ul><ul><ul><li>Jakobs, D.R., et al., Serotonin concentration involved in depression type I, Science , 2006, 21, 501-509 </li></ul></ul>Fig3. Measured serotonin concentration in pre- and post - synap tic neurons for time point 5 and 20 in control group and depression (Drc-). The Figure shows that there is no lack of serotonin in the pre- synap tic neurons , yet absorbed serotonin levels in post-synap tic are too low .
  8. 8. Normal number of HRCs <ul><li>No observable difference in concentration of HRCs in post-synaptic neurons. </li></ul>Jung, C.H. et al., SSRI induced 5-HR increase only a hack , Nature , 2006, 21, 180-185 Fig2. Flourescence images of pre - and post - synap tic neurons for the control group and depression (Drc-). The images show that the amount of 5-HR channels (red fluorescence) is not reduced in Drc-, yet the absorbed serotonin (green fluorescence) in the post-synap tic neurons is significantly reduced. Control Drc-
  9. 9. Correlation of Fsr9 with low serotonin absorption <ul><li>Fsr9 , responsible for the serotonin concentration in post-synaptic neurons. </li></ul>Fig2. Correlation between over expression of Fsr9 and reduced serotonin intake of post - synap tic neurons in depression (Drc-). Panel A : Fsr9 in Drc- is present in high concentrations very early in the time course. Panel B : The early onset of Fsr9 stops the absorption of serotonin into the post - synap tic neurons , resulting in an overall lower serotonin concentration. Chen, L.L. et al. ,The role of Fsr9 in Depression Type I , Int J Dev Neurosci, 2007, 22, 180-185
  10. 10. F sr9 blocks 5-HR c h annels <ul><li>Fsr9 , adjust the serotonin concentration. </li></ul><ul><li>Not in regulatory manner, but in physical manner </li></ul>Fig2. Flourescence images of pre - and post - synap tic neurons in depression (Drc-) for 5-HR C and Fsr 9. The images show the co-localization of Fsr 9 (green fluorescence) and 5-HRC (blue fluorescence) as yellow fluorescence. Chen, L.L. et al. , Co-localization of 5-HRC and Fsr9 suggest a new drug target for depression, Neurophysiology , 2007, 20
  11. 11. Serotonin messaging - The full picture Jung, C.H. et al. , RNA interference of fsr9 - a new generation antidepressant, Nature , 2007, 23 Vesicle-mediated release licensed by Capsulution ®
  12. 12. Efficiency time 20 Jung, C.H. et al. , RNA interference of fsr9 - a new generation antidepressant, Nature , 2007, 23
  13. 13. Comparison Jung, C.H. et al. , The breakthrough in antidepressants, Nature , 2008, in submission actual serotonin loss no known Side effects short-term long-term Solution intensive neutral Biological resources weeks hours Onset SSRI reliF ®
  14. 14. The reliF ® Approach <ul><li>Fsr9-specific RNAi molecules are transported to serotonin absorbing synapses . </li></ul><ul><li>Transport is mediated by glycosylation-pattern recognizing vesicles produced by Capsulution ® </li></ul><ul><li>The constant delivery of RNAi molecules prevents the premature onset of Fsr9 expression . </li></ul><ul><li>The normal absorption period of HRCs is restored. </li></ul><ul><li>Leading to a healthy concentration of serotonin in the post - synap tic neurons , with no known side effects . </li></ul>Jung, C.H. et al. , RNA interference of fsr9 - a new generation antidepressant, Nature , 2007, 23
  15. 15. Overview <ul><li>Goal - Develop an effective, side-effect free drug to provide fast relief from depression. </li></ul><ul><li>Motivation and Progress Dr. Andrew Ringsmuth </li></ul><ul><ul><li>Market analysis </li></ul></ul><ul><ul><li>Financial overview </li></ul></ul><ul><li>IP Portfolio </li></ul><ul><li>Pitch </li></ul>
  16. 16. Market for reliF ® <ul><li>Depression affects 7-18% of the population (In USA, 14 million adults/yr diagnosed) </li></ul><ul><li>Clinical depression is the leading cause of disability in North America </li></ul><ul><li>Expected to become the second leading cause worldwide by 2020 (World Health Organization) </li></ul>
  17. 17. The existing world market (2006)* <ul><li>Antidepressant drugs (SSRIs, NRIs, MAOIs) </li></ul><ul><ul><li>US$17 billion </li></ul></ul><ul><li>Psychotherapy </li></ul><ul><ul><li>US$5.2 billion </li></ul></ul><ul><li>Electroconvulsive therapy </li></ul><ul><ul><li>US$120 million </li></ul></ul><ul><li>Other methods (e.g. acupuncture, hypnotherapy, meditation) </li></ul><ul><ul><li>Est. US$3.5 billion </li></ul></ul><ul><ul><li>Total annual market value US$25.82 billion </li></ul></ul><ul><ul><li>Projected market growth **: >5.2% by 2010 (> US$27.16 billion ) </li></ul></ul><ul><ul><li>*World Health Organisation annual report 2006 </li></ul></ul><ul><ul><li>**GlaxoSmithKline, 2006 </li></ul></ul>
  18. 18. The reliF ® advantage <ul><li>Problems with SSRIs (7 FDA approved, 87% of existing antidepressant market): </li></ul><ul><ul><li>Slow acting (upto 6-8wks. 55% of prescriptions accompany psychotherapeutic treatments) </li></ul></ul><ul><ul><li>Unpredictable efficacy and side effects (Average sufferer trials 1 drug unsuccessfully + ) </li></ul></ul><ul><li>reliF </li></ul><ul><ul><li>Fast acting (same day) </li></ul></ul><ul><ul><li>Shown to be effective in >97% cases where an SSRI is effective ++ </li></ul></ul><ul><ul><li>No known side effects </li></ul></ul><ul><li>Predicted cost to consumer </li></ul><ul><ul><li>5-15% above most popular SSRI ( Cymbalta ) </li></ul></ul><ul><ul><li>Analysts predict price to be competitive </li></ul></ul><ul><ul><li>+ Davis, K. & James, P. (2006). ‘The efficacy of drug-based depression treatments’ . J. Neur. Psych. 131 (3): 496-507. </li></ul></ul><ul><li>++ Jung, C.H. et al. , RNA interference of fsr9 - a new generation antidepressant, Nature , 2007, 23. </li></ul>
  19. 19. Expanding market potential <ul><li>Evidence 1 to suggest that reliF technology is adaptable to other depression-associated neurotransmitters (targeted by other existing antidepressants) </li></ul><ul><li>R&D costs for adaptation << potential market value </li></ul>1 Jung, C.H. et al. , RNA interference of fsr9 - a new generation antidepressant, Nature , 2007, 23
  20. 20. Investment opportunity <ul><li>Investment to complete Phase II (3-5 years): </li></ul><ul><ul><li>AUD $3.8 million (>$2.0 million startup + milestone payments) </li></ul></ul><ul><li>Benefits to investor during Phase II: </li></ul><ul><ul><li>40% share in permON </li></ul></ul><ul><ul><li>Position on board of directors </li></ul></ul><ul><li>permON exit strategy: </li></ul><ul><ul><li>Option 1: Licensing </li></ul></ul><ul><ul><ul><li>Initial licensing fee: ~AUD $25 million </li></ul></ul></ul><ul><ul><ul><li>Worldwide royalties: 7-10% (subj. to neg.) </li></ul></ul></ul><ul><ul><li>Option 2: Sale </li></ul></ul><ul><ul><ul><li>Complete sale: >AUD $100 million </li></ul></ul></ul><ul><ul><ul><li>Partial sale: Retain a part share in permON when reliF goes to market </li></ul></ul></ul><ul><li>Investor return: </li></ul><ul><ul><li>Option 1: </li></ul></ul><ul><ul><ul><li>Initial licensing: ~AUD: $10 million </li></ul></ul></ul><ul><ul><ul><li>40% share in permON royalties (> USD $700 million in first year, assuming 5-10% </li></ul></ul></ul><ul><ul><ul><li>share of SSRI market) </li></ul></ul></ul><ul><ul><li>Option 2: </li></ul></ul><ul><ul><ul><li>Complete sale: >AUD $40 million </li></ul></ul></ul><ul><ul><ul><li>Partial sale: Return determined by share retained </li></ul></ul></ul>
  21. 21. Overview <ul><li>Goal - Develop an effective, side-effect free drug to provide fast relief from depression. </li></ul><ul><li>Motivation and Progress - Large demand and even growing market in the future. </li></ul><ul><li>IP Portfolio Dr. Kimberly Wadsworth </li></ul><ul><li>Pitch </li></ul>
  22. 22. IP Portfolio <ul><li>Scientific discovery: </li></ul><ul><li>Fsr9 discovered: March 2005 </li></ul><ul><li>reliF ® works on Fsr9: December 2005 </li></ul><ul><li>Provisional patent application filed in the USA: </li></ul><ul><li>Fsr9: 13 June 2005 </li></ul><ul><li>reliF ® : 7 January 2006 </li></ul><ul><li>Publications: </li></ul><ul><ul><li>Jung, C.H., Total serotonin concentration unaffected in Depression type I, Nature , 2005, 20, 1159-1165 </li></ul></ul><ul><ul><li>Jung, C.H., Serotonin messaging mediated by 5-HR-channels not 5-HR-receptor, Nature , 2006, 20, 1159-1165 </li></ul></ul><ul><ul><li>Jakobs, D.R., et al., Serotonin concentration involved in depression type I, Science , 2006, 21, 501-509 </li></ul></ul><ul><li> Jung, C.H. et al., SSRI induced 5-HR increase only a hack , Nature , 2006, 21, 180-185 </li></ul><ul><li> Chen, L.L. et al. ,The role of Fsr9 in Depression Type I , Int J Dev Neurosci, 2007, 22, 180-185 </li></ul><ul><li> Chen, L.L. et al. , Co-localization of 5-HRC and Fsr9 suggest a new drug target for depression, </li></ul><ul><li> Neurophysiology , 2007, 20 </li></ul><ul><li> Jung, C.H. et al. , RNA interference of fsr9 - a new generation antidepressant, Nature , 2007, 23 </li></ul><ul><li> Jung, C.H. et al. , The breakthrough in antidepressants, Nature , 2008, in submission </li></ul>
  23. 23. IP Portfolio <ul><li>Formation of permON ® : 3 April 2006 </li></ul><ul><li>PCT (Patent Cooperation Treaty) application filed: </li></ul><ul><li>Fsr9: 12 June 2006 </li></ul><ul><li>reliF ® : 6 January 2007 </li></ul><ul><li>National phase entry: </li></ul><ul><li>Fsr9 (13 December 2007 - 13 January 2008): </li></ul><ul><li>Australia </li></ul><ul><li>United States of America </li></ul><ul><li>Europe </li></ul><ul><li>Japan </li></ul><ul><li>Canada </li></ul><ul><li>Plans to enter national phase for reliF ® in same jurisdictions </li></ul>
  24. 24. Trademarks and licensing <ul><li>Trademarks: </li></ul><ul><li>reliF ® </li></ul><ul><li>permON ® </li></ul><ul><li>Licensing: </li></ul><ul><li>Capsulution ® </li></ul><ul><li>Obtained commercial license </li></ul>
  25. 25. Pitch <ul><li>reliF ® is an effective, side-effect free drug to provide fast relief from depression. </li></ul><ul><li>Large demand in an ever growing market. </li></ul><ul><li>We have taken reliF ® to pre-clinical trials (proof of concept) </li></ul><ul><li>For your $3.8 million, you will see a return of at least $10 million plus royalties. </li></ul>
  26. 26. Outside opinions of leading clinicians <ul><li>“ When depression becomes a small inconvenience, rather than the major impact on human society, we can look forward to a bright future and reliF ® is better suited than vicodin.” </li></ul><ul><li> Dr. Gregory House </li></ul><ul><li>“ reliF ® will be a major breakthrough in depression treatment.” </li></ul><ul><li>Dr. Meredith Grey </li></ul><ul><li>“ reliF ® and Aspirin, two man made miracles” </li></ul><ul><li>Dr. Frank Campion </li></ul>

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