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Pathway to the clinic and beyond


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Presentation providing an overview of the recent milestones and next steps for getting Critical Outcome's p53-dependent cancer treatment, COTI-2, into clinical trials. This presentation was first given by Dr. Wayne Danter at Critical Outcome Technologies' annual shareholders meeting on October 21, 2014.

Critical Outcome Technologies Inc. is listed on the Toronto Venture Exchange under the trading symbol COT.

Published in: Health & Medicine
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Pathway to the clinic and beyond

  1. 1. Pathway to the clinic … and beyond Study design October 2014 TSX-V: TMG
  2. 2. 2 2 Potential breakthrough treatment Effective against many common cancers with a p53 gene mutation > 50% of all human cancers have a p53 mutation (eg. ~ 95% of serous ovarian cancers) COTI-2 overview
  3. 3. Recent milestones Orphan Drug Designation MD Anderson Cancer Center Additional patents
  4. 4. 4 Granted by the FDA for the treatment of ovarian cancer Potentially qualifies us for: Assistance in study design Expedited drug development Development grants & fee reductions 7-year exclusive marketing period Orphan Drug Designation
  5. 5. 5 Very favourable cost structure COTI contribution ~ USD 1.25 million Remainder provided by MD Anderson Dr. Mills and his team are very familiar with COTI-2’s mechanism of action (“MOA”) MD Anderson has the state-of-the-art facilities, technical capabilities & expertise to execute a high quality single site study MD Anderson LOI for Phase 1
  6. 6. 6 6 Independently confirmed COTI-2’s novel p53 dependent MOA Confirmed COTI-2’s selective & potent anti-cancer activity Identified effective dosage 60% lower than in prior animal experiments MD Anderson experiments
  7. 7. 7 6th U.S. patent announced October 3, 2014 1st Japanese patent provides additional licensing opportunities in Japanese & other Asian markets 1st Canadian patent announced October 15, 2014 Patents pending in major international markets Additional patents
  8. 8. Next steps IND filing First patient enrolment Phase 1 completion Out-license vs Phase 2
  9. 9. 9 Planning IND submission to FDA as soon as possible Chemistry manufacturing issues resolved 30 day stability testing in progress Possible delays due to upcoming holiday season Targeting early December 2014 or first week of January 2015 IND filing
  10. 10. 10 Earliest first patient enrolment in February/March 2015 Depends on MDACC, State of Texas and U.S. Federal approval According to MDACC many patients are available and waiting First patient enrollment
  11. 11. 11 40 women with gynecological cancers Enriched with ovarian cancer patients No chemo/radiation for at least 28 days prior to starting Follow for up to 6 months of treatment Expected to take 18 months to complete Interim data at ~ 6 months into the study Phase 1 completion
  12. 12. 12 Positive Phase 1 results create important options: Out-license Validates scientific platform and commercial strategy May not realize maximum shareholder/asset value Phase 2 Moon shot project at MDACC possible Maximizes asset value Out-license vs Phase 2
  13. 13. 13 13 U.S. ovarian indication ~ 190k patients - ~ 96% have a p53 mutation If COTI-2 has meaningful affect on 50% of these ~ 91,200 patients If drug cost to patient is USD 10K per year = USD 912M or ~ CAD 1B At a 10% annual royalty = CAD 100M __________________ Many other indications with p53 mutations are being explored including combination therapy COTI-2 revenue potential
  14. 14. Beyond COTI-2 Drugs in our pipeline R&D collaborations Other applications
  15. 15. 15 Therapy Library /Compound Target CHEMSAS Lead Selection Synthesis Preclinical Phase 1 Oncology COTI-2 AML Colon Small Cell Lung Cancer Library COTI-219 COTI-4 COTI-58 6 other leads Plus projects for MRSA, Multiple sclerosis, Alzheimer’s, and HIV Integrase Inhibitors Drugs in our pipeline
  16. 16. 16 Three existing R&D collaborations expected to bring in milestone payments beginning in 2015 Western University Delmar Chemicals Major Pharma Co. Pursuing additional collaboration opportunities R&D collaborations
  17. 17. 17 17 CHEMFirm – Small molecule profiling & investment due diligence tool Drug library profiling – Based on customer identified criteria Drug repurposing – Finding new purposes for drugs coming off patent Other CHEMSAS applications
  18. 18. 18 18 Programmable computer simulation of human cancer cell signaling Better personalized treatment decisions based on genetic profile of one’s cancer Personalized cancer gene profiling projected to be ~ USD 35B market by 2018* * Markets and Markets (2013) Other applications: ROSALIND
  19. 19. 19 1 2 3 COTI-2 in the clinic in 2015 COTI-2 = significant revenue potential Pipeline of other revenue opportunities Reaching a tipping point
  20. 20. 20 When used anywhere in this presentation, whether oral or written, the words expects, believes, anticipates, estimates and similar expressions are intended to identify forward- looking statements. Forward-looking statements may include statements addressing future financial and operating results of Critical Outcome Technologies Inc. (COTI). COTI bases these forward-looking statements on its current expectations about future events. Such statements are subject to risks and uncertainties including, but not limited to, the successful implementation of COTI’s strategic plans, the acceptance of new products, the obsolescence of existing products, the resolution of potential patent issues, competition, changes in economic conditions, and other risks described in COTI’s public documents such as press releases and filings with the Toronto Stock Exchange and the Ontario Securities Commission. All forward-looking statements are qualified in their entirety by the cautionary statements included in this document and such filings. These risks and uncertainties could cause actual results to differ materially from results expressed or implied by forward-looking statements contained in this presentation. These forward-looking statements speak only as of the date of this presentation. Disclaimer
  21. 21. Pathway to the clinic … and beyond Study design