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Annual & Special Meeting of Shareholders December 5, 2013
Dr. Wayne R. Danter President & CEO
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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
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Conventional drug development process is long, expensive & characterized by a high risk of failure
11 – 15 years
$1 billion or more
1 FDA approval 4
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CHEMSAS® efficiently accelerates the drug discovery process
Reduces discovery, optimization & lead selection by 1.5 to 3 yrs.
Saving significant $$$
Increasing revenue period under patent protection
Computerized
Hybrid
Expert
Molecular
Structure
Activity
Screening
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Computational simulation of traditional ‘wet lab’ drug discovery process
Failures occur in computer simulations, not at the ‘research bench’
Higher probability of clinical & commercial success
Proprietary technology
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Two-pronged commercial validation and revenue strategy
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CHEMSAS® R&D collaborations
Licensing our own drug compounds
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Typical CHEMSAS® R&D collaboration
Partner has specific novel drug target
Receive upfront development fee from Partner and build a compound library
Library testing and evaluation at Partner’s expense
COTI typically retains IP ownership of compounds and all data until licensed
Partner proceeds with development under a license with upfront, milestone, and royalty payments
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CHEMSAS® R&D Collaboration:
Western University &
Dr. Arthur Brown
Target:
SOX9 inhibitor
Deal terms:
$25k upfront cash + 50/50 share of IP & all future revenues; COTI pays costs of discovery & Western pays for testing
Progress:
COTI discovered 7 novel compounds; Western testing ongoing; several compounds with positive initial test results
Expected revenue timing:
2015
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Target:
Angiogenesis inhibitor
Deal terms:
50/50 share of revenues; expect a traditional license; COTI pays costs of discovery & patents, DCI pays for synthesis
Progress:
COTI discovered 3 novel compounds; Structures passed initial pharma screens; Delmar now synthesizing
Expected revenue timing:
Late 2014
CHEMSAS® R&D Collaboration:
Delmar Chemicals Inc.
(Open Innovation Drug Discovery Program)
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Target:
Confidential
Deal terms:
Option to license – upfront payment, milestones and royalty; COTI discovers, optimizes and synthesizes; Pharma tests
Progress:
COTI identified > 40 compounds; Initial testing nearing completion; Pharma testing to identify candidates for further optimization
Expected revenue timing:
2015
CHEMSAS® R&D Collaboration:
Multinational Pharmaceutical Company
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Licensing our own compounds
Pursuing a license for our lead oncology compound, COTI-2
Traditional license structure – upfront payment, milestones, royalty
Other CHEMSAS® drug discovery projects in queue (i.e. AML)
COTI-2:
scientific and business significance
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Effective against cancers with mutations of the p53 gene
> 50% of all human cancers have a p53 mutation (eg. ~ 95% of ovarian cancers)
Mechanism of action confirmed by thought leader Dr. Gordon Mills at MD Anderson Cancer Center (June 2013)
Novel, first in class
COTI-2:
intellectual property overview
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5 U.S. patents granted – strengthens value proposition
Ongoing filings, with patents pending in U.S., Europe, Canada and Japan
Own all intellectual property with no license obligations
COTI-2: next major activities & milestones
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In final 2-species toxicity studies – completion expected in first half of 2014
FDA filing expected mid-2014 (leading to Phase 1 clinical trial)
Pursuing orphan drug &/or breakthrough therapy status
Seeking optimal partner for clinical development
COTI-2: licensing update
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Continued strong interest in COTI-2
Due to the novelty of the MOA, potential partners want:
Better understanding of MOA
Human data
COTI-2: worldwide license represents significant revenue potential
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Top 5 2012 Phase 1/2 oncology licensing deals disclosed (1):
Upfront payments of approx. $25-$92 million
Milestone payments between $550-$1,100 million
Royalties on net sales
1st half of 2013 (2) – 16 phase 1 licensing deals with 6 in cancer – ave upfront $30m
(1) Medius Associates (2) Thomson Reuters
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Looking ahead: other revenue generating CHEMSAS® applications
CHEMFirm Small molecule profiling and investment due diligence tool
Drug library profiling Based on customer identified criteria
Drug repurposing Finding new purposes for drugs coming off patent
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Project ROSALIND
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 ~$35B market by 2018*
* Markets and Markets (2013)
Annual & Special Meeting of Shareholders December 5, 2013
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