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Annual &
Special
Meeting of
Shareholders
December 5, 2013
Dr. Wayne R.
Danter
President & CEO
Disclaimer
When used anywhere in this presentation, whether oral or written, the words expects,
believes, anticipates, estimates and similar expressions are intended to identify forwardlooking 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.
3
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
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

5
Computerized
Hybrid
Expert
Molecular
Structure
Activity
Screening
6
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

7
Two-pronged
commercial
validation and
revenue
strategy

1

CHEMSAS® R&D
collaborations

2

Licensing our own
drug compounds

8
 Partner has specific novel drug
target

Typical
CHEMSAS® R&D
collaboration

 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
9
Target:
SOX9 inhibitor
Deal terms:

CHEMSAS® R&D
Collaboration:
Western
University &
Dr. Arthur Brown

$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
10
CHEMSAS® R&D
Collaboration:
Delmar
Chemicals Inc.
(Open Innovation
Drug Discovery
Program)

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
11
Target:
Confidential

Deal terms:

CHEMSAS® R&D
Collaboration:
Multinational
Pharmaceutical
Company

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
12
Pursuing a license for our
lead oncology compound,
COTI-2

Licensing
our own
compounds

Traditional license structure
– upfront payment,
milestones, royalty
Other CHEMSAS® drug
discovery projects in queue
(i.e. AML)
13
 Effective against cancers with
mutations of the p53 gene

COTI-2:
scientific and
business
significance

 > 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
14
 5 U.S. patents granted –
strengthens value
proposition

COTI-2:
intellectual
property
overview

 Ongoing filings, with patents
pending in U.S., Europe,
Canada and Japan
 Own all intellectual property
with no license obligations

15
 In final 2-species toxicity
studies – completion
expected in first half of 2014

COTI-2:
next major
activities &
milestones

 FDA filing expected mid-2014
(leading to Phase 1 clinical trial)

 Pursuing orphan drug &/or
breakthrough therapy status
 Seeking optimal partner for
clinical development

16
Continued strong interest in
COTI-2

COTI-2:
licensing
update

Due to the novelty of the
MOA, potential partners want:
 Better understanding of
MOA
 Human data

17
COTI-2:
worldwide
license
represents
significant
revenue
potential

 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)
(2)

Medius Associates
Thomson Reuters

18
CHEMFirm

Looking
ahead:
other revenue
generating
CHEMSAS®
applications

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
19
 Programmable computer
simulation of human cancer
cell signaling

Project
ROSALIND

 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)

20
Annual &
Special
Meeting of
Shareholders
December 5, 2013

Twitter:
Follow @CriticalOutcome
Facebook:
Like CriticalOutcome
SlideShare:
Slideshare.net/CriticalOutcome
21

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Critical Outcome Technologies Business & Scientific Updates

  • 3. Disclaimer When used anywhere in this presentation, whether oral or written, the words expects, believes, anticipates, estimates and similar expressions are intended to identify forwardlooking 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. 3
  • 4. 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
  • 5. 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 5
  • 7. 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 7
  • 9.  Partner has specific novel drug target Typical CHEMSAS® R&D collaboration  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 9
  • 10. Target: SOX9 inhibitor Deal terms: CHEMSAS® R&D Collaboration: Western University & Dr. Arthur Brown $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 10
  • 11. CHEMSAS® R&D Collaboration: Delmar Chemicals Inc. (Open Innovation Drug Discovery Program) 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 11
  • 12. Target: Confidential Deal terms: CHEMSAS® R&D Collaboration: Multinational Pharmaceutical Company 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 12
  • 13. Pursuing a license for our lead oncology compound, COTI-2 Licensing our own compounds Traditional license structure – upfront payment, milestones, royalty Other CHEMSAS® drug discovery projects in queue (i.e. AML) 13
  • 14.  Effective against cancers with mutations of the p53 gene COTI-2: scientific and business significance  > 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 14
  • 15.  5 U.S. patents granted – strengthens value proposition COTI-2: intellectual property overview  Ongoing filings, with patents pending in U.S., Europe, Canada and Japan  Own all intellectual property with no license obligations 15
  • 16.  In final 2-species toxicity studies – completion expected in first half of 2014 COTI-2: next major activities & milestones  FDA filing expected mid-2014 (leading to Phase 1 clinical trial)  Pursuing orphan drug &/or breakthrough therapy status  Seeking optimal partner for clinical development 16
  • 17. Continued strong interest in COTI-2 COTI-2: licensing update Due to the novelty of the MOA, potential partners want:  Better understanding of MOA  Human data 17
  • 18. COTI-2: worldwide license represents significant revenue potential  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) (2) Medius Associates Thomson Reuters 18
  • 19. CHEMFirm Looking ahead: other revenue generating CHEMSAS® applications 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 19
  • 20.  Programmable computer simulation of human cancer cell signaling Project ROSALIND  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) 20
  • 21. Annual & Special Meeting of Shareholders December 5, 2013 Twitter: Follow @CriticalOutcome Facebook: Like CriticalOutcome SlideShare: Slideshare.net/CriticalOutcome 21