Critical Outcome Technologies Business & Scientific Updates

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Annual & Special Meeting of Shareholders December 5, 2013

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Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.

Transcript of Critical Outcome Technologies Business & Scientific Updates

Page 1: Critical Outcome Technologies Business & Scientific Updates

Annual & Special Meeting of Shareholders December 5, 2013

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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

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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)

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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

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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

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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

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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

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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)

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Annual & Special Meeting of Shareholders December 5, 2013

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