Pathway to the clinic and beyond

Pathway to the clinic … and beyond

Study design

October 2014

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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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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

Recent milestones

Orphan Drug Designation

MD Anderson Cancer Center

Additional patents

FDA meeting request

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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

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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

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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

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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

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Formal pre-IND meeting request submitted to FDA

Our questions to FDA focused on:

Chemistry manufacturing of final drug product for Phase 1

Proposed clinical trial protocol, inclusion/exclusion criteria, informed consent etc.

Response from FDA expected first week in November

If no issues identified we can submit IND package

FDA meeting request

Next steps

IND filing

First patient enrolment

Phase 1 completion

Out-license vs Phase 2

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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

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Earliest first patient enrolment in February/March 2015

Depends on MDACC, State of Texas and U.S. Federal approval

Requires COTI-2 commitment to pay USD 1.25 million

According to MDACC many patients available / waiting

First patient enrollment

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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

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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

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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

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Many other indications with p53 mutations are being explored including combination therapy

COTI-2 revenue potential

Beyond COTI-2

Drugs in our pipeline

R&D collaborations

Other applications

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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

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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

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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

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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

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COTI-2 in the clinic in 2015

COTI-2 = significant revenue potential

Pipeline of other revenue opportunities

Reaching a tipping point

Pathway to the clinic … and beyond

Study design