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Business and Scientific Update
2
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
3
2015 Strategic Goals
2
3
4
1
5
Obtain Investigational New Drug (IND) Status
for COTI-2 from the US FDA
Increase value of COTI-2 by identifying new clinical
trial indications and combination therapies
Appoint Scientific Advisory Board for the clinical
development of COTI-2 & other pipeline assets
Commence Phase 1 clinical trial for COTI-2 in
patients with advanced gynecologic cancers
Select our next clinical candidate for
development
4
April 2015
#1: IND Status for COTI-2
Filed our IND application
May 2015
IND status granted by U.S. Food and
Drug Administration for COTI-2 in
gynecologic cancers
5
 Exploring clinical trials for other indications:
 Head and neck (orphan) 2016
 Li-Fraumeni syndrome (orphan) 2016
 AML (orphan)
 NSCLC
 COTI-2 effective when combined with many
first line therapies:
 Chemotherapy
 Immunotherapy – actively developing research
collaborations
#2:Identify New Indications/Comb.Therapies
6
#3: Establish Scientific Advisory Board
March 2015
Established high-profile Scientific
Advisory Board for the clinical
development of COTI-2 and other
pipeline assets
Chaired by Dr. Gordon Mills
7
#4: Commence Phase 1 for COTI-2
 Expected to commence October 2015 at MDACC
 Up to 46 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 ~ 9 months into the study
8
#5: Select Next Candidate for Development
Options are:
1. COTI-219, a unique oncology drug candidate for CRC
and other cancers with RAS mutations
2. COTI-AML-01, a multi-kinase inhibitor for Acute
Myelogenous Leukemia (AML)
3. COTI-HIV-II, second generation dual HIV Integrase
inhibitor
4. COTI-MRSA1, highly novel antibiotic program
All potential candidates discovered by
our CHEMSAS® platform
9
Compound Target CHEMSAS® Lead
Selection
Synthesis Preclinical Phase 1
COTI-2 (p53)
AML
Colon
COTI-219
COTI-4
COTI-58
Other Programs*
*Programs for MRSA, Multiple sclerosis, Alzheimer’s, and HIV Integrase
CHEMSAS: Our Pipeline
10
COTI-2
A potential breakthrough
therapy for many cancers
11
P53-dependent mechanism of action
 Demonstrated selective
and potent anti-cancer
activity in pre-clinical
experiments
 Effective against many
common cancers with a
p53 gene mutation
 > 50% of all human cancers
have a p53 mutation
(e.g. ~ 95% of serous ovarian
cancers)
“a promisingadvance” for
many cancers with p53
mutations.”–Dr.G.B.Mills,MDACC
12
Tumors significantly reduced by COTI-2 in all
treatment groups relative to vehicle control
COTI-2: Impressive single agent activity
13
Orphan Drug Designation
 Granted by the FDA for the treatment of ovarian
cancer – June 2014
 Potentially qualifies us for:
 Assistance in clinical trial design
 Expedited drug development – Fast track designation
 Development grants & fee reductions
 7-year exclusive marketing period
14
 Orally bio-available and effective at low dose
 Low toxicity in preclinical development
 Opportunity for both single agent and combination
therapy
 Strong US and international IP protection in place
Other COTI-2 Highlights
15
Out-license vs Phase 2
Positive Phase 1 results will 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
16
Shareholder value creation 2015
COTI share price performance compared with TSX.V
~60% above market performance
17
Strategic goals for
2016
18
1
2
3
Guide COTI-2 to successful completion of
first Phase 1 human trial and licensing deal
Identify and commence at least one
additional Phase 1 clinical trial in 2016
Identify our next clinical candidate and
drive it towards the clinic
2016 Strategic Goals
4 Plan for strategic growth in the US
- Boston based office
- Uplift to NASDAQ listing
2015 Annual General and Special
Meeting of Shareholders
Thank you

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Business and Scientific Update

  • 2. 2 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
  • 3. 3 2015 Strategic Goals 2 3 4 1 5 Obtain Investigational New Drug (IND) Status for COTI-2 from the US FDA Increase value of COTI-2 by identifying new clinical trial indications and combination therapies Appoint Scientific Advisory Board for the clinical development of COTI-2 & other pipeline assets Commence Phase 1 clinical trial for COTI-2 in patients with advanced gynecologic cancers Select our next clinical candidate for development
  • 4. 4 April 2015 #1: IND Status for COTI-2 Filed our IND application May 2015 IND status granted by U.S. Food and Drug Administration for COTI-2 in gynecologic cancers
  • 5. 5  Exploring clinical trials for other indications:  Head and neck (orphan) 2016  Li-Fraumeni syndrome (orphan) 2016  AML (orphan)  NSCLC  COTI-2 effective when combined with many first line therapies:  Chemotherapy  Immunotherapy – actively developing research collaborations #2:Identify New Indications/Comb.Therapies
  • 6. 6 #3: Establish Scientific Advisory Board March 2015 Established high-profile Scientific Advisory Board for the clinical development of COTI-2 and other pipeline assets Chaired by Dr. Gordon Mills
  • 7. 7 #4: Commence Phase 1 for COTI-2  Expected to commence October 2015 at MDACC  Up to 46 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 ~ 9 months into the study
  • 8. 8 #5: Select Next Candidate for Development Options are: 1. COTI-219, a unique oncology drug candidate for CRC and other cancers with RAS mutations 2. COTI-AML-01, a multi-kinase inhibitor for Acute Myelogenous Leukemia (AML) 3. COTI-HIV-II, second generation dual HIV Integrase inhibitor 4. COTI-MRSA1, highly novel antibiotic program All potential candidates discovered by our CHEMSAS® platform
  • 9. 9 Compound Target CHEMSAS® Lead Selection Synthesis Preclinical Phase 1 COTI-2 (p53) AML Colon COTI-219 COTI-4 COTI-58 Other Programs* *Programs for MRSA, Multiple sclerosis, Alzheimer’s, and HIV Integrase CHEMSAS: Our Pipeline
  • 11. 11 P53-dependent mechanism of action  Demonstrated selective and potent anti-cancer activity in pre-clinical experiments  Effective against many common cancers with a p53 gene mutation  > 50% of all human cancers have a p53 mutation (e.g. ~ 95% of serous ovarian cancers) “a promisingadvance” for many cancers with p53 mutations.”–Dr.G.B.Mills,MDACC
  • 12. 12 Tumors significantly reduced by COTI-2 in all treatment groups relative to vehicle control COTI-2: Impressive single agent activity
  • 13. 13 Orphan Drug Designation  Granted by the FDA for the treatment of ovarian cancer – June 2014  Potentially qualifies us for:  Assistance in clinical trial design  Expedited drug development – Fast track designation  Development grants & fee reductions  7-year exclusive marketing period
  • 14. 14  Orally bio-available and effective at low dose  Low toxicity in preclinical development  Opportunity for both single agent and combination therapy  Strong US and international IP protection in place Other COTI-2 Highlights
  • 15. 15 Out-license vs Phase 2 Positive Phase 1 results will 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
  • 16. 16 Shareholder value creation 2015 COTI share price performance compared with TSX.V ~60% above market performance
  • 18. 18 1 2 3 Guide COTI-2 to successful completion of first Phase 1 human trial and licensing deal Identify and commence at least one additional Phase 1 clinical trial in 2016 Identify our next clinical candidate and drive it towards the clinic 2016 Strategic Goals 4 Plan for strategic growth in the US - Boston based office - Uplift to NASDAQ listing
  • 19. 2015 Annual General and Special Meeting of Shareholders Thank you