This presentation contains an overview of the scientific and business update provided by management during Critical Outcome Technologies' 2017 Annual General and Special Meeting of Shareholders on December 20, 2017.
Financial Results for the Fiscal Year Ended March 2024
2017 Annual General & Special Meeting of Shareholders
1. Advancing the Treatment of Cancer
Through Targeted Therapeutics
Annual General and Special Meeting of Shareholders
December 20, 2017
2. 2
• MEETING CALLED TO ORDER – Mr. John Drake, Chairman
• CHAIRMAN’S OPENING REMARKS
• APPOINTMENT OF THE SECRETARY FOR THE MEETING
• APPOINTMENT OF THE SCRUTINEER AND SCRUTINEER’S REPORT
• READING OF THE NOTICE OF THE MEETING
• READING OF THE MINUTES OF THE ANNUAL MEETING OF SHAREHOLDERS OF OCTOBER 13/16
• PRESENTATION OF THE FINANCIAL STATEMENTS
• FIX THE NUMBER OF DIRECTORS
• ELECTION OF THE DIRECTORS
• APPOINTMENT OF THE AUDITOR AND AUTHORITY TO FIX THEIR REMUNERATION
• APPROVAL OF THE CONTINUATION OF THE STOCK OPTION PLAN AS A ROLLING PLAN
• APPROVAL OF A CHANGE TO THE NAME OF THE COMPANY TO COTINGA PHARMACEUTICALS INC.
• APPROVAL OF A DIRECT REGISTRATION SYSTEM FOR COMMON SHARE REGISTRATION
• APPROVAL OF THE COMBINATION OF BY-LAW 1 AND BY-LAW 1A OF THE COMPANY
• OTHER BUSINESS
• MEETING TERMINATION
• BUSINESS AND SCIENTIFIC UPDATE PRESENTATION – Ms. Alison Silva, President & CEO
Meeting Agenda
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 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.
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4. 4
✓Establish and broaden US presence - Boston, MA
✓Progress COTI-2 clinical trial in gynecological malignancies
✓Broaden the potential for COTI-2 in multiple additional clinical indications
and combination therapies
✓Designate the next preclinical candidate for clinical development
✓Strengthen the balance sheet to execute on business strategy
Establish collaborations/partnerships for COTI-2 and/or other pipeline programs
and technologies
Obtain additional orphan drug designations
Recap Fiscal 2017 Corporate Objectives
5. Company and Pipeline Synopsis
Clinical stage biotech company focused on the development of novel
therapeutics for the treatment of cancers and other unmet medical needs
• Lead drug candidate is COTI-2, targeting p53
• Completed dose escalation portion of Phase 1 trial for the treatment of gynecological
malignancies
• Promising safety, tolerability, PK and PD readouts
• Initiated expansion arm of Phase 1 trial for the treatment of head and neck
squamous cell carcinoma (HNSCC)
• Second drug candidate is COTI-219, targeting KRAS
• Currently in IND-enabling studies
• IND filing expected in 2018
• Pipeline-generating CHEMSAS® platform – in silico high throughput screening
for molecule assessment
Publicly traded company
TSX-V: COT
OTCQB: COTQF
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6. Primary objectives:
Evaluate the safety and tolerability of COTI-2
• 24 patients were enrolled; half of these patients continued on treatment past cycle 1 (28
days), with a subset completing up to 4 cycles of treatment
• COTI-2 was administered at increasing dose levels between 0.25 - 1.7 mg/kg
• Most common drug-related Adverse Events (AEs) were nausea, vomiting, fatigue and abdominal
pain
Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of
COTI-2
• MTD of 1.7 mg/kg and RP2D of 1.0 mg/kg established (based on 5 days/week, oral dosing)
Secondary objectives:
Evaluate pharmacokinetics, clinical activity and response duration of COTI-2
Exploratory objectives:
Determine if baseline molecular aberrations correlate with activity of COTI-2
Evaluate pharmacodynamic markers of COTI-2 activity
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COTI-2 Phase 1 in Gynecological Malignancies Complete
7. 7
Cohort t1/2 (hr) Tmax (hr)
Cmax
(ng/mL)
AUC0-t
(ng∙hr/mL)
AUC0-∞
(ng∙hr/mL)
1 6.5 1.18 69 396 435
2 9.0 1.16 122 651 767
3 9.1 0.83 337 1489 1765
4 8.6 1.31 245 1331 1534
COTI-2 PK parameters by cohort
• Highest concentrations of COTI-2 approximately
1 hour after dosing
• T1/2 8-10 hours; substantially longer than other
treatments targeting mutant p53
• No evidence of long-term drug accumulation
• Washout in approximately one week after last
dose
COTI2: Part 1 Pharmacokinetics (PK) Data
8. December 19, 2017:
• Announced PD data and positive signals of efficacy in Phase 1 dose escalation trial in
gynecological malignancies
• Established recommended Phase 2 dose in ovarian cancer at 1.0 mg/kg orally, 5 days per week
Summary of PD data and Secondary and Exploratory Outcome Measures:
• 24 patients were enrolled with ovarian, fallopian tube, endometrial or cervical cancers for
which no effective or curative measures existed, with a median age of 60 and a median of 5
previous courses of chemotherapy
• 15 patients were evaluated for Secondary and Exploratory outcome measures, including
signals of efficacy using RECIST1 criteria.
• 11 of the 15 patients had ovarian cancer
• 12 of the 15 patients were genetically-profiled, and 9 of the 12 exhibited p53 mutations
• 1 of the 15 patients was determined to have overall stable disease
• 4 of the 15 patients were determined to have progressing disease but stable target lesions
• 5 of the 15 patients were determined to have progressing disease but stable non-target lesions
• 1 patient was observed to have a decrease in Cancer Antigen-125 (CA-125) levels in her blood
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COTI2: Part 1 Pharmacodynamics (PD) Data
In patients with gynecological malignancies
1 Eisenhauer et al, 2009. European Journal of Cancer: 45; 228-247
9. COTI-2: Part 2 Trial in Head and Neck Cancers Initiated
COTI-2 Phase 1 Head and Neck Squamous Cell Carcinoma (HNSCC) trial:
• Clinical trial site – MD Anderson Cancer Center
• Initial safety and tolerability trial initiated: first cohort started at 1.0 mg/kg
• Primary (cohorts 1-2) readout expected in Q2 2018
HNSCC:
• ~65,000 patients are diagnosed with HNSCC per year; disease predominantly
affects men, with approximately 447,000 patients identified (US)
• ~40-50% HNSCC is associated with mutant p53
• Current treatments include surgery, radiotherapy and chemotherapy
• Approximately 13,000 deaths from HNSCC in the US per year, representing a
clear unmet need for additional treatment options
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10. Pre-clinical Efficacy Data Supporting Additional
COTI-2 Indication: Head and Neck Cancers
• COTI-2, whether as a single agent (75 mg/kg PO) or in combination with radiation, produced
tumor growth inhibition relative to untreated controls in PCI13 pG245D, the p53-mutated head and
neck cancer cell line
• COTI-2 + radiation (2 Gy) has better tumor suppression and tumor cure effect compared with COTI-2 or radiation alone
• Tumor growth regression was as follows: COTI-2 alone (1/6), radiation alone (1/6), COTI-2 + radiation (4/7)
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11. 11
2017 2018 2019
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Part 1
1.0 mg/kg
Ovarian
HNSCC
HNSCC + Radiotherapy
Part 1: Dose escalation
phase of gynecological
cancers trial (started Feb
‘16)
Part 3: Single dose level expansion trials
Parts 1-3:
CSR filing
Part 1:
Initial safety
read-out
Part 1: Full
interim
analysis
Expected populations: colorectal, pancreatic, breast and small cell lung cancers
COTI-2 Phase 2 basket study
Basket study
initial read-out
Part 2: Dose escalation
phase of HNSCC trial
Part 3: Mid-
recruitment
read-out
Part 2:
Initial safety
read-out
1.7 mg/kg
COTI-2 Program Timeline
projected timeline based on available clinical data
Part 1: Initial
PK read-out
12. 12
Corporate/Finance:
• Strengthenthe balancesheet to fundoperationsthroughcalendar2018
COTI-2:
• Complete Phase 1 clinical trial in gynecological malignancies
✓ Completed dose escalation Phase 1 trial
✓ Completed primary and secondary endpoints
• Complete exploratory endpoints in Q1 2018
• Broaden the clinical landscape of COTI-2 in HNSCC
✓ Initiated the dose escalation Phase 1 trial
• Initiate combination trials with COTI-2 (with radiation in HNSCC patients)
• Opportunistically pursue regional or co-development partnerships for COTI-2 or pipeline
programs/technologies
COTI-219:
• Complete GMP manufacturing and IND enabling studies for COTI-219
Fiscal 2018 Corporate Goals
13. 2017 Financing
✓ Completed $2.1M CAD private
placement in October 2017
2017 Financing Use of Proceeds
Initiation of HNSCC dose escalation
COTI-2 trial
✓ Analysis of data from COTI-2 trial in
gynecological malignancies
• Conduct further preclinical studies
with COTI-219 (in process)
UPCOMING
Calendar 4Q17 Financing
✓ US investment bank engaged as exclusive
placement agents for US equity raise
• Single transaction
• Target $5M USD
Financing Use of Proceeds
• Completion of HNSCC dose escalation trial
• Completion of expansion trials with COTI-2
(single dose level of COTI-2 in HNSCC (+/-
radiotherapy) and in ovarian cancer)
• Initiation of p53 basket trial
• Perform COTI-219 preclinical work enabling an
IND submission
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COMPLETED
Financing Objectives Q4 2017 – Q1 2018
14. Introducing Cotinga Pharma!
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New brand signifies evolution from
a technology-driven company to
a clinical-stage pharmaceutical company
Name selection maintains consistent:
Stock symbols
TSX-V: COT
OTCQB: COTQF
Product nomenclature
COTI-2
COTI-219
Updated website
www.cotingapharma.com
will be available in January 2018
“Cotinga” refers to a diverse bird
species in South & Central America
For Cotinga Pharmaceuticals, it symbolizes
the potential for our cancer therapeutics to
treat a wide spectrum of cancer patients
15. Leadership Team
MANAGEMENT TEAM
Alison Silva, MSc
• President & CEO
• Co-founder, former EVP & COO, Synlogic
• Co-founder & Principal, The Orphan Group
Richard Ho, MD, PhD
• Chief Scientific Officer
• Former, EVP R&D, Marina Biotech
• Former, Director, Disease Simulation, J&J PRD
Gene Kelly
• Chief Financial Officer
Kowthar Salim, PhD, MBA
• Vice President, Development
Debi Sanderson, MBA
• Director, Resourcing and Operations
DIRECTORS
John Drake, LLB, Chairman
• Chairman, Whippoorwill Holdings
Limited
Alison Silva, MSc, President & CEO
Douglas Alexander, CPA, CA
• Chairman, Hydrogenics Corporation
Dave Sanderson, LLB
• President, Red Jacket Capital Inc.
John Yoo, MD FRCPC
• Professor, Chairman and City-wide
Chief of Otolaryngology – Head and
Neck Surgery at Western University
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