SlideShare una empresa de Scribd logo
1 de 15
Descargar para leer sin conexión
Advancing the Treatment of Cancer
Through Targeted Therapeutics
Annual General and Special Meeting of Shareholders
December 20, 2017
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
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.
3
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
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
5
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
6
COTI-2 Phase 1 in Gynecological Malignancies Complete
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
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
8
COTI2: Part 1 Pharmacodynamics (PD) Data
In patients with gynecological malignancies
1 Eisenhauer et al, 2009. European Journal of Cancer: 45; 228-247
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
9
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)
10
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
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
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
13
COMPLETED
Financing Objectives Q4 2017 – Q1 2018
Introducing Cotinga Pharma!
14
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
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
15

Más contenido relacionado

La actualidad más candente

E2 e guideline
E2 e guidelineE2 e guideline
E2 e guideline
nani ch
 
Ctd triangle
Ctd triangleCtd triangle
Ctd triangle
moulai
 

La actualidad más candente (20)

Regulations, guidelines & ethics in clinical research
Regulations, guidelines & ethics in clinical researchRegulations, guidelines & ethics in clinical research
Regulations, guidelines & ethics in clinical research
 
CTD and E-CTD Regulatory Affairs
CTD and E-CTD Regulatory AffairsCTD and E-CTD Regulatory Affairs
CTD and E-CTD Regulatory Affairs
 
E2 e guideline
E2 e guidelineE2 e guideline
E2 e guideline
 
ICH GUIDELINES MULTIDISCIPLINARY
ICH GUIDELINES MULTIDISCIPLINARYICH GUIDELINES MULTIDISCIPLINARY
ICH GUIDELINES MULTIDISCIPLINARY
 
importance of pharmcovigilance
importance of pharmcovigilanceimportance of pharmcovigilance
importance of pharmcovigilance
 
Ch. 4 drug stability
Ch. 4 drug stabilityCh. 4 drug stability
Ch. 4 drug stability
 
Who
WhoWho
Who
 
ICH Safety Guidelines
ICH Safety GuidelinesICH Safety Guidelines
ICH Safety Guidelines
 
Ctd triangle
Ctd triangleCtd triangle
Ctd triangle
 
Repurposed drugs and safety monitoring
Repurposed drugs and safety monitoring Repurposed drugs and safety monitoring
Repurposed drugs and safety monitoring
 
History of Pharmacovigilance
History of PharmacovigilanceHistory of Pharmacovigilance
History of Pharmacovigilance
 
Ich guidelines for quality assurence
Ich guidelines for quality assurenceIch guidelines for quality assurence
Ich guidelines for quality assurence
 
GOOD PHARMACOVIGILANCE PRACTICES
GOOD PHARMACOVIGILANCE PRACTICESGOOD PHARMACOVIGILANCE PRACTICES
GOOD PHARMACOVIGILANCE PRACTICES
 
Biologicals Update
Biologicals UpdateBiologicals Update
Biologicals Update
 
Drug Approval Bodies in Canada 101: The Elevator Length Pitch
Drug Approval Bodies in Canada 101: The Elevator Length PitchDrug Approval Bodies in Canada 101: The Elevator Length Pitch
Drug Approval Bodies in Canada 101: The Elevator Length Pitch
 
Safety Data Generation
Safety Data GenerationSafety Data Generation
Safety Data Generation
 
History n progress of pv
History n progress of pvHistory n progress of pv
History n progress of pv
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Drug Information Association Clinical Forum Presentation
Drug Information Association Clinical Forum PresentationDrug Information Association Clinical Forum Presentation
Drug Information Association Clinical Forum Presentation
 

Similar a 2017 Annual General & Special Meeting of Shareholders

2017 01 04 corporate presentation
2017 01 04 corporate presentation2017 01 04 corporate presentation
2017 01 04 corporate presentation
Kristine Mechem
 
Corporate Presentation TiGenix - September 2014
Corporate Presentation TiGenix - September 2014Corporate Presentation TiGenix - September 2014
Corporate Presentation TiGenix - September 2014
TiGenix
 

Similar a 2017 Annual General & Special Meeting of Shareholders (20)

COTI Corporate Presentation at Cantech 2017
COTI Corporate Presentation at Cantech 2017COTI Corporate Presentation at Cantech 2017
COTI Corporate Presentation at Cantech 2017
 
Can Fite Investor Presentation Dec 2022
Can Fite Investor Presentation Dec 2022Can Fite Investor Presentation Dec 2022
Can Fite Investor Presentation Dec 2022
 
Dr. Hager 2016 Presentation The Challenges of Achieving Early Efficacy in Cli...
Dr. Hager 2016 Presentation The Challenges of Achieving Early Efficacy in Cli...Dr. Hager 2016 Presentation The Challenges of Achieving Early Efficacy in Cli...
Dr. Hager 2016 Presentation The Challenges of Achieving Early Efficacy in Cli...
 
Galt 5232013
Galt 5232013Galt 5232013
Galt 5232013
 
Can Fite Investor Presentation August 2022
Can Fite Investor Presentation August 2022Can Fite Investor Presentation August 2022
Can Fite Investor Presentation August 2022
 
Pathway to the clinic and beyond
Pathway to the clinic and beyondPathway to the clinic and beyond
Pathway to the clinic and beyond
 
Can Fite Investor Presentation June 2022
Can Fite Investor Presentation June 2022Can Fite Investor Presentation June 2022
Can Fite Investor Presentation June 2022
 
1810 3 q-2018-presentation-v7
1810 3 q-2018-presentation-v71810 3 q-2018-presentation-v7
1810 3 q-2018-presentation-v7
 
2017 01 04 corporate presentation
2017 01 04 corporate presentation2017 01 04 corporate presentation
2017 01 04 corporate presentation
 
Galt
GaltGalt
Galt
 
2016 Annual General & Special Meeting of Shareholders
2016 Annual General & Special Meeting of Shareholders2016 Annual General & Special Meeting of Shareholders
2016 Annual General & Special Meeting of Shareholders
 
Driving innovation procurement forward International Perspective: What can we...
Driving innovation procurement forward International Perspective: What can we...Driving innovation procurement forward International Perspective: What can we...
Driving innovation procurement forward International Perspective: What can we...
 
Business and Scientific Update
Business and Scientific UpdateBusiness and Scientific Update
Business and Scientific Update
 
Q2, 2016 earnings slides final2
Q2, 2016 earnings slides   final2Q2, 2016 earnings slides   final2
Q2, 2016 earnings slides final2
 
Q2, 2016 earnings slides final2
Q2, 2016 earnings slides   final2Q2, 2016 earnings slides   final2
Q2, 2016 earnings slides final2
 
CLBS Corporate Slide Presentation March 2018
CLBS Corporate Slide Presentation March 2018CLBS Corporate Slide Presentation March 2018
CLBS Corporate Slide Presentation March 2018
 
A promising advance for many cancers
A promising advance for many cancersA promising advance for many cancers
A promising advance for many cancers
 
Small-Cap Stars
Small-Cap StarsSmall-Cap Stars
Small-Cap Stars
 
Overview of Global Regulatory Affairs for Gene Therapy 2019
Overview of Global Regulatory Affairs for Gene Therapy 2019Overview of Global Regulatory Affairs for Gene Therapy 2019
Overview of Global Regulatory Affairs for Gene Therapy 2019
 
Corporate Presentation TiGenix - September 2014
Corporate Presentation TiGenix - September 2014Corporate Presentation TiGenix - September 2014
Corporate Presentation TiGenix - September 2014
 

Más de Critical Outcome Technologies Inc.

Más de Critical Outcome Technologies Inc. (15)

COTI Overview
COTI OverviewCOTI Overview
COTI Overview
 
COTI-2 Fact Sheet
COTI-2 Fact SheetCOTI-2 Fact Sheet
COTI-2 Fact Sheet
 
Introducing ROSALIND
Introducing ROSALINDIntroducing ROSALIND
Introducing ROSALIND
 
Critical Outcome investor presentation - November 2015
Critical Outcome investor presentation - November 2015Critical Outcome investor presentation - November 2015
Critical Outcome investor presentation - November 2015
 
More than just a potential BREAKTHROUGH treatment for many cancers
More than just a potential BREAKTHROUGH treatment for many cancersMore than just a potential BREAKTHROUGH treatment for many cancers
More than just a potential BREAKTHROUGH treatment for many cancers
 
Critical Outcome Technologies at the BIO Investor Forum 2014
Critical Outcome Technologies at the BIO Investor Forum 2014Critical Outcome Technologies at the BIO Investor Forum 2014
Critical Outcome Technologies at the BIO Investor Forum 2014
 
Critical Outcome - September 2014
Critical Outcome - September 2014Critical Outcome - September 2014
Critical Outcome - September 2014
 
Introducing ROSALIND
Introducing ROSALINDIntroducing ROSALIND
Introducing ROSALIND
 
COTI-2 | Reactivating Mutant p53
COTI-2 | Reactivating Mutant p53COTI-2 | Reactivating Mutant p53
COTI-2 | Reactivating Mutant p53
 
Critical Outcome Technologies - May 2014
Critical Outcome Technologies - May 2014Critical Outcome Technologies - May 2014
Critical Outcome Technologies - May 2014
 
Critical Outcome Investor Presentation - March 2014
Critical Outcome Investor Presentation - March 2014Critical Outcome Investor Presentation - March 2014
Critical Outcome Investor Presentation - March 2014
 
Critical Outcome - Investor Presentation - January 2014
Critical Outcome - Investor Presentation - January 2014Critical Outcome - Investor Presentation - January 2014
Critical Outcome - Investor Presentation - January 2014
 
Critical Outcome Technologies Business & Scientific Updates
Critical Outcome Technologies Business & Scientific UpdatesCritical Outcome Technologies Business & Scientific Updates
Critical Outcome Technologies Business & Scientific Updates
 
Critical Outcome BIO Investor Forum
Critical Outcome BIO Investor ForumCritical Outcome BIO Investor Forum
Critical Outcome BIO Investor Forum
 
Critical Outcome Technologies - Investor Presentation - June 2013
Critical Outcome Technologies - Investor Presentation - June 2013Critical Outcome Technologies - Investor Presentation - June 2013
Critical Outcome Technologies - Investor Presentation - June 2013
 

Último

Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
mriyagarg453
 
💚😋 Saharanpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
💚😋 Saharanpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋💚😋 Saharanpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
💚😋 Saharanpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
nirzagarg
 
💚😋 jamshedpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
💚😋 jamshedpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋💚😋 jamshedpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
💚😋 jamshedpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
nirzagarg
 
VIP Call Girls Junagadh 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Junagadh 7001035870 Whatsapp Number, 24/07 BookingVIP Call Girls Junagadh 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Junagadh 7001035870 Whatsapp Number, 24/07 Booking
dharasingh5698
 
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 BookingVIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
dharasingh5698
 
Editing progress 20th march.docxxxxxxxxx
Editing progress 20th march.docxxxxxxxxxEditing progress 20th march.docxxxxxxxxx
Editing progress 20th march.docxxxxxxxxx
MollyBrown86
 
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort ServiceCall Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
9953056974 Low Rate Call Girls In Saket, Delhi NCR
 

Último (20)

Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
 
💚😋 Saharanpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
💚😋 Saharanpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋💚😋 Saharanpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
💚😋 Saharanpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
 
💚😋 jamshedpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
💚😋 jamshedpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋💚😋 jamshedpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
💚😋 jamshedpur Escort Service Call Girls, 9352852248 ₹5000 To 25K With AC💚😋
 
The Leonardo 1Q 2024 Results Presentation
The Leonardo 1Q 2024 Results PresentationThe Leonardo 1Q 2024 Results Presentation
The Leonardo 1Q 2024 Results Presentation
 
Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...
Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...
Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...
 
SME IPO Opportunity and Trends of May 2024
SME IPO Opportunity and Trends of May 2024SME IPO Opportunity and Trends of May 2024
SME IPO Opportunity and Trends of May 2024
 
ITAU EQUITY_STRATEGY_WARM_UP_20240505 DHG.pdf
ITAU EQUITY_STRATEGY_WARM_UP_20240505 DHG.pdfITAU EQUITY_STRATEGY_WARM_UP_20240505 DHG.pdf
ITAU EQUITY_STRATEGY_WARM_UP_20240505 DHG.pdf
 
Western Copper and Gold - May 2024 Presentation
Western Copper and Gold - May 2024 PresentationWestern Copper and Gold - May 2024 Presentation
Western Copper and Gold - May 2024 Presentation
 
VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...
VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...
VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...
 
Teekay Tankers Q1-24 Earnings Presentation
Teekay Tankers Q1-24 Earnings PresentationTeekay Tankers Q1-24 Earnings Presentation
Teekay Tankers Q1-24 Earnings Presentation
 
Teck Supplemental Information, May 2, 2024
Teck Supplemental Information, May 2, 2024Teck Supplemental Information, May 2, 2024
Teck Supplemental Information, May 2, 2024
 
VIP Call Girls Junagadh 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Junagadh 7001035870 Whatsapp Number, 24/07 BookingVIP Call Girls Junagadh 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Junagadh 7001035870 Whatsapp Number, 24/07 Booking
 
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 BookingVIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
 
Dattawadi ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready Fo...
Dattawadi ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready Fo...Dattawadi ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready Fo...
Dattawadi ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready Fo...
 
Editing progress 20th march.docxxxxxxxxx
Editing progress 20th march.docxxxxxxxxxEditing progress 20th march.docxxxxxxxxx
Editing progress 20th march.docxxxxxxxxx
 
High Profile Call Girls in Pune (Adult Only) 8005736733 Escort Service 24x7 ...
High Profile Call Girls in Pune  (Adult Only) 8005736733 Escort Service 24x7 ...High Profile Call Girls in Pune  (Adult Only) 8005736733 Escort Service 24x7 ...
High Profile Call Girls in Pune (Adult Only) 8005736733 Escort Service 24x7 ...
 
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
 
Best investment platform in india-Falcon Invoice Discounting
Best investment platform in india-Falcon Invoice DiscountingBest investment platform in india-Falcon Invoice Discounting
Best investment platform in india-Falcon Invoice Discounting
 
countries with the highest gold reserves in 2024
countries with the highest gold reserves in 2024countries with the highest gold reserves in 2024
countries with the highest gold reserves in 2024
 
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort ServiceCall Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
 

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. 3
  • 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 5
  • 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 6 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 8 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 9
  • 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) 10
  • 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 13 COMPLETED Financing Objectives Q4 2017 – Q1 2018
  • 14. Introducing Cotinga Pharma! 14 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 15