COTI Corporate Presentation at Cantech 2017
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Transcript of COTI Corporate Presentation at Cantech 2017
Advancing the Treatment of Cancer
Through Targeted Therapeutics
January 2017
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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 addressingfuture financial and operating results of Critical Outcome Technologies Inc. (COTI).
COTI bases these forward-looking statements on its current expectations about futureevents. Such statements are subject to risks and uncertainties including, but not limitedto, the successful implementation of COTI’s strategic plans, the acceptance of newproducts, the obsolescence of existing products, the resolution of potential patentissues, competition, changes in economic conditions, and other risks described in COTI’spublic documents such as press releases and filings with the Toronto Stock Exchange andthe Ontario Securities Commission.
All forward-looking statements are qualified in their entirety by the cautionarystatements included in this document and such filings. These risks and uncertaintiescould cause actual results to differ materially from results expressed or implied byforward-looking statements contained in this presentation. These forward-lookingstatements speak only as of the date of this presentation.
Disclaimer
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• Clinical stage biotech company focused on the development of novel therapeutics for the treatment of cancers and other unmet medical needs
• Pipeline of internally developed compounds
• CHEMSAS platform – in silico high throughput screening for molecule identification
• ROSALIND technology – genomics profiling for personalized oncology care
• Offices in London, ON and Boston, MA
TSX-V: COT
OTCQB: COTQF
Company and Pipeline Synopsis
• In response to cellular stress, wild-type p53 induces cell cycle arrest and/or apoptotic cell death
• Mutant p53 promotes tumor formation (loss of tumor suppressor function)– Mutant p53: single most important cancer-causing gene mutation known– >50% of all human cancers– Most frequently mutated gene in human cancer with frequencies ranging from
38% to 96%
• COTI-2 induces a wild-type-like conformational change in the p53 mutant protein that restores sequence-specific p53 transcription– Oral small molecule– Low preclinical toxicity– Active as a mono or combination therapy– Currently in a Phase I trial in gynecological malignancies
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COTI-2 Mechanism of Action & Synopsis
mutp53mutp53
Sequence-specific transactivation defective
Conformational change to a wild-type configuration
Restoration of sequence-specific transcriptional activity
Apoptosis, growth arrest, senescence
mutp53
Drug Drug
5
0
50
100
150
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0 5 9 16 23 30 37 44 51 61
Tum
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lum
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mm
3 )
Study Day
Effect of IV Treatment on OVCAR-3 Tumor Volume
Group 1 = Vehicle IV
Group 2 = COTI-2 20mg/kg IV
Group 3 = COTI-2 40mg/kg IV
0
50
100
150
200
250
0 5 9 16 23 30 37 44 51 61
Tum
or
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mm
3 )
Study Day
Effect of PO Treatment on OVCAR-3 Tumor Volume
Group 4 = Vehicle PO
Group 5 = COTI-2 75mg/kg PO
Group 6 = COTI-2 100mg/kg PO
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James Koropatnick, LRCC, London, ON.
Significant Tumor Growth Inhibition as a Single Agent
• COTI-2 administered IV and PO produced a significant tumor growth inhibition as a single agent in an OVCAR-3 ovarian cancer xenograft model
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• COTI-2 as a single agent and in combination with cisplatin produced significant tumor growth inhibition relative to untreated controls in the PCI13 pG245D head and neck cancer xenograft models
• Cisplatin treatment alone did not yield significant tumor growth inhibition
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Jeffrey Myers, U of Texas, MDACC, Houston, TX.
Significant Tumor Growth Inhibition in Combination with Cisplatin
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Protocol Title
A PHASE 1 STUDY OF COTI-2 FOR THE TREATMENT OF ADVANCED OR RECURRENT GYNECOLOGIC MALIGNANCIES
Study Sites MD Anderson Cancer Center, Houston, TX Northwestern University Memorial Hospital, Chicago, IL
Principal Investigators
Dr. Shannon Westin Dr. Wilberto Neives-Niera
Study Phase Phase 1
Objective Primary• To evaluate the safety and tolerability of COTI-2 in patients with advanced or recurrent gynecologic malignancies.• To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of COTI-2 for the
treatment of patients with advanced or recurrent gynecologic malignancies.
Secondary• To evaluate the pharmacokinetics of COTI-2 at all dose levels in patients with advanced or recurrent gynecologic
malignancies.• To estimate the clinical activity of COTI-2 at all dose levels and the RP2D in patients with advanced or recurrent
gynecologic malignancies by response rate (Response Evaluation Criteria In Solid Tumors [RECIST] v1.1 criteria) and the progression-free survival (PFS) rate at 6 months.
• To estimate the response duration for COTI-2 at all dose levels and the RP2D in patients with advanced or recurrent gynecologic malignancies.
Exploratory• To determine if baseline molecular aberrations, including p53 mutation, correlate with activity of COTI-2 in advanced
or recurrent gynecologic malignancies.• To evaluate pharmacodynamic markers of COTI-2 activity at all dose levels and at the RP2D in patients with advanced
or recurrent gynecologic malignancies.
Patient Population
• Females with ovarian, fallopian tube, primary peritoneal, endometrial or cervical cancer that is recurrent, metastatic, or unresectable and for which no effective or curative measures exist
Sample Size • Maximum 46 patients • Dose Escalation Phase: up to 36 patients (up to 6 cohorts)
• Dose Expansion Phase: 10 patients with ovarian cancer (one cohort)
COTI2-101 Study Summary
• Regular updates will be provided as each cohort commences dosing, with Cohort 4 announced in January 2017
– Announcement of dose escalation is the only “releasable” information during this clinical phase
• June 2017 – preliminary results on the safety and clinical activity of COTI-2
• Other trials planned in 2017 – additional multi center clinical trial programs:
– Recurrent Head and Neck Squamous Cell cancer (HNSCC)
– Soft tissue sarcoma (STS)
– Combination trials with other chemo/radiotherapies
• Final trial results and conclusions
– Mid 2017 - gynecological phase
– Late 2017 - expansion phase
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Anticipated COTI2-101 Clinical Trial News Flow
• Novel and specific p53-dependent mechanism of action
• Orally bio-available and effective at low dose
• Low toxicity in preclinical development
• Opportunity for single agent and combination therapy
• No drug resistance observed
• Sensitization to radiation therapy
• Strong IP protection in place
- 8 U.S. patents issued
- 1 Japanese, 1 Canadian and 1 EU patent issued
- Additional patents pending
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COTI-2 Best-in-Class Potential
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CORPORATE
Appointed experienced Scientific Advisory Board (SAB)
Opened US office (Boston, MA) in Aug 2016
Designated next preclinical candidate for clinical development
COTI-2
Granted FDA orphan drug status for ovarian cancer
Received IND granting
Filed for FDA orphan drug status for Li-Fraumenisyndrome
Published first scientific article in Oncotargets
Commenced patient dosing of Phase 1 clinical trial at MDACC
Activated second clinical trial site at NWU
Initiated fourth patient cohort of Phase 1 clinical trial
COMPLETED UPCOMING
CORPORATE
• Strengthen the balance sheet to execute on corporate strategies
• Establish collaborations/partnerships for COTI-2, pipeline programs and other technologies
COTI-2
• Broaden the potential for COTI-2 in multiple additional clinical indications and combination therapies
• Obtain additional orphan drug designations
COTI-219
• Continue IND-enabling studies
• File an IND by the end of 2017
Corporate Objectives
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Management Team Directors
Alison Silva, MSc• President & CEO• Co-founder, former EVP & COO, Synlogic• Co-founder & Principal, The Orphan Group
Wayne Danter, MD, FRCPC• Co-founder & CSO • Former Associate Professor of Medicine at
Western University
Gene Kelly• Chief Financial Officer• Former VP Finance, Cuddy Farms
Debi Sanderson, MBA• Director, Resourcing and Operations
Kowthar Salim, PhD, MBA• Program Director and Senior Scientist
John Drake, LLB, Chairman• Chairman, Whippoorwill Holdings Limited
Alison Silva, MSc, President & CEO
Wayne Danter, MD, FRCPC, Co-founder & CSO
Douglas Alexander, CPA, CA• Chairman, Hydrogenics Corporation
Bruno Maruzzo, MASc, MBA• President, TechnoVenture Inc.
Dave Sanderson, LLB• President & CEO, KFL Investment
Management Inc.
John Yoo, MD FRCPC• Professor, Chairman and City-wide Chief of
Otolaryngology – Head and Neck Surgery at Western University
Bharatt Chowrira, PhD, JD• President, Synlogic
Committed Leadership
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Key Company Facts
Trading
TSX Venture (2) COT
Recent Closing Price (3) $0.475
52 Week Range (3) $0.21 - 0.90
Market Capitalization (3) $70,850,257
Capital
Cash (4) $3.56 M
Basic Shares Outstanding (3) 149,158,435
Options Outstanding (3) 11,197,435
Warrants Outstanding (3) 22,163,113
Fully Diluted Shares Outstanding (3) 182,518,983
Board & management control (3) (5) 16.3%
(1) All $ amounts in CAD(2) COTI also trades on the OTCQB as COTQF but amounts
are for the TSXV only(3) As of the close of business Dec 31, 2016(4) As at Dec 31, 2016 consisting of cash, cash equivalents and investments(5) On a fully diluted basis
Contact:Alison SilvaPresident & CEOOffice: (519) 858-5157Mobile: (860) [email protected]
www.criticaloutcome.comwww.criticaloutcomeblog.comwww.facebook.com/criticaloutcometwitter.com/criticaloutcomewww.slideshare.net/criticaloutcome