COTI Corporate Presentation at Cantech 2017

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Advancing the Treatment of Cancer Through Targeted Therapeutics January 2017

Transcript of COTI Corporate Presentation at Cantech 2017

Page 1: 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

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• 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

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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

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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

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• 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

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• 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

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Contact:Alison SilvaPresident & CEOOffice: (519) 858-5157Mobile: (860) [email protected]

www.criticaloutcome.comwww.criticaloutcomeblog.comwww.facebook.com/criticaloutcometwitter.com/criticaloutcomewww.slideshare.net/criticaloutcome