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COTI Corporate Presentation at Cantech 2017


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Corporate presentation delivered by President and CEO, Alison Silva at the 2017 Cantech Investment Conference in Toronto on January 18th.

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COTI Corporate Presentation at Cantech 2017

  1. 1. Advancing the Treatment of Cancer Through Targeted Therapeutics January 2017
  2. 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. 3 • 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
  4. 4. • 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 4 COTI-2 Mechanism of Action & Synopsis mutp53 mutp53 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. 5. 5 0 50 100 150 200 0 5 9 16 23 30 37 44 51 61 TumorVolume(mm3) 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 TumorVolume(mm3) 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 * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * 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
  6. 6. 6 • 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 * * * * * * * * * * * * * Jeffrey Myers, U of Texas, MDACC, Houston, TX. Significant Tumor Growth Inhibition in Combination with Cisplatin
  7. 7. 7 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
  8. 8. • 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 8 Anticipated COTI2-101 Clinical Trial News Flow
  9. 9. • 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 9 COTI-2 Best-in-Class Potential
  10. 10. 10 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-Fraumeni syndrome  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 balancesheet to execute on corporate strategies • Establish collaborations/partnershipsfor COTI-2, pipelineprograms 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
  11. 11. 11 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
  12. 12. 12 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
  13. 13. Contact: Alison Silva President & CEO Office: (519) 858-5157 Mobile: (860) 798-0816