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2017 Annual General & Special Meeting of Shareholders

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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.

Published in: Investor Relations
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2017 Annual General & Special Meeting of Shareholders

  1. 1. Advancing the Treatment of Cancer Through Targeted Therapeutics Annual General and Special Meeting of Shareholders December 20, 2017
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

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