Biomark Diagnostics, Inc. · CSE:BUX
Biomark Diagnostics — Investor Presentation (June 2019)
32 slides from Biomark Diagnostics's investor presentation, June 2019
Slide 1: BioMark Diagnostics Inc
BioMark DIAGNOSTICS INC A Next Generation Company Powered by Metabolomics www.biomarkdiagnostics.com
Slide 2: Our Mission / Who We Are
BioMark DIAGNOSTICS INC Our Mission To provide access to a new paradigm in cancer diagnostics using metabolomics Who We Are • Oncology-focused company with advanced near-to-market diagnostic technologies • Multiple IPs generated in detection and quantitation of metabolites - collectively over 20 pat
Slide 3: About BioMark: Executive Team
ABOUT BIOMARK Executive Team • Rashid Ahmed, MBA – Founder, Chief Executive Officer • Dr. Thomas Malcolm, Ph.D – Chief Scientific Advisor • Dr. Bram Ramjiawan, Ph.D – Clinical Trial and Regulatory Expertise • Brian Cheng, MSc– Chief Technical Officer • Dr. Kenneth Kohn, Ph.D – Patent Attorney • Gina
Slide 4: About BioMark: Research/Scientific/Clinical Team
ABOUT BIOMARK • Research/Scientific/Clinical Team Dr. Daniel Sitar – Principal Scientific Advisor / Professor Emeritus, University of Manitoba Dr. David Wishart - Professor, Depts. of Computer Science and Biological Sciences, University of Alberta Dr. Myron L. Weisfeldt - M.D., University Distinguis
Slide 5: Terms – Metabolomics – Coordinates for your cellular GPS
Terms – Metabolomics – Coordinates for your cellular GPS. An Emerging and disruptive technology •Metabolites are products or by products of the chemical interactions in every cells. Cancer cells create an abnormality in the metabolism of the cells that can cause a tumour to grow out of control. •Met
Slide 6: Metabolomics is Moving to the Bedside
Metabolomics is Moving to the Bedside • Number of “approved” tests arising from Metabolomics/Clinical Chem. – 334 • Number of “approved” tests arising from or using Genomics – 130 • Number of “approved” single Protein tests (ELISA) – 108 • Number of “approved” tests arising from or using Transcripto
Slide 7: Value Proposition – Physician, Patient, Payer and Pharma Impact
Value Proposition – Physician, Patient, Payer and Pharma Impact • Provide better early detection technologies that are reliable, non invasive and cost effective to reduce later costs of treatment – drug and hospitalization costs • Provide better tools to assess treatment efficacy earlier so as to ta
Slide 8: Clinical Application in Lung Cancer
Clinical Application in Lung Cancer
Slide 9: Discovery and Development of Metabolomic Assays
Discovery and Development of Metabolomic Assays Completed development and validation of 2 principle assays – Platform Play a). Acetyl Amantadine SSAT1 Assay • Based on key discovery by Dr. Sitar UoM – Amantadine and SSAT1 (Linked to Polyamine pathway) • Recently completed a clinical trail based on a
Slide 10: Assay I: Acetyl Amantadine SSAT1 Assay
Assay I Acetyl Amantadine SSAT1 Assay
Slide 11: SSAT1 Biochemistry – Polyamine Pathway – Well Researched
SSAT1* Biochemistry – Polyamine Pathway – Well Researched *Spermine Spermidine Acetyl Transferase Source: American Journal of Physiology - Endocrinology and Metabolism Published 4 June 2008 Vol. 294 no. 6
Slide 12: How We Conduct Our Test (SSAT1 Assay)
How We Conduct Our Test (SSAT1 Assay) - Convenient & Non Invasive Amantadine + Water 2 – 4 hrs Point of Care Labs Physician Facility OR Home Collect Biological Sample (Urine or Blood) IVD Analyze or Confirm POC
Slide 13: Activities Undertaken in Discovery and Development Phase of SSAT1 Assay
Activities undertaken in Discovery and Development Phase of SSAT1 Assay Validation of SSAT1 platform / Expansion to other metabolites • Confirmation at genomic level using PCR and cell line studies at BRI (2011-003) • Proteomic level (Western Blot WB*) – cancer tissue samples from Manitoba Tumour Ba
Slide 14: BioMark SSAT1 Assay - Measurement Technologies
BioMark SSAT1 Assay - Measurement Technologies Liquid Chromatography Mass Spectrometry(LC/MS) – Gold Standard •Highly sensitive detection from urine and blood •Secured Investigational and Testing Authorization from Health Canada 2014 Modified Mass Spectrometry (DART) – Positioned to reduce quantific
Slide 15: Current SSAT1 Assay Activities
Current SSAT1 Assay Activities • Phase III Clinical Trial – Urinary Excretion of Acetylamantadine by Cancer Patients - Health Canada & Ethics Approval, in Canada & Bangladesh; - Completed clinical trial follow-up on outliers and preparing submission to Health Canada • Clinical Trial – Response to Ch
Slide 16: Assay II: Targeted BioMarker Panel for Lung Cancer Using Serum
Assay II Targeted BioMarker Panel for Lung Cancer Using Serum
Slide 17: Recently Completed Initiative – Discovery and Validation
Recently Completed Initiative – Discovery and Validation Goal: Discover and validate putative lung cancer on N. American cohort markers that : • Distinguish normal vs lung cancer groups with emphasis on early stage 1 and 2 lung cancer. • Separate the sub-types (adeno and squamous) • Incorporate othe
Slide 18: Targeted Metabolomics Lung Cancer Study
Targeted Metabolomics Lung Cancer Study Data Summary ➢ Metabolomics Analysis: Human serum samples* were analyzed using custom developed assay for several putative lung cancer biomarkers ➢ Total subject: 257 • Normal: 60 • Lung Cancer: 197 (emphasis on stage1 and 2) * Samples and data obtained from I
Slide 19: Sample results – AUROC: Stage 1 vs Normal
Sample results – AUROC*: Stage 1 vs Normal 6 Metabolites included to the model *AUROC = Area Under Receiver Operating Curve AUC - ROC curve is a performance measurement for classification problem at various thresholds settings. Higher the AUC, better the model is at distinguishing between patients w
Slide 20: AUROC: Stage 1 vs Normal with Smoking
AUROC: Stage 1 vs Normal with Smoking Stage 1 Vs Normal Model + Smoking (Period of smoking + Quantity of Smoking) 6 Metabolites included to the model
Slide 21: AUROC: Stage 2 vs Normal
AUROC: Stage 2 vs Normal 5 Metabolites included to the model
Slide 22: AUROC: Stage 2 vs Normal With Smoking
AUROC: Stage 2 vs Normal With Smoking 5 Metabolites included to the model
Slide 23: AUROC: Squamous (Stages 1 and 2) vs. Normal
AUROC: Squamous (Stages1 and 2) vs. Normal 5 Metabolites included in the model
Slide 24: Next Steps for Lung Cancer Panel
Next Steps for Lung Cancer Panel In progress -larger cohort studies based on power calculation (1200-1500) - Various stages - Sub-types - Healthy and negative controls
Slide 25: Multiple Clinical Applications of Lung Cancer Panel
Multiple Clinical Applications of Lung Cancer Panel • Target the high-risk smokers on the Low Dose CT screening program in the US – Smokers over 55 in age with defined smoking parameters. Using 3 to 4 key metabolites plus other clinical variables can yield robust assay that can replace or complement
Slide 26: Lung Cancer Screening Program in US
Lung Cancer Screening Program in US
Slide 27: Commercialization Roadmap - Market Focus: Lung Cancer
Commercialization Roadmap -Market Focus: Lung Cancer Lung Cancer High Risk Screening Program in USA - Lung Cancer Screening in US for high risk groups to complement Helical CT Scan - Estimated High Risk Population : 8 million - Only 3.4% of the high risk population are screened using Helical CT; 18%
Slide 28: Market Focus – Response To Treatment For Lung Cancer
Market Focus – Response To Treatment For Lung Cancer Use BioMark’s assay to predict response and outcome of systemic therapy for patients on chemotherapy and radiotherapy treatment Outcome: -Modify / Personalize treatment for patients earlier -Reduce costs associated with expensive therapies with an
Slide 29: Potential Revenue Streams
Potential Revenue Streams • Sales of products / supplies • Royalty on lab analysis (per test) • Licensing – Territorial and distribution licensing • Services - Monitoring - Companion Diagnostics* (CDx) for drug companies *A companion diagnostic (CDx) is a diagnostic test used as a companion to a the
Slide 30: Technology Development Pipeline
Technology Development Pipeline Planning Development Validation Health Canada Approval Market Internal Standards developed and data points SSAT-Amantadine Assay using LC/MS collected and to be validated. Transferable to FDA SSAT-Amantadine Assay using ELISA Kit Collaboration with an IVD kit manufact
Slide 31: Traction
Traction Regulatory - Secured Clinical Trial Acceptance and Investigational Testing Authorization (ITA) from Health Canada Innovation and Pipeline Expansion - Developed and validated specific fingerprints for lung and breast cancers with TMIC (The Metabolomics Innovation Centre) Integrating Analytic
Slide 32: Contact Details
Contact Details Name: Rashid Ahmed Bux Email: [email protected] or [email protected] Phone – office: 604 370 0779 WWW.BIOMARKDIAGNOSTICS.COM
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