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• Privately held diagnostics company headquartered in Edmonton, Alberta, Canada
• Founded in May 2010 as a spin-off from University of Alberta
• Developed breakthrough product platform based on metabolomics
• Lead product is PolypDxTM, a non-invasive diagnostic urine test for adenomatous polyp detection – The Precursor to Colorectal Cancer.
2
MTI Company Overview
3
MTI Team
Jean ForsytheProject Coordinator
Lu Deng, PhDSenior Scientist
David Chang, PhDChief Executive Officer
Dr. Haili WangChief Scientific Officer
Dr. Richard FedorakPresident and Chief
Medical Officer
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PolypDxTM Opportunity
3rd most common cancer 2nd most frequent cause of cancer-
related deaths
>130,000 new cases of CRC every year 50,000 Deaths Annually
$14B spent annually treating colon cancer
Recommends that 89 million Americans be screened for colon cancer
1.3M new cases worldwide in 2012
Global rates rising due to lifestyle changes
International World Cancer Research Fund predicts 2.4M cases of CRC by 2035
4th most common cancer >300,000 new cases of CRC every year 360 million people ages 50-75 to be
screened
345,000 new cases in 2012
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CRC – Early Screening is Key
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Worldwide screening programs are currently in place to screen patients with colonoscopies.Currently many programs use a fecal based screening test to triage patients for colonoscopies.
Our product PolypDx™ to be used as a screening test triage the right patients for colonoscopies.PolypDx™ addresses two major issues:1) PolypDx™ is specifically designed for the detection of adenomatous polyps.2) Being a simple urine test, PolypDx™ will increase compliance of screening.
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Metabolomics Biomarker Discovery Platform
2 Clinical TrialsCanada: 1200 patientsChina: 1000 patients3 key peer reviewed publications
Wang H, Tso V, Wong C, Sadowski D, Fedorak RN. Clin Transl Gastroenterol. 2014;5:e54.Deng L, Chang D, Foshaug RR, Eisner R, Tso VK, Wishart DS, Fedorak RN. Metabolites 2017;7.Deng L, Fang H, Tso VK, Sun Y, Foshaug RR, Krahn SC, et al. Int J Colorectal Dis 2017;32:741-3.
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PolypDx™
Our product:
Annual check up forpatients ages 50-74
Urine samples collected and analyzed in a central laboratory
Patients with positive results are directed for polypectomy
Colorectal Cancer is prevented!
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PolypDxTM Competitive AnalysisFIT
Matrix Stool Blood Stool Urine
Primary Purpose
Cancer Detection Cancer Detection Cancer DetectionCancer PREVENTION
Sensitivity
92% - CRC42% - AdvancedPrecancerous Lesions17% - Non-advanced adenomas
68% - CRC
50-87% - CRC20-67% - advancedadenomas13-26% - adenomas
52.9% - Adenomas70.5% - CRC
Specificity 87% 80% 93-98% 80.0%
DetectingDNA mutations & methylation, hemoglobin, Beta actin
Methylated Septin9 DNA
Hemoglobin 3 Metabolites
Methodology DNA DNA/PCR ImmunochemicalMetabolomics & LC-MS/MS
Clinical Trial10,000 Patients; 65 w/CRC
7,941 Patients enrolled; Performance validated in 1,554; 44 w/CRC
various studies1000 Patients; 243 w/Adenoma122 w/CRC
Cost (USD) $599 $300 $20 $399
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MTI Development Milestones
Correlated analytes
Test algorithm developed Internal Validation
of Test algorithm
Closed Seed Round financing
Engaged AHS Labs to develop and optimize clinical protocol
Completed study with DynaLIFE Dx
Approval for logistics trial with AHS (Lethbridge, AB) supported by ACPLF through AIHS
Launch of PolypDxTM
with Atlantic Diagnostic Laboratories (ADL)
Clinical pilot with AHS Labs
Incorporation of Metabolomic
Technologies Inc.(May 6, 2010)
U.S. Provisional Patent Application filed
International Patent filed
Initiate HTP platform evaluation with DynaLIFE Dx
Agreement with BGI to conduct trials in China
Secured GoA-EAEfunding
Initiate clinical trial with BGI
HTP assessment through Custom Biologics
Secured NRC-IRAP Phase I
funding
Secured MDPD funding
External Validation of Test
algorithm
Trial attached to Edmonton Colon Cancer Screening Program (SCOPE)(2005-2012)
Submitted NRC-IRAP Phase II
2008 2009201720162015
20142013201220112010 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
3 Metabolites NMR test complete
Replicated 3 Metabolites NMR test in Mass Spec platform
Methods development and validation of MS test
Development of LDT in CLIA labs
Begin CPT code process
Ramp up of US sales force
US pilots at 3 university
cancer hospitals
Complete trial and testing in
China
LIS Development with SpiekerPoint to deploy algorithm
Development and verification of test on Waters FDA approved instruments
2nd
agreement signed
2018
Secure joint venture partner in China
Establish Medical Advisory Board
Multi-site CFDA trial in China
• Operational partner – License agreement with Atlantic Diagnositic Laboratories
• Sales and distribution – Atlantic Diagnostic Laboratories and AnyLabTestNow
• Reimbursement pathway – C.M.S. codemap process in progress
• Utilization pilots underway in USC, Sloan Kettering, Jefferson University
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US Business Development
• Seeking partner for JV to help with:
– Regulatory
– Manufacturing
– Sales and Marketing/Distribution
– Reimbursement
• In discussions with different potential partners
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China Business Development