The Wall Street Analyst Forum’s 17 th Annual Analyst Conference
Dec 19, 2015
The Wall Street Analyst Forum’s 17th Annual Analyst Conference
Forward Looking Statements…Forward Looking Statements…
During this presentation, our remarks will include forward-looking statements. These statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual results to differ materially from those anticipated or indicated. Any forward-looking statements should be considered in light of such risks and uncertainties including, without limitation, those detailed in the Company's filings with the SEC, including those discussed in the prospectus supplement.
Our Current MissionOur Current Mission
“To eradicate mortality from colorectal cancer through
early detection using applied genomics”
The Promise of EXASThe Promise of EXAS
• Large unmet medical market
• No controversy- early detection provides less costly treatment & saves lives
• Pre-Gen-Plus is first “average risk” marketed genomics diagnostic for CRC
• Molecular biology & mutations associated with CRC are well known
• Ability to detect these mutations in stool, which provides us with a biological advantage
• PreGen-Plus is the most accurate non-invasive diagnostic available
Five-year Survival Rate for CRCFive-year Survival Rate for CRC
Two-thirds of Patients are Diagnosed Too Late
Early DiagnosisEarly Diagnosis Late DiagnosisLate Diagnosis
0
25
50
75
100
0
25
50
75
100
Dukes A Dukes B Dukes C Dukes D
37% of Patients 63% of Patients
80%
55%
10%
95%
A Success and a FailureA Success and a Failure
Source: World Health Organization, American Cancer Society
1950 1960 1970 1980 1990 2000
FOBTColo Flex Sig
Screening Colo
Pap
ColorectalCervical
0
10,000
50,000
60,000
40,000
Colorectal vs. Cervical Cancer Death Estimates
The Opportunity in CRCThe Opportunity in CRC
0
20
40
60
80
100
2002 2003 2004 2005
20% Screened20% Screened
80% Unscreened80% Unscreened
People Over the Age of 50 Should Be Screened Regularly
Increases by 4 Million Each YearIncreases by 4 Million Each Year
People Over 50(Millions)
A New Genetic ModelA New Genetic Model
Validation of PreGen PlusValidation of PreGen Plus
• PreGen-Plus is a single test comprised of 23 molecular markers of CRC
• PreGen-Plus has significant clinical publications– Gastroenterology (2000,04, and 04)– Clinical Colorectal Cancer (2003)– New England Journal of Medicine (2004)– Journal of Molecular Diagnostics 2004
• Blue Shield California Technology Assessment
• Patients are more compliant– Single whole stool specimen – No bowel preparation – No medication or dietary restrictions – No sample manipulation
Clinical Utility = f (A x C x D)Clinical Utility = f (A x C x D)
Accuracy Compliance
Distribution / Access
FOBT
Flex Sig
Colonoscopy
PreGen-Plus™
Develop Cancer Specific Non-Invasive Assay
Demonstrate Superiority to Already Recommended Screening Modality in Average Risk Population (MCS)
Introduce Commercial Assay-PreGen-Plus™ through LabCorp
• Product Adoption/Guideline Inclusion/Payor Policy
Our Short Term Strategy
Observations & Confirmations
Observations & Confirmations
The Importance of Guideline InclusionThe Importance of Guideline Inclusion
Multi-Society Task Force/ACSMulti-Society Task Force/ACS
• 13 State Mandates
• NCQA/HEDIS Guidelines
• Requirement for self insured
• Positive impact on payors
• Will tip the scales for some doctors
How to get into GuidelinesHow to get into Guidelines
RequirementsRequirements
• Peer reviewed studies to prove equality/superiority
• Acceptability to patients
• Comparable or lower complication rates & costs
• Feasibility in general clinical practice
• Thought leader support
• Demand
GeneralGeneral
• 50% reduction in age-adjusted cancer mortality rates
• 25% reduction in age-adjusted cancer incidences rates
American Cancer Society2015 Challenge GoalsAmerican Cancer Society2015 Challenge Goals
Colorectal CancerColorectal Cancer
• Increase to 75% the proportion of people over the age of 50 years who have CRC screening consistent with ACS guidelines
– e.g., FOBT, flex sig, DCBE, colonoscopy
ReduceCancerReduceCancer
IncreaseScreeningIncrease
Screening
PayorsPayors
Managed Care / Self-Insured EmployersManaged Care / Self-Insured Employers
• Clinical Studies
• Thought Leaders
• Provider Pressure
• Membership Demand
• Cost Effectiveness
• NCQA/HEDIS Guidelines
EXAS Value Drivers EXAS Value Drivers
• Guideline Inclusion
• Payor Policy Decisions
• Strong Development Strategy– Improved Assay for CRC
– Assay for Pre-Cancer
Applied Research Applied Research
• Stage I√ Develop Cancer Specific Assay √ Demonstrate Superiority to Already Recommended Screening
Modality in Average Risk Population (MCS)√ Introduce Commercial Assay through partner– Guideline Inclusion
• Stage II – Increase Performance
• Cancer• Adenomas
– Decrease Cost
• Stage III– Apply Assay to Platform
• Kit Development
Development Strategy
Assay Improvements (Stage II)
• Increase DNA Yield– Effipure DNA Prep.
• Sample Handling– Stabilize Sample During Collection Method
• Marker Reformulation– De Novo Mutation Scanning (e.g. APC MCR)– Hypermethylation– Cancer Detection– Pre-Cancer Detection
Next GenerationAssay performanceTumor tissue analysis
Next GenerationAssay performanceTumor tissue analysis
Cancer tissues analyzed 94 94Assay positive samples 68 72.3% 88 93.6%
(95% CI) (62.2-81.1%) (86.6-97.6%)
Adenoma tissues analyzed 50 50Assay positive samples 31 62.0% 46 92.0%
(95% CI) (47.2-75.4%) (80.8-97.8%)
V1 assay V2 assay
The FutureThe Future
Other Screening Opportunities
More Depth in Colorectal Cancer
Expanding Internationally
The Wall Street Analyst Forum’s 17th Annual Analyst Conference