Slide 1: Liquid Biopsies: Advancing cancer diagnosis
Liquid Biopsies Advancing cancer diagnosis William Annett Chief Executive Officer June 2017
Slide 2: Forward Looking Statements
Forward Looking Statements Statements pertaining to future financial and/or operating results, future research, diagnostic tests and technology under development, clinical development of diagnostic tests, and potential opportunities for OncoCyte Corporation and the diagnostic tests it is developing,
Slide 3: Investment Highlights
Investment Highlights • Focused on largest unmet needs for early, accurate cancer diagnosis • Compelling value proposition for physicians, patients, and payers • Lung confirmatory test launch planned second-half 2017 • Breast confirmatory test being developed as second product • Experienced leadersh
Slide 4: Oncocyte is focused on early diagnosis – the largest market segment with less competition
Oncocyte is focused on early diagnosis – the largest market segment with less competition Companion Diagnosis Recurrence Prognosis Diagnostics $15B $6.9B $6.7B 4 Source of revenue: The 2015 Liquid Biopsy Report Piper Jaffrey (September 2015).
Slide 5: OncoCyte is focused on areas of greatest unmet need and most attractive margins
OncoCyte is focused on areas of greatest unmet need and most attractive margins 130% C Product Contribution Opportunity ($Bs) 110% 90% Lung Confirmatory (5-year death rate) Health Outcomes 70% $3.9 Colorectal $3.2 Ovarian 50% $.2 Breast 30% Confirmatory $5.4 Bubbles represent product 10% contributio
Slide 6: Diagnostics based on gene expression classifier and binary call
Diagnostics based on gene expression classifier and binary call 6
Slide 7: OncoCyte’s deep product pipeline
OncoCyte’s deep product pipeline
Slide 8: Lung opportunity driven by poor outcomes with little improvement over the last 40-years
Lung opportunity driven by poor outcomes with little improvement over the last 40-years Lung cancer is typically diagnosed at later stages, with 57% of diagnoses made in stage IV, limiting survival rates FDA Approval for prostate screening test FDA Approval for prostate Prostate progression test Bre
Slide 9: Post-LDCT biopsies are risky and expensive
Post-LDCT biopsies are risky and expensive • Lung biopsies – via needle, bronchoscopy or surgery – are much riskier than other biopsies Incidence Complication Annual (%) Events (~#) 0.5–1% Mortality 600–1,300 4–20% Major 5,000–26,000 complications (including collapsed lung) For an average patient, •
Slide 10: Large market opportunity for lung tests
Large market opportunity for lung tests Lung Imaging Overall Lung Nodule Market (10–15 Million Patients) Expanded Use All indeterminate diagnoses Lung-RADS 3 & 4 (≥5mm) (~1.4 Million Patients) Downstream procedures Initial Use performed on Lung-RADS 4 (≥8mm) indeterminate (~400,000–600,000 Patients)
Slide 11: Oncocyte’s initial focus is on a confirmatory diagnostic solution
Oncocyte’s initial focus is on a confirmatory diagnostic solution Confirmatory 7–10M Americans High-risk, 30 Pack-year history USPSTF Guidelines recommended Malignant screening – covered by Medicare Biopsy Suspicious Benign nodules nodule ow-up LDCT No suspicious LDCT scans screening nodules Clear 5
Slide 12: OncoCyte’s preliminary test shows strong performance
OncoCyte’s preliminary test shows strong performance • Prototype classifier presented at the American Thoracic Society (ATS) 2015 International Conference – Sensitivity 76% – Specificity 88% • Bioinformatics lab of Dr. Louise C. Showe • 9+ years developing blood-based tests for lung cancer • Signifi
Slide 13: Wistar validation suggests commercially attractive diagnostic
Wistar validation suggests commercially attractive diagnostic • Validated results from a large (n=610) sample analysis, biomarkers only presented at the CHEST 2016 Annual Meeting • Validated results show comparable findings to previous study – Sensitivity 90% – Specificity 62% 100 Gene Model 13
Slide 14: OncoCyte validation study confirmed Wistar results
OncoCyte validation study confirmed Wistar results Findings suggest assay could significantly improve standard of care • Validated results from a large (n=299) sample analysis of prospectively collected samples presented at ATS AUC = 0.92 2017 • Validated results show comparable findings to previous
Slide 15: High clinical utility – the potential for fewer risky procedures and significant cost offsets
High clinical utility – the potential for fewer risky procedures and significant cost offsets OncoCyte’s test could result in $2.2B to $4.7B in annual US cost offsets Current Standard of Care OncoCyte’s Test as part of Standard of Care USPSTF Guidelines and USPSTF Guidelines and Incidentally Detecte
Slide 16: Lung is a compelling proposition for payers
Lung is a compelling proposition for payers High ratings for unmet needs and positive pricing and TPP feedback “High need driven by lack of good “Not just about the expense, there is also screening procedures and a clinical increase morbidity and mortality with concern to identify patients earlier”
Slide 17: Physicians in target specialties express highest level of interest
Physicians in target specialties express highest level of interest OncoCyte’s test is a compelling value proposition for physicians Interest in Using OncoCyte Product 10 9.3 8.5 8.3 8.7 9 7.8 8 7 6 5 4 3 2 1 Total Oncologists Radiologists Interventional Pulmonologists radiologists • Reasons provided
Slide 18: Commercialization strategy addresses key stakeholders
Commercialization strategy addresses key stakeholders Physicians Patients Payers • Determinate diagnosis • Earlier detection • Improved health • High sensitivity, • Improved outcomes outcomes specificity • Reduce anxiety over • Fewer unnecessary Benefits • Reduce unnecessary indeterminate finding pr
Slide 19: Sales strategy focused on targeted physician specialties
Sales strategy focused on targeted physician specialties Small specialty sales force ramps-up in 2H 2017, additional hires as coverage is gained Primary Specialty Sales Force Secondary Pulmonologists Radiologists Interventional Interventional Pulmonologists Radiologists Thoracic Surgeons 19
Slide 20: Physician marketing focused on medical conferences and speakers bureau
Physician marketing focused on medical conferences and speakers bureau CHEST Annual (International) Conference October 28–November 1, 2017 in Toronto, ON, Canada • Formal presence focused on market development including exhibit booth, educational seminars OncoCyte Speaker’s Bureau 2H2017 and 2018 •
Slide 21: Patient marketing focused on increasing screening awareness and compliance
Patient marketing focused on increasing screening awareness and compliance Patient Assistance Program • To offset out-of-pocket expenses related to test Screening Awareness and Education • Syndicated, educational video airing during Lung Cancer Awareness Month (November) • Collaboration with advocac
Slide 22: Reimbursement strategy has three key components
Reimbursement strategy has three key components • MAAA Ensured status allows value based pricing • Pursue ADLT status Coding • Launch with unlisted code • Obtain unique CPT code when CMS coverage is gained • MolDx has clear pathway to coverage • Develop and implement a strong evidence and publicatio
Slide 23: Successful trials should result in reimbursement
Successful trials should result in reimbursement • Strong clinical validation and utility MolDx Coverage Pathway studies key to coverage MolDx Clinical Trial Clinical Trial Level of Design Principal Design Evidence Study Secondary • OncoCyte’s strategy is to provide Study the highest level (IA) of e
Slide 24: Focused reimbursement strategy supports value-based pricing
Focused reimbursement strategy supports value-based pricing MAAA Creates PAMA Optimize Maintains value-based contracting price value-based strategy pricing • OncoCyte test is MAAA • Private payer contracting • Medicare price based on strategy maintains weighted commercial median • Full list price fo
Slide 25: One of largest US Market opportunities
One of largest US Market opportunities $2.1B $4.7B Initial Use Expanded Use 400,000–600,000 Patients 1.4 Million Patients Company estimates based on LungRADS guidelines and NLST data, list price comparable to existing molecular diagnostics with algorithm 25 Percepta list price $4,875, Affirma CMS re
Slide 26: Current standard of care is not meeting the needs of many women
Current standard of care is not meeting the needs of many women • High-number of unnecessary biopsies – ~1.7M Biopsies performed annually – ~$2.8B Annual cost associated with false-positive mammograms • Mammograms perform poorly for one out of every six women resulting in follow-up MRIs – Dense brea
Slide 27: Focused on eliminating unnecessary biopsies and MRIs
Focused on eliminating unnecessary biopsies and MRIs Intended Use Profile 1: CONFIRMATORY MRI Intended Use Profile 2: ADJUNCT for high-risk patients 27
Slide 28: Large market opportunity for breast cancer diagnostic tests for specific patient profiles
Large market opportunity for breast cancer diagnostic tests for specific patient profiles Guidelines suggest annual mammogram screening Overall screening market (39 Million Patients in 2016) Guidelines suggest MRI (dense tissue, BRCA, family history) Supplemental screening test (6 Million Patients)
Slide 29: Compelling proof of concept presented at 2016 San Antonio Breast Cancer Symposium
Compelling proof of concept presented at 2016 San Antonio Breast Cancer Symposium Serum Biomarker Assay Research Serum SomaScan Biomarker Samples 1.3K Identification Patients undergoing biopsy Screen 1,310 protein analytes Analysis and algorithm in multiplexed format development 15-Marker Model: AUC
Slide 30: Management team with commercial experience
Management team with commercial experience Position Experience William Annett President & CEO CEO BioFx Labs; CEO Corra Life Sciences; Managing Director Accenture Life Science; Led Commercial Strategy, Project Finance Genentech; Harvard MBA Lyssa Friedman VP Clinical and Veracyte VP Clinical Operati
Slide 31: Investment Highlights
Investment Highlights • Focused on largest unmet needs for early, accurate cancer diagnosis • Compelling value proposition for physicians, patients, and payers • Lung confirmatory test launch planned second-half 2017 • Breast confirmatory test being developed as second product • Experienced leadersh
Slide 32: Liquid Biopsies
Liquid Biopsies Advancing cancer diagnosis William Annett Chief Executive Officer wannett@oncocyte.com www.oncocyte.com NYSE MKT: OCX