29 slides from Insight Molecular Diagnostics's investor presentation, Sep 8, 2016
Slide 1: Liquid Biopsies: Next Generation Cancer Molecular Diagnostics
Liquid Biopsies Next Generation Cancer Molecular Diagnostics William AnnettChief Executive OfficerSeptember 2016
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 Positioned to capitalize on standard of care moving to liquid biopsyAddresses large unmet needs for early, accurate diagnosis in multiple cancersInitial focus on lung, one of the largest markets and a national health priorityCurrent lung cancer standard of care is inaccurate, r
Slide 4: Molecular diagnostics are evolving toward non-invasive liquid biopsies
Molecular diagnostics are evolving towardnon-invasive liquid biopsies IMAGING TISSUE BIOPSY LIQUIDBIOPSY MammogramLDCT VeracyteGenomic Health 4
Slide 5: Some molecular diagnostics companies have substantial valuations
Some molecular diagnostics companies have substantial valuations Source: Bloomberg as of 5/18/2016 In some cases based on incremental improvements and/or small markets 5 OncoCyte is focused on the largest segment and the biggest market opportunity Market Capitalization $100M $200M $300M $400M $500M
Slide 6: OncoCyte is focused on early diagnosis, the largest market segment
Source of revenue: The 2015 Liquid Biopsy Report Piper Jaffrey September 2015 Recurrence $6.9B Companion Diagnostics $6.7B Diagnosis $15B Prognostic OncoCyte is focused on early diagnosis – the largest market segment, but with low competition 6 Prognosis Diagnosis $15B Companion Diagnostics$6.7B Rec
Slide 7: Lung cancer is the largest market opportunity
Lung cancer is the largest market opportunity Largest % of global diagnostics revenue Most cancer deaths each year in the U.S. Cancer Diagnostics Market: Global Industry Analysis, Size, Share, and Forecast 2014-2020, Transparency Market ResearchDiagnostics include both imaging and molecular diagnost
Slide 8: Lung cancer is typically diagnosed at later stages, limiting survival rates
Lung cancer is typically diagnosed at later stages, limiting survival rates57% of lung cancer diagnoses are made in stage IV Sources: Cancer SEER Stat Fact SheetsNCCN Guidelines Lung Cancer Screening 2/2014USPSTF Screening for Lung Cancer 8 Colorectal Breast Lung Prostate FDA approval for prostate p
Slide 9: Lung cancer diagnosis is the highest unmet need
Lung cancer diagnosis is the highest unmet need 9 The most lethal cancer with one of the worst survival rates, but one of the poorest standards of care Bubbles represent number of U.S. deaths per year Probability of false positive test under current standard of care(leading to unnecessary and expens
Slide 10: Early detection of lung cancer is now a national health priority
Early detection of lung cancer is now a national health priority because it has the highest death rate Better diagnosis will increase the survival rate and save livesDecember 2013 USPSTF guidelines recommend annual LDCTs for patients with 30 pack-year history7-10M AmericansFebruary 2015CMS announces
Slide 11: Current standard of care is risky and expensive
Current standard of care is risky and expensive Follow up procedures are also expensiveBiopsies via bronchoscopies, surgery, needle biopsyFrequent follow up LDCTs (radiation exposure)Lung biopsies are much riskier than other types of biopsies, and deaths could be avoided:0.5 to 1% mortality (600 to
Slide 12: Pipeline diagnostics based on platform with commercial advantages
12 Pipeline diagnostics based on platform with commercial advantages Diagnostic Strategy *... potentially malignant, clinician to determine follow up procedure.
Slide 13: OncoCyte's initial focus is on confirmatory diagnostic solution
13 High-risk patients LDCT screening Clear Biopsy Malignant Benign nodule Follow-upLDCT scans Nodules Confirmatory USPSTF Guidelines Recommend Screening – Covered by Medicare OncoCyte’s initial focus is on confirmatory diagnostic solution No nodules 7-10M Americans 96% False Positive
Slide 14: OncoCyte's preliminary test shows strong performance
Prototype classifier presented at American Thoracic Society in 2015Sensitivity: 76%Specificity: 88%Proof of concept for confirmatory diagnostic and screening diagnostic 14 Bioinformatics lab of Dr. Louise C. Showe9+ years developing blood-based tests for lung cancerSignificant sample set (3,000 samp
Slide 15: Large market opportunity for lung tests
TAM numbers based on company estimates and secondary data 15 Large market opportunity for lung tests USPSTF guidelines for 30 pack-year smokers All indeterminate diagnoses (LDCT +) Downstream procedures performed on indeterminate diagnoses Confirmatory test extended use(1.8-2.5 million patients) Ove
Slide 16: High clinical utility: fewer risky procedures and significant cost savings
High clinical utility – the potential for fewer risky procedures and significant cost savings Current Standard of Care OncoCyte’s Test as part of Standard of Care OncoCyte’s test could result in $1.4B to $4.0B in annual U.S. cost savings 140,000 to 380,000 fewer procedures annually9,000 to 26,000 fe
Slide 17: Compelling proposition for payers
Compelling proposition for payers Payers gave diagnostic high ratings for unmet needs Pricing and TPP discussion with payers very positive Asked of 10 Commercial, Managed Medicaid and Managed Medicare payers representing 20M covered livesQ8: Now I would like to ask what is your perception of the ove
Slide 18: Compelling proposition for prescribers
Compelling proposition for prescribers Interest in using the OncoCyte test is very high with a mean rating of 8.5 out of 10Pulmonologists expressed highest interest at 9.3, followed by interventional radiologists at 8.7Reasons provided for high ratings: Useful for smaller nodules with high risk fact
Slide 19: Commercialization strategy addresses all key stakeholders
Commercialization strategy addresses allkey stakeholders ProviderDeterminate diagnosisHigh sensitivity High specificityReduce unnecessary procedures PatientEarlier detectionImproved outcomesReduce anxiety over indeterminate finding PayerImproved health outcomesFewer unnecessary proceduresReduce over
Slide 20: OncoCyte's deep product pipeline
Research Assay Development R&D Validation Study CLIA Validation Clinical Utility Studies Breast screening Lung confirmatory May materialize as confirmatory, screening, recurrence or companion diagnostic* Dependent on partnering discussions OncoCyte launch focus Partner focus 20 OncoCyte’s deep produ
Slide 21: Breast cancer confirmatory diagnostic under development
21 Screening Population ScreeningMammogram Clear Suspicious DiagnosticMammogram Clear Suspicious Biopsy BIRADS 3/4 BIRADS 1/2 CONFIRMATORY SCREENING Breast cancer confirmatory diagnostic under development
Slide 22: Breast cancer diagnostic overview
Breast cancer diagnostic overview High false-positive rate of mammography and ultrasound leads to unnecessary biopsies and increased costsTarget population: women with dense breast tissue, genetic mutations (BRCA), a family history of breast cancer, or those who have suspicious diagnostic mammogram
Slide 23: Large market opportunity for breast cancer diagnostic tests
TAM numbers based on company estimates and secondary data 23 Large market opportunity for iterative breast cancer diagnostic tests Guidelines suggest annual mammogram screen Guidelines suggest MRI (dense tissue, BRCA, family history) Indeterminate mammograms Confirmatory test extended use (6 million
Slide 24: Bladder prototype data presented at AACR 2015
ROC AUC = 0.91Sensitivity = 90%Specificity = 83% 24 Bladder prototype data presented at AACR 2015 Potential to partner development and/or commercialization of bladder cancer test
Slide 25: Classifier performance is strong in areas of greatest health outcome impact
25 Classifier performance is strong in areas of greatest health outcome impact High grade bladder cancer is faster growing and more likely to spread than low gradeHigh sensitivity/specificity in high grade hematuria and high grade recurrenceStudy based on 261 patients Data from follow on study prese
Slide 26: Large market opportunity for bladder cancer diagnostic tests
TAM numbers based on company estimates and secondary data 26 Large market opportunity for bladder cancer diagnostic tests Hematuria Cancer in remission Indeterminate cytology results Recurrence test (500,000 patients x2) Screening test(3 million patients) Confirmatory test (500,000 patients) Current
Slide 27: Management team with commercial experience
Management team with commercial experience William Annett CEO CEO BioFx Labs; CEO Corra Life Sciences; Managing Director Accenture Life Science; Led Commercial Strategy, Project Finance Genentech; Harvard MBAKaren Chapman VP Research Advanced Cell Technology; Origen Therapeutics; Geron Corporation;
Slide 28: Investment Highlights
Investment Highlights Positioned to capitalize on standard of care moving to liquid biopsyAddresses large unmet needs for early, accurate diagnosis in multiple cancersInitial focus on lung, one of the largest markets and a national health priorityCurrent lung cancer standard of care is inaccurate, r
Slide 29: William Annett, Chief Executive Officer
William AnnettChief Executive OfficerWAnnett@OncoCyte.com Liquid Biopsies Next Generation Cancer Molecular Diagnostics