Advancing Cancer Diagnosis Improving patient outcomes while lowering health care costs February 2019 NYSE AMERICAN: OCX
Forward looking statements This presentation is confidential and the information herein may not be copied, modified, reproduced, redistributed, divulged or passed on, directly or indirectly, and you may use (including to trade on the basis of) any information herein. This presentation is for informational purposes only. This document does not constitute an offer or solicitation to sell securities in any jurisdiction. It does not purport to contain all of the information that may be relevant to you. Certain information contained in this presentation may be derived from information provided by industry sources. OncoCyte believes such information is accurate and that the sources from which it has been obtained are reliable. However, OncoCyte cannot guarantee the accuracy of, and has not independently verified, such information. This presentation contains forward- looking statements that are based on OncoCyte’s current understanding, expectations, and assumptions, which OncoCyte believes to be reasonable. These statements involve inherent risks and uncertainties, including those relating to the development and/or commercialization of potential diagnostic tests or products, the results of clinical trials or regulatory approvals, the capacity of third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests commercialized. Actual results may differ materially from the results anticipated in these forward-looking statements. Please refer to the “Risk Factors” and other cautionary statements in OncoCyte’s Securities and Exchange Commission filings. OncoCyte disclaims any intent or obligation to update these forward-looking statements, except as required by law. Except as otherwise indicated, this presentation speaks as of the date hereof. 2
Investment Highlights • Oncology diagnostics company initially targeting lung cancer – highest mortality rate • DetermaVu™ blood test demonstrates best -in-class performance o $2B-$5B Total Addressable Market with high margin potential o Rapid pathway to commercialization (2H 2019) • Potential for Immune System Interrogation approach to address multiple types of cancer 3
DetermaVu TM Significantly Improves Standard of Care Current Standard The Future with DetermaVu TM of Care • • Major diagnostic dilemma Solves diagnostic dilemma • for physicians Greatly reduces • High number of unnecessary biopsies • unnecessary biopsies Reduces cost and • 24% serious complications complications • High cost 4
Advancing the Standard of Cancer Diagnosis IP Protected gene expression classifier with binary call Negative Positive 5
Lung is One of Largest US Market Opportunities $4.7B $2.1B Initial use Expanded use 400,000 – 600,000 Patients with 1.4 Million Patients with large nodules medium to large nodules Company estimates based on LungRADS guidelines and NLST data, list price comparable to existing molecular diagnostics with algorithm 6 Percepta list price $4,875, Affirma CMS reimbursement $3,100.
Detecting Lung Cancer Early is Critical Lung cancer is typically diagnosed in Stage IV, resulting in grim 5-year survival Prostate 100% Breast 90% 80% Bladder 70% Colorectal 60% Five-year Survival Rate 50% 40% 30% 20% Lung 10% 0% 1975 1980 1985 1990 1995 1999 2003 2007 But detection in Stage I gives 5-year survival comparable to other major cancers 7
Well-funded PSA Campaign Seeks to Boost Screening Rates in High-Risk Population 8
Lung Cancer Detection Process 10 – 15M smokers should get annual Low Dose CT scans Home If medium/large nodules are found, biopsy carried out ICU 9
Lung Biopsies are Risky and Expensive • Lung biopsies are much riskier than other cancer biopsies o Up to 1% result in death o Up to 24% result in serious complications • Mean U.S. cost is $14,634 per biopsy • For an average patient, a lung biopsy has a higher likelihood of leading to a serious complication than of confirming lung cancer, impacting interest in screening DetermaVu TM is designed to directly address this challenge by reducing unnecessary biopsies 10
Successful R&D Validation Study ROC Curve • Demonstrates best-in-class performance • Blinded results from 250 sample prospective cohort demonstrate excellent performance o Sensitivity: ~90% (95%CI 82%-95%) o Specificity: ~75% (95%CI 68%-81%) • Exceeds physician requirements of >85% sensitivity and >35% specificity • Significantly outperforms reported results from clinical models and all competitors’ tests • No clinical data utilized; results from biomarkers alone Proof-of-concept of Immune System Interrogation approach opens the door for high-value strategic opportunities 11
Capital-Efficient Commercialization Plan • Capital on hand is sufficient to reach commercialization • Efficient and focused sales and marketing plan o ~6,000 pulmonologists can be covered with a small specialty sales force • Targeting both high gross margin and high net margin • Plan to initiate commercialization activities in 2H2019 12
Commercialization strategy addresses all key stakeholders • • Determinate diagnosis Earlier detection • Improved health • • High sensitivity, Improved outcomes outcomes • specificity Reduce anxiety over • Fewer unnecessary Benefits • Reduce unnecessary indeterminate finding procedures biopsies • Reduce overall costs ✓ Aim for highest level ✓ ✓ Medical conferences Increase awareness of evidence in exhibits and symposia to increase LDCT Marketing clinical trials ✓ Specialty sales force uptake ✓ Contracting strategy Strategy ✓ ✓ Speakers bureau Patient friendly test aligned to value ✓ Peer reviewed report added pricing ✓ publications Patient assistance ✓ RWE Clinical utility ✓ Practice Guidelines program studies CMS 1 st Coverage ✓ focus • • Begin upon Begin at Timing • Begin at commercial successful completion commencement of availability of Clinical Validation clinical utility study 13
Payers View DetermaVu™ Very Favorably • Previewed intended use and clinical development plan with medical directors from 10 public and commercial payers o 77M Covered lives o Positively received • All recognized the large unmet medical need DetermaVu TM addresses • Expressed strong support for DetermaVu’s clinical development plan Indicated high level of interest in reimbursing DetermaVu TM if studies • successful 14
Broader Implications of Immune System Surveillance Approach • OncoCyte is first ever to demonstrate the ability to utilize immune response to diagnose early-stage cancer • Proof of concept for potential product offerings across multiple cancer types • Immune System Interrogation approach approach leverages the exquisite sensitivity and response of immune system to detect early stage cancers 15
What Sets OncoCyte Apart? OncoCyte’s Approach Grail, Guardant, Freenome, Exact, Veracyte… Immune Direct System Measurement Interrogation Meth- Cancer Proprietary algorithm utilizing ctDNA DNA Cells selected biomarkers Leverages the exquisite Insufficient sensitivity in early- sensitivity of the immune stage cancers system’s response to early -stage Just not enough ‘signal’ to detect cancer Immune System Interrogation approach could have broad application: o Other cancers o Chronic diseases o Infectious diseases 16
Why does the OncoCyte Approach Work? OncoCyte leverages the exquisite sensitivity of the body’s immune system’s response to early- stage cancer Implicated in immune response to cancer mRNA – based OncoCyte technology - extracts may be from any of the cells present in whole blood for that patient - Differential gene expression takes place in response to the presence of cancer cells 17
Investment Highlights • Oncology diagnostics company initially targeting lung cancer – highest mortality rate • DetermaVu™ blood test demonstrates best -in-class performance o $2B-$5B Total Addressable Market with high margin potential o Rapid pathway to commercialization (2H 2019) • Potential for Immune System Interrogation approach to address multiple types of cancer 18
Advancing Cancer Diagnosis Improving patient outcomes while lowering health care costs Company Contact: Mitch Levine, Chief Financial Officer mlevine@oncocyte.com NYSE AMERICAN: OCX
Appendix NYSE AMERICAN: OCX
Lung Cancer: Highest Mortality Rate 234,030 New diagnoses 154,050 Deaths Annual Cancer Deaths Source: American Cancer Society, Cancer Facts & Figures, 2018 (all figures annual) 21
Cancer Diagnostic Continuum Diagnosis of Cancer Post-Diagnosis Diagnostics Recurrence Recurrence Genetic Pre- Screening for Targeted Diagnosis Risk Detection Disposition Therapies Predictor 22
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