WHERE TOMORROW LIVES. Investor Presentation January 2020
Forward looking statements Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) are forward-looking statements. These statements include those pertaining to the time to complete and the results of Oncocyte’s ongoing CLIA Validation study of DetermaDx™, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our 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 we commercialize. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. 2
We are a molecular diagnostic company whose mission is to provide actionable answers to physicians and patients at critical decision points across the lung cancer care continuum, to optimize diagnosis and treatment, improve patient outcomes, and reduce overall cost of care. 3
Investment Highlights Proprietary molecular diagnostic tests address key decision points along the lung cancer treatment continuum to improve patient outcomes Initial focus on lung cancer content represents large market opportunity with significant unmet medical needs DetermaDx TM in development to revolutionize diagnosis, avoiding risky and costly biopsies/surgery DetermaRx TM improves patient survival, stratifies early stage lung cancer patients to identify those who may benefit from adjuvant chemotherapy Commercially ready with positive CMS reimbursement recommendation received DetermaIO TM is a potentially transformative immuno-diagnostic test for the selection of therapy for cancer patients. In recently published studies, DetermaIO out performed both PD-L1 and Tumor Mutational Burden Pioneering leadership team in molecular diagnostics from development to commercialization 4
Experienced Leadership Team Pioneering Molecular Diagnostics PADMA SUNDAR LYNDAL AL PARKER RONALD ANDREWS MITCH LEVINE Senior Vice President, HESTERBERG, PH.D. Chief Operating Officer President & Chief Chief Financial Officer Chief Scientific Officer Marketing/Market Access Executive Officer 5
Decision Points Along the Lung Cancer Care Continuum 6
Oncocyte: Strategically Addressing Lung Cancer Decisions 7
Initial Lung Cancer Focus Leverages Strategic Assets Lung “Pure Play” Advantages Opportunity Selection Criteria • Builds toward OCX as one-stop shop for lung cancer • Area of high unmet clinical need diagnostics • High degree of scientific confidence • Economy of scale – leverages OCX sales team, commercial infrastructure • Serve critical decisions points in clinical oncology • Development expertise in lung cancer biomarkers • Reimbursed or reimbursement ready content, or • Clinical trials recruitment expertise with over 60 current developing content with market predicate sites • High margin • Longitudinal patient data from diagnosis to treatment • LDT in U.S., potential to “kit” for ROW • Strong KOL representation and advocacy 8
Three Growth Vectors Partnership Mergers and Core Asset Opportunities Acquisitions Development Complete DetermaDx Validation Explore opportunities with external Complimentary High Value content and initiate prospective trial for technologies to offer complete for creating lung vertical claims expansion answers at critical decision points Leverage biobank for access to Initial sales in License Developed Content for methylation and cfDNA applications key territories OCX Channel Reimbursement High Value Content with current Pharma Services lab with High revenue streams and high gross Value content revenues margins 9
DetermaDx Opportunity Utilizing blood-based Interrogation methods to leverage the immune system’s response to cancer 10
Lung Cancer is the Leading Cause of Cancer Death Worldwide 11
Detecting Lung Cancer Early is Critical Lung cancer is typically diagnosed in Stage IV, resulting in grim 5-year survival rate Detection in Stage I gives 5-year survival comparable to other major cancers 12
Lung Cancer Diagnosis Over 1.6 million patients with lung nodules discovered annually in U.S via screening or incidentally 1 Home – No Complications Invasive biopsies or surgery of the nodules confirm a cancer diagnosis Hospitalization after complications 13 1. Gould, et al. (2015) Recent trends in the identification of incidental pulmonary nodules. American Journal of Respiratory and Critical Care Medicine 192:1206.
Lung Biopsies are Risky and Expensive 96% 3 of nodules found through 1 in 5 invasive diagnostic Mean U.S. cost of a biopsy is screening are benign, whereas procedures result in about ~$15,000 2 24%-26% 1 of biopsies result in complications 1 complications Mean cost of biopsy with serious complications is greater than $50,000 1 DetermaDx is designed to directly address this challenge by reducing unnecessary invasive diagnostic procedures 1. Huo, et al., JAMA Internal Medicine 179:324, 2019. 14 2. Lokhandwala, et.al., Clinical Lung Cancer, Jan;18(1):e27-e34, 2017. 3. National Lung Screening Trial Research Team. New England Journal of Medicine 365:395, 2011.
Oncocyte: Strategically Addressing Lung Cancer Decisions 15
Actionable Answers for a Critical Question in Cancer Diagnosis DetermaDx TM : Non-Invasive Gene expression classifier with binary call >500,000 High Risk Nodules* found annually ^ $1.75B ^ Market opportunity in US alone** ^ Actual wording of the test report to be sent to physicians has not been finalized * Number of 6-30mm nodules detected annually on CT Scans in patients with a smoking history (Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14. doi: 10.1164/rccm.201505- 0990OC., Journal of Clinical Oncology 36, No. 15_suppl (May 20, 2018) 6504-6504, and The Fleischner Society guidelines, https://pubs.rsna.org/doi/10.1148/radiol.2017161659. ** Uses an ASP of $3,500 based on reimbursement for similar tests. 16
How does the Oncocyte Approach Work? Oncocyte leverages the exquisite sensitivity of the body’s immune system’s response to early-stage 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
What Sets Oncocyte Apart? Other Companies Oncocyte’s Approach Immune System Interrogation Direct Measurement Proprietary algorithm utilizing ctDNA Meth-DNA Cancer Cells selected mRNA biomarkers Insufficient sensitivity in early-stage cancers Leverages the exquisite sensitivity of the immune system’s Just not enough ‘signal’ to detect response to early-stage cancer “Immune System Interrogation” approach could have broad application across other solid tumors 18
DetermaRx Proprietary Predictive Test for Early Stage Lung Cancer 19
Oncocyte: Strategically Addressing Lung Cancer Decisions 20
Early Stage Lung Cancer Can Be Deadly ~40,000 patients 1 are 30-50% of patients with Stage I & II NSCLC die with diagnosed with early- within 5 years despite having a complete resection 2 stage non-squamous NSCLC in the U.S. annually Identify patients that are likely to benefit from early, post-operative • chemotherapy Stratifying early-stage Reduce mortality and cost by preventing recurrences and expensive, • patients by recurrence late-stage treatment risk has the potential to: Avoid cytotoxic chemotherapy in patients who do not require treatment • beyond surgery 1. Meza, et al. (2015) Lung cancer incidence trends by gender, race and histology in the United States, 1973-2010. PLoS One 10:e0121323. 21 2. Woodard, et al. (2018) Adjuvant chemotherapy guided by molecular profiling and improved outcomes in early stage, non-small-cell lung cancer. Clinical Lung Cancer 19:58.
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