WHERE TOMORROW LIVES. Investor Presentation January 2020 Forward - - PowerPoint PPT Presentation

WHERE TOMORROW LIVES.

Investor Presentation January 2020

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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

• btain 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.

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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

• verall cost of care.

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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 DetermaDxTM in development to revolutionize diagnosis, avoiding risky and costly biopsies/surgery DetermaRxTM 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 DetermaIOTM is a potentially transformative immuno-diagnostic test for the selection

• f 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

Experienced Leadership Team Pioneering Molecular Diagnostics

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RONALD ANDREWS President & Chief Executive Officer MITCH LEVINE Chief Financial Officer AL PARKER Chief Operating Officer LYNDAL HESTERBERG, PH.D. Chief Scientific Officer PADMA SUNDAR Senior Vice President, Marketing/Market Access

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Decision Points Along the Lung Cancer Care Continuum

Oncocyte: Strategically Addressing Lung Cancer Decisions

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Initial Lung Cancer Focus Leverages Strategic Assets

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Lung “Pure Play” Advantages

• Builds toward OCX as one-stop shop for lung cancer

diagnostics

• Economy of scale – leverages OCX sales team,

commercial infrastructure

• Development expertise in lung cancer biomarkers
• Clinical trials recruitment expertise with over 60 current

sites

• Longitudinal patient data from diagnosis to treatment
• Strong KOL representation and advocacy

Opportunity Selection Criteria

• Area of high unmet clinical need
• High degree of scientific confidence
• Serve critical decisions points in clinical oncology
• Reimbursed or reimbursement ready content, or

developing content with market predicate

• High margin
• LDT in U.S., potential to “kit” for ROW

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Three Growth Vectors

Core Asset Development Partnership Opportunities

Complete DetermaDx Validation and initiate prospective trial for claims expansion Initial sales in key territories Reimbursement Explore opportunities with external technologies to offer complete answers at critical decision points Leverage biobank for access to methylation and cfDNA applications High Value Content with current revenue streams and high gross margins Complimentary High Value content for creating lung vertical License Developed Content for OCX Channel Pharma Services lab with High Value content revenues

Mergers and Acquisitions

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DetermaDx Opportunity

Utilizing blood-based Interrogation methods to leverage the immune system’s response to cancer

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Lung Cancer is the Leading Cause of Cancer Death Worldwide

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Detecting Lung Cancer Early is Critical

Detection in Stage I gives 5-year survival comparable to other major cancers

Lung cancer is typically diagnosed in Stage IV, resulting in grim 5-year survival rate

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Lung Cancer Diagnosis

Over 1.6 million patients with lung nodules discovered annually in U.S via screening or incidentally1

Invasive biopsies or surgery of the nodules confirm a cancer diagnosis Home – No Complications Hospitalization after complications

• 1. Gould, et al. (2015) Recent trends in the identification of incidental pulmonary nodules. American Journal of Respiratory and Critical Care Medicine

192:1206.

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Lung Biopsies are Risky and Expensive

DetermaDx is designed to directly address this challenge by reducing unnecessary invasive diagnostic procedures

1 in 5 invasive diagnostic procedures result in complications1 Mean U.S. cost of a biopsy is about ~$15,0002 Mean cost of biopsy with serious complications is greater than $50,0001 96%3 of nodules found through screening are benign, whereas 24%-26%1 of biopsies result in complications

1. Huo, et al., JAMA Internal Medicine 179:324, 2019. 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

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Actionable Answers for a Critical Question in Cancer Diagnosis

DetermaDxTM: Non-Invasive Gene expression classifier with binary call

^ Actual wording of the test report to be sent to physicians has not been finalized

>500,000

High Risk Nodules* found annually

$1.75B

Market opportunity in US alone**

* 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.

^ ^

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How does the Oncocyte Approach Work?

• 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

Oncocyte leverages the exquisite sensitivity of the body’s immune system’s response to early-stage cancer

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What Sets Oncocyte Apart?

Insufficient sensitivity in early-stage cancers Just not enough ‘signal’ to detect

Other Companies

Direct Measurement

Cancer Cells Meth-DNA ctDNA

Oncocyte’s Approach

Immune System Interrogation

Proprietary algorithm utilizing selected mRNA biomarkers Leverages the exquisite sensitivity of the immune system’s response to early-stage cancer “Immune System Interrogation” approach could have broad application across other solid tumors

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DetermaRx

Proprietary Predictive Test for Early Stage Lung Cancer

Oncocyte: Strategically Addressing Lung Cancer Decisions

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Early Stage Lung Cancer Can Be Deadly

~40,000 patients1 are diagnosed with early- stage non-squamous NSCLC in the U.S. annually

30-50% of patients with Stage I & II NSCLC die with within 5 years despite having a complete resection2

Stratifying early-stage patients by recurrence risk has the potential to:

• Identify patients that are likely to benefit from early, post-operative

chemotherapy

• Reduce mortality and cost by preventing recurrences and expensive,

late-stage treatment

• 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.
• 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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The Razor Treatment Stratification Test

• In a published prospective study, DetermaRx demonstrated improvement in disease-free survival

(DFS) when high-risk patients were treated with chemotherapy

• DetermaRx directed chemotherapy was found to prevent the majority of recurrences among high-

risk patients with the potential to save thousands of lives in the U.S. annually

*Prospective study of Stage I-IIA patients (Clin Lung Cancer 2018;19:58)

Targets cytotoxic chemotherapy only to patients likely to benefit from treatment

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DetermaRxTM: Extensively Validated to Dramatically Impact Disease Free Survival for Early Stage Lung Cancer Patients

1. Kratz, et al. (2012). Lancet 379:823. 2. Woodard, et al. (2018) Clinical Lung Cancer 19:58

Kaplan-Meyer plot above includes 100 sequential patients stratified by DetermaRx test.

– Validated in in independent, blinded, global trials with close to 1,400 patients1

• Kaplan-Meyer plot includes 100 sequential patients

stratified by the Razor test

• High-risk patients identified with the Razor Test that went
• n to standard, inexpensive platinum doublet post-
• perative therapy had improvem

ement ent i in 5-yea ear d disea ease e –free s survival rate from 49% t to 92% compared to no chemo high-risk population2 with p-value=0.04.

• Prognostic stratification validated in independent,

blinded, global trials with over 1,400 patients – Outperformed current NCCN criteria in identifying patients likely to recur and therefore benefit from chemotherapy2

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DetermaRx is Commercially Available

Test designed and validated on ThermoFisher QuantStudio

Estimated installed base of >3,000 systems allows global launch on established workflows

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Reimbursement Ready in Untapped Market

Market Overview

• ~ 40,000 Stage I and II non-squamous NSCLC diagnosed in

the US annually1

• Increasing eligible population with adoption of CT screening
• No clear guidelines or test to identify high-risk patients who

could benefit from chemotherapy

• Unprecedented opportunity for pharma to use test to identify

responders in large and growing market for immuno-oncology in early stage disease.

1. Meza, et al. (2015) Lung cancer incidence trends by gender, race and histology in the United States, 1973-2010. PLoS One 10:e0121323. 2. Source: 2016 Centers for Disease Control and Prevention, % of lung cancer patients 65 years and older

Reimbursement Process

• Received CMS proposed Positive LCD Coverage in late

August and expecting Final LCD in early 2020

• CMS approval alone provides coverage for 70% of the US

NSCLC market2

• Similar Gene Expression panels are reimbursed between

$3,000 - $4,000

• Many private payers likely to follow CMS example given

clinical utility and health economic impact

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DetermaRx: Transforming Treatment Stratification in Early Lung Cancer

Treatment Stratification Test identifies early stage lung cancer patients who may benefit from chemotherapy to significantly increase their survival rates Extensively validated and published with independent, blinded global trials including close to 1,400 patients and seven publications in prestigious journals including Lancet and JAMA Recent CMS Positive Coverage Decision indicative

• f the clinical utility of the test

Proposal for incorporation into new staging protocol published in July ‘18 Acquisition allows OCX to transition to a commercial al s stag age compan any i in Q1 2020 Complements DetermaDx decision point Same endpoint that Genomic Health utilized in for their OncotypeDx Breast Test, which resulted in a $2.8B exit Deal structure minimizes capital outlay and aligns Razor Genomics team via participation in revenue growth Prospective, randomized clinical utility trial to start immediately Reduction in mortality will drive rapid adoption ~ 60% of patients can be effectively targeted by a specialized lung cancer sales force

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DetermaIO

Identifying Immunotherapy Responders

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Identifying Immunotherapy Responders

JAMA Netw Open. 2019;2(5):e192535

• Immunotherapy drugs have been

revolutionary – but only for a subset of patients

• Immunotherapy drugs are costly, have

morbid side effects, and only are effective in a fraction of patients

• The development of biomarkers to predict

immunotherapy responsiveness has had limited success

• IHC targets like PDL-1 and tumor mutation

burden (TMB) assays are not standardized with different criteria

• Most trials combine immunotherapy with

cytotoxic chemotherapy, which confounds interpretation of results

• Pharma development strives for least

restrictive label – avoid biomarker subpopulations

Oncocyte: Strategically Addressing Lung Cancer Decisions

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Insight Genetics – Expanding Oncocyte’s Menu for Clinical and Pharma

30 Biomarker and Novel Content Assay Design and Development Assay Validation Clinical Trial Services Regulatory Excellence Commercial Partnership

• Pharma and Diagnostics services

assay design, validation and clinical trial execution

• Proprietary content in molecular

classification of solid tumors

• Experience in IVD assay development
• ISO 9001 2015
• 21 CFR 820 design control
• Class A Supplier for Qiagen (est.

2013)

Insight Genetics Regulatory & Quality Meets Pharma/Diagnostics Requirements

Current Audits and Certifications: Insight Genetics, Inc.

• All assays designed according to the Clinical and Laboratory Standards Institute guidelines.
• ISO 9001 2015 Certification (current; established 2013)
• Approved Class A supplier for QIAGEN (current; est. 2013)
• Allows for Assay Development and Verification Activities
• Good Clinical Practice (GCP) Compliance (since 2017)
• QIAGEN designated Insight Genetics to be one of five commercial laboratories to test Therascreen, the

companion diagnostic to Janssen’s BALVERSA™ (erdafitinib).

• Qualified for clinical trials with major pharma companies
• Incorporates 21 CFR 820 practices by adherence to design control protocols.
• CLIA certification 2013
• CAP accreditation 2016

Insi sight Gen enet etics s is a fully functional Pharma Services La Lab with all certification

• ns to
• suppor

pport immedi diate ou

• utreach to
• ou
• ur ph

pharma networ

• rk and

d suppor pport FDA Trials

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• Classifies immune and inflammatory infiltrate in the context of phenotype of the tumor specimen
• Gene expression classifier trained and extremely well-validated as a classifier
• Immune signature combined with the “stromal” signature was found to identify patients with a

strong response to anti-PDL-1 therapy

• Same signature works in lung and breast cancers (immune response and stromal signature

conserved between solid tumor types)

• In head-to-head comparison with TMB and IHC for PDL-1 consistently superior
• 30 gene real-time PCR assay
• Data-to-date uses 3 major IO drugs - Merck’s Keytruda (Pembrolizumab), BMS’ Opdivo

(Nivolumab), and AstraZeneca’s IMFINZI (Durvalumab) with consistent results

• The IM test studies used tumor, lymph node metastasis, or distant metastasis as the source

suggesting it is not context dependent

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DetermaIOTM – Robust Identification of IO responders

IGI’s Immune-Oncology (IM Score) Test Surpasses ALL Current Predictive CDx Tests

33 P < 0.001 Progressive Disease Stable Disease Partial Response Complete Response Cutoff = 0.09 P-value (spearman) <0.001.

20.4% 41.5 % 44.7 % 47.8 %

PD SD PR CR

Cutoff = 1% P-value 0. 0.20 20

PD SD PR CR

12.1 14.6 10.2 8.5

P = 1

Cutoff = 10 P-value 0. 0.999 999

Compariso son of Objec ective e Resp esponse se with IM Score e and other er test esting met ethods s sh shows s si significant improvem emen ent in iden entifying resp esponder ers s when en usi sing the e IGI IM Score e for IO Ther erapy Sel elec ection

Significant quantitative response to disease response (p<0.001) PDL-1 staining insignificant (p=0.20) TMB insignificant (p=0.99)

IO Abstract presented at SITC in early Nov’19

Rapid Expansion of I-O Trials Presents Solid Market Opportunity Pharma trial revenue generated through differentiated tests to identify IO responders

34 https://pharmaintelligence.informa.com/resources/product- content/immuno-oncology-halfway-to-adulthood 2010 2011 2012 2013 2014 2015 2016 2017 2018 86 127 23 8 43 3 785 61 1 833 12 1 121

• 1.5 I-O trials initiated daily
• Solid market opportunity for Pharma trial

revenue with differentiated test to identify responders

• Insight Genetics has a fully functional

Pharma services lab with all certifications

• Supports immediate outreach to

Pharma network with foundational balance sheet offered by OCX

Insight Acquisition Expands Menu and Establishes Oncocyte as the Leader in Lung Cancer Content for Critical Therapeutic Decisions

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US TAM: ~$1.75B US TAM: ~$140M US TAM: ~$2,2B

Syne nergy of c combine ned o

• ffering

ng a and nd common n call point nts i inc ncreases brand awareness, sales force efficiency and potential for success

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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 DetermaDxTM in development to revolutionize diagnosis, avoiding risky and costly biopsies/surgery DetermaRxTM 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 DetermaIOTM is a potentially transformative immuno-diagnostic test for the selection

• f 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

Upcoming Milestones

• Commercial team built-out in preparation for DetermaRx launch in Q1 ’20
• Full Commercial Launch of DetermaRx in Q1 ‘20
• Final LCD DetermaRx
• DetermaRx clinical utility trial to begin enrollment
• Completion of DetermaDx clinical validation and initialization of clinical utility study
• Close Pharma studies for DetermaIO
• Publish IO data at upcoming AACR and ASCO meetings

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CONTACT US

Oncocyte.com

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