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Advancing Cancer Diagnosis Improving patient outcomes while lowering - - PowerPoint PPT Presentation

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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,

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Advancing Cancer Diagnosis

Improving patient outcomes while lowering health care costs February 2019 NYSE AMERICAN: OCX

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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

  • r 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

  • bligation to update these forward-looking statements, except as required by law.

Except as otherwise indicated, this presentation speaks as of the date hereof.

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Investment Highlights

  • Oncology diagnostics company initially targeting lung cancer

– highest mortality rate

  • DetermaVu™ blood test demonstrates best-in-class

performance

  • $2B-$5B Total Addressable Market with high margin potential
  • Rapid pathway to commercialization (2H 2019)
  • Potential for Immune System Interrogation approach to

address multiple types of cancer

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DetermaVuTM Significantly Improves Standard of Care

Current Standard

  • f Care

The Future with DetermaVuTM

  • Major diagnostic dilemma

for physicians

  • High number of

unnecessary biopsies

  • 24% serious complications
  • High cost
  • Solves diagnostic dilemma
  • Greatly reduces

unnecessary biopsies

  • Reduces cost and

complications

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Advancing the Standard of Cancer Diagnosis

IP Protected gene expression classifier with binary call

Negative Positive

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Lung is One of Largest US Market Opportunities

$2.1B

Initial use

400,000–600,000 Patients with large nodules

$4.7B

Expanded use

1.4 Million Patients with medium to large nodules

Company estimates based on LungRADS guidelines and NLST data, list price comparable to existing molecular diagnostics with algorithm Percepta list price $4,875, Affirma CMS reimbursement $3,100.

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Colorectal Breast

Lung

Prostate Bladder Five-year Survival Rate

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

Detecting Lung Cancer Early is Critical

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

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 1975 1980 1985 1990 1995 1999 2003 2007

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Well-funded PSA Campaign Seeks to Boost Screening Rates in High-Risk Population

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Lung Cancer Detection Process

If medium/large nodules are found, biopsy carried out Home ICU 10 – 15M smokers should get annual Low Dose CT scans

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Lung Biopsies are Risky and Expensive

  • Lung biopsies are much riskier than other cancer biopsies
  • Up to 1% result in death
  • 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 DetermaVuTM is designed to directly address this challenge by reducing unnecessary biopsies

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Successful R&D Validation Study

  • Demonstrates best-in-class performance
  • Blinded results from 250 sample prospective

cohort demonstrate excellent performance

  • Sensitivity: ~90% (95%CI 82%-95%)
  • 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

  • pens the door for high-value strategic opportunities

ROC Curve

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Capital-Efficient Commercialization Plan

  • Capital on hand is sufficient to reach commercialization
  • Efficient and focused sales and marketing plan
  • ~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
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Commercialization strategy addresses all key stakeholders

Benefits Marketing Strategy

  • Determinate diagnosis
  • High sensitivity,

specificity

  • Reduce unnecessary

biopsies

  • Earlier detection
  • Improved outcomes
  • Reduce anxiety over

indeterminate finding

  • Improved health
  • utcomes
  • Fewer unnecessary

procedures

  • Reduce overall costs

✓ Medical conferences exhibits and symposia ✓ Specialty sales force ✓ Speakers bureau ✓ Peer reviewed publications ✓ Practice Guidelines ✓ Increase awareness to increase LDCT uptake ✓ Patient friendly test report ✓ Patient assistance program ✓ Aim for highest level

  • f evidence in

clinical trials ✓ Contracting strategy aligned to value added pricing ✓ RWE Clinical utility studies ✓ CMS 1st Coverage focus

Timing

  • Begin at commercial

availability

  • Begin at

commencement of clinical utility study

  • Begin upon

successful completion

  • f Clinical Validation
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Payers View DetermaVu™ Very Favorably

  • Previewed intended use and clinical development plan with medical

directors from 10 public and commercial payers

  • 77M Covered lives
  • Positively received
  • All recognized the large unmet medical need DetermaVuTM

addresses

  • Expressed strong support for DetermaVu’s clinical development plan
  • Indicated high level of interest in reimbursing DetermaVuTM if studies

successful

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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

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What Sets OncoCyte Apart?

Direct Measurement

ctDNA Meth- DNA Cancer Cells Grail, Guardant, Freenome, Exact, Veracyte…

Immune System Interrogation

OncoCyte’s Approach

Insufficient sensitivity in early- stage cancers Just not enough ‘signal’ to detect Leverages the exquisite sensitivity of the immune system’s response to early-stage cancer

Immune System Interrogation approach could have broad application:

  • Other cancers
  • Chronic diseases
  • Infectious diseases

Proprietary algorithm utilizing selected biomarkers

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Why does the OncoCyte Approach Work?

Implicated in immune response to cancer

OncoCyte leverages the exquisite sensitivity

  • f the body’s

immune system’s response to early- stage cancer

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  • 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

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Investment Highlights

  • Oncology diagnostics company initially targeting lung cancer

– highest mortality rate

  • DetermaVu™ blood test demonstrates best-in-class

performance

  • $2B-$5B Total Addressable Market with high margin potential
  • Rapid pathway to commercialization (2H 2019)
  • Potential for Immune System Interrogation approach to

address multiple types of cancer

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Advancing Cancer Diagnosis

Improving patient outcomes while lowering health care costs

NYSE AMERICAN: OCX

Company Contact: Mitch Levine, Chief Financial Officer mlevine@oncocyte.com

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Appendix

NYSE AMERICAN: OCX

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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)

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Genetic Pre- Disposition

Diagnosis of Cancer Post-Diagnosis

Screening Recurrence Detection Diagnostics for Targeted Therapies Diagnosis Recurrence Risk Predictor

Cancer Diagnostic Continuum

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DetermaVu™ will Provide Critical Information in Area of Greatest Need

Pre-DetermaVu Risk-level

Low Risk

Determined by nodule size, age, smoking history and other factors

SERIAL IMAGING

Low Risk High Risk

BIOPSY & Other Procedures

Post-DetermaVu Risk-level

High Risk Intermediate Risk Negative Result Suspicious Result

>3cm 0.8-3cm <0.8cm

Lung Nodule Detected

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Validation Plan for DetermaVu™

R&D Validation ➢ Confirms algorithm performance on a blinded sample set in an R&D setting Analytical Validation ➢ Establishes the performance characteristics of the assay system to be validated in the CLIA laboratory CLIA Validation ➢ Confirms that the assay has been successfully transferred to the CLIA laboratory Clinical Validation ➢ Establishes the product performance claims in an independent, blinded sample set Clinical Utility ➢ Demonstrates a net improvement in patient

  • utcomes or similar outcomes at a lower price
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CLIA Regulatory Pathway in Place

Dx Test CLIA

LDTs only

FDA FDA PMA

Class III

FDA 510(k)

Class I / II

  • Ensures high

quality testing standard

  • Studies

demonstrate safety and efficacy

  • Ensures safety

and efficacy of diagnostic

  • Cologuard
  • For LDTs, 510(k)

is redundant pathway to CLIA

  • Prosigna (IVD kit)
  • AlloMap (LDT)

1 2 3

Depends on FDA risk-class

  • CLIA offers the quickest and least-risk path to commercial availability
  • For our tests, FDA offers no commercial advantages, either for adoption or

reimbursement

  • OncoCyte’s laboratory received CA CLIA certification August 2017

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