advancing cancer diagnosis - oncocyte/media/files/o/... · $2.1b-$4.7b total addressable market...
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Advancing Cancer DiagnosisImproving patient outcomes while lowering health care costs
June 2019 NYSE AMERICAN: OCX
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Forward looking statementsThis 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.
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Investment Highlights
• Oncology diagnostics company initially targeting lung cancer – highest mortality rate
• DetermaVu™ blood test demonstrated best-in-class performance in R&D Validation study
o $2.1B-$4.7B Total Addressable Market with high margin potential
o Rapid pathway to commercialization (2H 2019)
• Immune System Interrogation merits further exploration for use in multiple types of cancer
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Lung is One of Largest US Market Opportunities in Cancer Diagnostics
$2.1B
Initial use~520k Patients with large
nodules (>8mm)
$4.7B
Expanded use~1.2 Million Patients with medium to large nodules
(>5mm)
Company estimates based on LungRADS guidelines (2014) and NLST data, list price comparable to existing molecular diagnostics with algorithm Percepta list price $6,400, 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
American Cancer Society Cancer Facts and Figures 2017; Cancer SEER Stat Fact Sheets; NCCN Guidelines Lung Cancer Screening (February 2014); USPSTF Guidelines for Lung Cancer (December 2013).
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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 (8 – 30 mm) are found, biopsy carried out
Home
ICU
Current and former smokers should get annual Low Dose CT screeningAbout 1.5 million patients with lung nodules discovered annually in U.S.
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Lung Biopsies are Risky and Expensive
• Lung biopsies are much riskier than other cancer biopsieso Up to 1% result in deatho Up to 24% result in serious complications
• Mean U.S. cost is about $15,000 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
Huo, et al. JAMA Internal Medicine, 2019 https://www.jwatch.org/fw112499/2017/01/31/lung-cancer-screening-real-world-has-high-false-positiveSources: Gould, MK et al. Evaluation of Individuals with Pulmonary Nodules: When is it lung cancer? CHEST 2013; 143(5)(Suppl):e93S-120S; OncoCyte absolute number estimated using TAM 12.6M and 75% specificity; Lokhandwala, T et al. Costs of Diagnostic Workup for Lung Cancer – A Medicare Claims Analysis. ASTRO Abstract presented Thursday, October 20, 2014.
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DetermaVuTM is Expected to Significantly Improve Standard of Care
Current Standard of Care
The Future with DetermaVuTM
• Major diagnostic dilemma for physicians
• High number of unnecessary biopsies
• 24% serious complications• High cost
• Addresses diagnostic dilemma• Potential to greatly reduce
unnecessary biopsies and related costs and complications
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Advancing the Standard of Cancer Diagnosis
Gene expression classifier with binary call
“Likely Benign”
“Suspicious”
*Actual wording of the test report to be sent to physicians has not been finalized
*
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Successful R&D Validation Study
• Demonstrates best-in-class performance • Blinded results from 250 sample* prospective
cohort demonstrate excellent performanceo Sensitivity: ~90% (95%CI 82%-95%)
o Specificity: ~75% (95%CI 68%-81%)
• Significantly outperforms reported results from clinical models and all competitors’ tests**
• No clinical data (e.g. nodule size) utilized; results from biomarkers alone
Proof-of-concept of Immune System Interrogation approach opens the door for high-value strategic opportunities
ROC Curve
*All samples were from patients with nodules ranging from 5mm-30mm**“Competitors: https://www.biodesix.com/products/bdx-xl2/ , https://magarray.com/reveal/*
DetermaVuTM Phased Commercialization Plan
• LDT Availability: Clinical Validation through Paper Publication• Ramp Up: Publication through Medicare coverage decision• Full Commercialization: Post Medicare coverage
12 Confidential
Payers View DetermaVu™ Very Favorably
• Previewed intended use and clinical development plan with medical directors from 10 public and commercial payers o 77M Covered liveso 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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Broad Implications of Immune System Interrogation Approach
• OncoCyte’s study is the first ever to demonstrate the ability to utilize immune response to diagnose early-stage cancer*
• Proof of concept for further exploration of use across multiple cancer types
• Immune System Interrogation approach leverages the exquisite sensitivity and response of immune system to detect early stage cancers
*From R&D Validation study conducted using patients with lung nodules 5mm-30mm in size
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What Sets OncoCyte Apart?
Direct Measurement
ctDNA Meth-DNA
Cancer Cells
Other Companies
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 across other solid tumors
Proprietary algorithm utilizing selected biomarkers
Why does the OncoCyte Approach Work?
Implicated in immune response to cancer
OncoCyte leverages the exquisite sensitivity of 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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Capital-Efficient Commercialization Plan
• Capital on hand to commercialize DetermaVu and fund additional R&D efforts
• Efficient and focused sales and marketing plano ~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• May reduce
unnecessary biopsies
• Earlier detection• Improved outcomes• Reduce anxiety over
indeterminate finding
• Improved health outcomes
• 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
Easy to read test report
Patient assistance program
Aim for highest level of evidence in clinical trials
Contracting strategy aligned to value added pricing
RWE Clinical utility studies
CMS 1st Coverage focus
Timing • Begin upon successful completion of Clinical Validation
• Begin at commencement of clinical utility study
• Begin upon successful completion of Clinical Validation
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Investment Highlights
• Oncology diagnostics company initially targeting lung cancer – highest mortality rate
• DetermaVu™ blood test demonstrated best-in-class performance in R&D Validation study
o $2.1B-$4.7B Total Addressable Market with high margin potential
o Rapid pathway to commercialization (2H 2019)
• Immune System Interrogation merits further exploration for use in multiple types of cancer
Advancing Cancer DiagnosisImproving patient outcomes while lowering health care costs
NYSE AMERICAN: OCX
Company Contact: Mitch Levine, Chief Financial Officer [email protected]
Appendix
NYSE AMERICAN: OCX
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Lung Cancer: Highest Mortality Rate
234,030New diagnoses
154,050Deaths
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
TherapiesDiagnosis
Recurrence Risk
Predictor
Cancer Diagnostic Continuum
DetermaVu is intended to be used along with other factors by the physician to aid in the diagnosis of lung cancer
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Validation Plan for DetermaVu™
R&D Validation(Completed)
Confirms algorithm performance on a blinded sample set in an R&D setting
Analytical Validation (Completed)
Establishes the performance characteristics of the assay system to be validated in the CLIA laboratory
CLIA Validation(Initiated)
Confirms that the assay has been successfully transferred to the CLIA laboratory
Clinical Validation(Pre-launch)
Establishes the LDT performance claims in an independent, blinded sample set
Clinical Utility(Post-launch)
Demonstrates a net improvement in patient outcomes or similar outcomes at a lower price