OncoCyte is focused on early diagnosis the largest market segment - - PowerPoint PPT Presentation

Source of revenue: The 2015 Liquid Biopsy Report Piper Jaffrey (September 2015).

Recurrence $6.9B Companion Diagnostics $6.7B Diagnosis $15B Prognostic

OncoCyte is focused on early diagnosis – the largest market segment with less competition

1

Prognosis Diagnosis $15B Companion Diagnostics $6.7B Recurrence $6.9B

OncoCyte is focused on areas of greatest unmet need and most attractive margins

2

Health Outcomes is a proxy for clinician unmet need; Cost Savings is a proxy for payer unmet need.

Lung Confirmatory $3.9 Colorectal $3.2 Breast Confirmatory $5.4 Ovarian $.2 Thyroid $.4 Prostate $.6

• 50%
• 30%
• 10%

10% 30% 50% 70% 90% 110% 130% 0% 5% 10% 15% 20% 25% 30% 35% 40% Health Outcomes (5-year death rate) Cost Savings

Product Contribution Opportunity ($Bs)

C

Bubbles represent product contribution opportunity = gross revenue (# of patients * diagnostic price) * estimate of product margins

Ability to avoid unnecessary and expensive follow-up procedures (Probability of false-positive test under current standard of care)

Estimated Margins 25% Primary Care focus 50% Primary Care and Specialty 75% Specialty Care focus

3

Pipeline diagnostics based on gene expression classifier and binary call

Diagnostic Strategy

*Potentially malignant, clinician to determine follow-up procedure.

Sources: Cancer SEER Stat Fact Sheets; NCCN Guidelines Lung Cancer Screening (February 2014); USPSTF Screening Guidelines for Lung Cancer (December 2013).

4 Colorectal Breast Lung Prostate

FDA approval for prostate progression test FDA approval for prostate screening test

Bladder Five year survival rate

Lung cancer is typically diagnosed at later stages, limiting survival rates

57% of lung cancer diagnoses are made in stage IV

Lung opportunity driven by poor outcomes with little improvement over the last 40 years

Post-LDCT biopsies are risky and expensive

For an average patient, a lung biopsy has a higher likelihood of leading to a serious complication than that of confirming lung cancer

• Lung biopsies – via needle, bronchoscopy or

surgery – are much riskier than other biopsies

• Mean cost of $14,634 per biopsy
• Frequent LDCTs expose patients to potentially

unnecessary radiation

Incidence (%) Complication Annual Events (~#) 0.5–1% Mortality 600–1,300 4–20% Major Complications (including collapsed lung) 5,000–26,000

Sources: 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 10M and 65% specificity; Lokhandwala, T el al. Costs of Diagnostic Workup for Lung Cancer – A Medicare Claims Analysis. ASTRO Abstract presented Thursday, October 30, 2014.

5

TAM Numbers based on company estimates and secondary data: 7-10 Million screening patients (USPSTF, NCI); 4.9 Million patients with incidental nodules (Gould MK, et al. Am J Respir Crit Care Med 2015 Nov 15; 192 (10):1208-1214).

Large market opportunity for lung tests

Lung Imaging Studies

USPSTF and Incidental Nodules

All indeterminate diagnoses (LDCT +) Downstream procedures performed on indeterminate diagnoses

Lung-RADS 3, 4a and 4b (~1.4 Million Patients) Overall Lung Nodule Market (12–15 Million Patients) Lung-RADS 4a and 4b (~400,000–600,000 Patients) 1st Launch

6

Expanded Use

7

High-risk patients LDCT screening Clear Biopsy Malignant Benign nodule Follow-up LDCT scans Nodules

Confirmatory

OncoCyte’s initial focus is on a confirmatory diagnostic solution

No nodules

Additional 5M Americans

30 Pack-year history USPSTF Guidelines recommended screening – covered by Medicare

7–10M Americans

Incidentally detected nodules

Current standard of care is not meeting needs of many women

• Mammograms perform poorly for one out of six women

– Dense breast tissue (sensitivity 62-69%) – BRCA mutation positive (adjunctive MRI) – Family history (adjunctive MRI)

• Guidelines recommend annual screening

– Mammogram – Follow-up MRI or ultra-sound

• Number of unnecessary procedures putting burden
• n system

– About 1.7M breast biopsies are performed annually – Cost of unnecessary procedures ($2.8B from false-positive mammograms)

• Creates confusion and uncertainty in women

– “Angelina Jolie effect” – Increase in number of prophylactic mastectomies

Source: ACOG Guidelines; ACOG Committee Opinion March Number 625 (March 2015); Journal Health Affairs (April 2015).

8

Breast confirmatory diagnostic second product focus due to high unmet need

Follow-up MRI

9

Two potential intended use profiles

• Confirmatory for suspicious

mammograms

• Adjunct for high-risk patients

TAM numbers based on company estimates and secondary data

10

Large market opportunity for breast cancer diagnostic tests for specific patient profiles

Guidelines suggest annual mammogram screen Guidelines suggest MRI (dense tissue, BRCA, family history) Indeterminate mammograms

Supplemental screening test (6 Million Patients) and/or Overall screening market (39 Million Patients in 2016) Confirmatory test (1.6–1.9 Million BI-RADS 3-4)