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Game changing facility in Cancer Diagnostics and Treatment

now available at RGCI & RC in collaboration with

Star Health Network and associated partners

(THOMAS JEFFERSON UNIVERSITY - KIMMEL CANCER CENTER & YALE SCHOOL OF MEDICINE )

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Precipio DiagnosticsPrecipio \pri-sip-E-O\ verb (Latin): 1. to anticipate 2. to advise

Yale Tumor Profiling Training Session

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Agenda

1. Our Vision 2. Targeted Customers3. Tumor Profiling

– Case study– Background & Philosophy of the Tumor Profile lab and Dr. Sklar, Founder/Medical

Director – Molecular Diagnostic testing– Current alternatives/Competition– Tumor Profile Technical specifications– The Report– Key competitive advantage elements– Competitive analysis, advantages & differentiations– Requisition & Logistics– Billing

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Our Vision

Create the highest standard of diagnostic quality by harnessing academic intellect, expertise, and technology, and

delivering it to benefit the patient

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Targeted Customers

1. Community-based oncologists2. Hospitals (pathologists supporting the oncologists for molecular testing)3. Reference Laboratories4. Surgical Centers

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Case study

• 73-year old female patient in Memphis, TN• Diagnosed with Lung Cancer, estimated 6 months left• Underwent two failed chemotherapy treatment courses• Precipio sales executive visited the treating oncologist• Yale Tumor Profiling lab introduced• Oncologist agreed to try the test, Patient biopsy sent to Precipio for diagnosis• Yale Tumor profiling panel conducted on patient specimen• An actionable mutation was found• Patient put on new treatment course that would otherwise not have been

considered• Patient now anticipated to have another 1-3 years

Treating physician: Dr. Gregory FranzPractice: Boston Baskin Cancer Center, Memphis, TNDate of report: March 27, 2012

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MDx testing – current options

• Once patient tumor diagnosed with cancer (surgical pathology performed), MDx ordered to identify specific treatments– E.g. – EGFR for lung cancer – positive diagnosis responsiveness to erlotinib

• Oncologist/pathologist sends the tissue to outside MDx lab• Economics of PCR MDx cause batching TAT of 10-14 days. • Commercial high-throughput labs have high level of QNS (~25%)

Individual gene testing: Economic Focused Pathologists are comfortable with this- Pinpoint vs. comprehensive- Repeat ordering- Reliant on physician current knowledge- Time/cost/tissue inefficient

NGS testing: Most advanced technology Scalable and comprehensive Forward-looking- Information overload- Non-actionable information- High bill- Potential legal liability

Yale TP: Comprehensive and updated Actionable-only information Time/cost/tissue efficient

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Background & Philosophy of Tumor Profile Lab

• Oncologists want results that drive treatment• Practical, easy-to-read report with pertinent information• Affordable and responsible costs• Jeff Sklar, MD, PhD

– Director of Molecular Diagnostics at Yale– Chief Scientific Officer at Precipio– Trained at Harvard, Stanford, Yale– Pioneer in the field of diagnostics– Discovered the Immunoglobulin Gene Rearrangement (B-Cell Lymphomas)

• The inherent conflict of personalized medicine:– “If you don’t go looking in unexpected places, you’ll never find it”

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Tumor Profile Technical Specifications

• Platform – Taqman Array– Closed environment to reduce contamination– Higher level of accuracy– Cost Effective (No Batching)

• Genes tested– More mutations examined per gene than conventional PCR

• Stage & Reflex approach– Genes mutually exclusive– Start with most prevalent, continue to rarer mutations

• Laser Capture Micro-dissection– Extract tumor cells from tissue– Performed by Yale trained MD, PhD (Dr. Walther)– Allows for processing of virtually any type of sample submitted

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Tumor Profile Report

• Clear, actionable diagnosis• Personalized reporting

– Responsive/Non responsive Treatment alternatives– Relevant clinical trials

• 3 pages

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Key competitive advantages

1. Actionable diagnosis– Literature-supported actionable mutation analysis

2. Tumor-tailored panels– Comprehensive mutation-testing panels– Continuously updated– Staged / Reflex approach

3. Responsible billing– Stage/reflex reduces insurance bills– Testing & Reporting ONLY of actionable genes – Approved by Medicare & private payers

4. Rapid Turnaround time – 7-10 days5. Tissues accepted

– All tissue forms– Minimal tissue quantities required– No QNS !!

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Comparative Analysis

Factor Yale TP Competition

Genes selected Actionable only Insufficient/overkill

Mutations run All known mutations, updated Limited, lagging

TAT 7-10 days max 10-14 days minimum

Billing - Responsible/minimal, controlled thru Stage/Reflex

- Approved by Medicare/Private

- MDX Cheaper than TP- TP cheaper than NGS- Risk of patient bill

Tissues tested - All tissues- Minimal quantities

- Usually FFPE only- 25% QNS

Personalized Relevant drugs & Clinical trials Relevant drugs

Hassle factor - Low – Physician can order comprehensive without specifying genes

- PDX requests tissue from Path

- High – Physician needs to specify order, remain “on top” of discoveries

- Practice needs to request tissue

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Tumor Profile Requisition and Logistics

Requisition form - 3 sections:1. Physician & patient information2. Test selection

– Comprehensive (Omnia) – Yale pathologist will determine the correct panel– Specific tumor-type test

• Comprehensive for that tumor• Specific genes relevant to that tumor

3. Pathology– Customer/office to provide contact info where biopsy is located– Important: Sales person should introduce Precipio to the pathology group – Precipio will material-request the biopsy directly – avoiding office handling

• Logistics:– Materials sent to Precipio– 7-10 day TAT

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Marketing materials

• Requisition form• Sample report• TP Overview (silhouette) • TP vs. standard molecular• TP flow chart for NSCLC & CRC• Case studies (coming soon)

• Additional materials:– The Cancer Journal Article authored by Jeff Sklar & Zenta Walther– TP introduction package (15-page PDF intro)– Technical validation package (152-page technical info package)