oncotracker james berenson, md president and ceo november 2014

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OncoTracker James Berenson, MD President and CEO November 2014

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Page 1: OncoTracker James Berenson, MD President and CEO November 2014

OncoTrackerJames Berenson, MDPresident and CEO

November 2014

Page 2: OncoTracker James Berenson, MD President and CEO November 2014

Institute for Myeloma and Bone Cancer Research (IMBCR) spin-out (founded in 2014)

Our discovery: a marker for multiple myeloma known as BCMA

We developed a simple assay to measure BCMA from a blood sample

BCMA is a better marker than current gold standard for myeloma

Potential initial market opportunity: $559M

Future markets include many common cancers (leukemia, lymphoma)

Revenues will start in 2015

Cash flow positive in 2016

Currently Financing $300k via Convertible Note Finalize assay for testing Organizae Lab for CLIA certification Complete Business Plan for $3mm Share Sale

Overview of OncoTracker

Page 3: OncoTracker James Berenson, MD President and CEO November 2014

Tumor Markers Patients’ genes and proteins are increasingly being measured to

diagnose and manage their cancers Examples: BRCA1, HER2/neu, Oncotype DX

These markers can help in designing personalized treatment

Page 4: OncoTracker James Berenson, MD President and CEO November 2014

The Ideal Tumor MarkerTesting requirements:

Easily available source of tissue – e.g., blood sample

Simple and reproducible test Accurate

Clinical requirements:Found in nearly all patientsAccurately correlates with disease to:

Predict patient outcomeMonitor response to treatment

Page 5: OncoTracker James Berenson, MD President and CEO November 2014

Our Focus: Multiple Myeloma

Common cancer of the bone and bone marrow24,000 new cases annually in

USOver 100,000 patients in US

Bone fractures, pain, kidney failure, etc.

Many frail and elderly patients

Median survival of 7 years

Page 6: OncoTracker James Berenson, MD President and CEO November 2014

Treating MyelomaMany treatment options available

todayInitial status of disease important in

treatment planRequires a tailored approach based on

prognosis

An accurate and predictive tumor marker has potential to play a major role in this disease

Page 7: OncoTracker James Berenson, MD President and CEO November 2014

Approach to Treatment Depends on Initial Status

20%

10%

70%

Aggressive Disease - Patients Need Immediate Therapy _x000d_Smoldering - Wait and See ApproachIn Between

Page 8: OncoTracker James Berenson, MD President and CEO November 2014

Current Treatments Large number of drugs used today: Velcade, Kyprolis, Revlimid,

Thalomid, Pomalyst, Dexamethasone, Medrol, Prednisone, Cytoxan, Doxil, Trisenox, Melphalan, Oncovin, Treanda, and Adriamycin

These are often combined together resulting in many different treatment regimens

Ideally, administer therapy that: Keeps the disease under control

AND Has the least side effects

Treatments are designed based on patients’: Disease status General characteristics (age, overall health, etc.)

Page 9: OncoTracker James Berenson, MD President and CEO November 2014

Challenges of Treating Myeloma

Three major questions that need to be addressed: Who needs treatment? (Diagnostics) Will it be effective? (Prognostics) How can we track it? (Monitoring)

Answering these questions guides therapy: Starting treatment that is appropriate for the patient Enabling therapy to be modified if necessary

Get off drugs that are not working – reduces exposure to toxic agents Move to alternative therapies

Allowing patients to remain on effective drugs

Tumor markers have the potential to help address these questions and guide treatment

Page 10: OncoTracker James Berenson, MD President and CEO November 2014

The Gold Standard Myeloma Marker:

M-Protein

A protein secreted by myeloma tumor cells

Testing: simple and straightforward Routine blood

and/or urine sample

Standard assay for measuring proteins

Elevated levels in myeloma patients

Page 11: OncoTracker James Berenson, MD President and CEO November 2014

M-Protein Has Limitations for Clinical Uses

Diagnosis: 5-10% of patients do not have measurable M-protein

Prognosis: levels do not predict patient outcomes

Monitoring: levels change slowly over timeDifficult to assess current

disease stateProblematic to track cancer

and modify treatment

Page 12: OncoTracker James Berenson, MD President and CEO November 2014

Our Solution – BCMA

We discovered that a protein, BCMA, was a tumor marker for myeloma Shed from tumor cells into

the blood Correlates with disease status Accurately measures the

current disease status Can be used to quickly

determine response to treatment

Based on research conducted at the IMBCR

Page 13: OncoTracker James Berenson, MD President and CEO November 2014

Our Solution – BCMA Assay

We developed a simple test to measure BCMA levelsRequires small blood

sampleRoutine testing formatStandard instrumentAccurate and

reproducible results

Page 14: OncoTracker James Berenson, MD President and CEO November 2014

BCMA Tracks w/ M-Protein Levels in Individual MM Patients

Page 15: OncoTracker James Berenson, MD President and CEO November 2014

BCMA Can Be Used to Track a Multiple Myeloma Patient without M-Protein

Page 16: OncoTracker James Berenson, MD President and CEO November 2014

BCMA Levels Predict Treatment Response% factor of control

Ronald Berenson
This and next slide should be combined into one slide with two figures. The one here, but simply reduced to the median values with the ranges. All of these dots are not helpful. Aso, no one has any idea what is meant by responsive disease and progressive disease.
Page 17: OncoTracker James Berenson, MD President and CEO November 2014

Serum BCMA Levels are Higher in Multiple Myeloma Patients than MGUS or Controls

BCMA Levels Correlate With Disease Status

Ronald Berenson
Same type of comments apply to this figure which should be combined with the last into one slide together. Again, just show median lines and error bars. No need to show all of those dots.
Page 18: OncoTracker James Berenson, MD President and CEO November 2014

Progression Free and Overall Survival Rates in Multiple Myeloma Patients

Median progression free survival following first treatment: 2 years

Importantly, progression-free survival shortens with each subsequent treatmentThus, finding out quickly that treatments are not

working becomes of increasing importance

Median overall survival: 7 years

Page 19: OncoTracker James Berenson, MD President and CEO November 2014

BCMA Predicts Progression Free Survival During Frontline Treatment

Page 20: OncoTracker James Berenson, MD President and CEO November 2014

BCMA Predicts Progression Free Survival During Salvage Therapy

Page 21: OncoTracker James Berenson, MD President and CEO November 2014

BCMA Predicts Overall Survival

Page 22: OncoTracker James Berenson, MD President and CEO November 2014

Market For Current Diagnostic Tests

Laboratory tests Blood- SPEP, quantitative immunoglobulins, serum free light

chains Urine- UPEP w/ 24-hour urine total protein Routine CBC and chemistries Beta-2-microglobulin

Bone marrow aspirate and biopsy Pathology Genetics- cytogenetics, fluorescent in situ hybridization,

genetic expression profiling

Bone imaging- X-rays, MRI, PET CT scan

Page 23: OncoTracker James Berenson, MD President and CEO November 2014

Market for Tests to Monitor Myeloma

Routine testsBlood- SPEP, quantitative immunoglobulins, serum

free light chainsUrine- UPEP w/ 24-hour urine total protein

SpecializedNew bone disease- MRI, PET CT scan Bone marrow

Page 24: OncoTracker James Berenson, MD President and CEO November 2014

How Does it Compare to Other Markers?

Cost Ease of Testing

Diagnosis

Prognosis

Monitoring

M-Protein + + + - +/-

Beta-2 microglobul

in

+ + - - -

Bence Jones protein

+ - - - +/-

Bone marrow biopsy

- - + - -

Radiology - - - - +

BCMA + + + + +

Page 25: OncoTracker James Berenson, MD President and CEO November 2014

Increasing Size of Cancer Market

Estimated at 5% Per Year

Bill

ions

USD

2014 2015 2016 2017 2018 20190

20

40

60

80

100

120

140

Page 26: OncoTracker James Berenson, MD President and CEO November 2014

Rapidly Growing Tumor Marker Market

Estimated at 18.1% Per Year

Bill

ions

USD

2014 2015 2016 2017 2018 20190

1

2

3

4

5

6

7

Page 27: OncoTracker James Berenson, MD President and CEO November 2014

Multiple Myeloma Market

24K new patients per year

100K patients per year

$4.4B market for multiple myeloma drugs in USA

Patients undergo monthly testing to monitor disease

Total of 1.3M evaluations for 100K patients1.3M M-Protein measurements6.5M total tests: battery of 5 tests, including M-

Protein