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Biotheranostics Overview  Commercial stage molecular diagnostics company  CLIA and CAP accredited lab based in San Diego,  129 employees  Recently spun-out of bioMérieux; VC backed  Two high value proprietary tests on the market, addressing large unmet medical needs  Only one of three companies to have two tests approved for Medicare coverage through the MolDX process, which are subject to specific coverage criteria set forth in a Local Coverage Determination (LCD).  Entering a period of rapid growth



Biotheranostics History BCI obtains
Breast Cancer
AviaraDx
Medicare
Index (BCI)
acquired by
Coverage (LCD)
biomarker
bioMérieux &
CTID obtains
$32M funding
discovery
Medicare
and spinout
clinical studies bioT3
initiated
coverage (LCD)
published released
2004 2006 2008 2010 2011 2012 2013 CancerTYPE ID
Commercial
Commercial
launch of
commercial
clinical studies
ramp for BCI
biomarker
launch for
published
discovery
CTID & BCI
initiated
economics
studies published



Our Organic Growth Strategy in a Nutshell Levers of Growth  Decision impact & health economic studies to support commercial payers contracts  Customer experience (lab ops & client services)  Expanding BCI's indications (e.g., chemo prediction, neo adjuvant, metastatic)  Cash collection & appeals reimbursement  ASP  Our Advanced Molecular Tests Target Large Unmet Medical Needs, Cancer Patient Populations and Markets US Market Size
& Penetration
• Molecular classifier & diagnosis patients per year for • Biomarkers linked to targeted first line treatments for metastatic cancer patients per year • Early & late recurrence risk 500k prevalent pool • Likelihood of benefit from endocrine treatments Source: Mattson-Jack Cancer !Mpact database (2014)
Patient Journey for Early-Stage, ER+ Breast Cancer Diagnosis
Long-term treatment
Chronic endocrine
treatment (5-10 years)
Treatments
Radiation
Incidence
Prevalence between
years 3-8
early-stage
patients)
Source: Physician interviews, Mattson-Jack Cancer Mpact database (2014)
Challenging Risk vs. Benefit Profile Of Endocrine Drugs Complicates Decision-Making  ATLAS Trial1 (Tamoxifen for 10y vs 5y)
MA.17 Trial4 (Extended letrozole vs placebo)
For every 600 women treated,
For every 600 women treated,
16 recurrences were prevented
12 recurrences were prevented
At the cost of 2-3
At the cost of 5-9
13 new cases osteoporosis
5 endometrial cancers
+ Long term side effects
+ Long term side effects
4 bone fractures
2 pulmonary emboli
and QoL impairment2-3
and QoL impairment
1 thromboembolic event
1. Davies C et al., Lancet. 2013 ;381(9869):805-16. 2. Nolvadex prescribing information. 3. Conzen, SD. Managing the side effects of tamoxifen. In: UpToDate, Dizon DS (Ed), UpToDate, Waltham, MA. (Accessed on March 11, 2015.) 4. Goss PE et al., N Engl J Med 2003;349. 5.Arimidex prescribing information. http://www1.astrazeneca-us.com/pi/arimidex.pdf 6. Femara prescribing information. 7. Aromasin prescribing information. 8. Fallowfield LJ, et al. Breast Cancer Res Treat. 1999;55(2):189-99. 9. Crew KD, et al. J Clin Oncol. 2007 Sep 1;25(25):3877-83. Clear Unmet Medical Need To reliably identify which patients are likely to benefit from extended endocrine therapy and which are not 5 endometrial cancers
+ Long term side effects
13 new cases osteoporosis + Long term side effects
2 pulmonary emboli
and QoL impairment2-3
4 bone fractures
and QoL impairment
1 thromboembolic event
Addressing a Key Unmet Medical Need There is only one validated predictive test available today: Sept 2013 Lancet Oncology
Editorial

"So, is the BCI test ready
for prime time
in treatment
decision making for women who
have undergone 5 years of
hormonal therapy?
The answer is yes."
"The BCI test has level 1B evidence for this indication." Second Generation Molecular Diagnostic Test With Two Components BCI Prognostic
BCI Predictive
Assesses Individual Risk of Predicts Likelihood of Benefit Recurrence from 0-10 years From Hormonal Therapy Initial focus is on the area of greatest unmet need:
Benefit from extended Late recurrence risk (5-10 yrs) endocrine therapy (5-10 yrs) Clinically Actionable Information that can impact her treatment plan Low Risk/Low Likelihood of Benefit
Consider completion of endocrine Rx at 5 years
For patients already on extended endocrine Rx, consider stopping
High Risk/High Likelihood of Benefit
Consider extending endocrine Rx beyond year 5
For patients beyond year 5 who are off treatment, consider restarting
endocrine Rx
Emphasize importance of compliance and adherence
High Risk/Low Likelihood of Benefit
Consider additional and other therapeutic approaches for risk
reduction and more frequent monitoring
Low Risk/High Likelihood of Benefit
Consider continuation of endocrine Rx beyond year 5 if patient is
tolerating well and has no concerning comorbidities
 % of patients based on clinical trials and clinical experience.  *For node-negative patients. BCI Prognostic was validated in a cohort that included LN- patients only. Any LN+ patient should be viewed as higher risk and managed accordingly.  For all patients, clinical decisions require incorporation of BCI results with all other clinicopathologic factors The Breast Cancer Index Protocol Patient Tissue
Tumor dissection
Sample (FFPE)
Individualized risk of late recurrence • Algorithm evaluates patient's
gene expression profile
Interrogates estrogen signaling(1)
and proliferative(2) pathways
BCI Predictive (H/I ratio) (1) Biomarker: HoxB13/IL17BR (H/I) gene
expression ratio
Predictive of likelihood of benefit (2) Biomarker: Molecular Grade Index (MGI)1,
from extended endocrine therapy which includes 5 cell cycle genes (BUB1B, CENPA, NEK2, RACGAP1, RRM2) High or Low (binary result) BCI Sample Test Report Breast Cancer Index Supported by Robust Clinical Evidence Integration into clinical practice
Pivotal studies (2013)
Oncology
Clinical
Clinical
Validity
Analytical
Economics
Technical robustness of biomarker
Health and cost effectiveness
Validity
Outcomes
BCI Pivotal Studies The BCI clinical study program has demonstrated:  Risk Assessment for Early and
• BCI significantly stratified patients Late Recurrence: Randomized
by risk of early and late recurrence controlled trial (Stockholm) and Multi- • 60% of patients have a low risk institutional cohorts (<3%) of late recurrence (Zhang et al. Clin Cancer Res. 2013)  Improved Performance Compared
• BCI significantly stratified patients to Oncotype DX: Head-to-head
by risk of early and late recurrence study in a randomized controlled trial • Oncotype DX could not predict risk of late recurrence (Sgroi et al. Lancet Oncol. 2013)  Prediction of Patient Benefit from
• Patients categorized as High BCI Extended Endocrine Therapy:
(H/I) had a significant benefit from Randomized controlled trial cohort extended therapy (67% reduction in risk of recurrence) (Sgroi et al. J Nat'l Cancer Inst. 2013) • Patients categorized as Low BCI (H/I) did not benefit Clinical impact of BCI in extended endocrine therapy decision-making  Prospective clinical decision-impact study led by Yale University (N=100 pts)  Physicians and Patients completed questionnaires pre- and post-BCI Physician Recommendations for Extended Endocrine Therapy
Treatment
 Individual extended endocrine therapy treatment decisions were changed in approximately 26% of cases  Study demonstrated a net decrease in patients on extended endocrine therapy  Patient anxiety was reduced in 50% of cases Sanft T, et al. Breast Cancer Res Treat. 2015 Actual Data from Clinical Utilization of BCI Confirms Broad Use and large market opportunity T= 0 @ diagnosis Prevalence between years 3-8 years 515k* patients – Each year 167k ER+ early stage breast cancer patients are newly – In addition, approximately 515k patients are already deep in the journey between years 3-8; about 70% of these still persist on endocrine treatments at 5 yrs There are two types of physicians; those that want to use strictly at the anniversary, and others who will also use the test among the prevalent pool of patients The effective market size for BCI ($800M) is a value between these two extremes * Epidemiological estimates are for U.S. only in 2015 Source: Kantar Cancer !Mpact database (2014) BCI is Uniquely Positioned to Inform Extended Endocrine Decision, Similar to Oncotype DX for Chemo Prognostic
Prognostic
(at Diagnosis)
specific)
Predictive of
Predictive of
Extended Endocrine
Therapy Benefit
Breast Cancer
Oncotype DX®
Prosigna™
(Genomic Health)
(Agendia)
Number of Genes
Platform
NanoString nCounter Addresses the Needs of a Broad Group of Metastatic Patients Clear Diagnosis
Diagnosis
Incidence
90 – 130K patients
470 – 510K patients
• CancerTYPE ID is the market • Crowded market leader among gene expression tests • Only 9% penetration because – > 23,000 patient tumors solutions not designed for community analyzed to date – 1,750 physicians ordered test in – Some provide incomplete dynamics
information (e.g., only – Competitively well positioned vs. main players – Others provide too much information at very high cost Source: Mattson-Jack Cancer !Mpact database (2014)
CancerTYPE ID is Supported by Robust Clinical Evidence Clinical
Clinical
Validity
Analytical
Economics
Validity
Outcomes
CancerTYPE ID Pivotal Studies The CancerTYPE ID clinical study program has demonstrated:  Clinical Validity: Blinded, peer-
 87% accuracy adjudicated, clinical study (N=790)  High performance in metastatic led by 3 centers of excellence (UCLA, tumors, high grade tumors, and MGH, Mayo Clinic) limited tissue biopsies (Kerr et al. Clin Cancer Res. 2012;18(14):3952-60)  Clinical Utility: Increase in accuracy
 10% increase in overall accuracy compared to standard of care IHC in compared to IHC (P = 0.019) a study led by the City of Hope Nat'l  CancerTYPE ID accuracy was ≥IHC/Morphology in all tumor (Weiss et al. J Mol Diagn. 2013;15(2):263-9)  Patient Benefit: Prospective clinical
 37% increase trial led by Sarah Canon Research Institute demonstrated increase in overall survival in patients with cancer of unknown primary (Hainsworth et al. J Clin Oncol. 2013;31(2):217-23) Clinical utility of CancerTYPE ID is becoming increasingly clear Results from a 28-site registry study (N = 202)1 Physician-reported clinical utility study (N = 103)2 Identified new cancers not considered Changed treatment decision in about half earlier in 1/4 patients2 Tumor type
considered
Treatment
Tumor type
previously
suspected
Treatment
unchanged
Diagnosis
Kim et al. Personalized Medicine Onc., 2013; 2: 68-76
28-site registry study, Data on file (2014)
Revenue Growth Drivers • Extension of BCI indications • Commercialization ex US • Cell free DNA assays  Commercial stage molecular diagnostics company focused on cancer  We have two high-value proprietary and uniquely differentiated tests on the market, focused on high unmet medical need areas  Medicare coverage of both tests at prices that recognize their value, subject to specific coverage criteria (LCD)  Entering a rapid-growth phase with increasingly diversified growth drivers Medicare Clinical Coverage Criteria – Breast Cancer Index (BCI)
Coverage of the Breast Cancer Index (BCI) is limited to patients that meet the
following criteria:
 Post-menopausal female with non-relapsed, ER+ breast cancer, and
 Was lymph node negative (LN-), and Is completing five (5) years of tamoxifen
 Patient must be eligible for consideration of extended endocrine therapy based on published clinical trial data or practice guidelines, and  Physician or patient is concerned about continuing anti-hormonal therapy because of documented meaningful toxicity or possible significant patient-specific side effects, and  The test results will be discussed with the patient (including the limitations of the testing method, the risks and benefits of either continuing or stopping the therapy based on the test, and current cancer management guidelines). Medicare Clinical Coverage Criteria – CancerTYPE ID CancerTYPE ID is covered as a once-in-a-life time benefit. The assay may be used to resolve an unknown primary tumor or to resolve a pathological diagnosis with 2 or more differential diagnoses. In the unlikely event of a second UPC, denied claims can be appealed through standard Medicare protocol. Use of the CancerTYPE ID assay is limited to:  Tumors for which a single specific site of origin has not been established or resolved by the combination of clinicopathologic studies and consultation with pathologists, radiologists and oncologists.  Specimens, such as cytology cell blocks, where limited quantity of the specimen precludes standard pathologic workups

Source: http://www.biotheranostics.com/files/investors/Investor_Deck_03_2016.pdf

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