Corporate Presentation

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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

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Biotheranostics History

2010 2011 2012 2013 2004 2006 2008

CTID obtains Medicare

coverage (LCD)

Key BCI clinical studies

published

Key CTID clinical studies

published

CancerTYPE ID (CTID)

biomarker discovery initiated

Commercial launch of

CTID

Breast Cancer Index (BCI) biomarker discovery initiated

AviaraDx acquired by

bioMérieux & renamed

bioTheranostics

CTID & BCI health

economics studies published

Full commercial launch for

BCI

BCI obtains Medicare

Coverage (LCD)

bioT3 released

2014 2016

Commercial ramp for BCI

2015

$32M funding and spinout from bMX

Our Organic Growth Strategy in a Nutshell

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Awareness & Advocacy Sales

Coverage

High Volume Growth

Increased reimbursement ASP

High Revenue Growth

Commercial Decision impact & health

economic studies to support commercial payers contracts

Guidelines Customer experience (lab ops &

client services)

Expanding BCI’s indications (e.g., chemo prediction, neo adjuvant, metastatic)

Cash collection & appeals effectiveness

Levers of Growth

Our Advanced Molecular Tests Target Large Unmet Medical Needs, Cancer Patient Populations and Markets

~ $800M < 3%

~ $300 M < 5%

~ 170k incident patients per year

~ 500k prevalent pool

of patients

~ 100k incident patients per year for all unclear diagnoses

• Early & late recurrence risk • Likelihood of benefit from

endocrine treatments

• Molecular classifier & diagnosis • Biomarkers linked to targeted first

line treatments for metastatic cancer

Epidemiology US Market Size & Penetration

Source: Mattson-Jack Cancer !Mpact database (2014) 5

Patient Journey for Early-Stage, ER+ Breast Cancer

2 – 4 weeks 0 or 3 mo 0- 5/10 years

Treatments Chemo

Radiation

Chronic endocrine treatment (5-10 years)

Diagnosis

Pre-surgical Chemo

Incidence

~170 k/year

Prevalence between years 3-8

~500k

Oncotype DX™

Surgery

Source: Physician interviews, Mattson-Jack Cancer Mpact database (2014)

-

BCI

Epidemiology (for ER+

early-stage patients)

Long-term treatment

+/-

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Challenging Risk vs. Benefit Profile Of Endocrine Drugs Complicates Decision-Making

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ATLAS Trial1 (Tamoxifen for 10y vs 5y) For every 600 women treated,

16 recurrences were prevented At the cost of 2-3…

5 endometrial cancers 2 pulmonary emboli

MA.17 Trial4 (Extended letrozole vs placebo) For every 600 women treated,

+ Long term side effects and QoL impairment2-3

12 recurrences were prevented At the cost of 5-9…

13 new cases osteoporosis 4 bone fractures 1 thromboembolic event

+ Long term side effects and QoL impairment

1. Davies C et al., Lancet. 2013 ;381(9869):805-16. 2. Nolvadex prescribing information. http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088661.pdf. 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. https://www.pharma.us.novartis.com/product/pi/pdf/Femara.pdf 7. Aromasin prescribing information. http://labeling.pfizer.com/ShowLabeling.aspx?id=523 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 2 pulmonary emboli

+ Long term side effects and QoL impairment2-3

13 new cases osteoporosis 4 bone fractures 1 thromboembolic event

+ Long term side effects and QoL impairment

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Sept 2013 Lancet Oncology Editorial

There is only one validated predictive test available today:

“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.”

Addressing a Key Unmet Medical Need

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BCI Predictive Predicts Likelihood of Benefit

From Hormonal Therapy

BCI Prognostic Assesses Individual Risk of Recurrence from 0-10 years

Initial focus is on the area of greatest unmet need:

Late recurrence risk (5-10 yrs) Benefit from extended endocrine therapy (5-10 yrs)

Second Generation Molecular Diagnostic Test With Two Components

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• Consider completion of endocrine Rx at 5 years • For patients already on extended endocrine Rx, consider stopping ~45%

Low Risk/Low 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

~30%

High Risk/High Likelihood of Benefit

• Consider additional and other therapeutic approaches for risk reduction and more frequent monitoring ~15%

High Risk/Low Likelihood of Benefit

• Consider continuation of endocrine Rx beyond year 5 if patient is tolerating well and has no concerning comorbidities

~10%

Low Risk/High Likelihood of Benefit

Clinically Actionable Information that can impact her treatment plan

Notes: % 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

• Individualized risk of late recurrence

• High / Low Risk

• Predictive of likelihood of benefit from extended endocrine therapy

• High or Low (binary result)

RT-PCR Extract RNA

Patient Tissue Sample (FFPE)

Tumor dissection

BCI Prognostic

BCI Predictive (H/I ratio) (1) Biomarker: HoxB13/IL17BR (H/I) gene expression ratio

(2) Biomarker: Molecular Grade Index (MGI)1, which includes 5 cell cycle genes (BUB1B, CENPA, NEK2, RACGAP1, RRM2)

• Algorithm evaluates patient’s gene expression profile

• Interrogates estrogen signaling(1) and proliferative(2) pathways

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BCI Sample Test Report

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Breast Cancer Index Supported by Robust Clinical Evidence

Clinical Utility

Clinical Validity

Analytical Validity

Health Economics

& Outcomes

Technical robustness of biomarker

Pivotal studies (2013) Integration into clinical practice

Health and cost effectiveness

CCR

JNCI

Lancet Oncology

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BCI Pivotal Studies

The BCI clinical study program has demonstrated: • BCI significantly stratified patients

by risk of early and late recurrence • ~60% of patients have a low risk

(<3%) of late recurrence

• BCI significantly stratified patients by risk of early and late recurrence

• Oncotype DX could not predict risk of late recurrence

• Patients categorized as High BCI (H/I) had a significant benefit from extended therapy (67% reduction in risk of recurrence)

• Patients categorized as Low BCI (H/I) did not benefit

Risk Assessment for Early and Late Recurrence: Randomized controlled trial (Stockholm) and Multi-institutional cohorts

(Zhang et al. Clin Cancer Res. 2013)

Improved Performance Compared to Oncotype DX: Head-to-head study in a randomized controlled trial cohort (ATAC)

(Sgroi et al. Lancet Oncol. 2013)

Prediction of Patient Benefit from Extended Endocrine Therapy: Randomized controlled trial cohort (MA.17)

(Sgroi et al. J Nat’l Cancer Inst. 2013)

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Clinical impact of BCI in extended endocrine therapy decision-making

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

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Prospective clinical decision-impact study led by Yale University (N=100 pts) Physicians and Patients completed questionnaires pre- and post-BCI

Treatment Changed

27%

Physician Recommendations for Extended Endocrine Therapy

Sanft T, et al. Breast Cancer Res Treat. 2015

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Actual Data from Clinical Utilization of BCI Confirms Broad Use and large market opportunity

Epidemiology: – Each year ~167k ER+ early stage breast cancer patients are newly

diagnosed – 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

Prevalence between years 3-8 years ~ 515k* patients

T= 5 yrs T= 0 @ diagnosis T= 10 yrs

Incidence ~ 167k*

* Epidemiological estimates are for U.S. only in 2015 Source: Kantar Cancer !Mpact database (2014)

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BCI is Uniquely Positioned to Inform Extended Endocrine Decision, Similar to Oncotype DX for Chemo

Diagnosis 5 yrs 10 yrs

Predictive of Chemotherapy

Benefit

Prognostic (at Diagnosis)

Prognostic (Late Recurrence-

specific)

Predictive of Extended Endocrine

Therapy Benefit

Oncotype DX®

(Genomic Health) MammaPrint®

(Agendia) Prosigna™

(Nanostring)

Breast Cancer IndexSM

(Biotheranostics)

Number of Genes 21 70 50 11

Platform RT-PCR Microarray NanoString nCounter RT-PCR

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CUP Wide differential Differential Confirmatory Certain

Diagnosis

Clear Diagnosis

Incidence

Market dynamics

90 – 130K patients 470 – 510K patients

• CancerTYPE ID is the market leader among gene expression tests

– > 23,000 patient tumors analyzed to date

– 1,750 physicians ordered test in last 12 months

– Competitively well positioned vs. main players

• Crowded market • Only ~9% penetration because

solutions not designed for community practices needs

– Some provide incomplete information (e.g., only sequencing)

– Others provide too much information at very high cost

No Yes ~15% ~85%

Source: Mattson-Jack Cancer !Mpact database (2014)

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Addresses the Needs of a Broad Group of Metastatic Patients

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CancerTYPE ID is Supported by Robust Clinical Evidence

Clinical Utility

Clinical Validity

Analytical Validity

Health Economics

& Outcomes

CancerTYPE ID Pivotal Studies

The CancerTYPE ID clinical study program has demonstrated:

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87% accuracy High performance in metastatic

tumors, high grade tumors, and limited tissue biopsies

10% increase in overall accuracy compared to IHC (P = 0.019)

CancerTYPE ID accuracy was ≥IHC/Morphology in all tumor types examined

37% increase in overall survival

Clinical Validity: Blinded, peer-adjudicated, clinical study (N=790) led by 3 centers of excellence (UCLA, MGH, Mayo Clinic)

(Kerr et al. Clin Cancer Res. 2012;18(14):3952-60)

Clinical Utility: Increase in accuracy compared to standard of care IHC in a study led by the City of Hope Nat’l Medical Center

(Weiss et al. J Mol Diagn. 2013;15(2):263-9)

Patient Benefit: Prospective clinical 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

22 Kim et al. Personalized Medicine Onc., 2013; 2: 68-76 28-site registry study, Data on file (2014)

Tumor type suspected

or in differential Diagnosis 72%

Tumor type not

considered previously 28%

Identified new cancers not considered earlier in ~1/4 patients2

Treatment changed 46% Treatment

unchanged 54%

Changed treatment decision in about half the cases1

Basis: • Results from a 28-site registry study (N = 202)1 • Physician-reported clinical utility study (N = 103)2

Revenue Growth Drivers

2010 - 2013 2014 2015 - 2016 2017 +

+ • Extension of BCI indications • Commercialization ex US

• Cell free DNA assays +

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Summary

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

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Back-up slides

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

therapy, and 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