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Interpace
Diagnostics
PRESENTATION SEPTEMBER 2017
IDXG
Forward Looking Statements
This Investor Presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the
Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to Interpace Diagnostic Group Inc.ā€™s (ā€œthe Companyā€)
future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including "believes,"
"estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words
that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations,
assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business
decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve
known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or
implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the Company's ability
to adequately finance the business, its ability to restructure its liabilities and other obligations, the market's acceptance of its molecular diagnostic tests, its
ability to retain or secure reimbursement, its ability to secure additional business and generate higher profit margins through sales of its molecular
diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments and
our ability to maintain our NASDAQ listing. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the
Company's filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on
March 31, 2017 and the amendment on Form 10-K/A filed on April 28, 2017, the Companyā€™s Quarterly Report on Form 10-Q filed with the SEC on May 12,
2017, and the Companyā€™s Registration Statement on Form S-1 (333-218140, the ā€œregistration statementā€). Because of these and other risks, uncertainties
and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of
hereof and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any
reason. The Company has filed the Registration Statement (including a preliminary prospectus) with the Securities and Exchange Commission (SEC) for the
offering for which this Investor Presentation relates. Before you invest, you should read the preliminary prospectus contained in the Companyā€™s Registration
Statement and other documents the Company has filed with the SEC for more complete information about the Company and this offering. The preliminary
prospectus and the Registration Statement may be accessed through the SECā€™s website at www.sec.gov. Alternatively, the Company, any underwriter or
any dealer participating in the offering will arrange to send you the preliminary prospectus if you request it through Maxim Group LLC, 405 Lexington Ave,
New York, NY 10174, Attn: Prospectus Department or by Tel: (800) 724-0761. This Investor Presentation contains statistics and other data that has been
obtained from or compiled from information made available by third parties service providers. The Company has not independently verified such statistics
or data. The information presented in this Investor Presentation is as of June 5, 2017 unless indicated otherwise.
We are a fully integrated ā€œcommercialā€ company
that provides molecular and diagnostic tests and
pathology services to evaluate the risk of cancer by
leveraging the latest technology in personalized
medicine for better informed clinical decisions and
improved patient management.
Our Mission
Inconclusive Biopsy: Uncertainty
Drives Need for Molecular Testing
Indeterminate
Results
Diagnostic
Biopsy
Unnecessary
Surgeries
Wrong
Treatment
Delayed
Treatment
Molecular Diagnostics improve patient
outcomes and result in significant cost
savings to the healthcare system
Molecular
Diagnostics
Improved
Outcomes
Significant
Cost Savings
Appropriate
Surgery
Non-Surgical
Follow up
The right treatment for the patient
at the right time
Investment Highlights
NASDAQ Listed
Liquid Stock
Internal
Reimbursement
Capabilities
Dedicated Sales
Organization of
24
Raised $14M
Since End Dec
2016
Medicare and
Private
Insurance
coverage
39% YoY
(2015 vs. 2016)
Revenue
Growth
Long-term Debt
Free
3 Products In
The Market
Attractive Molecular
Business Model
Versus Drugs, Diagnostics have:
- Lower Developmental Costs
- Lower Developmental Risk
- Faster time to market
- Lower regulatory hurdles
2014 American Thyroid Association Revised Guidelines
Molecular Diagnostics tests should be considered for
suspicion of malignancy or indeterminate.
2013 NCCN Guidelines
Molecular Diagnostics recommended testing on some
indeterminate cytologies to minimize unnecessary surgeries
2016 ASGE Guidelines
Recommendation no. 4 suggests use of PancraGen should be
considered when cysts are indeterminate based on cytology
Current Pancreatic Cysts Guidelines
Sendai guidelines 2012 and ACG guidelines 2007 strongly
favor surgical resection because of the inability of first-line
tests to predict biological behavior and aggressiveness.
De-Risked Business Model Strong Guideline Support
(including
FDA review)
Risk-Stratifies
Pancreatic Cysts
Over 71M
Lives Covered
Integrated
Molecular
Pathology test
Risk-Stratifies
Barrett's
Esophagus
Soft Launch
Began In 2017
Integrated
Molecular
Pathology test
NGS panel for
Thyroid Cancer
Over 250M
Lives Covered
Rules In Thyroid
Cancer
Micro-RNA
Classifier
Over 250M
Lives Covered
Rules Out
Thyroid Cancer
Interpace Diagnosticsā€™
Product Portfolio
$300M-
$370M*
Pancreatic Cysts
$1.5B-$2B*
Barrettā€™s Esophagus
$350M*
Thyroid Nodules
$350M*
Thyroid Nodules
* Total Market opportunity, Company Estimates, www.endocrineweb.com, C. Hur et al. Gastroenterology, (May 21, 2012).
Commercial
ā—‰ AETNA Coverage
ā—‰ UnitedHealth Coverage
ā—‰ NY State Approval For ThyGenX
ā—‰ Launched International
Distributions
ā—‰ EU Patent Granted for ThyraMIR
ā—‰ LabCorp Co-Promotion
ā—‰ + 250M Thyroid lives covered
ā—‰ +71M Pancreas Lives covered
Recent Accomplishments
Corporate
ā—‰ Revenue Growth 39% Y-O-Y
ā—‰ Raised over $14M in Equity
ā—‰ Converted $9M In Secured
Notes into Stock
ā—‰ Eliminated milestone payments,
liens & royalties related to 2014
RedPath Assets Acquisition
ā—‰ Reduced Cash Burn $20M Y-O-Y
2015 to 2016
Clinical
ā—‰ Launched new Biliary product
October 3rd, 2016
ā—‰ Launched AccuCEAā„¢ Insights
August 1st, 2016
ā—‰ Launched PanDNA March, 2017
ā—‰ Launched BarreGenĀ® Clinical
Experience Program (CEP)
September 1st, 2016, and Soft
launched BarreGen at select sites
ā—‰ Launched Cytopathology Services
October 1st, 2016
ā—‰ Launched Cytology Slides as
primary specimen October1st,
2016
ā—‰ Launching TERT marker of
aggressiveness June 1st, 2017
ā—‰ Lab Services Agreement signed
with Einstein Medical Center
June 5th,2017
PANCREATIC CYSTS CANCER RISK
POWERED BY PathFinderTGĀ®
Pancreatic Cancer
4,020
14,270
26,120
40,450
41,780
49,190
158,080
Number of New
US Cases in 2016:
45,000
ā—‰ The Third Leading U.S. Cancer Killer
https://seer.cancer.gov/statfacts/more.html
Number of US
Deaths in 2016:
41,780
ā—‰ 5-year survival rate 7.2%
PancraGEN
Integrated Molecular Pathology
Imaging Cytology
Fluid
Analysis
Molecular
Diagnostics
Pathologist
Review
PancraGen
% [95% CI]
Sendai 2012 model
% [95%CI]
P value for PancraGen
vs. Sendai 2012 model
NPV 97.2 [95.1-98.6] 97 [93.7-98.9] 0.88
PPV 57.9 [47.3-68.0] 20.8 [16.2-25.9] <0.0001
Results published in leading GI journal, Endoscopy
PancraGEN can identify non-progressors as well as 2012 International
Sendai Guidelines, however itā€™s significantly better at identifying
progressors
Eluri et al. Am J Gastroenterol 2015; 110:828ā€“834; doi: 10.1038/ajg.2015.152 (9)
Significant Clinical Evidence
1 Al-Haddad MA, Kowalski T, Siddiqui A, Mertz HR, Mallat D, Haddad N, Malhotra N, Sadowski B, Lybik MJ, Patel SN, Okoh E,
Rosenkranz L,Karasik M, Golioto M, Linder J, Catalano MF. Endoscopy. 2015 Feb;47(2):136-46. doi: 10.1055/s-0034-1390742
5 Clinical Validation Papers Published
4 Clinical Utility Papers Published
1 Registry Study published
5 Cost Benefit Studies Published
Budget Impact Model
PancraGEN establishes a new standard for the
prognosis and diagnosis of pancreatic cysts
Sendai guidelines 2012 and ACG guidelines
2007 strongly favor surgical resection because
of the inability of first-line tests to predict
biological behavior and aggressiveness.
PancraGEN Adoption &
Growth
ļƒ¼ 250 Physicians and Hospitals
ļƒ¼ Over 30,000 tests performed
ļƒ¼ International Distribution
Medicare
ENDOCRINE ONCOLOGY
Thyroid Nodules
^American Cancer Society http://www.cancernetwork.com/thyroid-cancer/thyroid-nodules-when-biopsy^
* https://seer.cancer.gov/statfacts/html/thyro.html
56,870 estimated new cases of thyroid
cancer in 2017.*
Prevalence of This Cancer: In 2014, there were an
estimated 726,646 people living with thyroid
cancer in the United States.*
Thyroid Cancer Incidence*
ā—‰ ~10-18M U.S. adults have Nodules^
ā—‰ Estimated 525,00 thyroid Fine Needle
Aspirates (FNAs) per year in the U.S. and
growing
Clinical Dilemma of Indeterminate
Thyroid Nodules
Finalsurgicalpathologydiagnosis1,2
Non Diagnostic Benign Indeterminate* Malignant
Cytopathology Diagnosis
Suspicious for
Malignancy
*Indeterminate (Follicular Lesion2) includes Atypia of Undetermined Significance (AUS)/Follicular Lesion of Undetermined Significance(FLUS)
and (suspicious for) HĆ¼rthle/Follicular Neoplasm
1 Gharib H, et al. Endoc Pract 2010.
2 Wang CC, et al. Thyroid 2011.
Molecular Testing Value:
Prevent Unnecessary
Surgeries
Data Comparison
with Market Leader
Test performance
[95% CI]
Combined mutation &
miRNA testing
(ThyGenX + ThyraMIR)*
Mutation testing
alone
(ThyGenX)*
Gene expression classifier with
mRNA testing^
(AfirmaĀ®)
PPV (%) 74% [58-86] 81% [54-96] 47% [40-55] 37% [23-52]
NPV (%) 94 %[85-98] 64 %[47-79] 93% [86-97] 94% [79-99]
*Labourier et al. JCEM 2015.
^Alexander et al. NJEM 2012
ThyGenXā„¢ and ThyraMIRā„¢ combination testing can accurately
ā€œRule inā€ and ā€œRule outā€ the risk of malignancy
ThyraMIRā„¢ measures the expression of 10 microRNAs and, and the combination with
ThyGenXā„¢, yields both high NPV and high PPV
Only commercial test that can be performed from FNA and/or Cytology Slides
ThyGenXā„¢ and ThyraMIRā„¢ combination testing addresses a unmet clinical need for
more actionable information in the management of indeterminate thyroid nodules
Multiple Publications Support Clinical Validity
and Utility of ThyGenX / ThyraMIR
ThyGenX / ThyraMIR Strong
Adoption & Growth
ļƒ¼ 400 Physicians and Hospitals
ļƒ¼ Over 15,000 tests performed
ļƒ¼ LabCorp Partnership
ļƒ¼ International Distribution
Medicare
BARRETTā€™S ESOPHAGUS RISK OF
PROGRESSION TO CANCER
POWERED BY PathFinderTGĀ®
What is Barrettā€™s Esophagus?
ā—‰ Gastroesophageal reflux very common (10-20% US adults)
ā—‰ 6% progress to Barrett's Esophagus (~3.3 million adults)
ā—‰ Barrett's Esophagus precedes esophageal cancer (EAC)
infrequently (1-3%)
ā—‰ Ablation (Barrx) has emerged as a treatment and prevention
strategy
ā—‰ Current tests cannot predict which patients will progress to
Esophageal Cancer ā€“ one of the most lethal cancers ā€“
creating a high unmet need for a molecular diagnostic test
BarreGEN for
Barrettā€™s Esophagus
$1.5-$2B
Potential
~3.3M
Adults
~850,000
Endoscopic screens Annually
Source: Indications and Outcomes of Gastrointestinal Endoscopy, 2009
Same PathfinderTGĀ® platform
BarreGEN Clinical Experience Program (CEP) launched September 1st, 2016
How May BarreGEN Be
Useful?
BarreGEN can allow for more personalized management of Barrettā€™s patients
Aid In
strategies to
prevent cancer
by ablation
Avoid
unnecessary &
expensive
($30K)
recurring
ablation
Help monitor
patients
during
surveillance
Reduce overall
cost of care
Multiple Publications Support Clinical
Validity and Utility of BarreGEN
FINANCIAL AND CORPORATE
REVIEW
Select Financial Information
Income Statement 2016 2015 Q2 2017 Q2 2016
Revenue $13.1 $9.4 $3.9 $3.6
Gross Profit $6.4 $2.5 $2.0 $1.8
Total Operating Expenses $12.9 $42.9 $5.6 $4.7
Loss from Continuing Ops ($8.4) ($31.1) $(6.3) ($3.5)
Balance Sheet
Cash Balance (End of Period) $0.6 $8.3 $14.3 $3.0
Accounts Payable and Accrued
Expenses
$12.1 $9.9 $8.5 $10.2
Stockholdersā€™ Equity $6.5 $13.0 $36.3 $6.0
(In US Million)
Source: SEC Filings, 10-K
Patent Portfolio and
Proprietary Attributes
Thyroid 2 US patents pending, 5 ex-US Patents Pending
Pancreas
Barrettā€™s Esophagus
Proprietary
Extensive experience in managing extremely low quality, fixative treated clinical specimens.
Lab information management system that extracts results from database and allows efficient
integration of molecular and clinical results.
Proprietary Algorithm for ThyraMIR Classifier.
Proprietary extraction and micro dissection, methodology from slides, Buffer and FFPE
samples.
5 patents Issued
2 patents Pending
2017/18
Key Drivers of Growth
Internal Drivers
Contract with Aetna & United
Healthcare (Thyroid)
Expanding Sales Force
Launch V2 of ThyGenX
Launch TERT Marker of
Aggressiveness
New PancraGEN studies (GI)
Additional Lab Services Contracts
External Drivers
Selective M&A Activities
Strategic Partnership For BarreGEN
Renewal of LabCorp Contract
Experienced Management Team
Jack Stover
President, CEO
Greg Richard
Sr. VP. Commercial Services
Syd Finklestein, MD
Chief Scientific Officer
Jim Early
VP CFO
Glenn Gershon
Sr. VP. Operations
Alidad Mireskandari, Ph.D.
VP Business Development
Why Invest in IDXG?
We offer a unique profile
Significant Financial
Progress
- Strong, growing revenue (39% YoY
2015 to 2016) and reimbursement
- NASDAQ listed
- Eliminated all of our secured debt and
liens and eliminated royalty &
milestone obligations from 2014
purchase of RedPath Assets
- Demonstrated liquidity with our stock
trading volume
- $14M cash raised in last 6 months
- ThyGenX V2 development underway
- Thyroid registry launched
- Multi-Center Thyroid study launched
- Barrettā€™s CEP/Soft launch underway
- Multiple presentations at key
Scientific meetings planned for 2017
- PancraGEN: 3 clinical utility studies
underway
Expansion of Clinical
Research
- 24 Person Internal Sales
Organization
- In-house billing, reimbursement and
collections expertise
- Marketing and product launch
expertise
- AETNA & United Health approvals
- All products covered by Medicare
- 250+ million lives covered for Thyroid
test
- 71+ million lives covered for
PancraGEN test
Growing Commercial
Capabilities
A SIGNIFICANT BD OPPORTUNITY AND LARGE MARKET OPPORTUNITY IN BARREGEN
Thank You

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IDXG Investor Presentation

  • 2. Forward Looking Statements This Investor Presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to Interpace Diagnostic Group Inc.ā€™s (ā€œthe Companyā€) future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the Company's ability to adequately finance the business, its ability to restructure its liabilities and other obligations, the market's acceptance of its molecular diagnostic tests, its ability to retain or secure reimbursement, its ability to secure additional business and generate higher profit margins through sales of its molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments and our ability to maintain our NASDAQ listing. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 31, 2017 and the amendment on Form 10-K/A filed on April 28, 2017, the Companyā€™s Quarterly Report on Form 10-Q filed with the SEC on May 12, 2017, and the Companyā€™s Registration Statement on Form S-1 (333-218140, the ā€œregistration statementā€). Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of hereof and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason. The Company has filed the Registration Statement (including a preliminary prospectus) with the Securities and Exchange Commission (SEC) for the offering for which this Investor Presentation relates. Before you invest, you should read the preliminary prospectus contained in the Companyā€™s Registration Statement and other documents the Company has filed with the SEC for more complete information about the Company and this offering. The preliminary prospectus and the Registration Statement may be accessed through the SECā€™s website at www.sec.gov. Alternatively, the Company, any underwriter or any dealer participating in the offering will arrange to send you the preliminary prospectus if you request it through Maxim Group LLC, 405 Lexington Ave, New York, NY 10174, Attn: Prospectus Department or by Tel: (800) 724-0761. This Investor Presentation contains statistics and other data that has been obtained from or compiled from information made available by third parties service providers. The Company has not independently verified such statistics or data. The information presented in this Investor Presentation is as of June 5, 2017 unless indicated otherwise.
  • 3. We are a fully integrated ā€œcommercialā€ company that provides molecular and diagnostic tests and pathology services to evaluate the risk of cancer by leveraging the latest technology in personalized medicine for better informed clinical decisions and improved patient management. Our Mission
  • 4. Inconclusive Biopsy: Uncertainty Drives Need for Molecular Testing Indeterminate Results Diagnostic Biopsy Unnecessary Surgeries Wrong Treatment Delayed Treatment Molecular Diagnostics improve patient outcomes and result in significant cost savings to the healthcare system Molecular Diagnostics Improved Outcomes Significant Cost Savings Appropriate Surgery Non-Surgical Follow up The right treatment for the patient at the right time
  • 5. Investment Highlights NASDAQ Listed Liquid Stock Internal Reimbursement Capabilities Dedicated Sales Organization of 24 Raised $14M Since End Dec 2016 Medicare and Private Insurance coverage 39% YoY (2015 vs. 2016) Revenue Growth Long-term Debt Free 3 Products In The Market
  • 6. Attractive Molecular Business Model Versus Drugs, Diagnostics have: - Lower Developmental Costs - Lower Developmental Risk - Faster time to market - Lower regulatory hurdles 2014 American Thyroid Association Revised Guidelines Molecular Diagnostics tests should be considered for suspicion of malignancy or indeterminate. 2013 NCCN Guidelines Molecular Diagnostics recommended testing on some indeterminate cytologies to minimize unnecessary surgeries 2016 ASGE Guidelines Recommendation no. 4 suggests use of PancraGen should be considered when cysts are indeterminate based on cytology Current Pancreatic Cysts Guidelines Sendai guidelines 2012 and ACG guidelines 2007 strongly favor surgical resection because of the inability of first-line tests to predict biological behavior and aggressiveness. De-Risked Business Model Strong Guideline Support (including FDA review)
  • 7. Risk-Stratifies Pancreatic Cysts Over 71M Lives Covered Integrated Molecular Pathology test Risk-Stratifies Barrett's Esophagus Soft Launch Began In 2017 Integrated Molecular Pathology test NGS panel for Thyroid Cancer Over 250M Lives Covered Rules In Thyroid Cancer Micro-RNA Classifier Over 250M Lives Covered Rules Out Thyroid Cancer Interpace Diagnosticsā€™ Product Portfolio $300M- $370M* Pancreatic Cysts $1.5B-$2B* Barrettā€™s Esophagus $350M* Thyroid Nodules $350M* Thyroid Nodules * Total Market opportunity, Company Estimates, www.endocrineweb.com, C. Hur et al. Gastroenterology, (May 21, 2012).
  • 8. Commercial ā—‰ AETNA Coverage ā—‰ UnitedHealth Coverage ā—‰ NY State Approval For ThyGenX ā—‰ Launched International Distributions ā—‰ EU Patent Granted for ThyraMIR ā—‰ LabCorp Co-Promotion ā—‰ + 250M Thyroid lives covered ā—‰ +71M Pancreas Lives covered Recent Accomplishments Corporate ā—‰ Revenue Growth 39% Y-O-Y ā—‰ Raised over $14M in Equity ā—‰ Converted $9M In Secured Notes into Stock ā—‰ Eliminated milestone payments, liens & royalties related to 2014 RedPath Assets Acquisition ā—‰ Reduced Cash Burn $20M Y-O-Y 2015 to 2016 Clinical ā—‰ Launched new Biliary product October 3rd, 2016 ā—‰ Launched AccuCEAā„¢ Insights August 1st, 2016 ā—‰ Launched PanDNA March, 2017 ā—‰ Launched BarreGenĀ® Clinical Experience Program (CEP) September 1st, 2016, and Soft launched BarreGen at select sites ā—‰ Launched Cytopathology Services October 1st, 2016 ā—‰ Launched Cytology Slides as primary specimen October1st, 2016 ā—‰ Launching TERT marker of aggressiveness June 1st, 2017 ā—‰ Lab Services Agreement signed with Einstein Medical Center June 5th,2017
  • 9. PANCREATIC CYSTS CANCER RISK POWERED BY PathFinderTGĀ®
  • 10. Pancreatic Cancer 4,020 14,270 26,120 40,450 41,780 49,190 158,080 Number of New US Cases in 2016: 45,000 ā—‰ The Third Leading U.S. Cancer Killer https://seer.cancer.gov/statfacts/more.html Number of US Deaths in 2016: 41,780 ā—‰ 5-year survival rate 7.2%
  • 11. PancraGEN Integrated Molecular Pathology Imaging Cytology Fluid Analysis Molecular Diagnostics Pathologist Review PancraGen % [95% CI] Sendai 2012 model % [95%CI] P value for PancraGen vs. Sendai 2012 model NPV 97.2 [95.1-98.6] 97 [93.7-98.9] 0.88 PPV 57.9 [47.3-68.0] 20.8 [16.2-25.9] <0.0001 Results published in leading GI journal, Endoscopy PancraGEN can identify non-progressors as well as 2012 International Sendai Guidelines, however itā€™s significantly better at identifying progressors Eluri et al. Am J Gastroenterol 2015; 110:828ā€“834; doi: 10.1038/ajg.2015.152 (9)
  • 12. Significant Clinical Evidence 1 Al-Haddad MA, Kowalski T, Siddiqui A, Mertz HR, Mallat D, Haddad N, Malhotra N, Sadowski B, Lybik MJ, Patel SN, Okoh E, Rosenkranz L,Karasik M, Golioto M, Linder J, Catalano MF. Endoscopy. 2015 Feb;47(2):136-46. doi: 10.1055/s-0034-1390742 5 Clinical Validation Papers Published 4 Clinical Utility Papers Published 1 Registry Study published 5 Cost Benefit Studies Published Budget Impact Model PancraGEN establishes a new standard for the prognosis and diagnosis of pancreatic cysts Sendai guidelines 2012 and ACG guidelines 2007 strongly favor surgical resection because of the inability of first-line tests to predict biological behavior and aggressiveness.
  • 13. PancraGEN Adoption & Growth ļƒ¼ 250 Physicians and Hospitals ļƒ¼ Over 30,000 tests performed ļƒ¼ International Distribution Medicare
  • 15. Thyroid Nodules ^American Cancer Society http://www.cancernetwork.com/thyroid-cancer/thyroid-nodules-when-biopsy^ * https://seer.cancer.gov/statfacts/html/thyro.html 56,870 estimated new cases of thyroid cancer in 2017.* Prevalence of This Cancer: In 2014, there were an estimated 726,646 people living with thyroid cancer in the United States.* Thyroid Cancer Incidence* ā—‰ ~10-18M U.S. adults have Nodules^ ā—‰ Estimated 525,00 thyroid Fine Needle Aspirates (FNAs) per year in the U.S. and growing
  • 16. Clinical Dilemma of Indeterminate Thyroid Nodules Finalsurgicalpathologydiagnosis1,2 Non Diagnostic Benign Indeterminate* Malignant Cytopathology Diagnosis Suspicious for Malignancy *Indeterminate (Follicular Lesion2) includes Atypia of Undetermined Significance (AUS)/Follicular Lesion of Undetermined Significance(FLUS) and (suspicious for) HĆ¼rthle/Follicular Neoplasm 1 Gharib H, et al. Endoc Pract 2010. 2 Wang CC, et al. Thyroid 2011. Molecular Testing Value: Prevent Unnecessary Surgeries
  • 17. Data Comparison with Market Leader Test performance [95% CI] Combined mutation & miRNA testing (ThyGenX + ThyraMIR)* Mutation testing alone (ThyGenX)* Gene expression classifier with mRNA testing^ (AfirmaĀ®) PPV (%) 74% [58-86] 81% [54-96] 47% [40-55] 37% [23-52] NPV (%) 94 %[85-98] 64 %[47-79] 93% [86-97] 94% [79-99] *Labourier et al. JCEM 2015. ^Alexander et al. NJEM 2012 ThyGenXā„¢ and ThyraMIRā„¢ combination testing can accurately ā€œRule inā€ and ā€œRule outā€ the risk of malignancy ThyraMIRā„¢ measures the expression of 10 microRNAs and, and the combination with ThyGenXā„¢, yields both high NPV and high PPV Only commercial test that can be performed from FNA and/or Cytology Slides ThyGenXā„¢ and ThyraMIRā„¢ combination testing addresses a unmet clinical need for more actionable information in the management of indeterminate thyroid nodules
  • 18. Multiple Publications Support Clinical Validity and Utility of ThyGenX / ThyraMIR
  • 19. ThyGenX / ThyraMIR Strong Adoption & Growth ļƒ¼ 400 Physicians and Hospitals ļƒ¼ Over 15,000 tests performed ļƒ¼ LabCorp Partnership ļƒ¼ International Distribution Medicare
  • 20. BARRETTā€™S ESOPHAGUS RISK OF PROGRESSION TO CANCER POWERED BY PathFinderTGĀ®
  • 21. What is Barrettā€™s Esophagus? ā—‰ Gastroesophageal reflux very common (10-20% US adults) ā—‰ 6% progress to Barrett's Esophagus (~3.3 million adults) ā—‰ Barrett's Esophagus precedes esophageal cancer (EAC) infrequently (1-3%) ā—‰ Ablation (Barrx) has emerged as a treatment and prevention strategy ā—‰ Current tests cannot predict which patients will progress to Esophageal Cancer ā€“ one of the most lethal cancers ā€“ creating a high unmet need for a molecular diagnostic test
  • 22. BarreGEN for Barrettā€™s Esophagus $1.5-$2B Potential ~3.3M Adults ~850,000 Endoscopic screens Annually Source: Indications and Outcomes of Gastrointestinal Endoscopy, 2009 Same PathfinderTGĀ® platform BarreGEN Clinical Experience Program (CEP) launched September 1st, 2016
  • 23. How May BarreGEN Be Useful? BarreGEN can allow for more personalized management of Barrettā€™s patients Aid In strategies to prevent cancer by ablation Avoid unnecessary & expensive ($30K) recurring ablation Help monitor patients during surveillance Reduce overall cost of care
  • 24. Multiple Publications Support Clinical Validity and Utility of BarreGEN
  • 26. Select Financial Information Income Statement 2016 2015 Q2 2017 Q2 2016 Revenue $13.1 $9.4 $3.9 $3.6 Gross Profit $6.4 $2.5 $2.0 $1.8 Total Operating Expenses $12.9 $42.9 $5.6 $4.7 Loss from Continuing Ops ($8.4) ($31.1) $(6.3) ($3.5) Balance Sheet Cash Balance (End of Period) $0.6 $8.3 $14.3 $3.0 Accounts Payable and Accrued Expenses $12.1 $9.9 $8.5 $10.2 Stockholdersā€™ Equity $6.5 $13.0 $36.3 $6.0 (In US Million) Source: SEC Filings, 10-K
  • 27. Patent Portfolio and Proprietary Attributes Thyroid 2 US patents pending, 5 ex-US Patents Pending Pancreas Barrettā€™s Esophagus Proprietary Extensive experience in managing extremely low quality, fixative treated clinical specimens. Lab information management system that extracts results from database and allows efficient integration of molecular and clinical results. Proprietary Algorithm for ThyraMIR Classifier. Proprietary extraction and micro dissection, methodology from slides, Buffer and FFPE samples. 5 patents Issued 2 patents Pending
  • 28. 2017/18 Key Drivers of Growth Internal Drivers Contract with Aetna & United Healthcare (Thyroid) Expanding Sales Force Launch V2 of ThyGenX Launch TERT Marker of Aggressiveness New PancraGEN studies (GI) Additional Lab Services Contracts External Drivers Selective M&A Activities Strategic Partnership For BarreGEN Renewal of LabCorp Contract
  • 29. Experienced Management Team Jack Stover President, CEO Greg Richard Sr. VP. Commercial Services Syd Finklestein, MD Chief Scientific Officer Jim Early VP CFO Glenn Gershon Sr. VP. Operations Alidad Mireskandari, Ph.D. VP Business Development
  • 30. Why Invest in IDXG? We offer a unique profile Significant Financial Progress - Strong, growing revenue (39% YoY 2015 to 2016) and reimbursement - NASDAQ listed - Eliminated all of our secured debt and liens and eliminated royalty & milestone obligations from 2014 purchase of RedPath Assets - Demonstrated liquidity with our stock trading volume - $14M cash raised in last 6 months - ThyGenX V2 development underway - Thyroid registry launched - Multi-Center Thyroid study launched - Barrettā€™s CEP/Soft launch underway - Multiple presentations at key Scientific meetings planned for 2017 - PancraGEN: 3 clinical utility studies underway Expansion of Clinical Research - 24 Person Internal Sales Organization - In-house billing, reimbursement and collections expertise - Marketing and product launch expertise - AETNA & United Health approvals - All products covered by Medicare - 250+ million lives covered for Thyroid test - 71+ million lives covered for PancraGEN test Growing Commercial Capabilities A SIGNIFICANT BD OPPORTUNITY AND LARGE MARKET OPPORTUNITY IN BARREGEN