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.âs (âthe Companyâ)
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 Companyâs Quarterly Report on Form 10-Q filed with the SEC on May 12,
2017, and the Companyâs Registration Statement on Form S-1 (333-218140, the âregistration statementâ). 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 Companyâs 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 SECâs 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.
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
Drugs&
Diagnos+cs&
Development&
Costs&
Development&
Timelines&
Regulatory&
Risk&
$800M+&
$3M&
8>10&yrs&
1>3&yrs&
FDA&Review&
LDTs&
(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 Diagnosticsâ
Product Portfolio
$300M-
$370M*
Pancreatic Cysts
$1.5B-$2B*
Barrettâs 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
â AETNA Coverage
â UnitedHealth Coverage
â NY State Approval For ThyGenX
â Launched International
Distributions
â EU Patent Granted for ThyraMIR
â LabCorp Co-Promotion
â + 250M Thyroid lives covered
â +71M Pancreas Lives covered
Recent Accomplishments
Corporate
â Revenue Growth 39% Y-O-Y
â Raised over $14M in Equity
â Converted $9M In Secured
Notes into Stock
â Eliminated milestone payments,
liens & royalties related to 2014
RedPath Assets Acquisition
â Reduced Cash Burn $20M Y-O-Y
2015 to 2016
Clinical
â Launched new Biliary product
October 3rd, 2016
â Launched AccuCEA⢠Insights
August 1st, 2016
â Launched PanDNA March, 2017
â Launched BarreGenÂŽ Clinical
Experience Program (CEP)
September 1st, 2016, and Soft
launched BarreGen at select sites
â Launched Cytopathology Services
October 1st, 2016
â Launched Cytology Slides as
primary specimen October1st,
2016
â Launching TERT marker of
aggressiveness June 1st, 2017
â Lab Services Agreement signed
with Einstein Medical Center
June 5th,2017
10. Pancreatic Cancer
Cervical) Ovarian) Prostate) Breast) Pancrea1c) Colorectal) Lung)
4,020
14,270
26,120
40,450
41,780
49,190
158,080
Number of New
US Cases in 2016:
45,000
â The Third Leading U.S. Cancer Killer
https://seer.cancer.gov/statfacts/more.html
Number of US
Deaths in 2016:
41,780
â 5-year survival rate 7.2%
12. Significant Clinical Evidence
1 Al-Haddad MA, Kowalski T, Siddiqui A, Mertz HR, Mallat D, Haddad N, Malhotra N, Sadowski B, Lybik MJ, Patel SN, Okoh E,
Rosenkranz L,Karasik M, Golioto M, Linder J, Catalano MF. Endoscopy. 2015 Feb;47(2):136-46. doi: 10.1055/s-0034-1390742
5 Clinical Validation Papers Published
4 Clinical Utility Papers Published
1 Registry Study published
5 Cost Benefit Studies Published
Budget Impact Model
PancraGEN establishes a new standard for the
prognosis and diagnosis of pancreatic cysts
Sendai guidelines 2012 and ACG guidelines
2007 strongly favor surgical resection because
of the inability of first-line tests to predict
biological behavior and aggressiveness.
16. Clinical Dilemma of Indeterminate
Thyroid Nodules
Finalsurgicalpathologydiagnosis1,2
Non Diagnostic Benign Indeterminate* Malignant
Cytopathology Diagnosis
12%$
6%$
23%$
62%$
97%$
77%$
0%#
20%#
40%#
60%#
80%#
100%#
Suspicious for
Malignancy
*Indeterminate (Follicular Lesion2) includes Atypia of Undetermined Significance (AUS)/Follicular Lesion of Undetermined Significance(FLUS)
and (suspicious for) HĂźrthle/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^
(AfirmaÂŽ)
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
ThyGenX⢠and ThyraMIR⢠combination testing can accurately
âRule inâ and âRule outâ the risk of malignancy
ThyraMIR⢠measures the expression of 10 microRNAs and, and the combination with
ThyGenXâ˘, yields both high NPV and high PPV
Only commercial test that can be performed from FNA and/or Cytology Slides
ThyGenX⢠and ThyraMIR⢠combination testing addresses a unmet clinical need for
more actionable information in the management of indeterminate thyroid nodules
28. 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
- Barrettâs 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