- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
Exact Sciences chairman and CEO Kevin Conroy delivered the company's presentation at the 2015 Baird 2015 Healthcare Conference in New York at 9:40 a.m. ET on Wednesday, Sept. 9.
An archive of the webcast is available here: http://wsw.com/webcast/baird43/register.aspx?conf=baird43&page=exas&url=http://wsw.com/webcast/baird43/exas/index.aspx
Exact Sciences chairman and CEO Kevin Conroy delivered the company's presentation at the 2015 Baird 2015 Healthcare Conference in New York at 9:40 a.m. ET on Wednesday, Sept. 9.
An archive of the webcast is available here: http://wsw.com/webcast/baird43/register.aspx?conf=baird43&page=exas&url=http://wsw.com/webcast/baird43/exas/index.aspx
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Exact Sciences Company Presentation Baird Healthcare ConferenceExact Sciences
Exact Sciences CEO Kevin Conroy's presentation slides, featuring updates on Cologuard's commercial launch, from the 2014 Baird Healthcare Conference September 4, 2014.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Nutriband is a transdermal focused pharmaceutical company based in the United States with a goal to improve the safety, comfort and efficacy of existing drugs using transdermal technologies. The Company is developing a pharmaceutical pipeline to improve drug delivery technologies and capabilities for patients, physicians, and payers through transdermal delivery technologies. Nutriband’s lead product is its AVERSA® technology. AVERSA® abuse deterrent transdermal technology incorporates aversive agents to prevent the Abuse, DiVERsion, MiSuse and Accidental exposure of drugs with abuse potential, such as opioids. The Company’s first application for AVERSA® is an abuse deterrent fentanyl transdermal patch which it is developing to provide clinicians and patients a safe extended-release patch for chronic pain. The goal is to make opioid based pain treatments safe for all who need them. AVERSA technology has received patent protection in the European Union, Australia, Japan, Mexico, Russia with patent prosecution in the US and Canada. Nutriband has made sure to target all large applicable markets and its global patent protection has opened up many opportunities for the Company to make a big impact on the safety profile of drugs globally.
Exact Sciences Corp. announced that the company continued its strong performance during the third quarter ended Sept. 30, 2015, completing 34,000 Cologuard tests, an increase of 60 percent from the second quarter, which resulted in $12.6 million in revenues. The cumulative number of ordering physicians grew to 21,000 during the quarter, an increase of 42 percent.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Exact Sciences Company Presentation Baird Healthcare ConferenceExact Sciences
Exact Sciences CEO Kevin Conroy's presentation slides, featuring updates on Cologuard's commercial launch, from the 2014 Baird Healthcare Conference September 4, 2014.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Nutriband is a transdermal focused pharmaceutical company based in the United States with a goal to improve the safety, comfort and efficacy of existing drugs using transdermal technologies. The Company is developing a pharmaceutical pipeline to improve drug delivery technologies and capabilities for patients, physicians, and payers through transdermal delivery technologies. Nutriband’s lead product is its AVERSA® technology. AVERSA® abuse deterrent transdermal technology incorporates aversive agents to prevent the Abuse, DiVERsion, MiSuse and Accidental exposure of drugs with abuse potential, such as opioids. The Company’s first application for AVERSA® is an abuse deterrent fentanyl transdermal patch which it is developing to provide clinicians and patients a safe extended-release patch for chronic pain. The goal is to make opioid based pain treatments safe for all who need them. AVERSA technology has received patent protection in the European Union, Australia, Japan, Mexico, Russia with patent prosecution in the US and Canada. Nutriband has made sure to target all large applicable markets and its global patent protection has opened up many opportunities for the Company to make a big impact on the safety profile of drugs globally.
Exact Sciences Corp. announced that the company continued its strong performance during the third quarter ended Sept. 30, 2015, completing 34,000 Cologuard tests, an increase of 60 percent from the second quarter, which resulted in $12.6 million in revenues. The cumulative number of ordering physicians grew to 21,000 during the quarter, an increase of 42 percent.
Highlights of the fourth quarter of 2010. Net sales amounted to SEK 27,556m (28,215) and income for the period was SEK 677m (664), or SEK 2.38 (2.34) per share. Net sales increased by 1.6% in comparable currencies.
Für die empirische Untersuchung „Mittelstandskommunikation 2016 – Studie zur Professionalisierung, Digitalisierung und Führung der Unternehmenskommunikation“ wurden im Frühjahr 2016 insgesamt 561 Unternehmen in Deutschland befragt, darunter 270 Entscheider aus mittelständischen Unternehmen. Die Studie illustriert den Status quo der Kommunikation in konzernunabhängigen Unternehmen mit maximal 499 Mitarbeitern und einem Umsatz von bis zu 50 Mio. Euro. Das Gemeinschaftsprojekt der Universität Leipzig mit Fink & Fuchs und dem Magazin pressesprecher schließt an die Vorgängerstudie von 2015 an.
Unternehmenskommunikation im Mittelstand wird zunehmend professioneller und digitaler. Aber es fehlen nach wie vor oft klare Kommunikations- und Digitalisierungsstrategien, übergreifende Kommunikationsziele und fachkundige Kommunikationsabteilungen. Zudem behindert die kommunikative Zurückhaltung vieler Unternehmer oft die notwendige Weiterentwicklung in Marketing und Public Relations.
Der 89-seitige Ergebnisbericht ist hier verfügbar. Weitere Informationen finden sich unter www.mittelstandskommunikation.com sowie www.communicationmanagement.de in der Rubrik "Mittelstandskommunikation".
Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE), a diversified molecular diagnostics company. GTG offers cancer predictive testing and assessment tools to help physicians proactively manage patient health. The Company’s lead products GeneType for Breast Cancer and GeneType for Colorectal Cancer are clinically validated risk assessment tests and are first in class. Genetic Technologies is developing a pipeline of risk assessment products. Learn more at GENETechinfo.com.
Genetic Technologies Limited is a diversified molecular diagnostics
company developing tools for the prediction and assessment of cancer
risk to help physicians proactively manage patient health. The
Company’s lead products, ‘GeneType for Breast Cancer’ and
‘GeneType for Colorectal Cancer’, are clinically validated risk
assessment tests that are first in their class. The Company’s
development pipeline includes new tests for COVID-19, Type 2
diabetes, cardiovascular disease, prostate cancer, and melanoma.
Listed on the ASX in 2000 and NASDAQ in 2005, Genetic
Technologies has been a leader in the development and
commercialization of genetic risk assessment technology for 20 years.
Genetic Technologies (NASDAQ: GENE) is a diversified molecular diagnostics company embracing blockchain technologies across genomic testing platforms. GENE offers cancer predictive testing and assessment tools to help physicians proactively manage patient health. The Company’s lead product, BREVAGenplus®, is a clinically validated risk assessment test for non-hereditary breast cancer and is first in its class. For more information, please visit genetechinfo.com.
Based in Ann Arbor, Michigan, Zomedica is a veterinary health company creating diagnostic and therapeutic products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. With modest cash burn and a strong balance sheet, including $142.4 million cash and cash equivalents as of June 30, 2023, Zomedica is well-positioned to fund both organic growth and acquisitions.
Dócola is a social good organization with the only free care communication platform that consolidates thousands of free and low-cost patient education resources from the leading nonprofit, government, and commercial organizations in one marketplace. Plus, you can easily create and upload your own resources.
INNO HOLDINGS INC. is an innovative building-technology company with a mission to transform the construction industry with our proprietary cold-formed steel- framing technology and other building innovations
Everything Blockchain builds platforms of trust for the modern enterprise and is on a mission to ensure every organization has access to the tools and platforms that enable them to manage, store, and protect data without the cost and complexity that holds them back today. The Company’s patented advances in engineering deliver the essential elements needed for real-world business use: speed, security, and efficiency. Everything Blockchain’s current business lines include: EB Advise, Build DB and EB Control.
ASP Isotope is an isotope enrichment company utilizing technology developed in South Africa over the past 20 years to enrich isotopes of elements or molecules with low atomic masses. Many of these elements are unsuitable for enrichment using traditional methods such as centrifuges. The Company’s initial focus is on producing and commercializing highly enriched isotopes for the healthcare and technology industries.
MDNA Life Sciences is a pioneer in the science of mitochondrial DNA. It’s our mission to create an extensive portfolio of proprietary tests that dramatically improve diagnosis, treatment, prognosis and monitoring. Putting an end to the unnecessary surgical procedures, pain and uncertainty that affect patients across the world.
Digital Ally, Inc. is a diversified holding company with operations in video solution technology, human and animal health protection products, healthcare revenue cycle management, ticket brokering and marketing, and event production. The Company pursues an acquisition strategy that targets organizations with positive earnings, strong growth potential, innovation, and operational synergies. To maximize long-term shareholder value, Digital Ally intends to spin-off its ticketing and entertainment business lines into a separate public company in 2023. The spin-off will create two optimized, tech-driven public companies with strong growth opportunities and operating metrics.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
Aditxt is a global innovation company focused on discovering and developing precision medicine innovations and deploying them into high-performing businesses. Aditxt’s diverse innovation portfolio includes: Adimune™, Inc., developing and designing a new class of therapeutics for retraining the immune system to address organ rejection, autoimmunity, and allergies; Adivir™, Inc., focused on identifying, developing and commercializing new ways to treat infectious diseases; and Pearsanta™, Inc., offering convenient, rapid, personalized, and high-quality lab testing —anytime and anywhere at its CLIA certified and CAP accredited clinical laboratory based in Richmond, VA.
1847 Holdings LLC, a publicly traded diversified acquisition holding company, was founded by Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue and Principal of Lazard Freres Strategic Realty Investors. EFSH's investment thesis is that capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises and lower-middle market businesses with limited exit options, despite the intrinsic value of their business. Given this dynamic, EFSH can consistently acquire "solid" businesses for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems to improve operations. These improvements may lead to a sale or IPO of an operating subsidiary at considerably higher valuations than the purchase price (as successfully demonstrated with the mid-2020 IPO of 1847 Goedeker on the NYSE American) and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to EFSH's ability to pay regular and special dividends to shareholders.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
SPI Energy is a global renewable energy company and provider of solar storage and electric vehicle (EV) solutions that was founded in 2006 in Roseville, California and is headquartered in McClellan Park, California. The Company has three core divisions: SolarJuice which has solar wholesale distribution, as well as residential solar and roofing installation and solar module manufacturing (Solar4America & SEM Wafertech), SPI Solar and Orange Power which operates a commercial & utility solar division, and the EdisonFuture/Phoenix Motor EV division. SolarJuice is the leader in renewable energy system solutions for residential and small commercial markets and has extensive operations in the Asia Pacific and North America markets. The SPI Solar commercial & utility solar division provides a full spectrum of EPC services to third party project developers, and develops, owns and operates solar projects that sell electricity to the grid in multiple regions, including the U.S., U.K., and Europe. Phoenix Motor is a leader in medium-duty commercial electric vehicles, and is developing EV charger solutions, electric pickup trucks, electric forklifts, and other EV products. SPI maintains global operations in North America, Australia, Asia and Europe and is also targeting strategic investment opportunities in fast growing green energy industries such as battery storage, charging stations, and other EVs which leverage the Company's expertise and substantial solar cash flow.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BioVie is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
2. Forward Looking Statements
2
This 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 our 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 our control. These statements also involve known and unknown
risks, uncertainties and other factors that may cause our 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, our
ability to adequately finance the business, our ability to restructure our debt and other obligations, the market's acceptance of our
molecular diagnostic tests; our ability to secure additional business and generate higher profit margins through sales of our
molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated
internal rate of return on investments. Additionally, all forward-looking statements are subject to the risk factors detailed from time
to time in our Prospectus Supplement and our periodic filings with the Securities and Exchange Commission (SEC), including
without limitation, the Annual Report on Form 10-K filed with the SEC on March 30, 2016, as amended on April 29, 2016 and
June 14, 2016, and in the company’s Form 10-Q filed with the SEC on November 17, 2016. 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 this Investor Presentation and, except as may be required by law, we undertake no
obligation to revise or update publicly any forward-looking statements for any reason.
3. • Jack E. Stover President & CEO since December 2015. Prior Director of PDI. Director
of Onconova Therapeutics and Viatar CTC. Previously President & CEO of Antares
Pharma and COO of Sicor Inc and CFO/COO of Gynetics Inc. and Partner at PWC
• Sydney Finkelstein MD, CMO and CSO, Founder of RedPath. A board certified
anatomic pathologist with extensive experience and accomplishments in academic
surgical pathology and molecular pathology. Formerly Professor of Pathology at the
Univ. Pittsburgh. Syd has authored over 200 peer review manuscripts and is a nationally
recognized authority in Gastrointestinal Pathology and Solid Tissue molecular
diagnostics.
• Greg Richard Sr. VP Commercial Services. Previously at Aetna and moved to
Genentech as Director of managed care. VP of Managed Care for Quest and Sr. VP of
Sales for LabCorp and a frequent speaker at lab industry conferences
• Jim Early Chief Financial Officer. Previously CFO at ABGenomics Int’l, SVP Finance
and Administration & Corporate Secretary at SynaGeva BioPharma as well as an
interim CFO and BD services consultant to the medtech industry.
Management Team
3
4. Our Mission
4
We provide clinically useful molecular
diagnostic tests and pathology
services for evaluating risk of cancer
by leveraging the latest technology in
personalized medicine for better
patient diagnosis and management.
5. Overview & Key Accomplishments
NASDAQ listed company offering high-margin pre-cancerous diagnosis and prognosis
tests
Growing revenues in proprietary, high-value space
4 proprietary offerings in two key verticals (Endo & GI)— 3 products now covered by
Medicare across multiple regions
High barriers to entry due to reimbursement, complexity of tests and intellectual know
how
Cash collections expanding—$3.3 million in Q2 alone
Achieved New York State approval in Q3 2016
AETNA insurance reimbursement for ThyraMir announced in Q4
Corporate restructuring continuing
5
6. Powered by PathFinderTG®
Our Marketed Molecular Tests
Estimated Current U.S. Market Opportunity
Pancreatic Cysts
$350M
Thyroid Nodules
$350M
GastrointestinaI Endocrine
Source: JAMA, 2012; Archives of Internal Medicine 2009
6
8. The Fourth Leading U.S. Cancer Killer
Cervix Prostate Breast Lung
45,000new U.S. cases
39,590U.S. deaths 4,020
14,270
29,480
39,590 40,430
50,310
159,260
Source: ACS Cancer Facts & Figures 2014; all figures annual
5-year survival rate 7.2%
Pancreatic cancer 3% of new cancer cases in US, 12% of deaths of common cancers
Pancreatic Cancer
8
Leukemia Pancreatic Colon
9. PancraGEN™ (formerly PathfinderTG®)
Imaging Cytology Fluid Analysis
(CEA , Amylase)
Molecular
Diagnostics
Pathologist
Review
• DNA quantity & quality
• Oncogene point mutations
(KRAS, GNAS)
• Loss of heterozygosity (LOH)
25 markers measured
• Detailed quantitative
molecular profiling integrated
with first-line clinical findings
leading to risk assessment and
clear, management
recommendations
PancraGEN – Integrated Molecular Pathology
34%
8%
52%
6%
CEA above 1000 ng/ul with High EUS
Benign
Statistically Indolent
Statistically Higher Risk
Aggressive
+
Virtual risk assessment using 13,000+ testing & 492 cyst registry pts
9
10. 120,000 Pancreatic Cysts Annually
• The clinical dilemma:
– Current guideline tests are unreliable and
poorly predict cancer risk
Cyst fluid tested for CEA, amylase, and
cytology (1st line tests)
• The result:
– 80% of all surgeries are for benign disease3
Unnecessary healthcare costs
High morbidity (30%) and mortality (2%)2
associated with these surgeries
– Pancreatic cancers go undetected
Pancreatic cysts:
2-5%
risk of cancer
increasing with
age1
Pancreatic cysts:
80%
surgeries are
benign
Source: 1Gastroenterology Research and Practice Volume 2012, Article 147465
2Gastroenterology 2015; 148:819-822
3http://www.seenamagowitzfoundation.org/pancreatic-cysts/
10
12. 12
Common clinical problem
~10-18 m
US Adults have nodules
Estimated
525,000
thyroid FNA per year in
US and growing
Thyroid Cancer Incidence*
*American Cancer Society
http://www.cancernetwork.com/thyroid-cancer/thyroid-nodules-when-biopsy
Thyroid Nodules
13. First microRNA gene expression classifier
ThyraMIR™ measures the expression of 10 microRNAs and,
when used in combination with ThyGenX™, yields both high
NPV and high PPV
ThyGenX™ and ThyraMIR™ combination testing can
accurately “Rule in” and “Rule out” the risk of malignancy
ThyGenX™ and ThyraMIR™ combination testing addresses
a unmet clinical need for more actionable information in
the management of indeterminate thyroid nodules
+
13
14. Cancer prevalence: 32%
38% “benign”
with 93% NPV
62% “suspicious”
with 47% PPV
SurgeryFollow
Afirma
Avoidable surgeries: 68% 33%
Indeterminate diagnosis
Combination testing provides accurate molecular reclassification without surgery
• 85% (6.7-fold) decrease in unnecessary surgeries (from 68% to 10%)
• 69% (3.3-fold) decrease in unnecessary surgeries relative to Afirma (from 33% to 10%)
• 65% (1.65-fold) increase in true benign yield relative to Afirma (from 35% to 58%)
•Pts with benign disease avoid surgery, 75% pts with cancer proceed directly to total thyroidectomy (red)
Surgery
68% benign outcome
Indeterminate diagnosis
61% “benign”
with 94% NPV
39% “malignant”
with 74% PPV
Combination testing
SurgeryFollow
10%
Indeterminate diagnosis
14
Yield of Molecular Reclassification
15. • Combined test performance results in a 94% likelihood that a negative result is
truly benign and a 74% likelihood that a positive result is malignant (based on a
prevalence of 32%)
• The 74% likelihood of a positive result being malignant is a vast improvement
over the “50/50” likelihood of the Afirma’s suspicious call
• The benign call rate for ThyGenX/ThyraMIR is superior to Afirma®—allowing up
to 65% more patients to consider a watchful waiting approach
ThyGenX™ / ThyraMIR™ Summary
The end result is a 69% decrease in unnecessary surgeries
relative to the Afirma test. (Labourier et al., JCEM 2015)
+
15
18. How may BarreGEN be useful?
• Current surveillance methods based on histology are inadequate at
assessing risk of disease progression to HGD/EAC
• BarreGEN may help differentiate patients a low risk of EAC from high
risk of EAC prior to visible HGD/EAC morphology
• BarreGEN can allow for more personalized management of Barrett’s
patients including:
• Aid in strategies to prevent cancer (ablation)
• Avoid unnecessary ablative therapy
• Help monitor patients during surveillance
• Reduce healthcare costs
18
19. Results:
• The mean ML in pre-progression biopsies was higher in progressors (2.21) than
nonprogressors (0.42; p<0.0001)
• BarreGEN had a high overall accuracy for predicting progression to cancer (ROC
curve AUC = 0.95, 95% CI 0.89-1), with all loci contributing to this performance
• Prior to progression, accuracy of BarreGEN was highest (90%) at an ML of 1, where
optimal sensitivity (96%) and specificity (87%) were achieved.
Eluri et al 2015 (Our Base Study)
Reprinted from Eluri et al. Am J Gastroenterol 2015; 110:828–834; doi: 10.1038/ajg.2015.152
19
20. Soft launch initiated in H2 2016
Prognostic value in determining cancer progression risk
BASE study Eluri 20151 (n=69)
Diagnostic value in detecting true dysplasia (HGD) in BE
Ellsworth 2012 study2 (n=271) and Khara 2014 study3 (n=415)
Additional clinical studies required
Establish collaborations with Barrett’s Center of Excellence
Excellent partnering opportunity
1 Eluri et al. Am J Gastroenterology 2015, 110:828-834
2 Ellsworth et al. BMC Gastroenterology 2012, 12:181
3 Khara et al. J. Gastrointestinal Cancer 2014 DOI 10.1007/s12029-013-9570-y
BarreGen™ - Multi-stage Introduction
20
21. Patent Portfolio and Proprietary Attributes
21
Thyroid: 9 patents pending- Seven patents on microRNAs as biological markers for distinguishing
benign from malignant thyroid neoplasm. One patent on microRNAs as diagnostic biomarkers to
distinguish benign from malignant thyroid nodules. One patent on the combination
ThyGenX/ThyraMIR assay to classify thyroid nodules.
Pancreas: 3 patents- One on the platform for obtaining molecular information from clinical
specimens and integrating with clinical information (Topographic Genotyping, issued 2001). One
on the diagnosis, determination of malignant potential and biological potential of pancreatic
cysts. One on an improved method for determination of pancreatic cyst fluid CEA levels.
Barrett’s esophagus: Two patents pending- Use of mutational load to assess likelihood of
progression of Barrett’s esophagus and corresponding need for treatment.
Proprietary attributes: 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. Analysis of DNA, mRNA and
microRNA from fresh, cytology and paraffin embedded samples including residual material
contained cell-free nucleic.
22. new U.S. cases
39,590U.S. deaths
Medicare ,
35%
Medicare
Advantage,
19%
Commercial,
29%
Client
Billing, 11%
Others,
6%
PancraGen*
*Payer mix % based on claim submissions; May vary by month
PancraGen and Thryoid Tests - Payor Type Mix
22
Medicare
, 3%
Medicare
Advantage,
9%
Commercial,
52%
Client
Billing, 30%
Others,
6%
Thyroid
23. GI Endocrine
Billing & Reimbursement Overview
23
List Price $4,000
Averaged Realized
Revenue
$2,600
Now Billed Under
Molecular Code
81479
Covered Lives +71 million
List Price $1,675 $4,000
Averaged Realized
Revenue
$1,100 $2,000
Now Billed Under
Molecular Code
81445 81479
Covered Lives +200 million +200 million
24. Source: Cooper DS et al. Thyroid. 2009;19(11):1167-1214; National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Thyroid
Carcinoma. V.1.2014; ATA Guidelines on Thyroid Nodules and Differentiated Thyroid Cancer – Highlights, Consensus, and Controversies. ICE/ENDO conference;
June 21-24, 2014; Chicago, Illinois.
2014 American Thyroid Association Revised Guidelines
MDx Tests should be considered for suspicion of malignancy or indeterminate.
2013 NCCN Guidelines
Molecular Diagnostics recommended testing on some indeterminate cytologies to minimize
unnecessary surgeries
Guideline Recommendations
24
PancraGen™ establishes a new standard for the prognosis and diagnosis of
pancreatic cysts
Current Pancreatic Cysts Guidelines
Sendai guidelines 2012 and ACG guidelines 2007 strongly favor surgical resection because
of the inability of first-line tests to predict biological behavior and aggressiveness.
25. GASTROINTESTIONAL(GI) PRODUCTS
Launched new Biliary product October 3rd, 2016
Launched AccuCEA™ Insights August 1st, 2016
Launched PanDNA™ September 1st, 2016
Launched BarreGen® Clinical Experience Program September 1st, 2016
ENDOCRINE PRODUCTS
Launched Cytopathology Services October 1st, 2016
Launched Cytology Slides as primary specimen October 1st, 2016
Recent Product Developments
26. Income Statement
2016 2015 2016 2015
Revenue, net 3,316$ 2,506$ 9,963$ 6,876$
Cost of revenue 1,846 1,799 4,866 5,224
Gross Profit 1,470 707 5,097 1,652
Sales and marketing 1,282 2,876 4,186 8,387
Research and development 659 1,000 1,339 1,646
General and administrative 2,858 2,498 7,655 8,909
Acquisition related amortization expense 970 986 2,909 2,825
Asset impairment 3,363 - 3,363 -
Change in fair value of contingent consideration (1,174) - (1,174) -
Total operating expenses 7,958 7,360 18,278 21,767
Operating loss (6,488) (6,653) (13,181) (20,115)
Interest expense (539) (884) (1,601) (2,616)
Other income (expense), net 4 (112) 14 (268)
Loss from continuing operations before tax (7,023) (7,649) (14,768) (22,999)
Income tax expense (benefit) 173 (180) (54) (430)
Loss from continuing operations (7,196) (7,469) (14,714) (22,569)
(Loss) income from discontinued operations, net of tax (297) 2,574 101 6,828
Net loss (7,493)$ (4,895)$ (14,613)$ (15,741)$
Basic and diluted income (loss) per share of common stock:
From continuing operations (0.40)$ (0.48)$ (0.82)$ (1.48)$
From discontinued operations (0.02) 0.16 0.01 0.45
Net loss per basic and diluted share of common stock (0.41)$ (0.31)$ (0.81)$ (1.03)$
Weighted average number of common shares and
common share equivalents outstanding:
Basic and Diluted 18,163 15,654 18,029 15,301
Interpace Diagnostics Group, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
September 30,
Three Months Ended Nine Months Ended
September 30,
27. Other Select Financial Information
September 30, December 31,
2016 2015
Cash and cash equivalents 1,693$ 8,310$
Total current assets 6,683 19,165
Total current liabilities 19,870 23,373
Total assets 45,964 67,712
Total liabilities 47,443 54,674
Total stockholders' (deficit) equity (1,479) 13,038
Selected Cash Flow Data
($ in thousands)
2016 2015
Net loss (14,613)$ (15,741)$
Net cash used in operations (6,617)$ (13,536)$
Net cash used in investing activities - (583)
Net cash used in financing activities - (37)
Change in cash and cash equivalents (6,617) (14,156)
Cash and equivalents, Beginning 8,310 23,111
Cash and equivalents, Ending 1,693$ 8,955$
For the Nine Months Ended
Selected Balance Sheet Data
($ in thousands)
September 30,