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Berlin (Germany), June 17, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology, today reported new study results suggesting that Epi proColon, a colorectal cancer screening test approved for patients who are unwilling or unable to be screened by recommended methods may also be an important complement to colonoscopy for CRC screening in patients with LS, a hereditary disease associated with a 10-80% increase in the risk of developing CRC. The study results appear in the current issue of BMJ Open Gastroenterology.^[1]

There is currently no cure for LS, therefore, routine screening that enables early detection and treatment of precancerous lesions has the potential to reduce the risk of CRC and to save lives. Approximately 95 percent of individuals with LS are unaware of their disease status, and nearly a third of patients who know their LS status fail to comply with the recommendation to undergo colonoscopy screening every one to two years. This study evaluated a new approach that could potentially enhance CRC screening for LS patients, which is crucial to reducing the morbidity and mortality associated with the disease.

The study was conducted as a retrospective analysis of preserved tissue and frozen plasma samples from patients with a confirmed diagnosis of LS who underwent either surgical resection for a diagnosis of CRC or removal of a polyp during colonoscopy between March 2006 and February 2019. Study objectives included a comparison of SEPTIN9 gene methylation status (the marker measured by Epi proColon) between patients with LS and patients with non-hereditary forms of CRC and exploratory analyses of the sensitivity and specificity of Epi proColon in LS patients. Key findings from the study include:

• In tissue samples from LS patients, differential SEPTIN9 methylation was found in 97.3% of primary CRC and 90.0% of advanced adenomas, demonstrating that LS-related neoplasia frequently produce the SEPTIN9 biomarker.
• Of 20 plasma samples collected between 138 and 1 days prior to surgical resection of a primary CRC tumor, all had valid tests and 14 were SEPTIN9 positive, for a sensitivity of 70.0%.
• Of 18 plasma samples collected within one year (328 days to 20 days) prior to a colonoscopy-based diagnosis of CRC, 17 had valid tests, and three of the 17 were SEPTIN9 positive. These three were among five patients with a colonoscopy-based stage I-III CRC diagnosis, for a sensitivity to detect CRC approximately two months prior to diagnosis of 60%.
• Of 13 plasma samples collected after surgical resection of a primary CRC tumor, all had valid tests and 12 were SEPTIN9 positive, for a sensitivity to detect metastatic CRC of 92.3%.
• Of 34 plasma samples from a cancer-free control group, 31 had valid tests and all were SEPTIN9 negative, for a specificity of 100%.

The study authors conclude that Epi proColon may have similar diagnostic performance characteristics in LS patients as in the average-risk population and suggest that a larger, prospective study to confirm these preliminary findings is warranted.

“The sensitivity and specificity that the Epi proColon blood test demonstrated in this first study in LS patients are very promising,” said Megan Hitchins, PhD, Associate Professor, Center for Bioinformatics and Functional Genomics at Cedars-Sinai and lead author on the study publication. “Although preliminary, the study results suggest that Epi proColon may have potential as a screening tool for colorectal cancer in LS and for post-surgical detection of metastatic disease as well. Epi proColon may provide an alternative CRC screening method for the LS patients who are non-compliant with colonoscopy screening recommendations. Confirmation of our findings in larger, prospective studies would be an important advance in the clinical management of LS. Dr. Henry Lynch, the first to identify LS cancers as hereditary and the senior author on this, passed away last week. I can think of no better way to honor his already substantial legacy than to continue advancing the care and outcomes for LS patients.”

“Although colonoscopy is the gold standard for CRC screening, diagnosis and polyp removal, compliance with colonoscopy screening recommendations is suboptimal, even among patients with an LS diagnosis who know that they are at increased risk of CRC and could benefit from CRC screening every one to two years,” said Greg Hamilton, Chief Executive Offer of Epigenomics AG. “Pre-cancerous lesions can progress to invasive CRC very rapidly in LS patients, so the 10-year colonoscopy screening interval recommended for average-risk individuals does not adequately protect patients with undiagnosed LS from a late-stage CRC diagnosis, even if they are compliant. Alternative screening methods that could be used in the interval between colonoscopies, such as Epi proColon, might increase early detection of CRC for undiagnosed LS patients and other individuals with increased, but undiagnosed CRC risk.”
 

About colorectal cancer (CRC)

Colorectal cancer remains a leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35% of eligible U.S. patients are not being screened regularly. The unscreened population disproportionately results in 43% of new colorectal cancer cases and about 76% of colorectal cancer deaths and costs. Approximately $18 billion is spent annually on this preventable disease. Over $13 billion is spent on cases from unscreened individuals.

By increasing screening and detecting more cancers early, the costs and deaths from this disease both can be addressed.
 

About Lynch Syndrome

Lynch Syndrome (LS) is a hereditary disorder caused by a mutation in one of at least five genes (MLH1, MSH2, MSH6, MPS2 or EPCAM) that are involved in the repair of mistakes that occur when DNA is copied in preparation for cell division. The accumulation of errors in DNA can result in cells that grow uncontrolled and may become cancerous. Individuals with LS have an increased risk of developing colorectal cancer, endometrial cancer, and various other types of aggressive cancers, often at a young age. Lynch tumors are extremely aggressive and may metastasize more rapidly (less than two year) than sporadic cancer (often more than five years). Consequently, it is recommended that LS patients undergo CRC screening more frequently than the individuals with average CRC risk (every 1-2 years for LS compared with every 10 years in the average risk population) and beginning at an earlier age. A key challenge in achieving these screening recommendations is that only 5% of affected individuals are aware of their LS status.
 

About Epi proColon(R)

Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods. It is a qualitative, in vitro diagnostic blood test for CRC that uses real-time PCR to detect methylation of a target DNA sequence within the Septin 9 gene promoter; methylation of this DNA sequence is associated with the occurrence of CRC and can be detected in cell-free DNA that circulates in the plasma.

For patients, the test only requires a simple blood sample draw as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

Epi proColon is recipient of the 2019 Excellence in Molecular Diagnostics by Corporate LiveWire’s Innovation and Excellence Awards.

For more information on Epi proColon, visit www.epiprocolon.com.

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R) and HCCBloodTest, blood-based tests for lung and liver cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact in the U.S.
David Bull
Director of Marketing
Phone: 240.912.6430
David.Bull@Epigenomics.com

Contact Epigenomics AG
Frederic Hilke
IR.on AG
Phone +49 221 9140 970
ir@epigenomics.com

Media Contact – Lazar Partners
Erich Sandoval
917-497-2867
esandoval@lazarpartners.com

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

^[1] Hitchins MP, Vogelaar IP, Brennan K, Haraldsdottir S, Zhou N, Martin B, et al. Methylated SEPTIN9 plasma test for colorectal cancer detection may be applicable to Lynch syndrome. BMJ Open Gastro. 2019;6:e000299. doi:10.1136/bmjgast-2019-000299.

Berlin (Germany) and San Diego, CA (U.S.A.), June 4, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”) today announced that company management will be presenting at the Raymond James Life Sciences and MedTech Conference in New York on Tuesday, June 18, 2019, at 1:50 pm (EDT) / 7:50 pm (CET) and invites investors to participate by webcast. The webcast can be accessed via the following link http://wsw.com/webcast/rj115/epgny/ as well as in the investor relations section of Epigenomics’ website at www.epigenomics.com.

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R) and HCCBloodTest, blood-based tests for lung and liver cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact
Company
Epigenomics AG
Geneststrasse 5,
10829 Berlin
Tel +49 (0) 30 24345 0
Fax +49 (0) 30 24345 555
E-Mail: contact@epigenomics.com

Investor Relations
Frederic Hilke
IR.on AG
Phone +49 221 9140 970
ir@epigenomics.com

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

New Report Shows CRC Screening Rates Increased When a Medically Underserved Population is Offered Epi proColon^(R) Blood Test

• Data Presented at DDW 2019 Show 93.6% Acceptance Rate Among Patients Unwilling or Unable to Complete Other CRC Screening Tests

Berlin (Germany) and San Diego, CA (U.S.A.), May 20, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology, today reported new results that underscore Epi proColon(R) colorectal cancer’s (CRC) high acceptance rate compared with stool-based screening tests in a medically underserved population in South Florida. The results were presented today in a poster session at Digestive Disease Week(R) (DDW(R)) 2019 in San Diego. Epi proColon received U.S. Food and Drug Administration approval in 2016 and is indicated for the screening of adults ages 50 years or older who have an average risk for CRC and who have been offered and have a history of non-compliance with CRC screening.

“CRC screening is known to reduce the incidence and increase survival of this deadly disease,” said Amar R. Deshpande, MD, Associate Professor of Clinical Medicine at the University of Miami and senior author on the report. “Despite its clear benefits, CRC screening in medically underserved populations is challenging due in part to its cost and accessibility. While previous studies have found low rates of uptake with stool-based screening tests, the results presented today demonstrate that a blood-based test has a high acceptance rate in this population. These findings suggest Epi proColon could help improve CRC screening rates in medically underserved populations, which is a critical step in reducing their CRC-associated risks.”

Dr. Deshpande’s colleagues presented the data today in a poster titled “Increasing uptake of colon cancer screening in a medically underserved population with the addition of blood-based testing” (Abstract #1667). Participants attended free health fairs hosted by the University of Miami Mitchell Wolfson Sr. Department of Community Service (DOCS) in South Florida, between April 2017 and April 2018. Those eligible for screening and at average risk for CRC were offered a stool-based fecal immunohistochemical test (FIT), and those who declined FIT were then offered the Epi proColon blood test. Blood samples were drawn from participants who accepted Epi proColon and sent for analysis. Participants with positive Epi proColon results were contacted by student navigators to try to facilitate colonoscopy. Key findings from the report include:

• Of 1,241 health fair attendees, 249 were eligible to participate in CRC screening.
• A total of 233 eligible participants (93.6%) elected to undergo Epi proColon screening.
• Of the 249 eligible participants, only 16 (6.4%) elected to receive a take-home FIT, of which only 1 was returned for processing.
• In free health fairs conducted in the prior year, which only offered FIT, 414 accepted FIT and 52 (12.5%) were processed.

The authors conclude that the availability of the Epi proColon blood test resulted in a marked increase in screening uptake compared with FIT in medically underserved patients.

“Approximately one-third of Americans are not in compliance with current CRC screening recommendations,” said Greg Hamilton, Chief Executive Offer of Epigenomics AG. “Improving screening rates in this population demands new testing approaches that overcome the patient barriers that lead to non-compliance. The results presented today add to the growing body of data demonstrating a high acceptance rate of Epi proColon. We believe that the best CRC screening test is the one that gets done, and we are proud that Epi proColon is helping to reduce barriers to potentially lifesaving screening that gives patients and physicians important information that they can use to reduce CRC risks.”

About colorectal cancer (CRC)

Colorectal cancer remains a leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35% of eligible U.S. patients are not being screened regularly. The unscreened population disproportionately results in 43% of new colorectal cancer cases and about 76% of colorectal cancer deaths and costs. Approximately $18 billion is spent annually on this preventable disease. Over $13 billion is spent on cases from unscreened individuals.

By increasing screening and detecting more cancers early, the costs and deaths from this disease both can be addressed.

About Epi proColon(R)

Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods. It is a qualitative, in vitro diagnostic blood test for CRC that uses real-time PCR to detect methylation of a target DNA sequence within the Septin 9 gene promoter; methylation of this DNA sequence is associated with the occurrence of CRC and can be detected in cell-free DNA that circulates in the plasma.

For patients, the test only requires a simple blood sample draw as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

Epi proColon is recipient of the 2019 Excellence in Molecular Diagnostics by Corporate LiveWire’s Innovation and Excellence Awards.

For more information on Epi proColon, visit www.epiprocolon.com.

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R) and HCCBloodTest, blood-based tests for lung and liver cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact in the U.S.
David Bull
Director of Marketing
Phone: 240.912.6430
David.Bull@Epigenomics.com

Contact Epigenomics AG
Frederic Hilke
IR.on AG
Phone +49 221 9140 970
ir@epigenomics.com

Media Contact – Lazar Partners
Erich Sandoval
917-497-2867
esandoval@lazarpartners.com

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

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Published to the market and investors on 16^th May 2019 @ 7.02am (BST).

Epigenomics (ECX-DE): Key catalysts to fuel growth throughout 2019
Recommendation: OUTPERFORM
Target Price: EUR4.01
Current Price: EUR1.90 (CoB on 15^th May 2019)

KEY TAKEAWAY

Epigenomics reported Q1/2019 sales of EUR331k (7% YoY), driven largely by a 198% YoY increase in product revenue, which was in part offset by lower licensing revenue due to the recently announced termination of the collaboration with Chinese licensing partner BioChain. We expect solid underlying growth momentum to continue throughout 2019, with back-end loaded revenue generation in Q3 and Q4 fuelled by a number of commercial as well as regulatory catalysts that can unlock significant sales potential for Epi proColon as well as support the commercialisation of HCCBloodTest, the latest addition to Epigenomic’s growing portfolio of liquid biopsy tests, which allows for blood-based detection of liver cancer. We continue to see the positive commercial outlook of Epigenomic’s liquid biopsy tests due to a differentiated profile, fast readouts, large target markets and a significant health-economic impact. We maintain and reiterate both our OUTPERFORM recommendation and EUR4.01 target price (“TP”).

Q1/2019 financial results

Epigenomics reported total Q1/2019 revenue of EUR331k, an increase of 7% compared to Q1/2018. Total revenue was primarily driven by strong product sales growth (198% YoY), which was in part offset by a decrease in licensing revenue due to termination of the distribution agreement with Chinese partner BioChain. Other income attributable to exchange rate gains amounted to EUR499k (vs. EUR10k in Q1/2018). R&D expenses of EUR1.6m were broadly in line with last year (2% YoY), while SG&A expenses increased significantly to EUR2.4m from EUR1.8m (32% YoY) as a result of higher marketing expenses to fuel commercial development. Epigenomics closed Q1 with an improved net loss position of EUR-3.0m (-6% YoY) and as of March 31, 2019, cash stood at EUR12.9m, which should allow the company to fund operations well into 2020E.

Continued progress on CMR coverage for Epi proColon

Epigenomics recently announced that the Centers for Medicare & Medicaid Services (“CMS”) has accepted the company’s application for a National Coverage Determination (“NCD”) review of Epi proColon, which constitutes one of two pathways to obtaining CMS coverage. While CMS have not yet initiated the review process due to a lack of resources available at present, CMS will issue a proposed decision within six months of starting the process, which management expect to begin in due course. A positive decision would represent a major breakthrough for Epigenomics, and we anticipate on-going updates on timelines and assume share price momentum along with positive news flow.

Rich news flow expected to catalyse growth throughout 2019

Having reached a number of critical milestones in 2018, we expect the positive momentum to continue throughout 2019 and anticipate rich news flow driven by (1) publication of the results from the microsimulation study in Q2/2018, paving the way for inclusion into the colorectal cancer screening guidelines, (2) a potential green light from the CMS for Epi proColon, which would translate into immediate coverage in the US, (3) progress on the prospective clinical study for liver cancer detection, and (4) an update on a new distribution agreement in China. As such, 2019 represents a decisive year for Epigenomics that, in our view, could lay a solid foundation for sustainable long-term growth.

Valuation suggests ample upside

With the recent CE marking for HCCBloodTest, in our view, the key uncertainty remains medicare coverage and inclusion into medical guidelines for Epi proColon. With the new liver product de-risking the commercial outlook, Epigenomics offers a highly attractive investment opportunity with significant potential for growth. We maintain and reiterate both our OUTPERFORM recommendation and TP of EUR4.01.

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