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Supervisory Board of Epigenomics AG Appoints Dr. Andrew Lukowiak as President and Chief Scientific Officer

• Dr. Andrew Lukowiak is a proven senior executive with deep technology and development expertise
• Appointment underscores Epigenomics’ commitment to the opportunity for Epi proColon “Next-Gen”, the company’s enhanced blood-based colorectal cancer screening test
• New President and Chief Scientific Officer to join Epigenomics on December 1, 2021

Berlin (Germany) and San Diego, CA (U.S.A.), November 18, 2021 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”), the German-American cancer molecular diagnostics company, announced today that the Supervisory Board appointed Dr. Andrew Lukowiak as President and Chief Scientific Officer with effect from December 1, 2021. Dr. Lukowiak, who has held senior management positions in the U.S. molecular diagnostics industry, will become a member of the Executive Board of Epigenomics and oversee Research and Development and Operations.

Dr. Lukowiak (49) has over 20 years of management experience in the molecular diagnostics and life sciences industries. Prior to joining Epigenomics, Andrew served as CEO and Board Member for Millennium Health, a leading specialty toxicology laboratory. Dr. Lukowiak was also Chief Operating Officer of AltheaDx Inc., where he led the development, validation and launch of multiple Real-Time PCR tests for a broad array of disease states. Additionally, he was a senior R&D executive at GenMark Diagnostics and Hologic, where he was responsible for both PMA and 510(k) cleared products including the support and automation of an HPV test for cervical cancer. Dr. Lukowiak earned his doctorate in Genetics from the University of Georgia and his Bachelor of Science in Biology from Pennsylvania State University.

Heino von Prondzynski, Chairman of the Supervisory Board, stated: “The Supervisory Board is excited to add the significant executive management, clinical and technical expertise that Andrew brings to the Executive Board of Epigenomics AG. Dr. Lukowiak has continually demonstrated the ability to deliver innovative tests through the FDA and the reimbursement process that have then led to commercial success. His breadth and depth of experience is ideally suited for Epigenomics to successfully execute the strategic plan for Epi proColon “Next-Gen”.”

“I am excited to join the Epigenomics team and execute the plan for Epi proColon Next-Gen”,” said Dr. Lukowiak. “Epigenomics’ “Next-Gen” blood-based cancer test has the potential to significantly improve colon cancer screening rates and save lives. The company’s leadership and innovation in liquid biopsy is an ideal platform to deliver an easy-to-use Real-time PCR based solution for hospital-based laboratories.”
 

About Epigenomics
Epigenomics AG is a molecular diagnostics company focused on blood testing for the early detection of cancer. Based on its proprietary biomarker technology for the detection of methylated DNA, Epigenomics develops and markets blood tests for various cancer indications with high unmet medical need. Epigenomics’ lead product is the blood test Epi proColon(R) for the early detection of colorectal cancer. Epi proColon is approved by the U.S. Food and Drug Administration (FDA) and is marketed in the United States and Europe as well as other selected countries. HCCBloodTest, a blood test for the detection of liver cancer, have received the CE Mark for marketing in Europe.

For further information please 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
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, E-Mail: 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 expected 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.

Epigenomics AG publishes financial results for the first nine months 2021

Berlin (Germany) and San Diego, CA (U.S.A.), November 10, 2021 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the “Company”) today reported financial results (IFRS, unaudited) for the first nine months of 2021.

9M 2021 FINANCIAL RESULTS

• Total revenue in the first nine months of 2021 increased to EUR 6,022 thousand (9M 2020: EUR 541 thousand), due to the sale of samples from the Company’s “biobank” in the amount of EUR 5,675 thousand. Product revenue decreased from EUR 453 thousand to EUR 330 thousand in the reporting period compared to the same period of the previous year due to the Covid-19 pandemic.
• Research and development costs decreased from EUR 3,412 thousand to EUR 2,226 thousand in the nine-month period due to a reduction in clinical study costs related to Covid-19; however, patient enrollment for the Epi pro Colon post-approval study has recently begun to increase closer to pre Covid 19 levels.
• Selling and administrative expenses increased slightly from EUR 5,442 thousand to EUR 5,809 thousand primarily due to the costs associated with the sale of the Biobank samples.
• EBITDA (before share-based payment costs) improved significantly to EUR -209 thousand in the reporting period compared to EUR -8,090 thousand in the same period of the previous year. This is also primarily due to the biobank samples sale.
• The net loss for the period also decreased significantly to EUR -691 thousand (9M 2020: EUR -9,109 thousand); accordingly, the loss per share decreased from EUR 1.59 to EUR 0.07 compared to the same period of the previous year.
• Cash consumption decreased to EUR 3,598 thousand in the first nine months of 2021 (9M 2020: EUR 7,492 thousand).
• As of 30 September 2021, the Company had cash and cash equivalents (including marketable securities) of EUR 23,555 thousand (31 December 2020: EUR 3,566 thousand).

OPERATIONAL DEVELOPMENTS

• Epigenomics initiated clinical trial plans for Epi proColon “Next-Gen”, an updated version of the assay that meets CMS reimbursement criteria based upon performance from prospectively collected banked clinical samples. The Company plans to begin enrollment in the summer of 2022.
• In addition, Epigenomics executed a EUR 5.7 million sale of samples from the Company’s extensive biobank. The Company has retained the necessary samples to complete development activities for Epi proColon “Next-Gen”.
• In September the company successfully completed the placement of a subordinated non-interest-bearing mandatory convertible bond that raised EUR 16.5 million in gross proceeds.

OUTLOOK 2021

Revenue

• As a result of the sale of the biobank to New Horizon Health Limited, the revenue and earnings guidance for the full year 2021 was adjusted on August 17, 2021: The Company expects revenues of EUR 6.0 million for the financial year 2021 (previously: EUR 0.4 million to EUR 1.0 million).

EBITDA / cash consumption

• For EBITDA before share-based payment costs, Epigenomics forecasts a range of EUR -3.0 million to EUR -4.0 million (previously: EUR -7.0 million to EUR -9.0 million) for the full year 2021. Based on the Company’s 2021 business plan, cash consumption is expected to range between EUR 3.5 million to EUR 4.5 million (previously: EUR 7.0 million to EUR 9.0 million).

Further information

The financial report for the first nine months of 2021 is available on the Epigenomics’ website at: https://www.epigenomics.com/news-investors/financial-reports/.

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed at the following link: https://www.epigenomics.com/news-investors/financial-reports/

The dial-in numbers for the conference call are (for registered participants):

Dial-in number Germany: +49 30 232531508
Dial-in number UK: +44 1635 598058
Dial-in number U.S.A.: +1 516-269-8975

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Company’s website following the call.
 

About Epigenomics
Epigenomics AG is a molecular diagnostics company focused on blood testing for the early detection of cancer. Based on its proprietary biomarker technology for the detection of methylated DNA, Epigenomics develops and markets blood tests for various cancer indications with high unmet medical need. Epigenomics’ lead product is the blood test Epi proColon(R) for the early detection of colorectal cancer. Epi proColon is approved by the U.S. Food and Drug Administration (FDA) and is marketed in the United States and Europe as well as other selected countries. HCCBloodTest, a blood test for the detection of liver cancer, have received the CE Mark for marketing in Europe.

For further information please 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
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, E-Mail: ir@epigenomics.com.
 

Forward-looking statements

This publication expressly or implicitly contains forward-looking statements concerning Epigenomics AG and its business. These statements involve certain known and unknown risks, uncertainties and other factors that may cause Epigenomics AG’s actual results, financial condition and performance to be materially different from any future results, performance or achievements expressed or implied by such statements. Epigenomics makes this announcement as of the date of this release and does not intend to update any forward-looking statements contained herein as a result of new information or future events or otherwise.