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Epigenomics AG Reports Financial Results for the First Quarter of 2023

Berlin (Germany) and San Diego, CA (USA), May 31, 2023 – Epigenomics AG (FSE: ECX, the “Company”) today reported financial results (IFRS, unaudited) for the first three months of 2023.

Financial key figures

• Revenues in the first quarter of 2023 increased slightly year-on-year from EUR 115 thousand to EUR 134 thousand.
• R&D expenses decreased to EUR 1,121 thousand in Q1 2023 (Q1 2022: EUR 1,401 thousand) as research and development activities were discontinued due to the restructuring of the Company.
• Selling and administrative expenses increased from EUR 2,015 thousand to EUR 4,767 thousand. The increase was due to costs for the realization of the restructuring.
• EBITDA (before expenses for share-based payment expenses) amounted to EUR -4,427 thousand in the reporting period, compared with EUR -2,574 thousand in the same period of the previous year.
• The net loss for the period was EUR -5,591 thousand (Q1 2022: EUR -2,657 thousand); the loss per share¹ increased from EUR -0.66 to EUR -1.31 compared to the same period of the previous year.
• Cash consumption decreased slightly to EUR 3,272 thousand in the first quarter of 2023 (Q1 2022: EUR 3,408 thousand).
• As of March 31, 2023, the Company had cash and cash equivalents of EUR 6,887 thousand (December 31, 2022: EUR 10,126 thousand).

Operational developments

• As the Company was not able to raise additional capital to secure funding for the FDA pivotal study of the “Next-Gen” test, the restructuring of Epigenomics AG was initiated on February 15, 2023. Against this backdrop, among other things, sales of the Epi proColon test were discontinued and the admission to the Prime Standard of Frankfurt Stock Exchange was revoked. Admission to trading in the General Standard is expected to take place on June 12, 2023. In addition to reducing the number of employees at the Berlin and San Diego sites, the Supervisory Board is to be reduced to three members. The Company remains committed to maximizing the value of its technology through corporate partnering, out-licensing and/or asset sales.
• Heino von Prondzynski resigned as Chairman of the Supervisory Board on February 10, 2023, for health reasons and as a contribution to cost reduction and left the Supervisory Board on that date. The Board elected Dr. Helge Lubenow as his successor as the new Chairwoman of the Supervisory Board.
• On April 12, 2023, the Company announced the resignation of Chief Executive Officer Greg Hamilton effective June 30, 2023. On May 19, 2023, the Company further announced the resignation of Executive Board member and Chief Scientific Officer Dr. Andrew Lukowiak effective May 31, 2023. The changes in the Executive Board were made to minimize costs in the course of Epigenomics’ restructuring.

Outlook 2023

• The Company confirms its outlook for fiscal year 2023 and expects EBITDA (before expenses for share-based payment expenses) to be within the range of EUR -7.0 million to EUR -9.0 million.

• In terms of cash consumption, Epigenomics forecasts a range of EUR 7.0 million to EUR 9.0 million for the current full year 2023.

More information

The interim statement for the first three months of 2023 (unaudited) can be found on Epigenomics’ website at: https://www.epigenomics.com/news-investors/financial-reports/.

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 developed blood tests for various cancer indications with high unmet medical need.

For more 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, Email:  contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, Email: ir@epigenomics.com

Note on 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 forward-looking 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.

¹For reasons of comparability, the figure for Q1 2022 was adjusted retrospectively.

Epigenomics AG: Changes in the Management

Berlin, Germany, May 19, 2023 – In connection with its revised strategy, Epigenomics AG (Frankfurt Prime Standard: ECX1, OTCQX: EPGNY) announces changes to its Executive Board. The Member of the Executive Board, President, and Chief Scientific Officer of Epigenomics AG (Frankfurt Prime Standard: ECX1, OTCQX: EPGNY; the “Company”), Dr. Andrew Lukowiak, is resigning from the Company and the Executive Board effective May 31, 2023.

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

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, Email: ir@epigenomics.com

Note on 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 forward-looking 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.

Epigenomics AG: Member of the Executive Board and Chief Scientific Officer Andrew Lukowiak Resigns
 

Berlin (Germany), May 19, 2023 -The Member of the Executive Board, President, and Chief Scientific Officer of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”), Dr. Andrew Lukowiak, and the Company’s Supervisory Board today agreed on his resignation from the Company and the Executive Board effective May 31, 2023.   Between now and the resignation date Dr. Lukowiak will continue to support the Company’s restructuring efforts in coordination with the Supervisory Board.  The Company continues to be committed to maximizing the value of its technology through corporate partnering, licensing and/or asset sales.

Dr. Helge Lubenow, Chairwoman of the Supervisory Board of Epigenomics AG, thanked Andrew Lukowiak on behalf of the entire Supervisory Board: “Andrew Lukowiak has very successfully led the development and pre-clinical validation of our “Next-Gen” colorectal cancer screening test over the last 15 months and has driven the process with his experience and strategic vision.”

Dr. Lukowiak has been a Member of the Executive Board, President, and CSO of Epigenomics AG since December 2021.  His broad contributions across the organization have been instrumental in furthering the Company’s colorectal cancer diagnostics’ program, including his systematic optimization of R&D structure and processes, as well as his execution of complementary partnerships. However, in recent months, in the current capital market environment, the Company has been unable to raise additional capital to secure funding for the FDA pivotal study of the “Next-Gen” test. In response, the restructuring of the Company was initiated on February 15, 2023 to minimize costs. Against this backdrop, the resignation of Dr. Andrew Lukowiak now also takes place.

The Supervisory Board will decide on the further composition of the Executive Board in due course.

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 developed blood tests for various cancer indications with high unmet medical need.

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, Email: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, Email: ir@epigenomics.com

Note on 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 forward-looking 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.

Epigenomics AG publishes financial results for fiscal year 2022

Berlin (Germany) and San Diego, CA (U.S.A.), April 28, 2023 – Epigenomics AG (FSE: ECX, the “Company”) today reported financial results (according to IFRS) for fiscal year 2022.

FINANCIAL RESULTS 2022

• Revenues decreased to EUR 0.5 million in fiscal year 2022, compared to EUR 6.2 million in the previous year. The prior year included revenues from the sale of samples from the Company’s blood sample database (the “Biobank”) in the amount of EUR 5.7 million.
• Research and development costs in 2022 increased from EUR 3.1 million in the previous year to EUR 6.7 million, mainly due to the discontinuation of pandemic-related short-time work, the initiation of the pre-clinical study on Epi proColon “Next-Gen” as well as the new employees hired in the U.S.A. to conduct the study.
• Selling, general and administrative costs amounted to EUR 6.6 million (2021: EUR 7.5 million). In the previous year, costs were still incurred in connection with the biobank sale.
• Other income of EUR 1.9 million (2021: EUR 3.2 million) was largely to exchange rate volatility in the EUR/USD pair. Therefore, a total of EUR 1.8 million arose from exchange rate gains (2021: EUR 2.8 million).
• EBITDA (before share-based payment expenses) was EUR -11.3 million in the reporting period and was thus significantly better than assumed at the beginning of 2022. The forecast for adjusted EBITDA was within a range of EUR -15.0 million to EUR -17.0 million at the beginning of the year and was adjusted to EUR -11.0 million to EUR -11.6 million subsequently. As in the case of revenue, the significant difference compared to the previous year is attributable to the sale of samples from the biobank in 2021.
• Accordingly, the net loss also increased to EUR -12.0 million (2021: EUR -2.4 million); the loss per share increased from EUR -0.87 to EUR -2.96 compared to the previous year.
• Cash consumption increased to EUR 13.7 million in 2022, compared with EUR 4.2 million in the previous year.
• As of December 31, 2022, the Company had cash and cash equivalents of EUR 10.1 million (December 31, 2021: EUR 23.0 million).

OPERATIONAL DEVELOPMENTS

• Despite very convincing preclinical data of the Epi proColon “Next-Gen” test for the detection of colorectal cancer (CRC) – 84% sensitivity and 90% specificity would have enabled Medicare reimbursement after FDA approval – Epigenomics has not been able to secure the necessary funding for the further development of the test. Facing a significant deterioration in the conditions for venture capital in the financial markets, the Company has initiated extensive restructuring measures in February 2023 to reduce cash consumption.
• In this regard, among others, the FDA pivotal clinical study CRC-Draw, which was initiated in September 2022, was placed on hold, the American Depository Receipts program was terminated and the sale of Epi proColon was discontinued. Furthermore, the revocation of the admission of Epigenomics AG’s shares to the Prime Standard was applied for, effective as of June 9, 2023. Trading of the shares in the General Standard is expected to start on June 12, 2023. No restrictions on the trading of Epigenomics AG shares are expected.
• Effective March 31, 2023, the Chairman of the Supervisory Board, Heino von Prondzynski, resigned his mandate for health reasons and left the Supervisory Board on that date. Dr. Helge Lubenow was elected by the Supervisory Board as its new Chairwoman.
• In addition, Epigenomics AG’s CEO Greg Hamilton and the Company’s Supervisory Board have reached an agreement on his resignation from the Company and the Executive Board effective June 30, 2023. Until then, Greg Hamilton will manage the restructuring measures, potential out-licensing and potential sales of patents and biobanks in coordination with the Supervisory Board.
• Based on the measures taken, Epigenomics AG expects that the available financial resources will be sufficient until the first half of 2025. This assessment is based on current forecasts and the success of the action taken is subject to uncertainties so that actual results could differ materially from these assumptions and may constitute a going concern risk.

Greg Hamilton, CEO of Epigenomics AG: “The future success of the Company will depend on our ability to create value for shareholders by out-licensing “Next-Gen” or by selling patents and biobanks. We recognize the difficult financial situation of the Company and the impact of the restructuring on our employees, customers, and investors. We will look to maximize the opportunities in front of us with the limited resources currently available.”

OUTLOOK 2023

EBITDA / cash consumption

• For EBIT as well as EBITDA before share-based payment expenses, Epigenomics forecasts a range of EUR -7.0 million to EUR -9.0 million for the current full year 2023. Based on the Company’s 2023 business plan, cash consumption is expected to be in line with the EBITDA guidance between EUR -7.0 million and EUR -9.0 million.

More information

The Annual Report 2022 is available on the Epigenomics’ website at:
https://www.epigenomics.com/news-investors/financial-reports/.

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 developed blood tests for various cancer indications with high unmet medical need.

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, Email: contact@epigenomics.com

Investor Relations

IR.on AG, Frederic Hilke, Tel +49 221 9140 970, Email: ir@epigenomics.com

Note on 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 forward-looking 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.