COMPANY:

Epigenomics

"Epigenomics AG...closed...the agreement entered into on July 24, 2023 with New Day Diagnostics LLC ('New Day Diagnostics'), a U.S.-based diagnostics and contract research company, for the sale of its major assets. As a result, almost all of the Company’s assets have been transferred to New Day Diagnostics...The sale also offers the realistic possibility that Epigenomics’ intensive upfront work will benefit patients through the further development of the blood-based colorectal cancer screening test."

"Epigenomics AG...and New Day Diagnostics LLC...entered into an agreement for the sale of substantially all of the Company’s assets...The sale of the assets to New Day Diagnostics is expected to enable the commercialization of Epi proColon 'Next-Gen' and secure future cash flows for Epigenomics AG. In addition, the likelihood of reimbursement by CMS increases due to the option to combine the biomarkers of Epigenomics AG and New Day Diagnostic LLC, allowing the 'Next-Gen'-Test to make an important contribution to reducing the burden of colorectal cancer disease and deaths."

"Epigenomics AG...has decided to restructure the Company and to significantly reduce the Company’s operations...The Restructuring is carried out to minimize the Company’s costs. In addition, this is intended to extend the time period available to the Company to secure financing for the further development of the 'Next-Gen'-test for detecting colorectal cancer (CRC)...The Company will stop the sale of Epi proColon and recall the product."

"Epigenomics Inc...announced...The new updated version of the “Next-Gen” assay, which incorporates in-licensed technology, achieved 84% sensitivity at 90% specificity and an advanced adenoma detection rate of 20% in pre-clinical testing. Results were based on a total of 241 subjects, ranging in age from 45-to-85, excluding advanced adenomas and including 70 CRC positive samples equally distributed between early (Stages 1&2) and late (Stages 3&4) stages of the disease. The Next-Gen test is a simple, easy to use, multiomics-solution that employs both DNA methylation markers with protein targets to assess an individual patient’s risk of having colorectal cancer."

"Epigenomics Inc...announced that it has licensed from The University of Texas MD Anderson Cancer Center certain patent and technology rights to biomarkers associated with colorectal cancer detection...Epigenomics intends to utilize this technology to complement its “Next-Gen” blood-based colorectal cancer screening test, which includes protein biomarkers as well as the Company’s proprietary DNA methylation markers such as Septin9."

"Epigenomics Inc...announced it has enrolled its first subject in a new pivotal clinical trial supporting the Company’s 'Next-Generation' blood-based diagnostic screening test for the detection of colorectal cancer (CRC)...The prospective, multi-center study titled CRC-DRAW (CRC–Detection Reliable Assessment With Blood) will enroll screening eligible participants 45 years of age and older who are at average risk for colorectal cancer."