NEW YORK — Epigenomics on Monday said that it has adjusted its earnings guidance for 2022 amid currency gains and lower-than-anticipated costs associated with a newly initiated clinical study of its liquid biopsy test for colorectal cancer.
For full-year 2022, Epigenomics now expects its adjusted EBITDA loss to be in the range of €10.5 million ($10.5 million) to €11.5 million, with a cash burn between €14.5 million and €15.5 million. The German molecular diagnostics firm had previously been expecting its 2022 EBITDA loss and cash consumption to arrive between €15.0 million and €17.0 million.
Epigenomics said it continues to expect revenues between €300,000 and €800,000 for full-year 2022.
In addition to currency gains, Epigenomics' guidance was impacted by lower initial setup costs for a prospective multicenter clinical study of the firm's next-generation blood-based colorectal cancer test.
The study, which has enrolled its first subject, is set to include over 15,000 individuals aged 45 and older who are at average risk for colorectal cancer. Clinical outcomes from the trial will be used to support a planned premarket approval submission for the test with the US Food and Drug Administration, Epigenomics said.
Earlier this year, Epigenomics said that it would no longer market its Epi proColon blood-based colorectal cancer test after it was denied coverage by the US Centers for Medicare and Medicaid Services in early 2021. Instead, Epigenomics has turned its attention to the new test, which the company said would automatically receive reimbursement should it be approved by the FDA and meet the criteria for blood-based colorectal cancer screening tests set by the CMS.