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In Brief This Week: Enzo Biochem, Epigenomics, Co-Diagnostics, Lunit, COLA, More

NEW YORK – South Korean cancer diagnostics and therapeutics firm Lunit this week reported that pending approval by Volpara Health Technologies' shareholders, its proposal to acquire Volpara is expected to be finalized by May. In December, Lunit said it planned to acquire Volpara for A$1.15 (US$.76) per share in a deal valued at A$292 million. Based in New Zealand, Volpara develops software for the early detection of breast cancer. Lunit said this week that the High Court of New Zealand has granted an initial order and all necessary consents under New Zealand regulations have been secured, clearing the way for the deal to move forward. 

Enzo Biochem reported this week a 15 percent increase in its fiscal second quarter revenues to $8.6 million from $7.5 million a year ago. The Farmingdale, New York-based company had a net loss of $3.1 million, or $.06 per share, in Q2 2024 compared to a net loss of $11.3 million, or $.23 per share, in Q2 2023. On an adjusted basis, it had breakeven EPS. It had cash and cash equivalents of $60.2 million as of Jan. 31. 

Epigenomics rthis week eported that its fiscal year 2023 revenues fell 67 percent, to €300,000 ($327,000), compared to €900,000 in the previous year, which the firm said was the result of the firm's decision during restructuring to halt distribution of its Epi ProColon test. It posted a net loss of €4.5 million for the year compared to a loss of €17.3 million in fiscal year 2022. Cash consumption fell to €5.6 million for fiscal year 2023 compared to €10.7 million a year earlier. The firm ended 2023 with €2.1 million in cash and cash equivalents. The Berlin-based firm said in October that it had closed an agreement for the sale of its major assets to New Day Diagnostics for $500,000 and an interest in New Day. This week it said that the sale provided sufficient liquidity for the firm to continue its existence as well as the opportunity to benefit from milestone-based payments related to the commercialization of the Epi ProColon Next-Gen technologies that Epigenomics sold to New Day.

Co-Diagnostics this week announced its full-year 2023 financial results, reporting revenues of $6.8 million for the year, down 80 percent from $34.2 million in 2022 due largely to a decline in demand for its Logix Smart COVID-19 tests. Grant revenue totaled $5.8 million, while product revenue was $1.0 million. Net loss for the year was $35.3 million, or $1.20 per share, compared to a net loss of $14.2 million, or $.45 per share, in 2022. Co-Diagnostics ended the year with $58.5 million in cash, cash equivalents, and marketable securities. 

COLA said this week that the Centers for Medicare & Medicaid Services has renewed its deeming approval for six years under the Clinical Laboratory Improvement Amendments of 1988. The nonprofit organization is approved to continue accrediting laboratories as CLIA-compliant through March 6, 2030, according to a Federal Register notice. COLA noted that it has secured approval to accredit CLIA-regulated specialties and subspecialties of microbiology, diagnostic immunology, chemistry, hematology, immunohematology, and pathology. The organization first received deeming authority from CMS in 1993. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.