ANN ARBOR, Mich. — ENDRA Life Sciences Inc. reported first-quarter financial results and said it continues to advance clinical and regulatory work for its TAEUS Liver device, while also reviewing strategic alternatives.
The company, which is developing thermoacoustic biomarker imaging technology for early detection and monitoring of steatotic liver disease, said its board began a process in March to evaluate strategic alternatives aimed at maximizing shareholder value. ENDRA said it has not set a timetable for completing the review and will continue operating initiatives during the process.
ENDRA also highlighted recent clinical validation data for TAEUS Liver, including multi-site results announced in May showing strong agreement with MRI-PDFF, high reproducibility and consistent performance across operators, sites and patient populations.
The analysis included 64 patients across U.S. and Canadian sites and showed a correlation to MRI-PDFF of r=0.90. ENDRA said the device also demonstrated diagnostic accuracy with area under the receiver operating characteristic values ranging from 0.95 to 0.99 at key thresholds, reproducibility with an intraclass correlation coefficient of 0.89 and no meaningful dependence on body mass index or body habitus.
In February, ENDRA reported results from another study showing repeatability and reproducibility for TAEUS Liver. That study involved 14 subjects and 56 unique measurements, with the device achieving an intraclass correlation coefficient of 0.89 using independent operators.
“During the first quarter, we continued to strengthen the clinical foundation for TAEUS Liver while maintaining disciplined operational execution,” said Alexander Tokman, CEO of ENDRA Life Sciences. “The recently announced multi-site validation data demonstrated strong agreement with MRI-PDFF across operators and patient populations. These data reinforce our belief that TAEUS Liver has the potential to deliver a practical, point-of-care solution for the large and growing population affected by steatotic liver disease. We remain focused on advancing our regulatory and commercialization strategy while managing our resources carefully.”
For the quarter ended March 31, ENDRA used $1.1 million in operations, down from $1.3 million in the same period last year. Total operating expenses were $2.2 million, compared with $1.5 million a year earlier.
The company said the increase reflected a $491,000 rise in non-cash stock-compensation expense and a $302,000 increase in long-term prepaid expenses associated with clinical learnings related to the TAEUS Liver device.
ENDRA reported a first-quarter net loss of $1.3 million, compared with a net loss of $1 million in the prior-year period.
As of March 31, the company had about $356,000 in cash and cash equivalents and about $2.4 million in its digital asset treasury.
TAEUS is being developed to assess tissue fat content and monitor tissue ablation during minimally invasive procedures at the point of care. ENDRA’s initial focus is measuring fat in the liver to help assess and monitor steatotic liver disease and metabolic dysfunction-associated steatohepatitis.
