NEW YORK — Renalytix on Tuesday reported $482,000 in revenues for its fiscal first quarter of 2022 versus no revenues in the year-ago period.
The revenues for the three-month period ended Sept. 30 were derived primarily from testing services provided to Mount Sinai with the UK-based company's KidneyIntelX blood-based assay for acute and chronic kidney disease detection, which uses machine learning to analyze predictive biomarkers with patient health data.
In September, Mount Sinai and Renalytix scaled up the KidneyIntelX program to a targeted run rate of 300 tests per week with testing fully covered at $950 per test by the health system. Renalytix said that it expects 6,000 tests to be completed by the end of its fiscal year 2022.
Renalytix said that live testing under similar programs at Wake Forest Baptist Health and the University of Utah are set to begin this month. The company also recently signed an agreement to integrate the KidneyIntelX platform at St. Joseph's Health to improve kidney health in type II diabetes and early-stage chronic kidney disease patients.
Renalytix's net loss in fiscal Q1 rose to $10.1 million, or $.14 per share, from $7.6 million, or $.10 per share, a year earlier.
Fiscal Q1 R&D spending jumped 135 percent to $4.0 million from $1.7 million year over year, largely due to professional fees associated with KidneyIntelX clinical utilities studies at Mount Sinai, Wake Forest, and the University of Utah.
General and administrative costs in the quarter nearly doubled to $8.1 million from $4.1 million, mainly due to expenses related to increased headcount at the company, as well as consulting and professional fees.
At the end of September, Renalytix had cash and cash equivalents totaling $54.3 million.
Looking ahead, Renalytix said that it continues to wait for the US Food and Drug Administration to review its application for de novo marketing authorization of KidneyIntelX, which was submitted in August 2020. Staffing issues and SARS-CoV-2 pandemic-related issues have prevented the agency from meeting its 150-day de novo review goal, the company said, adding that it is not providing an expected timeline for when it may receive authorization.
Shares of Renalytix were up 2 percent at $15.34 in Tuesday morning trade on the Nasdaq.