NEW YORK – Renalytix reported on Thursday $1.5 million in revenues for its full fiscal year 2021, up from none in fiscal 2020.
Among the highlights for the 12 months ended June 30, the London-based company, formerly called Renalytix AI, launched its KidneyIntelX blood-based assay for acute and chronic kidney disease detection in the second half of the fiscal year. Renalytix CEO and interim Chairman James McCullough said in a statement that the company is still waiting on a US Food and Drug Administration review of its de novo submission for full clearance of KidneyIntelX.
"While we will continue to decline to forecast projecting a definitive timeline for de novo marketing authorization, we are confident that KidneyIntelX will receive FDA de novo marketing authorization given interactive dialogue and data requirements to date and that fiscal 2022 commercial objectives are on track," he said.
Meanwhile, in April, Renalytix announced that the US government's General Services Administration granted it a 10-year Governmentwide Acquisition Contract (GWAC) that enables testing services using its KidneyIntelX early-stage kidney disease test. The contract covers laboratory testing services that can be provided by more than 140 federal departments, agencies, and affiliates.
The firm also completed the spin-out of Verici Dx, previously FractalDx, during FY 2021.
For fiscal 2021, Renalytix reported a net loss of $35.4 million, or $.49 per share, compared to a net loss of $9.8 million, or $.17 per share, in fiscal 2020.
Its R&D expenses more than doubled year over year to $10.0 million from $4.6 million, while its general and administrative expenses tripled during fiscal 2021 to $23.5 million from $5.8 million for the year ended June 30, 2020.
Renalytix had $65.1 million in cash and equivalents as of June 30.
Renalytix shares gained $1.45 on Thursday trading on the Nasdaq to close at $27.40.