Renalytix AI Posts Interim Loss Ahead Of KidneyIntelX 2019 Launch – Morningstar

LONDON (Alliance News) – Renalytix AI PLC on Monday posted a loss for the first half of its financial year due to administrative expenses as it prepared to launch its kidney diagnostic product in 2019.

Shares in Renalytix were up 5.5% at 145.00 pence each on Monday.

For the six months to December 31, the company posted a pretax loss of USD2.88 million, of which GBP2.86 million was a result of administrative expenses, with the remaining USD20,000 attributed to finance costs.

Renalytix, which started trading on London’s AIM market on November 6, is not yet revenue producing.

The goal of Renalytix is to use artificial intelligence to make kidney disease diagnosis more precise. The company raised USD26.8 million through its initial public offering, and is using the funds to support both its artificial intelligence technology platform and its KidneyIntelX diagnostic product.

At present, KidneyIntelX is undergoing a clinical validation trial using 5,000 patient samples, prior to commercial launch in the US in the second half of the 2019 calendar year.

Moreover, Renalytix has also submitted a request to the US Food & Drug Administration for a breakthrough device designation for KidneyIntelX.

Alongside this, the company has also submitted a request to the US Centers for Medicare & Medicaid Services for reimbursement review. This would mean that Medicare and Medicaid, which provide government-backed health cover to certain groups in America, would cover KidneyIntelX.

The company is assessing its plans for FractalDx, a diagnostic tool that can identify kidney transplant rejection and assess the amount of immunosuppressive medication needed to prevent rejection.

Non-Executive Chair Julian Baines said: “We are pleased with the rate of progress that we have made since IPO and are confident that we will continue to deliver key operational milestones in accordance with our plans. Our immediate strategy is focused on product development, regulatory authority engagement and the pathway to payer reimbursement in the United States, with each such milestone having the potential to create significant value for the company.”

“Our lead programme for detection of fast-progressing kidney disease, KidneyIntelX, is expected to launch in the second half of this calendar year and has the potential to address one of the largest unmet medical needs globally, estimated to affect over 850 million people.”

By Anna Farley; annafarley@alliancenews.com

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