Renalytix (OTC: RNLXY) is a clinical-stage diagnostics company focused on kidney disease risk assessment. Its primary product is KidneyIntelX, a diagnostic test designed to evaluate kidney disease progression risk and clinical utility across short, intermediate, and long-term patient management settings. The company has not yet reached commercial-scale revenue and carries a going concern qualification in its 10-K filed September 30, 2024, with the auditors noting substantial doubt about its ability to continue operations. In September 2024, the company announced a committed equity financing of approximately £11 million from existing and new investors, expected to close in tranches beginning October 9, 2024, and projected to fund operations for at least 12 months. As of the fiscal year ended June 30, 2024, the company was burning approximately $0.75 million or less per month in cash, following a Nasdaq delisting and re-qualification as a foreign private issuer. The company is incorporated outside the United States and files with the SEC as a foreign private issuer.

Revenue model

The filing excerpts do not disclose specific revenue figures, pricing model, or commercial revenue streams for the fiscal year ended June 30, 2024. The company has funded operations primarily through equity issuances, including $20.3 million from ordinary share issuances in FY2023, and convertible notes.

Products and services

KidneyIntelX: a diagnostic test for kidney disease progression risk assessment, evaluated across multiple clinical settings including short, intermediate, and long-term use. The company also references intellectual property related to kidney transplant rejection risk and kidney disease diagnostic accuracy.

Customers and end markets

The filing references clinical settings as the deployment environment for KidneyIntelX, indicating healthcare providers and health systems as the target customer base. No specific customer names, counts, or revenue concentration data are disclosed in the excerpts.

Value-chain role

Developer and commercializer of proprietary kidney disease diagnostic tests. Relies on third-party service providers for cloud infrastructure, data center facilities, and other critical operations. Subject to regulatory approval or clearance processes for its diagnostic products.

Geographic exposure

Incorporated outside the United States and qualifies as a foreign private issuer. Subject to data privacy regulations across multiple jurisdictions including the EU GDPR, UK GDPR, Brazil LGPD, and China PIPL, indicating international operational exposure. Equity financing commitment denominated in British pounds sterling as of September 30, 2024.

Source: SEC 10-K, filed 2024-09-30

Industry: Services-Medical Laboratories Peers: Onemednet Corp