Renalytix plc

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K for the year ended June 30, 2024 (this “Annual Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “goal,” “target,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements and opinions contained in this Annual Report are based upon information available to us as of the date of this Annual Report and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements include statements about:

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the ability to execute our plans for commercialization of KidneyIntelX;

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the timing and plans for regulatory filings and decisions;

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our plans to maintain regulatory approval of kidneyintelX.dkd and to further obtain and maintain regulatory approvals for other products from our KidneyIntelX platform;

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the potential benefits of KidneyIntelX;

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the market opportunities for KidneyIntelX and our ability to maximize those opportunities;

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our business strategies and goals;

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our ability and plans to establish and maintain partnerships and the projections of future test volume related to those partnerships;

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our ability and plans to drive adoption of KidneyIntelX and integrate KidneyIntelX into clinical workflow;

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estimates of our sales, revenue, expenses and capital requirements and our need for and ability to obtain additional financing;

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third-party payor reimbursement and coverage decisions;

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our expectations regarding our ability to obtain and maintain intellectual property protection for our diagnostic products and our ability to operate our business without infringing on the intellectual property rights of others;

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our expectations regarding regulatory classification of KidneyIntelX, as well as the regulatory response to the marketing and promotion of KidneyIntelX;

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the impact of guidelines and recommendations published by various organizations, including KDIGO 2023 Clinical Practice Guideline for Evaluation and Management of Chronic Kidney Disease, on the use of our products;

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our expectations regarding developments relating to our competitors;

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the potential for breaches of data privacy, or disruptions in our information technology systems;

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global economic trends, competition and geopolitical risks, including impacts from the ongoing conflict between Russia and Ukraine and the related sanctions and other measures, tensions across the Middle East, changes in the rates of investment or economic growth in key markets we serve, or an escalation of sanctions, tariffs or other trade tensions between the U.S. and China or other countries, and related impacts on our operations and strategies;

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risks involved in our operations such as supply chain issues, disruption of markets, changes in import and export laws, environmental regulations, currency restrictions and local currency exchange rate fluctuations

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our ability to complete the previously announced fundraising through a placing, a subscription and a retail offer of new ordinary shares to new and existing institutional and other investors;

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the transition of the listing of our American Depositary Shares from The Nasdaq Stock Market LLC to its quotation on The OTCQX Market, including any assurance that a market for our American Depositary Shares will develop on The OTCQX Market;

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our continuing qualification as a reporting company under the Securities Exchange Act of 1934 rather than as a “foreign private issuer” under U.S. federal securities laws;

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the sufficiency of our existing cash, cash equivalents and short-term investments to fund our operations and capital expenditure requirements; and

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risks detailed under the caption “Risk Factors” in this Annual Report and in our other reports filed with the U.S. Securities and Exchange Commission (“SEC”), from time to time hereafter.

You should refer to the sections of this Annual Report titled “Item 1A. Risk Factors” and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Forward-looking statements speak only as of the date on which such statements are made. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law, applicable regulations or the rules of the Nasdaq Stock Market LLC.

You should read this Annual Report, the documents that we reference in this Annual Report and the documents we have filed as exhibits to this Annual Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

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PART I