Renalytix Reports Financial Results for Third Quarter of Fiscal Year 2022

June 30, 2022

LONDON and SALT LAKE CITY, June 30, 2022 (GLOBE NEWSWIRE) — Renalytix plc (NASDAQ: RNLX) (LSE: RENX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, today reported financial results for the quarter ended March 31, 2022.

Recent Highlights (including post period events)

• Successful completion of $30.0 million financing package ($26.8 million gross proceeds)
• Multiple data presentations at the American Diabetes Association (ADA) 82nd Scientific Sessions® meeting
• Focused on the value of KidneyIntelX testing in patients with type 2 diabetes (T2D) and early-stage chronic kidney disease (CKD):

• • KidneyIntelX ability to assess risk of heart failure hospitalization and death in large international diabetic kidney disease patient cohort (also published in Kidney360)
  • KidneyIntelX testing in 1,112 adult diabetic kidney disease (DKD) patients at Mount Sinai Health System demonstrated utility in driving guideline appropriate use of therapies, including SGLT-2 inhibitors and RAAS inhibitor use, and timely consultation to specialists in high-risk patients.

• Continued KidneyIntelX testing volume growth
• Over 3,000 KidneyIntelX risk scores generated for Mount Sinai Health System patients and over 300 at Wake Forest Baptist Health
• 33 state Medicaid programs contracted to date
• New coverage for KidneyIntelX by the largest private payer in Illinois with 8.1 million members
• KidneyIntelX coverage from the largest independent provider network in North Carolina, South Carolina and Virginia, with over 100,000 health care providers in-network

Third Quarter 2022 Financial Results
During the three months ended March 31, 2022, the Company recognized $0.8 million of revenue (Q3 FY21: $0.6 million). Cost of revenue for the three months ended March 31, 2022 was $0.7 million (Q3 FY21: $0.2 million).

Operating expense for the three months ended March 31, 2022 was $14.7 million compared to $8.5 million during the prior year period.

Within operating expenses, research and development expenses were $3.9 million for the three months ended March 31, 2022, an increase of $0.8 million, from $3.1 million for the three months ended March 31, 2021. The increase was driven by employee related expenses, lab supplies and professional fees associated with the utility studies at Mount Sinai, Wake Forest and University of Utah.

General and administrative expenses were $10.8 million for the three months ended March 31, 2022, increasing by $5.3 million from $5.5 million for the three months ended March 31, 2021. The increase was primarily due to a $4.3 million increase in compensation, reimbursable expenses and related benefits, including share-based payments, due to increased headcount, a $0.7 million increase in consulting and professional fees including marketing expense, a $0.2 million increase in computers, software and IT costs, and a $0.1 million increase in other operating expenses.

Net loss attributable to ordinary shareholders was $14.7 million for the three months ended March 31, 2022 compared to $8.8 million for the prior year period.

Cash and cash equivalents totaled $32.4 million as of March 31, 2022. This was prior to the completion of the $26.8 million (gross) financing package, further details of which were announced on March 31, 2022, which completed post-period end on April 8, 2022.

The Company also intends to file with the Securities and Exchange Commission a shelf registration statement on Form F-3 pursuant to which the Company may offer and sell up to $300 million of its ordinary shares, ordinary shares in the form of ADSs, debt securities and warrants, including the intention to enter into a sales agreement with a sales agent pursuant to which the Company may sell, from time to time, at its option, up to $50 million of ADSs through the sales agent in “at the market” transactions on Nasdaq.

The Company will host a corresponding conference call and live webcast today to discuss the financial results and key topics including business strategy, partnerships and regulatory and reimbursement processes, at 8:30 a.m. (ET) / 1:30 p.m. (GMT).

Conference Call Details:
US/Canada Participant Toll-Free Dial-In Number: (833) 614-1551
US/Canada Participant International Dial-In Number: (914) 987-7290
United Kingdom International Dial-In Number: 0800 0288 438
United Kingdom Local Dial-In Number: 0203 1070 289
Conference ID: 1546327

Webcast Registration link: https://edge.media-server.com/mmc/p/y3zwhkuk

For further information, please contact:

About Renalytix
Renalytix (LSE: RENX) (NASDAQ: RNLX) is the global founder and leader in the new field of bioprognosis™ for kidney health. The company has engineered a new solution that enables early-stage chronic kidney disease progression risk assessment. The Company’s lead product, KidneyIntelX™, has been granted Breakthrough Designation by the U.S. Food and Drug Administration and is designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery (visit www.kidneyintelx.com). For more information, visit www.renalytix.com.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the commercial prospects of KidneyIntelX, including whether KidneyIntelX will be successfully adopted by physicians and distributed and marketed, the rate of testing with KidneyIntelX in health care systems, expectations and timing of announcement of real-world testing evidence, the potential for KidneyIntelX to be approved for additional indications, our expectations regarding regulatory and reimbursement decisions, the ability of KidneyIntelX to curtail costs of chronic and end-stage kidney disease, optimize care delivery and improve patient outcomes, and our expectations and guidance related to partnerships, testing volumes and revenue for future periods. Words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “seeks,” and similar expressions are intended to identify forward-looking statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving and potential acceptance, utility and clinical practice remains uncertain; we have only recently commercially launched KidneyIntelX; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our annual report on Form 20-F filed with the SEC on October 21, 2021, and other filings we make with the SEC from time to time. All information in this press release is as of the date of the release, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Renalytix Reports Financial Results for Third Quarter of Fiscal Year 2022