UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39387 Renalytix plc (Exact name of Registrant as specified in its Charter) England and Wales Not Applicable (State or other j ...

Financial Data and Key Metrics - Revenue for Q1 FY2024 was $460,000, down from $970,000 in Q1 FY2023 [37] - Total tests conducted were 1,297, with 56% being billable, slightly higher than the previous quarter and year [37] - Operating expenses reduced to $8.8 million from $12 million in the prior year period, reflecting cost-cutting measures [40] - Net loss for Q1 FY2024 was $10.1 million or $0.11 per share, down from $12 million or $0.16 per share in Q1 FY2023 [42] - Cash balance as of September 30, 2023, was $13.9 million, with ongoing financing discussions to extend cash runway into 2026 [42] Business Line Data and Key Metrics - Payroll expenses reduced by over 35% and SG&A by more than 30% year-over-year [2] - Approximately half of the employee base is now directly responsible for sales and revenue recognition [3] - Sales team size will be 14 starting in 2024, focusing on high diabetes density regions [14] - Targeting primary care physicians serving high concentrations of diabetic patients, with 40% likely having chronic kidney disease [15] Market Data and Key Metrics - KidneyIntelX integration into Atrium Health expected to be finalized in December [4] - Anticipated hospital systems coming online with KidneyIntelX in 2024 [4] - Expected inclusion of KidneyIntelX in updated International Kidney guidelines [4] - Progress towards Medicare Local Coverage Determination (LCD) with National Government Services [4] - Initiation of payment from a second Medicare contractor, First Coast Options, in October 2023 [5] Company Strategy and Industry Competition - Shift towards preventative medicine in the kidney space, increasing burden on primary care to identify at-risk patients [8] - Pursuing programs to validate KidneyIntelX technology drug response scores with Pharma industry players and partners [9] - Focus on sales and marketing, with resources realigned from development and regulatory activities [76] - KidneyIntelX positioned to change preventative medicine in the large and costly population health market [6] Management Commentary on Operating Environment and Future Outlook - Optimistic about short-term events in fiscal 2024 to spur testing growth [3] - Market shift towards preventative medicine in the kidney space, with new drugs adding promise but complicating treatment decisions [24] - Real-world evidence programs at Mount Sinai and Atrium Wake Forest starting to bear fruit, aiding broader reimbursement and clinician adoption [72] Other Important Information - FDA De Novo Marketing Authorization for KidneyIntelX on June 29 [6] - Publication of new KidneyIntelX outcomes data submitted for peer review [5] - Sales team retooling and recruitment focusing on direct primary care sales efforts [14] Q&A Session Summary Question: Sales team optimization and territories [46] - Sales team targeting New York, Texas, Florida, North and South Carolina, and Ohio [47] - Current sales team size is 10, with 4 new hires expected by year-end [47] Question: EVERSANA partnership status [49] - Partnership with EVERSANA remains active [49] Question: NGS payment suspension and resumption [50] - Payment suspended during LCD review process, resumed in November 2023 [51] Question: First Coast LCD process and timing [57] - First Coast paying claims without requiring an LCD, meeting with medical directors in Q1 2024 to discuss future LCD necessity [58] Question: National Coverage Determination (NCD) [59] - Preference for diagnostic tests to be covered through LCD process, but NCD considered for tests with national Medicare policy implications [59] Question: Atrium Health integration and reimbursement [62] - Atrium Health integration expected to be completed in December, with commercial testing starting shortly thereafter [66] - Reimbursement at Medicare CLFS published price of $950 [67] Question: Sales growth outlook [74] - Focus on demonstrating commercial proof of concept in key markets, with sales team fully operational by March 2024 [76] Question: Fundraising and cash burn [80] - Targeting funding to extend cash runway into 2026, with cash burn expected to reduce to $3-5 million per quarter by end of FY2024 and $1-2 million by end of FY2026 [83] Question: Clin-Risk competitive threat [86] - Clin-Risk is a population-based risk score, differing from KidneyIntelX's in-vitro diagnostic approach [94] - KidneyIntelX captures patient biology through blood biomarkers, validated by FDA, and has broad-based reimbursement [96] Question: Cost reduction timing [93] - Cost reductions in process, with 30% reduction in SG&A expected by Q1 FY2025, evidence seen in immediate quarters ahead [113] Question: Pricing of billable tests [114] - Mount Sinai transitioned to full commercial reimbursement model, impacting average pricing due to some tests not being paid [115]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q England and Wales Not Applicable (State or other jurisdiction of incorporation or organization) Finsgate 5-7 Cranwood Street London, United Kingdom EC1V 9EE (Address of principal executive offices) (Zip Code) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITI ...

Financial Data and Key Metrics - Total revenue for fiscal year 2023 was $3.4 million, up 15% from fiscal 2022 [35] - Fourth quarter revenue was $520,000, compared to $830,000 in the prior year's fourth quarter [35] - Operating expenses for the fourth quarter were $9.8 million, down from $13.2 million in the prior year period [37] - Net loss for the fourth quarter was $11.1 million or $0.11 per share, compared to a net loss of $5.2 million or $0.07 per share in the prior year's fourth quarter [38] - Net cash used in operating activities for the year ended June 30 was $33.4 million, down 27% from $45.9 million in the prior fiscal year [39] - The company ended the fourth quarter with approximately $24.7 million in cash [39] Business Line Data and Key Metrics - KidneyIntelX achieved FDA de novo marketing authorization and was included in the draft KDIGO guidelines for 2023 [10] - The company aims for 1% US market penetration over the next three years, targeting 14 million adults with diabetes and kidney disease [11] - KidneyIntelX is priced at $950 or greater, with contracts in place with major insurance providers including Blue Cross Blue Shield, Medicare, and Medicaid [12][19] - The company is expanding its direct-to-physician sales force in key US regions with high rates of diabetes and kidney disease [29] Market Data and Key Metrics - The company has secured insurance coverage agreements with Blue Cross Blue Shield of Texas and Parkland Community Health Plan, covering millions of lives [19][32] - International opportunities are promising, particularly given the global growth in diabetes [12] - The company is focusing on regions with high rates of diabetes, kidney disease, and insurance coverage for KidneyIntelX [25] Company Strategy and Industry Competition - The company is reducing its quarterly cash burn rate, with reductions expected to become apparent in the second half of fiscal 2024 [13] - KidneyIntelX is positioned as the only FDA-authorized, machine learning-enabled prognostic tool for chronic kidney disease [14][15] - The company is exploring non-dilutive funding sources, including strategic partnerships and international licensing opportunities [13] - KidneyIntelX has demonstrated improved outcomes in diabetes and kidney disease, with real-world evidence showing clinical benefits [30] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the commercial prospects of KidneyIntelX, citing FDA authorization, reimbursement milestones, and inclusion in clinical guidelines [10][11] - The company is focused on expanding hospital system partnerships and insurance coverage to drive adoption [11][19] - Management expects to see increased testing volumes and revenue growth in fiscal 2024, particularly with the launch of the FDA-cleared version of KidneyIntelX [36][62] Other Important Information - The company filed an S-3 shelf registration statement to provide flexibility in sourcing capital [17] - KidneyIntelX has been integrated into major health systems like Mount Sinai and is being deployed in Wake Forest Atrium through Epic [43][47] - The company is pursuing Medicare coverage determination for KidneyIntelX, with expectations of achieving local or national coverage by early 2024 [53][65] Q&A Session Summary Question: When will the FDA-cleared version of KidneyIntelX be launched? - The FDA-cleared version is expected to launch in the March quarter of 2024, pending Medicare payment establishment and regulatory language updates [62][65] Question: What is the target market penetration for KidneyIntelX? - The company targets 1% penetration of the 14 million FDA-authorized use population over the next three years [51] Question: What are the expected cost reductions? - The company has already reduced operating expenses by $11 million year-over-year and is targeting further single-digit million reductions [88] Question: What is the status of the KDIGO guidelines inclusion? - The company expects KidneyIntelX to be included in the final KDIGO guidelines by the end of 2023 [66] Question: What is the outlook for test volume growth? - Test volumes are expected to grow, particularly with the FDA-cleared version launch and expansion in key regions [96]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 OR c☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39387 Renalytix plc (Exact name of Registrant as specified in its Charter) England and Wales Not Applicable (State or other jurisdiction ...

Renalytix plc (NASDAQ:RNLX) Q3 2023 Results Conference Call June 9, 2023 8:30 AM ET Company Participants Peter DeNardo - CapComm Partners James McCullough - CEO Tom McLain - President James Sterling - CFO Conference Call Participants Dan Arias - Stifel Chait G. - H.C. Wainwright Mark Massaro - BTIG Randy Baron - Pinnacle Operator Good morning, and welcome to the Renalytix Conference Call to Review Third Quarter Fiscal Year 2023 Financial Results. At this time, all participants are in a listen-only mode. We ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of report: June 9, 2023 Commission File Number: 001-39387 Renalytix plc (Translation of registrant's name into English) Finsgate 5-7 Cranwood Street London EC1V 9EE United Kingdom (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Fo ...

Yes, hi Jens. Interestingly, I think both of your questions are somewhat linked, and that while there is a lot of research going on in terms of how data and genetics can be used to generate insights into chronic kidney disease and other chronic conditions, they're very much at a population level of screening and early risk prediction in undiagnosed patients, which is somewhat different to the spectrum in which we operate in. And it's also largely based on discovery at discovery levels for sub phenotypes or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of report: March 30, 2023 Commission File Number: 001-39387 Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐ INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K On March 30, 2023 Renalytix plc issued a press release regarding its financial res ...

Exhibit 99.1 Renalytix plc Annual Report and Financial Statements FOR THE YEAR ENDED 30 JUNE 2022 | Renalytix plc Annual Report and Financial Statements 1 Index | STRATEGIC REPORT | 3-21 | | --- | --- | | Chairman & CEO's Joint Statement | 3 | | Company Overview | 8 | | Operational and Financial Highlights | 9 | | Product Overview and Strategy | 11 | | Financial Review | 13 | | Risk Management Approach | 15 | | Section 172 Statement | 19 | | Corporate Social Responsibility Review | 21 | | CORPORATE GOVERNAN ...