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Update Regarding Forward Guidance

24 Sep 2025 14:00

RNS Number : 6757A
Renalytix PLC
24 September 2025
 

 

Renalytix plc

("Renalytix" or the "Company")

 

Update Regarding Forward Guidance

 

LONDON and NEW YORK, 24 September 2025 - Renalytix plc (LSE: RENX) a precision medicine company with kidneyintelX.dkd, the only FDA-approved and Medicare reimbursed prognostic test to support early-stage risk assessment in chronic kidney disease, provides a further comment regarding revenue guidance following the Company's announcement dated 23 September 2025.

 

The Company would like to clarify that the forward revenue guidance provided does not include full consideration of the implications of its recently announced collaboration with Tempus AI, Inc. ("Tempus"). As it is too early to predict revenue contributions from this new relationship with Tempus, the Company expects to provide shareholders with updates in due course.

 

For further information, please contact:

 

Renalytix Plc

James McCullough, CEO

 

www.renalytix.com

Via Walbrook PR

SP Angel Corporate Finance LLP (Nominated Adviser and Joint Broker)

Jeff Keating / David Hignell (Corporate Finance)

Vadim Alexandre (Corporate Broking)

 

Tel: 0203 470 0470

 

Oberon Capital (Sole Bookrunner and Joint Broker)

Mike Seabrook / Nick Lovering / Aimee McCusker

 

Tel: 020 3179 5300

 

Walbrook PR Limited

Paul McManus / Alice Woodings

Tel: 020 7933 8780 or renalytix@walbrookpr.com

Mob: 07980 541 893 / 07407 804 654

 

 

The person responsible for making this Announcement on behalf of the Company is

James McCullogh, Chief Executive Officer.

 

 

About Renalytix (www.renalytix.com)

Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes. Renalytix has received FDA approval and Medicare reimbursement for kidneyintelX.dkd which is now offered commercially in the United States.

 

Unrecognized and uncontrolled kidney disease remains one of the largest barriers to controlling cost and suffering in the United States and the United Kingdom's medical system, affecting over 14 million and 8 million people, respectively. After five years of development and clinical validation, kidneyintelX.dkd is the only FDA-approved and Medicare reimbursed prognostic tool capable of understanding a patient's risk with kidney disease early where treatment has maximal effect. kidneyintelX.dkd is now being deployed across large physician group practices and health systems in select regions of the United States.

 

The over 15,000 patients that have been tested by kidneyintelX.dkd have produced a substantial body of real-world performance data. In patient populations where kidneyintelX.dkd has been deployed, a demonstrated and significant increase in diagnosis, prognosis, and treatment rates have been recorded. kidneyintelX.dkd now has full reimbursement established by Medicare, the largest insurance payer in the United States, at $950 per reportable result. kidneyintelX.dkd is also recommended for use in the international chronic kidney disease clinical guidelines (KDIGO).

 

KidneyIntelX is based on technology developed by Mount Sinai faculty and licensed to Renalytix AI, Inc. Mount Sinai faculty members are co-founders and equity owners in the Company. In addition, the Icahn School of Medicine at Mount Sinai has equity ownership in Renalytix. For information about the kidneyintelX,dkd test, visit kidneyintelx.com.

 

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Date   Source Headline
28th Sep 20237:00 amRNSRenalytix Reports Full Year Fiscal 2023 Results
25th Sep 20237:00 amRNSNotice of Results
22nd Sep 20237:00 amRNSPayer coverage expansion of KidneyIntelX
7th Sep 20237:00 amRNSAppointment of Chief Business Officer
21st Aug 20237:00 amRNSBusiness Update
3rd Aug 20239:10 amRNSRSU vesting for employees
3rd Aug 20237:00 amRNSFormation of Clinical Advisory Board
21st Jul 20237:00 amRNSVector Pharma Middle East Distribution Agreement
17th Jul 20231:43 pmRNSIssue of Shares - Replacement
17th Jul 20237:00 amRNSIssue of Shares
7th Jul 20237:00 amRNSKidneyIntelX evidence presented at ADA
6th Jul 20235:38 pmRNSGrant of Share Options
3rd Jul 20237:00 amRNSDirectorate Change
30th Jun 20237:00 amRNSFDA Approves KidneyIntelX.dkd™
15th Jun 20237:00 amRNSPresentation of Scientific Data
9th Jun 20237:00 amRNSFinancial Results for Q3 of Fiscal Year 2023
8th Jun 20233:30 pmRNSResult of General Meeting
5th Jun 20237:00 amRNSNotice of Q3 Results
25th May 20237:00 amRNSEVERSANA® partnership for KidneyIntelX
22nd May 20237:00 amRNSExpansion of insurance coverage for KidneyIntelX
11th May 20237:00 amRNSNotice of GM and Posting of Circular
19th Apr 20237:00 amRNSReal-World Evidence Shows KidneyIntelX™ Utility
12th Apr 20237:00 amRNSPositive Data Release at NKF Conference
30th Mar 20237:00 amRNSHalf-year Report
27th Mar 202312:50 pmRNSBusiness Update - Replacement
27th Mar 20237:00 amRNSBusiness Update
22nd Mar 20237:00 amRNSNotice of Results
21st Mar 20232:05 pmRNSSecond Price Monitoring Extn
21st Mar 20232:00 pmRNSPrice Monitoring Extension
21st Mar 20237:00 amRNSUpdate on FDA De Novo Authorization Process
13th Mar 20237:00 amRNSStatement re. Silicon Valley Bank
7th Mar 20237:00 amRNSIssue of Shares
10th Feb 20233:13 pmRNSHolding(s) in Company
10th Feb 20232:01 pmRNSDirector/PDMR Shareholding
9th Feb 20237:00 amRNSRENX to Participate in the BTIG MedTech Conference
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26th Jan 20237:00 amRNSRenalytix and Partners Awarded $10 Million Grant
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9th Jan 202311:00 amRNSPrice Monitoring Extension
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19th Dec 202212:01 pmRNSResult of AGM
1st Dec 20227:00 amRNSClinical utility study data: further highlights
30th Nov 20227:00 amRNSResults for First Quarter of Fiscal Year 2023
29th Nov 20227:00 amRNSPublication of new real world evidence
22nd Nov 20227:00 amRNSNotice of Q1 FY23 Results
10th Nov 20227:00 amRNSPublication of Annual Report 2022 & Notice of AGM
9th Nov 20224:35 pmRNSPrice Monitoring Extension
3rd Nov 20227:00 amRNSRENX to Present at Stifel Healthcare Conference
31st Oct 20224:41 pmRNSSecond Price Monitoring Extn
31st Oct 20224:36 pmRNSPrice Monitoring Extension

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