Announcement • Jun 30
Renalytix Publishes Real World Evidence Study Data For KidneyintelX.dkd Test Renalytix plc announced the publication of results in the peer-reviewed medical journal, Diabetes, Obesity and Metabolism, from its most comprehensive real-world evidence (RWE) study to date for the Company's FDA-approved kidneyintelX.dkd test. Spanning 2,470 patients with type 2 diabetes and early-stage chronic kidney disease (CKD) who were enrolled into the IRB-approved prospective study across two major U.S. health systems, Mount Sinai Health System in New York and Wake Forest/Atrium Health in North Carolina, reveals that kidneyintelX.dkd not only transforms how clinicians assess risk but changes the course of disease over a full two year period, a first for any kidney prognostic tool. The KidneyIntelX real-world evidence program has evolved from the six to 12 to 24-month time periods, demonstrating sustainable clinical improvements tied to how the test's risk stratification successfully informs guideline-directed medical treatment (GDMT). 6-Month RWE: Established that KidneyIntelX risk results changed clinician decision-making and GDMT in a real-world setting. 12-Month RWE: Confirmed that these changes in risk-stratified GDMT were associated with meaningful improvements in kidney, cardiac, and metabolic markers (eGFR slope, UACR, HbA1c, blood pressure). Just released 24-Month RWE data demonstrates that: (1) KidneyIntelX is a dynamic, longitudinal risk tool, not just a one-time test; (2) blood-based biomarkers strongly influence the changes in risk level, (3) robust independent prognostic performance in two contemporary care settings, and (4) significantly increased GDMT (e.g., SGLT2 inhibitors and GLP1 receptor agonists) use post-baseline risk assessment. Prior studies showed the KidneyIntelX test influenced clinical decisions and improved immediate markers of kidney health. The two-year analysis proves these improvements translate into real and lasting benefits for patients. 29% of patients who were retested moved into a lower risk category, accompanied by biomarker reductions. SGLT2 inhibitor use increased substantially across all risk groups over two years, reaching 56% in high-risk patients overall and soaring to 70% in high-risk patients at Mount Sinai. Combination SGLT2 inhibitor and GLP-1 receptor agonist therapy in high-risk patients nearly tripled, rising from 12% to 32% over the same period. Patients who started SGLT2i or GLP-1 RA therapies had nearly double the odds (OR 1.93) of achieving risk reduction - demonstrating a real-world link between treatment informed by kidneyintelX.dkd results and patient benefit. KidneyIntelX demonstrated powerful independent prognostic performance: patients designated as high risk at baseline were 10.4 times more likely to experience significant kidney function decline or kidney failure than low-risk patients, even after adjusting for standard clinical variables. No standard clinical combination - eGFR, UACR, HbA1c - has achieved risk separation of this magnitude. From baseline to 2 years, the rate of eGFR decline improved by 43%, UACR decreased by 23%, and HbA1c decreased by 7.6%, while systolic blood pressure remained stable across all risk groups. KidneyintelX.dkd is the only FDA-approved and Medicare-reimbursed prognostic tool capable of understanding a patient's risk with diabetic 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). Announcement • Feb 12
Renalytix Plc Provides Earnings Guidance for the Year 2026 Renalytix Plc provided earnings guidance for the year 2026. For the year, company expected revenues are now expected to be circa $4.0 Million (FY25 $3.0 Million). The sales pipeline that is currently being onboarded will significantly expand the EMR integrated testing footprint of kidneyintelX.dkd in 2026 and provide multiple opportunities with large healthcare systems in western and eastern United States. Announcement • Jan 12
Renalytix plc Completes Three Additional Health Care Provider Clinical Integrations in United States Renalytix plc with kidney IntelX.dkd announced that during the last quarter of 2025 it successfully completed three additional health care provider clinical integrations in the United States. Initial testing volumes have now commenced across all sites. The Company continues to expand its electronic health care integrated testing with one-click ordering for ease of physician use. The integrations were completed with Joseph P. Addabbo Family Health Center in New York, Central Florida Kidney Specialists in Florida and The Kidney Experts PLLC in Tennessee. All three sites are established regional kidney care providers and the integrations were implemented directly by Renalytix. These integrations enable the use of Renalytix's kidney disease testing solutions within each practice's existing clinical workflow. While each practice currently represents modest initial testing volumes, the Company anticipates growing utilisation over time as adoption expands across their respective patient populations. Renalytix continues to focus on disciplined expansion of its clinical footprint and expects to complete additional integrations with healthcare providers in early calendar year 2026. The Company believes this measured approach supports scalable growth in test utilisation, while maintaining efficient deployment of internal resources. The company continues to work closely with Tempus AI Inc. to advance electronic health record integrated testing and data collection with major US healthcare providers in alignment with its longer-term goal of data-driven kidney disease solutions. personnel from Tempus and Renalytix has been working closely together since this key collaboration was announced in September 2025, to target the healthcare customers integrated with Tempus that have large, costly populations of diabetes and kidney disease patients. The collaboration with Tempus will support the development of solutions to enable future expansion into additional clinical and geographic markets over time. The conference is attended by a broad range of healthcare and life sciences companies, including data and diagnostics partners such as Tempus. The Company looks forward to updating investors on progress, corporate development and trading in February 2026. Announcement • Nov 19
Renalytix plc Announces the Publication of Pivotal New Data in Diabetes Care Renalytix plc announced the publication of pivotal new data in Diabetes Care, the top-ranked global diabetes journal of the American Diabetes Association. The published manuscript, "Baseline Risk and Longitudinal Changes in kidney IntelX.dkd and Its Association with Kidney Outcomes in the CANVAS and CREDENCE Trials," was authored by leading nephrology and metabolism experts from the US, Europe, and Australia. The study evaluated 2,954 patients from the landmark CANVAS and CREDence trials--representing the full intended-use population for kidney IntelX.dkd. Improved CKD risk prediction: kidney IntelX.dkd significantly enhanced risk stratification across all KDIGO guidance categories, delivering more accurate assessment of CKD progression risk and potential kidney failure. Actionable treatment guidance: Among patients classified as moderate or high risk, those treated with frontline SGLT2 inhibitors showed a significant reduction in kidney IntelX.dkD risk levels at one year, with high-risk patients twice as likely to show risk improvement compared with untreated patients. The authors concluded that kidney IntelX.dkd, and its novel kidney biomarkers, enables clinicians to identify patients most likely to benefit from therapy, supporting personalized risk-based care and offering a powerful tool for future clinical trials. Across clinical trials, real-world deployment, and head-to-head performance comparisons, kidney IntelX.dkd continues to show consistent, incremental value as a core component of precision medicine in CKD. These results support its role as a transformative tool in integrated care management--ult ultimately driving significant improvements in patient and health outcomes. Announcement • Nov 06
Renalytix Plc, Annual General Meeting, Dec 09, 2025 Renalytix Plc, Annual General Meeting, Dec 09, 2025. Location: 6 stratton street mayfair, w1j 8ld, london United Kingdom Announcement • Sep 27
Renalytix Plc has completed a Follow-on Equity Offering in the amount of £0.8 million. Renalytix Plc has completed a Follow-on Equity Offering in the amount of £0.8 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 8,421,052
Price\Range: £0.095 Announcement • Sep 23
Renalytix Plc has filed a Follow-on Equity Offering in the amount of £0.5 million. Renalytix Plc has filed a Follow-on Equity Offering in the amount of £0.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 5,263,157
Price\Range: £0.095 Announcement • Jul 31
Renalytix Files Form 15 Renalytix Plc has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its American Depository Shares (each representing two shares of ordinary stock, nominal value £0.0025 per share) and Ordinary Shares, nominal value £0.0025 per share under the Securities Exchange Act of 1934, as amended. Announcement • Jun 19
Renalytix plc Announces New Pivotal Data Demonstrating How KidneyintelX.dkd Enhances Risk Assessment over Standard Clinical Measures Renalytix plc announced that new pivotal data demonstrating how kidney IntelX.dkd enhances risk assessment over standard clinical measures alone thereby enabling more efficient treatment allocation, was presented at the prestigious European Renal Association Congress 2025 held in Vienna on 4-7 June. The presentation titled " Evaluating KDIGO and Kidney IntelX.dkd for Risk Stratification in Diabetic Kidney Disease: Insights from CANVAS and CREDENCE" was selected as one of the highest scoring abstracts for presentation. The analysis included 2,954 subjects from the CANVAS and CREDence clinical trials who met the kidney IntelX.dkd intended use criteria and were randomized to treatment with SGLT2i or Placebo and followed for up to five years. The kidney IntelX.dkd risk level was assessed at baseline and at the one-year timepoint post randomization. Some of the key findings reported include: The kidney IntelX.dkD test reclassified 40% of patients to a different risk from baseline KDIGO risk levels category (e.g. from moderate to high/low, low to moderate, or high to moderate/low); Over the follow-up period, patients in the kidney IntelX.dkD high-risk level at baseline displayed a >20 times observed risk (after adjustment) compared to those classified as lowest risk by KDIGO - Treatment with SGLT2i reduced the kidney IntelX.dk d levels significantly after one year compared to those not treated, with almost a 20% between group difference in the changes observed - Patients who remained at high risk after one year had >4 times higher risk of events than those who were re-classified to moderate risk. The data shows that by targeting care to patients at highest risk of progression, a significant reduction in risk can be achieved in the short-term leading to improved outcomes for patients in the long-term. Announcement • May 22
Renalytix plc Announces First Use of KidneyIntelX in a Clinical Trial for New CKD Therapy Renalytix plc announced that a key milestone has been reached in the very first use of KidneyIntelX in a clinical trial, following the successful enrollment and treatment of the first patient to determine the safety and efficacy of a novel cell therapy for patients with Chronic Kidney Disease ("CKD"). Renalytix and AION Heathspan, Inc, a US-based clinical-stage biotech company dedicated to advancing regenerative medicine for acute and chronic degenerative diseases, are partnering in the use of KidneyIntelX as a precision medicine solution in the clinical development programme for AION Healthspan's REJUVXLTM (AION-301), including helping monitoring of therapeutic efficacy. This partnered programme represents the first instance where KidneyIntelX is incorporated into a clinical trial of a new therapy in CKD. Change in KidneyIntelX risk levels is included as an outcome measure in this first-in-human clinical trial. Under the terms of the agreement, Renalytix will be responsible for determining KidneyIntelX risk levels in subjects enrolled in the study and supporting analysis of the data in accordance with the clinical protocol. Renalytix is in a strong position to support pharmaceuticals companies looking to incorporate a precision medicine solution, like KidneyIntelX, into their clinical development and commercial programmes, activity which supports the increasing diversification of revenue streams. Announcement • Mar 19
Renalytix plc Reaffirms Revenue Guidance for the Fiscal Year 2025, 2026 and 2027 Renalytix Plc reaffirmed revenue guidance for the fiscal year 2025, 2026 and 2027. Forward guidance on expected revenue remains: For the fiscal year 2025, the company expected revenue of $3.2 million.
For the fiscal year 2026, the company expected revenue of $8.5 million.
For the fiscal year 2027, the company expected revenue of $17.5 million. Announcement • Mar 12
Renalytix Plc to Report First Half, 2025 Results on Mar 18, 2025 Renalytix Plc announced that they will report first half, 2025 results on Mar 18, 2025 Announcement • Dec 02
Renalytix Plc Appoints Robert Naylor as Non-Executive Director Renalytix Plc announced the appointment of Robert Naylor as Non-Executive Director with immediate effect. Robert has 29 years' experience in capital markets, specialising in both the life sciences and investment companies sectors. Robert is currently CEO and Co-Founder of Intuitive Investments Group plc, a London Stock Exchange Specialist Funds Segment investment company providing investors with exposure to fast growing technology and life sciences businesses. Robert is also Non-Executive Director of NIOX Group PLC,a company dedicated to improving asthma diagnosis and management, and PRS REIT plc, a FTSE 250 closed-ended real estate investment company which invests in high-quality, new build, family homes in the private rented sector. Previously, Robert was Chairman of Hipgnosis Songs Fund Limited, a FTSE 250 company, which was subject to a recommended cash offer by a newly-formed company indirectly wholly-owned by investment funds advised by affiliates of Blackstone Inc. Robert was Chairman of Round Hill Music Royalty Fund Limited and oversaw its sale to a company directly owned by Alchemy Copyrights, LLC, trading as Concord. Earlier in his career Robert held various positions within JP Morgan Asset Management Limited, Panmure Gordon (UK) Limited and Cenkos Securities plc. Robert is a qualified chartered accountant, having started his career with Ernst & Young in 1996. Announcement • Nov 27
Renalytix Plc, Annual General Meeting, Dec 19, 2024 Renalytix Plc, Annual General Meeting, Dec 19, 2024. Location: 6 stratton street, mayfair, w1j 8ld, london United Kingdom Announcement • Nov 20
Renalytix Plc Provides Revenue Guidance for Years 2025, 2026 and 2027 Renalytix Plc provided revenue guidance for years 2025, 2026 and 2027. For the fiscal year 2025, the company expects revenue of $3.2 million.
For the fiscal year 2026, the company expects revenue of $8.5 million.
For the fiscal year 2027, the company expects revenue of $17.5 million. Announcement • Nov 15
Renalytix Plc announced delayed 10-Q filing On 11/14/2024, Renalytix Plc announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Nov 05
Renalytix plc Announces Board Changes Renalytix plc announced the appointment of Julian Baines MBE as Executive Chairman after shareholders approved the resolution passed at the Company's General Meeting on 31 October 2024. Julian replaces Christopher Mills who will move to a Non-Executive Director role. Julian has significant experience in the life science industry and was the CEO of EKF Diagnostics Holdings Plc (EKF) and BBI Holdings plc. Julian rejoined the executive team at EKF as Executive Chairman in February 2023. Julian is also currently Non-Executive Chairman of Verici Dx plc. Before joining EKF, he undertook a management buyout at BBI in 2000, a flotation on AIM in 2004 and was responsible for selling the business to Alere Inc. (now part of Abbott Laboratories) in 2008 for c. £85 million. Julian was previously Non-Executive Chairman of Renalytix from March 2018 to June 2020. Julian Huw Baines (aged 60) has held the following directorship or partnerships in the past five years: Current directorships/partnerships: Verici Dx PLC, EKF Diagnostics Holdings PLC and J & K (Cardiff) Limited. Previous directorships/partnerships (last five years): Intuitive Investments Group PLC, Trellus Health PLC, EKF Molecular Diagnostics Limited, Quotient Diagnostics Limited, 360 Genomics Limited, EKF Diagnostics Limited and Renalytix PLC. Julian Baines was a director of BB Electronics Limited. Announcement • Nov 01
Renalytix plc Announces Step Down of Dan Levangie, Non-Executive Director from the Board Renalytix plc announced that Dan Levangie, Non-Executive Director has stepped down from the Board of Renalytix, effective immediately, following the General Meeting 31 October 2024. Announcement • Oct 08
Renalytix Plc(OTCPK:RNLX.Y) dropped from NASDAQ Composite Index Renalytix AI plc has been dropped from the NASDAQ Composite Index. Announcement • Aug 27
Nasdaq Grants Listing Extension to Renalytix Renalytix plc provided the following update in respect of its Nasdaq listing status. As previously announced on June 27, 2024, the Company disclosed that it had formally submitted an appeals hearing request to the Nasdaq Hearings Panel (the ‘Panel’), which request stayed the suspension of the Company's securities pending the Panel's decision regarding the continued listing status of Renalytix's American Depositary Shares (‘ADSs’) on The Nasdaq Global Market under the symbol ‘RNLX’. The appeals hearing on this matter was held on July 30, 2024. Following a review of the Company's operating and financing plans, on August 23, 2024 the Panel responded with their decision to grant the Company additional time to regain compliance. The Panel considered all information provided and granted the Company's request for an exception through October 25, 2024, at which time the Company must evidence compliance with a closing bid price of $1 or more per share, file public disclosure describing transactions undertaken by Renalytix to achieve compliance, and provide the Panel with income projections for the next 12 months. The Panel also agreed that the Company is better suited for The Nasdaq Capital Market at this time. With that and the Panel's decision to grant the exception, the Company's ADSs will transfer to the Nasdaq Capital Market effective at the open of trading on August 27, 2024. As a reminder, the Company confirms that it is in advanced discussions with key stakeholders of the business, who have indicated their support for management to achieve the Company's goals of the refreshed business plan, with focused expenditure and investment alongside reduced operating costs, and a suitable capital structure and funding. The Company will continue to assess options to maximize value for its shareholders and further updates will be made as appropriate. Announcement • Jun 29
Renalytix Submits Hearing Request to Nasdaq Hearings Panel in Regard to Staff Delisting Determination Renalytix Plc announced that it has formally submitted a hearing request to the Nasdaq Hearings Panel (the ‘Panel’), which request has now stayed the suspension of the Company's securities pending the Panel's decision. Throughout the hearings process, pending the Panel's decision, the Company's American Depositary Shares (‘ADSs’) will continue trading on The Nasdaq Global Market under the symbol ‘RNLX.’ At the Panel hearing, the Company intends to present a strategic plan to regain compliance with the applicable Nasdaq listing requirements. However, there can be no assurance that the Company's plan will be accepted by the Panel or that, if it is, the Company will be able to regain compliance with the applicable Nasdaq listing requirements. If the Company's ADSs are delisted, it could be more difficult to buy or sell the Company's ADSs or to obtain accurate quotations, and the price of the Company's ADSs could suffer a material decline. Delisting could also impair the Company's ability to raise capital. As previously disclosed, on June 25, 2024, the Company received written notice on June 21, 2024, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that it has been out of compliance with Nasdaq's minimum closing bid price requirement, as set forth in Nasdaq Listing Rule 5450(a)(1), for the Company's ADSs and the requirement to maintain a minimum market value of listed securities of $50,000,000 for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(b)(2)(A). Accordingly, the Company has submitted the Nasdaq hearing request, which has automatically stayed any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. In that regard, pursuant to the Nasdaq Listing Rules, the Panel has the authority to grant an extension not to exceed 180 days from the date of the Nasdaq delisting notice. Announcement • Jun 25
Renalytix Provides Non-Compliance Update As previously disclosed, on December 22, 2023, Renalytix plc (the ‘Company’) received two written notices (the ‘Notices’) from the Listing Qualifications Department of the Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that (i) because the closing bid price for the Company’s American Depositary Shares (‘ADSs’), each representing two ordinary shares, nominal value £0.0025 per share, was below $1.00 per ADS for at least 30 consecutive business days, the Company did not meet the $1.00 per ADS minimum bid price requirement of Nasdaq Listing Rule 5450(a)(1) the (‘Minimum Bid Price Requirement’) and (ii) it is not in compliance with the requirement to maintain a minimum market value of listed securities (the ‘MVLS’) of $50,000,000 for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(b)(2)(A) (the ‘MVLS Requirement’). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A) and Nasdaq Listing Rule 5810(c)(3)(C), the Company had a compliance period of 180 calendar days, or until June 19, 2024 (the ‘Compliance Period’), to regain compliance with the Minimum Bid Price Requirement and the MVLS Requirement. On June 21, 2024, the Company received written notice from Nasdaq notifying the Company that the Nasdaq staff has determined that the Company did not regain compliance within the Compliance Period. As a result, unless the Company requests an appeal of this determination before a Nasdaq Hearings Panel (the ‘Panel’) by June 28, 2024, trading of the Company's ADSs will be suspended at the opening of business on July 2, 2024, and a Form 25-NSE will be filed with the Securities and Exchange Commission (the ‘SEC’), which will remove the Company's securities from listing and registration on Nasdaq. The Company intends to submit an appeals hearing request to the Panel, which request will stay the suspension of the Company's securities and the filing of the Form 25-NSE pending the Panel's decision. At the Panel hearing, the Company intends to present a strategic plan to regain compliance with the applicable Nasdaq listing requirements. In the interim, the Company's ADSs will continue to trade on Nasdaq. There can be no assurance that the Company's plan will be accepted by the Panel or that, if it is, the Company will be able to regain compliance with the applicable Nasdaq listing requirements. If the Company's ADSs are delisted, it could be more difficult to buy or sell the Company's ADSs or to obtain accurate quotations, and the price of the Company's ADSs could suffer a material decline. Delisting could also impair the Company's ability to raise capital. Announcement • May 29
Renalytix Plc Announces Chief Financial Officer Changes Renalytix plc announced that O. James Sterling will step down from his role as Chief Financial Officer of the company as of 24 May 2024 and will remain at the company until 10 June 2024. The Board has appointed Joel R. Jung as Interim Chief Financial Officer, effective immediately while a handover period takes place. Previously, Mr. Jung served as Chief Financial Officer at Minerva Surgical Inc. from July 2020 to February 2024. Mr. Jung served as a financial consultant to several life sciences companies from October 2018 to July 2020. From October 2018 to June 2019, Mr. Jung held various positions at uBiome Inc., including as Chief Financial Officer from March 2019 to June 2019. Prior to that, Mr. Jung served as the Chief Financial Officer for four companies including Counsyl Inc., Bionano Genomics Inc., AgraQuest Inc., and Celera Corporation. Mr. Jung holds a B.S. Degree in Aeronautical Engineering from Purdue University and an M.B.A. from the Haas School of Business at the University of California, Berkeley. Announcement • May 10
Renalytix Plc to Report Q3, 2024 Results on May 15, 2024 Renalytix Plc announced that they will report Q3, 2024 results Pre-Market on May 15, 2024 Announcement • Apr 19
Renalytix plc Announces Executive Changes, Effective from April 30, 2024 Renalytix plc announced that Howard Doran, who has served as the Company's Chief Business Officer since September 2023, has been appointed as President, effective April 30, 2024. Thomas McLain, who has served as the Company's President since July 2019, is stepping down effective that date. Announcement • Apr 10
Renalytix Plc has filed a Follow-on Equity Offering in the amount of $1 million. Renalytix Plc has filed a Follow-on Equity Offering in the amount of $1 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 2,666,667
Price\Range: $0.375
Transaction Features: Registered Direct Offering Announcement • Mar 30
Renalytix Plc, Annual General Meeting, Apr 22, 2024 Renalytix Plc, Annual General Meeting, Apr 22, 2024, at 15:00 Coordinated Universal Time. Location: 6 Stratton Street Mayfair London W1J 8LD London United Kingdom Agenda: To consider That the Directors be and are hereby generally and unconditionally authorised pursuant to section 551; To consider That in substitution for any existing such authorities. Announcement • Mar 15
Renalytix plc's KidneyIntelX Included in Final KDIGO 2024 Clinical Guideline for Chronic Kidney Disease Renalytix plc announces that the KidneyIntelX In-Vitro Diagnostic test has been included in the final KDIGO (Kidney Disease Improving Global Outcomes) 2024 Clinical Practice Guideline [1] for the Evaluation and Management of Chronic Kidney Disease (CKD), published on March 13, 2024. In the release of the new guideline, timed to coincide with World Kidney Day on March 14, the KDIGO committee highlighted the role of risk prediction in guiding care for patients. In this context, KidneyIntelX is recommended for use as an externally validated tool for predicting disease progression in people with CKD stages G1-G3. The Guideline Work Group recognized that the progression of CKD can occur at all stages, and that in earlier stages of disease (G1–G3), understanding the risk of 40% decline in kidney function over a short term 5 years, as per the indicated use of KidneyIntelX, is mportant for guiding early intervention, particularly in people at intermediate or high risk for progression. Renalytix received FDA de-novo marketing authorization for kidneyintelX.dkd in June 2023 for use in assessment of the risk of progressive decline in kidney function in patients with CKD stages G1-G3 and Type 2 Diabetes. Subsequent to the release of the draft content of this updated guideline in July 2023, further evidence has been published from clinical utility and outcomes studies with a current enrollment of more than 9,000 patients with Type 2 Diabetes and CKD G1-G3. In January 2024, published outcomes data from an analysis of more than 2,500 patients with one year of follow-up demonstrated that providing clinicians access to KidneyIntelX risk assessment to inform care was associated with clinical actions that resulted in sustained reduction in eGFR decline, improved diabetes management and improved cardiovascular health. Announcement • Feb 09
Centers for Medicare & Medicaid Services Publishes Draft Local Coverage Determination for Renalytix Plc's Kidneyintelx and Kidneyintelx.Dkd Renalytix plc announced that on February 8, 2024 the Centers for Medicare and Medicaid Services published a draft Local Coverage DeterPRODination for the Company's KidneyIntelX and kidneyintelX.dkd testing. The established Medicare price for KidneyIntelX and kidneyintelX.dkd is $950 per test. Distinct CPT Codes (Common Procedural Terminology Codes) have been established for KidneyIntelX and kidneyintelX.dkd and are published in CMS' 2024 Clinical Lab Fee Schedule. The draft LCD specifies coverage for use of KidneyIntelX or kidneyintelX.dkd for patients with diagnosed Type 2 diabetes and Stage 1-3b Chronic Kidney Disease is reasonable and necessary. Any specified limitations for use conform to the U.S. Food and Drug Administration ("FDA") label for kidneyintelX.dkd. The LCD was submitted by National Government Services. NGS is a subsidiary of Elevance Health Inc. (previously Anthem Inc.), a Medicare Administrative Contractor with CMS and responsible for claim review and payment for testing performed in the Company's New York City laboratory. A 45-day public comment period began on February 8, 2024, and ends on March 23, 2024. The Company formally requested an LCD from NGS, and submitted substantial peer reviewed published evidence in support of coverage of KidneyIntelX and kidneyintelX.dkd. NGS held a Contractor Advisory Committee meeting on August 29, 2023, where a panel of external experts reviewed and discussed the clinical evidence. Announcement • Jan 17
Renalytix plc Announces Update on Kidneyintelx.Dkd Local Coverage Determination Consideration Renalytix plc announced that on January 11, 2024, the Medicare Administrative Contractor (MAC), National Government Services (NGS) Inc., released the agenda for a Local Coverage Determination (LCD) Open Meeting taking place on February 29, 2024. The Renalytix KidneyIntelX™? and kidney IntelX.dkd prognostic test for adults with Type 2 diabetes and early-stage chronic kidney disease are one of five proposed LCDs for consideration on the agenda. There are currently an estimated 14 million patients with Type 2 diabetes and early -stage kidney disease in the United States. The proposed LCDs will be published on February 8, 2024. A 45-day public comment period begins on February 8, and ends on March 23, 2024. NGS is a subsidiary of Elevance Health Inc., contracting with the Centers for Medicare & Medicaid Services (CMS) for Jurisdiction 6, encompassing Illinois, Minnesota and Wisconsin, and Jurisdiction K, encompassing Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, and New York. Any Medicare Fee For Service claims for patients tested anywhere in the United States and processed in the Renalytix New York City laboratory are submitted to NGS for payment at the rate established by CMS. Renalytix formally requested an LCD from NGS and submitted substantial peer reviewed published evidence in support of coverage of KidneyIntelX and kidney IntelX.dkD. NGS held a Contractor Advisory Board meeting on August 29, 2023, where a panel of external experts reviewed and discussed the clinical evidence. Based on this evidence, along with the FDA's de novo marketing authorization for the kidney IntelX.dkd tm test, Renalytix believes that there is a strong basis for NGS determining that these tests are reasonable and necessary for Medicare beneficiaries. Following the Open Public Meeting, NGS will review public comments and issue a final LCD which is expected in calendar year 2024. Renalytix also continues to expand private payer coverage agreements across the United States. This coverage includes a January 2024 contract with Velocity National Provider Network, covering 2.7 million member lives nationwide. Announcement • Dec 31
Renalytix Receives Non-Compliance Notice From Nasdaq On December 22, 2023, Renalytix plc (the “Company”) received two written notices (the “Notices”) from the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that (i) because the closing bid price for the Company’s American Depositary Shares (“ADSs”), each representing two ordinary shares, nominal value £0.0025 per share, was below $1.00 per ADS for at least 30 consecutive business days, the Company did not meet the $1.00 per ADS minimum bid price requirement of Nasdaq Listing Rule 5450(a)(1) the (“Minimum Bid Price Requirement”) and (ii) it is not in compliance with the requirement to maintain a minimum market value of listed securities (the “MVLS”) of $50,000,000 for continued listing on The Nasdaq Global Market, as set in Nasdaq Listing Rule 5450(b)(2)(A) (the “MVLS Requirement”). The Notices have no immediate impact on the continued listing or trading of the Company’s ADSs on The Nasdaq Global Market, which will continue to be listed and traded on The Nasdaq Global Market, subject to the Company’s compliance with the other continued listing requirements. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A) and Nasdaq Listing Rule 5810(c)(3)(C), the Company has a compliance period of 180 calendar days, or until June 19, 2024 (the “Compliance Period”), to regain compliance with the Minimum Bid Price Requirement and the MVLS Requirement. To regain compliance with the Minimum Bid Price Requirement, the closing bid price of the ADSs must be at least $1.00 per ADS for a minimum of ten consecutive business days prior to the end of the Compliance Period. To regain compliance with the MVLS Requirement, the Company’s MVLS must close at $50,000,000 or more for a minimum of ten consecutive business days prior to the end of the Compliance Period. If the Company does not regain compliance with the Minimum Bid Price Requirement by the end of the Compliance Period, the Company may be eligible for an additional 180 calendar day period to regain compliance during which it may transfer to The Nasdaq Capital Market, provided that it meets the applicable market value of publicly held shares requirement for continued listing and all other applicable requirements for initial listing thereon (except for the bid price requirement) based on the Company’s most recent public filings and market information and notifies Nasdaq of its intent to cure the minimum bid price deficiency. If the Company meets the applicable requirements, Nasdaq may inform the Company that it has been granted an additional 180 calendar days to regain compliance with the Minimum Bid Price Requirement. If, however, it appears to Nasdaq that the Company will not be able to cure the minimum bid price deficiency, or if the Company is otherwise not eligible for listing on The Nasdaq Capital Market, Nasdaq could provide notice that the Company’s ADSs will become subject to delisting. In such event, Nasdaq rules would permit the Company to appeal the delisting determination to a Nasdaq Hearings Panel. If the Company does not regain compliance with the MVLS Requirement by the end of the Compliance Period, Nasdaq will notify the Company that its securities are subject to delisting, at which point the Company may appeal the delisting determination to a Nasdaq hearings panel. The Company may also choose to transfer the listing of its ADSs to The Nasdaq Capital Market. In order to transfer, the Company must submit an on-line transfer application, pay a $5,000 application fee and meet The Nasdaq Capital Market’s continued listing requirements. The Company intends to actively monitor its MVLS and the closing bid price of its ADS and may, if appropriate, implement available options to regain compliance with the MVLS Requirement and the Minimum Bid Price Requirement. There can be no assurance that the Company will be able to regain compliance with the MVLS Requirement or the Minimum Bid Price Requirement or maintain compliance with any other listing requirements. Announcement • Dec 09
Renalytix plc Announces Step Down of Chirag Parikh as Independent Non-Executive Director Renalytix Plc announced that Dr Chirag Parikh has stepped down from his role as independent Non-Executive Director of Renalytix with immediate effect. The Company will seek to recruit a new independent Non-Executive Director and will provide an update in due course. The Ordinary Resolution to re-appoint Dr Parikh to the Board of Directors will be withdrawn for the Annual General Meeting to be held on 15 December 2023. Announcement • Nov 07
Renalytix Plc to Report Q1, 2024 Results on Nov 14, 2023 Renalytix Plc announced that they will report Q1, 2024 results Pre-Market on Nov 14, 2023 Announcement • Oct 31
Renalytix Plc, Annual General Meeting, Dec 15, 2023 Renalytix Plc, Annual General Meeting, Dec 15, 2023, at 15:30 Coordinated Universal Time. Location: 6 Stratton Street Mayfair,London W1J 8LD London United Kingdom Announcement • Oct 24
Renalytix Plc Announces the Stepped Down of Timothy Scannell as Independent Non-Executive Director Renalytix plc announced that Timothy Scannell has stepped down from his role as independent Non-Executive Director of Renalytix effective as of October 18, 2023, to pursue other opportunities. It has been a wonderful learning experience to work alongside Tim for the past 18 months. He has been a significant contributor to Renalytix. Announcement • Sep 25
Renalytix Plc to Report Second Half, 2023 Results on Sep 28, 2023 Renalytix Plc announced that they will report second half, 2023 results on Sep 28, 2023 Announcement • Sep 08
Renalytix plc Announces the Appointment of Howard Doran as Chief Business Officer Renalytix plc announced the appointment of Howard Doran as Chief Business Officer, effective September 1, 2023. Mr. Doran's primary responsibility will be leading the KidneyIntelX global sales effort. He is a senior executive with over 30 years of diversified general management, strategic planning, and marketing/sales experience in the diagnostics and pharmaceutical industries in domestic and international markets. Mr. Doran served as LipoScience, Inc.'s President and Chief Executive Officer until successful completion of LabCorp's acquisition of the company in November 2014. Preceding LipoScience, Mr. Doran was President and Chief Operating Officer of Constitution Medical Inc., an early-stage in vitro diagnostics company and developer of the Bloodhound Fully Integrated Hematology System, which was acquired by Roche Diagnostics Inc. in July 2013. Prior to Constitution Medical, Mr. Doran was a member of the senior executive team of Hologic Inc. and served as President of Hologic's Global Diagnostics business. Mr. Doran joined the senior management team of Hologic in 2007 at the time of Hologic's acquisition of Cytyc Corporation, where he had been serving as Senior Vice President and Business Unit Director of Cytyc's $500 million in vitro diagnostics business. From 1997 through 2007, he was a key member of the management team of Cytyc Corporation during Cytyc's dramatic growth, serving in a number of senior commercial roles of increasing responsibility including physician sales and marketing, managed care initiatives and laboratory sales and marketing. Mr. Doran holds a Bachelor of Science degree in Management from West Chester University of Pennsylvania. Announcement • Aug 04
Renalytix plc Announces Appointments to Its Clinical Advisory Board Renalytix plc announced the launch of its Clinical Advisory Board, a world-leading, multi-disciplinary clinical group, to help advance the use of FDA authorized kidneyintelX.dkd™ in mitigating uncontrolled kidney disease progression and guiding early stage treatment strategies for the estimated 14 million Americans with diabetic kidney disease. The Clinical Advisory Board members include: Stephen Brunton, MD, FAAFP, CDCES; University of North Carolina, Executive Director of Primary Care Metabolic Group (PCMG) and Editor-in-Chief of Clinical Diabetes Matthew Jay Budoff, MD, FACC, FAHA; David Geffen School of Medicine at UCLA and Endowed Chair of Preventive Cardiology at Harbor-UCLA Medical Center Barry I. Freedman, MD, FACP; John Felts Distinguished Professor and Chief of the Nephrology Section at Wake Forest University School of Medicine Ralph A. DeFronzo, MD; Professor of Medicine and Chief of the Diabetes Division at the University of Texas Health Science Center and the Deputy Director of the Texas Diabetes Institute Holly J. Mattix-Kramer MD, MPH; Division of Nephrology and Hypertension at Loyola University Chicago, Associate Director of Research for the Medicine Service Line and Founding Director of the Hines VA Serwa Research Center on Aging Javier Morales MD, FACP, FACE; Vice President and Principal Clinical Trials Investigator at Advanced Internal Medicine Group Joseph A. Vassalotti MD; Chief Medical Officer of the National Kidney Foundation (NKF) and Clinical Professor of Medicine in the Division of Nephrology at Icahn School of Medicine at Mount Sinai Eugene E. Wright Jr., MD; Duke University Medical Center and Medical Director for Performance Improvement at the Charlotte Area Health Education Center. Announcement • Jul 08
Renalytix Plc Announces Late-Breaking KidneyIntelX Evidence Released at American Diabetes Association Scientific Sessions Renalytix plc announced late-breaking new clinical data demonstrating that KidneyIntelX in vitro prognostic use was associated with post-test actions that led to sustained improvements in both type 2 diabetes and chronic kidney disease health through 12 months. The results are from the evaluation of 2,317 patients being followed in a large real-world evidence (RWE) study in New York City. The twelve-month outcome data were presented at the American Diabetes Association (ADA) 83rd Scientific Sessions held June 23-26, 2023, in San Diego, California. There are approximately 14 million adults with diabetic kidney disease in the U.S. and that number could more than double by the year 20602 due to rising trends in obesity and diabetes. KidneyIntelX is designed for use in patients with type 2 diabetes and stages 1-3 of kidney disease (early-stage diabetic kidney disease, DKD) to assess which patients are at low, intermediate, or high risk for a rapid progressive decline in their kidney function. Type 2 Diabetes Improvements Evidenced by Hemoglobin A1c in Higher Risk Groups: In patients classified as high risk, median A1C levels improved by 0.7%, a decrease from 8.2% (pre-test) to 7.5 (post-test) at one year (p< 0.001); median HbA1c decreased from 7.5% to 7.3% for patients in the intermediate risk group (p=0.001), and median A1C decreased from 7.1% to 7.0% in the low risk patients. (p=0.9). These results support that the previously published improvement in A1C levels observed at six months pre and post KidneyIntelX testing, has been sustained for the full year, especially in the higher-risk patients. GFR slope is widely accepted as a clinical measure to determine the progression of chronic kidney disease (CKD). In patients classified as high risk by KidneyIntelX, median eGFR slope improved from -7.1 (pre-test) to 4.5ml/min/1.73m2 (post-test) at one year (p=0.01), indicating a slowed progression of their disease. For patients with an intermediate risk score, median eGFR slope was stable at -1.5 (pre vs. post-test) to -1.4ml/min/1.73m2 at one year (p=0.6) while patients classified as low risk, the median eGFR slope improved from -1.9 (pre-test) to -0.28 ml/min/1.73 m2/year (p<0.01), further highlighting a need for broad engagement at both ends of the risk spectrum. This data builds upon the RWE 6-month interim results published in the Journal of Primary Care and Community Health (November 2022) which demonstrated a reduction in the amount of urinary (albumin) protein in the low and intermediate KidneyIntelX risk groups. The authors concluded that the use and deployment of KidneyIntelX to risk stratify patients with early-stage diabetic kidney disease was associated with escalation in various actions taken to optimize cardio-metabolic-kidney health, including guideline-based pharmacy management and specialist consultation. Furthermore, glycemic control and kidney health improved post-KidneyIntelX testing, with the largest improvements observed in those scored as high-risk. Importantly this data demonstrates that implementation of KidneyIntelX in patient care leads to improved clinician and patient engagement directed to slowing the progression of diabetic kidney disease and associated cardiovascular complications. In addition, during the ADA meetings, the Company presented validation data from a new IVD assay developed utilizing the KidneyIntelX platform. The risk score calculation was updated to incorporate the new race-free eGFR calculation, the availability of contemporary patient cohorts reflecting recent changes in care for diabetic kidney disease, and simplification of test inputs to enhance clinical adoption in the primary care setting. The updated version of KidneyIntelX utilizes the same three biomarkers, and three clinical features. It was validated in an external cohort with overall excellent performance characteristics which included diverse subgroups of the intended use population. Announcement • Jul 04
Renalytix plc Appoints Catherine Coste to Board of Directors, Non-Executive Chair of the Audit Committee and a Member of the Remuneration Committee Renalytix plc announced the appointment of Catherine Coste to the Company's Board of Directors, effective June 30, 2023. Ms. Coste was also appointed as the Non-Executive Chair of the Audit Committee and a member of the Remuneration Committee. Ms. Coste has extensive financial experience having retired from Deloitte and Touche LLP ("Deloitte") in 2020, where she was a senior partner and served as one of Deloitte's life sciences industry executive leaders. She spent 32 years in both corporate and professional services positions leading global finance, internal audit and operations teams. During her career at Deloitte, Ms. Coste was directly involved with over 30 life science corporations, the majority of which were large-cap and medium-cap public corporations. Ms. Coste also has comprehensive public company board experience and currently serves as a director of both Minerva Surgical Inc. where she serves as Chair of the Audit Committee and as member of the Compensation Committee, and Biomerica Inc., where she is Chair of the Audit Committee, and serves on the Compensation Committee and the Nominating and Corporate Governance Committee. Ms. Coste also has extensive experience in Sarbanes-Oxley compliance, corporate risk analysis and management, cyber risk assessment, fraud prevention, IT systems analysis and upgrades, internal controls, and corporate governance. Ms. Coste is a Certified Public Accountant. Ms. Coste earned her B.A. in business administration, accounting, from California State University, Hayward. Announcement • Jul 01
Fda Grants De Novo Marketing Authorization for Kidneyintelx.Dkd to Assess Risk of Progressive Kidney Function Decline in Adults with Diabetes and Early-Stage Kidney Disease of Renalytix plc Renalytix plc announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for its KidneyIntelX.dkd ™ prognostic test. This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease. Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international regulatory approvals. KidneyIntelX.dkd accurately stratifies patients into three risk levels (low, moderate, and high). This result provides comprehensive information on patient risk for progressive decline in kidney function within five years, independently of the current standard of care measures. KidneyIntelX.dkd is the name used to differentiate tests to be provided under the De Novo marketing authorization by the FDA from those provided under the KidneyIntelX name as a Laboratory Developed Test. Since being introduced as a Laboratory Developed Test (LDT), KidneyIntelX results have been reported on approximately 10,000 patients in the United States and there has been broad insurance payment including from Medicare and many private payers. The KidneyIntelX platform combines blood-based biomarkers with clinical variables using an artificial intelligence enabled algorithm, providing reliable and actionable information to guide care in large, at-risk patient populations. KidneyIntelX is based on technology developed at the Icahn School of Medicine at Mount Sinai in New York, NY, and licensed to Renalytix. Announcement • Jun 16
Renalytix Plc Announces KidneyIntelX™ Clinical Decision Impact / Validation and Health Economic Data to be Presented at Upcoming Scientific Conferences Renalytix plc announced that three scientific abstracts have been accepted at the upcoming American Diabetes Association 83rd Scientific Sessions (June 23-26, 2023) in San Diego, California and another abstract has been accepted at the American Association of Nurse Practitioners National Conference (June 20-25, 2023) in New Orleans, Louisiana. Accepted abstracts reflect the growing body of scientific evidence demonstrating the important role KidneyIntelX serves towards advancing patient care and awareness for early-stage diabetic kidney disease. The presentations at the American Diabetes Association 83rd Scientific Sessions meeting include late-breaking data from a multi-year real-world evidence study, extended validation of KidneyIntelX, and a cost-effectiveness analysis addressing economic benefit in the VA population. In addition to multiple data presentations, Renalytix will be hosting three medical education events covering real-world evidence data unveiled at the conference so that clinicians may discuss and engage with the Renalytix leadership team as well as their peers in nephrology, endocrinology, and primary care providers. American Diabetes Association 83rd Scientific Sessions presentations will be displayed over three days June 24-26, 2023, and moderated at the specified times below. Presentations related to KidneyIntelX will also be published on the journal Diabetes® website. Late-breaker Presentation:"Clinical Impact of Risk Profiling with KidneyIntelX on DKD Progression in a Large Integrated Health Care System" will be presented by Dr. Joji Tokita, principal investigator of the multi-year real-world evidence study and practicing clinician at the Mount Sinai Health System and moderated on Saturday, June 24, 2023, from 11:30am-12:30pm PDT. · Poster presentation: "Extended Validation of KidneyIntelX™ in Diabetic Kidney Disease"presented by Dr. Girish Nadkarni, Director, The Charles Bronfman Institute of Personalized Medicine System Chief, Division of Data-Driven and Digital Medicine (D3M) and The Irene and Dr. Arthur Fishberg Professor of Medicine of Mount Sinai Health System and moderated on June 26, 2023. · Poster presentation: "Cost of Care for Patients with Diabetic Kidney Disease in Veterans Health Administration"presented by Kibum Kim, BPharm, PharmD, Assistant Professor Department of Pharmacy Systems, Outcomes and Policy, University of Illinois Chicago and moderated on Sunday June 25, 2023, from 11:30am-12:30pm PDT. An American Association of Nurse Practitioner (AANP) Conference presentation will be displayed June 22-24, 2023, and moderated over three days: Poster presentation: "Understanding Patient Receptivity Towards Receipt of Prognostic Risk Score for Diabetic Kidney Disease" will be presented by Renalytix on behalf of the Patient Care Navigation Team at Mount Sinai Health System and focused on the significant impact KidneyIntelX can have on patients' enhanced understanding of kidney disease and motivation to make lifestyle changes, as well as the role nurse practitioners play in influencing patient behavior and clinical outcomes. The poster will be moderated June 22-24, 2023, at various times based on central time zone .KidneyIntelX is a blood test that assesses risk for rapid progressive decline in kidney function and is intended for use in adult patients with type 2 diabetes and early-stage CKD (stage 1-3). The KidneyIntelX risk score can assist clinicians, including primary care providers and endocrinologists, in guiding resource utilization, prescription of new therapeutic agents and improve efficiency of care among physicians. New Risk • Jun 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$40m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$40m free cash flow). Shares are highly illiquid. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$6.1m net loss in 3 years). Shareholders have been diluted in the past year (25% increase in shares outstanding). Revenue is less than US$5m (US$3.7m revenue). Market cap is less than US$100m (US$97.3m market cap). Announcement • Jun 05
Renalytix Plc to Report Q3, 2023 Results on Jun 09, 2023 Renalytix Plc announced that they will report Q3, 2023 results Pre-Market on Jun 09, 2023 Announcement • May 12
Renalytix Plc, Annual General Meeting, Jun 08, 2023 Renalytix Plc, Annual General Meeting, Jun 08, 2023, at 14:00 Coordinated Universal Time. Location: the offices of Harwood Capital LLP, 6 Stratton Street Mayfair, London W1J 8LD London (United Kingdom) United Kingdom Announcement • Jan 28
Renalytix plc Announces the Launch of PRIME-CKD Renalytix plc announced the launch of PRIME-CKD, a consortium of industry, academic and clinical research leaders, that aims to validate and implement in clinical practice, novel biomarker-based tests that predict response to existing drugs used by patients with chronic kidney disease (CKD). PRIME-CKD is funded by Horizon Europe, the European Union’s key funding program for research and innovation. The total budget of the project is $10 million over a projected five-year period with approximately 10% of the budget targeted for commercial translation activities to be undertaken by Renalytix. The company expected the project to benefit from Renalytix’s substantial expertise in biomarker research translation and existing intellectual property on urinary Epidermal Growth Factor (uEGF) for which Renalytix has exclusive access from the University of Michigan. The project is closely aligned with Renalytix’s objective of expanding the clinical utility of the KidneyIntelX platform beyond prognosis to prediction and monitoring of drug response. The consortium brings together leading experts from 11 academic institutions, together with partners from patient representative foundations and regulatory agencies. The PRIME-CKD consortium is committed to demonstrating the utility of novel biomarkers as tools for better selection of drug therapies for patients, for use both in daily clinical practice and innovative clinical trials. Notably, if certain biomarkers are successful, the PRIME-CKD program will seek qualification of these biomarkers through the European Medicines Agency and the United States Food and Drug Administration (FDA) for this purpose. Kidney disease is a public health epidemic affecting over 850 million people globally. The Centers for Disease Control and Prevention estimates that 15% of U.S. adults, or approximately 37 million people, have chronic kidney disease (CKD). Nearly 95% of people with CKD are in early stages 1-33. Despite its magnitude, early-stage (1-3) CKD is underdiagnosed and undertreated, largely because it’s asymptomatic at this time in the disease. As many as 9 in 10 adults with CKD, and about 2 in 5 adults with severe CKD do not know they have the condition.