Renalytix Share Discussion Threads

[wan] 10/6/2022 07:42

Todays RNS update is quite revealing regarding testing within Mount Sinai, and also provides very encouraging results that should pique the interest of nephrologists, endocrinologists or dietitians in terms of engagement outside of Mount Sinai, and indeed the onboarding of additional hospital systems.

And given the insights provided on overcoming physician inertia with regard to novel therapeutics, it should also pique the interest of biopharma (some of who already have the heads under the KidneyIntelX bonnet) -

"KidneyIntelX test helped physicians overcome the inertia seen with novel therapeutics proven to slow CKD progression and reduce associated patient cardiovascular event risk. As compared to patients who scored low risk, there were increases in use of anti-hypertensives, a 6-fold increase in the initiation of guideline-recommended treatments (SGLT-2 inhibitors or GLP-1 receptor agonists), and a nearly 3-fold increase in referrals to nephrologists, endocrinologists or dietitians. In the high-risk patient category, 20% of patients were referred to a specialist. Additionally, there was an increase in appropriate use of SGLT-2 inhibitor prescriptions by increased level of risk score."

[wan] 08/6/2022 07:59

Bayers Kerendia data supports individual use or complements chronic kidney disease treatments such as AstraZeneca’s Farxiga and Johnson & Johnson’s Invokana. KidneyIntelX might be needed individually, or indeed when treatments complement each other -


ADA: Bayer builds its case for potential kidney disease blockbuster Kerendia
By Zoey BeckerJun 7, 2022

“As clinicians make their choices about these medications, I think the important takeaway for them is that this drug works, whether they are using it in conjunction with or in the absence of other diabetes medicine that have excellent impact on cardiovascular renal disease,” Bansilal added.

[toffeeman] 06/6/2022 11:14

If (like me) you were invested in AGL as well, you would realise the problems surrounding FDA approval - it really is a black box with uncertain dimensions.

[74tom] 06/6/2022 10:32

They confirmed multiple times on the quarterly calls that there were no dealbreakers & that if they were they would be RNS’d as it’s material information. So we know it’s not on hold, just working it’s way through the process. Angle was almost exactly the same and they got there in the end (400+ documents later).

[mr roper] 06/6/2022 10:09

There's a pretty clear timeline for the fda process. It's obvious it's been disrupted by covid but there's other information that could be provided to investors on the general status apart from.."we're talking to them". It could be on hold, we may have submitted additional info, we may have received x amount of responses from the fda...but we know zero.

[74tom] 06/6/2022 10:03

I strongly disagree with your viewpoint - how can they be clear with investors about an approval process which is interminable in length and likely includes many ad hoc requests? If they were too specific with the KidneyIntelx De Novo requirements / timelines then they would end up looking like amateurs when another data request landed or timelines got pushed back.

I also think it looks desperate to communicate too often on regulatory matters and it could even have a negative effect on the likelihood of approval. The pandemic had an undeniable negative impact, to claim it’s had nothing to do with the delay is madness in my opinion.

Just switch off and believe in what they are trying to achieve, the FDA issue will resolve itself at some point this year.

[mr roper] 06/6/2022 09:27

It's got nothing to do with the pandemic. It's got everything to do with being clear with investors.

All we get is. " the fda guys are working hard down there", "we're having good dialogue"

And we're still none the wiser

[wan] 06/6/2022 08:30

I am not making excuses, far from it! But I am not sure how Renalytix or Mount Sinai (or anyone!) could have anticipated, and therefore fully factored in, the effects from the pandemic and its variants.

[mr roper] 06/6/2022 08:25

I've not glossed over that, wan. My point is around transparency.

[wan] 06/6/2022 08:24

Mr Roper...Please don't forget the part the devastating effects the pandemic played, which did not just delay the FDA, but also and perhaps to a greater extent, Mount Sinai Health System and the Icahn School of Medicine at Mount Sinai who conducted the Real-World Evidence Study.

[mr roper] 06/6/2022 08:03

That's part of the problem. It's a black box to investors. If they needed rwe data why were we led to believe approval would come last year without it. If its the fda moving the goalposts or requiring us to jump another hurdle the company should be clear about that.

[wan] 06/6/2022 07:57

Renalytix has already stated they have been working hard with the FDA. So, my main thrust is that the FDA 'need' such data and evidence for KidneyIntelX, which might therefore be an important, if not pivotal element in the process.

[mr roper] 06/6/2022 07:46

Fda need to get their finger out though

[wan] 06/6/2022 07:41

A combination of significant and important data and real-world-evidence revealed, and demonstrating KidneyIntelX can help to address unmet needs in diabetic kidney disease.

Such data and evidence are utilised by the FDA in making regulatory decisions and the healthcare community to support coverage decisions -

Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.

> FDA uses RWD and RWE to monitor postmarket safety and adverse events and to make regulatory decisions.

> The health care community is using these data to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice.

>Medical product developers are using RWD and RWE to support clinical trial designs (e.g., large simple trials, pragmatic clinical trials) and observational studies to generate innovative, new treatment approaches.

The 21st Century Cures Act, passed in 2016, places additional focus on the use of these types of data to support regulatory decision making, including approval of new indications for approved drugs. Congress defined RWE as data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials. FDA has expanded on this definition as discussed below.

Full details -

[mr roper] 06/6/2022 07:13

Nice study results

[wan] 04/6/2022 10:42

I posted the following article back in January, and with half of 2022 nearly gone, it would appear there is a 'lot' of news flow expected to come in the second half of 2022 -

JPM 2022: Renalytix plots de novo FDA nod for kidney disease AI, expands into drug response monitoring
By Andrea ParkJan 13, 2022

After spending the past few years laying the groundwork for a full-scale launch of its KidneyIntelX technology, Renalytix is predicting that “2022 is going to be a heavy year of milestones,” CEO James McCullough said during a presentation at the J.P. Morgan Healthcare Conference Wednesday.

Full article -

Clearly some of those milestones e.g. FDA approval, pharmaceutical and other strategic partnerships etc, have the potential to provide material inflection points in terms of the share price.

Critically some would argue, we might also get see inaugural testing and revenue guidance, which also has the potential to change the dynamics given how the market is currently treating certain growth companies, especially those not able (or willing) to deliver this clearly important aspect.

[wan] 04/6/2022 08:49

Recall that the KidneyIntelX™ platform is being used by investigators from the Icahn School of Medicine at Mount Sinai to assess the risk of adverse kidney events in patients diagnosed with COVID-19 -

KidneyIntelX™ to Predict Major Adverse Kidney Events in COVID-19 Patients

NEW YORK, April 20, 2020 /PRNewswire/ -- Renalytix AI plc (LSE: RENX), the AIM-traded developer of clinical grade artificial intelligence in vitro diagnostics for kidney disease, announces that the KidneyIntelX™ platform will be used by investigators from the Icahn School of Medicine at Mount Sinai to assess the risk of adverse kidney events in patients diagnosed with COVID-19. Acute and chronic kidney disease is strongly associated with severity of disease and fatal outcomes in COVID-19 patients. Evaluation of a patient's kidney risk status at the time of COVID-19 diagnosis, through recovery and during follow-on monitoring, can be of potentially high clinical value.

The KidneyIntelX platform will be used in a large study of COVID-19 admitted patients at Mount Sinai called "Pred-MAKER" (Prediction of Major Adverse Kidney Events and Recovery). Pred-MAKER will study clinical features and biomarkers, including multiple plasma biomarkers and urine proteomics and RNA sequences, as predictors of major adverse kidney events in patients hospitalized with COVID-19. The study has been submitted for Institutional Review Board (IRB) review and approval.

"Given the evidence that there is extensive systemic inflammation as well as kidney tubular injury in patients with COVID-19, the KidneyIntelX platform is well positioned to play a prominent role in understanding which patients are at highest risk of severe kidney complications and which patients are more likely to experience longer-term detrimental effects of COVID-19 infection," said Dr. Steven Coca, co-founder of RenalytixAI and co-Investigator in Pred-MAKER.

Full release -

Prediction of Major Adverse Kidney Events and Recovery (Pred-MAKER) in COVID-19 Patients
Project Number
3R01DK118222-03S1
Contact PI/Project Leader
AZELOGLU, EVREN U.
Awardee Organization
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI


And there is now further evidence of adverse kidney events due to COVID-19 -

Millions of Covid-19 patients are warned they may have a deadly hidden kidney disease as shock medical study finds one in five are at risk - but it can be treated if detected early

New study found one in five hospitalised virus patients get acute kidney disease
Kidney specialist Dr Marina Wainstein said Covid patients could be at double risk
Doctors test for the disease by monitoring urination and blood creatinine levels
If levels aren't checked before hospitalisation the disease could be undiagnosed
By MARTY SILK FOR AUSTRALIAN ASSOCIATED PRESS

PUBLISHED: 02:40, 3 June 2022 | UPDATED: 06:07, 3 June 2022

Millions of Covid patients may have an undiagnosed, potentially fatal acute kidney disease, according to a new study.

University of Queensland researchers say one in five virus patients admitted to hospital and two in five in intensive care develop acute kidney disease (AKI), a condition where the kidneys fail to filter waste from the blood.

University of Queensland PhD candidate and kidney specialist Dr Marina Wainstein says a new study indicates AKI rates in Covid patients could be double that.

Full story -

This could result in a lot of additional testing being required in order to prevent severe kidney complications and fatal outcomes.

[wan] 03/6/2022 04:45

Two presentations, one today and one on the 5th -

Renalytix Announces Two Data Presentations on KidneyIntelX™ at American Diabetes Association 82nd Scientific Sessions®
June 02, 2022

NEW YORK and SALT LAKE CITY, June 02, 2022 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced its participation at the American Diabetes Association (ADA) 82nd Scientific Sessions® meeting in New Orleans from June 3-7, 2022. There will be two data presentations focused on the value of KidneyIntelX™ in care for adult patients with type 2 diabetes (T2D) and early-stage chronic kidney disease (CKD), including a late-breaking ePoster and an oral presentation.

Full release -

[wan] 01/6/2022 07:39

Following on from my post 1785, I repeat the following -

Connecting a few more dots -

Wake Forest University Health Sciences and Barry Freedman have rights to an issued US patent related to APOL1 genetic testing.

Rapid APOL1 genetic testing services are based on the research of Barry I. Freedman, MD, John H. Felts, III Professor and Chief of Nephrology at Wake Forest. Freedman is an active clinician-researcher whose research focuses on genetic causes of kidney and cardiovascular disease, hypertension and type 2 diabetes, particularly in African-Americans; as well as clinical outcomes in chronic kidney disease and after renal transplantation.

Dr Freedman is part of Renalytix Scientific Advisory Board.

Renalytix recent announcement -

Renalytix Launches myIntelX, Providing National Physician Access to KidneyIntelX Testing Platform
March 9, 2022

myIntelX will be launching in conjunction with KidneyIntelX going live at Atrium Health, and will expand testing services across all Renalytix healthcare provider partners

(END)

For further background information on Wake Forest/Atrium Health -
Atrium Health is a nationally recognized leader in shaping health outcomes through innovative research, education and compassionate patient care. Based in Charlotte, North Carolina, Atrium Health is an integrated, nonprofit health system with more than 70,000 teammates serving patients at 40 hospitals and more than 1,400 care locations. It provides care under the Atrium Health Wake Forest Baptist name in the Winston-Salem, North Carolina, region, as well as Atrium Health Navicent and Atrium Health Floyd in Georgia and Alabama. Atrium Health is renowned for its top-ranked pediatric, cancer and heart care, as well as organ transplants, burn treatments and specialized musculoskeletal programs. A recognized leader in experiential medical education and groundbreaking research, Wake Forest University School of Medicine is the academic core of the enterprise, including Wake Forest Innovations, which is advancing new medical technologies and biomedical discoveries. Atrium Health is also a leading-edge innovator in virtual care and mobile medicine, providing care close to home and in the home. Ranked nationally among U.S. News & World Report’s Best Hospitals in eight pediatric specialties and for rehabilitation, Atrium Health has also received the American Hospital Association’s Quest for Quality Prize and its 2021 Carolyn Boone Lewis Equity of Care Award, as well as the 2020 Centers for Medicare & Medicaid Services Health Equity Award for its efforts to reduce racial and ethnic disparities in care. With a commitment to every community it serves, Atrium Health seeks to improve health, elevate hope and advance healing – for all, providing more than $2 billion per year in free and uncompensated care and other community benefits.


Testing for Genetic Risk for Kidney Failure in Patients of African Ancestry
By Victoria Socha

May 31, 2022

High-risk genotypes at the apolipoprotein L1 (APOL1 ) locus confer a 5-fold to 10-fold increased risk for CKD and ESKD attributed to hypertension; the risk increment is attenuated among individuals with diabetes. High-risk variants of APOL1 (OMIM 603734) on chromosome 22 are found in one in 17 people of African ancestry but are nearly absent in people of European ancestry.

Of late, interest in incorporating genetic testing into primary care has increased. The APOL1 risk genotype is common and carries high risk for CKD in individuals of African ancestry who are disproportionally burdened by chronic diseases, creating a need for the incorporation of genetic testing into clinical care. Kidney function deterioration can be reduced with blood pressure control, but those of African ancestry have the highest age-adjusted prevalence of hypertension and the lowest rates of blood pressure control. Further, tests of kidney function are underused among patients at high risk for CKD.

In conclusion, the researchers said, “Return of APOL1 genetic testing results combined with EHR-based clinical decision support and disclosure of results to patients using laypersons improved systolic blood pressure control and increased guideline-appropriate kidney function testing. These results may support an approach of broad implementation of genetic medicine in primary care. This broad implementation will benefit racial and ethnic minority groups that have been traditionally under-represented in both clinical trials and genetic studies. Because it is imperative not to overlook the importance of social determinants of health in affecting chronic disease, it will also be important to understand and address the intersection of social and biological determinants in patient health.”

Takeaway Points

1. Results of a pragmatic randomized clinical trial designed to examine the effects of testing and disclosing APOL1 genetic results to patients of African ancestry with hypertension and their clinicians.
2. Patients were randomized to receive immediate (intervention) or delayed (control) APLO1 testing results. Patients in the immediate results group received results from trained staff; those in the delayed group received results after a 12-month follow-up visit.
3. Patients with high-risk APOL1 genotypes had greater improvement in blood pressure from baseline and more lifestyle changes than those with low-risk APOL1 genotypes or controls.


Renalytix appear to be in a strong position to secure (possibly exclusive?) rights to the use of APOL1

Girish N. Nadkami, MD, MPH is a co-founder of Renalytix

[74tom] 27/5/2022 21:07

HA. It’s a 5 year convertible bond Jaknife, if they’ve not got FDA by then we won’t be here!

Closed up 17% on NASDAQ at $4.20 which is equivalent to £1.66, so we should have a strong start here on Monday.

Let’s hope this is the start of a rebound from these ridiculous levels.

[yasx] 27/5/2022 16:22

Mr Roper,

My view is the absence of forward guidance and pathway to revenues is a consequence of the failure to secure the FDA approval.

[mr roper] 27/5/2022 12:46

Definitely seems to be a major contributor Yasx but I’d say the lack of forward guidance and clear plan for revenue growth has had an equal if not greater impact.