Renalytix Share Discussion Threads

[wan] 06/10/2022 14:39

Serritia...Delay in FDA approval. Lack of commercial traction i.e. meaningful revenue generation, and nothing tangible on the 'referred to strategic partnering' with either diagnostics or pharma. And obviously the market backdrop, which particularly does not like any of the above!

Lots of other stuff is slotting into place though and 'tangible' progress in any one of those areas above could have a very positive and material effect on the share price.

[serratia] 06/10/2022 13:59

I have a number of shares on my watch list. Too many to go into a deep analysis. RENX is one of those shares.I saved it as what they can do seemed very valuable to patients / companies / health services. It's fallen 96% from its peak and is now worth less than £40m.
The fall greatly exceeds the AIM / market drop so what has happened? I'm not aware of any disaster. Can anyone say in a few lines what's precipitated the collapse as it still seems to be an interesting company ?
Thanks for any response either way.

[wan] 06/10/2022 08:50

New Consensus on Diabetes and Chronic Kidney Disease Together
Mitchel L. Zoler, PhD

October 05, 2022

The American Diabetes Association (ADA) and the Kidney Disease: Improving Global Outcomes (KDIGO) organization have together spelled out broad agreement on how clinicians should now manage patients with diabetes and chronic kidney disease (CKD) in a new consensus report published online October 3 in Diabetes Care and Kidney International.

The report focuses on how to use available diabetes medications to optimize slowing the progression of CKD while also applying best practices for controlling glycemia and minimizing other diabetes complications. It also highlights new evidence supporting use of agents from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class in patients with an estimated glomerular filtration rate (eGFR) as low as 20 mL/min/1.73m2.

A major thrust of the consensus is a framework that details how clinicians can best orchestrate three new, important drug classes that have revolutionized management of CKD in people with diabetes: SGLT2 inhibitors, glucagon-like peptide (GLP)-1 agonists, and nonsteroidal mineralocorticoid receptor antagonists (specifically finerenone).

The planned consensus report was discussed at the ADA 82nd Scientific Sessions.

"These are very important drugs that are vastly underused," commented Josef Coresh, MD, PhD, at the time. "Coherence and simplicity are what we need so that there are no excuses about moving forward" with the recommended combination treatment, stressed Coresh, an epidemiologist and professor at Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, who specializes in CKD and was not involved with the new statement.

"Broad Agreement" Between ADA and KDIGO
The writing panel says the goal of the consensus report is to highlight shared recommendations from the ADA's updated Standards of Medical Care in Diabetes —2022 and KDIGO's 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease.

The document represents "broad agreement" between the two groups on the "evidence-based management of adults with diabetes and CKD," they note.

It contains seven specific consensus statements:

Full article -

[wan] 05/10/2022 14:14

Recent and quite Interesting -

Catherine Liu, PharmD, BCPS, BCGP (She/Her)
Lead Clinical Pharmacy Manager at Mount Sinai Health System

About
I am currently the Lead Clinical Pharmacy Manager of Population Health and KidneyIntelX at Mount Sinai Health System. I am board certified in geriatric pharmacy and pharmacotherapy and certified in Collaborative Drug Therapy Management.

Experience

Mount Sinai Health System
Full-time · 1 yr 2 mos Full-time

Lead Clinical Pharmacy Manager, KidneyIntelX

Jul 2022 - Present · 4 mos
Clinical Pharmacy Manager
Sep 2021 - Present · 1 yr 2 mos

[wan] 05/10/2022 12:13

KidneyIntelX has expanded the pipeline, which now includes intelX.vista -

The test aims to provide doctors with valuable insights about their adult diabetic kidney disease patients garnered from a broader and longer-term view through ongoing monitoring, repeat testing, and the evaluation of different therapeutics.


Having noted all of the above, the market needs more than a positive backdrop of scientific evidence and potential.

Hopefully, the CEO will have more to say in this regard, especially something 'tangible' in terms of commercialisation and partnering (long overdue!), including demonstration of the business commercially either separately or within the upcoming Results, as a repetition of what we are already well versed in will not suffice in this market!

[wan] 05/10/2022 11:58

Staying with the CKD Biomarker Consortium -

CKD Biomarkers: Focusing on the Future
Investigators of CKD BioCon will hold a meeting on November 1 -2, 2022 in Orlando, FL. to review the consortium’s findings and discuss the opportunities for biomarker research in kidney diseases presented by BioCon investigators. Also included in this meeting will be an informal networking and informational poster session, an early stage investigator session about how to access BioCon data, an optional one-on-one mentoring session with BioCon investigators for early stage investigators, and a panel discussion about opportunities and directions of future biomarker research in CKD that will include representatives from industry, those living with CKD, the FDA, and various research organizations.

Over two days (Agenda), this meeting will provide participants with opportunities to:

1. Learn about CKD BioCon findings
2. Learn about the extensive data resources generated by CKD BioCon and how to access them
3. Learn about the available opportunities to get involved with CKD BioCon data
4. Brainstorm about possible areas of future investigation
5. Network with and receive mentorship from established CKD biomarker researchers
6. Understand more about the process of biomarker qualification, the use of biomarkers in clinical trials and drug development

Excerpt -
Biomarker Think Tank – Panelists will discuss their perspectives on CKD biomarker
research and future directions in the field (~10 minutes per panelist), followed by
moderator led discussion

Panel participants:
Nicholas King, MS - Critical Path Institute
Stefan Sultana, MD - AstraZeneca
Aliza Thompson, MD - U.S. Food and Drug Administration
Frank Dieterle, PhD - Novartis
Paul Conway - American Association of Kidney Patients
Katherine T Landschulz, PhD - Labcorp Drug Development

[wan] 05/10/2022 11:45

The Next Frontier: Biomarkers and Artificial Intelligence Predicting Cardiorenal Outcomes in Diabetic Kidney Disease
Gregory L. Braden and Daniel L. Landry
Kidney360 September 2022, 3 (9)

Despite the robust promise of serum biomarkers, newer studies of urinary biomarkers have led to more complicated results. The CKD Biomarker Consortium in the CRIC Study found that only urinary KIM-1 was associated with cardiovascular outcomes and death, and none of the urinary biomarkers after adjustment for eGFR and albuminuria were associated with diabetic kidney disease progression (13,14). However, recent studies in diabetes showed that urine MCP-1 was associated with renal decline, and urinary markers of proximal tubular origin, inflammation, and fibrosis were associated with progression of diabetic CKD (15,16).

To fill the void and current predictive models of diabetic CKD, investigators for the CKD Biomarker Consortium and others have developed a machine learning-derived prognostic test, KidneyIntelX, which has integrated known biomarkers consisting of levels TNF-1, TNF-2, and KIM-1 with electronic health record (EHR) data to predict longitudinal outcomes in two populations: a Mount Sinai biobank of patients with type 2 diabetes mellitus and an African American registry database of patients with APO L-1 risk alleles (17).

Taken together, the history of biomarker research looking at CKD outcomes has now evolved into the arena of cardiac trends in the outcomes of diabetic nephropathy. Using artificial intelligence of the EHR data in these patients will hopefully lead to better models to predict progression of CKD and cardiorenal outcomes and will hopefully lead to new targeted precision therapies to slow progression of his CKD and diabetes

[wan] 05/10/2022 11:23

From Kidey360 Vol. 3, Issue 9
29 Sep 2022 -

A Post Hoc Analysis of KidneyIntelX and Cardiorenal Outcomes in Diabetic Kidney Disease
Girish N. Nadkarni, Dipti Takale, Bruce Neal, Kenneth W. Mahaffey, Yshai Yavin, Michael K. Hansen, Fergus Fleming, Hiddo J.L. Heerspink and Steven G. Coca
Kidney360 September 2022, 3 (9)

Key Points

KidneyIntelX, a bioprognostic test for assessing risk of CKD progression, risk stratified individuals for kidney, heart failure, and death outcomes in the Canagliflozin Cardiovascular Assessment Study.

Individuals scored as high risk seemed to derive more of benefit from treatment with canagliflozin versus placebo.

These findings may serve to increase adoption of underutilized therapies for cardiorenal risk reduction in patients with diabetic kidney disease.

In conclusion, we demonstrated that KidneyIntelX, a composite risk score trained and validated for a kidney-specific outcome, provided risk stratification for a triple composite end point that included not only the kidney-specific outcome of progression, but also clinically relevant outcomes of hospitalizations for heart failure and all-cause mortality, even after adjusting for several other risk factors for these outcomes. These findings suggest that KidneyIntelX may have utility as a clinical trial enrichment tool for therapies to ameliorate cardiorenal risk and provides further impetus to increase adoption of underutilized guideline-recommended therapies to reduce risk of kidney disease progression, HHF, and death in clinical practice. -

Janssen Pharmaceuticals, Inc - U.S. Food and Drug Administration (FDA) approved INVOKANA™ (canagliflozin) for the treatment of adults with type 2 diabetes.

[wan] 05/10/2022 10:46

I note that the Renalytix Presentation is now available for the Texas Diabetes Council (TDC) Agenda
October 13, 2022 - 1:00 pm -

Presentation - CKD and Type 2 Diabetes:
Early Risk Assessment
Allison Trucillo, MD
Vice President, Medical Affairs -

[mikemine1] 28/9/2022 15:40

McCullough alluded to quarterly revenue reports in his last interview so, by my reckoning, we are due some sort of update shortly.

There must some big players out there who would love to get their hands on the IP by partnership or outright purchase and James more or less said so in that interview.

Wait and see is the order of the day.

[tradertrev] 28/9/2022 13:50

wan, while I appreciate your efforts to inform readers about this company and its product, at this stage food for thought isn't really what's needed. We need revenue, and fast!

[wan] 28/9/2022 11:04

I forgot to include that earlier this year in post 1785 I highlighted that Dr. Nadkarni, co-founder of Renalytix, stated the following -

Eventually, we want to add biomarkers that will expand the prognostic capabilities of the test beyond the realm of DKD, says Dr. Nadkarni, who adds that a non-diabetic version of KidneyIntelX is in the works that will include the apolipoprotein L1 (APOL1) genotype. In the meantime, our goal is to continue generating the necessary data to make KidneyIntelX the standard of care for risk assessment in CKD nationally and internationally.

So, it would appear that APOL1 is very likely to be included in the Intelx test.

[wan] 28/9/2022 10:31

Food for thought -

Sept. 27, 2022 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) today launched its new APOL1 campaign, which aims to educate and increase awareness about APOL1-mediated kidney disease, a spectrum of kidney diseases that is associated with mutations or variants in the apolipoprotein L1 (APOL1) gene and are linked to an increased risk for kidney disease in people of African and Caribbean descent. AKF’s new educational materials were developed with support from Vertex Pharmaceuticals Inc.


We know that KidneyIntelX includes APOL1 when available from past discussions, and it's included within the Centers for Medicare & Medicaid Services CPT code description -

Nephrology (chronic kidney disease), multiplex
electrochemiluminescent immunoassay (ECLIA) of tumor necrosis
factor receptor 1A, receptor superfamily 2 (TNFR1, TNFR2), and
kidney injury molecule-1 (KIM-1) combined with longitudinal
clinical data, including APOL1 genotype if available, and plasma
(isolated fresh or frozen), algorithm reported as probability score
for rapid kidney function decline (RKFD)

Plus I note that KidneyIntelX pipeline includes the following -

intelX.community

Black American adults have a higher incidence of chronic kidney disease, partially due to genetic makeup. This test seeks to provide clinicians with the ability to reliably, simply and confidently identify those select, non-diabetic patients with this ancestry, who are at higher vs lower risk for kidney disease progression to treat accordingly.
(scroll down in the following link)

It's interesting that the Intelx test for 'non-diabetic' patients has been separated out. Perhaps due to interest from those working in that specific area such as Vertex Pharma, who's most advanced clinical trial regrading APOL1 is aimed at treating the underlying cause of APOL1-mediated kidney disease, and also has an 'exclusion' criteria of the diagnosis of diabetes mellitus -

[mikemine1] 20/9/2022 11:01

If you look at McCullough in action, it's obvious that he can enthuse people and sell a product. I have no doubt, but no knowledge, that he will be talking to all sorts of potential partners and i reckon they would be very interested in talking to him, So I agree with your last sentence.

I don't think people realise how RENX and VRCI are changing the whole emphasis of testing, going away from a rather blunt instrument to finely tuned tests that will be focused on the individuals characteristics. Personalised medicine in other words and it's only just started.. Lots of companies will feel left behind and some will be clamouring to ally with these 2 to catch up quickly. When the penny drops we'll see plenty of action IMHO.

[wan] 18/9/2022 13:14

Thanks Mike.

I am not suggesting that a large pharma would necessarily provide KidneyIntelX for free, as clearly Renalytix has and is already securing private insurance coverage contracts effectively demonstrating the market is willing to pay for innovative prognostic testing, but the above effectively demonstrates pharma's interest in accessing a platform that directs and supports the potential use of certain drugs, or even differentiates their drugs from competitors.

Arguably an exclusive agreement might give pharma a significant advantage, especially if the planned expansion of kidneyIntelX also aligned with the pharma's focus/pipeline.

Given the access to potentially millions of patients, I wouldn't assume that all existing tests that come in at a more established stage of a disease will quickly become obsolete, as some will also likely augment the prognosis provided by KidneyIntelX. Plus I would not exclude later versions of KidneIntelX expanding the range of biomarkers used, including biomarkers developed by diagnostic players. Perhaps then, hence the apparent interest in KideneyIntelX also coming from diagnostic players.

It could result in a singular multiple-partner partnership (integrated kidney care/dialysis eg Davita, pharma eg AZ/Janssen/Bayer, and large diagnostic players), or a multiple of singular partnerships.

[mikemine1] 18/9/2022 11:16

Despite your last points, I didn't immediately see any relevance to RENX. It was more for the Trellus BB but you had already posted there. Reading it again, I see why you posted it here.

The importance of early diagnosis, or at least warning signs, shouldn't need re-stating but it does it seems. Early detection of problems by tests are often critical and are what clinicians are always desperately seeking, KidneyintelX just one of the new breed now joined by CDPATH. Older tests that come in at a more established stage of a disease will quickly become obsolete and discarded, leaving the companies that own them having a bare cupboard and exposed. They will be forced in to collaboration or ownership of the likes of RENX and Takeda just to stay in the game.

The point about Big Pharma's paying for the test is well spotted. This could be used whilst waiting for the insurance companies to agree to pay for the tests. Fortunately RENX have gone beyond this and have multiple agreements with insurance companies and institutions to pay for the tests which are now being increasingly used by clinicians. RENX are focusing on 3 key geographical areas where the insurance coverage is the most concentrated and it'll be interesting to hear of their progress there. The lack of FDA approval is no hindrance to RENX's ability sell to, promote within or infiltrate the medical establishment. A point vehemently made by McCullough in the last video.

I know you know all this but I thought I'd put it down here to clarify my thoughts and perhaps remind others of the enormity of what RENX has in the field of Renal medicine. They need another 6-9 months to really established themselves as what they should be IMHO but, in the meantime, their quarterly updates should show increasing revenue and penetration of the market. The market will not be able to ignore that.It's more or less what McCullough said.

[wan] 18/9/2022 10:16

Context - Gastroenterology is a key (top) business area for Takeda, with recently reported revenues of $1.8bn (270.4 billion yen) in their recent first quarter results -


Gastroenterology includes the management of inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis.

Clearly Takeda Pharmaceutical Company is not getting the following prognostic test, that identifies patients before they have severe Crohn's disease and inform discussions with patients about the management of disease, for free per se, but of course it will no doubt recommend certain treatments and medicines etc -

September 14, 2022

Prometheus Laboratories Announces Partnership with Takeda to Launch CDPATH™, a Personalized Prognostic Tool Advancing Innovation for Crohn’s Disease Patients

SAN DIEGO, Sept. 14, 2022 /PRNewswire/ -- Prometheus Laboratories Inc. ("Prometheus") today announced its partnership with Takeda Pharmaceutical Company Limited ("Takeda") to nationally launch CDPATH, an innovative prognostic tool for Crohn's disease (CD) patients. CDPATH is a personalized risk assessment tool that can be used in combination with a physician's clinical assessment to evaluate an adult patient's risk for developing serious complications of CD such as bowel strictures, internal penetrating disease, or non-perianal surgery within three years.

The CDPATH test is a result of a collaboration among Prometheus, MiTest Health LLC ("MiTest") and Takeda Pharmaceutical Company Limited ("Takeda"). MiTest defined and established the clinical relevance of the CDPATH model through an independent clinical study. Prometheus, a CLIA certified and CAP accredited laboratory, validated CDPATH and is the processing laboratory for the CDPATH program. Takeda will make CDPATH available for use by US-based physicians and offer the test free of charge to eligible patients, with the goal of supporting shared decision-making between patients and healthcare providers.

"This tool was developed to address a significant unmet need in the management of Crohn's disease," said Dr. Marla Dubinsky, who along with being a Co-inventor and Co-founder of MiTest Health, is also a Professor of Pediatrics and Medicine at the Icahn School of Medicine, Chief of Division of Pediatric Gastroenterology and Co-director of the Mount Sinai Susan and Leonard Feinstein IBD Clinical Center. "With CDPATH, we want to identify patients before they have severe disease and inform discussions with patients about the management of disease."

This partnership with Takeda, a pharmaceutical industry leader in the field of gastroenterology (GI), contributes to the Prometheus mission of enabling precision-guided patient care and improving disease outcomes.

Mike Walther, President of Prometheus Laboratories commented, "We are pleased to partner with Takeda to make CDPATH available to healthcare providers and their patients. Supporting the launch of CDPATH is yet another milestone among our strategic initiatives as we continue to provide innovative clinical lab services to guide care from disease interception through therapeutic optimization and monitoring."
Full release -

In short - Based on the results, the tool will create a patient-friendly graphical risk score. Health care providers will then receive a report that can facilitate discussions with patients to determine an appropriate course of action.


In my view it represents an interesting and innovative development, whereby the cost of the test is clearly being covered by a large pharmaceutical company. However, what's perhaps more interesting (aside from the Mount Sinai connections), is that the size of the opportunity to address chronic kidney disease by also providing early prognoses with actionable, segmented treatment insights is (unfortunately) far more urgent and indeed very much larger, as recognized by the FDA with with granting KidneyIntelX Breakthrough Designation.

[mikemine1] 16/9/2022 15:36

You got your shares at a good price vaston. Well done.

[vaston] 16/9/2022 12:58

When will I breakeven though at £3.11 a share ?

[mikemine1] 15/9/2022 12:48

In the video, James was asked about raising more cash. This is always a tricky one for investors as it usually means dilution. Unfortunately this is a perennial problem for small companies at this stage of their evolution.

There is big difference between what RENX want the money for, "straight in to marketing and sales" said the CEO, rather than just keeping the lights on. Conserving cash here is restricting growth opportunities but RENX are being realistic. Growth will be slower but , when they've sorted out all the glitches for commercialisation, and there maybe a few left, they will be in a strong position to accelerate growth quickly financed out of increasing revenue.

It's a crp market for lots of companies and not just in the healthcare sector. Things can change rapidly however so patience is very much needed for PIs and not just with RENX.

[mikemine1] 15/9/2022 12:25

It's what it's all about Wan. If anybody is in contact with any renal doctors, ask them if they would like a tool like this.

[wan] 15/9/2022 12:21

I thought the following quote from the new website was interesting -

Amit Sharma, MD, FASN
U.S. Vice President Cardiovascular & Renal, Medical Affairs at Bayer Pharmaceuticals
Board of directors, Kidney Health Initiative
National Kidney Foundation’s Patient Network and National Leadership Council

“Now, we have biomarkers and clinical features, that when combined with iterative machine learning, enable risk prediction formulas that give doctors the key answers needed: who is at highest risk vs not and what is the appropriate course of treatment.

This is critical, since we only have approximately 15 minutes with each patient. We need to be able to quickly review data and make an informed action plan. This risk prediction “score” will enable us to focus more resources on those who need it most and enable us to prescribe the best therapeutic.”

[mikemine1] 15/9/2022 11:52

Very good interview which should leave investors in no doubt as to where RENX is and going. FDA approval seems to be having less and less relevance as RENX can get paid by insurance companies etc. The next 6-9 months will be transformative IMHO. Adoption and revenue will increase. RENX is on the cusp of something great as a business and for the better treatment of patients. At the price, it's a steal IMHO. We'll see.

[vaston] 15/9/2022 08:24

I’m so Glad I paid £3 a share earlier in the year , after being tipped this will be big.