Renalytix Share Discussion Threads

[1jat] 10/7/2023 18:21

Fund raise or partner payments/investment what will the future funding be?

[charlieej] 10/7/2023 08:11

Op opinion pro pip pop

[wan] 10/7/2023 07:48

The following is the condensed version!

Perhaps also underappreciated, is the potential from the opportunity in the application and utilisation of KindeyIntelX in patient stratification and enrichment in clinical trials, especially as it's already considered that patient stratification can be significantly enhanced by Data Science, Artificial Intelligence, and Machine Learning.

As an example, Thermo Fishers expansion in this area exemplifies the level of demand and the growth prospects from clinical trial services, and tracking the care patients receive and the outcomes from their treatment -

“There is strong market demand for real-world evidence which improves decision making and reduces the time and cost associated with drug development,” Thermo Fisher Chairman, President, and CEO Marc Casper said in a prepared statement. “As the trusted partner, we continue to further differentiate our capabilities to help our customers accelerate innovation and drive productivity.”

Thermo Fisher said CorEvitas is expected to generate about $123 million in revenue this year. It will become part of Laboratory Products and Biopharma Services, the largest of Thermo Fisher’s four business segments with $22.5 billion in revenue last year, according to the company’s 2022 annual report. That’s the same unit that added diagnostic testing company The Binding Site in a $2.6 billion deal that closed at the start of 2023. Thermo Fisher expects the CorEvitas acquisition will close by the end of this year.

Full story -


A reminder from 2022 -

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.


To summarise, data-driven approaches that can use patient history from electronic health records (EHR), Real-World Data (RWD), and Real-World Evidence (RWE), combined with diagnostics and screening techniques and which include machine learning and artificial intelligence will significantly improve stratification methods and techniques, ultimately improving the outcomes for patients (and pharma).

And again, to highlight the growth opportunity: it is expected that at least 50% of all new drug approvals will use patient stratification by 2025. The rise of digital health technologies is further supporting the growth of patient stratification. Wearables and other medical devices that can collect data on patients in real-time will enable researchers to gather more detailed information and stratify patients more accurately, thus improving the chances of success in clinical trials -

Patient Stratification // Revolutionizing Clinical Trials
June 20, 2023

[wantage] 07/7/2023 17:44

Thanks Wan. You're doing a great job

[wan] 07/7/2023 12:12

To put a bit more meat on the bone and to provide further food for thought in terms of the potential beyond the current version -

Utilising the KidneyIntelX platform technology, KidneyIntelX.dkx received FDA De Novo approval. Obviously, this now means that KidnIntelX,dkd (that has a wide moat) is now considered by the FDA as a medical device that may be legally marketed in the U.S, but additionally it can be used as a point of comparison for new medical devices (again cue the wide moat) seeking approval through FDA's 510(k) premarket clearance pathway.

In other words, KidneyIntelX is now considered by the FDA as a predicate device for other 510(k) submissions, which is a less demanding and time-consuming pathway than De Novo. Furthermore, Renalytix has acquired a deep level of experience from working with the FDA during the De Novo process, which could also be deemed as an additional attraction by potential strategic partners e.g. pharma.

Readers will no doubt get the drift in terms of the potential from the platform aspect, and indeed the potential for different versions (including potentially fast-tracked delivery of such, i.e. 'initially' as a LDT), not to mention the utilisation of AI and ML to translate complex disease drivers into actionable, guideline-recommended care path for both the physician and the patient.

Therein lies another aspect to the rationale and potential for pending/future strategic partnerships.

[wan] 07/7/2023 07:46

Strictly in my opinion. If the executives deliver on the potential i.e. not just the current version of KidneyIntelX, but other versions and markets, then I don't begrudge the award of stock options, as the execution of such would likely result in a share price many times that of todays.

Readers should conduct their own research when making investment decisions.

[faz] 07/7/2023 07:36

Normally stock options are granted to incentivise staff to achieve goals. Not with RENX. THey have just served out 2m options to the Board and the exercise price is the same as the current share price. And they vest in stages from three months time. An AIM stock of course.

[wan] 07/7/2023 07:32

Again staying with the huge potential from the expansion of the platform beyond the current version -

Renalytix’s De Novo Authorization For KidneyIntelX.dkd Paves Way To Other Markets, Channels
06 Jul 2023

Executive Summary
Renalytix president Tom Mclain outlined the company’s commercial strategy for its AI-powered blood test to detect early-stage kidney disease in patients with diabetes.

Key Takeaways. The company expand its sales force into key territories and in three channels – health system partnerships, payer collaborations and direct-to-primary care practices. De novo authorization for KidneyIntelX.dkd will open more doors with payors and could expand into other disease areas.

[wan] 07/7/2023 07:27

Staying with the platform aspect (and more) -

Renalytix scores long-awaited FDA de novo nod for AI-powered kidney disease test
By Andrea ParkJul 6, 2023

The test is currently aimed at predicting declining kidney function in people with Type 2 diabetes and early-stage chronic kidney disease, but McCullough suggested in the announcement that the newly bestowed FDA clearance could open new doors for Renalytix’s technology.

“With this approval, a new class, ‘Prognostic Test for Assessment of Chronic Kidney Disease Progression,’ has been established by the FDA, providing a roadmap for future expansion of KidneyIntelX into new indications and products,” the CEO said.

Full article -

[wan] 07/7/2023 07:23

I note todays update regarding KidneyIntelX evidence presented at ADA.

Something that I have highlighted before, the platform aspect of KidneyIntelX (which I believe maybe underappreciated) , appears to be gaining traction in terms commentary. For example the inclusion of additional biomarkers/assays, in this case developed utilising the 'platform'. From todays RNS -

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.

Commenting on the data releases at the American Diabetes Association 83(rd) Scientific Sessions, Dr. Michael Donovan, Chief Medical Officer at Renalytix adds, "We are at an important inflection point in the overall understanding and management of kidney disease progression in the type 2 diabetic patient population. Precision based tools such as the KidneyIntelX assay provide a patient-level biological assessment of (DKD) disease potential for which population-based algorithms based on standard clinical variables will never be able to achieve."
(END)

That final comment/sentence actually says a lot about the Renalytix moat and degree of development achieved. And the platform aspect/potential takes the potential to another level altogether.

[mr roper] 01/7/2023 17:41

Polx had zero sales strategy from memory.
Renx at least have 50000 test candidates at Mt sinai alone and a sales force in the State.

[bertiebingo] 01/7/2023 17:06

Added small amount. If cap raise is done over the weekend it could well move to another level before consolidating. Believe in the LT story and trying to pick a points to add are going to be tough. I didn't say it will collapse, just that others have (admittedly not all) notably Polarean where FDA was a false dawn for investors.

[mr roper] 01/7/2023 15:25

Makes you wonder why you'd be buying the stock on Friday if you're expecting it to collapse...

Wouldn't it make more sense to wait until you've got sight of the path to grow revenue?

[bertiebingo] 01/7/2023 14:53

I have seen others receive FDA approval , shares spike then collapse. Important to translate this approval into $$$ asap

[mr roper] 01/7/2023 10:09

I wouldn't be surprised to see a partnership with someone like AZN who were already working with or Da Vita. They could easily take a chunk of the company while providing funding and an established sales network to ramp up the revenue growth.

Either way, we have the fda stamp of approval so it's up from here

[bertiebingo] 01/7/2023 09:57

I added on Friday but would expect the share price to consolidate / fall. It needs a) issuance of new equity to be completed, b) report results showing the conversion of the technology to revenues. New issuance is likely be completed very quickly as the CEO told me a couple of months ago that they were fully focused on getting this in place before the FDA confirmation. I think they be looking for more capital from Tony James. The real upside will, of course, be operational execution.

[iceagefarmer] 01/7/2023 08:06

Renalytix Plc (RNLX)
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2.9200+0.8900 (+43.84%)
At close: June 30 04:00PM EDT
3.1300 +0.21 (+7.19%)
After hours: 07:59PM EDT

interestingly the volume was 32 million

[iceagefarmer] 30/6/2023 19:58

200p by next friday

[iceagefarmer] 30/6/2023 19:58

after hours 40,000 buy...biggest of the day

[1jat] 30/6/2023 15:32

V volatile today….
Day traders now unwinding earlier positions and maybe taking short positions?
This will settle down…in a week or so.

[hsdeo] 30/6/2023 15:26

anyone think that this tech maybe bought up by someone