Renalytix Share Discussion Threads

[wan] 03/10/2023 08:24

Personally speaking, I don't understand the excitement via the share price reaction to what looks like predominantly recycled news.

[firestarter1] 03/10/2023 08:18

The fda was already known aboutThe 950 price was already known about

[deanmatlazin] 03/10/2023 08:13

I can't believe market didn't wake up to this great news

Better than PSA test from OBD

[deanmatlazin] 03/10/2023 08:10

$950 per test. Wow.

This will be multimillions revenue income.

[videologic] 29/9/2023 15:00

Since 12noon they are all buys. Bought another 5k. In my opinion grossly oversold, especially now we have FDA approval.

[1jat] 28/9/2023 08:29

HMG…..on any number of cases
HS2
Asylum seekers
DEI jobs

[wan] 15/9/2023 13:07

Although a landmark clinical trial in 2022 assessing the benefits of administering canagliflozin, an SGLT2 inhibitor, among patients with type 2 diabetes mellitus demonstrated benefits for repeat testing utilising KidneyIntelX, yet despite that indicated benefit, the FDA indication for KidneyIntelX is for a one-time baseline risk assessment, which doesn't get talked about much!

[wan] 12/9/2023 12:41

As my cryptic post above has been deciphered on Discord in the US -

I wondered how long it would take 😀 especially the fact that both have been included in the KDIGO 2023 Guideline (which I noted by following up on the August RNS). I also mentioned that there is a connection between founders. Also bear in mind that Klinrisk does not appear to predict progression of diabetic kidney disease, so the two should be compatible/useful. It may of course fit in with the strategic partnering discussions, and in this regard I note that Klinrisk highlight supportive relationships with AstraZeneca, Bayer, and Janssen.



Girish N. Nadkarni, Renalytix Co—founder and Navdeep Tangri, Kilnrisk founder, listed in this recent paper 2023-09-12 -

[wan] 11/9/2023 16:10

1jat, Interesting as it maybe is, clearly the recent price action would imply all the talk about strategic partnering is cryptic..........................or maybe not!

Something factual (and cryptic).....Renalytix owns the trademark rights to 'Well Filtered™' in the US, EU and UK. Yet I note the use and direction to Well Filtered™ elsewhere and beyond Renalytix/KidneyIntelX with regard to generating a risk score for patients with CKD utilising a machine learning algorithm (where I also note another connection between the founder and a Renalyix founder).

[1jat] 11/9/2023 14:28

Wan thank you for all this insight it really is interesting, but these early stage companies continue to need cash and accidents can befall the, before shareholders realise the potential returns.

My major concern here is that management and current major shareholders engineer a pre-pack administration and take all the IP into a new organisation with zero left for other shareholders or the next funding round is so dilutive it has a similar effect.

It seems current minor shareholders are reliant on the kindness of strangers to protect their interests. Until funding us clearly available through to break even I am reluctant to add to my holding (which is small at a few thousand shares and something I am prepared to risk for a multiple return).

[wan] 07/9/2023 04:38

A couple of weeks ago (21st Aug) I posted the following from a Podcast/interview - CEO, James McCullough: The critical near-term milestone for us is driving adoption. We are engaged in education programs. We have a number of strategic partnership discussions going on right now for players who are interested and can contribute to entering into the diabetes management space and a chronic disease management space. Our real short-term objective is now that we have an FDA authorized test with great outcomes data, reimbursable by insurance, is to build our commercial sales and marketing reach.

The CEO has since stated in another article that Renalytix has also seen a "substantial increase" in interest from potential commercial partners in both the US and abroad. Commercial partners and strategic partnerships that can contribute to entering the diabetes management market, which is a very large market, does appear to imply that we may get answers to perhaps more than just the funding question.

[wan] 05/9/2023 08:25

One assumes that FDA approval certainly helps (if not endorses) the prospects of taking Renalytix into the realm of enrichment strategies for clinical trials. FDA Guidance in this regard is also encouraging -

Enrichment Strategies for
Clinical Trials to Support
Determination of
Effectiveness of Human Drugs
and Biological Products
Guidance for Industry

BACKGROUND
Sponsors of investigational drug products use a variety of strategies to enrich the study population by selecting a subset of patients in which the potential effect of a drug can more readily be demonstrated.

Three broad categories of enrichment strategies as listed below are addressed in this guidance:

(1) Strategies to decrease variability — These include choosing patients with baseline measurements of a disease or a biomarker characterizing the disease in a narrow range (decreased interpatient variability) and excluding patients whose disease or symptoms improve spontaneously or whose measurements are highly variable (decreased intrapatient variability). The decreased variability provided by these strategies would increase study power (see section III., Decreasing Variability).

(2) Prognostic enrichment strategies — These include choosing patients with a greater likelihood of having a disease-related endpoint event (for event-driven studies) or a substantial worsening in condition (for continuous measurement endpoints) (see section IV., Prognostic Enrichment Strategies — Identifying High-Risk Patients). These strategies would increase the absolute effect difference between groups but would not be expected to alter relative effect.

(3) Predictive enrichment strategies — These include choosing patients who are more likely to respond to the drug treatment than other patients with the condition being treated. Such selection can lead to a larger effect size (both absolute and relative) and can permit use of a smaller study population. Selection of patients could be based on a specific aspect of a patient’s physiology, a biomarker, or a disease characteristic that is related in some manner to the study drug’s mechanism. Patient selection could also be empiric (e.g., the patient has previously appeared to respond to a drug in the same class) (see section V., Predictive Enrichment — Identifying More-Responsive Patients).

[wan] 05/9/2023 07:59

The increasing inbound enquiries from potential commercial partners, suggests that KidneyIntelX has come onto a range of new radars. In my view, strategic partnering is more likely in terms of near-term news flow.

Not least from the recognition that Renalytix has the keys to a 'platform technology' that can deploy a range of biomarkers, including those from certain institutions, such as Joslin, and diagnostic players, with potential to further differentiate and significantly expand the range of indicated uses.

In my view, there is also potential for the application and utilisation of KindeyIntelX in patient stratification and enrichment in clinical trials (for instance patients may be stratified by stage), especially as it's already considered that patient stratification can be significantly enhanced by 'certain biomarkers', Data Science, Artificial Intelligence, and Machine Learning.

So, it's perhaps worth considering recent deal making activity as indicative of the demand and growth potential on offer. In this regard, Thermo's expansion in this area exemplifies the demand and the growth prospects from clinical trial services, monitoring Real-World-Evidence and tracking the care patients receive and the outcomes from their pharmaceutical treatments -

“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.

[donald pond] 05/9/2023 05:46

I can't help but feel we are getting close to the endgame here. Valuation is so low that if RENX can deliver a fraction of what the potential appears to be someone is going to buy them out soon. So the question is whether RENX can deliver, and whether the potential is what we think.
I know they have FDA approval, but it doesn't feel as if there has been much take up since the CEO was talking about how revenues could jump from zero to hundreds of millions overnight, and IIRC that was in a podcast during covid lockdown.

[mikemine1] 01/9/2023 09:14

No wonder the big boys are looking at RENX. I can't imagine how big this could be or how important this could be for the future of patient care.

[wan] 01/9/2023 04:45

Insightful coverage, excerpts follow -

Renalytix Ramps up Commercialization Efforts for Kidney Disease Test After FDA Approval
Aug 31, 2023

Since receiving FDA approval, Renalytix has also seen a "substantial increase" in interest from potential commercial partners in both the US and abroad, McCullough said. The firm already has a distribution partnership in place with Vector Pharma in the Middle East, and McCullough noted that having FDA approval should help the company garner regulatory approval globally. Renalytix has begun seeking such approvals, he added, although 90 percent of its focus is on the US market.

Renalytix has multiple plans for broadening its test beyond its original indication. Along with building data for the current indicated use of the test, the company is also looking into new biomarkers and improvements in its algorithm to further boost performance of the assay and expand its indicated use. The firm focused on patients with diabetes first "because they tend to have the biggest contribution to uncontrolled progression of kidney disease," McCullough said.

But now that it understands the FDA process and has approval, Renalytix is also investigating potential new components, such as cardiovascular markers, and applying the test to other populations. The firm is involved with a variety of research projects surrounding new biomarkers and is determining how new biomarkers can best be deployed in different use cases, he said.

It is also interested in measuring therapeutic response and providing an "accurate gateway to understand who should get what drugs," he added.

Ultimately, the company's goal is to reach a point where its test is able to "understand not only the risk for progression but the characterization of that disease," including therapeutic response and mechanism of action, he said.

Full article worth reading -

[wan] 24/8/2023 13:35

Renalytix reported in Q3 that "Local Coverage Determinations (LCD) are being progressed with two Medicare Administrative Contractors supported by new published real-world utility evidence"

Again FDA approval means that KidneyIntelX has already undergone an independent, rigorous scientific process, so that's sure to help matters too.

[wan] 24/8/2023 13:19

In answer to a question regarding todays meeting; "Do you know approximately when the outcome will be known?" on Discord in the US -

I am not exactly sure, but I note that "Once the proposed LCD is published, MACs provide at least 45-days in which the public may provide written comments." You can find the following, and a lot more in the links that follow -

The purpose of the CAC is to provide a formal mechanism for healthcare professionals to be informed of the evidence used in developing the LCD and promote communications between the MAC and the healthcare community. CAC members should serve in an advisory capacity as representatives of their constituency to review the quality of the evidence used in the development of an LCD. The CAC is advisory in nature, with the final decision on all issues resting with MACs. Accordingly, the advice rendered by the CAC is most useful when it results from a process of full scientific inquiry and thoughtful discussion with careful framing of recommendations and clear identification of the basis of those recommendations.

[mikemine1] 23/8/2023 17:16

Well done wan. I don't know how you find all this nor how you find what links it all together. I couldn't do it.

As mentioned, payment have been going on for a while. I wonder how the revenue stream is growing.

[wan] 23/8/2023 13:18

Edited message to 'tomorrow', got ahead of myself!

[wan] 23/8/2023 08:34

Recall that previously the National Government Services (NGS) initiated payment of claims for KidneyIntelX testing for patients with Medicare coverage that have met appropriate medical necessity criteria.

Effective July 1, 2022, claims for KidneyIntelX tests have been processed and paid by NGS using the ICR process. Under this payment methodology, NGS reviews each claim to determine its medical necessity based on the clinical evidence supporting its intended use. Payment timelines are within Medicare's 30-day targeted timeframe for payment.


And note that at that time KidneyIntelX did not have FDA approval, which it of course now has.

A reminder that tommorow there is the following NGS Contract Advisory Committee (CAC) meeting regarding KidneyIntelX Test scheduled for August 24, 2023. The CAC advises and consults to review Local Coverage Determinations -


On top of the fact that KidneyIntelX now has FDA approval, and that substantial supportive clinical study data has since been reported, including recently -

Four new data presentations, including late breaking clinical study data, underscores the value of KidneyIntelX testing in helping slow progression of chronic kidney disease in type 2 diabetes patients


Not to mention Renalytix 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


The fact that these CAC meetings usually include presentations of comparative utilisation data, along with other evidence used in developing an LCD (one assumes that could include substantive supporting clinical study data), hopefully then the outcome will be a positive one.

[wan] 21/8/2023 11:44

An interesting recent podcast with James McCullough, a couple of excerpts follow -

Welcome to the Empowered Patient Podcast with Karen Jagoda. This show is a window into the latest innovations in digital health and the changing dynamic between doctors and patients.

James McCullough: KidneyIntelX is the in vitro prognostic, which we just got FDA approval on and is now reimbursed by several major insurance companies. Medicare also pays for it. We have a unique opportunity to go in and start to practice a much higher level of preventative medicine by understanding who is at high risk early.

James McCullough: For KidneyIntelX version one, which was just authorized out of the Food and Drug Administration on a de novo marketing authorization through
Breakthrough Device designation, we are looking at adults with type 2 diabetes
and early-stage kidney disease, which is defined as early as stage 1. These are
early-stage patients with diagnosed kidney disease. They have diabetes, and
now the real issue is where they stand in the risk spectrum of progressing. We
are actively working on new test versions where we can add additional protein
biomarkers, genetics, and electronic medical record features.

One of the big advantages of KidneyIntelX is that it runs off of a non-linear
artificial intelligence-enabled algorithm that can ingest more and more
information—there is really no limit. We can then turn around and validate that
algorithmic result against a specific outcome, so we can start to expand the
indicated uses of KidneyIntelX.

James McCullough: The critical near-term milestone for us is driving adoption. We are engaged in education programs. We have a number of strategic partnership discussions going on right now for players who are interested and can contribute to
entering into the diabetes management space and a chronic disease management space. Our real short-term objective is now that we have an FDA authorized test with great outcomes data, reimbursable by insurance, is to build our commercial sales and marketing reach.

The goal is now to make KidneyIntelX testing as ubiquitous as possible to diabetic kidney disease patients in the United States through multiple channels, including hospital system partnerships, insurance companies, and other strategic partnerships. Insurance companies, particularly Medicare and Medicaid, are struggling to control the cost around diabetic kidney disease. We're deploying a direct sales force now with customer service and medical science liaison support to support messaging directly to primary care physicians

Full transcript -

[mrmarmalade] 21/8/2023 08:00

Agreed...along with the recent Middle East Agreement...all good.