Renalytix Share Discussion Threads

[toffeeman] 01/7/2021 22:09

Crikey - she wasn't old how tragic

[mr roper] 01/7/2021 20:50

Very sad news indeed.

[wan] 01/7/2021 17:19

Very sad news today with the announced loss of such a passionate, well liked and inspirational Non-Executive Director. I am sure her legacy will continue to positively impact numerous aspects of kidney care and benefit many patients for many years beyond her untimely death.

I extend my sympathies accordingly.

RIP Dr Barbara Murphy.

[wan] 29/6/2021 08:20

Renalytix gets several mentions in the following interview, with an important point regarding the relationship with Mount Sinai that gives Renalytix an advantage not normally available to most medical businesses, which has already assisted on-boarding of health systems, but combined with Renalytix expertise, including the new and expanding team, will accelerate the on-boarding process (from 25 mins in) -

[wan] 28/6/2021 17:55

Dontshoutatonce...The market has taken news of the Director share sales and the sales themselves (17k, 15k and 6K) in its stride, with some lumpy sells and buys significantly above those values also taking place during the same period. The directors have acknowledged/supported at least some of that demand (plus they have limited windows to sell into, so it's good that demand is there).

That aside, Renalytix has stated that the pace of milestone events is to continue into the first half of fiscal 2022 beginning this calendar July, including the strong possibility of FDA clearance. So, in my view, there is some positioning taking place ahead of this important period.

[dontshoutatonce] 28/6/2021 16:46

wan, just out of interest, why would the chairman selling (a very tiny fraction of his shares) make you think that there is solid interest? I am very confident of this company's fabulous future but I'm interested in your idea.

[wan] 28/6/2021 16:37

I note the Chairman let another 6100 shares go last Friday.

And thus I still think there is solid interest and good underlying demand for the stock ahead of certain inflection points, culminating in what looks set to be a pivotal 6-7 month period for Renalytix.

[wan] 28/6/2021 09:38

I also note AstraZeneca's SGLT2 news today -

Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease
PUBLISHED
28 June 2021

28 June 2021 07:05 BST

If approved, Forxiga has the potential to change the treatment paradigm for millions of people in the EU suffering from chronic kidney disease

AstraZeneca’s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DAPA-CKD Phase III trial that showed Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of the composite of worsening of renal function, end-stage kidney disease (ESKD) and cardiovascular (CV) or renal death, compared to placebo.

Forxiga also significantly reduced the risk of death from any cause, compared to placebo. In the trial, the safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.

CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke.1-3 It affects approximately 47 million people in the EU and nearly 840 million people worldwide.3,4 However, diagnosis rates remain low and up to 90% of patients are unaware they have the disease.5

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The unprecedented results of the DAPA-CKD Phase III trial show that Forxiga can significantly slow the decline of kidney function and reduce the risk of death for patients with chronic kidney disease. This positive CHMP opinion underscores Forxiga’s potential to transform the future care of chronic kidney disease and brings us one step closer to providing a much-needed new treatment option to millions of patients in the EU.”

Forxiga (known as Farxiga in the US) was recently approved in the US for the treatment of CKD in adults with and without T2D and, in addition to the EU, is currently under review in Japan and other countries around the world. Forxiga is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D and for the treatment of symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults with and without T2D.

Forxiga
Forxiga (dapagliflozin) is a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor. The research for Forxiga is advancing from cardiorenal effects to prevention and organ protection as science continues to identify the underlying links between the heart, kidneys and pancreas. Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, including T2D, HF and CKD.

[donald pond] 28/6/2021 09:37

It's obvious really but of course repeat testing is going to be key: you find out so much more through understanding how a person's results are changing rather than through a snapshot. The revenues and profits here are imo going to be huge

[wan] 28/6/2021 07:39

More good news announced today and aligning with my previous posts on my increased optimism regarding increasing inbound pharma enquiries and the potential for a significant pharma revenue line.

The following comment, which includes the phrase "repeat testing" is, in my view, instructive as to the potential for further pharma partnerships and utilisation -

Michael J. Donovan, CMO at Renalytix, said: "The ability of KidneyIntelX to assess SGLT2 inhibitor response and improvements in kidney health through repeat testing is a significant step towards broader utilization of new therapeutic agents to significantly reduce the risk of kidney failure. This is another demonstration of the unique value of the KidneyIntelX bioprognostic solution to assist in early and effective care management of the 12-15 million adults in the United States with diabetes and chronic kidney disease."

[wan] 26/6/2021 07:11

I note yesterday Renalytix issued and allotted 150,000 ordinary shares of 0.25 pence each in the share capital of the Company ("Ordinary Shares") following an exercise of options on 24 June 2021. And the sale by Fergus Fleming, CTO, of 15,000 shares at a price of 1075 pence per share.

Cardifblue...Renalytix are currently assuming that the FDA process will be complete in the second half of this 2021 calendar year, so some time between now and the end of the year.

In my view, there is solid underlying demand for the shares as Renalytix will continue to deliver over the remainder of this calendar year -

"We expect the pace of milestone events to continue into the first half of fiscal 2022 beginning in this July, including a potential FDA clearance, additional major health system partnership announcements, beginning operations in the VA medical system, increasing our portfolio of real world evidence data, particularly at the all important primary care level, potential national Medicare coverage determination, and an acceleration in KidneyIntelX testing volumes. With the recent Atrium, Wake Forest partnership and the new potential to onboard from 1,293 healthcare facilities in the Veterans Administration Medical System, we remain confident in our previous guidance of 5 to 7 announced major health system partnerships in calendar 2021."

[cardiffblue] 25/6/2021 20:52

Can I ask your latest view on when we are likely to get FDA approval? In the next month or is it longer away does anyone think?

[wan] 25/6/2021 07:51

The 81st Scientific Sessions Event by American Diabetes Association commences today June 25, 2021, 3:00 PM - Jun 29, 2021, 9:00 PM. Where the latest updates detailed below (which aligns well with my post 1213 above) will be covered in talks during the 81st ADA Scientific Sessions this weekend -

Heart Failure Studies Reflected in Updated ADA Standards
June 25, 2021
Mary Caffrey

Updates reflect the increased intersection among diabetes, cardiovascular, and kidney disease care among certain drug classes, especially sodium glucose co-transporter 2 (SGLT2) inhibitors.

Standards of care from the American Diabetes Association (ADA) were updated last week to reflect studies from the past year involving therapies that reduce hospitalization for heart failure and delayed chronic kidney disease progression, including for patients with type 2 diabetes (T2D).

Updates reflect the increased intersection among diabetes, cardiovascular, and kidney disease care among certain drug classes, especially sodium glucose co-transporter 2 (SGLT2) inhibitors. New evidence included in the section on Cardiovascular Disease and Risk Management comes from cardiovascular outcomes trials: VERTIS-CV, for ertugliflozin; EMPEROR-Reduced, for empagliflozin; and SCORED and SOLOIST-WHF, for sotagliflozin, a dual SGLT1/2 inhibitor.

Additional results for SCORED and SOLOIST will be presented Tuesday during the 81st ADA Scientific Sessions. Previous results have shown a signal in heart failure with preserved ejection fraction, a hard-to-treat condition.

The section Microvascular Complications and Foot Care was updated to feature evidence from DAPA-CKD, for dapagliflozin, and FIDELIO-CKD, for finerenone.

Robert A. Gabbay, MD, PhD, FACP, chief scientific and medical officer for the ADA, said the evidence on SGLT2 inhibitors “continues to be confirmatory and expanding. We're seeing more confirmation that SGTL2 [inhibitors] reduce both cardiovascular disease and chronic kidney disease risk.”

In recent years, the ADA has moved away from updating the Standards of Medical Care in Diabetes once a year and instead adopted a Living Standards model, with frequent updates. These latest updates will be covered in talks during the 81st ADA Scientific Sessions this weekend.

“More evidence is accumulating that this effect is probably not about glucose, or certainly not totally based on blood glucose changes, and that other important mechanisms are involved,” he said. “Part of that evidence is the fact that seeing benefit of these medications in people without diabetes, and that is an exciting, new arena and something that you'll see covered in the scientific sessions and as reflected in the living standards.”

The addition of the DAPA-CKD and FIDELIO-DKD trials show what is known about the connection between diabetes and end-stage renal disease.

“We now have more ways of controlling blood glucose and blood pressure,” and using therapy to prevent CKD, he said.

Gabbay mentioned the possibility of a new drug class the anticipation of results from the SURPASS trial, for a therapy that combines a glucagon-like peptide-1 receptor agonist (GLP-1) RA and a glucose-dependent insulinotropic polypeptide (GIP).

“That said, even in the presence of those treatments, there are a significant number of people that still develop chronic kidney disease. And diabetes continues to be the leading cause of end stage renal disease. And so, from the availability of new medications to drugs that are already out on the market, and the opportunity for a new class of drugs potentially, to come to market, I think are really quite exciting.”



And the name change reflects the changing dynamics -

KidneyIntelX. Designed to be scalable. Additional discoveries and developments in novel biomarkers, expanded clinical indications and integrated digital technologies.

Our KidneyIntelX platform is designed to scale across kidney disease conditions beyond diabetic kidney disease. We are evaluating a range of new indications in chronic kidney disease, cardio-renal disease, chronic kidney disease in diverse populations and COVID-related kidney disease. We’re also continuing our next generation work on our current diabetic kidney disease indication while we explore ways to expand access to patients around the world.

Critical to our platform is also the ability to stay at the forefront of cloud based digital health technology, data integration and data analytics, which we’re accomplishing through our newly-established Digital Health Team, various strategic partnerships and our participation in how category regulations should evolve. All of these will enable the most effective data-driven decision making and care delivery across the healthcare system and for each patient.

New indications are on the horizon with our KidneyIntelX platform:

Risk assessment and care insights for Chronic Kidney Disease

Diabetic Kidney Disease and Chronic Kidney Disease monitoring tests, beyond the initial risk assessment

[wan] 25/6/2021 07:35

I missed yesterdays RNS regarding the name change to Renalytix, which is subtle, but obviously purposeful -

Traditional clinical kidney measurements are flawed.

Physicians typically look at estimated GFR (glomerular filtration rate) and urinary albumin creatinine ratio levels, but they are inadequate in identifying those select patients who are more likely to experience progressive decline in kidney function.

That changes now… with kidney bioprognosis™.

Renalytix is the global founder and leader in the new field of bioprognosis for kidney health. We’ve engineered a new solution that successfully enables early-stage, progression risk assessment, when it counts the most.


NEW YORK, June 24, 2021 - Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) announces it has changed its name to Renalytix Plc.

The Board believes that the new name reflects the fact the Group is focused on bioprognosis for kidney health, engineering a solution that successfully enables early-stage, progression risk assessment for patients with kidney disease.

[wan] 24/6/2021 11:26

Previously, and as a consequence of the recent earnings call, I highlighted that I was also very optimistic regarding pharma partnerships given the increasing inbound pharma enquiries being received by Renalytix, and thus the expectation of a growing pharma services revenue line going forwards.

The following excerpt puts my optimism into context -

Tycho Peterson

Okay. And then last one for me just on pharma. I am curious, with the interest and then the pipeline looks beyond the AstraZeneca agreement and how far are you away from kind of recognizing pharmaceutical services as kind of a separate line item?

James McCullough

Yes. Pharma, I am glad you asked that question. Pharma for me is actually a growing area. We have again an increasing inbound interest from a number of different pharmaceutical companies large and small. I think that that is going to be very fruitful. As in general, we are entering the age of precision medicine therapeutics. With pharma, the SGLT2 inhibitors have been a phenomenal success in terms of efficacy and treatment. Everybody needs a way to stratify risk early for treatment and everybody needs a way to look at mechanism from a biomarker level at kidney disease, which is not just kidney disease, right. It’s a whole sequence of diseases. And there are different types of kidney disease and KidneyIntelX ultimately is a precision medicine in vitro diagnostic that is able to characterize the disease in many different ways. So, I think pharma is going to play a major role in KidneyIntelX development. It’s one of the reasons that we signed the broader agreement with the Joslin Diabetes Center to get a hold of such a really a prolific set of biomarkers that Andre [indiscernible] has been working on with Joslin for decades. We believe that that will play very well with new drug developments and characterizing drug response. You should expect to hear more about the canagliflozin trial that’s the SGLT2 inhibitor trial that was setup by Janssen. And of course, we now have access to that. And we are taking a look at a whole series of parameters we press released on the first one. There will be additional news coming out of that particular study with KidneyIntelX. So, pharma is again a wholly accretive effort, an area to just pulling in on-boarding systems for adoption. And I think one last thing I will say about that is what’s becoming clear is that now that we have several major systems in a geographically diverse area that are integrated. And we have access now to data flowing out of these institutions around the care pathway. None of this is comprehensive. So, we are not only looking at early risk stratification, we are looking at drug prescription. We are looking at care navigation. We are looking at clinical workflow. This is developing a very comprehensive picture around how kidney disease is managed from an early stage through the different clinical channels, and how its risk assessed. And that network should be incredibly valuable to pharma as it understands how to treat these large populations with new drugs that are rolling off. So, we do expect to have a pharma services revenue line, which is going to be growing. And obviously having AstraZeneca as a cornerstone partner, we couldn’t ask for a better partner. Their renal division is world leading and comprehensive and it expands across multiple indications.
Full transcript -

Given the SGLT2 comments, the following perhaps frames where at least some of that increasing inbound pharma interest might be coming from, as approvals and usage gathers momentum -

Farxiga faces first heart failure rival as EU OKs Boehringer/Lilly’s JardiancePhil TaylorPhil TaylorJune 22, 2021

AstraZeneca’s SGLT2 inhibitor Farxiga has been growing fast thanks to a first-in-class approval in heart failure, but will now have to share the market with Boehringer Ingelheim and Eli Lilly’s rival therapy Jardiance.

The European Commission has become the first regulator to approved Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.

Jardiance, Farxiga (dapagliflozin) and other SGLT2 drugs are already widely used to treat type 2 diabetes, and their developers have long had aspirations to expand their use into other cardiometabolic disorders, including heart failure and chronic kidney disease (CKD).

AZ stole a march on its rivals after it claimed approval for Farxiga as a treatment for HFrEF in the US in May 2020 and in Europe the following November. That helped drive sales of the drug up 30% to almost $2 billion last year, and more than 50% to $624 million in the first three months of this year.

That was followed by another first-in-class FDA approval for Farxiga in CKD in April, leaving Boehringer/Lilly playing catch-up with Jardiance once again.

Now, the approval of Jardiance for HFrEF in Europe – with an FDA decision due in the coming weeks – gives them a chance to reset the playing field. A readout in CKD from the EMPA-Kidney is expected next year.

Full story -

[wan] 24/6/2021 08:18

Edit...Link added to Summary

[wan] 24/6/2021 08:00

I am not sure how the following processes ultimately work, but apparently the following new medical research bill proposed by US lawmakers would also push through a delayed but highly anticipated CMS policy requiring payment for breakthrough devices.

The discussion draft was circulated earlier this week -

Cures 2.0: Discussion draft signals impact on FDA, creation of ARPA-H
Posted 23 June 2021 | By Michael Mezher

Cures 2.0: Discussion draft signals impact on FDA, creation of ARPA-H
More than four years after the 21st Century Cures Act was signed into law, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on Tuesday circulated a discussion draft of their proposed Cures 2.0 legislation, setting the stage for negotiations on the long-awaited legislative package.

Full story -

Summary -
21st CENTURY CURES 2.0
Discussion Draft Section-by-Section
TITLE I: PUBLIC HEALTH

Sec. 404. Coverage and Payment for Breakthrough Devices Under the Medicare Program:
working with Reps. DelBene (D-WA) and Bilirakis (R-FL) to include the Ensuring Patient Access to Critical Breakthrough Products Act. This policy would codify the current Medicare Coverage of Innovative Technology pathway at CMS.


DISCUSSION DRAFT]
117TH CONGRESS
1ST SESSION H. R. ll
To continue the acceleration of the discovery, development, and delivery of
21st century cures, and for other purposes.

[wan] 23/6/2021 10:00

Toffeeman...Yes a bargain indeed ;-) but I note the later correction to 1135p

[wan] 23/6/2021 08:09

Correction to article in post 1201 -

CORRECTION: UK NHS Grants Award to Paige, Others to Evaluate AI-Based Diagnostic Systems
Jun 21, 2021

The story has been corrected to clarify that the £36 million in total funding was awarded to several projects.

In total £36 million ($50.2 million) was awarded to "dozens of new pioneering projects to test state-of-the-art AI technology," according to a spokesperson. The amount awarded to Paige and its partners was not disclosed.

[toffeeman] 22/6/2021 12:24

I would have paid him 120 :)

[wan] 22/6/2021 11:52

I note the RNS notifying that Christopher Mills, non-executive director and interim Chairman, completed the sale of 17,000 ordinary shares at 113.5p

Following completion of the sale, Christopher Mills is interested in 9,180,501 Ordinary Shares representing 12.74% of the current issued share capital of the Company.

[wan] 22/6/2021 09:36

All in good time, you will note in the article that the award is restricted to market-authorized, CE-IVD-marked products.

Renalytix strategy to ramp the commercial team whilst also focusing on the broadest reach and access is the right one at this stage prior to expected FDA approval. CE mark can then follow and UK/European roll-out will then represent another large market/ growth opportunity.

[mr roper] 22/6/2021 09:28

Nhs would be too much to chew on just now. Best to focus on the US, get the fda approval, get the partnerships operating and start generating hard revenue.
Got to remember they only have 51 employees.

[donald pond] 22/6/2021 09:26

Probably right, in terms of market size it dwarfs everything else