Renalytix Share Discussion Threads

[supernumerary] 14/3/2023 17:11

Taken up by the media:



With billions of dollars on the line, Bayer survey finds flaws in kidney disease communication, diagnosis
By Nick Paul Taylor Mar 14, 2023 08:05am

Chronic kidney disease (CKD) should be among the top health concerns of diabetes patients. Yet, while around 1 in 3 adults with diabetes has CKD, a Bayer survey of healthcare professionals shows that people are often unprepared for their diagnosis and that communication needs to improve.

Bayer, which won approval for Kerendia in CKD associated with Type 2 diabetes in 2021, worked with market research company MedSurvey to survey 1,000 healthcare professionals (HCPs). The survey found that 84% of HCPs agree patients with Type 2 diabetes are often unprepared for their diagnosis of CKD, and that 88% of HCPs see a need for clearer and more transparent language about kidney disease risks.

The failings of current efforts to educate patients about CKD risks are clear in the survey data. Most, 89%, of the polled HCPs said people don’t understand their increased cardiovascular risk once they are diagnosed with CKD. Bayer has linked Kerendia to reduced risk of cardiovascular death.

If Bayer is to fulfill its $3 billion sales forecast for Kerendia, it will need a flow of new CKD patients. The survey suggests there is room to improve the patient pipeline, with most HCPs agreeing that the medical community could diagnose people earlier.

Sixty-two percent of primary care physicians are using estimated glomerular filtration rate blood tests to assess kidney function at least every few months. However, use of urine albumin-creatinine ratio (UACR) tests is rarer, with 30% of primary care physicians and 57% of nephrologists regularly using the tests. U.S. guidelines call UACR the easiest way to screen for albuminuria, a key factor in diagnosing CKD.

Bayer framed its generation and publication of the survey data as part of a push to improve diagnosis and ensure people receive optimal care. Establishing Kerendia as part of the go-to treatment regimen in the indication would boost Bayer’s prospects at a time when it is seeking to establish new growth drivers to offset the loss of exclusivity on its blood thinner Xarelto and eye drug Eylea.

Sales of Kerendia hit (PDF) 107 million euros ($115 million) in 2022, its first full year on the market. Bayer is going up against SGLT2 inhibitors, namely AstraZeneca’s Farxiga and Johnson & Johnson’s Invokana, and ran its first TV ad last year to support its push for market share.

[wan] 14/3/2023 15:27

I missed this late last week -

World Kidney Day: A Bayer Survey Reveals Physicians Agree on Need for Earlier Testing and Increased Transparent Communication for People Diagnosed With Chronic Kidney Disease Associated With Type 2 Diabetes

Nephrologists and primary care physicians each see their role as the lead healthcare professional in diagnosing and managing chronic kidney disease (CKD) in type 2 diabetes (T2D) patients1

Results also revealed challenges among physicians co-managing people with CKD associated with T2D1
March 09, 2023

“Research has shown that co-management between a primary care physician and a nephrologist is associated with improved quality of care, delayed dialysis and more frequent testing, but we wanted to more deeply understand some of the challenges the treatment team faced in an effort to incite conversations about how we can improve on them,” said German Guerrero, M.D., Executive Medical Director, Cardiorenal, Bayer.4 “At Bayer, we are working to ensure people with chronic kidney disease associated with type 2 diabetes receive optimal care that ultimately leads to earlier diagnosis and treatment and better outcomes.”

“These findings reinforce the importance of our commitment to identifying resources and programs aimed at better understanding the real-world management of chronic kidney disease and expanding screening and early care management,” said Dr. Guerrero. “Together—with healthcare professionals and the broader kidney community—we have an opportunity to improve the diagnosis and management of chronic kidney disease to truly advance care.”

Full release -

[wan] 14/3/2023 09:04

Food for thought -

Recall that back in May 2022 Davita and Medtronic announced the formation of joint venture forming a new kidney health technology company, with Medtronic spinning off its renal care business into the venture and each company investing $200 million into the joint venture.

"We're excited to collaborate with Medtronic and share our deep insight into patient and physician needs with the goal of accelerating the development and commercialization of scalable kidney care technologies," said Javier Rodriguez, CEO for DaVita. "DaVita is committed to best-in-class solutions that improve outcomes, access and the quality of life of our patients, and this is another way to provide more options to the market."


I note that Medtronic recently stated in their Q3 2023 Earnings Call
on Feb 21, 2023, that completing the creation of its new joint venture with DaVita will close in the current quarter, stating that "We expect to close our Renal Care joint venture with DaVita here in the fourth quarter".

According the following article, the new company is apparently going to be called Mozarc Medical(excerpts follow)-

Medtronic and DaVita’s dialysis venture appears to be called Mozarc Medical
Regulatory filings indicate a medtech CEO is involved in the new kidney care company.
MARCH 13, 2023 BY JIM HAMMERAND

Clues are pointing to Mozarc Medical as the name of the new kidney care company that Medtronic (NYSE:MDT) and DaVita (NYSE:DVA) are expected to launch this year.
The companies used “NewCo” as a placeholder when announcing the new company last year and said a renaming and rebranding would come when the deal closes sometime in 2023.

Since then, Medtronic has filed trademark applications with the U.S. Patent and Trademark Office for Mozarc and Mozarc Medical relating to dialysis products.

It’s not clear when Mozarc Medical will launch, but Medtronic’s recent voluntary early retirement package (VERP) offer specifically excluded employees who “are conveying with Mozarc Medical.” Eligible employees had until last week to accept that deal, which required retirement on or before April 28.

The Mozarc trademark applications cover a long list of goods and services:

Computer, processors, and mobile device software, algorithms, and methods used to manage, control, operate and display information from medical devices for the treatment of organ deficiencies, medical devices for renal and extra-renal therapies, medical devices for filtration of bodily fluids and plasma exchanges, dialysis machines, and blood filtering devices; machine learning both supervised and unsupervised for managing kidney prescriptions and monitoring same; cloud infrastructure and related management software to manage patient prescriptions and ordering of consumables, kits, service, and maintenance of equipment

Full article -

It will thus be interesting to see how this new company impacts the kidney health/diagnostic landscape (and not just dialysis).

[red171] 09/3/2023 16:11

I would not like to be out should any of the expectations set for delivery this quarter end materialise but am not at the stage of selling on the basis that none of them will happen.

FDA, replacement for Medicare Coverage of Innovative Technology pathway, a mass coverage tippining point causing revenue to jump ahead of $1m pQ, Mount Sinai start placing orders at higher rate, determinations, even some VA centres actually placing orders or indeed cost burn significantly reduce would all be positive enough but I presume JO Sterling CFO would have been adding to his shareholding by now if their combined impact would be a step change.

The trouble is if they have made over optimistic guidance in the past, given the prize, who can be confident that none of it happen now. Have they just been engaged in raising more capital to spend?

[hpcg] 06/3/2023 19:43

I must admit I am out again. I think at best price will consolidate for a while and the move post the placing was quite something. I'd rather buy higher when revenue traction has at least started.

[wan] 01/3/2023 08:08

Prevention being the overriding message, and increasingly being recognised as the target for real and meaningful change at the individual level.

Cue KidneyIntelX:

KidneyIntelX is a highly-reliable, bioprognostic™ methodology, that yields a simple-to-understand, custom risk score, predicting which adult patients with type 2 diabetes and with chronic kidney disease stages 1-3b are at low, intermediate or high risk for rapid progressive decline in kidney function.

When doctors combine information gathered through KidneyIntelX with newer cardio- and reno-protective therapies, they know which patients are at higher to lower risk for rapid disease progression, and therefore, can appropriately target resources and guideline-recommended treatments to advance kidney health.

[wan] 01/3/2023 07:56

March is National Kidney Month.

National Institute of Diabetes and Digestive and Kidney Diseases

As a health care professional, you can raise awareness about kidney disease and help your patients follow their kidney health. Diagnosing kidney disease earlier, and tracking progression over time, may give your patient more opportunities to slow disease progression and have more healthy moments.

Teach your patients how to protect their kidneys

Test people over age 60 and those who have risk factors for kidney disease.
Create a personalized care plan that allows you to monitor both diabetes and kidney health.
continues....

Kidney Month: A Time of Unity and Action on Behalf of 37 Million Living with Kidney Disease

American Kidney Fund encourages Americans to come together in the fight against kidney disease, provides opportunities for empowerment, education and action

A highlight of Kidney Month for the kidney community will be AKF’s Kidney Action Week, which will be held March 20-24. This nationwide online gathering brings together patients, nephrologists, renal dieticians, advocates, caregivers and other kidney experts for a free, virtual experience that will educate and empower attendees.

Kidney Action Week will include a Congressional Briefing that will highlight the need to address prevention and management of diabetes and hypertension, the two leading causes of kidney failure. Speakers include Rep. Donald Payne (D-NJ), who lives with kidney disease and diabetes.

[wan] 28/2/2023 14:48

Readers will no doubt recall Renalytix proprietary biomarkers -

Biological factors that are clinically proven – in multiple studies – to be most prognostic for kidney disease (TNFR1, TNFR2, KIM-1).

I thought the following from India was thus very interesting -

Published: February 25, 2023

Chronic Kidney Disease of Unknown Etiology in a Tertiary Care Teaching Hospital

Background
Several primary studies have looked at the burden of chronic kidney disease among diabetic patients, but their results have shown significant variance in India. In order to determine the combined prevalence of chronic kidney disease and associated risk factors among patients with diabetes, this study used a combination of methods.

Conclusion
Despite the urban centers previously being thought of as a non-endemic location, for the first time in the city, 60 CKDu patients are reported in this study. This is the first study to use the urinary biomarkers KIM-1 and NGAL to find suspected cases of CKDu and early kidney damage in local communities in the urban centers.

The proximal tubule apical membrane expresses kidney injury molecule-1 (KIM-1), a type 1 transmembrane protein, when there is kidney injury [7]. KIM-1 was demonstrated to be an exceptional predictor of histological alterations in serum creatinine and blood urea nitrogen in the proximal tubule in response to various pathophysiological circumstances or toxicants [8].

Full study details -

[videologic] 26/2/2023 18:00

7.8% up on Nasdaq on Friday.

[mr roper] 20/2/2023 15:05

Next leg up underway.

[apatel21] 20/2/2023 12:17

Continuing to show strengthNot your typical reaction to a deeply discounted placing without significant newsNow 41% above placing price

[sirshagalot] 16/2/2023 13:18

Eats steak and kidney pie

[mr roper] 14/2/2023 14:54

It's not been leaky at all

[apatel21] 14/2/2023 13:46

Share price strength here is encouraging given the price placing was done at.Normally see price head south towards placing price.I think Renx has been leaky in the past - is it therefore an indicator of some good news to come ?

[mr roper] 12/2/2023 21:22

Yup. A seriously connected and highly regarded investor.

[bertiebingo] 11/2/2023 08:57

Check out the connections for Wiilliam E James (aka Tony) ... Jefferson River, Mount Sinai, Blackstone, Costco.

[mr roper] 11/2/2023 08:39

No point looking back at what they should’ve done. It’s all about the next 12mths. Make or break. Get some revenue momentum and it could go big time

[mr roper] 10/2/2023 21:29

Jefferson Capital taking 8% stake.

[toffeeman] 10/2/2023 14:35

No Wan you are wrong - they should have raised 12 months ago!!

[wan] 10/2/2023 11:56

The recent raise looks well timed, especially if (as expected?) the confluence of events/news continues to build and 'deliver' during the early quarters of 2023. Time will tell!

[red171] 08/2/2023 12:07

Idomeneo

Perhaps it was hopium bs chosing to raise just $20m.

It seems nothing like enough based on bf $31 cash from Q1, Q2 revenue $1 less burn of $(12) [on admin (8) & R&D (4)] = loss $(11) in Q2. So $20 cf into this quarter +$20 raised & loss of $(11)= net inflow $9 unless revenue changes so starting Q4 with $29 buring at $(11) p Qtr - or a run way just over 6 mths.


It does seem like they pulled out their best news to support this raise & they are counting on another one should there be a significant announcement (like on FDA.

Otherwise, wouldn't Mills & other IIs would not benefit more by taking RENX off the market to fund the obvious shortfall in runway?

Perhaps they believe a "milestone heavy short term" as McCulloch expected 30 Nov is the most likely outcome rather than it looks from outside as just continuation of "the apparent industrial scale of lying that the board appear to have indulged" as you put it a while ago.

[volsung] 08/2/2023 09:23

Investors always shafted by small biotechs

[idomeneo] 08/2/2023 09:05

They had a whole year to do a massive one at >800p. They didn't because they believed their own hopium bs.

[tradertrev] 08/2/2023 08:49

Better than doing it at 50p