Renalytix Share Discussion Threads

[wan] 26/10/2022 08:26

Above post edited.

[wan] 26/10/2022 08:19

Mr Roper...I appreciate that you and others are (justifiably) downbeat on Renalytix, however, the potential for both a steady re-rating, are very real when you consider the (unfortunate) vast size of the market in the US (not to mention the potential beyond 'initial' DKD), and indeed the possibility for a large positive inflection point, if you consider the attractiveness and potential from one or more strategic partnerships due to a very large initial market, but an even larger US market overall when you factor in markets beyond DKD and indeed beyond just the US.

In post 1958 (13th Oct 2022) I highlighted what I thought was a positive development (unconnected to the recent news), I note that the Investec Note above also aligns with that train-of-thought.

[mr roper] 26/10/2022 07:58

Interesting that the medicare test applies to tests processed at the NY lab irrespective of where the test was carried out. Step in the right direction but may be too little to late

[wan] 26/10/2022 05:49

Shares finished up over 36% on relatively high volume in the US at $1.45, equivalent to approximately 65p

Again courtesy of Ramyris over on Discord in the US, analyst note from BTIG -

“Strong first step in the right direction.” -

And again from Ramyris, Investec - Current target price £2.97 under review post yesterdays announcement -

[74tom] 25/10/2022 21:06

Glad to see a bounce, intrigued to see what the results bring next Monday. They will dictate whether it’s a dead cat or the start of something more substantial.

[mr roper] 25/10/2022 17:40

+20% Stateside. First step in the recovery or a dead cat?

[mr roper] 25/10/2022 17:08

Because they sold before the news. They're not privy to inside information.

Looking at the share price decimation over the last 12 years I think most funds apart from Harwood will be OM the sidelines waiting to see if the company can deliver anything.

[cambridgedon] 25/10/2022 15:31

Well, if it was, they obviously don't think the upcoming results are worth waiting for!
Why would it not be someone increasing their stake in light of improving newsflow?
Which is more likely?
CD

[mr roper] 25/10/2022 15:11

Yes very. Suspect it was a large holder, possibly GGH selling out.

[cambridgedon] 25/10/2022 14:32

Just noticed that last week there were two days of exceptionally large volume. Looks like the 19th was the highest volume ever. Significant??
CD

[cambridgedon] 25/10/2022 14:16

Thanks Wan. I agree it's positive. Let's hope the results show some significant progress,
CD

[wan] 25/10/2022 14:06

Brief Stifle note courtesy of Ramyris over on Discord in the US -

[wan] 25/10/2022 12:47

CD...2022 Results are next Monday 31st October. I would assume that we might get some indication of the degree of ramp in the outlook and during the conference call.

[wan] 25/10/2022 12:44

Hashertu...Well, it's not exactly what the RNS states, but bearing in mind that NGS reviews each claim to determine its medical necessity payment timelines are within Medicare's 30-day targeted timeframe for payment, then depending on that review process (and it's clear that claims are meeting the medical necessity criteria)the invoices raised/processed would presumably get paid the following month.

The main thrust is that KidneyIntelX has certain coverage via the Federal Medicare Administrative Contractor at $950 per test, and formal coverage is now in play too. And this is on top of a backdrop of increasing private insurance coverage and new medical systems coming on-line, along with a 10-year government contract covering payment for patient testing in the Veterans Health Administration Medical system.

You will note that additional plans have indeed been added -

We keep adding
new insurance plans.
Look below for your specific insurance plan. If you don’t see it now, check back with us. New plans are added regularly.

If you have any questions, call our Patient Support Team at 844.870.8870.

[cambridgedon] 25/10/2022 12:31

This is one of the most opaque statements I have read! Payments appear to have been made?? No mention of how much or how many claims are in the pipeline, plus, it doesn't make it clear what the benefit is of LCD.(faster payment?)
One would have thought that a company whose market cap has fallen by 97% would be keen to highlight any positive news about revenue!
CD

[hashertu] 25/10/2022 11:48

Wan. My interpretation of the RNS is that RENX have received the first payment(s) (cash) for a process that started in July. Do you agree?

[wan] 25/10/2022 08:26

Welcome news today of a solid step in the right direction in terms of a likely increase in the revenue being generated compared to previous quarters (my interpretation), and submission of a formal request to establish Local Coverage Determination for KidneyIntelX.

And given we are in Renalytix fiscal 23 (commenced 1st July), and the full effects of cash burn-rate reduction are expected to be realised in the fiscal second and third quarters, combined with an acceleration in testing volumes, appears to bode well that Renalytix is turning the corner and reaching a tipping point in terms of system adoption, test volumes and revenues, and proving to the market they have a 'real and viable' sustainable business.

[mr roper] 17/10/2022 10:56

Won't be holding our breath waiting for fda or medicare though. No sign of the BoD buying stock in the market at these bargain prices tells you pretty much all you need to know.

[wan] 17/10/2022 08:00

Today's announcement of presentations at the American Society of Nephrology (ASN) Kidney Week (November 3-6, 2022) appears to sit well what the FDA and Medicare, including the forthcoming expedited Medicare coverage pathway, is looking for e.g. Multi-year, Real-world, rigorous evidence.

[faz] 14/10/2022 22:07

one of the bluffs about this company and MOunt Sinai's proposition was the opremise of this company ie the only thing they've got, was that Artificial Intelligence, the combination of mathamatical formulae (algorithms) could produce information that fed into other algorithms (some of them sekf-generating) to produce meaningful data to inform patient diagnosis. if successful that would save lives vs. existing data, doctor experience and intuition. If successful it would re-invent diagnostic practise across the world. THe share is 50p. Go figure.

[mr roper] 14/10/2022 08:41

Fda - no update
National Medicare coverage - no update
Partnerships - no update

If I was to hazard a guess, there’ll be zero tangible progress on all 3 this year.

Last chance saloon now. The new strategy of focussing on regional sales growth may get them somewhere but they need to get to 1-2000 tests a month very quickly e.g by March imho to show any value in the business, otherwise it’s a cheap piece of tech for any acquirer that already has a sales infrastructure.

[wan] 13/10/2022 05:30

Positive development -

Medicare Plans Draft Rule to Accelerate Medical Device Coverage
Oct. 12, 2022

New medical devices could start undergoing review for Medicare coverage before receiving FDA marketing authorization under a proposed rule the Biden administration plans to release in the coming months.

Officials from the Centers for Medicare & Medicaid Services announced Wednesday that the proposal would establish a pathway that medical device manufacturers can enter on a voluntary basis to start getting their products reviewed earlier. The action is part of a series of efforts by the CMS and the Food and Drug Administration to better coordinate their product reviews so that patients can get quicker access to novel treatments and emerging medical technologies.

“The CMS remains committed to establishing an expedited Medicare coverage pathway that achieves timely and predictable coverage of medical devices while at the same time ensuring that coverage is based on scientifically sound clinical evidence,” CMS Chief Medical Officer Lee Fleisher and Chief Operating Officer Jonathan Blum wrote in a piece published in JAMA Internal Medicine.

Fleisher and Blum wrote that the forthcoming CMS proposed rule “would strike a balance between promoting access to emerging medical technologies and maintaining the protections and rigorous evidence standards that are essential to the welfare of Medicare beneficiaries.”

Full story Bloomberg law -

October 12, 2022
A Vision of Medicare Coverage for New and Emerging Technologies—A Consistent Process to Foster Innovation and Promote Value

[mikemine1] 07/10/2022 16:36

The FDA approval is not key to sales. RENX has plenty of contracts with medical insurance companies and bodies that provide cover for their members and employees. The pathway to commercialisation is clear and taken. Watch a few interviews and this will become clear. Let's wait and see what progress on sales is reported in the next RNS.

[yasx] 07/10/2022 14:54

Nothing matters except sales and FDA is key to that.

You can have all the clinical studies and data but if you have no pathway to commercialisation, from a shareholders point of view it is of nil significance.