Renalytix Share Discussion Threads

[tomboyb] 31/10/2022 10:56

Good start today -

[tomboyb] 31/10/2022 09:22

Get this to £1+ -

[mr roper] 31/10/2022 09:20

Agree, wan. I can see fda approval and the replacement mcit draft rule converging in Q1. That can only bring further positive attention

[wan] 31/10/2022 08:28

Mr Roper...In my view and as previously indicated, Renalytix is reaching a tipping point on a number of fronts, and FDA De Novo, which is now more a case of a very focused 'when and not if', will be one of a number of accelerants.

I also think that the combination of accelerating testing volumes, increasing insurance coverage, increasingly supportive real-world clinical evidence, and the more imminent FDA authorisation, will at the very least focus the minds of the potential strategic partners (diagnostics, dialysis and pharma), which may trigger the anticipated strategic partnering events.

And if you care to speculate somewhat, such partnering could actually fit well with Renalytix current cost/overhead reductions i.e. potentially, the strategic partners could integrate KidneyIntelX within existing programs and be integrated into their existing/in-place global sales forces.

[mr roper] 31/10/2022 07:58

Looks like the stars may align on that, wan.

Reading the results I'm a little more optimistic than I was.

Focus on extending cash to h1 2024 is a big positive.

Testing growth is the big one for me. What's the path to 5000 a quarter.

[wan] 31/10/2022 07:37

From todays Results -

FDA De Novo marketing authorization for KidneyIntelX

We continue to work closely and constructively with the FDA on our De Novo Breakthrough Device authorization submission. Notably, we have provided additional comprehensive data which further confirms the performance of KidneyIntelX in risk discrimination for patients with diabetic kidney disease. We now believe we are approaching the completion of the De Novo regulatory process and while there is no guarantee of success until FDA has made its final determination, we are optimistic based on both the quality of analytic and clinical evidence provided and the high level of engagement we have had with the FDA. Our current expectations are for a decision to be made in calendar Q1 2023 but there can be no guarantee on this timescale.
(ENDS)

Aligning well with my own thoughts (FDA De Novo Q1 2023) and the contents of my post 1997 above. KidneyIntelX, a possible FDA exemplar for a breakthrough device and an exemplar in reducing disparities in health and health care.

[mr roper] 31/10/2022 07:10

Interesting results.
Tests hit a record for the quarter but they need to turbo charge that growth.
Fda nearing completion.

Will be keen to hear more on the call later

[mr roper] 28/10/2022 11:26

Nice research, wan. Fingers crossed

[videologic] 27/10/2022 09:06

Yes, likewise took a few more.

[tomboyb] 27/10/2022 08:59

took a few -

[mr roper] 26/10/2022 20:33

$rnlx +17%

[idomeneo] 26/10/2022 14:25

Randy Baron trying to promote something he promoted at 850p. Down 93%ytd. Year ago sales est E22 $32m e23 $75m. today?:$4m then $13.5m. This is a "must have" medical product in the US market which keeps disappointing. Randy says they have enough cash to get until 2024, but they lost $47m last year. I just don't see it. The only way this could ramp quick enough to not needed repeated funding is if an Abbott sized company bought it. But why would they when Ren has to fund the tests that are actually taken?

[wan] 26/10/2022 11:13

Heads-up provided by Walbrook PR -

Today, Kate’s guest is Randy Baron, portfolio manager at Pinnacle Associates. The three stocks Randy discusses today have small market capitalizations. In a market pullback, small stocks get hit first but are also the ones that do best in a new rally.

What value Randy sees in a small U.K.-based healthcare stock called Renalytix that addresses the issue of chronic disease -The biggest companies in the dialysis space are DaVita (DVA) and Fresenius (FMS), but Renalytix offers another approach to treating kidney disease before the late stages -

Renalytix discussion starts at 12m 24sec -

[donald pond] 26/10/2022 11:12

Randy Baron (sic) likes it https://the-marketbeat.zencast.website/episodes/3-small-caps-with-big-upsideAll coverage is positive, no listened yet

[faz] 26/10/2022 10:52

Donald, I think they are naive in many ways, but there's no financial control in this company thats for sure. Whether the product itself has any merit is also not proven, obviously by the lack of take-up - they recruited enough salespeople! And where have the plnas to sell this into Europe gone? Whether the US medical profession are lemmings, waiting for a certain number to take it up and then all follow, we'll wait and see, but with the share price well over 90% down from when I and many others sold there'll be plenty like me wanting to see meaningful traction and commercially viable earnings before buying back in.

[donald pond] 26/10/2022 10:38

It looks like the board took their eyes off overheads in the period before revenues ramp up, but if that process is now beginning in earnest (big if) then given the margins you would think they would do anything to avoid a ruinous dilution at this stage. I recall 2/3 years ago the suggestion that revenues could jump from minimal to very significant in no time: CEO BS or prescient? Jury is out

[wan] 26/10/2022 10:24

I do understand your stance, and indeed that healthy discussions are good and welcome.

[mr roper] 26/10/2022 10:09

Fine wan. We disagree on a few things that's good. I don't think the bod have earned the benefit of the doubt over the last 12 mths so I'll continue to be doubtful and focus on possible downside risk until proved otherwise.

As always until the company disclose some tangible information we'll continue to speculate.

[wan] 26/10/2022 09:45

Well, in my view another reason for having the 'potential' to raise 'already' in place, demonstrates that you have alternatives to any terms that are deemed too constraining and contained within potential strategic partnership contracts.

So, given Renalytix has already stated that they are in strategic discussion with a range of potential partners, including pharma and diagnostic players, in my book, it appeared good housekeeping in more ways than just the one that some were first interpreting.

With regard to your comment "If someone at medicare has to check the supporting medical evidence for each test before payment then I can't see it being particularly scalable". I completely disagree!

Two things, the announcement that Medicare Administrative Contractor (MAC) National Government Services (NGS) has initiated payment of claims for KidneyIntelX testing, could also drive private payor on-boarding. In that the rationale for Medicare coverage having to meet appropriate medical necessity criteria, is also in-place within most insurance health plans. 2nd, the evidence can be supplied by a doctor or other provider, which is very likely to be what's happening with the KidneyIntelX tests -

National Association Of Insurance Commissioners

Understanding Health Care Bills
What Is Medical Necessity?

How is “medical necessity” determined?
A doctor’s attestation that a service is medically necessary is an important
consideration. Your doctor or other provider may be asked to provide a
“Letter of Medical Necessity” to your health plan as part of a “certification”
or “utilization review” process. This process allows the health plan to
review requested medical services to determine whether there is coverage
for the requested service. This can be done before, during, or after the
treatment.


So, if tests are accompanied by a letter of Medical Necessity, one assumes it does not exactly hold up the process, or delay the payment (as Renalytix has indeed indicated). Therefore, I don't accept your analysis that the process can only cope with low volumes.

[mr roper] 26/10/2022 09:15

Put it a different way. They will need funding soon. How they get it.. dilution or partnership is up for debate. The main question is does a partner see enough to step in...perhaps yesterday's news is enough to get a heads of terms in place. Hopefully more news on Monday.

[wan] 26/10/2022 08:52

The raise and dilution you refer to is not imminent nor a given, but it is very important to have in place. Amongst others, a strategic partnership has the potential to negate the need for a fund raise, and as we know, Renalytix are in advanced discussions with a number of potential strategic partners.