Renalytix Share Discussion Threads

[wan] 06/8/2020 08:29

As previously stated, and given their sterling work to date, I would not be surprised to see Renalytix increase their 'initial' equity interest in Kantaro Bioscience.

[mr roper] 05/8/2020 19:31

Shhezussss! Just looked at Nasdaq. Tremendous. As neil young would say.....long may you run....

[nimbo1] 05/8/2020 19:02

Sleepy mm’s will probably open it at 6.20 over here 😜

[mad foetus] 05/8/2020 18:56

18 now, quite exciting

[74tom] 05/8/2020 18:51

NASDAQ at $17.23...starting to get a move on ;)

[74tom] 05/8/2020 15:02

A few days where 5-10m ADS get traded would certainly shake things up in a good way, could easily happen when you look at the volume of shares traded in the likes of Co-Diagnostics etc.

[nimbo1] 05/8/2020 14:39

I am looking forward to when Cramer talks about the biotechne test which he will following approval. August could be very volatile as fast money comes in (and out) and in again on nasdaq...

[mr roper] 05/8/2020 14:37

$16.71 Stateside. New high.

[74tom] 05/8/2020 13:05

Yes, a few PI’s catching onto the potential here. However I’d estimate that 99.5% of AIM / NASDAQ investors have no idea about RENX, nevermind Kantaro!

[mr roper] 05/8/2020 12:18

Good volume going through today. Could be an interesting afternoon Stateside

[toffeeman] 05/8/2020 10:08

My humble apologies - I should have looked harder, but I will say that Wan is the archetypal benefit of this (and other good) boards, and I am the beneficiary.

[mr roper] 05/8/2020 09:44

Now that’s what I call upside!

[nimbo1] 05/8/2020 09:34

From a Biotechne broker note in US - Biotechne will pay a 50% royalty to Mount Sinai (Kantaro).

'We view this opportunity as having upside in the scale of hundreds of millions, although largely binary'.

[74tom] 05/8/2020 09:33

Cheers, first one I found was the Motley Fool version which was locked. Share price starting to move up now, but volume is still tiny vs what has regularly been flowing through the mainstream Covid testing plays. The utopia here is that the Kantaro test generates significant revenues which can be fed into fast tracking the scale up & internationalisation of KidneyIntelX.

[wan] 05/8/2020 08:27

The excerpts and the full earnings call transcript is available here -

[74tom] 05/8/2020 08:13

Thanks for finding a way to copy and paste Wan! I tried last night but the link seemed to be protected. Really insightful commentary, as well as being scientifically exciting too. Toffeeman needs to do more research, a $10b market cap wouldn't make comments like that if it was going to be 'just one of many'

[mr roper] 05/8/2020 07:47

Exciting times for sure.

[wan] 05/8/2020 07:06

Catherine Schulte

Okay. That’s helpful. And with everything you have going on the Diagnostics side and also in vaccine and therapeutic development, is it possible to quantify what kind of COVID related tailwinds you saw in the quarter and how you expect those to trend going forward?

Chuck Kummeth

Yes. Well, we had 5% this last quarter, right? And that’s going to improve modestly with the current products like Ella and our RNAscope continues to see some traction. We’re selling reagents, we’re even selling antibodies to other test manufacturers, antibodies that we’re not using in our test, of course. So we’re a full-service build supplier to everybody, right? That’s what we do. I think the big upset, of course, is the serology traction. If we get the EUA, these aren’t going to be small orders. If we get this, there’ll be all the large orders and we’re talking with a lot of large institutions.

I will make a comment now to – I mean, the commercial channel and as I mentioned before, it’s one thing to be able to make five to 10 million tests a week. It’s another to get in the engine of doing five to 10 million blood draws a week, and that’s the mission here. So, we’ve got to be working with governments, with large reference labs, the vaccine makers, the hospital management systems out there that are really managing all these labs and working all these blood draws for all these automated testing that goes on every day in the hospitals and clinics around the world. So that’s where we’re really working on now have been for a couple of months already, we are definitely beyond term sheets with some and there is a lot of interest as you can imagine. So, but that’s what’s going to drive the speed of traction and the level of traction, not only this quarter but come Q2 and beyond.

[wan] 05/8/2020 06:57

From the Q&A -

Puneet Souda

Yes. Thanks. I appreciate the details there. And my next question is serology. I think this is a question that we’ve been getting from investors as well. What is your expectation here for contribution from serology in fiscal year 2021? And I’m asking that because COVID serology market has lagged significantly behind the PCR market given that PCRs more has essentially more diagnostic capabilities. Obviously, serology is only giving you a snapshot in time. So – and some of the peer companies have also lowered their expectations in serology significantly going into the next quarter. So I’m wondering what are you baking in for serology? And what gives you confidence that you can grow sort of above the market here in serology?

Chuck Kummeth

Sure. Well, I want to give you some comments here, and they’re really meant for everybody, not just you. So I’m not going to cover the same ground here, and then questions later and that we will get this out kind of to all of you at once just to be really careful. We’ve invested a lot in our test. We have submitted a one hell of a dossier to the FDA, let me tell you. And it is an incredible data package. We have gone far and beyond, really what the FDA requires for something like this. As you know, it’s a two-step. When we decided to go fully quantitative a couple of months ago and take a step back and take some extra time, the FDA, first of all, was starting to get clogged up with an awful lot of request.

Two, being we’re talking about asking for a fully quantitative EUA and nobody else has done that that. And they really, really asked for an awful lot of extra stuff, extra data, extra testing. We have complete sensitivity data done. We did crossed reactivity test against 14 major diseases. We have stats on all this that are phenomenal. We know of nothing out there that compares, but we don’t maybe know everything that’s coming out either. So we’re only talking what’s out there now. We do also know and the FDA, regrettably so, knows that they’ve issued a lot of preliminary EUAs that they probably regret and a lot of these initial qualitative tests have become a tarnish to the whole serology potential. And we have to overcome that. But we’re very sure and we’re very clear on the fact there’s a need for a quantitative serology test that really can identify the level of immunity in a patient.

And this is going to be important. More and more important as these vaccines come in the market, and patients who want to know, are they having a response or not. And so we see a surveillance side of this, it’s going to only grow, and it’s not going away in a year. So will it match the – are you sick now testing environment to PCR, maybe not. But it’s going to be a very large market, and we’re not a very big company, and we’re going to have the best test, at least for a while. So we’re very confident that we’re going to be treated very fairly by the FDA, and we’ll be out there before this quarter end, hopefully. But there’s no guarantee. This is the FDA, and there are hundreds of tests out there, trying to get in, in all different forms. We know of nothing else out there that can match us.

We had incredible partners with Kantaro and then Mount Sinai. They are managing most of the bureaucracy here being – we’re not that experienced at it. And we’ve got great consultants on the staff through Kantaro as well who’ve really taken control of our dossier and our package, our data, everything. Our team here at Bio-Techne has worked around the clock for months now and has really fulfilled their mission, we feel. And we’re ready to go. And we’re not kidding, we’re ready to go at millions per month, if not millions per week. So – but you’re right. Right now, it’s kind of a 10% kind of market demand compared to PCR, but we think it’ll improve. And it will improve with the test getting better with vaccines coming on the market and the economy is opening up, and people want to go back to work, and knowing they’re safe to go back to work. So we’re ready. We’ve been waiting for this, and we’re ready.

[wan] 05/8/2020 06:56

From the Bio-Techne fourth quarter earnings call -

Before I turn the call over to Jim for a financial review, I want to provide an update on what could be our biggest COVID-19-related initiative to date, our co-branded R&D system, Mount Sinai COVID serology assay test. During the quarter, we announced a collaboration with Kantaro Biosciences, a Mount Sinai led joint venture to manufacture and commercialize the serology assay based on Mount Sinai’s test. This was a tremendous effort by both the Bio-Techne and Mount Sinai teams, convincing the typical 18-month ELISA kit development timeframe to just six weeks.

This two-step serology test is a truly differentiated offering going beyond the qualitative information provided by other COVID serology assays in the market, with the second step providing a tighter or measurement of the antibodies present to neutralize the virus. The second step completely eliminates false positives with Mount Sinai’s assay having a 100% Positive Predictive Value or PPV and 99.6% Negative Predictive Value or NPV.

To date, diagnostic activity is focused on PCR or antigen-based test to detect active COVID-19 infections. We believe serology test volumes will increase as a second wave of testing emerges focusing on the surveillance activities necessary to reopen an economy and to help better manage vaccination program for once available.

Yesterday, Kantaro Biosciences submitted a request to the FDA for an Emergency Use Authorization or EUA for quantitative use of our serological assay. We anticipate the EUA process to be complete in mid- to late-August. Kantaro and Bio-Techne have joined forces to develop marketing materials, a branding and go-to-market strategy for the assay, highlighting the unique quantitative information provided as well as the best-in-class performance of the assay. We are ready to launch this assay upon receipt of the EUA, and have the capacity to produce millions of tests per month as needed.

He went on to say -

We are in the cusp of launching the first commercial quantitative IgG COVID-19 serology assay, which has potential to answer many of the important questions necessary to reopen our economies further and push the best vaccines forward.

[wan] 05/8/2020 06:23

As of the 3rd August the FDA has authorised 198 coronavirus diagnostic tests under EUAs, of which only 35 are antibody tests, none of those are quantitative!

The Kantaro test is currently unique, it's the world's first commercial fully quantitative test, most are qualitative and only two are semi-quantitative, meaning that they do not display a precise measurement, but 'estimate' the number of a patient’s antibodies produced. These two tests, from the giant Siemens, were only authorised on the 31st July.

Furthermore, an important aspect is that the Kantaro test (unlike the Siemens test for example) is performed without the need for proprietary equipment. So, in theory the limitations to use are few, meaning the test can be used widely and globally!

[toffeeman] 04/8/2020 22:43

There are quite a few IGg tests out there ours will be just one of many.

[fardistanthills] 04/8/2020 22:39

Verici now showing in my ii ISA account - 1 for each RENX I hold. Valued at £0.00 but I confess I've totally lost track of how / when some value will attach to them!

[2theduke] 04/8/2020 22:07

Thanks for the comments on the letter re spin off shares all.
I’ll update when I get mine.