Renalytix Share Discussion Threads

[wan] 30/7/2022 09:38

Interestingly I note Millenium have reduced their short position on three occasions of late, 25th July, 26th July and 27th July, to the lowest level since March 2022. Perhaps indicative of the bottom, and perhaps mindful of the indicated news flow potential that could result in positive share price catalysts now being somewhat concentrated into the remaining months of 2022.

The following recent study is interesting and indicative of the need for technology such as KidneyIntelX -

Role of Finerenone in the Treatment of Diabetic Kidney Disease: Patient Selection and Clinical Perspectives

Authors Shaikh A, Ray J , Campbell KN

Received 31 March 2022

Accepted for publication 11 July 2022

Published 29 July 2022 Volume 2022:18 Pages 753—760



Future Directions
The advancements in therapeutic drug development for DKD are happening at a faster pace than ever before. Several on-going clinical trials may offer additional options for management of DKD. The FLOW trial is the first long-term kidney outcome trial, studying the efficacy of the GLP-1 RA, semaglutide, on kidney outcomes.56 This study includes patients with T2DM and eGFR 50 to 75 mL/min/1.73m2 and UACR 300–5000 mg/g or eGFR 25 to <50 mL/min/1.73m2 and UACR 100–5000 mg/g. All patients must be on maximally tolerated dose of RAAS blockers.

The EMPA-KIDNEY study is a Phase 3 primary kidney outcome trial testing the efficacy of empagliflozin in patients with diabetic and non-diabetic kidney disease.57 This study, designed to shed more light on the use of SGLT2i in over 6600 diabetic and non-diabetic CKD patients, includes participants with DKD with eGFR 20 to <45 mL/min/1.73m2 or DKD & Non-DKD with eGFR 45 to <90 mL/min/1.73m2 and UACR ≥200 mg/g. In contrast to the previous SGLT2i kidney outcome trials, EMPA-KIDNEY includes patients with eGFR as low as 20 mL/min/1.73m2 and those with normal, or mildly increased albuminuria.58 This trial was stopped early due to clear positive efficacy based on interim analysis, with pending published results expected to broaden our understanding of the role of SGLT2i across the full spectrum of eGFR and albuminuria.

Conclusion
The FIDELIO-DKD and FIGARO-DKD trials have demonstrated the renal and cardiovascular benefits of finerenone on background RAAS blockade therapy with the associated risk of hyperkalemia significant, but lower than historically observed with steroidal MRAs. The potential benefits of finerenone and SGLT2i combination therapy in DKD are unknown. Several ongoing trials will assist in identifying additional therapeutic agents for DKD. The rapid emergence of new therapeutic options for DKD is exciting, and now more than ever, clinicians must tailor therapy to the individual needs of their patients.

Disclosure
The authors have no relevant conflicts to declare.



Readers will note the particular reference to hyperkalemia. To my mind highlighting the importance of the partnership with AstraZeneca where the first stage of that agreement was to assess the impact of AI-enabled in vitro diagnostic solutions to optimize utilization of therapeutics in CKD under current standard of care protocols. Based on study outcomes, a multi-center, randomized controlled trial will be initiated to evaluate uptake and adherence to new potassium-binding agents in patients with CKD and hyperkalemia. But in any regard, one can see that KidneyIntelX could be useful to more than AstraZeneca.

Hence my comment recently that one could see a combination of AstraZeneca and Another partnering with Renalytix's technology offering, which may provide the ultimate combination in terms of having a material impact on kidney care, and indeed patient outcomes.

Staying with technology, in an interview yesterday AstraZenca, in reply to a M&A question and what areas/gaps are you looking to fill, highlighted the importance of technology. Saying that "we are mostly looking for technology or products that can compliment the products we have" -

M&A/Technology question and answer starts at 4m.55s -

[74tom] 29/7/2022 19:15

Not according to all of the chat on LSE a few weeks back, apparently they dumped the whole stake...

[rhatton] 29/7/2022 09:46

Does Amati Global still hold this?

[mr roper] 18/7/2022 18:28

Re partnerships..let's not forget we already have partnerships with AZ and DaVita...of which we've heard absolutely nothing.

Unless the partnerships are focused on ramping up near term revenue generation they're probably best avoided. Renx have 95 employees and enough going on without overstretching further imho

[wan] 18/7/2022 08:58

The above article provides much food for thought in terms of, on the one hand AstraZeneca appears to hold a strong market-leading position regarding SGLT2's, which clearly they will want to at least maintain, but other players are aiming for a much larger slice of a growing and global market. That's a large amount of healthy competition looking to gain an edge!

We know that Renalytix plans to pursue further collaborations with pharmaceutical companies and make ‘Pharmaceutical Services Revenue’ a core part of the business going forward with the goal of improving guideline-based standard-of-care for optimal utilization of existing and novel therapeutics using the KidneyIntelX testing platform and proprietary care management software.

And recently Renalytix stated that "We are now in advanced discussions with larger potential strategic partners in the pharmaceutical and diagnostic distribution categories", with the diagnostic element being new, which I am more than intrigued by!

Not that I am suggesting everything is revolving around AstraZeneca (far from it), but recall from my post 1837 -

Almac Diagnostic Services collaborates with AstraZeneca to Develop and Commercialise Companion Diagnostics (CDx)
June 23, 2022

CDx programmes initiated under master collaboration agreement

Almac Diagnostic Services, a member of the Almac Group, today announced it has signed a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialise multiple companion diagnostic (CDx) products. Almac will work to support AstraZeneca in its drive to bring new therapies to patients globally in disease areas of high unmet need.

Under the terms of the agreement, Almac will develop and validate specific CDx assays for patient selection in various AstraZeneca clinical trials across a range of therapeutic areas including kidney disease, non-alcoholic steatohepatitis, and respiratory disease. Almac will seek regulatory approval for individual CDx assays in agreed jurisdictions in tandem with linked AstraZeneca therapeutics. To date, a number of programmes have already been initiated under this model.

Professor Paul Harkin, President & Managing Director, Almac Diagnostic Services, commented: “We are delighted to have signed this CDx master collaboration agreement, which represents a further strategic alignment with AstraZeneca, and enhancement of an already strong relationship. We are looking forward to working collaboratively together to develop and commercialise these companion diagnostic tests to help identify the right patient populations that will benefit from future AstraZeneca targeted therapies.â€

Full release -

My main thrust here is that how can individual pharma's market share be increased or further protected, not just now but going forwards, which could also include unique biomarkers that enhance and augment the treatment. And with KidneyIntelX designed to be scalable and capable of incorporating additional discoveries and developments in novel biomarkers, expanded clinical indications and integrated digital technologies, the attraction should be strong, including that beyond CKD alone.

In short, it would appear there is real potential for agreements, including covering multiple indications beyond CKD, with multiple strategic partners, and/or indeed strategic partnership combinations e.g. pharma/diagnostic. And a combined partnership would appear to create the widest moat for the parties concerned.

[wan] 15/7/2022 07:56

keep in mind that Renalytix is focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care and that
KidneyIntelX is the only test with the ability to identify the 1 in 5 diabetic kidney disease patients who will experience rapid kidney disease progression – vs those who won’t – to help guide an actionable, targeted plan for what’s next.

With the above in mind, the following interview provides food for thought -

AstraZeneca is looking to grow its blockbuster Farxiga brand outside of its original diabetes label and more deeply into chronic kidney disease.

AstraZeneca ramps up Farxiga push in new kidney disease label as it uncovers the challenges of this 'silent disease'
By Karl Greenberg Jul 14, 2022

Like the business end of an iceberg, the majority of CKD (chronic kidney disease) patients go undiagnosed until damage is done.

That’s according to a new study funded by AstraZeneca, which markets the blockbuster metabolic and heart disease drug Farxiga for CKD. The company’s take on the study: Prompt testing, diagnosis and treatment will help a patient (and healthcare professionals) steer clear of morbidity and massive healthcare costs for this silent disease.

“There is considerable public health potential in diagnosing CKD using widely available low-cost testing, as well as providing treatments to those currently diagnosed,” said Helen Yeh, vice president, CVRM therapy area biopharmaceuticals medical at AZ, in an interview.

He added that another important takeaway from the study is the need to focus on measured CKD, not merely diagnosed disease (since only a third of patients are in the latter category).

Full article -

Put another way, an increase in the diagnosis of CKD, will result in an increase in the 'measurement' and management of CKD, with improve patient outcomes and significantly reduced healthcare related costs.

[mr roper] 08/7/2022 16:22

The bod have 6 mths to transform the outlook imho.
If was being picky James was talking about partnerships being announced in H1 this year, Tom McLain was telling us how full Medicare coverage was expected mid year...stuff is slipping regularly.

I see the Oryx fund still think they transform the kidney diagnostic sector but it’ll require patience.

I’d add that patience is more readily applied when they see high levels of competence.

I’d like to see the CFO and CEO buying in the open market especially as the CFOs best financial decision was selling 350,000 this time last year.

[wan] 04/7/2022 11:24

The benefits are clear, but you need to consider how the 'evidence' was arrived at.

As one example, it might be informative to consider Renalytix partnership with AstraZeneca -

RenalytixAI to Collaborate with AstraZeneca to Improve Outcomes for Patients with Chronic Disease

Parties to adopt multi-phase approach to develop precision medicine strategies to optimize treatment of cardiovascular, renal and metabolic disease

NEW YORK, August 21, 2020 - Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), today announced a collaboration with AstraZeneca (LSE/STO/NYSE: AZN) to develop and launch precision medicine strategies for cardiovascular, renal and metabolic diseases.

The first stage in the collaboration will use KidneyIntelX, an artificial intelligence-enabled in vitro diagnostic platform, to examine further improving outcomes for patients with chronic kidney disease (CKD) and its complications, in coordination with the Mount Sinai Health System. The goal of the first stage is to help improve guideline-based standard-of-care for optimal utilization of existing and novel therapeutics using the KidneyIntelX testing platform and proprietary care management software.

An estimated 700 million patients worldwide have CKD,1 which is also associated with an increased risk of metabolic and hematologic complications, such as hyperkalemia (elevated levels of potassium in the blood) and anemia.2,3

The first stage will assess the impact of AI-enabled in vitro diagnostic solutions to optimize utilization of therapeutics in CKD under current standard of care protocols. Based on study outcomes, a multi-center, randomized controlled trial will be initiated to evaluate uptake and adherence to new potassium-binding agents in patients with CKD and hyperkalemia. The studies will be conducted in coordination with the Mount Sinai Health System, where KidneyIntelX testing and care management software are currently being deployed for commercial clinical use.


The following recent update/RNS, in 'coordination with Mount Sinai clinical use' (cue the above?) might be instructive, which provided positive real world evidence -

1,112 Patient Study Demonstrates Clinical Utility and Care Benefits of KidneyIntelXTM Risk Stratification in Stage 1 to 3 Diabetic Kidney Disease Patients

Late-breaking data presented at American Diabetes Association Scientific Sessions® demonstrates increased adherence to care guidelines for physicians using KidneyIntelX risk assessment to improve outcomes, alleviate patient suffering, and reduce significant financial burden associated with rapidly progressing chronic kidney disease

NEW YORK, NY and SALT LAKE CITY, UT June 10, 2022 - Deployment of Renalytix's (NASDAQ: RNLX) (LSE: RENX) KidneyIntelXTM bioprognosticTM testing in 1,112 adult diabetic kidney disease (DKD) patients at Mount Sinai Health System demonstrated utility in driving guideline appropriate use of therapies, including SGLT-2 inhibitors and RAAS inhibitor use, and timely consultation to specialists in high-risk patients. The Mount Sinai clinical utility data was presented as a late-breaking ePoster session on June 5th at the American Diabetes Association 82nd Scientific Sessions® in New Orleans. In the study, more than half of KidneyIntelX prognostic tests were ordered by primary care physicians, followed by endocrinologists. Application of guideline-based care, including therapeutics and appropriate specialist consultation, increased in proportion to reported risk of rapid progressive decline in kidney function (e.g., low, intermediate, or high risk).

"Before KidneyIntelX, we did not have a way to effectively predict which patients with early stage DKD are at higher risk for progressive loss of kidney function and kidney failure," said Joji Tokita, M.D., Clinical Director, Division of Nephrology, and Associate Professor, Medicine (Nephrology), Icahn School of Medicine at Mount Sinai. "Nearly 95 percent of patients with chronic kidney disease are in stages 1 through 3, but its progression is often asymptomatic until it progresses to end stages and the damage is often irreversible. End-stage kidney disease results not only in poor quality of life for patients, but significant and costly care that can include cardiovascular complications, increased hospitalizations, dialysis and transplant. I'm encouraged to see the real-world application of KidneyIntelX by my primary care colleagues, where we can follow guideline-based care to reduce patient risk early and change the trajectory of disease progression and costs."


Put another way, that appears to fit well with the Renalytix/AstraZeneca phased approach (in coordination with Mount Sinai), where it was indicated that if the first stage is successful in improving health outcomes, additional randomized studies will be launched to assess the adoption of new potassium-binding drugs.

[yasx] 04/7/2022 10:09

DP,

But are the benefits clear? I mean, if we really look at it, would the Pharma sector really want a better diagnostic tool which might render many of thier drugs moribund if there is earlier detection and better outcomes? Let us not kid ourselves, the FDA and Pharma are not about promoting cures or better health by early intervention due to better diagnosis.

[wan] 04/7/2022 10:04

DP...Yes, I do understand, and thus they need the capacity to 'accommodate' such big deals

[donald pond] 04/7/2022 09:40

Wan,The issue here isn't what could happen, it's what has happened to date. The high margins and apparently obvious benefits to all parties from identifying kidney disease early are clear. What isn't clear is whether the company can balance its costs and its income. They need to find a big deal quickly.

[wan] 04/7/2022 09:24

Whilst we know that Renalytix is planning for such partnerships, it's good to look at and consider the backdrop in this regard, and bearing in mind that Renalytix is also targeting the potential to significantly expand the utility of the KidneyIntelX platform, particularly in understanding how to efficiently enroll and characterize appropriate participants in new drug validation trials and indeed drug-target discovery.

Food for thought -

As M&A costs rise, new Accenture report offers alternative strategies
Rising deal premiums and shrinking profit margins are threatening the sustainability of the traditional approach to mergers and acquisitions, according to a report by Accenture. The firm expects growth-minded companies will turn to other pathways.
By JOEL BERG

Jul 1, 2022

Accenture expects companies will continue to pursue deals under the architecture pathway. But that strategy may change. Instead of focusing on early-stage assets, buyers may look to gain access to platform technologies.

The firm also sees promise in the ecosystem pathway, which covers acquisitions of know-how and capabilities to speed up innovation or reach customers in new ways. Examples cited by Accenture include analytics, artificial intelligence and new devices.

Between 2010 and 2021, ecosystem deals represented 16% of the total number but only 1% of the deal value, Accenture said. However, the firm said, an ecosystem deal was one of the largest deals announced in the runup to the J.P. Morgan Healthcare Conference in January 2022: the collaboration between Sanofi and Exscientia, an AI-powered drug discovery company.

Ecosystem deals also provide the biggest short-term bounce to stock prices, according to the analysis by Accenture.

Full article -

The shorts, who have been right thus far, had better be ready to run for cover if such partnerships come to fruition!

[wan] 04/7/2022 08:50

The 'fact' that Renalytix is also planning additional funding through collaborations, strategic alliances, and licensing arrangements, makes my point regarding strategic partners and healthcare partners particularly relevant in my view, whether other factors are also at play remains to be seen and as I said it covers a multitude of options.

But having a large facility in place/ready, means that Renalytix can consider many options, which includes deals where the partner 'also' wants an equity stake and interest in the business (including the expansion of the platform, where the attraction and relevance will increase). Time will tell!

[yasx] 03/7/2022 16:33

Wan,

Having the option of raising does not mean they will be able to raise at a reasonable level - they look like they are in a precarious situation right now and unless FDA approval lands very soon (if it does they should immediately raise into any positive sentiment relating to that) or sales partners elsewhere come on board in numbers very quickly, this looks like it is heading for the biotech graveyard to join many speculative plays that ended up there.

[wan] 03/7/2022 06:34

It would appear there are a multitude of potential reasons for the $300m shelf, and one possibility might be if a strategic partner, of which there could be more than one, wanted a material stake in Renalytix.

That particular aspect aside, demonstrating that you can raise or have access to significant cash (if accepted by SEC) as and when required, is probably quite important when you are negotiating deals/partnerships, in terms of demonstrating solid solvency alongside the capacity and capability to deliver.

Put another way, it doesn't mean they will utilise the shelf, but they could!

[yasx] 01/7/2022 13:18

On the FDA, all they suggested was it was moving forward but that they were, on balance, very negative on the entire process. Does not seem like this is on the radar anytime soon.

[yasx] 01/7/2022 12:52

Interestingly, the Co. on the call continually referred to modulating spend - but, when that chap Randy Baron put them on the spot as to how much they expected to reduce the burn to they just waffled and refused to offer any guidance but referred to this being offset by (non existent) strategic partnerships.

That tells you what you need to know.

[yasx] 01/7/2022 12:14

The conference call simply highlighted all that is wrong with this Co. - they talk of the need for cutting costs as being at the core of what they are trying to do, yet the results demonstrate the exact opposite - unjustifiably high cost base with no focus on capital discipline.

As for waiting on potential partnerships before providing forecasts, well, that says it all.

Robotic delivery, no commercial focus, delusional detachment from reality.

Talking of the scale of the market when you are unable to even capture a small fraction of it is just waffle to excite holders.

Operating expenses are off the scale and attributed in part to due to higher headcount/compensation to support growth (but then you actually realise there is little to no growth!).

[yasx] 01/7/2022 10:23

It is hard to see how this will be around this time next year, at least not in the current form - almost certain to go bust.

[yasx] 01/7/2022 10:19

STX and 4d both recently failed to attract interest when seeking to raise funds by way of a placing - the biotech sector is one that is being shunned right now.

Renx is no different - they neither have the time nor options to turn this around - they may get a deeply discounted placing away at some point but that will merely extend the salaries of the Board for a while before the plug is pulled. Even securing FDA interest is now a little too late to salvage this wreck.

When this was capitaliserd at over $1BLN, they knew they had no FDA approval nor any idea as to when that would be received, coupled with no revenues. Surely, basic financial planning ought to have made them realise that tat that point they should have raised as much as they could to see them through until milestones such as FDA approval were granted.

To leave it until this stage to try and raise more funds, at a time when sentiment is onthe floor is absurd.

This is all you need to consider and then focus on the magnitude of the task ahead - is it even realistic to pretend they are not facing an insurmountable problem?

"During the three months ended March 31, 2022, the Company recognized $0.8 million of revenue (Q3 FY21: $0.6 million). Cost of revenue for the three months ended March 31, 2022 was $0.7 million (Q3 FY21: $0.2 million).".

There is no tunnel, let alone light at the end of it.

[melody9999] 30/6/2022 23:13

Terrible results - and no indication from management that they intend to cut and control costs wherever possible (as opposed to merely report them).

Value destruction

Digger 1875. My holding has been decimated, so I need to stick with it!
No you don't!! You could get out right now.