Renalytix Share Discussion Threads

[74tom] 30/6/2022 08:44

That was a nightmarish RNS, no other word for it. In my opinion the CFO needs to be replaced ASAP with someone who can actually manage the companies finances. To raise capital 3 months ago at £2.76 and then decide that no, you actually need to raise more cash via a $50m ATM facility is frankly unbelievable. Accountants are supposed to be prudent and plan for the worst!

Ultimately it comes back to the points discussed here a few months ago; why on earth didn't they raise significant capital last summer when the market cap was >$1b if they were planning to expand overheads to a $40m run rate? It's just ludicrous & threatens to destroy any chance they had of commercialising a potentially brilliant product. I'll be very surprised if this comes back now, I'll keep watching but am out for the foreseeable future.

[mr roper] 30/6/2022 08:17

The only smart financial decision I can see is the CFO selling 350000 last June.

They have probably until end of September, if I'm really generous, December to show significant milestones being hit and a steep growth in revenue.
The jury is out. As I said they can talk the talk and for all the CEOs talk of it not being their first rodeo...it looks to me like they've never seen the animal they're supposed to riding

[nimbo1] 30/6/2022 08:13

this has more chance of going bust than being a winning company at the moment. At a time when capital is very expensive... dilution here will be substantial and its in a death spiral... can it cross the valley of death? Not sure unless they get their act together. Perhaps someone like caredx will buy it. I hope Renx can turn it around and I have no position here but comment because I owned it from £3/4-6/7 and like the company (or used to!)

[mr roper] 30/6/2022 08:09

Not getting any real transparency on their planned growth trajectory. Needs to be a better call than last quarter.

Revenue for q3 and FY is well below par.

They appointed a sales team for VHA last June and we still have no product live with them to sell. Must be a paid holiday for the sales guys.

On the positive side, they're testing with wakeforest now.

They need to give guidance for FY 2023 now.

Looks like another group who can talk the talk so far but not much else

[donald pond] 30/6/2022 08:05

It does seem somewhere between reckless, incompetent and criminal to be increasing staff costs so significantly at a time when revenues are non existent

[faz] 30/6/2022 08:04

You can suggest confidence pays bills too, but it doesn't. Confidence, there next to 'we love our products', is a vacuus business asset Wan as you should know.

[wan] 30/6/2022 08:00

As I suggested recently, Renalytix have reached a tipping point in terms of having confidence for inaugural testing and revenue guidance. In my view, that confidence is an important factor to consider given the weighting to milestone events in the second half of calendar 2022.

[nimbo1] 30/6/2022 07:40

Dreadful progress on the revenue front.

[faz] 30/6/2022 07:26

Only six months of funds left even after the recent fund raise. It wants the right to sell $300m worth of shares when it is valued at a third of that, with what seems like an immediate intention to sell $50m of them. THis company which I htough could be such a pathfinder only knows how to pay its own people, it doesnt seem to have a viable sales model or an accountant able to demand the Board reign in spending. They cite hiring staff as an achievement and bang on about it, yet it is now costing $40m a year; revenue of $2.9m. Can this ever be a profitable company while it is being led by such poor business people.

[mr roper] 29/6/2022 09:36

Double post

[mr roper] 29/6/2022 09:36

From the last quarter report

-- KidneyIntelX now on-line with the Veterans Administration health system (VHA), New York physician led payor program CDPHP, Wake Forest Baptist Health and Atrium Health system

-- Hired, trained, and deployed regional sales managers, sales representatives and medical science liaisons to support KidneyIntelX physician onboarding, education and test ordering

Delivered revenue of 1.3m. I'm looking for $3m plus revenue for this quarter reporting. 300 tests pw at Sinai on its own should cover this without factoring in the others. However my gut tells me they won't be at 300pw at Sinai.

[wan] 29/6/2022 08:21

Staying with: arguably HCP's might need a 'prognostic' tool for that increase in treatment options which can enable them to deliver enhanced and differentiated personal interventions - KidneyIntelX -

Future thinking: developing a holistic approach to cardio, renal and metabolic disease
By Hannah Balfour (European Pharmaceutical Review)
28 June 2022

Dr Clark explained that with the development of empagliflozin, as well as the company’s broader pipeline, Boehringer Ingelheim has taken an interconnected cardio, renal and metabolic disease approach.

The prevalence of comorbidity in these patients has led scientists to believe that cardio, renal and metabolic diseases may exist on a spectrum, with interconnected pathways and contributing factors”

Comorbidity is a well-established concept in the cardiovascular, renal and metabolic disease fields. A 2021 study of chronic kidney disease (CKD) found that 98.2 percent of patients with CKD had comorbidities,11 with a referenced work suggesting diabetes, obesity and hypertension were the most common.12 Furthermore, studies of diabetes patients have established the high prevalence of CVD comorbidities, a study of almost 250,000 diabetes patients found almost a third had established CVD,13 where another much larger literature review found CVD affected 32.2 of type 2 diabetes patients overall and was the cause of death for 10 percent of type 2 diabetes patients.14

The prevalence of comorbidity in these patients has led scientists to believe that cardio, renal and metabolic diseases may exist on a spectrum, with interconnected pathways and contributing factors. This theory has been supported by the clinical results of drugs such as empagliflozin, the SGLT2 inhibitor, across several of these conditions.

Beyond empagliflozin, one of Boehringer Ingelheim’s advanced development programmes taking a holistic cardio, renal and metabolic disease approach is their dual glucagon-like peptide-1 (GLP-1)/glucagon receptor (GCGR) agonist developed in partnership with Zealand Pharma. The drug advanced through to Phase II trials in adults living with obesity and also those with NASH in 2021. This programme has received FDA Fast Track designation.

“From antihypertensives to thrombolytics, anticoagulants and more, globally we have extensive research experience and our study programmes, combined with a lot of translational studies, providing us a depth of insight into cardio-metabolic diseases is informing future areas of research, with a focus on unmet need. These future areas include obesity, non-alcoholic steatohepatitis (NASH) and chronic kidney disease,” he stated.

Dr Clark concluded: “These developments bring together the disciplines that treat patients living with these comorbid diseases, helping to drive a cross-functional patient-centred approach. Being able to address these interrelated conditions via a more holistic approach is an exciting step forward and one that will hopefully make a big difference to the lives of patients living with one or more of these inter-related conditions.”
Full article -

[brummy_git] 28/6/2022 14:08

Christopher Mills of Harwood Capital talks about renalytix here (starts 26;20)

www.linkedin.com/posts/paul-hill-a5994116_vox-markets-fund-manager-interview-with-christopher-activity-6947490289783603200-5DnF?utm_source=linkedin_share&utm_medium=member_desktop_web

hxxps://www.voxmarkets.co.uk/articles/vox-markets-fund-manager-interview-with-christopher-mills-3caf5ae

[wan] 28/6/2022 07:37

Pharma competition to treat chronic kidney disease is set to materially increase -

Lilly and Boehringer's Jardiance poised for challenge to AZ's market leader Farxiga in chronic kidney disease: Spherix
By Natalie MissakianJun 27, 2022

Life science launch analyst Spherix reached that conclusion after analyzing the results of two surveys—one of 104 U.S. nephrologists and another of 330 nephrologists, cardiologists, endocrinologists and primary care doctors.

While Farxiga is currently the SGLT2 inhibitor of choice among nephrologists, Spherix found Jardiance’s early trial stop has made an impression: Nearly 70% of the kidney specialists surveyed in April expect to write more prescriptions for the drug in the next six months in response to the news, with 14% of those expecting a “significant” increase.

Both Jardiance and AZ’s Farxiga were originally approved as diabetes meds but also aspire to treat heart failure and kidney disease, as all three conditions are now thought to be interconnected.

Full article -

Arguably HCP's might need a 'prognostic' tool for that increase in treatment options which can enable them to deliver enhanced and differentiated personal interventions - KidneyIntelX

[mr roper] 27/6/2022 16:37

I'm hoping that now the fundraise is done the bod take the time to get a vit more clarity on their plans to rollout to the various health systems and when we should start to see consistent revenue growth from more than just Mt sinai. We've had a sales team in place for 12mths and I've no idea what on earth they can sell without us being live in those health systems.

Fingers crossed for Thursday. No More fluff please.

[mr roper] 27/6/2022 08:19

As always, time for them to start delivering.

[wan] 26/6/2022 07:51

Hi 74tom...Arguably it's a complex situation/picture with so many important aspects increasingly coming into play.

I think that the 'getting distracted' comment probably sums up the level of interest and opportunities presenting to Renalytix beyond those already announced (eg increasing inbound interest from a number of different pharmaceutical companies large and small), and the need to stay laser focused on the FDA process, US health system expansion and the scaling up of testing. Along with study data with key findings, that include monitoring therapeutic response and impact in clinical decision making/therapy management.

And therefore the possible expansion of the KidneyIntelX platform, including but not limited to, the inclusion of APOL1 genetic testing. Also in this regard, the exclusive option agreement with Joslin Diabetes Center for patent filings on certain additional novel biomarkers in kidney disease for development and deployment in the KidneyIntelX in vitro prognostic platform should not be overlooked, and has further potential for a catalyst in terms driving further pharma interest and a significant widening of the Renalytix moat -

These novel biomarkers have the potential to provide additional clinical utility for understanding early disease progression and risk of kidney failure, therapeutic response, and the mechanistic pathways of kidney disease beyond the inflammatory and tubular injury markers that are currently captured by KidneyIntelX. RenalytixAI plans to begin evaluating these novel biomarkers in expanded clinical validation studies beginning in the second half of 2021.

“These proprietary blood biomarkers have 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. We believe they could also contribute to a better understanding of patient response to approved drug therapies,” said Fergus Fleming, Chief Technology Officer, RenalytixAI. “We look forward to working with Joslin and other research and pharma collaborators to build a platform to advance our understanding of underlying causal pathways of kidney disease, and bring precision medicine solutions to clinical practice.”


Clearly some of the 2022 milestones e.g. FDA approval, pharmaceutical and other strategic partnerships etc, have the potential to provide material inflection points in terms of the share price.

Critically, Renalytix might have reached a tipping point in terms of pharma interest, the increasing amounts of data, testing volumes and importantly the direction of travel (across a numerous aspects), which might mean there is confidence for inaugural testing and revenue guidance, which obviously has the potential to change the dynamics, not to mention analysts coverage (and counter short positions).

[74tom] 25/6/2022 11:59

Hi Wan,

Thanks for your recent posts - you do a great job of trying to join all of the dots!

Your last post combined with the previous one on DaVita / Fresenius summarises why it is an incredibly complex picture at present. Renalytix are in the picture, however it's so difficult to say with any precision exactly where they stand.

Take the opening salvo from their own AZN collaboration PR almost 2 years ago;

"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."

"Results from the program are anticipated in early 2021."

However here we are in mid 2022 and no further news has been released. Same goes for the DaVita partnership which was supposed to launch in 2022. Positive updates on either of them would likely be enough to kick start a share price recovery.

So I ask myself what is holding them back? Is it a case of focusing all of their resources on completing the FDA process & scaling up testing revenues from KidneyIntelx in the VA / Sinai / other health systems whilst putting the other partnerships to one side for the moment?

I note that recently the CEO said something like 'our biggest risk at present is getting distracted', so that suggests this could be the case.

My honest view right now is that RENX is an enigma to 99% of the market. I'm hopeful that the call this week will start to provide some answers but we've been here for some time so I won't hold my breath.

At least the US healthcare sector is showing signs of life at long last & the RNLX share price closed at $4.70 yesterday (equivalent to £1.90)

[wan] 25/6/2022 09:45

Recall that KidneyIntelX is Designed to be scalable. Additional discoveries and developments in novel biomarkers, expanded clinical indications and integrated digital technologies.


Thus, the following provides food for thought -

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.”

Full release -

So, perhaps it's also worth bearing in mind the following -

• Expand Our Product Portfolio
We believe there are significant opportunities to expand our technology platform through incremental version releases of KidneyIntelX as well as through extending the KidneyIntelX platform into new applications into additional populations of CKD patients beyond those with diabetes, including repeat testing to monitor changes in risk and therapeutic response and other CKD subtypes, including patients of African ancestry with the APOL1 high-risk genotype. We also intend to develop solutions for use in other large chronic disease patient populations, like CKD associated cardiovascular disease. KidneyIntelX has been designed within a regulated, manufacturing-quality environment to allow us to take advantage of the dynamic nature of machine learning to improve product performance through a sequence of controlled version releases. We believe that our product development approach, which is based on a quality systems framework following FDA’s Quality System Regulations and the ISO guidelines applicable to medical devices, will enable our KidneyIntelX platform to rapidly generate exponential data growth and new clinical use cases, with a clearer path to achieving the regulated and reimbursed introduction and subsequent product improvements of an artificial intelligence-powered in vitro diagnostic.

• Real World Evidence Program.
Through our growing number of health system partnerships, pharmaceutical collaborations and payor models, we are creating a comprehensive real-world evidence (RWE) and data generation program including the previously announced programs at Mount Sinai, Wake Forest / Atrium Health and Utah Health. The primary objective of demonstrating the clinical and economic impact of KidneyIntelX informed care management in large populations and we expect to expand the scale of this program with extensive publication and dissemination of the results. Additionally, through these Institutional Review Board (IRB)-approved and patient consented studies we will be amassing a vast biorepository of urine, blood and DNA samples (already planned to exceed 10,000 patients) linked to comprehensive longitudinal patient data which will help accelerate the development of diagnostic products and data solutions for kidney disease and related complications and co-morbidities. Importantly, we are actively pursuing opportunities to leverage the KidneyIntelX platform and this unique RWE program focused on chronic condition management at primary care to other indications, most notably, kidney disease associated cardiovascular disease, heart failure and liver disease.

A further significant value creation aspect of our RWE program is the enablement and deployment of our comprehensive digital health and data strategy. This program provides an invaluable access to users and insights that inform the features we are building into our digital technology and data platforms.

[digger18] 17/6/2022 18:19

Renx submitted their FDA De Novo application at roughly the same time as AGl, So hopefully a decision will soon be forthcoming.

[wan] 17/6/2022 07:35

Experts Elevate New Drugs for Diabetic Kidney Disease
Mitchel L. Zoler, PhD

June 16, 2022

US clinicians caring for people with diabetes should take a more aggressive approach to using combined medical treatments proven to slow the otherwise relentless progression of chronic kidney disease (CKD), according to a new joint statement by the American Diabetes Association (ADA) and a major international nephrology organization presented during the American Diabetes Association (ADA) 82nd Scientific Sessions.

The statement elevates treatment with an agent from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class to first-line for people with diabetes and laboratory-based evidence of advancing CKD. It also re-emphasizes the key role of concurrent first-line treatment with a renin-angiotensin system inhibitor (an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker), metformin, and a statin.

The new statement also urges clinicians to rapidly add treatment with the new nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) for further renal protection in the many patients suitable for treatment with this agent, and it recommends the second-line addition of a glucagon-like peptide-1 (GLP-1) receptor agonist as the best add-on for any patient who needs additional glycemic control on top of metformin and an SGLT2 inhibitor.

The consensus joint statement with these updates came from a nine-member writing group assembled by the ADA and the Kidney Disease: Improving Global Outcomes (KDIGO) organization.

"If You Don't Screen, You Won't Find It"
Rossing also stressed the importance of regular screening for the onset of advanced CKD in patients. Patients whose estimated glomerular filtration rate (eGFR) drops below 60 mL/min/1.73m2 as well as those who develop microalbuminuria with a urinary albumin-to-creatinine ratio of at least 30 mg/g (30 mg/mmol) have a stage of CKD that warrants the drug interventions he outlined.

Guidelines from both the ADA and KDIGO were already in place recommending annual screening of patients with diabetes for both these parameters starting at diagnosis of type 2 diabetes or 5 years following initial diagnosis of type 1 diabetes.

"If you don't screen, you won't find it, and you won't be able to treat," Rossing warned. He also highlighted the panel's recommendation to treat these patients with an SGLT2 inhibitor as long as their eGFR is at least 20 mL/min/1.73m2. Treatment can then continue even when their eGFR drops lower.

Starting treatment with finerenone requires that patients have a normal level of serum potassium, he emphasized.

One reason for developing the new ADA and KDIGO statement is that "discrepancies in clinical practice guideline recommendations from various professional organizations add to confusion that impedes understanding of best practices," write Katherine R. Tuttle, MD, and associates in a recent commentary.

The goal of the new statement is to harmonize and promote the shared recommendations of the two organizations, added Tuttle, who is executive director for research at Providence Healthcare in Spokane, Washington, and a KDIGO representative on the statement writing panel.

Full article -

[wan] 17/6/2022 07:25

Following on from my comment in post 1830 that KidneyIntelX might be needed individually for singular drug treatments, or indeed when treatments complement each other -

Drug combinations may help to slow the progression of diabetic kidney disease

Reviewed by Emily Henderson, B.Sc.
Jun 15 2022

A mouse study led by Washington University School of Medicine in St. Louis suggests that combining SGLT2 inhibitors — a newer class of diabetes medications that lowers blood sugar — with older diabetes drugs may help to slow the progression of diabetic kidney disease. Commonly prescribed SGLT2 inhibitors include dapagliflozin (Farxiga), empagliflozin (Jardiance) and canagliflozin (Invokana).

Diabetes is the leading driver of kidney disease, a potentially fatal condition affecting 37 million Americans, many of whom are unaware that their kidneys are ailing. No cure exists, and current treatments for end-stage disease primarily are limited to dialysis and kidney transplant.

In pursuit of improved drug therapies to protect the kidneys of patients with diabetes, a mouse study led by Washington University School of Medicine in St. Louis suggests that combining SGLT2 inhibitors — a newer class of diabetes medications that lowers blood sugar — with older diabetes drugs may help to slow the progression of diabetic kidney disease.

Commonly prescribed SGLT2 inhibitors include dapagliflozin (Farxiga), empagliflozin (Jardiance) and canagliflozin (Invokana). The l

"SGLT2 inhibitors have had remarkably positive effects on kidney disease in diabetes, the best effects that we have seen in decades, yet scientists have not understood specifically how and why these drugs work so well. By studying mice, we found that these drugs may work even better to protect the kidneys when combined with other diabetes drugs, and with this approach, we should be able to achieve better outcomes in patients because the drugs act in a synergistic way on the kidneys, at least at the cellular level."

Benjamin D. Humphreys, MD, PhD, senior author, director, Division of Nephrology, Washington University

Most patients with type 2 diabetes are prescribed only a single drug, but the study's results suggest that combination therapies may be more effective because the different drug classes target different cell types in the kidney.

"We are in a very exciting time for treatments of diabetic kidney disease," he added. "Our study adds to growing evidence that combination therapies offer strong benefits to patients. We think such approaches should be adopted in routine clinical practice."

Full article -

[wan] 12/6/2022 07:41

Investors bet on AI start-ups to turbocharge drug development
Companies have raised hundreds of millions of dollars despite a troubled biotech market
Hannah Kuchler and Clive Cookson in London
JUNE 11 2022

Start-ups promising to use artificial intelligence to transform drug development are raising hundreds of millions of dollars and signing deals with Big Pharma, despite the recent sell-off in biotech stocks.

Owkin, a French company, is partnering with Bristol Myers Squibb to improve how the US drugmaker designs its trials in a deal worth up to $180mn, including milestone payments if the drugs pass regulatory hurdles.

Investors are also tempted by the prospect of partnerships with large pharmaceutical companies, which are recognising they do not have all the skills they need in-house. Bristol Myers Squibb already signed a $1.2bn deal with AI company Exscientia last year, and both Owkin and Exscientia recently signed partnerships with French drugmaker Sanofi.

Venkat Sethuraman, head of global biometrics and data services at Bristol Myers Squibb, said the company was “very bullish” on how AI could help improve the designs of clinical trials and wanted to work with Owkin because of its “complimentary data set”. Owkin uses federated learning, a machine learning technique, to train its algorithm on hospital data, without ever seeing the data itself.

Full story FT.Com -

KidneyIntelX data does not get much coverage/discussion, but clearly it is potentially very valuable. Renalytix also state the following -

KidneyIntelX, has been granted Breakthrough Designation by the U.S. Food and Drug Administration and is designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery.

Expansion of Product Portfolio
We believe there are significant opportunities to expand our technology platform through incremental version releases of KidneyIntelX as well as through extending KidneyIntelX application into additional populations of CKD patients beyond those with diabetes, including patients of African ancestry with the APOL1 high-risk genotype.

We also intend to develop solutions for use in other large chronic disease patient populations, like cardiovascular disease. KidneyIntelX has been designed within a regulated, manufacturing-quality environment to allow us to take advantage of the dynamic nature of machine learning to improve product performance through a sequence of controlled version releases. We believe that our product development approach, which is based on a quality systems framework following FDA’s Quality System Regulations and the ISO guidelines applicable to medical devices, will enable our KidneyIntelX platform to rapidly generate exponential data growth and new clinical use cases, with a clearer path to achieving the regulated and reimbursed introduction and subsequent product improvements of an artificial intelligence-powered in vitro diagnostic.
(END)

One of the other aspects that caught my attention recently was international expansion, which got a particular mention during the recent 42nd Annual William Blair Growth Stock Conference, where James McCullough, CEO, discussed the strategic partnerships that were in late-stage discussions and that such partnerships would help with national and 'international' expansion (which obviously goes hand-in-hand with the above).

Strategic partnerships 20.40 sec in -