Renalytix Share Discussion Threads

[mr roper] 31/12/2020 21:13

Yup +10% finish tonight. I’m wondering if we may be getting fda approval in early jan.

[busterdog2] 31/12/2020 18:48

Doing well over the pond again..... so far

[nw99] 31/12/2020 08:01

RENX will be a 2021 star performer

[wan] 31/12/2020 07:47

But not according to the market cap (the market cannot be that wrong!), but time will tell. Good luck though.

[wan] 31/12/2020 07:32

I have no issue with PYC, but possibly the difference can be explained by Renalytix representing a real game-changing technology that's near to the point of delivery, with near term revenues slated at over a $100m that will rise exponentially thereafter. And likely the same type of reason why Bio-Techne acquired Exosome Diagnostics for $250 million, plus up to $325 million in potential milestone payments. I note that Exosome's PROSTATE INTELLISCORE™ (EPI) TEST was also granted FDA Breakthrough Device Designation.

[the stigologist] 31/12/2020 06:07

That doesn't explain relative valuation discrepancy

PYC Mkt Cap £8m vs Cancer therapy market p.a. $200bn

RENX Mkt Cap £300m vs Kidney disease market p.a. $100bn

PYC looks about 80x undervalued !

Would make sense for RENX shareholders to de-risk into PYC imo

[wan] 31/12/2020 05:45

There are many reasons for Renalytix Valuation, such as the track record, experience, and connections of the management team, which includes a deep relationship with Mount Sinai (a significant shareholder and launch partner) which encompasses the Icahn School of Medicine at Mount Sinai and eight hospital campuses in the New York metropolitan area. Importantly, each year kidney disease kills more people than breast and prostate cancer.

Not to mention that the FDA has granted Breakthrough Device designation to KidneyIntelX™ 'effectively' demonstrating that both of the following criteria are met:

1. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions
2, The device also meets at least one of the following:

1. Represents Breakthrough Technology
2. No Approved or Cleared Alternatives Exist
3. Offers Significant Advantages over Existing Approved or Cleared Alternative
4. Device Availability is in the Best Interest of Patients

FDA grants Breakthrough Device designation to KidneyIntelX™
MAY 2, 2019

Provides priority regulatory review of AI-enabled diagnostic for fast-progressing kidney disease

Renalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announces that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX™. This is the first such designation for an AI-enabled diagnostic for kidney disease publicly announced by any company.

KidneyIntelXTM is designed to diagnose and improve clinical management of patients with Type II diabetes with fast-progressing kidney disease, in an effort to curtail the estimated $114 billion annual cost1 of chronic and end-stage kidney disease to the United States healthcare system. The diagnostic will use machine learning algorithms to assess the combination of predictive blood-based biomarkers, including sTNFR1, sTNFR2 and KIM1, in combination with electronic health record information, to identify progressive kidney disease. KidneyIntelXTM is being developed in close collaboration with the Mount Sinai Health System.

The FDA’s Breakthrough Devices Program is a voluntary programme for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the programme is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorisation, consistent with the Agency’s mission to protect and promote public health.

Sally Bowden, Chief Operating Officer of RenalytixAI, said: “This designation is a significant advancement towards our goal of bringing to market a solution that can greatly improve the identification and treatment of patients with chronic kidney disease. We look forward to continuing to work closely with the FDA through this process, including on our data development plan, our clinical validation and our subsequent submission for regulatory clearance.”

Erik Lium, PhD, Executive Vice President of Mount Sinai Innovation Partners, said: “We’re pleased RenalytixAI has received Breakthrough Designation for KidneyIntelX, providing the opportunity to work hand-in-hand with the FDA towards the goal of FDA submission. Renal disease represents an increasing healthcare crisis globally, and early detection and intervention is essential in changing the course of this disease.”

A copy of the FDA’s guidelines on the Breakthrough Devices Program can be found at GuidanceDocuments.

Notes:

[1] United States Renal Data System – hxxps://www.usrds.org/adrhighlights.aspx.

The person responsible for arranging the release of this announcement on behalf of the Company is James McCullough, CEO.


The collaboration with a pharmaceutical and biopharmaceutical giant, AstraZeneca, to improve outcomes for patients with chronic disease (not just CKD) is another example, with the results from the program anticipated in early 2021 -

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.


Both of the above are just two aspects amongst many that are advanced, including a successful spinout of Verici with a retained shareholding, formation of Kantaro and many other advanced developments and partnerships, with Renalytix engaging with multiple healthcare institutions and national payors regarding additional partnership opportunities.

Amongst the many developments, either of the above FDA approval or AstraZeneca collaboration could have a material and positive effect on the share price.

With the AstraZeneca collaboration further demonstrating that Renalytix technology offering is an artificial intelligence-enabled in vitro diagnostic 'platform' capable of addressing other diseases, it will be interesting to see where else this powerful platform might be deployed. Renalytix Chief Executive Officer Mr. James McCullough, was previously CEO at Exosome Diagnostics, a cancer diagnostics firm that was acquired by Bio-Techne Corporation in 2018.

[74tom] 30/12/2020 22:31

The rise in US genomics & precision medicine valuations has been incredible of late. RENX is simply under the radar, once it gets noticed I think it’ll double very quickly. FDA approval, detail on first revenues and any more colour on Kantaro revenues are all potential catalysts.

FY2023 revenue forecasts (year commencing Jun 22) are $108m with PBT of $26.5m which gives an idea of scale up potential. If they hit those forecasts then this will be a multi billion dollar business. $80m of cash on their balance sheet should help with execution!

[the stigologist] 30/12/2020 21:52

Still not heard any rational explanation why one should pay an Infinite variable for zero revenue RENX vs PYC on just EV/Sales of 6x

[the stigologist] 30/12/2020 21:51

If you can't accept other points of view or look at valuation/business comparators you can't have much faith in your investment here.

[mr roper] 30/12/2020 21:37

Yup. Noticed a few US investors tipping Renx for 2021

[donmac101] 30/12/2020 21:27

Renx up nearly 10pc tonight so chance of arbitrage in the morning .Stig your are a right pri..

[the stigologist] 30/12/2020 12:25

PYC on the move today

RENX Mkt Cap £300m Revenues £0m
PYC Mkt Cap £7m Revenues £1m

[the stigologist] 28/12/2020 19:29

PYC Physiomics

Share Price : 6p
Shares o/s : 97m
Mkt Cap : £6m
Cash : £1m
EV : £5m

Great RNS which of course won't be appreciated by the AIM herd because it does require some thinking to read between the lines

1. UK Govt funding to partner with NHS to develope an AI/ML precision dosing tool for ONE form of Cancer (Prostate) with ONE drug (docetaxel)

2. This is a demonstrator/validation project. Once you've developed the algorithms for One Cancer and One drug you can do it for many cancers and many drugs

3. Physiomics allude to ongoing discussions with an 'Established Player' in the Personalised Medicine field (previously revealed it is a US Company). This would facilitate gaining FDA regulatory approval and targeting huge US commercial opportunity



Chart setting up perfectly for a big sustained breakout of this Falling Wedge pattern

An EV of £5m is ridiculous for a UK cancer AI/ML company which has UK Govt/NHS backing and could commercialise this technology in the US

IF this works across many cancers and many drugs and becomes an across the board Cancer Decision Support System for clinicians the potential value in the $100bn+ p.a. Cancer therapy market is mindblowing

[the stigologist] 28/12/2020 19:29

One of the great things about PYC (the RENX of Cancer AI) is that it looks like they won't require FDA approvals as their US partner DoseMeRx / Tabula Rasa operates under a carve out from FDA Regulation under the 21st Century CURES Act.

Makes PYC a very compelling opportunity at only £6m EV vs RENX at £300m

[toffeeman] 23/12/2020 08:51

Anyone got any idea why RENX is so frequently in Auction on IG s-betting platform?

[wan] 23/12/2020 08:09

74tom...Nothing I can do. Best to ignore or use the filter. I believe readers soon work out who the less than scrupulous posters are and subsequently don't even bother to read their posts.

[nw99] 22/12/2020 19:48

Yes he is well known a sad poster

[toffeeman] 22/12/2020 19:44

>> 74tom -> filter - it's easy

[the stigologist] 18/12/2020 09:53

Snippets from Hybridan Research Note on PYC from earlier in the week

[the stigologist] 17/12/2020 19:18

Incredible potential to utilise Big Data/AI/ML to improve scheduling, sequencing, combinations, dosing of cancer treatment regimens in this $200 Billion p.a. market !

Physiomics have spent 20 years building up their Virtual Tumour Model to understand from the ground up how cancer therapeutics work and crucially how they work in combinations

The UK Government/NHS/NIHR funding and trials have been crucial validation AS WELL as giving us crucial access to data in the NHS data 'goldmine'

Now with support of a BIG US Partner we have the potential to commercialise our modelling algorithms in the biggest Healthcare market in the World

That is why you get $5bn start-ups in the field of Cancer AI or Personalised Oncology such as Tempus Labs...