focusIR May 2024 Investor Webinar: Blue Whale, Kavango, Taseko Mines & CQS Natural Resources. Catch up with the webinar here.
On the 11th January American presentation AN said that the labs would open in UK within 1/2 months. He said the US lab would open March/April.
We then had the uk presentation on the 22nd January where AN said the ealry Pharma contract services would be announced shortly.
These updates and hopefully PD-L1 assay will be updated to market imminently. PD-L1 in itself is a $b market.
I think the market respects that this is a class II de novo application for a diagnostic tool which poses no risk to health unlike therapeutics. As such it’s risk profile is significantly lower and that applications in this category have historically had a very high 90%+ success rate for In-vitro applications.
With the peer reviewed papers demonstrating Parsortix as superior to the only exciting Fda approved device Cellsearch, in addition to ctDNA. We have significant evidence over and above the breast cancer and ovarian trials.
Throw into the mix we have had the same FDA case manager who is now reviewing the De Novo application for the last 5 years and we also submitted a Q submission. Like many others, I would say approval is a formality.
Application made on the 25 September - 150 days up on the 22 February, with the company providing a sensible cushion of expectation going into Q2.
Watch this space
MAJOR EUROPEAN CONSORTIUM
Just waiting for the Major Pharma Contract which is due shortly and is outlined in the YouTube video last night. Expect another RNS
Question is, was today’s presentation released on YouTube (confidential @ bottom of presentation), after the markets closed part of an update tomorrow and further comments on the earlier shared article, or a bit of unprompted promo ??
https://youtu.be/p8_o-8QZP_I
Closed at 82p UT
https://www.nature.com/articles/s41598-021-82068-9.pdf
Perhaps one of the reasons why the company mentioned a large Pharma services contact soon and an earlier webinar implied the first contract would be PD-L1
Not to just take the multi billion dollar valuation gap into consideration but the 5 key strategic objectives that are to come to fruition over the next 6 months, many of which target multi billion dollar emerging revenue streams.
We know news drives share prices and as per the presentations, partnership discussions, parsortix upgrade, ovarian cancer study completion and conversion to lab based test ($b market), proof of concept, labs, fda approval and a highly differentiated solution that provides competitive advantages over its peers.
A massive PLATFORM to growth. All for less than £180m. A trajectory like ITM has been on from its lower levels is not inconceivable.
Take out 85p and it will very quickly exceed 100p imo.
So far Iv heard that on various forums including social media. In the 50/60 and now 70’s and in all probability the same will be said when this is over 100p.
In all honesty, every pull back has been bought into and at some point we will see some more consolidation, but when the market cap is still only £167m, you only needs to look to it’s peers and the multi multi billion pound opportunity ahead.
Imagine what a partnering agreement would do to the share price!
For what its worth, and obvious to some, a significant market cap of 3/4/500m would assist a Nasdaq listing which would take this to a new level altogether. All of which is coming and more!
Isn’t truly reflecting the strength here (yet).
Would not be surprised to see breakout
Hooray, but no different to the other 29 approvals in the in vitro category who also found themselves in exactly the same position.
Persimmon - I think de novo has to be remembered for what it is:
The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
‘No legally marketed predicative device’, making the Q submission inherently valuable in this process to further manage the outcome and avoid withdrawal in an attempt to seek additional information such as clinical frials
We are class II of III which further derisks the proposition and therefore time imo.
Everyone is entitled to an opinion both positive and negative as I am trying/actively to identify the risks.
I found this information of great benefit to understand the de novo process better than I otherwise would of.
While it’s case specific I think it’s true to say that in vitro products would have a higher urgency within the approval process and in line with Trump and now Biden’s policy to reduce the red tape and speed up cancer related processes if anything it goes to show the Q2 approval, even with a delay is more likely than not.
Thanks Dibs.
Imo, a rising share price in anticipation is highly probable and as we can see is currently taking place. We have seen the likes of STX and POLX rise in anticipation of approvals and an important consideration here is the shear size of the $130b liquid biopsy market opportunity. In my opinion a share price leading up to approval of 100/150P is highly probable and for the company who are obviously in pursuit of a Nasdaq listing will do everything it can to re-rate the market cap in anticipation of this listing so as to minimize future dilution.
Very exciting times.
My final point on the subject in response to likelihood of FDA approval and will the share price go up if they don’t get approval, REALLY, Common!?!
Nothing is ever guaranteed but AGL have taken various steps over the last several years to increase the probability of success. In addition to many peer reviewed papers and leading cancer centers throughout the world using Parsortix to study future improvements in cancer diagnostics/treatments. AGL have also carried out a Q submission so as to address a majority of the forthcoming questions up front so as to minimize any significant delay.
Following submission of the FDA application on the 25th September and confirmation that it was accepted on the 20th October. Subject to the De novo 150 day targeted response that will be haunted subject to further questions, AGL have done all they can to derisk the process and in my opinion stand a very high chance of approval, thus the reason for my investment as a shareholder.
Not only will AGL see a significant increase in its revenue through ongoing cancer trials using it as an alternative or in addition to cellsearch, it is extremely telling that Madeline Repollet joined ANGLE in 2020 as the Head of Clinical Laboratories. This is extremely telling as she co-developed cellsearch, make of that what you will.
GL.
RD - just to put into perspective the potential upside for the likes of Abbott and it’s HER2 diagnostic tool. With a current cost of $350/400, to use AGL’s tool as a companion they expect to achieve $3.5k to $4k per patient, a ten times uplift to the current target revenue profile of Abbott for this test. This will require a further study and will form part of an upcoming deal between both parties which is also likely to command some sort of upfront payment.
With the likes of Abbott seeing a threat to some of its future revenue lines from the likes of Guardant health, Abbott and many of its competitors have no choice but to act to retain its current commanding position. This is probably why Abbott asked for exclusivity, but that will come at a considerable cost.
Detection of high risk groups and therapy selections represent an $8b annual revenue current focus. Medium term they will access treatment and remission treatment in a $75b annual revenue target segment. We then have the long term target of early screening for cancer worth an additional $50b. As most will know, this will be progressively targeted and will rely on the normal post approval FDA ramp up to significant revenues as a market share.
To put this into perspective Grail is to be bought for $8b and has no revenue and we have many other examples such as Burning rock biotech worth over $3b with Q3 revenue of only $18m.
I have to remind myself of the fact that the likes of PWC foresee a buoyant diagnostic sector ripe for deals and takeovers. We will have many companies looking to replace Covid diagnostics revenue that will start to dwindle over time, with significant cash reserves available to replace it with a hot diagnostic like liquid biopsy.
https://www.pwc.com/us/en/industries/health-industries/library/pharma-life-sciences-quarterly-deals-insights.html
As a companion diagnostic and currently in dialogue with several potential partners, we have a bottleneck of news that will help rerate the share price over time. To consider a valuation anywhere near close to its multi billion dollar peers is hard to comprehend, but with a Nasdaq listing in the pipeline, you better start believing.
Many are referring to the broker note of 150p, but as I read the post it infers that this is after FDA approval, when in fact the 150p target is as of now with no further developments expected that would otherwise serve to increase that target further.
- FDA approval
- Partnerships
- Etc
This has an awful long way to run yet and still presents absolute value imo. You can spend an awful long time researching this and the story just seems to get better.
Naturally this increasing share price will attract traders that you can see a mile off, but they will have no impact on the ultimate story and share price projection as I see it.
Lol, my bad ‘nasdaq’
It was telling when he said that AGL was CURRENTLY listed on aim with emphasis on currently, an RNS stating an intention to list on aim is inevitable.
They are also in several discussions with collab partners which was also very telling and for me two of the key highlights of yesterday’s presentation.
also interesting to note that from 16:00 yesterday the views on YouTube have gone from 140 to 390, 60 of which were clocked from midnight to now. It’s definitely gaining US traction Imo
A combination of Jupiter exiting and respective UK based funds not being appropriately positioned/targeted to appropriately value emerging biotech/diagnostic/Pharma companies has presented us with a fantastic opportunity.
Just look at SLN market cap and what happened to a hot sector and pending Nasdaq listing and they are nowhere near FDA approval.