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Highly likely to be a massive winner once launched. We had an update Monday:
https://www.lse.co.uk/rns/AGL/parsortix-her2-assay-showcased-at-aacr-2024-4k393y7ivsvtwno.html
Don't forget Bioview invested £1.2 million of their own cash to develop this which would leverage BOTH Companies FDA accreditation which means the machines are allowed to be used in the USA. The ONLY one ????????????
Immunotherapy targeting a cancers HER2 status is all over the news of late.
Two very recent examples involving Astrazeneca:-
https://www.lse.co.uk/rns/AZN/fda-accepts-dato-dxd-bla-for-breast-cancer-6gb18korpqpp8bb.html
https://www.lse.co.uk/rns/AZN/enhertu-approved-in-us-for-her2-solid-tumours-d992ucbs0xpl3ik.html
All IMHO.
Highly likely to be a massive winner once launched. We had an update just last Monday:
https://www.lse.co.uk/rns/AGL/parsortix-her2-assay-showcased-at-aacr-2024-4k393y7ivsvtwno.html
Don't forget Bioview invested £1.2 million of their own cash to develop this which would leverage BOTH Companies FDA accreditation which maens the machines are allowed to be used in the USA................
All IMHO.
So we lost £21m in 2023 but have made savings that are expected to save £3m. That would give a loss of £18m, but we expect to tripe revenue (recognised) to £6.6m. Ignoring the fact it’s recognised not received that gives a loss of £11.4m from a starting cash point of £15m.
So we better hope the next trading update / results don’t downgrade revenue or the runway will begin to look very short. They’ve also said they expect to break even end of 2025. If we assume (guess) costs stay static at £18m, then we’d need to again treble the revenue going forward.
We need to get a commercial move on.
Any news on the £6m anticipated additional revenues needed to extend the cash run way to Q2 2025 bearing in mind monthly cash burn of over £1.4m, thought not, won't hold my breath here!
Expect more fudging and number games from Newland at the next results and trading sorry meant non trading update or is it funding update, never can tell with Newland!
Streamlining of the Services business outlined below is anticipated to result in c. £0.5 million of non-cash impairments and c. £0.7 million of one-off cash costs in 2023 resulting in an operating loss for the year of c. £21 million, which remains in line with consensus despite the additional charges. The streamlining is expected to deliver cost savings of c. £3 million per annum in 2024 resulting in the extension of the cash runway into Q2 2025.
Streamlining of the Services business outlined below is anticipated to result in c. £0.5 million of non-cash impairments and c. £0.7 million of one-off cash costs in 2023 resulting in an operating loss for the year of c. £21 million, which remains in line with consensus despite the additional charges. The streamlining is expected to deliver cost savings of c. £3 million per annum in 2024 resulting in the extension of the cash runway into Q2 2025.
"Angle Plc Parsortix market. Parsortix machine is FDA appproved for Breast cancer as we know "
And here in lies the dilemma Parsortix is only FDA approved for testing 4% of cancers that is it is only approved for testing breast cancer..
The issue for clinical labs is that Newland is saying its down to them to get FDA accreditation to test for the remaining 96% of cancers.
Well here's the dilemma why should clinical labs take on the suppliers burden and time and cost seeking approval and run the risk of it being rejected....
Equally buying Parsortix risks that clinical labs inadvertently use it to test for non breast cancers and end up heavily find by the FDA or worse still in multi million dollar suits bought by patients whose cancer was misdiagnosed and hence drug treatment.
Meanwhile cash is no doubt down to just £6m to £7m with no sign of that infamous £6m revenues spouted by Newland back in January...finger wagging in the air...this brings funding back firmly into the spot light as cash dwindles from the £22m raised from last years placement on top of the £130m of investors money burnt so far!
Thanks EC.
Bad day for EC share price red ramp fest over!
Bantham
Newland was trying to cover his back.
Imagine a situation a lab buys the Parsortix machine which is only FDA approved for beast cancer testing and a lab clinical technician inadvertently uses the machine to test and send cancer results out to doctor and patients to which Parsortix is not approved to be used to test and diagnose drug treatments....this leads to the risk of misdiagnosis, wrong drugs issued, or the very least a breach of US stringent health regulations leading to multi million dollar fines or at worst multi billion door law suits and associated bad press....ergo no material Parsortix sales to date!
Nice!
Bantham.
So that says - full approval in the US for Breast cancer. No restrictions. Good.
And it says use for all other cancers restricted to drug trials.
Is that correct?
----------------------------------------------------
I believe that is correct. Just the Breast cancer side alone could swamp Angle Plc.
Basically the potential size of the market is quite incredible.
miavoce and TwoGood2Die were arguing over additional potential market from other services labs.
miavoce posted this:-
"Wrong TGTD. CLIA labs do not need FDA approval to use parsortix for testing any cancer types. As long as the labs have validated the tests that they are offering then there is nothing stopping them from offering the test. This is why Angle are developing the Ovarian and Prostate tests (clearly there would be no point them doing this if lack of FDA approval would prevent the tests being carried out by labs).".
I think other Pharma Services Co's who have the CLIA accreditation can offer tests on circulating tumour cells that ***happened to have been obtained*** using the Parsortix machine ***"as long as the labs have validated the tests that they are offering"*** as miavoce said. So I believe there is additional market here too.
All IMHO.
Ok thanks EC.
So that says - full approval in the US for Breast cancer. No restrictions. Good.
And it says use for all other cancers restricted to drug trials.
Is that correct?
Isn’t that what TG2D has been saying or am i missing something?
Therefore is can be used anywhere in the USA to catch Circulating Tumour Cells (CTC's) from people who have metastasized Breast Cancer. Also as American FDA approval is the "gold standard" most other countries will approve it's use too. These CTC's can then be tested to find out for example the cancers current HER2 status, before (if necessary) , during and after treatment. As we know a cancers HER2 status can change over time. The point here is that some modern drugs can target cancers that are HER2 positive (they lock on and deliver poison to the cell). So a tissue biopsy from the original surgically removed lump might be HER2 positive. Then the person may well be given a treatment that targets HER2 cancer cells. All well and good. If however the cancer changes to HER2 negative during treatment then the drug that targets HER2 won't lock on and so the drug won't work. If the change to HER2 negative is known then the treatment can of course be changed. The breast cancer market alone is enormous.
Then there is the massive World wide drug trials market. Parsortix can be used in this scenario for any cancer, not just Breast. In the following video it says Eisai Inc. (top 100 Co. in Japan) have 80 active cancer trials with 60,000 participants. That is just one Japanese Company.............. See 14 mins 45 secs in to this video:-
https://www.youtube.com/watch?v=cnQ6M05BiBY
https://www.youtube.com/watch?v=ZqaWMUx7GhE
All IMHO.
Thanks EC. Could you give us a time during the presentation that he gives a precise answer to the question some of us are struggling with please?
Bantham.
Have a look for your answers here:-
https://www.youtube.com/watch?v=cnQ6M05BiBY
When are they due?
TG2D - now you mention it i remember that. Word soup. Absolutely he was vague. I wonder why.
Miavoce - the question is what specific statements can you source direct from Angle that supports your view? I think you might struggle.
I absolutely don’t know the answer to this question of what precisely Parsortix can be used for ATM - but given the history of this company that certainly raises a question or two.
The time says 09:38:16. Could be earlier today or another day.
No way to tell if was buy or sell.
Would have more than to date. I strongly suspect Mr Newland want's "top dollar" for any deal. This is based on the Parsortix machine being probably the best way to catch a circulating cancer cell for assay tests etc. Also as I understand it 99% of the captured cells are alive and intact, you could hardly get a better sample to test. Also Angle are a relatively small Company so could easily get overwhelmed with orders (perish the thought!). One of the good things about the Bioview contract is obviously both Bioview and Angle want to find a big partner so both sales teams will be busy and Mr Newland will be closely working with the directors of Bioview on any deal.
You only have to look at the last few Astrazeneca annoucements to see the industry desperately needs a way to find our if a cancer is HER2 positive, HER2 low, or HER2 negative before, during and after treatment. At the moment after the initial biopsy it's anyone's guess whether a cancer will remain HER2 positive during treatment. If not, as I understand it, the treatment simply won't work and no-one would know for weeks/months.
All IMHO.
Newland’s “hype & hope” strategy is wearing thin.
Bantham
At January's Investor Meet Newland was playing with words deliberately being vague..what he said is that outside of breast cancer testing, my understanding, labs could use Parsortix to test for other cancers so long as they sort accreditation from the FDA, otherwise Parsortix could only be used for research purposes only. Hence how many lab are going to spend considerable time and cost to gain accreditation for a suppliers machine, answer few if any!
It was a truelly ridiculous statement made by Newland deliberately designed to pull the wool over investors eyes!
This explains why no commercial deals of note to date and highlights how Newland deliberately misleads and misguides investors.
We definitely need some substantive news around commercial progress. Without that then the concerns might not be around the fundraise, but the lack of being able to get one away. I’d imagine the market will want some concrete evidence of commercial progress, details of which are worryingly vague in my opinion. All feels a race against time.
Hi Miavoce
Commercially - i agree. Shareholders do not need to understand in order for Newland to close some deals.
But it’s a point of basic communication. Why not make it totally clear to your shareholders? I mean if it is as you think, allowing this confusion is just id1otic when you would think you need a strong share price for an equity issue in due course.
And the fact that Newland hasn’t closed any significant deals ( yes i do know about the $250k Eisai ) raises questions doesn’t it ?
Hi Bantham
I expect that CLIA labs are not confused and know exactly what they can and can't do. This is all that matters (not the confusion cased by disinformation spread by ill intentioned posters).
The fact that this confusion exits is symptomatic of the failures of communication of this company.
It should be crystal clear from Angle’s communications exactly what can and cannot be done today and what that means commercially. It should be very simple to spell this out.
I admit to being confused on this point.
It’s very basic and very important.