Member Info for EmeraldCarrots

Yesterday, so very good news. RNS's about additional contracts expected..........

R&D tax credit:-

https://www.lse.co.uk/rns/GDR/receipt-of-rd-tax-credit-ahmxvgd366h5atq.html

- £500,000.00

Additional grant funding:-

- £200,000.00

https://www.lse.co.uk/rns/GDR/additional-grant-funding-under-devote-programme-2vhxtl0zvqt4mzf.html

=================

+ £700,000.00

Current market cap £9,000,000 approx.

- Financially about 8% gain.

R&D tax credit:-

https://www.lse.co.uk/rns/GDR/receipt-of-rd-tax-credit-ahmxvgd366h5atq.html

- £500,000.00

Additional grant funding:-

- £200,000.00

https://www.lse.co.uk/rns/GDR/additional-grant-funding-under-devote-programme-2vhxtl0zvqt4mzf.html

=================

+ £700,000.00

Current market cap £9,000,000 approx.

R&D tax credit:-

https://www.lse.co.uk/rns/GDR/receipt-of-rd-tax-credit-ahmxvgd366h5atq.html

Additional grant funding:-

https://www.lse.co.uk/rns/GDR/additional-grant-funding-under-devote-programme-2vhxtl0zvqt4mzf.html

=================

Current market cap £9,000,000 approx.

From final results 29/11/2024.

"· Entered into a Clinical Trial Agreement with a leading multi-state physician organisation for clinical research studies of the Genedrive® MT-RNR1 Product Range in the US as part of planned FDA submission."

===============

When did this start? I wonder how much real world evidence we have to date for the FDA submission?

Holy smoke! Are Illumina ALREADY plannning to use their lung cancer "dual analysis" assay panel with the NHS in Wales!?

This panel was developed for use with Angle's parsortix machine as the machine can catch live circulating tumour cells (CTC's), perfect for DNA analysis!!!!!!!!!!!!!!! This was only recently, however they know it works so not wasting any time starting to use it?!!

https://pharmaphorum.com/news/nhs-wales-partners-illumina-genomics-drive

https://www.lse.co.uk/rns/AGL/analysis-of-ctc-dna-and-ctdna-using-illumina-assay-mqynkijrkyza9ga.html

All IMHO.

The assay panel illumina now sell for the dual analysis of CtDna and CTC's, developed recently with Angle Plc (1st one for dual analysis lung cancer) to use with their Parsortix machine may be involved with this. Ticks all the boxes!!!!!!!!!!! "Personalised treatments".

"The plan now is to extend that alliance "into other cancer types, and into wider areas of genomics with the aim of prevention, earlier diagnosis, and personalised treatments," said the Welsh devolved government in a statement.".

https://pharmaphorum.com/news/nhs-wales-partners-illumina-genomics-drive

https://www.lse.co.uk/rns/AGL/analysis-of-ctc-dna-and-ctdna-using-illumina-assay-mqynkijrkyza9ga.html

All IMHO.

The assay panel illumina now sell for the dual analysis of CtDna and CTC's, developed recently with Angle Plc (1st one for dual analysis lung cancer) to use with their Parsortix machine may be involved with this. Ticks all the boxes!!!!!!!!!!! "Personalised treatments".

"The plan now is to extend that alliance "into other cancer types, and into wider areas of genomics with the aim of prevention, earlier diagnosis, and personalised treatments," said the Welsh devolved government in a statement.".

https://pharmaphorum.com/news/nhs-wales-partners-illumina-genomics-drive

Quite possiby.

Half year report orders are finally arriving on the back of the NICE recommendation to order the machine for point of care use "if lab test not available". As the RNS points out England's largest Hyperacute Stroke Centre are now using the Genedrive® CYP2C19-ID Kit routinely. That says it all. The lab test is clearly not fast enough. Simple as that. Why would anyone with any common sense not use the Genedrive® CYP2C19-ID Kit when you only need a cheek swab (as opposed to a BLOOD DRAW!) and you gat the result in an hour (as opposed to 6 hrs to several days!). There is no comparison.

All IMHO.

Genedrive® CYP2C19-ID Kit to England's largest Hyperacute Stroke Centre!".

But NICE recommended the Genedrive® CYP2C19-ID Kit "if a lab test is not available". So is the lab test not available at the "largest Hyperacute Stroke Centre in England"? or do the management at this massive hospital have the common sense to realise that a lab test is TOO SLOW. genedrive = 1hr, lab test = 6 hrs to 7 days!!!! Joke or what!

- No competition to the Genedrive because of the speed, and the hospitals know it. Plus there is no chance of a lab test catching up on speed. Blood draw, package up, label, get a courier etc… Crazy.

All IMHO.

A&E are open 24/7 as we know. 24 hours a day, 7 days a week. Reasonable to think that 10 stroke victims might arrive in a large busy hospital in that time, I think. Even if half that, say 5, that works out at £500 a day turnover x 7 days = about £3,500 per week to invoice. Finding out if the usually used blood thinner will work or not will prevent some secondary strokes probably saving lives too of course.

All IMHO.

Food for thought!!!!!!!!!!!!!!!!!

Gaining momentum. See half year report. This is the most positive big news about actual sales which not only is payment for the machine but regular payments for the consumables which is just excellent for the future.

1. "Northwest Anglia Foundation NHS Trusts' Peterborough City Hospital implements the Genedrive® CYP2C19-ID Kit for routine clinical use.".

2. "Growing base of initial installations for site verifications expected to lead to subsequent routine clinical use. ".

The trusts are clearly implementing the NICE recommendation at last and so orders are now gaining momentum throughout the NHS in the whole of England. Looks like over the next few months the number of orders will be in the teens and then beyond. Very good news.

All IMHO.

1. Scottish Government announcement of £800k investment to support national phased implementation program of pharmacogenetic testing of MT-RNR1 in newborn babies in NHS Scotland using Genedrive's MT-RNR1 ID Kit

2. Scottish Government:-

"Building on a successful trial at Manchester University NHS Foundation Trust, newborn babies will receive a point of care genetic test to quickly establish whether they are one of the 0.2% at risk of permanent hearing loss if they are treated with a common emergency antibiotic. This programme will begin in October and be rolled out to all Territorial Boards within 18 months. Once fully adopted over 3,000 newborn babies a year will be tested, with those that require an alternative antibiotic receiving it.".

- Genedrive® MT-RNR1 is to be implemented throughout Scotland.

3. NIHR and OLS Funding Package of c.£500k to address NICE Real World Evidence Generation Requirements for the Genedrive® MT-RNR1 ID Kit across 14 hospitals across the UK (PALOH-UK). Progressing as planned, with nine Group 1 sites live, with a further five Group 2 sites phased to go-live from May 2025.

- "Real World" testing on going. Nine hospitals using the machine already, 5 to go live from May 2025 (next month).

- This data may help with the FDA application in the USA..................

4. 11 babies identified as positive for the MT-RNR1 DNA variant since introduction of the test into Neonatal Intensive Care Units (NICU) in the UK and avoiding lifelong hearing loss resulting from aminoglycoside exposure.

- Massive savings for the NHS ALREADY. What is the cost to the NHS over a person’s lifetime if they are made deaf by antibiotic reaction shortly after they are born??? £ Millions per person, I think.

5. Distributors contracted in key international geographies, with site installations in Italy and Saudi Arabia and additional sites expected near-term.

6. Accepted on NHS Dynamic Procurement System (DPS), permitting direct procurement by regional NHS trusts

7. Breakthrough Device Designation received from the FDA. Progressing as planned, with first engagement with FDA under programme initiated.

All IMHO.

Genedrive® CYP2C19

1. Northwest Anglia Foundation NHS Trusts' Peterborough City Hospital implements the Genedrive® CYP2C19-ID Kit for routine clinical use.

- Proof that trusts see the Genedrive® CYP2C19-ID Kit is vital at point of care and are implementing its use following the NICE recommendation. Largest UK NHS trust first to implement routine clinical use. Others to follow.

2. Growing base of initial installations for site verifications expected to lead to subsequent routine clinical use.

- Other NHS trusts are implementing the NICE recommendation. Genedrive obviously see sales traction here following the NICE recommendation. Result will be income from sales of the machines and regular income from sales of consumables.

3. Market access routes and reimbursement strategies defined in key initial international target countries, including the Middle East region, with well-positioned and aligned in-country distributors, with required regulatory certification (CE-IVD under IVDR) on track for April 2025.

- Pretty obvious Genedrive is expecting significant orders from the Middle East region once the machine gets CE-IVD under IVDR certification expected THIS MONTH. Certification also opens the whole EU!

4. 510(k) route identified for regulatory submission for US market entry, with initial pre-submission engagement with Food and Drug Administration (FDA) held and feedback positive and with regulatory approach confirmed as appropriate.

- Application to FDA could happen any day. RNS expected soon to confirm.

- FDA approval could take less than 3 months from application. June or July? Distributors is USA to be confirmed?

All IMHO.

New subscription and new retail offer shares. For a Company with 2 DNA analysis machines that are already in use in the NHS. And for a Company whose machines in time will be on sale in the USA after FDA clearance. And one of those machines is unique to the USA market, so no competition at all that seems cheap!

All IMHO.

Not sure if I would go for it.

On April 4th 2024 the sp spiked to over 8p a share. On AIM a bid can't be lower than the sp in the last 12 months I believe. So under 8p bid can't happen at the moment. However after April 24th 2024 until now the sp has not gone over 6.3p. Thus a bid could come in about 6.4p or more from then on. That is what I understand.

All IMHO.

A USA Co. is bound to take GDR out. No major shareholders, so a matter of making the small shareholders an offer via the London Stock Exchange RNS system. I'm sure a bid of 8p a share would be enough. 6p a share maybe, maybe not. They could bid 6p a share then see what the response is. Any thoughts?

All IMHO.

Tick up 1.53/1.54p