Member Info for Eureka01

A reminder of where we are at present and likely to be in the coming year:

MT-RNR1

Present Status:

1)The MT-RNR1 kit is currently in use across 14 UK hospitals within NICU settings.

2) Scottish Implementation: Phased implementation which began in October 2025 across all NHS Scotland Health boards, facilitated by the Accelerated National Innovation Adoption pathway.

3) Ongoing PALOH-UK programme.

The Future:

1) NICE Review Completion: The PALOH-UK programme, which is evaluating the use of the MT-RNR1 ID Kit to prevent antibiotic-induced hearing loss in newborns, is scheduled to complete by July 2026, with NICE review following shortly after.

2) Further regulatory approvals in key international target markets in Europe and the Middle East are expected in FY26.

3) After receiving Breakthrough Device Designation, Genedrive is targeting a de novo submission pathway to the U.S. FDA for the MT-RNR1 ID kit, with planning focused on the end of calendar year 2026.

4)NHS Tender Notice Publication Date: Anticipated by Genedrive for January 1, 2027 according to last weeks announcement.

5) Go-Live Target Date: Expected around July 1, 2027, contingent on final NICE guidance.

CYP2C19

Present Status

1) The CYP2C19 ID kit has been implemented or piloted in at least five NHS hospital locations or trusts in the UK.

2) Current trial in acute coronary/cardio patients ongoing in Manchester hospital.

3) Genedrive is actively preparing its FDA regulatory submission for the CYP2C19-ID Kit.

The Future

1) FDA 510(k) submissions in the US, with expectations for review around June followed by a review period of 3 to 4 months.

2) Conclusion of current trial use of CYP2C test in acute coronary/cardio patients, ongoing in Manchester hospital.

3) Further rollouts across other NHS trusts are expected for stroke patient care.

4) Commercialization of the CYP2C19 kit in the Middle East and other international markets where UKCA certification is recognized.

Plenty to look forward to!

Those that hark back to big rises in the past forget that the company had a much smaller market cap and therefore big rises came more easily. However there are many drivers which should IMO impel the sp further over the course of this year.

1.Expansion of NHS Use: Following the implementation of the CYP2C19 ID Kit at the North Bristol NHS Trust this month, further rollouts across other NHS trusts are expected for stroke patient care.

2.NICE Review Completion: The PALOH-UK programme, which is evaluating the use of the MT-RNR1 ID Kit to prevent antibiotic-induced hearing loss in newborns, is scheduled to complete by July 2026, with NICE review following shortly after.

3.Commercial Rollout Abroad: The company is actively pursuing commercialization of the CYP2C19 kit in the Middle East and other international markets where UKCA certification is recognized.

4.US FDA Pathway: After receiving Breakthrough Device Designation, Genedrive is targeting a de novo submission pathway to the U.S. FDA for the MT-RNR1 ID kit, with planning focused on the end of calendar year 2026.

5.Regulatory Reviews: Further regulatory approvals for additional products in key international target markets in Europe and the Middle East are expected in FY26.

Genedrive is powering ahead on two fronts:

"Great to be at Southmead Hospital (North Bristol NHS Trust) today, working with the stroke team ahead of implementation of our rapid Genedrive® CYP2C19 ID kit.

Southmead treats around 1,500 stroke patients each year. Introducing rapid point-of-care genetic testing will help clinicians identify patients who may not respond to the current standard of care, enabling more individualised treatment decisions to improve patient outcomes."

"Why time matters in neonatal care.

In suspected sepsis, clinicians often have minutes to make treatment decisions. But for a small number of babies, standard antibiotics can lead to profound, irreversible hearing loss.

genedrive's rapid MT-RNR1 testing, developed with NHS partners, helps bring that genetic insight into the moment it’s needed, with results in around 30 minutes.

Routine use in Manchester has already shown a prevalence of around 1 in 364 babies at risk. At a national level, it is estimated that up to 200 babies each year could be spared lifelong hearing loss through timely testing.

This is prevention at its most immediate, giving clinicians the information they need before treatment decisions are locked in." https://www.linkedin.com/company/genedrive-plc/posts/?feedView=all

Fair points, Mikodx, but what have David Nugent and Robert English seen that they are prepared to invest in the company to the tune of millions? Robert English now owns 232 million shares or 14.46% of the company and David Nugent now own 395 million shares or 24.65% of the company.

I doubt they would be investing so much in the company if they thought the SP was going to stagnate.

You've been posting "news about to drop" for the past two weeks. Say it often enough and it will eventually happen!

Interesting situation. The three major shareholders now hold 42.44% of the company between them. Could they act in concert to gain control of the company? Major shareholders are allowed to act in concert but doing so triggers strict regulatory oversight under the UK Takeover Code, primarily governed by the Takeover Panel.

Https://www.londonstockexchange.com/news-article/GDR/holding-s-in-company/17498803

Another major shareholder. The word is spreading and confidence growing!

Mr David Medlock 3.3%

Actually many of the "buys" are sells. I did a couple of dummy trades just now: 1.097p to buy, 1.094p to sell.

This is where we hope to be later in the year. Lex Diagnostics, another UK company, submitted their POC test for influenza for FDA clearance in June 2025. This month they received FDA 510(k) clearance. Genedrive announced this month that it plans to submit a 510(k) application for its CYP2C19 test around June 2026. The CYP2C19 ID Kit as already received Breakthrough Device Designation from the FDA, which is designed to speed up the development, assessment, and review process. Following the submission, the company expects a 3–4 month review period. Final approval could potentially occur in late 2026. The statement by the Lex CEO could equally apply to Genedrive:

"This groundbreaking achievement is a result of several years of innovation, problem-solving, and dedication to our mission to make molecular diagnostics faster, simpler, and more accessible. We believe our VELO system will redefine point-of-care testing by equipping healthcare providers with lab-quality results in a few minutes."

https://www.medicaldevice-network.com/news/lex-fda-clearance-velo-system/?cf-view

Thanks David. I'm a few thousand miles away from the action but your support is much appreciated!🙂

Not sure where you get the 2.5p from. According to another poster who spoke to DN, he has some way to go before he breaks even. If he had tried to buy large quantities in the market at .2p the price would have quickly moved against him.

He could have but he would have been obliged to offer the highest price he paid over the last 12 months which would have been considerably higher than .20p!!

DN, if it is he, is buying on the dips. Earlier today the sp was down 7%, then the million share buys came in and now up 2.3%. Quite a turnaround!

I like those 1 million share buys (4 of them). DN topping up again?

There are certainly shares to buy at present. I just topped up with 200k. No ramp intended!😁

Backwardation. 1.084p to buy, 1-087p to sell. A two way pull at present which includes a million buy.

Apologies, I hadn't included the 400 million shares added in the placing late last year. Yes, that makes the 85p even more absurd.

Just to put the ridiculous 85p to bed, there are 625 million shares in issue at present and many more to come. So just on todays numbers an 85p share price would give a market cap of £531 million.

I think not.

"@Eureka01 if the share is so bad sell and move on. You people are really boring.U" You obviously didn't take time to read the rest of my post where I pointed out 6 positives from Monday's announcement. It's mindless rampers who do a disservice to all.