Member Info for Eureka01

Increased income? Tax rebate? Grants?

No income and £500,000.00 monthly spend!" Slacker, at least stop telling lies. Income from last year £500k. This year, according to Russ in the IMC presentation, "Pipeline, if converted, would see income increase significantly in 2025".

Gino stated in the IMC presentation that for FDA approval they estimated they would need around 12 months for the studies themselves and then a further year for FDA review before being accepted by the FDA for use in the US market which would bring the timeline to late 2026. However he went on to say that they are trying to expedite how much in country studies would be required to be done by seeking to use the PALOH clinical evidence. If that were accepted the approval could be much quicker.

From the NICE website:

Potential benefits of early access

Clinical: Evidence suggests that the Genedrive MT‑RNR1 ID Kit quickly and accurately identifies babies with the MT‑RNR1 m.1555A>G variant, who may be at risk of hearing loss if given aminoglycoside antibiotics. This will allow equally effective alternative antibiotics to be used instead.

Unmet need: There is currently no test available in the NHS that gives results quickly enough to inform decisions on acute antibiotic prescribing.

Resources: The long-term savings to the NHS associated with hearing loss and fitting cochlear implants could be substantial.

Other Points:

Evidence suggests that time to antibiotics is not affected by implementing the test.

Real-world data suggests the failure rate with the current version of the test is low.

The economic evidence suggests the test could be cost effective, but the upfront costs of buying the Genedrive system may be high.

The test should also be implemented in a wide range of geographical regions to include patients from various socioeconomic groups to ensure equal access.

https://www.nice.org.uk/guidance/hte6/chapter/1-Recommendations

This is what you are referring to, from the Full Year results (29/11/24):

"MT-RNR1 is now in routine use in the NHS at 9 hospitals and the NICE EVA programme via NIHR will see this increase to 14, throughout the UK nations."

https://polaris.brighterir.com/public/genedrive/news/rns/story/xzgk17w

yes, without news you and british bull**** are probably right. i did say at the end of december when the sp was 2.50p that in the absence of news we could expect some downward drift. but with a raft of news expected soon i'm staying in and will be topping up if we visit 2p again.

Some key points:

In acute clinical contexts, centralized laboratory-based testing is too slow to inform timely clinical decision making.

In this assessment, the sensitivity and specificity of the CYP2C19 ID kit was 100% (95.0-100%) and 100% (97.2-100%) respectively.

This study confirms the analytical validity of the Genedrive CYP2C19 ID kit. The Genedrive system is able to provide an accurate, rapid, non-invasive alternative to standard laboratory testing and can be used as a point of care test in the clinical environment.

CYP2C19 genotyping is not widely available from the genetic laboratories which serve the UK National Health Service (NHS) and, as existing infrastructure has been developed to mainly deliver rare disease and cancer testing in the outpatient context, results may take many weeks. Given the potential scale of CYP2C19 testing recommended by NICE and considering the acute nature of most stroke admissions, with a clear time-pressure to commence definitive antiplatelet therapy, this represents a major unmet need.

The Genedrive CYP2C19 ID Kit compared favourably to the reference laboratory test in this assessment, and it has a number of advantages over the existing POCT on the market.

Conclusion

This validation study demonstrates the Genedrive CYP2C19 ID kit to have a high diagnostic accuracy for clinically relevant CYP2C19 variation. The platform had a superior performance to the reference test, with a higher accuracy and lower failure rate. Implementation of the Genedrive CYP2C19 ID Kit in clinical practice could provide an accurate, rapid, cost-effective and non-invasive alternative to standard laboratory testing and ensures results are available in a clinically relevant format and timeframe to guide patient care.

https://www.sciencedirect.com/science/article/pii/S152515782400312X

The extra £22 billion was announced at the end of October. Hopefully the extra cash will impact the Genedrive tests. Of particular interest:

"A total of £1.5 billion will also be invested in new capacity for diagnostic tests, surgical hubs and diagnostic centres to help end long waits for diagnosis."

https://www.standard.co.uk/news/health/budget-nhs-funding-boost-hospitals-patients-b1191036.html

A couple of recent examples in the sepsis field. "Interest in the sepsis testing space was borne out by investments to companies developing tests to get faster results and improve management of sepsis patients. Cytovale received $184 million from its two most recent funding rounds to support expanded commercialisation of its test that provided results in less than 10 minutes....

Inflammatix has been preparing to launch a 30 minute test for simultaneous determination in a blood sample of infection type and severity. By September the company had raised more than $200 million in private capital..."

https://www.360dx.com/diagnostics/sepsis-test-developers-progress-commercialization-market-approvals-rapid-tests-during?utm_source=Sailthru&utm_

Remember the announcement, April 24th 2024: " Genedrive PLC on Wednesday said it has entered into a clinical trial agreement to support clinical studies to progress the regulatory approval of its MT-RNR1 product. The Manchester, England-based molecular diagnostics company said the deal is with a "leading multi-state physician organisation" based in the US, but did not disclose its name. The partnership will support clinical studies required for engagement with the US Food & Drug Administration."

So my hope, fwiw, is that with the help of our US partner we shall see some substantial funding from across the pond in the coming months for the FDA submission.

Some detailed technical analysis by Stockinvest which rates the share as a buy and concludes: "Several short-term signals are positive, despite the stock being in a falling trend, we conclude that the current level may hold a buying opportunity as there is a fair chance for stock to perform well in the short-term."

Personally, I am positive in the medium term based on news rather than technicals: Scottish rollout, new sites in the UK and abroad, CE IVD certification for the stroke test (early 2025), specialist commissioning for AIHL (April 2025) and FDA news for AIHL (early 2025). As always I bear in mind the possible need for funding by the summer of 2025 and short term there could be some downside in the absence of news.

https://stockinvest.us/stock/GDR.L

Resolution 7: To re-appoint Russell Shaw as a director of the Company

33% of votes cast were against his reappointment.

Yes, I don't anticipate any earth-shattering news coming from the AGM but elsewhere it's good to see that genomics is being pushed in the NHS. A tweet from earlier in the month: "The NHS really is world leading in genomics, with the next country five years behind us." From a presentation entitled "Embedding genomics in the NHS through a world leading, innovative service model."

https://x.com/NHSgms/status/1867147872233214096

Emerald can you please stop setting up new threads every few minutes. I counted 7 for this morning alone and we're only 90 minutes into the trading day!

GG: "with revenues not increasing very much at all" That's where you may be wrong. With Scottish rollout, Specialist Commissioning for the AIHL test which would open up the doors for a national rollout scheduled for April 2025 and CE IVD certification for the stroke test which would allow for sales in the EU and certain other countries scheduled for early 2025 sales could take off.

So

1)Less expensive

2)Quicker results

3)More accurate

4)Detected more variants

5)No need for freezer storage

Sounds like a no brainer!

The important bit:

In summary, in a cohort of 202 patients, in addition to being substantially less expensive than the laboratory platform, the Genedrive® CYP2C19 ID Kit outperformed laboratory testing with respect to (1) speed to result, (2) accuracy of LOF identification and (3) test fail rate. Sensitivity and specificity of the CYP2C19 ID Kit was 100%, with failure rate of 0.98% (three times lower than laboratory testing). In addition, the laboratory test platform returned incorrect results for eight samples (4%). Importantly, the Genedrive® CYP2C19 ID Kit identified seven patients harbouring LOF variants that would not have been detected using an alternative POC CYP2C19 genotyping platform which focuses on two specific LOF variants compared to five targeted by the Genedrive® test, or laboratory genotyping methods which also focus on these two LOF variants. Requirement for freezer storage of reagents of this alternative platform is also an implementation barrier in acute clinical settings that the Genedrive® technology circumvents.

This study confirms "that the Genedrive® System is able to provide an accurate, rapid, non-invasive alternative to standard laboratory testing and can be used as a point of care test in the clinical environment."

Good point JH. There seems to be much confusion as to what constitutes inside trading. For example, if the directors buy in the knowledge that the Scottish rollout could happen any time, which is in the public domain, then that is fine. If they had inside knowledge that the rollout was happening tomorrow, something not in the public domain, then that would be inside trading. So statements such as "I would say they have confirmation of supply to some big players for there products" and "Directors can’t buy so close to news...so nothing due now until February or March I suspect" are equally wrong.

IMO yesterday's buying is a sign of directors anticipating a brighter future.

In Japan then Stocksaint? There is an old Japanese proverb: "Even monkeys fall from trees" which is a reminder that everyone gets it wrong sometimes, even the experts! 🙂

"No income no sales. Uninvestable in the short to mid term!!" Slacker246.

From my vantage point, some 7,000 miles away, I would beg to differ. This is a great trading share if you can get it right. Over the last week we saw a rally followed by another downturn. This coincided, for what it's worth, with British Bulls recommending GDR as a buy on the 12th after rating it as a sell since 26/11. Yesterday it was rated a sell again and has now turned down.

But what's the prognosis for the longer term? A lot of news to come:

AIHL

1)Possible Scottish roll out. Any time.

2) Already 9 sites in England and this will increase to 14 under the NICE EVA programme. Due any time.

3) Sales in the EU and the Middle East. Any time.

4) FDA news. Due early 2025.

5) Specialist Commissioning which would open up the doors for a national rollout. Scheduled for April 2025

Stroke Test

1)Possible Scottish rollout. Any time.

2)Further live sites in England. Possible any time.

3) CE IVD certification which would allow for sales in the EU and certain other countries. Scheduled for early 2025.

4) Completion of the pilot for the stroke test in England. Due to complete by April 2025.

But what about the finances? As of 21/11/24 there was £3 million in the bank. Then there is the £500k grant for AIHL and the tax rebate of £700k due early 2025. Then there are the sales: in the year ending June 2024 they amounted to some £500k. Some time ago the company calculated it would reach break even on sales by the first half of 2026. On the basis of present funding and allowing for say £1m of sales in 2024/25 I calculate the cash would run out by the summer of 2025. So, as usual, the elephant in the room is the need for a fund raise. However, there is the possibility of extra income. The US partner could help out with the FDA application for the hearing test. Income from the tests in the UK, Europe and the Middle East could take off more than anticipated. So whilst a need for a fund raise is certainly a possibility , I do not regard it as a given. Certainly when I spoke to the company earlier in the year they seemed confident that another fund raise would not be needed.

AIMHO

Good find Lionel. Some of the points that came across:

Clopidogrel v aspirin probably saves 7 per 1000 patients from having a stroke within a 2 year period.

The NICE guidance has provided the evidence based recommendation,

It is a misconception that POC testing is inferior to lab testing.

The pilots will inform in terms of the approach to commissioning.