Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
We are also hearing a significant amount of misinformation about a placing. Might i remind everyone that Q1 doesn't start to 01/01/24 and ends on the 31/03/24 - lots can happen before then, as i shall detail later.
And, its a fallacy to say that any placing will be at a significant discount, as proven over the last 4 years. I'll post a history of the placing in the last 4 years later.
In any case, James has eluded to the placing being used for FDA submission. RF drawdown, the incoming tax credits, devote funding, Medtech funding, and commercial traction can be used to cover monthly cash burn.
See news flow for Dec 23 and Jan 24, summarised from the presentation with comments from James Cheek attached:
- Revenue in the UK and abroad for MTRNR-1 hearing product (Sussex Trust already life)
* Expecting to see orders from around Europe in Dec 23 (EU Market worth £46.75M annually) and more UK Trusts
- Promotion of MTRNR-1 through Health Innovation Networks
* Talks ongoing with Scotland and Wales
- Special Commissioning for MTRNR-1
* James states "Pretty much got absolute 100% clarity that it is happening" (UK market worth £8.5M annually)
- FDA registration for MTRNR-1
* James states that contracts with a US partner for FDA are being finalised and we should hear news this year or early next, on the back of extremely positive talks with the FDA (USA market worth £34M annually)
- NICE recommendation for MTRNR-1
* NICE full validation for the MTRNR-1 is being hindered by the EVO process itself and not the product. News due Jan 24 says James Cheek
- NICE review for CYP2C19
* News due Jan 2024 says James Cheek (UK market worth £8.5M annually)
- Testing in Manchester Trust for CYP2C19 and Europe
* Testing for the adverse reaction to Clipidogrel in stroke patients to roll out in Dec 23. Also being actively marketed around Europe as a research only product (EU Market worth £93.5M annually)
- Future funding activities to support FDA
* Support of US partner and specific fundraise for FDA in Q1
GLA.
Stephen11.
There is at present a significant amount of misinformation being posted on this forum.
I prefer to base my posts on facts that can be checked, cross referenced, and verified.
From 23 minutes onwards in the GDR investormeetcompany presentation James Cheek is speaking about early adoption of the MTRNR1 hearing loss test through the NHS Special Commissioning programme.
He states "Pretty much got absolute 100% clarity that it is happening...big driver is to make sure it happens as quickly as possible." For the cynics amongst you, please listen to the presentation.
What is Special Commissioning? (info taken from NHS website)
- Special Commissioning is used to ensure smaller population have access to adequate medical provision to meet their specific needs. The population size can be as low as a few thousand or as many as 100,000
* Massive tick for GDR as there are 60,000 premature babies born in the UK per year
- Certain cohorts of the products and populations are prioritised for special commissioning. These include babies, infants, and children
* Massive tick for GDR
- The NHS 2022/23 budget for special commissioning was 22.9 billion and is increasing in 2023/23
* Massive tick for GDR
In a de facto manner Special Commissioning could be as good as full NICE accreditation.
Listen to the facts folks and not the derampers who are looking to get in at a lower price.
GLA.
Stephen11.
We already have an impressive list of well respected world-wide distribution partners for the MT-RNR1 ID (Hearing loss) Kit. These partners have all went through a stringent due diligence check list by GDR, as described in the Nov 2022 investor presentation.
They now have all the products and software translated to all the relevant native languages thanks to the new CEO James Cheek.
As below:
- Turkey: Ertunc Ozcan
- Greece: Artisel
- Kuwait: Al Essa
- France: Eurocare
- Saudi Arabia: ideal idea
- Austria: Connect Medizintechnik GmbH
- Spain: PRHOINSA
- UK: Inspiration Healthcare (as we already know)
Stephen11
Can i just echo the valid point about AIM share prices being driven by sentiment - two examples below:
- May 5th 2020: GDRs SP was £2.19 (on the rumour of the COVID test - the government opted for inferior Chinese tests, but that's another story)
- Feb 12th May 2021: GDRs SP was £1.48 (on the back of the Beckman Coulter deal and FDA application for the COVID test, although unfortunately the Americans preferred their own tests).
The difference now is we have world firsts, in the AHIL and Stroke tests operating in a much less saturated market place.
The future is bright.
Stephen11.
Continued - Part 2
**Stroke Test - CYP2CI9**
- The CYP2CI9 test is being actively marketed around Europe as a research only product - to create interest around the various countries and to create early commercial traction
- A US peer reviewed study has shown that hospitilisation from an adverse reaction to Clipidogrel costs on average $8 to $20 thousand dollars per person - the CYP2CI9 test would eradicate this cost
**The Future - Near Term**
- Revenue and commercial traction for the hearing loss test imminent - as soon as Dec this year and Jan next year
- 100% clarity from the new CEO that special commissioning for the hearing loss test will happen
- Contracts being drawn up with potential partners who can help with the FDA application for the hearing loss product in a cost effective manner
- NICE full validation for the MTRNR1 is being hindered by the EVO procedure and not the product - news due Jan 2024
- NICE Review of the CYP2CI9 - due Jan 2024
- Funding: early 2024 fundraise will be specifically for FDA of the MTRNR1 - RF drawdowns, sales, and tax credits will cover the monthly cash burn, despite what the derampers say!
- More grant funding is also a possibility e.g., through MedTech etc.
**The Future - Long Term**
- European registration of CYP2CI9
- FDA registration of MTRNR1
**Conclusion**
------------------Strong Buy and hold all day long--------------
GLA.
Stephen11.
Part 1 of 2
I was extremely impressed with the new CEO, his strategies for commercialisation, and his vision for the company. Here's why:
**Introduction**
- James brings a significant level of commercial and diagnostic experience gleaned from 20 years with Roache, Beckman Coulter, and Cepheid
- He has previously worked at board level in BIDVA where he gained specialist knowledge in NHS supply chain management and procurement procedures - experience which will prove invaluable to GDR
- He was brought in to increase sales and his main remit from the board of GDR is to generate commercial traction ASAP
- The company intends to focus solely on pharmacogenetics i.e., specifically in the prevention of the prescription of drugs that produce Adverse Drug Reactions (ADRs) because the infectious diseases market is over saturated at present
- ADRs cost the NHS £2.2B in extra hospital days per year. Overall, pharmacogenetics testing could effect 30% of these cases, which in terms of health economics could save the NHS £660m per year
**Hearing Loss (AHIL) - MT-RNR1**
- The MT-RNR1 test has no known competitors at present
- The Total Addressable Market value is around £100M: UK £8.5M / EU £46.75M / US £34M / ROW £13.75M
- Last month software and training materials for the MT-RNR1 test were translated into several foreign languages (this had not been the case under David Budd's tenure). James Cheek reported that he expected to see orders coming in from European countries in the month of December 2023
- James is actively speaking to those in charge of NHS budgets in regards to getting the MT-RNR1 test commissioned nationally in the UK
- JC is speaking to regional innovation networks (e.g., in Scotland and Wales) and various health trusts to gain commercial traction in Dec 23 and Jan 24 (The Royal Sussex County Hospital, Brighton has been announced on RNS today)
- In discussions the FDA have been incredible supportive about the MT-RNR1 test and JC reported that a deal with an American partner could be announced Dec 23 or Jan 24
- Financial modelling for the hearing loss test now considers the wider social economic cost of raising a child with hearing loss
- The test also provides information on adverse drug reactions for the mother, grandmother, and siblings
**Stroke Test - CYP2CI9**
- GDR has a competitor in the market, however this is not a proper point of care test, has a longer test time, and has limited capabilities compared with the CYP2C19 test
- The Total Addressable Market is around £220M: UK £8.5M / EU £93.5M / US £67.58M / ROI 51M
- The Manchester Health Trust will be starting to use this product routinely in late Dec 23 or early Jan 24
- GDR are actively speaking to other health trusts around the UK and have garnered a considerable amount of interest
****
We're +14.29% on Hargreaves Lansdown
05-Dec-23 11:05:03 6.79 73,637 Buy* 6.25 7.00 5,000 O
05-Dec-23 11:05:03 6.79 73,637 Buy* 6.25 7.00 5,000 O
05-Dec-23 11:05:03 6.79 73,637 Buy* 6.25 7.00 5,000 O
05-Dec-23 11:05:03 6.79 73,637 Buy* 6.25 7.00 5,000 O
05-Dec-23 11:05:01 7.00 39 Buy* 6.25 7.00 2.73 O
05-Dec-23 11:04:45 6.70 193,955 Buy* 6.25 6.50 12.99k O
Let's not forget that the MTRNR1 test can and has saved children from lifelong hearing loss as it prevents adverse drug reactions from certain medications that premature babies may require. The test allows for an alternative and more suitable medication to be administered within a speedy, yet critical time frame. It's also the only test of its kind in the world.
I'm thinking that irrespective of full NICE accreditation we may see a type of de-facto adoption when between 5 and 10 NHS Trusts acquire the test around the UK.
Let's think about this!?
If Manchester, Brighton, Edinburgh, and Belfast Trusts were saving children from lifelong hearing loss it would be extremely unfair if premature babies from neighboring Trusts (Liverpool, Kent, Glasgow, or Craigavon) didn't have access to the same test. In this sense after a certain amount of adoption and success, the test should sell itself.
GLA.
Stephen11
Https://ndau-maps.github.io/UnitMap2020/
Here is a map of all the neonatal units in the UK. Wouldn’t it be great to have an MTRNR1 test machine in each location.
It will happen through commissioning some day 😊.
GLA.
Stephen11.
What we do know is when GDR starts to go up she moves at quite a pace.
Take March 2023 as just one example: On March 2 the SP closed at 21.25 and on March 20 the SP had risen to 42.6.
A 100.5% increase in 14 trading days ain't bad!
Lots in the pipeline to look forward to in Dec 23 and Jan 24.
GLA.
Stephen11.
Thanks bigAl67, harrizma, and MisterPositive - great times ahead.
James Cheek has previously worked for three of the worlds leading diagnostic companies. That is:
Cepheid - Revenue for 2022 - $4.3 Billion
Beckman Coulter - Revenue for 2022 - $4.7 Billion
Roache Diagnostics Division - Revenue for 2022 - $17.7 Billion
In roles within these companies he had extensive involvement in selling directly to the NHS. Additionally, his experience from being a Director of the British In Vitro Diagnostic Association (BIVDA) should prove invaluable, given this organisations close working relationships and previous collaborations with the NHS.
GLA.
Stephen11.
Continued - Part 2
**Stroke Test - CYP2CI9**
- The CYP2CI9 test is being actively marketed around Europe as a research only product - to create interest around the various countries and to create early commercial traction
- A US peer reviewed study has shown that hospitilisation from an adverse reaction to Clipidogrel costs on average $8 to $20 thousand dollars per person - the CYP2CI9 test would eradicate this cost
**The Future - Near Term**
- Revenue and commercial traction for the hearing loss test imminent - as soon as Dec this year and Jan next year
- 100% clarity from the new CEO that special commissioning for the hearing loss test will happen
- Contracts being drawn up with potential partners who can help with the FDA application for the hearing loss product in a cost effective manner
- NICE full validation for the MTRNR1 is being hindered by the EVO procedure and not the product - news due Jan 2024
- NICE Review of the CYP2CI9 - due Jan 2024
- Funding: early 2024 fundraise will be specifically for FDA of the MTRNR1 - RF drawdowns, sales, and tax credits will cover the monthly cash burn, despite what the derampers say!
- More grant funding is also a possibility e.g., through MedTech etc.
**The Future - Long Term**
- European registration of CYP2CI9
- FDA registration of MTRNR1
**Conclusion**
------------------Strong Buy and hold all day long--------------
GLA.
Stephen11.
I've been very busy over the past few days, but have now taken the opportunity to review last weeks presentation in granular detail for current and potential shareholders. I was extremely impressed with the new CEO, his strategies for commercialisation, and his vision for the company. Here's why:
**Introduction**
- James brings a significant level of commercial and diagnostic experience gleaned from 20 years with Roache, Beckman Coulter, and Cepheid
- He has previously worked at board level in BIDVA where he gained specialist knowledge in NHS supply chain management and procurement procedures - experience which will prove invaluable to GDR
- He was brought in to increase sales and his main remit from the board of GDR is to generate commercial traction ASAP
- The company intends to focus solely on pharmacogenetics i.e., specifically in the prevention of the prescription of drugs that produce Adverse Drug Reactions (ADRs) because the infectious diseases market is over saturated at present
- ADRs cost the NHS £2.2B in extra hospital days per year. Overall, pharmacogenetics testing could effect 30% of these cases, which in terms of health economics could save the NHS £660m per year
**Hearing Loss (AHIL) - MT-RNR1**
- The MT-RNR1 test has no known competitors at present
- The Total Addressable Market value is around £100M: UK £8.5M / EU £46.75M / US £34M / ROW £13.75M
- Last month software and training materials for the MT-RNR1 test were translated into several foreign languages (this had not been the case under David Budd's tenure). James Cheek reported that he expected to see orders coming in from European countries in the month of December 2023
- James is actively speaking to those in charge of NHS budgets in regards to getting the MT-RNR1 test commissioned nationally in the UK
- JC is speaking to regional innovation networks (e.g., in Scotland and Wales) and various health trusts to gain commercial traction in Dec 23 and Jan 24 (The Royal Sussex County Hospital, Brighton has been announced on RNS today)
- In discussions the FDA have been incredible supportive about the MT-RNR1 test and JC reported that a deal with an American partner could be announced Dec 23 or Jan 24
- Financial modelling for the hearing loss test now considers the wider social economic cost of raising a child with hearing loss
- The test also provides information on adverse drug reactions for the mother, grandmother, and siblings
**Stroke Test - CYP2CI9**
- GDR has a competitor in the market, however this is not a proper point of care test, has a longer test time, and has limited capabilities compared with the CYP2C19 test
- The Total Addressable Market is around £220M: UK £8.5M / EU £93.5M / US £67.58M / ROI 51M
- The Manchester Health Trust will be starting to use this product routinely in late Dec 23 or early Jan 24
- GDR are actively speaking to other health trusts around the UK and have garnered a considerable amount of interest
****
Thought James was like a breath of fresh air today, and is clearly going to aggressively chase sales and commercialisation.
I'll do a more detailed message on this when my schedule permits.
I was really angry about an admission made by James of a major error made by the previous CEO David Budd.
Basically, the MT-RNR1 hearing loss kit was being marketed around the world without being translated into the relevant foreign languages. This was a real primary school, schoolboy error. Instructions and merchandising were not translated into local languages until last month.
This is unbelievable and unforgiveable.
Stephen11.
😂 Thanks for the reply Stockpick, but was more interested to hear about your answer to the one about cash flow?
Your good at evading questions?
Have you ever thought about going into politics?