The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.
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 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.
Additionally, the initial orders will support genedrive's international distribution partners in promotion and in-country evaluation activities in their respective countries, to provide more extensive access to this life-changing test.
Here's the list of distributors i had previously:
- 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)
Interestingly, the Netherlands are an additional international partner. Saudi Arabia is also an extremely lucrative market for private health care, especially with all the foreign workers and families in the likes of the oil and petro-chemical industries.
Stephen11
See news flow for Dec 23 and Jan 24, summarised from the presentation with comments from James Cheek:
- 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.
Stampee1,
In a nutshell, certain types of medication, when administered to premature babies create an Adverse Drug Reaction (ADR), that can lead to deafness.
The Genedrive test is able to distinguish, in a time critical period of 26 minutes, if such a ADR would take place. In this instance an alternative medication would be administered. Importantly, this also lets the maternal line know of the same ADR.
Not sure of the brain damage claims you mention, though this may be for bilateral white matter loss, in conditions such as CP.
GLA.
Stephen11.
See news flow for Dec 23 and Jan 24, summarised from the presentation with comments from James Cheek:
- 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.
James Cheek stated in the investmeetcompany presentation that GDR are going to stay well clear of the infectious disease market as its way to competitive and oversaturated.
The Adverse Drug Reaction market is were GDR are positioned with two unique, point of care, world beating products that are first to market and about to gain a significant amount of commercial traction.
A great time to be invested in GDR.
GLA.
Stephen11.