Member Info for JimiHendrix

I’m expecting revenue for the current financial year to June 31st to be in the region of at least £1m (including the revenue expected this month). So using a multiple of 10, plus what should soon be approx £3.5m cash in the bank, the mcap ought to be more like £13.5m right now. That’s not taking in to consideration further sales, Scottish rollout and the general huge potential… It’s way undervalued at the moment at £8m.

There’s loads of news due this month.

I understand sites are buying 12 month supplies of the tests rather than weekly.

*additional £1.5 million !

I estimate they’re likely to receive an additional £1.5 this month for the tax credit, 9 renewals and 5 new NICUs.

It’s interesting that since May 31st 2024 they have mentioned strategic M&A as part of their strategy.

I think it's the third possible reason from your list, Eureka. The reasons being they had previously said that they were expecting CE-IVD to be received towards the end of Q1, so that is looking like a few weeks late and the following will be contingent on receiving that...

"progressing through early stages of customer adoption sites, inclusive of conversion of distributors and users considering using the comparator PoC test to ours."

Additionally the £700k tax credit was received mid-march last year so I think it's simply that there was an unexpected gap that needed to be filled with a small placing.

I'm not sure exactly what to think of special commissioning at the moment, they certainly gave the impression it was on track for April so perhaps it is a process that begins in April rather than immediate national rollout in April. We know they will roll out to 5 new NICUs in April (for testing starting 1st May) and we know the existing 9 NICUs will need to renew their annual supplies also in April because their funding was only from 1st Nov - 1st May. Maybe the existing 9 NICUs will receive new funding from the NHS which could be the start of special commissioning, I'm not sure, either way things are going in the right direction and we should hear more about the Scottish rollout in time too.

I didn’t even receive the offer this time, presumably my broker wasn’t included in their partners. They must have been pretty confident the offer would be taken up.

Gloria, lol neither.

If they do a larger fundraise it will be around Autumn time and by then I expect the shareprice to be much higher than where it currently is. That will then hopefully see them through to full NICE recommendation and fast widespread adoption for RNR1.

Need to bare in mind the increasing recurring income from both tests and the reduction in cash burn expected as they convert sales pipeline this year.

Indeed! I’m particularly excited about the recurring revenue on top of new adopters, as for an example in April we should see 9 NICUs renewing their supplies of the RNR1 ID Kit which I expect will be in the region of £450k plus £250k for the 5 new NICUs coming aboard.

So likely £700k from sales (plus another £700k tax credit of course) all in April.

Hopefully the stroke pilot implementation guide, due in April, will trigger several more stroke centres to adopt CYP2C19.

NICUs currently utilising the Genedrive MT-RNR1 Test:

1. Saint Mary’s Hospital, Manchester – Implemented in October 2022.

2. North Manchester General Hospital – Adopted in July 2023.

3. Wythenshawe Hospital – Also began using the test in July 2023.

4. Royal Oldham Hospital – Orders placed in May 2024.

5. Stepping Hill Hospital – Orders placed in May 2024.

6. Royal Bolton Hospital – Orders placed in May 2024.

7. Royal Albert Edward Infirmary – Orders placed in May 2024.

8. Tameside General Hospital – Orders placed in May 2024.

9. Royal Sussex County Hospital, Brighton – Adopted for routine use in December 2023.

5 more NICUs spread over all UK nations, adopting from 1st May, to be announced shortly.

Great info Prion, thanks.

Kevin, Genedrive has already said that they believe they will actually receive about £500k from the PALOH UK grant.

Had a think about the £500k income for the PALOH UK evidence generation study as I expected them to have this, however their income for that period was 350.

It’s pretty obvious how it’s worked out though. The existing 9 sites are funded for the first 6 months and the second group for 12 months beginning May.

So they will have likely received about £225k for the existing 9 sites for 6 months (approx £50k per site per 12 months divided by 2) and then another £275k will be received before May for the 5 new NICUs taking part in group 2 for 12 months (so approx £50k per site per 12 months plus installation costs).

9 * 50,000 / 2 = £225,000

5 * 50,000 = £250,000 + £25k installation costs.

So that’s another £275k to come in the coming weeks aswell as £700k tax credit.

Also presumably the 9 routine adopters will be buying another 6/12 months supply too which would equate to another £500k on top of that, coming by May.

It sounds right, but let me know if I’ve miscalculated!

Lol, honestly this will likely be in the mid 2s again within a couple weeks. So much good stuff to come.

All truths coming from us.

I didn’t expect the fundraise so soon, my belief was based on previous years of raising the month before cash runs out. But on a positive note, including the tax credit and 5 new NICUs from May, plus renewals they should be cashed up for well over 6 months now during which time I hope the stroke pilot integration guide gives a big nod to point of care testing as that could be quite a significant income. Then there’s income from Scotland too.

At the current price with all the above to come and more, it’s looking very attractive imo.

That should be… Also regarding CYP2C19, 510k FDA clearance can take 90 days once submitted. There’s a good chance they’re waiting for CE-IVD before submitting to FDA.

Also regARDING CYp2C19, 510k FDA clearance can take 90 days once submitted. There’s a good chance they’re waiting for CE-IVD before submitting to FDA.

Looking at some of the positives, we now have the following coming up…

1. 1. Implementation guide

2. Tax credit (expected in coming weeks)

3. MT-RNR1 ID Kit further five Group 2 sites phased to go-live from May 2025

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

5. Regulatory certification (CE-IVD under IVDR) on track for April 2025

6. growing base of initial installations for site verifications leading to expected routine clinical use.

7. Ahead of CE-IVD certification we have invested significant resources in defining the market access and reimbursement routes in target European & Middle East countries, onboarding of qualified distributors and are progressing through early stages of customer adoption sites, inclusive of conversion of distributors and users considering using the comparator PoC test to ours.

8. FDA progress

My guess is they are possibly waiting on CE-IVD certification and results of the pilot study (April) before submitting...

"FDA states that their goal is to make a decision on a 510(k) submission within 90 days after they receive it. However, this timeline excludes any “hold days” which can occur for a number of reasons, including an Additional Information Request during the substantive review."

As of the latest available information, Genedrive has not yet submitted their CYP2C19 test for FDA 510(k) clearance. The company has indicated that they have had early pre-submission engagement with the FDA and received positive feedback, confirming their regulatory strategy, but the submission itself is still in the planning stages.

There are a few potential reasons for the delay in submission:

1. Pre-Submission Phase: Genedrive is still in the pre-submission phase, engaging with the FDA to ensure that all necessary data and documentation are in order before submitting. This phase helps clarify the FDA's requirements, which may involve collecting additional data or refining test results.

2. Ongoing Validation and Verification: The company may still be finalizing additional validation or clinical trial data for the test, especially to meet FDA's stringent requirements. This could include collecting more evidence on the test’s accuracy, clinical performance, and safety.

3. Regulatory Strategy Alignment: Genedrive may be aligning the submission timeline with other regulatory goals or market opportunities, like their CE-IVD certification in Europe or ongoing efforts with other markets (e.g., the UK or the Middle East).

4. Other Priorities: Given that the company is simultaneously pursuing regulatory approvals and adoption in multiple regions, their resources may be allocated across different markets.