Member Info for JimiHendrix

The company have been guiding investors towards June 2026 for FDA submission of the stroke/CYP2C19 test.

Is anybody in contact with Nigel by any chance who might be able to confirm if this is still on track?

“FDA 510(k) submission for Genedrive® CYP2C19 currently anticipated around June 2026, pending completion of studies, with an expected 3–4 month review period post submission.”

Thanks!

The real spread is much tighter than advertised, it’s about 1.27 to sell.

It’s because there is already a similar device (though inferior) approved by the FDA so it’s an easier more straightforward process. But for RNR1 they want NICE full recommendation first as I believe the evidence generated fit it will support the FDA submission.

No it’s just people moving shares to their ISA

The reform that starts from April is the National HealthTech Access Programme, where NICE says a small selection of high-impact technologies will be reimbursed and made available more consistently across the NHS. Separately, the Innovator Passport policy is meant to stop repeated local assessments once one NHS organisation has already assessed a technology. That should reduce friction, especially for a test like CYP2C19 where there are already pilot sites and implementation materials.

I think it’s very plausible we could see new HASUs going live in April/May and then a gradual increase in adoption over the year. The FDA submission in June should give us a big boost, along with a positive decision late summer/early autumn.

*of (anyone know how many he had before today?)

Mysterious holdings RNS as it’s unclear if Ivor’s previous position. Has he bought or sold? The share price dropped suggests he has sold some.

Genedrive has announced a fundraising at 1.0p per share, comprising a £3.5m cornerstone subscription from major shareholders David Nugent and Robert English, a £0.5m institutional placing via Peel Hunt, and an open offer of ~£1.5m for existing shareholders (8 new shares for every 55 held), alongside conversion of Nugent’s £0.5m secured loan into equity at the same price (which would release the debenture if the conditional elements complete). Proceeds are earmarked for commercial expansion (UK/Europe/Middle East), manufacturing scale-up, usability refinements, and progressing the CYP2C19 FDA 510(k) submission targeted around June 2026. The supportive insider participation is a positive signal, but there’s a key caution: only £0.6m is “firm” (not dependent on shareholder approval), while the larger elements require a General Meeting; the RNS warns that if the conditional parts don’t complete, cash runway would only extend into March 2026, potentially forcing further financing on less favourable terms.

I don't have full access to the 3 page report, I can see the paragraph overview though and it sounds positive.

"Further diamond drill holes at the MB01-N target continue to expand the footprint of gold mineralisation and in addition to expanding the dimensions of the MB01-N system, the results clearly demonstrate that mineralisation remains open in all directions and to depth. MRE on the way in Q2 which could push Mbe over 1Moz."

Dave, that’s referencing the small number of shares left that the company can issue for a placing without needing further shareholder approval to allot more shares (which they’ll need to do to raise £6m worth).

I believe DN is buying on the open market simply to increase his position and support the share price perhaps. His confidence speaks volumes, though at the same time he can’t know specifics about what’s coming as otherwise he wouldn’t be allowed to buy any. He must have liked what he heard and I imagine saw nothing indicating that the company won’t achieve the goals they’ve already told the market about.

DN has increased his holding to 17% from 16% :)

Mrave, that was my initial thinking, though now I’m included to believe this…

“The wording leans toward “whatever the market is when we actually price/launch it”, not “freeze today’s price forever.”

They say they’d proceed “at, or around, the current share price (including higher)” while also noting the terms/structure are still to be finalised. That “current” is naturally read as current at the time the deal is priced, i.e., when the bookbuild/open offer details are agreed and announced”

The 2 largest shareholders for starters, £3m at or around the current share price (including higher). I would imagine there is substantial news around the corner, that they may be privy to. Premium to what ever the current price is when announced might look very cheap by the time a GM is called to vote any necessary resolutions through, or as further news is announced.

I’m thinking the share price could return to a higher level now. With our main shareholders willing to pay a premium for their fundraising shares, then it’ll surely be a premium priced placing as why would the company ask them to pay less.

The thing that’s pushed the current price so low is fear over a discounted placing. I would not be surprised to see the price climb much higher now, 1.5p+

So around 85p or higher… that’s pretty excellent news.

Premium or around the current price…

“The parties have indicated that they would be willing to proceed with the Equity Raise at, or around, the current share price (including higher)

DN must like what he has seen and heard since becoming an insider as otherwise he would have not voted in favour of the resolutions. This is all great news imo.

Stocksaint, I've been thinking along similar lines and have come to the opinion that the reason DN loaded up substantially between 20-50 was simply because he was unable to participate in the placing. He said something along the lines of (apologies I don't have his post to hand to quote) that he intended to take part and expressed interest but when he called the company back a day later or so all the shares were gone, he had been cut out of the loop. If he had taken part he would obviously not have then gone on to vote NO to the placing. He voted NO to stop his holding from being heavily diluted, and many shareholders were in the same boat so voted similarly... however without DN's vote the placing would have gone ahead.

I expect very much that DN will be part of the next placing around the Springtime, and the price will likely be at a discount to the share price at the time, though I imagine not quite as horrific as the last, if possible.

Well we know they’re going to do a big raise 6 months time so I’d imagine that will be when his loan is converted, unless they do another fundraise in the Autumn. Either way it’ll likely be on same terms as that raise, so for example if they do a placing at 0.5 in May that will be the price his loan is converted at.

The two big things I was expecting to happen early 2026, and to considerably move the share price up before long term funding is announced are now happening later so I also feel it may drift.

1. PALOH evidence generation for RNR1 – thought this would be very early 2026 and in time for potential national commissioning as part of the new medtech funding pathway coming in April. But the programme is not expected to complete until about May I think Gino said, which means any commissioning decision will be months afterwards.

2. FDA submission for CYP2C19 - also pushed to Q4 FY26 ish.

In the meantime we might see a few new adopters announced but I'm not expecting anything significant (could be wrong though) until routine lab testing begins nationally, when I expect there will be pressure on HASUs to take up POC. But as has become very familiar, the big elephant in the room will be a potentially large fundraise announced somewhere around Feb-April 2026 I would imagine.