Member Info for Muck165

Thanks Lucksin - well on that basis those with time (and patience) might want to watch this Webinar on IDAP delivered in October (when the scheme was launched) by all government agencies involved. Highlights for me were;

1. At around 8.30 NICE stress that IDAP is "specifically designed to identify the most impactful technology that will make the greatest difference to the NHS and patients." So that tells me all I need to know about the prospects for Upfront and 52N

2. The constant message throughout is that it's not easy to get on the scheme

3. At around 15.14 a graphic is put up which further details how the selected technologies will move through the pilot, what support they will get, and when. Part of that cycle is clinical trials immediately followed by Emergency Use Authorisation applications.

4. The 8 successful applicants were supposed to be announced in December, so the scheme is already at least a month behind! Perhaps that owes to the volume of applicants?

Point 3 is particularly interesting for me because we already know that Upfront formally kicked off their LVOne clinical trials at the beginning of November last year across a number of NHS Hospitals in the North of England, so they are already nearly 4 months into that process and well advanced into the IDAP cycle. If the results are as hoped then we could see the product achieve EUA in pretty short order. Its also important to note I think that this cuts through the delays in getting normal conformity assessments from a notified body, which is where the regulatory treacle across the whole European IVD market sits are the moment.

I'm not sure where 52N are with their trials but I know they already completed a usability study with 60 patients in October - https://classic.clinicaltrials.gov/ct2/show/NCT05852249

Note, if you want to watch it then you really only need to watch from 13.21 until 29.52. Before that is just introductions from the presenters, and after is the Q&A.

No probs Lucksin - tbh I worry about boring people on here with my posts but like you, I see real opportunity here and cant help myself!

Well, all the delayed large sells popping up tell me there’s are large sell order going through, which I think relates to the December share issue (only ratified at the GM last week).

Agree Lucksin, but I’d elaborate. IDAP isn’t just intended to fast track product into the “marketplace” - it’s intended to fast track it for widespread use across the entire NHS. If one or both of 52N and Upfront succeed, and we make manufacturing agreements (which seems likely) then it would represent a valuable annuity income with, dare I say it (!), a tier one customer.

And that would just be in the U.K. Upfront (POCKiT) completed a significant trial of its bio markers across a number of US sites in April 23, and 52N are in 2 prestigious US accelerator programs. If the NHS were to procure the tests then I think there’s a fair bet the US would too.

https://clinicaltrials.gov/study/NCT04292600?lead=POCKiT%20diagnostics%20Ltd&rank=1

Last one from me today, but I have to say I am surprised by the general lack of interest in the inclusion of 52 North and Upfront in the new IDAP scheme. Fundamentally, the scheme has been put in place to accelerate route to market for breakthrough, transformative devices so they can be quickly adopted in the NHS. Its the UK equivalent of "Accelerated Approval" at the FDA, only 8 companies are involved, and we work with two of them.

But then I suppose that's one downside of posting on a BB for an under the radar company! Good for the rest of us though.

Blogs coming thick and fast at the mo....

This latest one is all about LFT applications in animal testing. It specifically mentions two companies and their products; Zoetis, who I am certain we assist with both CRO and CDMO, and a company called Iddex that I've not come across. But the point is that I have rarely if ever seen an ABDX mention another company that we aren't helping in one way of another.

"Zoetis is the world’s leading animal health company" - https://www.zoetis.com/

As you said, we’re very much under the radar which, at least I think, is because the market sees nothing exciting happening. It’s just a boring business.

Suits me - I’m topping up down here. Our revenue is mostly on a “fee for” model at the mo. The aim of course is to get our partners commercialised and then to manufacture, which I’m assuming will generate revenue based on unit volume. Get products adopted by the NHS (that’s the whole point of IDAP) and potentially other national health services, and the manufacturing contracts should be lucrative and stable. Keep adding contracts and our whole revenue base grows and solidifies.

Watch what happens to the SP when those contracts start to land.

I’m also watching out for anything about our assisting retailers with their own brand products, something Yates mentioned a few times in the presentation. Only major retailers have own brand products…..

Just another observation, but in the presentation Yates said we need c£8-9m revenue to breakeven, the aim being to achieve that either in H2 23/24 or H1 24/25. That will be on a rolling 12 month basis.

We did £2.4m in H1 23/24, so we’d need c£5.6-6.6m in H2 to achieve that this year. That seems to me to be a bit of a stretch, but the fact he’s even suggesting we could do that by June indicates his revenue expectations for H2, which we know are underpinned by known contractual milestone payments, are much higher than for H1.

Buci - shouldn’t we have had an RNS if there had been a conversion?

It would, at least as far as I’m concerned, indicate no new raise now and that the headroom increase at the GM was just a normal routine matter for the reasons given, ie we may need to raise again before the next GM.

if i’m right ****nal then the annoying thing is the timing, because it would perhaps infer that roland delayed the jv announcement, and the subsequent price spike, until just before novum clients had they ability to trade, essentially allowing them to sell right into that spike.

I think we will find that the mass selling we saw related to the placement in December.

The original GM notice proposed three resolutions, which it explained in an Explanatory Memorandum.

The first resolution was to ratify the issue of 1,375,000,000 shares to clients of Novum. This was explained in the Memorandum as follows

“ On 5 December 2023, the Company announced it had arranged an equity capital raising with clients of Novum Securities Limited (Novum) of £1.1 million before expenses, through the issue of 1,375,000,000 new fully paid ordinary shares (Placement Shares) at GBP0.08 pence per share (Placement). The Placement was completed on 19 December 2023.

Resolution 1 seeks Shareholder approval for the ratification of the issue of 1,375,000,000 Placement Shares to subscribers, who were clients of Novum Securities Limited.”

This under the “General” section of the GM notice we’re told “ Funds raised from the Placement ARE INTENDED TO BE applied to the Company's working capital base.”

So I think the 1.375bn shares issued to clients of Novum could not be traded until the issue had been ratified at the GM. Just my view.

SV - presumably your comment was made because we invest in India, ergo you will never invest in SYN.

If you’re not invested, and you’re never going to invest, what’s your interest here beyond spreading far right political views?

No probs mate - just my opinions really. Hope all ok with you.

Worth noting a few other things I think.

In the presentation Lucksin reposted Yates was asked about our competitors.

One was DCN in the states, who we actually already have collaboration agreements with. One was BBI in Wales (who we’ve worked with). One was in Spain if I recall.

The point being that globally, these few companies represent our competition (at least according to Yates!)

Since Covid the number of test developers wanting the services we and these others offer has ballooned. Seems to me, therefore, that demand very much outstrips supply.

On 52 North, remember that not only are they in IDAP and funded by MacMillan/innovate U.K. etc, but they were recently selected to join two of the largest, most competitive and prestigious healthcare accelerator programmes in the US. I also note that they have doubled their staff count over the last year, and of course are now looking to appoint a CTO to, in part, manage relationship s with us. I have a lot of hope for 52N (as well as Upfront).

Finally, worth remembering that the geography we are seeing most revenue growth from is the US.

Completely agree.

Post Covid the light has really been shone on LFT potential across a whole host of varied and lucrative applications, and there has been an acceleration in LFT tech, and test bio marker developers wanting to use it. It was a great move for us to transition into a CRO/CDMO to become true experts in that field and be one of few able to help all those developers. We have some great things in the pipeline, the real issue being treacle like regulatory processes delaying approvals and, therefore, mass manufacturing contracts.

But those approvals and manufacturing contracts will come in time, and the new IDAP scheme will accelerate that.

As it stands, we’ve rebuilt the foundations, planted lots seeds, are at a stupidly low SP with heavily aligned directors, a low free float, and are just waiting for everything to blossom. It might be boring at the mo but with some patience this will flourish imo.

Have been looking at 52 North again.

-Received the first-ever investment for Macmillan’s new £3.5m Innovation Impact investment portfolio.

-MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards

-Now part of the IDAP pathway (which seems really significant to me)

As far as we are concerned, I notice they’re currently recruiting for a VICE PRESIDENT, TECHNOLOGY (IN VITRO DIAGNOSTICS), whose job description includes;

“Manage our partnership with a leading CRO, ensuring alignment with our development goals and timelines.”

“Lead coordination with the CRO for clinical trials, regulatory submissions, and other critical processes.”

We are that CRO. So they are recruiting to boost engagement with us.

https://salutemyjob.com/jobs/vice-president-technology-in-vitro-diagnostics-cambridge-cambridgeshire/1236396301-2/

On a broader point, the new IDAP pathway appears to be a U.K. govt initiative to identify breakthrough technologies and to accelerate access by breaking free of European medical device regulations that are clogging up the whole system and causing delays. If the current pilot scheme works then it could open up significant opportunities for us beyond the 2 companies were helping in the pilot.

This is well worth a read I think;

https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase

It sets out details about the new govt innovative devices access pathway, inc its aims, eligibility criteria, and benefits. Of note for me were;

-multiple govt agency support to progress products quickly to mkt.

-Fast track review

-The potential for “exceptional use” authorisation from MHRA.

-The criteria for getting into the scheme included; “ The use of the device in the healthcare system has the potential to be transformative” and “ The product will provide system wide benefit and be widely adopted”.

In a nutshell, this is a multi govt agency scheme to support devices with the most potential to deliver transformative outcomes across our national health service.

8 were selected. We are working with 2 of them. Fair chance we could therefore soon be making 2 tests widely in use within the NHS.

Thanks Ant

Would expect to hear about their trial results first, which was on their timeline for publication during the last quarter. Their response to you perhaps suggests those might come pretty soon.

Have you seen something Ant? The only thing I saw is that Loops CTO is having an interview shortly with a Spanish Biotec organisation to discuss the problems with the Notified Body regime under new regulations, and the delays it’s causing in getting approvals.

Just for awareness, but Salistick is now available through Apoteket (the largest pharmacy chain in Sweden). Its branded as coming from Addeira, who have rights to distribute it in the Nordic region just like we have the rights in the UK and Ireland, but unlike us they have no part in its manufacture.

Its also available through SuperPharm in Israel, again their largest pharmacy chain.

The point being that sales, wherever they may be, are likely to have an impact on our bottom line because we are making elements of the test for whoever sells it.