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Link

https://bmjopen.bmj.com/content/14/8/e087130

Just a little update here, with this published on Friday. It an update manuscript relating to ongoing U.K. clinical trials for Upfront’s RADAR study.

Points of note for me;

265 of the total 552 patient cohort had been enrolled by March (when the manuscript was sent for review.

“Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.

The study is expected to report by the end of 2024.”

Remain excited by this one. It’s been developed in full conjunction with the NHS, is in IDAP so pretty much earmarked for widespread NHS use, and is already in manufacturing within ABDX. Oh, and from the links earlier in this thread it seems an application to the FDA for breakthrough designation has likely already been made.

The piece references Steve Roest and his company PocDoc, which has a cholesterol test coupled with a digital reader that integrates with the NHS. They are the best example I’m aware of where testing can effectively ease NHS pressure whilst at the same time maintaining public health coverage.

It caused me to remember that Roest did an hour long interview with Yates last year. It’s worth listening to if you have the time. Having listened again, some key takeaways were;

- Yates/Hand attracted VCT investment into their previous business, Cozart before selling it. Makes me wonder if VCT’s joined in the ABDX raise given the small discount and specific references to VCT tax treatment in the launch RNS. Great if they did.

There was a focus on digitising what are essentially analogue tests, and the need to integrate digitally with the NHS. Interesting given that part of our raise is earmarked for AppDx, which we hear little about but which clearly remains a focus for the company. “ up to £3.0 million of the proceeds of the Placing will fund additional product development alongside the Group's patented AppDx® smartphone technology”

Comments about large export opportunities.

ASI say, worth a listen.

https://rss.com/podcasts/healthtechhour/933983/

A pretty balanced article I thought…

- NHS is becoming overrun and access to alternative diagnostics is part of the trajectory.

The same criticism - “do they work?” Well thats been a problem, but the post pandemic innovation explosion is already delivering huge progression in performance.

And just a final one, but Crest have been lauding their sustainability accolades recently, culminating in this;

https://www.linkedin.com/posts/crest-medical_sustainability-goldmedal-ecofriendly-activity-7227252272982884353-Zb_k?utm_source=share&utm_medium=member_desktop

The point isn't that they are wining the awards, its why they are striving to do so.....

"an EcoVadis score is extremely important to our business and our customers, including the NHS, wholesale traders and our retail partners who demand transparency and sustainable practices in everything we do."

Its just an example of how sustainability is driving retail and NHS thinking, and ergo those that want to supply them. Not a bad environment to be launching Eco-Flo into.

And for anyone interested, the WHO put out their 2024 report on STI/STD infections last month.

https://iris.who.int/bitstream/handle/10665/376814/9789240094925-eng.pdf

Its a long read but there is a clear focus on rapid testing. A fantastic market to launch 4/5 new products into, as we will through FOFH.

Not surprised given the market we're in. This was put out a couple of days ago

https://www.biospace.com/rapid-diagnostics-market-poised-to-hit-usd-280-03-billion-by-2033-fueled-by-20-8-cagr

Rapid diagnostic market to hit $280bn by 2033 fuelled by compound annual growth of 20.8%, with LFT's accounting for 36% of the current market.

Have a good weekend all

Am a little confused by the negativity there....

If I'm reading things correctly we have nearly £600k of contracted FY25 revenue with just shy of 11 months to go until year end. Our costs look to be c£1.2m a year so it seems to me we have a great chance of at least cash flow breakeven if only a modest number of new contracts can be signed. And that's all in a very positive environment for our services where we might reasonably expect heightened demand.

But then I'm new here so likely ignorant of matters causing the negativity...!

Thanks Laura. To be honest though it’s not just the “where we are” that interests me, it’s the “where we could get to”. PYC are firmly swimming with the tide behind them, at least in my view.

I have! Been looking at it for a while but took the plunge. Opportunities seem large. Another quote from the piece I posted

“Pharmacologically informed modeling and simulation approaches, as reflected in the model‐informed drug development (MIDD) framework, have the potential to greatly improve dose optimization practices in oncology drug development. 20 Within the scope of Project Optimus, the utility of MIDD strategies is underscored in their support for more adaptive study designs, integration of preclinical insights, real‐time assimilation of PK and PD data, validation of PD markers, and the comprehensive utilization of all available data to delineate an appropriate dose range for further exploration. Nevertheless, it is important to acknowledge that developing and calibrating these models can be complex and computationally demanding, requiring significant amounts of data, expertise, time, and resources. Also crucial for successful implementation is an enterprise‐wide commitment of the patient‐focused value proposition of investing in a model‐informed dose optimization approach and commitment that transcends beyond the clinical pharmacology and pharmacometric communities of practice”.

Interesting academic piece from March. Says it all really…

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11098159/

“Project Optimus provides a unique opportunity for stakeholders in the field to prepare for the new era of a more rational, model‐informed drug development‐driven approach to dose optimization in oncology clinical development. As quantitative drug developers, it is important to proactively take steps toward readiness for this paradigm shift with progressive changes in the design, conduct, and interpretation of clinical trials.“

The key point for me here is that Optimus represents a (relatively) new FDA requirement for oncology companies to design trials to identify an optimal dosing regimen rather than just an MTD. It, alongside the move to personalised medicine, should create real opportunity for PYC. We do represent an additional cost, but if we can demonstrate that that cost accelerates approval then in the grand scheme of things, it will be money very well spent for Pharma’s.

Possibly the more interesting thing is to compare the latest shareholders with those listed on the 2023 confirmation statement. You can see who’s come in over the last year, but also notice that a number of the existing investors increased their holding in the latest funding round.

Interesting IVDeology post today about US regulation. Looks like the US might be replacing U.K./EU as the preferred first authorisation route.

https://www.ivdeology.co.uk/2024/08/08/us-ivd-classification-how-different-can-it-be/

We have the GM on Monday, with placing stock hitting the market Wednesday. Its a lot of stock, being 42% or so of current issued stock and so I was just wondering what others views are on what's likely to happen.

Personally I think the very small discount indicates we have attracted longer term investors who saw the raise as something to fuel expansion in a growing business rather than to bail out a struggling one. I just can't see it was attractive to flippers. That being the case I'm hoping II's have bought in and we will perhaps see some TR1's. We could I suppose also get final confirmation about whether or not the Directors participated.

The consideration shares aren't an issue because they're subject to a lock in. And anyway, why would CS (or IVDeology for that matter) accept paper at pretty much prevailing prices unless they believed in our prospects over the longer term.

Sorry, here’s the link to the post - well worth going through the comments from around the world

https://www.linkedin.com/posts/matthew-courtney-5ab14879_i-am-excited-to-share-that-crest-medical-activity-7196449692870758400-N9QC?utm_source=share&utm_medium=member_desktop

Just on Crest again, but it’s worth having another look at the LinkedIn post they put out announcing the Salistick launch in Boots. The post itself isn’t the interesting bit, it’s the 3,335 reactions (which is massive), and the 168 comments.

I haven’t read through all the comments, but these replies from Crest immediately stood out.

“ yes we are looking at the US market however have a few registration hoops to overcome before we can bring this to market in the States” (from 2 months ago)

“Thanks Sukie, we are not stopping here with either looking at how we can adapt the saliva testing technology for other rapid result tests, and we are also looking at announcing a sustainable version of the traditional PTK and OTK kits along with some new deficiency and ailments tests … watch this space!” (from 2 months ago - Eco-Flo possibly?)

“ thanks we are looking at all types of future tests and hope to be able to release details in the near future of the next to be launched within the range which we believe will be game changes in terms of diagnostic tests” (from 2 months ago, and clearly signalling further expansion of Boots own brand products)

“ appreciate the feedback Mahesh, hopefully the first of a number of saliva based tests we will be bringing to the market in the next 12-18months” (from 2 months ago)

And plenty of the comments came from people wanting to distribute in other global jurisdictions.

Our relationship with Crest Medical might also help with growth (they were the company holding the Boots supply agreement. We supply them, they supply Boots).

Well, according to their website they "supply well known retailers across the UK, USA and Europe. They also have a Medical Device Certified Warehouse in the US.

If they already supply Boots, they may already supply Walgreens (all part of the same global alliance). So, when Salistick finally gets FDA approval (assuming it does), we potentially have routes into the US both through Crest, and RAF Solutions.

An interesting one this time to really understand all the steps in the CDMO process.

https://www.abingdonhealth.com/essential-stages-of-a-validated-lateral-flow-development-journey/

I noted this bit in particular, in the Tech Transfer part of the process.

"The batches manufactured are used for performance evaluation work that includes both analytical studies and clinical (where necessary) studies. Abingdon’s end-to-end regulatory support services runs in parallel with this process and continues after the batch production to gain your market approval."

We are using £1m to invest in our analytical capabilities. Seems to me that is so we can do all of the necessary validation testing in house for tests we've put through into manufacturing, and so potentially reduce time to regulatory approval.

Yep - the progress here from just a couple of years ago is incredible. Right sized the business. Focussed our business model. Got ourselves on a stable financial footing and into cash flow breakeven.

Only then, when prudent, did we choose to raise at a ridiculously low discount to grow and expand into a complex regulatory market with a renewed focus on regulatory support, product, sustainable solutions, and global markets (for us and our customers).

And there's plenty of great potential in the pipe with Salistick FDA (hopefully soon!), Eco-Flow (very soon), FOFH (must now be fully transferred to manufacturing and targeting a serious market), Loop (in manufacturing), Hormona (launching in the Autumn), potentially Lyme/Bimelix, 2 products already pretty much earmarked for NHS use in Upfront and 52N, and a major retailer building out its own brand of tests using products we supply.

And with the acquisitions we have ready access to a whole suite of new customers.

Not bad for a couple of years work.