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There are a number of tests out there but mainly associated with clinical pathway decisions post-CT scan.

Inivata and Synovis fall into that category… improve treatment decisions basically post confirmed diagnosis from LDCT / biopsy.

The urine test one is pre-clinical so probably 10 years away and too early to determine efficacy.

Nothing I have been be to find that meets efficacy, price point, proximity to commercialisation.

You would expect something to come along in the AI space in the next 5-10 years, not based on science like Ciz but just based on patterns in blood proteins that match up with positive lung cancer diagnosis. Key for Cizzle to stay ahead of that curve is to get the LFT offering out there as assume AI approaches would need a lab test.

On the wider Ciz1B piece, while it’s possible…feels like a long way off… not heard anything from Cizzle to suggest it’s advancing in any material way - just imv.

“CIZ1 has been linked with neurological disorders including Alzheimer's disease [6] and cervical dystonia [7], and a rapidly growing range of cancers including the pediatric tumours medulloblastoma [8] and Ewing's tumour [9], and more common adult onset cancers including breast [10], lung [1], colon [11], prostate [12] and liver cancers [13], in some cases showing promise as independent prognostic [11] or diagnostic indicators [1], and in others implicated in the proliferation characteristics of cultured cancer cells”

Good read (for those who don’t subscribe)

https://www.cizzlebio.com/educational-articles/science-behind-ciz1b-early-lung-cancer-detection?ss_source=sscampaigns&ss_campaign_id=69fe0aa12e60282c8e048680&ss_email_id=6a0726fafc28db22e3b04f4a&ss_campaign_name=The+Science+Behind+CIZ1B&ss_campaign_sent_date=2026-05-15T14%3A00%3A48Z

When numerous contributors talk about selling down i don’t think it’s surprising that the wind will get knocked out of its sails a little in the short term…self fulfilling prophecy…intentional or otherwise, especially when new investors have come on board and won’t be as familiar with the company.

At this point I think it’s difficult to say what the SP will do in the coming days and weeks… the higher it goes before news the less scope for a significant climb afterwards, but then depends how effective the comms are around the launch…single RNS, not great… layered re CLIA, reimbursement, launch, media coverage…different story. Time will tell.

I think there are some givens…namely it works… can debate what the specificity will be but the product is compelling and market leading at the moment and will be commercially competitive. I think we can also be confident it launches in the very near term…ASCO in two weeks and I can’t see it launching after that personally (while noting the only firm news is the RNS that states Q2), but when you have the worlds largest oncology conference in Chicago, it’d be completely remiss to miss that date.

You would also expect The Langs to continue holding and supporting CIZ given behaviour to date and their approach to companies where they also have significant investments and have continued to hold positions through inflection points.

What we don’t know…

1. How well BIO can push it out there - private sales initially but needs embedding in healthcare programmes. Flag the latter in short order and it goes through the roof…rely on private sales for a prolonged period and it will underwhelm on sales initially, but those Bugattis and Yachts aren’t cheap so assume BB is working hard to get the partner / distribution model right.

2. Level of funding to roll out at speed in the US.

3. Royalty - economic model was based on $295 a test, so CIZ getting $30 a test… seems about right for private market…unclear yet what the price would be in a broader structured testing model and also screening model. (NIH grant approval (or otherwise) for screening study should be imminent).

4. How quickly China follows…apparently waiting on US CLIA accreditation, speed of announcing Asia progress remains to be seen.

5. UK LoI conversion to commercial agreement - would think this is imminent and you would ideally link to US launch… we have this market leading test, just launched into the US, but we’ve signed an agreement to bring it to the UK. I don’t envisage it will be quick to implement but any link to NHS and embedding in the National Cancer Plan will naturally be significant.

Whatever happens…nice to have got to the cusp of launching!

Annual results likely to be Thursday…been 30th April last two years…should give done clear insight. Hopefully CLIA in the next week or so and launch ahead of ASCO.

I don’t see that FL wants to purchase the company… they have substantial holdings in other companies like ECOB. I think it’s nothing more than seeing value and committing significantly to them.

On the plus side, i don’t see them selling on a climb… ECOB went from 4p to 25p ish and they sat tight. Assume they hold out for significant long term growth or a buy out.

Suspect we’ll still see this drop in the next couple of weeks, but hoping the next news finally sees a re-rate substantially above this range.

This was the point I was making last week… i don’t doubt the Omni comment re being available, but the operational side being ready doesn’t necessarily correlate with when you launch. I could see it being available for soft launch in the coming week or two and they pilot the process for a few weeks thereafter. (You would still expect a CLIA confirmation at that point)

That would bring May in to play for a big bang launch and ASCO sticks out like a beacon late May so a launch prior to that would make sense…certainly wouldn’t want to go public after that and miss that opportunity.

The $295 would have come from BIO last year as Hinkel was commissioned to do the economic modelling and is part of the BIO team (was published with ASCO at $295 a test in May ‘25). Might change slightly at launch but doubt it would materially so.

She should also have a good feel for it given what Sigla Sciences do.

About Sigla Sciences | Expert-Enabled Market Access Platform

Also have Ron Greeno with his Medicare/Medicaid experience so would have thought their price positioning would have been well considered.

Results

The results of the economic model demonstrate that the addition of the CIZ1B biomarker test as a secondary screening tool, either before or after LDCT in eligible, high-risk Medicare beneficiaries, could offer net savings in the range of $489M due to avoided unnecessary diagnostic procedures and the savings of identifying and treating cancers early. In a scenario where blood-based biomarker testing can also modestly expand the proportion of high-risk Medicare beneficiaries tested, from 4.6% to 5.3%, modeled savings grow to $518M. Both of these savings numbers factor in the cost of applying the CIZ1B test at a price of $295.

https://www.medrxiv.org/content/10.1101/2025.01.28.25321291v1.full-text

J Hinkel paper

If got $295 in my head… will see what I can dig out.

I can see a short term spike from the Iliad contract… provides a great headline given its expected value…but given its one CS contract in 12 months, the underlying market conditions still scream it’s a tough segment for the business at the moment. Additionally, phase 3 is more labour intensive, even at 15% EBIT on a £20mn contract value it’s not a huge inflection point for the business (other than proving they can execute large scale P3 trials). On the plus side, the other revenue streams are doing well and economic pressures over the coming year might put a spotlight back on the financial prudence of using challenge studies…then have the fact that companies still need to invest in this space, you can’t push the pause button for years…mid terms in US in November could change the landscape significantly with polls favouring the Democrats (likely to improve further if geopolitical situation doesn’t abate), which will hopefully lead to turning on of the tap and getting back to the 4-5 studies per year from FY27.

I think holding the company to the £100mn rev by FY28 is a little unfair, the environment is wildly different and think if they can get to £75mn they would have done a very good job.

Personally, can see the SP possibly spiking to 10-11p off the back of the Iliad contract (depends what the starting point is) before falling back unless further RNS’s landing, and hopefully back to 15-18p in the next 18 months imho…

Bulk of the effort has been in getting a mAb (monoclonal antibody) that can deliver the commercial test. That piece is provided by BBI, and would have needed to cover off efficacy, cold storage, transport etc…

As Cymru mentions, BioTechne have the protein machines to run multiple samples through their devices getting a result in 90mins.

Think it’s this one…sits in the OmnihealthDX labs…was a different device, from memory, think it’s this one now.

Maurice Capillary Electrophoresis Instrument | Bio-Techne

Standard Operating Protocol will detail exactly how to run the rest to get the results to at least the same level achieved in the lab in York.

After this…in theory… you should be able to repeat it in other regions (subject to their own local validations). At present, as a result, blood draw taken in clinical setting, sent to lab to run the above process.

BIO are meant to be developing the above as a lateral flow test so it can be run in a clinical setting and get an immediate result. There hasn’t been any news on that for 12 months or so - believe William Dalton in BIO leading on that, believe BIO also funding it.

There isn’t a physical test as such at this point, will be in time with the LFT. Omnihealth will operate to defined SOP using the mAbs (manufactured by BBI), reagents etc… , SOP principles documented by DC et al…

You don’t know CLIA has been approved… it appears that it is straightforward, and in theory, could be available as a test this week. That could be end of the week and RNS next week… might be earlier.

To start talking about breaches etc… is the pre-cursor to the chat going downhill again… would suggest you enjoy the ride (which for once isn’t being sold into) and see what happens over the course of the week…

IPO four years ago was the equivalent of 6p now…would be nice if we could get north of that…

Not sure it’s wise to assume we’ll get an announcement in the next day or so… think you’ve got to give it a week or two… we know it’s not far off…

Morning TT…it’s not totally clear, last thing I saw inferred 1.5% equity share in Cizzle BIO… I know 10% was mooted at one point but don’t think that was ever going to materialise with what BIO seem to be building (and funding dev costs etc…)

I think this is just the Bermondsey bounce at the moment isn’t it 😊(coupled with the Omni website update suggesting news isn’t too far away…). However, you would like to think it would rise steadily from here…not significant buying yet but equally very few sells now as launch feels nearer.

Someone mentioned a 2.5p target but that feels way too modest to me…it bounced to 4.8p three years ago, albeit on serious ramping. Personally think 6-7p is plausible if the PR is robust… then settles before going higher on additional news over the coming months.

OBD got as far as c £90mn intraday but that was quite different imv…buoyant market and came left field so got picked up by the traders…think this is a little more telegraphed re launch although would argue it’s not on the radar of most…

OBD lacked cash and network…launched with no infrastructure in place…and then had woeful sales (as a result) which suppressed any positive sentiment. At least here, the go-to-market piece is being put in place prior to launch.

Hi Moot,

I think the additional commitment gets The Lang family up to 18%.

Their own business is Fluechem Ltd.

They do have other significant holdings in the dmalk cap space and do appear to do detailed due diligence e.g. have a c 12% (from memory) share of ECOB (Eco buildings)

One other odd thing re the commercial terms…

The original agreement was for $2.4mn, made up of four payments initially $0.1m, $0.3m and then two annual payments of $1mn to the end of FY26.

The new extension equates to $0.7mn a year. You would have thought the minimum royalty payments would increase over time to align with increased rollout / market penetration.

While you would hope sales would mean this becomes superfluous, I would have expected it to increment each year.

Think it’s quite mixed…as does the market by the looks of it…

1. The royalty extension is good but you would hope it’s irrelevant given the modest level of sales it relates to. $500k a year is only 17k tests per annum…you’d like to think they’d blow that out the water given c 14mn Americans eligible for screening (you’d expect 5mn per annum) so even at 2-3% market share, it leads to decent revenue!

2. Still very protracted - CLIA might be quick (based on RNS) but Q2 could be June - if they meet that self imposed deadline - and not good form for that, so could be Spring (hopefully) but equally could be post-summer.

3. The original royalty agreement saw them receive $100k in April ‘24. An additional $300k came in October ‘24, so in the nearly 18 months since they’ve only received another $200k, I assume to preserve cash at BIO…but does suggest BIO will need further funding to meet the 2026 payment schedule - suspect it will push out again and therefore possibly leads to funding requirements at Cizzle plc this year - assume that will be met by The Lang family.

All down to how well BIO execute on launch and partnerships in place to support speed of rollout…opportunity is significant…but as to when/if it realised its potential 🤷‍♂️

My understanding with those trials eg Moffitt, is that they are going back to the York lab for testing, so non-commercial test process. (you would assume they also use the (soon to be launched) test to help with commercial test verification).

The CLIA approval - I thought - was weeks to complete, but I suspect the move from iGenomeDX to OmnihealthDX took a bit of time - personally I don’t think the “pathfinder lab” narrative was credible and assume there were issues. From what I’ve read some states (and relevant one here is NY) have different processes.

“A few states (such as New York and Washington) have state licensure programs that are exempt from CLIA requirements because their state regulations are considered equal to or more stringent than federal CLIA requirements. In these cases, you comply with the state, which then acts in place of the federal program”.

Having said all this, at the start of October Allan Syms was saying the test would be in the hands of GPs by year end…and for someone who isn’t prone to hyperbole, you’d think he knows there aren’t any curved balls that are hindering things, which would suggest they aren’t far off, but we’ve been thinking that for more than a short while!

Re the comms… I don’t think it matters how small you are as a business, you can spend some time telling your story, it’s not particularly time intensive - the unwillingness to engage shareholders and seek new interest from fresh investors is poor, I don’t think you can dress that up. Recognise they don’t need to do so, if you have royalties coming in and support from The Langs…but does show disdain for those who have helped get you to this position.