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“There should be no acquisitions without proper due diligence and this includes when these will make a profit and how much”

I doubt they’ve taken a random punt…pretty sure they will have looked at least all of the following as part of undertaking DD…

Competitive landscape, differentiation, changes in local regulatory environment, international regulatory landscape re expansion, market growth, substitute products, price erosion, churn, sales growth, margins, investment requirements, staff attrition, key staff protection, common customer base, potential cannibalising of current revenues, repeatable vs one off revenues, key customer profiling, raft of financial considerations (efficiencies re staffing/buildings/IT systems, creditors, debtors, legal issues, pensions, balance sheet strength/risks, taxation, funding etc…)…

I think that’s a little harsh… they might not have been profitable last year but will be this, revs up 50% last FY, EBITDA loss was reduced by 2/3s, GM of 60%, modest yet sensible acquisitions and responsible cash management. Think it’s pretty clear where things are heading - new product launches might be a little slow in take up but enough segments they are operating in to offset that and still meet growth targets.

Both Chris’s have stumped up significant cash for shares (recognise they also have substantial options), and having created and sold previous businesses don’t think commercialisation is a weakness unlike most life science companies.

Personally think people underestimate how long things take and therefore becomes frustrating - negotiating and finalising contracts take a long time so things never happen as fast as investors would like but I don’t think they’ve particularly put a foot wrong post-covid. Lot of other boards I could criticise for being lifestyle companies, don’t see it here. Just imho…

The 16th Dec RNS, while stating the lab they have signed up is CLIA approved, they still need to register the LDT as having achieved CLIA approval (I would have thought).

While that would come from BIO Inc rather than Plc, they’re good with comms so given we haven’t heard yet - assume it will be part of a launch comms plan.

Re Cizzle in UK, have raised a couple of times with IR about lack of info, having to read between the lines etc… and suggested they do an IMC meeting with Q&A but falls on deaf ears.

Wouldn’t surprise me to see BIO take this globally with US partner. Given they have the Gastric test and plan to have two others later this year, certainly have larger plans akin to what you see with Guardant in the US…only question for me is how deep are their pockets and we don’t know how well they have done in securing funding, which clearly is key to speed of roll out.

Was mulling that one over Jace…

It feels like the Alamo lab would be used for product development, LFT progression etc…rather than being the CLIA lab referenced in the December RNS.

The piece on the CLIA Lab being confidential seems odd…not sure why it would be considered sensitive commercially.

“Details of this first agreement with a CAP accredited laboratory partner are confidential at this time and BIO expects to complete further contracts with other laboratory partners in due course”

The ideal, and most valuable scenario (from my perspective) as still can’t understand why Bio-Techne would RNS the evaluation study with Cizzle if it wasn’t a precursor to a potentially wider agreement…

“Bio-Techne takes a unique, platform-agnostic approach to biomarker discovery and fit-for-purpose assay development. Our readiness for clinical trial sample testing in on-site CLIA labs, combined with diagnostic kit manufacturing and international regulatory expertise, enables us to provide customizable solutions”

Also feels odd why Cizzle seem indifferent re SP / comms. I know people on here are flapping but you’ve got folk like the Langs/N Roberts who haven’t sold a bean and assume are privy to the strategy more than smaller retail investors…feels like working to a specific commercialisation model and aren’t worried about messaging / sentiment in the interim...still feel there’s a bigger involvement with Bio-Techne…

Not sure that stacks up…

Cash Jun 24 of £484k

Oct ‘24 - receipt of $300k from BIO

Burn rate typically been £300k per 6 months, but would expect that to reduce given US investment in development programme…

Can’t see a raise in near term given SP inflection points in Mar/Apr and $500k payments in coming 6 months from BIO. Might need to do so after that if developing breast cancer test subject, assuming licencing agreements in other markets take longer to sign.

Cash demands should be low given so much now being funded out of the US, and taking soundbites from the October Directors Talk interview, think that includes the LFT aswell…and “think” that’s where William Dalton fits in working alongside Prof DC.

“Just to be clear, our partnership in North America, we have an exclusive relationship with them on all product ranges, because we believe in their commercial management…”

In terms of newsflow, the same interview does suggest they have the required funding in the US (see below) but hopefully get new updates in the coming 3-4 weeks…a lot due…

“They are actually in discussions with multiple hospital groups across the USA…many new partnerships that they will make to actually supply our products into accredited laboratories…They’ve already secured funding that they need to do that”

“I expect that we will see further large trials being initiated with major hospital groups”

Follow on…What is then intriguing is how the US/UK relationship develops. The US is building a strong team but are mainly researchers / clinicians, other than BB, they lack strong business capabilities (Mary Jimenez role is part time and seems more localised in experience). In addition, they already have other business interests, advisory roles etc… which all draw on time. Given their ability to bring the right people on board you’d expect something to happen there - either on the board or a tie in with another entity that can help with commercialisation.

Then comes the LFT question - the recent RNS stating an ELISA format is effective suggests they can get the same clinical results from an LFT at clinic level. Assuming that takes c 2-3 yrs to launch (can’t imagine it takes any longer given they have all the building blocks already) that’s going to cannibalise their growing LDT business unless they take also take control of that in North America aswell. BIO aren’t going to take on the progression of the clinical test without knowing you’re protected when the LFT goes live, and you’ll want more than just distributor rights.

Given they have brought the likes of William Dalton on board as clinician for the CIZ1B test - a product that is ready for commercial launch now - I’m assuming that will be to facilitate wider CIZ1 tests i.e. breast cancer, progress the LFT, and to possibly work with partners in the US (likely Bio-Techne) who have the carrot of being able to provide the consumables (mAbs etc…) rather than BBI currently so increasingly localised in the US (beyond licence rights).

They’ve then brought in Dr Steve Henderson to seek grant funding which may suggest no broader commercial tie ups are imminent but given the resource they have brought in and the size of the market, it feels they need heavyweight partners to help them execute on the strategy (or HNWI with deep pockets or more probable…an intention to float in the next 12 months).

Lastly is the wider market - given what you’re standing up in the US, why limit yourself to that given the size of opportunity in the likes of China/India…wouldn’t make sense. Again brings the likes of Bio-Techne / ThermoFisher into the equation given existing presence in those markets - different cost point at play so can’t operate remotely from US and need local control to protect the IP.

To quote their news releases… to bring innovative solutions like our CIZ1B Lung Cancer Test and DEX-G2 Gastric Cancer Test to patients “worldwide”….

Anyway…just ramblings re the possible mid-term direction…

In my head…(others may disagree) this is what I can see news wise in the near term (the next couple of months (timescales a little subjective))…

CLIA certification - will be Cizzle BIO but UK CIZ will RNS it. Imminent / Overdue

Some insight re clinical data, expected to be 95% sensitivity, 75-85% specificity, AUC 90%+

Additional clinics signing up for studies - have mentioned being in discussions with various - expect ones like City of Hope to come onboard given BIO board members.

In theory, China should start progressing after CLIA accreditation based on AS comments last autumn.

Confirmation Alamo Biolab now up and running - most future hospital evaluations / LDT launches should then be run out of the Alamo site (March)

Confirmation of product launch (April)

Confirmation of insurer reimbursement codes - Medicare / Medicaid and price points, currently assumed $295.

Anything wider than US - no clear timescales as of yet re other markets, NHS, lateral flow test (in theory expedited given additional funds), breast cancer test etc…

Agree Hermit… all seems to be progressing well, should see newsflow shortly…trying to pinpoint exactly when isn’t worthwhile, can only look at whether things look like all okay…

Back in Oct ‘25…Allan Syms comments:

The target of screening of 14.2 million Americans a year…that’s done through 880 centres of excellence so if we’re only touching one or two of those at the moment, then you can see the scope and the breadth and the size of the opportunity to go to those other centres and offering them a confirmatory blood test is enormous.

Moffitt is fantastic, but there are other great centres across the USA. It’s a very large market. Their plans are at least initially to set up the, if you like, pathfinder labs for taking our test commercial. They are actually in discussions with multiple hospital groups across the USA.

It is envisaged that future clinical evaluations in the USA will be conducted in BIO’s planned network of CAP and CLIA accredited laboratories.

Https://www.siglasciences.com/expertise-advisory-oncology-rare-disease-cell-gene-therapy.html

Very impressive background…

Interesting… J Hinkel is also the author of the paper Dan posted below…

Interesting document…would be nice if they could be more vocal about these things!

Key things for me:

1. LDCT showing 25% of screenings warrant follow up procedures but 96% of those are false positives is a huge figure, given costs of the follow up process.

2. Re-iterated the performance of the test at 95% sensitivity, high specificity (75-85%) and an AUC of 90%+ which is comparable with low dose CT. Have now published that which is a big plus.

3. Cost difference between LDT and CT not that high (would have expected higher) but key argument is more people would do the LDT as just a quick blood draw vs going for a scan. Therefore can pick more people up earlier and therefore easier / cost effective to treat - only 5.8% of the 14.2mn in the US eligible each year take up the LDCT, so scope for massive improvement.

4. From American Cancer Society…”LDCTs also expose people to a small amount of radiation with each test. It is less than the dose from a standard CT, but it is more than the dose from a chest x-ray. Some people who are screened may end up needing further CT scans, which means more radiation exposure.” Not ideal to do every year…

5. UK NHS LDCT…. “Through the success of NHS England’s targeted lung health check programme, we have been able to detect 76% of cancers at stages 1 and 2, which turns current rates on their head”. That’s 76% blended… ciz1B test at 95% of stage 1 based on previous data…

6. If you belt and brace, so have a 90%+ LDCT and a 95% LDT you can be pretty sure the positives have lung cancer before you do any more costly / invasive intervention.

7. LFT clearly takes this a huge step further as the cost of those in clinical setting will be a lot lower and very effective initial filter prior to LDCT.

The Cizzle Bio investor deck (which was updated in Nov) mentioned they’ve “signed an agreement with a local lab to begin testing Jan ‘25”. I’m assuming that’s the Alamo Biocenter and they’ll do the testing in-house (guess that’s why in part Prof DC is spending more time in the US).

So in Nov they’re still calling out Jan as having CLIA accreditation to begin testing… and off the back of that, “should” be a lot noisier as they work to launch in April… (additional hospitals, pricing, clinical data, insurer codes etc…).

Whether it’s this week / next week or mid-Feb…not worth counting days…it’ll happen when it happens…but all still seems positive…

I think the trading update will be very positive…just depends how bullish they want to be…they aren’t inclined to over promise and don’t appear to have a near term exit so assume they’ll just keep a level approach to things…

Given new tests that have come online are hopefully going into more of a growth phase rather than initial launch, £3mn of annualised revenues from new acquisitions, US expansion which you would assume is a demand driven decision rather than a punt, and increased CDMO activity, it’s all looking very positive on the growth side.

Add a 60% GM, just grow the revenue line and they should be moving cash flow positive in H2, and currently sat on a good level of working capital to support further development.

All looks very promising…

Hi - They applied for it September/October I think - timescales I’ve seen are 4-8 weeks but assume there’s a bit of to and fro… Initially stated Nov/Dec for accreditation approval but moved to January. Whether it’s this week or next, will be a good tick to get, and in theory should lead to other labs coming onboard quicker (and in theory, China progresses off the back of LDT approval)

My understanding is that for North America (could differ in other markets as don’t have such a fragmented model) is that each clinical setting eg Moffitt Cancer Centre would have their own agreement with the agent in that market, in this case BIO. Moffitt have chosen to do a large scale evaluation study which takes time…the scale of these clinics are quite hard to grasp…$2.5bn turnover for a single cancer centre…

I would assume that might be the initial default to assess effectiveness themselves, given data readouts / reference customers don’t exist yet. Reading that article, sounds like it is to help screen post CT rather than as an initial screening test.

I am assuming once clinical data is released and CLIA is complete, a customer (hospital etc…) could sign up for the service without doing an evaluation and assume they’d just push analysis through the likes of Corepath… would assume that’s more likely in smaller clinical settings / other countries.

In the near term, thinking more clinics sign up for evaluations…would be good to start seeing these drop in RNSs to create momentum.

So do I…

Prof D Coverley been working on this for 20 years, and has large holding…husband has significant holding aswell…likewise Allan Syms…given all eggs are pretty much in one basket…can’t imagine they’d spend this amount of time on something that wasn’t commercially credible based on salaries…

Not concerned about the likelihood of success…data seen so far is good, BIO in US have committed significant funds so they must be happy and heavyweight oncology specialists there…

Only concern (for me) is them securing enough funding to make significant strides…

However, still think Bio-Techne take a stake within the next 6 months once CLIA box ticked and clinical data published.

Total salary for Allan Syms £93k

Total salary Nigel Lee £37k

Been working in this for years…could earn more as a plumber…think they’re invested in the outcome…

…oh and last figures I saw for Ciz Bio Inc was $89.6mn rev for 2027…albeit that won’t be all lung cancer as other tests come on board in time…$72mn EBIT….as with business cases whether you think it’s realistic is a different matter…. not the figures you’re mentioning…

Come on now TT…let’s go back a week… no qualms in negative comments if they’re accurate…but they’re not…

“…continual omission of specificity results can only mean one thing - they're bad, at circa 40-61% as in tests.”

40% has never been on the cards... In their previous lab results it’s in the 71% to 76% range (2017 published paper). Their commercial test, worst case in recent investor presentation in US, was 61%. If they can dual run it would be 87% (unconfirmed). 61% is still commercially valuable, would be useful though if they would provide confirmation…understand to some extent focussing on the 95/96% sensitivity / NPV which means they’d pretty much capture all positive cases early which is unprecedented. False positives would still pull more people into CT process (based on worst case 61% specificity) but still more efficient than current situation, and critically the sensitivity helps offset risk of negative CT scans (when still lung cancer +ve).

“…as other more accurate tests are developed (and don't ask me which ones!”…

You’ve got to back that up…looked at data from multiple tests, don’t see anything as accurate or commercially near term and no cost comparison as yet as they are further behind in the development cycle. Last 2-3 mentioned on here are years away…Prof DC was doing work on murine models 20+ yrs ago which is where the recent Cambridge Uni project is (as an example).

Remember the discussion on Exosome DX (EPI) - prostate cancer test achieved an NPV of 90%, PPV of 36%, sensitivity of 92%, and specificity of 30%.

AUC of 0.7.

For reference, AUC for Cizzle is >0.9. (that’s v high I.e. v good)