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I would expect the next RNS to be full results of the clinical test accompanied by details of how they navigate the next steps. Potentially, I could see it coming with a commercial tie up with Bio-Techne.

In terms of what that could look like (and would value the opinion of others here):

- The setting up of Cizzle Bio Inc doesn’t suggest an outright purchase.

- At present, the agreement with Corepath allows for 15% rev share and the distributor (in this case Corepath), buys the consumables, you would have assumed from Cizzle (sourced from Fair Journey / others).

- The carrot for Bio-Techne is that when your business is 80% consumables, you’d want to pick that opportunity up.

- Additionally, given their footprint and skill set, if they provide support, you’d want a wider commercial agreement beyond US, beyond lung cancer and also beyond the LDT into the LFT market.

- From Cizzle’s side, they care about getting this out quickly and progressing the other cancers / LFT test.

At a basic level, you could see a partnership agreement where Cizzle receive payments (tiered as milestones met) which secures funding for progression of the LFT and other tests. Additionally, Cizzle receive a royalty on the consumables needed by distributors as sales start to occur down the line. Would also expect Bio-Techne to commit their resources (supply chain, Go to market, Sales etc…) to help facilitate partner development as mutually beneficial to both parties to find other LDT oncology lab partners, with LFT being jointly progressed.

This could be a precursor to an outright purchase and given Bio-Technes recent history, would think an acquisition is preferable as a lot cleaner, but could see a split with some level of ring fencing of assets e.g. Conduit, and research (beyond the CIZ1 tests e.g. cancer therapies) being outside of any more significant commercial tie up.

Just thoughts on a wet Sunday morning…

I think Ciz could have dropped various RNSs in recent weeks…agreements with partners re mAbs/reagents, start of clinical trials, setting up of US registered office…all would have spiked the SP to varying degrees but probably would have drifted down again…

Does suggest he’s waiting to drop a very material news piece (just hope they don’t have to drop a basic RNS in the meantime e.g. drawdown)…they are more than aware shareholders have been very patient…

Personally think we’ll see 3-4 things land either together or in short order…

We have had various recent soundbites (below) and just from checking LinkedIn etc… we know they are still working with Bill B (and appears more closely than previous), have Vicky Zhang (Dept of Trade) and Frazer Lang liking posts etc…

From Dec ‘23 - Feb ‘24

“We are very conscious that no news has been released since the interims, but there is a lot going on.  It is just that matters have not yet progressed to a stage where announcements are appropriate”

“Yes, personally I think things are progressing very positively”

“Our announcement on working with Biotechne was important and we continue to build on those achievements”

Barclays 26th Annual Healthcare Conference today…Bio-Techne’s Kim Kelderman (CEO) and CFO talking on a webcast …all very high level, market / business direction, but a couple of things stood out for me…

1. In the process of building a GMP (Good Manufacturing Practice) Protein facility in China. Recognise the ‘China in China’ principle of buying locally, so will be separately branded and different price point to appear as local company. Will be fastest growing region in their portfolio, currently 10% of revenues. Live by end of the year.

2. Currently building out a GMP facility in the UK, also for small molecules / antibodies. Again, up and running by end of the year.

All very timely…

The other one is with regards to Exosome DX.

Looking at the Bio-Techne web content, they have a comment that they are

“the only company that can simultaneously isolate and analyze exoRNA plus cfDNA in a single step”

“Thousands of exosomes are produced from each cell - healthy or diseased – and enhancing the ability to detect biomarkers of interest , makes exosomes vastly superior to cfDNA or circulating tumor cells (CTCs). These characteristics make exosomes very useful for liquid biopsy-based diagnostics, biomarker discovery, as well as enable clinical trial and patient monitoring. In addition, our ability to selectively enrich exosomes from specific cell or tissue types and subsequently enhance specific targets is a feature unique to exosomes - impossible using cfDNA or CTCs”

I have tried (and failed) to fully understand this platform - I think it could be fundamental as to whether they partner with Cizzle vs acquire them. If there is compatibility, the scope for Bio-Techne to embed initially a lung cancer test but then subsequent tests onto their platform is huge (stating the obvious), but this bit is key to me…

I thought CIZ LDT analysed cf-DNA / mRNA. If Bio-Techne had the ability to enhance the test through use of Exosomes, in theory the accuracy of the test could be enhanced…??

Couple of science based notes…wanted to see if anyone had any thoughts…edge of my knowledge here:

One below, one to follow:

The discussions re cancer treatments rather than just diagnostics. Last year, Dawn Coverley released a paper in BMC Biology that references CIZ1B.

“Epigenetic instability caused by absence of CIZ1 drives transformation during quiescence cycles”.

“CIZ1 has been linked with a range of human cancers and in mice genetic deletion of CIZ1 manifests as hyperproliferative lymphoid lineages in females. This suggests that its role in maintenance of epigenetic stability is linked with disease”

“The reversibility of quiescence is essential for maintaining tissue homeostasis and well-studied in the contexts of tissue repair, immune response, and stem cell reactivation, while failure is implicated in tumorigenesis”

“Together, the data show that CIZ1’s protection of the epigenome guards against genome instability during quiescence cycles. This identifies loss of CIZ1 as a potentially devastating vulnerability in cells that undergo cycles of quiescence entry and exit”

My simple understanding….tumorigenesis is the development of cancers…if you can stop the deletion of CIZ1 you can stop the cancer developing / progressing…I assume this is what is being referenced in their patent applications.

May be worth listening to if you have chance…new CEO talking to investors next Weds…

https://investors.bio-techne.com/press-releases/detail/407/bio-techne-to-present-at-the-barclays-26th-annual-global

Only pattern I see TT is trader(s) buying in back end of the week (100k/300k etc…) and then selling out Tues or Weds am when an RNS fails to materialise. They’ll be back Thursday.

Not seeing any significant volume…500k is only £10k…against £9mn MCap…even a few of those add up to not very much. Just imho..,

I would think because nothing material has changed…any movement +/- 1% in those significant holdings requires a TR-1, there hasn’t been any.

Given trading volumes over the last year…anyone moving in or out would have impacted the SP…barely see £5k traded most days…it’s flatlined until material news lands.

The longer time goes on, the more significant I expect the news update to be…

- ‘ Hope to have it in the market in the very near term’ (nearly 4 months ago)

- Will only release material news (common narrative)

- Tim M…”We are very conscious that no news has been released since the interims, but there is a lot going on…further updates will be announced, coupled with investor engagement, as soon as possible” (c 3 weeks ago)

The more time passes, the greater the likelihood that news is material in my view…in the last 5 months you could have released soundbites if you so wished (info on Clinical trials, suppliers for components etc…).

They have shown an acknowledgment that there is a lack of news but still holding fire re updates suggests a greater level of sensitivity of information to me.

The longer the time gap the more likely a commercial tie-up as next update…??

April ‘23 : Bio-Techne Strategic partnership with Lunaphore

Jun ‘23: Acquisition of Lunaphore

Mar ‘23 : Bio-Techne announce investment in Wilson Wolf

April ‘23 : Complete investment in Wilson Wolf

Jun ‘22 : Bio-Techne acquire Namocell

Mar ‘21 : Bio-Techne to acquire Asuragen

Apr ‘21 : Bio-Techne complete acquisition of Asuragen

All acquisitions 21-23…announced this time of year…

Just supposition on my part… ;-)

Aptamers are part of the enablers of lft’s…(reagents)

“Patience is not simply the ability to wait - it’s how we behave while we’re waiting…”

As it stands, AS has made nothing on his share options awarded last year, and has a modest £75k (ish) salary for doing the day job. If he’s not pumping out flannel, there is no share price momentum, and he’s made it clear that isn’t his modus operandi…so the only way he (and Prof DC) gets the financial reward (and scientific breakthrough) is through substantial game changing news to drive the share price up…

If you weren’t confident, you’d pump out all sorts of teasers and sound bites - if he wanted the SP to be 2-3x higher than it is now, it’s certainly in his gift to do so - just hit proactive, Mello Monday, investormeet etc… you’d soon drive interest, especially as so under the radar with wider investors currently, but a bit of an unnecessary time commitment if you don’t need significant funds and are close to a material step change which will speak for itself…

(just my bull-ish view…)

Bio-Techne are an M&A heavy business and typically acquire a couple of businesses a year…Cizzle tick every one of their stated M&A objectives…

1. Identify fast growing and/or game changing technologies that can scale

2. Integrate acquisitions that fill product or technology gaps

3. Strengthen diagnostic and analytical capabilities that leverage our consumables portfolio

4. Support continued expansion of footprint in Europe and Asia

Number 3 just screams tie-up…80% of the Bio-Techne business is consumables (reagents, mAbs etc…), exactly what is needed in every LDT and LFT.

While I’m not necessarily assuming acquisition…if you can ensure every global LDT uses your machines and your consumables…Ciz in return get the benefit of IP protection, rigour, scale, distribution etc… If you can then seek to expand that to breast cancer and also bring on a far broader LFT play rapidly, the opportunity for Bio-Techne is vast…especially if the LFT can expand to the breast cancer market in the next 3-5 years…

Hi TT,

Just outside York…about 5 miles from the Uni…should pop in, see what they’re up to :-)

Just my ramblings…but going to beat the Bio-Techne drum again…

- Bio-Techne make 7% of revenues from China, experience in that market.

- They make 95% of their products in-house (immunoassays, antibodies etc…)

- Board have previous roles in Thermo with strong China activity (inc previous NED roles at Chinese companies)

If I was AS and, while having significant experience in China himself, if I wanted to launch into China I’d want a robust way of protecting my IP… we ship all the required reagents, mAbs etc… but all provided by our approved partner (who know how to navigate the risks in China)

Things have moved on since this release, but link below gives a feel for value…and this is at 28/42% for stage I/II (granted multi cancer test).

Personally, I suspect it’s a moot point, as think sensitivity will be high (specificity more risky) - and also wouldn’t surprise me in the slightest to see a tie up with Bio-Techne at same time as results announced.

https://investor.illumina.com/news/press-release-details/2021/Illumina-Acquires-GRAIL-to-Accelerate-Patient-Access-to-Life-Saving-Multi-Cancer-Early-Detection-Test/default.aspx

Galleri test down at 28% for stage 1 and 42% for stage 2, so anything around figures mentioned by Jace would be huge step forward.

Having said that…AS saying we have a 95% accurate test has set a narrative…(think he mentioned that as recent as Jan).

Retail investors may take issue with lower figure, Bio-Techne wouldn’t.

(but we’re all hoping for something as close to 95% as possible)

Hi VV…I had asked questions around SOP being complete, clinical trials underway, nature of those trials (ie. following the Higgins et al approach mentioned in their prospectus), and about Bill Behnke ongoing engagement. I try to only ask clarification questions based on broader relevant info in the public domain, but they never divulge anything -straight bat each time - glad they don’t tbh.

Still feel very positive, and personal view, think next news will be test results data…they seem to recognise they need to update investors but holding out to share material news - whether that is tomorrow or 6 weeks time…🤷

Recent comment from an investor relations email last week…

“Allan has passed it to me to respond to as he is currently travelling.

 

We are very conscious that no news has been released since the interims, but there is a lot going on…further updates will be announced, coupled with investor engagement, as soon as possible”

Did reply to Tim Metcalfe (Cizzle IR) on Friday…he didn’t give anything away, as you would hope, but did add, “…personally I think things are progressing very positively”

Re lack of comms - suggests (at least to me) they are confident of the destination and don’t care to spend time keeping everyone else warm and fluffy in the meantime with semi-significant news.

Seen pointless RNS’s this am from Polb, Val… Cizzle seem more like Hvo, give significant news only.

The likelihood is that the tech works, I think the variable is what the sensitivity/specificity/ppv/npv looks like.

They’ve proved it to work in a lab setting, so all should be good from a reagent / mAb viewpoint etc… and you’d also cover off variables around storage, shelf life etc… before proceeding to commercial development and testing.

They know it works on Bio-techne’s kit so just need to ensure it kicks out the right quality of data when following SOP in clinic.

If AS is saying they should have it in the market in the very near term 3+ months ago, personally think it’s derisked in terms of it working, but SOP criteria and performance are unknown variables as yet.

😂

Hi TT,

The agreement with Corepath (parking China for simplicity) gives Corepath the right to sell the Lab developed test, for which Cizzle get their 15% royalty. So, straight to the bottom line as Corepath pay for the reagents, mAbs etc…(Consumables)

For Bio-Techne, at the moment, they’d just get a small sale from a few Jess machines…but they sell loads of those to others (c 7k to date)…so not a great upside, certainly not warranting an RNS.

However, that partnership could be stickier due to Bio-Techne get the bulk (80%) of their revenues from consumables. Now, they are needed for Lab tests, but also lateral flow. They also make the LFT kits. The likes of Corepath will have nothing to do with the LFTs, they’re an oncology specialist lab, and a small player.

So, for Bio-Techne, you could just sell half a dozen Jess’s in the next 2-3 years, or you could manufacture and market the LFTs and provide all the consumables that sit behind it.

Cizzle, for their part, can potentially replicate for breast cancer and possibly others, but don’t have the funds, resource or skill set to do a lot of the multiple skills needed beyond proving the science. So a potential win-win, Bio-Techne take a say 20% stake for £x mn, giving the funds to expedite the LFT product (money comes back their way anyway), gives funding to Cizzle to develop breast cancer test so gives a further milestone opportunity down the line. Cizzle get to grow the business quicker, in a competitive space, and have the ability to make a difference sooner.

Just my thoughts…others might disagree :-)