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I think the main near term issue is extent to which they make a noise about the launch. I don’t think the accuracy of the test is a risk given all the clinical / research personnel in BIO, would expect some level of peer review to have been done and given BB’s background you wouldn’t stump up $2mn on a whim. Add to that the number of US institutions running validations in a short timeframe and all looks positive.

However, the launch “could” involve multiple comms around clinical validation, journal publications, peer review, CLIA accreditation, launch, reimbursement codes, progression to development in clinical setting (blood draw /LFT), how CLIA now leads to China progression etc… , with investor presentations / Q&As. So scope for real momentum. Given previous form though, there is a risk it could be a bit of a damp squib and you end up with a modest spike to 5-6p rather than reaching double figures over a few weeks.

Time will tell… still think September for launch 🤞so hopefully at the start of some improved newsflow…

Thanks LB - appreciated, really useful feedback. All seems positive. He does seem a very genuine guy. Hoping Sept for launch.

Strange many of us couldn’t get on (registered a couple of times and had details of the previous event).

They’ve already raised $4mn out of a target of $10mn by May ‘26 so looks like it’s doing okay. Hopefully find out more with an investor event (assume it will be after the 12th as haven’t seen any comms other than the email LB received, but see what tomorrow brings)

Good spot… I hadn’t scrolled that far…

That’s pretty compelling…do think things are progressing well in the US, just that the comms are very poor UK side…BIO values themselves at c $75mn and they don’t own the asset…Cizzle Plc IPO’d at £22mn four years ago and now sits at £5mn four years closer to commercialisation and just prior to launch…lack of engagement is the primary driver for that imv. get some justification that you are limited by what you can say given activity is by the US licensee but should be able to give some insight in more detailed / regular updates. I can only assume they will let the data do the talking and the SP will take care of itself as others seek a tie-up, but goodwill gets lost in the interim.

Think you might have a 1-2-1 with Bill LB ;-)

Not seen the invite either (had the first one) - will chase them as admin oversight if not contacted all those previously registered.

For info…the investor page on bio seems to be updated…shows $4mn raised to date..

https://invest.cizzlebio.com/

Page 17 of the BIO prospectus suggests 1.5% (if I’m reading it right)

*All patents are owned by Cizzle Biotechnology PLC. The Company has secured an exclusive license of all intellectual property and technology from Cizzle PLC to develop and sell clinical diagnostic assays using services and products to assist in the detection of lung cancer based on the CIZ1B biomarker in North America (USA and Canada). The Company will have an option to extend the license for North America to other territories in LATAM. Access to Cizzle Biotechnology proprietary rights are secured through an escrow account. The Founder and Board of Cizzle Biotechnology will provide technical and business support as Board Members or Advisory Committee members of the Company. Additionally, Cizzle Biotechnology PLC will assign its current development and clinical trials program to the Company. In exchange for this exclusive license, the Company will remunerate Cizzle Biotechnology PLC via a 10% royalty on all sales in the USA and Canada. In addition, upon the first to occur of an Equity Financing, an Initial Public Offering or a Liquidation Event by the Company, Cizzle Biotechnology PLC shall be entitled to either (i) participate in the Equity Financing and receive shares pursuant to a defined formula (based on the current Offering, this would result in approximately 1.5% ownership on a fully-diluted basis) or (ii) a success fee of 2% upon a Liquidation Event or an Initial Public Offering (see “Capitalization” section for information as to timing of such equity issuance).

Okay…backing up the bus on my earlier comments re Bio-Techne…

2018 paid $250mn for Exosome dx…prostate cancer test, albeit still in trials…

https://zerocancer.org/stay-informed/prostate-cancer-news/bio-techne-acquire-exosome-diagnostics-inc

Today, sold to Mdxhealth for $5mn plus milestones…

https://investors.bio-techne.com/press-releases/detail/498/bio-techne-announces-exosome-diagnostics-divestiture

Seems strategic focus is on the building blocks rather than the end diagnostic product…

Doesn’t seem to be enough volume TT…only c1.5m shares…can certainly see it being apathy / fear of funding not coming through.

Looks like buys at prices of 1.38+

Could I see it going private…yup, quite possibly. I don’t see it being Cizzle BIO in the short term given limited funding - personally. More likely, could definitely see Bio-Techne taking a greater stake, just screams (to me) commercial tie up given they focus on Antibodies, proteins, ELISA and instruments…Ciz tick all those boxes, and would be modest investment for a $9bn market cap company. Given the prospectus from BIO (They mention the collaboration with Bio-Techne and aiming to refine the immunoassay for broader clinical/commercial use) and previous RNS from Cizzle talks collaboration rather than just supplier/customer relationship, and Bio-Techne have a history of dipping their toe into commercial tie ups before jumping in further, do expect something tighter commercially post CLIA approval.

The speed of roll out, in a competitive time sensitive sector, is critical and a steady as you go approach over the next 3-4 years doesn’t feel realistic given threats of AI in the next 5-10 year window…it needs progressing quicker and development of an LFT at point of care is key, and again plays to Bio-Techne.

To quote google AI…”Bio-Techne provides a variety of products and services related to lateral flow assays, including reagents, kits, and custom development services. They leverage their expertise in proteins, antibodies, and other technologies to support the development and manufacturing of lateral flow assays for diagnostic and research applications”

Hi LB,

Agree re BB being the safety blanket. Did read through the prospectus, a lot was just typical stuff as you’ve mentioned before, but a few things that were insightful:

1. Aiming to extend to LATAM. Would be logical and would prefer the BIO involvement to stop there so all Cizzle Plc eggs aren’t in one basket. If something can emerge with the NHS, hopefully iCCAMT kicks forward after CLIA accreditation but still leaves scope for other partners in India and Europe (possible also scope for wider Asia).

2. The funding deadline seems to be Apr 26 so lots of time to try and meet that target.

3. As you mentioned previously the Bank of BB had previously provided $1.86mn to get things moving and that was fully paid back by 7th Jan this year so if he needed to provide additional capital in the near term you would think that’s available again.

4. They have 6 months cash runway from Mar ‘25 so assume the recent push for investors is partially linked to that.

5. They mention the collaboration with Bio-Techne and aiming to refine the immunoassay for broader clinical/commercial use - building on the Bio-Techne piece feels key for any accelerated roll out.

There are a couple of grey areas (for me):

1. “Investing in further technology and product development”. The technology piece in market makes sense, the product development piece is a curious one given there’d need to be a separate commercial arrangement should other markets want to benefit from the development activity at BIO.

2. The SAFE piece on page 122 “Proceeds from Issuance of Simple Agreement for Future Equity” - not sure if anyone is familiar with this? At $2.5mn my assumption is that this was funding already secured but is sat on the balance sheet under this vehicle until it gets converted to shares after the fund raise?

I find the general lack of comms concerning - a Directors Talk interview 1-2 times a year is poor especially given lack of Q&A opportunity. It really isn’t that difficult to do an investormeet every 6 months to keep investors in the loop…

With regards to the July 31st payment…you would have thought that given the modest agreement in Cayman, you wouldn’t have signed it and committed to the early royalty payment if cash flow was likely to be an issue.

Conversely, the heavy comms from BIO seeking investors in the last 2-3 weeks seems odd, coupled with the narrative in the Annual Report it does create doubts…

“These scenarios show that the Group is reliant upon the timely receipt of the first $1m (approx. £570,000) of Guaranteed Minimum Royalty Payments (GMP) from Cizzle Bio Inc (“Bio”), in respect of the Group’s Royalty Agreement covering North America and The Caribbean. The receipt of two GMP instalments of $250k (approx. £190k) in July and September 2025 is dependent on Bio signing a deal with a Caribbean hospital (recently signed) and would represent an advance of the first $1m with the balance of a further receipt of GMP of $500k (approx. £380k) is expected to be received in January 2026.The receipt of these royalties is not dependent upon Bio’s appointed Research Laboratory, iGenomeDX, achieving a CLIA accreditation. However, there remains uncertainty if Bio will be able to make these payments as it is dependent on raising further funds. Should these royalty payments be delayed or not materialise, then the company may be required to raise additional funding to continue to meet its obligations.”

I guess we’ll know one way or the other in the coming days…

Seems odd at 15 mins notice…given been pushing the event for the last 2-3 weeks. Could potentially see it as Cizzle Plc only had late visibility of the presentation and had concerns re financial regulator issues if things mentioned by US Cizzle that haven’t been published / signed off in UK?

They could do to provide clarity to avoid conjecture though!

CLIA accreditation is needed pre-launch. This is the iGenomeDX piece and then insurer codes etc… falls off the back of this.

This should be imminent, but lack of shareholder updates leaves you guessing. (Detail at the bottom from the Annual report)

Other activities would be concurrent to commercial roll out, and include:

- Moffitt Hospital evaluation (will be c 3 years to complete). Would expect others.

- Research project on screening

- Blood draw (Tasso piece) - this is half way house to LFT. Blood taken at home, but still tested in lab.

- LFT

“The accreditation process involved an evaluation of a laboratory’s operations, including its testing procedures, quality control, personnel qualifications, and compliance with regulatory requirements.”

“The successful completion of the operational and quality systems programme is necessary for launching a cost-effective and scalable version of the CIZ1B biomarker assay with rigorous quality control requirements to meet expected reproducibility and sensitivity. This will demonstrate the test is commercially scalable and can be rolled out as a global solution”

The Cizzle BIO investor call on the 15th… I’m still nervous about the capital needed to progress at speed and any insight as to skin in the game from the BIO board, whether equity in lieu of salary sacrifice, investing in the company etc… not sure we’ll get info given Ltd Co status but hoping we’ll get some new insight on that call…

All seems logical to me as a further step…

Key piece…”we aim to build the evidence needed to advance a clinically validated, low-cost blood test to the front lines of lung cancer screening”…Screening, step before diagnostics.

Clinical studies have been based on Stage I/II lung cancer, this is looking earlier…

To identify whether it can pick up pre-stage 1 I assume would be similar to gene markers in other cancers, can you identify whether someone is likely to go on to develop lung cancer. The repository I assume is access to pre-cancerous blood samples, but have the mapping to show which ones progressed to cancer. Validating it’s ability to predict onset is different to what has been achieved so far and doesn’t impact commercial launch.

Also compelling that growing their collaborations and therefore exposure in the US…Florida Institute for Human and Machine Cognition (IHMC) and the Southwest Research Institute (SwRI).

Shows Dr Steve Henderson role of seeking grant funding to expand learning…so making use of available grant funding streams…

Interesting piece is the blurred lines between Cizzle UK and Cizzle BIO…way beyond a licencing agreement as the US driving the development path now (in conjunction with Prof DC one would assume…), still think it could swallow up UK Cizzle if they have deep enough pockets…next week will be interesting…

A bit too early for me yet LB…I need to understand more about them and I’m not 100% sure that will be forthcoming on the 15th given private company status…

Hoping they give some insight on the following:

1. What level of investment is needed to support roadmap delivery over the next 12 months? How much is incremental to current company funds? Slightly nervous about level of working capital to facilitate desired rollout…

2. How is the board being remunerated? Salary vs part equity?

3. Have any board members invested in Cizzle Bio?

Raft of other Q’s around global licence aspirations, relationship with Bio-Techne etc… but financing (as with most start ups) is my main focus/concern at the moment…

Just my personal view… The $500mn was based on savings per annum through improved screening not spend on the Ciz diagnostic test.

It’s a really hard one to determine, and in my view, they’ll be acquired long before the big numbers are realised, but as a simple calc based on say yr 3 as roll out builds up…

There are c 15mn Americans eligible for annual screening…most don’t take it up for various reasons…

Assumption is that 6-7% would do so…

That gives an approx 1mn tests per annum…

At $300 a test, Cizzle UK would see 10% - assume net of taxes so maybe $25 a test.

That is a licencing agreement, so revenue flows straight through to the bottom line…

You wouldn’t have full country penetration, so assume you could get to 30% of the eligible audience by year 3.

1mn audience x 30% reach x $25 = $7.5mn in fees per annum. So on a PE of c 10-15, that’s be a $100mn valuation…just from the US…and just from screening.

Clearly huge potential beyond that from other markets given US is only 5% of world population - and also increases as you extend your addressable market and can get your take up beyond 6% which you should be able to if it’s a simple blood draw rather than having to take 1/2 day to travel and have a CT scan.

This is just screening though… if you look at Moffitt, it’s more embedded than that.

You’ve got 1/4mn people in the US with lung cancer…so then have ongoing testing as they go through treatment plans to see if they still have it and then ongoing tests while in remission.

I could certainly see it being worth £250mn+ in the next 3 years or so, assuming nothing comes in left field to usurp it…also doesn’t factor in LFT market. However, still think they’ll be acquired before then…primary driver was to help improve lung cancer survival rates and if you can throw capital at an approved test, they’re going to have greater success than having a modest roll out limited by financial constraints - ASCO certainly helps in that respect.

Not sure if that helps?

Found it

https://meetings.asco.org/abstracts-presentations/search?q=Hinkel&filters=%7B%22contentTypeGroupLabel%22:%5B%7B%22key%22:%22Abstracts%20%26%20Presentations%22%7D%5D%7D

They use a peer review process, so while it can’t be considered 100% endorsed, it does give credence to Hinkel’s paper. Also, given they have an acceptance rate of c 30-40%, does suggest the assumptions on sensitivity, cost and uptake rate are endorsed.

Additionally…the research may require approval by an ethics committee or institutional review board if necessary, and informed consent must be obtained. We don’t know if this was necessary in this case.

For some reason can’t find the abstract on the ASCO website.

Good timing though ahead of ASCO starting today. Do think BIO are going about this the right way…

ASCO also sponsored by Conquer Cancer, a body that Bill B is on the board of.

https://www.conquer.org/news/conquer-cancer-announces-new-board-members-and-board-appointments