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Hi TT…

Just my take, but I don’t think they have changed supplier, they’ve never said who they would use (beyond early stage stuff with Fair Biologics). My assumption would be that it would be Bio-Techne given using their protein machine and they manufacture consumables.

I think there could be various reasons as to why they have used Proteogenix but I assume it’s down to the specifics of the product required - dozens of companies can produce mAbs, but assume the specifics of this are such, there are only limited options as to who could do it?

Just imho…

Not sure I get any of that TT…

Re media…they’re a small company operating in this field alongside hundreds of others… take a bigger player, Avacta…never seen the stuff they’re doing in the main stream…Tiziana re Alzheimer’s…there’s only the very odd one in the media, and from what I can tell, it’s usually difficult to understand why it’s getting coverage at that point in time.

Only covering things in a positive way…not sure I can give you that one… Allan’s demeanour is very straight, doesn’t build things up…if anything, I think his manner is skewed to the opposite…

I’m not sure there’s anything more to it than specialist mAbs needed and only certain companies can do it, and geography probably plays a factor…

I think that’s the crux of it Matt, if you hadn’t produced the commercial grade / scale mAbs for clinical testing, you’d have to go again once you’d got new commercial mAbs produced.

Hoping the testing stage is the straightforward exercise that AS stated it was…

Just some general thoughts as things settle down…

I think the placing was expected (unless they used the facility) so nothing too surprising there, the only difference I expected was that it would come off positive clinical trial news so at a higher base, when that’s clearly not the case. (Also don’t believe they’ve sold any cdt shares, and that’s a long term hold, so not seeing that as relevant to future funding needs in FY25+ (long term hold)).

AS talked through next steps on the Directors Talk interview (find it a poor vehicle to communicate as first 5 mins of 9 mins is repetition each time!), an investormeet with Q & A would be far more valuable.

Anyway, he has highlighted the following:

1) Scale up manufacture

2) Complete trials

3) Test accredited

4) Reimbursement codes with insurers

The only thing that differs, to me, was that I had 1 and 2 the wrong way round - assume you’d test it then scale up. He has stated that stage 2 is a straightforward exercise so hopefully that doesn’t take too long so don’t think we are in a wildly different place to yesterday, other than placing price!

Pieces I am unsure of are:

1) Status of relationship with Bio-Techne and why using ProteoGenix (geography, speciality etc…), and

2) How embedded Cizzle will be in the process of going to market, feels they will be more central to it than just royalty and pass through of mAbs.

3) Why not talk up US registered office / Bill Behnke role? - seems like they are still happy to keep a lid on the SP for now…

(parking anything beyond that, breast cancer, LFT etc… as assume we’ll just get left field updates on that as and when).

Just imho…

Tom, what’s your alternative, need funding, not sure how else they would do it (have inferred before their CDT investment was for the long term), so either loan facility or placing 🤷

Hi OAPK, yep, that was my understanding, but couldn’t see them actually being embedded in that process given how small Cizzle is. Maybe they get drop shipped by Proteogenix…intrigued as to why they have used them instead of Bio-Techne. Can only think it’s either product complexity or geography - easier to manage that part of the process when it’s in France rather than US??

Aside from usual discussions around placings, few things that stood out…

1. Clearly things going well as progressing to commercial launch, and confident about launching.

2. Proteogenix supply suggests not using Bio-Techne for mAbs, which would suggest no tighter commercial tie up with Bio-Techne forthcoming.

3. Could have been more bullish - could have highlighted US registered office and Bill Behnke appointment if they wanted to, seem to want to keep it low key?

4. Question re sales model - I know that purchase of mAbs etc… was in addition to royalty from the LDT providers e.g. Corepath, but didn’t envisage Cizzle being part of that process. Maybe they cover the mAbs (greater IP security) and items like reagents can be purchased through other routes? (RNS was only focussed on mAbs). Seems like they will be more embedded in the process than expected.

They both are working in the bathroom, but one’s a plumber, one’s a tiler…

They are very different things…Ciz are looking at detection only. The bbc article refers to identifying cause and best approach…more akin to what LLAI do…

Definitely complimentary WW, do seem to be at very early stages, horrible disease. Lead story on bbc below…separate story but lung cancer based (about finding the right treatment)

https://www.bbc.co.uk/news/health-68624334

Just a little more info re Bio-Techne and LDT commercial arrangements…

In 2022, Bio-Techne signed an agreement with Nonagen to be the exclusive provider of their LDT diagnostic product for bladder cancer (Nonagen is private not listed).

Just a couple of soundbites below…sound familiar? For info, Nonagen’s technology works by detecting 10 proteins associated with bladder cancer, so more linked to correlation rather than the pure science of binding to fibrinogen that you see with Cizzle. They also want to develop similar for prostate and breast cancer but looks years away based on their development pipeline.

In terms of dates, they announced the supply agreement in May 22, and had completed successful validation of the LDT by the end of that year, so 6-7 months… if Cizzle followed similar timescale that would bring us to Mar-Apr ‘24 at which point you would have clinical test results and a commercial supply agreement.

“The partnership demonstrates Bio-Techne's commitment to supporting laboratory developed tests (LDTs) to bring clinical diagnostic tools to the market”

"We look forward to working with Nonagen to develop this game-changing immunoassay in the fight against bladder cancer," said Will Geist, President of Bio-Techne's Protein Sciences division. "Nonagen's deep experience in diagnostic and testing research is complementary to Bio-Techne's extensive immunoassay expertise and world-class manufacturing capabilities, creating an ideal partnership for this important bladder cancer detection assay."

"We're excited to partner with Bio-Techne to make Oncuria available as a laboratory developed test (LDT), given their extensive biomarker discovery expertise," said Nonagen Bioscience CEO Charles Joel Rosser”

https://investors.bio-techne.com/press-releases/detail/305/bio-techne-and-nonagen-bioscience-announce-exclusive-supply

…it also fits with a comment from Will Geist on the Bio-Techne Medtech investor call yesterday, where he was bullish that anyone using their high throughput platforms also leverage their antibodies, benefitting from commercial supply agreements / scale.

Knew I shouldn’t have put figures in - ignore the price point, it was just for illustration, was focussing on the commercial relationships.

Just thinking about likely next steps, pulled together some thoughts below, appreciate opinions of others:

We know about the royalty agreement, so if for arguments sake, test in the US is $1,000, and front ended by Corepath, so they receive the funds from the insurer, 15% comes to Cizzle as a royalty.

However, after that, it becomes more debatable.

The Standard Operating Protocol will detail the process the lab needs to go through to run the test, that will include getting the device (Jess) from Bio-Techne. However, will also state you need this reagent, mAb etc… So say $100 of materials (just as an example) to run a test, this is hugely lucrative if the SOP says it has to be sourced from Bio-Techne.

Given the consumables need to be manufactured specifically, there isn’t a wider market choice on a lot of it. Previously, assumption was that Fair Biologics plus others would create the capacity.

However, given Bio-Techne make 80% of their turnover from consumables, bang in their sweet spot, and also opening protein labs in UK and China which will both be up and running by the end of the year…

For Cizzle, they have the weakness of not being able to drive volume, and the end partner labs e.g. Corepath don’t have the leverage, they’re small players aswell.

So to roll this out wider, you need logistical providers / marketing / sales support etc… which could come from Bio-Techne. Cizzle get it pushed out quicker maintaining competitive advantage doing what they set out to do at scale, and clearly in the interest of Bio-Techne to help drive growth to elevate the sale of consumables.

Could envisage an RNS, that details commercial agreement whereby Cizzle get kickback on sales / funds for future development of Breast cancer test / LFT, which Bio-Techne would ultimately benefit from, as every LFT stick needs the same mAbs / reagents.

Given activities like Cizzle Bio Inc hasn’t been RNSd, does feel like they are waiting to line up a broader story before RNSing it…

Thoughts??

Pretty much every small cap would RNS that news, but that is in part why I think it’s part of a broader, bigger narrative which they want to deliver…time will tell…

Just a couple of bits of info from listening to Will Geist today, want much that was illuminating:

1) Was bullish that anyone using their high throughput platforms also leverage their antibodies, benefitting from commercial supply agreements / scale. Does raise the question re Fair Biologics and what role they still play going forward.

2) Separate to diagnostics, he talked about their Cell Gene therapy business and role in regenerative medicine, work on replacement of damaged genes… logical opportunity re CIZ1B albeit one for down the line possibly…

Sorry, my lack of clarity - that was Bio-Techne CEO talking about their expansion in China, just to highlight they are positive in China expansion

I think things just move slowly FF re China…

Trade trip over there suggests still live.

The Bio-Techne investor call last week (see below) suggests China central to their thinking (whether Cizzle part of that, who knows).

If it was me, I’d complete everything first (partners for production, distribution, ORT complete etc…) make sure everything is robust and resilient, and then look to expand to China. Personally think this is key to the Bio-Techne relationship aswell…

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.

I’m not sure the lack of shares is relevant here…if you’re earning c£70k-£90k a year, having 13mn shares isn’t lost on you in terms of motivation…

Funding wise, baffled that they haven’t needed to drawdown (working assumption on my part is that they are already doing so or sold some CDT shares), but think the forward funding will be via a licencing/partner agreement.

…and would think it’s a given that significant shareholders would have greater visibility - at £0.7mn invested inevitable the Langs have greater awareness than us…

Just as an aside, Will Geist (protein division which covers Diagnostics) at Bio-Techne presenting at KeyBanc Life Sciences and Medtech Investor Forum today - “may” give some insight on their direction of travel re expanding diagnostics portfolio?

If I just look at the 250k/500k buys/sells… reckon he/she is £2k out of pocket…chunky buys I guess were to create some momentum, didn’t happen, sold back out and try elsewhere…

Given FY results were 27th April last year, worst case scenario is 5-6 weeks for news (although expecting sooner)