The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
Just on the proprietary piece…asking a company like Bio-Techne…US legal team of a $10bn org…can you design and manufacture this mAb for us but we want full title on it…can’t see that working out well…might be why they’ve looked elsewhere (recognise nothing with bio-techne was set in stone re mAbs, reagents)…
I think the science works… if you’ve tested it in conjunction with Bio-Techne on Jess, that has to test that you are getting the right results…a $10bn+ business isn’t going to risk reputational damage by RNSing something they can’t stand behind.
However, the question remains why are they partnering Proteogenix - we must have highlighted 20+ possible reasons, but we just need clarification.
It appears that they have now settled on the mAbs and reagents, however high level back story is important.
“…enter into the manufacturing and scale up of key antibodies and reagents”
Then this part suggests it’s an IP thing…
“…new antibodies from this development programme should extend the range and proprietary rights that the Company has for detecting the CIZ1B Biomarker”
Proprietary rights…@the legal rights of an entity to own tangible or intangible property”
Could it be that Proteogenix would manufacture but the licencing rights sit with Cizzle, whereas one of the other partners wanted to retain title?? Therefore Cizzle switched to keep greater IP protection?
Part 2…
5) Is Biotechne still involved..to what degree? Ciz is so shoddy with communication, anything could be going on.
Most people - me included - wanted a bigger tie-in with Biotechne. It hasn’t happened.
(DG) Agree, wanted them involved for scale so we were closer to an IP royalty model rather than the OBD scenario - is currently unclear re Bio-Techne.
6) China no longer in the picture it seems. I think my first post I warned of this to much derision. Why? - again NO update from BOD. Nada! Investors seem happy to go along like it’s all fine!
(DG) Personal view - couldn’t care about China at the moment. More than enough to keep them busy in US - scale of opportunity is sufficient there alone. Mail that, then worry about other markets. Would be more concerned if China did pop up given they aren’t juggling existing commitments brilliantly.
7) Not using drawdown. Not selling CDT shares. Probably mates rates for a raise. Awful - again. Trust?
(DG) I don’t think CDT shares were ever going to be sold in ideal world - he had mentioned a long while back about building an asset base of these devs. On the shares, I think the discussions on funding would have been going on for weeks, and the climb in SP in the last 2 weeks was problematic, if it had hovered around 2.2p wouldn’t have been an issue. Climbed on expectation of news - comms again!
Evening TT…I’m sure Neil will reply later, but he tends to do the night shift, so thought I’d chip in with my thoughts :-)
1) Allan Syms with “market in near future” quote was either naive, optimistic or willingly deceptive. (Any one of those is bad trait for a leader of empirical science).
(DG) I think this was an off guard comment given it was an internal call with scientists, I think very near term can be 12 months with that audience. However, if there had been better dialogue with shareholders we would be clear on timings rather than relying on inference.
2) Last year he said we were about to start clinical trials, but this was patently false. (Again, deceptive, naive or optimistic)
(DG) I think probably naive, links into your point 1) if steps are known and timescales, these issues don’t arise.
3) The Portugese reagent company - supposedly the best - is out of the picture (with no RNS) and a French company ‘suddenly’ involved. (With no RNS).
The obvious conclusion is there’s probably been problems (of nature unknown). That’s a fair assumption, no? (Again, no communication from CEO, so assume negatives)
(DG) I think there is way too much being read into this. There will have been a period of refinement of the various consumables and processes. We know it works on the protein simple platform, they know it will drive accurate results otherwise we wouldn’t have got to this stage. You aren’t getting folks to stump up £600k or getting Bio-Techne signing RNS statements without knowing there is a tick there.
That testing will also had to look at sensitivities around shelf life, cold storage etc… and among that different mAbs. Again, I think this comes down to comms, rather than anything sinister. You can’t just pull these off the shelf. If they wanted to change something that they think improves sensitivity, resilience etc… there’s a process of gene synthesis, sequencing, engineering mAbs etc… time for this could be anything from 4 weeks to 4 months. It sounds like they have now got to a final commercial solution here. Add to that the question around capability, commercial scale etc… I’d expect deck chairs to move in that process. Having said this, if they had advised the longer part of the process is finalising mAbs, establishing them for scale, rather than folding that into a generic clinical testing narrative, folks would understand it more. Equally if in the RNS they’d stated they chose Proteogenix over Bio-Techne or Fair Journey because of X and Y, that would have been acceptable - back to comms again…
I think that’s all fair comment Morpheus…
I don’t think Ciz are off track re commercialisation, they are ticking the boxes, it’s just that it’s not been clear to shareholders.
My assumption was mAbs/reagents sorted, just doing clinical tests. Next RNS would be results, SP climbs, drops off a little, then placing to generate funds to take it to commercial launch…
In practice, developing mAbs etc… that are going to be used in the test is more time consuming than expected, so progress isn’t where we thought it was - the last 48 hours is the result of that poor engagement. As mentioned yesterday, 3 mins of insight (of a 9 min Directors Talk) after 6 months of silence doesn’t cut it…
The clinical test repeat should be fairly straightforward (AS words), so hopefully move forward at pace from here.
I very much doubt the reaction from shareholders has been lost on them, suspect it’s surprised them, but no harm in some kickback at being taken for granted.
Annual results in 3-4 weeks time…suspect they’ll use that as a platform to give a more detailed forward looking statement re timelines etc… to try and recover the position from this week, but time will tell…
The annoying piece for me is the damage it does to shareholder sentiment…been damaged unnecessarily and takes time to recover…
Morning All,
I did email both Allan and Tim this morning, with detailed messages - slightly different messaging to each, but asking a raft of questions (I’ve not detailed them all here).
However, have added some of my note to Tim below, followed by his reply (did check he was okay for me to post it…)
“Good morning Tim,
I hope you are well…
Judging by the comments I have seen on various chat boards, the update from Cizzle yesterday has been very poorly received.
It’s little to do with the placing, but more the context as to where things are at with regards to development and the lack of transparency/clarity.
While some of this negativity is ill considered, some is hard to contest.
If we consider the level of update since the RNS and interims in September, all there is to go on is a soundbite in the Directors Talk interviews. Across the board, the view on those as a method of communicating is poor. There is a 9 minute interview, 6 minutes of which is context setting and wrap up, so we are effectively trying to ascertain current position from 3 mins of content, once every 6 months.
What would be really useful is a broader presentation with Q&A which covers off a range of questions, examples of which below.
***dozen questions re Proteogenix, Bio-Techne, wider developments etc…***
Response below…
“Thank you for your message and the one you have sent to Allan.
I have discussed these with Allan and you raise some helpful points. We are considering how best to address the questions and concerns being expressed, recognising the need for material information to be first released via RNS and the continuing progress being made.
Thank you for your continued support and we will endeavour to address these matters as soon as possible.”
Doesn’t give answers but they recognise the need to provide a clearer, broader investor update, so 🤞
No idea to be honest TT… most logical reason I can think of is that they don’t have the right mAb in their portfolio…from Bio-Techne website…
“…validated for specificity and reproducibility in over 25 species for more than 15 applications”…
If it doesn’t work for this requirement or doesn’t achieve the same sensitivity when compared to the product from Proteogenix??
Could still see Bio-Techne providing reagents or buying them eventually, but one for down the line I suspect…just imho…
Hi TT, will leave others to reply on some of the points, but re the mAbs/reagents, think you are reading too much into it…
I think there was an expectation that the mAbs / reagents was the easy bit and the clinical test was the time consuming part, but appears it’s the other way round. If you were doing the clinical test before finalising your product, you’d have to repeat the testing (before launch) once you’d confirmed all your final reagents / mAbs. So that makes sense - need to have a stable set of constituents before doing your final test.
I think the ambiguity comes from the part where we thought that was done (within reason) and testing was the next deliverable, and that’s the curved ball today.
In terms of the supplier, don’t see that as an issue - as mentioned earlier, I don’t think they had a clear supplier, they’d mentioned previously using Fair Journey Biologics and others (unnamed) but that can change for a multitude of reasons (capability of product, scale, cost, storage conditions etc…).
The guys they are using seem very capable…
Just taking this soundbite from their website, you get a feel for the complexity considerations…
“We collaborated with ProteoGenix for the development of monoclonal antibodies targeting a cell protein. The specificity, functionality and strong affinity of the antibodies developed convinced us to move forward with further humanization and bispecific development.
We appreciated the strong technical and scientific support of our contact which was decisive for the success of our project”
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…
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