Forum Topics PNV PNV Trading halt

Pinned straw:

Added 7 months ago

$PNV's requested a halt as it is about to announce a "significant collaboration" with beta-cell technologies in Europe.

I'm assuming this could be a drug elution product that would use Novosorb as some kind of implant/drug elution carrier to use in concert with one of Betacells drugs? Drug elution technologies were always in prospect at $PNV, but we haven't heard much about it for a while.

Despite the trading haly, I am assuming that this would have to be proven through a full clinical trial program. My assumption is that it is early stage. But I am only guessing here.

There's nothing I can see on their latest pipeline chart (below from Macquarie Conference)

b02459c16ef28ea7ef72fb64fc3d20804f99fd.png

lankypom
Added 7 months ago

Per Google AI:

*PolyNovo Limited is collaborating with Beta Cell Technologies to develop a novel Intracutaneous Ectopic Pancreas (IEP) for treating Type 1 Diabetes. This involves using PolyNovo's NovoSorb BTM, a biodegradable synthetic dermal substitute, to host pancreatic islet cells in the skin. The goal is to potentially reduce reliance on donor pancreases for islet cell transplantation in Type 1 diabetes treatment. "

The first announcement of this collaboration was way back in 2017. In the PNV half year results in February last year they announced:

"BCT has completed its first human trail (3 patient trial using NovoSorb BTM and donor islet cells) in delivering a novel IEP and early results are promising with full trial results being published late in 2024. If successful, this treatment holds significant promise for treating T1D with reduces reliance on a donor pancreas."

I'm guessing the trading halt is connected with completion of the human trial, and clarification of the next steps for commercialisation.


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mikebrisy
Added 7 months ago

@lankypom spot on. Here is the post from LinkedIn that DW has been emailing around to everyone on his list this morning

cd5ff2e6df5a8d6e6c9355f5601b67007c65fe.png

This appears to be the first proof-of-concept using BTM for what is essentially drug-elution. The extract attributes the way BTM vascularises as central to the therapy effectiveness. Therefore, from a value perspective, BTM's role should attract a higher premium than a commodity drug elution ingredient, of which there are others that have been available for a long time.

I'm not sure what this means for $PNV. On the one hand, the size of pieces are presumably very small. On the other hand, this proof of concept may open up many other therapy active agents to use BTM as the "carrier".

(Drug elution on an inert substrate that is then metabolised by the body as the drug is released is nothing new. I actually did MRI work on the dissolution of the injectibles in teh treatment of prostate and breast cancers and other conditions during my post-doc in the early 1990s, looking at a coploymer of PLA and PGA. This was a lower tech because it just dissolved, whereas it appears that BTMs integration with the tissue is an important aspect of the delivery mechanism. This means that sustituting BTM for one of the many other potentially competing carrier products might be less straightforward. But presumably, there are other materials available.)

Of course, the therapy presumably needs to go throught the full clinical development process. So it is still several years away from being commercial.

It will be interesting to understand how DW describes this when the release comes out. I wonder what the nature of the collaboration is? Is $PNV just the supplier of Novosorb, or is there something a bit more interesting here for Polynovo?

It has been a slow process over the last 8 years seeing $PNV opening up the innovation pipeline to exploit the BTM platform.

With the SP having recovered to almost $1.50, I still don't like the lack of clarity over the financial performance in the short to medium term, given moderating revenue growth. Any revenues from drug elution - if and when they arive - have to be shared with the active agent, and I'd assume the active agent would ge the lion's share, as the cost of the BTM would be a few dollars, max.

And the lack of a CEO remains a concern.

I will follow this with interest, but I don't have enough conviction to dip my toe back into this particular pond, as there are too many more compelling areas in the portfolio.

Having said that. I am going to keep this on close watch.

Disc: Not held

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mikebrisy
Added 7 months ago

Here's the release on the Type 1 Diabetes treatment.

ASX Announcement

So, in addition to what's been written before, the important imformation is that BTM would be used to delivery existing therapies. Because BTM and the existing therapy are both approved, the release makes the argument that the regulatory pathway to approval should be reduced.

Conceivably, (and this is my specuation not based on anything), they might be able to go straight to Phase III, as the primary treatment would have pre-defined efficiacy enpoints with a full dossier of clinical safety and efficacy data against which a comparison could be made.

In that case, we could be looking at a couple of years to market, with then a range of follow-on products.

Because the market is large, this could be interesting.

So I still want to know more about the commercial model. If $PNV just free-issue BTM, and the drug company carries all the development cost and risk, then presumably, $PNV doesn't get much of the upside. Seems to me that there is an opportunity for $PNV here, but then we come back to, how strong is its current cash flow to play?

Lot's of questions.

Disc: Not held

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