Can Fite BioPharma Ltd (CANF)

[Spideyboy]

Apologies the delay, have been a tad busy with work and new hobby of making my own pralines! I have 5 original creations to date! Well 4 really and the 5th is a work in progress :)

On the PLX article:

While I'm happy to see a positive PLX article for once, I think there are a few confusions the lady Christina has, which just serves to confuse others. While not in a major way, I find it annoying when people write in public forums with confidence about things they are not totally clear on. Such aspects need to be corrected and then there are also some omissions which should be in there.

The issues she has are:

1. I wouldn't say 'Flush' with cash. The new raise gives them a couple more quarters which combined with additional revenues from Pfizer and Brazil + any remaining Chiesi revenue recognition, should get them to BRIGHT results and FDA Accelerated Approval. But just that current cash will clearly not last them 2 more years as she states. To me Flush would mean a good 2 years of run-way cash at a minimum. Even PLX's guidance in the 10Q is 12 months from the date of issuance, but that is assuming equal revenue per quarter which we know is never the case. So it seems she isn't really paying proper attention.

2. While she correctly attributes the key cause of death in Fabry patients as cardiovascular disease caused by coronary hyperplasia, which as in the kidneys is caused by build up of GB3 substrate in the heart cells, she attributes the value of PRX-102 and its competitors to cardiovascular disease, when the key metric being studied is the kidney function. So rather than only talking about the cardiovascular standpoint she should talk primarily about the kidney function and the significant benefit PRX-102 clinical data has shown vs commercial ERT. People can clearly see the link as per the eGFR data being provided by all past and present ERT studies, and then she can mention how that indicates benifit too for the heart cells as the Pre-Clin data shows greater uptake of PRX-102 in both heart and kidney compared to commercial ERT. But at no point in her article does she talk about the significance of the kidney eGFR data, which just seems stupid to me. That is the key endpoint of all Fabry ERT trials afterall!

3. On the half-life advantage, which she correctly notes at 80hours vs 2 for commercial ERT, she only says about how this is convenient because it means the drug can be taken once every 4 weeks rather than once every 2 weeks. This is true and nice to see, but kind of nonsensical to put the emphasis on as, the FDA and EMA approvals will be based on the 1mg/kg per 2 weeks dosing regimen, so one should talk about the advantages on that regimen vs the commercial ERT, and that she should state that on that dosing regimen there is more active enzyme over not only the same 2 week period, but also the following 2 week period whereby it means that 1 dose of 1mg/kg PRX-102 can last 4 weeks rather than the same dose of Fabrazyme lasting only 1 day but being given every 2 weeks. I think she is confusing the data on the fact that the 1mg/kg can last 4 weeks but that dose will still only be given every 2 weeks, and the fact that BRIDGE is looking at a once per 4 week regimen, but BRIDGE is a different 2mg/kg dose, so you can't compare directly with commercial ERT dosing regimens.

So seems she's a little confused herself on the meaning of all the data thus far. I don't blame her, but really you should be clear on things before you write publicly.

4. Her statement of why Shire decided not to keep going on FDA approval isn't a mystery and was clarified by 'Kesegeo' in the comments sections, who I believe is Kronberg. If she had done her DD should would have found/realised this. A little disappointing.

5. In general while she thinks it's the ghost of Shire, that is causing the issue, I highly doubt this is the case and she's stretching a bit too far based on the fact that this is a pegylated form of the agalsidase-alpha variant and that Replagal is normal agalsidase alpha. But as we know by looking at the structure, behaviour and mechanics of the alpha and beta (Fabrazyme) forms is they have the same basic efficacy, so that correlation makes no sense really. She ought to group the 2 current ERTs together on efficacy and then note the difference with PRX-102.

Then on this she states that the possibility of not approving PRX-102 based on the Replagal non approval "is possible, so it is a significant risk", is ridiculous as they are very clearly different molecules and structures which is obvious by the difference in safety, immunogenicity and clinical function benefit. So in reality they have nothing to do with each other. It's even worse than the scientific equivalent of saying coal and diamond are the same thing because they are both made purely of carbon and form a lattice structure. But clearly coal and diamond are vastly different. Coal can burn to extract energy, we can alter coal to make graphite which has a whole host of uses itself etc..., but diamonds are completely useless except for refacting light and making drill bits. Diamonds don't conduct anything, don't react with anything and you can't do anything with them and have close to zero intrinsic value. Their value is purely based on Diamond companies controlling the supply and 'mostly' women who think they're shiny and want one on their finger, and the DeBeers company inventing the value of diamonds at 1 months salary and they randomly one day increasing it to 2 months salary. But try and sell a diamond necklace you bought from DeBeers back to them and they'll laugh at you as it has no value whatsoever, except for the gold to hold the necklace together. But i digress. And anyway, the real difference between commercial ERT and PRX-102 has a chasm of difference than that example.

6. She states, "Protalix is still looking for a partner to advance this candidate [OPRX-106] through the clinic". This I feel is poor wording and comes off as if PLX has been failing to find a partner on the OPRX candidate, which is unduly negative. Not knowing the situation she should present all likely possibilities, including what I feel is the key reason which is to go it alone at least to the next clinical trial based on the Chiesi FDA approval milestone payment.

7. A small bone to pick is that she keeps writing the product as PLX-102, when it is clearly 'PRX'-102 in all press releases, but clearly confusing this with the Protalix PLX ticker code. Again small but shows the lack of paying attention.



Thus all in all, I think this lady is doing a sort-of ok job of writing an SA article but has much to be desired for in relevance and accuracy of content.

Scores:

"A-" for effort, as she took the time and didn't write anything wrong per se, except for the name of the bloody product :)

"C+" for content as again while nothing 'wrong', there is clear confusion, too many relevant omissions, inclusion of aspects that can't be validated scientifically in these shorter (up to 2 year long) current clinical trials e.g. impact on heart, and thus propagating content that confuses others which is itself abhorrent in the scientific community. We work on precision. And that she is not paying real attention to detail in almost anything. Fortunately she is semi-retired from her medical related profession.

I could of course post all this under her articles comment section, but no need to be mean, again A- for effort :)

Just for humour, feel free to see this short and funny review of diamonds being worthless. 4 mins long.

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I haven't looked yet into BWAY but will look to do that soon. And Re CANF lucky on that point as the whole market tanked except for ORMP which was up 10%. Feel free to look at that one too. I think it will take a little time, but could do wonders! And again if ORMP would be an USA based company this would already be flying. But gives more time to buy in cheaply.