PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Spideyboy]

Thanks for the concern, but I believe all is fine in Shanghai at least.

Shanghai has seen 300 virus cases out of a 'low' seasonal 10 million population (low population as outside of Chinese New Year, the largest annual human migration on the planet, Shanghai normally has a population of 25 million). So doing the maths that's currently a 0.003% infection, and Shanghai has had only 1 death which was a few weeks ago. Additionally (if we choose to believe the Chinese numbers) the numbers of new infections across the country are going down considerably. From a selfish standpoint 90% of deaths are in the elderly population and/or with pre-existing medial issues. As far as I know I'm not over 80 years of age and thus even on the minuscule chance that I would get it in Shanghai, I would end up with a nasty flu but that's most likely it. However this would be very different if I were near Hubei province, I cannot imagine the life for the people there right now and my thoughts go out to them. I could go further on this, but I have clearly digressed.

Just listened to the presentation too.

1st: True the key interesting slide was the milestone one and indeed you are correct that I was initially somewhat surprised that the Bridge data is slated for late March/early April, however this may simply be that, as mentioned in the presentation slide this is for full "Final Results". One might keep in mind that while there is 1 primary endpoint there are 11 secondary endpoints to the study (and technically the eGFR slope is itself a secondary endpoint of the Bridge study).
https://clinicaltrials.gov/ct2/show/NCT03018730?term=prx-102&draw=2&rank=1

From my perspective this would mean that all results across all 12 endpoints will be available end March/early April. However that does not preclude earlier Full-sample Top-Line results of the eGFR slope change as I would feel that would be, in accordance with safety data, the top data-point to analyse. Thus I would still feel that the eGFR slope data should be out sooner than for the full "Final Results". Again the last data point should have been taken on 17th Dec 2019, so after data cleaning, they would have had the data for at least 1-1.5 months now which is when I would expect some kind of top-line information, if PLX chooses to provide top-line. They may of course give the whole data package at once on Final Results.

Either way even if there is a slight delay, I'm not concerned, and neither does it seem is the market. I am again not wildly concerned about the financials, as I believe they are likely to do a raise after Bridge results, whether Top-Line or Full. Which hopefully would be at a significantly higher share-price than now.

2nd: On the Pipeline slide. I find it positive, interesting and positively interesting that while OPRX-106 is continues to be rightly delineated as the 2nd product in their sights, now OPRX-106 has been granted a formal name "Tulinercept". While small, this would mean that the USAN Council has approved this name, and that PLX is not totally leaving other programs by the way-side and still executing on non-clinical aspects at the moment for OPRX-106/Tulinercept.

In following with this, we can also see that PRX-110 for Cystic Fibrosis is back to showing itself as relevant to the company when on a prior earnings call I remember the company speaking very little about it. I think this looks like an excellent candidate too, so hope they are reviving it as it were.

And then on just a very insignificant note, interesting to see one of the pre-clin candidates is for gout. This could be a very interesting market, as gout is not uncommon, and there is no really effective treatment for it. Treatments mainly deal with the symptoms of pain, not the underlying cause, and some that do, go about it in a not so natural way by stopping to production of uric acid. However uric acid is a normal bi-product of protein metabolism of meat we eat. It would be far better to allow the body to continue its normal function but then assist it with clearing out the uric acid which hasn't been cleared out properly.

While clearly not life-threatening Gout can be chronic in the sense that someone who suffers from it can have a flare-up at anytime, I have a friend with it and it does impact his life considerably as in not being able to walk or sleep well for days to a week or so at a time due to the swelling in the foot and pain. So will be keen to see how this one goes. Gout is caused buy excess uric acid in the blood stream that isn't cleared properly by the kidneys so collects and crystalises in clumps in lower extremities of the body,hence the foot being the key location. My friend has tried all the key treatment options and found them not to very efficacious and some quite costly and now regularly drinks concentrated cherry extract as he feels this delays the onset of new flare-ups. I'm not convinced as there is little evidence to support this but if it makes him feel better that's fine, and it doesn't cost much. But suffice to say it still doesn't meet his needs. If PLX is developing a long half-life enzyme that breaks down uric acid, this could be a good manageable treatment. With something like a once a month injection.

I obviously have no understanding of the enzyme construct that PLX is going for, but as gout needs time usually between flare-ups and flare-ups happening at anytime, then one might even envisage buying a pack of 3 injections. Keeping them in the fridge and then injecting once a month, similar but at a considerably lower frequency than is done with insulin for diabetes.

Gout apparently affects about 1-2% of the western population. So if we go with the Populations of Europe and USA at a total of about 1 billion, then we have a market of 20 million people. My friend is of Sri Lankan descent working in London, so we can safely assume on the global level we have at least 30 million people with this. With that big a target population and with even a once a month injection and about 20% penetration (if it's a good product) the price of the product would not need to be too high to garner substantial revenues.

But this is all just conjecture at the point. But always interesting. The focus is clearly PRX-102 and then OPRX-106, and rightly so.

Looking forward to seeing this weeks other 4 presentations!