I'm not sure I agree with you on some of this.
- For the Bright study, they didn't need to announce the extension really as this was always part of the plan mentioned as part of almost any piece of information the company has provided recently on all the Balance, Bright and Bridge studies. Perhaps they could have made a PR about the fact that the patients were being followed for a longer time and when those might have started, but realistically at this juncture that's not terribly valuable or material information vis the stock proce.
- On the EAP, I agree this would warrant communication on, but again except for our speculative understanding that this should relate to confidence of regulators in the product, it is not likely to translate into that much in terms of revenue or as data points for regulatory approval as these by definition are patients that don't meet the clinical trial criteria. So again not really valuable or material information.
I do agree that the lack of follow-up on PRX-110 is not ideal, but I can think of reasons why. First of all, while the Phase IIa data did come back positive. Protalix has mentioned previously that the next step would be to conduct a larger phase II. This means vis-a-vis time and money, they have to run a larger Phase II and then a Phase III. On the other hand, the data from OPRX-106 came back extremely good and with great advantage not only on clinical benefit with great efficacy and no systemic absorbtion or side effects, and also uniquely available via oral administration. Also remember that while the OPRX Phase II trial was only looking at Ulcerative Colitis, following from the data, they expanded the scope of the product to also cover Crohn's Disease and thus the whole of IBD. Therefore it would make sense if they can to go for a Phase III for IBD. Not only would this be faster time to market but, IBD represents a 8.5 billion dollar market vs cystic fibrosis, in about the 3-4 billion dollar range?.
Thus with the limited resources that Protalix has, I would feel it best to pivot to OPRX, go for a product with more than double the market value, and with great advantage over current treatments and faster to market hopefully by a few years.
Thus I feel on PRX-110 they are probably running a trimmed down team to keep negotiation going with potential partners and once something like that is locked in, then they can have a better look at the resources to allocate to PRX-110 vs OPRX and the long-term benefits.
Regards the list you made to increase share price
1.another partnership (yes this could increase share price as we would be getting this on a new asset, which would show confidence in 110 of 106. However I don't think this will be a serious increase in share price as the Chiesi deals commit over 1 billion dollars and those have done nothing for the share price)
2.obtaining significant milestones from Chiesi (again, I don't think this will really make a serious difference, as Protalix already has the money to get them past approval for 102, so adding in a bit of extra cash isn't really a deal-breaker. Also even with a new deal, this would in the short term amount to only about 20-25 million upfront, which isn't hugh money with Protalix's cash burn at about 40 million per year.)
3.suspension of the Bright study for the apparent advantage (This I feel would drive the price up significantly, but I highly doubt this will happen. Data readouts are in less than 12 months from now and there are already commercial ERTs on the market so the FDA will most likely wait till full data and even Protalix might want the full data possible to maximise the ability to convince physicians. The higher the N=XX value the better to convince)
4.EMA and FDA clearance (This is the singular event that I believe will make the price rise significantly and very significantly at that, then the next rise being on revenues to prove the market may be in line to use 102 as a gold standard hopefully)
5.buyout (This would clearly raise the price, but I think unlikely, unnecessary right now, and I personal would not be happy with this.
Unlikely as I mentioned, they are currently valued at 70 million. If someone wanted to buy them out, they could just earmark something ridiculously low at 300 million buyout, which would be a huge % premium on the value over the current SP and for that matter the SP over the last 2 years. So if they wanted to sell out, this would be easy. For example, as a defensive measure, Sanofi could easily buy them out. I also say unnecessary as Protalix doesn't need to sell-out as they have a product about 1 year from data read out that could become the gold standard and represent billions in revenue and for which they have extensive milestone payments lined up and already the money to get them to approval. And personally I would not like this to happen as I'm not looking for a 300% gain on my investment, I'm looking at the thousands of percentage gain, that could easily be achieved with minimal revenues. With the current market cap at 70 million,
5000% increase = M/C of 3.5 billion.
As we know Amicus, which is only treating about maximum 20% (and maximum theoretical of 30-35%) of the Fabry market and with revenues of about 80 million has a M/C of about 3 billion.
102 would be relevant to virtually 100% of patients and with superior safety and activity profile to current key ERT products should definitely be bringing in hundreds of millions in revenues. Thus I am hoping for more of a Protalix 10,000% increase = 7 billion M/C at least!
Also that would just be on the single 102 asset, then we need to also think about the added value from 106 and then add more to the M/C. Technically if we get good 102 data and then approval I don't see why Protalix would need to dilute again.Adding new assets will not I believe have the same effects on share price increase compared to first key product approval (I'm not counting taliglucerase in here) as M/C do curve and plateau, but it should add very nice % increase nonetheless whether OPRX might get approval for either UC or Crohn's or the totality of IBD). So I am definitely long in this one :)
Then add on the potential for 110. Not to mention the still unnannounced other pipeline candidates.
AI
