|Meanwhile Sylviane Muller and her team are pushing on in the CNRS labs. An abstract regarding her research into Lupus Nephritis was published online yesterday - title:-
"Autoantibodies against Modified Histone Peptides in SLE Patients Are Associated with Disease Activity and Lupus Nephritis"
|Waterloo01, the trials just have to replicate the results of Phase2 but on a larger scale...|
|What they hope is that the FDA will give them approval based on the 200 trial with the 2nd 200 as a confirmatory one. The results would have to be stonking for the FDA to agree, but that's what they hope.
However if they have to do the 2nd 200 to get approval, if the current trial shows good results, raising the funds at this point to run the 2nd trial will be fairly easy and from a much higher base share price IMO|
|My view re the second phase 3 trial is that it will have to be undertaken but that the company will be authorised to start distribution of Lupuzor for the treatment of Lupus before that trial takes place.The costs of running the second trial would be met by income and/or placing shares at a much higher price than today's.|
|So our money is safer here than in Deutchebank?|
|At the moment the most likely outcome is surely that they'll get decent results, then raise more cash to complete the second half of the spa?|
|After 3 monthly injections, 62% of participants in the double-blinded phase 2 tests saw a significant reduction in their SLE symptoms. The results were statistically significant against placebo (0.015). This is the best ever therapeutic response to Lupus from any drug - and by a long way.This is why the FDA awarded the phase 3 tests an SPA: it is a confirmatory trial over what were seen as pretty conclusive results in phase 2.All 125 participants in phase 2 completed the 3 month assessment. I would expect all 200 participants in the phase 3 to finish the one year assessment. Why? Because these poor people for once actually have a treatment available that actually diminishes rather than alleviates the symptoms.One can sit in the dudgeon of a typical conservative investor mindset if you want, but the upside here is astonishingly good whilst the downside risk seems negligible to nil.For me the only risk is that the trial will be mismanaged in some way - but given we are now close to full enrolment and Zimmer has put his hand deep into his own pocket, I am more than happy to start counting some very large chickens from the eggs being incubated here.|
|It's hard to see much residual value if Lupuzor were a write off. IMM would be left with a few early stage programmes and no cash, so any new investor would take substantially all of the company.
I think it's important to consider scenarios in the middle, though. For example, what if the P3 just misses, in a way that suggests it would have succeeded with a bigger sample? Or it fails but the data imply new trials on a subset of patients would succeed? In that case there might be some residual value.|
|Below is an old article which explains quite well the 'me too B cell treatment cul-de-sac'
|Well said longshanks.
In short, immunosuppressants either mean low (or no) efficacy or high side effects (and often both).
For those who have not seen it, it is well worth watching this video:
At 24 minutes Prof Muller explains that Lupuzor is not an immunospressant. It is an immunomodulator. It doesn't affect the totality of the immune system. Cells respond normally to an infection. Mice have been infected after taking Lupuzor and they recover and still produce good antibodies.
i.e. There is a new method of action that does not follow the path of all those failed immunosuppressants targeting the B Cells [which is not Lupuzor's target].|
|Re Benlysta and the "magic bullet" cure for Lupus that has been so elusive.Most if not all other competing therapies that have been evaluated for the treatment of Lupus have emulated or mimicked the mechanisms employed by Benlysta. Lupus has long been seen the consequence of an "overactive" immune system so potential therapies have worked to stop the immune system being so active. Naturally such an approach has some seriously negative side-effects.Lupuzor uses a different mechanism: it doesn't suppress the immune system - it refocuses it on real threats to the body. This novel approach possibly makes it a higher risk but equally it could be argued that the impressive phase 2 results (p=0.015) and the FDA giving the drug an SPA and associated easy crossing line reduces the risk considerably.|
|Hi Brucie5. There are a number of possible strategies. Buy and hold what one can afford to lose (as per all aim stocks) being the simplest.
My preferred strategy is to hope that there is a rise between now and when the trial results are expected. Anyone who buys now can cash in 50% at 75p and have a free carry on the rest with the massive potential upside that we can all see.
The risks with such a strategy are two fold. 1) The share price does not rise between now and trial results; and 2) there is early termination of the trial.
Although I expect 1) to not be a problem (the question for me is more likely to be when rather than if the share price rises; and completion of patient recruitment being an inflection point starting the clock ticking), it is not terminal if the share price does not rise that much. There is a simple strategy to deal with this. One can always reduce one's exposure to avoid the binary bet.
2) does carry high risk, but the odds (given that the trial has continued to date and given previous safety results) are firmly in IMM's favour.|
|It's a biotech and it's the nature of the beast. I certainly wouldn't 'over' invest but it's not often you get a tiddler in phase 3, with potential blockbuster drug at this sort of market cap, but your investment logic seems sensible.
Edit: As a gamble the odds are rather attractive, depending on what you figure is the upside, but 10:1 + is possible/likely IF it passes the first of the phase 3 trials.|
|So possibly one to play pragmatically..? It's surely more likely to go up in the approach to December 2017, assuming it doesn't blow out before then. I would imagine there's a decent arbitrage opportunity for some. But perhaps more of a gamble than an investment in the conventional sense, since so binary. Safest place to buy would of course be after results, by which time it will either be several £ or not very much.
Hmm. I will think on it.|
|Brucie, posters better versed than me might answer, but essentially yes. It's a two way bet. If it fails, will be limited (but some) value. Down side 90% v upside??
As to Benelysta lots being written about it (a quick google will show) and yes is a complex area of medicine, with huge variation in how it effects patients which is one reason there is such huge unmet need.|
|This is a very exciting situation, though haven't looked in for a while. Basically, there a 14 month window for this to succeed, and become many times its current value, or fail... which is my concern here.
SK has done sums to show what success could look like over that time scale. But what might failure look like, besides failure of Lupuzor to meet stage 3 requirements..? Would that be curtains for the company? What might be the vestigial value?
The CSO clearly seems willing to put his money where his mouth is. Not a small token of confidence. But I'm still trying to work out if this is entirely a binary bet on one drug, where you have to happy to lose the lot, more quickly than one could exit the company!
The fact that Benelysta is the only drug in the ring, may also be a red flag to the extent that finding that magic bullet is not going to be straightforward, or someone would have found it by now. To state the obvious, blockbusters are not easy to come by, and hence the diffidence of the market to value for success.|
|Maybe they needed extra cash due to Brexit and the effect on sterling: most of the costs for the P3 trial are ex UK and I am guessing all or most of the company's cash is held in Sterling.|
|PDT fair comment but begs the question why not say that in the RNS if that is the case. It doesnt make sense not to. Nor does this fit with the presentation at Mello earlier this year|
|They did not need this additional £1m raise. They have already stated they have enough funds to complete the Lupuzor trial and it seems to be running to plan based on recent announcements.
I wonder if it will go towards progressing the other potential uses for P140.
All good news and it is interesting times.|
|I suspect all the cash will be quickly eaten by the ongoing trials plus regulatory work in the background. They do run a fairly frugal ship, as as mentioned above, they do have other, irons in the fire. Zimmer buying £370k worth is noteworthy.|
|Why do they need more working capital?
edit. Why do they need more working capital so soon?|
|Waterloo01, agreed and with Zimmer owning over 20% it does make it far harder for a potential purchaser to get either the company or Lupozor at a low price.On the other hand, having an offer accepted or not will be heavily influenced by Zimmer's opinion.Irrespective though, his decision to make large purchases does show a lot of confidence. Director buying inevitably generates a significant amount of interest in the media and reporting this news late on a Friday gives investors a window of opportunity to research. Monday will be an interesting day observing share trading volumes.Glad I'm already invested here. GLA LTH's.|
|When I first saw the RNS I thought 'oh oh placing' but then I read the details (and since the more recent RNS this eve) and ..excellent. Gives IMM some protection from any low ball approaches). All down to the trials now. I note all bar one centre are now all recruiting, so hopefully they will hit their end 16 deadline. It will feel like a long wait till results in 12 months, so hopefully they will have some other announcements (such as further indications) and the rest of the portfolio, which is all rather quite in public anyway.|
|Further RNS out.
Zimmer, our Chief Scientific Officer has just bought 1,057,143 more shares (£370k). That is a substantial purchase. There are no certainties in life and I have seen directors get their purchases wrong - the trial is also double blinded - however a purchase of this size shows great personal confidence from him at this stage of the clinical trial in both Lupuzor and Immupharma.
They have raised £1m rather than £0.8m in the additional placing.|