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I am not surprised by the market's reaction. Whereas the RNS was helpful, in one way, as it shed a bit more light as to what the presentations would be about, it raises more questions than answers. The big question remains: how are trials progressing to-date?
Now re the first ooint / presentation in the RNS: what percentage of patients are (more) likely to benefit? Based on the patients recruited so far, is it 50% or 5%?
Furthermore, is the biomarker a direction that 4D has decided to take in order to maximise chances of trial success because data to-date haven't been satisfactory enough OR is it simply a path to explore following promising results to-date that would help make the trial even more focussed and (more likely to be) successful? Either way, it would make sense and could be a good direction for 4D to take but it'd be helpful for investors to have answers to such questions.
The text re the second presentation, was written in a way that one can tell it's positive but still hard to put in context.
In any case, there is still a lot of mist around the RNS and that was reflected in the share price. Hopefully, we'll get more clarity in the course of the next few days.
JR2
It's not that I'm "very concerned". You seem to jump to conclusions here which are simply not correct.
As part of my decision making re the right level of exposure to the company, I'm presenting my thoughts and trying, at least, to back them up - others might find it useful and I may well benefit from well-backed counter arguments.
If some short-term traders get twisted in their knickers because one's posts spoil their plans, that's their issue... :-)
The purpose of my posting is not to upset anyone but mostly to have a civil exchange of views.Otherwise, part of investing means you should be fully prepared to manage your exposure to the company as you see fit and according to one's perception of risk/returns. But, worrying about it is almost pointless.
In any case, overall, I remain cautiously optimistic even though I wonder whether we'll see a continuation of the impressive results that we've had in part A and early phase of part B.
Good luck with your investment too
Jack Russell 2
With respect you are changing your words. You said "If upcoming data was unsatisfactory, I very much doubt Oxford Finance would sign off a $30 million credit facility ..." you didn't talk about due diligence that -of course- every investor should carry out. You referred to market sensitive data.
As for your investment advice, try to offer it elsewhere. I'll pass if that's OK.
JackRussell
First, whereas the financing from OF was great news, are you saying that Oxford Finance would have had access to sensitive information on trials that hasn't been communicated to the market? I wouldn't think so and I hope not!
Second, six or even seven months is plenty of time for some kind of progress report to be issued - not talking about final results that we don't expect to be announced for 1-2 more years. I believe the report on early part B when additional recruitment had already begun (after the first 12 patients) was based on a a similar or even shorter time-frame than 7 months AND there had been about six months since the previous update.
It is this kind of update that I'm referring to which should be perfectly feasible in a time frame of 6-7 months on new or existing recruitments as of February 2021:
"...24 additional patients across five active US sites have now been treated in Part B of this ongoing study. The safety review following the first Part B cohort of 10 renal cell carcinoma (RCC) patients has been completed indicating no dose limiting toxicities. A total of 12 patients with RCC, nine patients with non-small cell lung cancer (NSCLC) and three bladder cancer patients have been enrolled in Part B to date. Recruitment will continue up to a total of 30 patients in each of these indications. ...
Target tumor reductions in Part B patients have been observed as patients reach the first scheduled restaging timepoint (nine weeks). These include the first signals of anti-tumor activity for the combination in bladder cancer, adding to the previously reported activity in RCC and NSCLC in patients in Part A."
ColdBrew
My position is similar to yours Overall, I remain bullish but increasingly sceptical as to why we have not seen a progress report on MRx0518 after six months since we read that very positive RNS following the commencement of part B, back in February. Not sure what to make of it. If I were to guess, I'd be inclined to think that further results to-date are borderline positive or just below the targets set. Were the latter explanation to be indeed the case, it may be that we are waiting for a greater number of cases to demonstrate statistical significance and/or for the target % of cases who see an improvement to be achieved. We can probably exclude the possibility that oncology results are much below target line or even a failure - we would have known by now.
Of course all this is just speculation and with a progress report on various fronts - that is well overdue in my view - we won't need to resort to guessing.
Also, re the IBS we were told about on-going negotiations with other parties / potential licensees late last year. What's the state of play there?
I notice some shift in the communications strategy from last year e.g. there are no longer timetables in the investor presentations and long periods with no meaningful updates on trials as you say for long periods. This is reflected in the share price which is - probably - much lower than where it should be. It doesn't make sense to disassociate downward SP movement to lack of updates. There are theories of "games" played by mm's or short sellers. If by games they mean market players taking short positions then the only reason that such short positions may turn out to be profitable is because of the increasing uncertainty!
Finally, my only difference with you is that, in my view, the BoD should not be too guided in its actions by SP movements as those should be taken care of through value building. Except if we are talking about director purchases but in that respect we can hardly complain!
Sangijuelas1, your earlier post seems to have been removed! Says it all. Not sure I understand your irritation but not my problem.
Sangijuelas1
under what credentials and who are you to question one's investment strategy?
Short-term trading for small price movements (as you have alleged in the past) is your prerogative. But, to show annoyance when people express a view that's contrarian to your own (day) trading objectives is a little strange. Good luck though.
ps. The news is overdue. That is why the share price is where it is.
Results are now overdue. Investors are trying to guess what motive might lie behind the presentations. If the results are good enough new investors will be drawn to the company and by all means go to conferences and explain them. For the time being though, RNSs on presentations only vaguely related to the results, appear to be tantamount to scraping the bottom of the barrel for news.
Boonco, for it to be a growth driver, as you say, it has to be positive. You can't have a growth driver that is either negative or positive.
If indeed it is a word commonly used in the pharma world- can't see how it is an appropriate use when you don't have some data in hand - then clearly we can't draw conclusions on DP's optimism.
By the way, it is the sort of catalyst I was hoping for to encourage sustained SP rises in August.
"The initial $12.5 million tranche ... extends our cash runway into Q4 2022, with multiple clinical catalysts throughout 2021 and 2022."
Using the word "catalysts" instead of say endpoints or milestones should be indicative of strong confidence in the outcome of the results. Hopefully, I'm not reading too much into it. Still, it's an interesting choice of a word.
Also rest assured that Oxford Finance would have done their due diligence. Therefore, agreeing to lend (as opposed to invest) $12.5m (in the first phase) to a non-revenue generating company may not seem as risky to them! In other words they must have their reasons.
... to see the SP at 86 was just under 12 months ago. Bit more exciting than today in fact.
Just hope history will repeat itself when it comes to early-mid August to September 2020 bull run!
Despite the various pointers indicating that 4D will be a success story (directors having a significant stake in the business, very encouraging results in oncology and IBS so far, teaming up with big sector players, positive hints at interviews, low or zero extent of shorting recently) which most people are aware and appreciate, the share price isn't agreeing and that is increasingly a concern. One can only speculate about the reasons but, in my view the most likely explanations are:
- the fact that no commercial deal for Blautix almost 10 months after results were announced in October last year.
- only vague indications of timing of progress updates on oncology trials: the expected announcement in June has been postponed for late August, September or later?
- interviews give hints of progress but such hints are nowhere near specific enough e.g. we are told of gathering strong evidence of support that LBPS work but it'd be nice to know the detail.
- late announcement of cancellation of covid-19 trial
- could it be that the data from Part B oncology trials have not been as unequivocally good as in part A? There is a (small?) chance and we can't rule out that possibility.
As I have mentioned before, will wait until the end of the summer as I think in August we may well see an upward trend. However, if there is no clear sense of direction (news or SP movement) by late August early September then it will be decision time.
What's even more encouraging than the AZ article itself which, incidentally, also mentions cancer trials(!), is that it's been highlighted by 4d.
The NASDAQ listing, in my view is a red herring. NASDAQ is only meant to be facilitating the company's growth & development path but the expectation was that 4D would maintain the momentum created by feeding it with news, significant enough, to keep the market's short-lived attention. It's more easily said than done though and in the pharma world it is only natural that progression is slow.
But, where from now? We may see, in August, waves of share price rises (like last year at the same time) in anticipation of the release of major news that are expected to be released in September. Or, is there a point when we start thinking whether there is a reason we remain so undervalued compared to peers? It is still early to say and my thinking is to wait until late August to mid-September before beginning to draw conclusions. I remain cautiously optimistic that the second half will be more a lot more packed with developments than the first: I'd just wish that such developments begin to happen in Q3 rather than Q4!
Whereas it is convenient to assume that to hedge funds are shorting the company in an opportunistic fashion or that certain investors are selling in a panic, the price has probably fallen too far down for investors not to start considering additional alternative explanations.
On one hand we have had the company telling the market that strong evidence that live biotherapeutics therapies / drugs may work is being collected across its programmes. We also have the very positive early day reports on MRx0518, announced in Febrary, referring to target tumour reductions - it was indeed impressive. On the other hand, we were expecting a further update in June that never came despite the fact that four months (Feb to Jun) should have been enough for some further data to emerge and be analysed. Now, it is very unlikely that (further) data have demonstrated futility: on the other hand have they been good enough to support the optimism and the high bar of expectations created by part A and beginning of part B (MRx0518)? Or is 4D looking for more data in order to enable clear conclusions to be drawn?
If the data were promising but not exceptionally good, the SP fall could possibly be linked to market getting increasingly unsure or even the odd leak of information. But in my view and in addition to any other factor, the SP fall is almost certainly linked to funds or traders exploiting that uncertainty.
Of course, further analysis of Blautix data looks very promising. But, we all remember how the market reacted last October. And it is exactly that kind of reaction that 4D may be trying to avoid if results are not unequivocally good in case of MRx0518 combination therapy or the other oncology trials.
It would be very helpful to have people's thoughts. I am not selling yet any part of my holding but watching closely.
An acquisition of 4d could conceivably happen soon but it is not the right time. A big pharma would wish to see further validation(s) of MRx0518 even if that means paying a much higher price. The price will not be the issue as a lot of pharmas have the funds. At the moment they are in a good place to keep an eye on the 4D business (MSD especially) and if the (very) promising developments turn into something more concrete they may well make a move. I believe that if it was to happen, more likely it would take place in 2022/23, not this year.
Many thanks indeed. If the results in part B oncology mrx0518 combination trial had been futile one would think we would have known by now. Instead, there is talk about gathering strong evidence to support the LBP case across therapies. We ll see.
Thank you for highlighting this but GSK is not acquiring the company. It's a joint-development agreement, with GSK acquiring the majority of the rights, re an oncology drug in early stage trials that has shown promising results so far with patients at an advanced stage. It seems they are still planning to start the combination trial:
https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-ties-up-with-iteos-develop-cancer-treatment-2021-06-14/
We have been aware of the Mrx 0518 potential but it's good to see that an oncology biotherapeutic drug at a broadly comparable stage (perhaps slightly advanced, if at all, in monotherapy trials but less so in combination trials) has attracted such attention and been valued at that level by a global company.
Hi Sangijuelas
Re your 12.44 "If 0518 meant that it was enabled to work in an additional 10% of patients then that would increase their annual Keytruda revenue by $1.4bn." ... what if 0518 was also shown to enhance significantly the performance on the percentage Keytruda works already? And there's a chance the monotherapy might be effective too in a small number of cases.