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To the bulletin board:
Please see comment by covidopportunist 6-Nov-21 on NCYT board 07:53
https://www.lse.co.uk/profiles/covidopportunist/ ... in particular the last paragraph.
Whereas it is a good omen that the circus has arrived in town, people should be wary of arbitrary price ranges or targets.
Do they come from sources that know the company better than investors who have been consistently with the company for months or years? Do they come from sources that used to that NCYT would reach £54?
4D has tremendous potential but we are not waiting to be told that by the circus that has just arrived in town.
Dave
"... Don't make assumptions if you are unsure."
On the contrary, I specifically avoid to make assertions and present them as universal facts on the basis of no specific or flimsy information. The latter is happening a lot recently.
You'd recall the other day someone called Boonco wrote a questionable post (from a motives perspective) claiming that Mrx 0518 Keytruda trials were going very well on the basis of a rather flimsy link to other announcements on (unspecified) pivotal trials, trials at an earlier stage. That was in response to my post saying that since feedback on 0518 trials has been being postponed twice we need to know why and that we may have had to refocus the trial on a group that is likely to respond better. We know for a fact that the company is looking at patients with a biomarker who are likely to respond more than others - we just don't know the reason.
Then you claimed that it's obvious 0518 Keytruda trial wasn't going well (how do you know?) and you called Boonco names. Now you are sure that we'll have 5 pieces of news by the end of the year. I do question the credibility of the Twitter post, by the way, given that the official 4D announcement talks about Q1 2021!
In any case, very pleased to see today's rise. Just hope there is an underlying basis for this.
Porky, not quite.
The news you list is expected any time between now and in the course of next FIVE months (i.e. end of Q1 2022) according the the company. So not sure where you get the three weeks or end of the year from.
On average though, we can expect one piece of news per month till March 2021- conservative case. But it might also be one piece of news per every two to three weeks until end of the year and the other two in 2022.
Also, setting £1 as a target doesn't make sense: barring a very negative scenario, there should be hardly any downside from here! The lack of proper communications from 4D for 9 months or so has been one of the factors taking its on the price.
On the other hand, firmly positive news in even one of those projects should make the £1 look a conservative estimate - good news on Part B in particular will make it a very conservative one.
Sangi, be careful. Your 11:02 post is getting dangerously close to market abuse.
1. it's an UNFOUNDED claim re company not having funds and having to resort to dilution if they opted to run phase III Blautix - what's the evidence to support it?
2. Second, it is most likely FALSE:
Take a look at the following links:
(i) https://www.raps.org/news-and-articles/news-articles/2018/9/phase-3-trial-costs-estimated-at-19m-study-finds
[NB. 19m ref is to USD] this is a general article and refers to "a central cluster of trials with estimated costs of $12.2 million to $33.1 million," so Oxford Finance could well be able to cover it!
and then in conjunction with 4D's communications:
(ii) https://ir.design-portfolio.co.uk/viewer/18/18597 they refer to being funded until end of Q4 2022 and that's without the conditional extra tranches...
3. Third: there are many types of deals a small / medium company can do with a product that has been successful at phase II trials. Retaining 100% ownership and full licensing are two of many.
Whatever you say Boonco!
You seem to be confusing balanced presenting of arguments, by certain posters, with pessimism. The world is rarely just complete sunshine or heavy rain.
Have you not noticed the share price that is at just over 30% of what it was just before the IBS results? Why do you think that is? Tell the market and II s that they are being pessimistic, not investors who are still supporting the company.
We are not disputing the company's expertise in the area, or positive developments though more recently we've had mainly vague hints of them. The point is however that when you miss by big margins your own indicated timing for the announcement of some results for your flagship programme you simply owe it to investors to explain why. And what's puzzling to me that I first invested in the company in late spring 2020 is that 4D has traditionally been very good at communicating.
As for your statement:
" You don't tell investors any of those things if the current trials are going badly and need refocusing. " Maybe yes, maybe no but it's quite a jump to draw that conclusion!
The argument of directors having put a very significant amount in the company is perfectly valid. Nonetheless, it wanes more and more the further away we get from the time of such investments. Also, it wouldn't be unreasonable to assume that directors were excited in a similar fashion to many investors when we saw the early reports from MRx0518 (last announced in February).
The postponement, at least twice, of major news raises issues and has begun to weigh more heavily. Furthermore, why don't II investors jump on the boat in a decisive fashion? Isn't the main reason we listed on NASDAQ to gain visibility?
Management must have never intended a large time gap between NASDAQ listing and important news re MRx0518. Also, historically they do announce positive news even if they are preliminary. That makes me think that we've needed to refocus the 0518 + Keytruda trial on patients who are more likely to respond.
For a trial of that importance it is not a surprise that we haven't hit straight in the middle of the target straight away (IF that's indeed what happened) - in fact the other way round would have been a (pleasant) surprise.
However, the company should have provided a proper update. By now, the share price reflects a very conservative scenario so they might as well have given us a proper report of what's happening! After all, 0518 and its prospects must account for well over half of the current valuation. Whilst hopeful on the various other projects, they are quite early stage and for some reason, market is still not fully impressed by Blautix results. But let's see what happens by year end.
The above are just my thoughts formed on the basis of the very limited information we've had since February - which is all the more disappointing given the expectations that had been created. But, I remain invested not least because 4D are well placed to deliver results in a sector that all indications show that it will make a major contribution to the treatment of major diseases.
Finally, I agree with what someone said the other day that 4D could either turn out to be a big success story and a milestone for the whole industry OR simply fall well short of expectations. Hopefully, we'll have a good indication of that by Q1 2022.
Whatever reason for the rise, it doesn't seem to be a P&D. There is a lot going on in the 4d powerhouse so lets see whether we keep on getting closer to would be a fairer pre-news valuation : we were at 175p before the IBS news last October and 150p close to Nasdaq listing.. Would be happy with reaching and staying above 75p-80 this week
Could the pivotal development programme the Chairman referred to in the rns be related to the firming up of the potentially (strong) correlation between the biomarker and the effectiveness of the 0518 ? "The main focus of our work in oncology at this time is the preparation of a pivotal development program for MRx0518 in an oncologic indication." Or, are we talking about a fourth / fifth programme involving 0518?! If we were talking about the combo with Bavencio trial, why not mention it? Hopefully we ll find out soon.
This article on 4D's MRx1299 (megasphaera massiliensis) quotes the one in Nature Communications which was referred to in the RNS yesterday:
https://www.nutraingredients.com/Article/2021/07/12/4D-pharma-s-biotherapeutic-may-boost-cancer-immunotherapies
My understanding is that the drug has been shown to work on two levels in mice studies:
(i) one of the metabolites of the bacterium is an enzyme that makes DNA less accessible to transcription factors [and therefore reduces unnecessary cell reproduction associated with cancer ?] The bit in brackets is my speculation as to why reduced DNA transcription is desirable.
(ii) enhances the activity of anti-tumour cells such as CTLs and CAR Ts.
Looking forward to the study moving to the pre-clinical/phase I stage!
Here below's the summary:
4D pharma’s biotherapeutic may boost cancer immunotherapies, study suggests
13-Jul-2021 By Will Chu
4D pharma’s Live Biotherapeutic Product (LBP), appears to enhance anti-tumour activity and increase the efficacy of an immunotherapy used to treat certain tumours, says a German research team.
HTTPS://WWW.NUTRAINGREDIENTS.COM/ARTICLE/2021/07/12/4D-PHARMA-S-BIOTHERAPEUTIC-MAY-BOOST-CANCER-IMMUNOTHERAPIES
Sangijuela, what you state is incorrect. I said it was going to be decision time by late summer/ early September. I did reassess and have been reassessing the desired level of exposure to the company since then.
For the benefit of others, here is an extract from my post in the summer:
"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. "
I referred to "decision time" by early September and
But, you are missing the point on two accounts:
1. You are hardly an investment adviser especially with the level of losses you seem to have accumulated. So telling others to sell appears even more of a joke than you probably intend it to be.
2. It is not about my or your trades. Let's talk about company and fundamentals. Sometimes you do post useful links. Why do you appear being in a state so often?
Being a long term, a short term holder or both is less important than being able to participate in a debate in a mature way and come up with counter arguments rather than petulant responses of the sort "why don't you just sell".
The question is why certain people/pseudo traders get so twisted in their knickers when investors expect the company to do its side of the bargain and give a proper update within the extended timelines it has set itself.
And I say so-called traders. as real traders are supposed to make money every now and then. Judging from the reactions, the so-called seem to be more heavily in the red than most.
Let's hope for more grown up debates going forward and in the meantime, have a nice weekend, We all want the share price to go in the right direction and a proper update might help in that respect. It is difficult to make it worse no matter what the news might be :-)
Overall, we were given very strong hints re management's confidence in the 0518 and some of the other programmes. However, we will need to see very soon the basis of such confidence. Ultimately, data, results and deal are tangible and more useful than assurances aimed at reassuring investors.
Wonder what this statement means:
"The main focus of our work in oncology at this time is the preparation of a pivotal development program for MRx0518 in an oncologic indication. " sounds intriguing.
Otherwise, RNS had information that we more or less know already.
https://ir.evelobio.com/news-releases/news-release-details/evelo-biosciences-announces-positive-phase-2-clinical-data
Probably the reference to the"first successful Phase 2 study" (out of an orally administered drug from the microbiome - see also below) is to an inflammatory disease. Whatever the case, I believe we may well see a strong recovery today. Let's see but any halo effect can only last that long without good news from within the 4D walls.
“These clinical results represent a significant advancement for those who live with inflammatory disease. This is the first Phase 2 study to demonstrate that we can harness the small intestinal axis to make a clinical impact on patients with an oral product candidate with safety and tolerability data comparable to placebo,” said Simba Gill, Chief Executive Officer of Evelo. "
Boonco let's be fully clear : I didn't say that the tweaking was reported or that it was said by you or any other poster. It is just my HYPOTHESIS which could be right or wrong. The reason I think that is because of the delays in reporting the data and the reference to the biomarker (as per earlier post).
I also mistook the following statement from your post to be referring to part B success ratio. Having discovered that the acronym ICI refers to Immune Checkpoint Inhibitor... I realise that such assumption was incorrect.
"AS: MRx0518 + Keytruda: 30% patients respond to ICI. Of those half develop resistance to therapy. Data later this year & into next year."
Haven't seen the presentation but from the helpful reports, it would seem that 0518 needs to be tweaked in order to increase the chances of part B success. We got a hint of that when we had a bit more clarity re the biomarker presentation. Currently, data seem sufficiently promising but the expectations created in part A need to come down. To what extent? Difficult to say but probably significantly.
Let's assume that in part B the reported response rate (to-date) of 30%, whereby half develop resistance to therapy, results in a disease control rate (DCR) of 15% (i.e. the ones who don't develop resistance). In part A 10% was the DCR threshold in order for the trial to carry on. So 15% is close to the part A threshold (NB. That's on the assumption that "response rate" is the same or close to DCR. )
A good way to tweak the trial would be to focus henceforth more on the patients that have the biomarker as the response rate would go up. Hence, among the patients with the biomarker response rate might go up to 30% (just an example) and for the rest 15%. If that scenario materialised, that would still be an unequivocally successful result.
Focussing more on the patients with a biomarker (without dropping others), would make sense. However, the elephant in the room question remains: what % of patients have this? 5% or 50%? We still don't have the answer.
Now, "Late this year to early next year" sounds more like February / March 2022 (at best) - in a way it's a throwback to 4D's earlier days.
Re Blautix and Asthma any negotiations could last a few more months but we could be pleasantly surprised at any time.
Taking into account the above, I'd be pleasantly surprised if we saw anything more than a modest recovery in the share price.
Otherwise, looking forward to seeing CNS entering into clinical phase!
Finally, the above are just my early assessment of the situation and without having seen the results or emailed IR so could be wrong - also I'm not clear on the definition of "response rate" vs. DCR In any case, DYOR.
Last time it was exciting to reach 66p was in August ... last year when we had those successive waves of SP rises from the lows of 35-40p!
Now one step at time: we can expect an RNS very soon with a progress report - management will risk credibility dents if there are further delays in explaining progress to date across programmes and 0518 trials in particular. Seller may carry on for some time but SP fall has now pre-empted average / not fully satisfactory 0518 data! It hasn't priced in failure of main 0518 trial but, if it had been a failure, we would have known by now. So even though share price could easily go even lower, we have reached a point where the potential upside overweighs very significantly the downside. Well, against all expectations, closing above 66p today will be almost as exciting as it was in August 2020 as it might mark the beginning of a trend reversal :-) ...
Any takeover interest for 4d would most likely come from an industry player or someone who understands the pharma and biotech sector very well. I'd view such interest as a very positive development as it would be a (further) endorsement of 4D's IP, know-how and work in general. There seems to be a persistent seller at the moment but the question is why aren't specialist or other IIs jumping to fill the gap and buy shares at such low prices? It's not as if 4D hasn't been exposed to the world of heavyweight investors! The mist around the data of the main 0518 trial is not helping at all. Market doesn't normally like that uncertainty at least not to that extent. If we see further strong evidence that 0518 works then surely it would outweigh and have much more impact on the share price than other factors. But, instead, we get some hints and bits of information upon which it is difficult to draw conclusions. I increasingly think that this is because the situation re 4D's main trial is quite fluid and there are no conclusive data that can be presented yet. Hence it might be that the focus on patients with the biomarker is a natural consequence of that. However, that's speculation and at this stage in the day, we shouldn't have to speculate. Hoping for news very soon.
Hi JR2, re your 09.03 post, I haven't alleged 4D has found a new strain.