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Boonco,
My point is made by reading the SEP 21 statement in conjunction with March update and not reading them individually. RCC is the only disease group advance enough in September to give positive signals to warrant spending resources to plan for a phase 3 study.
I cannot see a balanced argument from you, which is a shame, when you say this ''Also, the quote you highlight from the September ’21 half year report rns makes no mention of rcc. You can speculate they might be referring to rcc but again it’s just that, speculation."
On one hand you acknowledge that they are working towards a phase 3 in oncology but it being in RCC is a speculation and then go on to argue that the talk of phase 3 in oncology itself is a speculation.
My whole point of starting this thread was to highlight the data from 4D and the message they have given us so far with regards to oncology trials. If we are confident of the science and believe the drug has a market and need for patients, we don't have to worry about short term price movements. At least this is what I practice. Speculation will not help me, I am invested in the science and the company and believe it to progress towards approval. If anything materially changes with the science, I will reconsider my investment not because of the short term price movements or potential take over bids.
Boonco, it was in the RNS update and further reiterated during the conference call.. yes, not in the Final results.
But the point does not change.. They were working on it at least from September.. and still actively pursuing it... They need not have to tell us in September or in March but they did inform us. I read that as them getting positive signals from Merck and FDA.
Sorry, for saying that but it undermines the message the company is delivering. We have been told in the Sep-21 update that:
''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.''
and reatirated in April annual report that a Phase 3 in RCC is being developed to include primary ICI patients as well.
So, now take these two things, keeping in view that they have been working on it for 8 months now, each one of us can draw our own conclusions by reading official FDA guidance on the timing of the phase-3.
I will ask for eg:
1) What classification refractory patients will fall in to?
2) What classification primary ICI resistant patients will fall in to?
3) What endpoints and in how many patients we must show clinical benefit?
4) What will Merck gain from if they get this approved for sales mid-way during phase 3?
We don't need to speculate now.. We know things are progressing well.
If big chunks are from SO, then who is 10K seller?? There has been a 10% volume from 10K trades for some days now, I thought it was SO. These big chunks are non price forming trades... more likely shorts closing than SO selling as we haven't seen them during his climb down from 11% to 4.5% holding.. but can't be sure. Well, In any case, them closing shorts/SO selling up now is good!!
But it has taught me many things. The old man Buffet is so true when he advised to only buy the company that one can understand. There were times I was worried when we kept drifting and the data read outs were delayed, making you think if it was a failure. But, knowing the field and how trials are set-up, was the only thing that helped me reason to hold on to it. The data on RCC has rested my worries and as 4D has slipped in the Nov/Dec update and now confirmed, they were working on phase 3 in RCC at least from last Oct/Nov, this will be extended to primary resistant group, this will be BIG!!! Even 5% response in primary ICI resistant group is a step change in cancer care!
Now, I just need to step away and see it unfold and only focus on the data, the rest will follow.
As we are on the subject of mucky city deals.. Just curious if anyone else thinks the today's trading has been 'managed' to let the shorts out? I think yesterday's 125K and today's 250K, 3x 149997, and 411997 (1.5M in total) trades are shorts closing. They are either negotiated prices or OFF exchange traded based on the closing UT trade price. It appears that always know when to close their positions.. well let's see what happens tomorrow!
We are waiting for the good work to reflect in the SP.. The big boys are in it for at least 2025 and expect the company to establish in the market as a mid-level player by then... In my eyes that will be a $50-$75M revenue generating company. Long before that we will have new IIs taking positions to be part of next stage of growth, that should re-rate the stock.
Agree with Richard, one of my reasons to be part of this company is the strong regulation barrier for a new company to enter the market. Only big players can do it but as our CEO said, they prefer to work with finished products and distance themselves from anything to do with handing human tissue. That puts TRX in a very strong position for future valuations.
@Chris - Clinical trials are very complex and must be designed properly to have power to predict the responses beyond reasonable doubt. One complexity with microbiome drugs is that we don't know what the gut-microbiome composition of these patients was prior to 518 or before prior lines of ICI.. so, when we see response to 518, there is always one factor that has not been covered with enough power, which is that somehow the trail has biased the selection of patients with favourable microbiome for ICI/518 treatment. This is something FDA will ask... This is where 4D must come up with power calculations to arrive at a target number of patients for phase 3, that will cover this factor. If we then see 20% response in that cohort of 120-180 patients, then this can be extrapolated, with certain degree of error, to all the RCC refractory patients.
How do you think Merck and 4D will arrive at a valuation for 518? They can't pluck the number from thin air, right? You make estimations of in how many patients it will work and how much revenue it will add per year and do that 5/6/7/8/10 year period and a proportion of that total sales revenue will be offered now to sell the drug.. If it will add $10bn, we will be offered $1bn..
$7.5m will just cover costs for 3 months max... gives us time to raise money when we have achieved the right valuation.. As I said, Phase 3 approved for RCC with an indication from FDA that if mid-trial certain thresholds are met, they will consider approval for emergency use will push the valuation north of $700m.. this could happen in H2, we can raise money then for a phase3, Asthma and Parkinson's trials. Or as we would have de risked the drug by now, a mix of raise and parter sponsored trails..
I stopped thinking about him the moment the RNS landed however, 4D needs to move on now... we need funding guys and that to big time.. When I know that any buy-out will only happen if we show results in phase-3 with at least 20% of Clinical benefit and when that happens it will be north of $1bn (just for 518).. I am happy with a diluted $400 valuation and $150m in the bank now! BUT we can't have this fund around our neck any longer...
Just to clarify, Phase-3 in RCC
In all probability, he has around 100-200K left..IMO. Let's see where we will stabilise in the next week/ two... I hope we will turn a corner now with IIs and aquire a good set on the book.
4D has been working on a phase 3 application from late last year, IMO, so hoping we will see that come through soon.
@HT
I ment “The BIG point guys is we are expanding in to primary ICI resistant group, I can't explain how big that is in the field.. I am sure you will see that reflected in SP soon, as we are Dual listed”
Missed and important ',' ... Aim cannot value this stock properly, Nasdaq will..
Porky, I made a very strong case for 4D, again just like the presentation, it might have bounced over many heads. I personally don't care what happens to SP, this week, month... I want a good set of IIs on the book who will support through the journey of the company.. It helps us PIs in the long run. They will help extract good price from wannabe buys and we will be rewarded for the risk we have taken. I am personally under water still but very excited with the prospects that lay ahead.
Btw, Duncan said that they will look to raise cash this year, and logic says we need it now to have a good negotiation power with our partners.
SO lost a lot of money, he is trying to gain some of it by shorting.. I am sure some other funds are helping him so that they all can benefit, otherwise he could have sold the lot at 75p after the news, he didn't so that he can take an heavy leveraged short position to make money that way and sell up and cash the rest. You might be right, this SP will launch soon, as various funds having done DD will take small positions now as it is lower than future placing price.
The BIG point guys is we are expanding in to primary ICI resistant group, I can't explain how big that is in the field.. I am sure you will see that reflected in SP soon as we are Dual listed.
I don't agree with you Porky9, we have a placing coming, IIs will buy the stock there and capitalise the company to achieve its goals. IMO they will look to value the company based on its portfolio, the field it is in and in relation to its peers. 4D needs around $120M-150M in the next 3 years, the more relevant question for LTH is at what price this placing will be done. 4D need a diverse and stable set of IIs on the book, otherwise will be played by funds and their shadow partners (sorters). My estimate will be a valuation of $400M, fully diluted - around £90p/share - only time will tell.
Science wise, the BIG news is the RCC cohort is being extended to ICI primary resistant group in RCC. This will be massive... as majority of the cancer types share the resistance mechanisms to ICI, once 518 gets ICI resistant RCC to respond, even 10%, 4D would have opened the avenue for rapid expansion of 518 to 1st line and 2nd line therapy - Adding $3-4B/year in sales to Merck. We are being driven by Merck’s science and business needs – I am scientifically experienced enough to understand that it has not happened by chance that 4D is crystallising its efforts on renal and bladder cancers.
Revenue is going up, rate of cash burn is coming down, at this rate projected to be RCF poistive by year end, but the valution is 'crashing' down... wonder why..
Year - Valuation-M - Revenue - M - Event
Jun-10 - 58.4 - 0 IPO
Jan-15 - 144 - 0.82 Invesco and Woodford entry
Aug-17 - 116 - 5.23
Dec-19 - 11.72 - 13.3 Crash of woodford and Invesco
May-20 - 17.6 - 12.8 Placing
Apr-21 - 47.8 - 12.8
Dec-21 - 37.6 - 15.3
Feb-22 - 25.3 - Current
Period Cash burn rate/month
2020 - 550k
2021-H1 - 488k (includes P1 costs and excees stock)
2021-H2 - 150K
The report and the interview appear to me as strategic moves by the company to under promise and over deliver! I do not agree with the revenue predictions in that report, as I know that surgeries in USA had picked up from early April and are now in full swing with increased capacity to clear the back log. Leading on from the positive outlook presented by the CEO and CFO, I was expecting a 30% increase in sales in 2021. But, now by looking at the recent moves, I think we have already achieved growth in sales for the H1-2021 (not flat as the report predicts/expects). For H2, with new production facilities coming online and H2 being the high-volume period for the company, I am now expecting us to achieve more than 30% sales growth and break even as early as Q1 2022.
Interesting chronology of recent events: 1) Insider buying 2) Commissioned report and interview to awake the markets 3) An influx of trades on 12.07.21 – Paid primum to load up shares (I wonder why now?). All this points towards a re-rate of the stock for me, which will happen by the end of 2021.
Thanks, GRH, for the reply, appreciated!
You will be surprised I do not have a twitter account and I am not at all old, just have no use/time for it. However, I do value your opinion enough to create one now, I will send you a message today.
While I do not want to share it here, when I send you the message you will recognise my twitter handle (which will be my name), as it will contain elements of LSE id, RN1mlt, hope you got the clue!
Best,
R