The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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So my question about CTX status was the first in the Q&A session today. Olav's answer was that Fosun have been concentrating on tech transfer and manufacturing. Unlike some China deals where the drug or.biologic is imported, Fosun have chosen to produce in-country. He also said they were very committed to the stroke program, principally because of the high rate of smoking in men in China. This is a known contributory factor in stroke.
I would have liked more info on recruitment into the trial but he eithwr doesn't know or can't say (probably the later).
Well at least there’s a little movement in the right direction….
If this was listed in the US it would prob have a $10b market cap lol
If you can't access that FT link, here's the main point of interest:
'By 2012 Silence’s investors had lost patience. The shares had hit a low of 38p, valuing the group at less than £10m, and it was “just weeks from going under”, says Mr Mortazavi.
Three years ago he bought shares, joined the board and then brought in his former boss Richard Griffiths, as well as Robert Keith, a serial backer of technology ventures. Between the three of them, they own about half the group’s shares.
Mr Mortazavi and Mr Griffiths had worked together in the early noughties at Evolution Securities, a small aggressive brokerage firm chaired by Mr Griffiths, a former Welsh hill farmer, professional rugby player and a somewhat controversial and unconventional figure in the City.'
The Ross/Griffiths link appears to run deeper than just SLN, after a bit of digging it turns out that E-therapeutics (Ross was former Chairman) is also a Griffiths holding. So in summary;
Silence Therapeutics – Iain Ross is Chairman; Richard Griffiths holds 26% stake
E-therapeutics – Iain Ross was Chairman; Richard Griffiths holds 28% stake
Reneuron – Iain Ross just appointed as Chairman; Richard Griffiths holds 8% stake (and increasing)
https://www.proactiveinvestors.co.uk/companies/news/912636/former-silence-boss-takes-over-at-e-therapeutics-in-board-overhaul-launches-16mln-placing-912636.html
And, if you read that link above, you'll see the name Ali Mortazavi mentioned, who went into Silence Therapeutics heavy alongside Griffiths:
https://www.ft.com/content/f03a37f6-e4ea-11e4-8b61-00144feab7de
Any why is that relevant? Because Ali Mortazavi also picked up 2.4% of Rene in 2019, along with a 770k share 10 year spread bet as well, it would appear:
https://www.investegate.co.uk/reneuron-group-plc/rns/notification-of-major-holdings/201903050700298087R
I think it's becoming more and more clear who are pulling the strings around here now.
Found this from Redx Pharm RNS, when Iain Ross resigned 1 month ago:
'Lisa Anson, Chief Executive Officer and a Director of Redx Pharma Plc said; "Iain has been the lynchpin in the turnaround of Redx and we are very grateful for his innumerable contributions as Chairman over the last four years. It is as a direct result of his strong oversight, counsel and expertise that Redx is now in a strong position, with supportive specialist life science investors for the next phase of the Company's evolution. Personally, I would like to recognise his contribution and thank him for all that he has done, and on behalf of the Board wish him every success in his future endeavours."
Iain Ross, Non-Executive Chairman of Redx Pharma Plc commented; "It has been a privilege and pleasure to have chaired the Redx Board through the challenges of the last four years and I leave the Company well financed, with an exciting product pipeline; a strong management team and a high-quality shareholder base. I believe my job is done and I am planning to take on a new role within the sector. I wish the Company well and will remain a supportive shareholder."'
It seems he was appointed there in 2017 as they were in the process of going into administration. He was executive chairman for around a year, and then was involved in appointing the then President of AstraZeneca UK as Chairman, whilst he stepped back into a non-executive role.
https://www.proactiveinvestors.co.uk/companies/news/195633/redx-pharma-shares-soar-48-after-it-recruits-heavy-hitter-from-drugs-major-astrazeneca-195633.html
So anyway, he's packed it in at Redx with the company worth $200m and the share price at a 5 year high, to come and hopefully make some waves at Rene. Seems to know his onions, and would appear to be a cracking appointment.
Thanks for the pep talk Clive, we really need it. I don't dare sell my shareholdings as I've had so much invested in this company and believe in the science. It would be a sickener for it to take off just afterwards.
Prospero17, ReNe certainly has been plagued by lack of good PR and events like Woodford and management of communications etc. However, I do believe the RNS this morning with Iain Ross’s appointment is a signal of times are changing, this on the back of the appointment of Dr Stefano Pluchino as Chief Scientific Officer is sending the right message to the market. Worth noting Iain is also non exec Chairman of Silence Therapeutics which are to dissimilar to ReNe and since he joined their share price is uop 742% in 2 years and 4 months. See their results 30.03.21 - https://silence-therapeutics.com/investors/press-releases/press-releases-details/2021/Silence-Therapeutics---REPLACEMENT-Silence-Reports-Full-year-2020-Results/default.aspx. So for all of us patient long standing shareholders I do believe things are changing wioth stronger management. The no2 in the Finance department just needs to be clai=rified if he takes over or not. Bu=t I am heartened by their recent appointments which do bode well for the future. Keep the faith we will be rewarded.
Actually historically with goods news the price rises beforehand and then drifts down almost immediately. With bad news it tanks, and with no news it gradually drifts lower. Based on 14 years of experience which has seen the SP drop 85% in that time, while the rest of my portfolio is up around 200% over the same period. How can the SP be a seventh of what it was 14 years ago based on the technological, funding and licencing advances?
Very true
With this share there is only patience. With good news it will rise, bad news it will sink, no news it will drift. Currently we are drifting.
Getting fed up with this share tbh
Thanks onceaday. Do you have any professional experience of this process, or are you mainly familiar with it through your dealings on the stock market?
What you're saying would certainly go a long way to explain why the company has been quiet on the matter, and does keep alive the idea that we may have a phase 3 candidate on our hands, even if we can't quite find it!
My experience of licensing deals is that, after the technology transfer phase is complete, the licensor may not have that much to do with the licensee's development program. In any case, you are absolutely right, RENE would be unable to disclose anything regarding FOSUN's development without explicit permission - not least because it would be market-sensitive information (for FOSUN).
I wouldn't put that much faith in Fosun, they took a large stake in Thomas Cook and look what happen there.
They haven't tracked me down yet, so can't comment on the food in camp!
Thanks for your thoughts on those two trials. I'm pretty certain they're not ours, but it does beg the question where ours are therefore listed/registered.
Given that CTX is showing as a Phase 3 study on the Fosun documentation, you would think Rene would be shouting from the rooftop about this. It leads me to think that either it's a mistake on the Fosun document, or that there is some confidentiality clause that stops Rene from publicising the status without consent from Fosun. Not sure how that sits with the regulatory disclosure requirements for AIM though, as progression to Phase 3 is surely market sensitive information?
I agree, neither study really matches. The first trial is using RPE (cells) rather than hRPC. The second is similar to the CTX trial but I would expect it to have explicitly stated if they were CTX cells.
Anyway, how's the food in the camp :-)
I have tried extensively to find the details of the trial(s) on the Chinese Clinical Trial Registry (ChiCTR), without definitive success. I can find certain trials that sound very similar, but the dates and finer details don't seem to stack up.
Example below which sounds right for hRPC, but then the ethics committee date doesn't align with what we know about the timing of the Fosun deal, and the Phase is down as '0':
http://www.chictr.org.cn/showprojen.aspx?proj=62764
Also this, which sounds very similar for CTX, but the dates just can't be correct, and the cohort size (18 no.) surely can't be sufficient:
http://www.chictr.org.cn/showprojen.aspx?proj=24530
CTX and hRPC cannot be found by name on the ChiCTR site. And to confuse matters further, 'Fosun' does not return any results under the 'Applicant', 'Study leader', 'Primary sponsor', or 'secondary sponsor' fields. It does however return a few results under the 'source of funding' field, however that mainly relates to vaccine development. ReNeuron cannot be found under any of the fields.
I don't know if trials for drugs from foreign companies are registered elsewhere perhaps, but my searches have been pretty exhaustive on the ChiCTR website, without definitive success. If you have any thoughts on the two examples I've provided, please let me know your opinion.
I'm probably now on some Chinese military surveillance list, so if you don't hear from me again, please inform the relevant authorities.
Very interesting. I had a quick look back through the RNS catalogue and found this extract
JULY 20, 2020
Source: RNS
RNS Number : 4161T
"Clinical trial applications have recently been filed by Fosun Pharma to open clinical sites in the licensed territory to build on the Phase 2b clinical data already generated with the CTX cell therapy candidate for stroke disability...."
Assuming the regulator in China agreed, the CTX trial could have started at the beginning of this year. I'd estimate 3-4 years for headline results for a pivotal phase III. We could see approval in China as early as 2025.
That is really very interesting Phil. I had assumed from our CMO's recent panel discussion that we'd experienced delays in China due to ethical concerns around stem cells, however from your link it looks like Fosun are close to New Drug Application stage. That would be massive.
https://youtu.be/0PfkmSzNjp4
See link below for a presentation issued by Fosun (dated 31st March 2021) in relation to their end of year accounts. Navigate to slide 24 of the presentation, to the page titled ‘Strengthen Innovative Capability of R&D Pipelines’.
Under the 'non-tumour' section on the right-hand side of the page, both the CTX and hRPC trials are listed.
According to this, CTX is now in a Phase 3 pivotal study, and hRPC is either towards the end of Phase 2b, or just starting Phase 3.
If this is accurate, the implications are potentially huge. CTX has blockbuster potential and whilst I would prefer to see such progress towards an FDA approval, any such progress in China only serves to validate the efficacy of the treatment and provides a compelling indication of what we can perhaps expect elsewhere.
https://ir.fosun.com/static-files/ac89d12d-bbcc-4ce9-b642-e489dc363b8f