George Frangeskides, Chairman at ALBA, explains why the Pilbara Lithium option ‘was too good to miss’. Watch the video here.
Over 1% of the company traded hands yesterday with a 700k buy that went through after hours. Perhaps helps explain why the volume has been extremely low in the last few weeks and why the spread has been oppressively high. I wonder if we'll see an rns in the coming days, Griffiths adding?
Probably a bit of both, as you say. It's certainly a significantly more straightforward procedure than subretinal, but then conversely the effects are less durable (as it only appears to provide trophic support), hense the need to evaluate repeat dosing.
They will also benefit from having a cohort of better responders that they can invite back from the previous study. Whereas reneuron has modified their bleb placement and increased dose, therefore more regulatory hoops to jump through first.
Timings wise, I think this actually potentially now puts reneuron ahead, as the primary end point for our expanded phase 2a study is 3 months, which in principle means readout in Q4 this year.
Assuming all goes well, we should be in a pivotal phase 2b study before jcyte. Or at least that's my take on it now. Plenty of ifs and buts though, as usual.
Apologies, just realised that it states the primary outcome (safety) is measured over 12 month period. So if primary completion is April 2022, then you're right, they should now have been dosed.
Not sure on your info, Treeshaker. The link below indicates that it's active, but not recruiting:
https://clinicaltrials.gov/ct2/show/NCT04604899
Furthermore it suggest that primary completion is estimated April 2022.
Agree that the hope for RP sufferers must be very encouraging.
For reference, this is from the results transcript on 8th July...
Olav
'We’ve done all the investigation around that and be able to restart the study. It’s restarted in the U.S. and in Europe. There is a regulatory step, which is that we need to file an application in the U.K. and Spain to reopen. I believe we filed that one in the U.K. yesterday and we will file in Spain tomorrow. So that’s very much imminent to restart that in those countries as well.'
Beckman
'I think the most important point is that we are going to be enrolling more patients. We do have a three-month cut off, whether we’ll get all nine patients with three months data. I’m sure aiming to be able to do that. Some of its going to be up to the regulatory agencies in the U.K., it ought to take about 35 or so days, spain a little bit longer. Sometimes they’ll help and move that along even more quickly, because I can tell you that our investigators are very much interested in getting restarted.'
So that should be in the next week or two, by sounds of it.
Think they said during the results call that the revised protocol had been submitted and it takes around a month for it to be approved. Once approved they can recommence the trials in UK and Spain. So that means any time now, unless I've mixed my dates up.
It's gone quiet on here and this very much reflects the share price and current low daily volume. The sellers appear to have dried up, but there's not a great enthusiasm for buying either.
Could do with an announcement on the new CFO to stimulate some excitement whilst we wait for hrpc and exosome data in Q4, or even a left field announcement in relation to fosun or ipsc developments.
CFO news could however take a while. They mentioned they were in the process of signing on the dotted line with their preferred candidate, however its probable that the preferred candidate has a fairly substantial notice period to work before they can start with rene. The wait goes on...
Hi hopeful. Good first post and welcome on board. I haven't had chance to do any proper research on Staehelin, so appreciate your input.
Regarding the speculators/investors comment, this is something I would fully agree with. My hope is that institutional holdings continue to increase here and weak hand speculators diminish.
The enterprise value is around 35m now (MCAP minus approx cash balance), which frankly is laughable. At the start of the year I thought that momentum may build and there would be some sustained buying pressure and price uplift throughout the year. However, the hrpc trial suspension seemed to knock that theory on the head. I think its now increasingly clear that the share is going to drag its feet until major data and deals are announced across the next 6 months. At that point the price action could be extraordinary, even by aim terms.
The recent appointment have been extremely interesting in my opinion, and its clear that a renewed focus on commercialisation is developing. Looking forward to seeing the cfo announcement in due course.
Couple of key bits from the transcript of the results presentation:
OH in relation to study progress:
"The exosome program is being advanced in a partnering fashion. While obviously hRPC we’re running ourselves. The data -- we will have more data later in the year, but the data we have already is compared very, very well to what else is out there."
OH in relation to CFO situation:
"And all I can say is that we’ve had excellent candidates that we have found and interviewed and we’re just in the process of signing the dotted line with our preferred candidate. So it’s looking great and we’re looking forward to having the new CFO in place."
OH in relation to Fosun and potential milestone payments:
"But I think the next milestone payment is linked to completing the current hRPC study that’s ongoing. I don’t know if we ever have made public what the milestone is, but that would be the next milestone payment."
OH in relation to licencing deals:
"I have a couple of questions around, when do we expect exosome collaborations to turn into licensing deals? And we expect hope/plan on get the proof-of-concept in one or more of the collaborations that we have ongoing. Obviously, not all of them will lead to that. So that’s kind of a Q4 aim to have that done. After that we expect them to lead into a licensing deal. That usually takes several months to negotiate. So I think that you should think about that as being kind of Q1 next year for a deal. But this is obviously complete speculation. But just to give you some potential timelines around it, there is no deal before it’s signed."
OH in relation to Iain Ross appointment:
"In terms of Board, we announced last week that Iain Ross has been appointed Chairman and we are absolutely delighted to have Iain Ross around. He is, as you know, very, very experienced operator when it comes to biotech in the U.K. We’re really delighted that he accepted the offer to join us as Chairman."
"And I think Iain will really add a lot of value to us. He -- I’m working very well together with him and he has a lot of experience in securing deals for U.K. biotech. So I think it’s great to have him on Board."
OH in relation to the hRPC trial restarting:
"We’ve done all the investigation around that and be able to restart the study. It’s restarted in the U.S. and in Europe. There is a regulatory step, which is that we need to file an application in the U.K. and Spain to reopen. I believe we filed that one in the U.K. yesterday and we will file in Spain tomorrow. So that’s very much imminent to restart that in those countries as well."
All-in-all it was a very useful presentation to watch, as it really puts some meat on the bones and gives more insight into where things stand. The ultimate 'jam tomorrow' company, but when tomorrow comes, I think the jam will be really tasty.
Presentation was interesting to see. Sounded very upbeat on exosomes, with what sounds like highly promising data produced so far, with the aim of refining this through modifying surface loading process. Full POC expected q4, with licencing deals to follow.
CFO lined up with terms all but agreed and ready to be signed, so should be an announcement there very soon it would appear. Mentioned that there have been some very strong candidates.
I think they were at pains to emphasise how important it is that the hrpc study is back underway, and conceded that this should have been announced via a separate rns this morning, rather than as part of the results.
Olav also hinted at progress on fosun trials, seemingly close to suggesting that milestone payments could be close for hrpc.
Worth a watch if people didn't see it live.
I think it's the ultimate 'jam tomorrow' company. But, that said, the next 6 months does sound potentially transformational. If, and this is a big if, they can actually avoid any further delays and hit their own projections!
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.
Silence therapeutics is one of his current non-executive roles. Richard Griffiths has had some serious money involved there, and is obviously increasing his holding in Rene of late. Wonder if this appointment has therefore been recommended by Griffiths?
I also liked the sound of that quote, Clive.
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!
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?