Charles Jillings, CEO of Utilico, energized by strong economic momentum across Latin America. Watch the video here.
I'm not in any way anti-vax, but from my own experience I had the pfizer vaccine and after the first dose had heart palpitations and fluttering etc for around a week afterwards. Foolishly waited a month before actually going to the doctors after I read an article about that vaccine. They did tests and said everything looked fine. I asked if I should go ahead with 2nd vaccine despite what happened with first dose and the doctor said 'we always recommend you have your second dose'. I'm 36 and just don't think the risk reward profile is in my favour for having the second dose, doctor seemed to just ignore that and gave me the stock answer.
I mentioned in the telegram group yesterday that the Retina UK video description states the following:
'ReNeuron:
Still at phase 2, but there are a very small number of UK participants – just two or three at Oxford – and the BBC have filmed a news piece. Results of phase two by middle of 2022, then will decide whether to move forward to phase 3.'
So they've already done the filming. The first patient was treated at Oxford 18th October.
https://tools.euroland.com/tools/Pressreleases/GetPressRelease/?ID=3976417&lang=en-GB&companycode=uk-rene&v=
BBC wouldn't be doing a piece about a treatment that doesn't work; presumably waiting for Reneuron to release preliminary data in Q1 2022 before the news piece goes on TV. Are we back to being excited about hRPC again??
Yes, sorry meant 1:100. Think OH and MH picked some up around 200p in February or March 2019, and both again in the 70p raise this time last year. Not huge amounts though obviously, but as stated, they both have significant options, as does the new CFO.
I think it's not just linked to the level of progression of the disease, but also the gene defect that has caused the RP. Cones and rods affect different aspects of the vision. I think (but admittedly don't know enough about it), that gene defects that cause the cones to die off more rapidly, are the ones that are most associated with decreased central visual field at an earlier stage. I think rods are more to do with light sensitivity.
If the above is true, the jcyte subset may well be restricted more by gene defects that are linked to cone degeneration. The same of course could ultimately be true for Reneuron's treatment, but the dataset isn't big enough yet to draw any conclusions. This may also be why we had some really fantastic responses in certain patients at 1m cells, and then some not so great responses in other patients. The key is to getting more and more patients through the trials as data is king. Very disappointing how long it's taking to get people enrolled currently.
Epsilon, I think you have touched on something very important there; Jctye are looking at a subset, and we could really do with knowing what percentage of the RP population fall into that subset. Probably something that Rene themselves know, but certainly something Jcyte will know, and perhaps its not a particularly large number, hence why they are looking at redosing studies and appear to be still a long way off commencing a phase 3 trial themselves (slated to begin early 2023, according to their Clinical Operations representative).
I've wondered if there is scope for doing both sub-retinal and intravitreal at the same time? A single 1m bleb subretinal site, plus a 6m cell intravitreal dose. Perhaps it's all too much at once, but would be interesting to know if it's at least been considered.
Very reasonable points, grizzlyb. The market can be illogical at times and you do have to step back, look at the facts and trust your own judgement. Admittedly this can be difficult when the SP is taking a hammering.
You can't rule anything out, but I personally doubt a raise is coming. They said there is a 12 month cash runway (minimum) from the start of this month. If they don't sign an exosome licencing deal in Q1 2022, then I'll be genuinely amazed. This will come with significant upfront payments that would potentially negate the requirement for any fundraise for a number of years.
Lots to digest from the interim results presentation, and I think that the company are clearly very excited about the developments that are taking place in the ongoing studies.
The information presented in the slides was quite illuminating. Of particular note (for me) was the slide that showed the progress with external partners. The one with the 'global pharma' partner indicates that the payload is an HDO, or heteroduplex oligonucleotide.
Below is an article from The Scientist publication regarding a breakthrough in the delivery of HDO from August 2021.
What I find particularly interesting is the comments from a couple of scientists who reviewed the study findings...
"The data seem strong,” Rudy Juliano, an emeritus professor at the University of North Carolina School of Medicine who did not participate in the study, writes in an email to The Scientist. Open questions, he adds, include whether most of the effect observed in the whole brain actually took place in neurons and not in supporting tissues, if the high doses the authors used—50 milligrams of HDO per kilogram of body weight—can be toxic, and why “this simple modification of oligo structure can overcome the extremely robust blood-brain barrier that limits the access of much smaller and much less polar molecules to the brain.”
“The first thing that struck me was the enormous dose that they are using. Fifty milligrams per kilogram is very high,” agrees David Male, a cell biologist at The Open University in the UK who was not involved in the work. It’s important to consider the dosing for clinical applications, he adds. “You might want to knock down inflammation in the brain in say, multiple sclerosis. You’re probably going to have to be giving quite sizable doses on quite a long-term basis if you’re just giving an oligonucleotide, which doesn’t effectively regenerate itself.”
https://www.the-scientist.com/news-opinion/antisense-oligonucleotides-cross-rodents-blood-brain-barrier-69104
The question therefore is whether the Rene CTX derived exosomes can replicate the loading and delivery efficacy across the "extremely robust blood-brain-barrier" observed for the therapeutic proteins announced by Rene in October. If so, then we may too be reading about further breakthroughs in The Scientist before long.
Elephant in the room is this:
'The data from the extension study and the earlier lower dose cohort will inform the Company as to the preferred dosing based on its efficacy and safety profile, whether sub-retinal delivery provides the optimal efficacy and duration of action and the commercial potential. The data will support the decision whether to move straight into a pivotal trial or whether additional subjects should be treated to garner further sub-retinal data and also whether to investigate further a move into the clinic with an intravitreal dosing regimen.'
Think they must not be getting the improvement in efficacy data they were hoping for from the increased dosage, based on the initial patients treated in the expanded phase 2a study. The data can still be good, but perhaps not to the extent that it outweighs the increased risk of having two subretinal bleb sites.
However, as they have previously stated, they think based on 1 million cell dosage they have an approvable efficacy signal, so not exactly a bad position to be in when designing a pivotal study.
What I think is telling is the Chairman's statement, as follows:
'Despite the breadth of our stem cell based platforms, if we are to succeed, we need to be prepared to make tough decisions and only progress and invest in those programmes whereby true value can be created. Accordingly, where necessary we will look to share the value creating potential of our assets to secure substantive third-party collaborations, thereby increasing significantly the probability of success in terms of product development and value creation. The Board and management team will continue to assess all opportunities to create value through organic growth but also, as appropriate, explore technology licensing and acquisition opportunities to accelerate and enhance the overall value proposition of our Company.'
For me, reading between the lines, I think 'tough decisions' refers to out-licencing hRPC programme once the data is in at Q1 2022. A pivotal study would be expensive, and I think they would now be happy to take a licencing deal with upfront payment and royalties, and let someone else take on the risk and expense of the pivotal study.
The strategy to me now seems clear; put everything behind the exosomes programme in the near term, because the opportunity they have is potentially huge. Talk of potential 'acquisition opportunities' perhaps relates to how they can expand/scale exosome manufacturing, and presumably whether that can be funded by selling the rights to hRPC.
That's my take anyway. See if they put any more detail forward during the presentation later.
Olav...
"We feel we are in the right place, at the right time, with the right technology to be a leader in exosomes and look forward to providing further updates on our progress as the excitement in this area continues to grow.”
Sounds good to me.
I would strongly agree with your comments there. For me the platform play opportunity is fantastic, there is a breadth and depth to the programme which for me is compelling...
CTX; stroke and huntingtons
hRPC; retinitis pigmentosa, cone rod dystrophy, AMD.
Exosomes; parkinsons, Huntingtons, dementia, CRISPR/CAS9.
iPSC; nerve damage, CAR-T and NK Cells, pancreatic islets/diabetes.
If they can hit any one of those areas the returns are huge. The beauty of course is that if they hit one then its means the technology has been validated in a clinical setting and other approvals/breakthroughs will follow.
I'm pretty sure any other company on any other market would be basking in sunshine following 2 announcements in 6 weeks demonstrating validation and POC across two potentially huge therapeutics areas/platforms.
But no, this is Rene and it resides on AIM. Its up 18% in total across the two major announcements, equivalent to an £8m increase in MCAP.
My best advice (which I'm trying to listen to myself) is sit tight and just ignore this share until the licencing deals start be announced. The value is clear and obvious, its well and truly baked in now, but the market won't care until its backed up by cold hard figures and upfront licencing payments.
I feel like we're on the precipice of something big. It's as though the company is starting to blossom after many hard and long years of research.
The CTX line for stroke will hopefully one day make it into the market, but even if it doesn't, I'm certain it's legacy for CTX derived exosomes and iPSCs will bear the fruit and realise the promise that 2 decades of R&D deserves.
Credit to Donald jrn on the telegram group for finding this. Extract from an interview with the fosun executive president in Nature...
'Another example is the Shanghai Key Laboratory of Stem Cell Therapy we established, the first of its kind led by a private enterprise. Focusing on regenerative medicine, the laboratory is now driving the development of two stem cell therapy products, one for stroke recovery, the other for treating pigmentary retinal degeneration, both of which are in high demand. By bringing in advanced technologies and talent from abroad, we are striving to make the laboratory an advanced technological platform for stem cell research. We will also promote research commercialization with this platform, driving clinical studies and technology transfers.'
https://www.nature.com/articles/d42473-021-00192-6
I first head about the company in March/April 2019 when the hRPC results came out and Fosun deal was announced. Managed to bag some at around 200p, then again at about 260p. Only modestly investing at that stage, but nevertheless annoying to first get involved at those levels and then watching it drop back, especially with how the Woodford saga tanked the sentiment, then covid and then fund raise.
Since then I have continued buying as I have researched more and more. I bought very heavily between 70 to 80p at the end of last year, and bought heavily again at low 90s in September this year. Had another dabble on the morning the exosome news got released at around 110p, as I couldn't believe it wasn't 50% or more up. If it goes low 90s again then I'll buy more, but really quite overexposed now.
As PC01 says, a couple of years is nothing compared to some of the hardcore long termers on here. Some might call them a glutton for punishment, but hopefully their (our) rewards are now very close indeed.
Because PIs are impatient. It doesn't matter though for me, I've learned to accept this impatience now and will not become disheartened at paper gains slipping.
Personally I've never been so happy and confident with my investment since the exosome POC announcement.
Licencing deal(s) will happen for exosomes and you'll either be in or out when that news comes. I'm in heavy and now just trying to switch off from it until the news arrives.