Member Info for PhilBanks

And in case you are not familiar with the share option scheme I'm referring to, here's the relevant part from the February 2021 rns.

'Share options granted under the Plan and the US Plan (unless otherwise stated) are exercisable from the third anniversary of the award and are subject to the achievement of the following performance conditions:

1) When the Company has signed at least one further significant business development deal for any of its technologies or programmes, one third of the options will vest.

2) When the Company's share price has tripled from the price at the date of grant, one third of the options will vest.

3) When the extended RP Phase 2a clinical study with hRPC has demonstrated efficacy sufficient for progression to a potentially pivotal study, one third of the options will vest.'

Cash burn is lower since the CTX programme was out licenced. The cash runway is probably around 12 months, or thereabouts. However, in that time they really should be achieving licencing deals for exosomes and/or hrpc. Fosun milestone payments (£80m deal announced a couple of years ago) should also be on the agenda in the next 12 months also, so that would extend that cash runway if achieved.

Any licencing deal for either exosomes or hrpc will likely come with upfront payments that eclipse the current market cap, with very significant milestone payments and royalties also on offer.

You would hope that the next raise is in a few years time, when they are IPOing on nasdaq. That may be the blue-sky scenario, but it really should be achievable in my opinion. Just look at share options the board approved earlier in the year, if you need any guidance on whether the company thinks the above is realistic.

I think recruitment status that grizzly refers to is probably accurate. The rns today does imply (at least in my reading of it), that recruitment has been ongoing and that patients have been lined up awaiting the regulatory green light for the actual procedures to now take place again.

The fact that the study is now spread over four sites and three different regulatory bodies (US, UK and Spain) is certainly a good thing in the long term, but has perhaps hampered the progress in the short term. Also perhaps has lead to at least part of the perceived ambiguity of the different announcements we have heard over the last few months.

Anyway, at least we know it is now fully back on track and further patients will be treated this month, with the remaining patients by the end of the year.

A nice exosome, fosun, or ipsc update wouldn't go amiss right now.

Chester, if you do get a response, it would be appreciated if you can share on here.

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.'

Just seen the price here. Totally unjustified drop, I would suggest. I only have a very modest holding here, but will start adding at these levels as the fundamentals are strong. It's a proper business with good margins, excellent client base and solid growth strategy.

I've been searching through the agenda for AAO 2021 and found that we are registered to present on Sunday, Nov 14.

Title: 'PA044 - Subretinal Implantation of hRPCs for Retinitis Pigmentosa: Phase 2a Interim Results'

Presenter: Jason I Comander MD PhD

Purpose: 'A preclinical model demonstrated that transplantation of human retinal progenitor cells (hRPCs) into the subretinal space delays the progression of retinitis pigmentosa (RP). This open-label, Phase 1/2a trial tests the safety and potential efficacy of a cryopreserved formulation of hRPCs administered subretinally in subjects with retinitis pigmentosa (RP) of any genotype. Methods We present data from a nine-subject extension of the Phase 2A portion of the trial. Earlier cohorts showed adequate safety in 12 subjects with severe RP (0.25-1M cells), and preliminary efficacy in 10 subjects with less advanced disease (1M cells). In this portion of the study, nine subjects were treated with up to 2M cells. Subjects with 8-68 ETDRS letters and adequate microperimetry performance underwent pars plana vitrectomy and subretinal injection, targeting cell placement close to the area of remaining functional retina. Results Data at 3 months to 1 year of follow-up is discussed, including safety, acuity, visual fields, full-field stimulus thresholds and microperimetry. Conclusion This study provides additional insight into the potential use of subretinal hRPCs to treat RP.'

It won't let me link direct to the article, but you can hopefully search it here:
https://registration.experientevent.com/showaao211/flow/Attendee#!/registrant//ShowItems/

Very frustrating watching it sink back following the breakout earlier in the year. I've added again at these levels, but that's me now done. . . Although never say never.

I'm very much of the opinion that the odds are stacked in our favour here due to the portfolio of treatments being developed. It would only take one programme to be successful for us to enjoy some significant gains from these levels. If more than one is successful, then the returns could be life changing. The calibre of the recent appointments suggest there is significant expectation from within the organisation, even if the recent share price action doesn't reflect this.

Iain Ross quote when announced as Chairman in July:

“I am delighted to be joining ReNeuron at such a pivotal time and look forward to working with the board and management, and to ensuring a significant uplift in shareholder value over the next few years.”

Catherine Isted quote when announced as CFO in August:

"I am delighted to be joining ReNeuron at what I think is an exciting time in the company’s evolution, not only for the Groups lead stem cell programme in Retinitis Pigmentosa but also for their proprietary Exosomes and induced pluripotent stem cell (iPSC) platform technologies where there is growing excitement in the healthcare industry around their significant potential in a multiple of therapeutic areas. I look forward to working with the whole team and Board at ReNeuron to help realise the opportunity for the company in these leading fields of science.”

wyndrum, yes it either will or it won't. However I wouldn't describe the odds as 50/50. Pro's will be selling chunks at 175p resistance expecting a retrace, amateurs will be buying at that level expecting a breakout. The pros are the ones making money on a more regular basis, that's for sure. The odds are always stacked against a breakout, that's why when it actually happens it's usually spectacular. I'm happy just holding and seeing what happens. Bought some more yesterday, so happy enough with it looking perky.

If it gets through 175p it could well rerate. Think it has a genuine chance this time, after quite a few previous failures.

Hopefully the bottom drawer can be opened soon and it's glowing like the suitcase in Pulp Fiction.

Did anyone here attend the AGM yesterday? Anything of note to report if so?

Hi hopefulmast, good post. You read it the same way I do. We could of course both be wrong, but I really doing think things are lining up very nicely here. It is however increasingly obvious that the market won't care until a major licensing deal is signed. So be it, I'm happy waiting.

Link...

https://www.genengnews.com/news/genentech-adaptimmune-launch-up-to-3b-cancer-t-cell-therapy-collaboration/

Another ipsc licencing deal. Adaptimmune again, this time with Roche. $150m upfront, another $150m over 8 years, plus structured milestone payments that could amount to $3bn, plus royalties.

Such a hot space to be involved in, if rene can get POC for their ipsc platform, then the opportunities are huge.

Decent article below. Mainly about Codiak, but does also discuss the wider exosome development field. Rene manages to avoid getting a mention, but hopefully that will change soon if/when the anticipated POC data arrives in Q4.

https://www.biospace.com/article/un-stranding-assets-with-evs/

Thanks for the responses. Since Obotritia has been brought up, I thought it might be useful sharing a little research on their founder and main shareholder, Rolf Elgeti. It turns out he's something of a serial entrepreneur, and holds various board positions in Germany and beyond. Of particular note is TAG Immobilien, where he is has been chairman of the $4bn Frankfurt Stock Exchange listed company since 2014.

Prior to that, he took over as CEO of TAG in 2009 (aged 33), and since then the share price has increased by around 1500%.

https://www.handelsblatt.com/finanzen/immobilien/tag-immobilien-elgeti-tritt-ueberraschend-ab/10689626.html

He comes mainly from a real estate background (which is the primary business of TAG), but is also expanding into other sectors it appears. He's also behind a recent $200m SPAC with the aim to 'take over a company from the European Union, Great Britain or Switzerland. The focus is on targets from the areas of proptech, i.e. real estate, and climatech with a valuation between EUR 200 million and EUR 3 billion'.

https://www.goingpublic.de/going-public-und-being-public/weitere-spac-fuer-frankfurt-rolf-elgetis-obotech-acquisition-startet/

Who knows if he has similar aspirations for a biotech SPAC in the future - hopefully Reneuron is worth a lot more money before that time comes!

Anyway, certainly sounds well regarded and good to have him as one of the main shareholders here. Unfortunately many of the articles about him are from Germany and typically behind paywalls, anyone able to access this?

https://www.manager-magazin.de/unternehmen/rolf-elgeti-die-wilden-geschaefte-ex-chefs-von-tag-immobilien-a-00000000-0002-0001-0000-000169070110

Correction, there was another 700k trade that showed even later yesterday evening. So around 2.5% of the company changed hands by the looks of things.

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.