Member Info for PhilBanks

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

Griffiths has taken another slice of the pie. Great endorsement.

"We are the science equivalent of flairs or wide lapels."

Cracking line, Cadbury. I'd never thought of Reneuron as the John Travlota of bioscience, but I'm starting to come around to the idea now!

Regarding Nightstar, this news on the second study was to be expected I guess, following the failure of the first study announced the other month which used basically the same technology. I think gene therapies will ultimately be the main treatment for conditions of the eye, as if the disease can be identified and treated early enough, then it will largely negate the need for cell therapies in order to restore photoreceptors as any disease progression (and therefore loss of vision) will be limited.

However, that scenario is likely many, many years off. If Rene can get it's treatment to market then there are huge numbers of existing patients that are in desperate need of new healthy photoreceptors. Gene therapies could halt the progression of the disease in these patients, but cell therapies are needed to repair the existing damage.

Again referring back to the iPSC platform, a selection of recent collaboration deals below. Perhaps that's why Olav was saying the opportunities are 'huge' and the potential 'enormous'. Food for thought, and again underlines the potential scale of the platform play on offer here.

2nd April 2020 - Fate eligible to receive $50m upfront, and payments of up to $1.8 billion in development and regulatory milestones and up to $1.2 billion in commercial milestone payments, plus double-digit royalties.

https://www.globenewswire.com/news-release/2020/04/02/2011136/0/en/Fate-Therapeutics-Announces-Worldwide-Collaboration-with-Janssen-for-Novel-iPSC-derived-Cell-based-Cancer-Immunotherapies.html

5th Nov 2019 - Allogene will provide to Notch an upfront payment of $10 million. Notch will be eligible to receive up to $7.25 million upon achieving certain agreed research milestones, up to $4.0 million per exclusive target upon achieving certain pre-clinical development milestones, and up to $283 million per exclusive target and cell type upon achieving certain clinical, regulatory and commercial milestones as well as tiered royalties on net sales in the mid to high single digits.

https://www.globenewswire.com/news-release/2019/11/05/1940970/0/en/Allogene-Therapeutics-and-Notch-Therapeutics-Announce-Collaboration-to-Research-and-Develop-Induced-Pluripotent-Stem-Cell-iPSC-Derived-Allogeneic-Therapies-for-Hematologic-Cancer-I.html

1st June 2021 - Heartseed is eligible to receive payments totalling up to 598 million US dollars including 55 million dollars in upfront and near-term milestone payments. Heartseed is also eligible to receive tiered high single-digit to low double-digit royalties of annual net sales outside of Japan.

https://www.pharmiweb.com/pwtoday-story/heartseed-and-novo-nordisk-enter-into-global-collaboration-and-licence-agreement-for-stem-cell-based-therapy-for-heart-failure

14th Jan 2020 - Under the terms of the agreement, Adaptimmune may receive up to $897.5 million in payments, including:
- an upfront payment of $50 million.
- development milestones totalling up to $73.75 million for each product if the collaboration product discovered in this partnership is co-developed and commercialized by both companies
- Up to $147.5 million in milestone payments per product and up to $110 million in sales milestones for products developed unilaterally by Astellas.
- In addition, Adaptimmune will receive research funding of up to $7.5 million per year.

Finally, Adaptimmune would receive tiered royalties on net sales in the mid-single to mid-teen digits.

Under the terms of the agreement, Astellas may receive up to $552.5 million, including:
- Up to $147.5 million in milestone payments per product and up to $110 million in sales milestones for products developed unilaterally by Adaptimmune.

https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/8/astellas-and-adaptimmune-enter-into-agreement-to-co-

Exosome news is much needed now to repair the inevitable damage to sentiment that today's announcement will cause.

The other main thing is the need for clarification about the CFO position. The fact that MH has gone and no replacement has been announced in the 3 months since he gave (or was given) his notice, is frankly amateurish in my opinion.

If the secretary that's now listed on companies House is the new CFO, then it surely needs announcing and we need details of who he is and some credentials. If he's not the new CFO, then it would be useful to know why the company hasn't managed to appoint one in the time frame.

I'm usually the first to defend the company about various things, and I can forgive things not always going smoothly with complex trials etc. However, the CFO situation is something that is purely within the company's control, whether that is announcing an appointment or merely updating investors about the progress (or lack thereof).

Not ideal.

Referring back to my post a few weeks ago about the increasing references to the iPSC platform, I've come across a couple of presentations just recently that I hadn't previously seen. Links below:

Cell & Gene Meeting on the Med – CEO Investor Presentation. . . .
https://www.youtube.com/watch?v=wKco5BP1IFo&ab_channel=ReNeuronLimited

H.C. Wainwright Global Life Sciences Conference. . . .
https://www.youtube.com/watch?v=sbf_MpyiZWE&ab_channel=ReNeuronLimited

Both are presented by Olav, and the content is pretty similar. They also both finish with interesting comments regarding the iPSC platform, if you want to skip to the final 30s or so.

1st video:

". . . and there's another programme that I haven't talked about, which is the iPSCs where we also have huge potential over the next few months. . . "

2nd video:

". . . I didn't go into the iPSCs any further, please go to our website to look at that. It is an earlier stage programme than the exosomes, but the potential is enormous . . ."

Hopefully this will be expanded on in future presentations, but I'm still trying to get my head around what the opportunity is here. I mentioned previously that perhaps the scope is something reminiscent of the type of model Maxcyte offers, which if true, could be exceptional. Any thoughts or insight on that would be most welcomed, as in the words of outgoing CFO Michael Hunt, that area of the business is beyond my pay grade.

Yes, a bit puzzling this. I'm presuming, as grizzlyb has stated, this could be an interim appointment, as surely a new CFO appointment would actually require an RNS?

Go on, own up, who just bought 255k shares at 126p? Massive chunk.

First day Tuesday 1st June then!?

Failed to meet primary endpoint in phase 2/3 trial.

Remember this, along with another similar treatment, was purchased by Biogen a couple of years ago for over $800m. Really does shine a light on the valuations out there compared to Reneuron.

https://www.biopharmadive.com/news/biogen-gene-therapy-eye-study/600204/

Good post PC01. I've only been invested since those highs of 2019, so I pretty bought at the top and then endured an 18 month bear market. I was a fair bit down, but happy to hold. The fund raise at 70p gave me the opportunity to more than treble my stake in the company, and I have increased that further since. As you say, timing is everything, especially with biotech.

In the next 3 to 6 months we'll know if we're going to have a phase 3 asset on our hands for hrpc, and we'll also know if we have exosome POC data and, if so, we will have significant licensing and collaboration deals. Huge and transformational moments for the company if/when they occur.

Updates from Fosun would be the cherry on top, and should not be forgotten, as having a phase 3 potential blockbuster stroke treatment is genuinely possible also.

I think it's perhaps very telling that his research background is especially focused around stem cells and regenerative neuroimmunology. I think it points towards some potentially good progress with the CTX trial in China, and feel like we could be on for an update regarding Fosun, which has otherwise been under the radar since the deal was signed a couple of years ago.

The comments from Olav also sound really quite promising in relation to exosomes as well....

"His extensive experience of cell and gene therapy as well as deep knowledge in the exosomes field will be invaluable to us in what is an incredibly exciting and progressive time."

Really quite positive comments, given the number of exosome collaborations we have underway and how close we appear to be to generating the POC data we require to sign licensing deals.

Just need an RNS in relation to the new CFO and we'll be all set for what could be a truly transformational period for the company.

Could do with some timely rns's to nudge us back in the right direction. More than happy holding meanwhile.

Not directly linked to Rene, but an article outlining just how undervalued many biotechs are in the UK, with the main couple of paragraphs copied below.

https://www.telegraph.co.uk/investing/shares/questor-special-company-list-investors-will-besotted/

'In the words of Richard Penny of Crux Asset Management, which owns a stake in MaxCyte, “investors in the US are besotted with gene editing – they are hugely buoyant about what they see as the third age of drug discovery” built on the decoding of the human genome 20 years ago.

Besotted investors are in much shorter supply here. Britain may have a huge fund management industry but when it comes to the healthcare sector it lacks the critical mass in terms of specialist analysts, funds and brokers found in America.

In fact, you could say we are positively hostile to healthcare start-ups at present. “Fire sales of the small biotech firms held in Neil Woodford’s funds depressed share prices and damaged sentiment across the board,” Mr Penny said.'

The Woodford mess really hit the company hard at the very worst time. The company is currently a fraction of its fair value, on even a very conservative risk adjusted basis (reference Edison and Allenby research notes). Would truly love to see Rene listed on the Nasdaq in the coming years, as we hopefully lead to commercialisation of treatments.

Nice one, thanks for all the links, great research and very interesting to see what the competition is up to. I think it's worth noting that these treatments are pretty revolutionary, so any advancements in the respective fields should be seen as positive validation for the treatment mechanisms in general.

Another link below that people may find informative; I really do think exosomes based treatments and diagnostics are going to be huge within the next 5 years and beyond. Great space for the company to be involved in.

https://www.youtube.com/watch?v=4MeVPYAz7Xc&ab_channel=Lonza

There could be three major bits of news this month potentially.

With reference to the published timeline from the January analyst presentation, the company expects the last of the expanded phase 2a cohort to be treated in Q2 2021. I'm not totally convinced this will be achieved, but we are aware from the LinkedIn post the other week that the Barcelona trial site is now recruiting. Other info on the clinical trails site hasn't been updated since start of March, but you would hope good progress is being made elsewhere too.

The other anticipated event from the timeline is POC data 'for delivery of functional proteins by CTX derived exosomes'. This obviously could be a huge moment for the company if the anticipated data are forthcoming, with outlicensing deals almost inevitable at that juncture.

Finally, from the 12th March RNS, Michael Hunt will be serving his notice until the end of May as CFO. We can therefore assume an announcement will be made on his successor in the coming weeks.

I wonder if its any coincidence that a new CFO is being brought in just as the company is expected to be negotiating potentially transformational collaboration deals on the back of POC exosome data? Looking forward to seeing how it plays out.

I'm struggling to see how people could have expected any more from this trial. Surely just about the best outcome we could have anticipated, given the nature of the disease and the setting. Anyway, will be interesting to hear them provide some commentary at 9am.

https://www.bbc.co.uk/news/health-56906002

Great to hear how this has helped change people's lives. Hopefully one day we'll be reading similar stories about people benefiting from treatments developed by Reneuron.

Certainly a detailed note, and interesting to get further insight especially on some of the less well publicised deals across the market.

What I have also noticed in the last 6 months or so is an increasing number of references to the iPSC programme. I don't fully understand what the potential is here, and also don't really know of the competition. However, I'm presuming it's possible for others to licence the company's iPSC programme in the future as a means of creating and manufacturing whatever cell they want for their own studies. If so (and obviously I freely admit I am speculating), then it perhaps means this side of the business could develop in a similar way to the Maxcyte business model for gene therapy.

Development stage companies paying Rene to use their technology to develop cell therapies, then milestone payments, followed by royalties if the treatments get to market. Almost no risk to Rene, with income streams from a range of potential partners and value getting baked in as the other companies advance their studies. Massive potential if that's the case. Any thoughts welcome on that point, as perhaps I'm barking up the wrong tree, but seems possible.