Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Ultimately the fault lies with the CFO, Michael Hunt. It's his job to keep the company well funded and raise capital at the most advantageous point for existing shareholders. He should have been raising money in 2019 when the share price shot up 400% to £3 regardless of how much they had in reserves. Instead, he took a risk on future results, and existing shareholders have been heavily diluted as a result.
A quote from Vitor Pharma's half-year report "The impact of the COVID-19 pandemic reduced revenues of Ferinject®/Injectafer® and Veltassa®in the first half of the year."
Given further lockdowns and worries about vulnerable people visiting hospitals, it seems possible that this will continue for some time. If Shield and Norgine have their wits about them then they should be able to leverage the demand for alternatives.
Chester
Any COVID-related delay in the RP trial is likely to be due to choosing Oxford Eye hospital as the third site. You can see from clinicaltrialts.gov that Mass Eye and Ear and the Retinal Research Institute and both recruiting. I can understand why Rene is willing to wait for Prof. Robert Maclaren at Oxford given his hugely successful work at Nightstar. I hope he achieves the same stunning results for RENE.
https://www.edisongroup.com/publication/funding-to-complete-phase-iia-and-other-projects/28429
By the way, I would have a look at what Lineage Cell Therapeutics are doing in dry AMD for another comparator. They are targeting RPE cells rather than cones and rods but it seems a pretty similar methodology albeit for a different indication.
I agree, it is not all plain sailing, by any means. I think we have both been here a while and know their record on delivering anything on time is questionable and that their shareholder communication could be much better. However, as I understand it, JCyte's and ReNeuron's hRPCs cells are not that dissimilar - given that fact and their extensive IP estate at least underwrites the current valuation so I don't see 9p as a real risk.
ARM = Alliance for Regenerative Medicine (ARM) "the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. As the global voice of the sector, ARM represents the interests of 360+ members across 25 countries, including small and large companies, academic research institutions, major medical centers and patient groups."
Michael Hunt is on the board of directors. I think I read he was a founding member in Europe - it must have grown an awful lot since those days.
If you check youtube, you'll see all the ARM Gene and Cell meetings on the Mesa - still waiting for 2020's to be uploaded.
I see that ReNeuron is presenting on April 16 at the ARM "Meeting on the Med 2021". It may be slightly early to announce RP data or it may not be their chosen forum (they may want an ophthalmic conference) but fingers crossed we get something
It's a good point. Not sure how much of the placing was EIS.
I believe if the price rises and the shares are sold within 3 years then tax is calculated at 30% of the sale price - but happy to be corrected if I got that wrong.
https://clinicaltrials.gov/ct2/show/NCT04604899?sel_rss=new14
This is interesting because jCyte are, as previously stated, testing repeat injection of hRPC. They know that the cells do not remain in the vitreous for extended periods, unlike when placed sub-retinally. This is interesting to note because the trial will not complete until 2022.
This could have implications for jCytes clinical development timing and allow RENE to catchup or overtake..
https://www.fightingblindness.org/news/inherited-retinal-diseases-cost-the-us-and-canadian-economies-up-to-33-billion-annually-201
This shows the potential rewards for the RP program. I expect at least 5 x the current price (and possibly more) within 12 months
I think the first we will know about it is when they announce that a US investor has bought in. There won't be a public cash raise.
Michael Hunt (CFO) admitted that they would probably need to raise funds before any partnership deals were penned in 2021 but he also stated that the amount required would be moderate and easily achievable.
The price is heavily discounted, partly because of a potential dilution and also partly because of concerns over the effect of COVID on the PH2a extension timetable. I suspect once fundraising is announced, the price will rise not fall.
https://www.choate.com/insights/routes-to-exclusivity-in-cell-based-therapy-development.html
Yes, he is correct. You should read the section on clinical superiority to understand eligibility.
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findings
Founded in 1994, Shanghai Fosun Pharmaceutical Group (Fosun Pharma for short), is one of China’s most well-established pharma firms, active in both innovative and generic drugs. Fosun boasts a global footprint, manufacturing and R&D facilities, and a strong presence in medical devices and diagnostics, healthcare services, and pharmaceutical distribution and retail.
Fosun has multibillion dollar revenues and will have no problem funding the CTX stroke trial which is their primary interest, I believe. I expect them to proceed at a much faster pace than RENE have simply because of their resources.
It's true they are also working on the COVID vaccine but that is unlikely to affect the plans for CTX.
Ok - that was actually more informative than MH's presentation. There were a number of points I was really glad to hear:
1. He acknowledged that jCyte had good results in their Ph2b but he expects to beat them with the 2M cell dose.
2. He recognised that COVID could derail some of the trial sites so they are planning on more for contingency so that the trial is not delayed.
3. They expect to revisit partnering for the hRPC program next summer . The timescales make sense given that the primary endpoint in the extension study is at 6 months (see clinical trials.gov). Dosing all the patients by Q1 next year and results are evident after 30 - 60 days.
4. Exosome collaborations are ongoing but they are playing things close to their chest (they are probably under NDA anyway) but at some point news will break.