Member Info for onceaday

FDA APPROVES FIRST-IN-CLASS EVKEEZA™ (EVINACUMAB-DGNB) FOR PATIENTS WITH ULTRA-RARE INHERITED FORM OF HIGH CHOLESTEROL

Thanks! Very helpful. The fact that the article is published in such a prestigious journal increases its importance enormously.

and another..
RST-001 Phase I/II Trial for Advanced Retinitis Pigmentosa - Sponsor:
Allergan
Phase I/IIa, Open-Label, Dose-Escalation Study of Safety and Tolerability of Intravitreal RST-001 in Patients With Advanced Retinitis Pigmentosa (RP)
Actual Study Start Date : December 14, 2015

For anyone interested in doing research into the RP marketplace..

NEW YORK, June 16, 2020 (GLOBE NEWSWIRE) -- Bionic Sight, LLC announced today that it has dosed the first patient in the Company’s Phase 1/2 clinical trial of BS01, an optogenetic gene therapy for patients with Retinitis Pigmentosa. This is an important step toward bringing BS01 forward as a treatment to enable patients with retinal degenerative diseases to detect light, motion, and shapes, with the ultimate goal of restoring eyesight.

Optogenetic proteins act essentially as converters; they receive light and convert it into neural signals. Bionic Sight’s therapy delivers the optogenetic proteins to the optic nerve, which sends the signals to the brain.

Phil.. I sold out last week having bought a significant stake in the open offer. That got me back to about even overall.

I've lived through the ups and (mostly) downs for the last 3 years. I've watched endless Michael Hunt presentations promising that the next infection point is just around the corner and believed it even when it didn't quite seem plausible. Everyone has to make their own decisions about the quality of the management. I have had much more success in US biotech lately, my star purchase being Chimerix a few months back.

No hard feelings. I wish all LTH every success.

Covid will delay the delivery of the RP program. The Barcelona site will be delayed by the huge increase in infections seen in Spain and by the failings of the EU vaccination program. Likewise, does anyone really think an NHS hospital in Oxford is going to open for experimental procedures when COVID is ripping through the population and there is a massive backlog of procedures? We are now looking at lockdown until the summer. In the US, Biden has said things will get worse before they get better so I don't hold out too much hope that the US will rescue the program.

I think it's wise to follow the CEO and CFO. I'm sure Olav and Michael Hunt have significant investments given their likely wealth and it's a big concern to me that they chose not to invest in the company, even at 70p.

I watched the recent analyst presentation. My view is that , as has so often been the case with this company, they will miss their target dates. The progress to date on the PH2a extension trial has been really poor. They had permission from the regulators in June 2020 to start. In 6 months they have treated only two patients. This says a lot about their sense of urgency or bad planning. Olav stated in the presentation that they will treat all nine by early Q2. Except that this will be during what will effectively be the worse stage of the pandemic in the US and Europe . I have no faith in their ability to deliver to these dates and failure will mean they will not have data to present at conference as they have suggested in the summer.

Anyone find it strange that, despite a salary of £500k, Olav invested only £20k in the latest fundraiser, or that the CFO, Michael Hunt, shelled out only £15k?

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

Hi Shandypants2

You said that "Only last week the end of 2020 date was reiterated". Can you tell me who was the source for that?

Thanks

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

Very encouraging. I just wished that managed to get the share price higher before giving away half the company!

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..