Lineage Cell Therapeutics Inc (LCTX)

[Spideyboy]

I had a little time to look over my stocks today I just had a little review of the competitive landscape and clinical trials in Dry-AMD.

I found the trials that were mentioned by the Lineage Corporate presentation, whereby I was focusing on cell therapy trials in the Phase 1/2 stage, which I understand to be latest of all Dry-AMD trials.

Of the competitors that the corporate presentation mentions and which I found, there are essentially just,

- Astellas
- Regenerative Patch Technologies


--For Astellas:

What is interesting is this is actually an old company I used to be invested in call Advanced Cell Technologies, which then re-branded as Ocata, which was then sold by a crony CEO to Astellas, thus becoming/creating the Astellas Institute of Regenerative Medicine (AIRM).

What is interesting to note is that Astellas after having completed a trial in 2015, then started a new trial in 2015, only to have it withdrawn in 2017 due to "Withdrawn (Changes to the study design and the cell line)". And since then nothing. That's already 3 years of nothing. Perhaps as growing the new cell line itself will take years to get to clinical trial application?
https://clinicaltrials.gov/ct2/show/NCT01344993?term=dry+AMD&phase=1&draw=2&rank=2
https://clinicaltrials.gov/ct2/show/NCT02563782?term=dry+AMD&phase=1&draw=2&rank=3

So it seems at present AIRM isn't really a competitor.

-- For Regenerative Patch Technologies (RPT):

First off the technology sounds a little cumbersome and from logical standpoint I see a few difficulties/flaws in making the technology actually work, but secondly and more importantly, their Phase 1/2 trial was started in 2016 and with an Enrollment Target of just 16 patients. It is apparently 'Active, not recruiting' which would normally mean that all patients are enrolled and just awaiting end-points. However, the end-points are at the 1 year time-frame.
https://clinicaltrials.gov/ct2/show/NCT02590692

Lineage started its study in 2015, but to date has recruited 21 subjects, over 16 of which having pretty much full 1 year data on all these patients. It is of course possible that RPT is still waiting for the last 2-3 patients to get to the 1 year mark, which would logically be soon. However there is something else very interesting to note.

Regenerative Patch Technologies went radio silent in 2018. The latest News posting from the website are from 2018, and the website's footer itself, states 2018, when normally this should be updated each year. And no offence but the website looks like it was made by a teenager about 10 years ago.
https://regenerativepatch.com/news

The most recent thing I can find of theirs is a youtube video from Oct 2019, where they 'are going to be reporting all of the data on all 15 patients that have been followed up for a year'. Thus showing their trial did in fact end in 2019.(notwithstanding the 16th patient that appears enrolled on the clinicaltrials website.

Thus it seems to me that the website having gone radio-silent in 2018, and no results on the 15 patients where the full data was available end 2019, would suggest Regenerative Patch ran into either product, management or financial difficulties.

And finally the point of this whole post, is that therefore it would seem to me that there is no real cell therapy based competitor for Lineage Cell Therapy in the Dry-AMD space. Which if OpRegen continues to work as well as it seems, would be great. Note the results so far in Cohort 4 are impressive, the first instance of regression of GA is impressive, and the exclusive license of the SDS delivery system could make this actually work.

Any thoughts on all this?