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IMHO the trials are there to show that the procedure is safe, safe over time, and has benefits.
It seems to be safe. In particular the device they are now using was approved by the FDA.
In terms of safe over time the trial details talk about following each subject closely for 12 months and then less often for 5 years.
At the start of the trial it talked about improving vision, or suspending the decline. Now we are seeing some improvement consistently.
The trial started in 2015, it is scheduled to end by December 2020 (although LCTX just said speed up the last bunch of people).
At that point, We should know the initial benefits (I'm expecting that in May). Then the question becomes, do they really need to wait for another 5 years to check the last people to be treated, or will they look at the safety from the people treated at the start of the trial.
OpRegen has FDA fast track approval. If the benefits are clear enough, will the FDA approve this early? Will the stock price increase when people see the benefits, but before the FDA approval?
That's nice to see. The information came from a talk in June 2018 (from the journal itself). I wonder how much further the research has moved on.
The latest presentation on the LCTX website shows improved visual acuity for one of the OpRegen patients. https://investor.lineagecell.com/static-files/357f7a75-1dcd-455c-8824-c304c5a02f8e
(page 17).
It shows the number of letters read by the treated eye between 20-30 letters which equates to between 20/30 and 20/25. I think we haven't seen as much detail as before. This is one patient from the most recent cohort who were 20/64 and worse.
The untreated eye is showing no letters recognised, which equates to 20/200+
This is one patient. The length of data (9 months) shows it was one of the first in cohort 4.
So, there are signs that it works to some degree in some patients. I hope they present this data at AAO in October.
I'm left wondering how many years of safety data they need before they can sell something that works.
My understanding of the progress so far and the plans for the future.
By the end of June this year (2019) they should have concluded all tests so they can proceed to commercialisation.
Reimbursement won't happen until insurance companies see studies showing that it made sense to test with OCX instead of doing a biopsy.
At an OCX presentation earlier in the year they said that they expect some insurance support by the middle of 2020. At the presentation yesterday they said the maximum number of sales reps they would have would be about 40 by 2021. That looks as though they expect to show that the tests save money/ less intrusive by this time and the effort is to get physicians and patients to request the test thru insurance.
It's not clear to me how the progress for the next year will actually work.
If I have a suspected lung cancer, will my Dr say "do you want a potentially dangerous lung biopsy for free or pay 3000 dollars for a test"?
If the tests work will the insurance companies be eager to get a fast adoption or do they make more money when the diagnosis is expensive?
Well, something they own 1/3 of announced positive news. This is not hugely different from BTX announcing positive news. The only difference is the amount of control BTX have over OCX and I expect both entities to be trying to make money.
The rise is likely due to the good news from Oncocyte. Yesterday OCX was worth about 75 mn, today 215 mn. So BTX share of that is worth 75 mn today versus 25 mn yesterday.
The current report filing gives some indication of OpRegen efficacy. This is posted under the new section today (12/19/2018)
On December 17, 2018 our Board of Directors, determined that BioTime had achieved the following two OpRegen® related milestone performance-based vesting events, (a) 25% will vest if OpRegen interim functional data is obtained from at least five patients; and (b) 25% will vest if the OpRegen interim functional data is recognized by certain industry thought leaders as an early indication of treatment effect, with the Board using the following criteria as a guide to determine if this milestone is met, (i) Primary: OCT Images showing Ellipsoidal zone recovery, and signs of Improving RPE layer by autofluorescence, and (ii) Secondary: Microperimetry/reading speed/low light reading.
As a result, 50% of the restricted stock units (RSU) of the incentive grant awarded on May 24, 2018 vested on December 18, 2018, as to the individuals in the amounts set forth below in the following table:
Russel Skibsted and Stephana Patton.
I wonder who qualifies as an "industry thought leader".
It's not clear if both Primary and Secondary criteria are met. I imagine achieving the secondary criteria will catch more attention than the Primary.
The latest presentation shows some new (to us) information about the opregen success in RATS.
LD Micro Main Event XI Presentation (opens in adobe: it's on the BIOTime website.
On slide 13 it seems to show that the visual perception of the rats declines over time, but at a slower rate than the control subjects. This experiment rpe for dry and (science mag) shows the success of inserting an implant. Opregen works instead by injecting. It's not clear to me what are the advantages of our approach (perhaps cost).
Did you anyone see the AGEX shares appear in their brokerage account?
Oncocyte has posted a recent corporate presentation.
http://investors.oncocyte.com/~/media/Files/O/Oncocyte-IR/events-and-presentations/oncocyte-corporate-presentation-18-9-2018.pdf
While we have seen most of this information before, it does seem we're getting closer. This presentation says that all of the data should be in Q4 and then final commercialisation in H2-2019. It seems to me that they are showing their process works in this presentation. The testing now is to confirm officially that it works. If that is the case then we'll know in the next few months.
Yes, we have been here before a year ago when they found a problem with the consumables in the testing.
I'm hoping for
Renevia approval from Europe.
good feedback from the CA doctor (Gordon H. Sasaki,) who is trialling Renevia. He has said that he will be able to see the benefits of Premvia within 3 months.
good results from the opRegen trials with candidates whose eyesight is not too far gone.
The next few months could be interesting.
I'm in England and it's Miller time.
As I understand this: BTX shareholders already own AGEX (80%) and after the spinoff they will still own the same amount of AGEX, just that they will have shares in AGEX to the same value.
If market information was perfect then the value of BTX shares you own would go down by the same amount that the AGEX shares were worth.
One reason for splitting of AGEX must be to allow price discovery to function better. These actions are usually considered a success if splitting the parts leads to an overall higher valuation. I wonder what they will reveal when the AGEX shares become tradeable to help this happen.
There are historical precedents of new products entering the facial filler cosmetic market. The growth of product revenue after acceptability must be some function of cost, desirability, marketing to consumers and marketing to professionals who administer the product.
There are people on the board who have experience growing product sales. They must have some kind of models showing potential market share and profits depending on decisions they take bringing the product to market.
At the moment it feels like a "if you build it, they will come" product. I'm looking forward to the European CE mark approval. (I see this as a "it's recognised as safe" event). After this happens I hope the board can share their vision on market growth and profits.
BIOTime announced they were applying for the European license on March 13 2018.
http://investor.biotimeinc.com/phoenix.zhtml?c=83805&p=irol-newsArticle&ID=2337771
In that announcement they say the facial aesthetics market is circa 5$bn. 5 times more than the estimate I used.
At a recent conference call Michael did ask the finance guys asking questions, how they would value the company.
If the market that Renevia addresses is circa 1bn, and BTX get 20% of that and make 15% profit that makes 30 million. A P/E value of 15 on that is 450 mn which is comfortably more than the shares value.
At the IFATS conference late last year, someone who attended, said that the Renevia results from Europe matched the results from the USA. So they have a "product" that lasts twice as long and is more natural.
Obviously that hasn't all happened yet. It's not clear how quickly that product will go from "being available" to "being widely used". I'm expecting that will start happening towards the end of this year.
I'm prepared to be speculative with some of the other potential products from BTX because of this less speculative product. Will the market generally wait for greater revenue visibility, actual revenue, or will something else unexpected happen.
All IMHO. I'm not an adviser, don't play one on tv, nor slept at a Holiday Inn last night.
Patrick Cox, who has a free report at MauldinEconomics.com, was at the WSCS last week. He seemed to think Michael West's presentation was exciting. This could just be good publicity for AGEX. At some point in the future they have to start earning some money. I hope they can retain investors interest until that happens.
I didn't see this on the BIOTime website.
World Stem Cell Summit on Jan 25
Stem cell innovations that will change the world – Part 2
“The anti-aging potential of high-purity lineage-committed stem cells”
Speakers:
Jyothi Devakumar, PhD
Michael D. West, PhD
CEO, AgeX Therapeutics and BioTime
Chair: Aubrey de Grey, PhD
AgeX Therapeutics and SENS Research Foundation
http://www.worldstemcellsummit.com/sessions/stem-cell-innovations-that-will-change-the-world-part-2/
Terry, that's pretty much what I was looking for. Thanks for the information.
Terry, that's pretty much what I was looking for. Thanks for the information.
What was the IFATS data.
It's a little frustrating that there's no information I can find about the data presented to IFATS. My understanding is that Ramon Lull injected more of the "product" than the tests in the USA.
The company talks about licensing Renevia in Europe before America and also as a cosmetic solution versus just fat loss. So the info from Ramon would be doubly interesting. It's also about 6 months since he started the trial so his information should have been interesting.
The IFATS data could have been disappointing, in which case I feel that information would have become known in the wider arena. The data could have exceeded expectations, in which case that would also have been known. I know nothing so I'm expecting that it was inline with expectations. If that's the case I would still have expected some kind of excitement about the data, unless there are many other competing technologies and Renevia is just a "me too".
I'm a long term holder in these shares.