Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
BioTime, Inc. has added a news release to its Investor Relations website.
Title: Positive Early Data From BioTime's Renevia Pivotal Trial Presented at IFATS Meeting
Date(s): 18-Nov-2016 3:01 AM
For a complete listing of our news releases, please click here
-3D-imaging Suggests Grafts Retained Volume Over the Assessment Period-
-Cells Remained Viable and Proliferated in Renevia Hydrogel-
ALAMEDA, Calif.--(BUSINESS WIRE)--Nov. 18, 2016-- BioTime, Inc. (NYSE MKT: BTX), a clinical-stage biotechnology company with a focus on pluripotent cell-based technologies, announced details of positive data from its Renevia® pivotal trial, reported via a presentation at the 14th annual International Federation for Adipose Therapeutics and Science meeting (IFATS) on Thursday, November 17, in San Diego. The presentation was based on data from the "run-in," testing sample subjects to the European pivotal trial.
The presentation, titled "Stromal Cell-Hydrogel Construct Possibly Generates Clinically Relevant Neo-Tissue In Facial HIV-Lipoatrophy Pivotal Multicenter Clinical Trial: Early Analysis On Testing Patient Sample," was given by Ramon Llull, M.D., Ph.D., director of the Stem Europe Mallorca Center, in Spain, and the principal investigator of the trial.
Highlights of the presentation included:
Adipose progenitor cells (fat cells) obtained from a liposuction aspirate remained viable and were observed to proliferate when combined with the Renevia hydrogel
The Renevia gel and progenitor cells were successfully administered in the run-in subjects with no serious adverse events
3D-image analysis suggests that the grafts retained volume over the assessment period, and the treating physician-observed incremental volume was retained in select patients who had progressed to the one-year follow-up evaluation
"We are encouraged that the administration of Renevia worked well in these patients," commented Dr. Llull. "Existing methods used to address HIV and age-related facial volume loss provide only temporary solutions. We are seeing signs indicating that Renevia may be able to generate new facial tissue which could result in more natural, longer-lasting outcomes."
Developed as an alternative for whole adipose tissue fat transfer procedures, Renevia is designed to mimic the naturally-occuring extracellular matrix and provide a 3-D scaffold that enables effective cell transplant and engraftment. In the run-in portion of this trial, the Renevia administration procedure was found to be reproducible, and the pivotal trial is now into its controlled phase. Encouraging signs of Renevia being able to promote new tissue generation were seen with the run-in practice patients. If the pivotal trial is successful, the company plans to file the data as the basis for the issuance of CE marking for European use. CE marking is anticipated as early as the second half of 2017.
And they are trying anything that might give investors hope. The 10X fund is imploding on this massive bust.
Slowdown in deployment (total CaD value) per recent update, is not good news, in general. In fact it's bad news.
The thesis heart (at least the unproven parts thereof) is that the farmers welcome and use the new financing method in an ever growing rate.
While no. Of contracts grow (great for diversification purposes), additional sales team could not bring results yet.
For 2017 deployment year INP, Brad, and co. Are under the microscope.
Without good signs of market adoption, shown in growing book and MTon Canola on the balance sheet, this is just a small Mom & Pop business with too expensive management.
Everything is ready.
Can INP perform?
Time will tell.
Long.
BTX.WS expire in October of 2018 and have a $5.00 exercise price.
Scroll back to a discussion on the warrants. At these prices better to own the equity with infinity of free time value.
2018 FY is going to be the very early beginning of revenues from the subsidiaries proving the value of the platform and IP.
Then, the future is pretty limitless.
I want to see the blood tests. There was a hint of change in C. 3 of P. 1 - seen in the blood work (a2-macroglobulin). We have NOT seen the apples to apples comparables to have an opinion.
I agree with the sentiment that all rests now on Cx results.
at least financing is not going to dry out before the results.
Not selling (at minimum Ill have some tax loss harvesting for 2018).
enjoy the roller coaster today.
So now we are 100% streaming business. Next Qs we will have a growing streaming business reports, and then the market is going to award proper multiples.
Very quiet and very under the radar.
Just the way I like it!
I hope for this guy who shorted at 4$, he closed his short, cause we are at 7.5$.
It's dangerous to short what you don't understand.
Galectin Therapeutics Announces That Oral Treatment With Galectin-3 Inhibitor GR-MD-02 is Efficacious in Preclinical Model of Fatty Liver Disease With Fibrosis
NORCROSS, Ga., June 23, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that a preclinical study in a mouse model of NASH (non-alcoholic steatohepatitis, or fatty liver disease) demonstrated that oral administration of the Company's lead galectin-3 inhibitor, GR-MD-02, resulted in significant disease improvement.
http://investor.galectintherapeutics.com/releasedetail.cfm?ReleaseID=855926
:) You can not change compound mid clinical testing. That would necessitate whole new phase I...
It's fair to say we are all optimistic here, though going into the result be prepared for serious capital shredding if the results are not good.
Buy some puts if you don't have a good idea how to harvest the potential losses.
They are 2020. So I would think the Fx results will determine conversion, if shares drop following subpar results, the price drops and the situation becomes rather more complex. If the price stays above 2.5 we will see execution.
Perhaps these warrants can explain the very large volume without higher highs, considering the limited float.
Thanks Biotech. I wasnt taking into account the 2.5$ warrants. Only remembered the higher priced warrants. Good catch and potentially great source of funds. What is their duration?
No.
The main issue with management is their flub with changing the p1 measurements mid cohorts making apples to apples comparison impossible, while building hype and inviting the market to deduce efficacy from results.
Then, the (worst) results, which couldn't be compared to earlier results (shorter period), got the market to bet negatively on the compound, quite logically, and the regular Bears had a feast.
Then, instead of taking responsibility for the lack of visibility, management kept on blaming Shorters. And never owned up to their mistakes.
The science never changed and correctly with Psoriasis results no more funds were allocated.
Right now cash is running out, and it's a race between cash burn and positive results from Fx that might rehabilitate the markets perceptions about risk and probability for success.
CEO is in the bunker and not responding to shareholders questions right now. Much depends on Fx, for good or bad.
Recent days we have seen massive volume. I believe the short interest has declined substantially. With this volume many longs must have actually opted to trade out of the investment, which is interesting.
I would imagine many traders piled on waiting for imminent buyout and thus would imagine they will not remain long in GALT if results are anything but spectacular.
On another note, financing just got easier with the new volume and higher prices
A great company. Being a large BTX holder, I am watching closely, we own about half of the business. Seems like revenues in 2017, hopefully!
Indeed, if you are looking into this investment, the Call is a must.
What is intriguing is that there is Stem Cell fatigue with investors: so many failed clinically of diluted shareholders to oblivion very few bother to follow the sector.
The science is working out and the story is being derisked.
I believe that we are not very far from inflection point in public perception: Stem Cell therapy - validated in the clinic- is going to get high valuations.
Very very very good prelim efficacy news on OPC1.
Can't wait to see results on 20 mill cells.
This is nothing short of revolutionary for medicine.
I love it that the board is deserted. This little gem is undiscovered.
We saw that the Co estimated the TAM at 2bill. Pa, no competition. This is a 10 billion m. Cap on this indication alone.
Then, there are all the future uses of nerve cells in brain related issues.
The opportunity is SO LARGE it boggles the mind.
Still, the better position, risk adjusted is BTX the mother ship.
Who knows. It's trading on HUGE volume since the word came out, and already ~30% up. I wonder who is selling.
There is still long way to go, but I believe 2017 will be the year where the true value of the mother company will emerge.
So many things going on
He started feeling his legs and they started moving. This Trial is about making Science fiction into practical medicine. look:
https://blog.cirm.ca.gov/2016/09/07/young-man-with-spinal-cord-injury-regains-use-of-hands-and-arms-after-stem-cell-therapy/
He is LIFTING WEIGHTS. 4 monts ago - paralysed.
Unbelievable news!!!
Dear BioTime Investor,
We have some encouraging news to share with you.
News that was released this morning by the University of Southern California offers hope to patients suffering from severe spinal cord injury. A team of doctors at USC are evaluating the safety and efficacy of AST-OPC1 as a therapy for spinal cord injuries. As reported, a paralyzed patient in the study regained the use of his arms and hands after treatment with AST-OPC1 in April. Asterias announced that it expects to report its interim efficacy data on September 14, during the 55th Annual Scientific Meeting of the International Spinal Cord Society (ISCoS), which is being held in Vienna, Austria.
This news is a big step forward and shows the power behind the “pluripotent” platform that BioTime and Asterias utilize for novel cell-based therapies. Restoring the level of function that could improve the neurological function and quality of life of patients with spinal cord injuries, is, we believe, just the start of what may be many important new therapies to come from this platform.
As we have said for some time, the power of pluripotent technology has the ability to provide a number of potential cell-based therapies. With this in mind, we remain strong believers in the Asterias team and its clinical pipeline.
Currently, BioTime holds approximately 48% or $61M of the outstanding common shares of Asterias Biotherapeutics (NYSE MKT: AST). Several news and media opportunities are expected on this news. Also, we expect future updates will be found on the USC media content center located at www.keckmedicine.org.
Here’s a link to all of the USC media, including the news release and b-roll:
http://www.keckmedicine.org/stem-cell-patient-media-assets/
This sends shivers down my spine. It's the same magnitude as the first landing on the moon for medicine:
Dear BioTime Investor,
We have some encouraging news to share with you.
News that was released this morning by the University of Southern California offers hope to patients suffering from severe spinal cord injury. A team of doctors at USC are evaluating the safety and efficacy of AST-OPC1 as a therapy for spinal cord injuries. As reported, a paralyzed patient in the study regained the use of his arms and hands after treatment with AST-OPC1 in April. Asterias announced that it expects to report its interim efficacy data on September 14, during the 55th Annual Scientific Meeting of the International Spinal Cord Society (ISCoS), which is being held in Vienna, Austria.
This news is a big step forward and shows the power behind the “pluripotent” platform that BioTime and Asterias utilize for novel cell-based therapies. Restoring the level of function that could improve the neurological function and quality of life of patients with spinal cord injuries, is, we believe, just the start of what may be many important new therapies to come from this platform.
As we have said for some time, the power of pluripotent technology has the ability to provide a number of potential cell-based therapies. With this in mind, we remain strong believers in the Asterias team and its clinical pipeline.
Currently, BioTime holds approximately 48% or $61M of the outstanding common shares of Asterias Biotherapeutics (NYSE MKT: AST). Several news and media opportunities are expected on this news. Also, we expect future updates will be found on the USC media content center located at www.keckmedicine.org.
Here’s a link to all of the USC media, including the news release and b-roll:
http://www.keckmedicine.org/stem-cell-patient-media-assets/
Met with management. Not a fan. Too many red flags popped up in deep DD.
Take notice: http://tinyurl.com/hyxwl9r
Insiders are financing this microcap and underlying companies. Directors are buying massive stock holding 750,000$ worth of units.
Financing terms are always very strong.
It may take some time to evolve, but this is going to be a very interesting business.
2017 is going to be very exciting as the first products hit the market.
http://tinyurl.com/hyxwl9r
Take notice, no one invests 750,000$ without high conviction his investment will pan out
New board member, from Asterias, buying 750,000$ stock. That is bullish.
That's actually very common mistake. The fact is that although it's closer to zero, you can actually lose everything via share drop and dilution. The initial "low" pps will not save ya.
Look at ISCO if you want an idea how bad it can get over time.
I actually expect fair results, but The position is sized per the risk.
Do your own DD.
Some weakness due to China demands to ship cleaner canola seed. Industry says too expensive and fears Canola prices might collapse as key buyer leaves the market.
Short term, prices are locked in.
Longer term effect on deployment rate and farmers reaction (willingness to receive INP Capital) unknown.
Someone once said that the best medicine against weak prices are weak prices. Markets correct itself.
Just be cognizant of the risk to get to zero.
They have nothing to lose. If poor results in Fx, it will prob. mean less chance the Cx is success in humans as animal model. It will not matter what they say or do - The retail base will be vomiting the stock. Prepare to nanocap status.
If Fx shows good results, the market will still be skeptical ( Fx is non. Registration trial) and response will be meh, as the balance sheet is weak, don't expect 5 billion cap on Fx alone. In this case, they will need to work on financing, and this event is in preparation, "pound the iron" when it's red hot. Hopefully, at better valuations.
Let's hope good results at least lift the stock back to 10$, prior to dilution.
I also tend to believe that much of the veteran retails want out, as it's been long road. Expect heavy selling pressure from 5$ on up.
Well, there IS a reason Clinical Trials are requisites. There IS a risk human Liver Fibrosis fails to heal on the same level of PreClinicals... If the results are not significant, watch out below.
It is hoped that Clinical Results are spectacular. But hope is far from certainty. Cash will not last for long pivots without massive dilution of trials fail to be very good.
That's the risk.
Let's hope it is worth while.
So, basically no additional response on P. from prolonging exposure, and at this regimen, too low response to be considered as viable treatment (although I would imagine some patients would like the lesser remedy at zero side effect, the biological have horrible s.e).
The PR was nicely spinned, and the market reacted like it should, we just lost a bunch of value priced for P. Drug.
Next stop is Sept., the dreaded top line for the short trial on Nash.
Prepare from some massive volatility, up or down, on results.
Long GALT.
btw, silence here suggests many gave up. My little position is a speculation long ago marked 0.
Very powerful move today. Someone getting a hint of Sept. Results from the short trial? Very peculiar.
The last issue with Input is how fast it can grow. Management told me its targeting 50 million dollar deployment this coming year. This is about 166 streams, and the company established a credit line for that purpose. Question is, will growth ramp up and to what type of run rate. If and when the growth rate picks us, hold on to your hat.
OMG. Are Isco Execs are starring in this Video??? LMHO
http://www.invest-owl.com/when-share-dilution-goes-wrong/
These guys nailed it - everything wrong with a company like this one!!
Must watch?
Because money won't last that far. All rests on the short test.
Or they worry the company winds up if September results are terrible and need more incentive to stick around until that time.
Just shows you the staff are not very optimistic or enthused about the prospects.
Not good.
Yawn. Is Tox done yet?
Anything else is just ... not that important.
It seems they are traveling backwards.
Long (very little though). I dont like the shorters here, but man, is my patience getting spread thin after so many years.
Without any substantial proof they can start P1 sometime in the next 10 months, I believe I will turn my back on this investment and would have to conclude, to my dismay, that the shorts had a point, and these guys are ... .
I just love trading BTX around 2.3$ to ~4$. Gives you great return while we wait for the business to mature and establish itself with a very long hold outlook.
Very very good news, and fortunately I managed to grab some seconds after news broke. Next up, rate of growth. The company still looks undervalued based on book value.
And still hold well over 3M shares. Immaterial.