Does anyone here know how Athersys has advanced their MultiStem IS treatment regimen to "a scalable off the shelf" product such that there is no danger of patient rejection, much like what Healios aims to do with their iPSC's using Universal Cell's proprietary technology? That is a parallel between Athersys and Universal Cells, Healios is onto this enormous game changing shift that will catapult them to a dominant first to market position in regenerative medicine.
The reason for my posting all this on the ATHX board is to underscore the brilliance of Healios, our partner. Their success will be a world first, and Athersys is right there, as Hardy said..."and this is a moment." This 'organ bud' technology will be of mind boggling importance to the world's patients, as will our MultiStem for IS, ARDS, and AMI.
Sentiment: Strong Buy
“iPSC regenerative medicine is our core business. When iPSC regenerative medicine with less risk of transplant rejection can be developed from iPS cells regardless of HLA type, safety of treatment is improved, and treatments for a variety of diseases can be developed. This technology enhances clinical application of iPS cell technology,” commented Dr. Hardy Kagimoto, President, representative director and CEO of Healios.
During the option period, Universal Cells will engineer Healios’ clinical-grade iPSCs. The exclusive option is for the treatment of dry/wet AMD, and for use with Healios’ proprietary Organ Bud technology in liver and kidney clinical fields."
Explaining perhaps another reason that Healios' stock price has more than doubled since February 12th is their collaboration with AThersys, and two months later with Universal Cells, a private company out of Seattle. Here's the PR:
"Universal Cells Inc. and Healios K.K. enter Collaborative Research Agreement with Exclusive Option to Produce Universal Donor iPSCs
April 6, 2016 (Seattle)－Universal Cells Inc. (Seattle WA, USA) and HEALIOS K.K. (“Healios”) (Tokyo, Japan) have entered into a collaborative research and exclusive option agreement to create therapeutic off-the-shelf iPSCs. The partnership will focus on the production of Universal Donor iPSCs by editing the genes required for antigen presentation.
“Partnering with the world’s leading company in iPSC therapeutics, and the leading nation for accelerated regulatory approval for regenerative medicine products is a significant step towards bringing universal donor cells into the clinic”, commented Dr. Mitchell, CEO of Universal Cells.
Universal Cells’ technology is based on discoveries by Dr. David Russell, the co-founder and Chief Scientific Officer of Universal Cells, and a world-renowned leader in gene editing. Universal Cells has licensed patents on recombinant adeno-associated viral (rAAV)-mediated gene editing, and HLA engineering.
With Universal Cells’ proprietary technology, Healios intends to develop next-generation allogeneic iPSCs that are compatible with everyone. Although autologous iPSC manufacturing is feasible, an off-the-shelf cell line has the potential to revolutionize the field of cell therapy by enabling the scalable production of safe, effective, and predictable treatments.
“iPSC regenerative medicine is our core business. When iPSC regenerative medicine with less risk of transplant rejection can be developed from iPS cells regardless of HLA type, safety of treatment is improved, and treatments for a variety of diseases can be developed. This technology enhances clinical application of
They did put another collaboration together with Universal Cell recently but I'll give you a clue, their stock on February 12th of this year was 915 JPY, now 100 days later it has more than doubled. Our partnership was early February, they filmed the R & D Partnership Day video on February 4th.
This stock at this point is dominated in daily trading by those traders who won't trust it for more than a few days. Rallies are quickly sold, like today from a morning high of .87 to a close of .73. I suspect it may be this way for a while until the Company can start building on their collaborations and until revenues can show up in sufficient quantity to offset the fear of capital depletion and more dilution. Aspire stock sales and recent offering can only carry them so far. The prospect of a larger buyout remains, but nothing inherent in that to sustain the stock price. I hold TROV as well, should have left this one alone in hindsight, but at this point, am going to ride it out and hope for the best. I like their execution, they just need to ramp this up faster.
When I posted this yesterday evening, it was their lunch break when they close the session for an hour. The afternoon it was a steady advance taking out the previous intra-day high of 2020, and making a new all time high, closing only two JPY shy of it. This was a breakout for sure, and for shareholders who bought the IPO in May 1, 2015, it represented an advance of 31.9% in the year since. Friday it was up over 7%, this Company is on the march, Athersys is in the spotlight for sure.
It's like the settling of the one lawsuit didn't even happen, other than being able to have a clear shot at marketing their product. Settlement, let's have something on that Keith!
1,964.00 JPY Price increase 106.00 (5.71%) today's high 2020.
You can find the stock price quickly by putting the thread heading into your search engine. The way they are moving, maybe we can get the same mojo going here?
I think shorter than three years, considering the overwhelmingly positive phase 2 trial results after 12 months, to reach excellent outcome measure across the trial participants. I don't think the FDA will require any longer study than the previous trial, especially given the safety profile. We could get provisional approval in Japan following interim results if they are good enough. We should get an update by the annual meeting on the trial design likely timeline to (trial design) approval and first dosing. Nothing can be concluded, management needs to give their guidance on this, we are just guessing. And yes, Gil mentioned leveraging the US and EU approvals on what they're doing in Japan, how could it not accelerate our path?
Very astute Gibis. They don't presently have the wherewithal to go global on our highest percentage pipeline candidates, so perhaps the second tier programs as you suggest? Meanwhile, they should limit their resources to supporting what we can do together in Japan, and they are in a great position to execute with us being the esteemed Japanese partner that our management has acknowledged as being a great fit. They are very ambitious, talk the same language, and are ever so confident as to the prospects for what they've seen and partnered.
I'd like to see you weigh in on my timelines post "Coming to Clarity...". We don't know and can only guess at what will happen, but we have some very astute longs here, who can make some educated observations as to approval likelihoods, and eventual commercialization of IS in Japan, with some revenue projections and timing of same.
Do we really have several more years ahead of substantial losses before we achieve profitability as the 10K says on page 40, under Results of Operations, and I quote: "We expect to continue to incur substantial losses through at least the next several years." I have been discounting that statement, based on what progress we've recently made, with most of our trials being either partnered or grant supported. Anyway, enough said, thanks for your post.
Since this thread was first posted, the 10K Annual report has been published and disseminated. On page 39, under Financial, "In connection with ourJanuary2016 license agreement with Healios...If Healios expands the collaboration, we will be entitled to receive an additional cash payment of $10 million. Healios may exercise its option to expand the collaboration y the date that is later of (i) December 31, 2016 and (ii) the receipt of the initial results from Athersys' ongoing ARDS clinical trial."
Gil obviously knew this when he made the other statements implying the expansion of the Healios collaboration was more emminent. What he wants to take place sooner he was speaking optimistically while he called attention to the dates and trial results Healios likely would require seeing first before they decide. We likely won't have this as our next catalyst. These are the kind of statements intended to keep shorts from getting too comfortable, because it really could happen at any time.
Sentiment: Strong Buy
Today is going to mark the turning point in our weekly chart, from the slow drip down, to a melt up into our next catalyst (which likely will be Healios' submittal of the J-IND for IS). Wednesday's price action was the positive signal I needed to see this coming. Hopefully we'll learn in the not too distant future when we can anticipate Healios submitting the IS trial plan to the PMDA.
It is precisely this technical action in our price that I look for when my confidence increases to optimally add to my position. I added 5,000 shares already today, half at 2.17 and half at 2.23. After four red candles on the weekly chart, this week is going to be white, marking the turn. GLAL
Sentiment: Strong Buy
Our illustrious team at Athersys might know if these are posted somewhere, call the Company if all else fails. Still can't understand why they don't let investors in on their schedule for these conferences and actually make them available.
Trial design submittal, I would hope that since Gil said they had reached agreement on most elements of the trial design that the J-IND and trial design could be submitted together. He said they had anticipated that these might be the last meetings with PMDA before they submitted, but then he went into the discussion over the larger international trial and left no more clues.
Get an account open at stockchartsDOTcom and start consuming their chartschool section, also watch their seminars and listen to the market message where they do live annotations.
Futures are currently up, the stars are aligning. Many think TA is akin to astrology, so this analogy may placate that crowd. I am greatly entertained by charts, and the uncanny patterns that develop over time. They allow for predictive analysis, great to help judge best times to enter or close a position. GL
Sentiment: Strong Buy
Awesome insight, they were up 128 or 7.43% today to 1850. Japan gets it where MAPC and iPS cellular therapies are embraced. MultiStem isn't the norm, it's the gold standard, what a safety profile. Do you have opinion on timelines as I posted in thread "coming to clarity"?
Absolutely agree with you. Not worried, just watching the gyrations and emotions as we chill. Missling has his ducks in a row, he's a very astute CEO, especially after the market played the stock last November and ever since. He won't let that happen again, this time it will be bear proofed.