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Athersys, Inc. (ATHX)

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  • L
    Left-e
    $MESO conversation
    @CavScout, $ATHX We have it in black and white in the Khan and Newsome paper that MAPC's meet ISCT criteria to be classified as MSC's. I'll take the word of two experts in cell biology over your old post my friend, LOL. I think what potentially misleads is failure to realize that MSC's are also “multi-potent”, able to differentiate into epithelial, endothelial and multiple stromal tissues in between. I suspect MAPC's are a subset of MSC's and the experts will sort that out at the appropriate time – when there's an actual product available for commercialization and analysis. Notice that all competing companies in this sector carefully avoid using the term “mesenchymal”. Pluristem does the same thing. I think it potentially misleads investors, which is why I keep pointing it out.

    The deal with Novartis was announced last November. It's to develop remestemcel-L for pulmonary applications and it has a potential value in excess of $1B. You're right, it hasn't closed yet as NVS analyzes data from the ARDS trial released 2 and a half months ago. So, we don't yet know how that will turn out. But what we do know is that a deal was signed and announced to the public. And before signing such a deal we can be sure that Novartis executives surveyed the field of competitors, Novartis scientists evaluated the technology and Novartis lawyers carefully examined the patents. And unforced, Novartis chose Mesoblast.

    Regarding ARDS, maybe you can elucidate the “differences” for us? I suspect the decision to modify Macovia was driven more by economics than etiology. As an investor what I see at Athersys is a company treading water, still searching for dose, trying to find a partner, short on capital and not leading the field. Macovia is trying to recruit 400 ARDS patients drip-drop at 4 centers in a narrow region of the country. That will take years. It's not the big national or international phase 3 trial you'd expect from a leader. And whatever it shows will require a follow on large pivotal trial. After 6+ years of effort, $ATHX investors today July 18, 2021 can base their assessment on precisely 30 cases reported in the Mustards trial in 2019. And that trial would not have met the high bar primary end-point set by Mesoblast, despite drawing from an “easier-to-treat” population of all-cause ARDS (40% mortality in Mustards controls compared to 53.3% mortality in the Mesoblast control group). At least the phase 2 portion of Mustards was blinded and randomized, which will not be the case with the open-label study pending in Japan. Still, as I mentioned earlier, Japan is shaping up to be a showdown situation. Why the delay in reporting data by Healios? Will Mesoblast that has an MSC licensee in Japan allow a new competitor to enter the market? Some of the questions raised in our discussions could get answered shortly. Meanwhile, investors should also note that having a partner actively treating cases in Japan apparently holds little sway with the FDA, at least in the case of children suffering a 70% mortality rate from aGvHD secondary to leukemia treatment.
  • M
    MH
    If you check out the detailed description on the clinical trials website, you will see that biomarkers are measured at treatment and 180 days after for both pneumonia based ARDS and covid patients.

    In the outcome measures portion, it contradicts itself with Covid-only statements.

    It makes sense with an investigational drug, especially stem cell based, to check blood counts before, during, and after treatment to reassure safety.

    So, I agree, 180 days after the last patient was treated, which was in March, is when they will decipher the data and release it several weeks later, which will be the 1st or 2nd quarter 2022.
  • L
    Left-e
    $MESO conversation
    @CavScout, Yes, I've read the paper you cite. And I agree Japan may become a showdown country if $ATHX partner Healios indeed posts positive results...

    Patents are a complex area so don't get too sure of yourself. Whether you're right or I'm right, investors should be aware of some historical precedents that are easy to research. Most recently, Tigenix/Takeda made very similar arguments to yours when they first developed their injectable stem cell product for treatment of Crohn's perianal fistulae. Our product is “different”. It comes from adipose tissue not bone marrow. We prepare the cells differently. The cells don't have the same phenotype, etc, etc. Then the final product was analyzed and the lawyers sat down. Now enter this search term into your browser: “Takeda to pay Mesoblast license fee”. That will take you to a “Patent License and Settlement Agreement” filed with the SEC in 2017. It details the 20M Euro license fee and royalties Takeda paid and pays to Mesoblast for use of their cells in a very narrow indication, excuse the pun, much narrower than ARDS. If you go back further still, and since you mention Osiris, you'll find that Mesoblast purchased Osiris' MSC product, perhaps to get the patents after losing... I'll let you research it. In fact, irony of ironies, go back further still and you'll find a small percentage of all royalties still flow to CWR and Dr Arnold Caplin, the “Father of Stem Cells” right there in Cleveland. Full circle.

    Of course natural products can't be patented. But the adhesion techniques/processes of separating out cells and then expanding them can be. I believe the question will ultimately come down to whether MAPC's are “mesenchymal”. Phenotype and function don't count unless they're so primitive as to have hematopoietic potential, which I doubt. The authors describe them as “stromal” cells and another name for Mesenchymal stem cells is Mesenchymal stromal cells. They behave like MSC's in terms of MoA, as detailed in the white paper, and they meet the ISCT definition of MSC.

    Mesoblast has over 1000 patents, some of them foundational in the industry and now extended to the year 2040. The CEO, SI, has indicated that licenses may be issued to companies developing cells for indications that don't conflict with indications under development by Mesoblast. Mesoblast already has a licensee in Japan, JCR pharmaceutical, which commercializes an MSC product called Temcell. But JCR is dedicated to orphan indications and has said they're not going to pursue ARDS. Does that mean the Japan market is open? A highly reliable poster on HC has said Mesoblast plans to block any cell therapy competitors in ARDS. We're waiting to see if deep-pocket patent-enforcing Novartis might get involved. The fact alone that Novartis signed a contract with Mesoblast to develop MSC's for pulmonary indications says a lot, even if it hasn't yet closed. So, a lot of variables and moving parts. No one can say, perhaps not even ATHX management, until there's a final product that's ready for commercialization and it gets analyzed and the lawyers sit down. So, let's see what happens – it's moot and undetermined until Healios gets a product over the goal line and starts commercializing.

    Meanwhile, Mesoblast has controlled, blinded data on 222 C-19 ARDS patients plus another dozen EAP patients. They've released data on all those cases since first getting involved in this area in March 2020, just 16 months ago. And they have a signed contract with a global partner, Novartis, waiting for closing. Athersys has been working on ARDS since 2015. During that time they've reported on 30 MUSTARDS cases. Healios, busy since January 2019, may add another 35 cases. Who knows how many Macovia cases or any interim results there? No matter what happens in Japan, I would submit that's an abysmal, tell-tale record for Athersys who indeed should be the leader in ARDS. But is not.
  • y
    yags_2001
    (Updated) Lets break it down peeps!........

    March 31, 2021: ATHX announces that Healios announces it has completed enrollment of 1-Bridge trial;

    April 28, 2021: Last patient enrolled has completed the post 28 day evaluation of days on a ventilator;

    May 6, 2021: 2021 1st Qtr CC: (Day 36) B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

    "First, thank you to all of you who have submitted questions. I'm going to address a few of these here. The first question is about the timing of data from the Japanese studies, in particular, the ONE-BRIDGE study for ARDS and the TREASURE study for ischemic stroke.

    As I noted before, Healios has announced the completion of enrollment into ONE-BRIDGE study. With respect to the top-line results, Healios controls the timing and nature of any public disclosure, which will depend on the completion of the analysis of the study data. Typically, in such ARDS studies, the first 60 days following treatment represent a core window for patient data collection. So with this in mind, we hope that we'll see the top-line results available relatively soon."

    July 22, 2021: Still waiting to hear the results 85 days since there is nothing else to evaluate...... : (

    so here we are.......LIMBO LAND.....otherwise known as Hardyville.........I will fill in the blanks as some "things" have happened in these 85 days of the hostage crisis......
  • y
    yags_2001
    (Update: Day 88 Stockholder Hostage Crisis)

    Lets break it down peeps!........

    March 31, 2021: ATHX announces that Healios announces it has completed enrollment of 1-Bridge trial;

    April 28, 2021: Last patient enrolled has completed the post 28 day evaluation of days on a ventilator;

    May 6, 2021: 2021 1st Qtr CC: (Day 36) B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

    "First, thank you to all of you who have submitted questions. I'm going to address a few of these here. The first question is about the timing of data from the Japanese studies, in particular, the ONE-BRIDGE study for ARDS and the TREASURE study for ischemic stroke.

    As I noted before, Healios has announced the completion of enrollment into ONE-BRIDGE study. With respect to the top-line results, Healios controls the timing and nature of any public disclosure, which will depend on the completion of the analysis of the study data. Typically, in such ARDS studies, the first 60 days following treatment represent a core window for patient data collection. So with this in mind, we hope that we'll see the top-line results available relatively soon."

    June 2, 2021: (Day 63) Form 4 filed for J.J. Harrington planned sale of 20,447 on 5/28(20247) & 6/1 (200) $1.75/share

    June 8, 2021: (Day 63) Form 4 filed for J.J. Harrington planned sale of 27,107 on 6/8 for $1.75/share

    June 15, 2021: (Day 70) Form 4 filed for Shah Baiju R awarded 50,000 Stock Options @ $1.54 strike price

    July 24, 2021: Still waiting to hear the results 88 days since there is nothing else to evaluate...... : (

    so here we are.......LIMBO LAND.....otherwise known as Hardyville.........I will fill in the blanks as some "things" have happened in these 88 days of the hostage crisis......
    Bullish
  • L
    Left-e
    $MESO conversation
    @CavScout, Your posts on the MESO board are pretty rich given that $ATHX notched a new 52-week low just this morning at $1.36. It's been knocking at the door in the floor on multiple occasions over the past two weeks – as you well know. Probably due to $ATHX management pinging the ATM, their best chance to raise badly-needed capital. But today they overshot by a penny, though the session is not yet over.

    Pete Petite is going to jail because of low-life business practices, among them he overstated revenues. One way was by stuffing inventory into customer and other warehouses and calling it “sales”, a well-known trickster technique. Since, the main source of ATHX revenue is the coffeepot in the employee lounge, no one is accusing them of that problem – though you'll recall that IR exaggerated on numerous occasions last year that management was busy transitioning the company to “commercial stage”, a hoot. But there are other issues with ATHX. One is that no independent source, no independent academic, quite has a handle on exactly what are MAPC's – and the recent white paper labelling them as “stromal” cells doesn't help much. No one else is working with them and not even the Chinese are trying to copy them. Given that the ISCT classifies MAPC's as “mesenchymal” it could be a problem if they turn out to be something like... oh, I don't know, something like Mesoblast's MPC's, the preparation of which Is protected by foundational patents. To the extent they're even more primitive than mesenchymal, as the label “multipotent” and the eye-popping doses needed to treat imply, there will still be batch consistency/MoA issues in getting them all to differentiate the same and do some therapeutic work. A second issue - ATHX management is very tight-lipped about their trials. No EAP's. No enrollment status reports. No interim checkpoint DSMB reports... or maybe they just haven't gotten to an interim checkpoint yet. There's been essentially nothing since 20 patients treated in the MUSTARDS trial were reported in 2019, over 2 years ago. Meanwhile, a third issue, despite slow walking the trials, ATHX management loves their 10b5-1 plan. No delays there as management unloads newly printed shares to people like you every quarter and pockets the proceeds. And the founding CEO who was “forced out”, LOL, is now free to unload his millions of shares without the inconvenience of reporting on a Form 4, On his departure remaining management awarded themselves huge “retention” bonuses, just in case the company can't find replacements to manage the commercial stage coffeepot revenues. As that plays out, fourth issue, the company and its shareholders have placed their immediate fate in the hands of a Japanese company running open-label phase 2 trials where patients are cherry-picked by definition. There are all sorts of conflicts of interest, and after a full 2 ½ years to test just 35 patients with ARDS, you all are still waiting for “results” that can have no statistical significance since not blinded or randomized. It means ATHX is now years behind MESO in the market for a cell-based therapy to treat ARDS.

    Yet you persist in pumping ATHX on the MESO board without a blush. It's enough to make us all wonder why you dropped the word “clown” from your handle. Did the clown lobby get after you for defamation?? LOL
  • y
    yags_2001
    (Update: Day 86 Stockholder Hostage Crisis)

    Lets break it down peeps!........

    March 31, 2021: ATHX announces that Healios announces it has completed enrollment of 1-Bridge trial;

    April 28, 2021: Last patient enrolled has completed the post 28 day evaluation of days on a ventilator;

    May 6, 2021: 2021 1st Qtr CC: (Day 36) B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

    "First, thank you to all of you who have submitted questions. I'm going to address a few of these here. The first question is about the timing of data from the Japanese studies, in particular, the ONE-BRIDGE study for ARDS and the TREASURE study for ischemic stroke.

    As I noted before, Healios has announced the completion of enrollment into ONE-BRIDGE study. With respect to the top-line results, Healios controls the timing and nature of any public disclosure, which will depend on the completion of the analysis of the study data. Typically, in such ARDS studies, the first 60 days following treatment represent a core window for patient data collection. So with this in mind, we hope that we'll see the top-line results available relatively soon."

    June 2, 2021: (Day 63) Form 4 filed for J.J. Harrington planned sale of 20,447 on 5/28(20247) & 6/1 (200) $1.75/share

    July 23, 2021: Still waiting to hear the results 86 days since there is nothing else to evaluate...... : (

    so here we are.......LIMBO LAND.....otherwise known as Hardyville.........I will fill in the blanks as some "things" have happened in these 86 days of the hostage crisis......
    Bullish
  • y
    yags_2001
    (Update: Day 87 Stockholder Hostage Crisis)

    Lets break it down peeps!........

    March 31, 2021: ATHX announces that Healios announces it has completed enrollment of 1-Bridge trial;

    April 28, 2021: Last patient enrolled has completed the post 28 day evaluation of days on a ventilator;

    May 6, 2021: 2021 1st Qtr CC: (Day 36) B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

    "First, thank you to all of you who have submitted questions. I'm going to address a few of these here. The first question is about the timing of data from the Japanese studies, in particular, the ONE-BRIDGE study for ARDS and the TREASURE study for ischemic stroke.

    As I noted before, Healios has announced the completion of enrollment into ONE-BRIDGE study. With respect to the top-line results, Healios controls the timing and nature of any public disclosure, which will depend on the completion of the analysis of the study data. Typically, in such ARDS studies, the first 60 days following treatment represent a core window for patient data collection. So with this in mind, we hope that we'll see the top-line results available relatively soon."

    June 2, 2021: (Day 63) Form 4 filed for J.J. Harrington planned sale of 20,447 on 5/28(20247) & 6/1 (200) $1.75/share

    June 8, 2021: (Day 63) Form 4 filed for J.J. Harrington planned sale of 27,107 on 6/8 for $1.75/share

    July 24, 2021: Still waiting to hear the results 87 days since there is nothing else to evaluate...... : (

    so here we are.......LIMBO LAND.....otherwise known as Hardyville.........I will fill in the blanks as some "things" have happened in these 87 days of the hostage crisis......
  • M
    Matt
    Check the chart, this stock can be driven. Over the past 12 years, like clockwork, the stock has taken a dive to these levels < $1.40 and then popped up over $2. Rinse and repeat, typically in less than 12 months. It's been below $2 for 3 months already now. Within the next 9 months, a pop to $2 is a 43% return.

    I'm not expecting big things, just the same old as the past 12 years. $1.30 => $2+. Back to $1.30 => $2+. I'm just going to buy a couple thousand shares and put in my GTC at $2.25, check my account for the cash proceeds a year from now!
  • d
    divan
    Please look at the latest post in Athersys FB page. It may be a hint of something big happening. I could not post the content or link .
    Bullish
  • L
    LongStock
    The judge told Petit that "he is used to seeing crocodile tears and sorry just means I'm sorry I got caught". Petite's lawyer asked for 1 year and 1 day time off for good behavior and the judge said "no". You are going to spend 1 year in jail. Read the sentencing transcript, Petit said he'd do charity consulting work; it's like reading a comic book. These guys think they can get away with just house arrest and an ankle bracelet.

    CavBoy, You're "insider" friends better take some notes and you could use a little schooling too.
  • L
    LongStock
    The former CEO of MDXG, Parker "Pete" Petit, starts serving his one year prison sentence for fraud on September 21, 2021. The judge insisted that he serve some real prison time in addition to his SEC fines and the company claw back of his $12 million bonus.

    ATHX is within pennies of its 52 week low. The execs at ATHX better take note of where Petit is ending up for making the books look too bright.
  • y
    yags_2001
    I have to say it is impressive with the stall and delay tactics here.....no exactly sure the purpose of it, but whatever, I'll continue to play along since, well, there isn't much of a choice in the matter......what seems like a 1st quarter 2021 to at the latest 2nd quarter 2021 game changing news has now turned into some kind of 2022 black hole.....LOL!.......so hats off to Hardy and his conspirers in whatever it is the their grand plans were for getting this going.......raising capital.......at $1.50 per share? Ok....whatever........prepare for another uneventful gaslighting CC on August 9th....oh how I love these people........masterful to say the least and they even got rid of the Master gaslighter, Gil himself.......wonder how that manufacturing facility is coming along in Stow Ohio.....might be taking a road trip there in a few weeks to check it out....will report back if I see any signs of life.......or Gil for that matter.....
  • C
    CavScout1969
    One point BJ made on the last call, “Typically, in such ARDS studies, the first 60 days following treatment represent a core window for patient data collection.” I was also previously told by the company that it would be around 6 weeks to validate and analyze the data. With that said, we are 5 weeks past the 60-day mark today. So, even though they definitely have the 28-day POM data fully analyzed, it’s one more week until the 60-day data is at that magic 6 week mark. Lots of speculation here but we’ll see…
    Bullish
  • y
    yags_2001
    Lets break it down peeps!........

    March 31, 2021: ATHX announces that Healios announces it has completed enrollment of 1-Bridge trial;

    April 28, 2021: Last patient enrolled has completed the post 28 day evaluation of days on a ventilator;

    July 21, 2021: Still waiting to hear the results 84 days since there is nothing else to evaluate...... : (

    so here we are.......LIMBO LAND.....otherwise known as Hardyville.........I will fill in the blanks as some "things" have happened in these 84 days of the hostage crisis......
    Bullish
  • C
    CavScout1969
    $MESO has dropped on heavy volume with each and every binary event over the last nine or so months.

    On the contrary, $ATHX drifts lower on average to below average volume. This is all while we wait for the outcomes to go public. Now if the outcomes are released and the price continues to drop (like MESO), then you guys can have at it. Until then, your points are moot. Pretty standard stuff here folks. We’re all just here waiting for the upcoming Healios ARDS data and announcement of their marketing application for general ARDS from all causes (as Hardy recently stated).

    Apples and oranges, you know it and I know it.

    Enjoy your weekend. I will. 😎
  • e
    edf
    slowly she turns step by step...
  • g
    guy
    all covid related stocks soar today..i thought athx would too i guess we are not covid related.
    Neutral
  • R
    RidgebackBoo
    Glad I bought more ATHX for $1.39, $1.38, $1.37, and $1.36 the past few days........