I highly recommend listening to last night's MESO conference call. I find it amazing how fast they have moved and how they are recruiting in 30 centers. They expect interim data in just 2 months on the first 90-100 patients At this point the the trial may be stopped for either futility or efficacy If it is stopped for efficacy, you can bet they will get Emergency Use Authorization. Still puzzling how an Australian company has managed to move so fast and starting with just a small compassionate use study seems to have been the key.
@RealNiceKeith replies:No the key is that they have Remstemcel late stage safety data (to satisfy safety requirements of regulators) and can piggyback off of ATHX’s ARDS data to jump right into a pivotal trial for COVID with confidence. They are also using a clinical trials network (Cardiotoracic Surgical Trials Network) that I believe has allowed them to already begin recruitment at a large percentage of the 30 centers. Why doesn’t ATHX use a similar clinical trials network to set up site recruitment in a similar fashion, for ARDS and other indications such as Stroke? According to clinicaltrials.gov ATHX has only 9 US sites enrolling for MASTERS-2, which began in July 2018. Mesoblast already has at least 12 sites recruiting for COVID and their trial was initiated in late April 2020!
@wall_street_titan replies:Athersys has a completed Phase II ARDS study with 1 year data. Mesoblast had no data on ARDS. I get your point on Phase III safety data though. It is rare that you have a direct competitor comparison and it is discouraging to see us fall behind without an explanation after what seemed like a significant head start.
@Golgo17 - 1 month ago:MESO was lucky and was able to capitalize on a few things:Athersys had some pretty compelling Phase II data from MUST-ARDS for MAPC cells using the same MOA as MSC cells.Mesoblast had already been using the NIH's NHBLI network of 30 hospitals for their CHF trial since 2014, so they already had their foot in the door there.Mesoblast already had plenty of safety data from the two-infusion dosing regimen used in their GVHD trials for Remestemcel-L, so they just used the same dosing regimen for COVID-19 ARDS. They had no idea if it would work, mind you.... they just took a stab at it because it was the quickest route.
@biosectinvestor - 1 month ago:I think the initial compassionate use study showed a willingness to pitch in on solving this problem beyond self-interest. While it has no obvious regulatory impact, I think that plus that they have a biologic application for approval already submitted for their cells, probably put them in a very good place with US regulators. I think being in Cleveland, while it no doubt has some advantages, leads to a bit of a sheltered perspective on things. Meso’s office in the US is right on 5th Avenue and 42nd St. They are very much in NYC, despite being an Australian company.
@snotts - replies:Wow! Amazing how quickly they have moved. Almost sounds to good to be true. Our first mover status has evaporated.
@0454gman 4 weeks ago:Been thinking about this since it was posted, and am really uncomfortable with this whole ATHX/MESO/CovidARDS episode. Unfortunately, I am not sure this can end well for ATHX unless they move get after this in a major hurry. If MESO's trial is successful, then they become the first to the post (if nothing else, they get worldwide publicity- can't be bad). If it is not a successful trial, the market may paint all the ARDS stem cell trials with the same brush, which doesn't bode well for ATHX. (And, before anyone uses the "MAPCs are superior argument, the market doesn't/won't understand MAPCs vs. anything else). Very discouraging.. Yes, before it is said- Stroke is the big play- but this seems like it is moving toward being an opportunity missed
@stoketards - 4 weeks ago:Boggles the mind how they find all these testing sites like in Los Angeles and New York.They are much further than ATHX: https://finance.yahoo.com/news/mesoblast-reports-strong-financial-position-215301509.htmlOperational and Corporate Highlights for the Nine Months of FY2020:The United States Food and Drug Administration (FDA) accepted for priority review the Company’s Biologics License Application (BLA) to seek approval of its lead allogeneic cell therapy remestemcel-L2 for steroid-refractory acute graft versus host disease (SR-aGVHD) in children under the brand name RYONCILTM.3The FDA set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.
@Golgo17 replies:These sites are part of the NHBLI network they have already been using for their CHF trial since 2014. Using them for COVID-19 ARDS was as simple as making a phone call to NIH.
@CavScout - 12 days ago:I increased my MESO position upon learning of the MIS-C trial. I will buy one more lot on Monday as well. By far, a much smaller position than my ATHX one. MESO has many inflection points of their own coming very soon.CHF phase 3Low back pain phase 3PDUFA GvHDCV-19 ARDS interim
They came to HC to see why we weren't threatened by ATHX@jacob4719 2 months ago:A Comparison between Athersys and MesoBlastThe post below is from a MESO forum. I believe that Athersys is a better valued company, but seeing other’s opinions is interesting.
Post:https://hotcopper.com.au/threads/athersys-vs-mesoblast.5327521/?post_id=43874221
My thoughts:While I think many of the points in this post are interesting, it fails to point out 3 of arguably the most important details:-Athersys already has a Phase 2 study for ARDS complete which shows efficacy. A key detail for Covid.-Athersys’s cell technology (MAPC) allows for about 60 cell doublings from donor cells, therefor significantly greater scalability compared to Meso’s (MPC) cell doublings of 10-38. Scalability in a worldwide pandemic cannot be understated.-Stroke trials and future prospects.
@strokeards replies:For the most part each company is pursuing different claims to fame: Stroke for ATHX, while Meso is after CHF. COVID-19 ARDS is not where ultimately the money is.There is theoretical reasoning for using both kinds of stems cells. Neither is clinically proven.In regards to the linked post, not sure why the author uses unproven efficacy for treatment of UC; thats not what ATHX is currently pursing.Having said the above, I think neither of the companies is head and shoulders above the other, which is why ATHX's stock should be much higher than it is.
@psychologicalbias replies:I think your wrong. I think ARDS is gonna be the way to go. I’m a physician. Just my opinion
@Trader12157 2 months ago:The post is more than slightly one-sided in the way it is written and while having some facts fails to take into account trials where efficacy have been shown.I joined hotcopper.com to take a look at another thread titled "Competition. What competition?". It was also initially posted by "The Yankee", who also posted the "Comparison between Athx and Meso". I'm guessing "The Yankee" is "Left-e", the Meso cheerleader who keeps posting over on the Athx yahoo board.What really stood out for me while reading both the threads mentioned here was that Athx hardly got a mention as being of any threat to Meso in the area of ARDS. Part of that could be that it is an Aussie trading platform and as such the people on the platform have chosen to invest in an Aussie company involved in the stem cell sector without looking at other options. Or it could be a total lack of DD.It certainly contrasted with the hand wringing going on here regarding Meso beating us to the punch and doing things faster than us. I must admit I enjoyed this forum more before the whole COVID-19 crisis and before we all suddenly saw Meso as a competitor, but maybe that is because I, like many others here, am forced to question my investment thesis more.
ATHX investors hedge by investing in MESO@Rxanuity - replies:That is almost in line with my estimates posted elsewhere. On 5/1 I posted concern about their trial design (very rigorous and also containing interim analysis) and the quality of sites. The first cohort lost us at least a month and then we have to potentially enroll more patients in a shortened period. Our only hope to beat them is if they show futility (ours would also fail in all likelihood then also)Recognize in all likelihood we will be second, if there is a second wave in the fall we should still be able to benefit but we will not pop on the approval as much as meso. If you feel inclined you could hedge as I did earlier this month when it became evident we were most likely beat
@KingMan9696 replies: same. i caved a month ago and just bought myself a decent stake in $MESO so i can stop being upset with them constantly beating ATHX at everything. still have a lot more invested in ATHX and rooting for their success, but now at the inevitable MESO news about them beating us every week, i don't feel angry every single time.
@cervid1 replies:If you believe ATHX is behind, and in trouble, the most prudent thing to do is sell now, and invest in MESO. Most people will be getting out with a profit, and that should be taxed as long term gains. Stop being frustrated by Gil! Now is the time to take care of yourself, and your portfolio. Godspeed!
@KingMan9696 replies:I mean, it's not like longterm ATHX investors have been rewarded for their patience or to this point have picked a good longterm investment... https://imgur.com/a/6SOiu8c No price movement in over 10 years, while the S&P and Dow have tripled in that time. Time to shake things up maybe, guy. A good product backed by an idling company, idling board of directors, and idling CEO. Take the product and put it in the hands of a successful go-getter biotech CEO and businessman. Watch what happens then, the last 6 months probably could have gone VERY differently. Hate on me all you want, I've stated facts. And I want our investment to do well.
MESO investors jump to CYTODYN @askdoctorji - 17 days ago:Anyone else in CYDY? I sold all me MESO at like 11/12 bucks and put it all into CYDY at 2ish. If this happens to ATHX which I feel very confident it will, I will be a very rich man! This CYDY is prob my best trade in my life for now! I have a good amount of it to make me very happy.
@kck6214 replies:I'm in CYDY. Entered after selling MESO during the spike to 18.00. I'm struggling to find objective analysis of the company. Any recommendations?
@joel383 replies:CYDY are a pump and dump. Stay away. Long history of this.
@mingtin:That took a dive, CYDY, wtf happened?!!
Speculation about MESO using 2 doses for ARDS and cost ramifications@Gibis 1 asks:
Why is MESO using multiple does for COVID?Last week, we had Meso supporters claiming superior cell potency because Meso uses much lower MSC cell counts per dose than MAPC based Athersys.
So, why is Meso now using two doses for Covid treatment?
I did a review of their heart studies and a few other treatments and found no Meso trials using multiple doses. I could be wrong and there are some that I missed but I find this curious.
Think about the ramifications. Let's say both treatments work equally well.
We really do not have enough information to layout treatment costs side by side. But, it is my guess that when making dose batches the cost per cell content per batch is not a linear. Most of the cost per batch is in the set up, monitoring and batch testing. Those costs go on regardless of how many cells are in each dose.
I believe that Athersys will have enough manufacturing cost advantages that they will be able to be the lowest cost per dose producer even with Athersys larger cell counts. That means that if Meso needs to use two doses per treatment, their treatment cost per patient will be at least double that of Athersys.
My thinking is that if both companies reach commercialization, Meso will likely be at significant treatment cost and manufacturing capacity disadvantages compared to Athersys for the same treatment.
@Tcb2b replies:I think it has to do with the size of the cells. Athersys cells are smaller that is why they can give larger doses. While mesoblast are larger and can get stuck in the capillaries and lungs therefore they can’t give as large of a dose so they have to give two spread apart. This is 100 percent conjecture on my part.
@Gibis1 replies:Thinking about MAPC vs BM-MSC published researched comparisons, I got to thinking that those are cell to cell comparisons or batch to batch comparisons. I have not seen any dose to dose comparisons which is what the health care system will most care about.
@rootingforathx replies:Good stuff, Gibis. Since the early times of my investment, I have followed the thesis that MAPC cells are superior to MSCs for the very reasons to which you refer. If you are right about the oossible issues related to MESO dosing, then the thesis is correct and, ultimately, Athersys will be the dominant player in the space even if MESO is effective in the short term. As this race is on, it is important to remember that we are long game players. We are only at the start of a marathon. The winner will get a really, really, really big gold medal. The silver and bronze medals probably won't be too shabby either. But gold is within our reach.
@Golgo17 replied at the end:They used high multiple doses of TEMCELL for aGVHD in Japan, too.
Source "The approved and reimbursed dosing regimen in Japan for TEMCELL is as follows:For all patients, eight doses of 2 million cells/kilogram, delivered as an intravenous infusion.For patients with persistent symptoms beyond four weeks, a further weekly dose of 2 million cells/kilogram may be given for four additional weeks.Reimbursement for TEMCELL has been authorized by NHI as $7,079 per bag of 72 million cells. In Japan, the average adult patient is expected to receive 16 or up to 24 bags of 72 million cells. On this basis, Mesoblast expects a treatment course of TEMCELL in an adult Japanese patient to be reimbursed at $113,000 - $170,000."
ATHX investors losing confidence because of MESO@rogro777 - 1 month ago:No investor confidence in this stock anymore. There is nobody to blame but management. I have not been a Gil basher but the juxtaposition apples to apples of ATHX Mgt vs Meso Mgt is beyond obvious. Unfortunately I don’t have much confidence in the BOD anymore to even recognize the problem. Many of the long term holders here have gone silent as any defense of Mgt in the last few months rings hollow.
@DocBMD replies:Call me crazy, but even if MESO ‘beats us’ with results, and garners significant media attention etc, shouldn’t that still buoy our SP? A rising tide lifts all boats sort of phenomenon for the stem cell sector? Thank you for all of your contributions to this Reddit forum. There are some incredibly gifted DD finders here.
It does appear, at least peripherally, that the ATHX boat is rising with the MESO boat (MESO +73%; ATHX +66% last three months). It’s obvious how frustrated people who have been here for a while are. I can’t imagine how long of a time this has seemed for many of you. It certainly doesn’t help that Gil isn’t the cheerleader we all want him to be.But, at a fundamental level, nothing has changed...the science appears to meaningfully check out, they are performing the gold standard in empirical medicine, and there is multi-organ system application for common and lethal conditions that should garner unprecedented global attention when the clock strikes zero.
@Rxannuity replies:I've had similar concerns with MESO lately but I do not think they can for a couple reasons. MSCs have a tendency to get stuck in the lungs, great when you are targeting a lung disease, less great systemically or other organ systems. So intuitively they would need higher doses (more cells) which leads to greater costs and more side effects (assuming MSc and mapc potency are equal). The fact mapc divide approximately 20 more times than MSCs is another reason our high doses won't be readily acheiveable for mscs
https://www.reddit.com/r/ATHX/comments/gf6g9t/speculation_why_is_meso_using_two_doses_for_covid/
https://www.reddit.com/r/ATHX/comments/gsso81/i_have_not_been_a_gil_basher/
https://hotcopper.com.au/threads/athersys-vs-mesoblast.5327521/
(20min delay)