Athersys - Continue the Discussion

Jan 13, 2015 15:07:33 GMT dayanand33 said:

Today ATHX presents at Biotech Showcase @ 11 am pst

It's a live webcast, so folks can listen in if they want. I'll post my notes after the webcast.

I'm looking for 2 things: 1) updated guidance on when stroke results will be announced (hoping they hold guidance to the end of 1st QTR timeframe) and 2) elaboration on how they plan to leverage the new clinical trial regulations in Japan. Would love to hear them state they plan to apply for conditional approval for stroke in Japan if they see any efficacy signal in the Phase 2 results.  IMO, that's the plan.

Would also be nice to hear some tangible updates on the other programs (UC, GVHD, AMI, obesity) but I'm not holding my breadth as this company holds their cards very close to the vest, and doesn't announce anything until after its done.  Even then, they often don't take the opportunity to PR significant milestones which is the only frustrating thing with owning ATHX.

Jan 13, 2015 20:26:56 GMT stemwinder said:

Jan 13, 2015 19:53:55 GMT jckrdu said:

My notes & thoughts...

The major (and only) piece of new news shared is that their extensive reimbursement analysis projects that they can charge between $25k to $30k for a one-time dose for stroke. He went on to say the market size is approximately 2 million patients per year making stroke an annual opportunity in the $10s of billions. (My comments: While this was the only piece of new news, its significant as it'll give the analysts something to plug into their financial models.)

He confirmed stroke data release at end of 1st QTR 2015 "give or take weeks". I was happy to hear that. In terms of impacts to the pps, traders that were expecting some type of major bombshell new news today may be disappointed and add to the short-term selling pressure. But, overall stroke timeline for data was confirmed, so stroke run-up is still very much on track and will continue, IMO.

Japan - I was very happy he spent a good chunk of time discussing Japan's new regulatory environment. He stated Japan is leading the way in terms of accelerated regulatory approval, and that based on Phase 2 data, they can apply for conditional approval. He added that if conditional approval is granted, the new legislation allows for reimbursement by insurance companies. Nothing new... but it was good to hear an Athersys executive finally state it. Stated they have expended significant manpower in Japan. Said it would be a game changer for the company if they are successful. (I won't go into all the reasons he stated why they believe they'll be successful... preclinical data, multiple methods of action, etc... listen to the call for that.)

As expected, not much else was stated on the other programs... at least nothing new from my perspective:

UC Program - He stated they may have more to release over the coming year.
GVHD - In process of completing Phase 2/3 registrational study design. Said we'll start program with partner "sometime in the future".
AMI - Initiating Phase 2 "right now". Will start trial this quarter.
Obesity - Nothing mentioned.
Solid Organ Transplant (Liver) - He did discuss this a bit, but nothing new. Said trial was ongoing and if successful it would provide a big opportunity for any type of solid organ transplantation. Per clinicaltrials.gov, data may be ready 2nd QTR 2015.

Based on this call, I'm sitting tight with all my shares, and will still look to accumulate under $2.

Nothing new. This has all been endlessly speculated over on the Yahoo message board. I personally would not put much credence in anything athx management says. Especially after Gill pumped the company shamelessly just before UC results and created many disgruntled baggies. As I understand it, it all comes down to what you think the mechanism of action is for multistem and the role of the spleen/multistem in stopping inflammation in the brain after a stroke. A lot of people are skeptical especially after they diddled with the endpoints towards the end of the trial which is frowned upon and a big red flag for the fda.

It all comes down to stroke results which are coming in late-March/April-ish:  Any efficacy reported and the pps will move much higher.  Expectations are very low based on the prior UC results and as reflected in the current $150 million market cap. 

Endpoints were changed after the reimbursement analysis was completed for the Japanese market.  Changing the endpoints was needed to align the therapy for insurance reimbursement in Japan.  That's the priority.

Jan 13, 2015 21:11:47 GMT dayanand33 said:

Jan 13, 2015 20:33:52 GMT jckrdu said:

It all comes down to stroke results which are coming in late-March/April-ish:  Any efficacy reported and the pps will move much higher.  Expectations are very low based on the prior UC results and as reflected in the current $150 million market cap. 

Endpoints were changed after the reimbursement analysis was completed for the Japanese market.  Changing the endpoints was needed to align the therapy for insurance reimbursement in Japan.  That's the priority.

Regardless of the outcome of the trials, the stock is very likely to rise as the trial announcement date approaches. As the end date approaches you can always make a call about how much profits you want to take before and after the results. I think we are in a sweet spot now with limited downside.

Agree.

Below is the link to an investor who blogs on ATHX. A little pumpy, but he provides many good links to research on ATHX done elsewhere.  The title of his blog post today that he made after the webcast is titled "Will Athersys MultiStem Prove To Be A Viable Treatment Option For Ischemic Stroke?".

biojaxusa.blogspot.in/

Jan 14, 2015 0:24:45 GMT JHam said:

Jan 13, 2015 19:53:55 GMT jckrdu said:

My notes & thoughts...

The major (and only) piece of new news shared is that their extensive reimbursement analysis projects that they can charge between $25k to $30k for a one-time dose for stroke. He went on to say the market size is approximately 2 million patients per year making stroke an annual opportunity in the $10s of billions. (My comments: While this was the only piece of new news, its significant as it'll give the analysts something to plug into their financial models.)

He confirmed stroke data release at end of 1st QTR 2015 "give or take weeks". I was happy to hear that. In terms of impacts to the pps, traders that were expecting some type of major bombshell new news today may be disappointed and add to the short-term selling pressure. But, overall stroke timeline for data was confirmed, so stroke run-up is still very much on track and will continue, IMO.

Japan - I was very happy he spent a good chunk of time discussing Japan's new regulatory environment. He stated Japan is leading the way in terms of accelerated regulatory approval, and that based on Phase 2 data, they can apply for conditional approval. He added that if conditional approval is granted, the new legislation allows for reimbursement by insurance companies. Nothing new... but it was good to hear an Athersys executive finally state it. Stated they have expended significant manpower in Japan. Said it would be a game changer for the company if they are successful. (I won't go into all the reasons he stated why they believe they'll be successful... preclinical data, multiple methods of action, etc... listen to the call for that.)

As expected, not much else was stated on the other programs... at least nothing new from my perspective:

UC Program - He stated they may have more to release over the coming year.
GVHD - In process of completing Phase 2/3 registrational study design. Said we'll start program with partner "sometime in the future".
AMI - Initiating Phase 2 "right now". Will start trial this quarter.
Obesity - Nothing mentioned.
Solid Organ Transplant (Liver) - He did discuss this a bit, but nothing new. Said trial was ongoing and if successful it would provide a big opportunity for any type of solid organ transplantation. Per clinicaltrials.gov, data may be ready 2nd QTR 2015.

Based on this call, I'm sitting tight with all my shares, and will still look to accumulate under $2.

Jckrdu,

Thanks for the update. I wasn't able to listen to the call so it was helpful (although I am going to try and listen later). A couple questions I have had on mind.

1) Why does Gil seem to feel that the new legislation in Japan is such a perfect match specifically for ATHX? Reading over the new legislation, I don't see what makes it any different for any other company in regenerative medicine, yet not every company is chomping at the bit like ATHX. Just wondering why Gil thinks this is so special for ATHX.

2) Before you mentioned that ATHX could use positive Phase 2 stroke results to obtain conditional approval in Japan. Does this snippet from the SA article/Gil interview suggest that they will first need to do a single trial in Japan before being able to obtain it?

"The idea behind the new framework is that they are making it possible for companies developing regenerative medicine products to run a single clinical trial and if safety and evidence of therapeutic benefit is obtained, the company could obtain conditional approval in Japan. This would dramatically shorten the time to market, and could accelerate the ability to create value. That could be very important for our shareholders if we are able to effectively utilize the new framework."

Plus this part from the Mesoblast PR about "bridging studies" in Japan.

"Conditional product approvals will be based on existing Phase 2 trial results demonstrating probable efficacy and safety with bridging studies"

Is there anything else you can point me to from Gil etc...where they make it clear about being able to obtain conditional approval in Japan solely from Phase 2 results? Did he go into detail about that on the call? Thanks!

A couple of quick responses...

You asked "Is there anything else you can point me to from Gil etc...where they make it clear about being able to obtain conditional approval in Japan solely from Phase 2 results? Did he go into detail about that on the call? Thanks!"

Yes, BJ (The President and COO) stated that on the call.  In my post from earlier today I mentioned that was one of the key things I was looking for from this call, as before the call all we had was the Mesoblast PR.  Today, BJ stated on the call that - assuming good Phase 2 data showing safety and some efficacy - they can apply for conditional approval based on those results. 

He then went on and made it clear that the new legislation also includes reimbursement from Japanese insurance companies.  (It's one thing to be able to treat patients early - i.e. compassionate use in the US - but its another thing to actually get reimbursed for it).  So BJ laid out the 3 key points of why ATHX is such a compelling/interesting speculative investment right now 1) they can get conditional approval to sell Multistem in Japan for stroke based on Phase 2 data generated in the US and coming at the end of March-ish, 2) they can get reimbursed from Japanese insurance companies for the treatments, and 3) the reimbursement will be $25k to $30k per treatment.

He then further added that they're working with potential partners on other indications besides stroke in Japan as well, because of the incredible new accelerated regulatory rules.

Jan 14, 2015 0:43:13 GMT JHam said:

Jan 13, 2015 21:37:46 GMT stemwinder said:

Yes Biojax is a known shameless pumper. Another one to be wary of is Wall_street_titan. 

These two cleared off after the UC debacle and deleted all their previous pump posts. They are back in town for the next pumporama.

stemwinder,

I don't disgree about pumping bloggers and CEOs. I have learned to try and do my best not to get caught up in hype from pumpy shareholders or over-promising CEOs (thanks Gary Rabin). Gil's "enthusiasm" of UC seems to have certainly left a bad taste in many people's mouths. I am just going by what the data has shown so far in stroke and based on how the science works the likelihood of it working better for stroke. As others have said, the big lure here for me though, is the run-up prior to results. If everything goes as planned, there should be a chance to get out with some profits even before results are announced, a la BCLI. 

Yes, a couple or three weeks prior to the UC results he appeared on this pumpomercial: 

www.thestreet.com/_yahoo/video/12523883/athersys-ceo-trial-results-will-prove-stock-surge-sustainable.html?cm_ven=YAHOOV&cm_cat=FREE&cm_ite=NA&s=1

I have to admit that the guy is good at what he does, which is get excited about Multistem. I almost get physically sick when I hear newbies talk about how excited Gil is about 'whatever'. He can turn it on a the drop of a tube of Brylcreem.

You mention that you are just going by "what the data has shown so far in stroke". What has the data shown in stroke? Has there been any stroke data published? I am not aware of any. I see a lot of speculation about some Doc saying something possibly went well somewhere, though its not clear if he is talking about Multistem, or some procedure they do at the hospital.

You also say "based on how the science works". How does the science work? I'm not sure that is even clear to Athersys. Some people talk about the action of Multistem on the spleen, and that it 'possibly' reduces the amount of inflammation in the brain post stroke. But I don't  know if this is proven science in humans by any means. Even if it does have an impact on the spleen, is that going to be beneficial to a stroke patient? I just don't know. It's all kind of a crap shoot.

You talk about the run-up prior to results. There may well be a continuation of the rise we have seen from the low $1.20's. And you may be able to time it so you get out prior to the beans being spilled. Two points to consider though:

1. There are a lot of baggies who got sucked in in the high 3/low 4's, who stick pins in voodoo dolls of Athersys management and want to get out when this gets a bit higher to a respectable level. Will it get to $4 with the overhead resistance? Who knows.

2. One thing that sucked with the UC data dump is people knew it was coming but not the exact date. Punters woke up one morning to the PR from hell. There was no for-warning. They just put it out there. Hopefully they do a better job with the stroke data and give people time to position themselves appropriately.     

I see Gil as a more educated, polished version of Rabin. These skanky little biotechs have a lot in common IMO.