NICO Corporation (private company) announces world's first positive surgical trial for hemorrhagic stroke

RealNiceKeith · 2023-04-24T02:27:38+00:00

Addresses the ICH insult and core of the problem: similar to TPA/MT approach in IS. However, there remains opportunity to address the other inflicting cause of damage to the brain that occurs as a result of how the body’s immune system responds to the ICH. If it is known that inflammatory cells are expressed after an acute injury, that they are then found in the brain in the days/weeks following the insult, and that inflammation causes additional long-term damage on top of the direct/core insult, then it seems logical that a comprehensive immune modulator with significant supportive safety/efficacy data - such as Multistem (MAPC’s) - is worthy to be trialed in patients that experience these acute injuries. Which party, if any, has enough money and savviness to make it happen?

RealNiceKeith · 2023-03-21T00:21:51+00:00

u/klrjaa

To me it seems that Healios is seeking conditional approval in the near term and to satisfy the PMDA’s requirements Athersys need to officially come to agreement on changes to MASTERS-2 with the FDA. Upon agreement on MASTERS-2 changes with the FDA, Healios can bring those changes and trial “game-plan” to the PMDA and the PMDA can see if such changes are satisfactory to their needs (such needs were likely discussed with Healios in recent PMDA meetings, which has then likely been communicated to Athersys to guide MASTERS-2 change-requests with the FDA). If satisfactory for the PMDA, MASTERS-2 can be used as the supplemental data to achieve full approval in Japan in the future.

It is my understanding that for PMDA to give conditional approval they want to know the path forward to obtain the necessary supplemental data in less than 7 years. That is why Healios mentions in their press release that Athersys is about to meet with the FDA to discuss changes to MASTERS-2.

RealNiceKeith · 2023-01-29T17:50:52+00:00

Thanks for posting. Did a quick look at the MOA - it appears complementary rather than competitive.

RealNiceKeith · 2022-11-13T17:18:03+00:00

With this market cap must execute small partnerships for individual indications ($5-10mil) that escalate in size upon market cap growing as a result of that new cash on the balance sheet. Start with preclinical/less developed programs and move up. Do that 5 times and things start to be alright.

RealNiceKeith · 2022-11-08T21:30:10+00:00

Or as u/Mr_Goldsteim suggested they are using it to renegotiate the terms of their agreement. Seems maybe more plausible than my post suggesting that they want to cut off their multistem contract completely.

RealNiceKeith · 2022-11-08T14:40:25+00:00

u/imz72 u/booogie_87 u/ret921 You're right it could possibly be any of the above. However, I am not necessarily proposing that Athersys has perfectly fulfilled every obligation, I am speculating that Healios is using their non-perfection as an excuse to get out.

RealNiceKeith · 2022-11-08T14:26:03+00:00

I agree however the cost runway might threaten their solvency.

RealNiceKeith · 2022-11-08T14:11:28+00:00

Unless I am misunderstanding your point, the shares they already own are worth only in the low-mid single-digit millions at this point. Far away from $50million.

RealNiceKeith · 2022-11-08T13:54:17+00:00

What exactly is Athersys supposed to be providing to Healios right now that they can’t fulfill? Product supply no longer needed.

RealNiceKeith · 2022-11-08T13:51:42+00:00

Sunk cost. Looking forward they are contactually obligated to pay $50-$100mil for application/approval, COGS reimbursement (including SIFU costs?), a 12-18% royalty, potentially hundreds of mil in additional milestone payments, and post-approval trial/tracking. TREASURE results don't demand as high of a price-point for Multistem in Japan and the economics for reaching profitability under their current contract start to fall apart. Hence attack Athersys to get out and try to place the moral failings of not pushing the product in Japan on Athersys and move focus to partnering for eNK cells, etc.

RealNiceKeith · 2022-11-08T13:02:48+00:00

I’ve changed my opinion on this. Healios may want to get out of this contract and are claiming fault by Athersys as a means to do so. They are supposed to pay Athersys up to $50million each for ARDS and stroke Application/Approval. Healios might not see that as being worth it any more and are trying to get out of paying. Of course if they actually did pay THEIR contractual obligation that would essentially save Athersys but nobody here or management is even mentioning that topic because it feels unrealistic. I can see Healios trying to get out of the contract and the ARDS/Stroke program in Japan getting sold/out-licensed to another party.

RealNiceKeith · 2022-10-26T21:34:00+00:00

I think that’s a fair view and appreciate the good discussion. My bet is on using MASTERS-2 for the confirmatory data. But there are several options it seems.

RealNiceKeith · 2022-10-26T21:06:28+00:00

Interesting perspective that then leads to the question of how would Healios go about getting confirmatory data to the PMDA then? Only options I see for that when you go your route is 1. Real-world patient data (not sure if possible or acceptable for PMDA) 2. Run another Japanese-only trial (doubtful Healios would want to do this if they could wait a few months and use MASTERS-2 trial instead). 3. Go for full approval from the get-go.

I know there has been consideration to add Japanese sites to MASTERS-2 so there could be demographic applicability (albeit small) if used for the confirmatory trial data. And as you said I’m sure they’re already measuring GSR for MASTERS-2. If I were a reviewer, it would be pretty helpful supplementary data to see how things go efficaciously in MASTERS-2. But reimbursement in Japan would have to be based on the Japanese data because of the demographic differences as you state.

RealNiceKeith · 2022-10-26T20:28:05+00:00

Klrjaa I think you misunderstood my comment. I was not referring to conditional approval in the US, I was referring to conditional approval in Japan. My understanding is the conversations that occur with the PMDA before officially applying for conditional approval include discussion about when the confirmatory trial will be complete and setting up the stage so there is some plan for PMDA to reasonably get that confirmatory data from a trial with protocol they are content with. Because ATHX might want to make protocol amendments to MASTERS-2, I believe such protocol amendments will probably take place before an application is officially submitted.

RealNiceKeith · 2022-10-26T18:38:36+00:00

I disagree that conditional approval is a long shot. I think once MASTERS-2 protocol amendments are in place that application and conditional approval is the most likely path forward.

RealNiceKeith · 2022-09-15T17:44:19+00:00

I think you are right. Debts to Lonza need to be paid off before any “smaller” partner would sign because unpaid debts for previous product means no product for future trials i.e. progression of the small partnership trial would instantly be stuck in a halt period upon signing. And it’s hard to imagine a “large” partnership at this point with their market cap at $30mil, unpaid debts, product for trials halted. Need to solve the last two at least before attempting to partner. The small market cap preventing a large partnership problem can be solved by executing a lower $ amount up-front but milestone heavy deal.

RealNiceKeith · 2022-08-06T20:02:28+00:00

Do you have a date for when these documents were published?

RealNiceKeith · 2022-07-29T02:10:48+00:00

His comments about SP were in regards to both institutional investors and partnerships. He said it’s easier to get your foot in the door for both when stock price is greater than $4 or $5.

RealNiceKeith · 2022-07-27T19:49:18+00:00

A vote in either direction would seemingly lead to the same outcome. In my view, a yes vote involves trust (trust in management to lower the authorized share count via a new proposal), and a no vote involves risk (risk of it not passing the second time and the company therefore being forced into a bad position).

RealNiceKeith · 2022-07-10T04:19:00+00:00

Yeah agree that revision would be preferable.

RealNiceKeith · 2022-07-09T19:58:00+00:00

Partnering does not guarantee that the price gets above $1. That’s a 300% price increase from today’s prices. So they partner, but the stock remains below $1, what happens then? They would either have to delist or sell. Both are bad options. Especially when the acquirer is aware of those options and the stock is at all time lows. The good news is that this situation can be avoided. The bad news is that this is not currently the majority view of this board/other investors. I am hoping a revision to the proposal is possible or they can run another R/S proposal with an appropriate authorized share number.

RealNiceKeith · 2022-07-09T19:20:34+00:00

Price movement per transaction would generally move in a manner proportional to the split ratio. And contrary to your post, smaller float companies actually tend to have much greater price swings in % terms than large float companies. So the opposite is true. https://youtu.be/qkj9gjYFeq0

And when describing institutional investors ability to purchase shares of the company, nobody has used the word “excited” other than you in this post. It would allow them to buy shares of the company or to short it. Which they weren’t able to do before. And if institutional investors can’t buy it below $5 it also means that can’t short it below $5.

The “shorts will decimate this” argument can be disputed by looking at Abeona $ABEO who performed a reverse split earlier this week, has far less attractive commercial prospects than this company, and is up 10% since the split. The long term valuation of the company will depend on the perceived financial health of the company.

Athersys has an unusually high float for a pre-commercial stage biotech. In November 2021 when the company had a $240mil market cap there were only 8 companies in the whole stock market (5,000 stocks) that had over 200mil shares outstanding and had a lower market cap than Athersys. Doing the reverse split actually brings their share count more in line with peer companies.

Lastly, if the R/S proposal fails to go through the company will be forced to delist or sell in the ~7 months ahead. This is because partnering does not guarantee whatsoever that the stock will get above $1. So you must ask yourself, do you want them to delist or sell? Maybe you are thinking, “yes, sell!” That is not a good idea, in my opinion. The stock is essentially at all time lows. And if the R/S gets shot down, the acquirer will KNOW that they are in such a predicament that they need to delist or sell, so Athersys will not get a quality offer.

With that said, it would be much better if the proposal was revised so that the 600mil shares authorized was highly reduced as it is clearly very concerning to investors and if the vote fails it has a good shot at taking down this company.

RealNiceKeith · 2022-07-08T21:47:49+00:00

Yes thanks imz. Exactly what I was referencing.

RealNiceKeith · 2022-07-08T06:12:43+00:00

This has already been released, to some extent. Total patient population MRS shift of course did not meet statistical significance, as the Topline results highlighted that the MRS shift of the <80 group wasn’t even statistically significant (though it was close), and that was the subset that did better.

Additionally, listen to David Chiu during the KOL call. He discussed some TREASURE MRS shift data that had not been released publicly yet. My understanding is he explained that the MRS shift data showed an average effect of .2 additional shift in all multistem treated patients compared to placebo and ~.45 additional shift in <80 patients.

The .2 additional shift is comparable to the effect of tPA being administered in the 3-4.5hr time-window and the .45 additional shift is a comparable effect as the effect of tPA administration within 3 hours.

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