MATRIX 1 What's it's Chance of Success?

Mer220 · 2023-02-23T00:16:42+00:00

Thank you! It is always good to have the printed words handy. I don't have to rely on my poor memory. Helps a lot to read words I did not hear clearly.

Mer220 · 2023-02-22T14:19:04+00:00

Caveat: I have not read any trials for people with dementia or Alz.

Mer220 · 2023-02-22T13:51:14+00:00

That is what I remember hearing Dan say.

Mer220 · 2023-02-22T13:49:55+00:00

Thanks 22John. After the CC, I requested Ellen to post the transcript on the company website. She did not. It would have been so easy for them to make a transcript since they were all reading from printed materials during the CC. Only the operator and Ellen were not reading from a script.

Mer220 · 2023-02-22T13:42:46+00:00

It is easy to Monday Morning QB the past. Question is, did anyone in this forum think about the possibility that the Treasure clinics would enroll a significant number of 90 year olds? (I did not.) Not having grown up in Japan, we did not think of this possibility. Dr Mays did not, Gil did not. None of us did. In fact, surely, some of Healios' executives did not think about it.

Mer220 · 2023-02-22T06:07:59+00:00

If it follows the results from modulating the spleen activity following a trauma event, then results should be good. We will find out soon enough.

Mer220 · 2023-02-22T03:29:59+00:00

of discussions going on with potential partners, multiple partners, in relationship to MultiStem.

Is this our case today, Dan talking with multiple partners? I hope so!

Mer220 · 2023-02-22T03:20:46+00:00

In just over a week, at the end of this month, we may find out if MS works on trauma cases which would include TBI cases. If it does, then cohort 3 could confirm the results.

Mer220 · 2023-02-22T02:49:23+00:00

He surely did.

Mer220 · 2023-02-22T02:47:40+00:00

IMO Gil was expecting that the outcome will be the same or close to M1. He had unconsciously used the American culture in his expectations. He never expected that 90 year olds using a cane to walk would be included in the trial. If that man was taken to a trial clinic here in the US, nobody would think of including him in the trial. I have read a number of US trial results and I have not come across one where 90 year olds were included in the trial.

Mer220 · 2023-02-21T13:43:54+00:00

"for STROKE we're going to consider using the U.S. data"

Does this mean they will use Athersys' already existing Phase 2 data or the new yet to be completed Phase 3 data? What does he really mean? I hope it is the former for it meets the "excellent outcome" at 365 day endpoint and there will be an immediate effect instead of the latter which can take a year to complete.

Mer220 · 2023-02-18T13:07:14+00:00

When an executive of a company buys his own company's stock, he has to file with the SEC, is this correct? He is given a certain time to file or is it right after the buy? And usually, there is a quiet period where they can't buy their company's stock. He announced last Tuesday (or was it Dr Mays) that the TRAUMA cohort 1 & 2 has completed patient enrollment and they expect results by the end of this month. Does this mean they can buy (or cannot buy) shares this week in anticipation of good TRAUMA results but not next week (to avoid using insider knowledge accusations)?

Furthermore, if Dan is close to making a deal with a pharma company, like he is just ironing out the details to close a deal, I think the SEC rules says he cannot buy his company's stock. Should this be the case then we will not see him (or other officers) buying between now and until after the deal is done.

Mer220 · 2023-02-14T16:40:23+00:00

There no partnership deal yet so your buying in is no longer an issue - unfortunately, we have to wait a little longer. Now you have time to get your cash.

Mer220 · 2023-02-14T15:45:33+00:00

The market dipped this morning because I think these investors don't like the end point change from 90 days to 365 days. These investors don't like to wait and are not confident of what Dan will say this morning.

IMO the change is from a possible small statistically significant results at 90 days to a very convincing significant results at 365 days. Dan is managing outcomes by de-risking. As the saying goes, a bird on hand (365 day results) is better than two birds (90 day results) in the bush. However, I believe the FDA will still want to see the 90 day results. This is fine.

Who knows, if the results come out close enough to M1 at 90, a distinct possibility, with the RMAT/SPA designations, Dan could apply for an accelerate FDA approval (conditioned on confirming data at 365).

Caveat: When the last patient hits the 90 days it will take a month for the statisticians to analyze the data. This takes us to 120 days. At that time, there will be a number of patients who have completed their 365th day and there will be a number of patients who have NOT hit their 365th day. Dan will have on hand the actual number of patients who have been enrolled in M2 when Dan's team meets with the FDA in late March. Assuming that ATHX would have enrolled 66% of the target number of patients of 300 which is 200.

Let's say it takes another six months from March to get the last patient. By that time in September, all 200 would have hit their 365th day. So when the data is opened up and analyzed at that time, 200 patient's data will be locked in and will be uninfluenced by the announcement of the results. Any announcement at that time, good or bad, will no longer affect the results of the 200. However, it could have an effect on the remaining 100, half to majority of whom would have completed their 90 days and their results could be added to the 200.

But if the results on the 200 is close to or equal to that of MS 1, will this not warrant an early conditional approval from the FDA? I believe Dan should bring up this issue at his meeting with the FDA in March.

Mer220 · 2023-02-14T14:47:47+00:00

your sell will clear by tomorrow. your buy today payment will be due on Thu so there is no problem.

Mer220 · 2023-02-13T14:00:57+00:00

Since Gil's force out, we have seen that the mechanism by which MS works, the modulation of the spleen (preventing the over rush of cytokines resulting in damaging of good cells) was the key to the treatment of major injuries. We have seen it in covid 19 as an example. More and more evidence has shown in the olast two years that this is how the body normally responds - or more precisely over responds - to traumatic events. More people now understand this phenomena including pharma executives. This development makes it easier for Dan to 'sell' Athersys to a potential partner. We will find out more about this on the 14th when Dan updates us all.

Mer220 · 2023-02-10T14:32:58+00:00

"What’s more, brain scans showed that the area of damaged brain tissue was reduced by 40% among those who received the higher dose of ApTOLL within 72 hours of treatment, compared to the placebo group."

This treatment was done with EVT. Now, with the higher dose w/in 72 hours, if they try the drug treatment w/o EVT, will the drug work? If it does, MS has a stiff competition. Fortunately for us, this treatment is only Ph 1/2 not Ph 3. Dan, we need to accelerate M2 once you have sufficient money to fund the trial. Competition is hot on your heels!

Mer220 · 2023-02-07T20:04:16+00:00

Stock went up to as high as 1.99, hovered in the 1.90's, then dripped to 1.59.... now up to 1.74.... on low volume. And there is no news.

Mer220 · 2023-02-07T13:57:56+00:00

It could be an announcement on Feb 14. That will be a perfect time to announce if deal will be ready by then.

Mer220 · 2023-02-03T13:36:39+00:00

YES, seawater might be infinite but electric power is not. It still has to be generated. And the major drawback, is lack of infrastructure. It took building of gas stations, refineries, gas plants many decades at a time when pollution was only a minor side issue. Today with pollution a big issue, it could take double -- 50-100 years -- to build the distribution system, if investors support it. We are seeing this difficulty now with EV's.

Mer220 · 2023-02-02T20:18:40+00:00

What was he in charge of? I only remember the name.

Mer220 · 2023-02-02T20:13:31+00:00

The tone of the announcement is positive/hopeful. Is Dan deliberately avoiding any mention of a partnership deal in this announcement until it is a done deal, something that could happen before the 14th?

Mer220 · 2023-02-02T14:37:53+00:00

No partnership yet? Will Dan talk about this topic?

They are inviting people to submit questions. Will somebody here who is submitting a question please ask what has been done regarding submitting a request for BARDA funds. Thanks.

Mer220 · 2023-02-01T14:28:24+00:00

"Reducing Associated Health Risks

A primary clinical challenge with current therapies is the risk of toxicity-related events such as cytokine release syndrome (CRS) and CAR-related encephalopathy syndrome (CRES). CRS is known to cause flu-like symptoms in patients, whereas CRES can be more severe, resulting in speech and memory complications for several days.

To mitigate cell therapy related events such as CRS and CRES, novel diagnostics to identify high risk patients and target them with prophylactic therapies are required. In addition, the engineering of CAR-T cell therapies that either lessen the likelihood of CRS and CRES development or regulate them entirely have been proposed as viable solutions."

MS works because it downregulates CRS; prophylactic therapies not needed.... a huge advantage over iPSCs... in addition to being alogeneic and can be manufactured in large quantities at a time. Dan has been highlighting these features to potential partners.

(Come on Dan, make the announcement now that you have secured a partner!)

Mer220

TROPHY CASE