Athersys - Continue the Discussion

twenty2

Price levels are really low... I was expecting a slow climb.

Anyone else worried we might see a company come in and buy us?

Slide 7 on Helios 8/10 Q2 Financial Results - Explanation of a Key Footnote Regarding When Enrollment was Completed (Link to Slide #7 is below):

There has been some discussion and disagreement (mostly elsewhere) on what the below footnote means on Slide #7 regarding when Treasure enrollment was completed:

"Completed after a period of time post administration to all patients to confirm that any drop-outs would not affect the analysis for efficacy."

I will provide my analysis below of what I believe the above means using an example where I parse the language in the above footnote with some numbers that may not reflect reality, but will be useful for illustrative purposes to explain the meaning of this footnote. So, let's assume the following in this example:

• "After a period of time" - Let's assume this "period of time" is 65 days. (Note that Helios has never stated what this "period of time" is, but many people are incorrectly assuming or speculating that its 90 days. Helios never said that the "period of time" was 90 days, and neither did Helios IR in their subsequent email response. .  In fact, the need for somewhat convoluted language in the footnote is because the "period of time" was not 90 days. The "period of time" was not determined in advance. More on this below.)

• "Post Administration to All Patients" - Let's assume All patients total 220. Let's assume all 220 patients were "Administered" the treatment by June 1st, with 218 patients treated well before June 1st, and the final 2 patients treated on June 1st.

• "Dropouts" - Let's assume 213 patients were treated and passed the 90 day threshold. Let's assume we have 5 actual dropouts that never made it to the 90 day threshold, and 2 more potential dropouts for the 2 patients treated on June 1st that haven't yet crossed the 90 day threshold.

• Maximum number of drop-outs to not "affect the analysis for efficacy" - Let's assume the maximum number of dropouts from the 220 patient trial is 7,and that any more dropouts would "affect the analysis for efficacy".

So, with all of that, what does the footnote mean?
It means that Hardy waited for as long as he had to (it turned out to be 65 days in this example from June 1st to August 6th), to ensure that enough patients crossed the 90 day primary endpoint threshold without dropping out.

It means that as of August 6th, even if all the remaining patients that had NOT yet crossed the 90 day threshold had all dropped out (2 patients in this example) Hardy knew if that worst case scenario played out and the total dropouts increased to 7 (5 actual + 2 potential) in Hardy's words per the footnote above - "would not affect the analysis for efficacy", as Hardy knew worst case he had 213 patients that crossed the 90-day threshold.

Hardy knew only at that point could he safely announce the completion of enrollment.

If that helps clear things up for 1 person, this post will have been worth the time.

GL All.
Go ATHX.

Link to Slide #7
ssl4.eir-parts.net/doc/4593/tdnet/2013100/00.pdf

PS: The June 1st final administration date I used in the example above lines up with Hardy's comment at the Advanced Therapies conference on 5/20/2021, that enrollment had not yet completed as of 5/20. You can hear Hardy himself make that statement on Page 182 of this thread.

Link to Hardy Stating Enrollment was Not Complete as of 5/20/2021 (Page 182 of this Thread)
thebiotechinvestor.freeforums.net/thread/82/athersys-continue-discussion?page=182

I would be that one person who has a little more clarity after your post Thanks Jkrdu

I am very excited for the near term! (and the far term for that matter)

Nice analysis of the foot note

fussin and cussin....but still holding damn it!!

Email from Hardy

I emailed Hardy the following:
Hello Dr. Kagimoto. I hope you are doing well. I was wondering if you have time to provide more insight into your decision to raise money before the data for the stroke and ARDS studies are public. There is a lot of speculation among investors that, having seen the data, you feel the need to raise money now because it will become more difficult when the data are public. Is there any truth to this?

Or, is it the case that commercial readiness must be demonstrated as part of the PMDA application and doing an offering at a later date is not feasible?

I know you can't say much to any individual investor, but I want to thank you in advance for any clarification you can provide.

Best regards,


His response:
After entering into the new collaboration agreement, Healios is in charge of preparation of manufacturing capabilities in Japan, we need to start investing now rather than later to build commercial supply.

Also we are acceralating the development of NK cells which has fantastic function as you can see with the video.
www.net-presentations.com/4593/20210810e/thdgbrngesrt/
Please see after 21:00
We believe we have the best in class iPS NK product in the world and we would like to beat our competitors including Fate. We would like to accelerate and start the clinical trials in the US which still takes years.

Finally, we have issues with the liquidity for big investors to come in.
It is mainly because i have too much shares still. We believe additional fund raise will enable to improve the liquidity of the shares in the market. As you saw, the share price is at the highest point historically but there is not enough shares coming into the market.
Although we have strong investors back up including Bailie Gifford, we should have better liquidity so that other sovereign funds can come in.

Sincerely,
Hardy

Not expecting anything new from Athersys. What I'm interested in is the timeline for Healios submitting ARDS approval application: Officialy it will be done in Q4 2021 or Q1 2022, but a recent news article indicated that Healios will apply by the end of this year.
Don't know though when the presentations will be made available.