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Post by imz72 on Mar 19, 2021 0:07:13 GMT
I guess Hardy had discussions with the PMDA and they told him they want the enrollment to be completed as designed. Of course he can end the trial anytime but if he seeks approval he'd better do what satisfies them. Healios had the Q4 2020 CC in February. Next Friday they will hold their annual shareholders' meeting. As far as I recall they always hold it in the last week of March and it's focused on formalities, so there is no reason to expect news (unless "this time it's different"). How do you know he had discussions with the PMDA about this? Did I miss that revelation? Or just speculation? Ok, thanks for the correction on the annual meeting. Still, Hardy needs something to talk about so why not top line data for the Covid pts? He shouldn't need more than 6 weeks to analyze data for 5 patients in an open label study. Hoping we hear something out of Japan next week. Well I don't know that and that's why I used the word "guess". Hardy said he had consultations with the regulatory authorities in Japan before adding the Covid-induced ARDS cohort to the One-Bridge trial and mentioned more than once that Healios will consult them after having the results, so it's reasonable to assume that he has some sort of ongoing contacts with them. There was also this article two months go that doesn't relate to Healios specifically but could indicate that the PMDA may show flexibility in order to deal with the problems caused by the pandemic. |
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Post by tmfbmf on Mar 20, 2021 13:16:43 GMT
How do you know he had discussions with the PMDA about this? Did I miss that revelation? Or just speculation? Ok, thanks for the correction on the annual meeting. Still, Hardy needs something to talk about so why not top line data for the Covid pts? He shouldn't need more than 6 weeks to analyze data for 5 patients in an open label study. Hoping we hear something out of Japan next week. Well I don't know that and that's why I used the word "guess". Hardy said he had consultations with the regulatory authorities in Japan before adding the Covid-induced ARDS cohort to the One-Bridge trial and mentioned more than once that Healios will consult them after having the results, so it's reasonable to assume that he has some sort of ongoing contacts with them. There was also this article two months go that doesn't relate to Healios specifically but could indicate that the PMDA may show flexibility in order to deal with the problems caused by the pandemic. Yeah, I'm sure they are in contact but not about whether or not to end the trial with 29 or 30 patients. I don't know what the PMDA could advise without seeing the data. Then again, Japan regulatory authorities may act differently than in the US and I have no experience dealing with them. |
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Post by CM kipper007 on Mar 21, 2021 15:40:26 GMT
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Post by jckrdu on Mar 25, 2021 14:35:02 GMT
Added a little more at $1.65.
Keeping some cash available in case they have to raise more capital before a partnership is secured.
Looking forward to hearing enrollment completion news for ARDS & stroke, so we can start putting some stakes in the ground.
GL all.
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Post by CM kipper007 on Mar 25, 2021 17:55:40 GMT
Added a little more at $1.65. Keeping some cash available in case they have to raise more capital before a partnership is secured. Looking forward to hearing enrollment completion news for ARDS & stroke, so we can start putting some stakes in the ground. GL all. Just to clarify, you are not expecting to hear completion for ARDS & stroke for the Healios trials today are you? I would have thought Healios would want to announce that. |
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Post by jckrdu on Mar 25, 2021 19:07:11 GMT
Added a little more at $1.65. Keeping some cash available in case they have to raise more capital before a partnership is secured. Looking forward to hearing enrollment completion news for ARDS & stroke, so we can start putting some stakes in the ground. GL all. Just to clarify, you are not expecting to hear completion for ARDS & stroke for the Healios trials today are you? I would have thought Healios would want to announce that. Kip - Correct... I'm not expecting to hear enrollment completion news today, but it wouldn't surprise me if Helios chooses today to announce it (ARDS enrollment completion) at their quarterly call. May take a bit longer to complete enrollment as Covid really slowed things down. |
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Post by CM kipper007 on Mar 25, 2021 20:49:05 GMT
Partnership - This was something I thought we would have heard about sooner than the call if it was happening.
So, BJ confirms ... at least as I heard, no partner until they see results from treasure? And I do get that puts them in a stronger position to get the best deal, but where will the cash to keep the lights on come from?
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Post by imz72 on Mar 25, 2021 21:27:17 GMT
but where will the cash to keep the lights on come from? Aspire, as usual. From the 10-K Form: _____________________________________________________________ 215,244,507 shares of common stock outstanding on March 19, 2021. During the years ended December 31, 2020, 2019 and 2018, we sold 11,425,000, 14,475,000 and 8,708,582 shares, respectively, to Aspire Capital at average prices of $1.67, $1.41 and $1.78 per share, respectively. During the quarter ended December 31, 2020, we sold an aggregate of 4,205,000 shares of common stock to Aspire Capital under our equity purchase agreement, generating aggregate proceeds of $7.7 million. In the first quarter of 2021 through March 19, 2021, we generated an additional $26.6 million in proceeds from the use of our equity purchase arrangement, and we have 12,205,000 shares remaining for future issuance under the current registration statement. over $62.4 million available under the arrangement as of March 19, 2021 at March 19, 2021, we had $61.5 million in cash and cash equivalents During 2020, we increased our head count by adding 18 new employees in the areas of clinical and process development, research, operations and supply chain, regulatory affairs and across our general and administrative functions. As of December 31, 2020, we employed 97 full-time employees, including 17 with Ph.D. degrees. www.sec.gov/Archives/edgar/data/1368148/000136814821000037/athx-20201231.htm |
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Post by imz72 on Mar 26, 2021 1:39:23 GMT
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Post by klrjaa on Mar 26, 2021 12:00:12 GMT
Partnership - This was something I thought we would have heard about sooner than the call if it was happening. So, BJ confirms ... at least as I heard, no partner until they see results from treasure? And I do get that puts them in a stronger position to get the best deal, but where will the cash to keep the lights on come from? Hi CM I think pretty much assured that will be the case. BJ left the door open a bit though. Quote below. Says to me they are not totally closing the door, but the opening gets narrower as they get closer to Treasure readout which makes obvious sense. So highly likely outcome is as you state, as I doubt BJ was using the call as a means to continue negotiations. ATHX/any partner would have come to agreement by now if there was this was seen as a "must do" by both, IMO Also sounded like still work to do in terms of proving commercial scalability so potential partners way want to see that solved. BJ "As a result, the closer we get to important data readouts, such as the TREASURE study data, the more consideration we will give to the impact of the readout on our partnership strategy. Put another way, we do not feel compelled to complete a deal before we have clinical data. It is more important for us to do the right deal with the right partner." and "We feel very confident at this point that we have a platform that would enable us to serve large markets. As I noted in our prepared remarks, one of our key priorities is essentially achieving proof of principle around this." |
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Post by jckrdu on Mar 26, 2021 13:05:30 GMT
Partnership - This was something I thought we would have heard about sooner than the call if it was happening. So, BJ confirms ... at least as I heard, no partner until they see results from treasure? And I do get that puts them in a stronger position to get the best deal, but where will the cash to keep the lights on come from? Hi CM I think pretty much assured that will be the case. BJ left the door open a bit though. Quote below. Says to me they are not totally closing the door, but the opening gets narrower as they get closer to Treasure readout which makes obvious sense. So highly likely outcome is as you state, as I doubt BJ was using the call as a means to continue negotiations. ATHX/any partner would have come to agreement by now if there was this was seen as a "must do" by both, IMO Also sounded like still work to do in terms of proving commercial scalability so potential partners way want to see that solved. BJ "As a result, the closer we get to important data readouts, such as the TREASURE study data, the more consideration we will give to the impact of the readout on our partnership strategy. Put another way, we do not feel compelled to complete a deal before we have clinical data. It is more important for us to do the right deal with the right partner." and "We feel very confident at this point that we have a platform that would enable us to serve large markets. As I noted in our prepared remarks, one of our key priorities is essentially achieving proof of principle around this." Yep. Any deal (if one was put on the table) isn't good enough for ATHX to accept. I like that they lengthened their runway using Aspire, so they can continue partnership "discussions/negotiations" from a position of strength. IMO, they'll accept a deal pre-data only if its in the ballpark of what they're looking for. IMO, ATHX/Helios are confident that at least conditional approval for ARDS & stroke in Japan will be forthcoming after data readouts, so with the near/mid-term cash issue now resolved... they don't feel compelled to jump at any offer. Makes sense, IMO. On ARDS - Good that they'll be slow-walking the ARDS trial now that BARDA dis-engaged. The 10K contains a few statements about "slowing down" other programs to conserve cash... which IMO refers to ARDS and is the right move as they deploy their cash on Stroke/ARDS support in Japan and manufacturing scale-up. On manufacturing scale-up to 3D bio-reactors - IMO they're on a defined path to establishing "proof of principle" where the majority of the unknowns are now knowns. IMO, the 1 big unknown will be what the FDA requires as part of the "demonstration of comparability" that they've now started talking about in the 10K. That was always the mystery... how do they logistically make the switch from 2D to 3D? As noted in the 10K, the FDA may require additional clinical studies to make the switch to 3D bioreactors... so IMO, that's probably the biggest remaining risk, and IMO is the "risk" BJ mentioned in the company PR. Not much clarity on how Nikon is mitigating this risk for Japan commercialization. ________________________________ From Page 9 of the 10K"While the MultiStem product platform continues to advance, we are engaged in process development initiatives intended to increase manufacturing scale, reduce production costs, and enhance process controls and product quality, among other things. These initiatives are being conducted both internally and outsourced to select contractors, and the related investments are meant to enable us to meet potential commercial demand in the event of eventual regulatory approval. We are developing a bioreactor-based manufacturing platform for such commercialization. In our clinical studies, we are continuing to use cell factory-based material and plan to use bioreactor manufactured product. As we prepare for potential commercialization, we believe that the cell factory-based approach for production is not well suited for serving, on more than a limited basis, large markets or conditions requiring higher dose treatments due to the limited potential for scale-up, relatively high costs and the possibility of reliability issues due to the complexity of the cell factory-based manufacturing process. A full transition to bioreactor based material for the commercial setting will require a demonstration of comparability, which could include the requirement for analytical and in vitro data, some non-clinical studies and possibly data from additional clinical studies. Until such time as we can manufacture products ourselves in accordance with good manufacturing practices, or GMP, we will continue to rely on third-party manufacturers to make our MultiStem product for clinical trials and eventual commercial sales." d18rn0p25nwr6d.cloudfront.net/CIK-0001368148/164c3ebe-220f-4cc9-b2e9-260a7ce0168d.pdf |
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Post by selluwud on Mar 30, 2021 12:36:20 GMT
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Post by selluwud on Mar 31, 2021 11:06:00 GMT
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Post by imz72 on Mar 31, 2021 13:21:42 GMT
Reminder Hardy at Goldman Sachs Healthcare Conference (6.11.20): "We believe there are reasonable odds that we might receive full approval based on this one small trial. If not, we expect the conditional approval path to be available."
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Post by CM kipper007 on Mar 31, 2021 18:01:37 GMT
Reminder Hardy at Goldman Sachs Healthcare Conference (6.11.20): "We believe there are reasonable odds that we might receive full approval based on this one small trial. If not, we expect the conditional approval path to be available." You have a database for a brain IMZ. Love how you always remember the details. |
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Post by CM kipper007 on Apr 1, 2021 8:46:23 GMT
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Post by avtech on Apr 1, 2021 10:57:25 GMT
Thanks for this CM kipper007. Sounds like Athersys will begin receiving a steady revenue stream mid-2022 from Helios. |
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Post by CM kipper007 on Apr 1, 2021 22:48:30 GMT
Thanks for this CM kipper007. Sounds like Athersys will begin receiving a steady revenue stream mid-2022 from Helios. We still need those trial results first and they need to be favorable!! |
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Post by tmfbmf on Apr 20, 2021 13:05:03 GMT
I asked Hardy about his opinions on the Athersys proxy. Here is his response:
Thank you for your message. You are correct that good corporate governance and protecting shareholder interests are important to me. I am supportive of Athersys's proposal to increase the authorized share count from 300 million shares to 600 million shares and Healios will be voting its shares in favor of this proposal. It is important to recognize that this is simply an increase in the shares authorized for issuance if needed by the Company for any purpose in the future - this provides flexibility, it is not immediate shareholder dilution. Regarding your other question, I do not currently believe any directors should be replaced and Healios will be voting its shares in favor of each of the directors at the Annual Meeting.
Sincerely,
Hardy TS Kagimoto,MD
Chairman&CEO
Healios=Life Explosion
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Post by kamikaze on Apr 20, 2021 16:44:50 GMT
TMFBMF:
Respectfully, I am interested in why you would seek Healios take on the proxy, and wondering if you also reached out to another board members as well?
Kamikaze
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