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GOOD LUCK LONGS ... HEALIOS K.K.
Hardy TS Kagimoto, Chairman & CEO (TSE Mothers Code: 4593)
Richard Kincaid, Executive Officer CFO (TEL: 03-5962-9440)
Full Enrolment of ONE-BRIDGE Study for Patients with ARDS
HEALIOS K.K. (“Healios”) announces that it has fully enrolled the planned patients in its ONE- BRIDGE study for Acute Respiratory Distress Syndrome (ARDS) *1, the clinical trial to test the safety and efficacy of HLCM051*2 in ARDS in Japan.
ONE-BRIDGE is an open-label study, the main cohort of which treated pneumonia induced ARDS patients with either HLCM051 or standard therapy. Regarding the overview of the trial, please refer to our company’s press release on April 22, 2019.
In addition to the main cohort, a second cohort was established to test the safety of HLCM051 in COVID-19 induced ARDS patients. Its enrolment was completed in August, 2020. For more information regarding the second cohort, please refer to our company’s press release on April 13, 2020 and August 12, 2020.
Going forward, we plan to analyze and evaluate the data after a follow-up period of patient enrolment.
If matters to be disclosed arise in the future that would impact fiscal year 2021 financial performance, Healios will make an announcement without delay.
*1 ARDS is a general term for the symptoms of acute respiratory failure suddenly occurring in seriously ill patients. The major causes are severe pneumonia, septicemia, trauma etc. Inflammatory cells are activated in response to these diseases or injuries, causing damage to the tissue of the lungs. As a result, water accumulates in the lungs, leading to acute respiratory failure. According to the ARDS treatment guideline 2016, the mortality rate is approximately 30 to 58%. Artificial respiration using an endotracheal tube or mask is used to treat respiratory failure in an intensive care unit.
*2 HLCM051
HLCM051 is a somatic stem cell regenerative medicine product. Healios added it to its pipeline by signing an exclusive licensing agreement with the United States based Athersys, Inc. (“Athersys”) in January 2016, whereby Healios acquired rights to develop and distribute Athersys’ proprietary stem cell product MultiStem® to treat ischemic stroke in Japan. Further, in June 2018 Healios and Athersys expanded their collaboration broadly, and as part of this expansion Healios acquired the development and distribution licenses to use MultiStem to treat ARDS in Japan.
March 31, 2021
This is a GOOD read for ALLLLLL ... GOOD LUCK LONGS
https://www.reddit.com/r/ATHX/comments/meh4nd/cc_thoughts_one_shareholders_perspective/?utm_source=share&utm_medium=ios_app&utm_name=iossmf
Some good news from Brainstorm ... GOOD LUCK LONGS
https://www.reddit.com/r/ATHX/comments/mc5ebt/some_good_news_from_brainstorm/?%24deep_link=true&correlation_id=1296bcf7-2773-4572-bc34-d85bf1e33ba5&post_fullname=t3_mc5ebt&post_index=1&ref=email_digest&ref_campaign=email_digest&ref_source=email&utm_content=post_title&%243p=e_as&_branch_match_id=829669447967134701
ATHX .. Form 4 Awarded nonqualified stock option in recognition of recent extraordinary service ..
http://d18rn0p25nwr6d.cloudfront.net/CIK-0001368148/e14f1901-7f10-4975-8605-fd3417dc60d5.pdf
ATHX .. Will be presented at the stroke conference 3/17/21 at 8:00 a.m.
To 9 p.m. CTP10. Multi stem ... GOOD LUCK LONGS
Would someone translate the transcript of Dr. Kasimoto" s
comments and forward at your earliest or KEEP QUIET .. The next move up will be after the rescheduled Virtual Investors Presentation. Healios should make a announcement of completion of Trial enrollment on ARDS or a EU Partnership. Healios should be announcing this rather than just leaving it to some of our imaginations....GOOD LUCK LONGS
https://reed-speaker.jp/Seminar/2021/interphex_osaka/top/
This is a buying opportunity with Healios READY for commercializing. They have regulatory backing regarding / reviews in stroke and ARDS, manufacturing in place with Nikon and now an agreement with a major distribution partner in Japan .. THIS IS A SLAM DUNK .. GOOD LUCK LONGS
Regarding the presentation their sales force is up 400% along with regional managers. They are also laser focused on the Sepsis business which is their core + the development of new panels including the BARDA funded ones. One thing that was revealing, as CEO was asked about competition.
T2 said that the competition often shows when the hospital buys two or there different machines and at times T2 is the most used. Don't get me wrong there's other times the equipment is the least used. When asked who do they often run into as the most used machines, the answer was Roche and Hologic. Don't know the reason for buying one versus the other, as we are not lab technicians and do not go to seminars to see all the machines on display etc. Also there is currently 11 million deaths due to sepsis world wide. This number has been increasing. They have made huge progress which it will continue .. GOOD LUCK LONGS
This is a BUYING opportunity NOTHING has changed regarding the product at hand .. The future is BRIGHT ... GOOD LUCK LONGS
Nothing MORE than a SHAKE OUT ..WHAT HAS CHANGED ??? NOTHING !! .. Let's get rid of alllllllllll WEAK hands ... GOOD LUCK LONGS !!
Goldman Sacks steps up to add more .. GOOD LUCK LONGS
http://investors.t2biosystems.com/node/10711/html
CLEVELAND, Ohio--(BUSINESS WIRE)-- Athersys, Inc. (Nasdaq: ATHX), a regenerative medicine company developing MultiStem® cell therapy, today announced that Dr. Gil Van Bokkelen has stepped down as Chairman and Chief Executive Officer, effective immediately. The Athersys Board has appointed William (B.J.) Lehmann, the Company’s President and Chief Operating Officer, as Interim Chief Executive Officer. Dr. Ismail Kola, Lead Director of the Athersys Board, has been appointed Chairman of the Board.
The Company’s Board is commencing a comprehensive search process to identify a permanent CEO. The Board intends to identify and select a CEO who can guide Athersys in the commercial stage.
“On behalf of the Board and everyone at Athersys, I want to thank Gil for his valuable contributions and years of service since co-founding Athersys in 1995,” said Dr. Ismail Kola, Chairman of the Athersys Board. “During Gil’s tenure, Athersys successfully established a portfolio of therapeutic product development programs to address significant unmet medical needs across several disease areas that represent substantial commercial opportunities. His vision, energy, tenacity and leadership have been critical for building Athersys into the leader in regenerative medicine it is today, and we wish him all the best in his future endeavors.
Dr. Kola continued, “As we advance our late-stage pipeline and lay the groundwork for commercialization of our MultiStem product, Gil and the Board have mutually determined that now is the right time to transition to the next generation of leadership to help drive the Company forward and position Athersys for long-term growth and success. Over the last several years, Athersys has made significant progress across our clinical programs and commercial readiness activities, and we remain excited about the future of Athersys and the potential for MultiStem to improve the lives of millions of patients globally. With two important clinical trials nearing completion in Japan in partnership with Healios, for which results are expected in 2021, and several of our own clinical studies, including our lead ischemic stroke program, we remain focused on preparing for important top-line data readouts and on developing our go-to-market strategy for MultiStem.”
“It’s been a privilege to lead Athersys, and I am proud of all that we have accomplished together,” said Dr. Van Bokkelen. “Athersys has a wealth of talent and some of the best and most knowledgeable employees in the regenerative medicine space, and I am confident that the Company’s future is bright and remains in good hands under experienced leadership as the Board identifies the right person to guide the Company through commercial launch. I look forward to following the Company’s exciting progress.”
Dr. Kola concluded, “We have great confidence in the strong executive management team that will be continuing to lead the company, consisting of B.J.; John Harrington, Executive Vice President and Chief Scientific Officer; and, Ivor Macleod, Chief Financial Officer. All three are seasoned executives with decades of leadership and operational experience. We appreciate that BJ has agreed to step into the role of Interim CEO while we search for a permanent successor. B.J., John and Ivor have made significant contributions to Athersys, and we are confident that it will be a seamless transition as we continue our evolution into a commercial company.”
Mr. Lehmann said, “I am grateful for the opportunity to have worked with Gil over the years and eager as Interim CEO to carry forward with the Company’s mission to develop the leading cell therapy company while addressing substantial unmet needs in large markets. I, John and Ivor look forward to working alongside the Company’s outstanding Board and management team to advance Athersys on our road to commercialization. We have great confidence in the Company’s strategic plan and in the many opportunities we have ahead of us to deliver value for both patients and shareholders.”
In light of today’s news, the Company’s Virtual Investor Day, which was scheduled for today, has been postponed and will be rescheduled at a later date.
Wouldn't be surprised if this does not end the day much higher once people digest thus, and a sign that ATHX is moving ahead from a development company to commercializing their technology. Most CEO's with the skills to develop products do not have the skill set to put them into reality. Plus the Healios news. Maybe not a buyout, but that is always possible as this makes that path more likely. Would be surprised if this does not end up significantly higher once people digest ... GOOD LUCK LONGS
It's finally happening ... GOOD LUCK LONGS
https://finance.yahoo.com/news/athersys-announces-cooperation-agreement-healios-125000095.html