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Friday, 01/21/2022 12:38:13 PM

Friday, January 21, 2022 12:38:13 PM

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BCLI, PSTI Athersys: Near-Term Progress In Stem Cell Phase 3 Trials Could Multiply Shares In 2022 by Arthur Frentzel

Athersys: Near-Term Progress In Stem Cell Phase 3 Trials Could Multiply Shares In 2022
Jan. 20, 2022 2:34 PM ETAthersys, Inc. (ATHX)BCLI, MESO, PSTI32 Comments13 Likes
Summary
Company has a robust pipeline in late-stage clinical development largely unknown to investors.
Enrollment for stroke phase 3 and ARDS trials is now complete in Japan and well underway in the U.S.
A leader in stem cell technology, company has a market cap near $182 million, a fraction of many clinical, late-stage biotechs with lessor prospects.
Multiple catalysts could multiply the share price in 2022.
Female Scientist in Lab
gevende/E+ via Getty Images

Many healthcare professionals and laymen alike believe stem cells are the future of medicine. Stem cells are derived from living cells that not only treat injuries and diseases, but also repair damaged tissue and organs. Yet, stem cells have been studied well over 50 years with only a short list of FDA approved therapies. In addition, stem cell development has been limited by widespread ethical concerns in the use of embryonic stem cells, which has been prohibited. Several recent stem cell trials have failed to meet endpoints, dampening investor enthusiasm. Due to a high level of risk in stem cell programs, big pharma and biotech have barely participated in their development. As a result, stem cells have been left to tiny biotech companies that are mostly unknown including Athersys (ATHX), Brainstorm Cell Therapeutics (BCLI), Mesoblast (MESO), and Pluristem (NASDAQ:PSTI). Athersys Inc., founded in 1995 with an IPO in 2006, has focused on developing its proprietary version of stem cells to address some of the most devastating unmet medical needs. Currently four phase 3 trials are well underway in studying its proprietary Multistem as a therapy for ischemic stroke and ARDS (acute respiratory distress syndrome).

Multistem is described as (quoted below)

Multipotent Adult Progenitor cells (MAPC) are nonhematopoietic stem cells, present within the bone marrow that can be grown extensively and can be induced to generate cells with phenotypic characteristics and gene profile of cells derived from endoderm, ectoderm and mesoderm. The capacity to differentiate into these diverse cell types distinguishes MAPC from Mesenchymal Stem Cells (MPC), and suggests that MAPCs may therefore be an ideal cell for in vivo therapies for tissue repair or regeneration in multiple organ systems (Jiang Y et al Nature, 2002; 418:41-49)."

Stem cells could be considered growing stems with potential to develop into many types of cells. Accordingly, they can modify cell structures and repair damaged tissue and organs. This can be illustrated with what happens in ischemic stroke, which occurs when an artery in the brain is blocked by a blood clot. The body reacts with inflammation at the point of injury, termed a cytokine storm. Excessive inflammation can then cause tissue loss and scarring of the brain. Once administered, Multistem migrates to the point of injury to interact with other cells (see below) to neutralize macrophages associated with inflammation. In addition to reducing inflammation, Multistem then works to modify cell structures, repairing damaged tissue. The science underlying the MAPC technology developed by Athersys is well-described in a video with Dr. Sarah Busch, Director of Regenerative Medicine at Athersys.

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