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Discovering and Developing Innovative New Medicines Designed to Extend and Enhance the Quality of Human Life

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Discovering and Developing Innovative New Medicines Designed to Extend and Enhance the Quality of Human Life ® Discovering and developing innovative new medicines designed to extend and enhance the quality of human life. 2011 Annual Report Company Profile Athersys is an international, clinical-stage biotechnology company that is focused on developing novel and proprietary best-in-class therapies designed to treat significant unmet medical needs that extend and enhance the quality of human life. The Company is developing MultiStem®, a patented, adult-derived “off-the- shelf” stem cell product platform for multiple disease indications in the inflammatory & immune, neurological and cardiovascular disease areas. Current clinical-stage programs include: an ongoing Phase II trial to treat inflammatory bowel disease (partnered with Pfizer); an ongoing Phase II trial to treat damage from ischemic stroke; a recently completed Phase I trial to treat damage from acute myocardial infarction (heart attack); and a recently completed Phase I trial to prevent or reduce GvHD. MultiStem® Production Process Athersys has forged a network of strategic Scalable & Consistent alliances and collaborations with leading pharmaceutical and biotechnology Isolate Material “Off-the-shelf” Product with from Qualified Commercial Scalability Thaw & Administer companies, as well as world- Adult Donor (No tissue matching– renowned research and clinical Lot Release & Product allogeneic product) Characterization Testing Hundreds of thousands institutions in the United to millions of doses States and Europe to PRODUCT STERILITY obtained per donor further develop its Cell Isolation POTENCY platform and & Processing PURITY AND VIABILITY products. STABLE CYTOGENETICS EXTENSIVE SAFETY TESTING Clinical Product Cell Expansion Bank Master Cell Bank Creation Cell Concentration Substantial production advantages over MSC’s & other platforms (e.g. scalability, product consistency) Development Status of Key Programs Preclinical IND/CTA Phase I Phase II Phase III NDA/BLA Inflammatory & Immune Inflammatory Bowel Disease* HSC Transplant/GVHD Orphan Designation Solid Organ Transplant Physician-sponsored trial approved Diabetes Neurological Ischemic Stroke Traumatic Brain Injury Multiple Sclerosis MultiStem Spinal Cord Injury Cardiovascular Acute Myocardial Infarction PVD/PAD/CLI Congestive Heart Failure Metabolic 5HT2c Agonist (obesity, other) Orthopedic Other Bone Allograft** Potential for initial product launch in 2012 * In Partnership with Pfizer Inc. ** In collaboration with RTI Biologics, Inc. ® 2011 ANNUAL Report To My Fellow Shareholders: Phase I clinical trials evaluating MultiStem for acute myocardial infarction and for hematopoietic stem cell transplant, or HSCT, support, and are preparing to advance these programs into later-stage clinical de- velopment. Working with a leading transplant center in Europe, we also received approval to initiate a physician-sponsored trial to evaluate the administration of MultiStem to liver transplant patients. These clinical indications fall into three key thera- Gil Van Bokkelen, Ph.D. peutic areas: inflammatory and immune disorders, Chairman and Chief Executive Officer neurological conditions and cardiovascular disease. Each represents an area of significant opportunity. Athersys is a company that is committed to Inflammatory and Immune Disorders developing therapies with the potential to improve people’s lives and change the practice of modern Graft vs. Host Disease medicine. We believe MultiStem®, our proprietary We believe the fastest path to market may be our off-the-shelf stem cell therapy, has this potential. By clinical program using MultiStem to reduce the risk continuing to develop our current portfolio of clinical of Graft vs. Host Disease, or GvHD, in transplant and preclinical programs, we believe we will create patients. GvHD is a devastating complication of substantial value for our shareholders. HSCTs and is triggered by the activation of donor- derived immune cells, which attack the transplant We made significant progress in 2011, and as a recipient’s host cells. A significant cause of morbidity result, we now have five clinical-stage programs to and death, GvHD significantly limits the use of these evaluate this promising therapeutic for the treatment otherwise beneficial procedures. of diseases and conditions where there is significant unmet medical need. These include two ongoing In 2011, we completed a Phase I clinical trial Phase II trials: one in collaboration with Pfizer, where evaluating the safety and maximum tolerated MultiStem is administered to treat ulcerative colitis, dose of single- or repeated-dose administration of and another in which MultiStem is used to treat pa- MultiStem following an allogeneic HSCT in patients tients who have suffered a stroke. We completed two being treated for leukemia or related conditions. In Inflammatory Bowel Disease Our most advanced clinical program involves administration of MultiStem for the treatment of inflammatory bowel disease, or IBD. This disease affects approximately 2.4 million individuals in the United States, Europe and Japan. Under our global collaboration for IBD, our partner, Pfizer, is conducting a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the safety and efficacy of MultiStem for the treatment of ulcerative colitis in 126 patients. Enrollment for this trial is ongoing and is expected to be completed near the end of 2012, and we anticipate initial results of this study will be reported in the first half 2013. 1 Hematopoietic Stem Cell Transplant Support/GVHD Despite the incidence of blood and immune cancers, just 25,000 patients annually undergo donor-derived hematopoietic transplant procedures. Risk of developing GvHD is a driving factor. Moderate to severe GvHD occurs in 30-50% of matched related and 50-70% of matched unre- lated donor recipients. Severe GvHD requires intense immunosuppression, with associated risk of serious infections. A therapy able to effectively address GvHD and other complications could help these patients, and also significantly expand the number of individuals that can receive treatment. this open label, multi-center study, MultiStem therapy MultiStem for GvHD prophylaxis and HSCT sup- was well tolerated in both the single infusion and port. This study would help lay the groundwork for repeat infusion arms. Study results suggest that regulatory approval in this indication, while continu- MultiStem may provide significant benefit to HSCT ing to establish the scientific foundation for Multi- recipients, such as by reducing the incidence and Stem in related areas, including GvHD treatment, severity of GvHD, as well as in other ways. We ulcerative colitis, solid organ transplant and other believe these clinical results could provide the foun- areas of immune system dysfunction. dation for accelerated development of MultiStem in this important indication. Inflammatory Bowel Disease Our most advanced clinical program is MultiStem We recently were granted a U.S. patent cover- for the treatment of inflammatory bowel disease, or ing the use of non-embryonic, multipotent stem IBD. This disease affects approximately 2.4 million cells for the reduction in severity or prevention of individuals in the United States, Europe and Japan. GvHD. This patent provides protection in the high Under our global collaboration, Pfizer is conducting value area of GvHD prophylaxis and transplant a 126-patient, randomized Phase II clinical study to support through 2028 and provides the basis for evaluate the safety and efficacy of MultiStem for the additional protection in related areas of treating treatment of patients with moderate to severe refrac- immune system dysfunction. tory ulcerative colitis. We expect patient enrollment We intend to move forward with development of will conclude near the end of 2012, enabling us to this program with input from the FDA. We plan to report data in the first half of 2013. conduct a blinded, controlled Phase II/III study of Neurological Conditions Ischemic Stroke Our lead neurologic program is MultiStem to treat ischemic stroke, a leading cause of death and dis- ability. Each year, approximately two million people suffer a stroke in the United States, Europe and Japan; worldwide incidence is estimated at 15 million people each year. Our goal is to develop a safe and effective therapy that could meaningfully improve the quality of life for patients that have suffered the debilitating effects of a stroke. 2 ® 2011 ANNUAL Report Traumatic Brain Injury In 2012, Athersys was awarded a grant of up to $1.9 million from the National Institute of Neuro- logical Disorders and Stroke, for the development of MultiStem to treat traumatic brain injury, or TBI. TBI is a serious clinical problem that affects predominantly young people and members of the armed services, as well as other adults. TBI results in nearly 1.4 million emergency room visits each year, leading to 275,000 hospitalizations and 52,000 deaths annually. In late 2011, we began a Phase II clinical trial designed to evaluate the safety and efficacy of We are collaborating with leading researchers on administering MultiStem to treat patients that have this program, which will include additional pre-clin- suffered an ischemic stroke. This double-blind, ical safety and efficacy studies required to support placebo-controlled multi-center trial is designed to an IND application, and that could be followed by enroll approximately 140 patients at leading stroke a clinical study of MultiStem for the treatment of TBI. centers
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