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athersys inc (ATHX) Key Developments

Athersys and Cell Therapy Catapult Announce Grant to Support Clinical Development of Stem Cell Therapy for Severe Acute Respiratory Condition

Athersys Limited and the Cell Therapy Catapult announced that Athersys Limited has been awarded a grant from Innovate UK, formerly the Technology Strategy Board, which will support a Phase 2a clinical study evaluating the administration of MultiStem® cell therapy to acute respiratory distress syndrome (ARDS) patients. ARDS is a serious immunological and inflammatory condition characterised by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, or other trauma and represents a major cause of morbidity and mortality in the critical care setting. It has significant implications, as it prolongs intensive care unit (ICU) and hospital stays, and requires convalescence in the hospital and rehabilitation. There are limited interventions and no effective drug treatments for ARDS, making it an area of high unmet clinical need with high treatment costs. Given ARDS high treatment costs, a successful cell therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator, days in the ICU and total days in the hospital, and importantly, could reduce mortality and improve quality of life for those suffering from the condition. The medical need for a safe and effective treatment of ARDS is significant due to its high mortality rate, and it affects annually approximately 33,000 patients in the UK and 400,000 - 500,000 patients in Europe, the United States and Japan, alone. MultiStem cell therapy has demonstrated the capacity to reduce inflammation, support tissue regeneration and promote homeostasis in acute immunological and injury settings. Preclinical data suggests that MultiStem cells may have a protective effect by shifting the physiological response from pro-inflammatory to anti-inflammatory. In animal models, MultiStem cells have demonstrated an ability to reduce the severity of pulmonary distress, reduce alveolar edema and return lung endothelial permeablity to normal. Intravenous MultiStem treatment early following the onset of the condition may ameliorate the initial hyper-inflammation and reduce the fibrotic activity that follows, thereby speeding the return to and improving the likelihood of more normal lung function, and helping patient recovery.

Athersys, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-12-2015

Athersys, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-12-2015 . Venue: Westin St. Francis Hotel, San Francisco, California, United States.

Athersys, Inc. Finishes Enrollment of Phase 2 Study of MultiStem(R) Cell Therapy for Ischemic Stroke

Athersys, Inc. announced that it has concluded patient enrollment of its Phase 2 clinical study involving administration of Athersys' MultiStem® cell therapy to ischemic stroke patients. The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating the safety and efficacy of MultiStem therapy in subjects suffering moderate to moderate-severe ischemic strokes. Athersys expects initial results from the study to be disclosed around the end of the first quarter of 2015. An ischemic stroke can be a devastating event for a patient, and effective treatments for stroke are limited, resulting in substantial opportunities for new therapies. Ischemic stroke is caused by a blockage of blood flow to the brain. A leading cause of death and disability globally, each year more than 15 million people are estimated to suffer a stroke, including more than two million people in the United States, Japan and European Union, combined. According to the American Heart Association, ischemic strokes comprise more than 85% of all strokes. Current standard of care for ischemic stroke involves the administration of a thrombolytic (clot dissolving) agent within three to four hours after a stroke has occurred, a narrow window that results in only a small percentage of patients receiving such treatment. In this Phase 2 trial, stroke victims were administered MultiStem cells or placebo intravenously one to two days after the stroke had occurred. If this study shows that MultiStem treatment is both safe and effective following such administration, as was demonstrated in non-clinical studies, the treatment window could be expanded significantly, from hours to days, providing an important new therapeutic option for stroke patients. Based on preclinical studies, Athersys believes that MultiStem treatment has the potential to substantially improve neurological and functional recovery following stroke by attenuating the inflammatory activity that follows the stroke, accelerating the return to immune system homeostasis, supporting protection of at-risk neurons, and by supporting conditions for neuronal recovery and growth, thereby enhancing repair and patient recovery. The MultiStem treatment's potential multidimensional impact distinguishes the cell therapy from other pharmaceutical therapies focused on a single mechanism of benefit. The randomized, double-blind, placebo-controlled Phase 2 clinical trial is being conducted by Athersys at sites in the United States and United Kingdom, and has enrolled subjects who received either MultiStem treatment or placebo one to two days following the stroke. The primary endpoints for the study include safety over the first seven days following treatment and global stroke recovery at day 90, which assesses global disability, neurological deficit and activities of daily living. Additionally, there are multiple secondary and exploratory endpoints evaluating multiple elements of recovery and dysfunction, including biomarkers associated with the condition and recovery, and safety variables over the study period.

Athersys, Inc. Presents at 7th annual Biotech Showcase Conference 2015, Jan-13-2015 11:00 AM

Athersys, Inc. Presents at 7th annual Biotech Showcase Conference 2015, Jan-13-2015 11:00 AM. Venue: Parc 55 Wyndham San, Francisco - Union Square, San Francisco, CA 94102, United States. Speakers: William Lehmann, President, Chief Operating Officer and Secretary.

Athersys, Inc. Announces Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014

Athersys, Inc. announced unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported total revenues of $293,000 against $621,000 a year ago, reflecting primarily a decrease in grant revenue. Loss from operations was $7,268,000 against $5,604,000 a year ago. Net loss was $4,719,000 against $5,614,000 a year ago. The difference reflects the impact of a $2.5 million increase in non-cash income from the change in the fair value of warrant liabilities, less the $1.3 million aggregate increase in research and development and general and administrative expenses, and the $0.3 million decrease in revenues. Diluted net loss per share was $0.08 against $0.10 a year ago. During the nine-month period ended September 30, 2014, cash used in operating activities was $19.7 million and was $18.3 million in the comparable period of 2013.

 

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