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VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced the appointment of Lorin Jeffry “Jeff” Randall to its board of directors and Chairman of the Audit Committee. Mr. Randall currently serves on the boards of directors of Athersys, Inc. where he serves as Chairman of the Audit and Compensation Committees, and Acorda Therapeutics, Inc. where he serves on the Audit, Compliance and Nominations and Governance Committees. “ We’re at a critical inflection point for the Company and having Jeff’s expertise on the board and serving as Chairman of the Audit Committee will be extremely valuable as we work to advance voclosporin to market,” commented Charles Rowland, Chief Executive Officer of Aurinia. Mr. Randall has over 30 years of experience serving in financial and operating roles spanning biotechnology, pharmaceuticals and manufacturing. He has led a number of companies through multi-million dollar financings and mergers and acquisitions. In addition to his current board positions, Mr. Randall served on the board of directors of Nanosphere, Inc. from 2008 to 2016, most recently as Chairman of the Board. From 2004 to 2006, Mr. Randall, a financial consultant, was Senior Vice President and Chief Financial Officer of Eximias Pharmaceutical Corporation, a development-stage drug development company. Mr. Randall holds a Bachelor’s of Science in Mathematics and Accounting from Pennsylvania State University and a Master’s in Business Administration from Northeastern University. " This is an especially exciting time for Aurinia," added Jeff Randall. " I look forward to working with the accomplished Aurinia team in developing innovative treatments to improve long-term outcomes for patients living with debilitating and potentially life threatening diseases, such as lupus nephritis." About Voclosporin Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,000 patients across indications. The drug has received “Fast Track Designation” from the U.S. FDA. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing. The Company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries. About Lupus Nephritis (LN) Lupus Nephritis (LN) in an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder and affects more than 500,000 people in the United States (mostly women). The disease is highly heterogeneous, affecting a wide range of organs & tissue systems. It is estimated that as many as 60% of all SLE patients have clinical LN requiring treatment. Unlike SLE, LN has straightforward disease outcomes where an early response correlates with long-term outcomes, measured by proteinuria. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (eGFR), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition. About Aurinia Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The Company is currently developing voclosporin, an investigational drug, for the treatment of lupus nephritis (LN). The Company is headquartered in Victoria, BC and focuses its development efforts globally. www.auriniapharma.com.


News Article | December 7, 2016
Site: marketersmedia.com

According to Stratistics MRC, the Regenerative Medicine Market is estimated at $20.07 billion in 2015 and is projected to reach $101.3 billion by 2022 growing at a CAGR of 26.0% from 2015 to 2022. Growing research applications, growing demand in tissue engineering, biomaterials and stem cell therapy systems are some of the factors driving the market growth. However, high cost associated with biomaterials will be a major factor to restrict the market growth. The stem cells application and advancements in nanotechnology will further drive the market over the forecast period. Gene therapies segment is expected to be the fastest emerging technology due to tremendous potential of gene therapy in minimizing immune rejections, which commonly occur after transplantations. Asia-Pacific would be the fastest growing region for regenerative medicine market. Europe and North America together accounted for over 3/4th of the market revenue and anticipated to be most profitable regional market. Some of the key players in the market include Shire Pharmaceuticals, Advanced Cell Technology, Inc, Genzyme, Athersys, Inc., Kinetic Concepts, Inc., NuVasive Inc., Stem cells, Inc., Cytori Therapeutics, Inc., Cytomedix Inc., Mesoblast Ltd. , Zimmer Holdings, Inc., Orthofix, DePuy Synthes Inc., Cell Medica and CryoLife. Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements For more information, please visit https://www.wiseguyreports.com/sample-request/456590-regenerative-medicine-global-market-outlook-2015-2022


CLEVELAND, Feb. 23, 2017 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) announced today a presentation featuring its MultiStem® cell therapy treatment for ischemic stroke at the International Stroke Conference 2017 this week in Houston. Dr. Kiyohiro Houkin, Professor and Chairman at Department of Neurosurgery of Hokkaido University Graduate School of Medicine, and Director of Hokkaido University Hospital, will present an overview of the Treatment Evaluation of Acute Stroke Using Regenerative Cell Elements (TREASURE) study, which is the Phase II/III trial of MultiStem (HLCM051) being conducted by HEALIOS K.K. in Japan. Athersys and Healios entered into a license agreement in January 2016 and have been collaborating on the development and commercialization of MultiStem for the treatment of stroke in Japan. Athersys completed a Phase II clinical study (MASTERS-1) of its proprietary MultiStem cell therapy for the treatment of ischemic stroke and is currently preparing for a registrational Phase III study that will be conducted in the U.S., Europe and Canada. Dr. Houkin’s presentation entitled, Treatment Evaluation of Acute Stroke Using Regenerative Cell Elements (TREASURE): A Randomized Controlled Phase II/III Trial of MultiStem (HLCM051), will take place during the session beginning at 6:15 PM CST today at the George R. Brown Convention Center, Hall E. “We are very excited to be commencing this clinical trial at Hokkaido University Hospital and then at other leading stroke centers across Japan,” said Dr. Houkin. “The need for safe, effective and clinically-practical treatments for ischemic stroke patients has never been greater. Based on the clinical results from the recently completed MASTERS-1 Phase II clinical study, many believe that innovative treatments like MultiStem cell therapy hold great promise for treating the devastating effects of a stroke and helping patients recover more effectively. Given the rapidly expanding aging population both in Japan and globally, safe and effective treatments that can reach a greater number of stroke victims could make a significant difference for many patients and their families.” In conjunction with the ISC 2017 conference, Athersys also announced an informational video featuring former NFL player and stroke survivor Tedy Bruschi. Available for viewing at https://www.youtube.com/user/AllianceRegenMed, the video focuses on the potential of increasing the post-ischemic stroke treatment window while chronicling the challenges facing doctors with today’s limited options. CBS broadcaster Solomon Wilcots moderates the video that includes stories of both Bruschi and a Houston stroke survivor who participated in the MASTERS-1 study. The International Stroke Conference is the world’s premier meeting dedicated to the science and treatment of cerebrovascular disease. Clinical Sessions focus on community risk factors; emergency care; acute neuroimaging; acute endovascular and acute nonendovascular treatment; diagnosis of stroke etiology; cerebral large artery disease; in-hospital treatment; clinical rehabilitation and recovery; and health services, quality improvement, and patient-centered outcomes. Basic Science Sessions focus on vascular biology in health and disease; basic and preclinical neuroscience of stroke recovery; and experimental mechanisms and models. Further specialized topics include pediatric stroke; intracerebral hemorrhage; nursing; preventive strategies; vascular cognitive impairment; aneurysms; subarachnoid hemorrhage; neurocritical care; vascular malformations; and ongoing clinical trials. Presentations on these topics attract a wide range of healthcare professionals and investigators including adult and pediatric neurologists; neurosurgeons; neuroradiologists and interventional radiologists; physiatrists; emergency medicine specialists; primary care physicians; hospitalists; nurses and nurse practitioners; rehabilitation specialists; physical, occupational, and speech therapists; pharmacists; and basic researchers spanning the fields of cerebrovascular function and disease. MultiStem cell therapy is a patented regenerative medicine product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors produced in response to signals of inflammation and tissue damage.  MultiStem therapy’s potential for multidimensional therapeutic impact distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. The product represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon its efficacy profile, its novel mechanisms of action, and a favorable and consistent safety profile demonstrated in both preclinical and clinical settings, MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need. Athersys has forged strategic partnerships and a broad network of collaborations to develop MultiStem cell therapy for a variety of indications, with an initial focus in the neurological, cardiovascular and inflammatory and immune disorder areas. Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, cardiovascular, inflammatory and immune disease areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions to further develop its platform and products. More information is available at www.athersys.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," “suggest,” "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, such as the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of ischemic stroke, acute myocardial infarction, spinal cord injury and acute respiratory distress syndrome and other disease indications, including graft-versus-host disease. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the success of our collaboration with Healios and others, including our ability to reach milestones and receive milestone payments, and whether any products are successfully developed and sold so that we earn royalty payments; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements; the success of our efforts to enter into new strategic partnerships or collaborations and advance our programs; our ability to raise additional capital; results from our MultiStem ongoing and planned clinical trials, including the MASTERS-2 Phase 3 clinical trial and the Healios TREASURE clinical trial in Japan; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials within the expected time frame or at all; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.


News Article | November 16, 2016
Site: www.newsmaker.com.au

The report provides comprehensive information on the therapeutics under development for Obesity, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Obesity and features dormant and discontinued projects. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Complete report on Obesity - Pipeline Review, H2 2016 addition with 170 market data tables and 17 figures, spread across 537 pages is available at http://www.reportsnreports.com/reports/747718-obesity-pipeline-review-h2-2016.html This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis Abeome Corporation,Acylin Therapeutics Inc,Advinus Therapeutics Ltd,Aegis Therapeutics, LLC,Akron Molecules AG,Alize Pharma SAS,Amabiotics SAS,Amgen Inc. ,Aoxing Pharmaceutical Company, Inc,Arena Pharmaceuticals, Inc.,AstraZeneca Plc,Asubio Pharma Co., Ltd.,Athersys, Inc.,Biophytis SAS,BioRestorative Therapies, Inc.,Boehringer Ingelheim GmbH,Braasch Biotech LLC,C3 Jian, Inc ,Carmot Therapeutics Inc,Chronos Therapeutics Limited,CohBar, Inc. ,CoMentis, Inc.,Connexios Life Sciences Pvt. Ltd.,Corium International, Inc.,Daiichi Sankyo Company, Limited,Diabetica Limited,DiscoveryBiomed, Inc.,Eli Lilly and Company,Esperion Therapeutics, Inc.,Eternygen GmbH Inquire before buying http://www.reportsnreports.com/contacts/inquirybeforebuy.aspx?name=747718(This is a premium report price at US$2000 for a single user PDF license).


News Article | November 16, 2016
Site: www.newsmaker.com.au

The report provides comprehensive information on the therapeutics under development for Schizophrenia, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Schizophrenia and features dormant and discontinued projects. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Complete report on Schizophrenia - Pipeline Review, H2 2016 addition with 118 market data tables and 17 figures, spread across 349 pages is available at http://www.reportsnreports.com/reports/747736-schizophrenia-pipeline-review-h2-2016.html This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis Alkermes Plc ,Angita B.V. ,Astellas Pharma Inc. ,Athersys, Inc. ,Avanir Pharmaceuticals, Inc.,Avineuro Pharmaceuticals, Inc.,BCWorld Pharm Co. Ltd.,BioCrea GmbH BioHealthonomics Inc ,Boehringer Ingelheim GmbH,Braeburn Pharmaceuticals, Inc.,Bristol-Myers Squibb Company,Critical Pharmaceuticals Limited,Curemark, LLC ,Delpor, Inc. ,Denovo Biopharma, LLC,Echo Pharmaceuticals,B.V.,Egis Gyogyszergyar Nyrt,Evotec AG ,F. Hoffmann-La Roche Ltd.,Fabre-Kramer Pharmaceuticals, Inc. Inquire before buying http://www.reportsnreports.com/contacts/inquirybeforebuy.aspx?name=747736this is a premium report price at US$2000 for a single user PDF license).


News Article | November 3, 2016
Site: globenewswire.com

CLEVELAND, Nov. 03, 2016 (GLOBE NEWSWIRE) -- Athersys, Inc. (NASDAQ:ATHX) announced today that Gil Van Bokkelen, Chairman and CEO, will present at the Stifel 2016 Healthcare Conference at the Lotte New York Palace Hotel in New York.  The presentation is scheduled for Wednesday, November 16, 2016 at 3:45 pm ET in the Garrison conference room. A live audio webcast will be available via the investor relations page of the Athersys website at www.athersys.com. A replay of the presentation will be archived on the Athersys website for those unable to listen live. Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions to further develop its platform and products. More information is available at www.athersys.com.


News Article | November 9, 2016
Site: globenewswire.com

CLEVELAND, Nov. 09, 2016 (GLOBE NEWSWIRE) -- Athersys, Inc. (NASDAQ:ATHX) today announced its financial results for the three months ended September 30, 2016. Highlights of the third quarter of 2016 and recent events include: “During the third quarter, we achieved two very important regulatory milestones that support our progression into late stage clinical development and towards commercialization. Most notably, the agreement with the FDA on the conduct of a pivotal study under a SPA is a significant achievement, since it defines a clear and efficient path forward for the development of MultiStem for the treatment of ischemic stroke patients. We remain actively engaged with international regulators, as well as focused on other important activities in anticipation of this important study,” said Dr. Gil Van Bokkelen, Chairman & CEO of Athersys, Inc. “We believe that success in this next development phase will put us in a position to deliver a safe, effective and practical therapy for stroke victims, with the potential to advance and redefine stroke care as we know it. “In addition, over the past few months, we have worked closely with our partner in Japan to obtain acceptance from the PMDA for the conduct in Japan of a confirmatory clinical trial under the new accelerated regulatory framework for regenerative medicine therapies, and we are pleased that Healios is now in a position to move forward with that important study. Stroke is an urgent and growing public health threat in Japan, which is experiencing one of the most challenging demographic transitions of any developed country due to the unprecedented expansion of the elderly segment of the population,” he continued. “In addition to the important progress on our stroke program, we continue to focus on the achievement of our other goals, including exploring additional partnering opportunities, advancing our process development and manufacturing related activities, and advancing our portfolio of other programs,” concluded Dr. Van Bokkelen. Our MASTERS-2 clinical trial will be a randomized, double-blind, placebo-controlled clinical trial designed to enroll 300 patients in North America and Europe who have suffered moderate to moderate-severe ischemic stroke.  The enrolled subjects will receive either a single intravenous dose of MultiStem cell therapy or placebo, administered within 18-36 hours of the occurrence of the stroke, in addition to the standard of care. The primary endpoint will evaluate disability using modified Rankin Scale (mRS) scores at three months, comparing the distribution, or the “shift,” between the MultiStem treatment and placebo groups. The mRS shift analysis evaluates patient improvement across the full disability spectrum, enabling recognition of improvements in disability and differences in mortality and other serious outcomes, among strokes of different severities. The study will also assess Excellent Outcome (the achievement of mRS ≤1, NIHSS ≤1, and Barthel Index ≥95, representing the three major indices of functional assessments for stroke patients) at three months and one year as key secondary endpoints.  Additionally, the study will consider other measures of functional recovery, biomarker data and clinical outcomes, including hospitalization, mortality and life-threatening adverse events, and post-stroke complications such as infection. Healios’ planned study in Japan will be a randomized, double-blind, placebo-controlled clinical trial designed to enroll 220 patients and conducted at hospitals in Japan that have extensive experience at providing care for stroke victims.  Based on the experience from our B01-02 study, subjects enrolled in the trial will receive either a single intravenous dose of MultiStem or placebo, administered within 18–36 hours of the occurrence of the stroke, in addition to standard of care.  The primary endpoint will be the proportion of patients with an Excellent Outcome functional assessment at 90 days. For the three months ended September 30, 2016, total revenues were $0.3 million compared to $0.4 million in the same period in 2015, reflecting a decrease in grant revenues related to clinical and preclinical studies. Research and development expenses increased to $5.3 million in the 2016 third quarter from $5.1 million in the 2015 third quarter, with the variance primarily comprised of increases in personnel costs, sponsored research, research supplies and professional fees and a decrease in preclinical and clinical development costs of $0.3 million, which fluctuate from time-to-time. General and administrative expenses were $1.8 million and $1.9 million in the third quarter of 2016 and 2015, respectively. Non-cash expense from stock-based compensation was $0.7 million in both of the 2016 and 2015 third quarters. In the quarter ended September 30, 2016, our operating loss included $0.7 million of a net gain from insurance proceeds related to storm-related damage at our primary facility.  Non-cash income from the change in the fair value of our warrant liabilities was $0.2 million and $0.3 million in the third quarter of 2016 and 2015, respectively.  Finally, net loss for the three-month periods ended September 30, 2016 and 2015 was $6.0 and $6.5 million, respectively, with the net gain from insurance proceeds being the primary variance between the periods. As of September 30, 2016, we had $19.4 million in cash and cash equivalents and available-for-sale securities compared to $23.0 million at December 31, 2015.  Cash used in operating activities during the third quarter of 2016 was $5.5 million compared to $3.7 million in the third quarter of 2015, with the 2015 third quarter including a $2.0 million refund related to Japan tax withholdings.  Net loss per share was $(0.07) per share for the current three-month period ended September 31, 2016 and was $(0.08) per share for the prior three-month period ended September 31, 2015. As previously announced, Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (B.J.) Lehmann, President and Chief Operating Officer, will host a conference call today to review the results as follows: A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM (Eastern Time) on November 23, 2016 by dialing 800-585-8367 or 855-859-2056 (U.S. and Canada), or 404-537-3406, and entering access code 97839505. The archived webcast will be available for one year at the aforementioned URL. Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions to further develop its platform and products. More information is available at www.athersys.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," “suggest,” "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, such as the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for the treatment of ischemic stroke, acute myocardial infarction, acute respiratory distress syndrome and other disease indications, including graft-versus-host disease. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the timing and nature of results from our MultiStem cell therapy clinical trials, including the MASTERS-2 Phase 3 clinical trial and the Healios clinical trial in Japan; our ability to successfully initiate and complete clinical trials of our product candidates within an expected timeframe or at all; the possibility of delays in, adverse results of, and excessive costs of the development process; the productivity, reliability and availability of suppliers, including contract research and contract manufacturing organizations; our ability to raise capital to fund our operations; the success of our efforts to enter into new strategic partnerships or collaborations and advance our programs; the success of our collaboration with Healios and others, including our ability to reach milestones and receive milestone payments, and whether any products are successfully developed and sold so that we earn royalty payments; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements; our ability to protect and defend our intellectual property and related business operations, including the successful prosecution of our patent applications and enforcement of our patent rights, and operate our business in an environment of rapid technology and intellectual property development; changes in our business strategy; changes in external economic and market factors; changes in our industry's overall performance; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.


News Article | February 14, 2017
Site: globenewswire.com

CLEVELAND, Feb. 14, 2017 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) will release its year-end 2016 financial results at approximately 4:00 PM Eastern Time on Thursday, March 9, 2017, and will host a conference call shortly thereafter at 4:30 PM Eastern Time to review the results. Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (B.J.) Lehmann, President and Chief Operating Officer, will host the call as follows: A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on March 23, 2017 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 73151585. Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, cardiovascular, and inflammatory and immune disease areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions to further develop its platform and products. More information is available at www.athersys.com.


News Article | February 14, 2017
Site: globenewswire.com

CLEVELAND, Feb. 14, 2017 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) will release its year-end 2016 financial results at approximately 4:00 PM Eastern Time on Thursday, March 9, 2017, and will host a conference call shortly thereafter at 4:30 PM Eastern Time to review the results. Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (B.J.) Lehmann, President and Chief Operating Officer, will host the call as follows: A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on March 23, 2017 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 73151585. Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, cardiovascular, and inflammatory and immune disease areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions to further develop its platform and products. More information is available at www.athersys.com.


News Article | November 21, 2016
Site: marketersmedia.com

Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease (PAD). It is caused by chronic inflammatory processes associated with atherosclerosis that result in reduced blood flow to the legs, feet and hands. Symptoms include pain or numbness in feet or toes, sores, skin infections will not heal. Treatment goals for CLI include reducing the number of cardiovascular risk factors (such as quitting smoking and reduction of cholesterol), relieving pain, healing ulcers, preventing major amputation, improving quality of life and increasing survival. Report Highlights Pharmaceutical and Healthcare latest pipeline guide Critical Limb Ischemia – Pipeline Review, H2 2016, provides comprehensive information on the therapeutics under development for Critical Limb Ischemia (Cardiovascular), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. The Critical Limb Ischemia (Cardiovascular) pipeline guide also reviews of key players involved in therapeutic development for Critical Limb Ischemia and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Phase III, Phase II, Phase I, Preclinical and Discovery stages are 2, 11, 4, 12 and 1 respectively. Similarly, the Universities portfolio in Preclinical stages comprises 1 molecules, respectively.Critical Limb Ischemia. Critical Limb Ischemia (Cardiovascular) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Scope - The pipeline guide provides a snapshot of the global therapeutic landscape of Critical Limb Ischemia (Cardiovascular). - The pipeline guide reviews pipeline therapeutics for Critical Limb Ischemia (Cardiovascular) by companies and universities/research institutes based on information derived from company and industry-specific sources. - The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages. - The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities. - The pipeline guide reviews key companies involved in Critical Limb Ischemia (Cardiovascular) therapeutics and enlists all their major and minor projects. - The pipeline guide evaluates Critical Limb Ischemia (Cardiovascular) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. - The pipeline guide encapsulates all the dormant and discontinued pipeline projects. - The pipeline guide reviews latest news related to pipeline therapeutics for Critical Limb Ischemia (Cardiovascular) Reasons to buy - Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies. - Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage. - Find and recognize significant and varied types of therapeutics under development for Critical Limb Ischemia (Cardiovascular). - Classify potential new clients or partners in the target demographic. - Develop tactical initiatives by understanding the focus areas of leading companies. - Plan mergers and acquisitions meritoriously by identifying key players and it’s most promising pipeline therapeutics. - Formulate corrective measures for pipeline projects by understanding Critical Limb Ischemia (Cardiovascular) pipeline depth and focus of Indication therapeutics. - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope. - Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline. Table of Contents Table of Contents 2 List of Tables 7 List of Figures 8 Introduction 9 Global Markets Direct Report Coverage 9 Critical Limb Ischemia Overview 10 Therapeutics Development 11 Pipeline Products for Critical Limb Ischemia - Overview 11 Pipeline Products for Critical Limb Ischemia - Comparative Analysis 12 Critical Limb Ischemia - Therapeutics under Development by Companies 13 Critical Limb Ischemia - Therapeutics under Investigation by Universities/Institutes 15 Critical Limb Ischemia - Pipeline Products Glance 16 Late Stage Products 16 Clinical Stage Products 17 Early Stage Products 18 Critical Limb Ischemia - Products under Development by Companies 19 Critical Limb Ischemia - Products under Investigation by Universities/Institutes 21 Critical Limb Ischemia - Companies Involved in Therapeutics Development 22 AnGes MG, Inc. 22 Apceth GmbH & Co. KG 23 Athersys, Inc. 24 BiogenCell Ltd. 25 Caladrius Biosciences Inc 26 Cynata Therapeutics Limited 27 …Continued For more information, please visit http://www.wiseguyreports.com

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