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News Article | May 9, 2017
Site: globenewswire.com

Company announces Fast Track Designation by FDA for Stroke Program and other progress CLEVELAND, May 09, 2017 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced its financial results for the three months ended March 31, 2017. Highlights of the first quarter of 2017 and recent events include: “We are excited about receiving Fast Track designation for our clinical stroke program, and we thank the FDA for its continued support of our efforts to develop and provide an important new treatment option for patients in this area of unmet medical need,” commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys.  “Recent publications and presentations continue to illustrate how we might be able to extend the treatment window for stroke patients out to 36 hours with MultiStem, beyond the narrow window for treatment that exists today, and also the important biological mechanisms that our cell therapy may provide to help patients recover from a debilitating stroke event.  Stroke remains the leading cause of serious disability, yet many people are still unaware of the signs and symptoms of stroke, or the need to take action right away, and we are committed to building public awareness in this area. “We are pleased that the Healios TREASURE trial in Japan is now getting underway,” added Dr. Van Bokkelen. “Additionally, we are actively engaged with the FDA, European Medicines Agency and other regulators to obtain regulatory alignment for our planned Phase 3 clinical trial for stroke, MASTERS-2, and we anticipate completing the key regulatory activities for our study sometime this summer.  In parallel, we are advancing our partnering discussions in stroke and other areas, which represent an important priority for the company,” concluded Dr. Van Bokkelen. For the three months ended March 31, 2017, revenues were $1.5 million compared to $15.5 million in the same period in 2016, reflecting the recognition of a $1.0 million commercial milestone in the first quarter of 2017 from our RTI collaboration and a $15.0 million license fee from our Healios collaboration in the first quarter of 2016.  Grant revenue remained consistent between the two quarters ended March 31.  We expect our future contract revenues to be comprised primarily of revenues associated with our Healios collaboration, royalty payments and potential commercial milestone payments from RTI, and proceeds from potential new collaborations.  Grant revenues continue to vary from period-to-period with new and completed grants, and with the timing of grant-funded projects. Research and development expenses decreased to $5.6 million in the 2017 first quarter from $6.7 million in the 2016 first quarter primarily due to decreased clinical and preclinical development costs, decreased internal research supplies, decreased license fees and decreased travel costs. General and administrative expenses were relatively consistent at $2.1 million and $2.0 million for the three months ended March 31, 2017 and 2016, respectively. Net loss was $5.6 million in 2017, compared to net income of $4.8 million in 2016.  The difference of $10.4 million reflects the above variances, as well as a $2.9 million non-cash increase in the gain related to the fair value of our warrant liabilities.  All outstanding warrants had either been exercised or expired as of March 31, 2017. Cash used in operating activities was $5.4 million during the 2017 first quarter, compared to cash provided of $7.3 million in the 2016 first quarter, with the change of $12.7 million driven primarily from collaborative payments in the three-month periods ending March 31, 2017 and 2016, respectively.  As of March 31, 2017, we had $31.9 million in cash and cash equivalents, compared to $14.8 million at December 31, 2016, which includes, among other things, the net proceeds of the common stock offering in February 2017. Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (BJ) 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 May 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 5869094. 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. 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 | May 9, 2017
Site: globenewswire.com

Company announces Fast Track Designation by FDA for Stroke Program and other progress CLEVELAND, May 09, 2017 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced its financial results for the three months ended March 31, 2017. Highlights of the first quarter of 2017 and recent events include: “We are excited about receiving Fast Track designation for our clinical stroke program, and we thank the FDA for its continued support of our efforts to develop and provide an important new treatment option for patients in this area of unmet medical need,” commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys.  “Recent publications and presentations continue to illustrate how we might be able to extend the treatment window for stroke patients out to 36 hours with MultiStem, beyond the narrow window for treatment that exists today, and also the important biological mechanisms that our cell therapy may provide to help patients recover from a debilitating stroke event.  Stroke remains the leading cause of serious disability, yet many people are still unaware of the signs and symptoms of stroke, or the need to take action right away, and we are committed to building public awareness in this area. “We are pleased that the Healios TREASURE trial in Japan is now getting underway,” added Dr. Van Bokkelen. “Additionally, we are actively engaged with the FDA, European Medicines Agency and other regulators to obtain regulatory alignment for our planned Phase 3 clinical trial for stroke, MASTERS-2, and we anticipate completing the key regulatory activities for our study sometime this summer.  In parallel, we are advancing our partnering discussions in stroke and other areas, which represent an important priority for the company,” concluded Dr. Van Bokkelen. For the three months ended March 31, 2017, revenues were $1.5 million compared to $15.5 million in the same period in 2016, reflecting the recognition of a $1.0 million commercial milestone in the first quarter of 2017 from our RTI collaboration and a $15.0 million license fee from our Healios collaboration in the first quarter of 2016.  Grant revenue remained consistent between the two quarters ended March 31.  We expect our future contract revenues to be comprised primarily of revenues associated with our Healios collaboration, royalty payments and potential commercial milestone payments from RTI, and proceeds from potential new collaborations.  Grant revenues continue to vary from period-to-period with new and completed grants, and with the timing of grant-funded projects. Research and development expenses decreased to $5.6 million in the 2017 first quarter from $6.7 million in the 2016 first quarter primarily due to decreased clinical and preclinical development costs, decreased internal research supplies, decreased license fees and decreased travel costs. General and administrative expenses were relatively consistent at $2.1 million and $2.0 million for the three months ended March 31, 2017 and 2016, respectively. Net loss was $5.6 million in 2017, compared to net income of $4.8 million in 2016.  The difference of $10.4 million reflects the above variances, as well as a $2.9 million non-cash increase in the gain related to the fair value of our warrant liabilities.  All outstanding warrants had either been exercised or expired as of March 31, 2017. Cash used in operating activities was $5.4 million during the 2017 first quarter, compared to cash provided of $7.3 million in the 2016 first quarter, with the change of $12.7 million driven primarily from collaborative payments in the three-month periods ending March 31, 2017 and 2016, respectively.  As of March 31, 2017, we had $31.9 million in cash and cash equivalents, compared to $14.8 million at December 31, 2016, which includes, among other things, the net proceeds of the common stock offering in February 2017. Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (BJ) 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 May 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 5869094. 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. 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 | May 9, 2017
Site: globenewswire.com

Company announces Fast Track Designation by FDA for Stroke Program and other progress CLEVELAND, May 09, 2017 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced its financial results for the three months ended March 31, 2017. Highlights of the first quarter of 2017 and recent events include: “We are excited about receiving Fast Track designation for our clinical stroke program, and we thank the FDA for its continued support of our efforts to develop and provide an important new treatment option for patients in this area of unmet medical need,” commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys.  “Recent publications and presentations continue to illustrate how we might be able to extend the treatment window for stroke patients out to 36 hours with MultiStem, beyond the narrow window for treatment that exists today, and also the important biological mechanisms that our cell therapy may provide to help patients recover from a debilitating stroke event.  Stroke remains the leading cause of serious disability, yet many people are still unaware of the signs and symptoms of stroke, or the need to take action right away, and we are committed to building public awareness in this area. “We are pleased that the Healios TREASURE trial in Japan is now getting underway,” added Dr. Van Bokkelen. “Additionally, we are actively engaged with the FDA, European Medicines Agency and other regulators to obtain regulatory alignment for our planned Phase 3 clinical trial for stroke, MASTERS-2, and we anticipate completing the key regulatory activities for our study sometime this summer.  In parallel, we are advancing our partnering discussions in stroke and other areas, which represent an important priority for the company,” concluded Dr. Van Bokkelen. For the three months ended March 31, 2017, revenues were $1.5 million compared to $15.5 million in the same period in 2016, reflecting the recognition of a $1.0 million commercial milestone in the first quarter of 2017 from our RTI collaboration and a $15.0 million license fee from our Healios collaboration in the first quarter of 2016.  Grant revenue remained consistent between the two quarters ended March 31.  We expect our future contract revenues to be comprised primarily of revenues associated with our Healios collaboration, royalty payments and potential commercial milestone payments from RTI, and proceeds from potential new collaborations.  Grant revenues continue to vary from period-to-period with new and completed grants, and with the timing of grant-funded projects. Research and development expenses decreased to $5.6 million in the 2017 first quarter from $6.7 million in the 2016 first quarter primarily due to decreased clinical and preclinical development costs, decreased internal research supplies, decreased license fees and decreased travel costs. General and administrative expenses were relatively consistent at $2.1 million and $2.0 million for the three months ended March 31, 2017 and 2016, respectively. Net loss was $5.6 million in 2017, compared to net income of $4.8 million in 2016.  The difference of $10.4 million reflects the above variances, as well as a $2.9 million non-cash increase in the gain related to the fair value of our warrant liabilities.  All outstanding warrants had either been exercised or expired as of March 31, 2017. Cash used in operating activities was $5.4 million during the 2017 first quarter, compared to cash provided of $7.3 million in the 2016 first quarter, with the change of $12.7 million driven primarily from collaborative payments in the three-month periods ending March 31, 2017 and 2016, respectively.  As of March 31, 2017, we had $31.9 million in cash and cash equivalents, compared to $14.8 million at December 31, 2016, which includes, among other things, the net proceeds of the common stock offering in February 2017. Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (BJ) 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 May 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 5869094. 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. 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 | May 9, 2017
Site: www.businesswire.com

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 George M. Milne, Jr., Ph.D. to its board of directors. Prior to his retirement, Dr. Milne served as Executive Vice President of Global Research and Development and President of Worldwide Strategic and Operations Management at Pfizer. Dr. Milne serves on multiple corporate boards including Charles River Laboratories where he is the lead director and Amylyx Pharmaceuticals and is Venture Partner at Radius Ventures. “George has made significant contributions to the pharmaceutical sector during his successful career. His experience in the board room will prove extremely valuable as we approach the next crucial stage of development as a company working to advance voclosporin to market while exploring potential additional indications for the compound,” said Richard M. Glickman, Chief Executive Officer of Aurinia. Dr. Milne has over 30 years of experience in pharmaceutical research and product development. He joined Pfizer in 1970 and held a variety of positions conducting both chemistry and pharmacology research. Dr. Milne became director of the department of immunology and infectious diseases at Pfizer in 1981, was its executive director from 1984 to 1985, and was vice president of research and development from 1985 to 1988. He was appointed senior vice president in 1988. In 1993 he was appointed President of Pfizer Central Research and a senior vice president of Pfizer with global responsibility for human and veterinary medicine R&D. Dr. Milne has served on multiple corporate boards including Mettler-Toledo, Inc., MedImmune, Athersys, Biostorage Technologies, Aspreva, and Conor Medsystems. Dr. Milne received his B.Sc. in Chemistry from Yale University and his Ph.D. in Organic Chemistry from MIT. "Aurinia has demonstrated its leadership in advancing a viable treatment option for patients suffering from lupus nephritis,” added George Milne. “I look forward to working alongside this exceptional team and sharing my expertise as we pursue a successful future for the company.” Additionally, the company announced that Dr. Greg Ayers has resigned from Aurinia’s board of directors, effective immediately. “On behalf of the board of directors, I thank Greg for his service and contributions and wish him well in future endeavors," added Dr. Glickman. Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical trial data in over 2,200 patients across indications. 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. Voclosporin is made by a modification of a single amino acid of the cyclosporine molecule which results in a more predictable pharmacokinetic and pharmacodynamic relationship with potential for flat dosing. In addition, Voclosporin is more potent than and has an improved metabolic profile versus cyclosporine. Aurinia 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. LN, an inflammation of the kidney caused by Systemic Lupus Erythematosus (“SLE”), represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder that 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 a strong surrogate marker, proteinuria, which correlates with meaningful longer term clinical outcome. 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. 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. Aurinia is currently developing voclosporin, an investigational drug, for the treatment of LN. Aurinia is headquartered in Victoria, BC and focuses its development efforts globally. www.auriniapharma.com. This press release contains forward-looking statements, including statements related to Aurinia’s plans to advance voclosporin to market and explore additional indications for the compound, Dr. Milne’s expected impact on Aurinia’s progress, the belief that voclosporin is a potentially best-in-class CNI and a viable treatment option for patients suffering from LN with potential to improve near- and long-term outcomes in LN, and the belief 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. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "plans," "intends," “may,” "will," "believe," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Aurinia’s current expectations. Forward-looking statements involve risks and uncertainties. Aurinia’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Aurinia’s analyses, assessment and conclusions of the results of its clinical studies may change based on further analyses, the risk that Aurinia will not successfully complete its clinical programs and the risk that Aurinia’s clinical studies for voclosporin may not lead to regulatory approval. These and other risk factors are discussed under "Risk Factors" and elsewhere in Aurinia’s Annual Information Form for the year ended December 31, 2016 filed with Canadian securities authorities and available at www.sedar.com and on Form 40-F with the U.S. Securities Exchange Commission and available at www.sec.gov, each as updated by subsequent filings, including filings on Form 6-K. Aurinia expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Aurinia's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law.


Browse 350 Tables and Figures, 17 Companies spread across 680 pages, available at http://www.reportsnreports.com/reports/974420-global-regenerative-medicine-market-analysis-forecast-to-2021-stem-cells-tissue-engineering-biobanking-car-t-industries.html . Analysis indicates that the global regenerative medicine market was worth $18.9 billion in 2016 and will grow to over $53.7 billion by 2021, with a CAGR of 23.3% between this time frame. Within this market, the stem cell industry will grow significantly at a CAGR of over x% and reach $x billion by 2021. Tissue engineering is forecast to grow at a CAGR of x% to 2021 and potentially reach $x billion. Companies Mentioned are Astellas Institute for Regenerative Medicine (Ocata Therapeutics), AstraZeneca, Athersys, Baxter International (Baxalta,  Shire), Bayer, Caladrius Biosciences (NeoStem), Celgene, CHA Biotech, Chimerix, Cynata Therapeutics, Cytori Therapeutics, Eisai, Genzyme (Sanofi), GSK, Janssen, InCyte Corp, MedImmune, MEDIPOST, Merck, Mesoblast, Millennium Pharmaceutical, NuVasive, Osiris Therapeutics, Plasticell, Pluristem Therapeutics, Pfizer, SanBio Current Stem Cell Trials, Seattle Genetics Current Stem Cell Trials, StemCells Inc, STEMCELL Technologies, Takara Bio, Teva Current Stem Cell Trials and Tigenix This report describes the evolution of such a huge market in 15 chapters, which provides an overview of regenerative medicine that includes: stem cells, allogenic and autogenic cells, umbilical cord blood banking, tissue engineering and CAR T therapies. Global regenerative medicine market, global breakdown, application breakdown and leading market players. Detailed account of the stem cell industry market by geography, indication and company profiles. Profiles, marketed/pipeline products, financial analysis and business strategy of the major companies in this space. Focus on current trends, business environment, pipeline products, clinical trials, and future market forecast for regenerative medicine. Insight into the challenges faced by stakeholders, particularly about the success vs. failure ratios in developing regenerative medicine drugs and therapies. Insight into the biobanking industry globally and its impact on the overall market. Description and data for the prevalence of disease types that are addressed by regenerative medicine, stem cells, tissue engineering and CAR-T therapies. Financial market forecast through 2021 with CAGR values of all market segments outlined in the objective. SWOT analysis of the global market. Geographical analysis and challenges within key topographies including the USA, Japan, South Korea, China and Europe Looking forward, the regenerative medicine market is promising for a number of robust reasons including: There are over 700 regenerative medicine companies globally at present, that all together have a $x billion market cap. At present the total regenerative medicine market has more than 500 products commercialized.  The regenerative medicine market encompasses a number of key technology submarkets including: Cell therapy including stem cells, Tissue Engineering, Biomaterials and BioBanking Regenerative medicine, including cellular and gene therapies will have a significant impact on the expenditure of payers, once reimbursement schemes are optimized. To that end a number of conditions that regenerative medicine tackles is synonymous with an aging population such as The report further provides: Global Regenerative Market by Manufacturers, Regions, Type and Application, Forecast to 2021 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market to 2021- Strategic Analysis of Industry Trends, Technologies, Participants, and Environment Large Cap Pharma US & EU Outlook 2016: Maximizing Their Strength On Fewer Therapy Class, Personalized Medicine, Novel Target And Biosimilars For Future Growth Explore more reports on Biotechnology Market at http://www.reportsnreports.com/market-research/biotechnology/. ReportsnReports.com is an online market research reports library of 500,000+ in-depth studies of over 5000 micro markets. Not limited to any one industry, ReportsnReports.com offers research studies on agriculture, energy and power, chemicals, environment, medical devices, healthcare, food and beverages, water, advanced materials and much more.


Browse 350 Tables and Figures, 17 Companies spread across 680 pages, available at http://www.reportsnreports.com/reports/974420-global-regenerative-medicine-market-analysis-forecast-to-2021-stem-cells-tissue-engineering-biobanking-car-t-industries.html . Analysis indicates that the global regenerative medicine market was worth $18.9 billion in 2016 and will grow to over $53.7 billion by 2021, with a CAGR of 23.3% between this time frame. Within this market, the stem cell industry will grow significantly at a CAGR of over x% and reach $x billion by 2021. Tissue engineering is forecast to grow at a CAGR of x% to 2021 and potentially reach $x billion. Companies Mentioned are Astellas Institute for Regenerative Medicine (Ocata Therapeutics), AstraZeneca, Athersys, Baxter International (Baxalta,  Shire), Bayer, Caladrius Biosciences (NeoStem), Celgene, CHA Biotech, Chimerix, Cynata Therapeutics, Cytori Therapeutics, Eisai, Genzyme (Sanofi), GSK, Janssen, InCyte Corp, MedImmune, MEDIPOST, Merck, Mesoblast, Millennium Pharmaceutical, NuVasive, Osiris Therapeutics, Plasticell, Pluristem Therapeutics, Pfizer, SanBio Current Stem Cell Trials, Seattle Genetics Current Stem Cell Trials, StemCells Inc, STEMCELL Technologies, Takara Bio, Teva Current Stem Cell Trials and Tigenix This report describes the evolution of such a huge market in 15 chapters, which provides an overview of regenerative medicine that includes: stem cells, allogenic and autogenic cells, umbilical cord blood banking, tissue engineering and CAR T therapies. Global regenerative medicine market, global breakdown, application breakdown and leading market players. Detailed account of the stem cell industry market by geography, indication and company profiles. Profiles, marketed/pipeline products, financial analysis and business strategy of the major companies in this space. Focus on current trends, business environment, pipeline products, clinical trials, and future market forecast for regenerative medicine. Insight into the challenges faced by stakeholders, particularly about the success vs. failure ratios in developing regenerative medicine drugs and therapies. Insight into the biobanking industry globally and its impact on the overall market. Description and data for the prevalence of disease types that are addressed by regenerative medicine, stem cells, tissue engineering and CAR-T therapies. Financial market forecast through 2021 with CAGR values of all market segments outlined in the objective. SWOT analysis of the global market. Geographical analysis and challenges within key topographies including the USA, Japan, South Korea, China and Europe Looking forward, the regenerative medicine market is promising for a number of robust reasons including: There are over 700 regenerative medicine companies globally at present, that all together have a $x billion market cap. At present the total regenerative medicine market has more than 500 products commercialized.  The regenerative medicine market encompasses a number of key technology submarkets including: Cell therapy including stem cells, Tissue Engineering, Biomaterials and BioBanking Regenerative medicine, including cellular and gene therapies will have a significant impact on the expenditure of payers, once reimbursement schemes are optimized. To that end a number of conditions that regenerative medicine tackles is synonymous with an aging population such as The report further provides: Global Regenerative Market by Manufacturers, Regions, Type and Application, Forecast to 2021 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market to 2021- Strategic Analysis of Industry Trends, Technologies, Participants, and Environment Large Cap Pharma US & EU Outlook 2016: Maximizing Their Strength On Fewer Therapy Class, Personalized Medicine, Novel Target And Biosimilars For Future Growth Explore more reports on Biotechnology Market at http://www.reportsnreports.com/market-research/biotechnology/. ReportsnReports.com is an online market research reports library of 500,000+ in-depth studies of over 5000 micro markets. Not limited to any one industry, ReportsnReports.com offers research studies on agriculture, energy and power, chemicals, environment, medical devices, healthcare, food and beverages, water, advanced materials and much more.

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