"While we were disappointed by the recent failure of a single administration of MultiStem® cell therapy to demonstrate meaningful benefit at 8 weeks for a challenging patient population with chronic, advanced ulcerative colitis, we are pleased with the favorable safety and tolerability profile observed in this study, as we have seen in other studies that
Highlights of the first quarter of 2014 and recent events include:
"We believe that MultiStem cell therapy and our related technologies are differentiated in the field of regenerative medicine and offer the clinical potential to address multiple diseases and conditions where there is a significant unmet medical need," continued Dr.
"Pfizer's UC study will continue to generate data through its completion, expected later this year. Additional evaluations are forthcoming, including data about the impact from a second round of dosing for a subset of patients and longer-term secondary efficacy endpoints at 16 weeks, as well as biomarker analysis. Though these data will not change the overall outcome, the additional information may provide more insight into the factors at work and the potential relevance for MultiStem therapy in this and related therapeutic areas.
"Enrollment has progressed well in our Phase 2 study to evaluate MultiStem cell therapy in patients who have suffered a moderate to moderately-severe ischemic stroke. We believe that MultiStem has the potential to greatly improve treatment for more severe stroke patients, and we look forward to the results from this trial," added Dr.
"We believe that we have the financial resources to enable us to further progress our clinical development programs, advance our process development activities, expand our later-stage development capabilities, and facilitate productive business development discussions. That is how we intend to create substantial value for our shareholders," concluded Dr.
First Quarter Results
For the three months ended
Research and development expenses were
Net loss for the three months ended
As previously announced,
Telephone access: U.S. and
|Telephone access: International||973-638-3440|
|Live webcast||www.athersys.com, under the Investors section|
A replay will be available for on-demand listening shortly after the completion of the call until
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 inflammatory bowel disease, acute myocardial infarction, stroke and other potential indications, including lysosomal storage disorders and the prevention of graft-versus-host disease. These risks and uncertainties 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: our ability to raise additional capital; final results from our MultiStem clinical trials; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials and obtain all necessary regulatory approvals; 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 realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones under our collaboration agreements; 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 and advance our programs; 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.
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents||
|Other current assets||1,213||907|
|Liabilities and stockholders' equity|
|Accounts payable, accrued expenses and deferred revenue||
|Warrant liabilities and note payable||13,841||9,999|
|Total stockholders' equity||29,660||19,821|
|Total liabilities and stockholders' equity||
Note: The Condensed Consolidated Balance Sheet Data at
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|(In Thousands, Except Per Share Amounts)|
Three Months ended
|Costs and Expenses|
|Research and development||6,226||5,576|
|General and administrative||1,781||1,507|
|Total costs and expenses||8,096||7,168|
|Loss from operations||(7,389)||(6,842)|
|Other income, net||29||17|
|Expense from change in fair value of warrants||(4,124)||(2,563)|
|Net loss and comprehensive loss||
|Basic and diluted net loss per common share||
|Weighted average shares outstanding, basic and diluted||75,853||53,456|
CONTACT: William (
B.J.) Lehmann, J.D. President and Chief Operating Officer Tel: (216) 431-9900 firstname.lastname@example.org Investor Relations: Lisa M. Wilson In-Site CommunicationsTel: (917) 543-9932 email@example.com
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