"We believe that MultiStem cell therapy and our related technologies have great potential to help patients by improving clinical outcomes and quality of life, and reduce related healthcare costs in multiple disease areas," said
"We are pleased with the enrollment progress of our Phase 2 ischemic stroke study through the second quarter. Though rates have slowed over the last several weeks during the summer holiday period, we expect to complete enrollment within the next several months, with top-line data available three to four months after the last patient is enrolled. We believe that MultiStem therapy has the potential to greatly improve treatment outcomes for more severe stroke patients, and we look forward to the results from this trial.
"Meanwhile, we are excited about the planned initiation of our Phase 2 acute myocardial infarction study later this year and are well-along in preparation for this trial," added Dr.
"As we have previously noted, Pfizer will continue to generate information through the end of the year from the ongoing Phase 2 UC study, including additional clinical data and biomarker analyses. We look forward to receiving and evaluating this information to better understand the previously reported clinical results and the potential relevance for MultiStem therapy in this and related therapeutic areas.
"On the regulatory front, we are actively engaged in interactions to advance clinical development in several areas, including with the
Second Quarter Results
For the three months ended
Research and development expenses were
Net income for the three months ended
As of
Conference Call
As previously announced,
Date |
|
Time |
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Telephone access: U.S. and |
800-273-1254 |
Telephone access: International | 973-638-3440 |
Access code | 74126643 |
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
About
The
Forward-Looking Statements
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.
(Tables Follow)
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Condensed Consolidated Balance Sheets | ||
(In thousands) | ||
|
|
|
2014 | 2013 | |
(Unaudited) | (Note) | |
Assets | ||
Cash, cash equivalents |
|
|
Other current assets | 1,025 | 907 |
Equipment, net | 1,343 | 1,333 |
Total assets |
|
|
Liabilities and stockholders' equity | ||
Accounts payable, accrued expenses and deferred revenue |
|
|
Warrant liabilities and note payable | 5,923 | 9,999 |
Total stockholders' equity | 30,878 | 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 Share and Per Share Amounts) | ||
Three Months ended |
||
2014 | 2013 | |
(Unaudited) | ||
Revenues | ||
Contract revenue |
|
|
Grant revenue | 352 | 377 |
Total revenues | 388 | 571 |
Costs and Expenses | ||
Research and development | 5,754 | 5,107 |
General and administrative | 1,827 | 1,555 |
Depreciation | 93 | 86 |
Total costs and expenses | 7,674 | 6,748 |
Loss from operations | (7,286) | (6,177) |
Other income, net | 42 | 15 |
Income from change in fair value of warrants | 7,919 | 216 |
Net income (loss) and comprehensive income (loss) |
|
$ (5,946) |
Net income (loss) per share - Basic |
|
$ (0.11) |
Weighted average shares outstanding, basic | 77,077,492 | 56,028,461 |
Net loss per share - Diluted | $ (0.04) | $ (0.11) |
Weighted average shares outstanding, diluted | 78,778,181 | 57,841,167 |
CONTACT: William (Source:B.J.) Lehmann , J.D. President and Chief Operating Officer Tel: (216) 431-9900 bjlehmann@athersys.com Investor Relations:Lisa M. Wilson In-Site Communications Tel: (917) 543-9932 lwilson@insitecony.com
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