"We look forward to several important events this year, foremost among these are reporting initial results from the Phase 2 ulcerative colitis study, and completing enrollment and reporting results of our Phase 2 ischemic stroke trial," said Dr.
Highlights of the fourth quarter and 2013 and recent events include:
"We continue to dedicate our resources to the development of MultiStem cell therapy for the treatment and prevention of diseases where there is a significant unmet medical need," continued Dr.
"In December, our partner, Pfizer, completed enrollment of the ongoing Phase 2 clinical trial of MultiStem cell therapy as a treatment for ulcerative colitis, which is a common form of inflammatory bowel disease. The initial results from this study, which we expect to be reported by early May, should provide initial insight into the potential for MultiStem cell therapy for the treatment of ulcerative colitis and Crohn's disease. Additional data from the study that will be reported later in the second quarter will also be important in our evaluation. We expect that the study will provide further information about MultiStem cell therapy administration, dosing and biological activity that could be beneficial to development in other therapeutic areas.
"Enrollment has accelerated in the final cohort of our Phase 2 clinical trial to evaluate MultiStem cell therapy administered to patients who have suffered a moderate to moderately-severe ischemic stroke, which is a program we are currently developing on our own. In contrast to currently available therapy, we are treating patients one to two days after the stroke has occurred, which we believe is a clinically practical time frame that would greatly expand the treatment window over the current standard of care, enabling many more patients to receive treatment," added Dr.
"Since November, we have strengthened our balance sheet with two successful financings, providing us with more than
"In sum, we believe we are on a path to delivering substantial long-term value for our stockholders, through the execution of well-designed, high-quality clinical programs and the advancement of existing collaborations and new partnerships," concluded Dr.
Fourth Quarter Results
For the three months ended
Research and development expenses were
Net loss for the three months ended
2013 Annual Financial Results
For the year ended
Research and development expenses increased to
Net loss for the year ended
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|Telephone access: International||973-638-3440|
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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 and cash equivalents||
|Other current assets||907||776|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||
|Warrant liabilities and note payable||9,999||2,878|
|Total stockholders' equity||19,821||20,247|
|Total liabilities and stockholders' equity||
|Note: The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date.|
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|(In thousands, except share and per share data)|
|Three months ended||Twelve months ended|
|Contract revenue||$ 390||$ 2,024||$ 755||$ 7,380|
|Costs and expenses|
|Research and development||5,112||4,935||20,484||19,636|
|General and administrative||1,553||1,253||6,065||4,753|
|Total costs and expenses||6,754||6,272||26,895||24,709|
|Loss from operations||(5,834)||(3,983)||(24,457)||(16,001)|
|Other income (expense), net||9||(307)||38||(1,138)|
|(Expense) income from change in fair value of warrants||(3,970)||1,053||(6,324)||2,404|
|Net loss||$ (9,795)||$ (3,237)||$ (30,743)||$ (14,735)|
|Basic and diluted net loss per share||$ (0.15)||$ (0.07)||$ (0.53)||$ (0.45)|
|Weighted average shares outstanding, basic and diluted||63,468,957||45,363,029||57,674,833||32,556,781|
|Other comprehensive loss:|
|Other comprehensive loss items||--||--||--||(28)|
|Comprehensive loss||$ (9,795)||$ (3,237)||$ (30,743)||$ (14,763)|
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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