William (B.J.) Lehmann, J.D. | Investor Relations:Lisa M. Wilson | Media:Dave Buckalew | ||
President and COO | In-Site Communications | Lambert, Edwards & Associates | ||
Tel: (216) 431-9900 | Tel: (917) 543-9932 | Tel: (616) 233-0500 | ||
bjlehmann@athersys.com | lwilson@insitecony.com | dbuckalew@lambert-edwards.com |
—MultiStem Programs and Pipeline Continue to Advance—
• | Ongoing enrollment in two MultiStem® phase I clinical trials, for the treatment of acute myocardial infarction (AMI) and the complications, including graft-versus-host disease (GVHD), associated with bone marrow and peripheral blood stem cell transplants for treating leukemia and related cancers; |
• | Suspended the development of ATHX-105, ceasing further expenditures on this program; |
• | Concluded an agreement with Bristol-Myers Squibb extending our discovery collaboration through the end of 2009; |
• | Awarded with our collaborators in the Center for Stem Cells and Regenerative Medicine a significant grant from the State of Ohio’s Biomedical Research and Commercialization Program, which will support the further development of MultiStem; |
• | Revenues of $370,000 and a net loss of $3.6 million were recorded for the quarter ended March 31, 2009; |
• | Completed the quarter with $28.3 million in cash, cash equivalents and available-for-sale securities. |
“In the first quarter of 2009, we continued to advance the development of our MultiStem platform with clinical programs for the treatment of AMI and for cancer treatment support in patients at risk for GVHD and other complications. We have now successfully completed our first dosing cohort in both trials and recently began enrolling patients in the second dosing cohort for the AMI study. We are focused on adding clinical sites, increasing enrollment rates and are also making preparations that would enable us to initiate our third phase I trial involving MultiStem administration to patients who have suffered an ischemic stroke, subject to obtaining grant funding or finding a partner for this important program,” said Gil Van Bokkelen, Ph.D., Chairman and Chief Executive Officer. “Our goal will be to meaningfully advance these and other programs throughout the remainder of the year, while we continue to actively explore partnering opportunities. Our cash position is strong, and we will continue to be prudent as we utilize these resources to advance our core programs.”
Revenues for the three months ended March 31, 2009 decreased to $370,000 from $792,000 for the comparable period in 2008, due principally to a decrease in grant revenues and license fees during the period. Research and development expenses decreased to $2.6 million for the three months ended March 31, 2009 from $4.3 million for the comparable period in 2008, related primarily to a decrease in clinical and preclinical development costs associated with the ATHX-105 clinical program that was suspended early in 2009. General and administrative expenses were $1.5 million for the three months ended March 31, 2009 and 2008. Interest income decreased to $128,000 during the three months ended March 31, 2009 from $459,000 for the comparable period in 2008 due to the decrease in the Company’s cash balances.
As of March 31, 2009, cash, cash equivalents and available-for-sale securities totaled $28.3 million.
Outlook for 2009
During 2009, the Company plans to continue to advance its phase I clinical trials evaluating MultiStem for the treatment of cardiovascular disease and the complications (e.g., GVHD) associated with bone marrow or hematopoietic stem cell transplantation therapy often used in the oncology area. Depending on the Company’s success in securing external funding through business partnerships or grants, it may initiate clinical development in other disease areas, such as the treatment of ischemic stroke. Though the Company is focused on exploring potential partnering opportunities across each of its key programs, it believes that its available cash should be adequate to fund its operations through 2011 based on current business and operating plans, even without a new financing or business partnership.
Additional Details of Key Programs and Recent Highlights
Progress on three MultiStem® INDs
During 2008, the Company advanced two MultiStem programs into clinical development, initiating phase I safety studies in cardiovascular disease (treating patients that have suffered an acute myocardial infarction) and in oncology treatment support (administering MultiStem to leukemia or lymphoma patients who are receiving a traditional bone marrow or hematopoietic stem cell transplant to reduce the risk or severity of GVHD). In December 2008, the FDA granted authorization to initiate a third clinical study, administering MultiStem for the treatment of ischemic stroke, for which the Company is actively pursuing a business partnership.
The Company believes that MultiStem represents a significant advancement in stem cell therapy based on research and development to date. Specifically, based on work performed to date, MultiStem:
• | does not require traditional tissue matching or require supplemental immune suppressive drugs; |
• | may be produced on a large scale, in a well validated and reproducible manner; and |
• | is safe and capable of delivering therapeutic benefits in multiple ways, such as the reduction of inflammation, protection of damaged or injured tissue, and the formation of new blood vessels in ischemic injury. |
In April 2009, the Company and other collaborators at the Center for Stem Cells and Regenerative Medicine (CSCRM) were awarded a $5 million grant from the State of Ohio’s Biomedical Research and Commercialization Program to support translational cell therapy programs utilizing MultiStem and other technologies. Partners included in the CSCRM consortium are the Cleveland Clinic, University Hospitals, Case Western Reserve University, the Ohio State University and Athersys, as well as other organizations. Approximately $800,000 of the funding is directly aimed at supporting activities at the Company involving administration of MultiStem in the oncology and pulmonary areas.
Histamine H3 Receptor Antagonist Program
In addition to the stem cell and regenerative medicine programs at the Company, Athersys is also developing H3 antagonists or inverse agonists to treat certain disorders that affect attention, cognition or wakefulness. Potential applications of such compounds includes attention-deficit disorder, epilepsy, schizophrenia, and sleep related conditions such as narcolepsy, excessive daytime sleepiness, or chronic fatigue associated with various disease conditions. The H3 receptor regulates levels of histamine and other neuro-transmitters in certain areas of the brain that play a direct role in regulating cognitive functions and wakefulness. The histamine H3 receptor antagonists being developed at Athersys represent a new class of drugs that could have an improved efficacy and safety profile relative to existing drugs used for the treatment of a range of conditions that affect attention, cognition or wakefulness.
5HT2c Agonist Program
In addition to its other programs, Athersys is developing potent, selective 5HT2c receptor agonists for the treatment of obesity. The 5HT2c serotonin receptor plays an important role in the regulation of appetite, and numerous prior studies have demonstrated that stimulation of the 5HT2c receptor causes a significant reduction in appetite, resulting in weight loss over time. Although the Company suspended the further development of its ATHX-105 program, the Company has gained a significant amount of knowledge around the 5HT2c receptor and is currently focused on the advancement of next generation compounds that exhibit improved characteristics while it also explores potential partnerships for the program.
RAGE Technology
In April 2009, the Company executed an agreement with Bristol-Myers Squibb extending through the end of 2009 its collaboration to prepare and deliver validated drug targets for use by Bristol-Myers Squibb in its drug discovery efforts and to provide for the possibility of delivering targets in the future. Beyond 2009, the Company anticipates that Bristol-Myers Squibb’s demand for new targets may be reduced, or cease altogether. The Company remains entitled to receive license fees for targets delivered to Bristol-Myers Squibb, as well as milestone payments and royalties on compounds developed by Bristol-Myers Squibb using its technology.
Conference Call
As previously announced, the Company will host a conference call today at 4:30 p.m. (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. Investors and other interested parties are invited to listen to the conference call by dialing 800-273-1254 in the U.S. and Canada, 706-679-8592 from abroad, or via a live Internet broadcast on the Company’s website at www.athersys.com under the Investor Relations section.
March 31, | December 31, | |||||||
2009 | 2008 | |||||||
(Unaudited) | (Note) | |||||||
Assets | ||||||||
Cash, cash equivalents and available-for-sale securities | $ | 28,333 | $ | 31,613 | ||||
Other current assets | 1,212 | 1,091 | ||||||
Equipment, net | 666 | 701 | ||||||
Other long-term assets | 471 | 472 | ||||||
Total assets | $ | 30,682 | $ | 33,877 | ||||
Liabilities and stockholders’ equity | ||||||||
Accounts payable and accrued expenses | $ | 2,284 | $ | 2,314 | ||||
Total stockholders’ equity | 28,398 | 31,563 | ||||||
Total liabilities and stockholders’ equity | $ | 30,682 | $ | 33,877 | ||||
Three Months ended March 31, | ||||||||
2009 | 2008 | |||||||
(Unaudited) | ||||||||
Revenues | ||||||||
License fees | $ | 188 | $ | 390 | ||||
Grant revenue | 182 | 402 | ||||||
Total revenues | 370 | 792 | ||||||
Costs and Expenses | ||||||||
Research and development | 2,611 | 4,315 | ||||||
General and administrative | 1,453 | 1,481 | ||||||
Depreciation | 59 | 57 | ||||||
Total costs and expenses | 4,123 | 5,853 | ||||||
Loss from operations | (3,753 | ) | (5,061 | ) | ||||
Interest income and other | 128 | 459 | ||||||
Interest expense | — | (62 | ) | |||||
Net loss | $ | (3,625 | ) | $ | (4,664 | ) | ||
Basic and diluted net loss per share | $ | (0.19 | ) | $ | (0.25 | ) | ||
Weighted average shares outstanding, basic and diluted | 18,927,988 | 18,927,988 |