Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
autologous cellular therapies for the treatment of severe
cardiovascular diseases, today reported operating results for the
quarter and six months ended December 31, 2010, reflecting the
recent change in the company's fiscal year end from June 30 to
December 31. These results will be included in a new Form 10-K for
this six month transition period, which the company plans to file
in March.
"As a result of our recent financing and clinical progress, we
ended 2010 in a strong position to advance our critical limb
ischemia program into Phase 3 and complete our Phase 2 clinical
program in dilated cardiomyopathy," said Tim Mayleben, president
and CEO of Aastrom Biosciences. "We have an ambitious agenda for
the year ahead. We plan to report final results from the ongoing
Phase 2 CLI study during the second quarter, launch the first of
two Phase 3 studies in CLI mid-year, report interim data from the
IMPACT-DCM study and complete the ongoing Phase 2 Catheter DCM
trial in the third quarter and launch the next phase of clinical
testing in DCM by the end of the year."
Operating Results for the Quarter and Six Months Ended December
31, 2010
As of December 31, 2010, the company had a total of $31.2
million in cash and cash equivalents, compared to $14.7 million in
cash and cash equivalents at December 31, 2009. The increase in
cash is attributable to financings completed in January and
December 2010.
Revenues for the quarter and six month period ended December 31,
2010 was $253,000, compared to $16,000 and $89,000 for the same
periods in 2009. This increase relates to the receipt of the
Qualified Therapeutic Discovery Tax Credit received in
November.
Research and development expenses for the quarter and six month
period ended December 31, 2010 was $4.4 million and $8.6 million,
versus $3.3 million and $6.2 million for the same periods a year
ago. The increase in R&D expenses for both periods was
primarily attributable to Phase III preparation for our CLI
indication.
General and administrative expenses for the quarter and six
month period ended December 31, 2010 was $1.6 and $3.3 million,
compared to $1.3 million and $2.3 million for the same periods a
year ago. The increase in G&A expenses for both periods is
primarily due to expenses associated with non-cash stock based
compensation and consulting.
Other income (expense) for the quarter and six months ended
December 31, 2010 was $(7.6) million and $(7.7) million
respectively, compared to $0.3 million for both the quarter and six
month periods a year ago. The expense in 2010 is predominantly due
to the non-cash increase in fair value of outstanding warrants,
including those issued in the December financing, driven by the
increased fair market value of our common stock during these
periods.
Net loss for the quarter and six months ended December 31, 2010
was $13.3 million, or $0.44 per share, and $19.3 million, or $0.66
per share, compared to a net loss of $4.3 million, or $0.20 per
share, and $8.1 million, or $0.38 per share, for the same periods a
year ago. The increase in net loss for these periods is primarily
due to increased expense related to warrants. Loss per share
comparisons were also impacted by the issuance of 10 million shares
of common stock in December 2010 and 6.5 million shares of common
stock issued in January 2010.
Aastrom Conference Call Information
Tim M. Mayleben, president and chief executive officer, Scott C.
Durbin, chief financial officer, and Dr. Sharon Watling, Vice
President of Clinical and Regulatory, will host a conference call
to review and discuss operating results for the quarter and fiscal
year ended December 31, 2010 at 4:30 p.m. (ET) today, February 28,
2011. Interested parties should call toll-free (877) 312-5881,
or from outside the U.S. (253) 237-1173, and reference Aastrom's
quarter and year-end conference call. The call will include a
slide presentation and be available live in the Investors section
of Aastrom's website at http://www.aastrom.com/investor.cfm.
Please access the site at least 15 minutes prior to the
scheduled start time in order to download the required audio
software if necessary (RealPlayer or Windows Media Player). A
replay of the call will be available at 7:30 p.m. (ET) on February
28, 2011 until 11:59 p.m. (ET) on March 13, 2011, by calling (800)
642-1687, or from outside the U.S. at (706) 645-9291. A podcast
will be available after the live event at
http://www.aastrom.com/events.cfm until 11:59 a.m. (ET) on May 10,
2011. The conference ID is 46976226.
Aastrom will also hold a Special Meeting of Shareholders on
Monday, March 21, 2011 at 11:00 a.m. (ET) to approve an amendment
to the company's Restated Articles of Incorporation to increase the
number of authorized shares of common stock and an amendment to the
company's 2009 Omnibus Equity Incentive Plan to increase the number
of shares authorized for issuance. Proxy materials and information
about the meeting can be accessed at www.proxyvote.com.
About Aastrom Biosciences
Aastrom Biosciences is developing expanded autologous cellular
therapies for use in the treatment of severe, chronic
cardiovascular diseases. The company's proprietary cell-processing
technology enables the manufacture of mixed-cell therapies expanded
from a patient's own bone marrow and delivered directly to damaged
tissues. Aastrom has advanced its cell therapies into late-stage
clinical development, including a planned Phase 3 clinical program
for the treatment of patients with critical limb ischemia and two
ongoing Phase 2 clinical trials in patients with dilated
cardiomyopathy. For more information, please visit Aastrom's
website at www.aastrom.com.
The Aastrom Biosciences, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3663
This document contains forward-looking statements, including
without limitation, statements concerning clinical trial plans and
progress, objectives and expectations, clinical activity timing,
intended product development, the performance and contribution of
certain individuals and expected timing of collecting and analyzing
treatment data, all of which involve certain risks and
uncertainties. These statements are often, but are not always, made
through the use of words or phrases such as "anticipates,"
"intends," "estimates," "plans," "expects," "we believe," "we
intend," and similar words or phrases, or future or conditional
verbs such as "will," "would," "should," "potential," "could,"
"may," or similar expressions. Actual results may differ
significantly from the expectations contained in the
forward-looking statements. Among the factors that may result in
differences are the inherent uncertainties associated with clinical
trial and product development activities, regulatory approval
requirements, competitive developments, and the availability of
resources and the allocation of resources among different potential
uses. These and other significant factors are discussed in greater
detail in Aastrom's Annual Report on Form 10-K, Quarterly Reports
on Form 10-Q and other filings with the Securities and Exchange
Commission. These forward looking statements reflect management's
current views and Aastrom does not undertake to update any of these
forward-looking statements to reflect a change in its views or
events or circumstances that occur after the date of this release
except as required by law.
AASTROM BIOSCIENCES,
INC. |
(in thousands, except
per share amounts) |
|
CONSOLIDATED CONDENSED
BALANCE SHEETS (Unaudited) |
|
|
December
31, |
|
2009 |
2010 |
ASSETS |
|
|
Cash and cash equivalents |
$ 14,739 |
$ 31,248 |
Other current assets |
645 |
451 |
Property and equipment, net |
1,240 |
1,128 |
Total assets |
$ 16,624 |
$ 32,827 |
|
|
|
LIABILITIES AND SHAREHOLDERS'
EQUITY |
|
|
Warrant liabilities |
$ 268 |
$ 25,718 |
Other current liabilities |
2,072 |
3,910 |
Long-term debt |
194 |
41 |
Shareholders' equity |
14,090 |
3,158 |
Total liabilities and shareholders'
equity |
$ 16,624 |
$ 32,827 |
|
CONSOLIDATED CONDENSED
STATEMENT OF OPERATIONS (Unaudited) |
|
|
Quarter
ended December 31, |
Six months
ended December 31, |
|
2009 |
2010 |
2009 |
2010 |
|
|
|
|
|
REVENUES |
$ 16 |
$ 253 |
$ 89 |
$ 253 |
|
|
|
|
|
COSTS AND EXPENSES |
|
|
|
|
Cost of product sales and
rentals |
2 |
2 |
34 |
2 |
Research and development |
3,283 |
4,442 |
6,194 |
8,609 |
Selling, general and
administrative |
1,316 |
1,579 |
2,262 |
3,265 |
Total costs and expenses |
4,601 |
6,023 |
8,490 |
11,876 |
|
|
|
|
|
LOSS FROM OPERATIONS |
(4,585) |
(5,770) |
(8,401) |
(11,623) |
|
|
|
|
|
OTHER INCOME (EXPENSE) |
|
|
|
|
(Increase) decrease in fair value
of Warrants |
255 |
(7,591) |
264 |
(7,690) |
Other income, net |
10 |
15 |
25 |
35 |
Total other income (expense) |
265 |
(7,576) |
289 |
(7,655) |
|
|
|
|
|
NET LOSS |
$ (4,320) |
$ (13,346) |
$ (8,112) |
$ (19,278) |
|
|
|
|
|
NET LOSS PER SHARE
(Basic and Diluted) |
$ (0.20) |
$ (0.44) |
$ (0.38) |
$ (0.66) |
|
|
|
|
|
Weighted average number of common
shares outstanding (Basic and Diluted) |
21,713 |
30,117 |
21,196 |
29,185 |
CONTACT: Investor contact
Bill Berry
Berry & Company
212 253-8881
ir@aastrom.com
bberry@berrypr.com
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