Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific expanded multicellular therapies for the treatment
of severe chronic cardiovascular diseases, today reported financial
results for the quarter and nine months ended September 30, 2011.
"Our recent financial results reflect the rapid advancement of
our clinical programs this year, including plans to initiate the
REVIVE-CLI Phase 3 clinical trial of ixmyelocel-T in the fourth
quarter of 2011. This trial will enroll patients with critical limb
ischemia who have no other treatment options available," said Tim
Mayleben, president and CEO of Aastrom. "We also look forward to
presenting the final results from the Phase 2b RESTORE-CLI clinical
study on November 14, 2011 at the American Heart Association
Scientific Sessions in Orlando, Florida."
Aastrom reported a net loss of $1.9 million, or $0.05 per share,
for the third quarter of 2011 compared to a net loss of $5.9
million, or $0.21 per share, for the same period a year ago. For
the nine months ended September 30, 2011, Aastrom reported a net
loss of $16.9 million, or $0.44 per share, compared to $12.4
million, or $0.45 per share for the same period in 2010.
Research and development expenses for the quarter and nine
months ended September 30, 2011 were $5.8 million and $15.4
million, respectively, versus $4.2 million and $10.6 million for
the same periods a year ago. The increase in research and
development expenses for both periods was primarily attributable to
advanced preparations for the Phase 3 REVIVE-CLI clinical program
for ixmyelocel-T as well as an increase in non-cash stock-based
compensation expense.
General and administrative expenses for the quarter and nine
months ended September 30, 2011 were $1.7 million and $5.8 million,
respectively, compared to $1.7 million and $4.6 million for the
same periods a year ago. The increase in general and administrative
expenses for the nine months ended September 30, 2011 was primarily
due to an increase in consulting and employee-related expenses,
including non-cash stock-based compensation expenses, as well as
costs related to the previously announced restatement of the
company's historical financial results in the first quarter of
2011.
Other income (expense) for the quarter and nine months ended
September 30, 2011 was $5.5 million and $4.3 million, respectively,
compared to $(0.1) million and $2.8 million for the same periods a
year ago. The fluctuations are due to non-cash changes in the fair
value of the company's outstanding warrants, driven by the change
in the fair market value of the company's common stock in these
periods.
As of September 30, 2011, the company had $11.9 million in cash
and cash equivalents, compared to $31.2 million in cash and cash
equivalents at December 31, 2010, and 38.6 million shares of common
stock outstanding.
Recent Business Highlights
During and since the third quarter of 2011, we have:
- Reached agreement with the U.S. Food and Drug Administration
regarding the special protocol assessment for the proposed Phase 3
REVIVE-CLI clinical program for ixmyelocel-T in patients with
critical limb ischemia who have no other treatment options,
positioning us to launch the Phase 3 trial this quarter.
- Presented 12-month results from the Phase 1/2 IMPACT-DCM
dilated cardiomyopathy surgical study at the Heart Failure Society
of America meeting. The study showed that treatment with
ixmyelocel-T was well-tolerated and consistent with improved
myocardium function in patients with DCM, especially those with
ischemic cardiomyopathy.
- Reported top-line six-month interim results from the DCM
catheter study showing evidence of fewer adverse events and
comparable efficacy results compared to the 12-month results from
the IMPACT-DCM surgical study. Aastrom plans to initiate a Phase 2b
study of ixmyelocel-T in the treatment of DCM in the first half of
2012.
- Received a key composition-of-matter patent from the European
Patent Office providing protection throughout the European Union
for various claims regarding the composition and production of
mixed cell populations which characterize ixmyelocel-T.
Conference Call Information
Aastrom's management will host a conference call to discuss
these results at 4:30 p.m. (ET) today. Interested parties should
call toll-free (877) 312-5881, or from outside the U.S. (253)
237-1173 and use conference ID 17046596. The call will be available
live in the Investors section of Aastrom's website at
http://investors.aastrom.com/investors.cfm. A replay of the call
will be available until November 12, 2011 by calling (855)
859-2056, or from outside the U.S. at (404) 537-3406 and using
conference ID 17046596. A podcast will also be available after the
live event at http://investors.aastrom.com/events.cfm.
About Aastrom Biosciences
Aastrom Biosciences is the leader in developing
patient-specific, expanded multicellular therapies for use in the
treatment of patients with severe, chronic cardiovascular diseases.
The company's proprietary cell-processing technology enables the
manufacture of ixmyelocel-T, a patient-specific multicellular
therapy expanded from a patient's own bone marrow and delivered
directly to damaged tissues. Aastrom has advanced ixmyelocel-T into
late-stage clinical development, including a planned Phase 3
clinical program to study patients with critical limb ischemia and
two 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 or Transition Report on Form 10-K or
10-K/T, 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.
- Financial results follow -
AASTROM BIOSCIENCES,
INC. (in thousands, except per share
amounts) CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
December 31,
2010 |
|
|
September 30,
2011 |
|
|
ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
$ 31,248 |
|
|
$ 11,947 |
|
|
Other current assets |
451 |
|
|
631 |
|
|
Property and equipment,
net |
1,128 |
|
|
1,494 |
|
|
Total assets |
$ 32,827 |
|
|
$ 14,072 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
(DEFICIT) |
|
|
|
|
|
|
Warrant liabilities |
$ 25,954 |
|
|
$ 21,668 |
|
|
Other current liabilities |
3,910 |
|
|
3,513 |
|
|
Long-term debt |
41 |
|
|
49 |
|
|
Shareholders' equity
(deficit) |
2,922 |
|
|
(11,158) |
|
Total liabilities and
shareholders' equity (deficit) |
$ 32,827 |
|
|
$ 14,072 |
|
|
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) |
|
|
|
|
|
|
Quarter Ended
September 30, |
Nine Months Ended
September 30, |
|
2010
|
2011 |
2010 |
2011 |
|
|
|
|
|
REVENUES |
$ -- |
$ 9 |
$ -- |
$ 18 |
|
|
|
|
|
COSTS AND EXPENSES |
|
|
|
|
Cost of product sales and
rentals |
-- |
2 |
-- |
4 |
Research and development |
4,167 |
5,750 |
10,631 |
15,426 |
Selling, general and
administrative |
1,686 |
1,696 |
4,625 |
5,794 |
Total costs and
expenses |
5,853 |
7,448 |
15,256 |
21,224 |
|
|
|
|
|
LOSS FROM OPERATIONS |
(5,853) |
(7,439) |
(15,256) |
(21,206) |
|
|
|
|
|
OTHER INCOME (EXPENSE) |
|
|
|
|
(Increase) decrease in fair
value of warrants |
(99) |
5,496 |
2,808 |
4,286 |
Other income, net |
20 |
9 |
70 |
41 |
Total other income
(expense) |
(79) |
5,505 |
2,878 |
4,327 |
|
|
|
|
|
NET LOSS |
$ (5,932) |
$ (1,934) |
$ (12,378) |
$ (16,879) |
|
|
|
|
|
NET LOSS PER
SHARE |
|
|
|
|
(Basic and
Diluted) |
$ (0.21) |
$ (0.05) |
$ (0.45) |
$ (0.44) |
|
|
|
|
|
Weighted average number of common shares
outstanding (Basic and Diluted) |
28,255 |
38,632 |
27,755 |
38,624 |
CONTACT: Media contact
Bill Berry
Berry & Company
bberry@berrypr.com
(212) 253-8881
Investor contact
Danielle Spangler
The Trout Group
dspangler@troutgroup.com
(646) 378-2924
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