Aastrom Biosciences Reports Operating Results for the Quarter and Six Months Ended June 30, 2011
August 15 2011 - 4:01PM
- Phase 3 REVIVE-CLI clinical trial to begin next quarter
- Final Phase 2b CLI data presentation at AHA meeting in
November
- Final Phase 2 DCM data presentation at HFSA meeting next
month
- Quarterly corporate conference call today at 4:30 PM ET
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific, multicellular therapies for the treatment of
severe chronic cardiovascular diseases, today reported operating
results for the quarter and six months ended June 30, 2011.
"During the second quarter we reached two important milestones:
the completion of the Phase 2b RESTORE-CLI clinical trial, which
established clinical proof-of-concept in no-option CLI patients,
and completion of the Special Protocol Assessment (SPA) process
with the FDA for our Phase 3 clinical trial for ixmyelocel-T in
patients with critical limb ischemia who have no other treatment
options. We are planning to launch this pivotal Phase 3 clinical
trial and advance it through the final stages of clinical
development and regulatory review with the support of our
outstanding clinical team and advisors," said Tim Mayleben,
president and CEO of Aastrom. "We look forward to presenting
final 12-month results from the Phase 2b RESTORE-CLI study at the
American Heart Association meeting on November 14th and the final
12-month results from the Phase 2 dilated cardiomyopathy surgical
study at the Heart Failure Society of America meeting on September
19th."
As of June 30, 2011, the company had $18.5 million in cash and
cash equivalents, compared to $31.2 million in cash and cash
equivalents at December 31, 2010. For the quarter and six
months ended June 30, 2011, cash expenses were $6.1 million and
$12.7 million, respectively.
Research and development expenses for the quarter and six months
ended June 30, 2011, were $5.3 million and $9.7 million,
respectively, versus $3.6 million and $6.5 million for the same
periods a year ago. The increase in research and development
expenses for both periods was primarily attributable to the
preparation for the Phase 3 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 six
months ended June 30, 2011, were $2.2 million and $4.1 million,
respectively, compared to $1.5 million and $2.9 million for the
same periods a year ago. The increase in general and
administrative expenses for both periods was primarily due to an
increase in regulatory, legal and employee-related expenses,
including non-cash stock-based compensation expense. The
increase in the six months ended June 30, 2011, compared to a year
ago was also driven by the previously announced restatement of the
company's historical financial results in the first quarter of
2011.
Other income (expense) for the quarter and six months ended June
30, 2011, was $(2.5) million and $(1.2) million, respectively,
compared to $1.4 million and $2.9 million for the same periods a
year ago. These fluctuations were due to non-cash changes in
the fair value of the company's outstanding warrants, driven by an
increase in the fair market value of the company's common stock
during these periods.
Net loss for the quarter and six months ended June 30, 2011, was
$10.0 million, or $0.26 per share, and $15.0 million, or $0.39 per
share, respectively, compared to a net loss of $3.8 million, or
$0.13 per share, and $6.5 million, or $0.23 per share, for the same
periods a year ago.
As of June 30, 2011, Aastrom had 38.6 million shares of common
stock outstanding.
About Aastrom Biosciences
Aastrom Biosciences is the leader in developing
patient-specific, expanded multicellular therapies for use in the
treatment of 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.
AASTROM
BIOSCIENCES |
|
(in thousands, except
per share amounts) |
|
|
|
CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) |
|
|
|
|
December
31, |
June 30, |
|
|
2010 |
|
2011 |
|
ASSETS |
|
|
|
|
Cash and cash
equivalents |
$ 31,248 |
|
$ 18,521 |
|
Other current assets |
451 |
|
524 |
|
Property and equipment,
net |
1,128 |
|
1,259 |
|
Total assets |
$ 32,827 |
|
$ 20,304 |
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
(DEFICIT) |
|
|
|
|
Warrant liabilities |
$ 25,954 |
|
$ 27,164 |
|
Other current
liabilities |
3,910 |
|
3,255 |
|
Long-term debt |
41 |
|
43 |
|
Shareholders' equity
(deficit) |
2,922 |
|
(10,158) |
Total liabilities and
shareholders' equity (deficit) |
$ 32,827 |
|
$ 20,304 |
|
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited)
|
|
|
Quarter
Ended June 30, |
Six Months
Ended June 30, |
|
2010
|
2011 |
2010 |
2011 |
|
|
|
|
|
REVENUES . |
$ -- |
$ -- |
$ -- |
$ 9 |
|
|
|
|
|
COSTS AND EXPENSES |
|
|
|
|
Cost of product sales and
rentals |
-- |
-- |
-- |
2 |
Research and
development |
3,619 |
5,304 |
6,464 |
9,676 |
Selling, general and
administrative |
1,521 |
2,203 |
2,939 |
4,098 |
Total costs and
expenses |
5,140 |
7,507 |
9,403 |
13,776 |
|
|
|
|
|
LOSS FROM OPERATIONS |
(5,140) |
(7,507) |
(9,403) |
(13,767) |
|
|
|
|
|
OTHER INCOME (EXPENSE) |
|
|
|
|
(Increase) decrease in
fair value of warrants |
1,348 |
(2,465) |
2,907 |
(1,210) |
Other income, net |
25 |
15 |
50 |
32 |
Total other income
(expense) |
1,373 |
(2,450) |
2,957 |
(1,178) |
|
|
|
|
|
NET LOSS |
$ (3,767) |
$ (9,957) |
$ (6,446) |
$ (14,945) |
|
|
|
|
|
NET LOSS PER SHARE
(Basic and Diluted) |
$ (0.13) |
$ (0.26) |
$ (0.23) |
$ (0.3) |
|
|
|
|
|
|
Weighted average number of common
shares outstanding (Basic and Diluted) |
28,256 |
38,622 |
27,500 |
38,619 |
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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