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 fourth quarter and year ended December 31, 2011.
Aastrom reported a net loss of $2.8 million, or $0.07 per share,
for the fourth quarter and $19.7 million, or $0.51 per share, for
the year ended December 31, 2011 compared to a net loss of $13.2
million, or $0.44 per share, and $25.5 million, or $0.90 per share,
for the same periods in 2010.
Research and development expenses for the quarter and year ended
December 31, 2011 were $5.9 million and $21.3 million,
respectively, versus $4.4 million and $15.1 million for the same
periods in 2010. The increase in R&D expenses for both periods
was primarily attributable to an increase in headcount and
consulting costs as we prepared for the Phase 3 REVIVE clinical
program for ixmyelocel-T, as well as an increase in non-cash
stock-based compensation expenses.
General and administrative expenses for the quarter and year
ended December 31, 2011 were $1.9 million and $7.7 million,
respectively, compared to $1.6 million and $6.2 million for the
same periods in 2010. The increase in general and administrative
expenses was primarily due to an increase in non-cash stock-based
compensation expense.
Other income (expense) for the quarter and year ended December
31, 2011 was $5.0 million and $9.4 million, respectively, compared
to $(7.4) million and $(4.5) 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, primarily driven by the
change in the fair market value of the company's common stock in
these periods.
As of December 31, 2011, the company had a total of $5.5 million
in cash and cash equivalents, compared to $31.2 million in cash and
cash equivalents at December 31, 2010. In addition, the company
recently announced a $40 million private placement, with net
proceeds to Aastrom, after placement fees and other offering
expenses, of $37.8 million.
Recent Business Highlights
During and since the fourth quarter of 2011, the company
has:
- Completed the largest financing in Aastrom's history through a
$40 million private placement;
- Initiated patient enrollment in the Phase 3 REVIVE-CLI clinical
study of ixmyelocel-T in patients with critical limb ischemia;
- Reported and presented positive 12-month results from the Phase
2b RESTORE-CLI clinical study at the American Heart Association
Scientific Sessions; and
- Received a notice of issuance of a key composition-of-matter
patent from the European Patent Office for ixmyelocel-T.
Tim Mayleben, president and chief executive officer of Aastrom,
stated: "This has been a transformational period for
Aastrom. We have completed the Phase 2b RESTORE-CLI clinical
study, published and presented our work at peer-reviewed meetings,
including the American Heart Association Scientific Sessions,
created a Phase 3 steering committee for our pivotal CLI clinical
trial, obtained FDA approval of a Special Protocol Assessment and
fast-track status for our Phase 3 CLI program, launched the Phase 3
REVIVE-CLI study and completed a $40 million financing. As a
result of this productivity and success, we now have the momentum
and financial resources to advance our clinical programs in
critical limb ischemia and dilated cardiomyopathy and pursue
productive discussions with a number of potential partners this
year."
Conference Call Information
Aastrom's management will host a conference call to discuss
these results at 4:30 p.m. Eastern time today. Interested
parties should call toll-free (877) 312-5881, or from outside the
U.S. (253) 237-1173 and use conference ID 48237558. 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 March 16, 2012 by
calling (855) 859-2056, or from outside the U.S. at (404) 537-3406
and using conference ID 48237558. 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
Phase 3 clinical program to study patients with critical limb
ischemia and a planned Phase 2b clinical trial in patients with
ischemic dilated cardiomyopathy. For more information, please visit
Aastrom's website at www.aastrom.com. For more information on
the pivotal REVIVE Phase 3 clinical trial, please visit the trial
website at www.revivecli.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,
INC. |
(in thousands, except
per share amounts) |
|
CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) |
|
|
December
31, |
|
2010 |
2011 |
ASSETS |
|
|
Cash and cash equivalents |
$ 31,248 |
$ 5,530 |
Other current assets |
451 |
645 |
Property and equipment, net |
1,128 |
1,564 |
Total assets |
$ 32,827 |
$ 7,739 |
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
(DEFICIT) |
|
|
Warrant liabilities |
$ 25,954 |
$ 16,625 |
Other current liabilities |
3,910 |
4,045 |
Long-term debt |
41 |
40 |
Shareholders' equity (deficit) |
2,922 |
(12,971) |
Total liabilities and shareholders'
equity (deficit) |
$ 32,827 |
$ 7,739 |
|
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) |
|
|
Quarter
Ended December 31, |
Year
Ended December 31, |
|
2010
|
2011 |
2010 |
2011 |
|
|
|
|
|
REVENUES . |
$ 253 |
$ -- |
$ 253 |
$ 18 |
|
|
|
|
|
COSTS AND EXPENSES |
|
|
|
|
Cost of product sales and rentals
. |
2 |
-- |
2 |
4 |
Research and development . |
4,442 |
5,904 |
15,073 |
21,330 |
Selling, general and administrative
. |
1,579 |
1,930 |
6,204 |
7,724 |
Total costs and expenses |
6,023 |
7,834 |
21,279 |
29,058 |
|
|
|
|
|
LOSS FROM OPERATIONS |
(5,770) |
(7,834) |
(21,026) |
(29,040) |
|
|
|
|
|
OTHER INCOME (EXPENSE) |
|
|
|
|
(Increase) decrease in fair value
of warrants |
(7,401) |
5,042 |
(4,593) |
9,329 |
Other income, net . |
15 |
3 |
85 |
43 |
Total other income (expense) . |
(7,386) |
5,045 |
(4,508) |
9,372 |
|
|
|
|
|
NET LOSS |
$ (13,156) |
$ (2,789) |
$ (25,534) |
$ (19,668) |
|
|
|
|
|
NET LOSS PER SHARE (Basic and
Diluted) |
$ (0.44) |
$ (0.07) |
$ (0.90) |
$ (0.51) |
|
|
|
|
|
Weighted average number of common shares
outstanding (Basic and Diluted) |
30,117 |
38,635 |
28,350 |
38,627 |
CONTACT: Media contact
Andrea Coan
Berry & Company
acoan@berrypr.com
(212) 253-8881
Investor contact
Danielle Spangler
The Trout Group
dspangler@troutgroup.com
(646) 378-2924
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