Aastrom Biosciences Reports First Quarter 2012 Financial Results
11 May 2012 - 6:01AM
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 first quarter ended March 31, 2012.
Aastrom reported a net loss attributable to common shareholders
of $9.7 million, or $0.25 per share, for the first quarter ended
March 31, 2012, compared to a net loss attributable to common
shareholders of $5.0 million, or $0.13 per share, for the first
quarter of 2011. The increase in net loss compared to the first
quarter of 2011 is primarily due to non-cash changes in the fair
value of the company's outstanding warrants and an increase in
research and development expenses.
Research and development expenses for the quarter ended March
31, 2012 were $6.8 million, versus $4.4 million for the same period
in 2011. The increase in research and development expenses 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 ended March
31, 2012 were down slightly at $1.8 million compared to $1.9
million for the same period in 2011.
Other income (expense) for the quarter ended March 31, 2012 was
$(0.9) million, compared to $1.3 million for the same period a year
ago. The fluctuation is 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 during each
period.
As of March 31, 2012, the company had a total of $36.7 million
in cash and cash equivalents, compared to $5.5 million in cash and
cash equivalents at December 31, 2011. The increase reflects the
net proceeds of $37.7 million from the March 9, 2012
private-placement financing with Eastern Capital Limited, offset
partially by $6.6 million of cash used for operations in the first
quarter of 2012.
Recent Business Highlights
During and since the first quarter of 2012, the company has:
- Completed the largest financing in Aastrom's history through a
$40 million private placement with Eastern Capital Limited. The
investment was made on very good terms with a five-year commitment,
no warrants and was priced at a premium;
- Initiated patient enrollment in the Phase 3 REVIVE-CLI clinical
study of ixmyelocel-T in patients with critical limb ischemia;
- Published positive 12-month results from the Phase 2b
RESTORE-CLI clinical study in a peer-reviewed article in the
journal Molecular Therapy;
- Presented new findings on the potential cardiovascular benefits
of ixmyelocel-T at the Keystone Symposia on
Atherosclerosis. These findings suggest certain cells
contained in ixmyelocel-T may help treat atherosclerosis;
- Appointed Dr. LaVonne Lang as head of regulatory affairs;
and
- Obtained shareholder approval on several important proxy
proposals at the company's annual meeting, including re-election of
directors, amendment of the company's equity incentive plan and
authorization to issue shares in conjunction with the recent
investment by Eastern Capital Limited.
Tim Mayleben, president and chief executive officer of Aastrom,
stated: "We are continuing to advance ixmyelocel-T as a
potential treatment for critical limb ischemia and dilated
cardiomyopathy, as evidenced by the launch of the Phase 3
REVIVE-CLI study, our preparation for a new Phase 2b trial in DCM
and recent presentation and publication of our clinical findings in
a variety of important peer-reviewed venues. As a result of
these activities and our recent successful financing, we are now in
a much stronger position to expedite these important clinical
programs and move ixmyelocel-T closer to commercialization."
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 67798610. 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 May 14, 2012 by calling
(855) 859-2056, or from outside the U.S. at (404) 537-3406 and
using conference ID 67798610. The webcast will also be
available after the live event at
http://investors.aastrom.com/events.cfm until May 10, 2013.
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, |
March 31, |
|
2011 |
2012 |
ASSETS |
|
|
Cash and cash equivalents |
$ 5,530 |
$ 36,733 |
Other current assets |
645 |
464 |
Property and equipment, net |
1,564 |
1,467 |
Total assets |
$ 7,739 |
$ 38,664 |
|
|
|
LIABILITIES, CONVERTIBLE PREFERRED
STOCK AND SHAREHOLDERS' DEFICIT |
|
|
Warrant liabilities |
$ 16,625 |
$ 17,525 |
Other current liabilities |
4,045 |
4,822 |
Long-term debt |
40 |
29 |
Series B convertible preferred stock |
-- |
38,012 |
Shareholders' deficit |
(12,971) |
(21,724) |
Total liabilities, convertible preferred
stock and shareholders' deficit |
$ 7,739 |
$ 38,664 |
|
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) |
|
|
Quarter
Ended March 31, |
|
2011 |
2012 |
|
|
|
REVENUES . |
$ 9 |
$ 2 |
|
|
|
COSTS AND EXPENSES |
|
|
Cost of product sales and rentals . |
2 |
2 |
Research and development . |
4,372 |
6,796 |
Selling, general and administrative .
|
1,895 |
1,762 |
Total costs and expenses |
6,269 |
8,560 |
|
|
|
LOSS FROM OPERATIONS |
(6,260) |
(8,558) |
|
|
|
OTHER INCOME (EXPENSE) |
|
|
(Increase) decrease in fair value of
warrants |
1,254 |
(900) |
Other income, net . |
18 |
3 |
Total other income (expense) . |
1,272 |
(897) |
|
|
|
NET LOSS |
(4,988) |
(9,455) |
ACCRETION OF CONVERTIBLE PREFERRED
STOCK |
-- |
289 |
NET LOSS ATTRIBUTABLE TO COMMON
SHAREHOLDERS |
$ (4,988) |
$ (9,744) |
|
|
|
NET LOSS PER SHARE ATTRIBUTABLE TO
COMMON SHAREHOLDERS (Basic and Diluted) |
$ (0.13) |
$ (0.25) |
|
|
|
Weighted average number of common shares
outstanding (Basic and Diluted) |
38,617 |
38,742 |
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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