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, 2013. Aastrom will
host a conference call at 4:30 p.m. Eastern time today. Joining
Aastrom's senior management team on the call will be Dr. Nabil Dib,
MD, director of cardiovascular research at Mercy Gilbert and
Chandler Medical Centers in Phoenix, associate professor of
medicine and director of clinical cardiovascular cell therapy at
the University of California, San Diego, and founder and
editor-in-chief of the Journal of Cardiovascular Translational
Research. Dr. Dib is a world-renowned interventional cardiologist
and a principal investigator in the ixCELL-DCM study.
Aastrom reported a net loss attributable to common shareholders
of $6.8 million, or $0.15 per share, for the first quarter ended
March 31, 2013, compared to a net loss attributable to common
shareholders of $9.7 million, or $0.25 per share, for the first
quarter of 2012. The decrease in net loss is primarily due to
non-cash changes in the fair value of the company's outstanding
warrants and lower research and development expenses, offset
partially by the non-cash accretion of the company's convertible
preferred stock.
Research and development expenses for the quarter ended March
31, 2013 were $5.5 million, versus $6.8 million for the same period
in 2012. The decrease in research and development expenses
was primarily attributable to the reversal of nearly $0.9 million
of non-cash stock-based compensation expense related to a change in
estimated forfeitures as a result of the corporate
restructuring announced in March 2013. The remainder of the
decrease is primarily attributable to lower purchasing of
manufacturing supplies to align inventory levels with expected
clinical production volume.
General and administrative expenses for the quarter ended March
31, 2013 were down slightly at $1.6 million compared to $1.8
million for the same period in 2012. The decrease is primarily
attributable to the reversal of non-cash stock based compensation
expense related to a change in estimated forfeitures as a result of
the corporate restructuring.
Other income (expense) for the quarter ended March 31, 2013 was
$1.6 million, compared to $(0.9) 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 price of the company's common stock during each period and a
reduction in the number of warrants outstanding.
As of March 31, 2013, the company had a total of $9.2 million in
cash and cash equivalents, compared to $13.6 million in cash and
cash equivalents at December 31, 2012. The cash used for
operations of $6.8 million during the quarter was partially offset
by nearly $2.4 million of net proceeds from our At-the-Market
facility during the quarter.
Recent Business Highlights
During and since the first quarter of 2013, the company has:
- completed a strategic review and corporate restructuring to
focus on the development of ixmyelocel-T for the treatment of
advanced heart failure due to ischemic dilated cardiomyopathy
(DCM); Aastrom is no longer enrolling patients in the Phase 3
REVIVE-CLI clinical trial;
- initiated enrollment and treatment of patients in the Phase 2b
ixCELL-DCM clinical study of ixmyelocel-T in ischemic DCM heart
failure patients;
- filed a registration statement with the Securities and Exchange
Commission to sell up to $25 million in common stock to support the
continuation of the DCM clinical program and explore other
potential indications for ixmyelocel-T;
- further demonstrated the clinical and commercial potential of
ixmyelocel-T in poster presentations at the 19th Annual
International Society for Cellular Therapy Meeting and the
Arteriosclerosis, Thrombosis and Vascular Biology 2013 Scientific
Sessions, including presentation of new information about the
production and commercialization of ixmyelocel-T and its potential
use to treat a variety of inflammatory and vascular diseases;
and
- received shareholder approval of all pending proxy matters at
the company's annual meeting, including the election of directors
and advisory vote on executive compensation.
"I believe we have taken the right steps to address our capital
requirements, secure our financial position and advance our most
promising clinical program," said Nick Colangelo, president and
chief executive officer of Aastrom. "Focusing on the
development of ixmyelocel-T to treat advanced heart failure due to
ischemic DCM allows us to target an area of significant unmet
medical need and a highly compelling commercial opportunity for the
company. Importantly, the orphan drug designation for
ixmyelocel-T in this indication provides a potentially streamlined
path to commercialization for the product."
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 65210068. The call
will also 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 12, 2013 by calling
(855) 859-2056, or from outside the U.S. at (404) 537-3406 and
using conference ID 65210068. The webcast will also be
available after the live event at
http://investors.aastrom.com/events.cfm until May 8, 2014.
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 2b clinical trial in patients with ischemic 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) |
|
|
|
CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) |
|
|
|
|
December 31,
2012 |
March 31, 2013 |
ASSETS |
|
|
Cash and cash
equivalents |
$ 13,638 |
$ 9,226 |
Other current assets |
352 |
300 |
Property and equipment,
net |
1,188 |
1,056 |
Total assets |
$ 15,178 |
$ 10,582 |
|
|
|
LIABILITIES, CONVERTIBLE PREFERRED
STOCK AND SHAREHOLDERS' DEFICIT |
|
|
Warrant liabilities |
$ 1,995 |
$ 376 |
Other current
liabilities |
3,664 |
3,900 |
Long-term debt |
6 |
2 |
Series B-1 non-voting
convertible preferred stock |
3,923 |
5,186 |
Series B-2 voting convertible
preferred stock |
37,690 |
37,690 |
Shareholders' deficit |
(32,100) |
(36,572) |
Total liabilities, convertible
preferred stock and shareholders' deficit |
$ 15,178 |
$ 10,582 |
|
|
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) |
|
|
|
|
Quarter Ended
March 31, |
|
2012 |
2013 |
|
|
|
REVENUES |
$ 2 |
$ 8 |
|
|
|
COSTS AND EXPENSES |
|
|
Cost of product sales and
rentals |
2 |
2 |
Research and development |
6,796 |
5,538 |
Selling, general and
administrative |
1,762 |
1,633 |
Total costs and
expenses |
8,560 |
7,173 |
|
|
|
LOSS FROM OPERATIONS |
(8,558) |
(7,165) |
|
|
|
OTHER INCOME (EXPENSE) |
|
|
(Increase) decrease in fair
value of warrants |
(900) |
1,619 |
Other income, net |
3 |
2 |
Total other income
(expense) |
(897) |
1,621 |
|
|
|
NET LOSS |
(9,455) |
(5,544) |
|
|
|
ACCRETION OF CONVERTIBLE PREFERRED
STOCK |
289 |
1,263 |
|
|
|
NET LOSS ATTRIBUTABLE TO COMMON
SHAREHOLDERS |
(9,744) |
(6,807) |
|
|
|
NET LOSS PER SHARE ATTRIBUTABLE TO
COMMON SHAREHOLDERS (Basic and Diluted) |
$ (0.25) |
$ (0.15) |
|
|
|
Weighted average number of common shares
outstanding (Basic and Diluted) |
38,742 |
44,864 |
CONTACT: Media contact
Andrea Coan
Berry & Company
acoan@berrypr.com
(212) 253-8881
Investor contact
Chad Rubin
The Trout Group
crubin@troutgroup.com
(646) 378-2947
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