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, 2012.
Aastrom reported a net loss attributable to common shareholders
of $7.9 million, or $0.18 per share, for the fourth quarter and
$33.5 million, or $0.81 per share, for the year ended December 31,
2012 compared to a net loss of $2.8 million, or $0.07 per share,
and $19.7 million, or $0.51 per share, for the same periods in
2011. The increase in net loss for both periods is primarily due to
the non-cash change in the fair value of warrants, the non-cash
accretion of our convertible preferred stock and increases in
research and development expenses.
Research and development expenses for the quarter and year ended
December 31, 2012 were $6.0 million and $26.0 million,
respectively, versus $5.9 million and $21.3 million for the same
periods in 2011. The increase in R&D expenses for both periods
was primarily attributable to the launch of the Phase 2b ixCELL-DCM
clinical study and the ongoing 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, 2012 were $1.6 million and $7.8 million,
respectively, compared to $1.9 million and $7.7 million for the
same periods in 2011. The fourth quarter of 2012 includes a
reversal of nearly $1 million in non-cash stock based compensation
expense related to stock option forfeitures. This was offset by an
increase in non-cash stock based compensation expense before the
forfeiture adjustment and slightly higher legal and consulting
costs.
Other income for the quarter and year ended December 31, 2012
was $1.0 million and $4.3 million, respectively, compared to $5.0
million and $9.4 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, 2012, the company had $13.6 million in cash
and cash equivalents, compared to $5.5 million in cash and cash
equivalents at December 31, 2011. For the quarter and year ended
December 31, 2012, cash used for operations was $7.3 million and
$29.5 million, respectively.
Recent Business Highlights
During and since the fourth quarter of 2012, the company
has:
- Appointed Nick Colangelo as president and chief executive
officer;
- Initiated patient enrollment in the Phase 2b ixCELL-DCM
clinical study of ixmyelocel-T in patients with ischemic dilated
cardiomyopathy;
- Increased the number of clinical investigators and sites
participating in the Phase 3 REVIVE clinical study of ixmyelocel-T
in patients with critical limb ischemia; and
- Appointed Joyce Frey-Vasconcells, Ph.D., to the company's
scientific advisory board.
Nick Colangelo, Aastrom's president and chief executive officer,
stated: "I am honored to have joined Aastrom at a time when we are
making important progress in advancing our ixmyelocel-T clinical
programs for patients with severe cardiovascular diseases who have
poor or no treatment options. In the year ahead, we will be focused
on completing enrollment in the Phase 2b ixCELL-DCM study,
accelerating the rate of enrollment in the Phase 3 REVIVE study,
addressing our capital requirements and managing our programs and
resources as efficiently as possible. I am excited about the
opportunities before us and look forward to reporting on our
progress throughout 2013."
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 92135677. 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 22, 2013 by calling (855) 859-2056,
or from outside the U.S. at (404) 537-3406 and using conference ID
92135677. 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 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 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, |
December 31, |
|
2011 |
2012 |
ASSETS |
|
|
Cash and cash equivalents |
$ 5,530 |
$ 13,638 |
Other current assets |
645 |
352 |
Property and equipment, net |
1,564 |
1,118 |
Total assets |
$ 7,739 |
$ 15,178 |
|
|
|
LIABILITIES, CONVERTIBLE PREFERRED
STOCK AND SHAREHOLDERS' DEFICIT |
|
|
Warrant liabilities |
$ 16,625 |
$ 1,995 |
Other current liabilities |
4,045 |
3,664 |
Long-term debt |
40 |
6 |
Series B-1 non-voting convertible
preferred stock |
-- |
3,923 |
Series B-2 voting convertible preferred
stock |
-- |
37,690 |
Shareholders' deficit |
(12,971) |
(32,100) |
Total liabilities,
convertible preferred stock and shareholders' deficit |
$ 7,739 |
$ 15,178 |
|
|
|
|
|
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) |
|
|
|
|
|
|
Quarter
Ended December 31, |
Year
Ended December 31, |
|
2011
|
2012 |
2011 |
2012 |
|
|
|
|
|
REVENUES |
$ -- |
$ 19 |
$ 18 |
$ 21 |
|
|
|
|
|
COSTS AND EXPENSES |
|
|
|
|
Cost of product sales and rentals |
-- |
4 |
4 |
6 |
Research and development |
5,904 |
6,013 |
21,330 |
26,025 |
Selling, general and administrative |
1,930 |
1,619 |
7,724 |
7,750 |
Total costs and
expenses |
7,834 |
7,636 |
29,058 |
33,781 |
|
|
|
|
|
LOSS FROM OPERATIONS |
(7,834) |
(7,617) |
(29,040) |
(33,760) |
|
|
|
|
|
OTHER INCOME (EXPENSE) |
|
|
|
|
Decrease in fair value of warrants
|
5,044 |
959 |
9,329 |
4,248 |
Other income, net |
1 |
8 |
43 |
38 |
Total other income |
5,045 |
967 |
9,372 |
4,286 |
|
|
|
|
|
NET LOSS |
(2,789) |
(6,650) |
(19,668) |
(29,474) |
|
|
|
|
|
ACCRETION OF CONVERTIBLE PREFERRED
STOCK |
-- |
1,255 |
-- |
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO COMMON
SHAREHOLDERS |
$ (2,789) |
$ (7,905) |
$ (19,668) |
$ (33,467) |
|
|
|
|
|
NET LOSS PER SHARE ATTRIBUTABLE TO
COMMON SHAREHOLDERS (Basic and Diluted) |
$ (0.07) |
$ (0.18) |
$ (0.51) |
$ (0.81) |
|
|
|
|
|
Weighted average number of common shares
outstanding (Basic and Diluted) |
38,635 |
43,784 |
38,627 |
41,199 |
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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