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, 2013.
Aastrom reported a net loss for the quarter and year ended
December 31, 2013 of $2.9 million, or $0.65 per share, and $15.6
million, or $6.95 per share, respectively, compared to $6.7
million, or $3.60 per share, and $29.5 million, or $16.25 per
share, for the same periods a year ago. The substantial decrease in
net loss from the prior year is primarily due to decreases in
research and development and general and administrative expenses
and the non-cash change in the fair value of warrants.
Research and development expenses for the quarter and year ended
December 31, 2013 were $3.3 million and $15.1 million,
respectively, versus $6.0 million and $26.0 million for the same
periods a year ago. The decrease in expenses is due to a reduction
in clinical trial expenses, the execution of a corporate
restructuring that substantially reduced headcount and operating
expenses, and the reversal of non-cash stock compensation expenses
due to the forfeiture of stock options.
General and administrative expenses for the quarter and year
ended December 31, 2013 were $1.6 million and $5.9 million,
respectively, compared to $1.6 million and $7.8 million for the
same periods a year ago. The decrease in expenses for the year is
due to the reduction of operating expenses resulting from the
corporate restructuring and the reversal of non-cash stock
compensation expenses related to the forfeiture of stock
options.
Other income for the quarter and year ended December 31, 2013
was $2.0 million and $5.3 million, respectively, compared to $1.0
million and $4.3 million for the same periods a year ago. The
increase in other income is due primarily to the non-cash change in
the fair value of warrants due to the decline in Aastrom's stock
price, the reduction in the number of December 2010 and August 2013
warrants outstanding and the reduction in the time to maturity for
the warrants.
As of December 31, 2013, the company had $8.1 million in cash
and cash equivalents, compared to $13.6 million in cash and cash
equivalents as of December 31, 2012, and approximately $10.8
million in cash and cash equivalents as of February 28, 2014. For
the quarter and year ended December 31, 2013, cash used for
operations was $4.3 million and $19.9 million, respectively.
Recent Business Highlights
During and since the fourth quarter of 2013, the company
has:
- regained compliance with NASDAQ listing requirements;
- entered into a $15 million equity commitment with Lincoln Park
Capital;
- received a key composition-of-matter patent from the Australian
Patent Office that provides protection for our lead product,
ixmyelocel-T, through 2027;
- published results from two separate preclinical research
studies of ixmyelocel-T in the peer-reviewed journal Stem Cell
Research & Therapy;
- continued site activation and enrollment of patients in the
Phase 2b ixCELL-DCM clinical study of ixmyelocel-T for the
treatment of advanced heart failure due to ischemic dilated
cardiomyopathy (DCM);
- continued progress towards planned completion of the REVIVE-CLI
clinical study of ixmyelocel-T for the treatment of critical limb
ischemia; and
- continued to support clinical evaluation of ixmyelocel-T at the
University of Michigan for patients with craniofacial defects
undergoing reconstructive surgery.
"With the completion of a number of operational and financial
initiatives in 2013, we are well-positioned to continue to build on
our momentum in advancing our ongoing ixmyelocel-T clinical
programs, exploring new indications for ixmyelocel-T and pursuing
promising new business opportunities in 2014," said Nick Colangelo,
president and chief executive officer of Aastrom. "We are poised to
achieve a number of important milestones this year that have the
potential to create significant value for shareholders going
forward."
Conference Call Information
Aastrom's management will host a conference call to discuss
these results on Thursday, March 13, 2014 at 4:30 p.m. Eastern
time. Interested parties should call toll-free (877) 312-5881, or
from outside the U.S. (253) 237-1173 and use conference ID 5780779.
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 17, 2014 by
calling (855) 859-2056, or from outside the U.S. at (404) 537-3406
and using conference ID 5780779. The webcast will also be
available after the live event at
http://investors.aastrom.com/events.cfm until March 17,
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 future purchases pursuant
to the purchase agreement with Lincoln Park, clinical trial plans
and progress, objectives and expectations, clinical activity
timing, intended product development, 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 the
closing of the offering described herein, Aastrom's intended use of
proceeds in connection with the offering, 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, |
|
|
|
2012 |
2013 |
ASSETS |
|
|
Cash |
$ 13,638 |
$ 8,059 |
Other current
assets |
352 |
417 |
Property and
equipment, net |
1,188 |
739 |
Total assets |
$ 15,178 |
$ 9,215 |
|
|
|
|
|
LIABILITIES CONVERTIBLE
PREFERRED STOCK AND SHAREHOLDERS' EQUITY (DEFICIT) |
|
|
Warrant
liabilities |
$ 1,995 |
$ 2,019 |
Other current
liabilities |
3,664 |
3,302 |
Long-term debt |
6 |
-- |
Series B-1
non-voting convertible preferred stock |
3,923 |
-- |
Series B-2 voting
convertible preferred stock |
37,690 |
-- |
Shareholders'
equity (deficit) |
(32,100) |
3,894 |
Total liabilities,
convertible preferred stock and shareholders' equity (deficit) |
$ 15,178 |
$ 9,215 |
|
|
|
|
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) |
|
|
|
|
|
|
Quarter
Ended |
Year
Ended |
|
December
31, |
December
31, |
|
2012 |
2013 |
2012 |
2013 |
|
|
|
|
|
REVENUES |
$ 19 |
$ 8 |
$ 21 |
$ 19 |
|
|
|
|
|
COSTS AND EXPENSES |
|
|
|
|
Cost of product sales and
rentals |
4 |
1 |
6 |
4 |
Research and development |
6,013 |
3,315 |
26,025 |
15,104 |
Selling, general and
administrative |
1,619 |
1,616 |
7,750 |
5,875 |
Total costs and expenses |
7,636 |
4,932 |
33,781 |
20,983 |
|
|
|
|
|
LOSS FROM OPERATIONS |
(7,617) |
(4,924) |
(33,760) |
(20,964) |
|
|
|
|
|
OTHER INCOME |
|
|
|
|
Decrease in fair value of
warrants |
959 |
2,006 |
4,248 |
5,337 |
Other income, net |
8 |
2 |
38 |
5 |
Total other income |
967 |
2,008 |
4,286 |
5,342 |
|
|
|
|
|
NET LOSS |
$ (6,650) |
$ (2,916) |
$ (29,474) |
$ (15,622) |
|
|
|
|
|
NET LOSS PER SHARE ATTRIBUTABLE TO
COMMON SHAREHOLDERS (Basic and Diluted) |
$ (3.60) |
$ (0.97) |
$ (16.25) |
$ (6.95) |
|
|
|
|
|
Weighted average number of common shares
outstanding (Basic and Diluted) |
2,189 |
4,469 |
2,060 |
3,016 |
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
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Aug 2024 to Sep 2024
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Sep 2023 to Sep 2024