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 quarter and nine months ended
September 30, 2013.
Aastrom reported a net loss for the quarter and nine months
ended September 30, 2013 of $2.3 million, or $0.06 per share, and
$12.7 million, or $0.33 per share, respectively, compared to $6.0
million, or $0.17 per share, and $22.8 million, or $0.63 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 nine
months ended September 30, 2013 were $2.6 million and $11.8
million, respectively, versus $6.1 million and $20.0 million for
the same periods a year ago. The decrease is due to a reduction in
clinical trial expenses due to stopping enrollment in the REVIVE
clinical trial, 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 nine
months ended September 30, 2013 were $1.1 million and $4.3 million,
respectively, compared to $2.1 million and $6.1 million for the
same periods a year ago. The decrease 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 nine months ended September 30,
2013 was $1.4 million and $3.3 million, respectively, compared to
$2.3 million and $3.3 million for the same periods a year ago. The
change in value was primarily due to the decline in our stock
price, the adjustment to fair value due to the exercise of warrants
in September 2013, the reduction in the December 2010 warrants
outstanding and the reduction in the time to maturity for the
warrants.
As of September 30, 2013, the company had $10.8 million in cash
and cash equivalents, compared to $13.6 million in cash and cash
equivalents at December 31, 2012. For the quarter and nine months
ended September 30, 2013, cash used for operations was $4.1 million
and $15.6 million, respectively.
Recent Business Highlights
During and since the third quarter of 2013, the company has:
- completed a public offering of common stock and warrants that
raised approximately $9 million in gross proceeds before
commissions and offering expenses;
- amended the Series B preferred stock agreement with Eastern
Capital Limited, which substantially increased shareholders' equity
by approximately $42.9 million;
- completed a reverse split of Aastrom's common stock, enabling
the company to regain compliance with the NASDAQ minimum bid price
requirement;
- 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);
- received Health Canada approval of the company's clinical trial
application to initiate the ongoing Phase 2b ixCELL-DCM clinical
trial in Canada;
- continued to support clinical evaluation of ixmyelocel-T at the
University of Michigan for patients with craniofacial defects
undergoing reconstructive surgery;
- published results from two separate preclinical research
studies of ixmyelocel-T in the peer-reviewed journal Stem Cell
Research & Therapy; and,
- appointed Heidi Hagen, global chief operating officer at Sotio
LLC, to the Aastrom Board of Directors.
"With the completion of our corporate and financial
restructuring and our recent public offering and related financial
initiatives, we are well positioned to advance our ongoing clinical
and preclinical programs for ixmyelocel-T and to pursue promising
new clinical and business opportunities," said Nick Colangelo,
president and chief executive officer of Aastrom. "We are working
diligently to advance our development programs, expand our product
portfolio and clinical initiatives, and create significant value
for shareholders going forward."
Conference Call Information
Aastrom's management will host a conference call to discuss
these results on Tuesday, November 12, 2013 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
99005313. 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 November 16, 2013 by
calling (855) 859-2056, or from outside the U.S. at (404) 537-3406
and using conference ID 99005313. The webcast will also be
available after the live event at
http://investors.aastrom.com/events.cfm until November 12,
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 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 Registration Statement on Form S-1 described above,
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, |
September
30, |
|
2012 |
2013 |
ASSETS |
|
|
Cash and cash equivalents |
$13,638 |
$10,816 |
Other current assets |
352 |
545 |
Property and equipment,
net |
1,188 |
841 |
Total assets |
$15,178 |
$12,202 |
|
|
|
LIABILITIES CONVERTIBLE PREFERRED
STOCK AND SHAREHOLDERS' EQUITY (DEFICIT) |
Warrant liabilities |
$1,995 |
$4,025 |
Other current liabilities |
3,664 |
3,227 |
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) |
4,950 |
Total liabilities, convertible
preferred stock and shareholders' equity (deficit) |
$15,178 |
$12,202 |
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) |
|
|
|
|
|
|
Quarter
Ended |
Nine Months
Ended |
|
September
30, |
September
30, |
|
2012 |
2013 |
2012 |
2013 |
|
|
|
|
|
REVENUES . |
$ -- |
$ -- |
$2 |
$11 |
|
|
|
|
|
COSTS AND EXPENSES |
|
|
|
|
Cost of product sales and
rentals |
-- |
-- |
2 |
3 |
Research and development |
6,147 |
2,575 |
20,012 |
11,789 |
Selling, general and
administrative |
2,138 |
1,066 |
6,131 |
4,259 |
Total costs and expenses |
8,285 |
3,641 |
26,145 |
16,051 |
|
|
|
|
|
LOSS FROM OPERATIONS |
(8,285) |
(3,641) |
(26,143) |
(16,040) |
|
|
|
|
|
OTHER INCOME |
|
|
|
|
Decrease in fair value of
warrants |
2,241 |
1,367 |
3,289 |
3,331 |
Other income, net |
10 |
1 |
30 |
3 |
Total other income |
2,251 |
1,368 |
3,319 |
3,334 |
|
|
|
|
|
NET LOSS |
$ (6,034) |
$ (2,273) |
$ (22,824) |
$ (12,706) |
|
|
|
|
|
NET LOSS PER SHARE ATTRIBUTABLE TO
COMMON SHAREHOLDERS (Basic and Diluted) |
$ (0.17) |
$ (0.06) |
$ (0.63) |
$ (0.33) |
|
|
|
|
|
Weighted average number of common shares
outstanding (Basic and Diluted) |
43,336 |
60,847 |
40,331 |
50,517 |
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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