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 ended March 31, 2014.
Aastrom reported a net loss for the quarter ended March 31, 2014
of $6.0 million, or $1.26 per share, compared to $5.5 million, or
$3.00 per share, for the same period a year ago. The change in net
loss from the prior year is due primarily to the non-cash change in
the fair value of warrants and decreases in both research and
development and selling, general and administrative expenses.
Research and development expenses for the quarter ended March
31, 2014 were $3.3 million versus $5.5 million for the same period
a year ago. The decrease in expenses is due primarily to a
reduction in clinical trial expenses and the execution of a
corporate restructuring that substantially reduced headcount and
operating expenses.
General and administrative expenses for the quarter ended March
31, 2014 were $1.4 million compared to $1.6 million for the same
period a year ago. The decrease in expenses is due primarily to the
reduction of operating expenses resulting from the corporate
restructuring.
Other income (expense) for the quarter ended March 31, 2014 was
($1.4) million compared to $1.6 million for the same period a year
ago. The decrease in other income is due primarily to the non-cash
change in the fair value of warrants due to the increase in
Aastrom's stock price, the issuance of the August 2013 warrants,
the adjustment to the fair value due to the exercise of warrants in
March 2014, and the reduction in the time to maturity for the
warrants.
As of March 31, 2014, the company had $8.8 million in cash and
cash equivalents, compared to $8.1 million in cash and cash
equivalents at December 31, 2013, and approximately $8.7 million in
cash and cash equivalents as of April 30, 2014. For the quarter
ended March 31, 2014, cash used for operations was $4.7
million.
Recent Business Highlights
During and since the first quarter of 2014, the company has:
- entered into a definitive agreement to acquire Sanofi's Cell
Therapy and Regenerative Medicine (CTRM) business;
- entered into a $15 million equity commitment with Lincoln Park
Capital;
- continued site activation and enrollment of patients in the
Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T for the
treatment of advanced heart failure due to ischemic dilated
cardiomyopathy (DCM);
- announced that the independent Data and Safety Monitoring Board
(DSMB) for the ixCELL-DCM clinical trial recommended continuing the
study without modification following an interim review of unblinded
safety data from the trial;
- conducted preliminary analysis of data from patients in the
REVIVE CLI study, which showed positive trends in amputation-free
survival and wound closure, consistent with previous results; the
company plans to maintain its current clinical development strategy
for ixmyelocel-T; and
- announced the appointment of Dr. Ross Tubo as chief scientific
officer and Dr. David Recker as chief medical officer of
Aastrom.
"The acquisition of Sanofi's CTRM business represents a unique
opportunity to strengthen our leadership position in the field of
regenerative medicine and accelerate our forward integration as we
develop ixmyelocel-T for the treatment of advanced heart failure
due to ischemic DCM and other severe conditions," said Nick
Colangelo, president and chief executive officer of Aastrom. "With
this acquisition and the recent actions we have taken to strengthen
our company, we are well-positioned to realize our clinical and
commercial goals. We look forward to building on Sanofi's record of
success in the autologous cell therapy field as we unite our
operations to maximize the potential of our combined commercial and
pipeline products to drive growth in the years ahead."
Conference Call Information
Aastrom's management will host a conference call to discuss
these results on Thursday, May 15, 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 44774762.
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 19, 2014 by calling
(855) 859-2056, or from outside the U.S. at (404) 537-3406 and
using conference ID 44774762. The webcast will also be available
after the live event at http://investors.aastrom.com/events.cfm
until May 15, 2015.
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 advanced heart failure due to 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, anticipated milestones, potential
advantages of our product candidates and the timing and ability of
Aastrom to close the acquisition of Sanofi's Cell Therapy and
Regenerative Medicine business pursuant to Aastrom's Asset Purchase
Agreement with Sanofi, 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 acquisition of Sanofi's Cell Therapy and
Regenerative Medicine business, 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 for the year ended December
31, 2013, filed with the Securities and Exchange Commission ("SEC")
on March 13, 2014, Quarterly Reports on Form 10-Q and other filings
with the SEC. 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.
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|
|
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AASTROM BIOSCIENCES,
INC. |
(in thousands, except
per share amounts) |
|
|
|
CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) |
|
|
|
|
December 31,
2013 |
March 31, 2014 |
ASSETS |
|
|
Cash |
$8,059 |
$8,836 |
Other current assets |
417 |
400 |
Property and equipment,
net |
739 |
642 |
Total assets |
$9,215 |
$9,878 |
|
|
|
LIABILITIES AND SHAREHOLDERS'
EQUITY |
|
|
Warrant liabilities |
$2,019 |
$3,226 |
Other current
liabilities |
3,296 |
2,881 |
Current portion of long-term
debt |
6 |
2 |
Shareholders' equity |
3,894 |
3,769 |
Total liabilities and
shareholders' equity |
$9,215 |
$9,878 |
|
|
|
|
|
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) |
|
|
|
|
Quarter Ended
March 31, |
|
2013
|
2014 |
|
|
|
REVENUES |
$ 8 |
$ -- |
|
|
|
COSTS AND EXPENSES |
|
|
Cost of product sales and
rentals |
2 |
-- |
Research and development |
5,538 |
3,271 |
Selling, general and
administrative |
1,633 |
1,374 |
|
|
|
Total costs and
expenses |
7,173 |
4,645 |
|
|
|
LOSS FROM OPERATIONS |
(7,165) |
(4,645) |
|
|
|
OTHER INCOME (EXPENSE) |
|
|
(Increase) decrease in fair
value of warrants |
1,619 |
(1,352) |
Other income, net |
2 |
2 |
Total other income
(expense) |
1,621 |
(1,350) |
|
|
|
NET LOSS |
$ (5,544) |
$ (5,995) |
|
|
|
NET LOSS PER SHARE ATTRIBUTABLE TO
COMMON SHAREHOLDERS (Basic and Diluted) |
$ (3.00) |
$ (1.26) |
|
|
|
Weighted average number of common shares
outstanding (Basic and Diluted) |
2,243 |
5,868 |
CONTACT: Media contact:
David Salisbury
Berry & Company
dsalisbury@berrypr.com
(212) 253-8881
Investor contact:
Chad Rubin
The Trout Group
crubin@troutgroup.com
(646) 378-2947
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