Preparing for Phase 3 Critical Limb Ischemia
Clinical Program
Company to Present Phase 2b CLI Interim Data at a
VEITHsymposium™ Satellite Session on November 18 at 1:00 p.m.
(ET)
Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of
expanded autologous cellular therapies for the treatment of severe
cardiovascular diseases, today reported operating results for the
quarter ended September 30, 2010. The company will hold a
conference call to discuss these results at 9:30 a.m. (ET) today;
log-in and dial-in information are listed at the end of this
announcement.
"This is an exciting time for Aastrom. We have made significant
progress in our late-stage clinical development programs. We
received Fast Track designation, and submitted documents in support
of a special protocol assessment (SPA) for our Phase 3 CLI program.
We also established a new partnership with ATEK Medical that will
enable us to grow and further advance our cell cassette
manufacturing capabilities. Finally, we strengthened our management
team and Board with industry veterans who will provide important
counsel as we move forward," said Tim Mayleben, president and CEO
of Aastrom Biosciences.
Aastrom will present data from an interim analysis of its Phase
2b RESTORE-CLI clinical trial at a VEITHsymposium™ non-CME
satellite session on November 18 at 1:00 p.m. (ET). This event
will include a webcast presentation by Dr. Richard Powell,
RESTORE-CLI Principal Investigator, and a Q&A session with Dr.
Powell, CEO Tim Mayleben and Dr. Sharon Watling, vice president
clinical and regulatory at Aastrom Biosciences. Details on the
webcast and conference call, including log-in and dial-in
information, will be made available at www.aastrom.com/investor.cfm
approximately one week before the event.
Operating Results for the Quarter ended September 30, 2010
As of September 30, 2010, the company had a total of
approximately $14.5 million in cash and cash equivalents, compared
to $19.1 million in cash, cash equivalents and short-term
investments at June 30, 2010. The primary use of cash, cash
equivalents and short-term investments during the quarter ended
September 30, 2010 was to finance operations, working capital
requirements and capital expenditures.
Research and development expenses for the quarter ended
September 30, 2010 were $4.2 million, compared to $2.9 million for
the same period in 2009. This increase was associated with
preparations for the Phase 3 CLI development program.
Selling, general and administrative expenses for the quarter
ended September 30, 2010 were $1.7 million, compared to $0.9
million for the same period in 2009. This change is due to a $0.4
million increase in non-cash stock-based compensation expense with
the remainder primarily due to higher employee expenses and general
consulting.
Net loss for the quarter ended September 30, 2010 was $5.8
million, or $0.21 per share, compared to a net loss of $3.8
million, or $0.18 per share, for the same period in 2009. The
increase in net loss is due to the fluctuations in research and
development expenses and selling, general and administrative
expenses as described above. Loss per share comparisons were
impacted by the issuance of 6.5 million shares of common stock on
January 21, 2010.
Aastrom Conference Call Information
Tim M. Mayleben, president and CEO and Scott C. Durbin, chief
financial officer, will host a conference call to review and
discuss the September 30, 2010 operating results at 9:30 a.m. (ET)
today, November 8, 2010. Interested parties should call toll-free
(877) 312-5881, or from outside the U.S. (253) 237-1173, and
reference Aastrom's first quarter conference call. The call
will be available live at www.aastrom.com/investor.cfm. Please
access the site at least 15 minutes prior to the scheduled start
time in order to download the required audio software if necessary
(RealPlayer or Windows Media Player). A podcast of the call will
also be available after the live event at
http://www.aastrom.com/events.cfm. If you are unable to participate
during the live call, the webcast will be available for replay at
http://www.aastrom.com/events.cfm until February 8, 2011. An audio
replay of the call will be available until 12:00 am (ET) on
November 15, 2010 by calling (800) 642-1687, or from outside the
U.S. at (706) 645-9291. The passcode for the replay is
17933343.
About Aastrom Biosciences
Aastrom Biosciences is an emerging biotechnology company
developing expanded autologous cellular therapies for use in the
treatment of severe cardiovascular diseases. The company's
proprietary cell-processing technology enables the manufacture of
mixed-cell therapies expanded from a patient's own bone marrow and
delivered directly to damaged tissues. Aastrom has advanced its
cell therapies into late-stage clinical development, including a
planned Phase 3 clinical program for the treatment of patients with
critical limb ischemia and two ongoing Phase 2 clinical trials in
patients with 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,
objectives and expectations, clinical activity timing, intended
product development, disease treatment and progression, patient
symptoms and responses to treatment, development of supplier
relationships, treatment options 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) |
|
|
|
|
|
|
CONSOLIDATED CONDENSED
BALANCE SHEETS (Unaudited) |
|
|
|
|
June 30, 2010 |
September 30, 2010 |
|
|
|
ASSETS: |
|
|
Cash and cash equivalents |
$14,119 |
$14,466 |
Short-term investments |
5,000 |
-- |
Other current assets |
399 |
522 |
Property and equipment, net |
1,013 |
982 |
|
|
|
Total assets |
$20,531 |
$15,970 |
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY: |
|
|
Current liabilities |
$2,661 |
$3,487 |
Long-term debt |
79 |
40 |
Shareholders' equity |
17,791 |
12,443 |
|
|
|
Total liabilities and shareholders'
equity |
$20,531 |
$15,970 |
|
|
|
CONSOLIDATED CONDENSED
STATEMENTS OF OPERATIONS (Unaudited) |
|
|
|
|
|
|
Quarter ended September
30, |
|
2009 |
2010 |
|
|
|
REVENUES: |
|
|
Total revenue |
$73 |
$ -- |
|
|
|
|
|
|
COSTS AND EXPENSES: |
|
|
Cost of product sales and rentals |
32 |
-- |
Research and development |
2,911 |
4,167 |
Selling, general and administrative |
946 |
1,686 |
|
|
|
Total costs and expenses |
3,889 |
5,853 |
|
|
|
OTHER INCOME (EXPENSE): |
|
|
Total other income (net) |
15 |
20 |
|
|
|
NET LOSS |
$ (3,801) |
$ (5,833) |
NET LOSS PER SHARE |
|
|
(Basic and Diluted) |
$ (0.18) |
$ (0.21) |
Weighted average number of common shares
outstanding (Basic and Diluted) |
20,679 |
28,255 |
CONTACT: Berry & Company
Media contact
Stephen Zoegall
212 253-8881
szoegall@berrypr.com
Aastrom Biosciences
Investor Contact
Kimberli O'Meara
734 930-5777
ir@aastrom.com
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Jun 2024 to Jul 2024
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Jul 2023 to Jul 2024