- Company Reports Clinical Progress and Strengthened Management
Team - ANN ARBOR, Mich., Nov. 9 /PRNewswire-FirstCall/ -- Aastrom
Biosciences, Inc. (NASDAQ:ASTM), a late-stage development company
focused on the use of autologous cells for regenerative medicine,
today reported financial results for the first fiscal quarter ended
September 30, 2006. The Company also reported clinical and
operational achievements during the quarter, including: (Logo:
http://www.newscom.com/cgi-bin/prnh/20060302/NETH028LOGO ) *
Additional interim results from 23 patients enrolled in the U.S.
Phase I/II multi-center clinical trial for the treatment of severe
long bone non-union fractures were presented by one of the
Principal Investigators, Thomas R. Lyon, M.D., Chief of Orthopedic
Trauma & Clinical Instructor of Orthopedic Surgery at Lutheran
Medical Center, in Brooklyn, New York, at the 28th Annual Meeting
of the American Society for Bone and Mineral Research (ASBMR). -
After being treated with the TRC-based cell product, callus
formation was observed in 22 of the 23 patients by six months.
Callus formation is the first sign of healing and return of blood
flow. - Of these 23 patients, 12 have completed the total one year
follow-up observation period. Ten of these 12 patients showed bone
bridging at the fracture site, indicating radiographic evidence of
healing. * The appointment of two senior executives strengthened
the management team. - George W. Dunbar as President, Chief
Executive Officer and Director. Mr. Dunbar brings over 25 years of
experience in the healthcare field to the Company, including 15
years in the role of Chief Executive Officer at both established
and early-stage healthcare companies in the biotech,
pharmaceutical, diagnostic and device sectors. - Elmar R.
Burchardt, M.D., Ph.D., as Vice President Medical Affairs. Dr.
Burchardt is responsible for directing all of the clinical programs
utilizing the Company's proprietary TRC technology, including
programs for long bone fractures, critical limb ischemia, spine
fusion and osteonecrosis. He will also lead the development of new
indication programs, such as a program for cardiac tissue
regeneration. Following the end of the first fiscal quarter, the
Company also announced that Ronnda L. Bartel, Ph.D. has joined
Aastrom as Vice President of Research and Development. Dr. Bartel
is responsible for the product development and manufacturing of
Aastrom's TRC-based cell products, as well as the Company's
discovery and research efforts. "We are determined to provide our
TRC-based cell products to physicians and their patients who are in
need of new medical approaches for tissue regeneration. We are
currently in clinical trials utilizing our platform technology to
address regenerative medicine needs in the vascular and bone areas,
and are also preparing to move into additional therapeutic areas,
including cardiac and neural regeneration," stated Mr. Dunbar. "At
this time, Aastrom's value lies in achieving clinical milestones.
Under the direction of our strengthened management team, we look
forward to reporting on the clinical progress we have slated for
accomplishment by the end of 2007." First Fiscal Quarter Ended
September 30, 2006 Results Total revenues for the quarter ended
September 30, 2006, consisting of product sales and grant funding,
were $104,000, compared to total revenues of $180,000 for the same
period in fiscal year 2006. Product sales for the quarter ended
September 30, 2006, consisting of the sale of therapy kits for
clinical trials and research by others, decreased slightly to
$12,000 from $15,000 for the same period in fiscal year 2006. Grant
revenues decreased to $92,000 for the quarter ended September 30,
2006 from $165,000 for the same period in fiscal year 2006. This
decrease is the result of slightly lower grant program activities,
and the completion of our activity on the collaborative grant with
the Defense Advanced Research Projects Agency (DARPA) in June 2006.
Grant revenues accounted for 88% of total revenues for the quarter
ended September 30, 2006 and 92% of total revenues for the same
period in fiscal year 2006, and are recorded on a
cost-reimbursement basis. As we continue to pursue grant-funding,
grant revenues may vary in any period based on timing of grant
awards, grant-funded activities, level of grant funding and number
of grant awards received. Total costs and expenses increased to
$4,688,000 for the quarter ended September 30, 2006, from
$3,974,000 for the same period in fiscal year 2006. The cost of
product sales decreased to $0 for the quarter ended September 30,
2006 from $5,000 for the same period in fiscal year 2006. Research
and development expenses increased to $2,304,000 for the quarter
ended September 30, 2006 from $1,953,000 for the same period in
fiscal year 2006. This increase reflects continued expansion of our
research activities to support future regulatory submissions,
on-going and planned tissue regeneration clinical trials in the
U.S. and EU and the development of facilities for product
manufacturing. Research and development expenses for the quarters
ended September 30, 2006 and 2005, also include a non-cash charge
of $108,000 and $78,000, respectively, relating to share-based
compensation expense. Selling, general and administrative costs
increased to $2,384,000 for the quarter ended September 30, 2006
from $2,016,000 for the same period in fiscal year 2006. This
increase is due to additional employee costs that include: an
accrual relating to the former Chief Executive Officer's revised
employment agreement, and an accrual and severance payments
relating to the former President and Chief Operating Officer's
employment agreement. Selling, general and administrative expenses
for the quarters ended September 30, 2006 and 2005, also include a
non-cash charge of $463,000 and $118,000, respectively, relating to
share-based compensation expense. Interest income was $527,000 for
the quarter ended September 30, 2006 compared to $306,000 for the
same period in fiscal year 2006. The fluctuations in interest
income are due primarily to corresponding changes in the level of
cash, cash equivalents and short-term investments during the
periods and improved yields from our investments. Net loss for the
quarter ended September 30, 2006 was $4,057,000, or $.03 per common
share compared to $3,488,000 or $.03 per common share for the same
period in fiscal year 2006. The increase in net loss is primarily
the result of increased costs and expenses offset on a per share
basis by an increase in the weighted average number of common
shares outstanding. At September 30, 2006, the Company had $39
million in cash, cash equivalents and short-term investments as
compared to $43 million at June 30, 2006. Aastrom Conference Call
Information George W. Dunbar, President and Chief Executive
Officer, Gerald D. Brennan, Jr., Vice President Administrative
& Financial Operations and Chief Financial Officer, and Elmar
R. Burchardt, M.D., Ph.D., Vice President Medical Affairs of
Aastrom Biosciences, Inc., will host a conference call to review
and discuss the first quarter fiscal year 2007 financial results at
11:00 a.m. (EST) today, November 9, 2006. Interested parties should
call toll-free (877) 407-9205, or from outside the U.S. (201)
689-8054, fifteen minutes before the start of the call to register
and identify themselves as registrants of the 'Aastrom Conference
Call'. Any registered caller on the toll-free line may ask to be
placed in the queue for the Question & Answer session. The call
will be simulcast on the web at
http://www.vcall.com/IC/CEPage.asp?ID=109389 . A podcast of the
call may be downloaded from the web at the internet address above.
If you are unable to participate during the live call, the webcast
will be available for replay at http://www.investorcalendar.com/
for 60 days. Also, through November 19, 2006, an audio replay of
the call will be available by dialing toll-free (877) 660-6853, or
from outside the U.S. (201) 612-7415; when prompted on the phone
line, the Account # is: 286 and the Conference ID# is: 215272.
About Aastrom Biosciences, Inc. Aastrom Biosciences, Inc.
(NASDAQ:ASTM) is developing autologous cell products for the repair
or regeneration of multiple human tissues, based on its proprietary
Tissue Repair Cell (TRC) technology. Aastrom's TRC-based products
are a unique cell mixture containing stromal, stem and progenitor
cell populations, produced outside the body from a small amount of
bone marrow taken from the patient. TRC-based products have been
used in over 230 patients, and are currently in clinical trials for
bone regeneration (long bone fractures and spine fusion) and
vascular regeneration (critical limb ischemia) applications. The
Company has reported positive interim clinical trial results for
TRCs suggesting both the clinical safety and the ability of TRCs to
induce tissue regeneration in long bone fractures and jaw bone
reconstruction. The Company's proprietary TRCs received an Orphan
Drug Designation from the U.S. Food and Drug Administration (FDA)
for use in the treatment of osteonecrosis of the femoral head. In
addition, Aastrom is developing plans for a TRC-based therapy for
cardiac regeneration. For more information, visit Aastrom's website
at http://www.aastrom.com/ . This document contains forward-looking
statements, including without limitation, statements concerning
clinical trial plans and expectations, intended product development
and commercialization objectives, and potential product
applications, which involve certain risks and uncertainties. The
forward-looking statements are also identified through use of the
words "may," "planned," "plans," and other words of similar
meaning. 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 and other filings with the
Securities and Exchange Commission. CONTACTS: Kris M. Maly Cameron
Associates Investor Relations Department Kevin McGrath Aastrom
Biosciences, Inc. Phone: (212) 245-4577 Phone: (734) 930-5777
Deanne Eagle (Media) Phone: (212) 554-5463 AASTROM BIOSCIENCES,
INC. (Unaudited) (In thousands, except per share amounts)
CONSOLIDATED STATEMENT OF OPERATIONS DATA: Quarter ended September
30, ------------ 2005 2006 ----- ----- REVENUES: Product sales $15
$12 Grants 165 92 ----- ----- Total revenues 180 104 ----- -----
COSTS AND EXPENSES: Cost of product sales 5 - Research and
development 1,953 2,304 Selling, general and administrative 2,016
2,384 ----- ----- Total costs and expenses 3,974 4,688 ----- -----
OTHER INCOME 306 527 ----- ----- NET LOSS $ (3,488) $ (4,057) -----
----- ----- ----- NET LOSS PER COMMON SHARE (Basic and Diluted)
$(.03) $(.03) ----- ----- ----- ----- Weighted average number of
common shares outstanding 102,483 119,177 ----- ----- ----- -----
CONSOLIDATED BALANCE SHEET DATA: June 30, September 30, 2006 2006
----- ----- ASSETS Cash and cash equivalents $9,034 $11,724
Short-term investments 33,963 27,283 Receivables, net 139 104
Inventories 1 - Other current assets 528 819 Property and
equipment, net 1,216 1,223 ----- ----- Total assets $ 44,881 $
41,153 ----- ----- ----- ----- LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $2,539 $2,141 Shareholders' equity 42,342
39,012 ----- ----- Total liabilities and shareholders' equity $
44,881 $ 41,153 ----- ----- ----- -----
http://www.newscom.com/cgi-bin/prnh/20060302/NETH028LOGO
http://photoarchive.ap.org/ DATASOURCE: Aastrom Biosciences, Inc.
CONTACT: Kris M. Maly, Investor Relations Department of Aastrom
Biosciences, Inc., +1-734-930-5777; or Media, Kevin McGrath,
+1-212-245-4577, or Deanne Eagle, +1-212-554-5463, both of Cameron
Associates for Aastrom Biosciences, Inc. Web site:
http://www.aastrom.com/
http://www.vcall.com/IC/CEPage.asp?ID=109389
http://www.investorcalendar.com/
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