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Aastrom Biosciences, Inc. Reports First Quarter Fiscal Year 2005
Financial Results
ANN ARBOR, Mich., Nov. 4 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc.
(NASDAQ:ASTM) today reported financial results for the first fiscal quarter
ended September 30, 2004. The Company also reported several achievements
during the last quarter, both clinically and operationally. For the quarter
ended September 30, 2004, these achievements included:
* New management appointment - Janet M. Hock, B.D.S., Ph.D. named Vice
President Global Research, responsible for Aastrom's biological
research and clinical development programs. This appointment follows
the recent addition of James Cour as President and Chief Operating
Officer
* Research grant - award of a Phase I Small Business Innovation Research
grant entitled "Dendritic Cell Subset for Enhanced Cancer Vaccine" from
the National Institutes of Health National Cancer Institute. The eight-
month study will determine the efficacy and ability of the Company's
proprietary AastromReplicell(R) System to enhance the immunostimulatory
potency of dendritic cell-based cancer vaccines through its patented
single-pass perfusion technology
* Clinical update - completion of patient accrual for first phase of
clinical trial at Barcelona, Spain, for use of Aastrom's Tissue Repair
Cells (TRCs) in the regenerative repair of severe long bone non-union
fractures
"The progress of our lead adult stem cell TRC clinical program is driving our
emergence as a leading company in regenerative medicine, and contributes
greatly to our ability to attract high quality executive personnel, such as Dr.
Hock and Mr. Cour. Their contributions will be invaluable in bringing our
technology to the marketplace," commented R. Douglas Armstrong, Ph.D., Chief
Executive Officer and Chairman of Aastrom.
Dr. Armstrong continued, "Looking forward, we expect continued progress in the
clinic; for example the addition of clinical sites to our Phase I/II U.S.
multi-center trial for non-union tibial fractures, the completion of patient
enrollment into our recently announced clinical trial for the use of our TRCs
in maxillary sinus lift bone graft procedures in Spain, and the commencement of
our German clinical study evaluating the ability of TRCs to regenerate vascular
tissue in patients with diabetic limb ischemia. Our strategy of accessing
large, diverse therapeutic areas utilizing the same TRC technology is on track,
and as our portfolio of product candidates moves forward, we will focus our
efforts on developing the appropriate marketing partnerships for these
products."
First Quarter Fiscal Year 2005 ended September 30, 2004 Results
Total revenue for the quarter ended September 30, 2004, consisting of product
sales and rentals in the EU and grants, was $187,000 compared to $300,000 for
the same period in fiscal year 2004.
Net loss for the quarter ended September 30, 2004 was $2.65 million, or $.03
per share, compared to a net loss of $2.8 million, or $.04 per share for the
same period in fiscal year 2004.
At September 30, 2004, the Company had $15.0 million in cash, cash equivalents
and marketable securities as compared to $16.9 million in cash, cash
equivalents and marketable securities at September 30, 2003. The cash balance
at September 30, 2004 does not include proceeds from a $10 million sale of the
Company's common stock to institutional investors in a registered direct
placement completed in late October 2004.
Total costs and expenses for the quarter ended September 30, 2004 were $2.9
million compared to $3.2 million for the same period in fiscal year 2004.
Research and development expenses for the quarter ended September 30, 2004
increased slightly to $1.6 million, from $1.4 million for the same period in
fiscal year 2004. This increase reflects our continued research and product
development activities in the area of tissue regeneration, including our
ongoing and planned TRC clinical trials in the United States and the EU.
Selling, general and administrative expenses decreased slightly to $1.3 million
for the quarter ended September 30, 2004, compared to $1.6 million for the same
period in fiscal year 2004, primarily due to a non-recurring, non-cash
compensation expense recorded during the quarter ended September 30, 2004.
"Our increased financial resources place us in a better position to respond
operationally to any positive results from our ongoing clinical programs," said
Alan M. Wright, Senior Vice President Administrative and Financial Operations
and Chief Financial Officer of Aastrom.
Milestones Expected During Fiscal Year 2005
Aastrom entered fiscal year 2005 with sufficient funding to support planned
clinical and operational goals and objectives, including:
* Continued accrual of patients in our current FDA multi-center bone
graft trial in the U.S., and expansion to additional institutions as
clinical sites
* Expansion of clinical studies in Spain for bone grafting repair of
severe non-union fractures; pending positive results, move toward
commercialization in the EU
* Completion of a recently initiated jaw bone reconstruction clinical
trial in the EU for sinus lift procedures for dental implants; pending
positive results, move toward commercialization in the EU
* Initiation of an German clinical study to evaluate the ability of TRCs
to regenerate vascular tissue in patients with diabetic limb ischemia
* Pursuit of applicable opportunities for grants, to further define
potential uses and applications for our proprietary technology and cell
products
Aastrom Conference Call Information
R. Douglas Armstrong, Ph.D., Chief Executive Officer and Chairman and Alan M.
Wright, Senior Vice President Administrative & Financial Operations and Chief
Financial Officer of Aastrom Biosciences, Inc., will review and discuss the
first quarter fiscal year 2005 financial results and the Company's recent
progress and future goals today, November 4, 2004, at 11:00 a.m. (EST) when
they will host a conference call. Interested parties should call (785) 832-
0201, or toll-free (800) 223-9488, fifteen minutes before the start of the call
to register and identify themselves as registrants of the 'Aastrom Conference
Call'. The call will be simulcast on the web at
http://phx.corporate-ir.net/playerlink.zhtml?c=85924&s=wm&e=959337, and the
entire call will be archived for replay at the same site for 90 days.
About Aastrom Biosciences, Inc.
Aastrom Biosciences, Inc. (NASDAQ:ASTM) is a regenerative medicine company
developing proprietary adult stem cell-based products for the repair of damaged
human tissues and other medical disorders, or the generation of normal human
tissues. Aastrom's strategic position in the tissue regeneration and cell
therapy sectors is enabled by its proprietary Tissue Repair Cells (TRCs), a mix
of bone marrow stem and progenitor cells, and the AastromReplicell(R) System,
an industry-unique automated cell production platform used to produce cells for
clinical use. Together TRCs and the AastromReplicell System provide a
foundation that the Company is leveraging to produce multiple Prescription Cell
Products (PCPs), which are now in the clinical stage in the U.S. and EU. TRCs
are the core component of the PCPs Aastrom is developing for bone grafting,
peripheral vascular disease, jaw bone reconstruction and spine fusion markets.
The Company has also developed the AastromReplicell System for dendritic cell
production for researchers and institutions developing vaccines to treat cancer
and infectious diseases, under its Cell Production Products line.
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, the expected
adequacy of capital resources to support planned activities, expected
milestones and plans for the current fiscal year, potential product
applications, and potential advantages of the AastromReplicell System and
related cell therapy products, which involve certain risks and uncertainties.
The forward-looking statements are also identified through use of the words
"expect," "expected," "planned," "potential," "should," 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, 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 Form10-K and other filings with the
Securities and Exchange Commission.
CONSOLIDATED STATEMENT OF OPERATIONS DATA:
Quarter ended September 30,
2003 2004
REVENUES:
Product sales and rentals $25,000 $15,000
Grants and other 275,000 172,000
Total revenues 300,000 187,000
COSTS AND EXPENSES:
Cost of product sales and rentals 12,000 15,000
Cost of product sales and rentals - provision
for obsolete and excess inventory 253,000 --
Research and development 1,356,000 1,567,000
Selling, general and administrative 1,565,000 1,314,000
Total costs and expenses 3,186,000 2,896,000
OTHER INCOME 48,000 60,000
NET LOSS $ (2,838,000) $ (2,649,000)
NET LOSS PER COMMON SHARE
(Basic and Diluted) $(.04) $(.03)
Weighted average number of
common shares outstanding 70,662,000 82,738,000
CONSOLIDATED BALANCE SHEET DATA:
June 30, September 30,
2004 2004
ASSETS
Cash and investments $16,926,000 $14,995,000
Other current assets 906,000 1,690,000
Property and equipment, net 334,000 386,000
Total assets $18,166,000 $17,071,000
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $558,000 $779,000
Shareholders' equity 17,608,000 16,292,000
Total liabilities and shareholders'
equity $18,166,000 $17,071,000
DATASOURCE: Aastrom Biosciences, Inc.
CONTACT: Kris M. Maly or Becky Anderson, Investor Relations Department of
Aastrom Biosciences, Inc., +1-734-930-5777; or Kevin McGrath of Cameron
Associates, +1-212-245-4577
Web site: http://www.aastrom.com/