(AASTROM BIOSCIENCES INC) P.O. Box 376 - Ann Arbor, Michigan 48106 -
Ph: 734-930-5555 - Fax: 734-665-0485
Located at: Domino's Farms, Lobby L EXHIBIT 99.1
FOR IMMEDIATE RELEASE
CONTACTS: Kris M. Maly or Becky Anderson Kevin McGrath
Investor Relations Department Cameron Associates
Aastrom Biosciences, Inc. (212) 245-4577
(734) 930-5777
AASTROM BIOSCIENCES, INC. REPORTS SECOND QUARTER
FISCAL YEAR 2005 FINANCIAL RESULTS
ANN ARBOR, MICHIGAN, FEBRUARY 4, 2005 -- Aastrom Biosciences, Inc. (NasdaqSC:
ASTM) today reported financial results for the second fiscal quarter ended
December 31, 2004. The Company also reported several achievements during the
last quarter, both clinically and operationally. For the quarter ended December
31, 2004, these achievements included:
- - Clinical update:
o Completion of patient treatments 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
o Signed a clinical trial agreement with the Heart and Diabetes Center
North Rhine-Westphalia, located in Bad Oeynhausen, Germany. The
clinical trial will evaluate the safety and effect of Aastrom's TRCs
in the regeneration of peripheral vascular tissue to treat lower
limb ischemia in diabetic patients
o Aastrom and the Institut de Terapia Regenerativa Tissular announced
the initiation of patient enrollment in a pilot clinical trial with
Instituto de Cirugia Maxilofacial e Implantologia in Barcelona,
Spain to determine the safety and effect of Aastrom's proprietary
TRCs in maxillary sinus lift bone graft procedures necessary for
dental implants
- - New management appointment - Aastrom appointed Gunter Rosskamp, Ph.D. as
Managing Director of its wholly owned German subsidiary, which supports
opportunities for the Company's research and development collaborations in
the EU, and the identification of commercial markets for Aastrom's
products and business
"Having completed the first half of our fiscal year, we are very encouraged with
the progress we are making clinically and operationally," said R. Douglas
Armstrong, Ph.D., Chief Executive Officer and Chairman of Aastrom. "One of the
best ways we can continue to build value for our shareholders is to be engaged
in clinical trials to determine the therapeutic effectiveness of our adult stem
cell technology. The early, important results seen in our Barcelona bone
fracture trial, along with the initiation of expanded clinical studies, are
bringing new interest and support to the Company, validating our business
strategy."
Dr. Armstrong continued, "Our shareholders should look for continued clinical
progress in the coming months, supported by disclosure of the results we will be
obtaining. We will expand our clinical programs, capitalizing on our leadership
in this industry which is based in part on our current clinical activity
utilizing our bone marrow-derived adult stem cells."
FISCAL YEAR 2005 SECOND QUARTER ENDED DECEMBER 31, 2004 RESULTS
Total revenues for the quarter ended December 31, 2004, consisting of product
sales and rentals in export markets and U.S. government agency grants, were
$374,000 compared to $376,000 for the
-more-
Aastrom- 2nd Q FY2005 Fin Results
February 4, 2005
Page 2
same period in fiscal year 2004. Total revenues for the six months ended
December 31, 2004 were $561,000 compared to $676,000 for the same period in
fiscal year 2004.
Net loss for the quarter ended December 31, 2004 was $2.5 million, or $.03 per
share, compared to a net loss of $2.4 million, or $.03 per share for the same
period in fiscal year 2004. Net loss for the six months ended December 31, 2004,
was $5.1 million, or $.06 per share, compared to $5.2 million, or $.07 per share
for the same period in fiscal year 2004.
At December 31, 2004, the Company had $22.6 million in cash, cash equivalents
and short-term investments as compared to $16.9 million in cash and cash
equivalents at June 30, 2004. The cash balance at December 31, 2004 does not
include the sale of 4.8 million shares of common stock for gross proceeds of $12
million to Fusion Capital Fund II, LLC, on January 10, 2005, pursuant to the
common stock purchase agreement dated October 30, 2002, or the exercise of
previously issued warrants to purchase 1.8 million shares of common stock for
gross proceeds of $2.9 million to date.
Total costs and expenses for the quarter ended December 31, 2004 were $2.9
million compared to $2.8 million for the same period in fiscal year 2004. Total
costs and expenses for the six months ended December 31, 2004 decreased to $5.8
million, compared to $6.0 million for the same period in fiscal year 2004.
Research and development expenses for the quarter ended December 31, 2004
increased slightly to $1.6 million, from $1.5 million for the same period in
fiscal year 2004. Research and development expenses for the six months ended
December 31, 2004 increased to $3.2 million, compared to $2.8 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 December 31, 2004, compared to $1.4 million for the same
period in fiscal year 2004. Selling, general and administrative expenses
decreased to $2.6 million for the six months ended December 31, 2004, from $2.9
million for the same period in fiscal year 2004. This decrease is primarily the
result of a $372,000 non-cash charge related to an employee performance-based
stock option that vested and a $53,000 non cash charge related to certain
warrants issued for public and investor relations services that were recorded in
the first quarter of fiscal year 2004.
"Our objective is to maintain a strong financial position as we proceed with our
current clinical trials, and advance new programs to the clinic," said Alan M.
Wright, Senior Vice President Administrative and Financial Operations and Chief
Financial Officer of Aastrom. "Our cash balance at the end of the second
quarter, combined with proceeds from the subsequent sales of common stock in
2005, comfortably supports the Company's operations through at least June 2006."
AASTROM CONFERENCE CALL INFORMATION
R. Douglas Armstrong, Ph.D., Chief Executive Officer and Chairman, Alan M.
Wright, Senior Vice President Administrative & Financial Operations and Chief
Financial Officer and James A. Cour, President and Chief Operating Officer of
Aastrom Biosciences, Inc., will review and discuss the second quarter fiscal
year 2005 financial results and the Company's recent progress and future goals
today, February 4, 2005, at 11:00 a.m. (EST) when they will host a conference
call. Interested parties should call (785) 832-0201, or toll-free (877)
707-9628, 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=1009961, and
archived for replay at the same site for 90 days.
-more-
Aastrom- 2nd Q FY2005 Fin Results
February 4, 2005
Page 3
ABOUT AASTROM BIOSCIENCES, INC.
Aastrom Biosciences, Inc. (NasdaqSC: ASTM) is developing treatments for the
repair of damaged human tissues and other medical disorders, or the generation
of normal human tissues, utilizing the Company's proprietary adult stem
cell-based products. 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), several of 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 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, plans for the
current fiscal year and potential product applications, which involve certain
risks and uncertainties. The forward-looking statements are also identified
through use of the words "expect," "intend," "planned," "can," "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 FORM 10-K AND OTHER
FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION.
-- Financial Table Follows --
AASTROM BIOSCIENCES, INC.
(Unaudited)
CONSOLIDATED STATEMENTS OF OPERATIONS DATA:
Quarter ended December 31, Six months ended December 31,
------------------------ --------------------------
2003 2004 2003 2004
---- ---- ---- ----
REVENUES:
Product sales and rentals $ 10,000 $ 212,000 $ 35,000 $ 227,000
Grants and other 366,000 162,000 641,000 334,000
------------ ------------ ------------ ------------
Total revenues 376,000 374,000 676,000 561,000
------------ ------------ ------------ ------------
COSTS AND EXPENSES:
Cost of product sales and rentals 5,000 39,000 17,000 54,000
Cost of product sales and rentals - provision
for obsolete and excess inventory -- -- 253,000 --
Research and development 1,455,000 1,596,000 2,811,000 3,163,000
Selling, general and administrative 1,356,000 1,289,000 2,921,000 2,603,000
------------ ------------ ------------ ------------
Total costs and expenses 2,816,000 2,924,000 6,002,000 5,820,000
------------ ------------ ------------ ------------
OTHER INCOME 37,000 97,000 85,000 157,000
------------ ------------ ------------ ------------
NET LOSS $ (2,403,000) $ (2,453,000) $ (5,241,000) $ (5,102,000)
============ ============ ============ ============
NET LOSS PER COMMON SHARE
(Basic and Diluted) $(.03) $ (.03) $ (.07) $ (.06)
============ ============ ============ ============
Weighted average number of common shares
outstanding 71,294,000 89,485,000 70,978,000 86,112,000
============ ============ ============ ============
CONSOLIDATED BALANCE SHEET DATA:
June 30, December 31,
2004 2004
---- ----
ASSETS
Cash and investments $16,926,000 $22,588,000
Other current assets 906,000 1,485,000
Property, net 334,000 466,000
----------- -----------
Total assets $18,166,000 $24,539,000
=========== ===========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 558,000 $ 690,000
Shareholders' equity 17,608,000 23,849,000
----------- -----------
Total liabilities and shareholders' equity $18,166,000 $24,539,000
=========== ===========
###