EXHIBIT 99.1
[AASTROM BIOSCIENCES INC LETTERHEAD]
P.O. Box 376 - Ann Arbor, Michigan 48106 - Ph: 734-930-5555 - Fax: 734-665-0485
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 THIRD QUARTER
FISCAL YEAR 2005 FINANCIAL RESULTS
ANN ARBOR, MICHIGAN, MAY 6, 2005 -- Aastrom Biosciences, Inc. (Nasdaq: ASTM)
today reported financial results for the third fiscal quarter ended March 31,
2005. The Company also reported several achievements of the last quarter, both
clinically and operationally. For the quarter ended March 31, 2005, these
achievements included:
- Clinical progress:
o Expanded U.S. Phase I/II clinical trial of the Company's
Tissue Repair Cell (TRC) product for severe long bone
fractures to include a third and fourth site: the Department
of Orthopedic Surgery at William Beaumont Hospital, Royal Oak,
MI and Lutheran Medical Center, Brooklyn, NY
o Achieved first FDA-required clinical benchmark for our Phase
I/II U.S. clinical trial of the Company's TRC product intended
for the treatment of severe long bone fractures. Successfully
met clinical safety endpoint for TRCs when used in bone graft
indications, which permits the Company to now treat
appendicular, or fresh, non-union fractures, opening the trial
to a larger patient population
o Completed enrollment in our lead feasibility study for use of
TRCs in jaw bone reconstruction for sinus lifts associated
with dental implants, initiated in Barcelona, Spain
- Patent award:
o Received patent from the U.S. Patent and Trademark Office that
provides expanded coverage for the Company's proprietary
single-pass perfusion technology to cover enhancing the
biological functionality of human dendritic cells produced in
cell culture
- New board member:
o Announced appointment of Warren "Chaunce" Bogard, Jr., Ph.D.,
to the Company's Board of Directors. Dr. Bogard is founder and
President of Bogard & Associates, a consulting firm dedicated
to assisting emerging biotechnology and healthcare companies
in general management, strategic planning, business
development and new product marketing
"We are continuing to achieve the operational milestones necessary to move our
technology toward the marketplace. In doing so, Aastrom is proactively
differentiating itself within the tissue regeneration sector, driven by our
ongoing clinical advancement," said R. Douglas Armstrong, Ph.D., Chief Executive
Officer and Chairman of Aastrom. "In addition, we continue to build and
strengthen the Aastrom team, and are very excited to have Dr. Bogard as the
newest member of our Board of Directors."
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Aastrom- 3rd Q FY2005 Fin Results
May 6, 2005
Page 2
FISCAL YEAR 2005 THIRD QUARTER ENDED MARCH 31, 2005 RESULTS
Total revenues for the quarter ended March 31, 2005, consisting of grant funding
and product sales and rentals, were $252,000 compared to $416,000 for the same
period in fiscal year 2004. Total revenues for the nine months ended March 31,
2005 were $0.8 million compared to $1.1 million for the same period in fiscal
year 2004.
Grant revenues decreased for the quarter and nine months ended March 31, 2005 to
$102,000 and $436,000, respectively, from $331,000 and $1.0 million for the same
periods in fiscal year 2004. Grant revenues have decreased from the prior year
as a result of reduced grant program activities; however, we continue to pursue
grant-funded programs.
Product sales and rentals increased to $150,000 and $377,000 for the quarter and
nine months ended March 31, 2005, respectively, from $10,000 and $45,000 for the
same periods in fiscal year 2004. The increase is due to increased volume of
therapy kit sales for clinical trials and research by others, and revenue from
the sale of an AastromReplicell(R) System that was delivered in the first
quarter of fiscal year 2005, recognized in this quarter, offset by a terminated
rental revenue source of $10,000 and $30,000 for the quarter and nine months,
respectively. Rental revenue is not expected in the future, subject to market
conditions. In addition, we plan to limit our marketing efforts promoting the
AastromReplicell System as a stand-alone product; rather we are focusing on
utilizing the AastromReplicell System technology to support our TRC development
programs. At such time as we satisfy applicable regulatory approval
requirements, we expect that sales of our TRCs and related cell-based products
will constitute nearly all of our product sales revenues.
Net loss for the quarter ended March 31, 2005 was $3.3 million, or $.03 per
share, compared to a net loss of $2.5 million, or $.03 per share for the same
period in fiscal year 2004. Net loss for the nine months ended March 31, 2005,
was $8.5 million, or $.09 per share, compared to $7.7 million or $.11 per share
for the same period in fiscal year 2004.
Total costs and expenses for the quarter ended March 31, 2005 were $3.8 million
compared to $2.9 million for the same period in fiscal year 2004. Total costs
and expenses for the nine months ended March 31, 2005 were $9.6 million,
compared to $8.9 million for the same period in fiscal year 2004.
Research and development expenses for the quarter ended March 31, 2005 increased
to $2.1 million, from $1.7 million for the same period in fiscal year 2004.
Research and development expenses for the nine months ended March 31, 2005
increased to $5.3 million, compared to $4.5 million for the same period in
fiscal year 2004. This increase reflects our increased research activities to
support regulatory submission approvals and anticipated product registrations,
product development activities in the area of tissue regeneration, development
of product distribution processes, and our ongoing and planned bone grafting
clinical trials in the United States and the EU.
Selling, general and administrative expenses increased to $1.6 million for the
quarter ended March 31, 2005, compared to $1.3 million for the same period in
fiscal year 2004. This increase is due to additional consulting and
pre-marketing activities in the United States and internationally, as well as
increased costs required for financial internal controls compliance and
certification. Selling, general and administrative expenses were $4.2 million
for the nine months ended March 31, 2005, unchanged from the same period in
fiscal year 2004.
The cost of product sales and rentals increased to $77,000 for the quarter ended
March 31, 2005, from $5,000, and increased to $131,000 for the nine months ended
March 31, 2005 from $22,000 for the same periods in fiscal year 2004. These
increases were due to an increase in volume of product sales.
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Aastrom- 3rd Q FY2005 Fin Results
May 6, 2005
Page 3
At March 31, 2005, the Company had $35.4 million in cash, cash equivalents and
short-term investments as compared to $16.9 million in cash and cash equivalents
at June 30, 2004.
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
third quarter fiscal year 2005 financial results and the Company's recent
progress and future goals today, May 6, 2005, at 11:00 a.m. (ET) when they will
host a conference call. Interested parties should call (785) 832-0326, 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=1054502, and
archived for replay at the same site for 90 days.
ABOUT AASTROM BIOSCIENCES, INC.
Aastrom Biosciences, Inc. (Nasdaq: ASTM) is developing patient-specific products
for the repair or regeneration of human tissues, utilizing the Company's
proprietary adult stem cell technology. Aastrom's strategic position in the
tissue regeneration sector is enabled by its proprietary Tissue Repair Cells
(TRCs), a mix of bone marrow-derived adult stem and progenitor cells, and the
AastromReplicell(R) System, an industry-unique automated cell production
platform used to produce cells for clinical use. TRCs are the core component of
the products Aastrom is developing for severe bone fractures, ischemic vascular
disease, jaw reconstruction and spine fusion, with Phase I/II level clinical
trials active in the U.S. and EU for some of these indications.
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, anticipated
components of revenue, 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 "intend," "planned,"
"planning," "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 --
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AASTROM BIOSCIENCES, INC.
(Unaudited)
CONSOLIDATED STATEMENTS OF OPERATIONS DATA:
Quarter ended March 31, Nine months ended March 31,
---------------------------------- ----------------------------------
2004 2005 2004 2005
------------- ------------- ------------- -------------
REVENUES:
Product sales and rentals $ 10,000 $ 150,000 $ 45,000 $ 377,000
Grants and other 406,000 102,000 1,047,000 436,000
------------- ------------- ------------- -------------
Total revenues 416,000 252,000 1,092,000 813,000
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COSTS AND EXPENSES:
Cost of product sales and rentals 5,000 77,000 22,000 131,000
Cost of product sales and rentals - provision
for obsolete and excess inventory -- 9,000 253,000 9,000
Research and development 1,660,000 2,095,000 4,471,000 5,258,000
Selling, general and administrative 1,279,000 1,624,000 4,200,000 4,227,000
------------- ------------- ------------- -------------
Total costs and expenses 2,944,000 3,805,000 8,946,000 9,625,000
------------- ------------- ------------- -------------
OTHER INCOME 28,000 204,000 113,000 361,000
------------- ------------- ------------- -------------
NET LOSS $ (2,500,000) $ (3,349,000) $ (7,741,000) $ (8,451,000)
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NET LOSS PER COMMON SHARE
(Basic and Diluted) $ (.03) $ (.03) $ (.11) $ (.09)
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Weighted average number of common shares
outstanding 72,204,000 100,140,000 71,384,000 90,719,000
============= ============= ============= =============
CONSOLIDATED BALANCE SHEET DATA:
June 30, March 31,
2004 2005
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ASSETS
Cash and investments $16,926,000 $35,435,000
Other current assets 906,000 956,000
Property, net 334,000 614,000
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Total assets $18,166,000 $37,005,000
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 558,000 $ 801,000
Shareholders' equity 17,608,000 36,204,000
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Total liabilities and shareholders' equity $18,166,000 $37,005,000
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