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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date
of report (date of earliest event reported):
November 9, 2006
Aastrom Biosciences, Inc.
(Exact name of registrant as specified in its charter)
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Michigan
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0-22025
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94-3096597 |
(State or other jurisdiction of
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(Commission File No.)
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(I.R.S. Employer |
incorporation)
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Identification No.) |
24 Frank Lloyd Wright Drive
P.O. Box 376
Ann Arbor, Michigan 48106
(Address of principal executive offices)
Registrants telephone number, including area code:
(734) 930-5555
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
TABLE OF CONTENTS
Item 2.02 Results of Operations and Financial Condition.
On November 9, 2006, we issued a press release announcing financial results and achievements for
our first fiscal quarter ended September 30, 2006. A copy of the press release is attached hereto
as Exhibit 99.1.
Pursuant to General Instruction B.2 of Form 8-K, this report and the exhibit are not deemed to be
filed for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall this report
and the exhibit be incorporated by reference into our filings under the Securities Act of 1933 or
the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such
future filing.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
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Exhibit No. |
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Description |
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99.1
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Press Release dated November 9, 2006 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: November 9, 2006
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AASTROM BIOSCIENCES, INC.
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By: |
/s/ Gerald D. Brennan, Jr.
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Gerald D. Brennan, Jr. |
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Vice President Administrative &
Financial Operations and CFO |
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exv99w1
Exhibit 99.1
FOR IMMEDIATE RELEASE
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CONTACTS:
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Kris M. Maly
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Cameron Associates |
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Investor Relations Department
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Kevin McGrath |
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Aastrom Biosciences, Inc.
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Phone: (212) 245-4577 |
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Phone: (734) 930-5777
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Deanne Eagle (Media) |
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Phone: (212) 554-5463 |
AASTROM BIOSCIENCES, INC. REPORTS FIRST QUARTER
FISCAL YEAR 2007 FINANCIAL RESULTS
Company Reports Clinical Progress and Strengthened Management Team
Ann Arbor, Michigan, November 9, 2006 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:
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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). |
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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. |
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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. |
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The appointment of two senior executives strengthened the management team. |
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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. |
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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 Companys 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 Aastroms TRC-based cell products, as well as the
Companys discovery and research efforts.
-more-
Aastrom-1st Q FY2007 Fin Results
November 9, 2006
Page 2
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, Aastroms 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 Officers
revised employment agreement, and an accrual and severance payments relating to the former
President and Chief Operating Officers 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.
-more-
Aastrom-1st Q FY2007 Fin Results
November 9, 2006
Page 3
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. Aastroms 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 Companys
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 Aastroms 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, 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 Aastroms Annual Report on Form
10-K and other filings with the Securities and Exchange Commission.
Financial Table Follows
-more-
AASTROM BIOSCIENCES, INC.
(Unaudited)
(In thousands, except per share amounts)
CONSOLIDATED STATEMENT OF OPERATIONS DATA:
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Quarter ended September 30, |
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2005 |
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2006 |
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REVENUES: |
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Product sales |
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15 |
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12 |
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Grants |
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165 |
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92 |
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Total revenues |
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180 |
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104 |
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COSTS AND EXPENSES: |
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Cost of product sales |
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5 |
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Research and development |
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1,953 |
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2,304 |
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Selling, general and administrative |
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2,016 |
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2,384 |
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Total costs and expenses |
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3,974 |
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4,688 |
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OTHER INCOME |
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306 |
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527 |
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NET LOSS |
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(3,488 |
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$ |
(4,057 |
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NET LOSS PER COMMON SHARE |
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(Basic and Diluted) |
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$ |
(.03 |
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(.03 |
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Weighted average number of common shares outstanding |
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102,483 |
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119,177 |
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CONSOLIDATED BALANCE SHEET DATA:
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June 30, |
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September 30, |
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2006 |
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2006 |
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ASSETS |
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Cash and cash equivalents |
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$ |
9,034 |
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$ |
11,724 |
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Short-term investments |
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33,963 |
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27,283 |
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Receivables, net |
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139 |
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104 |
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Inventories |
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1 |
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Other current assets |
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528 |
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819 |
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Property and equipment, net |
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1,216 |
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1,223 |
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Total assets |
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$ |
44,881 |
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$ |
41,153 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities |
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$ |
2,539 |
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$ |
2,141 |
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Shareholders equity |
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42,342 |
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39,012 |
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Total liabilities and shareholders equity |
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$ |
44,881 |
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$ |
41,153 |
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