e8vk
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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, 2007
Aastrom Biosciences, Inc.
(Exact name of registrant as specified in its charter)
|
|
|
|
|
Michigan
|
|
0-22025
|
|
94-3096597 |
(State or other
jurisdiction of
incorporation)
|
|
(Commission File No.)
|
|
(I.R.S. Employer
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)) |
Item 2.02 Results of Operations and Financial Condition.
On November 9, 2007, we issued a press release announcing financial results and achievements for
our first fiscal quarter ended September 30, 2007. 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.
|
|
|
|
|
Exhibit No. |
|
Description |
|
99.1 |
|
|
Press Release dated November 9, 2007 |
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, 2007
|
|
|
|
|
|
AASTROM BIOSCIENCES, INC.
|
|
|
By: |
/s/ Gerald D. Brennan, Jr.
|
|
|
|
Gerald D. Brennan, Jr. |
|
|
|
Vice President, Administrative &
Financial Operations and CFO |
|
|
2
exv99w1
Exhibit 99.1
FOR IMMEDIATE RELEASE
|
|
|
|
|
CONTACTS:
|
|
Kris M. Maly
|
|
Cameron Associates |
|
|
Investor Relations Department
|
|
Kevin McGrath |
|
|
Aastrom Biosciences, Inc.
|
|
Phone: (212) 245-4577 |
|
|
Phone: (734) 930-5777 |
|
|
AASTROM BIOSCIENCES, INC. REPORTS FIRST QUARTER
FISCAL YEAR 2008 FINANCIAL RESULTS
Clinical Progress Reported from Tissue Regeneration Programs
Ann Arbor, Michigan, November 9, 2007 Aastrom Biosciences, Inc. (Nasdaq: ASTM), a leading
regenerative medicine company, today reported financial results for the first fiscal quarter ended
September 30, 2007. The Company also reported clinical and operational achievements since the
beginning of fiscal year 2008, including:
|
|
|
Positive final results from a U.S. Phase I/II clinical trial designed to collect safety
and efficacy data utilizing Bone Repair Cells (BRCs) in the treatment of severe non-union
fractures were presented by Matthew L. Jimenez, M.D., of the Illinois Bone & Joint
Institute, during a podium presentation at the Orthopaedic Trauma Association annual
meeting in Boston, MA: |
|
|
|
Overall 91% healing rate in 30 of 33 patients with non-union tibia,
humerus or femur fractures that had failed to heal after one or more prior medical
procedures (average 1.75) one year post-BRC treatment |
|
|
|
|
100% of the patients who have healed are fully weight-bearing, have
regained range of motion and are no longer impaired by their injuries |
|
|
|
|
Severe bone fracture results supported bone regeneration proof of
principle and the initiation of Aastroms U.S. Phase III osteonecrosis of the
femoral head clinical trial |
|
|
|
Encouraging interim results from two German research groups utilizing Aastroms
proprietary Tissue Repair Cell (TRC) Technology platform to manufacture autologous stem
cell products were presented at the 2nd Congress of the German Society for Stem Cell
Research in Würzburg, Germany: |
|
|
|
Interim results from the first 13 patients treated in a multi-arm,
Phase I/II, single-center clinical trial to evaluate the safety of Vascular Repair
Cells (VRCs) and normal bone marrow cells in the treatment of chronic diabetic foot
wounds associated with critical limb ischemia (CLI) were presented by Dr. Bernd
Stratmann of the Diabetes Center at the Heart and Diabetes Center in North
Rhine-Westphalia (Center), Bad Oeynhausen, Germany. Twelve months post-treatment,
all four patients in the interim analysis who were treated with VRCs reported no
major amputations, no cell-related adverse events, and healing of all open wounds. |
|
|
|
|
Early clinical data involving the first use of Aastrom BRCs to treat
patients suffering from osteonecrosis of the femoral head were presented by Ulrich
Nöth, M.D. of the Orthopaedic Institute, König-Ludwig-Haus, University of Würzburg,
Germany. All four patients tolerated the procedure well, have reported a reduction
in hip pain with no signs of disease progression, as determined by MRI and X-Ray,
and were back to |
-more-
Aastrom-1st Q FY2008 Fin Results
November 9, 2007
Page 2
|
|
|
work within 6 months after treatment. In addition, no cell-related adverse
events were reported and none of these patients have required hip replacement
surgery. |
|
|
|
Completion of a registered direct offering to a select group of unaffiliated
institutional investors through BMO Capital Markets Corp. for net proceeds of approximately
$12.5 million |
Overall, we are very pleased with our accomplishments since the beginning of this fiscal year.
The positive clinical results reported from our bone and vascular regeneration programs continue to
support our proprietary TRC Technology as a novel platform for the production of high-value
patient-specific therapeutics, said George Dunbar, President and Chief Executive Officer of
Aastrom. We remain committed to furthering all of our tissue regeneration programs, and look
forward to reporting future developments from our planned cardiac and neural clinical activities.
First Fiscal Quarter Ended September 30, 2007 Results
Total revenues for the quarter ended September 30, 2007, consisting of grant revenues and product
sales, were $87,000, compared to total revenues of $104,000 for the same period in fiscal year
2007.
Total costs and expenses increased to $5,487,000 for the quarter ended September 30, 2007, from
$4,688,000 for the same period in fiscal year 2007.
As a result of the continued expansion of research and development activities to support regulatory
submissions, on-going and planned tissue regeneration clinical trials and activities in the U.S.
and EU, and the development of facilities for product manufacturing and distribution processes,
research and development expenses increased to $3,873,000 for the quarter ended September 30, 2007
from $2,304,000 for the same period in fiscal year 2007. Research and development expenses for the
quarters ended September 30, 2007 and 2006, also include a non-cash charge of $224,000 and
$108,000, respectively, relating to share-based compensation expense.
Selling, general and administrative expenses decreased to $1,614,000 for the quarter ended
September 30, 2007 from $2,384,000 for the same period in fiscal year 2007. This decrease is
primarily due to additional employee costs for the quarter ended September 30, 2006 that included:
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. The quarter ended September 30, 2007 did not include any such charges.
Selling, general and administrative expenses for the quarters ended September 30, 2007 and 2006,
also include a non-cash charge of $326,000 and $463,000, respectively, relating to share-based
compensation expense.
Interest income was $365,000 for the quarter ended September 30, 2007 compared to $527,000 for the
same period in fiscal year 2007. 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 varying yields from our investments.
Interest expense was $15,000 for the quarter ended September 30, 2007 related to long-term debt for
equipment acquired during the fiscal year ended June 30, 2007.
Net loss for the quarter ended September 30, 2007 was $5,050,000, or $.04 per common share compared
to $4,057,000, or $.03 per common share for the same period in fiscal year 2007. The increase in
net loss is primarily the result of increased costs and expenses offset in part on a per share
basis by an increase in the weighted average number of common shares outstanding.
At September 30, 2007, the Company had $24.3 million in cash, cash equivalents and short-term
investments as compared to $28.3 million at June 30, 2007. Subsequently, on October 17, 2007, the
-more-
Aastrom-1st Q FY2008 Fin Results
November 9, 2007
Page 3
Company completed a registered direct offering of its common shares for net cash proceeds of
approximately $12.5 million. As clinical activities expand, it is expected that the Companys cash
utilization will average $1.7 million per month during fiscal year 2008.
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, will host a conference call to
review and discuss the first quarter fiscal year 2008 financial results at 9:00 a.m. (EST) today,
November 9, 2007. 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=122490. 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/ until
February 10, 2008. Also, through November 19, 2007, 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: 259840.
About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration
of human tissue. The companys proprietary Tissue Repair Cell (TRC) Technology involves the use of
a patients own cells to manufacture products to treat a range of chronic diseases and serious
injuries affecting bone, vascular, cardiac, and neural tissues. Aastroms TRC-based products
contain increased numbers of stem and early progenitor cells, produced from a small amount of bone
marrow collected from the patient. The TRC Technology platform has positioned Aastrom to advance
multiple products into clinical development. Currently, the company has a bone regeneration product
in Phase III development for the treatment of osteonecrosis of the femoral head (called the ON-CORE
trial), a vascular regeneration product in clinical development for the treatment of critical limb
ischemia (called the RESTORE-CLI trial), and preclinical research programs targeting unmet needs in
cardiac and neural health. Aastrom product candidates to treat osteonecrosis of the femoral head
and dilated cardiomyopathy have been designated for orphan drug status by the FDA. For more
information, visit Aastroms website at www.aastrom.com. (astmf)
This document contains forward-looking statements, including without limitation, statements
concerning clinical trial plans and expectations, clinical activity timing, intended product
development and commercialization objectives, and potential advantages and application of Tissue
Repair Cell (TRC) Technology, which involve certain risks and uncertainties. The forward-looking
statements are also identified through use of the word planned, 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:
|
|
|
|
|
|
|
|
|
|
|
Quarter ended September 30, |
|
|
|
2006 |
|
|
2007 |
|
REVENUES: |
|
|
|
|
|
|
|
|
Product sales |
|
$ |
12 |
|
|
$ |
12 |
|
Grants |
|
|
92 |
|
|
|
75 |
|
|
|
|
|
|
|
|
Total revenues |
|
|
104 |
|
|
|
87 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COSTS AND EXPENSES: |
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
|
|
|
|
|
|
Research and development |
|
|
2,304 |
|
|
|
3,873 |
|
Selling, general and administrative |
|
|
2,384 |
|
|
|
1,614 |
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
4,688 |
|
|
|
5,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
|
|
|
|
|
Interest income |
|
|
527 |
|
|
|
365 |
|
Interest expense |
|
|
|
|
|
|
(15 |
) |
|
|
|
|
|
|
|
Total other income |
|
|
527 |
|
|
|
350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(4,057 |
) |
|
$ |
(5,050 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS PER COMMON SHARE
(Basic and Diluted) |
|
$ |
(.03 |
) |
|
$ |
(.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
119,177 |
|
|
|
120,607 |
|
|
|
|
|
|
|
|
CONSOLIDATED BALANCE SHEET DATA:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2007 |
|
ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,439 |
|
|
$ |
24,300 |
|
Short-term investments |
|
|
14,886 |
|
|
|
|
|
Receivables, net |
|
|
78 |
|
|
|
71 |
|
Inventories |
|
|
8 |
|
|
|
8 |
|
Other current assets |
|
|
1,766 |
|
|
|
2,366 |
|
Property and equipment, net |
|
|
2,671 |
|
|
|
2,606 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
32,848 |
|
|
$ |
29,351 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
3,500 |
|
|
$ |
3,504 |
|
Shareholders equity |
|
|
28,251 |
|
|
|
24,858 |
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
32,848 |
|
|
$ |
29,351 |
|
|
|
|
|
|
|
|
# # #