Aastrom Biosciences, Inc.
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):
February 8, 2008
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 Identification |
incorporation)
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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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 February 8, 2008, we issued a press release announcing financial results and achievements for
our second fiscal quarter ended December 31, 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.
(d) 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 February 8, 2008 |
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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: February 8, 2008
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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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Exhibit 99.1
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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AASTROM REPORTS SECOND QUARTER FISCAL YEAR 2008
FINANCIAL RESULTS
Continued Clinical Progress Reported from Tissue Regeneration Programs
Ann Arbor, Michigan, February 8, 2008 Aastrom Biosciences, Inc. (Nasdaq: ASTM), a leading
regenerative medicine company, today reported financial results for the second fiscal quarter ended
December 31, 2007. The Company also reported several clinical achievements since the beginning of
the second fiscal quarter, including:
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First compassionate-use cardiac patient treatment with Aastroms autologous stem cell
therapy for dilated cardiomyopathy (DCM). The milestone marked the first human application
of the Companys Cardiac Repair Cell (CRC) product to regenerate damaged heart tissue in
patients with severely impaired cardiac function. The use of CRCs in patients is ongoing
and Aastrom anticipates that clinical data from the compassionate-use cases will be
available during 2008. |
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Interim and final clinical results in the vascular and bone programs: |
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Promising interim results were presented from the first 13 patients
treated in a multi-arm Phase I/II single-center clinical trial in Germany to
evaluate the safety of Vascular Repair Cells (VRCs), normal bone marrow cells and
the standard of care in the treatment of chronic diabetic foot wounds associated
with critical limb ischemia (CLI). Twelve months post-treatment, all 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. |
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Early clinical results were presented from the first use of Aastroms
Bone Repair Cells (BRCs) to treat four patients suffering from osteonecrosis of the
femoral head in Germany. All 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 work within six months after treatment. No
cell-related adverse events were observed and none of the patients have required
hip replacement surgery. |
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Final results of the Companys U.S. Phase I/II clinical trial designed
to collect safety and efficacy data utilizing BRCs in the treatment of severe
non-union fractures were reported. Of the 36 patients treated in the trial, 33
completed the 12-month follow-up. An overall 91% healing rate was observed after
12 months, including success in 91% (21 of 23) of tibia fractures, 100% (3 of 3) of
humerus fractures, and 86% (6 of 7) of femur fractures. All of the healed patients
are fully weight-bearing, have regained range of motion and are no longer impaired
by their injuries. |
We continue to report encouraging progress in all aspects of our clinical development programs.
The milestones we achieved since last quarter support our continuing efforts to advance our
regenerative medicine products through the regulatory process toward commercialization, said
George Dunbar, President and Chief Executive Officer of Aastrom. Aastrom has laid the foundation
for building shareholder value by addressing a range of unmet needs for patients who
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Aastrom Biosciences § Dominos Farms, Lobby K § 24 Frank Lloyd Wright Dr. § Ann Arbor, MI 48105 USA
Tel: 734-930-5555 § Fax: 734-665-0485 § mail@aastrom.com § www.aastrom.com
Aastrom-
2nd Q FY2008 Fin Results
February 8, 2008
Page 2
currently have limited or no treatment options. We look forward to reporting developments from our
cardiac and planned neural clinical activities as they occur.
Second Fiscal Quarter Ended December 31, 2007 Results
Total revenues for the quarter and six months ended December 31, 2007, consisting of grant revenue
and product sales, were $84,000 and $171,000, respectively, compared to $158,000 and $262,000 for
the same periods in fiscal year 2007.
Total costs and expenses for the quarter and six months ended December 31, 2007 increased to
$5,621,000 and $11,108,000, respectively, from $4,898,000 and $9,586,000 for the same periods 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, research and development expenses increased to $3,895,000 and $7,768,000, respectively, for
the quarter and six months ended December 31, 2007 compared to $2,563,000 and $4,867,000 for the
same periods in fiscal year 2007. Research and development expenses for the quarter and six months
ended December 31, 2007, included a non-cash charge of $214,000 and $437,000, respectively,
compared to $181,000 and $290,000 for the same periods in fiscal year 2007, relating to share-based
compensation expense.
Selling, general and administrative expenses decreased to $1,725,000 and $3,339,000, respectively,
for the quarter and six months ended December 31, 2007 from $2,332,000 and $4,716,000 for the same
periods in fiscal year 2007. For the quarter and six months ended December 31, 2007, selling,
general and administrative expenses included a non-cash charge of $344,000 and $670,000,
respectively, compared to $690,000 and $1,152,000 for the same periods in fiscal year 2007,
relating to share-based compensation expense.
Interest income for the quarter and six months ended December 31, 2007 decreased to $386,000 and
$751,000, respectively, from $515,000 and $1,042,000 for the same periods 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 $21,000 and $36,000, respectively, for the quarter and six months ended
December 31, 2007 related to long-term debt for equipment acquired during the fiscal year ended
June 30, 2007.
Net loss for the quarter ended December 31, 2007 was $5,172,000, or $.04 per share, compared to a
net loss of $4,225,000, or $.04 per share for the same period in fiscal year 2007. Net loss for
the six months ended December 31, 2007, was $10,222,000, or $.08 per share, compared to $8,282,000,
or $.07 per share for the same period in fiscal year 2007. The increases in net loss are 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 December 31, 2007, the Company had $31.2 million in cash, cash equivalents and short-term
investments as compared to $28.3 million at June 30, 2007. As clinical activities expand, it is
expected that the Companys cash utilization will average $1.8 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, Inc., will host a conference call to
review and discuss the second quarter fiscal year 2008 financial results at 9:00 a.m. (EST) today,
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Aastrom- 2nd Q FY2008 Fin Results
February 8, 2008
Page 3
February 8, 2008. 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=125365. 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 February 18, 2008, 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: 271471.
About Aastrom Biosciences, Inc.
Aastrom is a leading regenerative medicine company engaged 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 vascular, bone, 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 vascular regeneration product in clinical development for the treatment of
critical limb ischemia (called the RESTORE-CLI trial), a bone regeneration product in Phase III
development for the treatment of osteonecrosis of the femoral head (called the ON-CORE trial), a
cardiac regeneration product in clinical development for dilated cardiomyopathy and a preclinical
research program targeting unmet needs in 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, adequacy of existing capital to support operations
for a specified time, future capital needs, and potential advantages and application of Tissue
Repair Cell (TRC) Technology, all of which involve certain risks and uncertainties. These
statements are often, but are not always, made through the use of words or phrases such as
anticipates, estimates, plans, expects, management believes, we believe, we intend,
and similar words or phrases, or future or conditional verbs such as will, would, should,
could, may, or similar expressions. 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
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AASTROM BIOSCIENCES, INC.
(Unaudited)
(In thousands, except per share amounts)
CONSOLIDATED STATEMENTS OF OPERATIONS DATA:
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Quarter ended December 31, |
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Six months ended December 31, |
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2006 |
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2007 |
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2006 |
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2007 |
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REVENUES: |
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Total revenues |
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$ |
158 |
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$ |
84 |
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$ |
262 |
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$ |
171 |
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COSTS AND EXPENSES: |
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Cost of product sales |
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3 |
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1 |
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3 |
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1 |
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Research and development |
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2,563 |
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3,895 |
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4,867 |
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7,768 |
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Selling, general and administrative |
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2,332 |
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1,725 |
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4,716 |
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3,339 |
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Total costs and expenses |
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4,898 |
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5,621 |
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9,586 |
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11,108 |
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OTHER INCOME (EXPENSE): |
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Interest income |
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515 |
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386 |
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1,042 |
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751 |
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Interest expense |
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(21 |
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(36 |
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Total other income |
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515 |
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365 |
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1,042 |
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715 |
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NET LOSS |
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$ |
(4,225 |
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$ |
(5,172 |
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$ |
(8,282 |
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$ |
(10,222 |
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NET LOSS PER COMMON SHARE
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(Basic and Diluted) |
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$ |
(.04 |
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$ |
(.04 |
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$ |
(.07 |
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$ |
(.08 |
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Weighted average number of common shares
outstanding |
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119,516 |
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130,467 |
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119,347 |
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125,537 |
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CONSOLIDATED BALANCE SHEET DATA:
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June 30, |
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December 31, |
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2007 |
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2007 |
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ASSETS |
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Cash and cash equivalents |
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$ |
13,439 |
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$ |
16,259 |
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Short-term investments |
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14,886 |
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14,930 |
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Receivables, net |
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78 |
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107 |
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Inventories |
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8 |
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Other current assets |
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1,766 |
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2,135 |
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Property and equipment, net |
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2,671 |
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2,464 |
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Total assets |
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$ |
32,848 |
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$ |
35,895 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities |
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$ |
3,500 |
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$ |
2,156 |
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Long-tem debt |
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1,097 |
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1,011 |
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Shareholders equity |
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28,251 |
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32,728 |
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Total liabilities and shareholders equity |
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$ |
32,848 |
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$ |
35,895 |
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