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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 7, 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
incorporation)
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(Commission File No.)
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(I.R.S. Employer Identification
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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)) |
Item 2.02 Results of Operations and Financial Condition.
On November 7, 2008, we issued a press release announcing financial results and achievements
for our first fiscal quarter of the year ending June 30, 2009. 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 |
99.1
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Press Release dated November 7, 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: November 12, 2008
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AASTROM BIOSCIENCES, INC.
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By: |
/s/ George W. Dunbar, Jr.
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George W. Dunbar, Jr. |
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Chief Executive Officer and President |
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exv99w1
Exhibit 99.1
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FOR IMMEDIATE RELEASE |
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CONTACTS:
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Kris M. Maly or Kimberli OMeara
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Kevin McGrath |
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Investor Relations
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Cameron & Associates (Investors) |
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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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Stephen Zoegall |
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Berry & Company (Media) |
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Phone: (212) 253-8881 |
AASTROM BIOSCIENCES REPORTS FIRST QUARTER
FISCAL YEAR 2009 FINANCIAL RESULTS
Focus on Cardiovascular Regeneration Sets Foundation for Future Clinical Progress
Ann Arbor, Michigan, November 7, 2008 Aastrom Biosciences, Inc. (Nasdaq: ASTM), a leading
regenerative medicine company, today reported financial results for the first fiscal quarter ended
September 30, 2008. The Company also reported several recent clinical and operational
achievements, including:
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U.S. Phase II cardiac regeneration clinical trial opens first two clinical sites |
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The Methodist Hospital in Houston, TX and Baylor University Medical Center in Dallas, TX are
open for patient enrollment in the U.S. Phase II IMPACT-DCM clinical trial evaluating
Aastroms Cardiac Repair Cells (CRCs) in the treatment of dilated cardiomyopathy (DCM), a
disease associated with severe chronic heart failure. Three other clinical sites are
completing the steps necessary to prepare for patient enrollment. It is anticipated that
the first patient will be treated during the 4th quarter of calendar year 2008.
Aastroms protocol to initiate the 40-patient, randomized, controlled, prospective,
open-label IMPACT-DCM clinical trial, previously approved by the U.S. Food and Drug
Administration (FDA), seeks to enroll 20 patients with ischemic DCM and 20 patients with
non-ischemic DCM at five clinical sites in the U.S. |
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U.S. Phase IIb vascular regeneration clinical trial treats 30th patient |
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The 30th patient was treated in the U.S. Phase IIb RESTORE-CLI clinical trial.
This milestone marks an important step toward interim data retrieval from this clinical
trial evaluating Aastroms Vascular Repair Cells (VRCs) in the treatment of patients
suffering from the most severe form of peripheral arterial disease (PAD), critical limb
ischemia (CLI). After the 30th patient has been followed for one year, the
Company will be able to unblind and analyze the interim data. After analysis, the next
milestone for this trial will be reporting interim data from this first set of critically
ill patients. |
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$15 million common stock purchase program in place with Fusion Capital Fund II, LLC |
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Aastrom executed a $15 million common stock purchase program with Fusion Capital Fund II,
LLC (Fusion Capital) on October 27, 2008. Once the registration statement covering the
resale of shares being sold to Fusion Capital has been declared effective by the Securities
and Exchange Commission, Aastrom has the right, over a 25-month period, to sell shares of
common stock to Fusion Capital from time to time in amounts between $60,000 and $2 million,
up to an aggregate of $15 million, when the Company chooses to do so. |
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
-more-
Aastrom-1st Q FY2009 Fin Results
November 7, 2008
Page 2
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NASDAQ compliance period extended to March 20, 2009 |
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The Listings Qualifications Department of The Nasdaq Stock Market LLC (NASDAQ) notified
Aastrom on October 22, 2008 that, given the current extraordinary market conditions, NASDAQ
had suspended enforcement of the rules requiring a minimum $1.00 per share closing bid price
through Friday, January 16, 2009. The Company had previously been given until December 15,
2008 to evidence a closing bid price of $1.00 or more for a minimum of ten consecutive
business days to regain compliance. As a result of NASDAQs suspension, Aastrom now has
until March 20, 2009 to regain compliance with the $1.00 minimum closing bid price rule. |
Weve set a strong foundation to support and move our cardiovascular clinical programs forward.
Over 30 patients have been treated in our vascular regeneration trial and patients are actively
being recruited into our cardiac regeneration trial. Reprioritizing our clinical development
programs to focus on our cardiovascular applications, together with related staff reductions, has
significantly reduced our cash burn rate. Knowing that we will need additional capital to support
our programs, we recently initiated a common stock purchase program with Fusion Capital that allows
us to generate additional capital, said George Dunbar, President and Chief Executive Officer of
Aastrom. We are committed to achieving our clinical milestones and furthering our regenerative
medicine programs, and we look forward to reporting future clinical developments as they occur.
First Fiscal Quarter Ended September 30, 2008 Results
Total revenues for the quarter ended September 30, 2008, consisting of minimal product sales
including manufacturing supplies to academic collaborators in the U.S. and cell-based products to
EU physicians, were $27,000, compared to total revenues of $87,000 for the same period in fiscal
year 2008. Total revenues for the quarter ended September 30, 2007 also included grant funding of
$75,000.
Total costs and expenses decreased to $4,046,000 for the quarter ended September 30, 2008, from
$5,487,000 for the same period in fiscal year 2008.
Research and development expenses decreased to $2,726,000 for the quarter ended September 30, 2008
from $3,873,000 for the same period in fiscal year 2008. This decrease reflects the changes we
implemented in May 2008, when we reprioritized our clinical development programs to focus primarily
on cardiovascular applications. The reprioritization reduced our overall research and development
expenses, including salaries and benefits. Research and development expenses for the quarters
ended September 30, 2008 and 2007 also include a non-cash charge of $162,000 and $224,000,
respectively, relating to share-based compensation expense.
Selling, general and administrative expenses decreased to $1,316,000 for the quarter ended
September 30, 2008 from $1,614,000 for the same period in fiscal year 2008. This decrease is
primarily due to lower salaries and benefits that resulted from the reduction in staff that was
part of our clinical program reprioritization. Selling, general and administrative expenses for
the quarters ended September 30, 2008 and 2007 also include a non-cash charge of $201,000 and
$326,000, respectively, relating to share-based compensation expense.
Interest income was $127,000 for the quarter ended September 30, 2008 compared to $365,000 for the
same period in fiscal year 2008. 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.
Interest expense was $21,000 for the quarter ended September 30, 2008 compared to $15,000 for the
same period in fiscal year 2008. The interest expense is related to long-term debt for equipment
acquired during the fiscal year ended June 30, 2008.
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Aastrom-1st Q FY2009 Fin Results
November 7, 2008
Page 3
Net loss for the quarter ended September 30, 2008 was $3,913,000, or $.03 per common share compared
to $5,050,000, or $.04 per common share for the same period in fiscal year 2008. The decrease in
net loss is primarily the result of decreased 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, 2008, the Company had $18.7 million in cash, cash equivalents and short-term
investments as compared to $22.5 million at June 30, 2008. Subsequently, on October 27, 2008, the
Company entered into a common stock purchase program to sell shares of common stock to Fusion
Capital from time to time in amounts between $60,000 and $2 million, up to an aggregate of $15
million. The Company reduced costs and expenses in an attempt to achieve an estimated average cash
utilization of approximately $1.2 million per month for the fiscal year ending June 30, 2009,
through a combination of development and clinical program reprioritizations and adjustments
focusing on our cardiac regeneration program, along with reductions in overhead and staff.
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. 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. Ongoing
development activities are focused on applying TRC technology to cardiac and vascular tissue
regeneration. The Company is currently focused on cardiovascular regeneration and is conducting a
Phase II clinical trial with dilated cardiomyopathy (DCM) patients (the IMPACT-DCM trial) and a
Phase IIb clinical trial with critical limb ischemia (CLI) patients (the RESTORE-CLI trial).
This document contains forward-looking statements, including without limitation, statements
concerning clinical trial strategies, potential partnering activities, product development
objectives, potential advantages of TRC technology and TRC-based products, and potential product
applications, which involve certain risks and uncertainties. The forward-looking statements are
also identified through use of the words intends, expect, expected, should, anticipated,
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
clinical trial results, potential product development difficulties, the effects of competitive
therapies, regulatory approval requirements, the availability of financial and other 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 STATEMENT OF OPERATIONS DATA:
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Quarter ended September 30, |
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2007 |
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2008 |
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REVENUES: |
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Product sales |
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$ |
12 |
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$ |
27 |
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Grants |
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75 |
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Total revenues |
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87 |
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27 |
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COSTS AND EXPENSES: |
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Cost of product sales |
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4 |
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Research and development |
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3,873 |
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2,726 |
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Selling, general and administrative |
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1,614 |
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1,316 |
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Total costs and expenses |
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5,487 |
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4,046 |
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OTHER INCOME (EXPENSE): |
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Interest income |
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365 |
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127 |
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Interest expense |
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(15 |
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(21 |
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Total other income, net |
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350 |
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106 |
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NET LOSS |
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$ |
(5,050 |
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$ |
(3,913 |
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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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$ |
(.03 |
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Weighted average number of common shares outstanding |
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120,607 |
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132,796 |
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CONSOLIDATED BALANCE SHEET DATA:
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June 30, |
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September 30, |
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2008 |
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2008 |
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ASSETS |
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Cash and cash equivalents |
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$ |
16,492 |
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$ |
18,700 |
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Short-term investments |
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5,970 |
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Receivables, net |
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18 |
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66 |
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Other current assets |
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1,583 |
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1,581 |
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Property and equipment, net |
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2,154 |
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1,983 |
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Total assets |
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$ |
26,217 |
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$ |
22,330 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities |
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$ |
2,100 |
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$ |
1,874 |
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Long-term debt |
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783 |
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667 |
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Shareholders equity |
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23,334 |
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19,789 |
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Total liabilities and shareholders equity |
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$ |
26,217 |
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$ |
22,330 |
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