e10vq
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED March 31, 2011,
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM _____ TO ______
Commission file number 0-22025
AASTROM BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Michigan
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94-3096597 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. employer
identification no.) |
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24 Frank Lloyd Wright Dr.
P.O. Box 376
Ann Arbor, Michigan
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48106 |
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(Address of principal executive offices)
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(Zip code) |
(734) 418-4400
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
(Do not check if a smaller reporting company)
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Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock as
of the latest practicable date.
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COMMON STOCK, NO PAR VALUE
(Class)
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38,620,850
Outstanding at April 29, 2011 |
AASTROM BIOSCIENCES, INC.
QUARTERLY REPORT ON FORM 10-Q
TABLE OF CONTENTS
2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, amounts in thousands)
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December 31, |
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March 31, |
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2010 |
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2011 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
31,248 |
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$ |
24,621 |
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Receivables, net |
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25 |
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18 |
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Other current assets |
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426 |
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439 |
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Total current assets |
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31,699 |
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25,078 |
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Property and equipment, net |
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1,128 |
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1,153 |
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Total assets |
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$ |
32,827 |
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$ |
26,231 |
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LIABILITIES AND SHAREHOLDERS EQUITY (DEFICIT) |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
2,900 |
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$ |
2,308 |
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Accrued employee benefits |
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796 |
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467 |
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Current portion of long-term debt |
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214 |
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159 |
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Warrant liabilities |
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25,954 |
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24,700 |
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Total current liabilities |
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29,864 |
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27,634 |
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Long-term debt |
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41 |
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43 |
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Shareholders equity (deficit): |
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Common stock, no par value; shares authorized 62,500
and 150,000, respectively; shares issued and outstanding
38,616 and 38,618, respectively. |
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225,102 |
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225,722 |
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Deficit accumulated during the development stage |
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(222,180 |
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(227,168 |
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Total shareholders equity (deficit) |
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2,922 |
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(1,446 |
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Total liabilities and shareholders equity (deficit) |
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$ |
32,827 |
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$ |
26,231 |
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The
accompanying Notes to Condensed Consolidated Financial Statements are an integral part of
these statements.
3
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, amounts in thousands except per share amounts)
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March 24, 1989 |
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Quarter ended |
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(Inception) to |
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March 31, |
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March 31, |
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2010 |
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2011 |
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2011 |
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Revenues: |
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Product sales and rentals |
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$ |
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$ |
9 |
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$ |
1,868 |
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Research and development agreements |
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2,105 |
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Grants |
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9,901 |
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Total revenues |
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9 |
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13,874 |
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Costs and expenses: |
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Cost of product sales and rentals |
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2 |
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3,039 |
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Research and development |
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2,845 |
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4,372 |
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173,747 |
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Selling, general and administrative |
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1,418 |
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1,895 |
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79,019 |
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Total costs and expenses |
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4,263 |
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6,269 |
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255,805 |
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Loss from operations |
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(4,263 |
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(6,260 |
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(241,931 |
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Other income (expense): |
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Decrease in fair value of warrants |
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1,559 |
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1,254 |
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4,214 |
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Other income |
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1,249 |
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Interest income |
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34 |
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20 |
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10,739 |
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Interest expense |
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(9 |
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(2 |
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(471 |
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Total other income |
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1,584 |
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1,272 |
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15,731 |
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Net loss |
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$ |
(2,679 |
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$ |
(4,988 |
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$ |
(226,200 |
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Net loss per share (Basic and Diluted) |
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$ |
(0.10 |
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$ |
(0.13 |
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Weighted average number of common shares
outstanding (Basic and Diluted) |
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26,737 |
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38,617 |
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The
accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
4
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, amounts in thousands)
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March 24, 1989 |
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Quarter ended |
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(Inception) to |
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March 31, |
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March 31, |
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2010 |
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2011 |
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2011 |
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Operating activities: |
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Net loss |
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$ |
(2,679 |
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$ |
(4,988 |
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$ |
(226,200 |
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Adjustments to reconcile net loss to net cash used for
operating activities: |
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Depreciation and amortization |
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153 |
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134 |
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6,985 |
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Loss on property held for resale |
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110 |
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Amortization of discounts and premiums on investments |
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(1,704 |
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Stock compensation expense |
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76 |
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616 |
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10,758 |
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Decrease in fair value of warrants |
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(1,559 |
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(1,254 |
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(4,214 |
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Inventory write downs and reserves |
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2,240 |
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Stock issued pursuant to license agreement |
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3,300 |
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Provision for losses on accounts receivable |
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204 |
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Changes in operating assets and liabilities: |
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Receivables |
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23 |
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7 |
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(267 |
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Inventories |
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(2,335 |
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Other current assets |
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(39 |
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(13 |
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(419 |
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Accounts payable and accrued expenses |
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(205 |
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(592 |
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2,076 |
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Accrued employee benefits |
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6 |
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(329 |
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467 |
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Net cash used for operating activities |
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(4,224 |
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(6,419 |
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(208,999 |
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Investing activities: |
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Organizational costs |
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(73 |
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Purchase of short-term investments |
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(5,000 |
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(217,041 |
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Maturities of short-term investments |
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218,745 |
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Property and equipment purchases |
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(47 |
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(148 |
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(6,334 |
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Proceeds from sale of property held for resale |
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400 |
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Net cash provided used for investing activities |
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(5,047 |
) |
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(148 |
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(4,303 |
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Financing activities: |
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Net proceeds from issuance of preferred stock |
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51,647 |
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Net proceeds from issuance of common stock and warrants |
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12,426 |
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4 |
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184,680 |
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Repurchase of common stock |
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(49 |
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Payments received for stock purchase rights |
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3,500 |
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Payments received under shareholder notes |
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31 |
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Restricted cash used as compensating balance |
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70 |
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Proceeds from long-term debt |
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751 |
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Principal payments under long-term debt obligations |
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(120 |
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(64 |
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(2,637 |
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Net cash provided by (used for) financing activities |
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12,376 |
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(60 |
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237,923 |
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Net increase (decrease) in cash and cash equivalents |
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3,105 |
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(6,627 |
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24,621 |
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Cash and cash equivalents at beginning of period |
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14,739 |
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31,248 |
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Cash and cash equivalents at end of period |
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$ |
17,844 |
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$ |
24,621 |
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$ |
24,621 |
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The
accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
5
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
1. Organization and Summary of Significant Accounting Policies
Aastrom Biosciences, Inc. was incorporated in March 1989 (Inception), began
employee-based operations in 1991, and is in the development stage. The Company operates its
business in one reportable segment research and product development involving the development of
patient specific cell therapies for use in severe, chronic cardiovascular diseases.
Successful future operations are subject to several technical hurdles and risk factors,
including satisfactory product development, timely initiation and completion of clinical trials,
regulatory approval and market acceptance of the Companys therapies and the Companys continued
ability to obtain future funding.
The Company is subject to certain risks related to the operation of its business and
development of its therapies.. The Company believes that it will have adequate liquidity to finance
its operations, including development of its products and product candidates, via its cash and
investments on hand as of March 31, 2011 until at least December 31, 2011. While the Companys
budgeted cash usage and operating plan for 2011 does not currently contemplate taking additional
actions to reduce the use of cash over the next twelve months, the Company could, if necessary,
delay or forego certain budgeted discretionary expenditures such as anticipated hiring plans or
certain non-critical research and development expenditures, as well as slow down or delay certain
clinical trial activity (without jeopardizing our Phase 3 clinical trial for CLI) such that the
Company will have sufficient cash on hand until at least December 31, 2011. On a longer-term basis,
the Company will need to raise additional funds in order to complete its product development
programs, complete clinical trials needed to market its products, and commercialize these products.
The Company cannot be certain that such funding will be available on favorable terms, if at all.
Some of the factors that will impact the Companys ability to raise additional capital and its
overall success include: the rate and degree of progress for its product development, the rate of
regulatory approval to proceed with clinical trial programs, the level of success achieved in
clinical trials, the requirements for marketing authorization from regulatory bodies in the United
States and other countries, the liquidity and market volatility of the Companys equity securities,
regulatory and manufacturing requirements and uncertainties, technological developments by
competitors, and other factors. If the Company cannot raise such funds, it may not be able to
develop or enhance products, take advantage of future opportunities, or respond to competitive
pressures or unanticipated requirements, which would likely have a material adverse impact on the
Companys business, financial condition and results of operations.
2. Basis of Presentation
The condensed consolidated financial statements included herein have been prepared in
accordance with the rules and regulations of the Securities and Exchange Commission (SEC). Certain
information and footnote disclosures normally included in financial statements prepared in
accordance with generally accepted accounting principles in the United States of America (U.S.
GAAP) have been omitted pursuant to such rules and regulations. The financial statements reflect,
in the opinion of management, all adjustments (consisting only of normal, recurring adjustments)
necessary to state fairly the financial position and results of operations as of and for the
periods indicated. The results of operations for the three months ended March 31, 2011, are not
necessarily indicative of the results to be expected for the full year or for any other period.
The December 31, 2010 condensed consolidated balance sheet data was derived from audited
consolidated financial statements, but does not include all disclosures required by U.S. GAAP.
These condensed consolidated financial statements should be read in conjunction with the
audited consolidated financial statements and the notes thereto included in our Transition Report
on Form 10-KT for the six month transition period ended December 31, 2010, as filed with the SEC.
The condensed consolidated financial statements include the accounts of Aastrom and its
wholly-owned subsidiaries, Aastrom Biosciences GmbH, located in Berlin, Germany, Aastrom
Biosciences Ltd., located in Dublin, Ireland, and Aastrom Biosciences, SL, located in Barcelona,
Spain, which was dissolved in December 2010. All inter-company transactions and accounts have been
eliminated in consolidation. The subsidiaries had limited operations and are not currently a
significant component of the consolidated financial statements.
6
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
On January 28, 2011, the Company received a comment letter from the staff of the SEC relating
to its Annual Report on Form 10-K for the fiscal year ended June 30, 2010. As a result, the
Company reassessed its accounting treatment for all warrants issued by the Company since 2000 and
determined that certain warrants did not appropriately consider the provisions of ASC 815-40
Derivatives and Hedging Contracts in Entitys Own Equity. The Company filed an Amended Annual
Report on Form 10-K/A for the fiscal year ended June 30, 2010 and amended quarterly filings on Form
10-Q/A for the quarters ended September 30, 2009, December 31, 2009, March 31, 2010 and September
30, 2010. All periods presented in each filing were restated to account for the warrants issued in
April 2004, October 2004, October 2007 and January 2010 (Class A warrants and Class B warrants) as
liabilities with changes in fair value in subsequent periods recorded as non-cash income or
expense. The Company used a Black-Scholes valuation methodology for all of these warrants.
The Company received a follow up comment letter from the SEC staff on March 29, 2011. As a
result, the Company reassessed the appropriateness of the Black-Scholes valuation methodology used
for the Class A warrants issued in January 2010 and the appropriateness of liability accounting for
the Class B warrants issued in January 2010 (which expired unexercised in July 2010). After
further analysis, the Company concluded that a Monte Carlo valuation methodology is more
appropriate for valuing the Class A warrants and the terms of the Class B warrants are such that
the Class B warrants should have been classified as equity rather than as a liability.
The Company assessed the aforementioned items and concluded the impacts to the Companys
previously-filed financial statements, including the March 31, 2010 Quarterly Report on Form 10-Q,
were not material. However, as of December 31, 2010, the Company began utilizing a Monte Carlo
valuation methodology to estimate the fair value of its Class A warrants. Additionally, the
Company corrected the cumulative impact of the aforementioned items in the six-month transition
period ended December 31, 2010. The impact of these items was not material to the quarter or
six-month transition period ended December 31, 2010. These corrections decreased the Companys net
loss for the six-month transition period ended December 31, 2010 by approximately $77,000 and also
decreased the Companys shareholders equity at December 31, 2010 by $349,000.
3. Fair Value Measurements
The Company measures certain assets and liabilities at fair value on a recurring basis.
Fair value represents the amount that would be received upon the sale of an asset or paid to
transfer a liability in an orderly transaction between market participants. As such, fair value is
determined based upon assumptions that market participants would use in pricing an asset or
liability. As a basis for considering such assumptions, a three-tier fair value hierarchy, which
prioritizes the inputs used in measuring fair value as follows:
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Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; |
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Level 2 inputs: Inputs, other than quoted prices included in Level 1 that are observable either
directly or indirectly; and |
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Level 3 inputs: Unobservable inputs for which there is little or no market data, which require
the reporting entity to develop its own assumptions. |
In many cases, a valuation technique used to measure fair value includes inputs from multiple
levels of the fair value hierarchy described above. The lowest level of significant input
determines the placement of the entire fair value measurement in the hierarchy.
At March 31, 2011, the Company had $24,377,000 invested in three money market funds with
maturities of three months or less that are included within the Cash and cash equivalents line on
the Condensed Consolidated Balance Sheet. Because there is an active market for shares in the
money market funds, the Company considers its fair value measures of these investments to be based
on Level 1 inputs. The valuation technique used to measure these assets is a market approach,
using prices and other relevant information generated by market transactions involving identical
assets.
7
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
See Note 5 for disclosures related to the fair value of the Companys warrants. The
Company does not have any other assets or liabilities on the balance sheet as of March 31, 2011
that are measured at fair value.
4. Stock-Based Compensation
The Company issues nonqualified and incentive stock options as well as other equity awards
pursuant to its 2009 Omnibus Incentive Plan, as amended (Option Plan). Such awards pursuant to the
Option Plan may be granted by the Companys Board of Directors to certain of the Companys
employees, directors and consultants.
During the quarter ended March 31, 2011, the Company granted 3,394,050 service-based options
to purchase common stock. These options were granted with exercise prices equal to the fair value
of the Companys stock at the grant date, vest over four years (other than 505,975 non-employee
director options which vest over three years) and have lives of ten years. The weighted average
grant-date fair value of service-based options granted under the Companys Option Plan during the
quarters ended March 31, 2010 and 2011 was $1.54 and $1.52, respectively.
The net compensation costs recorded for the service-based stock options related to employees
and directors (including the impact of forfeitures) were approximately $75,000 and $630,000 for the
quarters ended March 31, 2010 and 2011, respectively. The expense in March 2010 was impacted by a
$296,000 reversal of expense for forfeitures in excess of the Companys expected forfeiture rate.
The fair value of each service-based stock option grant for the reported periods is estimated
on the date of the grant using the Black-Scholes option-pricing model using the weighted average
assumptions noted in the following table.
|
|
|
|
|
|
|
|
|
|
|
Quarter ended March 31, |
|
Service-Based Stock Options |
|
2010 |
|
|
2011 |
|
Expected dividend rate |
|
0 % |
|
0 % |
Expected stock price volatility |
|
70.5% 72.3% |
|
74.0% 78.9% |
Risk-free interest rate |
|
2.8% 3.1% |
|
2.7% |
Estimated forfeiture rate (per annum) |
|
10% |
|
10% |
Expected life (years) |
|
6.0 6.3 |
|
6.0 6.3 |
The following table summarizes the activity for service-based stock options for the indicated
periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Contractual Term |
|
|
Aggregate Intrinsic |
|
Service-Based Stock Options |
|
Options |
|
|
Exercise Price |
|
|
(Years) |
|
|
Value |
|
Outstanding at December 31, 2010 |
|
|
4,297,209 |
|
|
$ |
2.43 |
|
|
|
8.9 |
|
|
$ |
3,158,978 |
|
Granted |
|
|
3,394,050 |
|
|
$ |
2.27 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(2,500 |
) |
|
$ |
1.80 |
|
|
|
|
|
|
$ |
2,225 |
|
Forfeited or expired |
|
|
(50,034 |
) |
|
$ |
3.96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2011 |
|
|
7,638,725 |
|
|
$ |
2.35 |
|
|
|
9.3 |
|
|
$ |
3,732,158 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March 31, 2011 |
|
|
1,131,011 |
|
|
$ |
4.31 |
|
|
|
7.4 |
|
|
$ |
342,470 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
As of March 31, 2011 there was approximately $6,029,000 of total unrecognized compensation
cost related to non-vested service-based stock options granted under the Option Plan. That cost is
expected to be recognized over a weighted-average period of 3.6 years.
The total fair value of options vested during the quarters ended March 31, 2010 and 2011 was
$285,000 and $376,000, respectively.
5. Stock Purchase Warrants
The Company has historically issued warrants to purchase shares of the Companys common
stock in connection with certain of its common stock offerings. The following warrants were
outstanding during the quarters ended March 31, 2010 and 2011, and include provisions that could
require cash settlement of the warrants or have anti-dilution price protection provisions requiring
each to be recorded as liabilities of the Company at the estimated fair value at the date of
issuance, with changes in estimated fair value recorded as non-cash income or expense in the
Companys statement of operations in each subsequent period:
|
(i) |
|
warrants to purchase an aggregate of 740,131 shares of the Companys common stock,
issued on October 17, 2007 in connection with the Companys registered direct offering,
exercisable from April 18, 2008 through April 17, 2013 at an exercise price of $12.72 per
share, all of which remained outstanding as of March 31, 2011; |
|
(ii) |
|
Class A warrants to purchase an aggregate of 4,882,228 shares of the Companys common
stock, issued on January 21, 2010 in connection with the Companys registered public
offering, exercisable for a five year period commencing on July 21, 2010 at an exercise
price of $2.52 per share (as adjusted from $2.97 per share for the anti-dilution provision
triggered in the December 2010 financing), 4,525,978 of which remained outstanding as of
March 31, 2011; and |
|
(iii) |
|
warrants to purchase an aggregate of 10,000,000 shares of the Companys common
stock, issued on December 15, 2010 in connection with the Companys registered public
offering, exercisable for a five year period commencing on December 15, 2010 at an
exercise price of $3.22 per share, all of which remained outstanding as of March 31, 2011. |
All of the warrants listed above could require net cash settlement in the event that
registered shares are not available at the time of exercise of such warrant. The Class A warrants
and the December 2010 warrants also contain anti-dilution provisions that adjust the exercise price
of the warrant if the Company issues or sells, or is deemed to have issued or sold, any shares of
its common stock or securities exercisable or convertible into shares of common stock for no
consideration or for a consideration per share less than the applicable exercise price in effect
immediately prior to the time of such issue or sale. In the event of such a subsequent issuance of
common stock of the Company, (i) the exercise price of the Class A warrants would be adjusted to a
point between the current exercise price per share of such Class A warrant and the price per share
at which the new shares of common stock of the Company are being issued based on a weighted average
calculation as outlined in the Class A warrant agreement, and (ii) the exercise price of the
December 2010 warrants would be adjusted to the price per share at which the new shares of common
stock of the Company are being issued. Notwithstanding the foregoing, there are certain issuances
of the Company that would not trigger the anti-dilution provisions of the Class A warrants or the
December 2010 warrants, including but not limited to, issuances under any duly authorized Company
stock option, restricted stock plan or stock purchase plan whether now existing or hereafter
approved by the Company and its stockholders in the future, or as an inducement grant to employees,
consultants, directors or officers. The December
2010 warrants also contain a feature that allows the warrant holder to put the warrants back
to the Company and receive cash in the event of a fundamental transaction, such as a change in
control of the Company or a sale of all or substantially all of its assets. The value received by
the warrant holder upon exercise of the put right is based on a Black-Scholes model using a defined
set of inputs outlined in the December 2010 warrant agreement.
9
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
The Class A warrants and the December 2010 warrants are measured using the Monte Carlo
valuation model, while the October 2007 warrants are measured using the Black-Scholes valuation
model. Both of the methodologies are based, in part, upon inputs for which there is little or no
observable market data, requiring the Company to develop its own assumptions. The assumptions used
in calculating the estimated fair value of the warrants represent the Companys best estimates,
however these estimates involve inherent uncertainties and the application of management judgment.
As a result, if factors change and different assumptions are used, the warrant liabilities and the
change in estimated fair value of the warrants could be materially different.
Inherent in both the Monte Carlo and Black-Scholes valuation models are assumptions related to
expected stock-price volatility, expected life, risk-free interest rate and dividend yield. The
Company estimates the volatility of its common stock based on historical volatility that matches
the expected remaining life of the warrants. The risk-free interest rate is based on the U.S.
Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected remaining
life of the warrants. The expected life of the warrants is assumed to be equivalent to their
remaining contractual term. The dividend rate is based on the historical rate, which the Company
anticipates to remain at zero.
The Monte Carlo model is used for the Class A warrants and the December 2010 warrants to value
the potential future exercise price adjustments triggered by the anti-dilution provisions as well
as the value of the put feature of the December 2010 warrants. These both require Level 3 inputs
which are based on the Companys estimates of the probability and timing of potential future
financings and fundamental transactions. The other assumptions used by the Company are summarized
in the following tables.
|
|
|
|
|
|
|
|
|
October 2007 Warrants |
|
December 31, 2010 |
|
|
March 31, 2011 |
|
Closing stock price |
|
$ |
2.56 |
|
|
$ |
2.50 |
|
Expected dividend rate |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
100.3 |
% |
|
|
83.7 |
% |
Risk-free interest rate |
|
|
0.6 |
% |
|
|
0.8 |
% |
Expected life (years) |
|
|
2.25 |
|
|
|
2.00 |
|
|
|
|
|
|
|
|
|
|
January 2010 Class A Warrants |
|
December 31, 2010 |
|
|
March 31, 2011 |
|
Closing stock price |
|
$ |
2.56 |
|
|
$ |
2.50 |
|
Expected dividend rate |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
79.6 |
% |
|
|
81.4 |
% |
Risk-free interest rate |
|
|
1.8 |
% |
|
|
2.0 |
% |
Expected life (years) |
|
|
4.56 |
|
|
|
4.31 |
|
|
|
|
|
|
|
|
|
|
December 2010 Warrants |
|
December 31, 2010 |
|
|
March 31, 2011 |
|
Closing stock price |
|
$ |
2.56 |
|
|
$ |
2.50 |
|
Expected dividend rate |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
78.0 |
% |
|
|
78.9 |
% |
Risk-free interest rate |
|
|
2.0 |
% |
|
|
2.1 |
% |
Expected life (years) |
|
|
4.96 |
|
|
|
4.71 |
|
The following table summarizes the change in the estimated fair value of the Companys warrant
liabilities (in thousands):
|
|
|
|
|
Warrant Liabilities |
|
|
|
|
Balance at December 31, 2010 |
|
$ |
25,954 |
|
Decrease in fair value |
|
|
(1,254 |
) |
|
|
|
|
Balance at March 31, 2011 |
|
$ |
24,700 |
|
|
|
|
|
10
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
6. Net Loss Per Common Share
Net loss per common share is computed using the weighted-average number of common shares
outstanding during the period. Common equivalent shares are not included in the diluted per share
calculation where the effect of their inclusion would be anti-dilutive. The aggregate number of
common equivalent shares (related to options and warrants) that have been excluded from the
computations of diluted net loss per common share for the periods ended March 31, 2010 and 2011
were approximately 11,215,000 and 24,941,000, respectively.
11
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations |
Overview
We are developing expanded patient specific mixed cellular therapies for use in the treatment
of severe, chronic ischemic cardiovascular diseases. Ixmyelocel-T (the new generic name for our
cell therapy approved in March 2011) is a disease modifying therapy with multi-functional
properties including: tissue remodeling, immuno-modulation and the promotion of angiogenesis, which
is targeted to address the multiple underlying causes of many severe, chronic cardiovascular
diseases such as critical limb ischemia (CLI). Our proprietary cell-manufacturing technology
enables the manufacture of cell therapies expanded from a patients own bone marrow and delivered
directly to damaged tissues. Preclinical and interim clinical data suggest that ixmyelocel-T may
be effective in treating patients with severe, chronic ischemic cardiovascular diseases such as
CLI. Preliminary data utilizing ixmyelocel-T in dilated cardiomyopathy (DCM) have also shown
safety as well as provided indications of efficacy. Nearly 200 patients have been treated in
recent clinical trials using ixmyelocel-T (over 400 patients safely treated since our inception)
with no treatment related serious adverse events.
Our Technology Platform
Our technology is a patient specific, expanded multi-functional cell therapy developed using
our proprietary, automated processing system to produce human cell products for clinical use. The
Aastrom process enhances bone marrow mononuclear cells by expanding the mesenchymal stromal cells
and alternatively activated macrophages while retaining many of the hematopoietic cells. The
manufacture of our expanded, patient specific cell therapies is done under current Good
Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) guidelines required by the
U.S. Food and Drug Administration (FDA).
Our
expanded, patient specific multi-functional cellular therapies have several features that
we believe are critical for success in treating patients with severe, chronic cardiovascular
diseases:
Safe our bone marrow-derived, expanded, patient specific cellular therapy leverages
decades of scientific and medical experience, as bone marrow and bone marrow-like therapies have
been used safely and efficaciously in medicine for over three decades.
Autologous (patient specific) we start with the patients own cells, which are accepted
by the patients immune system allowing the cells to differentiate and integrate into existing
functional tissues, and, we believe provides long-term engraftment and repair.
Expanded we begin with a small amount of bone marrow from a patient (approximately 50 ml)
and significantly expand the number of certain cell types, primarily CD90+ mesenchymal
cells, CD14+ monocytes and alternatively activated macrophages to far more than are
present in the patients own bone marrow (up to 300 times the number of these cells compared with
the starting bone marrow aspirate).
A mixture of cell types we believe our proprietary mixture of cell types, which are
normally found in bone marrow, but in different quantities, possess multiple activities required
for tissue remodeling, immuno-modulation and the promotion of angiogenesis.
Minimally invasive our procedure for taking bone marrow (an aspirate) can be performed
in an out-patient setting and takes approximately 15 minutes. For diseases such as CLI, the
administration of our therapy can be performed in an out-patient setting in a one-time,
approximately 20 minute procedure. We are also pursuing a minimally invasive approach to cell
delivery in other severe, chronic ischemic cardiovascular diseases such as DCM.
Our cell therapies are produced at our cell manufacturing facility in the United States,
located at our headquarters in Ann Arbor, Michigan.
12
Clinical Development Programs
Our clinical development programs are focused on advancing therapies for unmet medical needs
in severe, chronic ischemic cardiovascular diseases. We are currently completing our Phase 2b
clinical trial in CLI and we expect it to advance to a Phase 3 development program in 2011. Our
CLI development program has received Fast Track Designation from the FDA. Our DCM program is in
early Phase 2 clinical development and is focused on achieving proof of concept in this indication.
Our DCM development program has received Orphan Disease Designation from the FDA.
Results to date in our clinical trials may not be indicative of results obtained from
subsequent patients enrolled in those trials or from future clinical trials. Further, our future
clinical trials may not be successful or we may not be able to obtain the required Biologic License
Application (BLA) approval to commercialize our products in the United States in a timely fashion,
or at all. See Risk Factors in Item 1A of our Transition Report on Form 10-KT for the six month
period ended December 31, 2010.
Critical Limb Ischemia
Background
CLI is the most serious and advanced stage of peripheral arterial disease (PAD). PAD is a
chronic atherosclerotic disease that progressively restricts blood flow in the limbs and can lead
to serious medical complications. This disease is often associated with other clinical conditions
including hypertension, cardiovascular disease, hyperlipidemia, diabetes, obesity and stroke. CLI
is used to describe patients with the most severe forms of PAD: those with chronic ischemia-induced
pain (even at rest), ulcers, tissue loss or gangrene in the limbs, often leading to amputation and
death. CLI leads to more than 160,000 amputations per year. The one-year and four-year mortality
rates for no-option CLI patients that progress to amputation are approximately 25% and 70%,
respectively. Our disease modifying therapy with multi-functional properties has shown significant
promise in the treatment of CLI.
Clinical Programs
Our U.S. Phase 2b RESTORE-CLI program is a multi-center, randomized, double-blind, placebo
controlled clinical trial. This clinical trial is designed to evaluate the safety and efficacy of
ixmyelocel-T in the treatment of patients with CLI. It is the largest multi-center, randomized,
double-blind, placebo-controlled cellular therapy study ever conducted in CLI patients. We
completed enrollment of this trial in February 2010 with a total of 86 patients at 18 sites across
the United States, with the last patient being treated in March 2010. These patients are being
followed for a period of 12 months following treatment. In addition to assessing the safety of our
product, efficacy endpoints include amputation-free survival, time to first occurrence of treatment
failure (defined as major amputation, all-cause mortality, doubling in wound size and de novo
gangrene), major amputation rates, level of amputation, complete wound healing, patient quality of
life and pain scores.
Results to date include two planned interim analyses. In June 2010, we reported results at
the Society of Vascular Surgery Meeting. This interim analysis included the six month results for
46 patients enrolled in the trial. The results included the finding that amputation free survival,
defined as time to major amputation or death, was statistically significant in favor of our therapy
(p=0.038). Additionally, statistical analysis revealed a significant increase in time to treatment
failure (e.g., major amputation, doubling in wound size de novo gangrene, or death) (log-rank test,
p=0.0053). Other endpoints measured (e.g., major amputation rate, complete wound healing, change
in Wagner wound scale) showed encouraging trends, but had not reached statistical significance at
the interim analysis. The primary purpose of the interim analysis was to assess performance of our
therapy and, if positive, to help plan the Phase 3 program. In June 2010 we held discussions with
the FDA, which confirmed the appropriateness of using amputation free survival as a primary
endpoint for our planned Phase 3 program.
In November 2010, we presented six-month data on all patients enrolled in the trial at the
VEITHsymposium non-CME satellite session. Results of this analysis showed that the study achieved
both its primary safety endpoint and primary efficacy endpoint of time to first occurrence of
treatment failure. The findings related to time to first occurrence of treatment failure were
statistically significant (p=0.0132). Further analyses show a clinically meaningful reduction of
56% in treatment failure events. Analysis of the data for amputation-free survival, a
secondary endpoint which the study was not powered to demonstrate, showed a clinically
meaningful reduction in event rates of 24%, but did not show statistical significance (p=0.5541).
13
We continue to make progress towards the Phase 3 clinical development program in CLI. In
October 2010, we announced that the FDA had granted Fast Track Designation for the use of our
multi-functional cellular therapy for the CLI indication. The Fast Track program is designed to
facilitate the development and expedite the review of new drugs and biologics, intended to treat
serious or life-threatening conditions that demonstrate the potential to address unmet medical
needs. During June 2010 discussions with the FDA, Aastrom was encouraged to use the Special
Protocol Assessment (SPA) process for the Phase 3 program. In October 2010, we submitted two SPA
requests to the FDA, one for a no option patient population and another for a poor option
patient population. The no option SPA request focuses on patients that have exhausted all other
treatment options with the exception of amputation. The poor option SPA request focuses on
patients that have not yet exhausted all other treatment options; however the options available are
associated with poor outcomes. We expect to have the no option and poor option agreements on the
SPAs completed in the second and third quarter of 2011, respectively.
Dilated Cardiomyopathy
Background
DCM is a severe, chronic cardiovascular disease that leads to enlargement of the heart,
reducing the pumping function of the heart to the point that blood circulation is impaired.
Patients with DCM typically present with symptoms of congestive heart failure, including
limitations in physical activity and shortness of breath. There are two types of DCM: ischemic and
non-ischemic. Ischemic DCM, the most common form, is associated with atherosclerotic cardiovascular
disease. Among other causes, non-ischemic DCM can be triggered by toxin exposure, virus or genetic
diseases. Patient prognosis depends on the stage and cause of the disease but is typically
characterized by a high mortality rate. Other than heart transplantation or ventricular assist
devices, there are currently no effective treatment options for end-stage patients with this
disease. According to the book, Heart Failure: A Combined Medical and Surgical Approach (2007), DCM
affects 200,000-400,000 patients in the United States alone.
In February 2007, the FDA granted Orphan Drug Designation to our investigational therapy for
the treatment of DCM. Our DCM development program is currently in Phase 2 and we have two ongoing
U.S. Phase 2 trials investigating surgical and catheter-based delivery for our product in the
treatment of DCM.
Surgical Trial Program DCM
In May 2008, the FDA activated our investigational new drug application (IND) for surgical
delivery of our therapy. The 40-patient U.S. IMPACT-DCM clinical trial began with the treatment of
the first patient in November 2008. This multi-center, randomized, controlled, prospective,
open-label, Phase 2 study was designed to include 20 patients with ischemic DCM and 20 patients
with non-ischemic DCM. We completed enrollment of the 40 patients in the IMPACT-DCM clinical trial
in January 2010 and the final patient was treated in March 2010. Participants in the IMPACT-DCM
clinical trial were required to have New York Heart Association (NYHA) functional class III or IV
heart failure, a left ventricular ejection fraction (LVEF) of less than or equal to 30% (60-75% is
typical for a healthy person), and meet other eligibility criteria, including optimized medical
therapy. Patients were randomized in an approximate 3:1 ratio of treatment to control group.
Patients in the treatment group received our therapy through direct injection into the heart muscle
during minimally invasive-surgery (involving a chest incision of approximately 2 inches). The
primary objective of this study is to assess the safety of ixmyelocel-T in patients with DCM.
Efficacy measures include cardiac dimensions and tissue mass, cardiac function (e.g. cardiac
output, LVEF, cardiopulmonary exercise testing parameters), cardiac perfusion and viability, as
well as other efficacy endpoints. NYHA functional class and quality of life are also assessed.
Patients were followed for 12 months post-treatment.
Six-month data from the IMPACT-DCM interim analysis were presented at The Sixth International
Conference on Cell Therapy for Cardiovascular Disease on January 20, 2011. Results indicated that
ixmyelocel-T is safe and showed that serious adverse events were associated with the surgical
procedure and not the cellular therapy. Adverse events after the initial peri-operative period
were roughly equal between the control and treatment groups. Efficacy findings include positive
trends in quality of life and functional and structural parameters in the treatment
group as compared with the control group. We expect to report 12-month data from the
IMPACT-DCM clinical study in the third quarter of 2011.
14
Catheter Trial Program DCM
In November 2009, the FDA activated our second IND to allow for the evaluation of our therapy
delivered by a percutaneous direct catheter injection as opposed to surgically. The Catheter-DCM
clinical trial is designed to explore catheter-based delivery of ixmyelocel-T to treat DCM
patients. This multi-center, randomized, controlled, prospective, open-label, Phase 2 study
enrolled approximately 11 patients with ischemic DCM and 10 patients with non-ischemic DCM at
clinical sites across the United States. Participants met the same criteria as stated above for the
IMPACT-DCM surgical trial. The first patient was enrolled into the trial in April 2010 and
enrollment concluded in December 2010 with 21 patients enrolled. We expect to report six-month
results from the Catheter-DCM Phase 2 trial in the third quarter of 2011.
Results of Operations
Research and development expenses increased to $4,372,000 for the quarter ended March 31, 2011
from $2,845,000 for the quarter ended March 31, 2010 due to the
advanced preparation related to the Phase 3 clinical program for
ixmyelocel-T, including increased employee costs, clinical site
identification and set-up, as well as regulatory expenses. These amounts include non-cash stock-based compensation expense of $361,000 for the
quarter ended March 31, 2011, compared to a net expense reversal of $25,000 for the quarter ended
March 31, 2010. Stock-based compensation expense for the quarter ended March 31, 2010 included a
reversal of $171,000 for certain non-vested stock options forfeited in excess of the Companys
assumed forfeiture rate.
Our major ongoing research and development programs are focused on the clinical development of
ixmyelocel-T for treatment of severe, chronic cardiovascular diseases. The following table
summarizes the approximate allocation of cost for our research and development projects (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Quarter ended March 31, |
|
|
|
2010 |
|
|
2011 |
|
Critical Limb Ischemia |
|
$ |
1,175 |
|
|
$ |
2,353 |
|
Dilated Cardiomyopathy |
|
|
1,637 |
|
|
|
1,997 |
|
Other |
|
|
33 |
|
|
|
22 |
|
|
|
|
|
|
|
|
Total research and development expenses |
|
$ |
2,845 |
|
|
$ |
4,372 |
|
|
|
|
|
|
|
|
Selling, general and administrative expenses increased to $1,895,000 for the quarter ended
March 31, 2011 from $1,418,000 for the quarter ended
March 31, 2010 due to expenses associated with the previously
announced restatement of the companys historical financial
statements, as well as an increase in non-cash
stock-based compensation and consulting costs. Stock-based compensation included in selling,
general and administrative expenses increased to $255,000 for the quarter ended March 31, 2011 from
$100,000 for the quarter ended March 31, 2010. Stock based compensation expense for the quarter
ended March 31, 2010 included a reversal of $125,000 for certain non-vested stock options forfeited
in excess of the Companys assumed forfeiture rate.
Non-cash income from the change in fair value of warrants was $1,254,000 for the quarter ended
March 31, 2011 compared to $1,559,000 for the quarter ended March 31, 2010. The fluctuation is due
primarily to changes in the fair value of our common stock and the issuance of warrants in December
2010. Fluctuations in the fair value of warrants in future periods could result in significant
non-cash adjustments to the condensed consolidated financial statements, however any income or
expense recorded will not impact our cash and cash equivalents, operating expenses or cash flows.
Our net loss was $4,988,000, or $0.13 per share for the quarter ended March 31, 2011 compared
to $2,679,000, or $0.10 per share for the quarter ended March 31, 2010. The changes in net loss
are primarily due to the increase in research and development expenses, in addition to the increase
in selling, general and administrative expenses offset by the non-cash change in fair value of
warrants. Loss per share comparisons were also impacted by the issuance of 10,000,000 shares of
common stock in December 2010.
15
Liquidity and Capital Resources
We are currently focused on utilizing our technology to produce patient specific cell-based
therapies for use in severe chronic ischemic cardiovascular diseases. At such time as we satisfy
applicable regulatory approval requirements, we expect the sales of our cell-based therapies to
constitute nearly all of our product sales revenues.
We do not expect to generate positive cash flows from our consolidated operations for at least
the next several years and then only if we achieve significant product sales. Until that time, we
expect that our revenue sources from our current activities will consist of only minor sales of our
cell products and manufacturing supplies to our academic collaborators, grant revenue, research
funding and potential licensing fees or other financial support from potential future corporate
collaborators.
We expect that we will need to raise significant additional funds or pursue strategic
transactions or other strategic alternatives in order to complete our product development programs,
complete clinical trials needed to market our products, and commercialize our products. To date, we
have financed our operations primarily through public and private sales of our equity securities,
and we expect to continue to seek to obtain the required capital in a similar manner. As a
development stage company, we have never been profitable and do not anticipate having net income
unless and until significant product sales commence. With respect to our current activities, this
is not likely to occur until we obtain significant additional funding, complete the required
clinical trials for regulatory approvals, and receive the necessary approvals to market our
products. Through March 31, 2011, we had accumulated a net loss of approximately $226,200,000. We
cannot provide any assurance that we will be able to achieve profitability on a sustained basis, if
at all, obtain the required funding, obtain the required regulatory approvals, or complete
additional corporate partnering or acquisition transactions.
We have financed our operations since inception primarily through public and private sales of
our equity securities, and, to a lesser degree, through grant funding, payments received under
research agreements and collaborations, interest earned on cash, cash equivalents, and short-term
investments, stock option and warrant exercises and funding under equipment leasing agreements.
These financing sources have generally allowed us to maintain adequate levels of cash and other
liquid investments.
Our cash and cash equivalents totaled $24,621,000 at March 31, 2011, a decrease of $6,627,000
from December 31, 2010. During the quarter ended March 31, 2011, the primary uses of cash and cash
equivalents included $6,419,000 for our operations and working capital requirements, and $148,000
in capital expenditures. Our cash and cash equivalents included money market securities with
maturities of three months or less.
Our future cash requirements will depend on many factors, including continued scientific
progress in our research and development programs, the scope and results of clinical trials, the
time and costs involved in obtaining regulatory approvals, the costs involved in filing,
prosecuting and enforcing patents, competing technological and market developments, costs of
possible acquisition or development of complementary business activities and the cost of product
commercialization. We do not expect to generate positive cash flows from operations for at least
the next several years due to the expected spending for research and development programs and the
cost of commercializing our product candidates. We intend to seek additional funding through
research and development agreements or grants, distribution and marketing agreements and through
public or private debt or equity financing transactions. Successful future operations are subject
to several technical and risk factors, including our continued ability to obtain future funding,
satisfactory product development, obtaining regulatory approval and market acceptance for our
products.
In order to complete our Phase 3 CLI trial, grow and expand our business, introduce our
product candidates into the marketplace and possibly acquire or develop complementary business
activities, we will need to raise additional funds. We will also need additional funds or a
collaborative partner, or both, to finance the research and development activities of our product
candidates for the expansion of additional cell types. We expect that our primary sources of
capital for the foreseeable future will be through collaborative arrangements and through the
public or private sale of our equity or debt securities. There can be no assurance that such
collaborative arrangements, or any public or private financing, will be available on acceptable
terms, if at all, or can be sustained. Several factors will affect our ability to raise additional
funding, including, but not limited to, market volatility of
our common stock, continued stock market listing and economic conditions affecting the public
markets generally or some portion or the entire technology sector.
16
We believe that we will have adequate liquidity to finance our operations, including
development of our products and product candidates, via our cash and cash equivalents on hand as of
March 31, 2011 until at least December 31, 2011. While our budgeted cash usage and operating plan
for 2011 does not currently contemplate taking additional actions to reduce the use of cash over
the next twelve months, we could, if necessary, delay or forego certain budgeted discretionary
expenditures such as anticipated hiring plans or certain non-critical research and development
expenditures. In addition, we could slow down or delay certain clinical trial activity (without
jeopardizing our Phase 3 clinical trial for CLI) such that we will have sufficient cash on hand
until at least December 31, 2011. These estimates are based on certain assumptions which could be
negatively impacted by the matters discussed under this heading and under the caption Risk
Factors, in Item 1A of our Transition Report on Form 10-KT for the six month period ended December
31, 2010 filed with the SEC.
Off-Balance Sheet Arrangements
At March 31, 2011, we were not party to any off-balance sheet arrangements.
Forward-Looking Statements
This report, including the documents that we incorporate by reference, contains
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). Any statements
about our expectations, beliefs, plans, objectives, assumptions or future events or performance are
not historical facts and may be forward-looking. These statements are often, but are not always,
made through the use of words or phrases such as anticipates, estimates, plans, projects,
trends, opportunity, comfortable, current, intention, position, assume, potential,
outlook, remain, continue, maintain, sustain, seek, achieve, continuing, ongoing,
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.
Accordingly, these statements involve estimates, assumptions and uncertainties which could cause
actual results to differ materially from those expressed in them. The factors described in Part I,
Item 1A, Risk Factors, in our Transition Report on Form 10-KT for the six months ended December
31, 2010, among others, could have a material adverse effect upon our business, results of
operations and financial conditions.
Because the factors referred to in the preceding paragraph could cause actual results or
outcomes to differ materially from those expressed in any forward-looking statements we make, you
should not place undue reliance on any such forward-looking statements. Further, any
forward-looking statement speaks only as of the date on which it is made, and we undertake no
obligation to update any forward-looking statement or statements to reflect events or circumstances
after the date on which such statement is made or to reflect the occurrence of unanticipated
events. New factors emerge from time to time, and it is not possible for us to predict which
factors will arise. In addition, we cannot assess the impact of each factor on our business or the
extent to which any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements. These forward-looking
statements include statements regarding:
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potential strategic collaborations with others; |
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future capital needs and financing sources; |
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adequacy of existing capital to support operations for a specified time; |
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product development and marketing plan; |
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features and successes of our cellular therapies; |
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manufacturing and facility capabilities; |
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clinical trial plans and anticipated results; |
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anticipation of future losses; |
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commercialization plans; and |
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revenue expectations and operating results. |
17
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not Applicable.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31,
2011. The term disclosure controls and procedures is defined in Rules 13a-15(e) and 15d-15(e)
under the Exchange Act. Management recognizes that any disclosure controls and procedures no matter
how well designed and operated, can only provide reasonable assurance of achieving their objectives
and management necessarily applies its judgment in evaluating the cost-benefit relationship of
possible controls and procedures.
Based on their evaluation, our management, including our Chief Executive Office and Chief
Financial Officer, concluded that our disclosure controls and procedures were not effective to
provide reasonable assurance as of March 31, 2011 because of a material weakness in our internal
control over financial reporting described below.
Material Weakness
A material weakness is a deficiency, or a combination of deficiencies, in internal control
over financial reporting, such that there is a reasonable possibility that a material misstatement
of the Companys annual or interim financial statements will not be prevented or detected on a
timely basis. Based on this assessment using the COSO criteria, management has concluded that we
did not maintain effective internal control over financial reporting as of March 31, 2011, because
of a material weakness relating to accounting for warrants. Specifically, we did not maintain
effective controls over the identification and proper accounting treatment of certain terms and
conditions in our warrant agreements. This material weakness resulted in a misstatement of our
liabilities, non-cash expense relating to the changes in fair value of common stock warrants and
accumulated deficit accounts and related financial disclosures and the restatement of our
consolidated financial statements for the years ended June 30, 2010, 2009 and 2008, the period from
Inception to June 30, 2010, and each of the quarterly periods (including the period from Inception)
from September 30, 2008 through September 30, 2010 as discussed in Note 2 to the consolidated
financial statements included in our amended Annual Report on Form 10-K/A for the year ended June
30, 2010, and adjustments to the quarter and six month transition period ended December 31, 2010,
as discussed in Note 1 in the consolidated financial statements in our Transition Report on Form
10-KT for the six month period ended December 31, 2010. Additionally, this deficiency could result
in misstatements of the aforementioned accounts and disclosures that would result in a material
misstatement of the consolidated financial statements that would not be prevented or detected.
Remediation Plan
Management has been actively engaged in developing and implementing a remediation plan to
address the material weakness. Implementation of the remediation plan has occurred and consisted
of the combination of (i) hiring of new accounting/finance personnel and (ii) those personnel
revisiting the original accounting assessment for each of their historical warrants and assessing
the original accounting and the on-going accounting impact.
Management believes the foregoing efforts will effectively remediate the material weakness. As
the Company continues to evaluate and work to improve its internal control over financial
reporting, management may execute additional measures to address potential control deficiencies or
modify the remediation steps described above. Management will continue to review and make necessary
changes to the overall design of the Companys internal control.
Changes in Internal Control Over Financial Reporting
There have been no changes in the Companys internal control over financial reporting during
the quarter ended March 31, 2011 that have materially affected, or are reasonably likely to
materially affect, the Companys internal control over financial reporting.
18
PART II OTHER INFORMATION
Item 1. Legal Proceedings
From time to time we receive threats or may be subject to litigation matters incidental to our
business. However, we are not currently a party to any material pending legal proceedings.
Item 1A. Risk Factors
Information regarding risk factors of the Company is set forth in Item 1A, Risk Factors in
the Companys Transition Report on Form 10-K for the six month period ended December 31, 2010.
There have been no material changes in our risk factors from those disclosed in the Companys
Transition Report on Form 10-KT for the six month period ended December 31, 2010.
Item 4. Removed and Reserved
Item 6. Exhibits
The Exhibits listed in the Exhibit Index immediately following the Signature, are filed as a
part of this Quarterly Report on Form 10-Q.
19
SIGNATURE
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, thereunto duly authorized.
Date: May 16, 2011
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AASTROM BIOSCIENCES, INC.
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/s/ Timothy M. Mayleben
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Timothy M. Mayleben |
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President and Chief Executive Officer
(Principal Executive Officer) |
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/s/ Scott C. Durbin
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Scott C. Durbin |
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Chief Financial Officer
(Principal Financial and Accounting Officer) |
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20
EXHIBIT INDEX
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Exhibit No. |
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Description |
10.1#
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Employment Agreement with Ronnda L. Bartel dated March 22, 2011, attached as Exhibit
10.1 to Aastroms Current Report on Form 8-K filed on March 25, 2011, incorporated herein by
reference. |
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10.2#
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Employment Agreement with Sharon Watling, dated March 22, 2011, attached as Exhibit 10.2 to
Aastroms Current Report on Form 8-K filed on March 25, 2011, incorporated herein by
reference. |
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10.3#
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Senior Executive Incentive Bonus Plan, attached as Exhibit 10.3 to Aastroms Current Report
on Form 8-K filed on March 25, 2011, incorporated herein by reference. |
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10.4#
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Amendment to the 2009 Omnibus Incentive Plan, dated March 21, 2011, attached as exhibit 10.4
to Aastroms Current Report on Form 8-K filed on March 25, 2011, incorporated herein by
reference. |
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31.1
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Certification by Chief Executive Officer required by Rule 13a-14(a) or 15d-14(a) of the
Securities Exchange Act of 1934 (furnished herewith). |
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31.2
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Certification by Chief Financial Officer required by Rule 13a-14(a) or 15d-14(a) of the
Securities Exchange Act of 1934 (furnished herewith). |
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32.1
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Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (furnished herewith). |
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# |
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Management contract or compensatory plan or arrangement covering executive officers or
directors of Aastrom. |
21
GLOSSARY
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TERM |
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DEFINITION |
Adverse Event
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Any adverse change in health or
side-effect that occurs in a
person participating in a
clinical trial, from the time
they consent to joining the
trial until a pre-specified
period of time after their
treatment has been completed. |
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BLA Biologics License Application
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An application containing
product safety, efficacy and
manufacturing information
required by the FDA to market
biologics products in the U.S. |
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Catheter-DCM
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Aastroms U.S. Phase 2 clinical
trial investigating
catheter-based delivery of our
product in the treatment of
dilated cardiomyopathy. |
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CLI Critical Limb Ischemia
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An atherosclerotic vascular
disease characterized by
insufficient blood flow in the
lower extremities that causes
severe pain, tissue loss or
both. |
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Controlled Clinical Trial
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A clinical study that compares
patients receiving a specific
treatment to patients receiving
an alternate treatment for the
condition of interest. The
alternate treatment may be
another active treatment,
standard of care for the
condition and/or a placebo
(inactive) treatment. |
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DCM Dilated Cardiomyopathy
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A chronic cardiac disease where
expansion of the patients
heart reduces the pumping
function to a point that the
normal circulation of blood
cannot be maintained. |
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Double-Blind Clinical Trial
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Clinical trials in which
neither the patient nor the
physician know if the patient
received the experimental
treatment or a control/placebo. |
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FDA Food & Drug Administration
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The U.S. FDA ensures that
medicines, medical devices, and
radiation-emitting consumer
products are safe and
effective. Authorized by
Congress to enforce the Federal
Food, Drug, and Cosmetic Act
and several other public health
laws, the agency monitors the
manufacture, import, transport,
storage, and sale of $1
trillion worth of goods
annually. |
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GMP Good Manufacturing Practice
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GMP regulations require that
manufacturers, processors, and
packagers of drugs, medical
devices, some food, and blood
take proactive steps to ensure
that their products are safe,
pure, and effective. GMP
regulations require a quality
approach to manufacturing,
enabling companies to minimize
or eliminate instances of
contamination, mix-ups, and
errors. |
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IMPACT-DCM
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Aastroms U.S. Phase 2 clinical
trial investigating surgical
delivery of our product in the
treatment of dilated
cardiomyopathy. |
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IND Investigational New Drug
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An application submitted to the
FDA for a new drug or biologic
that, if allowed, will be used
in a clinical trial. |
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Ischemia
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A shortage or inadequate flow
of blood to a body part
(commonly an organ or tissue)
caused by a constriction or
obstruction of the blood
vessels supplying it. |
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LVEF Left Ventricular Ejection Fraction
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The fraction of blood pumped
out of the left ventricle with
each heart beat. |
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Open-label Clinical Trial
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A trial in which both the
treating physician and the
patient know whether they are
receiving the experimental
treatment or control/placebo
treatment. |
22
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TERM |
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DEFINITION |
Orphan Drug Designation
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Orphan drug refers to a drug
or biologic that is intended
for use in the treatment of a
rare disease or condition.
Orphan drug designation from
the U.S. Food and Drug
Association (FDA) qualifies the
sponsor to receive certain
benefits from the Government in
exchange for developing the
drug for a rare disease or
condition. The drug must then
go through the FDA marketing
approval process like any other
drug or biologic which
evaluates for safety and
efficacy. Usually a sponsor
receives a quicker review time
and lower application fees for
an orphan product. |
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Patient Specific (Autologous)
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Originating from the patient
receiving treatment. (Aastrom
uses only patient specific
cells) |
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Phase 1 Clinical Trial
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A Phase 1 trial represents an
initial study in a small group
of patients to test for safety
and other relevant factors. |
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Phase 2 Clinical Trial
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A Phase 2 trial represents a
study in a moderate number of
patients to assess the safety
and efficacy of a product. |
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Phase 2b Clinical Trial
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A Phase 2b trial is a
moderately-sized Phase 2 trial
that is more specifically
designed assess the efficacy of
a product than a Phase 2a
trial. |
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Phase 3 Clinical Trial
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Phase 3 studies are initiated
to establish safety and
efficacy in an expanded patient
population at multiple clinical
trial sites and are generally
larger than trials in earlier
phases of development. |
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Prospective Clinical Trial
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A clinical trial in which
participants are identified and
then followed throughout the
study going forward in time. |
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Randomized Clinical Trial
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A clinical trial in which the
participants are assigned
randomly to different treatment
groups. |
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23
exv31w1
EXHIBIT 31.1
CERTIFICATION
I, Timothy M. Mayleben, certify that:
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1. |
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I have reviewed this Quarterly Report on Form 10-Q of Aastrom Biosciences, Inc.; |
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2. |
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Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
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3. |
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Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this report; |
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4. |
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The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
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(a) Designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us
by others within those entities, particularly during the period in which this report is
being prepared; |
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(b) Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
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(c) Evaluated the effectiveness of the registrants disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on
such evaluation; and |
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(d) Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting. |
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5. |
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The registrants other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the registrants
auditors and the audit committee of the registrants board of directors (or persons
performing the equivalent functions): |
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(a) All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely
affect the registrants ability to record, process, summarize and report financial
information; and |
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(b) Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
Date: May 16, 2011
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/s/ Timothy M. Mayleben
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Timothy M. Mayleben |
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President and Chief Executive Officer
(Principal Executive Officer) |
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exv31w2
EXHIBIT 31.2
CERTIFICATION
I, Scott C. Durbin, certify that:
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1. |
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I have reviewed this Quarterly Report on Form 10-Q of Aastrom Biosciences, Inc.; |
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2. |
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Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
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3. |
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Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this report; |
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4. |
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The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
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(a) Designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us
by others within those entities, particularly during the period in which this report is
being prepared; |
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(b) Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
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(c) Evaluated the effectiveness of the registrants disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on
such evaluation; and |
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(d) Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting. |
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5. |
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The registrants other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the registrants
auditors and the audit committee of the registrants board of directors (or persons
performing the equivalent functions): |
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(a) All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely
affect the registrants ability to record, process, summarize and report financial
information; and |
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(b) Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
Date: May 16, 2011
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/s/ Scott C. Durbin
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Scott C. Durbin |
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Chief Financial Officer
(Principal Financial and Accounting Officer) |
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exv32w1
EXHIBIT 32.1
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Aastrom Biosciences, Inc. (the Company) on Form
10-Q for the quarter ended March 31, 2011, as filed with the Securities and Exchange
Commission on the date hereof (the Report), each of the undersigned officers of the
Company certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (Section 906), the following:
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(1) |
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The Report fully complies with the requirements of section 13(a) and 15(d) of the
Securities Exchange Act of 1934; and |
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(2) |
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The information contained in the Report fairly presents, in all material respects,
the financial condition and results of operations of the Company. |
Date: May 16, 2011
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/s/ Timothy M. Mayleben
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Timothy M. Mayleben |
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President and Chief Executive Officer
(Principal Executive Officer) |
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/s/ Scott C. Durbin
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Scott C. Durbin |
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Chief Financial Officer
(Principal Financial and Accounting Officer) |
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A signed original of this written statement required by Section 906 has been provided to Aastrom
Biosciences, Inc. and will be retained by Aastrom Biosciences, Inc. and furnished to the Securities
and Exchange Commission or its staff upon request.