e10vqza
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q/A
Amendment No. 2
(Mark One)
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þ |
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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, 2010,
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) 930-5555
(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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28,255,889
Outstanding at May 4, 2010 |
Explanatory Note
We are filing this Amendment No. 2 (Amendment No. 2) to our Quarterly Report on Form 10-Q/A
for the quarter ended March 31, 2010, which was filed with the Securities and Exchange Commission
(SEC) on May 10, 2010 (the Original Filing), as amended by Amendment No. 1 on Form 10-Q/A filed
with the SEC on May 13, 2010 (Amendment No.1) to (amend and restate our unaudited consolidated
condensed financial statements and related disclosures for the nine months March 31, 2009 and March
31, 2010, and the period from inception to March 31, 2010, as discussed below and in Note 3 to the
accompanying restated consolidated condensed financial statements, as well as to amend certain
other Items within Amendment No. 1 as listed in Items Amended in this Filing below, as a result
of the restatement of our consolidated condensed financial statements.
Background of Restatement
On February 11, 2011, in connection with responding to certain comments raised by the Staff of
the SEC in its periodic review of our SEC filings, the Company in consultation with its Audit
Committee, concluded that its previously issued consolidated financial statements for all periods
included in our annual report on Form 10-K for the fiscal year ended June 30, 2010 and included in
our quarterly reports on Form 10-Q for the quarters ended September 30, 2009 through September 30,
2010 (collectively, the Affected Periods) should be restated because of a misapplication in the
guidance around accounting for Warrants (as defined below) and should no longer be relied upon.
However, the non-cash adjustments to the consolidated financial statements, in all of the Affected
Periods, do not impact the amounts previously reported for the Companys cash and cash equivalents,
operating expenses or cash flows.
The warrants at issue (collectively, the Warrants) include:
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(i) |
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warrants to purchase an aggregate of 300,000 shares of the Companys common
stock, issued in April 2004 at an exercise price of $13.20 per share; |
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(ii) |
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warrants to purchase an aggregate of 320,248 shares of the Companys common
stock, issued in October 2004 at an exercise price of $13.92 per share; |
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(iii) |
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warrants to purchase an aggregate of 740,131 shares of the Companys common
stock, issued in October 2007 at an exercise price of $12.72 per share; |
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(iv) |
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Class A warrants to purchase an aggregate of 4,882,228 shares of the Companys
common stock, issued in January 2010 at an exercise price of $2.97 per share; and |
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(v) |
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Class B warrants to purchase an aggregate of 3,254,818 shares of the Companys
common stock, issued in January 2010 at an exercise price of $2.08 per share. |
Historically, the Warrants were reflected as a component of equity as opposed to liabilities
on the balance sheets and the statements of operations did not include the subsequent non-cash
changes in estimated fair value of the Warrants in accordance with Accounting Standards
Codification 815, Derivatives and Hedging (ASC 815). The Warrants generally provide that, in the
event the related registration statement is not available for the issuance of the Warrant shares,
the holder may exercise the Warrant on a cashless basis (i.e., applying a portion of the Warrant
shares to the payment of the exercise price). In addition, the Class A warrants and Class B
warrants listed above provide the holder with weighted-average anti-dilution price protection in
the event we issue securities at a price per share that is less than the exercise price of the
warrants.
However, under the guidance of ASC 815, warrant instruments that could potentially require net
cash settlement in the absence of express language precluding such settlement, and, additionally,
warrants that provide for anti-dilution price protection, should be initially classified as
derivative liabilities at their estimated fair values, regardless of the likelihood that such
instruments will ever be settled in cash. In periods subsequent to issuance, changes in the
estimated fair value of the derivative instruments should be reported in the statement of
operations. Our Audit Committee, together with management, determined that the financial
statements in the Affected Periods should be restated to reflect the Warrants as liabilities, with
subsequent changes in their estimated fair value recorded as non-cash income or expense in each
Affected Period.
The cumulative effect of these adjustments on our financial statements is a 4.4% decrease in
the deficit accumulated during the development stage in the amount of $9.1 million as of March 31,
2010. These adjustments do not impact the amounts previously reported for the Companys cash and
cash equivalents, operating cash flows or operating expenses in any of the Affected Periods. An
explanation of the impact on our financial statements is contained in Note 3 to the consolidated
condensed financial statements contained in Part I Item 1 of this Amendment No. 2.
2
Restatement of Other Financial Statements
Along with the filing of this Amendment No. 2, we are concurrently filing amendments to our
Annual Report on Form 10-K for the fiscal year ended June 30, 2010 and Quarterly Reports on Form
10-Q for the quarters ended September 30, 2009, December 31, 2009, and September 30, 2010. The
amendments to our Quarterly Reports on Form 10-Q are being filed to restate our unaudited
consolidated condensed financial statements and related financial information for the periods
contained in those reports and to amend certain other Items within the previously-issued quarterly
filings, including Item 4 Controls and Procedures to reflect a reassessment of our disclosure
controls and procedures, and internal control over financial reporting. There is no impact on the
amounts previously reported for the Companys cash and cash equivalents, operating cash flows or
operating expenses in any of the Affected Periods as a result of the restatement. The cumulative
adjustment to shareholders equity as of the beginning of the nine months ended March 31, 2010 was
to reduce previously reported shareholders equity at that time by $0.5 million.
Internal Control Considerations
Our management determined that there was a control deficiency in its internal control that
constitutes a material weakness, as discussed in Part I Item 4 of this Amendment No. 2. A
material weakness is a deficiency, or combination of control deficiencies, in internal control over
financial reporting, such that there is a reasonable possibility that a material misstatement of
the annual or interim consolidated financial statements will not be prevented or detected on a
timely basis. For a discussion of managements consideration of the Companys disclosure controls
and procedures and the material weakness identified, see Part I Item 4 included in this Amendment
No. 2.
Items Amended in This Filing
For the convenience of the reader, this Amendment No. 2 sets forth the Original Filing, as
modified and superseded where necessary to reflect the restatement. The following items have been
amended as a result of, and to reflect, the restatement:
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Part I Item 1. Financial Statements; |
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Part I Item 2. Managements Discussion and Analysis of Financial Condition and
Results of Operations; and |
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Part I Item 4. Controls and Procedures. |
In accordance with applicable SEC rules, this Amendment No. 2 includes new certifications
required by Rule 13a-14 under the Securities and Exchange Act of 1934 (Exchange Act) from our
Chief Executive Officer and Chief Financial Officer dated as of the date of filing of this
Amendment No. 2.
Except for the items noted above, no other information included in the Original Filing, as
amended by Amendment No. 1, is being amended or updated by this Amendment No. 2. This Amendment No.
2 continues to describe the conditions as of the date of the Original Filing, as amended by
Amendment No. 1, and, except as contained herein, we have not updated or modified the disclosures
contained in the Original Filing, as amended by Amendment No. 1. Accordingly, this Amendment No. 2
should be read in conjunction with our filings made with the SEC subsequent to the filing of the
Original Filing, including any amendment to those filings.
3
AASTROM BIOSCIENCES, INC.
Quarterly Report on Form 10-Q/A
March 31, 2010
TABLE OF CONTENTS
4
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
CONSOLIDATED CONDENSED BALANCE SHEETS
(Unaudited)
(In thousands, except share amounts)
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June 30, |
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March 31, |
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2009 |
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2010 |
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(Restated) |
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(Restated) |
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Assets |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
17,000 |
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$ |
17,844 |
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Short-term investments |
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5,000 |
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Receivables, net |
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58 |
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Inventory |
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1 |
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Other current assets |
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732 |
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591 |
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Total current assets |
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17,791 |
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23,435 |
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PROPERTY AND EQUIPMENT, NET |
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1,485 |
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1,134 |
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Total assets |
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$ |
19,276 |
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$ |
24,569 |
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Liabilities and Shareholders Equity |
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CURRENT LIABILITIES: |
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Accounts payable and accrued expenses |
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$ |
853 |
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$ |
1,161 |
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Accrued employee benefits |
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355 |
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358 |
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Current portion of long-term debt |
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479 |
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291 |
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Warrant liabilities |
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532 |
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4,358 |
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Total current liabilities |
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2,219 |
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6,168 |
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LONG-TERM DEBT |
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305 |
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137 |
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SHAREHOLDERS EQUITY: |
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Common stock, no par value; shares authorized
31,250,000 and 62,500,000, respectively;
shares issued and outstanding 20,027,830 and
28,255,889, respectively |
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205,286 |
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217,589 |
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Deficit accumulated during the development stage |
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(188,534 |
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(199,325 |
) |
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Total shareholders equity |
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16,752 |
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18,264 |
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Total liabilities and shareholders equity |
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$ |
19,276 |
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$ |
24,569 |
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The accompanying notes are an integral part of these financial statements.
5
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share amounts)
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March 24, 1989 |
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Quarter ended |
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Nine months ended |
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(Inception) to |
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March 31, |
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March 31, |
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March 31, |
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2009 |
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2010 |
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2009 |
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2010 |
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2010 |
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(Restated) |
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(Restated) |
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(Restated) |
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(Restated) |
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(Restated) |
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REVENUES: |
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Product sales and rentals |
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$ |
58 |
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$ |
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$ |
113 |
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$ |
89 |
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$ |
1,850 |
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Research and development agreements |
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2,105 |
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Grants |
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9,657 |
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Total revenues |
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58 |
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113 |
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89 |
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13,612 |
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COSTS AND EXPENSES: |
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Cost of product sales and rentals |
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25 |
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47 |
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34 |
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796 |
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Cost of product sales and rentals
provision for obsolete and excess inventory |
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2,239 |
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Research and development |
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2,785 |
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2,845 |
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8,340 |
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9,039 |
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157,147 |
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Selling, general and administrative |
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1,260 |
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1,418 |
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3,909 |
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3,680 |
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72,338 |
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Total costs and expenses |
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4,070 |
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4,263 |
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12,296 |
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12,753 |
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232,520 |
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LOSS FROM OPERATIONS |
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(4,012 |
) |
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(4,263 |
) |
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(12,183 |
) |
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(12,664 |
) |
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(218,908 |
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OTHER INCOME (EXPENSE): |
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(Increase) decrease in fair value of warrants |
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481 |
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1,559 |
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(61 |
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1,823 |
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9,112 |
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Other income |
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1,249 |
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Interest income |
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57 |
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34 |
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253 |
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83 |
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10,647 |
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Interest expense |
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(17 |
) |
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(9 |
) |
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(58 |
) |
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(33 |
) |
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(457 |
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Other income |
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521 |
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1,584 |
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134 |
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1,873 |
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20,551 |
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NET LOSS |
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$ |
(3,491 |
) |
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$ |
(2,679 |
) |
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$ |
(12,049 |
) |
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$ |
(10,791 |
) |
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$ |
(198,357 |
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COMPUTATION OF NET LOSS PER SHARE APPLICABLE TO
COMMON SHARES: |
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NET LOSS |
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$ |
(3,491 |
) |
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$ |
(2,679 |
) |
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$ |
(12,049 |
) |
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$ |
(10,791 |
) |
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NET LOSS PER SHARE (Basic and Diluted) |
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$ |
(0.19 |
) |
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$ |
(0.10 |
) |
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$ |
(0.70 |
) |
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$ |
(0.47 |
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Weighted average number of shares outstanding
(Basic and Diluted) |
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18,327 |
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26,737 |
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17,242 |
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23,016 |
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The accompanying notes are an integral part of these financial statements.
6
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
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March 24, 1989 |
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Nine months ended |
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(Inception) to |
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March 31, |
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March 31, |
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2009 |
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2010 |
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2010 |
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(Restated) |
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(Restated) |
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(Restated) |
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OPERATING ACTIVITIES: |
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Net loss |
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$ |
(12,049 |
) |
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$ |
(10,791 |
) |
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$ |
(198,357 |
) |
Adjustments to reconcile net loss to net cash used for
operating activities: Depreciation and amortization |
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522 |
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454 |
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6,454 |
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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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(30 |
) |
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(1,704 |
) |
Stock compensation expense |
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1,129 |
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426 |
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8,815 |
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Increase (decrease) in fair value of warrants |
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61 |
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(1,823 |
) |
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(9,112 |
) |
Inventory write downs and reserves |
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2,239 |
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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 assets and liabilities: |
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Receivables |
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(236 |
) |
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58 |
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(249 |
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Inventories |
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1 |
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(2,335 |
) |
Other current assets |
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432 |
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(66 |
) |
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(500 |
) |
Accounts payable and accrued expenses |
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(23 |
) |
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|
308 |
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1,104 |
|
Accrued employee benefits |
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(392 |
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3 |
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358 |
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Net cash used for operating activities |
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(10,586 |
) |
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(11,430 |
) |
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(189,673 |
) |
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INVESTING ACTIVITIES: |
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|
|
Organizational costs |
|
|
|
|
|
|
|
|
|
|
(73 |
) |
Purchase of short-term investments |
|
|
|
|
|
|
(5,000 |
) |
|
|
(217,041 |
) |
Maturities of short-term investments |
|
|
6,000 |
|
|
|
|
|
|
|
213,745 |
|
Property and equipment purchases |
|
|
(34 |
) |
|
|
(103 |
) |
|
|
(5,864 |
) |
Proceeds from sale of property held for resale |
|
|
|
|
|
|
|
|
|
|
400 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used for) investing activities |
|
|
5,966 |
|
|
|
(5,103 |
) |
|
|
(8,833 |
) |
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of preferred stock |
|
|
|
|
|
|
|
|
|
|
51,647 |
|
Net proceeds from issuance of common stock and warrants |
|
|
7,343 |
|
|
|
17,526 |
|
|
|
162,871 |
|
Repurchase of common stock |
|
|
|
|
|
|
|
|
|
|
(49 |
) |
Payments received for stock purchase rights |
|
|
|
|
|
|
|
|
|
|
3,500 |
|
Payments received under shareholder notes |
|
|
|
|
|
|
|
|
|
|
31 |
|
Restricted cash used as compensating balance |
|
|
192 |
|
|
|
207 |
|
|
|
(70 |
) |
Proceeds from long-term debt |
|
|
|
|
|
|
|
|
|
|
751 |
|
Principal payments under long-term obligations |
|
|
(331 |
) |
|
|
(356 |
) |
|
|
(2,331 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
7,204 |
|
|
|
17,377 |
|
|
|
216,350 |
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
2,584 |
|
|
|
844 |
|
|
|
17,844 |
|
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD |
|
|
16,492 |
|
|
|
17,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT END OF PERIOD |
|
$ |
19,076 |
|
|
$ |
17,844 |
|
|
$ |
17,844 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
7
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
1. Organization
Aastrom Biosciences, Inc. (the Company or Aastrom) 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 focused on
innovative therapies to repair or regenerate damaged or diseased tissues or organs. Aastrom is
developing autologous cellular therapies for the treatment of 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 products 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 products and product candidates. While management believes available cash, cash
equivalents and short-term investments are adequate to finance its operations at least through
March 31, 2011, in part due to the fact that many of the Companys expenditures are discretionary
in nature and could, if necessary, be delayed, the Company will need to raise a substantial amount
of 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 of 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 U.S., E.U. 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 consolidated condensed financial statements included herein have been prepared by us
without audit according to 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 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 nine months ended March 31, 2010, are not
necessarily indicative of the results to be expected for the full year or for any other period.
These financial statements should be read in conjunction with the audited restated financial
statements and the notes thereto included in our Amendment No. 1 to Annual Report on Form 10-K/A
for the year ended June 30, 2010, that is being concurrently filed with the SEC.
The consolidated financial statements include the accounts of the Company and its wholly-owned
subsidiaries, Aastrom Biosciences GmbH, located in Berlin, Germany, Aastrom Biosciences, Ltd.,
located in Dublin, Ireland and Aastrom Biosciences, S.L., located in Barcelona, Spain
(collectively, the Company). All significant inter-company transactions and accounts have been
eliminated in consolidation. These subsidiaries have limited operations and are not significant to
the consolidated financial statements.
On February 18, 2010, the Companys board of directors by unanimous written consent authorized
a one for eight reverse split. Accordingly, all references to numbers of common stock and per share
data in the accompanying financial statements have been adjusted to reflect the reverse stock split
on a retroactive basis.
8
3. Restatement of Consolidated Financial Statements
Background
On February 11, 2011, in connection with responding to certain comments raised by the Staff of
the SEC in its periodic review of the Companys SEC filings, the Company in consultation with its
Audit Committee, concluded that its previously issued financial statements for all periods included
in the Companys annual report on Form 10-K for the fiscal year ended June 30, 2010 and included in
the Companys quarterly reports on Form 10-Q for the quarters ended September 30, 2009 through
September 30, 2010 (collectively, the Affected Periods) should be restated because of a
misapplication in the guidance around accounting for Warrants (as defined below) and should no
longer be relied upon. However, the non-cash adjustments to the financial statements, in all of
the Affected Periods, do not impact the amounts previously reported for the Companys cash and cash
equivalents, operating expenses or cash flows.
The warrants at issue (collectively, the Warrants) include:
|
(i) |
|
warrants to purchase an aggregate of 300,000 shares of the Companys common
stock, issued in April 2004 at an exercise price of $13.20 per share; |
|
(ii) |
|
warrants to purchase an aggregate of 320,248 shares of the Companys common
stock, issued in October 2004 at an exercise price of $13.92 per share; |
|
(iii) |
|
warrants to purchase an aggregate of 740,131 shares of the Companys common
stock, issued in October 2007 at an exercise price of $12.72 per share; |
|
(iv) |
|
Class A warrants to purchase an aggregate of 4,882,228 shares of the Companys
common stock, issued in January 2010 at an exercise price of $2.97 per share; and |
|
(v) |
|
Class B warrants to purchase an aggregate of 3,254,818 shares of the Companys
common stock, issued in January 2010 at an exercise price of $2.08 per share. |
Historically, the Warrants were reflected as a component of equity as opposed to liabilities
on the balance sheets and the statement of operations did not include the subsequent non-cash
changes in estimated fair value of the Warrants in accordance with Accounting Standards
Codification 815, Derivatives and Hedging (ASC 815). The Warrants generally provide that, in the
event the related registration statement is not available for the issuance of the Warrant shares,
the holder may exercise the Warrant on a cashless basis (i.e., applying a portion of the Warrant
shares to the payment of the exercise price). In addition, the Class A warrants and Class B
warrants listed above provide the holder with weighted-average anti-dilution price protection in
the event we issue securities at a price per share that is less than the exercise price of the
warrants.
However, under the guidance of ASC 815, warrant instruments that could potentially require net
cash settlement in the absence of express language precluding such settlement, and, additionally,
warrants that provide for anti-dilution price protection, should be initially classified as
derivative liabilities at their estimated fair values, regardless of the likelihood that such
instruments will ever be settled in cash. In periods subsequent to issuance, changes in the
estimated fair value of the derivative instruments should be reported in the statement of
operations. The Audit Committee, together with management, determined that the financial
statements in the Affected Periods should be restated to reflect the Warrants as liabilities, with
subsequent changes in their estimated fair value recorded as non-cash income or expense in each
Affected Period.
Impact of the Restatement
The cumulative effect of these adjustments on the Companys previously-reported deficit
accumulated during the development stage and total shareholders equity was a decrease of $7.4
million and $0.4 million, respectively, as of the beginning of the nine month period ended March
31, 2009. These adjustments do not impact the amounts previously reported for the Companys cash
and cash equivalents, net cash used for operating activities or operating expenses in any of the
Affected Periods.
9
The effects of the restatement on the following financial statement line items as of and for
the periods indicated are summarized in the following tables (in thousands except per share
amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Condensed Balance Sheets |
|
|
|
As Previously |
|
|
|
|
Reported |
|
|
Adjustments |
|
|
As Restated |
|
As of June 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liabilities |
|
$ |
|
|
|
$ |
532 |
|
|
$ |
532 |
|
Total current liabilities |
|
$ |
1,687 |
|
|
$ |
532 |
|
|
$ |
2,219 |
|
Common stock |
|
$ |
213,107 |
|
|
$ |
(7,821 |
) |
|
$ |
205,286 |
|
Deficit accumulated during the
development stage |
|
$ |
(195,823 |
) |
|
$ |
7,289 |
|
|
$ |
(188,534 |
) |
Total shareholders equity |
|
$ |
17,284 |
|
|
$ |
(532 |
) |
|
$ |
16,752 |
|
As of March 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liabilities |
|
$ |
|
|
|
$ |
4,358 |
|
|
$ |
4,358 |
|
Total current liabilities |
|
$ |
1,810 |
|
|
$ |
4,358 |
|
|
$ |
6,168 |
|
Common stock |
|
$ |
231,059 |
|
|
$ |
(13,470 |
) |
|
$ |
217,589 |
|
Deficit accumulated during the
development stage |
|
$ |
(208,437 |
) |
|
$ |
9,112 |
|
|
$ |
(199,325 |
) |
Total shareholders equity |
|
$ |
22,622 |
|
|
$ |
(4,358 |
) |
|
$ |
18,264 |
|
|
|
|
Consolidated Condensed Statements of Operations |
|
|
|
As Previously |
|
|
|
|
Reported |
|
|
Adjustments |
|
|
As Restated |
|
For the quarter ended March 31, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in fair value
of warrants |
|
$ |
|
|
|
$ |
481 |
|
|
$ |
481 |
|
Total other income |
|
$ |
40 |
|
|
$ |
481 |
|
|
$ |
521 |
|
Net loss |
|
$ |
(3,972 |
) |
|
$ |
481 |
|
|
$ |
(3,491 |
) |
Net loss per share (basic and diluted) |
|
$ |
(0.22 |
) |
|
$ |
0.03 |
|
|
$ |
(0.19 |
) |
For the nine months ended March 31, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in fair value
of warrants |
|
$ |
|
|
|
$ |
(61 |
) |
|
$ |
(61 |
) |
Total other income |
|
$ |
195 |
|
|
$ |
(61 |
) |
|
$ |
134 |
|
Net loss |
|
$ |
(11,988 |
) |
|
$ |
(61 |
) |
|
$ |
(12,049 |
) |
Net loss per share (basic and diluted) |
|
$ |
(0.70 |
) |
|
$ |
|
|
|
$ |
(0.70 |
) |
For the quarter ended March 31, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in fair value
of warrants |
|
$ |
|
|
|
$ |
1,559 |
|
|
$ |
1,559 |
|
Total other income |
|
$ |
25 |
|
|
$ |
1,559 |
|
|
$ |
1,584 |
|
Net loss |
|
$ |
(4,238 |
) |
|
$ |
1,559 |
|
|
$ |
(2,679 |
) |
Net loss per share (basic and diluted) |
|
$ |
(0.16 |
) |
|
$ |
0.06 |
|
|
$ |
(0.10 |
) |
For the nine months ended March 31, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in fair value
of warrants |
|
$ |
|
|
|
$ |
1,823 |
|
|
$ |
1,823 |
|
Total other income |
|
$ |
50 |
|
|
$ |
1,823 |
|
|
$ |
1,873 |
|
Net loss |
|
$ |
(12,614 |
) |
|
$ |
1,823 |
|
|
$ |
(10,791 |
) |
Net loss per share (basic and diluted) |
|
$ |
(0.55 |
) |
|
$ |
0.08 |
|
|
$ |
(0.47 |
) |
March 24, 1989 (Inception) to March 31, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in fair value
of warrants |
|
$ |
|
|
|
$ |
9,112 |
|
|
$ |
9,112 |
|
Total other income |
|
$ |
11,439 |
|
|
$ |
9,112 |
|
|
$ |
20,551 |
|
Net loss |
|
$ |
(207,469 |
) |
|
$ |
9,112 |
|
|
$ |
(198,357 |
) |
|
|
|
Consolidated Condensed Statements of Cash Flows |
|
|
|
As Previously |
|
|
|
|
Reported |
|
|
Adjustments |
|
|
As Restated |
|
For the nine months ended March 31, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(11,988 |
) |
|
$ |
(61 |
) |
|
$ |
(12,049 |
) |
Increase (decrease) in fair value
of warrants |
|
$ |
|
|
|
$ |
61 |
|
|
$ |
61 |
|
For the nine months ended March 31, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(12,614 |
) |
|
$ |
1,823 |
|
|
$ |
(10,791 |
) |
Increase (decrease) in fair value
of warrants |
|
$ |
|
|
|
$ |
(1,823 |
) |
|
$ |
(1,823 |
) |
March 24, 1989 (Inception) to March 31, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(207,469 |
) |
|
$ |
9,112 |
|
|
$ |
(198,357 |
) |
Increase (decrease) in fair value
of warrants |
|
$ |
|
|
|
$ |
(9,112 |
) |
|
$ |
(9,112 |
) |
10
4. Share-Based Compensation
The Company has various stock incentive plans and agreements (Option Plans) that provide for
the issuance of nonqualified and incentive stock options as well as other equity awards. Such
awards may be granted by the Companys Board of Directors to certain of the Companys employees,
directors and consultants.
Service-Based Options
During the nine months ended March 31, 2010, the Company granted 1,268,525 service-based
options to purchase common stock. These options were granted with exercise prices equal to the
closing price of the Companys stock on the grant date, vest over four years (other than
non-employee director options which vest over one to three years) and expire ten years from the
grant date. The weighted average grant-date fair value of service-based options granted under the
Companys Option Plans during the nine months ended March 31, 2009 and 2010 was $2.08 and $1.54,
respectively.
The net compensation costs recorded for the service-based stock options related to employees
and directors were approximately $75,000 and $415,000 for the quarter and nine months ended March
31, 2010, respectively, compared to $352,000 and $1,060,000 for the corresponding periods in fiscal
year 2009.
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 assumptions noted
in the following table.
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2010 |
|
Stock Option Plans: |
|
|
|
|
|
|
|
|
Expected dividend rate |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
73 |
% |
|
|
70.2% - 72.8 |
% |
Risk free interest rate |
|
|
2.1 |
% |
|
|
2.49% - 3.09 |
% |
Estimated forfeiture rate |
|
|
10 |
% |
|
|
10 |
% |
Expected life (years) |
|
|
6.6 |
|
|
|
5.5 - 6.25 |
|
The following table summarizes the activity for service-based stock options for the indicated
periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Remaining |
|
|
Aggregate Intrinsic |
|
|
|
Options |
|
|
Exercise Price |
|
|
Contractual Term |
|
|
Value |
|
Outstanding at June 30, 2009 |
|
|
1,365,353 |
|
|
$ |
7.76 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,268,525 |
|
|
$ |
2.33 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(355,931 |
) |
|
$ |
9.58 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2010 |
|
|
2,277,947 |
|
|
$ |
4.45 |
|
|
|
8.4 |
|
|
$ |
58,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March 31, 2010 |
|
|
715,046 |
|
|
$ |
7.88 |
|
|
|
6.5 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2010, there was approximately $1,391,000 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 1.7 years.
11
Performance-Based Stock Options
There were no grants of performance-based stock options during the nine months ended March 31,
2010. There have been no changes to the terms of the performance-based stock options from those
disclosed in our Annual Report on Form 10-K for the year ended June 30, 2009.
For the nine months ended March 31, 2010, management reviewed the progress toward the
performance conditions necessary for these options to vest and concluded that it was not yet
probable that the performance conditions of any of the tranches of options would be met and,
accordingly, no compensation expense has been recorded.
The following table summarizes the activity for performance-based stock options for the
indicated period:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Remaining |
|
|
Aggregate Intrinsic |
|
Options |
|
Shares |
|
|
Exercise Price |
|
|
Contractual Term |
|
|
Value |
|
Outstanding at June 30, 2009 |
|
|
110,162 |
|
|
$ |
11.76 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(49,999 |
) |
|
$ |
11.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2009 |
|
|
60,163 |
|
|
$ |
12.19 |
|
|
|
6.6 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate estimated fair value of these awards that are outstanding as of March 31, 2010
is approximately $493,000.
Restricted Stock Awards
Restricted stock awards generally vest over a four year period and entitle the recipient to
receive common stock upon vesting. The compensation costs charged as operating expenses for
restricted stock were approximately $1,000 and $11,000 for the quarter and nine months ended March
31, 2010, respectively, compared to $21,000 and $69,000 for the same periods in fiscal year 2009.
A summary of the Companys restricted stock activity for the nine months ended March 31, 2010,
is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
Non-vested Restricted Shares |
|
Shares |
|
|
Grant Date Fair Value |
|
Non-vested at June 30, 2009 |
|
|
12,515 |
|
|
$ |
5.92 |
|
Granted |
|
|
|
|
|
|
|
|
Vested |
|
|
(12,359 |
) |
|
$ |
5.86 |
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested at March 31, 2010 |
|
|
156 |
|
|
$ |
10.53 |
|
|
|
|
|
|
|
|
|
As of March 31, 2010, there was approximately $800 of total unrecognized compensation cost
related to non-vested restricted stock awards granted under the Option Plan. That cost is expected
to be recognized over a weighted-average period of 0.4 years.
5. Fair Value Measurements
The Company measures certain assets 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:
|
|
|
Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active
markets; |
|
|
|
Level 2 inputs: Inputs, other than quoted prices included in Level 1 that are observable
either directly or indirectly; and |
|
|
|
Level 3 inputs: Unobservable inputs for which there is little or no market data, which
require the reporting entity to develop its own assumptions. |
12
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, 2010, the Company had $17.8 million invested in three money market funds and $5.0
million invested in certificates of deposit, that are included within the Cash and cash
equivalents and Short-term investments lines on the consolidated condensed balance sheet,
respectively. Because there is an active market for shares of these money market funds and the
certificates of deposit, the Company considers its fair value measure of this investment to be
based on Level 1 inputs.
See Note 7 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, 2010 that are
measured at fair value.
6. Shareholders Equity
On June 12, 2009, the Company entered into a $30.0 million common stock purchase agreement
with Fusion Capital Fund II, LLC, (Fusion Capital) an Illinois limited liability company. The
terms of the arrangement with Fusion Capital are disclosed in the Companys Annual Report on Form
10-K for the year ended June 30, 2009 and there have been no changes to the terms of this
arrangement during the quarter ended March 31, 2010.
During the nine months ended March 31, 2010, 1,718,538 shares of the Companys common stock
(including 51,432 shares related to its commitment fee) were issued to Fusion Capital for net
proceeds of $5,100,000.
On January 21, 2010, the Company also completed the sale of 6,509,637 units (including 740,387
units sold to the underwriter pursuant to the exercise of its over-allotment option) at a public
offering price of $2.08 per unit. Each unit consisted of (i) one share of common stock, (ii) a
Class A warrant to purchase 0.75 of a share of common stock at an exercise price of $2.97 per share
and (iii) a Class B warrant to purchase 0.50 of a share of common stock at an exercise price of
$2.08 per share. The Company received approximately $12.4 million in net proceeds from the sale of
the units (including the partially exercised option of the over-allotment), after underwriting
discounts and commissions and other offering expenses.
7. Stock Purchase Warrants
The Company had the following warrants to purchase shares of common stock of the Company
outstanding during the nine months ended March 31, 2009 and March 31, 2010:
|
(i) |
|
warrants to purchase an aggregate of 300,000 shares of the Companys common stock,
issued on April 5, 2004 in connection with the Companys registered direct offering,
exercisable for a five year period commencing on April 5, 2004 at an exercise price of
$13.20 per share, all of which expired unexercised; |
|
(ii) |
|
warrants to purchase an aggregate of 320,248 shares of the Companys common stock,
issued on October 27, 2004 in connection with the Companys registered direct offering,
exercisable from April 28, 2005 through October 27, 2008 at an exercise price of $13.92
per share, 229,855 of which expired unexercised; |
|
(iii) |
|
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; |
|
(iv) |
|
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 $2.97 per share; and |
|
(v) |
|
Class B warrants to purchase an aggregate of 3,254,818 shares of common stock, issued
on January 21, 2010 in connection with the Companys registered public offering,
exercisable at any time from January 21, 2010 through July 21, 2010 at an exercise price
of $2.08 per share. |
13
The foregoing warrants are recorded as liabilities at their estimated fair value at the date
of issuance, with subsequent changes in estimated fair value recorded in other income (expense) in
the Companys statement of operations in each subsequent period. The estimated fair value of the
warrants is determined using Level 3 inputs. The liability is measured using the Black Scholes
valuation model, which is based, in part, upon unobservable inputs for which there is little or no
market data, requiring the Company to develop its own assumptions. The assumptions used by the
Company are summarized in the following tables:
|
|
|
|
|
|
|
|
|
October 2007 Warrants |
|
June 30, 2009 |
|
|
March 31, 2010 |
|
Closing stock price |
|
$ |
3.36 |
|
|
$ |
1.65 |
|
Expected dividend rate |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
70.8 |
% |
|
|
77.0 |
% |
Risk free interest rate |
|
|
1.6 |
% |
|
|
1.6 |
% |
Expected life (years) |
|
|
3.75 |
|
|
|
3.00 |
|
|
|
|
|
|
|
|
|
|
January 2010 Class A Warrants |
|
January 21, 2010 |
|
|
March 31, 2010 |
|
Closing stock price |
|
$ |
1.84 |
|
|
$ |
1.65 |
|
Expected dividend rate |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
73.8 |
% |
|
|
71.0 |
% |
Risk free interest rate |
|
|
2.4 |
% |
|
|
2.6 |
% |
Expected life (years) |
|
|
5.50 |
|
|
|
5.25 |
|
|
|
|
|
|
|
|
|
|
January 2010 Class B Warrants |
|
January 21, 2010 |
|
|
March 31, 2010 |
|
Closing stock price |
|
$ |
1.84 |
|
|
$ |
1.65 |
|
Expected dividend rate |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
62.0 |
% |
|
|
69.6 |
% |
Risk free interest rate |
|
|
0.3 |
% |
|
|
0.4 |
% |
Expected life (years) |
|
|
0.50 |
|
|
|
0.25 |
|
The following table summarizes the changes in the estimated fair value of our warrant
liabilities (in thousands):
|
|
|
|
|
Warrant Liabilities |
|
|
|
|
Balance at June 30, 2009 |
|
$ |
532 |
|
Warrants issued |
|
|
5,649 |
|
Decrease in fair value |
|
|
(1,823 |
) |
|
|
|
|
Balance at March 31, 2010 |
|
$ |
4,358 |
|
|
|
|
|
8. 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, consisting of options, warrants for the
purchase of common stock and unvested restricted shares of common stock are not included in the per
share calculation where the effect of their inclusion would be anti-dilutive. The aggregate number
of common equivalent shares that have been excluded from the computations of net loss per common
share for the quarters ended March 31, 2009 and 2010 is approximately 2,555,000 and 11,215,000,
respectively.
14
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Restatement
As discussed in the Explanatory Note and Note 3 to this Amendment No. 2, we are amending
and restating our unaudited consolidated condensed financial statements and related disclosures for
all periods presented in this Amendment No. 2.
The following discussion and analysis of our financial condition and results of operations
incorporates the restated amounts. For this reason, the data set forth in this section may not be
comparable to discussion and data in our previously filed Quarterly Report on Form 10-Q, as amended
by Amendment No. 1, for the quarter ended March 31, 2010.
Overview of Aastrom
We focus on the development of innovative therapies to repair or regenerate damaged or
diseased tissues or organs. We are developing autologous cellular therapies for the treatment of
severe, chronic cardiovascular diseases. Using our proprietary Tissue Repair Cell (TRC) technology,
we are able to expand the number of stem and early progenitor cells from a small amount
(approximately 50 ml) of bone marrow collected from the patient. Early stage and clinical research
show that these cells may have efficacy in the repair of cardiac and other tissue.
With the use of our proprietary TRC technology, we produce personalized cell products
developed for site-specific delivery to repair or regenerate diseased or damaged tissue in
patients. Nearly 400 patients have been treated in clinical trials based on this therapeutic
approach over the past 10 years with no reported incidence of product safety problems or tissue
rejection.
Cardiac Regeneration
Our lead product is based on the application of autologous stem cells used to repair damaged
cardiac tissue. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to
our investigational therapy involving the use of TRCs in the treatment of dilated cardiomyopathy
(DCM). DCM is a severe, chronic cardiac disease that leads to enlargement of the heart and is
associated with reduced heart pumping function to the point that blood circulation is impaired. We
have advanced this development program with two U.S. Phase II trials investigating both a surgical
and a catheter-based delivery pathway for the use of CRCs in the treatment of DCM.
The first U.S. patient was treated with TRCs in our Phase II IMPACT-DCM surgical clinical
trial in November 2008. The trial was fully enrolled in January 2010 with 40 patients and the last
patient was treated in March 2010. The study is being conducted at five cardiovascular treatment
centers in the U.S., including: Methodist DeBakey Heart & Vascular Center in Houston, TX; Baylor
University Medical Center in Dallas, TX; The University of Utah School of Medicine in Salt Lake
City, UT; Cleveland Clinic Heart & Vascular Institute in Cleveland, OH; and Emory University
Hospital Midtown in Atlanta, GA. We anticipate collecting 6-month interim data from this trial upon
completion of the 6-month follow-up visits for all patients during the third quarter of calendar
year 2010. We are planning to report interim analysis results in the fourth quarter of calendar
year 2010.
Our second cardiac trial, a U.S. Phase II cardiac catheter clinical trial has been designed to
explore a catheter-based delivery of TRCs to treat DCM patients. Clinical site training for this
trial was initiated during the fourth quarter of calendar year 2009, and we enrolled our first
patient in April 2010.
Vascular Regeneration
Our TRC technology has also shown promise in the treatment of an advanced stage of peripheral
arterial disease (PAD) called critical limb ischemia (CLI). Patients with CLI generally have
painful wounds on their feet (or hands) that do not heal due to poor blood circulation, often
leading to amputation. More than 160,000 amputations per year are associated with CLI. Our U.S.
Phase IIb RESTORE-CLI clinical trial is investigating the safety and efficacy of TRCs in the
treatment of patients with this severe, chronic disease compared with placebo; neither patients nor
physicians know the treatment received during the study.
In February 2010 a planned interim analysis was performed for this study on 46 patients having
completed at least 6 months of the study. According to the interim analysis, the safety profile was
similar between the treatment and placebo patients. Based on a composite efficacy endpoint assessing time to treatment failure (including major amputations,
doubling of wound size and new gangrene), our autologous TRCs were more effective than placebo
(p<0.05). Other clinically meaningful endpoints (e.g., major amputation rate, complete wound
healing) individually showed encouraging trends, but have not yet reached statistical significance
at the interim analysis.
15
The interim analysis was planned to assess performance of TRCs and to help plan further
studies. Based on the interim findings, we concluded enrollment of new patients in order to
complete the study as soon as possible, and to begin planning and discussions with the FDA for
pivotal clinical trials in CLI. The last patient enrolled in this trial was treated on March 23,
2010, for a total of 86 patients who will be followed for 12 months per protocol.
The TRC Technology Platform
TRCs are a cellular therapy developed using our proprietary TRC technology, an automated
processing system utilizing single-pass perfusion to manufacture human cell products for clinical
use. The system meets all Good Manufacturing Practices (GMP) guidelines. TRC-based therapies begin
with a small amount of the patients own bone marrow to produce large numbers of stem and early
progenitor cells. This mixture of cell types is capable of developing into cardiac, vascular and
other tissues.
Our cell products have three features that we believe are critical for success in regenerative
medicine. Cellular therapies based on our TRC technology are:
|
|
autologous, which means 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 organs, and provide long-term engraftment and repair; |
|
|
|
expanded, resulting in significantly higher concentrations of stem and progenitor cells than
occur naturally, especially for older patients; and, |
|
|
|
a mixed population of cells, which includes all of the most important cell types required for
tissue regeneration and found in natural bone marrow and are required for tissue regeneration. |
All TRC-based products are manufactured at centralized facilities. We have our primary cell
processing facility in the U.S. located at our headquarters in Ann Arbor, MI, and two contract
facilities in the E.U. located in Stuttgart, Germany (Fraunhofer Institute for Interfacial
Engineering and Biotechnology) and Bad Oeynhausen, Germany (Institute of Laboratory and Transfusion
Medicine at the Heart Center).
Since our inception, we have been a development-stage company engaged in research and product
development conducted principally on our own behalf. We are focused the development of products
based on our TRC technology platform for use in cardiovascular indications. We currently generate
minimal product sales involving cell-therapy based products to physicians in the United States. At
such time as we satisfy applicable regulatory approval requirements, we expect the sales of
therapies based on our TRC technology platform to constitute nearly all of our revenue from product
sales.
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 TRC-based cell product sales. Until
that time, we expect that revenue sources from our current activities will consist of only minor
sales of our cell products 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
alliances or other operational strategies to advance our product development programs including
completion of our clinical research programs and commercialization of 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 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 are achieved. With respect to our current activities,
profitability 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, 2010, we have accumulated a net loss of approximately $207 million. We
cannot provide any assurance that we will achieve profitability or obtain the required funding,
regulatory approvals or complete additional corporate partnering or acquisition transactions
to advance our products to commercial-stage development.
16
Clinical Development
Our clinical development programs are focused on the utilization of our TRCs for cardiac and
vascular regeneration. Our TRC-based cell therapies have a 72-hour shelf-life which we believe
provides additional flexibility in transport and scheduling treatment for patients.
The mixture of cell types in TRC-based therapies is capable of developing into cardiac,
vascular and other tissues. We have demonstrated in the laboratory that cells in TRC-based
therapies can differentiate into endothelial (blood vessel) lineages. In addition, TRC treatment in
both rat and mouse models of critical limb ischemia have shown evidence of angiogenesis and
increased tissue perfusion, respectively. These preclinical observations support our current
clinical-stage research at treatment centers where we are exploring the use of TRC-based therapies
to regenerate cardiac tissue in patients with dilated cardiomyopathy and vascular tissue in
patients with critical limb ischemia.
Results to date in our current clinical trials may not be indicative of results obtained from
subsequent patients in those trials or from future clinical trials. Further, our future clinical
trials may not be successful and we may not be able to obtain the required Biologic License
Application (BLA) registration in the U.S. or required foreign regulatory approvals for our
TRC-based products in a timely fashion, or at all.
Clinical Trials Summary
Cardiac Regeneration
Dilated Cardiomyopathy Background
DCM is a severe, chronic cardiac disease that leads to enlargement of the heart and is
associated with reduced heart pumping function 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. DCM generally occurs in patients who have
ischemic heart failure due to multiple heart attacks, though it can also be found in patients with
non-ischemic heart failure caused by hypertension, viral infection, metabolic abnormalities and
other causes. Patient prognosis depends on the stage of the disease but is typically characterized
by a high mortality rate. Other than heart transplantation, there are currently no curative
treatment options for end-stage patients with this disease. The New England Journal of Medicine
estimates that in the U.S. alone 120,000 people currently suffer from this disease; other sources
estimate that the patient population with DCM may be as high as 150,000.
Early clinical data in the treatment of DCM with TRCs was obtained from two DCM patients
treated in 2007 at the University Hospital in Düsseldorf, Germany. These two patients showed 15-20%
improvement in their left ventricular ejection fraction approximately 2 months after treatment with
TRCs. One patient maintained this improvement after 7 months of follow-up; however, the other died
due to natural causes after declining further medical treatment. These data provided supportive
information critical to the success of the U.S. Phase II IMPACT-DCM IND application.
Dilated Cardiomyopathy Surgical Trial
In November 2008, the first patient was treated in the 40-patient U.S. IMPACT-DCM surgical
trial to evaluate TRCs in the treatment of DCM. This randomized, controlled, prospective,
open-label, Phase II study was designed using two strata to include 20 patients with ischemic DCM
and 20 patients with non-ischemic DCM. TRCs, manufactured using our TRC technology, received Orphan
Drug Designation from the FDA for the treatment of DCM in February 2007. The FDA activated our
Investigational New Drug (IND) application for this clinical trial in May 2008.
Full IMPACT-DCM enrollment of 40 patients was completed in January 2010 with the final patient
treated in March 2010 and with patients enrolled at five U.S. clinical sites (Methodist DeBakey
Heart & Vascular Center, Houston, TX, Baylor University Medical Center, Dallas, TX, The University
of Utah School of Medicine, Salt Lake City, UT, Cleveland Clinic Heart & Vascular Institute,
Cleveland, OH, and Emory University Hospital Midtown, Atlanta, GA). We anticipate collecting
6-month interim data from this trial upon completion of 6-month follow-up visits for all patients during the third
quarter of calendar year 2010; the interim analysis results are planned to be reported in the
fourth quarter of calendar year 2010.
17
Participants in the IMPACT-DCM clinical trial have to be in New York Heart Association (NYHA)
functional class III or IV heart failure, must have an LVEF of less than or equal to 30% (60-75% is
typical for a healthy person), and meet certain other eligibility criteria. The IMPACT-DCM trial is
a controlled trial and patients are randomized in an approximate 3:1 ratio to the treatment versus
the control group within each stratum. All patients receive optimal medical therapy and patients in
the treatment group are treated with CRCs through direct injection into the heart muscle during
minimally invasive open heart surgery (involving an incision of approximately 2 inches). While the
primary objective of this study is to assess the safety of TRCs in patients with DCM (including the
incidence of ectopy and arrhythmia as well as major adverse cardiac events), efficacy measures
including 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 will be monitored. NYHA functional class and quality of life are also assessed.
Patients will be followed for 12 months post-treatment.
Dilated Cardiomyopathy Catheter Trial
We have expanded our ongoing clinical program to evaluate TRCs in the treatment of severe
heart failure patients with a second U.S. Phase II cardiac regeneration trial designed to explore a
catheter-based delivery of TRCs to treat DCM patients. The first patient was enrolled into the
trial in April 2010.
This randomized, controlled, prospective, open-label, Phase II study seeks to enroll 12
patients with ischemic DCM and 12 patients with non-ischemic DCM at four clinical sites in the U.S.
Participants must be in NYHA functional class III or IV heart failure, must have an LVEF of less
than or equal to 30% (60-75% is typical for a healthy person) and meet certain additional
eligibility criteria. All 24 patients will receive optimal medical therapy and 16 of the patients
(8 ischemic and 8 non-ischemic) will also be treated with TRCs via catheter injection. The catheter
trial will randomize patients in an approximate 2:1 ratio to the treatment versus control group
within each ischemic/non-ischemic stratum. While the primary objective of this study is to assess
the safety of TRCs delivered by catheter injection in patients with DCM, efficacy measures
including heart failure stage and cardiac function parameters will also be assessed. Patients will
be followed for 12 months post-treatment.
Vascular Tissue Regeneration
Critical Limb Ischemia Background
Peripheral Arterial Disease (PAD) is a chronic 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. CLI is typically the end stage of PAD disease. Patients suffering from this condition are
critically ill, with a high risk of amputation. These patients are extremely limited in their
ambulatory capacity, experience constant and chronic ischemia-induced pain, ulcers, tissue loss or
gangrene to the limbs, which lead to approximately 160,000 amputations per year.
Laboratory observations have shown that TRC-based products have the ability to form small
blood vessel-like structures in vitro. TRC treatment in both rat and mouse models of critical limb
ischemia have shown evidence of angiogenesis and increased tissue perfusion, respectively. These
preclinical observations support our current clinical-stage research where we are exploring the use
of TRC therapies to regenerate vascular tissue in patients with CLI.
Initial results from the first clinical trial of TRCs in CLI were reported in October 2007.
The trial examined the safety of TRCs and unexpanded bone marrow cells relative to standard of care
in treatment of chronic diabetic foot wounds. Initial results from 13 patients after 12 month
follow-up indicated similar safety profiles, with no cell-related adverse events reported. No major
amputations were reported in the TRC group (N=4), one in the unexpanded bone marrow cell group
(N=7), and one in the standard of care group (N=2). Patients in the TRC group and in the unexpanded
bone marrow group reported healing of all open wounds; this was not observed in the standard of
care group.
18
Critical Limb Ischemia Trial
Following the interim clinical results from Germany, we initiated the RESTORE-CLI trial, a
U.S. Phase IIb prospective, controlled, randomized, double-blind, multi-center clinical trial to
treat patients suffering from CLI. This trial is designed to evaluate the safety and efficacy of
TRCs in the treatment of CLI. Patients are being followed for a period of 12 months post-treatment.
In addition to assessing the safety of TRCs, secondary endpoints include the measurement of time to
treatment failure, major amputation rates, level of amputation, complete wound healing, blood flow
in affected limbs, patient quality of life, pain scores and analgesic use.
In February 2010 a planned interim analysis was performed for this study on 46 patients having
completed at least 6 months of the study. We reported the safety profile was similar between the
treatment and control patients. Importantly, we reported that our autologous TRCs were more
effective than placebo (p>.0090), based on a composite efficacy endpoint assessing time
to treatment failure (including major amputations, doubling of wound size or new gangrene). Other
clinically meaningful endpoints (e.g., major amputation rate, complete wound healing) individually
showed encouraging trends, but have not yet reached statistical significance at the interim
analysis.
The interim analysis was planned to assess performance of TRCs in the CLI patient population
and to help plan further studies. Based on the interim findings, we concluded enrollment of new
patients in February 2010 in order to complete the study as rapidly as possible, and to begin
planning and discussions with the FDA for pivotal clinical trials in CLI. The last patient enrolled
in this trial was treated on March 23, 2010.
Results of Operations
Total revenues, consisting of product sales, for the quarter and nine months ended March 31,
2010 were $0 and $89,000, respectively, compared to $58,000 and $113,000, respectively, for the
same periods in fiscal year 2009. The fluctuations in product sales is due to the changes in volume
of cell production sales for investigator-sponsored clinical trials in Spain and limited cell
manufacturing supplies to a research institute in the U.S. At such time as we satisfy applicable
regulatory approval requirements, we expect the sales of our TRC cell-based products will
constitute nearly all of our product sales revenues.
Total costs and expenses increased to $4,263,000 for the quarter ended March 31, 2010,
compared to $4,070,000 for the quarter ended March 31, 2009.
Costs and expenses include an increase in research and development expenses to $2,845,000 for
the quarter ended March 31, 2010 from $2,785,000 for the quarter ended March 31, 2009. This
increase reflects continued expansion of our clinical development activities including the costs
associated with recruitment and treatment of patients in our IMPACT-DCM clinical trial. Research
and development expenses also included a non-cash charge relating to share-based compensation
expense of $146,000 for the quarter ended March 31, 2010 compared to $100,000 for the quarter ended
March 31, 2009. A reversal of $171,000 was recorded for the quarter ended March 31, 2010, in
share-based compensation expense for certain stock options no longer expected to vest related to
employee terminations and forfeitures.
Selling, general and administrative expenses increased for the quarter ended March 31, 2010 to
$1,418,000 from $1,260,000 for the quarter ended March 31, 2009. This increase is primarily the
result of increased legal fees and contract services. Selling, general and administrative expenses
for the quarter ended March 31, 2010, included a non-cash charge relating to share-based
compensation expense of $225,000 compared to $273,000 for the quarter ended March 31, 2009. A
reversal of $125,000 was recorded for the quarter ended March 31, 2010, in share-based compensation
expense for certain stock options no longer expected to vest related to employee terminations and
forfeitures.
Total costs and expenses increased to $12,753,000 for the nine months ended March 31, 2010,
compared to $12,296,000 for the nine months ended March 31, 2009.
Research and development expenses increased for the nine months ended March 31, 2010 to
$9,039,000 from $8,340,000 for the nine months ended March 31, 2009. This increase reflects
continued expansion of our clinical development activities including the costs associated with
recruitment and treatment of patients in our IMPACT-DCM clinical trial. Research and development
expenses also included a non-cash charge relating to stock-based compensation expense of $506,000
for the nine months ended March 31, 2010 compared to $435,000 for the nine months ended March 31,
2009. A reversal of $171,000 was recorded for the nine months ended
March 31, 2010, in share-based compensation expense for certain stock options no longer
expected to vest related to employee terminations and forfeitures.
19
Selling, general and administrative expenses decreased for the nine months ended March 31,
2010 to $3,680,000 from $3,909,000 for the nine months ended March 31, 2009. This decrease is
primarily due to an offset of $404,000 in share-based compensation expense recorded for certain
stock options no longer expected to vest related to employee terminations and forfeitures. Selling,
general and administrative expenses for the nine months ended March 31, 2010, included a non-cash
charge relating to share-based compensation expense of $494,000 compared to $694,000 for the nine
months ended March 31, 2009.
Income (expense) from the change in fair value of warrants was $1,559,000 and $1,823,000 for
the quarter and nine months ended March 31, 2010, respectively, compared to $481,000 and $(61,000)
for the quarter and nine months ended March 31, 2009, respectively. The fluctuations are due
primarily to issuances of warrants in the January 2010 financing and changes in the fair value of
our common stock and the related impact on our warrant liabilities.
Interest income was $34,000 and $83,000, respectively, for the quarter and nine months ended
March 31, 2010 compared to $57,000 and $253,000, respectively, for the same periods in fiscal 2009.
The fluctuations in interest income are due primarily to corresponding changes in the level of
cash, cash equivalents and short-term investments during the periods and lower interest rates.
Interest expense was $9,000 and $33,000, respectively, for the quarter and nine months ended
March 31, 2010 compared to $17,000 and $58,000, respectively, for the same periods in fiscal 2009.
Interest expense is related to the secured loan with Key Equipment Finance Inc.
Our
net loss was $2,679,000, or $0.10 per common share for the quarter ended March 31, 2010
compared to $3,491,000, or $0.19 per common share for the quarter ended March 31, 2009. For the
nine months ended March 31, 2010, our net loss decreased to $10,791,000, or $0.47 per common share
compared to a net loss of $12,049,000, or $0.70 per common share for the nine months ended March
31, 2009. The fluctuations are due primarily to the change in fair value of warrants as described
above.
On April 27, 2010, Moll Industries, a supplier of the cell culture cassettes used in the
production of TRC-based products, filed for bankruptcy protection in a Delaware court. Although we
believe we have adequate supplies of these materials for our anticipated uses, there can be no
assurance that we will be able to continue our present arrangements with Moll or, if necessary,
establish new relationships on the same or similar terms as we have with Moll. Although we
anticipate that the cell culture cassettes will be able to be manufactured for us on the same or
similar terms as Moll is currently providing, any increase in the cost of these cassettes could
increase our research and development expense which may have a material adverse affect on our
business, financial condition and results of operations. See Part I, Item 1A, Risk Factors in our
Annual Report on Form 10-K for the year ended June 30, 2009.
Our major ongoing research and development programs are focused on the clinical development of
TRC-based products, bone marrow-derived adult stem and early progenitor cells, for use in cardiac
regeneration, as well as vascular regeneration. We have reprioritized our clinical development
programs to focus on cardiovascular applications including our Phase II IMPACT-DCM (dilated
cardiomyopathy) trial and our Phase IIb RESTORE-CLI (critical limb ischemia) trial. These potential
product applications use TRC technology, our proprietary cells and platform manufacturing
technologies. We are also completing other research and development activities using our TRC-based
products that are intended to improve the functionality for certain clinical indications and to
decrease the cost of manufacturing our TRC-based products.
Because of the uncertainties of clinical trials and the evolving regulatory requirements
applicable to TRC-based products, estimating the completion dates or cost to complete our major
research and development program would be highly speculative and subjective. The risks and
uncertainties associated with developing our products, including significant and changing
governmental regulation and the uncertainty of future clinical study results, are discussed in
greater detail in the Any changes in the governmental regulatory classifications of our products
could prevent, limit or delay our ability to market or develop our products, Our inability to
complete our product development activities successfully would severely limit our ability to
operate or finance operations, and We must successfully complete our clinical trials to be able
to market certain of our products in Part I, Item 1A, Risk Factors in our Annual Report on Form
10-K for the year ended June 30, 2009. The potentially lengthy process of seeking regulatory
approvals for our product candidates, and the subsequent compliance with applicable regulations,
will require the expenditure of substantial resources. Any failure by us to obtain, or any delay in
obtaining, regulatory approvals could cause our research and development
expenditures to increase and, in turn, have a material adverse effect on our results of
operations. We cannot be certain when any net cash inflow from products validated under our major
research and development project, if any, will commence.
20
Liquidity and Capital Resources
We have financed our operations since inception primarily through public and private sales of
our equity securities, which, from inception through March 31, 2010, have totaled approximately
$218 million 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, and funding under equipment leasing agreements. These financing sources have generally
allowed us to maintain adequate levels of cash and other liquid investments.
Our combined cash and cash equivalents and short-term investments totaled $22,844,000 at March
31, 2010, an increase of $5,844,000 from June 30, 2009. During the nine months ended March 31,
2010, the primary source of cash and cash equivalents was from equity transactions, of which net
proceeds of $17,500,000 were raised through sales of our equity securities pursuant to the June
2009 agreement with Fusion Capital and an underwritten public offering of public offering of our
common stock and warrants. The primary uses of cash and cash equivalents during the nine months
ended March 31, 2010 included $11,430,000 to finance our operations and working capital
requirements, and $103,000 in capital equipment additions. Our combined cash and cash equivalents
at April 30, 2010 was approximately $21,556,000.
In our underwriting agreement with Oppenheimer & Co. Inc., we have agreed not to issue or sell
any securities under our existing financing agreement with Fusion Capital or otherwise enter into
any similar equity financing program with any third party for a period of 180 days from the date of
the prospectus supplement (January 15, 2010) without the prior written consent of Oppenheimer & Co.
Inc. Pursuant to our financing agreement with Fusion Capital we are not able to put shares to
Fusion Capital for purchase so long as our stock price is below $2.88.
Our monthly cash utilization has average approximately $1.3 million for the nine months ended
March 31, 2010. We expect our monthly cash utilization for the remainder of fiscal year 2010 to
average approximately $1.4 million per month due to increased expenses to conduct our IMPACT-DCM
clinical trial.
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 a positive cash flow 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. We expect that our available cash and expected interest income will be sufficient to
finance current planned activities at least through March 31, 2011, in part due to the fact that
many of our expenditures are discretionary in nature and could, if necessary, be delayed. These
estimates are based on certain assumptions. See Results of Operations above. In order to grow and
expand our business, to introduce our product candidates into the marketplace and to 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. If our common stock is delisted from the
NASDAQ Stock Market, the liquidity of our common stock could be impaired, and prices paid by
investors to purchase our shares of our common stock could be lower than might otherwise prevail.
21
On January 21, 2010, we completed the sale of 6,509,637 units (including 740,387 units sold to
the underwriter pursuant to the exercise of its over-allotment option) at a public offering price
of $2.08 per unit. Each unit consisted of (i) one share of common stock,
(ii) a Class A warrant to purchase 0.75 of a share of common stock at an exercise price of
$2.9744 per share and (iii) a Class B warrant to purchase 0.50 of a share of common stock at an
exercise price of $2.08 per share. We received approximately $12.4 million in net proceeds from the
sale of the units (including the partially exercised option of the over-allotment), after
underwriting discounts and commissions and other offering expenses.
The 6,509,637 units consist of an aggregate of 6,509,637 shares of our common stock, Class A
Warrants to purchase an aggregate of 4,882,228 shares of common stock and Class B Warrants to
purchase an aggregate of 3,254,818 shares of common stock. The Class A Warrants are exercisable for
a five year period commencing on July 21, 2010. The Class B Warrants are exercisable at any time
from January 21, 2010 through July 21, 2010.
If adequate funds are not available, we may be required to delay, reduce the scope of, or
eliminate one or more of our research and development programs, which may have a material adverse
affect on our business. See Part I, Item 1. Financial Statements Notes to Consolidated
Financial Statements in this Quarterly Report on Form 10-Q/A and Notes to Consolidated Financial
Statements in our Annual Report on Form 10-K for the year ended June 30, 2009.
Off-Balance Sheet Arrangements
At March 31, 2010, we were not party to any off-balance sheet arrangements.
Forward-Looking Statements
This report, including the documents that we incorporate by reference, contain forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. 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 Annual Report on Form 10-K for the year-ended June 30, 2009. Such
factors, 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, unless required by law, 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.
Among the factors about which we have made assumptions are:
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potential strategic collaborations with others; |
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future capital needs and expected cash flows; |
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adequacy of existing capital to support operations for a specified time; |
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the rate and degree of progress on our product development and marketing plans; |
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the rate of regulatory approval to proceed with clinical trial programs and the
success achieved in clinical trials;
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enrollment in and results of our clinical trials; |
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the requirements for marketing authorization from regulatory bodies in the U.S.,
E.U.and other countries; |
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the liquidity and market volatility of our equity securities; |
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the continued listing of our securities on the NASDAQ Capital Market; |
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regulatory and manufacturing requirements and uncertainties; |
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technological developments by competitors; |
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anticipation of future losses; |
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replacement of manufacturing sources; |
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our products and commercialization plans; and |
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revenue expectations and operating results. |
For further information on factors which could impact us and the statements contained herein,
see Part I, Item 1A, Risk Factors in our Annual Report on Form 10-K for the fiscal year ended
June 30, 2009.
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,
2010. The term disclosure controls and procedures is defined in Rules 13a-15(e) and 15d-15(e)
under the Securities and Exchange Act of 1934 (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.
At the time that our Quarterly Report on Form 10-Q, as amended by Amendment No. 1, for the
quarter ended March 31, 2010 was filed on May 13, 2010, our Chief Executive Officer and Chief
Financial Officer concluded that our disclosure controls and procedures were effective as of March
31, 2010. Subsequent to that evaluation, our management, including our Chief Executive Officer and
Chief Financial Officer, concluded that our disclosure controls and procedures were not effective
to provide reasonable assurance as of March 31, 2010 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. We did not maintain effective controls 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 material 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, 2008, 2009 and 2010, 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 (the
Affected Periods) as discussed below and in Note 3 to the consolidated financial statements
included in this Quarterly Report on Form 10-Q/A. 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.
23
Restatement of Consolidated Financial Statements
On February 11, 2011, in connection with responding to certain comments raised by the Staff of
the SEC in its periodic review of the Companys SEC filings, the Company in consultation with its
Audit Committee, concluded that its previously issued consolidated financial statements for the
Affected Periods should be restated because of a misapplication in the guidance around accounting
for warrants and should no longer be relied upon. However, the non-cash adjustments to the
financial statements, in all of the Affected Periods, do not impact the amounts previously reported
for the Companys cash and cash equivalents, operating expenses or cash flows.
Remediation Plan
Management has been actively engaged in developing a remediation plan to address the material
weakness. Implementation of the remediation plan is in process and consists of the hiring of new
accounting/finance personnel and their revisiting the original accounting assessment for each of
their historical warrants and assessing the original accounting and the on-going accounting impact.
Management has completed this assessment during February 2011 and the results of this analysis
have been used to adjust the Affected Periods in the restated documents.
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 plan 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, 2010 that have materially affected, or are reasonably likely to
materially affect, the Companys internal control over financial reporting.
24
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 2. Unregistered Sales of Equity Securities and Use of Proceeds
On June 12, 2009, the Company entered into a $30.0 million common stock purchase agreement
with Fusion Capital, an Illinois limited liability company. The terms of the arrangement with
Fusion Capital are disclosed in the Companys Annual Report on Form 10-K for the year ended June
30, 2009 and there have been no changes to the terms of this arrangement during the quarter ended
March 31, 2010.
The Company did not issue any unregistered securities during the three months ended March 31,
2010. During the nine months ended March 31, 2010, 1,769,970 shares of the Companys common stock,
including 51,432 shares issued as payment of the Companys commitment fee were issued to Fusion
Capital for net proceeds of $5,100,000. The Company has an effective registration statement
covering the resale by Fusion Capital of all of these shares under the Securities Act of 1933, as
amended.
Item 6. Exhibits
The Exhibits listed in the Exhibit Index immediately following the Signatures, are filed as a
part of this Quarterly Report on Form 10-Q/A.
25
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: February 24, 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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EXHIBIT INDEX
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Exhibit Number |
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Description |
4.1
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Class A Warrant Agreement, dated as of January 21, 2010, by and between the Registrant and
Continental Stock Transfer & Trust Company (incorporated herein by reference to Exhibit 4.1 to the
Companys Current Report on Form 8-K filed with the SEC on January 27, 2010) |
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4.2
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Class B Warrant Agreement dated as of January 21, 2010, by and between the Registrant and
Continental Stock Transfer & Trust Company (incorporated herein by reference to Exhibit 4.2 to the
Companys Current Report on Form 8-K filed with the SEC on January 27, 2010) |
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10.1
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Underwriting Agreement, dated as of January 15, 2010, and between the Registrant and Oppenheimer &
Co. Inc. (incorporated herein by reference to Exhibit 1.1 to the Companys Current Report on Form
8-K filed with the SEC on January 15, 2010) |
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31.1
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Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2
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Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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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) |
27
GLOSSARY
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TERM |
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DEFINITION |
Adult Stem Cell
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A cell present in adults that can generate a limited range of
cell types as well as renew itself. |
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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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AEMPS Agencia Española de Medicamentos y
Productos Sanitarios
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Spanish Drug Agency |
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Allogeneic
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Originating from a human donor other than the patient
receiving treatment (Aastrom does NOT use allogeneic cells). |
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ATMP Advanced Therapy Medicinal Product
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New medicinal products in the European Union based on genes
(gene therapy), cells (cell therapy) and tissues (tissue
engineering). |
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Autologous
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Originating from the patient receiving treatment. (Aastrom
uses only autologous cells) |
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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 (equivalent to NDA) |
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CBER Center for Biologics Evaluation and
Research
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Branch of the FDA that regulates biological products for
disease prevention and treatment that are inherently more
complex than chemically synthesized pharmaceuticals. |
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CLI Critical Limb Ischemia
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A vascular disease characterized by insufficient blood flow in
the 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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CRC Cardiac Repair Cell
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Aastroms proprietary Tissue Repair Cells for cardiac
indications. (Also see TRC Tissue Repair Cell) |
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DCM Dilated Cardiomyopathy
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A chronic cardiac disease where dilation of the patients
heart reduces its 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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EMEA European Medicines Agency
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European Union body responsible for coordinating the existing
scientific resources put at its disposal by Member States for
the evaluation, supervision and pharmacovigilance of medicinal
products. The Agency provides the Member States and the
institutions of the E.U. scientific advice on any question
relating to the evaluation of the quality, safety and efficacy
of medicinal products for human or veterinary use referred to
it in accordance with the provisions of E.U.legislation
relating to medicinal products. EMEA is similar in function to
the US FDA (see FDA below). |
28
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TERM |
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DEFINITION |
E.U. European Union
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The economic and political union of 27 member states, located
primarily in Europe, for which the EMEA holds the medical
regulatory power. |
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Ex vivo
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Outside the body |
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FDA Food and 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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GCP Good Clinical Practice
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GCP is an international ethical and scientific quality
standard for designing, conducting, recording and reporting
trials that involve the participation of human subjects.
Compliance with this standard provides public assurance that
the rights, safety and well-being of trial subjects are
protected, consistent with the principles that have their
origin in the Declaration of Helsinki, and that the clinical
trial data are credible. |
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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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GTP Good Tissue Practice
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GTP regulations help ensure that donors of human cellular and
tissue-based products are free of communicable diseases and
that the cells and tissues are not contaminated during
manufacturing and maintain their integrity and function. Key
elements of the proposed rule are: Establishment of a quality
program, which would evaluate all aspects of the firms
operations, to ensure compliance with GTP; Maintenance of an
adequate organizational structure and sufficient personnel;
Establishment of standard operating procedures for all
significant steps in manufacturing; Maintenance of facilities,
equipment and the environment; Control and validation of
manufacturing processes; Provisions for adequate and
appropriate storage; Record keeping and management;
Maintenance of a complaint file; Procedures for tracking the
product from donor to recipient, and from recipient to donor. |
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Hematopoietic Stem Cells
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Stem cells that give rise to all blood cell types including
myeloid (monocytes and macrophages, neutrophils, basophils,
eosinophils, erythrocytes, megakaryocytes/platelets, dendritic
cells), and lymphoid lineages (T-cells, B-cells, NK-cells). |
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IMPACT-DCM
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Aastroms U.S. Phase II surgical clinical trial evaluating the
use of CRCs in the treatment of dilated cardiomyopathy. |
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IMPD Investigational Medicinal Product Dossier
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An IMPD is now required to accompany an application to perform
clinical trials in any European Member State. It provides a
summary of information on the quality of the product being
evaluated in a clinical trial planned to occur in a European
Member State, including reference products and placebos. It
also provides data from non-clinical studies and available
previous clinical experience with the use of the
investigational medicinal product. |
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In vitro
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In a laboratory dish or test tube; in an artificial environment |
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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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TERM |
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DEFINITION |
IRB Institutional Review Board
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A committee designated to formally approve, monitor, and
review biomedical research at an institution involving humans.
Institutional Review Boards aim to protect the rights and
welfare of the research subjects. For Aastrom-sponsored
clinical trials, IRB approval must be obtained at each
individual clinical site in order for patient recruitment and
treatment to commence at that site. |
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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 treatment. |
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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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Phase I Clinical Trial
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A Phase I trial represents an initial study in a small group
of patients to test for safety and other relevant factors |
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Phase II Clinical Trial
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A Phase II trial represents a study in a small number of
patients to assess the safety and efficacy of a product |
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Phase IIb Clinical Trial
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A Phase IIb trial is a moderately-sized Phase II study that is
more specifically designed assess the efficacy of a product
than a Phase IIa trial |
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Phase III Clinical Trial
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Phase III studies are initiated to establish safety and
efficacy in an expanded patient population at multiple
clinical study sites and are generally larger than trials in
earlier phases of development. |
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Progenitor Cells
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A parent cell that gives rise to a distinct cell lineage by
a series of cell divisions. |
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Prospective Clinical Trial
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A clinical trial in which participants are identified and then
followed for the duration of the clinical trial. |
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Randomized Clinical Trial
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A clinical trial in which the participants are assigned
randomly to treatment and control groups. |
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Somatic Cell
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Any of the cells responsible for forming the body of an
organism such as internal organs, bones, skin, connective
tissues and blood. |
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SPP Single-Pass Perfusion
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SPP is Aastroms proprietary technology that controls gas and
cell culture media exchange to enable the replication of
early-stage stem and progenitor cells while preventing their
differentiation into mature cells. |
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Standard of care treatment
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The treatment normally prescribed in medical practice for a
particular illness, injury or procedure. |
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Stem Cell
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Unspecialized (undifferentiated) cells that retain the ability
to divide throughout a lifetime and give rise to more
specialized (differentiated) cells which take the place of
cells that die or are lost.
In culture, these undifferentiated cells possess the ability
to divide for indefinite periods in culture and may give rise
to highly specialized cells. |
30
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TERM |
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DEFINITION |
TRC Tissue Repair Cell
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Aastroms cell manufacturing process begins with the
collection of a small aspirate (approximately 50 ml) of bone
marrow from the patients hip in an outpatient procedure. The
sample of bone marrow is shipped to a manufacturing facility,
and transferred into Aastroms cell manufacturing system. In
this fully automated, sterile process, the stem and progenitor
cell populations present in the bone marrow are greatly
expanded to yield cellular products based on Aastroms Tissue
Repair Cell (TRC) technology. The finished TRC-based product
is shipped back to the physician who administers it to the
original patient as an autologous cell therapy. |
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VRC Vascular Repair Cell
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Aastroms proprietary Tissue Repair Cells for Vascular
indications. (Also see TRC Tissue Repair Cell) |
31
exv31w1
EXHIBIT 31.1
CERTIFICATION
I, Timothy M. Mayleben, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q/A of Aastrom Biosciences, Inc. for the
quarter ended March 31, 2010;
2. 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;
3. 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;
4. The registrants other certifying officer(s) 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:
(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; and
(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; and
(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
(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.
5. The registrants other certifying officer(s) 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):
(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
(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.
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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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Date: February 24, 2011
exv31w2
EXHIBIT 31.2
CERTIFICATION
I, Scott C. Durbin, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q/A of Aastrom Biosciences, Inc. for the
quarter ended March 31, 2010;
2. 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;
3. 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;
4. The registrants other certifying officer(s) 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:
(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; and
(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; and
(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
(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.
5. The registrants other certifying officer(s) 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):
(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
(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.
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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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Date: February 24, 2011
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/A for the quarter ended March 31, 2010, 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:
(1) The Report fully complies with the requirements of Section 13(a) and 15(d) of the
Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
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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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Date: February 24, 2011
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.