e10vq
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2009,
OR
|
|
|
o |
|
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)
|
|
|
Michigan
|
|
94-3096597 |
|
|
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. employer
identification no.) |
|
|
|
24 Frank Lloyd Wright Dr. |
|
|
P.O. Box 376 |
|
|
Ann Arbor, Michigan
|
|
48106 |
|
|
|
(Address of principal executive offices)
|
|
(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 - þ No - o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Large accelerated filer - o
|
|
Accelerated filer - þ
|
|
Non-accelerated filer - o
|
|
Smaller reporting company - þ |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
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.
|
|
|
COMMON STOCK, NO PAR VALUE
|
|
158,769,831 |
(Class)
|
|
Outstanding at May 1, 2009 |
AASTROM BIOSCIENCES, INC.
Quarterly Report on Form 10-Q
March 31, 2009
TABLE OF CONTENTS
2
PART
I - FINANCIAL INFORMATION
Item 1. Financial Statements
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
CONSOLIDATED CONDENSED BALANCE SHEETS
(Unaudited)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
March 31, |
|
|
|
2008 |
|
|
2009 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
16,492 |
|
|
$ |
19,076 |
|
Short-term investments |
|
|
5,970 |
|
|
|
|
|
Receivables, net |
|
|
18 |
|
|
|
254 |
|
Other current assets |
|
|
1,583 |
|
|
|
959 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
24,063 |
|
|
|
20,289 |
|
|
|
|
|
|
|
|
|
|
PROPERTY AND EQUIPMENT, NET |
|
|
2,154 |
|
|
|
1,666 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
26,217 |
|
|
$ |
21,955 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
907 |
|
|
$ |
884 |
|
Accrued employee benefits |
|
|
747 |
|
|
|
355 |
|
Current portion of long-term debt |
|
|
446 |
|
|
|
471 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,100 |
|
|
|
1,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM DEBT |
|
|
783 |
|
|
|
427 |
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS EQUITY: |
|
|
|
|
|
|
|
|
Common stock, no par value; shares authorized
250,000,000; shares issued and
outstanding 132,858,736 and 154,810,156,
respectively |
|
|
203,211 |
|
|
|
211,683 |
|
Deficit accumulated during the development stage |
|
|
(179,877 |
) |
|
|
(191,865 |
) |
|
|
|
|
|
|
|
Total shareholders equity |
|
|
23,334 |
|
|
|
19,818 |
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
26,217 |
|
|
$ |
21,955 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
3
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 24, 1989 |
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
(Inception) to |
|
|
|
March 31, |
|
|
March 31, |
|
|
March 31, |
|
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2009 |
|
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and rentals |
|
$ |
103 |
|
|
$ |
58 |
|
|
$ |
139 |
|
|
$ |
113 |
|
|
$ |
1,692 |
|
Research and development agreements |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,105 |
|
Grants |
|
|
99 |
|
|
|
|
|
|
|
234 |
|
|
|
|
|
|
|
9,657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
202 |
|
|
|
58 |
|
|
|
373 |
|
|
|
113 |
|
|
|
13,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COSTS AND EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales and rentals |
|
|
30 |
|
|
|
25 |
|
|
|
31 |
|
|
|
47 |
|
|
|
697 |
|
Cost of product sales and rentals
- -
provision for obsolete and excess inventory |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,239 |
|
Research and development |
|
|
4,032 |
|
|
|
2,785 |
|
|
|
11,800 |
|
|
|
8,340 |
|
|
|
145,159 |
|
Selling, general and administrative |
|
|
1,429 |
|
|
|
1,260 |
|
|
|
4,768 |
|
|
|
3,909 |
|
|
|
67,617 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
5,491 |
|
|
|
4,070 |
|
|
|
16,599 |
|
|
|
12,296 |
|
|
|
215,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
|
(5,289 |
) |
|
|
(4,012 |
) |
|
|
(16,226 |
) |
|
|
(12,183 |
) |
|
|
(202,258 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,249 |
|
Interest income |
|
|
266 |
|
|
|
57 |
|
|
|
1,017 |
|
|
|
253 |
|
|
|
10,521 |
|
Interest expense |
|
|
(25 |
) |
|
|
(17 |
) |
|
|
(61 |
) |
|
|
(58 |
) |
|
|
(409 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
241 |
|
|
|
40 |
|
|
|
956 |
|
|
|
195 |
|
|
|
11,361 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(5,048 |
) |
|
$ |
(3,972 |
) |
|
$ |
(15,270 |
) |
|
$ |
(11,988 |
) |
|
$ |
(190,897 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPUTATION OF NET LOSS PER SHARE
APPLICABLE TO COMMON SHARES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(5,048 |
) |
|
$ |
(3,972 |
) |
|
$ |
(15,270 |
) |
|
$ |
(11,988 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS PER SHARE
(Basic and Diluted) |
|
$ |
(.04 |
) |
|
$ |
(.03 |
) |
|
$ |
(.12 |
) |
|
$ |
(.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
outstanding (Basic and Diluted) |
|
|
132,719 |
|
|
|
146,614 |
|
|
|
127,916 |
|
|
|
137,932 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
4
AASTROM BIOSCIENCES, INC.
(a clinical development stage company)
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 24, 1989 |
|
|
|
Nine months ended |
|
|
(Inception) to |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2008 |
|
|
2009 |
|
|
2009 |
|
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,270 |
) |
|
$ |
(11,988 |
) |
|
$ |
(190,897 |
) |
Adjustments to reconcile net loss to net cash used for
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
551 |
|
|
|
522 |
|
|
|
5,818 |
|
Loss on property held for resale |
|
|
|
|
|
|
|
|
|
|
110 |
|
Amortization of discounts and premiums on investments |
|
|
(362 |
) |
|
|
(30 |
) |
|
|
(1,704 |
) |
Stock compensation expense |
|
|
1,635 |
|
|
|
1,129 |
|
|
|
8,156 |
|
Inventory write downs and reserves |
|
|
|
|
|
|
|
|
|
|
2,239 |
|
Stock issued pursuant to license agreement |
|
|
|
|
|
|
|
|
|
|
3,300 |
|
Provision for losses on accounts receivable |
|
|
|
|
|
|
|
|
|
|
204 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Receivables |
|
|
15 |
|
|
|
(236 |
) |
|
|
(503 |
) |
Inventories |
|
|
8 |
|
|
|
|
|
|
|
(2,335 |
) |
Other current assets |
|
|
(278 |
) |
|
|
432 |
|
|
|
(594 |
) |
Accounts payable and accrued expenses |
|
|
(793 |
) |
|
|
(23 |
) |
|
|
827 |
|
Accrued employee benefits |
|
|
(821 |
) |
|
|
(392 |
) |
|
|
355 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used for operating activities |
|
|
(15,315 |
) |
|
|
(10,586 |
) |
|
|
(175,024 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Organizational costs |
|
|
|
|
|
|
|
|
|
|
(73 |
) |
Purchase of short-term investments |
|
|
(24,752 |
) |
|
|
|
|
|
|
(212,041 |
) |
Maturities of short-term investments |
|
|
40,000 |
|
|
|
6,000 |
|
|
|
213,745 |
|
Property and equipment purchases |
|
|
(201 |
) |
|
|
(34 |
) |
|
|
(5,760 |
) |
Proceeds from sale of property held for resale |
|
|
|
|
|
|
|
|
|
|
400 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used for) investing activities |
|
|
15,047 |
|
|
|
5,966 |
|
|
|
(3,729 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of preferred stock |
|
|
|
|
|
|
|
|
|
|
51,647 |
|
Net proceeds from issuance of common stock |
|
|
13,612 |
|
|
|
7,343 |
|
|
|
144,154 |
|
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 |
|
|
179 |
|
|
|
192 |
|
|
|
(344 |
) |
Proceeds from long-term debt |
|
|
|
|
|
|
|
|
|
|
751 |
|
Principal payments under debt obligations |
|
|
(249 |
) |
|
|
(331 |
) |
|
|
(1,861 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
13,542 |
|
|
|
7,204 |
|
|
|
197,829 |
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
13,274 |
|
|
|
2,584 |
|
|
|
19,076 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT
BEGINNING OF PERIOD |
|
|
13,439 |
|
|
|
16,492 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT
END OF PERIOD |
|
$ |
26,713 |
|
|
$ |
19,076 |
|
|
$ |
19,076 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
5
AASTROM BIOSCIENCES, INC.
(A clinical development stage company)
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
1. Organization
Aastrom Biosciences, Inc. was incorporated in March 1989 (Inception), began employee-based
operations in 1991, and is in the development stage. The Company operates its business in one
reportable segment research and product development involving the development of autologous cell
products for use in regenerative medicine.
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 for 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. Management believes, based on its current
projections of the Companys cash utilization (which is expected
to approximate between $1.2 - $1.3
million per month) and taking into consideration the $1.3 million of additional cash raised in
April 2009 (as described in Note 5), available cash and cash equivalents on hand as of April 30,
2009 (which equaled approximately $19.5 million) are adequate to finance the Companys planned
operations at least until March 31, 2010. However, the Company will need to raise a significant
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, fulfillment of the
requirements for marketing authorization from regulatory bodies in the U.S., EU and other
countries, the liquidity and market volatility of the Companys equity securities, regulatory and
manufacturing requirements and uncertainties, technological developments by competitors, the U.S.
economic conditions regarding the availability of investment capital 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 in accordance 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 three and nine months ended March 31,
2009 are not necessarily indicative of the results to be expected for the full year or for any
other period.
6
These financial statements should be read in conjunction with the audited financial statements
and the notes thereto included in the Companys 2008 Annual Report on Form 10-K for the year ended
June 30, 2008, as filed with the Securities and Exchange Commission.
The consolidated financial statements include the accounts of Aastrom and its wholly-owned
subsidiaries, Aastrom Biosciences GmbH, located in Berlin, Germany, Aastrom Biosciences, Ltd.,
located in Dublin, Ireland and Aastrom Biosciences, 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.
In June 2007, the Financial Accounting Standards Board (FASB) ratified Emerging Issues Task
Force (EITF) 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services Received
for Use in Future Research and Development Activities (EITF 07-3). EITF 07-3 requires that
nonrefundable advance payments for goods or services that will be used or rendered for future
research and development activities be deferred and capitalized and recognized as an expense as the
goods are delivered or the related services are performed. The Companys adoption of EITF 07-3 on
July 1, 2008, did not have a material impact on its consolidated financial position and results of
operations.
3. Fair Value Measurements
Effective July 1, 2008, the Company adopted Statement of Financial Accounting Standards No.
157, Fair Value Measurements (SFAS 157) for assets and liabilities measured at fair value on a
recurring basis. In addition to expanding the disclosures surrounding fair value measurements,
SFAS 157 clarifies that fair value represents the amount that would be received to sell 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, SFAS 157 establishes 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. |
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, 2009, the Company had $19.1 million invested in money market funds, which is
included within the Cash and cash equivalents line on the balance sheet. Because there are
quoted prices in an active market for shares of this money market fund, the Company considers its
fair value measure of this investment to be based on Level 1 inputs. The adoption of SFAS 157 did
not change the way in which the Company records this investment at fair value.
7
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. Options granted under these plans expire no later than ten years from
the date of grant, and other than those granted to non-employee directors, generally become
exercisable over a four-year period, under a graded-vesting methodology, following the date of
grant.
Service-Based Options
During the nine months ended March 31, 2009, the Company granted 3,990,000 service-based
options to purchase common stock. These were granted with exercise prices equal to the fair value
of the Companys stock at the grant date, vest over four years (other than 3,545,000 of options
granted in October 2008 that vest over 3 years) and have lives of 10 years. Non-employee director
options vest over one year. The weighted average grant-date fair value of service-based options
granted under the Companys Option Plans during the nine months ended March 31, 2008 and 2009 was
$0.66 and $0.39, respectively.
The net compensation costs recorded for the service-based stock options related to employees
and directors were approximately $352,000 and $1,060,000 for the three and nine months ended March
31, 2009, respectively, compared to $487,000 and $1,541,000 for the same periods in fiscal year
2008.
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, |
|
|
2008 |
|
2009 |
Stock Option Plans: |
|
|
|
|
|
|
|
|
Expected dividend rate |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
61 |
% |
|
|
73 |
% |
Risk free interest rate |
|
|
4.2 |
% |
|
|
2.1 |
% |
Estimated forfeiture rate |
|
|
10 |
% |
|
|
10 |
% |
Expected life (years) |
|
|
6.6 |
|
|
|
6.6 |
|
8
The following table summarizes the activity for service-based stock options for the indicated
periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted Average |
|
|
Aggregate |
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
Options |
|
|
Exercise Price |
|
|
Contractual Term |
|
|
Value |
|
Outstanding at June 30, 2008 |
|
|
8,535,181 |
|
|
$ |
1.31 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
3,990,000 |
|
|
$ |
0.39 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(1,430,577 |
) |
|
$ |
1.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2009 |
|
|
11,094,604 |
|
|
$ |
0.99 |
|
|
|
8.0 |
|
|
$ |
27,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March 31, 2009 |
|
|
4,790,714 |
|
|
$ |
1.34 |
|
|
|
6.8 |
|
|
$ |
6,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2009, there was approximately $1,152,000 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 1.4 years.
Performance-Based Stock Options
There were no grants of performance-based stock options for the nine months ended March 31,
2009.
The vesting of performance options is dependent on both of the following conditions occurring:
(i) the passage of a certain amount of time subsequent to the grant date and (ii) meeting certain
performance conditions which relate to our progress in our clinical trial programs. The Board of
Directors will determine if the performance conditions have been met. Stock-based compensation
expense for these options will be recorded when the Company believes that the vesting of these
options is probable based on the progress of its clinical trial programs and other relevant
factors.
For the performance-based options outstanding at March 31, 2009, there are two tranches of
performance-based options that vest upon the satisfaction of performance conditions, all of which
vest based on progress toward clinical trial or product successes within a certain timeframe.
The first tranche would vest if performance conditions are met by June 2011; and, the second
tranche would vest if performance conditions are met by June 2012. Each tranche of options is
forfeited if its performance conditions are not met by the required timeframe, and vesting for
any tranche of options is not dependent on the vesting of the other tranches of options.
For the nine months ended March 31, 2009, 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.
9
The following table summarizes the activity for performance-based stock options for the
indicated period:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Exercise |
|
|
Remaining |
|
|
Aggregate |
|
Options |
|
Shares |
|
|
Price |
|
|
Contractual Term |
|
|
Intrinsic Value |
|
Outstanding at June 30, 2008 |
|
|
1,287,868 |
|
|
$ |
1.49 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(406,534 |
) |
|
$ |
1.53 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2009 |
|
|
881,334 |
|
|
$ |
1.47 |
|
|
|
7.7 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate estimated fair value of these awards that are outstanding as of March 31, 2009
is approximately $876,000.
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 $21,000 and $69,000 for the three and nine months ended March
31, 2009, respectively, compared to $41,000 and $94,000 for the same periods in fiscal year 2009.
A summary of the Companys restricted stock activity for the nine months ended March 31, 2009
is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
Grant Date Fair |
|
Non-vested Restricted Shares |
|
Shares |
|
|
Value |
|
Non-vested at June 30, 2008 |
|
|
88,825 |
|
|
$ |
1.68 |
|
Granted |
|
|
155,200 |
|
|
$ |
0.29 |
|
Vested |
|
|
(94,450 |
) |
|
$ |
0.94 |
|
Forfeited |
|
|
(10,050 |
) |
|
$ |
1.85 |
|
|
|
|
|
|
|
|
|
Non-vested at March 31, 2009 |
|
|
139,525 |
|
|
$ |
0.62 |
|
|
|
|
|
|
|
|
|
As of March 31, 2009, there was approximately $26,000 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 0.5 years.
10
5. Shareholders Equity
In October 2008, the Company entered into a $15 million common stock purchase agreement with
Fusion Capital Fund II, LLC (Fusion Capital), an Illinois limited liability company. On April
29, 2009, Fusion Capital purchased all of the remaining registered shares available under the
common stock purchase agreement. In accordance with NASDAQ Capital Market rules, Aastrom did not
seek shareholder approval to issue more than 19.99% of its outstanding common stock shares to
Fusion Capital.
Concurrent to entering into the common stock purchase agreement, the Company entered into a
registration rights agreement with Fusion Capital. Under the registration rights agreement,
Aastrom agreed to file a registration statement related to the transaction with the U.S. Securities
& Exchange Commission (SEC) covering the shares that have been issued or may be issued to Fusion
Capital under the common stock purchase agreement. The SEC declared this registration statement to
be effective on November 26, 2008. The Company had the right over a 25-month period (beginning on
the date the SEC declared the registration statement to be effective) to sell shares of Aastrom
common stock to Fusion Capital from time to time in amounts between $60,000 and $2 million,
depending on certain conditions as set forth in the agreement, up to an aggregate of $15 million.
The number of shares that could be issued to Fusion Capital during each sale was determined based
on a stock price (Purchase Price) that was the lower of the (a) the lowest sale price of common
stock on the purchase date or (b) the arithmetic average of the three (3) lowest closing sale
prices of common stock during the twelve (12) consecutive business days (ten (10) days in certain
circumstances) ending on the business day immediately preceding the purchase date (to be
appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or
other similar transaction). The Company controlled the timing and amount of the sales of shares to
Fusion Capital.
Pursuant to the common stock purchase agreement with Fusion Capital, there were certain events
of default which, if such an event were to occur, would eliminate the obligation of Fusion Capital
to purchase shares from the Company. Such events included, but were not limited to, (i) shares of
the Companys common stock not being listed on any one of several stock exchanges outlined in the
agreement and (ii) a material adverse change in the Companys business or operations. In
addition, Fusion Capital did not have the obligation to purchase any shares of the Companys common
stock on any business day that the Purchase Price of the Companys common stock was below $0.10.
The common stock purchase agreement could be terminated by Aastrom at any time at the Companys
discretion without any cost to Aastrom. There were no negative covenants, restrictions on future
fundings, penalties or liquidated damages in the agreement. The proceeds received by the Company
under the common stock purchase agreement will be used to conduct operations and continue to
conduct the Companys clinical development programs.
11
In consideration for entering into the agreement, upon execution of the common stock purchase
agreement in October 2008, Aastrom issued to Fusion Capital 1,936,317 shares of the Companys
common stock as a commitment fee. Also, Aastrom issued to Fusion
Capital an additional 1,113,835
shares as a pro rata commitment fee.
Through March 31, 2009, 21,783,142 shares of the Companys common stock (including 2,887,689
shares related to its commitment fee) were issued to Fusion Capital for net proceeds of $7,335,000.
During April 2009, 3,959,674 shares of the Companys common stock (including 162,463 shares
related to its commitment fee) were issued to Fusion Capital for net proceeds of $1,259,000. On
April 29, 2009, the Company issued the final registered shares available under the common stock
purchase agreement with Fusion Capital.
In October 2008, warrants to purchase up to 1,838,843 shares of common stock pursuant to
previous warrant agreements expired unexercised.
On April 5, 2009, warrants to purchase up to 2,400,000 shares of common stock pursuant to
previous warrant agreements expired unexercised.
6. Net Loss Per Common Share
Net loss per common share is computed using the weighted-average number of common shares
outstanding during the period. Common equivalent shares, consisting of options, warrants for the
purchase of common stock and nonvested 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 each of the three and nine months ended March 31, 2008 and 2009 is approximately
20,976,000 and 20,436,516, respectively.
12
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Overview of Aastrom
We are a regenerative medicine company (a medical area that focuses on developing therapies
that regenerate damaged or diseased tissues or organs) that incorporated in 1989 and focuses on the
clinical development of autologous cell products (cells collected from a patient and returned to
that same patient) for the repair or regeneration of multiple human tissues, based on our
proprietary Tissue Repair Cell (TRC) technology. Our preclinical and clinical product development
programs utilize patient-derived bone marrow stem and early progenitor cell populations, and are
being investigated for their ability to aid in the regeneration of tissues such as cardiac,
vascular, bone and neural. TRC-based products have been used in over 325 patients, and are
currently in the following stages of development:
|
|
|
Cardiac regeneration Cardiac Repair Cells (CRCs): |
|
o |
|
Dilated cardiomyopathy (DCM) (severe chronic disease of the heart): |
|
§ |
|
U.S.: IMPACT-DCM Phase II clinical trial began treating patients in November 2008;
to date, 14 patients enrolled at four clinical sites (The Methodist Hospital,
Houston, TX, Baylor University Medical Center, Dallas, TX, The University of Utah
School of Medicine, Salt Lake City, UT, and Cleveland Clinic Heart & Vascular
Institute, Cleveland, OH); initiation of one other clinical site is in progress;
Orphan Drug Designation from the FDA for use in treatment of DCM; and, on May 5,
2009, preliminary findings from the IMPACT-DCM trial were presented at the
International Society for Cellular Therapy annual meeting by the
studys National Lead
Investigator |
|
|
§ |
|
Germany: Encouraging data reported April 2008 from compassionate use treatment in
two patients; one patient later died of natural causes unrelated to cell therapy; the
second patient maintained a left ventricular ejection fraction (LVEF) of 45% at
7-months follow-up (baseline 25-30%) |
|
|
|
Vascular regeneration Vascular Repair Cells (VRCs): |
|
o |
|
Critical limb ischemia (CLI): |
|
§ |
|
U.S.: RESTORE-CLI Phase IIb clinical trial has enrolled 60 patients to date;
interim analysis of 12-month data for the first 30 patients expected to occur during
the 4th quarter of calendar year 2009; patient enrollment continues |
|
|
§ |
|
Germany: Phase I/II investigator-sponsored clinical trial completed enrollment and
patient follow-up ongoing; positive interim data reported October 2007; investigator
report of final data expected during the second quarter of calendar year 2009 |
|
|
|
Bone regeneration Bone Repair Cells (BRCs): |
|
o |
|
Osteonecrosis of the femoral head: |
|
§ |
|
U.S.: ON-CORE Phase III clinical trial active; not enrolling additional patients;
Orphan Drug Designation from the FDA for use in treatment of osteonecrosis of the
femoral head |
|
|
§ |
|
Spain: 9 hips (7 patients) currently treated of 10 planned; 24 month follow-up for
all patients |
|
|
§ |
|
Germany: Encouraging data reported October 2007 from compassionate use treatment
cases; follow-up ongoing |
13
|
§ |
|
U.S.: Final clinical study report issued in December 2008; TRC product showed an
excellent safety profile and the efficacy data indicated a high non-union healing
rate, with bridging callus formation rates reported in over 90% of patients 12 months
post-surgery compared to 50% historically |
|
|
§ |
|
Spain: Final 24-month follow-up complete for 10-patient investigator-sponsored Phase II clinical trial; the final investigator report indicates that 7 of 10 cases
resulted in healing at 24 months |
|
|
|
Neural regeneration Neural Repair Cells (NRCs): |
|
§ |
|
Plans for clinical program on hold |
Our platform TRC technology is based on 1) autologous cell products which are a unique cell
mixture containing large numbers of stem and early progenitor cells produced outside of the body
from a small amount of bone marrow taken from the patient, and 2) the ability to produce these
products in an automated process that meets Good Manufacturing Practice (GMP) requirements.
We have developed a manufacturing system to produce human cells for clinical use. This
automated cell manufacturing system enables the single-pass perfusion cell culture process.
Single-pass perfusion is our patented manufacturing technology for growing large numbers of human
cells. The cellular components of TRC-based products include adult stem and early progenitor cell
populations, which are capable of forming tissues such as cardiac, vascular, bone, neural, and the
hematopoietic and immune system.
All TRC-based products are produced using our cell manufacturing system in centralized
manufacturing facilities. We have one manufacturing site in the U.S. located in Ann Arbor, MI, and
three contract facilities in the EU located in Stuttgart, Germany (Fraunhofer Institute for
Interfacial Engineering and Biotechnology), Bad Oeynhausen, Germany (Institute of Laboratory and
Transfusion Medicine at the Heart Center) and Barcelona, Spain (Tissue and Cell Therapy Center at
the Blood and Tissue Bank).
Since our inception, we have been in the development stage and engaged in research and product
development, conducted principally on our own behalf. Our initial business plan was to pursue our
targeted markets by commercializing our cell manufacturing system and supplies. Since 2004 we have
phased out our marketing efforts promoting the cell manufacturing system as a commercial product.
Currently, we have minimal product sales consisting of manufacturing supplies to academic
collaborators in the U.S. and cell-based products to EU-based physicians.
Our current focus is on utilizing our TRC technology to produce autologous cell-based products
for use in regenerative medicine applications. At such time as we satisfy applicable regulatory
approval requirements, we expect the sales of our TRC-based products to constitute nearly all of
our product sales revenues.
We do not expect to generate positive cash flows from our consolidated operations for at least
the next several years and then only if significant TRC-based cell product sales commence. Until
that time, we expect that our revenue sources from our current activities will consist of only
minor sales of our cell products and manufacturing supplies to our academic collaborators, grant
revenue, research funding and potential licensing fees or other financial support from potential
future corporate collaborators.
14
In May 2008, we reprioritized our clinical development programs to focus primarily on
cardiovascular applications, including dilated cardiomyopathy and critical limb ischemia. We have
discontinued further patient enrollment into our Phase III ON-CORE (osteonecrosis) bone
regeneration trial. We do not anticipate initiating new clinical bone activity, reactivating the
Phase III ON-CORE trial or initiating formal clinical trials in the neural area without additional
financial resources. While the decision to reprioritize was driven by economic factors, the
clinical programs were prioritized based on anticipated time to market and the perceived relative
clinical and market potential. We are also exploring the possibility of entering into
complementary regenerative medicine business activities, whether through acquisition or otherwise.
In addition to reprioritizing our development and clinical programs, we also made reductions in our
staff and reduced our overhead expenses.
We expect that we will need to raise significant additional funds or pursue strategic
transactions or other strategic alternatives in order to complete our product development programs,
complete clinical trials needed to market our products, and commercialize our products. To date,
we have financed our operations primarily through public and private sales of our equity
securities, and we expect to continue obtaining required capital in a similar manner. As a
development stage company, we have never been profitable and do not anticipate having net income
unless and until significant product sales commence. With respect to our current activities, this
is not likely to occur until we obtain significant additional funding, complete the required
clinical trials for regulatory
approvals, and receive the necessary approvals to market our products. Through March 31, 2009, we
have accumulated a net loss of approximately $191 million. We cannot provide any assurance that we
will be able to achieve profitability on a sustained basis, if at all, obtain the required funding,
obtain the required regulatory approvals, or complete additional corporate partnering or
acquisition transactions.
Clinical Development
Currently, our clinical development programs are focused primarily on the utilization of our
TRC technology for cardiac and vascular regeneration. An improved formulation for storage of our
TRC-based cell product has been developed to extend the shelf-life of our product. The extended
shelf-life provides additional flexibility in transport of the product and in scheduling of patient
administration. The extended shelf-life product has been qualified and implemented at our
centralized manufacturing sites in the U.S. and EU. It is used for all cardiac and vascular
regeneration clinical trials in the U.S. and is available for supply to all active EU treatment
sites.
In May 2008, we 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. We have discontinued further patient enrollment into
our Phase III ON-CORE (osteonecrosis) bone regeneration trial. We do not anticipate initiating new
clinical bone activity, reactivating the Phase III ON-CORE trial or initiating formal clinical
trials in the neural area without additional financial resources. While the decision to
reprioritize was driven by economic factors, the clinical programs were prioritized based on
anticipated time to market and the perceived relative clinical and market potential.
15
The preclinical data for our TRC-based products have shown that the large numbers of the stem
and early progenitor cells obtained through application of our TRC technology can develop into a
variety of tissues including blood, bone, vascular and fat, as well as the potential to form
tissues characteristic of certain internal organs. We have demonstrated in the laboratory that
TRC-based products can differentiate into both endothelial (blood vessel) and osteoblast (bone
cell) lineages. Based on these preclinical observations, clinical trials have been initiated in
the U.S. and European Union (EU) for cardiac tissue regeneration in patients with dilated
cardiomyopathy, for vascular tissue regeneration in patients with critical limb ischemia and for
bone regeneration in patients with osteonecrosis of the femoral head and severe long bone
fractures.
The preliminary results of our current clinical trials may not be indicative of results that
will be 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. See Risk Factors.
Clinical Trials Summary
Cardiac Regeneration
Dilated Cardiomyopathy
To date, 14 patients have been enrolled in our U.S. Phase II clinical trial (called
IMPACT-DCM) at the first four clinical sites (The Methodist Hospital, Houston, TX, Baylor
University Medical Center, Dallas, TX, The University of Utah School of Medicine, Salt Lake City,
UT, and Cleveland Clinic Heart & Vascular Institute, Cleveland, OH). In November 2008, the first
patient was treated in the 40-patient IMPACT-DCM trial to evaluate the use of Cardiac Repair Cells
(CRCs), a mixture of stem and progenitor cells derived from a patients own bone marrow, for the
treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure. The U.S. Food &
Drug Administration (FDA) approved our Investigational New Drug
(IND) application in May 2008.
This randomized, controlled, prospective, open-label, Phase II study seeks to enroll 20 patients
with ischemic DCM and 20 patients with non-ischemic DCM at up to 5 clinical sites in the U.S. One
additional clinical site has been identified and is completing the various steps necessary to begin
patient enrollment, including clinical trial agreements, Investigational Review Board (IRB) review
and approval, and clinical site training. CRCs, manufactured using Aastroms TRC technology,
received an Orphan Drug Designation from the FDA for the treatment of DCM in February 2007.
16
On May 5, 2009, initial patient data from the IMPACT-DCM trial were presented at the
International Society for Cellular Therapy annual meeting by the
studys National Lead Investigator, Dr. Amit N. Patel.
Participants in the IMPACT-DCM clinical trial 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. All patients
in each group will receive standard medical care and approximately 75% of the patients in each
group will be treated with CRCs through direct injection into the heart muscle during open heart
surgery. While the primary objective of this study is to assess the safety of CRCs in patients
with DCM, efficacy measures including left ventricular ejection fraction and other cardiac function
parameters as well as heart failure stage will be monitored. Patients will be followed for 12
months post treatment.
On March 3, 2009, the FDA informed us that it had completed its review of our response to the
issue cited in the FDA clinical hold letter and that the clinical hold had been lifted from the
IMPACT-DCM clinical trial, therefore, patient enrollment could resume. We had previously reported
on February 2, 2009 that one patient enrolled in the IMPACT-DCM clinical trial experienced a
serious adverse event associated with anesthesia management during treatment at one of the clinical
sites. Notwithstanding the hold, the FDA authorized us to proceed with the CRC treatment for one
patient previously enrolled in the IMPACT-DCM clinical trial. This patient was treated at the end
of January 2009. In addition, follow-up monitoring of patients who had previously been treated in
the IMPACT-DCM trial continued in accordance with the study protocol during the clinical hold
period.
In April 2008, we reported data from two compassionate use patients treated in Germany with
our autologous stem cell therapy for DCM. A cardiothoracic surgeon experienced with cell therapy
at the University Hospital in Dusseldorf, Germany performed the first human application of our CRC
product through direct injection into the heart muscle during open heart surgery for these two
patients in late 2007. The data from these two critically ill patients upon discharge from the
surgical center was encouraging. Per typical treatment practices in Germany, once these patients
were released from the surgical center, they were followed by regional rehabilitation hospitals or
local physicians. Patient #1 had an LVEF of approximately 10% (the percentage of blood pumped out
of the heart with each contraction) prior to the CRC treatment in November 2007. Over the course
of two months, this patients LVEF improved to 25-30% and clinical improvement of his heart failure
stage was noted. As reported to us by the surgeon, during his stay at a rehabilitation hospital,
this critically ill patient refused all further medical treatment and discharged himself from the
hospital against medical advice. This patients subsequent death due to natural causes was
unrelated to the cell therapy treatment. Patient #2 had an LVEF of 25-30% prior to being treated
with CRCs in December 2007. Upon discharge from the surgical center in February 2008 her LVEF had
improved to 45%. In September 2008, at a 7 month follow-up visit with the treating surgeon, this
patients LVEF was again measured at 45% and the patient reported further improvement in her heart
failure symptoms. These EU compassionate use treatments provided supporting information considered
critical to the success of the U.S. Phase II IMPACT-DCM IND application.
17
DCM is a chronic cardiac disease that leads to enlargement of the heart and is associated with
reduced pump function to the point that blood circulation is impaired. Typically patients with DCM
present with symptoms of congestive heart failure, including limitations in their physical activity
and shortness of breath. DCM often represents the end stage of chronic ischemic heart disease in
patients who have experienced multiple heart attacks. 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 report estimates of up to 150,000.
Vascular Tissue Regeneration
Critical Limb Ischemia
Based on our laboratory observations that TRC-based products have the ability to form small
blood vessels in vitro and results from third party trials involving the use of bone marrow cells
for peripheral vascular disease, we are conducting trials to evaluate the safety and efficacy of
Vascular Repair Cells (VRCs) based on TRC technology in the treatment of diabetics with open foot
wounds and patients diagnosed with critical limb ischemia (CLI).
In October 2008, the first 30 patients (treatment and placebo control) completed enrollment in
our RESTORE-CLI trial, a U.S. Phase IIb prospective, controlled, randomized, double-blind,
multi-center clinical trial to treat patients suffering from CLI, the end stage of peripheral
arterial disease. This study is allowed to enroll up to 150 patients at up to 30 sites. Patients
are randomized
into two patient groups (treatment or placebo control), to evaluate the safety and efficacy of VRCs
in the treatment of CLI. To date, 60 patients have been enrolled in the RESTORE-CLI trial and 21
clinical sites are open for patient enrollment. Our website will be updated as additional sites
are open for patient enrollment. Patients will be followed for a period of twelve months
post-treatment. In addition to assessing the safety of the VRCs, secondary objectives include
assessing major amputation rates, level of amputation, wound healing and blood flow in the affected
limbs, patient quality of life, pain scores and analgesic use. During the 4th quarter
of calendar year 2009, we expect to unblind and analyze the clinical data from the first 30
patients enrolled in the study.
In October 2007, positive interim results from the first 13 patients treated in Germany in a
30-patient multi-arm Phase I/II single-center clinical trial to evaluate the safety of VRCs and
unexpanded bone marrow cells in the treatment of chronic diabetic foot wounds associated with CLI
were reported by an investigator from the Heart & Diabetes Center located in Bad Oeynhausen,
Germany at the 2nd Congress of the German Society for Stem Cell Research in Würzburg, Germany.
Results reflect treatment experience from: four diabetic patients with ischemia-related chronic
tissue ulcers who were treated with our VRCs; seven patients who were treated with normal
unexpanded marrow cells; and two standard of care patients who did not receive cells. All patients
received standard wound care as described by the American Diabetes Association. Twelve months
post-treatment, all patients in the interim analysis who were treated with VRCs reported no major
amputations, no cell-related adverse events, and healing of all open wounds. Of the seven patients
treated with unexpanded bone marrow cells, five reported results similar to the VRC-treated
patients 12 months post-treatment, one reported similar results to the VRC-treated patients 18
months post-treatment, and one patient underwent a major amputation. For the two standard of care
patients who only received wound care (no cells), one patient received a major amputation and one
patient experienced no improvement in wound healing after 12 months. Patient follow-up has been
completed and final data is expected to be reported by the investigator during the second quarter
of calendar year 2009.
18
Bone Regeneration
Osteonecrosis of the Femoral Head
In May 2008, we reprioritized our clinical development programs to primarily focus on
cardiovascular applications. We have discontinued further patient enrollment into our U.S. Phase
III ON-CORE (osteonecrosis) bone regeneration trial. We do not anticipate new clinical bone
activity or reactivating the Phase III ON-CORE trial without additional financial resources. While
the decision to reprioritize was driven by economic factors, the clinical programs were prioritized
based on anticipated time to market and the perceived relative clinical and market potential.
In May 2007, the FDA approved our Investigational New Drug (IND) application which allowed us
to proceed with our ON-CORE trial, a U.S. Phase III clinical trial, to use our Bone Repair Cells
(BRCs) based on our TRC technology in the treatment of osteonecrosis (also known as avascular
necrosis) of the femoral head. While the 7 treated patients will continue to be monitored for the
full 24-month follow-up period, no additional patients are being enrolled at this time. Our
website will be updated if we resume patient enrollment in this trial. In March 2006, we received
an Orphan Drug Designation from the FDA to use our BRCs in the treatment of osteonecrosis of the
femoral head.
In October 2007, early clinical results from 4 compassionate use patients were presented by an
investigator from the Orthopedic Institute, König-Ludwig-Haus, University of Würzburg, Germany,
involving the first use of our Bone Repair Cells (BRCs) to treat patients suffering from
osteonecrosis of the femoral head. Osteonecrosis of the femoral head involves the death of cells in
the bone and marrow within the femur head and in many cases leads to total hip replacement. After
6 months of follow-up all patients tolerated the procedure well. Three patients reported a
reduction in hip pain, there were no signs of disease progression for any of the four patients (as
determined by MRI and X-ray) and all were back to work within 6 months after treatment. In
addition, no cell-related adverse events were reported and none of these patients have required hip
replacement surgery. Follow-up for these compassionate use patients is ongoing.
In January 2007, we opened patient enrollment and treatment in a clinical trial in Spain
utilizing BRCs for the treatment of osteonecrosis of the femoral head. The trial protocol was
approved by the Spanish Drug Agency (AEMPS) and Centro Medico Teknons (Teknon) Ethics Committee
for our Investigational Medicinal Product Dossier (IMPD), and is being conducted at Teknon located
in Barcelona, Spain. Patient recruitment is ongoing with 9 hips (7 patients) currently treated of
10 planned.. All patients will be followed for 24 months post-treatment.
19
Other Bone
In December 2008, the final Aastrom clinical study report from our U.S. Phase I/II clinical
trial for the treatment of severe long bone non-union fractures was completed. This trial
demonstrated that the TRC product had an excellent safety profile. The overall number of adverse
events reported was low in comparison to historical data, and no adverse events were considered
related to the TRC product. The efficacy data indicated a high non-union fracture healing rate,
with bridging callus formation rates in over 90% of patients 12 months post-surgery compared to 50%
historically.
An initial 5 patient bone regeneration (post-fracture) study was conducted at three centers in
Spain under Ethical Committee approval; positive results were disclosed in May 2005. Following
this trial, a physician-sponsored 10 patient Phase II non-union fracture trial was initiated. The
Phase II study has completed BRC treatment of all 10 patients. The final investigator report
indicates that 7 of 10 cases resulted in healing at 24 months with no adverse events related to
bone marrow aspiration or TRC implementation.
The Phase I/II spine fusion clinical trial at William Beaumont Hospital, Royal Oak, MI has
been closed and no further patients will be enrolled. While the 2 patients who were treated in
this trial did not experience any cell-related adverse events and there were no safety issues,
there was no conclusive evidence of efficacy with the current
formulation for ectopic bone formation in this indication.
Neural Regeneration
In May 2008, we reprioritized our clinical development programs to primarily focus on
cardiovascular applications. We do not anticipate initiating formal clinical trials in the neural
area using our proprietary Neural Repair Cells (NRCs) without additional financial resources.
While the decision to reprioritize was driven by economic factors, the clinical programs were
prioritized based on anticipated time to market and the perceived relative clinical and market
potential.
Additional Activity
In certain non-U.S. regions, autologous cells, such as our TRC-based products, do not require
a marketing authorization for commercial distribution. This enables us to gain product use
experience and refine our clinical development strategies through compassionate use and standard
patient treatment in countries where it is allowed and where both the patient and the physician see
a potential benefit from using TRC-based products.
Through limited commercial use of TRC-based products, we are also able to obtain a privileged
regulatory position in some regions. In the EU, the Advanced Therapies and Medicinal Products
(ATMP) regulation went into effect January 1, 2009 requiring cell products such as ours to obtain a
marketing authorization from the European Medicines Agency (EMEA) before they can be marketed in EU
member states. However, the ATMP includes a grandfathering provision that allows products on the
market in one or more EU member states on December 31, 2008 to remain on the market in those EU
member states for a period of four years before EMEA market authorization must be obtained. With
the activities completed to date in Germany, we believe TRC-based products meet the requirements
for the ATMP transition period in this member state.
20
In any event, we do not anticipate generating significant sales in any geographic region until
we have sufficient evidence of clinical safety and efficacy to ensure marketplace acceptance and
product reimbursement and to justify the investment in manufacturing, sales and marketing
infrastructure. However, we are currently generating limited, nominal sales of TRC-based products
and expect to continue this level of activity. As a result of these limited, commercial treatment
activities, it is possible that we, or third parties, may make case studies and other data
generated outside of a clinical trial program available on websites, in publications or in
presentations. Such data should be considered anecdotal; it is not intended to represent evidence
of clinical efficacy or to suggest that any future clinical trials will demonstrate that TRC-based
products are effective in any specific medical application.
Results of Operations
Total revenues, consisting of grant revenues and product sales, for the quarter and nine
months ended March 31, 2009 were $58,000 and $113,000, respectively, compared to $202,000 and
$373,000, respectively, for the same periods in fiscal year 2008. Product sales for the quarter
and nine months ended March 31, 2009 were $58,000 and $113,000, respectively, compared to $103,000
and $139,000 for the same periods in fiscal 2008. No grant revenues were recorded for the
quarter and nine months ended March 31, 2009 as there were no active grants with the National
Institutes of Health. Grant revenues for the quarter and nine months ended March 31, 2008 were
$99,000 and $234,000, respectively. Grant revenues may vary in any period based on timing of grant
awards, grant-funded activities, level of grant funding and number of grant awards received.
Total costs and expenses decreased to $4,070,000 for the quarter ended March 31, 2009,
compared to $5,491,000 for the quarter ended March 31, 2008.
Costs and expenses include a decrease in research and development expenses to $2,785,000 for
the quarter ended March 31, 2009 from $4,032,000 for the quarter ended March 31, 2008. This
decrease reflects the changes we implemented in May 2008, when we reprioritized our clinical
development programs to focus primarily on cardiovascular applications. The reprioritization
reduced our overall research and development expenses, including salaries and benefits and other
purchased services. Research and development expenses also included a non-cash charge relating to
share-based compensation expense of $100,000 for the quarter ended March 31, 2009 compared to
$204,000 for the quarter ended March 31, 2008.
Selling, general and administrative expenses decreased for the quarter ended March 31, 2009 to
$1,260,000 from $1,429,000 for the quarter ended March 31, 2008. This decrease is primarily due to
lower salaries and benefits that are the result of the reduction in force that was part of our
reprioritzation of our clinical programs. Selling, general and administrative expenses for the
quarter ended March 31, 2009, included a non-cash charge relating to share-based compensation
expense of $273,000 compared to $324,000 for the quarter ended March 31, 2008.
21
Total costs and expenses decreased to $12,296,000 for the nine months ended March 31, 2009,
compared to $16,599,000 for the nine months ended March 31, 2008.
Research and development expenses decreased for the nine months ended March 31, 2009 to
$8,340,000 from $11,800,000 for the nine months ended March 31, 2008, reflecting the changes we
implemented in May 2008, when we reprioritized our clinical development programs to focus primarily
on cardiovascular applications. The reprioritization reduced our overall research and development
expenses, including salaries and benefits and other purchased services. Research and development
expenses also included a non-cash charge relating to stock-based compensation expense of $435,000
for the nine months ended March 31, 2009 compared to $641,000 for the nine months ended March 31,
2008.
Selling, general and administrative expenses decreased for the nine months ended March 31,
2009 to $3,909,000 from $4,768,000 for the nine months ended March 31, 2008. This decrease is
primarily due to lower salaries and benefits that are the result of the reduction in force that was
part of our reprioritzation of our clinical programs. Selling, general and administrative expenses
for the nine months ended March 31, 2009 included a non-cash charge relating to share-based
compensation expense of $694,000 compared to $994,000 for the nine months ended March 31, 2008.
Interest income was $57,000 and $253,000, respectively, for the quarter and nine months ended
March 31, 2009 compared to $266,000 and $1,017,000, respectively, for the same periods in fiscal
2008. The fluctuations in interest income are due primarily to corresponding changes in the level
of cash, cash equivalents and short-term investments during the periods.
Interest expense was $17,000 and $58,000, respectively, for the quarter and nine months ended
March 31, 2009 compared to $25,000 and $61,000, respectively, for the same periods in fiscal 2008.
Interest expense is related to the secured loan with Key Equipment Finance Inc.
Our net loss was $3,972,000, or $.03 per common share, for the quarter ended March 31, 2009
compared to $5,048,000, or $.04 per common share for the quarter ended March 31, 2008. For the
nine months ended March 31, 2009, our net loss decreased to $11,988,000, or $.09 per common share
compared to a net loss of $15,270,000, or $.12 per common share for the nine months ended March 31,
2008.
Our major ongoing research and development programs are focused on the clinical development of
TRC-based products, utilizing bone marrow-derived adult stem and early progenitor cells, for use in
cardiac and 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. We have discontinued further
patient enrollment into our Phase III ON-CORE (osteonecrosis) bone regeneration trial. We do not
anticipate initiating new clinical bone activity, reactivating the Phase III ON-CORE trial or
initiating formal clinical trials in the neural area without additional financial resources. While
the decision to reprioritize was driven by economic factors, the clinical programs
22
were prioritized
based on anticipated time to market and the perceived relative clinical and market potential.
Compassionate-use clinical activities have been initiated in Europe to evaluate the treatment of
dilated cardiomyopathy using our TRC-based product. All of 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, to improve shelf life, and to
decrease the cost of manufacturing our TRC-based products. Research and development expenses
outside of the TRC-based product development consist primarily of immunotherapy programs,
engineering and cell manufacturing.
The following table summarizes our research and development expenses for the quarter and nine
months ended March 31, 2008 and March 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended March 31, |
|
|
Nine Months Ended March 31, |
|
R&D Project |
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
TRC-based |
|
$ |
3,774,000 |
|
|
$ |
2,785,000 |
|
|
$ |
11,016,000 |
|
|
$ |
8,340,000 |
|
Products |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
258,000 |
|
|
|
|
|
|
|
784,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,032,000 |
|
|
$ |
2,785,000 |
|
|
$ |
11,800,000 |
|
|
$ |
8,340,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, sections under the heading Risk Factors of this report. 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.
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, 2009, have totaled approximately
$212 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.
23
Our combined cash and cash equivalents totaled $19,076,000 at March 31, 2009, a decrease of
$3,386,000 from June 30, 2008. The primary uses of cash, cash equivalents and short-term
investments during the nine months ended March 31, 2009 included $10,586,000 to finance our
operations and working capital requirements, and $34,000 in capital equipment additions. The
primary source of cash, cash equivalents and short-term investments was from equity transactions,
of which net proceeds of $7,343,000 were raised during the nine months ended March 31, 2009,
principally through our agreement with Fusion Capital.
Pursuant to the agreement with Fusion Capital, we had the right over a 25-month period to sell
shares of our common stock to Fusion Capital from time to time in amounts between $60,000 and $2
million, depending on certain conditions as set forth in the agreement, up to an aggregate of $15
million. The number of shares issued to Fusion Capital during each sale was determined based on a
stock price (Purchase Price) that was the lower of the (a) the lowest sale price of common stock
on the purchase date or (b) the arithmetic average of the three (3) lowest closing sale prices of
common stock during the twelve (12) consecutive business days (ten (10) days in certain
circumstances) ending on the business day immediately preceding the purchase date (to be
appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or
other similar
transaction). We controlled the timing and amount of the sales of shares to Fusion
Capital. In accordance with NASDAQ Capital Market rules, Aastrom did not seek shareholder approval
to issue more than 19.99% of its outstanding common stock shares to Fusion Capital.
There were certain events of default which, if such an event were to occur, would have
eliminated the obligation of Fusion Capital to purchase shares from us. Such events included, but
were not limited to, (i) shares of our common stock not being listed on any one of several stock
exchanges outlined in the agreement and (ii) a material adverse change in our business or
operations. In addition, Fusion Capital did not have the obligation to purchase any shares of our
common stock on any business day that the Purchase Price of our common stock is below $0.10. The
common stock purchase agreement could have terminated by us at any time at our discretion without
any cost to us. There were no negative covenants, restrictions on future fundings, penalties or
liquidated damages in the agreement. The proceeds received by us under the common stock purchase
agreement will be used to conduct operations and continue to conduct our clinical development
programs.
In consideration for entering into the agreement, upon execution of the common stock purchase
agreement in October 2008, we issued to Fusion Capital 1,936,317 shares of our common stock as a
commitment fee. Also, we issued to Fusion Capital an additional 1,113,835 shares as a pro rata
commitment fee.
Through March 31, 2009, 21,783,142 shares of the Companys common stock (including 2,887,689
shares related to its commitment fee) were issued to Fusion Capital for net proceeds of $7,335,000.
24
During April 2009, 3,959,674 shares of the Companys common stock (including 162,463 shares
related to its commitment fee) were issued to Fusion Capital for net proceeds of $1,259,000. On
April 29, 2009, the Company issued the final registered shares available under the common stock
purchase agreement with Fusion Capital.
Our monthly cash utilization has averaged approximately $1.2 million for the nine months ended
March 31, 2009. We expect our monthly cash utilization for the remainder of fiscal year 2009 to
average approximately $1.5 million due to increased expenses to conduct our cardiac trial. Our
cash and cash equivalents at April 30, 2009 were $19.5 million.
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 public
or private debt or equity financing transactions, research and development agreements or grants and
distribution and marketing agreements. Successful future operations are subject to several
technical and risk factors,
including our continued ability to obtain future funding, satisfactory product development,
obtaining regulatory approval and market acceptance for our products.
In order to 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 the public or private sale of our equity or debt securities and through
collaborative arrangements. 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.
In addition, we may also pursue strategic transactions or other strategic alternatives in order to
complete our product development programs, complete clinical trials needed to market our products,
and commercialize our products. Several factors will affect our ability to raise additional
funding or enter into strategic transactions or other strategic alternatives, including, 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 Capital 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. See Risk Factors.
25
Management believes, based on its current projections of the Companys cash utilization (which
is expected to approximate between $1.2 - $1.3 million per month) and taking into consideration the
$1.3 million of additional cash raised in April (as described in Note 5), available cash and cash
equivalents on hand as of April 30, 2009 (which equaled approximately $19.5 million) are adequate
to finance the Companys planned operations at least until March 31, 2010. However, we will need
to raise a significant amount of additional funds in order to complete our product development
programs, complete clinical trials needed to market our products, and commercialize these products.
These estimates are based on certain assumptions which could be negatively impacted by the matters
discussed under this heading and under the caption Risk Factors in Item 1a of this report. 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 substantial
additional funds. We will also need significant 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 the public or private sale of our equity or debt securities and
through collaborative arrangements. There can be no assurance that any public or private financing
or such collaborative arrangements, 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.
On March 25, 2009, we received notification from the Listings Qualifications Department of The
NASDAQ Stock Market LLC (NASDAQ) that, given the continued extraordinary market
conditions, NASDAQ had further suspended enforcement of the rules requiring a minimum $1.00
per share closing bid price and a minimum market value of publicly
held shares until July 20,
2009. As a result of NASDAQ further extending the suspension and the balance of 60 days remaining
on our pending compliance period at the time of the initial suspension, we now have until September
18, 2009 to regain compliance with the $1.00 minimum closing bid price rule in order to remain
listed on the NASDAQ Capital Market. We must demonstrate a closing bid price of $1.00 or more for a
minimum of ten consecutive business days to regain compliance. If our common stock is delisted
from the NASDAQ Capital 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.
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 Risk Factors and Notes to Consolidated Financial Statements in our
2008 Annual Report on Form 10-K and Notes to Consolidated Financial Statements and Risk Factors
included herein.
Risk Factors
Our operations and financial results are subject to various risks and uncertainties, including
those described below, that could adversely affect our business, financial condition, results of
operations, cash flows, and trading price of our common stock. The risks and uncertainties
described below are not the only ones we face. There may be additional risks and uncertainties
that are not known to us or that we do not consider to be material at this time. If the events
described in these risks occur, our business, financial condition, and results of operations would
likely suffer.
26
Our past losses and expected future losses cast doubt on our ability to operate profitably.
We were incorporated in 1989 and have experienced substantial operating losses since
inception. As of March 31, 2009, we have incurred a cumulative net loss totaling approximately
$191 million, and we have continued to incur losses since that date. These losses have resulted
principally from costs incurred in the research and development of our cell culture technologies
and our cell manufacturing system, general and administrative expenses, and the prosecution of
patent applications. We expect to continue to incur significant operating losses over the next
several years and at least until, and probably after, product sales increase, primarily owing to
our research and development programs, including preclinical studies and clinical trials, and the
establishment of marketing and distribution capabilities necessary to support commercialization
efforts for our products. We cannot predict with any certainty the amount of future losses. Our
ability to achieve profitability will depend, among other things, on successfully completing the
development of our product candidates, timely initiation and completion of clinical trials,
obtaining regulatory approvals, establishing manufacturing, sales and marketing arrangements with
third parties, maintaining supplies of key manufacturing components, acquisition and development of
complementary activities and raising sufficient cash to fund our operating activities. In
addition, we may not be able to achieve or sustain profitability.
The global economy and capital markets are challenging for the small cap biotech sector. This
situation makes the timing and potential for future equity financings uncertain.
Our stock may be delisted from NASDAQ, which could affect its market price and liquidity.
We are required to meet certain qualitative and financial tests (including a minimum bid price
for our common stock of $1.00 per share) to maintain the listing of our common stock on the NASDAQ
Capital Market. On March 25, 2009, we received notification from the Listings Qualifications
Department of NASDAQ that, given the continued extraordinary market conditions, NASDAQ had further
suspended enforcement of the rules requiring a minimum $1.00 per share closing bid price and a
minimum market value of publicly held shares until July 20, 2009. As a result of NASDAQ further
extending the suspension and the balance of 60 days remaining on our pending compliance period at
the time of the initial suspension, we now have until September 18, 2009 to regain compliance with
the $1.00 minimum closing bid price rule in order to remain listed on the NASDAQ Capital Market.
We can regain compliance with the minimum closing bid price rule if the bid price of our common
stock closes at $1.00 per share or higher for a minimum of ten consecutive business days during the
180-day compliance period, although NASDAQ may, in its discretion, require us to maintain a minimum
closing bid price of at least $1.00 per share for a period
in excess of ten consecutive business days (but generally no more than 20 consecutive business
days) before determining that we have demonstrated the ability to maintain long-term compliance. If
we do not regain compliance during the further extended compliance period, NASDAQ will provide
written notice that our securities will be delisted from the NASDAQ Capital Market. At such time,
we would be able to appeal the delisting determination to a NASDAQ Listing Qualifications Panel.
27
We cannot provide any assurance that our stock price will recover within the permitted grace
period. If our common stock were delisted, it could be more difficult to buy or sell our common
stock and to obtain accurate quotations, and the price of our stock could suffer a material
decline. Delisting may also impair our ability to raise capital.
We may not be able to raise the required capital to conduct our operations and develop and
commercialize our products.
We will require substantial additional capital resources in order to conduct our operations
and develop and commercialize our products and cell manufacturing facilities. In order to grow and
expand our business, to introduce our new product candidates into the marketplace and to acquire or
develop complementary business activities, we will need to raise a significant amount of additional
funds. We will also need significant additional funds or a collaborative partner, or both, to
finance the research and development activities of our cell product candidates for additional
indications. Accordingly, we are continuing to pursue additional sources of financing.
Our future capital requirements will depend upon many factors, including:
|
|
|
continued scientific progress in our research, clinical and development
programs; |
|
|
|
|
costs and timing of conducting clinical trials and seeking regulatory
approvals; |
|
|
|
|
competing technological and market developments; |
|
|
|
|
our ability to establish additional collaborative relationships; |
|
|
|
|
the effect of commercialization activities and facility expansions, if and as
required; and |
|
|
|
|
complementary business acquisition or development opportunities. |
Because of our long-term funding requirements, we intend to try to access the public or
private equity markets if conditions are favorable to complete a financing, even if we do not have
an immediate need for additional capital at that time, or whenever we require additional operating
capital. This additional funding may not be available to us on reasonable terms, or at all. If
adequate funds are not available in the future, we may be required to further delay or terminate
research and development programs, curtail capital expenditures, and reduce business development
and other operating activities.
If we cannot attract and retain key personnel, then our business will suffer.
Our success depends in large part upon our ability to attract and retain highly qualified
scientific and management personnel. We face competition for such personnel from other companies,
research and academic institutions and other entities. Further, in an effort to conserve
financial resources, we have implemented reductions in our work force on three previous occasions.
As a result of these and other factors, we may not be successful in hiring or retaining key
personnel. Our inability to replace any key employee could harm our operations.
28
Failure to obtain and maintain required regulatory approvals would severely limit our ability to
sell our products.
We must obtain the approval of the FDA before commercial sales of our cell product candidates
may commence in the U.S., which we believe will ultimately be the largest market for our products.
We will also be required to obtain additional approvals from various foreign regulatory authorities
to initiate sales activities of cell products in those jurisdictions, including the EU under
regulation of the EMEA. If we cannot demonstrate the safety and efficacy of our cell product
candidates produced in our manufacturing system, we may not be able to obtain required regulatory
approvals. If we cannot demonstrate the safety and efficacy of our product candidates produced in
our manufacturing system, the FDA or other regulatory authorities could delay or withhold
regulatory approval of our product candidates.
Finally, even if we obtain regulatory approval of a product, that approval may be subject to
limitations on the indicated uses for which it may be marketed. Even after granting regulatory
approval, the FDA and regulatory agencies in other countries continue to review and inspect
marketed products, manufacturers and manufacturing facilities, which may create additional
regulatory burdens. Later discovery of previously unknown problems with a product, manufacturer or
facility, may result in restrictions on the product or manufacturer, including a withdrawal of the
product from the market. Further, regulatory agencies may establish additional regulations that
could prevent or delay regulatory approval of our products.
Any changes in the governmental regulatory classifications of our products could prevent, limit or
delay our ability to market or develop our products.
The FDA establishes regulatory requirements based on the classification of a product. Because
our product development programs are designed to satisfy the standards applicable to biological
licensure for our cellular products, any change in the regulatory classification or designation
would affect our ability to obtain FDA approval of our products. Each of these cell products (such
as our TRC-based products) is, under current regulations, regulated as a biologic, which requires a
Biological License Application (BLA).
EU Directives and regulations (laws) have become effective, and have influenced the
requirements for manufacturing cell products and the conduct of clinical trials. Recent changes to
the EU Medicinal Products Prime Directive (including added annexes and new regulations) shifted
patient-derived cells to the medicinal products category which will require Marketing
Authorizations in order to market and sell these products. These new requirements will require
clinical trials with data submission and review by one or more European regulatory bodies. There
is uncertainty about which clinical trial activities and data are required, and because of the
recent nature of these new
directives, laws and regulations, there is no established precedent to fully understand the
requirements for Marketing Authorization.
29
Our inability to complete our product development activities successfully would severely limit our
ability to operate or finance operations.
In order to commercialize our cell product candidates in the U.S. and the EU we must complete
substantial clinical trials, and obtain sufficient safety and efficacy results to support required
registration approval and market acceptance of our cell product candidates. We may not be able to
successfully complete the development of our product candidates, or successfully market our
technologies or product candidates. We, and any of our potential collaborators, may encounter
problems and delays relating to research and development, regulatory approval and intellectual
property rights of our technologies and product candidates. Our research and development programs
may not be successful, and our cell culture technologies and product candidates may not facilitate
the production of cells outside the human body with the expected result. Our technologies and cell
product candidates may not prove to be safe and efficacious in clinical trials, and we may not
obtain the requisite regulatory approvals for our technologies or product candidates and the cells
produced in such products. If any of these events occur, we may not have adequate resources to
continue operations for the period required to resolve the issue delaying commercialization and we
may not be able to raise capital to finance our continued operation during the period required for
resolution of that issue.
We must successfully complete our clinical trials to be able to market certain of our products.
To be able to market therapeutic cell products in the U.S. and across the EU, we must
demonstrate, through extensive preclinical studies and clinical trials, the safety and efficacy of
our processes and product candidates. If our clinical trials are not successful, our products may
not be marketable.
Our ability to complete our clinical trials in a timely manner depends on many factors,
including the rate of patient enrollment. Patient enrollment can vary with the size of the patient
population, the proximity of suitable patients to clinical sites, perceptions of the utility of
cell therapy for the treatment of certain diseases, and the eligibility criteria for the study. We
have experienced delays in patient accrual in our previous and current clinical trials. If we
experience future delays in patient accrual, we could experience increased costs and delays
associated with clinical trials, which would impair our product development programs and our
ability to market our products. Furthermore, the FDA monitors the progress of clinical trials and
it may suspend or terminate clinical trials at any time due to patient safety or other
considerations.
Our research programs are currently directed at improving TRC-based product functionality for
certain clinical indications, improving product shelf life, and decreasing the cost of
manufacturing our TRC-based products. These production process changes may alter the functionality
of our cells and require various additional levels of experimental and clinical testing and
evaluation. Any such testing could lengthen the time before these products would be commercially
available.
Even if successful clinical results are reported for a product from a completed clinical
trial, this does not mean that the results will be sustained over time, or will be sufficient for a
marketable or regulatory approvable product.
30
Failure of third parties to manufacture component parts or provide limited source supplies, or the
imposition of additional regulation, would impair our new product development and our sales
activities.
We rely solely on third parties such as Astro, Ethox, Moll and Lonza to manufacture or supply
certain of our devices/manufacturing equipment, as well as component parts and other materials used
in the cell product manufacturing process. We would not be able to obtain alternate sources of
supply for many of these items on a short-term basis. If any of our key manufacturers or suppliers
fails to perform their respective obligations or if our supply of components or other materials is
limited or interrupted, we would not be able to conduct clinical trials or market our product
candidates on a timely and cost-competitive basis, if at all.
Finally, we may not be able to continue our present arrangements with our suppliers,
supplement existing relationships, establish new relationships or be able to identify and obtain
the ancillary materials that are necessary to develop our product candidates in the future. Our
dependence upon third parties for the supply and manufacture of these items could adversely affect
our ability to develop and deliver commercially feasible products on a timely and competitive
basis.
Manufacturing our cell products in centralized facilities may increase the risk that we will not
have adequate quantities of our cell products for clinical programs.
We rely on third party manufacturers, Fraunhofer Institute for Interfacial Engineering and
Biotechnology in Stuttgart, Germany, the Institute of Laboratory and Transfusion Medicine at the
Heart Center in Bad Oeynhausen, Germany, and the Tissue and Cell Therapy Center at the Blood and
Tissue Bank in Barcelona, Spain, to supply our TRC-based cell products for certain EU clinical
activities. Reliance on third party manufacturers entails risks including regulatory compliance
and quality assurance and the possible breach of the manufacturing agreement by the third party.
We are subject to similar regulatory and compliance risks at our site in Ann Arbor, Michigan. All
sites could be subject to ongoing, periodic, unannounced inspection by regulatory agencies to
ensure strict compliance with GMP regulations and other governmental regulations and corresponding
foreign standards. Our present and future manufacturers might not be able to comply with these
regulatory requirements. We do not have redundant cell manufacturing sites in the U.S. In the
event our cell manufacturing facilities are damaged or destroyed or are subject to regulatory
restrictions, our clinical trial programs and other business prospects would be adversely affected.
Even if we obtain regulatory approvals to sell our products, lack of commercial acceptance could
impair our business.
We will be seeking to obtain regulatory approvals to market our TRC-based cell products for
tissue repair and regeneration treatments. Even if we obtain all required regulatory approvals, we
cannot be certain that our products and processes will be accepted in the marketplace at a level
that would allow us to operate profitably. Our products may be unable to achieve commercial
acceptance for a number of reasons, such as the availability of alternatives that are less
expensive, more effective, or easier to use; the perception of a low cost-benefit ratio for the
product amongst physicians and hospitals; or an inadequate level of product support from ourselves
or a commercial partner. Our technologies or product candidates may not be employed in all
potential applications being investigated, and any reduction in applications would limit the market
acceptance of our technologies and product candidates, and our potential revenues.
31
The market for our products will be heavily dependent on third party reimbursement policies.
Our ability to successfully commercialize our product candidates will depend on the extent to
which government healthcare programs, such as Medicare and Medicaid, as well as private health
insurers, health maintenance organizations and other third party payors will pay for our products
and related treatments. Reimbursement by third party payors depends on a number of factors,
including the payors determination that use of the product is safe and effective, not experimental
or investigational, medically necessary, appropriate for the specific patient and cost-effective.
Reimbursement in the U.S. or foreign countries may not be available or maintained for any of our
product candidates. If we do not obtain approvals for adequate third party reimbursements, we may
not be able to establish or maintain price levels sufficient to realize an appropriate return on
our investment in product development. Any limits on reimbursement from third party payors may
reduce the demand for, or negatively affect the price of, our products. For example, in the past,
published studies suggested that stem cell transplantation for breast cancer, which constituted a
significant portion of the overall stem cell therapy market at the time, may have limited clinical
benefit. The lack of reimbursement for these procedures by insurance payors has negatively
affected the marketability of our products in this indication in the past.
Use of animal-derived materials could harm our product development and commercialization efforts.
Some of the manufacturing materials and/or components we use in, and are critical to,
implementation of our TRC technology involve the use of animal-derived products, including fetal
bovine serum. Suppliers or regulatory changes may limit or restrict the availability of such
materials for clinical and commercial use. We currently purchase all of our fetal bovine sera from
protected herds in Australia and New Zealand. These sources are considered to be the safest and
raise the least amount of concern from the global regulatory agencies. If, for example, the
so-called mad cow disease occurs in New Zealand or in Australia, it may lead to a restricted
supply of the serum currently required for the TRC-based product manufacturing processes. Any
restrictions on these materials would impose a potential competitive disadvantage for our products
or prevent our ability to manufacture TRC-based cell products. Regulatory authorities in the EU
are reviewing the safety issues related to the use of animal-derived materials, which we currently
use in our production process. The FDA has issued draft regulations for controls over bovine
materials. These proposed
regulations do not appear to affect our ability to purchase the manufacturing materials we
currently use. However, the FDA may issue final regulations that could affect our operations. We
do not know what actions, if any, the authorities may take as to animal derived materials specific
to medicinal products distributed in the EU. Our inability to develop or obtain alternative
compounds would harm our product development and commercialization efforts. There are certain
limitations in the supply of certain animal-derived materials, which may lead to delays in our
ability to complete clinical trials or eventually to meet the anticipated market demand for our
cell products.
32
Given our limited internal manufacturing, sales, marketing and distribution capabilities, we need
to develop increased internal capability or collaborative relationships to manufacture, sell,
market and distribute our products.
We have only limited internal manufacturing, sales, marketing and distribution capabilities.
As market needs develop, we intend to establish and operate commercial-scale manufacturing
facilities, which will need to comply with all applicable regulatory requirements. We will also
need to develop new configurations of our cell manufacturing system for these facilities to enable
processes and cost efficiencies associated with large-scale manufacturing. Establishing these
facilities will require significant capital and expertise. We may need to make such expenditures
when there are significant uncertainties as to the market opportunity. Any delay in establishing,
or difficulties in operating, these facilities will limit our ability to meet the anticipated
market demand for our cell products. We intend to get assistance to market some of our future cell
products through collaborative relationships with companies with established sales, marketing and
distribution capabilities. Our inability to develop and maintain those relationships would limit
our ability to market, sell and distribute our products. Our inability to enter into successful,
long-term relationships could require us to develop alternate arrangements at a time when we need
sales, marketing or distribution capabilities to meet existing demand. We may market one or more
of our TRC-based products through our own sales force. Our inability to develop and retain a
qualified sales force could limit our ability to market, sell and distribute our cell products.
The issuance of additional common stock for funding has the potential for substantial dilution.
As noted above, we will need significant additional equity funding, in addition to the
transaction with Fusion Capital, to provide us with the capital to reach our objectives. We may
enter into financing transactions at prices which are at a substantial discount to market. Such an
equity issuance would cause a substantially larger number of shares to be outstanding and would
dilute the ownership interest of existing stockholders.
Our stock price has been volatile and future sales of substantial numbers of our shares could have
an adverse affect on the market price of our shares.
The market price of shares of our common stock has been volatile, ranging in closing price
between $0.16 and $0.73 during the twelve month period ended March 31, 2009. The price of our
common stock may continue to fluctuate in response to a number of events and factors, such as:
|
|
|
clinical trial results |
|
|
|
|
the amount of our cash resources and our ability to obtain additional funding |
|
|
|
|
announcements of research activities, business developments, technological
innovations or new products by us or our competitors |
|
|
|
|
entering into or terminating strategic relationships |
|
|
|
|
changes in government regulation |
|
|
|
|
disputes concerning patents or proprietary rights |
|
|
|
|
changes in our revenues or expense levels |
33
|
|
|
public concern regarding the safety, efficacy or other aspects of the products or
methodologies we are developing |
|
|
|
|
news or reports from other stem cell, cell therapy or regenerative medicine companies |
|
|
|
|
reports by securities analysts |
|
|
|
|
status of the investment markets |
|
|
|
|
concerns related to management transitions |
|
|
|
|
delisting from the NASDAQ Capital Market |
Any of these events may cause the price of our shares to fall, which may adversely affect our
business and financing opportunities. In addition, the stock market in general and the market
prices for biotechnology companies in particular have experienced significant volatility recently
that often has been unrelated to the operating performance or financial conditions of such
companies. These broad market and industry fluctuations may adversely affect the trading price of
our stock, regardless of our operating performance or prospects.
If we do not keep pace with our competitors and with technological and market changes, our products
will become obsolete and our business may suffer.
The markets for our products are very competitive, subject to rapid technological changes, and
vary for different candidates and processes that directly compete with our products. Our
competitors may have developed, or could in the future develop, new technologies that compete with
our products or even render our products obsolete. As an example, in the past, published studies
have suggested that hematopoietic stem cell therapy use for bone marrow transplantation, following
marrow ablation due to chemotherapy, may have limited clinical benefit in the treatment of breast
cancer, which was a significant portion of the overall hematopoietic stem cell transplant market.
This resulted in the practical elimination of this market for our cell-based product for this
application.
Our cell manufacturing system is designed to improve and automate the processes for producing
cells used in therapeutic procedures. Even if we are able to demonstrate improved or equivalent
results, the cost or process of treatment and other factors may cause researchers and practitioners
to not use our products and we could suffer a competitive disadvantage. Finally, to the extent
that others develop new technologies that address the targeted application for our products, our
business will suffer.
If our patents and proprietary rights do not provide substantial protection, then our business and
competitive position will suffer.
Our success depends in large part on our ability to develop or license and protect proprietary
products and technologies. However, patents may not be granted on any of our pending or future
patent applications. Also, the scope of any of our issued patents may not be sufficiently broad to
offer meaningful protection. In addition, our issued patents or patents licensed to us could be
successfully challenged, invalidated or circumvented so that our patent rights would not create an
effective competitive barrier. Certain patent equivalents to the U.S. patents have also been
issued in other jurisdictions including Australia, Japan, the Republic of Korea, Canada and under
the
34
European Convention. Furthermore, we rely on exclusive, world-wide licenses relating to the
production of human cells granted to us by the University of Michigan for certain of our patent
rights. If we materially breach such agreements or otherwise fail to materially comply with such
agreements, or if such agreements expire or are otherwise terminated by us, we may lose our rights
under the patents held by the University of Michigan. At the latest, each of these licenses will
terminate when the patent underlying the license expires. The first of these underlying patents
will expire on March 21, 2012. We also rely on trade secrets and unpatentable know-how that we
seek to protect, in part, by confidentiality agreements with our employees, consultants, suppliers
and licensees. These agreements may be breached, and we might not have adequate remedies for any
breach. If this were to occur, our business and competitive position would suffer.
Intellectual property litigation could harm our business.
Our success will also depend in part on our ability to develop commercially viable products
without infringing the proprietary rights of others. Although we have not been subject to any
filed infringement claims, other patents could exist or could be filed which would prohibit or
limit our ability to market our products or maintain our competitive position. In the event of an
intellectual property dispute, we may be forced to litigate. Intellectual property litigation
would divert managements attention from developing our products and would force us to incur
substantial costs regardless of whether we are successful. An adverse outcome could subject us to
significant liabilities to third parties, and force us to curtail or cease the development and sale
of our products and processes.
The government maintains certain rights in technology that we develop using government grant money
and we may lose the revenues from such technology if we do not commercialize and utilize the
technology pursuant to established government guidelines.
Certain of our and our licensors research have been or are being funded in part by government
grants. As a result of such funding, the U.S. Government has established guidelines and have
certain rights in the technology developed with the grant. If we fail to meet these guidelines, we
would lose our exclusive rights to these products, and we would lose potential revenue derived from
the sale of these products.
Potential product liability claims could affect our earnings and financial condition.
We face an inherent business risk of exposure to product liability claims in the event that
the manufacture and/or use of TRC-based products during clinical trials, or after
commercialization, results in adverse events. As a result, we may incur significant product
liability exposure, which could exceed existing insurance coverage. We may not be able to maintain
adequate levels of insurance at reasonable cost and/or reasonable terms. Excessive insurance costs
or uninsured claims would increase our operating loss and affect our financial condition.
35
Our corporate documents and Michigan law contain provisions that may make it more difficult for us
to be acquired.
Our Board of Directors has the authority, without shareholder approval, to issue additional
shares of preferred stock and to fix the rights, preferences, privileges and restrictions of these
shares without any further vote or action by our shareholders. This authority, together with
certain provisions of our charter documents, may have the effect of making it more difficult for a
third party to acquire, or of discouraging a third party from attempting to acquire control of our
Company. This effect could occur even if our shareholders consider the change in control to be in
their best interest.
We are required to evaluate our internal control over financial reporting under Section 404 of the
Sarbanes-Oxley Act of 2002 and any adverse results from such evaluation could have a negative
market reaction.
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 (Section 404), we are required to
furnish a report by our management on our internal control over financial reporting. That report
must contain, among other matters, an assessment of the design and operating effectiveness of our
internal controls over financial reporting as of the end of the fiscal year. This assessment must
include disclosure of any material weaknesses in our internal control over financial reporting
identified by management. That report must also contain a statement that our independent
registered public accounting firm has issued an attestation report on the design and operating
effectiveness of our system of internal accounting controls over financial reporting. If in the
future we are unable to assert that our internal control over financial reporting is effective as
of the end of the then current fiscal year (or, if our independent registered public accounting
firm is unable to express an unqualified opinion on the design and operating effectiveness of our
internal controls), we could lose investor confidence in the accuracy and completeness of our
financial reports, which would have a negative effect on our stock price and our ability to raise
capital.
Forward-looking statements
This report, including the documents that we incorporate by reference, contains
forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E
of the Securities Exchange Act. Any statements about our expectations, beliefs, plans, objectives,
assumptions or future events or performance are not historical facts and may be forward-looking.
These statements are often, but are not always, made through the use of words or phrases such as
anticipates, estimates, plans, projects, trends, opportunity, comfortable, current,
intention, position, assume, potential, outlook, remain, continue, maintain,
sustain, seek, achieve, continuing, ongoing, expects, management believes, we
believe, we intend and similar words or phrases, or future or conditional verbs such as will,
would, should, could, may, or similar expressions. Accordingly, these statements involve
estimates, assumptions and uncertainties which could cause actual results to differ materially from
those expressed in them. Any forward-looking statements are qualified in their entirety by
reference to the factors discussed throughout this report, and in particular those factors listed
under the section Risk Factors.
36
Because the factors referred to in the preceding paragraph could cause actual results or
outcomes to differ materially from those expressed in any forward-looking statements we make, you
should not place undue reliance on any such forward-looking statements. Further, any
forward-looking statement speaks only as of the date on which it is made, and we undertake no
obligation to update any forward-looking statement or statements to reflect events or circumstances
after the date on which such statement is made or to reflect the occurrence of unanticipated
events. New factors emerge from time to time, and it is not possible for us to predict which
factors will arise. In addition, we cannot assess the impact of each factor on our business or the
extent to which any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements. These forward-looking
statements include statements regarding:
|
|
|
potential strategic collaborations with others |
|
|
|
|
future capital needs |
|
|
|
|
adequacy of existing capital to support operations for a specified time |
|
|
|
|
product development and marketing plan |
|
|
|
|
clinical trial plans and anticipated results |
|
|
|
|
anticipation of future losses |
|
|
|
|
replacement of manufacturing sources |
|
|
|
|
commercialization plans |
|
|
|
|
revenue expectations and operating results |
37
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As of March 31, 2009, our cash and cash equivalents included money market securities,
therefore, we would not expect our operating results or cash flows to be affected to any
significant degree by the effect of a sudden change in market interest rates or credit conditions
on our securities portfolio.
Our sales to customers in foreign countries are denominated in U.S. dollars or Euros. Our
vendors, employees and clinical sites in countries outside the U.S. are typically paid in Euros.
However, such expenditures have not been significant to date. Accordingly, we are not directly
exposed to significant market risks from currency exchange rate fluctuations. We believe that the
interest rate risk related to our accounts receivable is not significant. We manage the risk
associated with these accounts through periodic reviews of the carrying value for
non-collectibility and establishment of appropriate allowances. We do not enter into hedging
transactions and do not purchase derivative instruments.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
The Company conducted an evaluation, under the supervision and with the participation of
management, including the Chief Executive Officer (CEO)/Chief Financial Officer (CFO), who
currently is the same individual, of the effectiveness of the design and operation of the Companys
disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities
and Exchange Act of 1934, as amended (the Exchange Act). Based on that evaluation, the CEO/CFO
has concluded that the Companys disclosure controls and procedures were effective as of March 31,
2009 to ensure that information related to the Company required to be disclosed in reports the
Company files or submits under the Exchange Act is (i) recorded, processed, summarized and reported
within the time periods specified in the SECs rules and forms, and (ii) accumulated and
communicated to the Companys management, including the CEO/CFO, to allow timely decisions
regarding required disclosure. Because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that the Companys disclosure controls and
procedures will detect or uncover every situation involving the failure of persons within the
Company to disclose material information otherwise required to be set forth in the Companys
periodic reports; however, the Companys disclosure controls are designed to provide reasonable
assurance that they will achieve their objective of timely alerting the CEO/CFO to the information
relating to the Company required to be disclosed in the Companys periodic reports required to be
filed with the SEC.
38
Changes in Internal Control over Financial Reporting
During our third quarter of fiscal 2009, there were no changes made in our internal control
over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange
Act) occurred that have materially affected, or are reasonably likely to materially affect, the
Companys internal control over financial reporting.
39
PART
II - OTHER INFORMATION
Item 1. Legal Proceedings
From time to time we receive threats or may be subject to litigation matters incidental to our
business. However, we are not currently a party to any material pending legal proceedings.
Item 1A. Risk Factors
We have provided updated risk factors in the section labeled Risk Factors in Part I, Item 2
to allow readers to understand the material risks and uncertainties affecting our businesses and to
qualify forward-looking statements we make.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits
See Exhibit Index.
40
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.
|
|
|
|
|
|
AASTROM BIOSCIENCES, INC.
|
|
Date: May 8, 2009 |
/s/ George W. Dunbar, Jr.
|
|
|
George W. Dunbar, Jr. |
|
|
President and Chief Executive Officer
(Principal Executive Officer)
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
41
EXHIBIT INDEX
|
|
|
Exhibit Number |
|
Description |
|
|
|
31.1
|
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.1
|
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 |
42
GLOSSARY
|
|
|
TERM |
|
DEFINITION |
Adult Stem Cell
|
|
A cell present in adults that
can generate a limited range
of cell types as well as renew
itself. |
|
|
|
Adverse Event
|
|
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. |
|
|
|
AEMPS Agencia Española de Medicamentos
y Productos Sanitarios
|
|
Spanish Regulatory Agency |
|
|
|
Allogeneic
|
|
Originating from someone other
than the patient receiving
treatment. (Aastrom does NOT
use allogeneic cells) |
|
|
|
ATMP Advanced Therapy Medicinal Product
|
|
New medical products in the
European Union based on genes
(gene therapy), cells (cell
therapy) and tissues (tissue
engineering). |
|
|
|
Autologous
|
|
Originating from the patient
receiving treatment. (Aastrom
uses only autologous cells) |
|
|
|
BLA Biologics License Application
|
|
An application containing
product safety, efficacy and
manufacturing information
required by the FDA to market
biologics products in the U.S
(equivalent to NDA) |
|
|
|
BRC Bone Repair Cell
|
|
Aastroms proprietary Tissue
Repair Cells for bone
indications. (Also see TRC
Tissue Repair Cell) |
|
|
|
CBER Center for Biologics Evaluation
and Research
|
|
Branch of the FDA that
regulates biological products
for disease prevention and
treatment that are inherently
more complex than chemically
synthesized pharmaceuticals. |
|
|
|
CLI Critical Limb Ischemia
|
|
A vascular disease
characterized by insufficient
blood flow in the lower
extremities that causes severe
pain, tissue loss or both. |
43
|
|
|
TERM |
|
DEFINITION |
Controlled Clinical Trial
|
|
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. |
|
|
|
CRC Cardiac Repair Cell
|
|
Aastroms proprietary Tissue
Repair Cells for cardiac
indications. (Also see TRC
Tissue Repair Cell) |
|
|
|
DCM Dilated Cardiomyopathy
|
|
A chronic cardiac disease where
expansion of the patients heart
reduces the pumping function to a
point that the normal circulation
of blood cannot be maintained. |
|
|
|
Double-Blind Clinical Trial
|
|
Clinical trials in which neither
the patient nor the physician
know if the patient received the
experimental treatment or a
control/placebo. |
|
|
|
LVEF Left Ventricle Ejection Fraction
|
|
The fraction of blood pumped out
of the left ventricle with each
heart beat. |
|
|
|
EMEA European Medicines Agency
|
|
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 EU the best-possible 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 EU
legislation relating to medicinal
products. EMEA is similar in function to
the US FDA (see FDA below). |
|
|
|
EU European Union
|
|
The economic and political union of 27
member states, located primarily in
Europe, for which the EMEA holds the
medical regulatory power. |
|
|
|
Ex vivo
|
|
Outside the body |
44
|
|
|
TERM |
|
DEFINITION |
FDA Food & Drug Administration
|
|
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. |
|
|
|
GMP Good Manufacturing Practice
|
|
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. |
|
|
|
GTP Good Tissue Practice
|
|
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. |
45
|
|
|
TERM |
|
DEFINITION |
Hematopoietic Stem Cells
|
|
Stem cells that give rise to all the 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). |
|
|
|
IMPACT-DCM
|
|
Aastroms U.S. Phase II dilated cardiomyopathy
clinical trial. |
|
|
|
IMPD Investigational Medicinal Product
Dossier
|
|
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. |
|
|
|
In vitro
|
|
In a laboratory dish or test
tube; in an artificial
environment |
|
|
|
IND Investigational New Drug
|
|
An application submitted to
the FDA for a new drug or
biological drug that, if
approved, will be used in a
clinical trial. |
|
|
|
IRB Institutional Review Board
|
|
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. |
|
|
|
Non-union Fractures
|
|
Broken bones that have failed
to unite and heal |
|
|
|
NRC Neural Repair Cell
|
|
Aastroms proprietary Tissue
Repair Cells for Neural
indications (Also see TRC
Tissue Repair Cell) |
|
|
|
ON Osteonecrosis
|
|
A progressive bone disease
characterized by death of
bony tissue due to
insufficient blood flow
within the bone. |
46
|
|
|
TERM |
|
DEFINITION |
ON-CORE
|
|
Aastroms U.S. Phase III
osteonecrosis of the femoral
head clinical trial |
|
|
|
Open-label Clinical Trial
|
|
A trial in which both the
treating physician and the
patient know whether they are
receiving the experimental
treatment or control/placebo
treatment. |
|
|
|
Orphan Drug Designation
|
|
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. |
|
|
|
Osteoblast
|
|
A bone forming cell |
|
|
|
Phase I Clinical Trial
|
|
A Phase I trial represents an initial study in a
small group of patients to test for safety and
other relevant factors |
|
|
|
Phase II Clinical Trial
|
|
A Phase II trial represents a study in a moderate
number of patients to assess the safety and
efficacy of a product |
|
|
|
Phase IIb Clinical Trial
|
|
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 |
|
|
|
Phase III Clinical Trial
|
|
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. |
|
|
|
Progenitor Cells
|
|
A parent cell that gives rise to a distinct
cell lineage by a series of cell divisions. |
|
|
|
Prospective Clinical Trial
|
|
A clinical trial in which participants are
identified and then followed for a period of
time during and after the conclusion of a
clinical trial. |
47
|
|
|
TERM |
|
DEFINITION |
Randomized Clinical Trial
|
|
A clinical trial in which the participants are
assigned randomly to different treatment
groups. |
|
|
|
Somatic Cell
|
|
Any of the cells that are responsible for
forming the body of an organism such as
internal organs, bones, skin, connective
tissues and blood. |
|
|
|
SPP Single-Pass Perfusion
|
|
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. |
|
|
|
Standard of care treatment
|
|
The treatment normally prescribed in medical
practice for a particular illness, injury or
procedure. |
|
|
|
Stem Cell
|
|
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
possesse the ability to divide for indefinite
periods in culture and may give rise to
highly specialized cells. |
|
|
|
TRC Tissue Repair Cell
|
|
Aastroms cell manufacturing process begins
with the collection of a small aspirate 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. |
|
VRC Vascular Repair Cell
|
|
Aastroms proprietary Tissue Repair Cells for
Vascular indications. (Also see TRC Tissue
Repair Cell) |
48
exv31w1
Exhibit 31.1
CERTIFICATION
I, George W. Dunbar, Jr., certify that:
|
1. |
|
I have reviewed this Quarterly Report on Form 10-Q of Aastrom Biosciences, Inc.; |
|
|
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. |
|
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.
Date: May 8, 2009
|
|
|
/s/ George W. Dunbar, Jr.
George W. Dunbar, Jr.
|
|
|
President and Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
|
Chief Financial Officer |
|
|
(Principal Financial and Accounting Officer) |
|
|
exv32w1
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Aastrom Biosciences, Inc. (the Company) on Form
10-Q for the quarter ended March 31, 2009, as filed with the Securities and Exchange Commission on
the date hereof (the Report), I, George W. Dunbar, Jr., President and Chief Executive Officer and
Chief Financial Officer 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), that to my knowledge:
(1) The Report fully complies with the requirements of section 13(a) or 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.
May 8, 2009
|
|
|
/s/ George W. Dunbar, Jr.
George W. Dunbar, Jr.
|
|
|
President and Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
|
Chief Financial Officer |
|
|
(Principal Financial and Accounting Officer) |
|
|
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.