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As filed with the Securities and Exchange Commission on November 10, 2008.
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
AASTROM BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Michigan
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94-3096597 |
(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer Identification
Number) |
24 Frank Lloyd Wright Drive
P.O. Box 376
Ann Arbor, Michigan 48106
(734) 930-5555
(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)
George W. Dunbar, Jr.
President and Chief Executive Officer
Aastrom Biosciences, Inc.
P.O. Box 376
Ann Arbor, Michigan 48106
(734) 930-5555
(Name, address, including zip code, and telephone number, including area code, of agent for service)
With a copy to:
Allan J. Reich
Seyfarth Shaw
131 South Dearborn Street
Suite 2400
Chicago, Illinois 60603
Telephone: (312) 460-5650
Facsimile: (312) 460-7650
Approximate date of commencement of proposed sale to the public: From time to time after this
Registration Statement becomes effective.
If the only securities being registered on this form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
If any of the securities being registered on this Form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the following box: þ
If this form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act, please check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act,
check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. o
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective
amendment thereto that shall become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a registration statement filed pursuant to General
Instruction I.D. filed to register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check the following box. 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):
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer o
(Do not check if a smaller reporting company) |
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Smaller reporting company
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CALCULATION OF REGISTRATION FEE
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Proposed |
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Amount to |
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Proposed Maximum |
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Maximum |
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Title of Each Class of |
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be |
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Offering Price Per |
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Aggregate |
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Amount of |
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Securities To be Registered |
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Registered |
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Share(1) |
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Offering Price(1) |
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Registration Fee |
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Common Stock, no par value |
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26,565,299 |
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$0.495 |
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13,149,823 |
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$517 |
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(1) |
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Estimated pursuant to Rule 457(c), solely for the purpose of calculating the registration fee
based on the average of the high and low prices for the common stock, as reported on the Nasdaq
Stock Market on November 6, 2008. Under the common stock purchase agreement, Fusion Capital has
agreed to purchase up to $15.0 million of newly issued shares of the Companys common stock.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY
TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT HAS FILED A FURTHER AMENDMENT THAT SPECIFICALLY
STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH
SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION ACTING PURSUANT TO SAID SECTION 8(A), MAY DETERMINE. |
The information in this prospectus is not complete and may be changed. We may not sell these
securities until the registration statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities and we are not soliciting
offers to buy these securities in any state where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED NOVEMBER 10, 2008.
PROSPECTUS
AASTROM BIOSCIENCES, INC.
26,565,299 Shares of Common Stock
This prospectus relates to the sale of up to 26,565,299 shares of our common stock by Fusion
Capital Fund II, LLC. Fusion Capital is sometimes referred to in this prospectus as the selling
shareholder. The prices at which Fusion Capital may sell the shares will be determined by the
prevailing market price for the shares or in negotiated transactions. We will not receive proceeds
from the sale of our shares by Fusion Capital.
Our common stock is registered under Section 12(b) of the Securities Exchange Act of 1934 and
quoted on the Nasdaq Capital Market under the symbol ASTM. On November 3, the last reported sale
price for our common stock as reported on the Nasdaq Capital Market was $0.63 per share. We have
applied to have the shares of common stock offered pursuant to this prospectus approved for listing
on the Nasdaq Capital Market.
Investing in the common stock involves certain risks. See Risk Factors beginning on page 5
for a discussion of these risks.
The selling shareholder is an underwriter within the meaning of the Securities Act of 1933,
as amended.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The date of this Prospectus is November 10, 2008.
TABLE OF CONTENTS
You may rely only on the information provided or incorporated by reference in this Prospectus.
Neither we nor the selling stockholder have authorized anyone to provide information different
from that contained in this Prospectus. Neither the delivery of this Prospectus nor the sale of
the securities means that the information contained in this Prospectus is correct after the date of
this Prospectus. This Prospectus is not an offer to sell or solicitation to buy the securities in
any circumstances under which the offer or solicitation is unlawful.
PROSPECTUS SUMMARY
The following summary highlights information contained elsewhere in this Prospectus. It may
not contain all of the information that is important to you. You should read the entire Prospectus
carefully, especially the discussion regarding the risks of investing in our common stock under the
heading Risk Factors, before investing in our common stock. In this Prospectus, Aastrom, we,
us, and our refer to Aastrom Biosciences, Inc.
Business
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 290 patients, and are
currently in the following stages of development:
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Cardiac regeneration Cardiac Repair Cells (CRCs): |
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Dilated cardiomyopathy (DCM) (severe chronic disease of the heart): |
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U.S.: IMPACT-DCM Phase II clinical trial open for patient enrollment at one
clinical site (The Methodist Hospital, Houston, TX); initiating four other clinical
sites; patient treatments expected during the 4th quarter of calendar year
2008; Orphan Drug Designation from the FDA for use in treatment of DCM |
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Germany: Encouraging data reported April 2008 from compassionate use treatment in
patients |
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Vascular regeneration Vascular Repair Cells (VRCs): |
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Critical limb ischemia (CLI): |
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U.S.: RESTORE-CLI Phase IIb clinical trial treated first 30 patients; 12-month
interim data analyzed after the 30th patient followed for 12 months
(expected to occur during the 4th quarter of calendar year 2009); patient enrollment
continues |
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Germany: Phase I/II investigator-sponsored clinical trial completed enrollment and
patient follow-up ongoing; positive interim data reported October 2007 |
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Bone regeneration Bone Repair Cells (BRCs): |
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Osteonecrosis of the femoral head: |
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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 |
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Spain: Clinical trial enrolling patients |
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Germany: Positive data reported October 2007 from compassionate use treatment
cases |
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U.S.: Positive 12-month results from Phase I/II clinical trial reported by
investigator October 2007 |
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Spain: 24-month follow-up continuing on fully-enrolled 10-patient
investigator-sponsored Phase II clinical trial |
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Neural regeneration Neural Repair Cells (NRCs): |
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Plans for clinical program on hold |
1
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 cell component 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.
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In May 2008, we reprioritized our clinical development programs to primarily focus 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 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 the 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 September 30, 2008, we have accumulated a net loss of approximately $183
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.
Corporate Information
Aastrom is incorporated under the laws of the State of Michigan. Our principal executive
offices are located at 24 Frank Lloyd Wright Drive, P.O. Box 376, Ann Arbor, Michigan 48106. Our
telephone number is (734) 930-5555. The address of our website is www.aastrom.com. Information on
our website is not part of this Prospectus.
Our Common Stock
Our common stock trades on the Nasdaq Capital Market under the symbol ASTM.
The Offering
On October 27, 2008, we entered into a Common Stock Purchase Agreement with Fusion Capital
Fund II, LLC, an Illinois limited liability company. Under the Purchase Agreement, Fusion Capital
is obligated, under certain conditions, to purchase shares from us in an aggregate amount of $15.0
million from time to time over a 25-month period. Under the terms of the Purchase Agreement,
Fusion Capital has received a commitment fee consisting of 1,936,317 shares of our common stock.
Also, we will issue to Fusion Capital an additional 1,936,317 shares as a commitment fee pro rata
as we receive the $15.0 million of future funding. As of October 27, 2008, there were 132,826,495
shares outstanding (132,668,795 shares held by non-
affiliates) excluding the 22,692,665 shares that Fusion Capital has not yet purchased and the
1,936,317 shares of additional commitment shares that Fusion Capital has not yet received from us.
If all of such 24,628,982 shares offered hereby were issued and outstanding as of the date hereof,
the 24,628,982 shares would represent 18.5% of the total common stock outstanding or 19% of the
non-affiliates shares outstanding as of the date hereof.
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Under the Purchase Agreement and the Registration Rights Agreement we are required to register
and have included in the offering pursuant to this Prospectus (1) 1,936,317 shares which have
already been issued, (2) an additional 1,936,317 shares which we may issue in the future as a
commitment fee pro rata as we receive the $15.0 million of future funding and (3) at least
22,692,665 shares which we may sell to Fusion Capital after this registration statement is declared
effective. All 26,565,299 shares, 20.0% of our outstanding on October 27, 2008, the date of the
Purchase Agreement, are being offered pursuant to this Prospectus. Under the Purchase Agreement,
we have the right but not the obligation to sell more than the 22,692,665 shares to Fusion Capital.
As of the date hereof, we do not currently have any plans or intent to sell to Fusion Capital any
shares beyond the 22,692,665 shares offered hereby. However, if we elect to sell more than the
22,692,665 shares (which we have the right but not the obligation to do), we must first register
under the Securities Act any additional shares we may elect to sell to Fusion Capital before we can
sell such additional shares, which could cause substantial dilution to our shareholders. In
addition, in the event that we decide to issue more than 26,565,299, i.e. greater than 19.99% of
our outstanding shares of common stock as of the date of the Purchase Agreement, we would first be
required to seek shareholder approval in order to be in compliance with the Nasdaq Capital Market
rules. The number of shares ultimately offered for sale by Fusion Capital is dependent upon the
number of shares purchased by Fusion Capital under the Purchase Agreement.
We do not have the right to commence any sales of our shares to Fusion Capital until the SEC
has declared effective the registration statement of which this Prospectus is a part. After the
SEC has declared effective such registration statement, generally we have the right but not the
obligation from time to time to sell our shares to Fusion Capital in amounts between $60,000 and
$2.0 million depending on certain conditions. We have the right to control the timing and amount
of any sales of our shares to Fusion Capital. The purchase price of the shares will be determined
based upon the market price of our shares without any fixed discount at the time of each sale.
Fusion Capital shall not have the right nor the obligation to purchase any shares of our common
stock on any business day that the price of our common stock is below $0.10. There are no negative
covenants, restrictions on future fundings, penalties or liquidated damages in the Purchase
Agreement or the Registration Rights Agreement. The Purchase Agreement may be terminated by us at
any time at our discretion without any cost to us. The Purchase Agreement provides that neither
party has the ability to amend the Purchase Agreement and the obligations of both parties are
non-transferable.
4
RISK FACTORS
You should carefully consider the risks described below before purchasing our common stock.
Our most significant risks and uncertainties are described below; however, they are not the only
risks we face. If any of the following risks actually occur, our business, financial condition, or
results or operations could be materially adversely affected, the business of our common stock
could decline, and you may lose all or part of your investment therein. You should acquire shares
of our common stock only if you can afford to lose your entire investment.
The risk factors described below are not all inclusive. All risk factors should be considered
carefully when evaluating our business, results of operations, and financial position. We
undertake no obligation to update forward-looking statements or risk factors. There may be other
risks and uncertainties not highlighted herein that may become material factors affecting our
financial condition and business operations.
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 September 30, 2008, we have incurred a cumulative net loss totaling approximately
$183 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 current global economy and capital markets have been challenging for any issuer to raise
capital through public offerings or private placements of its securities, and especially so with
respect to the small cap biotech sector. This situation makes the timing and potential for future
equity financings uncertain. As a result, we have taken actions intended to reduce our estimated
average cash utilization to approximately $1.2 million per month for fiscal year ending June 30,
2009, through a combination of development and clinical program reprioritizations and adjustments
focusing on our cardiac regeneration program, along with reductions in overhead and staff which
occurred in May 2008.
5
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 December 20, 2007, we received a deficiency letter from the Nasdaq Stock Market
indicating that for 30 consecutive trading days our common stock had a closing bid price below the
$1.00 per share minimum closing bid as required for continued listing set forth in Nasdaq
Marketplace Rule 4310(c)(4). In accordance with Nasdaq Marketplace Rule 4310(c)(8)(D), we were
provided a compliance period of 180 calendar days, or until June 17, 2008, to regain compliance
with this requirement. On June 17, 2008, we had not yet regained compliance with the requirement
and were granted an additional 180-day compliance period, or until December 15, 2008 to regain
compliance. On October 22, 2008, we received notice from Nasdaq that the period during which we
were granted to gain compliance with the bid price requirement had been suspended and that, upon
completion of the suspension period, we would have until March 20, 2009 to regain compliance with
the requirement. 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 additional 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.
We cannot provide any assurance that our stock price will again 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.
In addition to our financing with Fusion, 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.
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Our future capital requirements will depend upon many factors, including:
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continued scientific progress in our research, clinical and development
programs; |
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costs and timing of conducting clinical trials and seeking regulatory approvals; |
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competing technological and market developments; |
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our ability to establish additional collaborative relationships; |
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the effect of commercialization activities and facility expansions, if and as
required; and |
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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.
The transaction with Fusion may provide us with some of the required capital to conduct our
operations; however, we expect that we will need additional capital. In addition, under certain
conditions, Fusion will not be required to purchase our shares, including if the market price of
our common stock is less than $0.10, if we are not listed on a national exchange or the OTC
Bulletin Board or if there is a material adverse change to our business, properties, operations,
financial condition or results of operations. In addition, our ability to raise the entire $15
million will be dependent on the stock price of our common stock as we will not be able to sell
greater than 19.99% of our outstanding shares of common stock as of the date of the Purchase
Agreement without obtaining shareholder approval.
We only have the right to receive $60,000 every two business days under the Purchase Agreement
unless our stock price equals or exceeds $0.25, in which case we can sell greater amounts to Fusion
Capital as the price of our common stock increases. Since we will be limited to 22,692,665 shares
sold to Fusion Capital, the selling price of our common stock to Fusion Capital will have to
average at least $0.66 per share for us to receive the maximum proceeds of $15.0 million. Assuming
a purchase price of $0.63 per share (the closing sale price of the common stock on November 3,
2008) and the purchase by Fusion Capital of the full 22,692,665 shares under the Purchase
Agreement, proceeds to us would only be $9,077,066 unless we choose to register more than
22,692,665 shares, which we have the right, but not the obligation, to do. Subject to approval by
our board of directors, we have the right but not the obligation to sell more than 22,692,665
shares to Fusion Capital. In the event we elect to sell more than 22,692,665 shares offered
hereby, we will be required to file a new registration statement and have it declared effective by
the U.S. Securities & Exchange Commission. In addition, in the event that we decide to issue more
than 26,565,299, i.e. greater than 19.99% of our outstanding shares of common stock as of the date
of the Purchase Agreement, we would first be required to seek shareholder approval in order to be
in compliance with the Nasdaq Capital Market rules.
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The extent we rely on Fusion Capital as a source of funding will depend on a number of factors
including, the prevailing market price of our common stock and the extent to which we
are able to secure working capital from other sources. Specifically, Fusion Capital shall not
have the right nor the obligation to purchase any shares of our common stock on any business days
that the market price of our common stock is less than $0.10. Even if we are able to access the
full $15.0 million under the Purchase Agreement with Fusion Capital, we will need additional
capital to fully implement our business, operating and development plans. Should the financing we
require to sustain our working capital needs be unavailable or prohibitively expensive when we
require it, the consequences could be a material adverse effect on our business, operating results,
financial condition and prospects.
The sale of our common stock to Fusion Capital may cause dilution and the sale of the shares of
common stock acquired by Fusion Capital could cause the price of our common stock to decline
In connection with entering into the Purchase Agreement, we authorized the sale to Fusion
Capital of up to 22,692,665 shares of our common stock. The number of shares ultimately offered
for sale by Fusion Capital under this prospectus is dependent upon the number of shares purchased
by Fusion Capital under the Purchase Agreement. The purchase price for the common stock to be sold
to Fusion Capital pursuant to the Purchase Agreement will fluctuate based on the price of our
common stock. All 26,595,299 shares registered in this offering are expected to be freely
tradable. It is anticipated that shares registered in this offering will be sold over a period of
up to 25 months from the date of this prospectus. Depending upon market liquidity at the time, a
sale of shares under this offering at any given time could cause the trading price of our common
stock to decline. Fusion Capital may ultimately purchase all, some or none of the 22,692,665
shares of common stock not yet issued but registered in this offering. After it has acquired such
shares, it may sell all, some or none of such shares. Therefore, sales to Fusion Capital by us
under the Purchase Agreement may result in substantial dilution to the interests of other holders
of our common stock. The sale of a substantial number of shares of our common stock under this
offering, or anticipation of such sales, could make it more difficult for us to sell equity or
equity-related securities in the future at a time and at a price that we might otherwise wish to
effect sales. However, we have the right to control the timing and amount of any sales of our
shares to Fusion Capital and the Purchase Agreement may be terminated by us at any time at our
discretion without any cost to us.
We have experienced significant management turnover, and 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.
8
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
regulations of the EMEA. If we cannot demonstrate the safety and efficacy of our cell product
candidates, or of the cells 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, 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 mixtures (such
as our TRC-based products) is, under current regulations, regulated as a biologic product, 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
understand the timeline or other requirements for Marketing Authorization.
9
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.
10
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.
11
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.
12
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, 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 $1.04 during the twelve month period ended October 31, 2008. The price of our
common stock may continue to fluctuate in response to a number of events and factors, such as:
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clinical trial results; |
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the amount of our cash resources and our ability to obtain additional funding; |
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announcements of research activities, business developments, technological
innovations or new products by us or our competitors; |
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entering into or terminating strategic relationships; |
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changes in government regulation; |
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disputes concerning patents or proprietary rights; |
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changes in our revenues or expense levels; |
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public concern regarding the safety, efficacy or other aspects of the products
or methodologies we are developing; |
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news or reports from other stem cell, cell therapy or regenerative medicine
companies; |
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reports by securities analysts; |
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status of the investment markets; |
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concerns related to management transitions; and |
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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.
14
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 European Convention. Certain of these foreign patents are due expire
beginning in 2008. 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.
15
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 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. In addition, we are subject to
certain anti-takeover provisions of Michigan law that could delay or make more difficult a merger
or tender offer involving our company.
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.
16
INCORPORATION BY REFERENCE
This prospectus incorporates by reference important business and financial information that we
file with the Securities and Exchange Commission and that we are not including in or delivering
with this prospectus. As the SEC allows, incorporated documents are considered part of this
prospectus, and we can disclose important information to you by referring you to those documents.
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our annual report on Form 10-K for the fiscal year ended June 30,
2008, filed on August 29, 2008; |
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portions of our definitive Proxy Statement for the Annual Meeting of
Shareholders held on October 17, 2008 that have been incorporated by
reference into the Form 10-K; |
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our quarterly report on Form 10-Q for the quarter ended September 30,
2008, filed on November 7, 2008; and |
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our current reports on Form 8-K filed with the SEC on August 27, 2008,
October 23, 2008 and October 29, 2008. |
We also incorporate by reference all documents filed with the SEC under Sections 13(a), 13(c),
14 or 15(d) of the Securities Exchange Act of 1934 after the date of this prospectus and prior to
the completion or termination of this offering. Information in this prospectus supersedes related
information in the documents listed above, and information in subsequently filed documents
supersedes related information in both this prospectus and the incorporated documents.
You may request a copy of any or all of these filings, at no cost, by writing or telephoning
us at: Aastrom Biosciences, Inc., 24 Frank Lloyd Wright Drive, P.O. Box 276, Ann Arbor, Michigan
48106, attention: Investor Relations. These filings may also be obtained through the Companys
website located at http://www.aastrom.com.
You should rely only on the information incorporated by reference or provided in this
prospectus or any supplement. We have not authorized anyone else to provide you with different
information. You should not assume that information in this prospectus or any supplement is
accurate as of any date other than the date on the front of these documents.
In accordance with these rules, we have incorporated by reference the description of our
business, our securities, our properties, any legal proceedings, market price of and dividends
with respect to our common stock, our financial statements and our managements discussion and
analysis of our financial condition and results of operations. We have also incorporated by
reference disclosure with respect to our officers and directors, their compensation structure, any
related transactions with our officers and directors and our shareholders
The Company advises that there have been no material changes in the Companys affairs that
have occurred since the end of the latest fiscal year for which audited financial statements
were included in the latest Form 10-K and that have not been described in a Form 10-Q or Form
8-K filed under the Exchange Act.
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FORWARD-LOOKING STATEMENTS
This prospectus, including the documents that we incorporate by reference, contain
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.
Because the factors referred to in the preceding paragraph could cause actual results or
outcomes to differ materially from those expressed in any forward-looking statements we make, you
should not place undue reliance on any such forward-looking statements. Further, any
forward-looking statement speaks only as of the date on which it is made, and we undertake no
obligation to update any forward-looking statement or statements to reflect events or circumstances
after the date on which such statement is made or to reflect the occurrence of unanticipated
events. New factors emerge from time to time, and it is not possible for us to predict which
factors will arise. In addition, we cannot assess the impact of each factor on our business or the
extent to which any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements. These forward-looking statements
include statements regarding:
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potential strategic collaborations with others; |
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future capital needs; |
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adequacy of existing capital to support operations for a specified time; |
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product development and marketing plan; |
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clinical trial plans and anticipated results; |
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anticipation of future losses; |
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replacement of manufacturing sources; |
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commercialization plans; and |
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revenue expectations and operating results. |
The information contained in this Prospectus, as well as in our SEC filings, identifies
important factors that could adversely affect actual results and performance. Prospective
investors are urged to carefully consider such factors.
All forward-looking statements attributable to us are expressly qualified in their entirety by
the foregoing cautionary statements.
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USE OF PROCEEDS
This prospectus relates to shares of our common stock that may be offered and sold from time
to time by the selling shareholder. We will receive no proceeds from the sale of shares of common
stock in this offering. However, we may receive up to $15.0 million in proceeds from the sale of
our common stock to Fusion Capital under the Purchase Agreement. Any proceeds from Fusion Capital
we receive under the Purchase Agreement will be used to conduct operations and continue to conduct
our clinical development programs.
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THE FUSION TRANSACTION
General
On October 27, 2008, we entered into a Common Stock Purchase Agreement with Fusion Capital
Fund II, LLC, an Illinois limited liability company. Under the Purchase Agreement, Fusion Capital
is obligated, under certain conditions, to purchase shares from us in an aggregate amount of $15.0
million from time to time over a 25-month period. Under the terms of the Purchase Agreement,
Fusion Capital has received a commitment fee consisting of 1,936,317 shares of our common stock.
Also, we will issue to Fusion Capital an additional 1,936,317 shares as a commitment fee pro rata
as we receive the $15.0 million of future funding. As of October 27, 2008, there were 132,826,495
shares outstanding (132,668,795 shares held by non-affiliates) excluding the 22,692,665 shares
offered by Fusion Capital pursuant to this Prospectus which it has not yet purchased from us. If
all of such 22,692,665 shares offered hereby were issued and outstanding as of the date hereof, the
22,692,665 shares would represent 17.1% of the total common stock outstanding or 17.1% of the
non-affiliates shares outstanding as of the date hereof.
Under the Purchase Agreement and the Registration Rights Agreement we are required to register
and have included in the offering pursuant to this Prospectus (1) 1,936,317 shares which have
already been issued, (2) an additional 1,936,317 shares which we may issue in the future as a
commitment fee pro rata as we receive the $15.0 million of future funding and (3) at least
22,692,665 shares which we may sell to Fusion Capital after this registration statement is declared
effective. All 26,565,299 shares, 20% of our outstanding on October 27, 2008, the date of The
Purchase Agreement, are being offered pursuant to this Prospectus. Under the Purchase Agreement,
we have the right but not the obligation to sell more than the 22,692,665 shares to Fusion Capital.
As of the date hereof, we do not currently have any plans or intent to sell to Fusion Capital any
shares beyond the 22,692,665 shares offered hereby. However, if we elect to sell more than the
22,692,665 shares (which we have the right but not the obligation to do), we must first register
under the Securities Act any additional shares we may elect to sell to Fusion Capital before we can
sell such additional shares, which could cause substantial dilution to our shareholders. In
addition, in the event that we decide to issue more than 26,565,299, i.e. greater than 19.99% of
our outstanding shares of common stock as of the date of the Purchase Agreement, we would first be
required to seek shareholder approval in order to be in compliance with the Nasdaq Capital Market
rules. The number of shares ultimately offered for sale by Fusion Capital is dependent upon the
number of shares purchased by Fusion Capital under the Purchase Agreement.
We do not have the right to commence any sales of our shares to Fusion Capital until the SEC
has declared effective the registration statement of which this Prospectus is a part. After the
SEC has declared effective such registration statement, generally we have the right but not the
obligation from time to time to sell our shares to Fusion Capital in amounts between $60,000 and
$2.0 million depending on certain conditions. We have the right to control the timing and amount
of any sales of our shares to Fusion Capital. The purchase price of the shares will be determined
based upon the market price of our shares without any fixed discount at the time of each sale.
Fusion Capital shall not have the right nor the obligation to purchase any shares of our common
stock on any business day that the price of our common stock is below $0.10. There
are no negative covenants, restrictions on future fundings, penalties or liquidated damages in
the Purchase Agreement or the Registration Rights Agreement. The Purchase Agreement may be
terminated by us at any time at our discretion without any cost to us. The Purchase Agreement
provides that neither party has the ability to amend the Purchase Agreement and the obligations of
both parties are non-transferable.
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Purchase Of Shares Under The Purchase Agreement
Under the Purchase Agreement, on any business day selected by us, we may direct Fusion Capital
to purchase up to $60,000 of our common stock. The purchase price per share is equal to the lesser
of:
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the lowest sale price of our common stock on the purchase date; or |
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the average of the 3 lowest closing sale prices of our common stock
during the 12 consecutive business days prior to the date of a
purchase by Fusion Capital. |
The purchase price will be equitably adjusted for any reorganization, recapitalization,
non-cash dividend, stock split, or other similar transaction occurring during the business days
used to compute the purchase price. We may direct Fusion Capital to make multiple purchases from
time to time in our sole discretion; no sooner then every other business day.
Our Right To Increase the Amount to be Purchased
In addition to purchases of up to $60,000 from time to time, we may also from time to time
elect on any single business day selected by us to require Fusion Capital to purchase our shares in
an amount up to $100,000 provided that our share price is not below $0.25 during the 3 business
days prior to and on the purchase date. We may increase this amount to up to $250,000 if our share
price is not below $0.40 during the 3 business days prior to and on the purchase date. This amount
may also be increased to up to $500,000 if our share price is not below $0.80 during the 3 business
days prior to and on the purchase date. This amount may also be increased to up to $1.0 million if
our share price is not below $1.60 during the 3 business days prior to and on the purchase date.
This amount may also be increased to up to $2.0 million if our share price is not below $2.50
during the 3 business days prior to and on the purchase date. We may direct Fusion Capital to make
multiple large purchases from time to time in our sole discretion; however, at least 1 business day
must have passed since the most recent large purchase was completed. The price at which our common
stock would be purchased in this type of larger purchase will be the lesser of (i) the lowest sale
price of our common stock on the purchase date and (ii) the lowest purchase price (as described
above) during the previous 10 business days prior to the purchase date.
Minimum Purchase Price
Under the Purchase Agreement, we have set a minimum purchase price (floor price) of $0.10.
However, Fusion Capital shall not have the right nor the obligation to purchase any shares of our
common stock in the event that the purchase price would be less the floor price. Specifically,
Fusion Capital shall not have the right or the obligation to purchase shares of our common stock on
any business day that the market price of our common stock is below $0.10.
21
Events of Default
Generally, Fusion Capital may terminate the Purchase Agreement without any liability or
payment to the Company upon the occurrence of any of the following events of default:
|
|
|
the effectiveness of the registration statement of which this prospectus is a
part of lapses for any reason (including, without limitation, the issuance of a stop
order) or is unavailable to Fusion Capital for sale of our common stock offered hereby
and such lapse or unavailability continues for a period of 10 consecutive business days
or for more than an aggregate of 30 business days in any 365-day period; |
|
|
|
|
suspension by our principal market of our common stock from trading for a
period of 3 consecutive business days; |
|
|
|
|
the de-listing of our common stock from our principal market provided our
common stock is not immediately thereafter trading on the OTC Bulletin Board Market,
the Nasdaq Global Market, the NYSE Alternext US, or the New York Stock Exchange; |
|
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|
|
the transfer agents failure for 5 business days to issue to Fusion Capital shares of our common stock which Fusion Capital is entitled to under the Purchase
Agreement; |
|
|
|
|
any material breach of the representations or warranties or covenants contained
in the Purchase Agreement or any related agreements which has or which could have a
material adverse effect on us subject to a cure period of 5 business days; or |
|
|
|
|
any participation or threatened participation in insolvency or bankruptcy
proceedings by or against us; |
|
|
|
|
a material adverse change in our business; or |
|
|
|
|
the issuance of more than an aggregate of 26,565,299 shares to Fusion Capital
under the Purchase Agreement if we fail to obtain the requisite shareholder approval. |
Our Termination Rights
We have the unconditional right at any time for any reason to give notice to Fusion Capital
terminating the Purchase Agreement without any cost to us.
No Short-Selling or Hedging by Fusion Capital
Fusion Capital has agreed that neither it nor any of its affiliates shall engage in any direct
or indirect short-selling or hedging of our common stock during any time prior to the termination
of the Purchase Agreement.
22
Effect of Performance of the Purchase Agreement on Our Stockholders
All 26,565,299 shares registered in this offering are expected to be freely tradable. It is
anticipated that shares registered in this offering will be sold over a period of up to 25 months
from the date of this prospectus. The sale by Fusion Capital of a significant amount of shares
registered in this offering at any given time could cause the market price of our common stock to
decline and to be highly volatile. Fusion Capital may ultimately purchase all, some or none of the
26,565,299 shares of common stock not yet issued but registered in this offering. After it has
acquired such shares, it may sell all, some or none of such shares. Therefore, sales to Fusion
Capital by us under the Purchase Agreement may result in substantial dilution to the interests of
other holders of our common stock. However, we have the right to control the timing and amount of
any sales of our shares to Fusion Capital and the Purchase Agreement may be terminated by us at any
time at our discretion without any cost to us.
In connection with entering into the Purchase Agreement, we authorized the sale to Fusion
Capital of up to 22,692,665 shares of our common stock (17.1% of our outstanding on October 27,
2008 the date of the Purchase Agreement). We estimate that we will sell no more than 22,692,665
shares to Fusion Capital under the Purchase Agreement (exclusive of the 1,936,317 shares issued to
Fusion Capital as the commitment fee and 1,936,317 shares which we may issue in the future as a
commitment fee pro rata as we receive the $15.0 million), all of which are included in this
offering. We have the right to terminate the Purchase Agreement without any payment or liability
to Fusion Capital at any time, including in the event that all 22,692,665 shares are sold to Fusion
Capital under the Purchase Agreement. Subject to approval by our board of directors, we have the
right but not the obligation to sell more than 22,692,665 shares to Fusion Capital. In the event
we elect to sell more than the 22,692,665 shares offered hereby, we will be required to file a new
registration statement and have it declared effective by the U.S. Securities & Exchange Commission.
In addition, in the event that we decide to issue more than 26,565,299 shares, i.e. greater than
19.99% of our outstanding shares of common stock as of the date of the Purchase Agreement, we would
first be required to seek shareholder approval in order to be in compliance with the Nasdaq Capital
Market rules. The number of shares ultimately offered for sale by Fusion Capital under this
prospectus is dependent upon the number of shares purchased by Fusion Capital under the Purchase
Agreement. The following table sets forth the amount of proceeds we would receive from Fusion
Capital from the sale of shares at varying purchase prices:
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of Outstanding |
|
Proceeds from the Sale of Shares |
|
|
|
|
Number of Shares to |
|
Shares After Giving Effect to |
|
to Fusion Capital Under the |
Assumed Average |
|
be Issued if Full |
|
the Issuance to Fusion |
|
Common Stock Purchase |
Purchase Price |
|
Purchase |
|
Capital(1) |
|
Agreement |
$ |
0.25 |
|
|
|
22,692,665 |
|
|
|
16.03 |
% |
|
$ |
5,673,166 |
|
|
|
$ |
0.40 |
|
|
|
22,692,665 |
|
|
|
16.27 |
% |
|
$ |
9,077,066 |
|
|
|
$ |
0.50 |
|
|
|
22,692,665 |
|
|
|
16.42 |
% |
|
$ |
11,346,332 |
|
|
|
$ |
0.63 |
(2) |
|
|
22,692,665 |
|
|
|
16.62 |
% |
|
$ |
14,296,379 |
|
|
|
$ |
0.66 |
|
|
|
22,692,665 |
|
|
|
16.67 |
% |
|
$ |
14,977,159 |
|
|
|
$ |
0.75 |
|
|
|
20,000,000 |
|
|
|
15.23 |
% |
|
$ |
15,000,000 |
|
|
|
$ |
1.00 |
|
|
|
15,000,000 |
|
|
|
12.44 |
% |
|
$ |
15,000,000 |
|
|
|
|
|
|
(1) |
|
The denominator is based on 134,762,812 shares outstanding as of October 27, 2008, which
includes the 1,936,317 shares previously issued to Fusion Capital, an additional pro rata
amount of the 1,936,317 shares which we will issue in the future as a commitment fee as we
receive future funding and the number of shares set forth in the adjacent column. The
numerator is based on the number of shares issuable under the Purchase Agreement at the
corresponding assumed purchase price set forth in the adjacent column. |
|
(2) |
|
Closing sale price of our shares on November 3, 2008. |
23
THE SELLING STOCKHOLDER
The following table presents information regarding the selling stockholder. Neither the
selling stockholder nor any of its affiliates has held a position or office, or had any other
material relationship, with us.
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|
|
|
|
|
|
|
|
|
|
Shares |
|
Percentage of |
|
Shares to be Sold in the Offering |
|
Percentage of |
|
|
Beneficially |
|
Outstanding Shares |
|
Assuming The Company Issues The |
|
Outstanding Shares |
|
|
Owned Before |
|
Beneficially Owned |
|
Maximum Number of Shares |
|
Beneficially Owned After |
Selling Stockholder |
|
Offering |
|
Before Offering (1) |
|
Under the Purchase Agreement (1) |
|
Offering |
Fusion Capital Fund
II, LLC (2)
|
|
|
2,014,780 |
(3) |
|
|
1.5 |
% |
|
|
26,565,299 |
|
|
* |
|
|
|
* |
|
Less than 1%. |
|
(1) |
|
Applicable percentage of ownership is based on 132,826,495 shares of our common stock
outstanding as of October 27, 2008, together with securities exercisable or convertible into
shares of Common Stock within 60 days of October 27, 2008 for the selling stockholder.
Beneficial ownership is determined in accordance with the rules of the SEC and generally
includes voting or investment power with respect to securities. Shares of common stock are
deemed to be beneficially owned by the person holding such securities for the purpose of
computing the percentage of ownership of such person, but are not treated as outstanding for
the purpose of computing the percentage ownership of any other person. |
|
(2) |
|
Steven G. Martin and Joshua B. Scheinfeld, the principals of Fusion Capital, are deemed to be
beneficial owners of all of the shares of common stock owned by Fusion Capital. Messrs.
Martin and Scheinfeld have shared voting and disposition power over the shares being offered
under this Prospectus. |
|
(3) |
|
As of the date hereof, 2,014,780 shares of our common stock have been previously acquired by
Fusion Capital, consisting of 1,936,317 shares we issued to Fusion Capital as a commitment fee
and 78,463 shares that were owned prior to the Purchase Agreement. The Company may elect in
its sole discretion to sell to Fusion Capital up to an additional 22,692,665 shares under the
Purchase Agreement and an additional 1,936,317 shares may be issued in the future as a
commitment fee pro rata as we receive the $15.0 million of future funding. Fusion Capital
does not presently beneficially own those shares as determined in accordance with the rules of
the SEC. |
24
PLAN OF DISTRIBUTION
The common stock offered by this prospectus is being offered by Fusion Capital Fund II, LLC,
the selling shareholder. The common stock may be sold or distributed from time to time by the
selling stockholder directly to one or more purchasers or through brokers, dealers, or underwriters
who may act solely as agents at market prices prevailing at the time of sale, at prices related to
the prevailing market prices, at negotiated prices, or at fixed prices, which may be changed. The
sale of the common stock offered by this Prospectus may be effected in one or more of the following
methods:
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ordinary brokers transactions; |
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transactions involving cross or block trades; |
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through brokers, dealers, or underwriters who may act solely as agents |
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at the market into an existing market for the common stock; |
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in other ways not involving market makers or established business markets,
including direct sales to purchasers or sales effected through agents; |
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in privately negotiated transactions; or |
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any combination of the foregoing. |
In order to comply with the securities laws of certain states, if applicable, the shares may
be sold only through registered or licensed brokers or dealers. In addition, in certain states,
the shares may not be sold unless they have been registered or qualified for sale in the state or
an exemption from the registration or qualification requirement is available and complied with.
Brokers, dealers, underwriters, or agents participating in the distribution of the shares as
agents may receive compensation in the form of commissions, discounts, or concessions from the
selling shareholder and/or purchasers of the common stock for whom the broker-dealers may act as
agent. The compensation paid to a particular broker-dealer may be less than or in excess of
customary commissions.
Fusion Capital is an underwriter within the meaning of the Securities Act.
Neither we nor Fusion Capital can presently estimate the amount of compensation that any agent
will receive. We know of no existing arrangements between Fusion Capital, any other shareholder,
broker, dealer, underwriter, or agent relating to the sale or distribution of the shares offered by
this Prospectus. At the time a particular offer of shares is made, a prospectus supplement, if
required, will be distributed that will set forth the names of any agents, underwriters, or dealers
and any compensation from the selling shareholder, and any other required information.
We will pay all of the expenses incident to the registration, offering, and sale of the shares
to the public other than commissions or discounts of underwriters, broker-dealers, or agents. We
have also agreed to indemnify Fusion Capital and related persons against specified liabilities,
including liabilities under the Securities Act.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to our directors, officers, and controlling persons, we have been advised that in the opinion of
the
SEC this indemnification is against public policy as expressed in the Securities Act and is
therefore, unenforceable.
25
Fusion Capital and its affiliates have agreed not to engage in any direct or indirect short
selling or hedging of our common stock during the term of the Purchase Agreement.
We have advised Fusion Capital that while it is engaged in a distribution of the shares
included in this Prospectus it is required to comply with Regulation M promulgated under the
Securities Exchange Act of 1934, as amended. With certain exceptions, Regulation M precludes the
selling shareholder, any affiliated purchasers, and any broker-dealer or other person who
participates in the distribution from bidding for or purchasing, or attempting to induce any person
to bid for or purchase any security which is the subject of the distribution until the entire
distribution is complete. Regulation M also prohibits any bids or purchases made in order to
stabilize the price of a security in connection with the distribution of that security. All of the
foregoing may affect the marketability of the shares offered hereby this Prospectus.
This offering will terminate on the date that all shares offered by this Prospectus have been
sold by Fusion Capital.
26
LEGAL MATTERS
The validity of the common stock offered by this Prospectus will be passed upon for us by
Dykema Gossett PLLC, Ann Arbor, Michigan, acting as special counsel to the Company.
EXPERTS
The financial statements and managements assessment of the effectiveness of internal control
over financial reporting (which is included in Managements Report on Internal Control over Financial
Reporting) incorporated in this Prospectus by reference to the Annual Report on Form 10-K for the
year ended June 30, 2008 have been so incorporated in reliance on the report of
PricewaterhouseCoopers LLP, an independent registered public accounting firm, given on the authority
of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We
have filed with the Securities and Exchange Commission a registration
statement on Form S-3
under the Securities Act of 1933, relating to the shares of our common stock being offered by this
prospectus. For further information pertaining to our common stock and the shares of common stock
being offering by this prospectus, reference is made to such registration statement. This
prospectus constitutes the prospectus we filed as a part of the registration statement and it does
not contain all information in the registration statement, certain portions of which have been
omitted in accordance with the rules and regulations of the Securities and Exchange Commission and
certain portions of which have been incorporated by reference to our reports filed with the
Securities and Exchange Commission.
In addition, we are subject to the informational requirements of the Securities Exchange Act
of 1934, as amended, and, in accordance with such requirements, we file reports, proxy statements
and other information with the Securities and Exchange Commission relating to our business,
financial statements and other matters.
Reports and proxy and information statements filed under Section 14(a) and 14(c) of the
Securities Exchange Act of 1934 and other information filed with the Securities and Exchange
Commission as well as copies of the registration statement can be inspected and copied at the
public reference facilities maintained by the Securities and Exchange Commission at Room 1024,
Judiciary Plaza, 100 F Street, N.E., Washington, D.C. 20549. Copies of such material can also be
obtained at prescribed rates from the Public Reference Section of the Securities and Exchange
Commission at its principal office at Judiciary Plaza, 100 F Street, N.E., Washington, D.C. 20549.
Please call the Securities and Exchange Commission at 1.800.SEC.0330 for further information on
the operation of the public reference room. Such material may also be obtained electronically by
visiting the SECs web site on the Internet at http://www.sec.gov. Our common stock is traded on
the Nasdaq Capital Market under the symbol ASTM.
Copies of our filings with the Securities and Exchange Commission are also available, free of
charge, on our corporate website at http://www.aastrom.com. The other information found on our
website is not incorporated by reference into this prospectus.
27
You should rely only on the information contained in this Prospectus or the documents
incorporated by reference. Neither we nor the selling shareholder has authorized anyone to provide
you with any information that is different from that contained in this Prospectus. The information
contained in this Prospectus is accurate as of the date of this Prospectus. You should not assume
that there have been no changes in the affairs of the Company since the date of this Prospectus or
that the information in this Prospectus is correct as of any time after the date of this
Prospectus, regardless of the time that this Prospectus is delivered or any sale of the common
stock offered by this Prospectus is made. This Prospectus is not an offer to sell or a
solicitation of an offer to buy the shares covered by this Prospectus in any jurisdiction where the
offer or solicitation is unlawful.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
As
permitted by the Michigan Business Corporation Act, our Bylaws contain provisions that permit us to indemnify our directors and officers to the full
extent permitted by Michigan law and our Restated Articles of
Incorporation, as amended, contain provisions that eliminate the personal liability
of our directors in each case
for monetary damages to us or our shareholders for breach of their fiduciary duties, except to the
extent that Michigan law prohibits indemnification or elimination of liability. These provisions do
not limit or eliminate our rights or the rights of any shareholder to seek an injunction or any
other non-monetary relief in the event of a breach of a directors or officers fiduciary duty. In
addition, these provisions apply only to claims against a director or officer arising out of his or
her role as a director or officer and do not relieve a director or officer from liability if he or
she engaged in willful misconduct or a knowing violation of the criminal law or any federal or
state securities law.
The
rights of indemnification provided in our Bylaws
are not exclusive of any other rights that may be available under any insurance or other agreement,
by vote of shareholders or disinterested directors or otherwise.
Insofar as indemnification for liabilities arising under the Securities Act of 1933, as
amended (the Securities Act), may be permitted to directors, officers or persons controlling us
pursuant to the foregoing provisions, we have been informed that in the opinion of the Securities
and Exchange Commission this type of indemnification is against public policy as expressed in the
Securities Act and is therefore unenforceable.
28
No dealer, salesperson, or other person has been authorized to give any information or to make
any representation not contained in this Prospectus, and, if given or made, such information and
representation should not be relied upon as having been authorized by Aastrom Biosciences, Inc. or
the selling shareholder. This Prospectus does not constitute an offer to sell or a solicitation of
an offer to buy any of the securities offered by this Prospectus in any jurisdiction or to any
person to whom it is unlawful to make such offer or solicitation. Neither the delivery of this
Prospectus nor any sale made hereunder shall under any circumstances create an implication that
there has been no change in the facts set forth in this Prospectus or in the affairs of Aastrom
Biosciences, Inc. since the date hereof.
26,565,299 SHARES
AASTROM BIOSCIENCES, INC.
COMMON STOCK
PROSPECTUS
November 10, 2008
29
Part IIINFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The expenses payable by the Registrant in connection with the issuance and distribution of the
securities being registered (other than underwriting discounts and commissions, if any) are set
forth below. Each item listed is estimated, except for the Securities and Exchange Commission
registration fee and the American Stock Exchange additional listing fee.
|
|
|
|
|
Securities and Exchange Commission registration fee |
|
$ |
517 |
|
Nasdaq Stock Market additional listing fees |
|
|
26,500 |
|
Accounting fees and expenses |
|
|
18,000 |
|
Legal fees and expenses |
|
|
45,000 |
|
Registrar and transfer agents fees and expenses |
|
|
5,000 |
|
Printing and engraving expenses |
|
|
2,500 |
|
Miscellaneous |
|
|
2,483 |
|
|
|
|
|
Total expenses |
|
|
100,000 |
|
|
|
|
|
Item 15. Indemnification of Directors and Officers
Sections 1561 through 1571 of the Michigan Business Corporation Act (the MBCA) authorize a
corporation to grant or a court to award, indemnity to directors, officers, employees and agents in
terms sufficiently broad to permit such indemnification under certain circumstances for liabilities
(including reimbursement for expenses incurred) arising under the Securities Act of 1933.
The Bylaws of the Company provide that the Company shall, to the fullest extent authorized or
permitted by the MBCA, or other applicable law, indemnify a director or officer who was or is a
party or is threatened to be made a party to any proceeding by or in the right of the Company to
procure a judgment in its favor by reason of the fact that such person is or was a director,
officer, employee or agent of the Company, against expenses, including actual and reasonable
attorneys fees, and amounts paid in settlement incurred in connection with the action or suit, if
the indemnitee acted in good faith and in a manner the person reasonably believed to be in, or not
opposed to, the best interests of the Company or its shareholders. This section also authorizes the
Company to advance expenses incurred by any agent of the Company in defending any proceeding prior
to the final disposition of such proceeding upon receipt of an undertaking by or on behalf of the
agent to repay such amount unless it shall be determined ultimately that the agent is entitled to
be indemnified.
The Bylaws also authorize the Company to purchase and maintain insurance on behalf of any
person who is or was a director, officer, employee or agent of the Company against any liability
asserted against or incurred by such person in such capacity or arising out of such persons status
as such, regardless of whether the Company would have the power to indemnify such person against
such liability under the provisions of the MBCA.
II-1
The Company has entered into indemnification agreements with certain individuals which contain
provisions that may in some respects be broader than the specific indemnification provisions
contained under applicable law. The indemnification agreement may require the
Company, among other things, to indemnify such directors, officers and key personnel against
certain liabilities that may arise by reason of their status or service as directors, officers or
employees of the Company, to advance the expenses incurred by such parties as a result of any
threatened claims or proceedings brought against them as to which they could be indemnified, and to
the maximum extent that insurance coverage of such directors, officers and key employees under the
Companys directors and officers liability insurance policies is maintained.
Section 1209 of the MBCA permits a Michigan corporation to include in its Articles of
Incorporation a provision eliminating or limiting a directors liability to a corporation or its
shareholders for monetary damages for breaches of fiduciary duty. The enabling statute provides,
however, that liability for breaches of the duty of loyalty, acts or omissions not in good faith or
involving intentional misconduct or knowing violations of the law, or the receipt of improper
personal benefits cannot be eliminated or limited in this manner. The Companys Restated Articles
of Incorporation include a provision which eliminates, to the fullest extent permitted by the MBCA,
director liability for monetary damages for breaches of fiduciary duty.
Item 16. Exhibits
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Exhibit |
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No. |
|
Description |
|
|
|
3.1
|
|
Restated Articles of Incorporation of Aastrom, as amended, attached as Exhibit 3.1 to
Aastroms Current Report on Form 8-K filed on October 23, 2008, incorporated herein by
reference. |
|
|
|
3.2
|
|
Bylaws, as amended, attached as Exhibit 3.2 to Aastroms Current Report on
Form 8-K filed on October 23, 2008, incorporated herein by reference. |
|
|
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5
|
|
Opinion of Dykema Gossett PLLC. |
|
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|
10.1
|
|
Form of Indemnification Agreement, attached as Exhibit 10.1 to Aastroms Registration
Statement on Form S-1 (No. 333-15415), filed on November 1, 1996, incorporated herein by
reference. |
|
|
|
10.2#
|
|
Amended and Restated 1992 Incentive and Non-Qualified Stock Option Plan and forms of
agreements thereunder, attached as Exhibit 10.5 to Aastroms Registration Statement on
Form S-1 (No. 333-15415), filed on November 1, 1996, incorporated herein by reference. |
|
|
|
10.3#
|
|
Form of Employment Agreement, attached as Exhibit 10.8 to Aastroms Registration Statement
on Form S-1 (No. 333-15415), filed on November 1, 1996, incorporated herein by reference. |
|
|
|
10.4
|
|
License Agreement, dated July 17, 1992, between J.G. Cremonese and Aastrom and related
addenda thereto dated July 14, 1992 and July 7, 1993, attached as Exhibit 10.11 to Aastroms
Registration Statement on Form S-1 (No. 333-15415), filed on November 1, 1996, incorporated
herein by reference. |
II-2
|
|
|
Exhibit |
|
|
No. |
|
Description |
|
|
|
10.5
|
|
License Agreement, dated March 13, 1992, between Aastrom and the University of Michigan and
amendments thereto dated March 13, 1992, October 8, 1993 and June 21, 1995, attached as
Exhibit 10.17 to Aastroms Registration Statement on Form S-1 (No. 333-15415), filed on
November 1, 1996, incorporated herein by reference. |
|
|
|
10.6#
|
|
Aastrom Biosciences 2001 Stock Option Plan, attached as Exhibit 10.72 to Aastroms Annual
Report on Form 10-K for the year ended June 30, 2002, incorporated herein by reference. |
|
|
|
10.7
|
|
Master Supply Agreement with Astro Instrumentation, LLC, attached as Exhibit 10.76 to
Aastroms Annual Report on Form 10-K for the year ended June 30, 2003, incorporated herein by
reference. |
|
|
|
10.8
|
|
Supply Agreement between Aastrom and Moll Industries, Inc., dated December 16, 2003, attached
as Exhibit 10.77 to Aastroms Annual Report on Form 10-K for the year ended June 30, 2004,
incorporated herein by reference. |
|
|
|
10.9#
|
|
2004 Equity Incentive Plan, attached as Exhibit 10.82 to Amendment No. 1 to Aastroms
Quarterly Report on Form 10-Q/A for the quarter ended September 30, 2004, incorporated herein
by reference. |
|
|
|
10.10#
|
|
Form of Option and Restricted Stock Award Agreements for Grants under 2004 Equity Incentive
Plan, attached as Exhibit 10.84 to Aastroms Annual Report on Form 10-K for the year ended
June 30, 2005, incorporated herein by reference. |
|
|
|
10.11#
|
|
Employee Compensation Guidelines, attached as Exhibit 10.85 to Aastroms Annual Report on
Form 10-K for the year ended June 20, 2005, incorporated herein by reference. |
|
|
|
10.12#
|
|
Employment Agreement with Gerald D. Brennan, Jr. dated June 10, 2005, attached as
Exhibit 10.86 to Aastroms Annual Report on Form 10-K for the year ended June 30, 2005,
incorporated herein by reference. |
|
|
|
10.13
|
|
Amendment dated December 5, 2002 to License Agreement with the University of Michigan,
attached as Exhibit 10.87 to Aastroms Annual Report on Form 10-K for the year ended June 30,
2005, incorporated herein by reference. |
|
|
|
10.14#
|
|
Employment Agreement with George W. Dunbar dated July 17, 2006, attached as Exhibit 99.1 to
Aastroms Current Report on Form 8-K filed on July 18, 2006, incorporated herein by reference. |
|
|
|
10.15#
|
|
Summary of Changes to Employee Compensation Guidelines, attached as Exhibit 10.94 to
Aastroms Quarterly Report on Form 10-Q for the quarter ended December 31, 2006, incorporated
herein by reference. |
II-3
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Exhibit |
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No. |
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Description |
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10.16#
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2004 Equity Incentive Plan, as amended, attached as Exhibit 99.1 to Aastroms Current Report
on Form 8-K filed on November 8, 2006, incorporated herein by reference. |
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10.17#
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Forms of Grant Notice and Stock Option Agreement for Grants under 2004 Equity Incentive
Plan, as amended, attached as Exhibit 99.2 to Aastroms Current Report on Form 8-K filed on
November 8, 2006, incorporated herein by reference. |
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10.18
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Placement Agency Agreement, dated October 15, 2007, by and between the Company and BMO
Capital Markets Corp., attached as Exhibit 10.1 to Aastroms Current Report on Form 8-K filed
on October 16, 2007, incorporated herein by reference. |
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10.19
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Escrow Agreement, dated as of October 15, 2007, among the Company, BMO Capital Markets Corp.
and The Bank of New York, attached as Exhibit 10.2 to Aastroms Current Report on Form 8-K
filed on October 16, 2007, incorporated herein by reference. |
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10.20
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Form of Purchase Agreement, attached as Exhibit 10.3 to Aastroms Current Report on Form 8-K
filed on October 16, 2007, incorporated herein by reference. |
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10.21
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Form of Warrant, attached as Exhibit 10.2 to Aastroms Current Report on Form 8-K filed on
October 16, 2007, incorporated herein by reference. |
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10.22
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Standard Lease between Aastrom and Dominos Farms Office Park, L.L.C. dated January 31,
2007, attached as Exhibit 10.96 to Amendment No. 2 to Aastroms Annual Report on Form 10-K for
the year ended June 30, 2007, incorporated herein by reference. |
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10.23#
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Nonemployee Director Compensation Guidelines, attached as Exhibit 10.98 to Aastroms
Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, incorporated herein by
reference. |
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10.24#
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Amendment to Employment Agreement, dated March 10, 2008, between Aastrom Biosciences, Inc.
and Gerald D. Brennan, Jr., attached as Exhibit 10.99 to Aastroms Quarterly Report on
Form 10-Q for the quarter ended March 31, 2008, incorporated herein by reference. |
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10.25
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Common Stock Purchase Agreement between Aastrom and Fusion Capital Fund II, LLC dated
October 27, 2008, attached as Exhibit 10.1 to Aastroms Form 8-K dated October 29, 2008,
incorporated herein by reference. |
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10.26
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Registration Rights Agreement between Aastrom and Fusion Capital Fund II, LLC dated October
27, 2008, attached as Exhibit 10.2 to Aastroms Form 8-K dated October 29, 2008, incorporated
herein by reference. |
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21
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Subsidiaries of Registrant. |
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23
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Consent of Independent Registered Public Accounting Firm. |
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24
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Powers of Attorney (included on signature page). |
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# |
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Management contract or compensatory plan or arrangement covering executive officers or
directors of Aastrom. |
II-4
Item 17. Undertakings
(a) The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of the
registration statement (or the most recent post-effective amendment thereof) which, individually or
in the aggregate, represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and
any deviation from the low or high end of the estimated maximum offering range may be reflected in
the form of prospectus filed with the Commission pursuant to Rule 424(b) (§ 230.424(b) of this
chapter) if, in the aggregate, the changes in volume and price represent no more than a 20% change
in the maximum aggregate offering price set forth in the Calculation of Registration Fee table in
the effective registration statement.
(iii) To include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to such information in
the registration statement;
Provided, however, That:
(A) Paragraphs (a)(1)(i) and (a)(1)(ii) of this section do not apply if the registration
statement is on Form S-8 (§ 230. 16b of this chapter), and the information required to be included
in a post-effective amendment by those paragraphs is contained in reports filed with or furnished
to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Securities
Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)) that are incorporated by reference in this
registration statement; and
(B) Paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section do not apply if the
registration statement is on Form S-3 (§ 239.13 of this chapter) or Form F-3 (§ 239.33 of this
chapter) and the information required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the Commission by the Registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are
incorporated by reference in the registration statement, or is contained in a form of prospectus
filed pursuant to Rule 424(b) (§ 230.424(b) of this chapter) that is part of the registration
statement.
(C) Provided further, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not apply if the
registration statement is for an offering of asset-backed securities on Form S-1 (§ 239.11 of this
chapter) or Form S-3 (§ 239.13 of this chapter), and the information required to be included in a
post-effective amendment is provided pursuant to Item 1100(c) of Regulation AB (§ 229.1100(c)).
II-5
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(b) The undersigned Registrant hereby undertakes that, for purposes of determining any liability
under the Securities Act of 1933, each filing of the Registrants annual report pursuant to Section
13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing
of an employee benefit plans annual report pursuant to Section 15(d) of the Securities Exchange
Act of 1934) that is incorporated by reference in this registration statement shall be deemed to be
a new registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the Registrant pursuant to the
foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Act and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the Registrant of expenses incurred or paid by a
director, officer or controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with
the securities being registered, the Registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
II-6
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant has duly caused
this registration statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in Ann Arbor, Michigan on November 10, 2008.
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AASTROM BIOSCIENCES, INC. |
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By
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/s/ George W. Dunbar, Jr. |
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George W. Dunbar, Jr. |
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President and Chief Executive Officer |
Each person whose signature appears below hereby constitutes and appoints George W. Dunbar,
Jr. his true and lawful attorney-in-fact and agent, with full power of substitution and
resubstitution, for him and in his name, place and stead, in any and all capacities, to sign any or
all amendments (including, without limitation, post-effective amendments) to this Registration
Statement and any subsequent registration statement filed by the Registrant pursuant to Rule 462(b)
of the Securities Act of 1933, which relates to this Registration Statement, and to file the same,
with all exhibits thereto, and all documents in connection herewith, with the Securities and
Exchange Commission, granting unto said attorney-in-fact and agent, full power and authority to do
and perform each and every act and thing requisite and necessary to be done in and about the
premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying
and confirming all that said attorney-in-fact and agent, or his substitutes, may lawfully do or
cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has
been signed by the following persons in the capacities and on the dates indicated.
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Signature |
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Title |
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Date |
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/s/ George W. Dunbar, Jr.
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President and CEO (Principal
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November 10, 2008 |
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Executive,
Financial and
Accounting Officer) |
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/s/ Nelson M. Sims
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Chairman of the Board
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November 10, 2008 |
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/s/ Timothy M. Mayleben
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Director
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November 10, 2008 |
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/s/ Alan L. Rubino
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Director
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November 10, 2008 |
Alan L. Rubino |
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/s/ Stephen G. Sudovar
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Director
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November 10, 2008 |
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/s/ Robert L. Zerbe, M.D.
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Director
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November 10, 2008 |
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II-7
exv5
Exhibit 5
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Dykema Gossett PLLC 2723 South State Street Suite 400
Ann Arbor, Michigan 48104
www.dykema.com
Tel: (734) 214-7660
Fax: (734) 214-7696 |
November 10, 2008
Aastrom Biosciences, Inc.
Dominos Farms, Lobby K
24 Frank Lloyd Wright Drive
Ann Arbor, MI 48105
Re: Aastrom Biosciences, Inc. Registration Statement on Form S-3
Gentlemen:
As special counsel to Aastrom Biosciences, Inc., a Michigan corporation (the Company), we
are rendering this opinion in connection with the filing with the Securities and Exchange
Commission (the Commission) of the Companys registration statement on Form S-3 (the
Registration Statement), under the Securities Act of 1933, as amended (the Act). The
Registration Statement relates to the offering of up to 26,565,299 shares of the Companys Common
Stock (the Shares) by Fusion Capital Fund II, LLC, the selling shareholder named in the
Registration Statement (the Selling Shareholder). Of the total Shares covered by the
Registration Statement, (i) 1,936,317 Shares (the Initial Commitment Shares) have been issued to
the Selling Shareholder pursuant to a Common Stock Purchase Agreement dated October 27, 2008
between the Company and the Selling Shareholder (the Purchase Agreement) and (ii) 24,628,982
Shares (the Additional Shares) may be issued from time to time pursuant to the Purchase
Agreement. The Shares may be resold by the Selling Shareholder in the manner described in the
Registration Statement.
In rendering our opinion, we have examined the Registration Statement (including the exhibits
thereto), the Purchase Agreement, the originals or copies, certified or otherwise identified to
our satisfaction, of the Restated Articles of Incorporation and the Bylaws of the Company as
amended to date, resolutions of the Companys Board of Directors and such other documents and
corporate records relating to the Company and the issuance and sale of the Shares as we have deemed
appropriate.
In our examination, we have assumed the legal capacity of all natural persons, the genuineness
of all signatures, the conformity to original documents of all photostatic and facsimile copies
submitted to us, and the due execution and delivery of all documents by any party where due
execution and delivery are a prerequisite to the effectiveness thereof. We have assumed that the
Purchase Agreement is enforceable in accordance with its terms. As to any
California | Illinois | Michigan | Texas | Washington D.C.
Aastrom Biosciences, Inc.
November 10, 2008
Page 2
facts material to the opinion expressed herein that were not independently established or verified,
we have relied upon statements and representations of officers and other representatives of the
Company. We have assumed that payment and delivery of the Shares is made in accordance with the
terms set forth in the Purchase Agreement and other agreements and documents relating to the
issuance and sale of the Shares and that the terms set forth in such agreements and other documents
are in accordance with the resolutions of the Companys Board of Directors approving the issuance
and sale of the Shares. In addition, we have assumed that the certificates representing the Shares
will be duly executed and delivered.
On the basis of the foregoing, we are of the opinion that (i) the Initial Commitment Shares
are validly issued, fully paid and non-assessable; and (ii) the Additional Shares, when issued
against payment therefor in accordance with the terms of the Purchase Agreement, will be validly
issued, fully paid, and non-assessable.
The opinion expressed herein is based exclusively on the applicable provisions of the Michigan
Business Corporation Act as in effect on the date hereof.
We hereby consent to the reference to our firm under the caption Legal Matters in the
Registration Statement and to the filing of this opinion as an exhibit to the Registration
Statement. Such consent does not constitute a consent under Section 7 of the Act, since we have
not certified any part of such Registration Statement and do not otherwise come within the
categories of persons whose consent is required under Section 7 of the Act or the rules and
regulations of the Commission promulgated thereunder.
Sincerely yours,
Dykema
Gossett pllc
/s/ Dykema
Gossett pllc
tgf
California | Illinois | Michigan | Texas | Washington D.C.
exv21
EXHIBIT 21
SUBSIDIARIES OF REGISTRANT
Aastrom Biosciences, Ltd., Ireland
Aastrom Biosciences GmbH, Germany
Aastrom Biosciences SL, Spain
exv23
EXHIBIT 23
Consent of Independent Registered Public Accounting Firm
We hereby consent to the incorporation by reference in this Registration Statement on Form S-3 of
our report dated August 29, 2008 relating to the financial statements and the effectiveness of
internal control over financial reporting, which appears in Aastrom Biosciences, Inc.s Annual
Report on Form 10-K for the year ended June 30, 2008. We also consent to the references to us
under the heading Experts in such Registration Statement.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Detroit, Michigan
November 10, 2008