Aastrom
Filed Pursuant to Rule 424(b)(5)
Registration File Number. 333-123570
The information in this prospectus supplement is not complete and may be changed. The registration
statement to which this preliminary prospectus relates has been declared effective by the
Securities and Exchange Commission. This preliminary prospectus supplement and the accompanying
base prospectus are not an offer to sell these securities and they are not soliciting an offer to
buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject
to Completion, dated October 16, 2007
Preliminary Prospectus Supplement
(To Prospectus dated October 11, 2005)
Shares
Warrants to Purchase Shares
Common Stock
We are offering to unaffiliated institutional investors up to shares of our common stock
and warrants to purchase up to shares of common stock in this offering (and the shares of
common stock issuable from time to time upon exercise of these warrants). The common stock and
warrants will be sold in units, with each unit consisting of one share of common stock and a
warrant to purchase ___shares of common stock at an exercise price of $ per share of common
stock. Each unit will be sold at a negotiated price of $ per unit. Units will not be issued or
certificated. The shares of common stock and warrants are immediately separable and will be issued
separately.
Our common stock is traded on the Nasdaq Capital Market under the symbol ASTM. On October ___,
2007, the closing price of our common stock on the Nasdaq Capital
Market was $ per share.
We have retained BMO Capital Markets Corp. to act as exclusive placement agent in this offering. We
have agreed to pay BMO Capital Markets Corp. the placement agents fees set forth in the table
below. The placement agent is not required to sell any specific number or dollar amount of
securities offered in this offering, but will use their commercially reasonable efforts to arrange
for the sale of the securities offered.
Neither the Securities and Exchange Commission nor any state securities commission has approved or
disapproved of these securities or determined if this prospectus supplement or the accompanying
base prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
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Per Unit |
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Public offering price |
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Placement agents fee |
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Proceeds to Aastrom Biosciences, Inc. (before expenses) |
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We estimate the total expenses of this offering, excluding the placement agents fee, will be
approximately $150,000. Because there is no minimum offering amount required as a condition to
closing in this offering, the actual public offering amount, placement agents fee and net proceeds
to us, if any, in this offering are not presently determinable and may be substantially less than
the maximum offering amounts set forth in this prospectus supplement.
Delivery of the units to purchasers is expected to be made on or about October ___, 2007.
Investing in our securities involves significant risks. Please see the section entitled Risk
Factors beginning on page S-4 of this prospectus supplement, page 3 of the accompanying base
prospectus and page 15 of our Annual Report on Form 10-K for the fiscal year ended June 30, 2007.
BMO Capital Markets
As Placement Agent
October ___, 2007
TABLE OF CONTENTS
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Prospectus Supplement |
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S-1 |
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S-16 |
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S-16 |
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Prospectus |
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This prospectus supplement and the accompanying base prospectus, dated October 11, 2005,
relate to the offer by us of up to shares of our common stock and warrants to purchase up
to shares of common stock in this offering (and the shares of common stock issuable from
time to time upon exercise of these warrants). You should rely only on the information contained in
or incorporated by reference into this prospectus supplement and the accompanying base prospectus
and any free writing prospectuses prepared by us or on our behalf. If anyone provides you with
different or inconsistent information, you should not rely on it. We are not making an offer to
sell these securities in any jurisdiction where the offer or sale is not permitted. You should
assume that the information contained in this prospectus supplement, the accompanying base
prospectus and the documents incorporated by reference is accurate only as of their respective
dates, regardless of the time of delivery of this prospectus supplement and accompanying base
prospectus or of any sale of shares of our common stock and warrants to purchase shares of common
stock in this offering (and the shares of common stock issuable from time to time upon exercise of
these warrants). Our business, financial condition, results of operations and prospects may have
subsequently changed.
No action is being taken in any jurisdiction outside the United States to permit a public
offering of the shares of our common stock or warrants, or possession or distribution of this
prospectus supplement and the accompanying base prospectus in that jurisdiction. Persons who come
into possession of this prospectus supplement and the accompanying base prospectus in jurisdictions
outside the United States are required to inform themselves about and to observe any restrictions
as to this offering and the distribution of this prospectus supplement and the accompanying base
prospectus applicable to that jurisdiction.
i
ABOUT THIS PROSPECTUS SUPPLEMENT
This prospectus supplement and the accompanying base prospectus are part of a registration
statement on Form S-3 that we filed with the Securities and Exchange Commission, or SEC, using a
shelf registration process. Under this shelf registration process, we may offer and sell any
combination of securities described in the accompanying base prospectus in one or more offerings,
up to a total dollar amount of $75 million. We previously sold securities under this shelf
registration having an aggregate dollar amount of $25,510,000, leaving a remaining available dollar
amount of $49,490,000. The accompanying base prospectus provides you with a general description of
the securities we may offer. Each time we use the accompanying base prospectus to offer securities,
we will provide a prospectus supplement that will contain specific information about the terms of
that offering. This prospectus supplement, the accompanying base prospectus and the documents
incorporated by reference herein and therein include important information about us, our common
stock and warrants being offered and other information you should know before investing. The
prospectus supplement may also add, update or change information contained in the base prospectus.
This prospectus supplement describes the specific details regarding this offering, including the
price, the amount of common stock and warrants being offered, the risks of investing in our common
stock and warrants, and the placement arrangements. The accompanying base prospectus provides
general information about us, some of which may not apply to this offering.
Unless the context requires otherwise, in this prospectus supplement and the accompanying base
prospectus the terms Aastrom, we, us and our refer to Aastrom Biosciences, Inc. and its
subsidiaries.
To the extent that any statement that we make in this prospectus supplement is inconsistent
with statements made in the accompanying base prospectus, the statements made in this prospectus
supplement will be deemed to modify or supersede those made in the accompanying base prospectus.
You should read both this prospectus supplement and the accompanying base prospectus together with
additional information described under the heading, Where You Can Find More Information.
PROSPECTUS SUPPLEMENT SUMMARY
The following summary highlights selected information about us. Because this is a summary, it
does not contain all the information about us that may be important to you. You should read this
entire prospectus and the other documents and the financial statements and related notes which are
incorporated by reference in this prospectus.
We are a regenerative medicine company (a medical area that focuses on developing therapies
that regenerate damaged or diseased tissues or organs) focused 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 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 bone, vascular, cardiac and neural. TRC-based products
have been used in over 250 patients, and are currently in the following stages of development:
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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;
Orphan Drug Designation from the FDA for use in the treatment of
osteonecrosis of the femoral head |
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Spain: Pivotal clinical trial |
S-1
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Germany: Positive interim compassionate use
data reported in October 2007 |
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U.S.: Patient enrollment completed in Phase
I/II clinical trial; final patient results expected to be reported in
October 2007 |
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Vascular regeneration Vascular Repair Cells (VRCs): |
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Critical limb ischemia: |
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U.S.: RESTORE-CLI Phase IIb clinical trial |
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Germany: Phase I/II clinical trial;
positive interim data reported in October 2007 |
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Cardiac regeneration Cardiac Repair Cells (CRCs): |
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Preclinical research underway; clinical
program under development; Orphan Drug Designation from the FDA for
use in the treatment of dilated cardiomyopathy, a severe chronic
disease of the heart |
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Neural regeneration Neural Repair Cells (NRCs): |
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Preclinical research underway; clinical program under development |
Our platform TRC Technology is based on:
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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 |
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The means to produce these products in an automated process. |
We have developed a patented and proprietary 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 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 bone, vascular, cardiac, neural, and the
hematopoietic and immune system.
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 that time we
have phased out our marketing efforts promoting the cell manufacturing system as a commercial
product in the U.S. Currently, we have product sales consisting of limited sales of manufacturing
supplies to academic collaborators for research and limited revenue related to cell-based products.
S-2
Our current focus is on utilizing our TRC Technology to produce autologous cell-based products
for use in regenerative medicine. 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 more 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 dendritic cell and T-cell manufacturing supplies to our
academic collaborators, grant revenue, research funding and potential licensing fees or other
financial support from potential future corporate collaborators.
We are beginning to explore the possibility of entering into complementary regenerative
medicine business activities, whether through acquisition or otherwise.
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 June 30, 2007, we have accumulated a net loss of approximately $159 million. We
cannot provide any assurance that we will be able to achieve profitability on a sustained basis, if
at all, obtain the required funding, obtain the required regulatory approvals, or complete
additional corporate partnering or acquisition transactions.
Our principal executive offices are located at 24 Frank Lloyd Wright Drive, P.O. Box 376, Ann
Arbor, MI 48106. Our telephone number is (734) 930-5555.
THE OFFERING
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Securities offered
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shares of common
stock and warrants to purchase
shares of common stock |
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Common stock to be outstanding immediately
after this offering
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shares |
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Offering price
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$___ |
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Warrants:
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The warrants will be
exercisable for cash on or
after , 20___through
and including ,
20___, at an exercise price of
$ per share of common
stock. |
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Use of proceeds
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Proceeds from the offering
will be used to fund: (i) clinical trials and
research and development;
(ii) manufacturing development
and expansion; and (iii) other
working capital and general
corporate purposes. See Use
of Proceeds on page S-13. |
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The Nasdaq Capital Market Symbol
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ASTM |
The number of shares of common stock to be outstanding after this offering is based on
120,874,063 shares outstanding as of August 31, 2007, plus the shares covered by this
offering. This number excludes:
S-3
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a total of 10,837,936 shares of our common stock subject to outstanding options under our
current and previous equity incentive plans as of June 30, 2007, having a weighted average
exercise price of $1.47 per share (since June 30, 2007, an additional 1,701,200 options have
been issued at an average exercise price of $1.14 per share); |
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5,047,667 shares of our common stock issuable upon exercise of outstanding warrants as of
June 30, 2007, having a weighted average exercise price of $1.62 per share (since June 30,
2007, 808,824 warrants were exercised at an exercise price of $1.23 per share); |
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5,912,095 shares of our common stock available for future grants or awards under our 2004
Equity Incentive Plan as of June 30, 2007; and |
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shares of common stock issuable upon the exercise of the warrants to be issued in
offering. |
RISK FACTORS
You should carefully consider the following risk factors before purchasing our common stock
and warrants. The risks and uncertainties described below are not the only ones we face. There may
be additional risks and uncertainties that are not known to us or that we do not consider to be
material at this time. If the events described in these risks occur, our business, financial
condition and results of operations would likely suffer. This prospectus supplement contains
forward-looking statements that involve risks and uncertainties. Our actual results may differ
significantly from the results discussed in the forward-looking statements. This section discusses
the risk factors that might cause those differences. You should also consider the additional
information set forth in our SEC reports on Forms 10-K, 10-Q and 8-K and in the other documents
considered a part of this prospectus supplement. See Where You Can Find More Information.
Risks Related To Our Business
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 June 30, 2007, we have incurred a cumulative net loss totaling approximately $159
million, and we have continued 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 incur significant operating losses 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.
We may not be able to raise the required capital to conduct our operations and develop our
products.
We will require substantial capital resources in order to conduct our operations and develop
our products and cell manufacturing facilities. We expect that our available cash, cash
equivalents, short-term investments and interest income available as of June 30, 2007 will be
sufficient to finance currently planned activities beyond the end of fiscal year 2008 (ending June
30, 2008). However, 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 additional funds. We will also need
S-4
additional funds or a collaborative partner, or both, to finance the research and development
activities of our cell product candidates for additional indications. Accordingly, we are
continuing to pursue additional sources of financing.
Our future capital requirements will depend upon many factors, including:
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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 |
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complementary business acquisition or development opportunities |
Because of our long-term funding requirements, we intend 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.
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 certain countries
in the EU. 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 technologies and product
candidates, or if one or more patients die or suffer severe complications, 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).
S-5
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 have delayed some
of our current planned clinical trials with TRC-based products in the EU, and 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.
Our inability to complete our product development activities successfully would severely limit our
ability to operate or finance operations.
Commercialization in the U.S. and the EU of our cell product candidates will require
completion of substantial clinical trials, and obtaining 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 are sufficient for a
marketable or regulatory approvable product.
S-6
Failure of third parties to manufacture component parts, provide limited source supplies or meet
our
specifications or quality standards, or 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 a third party manufacturer, Fraunhofer Institute for Interfacial Engineering and
Biotechnology in Stuttgart, Germany, to supply our TRC-based cell products for certain EU clinical
trials. 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. Both sites
could be subject to ongoing, periodic, unannounced inspection by regulatory agencies to ensure
strict compliance with cGMP 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 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 market place 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.
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
S-7
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.
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. 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.
If we do not keep pace with our competitors and with technological and market changes, our products
may become obsolete and our business will 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.
S-8
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.
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 two previous occasions. As a result
of these and other factors, we may not be successful in hiring or retaining key personnel. On July
17, 2006 we announced that George W. Dunbar had joined the Company as CEO, President and a
Director. Our inability to replace any key employee, including but not limited to Mr. Dunbar, could
harm our operations.
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.
S-9
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.
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.
Risks Related To Our Common Stock and Warrants
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 shares of
preferred stock and to fix the rights, preferences, privileges and restrictions of these shares
without any further vote or action by our shareholders. This authority, together with certain
provisions of our charter documents, may have the effect of making it more difficult for a third
party to acquire, or of discouraging a third party from attempting to acquire control of our
company. This effect could occur even if our shareholders consider the change in control to be in
their best interest.
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) to maintain the listing of our common stock on the Nasdaq Capital
Market. In May 2003 and in July 2004, we received notification from Nasdaq of potential delisting
as a result of our stock trading below $1.00 for more than thirty consecutive business days. While
in each case our stock price recovered within the permitted grace periods and Nasdaq notified us
that we were again in full compliance, we cannot provide any assurance that our stock price would
again recover within the specified
S-10
times if future closing bid prices below $1.00 triggered another potential delisting. The
qualitative tests we must meet address various corporate governance matters, including Audit
Committee and Board composition. In the past, we experienced director resignations and are devoting
increased resources to Board member recruitment and retention. If we do not maintain compliance
with the Nasdaq requirements within specified periods and subject to permitted extensions, our
common stock may be recommended for delisting (subject to any appeal we would file). 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 would
also impair our ability to raise capital.
The issuance of additional common stock or warrants for funding has the potential for substantial
dilution.
As noted above, we will need additional equity funding 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 and which may include the issuance of warrants. Such an equity issuance would
cause a substantially larger number of shares to be outstanding and would dilute the ownership
interest of existing shareholders.
Our stock price has been volatile and future sales of substantial numbers of our shares or warrants
could have an adverse effect on the market price of our shares.
The market price of shares of our common stock has been volatile, ranging in closing price
between $1.13 and $1.60 during the twelve month period ended June 30, 2007. 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 tissue engineering 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 |
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 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.
Risks Related To This Offering
We have broad discretion in the use of the net proceeds from this offering and may not use them
effectively.
S-11
Our management will have broad discretion in the application of the net proceeds from this
offering and could spend the proceeds in ways that do not necessarily improve our results of
operations or enhance the value of our common stock. The failure by our management to apply these
funds effectively could result in financial losses that could have a material adverse effect on our
business, financial condition, operating results and cash flow, and could cause the price of our
common stock to decline.
Substantial future sales of our common stock in the public market may depress our stock price.
As of August 31, 2007, we had approximately 121 million shares of common stock outstanding.
The market price of our common stock could drop due to sales of a large number of shares or the
perception that such sales could occur. These factors also could make it more difficult to raise
funds through future offerings of common stock or warrants.
The exercise of our outstanding options and warrants will dilute shareholders and could decrease
our stock price.
The existence of our outstanding options and warrants, including any warrants to be issued
pursuant to this offering, may adversely affect our stock price due to sales of a large number of
shares or the perception that such sales could occur. These factors also could make it more
difficult to raise funds through future offerings of common stock or warrants, and could adversely
impact the terms under which we could obtain additional equity capital. Exercise of outstanding
options and warrants, or any future issuance of additional shares of common stock or other equity
securities, including but not limited to options, warrants or other derivative securities
convertible into our common stock, may result in significant dilution to our shareholders and may
decrease our stock price.
FORWARD-LOOKING STATEMENTS
This prospectus supplement and the accompanying base prospectus, including the documents that
we incorporate by reference, contains forward-looking statements within the meaning of Section 27A
of the Securities Act and Section 21E of the Securities Exchange Act. Any statements about our
expectations, beliefs, plans, objectives, assumptions or future events or performance are not
historical facts and may be forward-looking. These statements are often, but are not always, made
through the use of words or phrases such as anticipates, estimates, plans, projects,
trends, opportunity, comfortable, current, intention, position, assume, potential,
outlook, remain, continue, maintain, sustain, seek, achieve, continuing, ongoing,
expects, management believes, we believe, we intend and similar words or phrases, or future
or conditional verbs such as will, would, should, could, may, or similar expressions.
Accordingly, these statements involve estimates, assumptions and uncertainties which could cause
actual results to differ materially from those expressed in them. Any forward-looking statements
are qualified in their entirety by reference to the factors discussed throughout this prospectus,
and in particular those factors listed under the section entitled 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.
S-12
USE OF PROCEEDS
We estimate that the net proceeds we will receive from this offering, assuming an offering
price of $ per share (the closing price of our common stock on the Nasdaq Capital Market on
October ___, 2007), will be approximately
$ million after deducting the placement agents fee
and estimated offering expenses and assuming that we sell the maximum number of shares offered
hereby. We will not receive any proceeds from the sale of common stock issuable upon exercise of
the warrants we are offering unless and until such warrants are exercised. If the warrants are
fully exercised for cash, we will receive additional proceeds of approximately $ million. We
will not pay the placement agent any fee with respect to shares of our common stock issued upon
exercise of the warrants.
We intend to use any net proceeds from this offering, together with other available funds, for
clinical trials and research and development, manufacturing development and expansion and working
capital and general corporate purposes, which may include the cost of a possible acquisition or the
development of complementary business activities.
We have not specifically identified the precise amounts we will spend on each of these areas
or the timing of these expenditures. The amounts actually expended for each purpose may vary
significantly depending upon numerous factors, including the amount and timing of the proceeds from
this offering, progress with clinical trials and other product development activities, other cell
therapy application programs and changing assessments of potential market opportunities and
competitive developments. In addition, expenditures may also depend on the establishment of new
collaborative arrangements with other companies, the availability of other financing, and other
factors.
We anticipate that we will be required to raise substantial additional capital to continue to
fund the clinical development of our cell therapy applications. We may raise additional capital
through additional public or private financing, as well as collaborative relationships, incurring
debt and other available sources.
DILUTION
If you invest in our common stock and warrants in this offering, your interest will be diluted
to the extent of the difference between the public offering price per share of our common stock and
the net tangible book value per share of our common stock immediately after this offering.
As of June 30, 2007, we had a net tangible book value of $28,251,000, or $0.24 per share of
common stock based upon 120,012,869 shares outstanding. Net tangible book value per share is equal
to our total tangible assets (total assets less intangible assets) less total liabilities, divided
by the number of shares of our outstanding common stock.
Dilution in net tangible book value per share represents the difference between the amount per
share paid by purchasers of shares of common stock and warrants in this offering and the net
tangible book value per share of common stock immediately after the completion of this offering.
Without taking into account any other changes in our net tangible book value since June 30, 2007,
after giving effect to our sale of units consisting of shares of common stock and warrants
to purchase shares of common stock in this offering at the public offering price of
$ per unit and after deducting the placement agents fee and estimated offering expenses
payable by us (but excluding any proceeds received upon exercise of warrants), our pro forma net
tangible book value as of June 30, 2007 would have been $ , or $ per share. This
amount represents an immediate increase in net tangible book value of $ per share to our
existing shareholders and an immediate dilution in net tangible book value of $ per share to
new investors purchasing our common stock and warrants in this offering. The following table
illustrates this per share dilution:
S-13
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Public offering price per share |
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$ |
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Net tangible book value per share as of June 30, 2007 |
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28,251,000 |
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Increase in net tangible book value per share
attributable to this offering |
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Pro forma net tangible book value per share as of
June 30, 2007 after giving effect to this offering |
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$ |
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Dilution per share to new investors in this offering |
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$ |
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These calculations exclude:
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a total of 10,837,936 shares of our common stock subject to outstanding
options under our current and previous equity incentive plans as of June 30, 2007,
having a weighted average exercise price of $1.47 per share (since June 30, 2007, an
additional 1,701,200 options have been issued at an average exercise price of $1.14
per share); |
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5,047,667 shares of our common stock issuable upon exercise of outstanding
warrants as of June 30, 2007, having a weighted average exercise price of $1.62 per
share (since June 30, 2007, 808,824 warrants were exercised at an exercise price of
$1.23 per share); |
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5,912,095 shares of our common stock available for future grants or awards
under our 2004 Equity Incentive Plan as of June 30, 2007; and |
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shares of common stock issuable upon the exercise of warrants to be
issued in this offering. |
To the extent that any of these options or warrants are exercised, there will be further
dilution to new investors. To the extent that additional capital is raised through the sale of
equity or convertible debt securities, the issuance of these securities could result in further
dilution to our shareholders.
DESCRIPTION OF WARRANTS
Each warrant represents the right to purchase up to ___shares of common stock at an exercise
price equal to $ per share, subject to adjustment as described below. Each warrant may be
exercised for cash on or after , 20___through and including , 20___.
The exercise price and the number of shares underlying the warrants are subject to appropriate
adjustment in the event of stock splits, stock dividends on our common stock, stock combinations or
similar events affecting our common stock. In addition, in the event we consummate any merger,
consolidation, sale or other reorganization event in which our common stock is converted into or
exchanged for securities, cash or other property, then following such event, the holders of the
warrants will be entitled to receive upon exercise of the warrants the kind and amount of
securities, cash or other property which the holders would have received had they exercised the
warrants immediately prior to such reorganization event.
No fractional shares of common stock will be issued in connection with the exercise of a
warrant. In lieu of fractional shares, we will pay the holder an amount in cash equal to the
fractional amount multiplied by the market value of a share of common stock.
A warrant may be transferred by a holder without our consent, upon surrender of the warrant to
us, properly endorsed (by the holder executing an assignment in the form attached to the warrant)
and upon payment of any necessary tax or other governmental charge imposed upon such transfer.
The warrants will not be listed on any securities exchange or automated quotation system and
we do not intend to arrange for any exchange or quotation system to list or quote the warrants.
S-14
The above summary of certain terms and provisions of the warrants is qualified in its entirety
by reference to the detailed provisions of the warrants, the form of which will be filed as an
exhibit to a Current Report on Form 8-K that will be incorporated by reference herein.
PLAN OF DISTRIBUTION
We are offering the shares of our common stock and warrants to purchase our common stock
through a placement agent. Subject to the terms and conditions contained in the placement agency
agreement dated October ___, 2007, BMO Capital Markets Corp. has agreed to act as the exclusive
placement agent for the sale of up to shares of our common stock and warrants to purchase
up to shares of our common stock. The placement agent is not purchasing or selling any
shares or warrants by this prospectus supplement or accompanying base prospectus, nor are they
required to arrange the purchase or sale of any specific number or dollar amount of units, but has
agreed to use commercially reasonable efforts to arrange for the sale of all shares and
warrants.
The placement agency agreement provides that the obligations of the placement agent and the
investors are subject to certain conditions precedent, including the absence of any material
adverse change in our business and the receipt of certain opinions, letters and certificates from
our counsel, our independent auditors and us.
Confirmations and definitive prospectuses will be delivered, or otherwise made available, to
all investors who agree to purchase shares of the common stock and warrants to purchase shares of
the common stock, informing investors of the closing date as to such shares and warrants. We
currently anticipate that closing of the sale of shares of common stock and warrants to
purchase shares of common stock will take place on or about October ___, 2007. Investors
will also be informed of the date and manner in which they must transmit the purchase price for
their shares.
On the scheduled closing date, the following will occur:
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we will receive funds in the amount of the aggregate purchase price; and |
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BMO Capital Markets Corp. will receive the placement agents fee in
accordance with the terms of the placement agency agreement. |
Pursuant to a requirement of the Financial Industry Regulatory Authority, or FINRA, the
maximum commission or discount to be received by any FINRA member or independent broker/dealer may
not be greater than eight percent (8.0%) of the gross proceeds received by us for the sale of any
securities being registered pursuant to SEC Rule 415.
We will pay the placement agent a fee equal to 6.0% of the gross proceeds of the sale of units
in the offering, without taking into account any proceeds from the
exercise of the warrants. The following table shows the per unit and total fees we will pay to the placement
agent assuming the sale of all of the units offered pursuant to this prospectus supplement.
Because there is no minimum offering amount required as a condition to closing, the actual
total may be less than the maximum amount set forth above.
The estimated offering expenses payable by us, in addition to the placement agents fee, are
approximately $150,000, which includes legal, accounting and printing costs and various other fees
associated with registering and listing the shares of common stock. After deducting certain fees
due to the placement agent and our estimated offering expenses, we expect the net proceeds from
this offering to be up to approximately $ .
S-15
We have agreed to indemnify the placement agent against certain liabilities, including
liabilities under the Securities Act of 1933, as amended. We have also agreed to contribute to
payments the placement agent may be required to make in respect of such liabilities.
Our executive officers and directors have agreed to a 90-day lock-up with respect to our
common stock, including securities convertible into or exercisable for our common stock. This means
that, subject to certain exceptions, for a period of 90 days following the date of this prospectus
supplement, these persons may not offer, sell, pledge or otherwise dispose of these securities
without the prior written consent of BMO Capital Markets Corp. We also have agreed to a 90-day
lock-up with respect to our common stock, including securities convertible into or exercisable
for our common stock. This means that, subject to certain exceptions, for a period of 90 days
following the date of this prospectus supplement, we may not offer, sell or otherwise dispose of
these securities without the prior written consent of BMO Capital Markets Corp.
This is a brief summary of the material provisions of the placement agency agreement and does
not purport to be a complete statement of its terms and conditions. A copy of the placement agency
agreement will be filed with the SEC and incorporated by reference into the registration statement
of which this prospectus supplement forms a part. See Where You Can Find More Information on page
S-16.
LEGAL MATTERS
The validity of the common stock and warrants offered hereby will be passed upon for Aastrom
by Dykema Gossett PLLC, Ann Arbor, Michigan acting as special counsel to Aastrom. Seyfarth Shaw
LLP, Chicago, Illinois, has acted as counsel to Aastrom in connection with this offering. Certain
legal matters will be passed upon for the placement agent by Morgan, Lewis & Bockius LLP, New York,
New York.
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, 2007, 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 file annual, quarterly and special reports, proxy statements and other information with the
SEC. You may read and copy any document we file at the SECs public reference rooms located at 100
F Street, N.E., Room 1580, Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for
further information on the public reference rooms. Our filings with the SEC are also available to
the public on the SECs Internet web site at http://www.sec.gov. We also provide information on our
website: http://www.aastrom.com/.
The SEC allows us to incorporate by reference the information we file with it, which means
that we can disclose important information to you by referring you to those documents. The
information incorporated by reference is considered to be part of this prospectus, and information
that we file with the SEC later will automatically update and supersede the information in this
prospectus or incorporated by reference. The following documents filed by us and any future filings
made by us with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of
1934, until we sell all of the common stock and warrants offered hereby, are incorporated by
reference in this prospectus:
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Our Annual Report on Form 10-K for the fiscal year ended June 30, 2007; |
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Our proxy statement for our annual shareholders meeting to be held on
November 7, 2007; |
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Our Current Reports on Form 8-K filed with the SEC on September 10, 2007,
September 11, 2007 and September 12, 2007; |
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The description of our common stock set forth in our Registration Statement
on Form 8-A filed with the SEC on April 11, 1997, as amended (Commission File No.:
000-22025); and |
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All of the filings pursuant to the Securities Exchange Act that we may make
after the date of this prospectus supplement and prior to the termination of this
offering. |
YOU MAY REQUEST A COPY OF THESE FILINGS, AT NO COST, BY WRITING OR TELEPHONING US AT AASTROM
BIOSCIENCES, INC., 24 FRANK LLOYD WRIGHT DRIVE, P.O. BOX 376, ANN ARBOR, MICHIGAN 48106, TELEPHONE
NUMBER: (734) 930-5555, ATTENTION: CHIEF FINANCIAL OFFICER.
The issuer has filed a registration statement (including a prospectus) with the SEC for the
offering to which this communication relates. Before you invest, you should read the prospectus in
that registration statement and other documents the issuer has filed with the SEC for more complete
information about the issuer and this offering. You may get these documents for free by visiting
EDGAR on the SEC Web site at www.sec.gov. Alternatively, the issuer, any underwriter or any dealer
participating in the offering will arrange to send you the prospectus if you request it by calling
toll-free at 1-800-414-3627.
S-17
SUBJECT TO COMPLETION, DATED OCTOBER 11, 2005
The information in this prospectus is not complete and may be changed. We may not sell these
securities under this prospectus until the registration statement filed with the Securities and
Exchange Commission is effective. This prospectus is not an offer to sell nor does it seek an offer
to buy these securities in any state where the offer and sale would not be permitted.
PROSPECTUS
$75,000,000
AASTROM BIOSCIENCES, INC.
Common Stock
Preferred Stock
Debt Securities
Warrants
We may from time to time issue, in one or more series or classes, up to $75,000,000 in
aggregate principal amount of our common stock, preferred stock, debt securities and/or warrants.
We may offer these securities separately or together. We will specify in the accompanying
prospectus supplement the terms of the securities being offered. We may sell these securities to or
through underwriters and also to other purchasers or through agents. We will set forth the names of
any underwriters or agents, and any fees, conversions, or discount arrangements, in the
accompanying prospectus supplement. We may not sell any securities under this prospectus without
delivery of the applicable prospectus supplement.
You should read this document and any prospectus supplement or amendment carefully before you
invest.
Our common stock is traded on the Nasdaq SmallCap Market under the symbol ASTM. On October
10, 2005, the last reported sale price for our common stock was $2.18 per share.
INVESTING IN OUR SECURITIES INVOLVES A HIGH DEGREE OF RISK. SEE RISK FACTORS BEGINNING ON
PAGE 5 FOR A DISCUSSION OF MATERIAL RISKS YOU SHOULD CONSIDER BEFORE YOU INVEST IN OUR SECURITIES.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED 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 October 11, 2005.
You should rely only on the information provided or incorporated by reference in this prospectus.
We have not authorized anyone to provide you with additional or different information. This
document may only be used where it is legal to sell these securities. You should not assume that
any information in this prospectus is accurate as of any date other than the date of this
prospectus.
TABLE OF CONTENTS
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PROSPECTUS SUMMARY |
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RISK FACTORS |
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RATIO OF EARNINGS TO FIXED CHARGES (1) |
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USE OF PROCEEDS |
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WHERE YOU CAN FIND MORE INFORMATION |
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THE SECURITIES WE MAY OFFER |
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DESCRIPTION OF CAPITAL STOCK |
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DESCRIPTION OF DEBT SECURITIES |
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DESCRIPTION OF WARRANTS |
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LEGAL OWNERSHIP OF SECURITIES |
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PLAN OF DISTRIBUTION |
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LEGAL MATTERS |
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EXPERTS |
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FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as
amended. Such forward-looking statements include statements regarding, among other things, (a) our
expectations about product development activities, (b) our growth strategies, (c) anticipated
trends in our industry, (d) our future financing plans, and (e) our anticipated needs for working
capital. Forward-looking statements, which involve assumptions and describe our future plans,
strategies, and expectations, are generally identifiable by use of the words may, will,
should, expect, anticipate, estimate, believe, intend, or project or the negative of
these words or other variations on these words or comparable terminology. This information may
involve known and unknown risks, uncertainties, and other factors that may cause our actual
results, performance, or achievements to be materially different from the future results,
performance, or achievements expressed or implied by any forward-looking statements. These
statements may be found under Managements Discussion and Analysis of Financial Condition and
Results of Operations and Business, in the Form 10-K and other reports that are incorporated by
reference into this prospectus as well as in this prospectus generally. Actual events or results
may differ materially from those discussed in forward-looking statements as a result of various
factors, including, without limitation, the risks outlined under Risk Factors and matters
described in this prospectus generally. In light of these risks and uncertainties, the events
anticipated in the forward-looking statements may not occur.
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PROSPECTUS SUMMARY
The following summary highlights selected information from this prospectus and in information
incorporated by reference. Because this is a summary, it does not contain all the information about
us that may be important to you. You should read this entire prospectus and the other documents and
the financial statements and related notes which are incorporated by reference in this prospectus.
Our Business
We are a development stage company focused on the development of the ex vivo production and
sale of proprietary human cell products for use in cell therapy and tissue regeneration. Our
pre-clinical and clinical product development programs utilize bone marrow-derived adult stem and
progenitor cell mixtures being investigated for aiding in the growth of tissues such as bone,
vascular tissue and cartilage, as well as blood and immune system cells.
In the expanding fields of cell therapy and tissue regeneration, we are developing proprietary
adult bone marrow cell-based products, some of which are now in the clinical stage, for the
regenerative repair of damaged human tissues and other medical disorders. Our lead products contain
TRCs, which are a unique mixture of bone marrow-derived adult stem and progenitor cells, produced
outside of the body or ex vivo from a small amount of bone marrow taken from the patient. In
clinical trials involving approximately 200 patients, our TRCs have been demonstrated to be safe
and reliable, and appeared to regenerate certain normal healthy human tissues.
We have also developed our proprietary AastromReplicell System®, which is a patented,
integrated system of instrumentation and single-use consumable kits for the commercial production
of human cells. The AastromReplicell System was developed to provide a manufacturing platform for
our proprietary cell products, such as our TRCs. The AastromReplicell System technology
has also been applied to the production of dendritic cells and dendritic cell vaccines for third
parties requiring automated cell production supporting GMP (Good Manufacturing Practice)
compliance. Since this third-party development activity is minimal at present, active development
and marketing activities targeting developers of dendritic cells and dendritic cell vaccines have
been halted.
Our commercial production pathway for our TRC cell products is in part enabled through the
AastromReplicell System platform. This proprietary and automated clinical cell production system
combines patented GMP-compliant automated cell production with patented single-pass perfusion.
Single-pass perfusion is our technology for growing large quantities of highly robust human cells
outside the body. These cells include adult stem and progenitor cell mixtures, which are the cells
believed to be required for forming tissues such as bone, vascular, cartilage, blood, and immune
system cells.
Our primary business model is to establish a core infrastructure for the manufacturing and
distribution of TRC cell products for use in multiple medical indications. Initially, we intend to
pursue TRC based cell products for the following therapeutic areas:
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Local bone regeneration such as is needed in fractures, spinal fusion, and
jaw bone reconstruction |
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Vascular (blood vessel) regeneration in limb ischemia resulting from diabetes
and other diseases |
In the future, we may develop and/or support the development by third parties of products for
other areas such as cartilage regeneration, cardiac tissue regeneration, and dendritic cell based
vaccines.
We do not have the sales or marketing organization that would be needed to commercialize our
therapeutic products. We intend to seek partnerships with other companies who have this capability,
as well
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as to develop our own ability to either support these relationships and, if necessary, to
complete some pilot level of sales and marketing activity ourselves.
In the EU, our business development activities are aided through our small, wholly-owned
subsidiaries located in Dublin, Ireland and Berlin, Germany.
Since our inception, we have been in the development stage and engaged in research and product
development, conducted principally on our own behalf, but also in connection with various
collaborative research and development agreements with others. Our initial business plan was to
pursue the bone marrow transplantation markets. At approximately the same time (late fiscal year
1999) that we intended to commence our initial pilot-scale product launch in the EU of the
AastromReplicell System with the SC-I kit, data was released at international meetings that
resulted in the majority of the patients who would otherwise have been candidates for the SC-I
product, to no longer require the use of the product. This loss of market for the SC-I caused us to
reorganize our operations and suspend all external activities in October 1999, pending the receipt
of additional financing and the completion of the reorganization process. We expanded the
capabilities of the AastromReplicell System to include dendritic cell production and initiated
pilot marketing activities for the CE Marked DC-I, DCV-I and the DCV-II products. However, only
minimal and irregular revenue has been generated from these products, and as a result it is no
longer a priority area for us. Therefore, we plan to limit our marketing efforts promoting the
AastromReplicell System as a stand-alone product. Rather our focus is on utilizing the
AastromReplicell System technology in cell manufacturing facilities to support our TRC development
programs. At such time as we satisfy applicable regulatory approval requirements, we expect the
sales of our TRC and our related cell-based products will 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 more significant TRC cell product sales commence. Until
that time, we expect that our revenue sources will consist of only minor sales from our dendritic
cell kits to academic and commercial research centers, grant revenue and research funding, and
potential licensing fees, or other financial support from potential future corporate collaborators.
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. This is not likely to occur until we obtain
significant additional funding and complete the required clinical trials for regulatory approvals,
and receive the necessary approvals to market our products. Through, June 30, 2005, we have
accumulated losses of approximately $125 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.
Our principal executive offices are located at 24 Frank Lloyd Wright Drive, P. O. Box 376, Ann
Arbor, MI 48106. Our telephone number is (734) 930-5555.
This Prospectus
This prospectus is part of a registration statement that we filed with the SEC utilizing a
shelf registration process. Under this shelf process, we may sell the securities described in
this prospectus in one or more offerings up to a total dollar amount of $75 million. We have
provided in this prospectus a general description of the securities we may offer. Each time we sell
securities, we will provide a prospectus supplement that will contain specific information about
the terms of that offering. We may also add, update or change in the prospectus supplement any of
the information contained in this prospectus. This prospectus, together with applicable prospectus
supplements, includes all material information relating to this offering. You should read both this
prospectus and any prospectus supplement together with the additional information described under
the heading Where You Can Find More Information.
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Risk Factors
You should consider carefully all of the information contained in and incorporated by
reference in this prospectus, including the information set forth under the caption Risk Factors,
before making an investment in the securities offered.
RISK FACTORS
You should carefully consider the following risk factors before purchasing our common stock.
The risks and uncertainties described below are not the only ones we face. There may be additional
risks and uncertainties that are not known to us or that we do not consider to be material at this
time. If the events described in these risks occur, our business, financial condition and results
of operations would likely suffer. This prospectus contains forward-looking statements that involve
risks and uncertainties. Our actual results may differ significantly from the results discussed in
the forward-looking statements. This section discusses the risk factors that might cause those
differences. You should also consider the additional information set forth in our SEC reports on
Forms 10-K, 10-Q and 8-K and in the other documents considered a part of this prospectus. See
Where You Can Find More Information.
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 June 30, 2005, we have incurred cumulative net losses totaling approximately $125
million. These losses have resulted principally from costs incurred in the research and development
of our cell culture technologies and the AastromReplicell System, general and administrative
expenses, and the prosecution of patent applications. We expect to incur significant operating
losses at least until, and probably after, product sales increase, primarily owing to our research
and development programs, including pre-clinical 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, obtaining regulatory approvals, establishing manufacturing, sales and marketing
arrangements with third parties, maintaining supplies of key manufacturing components, and raising
sufficient funds to finance our activities. We may not be able to achieve or sustain profitability.
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, and continue or increase sale of equipment, in those
jurisdictions, such as the EU. If we cannot demonstrate the safety, reliability and efficacy of our
cell product candidates, or of the cells produced in our device products, we may not be able to
obtain required regulatory approvals. If we cannot demonstrate the safety or efficacy of our
technologies and product candidates, including long-term sustained engraftment, or if one or more
patients die or suffer severe complications, 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.
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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. Although
the AastromReplicell System is currently considered to be unregulated manufacturing equipment in
the U.S., the FDA may reconsider this and classify the System as a Class III medical device, or may
ultimately choose to regulate the AastromReplicell System under another category. Because our
product development programs are designed to satisfy the standards applicable to medical devices
and 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. The AastromReplicell
System is used to produce different cell mixtures, and each of these cell mixtures (such as the
Tissue Repair Cells) may, under current regulations be regulated as a biologic product, which
requires a Biologic License Application (BLA).
The new EU Directives (laws) have become effective, and have influenced the requirements for
manufacturing cell products and the conduct of clinical trials. These changes have delayed or in
some cases temporarily halted clinical trials of cellular products in the EU. The recent changes to
the European Union Medicinal Products Prime Directive shifted patient-derived cells to the
medicinal products category, which will require license approvals in order to market and sell these
products. These new laws may delay some of our current planned clinical trials with Tissue Repair
Cells in the EU, and will require clinical trials with data submission and review by European
regulatory bodies. There is uncertainty as to the level of trials and data needed and because of
the recent nature of these regulations; there is no established precedent to understand the
timeline or other requirements for licensure.
Our inability to complete our product development activities successfully would severely limit our
ability to operate or finance operations.
Commercialization in the U.S. and the EU of our cell product candidates will require
completion of substantial clinical trials, and obtaining 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 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 in the EU, we must demonstrate,
through extensive preclinical studies and clinical trials, the safety and efficacy of our processes
and product candidates, for application in the treatment of humans. 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
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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 developing and evaluating new variations of TRCs that are
intended to improve the functionality for certain clinical indications, to improve shelf life, and
to decrease the cost of manufacturing our TRC products. These production process changes may alter
the functionality of our TRCs, and would require various levels of experimental and clinical
testing and evaluation. Any such testing or clinical study may affect regulatory review process and
lengthen the time before TRC 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 are sufficient for a
marketable or regulatory approvable product.
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 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 adopted at a level that would allow us to
operate profitably. Our TRCs will face competition from existing, and/or potential other new
treatments in the future which could limit revenue potential. It may be necessary to increase the
yield and/or cell type purity for certain of our AastromReplicell System cell processes to gain
commercial acceptance. 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.
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 available from third party
payors may reduce the demand for, or negatively affect the price of, our products. For example, in
the past, published studies have suggested that stem cell transplantation for breast cancer, that
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 would
negatively affect the marketability of our products.
Use of animal-derived materials could harm our product development and commercialization efforts.
Some of the compounds we use in, and are critical to, our TRC manufacturing processes involve
the use of animal-derived products, including fetal bovine serum. However, animal-derived cells are
not used as feeder cells in the growth of human TRCs. Suppliers or regulatory authorities may
limit or restrict the availability of such compounds for clinical and commercial use. For example,
the occurrence of so-called mad cow disease in the U.S. or in New Zealand may lead to a
restricted supply of the serum currently required for the TRC manufacturing process. Any
restrictions on these compounds would impose a potential competitive disadvantage for our products
or prevent our ability to manufacture TRC 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. It is unknown at this time what actions, if any, the authorities may
take as to animal derived materials specific to medicinal products
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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.
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 expect to
develop new configurations of the AastromReplicell System for these centralized facilities to
enable process and cost efficiencies associated with large-scale manufacturing. Establishing these
facilities will require significant capital and expertise. 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 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 our TRCs
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.
We may not be able to raise the required capital to conduct our operations and develop our
products.
We will require substantial capital resources in order to conduct our operations and develop
our products and cell manufacturing facilities. We expect that our available cash and interest
income, including that raised in the recent sale of common stock, described above, will be
sufficient to finance currently planned activities beyond the end of fiscal year 2006 (ending June
30, 2006). However, in order to grow and expand our business, and to introduce our new product
candidates into the marketplace, following sale of all of the securities offered hereby, we will
raise additional capital. We will also need additional funds or a collaborative partner, or both,
to finance the research and development activities of our product candidates for the expansion of
additional cell types. Accordingly, we are continuing to pursue additional sources of financing.
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; and |
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the effect of commercialization activities and facility expansions if and as required. |
Because of our long-term funding requirements, we intend 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.
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The issuance of additional common stock for funding has the potential for substantial dilution.
As noted above, we will need additional equity funding to provide us with the capital to reach
our objectives. At such time, 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 $0.63 and $4.05 during the twelve month period ended June 30, 2005. 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
announcements of research activities, business developments, technological innovations
or new products by us or our competitors 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 public concern regarding the
safety, efficacy or other aspects of the products or methodologies we are developing
news or reports from other stem cell, cell therapy or tissue engineering companies |
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reports by securities analysts |
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status of the investment markets |
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 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.
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) to maintain the listing of our common stock on the Nasdaq Stock
Market. In May 2003, and July 2004, we received notification from Nasdaq of potential delisting as
a result of our stock trading below $1.00 for more than thirty consecutive business days. While in
each case our stock price recovered within the permitted grace periods and Nasdaq notified us that
we were again in full compliance, we cannot provide any assurance that our stock price would again
recover within the specified times if future closing bid prices below $1.00 triggered another
potential delisting. The qualitative tests we must meet address various corporate governance
matters, including Audit Committee and Board composition. We have experienced recent director
resignations and are devoting increased resources to Board member recruitment and retention. If we
do not maintain compliance with the Nasdaq requirements within specified periods and subject to
permitted extensions, our common stock may be recommended for delisting (subject to any appeal we
would file). If our common stock were delisted, it could be more
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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 would also impair our ability to raise
capital.
Failure of third parties to manufacture component parts or provide limited source supplies, or
imposition of additional regulation, would impair our new product development and our sales
activities.
We rely solely on third parties such as Astro, Moll, Cambrex and Amgen to manufacture or
supply certain of our component parts, growth factors 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 fail to perform their
respective obligations or if our supply of growth factors, 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.
If we do not keep pace with our competitors and with technological and market changes, our products
may 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 products are 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. As a result, we may be unable to recover
the net book value of our inventories. Finally, to the extent that others develop new technologies
that address the targeted application for our products, our business will suffer.
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 two separate occasions. As a result
of these and other factors, we may not be successful in hiring or retaining key personnel. The
Company has a key man life insurance policy for R. Douglas Armstrong, Chief Executive Officer and
Chairman of Aastrom. Our inability to replace any lost key employee could harm our operations.
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
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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. 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, 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 use of the AastromReplicell System during research and development efforts, including clinical
trials, or after commercialization, results in adverse affects. 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.
Our corporate documents and Michigan law contain provisions that may make it more difficult for us
to be acquired.
Our Board of Directors has the authority, without shareholder approval, to issue additional
shares of preferred stock and to fix the rights, preferences, privileges and restrictions of these
shares without any further vote or action by our shareholders. This authority, together with
certain provisions of our charter documents, may have the affect 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 affect could occur even if our shareholders consider the change in control to be in
their best interest.
9
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, 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 effectiveness of our internal control over financial reporting
as of the end of the fiscal year, including a statement as to whether or not our internal control
over financial reporting is effective. 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 managements assessment of such internal controls. 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 are unable
to attest that our managements report is fairly stated or they are unable to express an opinion on
the effectiveness of our internal controls), we could lose investor confidence in the accuracy and
completeness of our financial reports, which would have a negative effect on our stock price and
our ability to raise capital.
Forward-looking statements
This registration statement contains certain forward-looking statements within the meaning of
Section 27A of the Securities Act and Section 21E of the Securities Exchange Act. 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 plans |
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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 |
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revenue expectations and operating results |
These statements are subject to risks and uncertainties, including those set forth in this
Risk Factors section and in the materials incorporated by reference into this prospectus, and
actual results could differ materially from those expressed or implied in these statements. In some
cases, you can identify these statements by our use of forward-looking words such as may, will,
should, anticipate, expect, estimate, plan, believe, potential, or intend. All
forward-looking statements included in this registration statement or in any prospectus supplement
are made as of the date hereof or thereof. We assume no obligation to update any such
forward-looking statement or to update any reason why actual results might differ.
RATIO OF EARNINGS TO FIXED CHARGES (1)
The following table sets forth ratios of earnings to fixed charges for the periods shown.
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Twelve Months Ended
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June 20
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June 30
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June 30
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June 30
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June 30 |
2005
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2004
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2003
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2002
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2001 |
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N/A (2)
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N/A (2)
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N/A (2)
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N/A (2)
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N/A (2) |
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(1) |
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The ratio of earnings to fixed charges was computed by dividing earnings by fixed charges.
For this purpose, earnings consist of net loss before fixed charges. Fixed charges consist of
interest expense plus the interest factor in lease expenses. During the fiscal years covered
by this table, we did not have any material fixed charges or preferred stock dividends.
However, our total lease expenses, which comprised most of our total commitments, were
$626,000, $616,000, $602,000, $547,000 and $495,000 for the twelve months ended June 30, 2005,
2004, 2003, 2002 and 2001. |
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Earnings have been inadequate to cover fixed charges and total commitments. The dollar amount
of the coverage deficiency was approximately $11.8 million, $10.5 million, $9.6 million,
$7.9 million and $5.9 million for the twelve months ended June 30, 2005, 2004, 2003, 2002 and
2001. |
USE OF PROCEEDS
We cannot guarantee that we will receive any proceeds in connection with this offering because
we may choose not to issue any securities covered by this prospectus.
Unless otherwise provided in a supplement or amendment to this prospectus, we intend to use
any net proceeds from this offering, together with other available funds, for operating costs,
capital expenditures and working capital needs and for other general corporate purposes.
We have not specifically identified the precise amounts we will spend on each of these areas
or the timing of these expenditures. The amounts actually expended for each purpose may vary
significantly depending upon numerous factors, including the amount and timing of the proceeds from
this offering, progress with clinical product development and other cell therapy application
programs. In addition, expenditures may also depend on the establishment of new collaborative
arrangements with other companies, the availability of other financing, and other factors.
We anticipate that we will be required to raise substantial additional capital to continue to
fund the clinical development of our cell therapy applications. We may raise additional capital
through additional public or private financing, as well as collaborative relationships, incurring
debt and other available sources.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other information with the
SEC. You may read and copy any document we file at the SECs public reference rooms located at 100
F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further
information on the public reference rooms. Our filings with the SEC are also available to the
public on the SECs Internet web site at http://www.sec.gov. We also provide information on our
website: http//www.aastrom.com/.
The SEC allows us to incorporate by reference the information we file with it, which means
that we can disclose important information to you by referring you to those documents. The
information incorporated by reference is considered to be part of this prospectus, and information
that we file with the SEC later will automatically update and supersede the information in this
prospectus or incorporated by reference. The following documents filed by us and any future filings
made by us with the SEC under Sections 13(a), 13(c) 14 or 15(d) of the Securities Exchange Act of
1934, until we sell all of the common stock offered hereby, are incorporated by reference in this
prospectus:
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Our Annual Report on Form 10-K for the fiscal year ended June 30, 2005; |
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Our Current Reports on Form 8-K, as amended, originally filed with SEC on
July 5, 2005; August 2, 2005 (and the amendment thereto filed on September 8, 2005);
August 25, 2005; September 8, 2005 (relating to the resignation of a director);
September 30, 2005; and October 11, 2005; and the amendment filed on September 8, 2005
to the 8-K originally filed on June 20, 2005; |
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The description of our common stock set forth in our Registration Statement
on Form 8-A filed with the SEC on April 11, 1997, as amended (Commission File No.:
000-22025). |
YOU MAY REQUEST A COPY OF THESE FILINGS, AT NO COST, BY WRITING OR TELEPHONING US AT AASTROM
BIOSCIENCES, INC., 24 FRANK LLOYD WRIGHT DRIVE, P.O. BOX 376, ANN ARBOR, MICHIGAN 48106, TELEPHONE
NUMBER (734) 930-5555, ATTENTION: CHIEF FINANCIAL OFFICER.
THE SECURITIES WE MAY OFFER
The descriptions of the securities contained in this prospectus, together with the applicable
prospectus supplements, summarize all the material terms and provisions of the various types of
securities that we may offer. We will describe in the applicable prospectus supplement the
particular terms of the securities offered by that prospectus supplement. If we indicate in the
applicable prospectus supplement, the terms of the securities may differ from the terms we have
summarized below. We will also include in the prospectus supplement information, where applicable,
about material United States federal income tax considerations relating to the securities, and the
securities exchange, if any, on which the securities will be listed.
DESCRIPTION OF CAPITAL STOCK
The following description of our capital stock and certain provisions of our articles of
incorporation and bylaws is a summary and is qualified in its entirety by the provisions of our
articles of incorporation and bylaws.
Our authorized capital stock consists of 200,000,000 shares of common stock, no par value per
share, and 5,000,000 shares of preferred stock, no par value per share.
Common Stock
Holders of our common stock are entitled to one vote for each share held of record on all
matters submitted to a vote of shareholders and do not have cumulative voting rights. Holders of
common stock have no preemptive, redemption or conversion rights and are not subject to future
calls or assessments. No sinking fund provisions apply to our common stock. All outstanding shares
are fully-paid and non-assessable. In the event of our liquidation, dissolution or winding up,
holders of common stock are entitled to share ratably in assets available for distribution, subject
to prior distribution rights of any preferred stock then outstanding. Holders of common stock are
entitled to receive proportionately any such dividends declared by the board of directors, out of
legally available funds for dividends, subject to any preferences that may be applicable to any
shares of preferred stock that may be outstanding at that time. The rights, preferences and
privileges of holders of common stock are set forth in our restated articles of incorporation,
which may be amended by the holders of at least two-thirds of the outstanding shares of common
stock.
Preferred Stock
Our Board of Directors is authorized to issue up to 5,000,000 shares of preferred stock in one
or more series without shareholder approval. Our Board of Directors may determine the rights,
preferences, privileges and restrictions, including voting rights, dividend rights, conversion
rights, redemption privileges and liquidation preferences of each series of preferred stock.
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The purpose of authorizing our Board of Directors to issue preferred stock in one or more
series and determine the number of shares in the series and its rights and preferences is to
eliminate delays associated with a shareholder vote on specific issuances. Examples of rights and
preferences that the Board of Directors may fix are: (1) dividend rights, (2) dividend rates, (3)
conversion rights, (4) voting rights, (5) terms of redemption, and (6) liquidation preferences. The
issuance of preferred stock, while providing desirable flexibility in connection with possible
acquisitions and other corporate purposes, could make it more difficult for a third party to
acquire, or could discourage a third party from acquiring, a majority of our outstanding voting
stock. The rights of holders of our common stock described above, will be subject to, and may be
adversely affected by, the rights of any preferred stock that we may designate and issue in the
future.
We will incorporate by reference as an exhibit to the registration statement which includes
this prospectus the form of any certificate of designation which describes the terms of the series
of preferred stock we are offering. This description and the applicable prospectus supplement will
include:
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the title and stated value; |
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the number of shares authorized; |
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the liquidation preference per share; |
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the purchase price; |
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the dividend rate, period and payment date, and method of calculation for dividends; |
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whether dividends will be cumulative or non-cumulative and, if cumulative,
the date from which dividends will accumulate; |
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the procedures for any auction and remarketing, if any; |
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the provisions for a sinking fund, if any; |
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the provisions for redemption or repurchase, if applicable, and any
restrictions on our ability to exercise those redemption and repurchase rights; |
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any listing of the preferred stock on any securities exchange or market; |
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whether the preferred stock will be convertible into our common stock, and,
if applicable, the conversion price, or how it will be calculated, and the conversion
period; |
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whether the preferred stock will be exchangeable into debt securities, and,
if applicable, the exchange price, or how it will be calculated, and the exchange
period; |
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voting rights, if any, of the preferred stock; |
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preemptive rights, if any; |
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restrictions on transfer, sale or other assignment, if any; |
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whether interests in the preferred stock will be represented by depositary shares; |
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a discussion of any material United States federal income tax considerations
applicable to the preferred stock; |
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the relative ranking and preferences of the preferred stock as to dividend
rights and rights if we liquidate, dissolve or wind up our affairs; |
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any limitations on issuance of any class or series of preferred stock ranking
senior to or on a parity with the series of preferred stock as to dividend rights and
rights if we liquidate, dissolve or wind up our affairs; and |
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any other specific terms, preferences, rights or limitations of, or
restrictions on, the preferred stock. |
When we issues share of preferred stock under this prospectus, the shares will fully be paid
and nonassessable and will not have, or be subject to, any preemptive or similar rights.
The Michigan Business Corporation Act provides that the holders of preferred stock will have
the right to vote separately as a class on any proposal involving an increase or decrease in the
authorized number of shares of that class, or changes in the powers, preferences or special rights
of holders of that preferred stock so as to affect the class adversely. This right is in addition
to any voting rights that may be provided for in the applicable certificate of designation.
Michigan Law and Certain Charter and By-Law Provisions
We are subject to certain anti-takeover provisions of the Michigan Business Corporation Act
(the MBCA) which could delay or make more difficult a merger or tender offer involving Aastrom.
Chapter 7A of the MBCA prevents, in general, an interested shareholder (defined generally as a
person owning 10% or more of a corporations outstanding voting shares) from engaging in a
business combination (as defined therein) with a Michigan corporation unless: (a) the Board of
Directors issues an advisory statement, holders of 90% of the shares of each class of stock
entitled to vote approve the transaction, and holders of two-thirds of the disinterested shares
of each class of stock approve the transaction; or (b) the interested shareholder has been an
interested shareholder for at least five years and has not acquired beneficial ownership of any
additional shares of the corporation subsequent to the transaction which resulted in such
shareholder being classified as an interested shareholder, and meets certain requirements,
including provisions relating to the fairness of the price and the form of consideration paid; or
(c) the Board of Directors, by resolution, exempts a particular interested shareholder from these
provisions prior to the interested shareholder becoming an interested shareholder. The MBCA also
contains certain other provisions which could have anti-takeover effects.
Our bylaws provide that the Board of Directors is divided into three classes of directors,
with each class serving a staggered three-year term. The classification system of electing
directors may tend to discourage a third party from making a tender offer or otherwise attempting
to obtain control of Aastrom and may maintain the incumbency of the Board of Directors, as it
generally makes it more difficult for shareholders to replace a majority of the directors. Our
restated articles of incorporation eliminate the right of shareholders to act without a meeting and
do not provide for cumulative voting in the election of directors. The amendment of any of these
provisions would require approval by holders of at least two-thirds of the shares of outstanding
common stock.
These and other provisions of our restated articles of incorporation could have the effect of
deterring certain takeovers or delaying or preventing certain changes in control or management of
Aastrom, including transactions in which shareholders might otherwise receive a premium for their
shares over then-current market prices.
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Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Continental Stock Transfer & Trust
Company.
DESCRIPTION OF DEBT SECURITIES
The following description, together with the additional information we include in any
applicable prospectus supplements, summarizes the material terms and provisions of the debt
securities that we may offer under this prospectus. While the terms we have summarized below will
apply generally to any future debt securities we may offer, we will describe the particular terms
of any debt securities that we may offer in more detail in the applicable prospectus supplement. If
we indicate in a prospectus supplement, the terms of any debt securities we offer under that
prospectus supplement may differ from the terms we describe below.
We will issue any senior notes under the senior indenture which we will enter into with a
trustee to be named in the senior indenture. We will issue any subordinated notes under the
subordinated indenture which we will enter into with a trustee to be named in the subordinated
indenture. We have filed forms of these documents as exhibits to the registration statement which
includes this prospectus. We use the term indentures to refer to both the senior indenture and
the subordinated indenture. The indentures will be qualified under the Trust Indenture Act. We use
the term debenture trustee to refer to either the senior trustee or the subordinated trustee, as
applicable.
The following summaries of material provisions of the senior notes, the subordinated notes and
the indentures are subject to, and qualified in their entirety by reference to, all the provisions
of the indenture applicable to a particular series of debt securities. Except as we may otherwise
indicate, the terms of the senior indenture and the subordinated indenture are identical.
We conduct some of our operations through a subsidiary formed under the laws of Germany. Our
rights and the rights of our creditors, including holders of debt securities, to the assets of any
subsidiary of ours upon that subsidiarys liquidation or reorganization or otherwise would be
subject to the prior claims of that subsidiarys creditors, except to the extent that we may be a
creditor with recognized claims against the subsidiary. Our subsidiarys creditors would include
trade creditors, debt holders, secured creditors and taxing authorities. Except as we may provide
in a prospectus supplement, neither the debt securities nor the indentures restrict us or our
subsidiary from incurring indebtedness.
General
We will describe in each prospectus supplement the following terms relating to a series of
notes:
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the title; |
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any limit on the amount that may be issued; |
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whether or not we will issue the series of notes in global form, the terms
and who the depository will be; |
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the maturity date; |
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the annual interest rate, which may be fixed or variable, or the method for
determining the rate; |
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the date interest will begin to accrue, the dates interest will be payable
and the regular record dates for interest payment dates or the method for determining
such dates; |
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whether or not the notes will be secured or unsecured, and the terms of any security; |
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the terms of the subordination of any series of subordinated debt; |
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the place where payments will be payable; |
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our right, if any, to defer payment of interest and the maximum length of any
such deferral period; |
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the date, if any, after which, and the price at which, we may, at our option,
redeem the series of notes pursuant to any optional redemption provisions; |
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the date, if any, on which, and the price at which we are obligated, pursuant
to any mandatory sinking fund provisions or otherwise, to redeem, or at the holders
option to purchase, all or a portion of the series of notes; |
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whether the indenture will restrict our ability to pay dividends, or will
require us to maintain any asset ratios or reserves; |
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whether we will be restricted from incurring any additional indebtedness; |
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a discussion of any material United States federal income tax considerations
applicable to the notes; |
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the denominations in which we will issue the series of notes, if other than
denominations of $1,000 and any integral multiple thereof; and |
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any other specific terms, preferences, rights or limitations of, or
restrictions on, the debt securities. |
Conversion or Exchange Rights
We will set forth in the prospectus supplement the terms on which a series of notes may be
convertible into or exchangeable for common stock or other securities of ours. We will include in
that prospectus supplement provisions as to whether conversion or exchange is mandatory, at the
option of the holder or at our option. We may include provisions pursuant to which the number of
shares of common stock or other securities of ours that the holders of the series of notes receive
would be subject to adjustment.
Consolidation, Merger or Sale
The indentures do not contain any covenant which restricts our ability to merge or
consolidate, or sell, convey, transfer or otherwise dispose of all or substantially all of our
assets. However, any successor to or acquirer of such assets must assume all of our obligations
under the indentures or the notes, as appropriate.
Events of Default Under the Indenture
The following are events of default under the indentures with respect to any series of notes
that we may issue:
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if we fail to pay interest when due and our failure continues for 60 days and
the time for payment has not been extended or deferred; |
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if we fail to pay the principal, or premium, if any, when due and the time
for payment has not been extended or delayed; |
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if we fail to observe or perform any other covenant contained in the notes or
the indentures, other than a covenant specifically relating to another series of
notes, and our failure continues for 60 days after we receive notice from the
debenture trustee or holders of at least 50% in aggregate principal amount of the
outstanding notes of the applicable series; and |
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if specified events of bankruptcy, insolvency or reorganization occur as to
us. |
If an event of default with respect to notes of any series occurs and is continuing, the
debenture trustee or the holders of at least 50% in aggregate principal amount of the outstanding
notes of that series, by notice to us in writing, and to the debenture trustee if notice is given
by such holders, may declare the unpaid principal of, premium, if any, and accrued interest, if
any, due and payable immediately.
The holders of a majority in principal amount of the outstanding notes of an affected series
may waive any default or event of default with respect to the series and its consequences, except
defaults or events of default regarding payment of principal, premium, if any, or interest, unless
we have cured the default or event of default in accordance with the indenture. Any waiver shall
cure the default or event of default.
Subject to the terms of the indentures, if an event of default under an indenture shall occur
and be continuing, the debenture trustee will be under no obligation to exercise any of its rights
or powers under such indenture at the request or direction of any of the holders of the applicable
series of notes, unless such holders have offered the debenture trustee reasonable indemnity. The
holders of a majority in principal amount of the outstanding notes of any series will have the
right to direct the time, method and place of conducting any proceeding for any remedy available to
the debenture trustee, or exercising any trust or power conferred on the debenture trustee, with
respect to the notes of that series, provided that:
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the direction so given by the holder is not in conflict with any law or the
applicable indenture; and |
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subject to its duties under the Trust Indenture Act, the debenture trustee
need not take any action that might involve it in personal liability or might be
unduly prejudicial to the holders not involved in the proceeding. |
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a holder of the notes of any series will only have the right to institute a
proceeding under the indentures or to appoint a receiver or trustee, or to seek other
remedies if: |
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the holder has given written notice to the debenture trustee of a continuing
event of default with respect to that series; |
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the holders of at least 50% in aggregate principal amount of the outstanding
notes of that series have made written request, and such holders have offered
reasonable indemnity to the debenture trustee to institute the proceeding as trustee;
and |
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the debenture trustee does not institute the proceeding, and does not receive
from the holders of a majority in aggregate principal amount of the outstanding notes
of that series other conflicting directions within 60 days after the notice, request
and offer. |
These limitations do not apply to a suit instituted by a holder of notes if we default in the
payment of the principal, premium, if any, or interest on, the notes.
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We will periodically file statements with the debenture trustee regarding our compliance with
specified covenants in the indentures.
Modification of Indenture; Waiver
We and the debenture trustee may change an indenture without the consent of any holders with
respect to specific matters, including:
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to fix any ambiguity, defect or inconsistency in the indenture; and |
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to change anything that does not materially adversely affect the interests of
any holder of notes of any series. |
In addition, under the indentures, the rights of holders of a series of notes may be changed
by us and the debenture trustee with the written consent of the holders of at least a majority in
aggregate principal amount of the outstanding notes of each series that is affected. However, we
and the debenture trustee may only make the following changes with the consent of each holder of
any outstanding notes affected:
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extending the fixed maturity of the series of notes; |
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reducing the principal amount, reducing the rate of or extending the time of
payment of interest, or any premium payable upon the redemption of any notes; or |
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reducing the percentage of notes, the holders of which are required to
consent to any amendment. |
Discharge
Each indenture provides that we can elect to be discharged from our obligations with respect
to one or more series of debt securities, except for obligations to:
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register the transfer or exchange of debt securities of the series; |
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replace stolen, lost or mutilated debt securities of the series; |
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maintain paying agencies; |
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hold monies for payment in trust; |
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compensate and indemnify the trustee; and |
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appoint any successor trustee. |
In order to exercise our rights to be discharged, we must deposit with the debenture trustee
money or government obligations sufficient to pay all the principal of, any premium, if any, and
interest on, the debt securities of the series on the dates payments are due.
Form, Exchange, and Transfer
We will issue the notes of each series only in fully registered form without coupons and,
unless we otherwise specify in the applicable prospectus supplement, in denominations of $1,000 and
any integral multiple thereof. The indentures provide that we may issue notes of a series in
temporary or permanent global form and as book-entry securities that will be deposited with, or on
behalf of, The Depository Trust
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Company or another depository named by us and identified in a prospectus supplement with
respect to that series. See Legal Ownership of Securities for a further description of the terms
relating to any book-entry securities.
At the option of the holder, subject to the terms of the indentures and the limitations
applicable to global securities described in the applicable prospectus supplement, the holder of
the notes of any series can exchange the notes for other notes of the same series, in any
authorized denomination and of like tenor and aggregate principal amount.
Subject to the terms of the indentures and the limitations applicable to global securities set
forth in the applicable prospectus supplement, holders of the notes may present the notes for
exchange or for registration of transfer, duly endorsed or with the form of transfer endorsed
thereon duly executed if so required by us or the security registrar, at the office of the security
registrar or at the office of any transfer agent designated by us for this purpose. Unless
otherwise provided in the notes that the holder presents for transfer or exchange, we will make no
service charge for any registration of transfer or exchange, but we may require payment of any
taxes or other governmental charges.
We will name in the applicable prospectus supplement the security registrar, and any transfer
agent in addition to the security registrar, that we initially designate for any notes. We may at
any time designate additional transfer agents or rescind the designation of any transfer agent or
approve a change in the office through which any transfer agent acts, except that we will be
required to maintain a transfer agent in each place of payment for the notes of each series.
If we elect to redeem the notes of any series, we will not be required to:
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issue, register the transfer of, or exchange any notes of that series during
a period beginning at the opening of business 15 days before the day of mailing of a
notice of redemption of any notes that may be selected for redemption and ending at
the close of business on the day of the mailing; or |
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register the transfer of or exchange any notes so selected for redemption, in
whole or in part, except the unredeemed portion of any notes we are redeeming in part. |
Information Concerning the Debenture Trustee
The debenture trustee, other than during the occurrence and continuance of an event of default
under an indenture, undertakes to perform only those duties as are specifically set forth in the
applicable indenture. Upon an event of default under an indenture, the debenture trustee must use
the same degree of care as a prudent person would exercise or use in the conduct of his or her own
affairs. Subject to this provision, the debenture trustee is under no obligation to exercise any of
the powers given it by the indentures at the request of any holder of notes unless it is offered
reasonable security and indemnity against the costs, expenses and liabilities that it might incur.
Payment and Paying Agents
Unless we otherwise indicate in the applicable prospectus supplement, we will make payment of
the interest on any notes on any interest payment date to the person in whose name the notes, or
one or more predecessor securities, are registered at the close of business on the regular record
date for the interest.
We will pay principal of and any premium and interest on the notes of a particular series at
the office of the paying agents designated by us, except that unless we otherwise indicate in the
applicable prospectus supplement, will we make interest payments by check which we will mail to the
holder. Unless we otherwise indicate in a prospectus supplement, we will designate the corporate
trust office of the debenture trustee in the City of New York as our sole paying agent for payments
with respect to notes of
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each series. We will name in the applicable prospectus supplement any other paying agents that
we initially designate for the notes of a particular series. We will maintain a paying agent in
each place of payment for the notes of a particular series.
All money we pay to a paying agent or the debenture trustee for the payment of the principal
of or any premium or interest on any notes which remains unclaimed at the end of two years after
such principal, premium or interest has become due and payable will be repaid to us, and the holder
of the security thereafter may look only to us for payment of those amounts.
Governing Law
The indentures and the notes will be governed by and construed in accordance with the laws of
the State of New York, except to the extent that the Trust Indenture Act is applicable.
Subordination of Subordinated Notes
The subordinated notes will be unsecured and will be subordinate and junior in priority of
payment to some or all of our other indebtedness to the extent described in a prospectus
supplement. The subordinated indenture does not limit the amount of subordinated notes which we may
issue. It also does not limit us from issuing any other secured or unsecured debt.
DESCRIPTION OF WARRANTS
The following description, together with the additional information we may include in any
applicable prospectus supplements, summarizes the material terms and provisions of the warrants
that we may offer under this prospectus and the related warrant agreements and warrant
certificates. While the terms summarized below will apply generally to any warrants that we may
offer, we will describe the particular terms of any series of warrants in more detail in the
applicable prospectus supplement. If we indicate in the prospectus supplement, the terms of any
warrants offered under that prospectus supplement may differ from the terms described below.
Specific warrant agreements will contain additional important terms and provisions and will be
incorporated by reference as an exhibit to the registration statement which includes this
prospectus.
General
We may issue warrants for the purchase of common stock, preferred stock and/or debt securities
in one or more series. We may issue warrants independently or together with common stock, preferred
stock and/or debt securities, and the warrants may be attached to or separate from these
securities.
We will evidence each series of warrants by warrant certificates that we will issue under a
separate warrant agreement. We will enter into the warrant agreement with a warrant agent. Each
warrant agent will be a bank that we select which has its principal office in the United States and
a combined capital and surplus of at least $50,000,000. We will indicate the name and address of
the warrant agent in the applicable prospectus supplement relating to a particular series of
warrants.
We will describe in the applicable prospectus supplement the terms of the series of warrants,
including:
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the offering price and aggregate number of warrants offered; |
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the currency for which the warrants may be purchased; |
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if applicable, the designation and terms of the securities with which the
warrants are issued and the number of warrants issued with each such security or each
principal amount of such security; |
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if applicable, the date on and after which the warrants and the related
securities will be separately transferable; |
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in the case of warrants to purchase debt securities, the principal amount of
debt securities purchasable upon exercise of one warrant and the price at, and
currency in which, this principal amount of debt securities may be purchased upon such
exercise; |
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in the case of warrants to purchase common stock or preferred stock, the
number of shares of common stock or preferred stock, as the case may be, purchasable
upon the exercise of one warrant and the price at which these shares may be purchased
upon such exercise; |
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the effect of any merger, consolidation, sale or other disposition of our
business on the warrant agreement and the warrants; |
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the terms of any rights to redeem or call the warrants; |
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any provisions for changes to or adjustments in the exercise price or number
of securities issuable upon exercise of the warrants; |
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the dates on which the right to exercise the warrants will commence and expire; |
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the manner in which the warrant agreement and warrants may be modified; |
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federal income tax consequences of holding or exercising the warrants; |
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the terms of the securities issuable upon exercise of the warrants; and |
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any other specific terms, preferences, rights or limitations of or
restrictions on the warrants. |
Before exercising their warrants, holders of warrants will not have any of the rights of
holders of the securities purchasable upon such exercise, including:
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in the case of warrants to purchase debt securities, the right to receive
payments of principal of, or any premium or interest on, the debt securities
purchasable upon exercise or to enforce covenants in the applicable indenture; or |
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in the case of warrants to purchase common stock or preferred stock, the
right to receive any dividends or payments upon our liquidation, dissolution or
winding up or to exercise any voting rights. |
Exercise of Warrants
Each warrant will entitle the holder to purchase the securities that we specify in the
applicable prospectus supplement at the exercise price that we describe in the applicable
prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement, holders
of the warrants may exercise the warrants at any time up to 5:00 P.M. New York time on the
expiration date that we set forth in the applicable prospectus supplement. After the close of
business on the expiration date, unexercised warrants will become void.
Holders of the warrants may exercise the warrants by delivering the warrant certificate
representing the warrants to be exercised together with specified information, and paying the
required
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amount to the warrant agent in immediately available funds, as provided in the applicable
prospectus supplement. We will set forth on the reverse side of the warrant certificate and in the
applicable prospectus supplement the information that the holder of the warrant will be required to
deliver to the warrant agent upon exercise.
Upon receipt of the required payment and the warrant certificate properly completed and duly
executed at the corporate trust office of the warrant agent or any other office indicated in the
applicable prospectus supplement, we will issue and deliver the securities purchasable upon such
exercise. If fewer than all of the warrants represented by the warrant certificate are exercised,
then we will issue a new warrant certificate for the remaining amount of warrants. If we so
indicate in the applicable prospectus supplement, holders of the warrants may surrender securities
as all or part of the exercise price for warrants.
Enforceability of Rights By Holders of Warrants
Each warrant agent will act solely as our agent under the applicable warrant agreement and
will not assume any obligation or relationship of agency or trust with any holder of any warrant. A
single bank or trust company may act as warrant agent for more than one issue or series of
warrants. A warrant agent will have no duty or responsibility in case of any default by us under
the applicable warrant agreement or warrant, including any duty or responsibility to initiate any
proceedings at law or otherwise, or to make any demand upon us. Any holder of a warrant may,
without the consent of the related warrant agent or the holder of any other warrant, enforce by
appropriate legal action its right to exercise, and receive the securities purchasable upon
exercise of, its warrants.
LEGAL OWNERSHIP OF SECURITIES
We can issue securities in registered form or in the form of one or more global securities. We
describe global securities in greater detail below. We refer to those persons who have securities
registered in their own names on the books that we or any applicable trustee maintain for this
purpose as the holders of those securities. These persons are the legal holders of the
securities. We refer to those persons who, indirectly through others, own beneficial interests in
securities that are not registered in their own names, as indirect holders of those securities.
As we discuss below, indirect holders are not legal holders, and investors in securities issued in
book-entry form or in street name will be indirect holders.
Book-Entry Holders
We may issue securities in book-entry form only, as we will specify in the applicable
prospectus supplement. This means securities may be represented by one or more global securities
registered in the name of a financial institution that holds them as depositary on behalf of other
financial institutions that participate in the depositarys book-entry system. These participating
institutions, which are referred to as participants, in turn, hold beneficial interests in the
securities on behalf of themselves or their customers.
Only the person in whose name a security is registered is recognized as the holder of that
security. Securities issued in global form will be registered in the name of the depositary or its
participants. Consequently, for securities issued in global form, we will recognize only the
depositary as the holder of the securities, and we will make all payments on the securities to the
depositary. The depositary passes along the payments it receives to its participants, which in turn
pass the payments along to their customers who are the beneficial owners. The depositary and its
participants do so under agreements they have made with one another or with their customers; they
are not obligated to do so under the terms of the securities.
As a result, investors in a book-entry security will not own securities directly. Instead,
they will own beneficial interests in a global security, through a bank, broker or other financial
institution that participates in the depositarys book-entry system or holds an interest through a
participant. As long as the securities are issued in global form, investors will be indirect
holders, and not holders, of the securities.
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Street Name Holders
We may terminate a global security or issue securities in non-global form. In these cases,
investors may choose to hold their securities in their own names or in street name. Securities
held by an investor in street name would be registered in the name of a bank, broker or other
financial institution that the investor chooses, and the investor would hold only a beneficial
interest in those securities through an account he or she maintains at that institution.
For securities held in street name, we will recognize only the banks, brokers and other
financial institutions in whose names the securities are registered as the holders of those
securities, and we will make all payments on those securities to them. These institutions pass
along the payments they receive to their customers who are the beneficial owners, but only because
they agree to do so in their customer agreements or because they are legally required to do so.
Investors who hold securities in street name will be indirect holders, not holders, of those
securities.
Legal Holders
Our obligations, as well as the obligations of any applicable trustee and of any third parties
employed by us or a trustee, run only to the holders of the securities. We do not have obligations
to investors who hold beneficial interests in global securities, in street name or by any other
indirect means. This will be the case whether an investor chooses to be an indirect holder of a
security or has no choice because we are issuing the securities only in global form.
For example, once we make a payment or give a notice to the holder, we have no further
responsibility for the payment or notice even if that holder is required, under agreements with
depositary participants or customers or by law, to pass the payment or notice along to the indirect
holders but does not do so. Similarly, we may want to obtain the approval of the holders to amend
an indenture, such as to relieve us of the consequences of a default or of our obligation to comply
with a particular provision of the indenture or for other purposes. In such an event, we would seek
approval only from the holders, and not the indirect holders, of the securities. Whether and how
the holders contact the indirect holders is up to the holders.
Special Considerations for Indirect Holders
If you hold securities through a bank, broker or other financial institution, either in
book-entry form or in street name, you should check with your own institution to find out:
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how it handles securities payments and notices; |
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whether it imposes fees or charges; |
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how it would handle a request for the holders consent, if ever required; |
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whether and how you can instruct it to send you securities registered in your
own name so you can be a holder, if that is permitted in the future; |
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how it would exercise rights under the securities if there were a default or
other event triggering the need for holders to act to protect their interests; and |
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if the securities are in book-entry form, how the depositarys rules and
procedures will affect these matters. |
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Global Securities
A global security is a security held by a depositary which represents one or more individual
securities. Generally, all securities represented by the same global securities will have the same
terms.
Each security issued in book-entry form will be represented by a global security that we
deposit with and register in the name of a financial institution or its nominee that we select. The
financial institution that we select for this purpose is called the depositary. Unless we specify
otherwise in the applicable prospectus supplement, The Depository Trust Company, New York, New
York, known as DTC, will be the depositary for all securities issued in book-entry form.
A global security may not be transferred to or registered in the name of anyone other than the
depositary, its nominee or a successor depositary, unless special termination situations arise. We
describe those situations below under Special Situations When a Global Security Will Be
Terminated. As a result of these arrangements, the depositary, or its nominee, will be the sole
registered owner and holder of all securities represented by a global security, and investors will
be permitted to own only beneficial interests in a global security. Beneficial interests must be
held by means of an account with a broker, bank or other financial institution that in turn has an
account with the depositary or with another institution that does. Thus, an investor whose security
is represented by a global security will not be a holder of the security, but only an indirect
holder of a beneficial interest in the global security.
If the prospectus supplement for a particular security indicates that the security will be
issued in global form only, then the security will be represented by a global security at all times
unless and until the global security is terminated. If termination occurs, we may issue the
securities through another book-entry clearing system or decide that the securities may no longer
be held through any book-entry clearing system.
Special Considerations for Global Securities
As an indirect holder, an investors rights relating to a global security will be governed by
the account rules of the investors financial institution and of the depositary, as well as general
laws relating to securities transfers. We do not recognize an indirect holder as a holder of
securities and instead deal only with the depositary that holds the global security.
If securities are issued only in the form of a global security, an investor should be aware of
the following:
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An investor cannot cause the securities to be registered in his or her name,
and cannot obtain non-global certificates for his or her interest in the securities,
except in the special situations we describe below; |
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An investor will be an indirect holder and must look to his or her own bank
or broker for payments on the securities and protection of his or her legal rights
relating to the securities, as we describe under this section; |
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An investor may not be able to sell interests in the securities to some
insurance companies and to other institutions that are required by law to own their
securities in non-book-entry form; |
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An investor may not be able to pledge his or her interest in a global
security in circumstances where certificates representing the securities must be
delivered to the lender or other beneficiary of the pledge in order for the pledge to
be effective; |
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The depositarys policies, which may change from time to time, will govern
payments, transfers, exchanges and other matters relating to an investors interest in
a global security. We and any applicable trustee have no responsibility for any aspect
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depositarys actions or for its records of ownership interests in a global
security. We and the trustee also do not supervise the depositary in any way; |
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The depositary may, and we understand that DTC will, require that those who
purchase and sell interests in a global security within its book- entry system use
immediately available funds, and your broker or bank may require you to do so as well;
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Financial institutions that participate in the depositarys book-entry
system, and through which an investor holds its interest in a global security, may
also have their own policies affecting payments, notices and other matters relating to
the securities. There may be more than one financial intermediary in the chain of
ownership for an investor. We do not monitor and are not responsible for the actions
of any of those intermediaries. |
Special Situations When a Global Security will be Terminated
In a few special situations described below, the global security will terminate and interests
in it will be exchanged for physical certificates representing those interests. After that
exchange, the choice of whether to hold securities directly or in street name will be up to the
investor. Investors must consult their own banks or brokers to find out how to have their interests
in securities transferred to their own name, so that they will be direct holders. We have described
the rights of holders and street name investors above.
The global security will terminate when the following special situations occur:
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if the depositary notifies us that it is unwilling, unable or no longer
qualified to continue as depositary for that global security and we do not appoint
another institution to act as depositary within 90 days; |
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if we notify any applicable trustee that we wish to terminate that global
security; or |
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if an event of default has occurred with regard to securities represented by
that global security and has not been cured or waived. |
The prospectus supplement may also list additional situations for terminating a global
security that would apply only to the particular series of securities covered by the prospectus
supplement. When a global security terminates, the depositary, and not we or any applicable
trustee, is responsible for deciding the names of the institutions that will be the initial direct
holders.
PLAN OF DISTRIBUTION
The securities being offered may be sold in one or more transactions at fixed prices, at
prevailing market prices at the time of sale, at prices related to the prevailing market prices, at
varying prices determined at the time of sale, or at negotiated prices. These sales may be effected
at various times in one or more of the following transactions, or in other kinds of transactions:
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through underwriters for resale to the public or investors: |
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transactions on the Nasdaq Stock Market or on any national securities
exchange or U.S. inter-dealer system of a registered national securities association
on which our common stock may be listed or quoted at the time of sale; |
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in the over-the-counter market; |
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in private transactions and transactions otherwise than on these exchanges or
systems or in the over-the-counter market; |
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in connection with short sales of the shares; |
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by pledge to secure debt and other obligations; |
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through the writing of options, whether the options are listed on an options
exchange or otherwise; |
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in connection with the writing of non-traded and exchange-traded call
options, in hedge transactions and in settlement of other transactions in standardized
or over-the-counter options; |
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through a combination of any of the above transactions; or |
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any other method permitted by law. |
We may sell our securities directly to one or more purchasers, or to or through underwriters,
dealers or agents or through a combination of those methods. The related prospectus supplement will
set forth the terms of each offering, including:
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the name or names of any agents, dealers, underwriters or investors who
purchase the securities; |
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the purchase price of the securities being offered and the proceeds we will
receive from the sale; |
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the amount of any compensation, discounts commissions or fees to be received
by the underwriters, dealer or agents; |
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any over-allotment options under which underwriters may purchase additional
securities from us; |
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any discounts or concessions allowed or reallowed or paid to dealers; |
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any securities exchanges on which such securities may be listed. |
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the terms of any indemnification provisions, including indemnification from
liabilities under the federal securities laws; and |
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the nature of any transaction by an underwriter, dealer or agent during the
offering that is intended to stabilize or maintain the market price of the securities. |
In addition, any securities covered by this prospectus which qualify for sale pursuant to
Regulation S, may be sold pursuant to Regulation S rather than pursuant to this prospectus.
In connection with the sale of our common stock, underwriters may receive compensation from us
or from purchasers of our common stock in the form of discounts, concessions or commissions.
Underwriters, dealers and agents that participate in the distribution of our common stock may be
deemed to be underwriters. Discounts or commissions they receive and any profit on their resale of
our common stock may be considered underwriting discounts and commissions under the Securities Act
of 1933.
We may agree to indemnify underwriters, dealers and agents who participate in the distribution
of our common stock against various liabilities, including liabilities under the Securities Act of
1933. We may also agree to contribute to payments which the underwriters, dealers or agents may be
required to make in
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respect of these liabilities. We may authorize dealers or other persons who act as our agents
to solicit offers by various institutions to purchase our common stock from us under contracts
which provide for payment and delivery on a future date. We may enter into these contracts with
commercial and savings banks, insurance companies, pension funds, investment companies, educational
and charitable institutions and others. If we enter into these agreements concerning any series of
our common stock, we will indicate that in the prospectus supplement or amendment.
In connection with an offering of our common stock, underwriters may engage in transactions
that stabilize, maintain or otherwise affect the price of our common stock. Specifically,
underwriters may over-allot in connection with the offering, creating a syndicate short position in
our common stock for their own account. In addition, underwriters may bid for, and purchase, our
common stock in the open market to cover short positions or to stabilize the price of our common
stock. Finally, underwriters may reclaim selling concessions allowed for distributing our common
stock in the offering if the underwriters repurchase previously distributed common stock in
transactions to cover short positions, in stabilization transactions or otherwise. Any of these
activities may stabilize or maintain the market price of our common stock above independent market
levels. Underwriters are not required to engage in any of these activities and may end any of these
activities at any time. Agents and underwriters may engage in transactions with, or perform
services for, us and our affiliates in the ordinary course of business.
LEGAL MATTERS
The validity of the common stock offered hereby will be passed upon for Aastrom by Dykema
Gossett PLLC, Ann Arbor, Michigan acting as special counsel to Aastrom. DLA Piper Rudnick Gray Cary
US LLP, San Diego, California, has acted as counsel to Aastrom in connection with this offering.
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, 2005, 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.
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Shares
Warrants to Purchase Shares
PROSPECTUS SUPPLEMENT
BMO Capital Markets
October , 2007