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Filed pursuant to Rule 424(b)(2)
Registration Number 333-32914
DATED APRIL 3, 2000
PROSPECTUS
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3,396,226 SHARES OF COMMON STOCK
AASTROM BIOSCIENCES, INC.
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This prospectus relates to the offer and sale of 3,396,226 shares of common
stock being offered by RGC International Investors, LDC. These shares include
1,132,075 shares that are issuable upon exercise of warrants.
Our common stock is quoted on the Nasdaq National Market under the symbol
"ASTM." The selling stockholder will determine the price it may offer or sell
shares of our common stock independent of Aastrom. On March 17, 2000, the last
sale price of our common stock was $5.8125.
INVESTING IN THE COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. YOU SHOULD
CONSIDER CAREFULLY THE RISK FACTORS BEGINNING ON PAGE 4 OF THIS PROSPECTUS
BEFORE MAKING A DECISION TO PURCHASE OUR STOCK.
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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.
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THE DATE OF THIS PROSPECTUS IS APRIL 3, 2000.
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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.
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TABLE OF CONTENTS
Page
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Summary........................................ 3
Risk Factors................................... 4
Where You Can Find More Information............ 12
Selling Shareholder............................ 13
Plan of Distribution........................... 14
Use of Proceeds................................ 16
Legal Matters.................................. 16
Experts........................................ 16
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SUMMARY
Because this is a summary, it does not contain all the information about us
that may be important to you. You should read the more detailed information and
the financial statements and related notes which are incorporated by reference
in this Prospectus.
AASTROM
Aastrom develops proprietary process technologies and devices for a range
of cell therapy applications. The AastromReplicell(TM) Cell Product System is
our lead product under development, and consists of a clinical cell culture
system that operates single-use therapy kits tailored for patient therapy in the
emerging cell therapy market. We had begun European commercialization of the
AastromReplicell(TM) System for use in stem cell therapy and had started a
pivotal study in the U.S. However, in October 1999 we suspended marketing
efforts in Europe and our U.S. clinical development activities until we obtained
additional funding. With recently received funding, we intend to recommence our
U.S. clinical development program, and are evaluating the possibility of
resuming marketing efforts in Europe.
We believe that the AastromReplicell(TM) System method will be a
cost-effective, less invasive and less time consuming alternative, or
improvement to, currently available stem cell collection methods and may enhance
the clinical utility of umbilical cord blood transplants by expanding the number
of cells available for transplant. The AastromReplicell(TM) System is designed
as a platform product which implements our pioneering stem cell replication
technology. We believe that the AastromReplicell(TM) System can be modified to
produce a wide variety of other cell types for selected emerging therapies
currently in development.
Stem cell therapy is a form of cell therapy used to restore blood and
immune system function to cancer patients following chemotherapy or radiation
therapy. Current stem cell collection methods, including bone marrow harvest and
peripheral blood progenitor cell mobilization, can be costly, invasive and
time-consuming for both medical personnel and patients. We believe that the
AastromReplicell(TM) System will offer significant advantages over traditional
stem cell collection methods. The AastromReplicell(TM) System is intended to be
used to produce cells for stem cell therapy from a small starting volume of bone
marrow or umbilical cord blood cells. Further, in an evaluation of seven
tumor-contaminated bone marrow samples that were expanded with the
AastromReplicell(TM) System process, the presence of breast cancer cells in each
sample was either substantially reduced or was no longer detectable. We believe
that the combination of passive tumor cell depletion during culture with the
lower starting volume of cells used for the process may result in a procedure
that offers a tumor-free or tumor-reduced cell product for transplant. Although
we may not market the AastromReplicell(TM) System in the United States for stem
cell therapy unless and until we receive FDA and other necessary regulatory
approvals, we have already completed production-level versions of the
AastromReplicell(TM) System and have obtained permission to affix the CE Mark to
such versions.
Aastrom's principal executive offices are located at 24 Frank Lloyd Wright
Drive, P. O. Box 376, Ann Arbor, MI 48106. Aastrom's telephone number is (734)
930-5555.
THE OFFERING
Common stock offered by the selling shareholder............ 3,396,226 shares
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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 which involve risks and uncertainties. Aastrom's actual results may
differ significantly from the results discussed in the forward-looking
statements. This section discusses some of the factors that might cause those
differences.
WE CANNOT BE CERTAIN THAT WE WILL 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. In October 1999, Aastrom was forced to
reduce operations based on its declining level of capital resources and its
limited financing alternatives available at that time. Although we have started
to restore operating activities, the previous reduction in our operating
activities has negatively affected our ability to develop our products and has
delayed our product development programs. Based on current funding and
anticipated operating activities, we expect that our available cash and expected
interest income will only be sufficient to finance our current activities into
late 2000. This is a forward-looking statement and could be negatively affected
by funding limitations and other factors discussed under this heading. We are
currently pursuing additional sources of financing. If we can not obtain
additional funding prior to that time, Aastrom will be forced to make
substantial reductions in the scope and size of its operations, and may be
forced to curtail activities that we currently plan to resume. In order to grow
and expand our business, and to introduce our product candidates into the
marketplace, Aastrom will need to raise additional funds. We will also need
additional funds or a collaborative partner, or both, to finance the research
and development activities of Aastrom's product candidates for the expansion of
additional cell types.
Aastrom's future capital requirements will depend upon many factors,
including:
. continued scientific progress in its research and development
programs;
. costs and timing of conducting clinical trials and seeking regulatory
approvals and patent prosecutions;
. competing technological and market developments;
. the ability of Aastrom to establish additional collaborative
relationships; and
. effective commercialization activities and facility expansions if and
as required.
Because of our long-term funding requirements, we may attempt to access the
public or private equity markets if and whenever conditions are favorable, even
if we do not have an immediate need for additional capital at that time.
Further, we may enter into financing transactions at rates which are at a
substantial discount to market. Currently we have approximately five million
shares of common stock authorized and available for any financing transactions.
We intend to increase the number of shares of authorized common stock, and will
need stockholder approval to do so. Until such additional shares are duly
authorized, we may be limited in our ability to raise additional funding. This
additional funding may not be available to us on reasonable terms, or at all. If
adequate funds are not available, 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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IF WE CANNOT COMPLETE OUR PRODUCT DEVELOPMENT ACTIVITIES SUCCESSFULLY, OUR
ABILITY TO OPERATE OR FINANCE OPERATIONS WILL BE SEVERELY LIMITED.
Commercialization in the United States of our lead product candidate, the
AastromReplicell(TM) CeLL Production System, will require additional research
and development by Aastrom as well as substantial clinical trials. While we have
commenced initial marketing on a very limited basis of the Aastrom Replicell(TM)
System IN Europe, we believe that the United States will be the principal market
for our products. Aastrom may not be able to successfully complete development
of the AastromReplicell(TM) System or its other product candidates, or
successfully market its technologies or product candidates. Aastrom or its
potential collaborators may encounter problems and delays relating to research
and development, regulatory approval and intellectual property rights of
Aastrom's technologies and product candidates. Aastrom's research and
development programs may not be successful, and its cell culture technologies
and product candidates may not facilitate the ex vivo production of cells with
the expected biological activities in humans. Our technologies and product
candidates may not prove to be safe and efficacious in clinical trials, and we
may not obtain the intended 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 OUR
PRODUCTS.
To be able to market products in the United States, Aastrom must
demonstrate, through extensive preclinical studies and clinical trials, the
safety and efficacy of its processes and product candidates, together with the
cells produced by such processes in such products, for application in the
treatment of humans. Aastrom is currently conducting a pivotal clinical trial to
demonstrate the safety and biological activity of patient-derived cells produced
in the AastromReplicell(TM) System. Depending on the availability of resources,
we intend to commence two other pivotal clinical trials to demonstrate the
safety and biological activity of umbilical cord blood cells produced in the
AastromReplicell(TM) System. 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 stem 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.
FAILURE TO OBTAIN AND MAINTAIN REQUIRED REGULATORY APPROVALS WOULD SEVERELY
LIMIT OUR ABILITY TO SELL OUR PRODUCTS.
We must obtain the approval of the U.S. Food and Drug Administration
before commercial sales of our product candidates may commence in the United
States, which we believe will be the principal market for our products. We may
also be required to obtain additional approvals from foreign regulatory
authorities to continue or increase our sales activities in those jurisdictions.
If we cannot demonstrate the safety, reliability and efficacy of our product
candidates, or of the cells produced in such products, we may not be able to
obtain required regulatory approvals. Many of the patients enrolled in the
clinical trials will have previously undergone extensive treatment which will
have substantially weakened the patients and may have irreparably damaged the
ability of their blood and immune systems to recover. Some patients undergoing
the transplant recovery process have died, from causes that were, according to
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the physicians involved, unrelated to the AastromReplicell(TM) System procedure,
and it is possible that other patients may die or suffer severe complications
during the course of either the current trials or future trials. In addition,
patients receiving cells produced with Aastrom's technologies and product
candidates may not demonstrate long-term engraftment in a manner comparable to
cells obtained from current stem cell therapy procedures. 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, other regulatory
agencies, and governments in other countries continue to review and inspect
marketed products, manufacturers and manufacturing facilities. 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, governmental regulatory agencies may
establish additional regulations which could prevent or delay regulatory
approval of our products.
EVEN IF WE OBTAIN REGULATORY APPROVALS TO SELL OUR PRODUCTS, LACK OF COMMERCIAL
ACCEPTANCE WOULD IMPAIR OUR BUSINESS.
Aastrom's product development efforts are primarily directed toward
obtaining regulatory approval to market the AastromReplicell(TM) System as an
alternative to, or as an improvement for, the bone marrow harvest and peripheral
blood progenitor cell stem cell collection methods. These stem cell collection
methods have been widely practiced for a number of years, and Aastrom's
technologies or product candidates may not be accepted by the marketplace as
readily as these or other competing processes and methodologies. Additionally,
our technologies or product candidates may not be employed in all potential
applications being investigated, and any limited applications would limit the
market acceptance of our technologies and product candidates and our potential
revenues. As a result, 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.
FAILURE OF THIRD PARTIES TO MANUFACTURE COMPONENT PARTS OR PROVIDE LIMITED
SOURCE SUPPLIES WOULD IMPAIR OUR NEW PRODUCT DEVELOPMENT AND OUR SALES
ACTIVITIES.
Aastrom relies solely on third parties to manufacture its product
candidates and their component parts. Aastrom also relies solely on third party
suppliers to provide necessary key mechanical components, as well as growth
factors and other materials used in the cell expansion 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.
Furthermore, some of the compounds used by Aastrom in its current stem
cell expansion processes involve the use of animal-derived products. Suppliers
or regulatory authorities may limit or restrict the availability of such
compounds for clinical and commercial use. Any restrictions on these compounds
would impose a potential competitive disadvantage for Aastrom's products. If
Aastrom was not able to develop or obtain alternative compounds, its product
development and commercialization efforts would be harmed.
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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.
OUR PAST LOSSES AND EXPECTED FUTURE LOSSES CAST DOUBT ON OUR ABILITY TO OPERATE
PROFITABLY.
Aastrom was incorporated in 1989 and has experienced substantial
operating losses since inception. As of December 31, 1999, Aastrom has incurred
net operating losses totaling approximately $75.2 million. These losses have
resulted principally from costs incurred in the research and development of
Aastrom's cell culture technologies and the AastromReplicell(TM) System, general
and administrative expenses, and the prosecution of patent applications. Aastrom
expects to incur significant operating losses until product sales increase,
primarily owing to its research and development programs, including preclinical
studies and clinical trials, and the establishment of marketing and distribution
capabilities necessary to support commercialization efforts for its products.
Aastrom cannot predict with any certainty the amount of future losses. Aastrom's
ability to achieve profitability will depend, among other things, on
successfully completing the development of its product candidates, obtaining
regulatory approvals, establishing manufacturing, sales and marketing
arrangements with third parties, and raising sufficient funds to finance its
activities. Aastrom may not be able to achieve or sustain profitability.
GIVEN OUR LIMITED INTERNAL SALES AND MARKETING CAPABILITIES, WE NEED TO DEVELOP
COLLABORATIVE RELATIONSHIPS TO SELL, MARKET AND DISTRIBUTE OUR PRODUCTS.
While we have commenced initial marketing on a limited basis of the
AastromReplicell(TM) System in Europe, we have only limited internal sales,
marketing and distribution capabilities. We intend to market our products
through collaborative relationships with companies for sales, marketing and
distribution capabilities. If we cannot develop and maintain those
relationships, we would have only limited abilities to market, sell and
distribute our products. Even if we are able to enter into those relationships,
they may not succeed or be sustained on a long-term basis, and termination would
require us to develop alternate arrangements at a time when we need sales,
marketing or distribution capabilities to meet existing demand. For example, in
November 1998 Aastrom and COBE BCT terminated their strategic alliance for the
worldwide distribution of the AastromReplicell(TM) System for stem cell therapy
and related uses and Aastrom is seeking to enter into other arrangements
relating to the development and marketing of our product candidates.
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 FDA has indicated it intends to regulate the
AastromReplicell(TM) System for stem cell therapy as a Class III medical device,
the FDA may ultimately choose to regulate the AastromReplicell(TM) System under
another category. Because our product development programs are designed to
satisfy the standards applicable to Class III medical devices, a change in the
regulatory classification would affect our ability to obtain FDA approval of our
products. Also, the FDA is in the process of developing its requirements with
respect to somatic cell therapy and gene cell therapy products. Until the FDA
issues definitive regulations covering our product candidates, the regulatory
guidelines or requirements for approval of such product candidates will continue
to be uncertain.
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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 market for our product is very competitive and is subject to rapid
technological changes. Many of Aastrom's competitors have significantly greater
resources, more product candidates and have developed product candidates and
processes that directly compete with Aastrom's products. Aastrom's competitors
may have developed, or could in the future develop, new technologies that
compete with our products or even render our products obsolete. In addition,
some recently published studies have suggested that stem cell therapy, which is
the current principal market for our products, may have limited clinical benefit
in the treatment of breast cancer, which is a significant portion of the current
overall stem cell transplant market. Our products are designed to improve upon
traditional stem cell collection methods, but even if we are able to demonstrate
improved or equivalent results, practitioners may not switch to our new
processes. Given the experience and expertise associated with traditional
methods, if we cannot develop our cell production procedure to lead to a less
expensive and quicker recovery time than seen with the traditional methods, we
will suffer a competitive disadvantage. Finally, to the extent that others
develop new technologies that address the diseases and health conditions we have
targeted, our business will suffer.
IF OUR PATENTS AND PROPRIETARY RIGHTS DO NOT PROVIDE SUBSTANTIAL PROTECTION, 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, we cannot be assured
that patents will be granted on any of our pending or future patent
applications. We also cannot be assured that the scope of any of our issued
patents will 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. Furthermore, Aastrom relies on licenses granted
by the University of Michigan for certain of its patent rights. If Aastrom
breaches such agreements or otherwise fails to comply with such agreements, or
if such agreements expire or are otherwise terminated, Aastrom may lose its
rights under the patents held by the University of Michigan. Aastrom also relies
on trade secrets and unpatentable know-how which it seeks to protect, in part,
by confidentiality agreements with its employees, consultants, suppliers and
licensees. These agreements may be breached, and Aastrom 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.
Aastrom's success will also depend in part on its ability to develop
commercially viable products without infringing the proprietary rights of
others. Although Aastrom has 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, Aastrom may be forced to litigate.
Intellectual property litigation would divert management's attention from
developing our products and would force Aastrom to incur substantial costs
regardless of whether we are successful. An adverse outcome could subject
Aastrom to significant liabilities to third parties, and force Aastrom to
curtail or cease its development and sale of its products and processes.
THE MARKET FOR OUR PRODUCTS WILL BE HEAVILY DEPENDENT ON THIRD PARTY
REIMBURSEMENT POLICIES.
Aastrom's ability to successfully commercialize its product candidates
will depend on the extent to which government healthcare programs, such as
Medicare and Medicaid, as well as private health
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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 payor's 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 United States or foreign countries may not be available or
maintained for any of Aastrom's 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.
POTENTIAL PRODUCT LIABILITY CLAIMS COULD EFFECT OUR EARNINGS AND FINANCIAL
CONDITION.
Aastrom faces an inherent business risk of exposure to product liability
claims in the event that the use of the AastromReplicell(TM) System during
research and development efforts, including clinical trials, or after
commercialization results in adverse effects. As a result, Aastrom 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.
IF WE CANNOT ATTRACT AND RETAIN KEY PERSONNEL, 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. For example, since our initial public offering in February 1997
three of the six executive officers who were with Aastrom at the time have since
left for positions with other organizations and Aastrom has hired two new
executive officers to assume their responsibilities, one of which subsequently
left. Further, in an effort to conserve financial resources, we have been forced
to implement 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 WARRANTS HAVE THE POTENTIAL FOR SUBSTANTIAL DILUTION.
The exercise price of the warrants that we issued in February 2000 is
subject to certain reset provisions in the event the price of our common stock
goes down at specified times in the future or if we issue additional securities
at less than the warrant exercise price. If such an adjustment were made to the
exercise price of the warrants, there would also be an increase in the number of
shares that could be issued upon exercise of the warrants. The warrants are
currently exercisable for 1,132,075 shares of common stock. This number of
shares could increase to 2,614,386 shares of common stock and the exercise price
could be reduced to as low as $1.60 per share. Purchasers of common stock could
therefore experience dilution of their investment upon exercise of the warrants.
The warrants are not registered and may be sold only if registered under the
Securities Act or sold in accordance with an applicable exemption from
registration, such as Rule 144.
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OUR STOCK PRICE HAS BEEN VOLATILE AND FUTURE SALES OF SUBSTANTIAL NUMBERS OF OUR
SHARES COULD HAVE AN ADVERSE EFFECT ON THE MARKET PRICE OF OUR SHARES.
The market price of shares of our common stock has been volatile. The price
of our common stock may continue to fluctuate in response to a number of events
and factors, such as:
. clinical trial results;
. the amount of our cash resources and our ability to obtain additional
funding;
. announcements of research activities, business developments,
technological innovations or new products
. by us or our competitors;
. changes in government regulation;
. disputes concerning patents or proprietary rights;
. changes in our revenues or expense levels;
. public concern regarding the safety, efficacy or other aspects of the
products or methodologies we are developing; and
. changes in potential recommendations by securities analysts.
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 experience 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 shares, regardless of our operating performance or prospects. For example,
within the last year, our stock price has experienced a day where it traded at
approximately twice the previous day's closing price and another day when it
dropped by over 20% from the previous day's closing price.
In addition, sales, or the possibility of sales, of substantial numbers
of shares of common stock in the public market could adversely affect prevailing
market prices of shares of common stock. Our employees hold a significant number
of options to purchase shares, many of which are presently exercisable.
Employees may exercise their options and sell shares shortly after such options
become exercisable, particularly if they need to raise funds to pay for the
exercise of such options or to satisfy tax liabilities that they may incur in
connection with exercising their options. Additionally, beginning January 1,
2001, COBE BCT will be able to sell all of its approximately 2.4 million shares
of our common stock without restriction.
OUR CORPORATE DOCUMENTS AND MICHIGAN LAW CONTAIN PROVISIONS THAT MAY MAKE IT
MORE DIFFICULT FOR US TO BE ACQUIRED.
Our board of directors has the authority, without shareholder approval, to
issue additional shares of preferred stock and to fix the rights, preferences,
privileges and restrictions of these shares without any further vote or action
by our shareholders. This authority, together with certain provisions of our
charter documents, may have the effect of making it more difficult for a third
party to acquire, or of discouraging a third party from attempting to acquire,
control of our company. This effect could occur even if our shareholders
consider the change in control to be in their best interest.
WE MAY BE REQUIRED TO REDEEM A PORTION OF OUR SHARES, WHICH WOULD SIGNIFICANTLY
REDUCE OUR LIMITED CASH RESOURCES.
The original purchasers of the Shares and warrants may require us to redeem
some or all of those Shares in the event that the Company fails to perform
certain administrative activities that are within its control. These
administrative activities includes: issuing the shares of common stock upon the
exercise of the warrants, transferring or instructing the transfer agent to
transfer shares of common stock issued upon exercise of the warrants when
required and removing any restrictive legends from such shares of common stock
when required. This redemption could significantly reduce our limited capital
resources.
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OUR STOCK MAY BE DELISTED FROM NASDAQ, WHICH COULD AFFECT ITS MARKET PRICE AND
LIQUIDITY.
We are required to meet certain financial tests (including, but not limited
to, a minimum bid price of our common stock of $1.00 and $4 million in tangible
net worth) to maintain the listing of our common stock on the Nasdaq National
Market. Within the last six months, our common stock price has fallen below the
minimum level for some periods and during other periods our tangible net worth
has been below the amount required. In the future, our stock price or tangible
net worth may fall below the Nasdaq requirements, or we may not comply with
other listing requirements, and our common stock might be delisted. If that
happened the market price and liquidity of our common stock would be impaired
ABSENCE OF DIVIDENDS COULD REDUCE OUR ATTRACTIVENESS TO INVESTORS.
Some investors favor companies that pay dividends, particularly in market
downturns. Aastrom has never paid cash dividends on its common stock and does
not anticipate paying any cash dividends on its common stock in the foreseeable
future. Therefore, your return on this investment will depend on your ability to
sell our stock at a profit.
FORWARD-LOOKING STATEMENTS
This prospectus 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:
. uncertainties related to potential strategic collaborations with
others;
. future capital needs and uncertainty of additional funding;
. uncertainties related to product development and marketability;
. uncertainties related to clinical trials;
. manufacturing and supply uncertainties and dependence on third
parties;
. anticipation of future losses;
. limited sales and marketing capabilities;
. uncertainty of regulatory approval and extensive government
regulation;
. competition and technological change;
. uncertainty regarding patents and proprietary rights;
. no assurance of third party reimbursement;
. hazardous materials; and
. potential product liability and availability of insurance.
These statements are subject to risks and uncertainties, including those set
forth in this Risk Factors section, and actual results could differ materially
from those expressed or implied in these statements. All forward-looking
statements included in this prospectus are made as of the date hereof. Aastrom
assumes no obligation to update any such forward-looking statement or reason why
actual results might differ.
RECENT DEVELOPMENTS
As of December 31, 1999 there were 4,000 shares of 1998 Series I
Convertible Preferred Stock and 1,550 shares of 1999 Series III Preferred Stock
outstanding. During January and February 2000, all of those shares of preferred
stock were converted into 7,954,647 shares of common stock. On February 29,
2000, the Company completed the sale of 2,264,151 units, each of which consists
of one share of common stock and a three-year warrant to purchase one-half of
one share of common stock at an initial exercise price of $3.69 per share. On
March 7, 2000, Robert J. Kunze resigned from the Company's Board of Directors.
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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
SEC's public reference rooms located at Room 1024, 450 Fifth Street, N.W.,
Washington, D.C. 20549, at The Citicorp Center, 500 West Madison Street, Suite
1400, Chicago, Illinois 60661, and at Seven World Trade Center, Suite 1300, New
York, New York 10048. 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 SEC's Internet web site at http://www.sec.gov.
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 the selling shareholder
sells all of the common stock offered hereby, are incorporated by reference in
this Prospectus:
(a) the Company's Annual Report on Form 10-K for the year ended June 30,
1999 (Commission File No.: 000-22025), but specifically excluding The
Report of the Independent Accountants thereto which is superceded by
the report included in the Company's current report on Form 8-K filed
on December 10, 1999 (Commission File No. 000-22025);
(b) the Company's Quarterly Report on Form 10-Q for the quarter ended
September 30, 1999 (Commission File No. 000-22025);
(c) the Company's Quarterly Report on Form 10-Q for the quarter ended
December 31, 1999 (Commission File No. 000-22025);
(d) the Company's Current Report of Form 8-K filed with the Commission on
October 27, 1999 (Commission File No.: 000-22025);
(e) the Company's Current Report of Form 8-K filed with the Commission on
December 10, 1999 (Commission File No.: 000-22025);
(f) the Company's Current Report on Form 8-K filed with the Commission on
January 19, 2000 (Commission File No.: 000-22025);
(g) the Company's Current Report on Form 8-K filed with the Commission on
March 3, 2000 (Commission File No.: 000-22025); and
(h) the Company's Registration Statement on Form 8-A filed with the
Commission on April 11, 1997 (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.
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SELLING SHAREHOLDER
This prospectus relates to the offering by RGC International Investors, LDC
for resale of up to 3,396,226 shares of common stock. In addition to the
2,264,151 shares of common stock currently owned, the selling shareholder may
acquire 1,132,075 shares upon exercise, from time to time, of the warrants that
it holds. The table below sets forth the following information with respect to
the selling shareholder as of March 1, 2000:
. the name and position or other relationship with Aastrom within the
past three years, if any, of the selling shareholder,
. the number of Aastrom's outstanding shares of common stock
beneficially owned by the selling shareholder (including shares
obtainable under options exercisable within sixty days of such date)
prior to the offering hereby,
. the number of such shares being offered hereby,
. the number and percentage of Aastrom's outstanding shares of common
stock to be beneficially owned by the selling shareholder after
completion of the sale of common stock being offered hereby.
We cannot be sure that the selling shareholder will exercise any of the
warrants or sell any or all of the shares offered hereby.
<TABLE>
<CAPTION>
NUMBER OF SHARES PERCENTAGE OF
BENEFICIALLY OWNED NUMBER OF NUMBER OF SHARES AASTROM STOCK
PRIOR TO THE SUCH SHARES BENEFICIALLY OWNED OWNED AFTER
SELLING SHAREHOLDER OFFERING BEING OFFERED AFTER THE OFFERING THE OFFERING
- ------------------- ------------------ ------------- ------------------ -------------
<S> <C> <C> <C> <C>
RGC INTERNATIONAL INVESTORS, LDC 3,396,226 3,396,226 0 0
</TABLE>
The number of shares set forth in the table represents an estimate of the
number of shares of common stock to be offered by the selling shareholder. Based
on an exercise price of $3.695 on March 1, 2000, the selling shareholder would
receive 1,132,075 shares of common stock upon exercise of the warrants. If the
warrant exercise price decreases 10% to $3.3255, the number of shares issuable
upon exercise of the warrant would increase to 1,257,672, which would dilute the
ownership interests of existing shareholders by approximately .2%. The actual
number of shares of common stock issuable upon exercise of the warrant is
indeterminate and is subject to adjustment. Therefore, the actual number of
shares could be materially less or more than this estimate depending on several
unpredictable factors,
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principally the timing of any future exercises, the market prices of our common
stock shortly before the exercise and financing activities by Aastrom. The
actual number of shares of common stock offered hereby, and included in the
Registration Statement of which this Prospectus is a part, also includes an
additional number of shares of common stock that may be issued or issuable upon
exercise of the warrant by reason of any stock split, stock dividend or similar
transaction involving the common stock, in order to prevent dilution, in
accordance with Rule 416 under the Securities Act.
The number of shares of common stock set forth above as beneficially
owned by the selling shareholder is based on a warrant exercise price of $3.695.
Pursuant to the warrants, the warrants are exercisable by any holder only to the
extent that the number of shares of common stock owned by such holder and its
affiliates after such conversion or exercise would not exceed 9.9% of the then
outstanding common stock as determined in accordance with Section 13(d) of the
Securities Exchange Act. Accordingly, the number of shares of common stock set
forth in the table for the selling shareholder exceeds the number of shares of
common stock that the selling shareholder could own beneficially at any given
time through its immediate exercise of the warrants. In that regard, beneficial
ownership of the selling shareholder set forth in the table is not determined in
accordance with Rule 13d-3 under the Exchange Act.
The selling shareholder, RGC International Investors, LDC, is a party
to an investment management agreement with Rose Glen Capital Management, L.P., a
limited partnership of which the general partner is RGC General Partner Corp.
Messrs. Wayne Bloch, Gary Kaminsky and Steve Katznelson own all of the
outstanding capital stock of RGC General Partner Corp., are the sole officers
and directors of RGC General Partner Corp. and are parties to a shareholders'
agreement pursuant to which they collectively control RGC General Partner Corp.
Through RGC General Partner Corp., these individuals control Rose Glen Capital
Management, L.P. These individuals disclaim beneficial ownership of Aastrom's
Common Stock owned by the selling shareholder.
PLAN OF DISTRIBUTION
The shares of common stock may be offered for sale from time to time by or
on behalf of the holder of those shares. The actual number of shares that may be
offered will vary based on the market price of our common stock, and the
3,396,226 shares covered by this prospectus is based on an assumed warrant
exercise price of $3.695. Because the actual number of shares issued upon
exercise of the warrant may vary, we have registered up to 4,528,302 shares
pursuant to a Registration Statement that includes this Prospectus.
The shares of common stock being offered by the selling shareholder or
its permitted donees, pledgees, transferees, or other successors in interest,
will be sold in one or more transactions (which may involve block transactions)
on the Nasdaq National Market or on such other market on which the common stock
may from time to time be trading:
. in privately-negotiated transactions;
. through the writing of options on the shares;
. short sales; or
. any combination of these transactions.
The shares may also be sold pursuant to Rule 144.
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The sale price may be:
. the market price prevailing at the time of sale;
. a price related to the prevailing market price; or
. such other price as the selling shareholder determines from time to
time.
The selling shareholder may not accept any purchase offer or make any sale of
shares if it considers the purchase price to be unsatisfactory at any particular
time.
The selling shareholder or its permitted donees, pledgees, transferees, or
other successors in interest, may also sell the shares directly to market makers
acting as principals and/or broker-dealers acting as agents for themselves or
their customers. Brokers acting as agents for the selling shareholder will
receive usual and customary commissions for brokerage transactions, and market
makers and block purchasers purchasing the shares will do so for their own
account and at their own risk. The selling shareholder may attempt to sell
shares of common stock in block transactions to market makers or other
purchasers at a price per share which may be below the then current market
price. There can be no assurance that all or any of the shares offered hereby
will be issued to, or sold by, the selling shareholder.
Alternatively, the selling shareholder may sell all or any part of the
shares through an underwriter. The selling shareholder has not entered into any
agreement with a prospective underwriter and may not do so. If the selling
shareholder enters into such an agreement or agreements, Aastrom will supplement
or revise this prospectus.
The selling shareholder and any other persons participating in a
distribution of the shares will be subject to applicable provisions of the
Securities Exchange Act and the rules and regulations thereunder, including
Regulation M, which may restrict certain activities of, and limit the timing of
purchases and sales of the shares by the selling shareholder and other persons
participating in a distribution of the shares. Furthermore, under Regulation M,
persons engaged in a distribution of the shares are prohibited from
simultaneously engaging in market making and certain other activities with
respect to the shares for a specified period of time prior to the commencement
of such distributions subject to specified exceptions or exemptions. All of the
foregoing may affect the marketability of the shares offered hereby.
Aastrom has agreed to indemnify the selling shareholder, or certain
transferees or assignees, against certain liabilities, including liabilities
under the Securities Act, or to contribute to payments the selling shareholder,
or certain transferees or assignees, may be required to make in respect thereof.
The selling shareholder has agreed to indemnify Aastrom against certain
liabilities, including liabilities under the Securities Act, or to contribute to
payments Aastrom may be required to make in respect thereof.
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USE OF PROCEEDS
Aastrom will not receive any proceeds from sales of the shares. We will
receive up to approximately $4.2 million upon exercise of the warrants. This is
based on a potential full exercise of the warrants to purchase 1,132,075 shares
of common stock at $3.695 per share. We intend to apply any net proceeds
received from exercise of the warrants to general working capital purposes.
LEGAL MATTERS
The validity of the common stock offered hereby will be passed upon for
Aastrom by Pepper Hamilton LLP, Detroit, Michigan. Gray Cary Ware & Freidenrich
LLP, San Diego, California, has acted as special counsel to Aastrom in
connection with this offering.
EXPERTS
The financial statements incorporated in this Prospectus by reference to
the Current Report on Form 8-K filed with the Commission on December 10, 1999,
have been so incorporated in reliance on the report (which contains an
explanatory paragraph relating to the Company's ability to continue as a going
concern and described in Note 1 to the Financial Statements) of
PricewaterhouseCoopers LLP, independent accountants, given on the authority of
said firm as experts in auditing and accounting.
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