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Filed Pursuant To Rule 424(b)(3)
File Number: 333-81399
PROSPECTUS
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2,318,275 shares of Common Stock
AASTROM BIOSCIENCES, INC.
This Prospectus relates to the offer and sale of 2,318,275 shares of
common stock being offered by RGC International Investors, LDC. The shares are
issuable upon conversion of shares of our 1999 Series III Convertible Preferred
Stock and upon exercise of warrants issued in connection with the sale of those
shares of preferred stock.
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 September 17, 1999, the
last sale price of the our common stock was $1.625.
INVESTING IN THE COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. YOU
SHOULD CONSIDER CAREFULLY THE RISK FACTORS BEGINNING ON PAGE 3 OF
THIS PROSPECTUS BEFORE MAKING A DECISION TO PURCHASE OUR STOCK.
________________
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 SEPTEMBER 23, 1999.
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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................................. 15
Legal Matters................................... 15
Experts......................................... 15
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SUMMARY
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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
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Aastrom develops proprietary process technologies and devices for a range
of cell therapy applications. The AastromReplicell 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. Commercialization of the AastromReplicell System for use in
stem cell therapy has begun in Europe. Aastrom believes that the
AastromReplicell 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 System is designed as a platform product which implements
Aastrom's pioneering stem cell replication technology. Aastrom believes that the
AastromReplicell 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. Aastrom believes that the
AastromReplicell System will offer significant advantages over traditional stem
cell collection methods. The AastromReplicell System is intended to be used to
produce cells used 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
System process, the presence of breast cancer cells in each sample was either
substantially reduced or was no longer detectable. Aastrom believes that the
combination of passive tumor cell depletion during culture with the lower
starting volume cells used for the procedure may result in a procedure that
offers a tumor-free or tumor-reduced cell product for transplant. Although
Aastrom may not market the AastromReplicell System in the United States for stem
cell therapy unless and until it receives FDA and other necessary regulatory
approvals, Aastrom has already completed production-level versions of the
AastromReplicell System and has obtained permission to affix the CE Mark to such
versions. This has allowed Aastrom to initiate a limited product launch in
Europe.
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
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Common stock offered by the selling
shareholder.................................................... 2,318,275 shares
For purposes of estimating the number of shares of common stock covered by
this Prospectus Aastrom calculated the number of shares of common stock issuable
in connection with the conversion of Series III Shares (based on a conversion
price of $1.5124, which is the average of the closing bid prices of the common
stock reported on the Nasdaq National Market for the lowest five consecutive
trading days during the twenty trading days preceding September 17, 1999) and
added the number of shares issuable upon exercise of the warrants issued in
connection with the sale of the Series III 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.
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 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 limited basis of the Aastrom Replicell 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 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 happen, 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 System. 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 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.
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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 (the
"FDA") before commercial sales of Aastrom's 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 the physicians involved, unrelated to the Aastrom Replicell 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 May Impair Our Business.
Aastrom's product development efforts are primarily directed toward
obtaining regulatory approval to market the AastromReplicell 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. 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, Aastrom may not be able to continue its present arrangements with
its suppliers, supplement existing relationships, establish new relationships or
be able to identify and obtain the ancillary materials that are necessary to
develop its product candidates in the future. Aastrom's dependence upon third
parties for the supply and manufacture of such items could adversely affect
Aastrom's 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 June 30, 1999, Aastrom has incurred net
operating losses totaling approximately $69.6 million. These losses have
resulted principally from costs incurred in the research and development of
Aastrom's cell culture technologies and the AastromReplicell 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 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,
Aastrom and COBE BCT recently terminated their strategic alliance for the
worldwide distribution of the AastromReplicell 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.
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. Aastrom anticipates that its available
cash and expected interest income will be sufficient to finance the development
and manufacture of the AastromReplicell System for use in clinical trials,
expanded clinical trials, other research and development and working capital and
other corporate requirements into early 2000. This estimate is based on certain
assumptions which could be negatively impacted by the matters discussed under
this heading and elsewhere under the caption "Risk Factors." 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 to finance the research and
development activities of Aastrom's product candidates for the expansion of
additional cell types.
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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,
. possible changes in existing collaborative relationships,
. the ability of Aastrom to establish additional collaborative
relationships, and
. effective commercialization activities and facilities 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. This
additional funding may not be available to Aastrom on reasonable terms, or at
all. If adequate funds are not available, Aastrom may be required to delay or
terminate research and development programs, curtail capital expenditures, and
reduce business development and other operating activities.
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 System for stem cell therapy as a Class III medical device, the
FDA may ultimately choose to regulate the AastromReplicell 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.
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 can not 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.
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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 assure you
that patents will be granted on any of our pending or future patent
applications. We also cannot assure you 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, or 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 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 Products 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 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
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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. We may not be successful in hiring or
retaining key personnel.
The Series III Shares and Other Outstanding Shares of Preferred Stock Share Have
the Potential for Substantial Dilution.
The Series III shares and the other outstanding shares of preferred stock
are each convertible into a number of shares of common stock that increases as
the current market price of the common stock decreases. If the selling
shareholder was able to and did convert all of its Series III shares and other
outstanding shares of preferred stock as of September 17, 1999, the selling
shareholder would have received approximately 5,020,562 shares of common stock.
This number of shares could become significantly greater in the event of a
decrease in the trading price of the common stock. Purchasers of common stock
could therefore experience substantial dilution of their investment upon
conversion of the Series III shares and the other outstanding shares of
preferred stock. The Series III shares and other outstanding shares of
preferred stock 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. The shares of common stock into which the
Series III shares may be converted are being registered pursuant to this
Registration Statement.
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
. changes in 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 approximately 40% 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
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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 the Series III Shares, Which Would
Significantly Reduce Our Limited Cash Resources.
The holders of Series III shares may require us to redeem some or all of
those shares. These redemption rights would be triggered if we fail to issue
shares of common stock on conversion of the Series III Preferred, if we fail to
maintain the effectiveness of a registration statement for the resale of those
shares of common stock, if we are subject to bankruptcy or insolvency
proceedings, if we fail to maintain our listing on the Nasdaq stock market, or
if we fail to obtain shareholder approval of the issuance of the Series III
shares and the conversion of those Series III shares would result in the
issuance of more than 3,098,825 shares of common stock. Any redemption would
reduce our available cash resources, which are already very limited.
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.
Year 2000 Issues May Adversely Affect Our Computer Systems and Our Business.
Many currently installed computer systems and software products cannot
distinguish 20th century dates from 21st century dates. As a result, some
computer systems and/or software will experience operating difficulties unless
they are modified or upgraded to adequately process information involving,
related to, or dependent upon the century change. In light of the potentially
broad effects of the year 2000 on a wide range of business systems, we may be
affected. We utilize and are dependent upon data processing computer hardware
and software to conduct our business. We have completed an assessment of our
own computer systems and based upon this assessment, we believe our computer
systems are substantially "Year 2000 compliant;" that is, our computer systems
are capable of adequately distinguishing 21st century dates from 20th century
dates. However, we may not have identified all significant Year 2000 problems
in our computer systems, and therefore may be subject to unknown risk and
expense. Based on our internal assessment, we believe that the most likely
worst case scenario would involve our suppliers and manufacturers. We have not
determined the extent, or completed activities to minimize the risk of the
computer systems of our suppliers and manufacturers being not Year 2000
compliant, or not becoming compliant on a timely basis. We expect to make
inquires with these suppliers through the end of 1999. Year 2000 problems could
prevent any of our suppliers from timely delivery of products or services that
we need. We currently believe that our costs to address the Year 2000 issue
relating to our suppliers will not be material, and that these costs will be
funded from our operating cash flows. To the extent practical, we intend to
identify alternative suppliers and manufacturers in the event our preferred
suppliers cannot deliver products or services that we need on a timely basis.
Our expectations of Year 2000 costs relating to our suppliers and manufacturers
are only estimates, which were derived from numerous assumptions of future
events, including the continued availability of resources and
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third-party remediation plans with regard to year 2000 issues. These estimates
may not be correct and actual results could differ materially from these
estimates.
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 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;
. future capital needs and uncertainty of additional funding;
. 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.
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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); and
(b) the Company's Registration Statement on Form 8-A (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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<PAGE>
SELLING SHAREHOLDER
This prospectus relates to the offering by RGC International Investors, LDC
for resale of up to 2,318,275 shares of common stock. The selling shareholder
will acquire the shares upon (a) conversion, from time to time, of the Series
III shares that it acquired in May 1999, and (b) 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 September 17, 1999:
. 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.
The number of shares reported as being beneficially owned after the
offering represents shares of common stock issuable upon conversion of another
outstanding series of preferred stock and exercise of the warrants. These shares
of common stock have been registered for sale and they may be sold before or
after the shares that may be sold pursuant to this prospectus. We cannot assume
that the selling shareholder will convert any Series III shares or 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
Selling Shareholder Offering Being Offered After the Offering After the Offering
- ------------------- ------------------ ------------- ------------------ ------------------
<S> <C> <C> <C> <C>
RGC International 5,320,562 2,318,275 3,002,287 13.5
Investors, LDC
</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 a conversion price of $1.5124 on September 17, 1999, the selling shareholder
would receive 2,018,275 shares of common stock upon conversion of the Series III
shares. This prospectus covers the sale of all 2,318,275 of the shares of common
stock we expect to be issued to the selling shareholder based on the current
conversion price and on exercise of the warrants. If the conversion price
decreases 10% to $1.36116, the number of shares issuable upon conversion of the
Series III shares would increase to 2,242,527, which would dilute the ownership
interests of existing shareholders by approximately 1.2%. The actual number of
shares of common stock issuable upon conversion of Series III shares and of the
other outstanding series of preferred stock 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, principally
the timing of any future conversions and the market prices of the common stock
shortly before the conversion. We have therefore registered, under a
registration statement on Form S-3 of which this prospectus is a part, 1,476,599
more shares than are covered by this prospectus to account for potential
adjustments. These additional shares may only be sold by the selling shareholder
after we reflect the change in the number of shares offered in a supplement to
this prospectus. 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
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<PAGE>
issuable upon conversion of the Series III shares 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 conversion price of $1.5124. The
conversion price reflects the average of the closing bid prices of the common
stock for the lowest five consecutive trading days during the twenty trading
days preceding Sepember 17, 1999, multiplied by 100% pursuant to the terms of
the Series III shares. Pursuant to our charter documents and the warrants, the
Series III shares are convertible and 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 (but not including shares of common stock underlying
unconverted Series III shares) after such conversion or exercise would not
exceed 4.9% 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 ownership of Series III shares or
our other outstanding series of preferred stock. 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 after
conversion of the Series III Shares or exercise of the warrants 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 2,318,275
shares covered by this prospectus is based on an assumed conversion price of
$1.5124. Because the actual number of shares issued upon conversion of the
Series III shares may vary, we have registered up to 3,794,874 shares pursuant
to a Registration Statement that includes this Prospectus.
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 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 shares may also be sold pursuant to Rule 144.
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.
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<PAGE>
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.
USE OF PROCEEDS
Aastrom will not receive any proceeds from sales of the shares or from any
conversions of the Series III shares.
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 Annual Report on Form 10-K for the year ended June 30, 1999 have been so
incorporated in reliance on the report of PricewaterhouseCoopers LLP,
independent accountants, given on the authority of said firm as experts in
auditing and accounting.
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