posam
As filed with the Securities and Exchange Commission on March 31, 2010.
Registration No. 333-160044
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Post Effective Amendment No. 1
to
FORM S-1
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
AASTROM BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Michigan
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94-3096597 |
(State or other jurisdiction of
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(I.R.S. Employer Identification |
incorporation or organization)
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Number) |
24 Frank Lloyd Wright Drive
P.O. Box 376
Ann Arbor, Michigan 48106
(734) 930-5555
(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)
Timothy M. Mayleben
President and Chief Executive Officer
Aastrom Biosciences, Inc.
24 Frank Lloyd Wright Drive
P.O. Box 376
Ann Arbor, Michigan 48106
(734) 930-5555
(Name, address, including zip code, and telephone number, including area code, of agent for service)
With a copy to:
Mitchell S. Bloom
Danielle M. Lauzon
Goodwin Procter LLP
Exchange Place
Boston, Massachusetts 02109
Telephone: (617) 570-1000
Facsimile: (617) 523-1231
Approximate date of commencement of proposed sale to the public: From time to time after this
Registration Statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933 check the following
box: þ
If this form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act, please check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act,
check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act,
check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(Do not check if a smaller reporting company) |
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THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE
NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT HAS FILED A FURTHER AMENDMENT THAT
SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN
ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT
SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION ACTING PURSUANT TO SAID SECTION 8(A), MAY
DETERMINE.
EXPLANATORY NOTE
This Post-Effective Amendment No. 1 to Form S-1 (this Post-Effective Amendment) is being
filed by Aastrom Biosciences, Inc. (the Company) pursuant to the undertakings in Item 17 of the
registration statement on Form S-1 (Registration No. 333-160044) (the Registration Statement),
which was previously declared effective by the Securities and Exchange Commission on June 29, 2009,
to (i) incorporate by reference the Companys Annual Report on Form 10-K for the fiscal period
ended June 30, 2009, the Quarterly Reports on Form 10-Q for the fiscal periods ended September 30,
2009 and December 31, 2009, as well as several Current Reports on Form 8-K, and (ii) update certain
other information in the Registration Statement, including the impact of a one-for-eight reverse
stock split effected on February 18, 2010 (the Reverse Stock Split). No additional securities are
being registered under this Post-Effective Amendment. Unless otherwise stated herein, all
historical share amounts and prices in this Post-Effective Amendment have been adjusted to give
retroactive effect to the Reverse Stock Split. All applicable registration fees were paid at the
time of the original filing of the Registration Statement. Accordingly, we hereby amend the
Registration Statement by filing this Post-Effective Amendment, which, after giving effect to the
Reverse Stock Split, relates to the registration of 4,984,079 shares of our common stock, no par
value per share, being registered for resale by the selling shareholder listed herein.
The information in this prospectus is not complete and may be changed. The securities covered
by this prospectus may not be sold until the registration statement filed with the Securities and
Exchange Commission is effective. This prospectus is not an offer to sell these securities and we
are not soliciting offers to buy these securities in any state where the offer or sale is not
permitted.
SUBJECT TO COMPLETION, DATED MARCH 31, 2010.
PROSPECTUS
AASTROM BIOSCIENCES, INC.
4,984,079 Shares of Common Stock
This prospectus relates to the sale of up to 4,984,079 shares of our common
stock by Fusion Capital Fund II, LLC, or Fusion Capital. The common stock covered by this
prospectus consists of shares of common stock that have been issued or may be issued to Fusion
Capital under that common stock purchase agreement dated as of June 12, 2009. Fusion Capital is
sometimes referred to in this prospectus as the selling shareholder. The prices at which Fusion
Capital may sell the shares will be determined by the prevailing market price for the shares or in
negotiated transactions. We will not receive proceeds from the sale of our shares by Fusion
Capital.
Our common stock is registered under Section 12(b) of the Securities Exchange Act of 1934 and
quoted on the Nasdaq Capital Market under the symbol ASTM. On March 30, 2010, the last reported
sale price for our common stock as reported on the Nasdaq Capital Market was $1.64 per share. Our
principal executive offices are located at 24 Frank Lloyd Wright Drive, Ann Arbor, Michigan, 48106
and our telephone number is (734) 930-5555.
Investing in our common stock involves risks. You should carefully consider the risk
factors beginning on page 7 of this prospectus before you make an investment in our common stock.
The selling shareholder is an underwriter within the meaning of the
Securities Act of 1933, as amended.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
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The date of this Prospectus is , 2010. |
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You should read this prospectus, any applicable prospectus supplement and
the information incorporated by reference in this prospectus before making an investment in the
common stock of Aastrom Biosciences, Inc. See Where You Can Find Additional Information for more
information, page 15. You should rely only on the information contained in or incorporated by
reference in this prospectus or a prospectus supplement. We have not authorized anyone to provide
you with different information. This document may be used only in jurisdictions where offers and
sales of these securities are permitted. You should assume that information contained in this
prospectus, or in any document incorporated by reference, is accurate only as of any date on the
front cover of the applicable document. Our business, financial condition, results of operations
and prospects may have changed since that date.
PROSPECTUS SUMMARY
The following summary highlights information contained elsewhere in this prospectus. It may
not contain all of the information that is important to you. You should read the entire prospectus
carefully, especially the discussion regarding the risks of investing in our common stock under the
heading Risk Factors, before investing in our common stock. In this prospectus, Aastrom, we,
us, and our refer to Aastrom Biosciences, Inc.
On February 18, 2010, we effected a one-for-eight reverse stock split of our common stock.
Unless otherwise stated herein, all historical share amounts and prices in this prospectus have
been adjusted to give retroactive effect to this reverse stock split.
Business
We focus on the development of innovative therapies to repair or regenerate damaged or
diseased tissues or organs. We are developing autologous cellular therapies for the treatment of
severe, chronic cardiovascular diseases. Using our proprietary Tissue Repair Cell (TRC) technology,
we are able to expand the number of stem and early progenitor cells from a small amount
(approximately 50 ml) of bone marrow collected from the patient. Early stage and clinical research
show that these cells may have efficacy in the repair of cardiac and other tissue.
With the use of our proprietary TRC technology, we produce personalized cell products
developed for site-specific delivery to repair or regenerate diseased or damaged tissue in
patients. More than 375 patients have been treated in clinical trials based on this therapeutic
approach over the past 10 years with no reported incidence of product safety problems or tissue
rejection.
Cardiac Regeneration
Our lead product is based on the application of autologous stem cells used to repair damaged
cardiac tissue. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to
our investigational therapy involving the use of TRCs in the treatment of dilated cardiomyopathy
(DCM). DCM is a severe, chronic cardiac disease that leads to enlargement of the heart and is
associated with reduced heart pumping function to the point that blood circulation is impaired. We
have advanced this development program with two U.S. Phase II trials investigating both a surgical
and a catheter-based delivery pathway for the use of CRCs in the treatment of DCM.
The first U.S. patient was treated with TRCs in our Phase II IMPACT-DCM surgical clinical
trial in November 2008. As of January 31, 2010, the trial was fully enrolled with 40 patients who
will be followed for one year. The study is being conducted at five cardiovascular treatment
centers in the U.S., including: Methodist DeBakey Heart & Vascular Center in Houston, TX; Baylor
University Medical Center in Dallas, TX; The University of Utah School of Medicine in Salt Lake
City, UT; Cleveland Clinic Heart & Vascular Institute in Cleveland, OH; and Emory University
Hospital Midtown in Atlanta, GA. We anticipate reporting the results
of an interim analysis of 6 month patient data in the fourth quarter of calendar
year 2010.
Our second cardiac trial, a U.S. Phase II cardiac catheter clinical trial has been designed to
explore a catheter-based delivery of TRCs to treat DCM patients. Clinical site training for this
trial was initiated during the fourth quarter of calendar year 2009, and we expect to begin
enrolling patients in April 2010.
Vascular Regeneration
Our TRC technology has also shown promise in the treatment of an advanced stage of peripheral
arterial disease (PAD) called critical limb ischemia (CLI). Patients with CLI generally have
painful wounds on their feet that do not heal due to poor blood circulation, often
leading to amputation. More than 160,000 amputations per year are associated with CLI. Our U.S.
Phase IIb RESTORE-CLI clinical trial is investigating the safety and efficacy of TRCs in the
treatment of patients with this severe, chronic disease compared with placebo; neither patients nor
physicians know the treatment received during the study.
In February 2010 a planned interim analysis was performed for this study on 46 patients having
completed at least 6 months of the study. According to the interim analysis, the safety profile
was similar between the treatment and placebo patients. Based on a composite efficacy endpoint
assessing time to treatment failure (including major amputations, doubling of wound size and new
gangrene), our autologous TRCs were more effective than placebo (p<0.05). Other clinically
meaningful endpoints (e.g., major amputation rate, complete wound healing) individually showed
encouraging trends, but have not yet reached statistical significance at the interim analysis.
The interim analysis was planned to assess performance of TRCs and to help plan further
studies. Based on the interim findings, we concluded enrollment of new patients in order to
complete the study as soon as possible, and to begin planning and discussions with the FDA for
pivotal clinical trials in CLI. The last patient enrolled in this trial was treated on
March 23, 2010, for a total of 86 patients who will be followed for 12 months.
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The TRC Technology Platform
TRCs are a cellular therapy developed using our proprietary TRC technology, an automated
processing system utilizing single-pass perfusion to manufacture human cell products for clinical
use. The system meets all Good Manufacturing Practices (GMP) guidelines. TRC-based therapies begin
with a small amount of the patients own bone marrow to produce large numbers of stem and early
progenitor cells. This mixture of cell types is capable of developing into cardiac, vascular and
other tissues.
Our cell products have three features that we believe are critical for success in regenerative
medicine. Cellular therapies based on our TRC technology are:
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autologous, which means we start with the patients own
cells, which are accepted by the patients immune system
allowing the cells to differentiate and integrate into
existing functional tissues.
Long-term engraftment is expected to support repair of damaged tissue; |
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expanded, resulting in significantly higher concentrations
of stem and progenitor cells than occur naturally,
especially for older patients; and, |
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a mixed population of cells, which includes all of the
most important cell types required for tissue regeneration
and found in natural bone marrow and are required for
tissue regeneration. |
All TRC-based products are manufactured at centralized facilities. We have our primary cell
processing facility in the U.S. located at our headquarters in Ann Arbor, MI, and two contract
facilities in the E.U. located in Stuttgart, Germany (Fraunhofer Institute for Interfacial
Engineering and Biotechnology) and Bad Oeynhausen, Germany (Institute of Laboratory and Transfusion
Medicine at the Heart Center).
Since our inception, we have been a development-stage company engaged in research and product
development conducted principally on our own behalf. We are focused the development of products
based on our TRC technology platform for use in cardiovascular indications. We currently generate
minimal product sales involving cell-therapy based products to physicians in the United States. At
such time as we satisfy applicable regulatory approval requirements, we expect the sales of
therapies based on our TRC technology platform to constitute nearly all of our revenue from product
sales.
We do not expect to generate positive cash flows from our consolidated operations for at least
the next several years and then only if we achieve significant TRC-based cell product sales. Until
that time, we expect that revenue sources from our current activities will consist of only minor
sales of our cell products to our academic collaborators, grant revenue, research funding and
potential licensing fees or other financial support from potential future corporate collaborators.
We expect that we will need to raise significant additional funds or pursue strategic
alliances or other operational strategies to advance our product development programs including
completion of our clinical research programs and commercialization of our products. To date, we
have financed our operations primarily through public and private sales of our equity securities,
and we expect to continue to seek to obtain required capital in a similar manner. As a
development-stage company, we have never been profitable and do not anticipate having net income
unless and until significant product sales are achieved. With respect to our current activities,
profitability is not likely to occur until we obtain significant additional funding, complete the
required clinical trials for regulatory approvals and receive the necessary approvals to market our
products. Through December 31, 2009, we have accumulated a net loss of approximately $203 million.
We cannot provide any assurance that we will achieve profitability or obtain the required funding,
regulatory approvals or complete additional corporate partnering or acquisition transactions to
advance our products to commercial-stage development.
Clinical Development
Our clinical development programs are focused on the utilization of our TRCs for cardiac and
vascular regeneration. Our TRC-based cell therapies have a 72-hour shelf-life which we believe
provides additional flexibility in transport and scheduling treatment for patients.
The mixture of cell types in TRC-based therapies is capable of developing into cardiac,
vascular and other tissues. We have demonstrated in the laboratory that cells in TRC-based
therapies can differentiate into endothelial (blood vessel) lineages. In addition, TRC treatment in
both rat and mouse models of critical limb ischemia have shown evidence of angiogenesis and
increased tissue perfusion, respectively. These preclinical observations support our current
clinical-stage research at treatment centers where we are exploring the use of TRC-based therapies
to regenerate cardiac tissue in patients with dilated cardiomyopathy and vascular tissue in
patients with critical limb ischemia.
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Results to date in our current clinical trials may not be indicative of results obtained from
subsequent patients in those trials or from future clinical trials. Further, our future clinical trials may not be successful and we
may not be able to obtain the required Biologic License Application (BLA) registration in the U.S.
or required foreign regulatory approvals for our TRC-based products in a timely fashion, or at all.
See Risk Factors.
Clinical Trials Summary
Cardiac Regeneration
Dilated Cardiomyopathy Background
DCM is a severe, chronic cardiac disease that leads to enlargement of the heart and is
associated with reduced heart pumping function to the point that blood circulation is impaired.
Patients with DCM typically present with symptoms of congestive heart failure, including
limitations in physical activity and shortness of breath. DCM generally occurs in patients who have
ischemic heart failure due to multiple heart attacks, though it can also be found in patients with
non-ischemic heart failure caused by hypertension, viral infection, metabolic abnormalities and
other causes. Patient prognosis depends on the stage of the disease but is typically characterized
by a high mortality rate. Other than heart transplantation, there are currently no curative
treatment options for end-stage patients with this disease. The New England Journal of Medicine
estimates that in the U.S. alone 120,000 people currently suffer from this disease; other sources
estimate that the patient population with DCM may be as high as 150,000.
Early clinical data in the treatment of DCM with TRCs was obtained from two DCM patients
treated in 2007 at the University Hospital in Düsseldorf, Germany. These two patients showed 15-20%
improvement in their left ventricular ejection fraction approximately 2 months after treatment with
TRCs. One patient maintained this improvement after 7 months of follow-up; however, the other died
due to natural causes after declining further medical treatment. These data provided supportive
information critical to the success of the U.S. Phase II IMPACT-DCM IND application.
Dilated Cardiomyopathy Surgical Trial
In November 2008, the first patient was treated in the 40-patient U.S. IMPACT-DCM surgical
trial to evaluate TRCs in the treatment of DCM. This randomized, controlled, prospective,
open-label, Phase II study was designed using two strata to include 20 patients with ischemic DCM
and 20 patients with non-ischemic DCM. TRCs, manufactured using our TRC technology, received Orphan
Drug Designation from the FDA for the treatment of DCM in February 2007. The FDA activated our
Investigational New Drug (IND) application for this clinical trial in May 2008.
The IMPACT-DCM
study is fully enrolled, with the final patient treated in March 2010.
Patients
were enrolled at five U.S. clinical sites (Methodist DeBakey Heart & Vascular Center, Houston, TX,
Baylor University Medical Center, Dallas, TX, The University of Utah School of Medicine, Salt Lake
City, UT, Cleveland Clinic Heart & Vascular Institute, Cleveland, OH, and Emory University Hospital
Midtown, Atlanta, GA). We anticipate reporting the results of an interim analysis of 6 month patient data in the fourth quarter of calendar
year 2010.
Participants in the IMPACT-DCM clinical trial have to be in New York Heart Association (NYHA)
functional class III or IV heart failure, must have an LVEF of less than or equal to 30% (60-75% is
typical for a healthy person), and meet certain other eligibility criteria. The IMPACT-DCM trial is
a controlled trial and patients are randomized in an approximate 3:1 ratio to the treatment versus
the control group within each stratum. All patients receive optimal medical therapy and patients in
the treatment group are treated with CRCs through direct injection into the heart muscle during
minimally invasive open heart surgery (involving an incision of approximately 2 inches). While the
primary objective of this study is to assess the safety of TRCs in patients with DCM (including the
incidence of ectopy and arrhythmia as well as major adverse cardiac events), efficacy measures
including cardiac dimensions and tissue mass, cardiac function (e.g. cardiac output, LVEF,
cardiopulmonary exercise testing parameters), cardiac perfusion and viability as well as other
efficacy endpoints will be monitored. NYHA functional class and quality of life are also assessed.
Patients will be followed for 12 months post-treatment.
Dilated Cardiomyopathy Catheter Trial
We have expanded our ongoing clinical program to evaluate TRCs in the treatment of severe
heart failure patients with a second U.S. Phase II cardiac regeneration trial designed to explore a
catheter-based delivery of TRCs to treat DCM patients. The FDA activated our IND application for
this clinical trial in November 2009. The first clinical site was trained in December 2009 and
patient enrollment is expected to begin during April 2010.
This randomized, controlled, prospective, open-label, Phase II study seeks to enroll 12
patients with ischemic DCM and 12 patients with non-ischemic DCM at four clinical sites in the U.S.
Participants must be in NYHA functional class III or IV heart failure, must have an LVEF of less
than or equal to 30% (60-75% is typical for a healthy person) and meet certain additional
eligibility criteria. All 24 patients will receive optimal medical therapy and 16 of the patients
(8 ischemic and 8 non-ischemic) will also be treated with TRCs via catheter injection. The catheter
trial will randomize patients in an approximate 2:1 ratio to the treatment versus
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control group within each stratum. While the primary objective of this study is to assess the
safety of TRCs delivered by catheter injection in patients with DCM, efficacy measures including
heart failure stage and cardiac function parameters will also be assessed. Patients will be
followed for 12 months post-treatment.
Vascular Tissue Regeneration
Critical Limb Ischemia Background
Peripheral Arterial Disease (PAD) is a chronic disease that progressively restricts blood flow
in the limbs and can lead to serious medical complications. This disease is often associated with
other clinical conditions, including hypertension, cardiovascular disease, hyperlipidemia,
diabetes, obesity and stroke. CLI is used to describe patients with the most severe forms of PAD:
those with chronic ischemia-induced pain (even at rest), ulcers, tissue loss or gangrene in the
limbs. CLI is typically the end stage of PAD disease. Patients suffering from this condition are
critically ill, with a high risk of amputation. These patients are extremely limited in their
ambulatory capacity, experience constant and chronic ischemia-induced pain, ulcers, tissue loss or
gangrene to the limbs, which lead to approximately 160,000 amputations per year.
Laboratory observations have shown that TRC-based products have the ability to form small
blood vessel-like structures in vitro. TRC treatment in both rat and mouse models of critical limb
ischemia have shown evidence of angiogenesis and increased tissue perfusion, respectively. These
preclinical observations support our current clinical-stage research where we are exploring the use
of TRC therapies to regenerate vascular tissue in patients with CLI.
The first evaluation of TRCs was conducted in a small clinical trial in Germany. Initial
results from this study were reported in October 2007 at the 2nd Congress of the German Society for
Stem Cell Research in Würzburg, Germany, by the studys Principal Investigator from the Heart &
Diabetes Center in Bad Oeynhausen, Germany. This interim report provided results from the first 13
patients treated in a 30-patient, multi-arm Phase I/II single-center clinical trial to evaluate the
safety of TRCs and unexpanded bone marrow cells in the treatment of chronic diabetic foot wounds
associated with CLI. As presented, results reflect treatment experience from 4 diabetic patients
with ischemia-related chronic tissue ulcers who were treated with TRCs, 7 patients who were treated
with normal unexpanded marrow cells, and two standard-of-care patients who did not receive cells.
All patients received wound care according to treatment standards outlined by the American Diabetes
Association. Twelve months post-treatment, all patients in the interim analysis who were treated
with TRCs reported no major amputations, no cell-related adverse events, and healing of all open
wounds. Of the 7 patients treated with unexpanded bone marrow cells, 5 reported results similar to
the TRC-treated patients 12 months post-treatment, 1 reported similar results to the TRC-treated
patients 18 months post-treatment, and 1 patient underwent a major amputation. For the 2
standard-of-care patients who only received wound care (no cells), 1 patient received a major
amputation and 1 patient experienced no improvement in wound healing after 12 months. Patient
follow-up has been completed and final data are expected to be reported by the investigator.
Critical Limb Ischemia Trial
Following the interim clinical results from Germany, we initiated the RESTORE-CLI trial, a
U.S. Phase IIb prospective, controlled, randomized, double-blind, multi-center clinical trial to
treat patients suffering from CLI. This trial is designed to enroll up to 150 patients at up to 30
sites. Patients are randomized into two groups (treatment or placebo control) to evaluate the
safety and efficacy of TRCs in the treatment of CLI. Patients are being followed for a period of 12
months post-treatment. In addition to assessing the safety of TRCs, secondary endpoints include the
measurement of time to treatment failure, major amputation rates, level of amputation, complete
wound healing, blood flow in affected limbs, patient quality of life, pain scores and analgesic
use.
In February 2010 a planned interim analysis was performed for this study on 46 patients having
completed at least 6 months of the study. We reported the safety profile was similar between the
treatment and control patients. Importantly, we reported that our autologous TRCs were more
effective than placebo (p<0.05), based on a composite efficacy endpoint assessing time to
treatment failure (including major amputations, doubling of wound size or new gangrene). Other
clinically meaningful endpoints (e.g., major amputation rate, complete wound healing) individually
showed encouraging trends, but have not yet reached statistical significance at the interim
analysis.
The interim analysis was planned to assess performance of TRCs in the CLI patient population
and to help plan further studies. Based on the interim findings, we concluded enrollment of new
patients in February 2010 in order to complete the study as rapidly as possible, and to begin
planning and discussions with the FDA for pivotal clinical trials in CLI. The last patient enrolled
in this trial was treated on March 23, 2010.
Corporate Information
Aastrom is incorporated under the laws of the State of Michigan. Our principal executive
offices are located at 24 Frank Lloyd Wright Drive, Ann Arbor, Michigan 48106. Our telephone number
is (734) 930-5555. The address of our website is http://www.aastrom.com. Except for those
documents explicitly incorporated by reference herein, information available on or through our website is not part of this prospectus.
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Our Common Stock
Our common stock, no par value, trades on the Nasdaq Capital Market under the symbol ASTM.
The Offering
This prospectus relates to the resale by the selling shareholder identified in this prospectus
of up to 4,984,079 shares of common stock. All of the shares, when sold, will be sold by the
selling shareholder. The prices at which the selling shareholder may sell the shares will be
determined by the prevailing market price for the shares or in negotiated transactions. We will
not receive any proceeds from the sale of the shares by the selling shareholder.
On June 12, 2009, we entered into a Common Stock Purchase Agreement, or Purchase Agreement,
with Fusion Capital, an Illinois limited liability company. Under the Purchase Agreement, Fusion
Capital is obligated, under certain conditions, to purchase shares from us in an aggregate amount
of $30.0 million from time to time over a 25-month period. Under the terms of the Purchase
Agreement, Fusion Capital has received an initial commitment fee consisting of 181,529 shares of
our common stock. Also, under the Purchase Agreement, we will issue to Fusion Capital up to an
additional 302,549 shares as a commitment fee pro rata as we receive the $30.0 million of future
funding. As of March 24, 2010, 1,900,083 shares of our common stock (including 232,962 shares
related to the commitment fee) were issued to Fusion Capital for net proceeds of $5.1 million. As
of March 24, 2010, there were 28,255,889 shares outstanding (28,196,584 shares held by non-
affiliates) excluding the 2,832,879 shares registered under this registration statement that can be
sold to Fusion and the 251,117 shares of additional commitment shares that Fusion Capital has not
yet received from us. If all of such shares offered hereby were issued and outstanding as of the
date hereof, the 4,984,079 shares (which includes the 1,900,083 shares already issued) would
represent 17.64% of the total common stock outstanding or 17.68% of the non-affiliate shares
outstanding as of the date hereof.
Under the Purchase Agreement and the Registration Rights Agreement, dated as of June 12, 2009
by and between Aastrom and Fusion Capital, or the Registration Rights Agreement, we are required to
register and have included in the offering pursuant to this prospectus (1) 1,900,083 shares which
have already been issued through the date hereof (including 232,962 shares related to the
commitment fee), (2) an additional 251,117 shares which we may issue in the future as a commitment
fee pro rata as we receive the future funding under the Purchase Agreement and (3) at least
2,832,879 shares which we may sell to Fusion Capital (not including the additional commitment fee
shares). All 4,984,079 shares are being offered pursuant to this prospectus. Under the Purchase
Agreement, we have the right but not the obligation to sell more than the 4,500,000 shares to
Fusion Capital. The number of shares ultimately offered for sale by Fusion Capital is dependent
upon the number of shares purchased by Fusion Capital under the Purchase Agreement.
Generally, we have the right but not the obligation from time to time to sell our shares to
Fusion Capital in amounts between $100,000 and $4.0 million depending on certain conditions. We
have the right to control the timing and amount of any sales of our shares to Fusion Capital. The
purchase price of the shares will be determined based upon the market price of our shares without
any fixed discount at the time of each sale. Fusion Capital shall neither have the right nor the
obligation to purchase any shares of our common stock on any business day that the price of our
common stock is below $0.80.
Additionally, in order to be in compliance with Nasdaq Capital Market rules, we cannot be
required to sell, and Fusion Capital shall not have the right or the obligation to purchase, shares
of our common at a price below $2.88, which represents the greater of the book value per share of
our common stock as of March 31, 2009 or the closing sale price per share of our common stock on
June 11, 2009, the business day before we entered into the Purchase Agreement, plus $0.08. If we
elect to sell our shares of common stock to Fusion Capital at a price per share below $2.88, we may
be required to obtain shareholder approval in order to be in compliance with the Nasdaq Capital
Market rules.
There are no negative covenants, restrictions on future fundings, penalties or liquidated
damages in the Purchase Agreement or the Registration Rights Agreement. The Purchase Agreement may
be terminated by us at any time at our discretion without any cost to us.
In January 2010, we completed an underwritten public offering of common stock and warrants.
Pursuant to the underwriting agreement with Oppenheimer & Co., Inc., we have agreed not to issue or
sell any securities under the Purchase Agreement with Fusion Capital for a period of 180 days from
January 15, 2010 without the prior written consent of Oppenheimer & Co. Inc.
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INCORPORATION BY REFERENCE
This prospectus incorporates by reference important business and financial information that we
file with the Securities and Exchange Commission, or the SEC, and that we are not including in or
delivering with this prospectus. As the SEC allows, incorporated documents are considered part of
this prospectus, and we can disclose important information to you by referring you to those
documents. The documents incorporated herein by reference are:
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our Annual Report on Form 10-K for the fiscal year ended June 30, 2009 filed with the SEC on September 14, 2009; |
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the portions of our definitive Proxy Statement, filed with the SEC on October 27, 2009, for our Annual Meeting
of Shareholders held on December 14, 2009 that have been incorporated by reference into the Form 10-K for the
fiscal year ended June 30, 2009; |
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our Quarterly Reports on Form 10-Q for the quarters ended September 30, 2009 and December 31, 2009 filed with
the SEC on November 6, 2009, February 9, 2010, respectively; and |
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our Current Reports on Form 8-K filed with the SEC on September 8, 2009 (Item 5.02 only), October 7, 2009,
October 20, 2009, October 27, 2009, December 17, 2009, January 15, 2010, January 27, 2010, and February 9,
2010, February 18, 2010, February 24, 2010 and March 5, 2010. |
Information in this prospectus supersedes related information in the documents listed above.
We will provide to each person, including any beneficial owner, to whom a copy of this
prospectus is delivered, upon request, a copy of any and all of the documents incorporated by
reference in this prospectus. You may request a copy of any or all of these documents, which will
be provided at no cost, by written request to: Aastrom Biosciences, Inc., 24 Frank Lloyd Wright
Drive, P.O. Box 376, Ann Arbor, Michigan 48106, attention: Investor Relations or by telephone
request to (734) 930-5555. These filings may also be obtained through the Investors section of
our website located at http://www.aastrom.com under the heading Financial Information. Except
for the documents explicitly incorporated by reference herein, the information available on or
through our website is not a part of this prospectus. Exhibits to such filings will not be
provided, unless such exhibits are specifically incorporated by reference into the information that
this prospectus incorporates.
Additionally, as discussed below under the heading Where You Can Find Additional
Information, the public may read and copy any materials we file with the SEC at the SECs Public
Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at
1.800.SEC.0330 for further information on the operation of the Public Reference Room. Such material
may also be obtained electronically by visiting the SECs web site on the Internet at
http://www.sec.gov.
You should rely only on the information incorporated by reference or provided in this
prospectus or any supplement. We have not authorized anyone else to provide you with different
information. You should not assume that information in this prospectus or any supplement is
accurate as of any date other than the date on the front of these documents.
MATERIAL CHANGES
There have been no material changes in our affairs that have occurred since the end of the
latest fiscal year for which audited financial statements were included in the latest Form 10-K and
that have not been described in a Form 10-Q or Form 8-K filed under the Exchange Act.
FORWARD-LOOKING STATEMENTS
This prospectus, including the documents that we incorporate by reference, contain
forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E
of the Securities Exchange Act. Any statements about our expectations, beliefs, plans, objectives,
assumptions or future events or performance are not historical facts and may be forward-looking.
These statements are often, but are not always, made through the use of terminology such as
anticipates, estimates, plans, projects, trends, opportunity, comfortable, current,
intention, position, assume, potential, outlook, remain, continue, maintain,
sustain, seek, achieve, continuing, ongoing, expects, believes, intend and similar
words or phrases, or future or conditional verbs such as will, would, should, could, may,
or similar expressions. Accordingly, these statements involve estimates, assumptions and
uncertainties which could cause actual results to differ materially from those expressed in them.
Any forward-looking statements are qualified in their entirety by reference to the factors
discussed throughout this report, and in particular those factors listed under the section Risk
Factors.
Because the factors referred to in the preceding paragraph could cause actual results or
outcomes to differ materially from those expressed in any forward-looking statements we make, you
should not place undue reliance on any such forward-looking statements. Further, any
forward-looking statement speaks only as of the date on which it is made, and we undertake no
obligation to update any forward-looking statement or statements to reflect events or circumstances
after the date on which such statement is made or to reflect
6
the occurrence of unanticipated events except as may be required by law. New factors emerge from
time to time, and it is not possible for us to predict which factors will arise. In addition, we
cannot assess the impact of each factor on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ materially from those contained in any
forward-looking statements. These forward-looking statements include statements regarding:
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potential strategic collaborations with others; |
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future capital needs and expected cash flows; |
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adequacy of existing capital to support operations for a specified time; |
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the rate and degree of progress on our product development and marketing plans; |
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the rate of regulatory approval to proceed with clinical trial programs and
the success achieved in clinical trials; |
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enrollment in and results of our clinical trials; |
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the requirements for marketing authorization from regulatory bodies in the
United States, the European Union and in other countries; |
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regulatory and manufacturing requirements and uncertainties; |
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our products and commercialization plans; and |
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revenue expectations and operating results. |
The information contained in this prospectus, as well as in our SEC filings, identifies
important factors that could adversely affect actual results and performance. Prospective investors
are urged to carefully consider such factors.
All forward-looking statements attributable to us are expressly qualified in their entirety by
the foregoing cautionary statements.
RISK FACTORS
Investors should carefully consider the risks and uncertainties and all other information
contained or incorporated by reference in this prospectus, including the risks and uncertainties
discussed under Risk Factors in our Annual Report on Form 10-K for the year ended June 30, 2009
and in our Quarterly Reports on Form 10-Q for the quarters ended September 30, 2009 and December
31, 2009. All of these Risk Factors are incorporated by reference herein in their entirety. These
risks and uncertainties are not the only ones facing us. Additional risks of which we are not
presently aware or that we currently believe are immaterial may also harm our business and results
of operations. The trading price of our common stock could decline due to the occurrence of any of
these risks, and investors could lose all or part of their investment. In assessing these risks,
investors should also refer to the other information contained or incorporated by reference in our
other filings with the SEC.
USE OF PROCEEDS
This prospectus relates to shares of our common stock that may be offered and sold from time
to time by the selling shareholder. We will receive no proceeds from the sale of shares of common
stock in this offering. However, we may receive up to $30.0 million in proceeds from the sale of
our common stock to Fusion Capital under the Purchase Agreement. Any proceeds from Fusion Capital
we receive under the Purchase Agreement are expected be used, together with other available funds,
to conduct operations and to continue to conduct our clinical development programs.
THE FUSION TRANSACTION
General
On June 12, 2009, we entered into a Common Stock Purchase Agreement with Fusion Capital Fund
II, LLC, an Illinois limited liability company. Under the Purchase Agreement, Fusion Capital is
obligated, under certain conditions, to purchase shares from us in an aggregate amount of $30.0
million from time to time over a 25-month period. Under the terms of the Purchase Agreement, Fusion
Capital received an initial commitment fee consisting of 181,529 shares of our common stock. Also,
we will issue to Fusion Capital an
7
additional 302,550 shares as a commitment fee pro rata as we receive the $30.0 million of future
funding. As of March 24, 2010, 1,900,083 shares of our common stock (including 232,962 shares
related to the commitment fee) were issued to Fusion Capital for net proceeds of $5.1 million. As
of March 24, 2010, there were 28,255,889 shares outstanding (28,196,584 shares held by
non-affiliates) excluding the 2,832,879 shares registered under this registration statement that
can be sold to Fusion and the 251,117 shares of additional commitment shares that Fusion Capital
has not yet received from us. If all of such shares offered hereby were issued and outstanding as
of the date hereof, the 4,984,079 shares (which includes the 1,900,083 shares already issued) would
represent 17.64% of the total common stock outstanding or 17.68% of the non-affiliate shares
outstanding as of the date hereof.
Under the Purchase Agreement and the Registration Rights Agreement we are required to register
and have included in the offering pursuant to this prospectus (1) 1,900,083 shares which have
already been issued (including 232,962 shares related to the commitment fee), (2) an additional
251,117 shares which we may issue in the future as a commitment fee pro rata as we receive the
future funding under the Purchase Agreement and (3) at least 2,832,879 shares which we may sell to
Fusion Capital (not including the additional commitment fee shares). All 4,984,079 shares are being
offered pursuant to this prospectus. Under the Purchase Agreement, we have the right but not the
obligation to sell more than the 4,500,000 shares to Fusion Capital. If we elect to sell more than
the 4,500,000 shares (which we have the right but not the obligation to do), we must first register
under the Securities Act any additional shares we may elect to sell to Fusion Capital before we can
sell such additional shares. The number of shares ultimately offered for sale by Fusion Capital is
dependent upon the number of shares purchased by Fusion Capital under the Purchase Agreement.
Generally, we have the right but not the obligation from time to time to sell our shares to
Fusion Capital in amounts between $100,000 and $4.0 million depending on certain conditions. We
have the right to control the timing and amount of any sales of our shares to Fusion Capital. The
purchase price of the shares will be determined based upon the market price of our shares without
any fixed discount at the time of each sale. Fusion Capital shall not have the right nor the
obligation to purchase any shares of our common stock on any business day that the price of our
common stock is below $0.80. If we elect to sell our shares of common stock to Fusion Capital at a
price per share below $2.88, we may be required to obtain shareholder approval in order to be in
compliance with the Nasdaq Capital Market rules.
There are no negative covenants, restrictions on future fundings, penalties or liquidated
damages in the Purchase Agreement or the Registration Rights Agreement. The Purchase Agreement may
be terminated by us at any time at our discretion without any cost to us. The Purchase Agreement
provides that neither party has the ability to amend the Purchase Agreement and the obligations of
both parties are non-transferable.
In January 2010, we completed an underwritten public offering of common stock and warrants.
Pursuant to the underwriting agreement with Oppenheimer & Co., Inc., we have agreed not to issue or
sell any securities under the Purchase Agreement with Fusion Capital for a period of 180 days from
January 15, 2010 without the prior written consent of Oppenheimer & Co. Inc.
Purchase of Shares under the Purchase Agreement
Under the Purchase Agreement, on any business day selected by us, we may direct Fusion Capital
to purchase up to $100,000 of our common stock. The purchase price per share is equal to the lesser
of:
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the lowest sale price of our common stock on the purchase date; or |
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the average of the three lowest closing sale prices of our common
stock during the 12 consecutive business days prior to the date
of a purchase by Fusion Capital. |
The purchase price will be equitably adjusted for any reorganization, recapitalization,
non-cash dividend, stock split, or other similar transaction occurring during the business days
used to compute the purchase price. We may direct Fusion Capital to make multiple purchases from
time to time in our sole discretion; no sooner then every other business day.
Our Right to Increase the Amount to be Purchased
In addition to purchases of up to $100,000 from time to time, we may also from time to time
elect on any single business day selected by us to require Fusion Capital to purchase our shares in
an amount up to $100,000 provided that our closing share price is not below $2.00 on the purchase
date. We may also require Fusion Capital to purchase our shares in an amount up to $250,000 if our
closing share price is not below $3.60 on the purchase date. In addition, we can require Fusion
Capital to purchase our shares in an amount up to $500,000 if our closing share price is not below
$6.00 on the purchase date. Furthermore, we can require Fusion Capital to purchase our shares in an
amount up to $1.0 million if our closing share price is not below $10.00 on the purchase date.
Moreover, we can require Fusion Capital to purchase our shares in an amount up to $2.0 million if
our closing share price is not below $16.00 on the purchase date. Finally, we may also require
Fusion Capital to purchase our shares in amount up to $4.0 million if our closing share price is
not below $32.00 on the purchase date. We may direct Fusion Capital to make multiple large
purchases from time to time in our sole discretion; however, at least 1 business day must have
passed since the most recent large purchase was completed. The price
8
at which our common stock would be purchased in this type of larger purchase will be the lesser of
(i) the lowest sale price of our common stock on the purchase date and (ii) the lowest purchase
price (as described above) during the previous 10 business days prior to the purchase date.
Minimum Purchase Price
Under the Purchase Agreement, we have set a minimum purchase price (floor price) of $0.80.
However, Fusion Capital shall not have the right nor the obligation to purchase any shares of our
common stock in the event that the purchase price would be less the floor price. Specifically,
Fusion Capital shall not have the right or the obligation to purchase shares of our common stock on
any business day that the market price of our common stock is below $0.80.
Compliance with Nasdaq Market Rules
In order to be in compliance with Nasdaq Capital Market rules, we cannot be required to sell,
and Fusion Capital shall not have the right or the obligation to purchase, shares of our common
stock at a price below $2.88, which represents the greater of the book value per share of our
common stock as of March 31, 2009 or the closing price per share of our common stock on June 11,
2009, the business day before we entered into the Purchase Agreement, plus $0.01. If we elect to
sell our shares to Fusion Capital at a price per share below $2.88, we may be required to obtain
shareholder approval in order to be in compliance with the Nasdaq Capital Market rules.
Events of Default
Generally, Fusion Capital may terminate the Purchase Agreement without any liability or
payment to the Company upon the occurrence of any of the following events of default:
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the effectiveness of the registration statement of which this prospectus is a part of lapses for any
reason (including, without limitation, the issuance of a stop order) or is unavailable to Fusion Capital
for sale of our common stock offered hereby and such lapse or unavailability continues for a period of 10
consecutive business days or for more than an aggregate of 30 business days in any 365-day period; |
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suspension by our principal market of our common stock from trading for a period of 3 consecutive
business days; |
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the de-listing of our common stock from our principal market provided our common stock is not immediately
thereafter trading on the OTC Bulletin Board Market, the Nasdaq Global Market, the NYSE Amex, or the New
York Stock Exchange; |
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the transfer agents failure for 5 business days to issue to Fusion Capital shares of our common stock
which Fusion Capital is entitled to under the Purchase Agreement; |
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any material breach of the representations or warranties or covenants contained in the Purchase Agreement
or any related agreements which has or which could have a material adverse effect on us subject to a cure
period of 5 business days; or |
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any participation or threatened participation in insolvency or bankruptcy proceedings by or against us; or |
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a material adverse change in our business. |
Our Termination Rights
We have the unconditional right at any time for any reason to give notice to Fusion Capital
terminating the Purchase Agreement without any cost to us.
No Short-Selling or Hedging by Fusion Capital
Fusion Capital has agreed that neither it nor any of its affiliates shall engage in any direct
or indirect short-selling or hedging of our common stock during any time prior to the termination
of the Purchase Agreement.
Effect of Performance of the Purchase Agreement on Our Shareholders
All 4,984,079 shares registered in this offering are expected to be freely tradable. It is
anticipated that shares registered in this offering will be sold over a period of up to 25 months
from the date of the original effective date of this registration statement on June
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29, 2009. The sale by Fusion Capital of a significant amount of shares registered in this offering
at any given time could cause the market price of our common stock to decline and to be highly
volatile. Fusion Capital may ultimately purchase or be issued all, some or none of the 3,083,966
shares of common stock not yet issued but registered in this offering. As of March 24, 2010, we
have issued 1,900,083 shares of our common stock to Fusion Capital (including 232,962 shares
related to the commitment fee). Fusion Capital may sell all, some or none of the shares it
acquires in this offering. Therefore, sales to Fusion Capital by us under the Purchase Agreement
may result in substantial dilution to the interests of other holders of our common stock. However,
we have the right to control the timing and amount of any sales of our shares to Fusion Capital and
the Purchase Agreement may be terminated by us at any time at our discretion without any cost to
us.
In connection with entering into the Purchase Agreement, we authorized the sale to Fusion
Capital of up to 4,500,000 shares of our common stock (not including the 484,079 shares that will
or may be issued related to the commitment fee) (22.47% of our outstanding common stock on June 12,
2009, the date of the Purchase Agreement, and 15.93% of our outstanding common stock on March 24,
2010). We have the right to terminate the Purchase Agreement without any payment or liability to
Fusion Capital at any time. Subject to approval by our board of directors, we have the right but
not the obligation to sell more than 4,500,000 shares offered hereby, however, we will be required
to file a new registration statement and have it declared effective by the U.S. Securities &
Exchange Commission. The number of shares ultimately offered for sale by Fusion Capital under this
prospectus is dependent upon the number of shares purchased by Fusion Capital under the Purchase
Agreement. As of March 24, 2010, 1,900,083 shares of our common stock (including 232,962 shares
related to the commitment fee) were issued to Fusion Capital for net proceeds of $5.1 million. The
following table sets forth the amount of proceeds we would receive from Fusion Capital from the
sale of shares at varying purchase prices:
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Percentage of Outstanding |
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Proceeds from the Sale of |
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Shares After Giving Effect to |
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Shares to Fusion Capital Under |
Assumed Average |
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Number of Shares |
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the Purchased Shares Issued to Fusion |
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the Common Stock Purchase |
Purchase Price(1) |
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to be Sold if Full Purchase(2) |
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Capital(3) |
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Agreement(2) |
$2.00 |
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4,500,000 |
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13.70 |
% |
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$ |
9,000,000 |
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$2.80 |
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4,500,000 |
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13.68 |
% |
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$ |
12,600,000 |
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$3.20 |
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4,500,000 |
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13.68 |
% |
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$ |
14,400,000 |
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$4.00 |
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4,500,000 |
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13.66 |
% |
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$ |
18,000,000 |
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$5.28 |
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4,500,000 |
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13.64 |
% |
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$ |
23,760,000 |
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$6.00 |
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4,500,000 |
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13.62 |
% |
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$ |
27,000,000 |
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$6.67 |
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4,500,000 |
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13.61 |
% |
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$ |
30,000,000 |
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(1) |
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In order to be in compliance with Nasdaq Capital Market rules, we
cannot be required to sell, and Fusion Capital shall not have the
right or the obligation to purchase, shares of our common stock
at a price below $2.88 if such issuance would breach our
obligations under the Nasdaq Capital Market rules. |
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As of March 24, 2010, 1,667,121 shares of the 4,500,000 shares
available for purchase pursuant to the Purchase Agreement have
been purchased by Fusion Capital for net proceeds of $5.1
million. An additional 2,832,879 of additional shares may be sold
to Fusion Capital pursuant to the Purchase Agreement (not
including the additional commitment fee shares). |
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(3) |
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The denominator is based on 28,255,889 shares outstanding as of
March 24, 2010, which includes the 1,900,083 shares previously
issued to Fusion Capital (including 232,962 shares for the
commitment fee ). The denominator also includes the shares of common stock not
yet issued and the corresponding additional pro rata commitment shares. The numerator is
based on the number of shares issuable under the Purchase
Agreement at the corresponding assumed purchase price set forth
in the adjacent column. The changes in percentages relate solely to the number of additional
commitment shares to be issued pro rata
based on the amount of funding. |
10
THE SELLING SHAREHOLDER
The following table presents information regarding the selling shareholder. Neither the
selling shareholder nor any of its affiliates has held a position or office, or had any other
material relationship, with us. However, in October 2008, we entered into a common stock purchase
agreement with Fusion Capital, pursuant to which we sold an aggregate of 2,836,583 shares for total
gross proceeds of $8,628,561. The agreement was terminated on May 27, 2009. The selling
shareholder may elect to sell none, some or all of the shares offered under this prospectus and we
cannot estimate the number of shares of common stock that the selling shareholder will beneficially
own after termination of the sales under this prospectus. For purposes of the table below, we have
assumed that, after completion of the offering, none of the shares covered by this prospectus will
be held by the selling shareholder.
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Percentage of |
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Shares |
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Beneficially |
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Shares Beneficially |
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Maximum Number of |
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Shares Beneficially |
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Owned after |
Selling Shareholder |
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Owned before Offering |
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Shares Offered |
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Owned after Offering |
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Offering(1) |
Fusion Capital Fund II, LLC (2) |
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564,508 |
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4,984,079 |
(3) |
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382,978 |
(3) |
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1.2 |
% |
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(1) |
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Applicable percentage of ownership is based on
28,255,889 shares of our common stock outstanding as of
March 24, 2010, together with securities exercisable or
convertible into shares of common stock within 60 days
of March 24, 2010 for the selling shareholder and
includes the 3,083,996 shares which are not presently
issued. Beneficial ownership is determined in
accordance with the rules of the SEC and generally
includes voting or investment power with respect to
securities. Shares of common stock are deemed to be
beneficially owned by the person holding such
securities for the purpose of computing the percentage
of ownership of such person, but are not treated as
outstanding for the purpose of computing the percentage
ownership of any other person. |
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(2) |
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Steven G. Martin and Joshua B. Scheinfeld, the
principals of Fusion Capital, are deemed to be
beneficial owners of all of the shares of common stock
owned by Fusion Capital. Messrs. Martin and Scheinfeld
have shared voting and disposition power over the
shares being offered under this prospectus. |
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(3) |
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We are electing to register hereby 4,984,079 shares in
the aggregate, 2,832,879 shares which are not presently
issued and which we may sell or issue to Fusion Capital
at our discretion, 1,667,121 shares that we have issued
to Fusion Capital for net proceeds of $5.1 million,
232,962 shares that we have issued to Fusion Capital as
a commitment fee and 251,117 shares we may issue to
Fusion Capital as an additional commitment fee pro rata
as we receive the $30 million. Therefore, we may issue
to Fusion Capital up to an additional 3,083,996 shares
under the Purchase Agreement but Fusion Capital does
not presently beneficially own those shares as
determined in accordance with the rules of the SEC.
Fusion has informed us that prior to entering into the
Purchase Agreement Fusion Capital owned 382,978 of our
shares that it previously acquired. |
11
PLAN OF DISTRIBUTION
The common stock offered by this prospectus is being offered by Fusion Capital Fund II, LLC,
or Fusion Capital, the selling shareholder. The common stock may be sold or distributed from time
to time by the selling shareholder directly to one or more purchasers or through brokers, dealers,
or underwriters who may act solely as agents at market prices prevailing at the time of sale, at
prices related to the prevailing market prices, at negotiated prices, or at fixed prices, which may
be changed. The sale of the common stock offered by this prospectus may be effected in one or more
of the following methods:
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ordinary brokers transactions; |
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transactions involving cross or block trades; |
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through brokers, dealers, or underwriters who may act solely as agents |
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at the market into an existing market for the common stock; |
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in other ways not involving market makers or established business
markets, including direct sales to purchasers or sales effected
through agents; |
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in privately negotiated transactions; |
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any combination of the foregoing; or |
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in such other transactions as may be permitted by law. |
In order to comply with the securities laws of certain states, if applicable, the shares may
be sold only through registered or licensed brokers or dealers. In addition, in certain states, the
shares may not be sold unless they have been registered or qualified for sale in the state or an
exemption from the registration or qualification requirement is available and complied with.
Brokers, dealers, underwriters, or agents participating in the distribution of the shares as
agents may receive compensation in the form of commissions, discounts, or concessions from the
selling shareholder and/or purchasers of the common stock for whom the broker-dealers may act as
agent. The compensation paid to a particular broker-dealer may be less than or in excess of
customary commissions.
Fusion Capital is an underwriter within the meaning of the Securities Act.
Neither we nor Fusion Capital can presently estimate the amount of compensation that any agent
will receive. We know of no existing arrangements between or among Fusion Capital and any other
shareholder, broker, dealer, underwriter, or agent relating to the sale or distribution of the
shares offered by this prospectus. At the time a particular offer of shares is made, a prospectus
supplement, if required, will be distributed that will set forth the names of any agents,
underwriters, or dealers and any compensation from the selling shareholder, and any other required
information.
We will pay all of the expenses incident to the registration, offering, and sale of the shares
to the public other than commissions or discounts of underwriters, broker-dealers, or agents. We
have also agreed to indemnify Fusion Capital and related persons against specified liabilities,
including liabilities under the Securities Act.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to our directors, officers, and controlling persons, we have been advised that in the opinion of
the SEC this indemnification is against public policy as expressed in the Securities Act and is
therefore, unenforceable.
Fusion Capital and its affiliates have agreed not to engage in any direct or indirect short
selling or hedging of our common stock during the term of the Purchase Agreement.
We have advised Fusion Capital that while it is engaged in a distribution of the shares
included in this prospectus it is required to comply with Regulation M promulgated under the
Securities Exchange Act of 1934, as amended. With certain exceptions, Regulation M precludes the
selling shareholder, any affiliated purchasers, and any broker-dealer or other person who
participates in the distribution from bidding for or purchasing, or attempting to induce any person
to bid for or purchase any security which is the subject of the distribution until the entire
distribution is complete. Regulation M also prohibits any bids or purchases made in order to
stabilize the price of a security in connection with the distribution of that security. All of the
foregoing may affect the marketability of the shares offered hereby this prospectus.
This offering will terminate on the date that all shares offered by this prospectus have been
sold by Fusion Capital.
12
DESCRIPTION OF SECURITIES TO BE REGISTERED
The following description of our common stock and certain provisions of our restated articles
of incorporation, as amended, or our charter, and bylaws is a summary and is qualified in its
entirety by the provisions of our charter and bylaws.
Our authorized capital stock consists of 62,500,000 shares of common stock, no par value per
share, and 5,000,000 shares of preferred stock, no par value per share.
Common Stock
Holders of our common stock are entitled to one vote for each share held of record on all
matters submitted to a vote of shareholders and do not have cumulative voting rights. Holders of
common stock have no preemptive, redemption or conversion rights and are not subject to future
calls or assessments. No sinking fund provisions apply to our common stock. All outstanding shares
are fully-paid and non-assessable. In the event of our liquidation, dissolution or winding up,
holders of common stock are entitled to share ratably in assets available for distribution, subject
to prior distribution rights of any preferred stock then outstanding. Holders of common stock are
entitled to receive proportionately any such dividends declared by the board of directors, out of
legally available funds for dividends, subject to any preferences that may be applicable to any
shares of preferred stock that may be outstanding at that time. The rights, preferences and
privileges of holders of common stock are set forth in our charter, which may be amended by the
holders of a majority of the outstanding shares of common stock.
Michigan Law and Certain Charter and By-Law Provisions
We are subject to certain anti-takeover provisions of the Michigan Business Corporation Act
(the MBCA) that could delay or make more difficult a merger or tender offer involving Aastrom.
Chapter 7A of the MBCA prevents, in general, an interested shareholder (defined generally as a
person owning 10% or more of a corporations outstanding voting shares) from engaging in a
business combination (as defined therein) with a Michigan corporation unless: (a) the board of
directors issues an advisory statement, holders of 90% of the shares of each class of stock
entitled to vote approve the transaction, and holders of two-thirds of the disinterested shares
of each class of stock approve the transaction; or (b) the interested shareholder has been an
interested shareholder for at least five years and has not acquired beneficial ownership of any
additional shares of the corporation subsequent to the transaction which resulted in such
shareholder being classified as an interested shareholder, and meets certain requirements,
including provisions relating to the fairness of the price and the form of consideration paid; or
(c) the board of directors, by resolution, exempts a particular interested shareholder from these
provisions prior to the interested shareholder becoming an interested shareholder. The MBCA also
contains certain other provisions that could have anti-takeover effects.
Our charter does not provide shareholders with the right to act without a meeting and does not
provide for cumulative voting in the election of directors. The amendment of any of these
provisions would require approval by holders of at least a majority of the shares of our
outstanding common stock.
These and other provisions of our charter could have the effect of deterring certain takeovers
or delaying or preventing certain changes in control or management of Aastrom, including
transactions in which shareholders might otherwise receive a premium for their shares over
then-current market prices.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Continental Stock Transfer & Trust
Company.
MARKET PRICE OF COMMON EQUITY
Our common stock is traded on the Nasdaq Capital Market under the symbol ASTM. The following
table sets forth the high and low sales prices for our common stock as reported on the Nasdaq
Capital Market for the periods indicated, as adjusted to the nearest cent.
|
|
|
|
|
|
|
|
|
|
|
High |
|
Low |
Year Ended June 30, 2010: |
|
|
|
|
|
|
|
|
Third quarter (through March 24, 2010) |
|
$ |
2.80 |
|
|
$ |
1.40 |
|
Second quarter |
|
$ |
3.60 |
|
|
$ |
1.92 |
|
First quarter |
|
$ |
4.72 |
|
|
$ |
2.80 |
|
13
SELECTED FINANCIAL DATA
The statement of operations data for the years ended June 30, 2007, 2008 and 2009 and for
the period from March 24, 1989 (Inception) to June 30, 2009 and the balance sheet data at June 30,
2008 and 2009, are derived from, and are qualified by reference to, the audited consolidated
financial statements incorporated by reference in this prospectus and should be read in conjunction
with those financial statements and notes thereto. The statement of operations data for the years
ended June 30, 2005 and 2006, and the balance sheet data at June 30, 2005, 2006 and 2007, are
derived from audited consolidated financial statements not included or incorporated by reference
herein. The unaudited statement of operations data for the six-month periods ended December 31,
2009 and 2008 and for the period from March 24, 1989 (Inception) to December 31, 2009 and the
unaudited balance sheet data at December 31, 2009 and 2008, are derived from, and are qualified by
reference to, the unaudited consolidated financial statements incorporated by reference in this
prospectus and should be read in conjunction with those financial statements and notes thereto.
The data set forth below are qualified by reference to, and should be read in conjunction
with, the consolidated financial statements and notes thereto and Managements Discussion and
Analysis of Financial Condition and Results of Operations set forth in our Annual Report on Form
10-K for the fiscal period ended June 30, 2009 and in our Quarterly Reports on Form 10-Q for the
fiscal periods ended September 30, 2009 and December 31, 2009.
On February 18, 2010, we effected a one-for-eight reverse stock split of our common stock.
Presented below is selected financial data, as if the reverse stock split was effective at these
dates (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 24, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Inception) |
|
|
|
Year ended June 30, |
|
|
to June 30, |
|
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2008 |
|
|
2009 |
|
|
2009 |
|
Statement of Operations Data
(in thousands, except per share
amounts): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
909 |
|
|
$ |
863 |
|
|
$ |
685 |
|
|
$ |
522 |
|
|
$ |
182 |
|
|
$ |
13,523 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(12,417 |
) |
|
|
(17,733 |
) |
|
|
(19,469 |
) |
|
|
(21,219 |
) |
|
|
(16,169 |
) |
|
|
(206,244 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss (1) |
|
|
(11,811 |
) |
|
|
(16,475 |
) |
|
|
(17,594 |
) |
|
|
(20,133 |
) |
|
|
(15,946 |
) |
|
|
(194,855 |
) |
Net loss per common share (basic and
diluted) |
|
$ |
(1.01 |
) |
|
$ |
(1.24 |
) |
|
$ |
(1.18 |
) |
|
$ |
(1.24 |
) |
|
$ |
(0.89 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
2006 |
|
2007 |
|
2008 |
|
2009 |
|
Balance Sheet Data (in thousands): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
33,897 |
|
|
$ |
44,881 |
|
|
$ |
32,848 |
|
|
$ |
26,217 |
|
|
$ |
19,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt |
|
|
|
|
|
|
|
|
|
|
1,536 |
|
|
|
1,229 |
|
|
|
784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
33,028 |
|
|
|
42,342 |
|
|
|
28,251 |
|
|
|
23,334 |
|
|
|
17,284 |
|
|
|
|
(1) |
|
Net loss for fiscal years ended June 30, 2006, 2007, 2008 and 2009 included stock-based
compensation expense under Financial Accounting Standards Board Statement No. 123(R),
Share-Based Payment, (SFAS 123(R)) of $1.0, $2.8, $1.6 and $1.4 million, respectively,
related to employee and director stock-based awards. For the year ended June 30, 2005, we
accounted for stock-based awards to employees and directors in accordance with Accounting
Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25) and its
related interpretations, accordingly, we recognized no compensation expense for stock-based
awards because the awards had time-based vesting and the exercise price equaled the fair
market value of the underlying common stock on the date of grant. See Note 3 to our
consolidated financial statements. |
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 24, 1989 |
|
|
|
Six Months Ended |
|
|
Six Months Ended |
|
|
(Inception)to |
|
|
|
December 31, 2008 |
|
|
December 31, 2009 |
|
|
December 31, 2009 |
|
|
|
Unaudited) |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Statement of Operations Data
(in thousands, except per share
amounts): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
55 |
|
|
$ |
89 |
|
|
$ |
13,612 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(8,171 |
) |
|
|
(8,401 |
) |
|
|
(214,645 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(8,016 |
) |
|
|
(8,376 |
) |
|
|
(203,231 |
) |
Net loss per common share (basic and
diluted) |
|
$ |
(0.48 |
) |
|
$ |
(0.40 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
|
December 31, 2009 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Balance Sheet Data (in thousands): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
19,600 |
|
|
$ |
16,624 |
|
|
|
|
|
|
|
|
|
|
Long-term debt |
|
|
1,011 |
|
|
|
548 |
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
17,116 |
|
|
|
14,358 |
|
LEGAL MATTERS
The validity of the common stock offered by this prospectus will be passed upon for us by
Dykema Gossett PLLC, Ann Arbor, Michigan, acting as special counsel to the Company.
EXPERTS
The financial statements and managements assessment of the effectiveness of internal control
over financial reporting (which is included in Managements Report on Internal Control over
Financial Reporting) incorporated in this prospectus by reference to the Annual Report on Form 10-K
for the year ended June 30, 2009 have been so incorporated in reliance on the report of
PricewaterhouseCoopers LLP, an independent registered public accounting firm, given on the
authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus constitutes the prospectus we filed as a part of the registration statement
and it does not contain all information in the registration statement and the included exhibits,
financial statements and schedules. You are referred to the registration statement, the included
exhibits, financial statements and schedules for further information. This information is
qualified in its entirety by such other information.
In addition, we are subject to the informational requirements of the Securities Exchange Act
of 1934, as amended, and, in accordance with such requirements, we file reports, proxy statements
and other information with the SEC relating to our business, financial statements and other
matters.
Reports and proxy and information statements filed under or pursuant to Sections 13(a), 14 and
15(d) of the Securities Exchange Act of 1934 and other information filed with the SEC as well as
copies of the registration statement can be inspected and copied at the Public Reference Room
maintained by the SEC at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at
1.800.SEC.0330 for further information on the operation of the Public Reference Room. Such material
may also be obtained electronically by visiting the SECs web site on the Internet at
http://www.sec.gov. Our common stock is traded on the Nasdaq Capital Market under the symbol
ASTM.
15
Copies of our filings with the Securities and Exchange Commission are also available, free of
charge, in the Investors section of our website located at http://www.aastrom.com under the
heading Financial Information. Except for those documents explicitly incorporated by reference
herein, the information available on or through our website is not a part of this prospectus.
You should rely only on the information contained in this prospectus or the documents
incorporated by reference. Neither we nor the selling shareholder has authorized anyone to provide
you with any information that is different from that contained in this prospectus. The information
contained in this prospectus is accurate as of the date of this prospectus. You should not assume
that there have been no changes in the affairs of the Company since the date of this prospectus or
that the information in this prospectus is correct as of any time after the date of this
prospectus, regardless of the time that this prospectus is delivered or any sale of the common
stock offered by this prospectus is made. This prospectus is not an offer to sell or a solicitation
of an offer to buy the shares covered by this prospectus in any jurisdiction where the offer or
solicitation is unlawful.
16
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
As permitted by the Michigan Business Corporation Act, our Bylaws contain provisions that
permit us to indemnify our directors and officers to the full extent permitted by Michigan law and
our Restated Articles of Incorporation, as amended, contain provisions that eliminate the personal
liability of our directors in each case for monetary damages to us or our shareholders for breach
of their fiduciary duties, except to the extent that Michigan law prohibits indemnification or
elimination of liability. These provisions do not limit or eliminate our rights or the rights of
any shareholder to seek an injunction or any other non-monetary relief in the event of a breach of
a directors or officers fiduciary duty. In addition, these provisions apply only to claims
against a director or officer arising out of his or her role as a director or officer and do not
relieve a director or officer from liability if he or she engaged in willful misconduct or a
knowing violation of the criminal law or any federal or state securities law.
The rights of indemnification provided in our Bylaws are not exclusive of any other rights
that may be available under any insurance or other agreement, by vote of shareholders or
disinterested directors or otherwise.
Insofar as indemnification for liabilities arising under the Securities Act of 1933, as
amended (the Securities Act), may be permitted to directors, officers or persons controlling us
pursuant to the foregoing provisions, we have been informed that in the opinion of the Securities
and Exchange Commission this type of indemnification is against public policy as expressed in the
Securities Act and is therefore unenforceable.
* * *
No dealer, salesperson, or other person has been authorized to give any information or to make
any representation not contained in this prospectus, and, if given or made, such information and
representation should not be relied upon as having been authorized by Aastrom Biosciences, Inc. or
the selling shareholder. This prospectus does not constitute an offer to sell or a solicitation of
an offer to buy any of the securities offered by this prospectus in any jurisdiction or to any
person to whom it is unlawful to make such offer or solicitation. Neither the delivery of this
prospectus nor any sale made hereunder shall under any circumstances create an implication that
there has been no change in the facts set forth in this prospectus or in the affairs of Aastrom
Biosciences, Inc. since the date hereof.
17
4,984,079 SHARES
Aastrom
AASTROM BIOSCIENCES, INC.
COMMON STOCK
PROSPECTUS
, 2010
Part IIINFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
The expenses payable by Aastrom Biosciences. Inc. (the Registrant, Aastrom or the
Company) in connection with the issuance and distribution of the securities being registered
(other than underwriting discounts and commissions, if any) are set forth below. Each item listed
is estimated, except for the Securities and Exchange Commission registration fee and the Nasdaq
Stock Market additional listing fee.
|
|
|
|
|
Securities and Exchange Commission registration fee |
|
$ |
790 |
|
Nasdaq Stock Market additional listing fees |
|
|
26,500 |
|
Accounting fees and expenses |
|
|
27,000 |
|
Legal fees and expenses |
|
|
67,500 |
|
Registrar and transfer agents fees and expenses |
|
|
5,000 |
|
Printing and engraving expenses |
|
|
2,500 |
|
Miscellaneous |
|
|
2,210 |
|
|
|
|
|
Total expenses |
|
|
131,500 |
|
|
|
|
|
|
|
|
Item 14. Indemnification of Directors and Officers |
Sections 1561 through 1571 of the Michigan Business Corporation Act (the MBCA) authorize a
corporation to grant or a court to award, indemnity to directors, officers, employees and agents in
terms sufficiently broad to permit such indemnification under certain circumstances for liabilities
(including reimbursement for expenses incurred) arising under the Securities Act of 1933.
The Bylaws of the Company provide that the Company shall, to the fullest extent authorized or
permitted by the MBCA, or other applicable law, indemnify a director or officer who was or is a
party or is threatened to be made a party to any proceeding by or in the right of the Company to
procure a judgment in its favor by reason of the fact that such person is or was a director,
officer, employee or agent of the Company, against expenses, including actual and reasonable
attorneys fees, and amounts paid in settlement incurred in connection with the action or suit, if
the indemnitee acted in good faith and in a manner the person reasonably believed to be in, or not
opposed to, the best interests of the Company or its shareholders. This section also authorizes the
Company to advance expenses incurred by any agent of the Company in defending any proceeding prior
to the final disposition of such proceeding upon receipt of an undertaking by or on behalf of the
agent to repay such amount unless it shall be determined ultimately that the agent is entitled to
be indemnified.
The Bylaws also authorize the Company to purchase and maintain insurance on behalf of any
person who is or was a director, officer, employee or agent of the Company against any liability
asserted against or incurred by such person in such capacity or arising out of such persons status
as such, regardless of whether the Company would have the power to indemnify such person against
such liability under the provisions of the MBCA.
The Company has entered into indemnification agreements with certain individuals which contain
provisions that may in some respects be broader than the specific indemnification provisions
contained under applicable law. The indemnification agreement may require the Company, among other
things, to indemnify such directors, officers and key personnel against certain liabilities that
may arise by reason of their status or service as directors, officers or employees of the Company,
to advance the expenses incurred by such parties as a result of any threatened claims or
proceedings brought against them as to which they could be indemnified, and to the maximum extent
that insurance coverage of such directors, officers and key employees under the Companys
directors and officers liability insurance policies is maintained.
Section 1209 of the MBCA permits a Michigan corporation to include in its Articles of
Incorporation a provision eliminating or limiting a directors liability to a corporation or its
shareholders for monetary damages for breaches of fiduciary duty. The enabling statute provides,
however, that liability for breaches of the duty of loyalty, acts or omissions not in good faith or
involving intentional misconduct or knowing violations of the law, or the receipt of improper
personal benefits cannot be eliminated or limited in this manner. The Companys Restated Articles
of Incorporation include a provision which eliminates, to the fullest extent permitted by the MBCA,
director liability for monetary damages for breaches of fiduciary duty.
II-1
Item 15. Recent Sales of Unregistered Securities
On October 28, 2008, the Company issued to Fusion Capital 242,039 shares of common stock as
the initial commitment shares in consideration of the equity financing of up to $15.0 million which
was being provided to the Company by Fusion Capital.
On June 12, 2009, the Company issued to Fusion Capital 181,529 shares of common stock as the
initial commitment shares for a new equity financing of up to $30.0 million, which was being
provided to the company by Fusion Capital. All of these securities were issued by the Company
without registration in reliance upon an exemption under Section 4(2) of the Securities Act because
the offer and sale was made in a privately negotiated transaction. The share certificate issued to
Fusion Capital has been appropriately legended. The Company ascertained that Fusion Capital is an
accredited investor and otherwise took steps to assure compliance with private placement
requirements.
During the fiscal quarter and six months ended December 31, 2009, an additional 274,619 and
1,718,554 shares of the Companys common stock, respectively, including 8,067 and 51,433 shares
issued as payment of the Companys commitment fee, respectively, were issued to Fusion Capital for
net proceeds of $800,000 and $5,100,000, respectively.
Item 16. Exhibits
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
3.1 |
|
|
Restated Articles of Incorporation of Aastrom, filed as Exhibit 4.1 to Aastroms Current Report
on Form 8-K filed on December 17, 2009 and incorporated herein by reference. |
|
|
|
|
|
|
3.2* |
|
|
Certificate of Amendment to Restated Articles of Incorporation of Aastrom dated February 9, 2010. |
|
|
|
|
|
|
3.3 |
|
|
Bylaws of Aastrom, as amended, filed as Exhibit 3.2 to Aastroms Current Report on Form 8-K
filed on October 23, 2008 and incorporated herein by reference. |
|
|
|
|
|
|
5.1+ |
|
|
Opinion of Dykema Gossett PLLC. |
|
|
|
|
|
|
10.1 |
|
|
Form of Indemnification Agreement, attached as Exhibit 10.1 to Aastroms Registration Statement
on Form S-1 (No. 333-15415), filed on November 1, 1996 and incorporated herein by reference. |
|
|
|
|
|
|
10.2 |
|
|
Amended and Restated 1992 Incentive and Non-Qualified Stock Option Plan and forms of agreements
thereunder, attached as Exhibit 10.5 to Aastroms Registration Statement on Form S-1 (No.
333-15415), filed on November 1, 1996, incorporated herein by reference. |
|
|
|
|
|
|
10.3 |
|
|
Form of Employment Agreement, attached as Exhibit 10.8 to Aastroms Registration Statement on
Form S-1 (No. 333-15415), filed on November 1, 1996, incorporated herein by reference. |
|
|
|
|
|
|
10.4 |
|
|
License Agreement, dated July 17, 1992, between J.G. Cremonese and Aastrom and related addenda
thereto dated July 14, 1992 and July 7, 1993, attached as Exhibit 10.11 to Aastroms
Registration Statement on Form S-1 (No. 333-15415), filed on November 1, 1996, incorporated
herein by reference. |
|
|
|
|
|
|
10.5 |
|
|
License Agreement, dated March 13, 1992, between Aastrom and the University of Michigan and
amendments thereto dated March 13, 1992, October 8, 1993 and June 21, 1995, attached as Exhibit
10.17 to Aastroms Registration Statement on Form S-1 (No. 333-15415), filed on November 1,
1996, incorporated herein by reference. |
II-2
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
10.6 |
|
|
Aastrom Biosciences 2001 Stock Option Plan, attached as
Exhibit 10.72 to Aastroms Annual Report on Form 10-K for the
year ended June 30, 2002, incorporated herein by reference. |
|
|
|
|
|
|
10.7 |
|
|
Master Supply Agreement with Astro Instrumentation, LLC,
attached as Exhibit 10.76 to Aastroms Annual Report on Form
10-K for the year ended June 30, 2003, incorporated herein by
reference. |
|
|
|
|
|
|
10.8 |
|
|
Supply Agreement between Aastrom and Moll Industries, Inc.,
dated December 16, 2003, attached as Exhibit 10.77 to
Aastroms Annual Report on Form 10-K for the year ended June
30, 2004, incorporated herein by reference. |
|
|
|
|
|
|
10.9 |
|
|
2004 Equity Incentive Plan, attached as Exhibit 10.82 to
Amendment No. 1 to Aastroms Quarterly Report on Form 10-Q/A
for the quarter ended September 30, 2004, incorporated herein
by reference. |
|
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10.10 |
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Form of Option and Restricted Stock Award Agreements for
Grants under 2004 Equity Incentive Plan, attached as Exhibit
10.84 to Aastroms Annual Report on Form 10-K for the year
ended June 30, 2005, incorporated herein by reference. |
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10.11 |
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Employee Compensation Guidelines, attached as Exhibit 10.85 to
Aastroms Annual Report on Form 10-K for the year ended June
20, 2005, incorporated herein by reference. |
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10.12 |
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Amendment dated December 5, 2002 to License Agreement with the
University of Michigan, attached as Exhibit 10.87 to Aastroms
Annual Report on Form 10-K for the year ended June 30, 2005,
incorporated herein by reference. |
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10.13 |
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Employment Agreement with George W. Dunbar dated July 17,
2006, attached as Exhibit 99.1 to Aastroms Current Report on
Form 8-K filed on July 18, 2006, incorporated herein by
reference. |
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10.14 |
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Summary of Changes to Employee Compensation Guidelines,
attached as Exhibit 10.94 to Aastroms Quarterly Report on
Form 10-Q for the quarter ended December 31, 2006,
incorporated herein by reference. |
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10.15 |
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2004 Equity Incentive Plan, as amended, attached as Exhibit
99.1 to Aastroms Current Report on Form 8-K filed on November
8, 2006, incorporated herein by reference. |
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10.16 |
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Forms of Grant Notice and Stock Option Agreement for Grants
under 2004 Equity Incentive Plan, as amended, attached as
Exhibit 99.2 to Aastroms Current Report on Form 8-K filed on
November 8, 2006, incorporated herein by reference. |
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10.17 |
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Placement Agency Agreement, dated October 15, 2007, by and
between the Company and BMO Capital Markets Corp., attached as
Exhibit 10.1 to Aastroms Current Report on Form 8-K filed on
October 16, 2007, incorporated herein by reference. |
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10.18 |
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Escrow Agreement, dated as of October 15, 2007, among the
Company, BMO Capital Markets Corp. and The Bank of New York,
attached as Exhibit 10.2 to Aastroms Current Report on Form
8-K filed on October 16, 2007, incorporated herein by
reference. |
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10.19 |
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Form of Purchase Agreement, attached as Exhibit 10.3 to
Aastroms Current Report on Form 8-K filed on October 16,
2007, incorporated herein by reference. |
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10.20 |
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Form of Warrant, attached as Exhibit 10.2 to Aastroms Current
Report on Form 8-K filed on October 16, 2007, incorporated
herein by reference. |
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10.21 |
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Standard Lease between Aastrom and Dominos Farms Office Park,
L.L.C. dated January 31, 2007, attached as Exhibit 10.96 to
Amendment No. 2 to Aastroms Annual Report on Form 10-K for
the year ended June 30, 2007, incorporated herein by
reference. |
II-3
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Exhibit No. |
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Description |
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10.22 |
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Nonemployee Director Compensation Guidelines, attached as
Exhibit 10.98 to Aastroms Quarterly Report on Form 10-Q for
the quarter ended March 31, 2008, incorporated herein by
reference. |
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10.23 |
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Common Stock Purchase Agreement between Aastrom and Fusion
Capital Fund II, LLC dated October 27, 2008, attached as
Exhibit 10.1 to Aastroms Current Report on Form 8-K filed on
October 29, 2008, incorporated herein by reference. |
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10.24 |
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Registration Rights Agreement between Aastrom and Fusion
Capital Fund II, LLC dated October 27, 2008, attached as
Exhibit 10.2 to Aastroms Current Report on Form 8-K filed on
October 29, 2008, incorporated herein by reference. |
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10.25 |
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Common Stock Purchase Agreement between Aastrom and Fusion
Capital Fund II, LLC dated June 12, 2009, attached as Exhibit
10.1 to Aastroms Current Report on Form 8-K filed on June 12,
2009, incorporated herein by reference. |
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10.26 |
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Registration Rights Agreement between Aastrom and Fusion
Capital Fund II, LLC dated June 12, 2009, attached as Exhibit
10.2 to Aastroms Current Report on Form 8-K dated June 12,
2009, incorporated herein by reference. |
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10.27 |
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Amendment to Employment Agreement and Option Agreement between
Aastrom and George W. Dunbar dated October 23, 2009, attached
as Exhibit 99.1 to Aastroms Current Report on Form 8-K filed
on October 27, 2009, incorporated herein by reference. |
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10.28 |
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Consulting Agreement between Aastrom and Timothy M. Mayleben
dated October 23, 2009, attached as Exhibit 99.2 to Aastroms
Current Report on Form 8-K filed on October 27, 2009,
incorporated herein by reference. |
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10.29 |
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Executive Employment Agreement between Aastrom and Timothy M.
Mayleben dated October 23, 2009, attached as Exhibit 99.3 to
Aastroms Current Report on Form 8-K filed on October 27,
2009, incorporated herein by reference. |
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21 |
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Subsidiaries of Registrant, attached as Exhibit 21 to
Aastroms Annual Report on Form 10-K for the year ended June
30, 2008, incorporated herein by reference. |
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23* |
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Consent of Independent Registered Public Accounting Firm. |
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24 |
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Powers of Attorney (included on signature page). |
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* |
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Filed herewith. |
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+ |
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Previously filed. |
Item 17. Undertakings
(a) The
undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of the
registration statement (or the most recent post-effective amendment thereof) which, individually or
in the aggregate, represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and
any deviation from the low or high end of the estimated maximum offering range may be reflected in
the form of prospectus filed with the Commission pursuant to Rule 424(b) (§ 230.424(b) of this
chapter) if, in the aggregate, the changes in volume and price represent no more than a 20 percent
change in the maximum aggregate offering price set forth in the Calculation of Registration Fee
table in the effective registration statement; and
(iii) To include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to such information in
the registration statement.
II-4
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under the Securities Act of 1933 to any
purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule 430B or other than
prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the
registration statement as of the date it is first used after effectiveness. Provided, however, that
no statement made in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference into the
registration statement or prospectus that is part of the registration statement will, as to a
purchaser with a time of contract of sale prior to such first use, supersede or modify any
statement that was made in the registration statement or prospectus that was part of the
registration statement or made in any such document immediately prior to such date of first use.
(5) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the Registrant pursuant to the
foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Act and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the Registrant of expenses incurred or paid by a
director, officer or controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with
the securities being registered, the Registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
II-5
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant has duly caused
this Post Effective Amendment No. 1 to the Registration Statement on Form S-1 to be signed on its
behalf by the undersigned, thereunto duly authorized in the City of Ann Arbor, State of Michigan,
on March 31, 2010.
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AASTROM BIOSCIENCES, INC.
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By: |
/s/ Timothy M. Mayleben
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Timothy M. Mayleben |
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Chief Executive Officer, President and Chief
Financial Officer |
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|
Each person whose signature appears below hereby constitutes and appoints each of Timothy M.
Mayleben and Julie Caudill, or either of them, as his true and lawful attorneys-in-fact and agents,
with full power of substitution and resubstitution, for him and in his name, place and stead, in
any and all capacities, to sign any or all amendments (including, without limitation,
post-effective amendments) to this Post Effective Amendment No. 1 to the Registration Statement on
Form S-1, the Registration Statement on Form S-1 and any subsequent registration statement filed by
the Registrant pursuant to Rule 462(b) of the Securities Act of 1933, which relates to the
Registration Statement on Form S-1, and to file the same, with all exhibits thereto, and all
documents in connection herewith, with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, full power and authority to do and perform each and every act and
thing requisite and necessary to be done in and about the premises, as fully to all intents and
purposes as he might or could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents, or his or her substitutes, may lawfully do or cause to be done by
virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this Post Effective Amendment No.
1 to the Registration Statement on Form S-1 has been signed by the following persons in the
capacities and on the dates indicated.
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Signature |
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Title |
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Date |
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/s/ Timothy M. Mayleben
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Chief Executive Officer, President,
Chief Financial Officer and Director
(Principal Executive,
Financial and Accounting Officer)
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March 31, 2010 |
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/s/ George W. Dunbar
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Chairman of the Board
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March 31, 2010 |
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/s/ Alan L. Rubino
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Director
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March 31, 2010 |
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/s/ Nelson M. Sims
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Director
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March 31, 2010 |
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/s/ Harold C. Urschel, Jr., M.D.
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Director
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March 31, 2010 |
Harold C. Urschel, Jr., M.D.
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Director |
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II-6
EXHIBIT INDEX
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Exhibit No. |
|
Description |
|
|
3.1 |
|
|
Restated Articles of Incorporation of Aastrom, filed as Exhibit 4.1 to Aastroms Current Report
on Form 8-K filed on December 17, 2009 and incorporated herein by reference. |
|
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3.2* |
|
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Certificate of Amendment to Restated Articles of Incorporation of Aastrom dated February 9, 2010. |
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3.3 |
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Bylaws of Aastrom, as amended, filed as Exhibit 3.2 to Aastroms Current Report on Form 8-K
filed on October 23, 2008 and incorporated herein by reference. |
|
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5.1+ |
|
|
Opinion of Dykema Gossett PLLC. |
|
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|
|
10.1 |
|
|
Form of Indemnification Agreement, attached as Exhibit 10.1 to Aastroms Registration Statement
on Form S-1 (No. 333-15415), filed on November 1, 1996 and incorporated herein by reference. |
|
|
|
|
|
|
10.2 |
|
|
Amended and Restated 1992 Incentive and Non-Qualified Stock Option Plan and forms of agreements
thereunder, attached as Exhibit 10.5 to Aastroms Registration Statement on Form S-1 (No.
333-15415), filed on November 1, 1996, incorporated herein by reference. |
|
|
|
|
|
|
10.3 |
|
|
Form of Employment Agreement, attached as Exhibit 10.8 to Aastroms Registration Statement on
Form S-1 (No. 333-15415), filed on November 1, 1996, incorporated herein by reference. |
|
|
|
|
|
|
10.4 |
|
|
License Agreement, dated July 17, 1992, between J.G. Cremonese and Aastrom and related addenda
thereto dated July 14, 1992 and July 7, 1993, attached as Exhibit 10.11 to Aastroms
Registration Statement on Form S-1 (No. 333-15415), filed on November 1, 1996, incorporated
herein by reference. |
|
|
|
|
|
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10.5 |
|
|
License Agreement, dated March 13, 1992, between Aastrom and the University of Michigan and
amendments thereto dated March 13, 1992, October 8, 1993 and June 21, 1995, attached as Exhibit
10.17 to Aastroms Registration Statement on Form S-1 (No. 333-15415), filed on November 1,
1996, incorporated herein by reference. |
|
|
|
|
|
|
10.6 |
|
|
Aastrom Biosciences 2001 Stock Option Plan, attached as Exhibit
10.72 to Aastroms Annual Report on Form 10-K for the year ended
June 30, 2002, incorporated herein by reference. |
|
|
|
|
|
|
10.7 |
|
|
Master Supply Agreement with Astro Instrumentation, LLC, attached as
Exhibit 10.76 to Aastroms Annual Report on Form 10-K for the year
ended June 30, 2003, incorporated herein by reference. |
|
|
|
|
|
|
10.8 |
|
|
Supply Agreement between Aastrom and Moll Industries, Inc., dated
December 16, 2003, attached as Exhibit 10.77 to Aastroms Annual
Report on Form 10-K for the year ended June 30, 2004, incorporated
herein by reference. |
|
|
|
|
|
|
10.9 |
|
|
2004 Equity Incentive Plan, attached as Exhibit 10.82 to Amendment
No. 1 to Aastroms Quarterly Report on Form 10-Q/A for the quarter
ended September 30, 2004, incorporated herein by reference. |
|
|
|
|
|
|
10.10 |
|
|
Form of Option and Restricted Stock Award Agreements for Grants
under 2004 Equity Incentive Plan, attached as Exhibit 10.84 to
Aastroms Annual Report on Form 10-K for the year ended June 30,
2005, incorporated herein by reference. |
|
|
|
|
|
|
10.11 |
|
|
Employee Compensation Guidelines, attached as Exhibit 10.85 to
Aastroms Annual Report on Form 10-K for the year ended June 20,
2005, incorporated herein by reference. |
|
|
|
|
|
|
10.12 |
|
|
Amendment dated December 5, 2002 to License Agreement with the
University of Michigan, attached as Exhibit 10.87 to Aastroms
Annual Report on Form 10-K for the year ended June 30, 2005,
incorporated herein by reference. |
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
10.13 |
|
|
Employment Agreement with George W. Dunbar dated July 17, 2006,
attached as Exhibit 99.1 to Aastroms Current Report on Form 8-K
filed on July 18, 2006, incorporated herein by reference. |
|
|
|
|
|
|
10.14 |
|
|
Summary of Changes to Employee Compensation Guidelines, attached as
Exhibit 10.94 to Aastroms Quarterly Report on Form 10-Q for the
quarter ended December 31, 2006, incorporated herein by reference. |
|
|
|
|
|
|
10.15 |
|
|
2004 Equity Incentive Plan, as amended, attached as Exhibit 99.1 to
Aastroms Current Report on Form 8-K filed on November 8, 2006,
incorporated herein by reference. |
|
|
|
|
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10.16 |
|
|
Forms of Grant Notice and Stock Option Agreement for Grants under
2004 Equity Incentive Plan, as amended, attached as Exhibit 99.2 to
Aastroms Current Report on Form 8-K filed on November 8, 2006,
incorporated herein by reference. |
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10.17 |
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Placement Agency Agreement, dated October 15, 2007, by and between
the Company and BMO Capital Markets Corp., attached as Exhibit 10.1
to Aastroms Current Report on Form 8-K filed on October 16, 2007,
incorporated herein by reference. |
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10.18 |
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Escrow Agreement, dated as of October 15, 2007, among the Company,
BMO Capital Markets Corp. and The Bank of New York, attached as
Exhibit 10.2 to Aastroms Current Report on Form 8-K filed on
October 16, 2007, incorporated herein by reference. |
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10.19 |
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Form of Purchase Agreement, attached as Exhibit 10.3 to Aastroms
Current Report on Form 8-K filed on October 16, 2007, incorporated
herein by reference. |
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10.20 |
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Form of Warrant, attached as Exhibit 10.2 to Aastroms Current
Report on Form 8-K filed on October 16, 2007, incorporated herein by
reference. |
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10.21 |
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|
Standard Lease between Aastrom and Dominos Farms Office Park,
L.L.C. dated January 31, 2007, attached as Exhibit 10.96 to
Amendment No. 2 to Aastroms Annual Report on Form 10-K for the year
ended June 30, 2007, incorporated herein by reference. |
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10.22 |
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Nonemployee Director Compensation Guidelines, attached as Exhibit
10.98 to Aastroms Quarterly Report on Form 10-Q for the quarter
ended March 31, 2008, incorporated herein by reference. |
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10.23 |
|
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Common Stock Purchase Agreement between Aastrom and Fusion Capital
Fund II, LLC dated October 27, 2008, attached as Exhibit 10.1 to
Aastroms Current Report on Form 8-K filed on October 29, 2008,
incorporated herein by reference. |
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10.24 |
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Registration Rights Agreement between Aastrom and Fusion Capital
Fund II, LLC dated October 27, 2008, attached as Exhibit 10.2 to
Aastroms Current Report on Form 8-K filed on October 29, 2008,
incorporated herein by reference. |
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10.25 |
|
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Common Stock Purchase Agreement between Aastrom and Fusion Capital
Fund II, LLC dated June 12, 2009, attached as Exhibit 10.1 to
Aastroms Current Report on Form 8-K filed on June 12, 2009,
incorporated herein by reference. |
|
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10.26 |
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Registration Rights Agreement between Aastrom and Fusion Capital
Fund II, LLC dated June 12, 2009, attached as Exhibit 10.2 to
Aastroms Current Report on Form 8-K dated June 12, 2009,
incorporated herein by reference. |
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10.27 |
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|
Amendment to Employment Agreement and Option Agreement between
Aastrom and George W. Dunbar dated October 23, 2009, attached as
Exhibit 99.1 to Aastroms Current Report on Form 8-K filed on
October 27, 2009, incorporated herein by reference. |
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10.28 |
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Consulting Agreement between Aastrom and Timothy M. Mayleben dated
October 23, 2009, attached as Exhibit 99.2 to Aastroms Current
Report on Form 8-K filed on October 27, 2009, incorporated herein by
reference. |
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10.29 |
|
|
Executive Employment Agreement between Aastrom and Timothy M.
Mayleben dated October 23, 2009, attached as Exhibit 99.3 to
Aastroms Current Report on Form 8-K filed on October 27, 2009,
incorporated herein by reference. |
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Exhibit No. |
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Description |
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21 |
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Subsidiaries of Registrant, attached as Exhibit 21 to Aastroms
Annual Report on Form 10-K for the year ended June 30, 2008,
incorporated herein by reference. |
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23* |
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Consent of Independent Registered Public Accounting Firm. |
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24 |
|
|
Powers of Attorney (included on signature page). |
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* |
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Filed herewith. |
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+ |
|
Previously filed. |
exv3w2
Exhibit
3.2
CERTIFICATE OF AMENDMENT
TO THE RESTATED ARTICLES OF INCORPORATION
OF
AASTROM BIOSCIENCES, INC.
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1 |
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The present name of the corporation is: |
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Aastrom Biosciences, Inc. |
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2 |
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The identification number assigned by the Bureau is: |
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529-456 |
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3 |
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All former names of the corporation are: |
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Ann Arbor Stromal, Inc. |
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4 |
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The date of filing the original Articles of Incorporation was: |
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March24, 1989 |
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5 |
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The following language is hereby added to the end of Article III of the Restated Articles of Incorporation: |
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Effective at 9:00 a.m. EST, on February 18, 2010, every eight outstanding shares of
Common Stock will be combined into and automatically become one share of outstanding Common
Stock of the Corporation. The Corporation will not issue fractional shares on account of the
foregoing reverse stock split; all shares that are held by a shareholder as of the effective
date hereof shall be aggregated and each fractional share resulting from the reverse stock
split after giving effect to such aggregation shall be cancelled. In lieu of any interest in
a fractional share to which a shareholder would otherwise be entitled as a result of such
reverse stock split, such shareholder will be paid a cash amount for such fractional shares
equal to the product obtained by multiplying (a) the fraction to which the shareholder would
otherwise be entitled by (b) the per share closing price of the Corporations Common Stock on
the trading day immediately prior to the effective time of the Reverse Stock Split, as such
price is reported on the NASDAQ Capital Market. |
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6 |
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The number of authorized shares of common stock shall be reduced to 62,500,000 by virtue of
this Certificate of Amendment. |
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7 |
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The foregoing amendment to the Restated Articles of Incorporation was duly adopted on the
29th day of January, 2010 pursuant to the authorization of the shareholders of the
corporation on the 14th day of December, 2009 at the annual meeting of the
corporations shareholders, where the necessary votes were cast in favor of the amendment. |
Signed this 9th day of February, 2010.
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Aastrom Biosciences, Inc.
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By: |
/s/ Julie Caudill
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Julie Caudill |
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Corporate Secretary |
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exv23
EXHIBIT 23
Consent of Independent Registered Public Accounting Firm
We hereby consent to the incorporation by reference in this Post Effective Amendment No. 1 to
Registration Statement on Form S-1 of our report dated September 14, 2009 relating to the financial
statements and the effectiveness of internal control over financial reporting, which appears in
Aastrom Biosciences, Inc.s Annual Report on Form 10-K for the year ended June 30, 2009. We also
consent to the reference to us under the heading Experts in such Registration Statement.
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/s/ PricewaterhouseCoopers LLP
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| |
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PricewaterhouseCoopers LLP |
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Detroit, Michigan |
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|
March 31, 2010 |
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