As
filed with the Securities and Exchange Commission on June 11, 2009
Registration
No. 333-
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
S-3
REGISTRATION
STATEMENT
THE
SECURITIES ACT OF 1933
CYTORI
THERAPEUTICS, INC.
(Exact
Name of Registrant as Specified in its Charter)
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Delaware
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33-0827593
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(State
or Other Jurisdiction of Incorporation or Organization)
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(I.R.S.
Employer Identification No.)
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3020
Callan Road
San
Diego, CA 92121
(858)
458-0900
(Address,
Including Zip Code and Telephone Number, Including
Area
Code, of Registrant’s Principal Executive Offices)
Christopher
J. Calhoun
Chief
Executive Officer
Cytori
Therapeutics, Inc.
3020
Callan Road
San
Diego, CA 92121
(858)
458-0900
(Name,
Address, Including Zip Code and Telephone Number, Including
Area
Code, of Agent for Service)
With
a Copy to:
Jeffrey
T. Baglio
DLA
Piper LLP (US)
4365
Executive Drive, Suite 1100
San
Diego, CA 92121
Approximate date of commencement of
proposed sale to the public: From time to time after the
effective date of this Registration Statement.
If the
only securities being registered on this Form are being offered pursuant to
dividend or interest reinvestment plans, please check the following
box.
If any of
the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other
than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. þ
If this
Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering.
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.
If this
form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box.
If this
form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b) under the Securities Act, check
the following box.
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 definition of “large accelerated filer,” “accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange
Act.
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Large
accelerated filer
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Accelerated
filer þ
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Non-accelerated
filer
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Smaller
reporting
company
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CALCULATION
OF REGISTRATION FEE
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Title
of Each Class of
Securities
to be Registered
|
Amount
to be
Registered(1)
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Proposed
Maximum
Offering
Price
per Share(2)
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Proposed
Maximum Aggregate
Offering
Price
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Amount
of Registration
Fee
|
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Common
Stock, $0.001 par value per share
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5,128,163
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$4.41
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$22,615,199
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$1,262
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(1)
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Includes
3,263,380 shares of common stock that may be issued upon the exercise of
warrants. Pursuant to Rule 416 under the Securities Act of 1933, as
amended, this registration statement also covers such additional shares as
may hereafter be offered or issued with respect to the shares registered
hereby resulting from stock splits, stock dividends, recapitalizations or
similar capital adjustments.
|
|
(2)
|
Estimated
solely for purposes of calculating the amount of the registration fee
pursuant to Rule 457(c) of the Securities Act of 1933, as amended, based
upon the average of the high and low sales prices of the registrant’s
common stock as reported on The NASDAQ Global Market on June 8,
2009.
|
The
Registrant hereby amends this Registration Statement on such date or dates as
may be necessary to delay its effective date until the Registrant shall file a
further amendment which specifically states that this Registration Statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933, as amended, or until the Registration Statement shall
become effective on such date as the Securities and Exchange Commission, acting
pursuant to said Section 8(a), may determine.
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The
information in this prospectus is not complete and may be changed. We may
not sell these securities until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an
offer to sell these securities and it is not soliciting an offer to buy
these securities in any state where the offer or sale is not
permitted.
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SUBJECT
TO COMPLETION, DATED JUNE 11, 2009
PRELIMINARY
PROSPECTUS
5,128,163
Shares
CYTORI
THERAPEUTICS, INC.
Common
Stock
This
prospectus relates to the resale from time to time of up to 5,128,163 shares of
our common stock, which includes 3,263,380 shares of our common stock issuable
upon the exercise of warrants, by the selling stockholders named in this
prospectus. We are not selling any securities under this prospectus and will not
receive any of the proceeds from the sale of shares by the selling
stockholders.
The
selling stockholders may sell the shares of common stock being offered by this
prospectus from time to time on terms to be determined at the time of sale
through ordinary brokerage transactions or through any other means described in
this prospectus under “Plan of Distribution.” The selling stockholders may sell
the shares in negotiated transactions or otherwise, at the prevailing market
price for the shares or at negotiated prices. We will not be paying any
underwriting discounts or commissions in this offering.
Our
common stock is listed on The NASDAQ Global Market under the symbol “CYTX.” On
June 9, 2009, the last reported sale price of our common stock on The
NASDAQ Global Market was $4.36 per share.
Investing
in our common stock involves a high degree of risk. You are urged to read the
section entitled “Risk Factors” beginning on page 2 of this prospectus, which
describes specific risks and other information that should be considered before
you make an investment decision.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is
truthful or complete. Any representation to the contrary is a criminal
offense.
The date
of this prospectus is ____________, 2009.
TABLE
OF CONTENTS
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Page
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12
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13
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14
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18
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21
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21
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21
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21
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Exhibit
5.1
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Exhibit
23.1
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You
should rely only on the information contained in or incorporated by reference
into this prospectus or any applicable prospectus supplement. We have not, and
the selling stockholders have not, authorized anyone to provide you with
different information. Neither we nor the selling stockholders are making an
offer to sell or seeking an offer to buy shares of our common stock under this
prospectus or any applicable prospectus supplement in any jurisdiction where the
offer or sale is not permitted. The information contained in this prospectus,
any applicable prospectus supplement and the documents incorporated by reference
herein and therein are accurate only as of their respective dates, regardless of
the time of delivery of this prospectus or any sale of a security. Our business,
financial condition, results of operations and prospects may have changed since
that date.
This
summary highlights information contained elsewhere or incorporated by reference
into this prospectus. Because it is a summary, it does not contain all of the
information that you should consider before investing in our securities. You
should read this entire prospectus carefully, including the section entitled
“Risk Factors” and the documents that we incorporate by reference into this
prospectus, before making an investment decision. References to “we,” “us,”
“our,” “our company,” “the Company,” and “CYTX” refers to Cytori Therapeutics,
Inc. and its subsidiaries, unless the context requires otherwise.
About
Cytori Therapeutics, Inc.
Cytori
Therapeutics, Inc., develops, manufactures, and sells medical products to enable
the practice of regenerative medicine. Regenerative medicine describes the
emerging field that aims to repair or restore lost or damaged tissue and cell
function. Our commercial activities are currently focused on cosmetic and
reconstructive surgery in Europe and Asia-Pacific, fulfilling the demand among
physicians in Europe and Asia Pacific for clinical grade stem and regenerative
cells, and stem and regenerative cell banking (cell preservation)
worldwide. In addition, we are seeking to bring our products to
market in the United States as well as other countries. Our product pipeline
includes the development of potential new treatments for cardiovascular disease,
spinal disc degeneration, gastrointestinal disorders, liver and renal disease
and pelvic health conditions.
The
foundation of our business is the patented Celution® System
family of products which processes patients’ cells at the bedside in real time.
Each member of the Celution® System
family of products consists of a central device, a related single-use consumable
used for each patient procedure, proprietary enzymes, and related
instrumentation. Our commercialization model is based on the sale of
Celution® Systems
and on generating recurring revenues from the single-use consumable
sets.
Our
Celution® 800/CRS
System was introduced during 2008 into the European cosmetic and reconstructive
surgery market through a network of medical distributors. The Celution® 900/MB
is being marketed in Japan through our commercialization partner, Green Hospital
Supply, Inc. (Green Hospital Supply) as part of the comprehensive
StemSource® Cell
Bank, which prepares cells for cryopreservation in the event they may be used in
the future.
The most
advanced therapeutic application in our product development pipeline is
cardiovascular disease. Currently, two cardiovascular clinical trials are being
conducted in Europe with adipose-derived stem and regenerative cells, processed
with the Celution® 600
System, an earlier version of the Celution® 800/CV.
The Celution® 800/CV
has recently been introduced to these clinical sites. One of the clinical trials
is in patients suffering from chronic myocardial ischemia, a severe form of
chronic heart disease, and the other is in heart attack patients.
We were
initially formed as a California general partnership in July 1996, and
incorporated in the State of Delaware in May 1997. We were formerly known as
MacroPore Biosurgery, Inc., and before that as MacroPore, Inc. Our
corporate offices are located at 3020 Callan Road, San Diego, CA 92121. Our
telephone number is (858) 458-0900. Our website address is www.cytoritx.com. We
make available free of charge through our Internet website our annual report on
Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and
amendments to those reports filed or furnished pursuant to Section 13(a) or
15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act,
as soon as reasonably practicable after we electronically file such material
with, or furnish it to, the SEC. Information contained on our website does not
constitute part of this prospectus or any prospectus supplement.
1
You
should carefully consider the following information about risks and
uncertainties that may affect us or our business, together with the other
information appearing elsewhere in this prospectus. If any of the following
events, described as risks, actually occur, our business, financial condition,
results of operations and future growth prospects would likely be materially and
adversely affected. In these circumstances, the market price of our common stock
could decline, and you may lose all or part of your investment in our
securities. An investment in our securities is speculative and involves a high
degree of risk. You should not invest in our securities if you cannot bear the
economic risk of your investment for an indefinite period of time and cannot
afford to lose your entire investment.
We need to raise more cash
in the near term
We have
almost always had negative cash flows from operations. Our business
will continue to result in a substantial requirement for research and
development expenses for several years, during which we may not be able to bring
in sufficient cash and/or revenues to offset these expenses. We will
be required to raise capital from one or more sources in the near term to
continue our operations at or close to the levels currently
conducted. If we are not successful in maintaining
adequate cash reserves we will be required to negotiate with General Electric
Capital Corporation (“GECC”) and Silicon Valley Bank (“SVB”) to obtain an
amendment to the cash liquidity requirements of the Loan and Security Agreement
dated October 14, 2008 (“Loan Agreement”). If we are not successful in
maintaining adequate cash liquidity and such provisions are not waived then we
could be in default under the Loan Agreement. If we are in default or if our
senior secured lenders otherwise assert that there has been an event of default,
they may seek to accelerate our senior secured loan and exercise their rights
and remedies under the Loan Agreement, including the sale of our property and
other assets. In such event, we may be forced to file a bankruptcy case or
have an involuntary bankruptcy case filed against us or otherwise liquidate our
assets. Any of these events would have a substantial and material adverse
effect on our business, financial condition, results of operations, the value of
our common stock and warrants and our ability to raise capital. There
is no guarantee that adequate funds will be available when needed from
additional debt or equity financing, arrangements with distribution partners,
increased results of operations, or from other sources, or on terms attractive
to us. Although we entered into a $15,000,000 loan facility with GECC
and SVB in October 2008, we could not access the remaining $7,500,000 under that
facility as we were not able satisfy certain financial conditions on or before
December 12, 2008. Our inability to maintain sufficient operating
funds in the near term could, necessitate that we delay, scale back, or
eliminate some or all of our research or product development, manufacturing
operations, clinical or regulatory activities, which could have a substantial
negative effect on our results of operations and financial
condition.
Continued turmoil in the
economy could harm our business
Negative
trends in the general economy, including trends resulting from an actual or
perceived recession, tightening credit markets, increased cost of commodities,
including oil, actual or threatened military action by the United States and
threats of terrorist attacks in the United States and abroad, could cause a
reduction of investment in and available funding for companies in certain
industries, including ours. Our ability to raise capital has been and
may continue to be adversely affected by current credit conditions and the
downturn in the financial markets and the global economy.
We have never been
profitable on an operational basis and expect significant operating losses for
the next few years
We have
incurred net operating losses in each year since we started
business. As our focus on the Celution® System
platform and development of therapeutic applications for its cellular output has
2
increased,
losses have resulted primarily from expenses associated with research and
development activities and general and administrative expenses. While
we are implementing cost reduction measures where possible, we nonetheless
expect to continue operating in a loss position on a consolidated basis and that
recurring operating expenses will be at high levels for the next several years,
in order to perform clinical trials, additional pre-clinical research, product
development, and marketing. As a result of our historic losses, we
have historically been, and continue to be, reliant on raising outside capital
to fund our operations as discussed in the prior risk factor.
Our business strategy is
high-risk
We are
focusing our resources and efforts primarily on development of the Celution® System
family of products and the therapeutic applications of its cellular output,
which requires extensive cash needs for research and development
activities. This is a high-risk strategy because there is no
assurance that our products will ever become commercially viable (commercial
risk), that we will prevent other companies from depriving us of market share
and profit margins by selling products based on our inventions and developments
(legal risk), that we will successfully manage a company in a new area of
business (regenerative medicine) and on a different scale than we have operated
in the past (operational risk), that we will be able to achieve the desired
therapeutic results using stem and regenerative cells (scientific risk), or that
our cash resources will be adequate to develop our products until we become
profitable, if ever (financial risk). We are using our cash in one of
the riskiest industries in the economy (strategic risk). This may
make our stock an unsuitable investment for many investors.
We must keep our joint
venture with Olympus operating smoothly
Our
business cannot succeed on the currently anticipated timelines unless our Joint
Venture collaboration with Olympus goes well. We have given
Olympus-Cytori, Inc. an exclusive license to manufacture future generation
Celution® System
devices. If Olympus-Cytori, Inc. does not successfully develop and
manufacture these devices, we may not be able to commercialize any device or any
therapeutic products successfully into the market. In addition,
future disruption or breakup of our relationship would be extremely costly to
our reputation, in addition to causing many serious practical
problems.
We and
Olympus must overcome contractual and cultural barriers. Our
relationship is formally measured by a set of complex contracts, which have not
yet been tested in practice. In addition, many aspects of the
relationship will be non-contractual and must be worked out between the parties
and the responsible individuals. The Joint Venture is intended to
have a long life, and it is difficult to maintain cooperative relationships over
a long period of time in the face of various kinds of
change. Cultural differences, including language barrier to some
degree, may affect the efficiency of the relationship.
Olympus-Cytori,
Inc. is 50% owned by us and 50% owned by Olympus. By contract, each
side must consent before any of a wide variety of important business actions can
occur. This situation possesses a risk of potentially time-consuming
and difficult negotiations which could at some point delay the Joint Venture
from pursuing its business strategies.
Olympus
is entitled to designate the Joint Venture's chief executive officer and a
majority of its board of directors, which means that day-to-day decisions which
are not subject to a contractual veto will essentially be controlled by
Olympus. In addition, Olympus-Cytori, Inc. may require more money
than its current capitalization in order to complete development and production
of future generation devices. If we are unable to help provide future
financing for Olympus-Cytori, Inc., our relative equity interest in
Olympus-Cytori, Inc. may decrease.
3
Furthermore,
under a License/Joint Development Agreement among Olympus-Cytori, Inc., Olympus,
and us, Olympus will have a primary role in the development of Olympus-Cytori,
Inc.’s next generation devices. Although Olympus has extensive
experience in developing medical devices, this arrangement will result in a
reduction of our control over the development and manufacturing of the next
generation devices.
We have a limited operating
history; operating results and stock price can be volatile like many life
science companies
Our
prospects must be evaluated in light of the risks and difficulties frequently
encountered by emerging companies and particularly by such companies in rapidly
evolving and technologically advanced biotech and medical device
fields. Due to limited operating history and the transition from the
MacroPore biomaterials to the regenerative medicine business, comparisons of our
year-to-year operating results are not necessarily meaningful and the results
for any periods should not necessarily be relied upon as an indication of future
performance. All 2007 product revenues came from our spine and
orthopedics implant product line, which we sold in May 2007.
From time
to time, we have tried to update our investors’ expectations as to our operating
results by periodically announcing financial guidance. However, we
have in the past been forced to revise or withdraw such guidance due to lack of
visibility and predictability of product demand.
We are vulnerable to
competition and technological change, and also to physicians’
inertia
We
compete with many domestic and foreign companies in developing our technology
and products, including biotechnology, medical device, and pharmaceutical
companies. Many current and potential competitors have substantially
greater financial, technological, research and development, marketing, and
personnel resources. There is no assurance that our competitors will
not succeed in developing alternative products that are more effective, easier
to use, or more economical than those which we have developed or are in the
process of developing, or that would render our products obsolete and
non-competitive. In general, we may not be able to prevent others
from developing and marketing competitive products similar to ours or which
perform similar functions.
Competitors
may have greater experience in developing therapies or devices, conducting
clinical trials, obtaining regulatory clearances or approvals, manufacturing and
commercialization. It is possible that competitors may obtain patent
protection, approval, or clearance from the FDA or achieve commercialization
earlier than we can, any of which could have a substantial negative effect on
our business. Finally, Olympus and our other partners might pursue
parallel development of other technologies or products, which may result in a
partner developing additional products competitive with ours.
We
compete against cell-based therapies derived from alternate sources, such as
bone marrow, umbilical cord blood and potentially embryos. Doctors
historically are slow to adopt new technologies like ours, whatever the merits,
when older technologies continue to be supported by established
providers. Overcoming such inertia often requires very significant
marketing expenditures or definitive product performance and/or pricing
superiority.
We expect
physicians’ inertia and skepticism to also be a significant barrier as we
attempt to gain market penetration with our future products. We believe we will
need to finance lengthy time-consuming clinical studies (so as to provide
convincing evidence of the medical benefit) in order to overcome this inertia
and skepticism particularly in reconstructive surgery, cell preservation, the
cardiovascular area and many other indications.
4
Most potential applications
of our technology are pre-commercialization, which subjects us to development
and marketing risks
We are in
a relatively early stage of the path to commercialization with many of our
products. We believe that our long-term viability and growth will
depend in large part on our ability to develop commercial quality cell
processing devices and useful procedure-specific consumables, and to establish
the safety and efficacy of our therapies through clinical trials and
studies. With our Celution®
platform, we are pursuing new approaches for reconstructive surgery,
preservation of stem and regenerative cells for potential future use, therapies
for cardiovascular disease, gastrointestinal disorders and spine and orthopedic
conditions. There is no assurance that our development programs will
be successfully completed or that required regulatory clearances or approvals
will be obtained on a timely basis, if at all.
There is
no proven path for commercializing the Celution® System
platform in a way to earn a durable profit commensurate with the medical
benefit. Although we began to commercialize our reconstructive
surgery products in Europe and certain Asian markets, and our cell banking
products in Japan, Europe, and certain Asian markets in 2008, additional market
opportunities for our products and/or services are likely to be another two to
five years away.
Successful
development and market acceptance of our products is subject to developmental
risks, including failure of inventive imagination, ineffectiveness, lack of
safety, unreliability, failure to receive necessary regulatory clearances or
approvals, high commercial cost, preclusion or obsolescence resulting from third
parties’ proprietary rights or superior or equivalent products, competition from
copycat products, and general economic conditions affecting purchasing
patterns. There is no assurance that we or our partners will
successfully develop and commercialize our products, or that our competitors
will not develop competing technologies that are less expensive or
superior. Failure to successfully develop and market our products
would have a substantial negative effect on our results of operations and
financial condition.
The timing and amount of
Thin Film revenues from Senko are uncertain
The sole
remaining product line in our MacroPore Biosurgery segment is our Japan Thin
Film business. Our right to receive royalties from Senko, and to
recognize certain deferred revenues, depends on the timing of MHLW approval for
commercialization of the product in Japan. We have no control over
this timing and our previous expectations have not been met. Also,
even after commercialization, we will be dependent on Senko, our exclusive
distributor, to drive product sales in Japan.
There is
a risk that we could experience with Senko some of the same problems we
experienced in our previous relationship with Medtronic, which was the exclusive
distributor for our former bioresorbable spine and orthopedic implant product
line.
We have limited
manufacturing experience
We have
limited experience in manufacturing the Celution® System
platform or its consumables at a commercial level. With respect to
our Joint Venture, although Olympus is a highly capable and experienced
manufacturer of medical devices, there can be no guarantee that the
Olympus-Cytori Joint Venture will be able to successfully develop and
manufacture the next generation Celution® device
in a manner that is cost-effective or commercially viable, or that development
and manufacturing capabilities might not take much longer than currently
anticipated to be ready for the market.
5
Although
we have begun introduction of the Celution® 800 and
the Celution®
900-based StemSource® Cell
Bank in 2008, we cannot assure that we will be able to manufacture sufficient
numbers of such products to meet the demand, or that we will be able to overcome
unforeseen manufacturing difficulties for these sophisticated medical devices,
as we await the availability of the Joint Venture next generation Celution®
device.
In the
event that the Olympus-Cytori Joint Venture is not successful, Cytori may not
have the resources or ability to self-manufacture sufficient numbers of devices
and consumables to meet market demand, and this failure may substantially extend
the time it would take for us to bring a more advanced commercial device to
market. This makes us significantly dependant on the continued dedication and
skill of Olympus for the successful development of the next generation
Celution®
device.
We may not be able to
protect our proprietary rights
Our
success depends in part on whether we can maintain our existing patents, obtain
additional patents, maintain trade secret protection, and operate without
infringing on the proprietary rights of third parties.
Our
amended regenerative cell technology license agreement with the Regents of the
University of California, or the UC, contains certain developmental milestones,
which if not achieved could result in the loss of exclusivity or loss of the
license rights. The loss of such rights could impact our ability to develop
certain regenerative cell technology products. Also, our power as
licensee to successfully use these rights to exclude competitors from the market
is untested. In addition, further legal risk arises from a lawsuit
filed by the University of Pittsburgh in the United States District Court, or
the Court, naming all of the inventors who had not assigned their ownership
interest in Patent 6,777,231, which we refer to as the ‘231 Patent, to the
University of Pittsburgh, seeking a determination that its assignors, rather
than UC’s assignors, are the true inventors of ‘231 Patent. On June
12, 2008, we received the Court’s final order concluding that the University of
Pittsburgh’s assignors were the sole inventors of the ‘231 Patent, which
terminates UC’s rights to this patent unless the decision of the Court is
overturned. The UC assignors are appealing the Court’s decision and a
Notice of Appeal was filed on July 9, 2008. We are the exclusive,
worldwide licensee of the UC’s rights under this patent in humans, which relates
to adult stem cells isolated from adipose tissue that can differentiate into two
or more of a variety of cell types. If the UC assignors do not prevail on
appeal, our license rights to this patent will be permanently lost.
There can
be no assurance that any of our pending patent applications will be approved or
that we will develop additional proprietary products that are patentable. There
is also no assurance that any patents issued to us will provide us with
competitive advantages, will not be challenged by any third parties, or that the
patents of others will not prevent the commercialization of products
incorporating our technology. Furthermore, there can be no guarantee
that others will not independently develop similar products, duplicate any of
our products, or design around our patents.
Our
commercial success will also depend, in part, on our ability to avoid infringing
on patents issued to others. If we were judicially determined to be
infringing on any third-party patent, we could be required to pay damages, alter
our products or processes, obtain licenses, or cease certain
activities. If we are required in the future to obtain any licenses
from third parties for some of our products, there can be no guarantee that we
would be able to do so on commercially favorable terms, if at
all. U.S. patent applications are not immediately made public, so we
might be surprised by the grant to someone else of a patent on a technology we
are actively using. As noted above as to the University of Pittsburgh
lawsuit, even patents issued to us or our licensors might be judicially
determined to belong in full or in part to third parties.
6
Litigation,
which would result in substantial costs to us and diversion of effort on our
part, may be necessary to enforce or confirm the ownership of any patents issued
or licensed to us, or to determine the scope and validity of third-party
proprietary rights. If our competitors claim technology also claimed
by us and prepare and file patent applications in the United States of America,
we may have to participate in interference proceedings declared by the U.S.
Patent and Trademark Office or a foreign patent office to determine priority of
invention, which could result in substantial costs to and diversion of effort,
even if the eventual outcome is favorable to us. Any such litigation
or interference proceeding, regardless of outcome, could be expensive and
time-consuming.
In
addition to patents, which alone may not be able to protect the fundamentals of
our regenerative cell business, we also rely on unpatented trade secrets and
proprietary technological expertise. Our intended future cell-related
therapeutic products, such as consumables, are likely to fall largely into this
category. We rely, in part, on confidentiality agreements with our
partners, employees, advisors, vendors, and consultants to protect our trade
secrets and proprietary technological expertise. There can be no guarantee that
these agreements will not be breached, or that we will have adequate remedies
for any breach, or that our unpatented trade secrets and proprietary
technological expertise will not otherwise become known or be independently
discovered by competitors.
Failure
to obtain or maintain patent protection, or protect trade secrets, for any
reason (or third-party claims against our patents, trade secrets, or proprietary
rights, or our involvement in disputes over our patents, trade secrets, or
proprietary rights, including involvement in litigation), could have a
substantial negative effect on our results of operations and financial
condition.
We may not be able to
protect our intellectual property in countries outside the United
States
Intellectual
property law outside the United States is uncertain and in many countries is
currently undergoing review and revisions. The laws of some countries
do not protect our patent and other intellectual property rights to the same
extent as United States laws. This is particularly relevant to us as
we currently conduct most of our clinical trials outside of the United
States. Third parties may attempt to oppose the issuance of patents
to us in foreign countries by initiating opposition proceedings. Opposition
proceedings against any of our patent filings in a foreign country could have an
adverse effect on our corresponding patents that are issued or pending in the
U.S. It may be necessary or useful for us to participate in proceedings to
determine the validity of our patents or our competitors’ patents that have been
issued in countries other than the U.S. This could result in substantial costs,
divert our efforts and attention from other aspects of our business, and could
have a material adverse effect on our results of operations and financial
condition. We currently have pending patent applications in Europe, Australia,
Japan, Canada, China, Korea, and Singapore, among others.
We and Olympus-Cytori, Inc.
are subject to intensive FDA regulation
As newly
developed medical devices, Celution® System
family of products must receive regulatory clearances or approvals from the FDA
and, in many instances, from non-U.S. and state governments prior to their
sale. The Celution® System
family of products is subject to stringent government regulation in the United
States by the FDA under the Federal Food, Drug and Cosmetic Act. The
FDA regulates the design/development process, clinical testing, manufacture,
safety, labeling, sale, distribution, and promotion of medical devices and
drugs. Included among these regulations are pre-market clearance and
pre-market approval requirements, design control requirements, and the Quality
System Regulations/Good Manufacturing Practices. Other statutory and
regulatory requirements govern, among other things, establishment registration
and inspection, medical device listing, prohibitions against misbranding and
adulteration, labeling and post-market reporting.
7
The
regulatory process can be lengthy, expensive, and uncertain. Before
any new medical device may be introduced to the United States of America market,
the manufacturer generally must obtain FDA clearance or approval through either
the 510(k) pre-market notification process or the lengthier pre-market approval
application, or PMA, process. It generally takes from three to 12
months from submission to obtain 510(k) pre-market clearance, although it may
take longer. Approval of a PMA could take four or more years from the
time the process is initiated. The 510(k) and PMA processes can be
expensive, uncertain, and lengthy, and there is no guarantee of ultimate
clearance or approval. We expect that some of our future products
under development as well as Olympus-Cytori’s will be subject to the lengthier
PMA process. Securing FDA clearances and approvals may require the
submission of extensive clinical data and supporting information to the FDA, and
there can be no guarantee of ultimate clearance or approval. Failure
to comply with applicable requirements can result in application integrity
proceedings, fines, recalls or seizures of products, injunctions, civil
penalties, total or partial suspensions of production, withdrawals of existing
product approvals or clearances, refusals to approve or clear new applications
or notifications, and criminal prosecution.
Medical
devices are also subject to post-market reporting requirements for deaths or
serious injuries when the device may have caused or contributed to the death or
serious injury, and for certain device malfunctions that would be likely to
cause or contribute to a death or serious injury if the malfunction were to
recur. If safety or effectiveness problems occur after the product
reaches the market, the FDA may take steps to prevent or limit further marketing
of the product. Additionally, the FDA actively enforces regulations
prohibiting marketing and promotion of devices for indications or uses that have
not been cleared or approved by the FDA.
There can
be no guarantee that we will be able to obtain the necessary 510(k) clearances
or PMA approvals to market and manufacture our other products in the United
States of America for their intended use on a timely basis, if at
all. Delays in receipt of or failure to receive such clearances or
approvals, the loss of previously received clearances or approvals, or failure
to comply with existing or future regulatory requirements could have a
substantial negative effect on our results of operations and financial
condition.
To sell in international
markets, we will be subject to intensive regulation in foreign
countries
In
cooperation with our distribution partners, we intend to market our current and
future products both domestically and in many foreign markets. A number of risks
are inherent in international transactions. In order for us to market
our products in Europe, Canada, Japan and certain other non-U.S. jurisdictions,
we need to obtain and maintain required regulatory approvals or clearances and
must comply with extensive regulations regarding safety, manufacturing processes
and quality. For example, we still have not obtained regulatory
approval for our Thin Film products in Japan. These regulations,
including the requirements for approvals or clearances to market, may differ
from the FDA regulatory scheme. International sales also may be
limited or disrupted by political instability, price controls, trade
restrictions and changes in tariffs. Additionally, fluctuations in
currency exchange rates may adversely affect demand for our products by
increasing the price of our products in the currency of the countries in which
the products are sold.
There can
be no assurance that we will obtain regulatory approvals or clearances in all of
the countries where we intend to market our products, or that we will not incur
significant costs in obtaining or maintaining foreign regulatory approvals or
clearances, or that we will be able to successfully commercialize current or
future products in various foreign markets. Delays in receipt of
approvals or clearances to market our products in foreign countries, failure to
receive such approvals or clearances or the future loss of previously received
approvals or clearances could have a substantial negative effect on our results
of operations and financial condition.
8
Changing, New and/or
Emerging Government Regulations
Government
regulations can change without notice. Given that fact that Cytori operates in
various international markets, our access to such markets could change with
little to no warning due to a change in government regulations that suddenly
up-regulate our product(s) and create greater regulatory burden for our cell
therapy and cell banking technology products.
Due to
the fact that there are new and emerging cell therapy and cell banking
regulations that have recently been drafted and/or implemented in various
countries around the world, the application and subsequent implementation of
these new and emerging regulations have little to no precedence. Therefore, the
level of complexity and stringency is not known and may vary from country to
country, creating greater uncertainty for the international regulatory
process.
Health Insurance
Reimbursement Risks
New and
emerging cell therapy and cell banking technologies, such as those provided by
the Celution® System
family of products, may have difficulty or encounter significant delays in
obtaining health care reimbursement in some or all countries around the world
due to the novelty of our cell therapy and cell banking technology
and subsequent lack of existing reimbursement schemes / pathways. Therefore, the
creation of new reimbursement pathways may be complex and lengthy with no
assurances that such reimbursements will be successful. The lack of health
insurance reimbursement or reduced or minimal reimbursement pricing may have a
significant impact on our ability to successfully sell our cell therapy and cell
banking technology product(s) into a county or region.
Market Acceptance of New
Technology
New and
emerging cell therapy and cell banking technologies, such as those provided by
the Celution® System
family of products, may have difficulty or encounter significant delays in
obtaining market acceptance in some or all countries around the world due to the
novelty of our cell therapy and cell banking technologies. Therefore, the market
adoption of our cell therapy and cell banking technologies may be slow and
lengthy with no assurances that significant market adoption will be successful.
The lack of market adoption or reduced or minimal market adoption of our cell
therapy and cell banking technologies may have a significant impact on our
ability to successfully sell our product(s) into a country or
region.
We and/or the Joint Venture
have to maintain quality assurance certification and manufacturing
approvals
The
manufacture of our Celution® System
will be, and the manufacture of any future cell-related therapeutic products
would be, subject to periodic inspection by regulatory authorities and
distribution partners. The manufacture of devices and products for
human use is subject to regulation and inspection from time to time by the FDA
for compliance with the FDA’s Quality System Regulation, or QSR, requirements,
as well as equivalent requirements and inspections by state and non-U.S.
regulatory authorities. There can be no guarantee that the FDA or
other authorities will not, during the course of an inspection of existing or
new facilities, identify what they consider to be deficiencies in our compliance
with QSRs or other requirements and request, or seek remedial
action.
Failure
to comply with such regulations or a potential delay in attaining compliance may
adversely affect our manufacturing activities and could result in, among other
things, injunctions, civil penalties, FDA refusal to grant pre-market approvals
or clearances of future or pending product submissions, fines, recalls or
seizures of products, total or partial suspensions of production, and criminal
prosecution. There can be no assurance after such occurrences that we
will be able to obtain additional necessary regulatory
9
approvals
or clearances on a timely basis, if at all. Delays in receipt of or
failure to receive such approvals or clearances, or the loss of previously
received approvals or clearances could have a substantial negative effect on our
results of operations and financial condition.
We depend on a few key
officers
Our
performance is substantially dependent on the performance of our executive
officers and other key scientific and sales staff, including Christopher J.
Calhoun, our Chief Executive Officer, and Marc Hedrick, MD, our
President. We rely upon them for strategic business decisions and
guidance. We believe that our future success in developing marketable products
and achieving a competitive position will depend in large part upon whether we
can attract and retain additional qualified management and scientific
personnel. Competition for such personnel is intense, and there can
be no assurance that we will be able to continue to attract and retain such
personnel. The loss of the services of one or more of our executive
officers or key scientific staff or the inability to attract and retain
additional personnel and develop expertise as needed could have a substantial
negative effect on our results of operations and financial
condition.
We may not have enough
product liability insurance
The
testing, manufacturing, marketing, and sale of our regenerative cell products
involve an inherent risk that product liability claims will be asserted against
us, our distribution partners, or licensees. There can be no
guarantee that our clinical trial and commercial product liability insurance is
adequate or will continue to be available in sufficient amounts or at an
acceptable cost, if at all. A product liability claim, product
recall, or other claim, as well as any claims for uninsured liabilities or in
excess of insured liabilities, could have a substantial negative effect on our
results of operations and financial condition. Also, well-publicized
claims could cause our stock to fall sharply, even before the merits of the
claims are decided by a court.
Our charter documents
contain anti-takeover provisions and we have adopted a Stockholder Rights Plan
to prevent hostile takeovers
Our
Amended and Restated Certificate of Incorporation and Bylaws contain certain
provisions that could prevent or delay the acquisition of the Company
by means of a tender offer, proxy contest, or otherwise. They could
discourage a third party from attempting to acquire control of Cytori, even if
such events would be beneficial to the interests of our
stockholders. Such provisions may have the effect of delaying,
deferring, or preventing a change of control of Cytori and consequently could
adversely affect the market price of our shares. Also, in 2003 we adopted a
Stockholder Rights Plan of the kind often referred to as a poison pill. The
purpose of the Stockholder Rights Plan is to prevent coercive takeover tactics
that may otherwise be utilized in takeover attempts. The existence of such a
rights plan may also prevent or delay a change in control of Cytori, and this
prevention or delay adversely affect the market price of our
shares.
We pay no
dividends
We have
never paid in the past, and currently do not intend to pay any cash dividends in
the foreseeable future.
Substantial sales of shares
may impact the market price of our common stock
Approximately
5.2% of the shares of our common stock outstanding as of May 14, 2009 may be
offered and sold pursuant to this prospectus by the selling stockholders. In
addition, up to 3,263,380
10
additional
shares of our common stock may be offered and sold pursuant to this prospectus
by the selling stockholders upon exercise of warrants issued to them on or about
May 14, 2009. In addition, a majority of the other outstanding shares of our
common stock and substantially all of the shares of our common stock issuable
upon exercise of outstanding stock options and other warrants are eligible for
resale by the holders of those shares pursuant to other effective registration
statements or in exempt private transactions. If our stockholders,
including the selling stockholders listed in this prospectus, sell substantial
amounts of our common stock, the market price of our common stock may decline.
These sales also might make it more difficult for us to sell equity or
equity-related securities in the future at a time and price that we deem
appropriate. We are unable to predict the effect that sales of our common stock
may have on the prevailing market price of our common stock.
11
This
prospectus, including the documents that we incorporate by reference herein,
contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, or the Securities Act, and Section 21E of
the Exchange Act. These statements include, but are not limited to, statements
about our anticipated expenditures, including those related to clinical research
studies and general and administrative expenses, the potential size of the
market for our products, future development and/or expansion of our products and
therapies in our markets, our ability to generate product revenues or
effectively manage our gross profit margins, our ability to obtain regulatory
clearance, expectations as to our future performance, the future impact and
ongoing appeal with respect to our 231 patent litigation, our need for
additional financing and the availability thereof, and the potential enhancement
of our cash position through development, marketing, and licensing arrangements.
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 not always, made through the
use of terminology such as “anticipates,” “believes,” “continue” “estimates,”
“expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” “will,”
or the negative of these terms or other comparable terminology. These
forward-looking statements may also use different phrases. Accordingly, these
statements involve estimates, assumptions and uncertainties that could cause
actual results to differ materially from those expressed in them. Any
forward-looking statement is qualified in its entirety by reference to the
factors discussed in this prospectus, including in the documents incorporated by
reference herein.
Because
the factors discussed in this prospectus, including in the documents
incorporated by reference herein, and even factors of which we are not yet
aware, could cause actual results or outcomes to differ materially from those
expressed in any forward-looking statement made by or on behalf of us, you
should not place undue reliance on any such forward-looking statement. These
statements are subject to risks and uncertainties, known and unknown, which
could cause actual results, performance and achievements to differ materially
from those expressed or implied in such statements. We have included
important factors in the cautionary statements included in this prospectus,
particularly under the heading “Risk Factors,” and in our SEC filings that we
believe could cause actual results or events to differ materially from the
forward-looking statements that we make. These and other risks are also detailed
in our reports filed from time to time under the Securities Act and/or the
Exchange Act. You are encouraged to read these filings as they are
made.
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 to
reflect events or circumstances after the date on which such statement is made
or to reflect the occurrence of unanticipated events. New risk 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.
12
We will
not receive any proceeds from the sale of shares of our common stock by the
selling stockholders. A portion of the shares covered by this
prospectus are issuable upon exercise of warrants to purchase our common stock.
Upon any exercise of the warrants for cash, the selling stockholders would pay
us the exercise price of the warrants. The cash exercise price of the warrants
is $2.62 per share of our common stock, subject to adjustment as set forth in
the warrants. Under certain conditions set forth in the warrants, the warrants
are exercisable on a cashless basis. If the warrants are exercised on a cashless
basis, we would not receive any cash payment from the selling stockholders upon
any exercise of the warrants. Instead, the selling stockholders would satisfy
their obligation to pay the exercise price through a formula-based transfer of
warrant shares to us.
The
selling stockholders will pay any underwriting discounts and commissions and
expenses incurred by the selling stockholders for brokerage, accounting, tax or
legal services or any other expenses incurred by the selling stockholders in
disposing of the shares. We will bear all other costs, fees and expenses
incurred in effecting the registration of the shares covered by this prospectus,
including, without limitation, all registration and filing fees and fees and
expenses of our counsel and our accountants.
13
On May 7,
2009, we entered into a securities purchase agreement with certain institutional
investors named below, pursuant to which we sold an aggregate of 1,864,783
shares of common stock and warrants to purchase an additional 3,263,380 shares
of common stock in private placement transactions otherwise referred to in this
prospectus as the Private Placement. We received aggregate gross proceeds of
approximately $4.25 million in connection with the Private Placement before
deduction of transaction expenses. This prospectus covers the offer and sale by
the selling stockholders listed below of up to 5,128,163 shares, which is the
total number of shares of common stock issued in the Private Placement and
issuable upon exercise of the warrants issued in the Private Placement, in the
manner contemplated under the “Plan of Distribution.”
Pursuant
to the registration rights agreement related to this Private Placement, we
agreed to file a registration statement of which this prospectus is a part with
the Securities and Exchange Commission, or the SEC, to register the disposition
of the shares of our common stock we issued and the shares of common stock we
may issue in the future as a result of exercise of the warrants, and to use our
commercially reasonable efforts to keep the registration statement effective
until the earlier of (a) such time as all of the shares registered
hereunder have been publicly sold by the selling stockholders, and (b) the
date that all of the shares registered hereunder may be sold by non-affiliates
without volume or manner of sale restrictions under Rule 144 under the
Securities Act, without the requirement for the Company to be in compliance with
the current public information requirements under Rule 144.
The
selling stockholders may sell some, all or none of their shares. We do not know
how long the selling stockholders will hold the shares offered hereunder before
selling them. We currently have no agreements, arrangements or understandings
with the selling stockholders regarding the sale of any of the shares by them
other than the registration rights agreement referenced above. The shares
offered by this prospectus may be offered from time to time by the selling
stockholders. As used in this prospectus, the term “selling stockholder”
includes each of the selling stockholders listed below, and any donee, pledgee,
transferee or other successor in interest selling shares received after the date
of this prospectus from a selling stockholder as a gift, pledge, or other
non-sale related transfer. The selling stockholders may have sold or
transferred, in transactions exempt from the registration requirements of the
Securities Act, some or all of their shares since the date on which the
information in the table is presented. Information about the selling
stockholders may change over time.
The
following table sets forth the name of each selling stockholder, the number of
shares owned by such selling stockholder prior to this offering, the number of
shares that may be offered under this prospectus by such selling stockholder,
and the number of shares of our common stock and the percentage (if one percent
or more) of our common stock to be owned by such selling stockholder after
completion of this offering, assuming that all shares offered hereunder are sold
as contemplated herein. The number of shares in the column “Number of Shares
Being Offered” represents all of the shares that a selling stockholder may offer
under this prospectus, which includes the shares issuable upon exercise of the
warrants issued in the Private Placement. Except as otherwise disclosed in this
prospectus (or as disclosed in any document incorporated by reference) including
information incorporated, none of the selling stockholders has, or within the
past three years has had, any position, office or other material relationship
with us. The selling stockholders have advised us that they may enter into short
sales in the ordinary course of their business of investing and trading
securities. The selling stockholders have also advised us that no short sales in
our securities were entered into by them during the period beginning when the
selling stockholders obtained knowledge that we were contemplating a private
placement and ending upon the public announcement of the Private
Placement.
Ownership
reflected in this table for each selling stockholder is based upon information
provided to
14
us by the
selling stockholder and reflects holdings as of May 14, 2009. The percentages of
common stock owned after the offering are based on 35,953,698 shares of our
common stock outstanding as of May 14, 2009 after the closing of the Private
Placement. In computing the number of shares owned by and the
percentage ownership of a selling stockholder, shares of common stock that could
be issued upon the exercise of outstanding options, warrants or other rights
held by that selling stockholder that are currently exercisable or exercisable
within 60 days of May 14, 2009 are considered outstanding. However, such shares
are not included in the shares outstanding as of May 14, 2009 when computing the
percentage ownership of each other selling stockholder.
|
Name
|
Shares
of Common Stock Owned Prior to Offering (1)
|
Maximum
Number of Shares Being Offered
|
Shares
Owned After
Offering (2)
|
|||||
|
Number
|
Percent
|
|||||||
|
Walter
Cruttenden
|
783,070
|
603,070
|
180,000
|
*
|
||||
|
Genet
Family 2007 Opportunity Trust
|
482,458
|
482,458
|
—
|
*
|
||||
|
Thomas
R. Speno & Laura M. Speno
|
512,500
|
412,500
|
100,000
|
*
|
||||
|
Michael
G. Masarek 2008 Grantor Retained Annuity Trust
|
411,843
|
361,843
|
50,000
|
*
|
||||
|
Robert
M. Schneider
|
322,500
|
302,500
|
20,000
|
*
|
||||
|
Gagnon
Investment Associates Master Fund (3)
|
900,017
|
301,535
|
598,482
|
1.66%
|
||||
|
London
Family Trust
|
275,000
|
275,000
|
—
|
*
|
||||
|
M.
Stephen Jackman, as Trustee utd 2/12/96
|
321,858
|
260,478
|
61,380
|
*
|
||||
|
David
Sonenberg
|
301,228
|
241,228
|
60,000
|
*
|
||||
|
Neil
Gagnon (4)
|
532,120
|
180,920
|
351,200
|
*
|
||||
|
David
B. Schulman (5)
|
137,500
|
137,500
|
—
|
*
|
||||
|
Lois
Gagnon (6)
|
350,475
|
120,615
|
229,860
|
*
|
||||
|
Manuel
F. Mair
|
120,615
|
120,615
|
—
|
*
|
||||
|
Perry
Isenberg
|
120,615
|
120,615
|
—
|
*
|
||||
|
Peter
Lacey
|
120,615
|
120,615
|
—
|
*
|
||||
|
Alfred
Sacks
|
90,462
|
90,462
|
—
|
*
|
||||
|
Evan
Brody
|
90,462
|
90,462
|
—
|
*
|
||||
|
Darren
and Tara Levine JTWROS
|
102,500
|
82,500
|
20,000
|
*
|
||||
|
John
Collins
|
98,750
|
68,750
|
30,000
|
*
|
||||
|
Ronald
Henriksen (7)
|
330,377
|
60,500
|
269,877
|
*
|
||||
|
Alan
Rutner
|
63,308
|
60,308
|
3,000
|
*
|
||||
|
Lisa
J. Burley Revocable Trust
|
90,308
|
60,308
|
30,000
|
*
|
||||
|
Randy
M. Bennis
|
85,308
|
60,308
|
25,000
|
*
|
||||
|
Marc
Hedrick (8)
|
896,257
|
55,000
|
841,257
|
2.31%
|
||||
|
Robin
Stricoff
|
55,000
|
55,000
|
—
|
*
|
||||
|
Andrea
Philippou
|
54,277
|
54,277
|
—
|
*
|
||||
|
Angel
Martinez
|
36,185
|
36,185
|
—
|
*
|
||||
|
Gregory
J. Randazza
|
36,185
|
36,185
|
—
|
*
|
||||
|
Bob
& Jeanette Friedman
|
30,250
|
30,250
|
—
|
*
|
||||
|
1999
Garfinkle Family Trust
Marla
Garfinkle, Trustee
|
30,154
|
30,154
|
—
|
*
|
||||
|
Louis
H. Berlin & Nancy H. Berlin JT TEN
|
30,154
|
30,154
|
—
|
*
|
||||
|
Sidney
J. Workman
|
31,154
|
30,154
|
1,000
|
*
|
||||
|
James
Garrett Schwendig, MD, Inc.
|
71,000
|
27,500
|
43,500
|
*
|
||||
|
Kenneth
J. Sobel & Debra S. Sobel,
husband
and wife, as tenants by the entireties
|
24,123
|
24,123
|
—
|
*
|
||||
|
Mike
Reuter
|
24,123
|
24,123
|
—
|
*
|
||||
|
Seitlin
and Company
|
30,625
|
20,625
|
10,000
|
*
|
||||
|
Stanley
R. Brenner
|
13,750
|
13,750
|
—
|
*
|
||||
|
Alan
J. Brenner
|
13,750
|
13,750
|
—
|
*
|
||||
|
Samuel
Katz
|
13,750
|
13,750
|
—
|
*
|
||||
|
Dave
Rickey & Daughters Foundation (9)
|
20,911
|
12,062
|
8,849
|
*
|
||||
|
Solomon
Genet
|
7,746
|
6,031
|
1,715
|
*
|
||||
|
*
|
Indicates
less than one percent
ownership.
|
15
|
(1)
|
The
number of shares presented in this table as owned prior to this offering
includes all shares of common stock issuable upon exercise of the warrants
issued in the Private Placement.
|
|
(2)
|
The
selling stockholders identified in this table may sell some, all, or none
of the shares owned by them that are registered under this registration
statement. While we do not currently have knowledge of any agreements,
arrangements, or understandings with respect to the sale of any of the
shares registered hereunder (other than the registration rights agreement
referenced above), as required for purposes of this table, we are assuming
that the selling stockholders will sell all of the shares indicated in the
table. Percent is based on 35,953,698 shares of common stock
outstanding as of May 14, 2009.
|
|
(3)
|
The
selling stockholder has identified itself as an affiliate of Neil J.
Gagnon, who is the managing member and principal owner of Gagnon
Securities LLC, a registered broker-dealer. The selling stockholder
has represented to us that it purchased the securities sold in the Private
Placement in the ordinary course of its business and at the time of
purchase had no agreement or understanding, directly or indirectly, with
any person regarding distribution of the securities. Mr. Gagnon has
voting and/or investment control over the securities held by the selling
stockholder.
|
|
(4)
|
Mr. Gagnon,
together with certain individuals and entities affiliated with him, has
been a principal stockholder of ours during the past three years.
Mr. Gagnon expressly disclaims beneficial ownership of all securities
held by Gagnon Investment Fund Associates Master
Fund.
|
|
(5)
|
Mr. Schulman has
identified himself as an affiliate of Mass Mutual Investors
Services, a registered broker-dealer. Mr. Schulman has
represented to us that he purchased the securities sold in the
Private Placement in the ordinary course of its business and at the time
of purchase had no agreement or understanding, directly or indirectly,
with any person regarding distribution of the securities.
Mr. Schulman has voting and/or investment control over the securities
held by him.
|
|
(6)
|
Lois
E. Gagnon is the wife of Neil J. Gagnon. Mrs. Gagnon has represented
to us that she purchased the securities sold in the Private Placement in
the ordinary course of business and at the time of purchase had no
agreement or understanding, directly or indirectly, with any person
regarding distribution of the securities. Mr. Gagnon has shared
voting and investment control over the securities held by
Mrs. Gagnon.
|
|
(7)
|
Ronald
Henriksen is Chairman of the Board for Cytori Therapeutics Inc. and has
served as a director since 2002.
|
|
(8)
|
Marc
Hedrick, M.D. is President and a director of Cytori Therapeutics,
Inc.
|
|
(9)
|
Dave
Rickey & Daughters Foundation is affiliated with David Rickey who is a
director of Cytori Therapeutics,
Inc.
|
16
We are registering the shares of common
stock issued to the selling stockholders and shares of common stock issuable
upon exercise of warrants issued to the selling stockholders to permit the
resale of these shares of common stock by the holders of the common stock from
time to time after the date of this prospectus. We will not receive
any of the proceeds from the sale by the selling stockholders of the common
stock. We will bear all fees and expenses incident to our obligation
to register theses shares of common stock.
The
selling stockholders may sell all or a portion of the common stock beneficially
owned by them and offered hereby from time to time directly or through one or
more underwriters, broker-dealers or agents. If the common stock is
sold through underwriters or broker-dealers, the selling stockholders will be
responsible for underwriting discounts or commissions or agent's
commissions. The common stock may be sold on any national securities
exchange or quotation service on which the securities may be listed or quoted at
the time of sale, in the over-the-counter market or in transactions otherwise
than on these exchanges or systems or in the over-the-counter market and in one
or more transactions at fixed prices, at prevailing market prices at the time of
the sale, at varying prices determined at the time of sale, or at negotiated
prices. These sales may be effected in transactions, which may involve crosses
or block transactions. The selling stockholders may use any one or
more of the following methods when selling shares:
|
· ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
|
· block
trades in which the broker-dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to
facilitate the transaction;
|
|
· purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account;
|
|
· an
exchange distribution in accordance with the rules of the applicable
exchange;
|
|
· privately
negotiated transactions;
|
|
· settlement
of short sales entered into after the effective date of the registration
statement of which this prospectus is a
part;
|
|
· broker-dealers
may agree with the selling stockholders to sell a specified number of such
shares at a stipulated price per
share;
|
|
· through
the writing or settlement of options or other hedging transactions,
whether such options are listed on an options exchange or
otherwise;
|
|
· a
combination of any such methods of sale;
and
|
|
· any
other method permitted pursuant to applicable
law.
|
The
selling stockholders also may resell all or a portion of the shares in open
market transactions in reliance upon Rule 144 under the Securities Act, as
permitted by that rule, or Section 4(1) under the
17
Securities
Act, if available, rather than under this prospectus, provided that they meet
the criteria and conform to the requirements of those provisions.
Broker-dealers
engaged by the selling stockholders may arrange for other broker-dealers to
participate in sales. If the selling stockholders effect such transactions by
selling common stock to or through underwriters, broker-dealers or agents, such
underwriters, broker-dealers or agents may receive commissions in the form of
discounts, concessions or commissions from the selling stockholders or
commissions from purchasers of the common stock for whom they may act as agent
or to whom they may sell as principal. Such commissions will be in amounts to be
negotiated, but, except as set forth in a supplement to this prospectus, in the
case of an agency transaction will not be in excess of a customary brokerage
commission in compliance with NASD Rule 2440; and in the case of a principal
transaction a markup or markdown in compliance with NASD IM-2440.
In
connection with sales of the common stock or otherwise, the selling stockholders
may enter into hedging transactions with broker-dealers or other financial
institutions, which may in turn engage in short sales of the common stock in the
course of hedging in positions they assume. The selling stockholders
may also sell common stock short and if such short sale shall take place after
the date that this registration statement is declared effective by the SEC, the
selling stockholders may deliver common stock covered by this prospectus to
close out short positions and to return borrowed shares in connection with such
short sales. The selling stockholders may also loan or pledge common
stock to broker-dealers that in turn may sell such shares, to the extent
permitted by applicable law. The selling stockholders may also enter into option
or other transactions with broker-dealers or other financial institutions or the
creation of one or more derivative securities which require the delivery to such
broker-dealer or other financial institution of shares offered by this
prospectus, which shares such broker-dealer or other financial institution may
resell pursuant to this prospectus (as supplemented or amended to reflect such
transaction). Notwithstanding the foregoing, the selling stockholders have been
advised that they may not use shares registered on this registration statement
to cover short sales of our common stock made prior to the date the registration
statement, of which this prospectus forms a part, has been declared effective by
the SEC.
The
selling stockholders may, from time to time, pledge or grant a security interest
in some or all of the common stock owned by them and, if they default in the
performance of their secured obligations, the pledgees or secured parties may
offer and sell the common stock from time to time pursuant to this prospectus or
any amendment to this prospectus under Rule 424(b)(3) or other applicable
provision of the Securities Act of 1933, as amended, amending, if necessary, the
list of selling stockholders to include the pledgee, transferee or other
successors in interest as selling stockholders under this
prospectus. The selling stockholders also may transfer and donate the
common stock in other circumstances in which case the transferees, donees,
pledgees or other successors in interest will be the selling beneficial owners
for purposes of this prospectus.
The
selling stockholders and any broker-dealer or agents participating in the
distribution of the common stock may be deemed to be “underwriters” within the
meaning of Section 2(11) of the Securities Act in connection with such
sales. In such event, any commissions paid, or any discounts or
concessions allowed to, any such broker-dealer or agent and any profit on the
resale of the shares purchased by them may be deemed to be underwriting
commissions or discounts under the Securities Act. Selling Stockholders who are
"underwriters" within the meaning of Section 2(11) of the Securities Act will be
subject to the applicable prospectus delivery requirements of the Securities Act
and may be subject to certain statutory liabilities of, including but not
limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5
under the Securities Exchange Act of 1934, as amended, or the Exchange
Act.
18
Each
selling stockholder has informed the Company that it is not a registered
broker-dealer and does not have any written or oral agreement or understanding,
directly or indirectly, with any person to distribute the common
stock. Upon the Company being notified in writing by a selling
stockholder that any material arrangement has been entered into with a
broker-dealer for the sale of common stock through a block trade, special
offering, exchange distribution or secondary distribution or a purchase by a
broker or dealer, a supplement to this prospectus will be filed, if required,
pursuant to Rule 424(b) under the Securities Act, disclosing (i) the name of
each such selling stockholder and of the participating broker-dealer(s), (ii)
the number of shares involved, (iii) the price at which such the common stock
was sold, (iv) the commissions paid or discounts or concessions allowed to such
broker-dealer(s), where applicable, (v) that such broker-dealer(s) did not
conduct any investigation to verify the information set out or incorporated by
reference in this prospectus, and (vi) other facts material to the
transaction. In no event shall any broker-dealer receive fees,
commissions and markups, which, in the aggregate, would exceed eight percent
(8%).
Under the
securities laws of some states, the common stock may be sold in such states only
through registered or licensed brokers or dealers. In addition, in
some states the common stock may not be sold unless such shares have been
registered or qualified for sale in such state or an exemption from registration
or qualification is available and is complied with.
There can
be no assurance that any selling stockholder will sell any or all of the common
stock registered pursuant to the shelf registration statement, of which this
prospectus forms a part.
Each
selling stockholder and any other person participating in such distribution will
be subject to applicable provisions of the Securities Exchange Act of 1934, as
amended, and the rules and regulations thereunder, including, without
limitation, to the extent applicable, Regulation M of the Exchange Act, which
may limit the timing of purchases and sales of any of the common stock by the
selling stockholder and any other participating person. To the extent
applicable, Regulation M may also restrict the ability of any person engaged in
the distribution of the common stock to engage in market-making activities with
respect to the common stock. All of the foregoing may affect the
marketability of the common stock and the ability of any person or entity to
engage in market-making activities with respect to the common
stock.
We will
pay all expenses of the registration of the common stock pursuant to the
registration rights agreement, including, without limitation, SEC filing fees
and expenses of compliance with state securities or “blue sky” laws; provided, however, that each selling
stockholder will pay all underwriting discounts and selling commissions, if any
and any related legal expenses incurred by it. We will indemnify the
selling stockholders against certain liabilities, including some liabilities
under the Securities Act, in accordance with the registration rights agreement,
or the selling stockholders will be entitled to contribution. We may
be indemnified by the selling stockholders against civil liabilities, including
liabilities under the Securities Act, that may arise from any written
information furnished to us by the selling stockholders specifically for use in
this prospectus, in accordance with the related registration rights agreements,
or we may be entitled to contribution.
19
The
validity of the issuance of the shares of our common stock offered by this
prospectus will be passed upon for us by DLA Piper LLP (US), San Diego,
California.
The
consolidated financial statements and schedule of Cytori Therapeutics, Inc. as
of December 31, 2008 and 2007, and for each of the years in the three-year
period ended December 31, 2008, and management’s assessment of the effectiveness
of internal control over financial reporting as of December 31, 2008, have been
incorporated by reference herein and in the registration statement in reliance
upon the reports of KPMG LLP, independent registered public accounting firm,
incorporated by reference herein, and upon the authority of said firm as experts
in accounting and auditing.
The audit
report covering the December 31, 2008, consolidated financial statements
contains an explanatory paragraph that states that the Company has suffered
recurring losses from operations and has a net capital deficiency, which raise
substantial doubt about its ability to continue as a going concern. The
consolidated financial statements and the related financial statement schedule
do not include any adjustments that might result from the outcome of that
uncertainty.
We file
annual, quarterly and current reports, proxy statements and other information
electronically with the SEC. You may read and copy these reports, proxy
statements and other information at the SEC’s public reference room at 100 F
Street, N.E., Washington, D.C. 20549 or at the SEC’s other public reference
facilities. Please call the SEC at 1-800-SEC-0330 for more information about the
operation of the public reference room. You can request copies of these
documents by writing to the SEC and paying a fee for the copying costs. The SEC
also maintains an Internet site that contains reports, proxy and information
statements, and other information regarding issuers that file electronically
with the SEC, including us. The SEC’s Internet site can be found at http://www.sec.gov. In
addition, we make available on or through our Internet site copies of these
reports as soon as reasonably practicable after we electronically file or
furnish them to the SEC. Our Internet site can be found at http://www.cytoritx.com.
We are
allowed to incorporate by reference information contained in documents that we
file with the SEC. This means that we can disclose important information to you
by referring you to those documents and that the information in this prospectus
is not complete. You should read the information incorporated by reference for
more detail. We incorporate by reference in two ways. First, we list below
certain documents that we have already filed with the SEC. The information in
these documents is considered part of this prospectus. Second, the information
in documents that we file in the future will update and supersede the current
information in, and incorporated by reference in, this prospectus.
We
incorporate by reference into this prospectus the documents listed below, any
filings we make with the SEC pursuant to Section 13(a), 13(c), 14 or 15(d) of
the Exchange Act after the date of the initial registration statement of which
this prospectus is a part and prior to the effectiveness of the registration
statement, and any filings we make with the SEC pursuant to Section 13(a),
13(c), 14 or 15(d) of the Exchange Act from the date of this prospectus until
the termination of this offering (in each case, except for the information
furnished under Item 2.02 or Item 7.01 in any current report on Form 8-K and
Form 8-K/A):
20
|
·
|
our
annual report on Form 10-K for the year ended December 31, 2008 filed
with the SEC on March 6, 2009 (File No. 000-32501-
09663762);
|
|
·
|
the
information specifically incorporated by reference into our annual report
on Form 10-K for the year ended December 31, 2008 from our definitive
proxy statement on Schedule 14A filed with the SEC on April 30, 2009 (File
No. 000-32501-09783581);
|
|
·
|
our
quarterly report on Form 10-Q for the quarterly period ended March
31, 2009 filed with the SEC on May 11, 2009 (File No. 000-32501-
09814722);
|
|
·
|
our
current report on Form 8-K filed with the SEC on February 2, 2009 (File
No. 000-32501- 09562083);
|
|
·
|
our
current report on Form 8-K filed with the SEC on March 10, 2009 (File No.
000-32501- 09667881);
|
|
·
|
our
current report on Form 8-K filed with the SEC on May 6, 2009 (File No.
000-32501- 09802677);
|
|
·
|
our
current report on Form 8-K filed with the SEC on May 8, 2009 (File No.
000-32501- 09807196);
|
|
·
|
the
description of our common stock contained in our registration statement on
Form 10/A filed with the SEC on July 16, 2001 (File No.
000-32501-1682501); and
|
|
·
|
the
description of our Series RP Preferred Stock Purchase Rights contained in
our registration statement on Form 8-A filed with the SEC on May 30, 2003
(File No. 000-32501-03725608), including any amendments or reports filed
for the purpose of updating the
description.
|
|
·
|
the
description of our warrants contained in our registration statement on
Form 8-A filed with the SEC on June 8, 2009 (File No. 001-34375-09878357),
including any amendments or reports filed for the purpose of
updating the description.
|
We will
provide each person, including any beneficial owner, to whom a prospectus is
delivered, a copy of any or all of the information that has been incorporated by
reference into this prospectus but not delivered with this prospectus upon
written or oral request at no cost to the requester. Requests should be directed
to: Cytori Therapeutics, Inc., 3020 Callan Road, San Diego, CA 92121, Attn:
Investor Relations, telephone: (858) 458-0900.
This
prospectus is part of a registration statement that we filed with the SEC. The
registration statement contains more information than this prospectus regarding
us and our common stock, including certain exhibits and schedules. You can
obtain a copy of the registration statement from the SEC at the address listed
above or from the SEC’s Internet website.
You
should rely only on the information provided in and incorporated by reference
into this prospectus or any prospectus supplement. We have not authorized anyone
else to provide you with different information. You should not assume that the
information in this prospectus or any prospectus supplement is accurate as of
any date other than the date on the front cover of these documents.
21
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses
of Issuance and Distribution.
The
following sets forth the estimated costs and expenses, all of which shall be
borne by the registrant, in connection with the offering of the securities
pursuant to this registration statement:
|
Registration
fee
|
$ | 1,262 | |||
|
Legal
fees and expenses
|
$ | 10,000 | |||
|
Accounting
fees
|
$ | 9,500 | |||
|
Printing
expenses
|
$ | 5,000 | |||
|
Miscellaneous
expenses
|
$ | 1,238 | |||
|
Total
|
$ | 27,000 | |||
Item
15. Indemnification
of Officers and Directors.
Section
145 of the Delaware General Corporation Law authorizes a court to award or a
corporation’s board of directors to grant indemnification to directors and
officers in terms sufficiently broad to permit such indemnification under
certain circumstances for liabilities (including reimbursement for expenses
incurred) arising under the Securities Act.
Our
amended and restated certificate of incorporation, or our Certificate, includes
a provision that, to the fullest extent permitted by the Delaware General
Corporation Law, eliminates the personal liability of our directors for monetary
damages for breach of fiduciary duty as a director. In addition, together our
Certificate and our bylaws, as amended, require us to indemnify, to the fullest
extent permitted by law, any person made or threatened to be made a party to an
action or proceeding (whether criminal, civil, administrative or investigative)
by reason of the fact that such person is or was a director, officer or employee
of Cytori or any predecessor of ours, or serves or served at any other
enterprise as a director, officer or employee at our request or the request of
any predecessor of ours, against expenses (including attorneys’ fees),
judgments, fines, settlements and other amounts actually and reasonably incurred
in connection with any proceeding, arising by reason of the fact that such
person is or was an agent of ours. Our bylaws also provide that we may, to the
fullest extent provided by law, indemnify any person against expenses (including
attorneys’ fees), judgments, fines, settlements and other amounts actually and
reasonably incurred in connection with any proceeding, arising by reason of the
fact that such person is or was an agent of ours. We are required to advance
expenses incurred by our directors, officers, employees and agents in defending
any action or proceeding for which indemnification is required or permitted,
subject to certain limited exceptions. The indemnification rights conferred by
our bylaws are not exclusive.
We have
obtained directors and officers liability insurance.
II-1
Item
16. Exhibits.
|
Exhibit
Number
|
Description
|
|
|
2.5
|
Asset
Purchase Agreement dated May 30, 2007, by and between Cytori
Therapeutics, Inc. and MacroPore Acquisition Sub, Inc (filed as
Exhibit 2.5 to our Form 10-Q Quarterly Report as filed on August
14, 2007 (File No. 000-32501-071054007) and incorporated by reference
herein)
|
|
|
3.1
|
Amended
and Restated Certificate of Incorporation (filed as Exhibit 3.1
to our Form 10-Q Quarterly Report as filed on August 13, 2002 (File
No. 000-32501-02727729) and incorporated by reference
herein)
|
|
|
3.2
|
Amended
and Restated Bylaws of Cytori Therapeutics, Inc. (filed as
Exhibit 3.2 to our Form 10-Q Quarterly Report, as filed on
August 14, 2003 (File No. 000-32501-03844770) and incorporated by
reference herein)
|
|
|
3.3
|
Certificate
of Ownership and Merger (effecting name change to Cytori Therapeutics,
Inc.) (filed as Exhibit 3.1.1 to our Form 10-Q, as filed on November 14,
2005 (File No. 000-32501-051202324) and incorporated by reference
herein)
|
|
|
4.1
|
Rights
Agreement, dated as of May 19, 2003, between Cytori Therapeutics, Inc. and
Computershare Trust Company, Inc. as Rights Agent, which includes: as
Exhibit A thereto, the Form of Certificate of Designation, Preferences and
Rights of Series RP Preferred Stock of Cytori Therapeutics, Inc.; as
Exhibit B thereto, the Form of Right Certificate; and, as Exhibit C
thereto, the Summary of Rights to Purchase Series RP Preferred Stock
(filed as Exhibit 4.1 to our Form 8-A which was filed on May 30, 2003
(File No. 000-32501-03725608) and incorporated by reference
herein)
|
|
|
4.1.1
|
Amendment
No. 1 to Rights Agreement dated as of May 12, 2005, between Cytori
Therapeutics, Inc. and Computershare Trust Company, Inc. as Rights Agent
(filed as Exhibit 4.1.1 to our Form 8-K, which was filed on May 18, 2005
(File No. 000-32501-05842203) and incorporated by reference
herein).
|
|
|
4.1.2
|
Amendment
No. 2 to Rights Agreement, dated as of August 28, 2007, between us and
Computershare Trust Company, N.A. (as successor to Computershare Trust
Company, Inc.), as Rights Agent (filed as Exhibit 4.1.1 to our Form 8-K,
which was filed on September 4, 2007 (File No. 000-32501-071096673) and
incorporated by reference herein).
|
|
|
5.1*
|
Opinion
of DLA Piper LLP (US)
|
|
|
10.63
|
Securities
Purchase Agreement, dated May 7, 2009, by and among Cytori Therapeutics,
Inc. and the purchasers identified on the signature pages thereto (filed
as Exhibit 10.63 to our Form 8-K, which was filed on May 8, 2009 (File No.
000-32501-09802677)
|
|
|
10.64
|
Form
of Warrant to Purchase Common Stock issued on or about May 14, 2009 (filed
as Exhibit 10.64 to our Form 8-K, which was filed on May 8, 2009 (File No.
000-32501-09802677) and incorporated by reference
herein).
|
|
|
10.65
|
Registration
Rights Agreement, dated May 7, 2009, by and among Cytori Therapeutics,
Inc. and the purchasers listed on the signature pages thereto (filed as
Exhibit 10.65 to our Form 8-K, which was filed on May 8, 2009 (File No.
000-32501-09802677) and incorporated by reference
herein).
|
|
|
23.1*
|
Consent
of KPMG LLP
|
|
|
23.2*
|
Consent
of DLA Piper LLP (US) (included in Exhibit 5.1).
|
|
|
24.1*
|
Power
of attorney (included on the signature page to the registration
statement).
|
|
* Filed
herewith
II-2
Item
17. Undertakings.
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;
(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 SEC
pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than a 20% change in the maximum aggregate offering price set
forth in the “Calculation of Registration Fee” table in the effective
registration statement; 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;
Provided, however, that
paragraphs (1)(i), (1)(ii) and (1)(iii) do not apply if the registration
statement is on Form S-3 or Form F-3, and the information required to be
included in a post-effective amendment by those paragraphs is contained in
reports filed with or furnished to the SEC by the registrant pursuant to Section
13 or Section 15(d) of the Exchange Act that are incorporated by reference in
the registration statement or is contained in a form of prospectus filed
pursuant to Rule 424(b) that is part of the registration statement.
(2) That,
for the purpose of determining any liability under the Securities Act, each
post-effective amendment that contains a form of prospectus 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 this
offering.
(4) That,
for the purpose of determining liability under the Securities Act to any
purchaser:
II-3
(i) If
the registrant is relying on Rule 430B:
(A) Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to
be part of the registration statement as of the date the filed prospectus was
deemed part of and included in the registration statement; and
(B) Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as
part of a registration statement in reliance on Rule 430B relating to an
offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of
providing the information required by section 10(a) of the Securities Act shall
be deemed to be part of and included in the registration statement as of the
earlier of the date such form of prospectus is first used after effectiveness or
the date of the first contract of sale of securities in the offering described
in the prospectus. As provided in Rule 430B, for liability purposes of the
issuer and any person that is at that date an underwriter, such date shall be
deemed to be a new effective date of the registration statement relating to the
securities in the registration statement to which that prospectus relates, and
the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof. 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 effective date, 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 effective date;
or
(ii) If
the registrant is subject to Rule 430C, 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 field 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.
The
undersigned registrant hereby undertakes that, for purposes of determining any
liability under the Securities Act, each filing of the registrant’s annual
report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where
applicable, each filing of an employee benefit plan’s annual report pursuant to
Section 15(d) of the Exchange Act) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona
fide offering thereof.
Insofar
as indemnification for liabilities arising under the Securities Act 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 SEC this form of indemnification is against
public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against these
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 a 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 Securities Act and will be governed by the final
adjudication of this issue.
II-4
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that
it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-3 and has duly caused this registration statement to be signed
on its behalf by the undersigned, thereunto duly authorized in the City of San
Diego, State of California, on June 11, 2009.
CYTORI
THERAPEUTICS, INC.
By: /s/ Christopher J.
Calhoun_________________
Christopher J. Calhoun
Chief Executive Officer
II-5
POWER
OF ATTORNEY
KNOW ALL
PERSONS BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints Christopher J. Calhoun and Mark E. Saad, and each of
them acting individually, as his or her true and lawful attorneys-in-fact and
agent, with full power of each to act alone, with full powers of substitution
and resubstitution, for him or her and in his or her name, place and stead, in
any and all capacities, to sign any and all amendments to this registration
statement (including post-effective amendments and any related registration
statements filed pursuant to Rule 462 and otherwise), and to file the same with
all exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorneys-in-fact and
agents, and full power and authority to do and perform each and every act and
thing requisite and necessary to be done in connection therewith, as fully for
all intents and purposes as he or she might or could do in person, hereby
ratifying and confirming that all said attorneys-in-fact and agents, or any of
them or their substitute or resubstitute, may lawfully do or cause to be done by
virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, as amended, this registration
statement has been signed by the following persons in the capacities and on the
dates indicated.
|
SIGNATURE
|
TITLE
|
DATE
|
|
/s/
Ronald D. Henriksen
|
Chairman
of the Board of Directors
|
June
11, 2009
|
|
Ronald
D. Henriksen
|
||
|
/s/
Christopher J. Calhoun
|
Chief
Executive Officer, Vice-Chairman, Director
|
June
11, 2009
|
|
Christopher
J. Calhoun
|
(Principal
Executive Officer)
|
|
|
/s/
Marc H. Hedrick, MD
|
President,
Director
|
June
11, 2009
|
|
Marc
H. Hedrick, MD
|
||
|
/s/
Mark E. Saad
|
Chief
Financial Officer (Principal Financial Officer)
|
June
11, 2009
|
|
Mark
E. Saad
|
||
|
/s/
John W. Townsend
|
Chief
Accounting Officer (Principal Accounting Officer)
|
June
11, 2009
|
|
John
W. Townsend
|
|
|
|
/s/
Richard J. Hawkins
|
Director
|
June
11, 2009
|
|
Richard
J. Hawkins
|
||
|
/s/
Paul W. Hawran
|
Director
|
June
11, 2009
|
|
Paul
W. Hawran
|
||
|
/s/
E. Carmack Holmes, MD
|
Director
|
June
11, 2009
|
|
E.
Carmack Holmes, MD
|
||
|
/s/
David M. Rickey
|
Director
|
June
11, 2009
|
|
David
M. Rickey
|
II-6
EXHIBIT
INDEX
|
Exhibit
Number
|
Description
|
|
|
2.5
|
Asset
Purchase Agreement dated May 30, 2007, by and between Cytori
Therapeutics, Inc. and MacroPore Acquisition Sub, Inc (filed as
Exhibit 2.5 to our Form 10-Q Quarterly Report as filed on August
14, 2007 (File No. 000-32501-071054007) and incorporated by reference
herein)
|
|
|
3.1
|
Amended
and Restated Certificate of Incorporation (filed as Exhibit 3.1
to our Form 10-Q Quarterly Report as filed on August 13, 2002 (File
No. 000-32501-02727729) and incorporated by reference
herein)
|
|
|
3.2
|
Amended
and Restated Bylaws of Cytori Therapeutics, Inc. (filed as
Exhibit 3.2 to our Form 10-Q Quarterly Report, as filed on
August 14, 2003 (File No. 000-32501-03844770) and incorporated by
reference herein)
|
|
|
3.3
|
Certificate
of Ownership and Merger (effecting name change to Cytori Therapeutics,
Inc.) (filed as Exhibit 3.1.1 to our Form 10-Q, as filed on November 14,
2005 (File No. 000-32501-051202324) and incorporated by reference
herein)
|
|
|
4.1
|
Rights
Agreement, dated as of May 19, 2003, between Cytori Therapeutics, Inc. and
Computershare Trust Company, Inc. as Rights Agent, which includes: as
Exhibit A thereto, the Form of Certificate of Designation, Preferences and
Rights of Series RP Preferred Stock of Cytori Therapeutics, Inc.; as
Exhibit B thereto, the Form of Right Certificate; and, as Exhibit C
thereto, the Summary of Rights to Purchase Series RP Preferred Stock
(filed as Exhibit 4.1 to our Form 8-A which was filed on May 30, 2003
(File No. 000-32501-03725608) and incorporated by reference
herein)
|
|
|
4.1.1
|
Amendment
No. 1 to Rights Agreement dated as of May 12, 2005, between Cytori
Therapeutics, Inc. and Computershare Trust Company, Inc. as Rights Agent
(filed as Exhibit 4.1.1 to our Form 8-K, which was filed on May 18, 2005
(File No. 000-32501-05842203) and incorporated by reference
herein).
|
|
|
4.1.2
|
Amendment
No. 2 to Rights Agreement, dated as of August 28, 2007, between us and
Computershare Trust Company, N.A. (as successor to Computershare Trust
Company, Inc.), as Rights Agent (filed as Exhibit 4.1.1 to our Form 8-K,
which was filed on September 4, 2007 (File No. 000-32501-071096673) and
incorporated by reference herein).
|
|
|
5.1*
|
Opinion
of DLA Piper LLP (US)
|
|
|
10.63
|
Securities
Purchase Agreement, dated May 7, 2009, by and among Cytori Therapeutics,
Inc. and the purchasers identified on the signature pages thereto (filed
as Exhibit 10.63 to our Form 8-K, which was filed on May 8, 2009 (File No.
000-32501-09802677)
|
|
|
10.64
|
Form
of Warrant to Purchase Common Stock issued on or about May 14, 2009 (filed
as Exhibit 10.64 to our Form 8-K, which was filed on May 8, 2009 (File No.
000-32501-09802677) and incorporated by reference
herein).
|
|
|
10.65
|
Registration
Rights Agreement, dated May 7, 2009, by and among Cytori Therapeutics,
Inc. and the purchasers listed on the signature pages thereto (filed as
Exhibit 10.65 to our Form 8-K, which was filed on May 8, 2009 (File No.
000-32501-09802677) and incorporated by reference
herein).
|
|
|
23.1*
|
Consent
of KPMG LLP
|
|
|
23.2*
|
Consent
of DLA Piper LLP (US) (included in Exhibit 5.1).
|
|
|
24.1*
|
Power
of attorney (included on the signature page to the registration
statement).
|
|
* Filed
herewith
Exhibit
5.1
|
DLA
Piper LLP (US)
4365
Executive Drive, Suite 1100
San
Diego, California 92121-2133
www.dlapiper.com
|
|
|
T 858.677.1400
F 858.677.1401
|
|
|
June
11, 2009
|
Cytori
Therapeutics, Inc.
3020
Callan Road
San
Diego, CA 92121
Ladies
and Gentlemen:
We have
acted as counsel to Cytori Therapeutics, Inc., a Delaware corporation (the
“Company”),
in connection with the filing on the date hereof of a registration statement on
Form S-3 (the “Registration
Statement”) under the Securities Act of 1933, as amended (the “Securities
Act”). The Registration Statement relates to the registration of a total of
5,128,163 shares of the Company’s common
stock, par value $0.001 per share (the “Shares”), for resale by the
stockholders identified in the Registration Statement, (i) 1,864,783 of which are issued and
outstanding and (ii) up to 3,263,380 of which are issuable by the Company upon
the exercise of outstanding warrants (the “Warrant
Shares”).
We have
examined all instruments, documents and records which we deemed relevant and
necessary for the basis of our opinion hereinafter expressed. In such
examination, we have assumed the genuineness of all signatures and the
authenticity of all documents submitted to us as originals and the conformity to
the originals of all documents submitted to us as copies. We express
no opinion concerning any law other than the corporation law of the State of
Delaware and the federal law of the United States. As to matters of
Delaware corporation law, we have based our opinion solely upon our examination
of such laws and the rules and regulations of the authorities administering such
laws, all as reported in standard, unofficial compilations.
Based on
such examination, we are of the opinion that the Shares (excluding the Warrant
Shares) have been validly issued and are fully paid and nonassessable and, if,
as and when the Warrant Shares are issued and delivered by the Company pursuant
to the terms of each warrant, including, without limitation, payment in full of
the applicable consideration, the Warrant Shares will be validly issued, fully
paid and nonassessable.
We hereby
consent to the filing of this opinion as an exhibit to the Registration
Statement and the reference to us under the caption “Legal Matters” in the
prospectus included in the Registration Statement. In giving this
consent, we do not admit that we are within the category of persons whose
consent is required under Section 7 of the Securities Act or the rules and
regulations of the Securities and Exchange Commission promulgated
thereunder.
1
This
opinion letter is given to you solely for use in connection with the
registration for resale of the Shares in accordance with the prospectus included
in the Registration Statement and is not to be relied upon for any other
purpose. Our opinion is expressly limited to the matters set forth
above, and we render no opinion, whether by implication or otherwise, as to any
other matters relating to the Company, the Shares or the Registration
Statement.
Very
truly yours,
|
/s/ DLA Piper LLP (US)
|
|
|
DLA
Piper LLP (US)
|
2
Exhibit
23.1
Consent
of Independent Registered Public Accounting Firm
The Board
of Directors
Cytori
Therapeutics, Inc:
We
consent to the use of our reports dated March 6, 2009, with respect to the
consolidated balance sheets of Cytori Therapeutics, Inc. and subsidiaries as of
December 31, 2008 and 2007, the related consolidated statements of operations
and comprehensive loss, stockholders’ equity (deficit), and cash flows for each
of the years in the three-year period ended December 31, 2008, and the related
financial statement schedule, and the effectiveness of internal control over
financial reporting of Cytori Therapeutics, Inc. as of December 31, 2008,
incorporated by reference herein and to the reference to our firm under the
heading “Experts” in the prospectus.
Our
report on the consolidated financial statements dated March 6, 2009, contains an
explanatory paragraph that states that the Company has suffered recurring losses
from operations and has a net capital deficiency, which raise substantial doubt
about its ability to continue as a going concern. The consolidated financial
statements and the related financial statement schedule do not include any
adjustments that might result from the outcome of that uncertainty.
|
/s/
KPMG LLP
|
|
San
Diego, California
June
10, 2009
|