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EX-5.1 - Nuo Therapeutics, Inc. | v204570_ex5-1.htm |
As filed with the Securities and Exchange Commission on December 6, 2010 |
Registration No.
333-170747
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
Pre-Effective Amendment No.1
to
FORM
S-1
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
CYTOMEDIX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
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3841
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23-3011702
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(State
or other jurisdiction of incorporation or
organization)
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(Primary
Standard Industrial
Classification
Code Number)
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(I.R.S.
Employer Identification
Number)
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209
Perry Parkway, Suite 7
Gaithersburg,
MD 20877
(240)
499-2680
(Address,
including zip code, and telephone number, including
area
code, of registrant’s principal executive offices)
Martin
P. Rosendale
Chief
Executive Officer
209
Perry Parkway, Suite 7
Gaithersburg,
MD 20877
(240)
499-2680
(Name,
address, including zip code, and telephone number,
including
area code, of agent for service)
Copies
to:
Ralph
V. DeMartino, Esq.
F.
Alec Orudjev, Esq.
Cozen
O’Connor
1627
I Street, NW, Suite 1100
Washington,
DC 20006
Telephone:
(202) 912-4800
Facsimile:
(202) 912-4830
APPROXIMATE DATE OF COMMENCEMENT OF
PROPOSED SALE TO THE PUBLIC: From time to time after the effective date
of this registration statement, as determined by the Selling
Stockholder.
If any of
the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the
following box. x
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 post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer”,
“accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the
Exchange Act (Check one):
Large
accelerated filer
|
¨
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Accelerated
filer
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¨
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Non-accelerated
filer
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¨
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Smaller
reporting company
|
x
|
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 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
This
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.
Subject
to Completion, dated December 6, 2010
PROSPECTUS
CYTOMEDIX,
INC.
12,336,538
Shares of Common Stock
This
prospectus relates to the resale of up to 12,336,538 shares of common stock of
Cytomedix, Inc. by Lincoln Park Capital Fund, LLC. Lincoln Park
Capital Fund, LLC is sometimes referred to in this prospectus as “Selling
Stockholder” or “Lincoln Park.” The common stock being offered by
Lincoln Park is issuable pursuant to a purchase agreement between us and Lincoln
Park. The prices at which Lincoln Park may sell the shares will be determined by
the prevailing market price for the shares. We do not know when or in
what amounts Lincoln Park may offer the shares for sale. We will not
receive proceeds from the sale of our shares by Lincoln Park.
Our
common stock is presently listed on the NYSE Amex LLC under the symbol
“GTF.BC”. On November 12, 2010, the last sales price of the common
stock, as reported on the NYSE Amex was $0.51 per share.
The
Selling Stockholder is an “underwriter” within the meaning of the Securities Act
of 1933, as amended.
Investing
in our common stock is highly speculative and involves a high degree of risk.
You should purchase these securities only if you can afford a complete loss of
your investment. You should carefully consider the risks and
uncertainties described under the heading "Risk Factors" beginning on page 4 of
this prospectus before making a decision to purchase our common
stock.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of
these securities or passed upon the accuracy or adequacy of this prospectus. Any
representation to the contrary is a criminal offense.
The
date of this prospectus
is
, 2010
TITLE
OF CONTENTS
Page
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PROSPECTUS SUMMARY
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1
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RISK FACTORS
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5
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FORWARD-LOOKING STATEMENTS
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15
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USE OF PROCEEDS
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16
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MARKET PRICE OF OUR COMMON STOCK AND RELATED
STOCKHOLDER MATTERS
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17
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DILUTION
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18
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SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
AND MANAGEMENT
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19
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SELLING SECURITY HOLDER
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21
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PLAN OF DISTRIBUTION
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22
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DESCRIPTION OF SECURITIES
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23
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THE TRANSACTION
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24
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INCORPORATION BY REFERENCE
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27
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LEGAL MATTERS
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28
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EXPERTS
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28
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WHERE YOU CAN FIND MORE
INFORMATION
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28
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No
offers to sell are made, nor are offers sought, to buy these securities in any
jurisdiction where the offer or sale is not permitted. The reader
should assume that the information contained in this prospectus is accurate as
of the date in front of this prospectus only. Our business, financial
condition, results of operations, and prospectus may have changed since that
date.
PROSPECTUS
SUMMARY
This summary highlights information
set forth in greater detail elsewhere in this prospectus. It may not contain all
the information that may be important to you. You should read this entire
prospectus carefully, including the sections entitled "Risk Factors" beginning
on page 4 and our historical financial statements and related notes incorporated
by reference into this prospectus. Unless the context requires otherwise,
references to the “Company,” “Cytomedix,” “we,” “our,” and “us,” refer to
Cytomedix, Inc. and its subsidiaries.
You
should rely only on the information contained in this prospectus or any related
prospectus
Our
Company
We are a
biotechnology company that develops, sells, and licenses regenerative biological
therapies to primarily address the areas of wound care, inflammation, and
angiogenesis. We currently market the AutoloGel™ System, a device for the
production of autologous platelet rich plasma gel. The AutoloGel System is
cleared by the United States Food and Drug Administration for use on a variety
of exuding wounds. We are currently pursuing a multi-faceted strategy to
penetrate the chronic wound market with our AutoloGel System. We are also
pursuing opportunities for the application of AutoloGel and PRP technology into
other markets such as hair transplantation and orthopedics, as well as actively
seeking complementary products for the wound care market. We sell our products
primarily to health care providers in the United States and have modest
distribution arrangements in Europe and Canada.
In April
2010, we acquired the Angel® Whole Blood Separation System and ActivAT®
Autologous Thrombin Processing Kit from Sorin Group USA, Inc. Used primarily in
surgical settings, Angel is used for separation of whole blood into red cells,
platelet poor plasma and PRP. ActivAT is designed to produce autologous thrombin
serum from platelet poor plasma and is sold exclusively in Europe and Canada,
where it provides a completely autologous, safe alternative to bovine-derived
products. The Angel System, which received market clearance from the FDA in
August 2005, consists of a blood processing device and disposable products used
for separation of whole blood into red blood cells, platelet poor plasma and
PRP. We expect that sales growth of these products will be driven through a
combination of strengthened distributor relationships, collaborative agreements,
and direct sales. We expect commercial synergies with AutoloGel will increase
sales efficiency and help drive growth. Sales growth outside of the U.S. will be
managed through distributor agreements.
Our
Contact Information
Our
corporate headquarters are located at 209 Perry Parkway, Suite 7, Gaithersburg,
MD 20877. Our telephone number is (240) 499-2680 and our website is located at
http://www.cytomedix.com. The
information on our website is not a part of this prospectus.
Recent
Developments
Sorin
Asset Acquisition and Private Placement
On April
9, 2010, we, through our wholly-owned subsidiary, Cytomedix Acquisition Company,
LLC, entered into an Asset Purchase Agreement with Sorin Group USA, Inc., a
Delaware corporation, or Seller, to buy all title and interest in certain assets
of and assume certain liabilities in Seller’s operation of the Angel systems
(including the whole blood separation system, the blood processing kit and blood
accessing kit) and ActivAT businesses. Angel is a device that utilizes validated
blood separation technology to separate platelets and plasma from other
components of a patient’s blood. The device provides the necessary flexibility
and sophistication for more complex clinical situations. The ActivAT technology
facilitates the preparation of autologous human thrombin and currently is sold
exclusively in Europe and Canada. We believe that the Angel and ActivAT
technologies acquired from the Sorin Group will provide us with immediate access
to surgical and orthopedic markets. By acquiring Angel, we became the only
supplier of PRP technology with the FDA cleared indications for both topical use
in wound care and surgical use. Under the terms of the agreement, we agreed to
pay to the Seller an aggregate amount equal to $7 million, payable as follows:
(i) $2 million paid on April 9, 2010, the closing date of transaction, and (ii)
$5 million to be paid under the terms of a promissory note in principal amount
of $5 million with interest accruing at 2.7% per annum. We also entered into
several side agreements, including Transition Agreements, Asset Transfer and
Assumption Agreements, to facilitate the transition and these transactions. This
acquisition closed on April 9, 2010.
1
On April
9, 2010, we entered into subscription agreements with certain accredited
investors, with respect to the sale of (i) 10% Series D Convertible Preferred
Stock, and (ii) warrants to purchase shares of common stock of the Company, for
gross proceeds of $3.65 million, $2.0 million of which was used to pay the
initial purchase price in connection with the Sorin acquisition and the balance
to be used for general corporate and working capital purposes. The investors in
the April 2010 Offering were also issued five-year warrants to purchase, in the
aggregate, 4,128,631 shares of common stock, or 50% of the shares of common
stock underlying the Series D Convertible Preferred Stock in the April 2010
Offering, at an exercise price per share of $0.5368. Each Warrant was
exercisable immediately on the date of issuance and will expire on April 9,
2015.
For
accounting purposes, the Series D Convertible Preferred Stock in connection with
the April 2010 Offering was recorded in shareholders’ equity on our balance
sheet. Common stock, if and when issued upon exercises of the Warrants in the
same offering, will also be recorded in shareholders’ equity and the cash
proceeds of such warrant exercises, to the extent we receive such proceeds, will
be used for general corporate and working capital purposes, as we may deem
appropriate.
NYSE
Amex Compliance
On
November 15, 2010, NYSE Amex LLC (the "Exchange") notified us that the Exchange
intended to strike the listing of the Company's securities from the Exchange
pursuant to Section 1009(d) of the NYSE Amex LLC Company Guide. The
staff letter also informed the Company that it had the right to appeal the Staff
Determination. The Company requested and obtained an oral
hearing before a Listing Qualifications Panel of the Exchange (the "Panel").
Pending such appeal and the Panel's determination, the Company's securities will
remain listed on the Exchange. There can be no assurance that the Panel will
grant the Company's request for continued listing. If the Panel does not grant
the relief sought by the Company, its securities will be delisted from the
Exchange in which event the Company would seek to cause them be quoted on the
OTC Bulletin Board ("OTC-BB"). Management anticipates that although quotation of
Company securities on the OTC-BB may result in a less liquid market for the
securities, public trading of Company securities would continue without
interruption by holders desiring to trade.
October
2010 Registered Direct Offering
On
October 7, 2010, we entered into securities purchase agreements with investors
to raise gross proceeds of approximately $1.5 million, before offering related
fees and expenses, in a registered direct offering of units consisting of shares
and warrants. We issued an aggregate of 3,727,677 shares of our
common stock and warrants to purchase 1,863,839 shares of common stock. The
purchase price paid by investors was $0.40 for each unit and the unit purchase
price paid by affiliate investors was $0.53. The warrants expire after five
years and are exercisable at $0.60 per share on or after April 7, 2011. Proceeds
from that offering were used to service our initial scheduled payment obligation
under the Sorin promissory note and for general corporate and working capital
purposes. The offering was made pursuant to a shelf registration statement on
(SEC File No. 333-147793, the base prospectus originally filed with the SEC on
December 3, 2007), as supplemented by a prospectus supplement filed with the SEC
on October 8, 2010.
2
Lincoln
Park Transaction
On
October 6, 2010, we entered into a certain Purchase Agreement (the “LPA”) with
Lincoln Park, which provides that, upon the terms and subject to the conditions
and limitations set forth therein, Lincoln Park is committed to purchase up to
an aggregate of $1.5 million of the Company’s shares of common stock, including
91,784 commitment shares, over the 25-month term of the LPA. Under this LPA, the
Company has the right, in its sole discretion, on every other business day, to
present Lincoln Park with a purchase notice, directing Lincoln Park (as
principal) to purchase up to 150,000 shares of the Company’s common stock per
trading day, up to $1.5 million of the Company’s common stock in the aggregate
over the 25-month term of the LPA, at a per share price (the “Purchase Price”)
calculated as the lower of (i) the lowest trading price on the date of sale or
(ii) the arithmetic average of the three lowest closing sale prices for the
common stock during the 12 consecutive business days ending on the business day
immediately preceding the purchase date of those securities. The LPA provides in
no event shall the Purchase Price be less than $0.30 per share. The
Company will control the timing and amount of any sales of its common stock to
Lincoln Park. Lincoln Park has no right to require any sales by the Company, but
is obligated to make purchases from the Company as the Company directs in
accordance with the LPA. The Company also can accelerate the amount of common
stock to be purchased under certain circumstances. There are no limitations on
use of proceeds, financial or business covenants, restrictions on future
funding, rights of first refusal, participation rights, penalties or liquidated
damages in the LPA. The Company did not pay any expense reimbursement or
placement agent fee in connection with the LPA. The LPA may be
terminated by the Company at any time, at its discretion, without any penalty or
cost to the Company. The Company’s ability to sell its shares to
Lincoln Park is also subject to its obtaining all necessary consents, amendments
or waivers as may be required. Under the LPA, the Company may not
sell to Lincoln Park any shares of its common stock in excess of 19.99% of its
shares of common stock outstanding, unless and until such issuances are approved
by our shareholders, in the event such approval is required under the rules and
regulations of the trading market where the Company’s securities are then
listed. The offering was made pursuant to a shelf registration
statement on (SEC File No. 333-147793, the base prospectus originally filed with
the SEC on December 3, 2007), as supplemented by a prospectus supplement filed
with the SEC on October 8, 2010. The net proceeds the Company may
receive will depend on the frequency and prices at which it sells shares of
stock to Lincoln Park under the LPA and the maximum proceeds it may receive over
the 25-month term of the agreement is $1.5 million. The Company
expects that any proceeds received by the Company from sales of the Company’s
common stock to Lincoln Park under the LPA, when such sales are made, will be
used for debt service, general corporate and working capital
purposes.
Securities
Offered
Common
stock currently outstanding
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42,382,311
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Common
stock offered by Selling Stockholder:
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12,336,538 shares
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Use
of proceeds:
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Lincoln
Park will receive all net proceeds from sale by Lincoln Park of our common
stock covered by this prospectus. We will not receive any proceeds from
any such sale. See “Use of Proceeds” on page
14.
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Risk
Factors
|
See
“Risk Factors” beginning on page 4 and other information included in this
prospectus for a discussion of factors you should carefully consider
before deciding to invest in the shares.
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NYSE
Amex Ticker Symbol:
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GTF.BC
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3
This
Offering
On
October 5, 2010, we executed a purchase agreement, as amended to date (“Purchase
Agreement”), and a registration rights agreement (“Registration Rights
Agreement”), with Lincoln Park. Under the Purchase Agreement, Lincoln
Park has agreed to purchase up to $10 million of our common stock, from time to
time over a 25-month period. Pursuant to the Registration Rights
Agreement, we filed a registration statement, of which this prospectus is a
part, with the SEC covering the shares that may be issued to Lincoln Park under
the Purchase Agreement. Upon the effectiveness of the registration
statement, we have the right, but not the obligation, over a 25-month period, to
sell our common stock to Lincoln Park in amounts up to 150,000 shares every
other business day, depending on certain condition as set forth in the Purchase
Agreement, up to an aggregate amount of $10 million. In consideration
for entering into the Purchase Agreement, the Company issued to Lincoln Park
305,944 shares of restricted common stock as an initial commitment and is
required to issue up to 336,538 shares of common stock pro rata as additional
commitment shares as the Company requires Lincoln Park to purchase the Company’s
shares under the Purchase Agreement over the term of the
agreement. In no event will shares be sold to Lincoln Park at a price
of less than $0.30. Under the Purchase Agreement, we may not sell to Lincoln
Park any shares of common stock in excess of 19.99% of our common stock
outstanding, unless and until such issuances are approved by our shareholders in
compliance with the NYSE Amex continued listing requirements to the extent that
such requirements apply to us, and in the event such approval is required under
the rules and regulations of the trading market where our securities are then
listed. Our ability to sell shares to Lincoln Park is also subject to our
obtaining all necessary consents, amendments or waivers as may be
required. The proceeds received by us under the Purchase Agreement
are expected to be used for debt service, working capital and general corporate
purposes.
As of
November 12, 2010, there were 42,382,311 shares of our common stock outstanding
(37,498,384 shares held by non-affiliates) excluding the shares offered to
Lincoln Park pursuant to this prospectus.
If all of
12,336,538 shares of our common stock offered hereby were issued and outstanding
as of the date hereof, (without taking into the account the 19.99% shareholder
approval limitation), this would represent approximately 23% of the
total common stock outstanding or 25% of the non-affiliate shares of common
stock outstanding as of the date hereof. We have agreed to register and this
prospectus covers (1) up to 12,000,000 shares of our common stock which we may
sell to Lincoln Park after the registration statement of which this prospectus
forms a part is declared effective and (2) 336,538 shares of our common stock
which we are obligated to issue to Lincoln Park in the future as a commitment
fee pro rata as we receive the $10 million. Under the Purchase
Agreement, we have the right but not the obligation to sell more than the
12,000,000 shares to Lincoln Park. As of the date hereof, we do not
currently have any plans or intent to issue to Lincoln Park any shares beyond
the 12,336,538 shares offered hereby. However, if we elect to issue
more than the 12,336,538 shares (which we have the right but not the obligation
to do), we must first register under the Securities Act, any additional shares
we may elect to sell to Lincoln Park before we can sell such additional shares,
which could cause substantial dilution to our stockholders.
4
RISK
FACTORS
An
investment in our securities involves a high degree of risk. Before you decide
to invest in our securities, you should consider carefully all of the
information in this prospectus, including the documents we incorporate by
reference into this prospectus, as well as the risks described
below. Any of these risks could have a material adverse effect on our
business, prospects, financial condition and results of operations. In any such
case, the trading price of our common stock could decline and you could lose all
or part of your investment. You should also refer to the other
information contained in this prospectus, or incorporated herein by reference,
including our financial statements and the notes to those statements, and the
information set forth under the caption “Forward Looking
Statements.” The risks described below and contained in our
other periodic reports are not the only ones that we face. Additional
risks not presently known to us or that we currently deem immaterial may also
adversely affect our business operations.
Risks
Relating to Our Business
There
is substantial doubt as to our ability to continue as a going
concern.
We have
suffered recurring losses from operations and have insufficient liquidity to
fund the ongoing operations which raise substantial doubt about our ability to
continue as a going concern. In addition, our financial statements have been
prepared on the assumption that we will continue as a going concern, which
contemplates the realization of assets and liquidation of liabilities in the
normal course of business. However, there is substantial doubt about our ability
to continue as a going concern. Accordingly, we will need to increase sales
volume and obtain additional capital to continue as a going concern and to fund
our operations, including to:
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·
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Continue
and increase investment in sales and marketing activities related to the
AutoloGel System
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·
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Pursue
a strategic partner for CT-112 (an anti-inflammatory
peptide);
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·
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Develop
additional new products and/or make improvements to existing
products;
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·
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Conduct
additional trial(s) or studies to support efforts to obtain Centers for
Medicare & Medicaid Services (“CMS”) reimbursement for our
products;
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·
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Pursue
existing and new claims covered by intellectual property we own or
contemplate;
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·
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Manage
and integrate successfully the recent acquisition of the Sorin
assets;
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·
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Service
the deferred payments on the same
acquisition;
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·
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Sustain
our corporate overhead requirements and hire and retain necessary
personnel; and
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|
·
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Pursue
other potential attractive
opportunities.
|
Until we
can generate a sufficient amount of product revenue to finance our cash
requirements, which we may not accomplish, we expect to finance future cash
needs primarily through offerings of our debt or equity securities, strategic
collaborations, or government grants.
We do not
know whether additional funding will be available on acceptable terms, or at
all. If we are not able to secure additional funding when needed, we may have to
delay, reduce the scope, or eliminate one or more of our programs, or
substantially curtail or close our operations altogether. In addition, we may
have to partner one or more of our technologies at an earlier stage of
development, which could lower the economic value of those programs to
us.
We
have limited sources of working capital as we are not permitted to raise debt
financing and as licensing agreements that provided most of our historical
revenues were not renewed.
Because
we were in bankruptcy in 2002 and due to the rights of some of our preferred
shareholders, we may not be able to obtain debt financing. Working capital
required to implement our business plan will most likely be provided by funds
obtained through offerings of our equity securities, and revenues generated by
us. No assurance can be given that we will have revenues sufficient to support
and sustain our operations or that we would be able to obtain equity financing
in the current economic environment.
5
To date,
the overwhelming majority of our revenues have been provided by our licensing
agreements. However, these agreements expired in November 2009. There is no
assurance that we will be able to replace permanently these revenues through
product sales, new licensing agreements or other sources. If we do not have
sufficient working capital and are unable to generate revenues or raise
additional funds, we may delay the completion of or significantly reduce the
scope of our current business plan; delay some of our development and clinical
or marketing testing, our plans to pursue Medicare and/or commercial insurance
reimbursement for our wound treatment technologies; or postpone the hiring of
new personnel; or, under certain dire financial circumstances, cease our
operations.
We
need substantial additional financing, which may be provided by amounts raised
under the Purchase Agreement.
We need
substantial additional capital to fund our operations. To date, we have relied
almost exclusively on financing transactions to fund our operations. Our
inability to obtain sufficient additional financing would have a material
adverse effect on our ability to implement our business plan and, as a result,
could require us to diminish or suspend activities. At September 30, 2010, we
had cash and cash equivalents of approximately $620 thousand, total current
assets of approximately $3.7 million and total current liabilities of
approximately $4.8 million. Under our current operating plan, and assuming we
are able to sell the maximum of $10 million from the Purchase Agreement, we
believe we can fund our operations through 2011. However, our
projections could be wrong. We could face unforeseen costs or our revenues could
fall short of our projections. In addition, there is no assurance that we will
be able to sell a sufficient number of shares under the Purchase Agreement to
raise the aforementioned financing. New sources of capital may not be
available to us when we need them or may be available only on terms we would not
find acceptable. Additional financing will likely cause dilution to our
stockholders and could involve the issuance of securities with rights senior to
the outstanding shares. There is no assurance that such financing will be
sufficient, that the financing will be available on terms acceptable to us and
at such times as required, or that we will be able to obtain the additional
financing required, if any, for the continued operation and growth of our
business. Any inability to raise necessary capital will have a material adverse
effect on our ability to implement our business strategy and will have a
material adverse effect on our revenues and net income.
We may
direct Lincoln Park to purchase up to $10 million of our shares of our common
stock under our Purchase Agreement over a 25 month period, generally in amounts
of up to 150,000 shares. However, Lincoln Park does not have the right nor the
obligation to purchase any shares of our common stock on any business day that
the price of our common stock is less than $.30 per share. We intend to register
12,000,000 shares for sale by Lincoln Park pursuant to this prospectus (not
including the commitment shares that are issuable to Lincoln
Park). In the event we elect to issue more than 12,336,538 shares
offered hereby, we will be required to file a new registration statement and
have it declared effective by the SEC. In addition, in the event that
we decide to issue more than 19.99% of our outstanding shares of
common stock as of the date of the Purchase Agreement, we would first be
required to seek shareholder approval in order to be in compliance with the NYSE
Amex rules, to the extent such rules apply to us at the time of such
issuance. The extent to which we rely on Lincoln Park as a source of
funding will depend on a number of factors including, the prevailing market
price of our common stock and the extent to which we are able to secure working
capital from other sources. Specifically, Lincoln Park does not have
the right nor the obligation to purchase any shares of our common stock on any
business days that the price of our common stock is less than $.30 per
share. If obtaining sufficient funding from Lincoln Park were to
prove unavailable or prohibitively dilutive, and if other sources of funding are
available to us, we may determine not to sell shares to Lincoln Park under the
Purchase Agreement.
There
is no assurance that we will successfully integrate the Angel and ActivAt
business, or that we will realize the anticipated synergies of the combined
businesses.
The Angel
and ActivAT business represent a significant increase in volume and revenue
compared to our existing product line of AutoloGel. There is no assurance that
we will successfully integrate any or all of the various aspects to the acquired
business, including but not limited to the sales, marketing, manufacturing,
distribution, regulatory, and other functions. Failure to smoothly and
successfully integrate the acquired business could lead to a reduction in
revenue for the Angel and ActivAT products compared to historical levels,
generate ill will among its customer base, and therefore have a material adverse
affect on us, our operations or the price of our common stock. Furthermore,
there is no assurance that we will realize synergies in the sales, marketing,
distribution, reimbursement, or other areas as we currently contemplate. In
addition, there is no assurance that we will realize any anticipated economies
of scale for the combined businesses.
6
Our
inability to make timely payments on the secured promissory note executed in the
Sorin acquisition may adversely affect our operations by permitting Sorin to
foreclose on the assets we acquired from Sorin.
We paid a
portion of consideration paid in connection with the Sorin acquisition by
executing a promissory note in the amount of $5 million with interest accruing
at 2.7% per annum, dated April 9, 2010. We are required to make periodic
installment payments on the note (the first installment of which was paid as
scheduled). The payments under the promissory note are secured by a first
priority security interest on the business assets acquired in the Sorin
acquisition. In the event we are unable to make such installment payments, we
may be held in default of the Sorin note, and Sorin may foreclose upon all the
assets that we acquired from Sorin in April 2010 and, therefore, our business
and operations may be adversely affected in the event we are unable to make
timely principal and interest payments or default on such promissory
note.
Our
Securities May Be Delisted for Non-Compliance with the NYSE Amex Continued
Listing Requirements
As a NYSE
Amex listed company, we are required to comply with the continued listing
criteria of the exchange. As previously disclosed, the Company was
notified by the NYSE Amex (the "Exchange") of its non-compliance with Sections
1003(a)(i), 1003(a)(ii) and 1003(a)(iii) of the Exchange Company Guide relating
to its shareholders' equity. On November 15, 2010, NYSE Amex LLC (the
"Exchange") notified us that the Exchange intended to strike the listing of our
securities from the Exchange pursuant to Section 1009(d) of the NYSE Amex LLC
Company Guide. The staff letter also informed the Company that it had
the right to appeal the delisting determination. The Company intends
to avail itself of the right to appeal the Staff Determination and seek an oral
hearing before a Listing Qualifications Panel of the Exchange (the "Panel"). The
time and place of such a hearing will be determined by the Panel. A request for
an oral hearing will stay the scheduled delisting of the Company's securities
pending the Panel's determination. There can be no assurance that the Panel will
grant the Company's request for continued listing. If the Panel does not grant
the relief sought by the Company, its securities will be delisted from the
Exchange in which event the Company would seek to cause them be quoted on the
OTC Bulletin Board ("OTC-BB"). Management anticipates that although quotation of
Company securities on the OTC-BB may result in a less liquid market for the
securities, public trading of Company securities would continue without
interruption by holders desiring to trade.
Adverse
conditions in the global economy and disruption of financial markets may
significantly restrict our ability to generate revenues or obtain debt or equity
financing.
The
global economy continues to experience volatility and uncertainty. Such
conditions could reduce demand for our products which would significantly
jeopardize our ability to achieve meaningful market penetration for AutoloGel
and continued sales of Angel and ActivAT products. These conditions could also
affect our potential strategic partners, which, in turn, could make it much more
difficult to execute a strategic collaboration, and therefore significantly
jeopardize our ability to fully develop CT-112. Global credit and capital
markets continue to be relatively challenging. We may be unable to obtain
capital through issuance of our equity securities, a significant source of
funding for us throughout our history. If we are unable to secure funding
through strategic collaborations, equity investments, or debt financing, we may
not be able to achieve profitability, which may result in a cessation of
operations.
Business
credit and liquidity have tightened in much of the world. Volatility and
disruption of financial markets could limit our customers’ ability to obtain
adequate financing or credit to purchase and pay for our products in a timely
manner, or to maintain operations, and result in a decrease in sales volume.
General concerns about the fundamental soundness of domestic and international
economies may also cause customers to reduce purchases. Changes in governmental
banking, monetary and fiscal policies to restore liquidity and increase credit
availability may not be effective. Economic conditions and market turbulence may
also impact our suppliers’ ability to supply sufficient quantities of product
components in a timely manner, which could impair our ability to fulfill sales
orders. It is difficult to determine the extent of the economic and financial
market problems and the many ways in which they may affect our suppliers,
customers, investors, and business in general. Continuation or further
deterioration of these financial and macroeconomic conditions could
significantly harm sales, profitability and results of
operations.
7
Economic
downturns or other adverse economic changes (local, regional, or national) can
also hurt our financial performance in the form of lower interest earned on
investments and/or could result in losses of portions of principal in our
investment portfolio. While our investment policy requires us to invest only in
short-term, low risk investments, there is no assurance that principal will not
be eroded as a significant portion of these investments is in excess of
federally mandated insurance.
We
have a history of losses and expect to incur losses for the foreseeable
future.
We have a
history of losses, are not currently profitable, and expect to incur substantial
losses and negative operating cash flows for the foreseeable future. We may
never generate sufficient revenues to achieve and maintain profitability. We
will continue to incur expenses at current levels as we seek to expand our
operations, pursue development of our technologies, work to increase our sales,
implement internal systems and infrastructure, and hire additional personnel.
These ongoing financial losses may adversely affect our stock
price.
We
have a short operating history and limited operating experience.
We must
be evaluated in light of the uncertainties and complexities affecting an early
stage biotechnology company. We have only recently implemented our
commercialization strategy. Thus, we have a very limited operating history.
Continued operating losses, together with the risks associated with our ability
to gain new customers for our product offerings, may have a material adverse
effect on our liquidity. We may also be forced to respond to unforeseen
difficulties, such as a decreased demand for our products, downward pricing
trends, and services, regulatory requirements and unanticipated market
pressures. Since emerging from bankruptcy and continuing through today, we are
developing a business model that includes protecting our patent position,
addressing our third-party reimbursement issues, developing and executing a
sales and marketing program, and developing other technologies covered by, or
derived from, our intellectual property. There can be no assurance that our
business model in its current form can accomplish our stated goals.
Our
intellectual property assets are critical to our success.
We regard
our patents, trademarks, trade secrets and other intellectual property assets as
critical to our success. We rely on a combination of patents, trademarks, and
trade secret and copyright laws, as well as confidentiality procedures,
contractual provisions, and other similar measures, to establish and protect our
intellectual property. We attempt to prevent disclosure of our trade secrets by
restricting access to sensitive information and requiring employees,
consultants, and other persons with access to our sensitive information to sign
confidentiality agreements. Despite these efforts, we may not be able to prevent
misappropriation of our technology or deter others from developing similar
technology in the future. Furthermore, policing the unauthorized use of our
intellectual property assets is difficult and expensive. Litigation has been
necessary in the past and may be necessary in the future in order to protect our
intellectual property assets. Litigation could result in substantial costs and
diversion of resources. We can provide no assurance that we will be successful
in any litigation matter relating to our intellectual property assets.
Continuing litigation or other challenges could result in one or more of our
patents being declared invalid. In such a case, any royalty revenues from the
affected patents would be adversely affected although we may still be able to
continue to develop and market our products. Furthermore, the unauthorized use
of our patented technology by otherwise potential customers in our target
markets may significantly undermine our ability to generate
sales.
8
Our
patent covering the specific gel formulation that is applied as part of the
AutoloGel™ System (the ‘‘Worden Patent’’) expires no earlier than February 2019.
Our U.S. Knighton Patent (which was the subject of license agreements between us
and Medtronic, Inc., DePuy Spine, Inc., Biomet Biologics, Inc., COBE
Cardiovascular, Inc., and Harvest Technologies Corporation, among others)
expired in November 2009. In 2009, the license agreements under the Knighton
Patent accounted for approximately 89% of our revenues. Although the recent
acquisition of the Sorin assets was intended to, among other things, replace the
foregoing revenue loss, we provide no assurance that we will be successful in
fully replacing and sustaining such revenue replacement of the royalty revenue.
Furthermore, we may be more vulnerable to competitive factors because third
parties will not then need a license from us to perform the methods claimed in
the Knighton Patent.
Our
products are subject to governmental regulation.
Our
success is also impacted by factors outside of our control. Our current
technology and products may be subject to extensive regulation by numerous
governmental authorities in the United States, both federal and state, and in
foreign countries by various regulatory agencies. Specifically, our devices and
bio-pharmaceutical products are subject to regulation by the FDA and state
regulatory agencies. The FDA regulates drugs, medical devices and biologics that
move in interstate commerce and requires that such products receive clearance or
pre-marketing approval based on evidence of safety and efficacy. The regulations
of government health ministries in foreign countries are analogous to those of
the FDA in both application and scope. In addition, any change in current
regulatory interpretations by, or positions of, state regulatory officials where
the AutoloGel System is used could materially and adversely affect our ability
to sell products in those states. The FDA will require us to obtain clearance or
approval of new devices when used for treating specific wounds or marketed with
specific wound healing claims, or for other products under
development.
Clinical
trials may fail to demonstrate the safety or efficacy of our product
candidates
Our
product candidates are subject to the risks of failure inherent in the
development of biotherapeutic products. The results of early-stage clinical
trials do not necessarily predict the results of later-stage clinical trials.
Product candidates in later-stage clinical trials may fail to demonstrate
desired safety and efficacy traits despite having successfully progressed
through initial clinical testing. Even if we believe the data collected from
clinical trials of its product candidates is promising, this data may not be
sufficient to support approval by the U.S. or foreign regulatory agencies.
Pre-clinical and clinical data can be interpreted in different ways.
Accordingly, the regulatory officials could reach different conclusions in
assessing such data, which could delay, limit or prevent regulatory approval. In
addition, the U.S. regulatory authorities or we may suspend or terminate
clinical trials at any time. Any failure or delay in completing clinical trials
for product candidates, or in receiving regulatory approval for the sale of any
product candidates, has the potential to materially harm our business, and may
prevent it from raising necessary, additional financing that may be needed in
the future.
We
believe that the AutoloGel System and all our products are legally marketed. The
FDA has cleared us to market the AutoloGel System, including the wound dressing
kit and centrifuge II, for use in exuding wounds such as leg ulcers, pressure
ulcers, and diabetic ulcers, and the management of mechanically and
surgically-debrided wounds. As we expand and offer additional products in the
United States and in foreign countries, clearance or approval from the FDA and
comparable foreign regulatory authorities prior to introduction of any such
products into the market may be required. We provide no assurance that we will
be able to obtain all necessary approvals from the FDA or comparable regulatory
authorities in foreign countries for these products. Failure to obtain the
required approvals would have a material adverse impact on our business and
financial condition. The Angel System received market clearance from the FDA in
August 2005.
Compliance
with FDA and other governmental requirements imposes significant costs and
expenses. Further, our failure to comply with these requirements could result in
sanctions, limitations on promotional or other business activities, or other
adverse effects on our business. Further, recent efforts to control healthcare
costs could negatively affect demand for our products and
services.
9
A
disruption in healthcare provider networks could have an adverse effect on our
operations and profitability.
Our
operations and future profitability are dependent, in large part, upon the
ability to contract with healthcare providers on favorable terms. In any
particular service area, healthcare providers could refuse to contract with
Cytomedix or take other actions that could result in higher healthcare costs, or
create difficulties in meeting our regulatory requirements. In some service
areas, certain healthcare providers may have a significant market presence. If
healthcare providers refuse to contract with us, use their market position to
negotiate unfavorable contracts or place us at a competitive disadvantage, our
ability to market services or to be profitable in those service areas could be
adversely affected. Provider networks could also be disrupted by the financial
insolvency of a large healthcare provider group. Any disruption in provider
networks could adversely impact our ability to generate revenues or
profits.
Our
sales and marketing strategy for AutoloGel system may not succeed.
In
January 2009, we implemented a revised sales and marketing strategy that focuses
on intensive clinician to clinician interaction with both prospective and
existing customers, and the scientific explanation of AutoloGel’s mechanism of
action. There is no assurance that this approach will result in significant,
sustainable growth in sales revenue, or that we, as currently capitalized, will
have sufficient resources to provide the level of clinical support for this
initiative to be successful.
CMS’s
non-coverage of AutoloGel could greatly restrict our sales.
The
AutoloGel System is marketed to healthcare providers. Some of these providers,
in turn, seek reimbursement from third-party payers such as Medicare, Medicaid,
and other private insurers. Many foreign countries also have comprehensive
government managed healthcare programs that provide reimbursement for healthcare
products. Under such healthcare systems, reimbursement is often a determining
factor in predicting a product’s success, with some physicians and patients
strongly favoring only those products for which they will be reimbursed. With
CMS’s national non-coverage determination, the market for the AutoloGel System
is restricted and it may be difficult, if not impossible, to sell AutoloGel in
most care settings. This currently hinders our ability to grow its revenues and
could reduce the likelihood that it will ever achieve sustainable profitability.
We provide no assurance that our efforts to obtain CMS coverage will be
successful.
Our
intention to develop a plan to secure Medicare reimbursement without conducting
a new randomized controlled trial may not be successful.
In March
2008, CMS reaffirmed its 2003 non-coverage determination for autologous platelet
rich plasma, which would include AutoloGel. Following CMS’s decision, we met
with CMS, in April 2008, to discuss the optimal path for securing future
coverage for AutoloGel and in concert with consultants and advisors, have
developed a multi-pronged strategy to obtain Medicare reimbursement for
AutoloGel. We provide no assurance that we will ultimately be successful with
this strategy and that CMS will decide that the evidence is sufficient to
reverse all or a portion of its existing non-coverage determination. If we later
determine that a new randomized, controlled trial is necessary, it could cost
several millions of dollars and take multiple years to complete. We would almost
certainly need to obtain additional, outside financing to fund such a
trial.
We
may be unable to attract a strategic partner for the further development of
CT-112.
Due to
our limited resources, we have determined that the best vehicle to move the
development of CT-112 forward is through a strategic partnership, outlicensing,
or other similar arrangement. While we are engaged in ongoing discussions with
potential partners or licensees, there is no assurance that we will be able to
come to any such agreement. Furthermore, even if such a strategic relationship
regarding CT-112 is reached, there is no assurance that development milestones,
clinical data, or other such benchmarks will be achieved. Therefore, CT-112 may
never proceed toward commercialization or drive cash infusions for us, and we
may ultimately not be able to monetize the patents, existing clinical data, and
other intellectual property related to CT-112.
10
The
success of our products is dependent on acceptance by the medical
community.
The
commercial success of our products and processes will depend upon the medical
community and patients accepting the therapies as safe and effective. If the
medical community and patients do not ultimately accept the therapies as safe
and effective, our ability to sell the products will be materially and adversely
affected. While acceptance by the medical community may be fostered by broad
evaluation via peer-reviewed literature, we may not have the resources to
facilitate sufficient publication.
We
may be unable to attract and retain key personnel.
Our
future success depends on the ability to attract, retain and motivate highly
skilled management, including sales representatives. We have retained a team of
highly qualified officers and consultants, but cannot provide assurance that we
will be able to successfully retain all of them, or be successful in recruiting
additional personnel as needed. Our inability to do so will materially and
adversely affect the business prospects, operating results and financial
condition. Our ability to maintain and provide additional services to our
customers depends upon our ability to hire and retain business development and
scientific and technical personnel with the skills necessary to keep pace with
continuing changes in regenerative biological therapy technologies. Competition
for such personnel is intense; we compete with pharmaceutical, biotechnology and
healthcare companies. Our inability to hire additional qualified personnel may
lead to higher recruiting, relocation and compensation costs for such personnel.
These increased costs may reduce our profit margins or make hiring new personnel
impractical.
Legislative
and administrative action may have an adverse effect on our
company.
Political,
economic and regulatory influences may subject the health care industry in the
United States to fundamental change. We cannot predict what other legislation
relating to our business or to the health care industry may be enacted,
including legislation relating to third-party reimbursement, or what effect such
legislation may have on our business, prospects, operating results and financial
condition. We expect federal and state legislators to continue to review and
assess alternative health care delivery and payment systems and possibly adopt
legislation affecting fundamental changes in the health care delivery system.
Such laws may contain provisions that may change the operating environment for
hospitals and managed care organizations. Health care industry participants may
react to such legislation by curtailing or deferring expenditures and
initiatives, including those relating to our products. Future legislation could
result in modifications to the existing public and private health care insurance
systems that would have a material adverse effect on the reimbursement policies
discussed above. With growing pressures on government budgets due to the current
economic downturn, government efforts to contain or reduce health care spending
are likely to gain increasing emphasis. Several members of the current
presidential administration and Congress are espousing support for
cost-containment measures that could have significant implications for
healthcare therapies, including our current and future products. If enacted and
implemented, such measures could result in decreased revenue from our products
and decrease potential returns from our research and development initiatives.
Furthermore, there is no assurance that we will be able to successfully
neutralize any lobbying efforts against our efforts to secure Medicare coverage
or other initiatives we may have with governmental agencies.
We
could be affected by malpractice claims.
Providing
medical care entails an inherent risk of professional malpractice and other
claims. We do not control or direct the practice of medicine by physicians or
health care providers who use the products and do not assume responsibility for
compliance with regulatory and other requirements directly applicable to
physicians. There is no assurance that claims, suits or complaints relating to
the use of our products and treatment administered by physicians will not be
asserted against us in the future. The production, marketing and sale, and use
of our products entails risks that product liability claims will be asserted
against us. These risks cannot be eliminated, and we could be held liable for
any damages that result from adverse reactions or infectious disease
transmission. Such liability could materially and adversely affect our business,
prospects, operating results and financial condition. We currently maintain
professional and product liability insurance coverage, but cannot give assurance
that the coverage limits of this insurance would be adequate to protect against
all potential claims. We cannot assure that we will be able to obtain or
maintain professional and product liability insurance in the future on
acceptable terms or with adequate coverage against potential
liabilities.
11
Our
products have existing competition in the marketplace, and many of our
competitors have significantly greater financial and marketing resources than
us.
In the
market for biotechnology products, we face competition from pharmaceutical
companies, biopharmaceutical companies, medical device companies, and other
competitors. Other companies have developed or are developing products that may
be in direct competition with our current product line. Biotechnology
development projects are characterized by intense competition. Thus, we cannot
assure any investor that we will be the first to the market with any newly
developed products or that we will successfully be able to market these
products. If we are not able to participate and compete in the regenerative
biological therapy market, our financial condition will be materially and
adversely affected. We cannot assure that we will be able to compete effectively
against such companies in the future. Many of these companies have substantially
greater capital resources, larger marketing staffs and more experience in
commercializing products. Recently developed technologies, or technologies that
may be developed in the future, may be the basis for developments that will
compete with our products.
Risks
Relating to Our Common Stock
The
sale of our common stock to Lincoln Park may cause substantial dilution to our
existing stockholders and the sale of the shares of common stock acquired by
Lincoln Park could cause the price of our common stock to decline.
This
offering relates to up to $10 million of our common stock that we may sell to
Lincoln Park. The shares offered to Lincoln Park may be sold over a
25-month period. The number of shares ultimately offered for sale by Lincoln
Park is dependent upon the number of shares we elect to sell to Lincoln Park
under the Purchase Agreement, subject in certain cases to shareholder approval
requirements in compliance with the NYSE Amex requirements. Depending upon
market liquidity at the time, sales of shares of our common stock by Lincoln
Park may cause the trading price of our common stock to decline. After it has
acquired shares under the Purchase Agreement, Lincoln Park may sell all, some or
none of those shares. Sales to Lincoln Park by us pursuant to the Purchase
Agreement may result in substantial dilution to the interests of other holders
of our common stock. The sale of a substantial number of shares of our common
stock by Lincoln Park, or anticipation of such sales, could make it more
difficult for us to sell equity or equity-related securities in the future at a
time and at a price that we might otherwise wish to effect sales. However, we
have the right to control the timing and amount of any sales of our shares to
Lincoln Park and the Purchase Agreement may be terminated by us at any time at
our discretion without any cost to us.
Volatility
of our stock price could adversely affect current and future
stockholders.
The
market price of our common stock has been volatile, and fluctuates widely in
price in response to various factors which are beyond our control. The price of
our common stock is not necessarily indicative of our operating performance or
long-term business prospects. In addition, the securities markets have from time
to time experienced significant price and volume fluctuations that are unrelated
to the operating performance of particular companies. These market fluctuations
may also materially and adversely affect the market price of our common stock.
Factors such as the following could cause the market price of our common stock
to fluctuate substantially include, among others:
|
·
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our
ability or inability to execute our business
plan;
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·
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the
dilutive effect or perceived dilutive effect of additional equity
financings;
|
|
·
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investor
perception of our company and of the
industry;
|
|
·
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the
success of competitive products or
technologies;
|
|
·
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regulatory
developments in the United States or
overseas;
|
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·
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developments
or disputes concerning patents or other proprietary
rights;
|
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·
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the
recruitment or departure of key personnel;
or
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·
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general
economic, political and market
conditions.
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12
The
stock market in general has recently experienced extreme price and volume
fluctuations. Continued market fluctuations could result in extreme volatility
in the price of our common stock, which could cause a decline in the value of
our common stock. Price volatility could be worse if the trading volume of our
common stock is low.
We
may likely issue additional equity or debt securities which may materially and
adversely affect the price of our common stock.
Sales of
substantial amounts of shares of our common stock in the public market, or the
perception that those sales may occur, could cause the market price of our
common stock to decline. We have used, and will likely continue to use, our
common stock or securities convertible into or exchangeable for common stock to
fund working capital needs or to acquire technology, product rights or
businesses, or for other purposes. If additional equity securities are issued,
particularly during times when our common stock is trading at relatively low
price levels, the price of our common stock may be materially and adversely
affected.
There
is a limited public trading market for our common stock.
The
average daily trading volume in our common stock is relatively low. As long as
this condition continues, it could be difficult to sell a significant number of
shares of common stock at any particular time at the market prices prevailing
immediately before such shares are offered. Shareholders may be required to hold
shares of our common stock for an indefinite period of time. In addition, sales
of substantial amounts of common stock could lower the prevailing market price
of our common stock. This would limit or perhaps prevent our ability to raise
capital through the sale of securities. Additionally, we have significant
numbers of outstanding warrants and options that, if exercised and sold, could
put additional downward pressure on the common stock price. In addition, in
recent years, and especially in recent months, the stock market in general, and
the market for life sciences companies in particular, have experienced
significant price and volume fluctuations. This volatility has affected the
market prices of securities issued by many companies, often for reasons
unrelated to their operating performance, and it may adversely affect the price
of our common stock. These broad market fluctuations may reduce the demand for
our stock and therefore adversely affect the price of our securities, regardless
of operating performance.
We
are subject to anti-takeover provisions and laws.
Provisions
in our restated certificate of incorporation and restated bylaws and applicable
provisions of the Delaware General Corporation Law may make it more difficult
for a third party to acquire control of us without the approval of our Board of
Directors. These provisions may make it more difficult or expensive for a third
party to acquire a majority of our outstanding voting common stock or delay,
prevent or deter a merger, acquisition, tender offer or proxy contest, which may
negatively affect our common stock price.
Our
management will have broad discretion as to the use of the proceeds from the
Purchase Agreement, and we may not use the proceeds effectively.
We have
not designated the amount of net proceeds from the Purchase Agreement to be used
for any particular purpose. Accordingly, our management will have broad
discretion as to the application of the net proceeds from the Purchase
Agreement. Our shareholders may not agree with the manner in which our
management chooses to allocate and spend the net proceeds. Moreover, our
management may use the net proceeds for corporate purposes that may not increase
our profitability or market value.
You
will experience immediate dilution in the book value per share of the common
stock you purchase.
Because
the price per share of our common stock being offered is substantially higher
than the book value per share of our common stock, you will suffer substantial
dilution in the net tangible book value of the common stock you purchase in this
offering. Based on the assumed minimum allowed offering price of $0.30 per
share, if you purchase shares of common stock in this offering, you will suffer
dilution of $0.18 per share in the net tangible book value of the common stock.
See the section entitled “Dilution” below for a more detailed discussion of the
dilution you will incur if you purchase common stock in this
offering.
13
Our
publicly filed reports are subject to review by the SEC, and any significant
changes or amendments required as a result of any such review may result in
material liability to us and may have a material adverse impact on the trading
price of our common stock.
The
reports of publicly traded companies are subject to review by the SEC from time
to time for the purpose of assisting companies in complying with applicable
disclosure requirements, and the SEC is required to undertake a comprehensive
review of a company’s reports at least once every three years under the
Sarbanes-Oxley Act of 2002. SEC reviews may be initiated at any time. We could
be required to modify, amend or reformulate information contained in prior
filings as a result of an SEC review. Any modification, amendment or
reformulation of information contained in such reports could be significant and
result in material liability to us and have a material adverse impact on the
trading price of our common stock.
14
FORWARD-LOOKING
STATEMENTS
Some of
the statements made in this prospectus, including the documents incorporated by
reference into this prospectus, discuss future events and developments,
including our future business strategy and our ability to generate revenue,
income and cash flow. In some cases, you can identify forward-looking statements
by words or phrases such as “may,” “should,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “predicts,” “potential,” “continue,” “our future
success depends,” “seek to continue,” or the negative of these words or phrases,
or comparable words or phrases. These statements are only predictions that are
based, in part, on assumptions involving judgments about future economic,
competitive and market conditions and future business decisions, all of which
are difficult or impossible to predict accurately and many of which are beyond
our control. Actual events or results may differ materially. In evaluating these
statements, you should specifically consider various facts, including the risks
outlined in the “Risk Factors” section. Although we believe that the
expectations reflected in the forward-looking statements are reasonable, we
cannot guarantee future results, levels of activity, performance or
achievements. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date on which they are
made. We do not undertake to update any of the forward-looking statements after
the date of this prospectus to conform these statements to actual
results.
You
should read this prospectus and the documents that we reference in this
prospectus and have filed as exhibits to the registration statement, of which
this prospectus is a part, that we have filed with the SEC, completely and with
the understanding that our actual future results, levels of activity,
performance and achievements may be different from what we expect and that these
differences may be material. We qualify all of our forward-looking statements by
these cautionary statements. The forward-looking statements contained in this
prospectus are excluded from the safe harbor protection provided by the Private
Securities Litigation Reform Act of 1995 and Section 27A of the Securities
Act.
15
USE
OF PROCEEDS
This
prospectus relates to shares of our common stock that may be offered and sold
from time to time by the Selling Stockholder. We will receive no
proceeds from the sale of shares of common stock in this offering that are made
by the Selling Stockholder. However, we may receive proceeds of up to
$10,000,000 under the Purchase Agreement, subject to the terms and restrictions
of such agreement. The proceeds received by us under the Purchase
Agreement are expected to be used for debt service, working capital and general
corporate purposes.
16
MARKET
PRICE OF OUR COMMON STOCK
AND
RELATED STOCKHOLDER MATTERS
Market
Information
Since
June 2005, the Company’s common stock has been listed on the NYSE Amex (formerly
the American Stock Exchange); its current trading symbol is “GTF.BC”. Set forth
below are the high and low sales prices for the common stock for each quarter in
the two most recent fiscal years and the period ended September 30, 2010 as
reported by NYSE Amex. Such quotation reflects inter-dealer prices, without
retail markup, markdown, or commission, and may not represent actual
transactions.
Quarter
Ended
|
High
|
Low
|
||||||
September
30, 2010
|
$ | 0.75 | $ | 0.48 | ||||
June
30, 2010
|
$ | 1.75 | $ | 0.41 | ||||
March
31, 2010
|
$ | 0.68 | $ | 0.39 | ||||
December
31, 2009
|
$ | 0.66 | $ | 0.36 | ||||
September
30, 2009
|
$ | 0.81 | $ | 0.35 | ||||
June
30, 2009
|
$ | 1.05 | $ | 0.28 | ||||
March
31, 2009
|
$ | 0.60 | $ | 0.18 | ||||
December
31, 2008
|
$ | 0.84 | $ | 0.15 | ||||
September
30, 2008
|
$ | 0.90 | $ | 0.45 | ||||
June
30, 2008
|
$ | 1.09 | $ | 0.60 | ||||
March
31, 2008
|
$ | 2.04 | $ | 0.58 |
As of
November 12, 2010, there were approximately 42,382,311 shares of our common
stock outstanding, held by approximately 610 shareholders of
record.
On
November 12, 2010, the last sale price of our common stock as reported on the
NYSE Amex was $0.51 per share.
Dividends
Holders
of common stock are entitled to receive dividends as may from time to time be
declared by the board of directors at their sole discretion. We did not pay
dividends to holders of our common stock during 2004 through 2009. We do not
anticipate paying cash dividends on our common stock in 2010 or in the
foreseeable future, but instead will retain any earnings to fund our growth. In
fact, we are prohibited from declaring dividends on our common stock as long as
any dividends on shares of Series A, Series B or Series D convertible preferred
are unpaid and outstanding. Once there are no dividends unpaid and outstanding
on any shares of Series A, Series B or Series D convertible preferred, any
decision to pay cash dividends will depend on our ability to generate earnings,
our need for capital, our overall financial condition, and other factors our
Board deems relevant.
17
DILUTION
If
you invest in our common stock, your interest in the common stock contained
therein will be diluted to the extent of the difference between the public
offering price per share of our common stock and the net tangible book value per
share of our common stock after this offering. Our net tangible book value on
September 30, 2010 was approximately ($2,648,173), or approximately ($0.07) per
share of common stock. Net tangible book value per share is determined by
dividing our net tangible book value, which consists of tangible assets less
total liabilities, by the number of shares of common stock outstanding on that
date. Dilution in net tangible book value per share represents the difference
between the amount per share paid by purchasers of common stock in this offering
(assuming a purchase price of $0.30 per share) and the net tangible book value
per share of common stock immediately after the completion of this offering.
Without taking into account any other changes in our net tangible book value
after September 30, 2010, other than the issuance of 3,727,677 issued in
connection with a registered direct offering on October 7, 2010 that generated
net proceeds of approximately $1.3 million, and our assumed receipt of the $3.6
million in estimated proceeds from the sale of 12,000,000 shares of common stock
issuable under the Purchase Agreement and registered in this offering (assuming
a purchase price of $0.30 per share, which is the minimum purchase price at
which shares can be sold under the Purchase Agreement, and assuming all such
sales were made as of September 30, 2010), our pro forma net tangible book value
as of September 30, 2010, would have been approximately $2.25 million, or $0.04
per share. This would represent an immediate increase in the net tangible book
value of $0.07 per share to existing stockholders attributable to this offering.
The following table illustrates this per share dilution:
Public
offering price per unit (assumed minimum allowed price):
|
$ | 0.30 | ||
Net
tangible book value per share as of September 30, 2010 (as adjusted for
October 7, 2010 offering):
|
$ | ( 0.03 | ) | |
Increase
in net tangible book value per share attributable to this
offering:
|
$ | 0.07 | ||
Pro
forma net tangible book value per share as of September 30, 2010 after
giving effect to this offering:
|
$ | 0.04 | ||
Dilution
per share to new investors in this offering:
|
$ | 0.26 |
To the
extent that we do not sell the $3.6 million available amount under the Purchase
Agreement, or to the extent that some or all sales are made at prices in excess
of the minimum purchase price, then the dilution reflected in the table above
would differ. The above table is based on 37,722,928 shares of our common stock
outstanding as of September 30, 2010, adjusted for the issuance of 3,727,677
issued in connection with a registered direct offering on October 7, 2010 for
net proceeds of approximately $1.3 million, and the assumed sale of $3.6 million
in shares in this offering at the assumed minimum purchase price described
above.
18
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Set forth
below is information regarding the beneficial ownership of our common stock, as
of November 12, 2010, by:
|
·
|
each
person known to us that beneficially owns more than 5% of our outstanding
shares of common stock;
|
|
·
|
each
of our directors;
|
|
·
|
each
of our named executive officers;
and
|
|
·
|
all
of our current directors and executive officers as a
group.
|
We
believe that, except as otherwise noted below, each named beneficial owner has
sole voting and investment power with respect to the shares listed. Unless
otherwise indicated herein, beneficial ownership is determined in accordance
with the rules of the Securities and Exchange Commission, and includes voting or
investment power with respect to shares beneficially owned. Shares of common
stock underlying options or warrants currently exercisable or exercisable on or
within 60 days of the date of this proxy statement are deemed outstanding for
computing the percentage ownership of the person holding the options or
warrants, but are not deemed outstanding for computing the percentage ownership
of any other person.
Name of Beneficial Owner
|
Amount and Nature of
Beneficial Ownership(1)
|
Percent of Class(1)
|
||||||
James
S. Benson
|
270,000 | (2) | * | |||||
David
E. Jorden
|
5,417,226 | (3) | 12.6 | % | ||||
Stephen
N. Keith
|
80,000 | (4) | * | |||||
Andrew
S. Maslan
|
413,802 | (5) | * | |||||
Mark
T. McLoughlin
|
290,001 | (6) | * | |||||
Craig
B. Mendelsohn
|
35,000 | (7) | * | |||||
Martin
P. Rosendale
|
911,420 | (8) | 2.1 | % | ||||
Patrick
Vanek
|
0 | (9) | * | |||||
C.
Eric Winzer
|
80,000 | (10) | * | |||||
John
Paul DeJoria
|
4,506,762 | (11) | 9.9 | % | ||||
Charles
E. Sheedy
|
4,442,345 | (12) | 9.9 | % | ||||
Directors
and executive officers as a group (including Benson, Jorden, Keith,
Maslan, McLoughlin, Mendelsohn, Rosendale, Vanek and
Winzer)
|
7,497,449 | 16.7 | % |
*Less
than 1%.
19
(1) For
purposes of determining the amount of securities beneficially owned, share
amounts include all common stock owned outright plus all shares of common stock
issuable upon conversion of convertible preferred stock, or the exercise of
options or warrants currently exercisable, or exercisable within 60 days of
November 12, 2010. The Percent of Class is based on the number of shares of the
Company’s common stock outstanding as of November 12, 2010. Shares of common
stock issuable upon conversion of convertible preferred stock, or the exercise
of options or warrants currently exercisable, or exercisable within 60 days of
November 12, 2010 are deemed outstanding for the purpose of computing the
percentage ownership of the person holding such options or warrants, but are not
deemed outstanding for computing the percentage ownership of any other owners.
The address of all persons named in this table is: c/o Cytomedix, Inc., 209
Perry Parkway, Suite 7, Gaithersburg, MD 20877.
(2) Consists
of 270,000 shares Mr. Benson may acquire upon the exercise of stock
options.
(3) Includes
4,742,500 shares of common stock, 143,369 shares of common stock issuable upon
conversion of the Series D Convertible Preferred Stock and 531,357 shares of
common stock issuable upon exercise of warrants and stock options held by Mr.
Jorden.
(4) Consists
of 80,000 shares Dr. Keith may acquire upon the exercise of stock
options.
(5) Includes
57,520 shares of common stock, 17,921 shares of common stock issuable upon
conversion of the Series D Convertible Preferred Stock and 338,361 shares of
common stock issuable upon exercise of warrants and stock options held by Mr.
Maslan.
(6) Includes
13,334 shares of common stock and 276,667 shares Mr. McLoughlin may acquire upon
the exercise of warrants and stock options.
(7) Consists
of 35,000 shares Mr. Mendelsohn may acquire upon the exercise of stock
options.
(8) Includes
70,573 shares of common stock, 35,842 shares of common stock issuable upon
conversion of the Series D Convertible Preferred Stock and 805,005 shares of
common stock issuable upon exercise of warrants and stock options held by Mr.
Rosendale.
(9) Mr.
Vanek, an officer of the Company, does not currently own any shares or hold any
options that are exercisable within 60 days of the date that this table was
prepared.
(10) Consists
of 80,000 shares Mr. Winzer may acquire upon the exercise of stock
options.
(11) Mr.
DeJoria’s beneficial ownership of the Company’s securities includes 1,801,661
shares of common stock, 1,170,000 shares of common stock issuable upon
conversion of the Series D Convertible Preferred Stock and 1,535,101 shares of
common stock issuable upon exercise of warrants held by held by Mr. DeJoria. The
terms of the Series D Convertible Preferred Stock provide that the holder is
limited in the number of shares it may convert into such that it will not own in
excess of 9.99% of the then outstanding shares of common stock. Absent such
restriction on his beneficial ownership, Mr. DeJoria would currently be deemed a
beneficial owner of an aggregate of 5,613,629 shares of common stock or 12.2% of
the Company’s securities.
(12) Mr.
Sheedy’s beneficial ownership of the Company’s securities includes 2,390,122
shares of common stock, 390,000 shares of common stock issuable upon conversion
of the Series D Convertible Preferred Stock and 1,662,223shares of common stock
issuable upon exercise of warrants held by Mr. Sheedy. The terms of the Series D
Convertible Preferred Stock provide that the holder is limited in the number of
shares it may convert into such that it will not own in excess of 9.99% of the
then outstanding shares of common stock. Absent such restriction on his
beneficial ownership, Mr. Sheedy would be deemed a beneficial owner of an
aggregate of 6,329,212 shares of common stock or 13.7% of the Company’s
securities.
20
SELLING
SECURITY HOLDER
The
following table presents information regarding the Selling Stockholder. Neither
the Selling Stockholder nor any of its affiliates has held a position or office,
or had any other material relationship, with us.
Selling Stockholder
|
Shares Beneficially
Owned Before
Offering
|
Percentage of
Outstanding Shares
Beneficially Owned
Before Offering
|
Shares to be Sold in
the Offering
Assuming The
Company Issues
The Maximum
Number of Shares
Under the Purchase
Agreement
|
Percentage of
Outstanding
Shares
Beneficially
Owned After
Offering
|
||||||||||||
Lincoln Park Capital Fund, LLC (1)
|
1,000,000 | (2) | 2.4 | % (2) | 12,336,538 | 1.8 | % |
(1) Joshua
Scheinfeld and Jonathan Cope, the principals of Lincoln Park, are deemed to be
beneficial owners of all of the shares of common stock owned by Lincoln Park.
Messrs. Scheinfeld and Cope have shared voting and disposition power over the
shares being offered under this prospectus.
(2) 1,000,000
shares of our common stock are already owned by Lincoln Park, which shares
include (i) 305,944 shares of the Company’s restricted common stock, and (ii)
694,056 shares acquired by Lincoln Park in connection with the October 2010
registered direct offering of the Company’s securities. We may at our discretion
elect to issue to Lincoln Park up to an additional 12,336,538 shares of our
common stock under the Purchase Agreement, subject to the terms and provisions
of such agreement, but Lincoln Park does not beneficially own any such shares
that may be issued by us at our sole discretion and such shares are not included
in determining the percentage of shares beneficially owned before the
offering.
Other
Information With Respect to Lincoln Capital
Lincoln
Park is not a licensed broker-dealer or an affiliate of a licensed
broker-dealer.
21
PLAN
OF DISTRIBUTION
The
common stock offered by this prospectus is being offered by the Selling
Stockholder. The common stock may be sold or distributed from time to time by
the Selling Stockholder directly to one or more purchasers or through brokers,
dealers, or underwriters who may act solely as agents at market prices
prevailing at the time of sale, at prices related to the prevailing market
prices, at negotiated prices, or at fixed prices, which may be changed. The sale
of the common stock offered by this prospectus may be affected in one or more of
the following methods:
|
·
|
ordinary
brokers’ transactions;
|
|
·
|
transactions
involving cross or block trades;
|
|
·
|
through
brokers, dealers, or underwriters who may act solely as
agents
|
|
·
|
“at
the market” into an existing market for the common
stock;
|
|
·
|
in
other ways not involving market makers or established business markets,
including direct sales to purchasers or sales effected through
agents;
|
|
·
|
in
privately negotiated transactions;
or
|
|
·
|
any
combination of the foregoing.
|
In
order to comply with the securities laws of certain states, if applicable, the
shares may be sold only through registered or licensed brokers or dealers. In
addition, in certain states, the shares may not be sold unless they have been
registered or qualified for sale in the state or an exemption from the
registration or qualification requirement is available and complied
with.
Brokers,
dealers, underwriters or agents participating in the distribution of the shares
as agents may receive compensation in the form of commissions, discounts, or
concessions from the Selling Stockholder and/or purchasers of the common stock
for whom the broker-dealers may act as agent. The compensation paid to a
particular broker-dealer may be less than or in excess of customary
commissions.
Lincoln
Park is an “underwriter” within the meaning of the Securities Act.
Neither
we nor Lincoln Park can presently estimate the amount of compensation that any
agent will receive. We know of no existing arrangements between Lincoln Park or
any other stockholder, broker, dealer, underwriter or agent relating to the sale
or distribution of the shares offered by this prospectus. At the time a
particular offer of shares is made, a prospectus supplement, if required, will
be distributed that will set forth the names of any agents, underwriters or
dealers and any compensation from the Selling Stockholder, and any other
required information.
We will
pay the expenses incident to the registration, offering and sale of the shares
to the public other than commissions or discounts of underwriters,
broker-dealers or agents. We have also agreed to indemnify Lincoln Park and
related persons against specified liabilities, including liabilities under the
Securities Act.
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to our directors, officers and controlling persons, we have been
advised that in the opinion of the SEC this indemnification is against public
policy as expressed in the Securities Act and is therefore,
unenforceable.
Lincoln
Park and its affiliates have agreed not to engage in any direct or indirect
short selling or hedging of our common stock during the term of the Purchase
Agreement.
We have
advised Lincoln Park that while it is engaged in a distribution of the shares
included in this prospectus it is required to comply with Regulation M
promulgated under the Exchange Act. With certain exceptions, Regulation M
precludes the Selling Stockholder, any affiliated purchasers, and any
broker-dealer or other person who participates in the distribution from bidding
for or purchasing, or attempting to induce any person to bid for or purchase any
security which is the subject of the distribution until the entire distribution
is complete. Regulation M also prohibits any bids or purchases made in order to
stabilize the price of a security in connection with the distribution of that
security. All of the foregoing may affect the marketability of the shares
offered by this prospectus.
This
offering will terminate on the date that all shares offered by this prospectus
have been sold by Lincoln Park or may be resold by Lincoln Park without
restriction under Rule 144(b)(1)(i) under the Securities Act.
22
DESCRIPTION
OF SECURITIES
All of
our common stock is of the same class, and each share has the same rights and
preferences. Holders of our common stock are entitled to one vote per share on
each matter submitted to a vote of the shareholders.
In the
event of liquidation, holders of common stock are entitled to share ratably in
the distribution of assets remaining after payment of liabilities, upon giving a
liquidation preference of $1.00 per share for each share of outstanding Series A
convertible preferred stock and Series B convertible preferred stock, and a
liquidation preference amount of $10,000 per share for each share of outstanding
Series D convertible preferred stock. The common stock is subordinate to the
Series A convertible preferred, Series B convertible preferred, and Series D
convertible preferred, and to all other classes and series of equity securities
which by their terms rank senior to the common stock, in the event of a
liquidation, dissolution, or winding up or with regard to any other rights,
privileges or preferences.
Holders
of common stock do not have any cumulative voting rights, preemptive rights,
conversion rights, redemption rights or sinking fund rights.
Holders
of common stock are entitled to receive dividends as may from time to time be
declared by the board of directors at their sole discretion. We did not pay
dividends to holders of our common stock during 2004 through 2009. We do not
anticipate paying cash dividends on our common stock in 2010 or in the
foreseeable future, but instead will retain any earnings to fund our growth. In
fact, we are prohibited from declaring dividends on our common stock as long as
any dividends on shares of Series A, Series B or Series D convertible preferred
are unpaid and outstanding. Once there are no dividends unpaid and outstanding
on any shares of Series A, Series B or Series D convertible preferred, any
decision to pay cash dividends will depend on our ability to generate earnings,
our need for capital, our overall financial condition, and other factors our
Board deems relevant.
Provisions
of Delaware law and our Certificate of Incorporation, as amended, and Bylaws
could make the acquisition of our company through a tender offer, a proxy
contest or other means more difficult and could make the removal of incumbent
officers and directors more difficult. We expect these provisions to discourage
coercive takeover practices and inadequate takeover bids and to encourage
persons seeking to acquire control of our company to first negotiate with our
Board. We believe that the benefits provided by our ability to negotiate with
the proponent of an unfriendly or unsolicited proposal outweigh the
disadvantages of discouraging these proposals. We believe the negotiation of an
unfriendly or unsolicited proposal could result in an improvement of its
terms.
We are
subject to the provisions of Section 203 of the Delaware Law. Subject to a
number of exceptions, Section 203 prohibits a publicly-held Delaware corporation
from engaging in a "business combination" with an "interested stockholder" for a
period of three years after the date of the transaction in which the person
became an interested stockholder, unless the business combination or the
transaction in which the person became an interested stockholder is approved in
a prescribed manner. A "business combination" includes a merger, asset sale,
stock sale, or other transaction resulting in financial benefit to the
stockholder. An "interested stockholder" is a person who, together with
affiliates and associates, owns, or within three years prior, did own, 15% or
more of the corporation's outstanding voting stock. This provision may have the
effect of delaying, deterring, or preventing a change of control without further
action by the shareholders.
Our
transfer agent for our Common Stock is StockTrans, located at 44 West Lancaster
Ave., Ardmore, Pennsylvania 19003. All inquiries may be made at 1-800-733-1121.
The transfer agent’s internet website address is www.stocktrans.com.
Our
common stock is listed on the NYSE Amex LLC under the symbol
“GTF.BC”
23
THE
TRANSACTION
THE
LINCOLN TRANSACTION
General
On
October 5, 2010, we entered into the Purchase Agreement, which provides that,
upon the terms and subject to the conditions and limitations set forth therein,
Lincoln Park is committed to purchase up to an aggregate of $10 million of our
shares of common stock over the term of the Purchase Agreement.
As of
November 12, 2010, there were 42,382,311 shares of our common stock outstanding
(37,498,384 shares held by non-affiliates) excluding the shares offered to
Lincoln Park pursuant to this prospectus. If all 12,336,538 shares of our common
stock offered hereby were issued and outstanding as of the date hereof, this
would represent approximately 23% of the total common stock outstanding or 25%
of the non-affiliate shares of common stock outstanding as of the date hereof.
The number of shares of our common stock ultimately offered for sale to Lincoln
Park is dependent upon the number of shares we elect to sell to Lincoln Park
under the Purchase Agreement.
Pursuant
to the Purchase Agreement, we filed a registration statement, of which this
prospectus is a part, with regard to the sale by Lincoln Park of the common
stock issuable under the Purchase Agreement. Under the Purchase Agreement, we
have the right but not the obligation to direct Lincoln Park to purchase up to
150,000 shares of common stock every other business day at a purchase price
calculated by reference to the prevailing market price of our common stock,
subject to the floor price of $0.30 per share. There are no trading volume
requirements or restrictions under the Purchase Agreement, and we will control
the timing and amount of any sales of our common stock to Lincoln Park. Our
ability to sell our shares to Lincoln Park is also subject to our obtaining all
necessary consents, amendments or waivers as may be required. Lincoln Park has
no right to require any sales by us, but is obligated to make purchases from us
as we direct in accordance with the Purchase Agreement. We can also accelerate
the amount of common stock to be purchased under certain circumstances. There
are no limitations on use of proceeds, financial or business covenants,
restrictions on future funding, rights of first refusal, participation rights,
penalties or liquidated damages in the Purchase Agreement. We did not pay any
expense reimbursement or placement agent fee in connection with the transaction.
The Purchase Agreement may be terminated by us at any time, at our discretion,
without any penalty or cost to us.
Purchase
of Shares Under The Purchase Agreement
Under the
Purchase Agreement, on any trading day selected by us, we may sell to Lincoln
Park up to 150,000 shares of our common stock by delivering a purchase notice to
Lincoln Park. The Purchase Price of such shares is equal to the lesser of: (i)
the lowest sale price of our common stock on the purchase date; or (ii) the
arithmetic average of the three lowest closing sale prices for our common stock
during the twelve consecutive trading days ending on the trading day immediately
preceding the purchase date. . In addition, we may accelerate the amounts of
purchases by an additional 150,000 shares of our common stock in the event the
Closing Price of our stock is not below $.75 per share on such day. The Purchase
Price of such accelerated amounts will be the lesser of (i) the lowest sale
price of our common stock on the purchase date and (ii) the lowest purchase
price (as described above) during the previous 10 business days prior to the
purchase date. The Purchase Price will be adjusted for any reorganization,
recapitalization, non-cash dividend, stock split, or other similar transaction
occurring during the trading day(s) used to compute the Purchase
Price.
In
consideration for entering into the Purchase Agreement, we issued to Lincoln
Park 305,944 restricted shares of common stock (not included in this offering)
as initial commitment shares and are required to issue up to 336,538 shares of
common stock (included in this offering) as additional commitment shares on a
pro rata basis as we require Lincoln Park to purchase shares under the Purchase
Agreement over the term. We can also accelerate the amount of common stock to be
purchased under certain circumstances. Our ability to sell shares to Lincoln
Park is subject to our obtaining all necessary consents, amendments or waivers
as may be required. The proceeds received by us under the Purchase Agreement are
expected to be used for debt service, working capital and general corporate
purposes.
24
Minimum
Purchase Price
Under the
Purchase Agreement, we have set a floor price of $.30 per share. However,
Lincoln Park shall not have the right nor the obligation to purchase any shares
of our common stock in the event that the purchase price per share would be less
than the floor price.
Compliance
with the NYSE Amex Continued Listing Requirements
Under the
terms of the Purchase Agreement, the securities to be issued to Lincoln Park may
not exceed 19.99% of our outstanding securities on the date of the Purchase
Agreement, unless and until our shareholders have approved such additional
shares, in the event such approval is required under the rules and regulations
of the trading market where our securities are then listed.
Events
of Default
The
Purchase Agreement contains a number of events constituting an “Event of
Default”, including:
|
·
|
while
any registration statement is required to be maintained effective pursuant
to the terms of the registration rights agreement between us and Lincoln
Park, the effectiveness of such registration statement lapses for any
reason (including, without limitation, the issuance of a stop order) or is
unavailable for sale of our shares of common stock in accordance with the
terms of the registration rights agreement, and such lapse or
unavailability continues for a period of ten consecutive business days or
for more than an aggregate of thirty business days in any 365-day
period;
|
|
·
|
the
suspension from trading or failure of our common stock to be listed on our
principal market for a period of three consecutive business
days;
|
|
·
|
the
delisting of our common stock from our principal market, provided our
common stock is not immediately thereafter trading on the OTC Bulletin
Board, the NASDAQ Global Market, the NASDAQ Global Select Market, the New
York Stock Exchange or the NASDAQ Capital
Market;
|
|
·
|
our
transfer agent’s failure to issue to Lincoln Park shares of our common
stock which Lincoln Park is entitled to receive under the Purchase
Agreement within five business days after an applicable purchase
date;
|
|
·
|
any
breach by us of the representations or warranties or covenants contained
in the Purchase Agreement or any related agreements which could have a
material adverse effect on us subject to a cure period of five business
days;
|
|
·
|
if
we become insolvent or are generally unable to pay our debts as they
become due; or
|
|
·
|
any
participation or threatened participation in insolvency or bankruptcy
proceedings by or against us.
|
Our
Termination Rights
The
Purchase Agreement may be terminated by us at any time, at our discretion,
without any cost to us.
No
Short-Selling or Hedging by Lincoln Park
Lincoln
Park has agreed that neither it nor any of its agents, representatives and
affiliates shall engage in any direct or indirect short-selling or hedging of
our common stock during the term of the Purchase Agreement.
25
Effect
of Performance of the Purchase Agreement on Our Shareholders
All
12,000,000 shares registered in this offering which may be sold by us to Lincoln
Park under the Purchase Agreement are expected to be freely tradable. It is
anticipated that shares registered in this offering will be sold over a period
of up to 25 months from the date of this prospectus. The sale by Lincoln Park of
a significant amount of shares registered in this offering at any given time
could cause the market price of our common stock to decline or to be highly
volatile. Lincoln Park may ultimately purchase all, some, or none of the common
stock offered pursuant to this prospectus. After it has acquired any of such
shares, it may sell all, some, or none of such shares. Therefore, sales to
Lincoln Park by us pursuant to the Purchase Agreement may result in substantial
dilution to the interests of other shareholders. However, we have the right to
control the timing and amount of any sales of our shares to Lincoln Park and the
Purchase Agreement may be terminated by us at any time at our discretion without
any cost to us.
In
connection with entering into the Purchase Agreement, we authorized the sale to
Lincoln Park of up to $10 million of our common stock exclusive of the 305,944
commitment shares issued, but not included in this offering, and the 336,538
additional commitment shares that may be issued and are part of this offering.
We have chosen to register in this offering 12,000,000 shares of our common
stock for purchase by Lincoln Park and the 336,538 additional commitment shares
to be issued on a pro rata basis as we require Lincoln Park to make purchases.
We have the right to terminate the agreement without any payment or liability to
Lincoln Park at any time, including in the event that all $10,000,000 is sold to
Lincoln Park under the Purchase Agreement. In the event we elect to issue more
than the 12,336,538 shares offered hereby, we will be required to file a new
registration statement and have it declared effective by the SEC. In addition,
in the event that we decide to issue more than 19.99% of our outstanding shares
of common stock as of the date of the Purchase Agreement, we would first be
required to seek shareholder approval in order to be in compliance with the NYSE
AMEX rules to the extent such rules are applicable to us at such time. The
number of shares ultimately offered for sale by Lincoln Park under this
prospectus is dependent upon the number of shares purchased by Lincoln Park
under the Purchase Agreement. The following table sets forth the amount of
proceeds we would receive from Lincoln Park from the sale of shares at varying
purchase prices:
Assumed Average
Purchase Price
($)
|
Number of Registered
Shares to be Issued if
Full Purchase (1)(2)
|
Percentage of
Outstanding
Shares After Giving
Effect to the
Issuance to Lincoln
Park(3)
|
Additional Proceeds from
the Sale of
Registered Shares
to Lincoln Park Under the
Purchase Agreement
($)
|
||||||||||
$ |
.30
|
(4) |
12,220,279
|
22.38
|
% | $ |
3,600,000
|
||||||
$ |
.51
|
(5) |
12,336,538
|
|
22.55
|
% | $ |
6,120,000
|
|||||
$ |
.75
|
12,336,538
|
22.55
|
% | $ |
9,000,000
|
|||||||
$ |
1.25
|
8,336,538
|
16.44
|
% | $ |
10,000,000
|
|||||||
$ |
2.00
|
5,336,538
|
11.18
|
% | $ |
10,000,000
|
|
(1)
|
Although
the Purchase Agreement provides that we may sell up to $10,000,000 of our
common stock to Lincoln Park, we are only registering 12,000,000 shares to
be purchased thereunder, which may or may not cover all such shares
purchased by them under the Purchase Agreement, depending on the purchase
price per share. As a result, we have included in this column only those
shares which are registered in this offering.
|
|
(2)
|
The
number of registered shares to be issued includes the additional
commitment shares issuable to Lincoln Park (but not the initial commitment
shares), and no proceeds will be attributable to such commitment
shares.
|
|
(3)
|
The
denominator is based 42,382,311 shares outstanding as of November 12,
2010, and includes the 1,000,000 shares already owned by Lincoln Park not
included in this offering, and the number of shares set forth in the
adjacent column which includes the commitment shares issued pro rata if up
to $10,000,000 of our stock is purchased by Lincoln Park. The numerator is
based on the number of shares issuable under the Purchase Agreement at the
corresponding assumed purchase price set forth in the adjacent column. In
the event we decide to issue more than 19.99% of our outstanding shares of
common stock as of the date of the Purchase Agreement, we would first be
required to seek shareholder approval in order to be in compliance with
the NYSE AMEX rules, to the extent applicable.
|
|
(4)
|
Under
the Purchase Agreement, we may not sell and Lincoln Park cannot purchase
any shares in the event the price of our stock is below
$.30.
|
|
(5)
|
The
closing price of our common stock was $.51 on November 12,
2010.
|
26
INCORPORATION
BY REFERENCE
The SEC
allows us to “incorporate by reference” information in this prospectus that we
have filed with it. This means that we can disclose important information to you
by referring you to another document already on file with the SEC. The
information incorporated by reference is an important part of this prospectus,
except for any information that is superseded by information that is included
directly in this prospectus.
We
incorporate by reference the documents listed below, other than information that
is “furnished” but deemed by the rules of the SEC not to have been
“filed”:
|
§
|
our
Annual Report on Form 10-K for the year ended December 31, 2009, filed
with the SEC on March 29, 2010, and our annual report on Form 10-K/A for
the year ended December 31, 2009, filed with the SEC on April 4,
2010;
|
|
§
|
our
definitive proxy statement on Schedule 14A, relating to the Annual
Shareholder Meeting held on October 1, 2010 as filed with the SEC on
August 25, 2010;
|
|
§
|
our
Quarterly Reports on Form 10-Q for the quarters ended September 30, June
30 and March 31, 2010, respectively,
and;
|
|
§
|
our
Current Reports on Form 8-K filed with the SEC (excluding any information
which is furnished and not filed with the SEC) on April 12, 2010 (as
subsequently amended and supplemented by our Current Report on Form 8-K/A
(Amendment No.1, Amendment No. 2 and Amendment No. 3 filed on June 21,
August 3 and November 16, 2010 respectively)), July 1, 2010, October 1 and
8, 2010, and November 19, 2010.
|
We will
provide to each person, including any beneficial owner, to whom a prospectus is
delivered, upon written or oral request, a copy of the reports and documents
that have been incorporated by reference in this prospectus, at no cost. Any
such request may be made by writing or telephoning us at the following address
or phone number:
Cytomedix,
Inc.
Attn:
Chief Financial Officer
209 Perry
Parkway, Suite 7
Gaithersburg,
MD 20877
(240)
499-2680
These
documents can also be requested through, and are available in, the “Investors”
section of our website, which is located at www.cytomedix.com, or as
described under the “Investors” and “SEC Filings” section of the website. The information and other content
contained on or linked from our website are not part of this
prospectus.
This
prospectus or information incorporated by reference herein contains summaries of
certain agreements that we have filed as exhibits to our various SEC filings.
The descriptions of these agreements contained in this prospectus or information
incorporated by reference herein do not purport to be complete and are subject
to, or qualified in their entirety by reference to, the definitive agreements.
Copies of the definitive agreements will be made available without charge to you
by making a written or oral request to us in the manner specified
above.
27
LEGAL
MATTERS
The
validity of the common stock offered by this prospectus has been passed upon for
us by Cozen O’Connor, Washington, D.C.
EXPERTS
The
financial statements incorporated in this registration statement by reference to
the Annual Report on Form 10-K/A for the year ended December 31, 2009 have been
so incorporated in reliance on the report (which contains an explanatory
paragraph relating to the Company's ability to continue as a going concern as
described in Note 2 to the financial statements) of PricewaterhouseCoopers LLP,
an independent registered public accounting firm, given on the authority of said
firm as experts in auditing and accounting.
MaloneBailey
LLP, an independent public accounting firm, audited certain combined Statements
of Net Assets Acquired and Liabilities Assumed of the Angel Business of Sorin
Group USA, Inc. as of December 31, 2009 and 2008, and the related combined
Statements of Revenues and Direct Expenses for the years then ended, included in
our Current Report on Form 8-K dated April 9, 2010, set forth in their report
which has been incorporated by reference, and is included in reliance upon such
report given on the authority of such firm as experts in accounting and
auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We have
filed with the SEC a registration statement on Form S-1 under the Securities Act
with respect to the common stock offered in this offering. This prospectus does
not contain all of the information set forth in the registration statement. For
further information with respect to us and the common stock offered in this
offering, we refer you to the registration statement and to the attached
exhibits. With respect to each such document filed as an exhibit to the
registration statement, we refer you to the exhibit for a more complete
description of the matters involved.
You may
inspect our registration statement and the attached exhibits and schedules
without charge at the public reference facilities maintained by the SEC at 100 F
Street, N.E., Washington, D.C. 20549. You may obtain copies of all or any part
of our registration statement from the SEC upon payment of prescribed fees. You
may obtain information on the operation of the public reference room by calling
the SEC at 1-800-SEC-0330.
Our SEC
filings, including the registration statement and the exhibits filed with the
registration statement, are also available from the SEC's website at
www.sec.gov, which contains reports, proxy and information statements and other
information regarding issuers that file electronically with the
SEC.
28
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
13. Other Expenses of Issuance and Distribution
The
following table sets forth the costs and expenses, other than underwriting
discounts, payable by the registrant in connection with the sale of the shares
of common stock being registered. All amounts are estimates except the fees
payable to the SEC.
SEC
registration fee
|
$ | 567.48 | ||
Accounting
fees and expenses*
|
$ | 5,000 | ||
Legal
fees and expenses*
|
$ | 30,000 | ||
Total
|
$ | 35,567.48 |
*Estimates
Item
14. Indemnification of Directors and Officers
Generally
speaking, Section 145 of the Delaware General Corporation Law permits a
corporation to indemnify any person who might be a party to an action by reason
of the fact that the person is or was a director, officer, employee or agent of
the corporation if the person acted in good faith and in a manner reasonably
believed to be in or not opposed to the best interests of the corporation, and,
with respect to any criminal action or proceeding, had no reasonable cause to
believe his conduct was unlawful.
Article
10 of our Amended and Restated Certificate of Incorporation provides that our
directors shall not be personally liable to us or our shareholders for monetary
damages for breach of fiduciary duty as a director except for liability (i) for
any breach of the director's duty of loyalty to us or our shareholders, (ii) for
acts or omissions not in good faith or which involve intentional misconduct or a
knowing violation of law, (iii) under Section 174 of the Delaware General
Corporation Law, or (iv) for any transaction from which the director derived any
improper personal benefit.
Further,
Article VIII of our Restated Bylaws provides generally that we shall indemnify
any person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action, suit or proceeding, whether civil,
criminal, administrative or investigative (other than an action by or in the
right of Cytomedix) by reason of the fact that he is or was a director, officer,
employee or agent of Cytomedix, or is or was serving at our request as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise, against expenses (including attorneys'
fees), judgments, fines and amounts paid in settlement actually and reasonably
incurred by him in connection with such action, suit or proceeding if he acted
in good faith and in a manner he reasonably believed to be in or not opposed to
our best interests, and, with respect to any criminal action or proceeding, had
no reasonable cause to believe his conduct was unlawful. To the extent that a
director, officer, employee or agent of Cytomedix has been successful on the
merits or otherwise in defense of any action, suit or proceeding referred to
above, he shall be indemnified against expenses (including attorneys' fees)
actually and reasonably incurred by him in connection therewith. No
indemnification shall be made in respect of any claim, issue or matter as to
which such person shall have been adjudged to be liable to us unless and only to
the extent that the court in which such action or suit was brought shall
determine upon application that, despite the adjudication of liability but in
view of all the circumstances of the case, such person is fairly and reasonably
entitled to indemnity for such expenses which the court shall deem proper. The
indemnification and advancement of expenses provided by, or granted pursuant to,
our Restated Bylaws shall not be deemed exclusive of any other rights to which
those seeking indemnification or advancement of expenses may be entitled under
any bylaw, agreement, vote of shareholders or disinterested directors or
otherwise, both as to action in his official capacity and as to action in
another capacity while holding such office.
Furthermore,
our Restated Bylaws provide that we have the power to purchase and maintain
insurance on behalf of any person who is or was a director, officer, employee or
agent of Cytomedix, or is or was serving at our request as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust or
other enterprise against any liability asserted against him and incurred by him
in any such capacity, or arising out of his status as such, whether or not we
would have the power to indemnify him against such liability under the
provisions of the Restated Bylaws.
II-1
Item
15. Recent Sales of Unregistered Securities
On April
9, 2010, the Company sold in a private placement with certain accredited
investors (i) 10% Series D convertible preferred stock, and (ii) warrants to
purchase shares of common stock of the Company for gross proceeds of $3.65
million. The Company agreed to register the resale of certain securities sold in
this private placement. All purchasers in this offering were “accredited
investors” (as such term is defined in Rule 501(a) of Regulation D under the
Securities Act, and the Company sold the securities in the offering in reliance
upon an exemption from registration contained in Section 4(2) and Rule 506 under
the Securities Act.
In
October 2010, in consideration for entering into the Purchase Agreement, the
Company issued to Lincoln Park 305,944 shares of common stock. Lincoln Park, the
sole purchaser in connection with the Purchase Agreement, was an “accredited
investor” (as such term is defined in Rule 501(a) of Regulation D under the
Securities Act, and the Company sold the securities in reliance upon an
exemption from registration contained in Section 4(2) and Rule 506 under the
Securities Act. The securities sold may not be offered or sold in the United
States absent registration or an applicable exemption from registration
requirements.
Item
16. Exhibits and Financial Statement Schedules
(a) Exhibits
pursuant to Item 601 of Regulation S-K
2.1
|
Asset
Purchase Agreement by and among Sorin Group USA, Inc., Cytomedix
Acquisition Company and Cytomedix, Inc, dated as of April 9, 2010
(Previously filed on April 12, 2010 as an exhibit to the Current Report on
Form 8-K, File No. 001-32518 and is incorporated by reference
herein).
|
3(i)(1)
|
Amendment
to Restated Certificate of Incorporation of Cytomedix, Inc. (Previously
filed on November 15, 2004, as exhibit to Form 10-QSB for quarter ended
September 30, 2004, File No. 000-28443, and incorporated by reference
herein).
|
3(i)(2)
|
Certificate
of Amendment to the Certificate of Incorporation (Previously filed on July
1, 2010 as exhibit to the Current Report on Form 8-K, File no. 001-32518,
and incorporated by reference herein).
|
3(ii)
|
Restated
Bylaws of Cytomedix, Inc. (Previously filed on November 7, 2002, as
exhibit to Form 10-QSB for quarter ended June 30, 2001, File No.
000-28443, and incorporated by reference herein).
|
4.1
|
Amended
and Restated Certificate of Designation of the Relative Rights and
Preferences of Series A Preferred, Series B Preferred and common stock of
Cytomedix, Inc. (Previously filed on March 31, 2004, on Form 10-KSB for
year ended December 31, 2003, File No. 000-28443 and is incorporated by
reference herein).
|
4.2
|
Certificate
of Designation of the Relative Rights and Preferences of the Series C
Convertible Preferred Stock of Cytomedix, Inc. (Previously filed on March
29, 2004 on Form 8-K, File No. 000-28443 and is incorporated by reference
herein).
|
4.3
|
Form
of Warrant (Previously filed on April 12, 2010 as an exhibit to the
Current Report on Form 8-K, File No. 001-32518 and is incorporated by
reference herein).
|
4.4
|
Certificate
of Designation, Relative Rights and Preferences of the 10% Series D
Convertible Preferred Stock. (Previously filed on April 12, 2010 as an
exhibit to the Current Report on Form 8-K, File No. 001-32518 and is
incorporated by reference
herein).
|
II-2
5.1
|
Cozen
O’Connor Opinion *
|
10.1
|
Form
of the Purchase Agreement (Previously filed on October 8, 2010 on Form
8-K, File No. 001-32518 and is incorporated by reference
herein).
|
10.2
|
Form
of the Registration Rights Agreement (Previously filed on October 8, 2010
on Form 8-K, File No. 001-32518 and is incorporated by reference
herein).
|
10.3
|
Royalty
Agreement, dated as of December 26, 2000, by and between Cytomedix, Inc.
and Curative Health Services, Inc. (Previously filed on January 17, 2001,
as exhibit to Current Report on Form 8-K, File No.
000-28443).
|
10.4
|
First
Amendment to Royalty Agreement, dated as of April 20, 2001, by and between
Cytomedix, Inc. and Curative Health Services, Inc. (Previously filed on
May 25, 2001, as exhibit to the registration statement on Form SB-2/A,
File No. 333-55818).
|
10.5
|
Second
Amendment to Royalty Agreement, dated as of December 5, 2002, by and
between Cytomedix, Inc. and Curative Health Services, Inc. (Previously
filed on March 31, 2003, as exhibit to Form 10-KSB for year ended December
31, 2002, File No. 000-28443).
|
10.6
|
Cytomedix,
Inc. Long-Term Incentive Plan. (Previously filed on February 26, 2007, on
Form 10-K for year ended December 31, 2006, File No.
001-32518).**
|
10.7
|
License
Agreement dated March 21, 2001, by and between Cytomedix, Inc. and DePuy
AcroMed, Inc. (Previously filed on April 16, 2001, as exhibit to Form
10-KSB for year ended December 31, 2000, File No.
000-28443).
|
10.8
|
Amendment
dated March 3, 2005, to the License Agreement by and between Cytomedix,
Inc. and DePuy Spine, Inc. (f/k/a DePuy Acromed, Inc.) (Previously filed
on March 31, 2005, as exhibit to Form 10-KSB for year ended December 31,
2004, File No. 000-28443).
|
10.9
|
Second
License Agreement dated March 3, 2005, to the License Agreement by and
between Cytomedix, Inc. and DePuy Spine, Inc. (f/k/a DePuy Acromed, Inc.)
(Previously filed on March 31, 2005, as exhibit to Form 10-KSB for year
ended December 31, 2004, File No. 000-28443).
|
10.10
|
Settlement
and License Agreement dated May 1, 2005 by and between Cytomedix, Inc. and
Medtronic, Inc. (Previously filed on May 10, 2005, as exhibit to Current
Report on Form 8-K, File No. 000-28443).
|
10.11
|
Settlement
Agreement and License Agreement dated May 23, 2005, by and between
Cytomedix, Inc., and Harvest Technologies Corporation (Previously filed on
May 27, 2005, as exhibit to Current Report on Form 8-K, File No.
000-28443).
|
10.12
|
Settlement
and License Agreement dated June 26, 2005, by and between Cytomedix, Inc.,
and Perfusion Partners and Associates Inc. (Previously filed on August 15,
2005, as exhibit to Form 10-QSB for the quarter ended June 20, 2005, File
No. 000-28443).
|
10.13
|
License
Agreement dated October 7, 2005, by and between Cytomedix, Inc., and COBE
Cardiovascular, Inc. (Previously filed on October 11, 2005, as exhibit to
Current Report on Form 8-K, File No.
000-28443).
|
II-3
10.14
|
Settlement
and License Agreement dated October 12, 2005, by and between Cytomedix,
Inc., and SafeBlood Technologies, Inc. (Previously filed on November 9,
2005, as exhibit to Form 10-QSB, File No. 000-28443).
|
10.15
|
Employment
Agreement with Ms. Carelyn P. Fylling (Previously filed on December 5,
2002, as exhibit to Form 10-QSB for quarter ended September 30, 2001, File
No. 000-28443).**
|
10.16
|
Employment
Agreement with Kshitij Mohan, Ph.D., dated April 20, 2004 (Previously
filed on May 7, 2004, on Current Report on Form 8-K, File No.
00028443).**
|
10.17
|
Termination
Agreement between Cytomedix, Inc., and Kshitij Mohan, dated April 20, 2004
(Previously filed on May 7, 2004, as exhibit to Current Report on Form
8-K, File No. 000-28443).**
|
10.18
|
Employment
Agreement dated June 3, 2005, by and between Cytomedix, Inc., and Andrew
Maslan (Previously filed on June 20, 2005, as exhibit to Current Report on
Form 8-K, File No. 000-28443).**
|
10.19
|
Distributor
Agreement dated October 31, 2005 by and between Cytomedix, Inc. and
National Wound Therapies, LLC. (Previously filed on March 23, 2006, as
exhibit to Form 10-KSB, File No. 001-32518).
|
10.20
|
Settlement
and License Agreement dated May 19, 2006, between Cytomedix, Inc., and
Biomet Biologics, Inc. (Previously filed on August 9, 2006, as exhibit to
Form 10-Q, File No. 001-32518).
|
10.21
|
First
Addendum to Letter Agreement dated October 4, 2006, between Cytomedix,
Inc., and Andrew Maslan (Previously filed on November 1, 2006 as exhibit
to Form 10-Q, File No. 001-32518).**
|
10.22
|
License
Agreement between Cytomedix, Inc., and Smith & Nephew, Inc.
(Previously filed on October 15, 2007 as exhibit to Current Report on Form
8-K, File No 001-32518).
|
10.23
|
First
Amendment to Employment Agreement by and between the Company and Kshitij
Mohan (previously filed on January 29, 2008 as exhibit to Current Report
on Form 8-K, File No. 001-32518).**
|
10.24
|
Letter
Agreement by and between the Company and Martin Rosendale, dated as of
March 14, 2008 (previously filed on March 17, 2008 as exhibit to Current
Report on Form 8-K, File No. 001-32518).**
|
10.25
|
Kshitij
Mohan Termination and Consulting Agreement (previously filed on June 10,
2008 as exhibit to Current Report on Form 8-K, File No.
001-32518).**
|
10.26
|
Amendment
to the Purchase Agreement between the Company and Lincoln Park Capital
Fund LLC dated as of November 4, 2010(1)
|
23.1
|
Consent
of Pricewaterhouse Coopers LLP(1)
|
23.2
|
Consent
of MaloneBailey LLP(1)
|
23.3
|
Consent
of Cozen O’Connor (included in Exhibit
5.1)
|
II-4
24.1
|
Power
of Attorney (included on signature
page)
|
*
|
Filed
herewith
|
**
|
Indicates
a management contract or compensatory plan or
arrangement.
|
(1) Previously
filed as Exhibit to this Registration Statement on Form S-1 filed with the
Commission on November 19, 2010 (SEC File No. 333-170747).
Item
17. Undertakings
(a)
The undersigned registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) To
include any prospectus required by Section 10(a)(3) of the Securities Act of
1933;
(ii) To
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding the
foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than a 20 percent change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in the
effective registration statement; and
(iii) To
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement.
(2) That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
(3) To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
(4) That,
for the purpose of determining liability under the Securities Act of 1933 to any
purchaser:
(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
II-5
(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 of
1933 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.
(5) That,
for the purpose of determining liability of the registrant under the Securities
Act of 1933 to any purchaser in the initial distribution of the securities, in a
primary offering of securities of the undersigned registrant pursuant to this
registration statement, regardless of the underwriting method used to sell the
securities to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the undersigned
registrant will be a seller to the purchaser and will be considered to offer or
sell such securities to such purchaser:
(i) Any
preliminary prospectus or prospectus of the undersigned registrant relating to
the offering required to be filed pursuant to Rule 424;
(ii) Any
free writing prospectus relating to the offering prepared by or on behalf of the
undersigned registrant or used or referred to by the undersigned
registrant;
(iii) The
portion of any other free writing prospectus relating to the offering containing
material information about the undersigned registrant or its securities provided
by or on behalf of the undersigned registrant; and
(iv) Any
other communication that is an offer in the offering made by the undersigned
registrant to the purchaser.
(b) 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 such indemnification is against public
policy as expressed in the Securities Act and is, therefore, unenforceable. In
the event that a claim for indemnification against such liabilities (other than
a payment by the registrant of expenses incurred or paid by a director, officer
or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act and will be governed by the final adjudication of such
issue.
II-6
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant has duly
caused this registration statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in Gaithersburg, Maryland, on December
6, 2010.
CYTOMEDIX,
INC.
|
|
By:
|
/s/ Martin P. Rosendale
|
Name:
|
Martin
P. Rosendale
|
Title:
|
Chief
Executive Officer (Principal Executive
Officer)
|
Pursuant
to the requirements of the Securities Act of 1933, this registration statement
has been signed by the following persons in the capacities and on the dates
indicated:
Signature
|
Title
|
Date
|
||
/s/
Martin P. Rosendale
|
Chief
Executive Officer (Principal
|
December
6, 2010
|
||
Martin
P. Rosendale
|
Executive
Officer) and Director
|
|||
/s/
Andrew S. Maslan
|
Chief
Financial Officer (Principal
|
December
6, 2010
|
||
Andrew
S. Maslan
|
Accounting
Officer)
|
|||
/s/
*
|
Director
|
December
6, 2010
|
||
Stephen
N. Keith
|
||||
/s/
*
|
Director
|
December
6, 2010
|
||
Craig
B. Mendelsohn
|
||||
/s/
*
|
Director
|
December
6, 2010
|
||
David
E. Jorden
|
||||
/s/
*
|
Director
|
December
6, 2010
|
||
James
S. Benson
|
||||
/s/
*
|
Director
|
December
6, 2010
|
||
Mark
T. McLoughlin
|
||||
/s/
*
|
Director
|
December
6, 2010
|
||
C.
Eric Winzer
|
*By: |
/s/
Martin
P. Rosendale
|
|
|||
Martin
P. Rosendale
|
|
||||
Attorney-in-
fact
|
|
II-7