Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
SB-2
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Arbios
Systems, Inc.
(Name
of
Small Business Issuer in its Charter)
Delaware
|
3841
|
91-1955323
|
(State
or jurisdiction of
incorporation
or organization)
|
(Primary
Standard Industrial
Classification
Code Number)
|
(I.R.S.
Employer
Identification
No.)
|
8797
Beverly Blvd., Suite 304
Los
Angeles, California 90048
(310)
657-4898
(Address
and telephone number of principal executive offices and principal place of
business)
Walter
C. Ogier
President
and Chief Executive Officer
8797
Beverly Blvd., Suite 304
Los
Angeles, California 90048
(310)
657-4898
(Name,
address and telephone number of agent for service)
Copy
to:
William
T. Whelan, Esq.
Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
One
Financial Center
Boston,
Massachusetts 02111
(617)
542-6000
Approximate
date of proposed sale to the public: From time to time after the date this
registration statement becomes effective.
If
this
Form is filed to register additional securities for an offering pursuant to
Rule
462(b) under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. o
If
this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
If
this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
If
delivery of the prospectus is expected to be made pursuant to Rule 434, check
the following box. o
|
|
CALCULATION
OF REGISTRATION FEE
|
|
Title
of each class of securities to
be
registered
|
|
Amount
to be
registered
|
|
Proposed
maximum
offering
price
per
unit(1)
|
|
Proposed
maximum
aggregate
offering
price(1)
|
|
Amount
of
registration
fee(1)
|
|
Common
stock, par value $0.001
|
|
|
1,840,906
(2
|
)
|
$
|
1.08
|
|
$
|
1,988,178
|
|
$
|
212.74
|
|
___________________
|
|
(1)
|
The
price is estimated in accordance with Rule 457(c) under the Securities
Act
of 1933, as amended, solely for the purpose of calculating the
registration fee and represents the average of the bid and asked
prices of the Common Stock on April 24, 2006, as reported on the
OTC
Bulletin Board.
|
(2)
|
Of
these shares, 1,227,272 are currently outstanding shares to be offered
for
resale by selling stockholders and 613,634 shares are currently unissued
shares to be offered for resale by selling stockholders following
issuance
upon exercise of outstanding warrants. In addition to the shares
set forth
in the table, the amount to be registered includes an indeterminate
number
of shares issuable upon exercise of the warrants, as such number
may be
adjusted as a result of stock splits, stock dividends and similar
transactions in accordance with Rule 416.
|
|
|
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.
The
information in this prospectus is not complete and may be changed. We may not
sell these securities until the registration statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell
these securities and it is not soliciting an offer to buy these securities
in
any state where the offer or sale is not permitted.
PROSPECTUS
ARBIOS
SYSTEMS, INC.
1,840,906
Shares of Common Stock
This
prospectus relates to the sale or other disposition of up to 1,227,272 shares
of
our currently outstanding shares of common stock that are owned by some of
our
stockholders, and 613,634 shares of our common stock issuable upon the exercise
of currently outstanding common stock purchase warrants held by some of our
stockholders. For a list of the selling stockholders, please refer to the
"Selling Stockholders" section of this prospectus. We are not selling any shares
of common stock in this offering and therefore will not receive any proceeds
from this offering. We will, however, receive the exercise price of the warrants
if and when those warrants are exercised by the selling stockholders. None
of
the warrants has been exercised as of the date of this prospectus. We will
pay
the expenses of registering these shares.
Our
common stock is traded in the over-the-counter market and is quoted on the
OTC
Bulletin Board under the symbol ABOS. On April 26, 2006, the closing price
of
our common stock was $1.05 per share.
The
shares included in this prospectus may be disposed of on any stock exchange,
market or trading facility on which the shares are traded or in private
transactions. These dispositions may be at fixed prices, at prevailing market
prices at the time of sale, at prices related to the prevailing market price,
at
varying prices determined at the time of sale, or at negotiated prices. We
will
not control or determine the price at which a selling stockholder decides to
sell or otherwise dispose of its shares. Brokers or dealers effecting
transactions in these shares should confirm that the shares are registered
under
applicable state law or that an exemption from registration is available.
You
should understand the risks associated with investing in our common stock.
Before making an investment, please read the “Risk Factors” section of this
prospectus, which begins on page 4.
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or passed upon the adequacy or
accuracy of the prospectus. Any representation to the contrary is a criminal
offense.
The
date
of this prospectus is ,
2006.
TABLE
OF
CONTENTS
Page
Prospectus
Summary
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1
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Risk
Factors
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4
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Forward-Looking
Statements
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16
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Use
of Proceeds
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16
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Market
Price of Common Stock and Other Shareholder Matters
|
17
|
Management’s
Discussion and Analysis or Plan of Operation
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19
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Business
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25
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Directors,
Executive Officers, Promoters and Control Persons
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46
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Executive
Compensation
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51
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Security
Ownership of Certain Beneficial Owners and Management
|
56
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Selling
Stockholders
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60
|
Plan
of Distribution
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62
|
Certain
Relationships and Related Transactions
|
65
|
Description
of Securities
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67
|
Interests
of Named Experts and Counsel
|
71
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Disclosure
of Commission Position on Indemnification for Securities Act
Liabilities
|
71
|
Legal
Matters
|
72
|
Where
You Can Find More Information
|
72
|
Index
to Financial Statements
|
F-1
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PROSPECTUS
SUMMARY
This
summary highlights information contained elsewhere in this prospectus; it does
not contain all of the information you should consider before investing in
our
common stock. Read the entire prospectus before making an investment
decision.
Throughout
this prospectus, the terms “we,” “us,” “our,” and “our company” refer to Arbios
Systems, Inc., a Delaware corporation.
A
glossary of certain terms used in this prospectus is contained on page 44 under
“Glossary of Terms.”
Company
Overview
Arbios
Systems, Inc., or Arbios, is a Delaware corporation based in Los Angeles,
California. We seek to develop, manufacture and market liver assist therapies
to
meet the urgent need for medical treatment of liver failure.
We
are a
medical device and cell therapy company that is focusing on the development
of
products for the treatment of liver failure. Our lead products under development
currently consist of a novel extracorporeal blood purification therapy called
the SEPET™ Liver Assist Device and an extracorporeal, bioartificial liver
therapy referred to as the HepatAssist-2™ Bioartificial Liver System that
incorporate porcine pig liver cells. We also have rights and a licensing
agreement to the LIVERAID™ Bioartificial Liver System, which is a potential
enhancement to HepatAssist-2™, but development of that system is on an
indefinite hold. We currently own seven key U.S. patents and are the licensee
of
seven other U.S. patents, as well as the owner of a patent application and
numerous related trade secrets.
In
April
2005, we received permission from the United States Food and Drug
Administration, or the FDA, to commence a 15-patient feasibility clinical study
of our SEPET™ cartridge. The enrollment of patients for the clinical trial has
been slower than we anticipated; however, the FDA has granted us permission
for
additional clinical sites to participate in the clinical trial. We currently
have three clinical sites enrolling patients and we have broadened the patient
eligibility criteria to expedite patient accrual. Our HepatAssist-2™
Bioartificial Liver System is an enhanced version of a system referred to as
HepatAssist® which we acquired from another company, Circe Biomedical, Inc., and
which has been tested in Phase II/III clinical trials. We have an active Phase
III investigational new drug application, or IND, to conduct additional clinical
trials using HepatAssist™ and intend to focus on introducing this important
liver assist technology into clinical practice. Because of the high cost and
technological difficulties in the manufacture of LIVERAID™ devices, we have
decided to stop the development of the LIVERAID™ Bioartificial Liver System
indefinitely. This decision allows us to allocate our financial and
organizational resources to the development of the SEPET™ and HepatAssist-2™
technologies.
Company
History.
Arbios
Systems, Inc. was originally incorporated in February 1999 as Historical
Autographs U.S.A., Inc., or HAUSA. Until October 2003, HAUSA was an e-commerce
based company engaged in the business of acquiring and marketing historical
documents. On October 30, 2003, HAUSA completed a reorganization (the
“Reorganization”) in which HAUSA, through its wholly-owned subsidiary, acquired
all of the outstanding shares of Arbios Technologies, Inc., or ATI, in exchange
for 11,930,598 shares of HAUSA common stock. As a result of the Reorganization,
ATI became the wholly-owned subsidiary of HAUSA. After the Reorganization,
HAUSA
changed its name to “Arbios Systems, Inc.,” replaced its officers and directors
with those of ATI, closed its offices, ceased its e-commerce business, and
moved
its offices to Los Angeles, California. On July 25, 2005, Arbios Systems, Inc.
completed its reincorporation as a Delaware corporation by merging with and
into
Arbios Systems, Inc., a Delaware corporation. The foregoing merger was approved
by the Company’s stockholders at the annual meeting of stockholders held on July
7, 2005. In order to consolidate the functions and operations of Arbios and
ATI,
on July 26, 2005, ATI merged into Arbios. As a result, Arbios now owns all
of
the assets of ATI and all of the operations of the two companies have been
consolidated into Arbios.
Our
principal operations and executive offices are located at 8797 Beverly Blvd.,
Suite 304, Los Angeles, California 90048 and our telephone number is (310)
657-4898. We also maintain corporate offices at 1050 Winter Street, Suite 1000,
Waltham, Massachusetts 02451 and a manufacturing facility based in Connecticut.
We also maintain a web site at www.arbios.com.
The
information on our web site is not, and you must not consider such information
to be, a part of this filing.
Recent
Developments
On
March
6, 2006, we announced that we have signed binding agreements and closed a
private placement financing of Units, consisting of common stock and warrants,
for gross proceeds of $1.35 million. Each Unit consists of one share of Arbios
common stock and one warrant to purchase 0.50 of a share of Arbios common stock,
comprising a total of 1,227,272 shares of Arbios common stock and warrants
to
purchase 613,634 shares of Arbios common stock. The Units were sold at a price
of $1.10 per Unit, and the warrants will be exercisable for a period of five
years at a price of $1.50 per share. The offering was made to accredited
investors, as defined in applicable SEC regulations. Participating in the
financing were current investors, including several funds managed by LibertyView
Capital Management (a division of Neuberger Berman, LLC, a Lehman Brothers
company) as well as Bristol Investment Fund, Ltd. (advised by Bristol Capital
Advisors, LLC), and a new, individual investor. The
proceeds of the private equity financing will be used to fund our general
working capital needs and the further development of our products. This
prospectus is part of the registration statement that we filed as a result
of
our agreement to register for resale under the Securities Act both the shares
of
common stock sold in that offering and the shares of common stock issuable
upon
exercise of the warrants sold in the financing.
The
Offering
Common
stock covered hereby
|
1,840,906
shares, consisting of 1,227,272 outstanding shares owned by selling
stockholders and 613,634 shares issuable to selling stockholders
upon
exercise of outstanding warrants.
|
|
|
Common
stock currently outstanding
|
17,460,181
shares (1)
|
|
|
Common
stock to be outstanding assuming
the
sale of all shares covered hereby and
assuming
no exercise of the warrants for
the
shares covered by this prospectus
|
17,460,181
shares (1)
|
|
|
Common
stock to be outstanding assuming
the
sale of all shares covered hereby and
assuming
the exercise of all warrants for
the
shares covered by this prospectus
|
18,073,815
shares (1)
|
|
|
OTC
Bulletin Board Trading Symbol
|
ABOS
|
|
|
Risk
Factors
|
An
investment in our common stock involves significant risks. See
“Risk
Factors” beginning on page 4.
|
(1)
In
addition to these outstanding shares of common stock, as of April 17, 2006,
there were outstanding (i) options to purchase 2,115,000 shares of our common
stock (with exercise prices ranging from $0.15 per share to $3.40 per share),
and (ii) warrants (other than the warrants owned by the selling stockholders)
to
purchase 7,551,843 shares of our common stock (with exercise prices ranging
from
$0.15 per share to $3.50 per share).
RISK
FACTORS
An
investment in our common stock involves a high degree of risk. You should
carefully consider the risks described below and the other information contained
in this prospectus and in the documents incorporated by reference before
deciding to invest in our company. If any of the following risks actually occur,
our business, financial condition or operating results and the trading price
or
value of our securities could be materially adversely affected.
We
are an early-stage company subject to all of the risks and uncertainties of
a
new business, including the risk that we may never market any products or
generate revenues.
We
are an
early-stage company that has not generated any operating revenues to date (our
only revenues were derived from two government research grants). Accordingly,
while we have been in existence since February 1999, and ATI, our operating
subsidiary, has been in existence since 2000, we should be evaluated as an
early-stage company, subject to all of the risks and uncertainties normally
associated with an early-stage company. As an early-stage company, we expect
to
incur significant operating losses for the foreseeable future, and there can
be
no assurance that we will be able to validate and market products in the future
that will generate revenues or that any revenues generated will be sufficient
for us to become profitable or thereafter maintain profitability.
We
have had no product sales to date, and we can give no assurance that there
will
ever be any sales in the future.
All
of
our products are still in research or development, and no revenues have been
generated to date from product sales. There is no guarantee that we will ever
develop commercially viable products. To become profitable, we will have to
successfully develop, obtain regulatory approval for, produce, market and sell
our products. There can be no assurance that our product development efforts
will be successfully completed, that we will be able to obtain all required
regulatory approvals, that we will be able to manufacture our products at an
acceptable cost and with acceptable quality, or that our products can be
successfully marketed in the future. We currently do not expect to receive
significant revenues from the sale of any of our products for at least the
next
three years.
Before
we can market any of our products, we must obtain governmental approval for
each
of our products, the application and receipt of which is time-consuming, costly
and uncertain.
The
development, production and marketing of our products are subject to extensive
regulation by government authorities in the United States and other countries.
In the United States, our SEPET™ Liver Assist Device and our
HepatAssist-2TM
Bioartificial Liver System will require approval from the FDA prior to clinical
testing and commercialization. The process for obtaining FDA approval to market
therapeutic products is both time-consuming and costly, with no certainty of
a
successful outcome. This process includes the conduct of extensive pre-clinical
and clinical testing, which may take longer or cost more than we currently
anticipate due to numerous factors, including, without limitation, difficulty
in
securing centers to conduct trials, difficulty in enrolling patients in
conformity with required protocols and/or projected timelines, unexpected
adverse reactions by patients in the trials to our liver assist systems,
temporary suspension and/or complete ban on trials of our products due to the
risk of transmitting pathogens from the xenogeneic biologic component, and
changes in the FDA’s requirements for our testing during the course of that
testing. For example, the enrollment of patients for our 15-patient feasibility
clinical study of our SEPETTM
cartridge has been slower than we anticipated. We have not yet established
with
the FDA the nature and number of clinical trials that the FDA will require
in
connection with its review and approval of either SEPET™ or our
HepatAssist-2TM
products
and these requirements may be more costly or time-consuming than we currently
anticipate.
Each
of
our products in development is novel both in terms of its composition and
function. Thus, we may encounter unexpected safety, efficacy or manufacturing
issues as we seek to obtain marketing approval for products from the FDA, and
there can be no assurance that we will be able to obtain approval from the
FDA
or any foreign governmental agencies for marketing of any of our products.
The
failure to receive, or any significant delay in receiving, FDA approval, or
the
imposition of significant limitations on the indicated uses of our products,
would have a material adverse effect on our business, operating results and
financial condition. The health regulatory authorities of certain countries,
including those of Japan, France and the United Kingdom, have previously
objected, and other countries’ regulatory authorities could potentially object,
to the marketing of any therapy that uses pig liver cells (which our
bioartificial liver systems are designed to utilize) due to safety concerns
that
pig cells may transmit viruses or diseases to humans. If the health regulatory
agencies of other countries impose a ban on the use of therapies that
incorporate pig cells, such as our HepatAssist-2TM
bioartificial liver system, we would be prevented from marketing our products
in
those countries. If we are unable to obtain the approval of the health
regulatory authorities in Japan, France, the United Kingdom or other countries,
the potential market for our products will be reduced.
Because
our products are at an early stage of development and have never been marketed,
we do not know if any of our products will ever be approved for marketing,
and
any such approval will take several years to obtain.
Before
obtaining regulatory approvals for the commercial sale of our products,
significant and potentially very costly preclinical and clinical work will
be
necessary. There can be no assurance that we will be able to successfully
complete all required testing of our SEPET™ or HepatAssist-2™ products. While
the time periods for testing our products and obtaining the FDA’s approval are
dependent upon many future variable and unpredictable events, we estimate that
it could take between two to three years to obtain approval for SEPET™ and
approximately three to four years for HepatAssist-2™. The enrollment of patients
for the clinical study of our SEPETTM
cartridge has been slower than we anticipated. Before we can begin clinical
testing of these products, we will need to amend the active Phase III IND to
resume clinical testing of our HepatAssist-2™ product and complete the current
feasibility clinical trial and file an investigational drug exemption, or IDE,
amendment for SEPET™ with the FDA. Both applications will have to be cleared by
the FDA. The FDA may require significant revisions to our clinical testing
plans
or require us to demonstrate efficacy endpoints that are more time-consuming
or
difficult to achieve than what we currently anticipate. We have not yet
completed preparation of these applications, and there can be no assurance
that
we will have sufficient experimental, clinical and technology validation data
to
justify the submission of said applications. Because of the early stage of
development of each of our products, we do not know if we will be able to
generate additional clinical data that will support the filing of the FDA
applications for these products or the FDA’s approval of any product marketing
approval applications or biologic license approval application that we do
file.
The
cost of conducting clinical studies of HepatAssist-2™ exceeds our current
financial resources. Accordingly, we will not be able to conduct such studies
until we obtain additional funding.
We
are
currently considering requesting FDA approval of an amendment to the Phase
III
clinical study of the HepatAssist-2™ system. Such a request will require that we
supplement and/or amend the existing Phase III clinical protocol that was
approved by the FDA for the original HepatAssist system on which the
HepatAssist-2™ is based. The preparation of a modified or supplemented Phase III
clinical protocol will be expensive and difficult to prepare. Although the
cost
of completing the Phase III study in the manner that we currently contemplate
is
uncertain and could vary significantly, if that Phase III clinical study is
authorized by the FDA, we currently estimate that the cost of conducting that
study would be between $15 million and $20 million in addition to the base
cost
of operations of the Company. We currently do not have sufficient funds to
conduct this study and have not identified any sources for obtaining the
required funds. In addition, no assurance can be given that the FDA will accept
our proposed changes to the previously approved Phase III clinical protocol.
The
clinical tests that we would conduct under any FDA-approved protocol are very
expensive to conduct and will cost much more than our current financial
resources. Accordingly, even if the FDA approves the modified Phase III clinical
protocol that we submit for HepatAssist-2™, we will not be able to conduct any
clinical trials until we raise substantial amounts of additional
financing.
Our
bioartificial liver system utilizes a biological component obtained from pigs
that could prevent or restrict the release and use of those
products.
Use
of
liver cells harvested from pig livers carries a risk of transmitting viruses
harmless to pigs but possibly deadly to humans. For instance, all pig cells
carry genetic material of the porcine endogenous retrovirus, or PERV, but its
ability to infect people is unknown. Repeated testing, including a 1999 study
of
160 xenotransplant (transplantation from animals to humans) patients and the
Phase II/III testing of the HepatAssist system by Circe Biomedical, Inc., has
produced no sign of the transmission of PERV to humans. Still, no one can prove
that PERV or another virus would not infect bioartificial liver-treated patients
and cause potentially serious disease. This may result in the FDA or other
health regulatory agencies not approving our HepatAssist-2TM
bioartificial liver system or subsequently banning any further use of our
product should health concerns arise after the product has been approved. The
health regulatory authorities of certain countries, including those of Japan,
France and the United Kingdom, have previously objected, and other countries’
regulatory authorities could potentially object, to the marketing of any therapy
that uses pig liver cells (which our bioartificial liver systems are designed
to
utilize) due to safety concerns that pig cells may transmit viruses or diseases
to humans. At this time, it is unclear whether we will be able to obtain
clinical and product liability insurance that covers the PERV risk.
In
addition to the potential health risks associated with the use of pig liver
cells, our use of xenotransplantation technologies may be opposed by individuals
or organizations on health, religious or ethical grounds. Certain animal rights
groups and other organizations are known to protest animal research and
development programs or to boycott products resulting from such programs.
Previously, some groups have objected to the use of pig liver cells by other
companies, including Circe Biomedical, Inc., that were developing bioartificial
liver support systems, and it is possible that such groups could object to
our
HepatAssist-2TM
bioartificial liver system. Litigation instituted by any of these organizations,
and negative publicity regarding our use of pig liver cells in a bioartificial
liver device, could have a material adverse effect on our business, operating
results and financial condition.
Because
our products represent new approaches to treatment of liver disease, there
are
many uncertainties regarding the development, the market acceptance and the
commercial potential of our products.
Our
products will represent new therapeutic approaches for disease conditions.
We
may, as a result, encounter delays as compared to other products under
development in reaching agreements with the FDA or other applicable governmental
agencies as to the development plans and data that will be required to obtain
marketing approvals from these agencies. There can be no assurance that these
approaches will gain acceptance among doctors or patients or that governmental
or third party medical reimbursement payers will be willing to provide
reimbursement coverage for our products. Moreover, we do not have the marketing
data resources possessed by the major pharmaceutical companies, and we have
not
independently verified the potential size of the commercial markets for any
of
our products. Since our products will represent new approaches to treating
liver
diseases, it may be difficult, in any event, to accurately estimate the
potential revenues from our products, as there currently are no directly
comparable products being marketed.
Despite
our recent $1.35 million private equity financing and current cash on hand,
we
still need to obtain significant additional capital to complete the development
of our liver assist devices, which additional funding may dilute our existing
stockholders.
Based
on
our current proposed plans and assumptions, we anticipate that our existing
funds will be sufficient to fund our operations and capital requirements for
at
least the 12-month period following the date of this prospectus. However, the
clinical development expenses of our products will be very substantial. Based
on
our current assumptions, we estimate that the clinical cost of developing SEPET™
will be approximately $5 million to $10 million, and the clinical cost of
developing HepatAssist-2™ will be between $15 million and $20 million, in excess
of the cost of basic operations of the Company. These amounts, which could
vary
substantially if our assumptions are not correct, are well in excess of the
amount of cash that we currently have available to us. Accordingly, we will
be
required to (i) obtain additional debt or equity financing in order to fund
the
further development of our products and working capital needs, and/or (ii)
enter
into a strategic alliance with a larger pharmaceutical or biomedical company
to
provide its required funding. The amount of funding needed to complete the
development of one or both of our products will be very substantial and may
be
in excess of our ability to raise capital.
We
have
not identified the sources for the additional financing that we will require,
and we do not have commitments from any third parties to provide this financing.
There can be no assurance that sufficient funding will be available to us at
acceptable terms or at all. If we are unable to obtain sufficient financing
on a
timely basis, the development of our products could be delayed and we could
be
forced to reduce the scope of our pre-clinical and clinical trials or otherwise
limit or terminate our operations altogether. Any equity additional funding
that
we obtain will reduce the percentage ownership held by our existing security
holders.
As
a new small company that will be competing against numerous large, established
companies that have substantially greater financial, technical, manufacturing,
marketing, distribution and other resources than us, we will be at a competitive
disadvantage.
The
pharmaceutical, biopharmaceutical and biotechnology industry is characterized
by
intense competition and rapid and significant technological advancements. Many
companies, research institutions and universities are working in a number of
areas similar to our primary fields of interest to develop new products, some
of
which may be similar and/or competitive to our products. Furthermore, many
companies are engaged in the development of medical devices or products that
are
or will be competitive with our proposed products. Most of the companies with
which we compete have substantially greater financial, technical, manufacturing,
marketing, distribution and other resources than us.
We
will need to outsource and rely on third parties for the clinical development
and manufacture and marketing of our products.
Our
business model calls for the outsourcing of the clinical development,
manufacturing and marketing of our products in order to reduce our capital
and
infrastructure costs as a means of potentially improving the profitability
of
these products for us. We have not yet entered into any strategic alliances
or
other licensing or exclusive contract manufacturing arrangements and there
can
be no assurance that we will be able to enter into satisfactory arrangements
for
these services or the manufacture or marketing of our products. We will be
required to expend substantial amounts to retain and continue to utilize the
services of one or more clinical research management organizations without
any
assurance that the products covered by the clinical trials conducted under
their
management ultimately will generate any revenues for SEPET™ and/or
HepatAssist-2TM.
Consistent with our business model, we will seek to enter into strategic
alliances with other larger companies to market and sell our products. In
addition, we may need to utilize contract manufacturers to manufacture our
products or even our commercial supplies, and we may contract with independent
sales and marketing firms to use their pharmaceutical sales force on a contract
basis.
To
the
extent that we rely on other companies to manage the conduct of our clinical
trials and to manufacture or market our products, we will be dependent on the
timeliness and effectiveness of their efforts. If the clinical research
management organization that we utilize is unable to allocate sufficient
qualified personnel to our studies or if the work performed by them does not
fully satisfy the rigorous requirement of the FDA, we may encounter substantial
delays and increased costs in completing our clinical trials. If the
manufacturers of the raw material and finished product for our clinical trials
are unable to meet our time schedules or cost parameters, the timing of our
clinical trials and development of our products may be adversely affected.
Any
manufacturer that we select may encounter difficulties in scaling-up the
manufacture of new products in commercial quantities, including problems
involving product yields, product stability or shelf life, quality control,
adequacy of control procedures and policies, compliance with FDA regulations
and
the need for further FDA approval of any new manufacturing processes and
facilities. Should our manufacturing or marketing company encounter regulatory
problems with the FDA, FDA approval of our products could be delayed or the
marketing of our products could be suspended or otherwise adversely
affected.
Because
we are currently dependent on Spectrum Laboratories, Inc. as the manufacturer
of
our SEPET™ cartridges, any failure or delay by Spectrum Laboratories to
manufacture the cartridges will negatively affect our future
operations.
We
have
an exclusive manufacturing arrangement with Spectrum Laboratories for our
fiber-within-fiber LIVERAID™ cartridges, which we no longer intend to pursue.
Although we have no agreement with Spectrum Laboratories for the manufacture
of
the SEPET™ cartridges, Spectrum Laboratories has also been providing us with
cartridges for prototypes of SEPET™ and has expressed an interest in
manufacturing the HepatAssist-2™ cartridge. Although Spectrum Laboratories has
agreed to transfer all of the know-how related to these products to any other
manufacturer of our products if Spectrum Laboratories is unable to meet its
contractual obligations to us, we may have difficulty in finding a replacement
manufacturer if we are unable to effectively transfer the Spectrum Laboratories
know-how to another manufacturer. We have no control over Spectrum Laboratories
or its suppliers, and if Spectrum Laboratories is unable to produce
SEPETTM
cartridges on a timely basis, our business may be adversely
affected.
We
currently do not have a manufacturing arrangement for the cartridges used in
the
HepatAssist-2™ system. While we believe there are several potential contract
manufactures who can produce these cartridges, there can be no assurance that
we
will be able to enter into such an arrangement on commercially favorable terms,
or at all.
Because
we are dependent on Medtronic, Inc. for the perfusion platform used in our
HepatAssist-2TM,
any failure or delay by Medtronic to make the perfusion platform commercially
available will negatively affect our future operations.
We
currently expect that a perfusion system known as the PERFORMER will become
the
platform for our HepatAssist-2™ system. The PERFORMER has been equipped with
proprietary software and our tubing in order to enable the machine to work
with
our bioartificial liver products. A limited number of the PERFORMER units have
been manufactured to date. The PERFORMER is being manufactured by RanD, S.r.l.
(Italy) and marketed by Medtronic, Inc. We currently do not have an agreement
to
purchase the PERFORMER from Medtronic or any other source. In the event that
RanD and Medtronic are either unable or unwilling to manufacture the number
of
PERFORMERS needed to ensure that HepatAssist-2 is commercially viable, we would
not have an alternate platform immediately available for use, and the
development and sales of such a system would cease until an alternate platform
is developed or found. We may have difficulty in finding a replacement platform
and may be required to develop a new platform in collaboration with a third
party contract manufacturer. While we believe there are several potential
contract manufacturers who can develop and manufacture perfusion platforms
meeting the HepatAssist-2™ functional and operational characteristics, there can
be no assurance that we will be able to enter into such an arrangement on
commercially favorable terms, or at all. In addition, we may encounter
substantial delays and increased costs in completing our clinical trials if
we
have difficulty in finding a replacement platform or if we are required to
develop a new platform for bioartificial liver use.
We
may not have sufficient legal protection of our proprietary rights, which could
result in the use of our intellectual properties by our
competitors.
Our
ability to compete successfully will depend, in part, on our ability to defend
patents that have issued, obtain new patents, protect trade secrets and operate
without infringing the proprietary rights of others. We currently own seven
U.S.
and three foreign patents on our liver support products, have one patent
application pending, and are the licensee of seven additional liver support
patents. We have relied substantially on the patent legal work that was
performed for our assignors and licensors with respect to all of these patents,
application and licenses, and have not independently verified the validity
or
any other aspects of the patents or patent applications covering our products
with our own patent counsel.
Even
when
we have obtained patent protection for our products, there is no guarantee
that
the coverage of these patents will be sufficiently broad to protect us from
competitors or that we will be able to enforce our patents against potential
infringers. Patent litigation is expensive, and we may not be able to afford
the
costs. Third parties could also assert that our products infringe patents or
other proprietary rights held by them.
We
will
attempt to protect our proprietary information as trade secrets through
nondisclosure agreements with each of our employees, licensing partners,
consultants, agents and other organizations to which we disclose our proprietary
information. There can be no assurance, however, that these agreements will
provide effective protection for our proprietary information in the event of
unauthorized use of disclosure of such information.
The
development of our products is dependent upon Dr. Rozga and certain other
persons, and the loss of one or more of these key persons would materially
and
adversely affect our business and prospects.
We
are
highly dependent on Jacek Rozga, MD, PhD, our Chief Scientific Officer. To
a
lesser extent, we also depend upon the medical and scientific advisory services
that we receive from the members of our Board of Directors, all of whom have
extensive backgrounds in medicine. However, each of these individuals, except
Dr. Rozga, works for us as an unpaid advisor only on a part-time, very limited
basis. We are also dependent upon the voluntary advisory services of Achilles
A.
Demetriou, MD, PhD, FACS, the other co-founder of Arbios and the Chairman of
our
Scientific Advisory Board. In addition, we are dependent on the services of
our
Chief Executive Officer, Walter C. Ogier, to provide investor relations
contacts, establish strategic relationships, and oversee the raising of capital
for the Company. We do not have a long-term employment contract with Dr. Rozga,
Dr. Demetriou or Mr. Ogier, and the loss of the services of any of the foregoing
persons would have a material adverse effect on our business, operations and
on
the development of our products. We do not carry key man life insurance on
any
of these individuals.
As
we
expand the scope of our operations by preparing FDA submissions, conducting
multiple clinical trials, and potentially acquiring related technologies, we
will need to obtain the full-time services of additional senior scientific
and
management personnel. Competition for these personnel is intense, and there
can
be no assurance that we will be able to attract or retain qualified senior
personnel. As we retain full-time senior personnel, our overhead expenses for
salaries and related items will increase substantially from current
levels.
The
market success of our products will be dependent in part upon third-party
reimbursement policies that have not yet been established.
Our
ability to successfully penetrate the market for our products may depend
significantly on the availability of reimbursement for our products from
third-party payers, such as governmental programs, private insurance and private
health plans. We have not yet established reimbursement guidelines with
Medicare, its counterparts in other countries, or any third-party payers. We
cannot predict whether levels of reimbursement for our products, if any, will
be
high enough to allow us to charge a reasonable profit margin. Even with FDA
or
other regulatory approval in foreign countries, third-party payers may deny
reimbursement if the payer determines that our particular new products are
unnecessary, inappropriate or not cost effective. If patients are not entitled
to receive reimbursement similar to reimbursement for competing products, they
may be unwilling to use our products since they will have to pay for the
unreimbursed amounts, which may well be substantial. The reimbursement status
of
newly approved health care products is highly uncertain. If levels of
reimbursement are decreased in the future, the demand for our products could
diminish or our ability to sell our products on a profitable basis could be
adversely affected.
We
may be subject to product liability claims that could have a material negative
effect on our operations and on our financial condition.
The
development, manufacture and sale of medical products expose us to the risk
of
significant damages from product liability claims. We plan to obtain and
maintain product liability insurance for coverage of our clinical trial
activities. However, there can be no assurance that we will be able to secure
such insurance for clinical trials for either of our two current products.
We
intend to obtain coverage for our products when they enter the marketplace
(as
well as requiring the manufacturers of our products to maintain insurance).
We
do not know if it will be available to us at acceptable costs. We may encounter
difficulty in obtaining clinical trial or commercial product liability insurance
for any bioartificial liver device that we develop since this therapy includes
the use of pig liver cells and we are not aware of any therapy using these
cells
that has sought or obtained such insurance. If the cost of insurance is too
high
or insurance is unavailable to us, we will have to self-insure. A successful
claim in excess of product liability coverage could have a material adverse
effect on our business, financial condition and results of operations. The
costs
for many forms of liability insurance have risen substantially during the past
year, and such costs may continue to increase in the future, which could
materially impact our costs for clinical or product liability
insurance.
If
we are not able to implement the requirements of Section 404 of the
Sarbanes-Oxley Act of 2002 in a timely manner or with adequate compliance,
we
may be unable to provide the required financial information in a timely and
reliable manner and may be subject to sanction to regulatory
authorities.
We
cannot
be certain at this time that we will have the expertise and resources to be
able
to comply with all of our reporting obligations and successfully complete the
procedures, certification and attestation requirements of Section 404 of the
Sarbanes-Oxley Act of 202 by the time that we are required to do so. If we
fail
to comply with the requirements of Section 404, or if we or our independent
registered public accounting firm identifies any material weaknesses, the
accuracy and timeliness of the filing of our annual and quarterly reports may
be
negatively affected and could cause investors to lose confidence in our
financial statements, impair our ability to obtain financing or result in
regulatory sanctions. Remediating any material weakness could require additional
management attention and increased compliance costs.
Changes in
stock option accounting rules may adversely affect our reported operating
results, our stock price, and our ability to attract and retain
employees.
In
December 2004, the Financial Accounting Standards Board published new rules
that
will require companies to record all stock-based employee compensation as an
expense. The new rules apply to stock options grants, as well as a wide range
of
other share-based compensation arrangements including restricted share plans,
performance-based awards, share appreciation rights, and employee share purchase
plans. Large public companies have had to apply the new financial accounting
rules to the first interim or annual reporting period that begins after June
15,
2005, while small business issuers such as this company will have to apply
the
new rules in their first reporting period beginning after December 15, 2005.
As
a small company with limited financial resources, we have depended upon
compensating our officers, directors, employees and consultants with such stock
based compensation awards in the past in order to limit our cash expenditures
and to attract and retain officers, directors, employees and consultants.
Accordingly, if we continue to grant stock options or other stock based
compensation awards to our officers, directors, employees, and consultants
after
the new rules apply to us, our future earnings, if any, will be reduced (or
our
future losses will be increased) by the expenses recorded for those grants.
These compensation expenses may be larger than the compensation expense that
we
would be required to record were we able to compensate these persons with cash
in lieu of securities. Since we are a small company, the expenses we may have
to
record as a result of future options grants may be significant and may
materially negatively affect our reported financial results. The adverse effects
that the new accounting rules may have on our future financial statements should
we continue to rely heavily on stock-based compensation may reduce our stock
price and make it more difficult for us to attract new investors. In addition,
reducing our use of stock plans to reward and incentivize our officers,
directors and employees, we could result in a competitive disadvantage to us
in
the employee marketplace.
If
we make any further acquisitions, we will incur a variety of costs and might
never successfully integrate the acquired product or business into
ours.
Following
on our acquisition of HepatAssist®
system
from Circe Biomedical, Inc., we might attempt to acquire products or businesses
that we believe are a strategic complement to our business model. We might
encounter operating difficulties and expenditures relating to integrating
HepatAssist®
or any
other an acquired product or business. These acquisitions might require
significant management attention that would otherwise be available for ongoing
development of our business. In addition, we might never realize the anticipated
benefits of any acquisition. We might also make dilutive issuances of equity
securities, incur debt or experience a decrease in cash available for our
operations, incur contingent liabilities and/or amortization expenses relating
to goodwill and other intangible assets, or incur employee dissatisfaction
in
connection with future acquisitions.
Risks
Related to our Common Stock
Our
stock is thinly traded, so you may be unable to sell at or near ask prices
or at
all if you need to sell your shares to raise money or otherwise desire to
liquidate your shares.
The
shares of our common stock are thinly-traded on the OTC Bulletin Board, meaning
that the number of persons interested in purchasing our common shares at or
near
ask prices at any given time may be relatively small or non-existent. This
situation is attributable to a number of factors, including the fact that we
are
a small company which is relatively unknown to stock analysts, stock brokers,
institutional investors and others in the investment community that generate
or
influence sales volume, and that even if we came to the attention of such
persons, they tend to be risk-averse and would be reluctant to follow an
unproven, early stage company such as ours or purchase or recommend the purchase
of our shares until such time as we became more seasoned and viable. As a
consequence, there may be periods of several days or more when trading activity
in our shares is minimal or non-existent, as compared to a seasoned issuer
which
has a large and steady volume of trading activity that will generally support
continuous sales without an adverse effect on share price. We cannot give you
any assurance that a broader or more active public trading market for our common
shares will develop or be sustained, or that current trading levels will be
sustained. Due to these conditions, we can give you no assurance that you will
be able to sell your shares at or near ask prices or at all if you need money
or
otherwise desire to liquidate your shares.
If
securities or independent industry analysts do not publish research reports
about our business, our stock price and trading volume could
decline.
Small,
relatively unknown companies can achieve visibility in the trading market
through research and reports that industry or securities analysts publish.
However, to our knowledge, no independent analysts cover our company. The lack
of published reports by independent securities analysts could limit the interest
in our stock and negatively affect our stock price. We do not have any control
over research and reports these analysts publish or whether they will be
published at all. If any analyst who does cover us downgrades our stock, our
stock price would likely decline. If any independent analyst ceases coverage
of
our company or fails to regularly publish reports on us, we could lose
visibility in the financial markets, which in turn could cause our stock price
or trading volume to decline.
You
may have difficulty selling our shares because they are deemed “penny
stocks.”
Since
our
common stock is not listed on the Nasdaq Stock Market, if the trading price
of
our common stock is below $5.00 per share, trading in our common stock will
be
subject to the requirements of certain rules promulgated under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), which require additional
disclosure by broker-dealers in connection with any trades involving a stock
defined as a penny stock (generally, any non-Nasdaq equity security that has
a
market price of less than $5.00 per share, subject to certain exceptions).
Such
rules require the delivery, prior to any penny stock transaction, of a
disclosure schedule explaining the penny stock market and the risks associated
therewith and impose various sales practice requirements on broker-dealers
who
sell penny stocks to persons other than established customers and accredited
investors (generally defined as an investor with a net worth in excess of
$1,000,000 or annual income exceeding $200,000 individually or $300,000 together
with a spouse). For these types of transactions, the broker-dealer must make
a
special suitability determination for the purchaser and have received the
purchaser’s written consent to the transaction prior to the sale. The
broker-dealer also must disclose the commissions payable to the broker-dealer,
current bid and offer quotations for the penny stock and, if the broker-dealer
is the sole market-maker, the broker-dealer must disclose this fact and the
broker-dealer’s presumed control over the market. Such information must be
provided to the customer orally or in writing before or with the written
confirmation of trade sent to the customer. Monthly statements must be sent
disclosing recent price information for the penny stock held in the account
and
information on the limited market in penny stocks. The additional burdens
imposed upon broker-dealers by such requirements could discourage broker-dealers
from effecting transactions in our common stock, which could severely limit
the
market liquidity of the common stock and the ability of holders of the common
stock to sell their shares.
Anti-takeover
provisions in our certificate of incorporation could affect the value of our
stock.
Our
certificate of incorporation contains certain provisions that could be an
impediment to a non-negotiated change in control. In particular, without
stockholder approval we can issue up to 5,000,000 shares of preferred stock
with
rights and preferences determined by the board of directors. These provisions
could make a hostile takeover or other non-negotiated change in control
difficult, so that stockholders would not be able to receive a premium for
their
common stock.
Potential
issuance of additional common and preferred stock could dilute existing
stockholders.
We
are
authorized to issue up to 60,000,000 shares of common stock. To the extent
of
such authorization, our board of directors has the ability, without seeking
stockholder approval, to issue additional shares of common stock in the future
for such consideration as the board of directors may consider sufficient. The
issuance of additional common stock in the future will reduce the proportionate
ownership and voting power of the common stock offered hereby. We are also
authorized to issue up to 5,000,000 shares of preferred stock, the rights and
preferences of which may be designated in series by the board of directors.
Such
designation of new series of preferred stock may be made without stockholder
approval, and could create additional securities which would have dividend
and
liquidation preferences over the common stock offered hereby. Preferred
stockholders could adversely affect the rights of holders of common stock
by:
· |
exercising
voting, redemption and conversion rights to the detriment of the
holders
of common stock;
|
· |
receiving
preferences over the holders of common stock regarding or surplus
funds in
the event of our dissolution or
liquidation;
|
· |
delaying,
deferring or preventing a change in control of our company;
and
|
· |
discouraging
bids for our common stock.
|
Additionally,
some of our outstanding warrants to purchase common stock have anti-dilution
protection. This means that if we issue securities for a price less than the
price at which the warrants are exercisable for shares of common stock, the
warrants will become eligible to purchase more shares of common stock at a
lower
price, which will dilute the ownership of our common stockholders.
Substantial
number of shares of common stock may be released onto the market at any time,
and the sales of such additional shares of common stock could cause stock price
to fall.
As
of
April 17, 2006, we had outstanding 17,460,181 shares of common stock. However,
in the past year, the average daily trading volume of our shares has only been
a
few thousand shares, and there have been many days in which no shares were
traded at all. In October 2004 and in February 2005, we registered a total
of
7,207,810 shares of our common stock issuable upon the exercise of outstanding
warrants. Of these shares, 25,000 have been issued upon the exercise of a
warrant and a warrant for 75,000 of the shares has been cancelled without being
registered. The remaining 7,107,810 shares underlying warrants have not yet
been
issued and will not be issued until the warrants are exercised. Since the shares
underlying these warrants have been registered, they can be sold immediately
following the exercise. Accordingly, 7,107,810 additional shares could be
released onto the trading market at any time. Because of the limited trading
volume, the sudden release of 7,107,810 additional freely trading shares onto
the market, or the perception that such shares will come onto the market, could
have an adverse affect on the trading price of the stock. In addition, there
are
currently 5,972,272 shares of unregistered, restricted stock that are currently
eligible for public resale under Rule 144 promulgated under the Securities
Act,
some of which shares also may be offered and sold on the market from time to
time. No prediction can be made as to the effect, if any, that sales of the
7,107,810 registered warrant shares, or the sale of any of the 5,972,272 shares
subject to Rule 144 sales will have on the market prices prevailing from time
to
time. Nevertheless, the possibility that substantial amounts of common stock
may
be sold in the public market may adversely affect prevailing market prices
for
our common stock and could impair our ability to raise capital through the
sale
of our equity securities.
The
market price of our stock may be adversely affected by market
volatility.
The
market price of our common stock is likely to be volatile and could fluctuate
widely in response to many factors, including:
· |
announcements
of the results of clinical trials by us or our
competitors;
|
· |
developments
with respect to patents or proprietary
rights;
|
· |
announcements
of technological innovations by us or our
competitors;
|
· |
announcements
of new products or new contracts by us or our
competitors;
|
· |
actual
or anticipated variations in our operating results due to the level
of
development expenses and other
factors;
|
· |
changes
in financial estimates by securities analysts and whether our earnings
meet or exceed such estimates;
|
· |
conditions
and trends in the pharmaceutical and other
industries;
|
· |
new
accounting standards;
|
· |
general
economic, political and market conditions and other factors, and
the
occurrence of any of the risks described in this
prospectus.
|
FORWARD-LOOKING
STATEMENTS
The
Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for
forward-looking statements. This document contains forward-looking statements,
which reflect the views of our management with respect to future events and
financial performance. These forward-looking statements are subject to a number
of uncertainties and other factors that could cause actual results to differ
materially from such statements. Forward-looking statements are identified
by
words such as “anticipates,” “believes,” “estimates,” “expects,” “plans,”
“projects,” “targets” and similar expressions. Readers are cautioned not to
place undue reliance on these forward-looking statements, which are based on
the
information available to management at this time and which speak only as of
this
date. We undertake no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.
For a discussion of some of the factors that may cause actual results to differ
materially from those suggested by the forward-looking statements, please read
carefully the information under “Risk Factors” beginning on page 4.
The
identification in this document of factors that may affect future performance
and the accuracy of forward-looking statements is meant to be illustrative
and
by no means exhaustive. All forward-looking statements should be evaluated
with
the understanding of their inherent uncertainty. You may rely only on the
information contained in this prospectus.
We
have
not authorized anyone to provide information different from that contained
in
this prospectus. Neither the delivery of this prospectus nor the sale of common
stock means that information contained in this prospectus is correct after
the
date of this prospectus. This prospectus is not an offer to sell or solicitation
of an offer to buy these securities in any circumstances under which the offer
or solicitation is unlawful.
USE
OF PROCEEDS
We
will
not receive any proceeds from the sale or other disposition of the common stock
covered hereby by the selling stockholders pursuant to this prospectus. However,
we may receive the sale price of any common stock we sell to the selling
stockholders upon exercise of the warrants. If all warrants included in this
prospectus are exercised for cash (and not pursuant to the cashless exercise
feature included in the warrants), the total amount of proceeds we would receive
is $920,451. We expect to use the proceeds we receive from the exercise of
warrants, if any, for general working capital purposes. We will pay the expenses
of registration of these shares, including legal and accounting
fees.
MARKET
PRICE OF COMMON STOCK
AND
OTHER SHAREHOLDER MATTERS
Market
Information
Our
common stock has been traded on the OTC Bulletin Board over-the-counter market
since March 18, 2004 under the symbol “ABOS.” From the Reorganization until
March 18, 2004, our common stock was listed on the Pink Sheets over-the-counter
electronic trading system under the symbol “ABOS.” Before to the Reorganization
on October 30, 2003, our common stock was listed on the Pink Sheets under the
symbol “HIAU,” but there was virtually no trading in the common
stock.
Our
common stock will be offered in amounts, at prices, and on terms to be
determined in light of market conditions at the time of sale. The shares may
be
sold directly by the selling stockholders in the open market at prevailing
prices or in individually negotiated transactions, through agents, underwriters,
or dealers. We will not control or determine the price at which the shares
are
sold.
The
following table sets forth the high and low bid information for our common
stock
for each quarter within the last two fiscal years, as reported by Bloomberg
L.P.
The following price information reflects inter-dealer prices, without retail
mark-up, mark-down or commission and may not represent actual
transactions:
Quarter
Ending
|
|
|
High
|
|
Low
|
|
March
31, 2004
|
|
|
$
|
2.60
|
|
$
|
2.25
|
|
June
30, 2004
|
|
|
$
|
4.20
|
|
$
|
2.50
|
|
September
30, 2004
|
|
|
$
|
5.00
|
|
$
|
3.85
|
|
December
31, 2004
|
|
|
$
|
4.25
|
|
$
|
2.45
|
|
March
31, 2005
|
|
|
$
|
3.08
|
|
$
|
1.48
|
|
June
30, 2005
|
|
|
$
|
2.85
|
|
$
|
1.51
|
|
September
30, 2005
|
|
|
$
|
2.10
|
|
$
|
1.60
|
|
December
31, 2005
|
|
|
$
|
1.90
|
|
$
|
1.50
|
|
Our
common stock is also listed on the Frankfurt Stock Exchange in Germany. The
trading symbol of our common stock on the Frankfurt Stock Exchange is
“NNV.”
Holders
As
of
April 17, 2006, there were 126 holders of record of our common
stock.
Dividends
We
have
not paid any dividends on our common stock to date and do not anticipate that
we
will be paying dividends in the foreseeable future. Any payment of cash
dividends on our common stock in the future will be dependent upon the amount
of
funds legally available, our earnings, if any, our financial condition, our
anticipated capital requirements and other factors that the Board of Directors
may think are relevant. However, we currently intend for the foreseeable future
to follow a policy of retaining all of our earnings, if any, to finance the
development and expansion of our business and, therefore, do not expect to
pay
any dividends on our common stock in the foreseeable future.
Equity
Compensation Plan Information
The
following table summarizes as of December 31, 2005, the number of securities
to
be issued upon the exercise of outstanding derivative securities (options,
warrants, and rights); the weighted-average exercise price of the outstanding
derivative securities; and the number of securities remaining available for
future issuance under our equity compensation plans.
Plan
Category
|
|
Number
of
securities
to
be
issued
upon
exercise
of
outstanding
options,
warrants,
and
rights
|
|
Weighted-
average
exercise
price
of
outstanding
options,
warrants
and
rights
|
|
Number
of
securities
remaining
available
for future
issuance
under
equity
compensation
plans
(excluding
securities
reflected
in
column (a))
|
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
Equity
compensation plans approved by security holders(1)
|
|
|
2,100,000
|
|
$
|
1.62
|
|
|
1,900,000
|
|
Equity
compensation plans not approved by security holders
|
|
|
475,000(2
|
)
|
$
|
1.15
|
|
|
-0-
|
|
Total
|
|
|
2,575,000
|
|
$
|
1.54
|
|
|
1,900,000
|
|
(1) These
plans consist of our 2001 Stock Option Plan and 2005 Stock Incentive
Plan.
(2) Represents
warrants to purchase shares of our common stock issued to our
consultants.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
Overview
On
October 30, 2003, we completed a reorganization (the “Reorganization”) in which
Arbios Technologies, Inc., or ATI, our operating company, became our
wholly-owned subsidiary. At the time of the Reorganization, we had virtually
no
assets and virtually no liabilities (prior to the Reorganization we were an
e-commerce based company engaged in the business of acquiring and marketing
historical documents). Shortly after the Reorganization, we changed our name
to
“Arbios Systems, Inc.” In the Reorganization, we also replaced our officers and
directors with those of ATI. Following the Reorganization, we ceased our
e-commerce business, closed our former offices, and moved our offices to Los
Angeles, California. We currently do not plan to conduct any business other
than
the business of developing liver assist devices that Arbios Systems, Inc. has
conducted since its organization. In July 2005, we merged ATI into the parent
company, Arbios Systems, Inc.
Although
we acquired ATI in the Reorganization, for accounting purposes, the
Reorganization was accounted for as a reverse merger since the stockholders
of
ATI acquired a majority of the issued and outstanding shares of our common
stock, and the directors and executive officers of ATI became our directors
and
executive officers. Accordingly, the financial statements contained in this
prospectus, and the description of our results of operations and financial
condition, reflect (i) the operations of ATI alone prior to the Reorganization,
and (ii) the combined results of this company and ATI since the Reorganization.
No goodwill was recorded as a result of the Reorganization.
Since
the
formation of ATI in 2000, our efforts have been principally devoted to research
and development activities, raising capital, and recruiting additional
scientific and management personnel and advisors. To date, we have not marketed
or sold any product and have not generated any revenues from commercial
activities, and we do not expect to generate any revenues from commercial
activities during the next 12 months. Substantially all of the revenues that
we
have recognized to date have been Small Business Innovation Research grants
(in
an aggregate amount of $321,000) that we received from the United States Small
Business Administration.
Our
current plan of operations for the next 12 months primarily involves research
and development activities, including clinical trials for SEPET™, and the
preparation and submission of applications to the FDA. We submitted an
investigational device exemption, or IDE, application for SEPET™ in March 2005
and commenced clinical studies for SEPET™ in the third quarter of 2005. We also
intend to reactivate work on the HepatAssist bioartificial liver system by
modifying the FDA-reviewed Phase III IND protocol. Because the anticipated
cost
of conducting clinical studies for the HepatAssist-2™ system exceeds our current
financial resources, we will not, however, be able to commence clinical studies
for the HepatAssist-2™ system until we raise additional capital. The actual
amounts we may expend on research and development and related activities during
the next 12 months may vary significantly depending on numerous factors,
including the results of our clinical studies and the timing and cost of
regulatory submissions. However, based on our current estimates, we believe
that
we have sufficient financial resources to conduct our planned operations for
at
least the next 12-month period following the date of this
prospectus.
In
April
2004 we purchased certain assets of Circe Biomedical including a portfolio
of
patents, rights to a bioartificial liver (HepatAssist), a Phase III IND,
selected equipment, clinical and marketing data, and over 400 standard operating
procedures and clinical protocols that have previously been reviewed by the
FDA.
The purchase price paid for these assets was $450,000, which amount has now
been
fully paid.
Critical
Accounting Policies
Management’s
discussion and analysis of our financial condition and results of operations
are
based on our consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States.
The preparation of these financial statements requires management to make
estimates and judgments that affect the reported amounts of assets, liabilities,
revenues and expenses, and related disclosure of contingent assets and
liabilities. On an ongoing basis, management evaluates its estimates, including
those related to revenue recognition, impairment of long-lived assets, including
finite lived intangible assets, accrued liabilities and certain expenses. We
base our estimates on historical experience and on various other assumptions
that we believe to be reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. Actual results
may
differ materially from these estimates under different assumptions or
conditions.
Our
significant accounting policies are summarized in Note 1 to our audited
financial statements for the year ended December 31, 2005. We believe the
following critical accounting policies affect our more significant judgments
and
estimates used in the preparation of our consolidated financial
statements:
Development
Stage Enterprise
We
are a
development stage enterprise as defined by the Financial Accounting Standards
Board's ("FASB") Statement of Financial Accounting Standards ("SFAS") No. 7,
"Accounting and Reporting by Development Stage Enterprises." We are devoting
substantially all of our present efforts to research and development. All losses
accumulated since inception have been considered as part of our development
stage activities.
Short
Term Investments
Short-term
investments generally mature between three and twelve months. Short term
investments consist of U.S. government agency notes purchased at a discount
with
interest accruing to the notes full value at maturity. All of our short-term
investments are classified as available-for-sale and are carried at fair market
value which approximates cost plus accrued interest.
Patents
In
accordance with FASB No. 2, the costs of intangibles that are purchased from
others for use in research and development activities and that have alternative
future uses are capitalized and amortized. We capitalize certain patent rights
that are believed to have future economic benefit. The licensed capitalized
patent costs were recorded based on the estimated value of the equity security
issued by us to the licensor. The value ascribed to the equity security took
into account, among other factors, our stage of development and the value of
other companies developing extracorporeal bioartificial liver assist devices.
These patent rights are amortized using the straight-line method over the
remaining life of the patent. Certain patent rights received in conjunction
with
purchased research and development costs have been expensed. Legal costs
incurred in obtaining, recording and defending patents are expensed as
incurred.
Stock-Based
Compensation
SFAS
No.
123, "Accounting for Stock-Based Compensation," as in effect prior to December
2004, established and encouraged the use of the fair value based method of
accounting for stock-based compensation arrangements under which compensation
cost is determined using the fair value of stock-based compensation determined
as of the date of grant and is recognized over the periods in which the related
services are rendered. The statement also permitted companies to elect to
continue using the current intrinsic value accounting method specified in
Accounting Principles Board ("APB") Opinion No. 25, "Accounting for Stock Issued
to Employees," to account for stock-based compensation. To date, we have used
the intrinsic value based method and have disclosed the pro forma effect of
using the fair value based method to account for our stock-based compensation.
For non-employee stock based compensation, we recognized an expense in
accordance with SFAS No. 123 and value the equity securities based on the fair
value of the security on the date of grant. The fair value of expensed options
is estimated using the Black-Scholes option-pricing model. In December 2004,
the
FASB issued SFAS No. 123 (revised 2004), “Share-Based Payment”. Statement 123(R)
requires that the compensation cost relating to a wide range of share-based
payment transactions (including stock options) be recognized in financial
statements. That cost will be measured based on the fair value of the equity
instruments issued. Statement 123(R) replaces FASB Statement No. 123 and
supersedes APB Opinion No. 25. As a small business issuer, we will be required
to apply Statement 123(R) to reporting periods that begin on January 1,
2006.
New
Accounting Pronouncements
In
December 2004, the FASB issued SFAS 123(R) (revised 2004), “Share-Based
Payment.” SFAS 123(R) will provide investors and other users of financial
statements with more complete and neutral financial information by requiring
that the compensation cost relating to share-based payment transactions be
recognized in financial statements. That cost will be measured based on the
fair
value of the equity or liability instruments issued. SFAS 123(R) covers a wide
range of share-based compensation arrangements including share options,
restricted share plans, performance-based awards, share appreciation rights,
and
employee share purchase plans. SFAS 123(R) replaces SFAS No. 123, “Accounting
for Stock-Based Compensation”, and supersedes APB Opinion No. 25, Accounting for
Stock Issued to Employees. SFAS 123, as originally issued in 1995, established
as preferable a fair-value-based method of accounting for share-based payment
transactions with employees. However, SFAS 123(R) permitted entities the option
of continuing to apply the guidance in APB Opinion 25, as long as the footnotes
to financial statements disclosed what net income would have been had the
preferable fair-value-based method been used. Our Company will be implementing
SFAS 123(R) as of January 1, 2006, and the projected additional expense is
approximately $400,000 based upon options granted as of December 31,
2005.
In
March
2005, the Securities and Exchange Commission (SEC) issued Staff Accounting
Bulletin No. 107 (SAB 107) regarding the Staff's interpretation of SFAS 123(R).
This interpretation expresses the views of the Staff regarding the interaction
between SFAS 123(R) and certain rules and regulations and provides the Staff's
views regarding the valuation of share-based payment arrangements for public
companies. In particular, this SAB provides guidance related to share-based
payment transactions with no employees, the transition from nonpublic to public
entity status, valuation methods, the accounting for certain redeemable
financial instruments issued under share-based payment arrangements, the
classification of compensation expense, non-GAAP financial measures, first-time
adoption of SFAS 123(R) in an interim period, capitalization of compensation
cost related to share-based payment arrangements, the accounting for income
tax
effects of share-based payment arrangements upon adoption of SFAS 123(R), the
modification of employee share options prior to adoption of Statement 123(R)
and
disclosures in Management's Discussion and Analysis subsequent to adoption
of
SFAS 123(R). Our company will adopt SAB 107 in connection with its adoption
of
SFAS 123(R).
In
May
2005, the FASB issued SFAS 154, “Accounting Changes and Error Corrections - a
replacement of APB Opinion No. 20 and FASB Statement No. 3.” SFAS 154 replaces
APB Opinion No. 20, “Accounting Changes,” and FASB Statement No. 3, “Reporting
Accounting Changes in Interim Financial Statements” and changes the requirements
for the accounting for and reporting of a change in accounting principles.
This
statement applies to all voluntary changes in accounting principle. It also
applies to changes required by an accounting pronouncement in the unusual
instance that the pronouncement does not include specific transition provisions.
When a pronouncement includes specific transition provisions, those provisions
should be followed. SFAS No. 154 is effective for accounting changes and
corrections of errors made in fiscal years beginning after December 31,
2005.
In
February of 2006 the Financial Accounting Standards Board issued Statement
No.
155, "Accounting for Certain Hybrid Financial Instruments: an amendment of
FASB
Statements Numbers 133 and 140". Management is currently evaluating the effect,
if any, that such pronouncement will have on accounting for our company's equity
instruments which were issued with detachable warrants.
Results
of Operations
Comparison
of Fiscal Year ended December 31, 2005 to Fiscal Year ended December 31,
2004.
Since
we
are still developing our products and do not have any products available for
sale, we have not yet generated any revenues from sales. Revenues for fiscal
year 2004 of $72,030 represent revenues recognized from government research
grants that we have received.
General
and administrative expenses of $2,394,546 and $1,988,763 were incurred for
the
years ended December 31, 2005 and 2004, respectively. For the year ended
December 31, 2005, the expenses include $745,000 in fees incurred to outside
consultants, professionals and board member fees, $509,000 in payroll and
payroll related costs, $477,000 in non-cash option and warrant charges for
grants awarded to consultants, $187,000 in investor relation costs and other
administrative expenses. For the year ended December 31, 2004, the expenses
include $945,000 in non-cash option and warrant charges for grants awarded
to
consultants, $587,000 in fees incurred to outside consultants and professionals,
and $179,000 in salaries and other administrative expenses. Professional fees
increased in 2005 due to consulting services for marketing, recruiting fees,
and
board of directors fees. The reduction in non-cash option and warrant charges
reflect the lower stock price in 2005 and fewer option and warrant grants in
2005. The 2005 increase in payroll and payroll related expenses reflects the
hiring of an interim and later a permanent Chief Executive Officer in 2005
and
employee bonuses.
Research
and development expenses of $1,554,509 and $1,426,379 were incurred for the
years ended December 31, 2005 and 2004, respectively. Research and development
expenses for 2005 consist primarily of $414,000 in payroll and payroll related
expenses, $362,000 in SEPETTM
development, manufacturing and clinical costs, $226,000 in consultant costs
related to manufacturing, regulatory and product management, $141,000 in
employee costs from Cedars-Sinai and $108,000 in HepatAssist2™ facility costs.
Research and development expenses for the 2004 consist primarily of $450,000
of
purchased research and development from Circe Biomedical, Inc., $282,000
incurred for various research and development consultants for manufacturing,
regulatory and product management, $281,000 in employee costs from Cedars-Sinai,
$151,000 in SEPETTM
and
HepatAssist2™ development costs and $101,000 non cash option grant charges for
options awarded to scientific consultants. Research and development costs
increased by $128,130 from 2004 to 2005 and reflect increased expenditures
for
both the SEPETTM
and
HepatAssist2™ programs and increased payroll costs as we increased staff which
replaced employee costs from Cedars-Sinai and certain consulting costs and
the
write off of certain patents which have no future commercial use or economic
benefit to us.
Interest
income of $125,286 and $16,132 was earned for the years ended December 31,
2005
and 2004 respectively. The increase in interest income of $109,154 results
from
the increase in short term interest rates and higher cash balances maintained
in
2005. In January 2005, we raised gross proceeds of $6,611,905 in the private
placement of our securities which resulted in the higher cash balances in 2005.
Our net loss increased to $3,823,903 in 2005 from $3,327,827 in 2004. The
increase in net loss is attributed to an increase in operating expenses incurred
in the fiscal 2005 periods as compared to the same periods in 2004, without
an
increase in revenues.
Liquidity
and Capital Resources
As
of
December 31, 2005, we had cash of $2,379,738 and short term investments of
$1,996,000. We do not have any bank credit lines. To date, we have funded our
operations from the sale of debt and equity securities and from government
research grants.
On
January 11, 2005, we completed a $6,611,905 private equity financing to a group
of institutional investors and accredited investors. In the offering, we sold
2,991,812 shares of our common stock at a price of $2.21 per share to the
investors and issued to them warrants to purchase an additional 1,495,906 shares
of our common stock at an exercise price of $2.90 per share. The warrants are
exercisable for five years and can be redeemed by us after January 11, 2007
if
the average trading price of our common stock for 20 consecutive trading days
is
equal to or greater than $5.80 and the average trading volume of the common
stock is at least 100,000 shares during those 20 days. We also issued warrants
to purchase 114,404 shares of common stock to our placement agent in the
offering.
On
March
6, 2006, we completed a $1,350,000 private equity financing to a group of
institutional investors and accredited investors. In the offering, we sold
1,227,272 shares of our common stock at a price of $1.10 per share to the
investors and issued to them warrants to purchase an additional 613,634 shares
of our common stock at an exercise price of $1.50 per share. The warrants are
exercisable for a period of five years.
Based
on
our current plan of operations and the private placement we completed on March
6, 2006, we believe that our current cash balances will be sufficient to fund
our foreseeable expenses for at least the next 12 months.
We
do not
currently anticipate that we will derive any revenues from either product sales
or from governmental research grants during the current fiscal year. Although
we
are planning to submit an application for an additional SBIR research grant
during 2006, no assurance can be given that the grant application will be
approved. Even if the grant is approved, it is unlikely that we would receive
any grant funds during the current fiscal year.
The
cost
of completing the development of our products and of obtaining all required
regulatory approvals to market our products is substantially greater than the
amount of funds we currently have available and substantially greater than
the
amount we could possibly receive under any governmental grant program. As a
result, we will have to obtain significant additional funds during the next
12-15 months. We currently expect to attempt to obtain additional financing
through the sale of additional equity and possibly through strategic alliances
with larger pharmaceutical or biomedical companies. We cannot be sure that
we
will be able to obtain additional funding from either of these sources, or
that
the terms under which we obtain such funding will be beneficial to this
company.
A
summary
of our contractual cash obligations at December 31, 2005 is as
follows:
|
|
|
|
|
|
|
|
2008
and
|
|
Contractual
Obligations
|
|
Total
|
|
2006
|
|
2007
|
|
thereafter
|
|
Long-Term
Office Leases
|
|
$
|
395,000
|
|
$
|
286,000
|
|
$
|
109,000
|
|
$
|
-0-
|
|
We
do not
believe that inflation has had a material impact on our business or
operations.
We
are
not a party to any off-balance sheet arrangements, and we do not engage in
trading activities involving non-exchange traded contracts. In addition, we
have
no financial guarantees, debt or lease agreements or other arrangements that
could trigger a requirement for an early payment or that could change the value
of our assets.
BUSINESS
Products
Overview
We
currently have two products under development; a novel extracorporeal blood
purification therapy called the SEPET™ Liver Assist Device and an
extracorporeal, bioartificial liver therapy referred to as the HepatAssist-2™
Bioartificial Liver System that incorporates pig liver cells, or porcine
hepatocytes.
SEPET™
is
a single-use cartridge that contains specially designed microporous tubes called
hollow fibers. When a patient’s blood is pumped through these hollow fibers,
substances normally metabolized by the liver and accumulated in the blood during
liver failure move across the porous wall and are discarded. As a result of
this
blood purification, or detoxification, process, we believe that the levels
of
pathological blood components will move toward normal ranges, leading to
amelioration of liver failure and stabilization or improved function of a
patient’s liver. SEPET™ was designed and qualified for use with the PRISMA
hemodialysis system (manufactured by Gambro, Inc.) and for use with other
commercially available kidney dialysis units and/or plasma apheresis systems
that utilize hollow-fiber cartridges.
In
April
2004, we acquired from Circe Biomedical, Inc., an unaffiliated biomedical
company, the rights to a bioartificial liver, known as the HepatAssist® system.
Certain technologies included in the HepatAssist® bioartificial liver were
designed and tested in pre-clinical and early clinical studies by Drs. A. A.
Demetriou and J. Rozga, who later founded Arbios Systems, Inc. Our HepatAssist-2
Bioartificial Liver System utilizes a single-use cartridge that contains pig
liver cells plus columns that contain certain chemical particles referred to
as
sorbents. When a patient’s blood is pumped through the bioartificial liver
cartridge, substances normally metabolized by the liver and accumulated in
the
blood during liver failure move across the porous tubes into two plasma
compartments; one compartment is filled with pig liver cells and the other
compartment incorporates columns that contain sorbents. The exposure of the
viable pig liver cells to patient plasma causes toxic substances contained
in
the plasma to be metabolized, thereby reducing their level. In addition, the
sorbents lower the level of pathological blood components, such as ammonia.
At
the same time, substances produced by pig liver cells move across the porous
wall back into the blood compartment. As a result of these two processes
(provision of whole liver functions by the pig liver cells and removal of toxins
by the sorbents) we believe the levels of pathological and normal blood
components will move toward normal ranges. Our belief is supported by the
results of tests performed during clinical trials using the HepatAssist®
system.
Our
HepatAssist-2™ Bioartificial Liver System is similar to the earlier HepatAssist®
system, and we have subsequently enhanced it by employing a larger quantity
of
pig cells. We do not anticipate that HepatAssist-2™ will use the proprietary
perfusion platform, which is a machine through which the patient’s blood is
circulated, that was originally designed and developed for the HepatAssist®
system. Instead, we are testing a perfusion platform known as the PERFORMER
for
use as the platform to provide bioartificial liver therapy. The PERFORMER is
a
multi-function integrated system capable of supporting extracorporeal
blood/plasma/fluid circulation therapies that is manufactured by RanD S.r.l.
(Italy) and distributed world-wide by Medtronic, Inc. The PERFORMER has been
equipped with proprietary software and a tubing set for use with our
HepatAssist-2™ Bioartificial Liver System.
Both
SEPET™ and HepatAssist-2™ rely on single-use cartridges that are placed on a
blood perfusion apparatus that is attached to the patient's blood circulation
system. Following treatments with any of our products, the disposable cartridges
are discarded, and new cartridges are used for the next therapy.
Background
of our Company
Arbios
Technologies, Inc., our former operating subsidiary, was formed in August of
2000 by Drs. A. A. Demetriou and J. Rozga, two leaders in the field of
artificial liver therapy, to develop extracorporeal therapies for the treatment
of liver failure. As former employees of Cedars-Sinai Medical Center, Drs.
Demetriou and Rozga previously were involved in the development of a first
generation bioartificial liver known as HepatAssist® that was licensed by
Cedars-Sinai Medical Center in 1994 to W.R. Grace & Co. and then
subsequently transferred to Circe Biomedical, Inc. The prior owners of this
technology spent millions of dollars on the research and development of the
original HepatAssist® system, the perfusion platform and on the related
technologies and operating procedures necessary to bring the product to market.
The original HepatAssist® system was tested in Phase II/III clinical trials
approved by the FDA in patients with fulminant and subfulminant liver failure
and primary non-function following liver transplantation. These trials of the
original HepatAssist® system were the first large (171 patients) prospective,
randomized, controlled multi-center trial demonstrating a survival advantage
for
an extracorporeal liver assist system utilizing pig liver cells. Although
treated fulminant/subfulminant hepatic failure patients with viral and
drug-induced liver injury retrospectively demonstrated improved survival
compared to controls when adjusted for the effect of confounding factors (such
as liver transplantation), the prospective primary clinical end point in the
overall study population (survival at 30 days post-transplantation) was not
achieved. Accordingly, the HepatAssist® system was not approved for marketing,
and the FDA requested that a new Phase III clinical study be performed. A new
Phase III protocol was prepared and reviewed by the FDA. However in 2003, before
these new studies could be undertaken, Circe Biomedical ceased its operations.
In April 2004, we purchased the remaining assets of Circe Biomedical that
related to its bioartificial liver operations, including rights to the original
HepatAssist® system, the new Phase III protocol that had been reviewed by the
FDA, and over 400 manufacturing and quality control and quality assurance
standard operation protocols previously reviewed by FDA. In July 2005, we merged
Arbios Technologies, Inc. into the parent company, Arbios Systems,
Inc.
To
date,
we have funded our operations from the gross proceeds of funds we raised from
the sale of over $13,000,000 of our equity securities and $321,000 of Small
Business Innovation Research, or SBIR, grants that have been awarded by the
United States Small Business Administration. We intend to apply for additional
SBIR grants to fund a portion of our research expenditures. However, whether
or
not we receive additional SBIR grants, we will have to raise substantial
additional proceeds to fund our future clinical development expenses and our
on-going working capital needs.
Our
research offices and laboratories are located at Cedars-Sinai Medical Center,
Los Angeles, California. Under our lease agreement and other arrangements with
Cedars-Sinai, we have access to all of the key development resources of that
leading medical center, including animal facilities, surgical core facilities
and clinical laboratories. Cedars-Sinai Medical Center is one of the clinical
testing sites for our SEPETTM
clinical
testing program. We also lease administrative office space in Los Angeles,
California and Waltham, Massachusetts, as well as an animal breeding and cell
manufacturing facility in Woodstock, Connecticut which will be used to harvest
porcine livers for use in our HepatAssist-2TM
product.
We
have
also entered into various agreements with Spectrum Laboratories, Inc., including
research and development agreements and manufacturing agreements. Spectrum
Laboratories is a company that specializes in the development and manufacture
of
innovative molecular separation products for the research community and is
a
supplier of dialysis and ultrafiltration membranes used for biomedical research,
molecular biology and clinical diagnostics throughout the world.
Strategy
We
believe that the clinical testing and regulatory approval periods for the SEPET™
Liver Assist Device will be shorter than our HepatAssist-2TM
Bioartificial Liver System because SEPET™ may be evaluated as a medical device
that does not contain biological components such as the pig cells that are
an
integral part of our HepatAssist-2TM
product.
Accordingly, because
of the shorter regulatory period and the ability of SEPET™ to operate through
the use of a standard, currently available kidney dialysis unit, we expect
that
the development of SEPET™ will be completed before the development of
HepatAssist-2™ is completed.
We
have
already performed in
vitro
and
in
vivo
testing
of the SEPET™ prototype device and commenced clinical testing of SEPET™ during
2005. We anticipate that we will be able to file an application requesting
market approval of SEPET™ as early as late 2007. We are currently evaluating the
possibility of conducting clinical studies of the HepatAssist-2™ system under a
modified version of the FDA-reviewed Phase III IND protocol that we acquired
in
March 2004 from Circe Biomedical. Since we are still currently developing our
clinical and regulatory strategies for the HepatAssist-2TM
Bioartificial Liver System, we cannot estimate when an application requesting
marketing approval of that system will be filed.
The
April
2004 acquisition of the assets of Circe Biomedical has provided us with new
potential opportunities for the development of a bioartificial liver. The Circe
Biomedical bioartificial liver device that we acquired consisted of the
following four distinct components that we believe may be useful to the
development of our bioartificial liver products:
|
(1)
|
FDA-approved
standard operating procedures.
These are standard operating procedures for production of porcine
cells
including harvesting, freezing, storing, shipping and processing
by the
end user (thawing, washing) of the cells. These procedures and protocols
have been reviewed by the FDA.
|
|
(2)
|
The
cartridge used in the Phase III trial of HepatAssistTM.
We intend to use the existing, FDA-approved cartridge, and intend
to seek
the FDA’s approval to increase the number of pig cells that the cartridge
could contain, which increase we believe will improve the functionality
of
the system.
|
|
(3)
|
An
FDA reviewed Phase III protocol acquired from Circe
Biomedical.
We may modify this protocol and submit the modified protocol to the
FDA
for approval.
|
|
(4)
|
The
HepatAssistTM
perfusion platform.
The HepatAssist perfusion platform is Circe Biomedical’s specially
designed machine that pumped the patient’s plasma through the HepatAssist
cartridge. This machine was used in the Phase II/III trial of
HepatAssist.
|
Rather
than using Circe Biomedical’s specially designed machine, we intend to use the
PERFORMER, a commercially available machine that is distributed by Medtronic,
Inc. We are currently testing units of The PERFORMER that have been equipped
with proprietary software and our tubing to enable the machine to work with
our
bioartificial liver products. We believe that the PERFORMER may become the
platform for our HepatAssist-2™ Bioartificial Liver System.
We
are
currently in the process of designing further clinical trials to demonstrate
the
safety and tolerability of SEPET™ in treating patients with acute exacerbation
of chronic liver failure. In April 2005 we received permission from the FDA
to
commence a 15-patient clinical feasibility study for SEPET™. The FDA has since
given permission to expand the trial to a total of up to four clinical sites
and
up to 20 patients. Based on our current assumptions, we estimate that the
clinical cost of developing SEPET™ will be approximately $5 million to $10
million and the clinical cost of developing HepatAssist-2™ will be between $15
million and $20 million. These amounts, which could vary substantially if our
assumptions are not correct, are well in excess of the amount of cash that
we
currently have available to us. See “Management’s Discussion and Analysis or
Plan of Operation - Factors that May Affect Future Results and Market Price
of
Our Stock.”
Liver
Function Background
The
liver
controls, or affects, almost every aspect of metabolism and most physiologic
regulatory processes, including protein synthesis, sugar and fat metabolism,
blood clotting, the immune system, detoxification of alcohol, chemical toxins,
and drugs, and waste removal. Loss of liver function is a devastating and life
threatening condition. Liver failure affects all age groups and may be due
to
many causes, including viral infection, hepatitis, ingestion of common
medications, alcohol, and surgical liver removal for trauma and
cancer.
Currently,
there is no direct treatment for liver failure, except a successful liver
transplant. There is, however, a current scarcity of donor livers, and
approximately two thousand patients on the waiting list for donor livers die
annually before receiving liver transplants. Our management believes that
treatments with currently available technologies such as blood detoxification
methods are short-term measures, and none of them has achieved wide clinical
use
or ability to arrest or reverse liver failure and improve survival. As a
consequence, liver failure patients must still either undergo liver
transplantation or endure the probability of prolonged hospitalization with
a
low probability of survival. In addition, many patients do not qualify for
transplantation or live in regions of the world where transplantation is not
readily available. Still others do not recover after transplantation because
of
irreversible brain damage or other organ damage caused by liver failure.
Although the liver has a remarkable capacity for regeneration, the repair
process after massive liver damage is markedly impaired by the continued
presence of toxins, inflammatory cytokines and other inhibitors of organ
regeneration still present in the blood of patients.
In
liver
failure patients, there is a need for an effective blood purification therapy
that will clear the blood of toxins, mediators of inflammation and inhibitors
of
hepatic growth. SEPET™ is a novel form of such therapy developed by us in which
the plasma fraction containing substances that are toxic to the brain, the
liver
and other internal organs and tissues are removed from patient blood and
replaced with normal human plasma. We have demonstrated an extension of survival
in large animal model testing of SEPET™, which results have led to the
initiation of a clinical feasibility trial in human patients.
There
is
a further need to develop artificial means of liver replacement with the aim
of
either supporting patients with borderline functional liver cell mass until
their liver regenerates or until a donor liver becomes available for
transplantation. Such an “artificial liver” should also support patients during
recovery after transplantation with marginal livers and after extended liver
resections for trauma or cancer. To achieve these effects, effective liver
support systems should be able to lower blood levels of substances toxic to
the
brain and liver and to provide whole liver functions, which are impaired or
lost.
The
founders of this company as well as investigators not associated with this
company have demonstrated in
vitro
and in
animal models of liver failure that cell-based bioartificial livers using viable
isolated liver cells, or hepatocytes, can provide whole liver functions.
However, only a few bioartificial livers have been tested in humans and it
remains to be seen whether systems utilizing hepatocytes as the only means
of
liver support are effective. We believe that in order to provide the maximum
support for the failing liver, porcine hepatocyte therapy should be combined
with blood purification or detoxification.
Our
bioartificial liver system, HepatAssist-2™, was designed to become an advanced
effective application of the basic bioartificial liver concept. In the
bioartificial liver system, liver cell therapy in the form of porcine
hepatocytes, is combined with blood detoxification, in the form of sorbent
based
plasma therapy. Depending on the cause of liver disease, severity of illness
and
deficiency of specific liver functions, the
bioartificial liver mode of therapy can be provided individually, simultaneously
or sequentially. Because of these features, we believe our bioartificial liver
technology is well suited to treat patients with liver failure of all causes
and
severity, including those requiring maximum liver support. While the
HepatAssist-2TM’s
predecessor HepatAssist Phase II/III clinical trial demonstrated an increase
in
patient survival in patients with viral and drug-induced fulminant/subfulminant
hepatic failure, a new Phase III clinical trial will be needed before our
HepatAssist-2™ system, which is an enhanced version of the original HepatAssist
system, can be used by human patients. Pre-clinical data for our
HepatAssist-2TM
Bioartificial Liver System indicates that this system can improve heart rate
and
blood pressure and provide clearance of ammonia and indocyanine green (ICG),
which is a liver function test.
The
Products We Are Developing
We
currently are developing novel treatments for acute and chronic liver failure.
We believe that our SEPET™ Liver Assist Device and our HepatAssist-2TM
Bioartificial Liver System may:
· |
help
keep liver failure patients alive and neurologically intact before,
during
and immediately after
transplantation;
|
· |
allow
other patients to recover liver functionality and to survive without
a
transplant (a “bridge” to liver
regeneration);
|
· |
support
patients during periods of functional recovery and regeneration after
extensive removal due to liver trauma and/or
cancer;
|
· |
accelerate
recovery from acute exacerbation of chronic liver
disease;
|
· |
shorten
length of stay in intensive care
units;
|
· |
reduce
the cost of care; and
|
· |
reduce
intractable itching associated with severe
jaundice.
|
We
believe that our SEPET™ Liver Assist Device and HepatAssist-2 Bioartificial
Liver System can achieve these effects because they can lower blood levels
of
substances that are toxic to both the brain and liver. However, final proof
of
clinical benefit in patients is lacking at this time, and the clinical utility
of these products still needs to be demonstrated in patients with acute liver
failure.
We
own
certain technologies and rights related to our products, and have licensed
certain other technologies. See “- Patents and Proprietary Rights” below for a
description of the rights that we own and have licensed.
SEPET™
We
are
developing the SEPET™ Liver Assist Device as a blood purification measure to
provide temporary liver support during acute liver failure and acute
exacerbation of chronic liver disease. SEPET™ therapy will be provided through
the sale of our single-use, disposable cartridge that contains a bundle of
hollow fibers made of bio- and hemo-compatible material capable of sieving
substances with molecular weight of up to 100 kilodaltons, or kDa. The
importance of using fibers with this sieving characteristic, which is larger
than for conventional renal dialysis cartridges, is that most hepatic failure
toxins as well as mediators of inflammation and inhibitors of hepatic
regeneration have a molecular weight that is less than 100 kDa, while "good"
blood components, for the most part, have molecular weight greater than 100
kDa.
At present, Spectrum Laboratories is the manufacturer of these disposable
cartridges. See “— Manufacturing” below. The SEPET™ system is designed for use
with any commercially available kidney dialysis unit or other similar machines
that utilize hollow-fiber cartridges. Accordingly, no specialized apparatus
needs to be developed or manufactured for SEPET™. Accessory components for the
SEPET™ system such as disposable tubings and connectors will mostly consist of
standard components that are currently used in renal dialysis and provided
by
manufacturers of those systems. We expect that any new accessory components
that
may be required will be manufactured for us by third-party vendors.
During
SEPETTM
therapy,
an ultrafiltrate containing toxins, inhibitors of hepatic growth and mediators
of inflammation with molecular weight of 100 kDa or less will be removed from
the patient’s blood stream by exiting from the side port of the cartridge, while
at the same time, intravenous electrolyte solutions, albumin solution, fresh
frozen plasma, or a combination thereof will be administered to the patient.
We
believe that as a result of these two processes, the levels of pathological
and
normal blood components present in the patient’s circulation will move toward
normal ranges, thereby facilitating recovery from liver failure. Based on
published medical literature, rapid and efficient blood detoxification is
expected to protect the liver, brain and other organs against further injury,
accelerate healing of the native liver and improve its residual
functions.
HepatAssist2™
Bioartificial Liver System
Our
current bioartificial liver system under development is the
HepatAssist-2TM
Bioartificial
Liver System. We have designed our HepatAssist-2™ Bioartificial Liver System to
provide temporary liver support during acute liver failure and acute
exacerbation of chronic liver disease. The HepatAssist-2™ Bioartificial Liver
System incorporates several proprietary components and technologies into an
integrated liver assist system, including a hollow fiber cartridge with porcine
hepatocytes and a plasma re-circulation circuit that incorporates a cell
cartridge and sorbents. The HepatAssist-2TM
Bioartificial Liver System is designed to (i) provide liver cell functions
by
utilizing viable pig liver cells that are housed in specially designed
cartridges and (ii) detoxify blood. Since it has been scientifically established
that pig liver cells perform liver functions when maintained in specially
designed cartridges outside of the human body, our bioartificial liver cartridge
is designed to bring human plasma into contact with viable pig liver cells
in a
manner similar to that observed in the normal human liver inside the body in
order to provide liver functions to the patient. In addition, our bioartificial
liver system is designed to lower the levels of pathological blood components
(through activated charcoal or other purification sorbents).
Critical
to the HepatAssist-2™ technology is (i) the source and method of procurement of
liver cells, (ii) the cryopreservation, or freezing, of the liver cells, (iii)
the storage of the liver cells, (iv) the proprietary plasma re-circulation
loop
incorporating the cell cartridge and sorbents, and (v) the standard operating
procedure protocols and quality control and programs related to the foregoing.
We currently own or have licensed numerous proprietary technologies and methods
for sourcing and using hepatocytes, which technologies and methods apply to
our
HepatAssist-2™ system. The following addresses our current plans and procedures
regarding viable liver cells (hepatocytes).
Hepatocyte
donors. Ideally,
human hepatocytes should be used in a bioartificial liver. However, there is
a
shortage of organ donors and published data demonstrating that pig liver cells
can outperform other animal and human liver cell lines, including those derived
from liver cancers. In addition, use of human cancer-derived cells raises safety
concerns. At this time, we intend to utilize pig liver cells.
Hepatocyte
harvest. The
founders of Arbios and Circe Biomedical developed certain semi-automated methods
for large-scale harvest of pig hepatocytes. The methods of harvesting and
collecting liver cells are covered by four patents, which patents we either
have
acquired from Circe Biomedical and now own or have licensed from Cedars-Sinai
Medical Center.
Hepatocyte
storage. Hepatocyte
storage, quality control and shipment of cells to treatment sites are best
achieved by use of cell freezing, or cryopreservation. Cryopreservation also
provides greater protection from bacterial and viral contamination because
frozen cells can be stored until microbiologic testing is completed and cells
are then released for clinical use. Prior to use, cells are rapidly thawed
and
their viability is tested. The patented hepatocyte cryopreservation technology
is now owned by us and by Cedars-Sinai Medical Center, which has licensed this
technology to us.
The
pig
liver cells are expected to be harvested from young purpose-bred, pathogen-free,
vaccinated pigs raised in the United States Department of Agriculture, or the
USDA, certified facility specifically for biomedical research purposes. Each
batch of cryopreserved pig liver cells will be released for clinical use only
after proper verification of biosafety and viability/functionality of the cells.
We acquired all of the required laboratory and quality assurance protocols
from
Circe Biomedical, which protocols were previously reviewed by the FDA and deemed
to be in compliance with FDA requirements. We are currently leasing facilities
in which we will be able to house and maintains pigs and surgically acquire
their livers. The facilities, which are still under development, would be used
to monitor the health of these pigs and to assure that the pigs and cells remain
free from infection and meet specific FDA requirements and to harvest the pig
livers. We believe that once suitable modifications and FDA approved leasehold
improvements are implemented and completed, these facilities will be suitable
to
meet our near-term goals for maintaining and harvesting the number of pig livers
that we expect to need until the commercial viability of our products is
established.
HepatAssist-2™
is designed to be used in the same manner as any other plasma therapy device.
In
a typical clinical procedure, the operator will install bioartificial liver
components consisting of the cell cartridge, oxygenator, sorbent detoxification
column(s), and tubing kit, into the blood/plasmaperfusion platform.
Approximately 15 billion viable pig hepatocytes will be seeded into the
extra-fiber space through the cartridge side ports. At the start of treatment,
the platform will be attached to the patient and the bioartificial liver system
will be perfused with the patient’s oxygenated plasma. At the end of treatment,
the disposables will be discarded in the normal manner that all other
biohazardous waste products (such as syringes and bandages) are handled and
disposed. No special governmental regulations have been required, or are
expected, to dispose of the used cartridges and disposable
products.
We
expect
to demonstrate that during HepatAssist-2™ therapy, substances normally
metabolized by the liver and accumulated in the blood during liver failure
will
diffuse freely across the porous membrane into the compartment containing pig
liver cells. At the same time, products of pig liver cell metabolism will
diffuse back into the plasma compartment and then into the blood circuit. It
is
anticipated that as a result of these two processes, the levels of pathological
and normal blood components present in the patient’s circulation will move
toward normal ranges, thereby facilitating recovery from liver failure.
Additional therapeutic benefits may be provided by blood purification, or
detoxification, therapy. In this mode of therapy, small and large protein-bound
toxins, which accumulate in the blood during liver failure, are expected to
be
removed by sorbents. Blood detoxification is believed to protect the liver,
brain and other organs against further injury, accelerate healing of the native
liver and improve its residual functions. Decreased blood toxicity is also
expected to prolong the life and metabolic activity of pig hepatocytes in the
bioartificial liver modules.
Product
Advantages
We
believe that SEPET™ as a blood purification therapy will be more effective than
sorbent-based devices such as charcoal, resin and silica, and more effective
than whole plasma exchange therapy, because only the plasma fraction containing
known toxins of hepatic failure is being removed and discarded during SEPET™
therapy. In contrast, sorbent-based blood purification is not toxin-specific,
and in the case of charcoal sorption it is limited because of the protective
coating of the charcoal particles. It also fails to remove most mediators of
inflammation and protein bound toxins from the blood which are associated with
liver failure. Subject to the successful completion of clinical trials and
FDA
or other regulatory approval, we believe that SEPET™ will be able to be used
with currently available hospital kidney dialysis systems, which may offer
the
following advantages:
· |
Ease
of use.
The systems bring user friendliness (e.g., pump integration, automation
and an intuitive user interface) to traditionally complex liver support
procedures.
|
· |
Simplicity.
Kidney dialysis systems are routinely used and, therefore, there
may be no
need for extensive personnel training for use of these similar systems
in
SEPET™. They are also commonly available in intensive care units and other
settings where SEPET™ may be used.
|
· |
Low
cost.
The cost of therapy is expected to be lower than with any other liver
assist device that is currently under development because the machine
to
which the SEPET™ cartridge can be attached is a standard machine (such as
a kidney dialysis machine) with commercially available tubing. Therefore,
unlike other devices, no special equipment is
required.
|
· |
No
Intensive Care Unit needed to provide treatment.
SEPET™ may become available for treatment of patients with a lower degree
of liver failure outside of the intensive care unit setting. We do
not
believe that any changes will have to be made to SEPET™ or the dialysis
system in order for SEPET™ to become available outside of intensive care
unit settings.
|
To
our
knowledge, HepatAssist-2™ is the only liver assist device under development that
is capable of providing both liver cell functions and blood purification either
simultaneously or sequentially in a versatile and customized manner depending
on
the cause and severity of liver failure.
Drs.
Demetriou and Rozga, the founders of Arbios and the major stockholders of the
company, have previously demonstrated that cryopreserved pig hepatocytes remain
alive (>80% viability) after thawing. Moreover, the hepatocytes quickly
aggregate, forming liver-like 3-dimensional cellular units, and resume basic
functions (e.g., drug metabolism) at levels comparable to those seen in intact
livers. Drs. Demetriou and Rozga have also reported that treatment of animals
and patients with fulminant hepatic failure with a bioartificial liver loaded
with freshly thawed pig hepatocytes prolonged life, alleviated intracranial
hypertension and improved blood chemistry. In addition, in experimental animals,
bioartificial liver therapy improved native liver function and triggered
mechanisms regulating liver regeneration. In addition, because porcine
hepatocytes can be stored frozen at a clinical site, treatment with our
bioartificial liver system can be commenced with two to three hours of patient
consent and product preparation, thereby making this bioartificial liver therapy
available on demand. In instances of liver failure, this rapid availability
of
therapy should be a critical competitive advantage. In contrast, we believe
other liver assist devices under development require longer time for preparation
prior to patient treatment (up to several days in some instances, including
cumbersome means of shipment to the clinical site).
Clinical
Utility
We
believe that the animal and clinical data generated and published to date on
the
original HepatAssistTM
system
indicate that the basic concept of a bioartificial liver utilizing cryopreserved
pig liver cells and blood detoxification is valid and that repeated six-hour
bioartificial liver treatments are safe and yield measurable therapeutic
benefits. Accordingly, we believe that our novel, next-generation products
will
represent improvements and/or enhancements of earlier technologies.
Our
HepatAssist-2™ Bioartificial Liver System is an enhanced version of the original
HepatAssist® system. The safety and efficacy of the original HepatAssist® system
were evaluated in a prospective, randomized, controlled, multi-center
FDA-approved clinical trial. A total of 171 patients, 86 in the control group,
and 85 in the bioartificial liver group, were enrolled. Patients with fulminant
and subfulminant hepatic failure and primary non-function following liver
transplantation were included. Data were analyzed with and without accounting
for the following confounding factors: liver transplantation during the survival
endpoint period, time to liver transplant, cause of the disease or condition,
disease severity, and treatment site. For the entire patient population,
survival at 30 days was 71% for bioartificial liver compared to 62% for the
control group. When survival was analyzed accounting for confounding factors
such as liver transplantation and survival prior to transplantation, across
the
entire patient population, there was thus a trend towards improved survival
but
not a statistically significant difference between the two groups. However,
survival in the 147 fulminant and subfulminant hepatic failure patients (i.e.
excluding the primary non-function patients) was significantly higher in the
HepatAssist™ Bioartificial Liver System group compared to the control group.
Furthermore, HepatAssist™ therapy reduced the risk of pre-transplant death by
67% in patients with drug and chemical toxicity (p<0.0140) and by 47% in
patients with rapid onset of fulminant hepatic failure (n=121; p<0.0428) To
our knowledge, this was the first prospective, randomized, controlled trial
of
an extracorporeal liver support system that demonstrated safety and improved
survival in patients with fulminant and subfulminant hepatic
failure.
Market
Opportunity
Based
on
the number of patients with liver diseases and lack of alternative direct
therapy other than liver transplantation, we believe that there is an urgent
need for artificial means of liver replacement and/or assistance to facilitate
recovery from liver failure without a transplant. Effective liver support
therapies could also help maintain liver failure patients’ lives until an organ
becomes available for transplantation. The SEPET™ Liver Assist Device and
HepatAssist-2™ Bioartificial Liver System are designed to treat patients with
liver failure across the range of all causes and severity, including acute
exacerbation of chronic liver disease.
The
patient and market opportunity is substantial and underserved. According to
the
American Liver Foundation, 25,000,000 Americans - one in every ten persons
- are
or have been suffering from liver and biliary diseases. According to the
National Center for Health Statistics published for 2000, there were 360,000
hospital discharges for patients with chronic liver disease or cirrhosis plus
additional patients categorized as suffering from viral hepatitis B or hepatitis
C with likely liver failure sequellae. Of the 360,000 documented
hospitalizations for chronic liver disease in the United States referenced
above, 27,035 died (making liver failure the tenth leading cause of death in
males and twelfth in females, and fourth leading cause of death in persons
aged
45 - 54 years) because no donor liver was found or because they had
contraindications to transplantation.
The
mounting crisis of viral hepatitis B and hepatitis C is projected to continue
to
propel numbers of liver failure episodes as patients age and increasingly suffer
hepatic decompensation. Approximately 3.9 million Americans are chronically
infected with the hepatitis C virus, and an estimated 25,000 people each year
are infected in the United States each year with the hepatitis C virus. At
the
same time, 10,000 - 12,000 deaths have occurred annually in the United States
due to hepatitis C virus infection, and the number is likely rising. Hepatic
decompensation, as a result of chronic hepatitis C virus infection, is now
the
leading cause of liver transplantation in the United States. Despite improved
rates of organ donation, increased utilization of deceased donor livers and
a
resurgence in living donor transplants, the number of liver transplants
performed yearly is now approximately 5,500. At the same time, in 2004 alone
there were more than 10,000 new waitlist registrations for liver replacement.
As
of March 6, 2006, the liver transplant waiting list contained 17,650
individuals. According to National Institutes of Health and the American
Association for the Study of Liver Diseases, 5,000 deaths occur annually as
a
consequence of hepatitis B virus infection.
Worldwide,
hepatitis B is the leading cause of liver failure. Of the 2 billion people
who
have been infected with the hepatitis B virus, more than 350 million are
estimated to have chronic, or lifelong, infections. These chronically infected
persons are at high risk of death from cirrhosis of the liver and liver cancer.
The World Health Organization estimates very large numbers of deaths worldwide
from hepatitis B virus infection -- an estimated 880,000 per year from liver
failure and another 320,000 per year from liver cancer (some of whom may require
liver support therapy before and/or after surgical resection of the cancer).
Infection is most common in Asia, Africa and Middle East. Hepatitis C is also
a
major cause of liver failure worldwide. According to the World Health
Organization, globally, an estimated 170 million persons are chronically
infected with the hepatitis C virus. At the same time, an estimated 3 to 4
million persons are newly infected each year. Liver failure has recently been
cast, worldwide, as the third leading cause of death. In China and other Asian
countries, liver disease represents a pressing health problem and the need
for
an effective liver support therapy is more urgent than in some other markets.
Although epidemiological data on hepatitis C virus and hepatitis B virus
infection in China are not publicly available, we believe there are
approximately 200 million carriers of the hepatitis virus B or C in China,
and
primary liver cancer is a common malignancy.
At
present, no direct treatment for liver failure is available and such patients
must receive a liver transplant or endure prolonged hospitalization with
significant mortality. Moreover, no prognostic test is available that would
help
predict which liver failure patient is likely to survive on medical therapy
alone. Due to the critical nature of liver failure and the resulting adverse
effects on other organs, the hospitalization costs can be as high as $20,000
per
day. In fact, it is estimated that the in-patient cost of liver failure
treatment can reach $200,000 per episode without a transplant. While liver
transplants have significantly increased the chances of survival for patients
with liver failure, due to a severe shortage of donor livers, less than 10%
of
liver failure patients received a transplant. Further, many liver failure
patients were excluded from the waiting list because of alcohol or drug abuse,
cancer, cardiovascular disease or inadequate post-operative support by family
or
others.
At
this
time, based on the preliminary information available to us, we estimate that
the
cost to the provider of a single treatment with the SEPET™ therapy could be
within a $2,000 - $4,000 range and that the respective cost of the bioartificial
liver therapy could be approximately $20,000 in the United States. Pricing
in
other world regions will likely vary. We anticipate that SEPET™ and/or
bioartificial liver therapy may have to be repeated in some patients up to
an
average of five to seven times before a satisfactory clinical outcome is
obtained, although fewer treatments per patient may be sufficient depending
on
the severity of disease. Based on these estimates and the above mentioned
projections, the potential U.S. market for SEPET™ and HepatAssist-2™ is
significant, with similar or possibly larger opportunities in some regions
outside North America. However, we have not confirmed the potential size of
these markets through an independent marketing study.
If
we are
successful in demonstrating the clinical utility of one or both of our products,
liver failure patients treated with our products may be spared liver
transplantation and the need for life-long immune-suppression. In addition,
these patients can be treated outside of the intensive care unit and could
be
discharged from the hospital after shorter stays, all of which would reduce
costs for healthcare providers and generate a demand for the use of these
products.
Sales,
Marketing & Distribution
We
currently do not have any agreements in place to market any of our products
if
and when those products are commercially released, and we do not currently
expect to establish an in-house marketing and sales program to distribute our
products in all regions of the world. We currently expect to outsource at least
a portion of the sales, marketing and distribution of our products to third
parties who specialize in the sales, marketing and distribution of medical
products. Alternatively, we may enter into strategic alliances with larger
medical companies or license the rights to our products to such larger
companies. We currently expect that our products will be marketed in at least
North America, Europe and Asia.
Manufacturing
We
currently do not have a manufacturing arrangement for the cartridges used in
the
HepatAssist-2™ system. However, the HepatAssist-2™ cartridge is based on a
conventional single-bundle hollow-fiber technology and a number of third party
manufacturers, including Spectrum Laboratories, could produce these cartridges
for us under contract.
With
respect to cartridges that we expect will be needed for SEPET™, we anticipate
that such cartridges will be commercially manufactured by either Spectrum
Laboratories or a manufacturer of clinical hemodialyzers. Additional disposable
components, such as tubing kits, may also be manufactured by third party
subcontractors.
The
kidney dialysis hardware units that will be used as a platform for
SEPETTM
therapy
are not expected to require any technical adjustments. Since pressure monitors
and hemoglobin detectors are standard in kidney dialysis systems, additional
safety features are not likely to be required. Since the existing kidney
dialysis units will not be affected, only the kidney dialysis cartridge will
be
replaced by a SEPETTM
cartridge, no consents will have to be obtained from the manufacturers of those
units, and no additional insurance is expected to be required to use those
units.
The
platform we currently expect to use for the HepatAssist-2™ bioartificial liver
therapy is a perfusion platform known as the PERFORMER. The PERFORMER is a
multi-function integrated system capable of supporting extracorporeal
blood/plasma/fluid circulation therapies that is manufactured by RanD S.r.l.
(Italy) and distributed by Medtronic, Inc. The PERFORMER may be equipped with
proprietary software, which has already been developed by RanD for Arbios,
and a
tubing set for use with our HepatAssist-2™ system.
The
pig
liver cells will be harvested from young purpose-bred, pathogen-free, vaccinated
pigs raised in a USDA certified facility specifically designed for biomedical
research purposes. The liver cells will be harvested and cryopreserved under
aseptic conditions using our proprietary technology as well as commercially
available equipment.
With
regard to cell procurement and cryopreservation for bioartificial liver use,
we
do not yet own or lease our own specialized and certified bio-secure porcine
liver cell manufacturing plant. Prior to of Phase III clinical testing of
HepatAssist-2™, we will determine whether to build a cell procurement facility
to meet the expected requirements for commercial sales, which will require
a
substantial lease obligation and/or capital investment. This decision will
be
based on technical evaluation of the project as well as an economic evaluation
of company performance.
In
December 2001 we entered into a manufacturing and supply agreement with Spectrum
Laboratories, Inc. for the future manufacture a portion of our LIVERAID™
product, a potential variation on the HepatAssist™ product design. The LIVERAID™
cartridge is a bioartificial liver similar to the HepatAssist cartridge with
the
exception of its fiber within a fiber design. Under that agreement, we agreed
that Spectrum Laboratories will manufacture the hollow fiber cartridges with
fiber-in-fiber geometry that we will need for the LIVERAID™ bioartificial liver.
The agreement provides that the price of the hollow fiber-in-fiber cartridges
to
be sold by Spectrum Laboratories to us will be determined by good faith
negotiations between the parties. We have agreed that we will not purchase
cartridges with fiber-in-fiber geometry from any other manufacturer unless
Spectrum Laboratories is either unable or unwilling to manufacture the
cartridges. The final step in manufacturing the LIVERAID™ cartridges is
completed manually, which has resulted in a high incidence of rejected
cartridges and a lengthy manufacturing period. These problems, if not remedied,
may limit the amount and timeliness of cartridges that can be manufactured.
Spectrum Laboratories has informed us that it can, and is willing to, acquire
or
develop an automated manufacturing process for the LIVERAID™ cartridges.
However, since such an automated manufacturing process is expensive, Spectrum
Laboratories has not yet undertaken to acquire or develop the necessary
equipment and technology. No assurance can be given that Spectrum Laboratories
will, in fact, be able to acquire or develop an automated manufacturing process
or that Spectrum Laboratories will otherwise be able to satisfy our needs for
the LIVERAID™ cartridges. In the event that Spectrum Laboratories is either
unable or unwilling to manufacture the amount of LIVERAID™ cartridges that we
need, we will have to find one or more alternative manufacturers for the
cartridges. While we have identified other possible manufacturers of the
LIVERAID™ cartridges, it is uncertain if any of those other companies would want
to manufacture the cartridges for us, and if so, on what terms. As such, we
have
decided to stop further development of the LIVERAIDTM
technology
indefinitely and focus on the HepatAssist-2TM
product.
Patents
and Proprietary Rights
Bioartificial
Liver Rights.
We
originally obtained exclusive, worldwide rights from Cedars-Sinai Medical Center
and Spectrum Laboratories to seven issued U.S. patents protecting our
bioartificial liver technology and accompanying cell
procurement/cryopreservation technologies. One of the patents we licensed from
Spectrum Laboratories, Inc., patent #5,015,585 “Method and Apparatus for
Culturing and Diffusively Oxygenating Cells on Isotropic Membranes” has
expired.
The
founders of Arbios, Drs. Rozga and Demetriou, are co-inventors of both the
semi-automated methods for large-scale production of isolated pig/human
hepatocytes and cryopreservation of isolated pig/human hepatocytes. Currently,
the key proprietary bioartificial liver technologies that we intend to use
include the following licensed patents:
|
(1)
|
A
bioartificial liver system in which liver cell therapy and blood
detoxification are integrated in a single fiber-in-fiber module (US
Patent
# 6,582,955 B2 for “Bioreactor With Application as Blood Therapy Device”
issued in June 2003). We have licensed this patent from Spectrum
Laboratories.
|
|
(2)
|
Semi-automated
large-scale liver cell procurement technology (US Patent #5,888,409
for
“Methods for Cell Isolation and Collection” issued on March 30, 1999). We
licensed this patent from Cedars-Sinai Medical
Center.
|
|
(3)
|
Liver
cell procurement technology (US Patent #5,968,356 for “System for
Hepatocyte Cell Isolation and Collection” issued on October 19, 1999, and
related European Patent #0 830 099 for “Apparatus and Method for Cell
Isolation and Collection”). We licensed this patent from Cedars-Sinai
Medical Center.
|
|
(4)
|
Liver
cell cryopreservation technology (US Patent #6,140,123 for “Method for
Conditioning and Cryopreserving Cells” issued on October 31, 2000). We
licensed this patent from Cedars-Sinai Medical
Center.
|
Cedars-Sinai
Medical Center Licenses.
On June
19, 2001, Arbios entered into an agreement with Cedars-Sinai Medical Center
pursuant to which Cedars-Sinai granted to Arbios exclusive and worldwide rights
to patents (2)-(4) above and to certain other technical information. These
rights are and remain exclusive over the legal life of the various patents
and
include, subject to limitations, the right to sublicense the patent rights
to
third parties. In order to maintain its rights under the license, Arbios is
required to expend an aggregate amount of $1,760,000 in research and development
expenses toward the development and promotion of products derived from the
patents. As of the end of the fiscal year ended December 31, 2004, we had
expended more than the minimum required $1,760,000 and have, therefore, fully
satisfied the research and development expenditure requirement of this license.
Cedars-Sinai Medial Center will have nonexclusive rights to any products derived
from the patents. We will have to initially pay Cedars-Sinai Medical Center
royalty fees equal to 1.5% of the gross sales price of royalty bearing products.
From the third to tenth years of the license, the royalty fee percent will
phase
out evenly to 0%. Cedars-Sinai Medical Center is a stockholder of this company.
See “Certain Relationships and Related Transactions.”
Spectrum
Laboratories License Agreement.
On
December 26, 2001, Arbios entered into a license agreement with Spectrum
Laboratories, pursuant to which Spectrum Laboratories granted to Arbios an
exclusive, worldwide license to develop, make, use and distribute products
based
on Spectrum Laboratories’ hollow fiber-in-fiber technology, solely for
applications in Arbios’ liver assist devices. The license includes the rights to
two issued patents which have since expired. Provided that Arbios purchases
the
hollow fiber cartridges that it expects that it will need for its products
from
Spectrum Laboratories, Arbios will not have to pay a royalty for the license.
In
the event that Spectrum Laboratories is not the manufacturer of the hollow
fiber
cartridges, Arbios will have to pay Spectrum Laboratories a royalty for the
license. Unless the Spectrum Laboratories license agreement is terminated sooner
due to a breach of the license, the term of the license will continue until
the
expiration of the two patents. Spectrum Laboratories also agreed to grant Arbios
a right of first refusal to obtain a license to make, use, develop or distribute
products based on Spectrum Laboratories’ technology other than in liver assisted
products, provided that such other products are in the fields of artificial
blood therapy and bioprocessing and therapeutic devices. See “Certain
Relationships and Related Transactions.”
Circe
Biomedical Properties.
In April
2004, we acquired from Circe Biomedical a portfolio of intellectual properties,
including certain U.S. and foreign patents applicable to the HepatAssist
bioartificial liver that Circe Biomedical was developing, including various
patents related to the harvesting and handling of cells to be used in the
bioartificial liver. We also acquired a number of other patents and rights
related to Circe Biomedical’s bioartificial liver program that we will not be
using, as well as patents on other technologies that we do not intend to pursue
(such as patents to Circe Biomedical’s artificial pancreas system and three
patents for cholesterol removal membranes). The following is a list of the
patents and patent applications that we acquired from Circe Biomedical and
that
we expect to maintain and use with our bioartificial liver systems:
|
(1)
|
Apparatus
for Bioprocessing a Circulating Fluid. US Patent #5643794 (issued
on July
1, 1997).
|
|
(2)
|
Cryopreserved
Hepatocytes and High Viability and Metabolic Activity. US Patent
#5795711
(issued on August 18, 1998).
|
|
(3)
|
Closed
System for Processing Cells. US Patent #5858642 (issued on January
12,
1999).
|
|
(4)
|
Method
of Thawing Cryopreserved Cells. US Patent #5895745 (issued on April
20,
1999).
|
|
(5)
|
High
Flow Technique for Harvesting Mammalian Cells. US Patent #5912163
(issued
on June 15, 1999).
|
|
(6)
|
Removal
of Agent From Cell Suspension. US Patent #6068775 (issued on May
30,
2000).
|
|
(7)
|
Method
for Cryopreserving Hepatocytes. US Patent #6136525 (issued on October
24,
2000).
|
Patent
Applications
Patent
No.
|
Country
|
Title
of Patent Application
|
2216203
|
CA
|
Method
of Thawing Cryopreserved Cells
|
9-256534
|
JP
|
Method
of Thawing Cryopreserved Cells
|
97307459
|
EU
|
Method
of Thawing Cryopreserved Cells
|
99106212.6-2113
|
EU
|
Removal
of Agent From Cell Suspension
|
In
addition to the foregoing Circe Biomedical patents, we acquired other rights
to
Circe Biomedical’s HepatAssist bioartificial liver and related technologies,
such as clinical and marketing data and over 400 manufacturing and quality
assurance/control standard operation protocols that the FDA had previously
reviewed. The Phase I-III clinical data that we acquired is expected to be
useful in the preparation of future FDA submissions, since the data is based
on
pig liver cells from the same source. We also acquired an FDA Phase III IND
for
an enhanced version of the HepatAssist system. We are currently evaluating
the
possibility of conducting clinical studies of the HepatAssist-2™ system under a
modified version of the FDA-approved Phase III IND protocol that we acquired.
In
connection with our acquisition of the foregoing patents, we also assumed Circe
Biomedical’s obligations to make the following royalty payments:
(a) We
assumed the obligation to pay a royalty of 2% of “net sales” of any product that
utilizes or incorporates the bioartificial liver patents, technology,
inventions, and technical or scientific data that Circe Biomedical acquired
from
W.R. Grace & Co. pursuant to that certain Royalty Agreement, dated as of
January 29, 1999, between Circe Biomedical (as a wholly-owned subsidiary of
W.R.
Grace & Co.) and Circe Acquisition Corp., Since the assets that we acquired
from Circe Biomedical are expected to be used in the HepatAssist-2™ system, it
is likely that we will have to pay this royalty with respect of sales of those
parts of our HepatAssist-2TM
Bioartificial
Liver System that incorporate the W.R. Grace & Co. technology. Net sales
include revenues received from our licensees and sublicensees from third
parties. The obligation to pay royalties on the net sales of certain parts
of
our bioartificial liver systems will continue for at least ten years after
the
date on which we have obtained all required regulatory approvals and have
received $100,000 of net sales.
(b) We
are
obligated to make royalty payments equal to 1% of the "net sales" price for
that
portion of a liver assist system sold by us or any of our sublicensees that
comprises or incorporates a cartridge having a combination of porcine
hepatocytes with hollow fiber membranes pursuant to that certain Restated
License Agreement dated as of August 1, 1999 between Circe Biomedical and
Cedars-Sinai Medical Center. Since our HepatAssist-2TM
Bioartificial Liver System may utilize this type of cartridge, we will have
to
pay this royalty with respect of sales of all cartridges used in our
bioartificial liver system. Our obligation to pay these royalties will begin
with the first commercial sale of a bioartificial liver and continue thereafter
for ten years.
Under
U.S. law, utility patents filed before June 8, 1995 are valid for 20 years
from
the filing date, or 17 years from date of issuance, whichever period is longer.
Patents filed on or after June 8, 1995 are good for 20 years from the date
of
filing.
SEPETTM
Rights.
Our
intellectual property rights relating to the SEPETTM
Liver
Assist Device consist of a patent application and certain related trade secrets.
Our patent application regarding our selective plasma filtration therapy
(SEPET™) technology was filed in August 2002 with the United States Patent and
Trademark Office and subsequently in other countries and is currently under
review for possible issuance.
We
have
filed for trademark protection for our product names, SEPET™ and HepatAssist-2™,
which marks may become registered only upon commercialization of
products.
Research
and Development
In
December 2001, Arbios and Spectrum Laboratories entered into a four-year
research agreement pursuant to which Arbios and Spectrum Laboratories agreed
to
combine their expertise and their respective technologies to enable Arbios
to
(i) develop liver assist systems, (ii) conduct pre-clinical and Phase I-III
clinical testing, (iii) obtain regulatory approvals, and (iv) commercialize
such
liver assist systems. Under the terms of the agreement, Spectrum Laboratories
agreed to perform certain research on liver assist devices for Arbios during
product development, pre-clinical and clinical testing at no cost to Arbios.
Although all of the obligations of the parties under that research and
development agreement were completed during the fiscal year ended December
31,
2004, Spectrum Laboratories has agreed to perform such additional research
and
development work as we may request, which additional future work will be
provided by Spectrum Laboratories on terms upon which we may agree in the
future.
We
spent
a total of $1,555,000 on research and development during the fiscal year ended
December 31, 2005, $1,426,000 on research and development during the fiscal
year
ended December 31, 2004, and $437,000 on research and development during the
fiscal year ended December 31, 2003. In addition, pursuant to our research
agreement with Spectrum Laboratories, Spectrum Laboratories provided research
and development services valued at $17,260 in 2003 for our liver assist systems.
See, “Certain Relationships and Related Transactions.”
In
January 2005, we entered into a research and development agreement with the
Faculty of Chemical and Process Engineering of the Warsaw University of
Technology, in Warsaw, Poland. Pursuant to this agreement, Warsaw University
agreed to provide research to and develop services for us in connection with
the
development and manufacture of new membrane-based selective plasma filtration
technologies and new selective plasma filtration devices to be used with our
liver assist devices. The research agreement had a term of one year and could
be
extended by the parties. The cost of the research and development agreement
to
us during FY 2005 was approximately $100,000, and the agreement was terminated
In February 2006 for failure to meet the final milestone
objectives.
Competition
Our
products will compete with numerous other products and technologies that are
currently used or are being developed by companies, academic medical centers
and
research institutions. These competitors consist of both large established
companies as well as small, single product development stage companies. We
expect substantial competition from these companies as they develop different
and/or novel approaches to the treatment of liver disease. Some of these
approaches may directly compete with the products that we are currently
developing.
Other
therapies currently available include whole plasma exchange therapy, a procedure
involving massive plasma transfusions that is being used primarily for
correction of coagulopathy in patients with severe acute liver failure. In
addition, two extracorporeal blood detoxification systems are currently
available in the United States for treatment of liver failure: (1) the Adsorba
column (Gambro, Hechingen, Germany) which contains activated charcoal and (2)
the BioLogic-DT system (HemoCleanse, West Lafayette, Indiana) utilizing a
mixture of charcoal, silica and exchange resins.
Published
data indicate that in limited, uncontrolled clinical trials utilizing these
systems, only a transient improvement in neurological status was observed with
no effect on patients’ survival.
Other
technologies offered by competing companies include the following:
Gambro’s
MARS system (molecular adsorbents recirculating system) combines the specific
removal of the toxins of liver failure (albumin bound toxins) using a
hollow-fiber cartridge impregnated with albumin, and sorbent columns placed
in a
dialysis circuit filled with 20% albumin solution. Albumin in the dialysate
is
"regenerated" during continuous recirculation in the closed loop system through
sorbent columns (charcoal, resin). In addition, standard hemodialysis is
performed during MARS treatment. In Europe, initial results in patients with
acute liver failure were encouraging. In November 2004, Gambro announced that
in
a recently completed Phase II controlled study, which was conducted in 79
patients with acute exacerbation of chronic liver disease, MARS treatment
improved hepatic encephalopathy and lowered blood levels of certain toxins
implicated in the pathophysiology of liver failure.
Fresenius’s
PROMETHEUS system is a variant of the MARS system and also combines albumin
dialysis with sorbent based blood detoxification and dialysis. In Europe,
initial results in a small group of patients with acute exacerbation of chronic
liver failure appeared encouraging. Controlled clinical trials are needed to
establish if the technology has any therapeutic value and also needed for
registration of the product in the United States.
Vital
Therapies, Inc. uses technology developed by Hepatix and VitaGen, Inc. Its
bioartificial liver ELAD®
utilizes
a cell line derived from human liver cancer tissue and a conventional hollow
fiber bioreactor. A Phase I clinical study of the newest ELAD®
version
was recently reported at the annual meeting of the American Association for
the
Study of Liver Disease in November 2004 in Boston. In patients with acute liver
failure, treatment with ELAD®
had no
effect on survival when compared to patients receiving standard therapy. In
January 2006, Vital Therapies, Inc. announced that it had received guidance
from
the FDA to allow it to begin shipment of its ELAD®
cartridges to China in anticipation of pivotal clinical trials scheduled to
begin in China in early 2006.
Several
other technologies could potentially compete with our bioartificial liver
systems. These include xenotransplantation, which is the use of pig or other
animal organs in humans, transplantation of isolated hepatocytes and
ex
vivo
whole
liver perfusions. While major progress has been made in the area of
xenotransplantation and transgenic pigs are now available, attempts at
xenotransplantation have resulted only in short-term survival of grafted organs.
Ex
vivo
whole
liver perfusion is impractical because it is cumbersome and requires maintenance
of multiple pathogen-free pig colonies due to direct cell-cell contact between
pig liver and human blood cells. Although transplantation of hepatocytes showed
great promise in animal models of liver failure, there is no adequate supply
source of human cells due to shortage of organ donors.
Government
Regulation
In
order
to clinically test, manufacture, and market products for therapeutic use, we
will have to satisfy mandatory procedures and safety and effectiveness standards
established by various regulatory bodies. In the United States, the Public
Health Service Act and the Federal Food, Drug, and Cosmetic Act, as amended,
and
the regulations promulgated thereunder, and other federal and state statutes
and
regulations govern, among other things, the testing, manufacture, labeling,
storage, record keeping, approval, advertising, and promotion of our products.
Product development and approval within this regulatory framework take a number
of years and involve the expenditure of substantial resources. After laboratory
analysis and preclinical testing in animals, an IND is filed with the FDA to
begin human testing. Typically, a three-phase clinical testing program is then
undertaken. In phase 1, small clinical trials are conducted to determine the
safety of the product. In phase 2, clinical trials are conducted to assess
safety and gain preliminary evidence of the efficacy of the product. In phase
3,
clinical trials are conducted to provide sufficient data for the statistically
valid proof of safety and efficacy. The time and expense required to perform
this clinical testing can vary and be substantial. No action can be taken to
market any new drug or biologic product in the United States until an
appropriate marketing application has been approved by the FDA. Even after
initial FDA approval has been obtained, further clinical trials may be required
to provide additional data on safety and effectiveness and are required to
gain
clearance for the use of a product as a treatment for indications other than
those initially approved. In addition, side effects or adverse events that
are
reported during clinical trials can delay, impede, or prevent marketing
approval. Similarly, adverse events that are reported after marketing approval
can result in additional limitations being placed on the product’s use and,
potentially, withdrawal of the product from the market. Any adverse event,
either before or after marketing approval, can result in product liability
claims against us.
In
addition to regulating and auditing clinical trials, the FDA regulates and
inspects equipment, facilities, and processes used in the manufacturing and
testing of such products prior to providing approval to market a product. If,
after receiving clearance from the FDA, a material change is made in
manufacturing equipment, location, or process, additional regulatory review
may
be required. We will also have to adhere to current Good Manufacturing Practice
and product-specific regulations enforced by the FDA through its facilities
inspection program. The FDA also conducts regular, periodic visits to re-inspect
equipment, facilities, laboratories, and processes following the initial
approval. If, as a result of these inspections, the FDA determines that any
equipment, facilities, laboratories, or processes do not comply with applicable
FDA regulations and conditions of product approval, the FDA may seek civil,
criminal, or administrative sanctions and/or remedies against us, including
the
suspension of the manufacturing operations.
The
FDA
has separate review procedures for medical devices before such products may
be
commercially marketed in the United States. There are two basic review
procedures for medical devices in the United States. Certain products may
qualify for a Section 510(k) procedure, under which the manufacturer gives
the
FDA a Pre-Market Notification, or 510(k) Notification, of the manufacturer's
intention to commence marketing of the product at least 90 days before the
product will be introduced into interstate commerce. The manufacturer must
obtain written clearance from the FDA before it can commence marketing the
product. Among other requirements, the manufacturer must establish in the 510(k)
Notification that the product to be marketed is "substantially equivalent"
to
another legally-marketed, previously existing product. If a device does not
qualify for the 510(k) Notification procedure, the manufacturer must file a
Pre-Market Approval Application. The Pre-Market Approval Application requires
more extensive pre-filing testing than the 510(k) Notification procedure and
involves a significantly longer FDA review process. We are currently in the
process of designing clinical trials to demonstrate the safety and efficacy
of
SEPET™ in treating patients with chronic liver failure.
HepatAssist-2™
is classified by the FDA as a combination product comprising a biological
therapeutic and a Class III medical device. Accordingly, it is subject to a
two-step approval process starting with a submission of an IND to conduct human
studies followed by the submission of applications for Product Marketing
Approval (PMA) and Biologic License Approval (BLA). The steps required before
a
product such as HepatAssist-2™ may be approved by the FDA for marketing in the
United States generally include (i) preclinical laboratory and animal tests;
(ii) the submission to the FDA of an IND for human clinical testing, which
must
become effective before human clinical trials may commence; (iii) adequate
and
well-controlled human clinical trials to establish the safety and efficacy
of
the product; and (iv) the submission to the FDA of a product application.
Preclinical tests include laboratory evaluation of the product, as well as
animal studies to assess the potential safety and efficacy of the product.
The
results of the preclinical tests, together with analytical data, are submitted
to the FDA as part of an IND, which must become effective before human clinical
trials may commence. The sponsor and the FDA must resolve any outstanding
concerns before clinical trials can proceed. Human clinical trials typically
involve three sequential phases. Each trial must be reviewed and approved by
the
FDA before it can begin. Phase I involves the initial introduction of the
experimental product into human subjects to evaluate its safety and, if
possible, to gain early indications of efficacy. Phase II usually involves
a
trial in a limited patient population to (i) evaluate preliminarily the efficacy
of the product for specific, targeted indications; (ii) determine dosage
tolerance and optimal dosage; and (iii) identify possible adverse effects and
safety risks. Phase III typically involves further evaluation of clinical
efficacy and testing of product safety of a product in final form within an
expanded patient population. The results of preclinical testing and clinical
trials, together with detailed information on the manufacture and composition
of
the product, are submitted to the FDA in the form of an application requesting
approval to market the product. In the case of HepatAssist2™, the product may be
available for Phase III testing once the new platform to provide therapy (which
we currently believe will be the PERFORMER) is found to be equivalent as a
plasma perfusion apparatus to the original platform used in previous Phase
I/II/III studies, and the FDA agrees to amend the previous IND to use the
PERFORMER in a new Phase III clinical study. No assurance can be given that
the
results of the equivalency studies will show that the PERFORMER is a suitable
platform for the HepatAssist-2™ bioartificial liver. Finally, we will also have
to re-establish an approved cell manufacturing capability or engage an approved
third party provider of pig cells.
In
addition to obtaining FDA approval, we will have to obtain the approval of
the
various foreign health regulatory agencies of the foreign countries in which
we
may wish to market our products. Certain health regulatory authority (including
those of Japan, France and the United Kingdom) have objected, and other
countries regulatory authorities could potentially object, to the marketing
of
any therapy that uses pig liver cells (which our bioartificial liver systems
are
expected to utilize) due to safety concerns. If we are unable to obtain the
approval of the health regulatory authorities in any country, the potential
market for our products will be reduced.
Employees
As
of
April 17, 2006, we employed six full-time employees. We have also engaged six
independent contractors who provide services to us on a part-time basis. Of
the
foregoing employees and contractors, five are primarily engaged in
administration/management, and the remaining seven persons are involved in
scientific research, product development and/or regulatory compliance matters.
Our employees are not represented by a labor organization or covered by a
collective bargaining agreement. We have not experienced work stoppages and
we
believe that our relationship with our employees is good.
Glossary
of Terms
“Dialysate”
is a
cleansing liquid used in the two forms of dialysis—hemodialysis and peritoneal
dialysis.
“Dialysis”
is
the
process of cleaning wastes from the blood artificially. This job is normally
done by the kidney and liver.
“Extracorporeal”
means
situated or occurring outside the body.
“Ex
vivo” pertains
to a biological process or reaction taking place outside of a living cell or
organism.
“Fulminant”
means
occurring suddenly, rapidly, and with great severity or intensity.
“Hemodialysis”
pertains
to the use of a machine to clean wastes from blood after the kidneys have
failed. The blood flows through a device called a dialyzer, which removes the
wastes. The cleaned blood then flows back into the body.
“Hemofiltration/
Hemofiltrate
"Hemofiltration" is a continuous dialysis therapy in which blood is pumped
through a hollow-fiber cartridge and the liquid portion of blood containing
substances are removed into the sink compartment. The liquid portion of the
blood ("hemofiltrate") is discarded.
“Hepatitis”
is
an
inflammation of the liver caused by infectious or toxic agents.
“Hepatocytes”
are
the
organ tissue cells of the liver.
“kDa”
is
a
measure of molecular weight using “Daltons” (abbreviated as “Da”). One “Da” is
1/12 of the weight of an atom carbon 12C.
“kDa”
is a kilodalton, or a 1,000 Daltons.
“IND”
means
Investigational New Drug application.
“In
vitro”
pertains
to a biochemical process or reaction taking place in a test-tube (or more
broadly, in a laboratory) as opposed to taking place in a living cell or
organism.
“In
vivo”
pertains
to a biological process or reaction taking place in a living cell or
organism.
“PERV”
means
the porcine endogenous retrovirus.
“Plasma”
is the
clear, yellowish fluid portion of blood. Plasma differs from serum in that
it
contains fibrin and other soluble clotting elements.
“Porcine”
means
of
or pertaining to swine; characteristic of the hog.
“Regeneration”
means
regrowth of lost or destroyed parts or organs.
“Sorbent”
means
to
take in and adsorb or absorb.
Property
Since
April 1, 2004, we have been leasing 1,700 square feet of administrative office
space in a building across the street from our laboratories that are located
at
Cedars-Sinai Medical Center. Our office is located at 8797 Beverly Blvd., Suite
304, Los Angeles, California 90048. On September 1, 2005, we re-signed the
lease
for an additional two years. The office lease requires us to pay rent of $5,777
per month. Since December 5, 2005, we have been leasing approximately 600 square
feet of administrative office space in Waltham, Massachusetts where some of
our
executive management are located. The new office lease, located at 1050 Winter
Street, Suite 1000, Waltham, Massachusetts 02154, requires us to pay a total
of
$18,040 for a period of seven months. We also lease an animal breeding facility
in Woodstock, Connecticut which will be used to harvest porcine livers for
use
in our HepatAssist-2 product. The animal breeding facility lease in Connecticut
commenced on April 1, 2005 and has a term of two years which requires us to
pay
$12,009 per month for approximately 1,680 square feet of space.
Legal
Proceedings
We
may
occasionally become subject to legal proceedings and claims that arise in the
ordinary course of our business. It is impossible for us to predict with any
certainty the outcome of pending disputes, and we cannot predict whether any
liability arising from pending claims and litigation will be material in
relation to our consolidated financial position or results of
operations.
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS
AND
CONTROL PERSONS
Directors
and Executive Officers of Arbios Systems, Inc.
The
following table sets forth the name, age and position held by each of our
directors and executive officers. Directors are elected at each annual meeting
and thereafter serve until the next annual meeting (currently expected to be
held during the third calendar quarter of 2006) at which their successors are
duly elected by the stockholders. Pursuant to the stock purchase agreement
signed by the Company and investors during the March 6, 2006 private equity
financing, it was agreed upon that no more than nine director nominees shall
be
elected at the next annual shareholders meeting.
Name
|
Age
|
Position
|
|
|
|
Walter
C. Ogier
|
49
|
Director,
President and Chief Executive Officer
|
|
|
|
Jacek
Rozga, M.D., Ph.D.
|
57
|
Director,
Chief Scientific Officer
|
|
|
|
Roy
Eddleman
|
66
|
Director
|
|
|
|
Marvin
S. Hausman M.D.
|
64
|
Director
|
|
|
|
John
M. Vierling, M.D.
(2)
|
60
|
Chairman
of the Board
|
|
|
|
Jack
E. Stover
(1)
|
53
|
Director
|
|
|
|
Thomas
C. Seoh (1)(3)
|
48
|
Director
|
|
|
|
Thomas
M. Tully (1)(2)(3)
|
60
|
Director
|
|
|
|
Dennis
Kogod (2)(3)
|
46
|
Director
|
|
|
|
Richard
W. Bank, M.D.
|
72
|
Director
|
|
|
|
Amy
Factor
|
48
|
Director
|
|
|
|
Scott
L. Hayashi
|
34
|
Vice
President of Administration, Chief Financial Officer and
Secretary
|
|
|
|
David
J. Zeffren
|
49
|
Vice
President of Product Development
|
|
|
|
Shawn
P. Cain
|
39
|
Vice
President of Operations
|
|
|
|
(1) Member
of
Audit Committee.
(2) Member
of
Compensation Committee
(3)
Member
of
Nominating and Corporate Governance Committee.
Business
Experience and Directorships
The
following describes the backgrounds of current directors and the key members
of
the management team.
Walter
C. Ogier. Mr.
Ogier
was appointed President and Chief Executive Officer and a director of Arbios
in
November 2005 and has two decades of experience in the healthcare and
biotechnology industries. Prior to joining Arbios, Mr. Ogier was President
and
Chief Executive Officer of Genetix Pharmaceuticals Inc., which is active in
gene
therapy and functional genomics and was affiliated with Johnson & Johnson,
from December 2001 until November 2005. Prior to that, Mr. Ogier was President
and Chief Executive Officer of Eligix, Inc., a Harvard University-affiliated
company engaged in monoclonal antibody-based therapies for stem cell
transplantation and immune therapy, from October 1997 through November 2001.
Mr.
Ogier was also previously Vice President of Marketing for Aastrom Biosciences
and held various positions within Baxter Healthcare Corporation and its Fenwal
and Immunotherapy divisions and with SRI International (formerly Stanford
Research Institute).
Jacek
Rozga, MD, Ph.D.
Dr.
Rozga is a co-founder of Arbios and has been a director and Chief Scientific
Officer of Arbios since its organization in August 2000. Dr. Rozga served as
President of Arbios from August 2000 until November 2005. From October 2003
until March 2005, Dr. Rozga also acted as our Chief Financial Officer. Dr.
Rozga
is has been a director of Optical Imaging Systems, Inc., a publicly held Nevada
corporation since February 2005 and Chairman of OncoTx, Inc., a private
California corporation since October 2005. Since 1992, Dr. Rozga has been a
professor of Surgery at UCLA School of Medicine. Dr. Rozga was previously a
research scientist at Cedars-Sinai Medical Center from 1992 to
2005.
Roy
Eddleman.
Mr.
Eddleman has served as a director since March 2002. Mr. Eddleman has been the
Chairman of the Board and Chief Executive Officer of Spectrum Laboratories,
Inc.
since July 1982. Spectrum Laboratories, Inc. is a company in the business of
developing and commercializing proprietary tubular membranes and membrane
devices for existing and emerging life sciences applications. Mr. Eddleman
also
has been the founder and/or principal and director of each of (i) Spectrum
Separations, Inc., now a part of UOP/Hitachi, (ii) ICM, Inc., now a part of
Perstorf/Perbio, (iii) Facilichem, Inc., a joint venture with SRI International,
(iv) Nuclepore, Inc., now a part of Corning and Whatman, and (v) Inneraction
Chemical, Inc., now a part of Merck Darmstadt. He is the founder and a
benefactor of the Roy Eddleman Research Museum of Chemistry and the Chemical
Heritage Foundation in Philadelphia.
Marvin
S. Hausman, M.D.
Dr.
Hausman has served as a director since February 2003. From January 1997 until
March 2005, Dr. Hausman was the President and Chief Executive Officer of Axonyx,
Inc., a public company engaged in the business of acquiring and developing
novel
post-discovery central nervous system drug candidates, primarily in areas of
memory and cognition. Dr. Hausman stepped down as the Chairman of the Board
of
Directors of Axonyx, Inc. in June 2005. Dr. Hausman has 30 years of drug
development and clinical care experience at various pharmaceutical companies,
including working in conjunction with Bristol-Meyers International, Mead-Johnson
Pharmaceutical Co., and E.R. Squibb. He was a co-founder of Medco Research
Inc.,
a NYSE-traded biopharmaceutical company which was acquired by King
Pharmaceuticals, Inc. Dr. Hausman has been the President of Northwest Medical
Research Partners, Inc. since 1995 and previously served as a member of the
Board of Directors of Regent Assisted Living, Inc. from 1996 through
2001.
John
M. Vierling, M.D.,
FACP.
Dr.
Vierling has served as a director since February 2002. In April 2005, Dr.
Vierling assumed the position of Professor of Medicine and Surgery, Director
of
Baylor Liver Health and Chief of Hepatology at the Baylor College of Medicine
and Director, Advanced Liver Therapies at St. Luke’s Episcopal Hospital in
Houston, Texas. Dr. Vierling had been a Professor of Medicine at the David
Geffen School of Medicine at UCLA from 1996 to 2005 and was the Director of
Hepatology and Medical Director of Multi-Organ Transplantation Program at
Cedars-Sinai Medical Center from 1990 until 2004. Dr. Vierling is also currently
the President of the American Association for the Study of Liver Diseases.
Dr.
Vierling was the Chairman of the Board of the American Liver Foundation from
1994 to 2000, and the President of the Southern California Society for
Gastroenterology from 1994 to 1995. Dr. Vierling has also been a member of
numerous National Institutes of Health study sections and advisory committees,
including the NIDDK Liver Tissue Procurement and Distribution Program. He is
currently Chairman of the Data Safety Monitoring Board for the National
Institute of Health, NIDDK ViraHep C Multicenter Trial. Dr. Vierling’s research
has focused on the immunological mechanisms of liver injury caused by hepatitis
B and C viruses and autoimmune and alloimmune diseases.
Jack
E. Stover.
Mr.
Stover has served as a director since November 2004. Mr. Stover is also a
director of PDI, Inc. and Antares Pharma, Inc. Mr. Stover was elected the
President and Chief Operating Officer of Antares Pharma, Inc., (a public
specialty pharmaceutical company) in July 2004. In September 2004, he was named
President, CEO and was appointed as a director of that company. Prior thereto,
for approximately two years Mr. Stover was Executive Vice President, Chief
Financial Officer and Treasurer of SICOR, Inc., a Nasdaq traded injectable
pharmaceutical company that was acquired by Teva Pharmaceutical Inc. Prior
to
that, Mr. Stover was Executive Vice President and Director for Gynetics, Inc.,
a
proprietary women’s drug company, and the Senior Vice President, Chief Financial
Officer, Chief Information Officer and Director for B. Braun Medical, Inc.,
a
private global medical device and pharmaceutical company. For over 16 years,
Mr.
Stover was an employee and then a partner with PricewaterhouseCoopers, working
in their bioscience industry division.
Thomas
C. Seoh. Mr.
Seoh
has served as a director since March 2005. Since February 2006, Mr. Seoh has
served as Chief Executive Officer of Faust Pharmaceuticals S.A., a clinical
stage product company focused on drugs for neurological diseases and conditions.
From 2005 to 2006, Mr. Seoh was Managing Director of Beyond Complexity Ventures,
LLC, engaged in life science start-up and business development consulting
activities. From 1995 to 2005, Mr. Seoh was Senior Vice President, Corporate
and
Commercial Development, and previously Vice President, General Counsel and
Secretary, with NASDAQ-listed Guilford Pharmaceuticals Inc., engaged in
research, development and commercialization of CNS, oncology and cardiovascular
products. Previous positions included Vice President and Associate General
Counsel of ICN Pharmaceuticals, Inc., General Counsel and Secretary of
Consolidated Press U.S., Inc. and corporate attorney in the New York City and
London offices of Lord Day & Lord, Barrett Smith.
Thomas
M. Tully. Mr.
Tully
has served as a director since May 2005. Since January 2006, Mr. Tully has
served as Chairman and Chief Executive Officer of IDev Technologies, a medical
device company focused on the development and marketing of innovative minimally
invasive devices for the treatment of peripheral vascular disease. From August
2000 until April 2005, Mr. Tully was the President and Chief Executive Officer
of Neothermia Corporation, a medical device company. Prior thereto, from June
1995 to April 2000, Mr. Tully was the President and Chief Executive Officer
of
Nitinol Medical Technologies, Inc., a medical device company. Mr. Tully was
the
President of Organogenesis Inc., from 1991 to 1994, and the President of
Schnieder (USA) Inc. from 1988 to 1991. From 1980 through 1988 he held various
positions with Johnson & Johnson, including President, Johnson & Johnson
Interventional Systems and Vice President Marketing and Sales at the Johnson
& Johnson Cardiovascular division.
Dennis
Kogod. Mr.
Kogod
has served as a director since May 2005. Mr. Kogod is Division President,
Western Group for Davita, Inc., a leading provider of dialysis services for
patients suffering from chronic kidney failure. Mr. Kogod joined Davita when
that company acquired Gambro Healthcare in October 2005. Prior to the
acquisition, Mr. Kogod was President and Chief Operating Officer of the West
Division of Gambro Healthcare USA, which he joined in July 2000. Before that,
Mr. Kogod spent 13 years with Teleflex Corporation, a NYSE-traded company.
While
there, he served as Division President of the Teleflex Medical Group from
December 1999 to July 2000.
Richard
W. Bank, M.D. Dr.
Bank
has served as a director since January 2006 and was previously a director from
December 2003 to January 2005. Dr. Bank has served as President and Managing
Director of First-Tier Biotechnology Partners since February of 1995. From
February 1995 through April 1996, Dr. Bank served as President and Secretary
of
Biomedical Sciences, Incorporated. He has also served as President and Secretary
of BioVest Health Sciences, Incorporated since its organization in April 1996.
Dr. Bank was Senior Research Analyst Director/Biotechnology SBC Warburg Dillon
Read from 1998 to 1999. He was also Entrepreneur-In- Residence in Life Sciences
for Tucker Anthony Sutro for 2000 through 2001. Dr. Bank has been Senior
Portfolio Manager, Managing Director and Senior Vice President of LibertyView
Capital Management, a Lehman Brothers company, from July 1, 2004 to March 31,
2006 and is currently the President of BioVest Advisors.
Amy
Factor. Ms.
Factor was appointed as a director of Arbios in March 2005, and she was the
interim Chief Executive Officer of Arbios from April 2005 until November 2005.
Prior to her term as the Chief Executive Officer, Ms. Factor provided the
Company with strategic and financial consulting services from November 2003
until March 2005. Since 1999, Ms. Factor has been President of AFO Advisors,
LLC
and the President of AFO Capital Advisors, LLC since 1996. Ms. Factor began
her
career with the public accounting firm KPMG and has been involved in the
biotechnology industry since 1988 serving as the CFO of a publicly traded
biotechnology company.
Scott
L. Hayashi. Mr.
Hayashi joined the company as its Chief Administrative Officer in February
2004,
became the Secretary of the company in July 2004 and was appointed as the Vice
President of Administration in November 2004. In March 2005, Mr. Hayashi assumed
the role as our Chief Financial Officer. Prior to joining Arbios, Mr. Hayashi
was a Manager of Overseas Development for Cardinal Health, Inc. from July 2000
to April 2002, Mr. Hayashi worked in finance, mergers and acquisitions for
Northrop Grumman Corporation from March 1997 to July 2000 and Honeywell, Inc.
from July 1994 to December 1996.
David
J. Zeffren.
Mr.
Zeffren was first employed by us as a consultant in February 2004, before being
appointed Vice President of Operations in November 2004, after which he became
Vice President of Product Development in March 2005. Prior to joining Arbios,
Mr. Zeffren had been the Chief Operating Officer of Skilled Health Systems,
L.C., a healthcare technology and clinical research organization from 1999
to
2004. Mr. Zeffren was also Chief Operating Officer of Physician Care Management
from 1996 to 1999. Mr. Zeffren was a Corporate Director, Business Development
& Division Manager at INFUSX, Inc., a subsidiary of Salick Health Care, Inc.
from 1993-1996. Mr. Zeffren has over 15 years of experience working in the
healthcare and medical device industries.
Shawn
P. Cain.
Mr. Cain
joined the company as its Vice President of Operations in April 2005 and was
previously employed by us as a part-time consultant from December 2003 to March
2005. From June 2003 to March 2005, Mr. Cain was employed at Becton Dickinson’s
Discovery Labware, Biologics Business, where he was responsible for the
operation of two manufacturing facilities that produced over 900 biologics
products. From January 1997 through May 2003, Mr. Cain was the Vice President
of
Operations for Circe Biomedical, Inc., where he was instrumental in the early
development of the bioartificial liver technology, including development the
company’s HepatAssist® product.
There
are
no family relationships between any of the executive officers and
directors.
Audit,
Compensation and Nominating Committees
In
February 2004, our Board of Directors established an Audit Committee. The Board
of Directors has instructed the Audit Committee to meet periodically with the
company’s management and independent accountants to, among other things, review
the results of the annual audit and quarterly reviews and discuss the financial
statements, recommend to the Board the independent accountants to be retained,
and receive and consider the accountants’ comments as to controls, adequacy of
staff and management performance and procedures in connection with audit and
financial controls. The Audit Committee is also authorized to review related
party transactions for potential conflicts of interest. The Audit Committee
consists of three persons and is currently composed of Mr. Stover, Mr. Seoh
and
Mr. Tully. Each of these individuals is a non-employee director and, in the
opinion of our Board, is independent as defined under the Nasdaq Stock Market’s
listing standards. Mr. Stover is our “audit committee financial expert” as
defined under Item 401(e) of Regulation S-B of the Securities Exchange Act
of
1934, as amended. The Audit Committee operates under a formal charter that
governs its duties and conduct. In November 2004, we established a Compensation
Committee and a Nomination Committee. The Compensation Committee is authorized
to review and make recommendations to the full Board of Directors relating
to
the annual salaries and bonuses of our senior executive officers. The Nomination
Committee assists the Board in identifying qualified candidates, selecting
nominees for election as directors at meetings of stockholders and selecting
candidates to fill vacancies on our Board, and developing criteria to be used
in
making such recommendations.
EXECUTIVE
COMPENSATION
The
following table set forth certain information concerning the annual and
long-term compensation for services rendered to us in all capacities for the
fiscal years ended December 31, 2005, 2004 and 2003 of (i) all persons who
served as the Chief Executive Officer of this company during the fiscal year
ended December 31, 2005 and (ii) each other person who was an executive officer
on December 31, 2005 and whose total annual salary and bonus during the fiscal
year ended December 31, 2005 exceeded $100,000. (The Chief Executive Officer
and
the other named officers are collectively referred to as the "Named Executive
Officers.") The information set forth below includes all compensation paid
to
the Named Executive Officers by ATI before the Reorganization by ATI, and all
compensation paid to such individual by both Arbios and ATI since the
Reorganization.
Summary
Compensation Table
|
|
Annual
Compensation
|
|
Long-Term
Compensation
Awards
|
|
|
|
Name
and Principal
Position
|
|
Year
|
|
Salary
|
|
Bonus
|
|
Other
Annual
Compensation
|
|
Securities
Underlying
Options
|
|
All
Other
Compensation(10)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Walter
C. Ogier,(1)
President
and Chief
Executive
Office
|
|
|
2005
|
|
$
|
46,057
|
|
$
|
50,000
|
|
|
|
|
|
500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amy
Factor(2)
|
|
|
2005
|
|
$
|
190,582
|
|
|
--
|
|
$
|
137,750
|
(3)
|
|
300,000
|
|
$
|
1,125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jacek
Rozga, M.D.,
|
|
|
2005
|
|
$
|
199,177
|
|
$
|
24,000
|
|
|
|
|
|
12,000
|
|
$
|
2,750
|
|
Ph.D.,
|
|
|
2004
|
|
$
|
198,909
|
|
$
|
20,000
|
|
|
|
|
|
30,000
|
|
|
|
|
Chief
Scientific Officer
|
|
|
2003
|
|
$
|
143,125
|
|
$
|
15,000
|
|
|
|
|
|
18,000
|
(4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scott
L. Hayashi
|
|
|
2005
|
|
$
|
102,291
|
|
$
|
9,450
|
|
|
|
|
|
22,000
|
|
$
|
1,969
|
|
Vice
President of
Administration,
Chief
Financial
Officer and
Secretary
|
|
|
2004
|
(5)
|
$
|
80,000
|
|
$
|
12,000
|
|
$
|
8,000
|
(6)
|
|
10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David
J. Zeffren
|
|
|
2005
|
|
$
|
114,346
|
|
$
|
5,400
|
|
|
|
|
|
12,000
|
|
$
|
2,080
|
|
Vice
President of
Product
Development
|
|
|
2004
|
(7)
|
$
|
120,000
|
|
|
|
|
|
|
|
|
10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shawn
P. Cain,(8)
Vice
President of
Operations
|
|
|
2005
|
|
$
|
110,000
|
|
$
|
12,000
|
|
$
|
3,465
|
(9)
|
|
30,000
|
|
$
|
3,000
|
|
(1) Mr.
Ogier
was appointed our President and Chief Executive Officer in November
2005.
(2) From
January 2005 to March 2005, Ms. Factor was employed by Arbios Systems, Inc.
as a
consultant and was subsequently appointed as the Chief Executive Officer from
April 2005 until November 2005.
(3) Represents
compensation paid to Ms. Factor for the period from January 2005 until March
2005.
(4) Represents
options granted to Jacek Rozga, M.D., Ph.D. by ATI, which options were assumed
by this company in the Reorganization.
(5) Mr.
Hayashi joined Arbios in February 2004.
(6) Represents
cash payments made to Mr. Hayashi for health and other benefits in
2004
(7) Mr.
Zeffren joined Arbios Systems, Inc. in February 2004 as a consultant before
becoming an executive officer of this company in November 2004. The compensation
shown includes amounts paid both as a consultant and as an officer of the
Company.
(8) Mr.
Cain
was employed by Arbios Systems, Inc. as a consultant from January 2005 to March
2005 and subsequently was appointed an executive officer in April
2005.
(9) Represents
compensation paid to Mr. Cain for the period from January 2005 to March
2005.
(10) Represents
company matching contributions in the Arbios 401(k) Plan.
Stock
Option Grants
The
following table contains information concerning grants of stock options during
the fiscal year ended December 31, 2005 by us to the Named Executive Officers.
We have not granted any stock appreciation rights.
Option
Grants in Fiscal Year Ended December 31, 2005
|
|
|
|
Individual
Grants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name
|
|
Number
of
Securities
Underlying
Options
Grant
|
|
%
of Total
Options
Granted
to
Employees
In
Fiscal
Year
|
|
Exercise
or
Base
Price
|
|
Expiration
Date
|
|
Walter
C. Ogier
|
|
|
500,000(1)
|
|
|
57%
|
|
$
|
1.85
|
|
|
November
8, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amy
Factor
|
|
|
97,000(2)
|
|
|
34%
|
|
$
|
1.65
|
|
|
April
1, 2010
|
|
|
|
|
103,000(2)
|
|
|
|
|
$
|
1.65
|
|
|
April
1, 2010
|
|
|
|
|
25,000(2)
|
|
|
|
|
$
|
1.85
|
|
|
November
8, 2010
|
|
|
|
|
75,000(2)
|
|
|
|
|
$
|
2.90
|
|
|
March
1, 2010
|
|
|
|
|
200,000(3)
|
|
|
|
|
$
|
2.90
|
|
|
February
1, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jacek
Rozga, M.D., Ph.D.
|
|
|
12,000(4)
|
|
|
2%
|
|
$
|
2.22
|
|
|
July
7, 2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scott
L. Hayashi
|
|
|
12,000(4)
|
|
|
3%
|
|
$
|
2.90
|
|
|
March
1, 2010
|
|
|
|
|
10,000(5)
|
|
|
|
|
$
|
1.85
|
|
|
March
24, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David
J. Zeffren
|
|
|
12,000(4)
|
|
|
1%
|
|
$
|
2.90
|
|
|
March
1, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shawn
P. Cain
|
|
|
30,000(6)
|
|
|
3%
|
|
$
|
1.65
|
|
|
March
31, 2010
|
|
(1)
|
One
half of these options will vest on the one year anniversary of the
date of
grant, and the balance will monthly in monthly increments during
the
second year following the date of
grant.
|
(2)
|
All
of the options were vested upon Ms. Factor’s resignation from the Company
per the terms of her employment
agreement.
|
(3)
|
Represents
a warrant for 200,000 shares of common stock issued to Ms.
Factor.
|
(4)
|
The
options vest in monthly increments over the first twelve months following
the date of grant.
|
(5)
|
One
half of these options vest immediately on the date of grant, and
the
balance vests on the one year anniversary of the date of
grant.
|
(6)
|
The
options vest in monthly increments over the first twenty four months
following the date of grant.
|
Aggregated
Option Exercises in Last Fiscal Year
The
following table sets forth the number and value of unexercised options held
by
the Named Executive Officers as of December 31, 2005. There were no exercises
of
options by the Named Executive Officers in fiscal year 2005.
Aggregated
Option Exercises in Fiscal Year Ended December 31, 2005
and
FY-End Option Values
Name
|
|
Shares
Acquired
on
Exercise
|
|
Value
Realized
|
|
Number
of
Securities
Unexercised
Options
at FY-
End
(#)
Exercisable/
Unexercisable
|
|
Value
of
Unexercised
Options
at FY-
End
(#)
Exercisable/
Unexercisable(1)
|
|
|
|
|
|
|
|
|
|
|
|
Walter
C. Ogier
|
|
|
-
|
|
|
-
|
|
|
0/500,000
|
|
$
|
-
|
|
Amy
Factor
|
|
|
-
|
|
|
-
|
|
|
475,000/0
|
|
$
|
170,000/0
|
|
Jacek
Rozga, M.D., Ph.D.
|
|
|
-
|
|
|
-
|
|
|
71,000/7,000
|
|
$
|
44,100/0
|
|
Scott
L. Hayashi
|
|
|
-
|
|
|
-
|
|
|
27,000/5,000
|
|
$
|
-
|
|
David
J. Zeffren
|
|
|
-
|
|
|
-
|
|
|
20,000/2,000
|
|
$
|
-
|
|
Shawn
P. Cain
|
|
|
-
|
|
|
-
|
|
|
11,250/18,750
|
|
$
|
1,688/2,813
|
|
(1) Dollar
amounts reflect the net values of outstanding stock options computed as the
difference between $1.80 (the last reported sale on December 30, 2005) and
the
exercise price of the options.
Compensation
of Board of Directors
On
March
24, 2005, the Board of Directors approved a plan for compensating the company’s
directors. On May 16, 2005, the Board amended the plan for the 2005 fiscal
year
and later renewed the plan on January 11, 2006 for FY 2006. The plan consists
of
the following:
Non-employee
Directors will receive annual grants of stock options to purchase 15,000 shares
of the company’s common stock. The options will be granted on January 1 of each
year. The options will have a term of seven years and will have an exercise
price equal to the market price on the trading day preceding the grant date.
The
options will vest in equal monthly installments over the 12-month period
following the grant date.
Upon
election to the Board of Directors, each new Director will be granted a stock
option to purchase 30,000 shares of the company’s common stock. The option will
have a term of seven years and will have an exercise price equal to the market
price on the trading day preceding the date of grant. One half of the options
will vest on the date of grant, and the balance will vest on the first
anniversary of the grant date.
On
January 1 of each year, committee members will receive an annual grant of a
stock option to purchase 5,000 shares of common stock for each committee for
which they are a member. The option will have a term of seven years and will
have an exercise price equal to the market price on the trading day preceding
the grant date. The option will vest in equal monthly installments over the
12-month period following the grant date.
Cash
Compensation
Effective
March 24, 2005, all non-employee directors will receive a cash payment of $1,500
for each day they attend a Board of Directors meeting in person ($1,000 if
they
attend a meeting by telephone), and $500 for each telephonic Board meeting
($1,000 for each telephonic meeting if the meeting lasts longer than two hours).
In addition, the Chairman of the Board and Chairman of the Audit Committee
will
each be paid $25,000 annually (payable quarterly), and the Chairman of the
Nomination Committee and the Chairman of the Compensation Committee will each
be
paid $10,000 annually (payable quarterly). The company will also reimburse
all
directors for any expenses incurred by them in attending meetings of the Board
of Directors.
During
the fiscal year ended December 31, 2005, each of our directors was granted
an
annual grant of stock options to purchase 15,000 shares of common stock at
an
exercise price of $2.48 per share. All director options are granted at the
market price on the date of grant and have a term of seven years and vest on
a
monthly basis from the date of grant.
Employment
Contracts and Termination of Employment, and Change-In-Control
Arrangements
We
entered into an agreement with David Zeffren, dated December 30, 2004, pursuant
to which Mr. Zeffren has served as Vice President of Operations. The agreement
provides for a salary of $120,000 per year that is subject to annual review
and
adjustment. The agreement provides that Mr. Zeffren’s employment is “at will”
and can be terminated at any time. Mr. Zeffren’s title and responsibilities were
changed in March 2005 to Vice President Product Development.
We
have
entered into an agreement with Scott Hayashi, dated March 29, 2005, pursuant
to
which Mr. Hayashi serves as Chief Financial Officer. The agreement provides
for
a salary of $105,000 per year that is subject to annual review and adjustment.
Mr. Hayashi is eligible to receive an annual discretionary bonus of up to 15%
of
his salary based on achieving certain goals. The agreement also offered Mr.
Hayashi a five-year qualified stock option to purchase 10,000 shares of our
common stock. The shares are exercisable at $1.85 per share; 50% of the shares
vested immediately and 50% of the shares vest one year from the grant date
of
the option. The agreement provides that Mr. Hayashi’s employment is “at will”
and can be terminated at any time.
We
have
entered into an agreement with Shawn Cain, dated March 22, 2005, pursuant to
which Mr. Cain serves as Vice-President of Operations. The agreement provides
for a salary of $160,000 per year. The agreement also offered Mr. Cain a
five-year incentive stock option to purchase 30,000 shares of our common stock.
The options have an exercise price of $1.65 per share and vest in monthly
installments of 1,250 shares commencing on May 1, 2005. The agreement also
provides that we will match Mr. Cain’s contributions to a 401(k) plan at a rate
of 50% up to 6% of total compensation per year. The agreement also offers to
pay
Mr. Cain’s COBRA costs for an 18-month period commencing on the April 15, 2005.
Mr. Cain is also eligible to receive an annual discretionary cash bonus of
up to
15% of his base annual salary. The agreement provides that Mr. Cain’s employment
is “at will” and can be terminated at any time. During Mr. Cain’s first year of
employment, he will receive six months’ notice if we wish to terminate his
employment, during the second year he will receive four months’ notice and
during the third year he will receive three months’ notice. If we fail to
provide the required notice, upon termination, we will pay Mr. Cain the salary
equivalent of the notice of the shortened notice period.
We
have
entered into an agreement with Dr. Jacek Rozga, dated July 28, 2005, pursuant
to
which Dr. Rozga has served as President and Chief Scientific Officer. The
agreement provides for a salary of $200,000 per year that is subject to review
and adjustment by the Board of Directors. Dr. Rozga is eligible to receive
a
discretionary annual bonus of up to 20% of his salary as determined by the
Board
of Directors. The agreement provides that Dr. Rozga’s employment is “at will”
and can be terminated at any time. Dr. Rozga’s title of President was
transferred to Walter Ogier upon his hiring in November 2005. Dr. Rozga
continues to serve as Chief Scientific Officer.
On
March
31, 2005, we entered into an employment agreement with Amy Factor pursuant
to
which Ms. Factor was appointed as our interim Chief Executive Officer. Under
the
agreement, Ms. Factor was hired to be our Chief Executive Officer until the
hiring of a permanent Chief Executive Officer. The employment agreement was
terminable by either Ms. Factor or by us at any time upon 30 day’s prior written
notice. Under the agreement, we agreed to pay Ms. Factor a base salary at a
monthly rate of $25,000 (which is equivalent to $300,000 on an annualized basis)
and to issue to Ms. Factor five-year non-qualified stock options to purchase
an
aggregate of 200,000 shares of common stock. The options are exercisable at
$1.65 per share (the closing market price of the common stock on March 31,
2005). Options to purchase 80,000 shares vested on March 31, 2005, and the
options for the remaining 120,000 shares will vest in monthly installments
of
6,000 shares commencing on April 1, 2005. The vesting of these options was
to be
accelerated to be immediately and fully vested when we hire a permanent Chief
Executive Officer, which has subsequently occurred. If Ms. Factor terminated
the
employment agreement for any reason other than our breach, or if we terminate
the agreement “for cause” (as defined in the agreement) before all of the
remaining 120,000 options have vested, all unvested options would have been
forfeited. If we had terminated the employment agreement for any reason other
than cause, the options would thereupon immediately and fully (100%) vest.
In
November 2005, Ms. Factor resigned her position as the interim Chief Executive
Officer upon the hiring of Walter C. Ogier, and we terminated her employment
agreement with the Company at such time.
We
entered into an agreement with Walter C. Ogier, dated October 17, 2005, pursuant
to which Mr. Ogier will serve as Chief Executive Officer commencing November
7,
2005. The agreement provides for an annual initial base salary of $300,000
that
is subject to review and adjustment on an annual basis in accordance with the
procedures established by the Board of Directors. Mr. Ogier is eligible to
receive a discretionary annual cash bonus equal to up to 50% of his annual
base
salary. The agreement provides that upon commencement of employment, Mr. Ogier
received an option to purchase 500,000 shares of our common stock, which will
vest 250,000 shares on the one year anniversary of the date Mr. Ogier’s
employment commences and 250,000 shares will vest ratably at the end of each
of
the twelve months of the second year of his employment. If there is a
liquidation or change-in-control of the Company and in connection with such
transaction Mr. Ogier is terminated other than for cause or is no longer
President and Chief Executive Officer of the surviving corporation, then all
options shares granted to Mr. Ogier in connection with his employment will
immediately and fully vest. Additionally, if Mr. Ogier terminates his employment
for good reason or is terminated in anticipation of such a transaction, then
all
option shares granted to Mr. Ogier in connection with his employment will
immediately and fully vest. The agreement provides that Mr. Ogier’s employment
is “at will” and can be terminated at any time. Mr. Ogier is entitled to 12
months of salary if the Company terminates him without cause or he terminates
his employment for defined good reason.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The
following table sets forth certain information regarding beneficial ownership
of
our common stock as of March 6, 2006 (a) by each person known by us to own
beneficially 5% or more of any class of our common stock, (b) by each of our
Named Executive Officers and our directors and (c) by all executive officers
and
directors of this company as a group. As of March 6, 2006 there were 17,460,181
shares of our common stock issued and outstanding. Unless otherwise noted,
we
believe that all persons named in the table have sole voting and investment
power with respect to all the shares beneficially owned by them. Except as
otherwise indicated, the address of each stockholder is c/o the company at
8797
Beverly Blvd., Suite 304, Los Angeles, California, 90048.
Name
and Address of Beneficial Owner
|
|
Shares
Beneficially
Owned
(1)
|
|
Percentage
of
Class
|
|
|
|
|
|
|
|
|
|
Jacek
Rozga, M.D., Ph.D.
|
|
|
2,319,000(2)
|
|
|
13.2
|
%
|
|
|
|
|
|
|
|
|
Achilles
A. Demetriou, M.D., Ph.D
and
Kristin P. Demetriou
|
|
|
2,500,000(3)
|
|
|
14.3
|
%
|
|
|
|
|
|
|
|
|
John
M. Vierling, M.D.
|
|
|
147,667(4)
|
|
|
*
|
|
|
|
|
|
|
|
|
|
Walter
C. Ogier
|
|
|
-0-
|
|
|
*
|
|
|
|
|
|
|
|
|
|
Roy
Eddleman
|
|
|
444,919(5)
|
|
|
2.5
|
%
|
|
|
|
|
|
|
|
|
Marvin
S. Hausman, M.D.
|
|
|
655,750(6)
|
|
|
3.7
|
%
|
|
|
|
|
|
|
|
|
Jack
E. Stover
|
|
|
61,667(7)
|
|
|
*
|
|
|
|
|
|
|
|
|
|
Amy
Factor
|
|
|
925,000(8)
|
|
|
5.1
|
%
|
|
|
|
|
|
|
|
|
Thomas
C. Seoh
|
|
|
36,440(7)
|
|
|
*
|
|
|
|
|
|
|
|
|
|
Dennis
Kogod
|
|
|
28,334(7)
|
|
|
*
|
|
|
|
|
|
|
|
|
|
Thomas
Tully
|
|
|
38,750(7)
|
|
|
*
|
|
|
|
|
|
|
|
|
|
Richard
W. Bank, M.D.
|
|
|
308,851(9)
|
|
|
1.7
|
%
|
|
|
|
|
|
|
|
|
Scott
L. Hayashi
|
|
|
27,000(7)
|
|
|
*
|
|
|
|
|
|
|
|
|
|
David
J. Zeffren
|
|
|
72,000(10)
|
|
|
*
|
|
|
|
|
|
|
|
|
|
Shawn
P. Cain
|
|
|
11,250(7)
|
|
|
*
|
|
|
|
|
|
|
|
|
|
Gary
Ballen
140
Burlingame,
Los
Angeles, California 90049
|
|
|
1,139,222(11)
|
|
|
6.3
|
%
|
|
|
|
|
|
|
|
|
LibertyView
Funds, LP
111
River Street - Suite 1000
Hoboken,
NJ 07030-5776
|
|
|
1,521,892(12)
|
|
|
8.5
|
%
|
|
|
|
|
|
|
|
|
LibertyView
Special Opportunities Fund, LP
111
River Street -- Suite 1000
Hoboken,
NJ 07030-5776
|
|
|
2,339,444(13)
|
|
|
12.9
|
%
|
|
|
|
|
|
|
|
|
Neuberger
Berman LLC
111
River Street - Suite 1000
Hoboken,
NJ 07030-5776
|
|
|
4,384,388(14)
|
|
|
23.5
|
%
|
|
|
|
|
|
|
|
|
All
executive officers and directors as a group (14 persons)
|
|
|
5,076,628(15)
|
|
|
26.2
|
%
|
* Less
than
1%.
(1) |
Beneficial ownership is
determined
in accordance with the rules of the Securities and Exchange Commission
and
generally includes voting or investment power with respect to securities.
Shares of common stock subject to options, warrants and convertible
securities currently exercisable or convertible, or exercisable or
convertible within 60 days, are deemed outstanding, including for purposes
of computing the percentage ownership of the person holding such option,
warrant or convertible security, but not for purposes of computing
the
percentage of any other holder. |
|
|
(2) |
Includes currently exercisable
options to purchase 74,000 shares of common stock. |
|
|
(3) |
Consists of 2,500,000 shares owned by
the A
& K Demetriou Family Trust, of which Achilles A. Demetriou, M.D.,
Ph.D. and Kristin P. Demetriou each are co-trustees with the right
to vote
or dispose of the trust’s shares. |
|
|
(4) |
Consists of currently exercisable options
to
purchase 147,667 shares of common stock. |
|
|
(5) |
Consists of currently exercisable options
to
purchase 82,250 shares of common stock and 362,669 shares of common
stock
owned by Spectrum Laboratories, Inc. Mr. Eddleman is the Chairman of
the
Board and Chief Executive Officer of Spectrum Laboratories,
Inc. |
|
|
(6) |
Consists of (i) currently exercisable
options
to purchase 124,250 shares of common stock, (ii) currently exercisable
warrants to purchase 187,500 shares of common stock, (iii) 100,000
shares
owned by the Marvin Hausman Revocable Trust, and (iv) 244,000 shares
owned
by Northwest Medical Research, Inc. Dr. Hausman is the trustee of the
Marvin Hausman Revocable Trust and the Chief Executive Officer and
principal stockholder of Northwest Medical Research,
Inc. |
|
|
(7) |
Consists of currently exercisable
options. |
|
|
(8) |
Consists
of (i) currently exercisable options to purchase 510,000 shares of
common
stock, (ii) warrants to purchase 200,000 shares exercisable by AFO
Advisors, LLC, (iii) warrants to purchase 100,000 shares exercisable
by
AFO Capital Advisors, LLC, (iv) 5,000 shares owned by the Jay H. Oyer
and
Amy Factor Foundation, (v) 5,000 shares owned by the Melissa H. Oyer
Trust, (vi) 5,000 shares owned by the Zachary D. Oyer Trust, and (vii)
100,000 shares owned by AFO Capital Advisors, LLC. Amy Factor is the
owner
and President of AFO Capital Advisors, LLC and AFO Advisors, LLC. She
is
also the trustee of The Jay H. Oyer and Amy Factor Family Foundation,
The
Melissa H. Oyer Trust, and The Zachary D. Oyer Trust and has voting
and
investment control of the securities of these entities. |
|
|
(9) |
Consists
of (i) currently exercisable options to purchase 115,00 shares of common
stock, (ii) a warrant to purchase 40,000 shares of common stock
exercisable by Richard W. Bank, M.D. (iii) 40,000 shares of common
stock
owned by Richard W. Bank. M.D., (iv) 13,851 shares of common stock
held by
LibertyView Health Sciences Fund, LP, and (iv) a warrant to purchase
100,000 shares of common stock exercisable by LibertyView Health Sciences
Fund, LP. As of March 6, 2006, Dr. Bank was the Senior Portfolio Manager,
Managing Director and Senior Vice President of LibertyView Capital
Management, a division of Neuberger Berman, LLC, which is affiliated
with
the General Partner of the LibertyView Health Sciences Fund, LP. He
left
that position on March 31, 2006. |
|
|
(10) |
Consists
of (i) 25,000 shares owned by Mira Zeffren, David Zeffren’s wife, (ii)
warrants to purchase 25,000 shares registered in the name of Mira Zeffren,
and (iii) currently exercisable options held by David Zeffren for the
purchase of 22,000 shares of common stock. |
|
|
(11) |
Consists
of (i) 417,000 shares of common stock registered in Mr. Ballen’s name,
(ii) currently exercisable warrants to purchase 600,000 shares of common
stock owned by Mr. Ballen, and (iii) 122,222 shares registered in the
name
of American Charter & Marketing LLC, over which Mr. Ballen has voting
and investment control. |
|
|
(12) |
Consists
of (i) 1,100,619 shares of common stock and (ii) currently exercisable
warrants to purchase 421,273 shares of common stock. LibertyView
Funds,
LP, LibertyView Special Opportunities Fund, LP and Trust D for a
Portion
of the Assets of the Kodak Retirement Income Plan have a common investment
advisor, Neuberger Berman, LLC, that has voting and dispositive power
over
the shares held by them, which is exercised by Richard A. Meckler.
Since
they have hired a common investment advisor, these entities are likely
to
vote together. Additionally, there may be common investors within
the
different accounts managed by the same investment advisor. The General
Partner of LibertyView Special Opportunities Fund, LP and LibertyView
Funds, LP is Neuberger Berman Asset Management, LLC, which is affiliated
with Neuberger Berman, LLC, a registered broker-dealer. LibertyView
Capital Management, a division of Neuberger Berman, LLC, is affiliated
with the General Partner of the LibertyView Health Sciences Fund,
LP. The
shares were purchased for investment in the ordinary course of business
and at the time of purchase, there were no agreements or understandings,
directly or indirectly, with any person to distribute the shares.
Trust D
for a Portion of the Assets of the Kodak Retirement Income Plan is
not in
any way affiliated with a broker-dealer.
|
|
|
(13) |
Consists
of (i) 1,724,169 shares of common stock and (ii) currently exercisable
warrants to purchase 615,275 shares of common stock. LibertyView Special
Opportunities Fund, LP, LibertyView Funds, LP and Trust D for a Portion
of
the Assets of the Kodak Retirement Income Plan have a common investment
advisor, Neuberger Berman, LLC, that has voting and dispositive power
over
the shares held by them, which is exercised by Richard A. Meckler.
Since
they have hired a common investment advisor, these entities are likely
to
vote together. Additionally, there may be common investors within the
different accounts managed by the same investment advisor. The General
Partner of LibertyView Special Opportunities Fund, LP and LibertyView
Funds, LP is Neuberger Berman Asset Management, LLC, which is affiliated
with Neuberger Berman, LLC, a registered broker-dealer. LibertyView
Capital Management, a division of Neuberger Berman, LLC, is affiliated
with the General Partner of the LibertyView Health Sciences Fund, LP.
The
shares were purchased for investment in the ordinary course of business
and at the time of purchase, there were no agreements or understandings,
directly or indirectly, with any person to distribute the shares. Trust
D
for a Portion of the Assets of the Kodak Retirement Income Plan is
not in
any way affiliated with a broker-dealer. |
|
|
(14) |
Includes
shares of common stock and currently exercisable warrants to purchase
shares of common stock held by Liberty Funds, LP and LibertyView Special
Opportunities Fund, LP (see footnotes 12 and 13). Also includes (i)
386,689 shares of common stock held by Trust D for a Portion of the
Assets
of the Kodak Retirement Income Fund and (ii) currently exercisable
warrants to purchase 136,363 shares of common stock held by Trust D
for a
Portion of the Assets of the Kodak Retirement Income Plan. LibertyView
Funds, LP, LibertyView Special Opportunities Fund, LP and Trust D for
a
Portion of the Assets of the Kodak Retirement Income Plan have a common
investment advisor, Neuberger Berman, LLC, that has voting and dispositive
power over the shares held by them, which is exercised by Richard A.
Meckler. Since they have hired a common investment advisor, these entities
are likely to vote together. Additionally, there may be common investors
within the different accounts managed by the same investment advisor.
The
General Partner of LibertyView Special Opportunities Fund, LP and
LibertyView Funds, LP is Neuberger Berman Asset Management, LLC, which
is
affiliated with Neuberger Berman, LLC, a registered broker-dealer.
LibertyView Capital Management, a division of Neuberger Berman, LLC,
is
affiliated with the General Partner of the LibertyView Health Sciences
Fund, LP. The shares were purchased for investment in the ordinary
course
of business and at the time of purchase, there were no agreements or
understandings, directly or indirectly, with any person to distribute
the
shares. Trust D for a Portion of the Assets of the Kodak Retirement
Income
Plan is not in any way affiliated with a broker-dealer. |
|
|
(15) |
Includes
currently exercisable options and warrants to purchase 1,931,108 shares
of
common stock. |
SELLING
STOCKHOLDERS
Selling
Stockholder Table
The
shares to be offered by the selling stockholders are "restricted" securities
under applicable federal and state securities laws and are being registered
under the Securities Act of 1933, as amended (the “Securities Act”), to give the
selling stockholders the opportunity to publicly sell or otherwise dispose
of
those shares. The registration of these shares does not require that any of
the
shares be offered or sold by the selling stockholders. The shares included
in
this prospectus may be disposed of by the selling stockholders or their
transferees on any stock exchange, market, or trading facility on which the
shares are traded or in private transactions. These dispositions may be at
fixed
prices, at prevailing market prices at the time of sale, at prices related
to
the prevailing market price, at varying prices determined at the time of sale,
or at negotiated prices. We will not control or determine the price at which
a
selling stockholder decides to dispose of its shares.
No
estimate can be given as to the amount or percentage of our common stock that
will be held by the selling stockholders after any sales or other dispositions
made pursuant to this prospectus because the selling stockholders are not
required to sell any of the shares being registered under this prospectus.
The
following table assumes that the selling stockholders will sell all of the
shares listed in this prospectus.
The
following table sets forth the beneficial ownership of the selling
stockholders:
|
|
Beneficial
Ownership
Before
Offering(1)
|
|
|
|
Beneficial
Ownership
After
Offering(1)
|
|
Selling
stockbroker
|
|
Number
of
Shares
|
|
Percent
|
|
Number
of
Shares
Being
Offered
|
|
Number
of
Shares
|
|
Percent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bristol
Investment Fund, Ltd.(2)
|
|
|
400,773(3)
|
|
|
2.3%
|
|
|
340,909
|
|
|
59,864
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liberty
View Funds, LP(4)
|
|
|
1,521,892(5)
|
|
|
8.5%
|
|
|
545,454
|
|
|
976,438
|
|
|
5.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liberty
View Special
Opportunities
Fund, LP(6)
|
|
|
2,339,444(7)
|
|
|
12.9%
|
|
|
409,090
|
|
|
1,930,354
|
|
|
10.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trust
D for a Portion of the Assets
of
the Kodak Retirement Income
Plan(8)
|
|
|
523,052(9)
|
|
|
3.0%
|
|
|
409,090
|
|
|
113,962
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anna
Zalk
|
|
|
136,363(10)
|
|
|
*
|
|
|
136,363
|
|
|
|
|
|
*
|
|
*Less
than 1%
(1) |
Beneficial
ownership is determined in accordance with the rules of the Securities
and
Exchange Commission and generally includes voting or investment power
with
respect to securities. Shares of common stock subject to options,
warrants
and convertible securities currently exercisable or convertible,
or
exercisable or convertible within 60 days, are deemed outstanding,
including for purposes of computing the percentage ownership of the
person
holding the option, warrant or convertible security, but not for
purposes
of computing the percentage of any other holder. |
|
|
(2) |
Paul
Kessler, manager of Bristol Capital Advisors LLC, the investment
advisor
to Bristol Investment Fund, Ltd., has voting and investment control
of the
securities held by Bristol Investment Fund, Ltd. Paul Kessler disclaims
beneficial ownership of these securities. |
|
|
(3) |
Includes
currently exercisable warrants to purchase 173,500 shares of common
stock. |
|
|
(4) |
Neuberger Berman Asset
Management,
LLC is the general partner of LibertyView Funds, LP. Neuberger Berman
LLC
is the investment adviser to LibertyView Funds, LP and is responsible
for
the selection, acquisition and disposition of the portfolio securities
by
this fund. LibertyView Funds, LP is an affiliate of a registered
broker-dealer. We have been informed by LibertyView Funds, LP that
it
acquired the securities offered by this prospectus for its own account
in
the ordinary course of business, and that, at the time it acquired
such
securities, it had no agreement or understanding, direct or indirect,
with
any person to distribute such securities. |
|
|
(5) |
Includes currently exercisable
warrants to purchase 421,273 shares of common stock. |
|
|
(6) |
Neuberger Berman Asset
Management,
LLC is the general partner of LibertyView Special Opportunities Fund,
LP.
Neuberger Berman LLC is the investment adviser to LibertyView Special
Opportunities Fund, LP and is responsible for the selection, acquisition
and disposition of the portfolio securities by this fund. LibertyView
Special Opportunities Fund, LP is an affiliate of a registered
broker-dealer. We have been informed by LibertyView Special Opportunities
Fund, LP that it acquired the securities offered by this prospectus
for
its own account in the ordinary course of business, and that, at
the time
it acquired such securities, it had no agreement or understanding,
direct
or indirect, with any person to distribute such
securities. |
|
|
(7) |
Includes currently exercisable
warrants to purchase 615,275 shares of common stock. |
|
|
(8) |
Boston Safe Deposit and
Trust
Company and Mellon Bank (DE) N.A. are the co-trustees of Trust D
for a
Portion of the Assets of the Kodak Retirement Income Plan (“Trust D”).
Neuberger Berman, LLC is the investment manager of Trust D and is
responsible for the selection, acquisition and disposition of the
portfolio securities by Trust D pursuant to an investment management
agreement. Trust D is not affiliated with a broker-dealer. Neuberger
Berman, LLC, is a registered broker-dealer. We have been informed
by Trust
D that it acquired the securities offered by this prospectus for
its own
account in the ordinary course of business, and that, at the time
it
acquired such securities, it had no agreement or understanding, direct
or
indirect, with any person to distribute such securities. |
|
|
(9) |
Includes currently exercisable
warrants to purchase 136,363 shares of common stock. |
|
|
(10) |
Includes currently exercisable
warrants to purchase 45,454 shares of common
stock. |
Relationships
with Selling Stockholders
All
of
the selling stockholders are investors who purchased their securities from
us in
the $1,350,000 private placement that was completed on March 6, 2006. Except
as
set forth below, none of the selling stockholders has held any position or
office with us or any of our affiliates, or has had any other material
relationship (other than as purchasers of securities) with us or any of our
affiliates, within the past three years.
The
information in the above table is as of the date of this prospectus. Information
concerning the selling stockholders may change from time to time and any such
changed information will be described if and when necessary in supplements
to
this prospectus or, if appropriate, a post-effective amendment to the
registration statement of which this prospectus is a part.
PLAN
OF DISTRIBUTION
The
selling stockholders, which as used herein includes donees, pledgees,
transferees or other successors-in-interest selling shares of common stock
or
interests in shares of common stock received after the date of this prospectus
from a selling stockholder as a gift, pledge, partnership distribution or other
transfer, may, from time to time, sell, transfer or otherwise dispose of any
or
all of their shares of common stock or interests in shares of common stock
on
any stock exchange, market or trading facility on which the shares are traded
or
in private transactions. These dispositions may be at fixed prices, at
prevailing market prices at the time of sale, at prices related to the
prevailing market price, at varying prices determined at the time of sale,
or at
negotiated prices.
The
selling stockholders may use any one or more of the following methods when
disposing of shares or interests therein:
-
ordinary brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
-
block
trades in which the broker-dealer will attempt to sell the shares as agent,
but
may position and resell a portion of the block as principal to facilitate the
transaction;
-
purchases by a broker-dealer as principal and resale by the broker-dealer for
its account;
-
an
exchange distribution in accordance with the rules of the applicable
exchange;
-
privately negotiated transactions;
-
short
sales effected after the date the registration statement of which this
prospectus is a part is declared effective by the SEC;
-
through
the writing or settlement of options or other hedging transactions, whether
through an options exchange or otherwise;
-
broker-dealers may agree with the selling stockholders to sell a specified
number of such shares at a stipulated price per share;
-
a
combination of any such methods of sale; and
-
any
other method permitted pursuant to applicable law.
The
selling stockholders may, from time to time, pledge or grant a security interest
in some or all of the shares of common stock owned by them and, if they default
in the performance of their secured obligations, the pledgees or secured parties
may offer and sell the shares of common stock, from time to time, under this
prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or
other applicable provision of the Securities Act amending the list of selling
stockholders to include the pledgee, transferee or other successors in interest
as selling stockholders under this prospectus. The selling stockholders also
may
transfer the shares of common stock in other circumstances, in which case the
transferees, pledgees or other successors in interest will be the selling
beneficial owners for purposes of this prospectus.
In
connection with the sale of our common stock or interests therein, the selling
stockholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of the common
stock in the course of hedging the positions they assume. The selling
stockholders may also sell shares of our common stock short and deliver these
securities to close out their short positions, or loan or pledge the common
stock to broker-dealers that in turn may sell these securities. The selling
stockholders may also enter into option or other transactions with
broker-dealers or other financial institutions or the creation of one or more
derivative securities which require the delivery to such broker-dealer or other
financial institution of shares offered by this prospectus, which shares such
broker-dealer or other financial institution may resell pursuant to this
prospectus (as supplemented or amended to reflect such
transaction).
The
aggregate proceeds to the selling stockholders from the sale of the common
stock
offered by them will be the purchase price of the common stock less discounts
or
commissions, if any. Each of the selling stockholders reserves the right to
accept and, together with their agents from time to time, to reject, in whole
or
in part, any proposed purchase of common stock to be made directly or through
agents. We will not receive any of the proceeds from this offering. Upon any
exercise of the warrants by payment of cash, however, we will receive the
exercise price of the warrants.
The
selling stockholders also may resell all or a portion of the shares in open
market transactions in reliance upon Rule 144 under the Securities Act of 1933,
provided that they meet the criteria and conform to the requirements of that
rule.
The
selling stockholders and any underwriters, broker-dealers or agents that
participate in the sale of the common stock or interests therein may be
"underwriters" within the meaning of Section 2(11) of the Securities Act. Any
discounts, commissions, concessions or profit they earn on any resale of the
shares may be underwriting discounts and commissions under the Securities Act.
Selling stockholders who are "underwriters" within the meaning of Section 2(11)
of the Securities Act will be subject to the prospectus delivery requirements
of
the Securities Act.
To
the
extent required, the shares of our common stock to be sold, the names of the
selling stockholders, the respective purchase prices and public offering prices,
the names of any agents, dealer or underwriter, any applicable commissions
or
discounts with respect to a particular offer will be set forth in an
accompanying prospectus supplement or, if appropriate, a post-effective
amendment to the registration statement that includes this
prospectus.
In
order
to comply with the securities laws of some states, if applicable, the common
stock may be sold in these jurisdictions only through registered or licensed
brokers or dealers. In addition, in some states the common stock may not be
sold
unless it has been registered or qualified for sale or an exemption from
registration or qualification requirements is available and is complied
with.
We
have
advised the selling stockholders that the anti-manipulation rules of Regulation
M under the Exchange Act may apply to sales of shares in the market and to
the
activities of the selling stockholders and their affiliates. In addition, we
will make copies of this prospectus (as it may be supplemented or amended from
time to time) available to the selling stockholders for the purpose of
satisfying the prospectus delivery requirements of the Securities Act. The
selling stockholders may indemnify any broker-dealer that participates in
transactions involving the sale of the shares against certain liabilities,
including liabilities arising under the Securities Act.
We
have
agreed to indemnify the selling stockholders against liabilities, including
liabilities under the Securities Act and state securities laws, relating to
the
registration of the shares offered by this prospectus.
We
have
agreed with the selling stockholders to keep the registration statement of
which
this prospectus constitutes a part effective until the earlier of (1) such
time
as all of the shares covered by this prospectus have been disposed of pursuant
to and in accordance with the registration statement or (2) the date on which
the shares may be sold pursuant to Rule 144(k) of the Securities
Act.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
On
December 26, 2001, Arbios entered into various agreements with Spectrum
Laboratories, Inc. Concurrently with these agreements, Spectrum Laboratories
also purchased 362,669 shares of our common stock. Mr. Eddleman, one of the
members of our Board of Directors, is the Chairman and Chief Executive Officer
of Spectrum Laboratories. The three principal agreements entered into by Arbios
and Spectrum Laboratories in December 2001 are the following:
A. License
Agreement.
Spectrum
Laboratories granted to Arbios an exclusive, worldwide license to develop,
make,
use and distribute products based on two Spectrum Laboratories patents. Provided
that Arbios purchases the hollow fiber cartridges that it expects that it will
need for its products from Spectrum Laboratories, Arbios will not have to pay
a
royalty for the license. In the event that Spectrum Labs is not the manufacturer
of the hollow fiber cartridges, Arbios will have to pay Spectrum Labs a royalty
for the license (see, “Business--Manufacturing and Supply Agreement”). Spectrum
Labs also agreed to grant Arbios a right of first refusal to obtain a license
to
make, use, develop or distribute products based on Spectrum Labs’ technology
other than in liver assisted products, provided that such other products are
in
the fields of artificial blood therapy and bioprocessing and therapeutic
devices.
B. Research
Agreement.
Arbios
and Spectrum Laboratories also entered into a four-year research agreement
pursuant to which Arbios and Spectrum Laboratories agreed to combine their
expertise and their respective technologies to enable Arbios to (i) develop
liver assist systems, (ii) conduct pre-clinical and Phase I-III clinical
testing, (iii) obtain regulatory approvals and (iv) commercialize such liver
assist systems. Under the terms of the agreement, Spectrum Laboratories agreed
to perform certain research toward the development of hollow fiber-in-fiber
modules for Arbios’ liver assist systems during product development,
pre-clinical and clinical testing at no cost to Arbios. Spectrum Laboratories
also agreed to pay for all costs and expenses in connection with the research
program and agreed to allocate a total of $550,000 to the program during the
research term. In October 2002, Arbios and Spectrum Laboratories agreed that
Spectrum Laboratories has now satisfied its research and development
obligations, that ATI owed Spectrum Laboratories an additional $54,960 for
services provided by Spectrum Laboratories (which amount was paid in full in
2004), and that the 362,669 shares of Arbios common stock previously issued
to
Spectrum Laboratories are now fully vested. Spectrum Laboratories has agreed
to
perform additional research and development work as may be requested by Arbios
on such terms as the parties may agree to in good faith
negotiations.
C. Manufacturing
and Supply Agreement.
Arbios
and Spectrum Laboratories have also entered into an agreement pursuant to which
the parties have agreed that Spectrum Laboratories will manufacture for Arbios
the hollow fiber cartridges with fiber-in-fiber geometry for its LIVERAID™
device. The agreement provides that the price of the hollow fiber-in-fiber
cartridges to be sold by Spectrum Laboratories to Arbios will be determined
by
good faith negotiations between the parties. Arbios has agreed that it will
not
purchase cartridges with fiber-in-fiber geometry from any other manufacturer
unless Spectrum Laboratories is either unable or unwilling to manufacture the
cartridges. In the event that Spectrum Laboratories is unwilling to manufacture
the fiber-in-fiber cartridges for Arbios, Arbios shall have the right to have
a
third party manufacture the cartridges for it, in which case Arbios will pay
Spectrum Laboratories a royalty for the license granted to Arbios by Spectrum
Laboratories under the License Agreement. The royalty shall be equal to 3%
of
the net sales (total sales less taxes, returns, transportation, insurance,
and
handling charges) attributed solely to the fiber-in-fiber
cartridges.
Agreement
with Marvin Hausman, M.D.
On
October 17, 2005, we entered into a Consulting Agreement with Marvin S. Hausman,
M.D. Dr. Hausman is a member of our Board of Directors. Under the Consulting
Agreement, Dr. Hausman agreed to provide us with consulting services in support
of our SEPET clinical trial program. We agreed to pay Dr. Hausman a $10,000
monthly retainer for a period of three months for his consulting services and
granted a five-year non-qualified stock option to purchase 30,000 shares of
our
common stock under our 2005 Stock Incentive Plan, of which 25,000 shares were
ultimately awarded to him based on certain terms of the Consulting Agreement.
The exercise price of the foregoing options is $1.80 per share and vest on
a
monthly basis for a period of one year beginning January 1, 2006.
Agreement
with AFO Advisors, LLC
Pursuant
to a verbal arrangement with AFO Advisors, LLC, we engaged Amy Factor to provide
investor relations services to support our fundraising efforts as well as
provide strategic and financial advice. Ms. Factor is a member of our Board
of
Directors and is the President of AFO Advisors, LLC. Under the arrangement,
we
agreed to pay Ms. Factor a $7,500 monthly retainer for a period of three months
commencing January 1, 2006 to March 31, 2006 and granted a five year
non-qualified stock option to purchase 30,000 shares of our common stock under
our 2005 Stock Incentive Plan. The exercise price of the foregoing options
is
$1.80 per share and vest on a monthly basis during for a period of three months
beginning January 1, 2006. We have verbally extended the arrangement to provide
Ms. Factor with $7,500 per month for investor relations services for an
indefinite period.
Warrant
to Adam Hausman
On
February 17, 2004, we issued 7,500 shares of common stock and a warrant to
purchase 7,500 shares of common stock to Adam Hausman, who is the son of Marvin
S. Hausman, M.D., a member of our Board of Directors, as compensation for
finder’s fees related to the October 2003 financing. The warrant has a
three-year life and is exercisable at $2.50 per share.
DESCRIPTION
OF SECURITIES
We
are
presently authorized to issue 60,000,000 shares of $0.001 par value common
stock
and 5,000,000 shares of $0.001 par value preferred stock. As of the date of
this
prospectus, we had 17,460,181 shares of common stock issued and outstanding
and
no preferred stock issued and outstanding.
Common
Stock
The
holders of our common stock are entitled to equal dividends and distributions
per share with respect to the common stock when, as and if declared by the
board
of directors from funds legally available therefore. No holder of any shares
of
common stock has a preemptive right to subscribe for any of our securities,
nor
are any common shares subject to redemption or convertible into other
securities. Upon liquidation, dissolution or winding-up of our company, and
after payment of creditors and preferred stockholders, if any, the assets will
be divided pro rata on a share-for-share basis among the holders of the shares
of common stock. All shares of common stock now outstanding are fully paid,
validly issued and non-assessable. Each share of our common stock is entitled
to
one vote with respect to the election of any director or any other matter upon
which stockholders are required or permitted to vote. We have not paid any
dividends on our common stock to date and do not anticipate that we will be
paying dividends in the foreseeable future. Any payment of cash dividends on
our
common stock in the future will be dependent upon the amount of funds legally
available, our earnings, if any, our financial condition, our anticipated
capital requirements and other factors that the Board of Directors may think
are
relevant. However, we currently intend for the foreseeable future to follow
a
policy of retaining all of our earnings, if any, to finance the development
and
expansion of our business and, therefore, do not expect to pay any dividends
on
our common stock in the foreseeable future.
Preferred
Stock
Under
our
articles of incorporation, the board of directors has the power, without further
action by the holders of the common stock, to designate the relative rights
and
preferences of the preferred stock, and to issue the preferred stock in one
or
more series as designated by the board of directors. The designation of rights
and preferences could include preferences as to liquidation, redemption and
conversion rights, voting rights, dividends or other preferences, any of which
may be dilutive of the interest of the holders of the common stock or the
preferred stock of any other series. The issuance of preferred stock may have
the effect of delaying or preventing a change in control of the company without
further stockholder action and may adversely affect the rights and powers,
including voting rights, of the holders of the common stock.
Registration
Rights
In
connection with the organization and initial capitalization of ATI, we granted
certain “piggy-back” registration rights to The A & K Demetriou Family
Trust, Jacek Rozga, and Cedars-Sinai Medical Center, our initial three
stockholders. Under these agreements, subject to certain customary conditions
and exceptions, the foregoing three stockholders have the right to include
in
any future registration statement filed by this company some or all of their
shares of the common stock. The shares of common stock owned by Cedars-Sinai
Medical Center have been included in a prior, currently effective, registration
statement. Accordingly, unless that prior registration statement is withdrawn
before Cedars-Sinai sells its shares under that registration statement, we
will
have no further obligation to register the shares of Cedars-Sinai. The A & K
Demetriou Family Trust and Jacek Rozga have waived their rights to have their
shares included in this prospectus.
On
March
6, 2006, we announced that we have signed binding agreements and closed a
private placement financing of Units, consisting of common stock and warrants,
for gross proceeds of $1.35 million. Each Unit consists of one share of our
common stock and one warrant to purchase 0.50 of a share of our common stock,
comprising a total of 1,227,272 shares of our common stock and warrants to
purchase 613,634 shares of our common stock. The offering was made to accredited
investors, as defined in applicable SEC regulations. Under the terms of the
purchase agreement, the Units were sold at a price of $1.10 per Unit, and the
warrants will be exercisable for a period of five years at a price of $1.50
per
share. Under the terms of the registration rights agreement, we agreed to file
a
registration statement with the SEC for the resale of the shares of common
stock
and the shares of common stock underlying the warrants sold in the private
placement within 60 days of the March 6, 2006 closing.
This
prospectus includes 1,840,906 shares that we are obligated to register under
the
foregoing registration rights agreement. In
the
event that the resale registration statement has not been declared effective
within certain time periods or if sales cannot be made pursuant to the
registration statement following its effectiveness, each as described in the
registration rights agreement, the we will be obligated to pay to each investor
liquidated damages, subject to certain limitations set forth in the registration
rights agreement.
Delaware
Law and Certain Charter and By-law Provisions
The
provisions of Delaware law and of our Certificate of Incorporation and By-laws
discussed below could discourage or make it more difficult to accomplish a
proxy
contest or other change in our management or the acquisition of control by
a
holder of a substantial amount of our voting stock. It is possible that these
provisions could make it more difficult to accomplish, or could deter,
transactions that stockholders may otherwise consider to be in their best
interests or our best interests.
Business
Combinations.
We are
subject to the provisions of Section 203 of the General Corporation Law of
the
State of Delaware. 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 is approved
in
a prescribed manner. A “business combination” includes mergers, asset sales and
other transactions resulting in a financial benefit to the interested
stockholder. Subject to specified exceptions, an “interested stockholder” is a
person who, together with affiliates and associates, owns, or within three
years
did own, 15% or more of the corporation’s voting stock.
Limitation
of Liability; Indemnification.
Our
charter contains provisions permitted under the General Corporation Law of
the
State of Delaware relating to the liability of directors. The provisions
eliminate a director’s liability for monetary damages for a breach of fiduciary
duty as a director, except in circumstances involving wrongful acts, such as
the
breach of a director’s duty of loyalty or acts or omissions which involve
intentional misconduct or a knowing violation of law. The limitation of
liability described above does not alter the liability of our directors and
officers under federal securities laws. Furthermore, our charter and by-laws
contain provisions to indemnify our directors and officers to the fullest extent
permitted by the General Corporation Law of the State of Delaware. These
provisions do not limit or eliminate our right or the right of any stockholder
of ours to seek non-monetary relief, such as an injunction or rescission in
the
event of a breach by a director or an officer of his duty of care to us. We
believe that these provisions will assist us in attracting and retaining
qualified individuals to serve as directors.
Special
Meeting of Stockholders.
Our
By-laws provide that special meetings of our stockholders may be called only
by
our chairman of the board, chief executive officer or by our board of
directors.
Preferred
Stock Issuances.
Our
Certificate of Incorporation provides that, without stockholder approval, we
can
issue up to 5,000,000 shares of preferred stock with rights and preferences
determined by our board of directors.
Shares
Eligible for Future Sale
As
of the
date of this prospectus, we had 17,460,181 shares of common stock outstanding.
That number does not include (i) the 2,115,000 shares that are reserved for
issuance under outstanding options and that may be issued if and when the
options are exercised, or (ii) 8,165,477 shares that may be issued upon the
exercise of currently outstanding warrants (including the warrants to purchase
613,634 shares that are owned by the selling stockholders listed in this
prospectus).
Freely
Tradeable Shares After Offering.
As of
the date of this prospectus, excluding the shares that are covered by this
prospectus, 11,487,909 shares of our 17,460,181 currently outstanding shares
can
be publicly resold. Upon the re-sale of the 1,227,272 currently outstanding
shares covered by this prospectus, and the exercise and sale of the 613,634
warrant shares included in this prospectus, all of these 1,840,906 shares will
also be freely tradable without restriction or limitation under the Securities
Act. As a result, after the completion of this offering, there will be a total
of 13,328,815 shares of our common stock that will be tradable without
restriction under the Securities Act. In addition, we have also previously
registered 7,107,810 additional shares of our common stock that can be issued
upon the exercise of outstanding warrants and can also be immediately resold
pursuant to those prior registration statements.
Rule
144.
In
general, under Rule 144 as currently in effect, a person (or persons whose
shares are aggregated) who has beneficially owned restricted securities for
at
least one year, including persons who may be deemed our “affiliates,” as that
term is defined under the Securities Act, would be entitled to sell within
any
three month period a number of shares that does not exceed the greater of 1%
of
the then outstanding shares (approximately 174,602 shares if the currently
outstanding warrants and options are not exercised, or 277,407 shares if all
outstanding options and warrants are exercised) or the average weekly trading
volume of shares during the four calendar weeks preceding such sale. Sales
under
Rule 144 are subject to certain manner-of-sale provisions, notice requirements
and the availability of current public information about the company. A person
who has not been our affiliate at any time during the three months preceding
a
sale, and who has beneficially owned his shares for at least two years, would
be
entitled under Rule 144(k) to sell such shares without regard to any volume
limitations under Rule 144. Subject
to certain volume limitations and other conditions, all of the currently
outstanding unregistered shares are eligible for public resale under Rule 144.
The availability of Rule 144 to our holders of restricted securities is,
however, conditioned on various factors, including the availability of certain
public information concerning the Company.
Form
S-8 Registration of Options.
We have
registered on Form S-8 all of the 1,000,000 shares of our common stock that
are
eligible for sale under options granted under our 2001 Stock Option Plan. In
addition, we have also registered on Form S-8 all 3,000,000 shares of common
stock that have been reserved for issuance under our 2005 Stock Incentive Plan,
which would permit the resale of such shares in the public
marketplace.
Transfer
Agent
Our
transfer agent currently is The Nevada Agency and Trust Company, 50 West Liberty
Street, Suite 880, Reno, Nevada 89501.
INTERESTS
OF NAMED EXPERTS AND COUNSEL
No
expert
or counsel was hired on a contingent basis that will receive a direct or
indirect interest in our business that is valued at greater than
$50,000.
The
financial statements for the years ended December 31, 2005 and 2004 included
in
this prospectus have been audited by Stonefield Josephson, Inc. to the extent
and for the periods indicated in their report thereon. Such financial statements
have been included in this prospectus and registration statement in reliance
upon the report of Stonefield Josephson, Inc. and upon the authority of such
firm as experts in auditing and accounting.
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION
FOR
SECURITIES ACT LIABILITIES
Our
Certificate of Incorporation provides that, to the fullest extent permitted
by
Section 145 of the Delaware General Corporation Law, we have the power to
indemnify, and our By-laws state that we shall indemnify and hold harmless,
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 our
right) by reason of the fact that he is or was a director, officer, employee
or
agent of this corporation or is or was serving at our request as a director,
officer, employee or agent of another corporation or enterprise, against
expenses (including attorneys’ fees), judgments, fines and amounts paid in
settlement actually and reasonably incurred by such person in connection with
such action, suit or proceeding if such person 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 such person’s conduct was unlawful. Our By-laws also provide that
expenses incurred by an officer or director in defending a suit shall be paid
by
us in advance of such proceeding’s final disposition upon receipt of an
undertaking by or on behalf of the director or officer to repay such amount
if
it shall ultimately be determined that he or she is not entitled to be
indemnified by us.
Our
Certificate of Incorporation also provides that no director shall be personally
liable to us or to our stockholders for monetary damages for breach of his
fiduciary duty as a director. Delaware law does not permit the elimination
of
liability (i) for any breach of the director’s duty of loyalty to us or our
stockholders, (ii) for acts or omissions not in good faith or which involve
intentional misconduct or a knowing violation of law, (iii) in respect of
certain unlawful dividend payments or stock redemptions or repurchases or (iv)
for any transaction from which the director derives an improper personal
benefit. The effect of this provision in the Certificate of Incorporation is
to
eliminate the rights of this corporation and its stockholders (through
stockholders’ derivative suits on behalf of this corporation) to recover
monetary damages against a director for breach of fiduciary duty as a director
thereof (including breaches resulting from negligent or grossly negligent
behavior) except in the situations described in clauses (i)-(iv), inclusive,
above.
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to directors, officers and controlling persons of the small business
issuer pursuant to the foregoing provisions, or otherwise, the small business
issuer has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the
Act
and is, therefore, unenforceable.
LEGAL
MATTERS
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Boston, Massachusetts,
will
provide us with an opinion as to the legal matters in connection with the
securities we are offering.
WHERE
YOU CAN FIND MORE INFORMATION
We
have
filed with the Securities and Exchange Commission a registration statement
on
Form SB-2 under the Securities Act for the common stock offered under this
prospectus. We are subject to the informational requirements of the Exchange
Act, and file annual reports, quarterly reports, special reports, proxy
statements and other information with the Commission. These reports, proxy
statements and other information filed by Arbios Systems, Inc. can be inspected
and copied at the public reference facilities of the Commission at Station
Place, 100 F Street, N.E., Washington, D.C. 20549. Copies of these materials
can
be obtained from the Public Reference Section of the Commission at Station
Place, 100 F Street, N.E., Washington, D.C. 20549, at prescribed rates. The
Commission also maintains a Web site that contains reports, proxy statements,
information statements and other information concerning Arbios Systems, Inc.
at
the site located at http://www.sec.gov.
This
prospectus does not contain all the information in the registration statement
and its exhibits, which we have filed with the Commission under the Securities
Act and to which reference is made.
INDEX
TO FINANCIAL STATEMENTS
Independent
Registered Public Accounting Firm Report
|
|
|
F-1
|
|
Balance
Sheet - As of December 31, 2005 and 2004
|
|
|
F-2
|
|
Statement
of Operations - For the Years Ended December 31, 2005, 2004
and
Period From August 23, 2000 (Inception) to December 30,
2005
|
|
|
F-3
|
|
Statement
of Cash Flows - For the Years Ended December 31, 2005, 2004
and
Period From August 23, 2000 (Inception) to December 30,
2005
|
|
|
F-4
|
|
Statements
of Change in Stockholders’ Equity - For the Years Ended
December 31,
2005, 2004 and Period From August 23, 2000 (Inception) to December
30,
2005
|
|
|
F-5
|
|
Notes
to Financial Statements
|
|
|
F-9
|
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board
of
Directors
Arbios
Systems, Inc.
Los
Angeles, California
We
have
audited the accompanying balance sheets of Arbios Systems, Inc. as of December
31, 2005 and 2004 and the related statements of operations, stockholders’ equity
and cash flows for the years then ended, and from August 23, 2000 (inception)
to
December 31, 2005. These financial statements are the responsibility of
the
Company's management. Our responsibility is to express an opinion on these
financial statements based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan and perform the audit to obtain reasonable assurance about whether
the
financial statements are free of material misstatement. We were not
engaged to perform an audit of the Company's internal control over financial
reporting. Our audit included consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing
an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the finacial statements, assessing the accounting principles
used
and significant estimates made by mangement, as well as evaluating the
overall
statement presentation. We believe that our audit provides a reasonable
basis for our opinion.
In
our
opinion, the financial statements referred to above present fairly, in
all
material respects, the financial position of Arbios Systems, Inc. as of
December
31, 2005 and 2004 and the results of its operations and cash flows for
the years
ended December 31, 2005 and 2004, and from August 23, 2000 (inception)
to
December 31, 2005, in conformity with accounting principles generally accepted
in the United States of America.
Certified
Public Accountants
Los
Angeles, California
March
2,
2006
ARBIOS
SYSTEMS, INC.
|
|
(A
development stage company)
|
|
BALANCE
SHEETS
|
|
December
31, 2005 and 2004
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
ASSETS
|
|
2005
|
|
2004
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
2,379,738
|
|
$
|
1,501,905
|
|
Short
term investments
|
|
$
|
1,996,000
|
|
|
|
|
Prepaid
expenses
|
|
|
195,841
|
|
|
97,653
|
|
Total
current assets
|
|
$
|
4,571,579
|
|
$
|
1,599,558
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
101,629
|
|
|
107,789
|
|
Patent
rights, net of accumulated amortization of $93,418
for 2005 & $105,457
for 2004
|
|
|
173,249
|
|
|
294,543
|
|
Other
assets
|
|
|
55,773
|
|
|
33,164
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
4,902,230
|
|
$
|
2,035,054
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
160,649
|
|
$
|
92,304
|
|
Accrued
expenses
|
|
|
152,362
|
|
|
121,460
|
|
Contract
commitment
|
|
|
|
|
|
250,000
|
|
Current
portion of capitalized lease obligation
|
|
|
|
|
|
5,341
|
|
Total
current liabilities
|
|
|
313,011
|
|
|
469,105
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
Preferred
stock, $.001 par value; 5,000,000 shares authorized: none
issued and outstanding
|
|
|
|
|
|
|
|
Common
stock, $.001 par value; 60,000,000 and 25,000,000 shares authorized
as
of 2005 and 2004; 16,232,909 and 13,216,097 shares issued and outstanding
in 2005 and 2004, respectively
|
|
|
16,233
|
|
|
13,216
|
|
Additional
paid-in capital
|
|
|
13,352,217
|
|
|
6,508,061
|
|
Deficit
accumulated during the development stage
|
|
|
(8,779,231
|
)
|
|
(4,955,328
|
)
|
Total
stockholders' equity
|
|
|
4,589,219
|
|
|
1,565,949
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
|
$
|
4,902,230
|
|
$
|
2,035,054
|
|
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of these financial
statements.
ARBIOS
SYSTEMS, INC.
|
(A
development stage company)
|
STATEMENTS
OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
For
the years ended December 31,
|
|
Inception,
Aug.
23, 2000 to
|
|
|
|
2005
|
|
2004
|
|
Dec.
31, 2005
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
-
|
|
$
|
72,030
|
|
$
|
320,966
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
2,394,546
|
|
|
1,988,763
|
|
|
5,006,915
|
|
Research
and development
|
|
|
1,554,509
|
|
|
1,426,379
|
|
|
3,990,562
|
|
Total
operating expenses
|
|
|
3,949,055
|
|
|
3,415,142
|
|
|
8,997,477
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before other income (expense)
|
|
|
(3,949,055
|
)
|
|
(3,343,112
|
)
|
|
(8,676,511
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
125,286
|
|
|
16,132
|
|
|
141,418
|
|
Interest
expense
|
|
|
(134
|
)
|
|
(847
|
)
|
|
(244,138
|
)
|
Total
other income (expense)
|
|
|
125,152
|
|
|
15,285
|
|
|
(102,720
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(3,823,903
|
)
|
$
|
(3,327,827
|
)
|
$
|
(8,779,231
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
earnings per share:
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$
|
(0.24
|
)
|
$
|
(0.25
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares:
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
|
16,137,676
|
|
|
13,199,325
|
|
|
|
|
The
accompanying notes are an integral part of these
financial statements.
ARBIOS
SYSTEMS, INC.
|
(A
development stage company)
|
STATEMENTS
OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For
the years ended December 31,
|
|
|
|
|
|
2005
|
|
2004
|
|
Inception to December 31, 2005
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(3,823,903
|
)
|
$
|
(3,327,827
|
)
|
$
|
(8,779,231
|
)
|
Adjustments
to reconcile net loss to net cash
|
|
|
|
|
|
|
|
|
|
|
used
in operating activities:
|
|
|
|
|
|
|
|
|
|
|
Amortization
of debt discount
|
|
|
|
|
|
|
|
|
244,795
|
|
Depreciation
and amortization
|
|
|
59,249
|
|
|
48,191
|
|
|
199,777
|
|
Patent
rights impairment
|
|
|
91,694
|
|
|
|
|
|
91,694
|
|
Issuance
of common stock and warrants for compensation
|
|
|
557,079
|
|
|
1,045,552
|
|
|
1,613,131
|
|
Interest
earned on discounted short term investments
|
|
|
(8,652
|
)
|
|
|
|
|
(8,652
|
)
|
Settlement
of accrued expenses
|
|
|
|
|
|
|
|
|
54,401
|
|
Deferred
compensation costs
|
|
|
|
|
|
|
|
|
319,553
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
(98,188
|
)
|
|
58,333
|
|
|
(195,843
|
)
|
Other
assets
|
|
|
(22,609
|
)
|
|
(25,730
|
)
|
|
(55,773
|
)
|
Accounts
payable and accrued expenses
|
|
|
34,552
|
|
|
36,727
|
|
|
219,509
|
|
Other
liabilities
|
|
|
64,695
|
|
|
(5,556
|
)
|
|
64,695
|
|
Contract
obligation
|
|
|
(250,000
|
)
|
|
250,000
|
|
|
-
|
|
Net
cash used in operating activities
|
|
|
(3,396,083
|
)
|
|
(1,920,310
|
)
|
|
(6,231,944
|
)
|
Cash
flows used in investing activities:
|
|
|
|
|
|
|
|
|
|
|
Additions
of property and equipment
|
|
|
(23,489
|
)
|
|
(80,745
|
)
|
|
(141,349
|
)
|
Purchase
of short term investments
|
|
|
(8,977,714
|
)
|
|
|
|
|
(8,977,714
|
)
|
Maturities
of short term investments
|
|
|
6,990,366
|
|
|
|
|
|
6,990,366
|
|
Net
cash used in investing activities
|
|
|
(2,010,837
|
)
|
|
(80,745
|
)
|
|
(2,128,697
|
)
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of convertible debt
|
|
|
|
|
|
|
|
|
400,000
|
|
Proceeds
from common stock option exercise
|
|
|
62,500
|
|
|
2,700
|
|
|
65,200
|
|
Proceeds
from issuance of common stock, net of costs
|
|
|
6,227,594
|
|
|
|
|
|
10,058,262
|
|
Proceeds
from issuance of preferred stock, net of costs
|
|
|
|
|
|
|
|
|
|