UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
x ANNUAL REPORT
UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the
fiscal year ended December 31, 2008
o TRANSITION REPORT
UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the
transition period from _________ to _________
Commission
File Number: 000-32603
ARBIOS
SYSTEMS, INC.
(Name of
small business issuer in its charter)
Delaware
(State
or other jurisdiction of
incorporation
or organization)
|
91-1955323
(I.R.S. Employer
Identification
No.)
|
200
E. Del Mar Blvd., Suite 320
Pasadena,
CA
(Address
of principal executive offices)
|
91105
(Zip
Code)
|
Registrant’s
telephone number, including area code: 626-356-3105
Securities
registered pursuant to Section 12(b) of the
Act: None
Securities
registered pursuant to Section 12(g) of the Act: Common
Stock, $.001 par value (Title of class)
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. o Yes x
No
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or 15(d) of the Exchange Act. o Yes x No
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or
for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90
days. x Yes o No
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of the registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. x
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act (Check one):
Large accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act): o Yes x No
The
aggregate market value of the common stock held by non-affiliates of the
registrant as of March 31, 2009 was approximately $578,000.
There
were 24,356,247 shares of the registrant’s common stock outstanding on March 31,
2009.
Documents
incorporated by reference: None
TABLE
OF CONTENTS
Part
I
|
1.
|
Description
of
Business
|
2
|
1.A
|
Risk
Factors
|
17
|
1.B
|
Unresolved
Staff
Comments
|
25
|
2
|
Description
of
Property
|
26
|
3.
|
Legal
Proceedings
|
26
|
4.
|
Submission
of Matters to a Vote of Security Holders
|
26
|
|
Part
II
|
5.
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
26
|
6.
|
Selected
Financial
Data
|
27
|
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
27
|
7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
32
|
8.
|
Financial
Statements and Supplementary Data
|
32
|
9.
|
Changes
In and Disagreements With Accountants on Accounting and Financial
Disclosure
|
32
|
9A(T).
|
Controls
and Procedures
|
32
|
9B.
|
Other
Information
|
34
|
|
Part
III
|
10.
|
Directors,
Executive Officers and Corporate Governance
|
34
|
11.
|
Executive
Compensation
|
37
|
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
44
|
13.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
47
|
14.
|
Principal
Accountant Fees and Services
|
47
|
15.
|
Exhibits
and Financial Statement Schedules
|
48
|
Introductory
Comment
Throughout
this Annual Report on Form 10-K, the terms “we,” “us,” “our,” “the
Company,” “Arbios” and “our company” refer to Arbios Systems, Inc., a Delaware
corporation. A glossary of certain terms used in this Annual Report
is contained on page 16 below.
Forward
Looking Statements
The
Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for
forward-looking statements. This annual report contains
forward-looking statements within the meaning of the federal securities
laws. These include statements about our expectations, beliefs,
intentions or strategies for the future, which we indicate by words or phrases
such as “anticipate,” “expect,” “intend,” “plan,” “will,” “we believe,” “the
company believes,” “management believes” and similar language. The
forward-looking statements are based on our current management’s expectations
and are subject to certain risks, uncertainties and assumptions, including in
particular those regarding the outcome of our pending bankruptcy proceedings and
the plans of the officers and directors who will control this company if and
when we emerge from bankruptcy. If our plan of reorganization is
approved, all of our current officers and directors will be replaced, and our
company’s future operations will be management by new officers and directors
whose forward-looking statements are not contained in this Annual
Report. Accordingly, future activities and business results of this
company may differ materially from those anticipated in the forward-looking
statements made herein. We base our forward-looking statements on
information currently available to us, and we assume no obligation to update
them. 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” and
“Management’s Discussion and Analysis of Financial Condition and Results of
Operations.”
Summary
Overview of our Company
Arbios
Systems, Inc. is a Delaware corporation with its corporate office in Pasadena,
California. To date, our goal was to seek to develop, manufacture and
market liver assist therapies to meet the urgent need for medical treatment of
liver failure.
Since
Arbios Systems, Inc. was incorporated in February 1999, we have been a medical
device and cell-therapy company that was focused on the development of products
for the treatment of liver failure. Our lead product candidate which was under
development during 2008 consisted of a novel extracorporeal blood purification
therapy called the SEPET™ Liver Assist Device. Until recently, we
also owned the rights to an extracorporeal, bioartificial liver therapy referred
to as the HepatAssist™ Cell-Based Liver Support System which incorporates
porcine pig liver cells which we sold in October 2008. Because of our
limited financial resources, all of our development activities during the past
few years have focused on our SEPET™ Liver Assist Device. In
September 2007, we announced the results of our 15-patient feasibility clinical
study of our SEPET™ Liver Assist Device, targeted for the treatment of acute
episodes of chronic liver disease, in which 79% of the 14 treated patients met
the primary clinical effectiveness endpoint. Based on the results of
the feasibility study, in February 2008, the U.S. Food and Drug Administration
(“FDA”) granted us conditional approval of an Investigational Device Exemption,
or IDE, application to begin the pivotal clinical trial for
SEPET™. In May 2008, we received approval to being the first segment
of our pivotal clinical trial for SEPETTM. The
budget to complete this clinical trial and our other projected operating
expenses, however, far exceeded the limited financial resources available to us
at that time.
As a
development stage company engaged solely in the development of new products, we
did not generate revenues from our activities and, accordingly, we were solely
dependent upon our ability to raise funding from investors to finance both our
operating expenses and the cost of developing our technologies. Due
in part to the global economic crisis in 2008 and the dramatic decline in the
availability of financing, particularly to development stage companies, we were
unable to raise the capital we needed to finance our operational and
developmental activities. As a result, in order to preserve our
remaining cash while seeking financing and while attempting to otherwise
maximize the value of our assets, in mid-2008 we terminated all of our employees
and suspended the majority of our operations. Since then, all of our
activities have been conducted by our interim Chief Executive Officer and our
interim Chief Financial Officer, both of whom we engaged as part-time
consultants. We have not conducted any active operations since
mid-2008, and our sole activity since that time has been to (i) seek sufficient
capital to re-initiate our operations, (ii) find a strategic partner to
co-develop our technologies with us, or (iii) sell our technologies and assets
in a manner that will maximize shareholder value. Consistent with
this plan, in October 2008, we sold the HepatAssistTM
Cell-Based Liver Support System to HepaLife Technologies, Inc. (“HepaLife”) for
(a) $450,000 in cash, of which $250,000 was paid in October 2008 and the
remaining $200,000 was deferred for up to 18 months from the date of sale, and
(b) a warrant to purchase 750,000 shares of HepaLife common stock at an exercise
price of $0.35 per share. On April 1, 2009, HepaLife and
the Company entered into an agreement to pay us the $200,000 deferred payment
now, in return for the cancellation of the 750,000 warrant shares to purchase
HepaLife common stock that was part of the consideration in our sale of
HepatAssistTM to
HepaLife. This proposed transaction is scheduled for a hearing on
April 20, 2009 before the Bankruptcy Court, which must approve any such
transaction (see below).
Our
executive office is located at 200 E. Del Mar Blvd., Suite 320, Pasadena, CA
91105, and our telephone number at this office is 626-356-3105. We
also maintain a web site at www.arbios.com. The information on our
web site is not, and you should not consider such information to be, a part of
this filing.
Voluntary
Chapter 11 Filing
On
January 9, 2009, the company filed a voluntary petition for relief under Chapter
11 of the United States Bankruptcy Code (the “Bankruptcy Code”) with the United
States Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”),
Case Number 09-10082 (the “Bankruptcy”). We are continuing to operate
as a debtor-in-possession under the jurisdiction of the Bankruptcy Court and in
accordance with the applicable provisions of the Bankruptcy Code and the orders
of the Bankruptcy Court. In general, as a debtor-in-possession, our
current management supervises our activities as authorized under the Bankruptcy
Code, but may not engage in transactions outside the ordinary course of business
without the prior approval of the Bankruptcy Court.
Pending
$1,000,000 Investment and Recapitalization
One of
the principal reasons for commencing the Bankruptcy was to permit the orderly
sale of our remaining assets and technologies under court protection and/or to
recapitalize our company. Consistent with our goals, on March 9, 2009
we entered into binding term sheet (the “Term Sheet”) with Arbios Acquisition
Partners, LLC (“Acquisition Partners”), an unrelated, privately held, limited
liability company formed for the purpose of effecting the transaction
contemplated by the Term Sheet. Pursuant to the Term Sheet, subject
to the approval of the Bankruptcy Court, we agreed that we would (i) cancel all
of our currently existing equity (including, but not limited to, any and all
outstanding common and preferred shares of stock, warrants, and options), (ii)
issue new shares of its common stock to Acquisition Partners representing 90% of
our newly issued shares, and (iii) issue to our existing shareholders new shares
of our common stock equal to 10% of our newly issued shares pro
rata. (The effect of the cancellation of the outstanding common stock
and the issuance of the shares constituting 10% of the outstanding shares is the
same as a 1-for-10 reverse stock split.) In consideration for issuing
the new shares to it, Acquisition Partners agreed to pay us $1,000,000 in
cash.
The
$1,000,000 cash purchase price to be paid by Acquisition Partners for 90% of our
new shares of common stock is required to be paid as follows: (1) $100,000 was
paid to us at the time that the Term Sheet was signed, (2) $100,000
is required to be paid to us on April 20, 2009, the date that we currently
anticipate that we will have a Court hearing on our plan of reorganization as a
disclosure statement, and (3) $800,000 is due within 10 days following the
confirmation of the plan of reorganization. If Acquisition Partners
does not pay the final $800,000 by the required payment date, we will retain the
$200,000 that Acquisition Partners has paid so far, and we can then either
withdraw the current plan of reorganization, terminate that plan, and/or enter
into an alternate transaction with other entities interested in acquiring this
company or our assets. If our plan of reorganization to approve the
investment by Acquisition Partners has not been confirmed by June 15, 2009, we
will obligated to return to Acquisition Partners its $200,000 payment, less
costs and expenses, (including, without limitation, administrative expenses)
incurred by us in pursuing the plan of reorganization.
We expect
to consummate the transaction with Acquisition Partners, but we are not
prohibited from effecting a different transaction with other
parties. Accordingly, we have agreed to pay Acquisition Partners a
break up fee of 3% of the funds deposited by Acquisition Partners if we elect
not to consummate the transaction contemplated by the Term Sheet and elect to
enter into an alternative transaction, such as signing a letter of intent or
term sheet with a third party for the sale of some or all of our assets prior to
confirmation of the plan of reorganization. Also, if we exercise our
option to transact business with a third party rather than with Acquisition
Partners, then Acquisition Partners would also be entitled to a return of all
funds that they have paid to us prior to such date. However, we do
not have to return Acquisition Partners’ deposit if we elect to sell our assets
to a third party because Acquisition Partners fails to pay the final $800,000
payment.
The Term
Sheet has not yet been approved by the Bankruptcy Court. A hearing on
the Term Sheet is scheduled for April 20, 2009 before the Bankruptcy
Court. No assurance can be given that the Bankruptcy Court will
approve the Term Sheet and the transactions contemplated thereby.
Plan
of Reorganization; Recapitalization of our Company
On April
3, 2009, we filed a motion to conditionally approve our Chapter 11 plan of
reorganization as the disclosure statement (the motion to conditionally approve
the disclosure statement and the attached plan of reorganization is herein
referred to as the “Plan”). The Bankruptcy Court has not confirmed
the Plan of reorganization or its use as a disclosure statement, and the hearing
on this motion is currently scheduled to be held on April 20,
2009. The Plan may be modified prior to the April 20, 2009 hearing
date.
In
general, if the Plan is confirmed by the Bankruptcy Court, we will consummate
the transactions with Acquisition Partners as described in the Term Sheet, and
our company will thereafter emerge from Bankruptcy as follows:
·
|
Administrative
and Priority Claims will be paid in full and Allowed General Unsecured
Claim Holders will receive 90% of the principal amount of their Allowed
Claim.
|
·
|
90%
of our common stock will be owned by Acquisition Partners, and 10% will be
owned by all of our stockholders who own shares on the date that the Plan
is confirmed. The 10% of our stock that will be issued to our
existing stockholders will be issued pro rata based on the number of
shares each stockholder owned prior to the confirmation. As
part of this transaction, all currently outstanding shares of our common
stock will be cancelled on the date of confirmation, and one new share
will be issued for each ten shares that are
cancelled.
|
·
|
All
currently outstanding options and warrants will be cancelled and will
cease to exist.
|
·
|
We
will receive an infusion of $1,000,000 in the aggregate from Acquisition
Partners, which amount is expected to be used to fund our working capital
needs and possibly for the further development of our liver
technology.
|
·
|
All
of our officers and directors will resign, and new officers and directors
designated by Acquisition Partners will be
appointed. Acquisition Partners has designated the following
persons to hold the following offices with this company after the
Bankruptcy if the Plan is confirmed: Tom Fagan--Director,
Chairman of the Board, CEO and President; Cara Fagan--Director, Secretary
and Treasurer; John Desiderio--Director. Shawn Cain, Arbios’
Interim President and CEO, may continue to provide consulting services to
us and Acquisition Partners after the Plan has been
confirmed.
|
·
|
Arbios
Systems, Inc. will remain a public company whose shares are listed for
trading on the OTC Bulletin Board, or some other trading
platform.
|
·
|
We
have previously in-licensed a family of issued U.S. patents and various
U.S. and foreign patent applications from Immunocept LLC, including five
issued U.S. patents, four pending U.S. patents, and two pending European
patents. On January 2, 2009, Immunocept, LLC declared a default
in the foregoing license with us. We are currently in
discussions with Immunocept regarding the license agreement, and our goal
is to have the License Agreement, as it may be modified prior to April 20,
2009, assumed as part of the Plan. If we do modify the
Immunocept license agreement, those modifications may be reflected as
amendments to the Plan. However, Immunocept and Acquisition
Partners are requesting that we agree to certain modifications to the
license agreement before it can be assumed by us and become part of the
Plan. We have not yet agreed to all terms, and it is not
certain that the Immunocept license agreement will be assumed as part of
the Plan. In the event that the Immunocept license, as it may
be modified, is not in effect after the Bankruptcy, we will have to
reconsider the effect that the lack of that license will have on our
future operations, and we may elect to restructure our post-bankruptcy
business plan.
|
The Term
Sheet provides that the confirmation of the Plan should occur on or before May
15, 2009. No assurance can be given that the Plan will be confirmed
by that date, or at all.
Background
of Our Company; Strategy
Drs. Achilles
A. Demetriou and Jacek Rozga, two leaders in the field of artificial liver
therapy, formed our company to develop extracorporeal therapies for the
treatment of liver failure. Drs. Demetriou and Rozga developed our
SEPET™ device, which is a sterile, disposable cartridge with proprietary
membrane permeability characteristics for use in treating patients with liver
failure. As employees of Cedars-Sinai Medical Center in Los Angeles,
California, Drs. Demetriou and Rozga were also involved in the development of a
first generation bioartificial liver known as HepatAssistTM that
was licensed by Cedars-Sinai Medical Center in 1994 to W.R. Grace & Co. and
then subsequently transferred to Circe Biomedical, Inc. Circe Biomedical ceased
operations in 2003 and in April 2004, we purchased the remaining assets of Circe
Biomedical that related to its bioartificial liver operations, including rights
to the original HepatAssistTM
system. The HepatAssistTM system
is the assets that we recently sold to HepaLife Technologies, Inc on October 3,
2008.
To date,
we have funded our operations from the proceeds from the sale of over
$18,000,000 of our equity securities and $321,000 of Small Business Innovation
Research grants that have been awarded by the U.S. Small Business
Administration. We will, however, have to raise substantial
additional capital to fund our future clinical development expenses and our
on-going working capital needs.
In May
2008, we finalized the primary endpoints for our pivotal trial and received
permission from the FDA to commence the pivotal clinical trial for
SEPET™. We had hoped to use our clinical data to support the
marketing authorization process in the European Union to receive CE Marking for
our SEPETTM Liver
Assist Device. However, due to our lack of cash resources, we have
not been able to commence the pivotal trial, and in July 2008 we terminated all
of our employees and clinical consultants and suspended the majority of our
operations.
Before we
suspended the majority of our operations in July 2008 due to lack of funding,
our strategy and plan was to first complete the clinical testing and obtain
regulatory approval for the SEPET™ Liver Assist Device before proceeding with
our HepatAssistTM
Cell-Based Liver Support System because of the shorter regulatory path and the
ability of SEPET™ to operate through the use of a standard, currently available
kidney dialysis instruments. Therefore, we focused our efforts on the
development of SEPET™. We have already performed in vitro and in vivo testing of the SEPET™
prototype device and commenced clinical testing of SEPET™ in late
2005. We treated 14 patients suffering from acute-on-chronic liver
failure with hepatic encephalopathy in the Phase I feasibility clinical trial of
SEPET™ and have completed this clinical trial. In May 2008, we
received approval to commence a Phase II/III pivotal clinical trial for
SEPETTM. Our
strategy for realizing sales revenue from SEPET™ was to seek a CE Mark in Europe
prior to approval of the product candidate by the FDA. We also
believed that we could commercialize SEPET™ in Asia, although we had not yet
received assurance of regulatory pathways in that
region. Commercialization of SEPET™ in the United States could only
proceed if and when we successfully completed a pivotal clinical trial of
SEPET™, meeting efficacy endpoints approved by the FDA.
Based on
our current assumptions regarding clinical trial sizes and other factors, we
estimate that the future clinical cost of developing SEPET™ to the FDA’s
standards will be approximately $5 million to $10 million. These
amounts, which could vary substantially if our assumptions are not correct and
it turns out that we need to enroll significantly more patients in our trials or
if the FDA mandates that our pivotal trial of SEPET™ include a survival-based
primary endpoint. Our strategy had been to obtain the necessary
funding from investors in 2008. However, we were unable to acquire
the necessary funding in 2008, which resulted in the Bankruptcy.
Finally,
our strategy for manufacturing our SEPET cartridge was to leverage the
manufacturing expertise of third parties. Accordingly, we have
already entered into exclusive manufacturing and supply agreements with Membrana
GmbH and NxStage Medical Inc. Membrana is a Germany company that
specializes in the manufacture of membranes used for
hemofiltration. It has agreed to supply us with the membrane material
needed for manufacture of the SEPETTM Liver
Assist Device. NxStage is a U.S. based company that has agreed to
assemble the SEPETTM
cartridge utilizing the membrane provided by Membrana.
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. We believe that
treatments with currently available technologies such as blood detoxification
methods are short-term measures, and none of them has achieved wide-spread
clinical use or demonstrated ability in randomized, controlled clinical trials
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 prior to transplantation. 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 liver organ regeneration still
present in the blood of these 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. In addition to
demonstrating an extension of survival in large animal model testing of SEPET™,
79% of the patients in our recently completed feasibility clinical trail of
SEPET™ showed full resolution or a reduction in hepatic encephalopathy (H.E.,
also known as liver coma) by at least two grades of H.E.
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 levels of
substances toxic to the brain and liver in the patient’s blood and to provide
whole liver functions, which are impaired or lost.
SEPET™
The
SEPET™ Liver Assist Device
Until we
suspended the majority of our operations in July 2008, we were developing the
SEPET™ Liver Assist Device as a blood purification measure to provide temporary
liver support for acute exacerbation of chronic liver disease. SEPET™
therapy was to 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 filtering a portion of the substances in the
patient’s blood including albumin-bound toxins, inflammatory disease mediators,
and soluble toxins. The importance of using fibers with this sieving
characteristic, which allows for filtration of molecules larger than
conventional renal dialysis cartridges, is that known hepatic failure toxins as
well as mediators of inflammation and inhibitors of hepatic regeneration have
low-to-medium sized molecular weights while “good” blood components generally
have relatively high molecular weight. At present, Membrana supplies
us with the hemofiltration membranes and NxStage assembles the disposable SEPET™
cartridges. See “Manufacturing” below. The SEPET™ system
is designed for use with commercially available kidney dialysis instruments or
other similar machines that utilize disposable hollow-fiber
cartridges. Accordingly, no specialized apparatus needs to be
developed or manufactured for the use of SEPET™. Accessory components
for the SEPET™ system such as disposable tubing sets 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 for use with SEPET™ will be
manufactured for us by qualified third-party vendors.
During
SEPETTM
therapy, a patient’s blood is pumped through the hollow fibers contained in the
cartridge and substances normally metabolized by the liver and accumulated in
the blood during liver failure are transported convectively across the porous
fiber wall and an ultrafiltrate containing toxins, inhibitors of hepatic growth
and mediators of inflammation is removed from the patient’s blood stream by
exiting 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 this two-step blood purification, or detoxification, process, 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.
Clinical
Development
Our
SEPET™ Liver Assist Device has been tested in an IDE clinical feasibility trial
in the United States we completed in 2007. This single arm, uncontrolled study
enrolled 15 patients at three major liver transplant hospitals (Cedars Sinai
Medical Center, Los Angeles; Albert Einstein Medical Center, Philadelphia; and
University of California Medical Center, San Diego) under an IDE application
approved by the FDA in 2005. The study enrolled patients suffering hepatic
encephalopathy (also known as liver coma), ranging from Grade I to Grade
III. Of the 15 patients enrolled into the trial, 14 patients were treated
with at least one (typically 5-6 hour) round of SEPET™ treatment, receiving an
average of less than two, and a maximum of four, sequential daily treatments
until a stable, durable disease response was achieved. Final analysis of
the clinical trial results confirmed a high rate of achievement of the primary
endpoint for clinical effectiveness with 11/14 (79%) subjects showing full
resolution or a reduction in hepatic encephalopathy by at least two
grades. The responses were generally rapid and observed within 48 hours
after initiation of treatment, with many occurring during the first
treatment. Thirteen of 14 (93%) patients’ responses were sustained over
the 30-day follow-up period, and improved overall liver function was documented
as determined by biochemical measures. Just one out of the 14 patients
treated proved refractory to repeated SEPET™ treatment, however, achieving a
single-grade improvement in their encephalopathy. Two additional patients
had treatment halted early, prior to achievement of stable response, due in one
case to mild bleeding at a catheterization site and in the other to malfunction
of a dialysis machine not associated with our SEPET™ liver assist
device. All patients survived until the end of the 30-day follow-up
period and 4 patients were subsequently transplanted with a donor liver.
SEPET™ treatment was generally well-tolerated and had no negative effects on
vital signs (heart rate, blood pressure and respiration) and base blood
chemistries. Expected moderate reductions in blood platelets were
observed, none with critical consequence. An adverse event of renewed,
mild bleeding from a site of prior recent trauma, categorized as severe, was not
associated with a low platelet count and was likely caused by the use of heparin
for anticoagulation, which is commonly utilized in extracorporeal blood
therapy. All treatment-related adverse events were expected and typical of
extracorporeal blood therapy procedures, and all were resolved satisfactorily
with indicated standard treatment. FDA has allowed a SEPET™ protocol
amendment involving discretionary substitution of an alternative anticoagulation
method, utilizing sodium citrate instead of heparin, which is anticipated to
reduce bleeding risk in subsequent treatments.
Based
upon the results of the feasibility study, we submitted an IDE application to
the FDA seeking approval to initiate a pivotal trial of SEPET™. The
design for this trial submitted to the FDA entailed enrolling approximately 100
patients in the principal randomized, controlled phase of the study, targeted to
achieve the primary endpoint of the trial, which is a clinically significant
reduction in hepatic encephalopathy. Patients receiving SEPET™ treatment
plus standard medical care would be compared to control patients receiving
treatment with standard medical care alone, with a 1:1 randomization between the
two groups. An adaptive design feature, increasingly common in FDA product
approval trials, would permit the size of the trial to be increased after
enrollment of the first 100 patients if the primary efficacy endpoint has not
yet reached statistical significance but has shown a positive trend. This
potential extension of the trial would also be permitted to achieve statistical
significance of one or more secondary endpoints of the trial relating to
clinical, functional, and reimbursement advantages for SEPET™-treated
patients. Following a meeting with the FDA in the summer of 2007, the
FDA granted us conditional approval of the IDE application in February 2008 to
begin the pivotal clinical trial while we respond to the FDA’s conditions and
request for additional information. In particular, the FDA had requested a
survival primary endpoint rather than the primary endpoint of a two-stage drop
in hepatic encephalopathy proposed in our original trial design submitted to the
FDA. We have had an additional meeting with the FDA in March 2008 to
discuss our position regarding a suitable primary endpoint for the trial. In May
2008 the FDA granted us approval of the revised IDE to begin the pivotal trial
for SEPETTM.
Benefits
of SEPET™
We
believe that our SEPET™ Liver Assist Device, if approved by the FDA and
commercially released, 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 (act as a “bridge” to liver
regeneration);
|
·
|
support
patients during periods of functional recovery and regeneration after
partial liver 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;
|
·
|
shorten
overall hospital stay; and
|
·
|
reduce
the cost of care.
|
We
believe that our SEPET™ Liver Assist Device can achieve these effects because it
can lower levels of substances that are toxic to both the brain and liver and
other internal organs. We have obtained final results in the
feasibility clinical trial of SEPET™. However, final proof of
clinical benefit in patients is lacking at this time, and the clinical utility
of SEPETTM still
needs to be conclusively demonstrated in patients with liver failure through
randomized, controlled clinical trials of the SEPETTM
therapy.
Advantages
of Our SEPET™ Product Candidate
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 in hospitals and outpatient clinics
and, therefore, there may be a reduced need for extensive personnel
training for use of these similar systems with SEPET™. These
systems are commonly available in intensive care units and related
settings where SEPET™ may be initially used for treating acute episodes of
chronic liver failure.
|
·
|
Reduced
cost. The cost of therapy is expected to be lower than
with other liver assist devices that are 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. However further (e.g. Phase IV) clinical trials will
likely be necessary to fully develop these additional indications for
SEPET™.
|
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 can address patients with liver failure across a wide range of
causes and severity, including acute exacerbation of chronic liver disease as
well as acute liver failure in patients without history of chronic
disease.
The
market for SEPET™ includes the U.S. market, the European market, and the rest of
the world. Because the Immunocept patents only apply in the U.S. and
not in Europe, our ability to commercialize SEPET™ in the U.S. may be affected
by the license granted to us by Immunocept to certain patents if the license
agreement is not assumed under the Plan. Immunocept provided notice
of termination and a default of its license with us on January 2,
2009. Since the commencement of the Bankruptcy, we have been in
negotiations with Immunocept to reinstate the license agreement and to have the
license agreement assumed as part of the Plan. However, we have not
yet reached an agreement with Immunocept. In the event that we are
unable to reach an accommodation with Immunocept, we will not have the right to
use the licensed technologies in the U.S. and would, therefore, have to
re-evaluate the effect that the lack of that license will have on the future
development of SEPET™ in the U.S. If we do not have the right to the
Immunocept license following the Bankruptcy, we may choose to initially limit
our focus on obtaining CE Marking in Europe and commercializing SEPET™ in Europe
or modify our business plan as needed. Thereafter, depending on
our evaluation of the Immunocept licenses and on financial and other
considerations, we may continue to seek to obtain FDA marketing approval for
SEPET™ in the U.S.
We
believe that the patient and market opportunity is substantial and
underserved. According to the American Liver Foundation, 25,000,000
persons in the United States, nearly one in every ten
persons, are or have been suffering from liver and biliary diseases.
According to the National Center for Health Statistics data published for 2004,
there were over 500,000 hospital discharges for patients with chronic liver
disease and/or cirrhosis plus additional patients categorized as suffering from
other forms of liver failure. According to the American Liver
Foundation, liver disease is among the top seven causes of death in adults in
the United States between the ages of 25 to 64. In fact, one out of every 10
Americans has some form of liver disease. There is currently no
satisfactory therapy available to treat patients in liver failure, other than
maintenance and monitoring of vital functions and keeping patients stable
through provision of intravenous fluids and blood products, administration of
antibiotics and support of vital functions, such as respiration.
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 4 million Americans are
chronically infected with the hepatitis C virus, and an estimated 25,000 people
each year are newly infected in the United States each year with the hepatitis C
virus. At the same time, 10,000 to 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 14, 2008, the liver transplant waiting list contained 16,390 individuals.
Hepatitis B is less prevalent in the United States than hepatitis C – a
situation that is dramatically reversed in other parts of the world where
chronic hepatitis B infection is endemic or pandemic; however, according to
National Institutes of Health and the American Association for the Study of
Liver Diseases, 5,000 deaths occur annually in the United States 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 the 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 most
urgent. 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 dependable 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
$10,000 or more per day. While liver transplants have significantly
increased the chances of survival for patients with liver failure, due to a
severe shortage of donor livers, far 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 in
the United States the cost to the provider of a single treatment with the SEPET™
therapy could be within a $2,000 to $4,000 range. Pricing in other
world regions will likely vary. We anticipate that the SEPET™ therapy
may have to be repeated up to an average of three to five 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™ 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 our SEPET™ device, liver
failure patients treated with our product 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
product candidates.
Sales,
Marketing & Distribution
We
currently do not have any agreements in place to market our SEPET™ product
candidate if and when that product is commercially released. Before
we suspended our operations, our plan was to outsource at least a portion of the
sales, marketing and distribution of our products, if approved, including SEPET™
in Europe if we obtain CE Marking approval, to third parties who specialize in
the sales, marketing and distribution of medical
products. Alternatively, we also planned to enter into strategic
alliances with larger medical companies or license the rights to our product
candidates to such larger companies.
Until we
suspended our operations in 2008, we were working on a marketing authorization
process in the European Union to receive CE Marking for our SEPETTM Liver
Assist Device. CE Marking indicates that the product complies with the essential
requirements of the relevant European health, safety and environmental
protection legislation and allows sale of the product within the European Union
(28 countries) and the European Free Trade Association (3
countries).
Manufacturing
& Supply
If we
continue to develop SEPET™ after the Bankruptcy, the cartridges that will be
needed for SEPET™ device are expected to be commercially manufactured by NxStage
Medical, Inc., and the membrane inside the cartridge are expected to be produced
by Membrana GmbH. Additional disposable components, such as tubing connectors,
could also be manufactured by third party subcontractors.
Supply
Agreement with Membrana GmbH
On
September 14, 2007, we entered into a supply agreement with Membrana, a company
organized under the laws of Germany, for the provision of membranes for use in
SEPET™. The agreement provides that following the first commercial
sale of our product that contains Membrana membranes, Membrana will be our
exclusive supplier of certain identified membranes for use in certain of our
products. In addition, the agreement provides that following the
first commercial sale of our product that contains Membrana membranes, Membrana
shall not supply certain identified membranes for use in certain of our products
to any other third party that will incorporate such membranes into a product
whose composition, method of manufacture or method of use falls within a claim
of one of our issued U.S. patents. Such exclusivity may last for up
to five years based upon our fulfillment of certain minimum purchase
thresholds. The agreement also provides for pre-established per-unit
pricing of Membrana membranes, including progressive quantity
discounts.
The
agreement will terminate following the six-year anniversary of the date of the
first commercial sale of our product that contains Membrana
membranes. The agreement may be terminated by either party upon 90
days notice in the event of a material breach by the other party that remains
uncured for 90 days, or upon 60 days notice if the other party becomes insolvent
or becomes the subject of any voluntary or involuntary proceeding in bankruptcy,
liquidation, dissolution, receivership, or general assignment for the benefit of
creditors that is not dismissed within 60 days. In addition, upon 60
days notice, we may terminate the agreement or terminate the exclusivity of the
agreement, upon Membrana’s failure to meet certain delivery
requirements. As of the date of the filing of this report, we have
not received notice from Membrana of its intention to terminate the
agreement.
Manufacturing
& Supply Agreement with NxStage Medical, Inc.
On
October 19, 2007, we entered into a manufacturing & supply agreement with
NxStage Medical, Inc. for the manufacture and supply of our SEPET™ Liver Assist
Device for use in clinical trials and for commercial sale, if it is
approved. The agreement provides that NxStage will be our exclusive
manufacturer and supplier of the SEPET™ Liver Assist Device for commercial sale
until the fifth anniversary of regulatory approval of the
device. Under the agreement, NxStage will not manufacture, supply or
sell our device to other parties and if NxStage manufactures, supplies or sells
a competing product, as defined in the agreement, subject to certain exceptions,
we may terminate the arrangement or convert it into a non-exclusive arrangement.
In addition, if we purchase more than a certain number of devices in one
calendar year, we will be subject to an annual minimum purchase requirement for
the remainder of the agreement, which minimum will be subject to adjustment each
year. The agreement provides for pre-established per-unit pricing,
including quantity discounts and yearly adjustments.
The
agreement will terminate upon the earlier of (i) the seventh anniversary of
regulatory approval of the device or (ii) the seventh anniversary of the date of
the agreement if regulatory approval of the device is not obtained by such
date. The agreement may be terminated by either party (i) upon an
extended prior notice period, (ii) upon a material breach by the other party
that remains uncured, or (iii) upon notice if the other party becomes insolvent,
files for bankruptcy, goes into liquidation or a receiver is appointed over all
or a major part of the other parties’ assets. In addition, we may
terminate the agreement or terminate the exclusivity of the agreement, upon the
occurrence of certain events. As of the date of the filing of this
report, we have not received notice from NxStage of its intention to terminate
the agreement.
Platforms
used for SEPETTM
Device
The
kidney dialysis systems 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 instruments will not be affected, only the kidney
dialysis cartridge will be replaced by a SEPETTM
cartridge, we do not anticipate that consents will have to be obtained from the
manufacturers of those open platform units, and no additional insurance is
expected to be required to use those units. Nevertheless,
manufacturers of such instruments may in the future have incentives to form
partnerships with us for marketing and distribution of disposables, either as
stand-alone products or as integrated systems of disposables for use on their
instruments.
Patents
and Proprietary Rights
Our
intellectual property rights relating to the SEPETTM Liver
Assist Device consist of a U.S. patent application plus pending foreign
counterpart applications, a family of in-licensed U.S. patents plus foreign
counterparts and pending patent applications, and certain related trade
secrets.
Our U.S.
patent application and foreign counterparts regarding our selective plasma
filtration therapy (SEPET™) technology was filed in August 2002 with the U.S.
Patent and Trademark Office and European Patent Office and subsequently in other
countries and is currently under review for possible issuance. The
applications contain claims for the use of various hemofiltration apparatus to
treat liver failure and related diseases, as well as claims covering the
hemofiltration apparatus itself.
In March
2007, we in-licensed a family of five issued U.S. patents and various U.S. and
foreign patent applications from Immunocept, LLC which include broad claims for
methods of treating liver failure, multi-organ failure, multi-organ dysfunction
syndrome, sepsis, septic shock, systemic inflammatory response syndrome, and
related inflammatory disorders by selective blood
filtration. The patents and applications relate to the use of
blood filtration devices which remove, from the blood of patients with the above
disease conditions, a broad spectrum of inflammatory and other disease mediators
ranging from small molecules through intermediate size blood proteins with
molecular weights up to the size of beneficial immunoglobulins. Such
devices are capable of removing known “bad actor” compounds associated with
liver failure, multi-organ failure and sepsis while preserving critical
immunogloblins, clotting factors, lipids, and other beneficial large proteins in
the circulating blood of afflicted patients. The patents and/or
applications also relate to the combined use of replacement fluids including
human serum albumin or combined uses of secondary selective plasma adsorption
devices and/or certain classes of anti-inflammatory therapeutic drugs, and to
apparatus suitable for the above uses. In addition to the
Immunocept related patents acquired in March 2007, we currently have four patent
applications pending related to SEPETTM.
On
January 2, 2009, Immunocept, LLC declared a default in its License Agreement and
informed us that it had terminated the license. We are currently in
discussions with Immunocept to reinstate the license agreement and to have the
license agreement assumed as part of the Plan. If the license
agreement with Immunocept is reinstated, we will owe royalties on net sales of
products which are covered by the license, including potentially the SEPET™
Liver Assist Device, ranging from low- to mid-single digit percentages of net
sales. We will also owe maintenance fees and certain other minimum
spending obligations under the license and may owe contingent milestone
fees. Before Immunocept declared a breach under the license
agreement, (i) our fixed obligations under the license would have totaled less
than $500,000 over the next 4 years, a portion of which includes spending on
future product development possibly leading to future sales revenues for us, and
(ii) our contingent obligations under the license would have totaled less than
$500,000 over approximately the same period (dependent, however, on the pace of
potential future patent issuances). No assurance can be given that we will be
able to assume the Immunocept license and that the patents licensed to us under
that agreement will be available to us after the Bankruptcy.
Research
and Development
We spent
approximately $1,213,000 on research and development during the fiscal year
ended December 31, 2008, $2,300,000 on research and development during the
fiscal year ended December 31, 2007 and $9,326,000 on research and development
from inception (August 23, 2000) through December 31, 2008.
Competition
If
developed and commercially released, our SEPET™ Liver Assist Device will compete
with several 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
product candidates 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 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. 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.
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.
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 IDE (in the case of a medical device such as SEPET™) is filed with
the FDA to begin human testing. Typically, a two-phase (for devices)
or a three-phase (for drugs/biologics) clinical testing program is then
undertaken. In Phase I or feasibility phase, small clinical trials
are conducted to determine the safety of the product candidate. In
Phase II (typically not required for devices), clinical trials are conducted to
assess safety and gain preliminary evidence of the efficacy of the product
candidate. In Phase III or pivotal phase, clinical trials are
conducted to provide sufficient data for the statistically valid proof of safety
and efficacy. Variations on these paths can also occur, and
repetition of particular phases may be required.
The time
and expense required to perform this clinical testing can vary and be very
substantial. No action can be taken to market any new device, drug or
combination 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
usually 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 Practices 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, or PMA,
application requires more extensive pre-filing testing than the 510(k)
Notification procedure and involves a significantly longer FDA review process,
although the process is typically less than for a new drug or combination
product (in part because of the two-phase versus three-phase clinical trial
process described above).
SEPET™
may be regulated in the United States as a Class III medical device requiring a
PMA review process, similar to medical devices for conducting plasma exchange;
however, the FDA may also elect to classify it as a Class II device suitable for
Section 510(k) approval described above. Accordingly, it is likely to
be subject to a two-step approval process starting with a submission of an IDE
and subsequent amendments to conduct human studies, followed by the submission
of a PMA application. The steps required before a product such as
SEPET™ is likely to 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 IDE 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 candidate; and (iv) the submission to the FDA of a product
application. Preclinical tests include laboratory evaluation of the
product candidate, as well as animal studies to assess the potential safety and
efficacy of the product candidate. The results of the preclinical
tests, together with analytical data, are submitted to the FDA as part of an
IDE, 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. As discussed above,
human clinical trials typically involve two sequential phases. Each
trial must be reviewed and approved by the FDA before it can
begin. The feasibility phase involves the initial introduction of the
experimental product into human subjects to evaluate its safety and, if
possible, to gain early indications of efficacy. The pivotal phase
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
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. In Europe, we would need to obtain
approval to market SEPET™ under the CE Mark and related device regulations,
which often require less clinical testing than comparable approval processes in
the United States. Label claims for medical devices marketed under
the CE Mark are restricted to what has been proven in clinical
trials. This can have an adverse impact on marketability of
products.
Employees
On July
31, 2008, we suspended our operations and terminated all our employees due to
the lack of cash resources. Accordingly, we currently have no
employees. Our administrative and other functions are currently being
maintained by our interim Chief Executive Officer and our interim Chief
Financial Officer, both of whom are currently providing their services as
part-time consultants.
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 is removed into the sink department. 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.
“IND” means Investigational
New Drug application.
“IDE” means Investigational
Device Exemption.
“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.
“Plasma” is the clear,
yellowish fluid portion of blood. Plasma differs from serum in that
it contains fibrin and other soluble clotting elements.
“Regeneration” means regrowth
of lost or destroyed parts or organs.
“Sorbent” means to take in and
adsorb or absorb.
ITEM
1.A RISK FACTORS
An
investment in our securities involves a high degree of risk. You
should carefully consider the risks described below before deciding to invest in
or maintain your investment in our company. The risks described below
are not intended to be an all-inclusive list of all of the potential risks
relating to an investment in our securities. If any of the following
or other risks actually occur, our business, financial condition or operating
results and the trading price or value of our securities could be materially and
adversely affected.
RISKS RELATED TO OUR CHAPTER 11
FILING AND PLAN OF
REORGANIZATION
We filed
for reorganization under Chapter 11 of the Bankruptcy Code on
January 9, 2009 and are subject to the risks and uncertainties associated
with the Bankruptcy.
For the
duration of the Bankruptcy, our future operations and our ability to execute our
business strategy will be dependent upon the Bankruptcy Court and subject to the
risks and uncertainties associated with bankruptcy. These risks include our
ability to continue as a going concern; operate within the restrictions and the
liquidity limitations of the Bankruptcy Court; obtain Bankruptcy Court approval
with respect to motions filed in the Bankruptcy from time to time; develop,
confirm and consummate the Plan or an alternative plan of reorganization; obtain
and maintain normal payment terms with critical licensors, vendors and service
providers; and fund and execute our business plan. We will also be
subject to risks and uncertainties with respect to the actions and decisions of
our creditors and other third parties who have interests in the Bankruptcy that
may be inconsistent with our plans.
As a
result of the Bankruptcy, realization of assets and liquidation of liabilities
are subject to uncertainty. While operating under the protection of the
Bankruptcy Code, and subject to Bankruptcy Court approval or otherwise as
permitted in the normal course of business, we may sell or otherwise dispose of
assets, reject certain executory contracts and liquidate or settle liabilities
for amounts other than those reflected in the consolidated financial statements.
Further, a plan of reorganization could materially change the amounts and
classifications reported in the historical consolidated financial statements,
which do not give effect to any adjustments to the carrying value of assets or
amounts of liabilities that might be necessary as a consequence of confirmation
of a plan of reorganization.
We may not be able to obtain
confirmation of our Chapter 11 plan, in which case our Bankruptcy will be
converted into a Chapter 7 liquidation proceeding.
In order
to successfully emerge from Chapter 11 bankruptcy protection, we must
obtain requisite court, stockholder and creditor approval of the Plan or of an
alternative viable Chapter 11 plan of reorganization. This process requires
us to meet certain statutory requirements with respect to adequacy of disclosure
with respect to a plan, soliciting and obtaining creditor acceptance of a plan,
and fulfilling other statutory conditions for confirmation. We may not receive
the requisite acceptances to confirm such a plan. Even if the requisite
acceptances of a plan are received, the Bankruptcy Court may not confirm
it. In addition, the Bankruptcy Court may, on its own volition,
convert the current Chapter 11 bankruptcy proceeding into a Chapter 7
liquidation proceeding. In such a proceeding, all of our assets would
be sold and our company would be liquidated, dissolved and
terminated.
Bankruptcy Court may not
approve the Plan, which will require us to return funds to Arbios Acquisition
Partners, LLC and will result in the loss of the proposed $1,000,000
investment.
If the
Bankruptcy Court does not confirm the Plan by July 15, 2009, we will have to
return the $200,000 payment we will have received from Acquisition Partners,
less the costs and expenses, (including, without limitation, administrative
expenses) that we incur in pursuing the Plan. In addition, our
opportunity to receive the balance of $1,000,000 investment from Arbios
Acquisition Partners, LLC will be lost. Accordingly, if the
Bankruptcy Court does not approve the Plan, unless we have found an alternative
buyer or developed an alternative plan or reorganization, the Bankruptcy will be
converted from a Chapter 11 bankruptcy proceeding into a Chapter 7 liquidation
proceeding in which all of our assets are sold and our company is then
liquidated, dissolved and terminated.
If the Plan is approved, our
stockholders will be diluted and will only own 10% of our outstanding shares,
and all options and warrants, including the warrants owned by our stockholders,
will be cancelled.
The Plan
contemplates that Acquisition Partners will receive new shares equal to 90% of
the shares of our common stock outstanding after the Bankruptcy, and that all of
the current stockholders will only own 10% of the post-Bankruptcy
shares. Accordingly, all of our current stockholders will be severely
diluted if the Plan is confirmed. In addition, all warrants owned by
our stockholders will be cancelled and lost, thereby further reducing the
securities position of our current stockholders in our company.
If the Plan is approved,
Arbios Acquisition Partners, LLC will own most of our shares of voting stock and
will be able to control this company.
If the
Plan is approved, all of our current officers and directors will be replaced by
officers and directors designated by Acquisition Partners. In
addition, Acquisition Partners will own 90% of our voting stock. As a
result, Acquisition Partners will have control over every aspect of our company
and over our future operations. Although Acquisition Partners has
informed us that it intends to further develop our SEPET™ technology, no
assurance can be given that it will do so, nor is Acquisition Partners obligated
to do so. Acquisition Partners has not disclosed its future plans and
strategies for either developing SEPET™ or for the future business/operations of
this company. As a result, investors in our stock will not have any
control over the future direction of our company, nor will our stockholders have
any information about the future plans for our company. No assurance
can be given that Acquisition Partners will, in fact, decide to continue to
develop SEPET™, or if it does elect to continue to develop SEPET™ that it will
be able to do so. If Acquisition Partners does continue to develop
SEPET™, the $1,000,000 that we receive from Acquisition Partners will not be
sufficient to complete the development and, accordingly, Acquisition Partners
will have to raise additional funds. Acquisition Partners will,
therefore, be subject to the same financial, regulatory and other risks and
uncertainties that affected our business and operations prior to the
Bankruptcy.
RISKS
RELATED TO OUR BUSINESS
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, 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.
Our ability to continue as a
going concern is dependent on future financing.
Our
independent registered public accounting firm, has included an explanatory
paragraph in its report on our financial statements for the fiscal year ended
December 31, 2008, which expresses substantial doubt about our ability to
continue as a going concern. Our financial statements have been prepared on the
basis of a going concern, which contemplates the realization of assets and the
satisfaction of liabilities in the normal course of business. We have not made
any adjustments to the financial statements as a result of the outcome of the
uncertainty described above. Accordingly, our value in liquidation may be
different from the amounts set forth in our financial statements.
If we emerge from
bankruptcy, we will need to obtain significant additional capital to complete
the development of SEPET™ and meet contractual obligations related to our
licensed patents, which additional funding may dilute our existing
stockholders.
Based on
our current proposed plans and assumptions, the clinical development expenses to
complete the development of SEPET™ will be very substantial. Based on
our current assumptions, we estimate that the clinical cost of developing the
SEPET™ liver assist device will be approximately $5 million to $10
million. These amounts, which could vary substantially if our
assumptions are not correct and we need to enroll significantly more patients in
our trials, including as a result of the FDA mandating that our pivotal trial of
SEPET™ include a survival-based primary endpoint, are well in excess of the
amount of cash that we expect to have upon the completion of our
Bankruptcy. Accordingly, if the Plan is approved and we emerge from
Bankruptcy, we will have to (i) obtain additional debt or equity financing
in order to fund the further development of our product candidates and working
capital needs, and/or (ii) enter into a strategic alliance with a larger
pharmaceutical or medical device company to provide its required
funding. The amount of funding needed to complete the development of
one or both of our product candidates will be very substantial and may be in
excess of our ability to raise capital.
We have
not yet 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 SEPET™ could
be delayed and we could be forced to limit or terminate our
operations. Any equity additional funding that we obtain will further
reduce the percentage ownership held by our existing security
holders.
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 product candidates 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 product candidates. 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 revenues from the sale of SEPETTM for at
least another year or longer.
Before we can market
SEPETTM, we must obtain
governmental approval, the application and receipt of which is time-consuming,
costly and uncertain.
The
development, production and marketing of our product candidate is subject to
extensive regulation by government authorities in the United States and other
countries. In the United States, our SEPET™ Liver Assist Device will
require approval from the FDA to allow clinical testing and ultimately
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
system, and changes in the FDA’s requirements for our testing during the course
of that testing. 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 SEPET™ and these requirements may be more costly or
time-consuming than we currently anticipate. Since we are required to
include survival as a co-primary endpoint in the planned pivotal trial of
SEPET™, the time to complete the trial and the cost of this trial may be
significantly increased. This could negatively impact our ability to
raise additional capital and could delay the potential commercialization of
SEPET™ in the United States and abroad.
SEPETTM is
novel 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 SEPETTM 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
product candidates. The failure to receive, or any significant delay
in receiving, FDA approval, or the imposition of significant limitations on the
indicated uses of our product candidate, would have a material adverse effect on
our business, operating results and financial condition.
Because SEPET™ is at an
early stage of development and has never been marketed, we do not know if SEPET™
will ever be approved for marketing, and any such approval could take several
years to obtain.
Before
obtaining regulatory approvals for the commercial sale of our product candidate,
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™ product
candidate. While the time periods for testing our product
candidate 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™. We have not independently
confirmed any of the third party claims made with respect to patents, licenses
or technologies we have acquired concerning the potential safety or efficacy of
these product candidates and technologies. Because of the early stage
of development of our product candidate, we do not know if we will be able to
generate additional clinical data that will support the filing of the FDA
application for this product candidate or the FDA’s approval of any product
marketing approval applications or biologic license approval application that we
do file.
Because SEPET™ represents
new approaches to the treatment of liver disease, there are many uncertainties
regarding the development, the market acceptance and the commercial potential of
our product candidate.
Our
SEPET™ product candidate represents a new therapeutic approach for these disease
conditions. If we proceed with the development of SEPET™, we may, as
a result, encounter delays as compared to other product candidates 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 product candidates, if
approved. 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 our product
candidate. Since SEPET™ represents a new approach to treating liver
disease, it may be difficult, in any event, to accurately estimate the potential
revenues from our product candidate, as there currently are no directly
comparable products being marketed.
Immunocept has declared a
default under its license agreement with us, which default may materially affect
our future business plans, including our plans for marketing SEPET™ in the U.S.,
if we are unable to re-instate that license agreement.
Our
business plan to date has assumed that we would attempt to obtain FDA approval
to commercialize SEPET™ in the U.S., while also attempting to obtain the CE
Marking in Europe necessary to commercialize SEPET™ in Europe. We
have assumed that we will have the rights to the patents licensed to us by
Immunocept, which patents only apply in the U.S. and not in Europe at this
time. However, on January 2, 2009, Immunocept, LLC declared a default
in its license agreement with us. We have been in discussions with
Immunocept to reinstate the license agreement and to have that license agreement
assumed in the Plan. However, it is unclear whether we will be able
to maintain that license after the Bankruptcy. Our ability to
commercialize SEPET™ in the U.S. may be affected by our ability continue to use
the Immunocept license. In the event that we are unable to reach an
accommodation with Immunocept, we will not have the right to use the licensed
technologies in the U.S. and would, therefore, have to re-evaluate the effect
that the lack of that license will have on the development of
SEPET™. Failure to have a license to the Immunocept patents may have
a material adverse affect on our business plan and may potentially affect our
ability to market SEPET™ in the U.S. If we do not have the right to
the Immunocept licenses following the Bankruptcy, we may initially choose to
limit our focus on obtaining CE Marking in Europe and commercializing SEPET™ in
Europe. Thereafter, depending on our evaluation of the
Immunocept licenses and on financial and other considerations, we may continue
to seek to obtain FDA marketing approval for SEPET™ in the U.S. or change our
business plan as needed. Therefore, the unavailability of the
Immunocept licensed patents may have a material and adverse effect on our
business plan and on our plans for SEPET™.
We are currently managed by
our interim CEO and CFO on a consulting basis and there is no assurance of
continued access to management services
Our
former CEO and CFO are engaged by us on a limited part-time consulting basis;
however, they may leave the Company to pursue other full-time activities which
would hinder our ability to complete our Plan of reorganization and regulatory
filings on a timely basis. There is no assurance that these
executives will be able to provide management services in the future, and we are
partially dependent on them to complete our Plan of Reorganization and other
regulatory filings needed to consummate the acquisition by Acquisition
Partners.
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, medical device and biotechnology industries are 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
product candidates. Furthermore, many companies are engaged in the
development of medical devices or products that are or will be competitive with
our proposed product. Most of the companies with which we compete
have substantially greater financial, technical, manufacturing, marketing,
distribution and other resources than us.
If we proceed with the
development of SEPET™, we will need to outsource and rely on third parties for
the clinical development and manufacture, supply and marketing of our product
candidates.
Our
business model calls for the outsourcing of the clinical development,
manufacturing, supply and marketing of SEPET™, if approved, in order to reduce
our capital and infrastructure costs. We have not yet entered into
any strategic alliances or other licensing arrangements and there can be no
assurance that we will be able to enter into satisfactory arrangements for these
services or marketing of our product candidates. 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 product candidates covered by the clinical trials conducted under their
management ultimately will generate any revenues for
SEPET™. Consistent with our business model, we will seek to enter
into strategic alliances with other larger companies to market and sell our
product candidates. In addition, we plan to utilize contract
manufacturers to manufacture our product candidates or even our commercial
supplies, and we may contract with independent sales and marketing firms to use
their pharmaceutical or medical device sales force on a contract
basis.
To the
extent that we rely on other companies or institutions to manage the conduct of
our clinical trials and to manufacture or market our product candidates, 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, quality
specifications or cost parameters, the timing of our clinical trials and
development of our product candidates may be adversely affected. Any
manufacturer or supplier that we select, including Membrana and NxStage, 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 any of our
manufacturing or marketing companies, including Membrana and NxStage, encounter
regulatory problems with the FDA, FDA approval of our product candidates could
be delayed or the marketing of our product candidates, if approved, could be
suspended or otherwise adversely affected.
Because we will be dependent
on NxStage and Membrana as the manufacturers of our SEPET™ cartridges, the
termination of our manufacturing agreements, or any other failure or delay by
either NxStage or Membrana to manufacture the SEPETTM
cartridge, will
negatively affect our future operations.
We have
exclusive manufacturing and/or supply arrangements both with NxStage and
Membrana. These manufacturing agreements can be terminated by NxStage
and Membrana after we emerge from Bankruptcy. If NxStage or Membrana terminates
its agreement with us, or if either of them is unable to meet its contractual
obligations to us, we may have difficulty in finding a replacement
manufacturer/supplier. We have no control over NxStage, Membrana or
their suppliers, and if NxStage or Membrana are unable to produce the SEPETTM
cartridges or it’s components on a timely basis, our business may be adversely
affected. Both NxStage and Membrana may elect to cancel our
manufacturing and supply agreements due to our bankruptcy condition which would
adversely our ability to commence a the pivotal clinical trial for SEPETTM and
continue development.
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. In addition to the patents
in-licensed on March 29, 2007, we currently have four patent applications
pending. We have relied substantially on the patent legal work that was
performed for our assignors and licensors and investors with respect to all of
these patents, application and licenses, and have not independently fully
verified the validity or any other aspects of the patents or patent applications
covering our product candidates with our own patent
counsel. For example, we had received from the European Patent
Office an initial rejection of a patent filing citing references to certain
issued patents that may represent prior art in the field of large-pore
hemofiltration. This and potential other prior art may prevent us from obtaining
sufficient legal protection of our proprietary rights to SEPETTM. We
needed to raise an aggregate of $5.2 million during 2008 in order to maintain
the license to the Immunocept patent portfolio that was acquired on March 29,
2007, and there is a possibility that the license may revert to a non-exclusive
basis if we are unsuccessful in negotiating a settlement with Immunocept,
LLC.
Even when
we have obtained patent protection for our product candidates, 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 product
candidates infringe patents or other proprietary rights held by
them.
We
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 market success of
SEPET™, if further developed and eventually approved, will be
dependent in part upon third-party reimbursement policies that have not yet been
established.
Our
ability to successfully penetrate the market for SEPET™, if approved, may depend
significantly on the availability of reimbursement for our product candidate
from third-party payers, such as governmental programs, private insurance and
private health plans. We have not yet established with Medicare or
any third-party payers what level of reimbursement, if any, will be available
for our product candidates, and we cannot predict whether levels of
reimbursement for our product candidates, if any, will be high enough to allow
us to charge a reasonable profit margin. Even with FDA approval,
third-party payers may deny reimbursement if the payer determines that SEPET™ is
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 SEPET™ since they will have to pay for
the un-reimbursed 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 product could diminish or our ability to sell our product
candidate 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 have obtained
clinical trial insurance for our SEPETTM Phase I
feasibility trial; however, we have not procured a policy for the Phase III
pivotal trial due to our financial situation. If we proceed with the
development of SEPET™, we will have to obtain and maintain product liability
insurance for coverage of our clinical trial activities pending the completion
of a strategic transaction, such as the one contemplated in the Plan of
Reorganization. However, there can be no assurance that we will be
able to continue to secure such insurance for clinical trials for
SEPET™. If SEPET™ is approved, we will try to obtain coverage when we
enter the marketplace (as well as requiring the manufacturers of our product
candidates to maintain insurance). We do not know if coverage will be
available to us at acceptable costs or at all. 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.
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. In addition, the public float of our common stock will
decrease if the Plan is approved because the number of shares owned by our
current stockholders will be reduced, thereby potentially reducing the volume of
future stock transactions. 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.
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, or 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) and a
two business day “cooling off period” before brokers and dealers can effect
transactions in penny stocks. Such rules 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.
Potential issuance of
additional common and preferred stock could dilute existing
stockholders.
We are
authorized to issue up to 100,000,000 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.
|
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 changes in the regulations applicable to
us,
|
·
|
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, medical device 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 Annual
Report.
|
ITEM
1B. UNRESOLVED STAFF COMMENTS
Not
applicable.
ITEM
2. DESCRIPTION OF PROPERTY
We
maintain our corporate headquarters in an office in Pasadena, California. The
office is leased on a month-to-month basis for approximately $750 per month for
300 square feet of space. We believe our office space is adequate for our
current needs.
ITEM
3. LEGAL PROCEEDINGS
We are
not a party to any material 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.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No
matters were submitted to a vote of security holders during the quarter ended
December 31, 2008.
Market
Information
Our
common stock was traded on the OTC Bulletin Board over-the-counter market under
the symbol “ABOS.OB” until the Bankruptcy filing on January 9,
2009. Commencing with the Bankruptcy filing, our common stock has
been listed for trading on the OTC Bulletin Board under the symbol
“ABOSQ.OB”.
The
following table sets forth the range of high and low bid information for our
common stock for each quarter within the last two years, as reported by Yahoo
Finance and Bigcharts from CBS Marketwatch.com. 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, 2007
|
|
$ |
1.10 |
|
|
$ |
0.43 |
|
June
30, 2007
|
|
$ |
0.89 |
|
|
$ |
0.60 |
|
September
30, 2007
|
|
$ |
0.85 |
|
|
$ |
0.29 |
|
December
31, 2007
|
|
$ |
0.75 |
|
|
$ |
0.55 |
|
|
|
|
|
|
|
|
|
|
March
31, 2008
|
|
$ |
0.30 |
|
|
$ |
0.26 |
|
June
30, 2008
|
|
$ |
0.19 |
|
|
$ |
0.08 |
|
September
30, 2008
|
|
$ |
0.04 |
|
|
$ |
0.03 |
|
December
31, 2008
|
|
$ |
0.01 |
|
|
$ |
0.01 |
|
Holders
As of
March 31, 2009, there were 109 listed shareholders of record of our common
stock, although we believe there may be substantially more shareholders who hold
our common stock in street name.
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 our 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.
Issuances
of Unregistered Securities; Issuer Purchases of Equity Securities
We did
not issue any unregistered securities during the three-month period ended
December 31, 2008 that were not previously reported in a Current Report on Form
8-K, and we did not repurchase any securities during that period.
Equity
Compensation Plan Information
See Part
III, Item 12, Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters, of this Annual Report on Form 10-K for information
regarding securities authorized for issuance under our equity compensation
plans.
Not
applicable to a “smaller reporting company” as defined in Item 10(f)(1) of SEC
Regulation S-K.
ITEM
7. MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Overview
During
the past few years, 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. Substantially all of the revenues that we have recognized
to date have been from the sale of our HepatAssistTM system
in October 2008 and Small Business Innovation Research grants (in an aggregate
amount of $321,000) that we received from the U.S. Small Business
Administration.
In May
2008, we received approval from the FDA to commence a Phase II/III pivotal
clinical trial for SEPETTM. We
estimated that the cost of completing these trials was between $5 million and
$10 million. As we have done since our inception, we intended to
raise the funds to complete our development from financing
transactions. Unfortunately, because of the global economic crisis in
2008 and the dramatic decline in the availability of financing, particularly to
development stage companies like ours, we were unable to raise the capital we
needed to finance our operations and development activities. As a
result, in order to preserve our remaining cash while seeking financing and
while attempting to otherwise maximize the value of our assets, in mid-2008 we
terminated all of our employees and suspended our operations. We have
not conducted any active operations since mid-2008, and our sole activity since
that time has been to (i) seek sufficient capital to re-initiate our operations,
(ii) find a strategic partner to co-develop our technologies with us, or (iii)
sell our technologies and assets in a manner that will maximize shareholder
value.
On
January 9, 2009, this company filed a voluntary petition for relief under
Chapter 11 of the Bankruptcy Code with the United States Bankruptcy Court for
the District of Delaware. We are continuing to exist as a
debtor-in-possession under the jurisdiction of the Bankruptcy
Court.
On March
9, 2009, we entered into a Term Sheet with Acquisition Partners pursuant to
which Acquisition Partners agreed to invest $1,000,000 for the purchase of 90%
of our common stock. To date, Acquisition Partners has paid us
$100,000 of that purchase price, part or all of which may need to be refunded
under certain circumstances. The investment described in the Term
Sheet has not been approved by the Bankruptcy Court, and a hearing is scheduled
to be held on April 20, 2009 to obtain the requisite
approval. Assuming the Bankruptcy Court approves that Term Sheet,
that transaction and the balance of our plan or reorganization will be submitted
to our creditors and stockholders for approval.
In order
to have sufficient funds to operate, in October 2008, we sold the
HepatAssistTM
Cell-Based Liver Support System to HepaLife Technologies, Inc.
(“HepaLife”). We had purchased HepatAssistTM in
April 2004 for $450,000 but have not further developed that
technology. We agreed to sell HepatAssistTM to
HepaLife for (a) $450,000 in cash, of which $250,000 was paid in October 2008
and the remaining $200,000 was deferred for up to 18 months from the date of
sale, and (b) a warrant to purchase 750,000 shares of HepaLife common stock at
an exercise price of $0.35 per share. On April 1, 2009, we agreed to
return the warrant to HepaLife, and HepaLife agreed to pay us the $200,000
deferred payment now. A hearing to approve the repurchase by HepaLife
of its warrant in consideration for accelerating the $200,000 payment is
scheduled for April 20, 2009.
Our
future operations, if any, will depend upon whether the Bankruptcy Court
confirms the Plan or any other plan of reorganization under Chapter
11.
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, 2008. 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, or FASB, Statement of Financial Accounting Standards, or 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 SFAS No. 2, “Accounting for Research and Development Costs,” or
SFAS 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
Commencing
January 1, 2006 we adopted SFAS No. 123R, “Share Based Payment,” or SFAS 123R,
which requires all share-based payments, including grants of stock options, to
be recognized in the income statement as an operating expense, based on fair
values. Prior to adopting SFAS 123R, we accounted for stock-based employee
compensation under Accounting Principles Board Opinion No. 25, “Accounting for
Stock Issued to Employees,” as allowed by SFAS No. 123, “Accounting for
Stock-Based Compensation”. We have applied the modified prospective
method in adopting SFAS 123R. Accordingly, periods prior to adoption
have not been restated.
New
Accounting Pronouncements
In
September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” or SFAS
157. SFAS 157 establishes a single authoritative definition of fair value, sets
out a framework for measuring fair value, and requires additional disclosures
about fair-value measurements. SFAS 157 applies only to fair value measurements
that are already required or permitted by other accounting standards (except for
measurements of share-based payments) and is expected to increase the
consistency of those measurements. Accordingly, SFAS 157 does not require any
new fair value measurements. However, for some entities, the application of SFAS
157 will change current practice. SFAS 157 is effective for fiscal years
beginning after November 15, 2007, and interim periods within those fiscal
years. The adoption of FAS 157 did not have a material impact on the financial
position or results of operations.
In
February 2007, the FASB issued FASB Statement No.159: “The Fair Value Option for
Financial Assets and Financial Liabilities – including an amendment of FASB
Statement No. 115” (“FAS 159”). This statement permits entities to choose to
measure many financial instruments and certain other items at fair value and is
expected to expand the use of fair value measurement. FASB 159 is effective for
fiscal years beginning after November 15, 2007. The Company has adopted FAS 159
and the adoption did not have a material impact on the financial position or
results of operations.
On June
27, 2007, the FASB reached a final consensus on EITF Issue No. 07-03:
“Accounting for Advance Payments for Goods or Services to Be Used in Future
Research and Development Activities” (“EITF 07-03”). Currently, under FASB
Statement No. 2: “Accounting for Research and Development Costs,” nonrefundable
advance payments for future research and development activities for materials,
equipment, facilities and purchased intangible assets that have no alternative
future use are expensed as incurred. EITF 07-03 addresses whether such
non-refundable advance payments for goods or services that have no alternative
future use and that will be used or rendered for research and development
activities should be expensed when the advance payments are made or when the
research and development activities have been performed. The consensus reached
by the FASB requires companies involved in research and development activities
to capitalize such non-refundable advance payments for goods and services
pursuant to an executory contractual arrangement because the right to receive
those services in the future represents a probable future economic benefit.
Those advance payments will be capitalized until the goods have been delivered
or the related services have been performed. Entities will be required to
evaluate whether they expect the goods or services to be rendered. If an entity
does not expect the goods to be delivered or services to be rendered, the
capitalized advance payment will be charged to expense. The consensus on EITF
07-03 is effective for financial statements issued for fiscal years beginning
after December 15, 2007, and interim periods within those fiscal years. Earlier
application is not permitted. Entities are required to recognize the effects of
applying the guidance in EITF 07-03 prospectively for new contracts entered into
after the effective date. In accordance with EITF 07-03, the Company does
evaluate its research and development contracts and payments within the guidance
of EITF 07-03 and either expenses or capitalizes such payments based upon the
contract terms.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities” The new standard is intended to improve financial
reporting about derivative instruments and hedging activities by requiring
enhanced disclosures to enable users of the financial statements to better
understand the effects on an entity’s financial position, financial performance,
and cash flows. It is effective for financial statements issued for fiscal years
and interim periods beginning after November 15, 2008, with early application
encouraged. The Company is evaluating the impact of adopting SFAS 161 on our
financial statements.
Results
of Operations
Comparison
of Fiscal Year ended December 31, 2008 to Fiscal Year ended
December 31, 2007.
Since we
have been engaged in developing our product candidates and do not have any
products available for sale, we did not generate any revenues from sales during
fiscal year ended December 31, 2007 (“fiscal 2007”) or December 31, 2008
(“fiscal 2008”).
General
and administrative expenses of $1,499,914 and $3,420,048 were incurred for the
years ended December 31, 2008 and 2007, respectively. For fiscal
2008, the expenses include $729,000 in fees incurred to outside consultants and
professionals, $331,000 in non-cash option and warrant charges, $116,000 in
payroll and payroll related costs, $104,000 in insurance costs, $56,000 in rent
and other administrative expenses. For fiscal 2007, the expenses
include $976,000 in fees incurred to outside consultants and professionals,
$788,000 in payroll and payroll related costs, $715,000 in non-cash option and
warrant charges, $135,000 in investor relation costs, $180,000 in equity
offering contingent charges and other administrative
expenses. Professional fees decreased in 2008 due to decreased patent
and general legal costs of $167,000 from curtailed patent work and a decline in
contract negotiating activity in 2008. A $114,000 charge in fiscal
2008 related to costs incurred with a failed fund raising effort, while we
incurred a charge of a $114,000 as a executive search recruitment fee related to
our search for a new Chief Executive Officer in 2007. The decrease in
non-cash option and warrant charges reflect lower fair value option charge
calculations which are impacted by a declining common stock market price in 2008
and a reduction in option grants in 2008. The 2008 decrease in
payroll and payroll related expenses reflect the vacant Chief Executive Officer
position in 2008 and the termination of all administrative positions in August
2008. An equity offerings contingency for $180,000 was accrued in the
first quarter of 2007.
Research
and development expenses of $1,212,824 and $2,299,632 were incurred for the
years ended December 31, 2008 and 2007, respectively. Research and
development expenses for fiscal 2008 consisted primarily of $547,000 in payroll
and payroll related expenses, $205,000 in SEPETTM
development, manufacturing and clinical costs, $242,000 in consultant costs
related to manufacturing, regulatory and product management, $50,000 in patent
acquisition costs, and $12,000 in HepatAssist™ facility costs. Research and
development expenses for fiscal 2007 consisted primarily of $635,000 in payroll
and payroll related expenses, $299,000 in SEPETTM
development, manufacturing and clinical costs, $701,000 in consultant costs
related to manufacturing, regulatory and product management, $425,000 in patent
acquisition costs, and $36,000 in HepatAssist™ facility
costs. Research and development costs decreased by $1,086,808 from
fiscal 2007 to fiscal 2008 due to $375,000 in costs related to the Immunocept,
LLC patent portfolio acquisition in March 2007, a decline in SEPETTM
development costs of $94,000 in fiscal 2008, the development of which has been
placed on hold until additional capital is secured, and a decline in consultant
costs of $459,000 also related to the SEPETTM
program’s suspension. Payroll expenses declined in fiscal 2008 by
$88,000 compared to fiscal 2007 due to the termination of all of our remaining
employees in July 2008.
Interest
income of $34,374 and $167,030 was earned for the years ended December 31, 2008
and 2007 respectively. The decrease in interest income of $132,656
results from lower average cash balances maintained in 2008.
Our net
loss decreased to $2,273,501 in fiscal 2008 from $5,552,650 in fiscal
2007. The decrease in net loss is attributed to a decrease in
operating expenses incurred in the fiscal 2008 period as compared to the same
periods in fiscal 2007 as we suspended all of our operations and focused our
efforts on obtaining financing or consummating a strategic
transaction.
Liquidity
and Capital Resources
As of
December 31, 2008, we had cash and cash equivalents of $370,686, current
liabilities of $480,934, and long-term contract obligations of $150,000 related
to patent acquisitions. To date, we have funded our operations
primarily from the sale of debt and equity securities, and to a lesser extent,
the sale of our HepatAssistTM system
and SBIR grants.
We do not
have any bank credit lines. 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 nor do we anticipate that we
will derive any revenue from either product sales or from governmental research
grants in the foreseeable future. The cost of completing the development of our
product candidates and of obtaining all required regulatory approvals to market
our product candidates 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.
On
January 9, 2009 we filed for protection under Chapter 11 of the U.S. Bankruptcy
Code in the United States Bankruptcy Court for the District of
Delaware. The Bankruptcy enabled us to continue to seek investors in
our equity and bids for the purchase of our assets while working with our
creditors. Our Board of Directors determined that, in light of our
limited cash position and the current economic conditions and financial markets,
the best course of action was to obtain financing and/or sell our assets under
bankruptcy protection.
Our
operating expenses while in Bankruptcy have been funded from our remaining cash
reserves. In addition, we anticipate that we will receive $200,000
shortly after the Bankruptcy Court hearing that will be held on April 20, 2009
to approve the return to HepaLife of the warrant to purchase 750,000 shares of
HepaLife common stock that we currently own. If the Bankruptcy Court
approves the HepaLife transaction, we will receive the $200,000 payment in April
2009. In addition, we have also received a total of $100,000 in cash
from Acquisition Partners, with an additional $100,000 to be received shortly as
part of the $1,000,000 investment we will receive from Acquisition Partners
under the Term Sheet, if the Term Sheet and the Plan are approved by the
Bankruptcy Court. The foregoing funds constitute our sole source of
liquidity. However, based on the estimated duration of our bankruptcy
proceedings and on our scheduled expenses, we anticipate that we have sufficient
funds to pay all of our post petition administrative costs and
expenses. The allowed General Unsecured Claim Holders will receive
90% of the principal amount of their Allowed Claim and any other obligations
that we are required to satisfy in Bankruptcy Court.
If the
Plan is approved and the $1,000,000 investment by Acquisition Partners is fully
funded, we expect to emerge from Bankruptcy within the next few months with
little or no liabilities, other than our obligations to Immunocept (and other
contractors) under our licenses, and approximately $500,000 in
cash. The cash balances that we will have in place
if the Bankruptcy Court approves our Plan and we emerge from bankruptcy will not
be sufficient to complete the development of SEPETTM. Accordingly,
depending on whether we continue to develop SEPETTM and
other research and development opportunities, we will have to raise additional
proceeds to fund our operating and development expenses in the
future.
A summary
of our contractual cash obligations at December 31, 2008 is as
follows:
Contractual
Obligations
|
|
Total
|
|
|
2009
|
|
|
2010
|
|
|
2011
|
|
|
2012
|
|
License
Agreement
|
|
$ |
250,000 |
|
|
$ |
100,000 |
|
|
$ |
150,000 |
|
|
|
- |
|
|
|
- |
|
Total
|
|
$ |
250,000 |
|
|
$ |
100,000 |
|
|
$ |
150,000 |
|
|
$ |
- |
|
|
$ |
- |
|
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.
Not
applicable to a “smaller reporting company” as defined in Item 10(f)(1) of SEC
Regulation S-K.
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
The
consolidated financial statements and the reports and notes, which are attached
hereto beginning at page F-1, are incorporated herein by reference.
Not
applicable.
ITEM
9A(T). CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure
Controls and Procedures. As of the end of the period covered by this
report, our company conducted an evaluation, under the supervision and with the
participation of our Interim Chief Executive Officer and Chief Financial
Officer, of our disclosure controls and procedures (as defined in
Rules 13a-15(e) of the Exchange Act). Based on this evaluation,
our Interim Chief Executive Officer and Interim Chief Financial Officer
concluded that our company’s disclosure controls and procedures are effective to
ensure that information required to be disclosed by us in reports that we file
or submit under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in Securities and Exchange Commission rules
and forms, and that such information is accumulated and communicated to our
management, including our chief executive officer and chief financial officer,
as appropriate, to allow timely decisions regarding required
disclosures.
(b) Changes in Internal
Controls. There was no change in our internal controls, which are
included within disclosure controls and procedures, during our most recently
completed fiscal quarter that has materially affected, or is reasonably likely
to materially affect, our internal controls.
(c) Management’s Report
on Internal Control over Financial Reporting. The management of the
company is responsible for establishing and maintaining adequate internal
control over financial reporting. Internal control over financial reporting is
defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process
designed by, or under the supervision of, the company’s principal executive and
principal financial officers and effected by the company’s board of directors,
management and other personnel to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting
principles. The company’s internal control over financial reporting
includes those policies and procedures that:
|
·
|
pertain
to the maintenance of records that, in reasonable detail, accurately and
fairly reflect the transactions and dispositions of the assets of the
company;
|
|
·
|
provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of management and
directors of the company; and
|
|
·
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the company’s assets that
could have a material effect on the financial
statements.
|
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
The
company’s management assessed the effectiveness of the company’s internal
control over financial reporting as of December 31, 2008. In making this
assessment, management used the criteria set forth by the Committee of
Sponsoring Organizations of the Treadway Commission (COSO) in Internal
Control-Integrated Framework. Based on our assessment, management
believes that, as of December 31, 2008, the company’s internal control over
financial reporting is effective based on those criteria.
This
Annual Report does not include an attestation report of the company’s registered
public accounting firm regarding internal control over financial
reporting. Management’s report was not subject to attestation by the
company’s registered public accounting firm pursuant to temporary rules of the
Securities and Exchange Commission that permit the company to provide only a
management’s report in this Annual Report.
(d) Limitations on the
Effectiveness of Controls. Our management, including our
Interim Chief Executive Officer and Interim Chief Financial Officer, does not
expect that our disclosure controls and procedures or our internal control over
financial reporting will prevent all error and all fraud. A control system, no
matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. Further,
the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their
costs. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances
of fraud, if any, within an organization have been detected. These inherent
limitations include the realities that judgments in decision-making can be
faulty, and that breakdowns can occur because of simple error or
mistake.
Additionally,
controls can be circumvented by the individual acts of some persons, by
collusion of two or more people, or by management override of the control. The
design of any system of controls also is based in part upon certain assumptions
about the likelihood of future events, and there can be no assurance that any
design will succeed in achieving our stated goals under all potential future
conditions. Over time, controls may become inadequate because of changes in
conditions, or the degree of compliance with the policies or procedures may
deteriorate. Because of the inherent limitations in a cost-effective control
system, misstatements due to error or fraud may occur and not be
detected.
ITEM
9B. OTHER INFORMATION
None.
PART
III
The
following table sets forth the name, age and position held by each of our
directors and executive officers as of March 31, 2009. Directors are
elected at each annual meeting and thereafter serve until the next annual
meeting at which their successors are duly elected by the
stockholders. Upon the confirmation of the Plan, all of the directors
and executive officers listed below will resign, and new officers and directors
will be appointed. If the Plan of Reorganization is confirmed, the
new officers and directors are expected to be the following persons who have
been designated by Acquisition Partners: Tom Fagan--Director,
Chairman of the Board, CEO and President; Cara Fagan--Director, Secretary and
Treasurer; John Desiderio--Director. Accordingly, none of the
following persons will be an officer or director of this company after the
Bankruptcy.
Name
|
|
Age
|
|
Position
|
Shawn
P. Cain
|
|
42
|
|
Interim
President and Chief Executive Officer
|
Scott
L. Hayashi
|
|
37
|
|
Interim
Vice President Finance and Administration, Chief Financial Officer and
Secretary
|
John
M. Vierling, M.D., FACP
(2)
|
|
63
|
|
Director,
Chairman of the Board
|
Amy
Factor
|
|
51
|
|
Director,
Vice Chairman of the Board
|
Jack
E. Stover
(1)
|
|
56
|
|
Director
|
Thomas
C. Seoh (1)(3)
|
|
51
|
|
Director
|
Thomas
M. Tully (1)(2)(3)
|
|
63
|
|
Director
|
Dennis
Kogod (2)(3)
|
|
49
|
|
Director
|
(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 our current executive officers and
directors.
Shawn P. Cain. Mr. Cain
has been our Interim President and Chief Executive Officer since September
2007. As an interim officer, Mr. Cain works for us on a limited
part-time consulting basis. He joined us as our 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 our former
HepatAssistTM product
candidate.
Scott L. Hayashi. Mr. Hayashi
has been our Interim Chief Financial Officer since March 2005. As an
interim officer, he works for us on a limited part-time consulting
basis. Mr. Hayashi joined us as our Chief Administrative Officer in
February 2004, became our Secretary in July 2004 and was appointed as the Vice
President of Administration in November 2004. Prior to joining us,
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.
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.
Amy Factor. Ms.
Factor was appointed as a director and Vice Chairman in September
2007. Prior to this, Ms. Factor served as a director from March 2005
until July 2006, and she was our interim Chief Executive Officer from April 2005
until November 2005. Ms. Factor has provided us with strategic and financial
consulting services from November 2003 until the present. 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 Chief Financial Officer of Immunomedics,
Inc.
Jack E.
Stover. Mr. Stover has served as a director since
November 2004. Mr. Stover is a director of PDI, Inc. and was
previously served as a director and CEO of Antares Pharma, Inc. (a public
specialty pharmaceutical company) from July 2004 to October 2008. 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 private 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 (then Coopers & Lybrand), working in
their bioscience industry division. Mr. Stover is also a
CPA.
Thomas C. Seoh. Mr.
Seoh has served as a director since March 2005. From February 2006
until July 2008, Mr. Seoh 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 Schneider (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 L.
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.
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. According to the Audit Committee Charter, the Audit
Committee is to meet periodically with our 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
of Directors 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 of Directors, is independent as
defined under the Nasdaq Stock Market’s listing standards. Mr. Stover
is our “audit committee financial expert” as defined under Item 407(d)(5)
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 Compensation
Committee evaluates management performance goals with the Chief Executive
Officer periodically and considers appropriate bonuses and salary adjustments
based on achievement of objectives. The Compensation Committee can
retain outside consultants to assist in determining compensation if needed. The
Compensation Committee is currently composed of Mr. Tully, Dr. Vierling and Mr.
Kogod.
The
Nomination Committee assists the Board of Directors in identifying qualified
candidates, selecting nominees for election as directors at meetings of
stockholders and selecting candidates to fill vacancies on our Board of
Directors, and developing criteria to be used in making such recommendations.
The Nomination Committee evaluates relevant experience and leadership skills for
director candidates. The Nomination Committee is currently comprised
of Mr. Tully, Mr. Seoh and Mr. Kogod.
Section
16(a) Beneficial Ownership Reporting Compliance
Our
records reflect that all reports which were required to be filed pursuant to
Section 16(a) of the Exchange Act were filed on a timely basis.
An Annual
Statement of Beneficial Ownership on Form 5 is not required to be filed if there
are no previously unreported transactions or holdings to
report. Nevertheless, we are required to disclose the names of
directors, officers and 10% shareholders who did not file a Form 5 unless we
have obtained a written statement that no filing is required. We have received a
written statement from each of our other directors, officers and 10%
shareholders stating that no filing is required.
Code
of Ethics
The Board
of Directors adopted a Code of Ethics that covers all of our executive officers
and key employees. The Code of Ethics requires that senior management
avoid conflicts of interest; maintain the confidentiality of our confidential
and proprietary information; engage in transactions in our common stock only in
compliance with applicable laws and regulations and the requirements set forth
in the Code of Ethics; and comply with other requirements which are intended to
ensure that our officers conduct business in an honest and ethical manner and
otherwise act with integrity and in the best interest of this
company. All of our executive officers are required to affirm in
writing that they have reviewed and understand the Code of Ethics.
A copy of
our Code of Ethics will be furnished, without charge, to any person upon written
request from any such person. Requests should be sent
to: Secretary, Arbios Systems, Inc., 200 E. Del Mar Blvd., Suite 320,
Pasadena, CA 91105.
Disclosure
regarding any amendments to, or waivers from, provisions of the Code of Ethics
that apply to our directors, principal executive and financial officers will be
included in a Current Report on Form 8-K within four business days following the
date of the amendment or waiver, unless website posting of such amendments or
waivers is then permitted by the rules of the market or exchange on which our
common stock is then listed, in which case we intend to post such amendments or
waivers on our website, www.arbios.com.
SUMMARY
COMPENSATION TABLE
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, 2008 and 2007 of (i) all persons who served as
our principal executive officer and principal financial officer during the
fiscal year ended December 31, 2008, (ii) our two other most highly compensated
executive officers (whose total annual compensation during the fiscal year ended
December 31, 2008 exceeded $100,000) who were not executive officers at December
31, 2008. The principal executive officer and the other named
officers are collectively referred to as the “Named Executive
Officers.”
Name
and Principal Position
|
|
Year
|
|
Salary
|
|
|
Bonus
|
|
|
Option
Awards(1)
|
|
|
All
Other Compensa-tion(2)
|
|
|
Total
|
|
Shawn
P. Cain(3)
|
|
2008
|
|
$ |
95,583 |
|
|
$ |
20,000 |
|
|
$ |
19,956 |
|
|
$ |
100,891 |
|
|
$ |
236,430 |
|
Interim
President and Chief Executive Officer
|
|
2007
|
|
$ |
170,624
|
|
|
$ |
10,000
|
|
|
$ |
39,104
|
|
|
$ |
4,818
|
|
|
$ |
224,546
|
|
Jacek
Rozga, M.D. Ph.D. (4)
|
|
2008
|
|
$ |
103,334 |
|
|
|
- |
|
|
$ |
9,033 |
|
|
$ |
34,333 |
|
|
$ |
146,700 |
|
Former
Chief Scientific Officer
|
|
2007
|
|
$ |
155,000
|
|
|
|
-
|
|
|
$ |
14,126
|
|
|
$ |
23,177
|
|
|
$ |
192,303
|
|
Scott
L. Hayashi (5)
|
|
2008
|
|
$ |
64,584 |
|
|
|
- |
|
|
$ |
17,211 |
|
|
$ |
53,169 |
|
|
$ |
134,964 |
|
Interim
Vice President of Administration, Chief Financial Officer and
Secretary
|
|
2007
|
|
$ |
121,250
|
|
|
$ |
10,000 |
|
|
$ |
23,662
|
|
|
$ |
3,506
|
|
|
$ |
158,418
|
|
Susan
Papalia
(6)
|
|
2008
|
|
$ |
87,833 |
|
|
|
- |
|
|
$ |
8,049 |
|
|
$ |
32,861 |
|
|
$ |
128,743 |
|
Former
Vice President of Clinical Affairs
|
|
2007
|
|
$ |
21,250 |
|
|
|
-
|
|
|
$ |
1,725 |
|
|
$ |
425 |
|
|
$ |
23,400 |
|
(1)
|
Represents
the compensation expense incurred by us in the applicable fiscal year in
connection with option grants to the applicable Named Executive Officer,
calculated in accordance with SFAS 123R disregarding the estimate of
forfeitures for service-based vesting conditions. See our
audited consolidated financial statements included elsewhere in this
Annual Report for details as to the assumptions used to determine the fair
value of the option awards. Our Named Executive Officers will not realize
the value of these awards in cash until these awards are exercised and the
underlying shares are subsequently
sold.
|
(2)
|
Includes
company matching contributions in the Arbios 401(k) Plan, severance
payments, vacation payout and consulting
fees.
|
(3)
|
In
September 2007, Mr. Cain was appointed as this company’s Interim President
and Chief Executive Officer. In July 2008, Mr. Cain’s full-time
employment was terminated and he was retained on a part-time consulting
basis. Mr. Cain was paid a $20,000 cash bonus in October 2008 related to
the sale of the HepatAssistTM
product to HepaLife Technologies, Inc. In “Other Compensation” for 2008,
Mr. Cain received a 401K matching contribution of $925, three months
salary severance payment totaling $46,250, vacation payout of $7,471,
extended health benefits of $6,245 and consulting fees of
$40,000.
|
(4)
|
Dr.
Rozga worked as a consultant from January 2007 to March 2007 and became a
full-time employee in April 2007. In July 2008, Dr. Rozga’s full-time
employment as the Chief Scientific Officer was terminated. In “Other
Compensation” for 2007, Dr. Rozga earned $10,000 as a consultant and had
$3,500 of company matching contributions in his 401K and had $9,677 of
relocation allowance to move him from Los Angeles to Boston. In
“Other Compensation” for 2008, Dr. Rozga received severance of two months’
salary totaling $33,333 and company matching contributions in his 401K of
$1,000.
|
(5)
|
In
July 2008, Mr. Hayashi’s full-time employment was terminated, and he was
thereafter retained on a part-time consulting basis. In “Other
Compensation” for 2008, Mr. Hayashi received company matching
contributions in his 401K of $625, two months’ salary severance payment of
$20,833, vacation payout of $7,211, and consulting fees of
$24,500.
|
(6)
|
In
November 2007, Ms. Papalia was hired as this company’s Vice President of
Clinical Affairs. In July 2008, the Company terminated Ms.
Papalia’s full-time employment. In “Other Compensation” for
2008, Ms. Papalia received company matching contributions of $850, two
months’ salary severance payment of $28,333 and vacation payout of
$3,678.
|
OUTSTANDING
EQUITY AWARDS AT FISCAL YEAR-END
The
following table sets forth the number and value of unexercised options held by
the Named Executive Officers as of December 31, 2008. There were
no exercises of options by the Named Executive Officers in fiscal year
2008. This company did not
issue any stock awards to any of the Named Executive Officers, and the Named
Executive Officers do not hold any stock awards. Under the Plan of
Reorganization, all outstanding options will be cancelled upon the confirmation
of the Plan of Reorganization.
Name
|
|
Number
of Securities Underlying Unexercised Options
(#) Exercisable
|
|
|
Number
of Securities Underlying Unexercised
Options(#) Unexercisable
|
|
|
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned Options (#)
|
|
|
Option
Exercise Price
$
|
|
Option
Expiration
Date
|
Shawn
P. Cain
|
|
|
30,000 |
|
|
|
70,000 |
|
|
|
100,000 |
(1) |
|
$ |
0.49 |
|
9/21/2014
|
|
|
|
78,125 |
|
|
|
71,875 |
|
|
|
150,000 |
(2) |
|
$ |
0.82 |
|
5/10/2014
|
|
|
|
48,125 |
|
|
|
21,875 |
|
|
|
70,000 |
(3) |
|
$ |
0.85 |
|
7/31/2013
|
|
|
|
30,000 |
|
|
|
- |
|
|
|
30,000 |
(4) |
|
$ |
1.65 |
|
3/31/2010
|
Scott
L. Hayashi
|
|
|
5,000 |
|
|
|
65,000 |
|
|
|
70,000 |
(5) |
|
$ |
0.49 |
|
9/21/2014
|
|
|
|
78,125 |
|
|
|
71,875 |
|
|
|
150,000 |
(6) |
|
$ |
0.82 |
|
5/10/2014
|
|
|
|
27,500 |
|
|
|
12,500 |
|
|
|
40,000 |
(7) |
|
$ |
0.85 |
|
7/31/2013
|
|
|
|
10,000 |
|
|
|
- |
|
|
|
10,000 |
(8) |
|
$ |
1.85 |
|
3/24/2010
|
|
|
|
12,000 |
|
|
|
- |
|
|
|
12,000 |
(9) |
|
$ |
2.90 |
|
3/1/2010
|
|
|
|
10,000 |
|
|
|
- |
|
|
|
10,000 |
(10) |
|
$ |
2.25 |
|
2/9/2009
|
* Dr.
Jacek Rozga and Susan Papalia are not included in the foregoing table because,
as of December 31, 2008, neither of them owned any options or stock
awards. Dr. Rozga’s and Ms. Papalia’s options were all canceled in
October 2008 because their employment was terminated in July 2008 and they did
not exercise their options within 90 day exercise period following their
termination provided to them in their option agreements.
(1)
|
The
option to purchase 100,000 shares of common stock was granted on
09/21/2007 and vests based on achievement of performance based milestones
during 2007 and 2008. 70,000 shares were canceled due to not achieving
certain milestones
|
(2)
|
The
option to purchase 150,000 shares of common stock was granted on
05/10/2007 and vests on a pro-rata monthly basis for a period of 48 months
from the date of grant.
|
(3)
|
The
option to purchase 70,000 shares of common stock was granted on 7/31/2006
and vests on a pro-rata monthly basis for a period of 48 months from the
date of grant.
|
(4)
|
The
option to purchase 30,000 shares of common stock was fully vested on
4/22/2007.
|
(5)
|
The
option to purchase 70,000 shares of common stock was granted on 9/21/2007
and vests according to achievement of performance based milestones during
2007 and 2008. 65,000 shares were canceled due to not achieving
certain milestone.
|
(6)
|
The
options to purchase 150,000 shares of common stock were granted on
5/10/2007 and vest on a pro-rata monthly basis for a period of 48 months
from the date of grant.
|
(7)
|
The
option to purchase 40,000 shares of common stock was granted on 7/31/2006
and vests on a pro-rata monthly basis for a period of 48 months from the
date of grant.
|
(8)
|
The
option to purchase 10,000 shares of common stock was fully vested on
3/24/2006.
|
(9)
|
The
option to purchase 12,000 shares of common stock was fully vested on
2/1/2006.
|
(10)
|
The
option to purchase 10,000 shares of common stock was fully vested on
2/11/2005.
|
Employment
Contracts and Termination of Employment, and Change-In-Control
Arrangements
On July
31, 2008, we terminated Mr. Cain as a full-time employee and President and Chief
Executive Officer. As part of his separation agreement, Mr. Cain
received severance equivalent to three months salary ($46,250) and his unused
vacation pay of $7,471. On August 1, 2008, we entered into a
part-time consulting arrangement whereby Mr. Cain agreed to act as our Interim
Chief Executive Officer for 30 days for $5,000 per month, which offer was
verbally extended on September 1, 2008. On October 6, 2008, we
entered into a formal Compensation Agreement with Mr. Cain pursuant to which he
agreed to serve on a limited part-time consulting basis as the Interim President
and Chief Executive Officer. The Compensation Agreement is
retroactively effective as of October 1, 2008. Under the compensation
agreement, Mr. Cain agreed to assist this company at least until December 31,
2008 in selling, licensing or otherwise financing our assets. In consideration
for his services, we agreed to pay Mr. Cain (i) $10,000 per month plus payment
of medical insurance, estimated to be approximately $1,500 per month, and (ii)
an incentive cash bonus following the sale, license or financing of our SEPET
assets, which incentive payment will be determined in the sole discretion of the
Board after taking into account the timing, size and structure of the
transaction. In addition, under the compensation agreement, we paid
Mr. Cain a cash bonus of $20,000 as compensation for his services in connection
with the sale of the HepatAssist assets to HepaLife Technologies,
Inc. Mr. Cain’s consultancy was verbally extended on January 1, 2009
on a month to month basis whereby he is entitled to receive the $10,000 per
month retainer and continuation of health benefits.
On July
31, 2008, we terminated the full-time employment of Jacek Rozga, M.D., Ph.D.,
our Chief Scientific Officer. As part of his separation agreement,
Dr. Rozga received severance equivalent to two months salary of
$33,333.
On July
31, 2008, we terminated the full-time employment of Susan Papalia, R.N., our
Vice President of Clinical Affairs. As part of her separation
agreement, Ms. Papalia received severance equivalent to two months salary of
$28,333 and vacation payout of $3,678.
On July
31, 2008, we terminated the full-time employment of Scott Hayashi, our Vice
President of Finance and Administration and Chief Financial
Officer. As part of his separation agreement, Mr. Hayashi received
severance equivalent to two months salary of $20,833 and vacation payout of
$7,211. On August 1,
2008, we entered into a part-time consulting arrangement with Mr. Hayashi
pursuant to which he agreed to act as our Interim CFO for 30 days for $5,000 per
month, which offer was verbally extended on September 1, 2008. On
November 10, 2008, we entered into a formal compensation agreement with Scott
Hayashi to act as our Interim Chief Financial Officer. The
compensation agreement is retroactively effective as of October 1,
2008. Under the compensation agreement, Mr. Hayashi has agreed to
continue to provide services to the company as a part-time consultant for a
period of three months at a rate of $6,500 per month. Mr. Hayashi is
also eligible for an incentive payment following the sale, license, or financing
of our SEPET assets, the exact amount to be determined in the sole discretion of
the Board after taking into account the timing, size and structure of the
transaction. Although the consulting agreement expired on December
31, 2008, Mr. Hayashi’s agreement was verbally extended on January 1, 2009 on a
month to month basis whereby he is entitled to receive a monthly retainer of
$4,500.
DIRECTOR
COMPENSATION
The
following table sets forth information concerning the compensation paid to each
of our non-employee directors during 2008 for their services rendered as
directors. We do not have a Non-Equity Incentive Plan Compensation or pay our
directors any nonqualified deferred compensation.
Name
|
|
Fees
Earned or Paid in Cash
|
|
|
Stock
Awards(1)
|
|
|
Option
Awards(2)
|
|
|
All
Other Compensation
|
|
|
Total
|
|
John
M.Vierling, M.D., FACP(3)
|
|
|
- |
|
|
$ |
16,859 |
|
|
$ |
7,871 |
|
|
|
- |
|
|
$ |
24,731 |
|
Jack
E. Stover(4)
|
|
|
- |
|
|
$ |
16,859 |
|
|
$ |
7,871 |
|
|
|
- |
|
|
$ |
24,731 |
|
Thomas
C. Seoh(5)
|
|
|
- |
|
|
$ |
9.078 |
|
|
$ |
7,871 |
|
|
|
- |
|
|
$ |
16,950 |
|
Thomas
M. Tully(6)
|
|
|
- |
|
|
$ |
9,078 |
|
|
$ |
7,871 |
|
|
|
- |
|
|
$ |
16,950 |
|
Dennis
Kogod(7)
|
|
|
- |
|
|
$ |
3,891 |
|
|
$ |
7,871 |
|
|
|
- |
|
|
$ |
11,762 |
|
Amy
Factor(8)
|
|
$ |
80,000 |
|
|
$ |
24,500 |
|
|
$ |
7,871 |
|
|
|
- |
|
|
$ |
112,371 |
|
1.
|
Represents
the compensation expense incurred by us in 2008 in connection with awards
of restricted stock to the director, calculated in accordance with
SFAS 123R, disregarding the estimate of forfeitures for service-based
vesting conditions,
and thus includes amounts from awards in and prior to 2008. See
our audited consolidated financial statements included elsewhere in this
Annual Report for details as to the assumptions used to determine the fair
value of the restricted stock awards. Our directors will not
realize the value of these awards in cash until these awards are fully
vested and the shares are subsequently
sold.
|
2.
|
Represents
the compensation expense incurred by us in 2008 in connection with option
grants to the director, calculated in accordance with SFAS 123R,
disregarding the estimate of forfeitures for service-based vesting
conditions, and thus includes amounts from awards in and prior to
2008. See our audited consolidated financial statements
included elsewhere in this Annual Report for details as to the assumptions
used to determine the fair value of the option awards. Amounts include
aggregate charge to financial statements. Our directors will
not realize the value of these awards in cash until these awards are
exercised and the underlying shares are subsequently sold. All
options awarded to Directors in 2008 remained outstanding at fiscal
year-end.
|
3.
|
As
of December 31, 2008, the last day of our fiscal year, there are
outstanding 67,188 shares of restricted stock, all of which are vested,
and options for the purchase of 215,957 shares of common stock, all of
which are vested, issued to John M. Vierling, M.D., FACP. During 2008, Dr.
Vierling received options to purchase 15,000 shares of common stock with a
grant date fair value of $7,871.
|
4.
|
As
of December 31, 2008, the last day of our fiscal year, there are
outstanding 67,188 shares of restricted stock, all of which are vested,
and options for the purchase of 129,957 shares of common stock, all of
which are vested, issued to Jack E. Stover. During 2008, Mr.
Stover received options to purchase 15,000 shares of common stock with a
grant date fair value of $7,871.
|
5.
|
As
of December 31, 2008, the last day of our fiscal year, there are
outstanding 36,719 shares of restricted stock, all of which are vested,
and options for the purchase of 120,356 shares of common stock, all of
which are vested, issued to Thomas C. Seoh. During 2008, Mr. Seoh received
options to purchase 15,000 shares of common stock with a grant date fair
value of $7,871.
|
6.
|
As
of December 31, 2008, the last day of our fiscal year, there are
outstanding 36,719 shares of restricted stock, all of which are vested,
and options for the purchase of 133,613 shares of common stock, all of
which are vested, issued to Thomas M. Tully. During 2008, Mr.
Tully received options to purchase 15,000 shares of common stock with a
grant date fair value of $7,871.
|
7.
|
As
of December 31, 2008, the last day of our fiscal year, there are
outstanding 31,650 shares of restricted stock, all of which are vested,
and options for the purchase of 102,794 shares of common stock, all of
which are vested, issued to Dennis Kogod. During 2008, Mr.
Kogod received options to purchase 15,000 shares of common stock with a
grant date fair value of $7,871.
|
8.
|
As
of December 31, 2008, the last day of our fiscal year, there are
outstanding 169,118 shares of restricted stock, 144,118 of which are
vested, options for the purchase of 527,500 shares of common stock, all of
which are vested, issued to Amy Factor, and warrants to purchase 300,000
shares of common stock. In October 2008, 100,000 warrant shares
were canceled due to the expiration of the extended
term. During 2008, Ms. Factor received (1) cash compensation of
$80,000 and (2) a restricted stock grant of 25,000 shares of common stock
with a grant date fair value of $16,000 for services rendered as a
director and Vice Chairman of the Company, and (3) options to purchase
15,000 shares of common stock with a grant date fair value of
$7,871. In June 2008, the restricted stock grant of 25,000
shares of common stock was canceled due to not meeting the prescribed
milestone.
|
Compensation
of Board of Directors
Equity
Compensation
On March
24, 2005, the Board of Directors approved a plan for compensating our
directors. On May 16, 2005, the Board of Directors amended the plan
for the 2005 fiscal year and later renewed the plan on January 11, 2006. The
plan consists of the following:
Non-employee
directors will receive annual grants of stock options to purchase 15,000 shares
of our 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 our 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 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.
On June
30, 2006, the Board of Directors resolved to suspend cash compensation discussed
below for independent members and to issue restricted stock instead to help us
maintain our cash reserves.
Cash
Compensation
Effective
March 24, 2005, all non-employee directors were paid $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 of Directors 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 would receive $25,000 annually (payable quarterly), and the
Chairman of the Nomination Committee and the Chairman of the Compensation
Committee would receive $10,000 annually (payable
quarterly). Effective June 30, 2006, this policy was amended and we
terminated all cash compensation payments to non-employee directors and issued
equivalent amounts of restricted stock in lieu of cash
compensation. We reimburse all directors for any expenses incurred by
them in attending meetings of the Board of Directors.
Compensation
in 2008
During
the fiscal year ended December 31, 2008, 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 $0.69 per share. All director options were granted
at the market price on the date of grant and have a term of seven years and vest
on a monthly basis for a period of one year from the date of
grant. In January 2008, a director received a restricted stock grant
of 25,000 shares of common stock and cash compensation of $80,000 for additional
consulting services rendered to the Company. The restricted stock
grant was canceled in June 2008 due to not meeting the prescribed
milestone.
Security
Ownership of Certain Beneficial Owners
The
following table sets forth certain information regarding beneficial ownership of
our common stock as of March 31, 2009 (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, (c) by each of our directors and (d) by all of our
current executive officers and directors as a group. As of March 31,
2009 there were 24,356,247 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 Arbios Systems, Inc. at 200 E. Del Mar Blvd.,
Suite 320, Pasadena, CA 91105.
If the
Plan is confirmed, all of the outstanding shares of our common stock, and all of
the options and warrants will be canceled. Under the Plan, each
current stockholder will receive one share of new common stock for each ten (10)
shares that such stockholder currently owns (effectively, a 1-for-10 reverse
stock split). As a result of the recapitalization to be effected
under the Plan, the security ownership of the persons listed below will be
substantially changed and reduced as follows: (i) All of the issued
shares will be reduced by the 1-for-10 share cancellation and issuance; and (ii)
all options and warrants owned by the below security holders will be
canceled. Therefore, while the total number of shares outstanding
after the Bankruptcy will remain the same, the number of shares beneficially
owned, and the percentage of each of the security holders listed below will be
substantially less after the Bankruptcy.
Name
and Address of Beneficial Owner
|
|
Shares
Beneficially
Owned
(1)
|
|
|
Percentage
of Class
|
|
Jacek
Rozga, M.D., Ph.D.
|
|
|
2,050,000 |
(2) |
|
|
8.4 |
% |
Achilles
A. Demetriou, M.D., Ph.D and Kristin P. Demetriou
|
|
|
2,500,000 |
(3) |
|
|
10.3 |
% |
John
M. Vierling, M.D., FACP
|
|
|
283,145 |
(4) |
|
|
1.2 |
% |
Amy
Factor
|
|
|
986,618 |
(5) |
|
|
3.9 |
% |
Jack
E. Stover
|
|
|
198,145 |
(6) |
|
|
* |
|
Thomas
C. Seoh
|
|
|
157,075 |
(7) |
|
|
* |
|
Dennis
Kogod
|
|
|
144,444 |
(8) |
|
|
* |
|
Thomas
Tully
|
|
|
170,332 |
(9) |
|
|
* |
|
Scott
L. Hayashi
|
|
|
154,855 |
(10) |
|
|
* |
|
Shawn
Cain
|
|
|
186,250 |
(11) |
|
|
* |
|
LibertyView
Funds, LP
111
River Street – Suite 1000
Hoboken,
NJ 07030-5776
|
|
|
1,851,488 |
(12) |
|
|
7.4 |
% |
LibertyView
Special Opportunities Fund, LP
111
River Street – Suite 1000
Hoboken,
NJ 07030-5776
|
|
|
2,331,008 |
(13) |
|
|
9.2 |
% |
Neuberger
Berman LLC
111
River Street – Suite 1000
Hoboken,
NJ 07030-5776
|
|
|
4,842,428 |
(14) |
|
|
18.5 |
% |
Dolphin
Offshore Partners, LP
129
East 17th
Street
New
York, New York 10003
|
|
|
2,000,000 |
(15) |
|
|
7.9 |
% |
All
current executive officers and directors as a
group
(8 persons)
|
|
|
2,280,864 |
(16) |
|
|
9.0 |
% |
(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)
|
Consists
of (i) 2,050,000 shares of common stock owned by Jacek Rozga and Joanna
Rozga JTTEN.
|
(3)
|
Consists
of 2,500,000 shares of common stock 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 (i) 67,188 shares of common stock and (ii) currently exercisable
options to purchase 215,957 shares of common
stock.
|
(5)
|
Consists
of (i) currently exercisable options to purchase 527,500 shares of common
stock, (ii) warrants to purchase 200,000 shares exercisable by AFO
Advisors, LLC (iii) 5,000 shares owned by the Jay H. Oyer and Amy Factor
Foundation, (iv) 5,000 shares owned by the Melissa H. Oyer Trust, (v)
5,000 shares owned by the Zachary D. Oyer Trust, (vi) 100,000 shares owned
by AFO Capital Advisors, LLC (vii) 100,000 shares of restricted common
stock owned by AFO Advisors LLC, and (viii) 44,118 shares of common
stock. 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.
|
(6)
|
Consists
of (i) 68,188 shares of common stock and (ii) currently exercisable
options to purchase 129,957 shares of common
stock.
|
(7)
|
Consists
of (i) 36,719 shares of common stock and (ii) currently exercisable
options to purchase 120,356 shares of common
stock.
|
(8)
|
Consists
of (i) 41,650 shares of common stock and (ii) currently exercisable
options to purchase 102,794 shares of common
stock.
|
(9)
|
Consists
of (i) 36,719 shares of common stock and (ii) currently exercisable
options to purchase 133,613 shares of common
stock.
|
(10)
|
Consists
of (i) 4,615 shares of common stock owned by Hannah Hayashi, Scott
Hayashi’s wife, (ii) 3,000 shares of common stock owned by Scott Hayashi,
(iii) currently exercisable options held by Scott Hayashi to purchase
142,625 shares of common stock and (iv) warrants to purchase 4,615 shares
of common registered in the name of Hannah
Hayashi.
|
(11)
|
Consists
of currently exercisable options to purchase 186,250 shares of common
stock.
|
(12)
|
Consists
of (i) 1,185,243 shares of common stock and (ii) currently exercisable
warrants to purchase 666,245 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 these stockholders 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) 1,424,912 shares of common stock and (ii) currently exercisable
warrants to purchase 906,096 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 LibertyView Funds, LP and LibertyView
Special Opportunities Fund, LP (see footnotes 14 and 15). Also
includes (i) 432,843 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 213,238 shares of common stock held by
Trust D for a Portion of the Assets of the Kodak Retirement Income Plan
and (iii) 13,851 shares of common stock held by LibertyView Health
Sciences Fund, LP. 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
warrants to purchase 1,000,000 shares of common
stock.
|
(16)
|
Consists
of the shares of common stock and options set forth in footnotes 4 through
11.
|
Equity
Compensation Plan Information
The
following table summarizes as of December 31, 2008, 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. All of the
options and warrants listed below will be cancelled if the Plan is confirmed by
the Bankruptcy Court.
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)
|
|
|
2,502,495 |
|
|
$ |
1.62 |
|
|
|
2,497,505 |
|
Equity
compensation plans not approved by security holders
|
|
|
700,000 |
(2) |
|
$ |
1.77 |
|
|
|
-0- |
|
Total
|
|
|
3,202,495 |
(3) |
|
$ |
1.66 |
|
|
|
2,497,505 |
|
(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.
(3) Includes
restricted stock grants totaling 421,818 shares of common stock.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Audit
Fees
The
aggregate fees we paid Stonefield Josephson, Inc. during the fiscal year ended
December 31, 2008 and 2007 for professional services for the audit of our
financial statements and the review of financial statements included in our
Quarterly Reports on Forms 10-Q and our other SEC filings were $80,716 and
$99,106, respectively.
Audit-Related
Fees
Stonefield
Josephson, Inc. did not provide, did not bill and was not paid any fees for,
audit-related services in the fiscal years ended December 31, 2008 and
2007.
Tax
Fees
Stonefield
Josephson, Inc. did not provide, did not bill and was not paid any fees for, tax
compliance, tax advice, and tax planning services for the fiscal years ended
December 31, 2008 and 2007.
All
Other Fees
Stonefield
Josephson, Inc. did not provide, did not bill and was not paid any fees for, any
other services in the fiscal years ended December 31, 2008 and
2007.
Audit
Committee Pre-Approval Policies and Procedures
Consistent
with SEC policies, the Audit Committee charter provides that the Audit Committee
shall pre-approve all audit engagement fees and terms and pre-approve any other
significant compensation to be paid to the independent registered public
accounting firm. The Audit Committee pre-approved all services
performed by Stonefield Josephson, Inc. during 2008 and 2007.
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
The
following exhibits are filed as part of this report:
Exhibit
Number
|
|
Description
|
2.1
|
|
Agreement
and Plan of Reorganization, dated October 20, 2003, by and among
Historical Autographs U.S.A., Inc., Arbios Technologies, Inc., HAUSA
Acquisition, Inc., Cindy K. Swank and Raymond J. Kuh
(1)
|
|
|
|
2.2+
|
|
Debtor
In Possession’s Application For An Order Conditionally Approving The Plan
As The Disclosure Statement, filed by Arbios Systems, Inc. on April 3,
2009 in the United States Bankruptcy Court For The District Of Delaware
pursuant to the provisions of Chapter 11 of the Bankruptcy
Code
|
|
|
|
3.1
|
|
Certificate
of Incorporation of Arbios Systems, Inc. dated June 3, 2005
(7)
|
|
|
|
3.2
|
|
Certificate
of Correction of Arbios Systems, Inc. dated on July 6, 2005
(7)
|
|
|
|
3.3
|
|
Certificate
of Ownership and Merger dated July 25, 2005 (7)
|
|
|
|
3.4
|
|
Certificate
of Ownership and Merger dated July 26, 2005 (7)
|
|
|
|
3.5
|
|
Bylaws
of Arbios Systems, Inc. (7)
|
|
|
|
4.1
|
|
Form
of Common Stock certificate (7)
|
|
|
|
4.2
|
|
Form
of Common Stock Purchase Warrant
(3)
|
4.3
|
|
Common
Stock Purchase Warrant dated April 1, 2004 (4)
|
|
|
|
4.4
|
|
Form
of Warrant to Purchase Common Stock dated January 11, 2005
(5)
|
|
|
|
4.5
|
|
Common
Stock Purchase Warrant dated March 29, 2007 (8)
|
|
|
|
10.1*
|
|
2001
Stock Option Plan (2)
|
|
|
|
10.2
|
|
License
Agreement, entered into as of June 2001, by and between Cedars-Sinai
Medical Center and Arbios Technologies, Inc. (3)
|
|
|
|
10.3
|
|
License
Agreement, dated December 26, 2001, by and between Spectrum Laboratories,
Inc. and Arbios Technologies, Inc. (3)
|
|
|
|
10.4
|
|
Asset
Purchase Agreement among Circe Biomedical, Inc., Arbios Technologies,
Inc., and Arbios Systems, Inc., dated as of April 7, 2004
(4)
|
|
|
|
10.5
|
|
Manufacturing
and Supply Agreement, dated as of December 26, 2001, between Spectrum
Laboratories, Inc. and Arbios Technologies, Inc. (4)
|
|
|
|
10.6
|
|
Research
Agreement, dated as of December 26, 2001, between Spectrum Laboratories,
Inc. and Arbios Technologies, Inc. (4)
|
|
|
|
10.7
|
|
First
Amendment to Research Agreement, dated as of October 14, 2002, between
Spectrum Laboratories, Inc. and Arbios Technologies, Inc.
(4)
|
|
|
|
10.8
|
|
Form
of Purchase Agreement, dated as of January 11, 2005, by and among Arbios
Systems, Inc. and the Investors named therein (5)
|
|
|
|
10.9
|
|
Form
of Registration Rights Agreement, dated as of January 11, 2005, by and
among Arbios Systems, Inc. and the Investors named therein
(5)
|
|
|
|
10.10
|
|
Omnibus
Stockholders’ Agreement, dated as of October 24, 2003, by and among Arbios
Technologies, Inc., Historical Autographs U.S.A., Inc., Spectrum
Laboratories, Inc., Cedars-Sinai Medical Center, Achilles A. Demetriou,
M.D., Ph.D. and Kristin P. Demetriou, as Trustees of the A & K
Demetriou Family Trust created on November 13, 2000, and Jacek Rozga,
M.D., Ph.D. and Joanna Rozga(18)
|
|
|
|
10.11*
|
|
Employment
Offer Letter, dated March 25, 2005, between Arbios Systems, Inc. and Shawn
Cain (7)
|
|
|
|
10.12*
|
|
Employment
Offer Letter, dated March 29, 2005, between Arbios Systems, Inc. and Scott
Hayashi (7)
|
|
|
|
10.13*
|
|
2005
Stock Incentive Plan (6)
|
|
|
|
10.14*
|
|
Form
of Stock Option Agreement for the 2005 Stock Incentive Plan
(6)
|
|
|
|
10.15
|
|
License
Agreement, dated March 29, 2007, between Arbios Systems, Inc. and
Immunocept, LLC (8) (12)
|
10.16
|
|
Purchase
Agreement, dated April 23, 2007, by and among Arbios Systems, Inc. and the
Investors set forth on the signature pages affixed thereto
(9).
|
|
|
|
10.17
|
|
Registration
Rights Agreement, dated April 23, 2007, by and among Arbios Systems, Inc.
and the Investors named herein (9).
|
|
|
|
10.18
|
|
Form
of Warrant A to Purchase Common Stock dated April 23, 2007
(9)
|
|
|
|
10.19
|
|
Form
of Warrant B to Purchase Common Stock dated April 23, 2007
(9)
|
|
|
|
10.20
|
|
Offer
Letter of Dr. Jacek Rozga dated April 26, 2007 (10)
|
|
|
|
10.21
|
|
Certificate
of Amendment of Certificate of Incorporation of Arbios Systems, Inc. dated
July 13, 2007 (11)
|
|
|
|
10.22
|
|
Supply
Agreement by and between Membrana GmbH and Arbios Systems, Inc. dated
September 14, 2007 (11)
|
|
|
|
10.23
|
|
Lease
Agreement by and between Cummings Properties, LLC and Arbios Systems, Inc.
dated September 15, 2007 (11)
|
|
|
|
10.24
|
|
Consulting
Agreement by and between David Zeffren and Arbios Systems, Inc. dated
November 8, 2007 (11)
|
|
|
|
10.25
|
|
Separation
Agreement by and between Walter C. Ogier and Arbios Systems, Inc. dated
November 13, 2007 (11)
|
|
|
|
10.26
|
|
Manufacturing
& Supply Agreement by and between NxStage Medical, Inc. and Arbios
Systems, Inc. dated October 19, 2007 (12)(18).
|
|
|
|
10.27*
|
|
Consulting
Agreement, dated August 1, 2008, between the Company and Shawn P. Cain
(15)
|
|
|
|
10.28*
|
|
Consulting
Agreement, dated August 1, 2008, between the Company and Scott Hayashi
(15)
|
|
|
|
10.29
|
|
Asset
Purchase Agreement, dated October 3, 2008, between Arbios Systems, Inc,
and HepaLife Technologies, Inc. (16)
|
|
|
|
10.30*
|
|
Compensation
Agreement between Arbios Systems, Inc. and Shawn Cain
(16)
|
|
|
|
10.31*
|
|
Compensation
Agreement between Scott Hayashi and Arbios Systems, Inc., dated November
10, 2008 (17)
|
|
|
|
31.1+
|
|
Certification
of Principal Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
|
|
31.2+
|
|
Certification
of Principal Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
|
|
32.1+
|
|
Certification
of Principal Executive Officer Pursuant to 18 U.S.C. Section
1350
|
|
|
|
32.2+
|
|
Certification
of Principal Financial Officer Pursuant to 18 U.S.C. Section
1350
|
*
|
Denotes
a management contract or compensatory plan or
arrangement.
|
(1)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 14, 2003, which exhibit
is hereby incorporated herein by
reference.
|
(2)
|
Previously
filed as an exhibit to the Company’s Registration Statement on Form 10-SB
filed with the Securities and Exchange Commission on April 26, 2001, which
exhibit is hereby incorporated herein by
reference.
|
(3)
|
Previously
filed as an exhibit to the Company’s Annual Report on Form 10-KSB filed
with the Securities and Exchange Commission on March 30, 2004, which
exhibit is hereby incorporated herein by
reference.
|
(4)
|
Previously
filed as an exhibit to the Company’s Registration Statement on Form SB-2/A
filed with the Securities and Exchange Commission on September 10, 2004,
which exhibit is hereby incorporated herein by
reference.
|
(5)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on January 14, 2005, which exhibit
is hereby incorporated herein by
reference.
|
(6)
|
Previously
filed as an exhibit to the Company’s Quarterly Report on Form S-8 filed
with the Securities and Exchange Commission on August 31, 2005, which
exhibit is hereby incorporated herein by
reference.
|
(7)
|
Previously
filed as an exhibit to the Company’s Form 10-KSB filed with the Securities
and Exchange Commission on March 31, 2006, which exhibit is hereby
incorporated herein by reference.
|
(8)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on April 4,
2007.
|
(9)
|
Previously
filed as the corresponding exhibit to the Company’s Current Report on Form
8-K filed with the Securities and Exchange Commission on April 27, 2007,
which exhibit is hereby incorporate herein by
reference.
|
(10)
|
Previously
filed as the corresponding exhibit to the Company’s Current Report on Form
8-K filed with the Securities and Exchange Commission on May 3, 2007,
which exhibit is hereby incorporate herein by
reference.
|
(11)
|
Previously
filed as an exhibit to the Company’s Form 10-QSB filed with the Securities
and Exchange Commission on November 14,
2007.
|
(12)
|
Portions
of this exhibit have been omitted and filed separately with the Secretary
of the Securities and Exchange Commission pursuant to a confidential
treatment request.
|
(13)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on February 15,
2008.
|
(14)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on May 12,
2008.
|
(15)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on August 6,
2008.
|
(16)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on October 7,
2008.
|
(17)
|
Previously
filed as an exhibit to the Company’s Form 10-Q filed with the Securities
and Exchange Commission on November 14, 2008, which exhibit is hereby
incorporated herein by reference.
|
(18)
|
Previously
filed as an exhibit to the Company’s Annual Report on Form 10-KSB filed
with the Securities and Exchange Commission on March 31, 2008, which
exhibit is hereby incorporated herein by
reference.
|
ADDITIONAL
INFORMATION
We are
subject to the informational requirements of the Exchange Act and, in accordance
with the rules and regulations of the Securities and Exchange Commission; we
file reports, proxy statements and other information. You may read
and copy any document we file with the SEC at the SEC’s Public Reference Room at
100 F Street, N.E., Washington, D.C. 20549. You can request copies of these
documents by writing to the SEC and paying a fee for the copying cost. Please
call the SEC at 1-800-SEC-0330 for more information about the operation of the
SEC’s Public Reference Room. Our SEC filings are also available to the public at
the SEC’s web site at http://www.sec.gov.
INDEX
TO FINANCIAL STATEMENTS
Independent
Registered Public Accounting Firm Report
|
|
F-1
|
Balance
Sheet - As of December 31, 2008 and 2007
|
|
F-2
|
Statement
of Operations - For the Years Ended December 31, 2008,
2007
|
|
|
and
Period From August 23, 2000 (Inception) to December 31,
2008
|
|
F-3
|
Statement
of Cash Flows - For the Years Ended December 31, 2008,
2007
|
|
|
and
Period From August 23, 2000 (Inception) to December 31,
2008
|
|
F-4
|
Statements
of Change in Stockholders’ Equity - For the Years Ended
|
|
|
December 31,
2008, 2007 and Period From August 23, 2000 (Inception) to December 31,
2008
|
|
F-5
|
Notes
to Financial Statements
|
|
F-10
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of
Directors
Arbios
Systems, Inc.
Pasadena,
California
We have
audited the accompanying balance sheets of Arbios Systems, Inc. (a development
stage enterprise) as of December 31, 2008 and 2007 and the related statements of
operations, stockholders’ equity and cash flows for each of the two years in the
period ended December 31, 2008 and 2007 and the period from August 23, 2000
(inception) to December 31, 2008. 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 audits 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. The Company is not
required to have, nor were we engaged to perform, an audit of its 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 financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide 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, 2008 and 2007 and the results of its operations and its cash flows for each
of the two years in the period ended December 31, 2008 and 2007 and the period
from August 23, 2000 (inception) to December 31, 2008, in conformity with
accounting principles generally accepted in the United States of
America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1 of the
financial statements, the Company has suffered recurring losses from operations
including a net loss of $2,273,501 for the year ended December 31, 2008 and has
an accumulated deficit of $21,588,473 as of December 31, 2008, and has been
dependent solely on obtaining outside equity to finance
operations. On January 9, 2009, the Company filed a voluntary
petition for relief (the “Bankruptcy Filing”) under Chapter 11 of the United
States Bankruptcy Code in the United States Bankruptcy Court for the District of
Delaware (the “Bankruptcy Court”). All of which raise
substantial doubt about the Company’s ability to continue as a going
concern. Management’s plans in regard to these matters are also
described in Note 1. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
/s/
Stonefield Josephson, Inc.
Los
Angeles, California
April 15,
2009
ARBIOS
SYSTEMS, INC.
(A
development stage company)
BALANCE
SHEETS
December
31, 2008 and 2007
|
|
December
31,
|
|
|
|
2008
|
|
|
2007
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
370,686 |
|
|
$ |
2,735,944 |
|
Prepaid expenses
|
|
|
21,506 |
|
|
|
37,546 |
|
Total current assets
|
|
|
392,192 |
|
|
|
2,773,490 |
|
|
|
|
|
|
|
|
|
|
Receivable
|
|
|
200,000 |
|
|
|
- |
|
Net
property and equipment
|
|
|
6,177 |
|
|
|
45,450 |
|
Investment
|
|
|
86,209 |
|
|
|
- |
|
Patent
rights, net of accumulated amortization of $0 and $134,374,
respectively
|
|
|
- |
|
|
|
132,293 |
|
Other
assets
|
|
|
750 |
|
|
|
86,993 |
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
685,328 |
|
|
$ |
3,038,226 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
194,046 |
|
|
$ |
434,727 |
|
Accrued expenses
|
|
|
286,888 |
|
|
|
483,617 |
|
Total current liabilities
|
|
|
480,934 |
|
|
|
918,344 |
|
|
|
|
|
|
|
|
|
|
Long
term contract obligations
|
|
|
150,000 |
|
|
|
250,000 |
|
Total liabilities
|
|
|
630,934 |
|
|
|
1,168,344 |
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
|
Preferred stock, $.001 par value; 5,000,000 shares
authorized:
|
|
|
|
|
|
|
|
|
none issued and outstanding
|
|
|
- |
|
|
|
- |
|
Common
stock, $.001 par value; 100,000,000 and 60,000,000 shares authorized;
25,792,747
|
|
|
|
|
|
|
|
|
and 25,578,461 shares issued and outstanding at December
31, 2008 and 2007, respectively
|
|
|
25,792 |
|
|
|
25,578 |
|
Additional
paid-in capital
|
|
|
21,617,075 |
|
|
|
21,159,276 |
|
Deficit accumulated during the development stage
|
|
|
(21,588,473 |
) |
|
|
(19,314,972 |
) |
Total
stockholders' equity
|
|
|
54,394 |
|
|
|
1,869,882 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
|
$ |
685,328 |
|
|
$ |
3,038,226 |
|
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
to
December
31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
Revenues
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
320,966 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
1,499,914 |
|
|
|
3,420,048 |
|
|
|
13,242,051 |
|
Research
and development
|
|
|
1,212,824 |
|
|
|
2,299,632 |
|
|
|
9,325,632 |
|
Total
operating expenses
|
|
|
2,712,738 |
|
|
|
5,719,680 |
|
|
|
22,567,683 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before other income (expense)
|
|
|
(2,712,738 |
) |
|
|
(5,719,680 |
) |
|
|
(22,246,717 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
34,374 |
|
|
|
167,030 |
|
|
|
497,519 |
|
Gain
on Sale of HepatAssist program (net)
|
|
|
404,863 |
|
|
|
- |
|
|
|
404,863 |
|
Interest
expense
|
|
|
- |
|
|
|
- |
|
|
|
(244,138 |
) |
Total
other income
|
|
|
439,237 |
|
|
|
167,030 |
|
|
|
658,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(2,273,501 |
) |
|
$ |
(5,552,650 |
) |
|
$ |
(21,588,473 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$ |
(0.09 |
) |
|
$ |
(0.24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
|
25,733,432 |
|
|
|
22,918,181 |
|
|
|
|
|
The
accompanying notes are an integral part of these financial
statements.
ARBIOS
SYSTEMS, INC.
(A
Development Stage Company)
STATEMENTS
OF CASH FLOWS
|
|
For
the year ended December 31,
|
|
|
Inception
to
December
31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(2,273,501 |
) |
|
$ |
(5,552,650 |
) |
|
$ |
(21,588,473 |
) |
Adjustments
to reconcile net loss to net cash
|
|
|
|
|
|
|
|
|
|
|
|
|
used
in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization
of debt discount
|
|
|
- |
|
|
|
- |
|
|
|
244,795 |
|
Depreciation
and amortization
|
|
|
33,773 |
|
|
|
50,045 |
|
|
|
336,037 |
|
Patent
rights impairment
|
|
|
- |
|
|
|
- |
|
|
|
91,694 |
|
Issuance
of common stock, options and warrants for compensation
|
|
|
458,013 |
|
|
|
813,513 |
|
|
|
4,071,460 |
|
Issuance
of warrants for patent acquistion
|
|
|
- |
|
|
|
74,570 |
|
|
|
74,570 |
|
Settlement
of accrued expense
|
|
|
- |
|
|
|
- |
|
|
|
54,401 |
|
Deferred
compensation costs
|
|
|
- |
|
|
|
- |
|
|
|
319,553 |
|
Loss
on disposition of fixed assets
|
|
|
2,271 |
|
|
|
2,766 |
|
|
|
5,037 |
|
Gain
on sale of HepatAssist program
|
|
|
(404,863 |
) |
|
|
- |
|
|
|
(404,863 |
) |
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
16,040 |
|
|
|
109,617 |
|
|
|
(21,508 |
) |
Other
assets
|
|
|
86,243 |
|
|
|
(24,166 |
) |
|
|
(750 |
) |
Accounts
payable
|
|
|
(240,681 |
) |
|
|
124,565 |
|
|
|
194,046 |
|
Accrued
expenses
|
|
|
(196,729 |
) |
|
|
351,544 |
|
|
|
193,386 |
|
Other
liabilities
|
|
|
- |
|
|
|
- |
|
|
|
64,695 |
|
Contractual
obligation
|
|
|
(100,000 |
) |
|
|
250,000 |
|
|
|
150,000 |
|
Net
cash used in operating activities
|
|
|
(2,619,434 |
) |
|
|
(3,800,196 |
) |
|
|
(16,215,920 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions
of property and equipment
|
|
|
- |
|
|
|
(4,671 |
) |
|
|
(149,467 |
) |
Proceeds
from sale of fixed assets
|
|
|
4,176 |
|
|
|
- |
|
|
|
4,176 |
|
Proceeds
from sale of HepatAssist program
|
|
|
250,000 |
|
|
|
- |
|
|
|
250,000 |
|
Purchase
of short term investments
|
|
|
- |
|
|
|
- |
|
|
|
(21,866,787 |
) |
Maturities
of short term investments
|
|
|
- |
|
|
|
- |
|
|
|
21,866,787 |
|
Net cash provided from (used in) investing activities
|
|
|
254,175 |
|
|
|
(4,671 |
) |
|
|
104,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of convertible debt
|
|
|
- |
|
|
|
- |
|
|
|
400,000 |
|
Proceeds
from common stock option/warrant exercise
|
|
|
- |
|
|
|
2,700 |
|
|
|
67,900 |
|
Net
proceeds from issuance of common stock and warrants
|
|
|
- |
|
|
|
4,483,831 |
|
|
|
15,797,080 |
|
Net
proceeds from issuance of preferred stock
|
|
|
- |
|
|
|
- |
|
|
|
238,732 |
|
Payments
on capital lease obligation, net
|
|
|
- |
|
|
|
- |
|
|
|
(21,815 |
) |
Net
cash provided by financing activities
|
|
|
- |
|
|
|
4,486,531 |
|
|
|
16,481,897 |
|
Net
(decrease) increase in cash
|
|
|
(2,365,258 |
) |
|
|
681,664 |
|
|
|
370,686 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
at beginning of period
|
|
|
2,735,944 |
|
|
|
2,054,280 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
at end of period
|
|
$ |
370,686 |
|
|
$ |
2,735,944 |
|
|
$ |
370,686 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosures of non-cash financing activity
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of securities for obligation related to finder’s fees
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
47,500 |
|
HepaLife
warrant and receivable
|
|
$ |
286,209 |
|
|
$ |
- |
|
|
$ |
286,209 |
|
The
accompanying notes are an integral part of these financial
statements.
ARBIOS
SYSTEMS, INC.
(A
Development Stage Company)
STATEMENT
OF STOCKHOLDERS’ EQUITY
PERIOD
FROM AUGUST 23, 2000 (INCEPTION) TO DECEMBER 31, 2008
|
|
Preferred
Stock
|
|
|
Common
Stock
|
|
|
Additional
Paid-In
|
|
|
Deferred
|
|
|
Deficit
Accumulated
During
the Development
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Costs
|
|
|
Stage
|
|
|
Total
|
|
Balance,
August 23, 2000 (inception) restated for effect of reverse merger with
Historical Autographs U.S.A. Inc.
|
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
issuance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
in
exchange for cash
|
|
|
|
|
|
|
|
|
|
|
5,000,000 |
|
|
|
50 |
|
|
|
4,950 |
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,454 |
) |
|
|
(9,454 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2000,
as restated
|
|
|
- |
|
|
|
- |
|
|
|
5,000,000 |
|
|
|
50 |
|
|
|
4,950 |
|
|
|
- |
|
|
|
(9,454 |
) |
|
|
(4,454 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of junior preferred stock for cash of $250,000 and in exchange for
$400,000 in patent rights, research and development costs, and employee
loanout costs less issuance expenses of $11,268, June 29,
2001
|
|
|
681,818 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
958,278 |
|
|
|
(343,553 |
) |
|
|
|
|
|
|
614,732 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock in exchange for patent rights and deferred research and
development costs
|
|
|
|
|
|
|
|
|
|
|
362,669 |
|
|
|
4 |
|
|
|
547,284 |
|
|
|
|
|
|
|
|
|
|
|
547,288 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Services
receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(550,000 |
) |
|
|
|
|
|
|
(550,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
employee loan-out costs receivable earned
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
82,888 |
|
|
|
|
|
|
|
82,888 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(237,574 |
) |
|
|
(237,574 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2001
|
|
|
681,818 |
|
|
|
7 |
|
|
|
5,362,669 |
|
|
|
54 |
|
|
|
1,510,512 |
|
|
|
(810,665 |
) |
|
|
(247,028 |
) |
|
|
452,880 |
|
The
accompanying notes are an integral part of these financial
statements.
ARBIOS
SYSTEMS, INC.
(A
Development Stage Company)
STATEMENT
OF STOCKHOLDERS’ EQUITY
PERIOD
FROM AUGUST 23, 2000 (INCEPTION) TO DECEMBER 31, 2008
|
|
Preferred
Stock
|
|
|
Common
Stock
|
|
|
Additional
Paid-In
|
|
|
Deferred
|
|
|
Deficit
Accumulated
During
the Development
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Costs
|
|
|
Stage
|
|
|
Total
|
|
Amendment
of December 31, 2001 agreement for the issuance of common stock agreement
in exchange for research and development services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(495,599 |
) |
|
|
550,000 |
|
|
|
|
|
|
54,401 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
employee loan out costs receivable earned
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
171,776 |
|
|
|
|
|
|
171,776 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock for compensation
|
|
|
|
|
|
|
|
|
70,000 |
|
|
|
1 |
|
|
|
10,499 |
|
|
|
|
|
|
|
|
|
|
10,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock for cash
|
|
|
|
|
|
|
|
|
999,111 |
|
|
|
9 |
|
|
|
149,857 |
|
|
|
|
|
|
|
|
|
|
149,866 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(494,780 |
) |
|
|
(494,780 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2002
|
|
|
681,818 |
|
|
|
7 |
|
|
|
6,431,780 |
|
|
|
64 |
|
|
|
1,175,269 |
|
|
|
(88,889 |
) |
|
|
(741,808 |
) |
|
|
344,643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock for cash less issuance expense of
$2,956
|
|
|
|
|
|
|
|
|
|
|
417,000 |
|
|
|
417 |
|
|
|
246,827 |
|
|
|
|
|
|
|
|
|
|
|
247,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock in private placement for cash less issuance expense of
$519,230
|
|
|
|
|
|
|
|
|
|
|
4,000,000 |
|
|
|
4,000 |
|
|
|
3,476,770 |
|
|
|
|
|
|
|
|
|
|
|
3,480,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock for convertible debenture less issuance expense of
$49,500
|
|
|
|
|
|
|
|
|
|
|
400,000 |
|
|
|
400 |
|
|
|
350,100 |
|
|
|
|
|
|
|
|
|
|
|
350,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
issued in connection with acquisition of Historical Autographs U.S.A.,
Inc. on October 30, 2003
|
|
|
|
|
|
|
|
|
|
|
1,220,000 |
|
|
|
8,263 |
|
|
|
(8,263 |
) |
|
|
|
|
|
|
|
|
|
|
- |
|
The
accompanying notes are an integral part of these financial
statements.
ARBIOS
SYSTEMS, INC.
(A
Development Stage Company)
STATEMENT
OF STOCKHOLDERS’ EQUITY
PERIOD
FROM AUGUST 23, 2000 (INCEPTION) TO DECEMBER 31, 2008
|
|
Preferred
Stock
|
|
|
Common
Stock
|
|
|
Additional
Paid-In
|
|
|
Deferred
|
|
|
Deficit
Accumulated
During
the Development
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Costs
|
|
|
Stage
|
|
|
Total
|
|
Value
of warrants and beneficial conversion feature of bridge
loan
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
244,795 |
|
|
|
|
|
|
|
|
|
244,795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
employee loan-out costs receivable earned
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88,889 |
|
|
|
|
|
|
88,889 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
Stock converted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
to
Common Stock
|
|
|
(681,818 |
) |
|
|
(7 |
) |
|
|
681,818 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(885,693 |
) |
|
|
(885,693 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2003
|
|
|
- |
|
|
|
- |
|
|
|
13,150,598 |
|
|
|
13,151 |
|
|
|
5,485,498 |
|
|
|
- |
|
|
|
(1,627,501 |
) |
|
|
3,871,148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and
warrants for compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
972,430 |
|
|
|
|
|
|
|
|
|
|
|
972,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise
of common stock options
|
|
|
|
|
|
|
|
|
|
|
18,000 |
|
|
|
18 |
|
|
|
2,682 |
|
|
|
|
|
|
|
|
|
|
|
2,700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of securities for payable
|
|
|
|
|
|
|
|
|
|
|
47,499 |
|
|
|
47 |
|
|
|
47,451 |
|
|
|
|
|
|
|
|
|
|
|
47,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,327,827 |
) |
|
|
(3,327,827 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2004
|
|
|
- |
|
|
|
- |
|
|
|
13,216,097 |
|
|
|
13,216 |
|
|
|
6,508,061 |
|
|
|
- |
|
|
|
(4,955,328 |
) |
|
|
1,565,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock in private
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
placement
for cash less issuance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
expense
of $384,312
|
|
|
|
|
|
|
|
|
|
|
2,991,812 |
|
|
|
2,992 |
|
|
|
6,224,601 |
|
|
|
|
|
|
|
|
|
|
|
6,227,593 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and
warrants for compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
557,080 |
|
|
|
|
|
|
|
|
|
|
|
557,080 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise
of common stock options
|
|
|
|
|
|
|
|
|
|
|
25,000 |
|
|
|
25 |
|
|
|
62,475 |
|
|
|
|
|
|
|
|
|
|
|
62,500 |
|
The
accompanying notes are an integral part of these financial
statements.
ARBIOS
SYSTEMS, INC.
(A
Development Stage Company)
STATEMENT
OF STOCKHOLDERS’ EQUITY
PERIOD
FROM AUGUST 23, 2000 (INCEPTION) TO DECEMBER 31, 2008
|
|
Preferred
Stock
|
|
|
Common
Stock
|
|
|
Additional
Paid-In
|
|
|
Deferred
|
|
|
Accumulated
During the Development
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Costs
|
|
|
Stage
|
|
|
Total
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,823,903 |
) |
|
|
(3,823,903 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2005
|
|
|
- |
|
|
|
- |
|
|
|
16,232,909 |
|
|
|
16,233 |
|
|
|
13,352,217 |
|
|
|
- |
|
|
|
(8,779,231 |
) |
|
|
4,589,219 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock in private
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
placement for cash less issuance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
expense of $95,013
|
|
|
|
|
|
|
|
|
|
|
1,227,272 |
|
|
|
1,227 |
|
|
|
1,253,760 |
|
|
|
|
|
|
|
|
|
|
|
1,254,987 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and warrants for compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
703,839 |
|
|
|
|
|
|
|
|
|
|
|
703,839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
warrant term extension
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
482,964 |
|
|
|
|
|
|
|
|
|
|
|
482,964 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant
liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,284,841 |
) |
|
|
|
|
|
|
|
|
|
|
(1,284,841 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,461,904 |
) |
|
|
(4,461,904 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2006
|
|
|
- |
|
|
|
- |
|
|
|
17,460,181 |
|
|
|
17,460 |
|
|
|
14,507,939 |
|
|
|
- |
|
|
|
(13,241,135 |
) |
|
|
1,284,264 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative
effect of change in
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
accounting principle:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjust retained earnings at
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January 1, 2007 for change in
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
accounting principle
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(521,187 |
) |
|
|
(521,187 |
) |
Reclassification of warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,284,841 |
|
|
|
|
|
|
|
|
|
|
|
1,284,841 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock and warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
in
private placement for cash less issuance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
expense
of $377,169
|
|
|
|
|
|
|
|
|
|
|
7,478,462 |
|
|
|
7,479 |
|
|
|
4,476,352 |
|
|
|
|
|
|
|
|
|
|
|
4,483,831 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise
of common stock warrants
|
|
|
|
|
|
|
|
|
|
|
18,000 |
|
|
|
18 |
|
|
|
2,682 |
|
|
|
|
|
|
|
|
|
|
|
2,700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
option based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
438,263 |
|
|
|
|
|
|
|
|
|
|
|
438,263 |
|
The
accompanying notes are an integral part of these financial
statements.
ARBIOS
SYSTEMS, INC.
(A
Development Stage Company)
STATEMENT
OF STOCKHOLDERS’ EQUITY
PERIOD
FROM AUGUST 23, 2000 (INCEPTION) TO DECEMBER 31, 2008
|
|
Preferred
Stock
|
|
|
Common
Stock
|
|
|
Additional
Paid-In
|
|
|
Deferred
|
|
|
Accumulated
During the Development
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Costs
|
|
|
Stage
|
|
|
Total
|
|
Stock
warrant term extension
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
59,025 |
|
|
|
|
|
|
|
|
|
59,025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted
stock based compensation expense
|
|
|
|
|
|
|
|
|
621,818 |
|
|
|
621 |
|
|
|
315,604 |
|
|
|
|
|
|
|
|
|
316,225 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of warrants for patent acquistion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
74,570 |
|
|
|
|
|
|
|
|
|
74,570 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,552,650 |
) |
|
|
(5,552,650 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2007
|
|
|
- |
|
|
|
- |
|
|
|
25,578,461 |
|
|
|
25,578 |
|
|
|
21,159,276 |
|
|
|
- |
|
|
|
(19,314,972 |
) |
|
|
1,869,882 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
option based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114,824 |
|
|
|
|
|
|
|
|
|
|
|
114,824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
warrant term extension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
175,256 |
|
|
|
|
|
|
|
|
|
|
|
175,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted
stock based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
107,933 |
|
|
|
|
|
|
|
|
|
|
|
107,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock for compensation
|
|
|
|
|
|
|
|
|
|
|
214,286 |
|
|
|
214 |
|
|
|
59,786 |
|
|
|
|
|
|
|
|
|
|
|
60,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,273,501 |
) |
|
|
(2,273,501 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2008
|
|
|
- |
|
|
|
- |
|
|
|
25,792,747 |
|
|
$ |
25,792 |
|
|
$ |
21,617,075 |
|
|
|
- |
|
|
$ |
(21,588,473 |
) |
|
$ |
54,394 |
|
The
accompanying notes are an integral part of these financial
statements.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(1) Summary
of Significant Accounting Policies:
General:
Arbios
Systems, Inc., a Delaware corporation (the “Company”), seeks to develop,
manufacture and market liver assist devices to meet the urgent need for therapy
of liver failure.
The
Company has a lead product under development, the SEPET™ Liver Assist Device,
which is a blood purification therapy device for patients with liver
failure. The Company had a second product candidate, the HepatAssist™
Cell-Based Liver Support System, which is a bioartificial liver. The
Company entered into an Asset Purchase Agreement with HepaLife Technologies, Inc
on October 3, 2008 and subsequently sold the HepatAssist™ Cell-Based Liver
Support System.
On
October 30, 2003, Historical Autographs U.S.A., Inc. and Arbios Technologies,
Inc. (“ATI”) consummated a reverse merger, in which ATI became the wholly owned
subsidiary of Historical Autographs U.S.A., Inc. Concurrently with
the merger, Historical Autographs U.S.A., Inc. changed its name to Arbios
Systems, Inc. and is herein referred to as “Arbios Systems”. The stockholders of
ATI transferred ownership of one hundred percent of all the issued and
outstanding shares of their capital stock of ATI in exchange for 11,930,598
newly issued shares, or approximately 90%, of the common stock, $.001 par value,
of Arbios Systems. At that time, the former management of Arbios
Systems resigned and was replaced by the same persons who served as officers and
directors of ATI. Inasmuch as the former owners of ATI controlled the combined
entity after the merger, the combination was accounted for as a purchase by ATI
as acquirer, for accounting purposes in accordance with Statement of Financial
Accounting Standards, (“SFAS”) No. 141, “Business Combinations” using reverse
merger accounting, and no adjustments to the carrying values of the assets or
liabilities of the acquired entity were required. Proforma operating
results, as if the acquisition had taken place at the beginning of the period,
have not been presented as the operations of the acquiree were negligible. The
financial position and results of operations of Arbios Systems is included in
the statements of the Company from the date of acquisition.
On July
25, 2005, Arbios Systems completed its reincorporation as a Delaware corporation
by merging with and into Arbios Systems, Inc., a Delaware corporation
(“Arbios”). 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. Unless the context
indicates otherwise, references herein to the “Company” during periods prior to
July 26, 2005 include Arbios Systems, a Nevada corporation and ATI.
Development
Stage Enterprise:
The
Company is a development stage enterprise as defined in SFAS No. 7, “Accounting
and Reporting by Development Stage Enterprises.” The Company is
devoting substantially all of its present efforts to establish a new
business. Its planned principal commercial operations have not yet
commenced. Research and development, which were initiated in 2000, including
conducting of human clinical trials, has been suspended due to the financial
condition of the Company and its lack of adequate cash reserves. All
losses accumulated since inception, have been considered as part of the
Company’s development stage activities.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(1) Summary
of Significant Accounting Policies, Continued:
Liquidity
and Going Concern:
The
Company’s financial statements have been prepared in accordance with generally
accepted accounting principles in the United States of America, which
contemplate continuation of the Company on a going concern basis, and which
contemplates the realization of assets and the satisfaction of liabilities in
the normal course of business. The Company has incurred a net operating loss of
$2,273,501 for the year ended December 31, 2008 and an accumulated deficit of
$21,588,473 at December 31, 2008. This factor raises substantial
doubt about the Company’s ability to continue as a going
concern.
October
3, 2008, the Company executed an Asset Purchase Agreement with HepaLife and
concurrently therewith consummated the transactions contemplated thereby.
Pursuant to the Asset Purchase Agreement, the Company sold to HepaLife its
HepatAssist™ cell-based liver support system that the Company acquired in 2004
from Circe Biomedical, Inc. The Company had previously suspended its development
of the HepatAssist technology pending its receipt of additional funding for this
program from a corporate marketing partner or a significant capital raise. The
HepatAssist assets sold to HepaLife include 12 patents and patent licenses,
miscellaneous equipment, an FDA IND application including orphan drug and fast
track designation, Phase I and Phase II/III clinical protocols and clinical
data, as well as standard operating procedures for manufacturing and quality
control.
The
purchase price received by the Company for the HepatAssist assets that it sold
consisted of (i) $450,000, of which $250,000 was paid in cash at the closing and
$200,000 has been deferred for up to 18 months, (ii) a Series D warrant to
purchase up to 750,000 shares of HepaLife’s common stock at an exercise price of
$0.35 per share for a period of five years valued at $86,209 (the “Warrant”),
and (iii) the assumption by HepaLife of the Company’s obligations under certain
agreements related to the HepatAssist licenses and related agreements. The
deferred $200,000 payment is due and payable on the earlier of (i) the date on
which HepaLife has consummated one or more debt or equity financings in which
the gross proceeds received in the aggregate equal or exceed $4,000,000, or (ii)
the eighteen month anniversary of the closing date. HepaLife has granted the
Company piggy-back and certain other registration rights to register for public
resale the shares issuable upon the exercise of the Warrant. HepaLife is a
publicly traded company whose common stock is traded on the OTC Bulletin Board
under the symbol “HPLF.”
On April
1, 2009, HepaLife and the Company entered into an agreement to pay
the Company the $200,000 deferred payment now, in return for the
cancellation of the 750,000 warrant shares to purchase HepaLife common stock
that was part of the consideration in our sale of HepatAssistTM to
HepaLife. This proposed transaction is scheduled for a hearing on
April 20, 2009 before the Bankruptcy Court, which must approve any such
transaction.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(1) Summary
of Significant Accounting Policies, Continued:
Liquidity
and Going Concern:
On
January 9, 2009, the Company filed a voluntary petition for relief (the
“Bankruptcy Filing”) under Chapter 11 of the United States Bankruptcy Code in
the United States Bankruptcy Court for the District of Delaware (the “Bankruptcy
Court”).
The
Company’s Chapter 11 case is administered by the Bankruptcy Court as Case No.
09-10082. In the bankruptcy proceedings, the Company intends to
continue to seek bids for the sale of its technology and other assets while
working with its creditors.
On March
9, 2009, Arbios Systems, Inc. entered into a term sheet with Arbios Acquisition
Partners, LLC (“Acquisition Partners”), a privately held, limited liability
company formed for the purpose of effecting the transaction contemplated by the
Term Sheet. On March 16, 2009, the initial $100,000 deposit was
received. Pursuant to the term sheet, the Company agreed to enter into a
transaction pursuant to a plan of reorganization that is subject to the approval
of the Bankruptcy Court and all of the Company’s relevant
classes, whereby the Company will (i) cancel
all of its currently existing equity (including, but not limited to, any and all
outstanding common and preferred shares of stock, warrants, and options), and
(ii) issue new shares of its common stock to Acquisition Partners representing
90% of the newly issued shares of the Company in exchange for a $1,000,000 cash
payment. The existing shareholders of the Company would receive the
remaining 10% of the newly issued shares of the Company.
The
$1,000,000 cash purchase price to be paid by Acquisition Partners for 90% of the
Company’s shares of common stock is required to be paid as follows: 1) $100,000
was paid to the Company concurrently with the execution and delivery of the term
sheet, 2) $100,000 is due upon the later of (i) April 8, 2009 or (ii)
the filing of the Plan and the disclosure statement, and 3) $800,000 is due
within 10 days following the confirmation of the Plan.
If
Acquisition Partners has not provided the Remaining Funds by the Funding Date,
the Company will retain both the Initial Deposit and the Subsequent Deposit, and
can then either adjourn the Funding Date, withdraw the Plan, terminate the Plan,
and/or enter into an alternative transaction or proceeding. If the
Plan has not been confirmed by June 15, 2009, Acquisition Partners will be
entitled to a return of (i) the Initial Deposit, and (ii) the Subsequent Deposit
minus costs and expenses, (including, without limitation, administrative
expenses) incurred by the Company in pursuing the Plan.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(1) Summary
of Significant Accounting Policies, Continued:
Liquidity
and Going Concern:
Acquisition
Partners will be entitled to a break up fee of 3% of the funds deposited by
Acquisition Partners if the Company elects to enter into an alternative
transaction, including, but not limited to, signing a letter of intent or term
sheet with a third party, for some or all of its assets prior to confirmation of
the Plan (the “Company Withdrawal Option”), provided that the Debtor Withdrawal
Option is not caused by Acquisition Partner’s inability to provide funding by
the Funding Date. In addition, if the Company exercises the Debtor
Withdrawal Option, Acquisition Partners would also be entitled to a return of
the funded portion of the deposit. The Company is dependent upon
approval of the Plan of Reorganization in order to complete the transaction with
Acquisition Partners.
The
Company intends to continue to comply with all of its regulatory filings with
the Securities and Exchange Commission and expects that its shares of common
stock will continue to be listed on the OTC Bulletin Board. After the
completion of the transaction contemplated by the Term Sheet, the Company is
expected to emerge from bankruptcy as a publicly traded company that has no
liabilities (other than ordinary operating expenses), has a new capital
structure (Acquisition Partners will own 90% of the common stock, the public
stockholders will own a pro
rata share of the 10%, and all options and warrants will be cancelled),
and has some operating capital (the amount of the $1,000,000 purchase price that
is not used to settle existing liabilities and pay for administrative expenses).
The Term Sheet provides that the confirmation of the Plan should occur on or
before May 15, 2009.
Use
of Estimates:
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates.
Significant estimates were used in the calculation of stock option valuation,
warrant liability valuation, property and equipment, and amortization of
patents.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(1) Summary
of Significant Accounting Policies, Continued:
Comprehensive
Income:
SFAS No.
130, "Reporting Comprehensive Income", establishes standards for the reporting
and display of comprehensive income and its components in the financial
statements. As of December 31, 2008 and 2007, the Company has no items that
represent comprehensive income and therefore, the Company has not included a
schedule of comprehensive income in the financial statements.
Property
and Equipment:
Property
and equipment are stated at cost. Depreciation is provided using the
straight-line method over the estimated useful lives of the assets of five to
seven years.
Patent
Rights:
In
accordance with SFAS No. 2, “Accounting for Research and Development Costs” the
costs of intangible assets that are purchased from others for use in research
and development activities and that have alternative future uses are capitalized
and amortized. The Company capitalizes certain patent rights that are believed
to have future economic benefit. The licensed capitalized patents
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.
The
Company periodically evaluates whether events or circumstances have occurred
that may affect the estimated useful lives or the recoverability of the
remaining balance of the patents. Impairment of the assets is
triggered when the estimated future undiscounted cash flows do not exceed the
carrying amount of the intangible assets. If the events or
circumstances indicate that the remaining balance of the assets may be
permanently impaired, such potential impairment will be measured based upon the
difference between the carrying amount of the assets and the fair value of such
assets, determined using the estimated future discounted cash flows
generated.
The
patents were sold on October 3, 2008 to HepaLife in conjunction with the sale of
the HepatAssist program and related assets to HepaLife Technologies, Inc. (see
note 2).
Investments:
The
investment consists of a Series D warrant to purchase up to 750,000 shares of
HepaLife’s common stock at an exercise price of $0.35 per share for a period of
five years commencing October 3, 2008. and is classified as
available-for-sale.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(1) Summary
of Significant Accounting Policies, Continued:
Fair
Value of Financial Instruments:
The
Company’s financial instruments include cash, short-term investments,
investments, accounts payable, accrued expenses, and warrant liability, some of
which have carrying amounts which approximate fair value due to their short
maturities.
Cash
and Cash Equivalents:
The
Company considers highly liquid debt instruments with original maturities of 90
days or less to be cash equivalents.
Income
Taxes:
The
Company accounts for income taxes under SFAS No. 109, “Accounting for Income
Taxes” (“SFAS 109”). This statement requires the recognition of
deferred tax assets and liabilities for the future consequences of events that
have been recognized in the Company’s financial statements or tax returns. The
measurement of the deferred items is based on enacted tax laws. In the event the
future consequences of differences between financial reporting bases and the tax
bases of the Company’s assets and liabilities result in a deferred tax asset,
SFAS No. 109 requires an evaluation of the probability of being able to realize
the future benefits indicated by such asset. A valuation allowance related to a
deferred tax asset is recorded when some portion or the entire deferred tax
asset will not be realized on a more likely than not basis. Based on the
Company’s assessment of all available evidence, the Company has concluded that
its deferred tax assets are not more likely than not to be realized. This
conclusion is based primarily on our history of net operating losses, and the
need to generate significant amounts of taxable income in future periods on a
consistent and prolonged basis in order to utilize the deferred tax
assets.
In July
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation Number 48, “Accounting for Uncertainty in Income Taxes, an
Interpretation of FASB Statement No. 109,” (“FIN 48”). FIN 48
provides guidance on recognition, derecognition, measurement, classification,
interest and penalties, accounting in interim periods, disclosure and
transition. FIN 48 requires an entity to recognize the financial
statement impact of a tax position when it is more likely than not that the
position will be sustained upon examination. The amount recognized is
measured as the largest amount of benefit that is greater than fifty percent
likely of being realized upon ultimate settlement. In addition, FIN
48 permits an entity to recognize interest and penalties related tax
uncertainties either as income tax expenses or operating
expenses. Accordingly, the Company recognizes interest and penalties
related to tax uncertainties as income tax expense.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(1) Summary
of Significant Accounting Policies, Continued:
Income
Taxes:
The
Company has concluded that there are no significant uncertain tax positions
requiring recognition in its financial statements and did not record any
unrecognized tax benefits. As a result, the adoption of
FIN 48
did not have a material impact on the Company’s results of operation and
financial position as of December 31, 2008.
The
Company is subject to U.S. federal income tax as well as to income tax of
multiple state jurisdictions. Federal income tax returns of the
Company are subject to IRS examination for the 2005 through 2007 tax
years. State income tax returns are subject to examination for a
period of three to four years after filing.
Stock-Based
Compensation:
Commencing
January 1, 2006, the Company adopted SFAS No. 123R, “Share Based Payment,”
(“SFAS 123R”) which requires all share-based payments, including grants of stock
options, to be recognized in the income statement as an operating expense, based
on fair values.
Under
SFAS 123R, forfeitures are estimated at the time of valuation and reduce expense
ratably over the vesting period. This estimate is adjusted
periodically based on the extent to which actual forfeitures differ, or are
expected to differ, from the previous estimate. The Company utilized
a 5% forfeiture rate based upon historical forfeitures. Under SFAS
123 and APB 25, the Company elected to account for forfeitures when awards were
actually forfeited, at which time all previous pro forma expense was reversed to
a reduced pro forma expense for the period in which the forfeiture
occurred.
For
non-employee stock based compensation, the Company recognizes an expense in
accordance with SFAS 123 and values the equity securities based on the fair
value of the security on the date of grant with subsequent adjustments based on
the fair value of the equity security as it vests. The fair value of expensed
options is estimated using the Black Scholes option-pricing model.
As of
December 31, 2008, there was no unrecognized compensation cost related to
non-vested share-based compensation arrangements granted under existing stock
option plans. The total fair value of shares vested and unvested
during year ended December 31, 2008 was $137,966, of which all are attributed to
employee options.
The fair
value of options granted to employees was estimated using the Black Scholes
option-pricing model. The options granted vest based upon the vesting schedule
determined at the time of grant or the achievements of performance-based
milestones. These same assumptions are also used in applying the Black Scholes
option-pricing model for any stock based option and warrant compensation paid to
non-employees. The fair value of options and warrants at the date of grant and
the assumptions utilized are indicated in the following table:
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(1) Summary
of Significant Accounting Policies, Continued:
Stock-Based
Compensation:
|
|
For
the Year Ended December 31 ,
|
|
|
2008
|
|
2007
|
Weighted
average of fair value at date of grant for options
granted during the period
|
|
$0.39
|
|
$0.55
|
Risk-free
interest rates |
|
2.30%
- 2.98%
|
|
3.67%
- 4.88%
|
Expected
option life in years |
|
7
|
|
7
|
Expected
stock price volatility |
|
.84
– 1.00
|
|
.79
- .85
|
Expected
dividend yield |
|
0%
|
|
0%
|
Risk-Free Interest Rate. The
interest rate used in valuing awards is based on the yield at the time of grant
of the U.S. Treasury security 5 year constant maturity rate.
Expected Term. The expected
term is based on historical observations of employee exercise patterns during
the Company’s history.
Expected Volatility. The
Company calculates the expected volatility of its stock options using historical
volatility of weekly stock prices.
Dividend Yield. The Company
has never paid cash dividends, and does not currently intend to pay cash
dividends, and thus has assumed a 0% dividend yield.
Net
Loss Per Common Share:
The
Company utilizes SFAS No. 128, “Earnings per Share.” Basic loss per
share is computed by dividing loss available to common shareholders by the
weighted-average number of common shares outstanding. Diluted loss
per share is computed similar to basic loss per share except that the
denominator is increased to include the number of additional common shares that
would have been outstanding if the potential common shares had been issued and
if the additional common shares were dilutive. The computation of diluted loss
per share does not assume conversion, exercise or contingent exercise of
securities that would have an anti-dilutive effect on losses. For the
years ended December 31, 2008 and 2007, potential common shares aggregating
14,764,333 and 20,469,000, respectively, were excluded in computing the per
share amounts because they are anti-dilutive.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(1) Summary
of Significant Accounting Policies, Continued:
Recent
Accounting Pronouncements:
In
September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” or SFAS
157. SFAS 157 establishes a single authoritative definition of fair value, sets
out a framework for measuring fair value, and requires additional disclosures
about fair-value measurements. SFAS 157 applies only to fair value measurements
that are already required or permitted by other accounting standards (except for
measurements of share-based payments) and is expected to increase the
consistency of those measurements. Accordingly, SFAS 157 does not require any
new fair value measurements. However, for some entities, the application of SFAS
157 will change current practice. SFAS 157 is effective for fiscal years
beginning after November 15, 2007, and interim periods within those fiscal
years. The adoption of FAS 157 did not have a material impact on the financial
position or results of operations.
In
February 2007, the FASB issued FASB Statement No.159: “The Fair Value Option for
Financial Assets and Financial Liabilities – including an amendment of FASB
Statement No. 115” (“FAS 159”). This statement permits entities to choose to
measure many financial instruments and certain other items at fair value and is
expected to expand the use of fair value measurement. FASB 159 is effective for
fiscal years beginning after November 15, 2007. The Company has adopted FAS 159
and the adoption did not have a material impact on the financial position or
results of operations.
On June
27, 2007, the FASB reached a final consensus on EITF Issue No. 07-03:
“Accounting for Advance Payments for Goods or Services to Be Used in Future
Research and Development Activities” (“EITF 07-03”). Currently, under FASB
Statement No. 2: “Accounting for Research and Development Costs,” nonrefundable
advance payments for future research and development activities for materials,
equipment, facilities and purchased intangible assets that have no alternative
future use are expensed as incurred. EITF 07-03 addresses whether such
non-refundable advance payments for goods or services that have no alternative
future use and that will be used or rendered for research and development
activities should be expensed when the advance payments are made or when the
research and development activities have been performed. The consensus reached
by the FASB requires companies involved in research and development activities
to capitalize such non-refundable advance payments for goods and services
pursuant to an executory contractual arrangement because the right to receive
those services in the future represents a probable future economic benefit.
Those advance payments will be capitalized until the goods have been delivered
or the related services have been performed. Entities will be required to
evaluate whether they expect the goods or services to be rendered. If an entity
does not expect the goods to be delivered or services to be rendered, the
capitalized advance payment will be charged to expense. The consensus on EITF
07-03 is effective for financial statements issued for fiscal years beginning
after December 15, 2007, and interim periods within those fiscal years. Earlier
application is not permitted. Entities are required to recognize the effects of
applying the guidance in EITF 07-03 prospectively for new contracts entered into
after the effective date. In accordance with EITF 07-03, the Company does
evaluate its research and development contracts and payments within the guidance
of EITF 07-03 and either expenses or capitalizes such payments based upon the
contract terms.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(1) Summary
of Significant Accounting Policies, Continued:
Recent
Accounting Pronouncements:
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities” The new standard is intended to improve financial
reporting about derivative instruments and hedging activities by requiring
enhanced disclosures to enable users of the financial statements to better
understand the effects on an entity’s financial position, financial performance,
and cash flows. It is effective for financial statements issued for fiscal years
and interim periods beginning after November 15, 2008, with early application
encouraged. The Company is evaluating the impact of adopting SFAS 161 on our
financial statements.
(2) Sale of HepatAssist
Program:
On
October 3, 2008, the Company executed an Asset Purchase Agreement with HepaLife
and concurrently therewith consummated the transactions contemplated thereby.
Pursuant to the Asset Purchase Agreement, the Company sold to HepaLife its
HepatAssist™ cell-based liver support system that the Company acquired in 2004
from Circe Biomedical, Inc. The Company had previously suspended its development
of the HepatAssist technology pending its receipt of additional funding for this
program from a corporate marketing partner or a significant capital raise. The
HepatAssist assets sold to HepaLife included 12 patents and patent licenses,
miscellaneous equipment, an FDA IND application including orphan drug and fast
track designation, Phase I and Phase II/III clinical protocols and clinical
data, as well as standard operating procedures for manufacturing and quality
control.
The
purchase price received by the Company for the HepatAssist assets that it sold
consisted of (i) $450,000, of which $250,000 was paid in cash at the closing and
$200,000 has been deferred for up to 18 months, (ii) a Series D warrant to
purchase up to 750,000 shares of HepaLife’s common stock at an exercise price of
$0.35 per share for a period of five years valued at $86,209 (the “Warrant”),
and (iii) the assumption by HepaLife of the Company’s obligations, if any, under
certain agreements related to the HepatAssist licenses and related agreements.
The deferred $200,000 payment is due and payable on the earlier of (i) the date
on which HepaLife has consummated one or more debt or equity financings in which
the gross proceeds received in the aggregate equal or exceed $4,000,000, or (ii)
the eighteen month anniversary of the closing date. HepaLife has granted the
Company piggy-back and certain other registration rights to register for public
resale the shares issuable upon the exercise of the Warrant. HepaLife is a
publicly traded company whose common stock is traded on the OTC Bulletin Board
under the symbol “HPLF.”
Capitalized
patents with an amortized value of $116,933 and equipment with a depreciated
book value of $14,413 were transferred on October 3, 2008 to HepaLife
Technologies, Inc. in conjunction with the sale of the HepatAssist program and
its related assets.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(2) Sale of HepatAssist Program
(continued):
The
Series D warrant to purchase up to 750,000 shares of HepaLife’s common stock was
initially valued utilizing the Black Scholes model with the following
assumptions: 5 year expected life, 2.73% risk free rate, .96
volatility and 0.0% dividend rate.
(3) Cumulative Effect of a Change in
Accounting Principle:
In
accordance with SFAS No. 154: “Accounting Changes and Error Corrections,” (“FASB
154”) the Company recorded a change in accounting principal related to FASB’s
Emerging Issues Task Force Issue No. 00-19-2, “Accounting for Registration
Payment Arrangements,” (“EITF 00-19-2”). EITF 00-19-2 was issued December 21,
2006 and is effective for fiscal periods beginning after December 15, 2006, and
requires the registration rights agreement and any registration rights payments
to be considered separately from the financial instruments. In accordance with
EITF 00-19-2, the Company reversed the classification of the warrant liability
associated with the warrants issued in the 2005 and 2006 financings from debt to
equity during the period ended March 31, 2007. The warrants and registration
rights agreement were previously accounted for as a single instrument, and
without the consideration of the registration rights payments the warrants are
properly classified as equity in accordance with EITF 00-19. The Company
reviewed the instruments entered into in connection with the April 2007
financing discussed in Note 8 below and determined that the financing did not
have any embedded derivatives requiring derivative accounting
treatment.
(4) Property
and Equipment:
Property
and equipment consisted of the following:
|
|
2008
|
|
|
2007
|
|
Office
equipment
|
|
$ |
6,435 |
|
|
$ |
8,589 |
|
Office
furniture
|
|
|
3,174 |
|
|
|
7,297 |
|
Computer
equipment
|
|
|
10,376 |
|
|
|
38,546 |
|
Medical
equipment
|
|
|
37,971 |
|
|
|
107,993 |
|
|
|
|
57,956 |
|
|
|
162,425 |
|
Less:
accumulated depreciation
|
|
|
(51,779 |
) |
|
|
(116,975 |
) |
|
|
$ |
6,177 |
|
|
$ |
45,450 |
|
Depreciation
expense was $18,413, $29,565 and $51,779 for the years ended December 31, 2008
and 2007, and the period from August 23, 2000 (inception) to December 31, 2008,
respectively.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(5) Patent
Rights:
In June
2001, the Company acquired, in exchange for junior preferred stock, exclusive
rights to five existing patents, at which time the aggregate value of these
rights was $400,000. The patents were sold on October 3, 2008 to
HepaLife Technologies, Inc. in conjunction with the sale of the HepatAssist
program and related assets. At December 31, 2008 and 2007, the
accumulated amortization of these rights was $0 and $134,374,
respectively. Amortization expense was $15,360 for the year ended
December 31, 2008 and $20,480 for the year ended December 31, 2007 and $191,373
for the period from August 23, 2000 (inception) to December 31,
2008.
In March,
2007, the Company in-licensed a family of U.S. patents plus foreign counterparts
and pending patent applications, and certain related trade
secrets. The issued patents include broad claims for methods of
treating liver failure, multi-organ failure, multi-organ dysfunction syndrome,
sepsis, septic shock, systemic inflammatory response syndrome, and related
inflammatory disorders by selective blood filtration. The
patents and applications relate to the use of blood filtration devices which
remove, from the blood of patients with the above disease conditions, a broad
spectrum of inflammatory and other disease mediators ranging from small
molecules through intermediate size blood proteins with molecular weights up to
the size of beneficial immunoglobulins. The patents and/or
applications also relate to the combined use of replacement fluids including
human serum albumin or combined uses of secondary selective plasma adsorption
devices and/or certain classes of anti-inflammatory therapeutic drugs, and to
apparatus suitable for the above uses.
Included
in this in-licensed family are five issued U.S. patents, four pending U.S.
patents, and two pending European patents. The Company will owe
royalties on net sales of products which are covered by the license, including
potentially the SEPET™ Liver Assist Device, ranging from low- to mid-single
digit percentages of net sales. The Company will also owe maintenance
fees and certain other minimum spending obligations under the license and may
owe contingent milestone fees. The Company’s fixed obligations under
the license will total less than $500,000 over the next 4 years, a portion of
which includes spending on future product development possibly leading to future
sales revenues for the Company. The Company’s contingent obligations
under the license will total less than $500,000 over approximately the same
period: however, payments will be dependent on the pace of potential future
patent issuances. The Company is also obligated to raise an
aggregate of $5.2M by December 31, 2008 in order to maintain the exclusivity of
the patent portfolio per the terms of the licensing agreement. On
January 2, 2009, Immunocept, LLC declared a default in its License Agreement,
dated March 29, 2007, with the Company.
In
connection with the license, the Company has also issued a warrant to the
licensor for 225,000 common shares with an exercise price of $1.50 per share and
a 6-year term expiring in March, 2013.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(6) Investments:
Available-for-Sale
Investments
The
following table summarizes our long-term investments classified as
available-for-sale at December 31, 2008:
|
|
Cost
|
|
|
Gross
unrealized
gains
|
|
|
Unrealized
losses
|
|
|
Fair
value
|
|
Investment-
HepaLife Warrants
|
|
$ |
86,209 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
86,209 |
|
(7) Commitments
and Contingencies:
Description of
Property
The
Company previously maintained its research offices and laboratories in Medford,
Massachusetts where it leased 1,783 square feet at $5,044 per month with a term
of one year that was entered into on September 15, 2007. The Medford laboratory
lease expired on September 15, 2008 and was not renewed. The Company also
previously maintained its corporate headquarters in Waltham, Massachusetts where
it leased 600 square feet for approximately $3,900 per month. The
Waltham office lease expired on October 31, 2008 and was not
renewed. In order to conserve its cash reserves, the Company
transferred its corporate office from Waltham, Massachusetts to Pasadena,
California and currently maintains approximately 300 square feet of
administrative office which is leased on a month-to-month basis for $750 per
month.
Rent expense was $112,555, $186,236, and $991,285 for the years ended
December 31, 2008 and 2007, and the period from August 23, 2000 (inception) to
December 31, 2008, respectively.
Agreements
On
September 14, 2007, the Company entered into a Supply Agreement (the “Supply
Agreement”) with Membrana GmbH, a company organized under the laws of Germany
(“Membrana”), for the provision of membranes for use in the Company’s SEPET™
therapeutic blood filtration products for the treatment of liver failure and
sepsis. The Supply Agreement provides that following the first commercial sale
of the Company’s product that contains Membrana membranes, Membrana will be the
Company’s exclusive supplier of certain identified membranes for use in certain
of the Company’s products. In addition, the agreement provides that following
the first commercial sale of the Company’s product
that contains Membrana membranes, Membrana shall not supply certain identified
membranes for use
in one of the Company’s products to any third party that will incorporate such
membranes into a product whose composition, method of manufacture or method of
use falls within a claim of one of the Company’s issued U.S. Such exclusivity
may last for up to five years based upon the fulfillment of certain minimum
purchase thresholds by the Company. The agreement also provides for
pre-established per-unit pricing of Membrana membranes, including progressive
quantity discounts.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(7) Commitments
and Contingencies - continued:
The
Supply Agreement will terminate following the six-year anniversary of the date
of the first commercial sale of the Company’s product that contains Membrana
membranes. The Supply Agreement may be terminated by either party upon ninety
days notice in the event of a material breach by the other party that remains
uncured for ninety days, or upon sixty days notice if the other party becomes
insolvent or becomes the subject of any voluntary or involuntary proceeding in
bankruptcy, liquidation, dissolution, receivership, or general assignment for
the benefit of creditors that is not dismissed within sixty days. In addition,
upon sixty days notice, the Company may terminate the Supply Agreement or
terminate the exclusivity of the Supply Agreement, upon Membrana’s failure to
meet certain delivery requirements. As of the date of the filing of
this report, the Company has not received notice from Membrana of its intention
to terminate the agreement.
On
October 19, 2007, the Company entered into a Manufacturing & Supply
Agreement (the “Supply Agreement”) with NxStage Medical, Inc. (“NxStage”) for
the manufacture and supply of the Company’s SEPET™ Liver Assist Device for use
in clinical trials and for commercial sale. The Supply Agreement provides that
NxStage will be the Company’s exclusive manufacturer and supplier of the SEPET™
Liver Assist Device for commercial sale until the fifth anniversary of
regulatory approval of the device. Under the Supply Agreement, NxStage will not
manufacture, supply or sell the Company’s device to other parties and if NxStage
manufactures, supplies or sells a competing product, as defined in the Supply
Agreement, subject to certain exceptions, the Company may terminate the
arrangement or convert it into a non-exclusive arrangement. In addition, if the
Company purchases more than a certain number of devices in one calendar year,
the Company will be subject to an annual minimum purchase requirement for the
remainder of the agreement, which minimum will be subject to adjustment each
year. The Supply Agreement provides for pre-established per-unit pricing,
including quantity discounts and yearly adjustments.
The
Supply Agreement will terminate upon the earlier of (i) the seventh anniversary
of regulatory approval of the device or (ii) the seventh anniversary of the date
of the Supply Agreement if regulatory approval of the device is not obtained by
such date. The Supply Agreement may be terminated by either party (i) upon an
extended prior notice period, (ii) upon a material breach by the other party
that remains uncured, or (iii) upon notice if the other party becomes insolvent,
files for bankruptcy, goes into liquidation or a receiver is appointed over all
or a major part of the other parties’ assets. In addition, the Company may
terminate the Supply Agreement or terminate the exclusivity of the Supply
Agreement, upon the occurrence of certain events. As of the date of
the filing of this report, the Company has not received notice from NxStage of
its intention to terminate the agreement.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity:
Preferred
Stock
The
Company has 5,000,000 shares of preferred stock authorized. There are no shares
of preferred stock issued or outstanding. The Board of Directors has
the authority to set by resolution the particular designation, preferences and
other special rights and qualification of preferred stock.
Junior Preferred
Stock
In June
2001, ATI issued 681,818 shares of junior preferred stock in exchange for
$250,000 in cash, exclusive rights to certain patents and one pending patent
valued at $400,000 (see Note 4), and future services of certain employees valued
at $319,553 (see Note 5). In October 2003, all issued and outstanding
shares of the junior preferred stock were converted into 681,818 shares of
common stock.
Common Stock
In August
2000, ATI issued 5,000,000 shares of common stock, $0.001 par value, to the
Company’s two founders in exchange for $5,000 in cash.
In
December 2001, ATI issued 362,669 shares of common stock in exchange for future
research costs valued at $550,000, an exclusive license, a manufacturing and
supply agreement, and exclusive rights to two patents. The
manufacturing and supply agreement has ended and one of the patents has
expired.
In June
2002, ATI issued 70,000 shares of common stock to a Board member as compensation
for services rendered valued at $10,500.
In July
2002, ATI issued 999,111 shares of common stock to investors in exchange for
$149,866 in cash, or $0.15 per share.
In July
2002, ATI issued options to purchase 18,000 shares of common stock to each of
its five Board members for services rendered. The options are
exercisable at $0.15 per share. The options vested 50% in six months
and 50% in 12 months from the beginning date of service provided by the
respective Board members. Three Board members have resigned and
had their options expire as of December 31, 2007.
In July
2002, ATI issued a warrant to purchase 100,000 shares of common stock to a Board
member for services rendered to the Company. The warrant is
exercisable at $0.15 per share and has a 7-year life. The warrant
also has conversion rights in lieu of payment of the exercise price and is not
transferable.
In
January 2003, ATI issued 417,000 shares of common stock and a three year warrant
to purchase 600,000 shares of common stock at an exercise price of $1.00 per
share to an investor in exchange for $250,200 in cash. The Company recognized
$2,956 in stock issuance costs. The warrant expiration date of
January 23, 2006 was extended to February 15, 2010 in exchange for the
investor’s agreement to not sell his Company stock holdings until February 15,
2009.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
Common
Stock
In July
2003, ATI issued a warrant to purchase 50,000 shares of common stock to a Board
member for services rendered to the Company. The warrant is
exercisable at $1.00 per share and has a five-year life. The warrant grant
resulted in a non-cash charge of $7,180 determined utilizing the Black Scholes
pricing model and the following economic assumptions: dividend yield 0%,
volatility .05, risk free interest rate 3% and an expected life of 5
years.
In
September 2003, convertible promissory notes totaling $400,000 were converted
into 400,000 shares of the Company’s common stock. The Company also issued
warrants to purchase 300,000 shares of common stock. The warrants are
exercisable at $1.00 per share and have a three-year life. The
warrant expiration date of September 29, 2006 was extended until February 15,
2010 in exchange for the investors’ agreements to not sell their stock until
February 15, 2009
In
September and October 2003, ATI issued 4,000,000 shares of common stock and
warrants to purchase 4,000,000 shares of common stock at an exercise price of
$2.50 in exchange for $4,000,000 in cash. The warrant expiration date of October
29, 2006 was extended until October 29, 2008 in exchange for lowering the call
provision of the warrant. The Company recognized $519,230 in stock
issuance costs, which was comprised of $505,500 in third party fees and $13,730
in related legal fees. These costs were charged against additional
paid in capital.
In
October 2003, ATI entered into a reorganization transaction wherein the
stockholders of Arbios Systems retained 1,220,000 shares of the reorganized
entity after the transaction. Since Arbios Systems was treated as the acquired
company for accounting purposes, those shares were accounted for as being issued
as of that date.
In
January 2004, Arbios Systems issued 40,000 shares of common stock and warrants
to purchase 40,000 shares of common stock to a director as compensation for
finder’s fees. The warrant has a three-year life and is exercisable
at $2.50 per share. The warrant grant resulted in a non-cash charge
of $16,000 determined utilizing the Black Scholes pricing model and the economic
assumptions listed in Note 1, Stock Based Compensation.
In
February 2004, Arbios Systems issued 7,500 shares of common stock and a warrant
to purchase 7,500 shares of common stock to a son of a director as compensation
for finder’s fees. The warrant has a three-year life and is
exercisable at $2.50 per share. The warrant grant resulted in a
non-cash charge of $11,000 determined utilizing the Black Scholes pricing model
and the following economic assumptions: dividend yield 0%, volatility .86-.96,
risk free interest rate 3.53%-3.0% and an expected life of 3-7
years.
In March
2004, Arbios Systems entered into a retainer agreement with an investor
relations firm and issued a warrant to purchase 150,000 shares of common stock
as compensation. The warrant has a five year life and is exercisable
at $3.40 per share. Pursuant to the terms of the warrant, the number
of shares that can be purchased under the warrant was reduced in December 2004
to 75,000 shares. The warrant grant resulted in a non-cash charge of
$203,000 determined utilizing the Black Scholes pricing model and the following
economic assumptions: dividend yield 0%, volatility .86-.96, risk free interest
rate 3.53%-3.0% and an expected life of 3-7 years.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
Common
Stock
In July
2004, Arbios Systems entered into an agreement with an investor relations firm
based in Switzerland to perform investor relation services for the Company in
Europe. The Company issued two warrants to purchase an aggregate of 100,000
shares of common stock. The first warrant for 50,000 shares vested
immediately with an exercise price of $1.50 per share and has a five-year
expiration term. The second warrant for 50,000 shares vested ratably each month
over one year with an exercise price of $3.50 per share and has a five-year
expiration term. The warrant grants resulted in a non-cash charge of
$298,000 determined utilizing the Black Scholes pricing model and the following
economic assumptions: dividend yield 0%, volatility .86-.96, risk free interest
rate 3.53%-3.0% and an expected life of 3-7 years.
In
October 2004, an option holder exercised his option to purchase 18,000 shares of
common stock at an exercise price of $0.15 per share.
In
January 2005, the Company completed a $6,611,905 private equity financing to a
group of institutional investors and accredited investors. In the
offering, 2,991,812 shares of the Company’s common stock were sold, at a price
of $2.21 per share and the investors also received 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 the Company 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. The placement agent in the offering was
issued warrants to purchase 114,404 shares of common stock.
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.
The
Company also entered into a Registration Rights Agreement with the investors in
the January 2005 and March 2006 private placements pursuant to which the Company
agreed to register and to maintain an effective registration statement for the
shares of common stock issued in the private placement and for the common stock
to be issued upon the exercise of warrants issued in the
transaction. The Registration Rights Agreement provides for
liquidated damages of 1.5% of the aggregate purchase price for each 30 day
period, with a maximum of eight 30-day periods (12% maximum liquidating
damages), if the Company fails to maintain the effectiveness of such
registration statement. In accordance with “Emerging Issues Task
Force Issue 00-19,”Accounting for Derivative Financial Instruments Indexed to,
and Potentially Settled in, a Company’s Own Stock”(“EITF 00-19”) and other
authoritative literature, it was determined that the warrants issued in the
January 2005 private placement and the Registration Rights Agreement are free
standing derivative financial instruments as defined in EITF
00-19. As of the
closing date of the private placement, and as of March 31, 2005, June 30, 2005,
September 30, 2005, and December 31, 2005, the warrants meet the requirements of
equity classification as specified in EITF 00-19 since the maximum amount of
liquidating damages was less than the value ascribed to the difference between
the fair value of registered versus unregistered common stock.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
Common
Stock
On April
23, 2007, the Company completed a private equity financing of $4,861,000 to a
group of current and new accredited investors which was reduced by $377,000 in
fund raising costs resulting in net proceeds of $4,484,000 to the Company. In
the offering, the Company sold 3,739,231 Units. Each Unit was sold at a price of
$1.30 per Unit. Each Unit consists of: i) two shares of common stock, ii) one
warrant to purchase one share of common stock exercisable for a period of 2.5
years at an exercise price of $1.00 (“A Warrants”) and iii) one warrant to
purchase one share of the Company’s common stock exercisable for a period of 5
years at an exercise price of $1.40 (“B Warrants”), comprising a total of
7,478,462 shares of common stock and warrants to purchase 7,478,462 shares of
common stock. The warrants have no provision for cashless exercise and, subject
to certain requirements, may be called by the Company provided that the
Company’s common stock trades above $1.50 for the A Warrants and above $2.80 for
the B Warrants for a specified time period. The placement agent received: 1) a
cash fee of $252,000, 2) a warrant to purchase 576,615 shares of common stock
with an exercise price of $0.65 and a term of five years with a Black Scholes
valuation of $275,845 utilizing the following assumptions: risk free interest
rate 4.59%, stock price volatility 0.80, expected life 5 years, dividend yield
0%, and 3) a contingent cash fee of 7% of cash proceeds generated in connection
with any additional payments, equity purchases or warrant exercises originating
from investors from the April 2007 financing within 12 months of the closing of
the financing. As a result of the April 2007 financing and pursuant to certain
anti-dilution terms of the Company’s prior equity financings, the Company
increased the number of shares issuable under the warrants issued in the 2005
and 2006 financing by approximately 702,000 shares.
In April
2007, an option holder exercised his option to purchase 18,000 shares of common
stock at an exercise price of $0.15 per share.
In April
2008, the Company issued 214,286 shares of common stock to a consultant in
exchange for services. The value of these common shares issued, based on the
closing price of the Company’s common stock on the date of issuance, was
expensed for $60,000 with a corresponding increase in additional paid in
capital.
Restricted Common
Stock
In
November 2006, the Company issued an aggregate of 89,845 shares of restricted
stock to members of the Company’s Board of Directors in lieu of cash
compensation for services rendered during the second half of
2006. The restricted stock vested 100% on June 30, 2007 and had a
market price of $0.64 per share on the date of grant.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
Restricted Common
Stock
In the
quarter ended March 31, 2007, the Company issued 82,354 shares of restricted
stock to consultants at a price of $0.01 per share. The value of restricted
shares issued, based on the closing price of the Company’s common stock on the
date of issuance, was recorded as a consulting expense of approximately $42,000
during the period the services were provided with a corresponding increase in
additional paid in capital.
In May
2007, the Company issued 15,244 shares of restricted stock to a director at a
price of $0.01 per share valued at approximately $12,000 which fully vest six
months after issuance.
In July
2007, the Company issued 134,375 shares of restricted stock to Board members as
compensation for services at a price of $0.01 per share. The value of restricted
shares issued, based on the closing price of the Company’s common stock on the
date of issuance, was expensed for approximately $112,000 with a corresponding
increase in additional paid in capital. The Company also issued 200,000 shares
of restricted stock to an investor relations consultant at a price of $0.01 per
share. The value of such restricted shares issued was approximately
$166,000.
In
September 2007, the Company issued 100,000 shares of restricted stock to an
advisor and current member of the Board of Directors as compensation for
services at a price of $0.01 per share. The value of these restricted shares
issued, based on the closing price of the Company’s common stock on the date of
issuance, was expensed for approximately $48,000 with a corresponding increase
in additional paid in capital.
In
February 2008, the Company issued 25,000 shares of restricted stock to an
advisor and current member of the Board of Directors with a milestone
contingency at a price of $0.01 per share. The value of these restricted shares
issued, based on the closing price of the Company’s common stock on the date of
issuance, was expensed for $16,000 with a corresponding increase in additional
paid in capital. The milestone was not achieved, the transaction
charges were reversed and the shares were returned to treasury.
Warrants
In
February 2005, the Company issued a warrant to purchase 200,000 shares of our
common stock to an advisor as additional compensation for services rendered to
us during the past 15 months. The warrant has a term of five years and an
exercise price of $2.90 per share (the closing trading price of our common stock
on the OTC Bulletin Board on the date of grant).
In March
2005, a warrant holder exercised his option to purchase 25,000 shares of common
stock at an exercise price of $2.50 per share.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
Warrants
On
September 28, 2006, the Company amended outstanding warrants to purchase an
aggregate of 1,300,000 shares of common stock of the Company at exercise prices
ranging from $1.00 to $2.50 (the “Warrants”). The Warrants were originally
issued to investors in 2003 in connection with certain financing transactions
and were scheduled to expire on either September 30, 2006 or October 23,
2006. The amendment extends the expiration date of the Warrants until
February 15, 2007. The value of the extension of the warrants was
calculated using a Black Scholes valuation utilizing the following
assumptions: 7 year expected life, 4.35% - 5.04% risk free rate, .72
- .77 volatility and 0.0% dividend rate and resulted in a charge of $103,000
which was booked to our income statement during the third quarter of
2006.
On
October 29, 2006, the Company amended outstanding warrants to purchase an
aggregate of 4,375,000 shares of common stock of the Company, each of which has
an exercise price of $2.50 (the “Warrants”). The Warrants were originally
issued to investors in 2003 in connection with certain financing
transactions. Warrants to purchase 3,975,000 shares of common stock were
scheduled to expire on October 29, 2006 and 400,000 of the Warrants were
scheduled to expire on February 15, 2007. The amendment extended the
expiration date of the Warrants until October 29, 2008 at which time the
warrants did expire. The value of the extension of the warrants was
calculated using a Black Scholes valuation utilizing the following
assumptions: 7 year expected life, 4.35% - 5.04% risk free rate, .72
- .77 volatility and 0.0% dividend rate and resulted in a charge of $380,000
which was booked to our income statement during the fourth quarter of
2006.
In
addition, the Warrants contain a call provision whereby the Company can require
the holders of the Warrants to exercise them if the market trading price of the
Company’s common stock trades at a level of at least $4.00 per share for 20
consecutive trading days (the “Call Provision”). In addition to
amending the expiration date of the Warrants as described in the preceding
paragraphs, the Company amended the Call Provision by lowering the trading price
at which the Call Provision may be triggered from $4.00 per share to $3.25 per
share.
In
accordance with EITF 00-19 and other authoritative literature, it was determined
that the warrants issued in the January 2005 and March 2006 private placements
and the related registration rights agreements, discussed below, were free
standing derivative financial instruments as defined in EITF
00-19. In accordance with EITF 00-19, the value and balance sheet
classification of the warrants were reviewed each reporting period and, while
the warrants were classified as a liability, any changes in the value of the
warrants on a re-measurement date were recorded in the statement of
operations.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
Warrants
On March
6, 2006, the Company completed a $1,350,000 private equity financing to a group
of institutional investors and an accredited investor. In the offering, the
Company sold 1,227,272 shares of its 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 its common stock at an exercise price of $1.50 per share. The Company
also entered into a Registration Rights Agreement with the investors in the
March 2006 private placement pursuant to which the Company agreed to register
and to maintain an effective registration statement for the shares of common
stock issued in the private placement and for the common stock to be issued upon
the exercise of warrants issued in the transaction.
In
January 2005, the Company completed a $6,611,905 private equity financing to a
group of institutional investors and accredited investors. In the
offering, 2,991,812 shares of the Company’s common stock were sold, at a price
of $2.21 per share and the investors also received 5-year warrants to purchase
an additional 1,495,906 shares of our common stock at an exercise price of $2.90
per share. The placement agent received 5-year warrants to purchase
114,404 shares of the Company’s common stock in addition to cash compensation of
$253,000 plus expenses. The Company also entered into a Registration
Rights Agreement with the investors in the January 2005 private placement
pursuant to which the Company agreed to register and to maintain an effective
registration statement for the shares of common stock issued in the private
placement and for the common stock to be issued upon exercise of warrants issued
in the transaction. As a result of the Company’s March 6, 2006 private equity
financing discussed above, an anti-dilution provision from the January 2005
private equity financing was triggered which resulted in an additional 94,033
warrant shares being issuable to warrant holders from the January 2005 private
equity financing. Additionally, the exercise price was adjusted from
$2.90 to $2.74 per share. The warrants are exercisable for five years from the
date of issuance and can be redeemed by the Company after January 11, 2007 if
the average trading price of the Company’s 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.
The
registration rights agreement associated with the January 2005 and March 2006
private placements provides for liquidated damages of 1.5% of the aggregate
purchase price for each 30 day period for a maximum of eight 30 day periods,
capped at 12%, if the Company failed to register such shares, or fails to
warrant shares or maintain the effectiveness of such registration. As
of the date the warrants were issued and for each subsequent reporting period
through December 31, 2005, the Company determined that settlement in
unregistered shares was an economic settlement alternative to delivering
unregistered shares and consequently recorded the fair value of the warrants as
equity. However, as of March 31, 2006 for the January 2005 private
placement financing and as of September
30, 2006 for the March 2006 private placement, due primarily to a reduction in
the fair market value of the Company’s common stock share price, the potential
liquidated damages exceeded the reasonable discount between registered and
unregistered shares thereby making the settlement alternative uneconomic, and
the warrants, valued at $1,285,000 were reclassified from equity to accrued
warrant liability, based on the fair value of the warrants. For the
quarters ended June 30, September 30 and December 31, 2006, the potential
liquidated damages continued to exceed a reasonable discount between the fair
value of the registered and unregistered shares, thereby making net share
settlement an uneconomic alternative. The accrued warrant liability has been
reduced by $521,000 based on the change in the fair value of the warrant
liability. The fair value of the warrant liability at December 31,
2006 was $764,000.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
The
warrants were valued using a Black Scholes option pricing
model. Further the warrant agreements from the January 2005 and March
2006 financings contain anti-dilution provisions whereby in the event that,
during the five year life of the warrants, the Company completes one or more
rounds of financing at a lower common stock offering price than the then
effective price of the warrants, 1) the exercise price of the warrants would be
adjusted downward based on a weighted average formula described in the agreement
and 2) additional warrant shares would be allocated to the warrant holder based
on the described formula. Such potential changes in exercise price
and additional warrant shares were taken into account in the valuation of the
anti-dilution provision based on the estimated potential dilutive effects of
future successive equity financings including consideration of potential cash
requirements, potential size, timing and terms of such financings, projected
future prices and volatility of the Company’s stock, and other
factors. The value of those estimated warrant shares issuable,
together with the adjusted value of the estimated warrant shares with reduced
exercise price, were determined using the Black Scholes option pricing
model.
For the
valuation of all warrants including their anti-dilution provisions, the
assumptions used in the application of the Black Scholes option pricing model
are as follows: risk free interest rate 3.71%-5.07%, stock price
volatility 0.71-0.83, expected life 1-5 years, dividend yield 0%.
On
February 2, 2007, the Company amended certain terms of outstanding warrants to
purchase an aggregate of 907,500 shares of common stock of the Company; 900,000
shares have an exercise price of $1.00 and 7,500 shares have an exercise price
of $2.50. The warrants were originally issued in 2003 and 2004 in connection
with certain financing transactions and were scheduled to expire in February
2007. The amendments extend the expiration date for warrants to purchase 900,000
shares of common stock with an exercise price of $1.00 until February 15, 2008
and extend the expiration date for the warrants to purchase 7,500 shares of
common stock with an exercise price of $2.50 until October 29, 2008 at which
time the warrants expired. The value of the extension of the warrants was
calculated using the Black Scholes pricing model and resulted in a charge of
approximately $59,000, which was recorded in the statement of operations during
the first quarter of 2007.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
In
addition, all of the extended warrants contain a call provision whereby the
Company can require the holders of the warrants to exercise the warrants if the
market trading price of the Company’s common stock trades at a level of at least
$4.00 per share for 20 consecutive trading days (the “Call Provision”). In
addition to amending the expiration date of the warrants as described in the
preceding paragraph, the Company amended the Call Provision by lowering the
trading price at which the Call Provision may be triggered from $4.00 per share
to $3.25 per share.
In March
2007, warrants to purchase 225,000 shares of common stock exercisable at $1.50
per share were issued in conjunction with the acquisition of certain patents.
The fair value of the warrants, which were expensed in March 2007, was
determined to be approximately $75,000 using the Black Scholes pricing model
utilizing the following assumptions: risk free interest rate 4.48%, stock price
volatility 0.79, expected life 6 years, dividend yield 0%.
On April
23, 2007, the Company completed a private equity financing of $4,861,000 to a
group of current and new accredited investors which was reduced by $377,000 in
fund raising costs resulting in net proceeds of $4,484,000 to the Company. In
the offering, the Company sold 3,739,231 units. Each unit was sold at a price of
$1.30 per unit. Each unit consists of: i) two shares of common stock, ii) one
warrant to purchase one share of common stock exercisable for a period of 2.5
years at an exercise price of $1.00 (“A Warrants”) and iii) one warrant to
purchase one share of the Company’s common stock exercisable for a period of 5
years at an exercise price of $1.40 (“B Warrants”), comprising a total of
7,478,462 shares of common stock and warrants to purchase 7,478,462 shares of
common stock. The warrants have no provision for cashless exercise and, subject
to certain requirements, may be called by the Company provided that the
Company’s common stock trades above $1.50 for the A Warrants and above $2.80 for
the B Warrants for a specified time period. The placement agent received: 1) a
cash fee of $252,000, 2) a warrant to purchase 576,615 shares of common stock
with an exercise price of $0.65 and a term of five years with a Black Scholes
valuation of $275,845 utilizing the following assumptions: risk free interest
rate 4.59%, stock price volatility 0.80, expected life 5 years, dividend yield
0%, and 3) a contingent cash fee of 7% of cash proceeds generated in connection
with any additional payments, equity purchases or warrant exercises originating
from investors from the April 2007 financing within 12 months of the closing of
the financing. As a result of the April 2007 financing and pursuant to certain
anti-dilution terms of the Company’s prior equity financings, the Company
increased the number of shares issuable under the warrants issued in the 2005
and 2006 financing by approximately 702,000 shares.
On
February 15, 2008, the Company amended outstanding warrants to purchase an
aggregate of 900,000 shares of common stock of the Company, which have an
exercise price of $1.00 per share (the “Warrants”). The Warrants were
originally issued in 2003 in connection with certain financing transactions and
were scheduled to expire on February 15, 2008.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
The
amendment extends the expiration date of the Warrants until February 15,
2010. The value of the extension of the warrants was calculated using
the Black Scholes pricing model and resulted in a charge of approximately
$176,000, which was recorded in the statement of operations during the first
quarter of 2008.
In
addition, the Warrants contain a call provision whereby the Company can require
the holders of the Warrants to exercise them if the Company’s common stock
trades at a level of at least $3.25 per share for 20 consecutive trading days
(the “Call Provision”). In addition to amending the expiration date
of the Warrants as described in the preceding paragraph, the Company amended the
Call Provision by lowering the trading price at which the Call Provision may be
triggered from $3.25 per share to $2.25 per share.
At
December 31, 2008, outstanding warrants to acquire shares of the Company's
common stock are as follows:
Number
of
|
|
|
Exercise
|
|
|
Shares
|
|
|
Price
|
|
Expiration date
|
|
100,000 |
|
|
$ |
0.15 |
|
August
18, 2009
|
|
900,000 |
|
|
|
1.00 |
|
February
15, 2010
|
|
75,000 |
|
|
|
3.40 |
|
April
1, 2009
|
|
50,000 |
|
|
|
1.50 |
|
August
4, 2009
|
|
50,000 |
|
|
|
3.50 |
|
August
4, 2009
|
|
200,000 |
|
|
|
1.91 |
|
February
1, 2010
|
|
2,312,702 |
|
|
|
1.91 |
|
January
11, 2010
|
|
751,877 |
|
|
|
1.22 |
|
March
6, 2011
|
|
225,000 |
|
|
|
1.50 |
|
March
29, 2013
|
|
3,739,231 |
|
|
|
1.00 |
|
October
23, 2009
|
|
3,739,231 |
|
|
|
1.40 |
|
April
23, 2012
|
|
576,615 |
|
|
|
.65 |
|
April
23, 2012
|
|
12,719,656 |
|
|
|
|
|
|
The
weighted average exercise price of warrants outstanding at December 31,
2008 was $1.32 and the weighted average remaining contractual life of the
warrants was 1.86 years.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
Warrant
transactions are summarized as follows:
|
|
For
the year ended December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
at beginning of year
|
|
|
17,152,156 |
|
|
$ |
2.29 |
|
|
|
8,165,477 |
|
|
$ |
2.29 |
|
Warrants
issued
|
|
|
- |
|
|
$ |
1.22 |
|
|
|
9,026,679 |
|
|
$ |
1.22 |
|
Warrants
forfeited
|
|
|
(4,432,500 |
) |
|
$ |
2.50 |
|
|
|
(40,000 |
) |
|
$ |
2.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
at end of year (1)
|
|
|
12,719,656 |
|
|
$ |
1.62 |
(2) |
|
|
17,152,156 |
|
|
$ |
1.62 |
(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) All
warrants are exercisable at 12/31/08
|
|
(2) Amount reflects adjusted
exercise price for certain warrants due to anti-dilution provision discussed
above.
2001 Stock Option
Plan
In 2001,
Arbios Systems adopted the 2001 Stock Option Plan (the “2001 Plan”) for the
purpose of granting incentive stock options and/or non-statutory stock options
to employees, consultants, directors and others. Under the 2001 Plan,
the Company is authorized to grant options to purchase up to 1,000,000
shares. The 2001 Plan is administered by the Board of Directors of
the Company or by a committee of the Board. However, in connection
with the reorganization transaction between Arbios Systems and ATI in October
2003, Arbios Systems assumed all of the 314,000 outstanding options granted by
ATI under its existing stock option plan and the options previously issued under
that plan were cancelled. None of the terms of the assumed options were changed.
The options assumed under the Arbios Systems Plan are identical to the options
that were previously granted under the ATI Plan.
2005 Stock Incentive
Plan
In 2005,
Arbios Systems adopted the 2005 Stock Incentive Plan (the “2005 Plan”) for the
purpose of granting incentive stock options and/or non-statutory stock options
to employees, consultants, directors and others. The 2005 Plan was
amended to increase the shares authorized for issuance under the 2005 Plan from
3,000,000 to 4,000,000 shares at the 2007 annual shareholders
meeting. The 2005 Plan is administered by the Board of Directors of
the Company or by a committee of the Board.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
For the
years ended December 31, 2008 and 2007, the Company granted 50,000 and 0
options to consultants and recorded $2,087 and $0 expenses for the years ended
December 31, 2008 and 2007 respectively relating to the vested portion of these
options.
Stock
Options
Transactions
under the 2001 Plan during the year ended December 31, 2008 and 2007 are
summarized as follows:
|
|
For
the year ended December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
at beginning of year
|
|
|
703,000 |
|
|
$ |
1.83 |
|
|
|
982,000 |
|
|
$ |
1.88 |
|
Options
exercised
|
|
|
- |
|
|
|
|
|
|
|
(18,000 |
) |
|
|
.15 |
|
Options
forfeited
|
|
|
(88,000 |
) |
|
|
1.63 |
|
|
|
(261,000 |
) |
|
|
2.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
at end of year
|
|
|
615,000 |
|
|
$ |
1.86 |
|
|
|
703,000 |
|
|
$ |
1.83 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
exercisable at end of year
|
|
|
615,000 |
|
|
$ |
1.86 |
|
|
|
703,000 |
|
|
$ |
1.83 |
|
As of
December 31, 2008, no options were available for future grant under the 2001
Stock Option Plan.
Transactions
under the 2005 Plan during the year ended December 31, 2008 and 2007 are
summarized as follows:
|
|
For
the year ended December 31, 2008
|
|
|
For
the year ended December 31, 2007
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
at beginning of year
|
|
|
2,192,000 |
|
|
$ |
1.54 |
|
|
|
1,337,000 |
|
|
$ |
1.83 |
|
Options
issued
|
|
|
460,000 |
|
|
$ |
0
.39 |
|
|
|
1,105,000 |
|
|
$ |
0
.68 |
|
Options
forfeited
|
|
|
(1,222,000 |
) |
|
$ |
0.64 |
|
|
(250,000)
|
|
|
$ |
1.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
at end of year
|
|
|
1,430,000 |
|
|
$ |
1.51 |
|
|
|
2,192,000 |
|
|
$ |
1.26 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
exercisable at end of year
|
|
|
1,430,000 |
|
|
$ |
1.51 |
|
|
|
1,453,000 |
|
|
$ |
1.54 |
|
As of
December 31, 2008, 2,124,000 options were available for future grant under the
2005 Plan.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(8) Stockholders’
Equity Continued:
Additional
information with respect to option activity is summarized as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
Remaining
|
|
|
Average
|
|
|
|
|
|
Average
|
|
Range
of
|
|
|
|
|
|
Contractualy
|
|
|
Exercise
|
|
|
|
|
|
Exercise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
0.15
- $0.90 |
|
|
|
455,000 |
|
|
|
5.41 |
|
|
$ |
0.59 |
|
|
|
455,000 |
|
|
$ |
0.59 |
|
$ |
1.00
- $1.85 |
|
|
|
1,153,000 |
|
|
|
1.78 |
|
|
|
1.64 |
|
|
|
1,153,000 |
|
|
|
1.64 |
|
$ |
2.00
- $2.97 |
|
|
|
427,000 |
|
|
|
2.50 |
|
|
|
2.60 |
|
|
|
427,000 |
|
|
|
2.60 |
|
$ |
3.40 |
|
|
|
10,000 |
|
|
|
.32 |
|
|
|
3.40 |
|
|
|
10,000 |
|
|
|
3.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,045,000 |
|
|
|
2.73 |
|
|
|
1.62 |
|
|
|
2,045,000 |
|
|
|
1.62 |
|
The
following summarizes the activity of the Company’s non-vested stock options for
the year ended December 31, 2008.
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Non
vested at December 31, 2007
|
|
739,000
|
|
$
|
.70
|
|
Granted
|
|
460,000
|
|
|
.39
|
|
Non
vested cancellations *
|
|
(1,049,000
|
)
|
|
|
|
Vested
|
|
(150,000
|
)
|
|
.45
|
|
Non
vested at December 31, 2008
|
|
-
|
|
$
|
|
|
* July
2008 employee terminations resulted in the expiration of all unvested stock
options 90 days after termination.
(9) Income
Taxes:
The
following table presents the current and deferred tax provision for (benefit
from) federal and state income taxes for the years ended December 31, 2008 and
2007:
Current
|
|
2008
|
|
|
2007
|
|
Federal
|
|
|
- |
|
|
|
- |
|
State
|
|
|
- |
|
|
|
- |
|
Total
Current Liability
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Deferred
|
|
|
|
|
|
|
|
|
Federal
|
|
$ |
(585,000 |
) |
|
$ |
(1,599,000 |
) |
State
|
|
$ |
(41,000 |
) |
|
$ |
(496,000 |
) |
Total
Deferred Liability
|
|
$ |
(626,000 |
) |
|
$ |
(2,095,000 |
) |
|
|
|
|
|
|
|
|
|
Valuation
Allowance
|
|
$ |
626,000 |
|
|
$ |
2,095,000 |
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
- |
|
|
|
- |
|
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(9) Income Taxes
Continued:
At
December 31, 2008, components of net deferred tax assets (liabilities) in the
accompanying balance sheet include the following amounts of deferred tax
liabilities:
Deferred
Tax Assets (Liability)
|
|
2008
|
|
|
2007
|
|
Current
|
|
|
|
|
|
|
Interest
|
|
$ |
105,000 |
|
|
$ |
105,000 |
|
Intangible
|
|
|
- |
|
|
|
194,000 |
|
Patent
|
|
|
411,000 |
|
|
|
328,000 |
|
Deferred
state tax
|
|
|
(560,000 |
) |
|
|
(546,000 |
) |
Restricted
stocks
|
|
|
152,000 |
|
|
|
125,000 |
|
Stock
options
|
|
|
351,000 |
|
|
|
351,000 |
|
Other
|
|
|
36,000 |
|
|
|
74,000 |
|
Non-Current
|
|
|
|
|
|
|
|
|
NOL
|
|
|
6,868,000 |
|
|
|
6,136,000 |
|
Credits
|
|
|
256,000 |
|
|
|
231,000 |
|
Amortization
|
|
|
(137,000 |
) |
|
|
(105,000 |
) |
Depreciation
|
|
|
(6,000 |
) |
|
|
(6,000 |
) |
Net
Deferred Tax Assets
|
|
|
7,476,000 |
|
|
|
6,887,000 |
|
Less
Valuation Allowance
|
|
|
(7,476,000 |
) |
|
|
(6,887,000 |
) |
|
|
|
|
|
|
|
|
|
Net
Deferred Tax Asset (Liability)
|
|
$ |
- |
|
|
$ |
- |
|
As of
December 31, 2008, the Company has approximately $16,200,000 and $15,100,000 of
Net Operating Losses (“NOL”) for federal and state purposes, respectively, which
begin to expire between 2014 and 2028 for federal and state purposes. The
utilization of NOL carryforwards may be limited under the provisions of Internal
Revenue Code Section 382 and similar state provisions.
Section
382 of the Internal Revenue Code of 1986 generally imposes an annual limitation
on the amount of NOL carryforwards that may be used to offset taxable income
where a corporation has undergone significant changes in its stock
ownership.
The
income tax expense differs from the amounts computed by applying the United
States federal income tax rate of 34% to income taxes as a result of the
following for the years ended December 31, 2008 and 2007:
|
|
2008
|
|
|
2007
|
|
Federal
tax on pretax income at statutory rates
|
|
$ |
(771,000 |
) |
|
$ |
($1,888,000 |
) |
State
tax, net of federal benefit
|
|
|
(98,000 |
) |
|
|
(303,000 |
) |
Other
|
|
|
243,000 |
|
|
|
96,000 |
|
|
|
|
626,000 |
|
|
|
2,095,000 |
|
Total
|
|
$ |
- |
|
|
$ |
- |
|
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(10) Related
Party Transactions:
In 2003,
a Director received warrants to purchase 50,000 shares of common stock
exercisable at $1 per share as a finder’s fee.
In 2004,
the son of a Director received 7,500 shares of common stock valued at $1 per
share and warrants to purchase 7,500 shares of common stock exercisable at $2.50
per share as a finder’s fee.
In 2004,
a Director received common stock valued at $1.00 per share and warrants to
purchase 40,000 shares of common stock exercisable at $2.50 per share as a
finder’s fee.
In 2005,
a Director received cash compensation totaling $23,687 and a 5 year option to
purchase 30,000 shares of common stock at $1.80 per share for consulting
services.
In 2007,
the Company entered into a verbal agreement with AFO Advisors, LLC to provide
fundraising, strategic, and financial advisory services. Amy Factor is the
President of AFO Advisors LLC, and provides investor relations, strategic, and
management services to the Company in her current role as a director and Vice
Chairman of the Board. The Company pays AFO Advisors LLC a monthly retainer of
$12,500 pursuant to a verbal agreement and had paid a total of $87,500 in FY
2007 as well as a restricted stock grant to purchase 44,118 shares of common
stock. Additionally, Ms. Factor was granted a restricted stock grant
of 100,000 shares of common stock of which 50% of the shares would vest on
January 1, 2008 and the remaining 50% would vest on pro-rata monthly basis
during the period January 1, 2008 through June 30, 2008. In 2008, AFO
Advisors, LLC received $80,000 of consulting fees.
In
February 2008, the Company issued 25,000 shares of restricted stock to an
advisor and current member of the Board of Directors with a milestone
contingency at a price of $0.01 per share. The value of these restricted shares
issued, based on the closing price of the Company’s common stock on the date of
issuance, was expensed for $16,000 with a corresponding increase in additional
paid in capital. The milestone was not achieved, the transaction
charges were reversed and the shares were returned to treasury.
(11) Employee
Benefit Plan:
In May
2005, the Company adopted a 401K defined contribution profit-sharing plan
covering its employees. Contributions to the plan are based on
employer contributions as determined by the Company and allowable discretionary
contributions, as determined by the Company’s Board of Directors, subject to
certain limitations. Contributions by the Company to this plan
amounted to $39,972 and $23,962 for the years ended December 31, 2008 and
2007. The 401K Plan was terminated in September 2008 due to the
termination of all the employees and financial situation of the
Company.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(12) Subsequent
Events:
On March
9, 2009, (the “Effective Date") Arbios Systems, Inc. (the “Company”) entered
into a Term Sheet (the “Term Sheet”) with Arbios Acquisition Partners, LLC
(“Acquisition Partners”), a limited liability company formed for the purpose of
effecting the transaction contemplated by the Term Sheet. On March
16, 2009, the initial $100,000 deposit was received. Since January 9, 2009, the
Company has been in a proceeding under Chapter 11 of the United States
Bankruptcy Code in the United States Bankruptcy Court for the District of
Delaware (the “Bankruptcy Court”). Pursuant to the Term Sheet, the
Company agreed to enter into a transaction pursuant to a plan of reorganization
(the “Plan”) that is subject to the approval of the Bankruptcy Court and all of
the Company’s relevant classes, whereby the
Company will (i) cancel all of its currently existing equity
(including, but not limited to, any and all outstanding common and preferred
shares of stock, warrants, and options), and (ii) issue new shares of its common
stock to Acquisition Partners representing 90% of the newly issued shares of the
Company in exchange for a $1,000,000 cash payment. The existing
shareholders of the Company would receive the remaining 10% of the newly issued
shares of the Company.
The
$1,000,000 cash purchase price to be paid by Acquisition Partners for 90% of the
Company’s shares of common stock is required to be paid as follows: 1) $100,000
was paid to the Company concurrently with the execution and delivery of the Term
Sheet (the “Initial Deposit”), 2) $100,000 is due upon the later of
(i) April 8, 2009 or (ii) the filing of the Plan and the disclosure statement
(the “Subsequent Deposit”), and 3) $800,000 (the “Remaining Funds”) is due
within 10 days following the confirmation of the Plan (the “Funding
Date”).
If
Acquisition Partners has not provided the Remaining Funds by the Funding Date,
the Company will retain both the Initial Deposit and the Subsequent Deposit, and
can then either adjourn the Funding Date, withdraw the Plan, terminate the Plan,
and/or enter into an alternative transaction or proceeding. If the
Plan has not been confirmed by June 15, 2009, Acquisition Partners will be
entitled to a return of (i) the Initial Deposit, and (ii) the Subsequent Deposit
minus costs and expenses, (including, without limitation, administrative
expenses) incurred by the Company in pursuing the Plan.
Acquisition
Partners will be entitled to a break up fee of 3% of the funds deposited by
Acquisition Partners if the Company elects to enter into an alternative
transaction, including, but not limited to, signing a letter of intent or term
sheet with a third party, for some or all of its assets prior to confirmation of
the Plan (the “Company Withdrawal Option”), provided that the Debtor Withdrawal
Option is not caused by Acquisition Partner’s inability to provide funding by
the Funding Date. In addition, if the Company exercises the Debtor
Withdrawal Option, Acquisition Partners would also be entitled to a return of
the funded portion of the deposit.
ARBIOS
SYSTEMS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2008 AND 2007
(12) Subsequent
Events continued:
The
Company intends to continue to comply with all of its regulatory filings with
the Securities and Exchange Commission and expects that its shares of common
stock will continue to be listed on the OTC Bulletin
Board. Accordingly, after the completion of the transaction
contemplated by the Term Sheet, the Company is expected to emerge from
bankruptcy as a publicly traded company that has no liabilities (other than
ordinary operating expenses), has a new capital structure (Acquisition Partners
will own 90% of the common stock, the public stockholders will own a pro rata share of the 10%,
and all options and warrants will be cancelled), and has some operating capital
(the amount of the $1,000,000 purchase price that is not used to settle existing
liabilities and pay for administrative expenses). The Term Sheet provides that
the confirmation of the Plan should occur on or before May 15,
2009.
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
ARBIOS
SYSTEMS, INC.
|
|
|
|
|
|
|
By:
|
/s/ SHAWN P. CAIN
|
|
|
|
Shawn
P. Cain, Interim President and
Chief
Executive Officer
|
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/
SHAWN P. CAIN |
|
Interim
President and Chief Executive Officer |
|
April
15, 2009
|
Shawn
P. Cain
|
|
(principal
executive officer)
|
|
|
|
|
|
|
|
/s/ SCOTT L.
HAYASHI
|
|
Interim
Chief Financial Officer (principal financial officer |
|
April
15, 2009
|
Scott
L. Hayashi
|
|
and
principal accounting officer)
|
|
|
|
|
|
|
|
/s/ JOHN M.VIERLING, MD |
|
Chairman
of the Board, and Director
|
|
April
15, 2009 |
John
M. Vierling, MD
|
|
|
|
|
|
|
|
|
|
/s/ AMY FACTOR
|
|
Vice
Chairman of the Board, and Director
|
|
April
15, 2009
|
Amy
Factor |
|
|
|
|
|
|
|
|
|
/s/ JACK E.
STOVER
|
|
Director
|
|
April
15, 2009
|
Jack
E. Stover
|
|
|
|
|
|
|
|
|
|
/s/ THOMAS C. SEOH
|
|
Director
|
|
April
15, 2009
|
Thomas
C. Seoh
|
|
|
|
|
|
|
|
|
|
/s/ THOMAS M. TULLY
|
|
Director
|
|
April
15, 2009
|
Thomas
M. Tully
|
|
|
|
|
|
|
|
|
|
/s/ DENNIS L. KOGOD
|
|
Director
|
|
April
15, 2009
|
Dennis
L. Kogod
|
|
|
|
|
INDEX
TO EXHIBITS
Exhibit Number
|
|
Description
|
2.1
|
|
Agreement
and Plan of Reorganization, dated October 20, 2003, by and among
Historical Autographs U.S.A., Inc., Arbios Technologies, Inc., HAUSA
Acquisition, Inc., Cindy K. Swank and Raymond J. Kuh
(1)
|
|
|
|
2.2+
|
|
Debtor
In Possession’s Application For An Order Conditionally Approving The Plan
As The Disclosure Statement, filed by Arbios Systems, Inc. on April 3,
2009 in the United States Bankruptcy Court For The District Of Delaware
pursuant to the provisions of Chapter 11 of the Bankruptcy
Code
|
|
|
|
3.1
|
|
Certificate
of Incorporation of Arbios Systems, Inc. dated June 3, 2005
(7)
|
|
|
|
3.2
|
|
Certificate
of Correction of Arbios Systems, Inc. dated on July 6, 2005
(7)
|
|
|
|
3.3
|
|
Certificate
of Ownership and Merger dated July 25, 2005 (7)
|
|
|
|
3.4
|
|
Certificate
of Ownership and Merger dated July 26, 2005 (7)
|
|
|
|
3.5
|
|
Bylaws
of Arbios Systems, Inc. (7)
|
|
|
|
4.1
|
|
Form
of Common Stock certificate (7)
|
|
|
|
4.2
|
|
Form
of Common Stock Purchase Warrant (3)
|
|
|
|
4.3
|
|
Common
Stock Purchase Warrant dated April 1, 2004 (4)
|
|
|
|
4.4
|
|
Form
of Warrant to Purchase Common Stock dated January 11, 2005
(5)
|
|
|
|
4.5
|
|
Common
Stock Purchase Warrant dated March 29, 2007 (8)
|
|
|
|
10.1*
|
|
2001
Stock Option Plan (2)
|
|
|
|
10.2
|
|
License
Agreement, entered into as of June 2001, by and between Cedars-Sinai
Medical Center and Arbios Technologies, Inc. (3)
|
|
|
|
10.3
|
|
License
Agreement, dated December 26, 2001, by and between Spectrum Laboratories,
Inc. and Arbios Technologies, Inc. (3)
|
|
|
|
10.4
|
|
Asset
Purchase Agreement among Circe Biomedical, Inc., Arbios Technologies,
Inc., and Arbios Systems, Inc., dated as of April 7, 2004
(4)
|
|
|
|
10.5
|
|
Manufacturing
and Supply Agreement, dated as of December 26, 2001, between Spectrum
Laboratories, Inc. and Arbios Technologies, Inc. (4)
|
|
|
|
10.6
|
|
Research
Agreement, dated as of December 26, 2001, between Spectrum Laboratories,
Inc. and Arbios Technologies, Inc. (4)
|
|
|
|
10.7
|
|
First
Amendment to Research Agreement, dated as of October 14, 2002, between
Spectrum Laboratories, Inc. and Arbios Technologies, Inc.
(4)
|
10.8
|
|
Form
of Purchase Agreement, dated as of January 11, 2005, by and among Arbios
Systems, Inc. and the Investors named therein (5)
|
|
|
|
10.9
|
|
Form
of Registration Rights Agreement, dated as of January 11, 2005, by and
among Arbios Systems, Inc. and the Investors named therein
(5)
|
|
|
|
10.10
|
|
Omnibus
Stockholders’ Agreement, dated as of October 24, 2003, by and among Arbios
Technologies, Inc., Historical Autographs U.S.A., Inc., Spectrum
Laboratories, Inc., Cedars-Sinai Medical Center, Achilles A. Demetriou,
M.D., Ph.D. and Kristin P. Demetriou, as Trustees of the A & K
Demetriou Family Trust created on November 13, 2000, and Jacek Rozga,
M.D., Ph.D. and Joanna Rozga(18)
|
|
|
|
10.11*
|
|
Employment
Offer Letter, dated March 25, 2005, between Arbios Systems, Inc. and Shawn
Cain (7)
|
|
|
|
10.12*
|
|
Employment
Offer Letter, dated March 29, 2005, between Arbios Systems, Inc. and Scott
Hayashi (7)
|
|
|
|
10.13*
|
|
2005
Stock Incentive Plan (6)
|
|
|
|
10.14*
|
|
Form
of Stock Option Agreement for the 2005 Stock Incentive Plan
(6)
|
|
|
|
10.15
|
|
License
Agreement, dated March 29, 2007, between Arbios Systems, Inc. and
Immunocept, LLC (8) (12)
|
|
|
|
10.16
|
|
Purchase
Agreement, dated April 23, 2007, by and among Arbios Systems, Inc. and the
Investors set forth on the signature pages affixed thereto
(9).
|
|
|
|
10.17
|
|
Registration
Rights Agreement, dated April 23, 2007, by and among Arbios Systems, Inc.
and the Investors named herein (9).
|
|
|
|
10.18
|
|
Form
of Warrant A to Purchase Common Stock dated April 23, 2007
(9)
|
|
|
|
10.19
|
|
Form
of Warrant B to Purchase Common Stock dated April 23, 2007
(9)
|
|
|
|
10.20
|
|
Offer
Letter of Dr. Jacek Rozga dated April 26, 2007 (10)
|
|
|
|
10.21
|
|
Certificate
of Amendment of Certificate of Incorporation of Arbios Systems, Inc. dated
July 13, 2007 (11)
|
|
|
|
10.22
|
|
Supply
Agreement by and between Membrana GmbH and Arbios Systems, Inc. dated
September 14, 2007 (11)
|
|
|
|
10.23
|
|
Lease
Agreement by and between Cummings Properties, LLC and Arbios Systems, Inc.
dated September 15, 2007 (11)
|
|
|
|
10.24
|
|
Consulting
Agreement by and between David Zeffren and Arbios Systems, Inc. dated
November 8, 2007 (11)
|
|
|
|
10.25
|
|
Separation
Agreement by and between Walter C. Ogier and Arbios Systems, Inc. dated
November 13, 2007 (11)
|
10.26
|
|
Manufacturing
& Supply Agreement by and between NxStage Medical, Inc. and Arbios
Systems, Inc. dated October 19, 2007 (12)(18).
|
|
|
|
10.27*
|
|
Consulting
Agreement, dated August 1, 2008, between the Company and Shawn P. Cain
(15)
|
|
|
|
10.28*
|
|
Consulting
Agreement, dated August 1, 2008, between the Company and Scott Hayashi
(15)
|
|
|
|
10.29
|
|
Asset
Purchase Agreement, dated October 3, 2008, between Arbios Systems, Inc,
and HepaLife Technologies, Inc. (16)
|
|
|
|
10.30*
|
|
Compensation
Agreement between Arbios Systems, Inc. and Shawn Cain
(16)
|
|
|
|
10.31*
|
|
Compensation
Agreement between Scott Hayashi and Arbios Systems, Inc., dated November
10, 2008 (17)
|
|
|
|
31.1+
|
|
Certification
of Principal Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
|
|
31.2+
|
|
Certification
of Principal Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
|
|
32.1+
|
|
Certification
of Principal Executive Officer Pursuant to 18 U.S.C. Section
1350
|
|
|
|
32.2+
|
|
Certification
of Principal Financial Officer Pursuant to 18 U.S.C. Section
1350
|
+ Filed
herewith.
* Denotes
a management contract or compensatory plan or arrangement.
(1)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 14, 2003, which exhibit
is hereby incorporated herein by
reference.
|
(2)
|
Previously
filed as an exhibit to the Company’s Registration Statement on Form 10-SB
filed with the Securities and Exchange Commission on April 26, 2001, which
exhibit is hereby incorporated herein by
reference.
|
(3)
|
Previously
filed as an exhibit to the Company’s Annual Report on Form 10-KSB filed
with the Securities and Exchange Commission on March 30, 2004, which
exhibit is hereby incorporated herein by
reference.
|
(4)
|
Previously
filed as an exhibit to the Company’s Registration Statement on Form SB-2/A
filed with the Securities and Exchange Commission on September 10, 2004,
which exhibit is hereby incorporated herein by
reference.
|
(5)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on January 14, 2005, which exhibit
is hereby incorporated herein by
reference.
|
(6)
|
Previously
filed as an exhibit to the Company’s Quarterly Report on Form S-8 filed
with the Securities and Exchange Commission on August 31, 2005, which
exhibit is hereby incorporated herein by
reference.
|
(7)
|
Previously
filed as an exhibit to the Company’s Form 10-KSB filed with the Securities
and Exchange Commission on March 31, 2006, which exhibit is hereby
incorporated herein by reference.
|
(8)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on April 4,
2007.
|
(9)
|
Previously
filed as the corresponding exhibit to the Company’s Current Report on Form
8-K filed with the Securities and Exchange Commission on April 27, 2007,
which exhibit is hereby incorporate herein by
reference.
|
(10)
|
Previously
filed as the corresponding exhibit to the Company’s Current Report on Form
8-K filed with the Securities and Exchange Commission on May 3, 2007,
which exhibit is hereby incorporate herein by
reference.
|
(11)
|
Previously
filed as an exhibit to the Company’s Form 10-QSB filed with the Securities
and Exchange Commission on November 14,
2007.
|
(12)
|
Portions
of this exhibit have been omitted and filed separately with the Secretary
of the Securities and Exchange Commission pursuant to a confidential
treatment request.
|
(13)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on February 15,
2008.
|
(14)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on May 12,
2008.
|
(15)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on August 6,
2008.
|
(16)
|
Previously
filed as an exhibit to the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on October 7,
2008.
|
(17)
|
Previously
filed as an exhibit to the Company’s Form 10-Q filed with the Securities
and Exchange Commission on November 14, 2008, which exhibit is hereby
incorporated herein by reference.
|
(18)
|
Previously
filed as an exhibit to the Company’s Annual Report on Form 10-KSB filed
with the Securities and Exchange Commission on March 31, 2008, which
exhibit is hereby incorporated herein by
reference.
|