x |
ANNUAL
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
o |
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
Delaware
(State
or other jurisdiction of
incorporation
or organization)
|
91-1955323
(I.R.S.
Employer
Identification
No.)
|
1050
Winter Street, Suite 1000,
Waltham,
MA
(Address
of principal executive offices)
|
02451
(Zip
Code)
|
Part
I
|
||||
1.
|
Description
of Business
|
1
|
||
2.
|
Description
of Property
|
20
|
||
3.
|
Legal
Proceedings
|
21
|
||
4.
|
Submission
of Matters to a Vote of Security Holders
|
21
|
||
Part
II
|
||||
5.
|
Market
for Common Equity and Related Stockholder Matters and
Small Business
Issuer
Purchases of Equity Securities
|
21
|
||
6.
|
Management’s
Discussion and Analysis or Plan of Operation
|
22
|
||
7.
|
Financial
Statements
|
38
|
||
8.
|
Changes
In and Disagreements With Accountants on Accounting and Financial
Disclosure
|
39
|
||
8A.
|
Controls
and Procedures
|
39
|
||
8B.
|
Other
Information
|
39
|
||
Part
III
|
||||
9.
|
Directors,
Executive Officers, Promoters and Control Persons; Compliance with
Section 16(a) of the Exchange Act
|
40
|
||
10.
|
Executive
Compensation
|
44
|
||
11.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
50
|
||
12.
|
Certain
Relationships and Related Transactions
|
54
|
||
13.
|
Exhibits
|
54
|
||
14.
|
Principal
Accountant Fees and Services
|
57
|
Three
months
|
Three
months
|
Six
months
|
Three
months
|
Nine
months
|
||||||||||||
ended
|
ended
|
ended
|
ended
|
ended
|
||||||||||||
March
31, 2006
|
June
30, 2006
|
June
30, 2006
|
Sept.
30, 2006
|
Sept.
30, 2006
|
||||||||||||
Net
loss
|
||||||||||||||||
As
originally reported
|
$
|
(1,069,468
|
)
|
$
|
(837,202
|
)
|
$
|
(1,906,670
|
)
|
$
|
(1,081,410
|
)
|
$
|
(2,988,080
|
)
|
|
Adjustment
|
(63,000
|
)
|
(63,000
|
)
|
(49,000
|
)
|
(112,000
|
)
|
||||||||
As
adjusted
|
$
|
(1,069,468
|
)
|
$
|
(900,202
|
)
|
$
|
(1,969,670
|
)
|
$
|
(1,130,410
|
)
|
$
|
(3,100,080
|
)
|
|
Accrued
warrant liability
|
||||||||||||||||
As
originally reported
|
$
|
680,841
|
$
|
407,717
|
$
|
524,172
|
||||||||||
Adjustment
|
271,000
|
334,000
|
497,000
|
|||||||||||||
As
adjusted
|
$
|
951,841
|
$
|
741,717
|
$
|
1,021,172
|
||||||||||
Additional
paid-in capital
|
||||||||||||||||
As
originally reported
|
$
|
14,190,980
|
$
|
14,296,357
|
$
|
14,307,052
|
||||||||||
Adjustment
|
(271,000
|
)
|
(271,000
|
)
|
(385,000
|
)
|
||||||||||
As
adjusted
|
$
|
13,919,980
|
$
|
14,025,357
|
$
|
13,922,052
|
(1) |
FDA-authorized
standard operating procedures.
These are standard operating procedures for production of porcine
cells
including harvesting, freezing, storing, shipping and processing
by the
end user (thawing, washing) of the cells. These procedures and protocols
have been reviewed by the FDA for use in a pivotal phase clinical
trial.
|
(2) |
The
cartridge to be used in the Phase III trial of
HepatAssistTM.
We intend to use the existing, FDA-approved cartridge housing, and
we have
obtained FDA authorization to increase the number of porcine hepatocyte
cells that the cartridge would contain, which increase we believe
will
improve the functionality of the system with no adverse impact on
safety.
|
(3) |
An
FDA reviewed, authorized Phase III protocol acquired from Circe
Biomedical.
We will likely further modify this protocol, according to the
retrospective analysis of the original Phase II-III clinical trial
published in the Annals
of Surgery
in
2004 (by A.A. Demetriou et al), and submit the modified protocol
to the
FDA for approval.
|
(4) |
The
HepatAssistTM
perfusion instrument platform.
The HepatAssist™ perfusion platform is Circe Biomedical’s specially
designed machine that pumped the patient’s plasma through the cartridge.
This machine was used in the Phase II/III trial of
HepatAssist™.
|
· |
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
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
hospital stay; and
|
· |
reduce
the cost of care.
|
·
|
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™. They 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™.
|
(1)
|
A
bioartificial liver system in which liver cell therapy and blood
detoxification are integrated in a single fiber-in-fiber module
(US Patent
# 6,582,955 B2 for “Bioreactor With Application as Blood Therapy Device”
issued in June 2003). We have licensed this patent from Spectrum
Laboratories.
|
(2)
|
Semi-automated
large-scale liver cell procurement technology (US Patent #5,888,409
for
“Methods for Cell Isolation and Collection” issued on March 30,
1999). We licensed this patent from Cedars-Sinai Medical
Center.
|
(3)
|
Liver
cell procurement technology (US Patent #5,968,356 for “System for
Hepatocyte Cell Isolation and Collection” issued on October 19, 1999, and
related European Patent #0 830 099 for “Apparatus and Method for Cell
Isolation and Collection”). We licensed this patent from Cedars-Sinai
Medical Center.
|
(4)
|
Liver
cell cryopreservation technology (US Patent #6,140,123 for “Method for
Conditioning and Cryopreserving Cells” issued on October 31, 2000).
We licensed this patent from Cedars-Sinai Medical
Center.
|
(1)
|
Apparatus
for Bioprocessing a Circulating Fluid. US Patent #5643794 (issued
on July
1, 1997).
|
(2)
|
Cryopreserved
Hepatocytes and High Viability and Metabolic Activity. US Patent
#5795711
(issued on August 18, 1998).
|
(3)
|
Closed
System for Processing Cells. US Patent #5858642 (issued on January
12,
1999).
|
(4)
|
Cell
Innoculation Device. US Patent #5,891,713 (issued on April 6, 1999).
|
(5)
|
Method
of Thawing Cryopreserved Cells. US Patent #5895745 (issued on April
20,
1999).
|
(6)
|
High
Flow Technique for Harvesting Mammalian Cells. US Patent #5912163
(issued
on June 15, 1999).
|
(7)
|
Removal
of Agent From Cell Suspension. US Patent #6068775 (issued on May
30,
2000).
|
(8)
|
Method
for Cryopreserving Hepatocytes. US Patent #6136525 (issued on October
24,
2000).
|
Patent
No.
|
Country
|
Title
of Patent Application
|
||
515326/97
|
JP
|
Cryopreserved
Hepatocytes & High Viability and Metabolic
Activity
|
Quarter
Ending
|
High
|
Low
|
|||||
March
31, 2005
|
$
|
1.66
|
$
|
1.60
|
|||
June
30, 2005
|
$
|
2.20
|
$
|
2.10
|
|||
September
30, 2005
|
$
|
1.90
|
$
|
1.80
|
|||
December
31, 2005
|
$
|
1.80
|
$
|
1.74
|
|||
March
31, 2006
|
$
|
1.85
|
$
|
0.65
|
|||
June
30, 2006
|
$
|
1.25
|
$
|
0.90
|
|||
September
30, 2006
|
$
|
0.92
|
$
|
0.42
|
|||
December
31, 2006
|
$
|
0.79
|
$
|
0.46
|
Three
months
|
Three
months
|
Six
months
|
Three
months
|
Nine
months
|
||||||||||||
ended
|
ended
|
ended
|
ended
|
ended
|
||||||||||||
March
31, 2006
|
June
30, 2006
|
June
30, 2006
|
Sept.
30, 2006
|
Sept.
30, 2006
|
||||||||||||
Net
loss
|
||||||||||||||||
As
originally reported
|
$
|
(1,069,468
|
)
|
$
|
(837,202
|
)
|
$
|
(1,906,670
|
)
|
$
|
(1,081,410
|
)
|
$
|
(2,988,080
|
)
|
|
Adjustment
|
(63,000
|
)
|
(63,000
|
)
|
(49,000
|
)
|
(112,000
|
)
|
||||||||
As
adjusted
|
$
|
(1,069,468
|
)
|
$
|
(900,202
|
)
|
$
|
(1,969,670
|
)
|
$
|
(1,130,410
|
)
|
$
|
(3,100,080
|
)
|
|
Accrued
warrant liability
|
||||||||||||||||
As
originally reported
|
$
|
680,841
|
$
|
407,717
|
$
|
524,172
|
||||||||||
Adjustment
|
271,000
|
334,000
|
497,000
|
|||||||||||||
As
adjusted
|
$
|
951,841
|
$
|
741,717
|
$
|
1,021,172
|
||||||||||
Additional
paid-in capital
|
||||||||||||||||
As
originally reported
|
$
|
14,190,980
|
$
|
14,296,357
|
$
|
14,307,052
|
||||||||||
Adjustment
|
(271,000
|
)
|
(271,000
|
)
|
(385,000
|
)
|
||||||||||
As
adjusted
|
$
|
13,919,980
|
$
|
14,025,357
|
$
|
13,922,052
|
Contractual
Obligations
|
Total
|
|
2007
|
|
2008
and
thereafter
|
|||||
Short-Term
Office Leases
|
$
|
107,000
|
$
|
107,000
|
$
|
-0-
|
·
|
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.
|
· |
announcements
of the results of clinical trials by us or our
competitors,
|
· |
developments
with respect to patents or proprietary
rights,
|
· |
announcements
of technological innovations by us or our
competitors,
|
· |
announcements
of new products or new contracts by us or our
competitors,
|
· |
actual
or anticipated variations in our operating results due to the level
of
development expenses and other
factors,
|
· |
changes
in financial estimates by securities analysts and whether our earnings
meet or exceed such estimates,
|
· |
conditions
and trends in the pharmaceutical and other
industries,
|
· |
new
accounting standards,
|
· |
general
economic, political and market conditions and other factors, and
the
occurrence of any of the risks described in this Annual
Report.
|
Independent
Registered Public Accounting Firm Report
|
F-1
|
Balance
Sheet - As of December 31, 2006 and 2005
|
F-2
|
Statement
of Operations - For the Years Ended December 31, 2006,
2005
|
|
and
Period From August 23, 2000 (Inception) to December 31,
2006
|
F-3
|
Statement
of Cash Flows - For the Years Ended December 31, 2006,
2005
|
|
and
Period From August 23, 2000 (Inception) to December 31,
2006
|
F-4
|
Statements
of Change in Stockholders’ Equity - For the Years Ended
|
|
F-5
|
|
Notes
to Financial Statements
|
F-9
|
December
31,
|
|
||||||
|
|
2006
|
|
2005
|
|||
ASSETS
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
2,054,280
|
$
|
2,379,738
|
|||
Short
term investments
|
-
|
1,996,000
|
|||||
Prepaid
expenses
|
147,163
|
195,841
|
|||||
Total
current assets
|
2,201,443
|
4,571,579
|
|||||
Net
property and equipment
|
73,110
|
101,629
|
|||||
Patent
rights, net of accumulated amortization of $113,894 and $93,418,
respectively
|
152,773
|
173,249
|
|||||
Other
assets
|
62,827
|
55,773
|
|||||
Total
assets
|
$
|
2,490,153
|
$
|
4,902,230
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable
|
$
|
310,162
|
$
|
160,649
|
|||
Accrued
expenses
|
132,073
|
152,362
|
|||||
Total
current liabilities
|
442,235
|
313,011
|
|||||
Accrued
warrant liability
|
763,654
|
-
|
|||||
Stockholders'
equity
|
|||||||
Preferred
stock, $.001 par value; 5,000,000 shares authorized:
|
|||||||
none
issued and outstanding
|
-
|
-
|
|||||
Common
stock, $.001 par value; 60,000,000 shares authorized; 17,460,181
and
16,232,909
|
|||||||
shares
issued and outstanding at December 31, 2006 and 2005
respectively
|
17,460
|
16,233
|
|||||
Additional
paid-in capital
|
14,507,939
|
13,352,217
|
|||||
Deficit
accumulated during the development stage
|
(13,241,135
|
)
|
(8,779,231
|
)
|
|||
Total
stockholders' equity
|
1,284,264
|
4,589,219
|
|||||
Total
liabilities and stockholders' equity
|
$
|
2,490,153
|
$
|
4,902,230
|
For
the years ended
December 31, |
Inception
to
|
|||||||||
2006
|
2005
|
December
31, 2006
|
||||||||
Revenues
|
$
|
-
|
$
|
-
|
$
|
320,966
|
||||
Operating
expenses:
|
||||||||||
General
and administrative
|
3,315,174
|
2,394,546
|
8,322,089
|
|||||||
Research
and development
|
1,822,614
|
1,554,509
|
5,813,176
|
|||||||
Total
operating expenses
|
5,137,788
|
3,949,055
|
14,135,265
|
|||||||
Loss
before other income (expense)
|
(5,137,788
|
)
|
(3,949,055
|
)
|
(13,814,299
|
)
|
||||
Other
income (expense):
|
||||||||||
Change
in fair value of warrant liability
|
521,187
|
-
|
521,187
|
|||||||
Interest
income
|
154,697
|
125,286
|
296,115
|
|||||||
Interest
expense
|
-
|
(134
|
)
|
(244,138
|
)
|
|||||
Total
other income (expense)
|
675,884
|
125,152
|
573,164
|
|||||||
Net
loss
|
$
|
(4,461,904
|
)
|
$
|
(3,823,903
|
)
|
$
|
(13,241,135
|
)
|
|
Net
loss per share:
|
||||||||||
Basic
and diluted
|
$
|
(0.26
|
)
|
$
|
(0.24
|
)
|
||||
Weighted-average
shares:
|
||||||||||
Basic
and diluted
|
17,244,988
|
16,137,676
|
For
the year ended December 31,
|
Inception
to
|
|||||||||
2006
|
2005
|
December
31, 2006
|
||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$ | (4,461,904 | ) | $ |
(3,823,903
|
) | $ | (13,241,135 | ) | |
Adjustments
to reconcile net loss to net cash
|
||||||||||
used
in operating activities:
|
||||||||||
Amortization
of debt discount
|
-
|
-
|
244,795
|
|||||||
Depreciation
and amortization
|
52,442
|
59,249
|
252,219
|
|||||||
Change
in fair value of warrant liability
|
(521,187
|
)
|
-
|
(521,187
|
)
|
|||||
Patent
rights impairment
|
-
|
91,694
|
91,694
|
|||||||
Interest
earned on discounted short term investments
|
8,652
|
(8,652
|
)
|
-
|
||||||
Issuance
of common stock, options & warrants for compensation
|
1,186,803
|
557,079
|
2,799,934
|
|||||||
Settlement
of accrued expense
|
-
|
-
|
54,401
|
|||||||
Deferred
compensation costs
|
-
|
-
|
319,553
|
|||||||
Changes
in operating assets and liabilities:
|
||||||||||
Prepaid
expenses
|
48,678
|
(98,188
|
)
|
(147,165
|
)
|
|||||
Other
assets
|
(7,054
|
)
|
(22,609
|
)
|
(62,827
|
)
|
||||
Accounts
payable and accrued expenses
|
129,224
|
34,552
|
348,733
|
|||||||
Other
liabilities
|
-
|
64,695
|
64,695
|
|||||||
Contract
obligation
|
-
|
(250,000
|
)
|
-
|
||||||
Net
cash provided by operating activities
|
(3,564,346
|
)
|
(3,396,083
|
)
|
(9,796,290
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Additions
of property and equipment
|
(3,447
|
)
|
(23,489
|
)
|
(144,796
|
)
|
||||
Purchase
of short term investments
|
(12,889,073
|
)
|
(8,977,714
|
)
|
(21,866,787
|
)
|
||||
Maturities
of short term investments
|
14,876,421
|
6,990,366
|
21,866,787
|
|||||||
Net
cash provided by and (used in) investing activities
|
1,983,901
|
(2,010,837
|
)
|
(144,796
|
)
|
|||||
Cash
flows from financing activities:
|
||||||||||
Proceeds
from issuance of convertible debt
|
-
|
-
|
400,000
|
|||||||
Proceeds
from common stock option/warrant exercise
|
-
|
62,500
|
65,200
|
|||||||
Net
proceeds from issuance of common stock and warrants
|
1,254,987
|
6,227,594
|
11,313,249
|
|||||||
Net
proceeds from issuance of preferred stock
|
-
|
-
|
238,732
|
|||||||
Payments
on capital lease obligation, net
|
-
|
(5,341
|
)
|
(21,815
|
)
|
|||||
Net
cash provided by financing activities
|
1,254,987
|
6,284,753
|
11,995,366
|
|||||||
Net
(decrease) increase in cash
|
(325,458
|
)
|
877,833
|
2,054,280
|
||||||
Cash
at beginning of period
|
2,379,738
|
1,501,905
|
-
|
|||||||
Cash
at end of period
|
$
|
2,054,280
|
$
|
2,379,738
|
$
|
2,054,280
|
||||
Supplemental
disclosures of non-cash financing activity
|
||||||||||
Issuance
of securities for obligation related to finder's fees
|
-
|
-
|
$
|
47,500
|
||||||
Accrued
warrant liability
|
$
|
763,654
|
-
|
$
|
763,654
|
Deficit
|
|||||||||||||||||||||||||
Accumulated
|
|||||||||||||||||||||||||
Additional
|
During
the
|
||||||||||||||||||||||||
Preferred
Stock
|
Common
Stock
|
Paid-In
|
Deferred
|
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
|
Deficit
|
|||||||||||||||||||||||||
Accumulated
|
|||||||||||||||||||||||||
Additional
|
During
the
|
||||||||||||||||||||||||
Preferred
Stock
|
Common
Stock
|
Paid-In
|
Deferred
|
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
|
)
|
-
|
Deficit
|
|||||||||||||||||||||||||
Accumulated
|
|||||||||||||||||||||||||
Additional
|
During
the
|
||||||||||||||||||||||||
Preferred
Stock
|
Common
Stock
|
Paid-In
|
Deferred
|
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
|
Deficit
|
|||||||||||||||||||||||||
Accumulated
|
|||||||||||||||||||||||||
Additional
|
During
the
|
||||||||||||||||||||||||
Preferred
Stock
|
Common
Stock
|
Paid-In
|
Deferred
|
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
|
(1) |
Summary
of Significant Accounting
Policies:
|
(1) |
Summary
of Significant Accounting Policies,
Continued:
|
(1)
|
Summary
of Significant Accounting Policies,
Continued:
|
(1)
|
Summary
of Significant Accounting Policies,
Continued:
|
Year
ended
|
||||
December
31, 2005
|
||||
Net
loss as reported
|
$
|
(3,823,903
|
)
|
|
|
||||
Compensation
recognized under:
|
||||
SFAS
123
|
(984,514
|
)
|
||
Pro
forma net loss
|
$
|
(4,808,417
|
)
|
|
Basic
and diluted loss per common share:
|
||||
As
reported
|
$
|
(0.24
|
)
|
|
Pro
forma
|
$
|
(0.30
|
)
|
For
the Year Ended
December 31 , |
|||||||
2006
|
2005
|
||||||
Weighted
average of fair value at date of grant for
options
granted during the period
|
$
|
0.87
|
$
|
1.31
|
|||
Risk-free
interest rates
|
4.35%
- 5.04
|
%
|
3.77%
- 4.45
|
%
|
|||
Expected
option life in years
|
7
|
5-7
|
|||||
Expected
stock price volatility
|
.72
- .77
|
.83
- .72
|
|||||
Expected
dividend yield
|
-
|
-
|
(1)
|
Summary
of Significant Accounting Policies
Continued:
|
(1)
|
Summary
of Significant Accounting Policies
Continued:
|
(2) |
Property
and Equipment:
|
2006
|
2005
|
||||||
Office
equipment
|
$
|
8,589
|
$
|
8,589
|
|||
Office
furniture
|
7,297
|
7,297
|
|||||
Computer
equipment
|
45,915
|
42,468
|
|||||
Medical
equipment
|
107,993
|
107,993
|
|||||
169,794
|
166,347
|
||||||
Less:
accumulated depreciation
|
(96,684
|
)
|
(64,718
|
)
|
|||
$
|
73,110
|
$
|
101,629
|
(3) |
Patent
Rights:
|
(3) |
Patent
Rights Continued:
|
(4) |
Deferred
Employee Loan-Out Costs:
|
(5) |
Convertible
Promissory Notes:
|
(5) |
Convertible
Promissory Notes
Continued:
|
(6) |
Commitments
and Contingencies:
|
(6)
|
Commitments
and Contingencies
Continued:
|
(7)
|
Stockholders’
Equity:
|
(7)
|
Stockholders’
Equity, Continued:
|
(7)
|
Stockholders’
Equity, Continued:
|
(7) |
Stockholders’
Equity, Continued:
|
(7) |
Stockholders’
Equity, Continued:
|
(7) |
Stockholders’
Equity, Continued:
|
(7) |
Stockholders’
Equity, Continued:
|
Number
of
|
Exercise
|
||||||
Shares
|
Price
|
Expiration
date
|
|||||
100,000
|
$
|
0.15
|
August
18, 2009
|
||||
900,000
|
1.00
|
February
15, 2007
|
|||||
50,000
|
1.00
|
July
3, 2008
|
|||||
4,375,000
|
2.50
|
October
29, 2008
|
|||||
47,500
|
2.50
|
January
5, 2007
|
|||||
75,000
|
3.40
|
April
1, 2009
|
|||||
50,000
|
1.50
|
August
4, 2009
|
|||||
50,000
|
3.50
|
August
4, 2009
|
|||||
200,000
|
2.90
|
February
1, 2010
|
|||||
1,704,343
|
2.74
|
January
11, 2010
|
|||||
613,634
|
1.50
|
March
6, 2011
|
|||||
8,165,477
|
(7)
|
Stockholders’
Equity, Continued:
|
For
the year ended December 31,
|
|||||||||||||
2006
|
2005
|
||||||||||||
Weighted
|
Weighted
|
||||||||||||
Average
|
Average
|
||||||||||||
Shares
|
Price
|
Shares
|
Price
|
||||||||||
Warrants
at beginning of year
|
7,457,810
|
$
|
2.30
|
5,672,500
|
$
|
2.11
|
|||||||
Warrants
issued
|
707,667
|
$
|
1.66
|
1,810,310
|
$
|
2.90
|
|||||||
Warrants
exercised
|
(25,000
|
)
|
$
|
2.50
|
|||||||||
Warrants
forfeited
|
|
|
|||||||||||
Warrants
at end of year (2)
|
8,165,477
|
$
|
2.29
|
(1)
|
7,457,810
|
$
|
2.30
|
(7)
|
Stockholders’
Equity, Continued:
|
For
the year ended December 31,
|
|||||||||||||
2006
|
2005
|
||||||||||||
Weighted
|
Weighted
|
||||||||||||
Average
|
Average
|
||||||||||||
Shares
|
Price
|
Shares
|
Price
|
||||||||||
Options
at beginning of year
|
982,000
|
$
|
1.88
|
731,000
|
$
|
1.79
|
|||||||
Options
issued
|
266,000
|
$
|
2.12
|
||||||||||
Options
exercised
|
|||||||||||||
Options
forfeited
|
-
|
(15,000
|
)
|
$
|
2.25
|
||||||||
Options
at end of year
|
982,000
|
$
|
1.88
|
982,000
|
$
|
1.88
|
|||||||
Options
exercisable at end of year
|
978,000
|
$
|
1.87
|
935,000
|
$
|
1.87
|
For
the year ended
December 31, 2006 |
For
the year ended
December 31, 2005 |
||||||||||||
Weighted
|
Weighted
|
||||||||||||
Average
|
Average
|
||||||||||||
Shares
|
Price
|
Shares
|
Price
|
||||||||||
Options
at beginning of year
|
905,000
|
$
|
1.98
|
-
|
-
|
||||||||
Options
issued
|
432,000
|
$
|
1.25
|
910,000
|
$
|
1.98
|
|||||||
Options
exercised
|
|||||||||||||
Options
forfeited
|
|
(5,000
|
)
|
$
|
1.80
|
||||||||
Options
at end of year
|
1,337,000
|
$
|
1.75
|
905,000
|
$
|
1.98
|
|||||||
Options
exercisable at end of year
|
1,003,000
|
$
|
1.83
|
284,000
|
$
|
2.17
|
(7)
|
Stockholders’
Equity, Continued:
|
December
31, 2006
|
||||||||||||||||
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||
Weighted
|
||||||||||||||||
Average
|
Weighted
|
Weighted
|
||||||||||||||
Remaining
|
Average
|
Average
|
||||||||||||||
Range
of
|
Contractually
|
Exercise
|
Exercise
|
|||||||||||||
Exercise
Prices
|
Shares
|
(in
years)
|
Price
|
Shares
|
Price
|
|||||||||||
$0.15
- $0.90
|
276,000
|
6.45
|
$
|
0.73
|
154,000
|
$
|
0.63
|
|||||||||
$1.00
- $1.85
|
1,327,000
|
3.77
|
1.59
|
1,111,000
|
1.54
|
|||||||||||
$2.00
- $2.97
|
706,000
|
4.51
|
2.59
|
706,000
|
2.59
|
|||||||||||
$3.40
|
10,000
|
2.32
|
3.40
|
10,000
|
3.40
|
|||||||||||
2,319,000
|
4.31
|
1.80
|
1,981,000
|
1.85
|
Shares
|
Weighted
Average
Exercise
Price
|
||||||
Non
vested at December 31, 2005
|
668,000 |
$
|
1.89
|
||||
Granted
|
432,000 | 1.25 | |||||
Vested
|
(763,000 | ) | 1.71 | ||||
Non
vested at December 31, 2006
|
337,000 |
$
|
1.48
|
(8) |
Research
Costs:
|
(9) |
Income
Taxes:
|
2006
|
2005
|
||||||
Current
|
|||||||
Federal
|
-
|
-
|
|||||
State
|
-
|
_
|
|||||
Total
Current Liability
|
-
|
-
|
|||||
Deferred
|
|||||||
Federal
|
($1,430,000
|
)
|
($1,010,000
|
)
|
|||
State
|
($488,000
|
)
|
($289,000
|
)
|
|||
Total
Deferred Liability
|
($1,918,000
|
)
|
($1,299,000
|
)
|
|||
Valuation
Allowance
|
$
|
1,918,000
|
$
|
1,299,000
|
|||
Total
|
-
|
-
|
(9) |
Income
Taxes, continued:
|
2006
|
|
2005
|
|||||
Deferred
Tax Assets (Liability)
|
|||||||
Current
|
|||||||
Interest
|
$
|
105,000
|
$
|
105,000
|
|||
Intangible
|
$
|
194,000
|
$
|
193,000
|
|||
NOL
|
$
|
4,439,000
|
$
|
2,706,000
|
|||
Deferred
state tax
|
($377,000
|
)
|
($211,000
|
)
|
|||
Stock
options
|
$
|
276,000
|
-
|
||||
Credits
|
$
|
150,000
|
-
|
||||
Other
|
$
|
76,000
|
$
|
103,000
|
|||
Non-Current
|
|||||||
Amortization
|
($92,000
|
)
|
($66,000
|
)
|
|||
Depreciation
|
($15,000
|
)
|
$
|
8,000
|
|||
Net
Deferred Tax Assets
|
$
|
4,756,000
|
$
|
2,838,000
|
|||
Less
Valuation Allowance
|
($4,756,000
|
)
|
($2,838,000
|
)
|
|||
Net
Deferred Tax Asset (Liability)
|
- |
-
|
(9) |
Income
Taxes, continued:
|
2006
|
|
2005
|
|||||
Federal
tax on pretax income at statutory rates
|
($1,459,000
|
)
|
($1,300,000
|
)
|
|||
State
tax, net of federal benefit
|
($327,000
|
)
|
($191,000
|
)
|
|||
Other
|
($131,000
|
)
|
$
|
192,000
|
|||
$
|
1,917,000
|
$
|
1,299,000
|
||||
Total
|
- | - |
(10) |
Related
Party Transactions:
|
(11) |
Employee
Benefit Plan:
|
(12) |
Subsequent
Events:
|
Name
|
Age
|
Position
|
||
Walter
C. Ogier
|
50
|
Director,
President and Chief Executive Officer
|
||
John
M. Vierling, M.D.
(2)
|
61
|
Director,
Chairman of the Board
|
||
Jack
E. Stover
(1)
|
54
|
Director
|
||
Thomas
C. Seoh (1)(3)
|
49
|
Director
|
||
Thomas
M. Tully (1)(2)(3)
|
61
|
Director
|
||
Dennis
Kogod (2)(3)
|
47
|
Director
|
||
Scott
L. Hayashi
|
35
|
Vice
President of Administration,
Chief Financial Officer
and Secretary
|
||
David
J. Zeffren
|
50
|
Vice
President of Product Development
|
||
Shawn
P. Cain
|
40
|
Vice
President of Operations
|
Name
and Principal Position
|
Year
|
|
Salary
|
|
Bonus
|
|
Option
Awards
|
|
Non-Equity
Incentive Plan Compensation
|
|
All
Other Compensation(6)
|
|
Total
|
|||||||||
Walter
C. Ogier,(1)
|
2006
|
$
|
300,000
|
-
|
-
|
-
|
$
|
7,980
|
$
|
307,980
|
||||||||||||
President
and Chief
|
2005
|
$
|
46,057
|
$
|
50,000
|
$
|
578,227
|
-
|
-
|
$
|
674,284
|
|||||||||||
Executive
Officer
|
||||||||||||||||||||||
Jacek
Rozga, M.D., Ph.D. (2)
|
2006
|
$
|
183,333
|
-
|
-
|
-
|
$
|
6,220
|
$
|
189,553
|
||||||||||||
Chief
Scientist
|
2005
|
$
|
199,177
|
-
|
$
|
15,150
|
$
|
24,000
|
$
|
2,750
|
$
|
241,077
|
||||||||||
2004
|
$
|
198,909
|
-
|
$
|
55,123
|
$
|
20,000
|
-
|
$
|
274,032
|
||||||||||||
2003
|
$
|
143,125
|
-
|
$
|
3,461
|
$
|
15,000
|
-
|
$
|
161,586
|
||||||||||||
Scott
L. Hayashi,
|
2006
|
$
|
109,167
|
-
|
$
|
25,103
|
-
|
$
|
3,759
|
$
|
138,029
|
|||||||||||
Vice
President of
|
2005
|
$
|
102,291
|
-
|
$
|
23,636
|
$
|
9,450
|
$
|
2,120
|
$
|
137,497
|
||||||||||
Administration,
Chief
|
2004(3
|
)
|
$
|
80,000
|
$
|
12,000
|
$
|
16,598
|
-
|
$
|
8,000
|
$
|
116,598
|
|||||||||
Financial
Officer and Secretary
|
||||||||||||||||||||||
David
J. Zeffren,
|
2006
|
$
|
117,000
|
-
|
-
|
-
|
$
|
3,479
|
$
|
120,479
|
||||||||||||
Vice
President of Product
|
2005
|
$
|
114,346
|
-
|
$
|
23,636
|
$
|
5,400
|
$
|
2,404
|
$
|
145,786
|
||||||||||
Development
|
2004(4
|
)
|
$
|
120,000
|
-
|
$
|
26,130
|
-
|
-
|
$
|
146,130
|
|||||||||||
Shawn
P. Cain,(5)
|
2006
|
$
|
160,000
|
-
|
$
|
43,930
|
-
|
$
|
5,505
|
$
|
209,435
|
|||||||||||
Vice
President of
|
2005
|
$
|
110,000
|
-
|
$
|
33,788
|
$
|
12,000
|
$
|
259
|
$
|
156,047
|
||||||||||
Operations
|
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
|
|||||||
Walter
C. Ogier
|
291,666
|
208,334
|
500,000
|
(1)
|
$
|
1.85
|
11/8/2010
|
|||||||||
Jacek
Rozga, M.D., Ph.D.
|
12,000
30,000
18,000
18,000
|
-
-
-
-
|
12,000
30,000
18,000
18,000
|
(2)
(3)
(4)
(5)
|
$
$
$
$
|
2.22
2.25
0.15
1.00
|
7/7/2012
2/9/2011
7/23/2012
4/20/2010
|
|||||||||
Scott
L. Hayashi
|
4,165
10,000
12,000
10,000
|
35,835
-
-
-
|
40,000
10,000
12,000
10,000
|
(6)
(7)
(8)
(9)
|
$
$
$
$
|
0.85
1.85
2.90
2.25
|
7/31/2013
3/24/2010
3/1/2010
2/9/2009
|
|||||||||
David
J. Zeffren
|
12,000
10,000
|
-
-
|
12,000
10,000
|
(8)
(10)
|
$
$
|
2.90
2.00
|
3/1/2010
2/9/2009
|
|||||||||
Shawn
P. Cain
|
7,290
28,750
|
62,710
1,250
|
70,000
30,000
|
(11)
(12)
|
$
$
|
0.85
1.65
|
7/31/2013
3/31/2010
|
(1)
|
The
option to purchase 500,000 shares of common stock was granted on
11/08/2005 and vests according to the following schedule: 50% of
the
option shall vest on the one year anniversary 11/08/2006, the remaining
50% shall vest on a monthly basis during the second year following
the
date of grant.
|
(2)
|
The
option to purchase 12,000 shares of common stock was fully vested
on
07/07/2006.
|
(3)
|
The
option to purchase 30,000 shares of common stock was fully vested
on
02/11/2005.
|
(4)
|
The
option to purchase 18,000 shares of common stock was fully vested
on
02/15/2003.
|
(5)
|
The
option to purchase 18,000 shares of common stock was fully vested
on
04/21/2004.
|
(6)
|
The
option to purchase 40,000 shares of common stock was granted on 07/31/2006
and vests on a monthly basis for a period of 48 months from the grant
date.
|
(7)
|
The
option to purchase 10,000 shares of common stock was fully vested
on
03/24/2006.
|
(8)
|
The
option to purchase 12,000 shares of common stock was fully vested
on
03/01/2006.
|
(9)
|
The
option to purchase 10,000 shares of common stock was fully vested
on
02/11/2005.
|
(10)
|
The
option to purchase 10,000 shares of common stock was fully vested
on
02/11/2005.
|
(11)
|
The
option to purchase 70,000 shares of common stock was granted on 07/31/2006
and vests on a pro-rata monthly basis for a period of 48 months from
the
date of grant.
|
(12)
|
The
option to purchase 30,000 shares of common stock was granted on 03/31/2005
and vests on a pro-rata monthly basis for a period of 24 months from
the
date of grant.
|
Name
|
Fees
Earned or Paid in Cash
|
|
Stock
Awards
|
|
Option
Awards
|
|
Total
|
||||||
John
M. Vierling(1)
|
$
|
17,500
|
$
|
16,819
|
$
|
33,704
|
$
|
68,023
|
|||||
Jack
E. Stover(2)
|
$
|
17,500
|
$
|
16,819
|
$
|
33,704
|
$
|
68,023
|
|||||
Thomas
C. Seoh(3)
|
$
|
10,000
|
$
|
9,399
|
$
|
34,664
|
$
|
54,063
|
|||||
Thomas
M. Tully(4)
|
$
|
9,500
|
$
|
9,399
|
$
|
40,858
|
$
|
59,758
|
|||||
Dennis
Kogod(5)
|
$
|
1,500
|
$
|
4,452
|
$
|
31,586
|
$
|
37,538
|
1.
|
John
M. Vierling, M.D. received 1) an option to purchase 44,957 shares
of
common stock with a fair value of $33,704, and 2) a restricted stock
grant
of 26,563 shares with a fair value of
$16,819.
|
2.
|
Jack
E. Stover received 1) an option to purchase 44,957 shares of common
stock
with a fair value of $33,704, and 2) a restricted stock grant of
26,563
shares with a fair value of
$16,819.
|
3.
|
Thomas
C. Seoh received 1) an option to purchase 37,856 shares of common
stock
with a fair value of $34,664, and 2) a restricted stock grant of
14,844
shares with a fair value of
$9,399.
|
4.
|
Thomas
M. Tully received 1) an option to purchase 28,613 shares of common
stock
with a fair value of $40,858 and 2) a restricted stock grant of 14,844
shares with a fair value of
$9,399.
|
5.
|
Dennis
Kogod received 1) an option to purchase 30,294 shares of common stock
with
a fair value of $31,586 and 2) a restricted stock grant of 7,031
shares
with a fair value of
$4,452.
|
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)
|
2,628,876
|
$
|
1.50
|
1,371,124
|
||||||
Equity
compensation plans not approved by security holders
|
637,000(2
|
)
|
$
|
2.41
|
-0-
|
|||||
Total
|
3,265,876
(3
|
)
|
$
|
1.69
|
1,371,124
|
Name
and Address of Beneficial Owner
|
Shares
Beneficially Owned (1)
|
Percentage
of Class
|
|||||
Jacek
Rozga, M.D., Ph.D.
|
2,228,000
|
(2)
|
12.7
|
%
|
|||
Achilles
A. Demetriou, M.D., Ph.D and Kristin P. Demetriou
|
2,500,000
|
(3)
|
14.3
|
%
|
|||
John
M. Vierling, M.D.
|
224,187
|
(4)
|
*
|
||||
Walter
C. Ogier
|
400,833
|
(5)
|
*
|
||||
Jack
E. Stover
|
139,187
|
(6)
|
*
|
||||
Thomas
C. Seoh
|
106,033
|
(7)
|
*
|
||||
Dennis
Kogod
|
100,658
|
(8)
|
*
|
||||
Thomas
Tully
|
128,457
|
(9)
|
*
|
||||
Scott
L. Hayashi
|
43,333
|
(10)
|
*
|
||||
David
Zeffren
|
72,000
|
(11)
|
*
|
||||
Shawn
Cain
|
44,583
|
(12)
|
*
|
||||
Gary
Ballen
|
1,139,222
|
(13)
|
6.3
|
%
|
|||
LibertyView
Funds, LP
111
River Street - Suite 1000
Hoboken,
NJ 07030-5776
|
1,578,892
|
(14)
|
8.8
|
%
|
|||
LibertyView
Special Opportunities Fund, LP
111
River Street - Suite 1000
Hoboken,
NJ 07030-5776
|
2,382,444
|
(15)
|
13.1
|
%
|
|||
Neuberger
Berman LLC
111
River Street - Suite 1000
Hoboken,
NJ 07030-5776
|
4,498,239
|
(16)
|
24.0
|
%
|
|||
All
executive officers and directors as a group (10 persons)
|
2,788,750
|
(17)
|
14.9
|
%
|
*
|
Less
than 1%.
|
(1)
|
Beneficial
ownership is determined in accordance with the rules of the Securities
and
Exchange Commission and generally includes voting or investment power
with
respect to securities. Shares of common stock subject to options,
warrants
and convertible securities currently exercisable or convertible,
or
exercisable or convertible within 60 days, are deemed outstanding,
including for purposes of computing the percentage ownership of the
person
holding such option, warrant or convertible security, but not for
purposes
of computing the percentage of any other
holder.
|
(2)
|
Includes
currently exercisable options to purchase 78,000 shares of common
stock.
|
(3)
|
Consists
of 2,500,000 shares owned by the A & K Demetriou Family Trust, of
which Achilles A. Demetriou, M.D., Ph.D. and Kristin P. Demetriou
each are
co-trustees with the right to vote or dispose of the trust’s
shares.
|
(4)
|
Consists
of i) currently exercisable options to purchase 197,624 shares of
common
stock, ii) 26,563 shares of restricted common
stock.
|
(5)
|
Consists
of i) currently exercisable options to purchase 395,833 shares of
common
stock and ii) 5,000 shares of common stock.
|
(6)
|
Consists
of i) currently exercisable options to purchase 111,624 shares of
common
stock ii) 26,563 shares of restricted common stock and iii)1,000
shares of
common stock.
|
(7)
|
Consists
of i) currently exercisable options to purchase 91,189 shares of
common
stock, ii) 14,844 shares of restricted common
stock.
|
(8)
|
Consists
of i) currently exercisable options to purchase 83,627 shares of
common
stock, ii) 7,031 shares of restricted common stock, and iii) 10,000
shares
of common stock.
|
(9)
|
Consists
of i) currently exercisable options to purchase 113,613 shares of
common
stock, ii) 14,844 shares of restricted common
stock.
|
(10)
|
Consists
of i) currently exercisable options to purchase 40,333 shares of
common
stock, ii) 3,000 shares of common
stock.
|
(11)
|
Consists
of i) 25,000 shares owned by Mira Zeffren, David Zeffren’s wife, (ii)
warrants to purchase 25,000 shares registered in the name of Mira
Zeffren,
and (iii) currently exercisable options held by David Zeffren for
the
purchase of 22,000 shares of common
stock.
|
(12)
|
Consists
of currently exercisable options to purchase 44,583 shares of common
stock.
|
(13)
|
Consists
of (i) 417,000 shares of common stock registered in Mr. Ballen’s name,
(ii) currently exercisable warrants to purchase 600,000 shares of
common
stock owned by Mr. Ballen, and (iii) 122,222 shares registered in
the name
of American Charter & Marketing LLC, over which Mr. Ballen has voting
and investment control.
|
(14)
|
Consists
of (i) 1,100,619 shares of common stock and (ii) currently exercisable
warrants to purchase 478,273 shares of common stock. LibertyView
Funds,
LP, LibertyView Special Opportunities Fund, LP and Trust D for a
Portion
of the Assets of the Kodak Retirement Income Plan have a common investment
advisor, Neuberger Berman, LLC, that has voting and dispositive power
over
the shares held by them, which is exercised by Richard A. Meckler.
Since
they have hired a common investment advisor, these entities are likely
to
vote together. Additionally, there may be common investors within
the
different accounts managed by the same investment advisor. The General
Partner of LibertyView Special Opportunities Fund, LP and LibertyView
Funds, LP is Neuberger Berman Asset Management, LLC, which is affiliated
with Neuberger Berman, LLC, a registered broker-dealer. LibertyView
Capital Management, a division of Neuberger Berman, LLC, is affiliated
with the General Partner of the LibertyView Health Sciences Fund,
LP. The
shares were purchased for investment in the ordinary course of business
and at the time of purchase, there were no agreements or understandings,
directly or indirectly, with any person to distribute the shares.
Trust D
for a Portion of the Assets of the Kodak Retirement Income Plan is
not in
any way affiliated with a broker-dealer.
|
(15)
|
Consists
of (i) 1,724,169 shares of common stock and (ii) currently exercisable
warrants to purchase 658,275 shares of common stock. LibertyView
Special
Opportunities Fund, LP, LibertyView Funds, LP and Trust D for a Portion
of
the Assets of the Kodak Retirement Income Plan have a common investment
advisor, Neuberger Berman, LLC, that has voting and dispositive power
over
the shares held by them, which is exercised by Richard A. Meckler.
Since
they have hired a common investment advisor, these entities are likely
to
vote together. Additionally, there may be common investors within
the
different accounts managed by the same investment advisor. The General
Partner of LibertyView Special Opportunities Fund, LP and LibertyView
Funds, LP is Neuberger Berman Asset Management, LLC, which is affiliated
with Neuberger Berman, LLC, a registered broker-dealer. LibertyView
Capital Management, a division of Neuberger Berman, LLC, is affiliated
with the General Partner of the LibertyView Health Sciences Fund,
LP. The
shares were purchased for investment in the ordinary course of business
and at the time of purchase, there were no agreements or understandings,
directly or indirectly, with any person to distribute the shares.
Trust D
for a Portion of the Assets of the Kodak Retirement Income Plan is
not in
any way affiliated with a
broker-dealer.
|
(16)
|
Includes
shares of common stock and currently exercisable warrants to purchase
shares of common stock held by Liberty Funds, LP and LibertyView
Special
Opportunities Fund, LP (see footnotes 14 and 15). Also includes (i)
386,689 shares of common stock held by Trust D for a Portion of the
Assets
of the Kodak Retirement Income Fund and (ii) currently exercisable
warrants to purchase 136,363 shares of common stock held by Trust
D for a
Portion of the Assets of the Kodak Retirement Income Plan. LibertyView
Funds, LP, LibertyView Special Opportunities Fund, LP and Trust D
for a
Portion of the Assets of the Kodak Retirement Income Plan have a
common
investment advisor, Neuberger Berman, LLC, that has voting and dispositive
power over the shares held by them, which is exercised by Richard
A.
Meckler. Since they have hired a common investment advisor, these
entities
are likely to vote together. Additionally, there may be common investors
within the different accounts managed by the same investment advisor.
The
General Partner of LibertyView Special Opportunities Fund, LP and
LibertyView Funds, LP is Neuberger Berman Asset Management, LLC,
which is
affiliated with Neuberger Berman, LLC, a registered broker-dealer.
LibertyView Capital Management, a division of Neuberger Berman, LLC,
is
affiliated with the General Partner of the LibertyView Health Sciences
Fund, LP. The shares were purchased for investment in the ordinary
course
of business and at the time of purchase, there were no agreements
or
understandings, directly or indirectly, with any person to distribute
the
shares. Trust D for a Portion of the Assets of the Kodak Retirement
Income
Plan is not in any way affiliated with a broker-dealer.
|
(17)
|
Includes
currently exercisable options and warrants to purchase 1,203,427
shares of
common stock.
|
Exhibit
Number
|
Description
|
|
2.1
|
Agreement
and Plan of Reorganization, dated October 20, 2003, between the
Registrant, Arbios Technologies, Inc., HAUSA Acquisition, Inc., Cindy
Swank and Raymond Kuh (1)
|
|
3.1
|
Certificate
of Incorporation filed with the Secretary of State of the State of
Delaware on June 3, 2005 (10)
|
|
3.2
|
Certificate
of Correction filed with the Secretary of State of the State of Delaware
on July 6, 2005 (10)
|
|
3.3
|
Certificate
of Ownership and Merger filed with the Secretary of State of the
State of
Delaware on July 25, 2005 (10)
|
|
3.4
|
Certificate
of Ownership and Merger filed with the Secretary of State of the
State of
Delaware on July 26, 2005 (10)
|
|
3.5
|
Bylaws
(10)
|
|
4.1
|
Form
of Common Stock certificate (10)
|
|
4.2
|
Form
of Warrant for the Purchase of Shares of Common Stock issued by the
Registrant upon the assumption of the Arbios Technologies, Inc.
outstanding Warrant (3)
|
|
4.3
|
Common
Stock Purchase Warrant, dated April 1, 2004, issued to Wolfe Axelrod
Weinberger Associates LLC (4)
|
|
4.4
|
Form
of Warrant to Purchase Common Stock of Arbios Systems, Inc., dated
January
11, 2005, issued to investors and placement agent (5)
|
|
10.1
|
Form
of 2001 Stock Option Plan (2)*
|
|
10.2
|
Facilities
Lease, entered into as of June 30, 2001, by and between Cedars-Sinai
Medical Center and Arbios Technologies, Inc. (3)
|
|
10.3
|
Standard
Multi-Tenant Office Lease, dated as of August 16, 2005, by and between
Beverly Robertson Design Plaza and Arbios Systems, Inc.
(10)
|
10.4
|
Employee
Loan-Out Agreement, entered into effective as of July 1, 2001, by
and
between Cedars-Sinai Medical Center and Arbios Technologies, Inc.
(3)
|
|
10.5
|
Second
Amendment to Employee Loan-Out Agreement, entered into effective
as of May
7, 2003, by and between Cedars-Sinai Medical Center and Arbios
Technologies, Inc. (3)
|
|
10.6
|
License
Agreement, entered into as of June 2001, by and between Cedars-Sinai
Medical Center and Arbios Technologies, Inc. (3)
|
|
10.7
|
Spectrum
Labs License Agreement (3)
|
|
10.8
|
Third
Amendment to Employee Loan-Out Agreement, entered into effective
as of
June 21, 2004, by and between Cedars-Sinai Medical Center and Arbios
Systems, Inc. (4)
|
|
10.9
|
Asset
Purchase Agreement among Circe Biomedical, Inc., a Delaware corporation,
Arbios Technologies, Inc., and Arbios Systems, Inc., dated as of
April 7,
2004(4)
|
|
10.10
|
Manufacturing
and Supply Agreement, dated as of December 26, 2001, between Spectrum
Laboratories, Inc. and Arbios Technologies, Inc. (4)
|
|
10.11
|
Research
Agreement, dated as of December 26, 2001, between Spectrum Laboratories,
Inc. and Arbios Technologies, Inc. (4)
|
|
10.12
|
First
Amendment to Research Agreement, dated as of October 14, 2002, between
Spectrum Laboratories, Inc. and Arbios Technologies, Inc.
(4)
|
|
10.13
|
Third
Amendment to Facilities Lease, entered into effective as of June
21, 2004,
by and between Cedars-Sinai Medical Center and Arbios Technologies,
Inc.
(4)
|
|
10.14
|
Form
of Purchase Agreement, dated as of January 11, 2005, by and among
Arbios
Systems, Inc. and the Investors named therein. (5)
|
|
10.15
|
Form
of Registration Rights Agreement, dated as of January 11, 2005, by
and
among Arbios Systems, Inc. and the Investors named
therein.(5)
|
|
10.16
|
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.
|
|
10.17
|
Employment
Offer Letter, dated December 30, 2004, between Arbios Systems, Inc.
and
David Zeffren.* (10)
|
|
10.18
|
Employment
Offer Letter, dated March 25, 2005, between Arbios Systems, Inc.
and Shawn
Cain.* (10)
|
|
10.19
|
Employment
Offer Letter, dated March 29, 2005, between Arbios Systems, Inc.
and Scott
Hayashi.* (10)
|
10.20
|
Employment
Agreement, entered into between Arbios Systems, Inc. and Amy Factor,
effective as of March 31, 2005 (6)*
|
|
10.21
|
Employment
Offer Letter, dated July 28, 2005, between Arbios Systems, Inc. and
Jacek
Rozga, M.D., Ph.D. (7)*
|
|
10.22
|
2005
Stock Incentive Plan (8)*
|
|
10.23
|
Form
of Stock Option Agreement for the 2005 Stock Incentive Plan
(8)*
|
|
10.24
|
Employment
Offer Letter, dated October 17, 2005, between Arbios Systems, Inc.
and
Walter C. Ogier. (9)*
|
|
10.25
|
Consulting
Agreement, dated October 1, 2005, between Arbios Systems, Inc. and
Marvin
S. Hausman, M.D. (9)
|
|
10.26
|
Form
of Lease, dated April 1, 2005, between Arbios Technologies, Inc.
and
American Integrated Biologics, Inc. (7)
|
|
10.27
|
License
Agreement, dated March 29, 2007, between Arbios Systems, Inc. and
Immunocept, LLC (11)
|
|
10.28
|
Form
of Warrant Agreement, Immunocept, LLC license (11)
|
|
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
|
ARBIOS
SYSTEMS, INC.
|
||
|
|
|
Date: April 16, 2007 | By: |
/s/
WALTER C. OGIER
|
Walter
C. Ogier, President and Chief Executive
Officer
|
Signature
|
Title
|
Date
|
||
/s/
WALTER C. OGIER
Walter
C. Ogier
|
President
and Chief Executive Officer (principal executive officer)
|
April
16, 2007
|
||
/s/
SCOTT L. HAYASHI
Scott
L. Hayashi
|
Chief
Financial Officer (principal financial officer and principal accounting
officer)
|
April
16, 2007
|
||
/s/
JOHN M.VIERLING, MD
John
M. Vierling, MD
|
Chairman
of the Board, and Director
|
April
16, 2007
|
||
/s/
JACK E. STOVER
Jack
E. Stover
|
Director
|
April
16, 2007
|
||
/s/
THOMAS C. SEOH
Thomas
C. Seoh
|
Director
|
April
16, 2007
|
||
/s/
THOMAS M. TULLY
Thomas
M. Tully
|
Director
|
April
16, 2007
|
||
/s/
DENNIS KOGOD
Dennis
Kogod
|
Director
|
April
16, 2007
|
Exhibit
Number
|
Description
|
|
2.1
|
Agreement
and Plan of Reorganization, dated October 20, 2003, between the
Registrant, Arbios Technologies, Inc., HAUSA Acquisition, Inc., Cindy
Swank and Raymond Kuh (1)
|
|
3.1
|
Certificate
of Incorporation filed with the Secretary of State of the State of
Delaware on June 3, 2005 (10)
|
|
3.2
|
Certificate
of Correction filed with the Secretary of State of the State of Delaware
on July 6, 2005 (10)
|
|
3.3
|
Certificate
of Ownership and Merger filed with the Secretary of State of the
State of
Delaware on July 25, 2005 (10)
|
|
3.4
|
Certificate
of Ownership and Merger filed with the Secretary of State of the
State of
Delaware on July 26, 2005 (10)
|
|
3.5
|
Bylaws
(10)
|
|
4.1
|
Form
of Common Stock certificate (10)
|
|
4.2
|
Form
of Warrant for the Purchase of Shares of Common Stock issued by the
Registrant upon the assumption of the Arbios Technologies, Inc.
outstanding Warrant (3)
|
|
4.3
|
Common
Stock Purchase Warrant, dated April 1, 2004, issued to Wolfe Axelrod
Weinberger Associates LLC (4)
|
|
4.4
|
Form
of Warrant to Purchase Common Stock of Arbios Systems, Inc., dated
January
11, 2005, issued to investors and placement agent (5)
|
|
10.1
|
Form
of 2001 Stock Option Plan (2)*
|
|
10.2
|
Facilities
Lease, entered into as of June 30, 2001, by and between Cedars-Sinai
Medical Center and Arbios Technologies, Inc. (3)
|
|
10.3
|
Standard
Multi-Tenant Office Lease, dated as of August 16, 2005, by and between
Beverly Robertson Design Plaza and Arbios Systems, Inc.
(10)
|
|
10.4
|
Employee
Loan-Out Agreement, entered into effective as of July 1, 2001, by
and
between Cedars-Sinai Medical Center and Arbios Technologies, Inc.
(3)
|
|
10.5
|
Second
Amendment to Employee Loan-Out Agreement, entered into effective
as of May
7, 2003, by and between Cedars-Sinai Medical Center and Arbios
Technologies, Inc. (3)
|
|
10.6
|
License
Agreement, entered into as of June 2001, by and between Cedars-Sinai
Medical Center and Arbios Technologies, Inc.
(3)
|
10.7
|
Spectrum
Labs License Agreement (3)
|
|
10.8
|
Third
Amendment to Employee Loan-Out Agreement, entered into effective
as of
June 21, 2004, by and between Cedars-Sinai Medical Center and Arbios
Systems, Inc. (4)
|
|
10.9
|
Asset
Purchase Agreement among Circe Biomedical, Inc., a Delaware corporation,
Arbios Technologies, Inc., and Arbios Systems, Inc., dated as of
April 7,
2004(4)
|
|
10.10
|
Manufacturing
and Supply Agreement, dated as of December 26, 2001, between Spectrum
Laboratories, Inc. and Arbios Technologies, Inc. (4)
|
|
10.11
|
Research
Agreement, dated as of December 26, 2001, between Spectrum Laboratories,
Inc. and Arbios Technologies, Inc. (4)
|
|
10.12
|
First
Amendment to Research Agreement, dated as of October 14, 2002, between
Spectrum Laboratories, Inc. and Arbios Technologies, Inc.
(4)
|
|
10.13
|
Third
Amendment to Facilities Lease, entered into effective as of June
21, 2004,
by and between Cedars-Sinai Medical Center and Arbios Technologies,
Inc.
(4)
|
|
10.14
|
Form
of Purchase Agreement, dated as of January 11, 2005, by and among
Arbios
Systems, Inc. and the Investors named therein. (5)
|
|
10.15
|
Form
of Registration Rights Agreement, dated as of January 11, 2005, by
and
among Arbios Systems, Inc. and the Investors named
therein.(5)
|
|
10.16
|
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.
|
|
10.17
|
Employment
Offer Letter, dated December 30, 2004, between Arbios Systems, Inc.
and
David Zeffren.* (10)
|
|
10.18
|
Employment
Offer Letter, dated March 25, 2005, between Arbios Systems, Inc.
and Shawn
Cain.* (10)
|
|
10.19
|
Employment
Offer Letter, dated March 29, 2005, between Arbios Systems, Inc.
and Scott
Hayashi.* (10)
|
|
10.20
|
Employment
Agreement, entered into between Arbios Systems, Inc. and Amy Factor,
effective as of March 31, 2005 (6)*
|
|
10.21
|
Employment
Offer Letter, dated July 28, 2005, between Arbios Systems, Inc. and
Jacek
Rozga, M.D., Ph.D. (7)*
|
|
10.22
|
2005
Stock Incentive Plan (8)*
|
|
10.23
|
Form
of Stock Option Agreement for the 2005 Stock Incentive Plan
(8)*
|
|
10.24
|
Employment
Offer Letter, dated October 17, 2005, between Arbios Systems, Inc.
and
Walter C. Ogier. (9)*
|
10.25
|
Consulting
Agreement, dated October 1, 2005, between Arbios Systems, Inc. and
Marvin
S. Hausman, M.D. (9)
|
|
10.26
|
Form
of Lease, dated April 1, 2005, between Arbios Technologies, Inc.
and
American Integrated Biologics, Inc. (7)
|
|
10.27
|
License
Agreement, dated March 29, 2007, between Arbios Systems, Inc. and
Immunocept, LLC (11)
|
|
10.28
|
Form
of Warrant Agreement, Immunocept, LLC license (11)
|
|
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
|