(Mark
One)
|
||
x
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
|
For
the fiscal year ended December 31, 2008
|
||
or
|
||
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For
the transition period
from to
|
Delaware
|
75-2242792
|
(State
or other jurisdiction of
Incorporation
or organization)
|
(I.R.S.
Employer
Identification
Number)
|
Title of Each Class
|
Name of Each Exchange on Which
Registered
|
|
Common
Stock, $0.0001 par value
|
NYSE
Amex
|
Large
accelerated filer £
|
Accelerated
filer £
|
Non-accelerated
filer £
(Do
not check if a smaller reporting company)
|
Smaller
reporting company x
|
Forward
Looking Statements
|
3
|
|
PART
I
|
||
Item
1.
|
Business
|
4
|
Item
1A.
|
Risk
Factors
|
11
|
Item
1B.
|
Unresolved
Staff Comments
|
20
|
Item
2.
|
Properties
|
20
|
Item
3.
|
Legal
Proceedings
|
20
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
22
|
PART
II
|
||
Item
5.
|
Market
For Registrant’s Common Equity, Related Stockholder Maters and Issuer
Purchases of Equity
|
23
|
Item
6.
|
Selected
Financial Data
|
23
|
Item
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
23
|
Item
7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
28
|
Item
8.
|
Financial
Statements and Supplementary Data
|
29
|
Item
9.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
50
|
Item
9A.
|
Controls
and Procedures
|
50
|
Item
9B.
|
Other
Information
|
51
|
PART
III
|
||
Item
10.
|
Directors,
Executive Officers and Corporate Governance
|
52
|
Item
11.
|
Executive
Compensation
|
54
|
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
62
|
Item
13.
|
Certain
Relationships and Related Transactions and Director
Independence
|
63
|
Item
14:
|
Principal
Accounting Fees and Services
|
64
|
PART
IV
|
||
Item
15:
|
Exhibits
and Financial Statement Schedules
|
65
|
Signatures
|
66
|
·
|
the
effect of receiving a “going concern” statement in our independent
registered public accounting firm’s report on our 2008 financial
statements;
|
·
|
our
significant capital needs and ability to obtain financing both on a
short-term and a long-term basis;
|
·
|
the
results of the arbitration proceeding with National Quality Care, Inc., or
“NQCI”;
|
·
|
our
ability to meet continued listing standards of NYSE Amex (formerly
American Stock Exchange);
|
·
|
our
ability to successfully research and develop marketable
products;
|
·
|
our
ability to obtain regulatory approval to market and distribute our
products;
|
·
|
anticipated
trends and conditions in the industry in which we operate, including
regulatory changes;
|
·
|
general
economic conditions; and
|
·
|
other
risks and uncertainties as may be detailed from time to time in our public
announcements and filings with the U.S. Securities and Exchange
Commission, or the “SEC”.
|
·
|
A
Portable Artificial Kidney, or “PAK”, for attended care Renal Replacement
Therapy, or “RRT”, for patients suffering from Acute Renal Failure, or
“ARF”
|
·
|
A
PAK for home hemodialysis for patients suffering from End Stage Renal
Disease, or “ESRD”
|
·
|
A
Wearable Artificial Kidney, or “WAK”, for continuous ambulatory
hemodialysis for treatment of ESRD
|
·
|
Reductions
in our labor force – On March 13, 2009, we gave notice of employment
termination to 19 employees. This represents a total work-force reduction
of approximately 73%. We paid accrued vacation benefits of approximately
$70,000 to the terminated employees. The layoffs and our other efforts
focused on streamlining our operations designed to reduce our annual
expenses by approximately $3.5 million to a current operating burn rate of
approximately $200,000 per month. These actions had to be carefully and
thoughtfully executed and we will take additional actions, if necessary.
Most important to us in making these difficult decisions is to give as
much consideration as possible to all of our employees, whom we greatly
value. We hope to be in the financial position in the near future to offer
re-employment to certain of our terminated
employees.
|
·
|
Refocusing
our available assets and employee resources on the development of the
PAK.
|
·
|
Continuing
vigorous efforts to minimize or defer our operating
expenses.
|
·
|
Exploring
various strategic alternatives, which may include the license of certain
of our intellectual property rights, as a means to further develop our
technologies, among other possible transactions and
alternatives.
|
·
|
Intensifying
our search to obtain additional financing to support our operations and to
satisfy our ongoing capital requirements in order to improve our liquidity
position.
|
·
|
Continuing
to prosecute our patents and take other steps to perfect our intellectual
property rights.
|
·
|
Subject
to the satisfaction of the terms of the Interim Award, as modified by the
Order, NQCI will grant, transfer and assign to Operations all of the
Technology covered by the License Agreement currently in effect between
NQCI and Operations;
|
·
|
The
Technology includes all patents and patent applications related to a WAK
and other portable or continuous dialysis methods or
devices;
|
·
|
Under
the terms of the Interim Award, as modified by the Order, we filed a proxy
statement with the SEC to obtain stockholder approval for the issuance of
shares of our common stock to acquire the Technology and issue to NQCI
9,230,000 shares of our common
stock;
|
·
|
If
and when we are able to do so, we will issue and deliver to
NQCI 9,230,000 shares of our common stock in consideration for the
Technology. As a result, NQCI will own approximately 39% of our
outstanding common stock and become our largest
stockholder;
|
·
|
Except
for its definition, indemnification, representation and warranty
provisions, the License Agreement shall thereafter be terminated and be of
no further force or effect; and
|
·
|
After
the transfer of the Technology by NQCI to us, under the Interim Award, as
modified by the Order, we will be required to file a registration
statement with the SEC to register for resale under the Securities Act the
shares issued to NQCI, referred to herein as the “Registration
Statement”.
|
(a)
|
any
medical device, treatment or method as of September 1,
2006;
|
|
(b)
|
any
portable or continuous dialysis methods or devices, specifically including
any wearable artificial kidney, or “Wearable Kidney”, and related
devices;
|
|
(c)
|
any
device, methods or treatments for congestive heart failure;
and
|
|
(d)
|
any
artificial heart or coronary
device.
|
(a)
|
patents,
patent applications, and patent rights;
|
|
(b)
|
trademarks,
trademark registrations and applications;
|
|
(c)
|
copyrights,
copyright registrations, and applications; and
|
|
(d)
|
trade
secrets, confidential information and
know-how.
|
·
|
that a broker or dealer approve a person's account for
transactions in penny stocks; and
|
·
|
the broker or dealer receive from
the investor a written
agreement to
the transaction, setting forth the
identity and quantity of the penny stock to be
purchased.
|
·
|
obtain financial information and investment experience
objectives of the person; and
|
·
|
make
a reasonable determination that the transactions in
penny
stocks are suitable for that person and the person has
sufficient knowledge and experience in
financial matters to be capable of evaluating the risks of
transactions in penny stocks.
|
·
|
sets forth the
basis on which the broker or dealer made
the suitability determination;
and
|
·
|
that
the broker or dealer received a
signed, written agreement from the investor prior to
the transaction.
|
·
|
the
number of shares available for sale in the
market;
|
·
|
sales
of our common stock by shareholders because our business profile does not
fit their investment objectives;
|
·
|
actual
or anticipated fluctuations in our operating
results;
|
·
|
developments
relating to our products and related proprietary
rights;
|
·
|
actual
or anticipated announcements of new data and announcements relating to our
operating performance;
|
·
|
government
regulations and changes thereto and regulatory investigations or
determinations;
|
·
|
our
ability to meet continued listing standards of NYSE
Amex
|
·
|
announcements
of our competitors or their success in the biotechnology and healthcare
equipment business, including those in the dialysis
industry;
|
·
|
recruitment
or departures of key personnel;
|
·
|
the
gain or loss of significant
customers;
|
·
|
the
operating and stock price performance of other comparable
companies;
|
·
|
developments
and publicity regarding our industry;
and
|
·
|
general
economic and market conditions in our industry and the economy as a
whole.
|
·
|
In
accordance with the second paragraph of page 7 of the Award, under the
Merger Agreement, the number of shares of our common stock which NQCI was
to receive at the closing of the transaction contemplated by the Merger
Agreement was based on the number of shares or our common stock
outstanding as of the date of the Merger Agreement, or 10,000,000
shares.
|
·
|
If
the Merger Agreement was terminated, resulting in the closing of the
Technology Transaction, (i) pursuant to Section 6(B)(2)(i) of the Merger
Agreement, NQCI was to receive a 48% share of the aggregate amount of our
shares of common stock if we terminated the Merger Agreement for NQCI’s
breach or either party terminated under the December 1 or December 29
deadlines, and (ii) pursuant to Section 6(B)(2)(ii) of the Merger
Agreement, NQCI was to get a 54% share if we terminated for
dissatisfaction with our due diligence, or NQCI terminated for our breach
(as more fully described in the Merger
Agreement).
|
·
|
The
arbitrator determined that NQCI was not entitled to terminate the Merger
Agreement outright and that its notice of termination was improper.
Therefore, the arbitrator determined that, since NQCI was at fault, NQCI
is entitled to receive the lesser of the two alternatives (48% instead of
54%).
|
·
|
Therefore,
according to the arbitrator, in order to award a 48% share to NQCI,
assuming that there were 10,000,000 shares of our common stock outstanding
on the date of the Merger Agreement, we must issue to NQCI 9,230,000
shares of our common stock, which would represent 48% of the aggregate
total of 19,230,000 shares of our common stock which would have been
outstanding after giving effect to such
issuance.
|
High | Low | |||||||
Fiscal
Year Ended December 31, 2008
|
||||||||
4th
Quarter
|
$ | 0.50 | $ | 0.16 | ||||
3rd
Quarter
|
1.44 | 0.50 | ||||||
2nd
Quarter
|
4.21 | 1.00 | ||||||
1ST
Quarter
|
4.94 | 2.34 |
High | Low | |||||||
Fiscal
Year Ended December 31, 2007
|
||||||||
4th
Quarter
|
$ | 14.06 | $ | 4.27 | ||||
3rd
Quarter
|
17.45 | 3.39 | ||||||
2nd
Quarter
|
6.62 | 4.30 | ||||||
1ST
Quarter
|
13.89 | 2.40 |
Number
of Securities
|
||||||||||||
Remaining
Available
|
||||||||||||
Number
of Securities
|
for
Future Issuances
|
|||||||||||
to
be Issued
|
Weighted-Average
|
Under
the Equity
|
||||||||||
Upon
Exercise of
|
Exercise
Price of
|
Compensation
Plans
|
||||||||||
Outstanding
Options,
|
Outstanding
Options,
|
(Excluding
Securities
|
||||||||||
Plan
Category
|
Warrants and
Rights
|
Warrants and
Rights
|
Reflected in
Column(a))
|
|||||||||
(a)
|
(b)
|
(c)
|
||||||||||
Equity
compensation plans approved by security holders
|
3,877,500
|
$
|
5.39
|
2,922,500
|
||||||||
Equity
compensation plans not approved by security holders
|
—
|
$
|
—
|
—
|
||||||||
Total
|
3,877,500
|
$
|
5.39
|
2,922,500
|
·
|
Reductions
in our labor force – On March 13, 2009, we gave notice of employment
termination to 19 employees. This represents a total work-force reduction
of approximately 73%. We paid accrued vacation benefits of approximately
$70,000 to the terminated employees. The layoffs and our other efforts
focused on streamlining our operations designed to reduce our annual
expenses by approximately $3.5 million to a current operating burn rate of
approximately $200,000 per month. These actions had to be carefully and
thoughtfully executed and we will take additional actions, if necessary.
Most important to us in making these difficult decisions is to give as
much consideration as possible to all of our employees, whom we greatly
value. We hope to be in the financial position in the near future to offer
re-employment to certain of our terminated
employees.
|
·
|
Refocusing
our available assets and employee resources on the development of the
PAK.
|
·
|
Continuing
vigorous efforts to minimize or defer our operating
expenses.
|
·
|
Exploring
various strategic alternatives, which may include the license of certain
of our intellectual property rights, as a means to further develop our
technologies, among other possible transactions and
alternatives.
|
·
|
Intensifying
our search to obtain additional financing to support our operations and to
satisfy our ongoing capital requirements in order to improve our liquidity
position.
|
·
|
Continuing
to prosecute our patents and take other steps to perfect our intellectual
property rights.
|
Contractual
Obligations:
|
Total
|
Less than 1
year
|
1 - 3 years
|
3 - 5 years
|
More
than 5 years
|
|||||||||||||||
Capital Lease
Obligations
|
$ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||
Operating Lease Obligations
(1)
|
2,422,931 | 411,845 | 1,677,342 | 333,744 | - | |||||||||||||||
Research & Development
Contractual Commitments
|
68,688 | 68,688 | - | - | - | |||||||||||||||
Other
Liabilities
|
34,325 | 34,325 | - | - | - | |||||||||||||||
$ | 2,525,944 | $ | 514,858 | $ | 1,677,342 | $ | 333,744 | $ | - |
December 31, 2008 | ||||||||||||
Aggregate
Fair
|
Gross
Unrealized
|
Estimated
Fair
|
||||||||||
Value
|
Gains /
(Losses)
|
Value
|
||||||||||
Commercial
paper
|
$ | 897,993 | $ | - | $ | 897,993 | ||||||
Corporate
securities fixed rate
|
457,930 | - | 457,930 | |||||||||
Total
|
$ | 1,355,923 | $ | - | $ | 1,355,923 |
December 31, 2007 | ||||||||||||
Aggregate
Fair
|
Gross
Unrealized
|
Estimated
Fair
|
||||||||||
Value
|
Gains /
(Losses)
|
Value
|
||||||||||
Commercial
paper
|
$ | 10,283,818 | $ | - | $ | 10,283,818 | ||||||
Corporate
obligation
|
2,245,770 | - | 2,245,770 | |||||||||
Total
|
$ | 12,529,588 | $ | - | $ | 12,529,588 |
PAGE
|
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
30
|
FINANCIAL
STATEMENTS
|
|
BALANCE
SHEETS AS OF DECEMBER 31, 2008 AND 2007
|
31
|
STATEMENTS
OF OPERATIONS FOR THE YEARS ENDED DECEMBER 31, 2008 AND 2007, AND THE
PERIOD FROM INCEPTION (MAY 4, 2001) TO DECEMBER 31, 2008
|
32
|
STATEMENTS
OF STOCKHOLDERS’ EQUITY (DEFICIT) FOR THE YEARS ENDED DECEMBER 31, 2008
AND 2007, AND THE PERIOD FROM INCEPTION (MAY 4, 2001) TO DECEMBER 31,
2008
|
33
|
STATEMENTS
OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2008 AND 2007, AND THE
PERIOD FROM INCEPTION (MAY 4, 2001) TO DECEMBER 31, 2008
|
34
|
NOTES
TO FINANCIAL STATEMENTS
|
35
|
Years
ended
|
||||||||
December
31,
|
||||||||
2008
|
2007
|
|||||||
ASSETS
|
||||||||
Current
|
||||||||
Cash
and cash equivalents
|
$ | 407,585 | $ | 106,495 | ||||
Marketable
securities, at fair value
|
2,955,714 | 16,401,898 | ||||||
Restricted
cash
|
301,675 | 68,016 | ||||||
Prepaid
expenses & other current assets
|
260,024 | 408,303 | ||||||
Tenant
improvement allowance receivable
|
87,658 | - | ||||||
Total
current assets
|
4,012,656 | 16,984,712 | ||||||
Property
and equipment, net
|
337,554 | 266,912 | ||||||
Other
assets
|
863 | 922 | ||||||
Total
Assets
|
$ | 4,351,073 | $ | 17,252,546 | ||||
LIABILITIES
|
||||||||
Current
|
||||||||
Accounts
payable
|
$ | 789,827 | $ | 1,125,239 | ||||
Accrued
legal fees & licensing expense
|
2,873,396 | 312,208 | ||||||
Accrued
royalties
|
583,333 | 83,333 | ||||||
Accrued
professional fees
|
211,820 | 113,020 | ||||||
Accrued
compensation
|
149,664 | 196,541 | ||||||
Accrued
other liabilities
|
54,429 | 68,946 | ||||||
Payroll
liabilities
|
7,448 | 11,926 | ||||||
Deferred
rent
|
148,651 | - | ||||||
Other
current liabilities
|
- | 115,400 | ||||||
Total
current liabilities
|
4,818,568 | 2,026,613 | ||||||
Shares
issuable
|
1,569,100 | - | ||||||
COMMITMENTS
& CONTINGENCIES
|
||||||||
STOCKHOLDERS'
EQUITY
|
||||||||
Preferred
stock, $0.0001 par value, 10,000,000 shares authorized, none
outstanding
|
- | - | ||||||
Common
stock, $0.0001 par value, 40,000,000 shares authorized, 14,754,687 and
14,372,472 issued and outstanding on December 31, 2008 and December 31,
2007, respectively
|
1,475 | 1,437 | ||||||
Additional
paid-in capital
|
42,547,023 | 36,822,316 | ||||||
Deficit
accumulated during the development stage
|
(44,585,093 | ) | (21,597,820 | ) | ||||
Total
stockholders' (deficit) equity
|
(2,036,595 | ) | 15,225,933 | |||||
Total
Liabilities & Stockholders' (Deficit) Equity
|
$ | 4,351,073 | $ | 17,252,546 |
May
4, 2001 (Date
|
||||||||||||
Years
ended
|
of
Inception) to
|
|||||||||||
December
31,
|
December
31,
|
|||||||||||
2008
|
2007
|
2008
|
||||||||||
Operating
Expenses:
|
||||||||||||
Selling,
general and administrative
|
$ | 9,001,819 | $ | 11,084,040 | $ | 23,404,511 | ||||||
Research and
development
|
20,914,825 | 7,141,170 | 29,343,317 | |||||||||
Other
expenses
|
1,871,430 | - | 1,871,430 | |||||||||
Depreciation and
amortization
|
104,719 | 32,171 | 136,985 | |||||||||
Loss
before other income, income taxes, and other
|
||||||||||||
expenses
|
(31,892,793 | ) | (18,257,381 | ) | (54,756,243 | ) | ||||||
Interest
and other income
|
323,249 | 1,184,930 | 1,590,479 | |||||||||
Change
in fair value of shares issuable
|
8,583,900 | - | 8,583,900 | |||||||||
Loss
before income taxes and other expenses
|
(22,985,644 | ) | (17,072,451 | ) | (44,581,864 | ) | ||||||
Income
taxes
|
1,629 | 1,600 | 3,229 | |||||||||
Net
loss
|
$ | (22,987,273 | ) | $ | (17,074,051 | ) | $ | (44,585,093 | ) | |||
Basic
and diluted loss per share
|
$ | (1.57 | ) | $ | (1.20 | ) | ||||||
Weighted
average number of shares outstanding
|
14,604,274 | 14,206,489 |
Deficit
|
|||||||||||||||||||||
Accumulated
|
|||||||||||||||||||||
Additional
|
During
|
||||||||||||||||||||
Common
Stock
|
Paid-in
|
Development
|
|||||||||||||||||||
Shares
|
Amount
|
Capital
|
Stage
|
Total
|
|||||||||||||||||
Common
stock issued for cash at $0.01 per share
|
2,500,000 | $ | 250 | $ | 24,750 | $ | 25,000 | ||||||||||||||
Net
Loss for the year ended December 31, 2001
|
$ | (40,255 | ) | (40,255 | ) | ||||||||||||||||
Balance
as of December 31, 2001
|
2,500,000 | 250 | 24,750 | (40,255 | ) | (15,255 | ) | ||||||||||||||
Common
stock issued for cash at $0.05 per share
|
1,320,000 | 132 | 65,868 | 66,000 | |||||||||||||||||
Net
Loss for the year ended December 31, 2002
|
(31,249 | ) | (31,249 | ) | |||||||||||||||||
Balance
as of December 31, 2002
|
3,820,000 | 382 | 90,618 | (71,504 | ) | 19,496 | |||||||||||||||
Net
Loss for the year ended December 31, 2003
|
(12,962 | ) | (12,962 | ) | |||||||||||||||||
Balance
as of December 31, 2003
|
3,820,000 | 382 | 90,618 | (84,466 | ) | 6,534 | |||||||||||||||
Net
Loss for the year ended December 31, 2004
|
(23,338 | ) | (23,338 | ) | |||||||||||||||||
Balance
as of December 31, 2004
|
3,820,000 | 382 | 90,618 | (107,804 | ) | (16,804 | ) | ||||||||||||||
Net
Loss for the year ended December 31, 2005
|
(35,753 | ) | (35,753 | ) | |||||||||||||||||
Balance
as of December 31, 2005
|
3,820,000 | 382 | 90,618 | (143,557 | ) | (52,557 | ) | ||||||||||||||
Common
stock issued for license rights at $0.0001 per
|
|||||||||||||||||||||
share
|
9,600,000 | 960 | 40 | 1,000 | |||||||||||||||||
Capital
stock cancelled
|
(3,420,000 | ) | (342 | ) | 342 | - | |||||||||||||||
Warrants
granted for consulting fees
|
2,162,611 | 2,162,611 | |||||||||||||||||||
Forgiveness
of related party debt
|
64,620 | 64,620 | |||||||||||||||||||
Common
stock issued for cash at $7.00, net of placement
|
|||||||||||||||||||||
fees
of $2,058,024
|
4,200,050 | 420 | 27,341,928 | 27,342,348 | |||||||||||||||||
Stock-based
compensation expense
|
264,251 | 264,251 | |||||||||||||||||||
Net
loss for the period
|
(4,380,212 | ) | (4,380,212 | ) | |||||||||||||||||
Balance
as of December 31, 2006
|
14,200,050 | 1,420 | 29,924,410 | (4,523,769 | ) | 25,402,061 | |||||||||||||||
Capital
stock cancelled
|
(200,000 | ) | (20 | ) | 20 | - | |||||||||||||||
Common
stock issued pursuant to consulting agreement at
|
|||||||||||||||||||||
$ |
4.90
per share
|
20,000 | 2 | 97,998 | 98,000 | ||||||||||||||||
Recapitalization
pursuant to merger
|
352,422 | 35 | (37,406 | ) | (37,371 | ) | |||||||||||||||
Warrants
granted for consulting services
|
2,917,309 | 2,917,309 | |||||||||||||||||||
Stock-based
compensation expense
|
3,721,485 | 3,721,485 | |||||||||||||||||||
Additional
proceeds from the sale of common stock in
|
|||||||||||||||||||||
2006
|
198,500 | 198,500 | |||||||||||||||||||
Net
loss for the period
|
(17,074,051 | ) | (17,074,051 | ) | |||||||||||||||||
Balance
as of December 31, 2007
|
14,372,472 | 1,437 | 36,822,316 | (21,597,820 | ) | 15,225,933 | |||||||||||||||
Common
stock issued as compensation for consulting
|
|||||||||||||||||||||
services
at $3.61 per share
|
200,000 | 20 | 721,980 | 722,000 | |||||||||||||||||
Common
stock issued as compensation for consulting
|
|||||||||||||||||||||
services
at $3.80 per share
|
20,000 | 2 | 75,998 | 76,000 | |||||||||||||||||
Cashless
exercise of warrants
|
112,215 | 11 | (11 | ) | 0 | ||||||||||||||||
Common
stock issued as compensation for consulting
|
|||||||||||||||||||||
services
at $0.32 per share
|
50,000 | 5 | 15,995 | 16,000 | |||||||||||||||||
Reversal
of liability from the sale of common stock in 2006
|
115,400 | 115,400 | |||||||||||||||||||
Warrants
granted for consulting services
|
91,306 | 91,306 | |||||||||||||||||||
Stock-based
compensation expense
|
4,704,039 | 4,704,039 | |||||||||||||||||||
Net
loss for the period
|
(22,987,273 | ) | (22,987,273 | ) | |||||||||||||||||
Balance
as of December 31, 2008
|
14,754,687 | $ | 1,475 | $ | 42,547,023 | $ | (44,585,093 | ) | $ | (2,036,595 | ) |
May
4, 2001 (Date
|
||||||||||||
Years
ended
|
of
Inception) to
|
|||||||||||
December
31,
|
December
31,
|
|||||||||||
2008
|
2007
|
2008
|
||||||||||
Cash
flows used in operating activities
|
||||||||||||
Net
loss for the period
|
$ | (22,987,273 | ) | $ | (17,074,051 | ) | $ | (44,585,093 | ) | |||
Adjustments
to reconcile net loss to net cash (used in) operating
activities:
|
||||||||||||
Stock based
compensation
|
4,704,039 | 3,721,485 | 8,689,775 | |||||||||
Non-employee stock based
compensation
|
91,306 | 2,917,309 | 5,171,226 | |||||||||
Common stock issuance for
consulting services rendered
|
814,000 | 98,000 | 912,000 | |||||||||
Increase in shares
issuable
|
10,153,000 | - | 10,153,000 | |||||||||
Mark to market of shares
issuable
|
(8,583,900 | ) | - | (8,583,900 | ) | |||||||
Depreciation
|
104,660 | 32,093 | 136,848 | |||||||||
Net change in assets and
liabilities:
|
||||||||||||
Increase in
Receivables
|
(87,658 | ) | (87,658 | ) | ||||||||
Decrease (increase) in
prepaid expenses and other current assets
|
148,279 | (318,075 | ) | (260,024 | ) | |||||||
Decrease in other
assets
|
59 | 78 | (863 | ) | ||||||||
Increase (decrease) in
accounts payable and accrued liabilities
|
2,758,704 | (144,241 | ) | 4,632,546 | ||||||||
Increase in deferred
rent
|
148,651 | - | 148,651 | |||||||||
Net
cash used in operating activities
|
(12,736,133 | ) | (10,767,402 | ) | (23,673,492 | ) | ||||||
Cash
flows from investing activities
|
||||||||||||
Capital
expenditures
|
(175,302 | ) | (295,676 | ) | (474,402 | ) | ||||||
Restricted
cash
|
(233,659 | ) | (68,016 | ) | (301,675 | ) | ||||||
Purchase of marketable
securities
|
(8,598,102 | ) | (25,000,000 | ) | (33,598,102 | ) | ||||||
Sale of marketable
securities
|
22,044,286 | 8,598,102 | 30,642,388 | |||||||||
Net
cash provided by (used in) investing activities
|
13,037,223 | (16,765,590 | ) | (3,731,791 | ) | |||||||
Cash
flows from financing activities
|
||||||||||||
Capital stock
issued
|
- | - | 27,549,748 | |||||||||
Advances from related
party
|
- | - | 64,620 | |||||||||
Additional proceeds from
the sale of common stock in 2006
|
- | 198,500 | 198,500 | |||||||||
Net
cash provided by financing activities
|
- | 198,500 | 27,812,868 | |||||||||
Increase
(decrease) in cash during the period
|
301,090 | (27,334,492 | ) | 407,585 | ||||||||
Cash
at beginning of the period
|
106,495 | 27,440,987 | - | |||||||||
Cash
at end of the period
|
$ | 407,585 | $ | 106,495 | $ | 407,585 | ||||||
Supplemental
disclosure of cash flow information; cash paid for:
|
||||||||||||
Interest
|
$ | - | $ | - | $ | - | ||||||
Income
taxes
|
$ | 1,629 | $ | - | $ | 3,229 |
1.
|
NATURE
OF OPERATIONS AND GOING CONCERN
UNCERTAINTY
|
2.
|
DEVELOPMENT STAGE
COMPANY
|
3.
|
SUMMARY
OF ACCOUNTING POLICIES
|
December 31, 2008 | ||||||||||||
Aggregate
Fair
|
Gross
Unrealized
|
Estimated
Fair
|
||||||||||
Value
|
Gains
/ (Losses)
|
Value
|
||||||||||
Commercial
paper
|
$ | 897,993 | $ | - | $ | 897,993 | ||||||
Corporate
securities fixed rate
|
457,930 | - | 457,930 | |||||||||
Total
|
$ | 1,355,923 | $ | - | $ | 1,355,923 |
December
31, 2007
|
||||||||||||
Aggregate
Fair
|
Gross
Unrealized
|
Estimated
Fair
|
||||||||||
Value
|
Gains
/ (Losses)
|
Value
|
||||||||||
Commercial
paper
|
$ | 10,283,818 | $ | - | $ | 10,283,818 | ||||||
Corporate
obligation
|
2,245,770 | - | 2,245,770 | |||||||||
Total
|
$ | 12,529,588 | $ | - | $ | 12,529,588 |
4.
|
LEGAL
PROCEEDINGS
|
5.
|
CASH EQUIVALENTS AND MARKETABLE
SECURITIES
|
6.
|
FAIR
VALUE MEASUREMENTS
|
·
|
Level
I - inputs are unadjusted, quoted prices for identical assets or
liabilities in active markets at the measurement
date.
|
·
|
Level
II - inputs, other than quoted prices included in Level I, that are
observable for the asset or liability through corroboration with market
data at the measurement date.
|
·
|
Level III - unobservable inputs
that reflect management’s best estimate of what market participants would
use in pricing the asset or liability at the measurement
date.
|
Level
I
|
Level
II
|
Level
III
|
Total
|
|||||||||||||
Cash
and cash equivalents
|
$ | 407,585 | $ | - | $ | - | $ | 407,585 | ||||||||
Marketable
securities:
|
||||||||||||||||
Commercial
paper
|
897,993 | - | - | 897,993 | ||||||||||||
Corporate securities fixed
rate
|
457,930 | - | - | 457,930 | ||||||||||||
Money market
fund
|
1,599,791 | - | - | 1,599,791 | ||||||||||||
Restricted
cash
|
301,675 | - | - | 301,675 | ||||||||||||
Total
assets
|
$ | 3,664,974 | $ | - | $ | - | $ | 3,664,974 | ||||||||
Shares
issuable
|
$ | - | $ | 1,569,100 | $ | - | $ | 1,569,100 | ||||||||
Total
liabilities
|
$ | - | $ | 1,569,100 | $ | - | $ | 1,569,100 |
7.
|
LOSS
PER COMMON SHARE
|
Years
ended
|
||||||||
December
31,
|
||||||||
2008
|
2007
|
|||||||
Numerator:
|
||||||||
Net Loss
|
$ | (22,987,273 | ) | $ | (17,074,051 | ) | ||
Denominator:
|
||||||||
Weighted average outstanding
shares of common stock
|
14,604,274 | 14,206,489 | ||||||
Loss per common
share:
|
||||||||
Basic
|
(1.57 | ) | (1.20 | ) | ||||
Diluted
|
$ | (1.57 | ) | $ | (1.20 | ) |
8.
|
INCOME
TAXES
|
2008
|
2007
|
|||||||
Current:
|
||||||||
Federal
|
$ | - | $ | - | ||||
State
|
2 | 2 | ||||||
2 | 2 | |||||||
Deferred:
|
||||||||
Federal
|
- | - | ||||||
State
|
- | - | ||||||
- | - | |||||||
Total income tax
provision
|
$ | 2 | $ | 2 |
2008
|
2007
|
|||||||
Deferred tax
assets:
|
||||||||
Stock based
compensation
|
$ | 5,342 | $ | 3,611 | ||||
Accrued
liability
|
1,145 | 124 | ||||||
Other
|
78 | - | ||||||
Total deferred tax
assets
|
6,565 | 3,735 | ||||||
Deferred tax
liabilities:
|
||||||||
Fixed
assets
|
36 | 6 | ||||||
Prepaid
expenses
|
62 | 155 | ||||||
Total deferred tax
liabilities
|
98 | 161 | ||||||
6,467 | 3,574 | |||||||
Net operating
loss
|
9,660 | 4,834 | ||||||
Research & development
credits
|
1,446 | 599 | ||||||
17,573 | 9,007 | |||||||
Valuation
allowance
|
(17,573 | ) | (9,007 | ) | ||||
Net deferred tax assets or
(liabilities)
|
$ | - | $ | - |
Valuation Allowance on Deferred
Taxes
|
||||||||
(in
thousands)
|
(in
thousands)
|
|||||||
2008
|
2007
|
|||||||
Beginning
balance
|
$ | 9,007 | $ | 1,917 | ||||
Additions
|
8,566 | 7,090 | ||||||
Ending
balance
|
$ | 17,573 | $ | 9,007 |
Years
ended
|
||||||||
12/31/08(%)
|
12/31/07(%)
|
|||||||
Federal statutory
rate
|
(34.00 | ) | (34.00 | ) | ||||
State and local income taxes, net
of federal tax benefits
|
(5.83 | ) | (5.83 | ) | ||||
Permanent
differences
|
5.81 | 0.68 | ||||||
Research & development
credits
|
(3.68 | ) | (2.72 | ) | ||||
Other
|
0.45 | 0.00 | ||||||
Effective tax
benefit
|
(37.25 | ) | (41.87 | ) | ||||
Valuation
allowance
|
37.25 | 41.87 | ||||||
0.00 | 0.00 |
9.
|
PROPERTY AND
EQUIPMENT
|
December
31,
|
||||||||
2008
|
2007
|
|||||||
Property
and equipment
|
$ | 474,402 | $ | 299,100 | ||||
Accumulated
depreciation
|
(136,848 | ) | (32,188 | ) | ||||
Property
and equipment, net
|
$ | 337,554 | $ | 266,912 |
10.
|
SHARES
ISSUABLE
|
11.
|
LEASES
|
Year
ending December 31:
|
||||
2009
|
$ | 215,859 | ||
2010
|
224,650 | |||
2011
|
233,528 | |||
2012
|
242,842 | |||
2013
|
40,735 | ( 1) | ||
Total
minimum payments required
|
$ | 957,614 |
Year
ending December 31:
|
||||
2009
|
135,837 | |||
2010
|
293,722 | |||
2011
|
303,994 | |||
2012
|
314,266 | |||
2013
|
293,009 | (1) | ||
Total
minimum payments required
|
$ | 1,340,828 |
12.
|
NON-CASH
TRANSACTIONS
|
13.
|
INTEREST
INCOME
|
14.
|
OTHER
EXPENSES
|
15.
|
RELATED PARTY
TRANSACTION
|
16.
|
LICENSE
AGREEMENT
|
17.
|
STOCK OPTIONS AND
WARRANTS
|
For
the years ended December 31,
|
||||||||
2008
|
2007
|
|||||||
Expected
dividend yields
|
zero
|
zero
|
||||||
Expected
volatility
|
130-136 | % | 110-136 | % | ||||
Risk-free
interest rate
|
3.53-3.81 | % | 4.18-4.68 | % | ||||
Expected
terms in years
|
2.87-8.96
years
|
6.25-10
years
|
For
the years ended December 31,
|
||||||||
2008
|
2007
|
|||||||
Expected
dividend yields
|
zero
|
zero
|
||||||
Expected
volatility
|
130-136 | % | 117-136 | % | ||||
Risk-free
interest rate
|
1.00-4.69 | % | 3.45-4.65 | % | ||||
Expected
terms in years
|
0.88-8.63
years
|
4.80-9.62
years
|
Weighted
|
||||||||
Average
|
||||||||
Stock
Options
|
Exercise Price
|
|||||||
Outstanding
at December 31, 2005
|
- | $ | - | |||||
Granted
|
1,600,000 | 5.00 | ||||||
Exercised
|
- | - | ||||||
Cancelled
or forfeited
|
- | - | ||||||
Outstanding
at December 31, 2006
|
1,600,000 | 5.00 | ||||||
Granted
|
2,872,500 | 7.00 | ||||||
Exercised
|
- | - | ||||||
Cancelled
or forfeited
|
(675,000 | ) | 6.41 | |||||
Outstanding
at December 31, 2007
|
3,797,500 | 6.26 | ||||||
Granted
|
905,000 | 2.75 | ||||||
Exercised
|
- | - | ||||||
Cancelled
or forfeited
|
(825,000 | ) | 6.52 | |||||
Outstanding
at December 31, 2008
|
3,877,500 | 5.39 | ||||||
Exercisable
at December 31, 2006
|
- | - | ||||||
Exercisable
at December 31, 2007
|
440,000 | 5.61 | ||||||
Exercisable
at December 31, 2008
|
1,000,500 | $ | 5.94 |
Weighted
|
||||||||
Average
|
||||||||
Warrants
|
Exercise Price
|
|||||||
Outstanding
at December 31, 2005
|
- | $ | - | |||||
Granted
|
454,221 | 2.72 | ||||||
Exercised
|
- | - | ||||||
Cancelled
or forfeited
|
- | - | ||||||
Outstanding
at December 31, 2006
|
454,221 | 2.72 | ||||||
Granted
|
422,500 | 7.29 | ||||||
Exercised
|
- | - | ||||||
Cancelled
or forfeited
|
- | - | ||||||
Outstanding
at December 31, 2007
|
876,721 | 4.92 | ||||||
Granted
|
- | - | ||||||
Exercised
|
(325,000 | ) | 1.00 | |||||
Cancelled
or forfeited
|
- | - | ||||||
Outstanding
at December 31, 2008
|
551,721 | 7.24 | ||||||
Exercisable
at December 31, 2006
|
454,221 | 2.72 | ||||||
Exercisable
at December 31, 2007
|
754,221 | 4.42 | ||||||
Exercisable
at December 31, 2008
|
544,221 | $ | 7.22 |
Stock
Options and Warrants |
Unamortized
Compensation
|
|||||||
Outstanding
|
Expense
|
|||||||
January
1, 2008
|
4,674,221 | $ | 18,228,742 | |||||
Granted
in the period
|
905,000 | 542,827 | ||||||
Forfeited
& Cancelled in the period
|
(825,000 | )(1) | (2,392,494 | ) | ||||
Expensed
in the period
|
- | (6,287,049 | ) | |||||
Exercised
in the period
|
(325,000 | )(2) | - | |||||
December
31, 2008
|
4,429,221 | $ | 10,092,026 |
Weighted
|
||||||||
Number
of
|
Average
|
|||||||
Options
and
|
Exercise
|
|||||||
Warrants
|
Price
|
|||||||
Stock Options and Warrants
|
||||||||
Balance
at January 1, 2008
|
4,674,221 | $ | 6.01 | |||||
Granted
|
905,000 | 2.75 | ||||||
Exercised
|
(325,000 | ) | 1.00 | |||||
Forfeited
& Cancelled
|
(825,000 | ) | 6.52 | |||||
Balance
at December 31, 2008
|
4,429,221 | $ | 5.62 |
18.
|
STOCKHOLDERS’ (DEFICIT)
EQUITY
|
19.
|
PRODUCT
DEVELOPMENT AGREEMENT
|
20.
|
SUBSEQUENT EVENTS (UNAUDITED) |
·
|
Reductions
in our labor force – On March 13, 2009, we gave notice of employment
termination to 19 employees. This represents a total work-force reduction
of approximately 73%. We paid accrued vacation benefits of approximately
$70,000 to terminated employees. The layoffs and our other efforts focused
on streamlining our operations designed to reduce our annual expenses by
approximately $3.5 million to a current operating burn rate of
approximately $200,000 per month.
|
·
|
Refocusing
our available assets and employee resources on the development of the
PAK.
|
·
|
Continuing
vigorous efforts to minimize or defer our operating
expenses.
|
·
|
Exploring
various strategic alternatives, which may include the license of certain
of our intellectual property rights, as a means to further develop our
technologies, among other possible transactions and
alternatives.
|
·
|
Intensifying
our search to obtain additional financing to support our operations and to
satisfy our ongoing capital requirements in order to improve our liquidity
position.
|
·
|
Continuing
to prosecute our patents and take other steps to perfect our intellectual
property rights.
|
Name
|
Age
|
Position
|
Director
Since
|
|||
Kelly
J. McCrann
|
53
|
Chairman
of the Board and Chief Executive Officer
|
2007
|
|||
Robert
Weinstein
|
48
|
Chief
Financial Officer and Secretary
|
n/a
|
|||
Victor Gura, M.D.
|
66
|
Chief
Medical and Scientific Officer
|
n/a
|
|||
Terren
S. Peizer
|
49
|
Director
|
2007
|
|||
Hans-Dietrich
Polaschegg, Ph.D.
|
66
|
Director
|
2007
|
|||
Jay
A. Wolf
|
36
|
Director
|
2007
|
|||
Marc
G. Cummins (1)
|
49
|
Director
|
2007
|
·
|
provide
a competitive total compensation package that is competitive within the
medical device industry in which we compete for executive talent, and will
assist in the retention of our executives and motivate them to perform at
a superior level;
|
·
|
link
a substantial part of each of our executive’s compensation to the
achievement of our financial and operating objectives and to the
individual's performance;
|
·
|
provide
long-term incentive compensation that focuses our executives' efforts on
building stockholder value by aligning their interests with our
stockholders; and
|
·
|
provide
incentives that promote executive
retention.
|
·
|
the
recommendations of our management;
|
·
|
benchmarks
provided by generally available compensation surveys;
and
|
·
|
the
experience of the members of our Board of Directors and their knowledge of
compensation paid by comparable companies or companies of similar size or
generally engaged in the healthcare services
business.
|
Name and Principal
Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)
|
Option
Awards
($)(1)
|
Non-Equity
Incentive Plan
Compensation
($)
|
Change in
Pension
Value and
Nonqualified
Deferred
Compensation
Earnings
($)
|
All Other
Compensation
($)
|
Total
($)
|
|||||||||||||||||||||||||
Kelly
J. McCrann,
|
2008
|
80,000
|
—
|
—
|
17,411
|
—
|
—
|
—
|
97,411
|
|||||||||||||||||||||||||
Chairman
& CEO (2)
|
||||||||||||||||||||||||||||||||||
Robert
Weinstein,
|
2008
|
286,500
|
—
|
—
|
449,346
|
—
|
—
|
—
|
735,846
|
|||||||||||||||||||||||||
CFO
& Secretary
|
2007
|
100,128
|
21,400
|
—
|
175,564
|
—
|
—
|
—
|
297,092
|
|||||||||||||||||||||||||
Victor
Gura,
|
2008
|
437,600
|
—
|
—
|
858,246
|
—
|
—
|
18,000
|
(3)
|
1,313,846
|
||||||||||||||||||||||||
Chief
Medical &
|
2007
|
455,000
|
—
|
—
|
855,901
|
—
|
—
|
19,500
|
(3)
|
1,330,401
|
||||||||||||||||||||||||
Scientific
Officer
|
||||||||||||||||||||||||||||||||||
Daniel S.
Goldberger,
|
2008
|
—
|
—
|
—
|
—
|
—
|
—
|
152,500
|
(5)
|
152,500
|
||||||||||||||||||||||||
Former
President,
|
2007
|
219,898
|
—
|
—
|
238,457
|
—
|
—
|
—
|
458,355
|
|||||||||||||||||||||||||
COO
& Interim CEO (4)
|
(1)
|
Represents
the dollar amount recognized for financial statement reporting purposes
with respect to fiscal years 2008 and 2007 in accordance with
SFAS 123(R), and includes amounts from awards granted in and prior to
2008 and 2007. Additional information concerning the Company’s
accounting for stock awards may be found in Note 17, “Stock Options and
Warrants” to our financial statements filed as part of this Annual
Report.
|
(2)
|
Mr.
McCrann was appointed as the Chairman of the Board of Directors and our
CEO on October 2, 2008.
|
(3)
|
Represents
auto allowance that Dr. Gura received in the respective fiscal year
pursuant to his employment agreement
..
|
(4)
|
Mr.
Goldberger resigned as our President and COO on August 10, 2007. Mr.
Goldberger also served as our interim CEO from January to October 2008 and
was paid as an independent
consultant.
|
(5)
|
Represents
compensation that Mr. Goldberger received pursuant to his consulting
agreement as an independent consultant while serving as our interim CEO
from January to October 2008 and providing consulting services thereafter
until December 31, 2008.
|
Estimated Possible Payouts
Under
Non-Equity Incentive Plan
Awards(1)
|
Estimated Future Payouts
Under
Equity Incentive Plan Awards(2)
|
All
Other
Stock
Awards:
Number
|
All
Other
Option
Awards
Number
of
|
Exercise
|
Grant
Date
Fair
Value of
|
|||||||||||||||||||||||||||||||||||||
Name
|
Grant Date
|
Threshold
($)
|
Target
($)
|
Maximum
($)
|
Threshold
($)
|
Target
($)
|
Maximum
($)
|
of
Shares of
Stock
or Units
(#)
|
Securities
Under-
lying
Option
(#)
|
or Base
Price of
Option
Awards
($/Sh)
|
Stock
and
Option
Awards
($)(1)
|
|||||||||||||||||||||||||||||||
Kelly J.
McCrann,
|
||||||||||||||||||||||||||||||||||||||||||
Chairman
& CEO
|
10/02/08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
700,000
|
1.50
|
282,646
|
(1)
|
Represents
the total grant date fair value determined for financial statement
reporting purposes in accordance with SFAS 123(R) for awards granted in
2008.
|
OPTION AWARDS
|
||||||||||||||||||||
Name
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Equity
Incentive Plan
Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
|
Option
Exercise
Price ($)
|
Option
Expiration
Date
|
|||||||||||||||
Kelly
J. McCrann,
Chairman
of the
Board
& CEO
|
— | 700,000 | — | 1.50 |
10/02/18
|
|||||||||||||||
Robert
Weinstein,
CFO
& Secretary
|
75,000 | 225,000 | — | 7.00 |
08/10/17
|
|||||||||||||||
Victor
Gura,
Chief
Medical &
Scientific
Officer
|
250,000 | 250,000 | — | 5.00 |
11/14/16
|
|||||||||||||||
Daniel S.
Goldberger,
Former
President, COO & Interim CEO (1)
|
— | — | — | — | — |
(1)
|
Mr.
Goldberger resigned as our President and COO on August 10, 2007. From
January to October 2008, Mr. Goldberger served as our interim CEO. Mr.
Goldberger also resigned from his position as a member of the Board of
Directors in October 2008. On September 8, 2008, Mr. Goldberger
voluntarily forfeited his remaining 200,000
options.
|
Name
|
Fees Earned
or Paid in
Cash ($)
|
Stock
Awards ($)
|
Option
Awards
($) (1)(7)
|
Non-Equity
Incentive
Plan
Compensation
($)
|
Change in
Pension Value and
Nonqualified
Deferred
Compensation
Earnings ($)
|
All Other
Compensation ($)
|
Total ($)
|
|||||||||||||||||||||
Terren
S. Peizer
|
281,250
|
(2)
|
—
|
822,582
|
—
|
—
|
—
|
1,103,832
|
||||||||||||||||||||
Kelly
J. McCrann
|
—
|
—
|
120,960
|
—
|
—
|
—
|
120,960
|
|||||||||||||||||||||
Hans-Dietrich
Polaschegg
|
60,000
|
(3)
|
—
|
—
|
—
|
—
|
—
|
60,000
|
||||||||||||||||||||
Jay
A. Wolf
|
—
|
—
|
120,818
|
—
|
—
|
—
|
120,818
|
|||||||||||||||||||||
Daniel
Goldberger (4)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Dr.
Victor Gura (5)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Marc
G. Cummins (6)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(1)
|
Represents
the dollar amount recognized for financial statement reporting purposes
with respect to fiscal year 2008 in accordance with SFAS 123(R), and
includes amounts from awards granted in and prior to
2008.
|
(2)
|
Represents
compensation that Mr. Peizer received for his services as Executive
Chairman. Mr. Peizer was paid pursuant to his Executive Chairman Agreement
and as an independent consultant. Mr. Peizer served as our Executive
Chairman until October 2008.
|
(3)
|
Represents
compensation that Dr. Polaschegg received for his research and development
consulting services. Dr. Polaschegg was compensated in accordance with his
month to month consulting agreement and paid as an independent
consultant.
|
(4)
|
On
October 6, 2008, Mr. Goldberger resigned as our interim CEO, and on
October 7, 2008, Mr. Goldberger resigned as a member of the Board. Other
than the options granted to him, which he voluntarily forfeited on
September 8, 2008, Mr. Goldberger did not receive any other compensation
for his services as director.
|
(5)
|
On
October 7, 2008, Dr. Gura resigned as a member of our Board of
Directors. Dr. Gura did not receive any compensation or options for his
services as a director.
|
(6)
|
Mr.
Cummins resigned as a member of our Board of Directors effective March 6,
2009.
|
(7)
|
The
aggregate number of option awards outstanding as of December 31, 2008 for
each of our directors serving in such capacity on such date are as
follows: Mr. Peizer’s - 280,000 stock options which were vested and
exercisable within 60 days of March 23, 2009 and 420,000 stock options
which were unvested and unexercisable of such date, Mr. McCrann - 20,000
stock options which were vested and exercisable within 60 days of March
23, 2009 and 780,000 stock options which were unvested and unexercisable
of such date, Dr. Polaschegg - 0, Mr. Wolf - 40,000 stock options which
were vested and exercisable within 60 days of March 23, 2009 and 60,000
stock options which were unvested and unexercisable of such date, Mr.
Goldberger - 0, Dr. Gura - 250,000 stock options which were vested and
exercisable within 60 days of March 23, 2009 and 250,000 stock options
which were unvested and unexercisable of such date, and Mr. Cummins -
0.
|
Name and Address
of Beneficial Owner (1)
|
Title of Class of Shares
Owned
|
Amount and Nature of
Beneficial Ownership
|
Percent of
Class
|
|||||||
Terren
S. Peizer (2)
|
common
stock
|
6,512,596
|
43.3
|
%
|
||||||
Jay
A. Wolf (3)
|
common
stock
|
397,143
|
2.7
|
%
|
||||||
Victor
Gura (4)
|
common
stock
|
250,000
|
1.7
|
%
|
||||||
Kelly
J. McCrann (5)
|
common
stock
|
120,000
|
*
|
|||||||
Robert
Weinstein (6)
|
common
stock
|
95,000
|
*
|
|||||||
Hans-Dietrich
Polaschegg
|
common
stock
|
—
|
—
|
|||||||
Marc
G. Cummins (7)(8)
|
common
stock
|
1,557,158
|
10.6
|
%
|
||||||
All
directors and named executive officers
as
a group (7 persons)
|
common
stock
|
8,931,897
|
58.9
|
%
|
*
|
Represents
beneficial ownership of less than
1%.
|
(1)
|
Unless
otherwise indicated, the address of all of the above named persons is c/o
Xcorporeal, Inc., 12121 Wilshire Blvd., Suite 350, Los Angeles, California
90025.
|
(2)
|
Includes
6,232,596 shares held of record by Consolidated National, LLC, of which
Mr. Peizer is the sole managing member and beneficial owner. As of
December 31, 2008, shares of our common stock underlying 280,000 stock
options granted to Mr. Peizer’s were vested and exercisable within 60 days
of March 23, 2009.
|
(3)
|
Includes
357,143 shares held of record by Trinad Capital Master Fund Ltd. (the
“Master Fund”), that may be deemed to be beneficially owned by Trinad
Management, LLC, the investment manager of the Master Fund and Trinad
Capital LP; a controlling stockholder of the Master Fund; Trinad Advisors
GP, LLC, the general partner of Trinad Capital LP; and Jay Wolf a director
of the issuer and a managing director of Trinad Management, LLC and a
managing director of Trinad Advisors GP, LLC. Mr. Wolf disclaims
beneficial ownership of the reported securities except to the extent of
his pecuniary interest therein. Also includes 40,000 shares of our common
stock underlying stock options issued to Mr. Wolf’s which were vested and
exercisable within 60 days of March 23,
2009.
|
(4)
|
Represents
shares of our common stock underlying 250,000 stock option granted to Dr.
Gura which were vested and exercisable within 60 days of March 23,
2009.
|
(5)
|
Includes
shares of our common stock underlying 20,000 stock options granted to Mr.
McCrann which were vested and exercisable within 60 days of March 23,
2009.
|
(6)
|
Includes
shares of our common stock underlying 75,000 stock options granted to Mr.
Weinstein which were vested and exercisable within 60 days of March 23,
2009.
|
(7)
|
Mr.
Cummins resigned as a member of our Board of Directors effective March 6,
2009.
|
(8)
|
Represents
shares held of record by Prime Logic Capital, LLC, CPS Opportunities, and
GPC LXI, LLC. Mr. Cummins is a Managing Partner of Prime Capital, LLC. He
disclaims beneficial ownership of the reported securities except to the
extent of his pecuniary interest therein. Excludes warrants to purchase
150,000 shares held by OGT, LLC, an affiliate of Prime Logic, over which
Mr. Cummins disclaims beneficial ownership except to the extent of his
pecuniary interest therein.
|
·
|
information
about the services proposed to be or being provided by or to the related
party or the nature of the
transactions;
|
·
|
the
nature of the transactions and the costs to be incurred by our company or
payments to us;
|
·
|
an
analysis of the costs and benefits associated with the transaction and a
comparison of comparable or alternative services that are available to us
from unrelated parties;
|
·
|
the
business advantage that we would gain by engaging in the
transaction; and
|
·
|
an
analysis of the significance of the transaction to our company and to the
related party.
|
(a)
|
The
Following documents are filed as a part of this
report:
|
1.
|
Financial
Statements
|
2.
|
Financial
Statement Schedules
|
3.
|
Exhibits
required by Item 601 of Regulation
S-K
|
Signature
|
Title(s)
|
Date
|
||
/s/ Kelly J.
McCrann
|
Chairman
of the Board of Directors
|
March
31, 2009
|
||
Kelly
J. McCrann
|
||||
/s/ Terren S. Peizer |
Director
|
March
31, 2009
|
||
Terren S. Peizer | ||||
/s/ Hans-Dietrich Polaschegg,
Ph.D.
|
Director
|
March
31, 2009
|
||
Hans-Dietrich
Polaschegg, Ph.D.
|
||||
/s/ Jay A.
Wolf
|
Director
|
March
31, 2009
|
||
Jay
A. Wolf
|
No.
|
Description
|
|
2.1
|
Merger
Agreement, dated as of September 1, 2006, by and among Xcorporeal,
Inc., NQCI Acquisition Corporation and National Quality Care,
Inc.(1)
|
|
3.1
|
Amended
and Restated Certificate of Incorporation of Xcorporeal, Inc.
(1)
|
|
3.2
|
Amended
and Restated Bylaws of Xcorporeal, Inc. (1)
|
|
4.1
|
Specimen
of Common Stock certificate (1)
|
|
10.1†
|
Form
of Indemnification Agreement for directors (1)
|
|
10.2†
|
Xcorporeal,
Inc. 2007 Incentive Compensation Plan (1)
|
|
10.3
|
License
Agreement, dated as of September 1, 2006 (1)
|
|
10.4†
|
Contribution
Agreement, dated as of August 31, 2006 (1)
|
|
10.5†
|
Employment
Agreement, dated as of November 30, 2006, between Xcorporeal, Inc. and
Victor Gura, M.D. (1)
|
|
10.6
|
Form
of Innovation, Proprietary Information and Confidentiality Agreement
(1)
|
|
10.7†
|
Executive
Chairman Agreement, dated as of August 10, 2007, between Xcorporeal, Inc.
and Terren S. Peizer (1)
|
|
10.8†
|
Employment
Agreement of Robert Weinstein (1)
|
|
10.9†
|
Consulting
Agreement, dated as of October 1, 2007, between Xcorporeal, Inc. and
Hans-Dietrich Polaschegg (1)
|
|
10.10
|
Services
Agreement, dated as of March 22, 2007, between Xcorporeal, Inc. and Aubrey
Group, Inc. (1)
|
|
10.11†
|
Employment
Agreement, dated as of November 30, 2006, between Xcorporeal, Inc. and
Kelly J. McCrann. (2)
|
|
10.12†
|
Services
Agreement, dated as of January 24, 2008, between Xcorporeal, Inc. and
Daniel S. Goldberger (3)
|
|
10.13
|
Lease
for Operating Facility, dated as of October 6, 2008, between Xcorporeal,
Inc. and
Olen
Commercial Realty Corp. (4)
|
|
14.1
|
Code
of Ethics (1)
|
|
21.1
|
Subsidiaries
of Xcorporeal, Inc.*
|
|
23.1
|
Consent
of Independent Registered Public Accounting Firm *
|
|
31.1
|
Rule
13a-14(a) Certification of Chief Executive Officer *
|
|
31.2
|
Rule
13a-14(a) Certification of Chief Financial Officer *
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
*
|
|
32.2
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
*
|
|
* Filed
herewith.
|
|
† Management
contracts, compensatory plans or
arrangements.
|