Delaware
|
75-2242792
|
(State
or other jurisdiction of
incorporation
or organization)
|
(IRS
Employer Identification Number)
|
Class
|
Outstanding
as of November 8, 2007
|
Common
Stock, $0.0001 par value
|
14,351,491
shares
|
PART
I — FINANCIAL INFORMATION
|
|
Item
1. Interim Financial Statements
|
3
|
Balance
Sheets at September 30, 2007 (unaudited) and December 31,
2006
|
3
|
Statements
of Operations (unaudited) for the three and nine months ended September
30, 2007 and September 30, 2006 and the period from inception (May
4,
2001) to September 30, 2007
|
4
|
Statement
of Stockholders Equity (Deficit) for the nine months ended September
30,
2007 and the period from inception (May 4, 2001) to September 30,
2007
(unaudited)
|
5
|
Statements
of Cash Flows (unaudited) for the nine months ended September 30,
2007 and
September 30, 2006 and the period from inception (May 4, 2001) to
September 30, 2007
|
6
|
Notes
to the Interim Financial Statements
|
7
|
Item
2. Management’s Discussion and Analysis or Plan of
Operation
|
11
|
Item
3. Controls and Procedures
|
18
|
PART
II — OTHER INFORMATION
|
19
|
Item
1. Legal Proceedings
|
19
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
24
|
Item
4. Submission of Matters to a Vote of Security Holders
|
24
|
Item
6. Exhibits
|
24
|
Signatures
|
25
|
September
30,
|
December
31,
|
||||||
2007
|
2006
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
|
|||||||
Cash
and cash equivalents
|
$
|
672,271
|
$
|
27,440,987
|
|||
Marketable
securities, at fair value
|
19,609,317
|
-
|
|||||
Restricted
cash
|
87,996
|
-
|
|||||
Prepaid
Expenses & Other Current Assets
|
314,163
|
90,228
|
|||||
Total
current assets
|
20,683,747
|
27,531,215
|
|||||
Property
and equipment, net
|
196,087
|
3,328
|
|||||
Other
assets
|
936
|
1,000
|
|||||
Total
Assets
|
$
|
20,880,770
|
$
|
27,535,543
|
|||
LIABILITIES
|
|||||||
Current
|
|||||||
Accounts
payable
|
$
|
1,314,373
|
$
|
143,606
|
|||
Accrued
placement agent fees
|
-
|
1,348,470
|
|||||
Accrued
professional fees
|
582,668
|
312,208
|
|||||
Accrued
royalties
|
270,833
|
83,333
|
|||||
Accrued
other liabilities
|
173,456
|
121,189
|
|||||
Other
current liabilities
|
115,400
|
124,676
|
|||||
Total
Current Liabilities
|
2,456,730
|
2,133,482
|
|||||
Commitments
and contingencies
|
|||||||
STOCKHOLDERS'
EQUITY
|
|||||||
Preferred
Stock, $0.001 par value, 10,000,000 shares
|
|||||||
authorized,
none outstanding
|
-
|
-
|
|||||
Common
Stock, $0.0001 par value, 40,000,000 shares
|
|||||||
authorized,
14,000,050 and 14,200,050 outstanding on
|
|||||||
September
30, 2007 and December 31, 2006,
|
|||||||
respectively
|
1,400
|
1,420
|
|||||
Additional
paid-in capital
|
35,081,012
|
29,924,410
|
|||||
Deficit
accumulated during the development stage
|
(16,658,372
|
)
|
(4,523,769
|
)
|
|||
Total
Stockholders' Equity
|
18,424,040
|
25,402,061
|
|||||
Total
Liabilities & Stockholders' Equity
|
$
|
20,880,770
|
$
|
27,535,543
|
May
4, 2001 (Date
|
||||||||||||||||
Three
Months Ended
|
Nine
Months Ended
|
of
Inception) to
|
||||||||||||||
September
30,
|
September
30,
|
September
30,
|
||||||||||||||
2007
|
2006
|
2007
|
2006
|
2007
|
||||||||||||
Operating
Expenses:
|
||||||||||||||||
Selling,
general and administrative
|
$
|
2,664,405
|
$
|
2,307,727
|
$
|
8,254,693
|
$
|
2,319,517
|
$
|
11,573,345
|
||||||
Research
and development
|
2,087,753
|
917,630
|
4,775,887
|
917,630
|
6,063,209
|
|||||||||||
Depreciation
and amortization
|
9,243
|
-
|
14,626
|
-
|
14,721
|
|||||||||||
Loss
before interest income and income taxes
|
(4,761,401
|
)
|
(3,225,357
|
)
|
(13,045,206
|
)
|
(3,237,147
|
)
|
(17,651,275
|
)
|
||||||
Interest
income
|
290,677
|
-
|
910,603
|
-
|
992,903
|
|||||||||||
Loss
before income taxes
|
(4,470,724
|
)
|
(3,225,357
|
)
|
(12,134,603
|
)
|
(3,237,147
|
)
|
(16,658,372
|
)
|
||||||
Income
taxes
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
Net
Loss
|
$
|
(4,470,724
|
)
|
$
|
(3,225,357
|
)
|
$
|
(12,134,603
|
)
|
$
|
(3,237,147
|
)
|
$
|
(16,658,372
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.32
|
)
|
$
|
(0.55
|
)
|
$
|
(0.86
|
)
|
$
|
(0.72
|
)
|
||||
Weighted
average number of shares outstanding
|
14,089,180
|
5,835,217
|
14,162,687
|
4,499,121
|
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 a licence rights
|
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
|
-
|
-
|
|||||||||
Warrants
granted for consulting services
|
2,233,238
|
2,233,238
|
||||||||||||||
Stock-based
compensation expense
|
2,923,344
|
2,923,344
|
||||||||||||||
Net
loss for the period
|
(12,134,603
|
)
|
(12,134,603
|
)
|
||||||||||||
Balance
as of September 30, 2007
|
14,000,050
|
$
|
1,400
|
$
|
35,081,012
|
$
|
(16,658,372
|
)
|
$
|
18,424,040
|
May
4, 2001 (Date
|
||||||||||
Nine
Months Ended
|
of
Inception) to
|
|||||||||
September
30,
|
September
30,
|
|||||||||
2007
|
2006
|
2007
|
||||||||
Cash
flows used in operating activities
|
||||||||||
Net
Loss for the Period
|
$
|
(12,134,603
|
)
|
$
|
(3,237,147
|
)
|
$
|
(16,658,372
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Non-employee
Stock Based Compensation
|
2,923,344
|
2,162,611
|
5,085,955
|
|||||||
Stock
Based Compensation
|
2,233,238
|
-
|
2,497,489
|
|||||||
Depreciation
and amortization
|
14,626
|
-
|
14,721
|
|||||||
Net
Change in assets and liabilities:
|
||||||||||
Prepaid
Expenses & Other Current Assets
|
(223,935
|
)
|
-
|
(314,163
|
)
|
|||||
Other
Assets
|
-
|
-
|
(1,000
|
)
|
||||||
Accounts
Payable and Accrued Liabilities
|
332,524
|
1,044,143
|
2,341,329
|
|||||||
Other
Current Liabilities
|
(9,276
|
)
|
-
|
115,400
|
||||||
Net
Cash Used in Operating Activities
|
(6,864,082
|
)
|
(30,393
|
)
|
(6,918,641
|
)
|
||||
Cash
Flows from Investing Activities
|
||||||||||
Capital
Expenditures
|
(207,321
|
)
|
-
|
(210,744
|
)
|
|||||
Restricted
Cash
|
(87,996
|
)
|
-
|
(87,996
|
)
|
|||||
Purchase
of marketable securities
|
(21,932,739
|
)
|
-
|
(21,932,739
|
)
|
|||||
Sale
of marketable securities
|
2,323,422
|
-
|
2,323,422
|
|||||||
Net
Cash Used in Investing Activities
|
(19,904,634
|
)
|
-
|
(19,908,057
|
)
|
|||||
Cash
Flows from Financing Activities
|
||||||||||
Capital
Stock issued
|
-
|
-
|
27,434,349
|
|||||||
Advances
from related party
|
-
|
30,393
|
64,620
|
|||||||
Net
Cash Provided by Financing Activities
|
-
|
30,393
|
27,498,969
|
|||||||
Increase/(decrease)
in cash during the period
|
(26,768,716
|
)
|
-
|
672,271
|
||||||
Cash,
beginning of the period
|
27,440,987
|
-
|
-
|
|||||||
Cash,
end of the period
|
$
|
672,271
|
$
|
-
|
$
|
672,271
|
||||
Supplemental
disclosure of cash flow information; cash paid for:
|
||||||||||
Interest
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
Income
taxes
|
$
|
-
|
$
|
-
|
$
|
-
|
Property
and equipment
|
$
|
210,744
|
||
Accumulated
depreciation
|
(14,657
|
)
|
||
Property
and equipment, net
|
$
|
196,087
|
|
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
May
4, 2001
(Date
of
Inception)
to
September
30,
|
|||||||||||||
2007
|
2006
|
2007
|
2006
|
2007
|
||||||||||||
Administrative
services
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
3,000
|
$
|
12,000
|
For
the nine months
|
||||
ended
|
||||
September
30, 2007
|
||||
Expected
dividend yields
|
zero
|
|||
Expected
volatility
|
110
|
%
|
||
Risk-free
interest rate
|
4.68
|
%
|
||
Expected
terms in years
|
6.25-6.50
|
September
30, 2007
|
||||
Expected
dividend yields
|
zero
|
|||
Expected
volatility
|
135
|
%
|
||
Risk-free
interest rate
|
4.59
|
%
|
||
Expected
terms in years
|
9.86
|
|
|
|
Stock
Options
|
||||
|
and
|
Unamortized
|
|||||
Warrants
|
Compensation
|
||||||
Outstanding
|
Expense
|
||||||
January
1, 2007
|
2,054,221
|
$
|
10,002,154
|
||||
Granted
in the period
|
2,985,000
|
18,321,060
|
|||||
Forfeited
in the period
|
(405,000
|
)
|
(2,721,499
|
)
|
|||
Expensed
in the period
|
(5,156,582
|
)
|
|||||
September
30, 2007
|
4,634,221
|
$
|
20,445,133
|
Number
of
|
Weighted
|
||||||
|
Options
|
Average
|
|||||
and
|
Exercise
|
||||||
|
Warrants
|
Price
|
|||||
Stock
Options and Warrants
|
|||||||
Balance
at January 1, 2007
|
2,054,221
|
$
|
4.50
|
||||
Granted
|
2,985,000
|
$
|
7.00
|
||||
Exercised
|
-
|
$
|
-
|
||||
Forfeited
|
(405,000
|
)
|
$
|
6.01
|
|||
Balance
at September 30, 2007
|
4,634,221
|
$
|
5.98
|
||||
Options
and warrants exercisable at September 30, 2007
|
4,634,221
|
$
|
5.98
|
· |
Portable
Artificial Kidney (PAK) dialysis device for use in the hospital for
the
treatment of acute renal failure
|
· |
PAK
for use in the home for chronic treatment of End Stage Renal Disease
(ESRD)
|
· |
Wearable
Artificial Kidney (WAK) for chronic treatment of
ESRD.
|
•
|
Raised
over $29 million in equity financing in the fourth quarter of 2006
selling
shares of Xcorporeal common stock at $7.00 per share.
|
•
|
Recruited
experienced independent board members
|
•
|
Recruited
top industry management team and scientific staff
|
•
|
Advanced
the clinical studies for our technology
|
•
|
Paid
in excess of $1 million in licensed product development expenses.
|
•
|
Its
reduced size, weight, and power consumption allows us to deploy a
wearable
package so that the treatment does not interfere with normal activities
of
daily life.
|
•
|
Its
utilization of sorbents to regenerate the dialysate fluid and thus
afford
a considerable reduction in the amount of dialysate required for
each
treatment.
|
•
|
Improving
the chemicals used in the regeneration of the dialysis fluid. The
current
chemicals have been used for decades. We believe new chemicals that
last
longer and can be used in smaller quantities would further reduce
the cost
and weight of our product.
|
•
|
Developing
software to allow physicians to customize the function of the device
to
meet the specific dialysis needs of each patient.
|
•
|
Adapting
the extra-corporeal platform technology underlying our Wearable Artificial
Kidney to other medical uses. We believe our technology is a platform
for
a number of other devices that can be used to treat other diseases
and
will offer substantive value propositions for patients and healthcare
providers.
|
•
|
Expanding
our recruiting and retaining an experienced team of scientists and
engineers.
|
No.
|
Description
of Exhibit
|
2.1
|
Merger
Agreement
|
3.1
|
Amended
and Restated Certificate of Incorporation
|
3.2
|
Bylaws
|
4.1
|
Specimen
of common stock certificate
|
10.1*
|
Form
of Indemnification Agreement for directors
|
10.2*
|
Form
of 2007 Incentive Compensation Plan
|
10.3
|
License
Agreement
|
10.4
|
Contribution
Agreement
|
10.5*
|
Employment
Agreement of Victor Gura, M.D.
|
10.6
|
Form
of Innovation, Proprietary Information and Confidentiality Agreement
|
10.7*
|
Executive
Chairman Agreement of Terren S. Peizer
|
10.8*
|
Employment
Agreement of Robert Weinstein
|
10.9
|
Consulting
Agreement of Dr. Hans-Dietrich Polaschegg
|
10.10
|
Services
Agreement with Aubrey Group, Inc.
|
14.1
|
Code
of Ethics
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
Date: November 12, 2007 | By: | /s/ ROBERT WEINSTEIN |
Robert
Weinstein
Chief
Financial Officer
(Principal
Financial Officer and Principal
Accounting
Officer)
|