Delaware
|
75-2242792
|
(State
or other jurisdiction of
incorporation
or organization)
|
(IRS
Employer Identification Number)
|
£ Large accelerated filer | £ Accelerated filer | ||
£ Non-accelerated filer | x Smaller reporting company |
Class
|
Outstanding
as of May 5, 2008
|
Common
Stock, $0.0001 par value
|
14,592,472
shares
|
PART
I — FINANCIAL INFORMATION
|
3
|
|
|
Item
1. Interim Financial Statements
|
3
|
|
|
Balance
Sheets at March 31, 2008 (unaudited) and December 31, 2007
|
3
|
|
|
Statements
of Operations (unaudited) for the three months ended March 31, 2008
and
March 31, 2007 and the period from inception (May 4, 2001) to March
31,
2008
|
4
|
|
|
Statements
of Cash Flows (unaudited) for the three months ended March 31,
2008 and
March 31, 2007 and the period from inception (May 4, 2001) to March
31,
2008
|
5
|
|
|
Statement
of Stockholders Equity (Deficit) for the three months ended March
31, 2008
and the period from inception (May 4, 2001) to March 31, 2008
(unaudited)
|
6
|
|
|
Notes
to the Interim Financial Statements
|
7
|
|
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
12
|
|
|
Item
3. Quantitative and Qualitative Disclosures about Market
Risk
|
15
|
|
|
Item
4. Controls and Procedures
|
15
|
|
|
PART
II — OTHER INFORMATION
|
17
|
|
|
Item
1. Legal Proceedings
|
17
|
|
|
Item
1A. Risk Factors
|
17
|
|
|
Item
2. Unregistered Sales of Equity Securities ; Use of Proceeds from
Registered Securities
|
17
|
|
|
Item
5. Other Information
|
18
|
|
|
Item
6. Exhibits
|
18
|
|
|
Signatures
|
19
|
March
31,
|
|
December
31,
|
|
||||
|
|
2008
|
|
2007
|
|||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
|
|||||||
Cash
and cash equivalents
|
$
|
19,935
|
$
|
106,495
|
|||
Marketable
securities, at fair value
|
12,952,140
|
16,401,898
|
|||||
Restricted
cash
|
67,943
|
68,016
|
|||||
Prepaid
Expenses & Other Current Assets
|
480,432
|
408,303
|
|||||
Total
current assets
|
13,520,450
|
16,984,712
|
|||||
Property
and equipment, net
|
309,393
|
266,912
|
|||||
Other
assets
|
907
|
922
|
|||||
Total
Assets
|
$ |
13,830,750
|
$
|
17,252,546
|
|||
LIABILITIES
|
|||||||
Current
|
|||||||
Accounts
payable
|
$
|
1,907,106
|
$
|
1,125,239
|
|||
Accrued
compensation
|
115,594
|
196,541
|
|||||
Accrued
professional fees
|
623,141
|
425,228
|
|||||
Accrued
royalties
|
145,833
|
83,333
|
|||||
Accrued
other liabilities
|
114,214
|
68,946
|
|||||
Payroll
liabilities
|
15,287
|
11,926
|
|||||
Other
current liabilities
|
115,400
|
115,400
|
|||||
Total
Current Liabilities
|
3,036,575
|
2,026,613
|
|||||
Commitments
and 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,
14,572,472 and 14,372,472 outstanding on
|
|||||||
March
31, 2008 and December 31, 2007, respectively
|
1,457
|
1,437
|
|||||
Additional
paid-in capital
|
38,740,903
|
36,822,316
|
|||||
Deficit
accumulated during the development stage
|
(27,948,185
|
)
|
(21,597,820
|
)
|
|||
Total
Stockholders' Equity
|
10,794,175
|
15,225,933
|
|||||
Total
Liabilities & Stockholders' Equity
|
$
|
13,830,750
|
$
|
17,252,546
|
|
|
|
|
May
4, 2001 (Date
|
|
|||||
|
|
Three
Months Ended
|
|
of
Inception) to
|
|
|||||
|
|
March
31,
|
|
March
31,
|
|
|||||
|
|
2008
|
|
2007
|
|
2008
|
||||
Operating
Expenses:
|
||||||||||
Selling,general
and administrative
|
$
|
3,749,639
|
$
|
4,041,634
|
$
|
18,152,331
|
||||
Research
and development
|
2,732,492
|
1,143,563
|
11,160,984
|
|||||||
Depreciation
and amortization
|
22,508
|
1,521
|
54,774
|
|||||||
Loss
before other income and income taxes
|
(6,504,639
|
)
|
(5,186,718
|
)
|
(29,368,089
|
)
|
||||
Interest
and other income
|
155,874
|
311,866
|
1,423,104
|
|||||||
Loss
before income taxes
|
(6,348,765
|
)
|
(4,874,852
|
)
|
(27,944,985
|
)
|
||||
Income
taxes
|
1,600
|
-
|
3,200
|
|||||||
Net
Loss
|
$
|
(6,350,365
|
)
|
$
|
(4,874,852
|
)
|
$
|
(27,948,185
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.44
|
)
|
$
|
(0.34
|
)
|
||||
Weighted
average number of shares outstanding
|
14,383,461
|
14,200,050
|
|
|
|
|
May
4, 2001 (Date
|
|
|||||
|
|
Three
Months Ended
|
|
of
Inception) to
|
|
|||||
|
|
March
31,
|
|
March
31,
|
|
|||||
|
|
2008
|
|
2007
|
|
2008
|
||||
Cash
flows used in operating activities
|
||||||||||
Net
Loss for the Period
|
$
|
(6,350,365
|
)
|
$
|
(4,874,852
|
)
|
$
|
(27,948,185
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Non-employee
Stock Based Compensation
|
75,489
|
2,657,635
|
5,155,409
|
|||||||
Stock
Based Compensation
|
1,121,118
|
639,064
|
5,106,854
|
|||||||
Common
Stock Issuance for consulting services rendered
|
722,000
|
-
|
820,000
|
|||||||
Depreciation
and amortization
|
22,493
|
1,521
|
54,681
|
|||||||
Net
Change in assets and liabilities:
|
||||||||||
Increase
in Prepaid Expenses & Other Current Assets
|
(72,129
|
)
|
(44,239
|
)
|
(480,432
|
)
|
||||
(Increase)
decrease in Other Assets
|
15
|
(12,031
|
)
|
(907
|
)
|
|||||
Increase
(decrease) in Accounts Payable and Accrued Liabilities
|
1,009,962
|
(629,658
|
)
|
2,883,802
|
||||||
Increase
in Other Current Liabilities
|
-
|
-
|
115,401
|
|||||||
Net
Cash Used in Operating Activities
|
(3,471,417
|
)
|
(2,262,560
|
)
|
(14,293,377
|
)
|
||||
Cash
Flows from Investing Activities
|
||||||||||
Capital
Expenditures
|
(64,974
|
)
|
(36,062
|
)
|
(364,074
|
)
|
||||
Restricted
Cash
|
73
|
(75,000
|
)
|
(67,943
|
)
|
|||||
Purchase
of marketable securities
|
(8,598,102
|
)
|
(24,623,290
|
)
|
(33,598,102
|
)
|
||||
Sale
of marketable securities
|
12,047,860
|
-
|
20,645,962
|
|||||||
Net
Cash Provided by (Used in) Investing Activities
|
3,384,857
|
(24,734,352
|
)
|
(13,384,157
|
)
|
|||||
Cash
Flows from Financing Activities
|
||||||||||
Capital
Stock issued
|
-
|
-
|
27,434,349
|
|||||||
Advances
from related party
|
-
|
-
|
64,620
|
|||||||
Additional
Proceeds from the Sale of Common Stock in 2006
|
-
|
-
|
198,500
|
|||||||
Net
Cash Provided by Financing Activities
|
-
|
-
|
27,697,469
|
|||||||
Increase/(decrease)
in cash during the period
|
(86,560
|
)
|
(26,996,912
|
)
|
19,935
|
|||||
Cash,
beginning of the period
|
106,495
|
27,440,987
|
-
|
|||||||
Cash,
end of the period
|
$
|
19,935
|
$
|
444,075
|
$
|
19,935
|
||||
Supplemental
disclosure of cash flow information; cash paid for:
|
||||||||||
Interest
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
Income
taxes
|
$
|
1,600
|
$
|
-
|
$
|
3,200
|
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 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
|
||||||||||||
Warrants
granted for consulting services
|
75,489
|
75,489
|
||||||||||||||
Stock-based
compensation expense
|
1,121,118
|
1,121,118
|
||||||||||||||
Net
loss for the period
|
(6,350,365
|
)
|
(6,350,365
|
)
|
||||||||||||
Balance
as of March 31, 2008
|
14,572,472
|
$
|
1,457
|
$
|
38,740,903
|
$
|
(27,948,185
|
)
|
$
|
10,794,175
|
· |
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 he asset or liability at
the
measurement date.
|
Level
I
|
Level
II
|
Level
III
|
Total
|
||||||||||
Cash
and cash equivalents
|
$
|
19,935
|
$
|
-
|
$
|
-
|
$ |
19,935
|
|||||
Marketable
securities:
|
|||||||||||||
Commercial
paper
|
7,561,152
|
-
|
-
|
7,561,152
|
|||||||||
Corporate
obligation
|
831,272
|
-
|
-
|
831,272
|
|||||||||
Money
market fund
|
4,559,716
|
-
|
-
|
4,559,716
|
|||||||||
Restricted
cash
|
67,943
|
-
|
-
|
67,943
|
|||||||||
Total
assets
|
$
|
13,040,018
|
$
|
-
|
$
|
-
|
$ |
13,040,018
|
Property
and equipment
|
$
|
364,074
|
||
Accumulated
depreciation
|
(54,681
|
)
|
||
Property
and equipment, net
|
$
|
309,393
|
For
the three months ended
|
||||
March
31, 2008
|
||||
Expected
dividend yields
|
zero
|
|||
Expected
volatility
|
136
|
%
|
||
Risk-free
interest rate
|
3.81
|
%
|
||
Expected
terms in years
|
10
years
|
For
the three months ended
|
||||
March
31, 2008
|
||||
Expected
dividend yields
|
zero
|
|||
Expected
volatility
|
136
|
%
|
||
Risk-free
interest rate
|
2.36-3.85
|
%
|
||
Expected
terms in years
|
4.58-9.37
years
|
|
|
Stock
Options and
|
|
|
|
||
|
|
Warrants
|
|
Unamortized
Compensation
|
|
||
|
|
Outstanding
|
|
Expense
|
|||
January
1, 2008
|
4,674,221
|
$ | 18,228,742 | ||||
Granted
in the period
|
20,000
|
82,153 | |||||
Forfeited
in the period
|
(15,000
|
)
|
(22,917 | ) | |||
Expensed
in the period
|
-
|
(1,464,034 | ) | ||||
March
31, 2008
|
4,679,221
|
$ | 16,823,944 |
|
|
Weighted
|
|
||||
|
|
Number
of
|
|
Average
|
|
||
|
|
Options
and
|
|
Exercise
|
|
||
|
|
Warrants
|
|
Price
|
|||
Stock
Options and Warrants
|
|||||||
Balance
at January 1, 2008
|
4,674,221
|
$
|
6.01
|
||||
Granted
|
20,000
|
7.00 | |||||
Exercised
|
-
|
- | |||||
Forfeited
|
(15,000
|
)
|
7.00 | ||||
Balance
at March 31, 2008
|
4,679,221
|
$
|
6.01
|
• |
A
PAK for hospital Renal Replacement Therapy
(RRT);
|
• |
A
PAK for home hemodialysis; and
|
• |
A
Wearable Artificial Kidney (WAK) for continuous ambulatory
hemodialysis.
|
Less
than 1
|
More
than 5
|
|||||||||||||||
Contractual
Obligations:
|
Total
|
year
|
1
- 3 years
|
3
- 5 years
|
years
|
|||||||||||
Capital
Lease Obligations
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$ | - | ||||||
Operating
Lease Obligations (1)
|
1,332,778
|
263,003
|
786,199
|
283,576
|
- | |||||||||||
Research
& Development Contractual Commitments
|
342,421
|
342,421
|
-
|
-
|
- | |||||||||||
Other
Liabilities
|
220,806
|
220,806
|
-
|
-
|
- | |||||||||||
$
|
1,896,005
|
$
|
826,231
|
$
|
786,199
|
$
|
283,576
|
$ | - |
No.
|
|
Description
of Exhibit
|
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: May 14, 2008 | By: | /s/ Robert Weinstein |
Robert
Weinstein
Chief
Financial Officer
(Principal
Financial Officer and Principal
Accounting
Officer)
|
||