x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
FOR
THE QUARTERLY PERIOD ENDED JUNE
30, 2008
|
|
p
|
TRANSITION
REPORT UNDER 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)
|
(IRS
Employer Identification Number)
|
|
o
Large accelerated filer
|
o
Accelerated filer
|
|
|
|
|
|
|
o
Non-accelerated filer
|
x
Smaller reporting company
|
|
Class
|
Outstanding
as of August 6, 2008
|
Common
Stock, $0.0001 par value
|
14,704,687
shares
|
|
PART
I — FINANCIAL INFORMATION
|
2
|
|
|
Item
1. Interim Financial Statements
|
2
|
|
|
Balance
Sheets at June 30, 2008 (unaudited) and December 31, 2007
|
2
|
|
|
Statements
of Operations (unaudited) for the three and six months ended June
30, 2008
and June 30, 2007 and the period from inception (May 4, 2001) to
June 30,
2008
|
3
|
|
|
Statements
of Cash Flows (unaudited) for the six months ended June 30, 2008
and June
30, 2007 and the period from inception (May 4, 2001) to June 30,
2008
|
4
|
|
|
Statement
of Stockholders Equity (Deficit) for the six months ended June 30,
2008
and the period from inception (May 4, 2001) to June 30, 2008
(unaudited)
|
5
|
|
|
Notes
to the Interim Financial Statements
|
6
|
|
|
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
|
16
|
|
|
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
|
18
|
|
|
Item
6. Exhibits
|
18
|
|
|
Signatures
|
19
|
June
30,
|
|
December
31,
|
|
||||
|
|
2008
|
|
2007
|
|||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
|
|||||||
Cash
and cash equivalents
|
$
|
67,987
|
$
|
106,495
|
|||
Marketable
securities, at fair value
|
9,241,096
|
16,401,898
|
|||||
Restricted
cash
|
67,873
|
68,016
|
|||||
Prepaid
Expenses & Other Current Assets
|
361,425
|
408,303
|
|||||
Total
current assets
|
9,738,381
|
16,984,712
|
|||||
Property
and equipment, net
|
320,250
|
266,912
|
|||||
Other
assets
|
892
|
922
|
|||||
Total
Assets
|
$
|
10,059,523
|
$
|
17,252,546
|
|||
LIABILITIES
|
|||||||
Current
|
|||||||
Accounts
payable
|
$
|
1,491,152
|
$
|
1,125,239
|
|||
Accrued
professional fees
|
1,371,905
|
425,228
|
|||||
Accrued
royalties
|
208,333
|
83,333
|
|||||
Accrued
compensation
|
140,946
|
196,541
|
|||||
Accrued
other liabilities
|
105,075
|
68,946
|
|||||
Payroll
liabilities
|
64,505
|
11,926
|
|||||
Deferred
rent
|
38,309
|
-
|
|||||
Other
current liabilities
|
115,400
|
115,400
|
|||||
Total
Current Liabilities
|
3,535,625
|
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,
14,704,687 and 14,372,472 outstanding on
|
|||||||
June
30, 2008 and December 31, 2007, respectively
|
1,470
|
1,437
|
|||||
Additional
paid-in capital
|
39,786,986
|
36,822,316
|
|||||
Deficit
accumulated during the development stage
|
(33,264,558
|
)
|
(21,597,820
|
)
|
|||
Total
Stockholders' Equity
|
6,523,898
|
15,225,933
|
|||||
Total
Liabilities & Stockholders' Equity
|
$
|
10,059,523
|
$
|
17,252,546
|
|
|
|
|
|
|
|
|
May
4, 2001 (Date
|
|
|||||||
|
|
Three
Months Ended
|
|
Six
Months Ended
|
|
of
Inception) to
|
|
|||||||||
|
|
June
30,
|
|
June
30,
|
|
June
30,
|
|
|||||||||
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
2008
|
||||||
Operating
Expenses:
|
||||||||||||||||
Selling,
general and administrative
|
$
|
1,895,013
|
$
|
1,611,188
|
$
|
5,644,652
|
$
|
5,590,288
|
$
|
20,047,344
|
||||||
Research
and development
|
3,473,480
|
1,482,037
|
6,205,972
|
2,688,134
|
14,634,464
|
|||||||||||
Depreciation
and amortization
|
26,076
|
3,862
|
48,584
|
5,383
|
80,850
|
|||||||||||
Loss
before other income and income taxes
|
(5,394,569
|
)
|
(3,097,087
|
)
|
(11,899,208
|
)
|
(8,283,805
|
)
|
(34,762,658
|
)
|
||||||
Interest
and other income
|
78,196
|
308,060
|
234,070
|
619,926
|
1,501,300
|
|||||||||||
Loss
before income taxes
|
(5,316,373
|
)
|
(2,789,027
|
)
|
(11,665,138
|
)
|
(7,663,879
|
)
|
(33,261,358
|
)
|
||||||
Income
taxes
|
-
|
-
|
1,600
|
-
|
3,200
|
|||||||||||
Net
Loss
|
$
|
(5,316,373
|
)
|
$
|
(2,789,027
|
)
|
$
|
(11,666,738
|
)
|
$
|
(7,663,879
|
)
|
$
|
(33,264,558
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.36
|
)
|
$
|
(0.20
|
)
|
$
|
(0.81
|
)
|
$
|
(0.54
|
)
|
||||
Weighted
average number of shares outstanding
|
14,593,485
|
14,200,050
|
14,488,473
|
14,200,050
|
|
|
|
|
May
4, 2001 (Date
|
|
|||||
|
|
Six
Months Ended
|
|
of
Inception) to
|
|
|||||
|
|
June
30,
|
|
June
30,
|
|
|||||
|
|
2008
|
|
2007
|
|
2008
|
||||
Cash
flows used in operating activities
|
||||||||||
Net
Loss for the Period
|
$
|
(11,666,738
|
)
|
$
|
(7,663,879
|
)
|
$
|
(33,264,558
|
)
|
|
Adjustments
to reconcile net loss to net cash (used in) operating
activities:
|
||||||||||
Stock
Based Compensation
|
2,081,958
|
1,483,464
|
6,067,694
|
|||||||
Non-employee
Stock Based Compensation
|
84,745
|
2,795,124
|
5,164,665
|
|||||||
Common
Stock Issuance for consulting services rendered
|
798,000
|
-
|
896,000
|
|||||||
Depreciation
|
48,554
|
5,383
|
80,742
|
|||||||
Net
Change in assets and liabilities:
|
||||||||||
Decrease
(increase) in Prepaid Expenses & Other Current Assets
|
46,878
|
(80,640
|
)
|
(361,425
|
)
|
|||||
Decrease
(increase) in Other Assets
|
30
|
-
|
(892
|
)
|
||||||
Increase
(decrease) in Accounts Payable and Accrued Liabilities
|
1,470,703
|
(815,824
|
)
|
3,344,543
|
||||||
Increase
in Deferred Rent
|
38,309
|
-
|
38,309
|
|||||||
Increase
in Other Current Liabilities
|
-
|
-
|
115,401
|
|||||||
Net
Cash Used in Operating Activities
|
(7,097,561
|
)
|
(4,276,372
|
)
|
(17,919,521
|
)
|
||||
Cash
Flows from Investing Activities
|
||||||||||
Capital
Expenditures
|
(101,892
|
)
|
(58,100
|
)
|
(400,992
|
)
|
||||
Restricted
Cash
|
143
|
(83,050
|
)
|
(67,873
|
)
|
|||||
Purchase
of marketable securities
|
(8,598,102
|
)
|
(25,000,000
|
)
|
(33,598,102
|
)
|
||||
Sale
of marketable securities
|
15,758,904
|
2,323,422
|
24,357,006
|
|||||||
Net
Cash Provided by (Used in) Investing Activities
|
7,059,053
|
(22,817,728
|
)
|
(9,709,961
|
)
|
|||||
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
|
(38,508
|
)
|
(27,094,100
|
)
|
67,987
|
|||||
Cash,
beginning of the period
|
106,495
|
27,440,987
|
-
|
|||||||
Cash,
end of the period
|
$
|
67,987
|
$
|
346,887
|
$
|
67,987
|
||||
Supplemental
disclosure of cash flow information; cash paid for:
|
||||||||||
Interest
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
Income
taxes
|
$
|
1,600
|
$
|
-
|
$
|
3,200
|
|
|
Common
Stock
|
|
AdditionalPaid-in
|
|
Deficit Accumulated |
|
|
|
|||||||
|
|
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 $2,058,024d
|
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
|
||||||||||
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
|
|||||||||||
Warrants
granted for consulting services
|
9,256
|
9,256
|
||||||||||||||
Stock-based
compensation expense
|
960,840
|
960,840
|
||||||||||||||
Net
loss for the period
|
(5,316,373
|
)
|
(5,316,373
|
)
|
||||||||||||
Balance
as of June 30, 2008
|
14,704,687
|
$
|
1,470
|
$
|
39,786,986
|
$
|
(33,264,558
|
)
|
$
|
6,523,898
|
·
|
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
|
$
|
67,987
|
$
|
-
|
$
|
-
|
$
|
67,987
|
|||||
Marketable
securities:
|
|||||||||||||
Commercial
paper
|
3,787,047
|
-
|
-
|
3,787,047
|
|||||||||
Corporate
securities fixed rate
|
660,336
|
-
|
-
|
660,336
|
|||||||||
Money
market fund
|
4,793,713
|
-
|
-
|
4,793,713
|
|||||||||
Restricted
cash
|
67,873
|
-
|
-
|
67,873
|
|||||||||
Total
assets
|
$
|
9,376,956
|
$
|
-
|
$
|
-
|
$
|
9,376,956
|
June
30, 2008
|
||||||||||
Aggregate
FairValue
|
|
Gross
Unrealized Gains / (Losses) |
|
Estimated
Fair Value |
||||||
Commercial
paper
|
3,787,047
|
-
|
3,787,047
|
|||||||
Corporate
securities fixed rate
|
660,336 |
-
|
660,336
|
|||||||
Total
|
$
|
4,447,383
|
$
|
-
|
$
|
4,447,383
|
Property
and equipment
|
$
|
400,992
|
||
Accumulated
depreciation
|
(80,742
|
)
|
||
Property
and equipment, net
|
$
|
320,250
|
Year
ending December 31:
|
|||||||
2008
|
$
|
104,448
|
(1)
|
||||
2009
|
215,859
|
||||||
2010
|
224,650
|
||||||
2011
|
233,528
|
||||||
2012
|
242,842
|
||||||
2013
|
40,735
|
(2)
|
|||||
Total
minimum payments required
|
$
|
1,062,062
|
(
1
) excludes lease payments made through June 30, 2008
|
|||
(
2
) initial term of the lease agreement ends February
2013
|
For
the six months ended
|
||||
June
30, 2008
|
||||
Expected
dividend yields
|
zero
|
|||
Expected
volatility
|
136
|
%
|
||
Risk-free
interest rate
|
3.53-3.81
|
%
|
||
Expected
terms in years
|
10
years
|
For
the six months ended
June
30, 2008
|
||||
Expected
dividend yields
|
zero
|
|||
Expected
volatility
|
136
|
%
|
||
Risk-free
interest rate
|
2.36-4.69
|
%
|
||
Expected
terms in years
|
4.30-9.37
years
|
Stock
Options and Warrants |
|
|
|
Unamortized
Compensation
|
|
|||||
|
|
Outstanding
|
|
|
|
Expense
|
||||
January
1, 2008
|
4,674,221
|
$
|
18,228,742
|
|||||||
Granted
in the period
|
55,000
|
207,447
|
||||||||
Forfeited
in the period
|
(285,000
|
)
|
(1,355,844
|
)
|
||||||
Expensed
in the period
|
-
|
(3,167,215
|
)
|
|||||||
Exercised
in the period
|
(325,000
|
) |
(1)
|
|
-
|
|||||
June
30, 2008
|
4,119,221
|
$
|
13,913,130
|
|
|
|
|
Weighted
|
|
||
|
|
Number
of
|
|
Average
|
|
||
|
|
Options
and
|
|
Exercise
|
|
||
|
|
Warrants
|
|
Price
|
|||
Stock
Options and Warrants
|
|||||||
Balance
at January 1, 2008
|
4,674,221
|
$
|
6.01
|
||||
Granted
|
55,000
|
7.00
|
|||||
Exercised
|
(325,000
|
)
|
1.00
|
||||
Forfeited
|
(285,000
|
)
|
7.00
|
||||
Balance
at June 30, 2008
|
4,119,221
|
$
|
6.35
|
•
|
A
PAK for hospital Renal Replacement Therapy
(RRT);
|
•
|
A
PAK for home hemodialysis; and
|
•
|
A
Wearable Artificial Kidney (WAK) for continuous ambulatory
hemodialysis.
|
Contractual
Obligations and Commercial Commitments
|
||||||||||||||||
Less
than 1
|
More
than 5
|
|||||||||||||||
Contractual
Obligations:
|
Total
|
year
|
1
- 3 years
|
3
- 5 years
|
years
|
|||||||||||
Capital
Lease Obligations
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$ | - | ||||||
Operating
Lease Obligations (1)
|
1,264,424
|
194,649
|
786,199
|
283,576
|
- | |||||||||||
Research
& Development Contractual Commitments
|
162,148
|
162,148
|
-
|
-
|
- | |||||||||||
Other
Liabilities
|
97,167
|
97,167
|
-
|
-
|
- | |||||||||||
$
|
1,523,737
|
$
|
453,963
|
$
|
786,199
|
$
|
283,576
|
$ | - |
June
30, 2008
|
|
|||||||||
|
|
Aggregate
Fair
|
|
Gross
Unrealized
|
|
Estimated
Fair
|
|
|||
|
|
Value
|
|
Gains
/ (Losses)
|
|
Value
|
||||
Commercial
paper
|
3,787,047
|
-
|
3,787,047
|
|||||||
Corporate
securities fixed rate
|
660,336
|
-
|
660,336
|
|||||||
Total
|
$
|
4,447,383
|
$
|
-
|
$
|
4,447,383
|
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:
August 14, 2008
|
By:
|
/s/
Robert Weinstein
|
Robert
Weinstein
Chief
Financial Officer
(Principal
Financial Officer and Principal
Accounting
Officer)
|
||
|
|