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ý
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QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
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|
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EXCHANGE
ACT OF 1934
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¨
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
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EXCHANGE
ACT OF 1934
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CORMEDIX
INC.
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|
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(Exact Name of Registrant as
Specified in Its Charter)
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Delaware
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20-5894890
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(State or
Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer Identification
No.)
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745
Rt. 202-206, Suite 303, Bridgewater, NJ
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08807
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|
(Address of Principal Executive
Offices)
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(Zip
Code)
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(908)
517-9500
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(Registrant
’
s Telephone
Number, Including Area
Code)
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|
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_____________________________________________
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|
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(Former Name, Former Address and
Former Fiscal Year, if Changed Since Last
Report)
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Large accelerated
filer
¨
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Accelerated
filer
¨
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|
|
Non-accelerated
filer
¨
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Smaller reporting
company
ý
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|
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(Do not check if a smaller
reporting company)
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|
PART
I FINANCIAL INFORMATION
|
1
|
|
|
Item
1.
|
Financial
Statements.
|
1
|
|
Condensed
Balance Sheets (Unaudited) March 31, 2010 and December 31,
2009
|
1
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|
|
Condensed
Statements of Operations (Unaudited) for the Three Months Ended
March 31, 2010 and 2009 and for the Cumulative Period From
July 28, 2006 (Inception) Through March 31, 2010
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2
|
|
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Condensed
Statement of Stockholders’ Equity (Deficiency) (Unaudited) for the Three
Months Ended March 31, 2010
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3
|
|
|
Condensed
Statements of Cash Flows (Unaudited) for the Three Months Ended
March 31, 2010 and 2009 and for the Cumulative Period From
July 28, 2006 (Inception) Through March 31, 2010
|
4
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|
|
Notes
to Condensed Financial Statements (Unaudited)
|
5
|
|
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Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
12
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk.
|
18
|
|
Item
4.
|
Controls
and Procedures.
|
18
|
|
PART
II OTHER INFORMATION
|
19
|
|
|
Item
1.
|
Legal
Proceedings.
|
19
|
|
Item
1A.
|
Risk
Factors.
|
20
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds.
|
20
|
|
Item
3.
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Defaults
Upon Senior Securities.
|
20
|
|
Item
4.
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(Removed
and Reserved).
|
20
|
|
Item
5.
|
Other
Information.
|
20
|
|
Item
6.
|
Exhibits.
|
20
|
|
SIGNATURES
|
21
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|
|
Item
1.
|
Financial
Statements.
|
|
March
31, 2010
(Unaudited)
|
December
31, 2009
(Note
1)
|
|||||||
|
ASSETS
|
||||||||
|
Current
assets
|
||||||||
|
Cash and cash
equivalents
|
$ | 11,724,713 | $ | 1,505, 179 | ||||
|
Prepaid res
earch and development
expenses
|
175,264 | 175,000 | ||||||
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Other prepaid expenses and current
assets
|
116,483 | 3,114 | ||||||
|
Total current
assets
|
12,016,460 | 1,683,293 | ||||||
|
Pr
operty and equipment,
net
|
28,053 | 24,116 | ||||||
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Deferred financing fees,
net
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- | 506,510 | ||||||
|
Secu
rity
deposits
|
25,075 | 11,733 | ||||||
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TOTAL
ASSETS
|
$ | 12,069,588 | $ | 2,225,652 | ||||
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LIABILITIES AND
STOCKHOLDERS
’
EQUITY
(DEFICIENCY)
|
||||||||
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Current
liabilities
|
||||||||
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Accou
nts payable
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$ | 1,045,746 | $ | 549,638 | ||||
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Accrued
expenses
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375,059 | 75,000 | ||||||
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Senior convertible notes,
ne
t of
discount
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- | 12,229,897 | ||||||
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Interest payable
–
senior convertible
notes
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- | 2,393,132 | ||||||
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Notes payable
–
related
parties
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- | 535,428 | ||||||
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Interest payable
–
related
parties
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- | 97,456 | ||||||
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Notes payable
–
Galenica,
Ltd.
|
- | 1,000,000 | ||||||
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Interest payable
–
Galenica,
Ltd.
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- | 54,000 | ||||||
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TOTAL
LIABILITIES
|
1,420,805 | 16,934,551 | ||||||
|
COMMITMENTS
|
||||||||
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STOCKHOLDERS
’
EQUITY
(DEFICIENCY)
|
||||||||
|
Common stock - $0.001 par
value: 40,000,000 shares authorized, 11,408,288 shares issued
and outstanding at March 31, 2010; 33,000,000 shar
es authorized, 787,010 shares
issued and outstanding at December 31, 2009
|
11,408 | 787 | ||||||
|
Common stock
–
Non-Voting Subordinated Class A,
$0.001 par value: none authorized, issued or outstanding at March 31,
2010; 5,000,000 shares authorized, 193,936 shares i
ssued and outstanding at December
31, 2009
|
- | 194 | ||||||
|
Deferred stock
issuances
|
(27 | ) | (27 | ) | ||||
|
Additional paid-in
capital
|
42,805,684 | 10,621,190 | ||||||
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Deficit accumulated during the
development stage
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(32,168,282 | ) | (25,331,043 | ) | ||||
|
TOTAL STOCKHOLDERS
’
EQUITY
(DEFICIENCY)
|
10,648,783 | (14,708,899 | ) | |||||
|
TOTAL LIABILITIES AND
STOCKHOLDERS
’
EQUITY
(DEFICIENCY)
|
$ | 12,069,588 | $ | 2,225,652 | ||||
|
For
the three months ended March 31, 2010
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For
the three months ended March 31, 2009
|
Period
from July 28, 2006 (inception) Through
March
31, 2010
|
||||||||||
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OPERATING
EXPENSES
|
||||||||||||
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Research
and development
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$ | 3,096,661 | $ | 232,844 | $ | 15,641,110 | ||||||
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General
and administrative
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646,843 | 405,329 | 5,423,035 | |||||||||
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Total
Operating Expenses
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3,743,504 | 638,173 | 21,064,145 | |||||||||
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LOSS
FROM OPERATIONS
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(3,743,504 | ) | (638,173 | ) | (21,064,145 | ) | ||||||
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OTHER
INCOME (EXPENSE)
|
||||||||||||
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Interest
income
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28 | 1,496 | 88,891 | |||||||||
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Interest
expense, including amortization and write-off of
deferred financing costs and debt discounts
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(3,093,763 | ) | (513,724 | ) | (11,193,028 | ) | ||||||
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NET
LOSS
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$ | (6,837,239 | ) | $ | (1,150,401 | ) | $ | (32,168,282 | ) | |||
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NET
LOSS PER SHARE – BASIC AND DILUTED
|
$ | (6.40 | ) | $ | (1.37 | ) | ||||||
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WEIGHTED
AVERAGE SHARES OUTSTANDING – BASIC AND DILUTED
|
1,067,937 | 842,149 | ||||||||||
|
Common
Stock
|
Non-Voting
Common
Stock –
Class
A
|
Deferred
Stock
Issuances
|
Additional
Paid-in
Capital
|
Deficit
Accumulated
During
the
Development
Stage
|
Total
|
|||||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||
|
Balance
at January 1, 2010
|
787,010 | $ | 787 | 193,936 | $ | 194 | $ | (27 | ) | $ | 10,621,190 | $ | (25,331,043 | ) | $ | (14,708,899 | ) | |||||||||||||||
|
Common
stock issued to consultant at $32.05 per share in February
2010
|
4,059 | 4 | 130,087 | 130,091 | ||||||||||||||||||||||||||||
|
Common
stock issued upon conversion of Class A Non Voting Common Stock at a 1 for
7.836 conversion rate in March 2010
|
24,750 | 25 | (193,936 | ) | (194 | ) | 169 | - | ||||||||||||||||||||||||
|
Common
stock issued from debt conversion to noteholders in March
2010
|
5,914,445 | 5,914 | 18,891,253 | 18,897,167 | ||||||||||||||||||||||||||||
|
Common
stock issued to licensors at $3.125 per share in March
2010
|
828,024 | 828 | 2,586,748 | 2,587,576 | ||||||||||||||||||||||||||||
|
Common
stock issued in initial public offering at $3.125 per share in March 2010,
net of issuance costs
|
3,850,000 | 3,850 | 10,453,420 | 10,457,270 | ||||||||||||||||||||||||||||
|
Stock-based
compensation
|
122,817 | 122,817 | ||||||||||||||||||||||||||||||
|
Net
Loss
|
(6,837,239 | ) | (6,837,239 | ) | ||||||||||||||||||||||||||||
|
Balance
at March 31, 2010
|
11,408,288 | $ | 11,408 | - | $ | - | $ | (27 | ) | $ | 42,805,684 | $ | (32,168,282 | ) | $ | 10,648,783 | ||||||||||||||||
|
For
the Three Months Ended March 31, 2010
|
For
the Three Months Ended March 31, 2009
|
Period
from July 28, 2006 (Inception) To March 31,
2010
|
||||||||||
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
|
Net
loss
|
$ | (6,837,239 | ) | $ | (1,150,401 | ) | $ | (32,168,282 | ) | |||
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
|
Stock-based
compensation
|
122,817 | 20,426 | 588,212 | |||||||||
|
Stock
issued in connection with license agreements
|
2,587,576 | - | 6,983,370 | |||||||||
|
Stock
issued in connection with consulting agreement
|
130,091 | - | 158,262 | |||||||||
|
Amortization
of deferred financing costs
|
358,495 | 51,879 | 2,047,881 | |||||||||
|
Amortization
of debt discount
|
1,135,076 | 186,805 | 4,979,461 | |||||||||
|
Non-cash
charge for beneficial conversion feature
|
1,137,762 | - | 1,137,762 | |||||||||
|
Non-cash
interest expense
|
462,429 | 275,040 | 3,007,017 | |||||||||
|
Expenses
paid on behalf of the Company satisfied through the issuance of
notes
|
- | - | 51,253 | |||||||||
|
Depreciation
|
2,864 | 2,487 | 28,471 | |||||||||
|
Changes
in operating assets and liabilities:
|
||||||||||||
|
Prepaid
expenses and other current assets
|
(113,633 | ) | 1,650 | (291,747 | ) | |||||||
|
Security
deposits
|
(13,342 | ) | - | (25,075 | ) | |||||||
|
Accounts
payable
|
496,108 | 70,925 | 1,045,746 | |||||||||
|
Accrued
expenses
|
300,059 | - | 375,059 | |||||||||
|
Net
cash used in operating activities
|
(230,937 | ) | (541,189 | ) | (12,082,610 | ) | ||||||
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
|
Purchase
of equipment
|
(6,799 | ) | - | (56,522 | ) | |||||||
|
Net
cash used in investing activities
|
(6,799 | ) | - | (56,522 | ) | |||||||
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
|
Proceeds
from notes payable to related parties
|
- | - | 2,465,749 | |||||||||
|
Proceeds
from senior convertible notes
|
- | - | 13,364,973 | |||||||||
|
Proceeds
from Galenica, Ltd. promissory note
|
- | - | 1,000,000 | |||||||||
|
Deferred
financing costs
|
- | - | (1,447,400 | ) | ||||||||
|
Repayment
of amounts loaned under related party notes
|
- | - | (1,981,574 | ) | ||||||||
|
Proceeds
from sale of equity securities, net of issuance costs
|
10,457,270 | - | 10,457,270 | |||||||||
|
Proceeds
from receipt of stock subscriptions and issuances of common
stock
|
- | - | 4,827 | |||||||||
|
Net
cash provided by financing activities
|
10,457,270 | - | 23,863,845 | |||||||||
|
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
10,219,534 | (541,189 | ) | 11,724,713 | ||||||||
|
CASH
AND CASH EQUIVALENTS – BEGINNING OF PERIOD
|
1,505,179 | 1,380,012 | - | |||||||||
|
CASH
AND CASH EQUIVALENTS – END OF PERIOD
|
$ | 11,724,713 | $ | 838,823 | $ | 11,724,713 | ||||||
|
Supplemental
Disclosure of Non-Cash Financing Activities:
|
||||||||||||
|
Conversion
of notes payable and accrued interest to common
stock
|
$ | 18,897,167 | $ | - | $ | 18,897,167 | ||||||
|
Reclassification
of deferred financing fees to additional paid-in capital
|
$ | 148,014 | $ | - | $ | 148,014 | ||||||
|
Three
Months Ended
March
31, 2010
|
|
|
Expected
Term
|
5
years
|
|
Volatility
|
112%
|
|
Dividend
yield
|
0.0%
|
|
Risk-free
interest rate
|
2.6%
|
|
Forfeiture
rate
|
0.0%
|
|
Three
Months Ended
March 31,
2010
|
Three
Months Ended
March 31,
2009
|
|||||||||||||||
|
Shares
|
Weighted
Average
Exercise
Price
|
Shares
|
Weighted
Average
Exercise
Price
|
|||||||||||||
|
Outstanding
at beginning of period
|
23,612 | $ | 8.23 | 23,612 | $ | 8.23 | ||||||||||
|
Granted
|
1,581,766 | $ | 3.125 | - | $ | - | ||||||||||
|
Outstanding
at end of period and expected to vest
|
1,605,378 | $ | 3.20 | 23,612 | $ | 8.23 | ||||||||||
|
Options
exercisable
|
56,380 | $ | 4.61 | 16,380 | $ | 8.23 | ||||||||||
|
Weighted-average
fair value of options granted during the period
|
$ | 2.51 | $ | 8.23 | ||||||||||||
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
|
Three
Months Ended
March 31,
|
Period
from July 28,
2006
(Inception)
through
March 31, 2010
|
||
|
2010
|
2009
|
||
|
CRMD003
|
51%
|
65%
|
28%
|
|
CRMD001
|
47%
|
34%
|
62%
|
|
CRMD002
|
1%
|
-%
|
7%
|
|
CRMD004
|
1%
|
1%
|
3%
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market
Risk.
|
|
Item
4.
|
Controls
and Procedures.
|
|
|
·
|
lack
of segregation of duties in certain accounting processes, including the
approval and execution of disbursements, as a result of the absence of
internal review procedures with respect to such processes;
and
|
|
|
·
|
lack
of independent internal review over financial
reporting.
|
|
|
·
|
Segregation
of duties - We are in the process of establishing procedures whereby both
our Chief Executive Officer and Chief Financial Officer are required to
sign for cash disbursements above a certain amount, and both our Chief
Executive Officer and Chief Financial Officer review our cash
disbursements, payroll registers and banking
transactions.
|
|
|
·
|
Independent
internal review over financial reporting - We intend to hire an outside
consultant to independently review our quarterly and annual financial
statements as well as our accounting for non-routine complex
transactions.
|
|
Item
1.
|
Legal
Proceedings.
|
|
Item
1A.
|
Risk
Factors.
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
Proceeds.
|
|
Item
3.
|
Defaults
Upon Senior Securities.
|
|
Item
4.
|
(Removed
and Reserved).
|
|
Item
5.
|
Other
Information.
|
|
Item
6.
|
Exhibits.
|
|
Exhibit
Number
|
Description
|
|
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, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.*
|
|
32.2
|
Certification
of Principal 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.
|
|
CORMEDIX
INC.
|
|||
|
Date: May
11, 2010
|
By:
|
/s/
John C. Houghton
|
|
|
Name:
|
John
C. Houghton
|
||
|
Title:
|
President
and Chief Executive Officer
|
||
|
(Principal
Executive Officer)
|
|||
|
Date: May
11, 2010
|
By:
|
/s/
Brian Lenz
|
|
|
Name:
|
Brian
Lenz
|
||
|
Title:
|
Chief
Financial Officer
|
||
|
(Principal
Financial and Accounting Officer)
|
|||
|
Exhibit
Number
|
Description
|
|
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, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.*
|
|
32.2
|
Certification
of Principal 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.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|