ý
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QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
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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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(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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(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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(Do
not check if a smaller reporting company)
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PART
I FINANCIAL INFORMATION
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1
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Item
1.
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Financial
Statements.
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1
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Condensed
Balance Sheets (Unaudited) June 30, 2010 and December 31,
2009
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1
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||
Condensed
Statements of Operations (Unaudited) for the Three and Six Months Ended
June 30, 2010 and 2009 and for the Cumulative Period From July 28, 2006
(Inception) Through June 30, 2010
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2
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||
Condensed
Statement of Changes in Stockholders’ Equity (Deficiency) (Unaudited) for
the Six Months Ended June 30, 2010
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3
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Condensed
Statements of Cash Flows (Unaudited) for the Six Months Ended June 30,
2010 and 2009 and for the Cumulative Period From July 28, 2006 (Inception)
Through June 30, 2010
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4
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Notes
to Condensed Financial Statements (Unaudited)
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5
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Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
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12
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Item
3.
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Quantitative
and Qualitative Disclosures About Market Risk.
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19
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Item
4.
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Controls
and Procedures.
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19
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PART
II OTHER INFORMATION
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20
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Item
1.
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Legal
Proceedings.
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20
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Item
1A.
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Risk
Factors.
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20
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds.
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20
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Item
3.
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Defaults
Upon Senior Securities.
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20
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Item
4.
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(Removed
and Reserved).
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20
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Item
5.
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Other
Information.
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20
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Item
6.
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Exhibits.
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21
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SIGNATURES
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22
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Item
1.
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Financial
Statements.
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June
30, 2010
(Unaudited)
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December
31, 2009
(Note
1)
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|||||||
ASSETS
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||||||||
Current
assets
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||||||||
Cash
and cash equivalents
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$ | 10,585,717 | $ | 1,505,179 | ||||
Prepaid
research and development expenses
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230,402 | 175,000 | ||||||
Other
prepaid expenses and current assets
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136,109 | 3,114 | ||||||
Total
current assets
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10,952,228 | 1,683,293 | ||||||
Property
and equipment, net
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25,188 | 24,116 | ||||||
Deferred
financing fees, net
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- | 506,510 | ||||||
Security
deposit
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13,342 | 11,733 | ||||||
TOTAL
ASSETS
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$ | 10,990,758 | $ | 2,225,652 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
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||||||||
Current
liabilities
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||||||||
Accounts
payable
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$ | 803,606 | $ | 549,638 | ||||
Accrued
expenses
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348,127 | 75,000 | ||||||
Senior
convertible notes, net of discount
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- | 12,229,897 | ||||||
Interest
payable – senior convertible notes
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- | 2,393,132 | ||||||
Notes
payable – related parties
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- | 535,428 | ||||||
Interest
payable – related parties
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- | 97,456 | ||||||
Notes
payable – Galenica, Ltd.
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- | 1,000,000 | ||||||
Interest
payable – Galenica, Ltd.
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- | 54,000 | ||||||
Total
current liabilities
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1,151,733 | 16,934,551 | ||||||
Deferred
rent
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19,442 | - | ||||||
TOTAL
LIABILITIES
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1,171,175 | 16,934,551 | ||||||
COMMITMENTS
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||||||||
STOCKHOLDERS’
EQUITY (DEFICIENCY)
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||||||||
Common
stock - $0.001 par value: 40,000,000 shares authorized,
11,408,288 shares issued and outstanding at June 30, 2010; 33,000,000
shares authorized, 787,010 shares issued and outstanding at December 31,
2009
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11,408 | 787 | ||||||
Common
stock – Non-Voting Subordinated Class A, $0.001 par value: none
authorized, issued or outstanding at June 30, 2010; 5,000,000 shares
authorized, 193,936 shares issued and outstanding at December 31,
2009
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- | 194 | ||||||
Deferred
stock issuances
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(27 | ) | (27 | ) | ||||
Additional
paid-in capital
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43,149,266 | 10,621,190 | ||||||
Deficit
accumulated during the development stage
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(33,341,064 | ) | (25,331,043 | ) | ||||
TOTAL
STOCKHOLDERS’ EQUITY (DEFICIENCY)
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9,819,583 | (14,708,899 | ) | |||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
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$ | 10,990,758 | $ | 2,225,652 |
For the Three
Months
Ended June
30, 2010
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For the Three
Months
Ended June
30, 2009
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For the Six
Months
Ended June
30, 2010
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For the Six
Months
Ended June
30, 2009
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Cumulative
Period from
July 28, 2006
(inception)
Through June
30, 2010
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||||||||||||||||
OPERATING
EXPENSES
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||||||||||||||||||||
Research
and development
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$ | 560,690 | $ | 291,189 | $ | 3,657,351 | $ | 524,033 | $ | 16,201,800 | ||||||||||
General
and administrative
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617,775 | 341,438 | 1,264,618 | 746,767 | 6,040,810 | |||||||||||||||
Total
Operating Expenses
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1,178,465 | 632,627 | 4,921,969 | 1,270,800 | 22,242,610 | |||||||||||||||
LOSS
FROM OPERATIONS
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(1,178,465 | ) | (632,627 | ) | (4,921,969 | ) | (1,270,800 | ) | (22,242,610 | ) | ||||||||||
OTHER
INCOME (EXPENSE)
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||||||||||||||||||||
Interest
income
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5,683 | 587 | 5,711 | 2,083 | 94,574 | |||||||||||||||
Interest
expense, including amortization and write-off of deferred financing costs
and debt discounts
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- | (562,287 | ) | (3,093,763 | ) | (1,076,011 | ) | (11,193,028 | ) | |||||||||||
NET
LOSS
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$ | (1,172,782 | ) | $ | (1,194,327 | ) | $ | (8,010,021 | ) | $ | (2,344,728 | ) | $ | (33,341,064 | ) | |||||
NET
LOSS PER SHARE – BASIC AND DILUTED
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$ | (0.10 | ) | $ | (1.42 | ) | $ | (1.20 | ) | $ | (2.78 | ) | ||||||||
WEIGHTED
AVERAGE SHARES OUTSTANDING – BASIC AND DILUTED
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11,408,288 | 842,149 | 6,676,840 | 842,149 |
Common
Stock
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Non-Voting
Common
Stock –
Class
A
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Deferred
Stock
Issuances
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Additional
Paid-in
Capital
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Deficit
Accumulated
During
the
Development
Stage
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Total
Stockholders’ Equity
(Deficiency)
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|||||||||||||||||||||||||||
Shares
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Amount
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Shares
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Amount
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|||||||||||||||||||||||||||||
Balance
at January 1, 2010
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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
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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 February 2010
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24,750 | 25 | (193,936 | ) | (194 | ) | 169 | - | ||||||||||||||||||||||||
Common
stock issued from debt conversion to noteholders in March
2010
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5,914,445 | 5,914 | 18,891,253 | 18,897,167 | ||||||||||||||||||||||||||||
Common
stock issued to licensors at $3.125 per share in March
2010
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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
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3,850,000 | 3,850 | 10,453,420 | 10,457,270 | ||||||||||||||||||||||||||||
Stock-based
compensation
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466,399 | 466,399 | ||||||||||||||||||||||||||||||
Net
Loss
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(8,010,021 | ) | (8,010,021 | ) | ||||||||||||||||||||||||||||
Balance
at June 30, 2010
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11,408,288 | $ | 11,408 | - | $ | - | $ | (27 | ) | $ | 43,149,266 | $ | (33,341,064 | ) | $ | 9,819,583 |
For the Six Months
Ended June 30,
2010
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For the Six Months
Ended June 30,
2009
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Period from
July 28, 2006
(Inception) To
June 30, 2010
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||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
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||||||||||||
Net
loss
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$ | (8,010,021 | ) | $ | (2,344,728 | ) | $ | (33,341,064 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
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||||||||||||
Stock-based
compensation
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466,399 | 40,191 | 931,795 | |||||||||
Stock
issued in connection with license agreements
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2,587,576 | - | 6,983,370 | |||||||||
Stock
issued in connection with consulting agreement
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130,091 | - | 158,262 | |||||||||
Amortization
of deferred financing costs
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358,495 | 94,160 | 2,047,881 | |||||||||
Amortization
of debt discount
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1,135,076 | 385,482 | 4,979,461 | |||||||||
Non-cash
charge for beneficial conversion feature
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1,137,762 | - | 1,137,762 | |||||||||
Non-cash
interest expense
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462,430 | 596,369 | 3,007,017 | |||||||||
Expenses
paid on behalf of the Company satisfied through the issuance of
notes
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- | - | 51,253 | |||||||||
Depreciation
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5,727 | 4,973 | 31,334 | |||||||||
Changes
in operating assets and liabilities:
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||||||||||||
Prepaid
expenses and other current assets
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(188,397 | ) | 72,766 | (366,511 | ) | |||||||
Security
deposits
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(1,609 | ) | - | (13,342 | ) | |||||||
Accounts
payable
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253,968 | (35,872 | ) | 803,606 | ||||||||
Accrued
expenses
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273,128 | - | 348,128 | |||||||||
Deferred
rent
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19,442 | - | 19,442 | |||||||||
Net
cash used in operating activities
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(1,369,933 | ) | (1,186,659 | ) | (13,221,606 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
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||||||||||||
Purchase
of equipment
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(6,799 | ) | - | (56,522 | ) | |||||||
Net
cash used in investing activities
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(6,799 | ) | - | (56,522 | ) | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
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||||||||||||
Proceeds
from notes payable to related parties
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- | - | 2,465,749 | |||||||||
Proceeds
from senior convertible notes
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- | - | 13,364,973 | |||||||||
Proceeds
from Galenica, Ltd. promissory note
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- | - | 1,000,000 | |||||||||
Deferred
financing costs
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- | - | (1,447,400 | ) | ||||||||
Repayment
of amounts loaned under related party notes
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- | - | (1,981,574 | ) | ||||||||
Proceeds
from sale of equity securities, net of issuance costs
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10,457,270 | - | 10,457,270 | |||||||||
Proceeds
from receipt of stock subscriptions and issuances of common
stock
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- | - | 4,827 | |||||||||
Net
cash provided by financing activities
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10,457,270 | - | 23,863,845 | |||||||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
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9,080,538 | (1,186,659 | ) | 10,585,717 | ||||||||
CASH
AND CASH EQUIVALENTS – BEGINNING OF PERIOD
|
1,505,179 | 1,380,012 | - | |||||||||
CASH
AND CASH EQUIVALENTS – END OF PERIOD
|
$ | 10,585,717 | $ | 193,353 | $ | 10,585,717 | ||||||
Cash
paid for interest
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$ | - | $ | - | $ | 18,425 | ||||||
Supplemental
Disclosure of Non-Cash Financing Activities:
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||||||||||||
Conversion
of notes payable and accrued interest to common
stock
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$ | 18,897,167 | $ | - | $ | 18,897,167 | ||||||
Reclassification
of deferred financing fees to additional paid-in capital
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$ | 148,014 | $ | - | $ | 148,014 | ||||||
Stock
issued to technology finders and licensors
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$ | - | $ | - | $ | 155 | ||||||
Warrants
issued to placement agent
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$ | - | $ | - | $ | 748,495 | ||||||
Debt
discount on senior convertible notes
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$ | - | $ | - | $ | 4,979,461 |
Six
Months Ended
June
30, 2010
|
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Expected
Term
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5
years
|
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Volatility
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112%
|
||
Dividend
yield
|
0.0%
|
||
Risk-free
interest rate
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2.6%
|
||
Forfeiture
rate
|
0.0%
|
Six
Months Ended
June
30, 2010
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Six
Months Ended
June
30, 2009
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|||||||||||||||
Shares
|
Weighted
Average
Exercise
Price
|
Shares
|
Weighted
Average
Exercise
Price
|
|||||||||||||
Outstanding
at beginning of period
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23,612 | $ | 8.23 | 23,612 | $ | 8.23 | ||||||||||
Granted
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1,589,215 | $ | 3.125 | - | $ | - | ||||||||||
Outstanding
at end of period and expected to vest
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1,612,827 | $ | 3.20 | 23,612 | $ | 8.23 | ||||||||||
Options
exercisable
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56,380 | $ | 4.61 | 16,380 | $ | 8.23 | ||||||||||
Weighted-average
fair value of options granted during the period
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$ | 2.51 | $ | 6.82 |
Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
Six Months Ended
June 30,
|
Period from July 28,
2006 (Inception)
through June 30, 2010
|
|||||||||||
2010
|
2009
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|||||||||||
CRMD003
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50 | % | 45 | % | 30 | % | ||||||
CRMD001
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47 | % | 50 | % | 66 | % | ||||||
CRMD002
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1 | % | - | % | 1 | % | ||||||
CRMD004
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2 | % | 5 | % | 3 | % |
Item
3.
|
Quantitative
and Qualitative Disclosures About Market
Risk.
|
Item
4.
|
Controls
and Procedures.
|
|
·
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Segregation
of duties - Management implemented internal financial control policies and
procedures for all cash disbursements, including payroll and bank
reconciliations, which require dual approvals, and management now submits
reports on our monthly operational activity report to our Board of
Directors for their independent oversight;
and
|
|
·
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Independent
internal review over financial reporting - Management hired an experienced
outside accounting firm to independently review our financial statements
and 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.*
|
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31.2
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Certification
of Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.*
|
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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.*
|
*
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Filed
herewith.
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CORMEDIX
INC.
|
|||
Date:
August 12, 2010
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By:
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/s/
John C. Houghton
|
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Name:
|
John
C. Houghton
|
||
Title:
|
President
and Chief Executive Officer
|
||
(Principal
Executive Officer)
|
|||
Date:
August 12, 2010
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By:
|
/s/
Brian Lenz
|
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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.
|