Cytosorbents Corp - Quarter Report: 2010 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
x QUARTERLY REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
For the
quarterly period ended June 30,
2010
or
o TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE
ACT OF 1934
For the
transition period from __________ to __________
Commission
file number: 000-51038
CYTOSORBENTS
CORPORATION
(f/k/a MedaSorb Technologies
Corporation)
(Exact
Name of Registrant as Specified in Its Charter)
Nevada
|
98-0373793
|
(State
or Other Jurisdiction of
Incorporation
Or Organization)
|
(I.R.S.
Employer Identification No.)
|
7 Deer Park Drive, Suite K,
Monmouth Junction, New Jersey 08852
(Address
of Principal Executive Offices)
(732)
329-8885
(Registrant’s
Telephone Number, Including Area Code)
MEDASORB
TECHNOLOGIES CORPORATION
(FORMER
NAME OR FORMER ADDRESS, IF CHANGED SINCE LAST REPORT)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90
days. þ Yes
¨
No
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Indicate
by check mark whether the Registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
definition of “accelerated filer, large accelerated filer”, and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
|
Non-accelerated
filer ¨ (Do
not check if a smaller
reporting company)
|
Smaller
reporting company þ
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). ¨ Yes þ No
As of
August 18, 2010 there were 106,118,764 shares of the issuer’s common stock
outstanding.
CytoSorbents
Corporation
(a
development stage company)
FORM
10-Q
TABLE
OF CONTENTS
Page
|
|
PART
I. FINANCIAL INFORMATION
|
|
Item
1. Financial Statements (June 30, 2010 and 2009 are
unaudited)
|
|
Consolidated
Balance Sheets
|
3
|
Consolidated
Statements of Operations
|
4
|
Consolidated
Statements of Changes in Stockholders’ Equity (Deficit)
|
5
|
Consolidated
Statements of Cash Flows
|
6
|
Notes
to Consolidated Financial Statements
|
8
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
16
|
Item
3. Quantitative and Qualitative Disclosures about Market
Risk
|
18
|
Item
4(T). Controls and Procedures
|
18
|
PART
II. OTHER INFORMATION
|
|
Item
1. Legal Proceedings
|
19
|
Item
1A. Risk Factors
|
19
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
19
|
Item
3. Defaults of Senior Securities
|
19
|
Item
4. (Removed and Reserved)
|
19
|
Item
5. Other Information
|
19
|
Item
6. Exhibits
|
19
|
2
PART
I — FINANCIAL INFORMATION
Item
1. Financial Statements.
CYTOSORBENTS
CORPORATION
(f/k/a
MedaSorb Technologies Corporation)
(a
development stage company)
CONSOLIDATED
BALANCE SHEETS
June 30,
|
December 31,
|
|||||||
|
2010
|
2009
|
||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
and cash equivalents
|
$
|
595,524
|
$
|
1,595,628
|
||||
Prepaid
expenses and other current assets
|
79,286
|
369,091
|
||||||
Total
current assets
|
674,810
|
1,964,719
|
||||||
Property
and equipment – net
|
14,225
|
18,853
|
||||||
Other
assets
|
263,800
|
254,908
|
||||||
Total
long-term assets
|
278,025
|
273,761
|
||||||
Total
Assets
|
$
|
952,835
|
$
|
2,238,480
|
||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$
|
820,154
|
$
|
852,167
|
||||
Accrued
expenses and other current liabilities
|
231,650
|
118,598
|
||||||
Notes
payable
|
172,500
|
—
|
||||||
Total
current liabilities
|
1,224,304
|
970,765
|
||||||
Total
liabilities
|
1,224,304
|
970,765
|
||||||
Stockholders’
Equity (Deficit):
|
||||||||
10%
Series B Preferred Stock, Par Value $0.001, 200,000 shares authorized at
June 30, 2010 and December 31, 2009, respectively; 61,591.08 and 68,723.88
shares issued and outstanding, respectively
|
62
|
69
|
||||||
10%
Series A Preferred Stock, Par Value $0.001, 12,000,000 shares authorized
at June 30, 2010 and December 31, 2009, respectively; 6,018,071 and
6,255,813 shares issued and outstanding, respectively
|
6,018
|
6,256
|
||||||
Common
Stock, Par Value $0.001, 500,000,000 shares authorized at June 30, 2010
and December 31, 2009, 101,502,222 and 66,374,856 shares issued and
outstanding, respectively
|
101,502
|
66,375
|
||||||
Additional
paid-in capital
|
81,363,850
|
80,097,536
|
||||||
Deficit
accumulated during the development stage
|
(81,742,901
|
)
|
(78,902,521
|
)
|
||||
Total
stockholders' equity (deficit)
|
(271,469
|
)
|
1,267,715
|
|||||
Total
Liabilities and Stockholders' Equity (Deficit)
|
$
|
952,835
|
$
|
2,238,480
|
See
accompanying notes to consolidated financial statements.
3
CYTOSORBENTS
CORPORATION
(f/k/a
MedaSorb Technologies Corporation)
(a
development stage company)
CONSOLIDATED
STATEMENTS OF OPERATIONS
Period
from
|
||||||||||||||||||||
January
|
||||||||||||||||||||
22,
1997
|
||||||||||||||||||||
(date of
|
||||||||||||||||||||
inception)
|
||||||||||||||||||||
to
|
Six months
|
Three months
|
||||||||||||||||||
June
|
ended June
30,
|
ended June
30,
|
||||||||||||||||||
30,
2010
|
2010
|
2009
|
2010
|
2009
|
||||||||||||||||
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
||||||||||||||||
Revenue
|
$ | -- | $ | -- | $ | -- | $ | -- | $ | -- | ||||||||||
Expenses:
|
||||||||||||||||||||
Research
and development
|
47,287,826 | 1,034,103 | 1,069,931 | 352,888 | 581,376 | |||||||||||||||
Legal,
financial and other consulting
|
7,508,355 | 200,378 | 127,772 | 127,446 | 79,039 | |||||||||||||||
General
and administrative
|
23,474,570 | 407,673 | 421,189 | 194,043 | 192,855 | |||||||||||||||
Change
in fair value of management and incentive units
|
(6,055,483 | ) | -- | -- | -- | -- | ||||||||||||||
Total
expenses
|
72,215,268 | 1,642,154 | 1,618,892 | 674,377 | 853,270 | |||||||||||||||
Other
(income)/expenses:
|
||||||||||||||||||||
Gain
on disposal of property and equipment
|
(21,663 | ) | -- | -- | -- | -- | ||||||||||||||
Gain
on extinguishment of debt
|
(216,617 | ) | -- | -- | -- | -- | ||||||||||||||
Interest
(income)/expense, net
|
5,610,570 | 3,175 | (6,796 | ) | 1,901 | (1,325 | ) | |||||||||||||
PePenalties
associated with non-registration of Series A Preferred
Stock
|
361,495 | -- | -- | -- | -- | |||||||||||||||
Total
other (income)/expense, net
|
5,733,785 | 3,175 | (6,796 | ) | 1,901 | (1,325 | ) | |||||||||||||
Loss
before benefit from income taxes
|
(77,949,053 | ) | (1,645,329 | ) | (1,612,096 | ) | (676,278 | ) | (851,945 | ) | ||||||||||
Benefit
from income taxes
|
(547,318 | ) | -- | -- | -- | -- | ||||||||||||||
Net
loss
|
(77,401,735 | ) | (1,645,329 | ) | (1,612,096 | ) | (676,278 | ) | (851,945 | ) | ||||||||||
Preferred
Stock Dividend
|
4,341,166 | 1,195,051 | 339,765 | 413,687 | 169,191 | |||||||||||||||
Net
Loss available to common shareholders
|
$ | (81,742,901 | ) | $ | (2,840,380 | ) | $ | (1,951,861 | ) | $ | (1,089,965 | ) | $ | (1,021,136 | ) | |||||
Basic
and diluted net loss per common share
|
$ | (0.03 | ) | $ | (0.06 | ) | $ | (0.01 | ) | $ | (0.03 | ) | ||||||||
Weighted
average number of shares of
|
||||||||||||||||||||
common
stock outstanding
|
84,248,486 | 32,472,143 | 95,409,218 | 35,834,055 |
See
accompanying notes to consolidated financial statements.
4
CYTOSORBENTS
CORPORATION
(f/k/a
MedaSorb Technologies Corporation)
(a
development stage company)
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT)
Period
from
December
31, 2009 to
June
30, 2010
(Unaudited)
Members
|
Common Stock
|
Preferred Stock B
|
Preferred Stock A
|
Additional
|
Deficit
Accumulated
During the
|
Total
|
||||||||||||||||||||||||||||||||||||||
|
Equity
(Deficiency)
|
Deferred
Compensation
|
Shares
|
Par
value
|
Shares
|
Par
Value
|
Shares
|
Par
Value
|
Paid-In
Capital
|
Development
Stage
|
Stockholders'
Equity (Deficit)
|
|||||||||||||||||||||||||||||||||
Balance
at December 31, 2009
|
$
|
—
|
$
|
—
|
66,374,856
|
$
|
66,375
|
68,723.88
|
$
|
69
|
6,255,813
|
$
|
6,256
|
$
|
80,097,536
|
$
|
(78,902,521
|
)
|
$
|
1,267,715
|
||||||||||||||||||||||||
Stock
based compensation – employees, consultants and directors
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
88,645
|
—
|
88,645
|
|||||||||||||||||||||||||||||||||
Issuance
of Series A Preferred Stock as dividends
|
—
|
—
|
—
|
—
|
—
|
—
|
294,958
|
295
|
95,270
|
(95,565
|
)
|
—
|
||||||||||||||||||||||||||||||||
Issuance
of Series B Preferred Stock as dividends
|
—
|
—
|
—
|
—
|
3,237.24
|
3
|
—
|
—
|
1,099,483
|
(1,099,486
|
)
|
—
|
||||||||||||||||||||||||||||||||
Conversion
of Series A and Series B into Common
|
—
|
—
|
33,973,520
|
33,973
|
(10,370.04
|
)
|
(10
|
)
|
(532,700
|
)
|
(533
|
)
|
(33,430
|
)
|
—
|
—
|
||||||||||||||||||||||||||||
Cost
of Raising Capital
|
—
|
—
|
1,153,846
|
1,154
|
—
|
—
|
—
|
—
|
16,346
|
—
|
17,500
|
|||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(1,645,329
|
)
|
(1,645,329
|
)
|
|||||||||||||||||||||||||||||||
Balance
at June 30, 2010
|
—
|
—
|
101,502,222
|
$
|
101,502
|
61,591.08
|
$
|
62
|
6,018,071
|
$
|
6,018
|
$
|
81,363,850
|
$
|
(81,742,901
|
)
|
$
|
(271,469
|
)
|
See
accompanying notes to consolidated financial statements.
5
CYTOSORBENTS
CORPORATION
(f/k/a
MedaSorb Technologies Corporation)
(a
development stage company)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Period from
|
||||||||||||
|
January
22, 1997
|
|
|
|||||||||
(date of
|
Six
months
|
Six
months
|
||||||||||
|
inception) to
|
ended
|
ended
|
|||||||||
|
June 30, 2010
|
June 30,
2010
|
June 30,
2009
|
|||||||||
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$
|
(77,401,735
|
)
|
$
|
(1,645,329
|
)
|
$
|
(1,612,096
|
)
|
|||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Common
stock issued as inducement to convert convertible notes payable and
accrued interest
|
3,351,961
|
—
|
—
|
|||||||||
Issuance
of common stock to consultant for services
|
30,000
|
—
|
—
|
|||||||||
Depreciation
and amortization
|
2,401,300
|
8,839
|
25,277
|
|||||||||
Amortization
of debt discount
|
1,000,000
|
—
|
—
|
|||||||||
Gain
on disposal of property and equipment
|
(21,663
|
)
|
—
|
—
|
||||||||
Gain
on extinguishment of debt
|
(216,617
|
)
|
—
|
—
|
||||||||
Interest
expense paid with Series B Preferred Stock in connection with conversion
of notes payable
|
3,147
|
|||||||||||
Abandoned
patents
|
183,556
|
—
|
—
|
|||||||||
Bad
debts - employee advances
|
255,882
|
—
|
—
|
|||||||||
Contributed
technology expense
|
4,550,000
|
—
|
—
|
|||||||||
Consulting
expense
|
237,836
|
—
|
—
|
|||||||||
Management
unit expense
|
1,334,285
|
—
|
—
|
|||||||||
Expense
for issuance of warrants
|
533,648
|
—
|
—
|
|||||||||
Expense
for issuance of options
|
1,578,845
|
88,645
|
122,196
|
|||||||||
Amortization
of deferred compensation
|
74,938
|
—
|
—
|
|||||||||
Penalties
in connection with non-registration event
|
361,496
|
—
|
—
|
|||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
(350,834
|
)
|
289,805
|
50,628
|
||||||||
Other
assets
|
(56,394
|
)
|
__
|
10,240
|
||||||||
Accounts
payable and accrued expenses
|
2,881,061
|
83,479
|
(107,891
|
)
|
||||||||
Accrued
interest expense
|
1,823,103
|
—
|
—
|
|||||||||
Net
cash used by operating activities
|
(57,446,185
|
)
|
(1,174,561
|
)
|
(1,511,646
|
)
|
||||||
Cash
flows from investing activities:
|
||||||||||||
Proceeds
from sale of property and equipment
|
32,491
|
—
|
—
|
|||||||||
Purchases
of property and equipment
|
(2,226,932
|
)
|
--
|
(6,411
|
)
|
|||||||
Patent
costs
|
(451,190
|
)
|
(15,543
|
)
|
(7,150
|
)
|
||||||
Purchases
of short-term investments
|
(393,607
|
)
|
—
|
—
|
||||||||
Proceeds
from sale of short-term investments
|
393,607
|
--
|
199,607
|
|||||||||
Loan
receivable
|
(1,632,168
|
)
|
—
|
—
|
||||||||
Net
cash used by investing activities
|
(4,277,799
|
)
|
(15,543
|
)
|
186,046
|
|||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from issuance of common stock
|
400,490
|
—
|
—
|
|||||||||
Proceeds
from issuance of preferred stock
|
9,579,040
|
—
|
—
|
|||||||||
Equity
contributions - net of fees incurred
|
43,064,452
|
17,500
|
—
|
|||||||||
Proceeds
from borrowings
|
8,776,131
|
172,500
|
—
|
|||||||||
Proceeds
from subscription receivables
|
499,395
|
—
|
—
|
|||||||||
Net
cash provided by financing activities
|
62,319,508
|
190,000
|
—
|
See
accompanying notes to consolidated financial statements.
6
Net
change in cash and cash equivalents
|
595,524
|
(1,000,104
|
)
|
(1,325,600
|
)
|
|||||||
Cash
and cash equivalents - beginning of period
|
—
|
1,595,628
|
2,749,208
|
|||||||||
Cash
and cash equivalents - end of period
|
$
|
595,524
|
$
|
595,524
|
$
|
1,423,608
|
||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Cash
paid during the period for interest
|
$
|
590,189
|
$
|
—
|
$
|
—
|
||||||
Supplemental schedule of noncash investing and financing activities: | ||||||||||||
Issuance
of common stock as cost of raising capital
|
$
|
113,226
|
$
|
113,226
|
$
|
—
|
||||||
Note
payable principal and interest conversion to equity
|
$
|
10,434,319
|
$
|
—
|
$
|
—
|
||||||
Issuance
of member units for leasehold improvements
|
$
|
141,635
|
$
|
—
|
$
|
—
|
||||||
Issuance
of management units in settlement of cost of raising
capital
|
$
|
437,206
|
$
|
—
|
$
|
—
|
||||||
Change
in fair value of management units for cost of raising
capital
|
$
|
278,087
|
$
|
—
|
$
|
—
|
||||||
Exchange
of loan receivable for member units
|
$
|
1,632,168
|
$
|
—
|
$
|
—
|
||||||
Issuance
of equity in settlement of accounts payable
|
$
|
1,609,446
|
$
|
—
|
$
|
—
|
||||||
Issuance
of common stock in exchange for stock subscribed
|
$
|
399,395
|
$
|
—
|
$
|
—
|
||||||
Costs
paid from proceeds in conjunction with issuance preferred
stock
|
$
|
768,063
|
$
|
—
|
$
|
—
|
||||||
Preferred
stock dividends
|
$
|
4,341,166
|
$
|
1,195,051
|
$
|
339,765
|
||||||
Net
effect of conversion of common stock to preferred stock prior to
merger
|
$
|
559
|
$
|
—
|
$
|
—
|
During
the six months ended June 30, 2010 and 2009, 10,370.04 and 2,093.69 Series B
Preferred Shares were converted into 28,646,520 and 5,783,674 Common shares,
respectively. During the six months ended June 30, 2010 and 2009,
532,700 and 1,122,323 Series A Preferred Shares were converted into 5,327,000
and 10,473,236 Common shares, respectively. For the period from
January 22, 1997 (date of inception) to June 30, 2010, 16,998.59 Series B
Preferred Shares and 4,422,835 Series A Preferred Shares were converted into
46,957,431 and 28,751,170 Common Shares, respectively.
See
accompanying notes to consolidated financial statements.
7
CytoSorbents
Corporation
(f/k/a
MedaSorb Technologies Corporation)
Notes
to Consolidated Financial Statements
(UNAUDITED)
June
30, 2010
1. BASIS OF
PRESENTATION
The
accompanying unaudited condensed consolidated financial statements have been
prepared in accordance with the requirements of Form 10-Q of the Securities and
Exchange Commission (the “Commission”) and include the results of CytoSorbents
Corporation (the “Parent”), formerly known as MedaSorb Technologies Corporation,
and CytoSorbents, Inc. (f/k/a MedaSorb Technologies, Inc.), its wholly-owned
operating subsidiary (the “Subsidiary”), collectively referred to as “the
Company.” Accordingly, certain information and footnote disclosures required in
financial statements prepared in accordance with accounting principles generally
accepted in the United States of America have been condensed or omitted. Interim
statements are subject to possible adjustments in connection with the annual
audit of the Company's accounts for the year ended December 31, 2010. In the
opinion of the Company’s management, the accompanying unaudited consolidated
financial statements contain all adjustments (consisting only of normal
recurring adjustments) which the Company considers necessary for the fair
presentation of the Company's consolidated financial position as of June 30,
2010 and the results of its operations and cash flows for the six and three
month periods ended June 30, 2010 and 2009, and for the period January 22, 1997
(date of inception) to June 30, 2010. Results for the six and three months ended
are not necessarily indicative of results that may be expected for the entire
year. The unaudited condensed consolidated financial statements should be read
in conjunction with the audited financial statements of the Company and the
notes thereto as of and for the year ended December 31, 2009 as included in the
Company’s Form 10-K filed with the Commission on April 9, 2010.
The
accompanying consolidated financial statements have been prepared on a going
concern basis, which contemplates the realization of assets and satisfaction of
liabilities in the normal course of business. The Company has experienced
negative cash flows from operations since inception and has a deficit
accumulated during the development stage at June 30, 2010 of $81,742,901. The
Company is not currently generating revenue and is dependent on the proceeds of
present and future financings to fund its research, development and
commercialization program. The Company is continuing its fund-raising
efforts. Although the Company has historically been successful in raising
additional capital through equity and debt financings, there can be no assurance
that the Company will be successful in raising additional capital in the future
or that it will be on favorable terms. Furthermore, if the Company is
successful in raising the additional financing, there can be no assurance that
the amount will be sufficient to complete the Company's plans. These
consolidated financial statements do not include any adjustments related to the
outcome of this uncertainty.
The
Company is a development stage company and has not yet generated any revenues.
Since inception, the Company's expenses relate primarily to research and
development, organizational activities, clinical manufacturing, regulatory
compliance and operational strategic planning. Although the Company has
made advances on these matters, there can be no assurance that the Company will
continue to be successful regarding these issues, nor can there be any assurance
that the Company will successfully implement its long-term strategic
plans.
The
Company has developed an intellectual property portfolio, including 27 issued
and multiple pending patents, covering materials, methods of
production, systems incorporating the technology and multiple medical
uses.
8
2. PRINCIPAL BUSINESS ACTIVITY AND
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
Nature
of Business
The
Company, through its subsidiary, is engaged in the research, development and
commercialization of medical devices with its platform blood purification
technology incorporating a proprietary adsorbent polymer technology. The
Company is focused on developing this technology for multiple applications in
the medical field, specifically to provide improved blood purification for the
treatment of acute and chronic health complications associated with blood
toxicity. As of June 30, 2010, the Company has not commenced commercial
operations and, accordingly, is in the development stage. The Company has
yet to generate any revenue and has no assurance of future revenue.
Principles
of Consolidation
The
consolidated financial statements include the accounts of the parent,
CytoSorbents Corporation, and its wholly-owned subsidiary, CytoSorbents, Inc.
All significant intercompany transactions and balances have been eliminated in
consolidation.
Development
Stage Corporation
The
accompanying consolidated financial statements have been prepared in accordance
with the provisions of accounting and reporting by development stage
enterprises.
Cash
and Cash Equivalents
The
Company considers all highly liquid
investments purchased with an original maturity of three months or less to be
cash equivalents.
Short
Term Investments
Short-term
investments include short-term bank certificates of deposit with original
maturities of between three and twelve months. These short-term notes
are classified as held to maturity and are valued at cost, which approximates
fair value. These investments are considered Level 2 investments
under accounting standards for fair value measurements.
Property
and Equipment
Property
and equipment are recorded at cost less accumulated depreciation. Depreciation
of property and equipment is provided for by the straight-line method over the
estimated useful lives of the related assets. Leasehold improvements are
amortized over the lesser of their economic useful lives or the term of the
related leases. Gains and losses on depreciable assets retired or sold are
recognized in the statements of operations in the year of disposal. Repairs and
maintenance expenditures are expensed as incurred.
Patents
Legal
costs incurred to establish patents are capitalized. When patents are issued,
capitalized costs are amortized on the straight-line method over the related
patent term. In the event a patent is abandoned, the net book value of the
patent is written off.
Impairment
or Disposal of Long-Lived Assets
The
Company assesses the impairment of patents and other long-lived assets under
accounting standards for the impairment or disposal of long-lived assets
whenever events or changes in circumstances indicate that the carrying value may
not be recoverable. For long-lived assets to be held and used, the Company
recognizes an impairment loss only if its carrying amount is not recoverable
through its undiscounted cash flows and measures the impairment loss based on
the difference between the carrying amount and fair value.
Research
and Development
All
research and development costs, payments to laboratories and research
consultants are expensed when incurred.
Income
Taxes
Income
taxes are accounted for under the asset and liability method prescribed by
accounting standards for accounting for income taxes. Deferred income taxes are
recorded for temporary differences between financial statement carrying amounts
and the tax basis of assets and liabilities. Deferred tax assets and liabilities
reflect the tax rates expected to be in effect for the years in which the
differences are expected to reverse. A valuation allowance is provided if it is
more likely than not that some or all of the deferred tax asset will not be
realized. Under Section 382 of the Internal Revenue Code the net operating
losses generated prior to the reverse merger may be limited due to the
change in ownership. Additionally, net operating losses generated subsequent to
the reverse merger may be limited in the event of changes in
ownership.
9
The
Company follows the accounting standards associated with uncertain tax
provisions. The adoption of this standard did not have a material
impact on the Company’s consolidated statements of operations or financial
position. Upon adoption of this accounting standard, the Company had
no unrecognized tax benefits. Furthermore, the Company had no
unrecognized tax benefits at June 30, 2010. The Company files tax
returns in the U.S. federal and state jurisdictions. The Company has no open
years prior to December 31, 2006.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities. Actual results
could differ from these estimates. Significant estimates in these financials are
the valuation of options granted and the valuation of preferred shares issued as
stock dividends.
Concentration
of Credit Risk
The
Company maintains cash balances, at times, with financial institutions in excess
of amounts insured by the Federal Deposit Insurance Corporation. Management
monitors the soundness of these institutions in an effort to minimize its
collection risk of these balances.
Financial
Instruments
The
carrying values of cash and cash equivalents, short-term investments, accounts
payable, notes payable, and other debt obligations approximate their fair values
due to their short-term nature.
Net
Loss Per Common Share
Basic EPS
is computed by dividing income (loss) available to common stockholders by the
weighted average number of common shares outstanding during the period. Diluted
EPS gives effect to all dilutive potential common shares outstanding during the
period. The computation of Diluted EPS does not assume conversion, exercise or
contingent exercise of securities that would have an anti-dilutive effect on
earnings (See Note 6).
Stock-Based
Compensation
The
Company accounts for its stock-based compensation under the recognition
requirements of accounting standards for accounting for stock-based
compensation, for employees and directors whereby each option granted is valued
at fair market value on the date of grant. Under these accounting standards, the
fair value of each option is estimated on the date of grant using the
Black-Scholes option pricing model.
The
Company also follows the guidance of accounting standards for accounting for
equity instruments that are issued to other than employees for acquiring, or in
conjunction with selling, goods or services for equity instruments issued to
consultants.
Effects
of Recent Accounting Pronouncements
There
have been no recently issued accounting standards that have an impact on the
Company’s financial statements.
10
3. CONVERTIBLE NOTES
In
January 2010 the Company issued a 12-month Promissory Note in the principal
amount of $172,500, which bears interest at the rate of 5% per annum. Should the
Company complete any financing, debt or equity, which includes any equity
component or the right to convert into equity, the entire principal and
outstanding interest of the Note shall automatically be converted into the
creditor’s choice of either 1) the securities issued in such financing under the
same terms, conditions, and pricing (the “Conversion Price”) or 2) applied
toward the exercise of the creditor’s existing warrant for Series A Preferred
Stock. In addition pursuant to the terms of the Promissory Note, upon
conversion, the note holder will receive a five year warrant to purchase that
number of shares of Common Stock equal to the quotient obtained by dividing (x)
50% of the principal plus accrued interest of the Note being converted, by (y)
the Conversion Price, with the resulting number of shares having an exercise
price equal to the Conversion Price. If in the event there is not a new
financing prior to the maturity of the Note or the creditor elects to convert
the outstanding principal and interest toward the exercise of creditor’s
existing Series A warrant, then upon conversion, the note holder will receive a
five year warrant to purchase that number of shares of Common Stock equal to the
quotient obtained by dividing (x) 50% of the principal plus accrued interest of
the Note being converted, by (y) $0.10, with the resulting number of shares
having an exercise price equal to $0.10 per share of common stock.
4. STOCKHOLDERS' EQUITY
(DEFICIT)
During
the six months ended June 30, 2010 the Company recorded non-cash stock dividends
totaling $1,195,051 in connection with the issuance of 3,237.24 shares of Series
B Preferred Stock and 294,958 shares of Series A Preferred Stock as a stock
dividend to its preferred shareholders as of June 30, 2010. Effective January 1,
2010 the Company has changed its basis for estimating the fair market value of
the preferred stock dividends from the underlying conversion price of the Series
B Preferred Stock to a five day volume weighted average price of actual closing
market prices for the Company’s common stock. The financial effect of
this change in estimating the fair market value resulted in an increase of
approximately $843,000 in the non-cash charge taken for stock dividends for the
six months ended June 30, 2010.
During
the six months ended June 30, 2010 10,370.04 Series B Preferred Shares were
converted into 28,646,520 Common shares. During the six months ended
June 30, 2010 532,700 Series A Preferred Shares were converted into 5,327,000
Common shares.
During
the six months ended June 30, 2010, the Company issued stock options to
employees, consultants and directors resulting in aggregate compensation expense
of $48,747, of which $25,800 and $22,947 is presented in research and
development expenses and general and administrative expenses,
respectively.
During
the six months ended June 30, 2010, the Company incurred stock-based
compensation expense due to the amortization of unvested stock
options. The aggregate expense for the six months ended June 30, 2010
is $39,898, of which $19,154 and $20,744 is presented in research and
development expenses and general and administrative expenses,
respectively. The Company has pre-approved options to purchase in the
aggregate, up to a total of 425,000 shares of common stock to be issued and
priced at the end of December 2010 to Directors. These options have
been valued as of the pre-approval date. The aggregate expense of
these options for the six months ended June 30, 2010 is approximately $17,000,
all of which is presented in general and administrative expenses.
The
summary of the stock option activity for the six months ended June 30, 2010 is
as follows:
Weighted
|
Weighted
|
|||||
Average
|
Average
|
|||||
Exercise
|
Remaining
|
|||||
Shares
|
|
per Share
|
|
Life (Years)
|
||
Outstanding,
January 1, 2010
|
23,577,704
|
$
|
0.84
|
8.3
|
||
Granted
|
15,940,000
|
$
|
0.144
|
9.8
|
||
Cancelled
|
—
|
$
|
—
|
—
|
||
Exercised
|
—
|
$
|
—
|
—
|
||
Outstanding
June 30, 2010
|
39,517,704
|
$
|
0.56
|
8.6
|
11
The fair
value of each stock option was valued using the Black Scholes pricing model
which takes into account as of the grant date the exercise price (ranging from
$0.138 to $0.173 per share) and expected life of the stock option ( ranging from
5-10 years), the current price of the underlying stock and its expected
volatility (approximately 27 percent), expected dividends (-0- percent) on the
stock and the risk free interest rate (2.5 to 3.8 percent) for the term of the
stock option.
At June
30, 2010, the aggregate intrinsic value of options outstanding and currently
exercisable amounted to approximately $717,000.
The
summary of the status of the Company’s non-vested options for the six months
ended June 30, 2010 is as follows:
Weighted
|
||||||||
Average
|
||||||||
Grant
Date
|
||||||||
Shares
|
Fair
Value
|
|||||||
Non-vested,
January 1, 2010
|
6,801,053 | $ | 0.024 | |||||
Granted
|
15,940,000 | $ | 0.053 | |||||
Cancelled
|
— | — | ||||||
Vested
|
(4,945,909 | ) | $ | 0.038 | ||||
Exercised
|
— | — | ||||||
Non-vested,
June 30, 2010
|
17,795,144 | $ | .047 |
As of
June 30, 2010, approximately $867,000 of total unrecognized compensation cost
related to stock options is expected to be recognized over a weighted average
period of 1.5 years. Due to the uncertainty over whether certain
options granted during the six months ended June 30, 2010 will vest based on
performance milestones in the Company’s long term incentive plan, no charge for
these options has been recorded in the consolidated statements of operations for
the six months ended June 30, 2010. The Company will evaluate on an
ongoing basis the probability and likelihood of any of these performance
milestones being achieved and will accrue charges as it becomes likely that they
will be achieved.
The
Company has reserved a separate pool of 15.6 million shares of restricted stock
that may be issued to employees and directors as part of a long term incentive
plan tied to corporate objectives. As of June 30, 2010 none of these
shares have been issued and due to the uncertainty over whether they will be
issued, no charge for these shares has been recorded in the consolidated
statement of operations for the six months ended June 30, 2010.
As of
June 30, 2010, the Company has the following warrants to purchase common stock
outstanding:
Number of Shares
|
|
Warrant
Exercise
|
|
Warrant
|
|||
To be Purchased
|
|
Price per Share
|
|
Expiration Date
|
|||
816,691 |
$
|
4.98
|
June
30, 2011
|
||||
1,200,000 |
$
|
0.90
|
June
30, 2011
|
||||
900,000 |
$
|
0.40
|
June
30, 2011
|
||||
339,954 |
$
|
2.00
|
September
30, 2011
|
||||
52,080 |
$
|
2.00
|
July
31, 2011
|
||||
400,000 |
$
|
0.40
|
October
31, 2011
|
||||
240,125 |
$
|
1.25
|
October
24, 2016
|
||||
3,986,429 |
$
|
0.035
|
June
25, 2013
|
||||
397,825 |
$
|
0.0362
|
September
30, 2014
|
||||
12,483,665 |
$
|
0.107
|
October
5, 2010
|
||||
20,816,769 |
12
As of
June 30, 2010, the Company has the following warrants to purchase Series A
Preferred Stock outstanding:
Number of
|
|
Warrant
Exercise
|
|
Warrant
|
|
Shares to be
|
|
Price per
|
|
Expiration
|
|
Purchased
|
|
Preferred
Share
|
|
Date
|
|
525,000
|
$
|
1.00
|
June
30, 2011
|
If the
holder of warrants for preferred stock exercises in full, the holder will
receive additional five-year warrants to purchase a total of 210,000 shares of
common stock at $0.40 per share.
In May
2010, the Company executed a purchase agreement, or the Purchase Agreement, and
a registration rights agreement, or the Registration Rights Agreement, with
Lincoln Park Capital Fund, LLC (“LPC”). Under the Purchase Agreement,
LPC is obligated, under certain conditions, to purchase from the Company up to
$6 million of our Common Stock, from time to time over a 750 day (twenty-five
(25) monthly) period.
The
Company has the right, but not the obligation, to direct LPC to purchase up to
$6,000,000 of its Common Stock in amounts up to $50,000 as often as every two
business days under certain conditions. The Company can also accelerate the
amount of its common stock to be purchased under certain
circumstances. No sales of shares may occur at a purchase price below
$0.10 per share or without a registration statement having been declared
effective. The purchase price of the shares will be based on the
market prices of our shares at the time of sale as computed under the Purchase
Agreement without any fixed discount. The Company may at any time at
its sole discretion terminate the Purchase Agreement without fee, penalty or
cost upon one business days notice. The Company issued 1,153,846
shares of our Common Stock to LPC as a commitment fee for entering into the
agreement, and is obligated to issue up to an additional 1,153,846 shares pro
rata as LPC purchases up to $6,000,000 of its Common Stock as directed by the
Company. LPC may not assign any of its rights or obligations under
the Purchase Agreement.
13
5. COMMITMENTS AND
CONTINGENCIES
Employment
Agreements
The
Company has employment agreements with certain key executives through December
2010. The agreements provide for annual base salaries of varying
amounts.
Litigation
The
Company is currently not involved, but may at times be involved in various
claims and legal actions. Management is currently of the opinion that these
claims and legal actions would have no merit, and any ultimate outcome will
not have a material adverse impact on the consolidated financial position
of the Company and/or the results of its operations.
In
February 2008, Alkermes, Inc. commenced an action against us in the United
States District Court for the District of Massachusetts, alleging that our use
of the name MedaSorb infringes on Alkermes’ registered trademark “MEDISORB.” In
the action, Alkermes sought an injunction against our further use of the name
MedaSorb. Pursuant to a Settlement Agreement dated June 18, 2008, to avoid
any potential confusion with Alkermes’ similarly named product, the Company has
ceased using the “MedaSorb” name in its wholly-owned subsidiary, through which
the Company conducts all of its operational activities, and renamed our
operating subsidiary CytoSorbents, Inc. as of November 2008. In May 2010
the Company finalized its name change from MedaSorb Technologies Corporation to
CytoSorbents Corporation. The Company stock ticker symbol has been
changed from MSBT (OTCBB:MSBT) to CTSO (OTCBB:CTSO).
Royalty
Agreements
Pursuant
to an agreement dated August 11, 2003, an existing investor agreed to make a $4
million equity investment in the Company. These amounts were received by the
Company in 2003. In connection with this agreement, the Company granted the
investor a future royalty of 3% on all gross revenues received by the Company
from the sale of its CytoSorb device. The Company has not generated any revenue
from this product and has not incurred any royalty costs through June 30, 2010.
The amount of future revenue subject to the royalty agreement could not be
reasonably estimated nor has a liability been incurred, therefore, an accrual
for royalty payments has not been included in the consolidated financial
statements.
License
Agreements
In an
agreement dated September 1, 2006, the Company entered into a license agreement
which provides the Company the exclusive right to use its patented technology
and proprietary know how relating to adsorbent polymers for a period of 18
years. Under the terms of the agreement, CytoSorbents has agreed to pay
royalties of 2.5% to 5% on the sale of certain of its products if and when those
products are sold commercially for a term not greater than 18 years commencing
with the first sale of such product. The Company has not generated
any revenue from its products and has not incurred any royalty costs through
June 30, 2010. The amount of future revenue subject to the license agreement
could not be reasonably estimated nor has a liability been incurred, therefore,
an accrual for royalty payments has not been included in the consolidated
financial statements.
Warrant
agreement
As
inducement to invest additional funds in the private placement of Series B
Preferred Stock, additional consideration was granted to the participants of the
Series B Preferred Stock offering in the event that litigation is commenced
against CytoSorbents prior to June 30, 2018, claiming patent infringement on
certain of the Company’s issued patents. In the event this litigation
arises the Company may be required to issue warrants to purchase in the
aggregate up to a maximum of ten million shares of Common Stock subject to
certain adjustments. Through June 30, 2010 no such litigation has
arisen and due to the deemed low probability of this potential outcome; the
Company has not booked a contingent liability for this agreement.
14
6.
NET LOSS PER SHARE
Basic
loss per share and diluted loss per share for the six and three month periods
ended June 30, 2010 and 2009 have been computed by dividing the net loss for
each respective period by the weighted average number of shares outstanding
during that period. All outstanding warrants and options representing 60,334,473
and 31,228,552 incremental shares at June 30, 2010 and 2009, respectively, as
well as shares issuable upon conversion of Series A and Series B Preferred Stock
and Preferred Stock Warrants representing 190,742,332 and 232,908,744
incremental shares at June 30, 2010 and 2009, respectively, as well as potential
shares issuable upon Note conversion into Series A Preferred Stock representing
approximately 2,587,500 shares have been excluded from the computation of
diluted loss per share as they are anti-dilutive.
7.
SUBSEQUENT EVENTS
The
Company has evaluated subsequent events occurring after the balance sheet
date.
During
July and August 2010 a total of 1,406.74
shares of Series B Preferred Stock and 73,052
shares of Series A Preferred Stock were converted into 3,886,022 and
730,520 shares of Common Stock, respectively.
In August
2010 the Company issued 24-month Promissory Notes in the principal amount of
$800,000, which accrue interest at the rate of 8% per annum. Per the
terms of the Note, the investors will be repaid in equity of the Company, not
cash. During the term of the Notes, investors may at any time convert
outstanding principal and interest into Common Stock of the Company at a rate of
$0.10 per share. In addition, during the term of the Note, should the
Company complete any subsequent financing, debt or equity, in an aggregate
amount greater or equal to $750,000, which includes any equity component or the
right to convert into equity, the investor shall have the option to exchange any
outstanding principal and interest of the Note into the new
financing. Pursuant to the terms of the Promissory Note, the note
holder will receive 100% warrant coverage in the form of five year warrants to
purchase that number of shares of common stock as follows: that number of shares
of Common Stock equal to the quotient obtained by dividing (x) 50% of the
Principal, by (y) $0.10, with the resulting number of shares having an exercise
price equal to $0.10 per share of Common Stock, plus that number of shares of
Common Stock equal to the quotient obtained by dividing (x) 25% of the
Principal, by (y) $0.125, with the resulting number of shares having an exercise
price equal to $0.125 per share of Common Stock, plus that number of shares of
Common Stock equal to the quotient obtained by dividing (x) 25% of the
Principal, by (y) $0.15, with the resulting number of shares having an exercise
price equal to $0.15 per share of Common Stock. The warrants have a
cashless exercise provision. If during the term of the Note, and as
long as the Note investor continues to own an outstanding balance of the Note,
the Company has an equity financing of less than $750,000 that values the
Company on a pre-money basis at or below $35 million on a fully-diluted basis,
the Note investor will have a right of first refusal to participate in the
financing per the terms of the Note. The Promissory Notes do not have
registration rights for the shares underlying the notes or
warrants.
15
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations.
These
unaudited condensed consolidated financial statements and management’s
discussion should be read in conjunction with the audited financial statements
of the Company and the notes thereto as of and for the year ended December 31,
2009 as included in the Company’s Form 10-K filed with the Securities and
Exchange Commission (the “Commission”) on April 9, 2010.
Forward-looking
statements
Statements contained in this
Quarterly Report on Form 10-Q, other than the historical financial information,
constitute forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All such forward-looking statements
involve known and unknown risks, uncertainties or other factors which may cause
actual results, performance or achievement of the Company to be materially
different from any future results, performance or achievement expressed or
implied by such forward-looking statements. Primary risk factors include, but
are not limited to: ability to successfully develop
commercial operations; the ability to obtain adequate financing in the future
when needed; dependence on key personnel; acceptance of the Company's medical
devices in the marketplace; obtaining government approvals, including required
FDA approvals; compliance with governmental regulations; reliance on research
and testing facilities of various universities and institutions; product
liability risks; limited manufacturing experience; limited marketing, sales and
distribution experience; market acceptance of the Company's products;
competition; unexpected changes in technologies and technological advances; and
other factors detailed in the Company's Current Report on Form 10-K filed with
the Commission on April 9, 2010.
Plan
of Operations
We are a
development stage company and expect to remain so for at least the next several
quarters. We have not generated revenues to date and do not expect to do so
until we commercialize and receive the necessary regulatory approvals to sell
our proposed products. We will seek to commercialize a blood purification
technology that efficiently removes middle molecular weight toxins from
circulating blood and physiologic fluids.
We are
focusing our efforts on the commercialization of our CytoSorb™
product. The first indication for CytoSorb™ will be in the adjunctive
treatment of sepsis (bacterial infection of the blood), which causes systemic
inflammatory response syndrome. CytoSorb™ has been designed to prevent or reduce
the accumulation of high concentrations of cytokines in the bloodstream
associated with sepsis. It is intended for short term use as an adjunctive
device to the standard treatment of sepsis. To date, we have manufactured the
CytoSorb™ device on a limited basis for testing purposes, including for use in
clinical studies. We believe that current state of the art blood purification
technology (such as dialysis) is incapable of effectively clearing the toxins
intended to be adsorbed by our CytoSorb™ device.
Following
the sepsis indication, we intend to continue our research in other acute
conditions where CytoSorb™ has indicated potential in preliminary studies to
prevent or reduce the accumulation of cytokines in the bloodstream. These
conditions include, but are not limited to, the prevention of post-operative
complications of cardiac surgery (cardiopulmonary bypass surgery), damage to
organs donated for transplant prior to organ harvest, and removing drugs from
blood.
In
December 2006, we submitted a proposed pilot study for approval to the FDA with
respect to our CytoSorb™ device. In the first quarter of 2007, we received FDA
approval of our IDE application to conduct a limited study of five patients in
the adjunctive treatment of sepsis. Based on management’s belief that proceeding
with the approved limited study would add at least one year to the approval
process for the United States, we made a determination to focus our efforts on
obtaining regulatory approval in Europe before proceeding with the
FDA.
We
estimate that the market potential in Europe for our products is substantially
equivalent to that in the U.S. Given the opportunity to conduct a much larger
clinical study in Europe, and management’s belief that the path to a CE Mark
should be faster than FDA approval, we have targeted Europe as the introductory
market for our CytoSorb™ product. In July 2007 we prepared and filed a request
for a clinical trial with a German Central Ethics Committee. We received
approval of the final study design in October of 2007.
16
We are
currently approved by the German Ethics Committee to conduct a clinical study of
up to 100 patients with acute respiratory distress syndrome or acute lung injury
in the setting of sepsis. The primary endpoint of our clinical trial
is cytokine reduction and is the basis of a planned CE Mark application to
approve our device for clinical use in Europe.
After
reviewing the initial cytokine data from the first 22 patients enrolled in our
original protocol, our medical advisors recommended revisions to our protocol to
minimize non-device related artifacts that may potentially arise if the samples
are not processed or handled appropriately. The revisions to the
protocol also include a provision for testing of our targeted endpoints in
plasma instead of serum, changes in cytokine processing and analysis, additional
options for anti-coagulation that the clinical sites may use, and an increase in
the number of patients we may enroll into the study from 80 to 100.
These
changes are intended to optimize the accuracy of our cytokine data for CE Mark
submission. The proposed protocol changes and rationale for change
were submitted to the German Ethics Committee and approved. Given
these changes, cytokine data will not be statistically comparable between these
first 22 patients and those enrolled subsequently in the
study. While the company will continue to review all patient
data in the aggregate, including secondary and exploratory endpoints, the
primary use of the data from the first 22 patients will be used to support the
planned CE Mark application from a safety perspective. Cytokine
data from all patients enrolled subsequent to these first 22 patients, as well
as safety data on all patients enrolled in the study, will be used for
submission to the CE Mark authority.
By
December 31, 2009 we had initiated and opened for enrollment a total of fourteen
(14) hospital units to participate in our clinical study. To date the
Company has enrolled seventy five (75) patients in the clinical
study. We may enroll up to an additional twenty five (25)
patients. In conducting the German Clinical study we have utilized our
CytoSorb™ device in approximately 200 treatments to date with no Serious Adverse
Events attributable to the device.
The
Company has taken a number of steps to improve recruitment, the most significant
of which is the increase in the number of our clinical trial
sites. With more sites actively seeking to enroll patients, we expect
the patient enrollment rate to continue to increase going forward.
Depending
on the rate of enrollment, we expect to complete the patient enrollment between
the second half of 2010 to the first quarter of 2011. Concurrent with the
clinical study, we have commenced our preparation for the CE Mark approval
process. Assuming availability of adequate and timely funding, a successful
outcome of the study, and CE Mark regulatory approval, the Company intends to
commercialize its product in Europe.
The
clinical protocol for our European clinical study has been designed to allow us
to gather information to support future U.S. studies. In the event we receive
the CE Mark and are able to successfully commercialize our products in the
European market, we will review our plans for the United States to determine
whether to conduct clinical trials in support of 510(k) or PMA registration. No
assurance can be given that our proposed CytoSorb™ product will work as intended
or that we will be able to obtain CE Mark (or FDA) approval to sell CytoSorb™.
Even if we ultimately obtain CE Mark approval, because we cannot control the
timing of responses from regulators to our submissions, there can be no
assurance as to when such approval will be obtained.
Results
of Operations
Our
research and development costs were, $1,034,103 and $1,069,931, for the six
months ended June 30, 2010 and 2009 respectively and $352,888 and $581,376 for
the three months ended June 30, 2010 and 2009. We have experienced substantial
operating losses since inception. As of June 30, 2010, we had an accumulated
deficit of $81,742,901, which included losses of $676,278 and $1,645,329 for the
three and six month periods ended June 30, 2010. In comparison, we had losses of
$851,945 and $1,612,096 for the three and six month periods ended June 30, 2009.
Historically, our losses have resulted principally from costs incurred in the
research and development of our polymer technology, and general and
administrative expenses, which together were $546,931 and $1,441,776 for the
three and six month periods ended June 30, 2010 and $774,231 and $1,491,120 for
the three and six month periods ended Jun 30, 2009.
Off-balance Sheet
Arrangements
We have
no off-balance sheet arrangements.
Liquidity and Capital
Resources
Since
inception, our operations have been financed through the private placement of
our debt and equity securities. At December 31, 2009 we had cash of $1,595,628.
As of June 30, 2010 we had cash on hand of $595,524, and current liabilities of
$1,224,304.
We
believe that we have sufficient cash to fund our operations into the fourth
quarter of 2010, following which we will need additional funding before we can
complete our clinical studies and commercialize our products. The
Company has received SEC approval for a registration statement filed for the
funding agreement with Lincoln Park Capital Fund LLC. Subject to
minimum pricing restrictions per the terms of the funding agreement, Management
believes that the Company will be able to receive ongoing funding per the terms
of this purchase agreement (See Note 4 of Financial Statements) The agreement
with Lincoln Park has the potential to significantly extend the time that we may
be able to fund our operations. We will continue to seek funding for
the long term needs of the Company. There can be no assurance that we will be
able to utilize the Lincoln Park funding agreement, or that additional financing
will be available on acceptable terms or at all. If adequate funds are
unavailable, we may have to suspend, delay or eliminate one or more of our
research and development programs or product launches or marketing efforts or
cease operations.
17
Our
Annual Report dated December 31, 2009 was prepared assuming we will continue as
a going concern, and the auditors’ report on those financial statements
expresses substantial doubt about our ability to continue as a going
concern.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
No
reporting requirement for smaller reporting companies.
Item
4(T). Controls and Procedures.
Management's
annual report on internal control over financial reporting
Management
of CytoSorbents is responsible for establishing and maintaining adequate
internal control over financial reporting under the supervision of the President
and Chief Executive Officer and the Chief Financial Officer. Internal control
over financial reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted
accounting principles.
Management
evaluated the design and operation of our internal control over financial
reporting as of June 30, 2010, based on the framework and criteria
established in Internal
Control – Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO), and has concluded that such
internal control over financial reporting is effective. There are no material
weaknesses that have been identified by management.
An
evaluation was performed, under the supervision of, and with the participation
of, our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of the Company’s
disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-(e) to
the Securities and Exchange Act of 1934). Based on that evaluation, the
Company’s management, including our Chief Executive Officer and Chief Financial
Officer, concluded that the Company’s disclosure controls and procedures were
adequate and effective, as of June 30, 2010, to ensure that information required
to be disclosed by the Company in the reports that it files or submits under the
Securities Exchange Act of 1934, is recorded, processed, summarized, and
reported within the time periods specified in the Commission’s rules and forms,
and that such information is accumulated and communicated to management,
including our Chief Executive Officer and Chief Financial Officer, as
appropriate, to allow timely decisions regarding required
disclosure.
We do not
expect that our disclosure controls and procedures or internal control over
financial reporting will prevent all errors and all fraud. A control system, no
matter how well conceived and operated, can provide only reasonable assurance
that the objectives of the system are met and cannot detect all deviations.
Because of the inherent limitations in all control systems, no evaluation of
control can provide absolute assurance that all control issues and instances of
fraud or deviations, if any, within the Company have been detected.
This
report does not include an attestation report of the company's registered public
accounting firm regarding internal control over financial reporting.
Management's report was not subject to attestation by the company's registered
public accounting firm pursuant to temporary rules of the Securities and
Exchange Commission that permit the company to provide only management's report
in this report.
Changes
in internal control over financial reporting
There
were no significant changes in our internal controls over financial reporting
that occurred subsequent to our evaluation of our internal control over
financial reporting for the six months ended June 30, 2010 that has materially
affected, or is reasonably likely to materially affect, our internal control
over financial reporting.
18
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
The
Company is currently not involved, but may at times be involved in various
claims and legal actions. Management is currently of the opinion that these
claims and legal actions would have no merit, and any ultimate outcome will
not have a material adverse impact on the consolidated financial position
of the Company and/or the results of its operations.
In
February 2008, Alkermes, Inc. commenced an action against us in the United
States District Court for the District of Massachusetts, alleging that our use
of the name MedaSorb infringes on Alkermes’ registered trademark “MEDISORB.” In
the action, Alkermes sought an injunction against our further use of the name
MedaSorb. Pursuant to a Settlement Agreement dated June 18, 2008, to avoid
any potential confusion with Alkermes’ similarly named product, the Company has
ceased using the “MedaSorb” name in its wholly-owned subsidiary, through which
the Company conducts all of its operational activities, and renamed our
operating subsidiary CytoSorbents, Inc. as of November 2008. The Company
has also changed the name of the parent company from MedaSorb Technologies
Corporation to CytoSorbents Corporation.
Item
1A. Risk Factors
Not
required to be provided by smaller reporting companies.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. (Removed and Reserved)
None.
Item
5. Other Information
None.
Item
6. Exhibits.
Number
|
Description
|
|
31.1
|
Certification
of Phillip Chan, Chief Executive Officer of the Registrant, pursuant to
Rules 13a-14(a) and 15(d)-14(a) of the Securities Exchange Act of
1934
|
|
31.2
|
Certification
of David Lamadrid, Chief Financial Officer of the Registrant, pursuant to
Rules 13a-14(a) and 15(d)-14(a) of the Securities Exchange Act of
1934
|
|
32.1
|
Certification
of Phillip Chan, Chief Executive Officer of the Registrant, pursuant to
Rules 13a-14(B) and 15(d)-14(b) of the Securities Exchange Act of
1934
|
|
32.2
|
Certification
of David Lamadrid, Chief Financial Officer of the Registrant, pursuant to
Rules 13a-14(B) and 15(d)-14(b) of the Securities Exchange Act of
1934
|
19
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
CYTOSORBENTS
CORPORATION
|
||
Dated:
August 18, 2010
|
By:
|
/s/ David
Lamadrid
|
Name:
David Lamadrid
|
||
Title:
Chief Financial Officer
|
||
(On
behalf of the registrant and as
principal accounting
officer)
|
20