Cytosorbents Corp - Quarter Report: 2009 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,
2009
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
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)
(Former
Name, Former Address and Former Fiscal Year, 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).
Yes o No o
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 14, 2009 there were
41,520,427 shares of the issuer’s common stock outstanding.
MedaSorb
Technologies Corporation
(a
development stage company)
FORM
10-Q
TABLE
OF CONTENTS
Page
|
|
PART
I. FINANCIAL INFORMATION
|
|
Item
1. Financial Statements (June 30, 2009 and 2008 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
|
13
|
Item
3. Quantitative and Qualitative Disclosures about Market
Risk
|
14
|
Item
4(T). Controls and Procedures
|
14
|
PART
II. OTHER INFORMATION
|
|
Item
1. Legal Proceedings
|
15
|
Item
1A. Risk Factors
|
15
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
15
|
Item
3. Defaults of Senior Securities
|
15
|
Item
4. Submission of Matters to a Vote of Security Holders
|
15
|
Item
5. Other Information
|
15
|
Item
6. Exhibits
|
15
|
PART
I — FINANCIAL INFORMATION
Item 1. Financial
Statements.
MEDASORB
TECHNOLOGIES CORPORATION
(a
development stage company)
CONSOLIDATED
BALANCE SHEETS
June 30,
|
December
31,
|
|||||||
|
2009
|
2008
|
||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
and cash equivalents
|
$
|
1,423,608
|
$
|
2,749,208
|
||||
Short-term
investments
|
—
|
199,607
|
||||||
Prepaid
expenses and other current assets
|
66,375
|
117,003
|
||||||
Total
current assets
|
1,489,983
|
3,065,818
|
||||||
Property
and equipment - net
|
38,889
|
52,057
|
||||||
Other
assets
|
260,522
|
269,310
|
||||||
Total
long-term assets
|
299,411
|
321,367
|
||||||
Total
Assets
|
$
|
1,789,394
|
$
|
3,387,185
|
||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$
|
821,671
|
$
|
885,465
|
||||
Accrued
expenses and other current liabilities
|
48,142
|
92,239
|
||||||
Notes
payable
|
50,000
|
50,000
|
||||||
Total
current liabilities
|
919,813
|
1,027,704
|
||||||
Notes
payable
|
—
|
—
|
||||||
Total
long term liabilities
|
—
|
—
|
||||||
Total
liabilities
|
919,813
|
1,027,704
|
||||||
Stockholders’
Equity (Deficit):
|
||||||||
10%
Series B Preferred Stock, Par Value $0.001, 200,000 shares authorized at
June 30, 2009 and December 31, 2008, respectively; 56,247.73 and 55,558.64
shares issued and outstanding, respectively
|
56
|
55
|
||||||
10%
Series A Preferred Stock, Par Value $0.001, 12,000,000 shares authorized
at June 30, 2009 and December 31, 2008, respectively; 8,086,876 and
8,793,060 shares issued and outstanding, respectively
|
8,087
|
8,793
|
||||||
Common
Stock, Par Value $0.001, 500,000,000 Shares authorized at June 30, 2009
and December 31, 2008, respectively, 41,520,427 and 25,263,517 shares
issued and outstanding, respectively
|
41,521
|
25,264
|
||||||
Additional
paid-in capital
|
78,233,
259
|
77,786,850
|
||||||
Deficit
accumulated during the development stage
|
(77,413,342
|
)
|
(75,461,481
|
)
|
||||
Total
stockholders' equity (deficit)
|
869,581
|
2,359,481
|
||||||
Total
Liabilities and Stockholders' Equity (Deficit)
|
$
|
1,789,394
|
$
|
3,387,185
|
See
accompanying notes to consolidated financial statements.
3
MEDASORB
TECHNOLOGIES CORPORATION
(a
development stage company)
CONSOLIDATED
STATEMENTS OF
OPERATIONS
Period
from
|
||||||||||||||||||||
January
22,1997
|
||||||||||||||||||||
(date
of
inception)
to
|
Six months ended June 30, |
|
Three months ended June
30,
|
|||||||||||||||||
June
30, 2009
|
2009
|
2008
|
2009
|
2008
|
||||||||||||||||
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
||||||||||||||||
Revenue
|
$ |
--
|
$ | -- | $ | -- | $ | -- | $ | -- | ||||||||||
Expenses:
|
||||||||||||||||||||
Research
and development
|
45,361,694 | 1,069,931 | 782,563 | 581,376 | 427,436 | |||||||||||||||
Legal,
financial and other consulting
|
7,127,797 | 127,772 | 157,464 | 79,039 | 99,540 | |||||||||||||||
General
and administrative
|
22,730,636 | 421,189 | 517,884 | 192,855 | 284,320 | |||||||||||||||
Change
in fair value of management and incentive units
|
(6,055,483 | ) | -- | -- | -- | -- | ||||||||||||||
|
||||||||||||||||||||
Total
expenses
|
69,164,644 | 1,618,892 | 1,457,911 | 853,270 | 811, 296 | |||||||||||||||
Other
(income)/expenses:
|
||||||||||||||||||||
|
||||||||||||||||||||
Gain
on disposal of property and equipment
|
(21,663 | ) | -- | -- | -- | -- | ||||||||||||||
Gain
on extinguishment of debt
|
(216,617 | ) | -- | -- | -- | -- | ||||||||||||||
Interest
(income)/expense, net
|
5,592,457 | (6,796 | ) | 43,816 | (1,325 | ) | 44,341 | |||||||||||||
Penalties
associated with non-registration of Series
A Preferred Stock
|
361,495 | -- | -- | -- | -- | |||||||||||||||
Total
other (income)/expense, net
|
5,715,672 | (6,796 | ) | 43,816 | (1,325 | ) | 44,341 | |||||||||||||
Loss
before benefit from income taxes
|
(74,880,316 | ) | (1,612,096 | ) | (1,501,727 | ) | (851,945 | ) | (855,637 | ) | ||||||||||
|
||||||||||||||||||||
Benefit
from income taxes
|
(248,529 | ) | -- | -- | -- | -- | ||||||||||||||
Net
loss
|
(74,631,787 | ) | (1,612,096 | ) | (1,501,727 | ) | (851,945 | ) | (855,637 | ) | ||||||||||
Preferred
Stock Dividend
|
2,781,555 | 339,765 | 581,141 | 169,191 | 380,654 | |||||||||||||||
Net
Loss available to common shareholders
|
$ | (77,413,342 | ) | $ | (1,951,861 | ) | $ | (2,082,868 | ) | $ | (1,021,136 | ) | $ | (1,236,291 | ) | |||||
Basic
and diluted net loss per common share
|
$ | (0.06 | ) | $ | (0.08 | ) | $ | (0.03 | ) | $ | (0.05 | ) | ||||||||
Weighted
average number of shares of
|
||||||||||||||||||||
common
stock outstanding
|
32,472,143 | 25,044,932 | 35,834,055 | 25,044,932 |
See
accompanying notes to consolidated financial statements.
4
MEDASORB
TECHNOLOGIES CORPORATION
(a
development stage company)
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS'
EQUITY
(DEFICIT)
Period
from
December
31, 2008 to
June
30, 2009
(Unaudited)
Members
Equity
|
Deferred
|
Common
Stock
|
Preferred
Stock B
|
Preferred
Stock A
|
Additional
Paid-In
|
Deficit
Accumulated
During
the
Development
|
Total
Stockholders'
Equity
|
|||||||||||||||||||||||||||||||||||||
(Deficiency)
|
Compensation
|
Shares
|
Par
value
|
Shares
|
Par
Value
|
Shares
|
Par
Value
|
Capital
|
Stage
|
(Deficit)
|
||||||||||||||||||||||||||||||||||
Balance
at December 31, 2008
|
$ | -- | $ | -- | 25,263,517 | $ | 25,264 | 55,558.64 | $ | 55 | 8,793,060 | $ | 8,793 | $ | 77,786,850 | $ | (75,461,481 | ) | $ | 2,359,481 | ||||||||||||||||||||||||
Stock
based compensation – employees, consultants and directors
|
-- | -- | -- | -- | -- | -- | -- | -- | 122,196 | -- | 122,196 | |||||||||||||||||||||||||||||||||
Issuance
of Series A Preferred Stock as dividends
|
-- | -- | -- | -- | -- | -- | 416,139 | 416 | 61,071 | (61,487 | ) | -- | ||||||||||||||||||||||||||||||||
Issuance
of Series B Preferred Stock as dividends
|
-- | -- | -- | -- | 2,782.78 | 3 | -- | -- | 278,275 | (278,278 | ) | -- | ||||||||||||||||||||||||||||||||
Conversion
of Series A and Series B into Common
|
-- | -- | 16,256,910 | 16,257 | (2,093.69 | ) | (2 | ) | (1,122,323 | ) | (1,122 | ) | (15,133 | ) | -- | -- | ||||||||||||||||||||||||||||
Net
loss
|
-- | -- | -- | -- | -- | -- | -- | -- | -- | (1,612,096 | ) | (1,612,096 | ) | |||||||||||||||||||||||||||||||
Balance
at June 30, 2009
|
$ | -- | $ | -- | 41,520,427 | $ | 41,521 | 56,247.73 | $ | 56 | 8,086,876 | $ | 8,087 | $ | 78,233,259 | $ | (77,413,342 | ) | $ | 869,581 |
5
MEDASORB
TECHNOLOGIES
CORPORATION
(a
development stage company)
CONSOLIDATED
STATEMENTS OF
CASH
FLOWS
Period from
|
||||||||||||
|
January 22,1997 |
|
|
|||||||||
|
(date of
inception) to
|
Six
months ended |
Six
months ended |
|||||||||
|
June
30, 2009
|
June
30, 2009
|
June
30, 2008
|
|||||||||
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$
|
(74,631,787
|
)
|
$
|
(1,612,096
|
)
|
$
|
(1,501,727
|
)
|
|||
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
|
2,366,043
|
25,277
|
51,852
|
|||||||||
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
|
---
|
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
|
518,763
|
—
|
—
|
|||||||||
Expense
for issuance of options
|
1,375,691
|
122,196
|
251,540
|
|||||||||
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
|
(337,923
|
)
|
50,628
|
27,364
|
||||||||
Other
assets
|
(56,393
|
)
|
10,240
|
(30,000
|
)
|
|||||||
Accounts
payable and accrued expenses
|
2,689,025
|
(107,891
|
)
|
269,900
|
||||||||
Accrued
interest expense
|
1,823,103
|
—
|
—
|
|||||||||
Dividend/penalty
payable
|
—
|
—
|
—
|
|||||||||
|
||||||||||||
Net
cash used by operating activities
|
(55,108,657
|
)
|
(1,511,646
|
)
|
(887,570
|
)
|
||||||
|
||||||||||||
Cash
flows from investing activities:
|
||||||||||||
Proceeds
from sale of property and equipment
|
32,491
|
—
|
—
|
|||||||||
Purchases
of property and equipment
|
(2,226,932
|
)
|
(6,411
|
)
|
(1,316
|
)
|
||||||
Patent
costs
|
(434,880
|
)
|
(7,150
|
)
|
(8,582
|
)
|
||||||
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)/provided by investing activities
|
(4,261,489
|
)
|
186,046
|
(9,898
|
)
|
|||||||
|
||||||||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from issuance of common stock
|
400,490
|
—
|
—
|
|||||||||
Proceeds
from issuance of preferred stock
|
9,579,040
|
—
|
4,054,603
|
|||||||||
Equity
contributions - net of fees incurred
|
41,711,198
|
—
|
—
|
|||||||||
Proceeds
from borrowings
|
8,603,631
|
—
|
225,000
|
|||||||||
Proceeds
from subscription receivables
|
499,395
|
—
|
—
|
|||||||||
|
||||||||||||
Net
cash provided by financing activities
|
60,793,754
|
—
|
4,279,603
|
See
accompanying notes to consolidated financial statements.
6
Net
change in cash and cash equivalents
|
1,423,608
|
(1,325,600
|
)
|
3,382,135
|
||||||||
Cash
and cash equivalents - beginning of period
|
—
|
2,749,208
|
211,613
|
|||||||||
|
||||||||||||
Cash
and cash equivalents - end of period
|
$
|
1,423,608
|
$
|
1,423,608
|
$
|
3,593,748
|
||||||
|
||||||||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
|
||||||||||||
Cash
paid during the period for interest
|
$
|
590,189
|
$
|
—
|
$
|
—
|
||||||
Supplemental
schedule of noncash investing and financing activities:
|
||||||||||||
|
||||||||||||
Note
payable principal and interest conversion to equity
|
$
|
10,376,714
|
$
|
—
|
$
|
225,000
|
||||||
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
|
$
|
—
|
$
|
147,500
|
||||||
Preferred
stock dividends
|
$
|
2,781,555
|
$
|
339,765
|
$
|
581,141
|
||||||
Net
effect of conversion of common stock to preferred stock prior to
merger
|
$
|
559
|
$
|
—
|
$
|
—
|
During
the six months ended June 30, 2009 and 2008, 2,093.69 and -0- Series B Preferred
Shares were converted into 5,783,674 and -0- Common shares,
respectively. During the six months ended June 30, 2009 and 2008,
1,122,323 and -0- Series A Preferred Shares were converted into 10,473,236 and
-0- Common shares, respectively. For the period from January
22, 1997 (date of inception) to June 30, 2009, 2,093.69 Series B Preferred
Shares and 1,685,601 Series A Preferred Shares were converted into 5,783,674 and
11,096,978 Common Shares, respectively.
See
accompanying notes to consolidated financial statements.
7
MedaSorb
Technologies Corporation
Notes
to Consolidated Financial Statements
(UNAUDITED)
June
30, 2009
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 MedaSorb
Technologies Corporation (the “Parent”), formerly known as Gilder Enterprises,
Inc., 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, 2009. 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, 2009 and the results of its operations and cash flows for the six and
three month periods ended June 30, 2009 and 2008, and for the period January 22,
1997 (date of inception) to June 30, 2009. 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, 2008 as included in the
Company’s Form 10-K filed with the Commission on April 10, 2009.
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, 2009 of $77,413,342. 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. These
matters raise substantial doubt about the Company’s ability to continue as a
going concern. 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 26 issued
and multiple pending patents, covering materials, methods of
production, systems incorporating the technology and multiple medical
uses.
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, 2009, 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, MedaSorb
Technologies Corporation, and its wholly-owned subsidiary, CytoSorbents, Inc.
All significant intercompany transactions and balances have been eliminated in
consolidation.
8
Development
Stage Corporation
The
accompanying consolidated financial statements have been prepared in accordance
with the provisions of Statement of Financial Accounting Standard (SFAS) No. 7,
"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 SFAS 157.
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
SFAS No. 144, “Accounting 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 SFAS
No. 109, “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.
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 and other debt obligations approximate their fair values due to their
short-term nature.
Stock-Based
Compensation
The
Company accounts for its stock-based compensation under the recognition
requirements of Statement of Financial Accounting Standards (“SFAS”) No. 123(R).
“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 SFAS No. 123, 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 in EITF 96-18 “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.
9
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)
Effects
of Recent Accounting Pronouncements
In
December 2007, the FASB issued SFAS No. 141(R), “Business Combinations” (“SFAS
141(R)”). This Statement replaces SFAS No. 141, “Business Combinations” (“SFAS
141”). This Statement retains the fundamental requirements in SFAS 141 that the
acquisition method of accounting (which SFAS 141 called the purchase method) be
used for all business combinations and for an acquirer to be identified for each
business combination. This Statement also establishes principles and
requirements for how the acquirer: a) recognizes and measures in its financial
statements the identifiable assets acquired, the liabilities assumed, and any
non-controlling interest in the acquiree; b) recognizes and measures the
goodwill acquired in the business combination or a gain from a bargain purchase
and c) determines what information to disclose to enable users of the financial
statements to evaluate the nature and financial effects of the business
combination. SFAS 141(R) will apply prospectively to business combinations for
which the acquisition date is on or after the beginning of the first annual
reporting period beginning on or after December 15, 2008. An entity may not
apply it before that date. The provisions of SFAS 141(R) did not have a
significant impact on the Company's statements of operations or financial
position.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities,” and Amendment of FASB Statement No. 133. SFAS 161
amends SFAS 133, “Accounting for Derivative Instruments and Hedging Activities,”
to amend and expand the disclosure requirements of SFAS 133 to provide greater
transparency about (i) how and why an entity uses derivative instruments, (ii)
how derivative instruments and related hedge items are accounted for under SFAS
133 and its related interpretations, and (iii) how derivative instruments and
related hedged items affect an entity's financial position, results of
operations and cash flows. To meet those objectives, SFAS 161 requires
qualitative disclosures about objectives and strategies for using derivatives,
quantitative disclosures about fair value amounts of gains and losses on
derivative instruments and disclosures about credit-risk-related contingent
features in derivative agreements. SFAS 161 is effective for fiscal years and
interim periods beginning after November 15, 2008. The provisions of SFAS 161
did not have a significant impact on the Company's statements of operations or
financial position.
In May
2009, the FASB issued SFAS No. 165, Subsequent Events (“SFAS No. 165”), which
provides guidance on events that occur after the balance sheet date but prior to
the issuance of the financial statements. SFAS No. 165 distinguishes
events requiring recognition in the financial statements and those that may
require disclosure in the financial statements. Furthermore, SFAS No. 165
requires disclosure of the date through which subsequent events were evaluated.
SFAS No. 165 is effective for interim and annual periods after June 15,
2009. The Company adopted SFAS No. 165 for the quarter ended June 30,
2009, and have evaluated subsequent events through August
14, 2009.
In June
2009, the FASB issued SFAS No. 168, “The FASB Accounting Standards Codification
and the Hierarchy of Generally Accepted Accounting Principles – a replacement of
the FASB Statement No. 162.” (“SFAS No. 168”). SFAS No. 168 stipulates the FASB
Accounting Standards Codification is the source of authoritative U.S. GAAP
recognized by the FASB to be applied by nongovernmental entities. SFAS No. 168
is effective for financial statements issued for interim and annual periods
ending after September 15, 2009. The implementation of this standard
is not expected to have a material impact on our consolidated financial position
and result of operations.
3. CONVERTIBLE NOTES
The
Company has outstanding Promissory Notes in the aggregate principal amount of
$50,000, due in September 2009, which bear interest at the rate of 10% per
annum. The holder of the Promissory notes has the option to convert, on an
all-or-none basis, the entire principal and outstanding interest of their Notes
into the Series B Preferred Stock issued in June 2008. In addition,
pursuant to the terms of such Promissory Notes, upon such conversion, each note
holder will receive five-year warrants to purchase that number of shares of
Common Stock equal to the quotient obtained by dividing (x) 25% of the principal
amount of the Promissory Note being converted, by (y) $0.0362, the purchase
price per share of Common Stock issuable upon conversion of the Series B
Preferred Stock.
4. STOCKHOLDERS' EQUITY
(DEFICIT)
During
the six months ended June 30, 2009 the Company recorded non-cash stock dividends
totaling $339,765 in connection with the issuance of 2,782.78 shares of Series B
Preferred Stock and 416,139 shares of Series A Preferred Stock as a stock
dividend to its preferred shareholders as of June 30, 2009. The Company has
estimated the fair value of the shares issued as stock dividends based upon the
last completed financing transaction involving the underlying common shares in
June 2008.
During
the six months ended June 30, 2009, the Company issued stock options to
employees, consultants and directors resulting in aggregate compensation expense
of $8,378, of which $584 and $7,794 is presented in research and development
expenses and general and administrative expenses, respectively.
During
the six months ended June 30, 2009, 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, 2009
is $113,818, of which $54,070 and $59,748 is presented in research and
development expenses and general and administrative expenses,
respectively.
The
summary of the stock option activity for the six months ended June 30, 2009 is
as follows:
Weighted
|
Weighted
|
|||||||||||
Average
|
Average
|
|||||||||||
Exercise
|
Remaining
|
|||||||||||
Shares
|
per Share
|
Life (Years)
|
||||||||||
Outstanding,
January 1, 2009
|
18,158,846 | $ | 1.05 | 9.1 | ||||||||
Granted
|
5,118,858 | $ | 0.123 | 9.5 | ||||||||
Cancelled
|
— | $ | — | — | ||||||||
Exercised
|
— | $ | — | — | ||||||||
Outstanding
June 30, 2009
|
23,277,704 | $ | 0.84 | 8.8 |
10
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
$0.084 to $0.168 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 25 percent), expected dividends (-0- percent) on the
stock and the risk free interest rate (2.7 percent) for the term of the stock
option.
At June
30, 2009, the aggregate intrinsic value of options outstanding and currently
exercisable amounted to approximately $12,200.
The
summary of the status of the Company’s non-vested options for the six months
ended June 30, 2009 is as follows:
Weighted
|
||||||||
Average
|
||||||||
Grant
Date
|
||||||||
Shares
|
Fair
Value
|
|||||||
Non-vested,
January 1, 2009
|
6,280,604 | $ | 0.05 | |||||
Granted
|
5,118,858 | $ | 0.003 | |||||
Cancelled
|
— | — | ||||||
Vested
|
(4,589,075 | ) | $ | 0.041 | ||||
Exercised
|
— | — | ||||||
Non-vested,
June 30, 2009
|
6,810,387 | $ | .02 |
As of
June 30, 2009, approximately $202,000 of total unrecognized compensation cost
related to stock options is expected to be recognized over a weighted average
period of 1.15 years.
As of
June 30, 2009, 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
|
||||
15,569
|
$
|
6.64
|
March
31, 2010
|
|||
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
|
As of
June 30, 2009, 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.
As
of June 30, 2009, the Company has the following warrant to purchase Series B
Preferred Stock outstanding:
Number of
|
|
Warrant
Exercise
|
|
Warrant
|
|
Shares to be
|
|
Price per
|
|
Expiration
|
|
Purchased
|
|
Preferred
Share
|
|
Date
|
|
15,000
|
$
|
100.00
|
September
25, 2009
|
11
5. COMMITMENTS AND
CONTINGENCIES
Employment
Agreements
The
Company has employment agreements with certain key executives through December
2009. The agreements provide for annual base salaries of varying
amounts.
Litigation
The
Company is involved in various claims and legal actions. Management
is of the opinion that these claims and legal actions have no merit, and their
ultimate outcome will not have a material adverse impact on the
consolidated financial position of the Company and/or the results of its
operations.
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, 2009.
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, MedaSorb 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, 2009. 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 Medasorb 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, 2009 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.
6.
NET LOSS PER SHARE
Basic
loss per share and diluted loss per share for the six and three month periods
ended June 30, 2009 and 2008 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 31,228,552
and 26,011,346 incremental shares at June 30, 2009 and 2008, respectively, as
well as shares issuable upon conversion of Series A and Series B Preferred Stock
and Preferred Stock Warrants representing 232,908,744 and 182,285,696
incremental shares at June 30, 2009 and 2008, respectively, as well as shares
issuable upon potential long-term Note conversion into Series B Preferred Stock
and Common Warrants representing approximately 1,726,519 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
through the date of August
14, 2009, which is the date the financial statements were
issued. Based on the evaluation, the Company has determined that no
subsequent events have occurred, which require disclosure in the financial
statements.
12
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,
2008 as included in the Company’s Form 10-K filed with the Securities and
Exchange Commission (the “Commission”) on April 10, 2009.
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 10, 2009.
Plan
of Operations
We are a
development stage company and expect to remain so for at least the next twelve
months. 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 systematic inflammatory
response syndrome. CytoSorb™ has been designed to prevent or reduce the
accumulation of high concentrates 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 the prevention of post-operative complications of cardiac
surgery (cardiopulmonary bypass surgery) and damage to organs donated for
transplant prior to organ harvest. We are also exploring the potential benefits
the CytoSorb™ device may have in 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 approval from the FDA 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 decided to target Europe as the
introductory market for our CytoSorb™ product. To accomplish the European
introduction, 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.
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. By December 31, 2008 we had initiated and opened for
enrollment seven (7) hospital units to participate in our clinical study and had
identified an additional six (6) sites that may be added to our study to
accelerate enrollment. As of August 2009 the number of hospital units
participating in our study has increased to eleven (11) with an additional site
being finalized.
To date
patient enrollment has been slower than originally
anticipated. 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 increase going forward.
Concurrent with the clinical study, we have commenced preparation for the CE
Mark submission process. Management believes it will take up to
an additional 3-6 months following its submission for CE Mark approval to
receive European regulatory approval. Assuming an increase in patient
recruitment, availability of adequate and timely funding, and a successful
outcome of the study, we continue to expect to obtain CE Mark approval in
2010.
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 data from the first 22
patients enrolled in the 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 and changes in cytokine processing and
analysis. These changes are intended to optimize the accuracy of our
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 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 22 patients, as well as safety data on all patients enrolled
in the study, will be used for submission to the CE Mark
authority. The Company has recruited twenty nine (29) patients in the
clinical study to date. Management continues to anticipate that
a total of approximately 80 patients, including these 22 initial patients, will
be required to complete our study. The Company has the
flexibility to enroll up to a total of 100 patients.
13
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 a 510K 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.
Our
research and development costs were, $1,069,931 and $782,563, for the six months
ended June 30, 2009 and 2008 respectively and $581,376 and $427,436 for the
three months ended June 30, 2009 and 2008, respectively. We have experienced
substantial operating losses since inception. As of June 30, 2009, we had an
accumulated deficit of $77,413,342 which included losses of $851,945
and $1,612,096 for the three and six month periods ended June 30, 2009. In
comparison, we had losses of $855,637 and $1,501,727 for the three and six month
periods ended June 30, 2008. 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 $774,231 and
$1,491,120 for the three and six month periods ended June 30, 2009 and $711,756
and $1,300,447 for three and six month periods ended June 30,
2008.
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, 2008 we had cash of $2,749,208.
As of June 30, 2009 we had cash on hand of $1,423,608, and current liabilities
of $919,813.
We
believe that we have sufficient cash to fund our operations into
the fourth quarter of 2009, following which we will need additional funding
before we can complete our clinical studies and commercialize our
products. We will continue to seek funding for the long term needs of
the Company. There can be no assurance that 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.
Our
Annual Report dated December 31, 2008 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.
Not
applicable to smaller reporting companies.
Item 4(T). Controls and
Procedures.
Management's
annual report on internal control over financial reporting
Management
of Medasorb 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, 2009, 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, 2009, 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, 2009 that has materially
affected, or is reasonably likely to materially affect, our internal control
over financial reporting.
14
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
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, the
Company will continue to use the name MedaSorb Technologies Corporation for the
near term, but its wholly-owned subsidiary, through which the Company conducts
all of its operational activities, has ceased using the “MedaSorb” name to avoid
any potential confusion with Alkermes’ similarly named product . The operating
subsidiary has been renamed CytoSorbents, Inc. as of November
2008.
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. Submission of Matters to a Vote of Security Holders
In
February 2009, our Series B Preferred Shareholders voted to approve to waive any
Event of Default and liability due upon an Event of Default pursuant to Section
6(ix) of the Certificate of Designation of Series B Preferred Shares that shall
arise from or in connection with the occurrence of a Non-Registration Event as
provided in Section 11.4 of the Series B Subscription Agreement. The
Registration Statement has been filed but it has not been declared effective as
of the date of this filing. A copy of the Resolution of the Series B
Preferred Shareholders to Waive the Registration Penalty is attached as Exhibit
10.1 hereto.
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
|
15
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.
MEDASORB
TECHNOLOGIES CORPORATION
|
||
Dated:
August 14, 2009
|
By:
|
/s/ David
Lamadrid
|
Name:
David Lamadrid
|
||
Title:
Chief Financial Officer
|
||
(On
behalf of the registrant and as
principal accounting
officer)
|
16