Cytosorbents Corp - Quarter Report: 2008 September (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 September
30, 2008
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 is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
definition of “ large accelerated filer”, “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
November 14, 2008 there were 25,263,517 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 (September 30, 2008 and 2007 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. Controls and Procedures
|
18
|
|
|
|
PART
II. OTHER INFORMATION
|
|
|
|
Item
1. Legal Proceedings
|
18
|
|
|
|
Item
1A. Risk Factors
|
18
|
|
|
|
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
18
|
|
|
|
|
Item
3. Defaults of Senior Securities
|
18
|
|
|
|
|
Item
4. Submission of Matters to a Vote of Security Holders
|
19
|
|
|
|
|
Item
5. Other Information
|
19
|
|
|
Item
6. Exhibits
|
19
|
2
PART
I — FINANCIAL INFORMATION
Item
1. Financial Statements.
(a
development stage company)
CONSOLIDATED
BALANCE SHEETS
|
September
30,
|
December
31,
|
|||||
|
2008
|
2007
|
|||||
|
(Unaudited)
|
|
|||||
ASSETS
|
|||||||
|
|||||||
Current
Assets:
|
|||||||
Cash
and cash equivalents
|
$
|
3,375,041
|
$
|
211,613
|
|||
Prepaid
expenses and other current assets
|
154,101
|
200,682
|
|||||
|
|||||||
Total
current assets
|
3,529,142
|
412,295
|
|||||
|
|||||||
Property
and equipment - net
|
75,157
|
144,457
|
|||||
|
|||||||
Other
assets
|
274,073
|
245,820
|
|||||
|
|||||||
Total
long-term assets
|
349,230
|
390,277
|
|||||
|
|||||||
Total
Assets
|
$
|
3,878,372
|
$
|
802,572
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||||||
|
|||||||
Current
Liabilities:
|
|||||||
Accounts
payable
|
$
|
861,081
|
$
|
775,342
|
|||
Accrued
expenses and other current liabilities
|
71,421
|
131,526
|
|||||
|
|||||||
Total
current liabilities
|
932,502
|
906,868
|
|||||
Long
term liabilities:
|
|||||||
Notes
payable - non-current
|
50,000
|
—
|
|||||
Total
long term liabilities
|
50,000
|
—
|
|||||
|
|||||||
Total
liabilities
|
982,502
|
906,868
|
|||||
Commitments
and Contingencies
|
--
|
--
|
|||||
|
|||||||
Stockholders’
Equity (Deficit):
|
|||||||
10%
Series B Preferred Stock, Par Value $0.001, 200,000 and -0- shares
authorized at September 30, 2008 and December 31, 2007, respectively;
54,203.54 and -0- issued and outstanding, respectively
|
54
|
—
|
|||||
|
|||||||
10%
Series A Preferred Stock, Par Value $0.001, 12,000,000 shares authorized
at September 30, 2008 and December 31, 2007, 8,579,301 and 8,019,508
shares issued and outstanding, respectively
|
8,579
|
8,019
|
|||||
|
|||||||
Common
Stock, Par Value $0.001, 100,000,000 Shares authorized at September
30,
2008 and December 31, 2007, 25,263,517 and 25,044,932 shares issued
and
outstanding, respectively
|
25,264
|
25,045
|
|||||
|
|||||||
Additional
paid-in capital
|
77,499,878
|
71,400,849
|
|||||
Deficit
accumulated during the development stage
|
(74,637,905
|
)
|
(71,538,209
|
)
|
|||
Total
stockholders' equity (deficit)
|
2,895,870
|
(104,296
|
)
|
||||
|
|||||||
Total
Liabilities and Stockholders' Equity (Deficit)
|
$
|
3,878,372
|
$
|
802,572
|
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
|
Nine months ended September 30,
|
Three months ended September 30,
|
|||||||||||||
|
September 30, 2008
|
2008
|
2007
|
2008
|
2007
|
|||||||||||
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|||||||||||
|
|
|
|
|
|
|||||||||||
Revenue
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
|
||||||||||||||||
Expenses:
|
||||||||||||||||
|
||||||||||||||||
Research
and development
|
43,685,201
|
1,376,921
|
1,081,078
|
594,358
|
438,287
|
|||||||||||
Legal,
financial and other consulting
|
6,921,442
|
272,774
|
346,686
|
115,310
|
85,582
|
|||||||||||
General
and administrative
|
22,078,622
|
678,547
|
1,035,653
|
160,663
|
162,284
|
|||||||||||
Change
in fair value of management and incentive units
|
(6,055,483
|
)
|
—
|
—
|
—
|
—
|
||||||||||
|
||||||||||||||||
Total
expenses
|
66,629,782
|
2,328,242
|
2,463,417
|
870,331
|
686,153
|
|||||||||||
|
||||||||||||||||
Loss
from operations
|
66,629,782
|
2,328,242
|
2,463,417
|
870,331
|
686,153
|
|||||||||||
|
||||||||||||||||
Gain
on disposal of property and equipment
|
(21,663
|
)
|
—
|
—
|
—
|
—
|
||||||||||
|
||||||||||||||||
Gain
on extinguishment of debt
|
(216,617
|
)
|
—
|
(10,009
|
)
|
—
|
(3,695
|
)
|
||||||||
|
||||||||||||||||
Interest
expense (income), net
|
5,613,282
|
36,236
|
(63,494
|
)
|
(7,580
|
)
|
(14,496
|
)
|
||||||||
Penalties
associated with non-registration of Series A
Preferred Stock
|
361,495
|
—
|
361,496
|
—
|
(79,135
|
)
|
||||||||||
Net
loss
|
(72,366,279
|
)
|
(2,364,478
|
)
|
(2,751,410
|
)
|
(862,751
|
)
|
(588,827
|
)
|
||||||
Preferred
Stock Dividends
|
2,271,626
|
735,218
|
565,272
|
154,077
|
191,774
|
|||||||||||
Net
Loss available to common shareholders
|
$
|
(74,637,905
|
)
|
$
|
(3,099,696
|
)
|
$
|
(3,316,682
|
)
|
$
|
(1,016,828
|
)
|
$
|
(780,601
|
)
|
|
|
||||||||||||||||
Basic
and diluted net loss per common share
|
|
$
|
(.12
|
)
|
$
|
(.13
|
)
|
$
|
(0.04
|
)
|
$
|
(.03
|
)
|
|||
Weighted
average number of shares of common
stock outstanding
|
25,073,756
|
24,780,019
|
25,131,405
|
25,010,813
|
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,
2007
to
September 30,
2008
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
Total
|
|||||||||||||||||||||||||||
Common Stock
|
Preferred Stock B
|
Preferred Stock A
|
Additional
|
During the
|
Stockholders'
|
|||||||||||||||||||||||
Par
|
Par
|
Par
|
Paid-In
|
Development
|
Equity
|
|||||||||||||||||||||||
Shares
|
Value
|
Shares
|
Value
|
Shares
|
Value
|
Capital
|
Stage
|
(Deficit)
|
||||||||||||||||||||
Balance
at December 31, 2007
|
25,044,932
|
$
|
25,045
|
—
|
$
|
—
|
8,019,508
|
$
|
8,019
|
$
|
71,400,849
|
$
|
(71,538,209
|
)
|
$
|
(104,296
|
)
|
|||||||||||
|
||||||||||||||||||||||||||||
Stock-based
compensation - employees, consultants, and directors
|
—
|
—
|
—
|
—
|
—
|
—
|
251,540
|
—
|
251,540
|
|||||||||||||||||||
|
||||||||||||||||||||||||||||
Issuance
of Series A Preferred Stock as dividends
|
—
|
—
|
—
|
—
|
616,625
|
617
|
242,647
|
(243,264
|
)
|
—
|
||||||||||||||||||
|
||||||||||||||||||||||||||||
Issuance
of Series B Preferred Stock
|
—
|
—
|
52,931.47
|
53
|
—
|
—
|
5,657,842
|
(364,747
|
)
|
5,293,148
|
||||||||||||||||||
|
||||||||||||||||||||||||||||
Cost
of raising capital associated with issuance of Series B Preferred
Stock
|
—
|
—
|
—
|
—
|
—
|
—
|
(220,398
|
)
|
—
|
(220,398
|
)
|
|||||||||||||||||
|
||||||||||||||||||||||||||||
Issuance
of Series B Preferred Stock as Dividends
|
—
|
—
|
1,272.07
|
1
|
—
|
—
|
127,206
|
(127,207
|
)
|
—
|
)
|
|||||||||||||||||
|
||||||||||||||||||||||||||||
Issuance
of warrants upon conversion of convertible notes payable in Series
B
Preferred Stock
|
—
|
—
|
—
|
—
|
—
|
—
|
40,354
|
—
|
40,354
|
|||||||||||||||||||
Conversion
of Series A Preferred Stock into Common Stock
|
218,585
|
219
|
(56,832
|
)
|
(57
|
)
|
(162
|
)
|
—
|
|||||||||||||||||||
|
||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(2,364,478
|
)
|
(2,364,478
|
)
|
|||||||||||||||||
|
||||||||||||||||||||||||||||
Balance
at September 30, 2008 (Unaudited)
|
25,263,517
|
$
|
25,264
|
54,203.54
|
$
|
54
|
8,579,301
|
$
|
8,579
|
$
|
77,499,878
|
$
|
(74,637,905
|
)
|
$
|
2,895,870
|
See
accompanying notes to consolidated financial statements.
5
MEDASORB
TECHNOLOGIES CORPORATION
(a
development stage company)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
Period from
|
|
|
|||||||
|
January 22,1997
|
|
|
|||||||
|
(date of inception) to
|
Nine months ended
|
Nine months Ended
|
|||||||
|
September 30, 2008
|
September 30, 2008
|
September 30, 2007
|
|||||||
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|||||||
Cash
flows from operating activities:
|
|
|
|
|||||||
Net
loss
|
$
|
(72,366,279
|
)
|
$
|
(2,364,478
|
)
|
$
|
(2,751,410
|
)
|
|
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
|
2,314,840
|
77,775
|
144,931
|
|||||||
Amortization
of debt discount
|
1,000,000
|
—
|
—
|
|||||||
Gain
on disposal of property and equipment
|
(21,663
|
)
|
—
|
—
|
||||||
Gain
on extinguishment of debt
|
(216,617
|
)
|
—
|
(10,009
|
)
|
|||||
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
|
40,354
|
—
|
|||||||
Expense
for issuance of options
|
1,141,472
|
251,540
|
457,085
|
|||||||
Amortization
of deferred compensation
|
74,938
|
—
|
—
|
|||||||
Penalties
in connection with non-registration event
|
361,496
|
—
|
361,496
|
|||||||
Changes
in operating assets and liabilities:
|
||||||||||
Prepaid
expenses and other current assets
|
(425,649
|
)
|
46,581
|
(90,275
|
)
|
|||||
Other
assets
|
(76,960
|
)
|
(23,067
|
)
|
—
|
|||||
Accounts
payable and accrued expenses
|
2,751,716
|
25,637
|
(106,612
|
)
|
||||||
Accrued
interest expense
|
1,823,103
|
—
|
(70,000
|
)
|
||||||
|
||||||||||
Net
cash used by operating activities
|
(53,174,173
|
)
|
(1,942,511
|
)
|
(2,064,794
|
)
|
||||
|
||||||||||
Cash
flows from investing activities:
|
||||||||||
Proceeds
from sale of property and equipment
|
32,491
|
—
|
—
|
|||||||
Purchases
of property and equipment
|
(2,220,521
|
)
|
--
|
(21,428
|
)
|
|||||
Patent
costs
|
(419,342
|
)
|
(13,664
|
)
|
(12,258
|
)
|
||||
Loan
receivable
|
(1,632,168
|
)
|
—
|
—
|
||||||
|
||||||||||
Net
cash used by investing activities
|
(4,239,540
|
)
|
(13,664
|
)
|
(33,686
|
)
|
||||
|
||||||||||
Cash
flows from financing activities:
|
||||||||||
Proceeds
from issuance of common stock
|
400,490
|
—
|
—
|
|||||||
Net
proceeds from issuance of preferred stock
|
9,574,040
|
4,894,603
|
—
|
|||||||
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
|
60,788,754
|
5,119,603
|
—
|
Net
change in cash and cash equivalents
|
3,375,041
|
3,163,428
|
(2,098,480
|
)
|
||||||
|
||||||||||
Cash
and cash equivalents - beginning of period
|
—
|
211,613
|
2,873,138
|
|||||||
|
||||||||||
Cash
and cash equivalents - end of period
|
$
|
3,375,041
|
$
|
3,375,041
|
$
|
774,658
|
||||
|
6
Supplemental
disclosure of cash flow information:
|
||||||||||
|
||||||||||
Cash
paid during the period for interest
|
$
|
590,189
|
$
|
—
|
$
|
76,336
|
||||
|
||||||||||
Supplemental
schedule of noncash investing and financing
activities:
|
||||||||||
|
||||||||||
Note
payable principal and interest conversion to equity
|
$
|
10,376,714,
|
$
|
175,000
|
$
|
—
|
||||
|
||||||||||
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
|
$
|
—
|
$
|
23,002
|
||||
|
||||||||||
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
|
$
|
2,271,626
|
$
|
735,218
|
$
|
565,272
|
||||
|
||||||||||
Net
effect of conversion of common stock to preferred stock prior to
merger
|
$
|
559
|
$
|
—
|
$
|
—
|
See
accompanying notes to consolidated financial statements.
7
Notes
to Consolidated Financial Statements
(UNAUDITED)
September
30, 2008
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”), and MedaSorb Technologies, Inc., its
wholly-owned 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, 2008. 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 September
30, 2008 and the results of its operations and cash flows for the nine and
three
month periods ended September 30, 2008 and 2007, and for the period January
22,
1997 (date of inception) to September 30, 2008. Results for the nine 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, 2007
as
included in the Company’s Form 10-KSB filed with the Commission on April 15,
2008.
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 September 30, 2008 of $74,637,905.
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. Although the Company has historically
been successful in raising additional capital through equity and debt
financings, and completed a $5.29 million private placement of Series B 10%
Cumulative Convertible Preferred Stock (“Series B Preferred Stock”) in June and
August 2008, 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 25 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 September 30, 2008, 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, MedaSorb
Technologies, Inc. (see Note 7). 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 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.
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 (NOL)
generated prior to the June 30, 2006 reverse merger may be limited due to the
change in ownership. In addition, the Company was a limited liability company
through December 31, 2005. Consequently, all losses generated prior to December
31, 2005 are not available for utilization as an NOL for the
Company.
9
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 and considers the Company’s risk
negligible.
Financial
Instruments
The
carrying values of accounts payable and other debt obligations approximated
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.
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
Effective
January 1, 2008, the Company has adopted the provisions of SFAS No. 157, “Fair
Value Measurements” (“SFAS 157”). SFAS 157 defines fair value, establishes a
framework for measuring fair value in accordance with accounting principles
generally accepted in the United States, and expands disclosures about fair
value measurements. Any amounts recognized upon adoption as a cumulative effect
adjustment will be recorded to the opening balance of retained earnings in
the
year of adoption. The provisions of SFAS 157 did not have a significant impact
on the Company’s statements of operations or financial position.
Effective
January 1, 2008, the Company has adopted the provisions of SFAS No. 159,
“Establishing the Fair Value Option for Financial Assets and Liabilities” to
permit all entities to choose to elect to measure eligible financial instruments
and certain other items at fair value. The decision whether to elect the fair
value option may occur for each eligible items either on a specified election
date or according to a preexisting policy for specified types of eligible items.
However, that decision must also take place on a date on which criteria under
SFAS 159 occurs. Finally, the decision to elect the fair value option shall
be
made on an instrument-by-instrument basis, except in certain circumstances.
An
entity shall report unrealized gains and losses on items for which the fair
value option has been elected in earnings at each subsequent reporting date.
The
provisions of SFAS 159 did not have a significant impact on the Company’s
statements of operations or financial position.
10
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) $0.035, the purchase price per
share
of common stock issuable upon conversion of the Series B Preferred Stock. In
addition, Promissory Notes in the aggregate principal amount of $175,000 plus
accrued interest were converted into Series B Preferred Stock in June of 2008
(see Note 4, Stockholders’ Equity (Deficit)).
4.
STOCKHOLDERS'
EQUITY (DEFICIT)
In
June
2008, the Company completed an initial closing of a $4.45 million private
placement, which included the conversion of Promissory Notes in the aggregate
principal amount of $175,000 plus accrued interest. In connection with this
transaction, the Company issued 44,531.47 shares of Series B Preferred Stock.
The Company also issued a 5 year warrant to purchase 3,986,429 shares of Common
Stock at an exercise price of $0.035 per share to the holder of the Promissory
Notes in connection with their conversion into the private placement. In August
2008 the Company completed a closing of an $840,000 private placement. In
connection with this transaction, the Company issued 8,400 shares of Series
B
Preferred Stock. The purchasers of the Series B Preferred Stock at the initial
closing in June 2008 are entitled to purchase an additional $1.5 million of
Series B Preferred Stock at the same price of $100 per share (their stated
value) for a period of 15 months following the initial closing date. The Series
B Preferred Shares are initially convertible into common stock at a rate of
$0.035 per share subject to certain adjustments. As part of this transaction,
the Company incurred approximately $220,000 in costs of raising capital during
the nine months ended September 30, 2008. Pursuant to an agreement signed with
the private placement investors, the Company will file an amendment to increase
the conversion price of the Series B Preferred Stock from $0.035 to $0.0362
per
share of Common Stock. The Company has 100 million shares authorized of
preferred stock. Of this amount the Company has designated 12 million shares
as
10% Series A Preferred Stock and 200,000 shares as 10% Series B Preferred
Stock. The balance of authorized preferred shares is currently
undesignated.
Each
share of Series B Preferred Stock has a stated value of $100.00, and is
convertible at the holder’s option into that number of shares of Common Stock
equal to the stated value of such share of Series B Preferred Stock divided
by
an initial conversion price of $0.035, subject to certain adjustments.
Additionally, upon the occurrence of a stock split, stock dividend, combination
of the Common Stock into a smaller number of shares, issuance of any of shares
of Common Stock or other securities by reclassification of the Common Stock,
merger or sale of substantially all of the Company’s assets, the conversion rate
will be adjusted so that the conversion rights of the Series B Preferred Stock
stockholders will be equivalent to the conversion rights of the Series B
Preferred Stock stockholders prior to such event.
The
Series B Preferred Stock bears a dividend of 10% per annum payable quarterly;
provided, that if an “Event of Default” as defined in the Certificate of
Designation designating the Series B Preferred Stock has occurred and is then
continuing, the dividend rate increases to 20% per annum. An Event of Default
includes, but is not limited to, the following:
|
·
|
the
occurrence of “Non-Registration Events”
|
|
·
|
an
uncured breach by the Company of any material covenant, term or condition
in the Certificate of Designation or any of the related transaction
documents; and
|
|
·
|
any
money judgment or similar final process being filed against the Company
for more than $100,000.
|
11
Dividends
on the Series B Preferred Stock will be made in additional shares of Series
B
Preferred Stock, valued at the stated value thereof. Notwithstanding the
foregoing, during the first three-years following the initial closing, upon
the
approval of the holders of a majority of the Series B Preferred Stock, including
the lead investor, NJTC, if it then owns 25% of the shares of Series B Preferred
Stock initially purchased by it (the “Required Amount”), the Company may pay
dividends in cash instead of additional shares of Series B Preferred Stock,
and
after such three-year period, the holders of a majority of the Series B
Preferred Stock, including NJTC if it then owns the Required Amount, may require
that such payments be made in cash.
In
the
event of the Company’s dissolution, liquidation or winding up, the holders of
the Series B Preferred Stock will receive, in priority over the holders of
Series A Preferred Stock and Common Stock, a liquidation preference equal to
the
stated value of such shares plus accrued dividends thereon.
Holders
of Series B Preferred Stock have the right to vote on matters submitted to
the
holders of Common Stock on an as converted basis.
The
Company has agreed to file a registration statement under the Securities Act
covering the Common Stock issuable upon conversion of the Series B Preferred
Stock within 180 days following the initial closing and to cause it to become
effective within 240 days of such closing. The Company also granted the
investors demand and piggyback registration rights with respect to such Common
Stock. The investors in the private placement are entitled to liquidated damages
in an amount equal to two percent (2%) of the purchase price of the Series
B
Preferred Stock if the Company fails to timely file that registration statement
with, or have it declared effective by, the SEC.
Following
the fifth anniversary of the initial closing, the holders of a majority of
the
Series B Preferred Stock, including NJTC (if it then holds 25% of the shares
of
Series B Preferred Stock initially purchased by it) may elect to require the
Company to redeem all (but not less than all) of their shares of Series B
Preferred Stock at the original purchase price for such shares plus all accrued
and unpaid dividends whether or not declared, provided the market price of
the
Company’s Common Stock is then below the conversion price of the Series B
Preferred Stock.
Pursuant
to the Certificate of Designation designating the Series B Preferred Stock,
for
so long as NJTC holds the Required Amount, NJTC is entitled to elect (i) two
directors to the Company’s Board of Directors, which shall consist of six
members, and (ii) two members to the Company’s compensation committee, which
shall consist of at least three members. Following the initial closing, two
affiliates of NJTC joined the Company’s Board of Directors and compensation
committee pursuant to the foregoing provision.
The
transaction documents entered into with the purchasers of the Series B Preferred
Stock also provide for various penalties and fees for breaches or failures
to
comply with provisions of those documents, such as the timely payment of
dividends, delivery of stock certificates upon conversion of the Series B
Preferred Stock or exercise of the warrants, and obtaining and maintaining
an
effective registration statement with respect to the shares of Common Stock
underlying the Series B Preferred Stock and warrants sold in the
offering.
12
In
accordance with Emerging Issues Task Force (EITF) 00-27, the Company allocates
the proceeds associated with the issuance of preferred stock based on the
relative fair value of the preferred stock and warrants. Additionally, the
Company evaluates if the embedded conversion option results in a beneficial
conversion feature by comparing the relative fair value allocated to the
preferred stock to the market value of the underlying common stock subject
to
conversion. In connection with the preferred stock issuances during the nine
months ended September 30, 2008, the Company received total proceeds of
$5,293,147. The Company allocated the total proceeds in accordance with EITF
00-27 based on the related fair value as follows: $5,110,773 was allocated
to
the preferred stock and $182,374 to the warrants. Additionally, the embedded
conversion option resulted in a beneficial conversion feature in the amount
of
$182,374. In accordance with EITF 98-5, the value assigned to the warrants
resulting from the relative fair value calculation as well as the value of
the
beneficial conversion feature is recorded as a preferred stock dividend and
is
presented in the consolidated statements of operations. In addition, the Company
considers the guidance of EITF 00-19, “Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company’s Own Common
Stock,” and SFAS 133, “Accounting for Derivative Instruments and Hedging
Activities (as amended),” and concluded that the conversion feature embedded in
the preferred stock only provides for physical settlement and there are no
net
settlement features. Accordingly, the Company has concluded that the conversion
feature is not considered a derivative under EITF 00-19 and SFAS
133.
During
the nine months ended September 30, 2008 the Company recorded non-cash stock
dividends totaling $243,264 in connection with the issuance of 616,625 shares
of
Series A Preferred Stock and stock dividends totaling $127,207 in connection
with the issuance of 1,272.07 shares of Series B Preferred Stock as a stock
dividend to its preferred shareholders as of September 30, 2008. 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
which occurred in June 2008.
Pursuant
to agreements with the June 30, 2006 purchasers of Series A Preferred Stock
that
waived their rights to anti-dilution price protection upon the completion of
the
Series B offering, the Company reduced the conversion price for these holders
of
Series A Preferred Stock from $1.25 per share of Common to prices ranging from
$0.10 to $0.45 per share of Common. The June 30, 2006 purchasers of Series
A
Preferred Stock also received reductions in their corresponding warrant exercise
prices from $2.00 per share of Common Stock to exercise prices ranging from
$0.40 to $0.90 per share of Common Stock.
During
the nine months ended September 30, 2008, the Company issued stock options
to
employees, consultants and directors resulting in aggregate compensation expense
of $251,540, of which $66,662 and $184,878 is presented in research and
development expenses and general and administrative expenses,
respectively.
The
summary of the stock option activity for the nine months ended September 30,
2008 is as follows:
|
|
Weighted
|
Weighted
|
|||||||
|
|
Average
|
Average
|
|||||||
|
|
Exercise
|
Remaining
|
|||||||
|
Shares
|
per
Share
|
Life
(Years)
|
|||||||
|
|
|
|
|||||||
Outstanding,
January 1, 2008
|
2,098,502
|
$
|
9.41
|
7.7
|
||||||
Granted
|
16,018,578
|
$
|
0.075
|
9.7
|
||||||
Cancelled
|
68,638
|
$
|
26.87
|
—
|
||||||
Exercised
|
—
|
—
|
—
|
|||||||
Outstanding
September 30, 2008
|
18,048,442
|
$
|
1.06
|
9.4
|
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
$0.035 to $0.25 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 24 percent), expected dividends (-0- percent) on
the
stock and the risk free interest rate (approximately 4 percent) for the term
of
the stock option.
At
September 30, 2008, the aggregate intrinsic value of options outstanding and
currently exercisable amounted to approximately $10,000.
The
summary of the status of the Company’s non-vested options for the nine months
ended September 30, 2008 is as follows:
13
|
Shares
|
Weighted
Average
Grant
Date
Fair
Value
|
|||||
|
|
|
|||||
Non-vested,
January 1, 2008
|
173,330
|
$
|
.80
|
||||
Granted
|
16,018,578
|
$
|
.03
|
||||
Cancelled
|
—
|
—
|
|||||
Vested
|
9,868,639
|
$
|
.03
|
||||
Exercised
|
—
|
—
|
|||||
Non-vested,
September 30, 2008
|
6,323,269
|
$
|
.06
|
As
of
September 30, 2008, approximately $418,000 of total unrecognized compensation
cost related to stock options is expected to be recognized over a weighted
average period of 1.42 years.
As
of
September 30, 2008, the Company has the following warrants to purchase common
stock outstanding:
Number of Shares
To be Purchased
|
Warrant
Exercise
Price per Share
|
Warrant
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
|
$
|
2.00
|
October
24, 2016
|
||||
3,986,429
|
$
|
0.035
|
June
25, 2013
|
As
of
September 30, 2008, the Company has the following warrants to purchase Series
B
Preferred Stock outstanding:
Number of Series B
Shares to be
Purchased
|
Warrant
Exercise
Price per
Preferred
Share
|
Warrant
Expiration
Date
|
|||||
15,000
|
$
|
100.00
|
September
25, 2009
|
14
As
of
September 30, 2008, the Company has the following warrants to purchase Series
A
Preferred Stock outstanding:
Number of Series A
Shares to be
Purchased
|
Warrant
Exercise
Price per
Preferred
Share
|
Warrant
Expiration
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 $2.00 per share.
5.
COMMITMENTS
AND CONTINGENCIES
Employment
Agreements
The
Company has employment agreements with certain key executives through December
2008. The agreements provide for annual base salaries of varying
amounts.
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 September
30,
2008. 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 September 30, 2008. 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.
Company
Name Change
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 a similarly named product of the other party to such
agreement.
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
September 30, 2008 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 nine months ended September
30, 2008 and 2007 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 25,999,290 and
5,925,299 incremental shares at September 30, 2008 and 2007, respectively,
as
well as shares issuable upon conversion of Series A and Series B Preferred
Stock
and Preferred Stock Warrants representing 235,067,262 and 6,889,126 incremental
shares at September 30, 2008 and 2007, respectively, have been excluded from
the
computation of diluted loss per share as they are anti-dilutive.
15
7.
SUBSEQUENT EVENTS
Effective
November 2008 the Company has changed the name of its wholly owned operating
subsidiary to CytoSorbents, Inc.
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,
2007 as included in the Company’s Form 10-KSB filed with the Securities and
Exchange Commission (the “Commission”) on April 15, 2008.
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-KSB filed with the Commission on April 15,
2008.
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, which we
believe will provide a relatively faster regulatory pathway to market. 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.
16
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 CytoSorb™, the first device we intend to bring to market. 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 have targeted Europe for the initial
market introduction of our CytoSorb™ product. To accomplish the European
introduction, in July 2007 we prepared and filed a request for a clinical trial
with German regulators. We received approval of the final study design in
October of 2007. The clinical study allows for enrollment of up to 80 patients
with acute respiratory distress syndrome or acute lung injury in the setting
of
sepsis. We have made arrangements with several hospitals in Germany to conduct
the clinical studies, and to date, have enrolled thirteen patients in the study.
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 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, $1,376,921 and $1,081,078, for the nine
months ended September 30, 2008 and 2007 respectively, and $594,358 and $438,287
for the three months ended September 30, 2008 and 2007, respectively. We have
experienced substantial operating losses since inception. As of September 30,
2008, we had an accumulated deficit of $74,637,905 which included losses from
operations of $870,331 and $2,328,242 for the three and nine month periods
ended
September 30, 2008. In comparison, we had losses from operations of $686,153
and
$2,463,417 for the three and nine month periods ended September 30, 2007.
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 $755,021 and $2,055,468 for the
three and nine month periods ended September 30, 2008.
Liquidity
and Capital Resources
Since
inception, our operations have been financed through the private placement
of
our debt and equity securities. At December 31, 2007 we had cash of $211,613.
As
of September 30, 2008 we had cash on hand of $3,375,041, and current liabilities
of $932,502. Our increase in cash from December 31, 2007 is a result of the
June
and August 2008 $5.29 million private placement of Series B Preferred Stock,
which is further described in Note 4 to the consolidated financial statements.
Notwithstanding the closing of the private placement, we will require additional
funding before we are able to commercialize our products and 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.
Due
to
our losses and lack of available cash at that time, our audited consolidated
financial statements for the year ended December 31, 2007 have been 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.
Off-balance
Sheet Arrangements
We
have
no off-balance sheet arrangements.
17
Item
3. Quantitative and Qualitative Disclosures About Market
Risk.
Not
applicable to smaller reporting companies.
Item
4. Controls and Procedures.
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 September 30, 2008, 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.
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 nine months ended September 30, 2008 that has
materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
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
On
June
25, 2008, we
sold
(i) 44,531.47
shares
of our Series B Preferred Stock, at a price of $100 per share which includes
a
note payable and accrued interest converted into the offering and (ii) a
security to purchase additional shares of Series B Preferred Stock within 15
months following the Initial Closing at $100 per share, to a group of twelve
accredited investors led by NJTC
Venture Fund SBIC, L.P. (“NJTC”). On August 25, 2008, we sold 8,400 shares of
our Series B Preferred Stock, at a price of $100 per share to a group of seven
accredited investors. This
offering was a private offering exempt from registration pursuant to Section
4(2) and Regulation D (Rule 506) under the Securities Act of 1933, as amended
(the “Securities Act”).
Item
3. Defaults Upon Senior Securities
None.
18
Item
4. Submission of Matters to a Vote of Security Holders
On
October 29, 2008, our shareholders adopted a resolution authorizing us to
increase the number of our authorized shares of common stock to 500,000,000.
A
preliminary information statement on Schedule 14C was filed with the SEC on
November 6, 2008 and will be mailed to all shareholders of record as of the
date
of filing the definitive information statement. The preliminary information
statement filed on Schedule 14C on November 6, 2008 is referred to and
incorporated herein by reference.
Item
5. Other Information
On
October 22, 2008, Al Kraus tendered a letter of resignation effective December
31, 2008. Mr. Kraus will be resigning from his position as the Chief Executive
Officer but will remain on the Board of Directors. Dr. Philip Chan was appointed
to replace Mr. Kraus as the Chief Executive Officer. For more information please
refer to the Form 8-k filed on October 30, 2008 which is referred to and
incorporated herein by reference.
Item
6. Exhibits.
Number
|
|
Description
|
|
|
|
31.1
|
|
Certification
of Al Kraus, 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 Al Kraus, 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.
|
|
|
|
MEDASORB
TECHNOLOGIES CORPORATION
|
|
|
|
|
Dated:
November 14, 2008
|
By:
|
/s/ David
Lamadrid
|
|
Name:
David Lamadrid
|
|
|
Title:
Chief Financial Officer
|
|
|
(On
behalf of the registrant and as
principal
accounting officer)
|
EXHIBIT
INDEX
Number
|
|
Description
|
|
|
|
31.1
|
|
Certification
of Al Kraus, 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 Al Kraus, 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
|
20